cyrilzakka/clinical-trials huggingface dataset:
PBA Use for Treatment of ATF6-/- Patients

Some patients with achromatopsia, an inherited disorder characterized by partial or complete loss of color vision, carry mutations in ATF6. ATF6 is a gene that is responsible for coding a protein that acts in response to endoplasmic reticulum (ER) stress. When the ATF6 protein is mutated, retinal function decreases, contributing to color blindness. The study aims to investigate whether an already FDA-approved drug, glycerol phenylbutyrate (PBA), can improve retinal function inpatients with achromatopsia caused by ATF6 mutations. Patients will be instructed to take three doses of PBA per day at equally divided time intervals and rounded up to the nearest 0.5 mL. The total dose of PBA will be 4.5 to 11.2 mL/m2/day (5 to 12.4 g/m2/day) and will not exceed 17.5 mL/day (19 g/day). Their condition will be monitored over the course of a minimum of 3 clinic visits that will consist of a number of retinal function tests, fundus examinations, and imaging procedures. Findings from the study could elucidate the potential for PBA to serve as a treatment for patients with ATF6-mediated a chromatopsia.

ATF6 has been described as an endoplasmic reticulum (ER) stress-regulated transmembrane protein that activates the transcription of molecular chaperones in response to ER stress. Patients harboring mutations in ATF6 present with decreased retinal function and are diagnosed with achromatopsia. The investigator's research group has previously demonstrated that administration of glycerol phenylbutyrate (PBA), a fatty acid compound that facilitates protein folding, can lead to enhanced retinal function in mice that are homozygous for the ATF6 mutation. This study will investigate the effects of PBA administration in two patients who carry ATF6-/- mutations and a diagnosis of achromatopsia. Enrolled subjects will undergo a minimum of 3 clinic visits that consist of a complete ophthalmic examination (best-corrected visual acuity, intraocular pressure, anterior segment examination, slit lamp and binocular fundus examination), a visual functioning questionnaire, color vision tests, contrast sensitivity tests, retinal imaging (optical coherence tomography, short wavelength autofluorescence and near-infrared autofluorescence), a macular sensitivity test (Nidek microperimetry) and full-field electroretinogram (ffERG). A blood draw will be performed at each visit to test for any indications of adverse effects from drug use. Subjects will be instructed to take 3 doses of PBA per day, totaling to a dose of 4.5 to 11.2 mL/m2/day (5 to 12.4 g/m2/day).

Eligibility Criteria:
Inclusion Criteria:

* Patients harboring mutations in ATF6 present with decreased retinal function

Exclusion Criteria:

* Patients who are minors
* Patients who are pregnant
Volatile Markers in Digestive Cancer

The study is aimed to determine the potential of volatile marker testing for identification of gastrointestinal cancers (in particular - colorectal and gastric cancers), the related precancerous lesions in the stomach and colon.

The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.

Patients with established disease (cancer, precancerous lesions) as well as patients investigated for the lesions and having been documented lack of the lesions will be enrolled to the study at clinical sites in Europe (Latvia, Lithuania). In addition, group of persons from general population at average risk for developing the target disease will be also enrolled.

Testing of volatile markers will be conducted by one of two methods: 1) gas chromatography coupled to mass spectroscopy (GS-MS) and 2) nanosensor technology.

Volunteers (including patients with established disease) will be enrolled prior the removal of the target lesion (e.g. surgery for cancer or polypectomy in the case of a polyp).

The study will be conducted by utilizing the experience of institutions in the European Union and Israel.

Eligibility Criteria:
Inclusion Criteria:

* Patients with verifies colorectal cancer (Group 1)
* Patients with verified gastric cancer (Group 5)
* Patients undergoing colonoscopy due to clinical indications (group 2-4)
* Patients undergoing upper endoscopy due to clinical indications (Group 6-8)
* Average-risk population group aged 40-64 at inclusion without alarm symptoms (Group 9)
* Motivation to participate in the study
* Physical status allowing volatile marker sampling and other procedures within the protocol
* Signed consent

Exclusion Criteria:

* Known other active cancer
* Ventilation problems, airway obstruction
* Unwillingness or inability to co-operate
Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation

The purpose of this study is to compare the efficacy of subcutaneous versus oral mu-opioid receptor antagonist therapy in opioid induced constipation that is refractory to other bowel regimens.

Opioid-induced constipation can lead to serious complications, including small bowel obstruction, fecal impaction, and bowel perforation. Not only are the medical complications potentially severe, patient quality of life can also be impacted. Two agents are currently available for opioid-induced constipation - oral and subcutaneous methylnaltrexone and oral naloxegol. Mechanistically, both agents antagonize the peripheral mu-opioid receptor in the gastrointestinal tract to decrease constipation without reversing the systemic analgesic effects of opiates. The literature currently available has evaluated the effectiveness of each agent, not the comparative effectiveness of these agents.

Eligibility Criteria:
Inclusion Criteria:

* Complaint of opioid-induced constipation refractory to other therapy (enemas, laxatives, stool softeners)
* Age≥18y/o
* Not pregnant or lactating (negative urinary pregnancy test)
* No contraindication to Methylnaltrexone or Naloxegol

Exclusion Criteria:

* Age\<18y/o
* Pregnancy or lactation
* Contraindication to Methylnaltrexone or Naloxegol
* Assigned NPO
* Small bowel obstruction
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life

Determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy.

Other endpoints:

* to determine whether high protein ONS influence on the nutritional status
* to determine whether high protein ONS influence on the quality of life
* to determine whether high protein ONS influence on the performance status
* to determine high protein ONS tolerability / ONS intake compliance

Eligibility Criteria:
Inclusion Criteria:

* histological confirmed diagnosis of CRC in clinical stage IV
* successful qualification to chemotherapy
* performance status at least 80% according to Karnofsky scale and \<2 according to WHO/ECOG scale
* cancer-related asymptomatic precachexia diagnosed
* absence of contraindications to oral nutrition and practicable realization of oral nutrition
* absence of severe, decompensated concomitant diseases
* signed informed consent for the participation in the study

Exclusion Criteria:

* diagnosis of a malignant neoplasm in clinical stage I-III
* disqualification from oncologic treatment
* cancer cachexia or cancer anorexia-cachexia syndrome
* poor performance status
* contraindications to oral nutrition or to high protein nutrition
* regular nutritional support at the moment of qualification to the study
* patient incompliance at the moment of qualification to the study
Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome

Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its definition is still evolving. Patients with this syndrome are at increased risk for cardiovascular disease, and at increased risk of mortality from cardiovascular disease.

Metabolic syndrome is strongly associated with obesity, and more specifically with abdominal obesity. Abdominal obesity, comprises two main components: visceral (VAT) and subcutaneous (SAT) adipose tissue depots, with VAT reported as more metabolically active than SAT, and thought to play a major role in the metabolic disturbances associated with obesity and metabolic syndrome.

Non-alcoholic fatty liver disease (NAFLD) is fast becoming the most common liver disease and is associated with obesity, insulin resistance and metabolic syndrome.

Bariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome, NAFLD, and nonalcoholic steatohepatitis (NASH) in obese patients.


Eligibility Criteria:
Inclusion Criteria:

* All subjects must be approved by both insurance and site standard of care to undergo the Roux-en-Y gastric bypass procedure
* Male and Female Candidates for Roux-en-Y Bariatric Surgery
* Must be diagnosed with Metabolic Syndrome; having abdominal obesity and at least 2 other features of the syndrome per IDF (International Diabetes Foundation)
* Obese control group:Subjects should be obese and should not have any other features of metabolic syndrome.

Exclusion Criteria:

* Any subjects with prior bariatric surgery
* No other major surgery within the last 6 months
* Diabetes on treatment with hypoglycemic medication in the previous 6 months

Other exclusions apply
Rate of Return to Sport After Total Knee Prosthesis: Comparison of Three Types of Prostheses

The purpose of the study is the rate of return to sport (regardless of the sport envisaged) after a minimum of 3 years after total knee prosthesis.

This is an ambispective, comparative study of three cohorts, non-randomized, open, monocentric, relating to the return to sport of patients who have benefited from one of the three designs of prostheses under study (medial pivot, medial bearing and cruciate retaining) after total knee prosthesis.

Patients who received a total knee prosthesis with medial pivot, medial bearing and cruciate retaining prosthesis between 2018 and 2020 will be called by the investigator, and the study will be offered to them (D-3 to D0). The investigator will explain the study to the patient, send him the information note electronically and answer all his questions about the study. If the patient agrees to participate after a reflection period, the inclusion (D0) will be documented in the medical file, and the patient will be assessed the same day by telephone using the assessments set up in the study, except for the questionnaires on his functional and physical abilities that will be sent to him electronically. The patient will return his answers to the questionnaires on this same email address or by telephone according to his preference. A secure and unique email address will be created by the principal investigator for the purposes of the study and for use strictly specific to the study, in the investigating center.

Eligibility Criteria:
Inclusion Criteria:

* First total knee prosthesis between 2018 and 2020;
* Conventional alignment technique using the same surgical technique for total knee prosthesis;
* Placement of a medial pivot prosthesis (Evolution®), mobile bearing (SCORE® Amplitude) or traditional cruciate retaining prosthesis (Stryker® Triathlon);
* Affiliation to a social security scheme;
* Patient having been informed and having given his oral non-objection

Exclusion Criteria:

* Bilateral total knee prosthesis;
* Medical history of revision of Total Knee Prosthesis;
* Articulation malformation of the lower limbs;
* Having undergone revision surgery;
* Inability to understand information related to the study for linguistic, psychological, cognitive reasons;
* Patient under legal protection, or deprived of liberty by judicial or administrative decision.
Crowdsourcing to Promote HBV and HCV Testing in China

This is an online randomized controlled trial (RCT) comparing men who have sex with men (MSM) exposed to a crowdsourced intervention to MSM who did not receive the intervention to determine the effect on Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) testing. Participants will be randomly assigned in a 1:1 ratio to intervention or control using a computer-based allocation system. Participants will be assessed for primary and secondary outcomes four weeks after randomization.

700 MSM will be recruited through social media operated by gay organizations in China. Eligible participants will be born biologically male, age 16 years or older, report previous anal sex with another man, and reside in China. Men self-reporting previous HBV vaccination, HBV testing, or HCV testing will be excluded. After completing a baseline online survey, participants will be randomly assigned to intervention or control arms with a 1:1 allocation ratio. The intervention will include two components: (1) a multimedia component will deliver two videos and two images promoting HBV and HCV testing developed through a crowdsourcing contest in China. (2) A participatory component will invite men to submit suggestions for how to improve crowdsourced videos and images. The control arm will not view any images or videos and will not be invited to submit suggestions. All participants will be offered reimbursement for HBV and HCV testing costs. The primary outcome is HBV and HCV test uptake confirmed through electronic submission of test report photos within four weeks of enrollment. Secondary outcomes include self-reported HBV and HCV test uptake, HBV vaccination uptake, and change in stigma toward people living with HBV measured through a follow-up survey after four weeks. Men with primary and secondary outcomes will be calculated using intention to treat and as-exposed analyses and compared using two-sided 95% confidence intervals.

Eligibility Criteria:
Inclusion Criteria:

* 16 years of age or older
* male
* report having had anal sex with another man at least once in the past
* currently reside in China
* willing to provide working mobile phone number and WeChat account

Exclusion Criteria:

* previous HBV vaccination
* previous HBV testing
* previous HCV testing
Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma

This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.


Eligibility Criteria:
Inclusion criteria:

* Performance Status Eastern Cooperative Oncology Group: 0 or 1.
* Adequate organ function.

Exclusion criteria:

* Pregnancy or lactation.
* Prior treatment with any form of IL-2.
* Organ transplant. Other protocol-defined inclusion/exclusion criteria may apply
Hepatitis B Virus Reactivation After Withdrawal of Preemptive Antiviral Therapy in Hematologic Malignancy

Previous studies dealt with patients who maintained antiviral drugs for 2 \~ 6 months after final chemotherapy and they revealed that many of the patients who stopped preemptive antiviral drug within 6 months experienced viral reactivation. Based on the study results, guidelines recommend that preemptive antiviral therapy should be maintained for at least 6 months. Nevertheless, many clinicians apply the preemptive antiviral drugs for 1\~2 years or longer after final chemotherapy without definite evidences, and this practice increases the medical expenditure a lot. Therefore, the investigators are going to find out the proper and safe duration of preemptive antiviral therapy which can be a good reference in the future practice.

HBV reactivation in cancer patients is important not only for directly affecting severe hepatic failure but also for delaying of the further cancer treatments which may cause reduction of overall survival. Thus the guidelines according to the previous studies and other follow-up of randomized studies revealed that patients with positive HbsAg should be administered with preemptive antiviral therapy at least 6 month or more.

However, ideal duration for preemptive antiviral therapy to suppress viral reactivation and withdrawal hepatitis is not clearly identified at present time. It is because previous data just dealt with the efficiency of preemptive antiviral therapy, but most of them did not analyze the outcomes after withdrawal of antiviral therapy. Frequent late-onset reactivation hepatitis in association with preemptive antiviral therapy is mainly due to drug-resistance or post-withdrawal manifestation. Drug-resistance was mainly associated with lamivudine which is now substituted by entecavir or tenofovir which produce lower incidence of resistance (\< 1.2% at 6 years). Therefore, the only issue at present is withdrawal hepatitis which may be due to early cessation of the antiviral drug.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* ECOG performance status 0, 1, 2
* Hodgkin's or Non-Hodgkins lymphomas according to the WHO 2008 classification
* Patients who received standard cytotoxic chemotherapies
* Patients who finished chemotherapy (duration not exceeded 6 months) or who will finish the planned chemotherapy
* Patients who achieved at least partial response and do not need further chemotherapy
* HBsAg (+) patients who received preemptive antiviral therapies

Exclusion Criteria:

* Anti-HCV Ab(+), HIV(+), or autoimmune hepatitis
* Complications due to uncompensated liver cirrhosis
* Child pugh score : 10 points or more
* Hepatocellular carcinoma
* Patients who finish the lymphoma treatments with only radiotherapy
Self-management of Anticoagulation Treatment

The aim of the study was to compare self-management of anticoagulant treatment with conventional anticoagulant treatment in Norway.

Patients (n=132) on anticoagulant treatment with warfarin participated in a 21 weeks training program where they learned how to analyse International Normalised Ratio (INR) using the point-of-care instrument CoaguChek®XS and dose warfarin. The patients had to display their skills through a test before considered self-managing. They continued to measure INR weekly for two years. All INR values during the training program and self-control period were collected. In addition, the patients were told to notify if they had any complications during this period. INR values and complications two years before enrolment was collected from INR cards and/or their general practioner. The participant filled in a quality of life-questioner at enrolment and after two years of self-management.

Eligibility Criteria:
Inclusion Criteria:

* On life-long oral anticoagulation therapy
* Judged to be qualified for patient self-management anticoagulation treatment by their GP
* Motivated to follow the training program

Exclusion Criteria:

* Drug abuse
* Liver disease
Dose-Range Finding Study for MK0893 (0893-008)

A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).


Eligibility Criteria:
Inclusion Criteria:

* Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

Exclusion Criteria:

* Patients have a history of Type 1 Diabetes Mellitus
* Patients taking insulin or thiazolidinedione (TZD, a peroxisome proliferator-activated receptor \[PPAR\]-gamma agonist)
* Patients who have a contraindication to metformin
Iscar for Supplemental Care in Stage IV Lung Cancer

The purpose of this study it to determine whether supplemental treatment with Iscar improves immune function and quality of life among Stage IV non-small cell lung carcinoma patients receiving conventional chemotherapy. Iscar is an herbal medicine made from the total plant extract of mistletoe. this preparation is already in use in Europe and its use in the US is likely to increase as cancer patients continue to seek alternative therapies.

See Brief Summary

Eligibility Criteria:
Inclusion Criteria:

* Stage IV NSCLC patients who receive standard chemotherapy

Exclusion criteria:

* Known allergy to Viscum Album L.
* Concomitant use of other mistletoe products
* Concomitant use of mushroom glucan and proteoglycan extracts
* Concomitant use of thymus extract products
* Inability to self-report quality of life utilizing assessment tools
* Ongoing steroid or ACTH therapy
* Co-morbid immunocompromised state
* Pregnancy
* Participation in other clinical trials
Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

The purpose of this study is to compare of Efficacy and Safety Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH).


Eligibility Criteria:
Inclusion Criteria:

* 50 yrs or greater
* International prostatic symptom score \>= 12
* Bladder outlet obstruction confirmed by pressure-flow study (BOOI \> 20)
* Able to give fully informed consent

Exclusion Criteria:

* Patients with urologic malignancies such as prostate cancer and bladder cancer
* Patients underwent urethral, prostate surgery
* Patients with urethral stricture or bladder diverticulum or bladder neck contracture
* Patients with histories of bacterial prostatitis within 1 year
* seems not to be appropriate to this study by the decision of investigators because of any other reasons
Atrial Fibrillation and Cancer: a Nationwide French Cohort Study

Atrial fibrillation (AF) is a common complication associated with cancer but the risk of AF according to the cancer localization and status as well as the risk of thromboembolisms, bleedings and mortality are poorly known.

The objective of this study is to use a very large French nationwide cohort to adress thèses questions.


Eligibility Criteria:
Inclusion Criteria:

* adult hospitalized patients
* with an ICD-10 code discharge from january 2010 to december 2019 in the French national hospital discharge database (PMSI Programme de Médicalisation des Systèmes d'Information)

Exclusion Criteria:

* children