cyrilzakka/clinical-trials huggingface dataset:
Self-Control and Adult Cigarette Smokers

The purpose of this study is to learn more about self-control and adults who smoke cigarettes. It has been suggested that people can improve self-control by practicing tasks that require the use of self-control (such as delaying cigarettes or sitting up as straight as possible). The goal of this study is to learn about whether scores on self-control and other measures will change after one week of practicing self-control tasks at home. We believe that adults who smoke cigarettes will show better self-control after practicing tasks for a week.

The purpose of this pilot study is to examine a smoking-related self-control task and smoking behavior in adult smokers who are not motivated to quit smoking.

This pilot study will have a between-subjects design. All participants will be asked to complete two study appointments. First, they will complete a baseline appointment where they will review consent procedures. Participants who complete the consent forms will then be asked to fill out measures of demographics, smoking, and self-control. Smoking will be confirmed using expired breath carbon monoxide (CO) levels taken using a CO monitor. At that appointment participants will be randomly assigned to complete one of two self-control tasks: a task that is related to smoking (e.g., giving instructions to delay smoking when they have a craving) or a task that is not related to smoking (e.g., participants will be instructed to try to maintain the best posture possible (e.g., sit up straight, walk with good posture) as much as possible throughout each day Random assignment will be done using a random number generator and 50% of participants will be assigned to the smoking task while the other 50% will be assigned to the non-smoking task. Study staff will received standardized instructions to read to each participant about the task that they are assigned to practice during the week. Participants will be asked to practice their assigned self-control task every day for a week and to complete a brief series of questions about the effort and time spent practicing the task that day along with the number of cigarettes they smoked that day. After one week, participants will return for the second study appointment where they will report on their effort and time spent practicing the self-control tasks and complete additional measures of smoking and self-control.

Eligibility Criteria:
Inclusion Criteria:

1. Be adults who are 18 years of age or older
2. Currently smoke ≥10 cigarettes per day biochemically confirmed by an expired breath carbon monoxide (CO) level ≥8
3. Report that they are not currently attempting to quit smoking and not currently receiving smoking cessation treatment (e.g., counseling, nicotine replacement therapy, bupropion, varenicline)
4. Have the capacity to give informed consent
5. Be English-speaking.

Exclusion Criteria:

1. Children under the age of 18
2. Non-English speakers
3. Those who do not have the capacity to consent will be excluded from this study.
rTMS for the Treatment of Neuropathic Pain in Diabetic Patients

Tis study aims to assess whether multiple sessions of sham-controlled HF-rTMS applied to the motor cortex significantly reduces treatment-resistant neuropathic pain in diabetic patients.

This study will also investigate the effect of those rTMS sessions on functional connectivity of the M1 with brain areas involved in pain processing, underlying brain metabolism and brain plasticity using rs-fMRI, MRS and Paired-pulse stimulation respectively in those patients.

Subjects will be randomized into two groups to receive real or sham rTMS protocol. A washout period of at least 8 weeks will be respected between protocols to minimize carry-over effects. Sham stimulation will be delivered using a sham coil, providing the same auditory and sensory stimuli.

One daily rTMS session for 5 days of HF-rTMS, will be delivered through an H-coil applied to the primary motor area of the leg. Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100% of resting motor threshold (RMT), with an intertrain interval of 30s


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate in this study is obtained
* The subject is an out-patient aged 18 years or above with diabetes mellitus type 1 or 2
* The patient has laboratory-confirmed diabetes
* Patients are diagnosed with peripheral neuropathy based on clinical and electrophysiological findings
* A score of \> /= 4 on the the 'Douleur Neuropathique en 4 Questions' (DN4) questionnaire (30), conforming the diagnosis of neuropathic pain.
* The patient has a painful diabetic neuropathy for at least 6 months
* The patient has a Numeric pain rating scale (NPRS) score \>/= 4.
* The patient is resistant to standard therapies for neuropathic pain

Exclusion Criteria:

* The patient has an implanted cardiac device, such as a pacemaker or a defibrillator
* The patient has an implanted neurostimulator
* The patient has cochlear implants/ear implants, magnetic dental im-plants
* The patient has a drug infusion pump
* The patient has cerebral artery aneurysm clips
* The patient has a history of epilepsy
* The patient has a history of migraine or severe headaches
* The patient has significant psychiatric disorders
* For female patients: the subject is pregnant or lactating
* Other formal contra-indication for rTMS or MRI
A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations

An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in advanced or metastatic solid tumors with IDH mutation.

HMPL-306 is a dual IDH1/2 inhibitor

This is a phase 1, open-label, multicenter study to evaluate the safety and tolerability of HMPL-306 administered orally in the treatment of subjects with advanced or metastatic solid tumors with IDH mutation. The study consists of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). The dose escalation part will determine the MTD/RP2D. The dose expansion part will administer the MTD/RP2D to mIDH-positive solid tumor malignancies including, but not limited to, cholangiocarcinoma, skeletal chondrosarcoma, low-grade glioma, perioperative low-grade glioma

Eligibility Criteria:
Key Inclusion Criteria:

Subjects are eligible for enrollment into this study if they meet any of the following criteria (NOTE: This is not an exhaustive list):

* Subjects aged ≥18 years.
* ECOG performance status 0 or 1
* Subjects must have a documented IDH mutation per immunohistochemistry (IHC), polymerase chain reaction (PCR), or next generation sequencing (NGS) testing of tumor tissue.
* Subjects must have histologically or cytologically documented, advanced or metastatic solid malignancy of any type that has recurred or progressed on available standard treatment and for which no curative therapy exists.

Key Exclusion Criteria:

Subjects are not eligible for enrollment into this study if they meet any of the following criteria (NOTE: This is not an exhaustive list):

* Subjects who received an investigational agent \<14 days prior to their first day of study drug administration
* Subjects who are pregnant or breastfeeding
* Subjects with an active severe infection, some treated infections and with an expected or with an unexplained fever \>38.3°C during screening visits or on their first day of study drug administration.
* Subjects with some current or prior heart conditions
* Subjects taking medications that are known to prolong the QT interval may not be eligible
* Subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation
* Some subjects with some current or prior gastrointestinal or liver diseases
* Subjects with inadequate organ function as defined by the protocol
Convalescent Plasma vs. Standard Plasma for COVID-19

The purpose of this study is to find out if transfusion of blood plasma containing antibodies against COVID-19 (anti-SARS-CoV-2), which were donated from a patient who recovered from COVID-19 infection, is safe and can treat COVID-19 in hospitalized patients.

Antibodies are blood proteins produced by the body in response to a virus and can remain in the person's bloodstream (plasma) for a long time after they recover. Transferring plasma from a person who recovered from COVID-19 may help neutralize the virus in sick patients' blood, and/or reduce the chances of the infection getting worse.


Eligibility Criteria:
There are 2 groups of research subjects: plasma donor and recipients

Volunteer plasma donors can donate Convalescent Plasma if they:

* have adequate antibody levels against COVID-19 per FDA Guidelines
* have had no symptoms of COVID-19 for at least 14 days
* meet routine plasma donation criteria

Inclusion Criteria for Plasma Recipients:

* Adults 18 years of age or older
* Hospitalized with PCR+ COVID-19 infection
* If female must not be pregnant and/or breastfeeding.

Exclusion Criteria for Plasma Recipients:

* Unable to randomize patient within 14 days of admission to Stony Brook Hospital (or any other hospital if a transfer to Stony Brook Hospital).
* In the treating physician's opinion, the patient cannot tolerate a 450-550 mL infusion of plasma over up to 8 hours (4 hours max per unit), even if prophylaxed with intravenous diuretic
* Contraindication to transfusion or history of prior reactions to blood transfusions
Treatment of Tennis Elbow With Botulinum Toxin

The purpose of this study is to determine whether Botulinum A toxin is effective in the treatment of tennis elbow (lateral epicondylitis).

Tennis elbow (lateral epicondylitis) is a common cause of chronic elbow pain and wrist extensor dysfunction in adults, affecting 1% to 3% of the general population per year.

There is currently no consensus on its optimal treatment with wide-ranging options available. The best available scientific evidence suggests that only topical non-steroidal anti-inflammatory drugs and possibly, oral non-steroidal anti-inflammatory drugs may be useful for short term pain relief, while corticosteroid injections presented both benefits and harms as a short term measure.

Botulinum toxin has been reported in the treatment of lateral epicondylitis with promising results but these studies lack a control group bringing up the question whether recovery was a result of intervention or the natural history of the disease.

Method:

A twin-center, prospective, randomized, double-blind, placebo-controlled trial in which all patients received either a botulinum injection or a placebo saline injection.

Consecutive patients over 18 years old with tennis elbow referred to the outpatient clinic at the investigators' institution will be screened for this study. Eligible patients will be invited to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and up
* Pain at the lateral side of the elbow
* Pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension
* Pain for longer than 3 months

Exclusion Criteria:

* Previous operations (including previous steroid injections for the disorder)
* Nerve entrapment
* Pregnancy and while breast-feeding
* Presence of systemic neuromuscular disorders such as myasthenia gravis
When do School-aged Patients Return to School After ACL Surgery?

We intend to survey school aged patients following ACL surgery on when they return to school. We will analyze independent variables to determine if any relationship exists that may influence the amount of time missed.

All patients undergoing ACL surgery who are enrolled in middle or high school will be recruited for study participation. Patients undergoing concomitant additional ligament surgery will be excluded. The only procedure will be to answer a short written questionnaire asking when they returned to school and what accommodations, if any, the school made available for them. This will occur at the patient's 2 week post-operative clinic visit. This clinic visit is a standard of care visit. Independent variables will be collected from the medical record and are all standard of care information routinely collected from this patient populations (age, sex, race, date of surgery, surgeon, sport played, grade, ACL surgery graft type, associated meniscal or chondral surgery, length of post-operative narcotic use, regional nerve block at the time of surgery, SANE score, IKDC score, brace used).

Eligibility Criteria:
Inclusion Criteria:

* ACL reconstruction surgery
* currently enrolled in middle or high school (grades 6-12)
* Surgery occurs during the school year
* No concomitant additional ligament surgery (ie. PCL, MCL, LCL or MPFL)

Exclusion Criteria:

* patient is home schooled or in non-traditional school setting (ie. school for special needs)
* concomitant additional ligament surgery
* surgery occurs outside of the school year or on a scheduled break from school
A Study of LY3841136 in Healthy and Overweight Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3841136 in healthy and overweight participants. Blood tests will be performed to check how much LY3841136 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and may last up to 14 and 28 weeks for each participant and may include 7 and 19 visits in parts A and B, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential
* Have had a stable weight for the last 3 months
* Have a body mass index (BMI) in the range of 18.5 to 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of 27 to 40 kg/m², both inclusive (in Part B)

Exclusion Criteria:

* Are women who are lactating
* Have known allergies to related compounds of LY3841136 or any components of the formulation
* Have a history of significant atopy (severe or multiple allergic manifestations), or clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
* Have been diagnosed with Type 1 or Type 2 diabetes mellitus
* Have a history of chronic medical conditions involving the heart, liver, or kidneys
Impact of Impaired Cerebral Autoregulation on Postoperative Delirium in Elderly Patients Undergoing Spine Surgery

Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. There is very little information available about how often delirium occurs and the complications associated with it. Elderly patients are at high risk for delirium after surgery. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. The results from this study will provide important information on a possible mechanism and predictor of delirium.

Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. We hypothesize that impaired cerebral autoregulation may be a possible mechanism for postoperative delirium. We will measure intraoperative cerebral autoregulation and assess the relationship with postoperative dleirium. The results from this study will provide important information on a possible mechanism and predictor of delirium.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 70 years old,
2. Undergoing any lumbar spine surgery, posterior cervical spine surgery, or anterior cervical spine surgery \> 2 levels

Exclusion Criteria:

1. MMSE \< 15
2. Delirium at baseline
3. Inability to speak and understand English
4. Severe hearing impairment, resulting in inability to converse.
5. Planned use of intraoperative ketamine
6. Planned use of intraoperative remifentanil, except for airway management pre-incision.
7. Arterial catheter not planned to be inserted
CD19-CART Treatment for ALL

This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL.

Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring an artificial antigen binding receptor and also intercellular co-stimulating molecules into T cells. This kind of engineered T cells gains the ability to recognize antigen specific tumor cells and initiate the killing process in a HLA-independent way. CD19 is the specific cellular marker of B lineage acute leukemia (B-ALL), thus CD19-CART will be efficient in treating B lineage ALL. The investigators have constructed two kinds of CD19-CART. One is equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a humanized scFv. This study aims to evaluate the safety and efficacy of both murine and humanized CD19-CART in treating refractory or recurrent ALL.

Eligibility Criteria:
Inclusion Criteria:

1. previously identified as CD19+ ALL.
2. ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT.
3. Expected survival \>12W.
4. Creatinine \< 2.5 mg/dl.
5. Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) \< 3x normal
6. Bilirubin \<2.0 mg/dl
7. Voluntary informed consent is given.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Uncontrolled active infection.
3. Active hepatitis B or hepatitis C infection.
4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
5. Previously treatment with any gene therapy products.
6. Any uncontrolled active medical disorder that would preclude participation as outlined.
7. HIV infection.
Bioavailability and Metabolism of Anthocyanins Following Acute Cranberry Consumption

This study hypothesis is that anthocyanins from cranberry juice are bioavailable and can be measured in blood and urine after a single acute consumption of cranberry juice.

Little is known about the acute or chronic pharmacokinetics and metabolism of anthocyanins consumed in amounts relevant to usual dietary intakes. Thus, we hypothesize that anthocyanins from a single oral dose of cranberry juice will be absorbed quickly and can be measured in the circulation and urine within 2-4 h. Further, these anthocyanins will undergo a degree of metabolism but will circulate as well as be removed from blood as both parent compounds and metabolic products.

This research proposal is submitted as an independent sub-study of an existing project, "Effects of Cranberry Juice on Endothelial Function in Patients with Coronary Artery Disease", conducted by Joseph A. Vita, MD at the Boston University School of Medicine and sponsored by Ocean Spray Cranberries, Inc.

This study includes 15 subjects aged 21-80 y and with demonstrated endothelial dysfunction and angiographically proven coronary artery disease who will receive a single dose of 480 mL cranberry juice.

To test the hypotheses of the study to be conducted at HNRCA Tufts, we will utilize blood and urine samples that are already collected and stored. We will separate and analyze anthocyanins in these samples by HPLC and determine the pharmacokinetics of relevant anthocyanins.

Eligibility Criteria:
Inclusion Criteria:

* Stable CAD Patients
* Men \& postmenopausal women
* Aged 21-80 years
* All Ethnic Groups
* English Language

Exclusion Criteria:

* Subjects with heart failure are not eligible for participation in this study.
* Women with a positive urine beta HCG pregnancy test and lactating women or women who are planning to become pregnant.
* Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
* Regular use of oral steroids
* Cigarette smoking and/or nicotine replacement use
* Regular daily intake of ≥ 2 alcoholic drinks
* Illicit drug use
* History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
* No dietary supplements containing phenolic compounds, i.e., herbal preparations, or berry containing preparations (such as cranberry capsules) for one month prior to study admission.
* Treatment with an investigational new drug within the last 30 days.
Evaluation of a Digital Therapy of Auditory Training

The aim of the study is to evaluate the efficiency of the medical device AUDISSEE in improving the perception in noise ability of presbycusis patients with hearing-aids.

AUDISSEE is a digital therapy designed specifically to improve the hearing in noise of presbycusis patients by offering a complete cognitive auditory training, with verbal and non-verbal (especially musical) stimuli. This therapy is designed improve the comfort of life of people fitted with hearing aids by improving the observance of the wearing of their hearing aids. It is designed for the greatest number of people regardless of age or type of hearing aids and adapts to all levels of hearing loss (mild to severe).

In this study, 240 patients will be randomized in four groups. The first group will be trained with AUDISSEE-verbal, AUDISSE-non-verbal then with the placebo therapy. The second group will be trained with AUDISSEE-non-verbal, AUDISSEE-verbal, then with the placebo therapy. The third group will be trained with the placebo therapy then AUDISSEE-verbal, and AUDISSE-non-verbal. The fourth group will be trained with the placebo therapy then AUDISSEE-non-verbal, and AUDISSE-verbal.

Each training session will last 20 minutes. 3 sessions are planned per week, for 5 weeks for each sub-training. The protocol lasts 20 weeks in total for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* No neurological or psychiatric background
* No major cognitive deficit, able to understand and apply the recommendation
* Motivated to participate
* Have given its written consent
* Affiliated to a social security system
* Diagnostic of presbycusis by a health professional
* Hearing-aids since less than 2 years (no cochlear implants)
* No tinnitus
* With a possible access to a personal computer, tactile tablet or smart-phone to perform the training

Exclusion Criteria:

* Age below 18
* Pregnant or breastfeeding women