cyrilzakka/clinical-trials huggingface dataset:
Changes of Pain Sensitivity During Rehabilitation of Patients Suffering From Whiplash Associated Disorders

This study investigates the sensory profile of people suffering from whiplash associated disorders (WAD) during rehabilitation.

Altered pain sensitivity is commonly reported in WAD populations when compared to a healthy control group but how/if this changes over time during rehabilitation is unclear. This study investigates the effect of 2 weeks rehabilitation protocol on pain sensitivity in a group suffering from WAD compared to a healthy control group.

Eligibility Criteria:
Inclusion Criteria:

WAD

* No more than 3 weeks since MVA/WAD
* WAD grade II defined by Quebec Task Force classification

Controls • Being healthy and free from any pain specific to the low back and/or in general

Exclusion Criteria:

Applies for both groups:

* Pain related to a specific pathology such as spinal stenosis, metastasis, fracture, nerve lesions or injuries to the brain etc.
* Previous painful condition (including neck pain) in the previous 6 months.
* Prior surgery in the neck or shoulder area.
* Radiculopathy.
* Multiple painful sites/areas unrelated to the neck pain.
* Operation to the spine.
* Any neurological or systemic diseases which can affect the outcome measures.
* Pregnancy.
* Lack of ability to cooperate.

Additional exclusion criteria for Controls:

• No current or previous history of on-going pain, defined as pain in the neck/shoulder region and/or elsewhere during the past 6 months.
Development and Validation of a Telemonitoring System for High-risk Cardiovascular Patients

Development and validation of a telemonitoring system for high-risk cardiovascular patients.

The main purpose of this study is to investigate the beneficial effect of continuous telemonitoring in patients with cardiovascular diseases in different clinical settings (hospitalized patients, ambulant patients, patients during cardiac rehabilitation,...) Beside established risk parameters such as HRV (heart rate variability) and DC (Deceleration Capacity) new risk stratification models should be established from the continuously recorded biosignals.


Eligibility Criteria:
Inclusion Criteria:

* decidable male and female patients \> 18 years of age
* cardiovascular disease with at least one of the following criteria:
* LVEF ≤ 40%
* cardiac autonomic dysfunction
* St. p. myocardial infarction
* St. p. cardiopulmonary resuscitation
* St. p. pulmonalartery embolism
* St. p. decompensated heart failure
* Informed consent for participation in the clinical trial

Exclusion Criteria:

* missing informed consent
* pregnant and breast-feeding women
HDDO-1614 Intervention Trial

Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study


Eligibility Criteria:
Inclusion Criteria:

* Body weight 50kg ≤ / BMI=18\~29kg/㎡
* A person who is determined to be eligible for the test through a physical examination or an interview
* Those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, urine test, serology test

Exclusion Criteria:

* Patients with clinically significant liver, pancreas, kidney, nervous system, respiratory, endocrine, hematologic, mental, cardiovascular
* Patients with a history of gastrointestinal disorders or history of gastrointestinal surgery that may affect the absorption of pharmaceuticals for clinical trials
* Any person who shows any of the following results in the screening test

  1. AST or ALT \> 2 times upper limit of normal range
  2. Total Bilirubin \> 2.0mg/dL
  3. Glomerular filtration rate (eGFR) \< 60mL / min/ 1.7㎡
* Those who show signs of hypotension (systolic blood pressure ≤ 100mmHg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
* Those who have a history of drug abuse or who have a positive urine drug test
Entire-body PET Scans for Multiple Sclerosis

To evaluate whether an entire-body positron emission tomography (PET) scanner can be exploited to improve evaluation, monitoring and measurement of both peripheral and central demyelination in multiple sclerosis (MS) patients.

To collect exploratory data using the most recent PET-CT scanners with their increased detection sensitivity and spatial resolution for the evaluation of F18-florbetapir radiopharmaceutical uptake in the nervous system of the entire body with special attention to correlation of radiotracer activity levels in the myelinated, demyelinated, or remyelinated white matter of multiple sclerosis (MS) patients compared to normal healthy subjects. The pilot study will be conducted on 20 participants as a clinical research trial of PET amyloid and myelin imaging with the primary objective of identifying possible differences in F18-florbetapir radiotracer activity for MS patients compared to normal healthy subjects, and the secondary objective of monitoring psychological health of those participants who elect to be informed of imaging results and who complete a panel of psychometric scales before and after imaging results disclosure.

Eligibility Criteria:
Inclusion Criteria:

* Multiple sclerosis (MS) patients diagnosed by a credentialed neurologist experienced with care of multiple sclerosis patients.
* Normal healthy subjects.
* Willing and able to lie motionless on the PET-CT scanner bed for at least 10 minutes and up to 20 minutes for the duration of the PET-CT medical imaging scan.

Exclusion Criteria:

* Any additional complicating medical illness other than MS including any other neuropsychiatric illness unrelated to MS diagnosed prior to the onset of initial symptoms of MS.
* Pregnancy or breast feeding.
* Diabetes or other metabolic-endocrine disorders.
* Any known concomitant acute infection.
* History of metastatic or locally invasive cancer.
* Recent surgery, chemotherapy or radiation therapy.
Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension

The primary hypothesis of this study is that glutamine supplementation will improve the erythrocyte glutamine/glutamate ratio, a biomarker of oxidative stress, hemolysis and pulmonary hypertension (PH) in sickle cell disease (SCD) and thalassemia (Thal) patients with PH. PH is defined as a tricuspid regurgitant jet velocity (TRV) on Doppler echocardiography \> 2.5 m/s. We also predict that glutamine therapy will increase arginine bioavailability and subsequently alter sickle red cell endothelial interaction that can be identified using endo-PAT technology through nitric oxide (NO) generation, leading to changes in biological markers, and clinical outcome. Specifically our second hypothesis is that oral glutamine will decrease biomarkers of hemolysis and adhesion molecules, and improve the imbalanced arginine-to-ornithine ratio that occurs in hemolytic anemias, leading to improved arginine bioavailability and clinical endpoints of endothelial dysfunction and PH in patients with SCD and Thal.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of SCD (Hb SS, SC or SBeta- thalassemia) or Thal
* PH documented by echocardiography, defined as at TRV greater than 2.5 m/s
* Age greater than or equal to 4 years

Exclusion Criteria:

* Inability to take or tolerate oral medication
* Acute crisis or hospitalization within 1 month of enrollment
* Hepatic dysfunction (SGPT greater than 3X normal)
* Renal dysfunction (Creatinine greater than 2X normal)
* Allergy to glutamine
* Pregnancy or breastfeeding
* Patients on sildenafil (Viagra), calcium channel blockers, or amino acid/protein supplements (other therapies acceptable if stable more than 3 months)
Andosan in Allergic and Asthma Patients

Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with asthma and allergy, undergoing allergen specific immunotherapy experience clinical and biochemical improvement in their disease.

A prospective randomised study comparing the mushroom extract with placebo.

Asthma and allergy are increasing in Norway and Western countries. Treatment is still mostly symptomatic. Extracts of the immunomodulatory and edible mushroom Agaricus blazei, such as Andosan™, have been shown to protect against asthma and allergy in murine models by changing the T helper cell 1(upregulation)-T helper cell 2 (downregulation) balance in the immune system. Positive effects on allergy were also shown in a RCT on blood donors with selfreported allergy. Andosan™ is produced in Japan and approved as food (mushroom juice) in Norway.

The aim of this study is to examine whether Andosan™ i) has similar clinical effects against allergy and asthma in patients as it has in mice, and as earlier shown in a study on blood donors with allergy ii) wether patients taking Andosan has any clinical impact on asthma while taken as supplementary treatment in addition to other medication compared to a placebo group while going through allergen specific immunotherapy (ASIT).

If the extract shows effect on these patients it support the hypotheses that Andosan helps against atopic diseases and facilitate the shift from Th-2 to Th-1 responses at a cellular level.

Eligibility Criteria:
Inclusion Criteria:

* Asthma or allergy patients that are eligible for ASIT (Allergen specific immunotherapy).
* Age above 18.
* Able to understand written and oral Norwegian

Exclusion Criteria:

- none other than not meeting the inclusion criteria
A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC

This is a multicenter, open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability and define the RP2D of MT-303 in participants with advanced hepatocellular carcinoma expressing GPC3.

MT-303 will be administered intravenously with treatment provided until lack of tolerability or progression. Participants will be enrolled in sequential dose escalation cohorts with determination of dose limiting toxicities with the goal of establishing the (maximum tolerated dose) MTD and (Recommended Phase 2 dose) RP2D.

Eligibility Criteria:
Inclusion Criteria

* Aged 18 years or older
* Histological diagnosis of advanced/recurrent or metastatic and/or unresectable HCC. \[Note: participants with other tumor types expressing GPC3 may be eligible pending a discussion with the Medical Monitor\]
* Measurable lesion per RECIST 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
* Child-Pugh score: Class A
* Adequate organ function

Exclusion Criteria

* Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis.
* Any acute illness including active infection
* History of liver transplantation or on waiting list
* Participants with untreated or incompletely treated varices with bleeding or high risk for bleeding
* Uncontrolled pleural effusion, pericardial effusion, or ascites
* History of symptomatic congestive heart failure
* History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.
Comparison of the Safety of Absorbable and Hem-o-lok Clips in Laparoscopic Cholecystectomy

Safe closure of the cystic duct is the critical step in laparoscopic cholecystectomy. In the literature, the investigators did not observe any prospective study analysing the use of absorbable single clip and Hem-o-lok single clip. In this prospective study, the reliability of the two methods will be compared using a single clip.

In this prospective randomised controlled clinical study; closure of the cystic duct in laparoscopic cholecystectomy will be performed by two different methods. Early clinical results and long-term effects on neighbouring anatomical structures will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic cholecystectomy ASA I-III Patients who accepted the study

Exclusion Criteria:

* open surgery emergency cholecystectomy refuse to trial
Analgesic Effect of Levobupivacaine in Breast Augmentation

The purpose of this study is to determine whether levobupivacaine is effective in the acute postoperative pain treatment in periprosthetic breast augmentation

One of the most common plastic surgery is breast augmentation using prosthesis ( mammoplasty Surgery with cohesive silicone gel prosthesis insubpectoral plane). Remains challenging management of acute postoperative pain that allows for early discharge of patients. To this end the following objectives are proposed: evaluate the analgesic efficacy of L-Bupivacaine 0.25% vs. Placebo (saline) administered irrigation into the surgical pocket bilaterally intraoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Women\> 18 and \<= 65 years
* Mammoplasty Surgery with cohesive silicone gel prosthesis in subpectoral plane
* ASA I and II
* Informed consent signed

Exclusion Criteria:

* Rejection of the patient
* ASA III or higher
* Other conditions that warrant their inclusion as medically indicated (eg psychiatric illness).
* Allergy to NSAIDs, local anesthetics and / or morphine
* Patients treated for chronic pain
* Placement of drains for surgical needs
Effectiveness of Toric Intraocular Lenses for Treating Corneal Astigmatism in Patients With Cataract and Previous DALK

the purpose of this study was to assess the efficacy of custom made toric intraocular lens implantation in patients with simultaneous post-DALK high corneal astigmatism and cataract.

Patients undergoing cataract surgery after DALK for keratoconus were enrolled. Total corneal astigmatism (TCA)was assessed by a rotating Scheimpflug camera combined with Placido disk corneal topography (Sirius; CSO, Firenze, Italy). A customized toric IOL (FIL 611 T, Soleko) was implanted in all eyes. One year postoperatively, refraction was measured, the IOL position was recorded, and vectorial and non-vectorial analysis were performed to evaluate the correction of astigmatism.

Eligibility Criteria:
Inclusion Criteria:

* Corneal suture removal had been performed in all cases at least 1 year before cataract surgery.

Corneal astigmatism was stable at least since 6 months before the cataract surgery

Exclusion Criteria:

* other ocular pathologies as glaucoma, retinal disease.
Molecular Basis of Langerhans and Non-Langerhans Cell Histiocytic Neoplasms and Castleman Disease

The purpose of this study is to use agnostic genomic evaluation using whole exome sequencing (WES) of a variety of rare hematologic diseases grouped under rare blood diseases and its variants to further elucidate the understanding of the chemistry of these disorders and identify potential actionable mutations that can be targeted with therapies in the context of clinical trials.

The study team will examine genetic changes, also known as mutations, in the DNA of participants' blood, or if applicable, bone marrow specimen. These types of tests are increasingly used by doctors to improve the accuracy of diagnosis and make decisions during care. This study seeks to understand how many patients will benefit from this testing, and in what ways. The results of this portion of the study are placed in the individual's medical record and are communicated back to each participant.

Eligibility Criteria:
Inclusion Criteria:

* Must have histopathologic confirmation of the particular rare hematologic disease.
* Diseases that will be considered as rare hematologic diseases for this study will include the following

  * Langerhans cell histiocytosis (LCH)
  * Erdhiem Chester disease (ECD)
  * Rosai-Dorfman disease (RDD)
  * Miscellaneous histiocytic entities -indeterminate dendritic cell tumor, interdigitating dendritic cell sarcoma, follicular dendritic cell sarcoma, fibroblastic reticular cell tumor
  * Unicentric Castleman disease
  * Multicentric Castleman disease including TAFRO
  * Follicular Dendritic Cell sarcoma (FDCS)
* Newly diagnosed treatment naïve patients as well as patients who received prior therapies (e.g. chemotherapy, targeted therapy, surgery, or radiation) will be included. -Tissue specimens collected within the past 5 yearse will be considered acceptable for study inclusion will include the following
* Collected as part of the evaluation for diagnostic confirmation
* Tissue specimen or extracted DNA (from blood sample) banked in IRB approved tissue repositories and obtained within five years prior to the date of informed consent. -Tissue samples are planned to be collectedfrom previously stored surgical specimens already being stored in pathology lab
* Consent to have germline testing performed in parallel to tumor testingg)Patients willing to receive treatmen

Exclusion Criteria:

* Life expectancy of less than 6months
* Patient unwilling to have germline testing performed on peripheral blood or buccal mucosa
Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients

The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection


Eligibility Criteria:
Inclusion Criteria:

- First or second transplant, cadaveric or living donor

Exclusion Criteria:

* Multi-organ or dual kidney transplants
* Panel reactive antibodies \>50%

Other protocol-defined inclusion/exclusion criteria applied
Assessment of a Personalized Health Care Intervention for Frequent Headache

The research project is a component of a mentored research career enhancement award. The purpose of the award is to help the PI and his collaborators prepare for future research grant opportunities through the Patient Centered Outcomes Research Institute (PCORI). The research project is a feasibility study with the following specific aims; 1) to assess outcomes associated with a personalized health plan for frequent headaches; 2) to identify measurable outcomes that are meaningful to patients with frequent headaches; and 3) to create a patient stakeholder group to inform patient-centered outcomes research for frequent headaches. Specific Aim #1 will be achieved by recruiting and enrolling 40 established patients at the Duke Family Medicine Center who have frequent headaches. The intervention consists of 3 study visits with the PI, 2 clinical consultations with subjects' established primary care provider at the Duke Pickens Family Medicine Center, and participation in 2 focus groups. Personalized health plans might consist of a combination of medical management, lifestyle changes, nutrition counseling, or other therapeutic modalities as appropriate. Data analysis will be descriptive; no formal hypotheses will be tested.


Eligibility Criteria:
Inclusion Criteria:

* patients with chronic headache

Exclusion Criteria:

* patients who do not understand english language
SWOG-9342 Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This clinical trial is studying the effect of chemotherapy on heart function in treating women who have breast cancer with negative axillary lymph nodes and who are undergoing treatment on the SWOG-8897 clinical trial.

OBJECTIVES:

* Compare the frequency of subclinical congestive heart failure by measuring resting MUGA at 5-8 and 10-11 years after randomization in women receiving adjuvant chemotherapy with cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide, doxorubicin, and fluorouracil on protocol SWOG-8897.
* Estimate the frequency of late cardiac effects (congestive heart failure, cardiac ischemic events, and clinical symptoms) in these patients treated with these regimens.
* Monitor prospectively the incidence of annual cardiac events between the fifth and tenth year after randomization of these patients to these regimens.

OUTLINE: This is a multicenter study.

The treating physician completes patient cardiovascular and routine history and physical examination questionnaires at baseline and yearly. Patients undergo resting MUGA scans at 5-8 and 10-11 years after registration on protocol SWOG-8897. The first scan must be performed within 3 months prior to enrollment or within 1 month after registration on the current study, and the second scan must be done in the tenth year of follow-up and within 3 months prior to enrollment or 1 month from the anniversary of registration on the current study.

PROJECTED ACCRUAL: A total of 420 patients will be accrued for this study. After initial accrual is completed, approximately 50 additional patients will be accrued at 10 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Women registered on Arm I, II, III, or IV of protocol SWOG-8897 who have completed at least 1 course of assigned chemotherapy

  * Completion of tamoxifen therapy not required
  * Registration to current study required between 5.25-8 years or 10-11 years after randomization to protocol SWOG-8897
* Patients must be diagnosed disease-free with no prior recurrence after registration on protocol SWOG-8897
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* Pre- and postmenopausal

Performance status:

* Not specified

Life Expectancy:

* At least 5 years

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Pregnant or nursing women not eligible for nuclear medicine (MUGA) portion of study
* Fertile patients must use effective contraception during and for 1 month after MUGA

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* No prior chemotherapy for second primary malignancy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy for second primary malignancy

Surgery:

* Not specified
Reducing Adult Inpatients Anxiety With Virtual Reality Meditation

The purpose of the study is to evaluate if non-invasive, distracting devices (virtual reality) can decrease anxiety and improve affect and satisfaction in adult, hospitalized patients.


Eligibility Criteria:
Inclusion Criteria:

* between age 18-99
* hospitalized at Stanford Health Care
* english-speaking

Exclusion Criteria:

* significant cognitive impairment or inability to consent
* current nausea
* visual problems or currently using corrective glasses that are incompatible with the virtual reality headset
* a history of severe motion sickness
* a history of seizures cause by flashing light
* clinically unstable or require immediate/urgent intervention
Baby Bump Lifestyle Intervention Supplement Study

The overall purpose of this study is to examine how natural supplements can mediate the effects of stress on fetal development during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman presenting to her first obstetrical visit for this pregnancy
* Must be in the first trimester (\<13 weeks)
* 18 years or older
* High-stress levels as measured by the Perceived Stress Level Questionnaire
* Must be a single pregnancy (e.g. not twins, triplets, etc.)

Exclusion Criteria:

* Diabetes (types 1 and 2)
* Diagnosis of gestational diabetes in prior pregnancy
* Hyperemesis gravidarum or severe morning sickness that interferes with supplement intake
* Major medical illnesses including but not limited to: malabsorption syndromes (Celiac's disease, Crohn's, Ulcerative Colitis), Systemic Lupus Erythematosus and other major autoimmune conditions