cyrilzakka/clinical-trials huggingface dataset:
A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of AK104，an anti- PD-1 and CTLA-4 bispecific antibody, in subjects with relapsed or refractory peripheral T cell lymphoma. The subject will receive AK104 450mg Q2W until unacceptable toxicity, confirmed disease progression, withdrawal of consent, or for a maximum of 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed advanced Peripheral T-cell lymphoma.
* Relapsed or refractory disease after at least 1 prior systemic treatment for the primary malignancy and not a candidate for other curative treatments.
* Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0 or 1.
* Adequate organ functions
* Effective methods of contraception.
* Ability to provide written informed consent and to be compliant with the schedule of protocol assessments.

Exclusion Criteria:

* Patients diagnosed as adult T cell lymphoma / leukemia (ATLL).
* Any prior exposure to PD-1/PD-L1、CTLA-4 targeting agents.
* Previous allogeneic stem cell transplant within 3 months prior to enrolment, active graft vs host disease (GVHD), or requiring transplant-related immunosuppression.
* Serious systemic infections or local infections during the 2 months before screening.
* History of cancer in 5 years before screening., including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
* Have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
* Has enrolled in any other trials during 3 months prior to screening or concurrently enrolled in any other trials.
* Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
* Subjects who received immunomodulatory drugs in 4 weeks before screening, including thymosin, interferon and interleukin, et al.
* Patients who received radiotherapy, chemotherapy, targeted therapy (except TKI), immunotherapy within 4 weeks before screening, and patients who received TKI drugs within 2 weeks before screening.
Effects of Cryotherapy on Ankle Function

The ankle joint is commonly used and also stricken by high loads and injuries in sports. One technique in emphasis is cryotherapy, a physiotherapeutical intervention characterized by the use of low temperatures for tissue trauma's rehabilitation. Several studies analysed the effects of cryotherapy and brought important results related to pain and strength reduction, also to muscle contraction speed reduction. Although, considering the risk-benefit from de intervention it's pertinent to observe the presence of deleterious effects, especially the ones that impact on motor function. This scenario has been brought by scientists and currently the main gap from this theme resides on the repercussions of the technique application on functional answers

Eighty participants will receive control (rest) and the experimental condition (cryotherapy), with an interval of 48 hours. The intervention group will undergo: i) assessment, ii) 20 minutes of cryotherapy, iii) reassessment, iv) 20 minutes of rest and v) reassessment, while the control group remains at rest for 20 minutes. Assessments will be composed of ankle function by the modified star excursion balance test, muscle tone by the myoton pro, skin temperature by a thermographic camera, thermic comfort, perception of balance and beliefs in cryotherapy. Data will be described using mean and standard deviation and compared by Mixed ANOVA (time x intervention) with post Bonferroni tests, with significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 28 years old
* healthy
* no musculoskeletal complaints

Exclusion Criteria:

* failure to follow protocol
* complaints of injury or pain during the assessments
Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome

This study evaluates the therapeutic effects of hippotherapy in children with Prader-Willi syndrome. Half of children will participate in hippotherapy for 15 weeks (30 minutes per sessions, twice a week, total 30 sessions, private lesson), while the other half will not receive hippotherapy.

This study evaluates the therapeutic effects of hippotherapy in children with Prader-Willi syndrome. Half of children will participate in hippotherapy for 15 weeks (30 minutes per sessions, twice a week, total 30 sessions, private lesson), while the other half will not receive hippotherapy.

The primary purpose of this study is to investigate effect of hippotherapy on motor function of Prader-Willi syndrome patients.

The secondary purpose is to compare motor function, obesity, and behavior of the children after the intervention with those parameters before the intervention.

Eligibility Criteria:
Inclusion Criteria:

* can sit upright on the static surface
* can follow one step command

Exclusion Criteria:

* body wight \> 35 kg
* serious medical conditions such as cardiac disease, pulmonary disease, uncontrolled epilepsy
* visual impairment, hearing impairment
* bleeding tendency, anticoagulation
* fracture within 6 months, major orthopedic surgery within 1 year
Suvorexant for Opioid/Stimulant Co-use

This study will evaluate whether Suvorexant 20mg reduces drug use and craving, and improves sleep and stress among persons with co-occurring opioid use disorder and stimulant use disorder.

This between-subjects, double-blinded, randomized controlled pilot study will recruit patients who are receiving methadone or buprenorphine treatment for OUD and are using cocaine. Participants will be randomly assigned to receive up to 30-days of Suvorexant (SUVO) or placebo. They will visit the clinic regularly to provide urine drug screens and complete questionnaires and will wear a device that can measure their sleep parameters. We expect that relative to persons who receive placebo, individuals who receive SUVO will 1) be less likely to screen positive for cocaine and/or opioids on urine drug screens, 2) will report lower drug craving, 3) will have longer total sleep time, 4) will report fewer insomnia symptoms, and 5) will report overall lower stress than persons who receive placebo. We also expect that patients will not have side effects from SUVO. These preliminary data will inform whether this FDA-approved medication may help patients stop co-using opioids and stimulants, which can be scaled up to reduce public health consequences related to co-use.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-65,
2. Meet criteria for stimulant use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR)
3. Currently receiving methadone or buprenorphine treatment for OUD and considered to be stable on current dose for at least 30 days
4. Willingness to engage with study protocol
5. Use of birth control (as appropriate)

Exclusion criteria:

1. Psychiatric or medical conditions that are judged by the investigators to interfere with participation or that are contraindicated for use with SUVO
2. Pregnant or breastfeeding
3. Current use of benzodiazepines, tranquilizers, or other schedule IV sleep medications
4. Moderate or severe substance use disorder other than opioid or stimulant use disorder
5. SUVO consumption in the last 30 days
6. Use of medications that are contraindicated with the study
7. Past 30-day suicidal behavior
8. Use of continuous positive airway pressure (CPAP) device for sleep apnea
Cardiovascular Risks and Urinary Albumin Excretion(UAE) in Polycystic Ovarian Syndrome (PCO)

PCO patients will be assessed clinically,urine \& blood samples will be tested. Systolic \& diastolic blood pressure, serum glucose \& insulin levels, lipid profile, C-reactive protein, complete hormonal profile, and Urinary albumin excretion will be measured.

PCO patients with 2 of 3 criteria: oligo- or anovulation ; hyperandrogenism \&polycystic ovaries. Exclusion criteria: pregnancy, diabetes, hypertension , adrenal \& thyroid dysfunction.

Blood samples after overnight fast (8hrs) at day 2 or 3 of menstrual cycle. Serum concentration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin, total testosterone \& sex hormone binding globulin, serum 17-hydroxy (OH) progesterone \& dehydroepiandrosterone sulfate will be measured.

Oral glucose tolerance test \& plasma insulin levels will be measured. Total cholesterol, triglycerides, high\& low density lipoproteins. Urinary albumin will be measured\& all the data will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* PCO patients

Exclusion Criteria:

* pregnancy
* diabetes
* hypertension
* adrenal dysfunction
* thyroid dysfunction
A Study of Oral LY317615 in Relapsed or Refractory Diffuse Large B-Cell Lymphomas.

This study will measure the effectiveness and any side effects of LY317615 in participants with diffuse large B-cell lymphoma (DLBCL: a sub-type of Non-Hodgkins Lymphoma).


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of recurrent or refractory DLBCL.
* Adequate organ functions.
* Able to swallow capsules.

Exclusion Criteria:

* More than 3 prior treatments for this disease.
* Serious heart problems.
Screening for Early Lung Cancer in Shanghai, China

Imaging procedures including chest X-ray and low-dose computed tomography may be effective in lung cancer early detection. Yet it is unknown whether low-dose computed tomography combined with computer aided detection （CAD) is more effective than LDCT in screening of early lung cancer.

The randomized clinical trial is to investigate and compare the effectiveness of CAD-guided low-dose computed tomography and low-dose computed tomography in lung cancer screening for community individuals in Shanghai, China. Thus, an imaging protocol which can detect early lung cancer in asymptomatic high risk patients will be proposed.

Eligibility Criteria:
Inclusion Criteria:

* Age of 55 to 74 years; smoking history of at least 30 pack-years; and if former smoker, have quit within 15 years
* Age 50 or older ,20 or more pack-year history of smoking, and one additional risk factor (occupational exposure, residential radon exposure, cancer history, family history of lung cancer, history of lung disease)
* Age 35 and one additional risk factor
* Ability to accept LDCT examination and sign informed consent form

Exclusion Criteria:

* Individuals with any symptoms suggestive of lung cancer （e.g., vigorous coughing, chest pain, weight loss, blood-stained sputum）
* Individuals with acute pulmonary abnormalities or those in poor health conditions or those have metallic implants or devices in the chest or back will be excluded due to the potential impact on the results as well as difficulty of acquiring the images.
* Pregnant women
Evaluation Of The Effectiveness Of Safe Nutrition Program Applied To Acute Stroke Patients With Dysphagia

It was planned in a quasi-experimental design with a non-randomized control group. The study was planned to be completed in three stages: control, preparation and intervention periods.

Question 1: Does a safe nutrition program prevent aspiration pneumonia, dehydration and malnutrition in acute stroke patients with dysphagia? Question 2: Is the safe nutrition program effective on addiction level, quality of life and depression in acute stroke patients with dysphagia? Question 3: Does a safe nutrition program shorten the hospital stay and NG tube duration in acute stroke patients with dysphagia?

Introduction: Dysphagia is a common complication in acute stroke patients. Although there are treatment options, healing takes time. Managing this process in the safest way is important for the physical and mental health of the patient.

Purpose: This study aimed to evaluate the effectiveness of a safe nutrition program applied to acute stroke patients with dysphagia.

Eligibility Criteria:
Inclusion Criteria:

* acute stroke patients
* 18 years and over

Exclusion Criteria:

* those who do not want to be involved in the study
Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension

The purpose of this study is to test the hypothesis that treating PAH-CHD patients preoperatively with PAH drugs and keeping them on treatment for six months after surgery reduces the risk of immediate postoperative death and the risk of residual PAH at six months following operation to \<10%.

Pulmonary arterial hypertension (PAH) is a complicating factor in the management of congenital heart disease (CHD) with intracardiac or extracardiac communications. In children with moderate to severe PAH, the risk of serious complications following the surgical repair of shunts (including right cardiac failure and death) is 15-20% or even higher, and the risk of late, postoperative residual PAH is \~25%. We therefore intend to conduct a study aimed at reducing the risk of severe immediate postoperative complications and the risk of residual PAH at six months following surgery to less than 10% in children with moderate PAH (primary objective). The study is also aimed at promoting a statistically significant reduction in pulmonary artery pressure and pulmonary vascular resistance at six month after surgery, compared with baseline in children with moderate or severe PAH (secondary objective). We hypothesized that these goals could be achieved by treating patients preoperatively and for six months postoperatively with sildenafil, either singly or combined with bosentan. Both drugs have been approved for treatment of PAH on the basis of randomized clinical trials. Preoperative and postoperative (on treatment) hemodynamic evaluation will be based on noninvasive and invasive diagnostic procedures. As an additional objective, we intend to analyze possible abnormalities in genes that have been shown to be associated with PAH-CHD, and inflammatory mediators as well. The idea is to investigate whether changes in these markers correlate with the clinical profile and response to treatments.

Eligibility Criteria:
Inclusion Criteria:

* Potentially operable patients with congenital cardiac septal defects (bi-ventricular physiology) and PAH, must have at least three of the following severity criteria: age \> 18 months; absence of congestive heart failure (pulmonary congestion); Down syndrome; bidirectional shunting across the septal defect; periods of systemic (peripheral) oxygen saturation \< 90%.

Exclusion Criteria:

* Patients with complex cardiac anomalies for whom there are no possibilities of complete repair. Patients with uni-ventricular physiology.
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant

The purpose of this study is to find out whether it is practical to use a newer way to calculate melphalan dose given (called population PK model) in BEAM chemotherapy before AHCT. Standard dose is fixed for everybody and is calculated using height and weight. The population PK model, tested in this study, uses information based on people who have previously received melphalan and aims to calculate an optimal dose separately for each person. Study researchers think that the dose calculated using the population PK model may still be effective but have less side effects than the standard melphalan dose.


Eligibility Criteria:
Inclusion Criteria:

* Age18 - 79 years old
* Diagnosed with any type of lymphoma \[Hodgkin, non-Hodgkin (B- or T-cell)\] and planned for BEAM-AHCT
* KPS \> 70
* Cardiac ejection fraction of \> 45%
* Hemoglobin-adjusted diffusing capacity of carbon monoxide (DLCO) of ≥45%
* Creatinine clearance of ≥ 40 mL/min
* Completion of most recent systemic therapy within 12 weeks of enrollment
* Complete or partial response to systemic chemotherapy by IWG Working Group Criteria.
* Total bilirubin \< 2.0 mg/dL in the absence of suspected Gilbert's disease (if Gilbert's disease is suspected, the total bilirubin must be ≤3.0 mg/dL), and AST \& ALT \< 2.5 ULN.
* Minimum stem cell dose of 2 x 10\*6 CD34+ cells/kg

Exclusion Criteria:

* Disease progression by IWG Working Group since last therapy
* Pregnant or lactating females
* Contraindication to CE melphalan or any of the required supportive treatments, including hypersensitivity to G-CSF or pegfilgrastim
* Any known allergy or allergic reactions to Captisol
* Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial
Behavioral Activation and Medication Optimization In Older Adults Undergoing Cardiac Procedures

This Hybrid 1 Study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing cardiac surgery (compared with usual care), while examining implementation outcomes.


Eligibility Criteria:
Inclusion criteria:

* Adults ≥ 60 years
* Scheduled major cardiac procedure
* PHQ-ADS ≥ 10, indicating clinically significant depression or anxiety symptoms

Exclusion criteria:

* Barrier to communication (Unable to read, speak, and understand English)
* Severe cognitive impairment screened by the SBT (Short Blessed Test) \>10
* Acutely suicidal
* Previous participation in this study or CPMH feasibility study 202101103.
Psychostimulant Abuse - Novel Treatment Approaches - 1

To determine if acute assessments of profasi and factrel affect plasma cocaine levels and cocaine-induced behavioral changes in men.


Eligibility Criteria:
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Effectiveness and Safety Study for RWJ-333369 as Adjunctive Therapy in Korean and Japanese Patients With Partial Onset Seizures

The purpose of the study is to evaluate the effectiveness and safety of adjunctive RWJ-333369 at a dose of 200 or 400 mg/day in comparison with placebo in Korean and Japanese partial epilepsy patients who have poor seizure control with one or two antiepileptics (AEDs).

Despite the introduction of new antiepileptic drugs into overseas clinical settings after 1990's, there still exist those patients who cannot control seizures, and thus the advent of newer antiepileptic drugs is being desired. This is a multicenter, placebo-controlled, double-blind (neither the study physician nor the patient knows the name of the study assigned medication), randomized (study drug assigned by chance), parallel-group study. It consists of three periods: Pretreatment Phase (screening and baseline periods), Double-Blind Treatment Phase, and Posttreatment Phase (transitional period or dose-tapering/withdrawal period). Patients who complete Double-Blind Treatment Phase will be qualified to participate in the long-term extension study (Study 333369-KJ-03) following the present study. The primary hypothesis is that at 400mg/day of RWJ-333369 is effective in the adjunctive treatment of patients with partial onset epilepsy, as measured by the percent reduction from baseline in monthly seizure frequency of partial onset seizures. Safety is evaluated based on the following variables; Adverse event, Lab test, Electrocardiogram, Vital signs, Pregnancy test, Physician Withdrawal Checklist. Patients will receive the assigned dose (placebo, 200 mg/day, or 400 mg/day) twice daily orally for 12 weeks (85 days)

Eligibility Criteria:
Inclusion Criteria:

* Body weight of 40 kg or more
* Established diagnosis of partial epilepsy for at least 1 year
* Current treatment with at least one and no more than two antiepileptics (AEDs)
* At least 6 episodes of simple partial motor seizures, complex partial seizures, or secondarily generalized seizures for 2 months (56 days) during the baseline period (No seizure free interval for more than 3 weeks)

Exclusion Criteria:

* Diagnosis of status epilepticus or epilepsia partialis continua within 6 months
* Patients with generalized epileptic syndrome
* Current or previous history of non-epileptic seizures, including psychogenic seizures
* Current or previous history of any serious or medically relevant systemic disease, including clinically apparent hepatic disease, renal failure, malignant neoplasm, insulin-requiring diabetes mellitus, or any disorder
* Patients with clinical evidence of significant cardiac disease
* Current or past (within 1 year) major significant psychotic disorder
* Have an ALT (GPT) greater than 1.5 times the upper reference limit or total bilirubin above the upper reference limit at screening laboratory tests
Alzheimer's Disease Treatment and Illness Perceptions Survey (TIPS) II

The TIPS Study, or Treatment and Illness Perceptions Survey, is a study funded by the national Alzheimer's Association to learn more about differences between African Americans' and Whites' attitudes, beliefs, and experiences related to Alzheimer's disease (AD). The study involves a one-time 30-minute telephone survey in which participants are asked about a range of topics related to AD, including their personal experiences, their beliefs about the disease's symptoms and risk factors, and their attitude toward possible future treatment options. Information from the survey will be used to develop more culturally sensitive health education and healthcare services for persons with AD.

The main goal of the Boston University's TIPS II project is to examine differences in Alzheimer's disease (AD) illness perceptions between African Americans and Whites in order to better understand attitudes and beliefs and to develop more culturally sensitive health services for AD. This 30-minute telephone survey will include a total of 140 first-degree relatives and caregivers of people with AD, as well as a comparison group of 70 adults without family history. The researchers will assess 1) beliefs about AD; 2) the perceived threat it poses; 3) sources of information about AD; 4) knowledge of basic facts about AD; 5) appraisal of AD treatments; and 6) intentions regarding current and emerging care options. Based on preliminary data, this study hypothesize that, as compared to Whites, African Americans will report lower levels of perceived threat, fewer sources of information, less awareness of facts, and less interest in care options. Focus group interviews with African American participants will help interpret study findings and inform recommendations for health education interventions.

Findings will inform the development of a set of recommendations for AD health educators that will help them tailor their interventions to African Americans. Such educational programs promote increased use of assessment, treatment, and caregiver assistance services. Results will also be used as pilot data in a proposal for a national survey of caregivers and relatives. This program of research will address a growing need for increased understanding of beliefs, knowledge, and intentions regarding AD. A total of 210 participants are being sought (105 African Americans, and 105 Whites). Participants who complete the survey will be given a $10.00 check, plus informational brochures on AD and the latest newsletter from the Boston University Alzheimer's Disease Center.

Eligibility Criteria:
Inclusion Criteria:

Three groups of participants are sought to take part in the survey:

* 70 primary caregivers(current or former) of persons with AD, or related memory disorders
* 70 adult children and siblings of people with AD or related memory disorders
* 70 adults age 40 and older without immediate family history of AD or related memory disorders

Exclusion Criteria:

* Not fluent in English
* Cognitive impairment that would preclude responding to a 30-minute telephone survey