cyrilzakka/clinical-trials huggingface dataset:
GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's Disease.

This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease


Eligibility Criteria:
Key Inclusion Criteria

-Huntington's disease (HD) gene expansion mutation carrier status with a CAP score of 400-500 inclusive

Either:

* Prodromal HD (defined as DCL 2 to 3, Independence Scale (IS) ⩾70, and ⩾TFC8); or
* Early manifest HD (defined as DCL 4, Independence Scale (IS) ⩾70, and ⩾TFC8);
* Total body weight \> 40 kg and a body mass index within the range of 18-32 kg/m2
* Study Companion

Key Exclusion Criteria

* Current or previous use of an ASO (including small interfering RNA) or any HTT lowering therapy (including tominersen)
* Anti-platelet or anticoagulant therapy within 14 days prior to screening or anticipated use during the study, including, but not limited to, aspirin (unless \</= 81 mg/day), clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban, apixaban, and heparin
* History of gene therapy, cell transplantation, or brain surgery
* Hydrocephalus
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of study drug
* History of attempted suicide or suicidal ideation with plan (i.e., active suicidal ideation) that required hospital visit and/or change in level of care within 12 months prior to screening
Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery

The purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with traditional physical-occupational therapy (OT) will improve motor function in patients with chronic stroke. The aim is to determine the effect of applying real (anodal and/or cathodal) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on both hemispheres - in a dual configuration - to improve motor function in chronic stroke patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS is applied to the brain's motor region during motor learning. The effects after a single session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. Patients enrolled in this trial will be randomized to receive either real tDCS or sham tDCS in combination with PT-OT once a day for 5 days. Assessments will be done about 3 days and 7 days after the end of the experimental treatment by investigators who are blinded to the intervention. Patients are also blinded as to whether they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor regions in combination with PT-OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with PT-OT.


Eligibility Criteria:
Inclusion Criteria:

* First time clinical ischemic stroke or cerebrovascular accident
* At least 5 months out from first ischemic stroke prior to study enrollment

Exclusion Criteria:

* More than 1 stroke (older strokes)
* Significant pre-stroke disability
* A terminal medical illness or disorder with survival of less than 1 year
* Co-existent major neurological or psychiatric diseases (e.g., epilepsy)
* Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents
* Active participation in other stroke recovery trials testing interventions
Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)

The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg\^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.


Eligibility Criteria:
Inclusion criteria:

* American Society of Anesthesiologists (ASA) Class 1-3 participants who are scheduled to undergo an elective surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium.

Exclusion criteria:

* Participants with neuromuscular disorders, significant renal dysfunction, malignant hyperthermia, allergy to medications used in general anesthesia and in whom difficult intubation is expected.
* Participants taking medications known to interfere with neuromuscular blocking agents.
* Participants who are of child-bearing potential, pregnant, and breast feeding
Hepatitis C Infection in World Trade Center Responders

This study provides Hepatitis C virus screening to the members of the World Trade Center Health Program followed at the Icahn School of Medicine at Mount Sinai born during 1945-1965, and linkage to care for those found infected. The study will also determine if exposure to human remains, blood and/or bodily fluids during the World Trade Center Health Program activities are associated with Hepatitis C virus infection. These findings would be relevant to the larger United States population, especially to persons born during 1945-1965 who are at high risk of Hepatitis C virus infection.

The purpose of the project is to determine if the World Trade Center Health Program cohort is at an increased risk of Hepatitis C virus infection, determine if human exposure to human remains, blood and/or body fluids during the World Trade Center recovery activities is associated with increased risk of Hepatitis C virus infection, and to determine if referral to a co-located site for Hepatitis C virus care is associated with improved linkage to Hepatitis C virus care in the members of the World Trade Center Health Program born during 1945 through 1965.

Eligibility Criteria:
Inclusion Criteria:

* Member of the World Trade Center Health Program at the Icahn School of Medicine at Mount Sinai
* Born during 1945-1965

Exclusion Criteria:

* None
Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)

This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 \[del(5q)\].

The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.


Eligibility Criteria:
Inclusion Criteria:

* Are ≥ 18 years old at the time of signing the Informed consent form (ICF)
* Are transfusion dependent or have an history of transfusion dependence; for the purpose of the current Myelodysplastic syndromes (MDS) Post-authorization safety study (PASS), transfusion-dependence is defined as requiring ≥2 RBC units over an 8 week period prior to the date of signature on the ICF (due to MDS-related causes and not because of hemorrhage, trauma, or other acute cause)
* Are on active treatment with lenalidomide (Lenalidomide Cohort) or have never been exposed to lenalidomide at the time of signing the ICF (Background Cohort)
* Have confirmed diagnosis of IPSS low or intermediate-1-risk MDS with isolated del (5q) (with morphological and cytogenetic information) diagnosed on 15 June 2007 (date of Revlimid first approved in Europe) or later

Exclusion Criteria:

* Refuse to participate in the Myelodysplastic syndromes (MDS) Post-authorization safety study (PASS),
* Are currently participating in an interventional therapeutic clinical trial for MDS (except for erythropoiesis-stimulating agents \[ESAs\] and granulocyte colonystimulating growth factors)
* Receive any investigational agent the time of signing the ICF
* Have previously been treated with lenalidomide and are no longer on active treatment with lenalidomide at the time of signing the ICF
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults

The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 \[ABT-450/r/ABT-267; ABT-267 also known as ombitasvir\] and ABT-333 \[also known as dasabuvir\]) plus ribavirin (RBV) compared with telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).

A randomized, open-label, parallel-arm, multicenter study to evaluate the safety and antiviral activity of the 3-DAA regimen (ABT-450/ritonavir/ABT-267 \[ABT-450/r/ABT-267\] and ABT-333) plus ribavirin (3-DAA/RBV) compared with the combination of telaprevir (TPV) with RBV and pegIFN (TPV/RBV) in noncirrhotic participants with chronic hepatitis C virus genotype 1 (HCV GT1) infection who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).

Participants were randomized in a 2:1 ratio to receive 3-DAA/RBV (ABT-450/r/ABT-267 and ABT-333 plus RBV for 12 weeks) or TPV/RBV (TPV co-administered with pegIFN and RBV for 12 weeks, followed by followed by pegIFN and RBV for either 12 or 36 weeks, per local prescribing information).

Eligibility Criteria:
Inclusion Criteria:

* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
* Chronic hepatitis C infection (positive for anti-HCV antibody or HCV RNA at least 6 months before screening and at the time of screening; or positive for anti-HCV antibody or HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection)
* Screening laboratory result indicating HCV genotype 1 infection (HCV GT1)
* Participant must have documentation of adherence to a prior pegIFN/RBV combination therapy and meet one of the protocol definitions for treatment failure: null responder, partial responder, relapser
* No evidence of liver cirrhosis

Exclusion Criteria:

* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
* Positive screen for drugs or alcohol
* Significant sensitivity to any drug
* Use of contraindicated medications within 2 weeks of dosing
* Abnormal laboratory tests
Analgesia in Minimally Invasive Direct Coronary Artery Bypass Grafting: Programmed Intermittent Bolus Infusions of Erector Spinae Plane Block Versus Paravertebral Block

Paravertebral block (PVB) has been regarded as effective regimen for pain control after cardiac surgery. As a novel analgesia technique, erector spinae plane block (ESPB) has been reported to provide effective analgesia after thoracic and cardiac surgery. We hypothesized that the ESPB is non-inferior to PVB in treating pain in minimally invasive direct coronary artery bypass surgery.

Minimally invasive direct coronary artery bypass grafting has recently gained with popularity in treatment of coronary artery disease. Compared with conventional approach, it has advantages of less trauma and rapid recovery, but postoperative pain is severe, which may increase the risk of cardiopulmonary complications and cause chronic pain. Therefore, perioperative analgesia is crucial in minimally invasive direct coronary artery bypass grafting.

Paravertebral block (PVB) has been regarded as effective regimen for pain control after cardiac surgery. As a novel analgesia technique, erector spinae plane block (ESPB) has been reported to provide effective analgesia after thoracic and cardiac surgery. We hypothesized that the ESPB is non-inferior to PVB in treating pain in minimally invasive direct coronary artery bypass surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective minimally invasive direct coronary artery bypass grafting

Exclusion Criteria:

1. Contraindications to regional anesthesia (coagulopathy, infection of the skin at the site of needle puncture area, et al)
2. Morbid obesity (body mass index \> 35 kg/m2)
3. Allergy to any of the study drugs
4. Chronic opioid use or history of opioid abuse.
5. Inability to understand pain score
Consensus in Surgical Community for Asymptomatic Abdominal Wall and Incisional Hernias

Hernia pathology is one of the leading causes of surgery worldwide. For asymptomatic patients, surgery remains questionable. Although there are new European recommendations, the practice of digestive surgeons regarding the management of asymptomatic hernias is unknown. The objective of this study was to evaluate the practices of a large population of digestive surgeons with asymptomatic hernia.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* No
Postprandial Inflammatory Response in Healthy Men: Effect of Dietary Fat Source, Obesity and Age

The nature of dietary lipids, age and perivisceral adiposity could alter the postprandial inflammatory response. It is supposed that there is a relationship between the postprandial inflammatory response and the repartition of fat and lean mass, which could partially explain the muscle mass loss with age.

The aim of this study is to compare the inflammatory response of a normal meal or high fat meal (from different fatty acids sources) between young lean and young obese and aged lean and aged obese men.

32 healthy volunteers will be separated into four groups: 8 young lean men, 8 young obese men, 8 aged lean men and 8 aged obese men. They will come to the center four times after inclusion, with 2 to 4 weeks wash out each time. At the first visit they will undergo different test to evaluate their body composition, glucose tolerance, resting energy expenditure, and muscular strength. At the other three visits, people will undergo a kinetic blood sampling, urine and biopsies of adipose tissue over a period of 8h after ingestion of a test meal. The different meals tested (Oleic acid vs palmitic acid vs no lipid) will be given in a random way over the three visits. Before each of these three visits, a controlled diet will be established. At the last visit body composition and muscular strength will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Subject giving his written informed consent
* Male from 20 to 35 years old and more than 60
* Affiliated to the French National Health Insurance
* Body mass index (BMI) ≤ 25kg/m² and waist circumference ≤94cm ; or BMI ≥ 28kg/m² and waist circumference ≥ 102cm.
* Complete blood count (CBC)-platelet, normal liver function and normal coagulation.
* Serology of Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) negative
* normal Thyroid Stimulating Hormone(TSH)

Exclusion Criteria:

* Previous medical and/or surgery judged by the investigator as incompatible with this study
* Glaucoma
* C-reactive protein \> 10 mg/l
* people over 120 kg
* People with triglyceridemia \> 3 g/L or with familial hypercholesterolemia
* Fasting glycemia \> 1,26 g/l, abnormal Oral Glucose Tolerance Test
* Dietary habits judged by the dietitian as incompatible with the study aim
* Vegetarians
* Nutritional allergies or xylocaïn allergy
* People with eating disorders
* Heavy consumer of alcohol or cigarette
* Practising intensive physical exercise
* People with medication that could interfere with the measured parameters: beta-blockers, statins, anticoagulants, antiplatelet agents, corticosteroids for more than 8 days.
* Depression or psychiatric treatment
* Being under someone's supervision
* Refusal to be registered on the National Volunteers Data file or refusal to sign the consent form
* Being in exclusion on the National Volunteers Data file
* Blood donation into the last two months preceding the study
Study of the Predictive and Prognostic Role of Pharmacogenetic and Radiogenic Variants on the Response to Neoadjuvant Chemoradiation Therapy in Patients With Locally Advanced Rectal Cancer

In locally advanced rectal cancer the pathological complete response (pCR) to neoadjuvant chemoradiation therapy (nCRT) is associated with a favourable long-term prognosis. The identification of markers predictive of response to therapy would therefore optimise treatment by allowing personalised therapy. It has been shown that the genetic profile of the patient could influence the activation of the immune system in combination with chemoradiation therapy in targeting tumour cells. In addition, genetic features of molecular pathways correlated with response to chemoradiotherapy, may in turn affect the probability of a good response to treatment in these patients, but also the occurrence of adverse events. The main objective of the study is to define the role of genetic markers related to immune system activation and other molecular pathways in predicting the complete pathological response to preoperative chemoradiation therapy in patients with locally advanced rectal cancer.


Eligibility Criteria:
Eligibility criteria:

1. histologically confirmed diagnosis of primary resectable LARC;
2. confirmed absence of distant metastases;
3. ≥18 years old;
4. stage of disease T3-T4 and N0-N2;
5. performance status (World Health Organisation) 0-2;
6. normal bone marrow, kidney and liver function;

Exclusion Criteria:

1. evidence of secondary tumour
2. inadequate liver function (bilirubin \>1.5 times the normal range, ALT and AST \>2 times the normal range);
3. inadequate renal function (creatinine \>1.5 times the upper limit of normal range);
4. Major concomitant systemic diseases that contraindicate surgery;
5. significant cardiovascular disease (heart failure, acute myocardial infarction within the last year, active angina, cardiac arrhythmia to be treated, uncontrolled hypertension)
6. systemic disease contraindicating radiotherapy
Derivation of An In-Hospital Cardiac Arrest Prediction Model for Patients in Intensive Care Unit

Current studies have shown that hospitalized ICU patients have a high risk of IHCA, with an incidence of about 0.6-7.8%. Early prediction of the occurrence of IHCA in severe patients can provide early intervention, prevent the deterioration of the disease, and reduce the incidence of IHCA. Therefore, researchers wanted to verify the efficacy of MEWS, NEWS, and CART scores in predicting IHCA in ICU inpatients, and to establish an early-warning scoring model that could effectively predict the risk of IHCA occurrence in ICU inpatients during hospitalization.


Eligibility Criteria:
CA group

Inclusion Criteria:

* Occurrence of IHCA
* Hospital stay ≥48h.

Exclusion Criteria:

* \<14 years
* Do Not Resuscitat
* Patients hospitalized due to out-of-hospital cardiac arrest
* Cardiac arrest occurs during the operation
* The patients with implanted cardiac pacemaker suffered cardiac arrest due to instrument malfunction.

CONTROL group

Inclusion Criteria:

* Without IHCA
* Hospital stay ≥48h

Exclusion Criteria:

* \<14 years
* Leave hospital without medical advice
A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults (MK-0991-066)

To evaluate the safety, tolerability, and efficacy of caspofungin for the treatment of esophageal candidiasis and invasive candidiasis to support the registration of caspofungin for these indications in China.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a confirmed diagnosis of esophageal candidiasis or invasive candidiasis for whom IV antifungal therapy is appropriate
* FOR ESOPHAGEAL CANDIDIASIS
* Participant has endoscopic evidence of esophageal candidiasis
* Participant has disease documented by symptoms consistent with esophageal candidiasis and positive stain or wetmount KOH of brushing or biopsy from endoscopy followed by positive culture for Candida or positive histopathologic evidence of Candida infection
* FOR INVASIVE CANDIDIASIS
* Participant has at least 1 positive culture of a Candida species from blood or other normally sterile body site obtained within 96 hours of study entry
* Participant has clinical evidence of infection within 96 hours before study entry
* Temperature \>100\^◦F (37.8\^◦F) on 2 occasions at least 4 hours apart or 1 determination of \>101\^◦F (38.3\^◦F) or clinically significant hypothermia \<96.8\^◦F (36.0\^◦C)
* Systolic blood pressure \<90 or ≥30 mm Hg decrease in systolic blood pressure from the participant's normal baseline
* Signs of inflammation at a site infected with Candida

Exclusion Criteria:

* Participant has any of the following abnormal laboratory values: International Normalization Ratio (INR) \>1.6 or, if participant is receiving anticoagulants, INR \>4.0; bilirubin \>5 times the upper limit of normal range;

aspartate aminotransferase (AST, or serum glutamic oxaloacetic transaminase \[SGOT\]) or alanine aminotransferase (ALT, or serum glutamic pyruvic transaminase \[SGPT\]) \>5 times the upper limit of normal range

* FOR ESOPHAGEAL CANDIDIASIS
* Participant has Candida disease limited to the oropharynx
* Participant has another cause of esophagitis or has clearly defined ulcers on endoscopy with high likelihood of another non-Candida pathogen
* Participant has other esophageal pathology on endoscopy that is unrelated to acute esophageal candidiasis
* FOR INVASIVE CANDIDIASIS
* Participant has evidence of infection limited to a positive culture for Candida from urine, sputum, catheter tip, indwelling drain, or mucosal or superficial skin surface
* Participant has suspected Candida endocarditis, osteomyelitis, or meningitis