cyrilzakka/clinical-trials huggingface dataset:
Jogging in the Change of Osteoporosis

To test the changes in osteoarthritis according to the X-rays, and changes in bone quality before and 1 or more years after beginning the jogging

Patients in this research are given an entry Bone Densitometry（DEXA）scan and are required to advance from 3-minute jogging a day to 10-minute level in daily practice for 1 year as instructed. After 1 year, subsequent DEXA scans are recorded. Interested participants are also encouraged to have hip and spine X-rays, and bone quality studies on study entry and two years later. Actual subject participation, intercurrent illnesses, fractures and changes in medication are self-monitored. Results are calculated by change in bone mineral density in the lumbar spine, hips and femurs by the DEXA scan in the study. Dose-response relationships between the amount of jogging and bone mineral density are sought. Jogging-related fractures and other adverse effects are also noted.

Eligibility Criteria:
Inclusion Criteria:

Past DEXA scan and, all within 6 months of study entry, DEXA scan and normal values for: Metabolic panel, TSH, PTH, ESR (or CRP), Vitamin D 25 hydroxy, Vitamin D 1,25 dihydroxy, Urine NTX

Exclusion Criteria:

Known metabolic bone disease such as osteogenesis imperfecta, current treatment with steroids, chemotherapy, or currently healing fractures of lumbar spine, hips or femurs, severe heart disease
Trial of L-DOPA as a Treatment to Improve Vision in Albinism

This project will evaluate the effect of two doses of levodopa (L-DOPA) in a randomized, placebo-controlled, double-masked clinical trial to see if vision can be improved in individuals with albinism. The hypothesis is that providing L-DOPA to the retinas of these individuals may increase melanin pigment production. Increased melanin has previously been shown to be associated with improved vision.

A group of 45 individuals with the clinical findings of oculocutaneous albinism (OCA) will be randomly assigned to one of 3 treatment groups: treatment with 0.76 mg/kg/d with 25% carbidopa, 0.51 mg/kg/d levodopa with 25% carbidopa \[divided into 3 doses/d), or placebo. Subjects will be between ages 3 and 60 years. Blood will be drawn to determine the mutation(s) in the genes that causes OCA. Primary outcome will be binocular best-corrected visual acuity measured with the EVA. Enrollment and 20 week examination will be complete eye exam with fundus photos. At weeks 5, 10, and 15, exams will include just vital signs and BCVA. At all visits, a review of potential side effects will be conducted. Between visits, subjects will be contacted to determine if any side effects have occurred. The study will remain double masked until the last study examination on the last subject has been performed. At that time, the data will be statistically analyzed and subjects will be informed re: treatment assignment, mutations found, and the study results.

Eligibility Criteria:
Inclusion Criteria:

* Age 3 to 60 years with albinism

Exclusion Criteria:

* Glaucoma or at increased risk of glaucoma
* History of dystonia
* History of melanoma
* Planning to undergo eye muscle surgery during study time frame
* Undergoing vision therapy
* Taking iron supplements or vitamins with iron
* Taking medication for ADHD
* Known liver or gastrointestinal disease
* Previous treatment with levodopa
* Psychological problems
* Ocular abnormalities other than those associated with albinism
* Pregnant, nursing or planning to become pregnant during study
* Known allergy to levodopa/carbidopa
Therapy Pathways in the Treatment of Hormone Naïve Prostate Cancer Patients With and Without Comorbidities Treated With Degarelix or Luteinizing-Hormone-Releasing-Hormone (LHRH) Agonists.

The purpose of this study is to detect factors influencing decision making for treatment pathways of hormone-naïve prostate cancer patients with and without comorbidities receiving medicinal androgen deprivation therapy (Degarelix or LHRH agonists).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Prostate Cancer and indicated for ADT according to Summary of Product Characteristics (SmPC)
* Decision made to prescribe ADT (Degarelix or LHRH agonist) prior to enrolment

Exclusion Criteria:

* Patient had previous or is currently under hormonal management of Prostate Cancer, except for a curative intention, where the duration of the neoadjuvant/adjuvant therapy did not exceed 6 months and treatment should have been terminated at least 6 months prior to baseline.
* Participation in a clinical trial at baseline and during the follow-up period
Innovation for Small-scale Experiments: ReceptIVFity Test

The ReceptIVFity acts as a timing-tool for prediction of optimal pregnancy chances and provides insight into the patient's current (two months after sampling) success rate of an IVF/IVF-ICSI treatment. Benefits of physician decision treatment in case of an unfavorable vaginal profile and a low chance of achieving a pregnancy include reducing unnecessary morbidity and treatment cycles, stress and disappointment, while increasing efficacy of the treatment and lowering the costs needed to achieve a pregnancy.

The goal of this prospective, clinical non-invasive randomized controlled study, with an additional observational study arm (for women of non-European origin) in naïve IVF or IVF/ICSI patients is to evaluate the efficiency of Shared Decision Making compared to Physician Decision in terms of

1. the success probability of an IVF cycle,
2. the proportion of women with a successful pregnancy
3. the number of unsuccessful IVF cycles.

Randomization component Women of European origin will be randomized 1:1 to either the shared decision group or the physician decision group. All women of European origin may undergo one to three cycles of IVF/IVF-ICSI reimbursed by the health insurance. The follow-up ends after the outcome of the last of these cycles has been determined. The desired outcome of the IVF or IVF/ICSI treatment is a successful pregnancy, i.e., a pregnancy with a heart-beat at 12 weeks of gestation.

Observational component Women of non-European origin are invited to take part in an observational component of this study. Without further evaluation of the results of their vaginal microbiome, they will continue with the IVF/IVF-ICSI cycle. Women eligible for participation are naïve patients and the follow-up ends after the outcome of the first IVF/IVF-ICSI cycle has been determined.


Eligibility Criteria:
Inclusion Criteria:

1. Naïve IVF or IVF/ICSI patients
2. Indication for an IVF or IVF-ICSI procedure.
3. 18 years \< age \< 43 years.
4. Willing to provide a vaginal swab with the ReceptIVFity test.
5. Willing to provide informed consent.

Exclusion Criteria:

1. The use of hormonal contraceptives at the time of taking the test.
2. The use of antibiotic treatment at the time of taking the test.
3. Emergency IVF for cancer or other reasons.
4. Women with endometriosis pre-treated with an Gn-RH analogue.
5. Women having IVF for egg preservation reasons.
Ice Plant Intensive Cream for the Prevention of Hand-Foot Syndrome in Breast Cancer: Pilot Randomized Controlled Trial

The present pilot study investigates the feasibility of a prospective larger confirmatory study on the efficacy of Dr. Hauschka Med Ice Plant Intensive Cream for the prevention of hand-foot syndrome in patients with breast carcinoma undergoing therapy with doxorubicin and / or docetaxel.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients
* Therapy with Doxorubicin and/or Docetaxel
* Karnofsky performance status scale \> 80
* Informed consent

Exclusion Criteria:

* Patients with previous skin disease and/or polyneuropathy
* Intolerance or allergic reaction on at least one ingredient of Ice Plant Intensive Cream
* Already receiving chemotherapy
* Usage of Ice Plant Intensive Cream before trial
* Severe physical or psychological illness due to which the patient is not able to participate in the study
* Lack of German language skills
Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients

Purpose of the study :

To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically or cytologically proven diagnostic of Primary CNS lymphoma
* All histological types of non-Hodgkin's lymphoma, except MALT
* Age \> 18 and \< 60 ans.
* Negative for HIV, HCV and HBV
* Written informed consent -

Exclusion Criteria:

* Age \< 18 or \> 60 ans
* Isolated intra-ocular lymphoma
* Previous history of indolent lymphoma
* Previous chemotherapy or radiotherapy for PCNSL
* Isolated CNS relapse of systemic NHL
* Previous history of cancer in the last 5 years, except basocellular carcinoma and non invasive cervix cancer
* Renal insufficiency or creatinin clearance \< 60 ml/min
* Liver enzymes \> 3N.
* Platelets \< 100 000/mm3 or neutrophils \< 1500/mm3)
* Previous history of organ transplantation or other cause of severe immunodeficiency
* Pregnancy or active sexual women with no contraception
* Unable to follow the protocol for any reason
Adverse Event Prediction in Geriatric Patients in the ED With Ultrasound

The aim of this study is to evaluate whether ultrasound measurements of the Qcsa can be utilized to identify older patients who are at risk for functional decline, ED revisit or death.

Background:

Older people visit the Emergency Department (ED) more frequently then younger people and have a higher risk of functional decline, ED revisit or death. Several screening tools (such as the Dutch safety management system (VMS) and Acutely Presenting Older Patient (APOP)) have been developed to identify patients at the highest risk of adverse outcomes. Almost all require adequate communication with the patient, which is not always possible, for example when elderly patients present with a delirium. Point of Care Ultrasonography (POCUS) may be a valuable alternative screening tool in these instances.

Main research question:

To identify whether POCUS measurement of the rectus femoris muscle cross-sectional area (Qcsa) can be used as an alternative screening tool to predict functional decline, ED revisit or death in elderly patients in the ED.

Design (including population, confounders/outcomes):

This is a single centre prospective trial. Patients \>70 years and older presenting in the ED of the University Medical Centre Groningen (UMCG) who are participating in the Acutelines bio-databank are eligible for inclusion. 68 patients will be included. Data will be extracted from the Acutelines bio-databank. A trained physician will perform ultrasound measurements in a standardized way.

Expected results:

The aim of this study is to evaluate whether ultrasound measurements of the Qcsa can be utilized to identify older patients who are at risk for functional decline, ED revisit or death.

Eligibility Criteria:
Inclusion Criteria:

* Age (\>70 years)
* Presenting to the ED of the UMCG for one of the following specialties: internal medicine, nephrology, geriatric medicine, oncology, hematology, lung medicine, gastrointestinal/liver medicine, or emergency medicine (non-trauma).
* Consent obtained for participation in the Acutelines bio-databank

Exclusion Criteria:

* Unable to obtain ultrasound image of rectus femoris (e.g. amputation, edema)
* Paresis or paralysis of one or both legs
Therapeutic Exposures and Risk Factors in MRONJ

This study focuses on patients who have developed a condition called medication-related osteonecrosis of the jaw (MRONJ), which can occur after using certain medications. The purpose is to closely monitor these patients over time to better understand how they are diagnosed, treated, and followed up. By doing this, researchers hope to uncover how different factors such as a patient's background, lifestyle, and other health conditions might influence their recovery and overall quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 and over
* Male or female individuals
* Individuals who apply to the Marmara University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery due to medication-related osteonecrosis of jaw during the study period
* Individuals or their legal representatives who have given written consent to participate in the study

Exclusion Criteria:

* Non-drug-related osteonecrosis/osteomyelitis
* Osteoradionecrosis
* Metastasis to the oral region
* Individuals who have not given written consent to participate in the study
* Individuals under the age of 18
Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers

To Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral single dose of JP-1366 tablet in Healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* A healthy adult aged between 19 and 45 years old
* BMI between 18.0kg/m2 and 27.0kg/m2 at the time of screening

Exclusion Criteria:

* The subject who has clinically significant disease with liver, endocrine system, immune system, nervous system, kidney, cardiovascular disease, mental disorder, the blood of tumor disease, respiratory system or with history of the disease.
* The subject who has a history of gastrointestinal disorders(e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or history of gastrointestinal surgery
* The subject who has an allergic disease(excluding mild allergic rhinitis that does not require administration) or has a history of clinically significant hypersensitivity or adverse reactions to clinical trial drugs or drugs containing the same or other drugs (aspirin, NSAIDs, antibiotics, etc.).
* The subject who has other clinically significant diseases or history
* The subject who has a history of drug abuse
* The subject who cannot withstand the insertion and maintenance of pH catheters
The Time Delay Correlated With LV Functions and Heart Failure Incidence in STEMI?!

To find out if the time delays between the first medical contacts till the device has an impact on LV functions estimated by transthoracic Echocardiography and if it's correlated to heart failure incidence in non-diabetic patients with STEMI treated with primary PCI


Eligibility Criteria:
Inclusion Criteria:

* Subjects with anterior STEMI according to ESC guidelines 2017.
* Subjects undergoing PPCI for the first time .
* Non diabetic patients.

Exclusion Criteria:

* • Patients with previous PCI.

  * Patients with previous CABG.
  * Patients with TIMI flow II or less .
  * Cardiogenic shock.
18842 - Sun Protection Factor Assay

To evaluate the Sun Protection Factor (SPF) efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Effect of Food on Bioavailability of Modified Release Formulations of Imatinib

This study will evaluate the effect of food on the relative bioavailability of a single dose of imatinib given as a 800 mg modified release tablet, compared to twice-daily doses of 400 mg film-coated tablets. There will be a 8 day wash out phase between treatments and a 1 week safety period at the end of the study. Each participant will receive all four treatments.


Eligibility Criteria:
Inclusion criteria

* Healthy male or female subjects (postmenopausal women), 18-65 years of age
* Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion criteria

* Smokers within 3 months
* Subjects using any prescription drug or over-the-counter (OTC) medication (including herbal and alternative medication) within 3 weeks prior to dosing.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* A past medical history or presence of clinically significant ECG abnormalities
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
* History of medications pre-disposing the subjects for GI bleedings/cerebral hemorrhage.
* Women taking any biphosphonates (Fosomax like drugs)
* History of being immunocompromised, including a positive HIV test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* Females nursing infants. Other protocol-defined inclusion/exclusion criteria may apply.
Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment

The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Histologic or cytologic confirmed diagnosis of HCC
* Advanced disease defined as (i) disease not eligible for surgical or loco-regional therapy or (ii) disease progressive after surgical or loco-regional therapy
* Patient has failed ≥ 14 days of Sorafenib treatment
* Cirrhotic status of Child-Pugh Class A or B with a score of 7
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
* Subjects who have a life expectancy of at least 8 weeks
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy
* Previous or concurrent cancer that is distinct in primary site
* History of active cardiac disease
* Thrombotic or embolic events within the past 6 months
* Any other hemorrhage/bleeding event \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks
* Inability to swallow tablets or untreated malabsorption syndrome
* History of human immunodeficiency virus (HIV) infection
* Prior use of systemic investigational agents for HCC (except for Sorafenib)
Hunter Outcome Survey (HOS)

The purpose of this study is to collect data that will increase understanding of Hunter syndrome. The data from HOS may provide guidance to healthcare professionals about disease treatment options.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Hunter syndrome (biochemically and/or genetically)
2. Signed and dated written informed consent, as per either a or b below:

   1. Prospective Participants: Signed and dated written informed consent from the participant or, for participants aged less than (\<) 18 years (\<16 years in Scotland), parent and/or participant's legally authorized representative (LAR), and assent of the minor where applicable.

      informed consent must be obtained from LARs for cognitively impaired participants, where applicable.

      OR
   2. Historical Participants: Signed and dated informed consent from the participant's LAR (where allowed by relevant individual country or site regulations/laws). .

Exclusion Criteria:

1. Participants enrolled in an interventional clinical trial are not eligible. Participants may re-enroll once they have completed or withdrawn from the other clinical study.
2. Participants receiving treatment for Hunter syndrome with an ERT product other than Elaprase are not eligible. Participants may enroll or re-enroll once they have stopped treatment with another ERT.
Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension

The objective of this randomized control trial is to gain clinical insight on the use of pulmonary artery denervation (PADN) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of PADN for the treatment of PAH.

The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in 6-minute walk distance (6MWD) of PADN on PAH patients. Based on the previous studies, the 6MWD was 13±24 m after 6-month treatment using target drugs. And our previous data showed that 6MWD at 6-month after PADN procedure was 65±85 m. As a result, a total of 128 patients with Group I PAH are randomized at a ratio of 1:1 to either PADN procedure plus phosphodiesterase-5 inhibitors (PDE5i) group (PADN group) or sham-PADN procedure plus PDE5i group (Sham group) using a randomization schedule blocked by site. The combination therapy of PDE5i with additional other PAH-specific target drugs is not recommended for all patients and is left at physician's discretion in both groups.

Eligibility Criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures; Men and women 18 years and older; Group I PAH, defined as a mPAP≥25mmHg, PCWP\<15mmHg and PVR\[The PVR =(mPAP-PCWP)/CO\]\>3.0 Woods unit.

Exclusion Criteria:

General exclusion criteria:

Pregnancy and breast feeding mother; Estimated life expectancy \< 12 months; Scheduled major surgery in the next 6 months; Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk; Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days.

Procedural exclusion criteria:

WHO group II, III, IV, V PH Severe Renal dysfunction (Ccr\<30 ml/min) Blood platelet count\<100,000/L Expected life span\<6-month Systematical inflammation Malignant cancer(s) Tricuspid valve stenosis, Supra-pulmonary valve stenosis Allergic to studied drugs or metal materials.
Comparative Analysis of Short-Term Therapeutic Effects Between the π-Shaped and Overlap Methods for Esophagogastrostomy in Totally Laparoscopic Total Gastrectomy

As of now, although the safety of π-shaped anastomosis and the overlap method has been separately discussed in different contexts, there have been few studies considering a direct comparison of the results of these two methods.

This article aims to explore the differences in the short-term therapeutic effects, surgical effectiveness, and safety between laparoscopic total gastrectomy with esophagogastrostomy using the overlap method and the π-shaped method. The goal is to provide new reference points for surgeons in the clinical decision-making process regarding the choice of anastomotic techniques during totally laparoscopic total gastrectomy.


Eligibility Criteria:
Inclusion Criteria:(1) preoperative confirmation through electronic gastroscopy and enhanced CT that the lesion was situated in the fundus, middle and upper third of the gastric body, or the entire stomach; (2) postoperative pathology confirming adenocarcinoma; (3) utilization of either overlap esophagojejunal anastomosis or π-shaped anastomosis in total laparoscopic total gastrectomy.

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Exclusion Criteria:(1) patients with severe preoperative cardiac, hepatic, renal, and pulmonary complications; (2) preoperative neoadjuvant chemotherapy; (3) a history of previous abdominal surgery; (4) patients requiring combined resection due to infiltration of other organs during the operation; (5) patients with incomplete pathological or clinical data. All patients signed informed consent.

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