cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia

This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
* Willingness to have micro-dot-tattoo applied to scalp
* Willingness to maintain same hair style, length and hair color during study

Exclusion Criteria:

* Drug or alcohol abuse within 12 months
* HIV positive
* Received hair transplants or had scalp reductions
* Use of hair weaves, hair extensions or wigs within 3 months
* Oral or topical minoxidil treatment within 6 months
* Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Total-Body FDG PET for Radiotherapy Response Assessment in Head and Neck Cancer

The overall goal of this research study is to understand how 18F-fluorodeoxyglucose (FDG), a radioactive sugar behaves in head and neck cancer (HNC) and inflammation immediately following injection and at many hours post-injection, with the world's first total-body positron emission tomography (PET)/computed tomography (CT) scanner (EXPLORER).


Eligibility Criteria:
Inclusion Criteria:

1. Stage II-IVa (American Joint Committee on Cancer, 8th edition) OC who are planned for RT (≥60 Gy) as per routine clinical standard.
2. Patient must be ≥18 years of age.
3. Willing and able to lay motionless in a supine position for up to 60 minutes
4. Patient must be able to provide study specific informed consent prior to study entry.
5. Patient must be able to adhere to the study visit schedule and other protocol requirements (including prolonged fasting).

Exclusion Criteria:

1. Prior RT for any malignancy leading to overlap with planned RT fields.
2. Prior chemotherapy for any malignancy.
3. Subjects suffering from severe claustrophobia.
4. Subjects who have had a research study involving radiation within one year of enrolling in this study
5. Subjects who are pregnant (subjects 18 to 60 years old who are able to become pregnant unless documented hysterectomy or bilateral ovarian removal is available will be tested prior to injection of imaging agent - positive test will exclude from participating in the study)
6. Subjects who are breastfeeding
7. Prisoners.
8. Any significant medical condition that in the opinion of the investigator would prevent the subject from participating and/or adhering to study related procedures or interfere with subject safety (e.g., poorly controlled diabetes).
9. Children (\<18 years of age).
10. Body weight more than 240 kg (529 pounds)

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Bioavailability and Pharmacodynamics of EPA and DHA From Fortified Soymilk and Capsules

This study will compare the algae oil fortified soymilk to a commercial algae oil capsule containing the same base oil with the goal of demonstrating equivalent or greater accumulation of EPA and DHA in blood lipid pools.

Research shows that fish oil and its component fatty acids EPA and DHA provide health benefits such as reducing the risk of cardiac death and lowering inflammation. Yet a large portion of the population is not consuming the recommended amount of fish due to high cost, dietary restrictions such as vegetarianism/veganism, concerns about high levels of mercury, general dislike, and other factors. Additionally, to meet the recommendations fish and fish oil production present sustainability challenges. A potential alternative is to utilize EPA and DHA from algae. These sustainable oils can be added to foods increasing the potential for fatty acids to counteract chronic disease and increasing access to general consumers. Previously, our lab has developed, and optimized EPA and DHA fortified non-dairy plant milk beverages utilizing algae oil emulsions (food grade). Up to 0.4% algae oil can be added to soymilk with limited changes to overall liking. This study will compare the algae oil fortified soymilk to a commercial algae oil capsule containing the same base oil with the goal of demonstrating equivalent or greater accumulation of EPA and DHA in blood lipid pools. Subjects will consume either one beverage or two capsules per day, containing equivalent amounts of EPA and DHA. Blood will be taken at 4 time points throughout the 6 week study, every two weeks and analyzed for EPA and DHA in different lipid types. Additionally, participants will complete a food frequency questionnaire to evaluate their normal diet, sensory evaluation (overall liking, and attribute evaluation) of the beverages, and daily symptom and intake logs to track consumption and any side effects.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18 and 30 kg/m2

Exclusion Criteria:

* Being pregnant or nursing
* Having anemia or a condition that influences the ability to donate blood safely
* Allergies to the beverage or pill ingredients
* Diabetes
* High triglycerides or cholesterol
* Coagulation disorder
* Anticoagulation therapy or any drug that affects blood clotting.
* Taking prescribed dietary omega-3 fatty acid medications including fish oil or algae oil within the last 3 months
* Taking non-prescribed dietary omega-3 fatty acid supplements within the last 3 months and not willing to discontinue taking them for the study period
* Taking lipid lowering medications such as statins
* Sensory impairments which affect ability to taste, smell, or see food products
Registry for Hypoparathyroidism Wuerzburg

Long-term conventional treatment of chronic hypoparathyroidism does not fully restore calcium homeostasis leading to increased morbidity, emergency events and reduced subjective health status. To further investigate general morbidity, hypocalcemic events, subjective and daily life performance in patients with chronic hypoparathyroidism a standardized interview as well as blood sampling and examinations such as echocardiography and renal ultrasound are performed.

Design:

In a longitudinal prospective trial the comorbidities, mortality, hypocalcemic and hypercalcemic events and quality of life in patients with chronic hypoparathyroidism will be evaluated by a standardized interview, blood sampling and further examinations such as echocardiography and renal ultrasound.

Patients:

Patients will be recruited out of the patient population of the University Hospital Wuerzburg.

Statistical Analysis:

Documentation and analysis will be performed at the Department of Medicine I, Endocrine and Diabetes Unit, University of Würzburg, Germany. Data will be documented after pseudonymisation in a data base. For further analysis data will be compared to sex- and age-matched controls.

Eligibility Criteria:
Inclusion Criteria:

* age of 18
* chronic hypoparathyroidism (\>12 months) under established therapy or chronic pseudohypoparathyroidism (\>12 months) under established therapy
* written informed consent

Exclusion Criteria:

* age \<18 years
* no detailed documentation of hypo- or pseudohypoparathyroidism
Influence of an Exercise Program in the Elderly Balance

This study has the objective to determinate the effectiveness of a specific exercise program on balance and functional capacity of the daily activities of institutionalized elderly.

It was a randomized controlled trial with a total of 21 elderly that were randomly distributed into experimental (n = 11) and control groups (n=10). The experimental group performed a specific program exercises during 4 weeks, while the control group wasn't subjected to any intervention. Evaluations were carried out at the beginning and end of the exercise program, for both groups. After the intervention there were no statistically significant differences between groups in total balance and dynamic balance subscale, except static balance subscale.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* institutionalized elderly
* Both genders
* Mini-Mental ≥19 pontos
* Protocol attendance ≥ 90%

Exclusion Criteria:

* Cardiovascular diseases
* Contraindication to physical exercise
* Medication (anxiolytics, antidepressants)
* Vestibular disorders
* Previous physiotherapy of 6 months to the present study
* Neurological and neuromuscular diseases
* Use of gaiters
* Another type of physical exercise during the study
Analysis of the Impact of Cholecystectomy on Gut Microbiome in Adults

Laparoscopic cholecystectomy (LC) is widely used in the gallbladder stone, gallbladder polyp, gallbladder cancer and other diseases. Some of the patients would develop diarrhea after surgery, and studies have reported an increased risk of colorectal cancer after LC. The aim of the present study was to examine the effects of LC on the gut microbiota.


Eligibility Criteria:
Inclusion Criteria:

1. Gallbladder polyps diameter mm \>10;
2. The history of the symptoms of patients with gallbladder stones, there was no history of acute attack in the past month;
3. Age \<70 years old;
4. No serious systemic diseases such as diabetes, hypertension, heart disease, lung disease and so on/American anesthesia Association (ASA) grade I or II;
5. BMI\<30;
6. Families have better care and observation, and away from the hospital within 1 hours; patients and their families understand the process of ambulatory surgery (24 hours) and the pros and cons.

Exclusion Criteria:

1. Less than 18 years old;
2. With previous gastric surgery ;
3. Major systemic diseases ;
4. Pregnancy or lactation;
5. The use of antibiotics or yogurt within 2 months before the study.
Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.

All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic breast cancer confirmed by biopsy
* No more than one prior chemotherapy regimen for metastatic breast cancer
* Able to perform activities of daily living with minimal assistance
* Adequate bone marrow, liver and kidney function
* Age 18 years or older
* Give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Moderate to severe peripheral neuropathy
* Uncontrolled blood pressure or uncontrolled heart beat irregularities
* Diabetes Mellitus with fasting blood sugar greater than 200 mg %
* Significant heart disease within the prior 6 months
* Severe or uncontrolled medical disease
* Active uncontrolled infection
* Known chronic liver disease
* Known diagnosis of HIV infection
* Pregnant or breast feeding females

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Bioequivalency Study of Meloxicam Tablets Under Fasting Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Meloxicam or any comparable or similar product.
Exploring the Effect of the Transcendental Meditation® Technique on Migraine Frequency and Functionality: a Single Arm Study

This research will explore the effect of the Transcendental Meditation® Technique on migraine intensity and frequency. It will be a single-arm pilot study involving 30 participants recruited from migraine treatment facilities and support groups in the US.

The objective of this study is to assess the safety, feasibility, and effects of the practice of the Transcendental Meditation technique in adults with migraines. This study will involve 30 participants recruited from migraine treatment facilities and migraine support groups in the US. The study will span three months, with all participants practicing Transcendental Meditation (TM) while continuing their usual lifestyle and medication regimen. Pre-data will be collected through symptom analysis, headache patterns, and evaluation questionnaires. All potential subjects will keep a daily migraine diary for 30 days before inclusion in the study, both to assess migraine status and to adhere to study protocols during the study. All the subjects will receive TM instruction, followed by bi-weekly group meetings and one-on-one sessions for 3 months to monitor progress and ensure correct practice.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of migraine with or without aura, based on ICHD3 criteria
* 6-14 migraine days/month.
* ≥ one-year history of migraines starting before the age of 50.
* ≥ 18 years old or ≤ 60 Years old
* Willing to attend follow-up sessions.
* Willing to practice TM twice a day for 20 minutes.
* Fluent in English.

Willing to continue the same medication without any additional medicine

In good general health, with no other diseases expected to interfere with the study.

Exclusion criteria:

* \> 60 years old or \< 18 Years old
* Already practicing Transcendental Meditation.
* Pre-diagnosed major systemic illness or unstable medical/psychiatric condition (eg, suicide risk) requiring immediate treatment or that could compromise protocol adherence
* Medication overuse headache (MOH)
* Current/planned pregnancy or breastfeeding
* New prophylactic migraine medicine started within 4 weeks of the screening visit
* Unwilling to maintain stable migraine medication dosages
* Failure to complete baseline headache logs.
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention

The present trial is addressing the question if a biologically distinct subgroup of ischemic stroke patients without known atrial fibrillation at admission, selected by a cut-off level of MRproANP concentration, which represents a underlying increased risk of cardiac thrombogenicity, benefits from direct oral anticoagulation (DOAC) within 7 days of symptom onset versus standard of care (antiplatelet) as preventive treatment.

Three DOACs with marketing authorisation in Switzerland and the EU for the prevention of stroke and systemic embolism in patients with atrial fibrillation can be used. Eligible patients will be randomly assigned to either the standard of care (control) or the experimental (direct start with DOAC) arm with a ratio of 1:1. Each study participant will be observed during a follow up period within one year after index stroke.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ischemic stroke
* level ≥200pmol/L within 72 hours from symptom onset
* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria:

* History of AF, AF on 12-lead ECG on admission or any AF ≥30 seconds during heart-rhythm monitoring prior to randomization
* Other condition that require anticoagulant therapy (e.g., venous thromboembolism) as per Investigator's judgment including therapeutical dose of low-molecular-weight heparin or heparin
* Strong likelihood to be treated with prolonged (i.e. more than 30 days) dual antiplatelet therapy during the course of the trial (such as coronary stenting, etc.)
* Patients undergoing planned procedures where therapy with a DOAC is a contraindication (e.g. surgery)
* Previous intracranial hemorrhage in the last year
* Evidence of severe cerebral amyloid angiopathy if MRI scan performed
* Chronic kidney disease with creatinin clearance \<30ml/min and or subject who requires haemodialysis or peritoneal dialysis
* Known bleeding diathesis (e.g. active peptic ulcer disease , platelet count \< 100'000/mm3 or haemoglobin \< 9 g/dl or INR ≥ 1.7, documented haemorrhagic tendencies or blood dyscrasias)
* Active infective endocarditis
* CT or MRI evidence of cerebral vasculitis
* Known allergy or intolerance to antiplatelets or DOACs
* Female who is pregnant or lactating or has a positive pregnancy test at time of admission
* Current participation in another drug trial
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Very Severe Chronic Fatigue Syndrome

Based on pilot patient observations, and experience from the prior study KTS-1-2008, the investigators anticipate that severely affected chronic fatigue syndrome patients may benefit from B-cell depletion therapy using Rituximab induction with maintenance treatment.

The hypothesis is that at least a subset of chronic fatigue syndrome (CFS) patients have an activated immune system involving B-lymphocytes, and that prolonged B-cell depletion may alleviate symptoms.

An approved amendment (April 15th 2011): the study will be extended with up to 5 patients. For up to 5 patients in the study, standard plasma exchange may be performed 2-3 weeks prior to start of B-lymphocyte depletion using Rituximab (as in the protocol).

Approved amendment (December 2011): for patients with gradual improvement in CFS/ME symptoms after 12 months follow-up, but not having reached a clear response, up to 6 additional Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months period.


Eligibility Criteria:
Inclusion Criteria:

* patients severely affected by chronic fatigue syndrome, in WHO performance status III or IV.
* age 18-66 years
* informed consent

Exclusion Criteria:

* patients with fatigue, not fulfilling criteria for CFS
* pregnancy or lactation
* previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
* previous major immunological disease, except autoimmune diseases such as diabetes mellitus or thyroiditis
* endogenous depression
* lack of ability to comply by the protocol
* multi-allergy with risk of serious drug reaction
* reduced renal function (creatinin \> 1.5 x upper normal limit \[UNL\])
* reduced liver function (bilirubin or transaminases \> 1.5 x UNL)
* HIV positivity
* evidence of clinically significant infection
Role of Natural Light in the Prevention of Delirium After Cardiac Surgery: a Prospective Observational Study With Historical Control

Postoperative delirium is a common complication that usually occurs acutely within the first 24 hours after surgery and resolves within 72 hours; it is common in all medical areas and particularly affects patients over the age of 65 and those with pre-existing cognitive impairments. It is characterized by difficulty organizing and coordinating thoughts and by slowing down motor functions that are observed for a short period after surgery.

The study will be an observational prospective study with historical control (pre/post-study) whose primary objective is to identify the incidence of postoperative delirium in patients undergoing cardiac surgery. The population will be adult patients undergoing cardiac surgery at our University Hospital over a period of 12 months. The intervention will be exposure to totally artificial light (for patients hospitalized after the relocation of the department to its original location). The comparator will be exposure to natural light (for patients who will be hospitalized during our temporary transfer to an environment with natural lighting). The outcome will be the incidence of delirium, measured with the Confusion Assessment Method-Intensive Care Unit (CAM-ICU) scale; episodes of agitation requiring sedative drugs; time elapsed before onset of delirium. The study will last 12 months.


Eligibility Criteria:
Inclusion Criteria:

* planned cardiac surgery
* planned ICU admission after surgery

Exclusion Criteria:

* cardiac surgery with total suspension of cerebral perfusion
* patient with diagnosed dementia or major depressive disorder
* patient unable to perform CAM-ICU evaluation
* emergent surgery
* patient in ICU before surgery
Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer

The purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second line treatment in patients with Advanced or Metastatic Gastric Cancer (A/MGC).

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of sorafenib in primary hepatic carcinoma and renal cancer, we design this clinical trial to evaluate the efficacy, time to progression and overall survival of sorafenib for A/MGC patients as a second line treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
* ECOG performance scale ≤ 2
* At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
* Adequate hepatic, renal, heart, and hematologic functions:

  * platelets\>80 × 109/L
  * neutrophil\>2.0 × 109/L
  * serum creatinine ≤ 1.5mg/dl
  * total bilirubin within upper limit of normal(ULN)
  * serum transaminase ≤ 2.5 × the ULN

Exclusion Criteria:

* Pregnant or lactating women
* Concurrent cancer
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Neuropathy, brain, or leptomeningeal involvement
* Uncontrolled significant comorbid conditions and previous radiotherapy