cyrilzakka/clinical-trials huggingface dataset:
Gentulizumab in Patients With Advanced Solid Malignancies and Non-Hodgkin Lymphoma

The purpose of this study is to assess the safety and tolerability of gentulizumab, an anti-CD47 Monoclonal Antibody, in participants with solid tumors and non-Hodgkin lymphoma.

This is a first-in-human, escalating dose trial of an antibody that inhibits an anti-apoptotic signal in human macrophages. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Eligibility Criteria:
Inclusion Criteria:

* The patient has the willingness to communicate with the investigator, can understand and follow the trial requirements, is willing to participate in the trial, understands and signs a written Informed Consent Form（ICF）, and is willing and able to comply with the visit schedule, administration plan, laboratory examination, and other clinical trial procedures.
* Gender: Male or female.
* Age 18-70 years old.
* Expected survival ≥ 12 weeks.
* Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Patients with advanced solid tumors or NHL by histopathological diagnosis do not have acceptable standard treatment currently.
* Adequate organ function per protocol-defined criteria.

Exclusion Criteria:

* Use of protocol-defined prior/concomitant therapy.
* Currently receiving or has received an investigational treatment as part of a study within 4 weeks before the first dosing.
* History of severe hypersensitivity reaction to study treatments or their excipients.
* Known active central nervous system metastases.
* History of any active autoimmune disease history, or disease or syndrome requiring treatment with systemic steroids or immunosuppressive medications.
* Presence of active infection.
* Known additional malignancy that has not been cured in the last 5 years.
* Any uncontrolled intercurrent illness or condition that in the judgment of the Investigator may endanger the patient.
Evaluation of PCLs Using Three EUS-FNA Needles

To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of mucinous (pre-malignant) and non-mucinous cysts.


Eligibility Criteria:
Inclusion Criteria:

* Pancreatic cystic lesion measuring 13mm or greater in largest diameter.
* Indicated for EUS evaluation of the PCL including EUS-FNA.
* Age 18 years of age or older.
* Willing and able to comply with the study procedures and provide written informed consent form to participate in the study.

Exclusion Criteria:

* Cysts in which FNA is not indicated based on review by the clinician, including potential concern of blood vessel location relative to the cyst.
* Requirement for anticoagulation using clopidogril, warfarin, or other long acting antiplatelet agents (with the exception of aspirin) that cannot be safely stopped according to institutional guidelines.
* Standard contraindications for EUS.
* Known pancreatic pseudocyst.
* Pregnancy.
A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.

To evaluate the efficacy of Bilastine ophthalmic solution 0.6% compared to vehicle and Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years old
* be willing and able to avoid all disallowed medications and contact lenses
* must have a pregnancy test if of childbearing potential
* must be able to read an eye chart from 10 feet away

Exclusion Criteria:

* must not have any allergies to the study medications
* must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
* must not have used immunotherapy in the last 2 years
* must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
Use of MRI and CTBS for Catatonia in Autism

Despite the significant morbidity and mortality associated with catatonia in autism, no diagnostic research has attempted to identify biomarkers for catatonia. This application will use a participant's own individual brain magnetic resonance image to target the primary motor strip with transcranial magnetic stimulation; to determine if hyper-excitability of the brain directly correlates with symptoms of catatonia and social-emotional impairment in autism. Completion of this project would result in the first study to associate hyper-excitability of the brain with catatonia and core features of autism; findings which are likely to have a significant impact on the health and well-being of autistic individuals.


Eligibility Criteria:
Inclusion criteria:

* Individuals aged 15-40 years of age will be enrolled. This age range was selected given the high degree of social development occurring in this life stage, the developmental nature of ASD, and ongoing cTBS-induced changes in MEP amplitude observed in AIC individuals as they age.
* Subjects and/or guardians must also be fluent in English, diagnosed with ASD based on DSM-5 criteria1 and Autism Diagnostic Observation Schedule-II (ADOS-II) assessment,78 and competent to assent to the study based on investigator clinical evaluation. Consenting guardians will be included if indicated.
* Subjects, or guardians if subjects cannot consent, must be competent to consent to the study. Subjects must be able to assent to the study as determined by clinical evaluation from the primary investigator.

Exclusion Criteria:

* History of substance abuse/dependence,
* History of concomitant major medical/neurologic illness
* History of seizure within one calendar year
* History of traumatic brain injury
* Pregnant or currently breastfeeding
* Are psychiatrically or medically unstable as determined by the investigator clinical evaluation
* Prescribed medication contraindicated in TMS
* Have a history of TMS treatment.
* Are diagnosed with a syndrome which results in ASD symptoms as preliminary research suggests individuals with these diagnoses have differing biomarker responses to TMS.26
* Children below the age of fifteen will also be excluded because of decreased likelihood of remaining still in the MRI scanner, as well as for scientific reasons surrounding unknown variability for key variables during pubertal onset.
* MRI scanning also introduces exclusionary criteria for conditions contraindicated to MRI, thus individuals with any bodily metal, history of claustrophobia, or pacemakers will be excluded.
* Expresses dissenting behaviors as outlined below.
Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors

This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent;
2. 18\~75 years old,male or female；
3. ECOG performance status 0 or 1;
4. Confirmed or suspicion of GEP-NET.

Exclusion Criteria:

1. Unable to lie flat for the entire imaging duration (e.g. persistent cough, claustrophobia, severe arthritis, etc.), unable to enter the PET/CT device;
2. Individuals planning to be pregnant, and lactating women;
3. Individuals with concurrent active infections or with unexplained fever \>38.5°C for more than 1 hour during the screening period or prior to administration of investigational medication.
A Clinical Study of Efinopegdutide (MK-6024) in Healthy Chinese Volunteers (MK-6024-011)

The goal of this study is to learn about the safety and whether people tolerate a study medicine called efinopegdutide. The study will also measure what happens to efinopegdutide in a healthy person's body over time.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body mass index (BMI) ≥25 and ≤35 kg/m\^2

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Had major surgery, donated or lost approximately 400 mL blood within 4 weeks prior to entering the study
Brief Integrative Therapy for Post-Traumatic Stress Disorder

The purpose of this study is to refine Brief Integrative Therapy (BIT) and to evaluate its effectiveness in treating women with Post-Traumatic Stress Disorder (PTSD) following childhood sexual abuse. This study will also promote the development of skills that are necessary for increasing quality of life and improving self-esteem.

BIT integrates interpersonal, problem solving, affect regulation, and psychoeducational components. In this study, BIT is used to encourage women to focus on current issues and problems. The BIT therapist will help patients identify the impact of PTSD on their functioning, help them identify effective coping strategies for dealing with trauma-related distress, and encourage them to establish and maintain a certain degree of independence from the therapist.

Patients receive 15 weekly sessions of BIT. Assessments occur pre-treatment, post-treatment, and at a 3-month follow-up, and include self-report measures, clinician administered PTSD scale questions, interviews, and evaluations of lifetime stressors.

Eligibility Criteria:
Inclusion Criteria:

* Post-Traumatic Stress Disorder (PTSD) diagnosis
* Childhood sexual abuse, defined as any sexual contact before the age of 16 with someone 5 or more years older
* At least 1 clear, detailed memory of sexual abuse

Exclusion criteria:

* Substance abuse or dependence
* Psychotic disorder, bipolar disorder, or dissociative disorder
* 2 or more suicidal or parasuicidal acts in the past year
* Domestic violence involvement
* Pregnancy or attempting to become pregnant
Study of Belimumab Administered Subcutaneously to Healthy Subjects

The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in healthy subjects.

This study is designed to evaluate the absolute bioavailability, pharmacokinetics, tolerability, and safety of a single dose (groups 1-4) or multiple doses (groups 5-6) of belimumab administered subcutaneously (SC) to healthy subjects.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy subjects defined as no clinically relevant abnormalities identified by a detailed medical history, full physical exam, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
* Body weight between 45 to 120 kg (99 to 264 lbs).
* Must agree to use effective contraception throughout the study and for 14 weeks after administration of belimumab.
* Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.

Key Exclusion Criteria:

* Pregnant or nursing.
* Test positive for drugs or alcohol or have had a drug or alcohol dependence within the past year.
* Have used any prescription medicines within the past 30 days or herbal/botanical supplements within the past 7 days or anticipate use during the study. May use prescription contraceptives, hormone replacement therapy, and over-the-counter medicines such as antihistamines or nutritional support such as vitamins, minerals, or amino acids.
* Have received a live vaccine within the past 30 days or anticipate receipt of a live vaccine during the study and within 4 months after last injection of belimumab.
* Have a history of an allergic or anaphylactic reaction to drugs, food, or insect bite or sting requiring medical intervention.
* Have a history of allergic reaction to contrast agents or biological medicines.
* Have participated in a clinical trial and received an experimental medicine within the past 60 days.
* Have received treatment with a B cell targeted therapy at any time.
* Have required management of an infection within the past 14 days.
Study of an Evening Dose of Eszopiclone on Next Day Driving Ability & Psychomotor/Memory Function in Healthy Volunteers

Male and female healthy volunteers. Patients must also possess a full current driving license (for at least one year), and be a regular car driver.

The study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 healthy male and female volunteers. The medications under investigation are eszopiclone and placebo. Volunteers will receive the study medications and placebo on the evening of Day 2 of each treatment period. Performance will be assessed on Day 3 of each treatment period. Each treatment period will be separated by at least a 7-day washout period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 55 years inclusive
* In good health as determined by a medical history, ECG, haematology, blood and urine biochemistry and physical examination by the doctor
* A body mass index greater than or equal to 18 and less than or equal to 30
* Registered with a general practitioner (GP)
* Hold a full current driving licence for at least one year, and be regular car drivers

Exclusion Criteria

* Clinically significant use of psychotropic medication in the last three months. For example, this would include the prolonged use of antidepressants, antipsychotics, or antihistamines, but would exclude the occasional use of cold or flu remedies (which often contain antihistamines and/ or opiates)
* The use of any other medication in the last two weeks with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol
* Significant history of mental illness, significant drug allergy, malignancy or chronic drug abuse (including alcohol)
* Any subject with known hypersensitivity to any of the study treatments
* A sleep/ wake cycle (e.g. shift work) liable to prejudice the results of the study
* Pregnant or lactating females, and females of child bearing potential not using effective contraception
* Volunteers who habitually smoke more than 5 cigarettes per day
* Caffeine consumption of more than 5 cups or glasses per day
* History of alcohol or drug dependence or intake of more than the equivalent of 14 units of alcohol per week for females and 21 units per week for males
* Current participation in another clinical trial, or participation in a clinical trial within the last 90 days
Predictors of Teen Smoking-cessation

The primary objective of this research is to explore relations between impulsive behavior and smoking-cessation success among treatment-seeking teens enrolled in a quit-smoking program.

It is hypothesized that teens who do not successfully stop smoking (or who drop out of the treatment program) will be more impulsive (from measures taken just prior to treatment) than those who do successfully stop or significantly reduce rate of smoking.


Eligibility Criteria:
Inclusion Criteria:

* Ages of 13 and 19
* Enrolled in the NOT program offered by Nationwide Children's Hospital
* Currently smoke at least one cigarette per day

Exclusion Criteria:

* Adolescents must be English speaking
Ticagrelor or Prasugrel Versus Clopidogrel in Elderly Patients With an Acute Coronary Syndrome and a High Bleeding Risk: Optimization of Antiplatelet Treatment in High-risk Elderly

A randomized controlled, open label, multicenter trial with 1000 patients aged 70 years and older, presenting with Non-ST-elevation acute coronary syndrome. Patients will be randomized to either clopidogrel or the novel P2Y12 inhibitor (ticagrelor or prasugrel). Patients will be followed for one year for outcomes such as bleeding episode requiring medical intervention and net clinical benefit (all cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding).


Eligibility Criteria:
Inclusion Criteria:

* At least 70 years of age.
* Hospitalization for NSTEMI or UA \< 72 hours

Exclusion Criteria:

* Contraindication to P2Y12 inhibitors i.e. clopidogrel, prasugrel or ticagrelor:
* Unable or unwilling to give informed consent or have a life expectancy of less than one year.
* Having received thrombolytic therapy within the previous 24 hours.
* Severe renal function impairment needing dialysis.
* Confirmed or persistent severe hypertension (Systolic Blood Pressure (SBP) \> 180 mmHg and/or Diastolic Blood Pressure (DBP) \>110 mmHg) at randomization.
* At increased bleeding risk, at the investigator's opinion, e.g. because of malignancy.
* Cardiogenic shock (SBP ≤ 80mmHg for \>30 mins) or Intra-Aortic Balloon Pump (IABP) at the time of screening.
* History of major surgery, severe trauma, fracture or organ biopsy within 90 days prior to randomisation.
* Clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator's opinion.
* ACS under dual antiplatelet therapy, e.g. aspirin with a P2Y12 inhibitor; clopidogrel, prasugrel, ticagrelor.
* Patients with a known CYP2C19 genotype at the time of randomization.
Pharmacokinetic and Safety Study of Cenicriviroc and Acid Reducing Agents When Dosed Alone or in Combination

This is a Phase 1, Single and Multiple-Dose, Open-Label Study in Healthy Subjects to Assess the Effect of the Acid Reducing Agents, Omeprazole and Famotidine, on the PK of CVC


Eligibility Criteria:
Inclusion Criteria:

* Be informed of the nature of the study and have provided written informed voluntary consent.
* Have a BMI ≥ 18.0 and ≤ 35.0 kg/m2.
* Be in good general health with no clinically relevant abnormalities based on medical history, physical examination, clinical laboratory evaluations (clinical chemistry, hematology, urinalysis), and 12-lead ECG that, in the opinion of the Investigator, would affect subject safety.
* Be able to communicate effectively with the Investigator and other study center personnel and agree to comply with the study procedures and restrictions.

Exclusion Criteria:

* Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease, as determined by the Investigator and, if necessary, the Sponsor's Medical Monitor.
* History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy which will be allowed.
* Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication.
* History of GERD, heartburn, or nausea more than once a month, or any similar symptoms requiring the regular use of antacids, or any use of H2 histamine blockers or proton-pump inhibitors over the past 3 months.
* History of achlorhydria, pernicious anemia, or peptic ulcers over the past 6 months.
* Have a positive Helicobacter pylori urea breath test.
* Known or suspected hypersensitivity or allergic reaction to any of the components of CVC, OME or FAM tablets.
* History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
* If female, is pregnant or breast feeding, or has a positive pregnancy test result prior to the first dose of study medication.
Telecoaching to Improve Physical Activity in Patients With Obstructive Sleep Apnea

Patients with obstructive sleep apnea (OSA) are less physically active than healthy controls.

First choice of treatment for OSA is continuous positive airway pressure (CPAP) therapy with an improvement in oxygen saturation and sleep. No improvement on physical activity has been shown.

The current study would randomize patients in a standard care group (CPAP) and an intervention group (CPAP + telecoaching). Telecoaching will be performed for 3 months, with physical activity assessment before, after 3 months and 12 years.


Eligibility Criteria:
Inclusion Criteria:

* AHI \> 15 events/hour, measured by polysomnography
* \< 7,500 steps per day
* Willing to start CPAP treatment
* Age between 18 and 65 years
* Signing the written informed consent

Exclusion Criteria:

* Patients with neuromuscular diseases
* Patients with chronic obstructive pulmonary disease and interstitial lung disease
* Patients with cardiac failure and ischemic heart failure
* Patients with comorbidities which could interfere with a normal biomechanical gait pattern and the possibility of increasing physical activity
* Patients with mental disability making it impossible to understand the study protocol and the use of electronic devices.
A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure

This study will randomize participants with a diagnosis of congestive heart failure and at least one risk factor for hospitalization to either a tablet computer and web based disease management program or a telephone based disease management program. Both interventions are home based with heart failure education and symptom monitoring provided by nurse managers. The nurse managers are in close communication with both the participants and the participants' physicians . The components of the disease management program have been developed at Tufts Medical Center and the New England Quality Care Alliance with studies showing improved clinical outcomes, including reduced hospitalizations. The goal of this study is to transition this successful home monitoring and disease management program to a tablet computer and web-based implementation to both improve clinical outcomes (reducing hospitalizations and improving self-perceived health status) and improve provider-patient satisfaction. We hypothesize that the tablet computer based disease management will decrease heart failure hospitalizations.


Eligibility Criteria:
Inclusion Criteria:

1. Patients age ≥ 18 with a primary care provider or specialist that is participating within the Collaborative Health ACO.
2. Patient able to consent
3. A diagnosis of heart failure with at least one of the following risk factors:

   * Hospitalization for heart failure within the prior year
   * NYHA class III-IV symptoms
   * Most recent BNP ≥ 300 pg/mL (or Nt-proBNP ≥ 600 pg/mL) as long as within 90 days prior to enrollment

Exclusion Criteria:

1. Acute myocardial infarction, PCI or CABG within 30 days before enrollment
2. Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization.
3. Illness other than heart failure deemed the principal limitation to life expectancy or principal cause of disability
4. Severe angina as the principal cause of limitation
5. Uncorrected valvular disease, except where valvular regurgitation was considered to be secondary to severe left ventricular dilation, or where surgical correction is deemed excessively risky or declined by the patient.
6. Moderate to severe dementia such that unable to participate in disease management program
7. Severe visual or auditory disability such that unable to participate in disease management program
8. Hospice care
9. Listed for heart transplantation
10. No access to a working telephone
11. Homeless or no stable home environment
12. Not speaking a language in which the educational documents have been translated