cyrilzakka/clinical-trials huggingface dataset:
Safety Evaluation of β-arbutin in Healthy Human Subjects

The purpose of this study is to determine the safety of synthetic beta-arbutin, a dietary supplement that aids in the prevention and treatment of calcium oxalate kidney stones, when administered to healthy human subjects.

The objective and purpose of this Phase I study is to investigate the safety of synthetic beta-arbutin, administered to healthy human subjects for: i) 12 weeks, at a dose of 150 mg/day, and ii) 4 weeks, at a dose of 400mg/day. Safety will be determined by assessing adverse event rates between treatment groups and mean changes relative to baseline in serum biochemical, hematological and urinary markers.

Eligibility Criteria:
Inclusion Criteria:

* Adults, aged 18-65 years
* includes non-pregnant, non-breastfeeding women on adequate birth control
* acceptable effective contraceptive methods for participants with child-bearing potential include: barrier methods (condoms), total abstinence, hormonal birth control methods (oral, injectable, transdermal, or intra-vaginal), intrauterine devices, and confirmed successful vasectomy of partner;
* Body Mass Index (BMI) of 18.5-35 kg/m2;
* Generally healthy (absence of active clinical disease as determined by serum biochemical, hematological, and urinary parameter tests as well as detailed medical history and blood pressure measurements) as assessed by the PI/QI;
* Males and females of childbearing potential willing to use appropriate effective contraception for the duration of the study;
* Agrees to maintain current diet and exercise routine during the study;
* Ability to provide written informed consent; and
* Willing to comply with all study requirements and provide urine and blood specimens over the 12-week study period..

Exclusion Criteria:

* Pregnant or breastfeeding women;
* History of renal dysfunction;
* History of macular degeneration as assessed by the PI/QI;
* History of liver disease as assessed by the PI/QI;
* Type I or Type II diabetes;
* Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the PI/QI History of renal dysfunction, as assessed by the PI/QI;
* Cancer being actively treated with systemic therapy (i.e. chemotherapy, immune therapy);
* Self-reported HIV-, Hepatitis B-, and/or C-positive diagnosis;
* High alcohol intake (average of \> 2 standard drinks per day);
* Heavy smokers (average of \>10 cigarettes per day);
* Use of cannabinoid products within 30 days of enrollment;
* Any history of major surgery (i.e. inter-abdominal, inter-thoracic, inter-cranial) within the last six months, or surgery planned during the course of the study;
* Known hypersensitivity to arbutin;
* Allergy to all ingredients (including non-medicinal ingredients) in investigational products and placebo product
* Self-reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation; and
* Clinically significant abnormal laboratory results at screening as assessed by the PI/QI
Analysis of Intestinal Defensin Expression in Acute GVHD

This study has the aim to analyze intestinal expression of endogenous antimicrobial peptides in patients with acute GVHD. The expression will be compared to intestinal expression of defensins in patients with colitis and patients without intestinal inflammation.

Acute graft-versus-host disease (GVHD) is a major cause of morbidity and mortality in patients undergoing allogeneic hematopoietic cell transplantation (allo-HCT). Acute GVHD is characterized by complex deficiencies of the mucosal antimicrobial barrier and intestinal dysbiosis, which contribute to disease pathogenesis. Defensins are endogenous epithelial cell-derived antimicrobial peptides, which can protect epithelial barrier integrity, shape the intestinal microbiota composition and contribute to host immunoregulation. Deregulated expression of defensins has been reported in patients with colitis, including Chron's Disease and ulcerative colitis.

In this study, the investigators aim to analyze the expression of defensins in the intestine of patients with acute GVHD to study whether it is deregulated. The results will be valuable to study the role of defensins during acute GVHD pathogenesis or as potential biomarkers for disease activity.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* diagnostic endoscopy was performed
* diagnosis results available
* written informed consent
* ability to understand the nature of the study and the study related procedures and to comply with them

Exclusion Criteria:

* age \< 18 years
* gastrointestinal cancer
* lack of informed consent
A Study to Evaluate Tislelizumab Combined With Sitravatinib as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection

This is an open label, multi-center, single arm study to evaluate the efficacy and safety of tislelizumab combined with sitravatinib as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.

Hepatocellular carcinoma (HCC) is a malignant tumor with high morbidity and mortality. Surgical resection is the most important radical treatment. However, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection. How to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring.

Until now there is no standard postoperative adjuvant therapy. Various adjuvant treatment methods including immunotherapy, targeted therapy, TACE are being studied. This study is to explore the efficacy and safety of tislelizumab combined with sitravatinib as adjuvant therapy in HCC patients who are at high risk of recurrence after curative resection.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with a histopathological or cytologically diagnosis of HCC
2. Subjects who have undergone a curative resection
3. High risk for HCC recurrence as protocol defined
4. No previous systematic treatment and locoregional therapy for HCC
5. Child-Pugh Score, Class A
6. ECOG performance status 0 or 1
7. Full recovery from surgical resection
8. Adequate organ function
9. Absence of major macrovascular invasion
10. No extrahepatic spread
11. Life expectancy of at least 6 months

Exclusion Criteria:

1. Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
2. Evidence of residual, recurrent, or metastatic disease
3. Known history of serious allergy to any component of tislelizumab or sitravatinib preparations
4. History of hepatic encephalopathy
5. Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein
6. Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment
7. Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
8. Any active malignancy within 2 years prior to the start of treatment
9. Active or history of autoimmune disease
10. Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
11. Pregnant or lactating women
An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma

This open-label, single-arm, multicenter study will assess the safety and efficacy of Zelboraf (vemurafenib) in patients with Braf V600 mutation positive metastatic melanoma. Patients will receive Zelboraf 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.


Eligibility Criteria:
Inclusion Criteria:

* Adults patients \>= 18 years of age
* Patients with histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with documented BRAF V600 mutation determined by the cobas® BRAF V600 Mutation Test prior to administration of vemurafenib. Unresectable stage IIIC disease must have confirmation from a surgical oncologist
* Patients with either measurable or non-measurable disease (RECIST Version 1.1)
* Patients may or may not have received prior systemic therapy for metastatic melanoma
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma
* Adequate hematological, renal, and liver function
* Negative serum pregnancy test at screening
* Fertile men and women must use an effective form of contraception during the study and for at least 6 months after completion of the study

Exclusion Criteria:

* Evidence of symptomatic CNS lesions as determined by the investigator, use of steroid or anti-seizure medication for treatment of brain metastases prior to the first administration of vemurafenib
* Patients with previous malignancies (other than melanoma) within the past 2 years except patients with treated and controlled basal or squamous cell carcinoma (SCC) of the skin or carcinoma in-situ of the cervix.
* Concurrent administration of any anti-cancer therapies (e.g. chemotherapy, other targeted therapy, experimental drug, etc.) other than those administered in this study
* Known hypersensitivity to vemurafenib or another BRAF inhibitor
* Pregnant or lactating women
* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
* Any of the following within the 6 months prior to the first vemurafenib administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischaemic attack, pulmonary embolism, hypertension not adequately controlled by current medications.
Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Headache Disability Questionnaire

The purpose of this study was to investigate cultural adaptation, reliability and validity of the Turkish version of the Headache Disability Questionnaire (HDQ).

When the outcome criteria for the physiotherapy of headache are considered in clinical studies and practice, parameters such as headache frequency, duration and severity are frequently used. Physiotherapists treat musculoskeletal dysfunction in various types of headache, including migraine, tension headache, and cervicogenic headache. The Headache Disability Questionnaire (HDQ), which was developed to measure the quality of life of a general population receiving physiotherapy and experiencing headache, evaluates the pain intensity, daily life activities, disruptions in work or school life, and the influence of the recreational activities of individuals. HDQ consists of 9 items and each item is rated between 0 and 10. Increasing the score indicates the seriousness of the impact. The study is planned with 45 individuals with gluteal tendinopathy. After questioning the sociodemographic characteristics of the individuals, the patients will be asked to fill in HDQ, Migraine Disability Assessment Questionnaire, Headache Impact Test-6 and Short Form-36.Test-retest will be re-applied to those of the same individuals who can be reached after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with any type of headache,
* Have a chronic headache.

Exclusion Criteria:

* Having a cognitive and neurological disorder.
A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection

To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) plus Lenvatinib for patients with hepatocellular carcinoma and portal vein tumor thrombus (PVTT ) after hepatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a histopathological diagnosis of HCC
* Undergone a curative resection
* Pathologically confirmed HCC with portal vein tumor thrombus (PVTT)
* Aged 18-75 years
* No previous systematic treatment and locoregional therapy for HCC prior to randomization
* No extrahepatic spread
* Full recovery from Curative resection within 4 weeks prior to randomization
* Child-Pugh: Grade A or B(7)
* ECOG-PS score: 0 or 1
* Adequate organ function

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC
* Any preoperative treatment for HCC including local and systemic therapy
* Have received more than 1 cycle of adjuvant TACE following surgical resection
* Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
* Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
* Active or history of autoimmune disease
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Inability or refusal to comply with the treatment and monitoring
Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.

The purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the lumbar spine. The observed success rate at 24 months will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.

This is a single arm multi-center study to determine the clinical success of the DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two adjacent levels of degenerative disc disease of the lumbar spine (L2 - S1).

Study Success is as a compound endpoint requiring:

* Radiographic Fusion,
* Improvement in Pain/Function,
* Maintenance/Improvement in Neurologic Status, and
* Freedom from Secondary Surgical Intervention.
* The rate of Adverse Events must be no worse than in the control group as well.

Secondary Endpoints Include:

* Adverse Events
* SF-36 Health Related Quality of Life
* Disc Space Height
* Work Status

Comparison:

Results will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.

Eligibility Criteria:
Inclusion Criteria:

* Persistent back and/or leg pain refractory to 6 months of non-surgical therapy
* Radiographic evidence of significant disc degeneration at one or two of the adjacent lumbar levels L2-S1.

Exclusion Criteria:

* Abnormality at more than two levels,
* Prior fusion surgery of the lumbar spine; prior discectomies or IDET allowed,
* Infection in the disc or spine, past or present,
* Active infection at time of surgery,
* Tumor in the spine,
* Significant osteoporosis or metabolic bone disease,
* Greater than Grade I spondylolisthesis or significant bony defect in the lumbar spine,
* Pregnant or lactating, or wishes to become pregnant within duration of study,
Pilot of 18F-DCFPyL-PSMA PET in MCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan

The purpose of this research study is to see how well an imaging test, called 18FDCFPyL prostate specific membrane antigen (PSMA) positron emission tomography (PET), can show the extent of prostate cancer when comparing to 68Ga-PSMA-11 PET/CT (another type of diagnostic scan for prostate cancer).

This is a one-arm single-stage prospective pilot study to determine how 18F-DCFPyL PSMA-PET/CT can be used as a diagnostic test before treatment with 177Lu-vipivotide tetraxetan, which is an approved therapy for advanced prostate cancer.

The U.S. Food and Drug Administration (FDA) has approved 18F-DCFPyL as a diagnostic agent (radiotracer) option for prostate cancer, though it is not specifically approved for participants who are due to receive 177Lu-vipivotide tetraxetan therapy.

This research study involves a single PET scan using the imaging agent 18F-DCFPyL and the collection of information from medical records.

Participation in this research study is expected to last about 12 months.

It is expected that about 30 people will take part in this research study. Progenics Pharmaceuticals, Inc. is funding this research study by providing funding and the imaging agent, 18F-DCFPyL.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically or cytologically confirmed prostate cancer.
* Age ≥18 years.
* Participants must be planned for standard-of-care 177Lu-Vipivotide Tetraxetan therapy after the 18F-DCFPyL PSMA-PET.

  -≥1 PSMA-avid lesion on 68Ga-PSMA-11 PSMA-PET performed within 120 days of study entry (to meet eligibility for 177Lu-Vipivotide Tetraxetan therapy).
* Ability and willingness to comply with the study procedures.
* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agent are eligible for this trial.
* The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reason and because radiopharmaceutical agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 24 hours after the 18F-DCFPyL PSMA-PET scan.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Contraindications to PET/CT, including severe claustrophobia.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL
* Any past or current condition that, in the opinion of the study investigators, would confound the results of the study or would pose additional risk or burden to the patient by their participation in the study.
Manual Therapy and Augmented Exercise for Neck Pain

Manual therapy and exercise have shown to be beneficial for people with neck pain, however it is not clear how outcomes following a general exercise program compare to specific exercises intended to augment a specific manual/hands-on intervention. This study will compare outcomes following manual therapy and a specific exercise program with manual therapy and a general exercise program.

The purpose of this study is to determine if specific neck exercises intended to augment specific manual therapy treatments result in better outcomes than standard neck exercises in people with neck pain. Clinical tests and measurements as well as patient questionnaires will be completed and compared between groups.

A secondary purpose is to determine if self report of activity is correlated with functional improvements. We hypothesize that a specifically applied home exercise that augments the effects of the manual therapy intervention will lead to improvements in outcomes in patients with neck pain. We hypothesize that higher reports of self activity will be correlated with improvements in outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with complaint of neck pain, neck motion limitations, pain at end-range neck ROM, limited cervical/cervical and thoracic joint mobility, neck pain with manual segmental examination

Exclusion Criteria:

* The presence of any red flags (i.e. tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, signs and symptoms of vertebrobasilar insufficiency, etc.), use of blood thinners, whiplash injury in the past 6 weeks, evidence of central nervous system involvement (such as hyperreflexia, sensory disturbances in the hands, unsteadiness during walking, etc.), history of spinal surgery, workers compensation or pending legal action regarding their neck pain, insufficient English language skills to complete questionnaires, unable to comply with schedule
Serious Game to Teach Opioid Overdose Response

This study evaluates the efficacy of a serious game to teach students how to recognize and respond to opioid overdose

This study uses an interactive realistic film depicting an opioid overdose to teach high school/middle school students how to recognize and respond to opioid overdose. The film features a person who finds their friend unresponsive, with evidence of opioid use. The unresponsive friend demonstrates signs of opioid overdose. The hero must recognize opioid overdose, administer naloxone (opioid antedote) and perform CPR. The film is made interactive by the narrator pausing the action of the film, and asking learners to answer questions/make choices.

Efficacy is tested on the day of training, and 2-4 months later. Efficacy is measured by student ability to correctly administer naloxone to a manikin, perform CPR, and answer knowledge questions about opioid overdose. Other studied metrics include student engagement/enjoyment, attitudes/biases, and emotions created by the training. These will be tested through validated questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Student at participating school, enrolled in Health or Science Class

Exclusion Criteria:

* None
CMT-07-08: The PROstate Bed Evaluation Study

This is an observational study to collect placement and tracking data for patients who have the Calypso transponders implanted into the peri-prostatic tissue.

Use of Real-time tracking using Calypso Electromagnetic Beacons in the prostatic bed of patients receiving radiotherapy following radical prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with recurrence of prostate cancer following radical prostatectomy for prostate adenocarcinoma
2. Patients with initially undetectable PSA following prostatectomy for prostate adenocarcinoma with subsequent PSA relapse
3. Patients being planned for radiation therapy
4. Patient is being planned for implant with Calypso Transponders in the prostate bed
5. No evidence of distant metastases
6. Age ≥ 18 years
7. Informed consent

Exclusion Criteria:

1. The patient has received other investigational therapy in the last 60 days
2. The patient has previously been implanted with permanent beacon transponders
3. The patient has a prosthetic implant in the pelvic region that contain metal or conductive materials
4. The patient has any other medical or other condition that would, in the investigator's opinion, make them a poor candidate for the study