cyrilzakka/clinical-trials huggingface dataset:
Writing Activities and Emotions

The current study aims to test whether an online two-week positive psychological intervention can increase positive affect in college students. Participants will be recruited from the University of Pittsburgh undergraduate subject pool. Students will be ineligible if they are under the age of 18; currently prescribed medications for cardiac arrythmias; have a history of heart surgery, heart attack, or stroke; are currently pregnant; or currently have symptoms consistent with COVID-19. This study includes an active control arm and an intervention arm. Both arms will be required to complete writing activities every other day for two weeks. Participants in the control arm will list their daily activities, while participants in the intervention arm will complete various positive psychology activities. Questionnaires assessing mood, emotional well-being, social functioning and a few health behaviors will be administered pre- and post-intervention. The investigators aim to recruit 250 undergraduate students with the hope that at least 50 participants per group will complete the entire study.


Eligibility Criteria:
Inclusion Criteria:

* Must be an undergraduate student at the University of Pittsburgh that is currently taking Introduction to Psychology.
* Must be at least 18 years old
* Not currently prescribed medications for cardiac arrythmias
* Report no history of heart surgery, heart attack, or stroke
* Not currently pregnant
* Must deny having current symptoms consistent with COVID-19.

Exclusion Criteria:

* If the participant does not meet the inclusion criteria.
The Effects of Combined Lifestyle Intervention (CLI) in Patients With Inflammatory Bowel Disease (IBD)

A single-center observational study to investigate the effects of combined lifestyle intervention (CLI, in Dutch: gecombineerde leefstijlinterventie, GLI) in patients with Inflammatory Bowel Disease.

This is an exploratory observational study of IBD patients ≥ 18 years old with a BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 and an increased risk of diabetes or cardiovascular disease, who are or have been referred to the CLI.

During the 2-year CLI program, fitness measurements take place according to CLI protocol and by the CLI provider: bodyweight, BMI, waist circumference, fat percentage and the EQ-5D-5L are recorded at baseline and 1-year and 2-year timepoints. Whilst patients are offered a CLI referral, willingness to partake will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old;
* Diagnosis of IBD (Ulcerative Colitis, Crohn's Disease or IBD-Unclassified) confirmed by clinical, endoscopic, and histological evidence prior to screening as per standard criteria;
* BMI ≥ 30 mg/kg2 or a BMI between 25 and 30 mg/kg2 and an increased risk of diabetes or cardiovascular disease;
* Patients that are or have been referred to the CLI;
* Oral informed consent must be obtained and documented in EPIC.

Exclusion Criteria:

* Serious underlying disease other than IBD that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study or would compromise subject safety (such as major neurological disorders, certain orthopedic impairments or any unstable, uncontrolled or severe systemic medical disorder);
* If female, the subject is pregnant or lactating;
* Illiteracy (disability to read and understand Dutch).
Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation

Stroke, one of the most common causes for acquired adult disability, is not only a burden for the individual but also for his or her close relatives and caregivers. Functional recovery is commonly associated with the re-acquisition of lost skills. This skill (re-)acquisition is separated into different phases during which learning takes place while the skill/movement is actively performed - so called online learning - or during the time of non-performance between the training - so called offline learning or consolidation. During the initial phase of training, performance improvements are commonly steep (online learning). During the following processes of consolidation, which often depend on sleep, memory traces are being modified and stored for long-term memory retention leading to a further improvement without additional training (offline learning). Previous studies focusing on individuals after stroke could show a beneficial effect of sleep on motor skill acquisition. As an intervention, transcranial electrical stimulation (tES) with motor tasks could show beneficial effects on motor skill acquisition. tES is a method to stimulate an area of the brain non-invasively and this is done by applying low voltage current to the scalp that lies in close proximity to the target brain region. In the current study, stimulation is performed during sleep and types of stimulation resemble natural sleep physiology: slow-wave and spindles. As slow-wave and spindles are shown to be important for memory consolidation, it is hypothesized that applying physiologically-inspired stimulation could enhance memory consolidation in individuals after stroke. It is known that patterns of sleep physiology change in older individuals, thus, this population is also investigated in the current study. It is interpreted and discussed that older individuals do not benefit from sleep as much as younger individuals do. Thus, it is hypothesized that applying physiologically-inspired stimulation could enhance memory consolidation in healthy older individuals.


Eligibility Criteria:
Inclusion Criteria:

* right handed (healthy older)
* healthy (healthy older)
* monohemispheric stroke (individuals after stroke)
* at least 6 months since diagnosis stroke (individuals after stroke)

Exclusion Criteria:

* Unable to provide informed consent
* Pregnancy
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant
* Non-compliance to the instructions of the experimenter or an inappropriate behaviour hindering the normal progress of the experiment
* Previous enrolment into the current study
* Exclusion criteria tES, and transcranial magnetic stimulation (TMS)
* Use of psychoactive medication, which might influence the study results
* Request of not being informed in case of incidental findings
* Recurrent stroke / multiple strokes (individuals after stroke)
* Cerebellar stroke (individuals after stroke)
A Study of BMS-986205 Alone and in Combination With Nivolumab in Chinese Patients With Advanced Malignant Solid Tumors

The purpose of this study is to determine safety and effectiveness of experimental medication BMS-986205 in combination with Nivolumab in patients with cancers that are advanced or have spread.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologic or cytological confirmation of a solid tumor that is advanced with measureable disease per RECIST v1.1
* Participants must have received, and then progressed or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting
* Participants must have an ECOG performance status of less than or equal to 1
* Participants must have at least 1 lesion with measurable disease as defined by RECIST Version 1.1

Exclusion Criteria:

* Participants must not have suspected, known, or progressive CNS metastases, have untreated CNS metastases, or have the CNS as the only site of disease
* Participants with prior exposure to anti PD-1 or anti-PDL1 therapy
* Participants must not have a history of allergy to any of the study treatment components
Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet

to evaluate the efficacy and safety of CKD-828, D326, and D337 combination therapy in Hypertensive patients with Dyslipidemia

The purpose of this phase III study was to evaluate the efficacy and safety of CKD-348(CKD-828, D326, D337) tablet administration for treatment period(8 weeks) in essential hypertesive patients with Dyslipidemia.

Eligibility Criteria:
Inclusion Criteria:

1. Between 19 years and 75 years old(male or female)
2. Diagnosed essential hypertensive patients with dyslipidemia or the patients who has been taking antihypertensive and antidyslipidemic drugs
3. The patients who can stop taking antihypertensive and antidyslipidemic drugs accroding to Principle Investigator's opinion
4. Agreement with written informed consent

Exclusion Criteria:

1. Patients whose blood pressure measured at screening is one of the following:

   * Mean Sitting Systolic Blood Pressure ≥ 200 mmHg or Mean Sitting Diastolic Blood Pressure ≥ 120 mmHg
   * Difference in Mean Sitting Systolic Blood Pressure between patient's both arms ≥ 20 mmHg and Mean Sitting Diastolic Blood Pressure ≥ 10 mmHg
2. Patients whose lipid level measured at screening is one of the following:

   * Low Density Lipoprotein-C \> 250 mg/dL or Triglyceride ≥ 500 mg/dL
3. Patients diagnosed with secondary hypertension or suspected of secondary hypertension(coarctation of aorta, primary aldosteronism, etc).
TROMS (Trainee Reported Outcome Measurement): the New Era of Surgical Evaluation

TROMS (trainee reported outcome assessment): assessment of surgical training of residents in general surgery


Eligibility Criteria:
Inclusion criteria:

All surgical residents in the department of general and digestive surgery

Exclusion criteria:

Not applicable
Acceptance and Commitment Therapy (ACT) for Family Members After a First Psychotic Attack

This study aimed to evaluate the effect of ACT administered online to family members on self-stigmatization, coping with stress, and psychological resilience levels after the first psychotic attack (FPA).

This study is a pretest, posttest, follow-up, randomized controlled experimental study. This study will be conducted with family members of individuals diagnosed with FPA who come to the psychiatry outpatient clinic of a training and research hospital. According to the results of G-power analysis, the minimum sample size of the study was calculated as 32 (intervention 16, control 16). Personal Information Form will be applied to the individuals before randomization. The computer-aided https://www.random.org/integers/ program will be used to assign the intervention and control groups without bias. It is planned that the intervention group will consist of 8-12 participants and the program will be implemented as two intervention groups. The Acceptance and Commitment Therapy (ACT) Based Intervention Program will be implemented online in eight sessions. Each session will last 60-90 minutes on average. Two sessions will be held for one group per week. The control group will not receive any intervention from the researcher. The intervention groups will be followed up with a post-test after the program is completed and three months later, while the control group will be followed up with a post-test four weeks and three months later.

In the preparation of the interventions and planning of the sessions based on ACT, the researcher utilized studies in the literature and the basic ACT training she had received. The sessions were prepared based on six components of psychological flexibility found at the basis of ACT.

Eligibility Criteria:
Inclusion Criteria:

* Acceptance to participate in the research,
* Being responsible for the care of an individual who has been diagnosed with schizophrenia and other psychotic disorders according to DSM-5 diagnostic criteria at least six months ago and at most five years ago,
* Living with the patient for at least one year,
* First-degree relatives (mother, father, siblings, adult children and spouse),
* The home environment is suitable for online interviewing (having a computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.),
* Being literate,
* Communication is not a problem.

Exclusion Criteria:

* Refusal to participate in the research,
* Responsible for the care of an individual diagnosed with schizophrenia and other psychotic disorders for less than six months or more than five years according to DSM-V diagnostic criteria,
* Living with the patient for less than one year,
* No first-degree relatives (mother, father, siblings, adult children and spouse),
* The home environment is not suitable for online counseling (having a computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.),
* Illiteracy,
* Communication problems.
IL-12RB and TNF-alpha Gene Polymorphism and Susceptibility and Progress of Covid-19 SARS-CoV-2: A Case Control Study

A novel coronavirus was identified in late 2019 in Wuhan, China On 11 February, The International Committee on Taxonomy of Viruses (ICTV) announced that the official classification of the new coronavirus (2019-nCoV) is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) announced on the same day that the official name of the disease caused by the virus is Corona Virus Disease-19 (COVID-19). WHO has declared the infection a Pandemic on March 11, 2020. Based on previous studies on SARS in 2003 and SARS-MERS 2013 there was a genetic polymorphism associated with the susceptibility and severity of the disease.

Interleukin-12 (IL-12) is a cytokine secreted by activated phagocytes and dendritic cells. It plays a pivotal role in promoting Th1-type immune responses and cell-mediated immunity. IL-12 triggers many biological functions: it stimulates the proliferation of activated T- and NK-cells, enhances T- and NK-cell-mediated cytolytic activity, and induces the production of IFN-γ by both T-and NK-cells. The interferon-γ production induced by IL-12 forms a major link between innate and adaptive immunity. A recent study revealed that interferon-mediated immunopathological events are associated with atypical innate and adaptive immune responses in SARS patients.

Also, TNF-α is a key mediator of the inflammatory response and is critical for host defense against a wide variety of pathogenic microbes. However, the over-expression of this cytokine may lead to badness in disease recovery. The dual role of TNF, acting as an agent of both innate immunity and inflammatory pathology, poses a considerable challenge for gene regulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed COVID-19 PCR ( mild, moderate and severe cases) admitted to wards or ICU Assiut University Hospitals

Exclusion Criteria:

* Suspected or non confirmed cases of COVID-19
Severe Congenital Hemostatic Defects, Cerebral MIcrobleeds and COGnition

Cerebral microbleeds (CMBs) are haemosiderin deposits, resulting from the leakage of erythrocytes from small cerebral vessels, which can be detected noninvasively using susceptibility-sensitive magnetic resonance imaging (MRI) techniques. CMBs are commonly observed in daily practice: their prevalence range from five percent in healthy individuals over 65 years old to 50% in patients with a history of stroke. CMBs are associated with intracerebral hemorrhage (ICH) and also cognitive impairment and dementia.

The pathophysiology of CMBs is thought to primarily involve damage to brain microvasculature but the exact underlying cascade of events, including a potential role for haemostasis, has yet to be elucidated. Haemostatic defects (congenital or acquired) may contribute to an increased number and importance of CMBs. Congenital bleeding disorders such as haemophilia or von Willebrand disease (vWD), populations at high risk of ICH, are unique conditions that may give us further insights into a potential role of haemostatic defects in the pathophysiology of CMBs. CMBs might be the missing link between severe haemostatic defects, ICH risk and cognitive function.

We hypothesized that severe congenital haemostatic defects could contribute to an increased prevalence and number of CMBs, with an impact on cognition in adulthood.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, older than 18 years old, no upper age limit
* Adult patients with a severe congenital haemostatic defect

  * Severe or moderate congenital haemophilia A (or B) defined as \<5 IU/dL (\<5%) endogenous FVIII (FIX) activity at screening
  * Severe von Willebrand disease defined as VWF: Act ≤15IU/dL (\<15%) at screening
* Ability of the participant to provide signed and dated informed consent

Exclusion Criteria:

* Contraindication for brain MRI
* HIV infection to avoid a bias towards severe multifactorial neurological complications
* Other known coagulation disorder(s) in addition to haemophilia or von Willebrand disease
* Lack of informed consent
Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male Subjects

This trial is conducted in Europe. The aim of this trial is to investigate the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011 compared to NNC 0128-0000-2021 when given for the first time to healthy human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body weight between 50.0 and 100.0 kg, both inclusive
* Body mass index (BMI) between 18.0 and 28.0 kg/m2, both inclusive

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product or related products, such as activated recombinant factor VII
* Any clinical sign or known history of atherosclerosis or thromboembolic events
* Renal dysfunction
* A subject considered at high risk of thromboembolic events
* Overt bleeding, including from gastrointestinal tract
* Hepatitis B or C infection
* Human immunodeficiency virus (HIV) infection
* Positive test for drugs of abuse or alcohol as well as a history of alcohol or drug abuse within the past 12 months
* Smoking within 3 months prior to trial start
* Unable to abstain from alcohol consumption during visits of trial product administration, visit 2 (0-28 days after screening) and visit 3 (2-4 weeks after visit 2)
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator (trial physician)
* Excessive consumption of a diet deviating from a normal diet
* Blood donation within the last three months prior to screening
* The receipt of any investigational product within 30 days of trial product administration
* Participation in any other trial investigating a procoagulant within the last six months prior to screening
* Strenuous exercise within four days prior trial start
* Suffers from a life threatening disease
* Males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practise).
* Subjects at increased cardiovascular risk, including a strong family history of cardiovascular disease
* Subjects with high fasting cholesterol at trial start
Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis

The rate of fluid removal (ultrafiltration, UF) during hemodialysis (HD) may contribute to cardiovascular morbidity and mortality among individuals receiving maintenance HD. More rapid UF rates are associated with higher morbidity and mortality. Ultrafiltration profiling, the practice of varying UF rates to maximize fluid removal during periods of greatest hydration and plasma oncotic pressures, is one treatment modification that may reduce UF-related harm without necessitating reduction in interdialytic fluid intake or longer HD treatments. To date, UF profiling has not been adequately studied independent of sodium profiling.

This study investigates the comparative effect of UF profiling versus non-profiled conventional HD on select cardiovascular and patient-reported outcomes. Participants will complete two phases of UF profiling and two phases of conventional HD and will act as their own controls.


Eligibility Criteria:
Inclusion Criteria:

* UF rate \>10 mL/h/kg in \>30% of treatments in a 30-day screening period (require ≥6 outpatient HD treatments in this period)
* Age 18-85 years
* Ability to converse comfortably in English or Spanish
* Receipt of in-center maintenance HD at Carolina Dialysis clinics in Carrboro or Siler City, North Carolina
* ≥90 days on HD
* Free of bloodstream infection during screening period
* Willingness to undergo all study testing
* Evidence of a signed and dated informed consent document

Exclusion Criteria:

* Systolic BP unable to be measured by arm cuff
* \>1 hospitalization during screening period
* Unstable angina per treating nephrologist
* End-stage cirrhosis per treating nephrologist
* New York Heart Association class IV heart failure per treating nephrologist
* Pregnant
* More than 4 times per week HD
* Incarcerated
* Anticipated kidney transplant within 6 months per treating nephrologist
* Non-adherence to HD prescription (\>2 unexplained absences during screening period)
* Sodium profiling or UF profiling in standard HD prescription
* Decisionally challenged, unable to provide informed consent
YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma

This is a multicenter, open label, Phase 1/2 study of YH001 initially given in combination with envafolimab, and then given in combination with envafolimab plus doxorubicin in patients with advanced or metastatic sarcoma, followed by Phase 2 cohorts of patients with select histologies of advanced or metastatic sarcoma.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed advanced or metastatic sarcoma patients without UPS or MFS who are refractory to or intolerant to standard treatments for their disease.
2. Histologically confirmed advanced or metastatic sarcoma patients without UPS or MFS who have not received any immune checkpoint inhibitors or doxorubicin, and with histology for which doxorubicin is considered a reasonable treatment option (for Cohort 1B, 2B and Expanded Cohort 1B and/or 2B)
3. Measurable disease by RECIST 1.1
4. Age ≥ 18 years
5. Adequate organ function
6. Left ventricular ejection fraction (LVEF) as measured by echo or multigated acquisition scan of \> 50% (for patients to receive doxorubicin)
7. Willingness and ability to consent for self to participate in study
8. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
9. Men who are sterile or agree to use a condom with spermicide .
10. Women of non-child bearing potential due to surgical sterilization or medically-documented ovarian failure confirmed by medical history, or women of child bearing potential who test negative for pregnancy at time of enrollment and agree to use at least 2 acceptable methods of birth control

Exclusion Criteria:

1. Gastrointestinal stromal tumor (GIST) or desmoid tumors
2. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to enrollment
3. Known allergy to any component of any study drug that the patient would receive if enrolled into this study
4. Prior T-cell or NK-cell therapy
5. Prior pericardial or mediastinal radiation (for patients to receive doxorubicin)
6. Acute coronary syndromes within 6 months of enrollment
7. Women who are pregnant or breast feeding
8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study