cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Chinese Healthy Adults

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics properties of TNM002 following a single intramuscular dose in Chinese healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female, 18-55 years of age;
2. Body mass index (BMI) within 19.0-26.0 kg/m2;

Exclusion Criteria:

1. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
2. Severe drug or excipient allergy, or history of hypersensitivity to other therapeutic mAbs;
3. History of alcohol or other substance abuse.
The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis

The efficacy and safety of Tofacitinib in patients with glucocorticoid resistant ICIs-related myocarditis: a single-arm, prospective, phase 2 trial


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Patients treated with ICI immunotherapy (monotherapy or combination), including anti-PD1, anti-PDL1, anti-CTLA4; and including any type of cancer (even those in which ICI is not currently approved by regulatory)
3. Definite, probable or possible ICI-induced myocarditis according to the diagnostic criteria of the most recent expert consensus recommendations (e.g27, to be updated with any new recommendations to be published)
4. corticosteroid-resistant ICI-myocarditis: Corticosteroid-resistant ICI-myocarditis is defined by the absence of decrease in troponin levels or the appearance/persistence of severity criteria despite receiving prednisone dose ≥0.5 mg/kg/day for ≥2 days.
5. Signature of informed consent before any trial procedure from the patient or legal representative or the close relative
6. Patients covered by social security regimen (excepting AME)
7. Withhold of ICI

Exclusion Criteria:

1. Untreated and/or uncontrolled bacterial, fungal, or viral infection Pregnancy, breast-feeding or planning to become pregnant during the study period
2. For women of childbearing age, lack of effective contraception throughout the duration of participation in the study
3. Being treated with tofacitinib within 3 months prior to inclusion Known hypersensitivity to abatacept or belatacept
4. Being treated with anti-thymoglobulin, or alemtuzumab within 6 weeks of the first scheduled dose of abatacept
5. Patient participating to another interventional study (RIPH 1 only) People under legal protection measure (tutorship, curatorship or safeguard measures)
PRophylaxis of Exposed COVID-19 Individuals With Mild Symptoms Using choloroquinE Compounds

To treat Pakistani patients with non-life threatening symptomatic SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different chloroquine and hydroxychloroquine dosing regimens in controlling SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic patients: defined as fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate \>22 per minute).
2. Nasopharyngeal RT-PCR positive SARS-CoV-2
3. Age 20-50 years
4. BMI 18-28 kg/m2
5. Informed consent

Exclusion Criteria:

1. O2 saturation by pulse-oximeter below 93%
2. Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
3. Arrhythmias and/or history of arrythmia
4. Psoriasis and/or history of psoriasis
5. Neuropathy or myopathy and/or history of these
6. Hypoglycemia and/or history of hypoglycemia
7. Pre-existing hepatic disease
8. Pre-existing renal disease
9. Use of antacids within 1 week
10. Use of antiobiotics within 1 week
11. Pregnancy
12. RT-PCR performed \>7 days prior to enrollment
The Durability of Early RA Disease Control After Tocilizumab Withdrawal: A Canadian Experience

Patients who participated in the FUNCTION Study (Protocol WA19926) will be enrolled in this study. The investigators want to learn how long it takes Early Rheumatoid Arthritis patients who were treated with Tocilizumab to require treatment with another biologic medication.


Eligibility Criteria:
Inclusion Criteria:

* Completed 2 years in the FUNCTION (WA19926) trial
* Patient has provided written informed consent and is willing to comply with the requirements of this study protocol

Exclusion Criteria:

* Requirement for immediate treatment with a biologic therapy following completion of the FUNCTION (WA19926) trial as per treating physician judgement.
* Presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of RA
Studying Biomarkers in Tumor Tissue and Blood Samples From Patients With Small Cell Lung Cancer Registered on CALGB-140202

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tumor tissue and blood samples from patients with small cell lung cancer registered on CALGB-140202.

OBJECTIVES:

Primary

* To identify the major genetic alterations in human small cell lung cancer (SCLC) using next-generation sequencing and focusing on mutations in coding sequence.

Secondary

* To follow up with in-depth assessment of candidate oncogenes and tumor suppressor genes using gene expression analysis, cell culture systems, and murine models of SCLC.

OUTLINE: DNA isolated from archived tumor tissue and blood samples are analyzed for genetic mutations and gene expression profiling using Illumina exome sequencing. Results are compared with transcriptome of tumors (or cell lines) with and without the specific mutation. Cell culture studies overexpressing or inhibiting the genes of interest are also performed in a mouse model to identified potential drivers of small cell lung cancer.

Eligibility Criteria:
* Patients must have been registered to CALGB-140202 trial in which tumor material (frozen tissue and paired blood specimens) is available
* Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
Rapid Antidepressant Effects of Leucine

This randomized double-blind placebo-controlled crossover study seeks to evaluate the antidepressant effect of L-leucine, an essential amino acid, in patients with Major Depressive Disorder (MDD).

This is a pilot phase II clinical trial of L-leucine to test its efficacy in reducing depressive symptoms in MDD patients, especially those who exhibit increased inflammation. The determination of increased inflammation will be done post-hoc. During the screening visit, all study participants will provide demographic information and complete self-report assessments and clinician evaluations and examinations. Blood and urine tests will also be performed. All participants who meet eligibility criteria and are willing to proceed with the study will enter this 6-week study after being randomized to two-week course of either L-leucine or placebo. In this cross-over study, participants will be crossed over to the second treatment after 2 weeks of washout. The study period will last 42 days (6 weeks) from the baseline visit. Both L-leucine and placebo will be provided as an effervescent mixture powder. Investigators hypothesize that MDD subjects will have greater reduction in depression severity on leucine as compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Current primary diagnosis of nonpsychotic major depressive disorder.
* Stable antidepressant dose of no more than one antidepressant medication for 4 weeks and no anticipated changes during the study period.
* Stable doses of all concomitant medications for over 6 weeks.
* No more than two failed antidepressant trials of adequate dose and duration, as defined by ATRQ, in the current episode.

Exclusion Criteria:

* Psychiatric co-morbidity posing safety risk.
* Pregnant or breastfeeding or plan to become pregnant over the ensuing 2 months following study entry or are sexually active and not using adequate contraception
* Exclusionary psychiatric conditions (such as substance dependence in the last 6 months, substance abuse in the last 2 months, or lifetime history of psychotic disorders.
* Unstable or terminal general medical condition (GMC).
* Concomitant medications that interact with L-leucine (e.g. sildenafil).
* Vagus nerve stimulation, ECT, or rTMS, or other somatic antidepressant treatment during current episode
* Inadequately controlled hypothyroidism.
* Therapy that is depression specific, such as CBT or Interpersonal Psychotherapy of Depression.
* Hypersensitivity to L-leucine
* Have Maple Syrup Urine Disease.
PD-1 Antibody (SHR-1210) Plus Capecitabine in Patients with Intrahepatic Cholangiocarcinoma After Surgery

SHR-1210 is a humanized anti-PD-1 Immunoglobulin G4 (IgG4) monoclonal antibody. This is an open- label,single center,non-randomized ,single arm exploratory study . This clinical study is an investigator-initiated clinical trial(IIT) .The objective of this study is to evaluate the efficacy and safety of therapy with anti-PD-1 antibody SHR-1210 plus Capecitabine in patients with Intrahepatic Cholangiocarcinoma After Surgery.


Eligibility Criteria:
Inclusion Criteria:

* age:18-75 years, male or femal;
* Intrahepatic Cholangiocarcinoma confirmed by histopathology, R0 resection was classified as Stage IB, Stage II, Stage IIIA, Stage IIIB, or Stage IA with histolgoic grade G3 according to AJCC TNM (8th edition, 2017);
* No extrahepatic metastases;
* preoperative assessment of Child-Pugh A，ECOG Performance Status 0-1;
* Subjects with chronic HBV infection must have HBV-DNA \<500 IU / ml;
* Functional indicators of vital organs meet the following requirements: Neutrophils ≥1.5\*109/L; platelets≥50\*109/L; hemoglobin≥90g/l; Alanine aminotransferase （ALT） and Aspartate aminotransferase （AST） ≤ 2.5 times ULN,total bilirubin≤1.5 ULN; International standardized ratio (INR) ≤2.3ULN,creatinine ≤1.5 ULN;
* No tumor recurrence or metastasis was observed.

Exclusion Criteria:

* Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer, hilar bile duct cancer;
* No anti-tumor treatment for Intrahepatic Cholangiocarcinoma, including chemotherapy and topical treatment, before surgery;
* Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation;
* Tumors are not completely removed, or postoperative pathology suggests non-Intrahepatic Cholangiocarcinoma or other malignant components;
* Subjects with any active autoimmune disease or history of autoimmune disease;
* Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
* Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
* Received a live vaccine within 4 weeks of the first dose of study medication;
* .Pregnancy or breast feeding;
* Decision of unsuitableness by principal investigator or physician-in- charge.
Effect of Different Form of Upper Limb Muscles Training on Dyspnea in COPD

Evaluate the effect of upper limbs strength training versus the effect of upper limbs endurance training, on dyspnea, in patients with COPD during a pulmonary rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* Patient with stage 2 to 4 (A to D) COPD admitted to a pulmonary rehabilitation program (4 weeks)
* Patient aged 18 or over
* Patient able to consent and having signed a consent form

Exclusion Criteria:

* Patient with pain, osteoarthritis or shoulder surgery
* Patient with a history of Pneumonectomy, lobectomy less than 6 months old
* Refusal of participation
* Patient with an inability to complete a pulmonary rehabilitation program in totality
* Pregnant or breast-feeding women
* Patient under tutorship or curatorship
Carbon Black Tattoo in Colon Cancer

The study is designed to elucidate whether carbon black suspension endoscopic tattoo enhances visibility of lymph nodes or tumor tissue on dissection of colonic surgical specimen, thereby making improvement in staging defined as better pTNM stage via better visualisation of carbon marked metastatic or sentinel lymph nodes or marked primary tumor or adjacent tissues.

Other objectives are:

* to assess intraoperative visibility of carbon black tattoo in the tumor region and surrounding tissues
* to assess microscopic distribution of carbon ink in the layers of the colonic wall and adjacent tissues
* to assess complications related to carbon black tattoo procedure like microscopic fibrosis, micro- or macroscopic scarring, inflammatory reactions
* to assess long-term effects of ink injections on control endoscopies at 6 and 12 months
* to assess dissection time in tattooed-non tattooed lymphatic tissues

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or above undergoing colonoscopy for suspected colonic malignancy
* Participant is able to give informed consent for participation in the study
* Patient is presumably selected for surgery within 30 days following tattoo injection

Exclusion Criteria:

* Patients under the age of 18
* Patients unable to give informed consent or ineligible for surgery
* Tumor in the coecum dome or in the rectum (\<15 cm)
* Known allergy to suspension ingredients
Transversal Multiaxial Evaluation and 5-year Follow-up of a Cohort of French Gamblers (JEU)

This study is divided into two stages. The first stage is a transversal study and corresponds to the recruitment of participants, which will last about two years. Three groups of gamblers will be constituted : Non-problematic gamblers (NPG), Problematic gamblers Not in Care (PGNC) and Problematic gamblers in Care (PGC).The second stage is a prospective 5-year follow-up study of the cohort (only the initial NPG and PGNC groups are concerned by the follow-up study), that consists on an annual follow-up evaluation. The main objective of the first stage of the study is to compare the characteristics of the three groups of gamblers on some socio-demographic and clinical data. These comparisons will allow us to identify, among all data, those that will be most likely to explain the evolution of the practice of gambling (appearance or resolution of a gambling problem), and recourse to specific care. These such isolated data will be tested in the second stage of the study, in order to determine those that are predictive factors of three steps of the gambling course of some gamblers : evolution of a controlled gambling practice into a problematic gambling practice, resolution of the problematic gambling practice without intervention of care, and first recourse to specific care.


Eligibility Criteria:
Inclusion Criteria:

* To be 18 to 65 years old
* To have gambled during the last year
* To gamble at least one time a year

Exclusion Criteria:

* To be under tutelage (a French protecting measure for persons with altered judgement)
* To present obvious cognitive disturbances
* To have difficulties to read and/or write in French language
Impact of Genetic Polymorphisms on Dental Implant Loss

Patients that may participate in this case-control study underwent dental implant surgery in the University Hospital in Ghent in 2004-2007.

According to one of our recent papers based on this patient group, 34/461 patients lost one or more implants. The goal is to invite these 34 patients, to update the anamnesis, to perform a brief clinical oral examination and to have a blood sample. The latter is necessary to identify relevant genetic polymorphisms of the patient that are associated with implant loss. Among the remaining patients that did not lose implants, another 34 'controls' will be invited for the same examinations.


Eligibility Criteria:
Inclusion Criteria:

* Dental implant surgery in the University Hospital in Ghent in 2004-2007.
* Case: dental implant loss
* Control: no dental implant loss

Exclusion Criteria:

-
6-Year Follow-up of a Prevention Program for Bereaved Families

Six-years following participation in the Family Bereavement Program (FBP) participants in the program as compared to a self-study control group will have lower levels of mental health problems, lower one-year prevalence of mental disorder that meets diagnostic criteria, lower use of substances, higher levels of competence at achieving developmentally appropriate tasks in academic achievement and social competence, and better self-esteem. The effects of the FBP will be moderated by baseline levels of mental health problems and gender. Bereaved caregivers who participated in the program will also show lower levels of mental health problems as compared with controls.

Program effects will be mediated by theoretical mediators targeted by the program.


Eligibility Criteria:
Inclusion Criteria:

* Experienced parental death in prior 30 months
* Youth age 8-16 years old

Exclusion Criteria:

* Not currently in other treatment for mental health problems
* Caregiver not meet criteria for clinical depression
* Youth not meet criteria for externalizing problems
* Not currently suicidal
Pharmacokinetic Properties of Lorcaserin in Obese or Overweight Elderly Subjects

The purpose of this study is to evaluate the PK properties of lorcaserin in obese or overweight elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females
2. Control (Adult) group: aged between 18 and 65 years (inclusive)
3. Elderly group: aged \> 65 years (includes subjects 1 day or more beyond the 65th birthday)
4. Able to give signed informed consent
5. BMI 27-45 kg/m2, inclusive 6. Eligible male and female subjects must agree not to participate in a conception process (i.e. active attempt to become pregnant or to impregnate, egg or sperm donation, in vitro fertilization).
6. Considered to be in stable health in the opinion of the Investigator

Exclusion Criteria:

1. Prior participation in any study of lorcaserin.
2. Clinically significant new illness in the 1 month before screening
3. Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
4. History of any of the following cardiovascular conditions:

   * Myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ECG), cerebral vascular accident (CVA), transient ischemic attack (TIA) or reversible ischemic neurologic deficit (RIND) within 6 months of screening
   * Cardiac arrhythmia requiring initiation of new medical or surgical treatment within 6 months of screening (stable medical therapy for \> 6 months, pacemakers and/or defibrillators implanted \> 6 months prior to screening are acceptable)
   * Unstable angina
   * History of pulmonary artery hypertension
5. Positive result of HIV, hepatitis B or hepatitis C screens
6. Initiation of a new prescription medication within 1 month prior to screening with the following exceptions:
7. Use of SSRIs, SNRIs, and other medications must meet washout period.
8. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging

The current surgical procedure for breast diseases places an emphasis on the conservation of breast skin in order to provide more optimal reconstruction.

The purpose of this study is to use portable, non-contact optical imaging device developed at the Beckman Laser Institute called Spatial Frequency Domain Imaging to detect the changes in a skin during reconstructive surgery procedure and healing process.

The researchers can use Spatial Frequency Domain Imaging instrument to measure the concentration of blood flow in the skin tissue and can determine of the changes that observed in the properties of the mastectomy flap that may be delay in healing process.

The imaging device can determine the change from baseline measurement to the development of skin necrosis, wound infection, or implant extrusion.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female 18 years and older scheduled for breast reconstructive surgery.

Exclusion Criteria:

* Minor and pregnant women
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis

The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Juvenile Rheumatoid Arthritis (JRA).

The purpose of this study is to determine if infliximab in combination with methotrexate is safe and effective in the treatment of patients with juvenile rheumatoid arthritis. The second purpose of this study is to see how children's bodies react to the combination of study drug and methotrexate. Patients will receive either infliximab at 3 mg/kg for 44 weeks or, placebo for 14 weeks followed by infliximab at 6 mg/kg for 30 weeks. Patients who complete the original study are eligible for additional treatment with 3 to 6 mg/kg of infliximab every 8 weeks for up to three years. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive either infliximab at 3 mg/kg for 44 weeks or, placebo for 14 weeks followed by infliximab at 6 mg/kg for 30 weeks. Patients who complete the original study are eligible for additional treatment with 3 to 6 mg/kg of infliximab every 8 weeks for up to three years

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of juvenile rheumatoid arthritis (JRA) with polyarticular JRA for at least 6 months, systemic JRA with a polyarticular course and no systemic symptoms (including fever, rash,hepatosplenomegaly, and serositis) for 1 year prior to study entry, or pauciarticular JRA with a polyarticular course for at least 6 months prior to study entry. The patient should have had at least 6 months of persistent synovitis before screening.
* The patient must have at least 5 joints with active arthritis (ie, presence of swelling, or if no swelling is present, limitation of motion accompanied by pain, tenderness, or both) at the time of enrollment, with at least 3 of these active joints having limitation of motion accompanied by pain, tenderness, or both
* The patient must be at least 4 years of age, but less than 18 years (ie, after the 4th but before the 18th birthday), with onset of disease before age 16.

Exclusion Criteria:

* Patient must not be pregnant, nursing, or planning a pregnancy within 6 months after the last study infusion
* Patient must not be incapacitated, largely or wholly bedridden, or confined to a wheelchair, or have little or no ability for age-appropriate self care
* Patient must not have a rheumatic disease other than JRA or any current systemic inflammatory condition (for example, Lyme disease,fibromyalgia, enthesitis-related arthritis, psoriatic arthritis, systemic lupus erythematosus, infectious or reactive arthritis, Reiter's syndrome, or parvovirus infection)