cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid \[mRNA\]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.


Eligibility Criteria:
Inclusion Criteria:

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

* Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma
* Has not received any prior systemic therapy for their melanoma beyond surgical resection
* No more than 13 weeks have passed between final surgical resection that rendered the participant disease-free and the first dose of pembrolizumab
* Is disease free at the time of providing documented consent for the study
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)

Exclusion Criteria:

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

* Has ocular or mucosal melanoma
* Has cancer that has spread to other parts of the body and cannot be removed with surgery
* Has heart failure within the past 6 months
* Has received prior cancer therapy or another cancer vaccine
* Has another known cancer that that has spread to other parts of the body or has required treatment within the past 3 years
* Has severe reaction to study medications or any of their substance used to prepare a drug
* Have not recovered from major surgery or have ongoing surgical complications
Impact of Nutritional Supplementation on Sleep Quality

This is a randomized, double-blind, placebo-controlled, 5-arm parallel-group study to evaluate the effects of 4 nutritional supplements on sleep over a 12 week period in healthy U.S. adults.


Eligibility Criteria:
Inclusion Criteria:

1. Be able to give written informed consent.
2. Be between 18-65 years of age (inclusive).
3. Insomnia severity Index score ≤14.
4. PROMIS Sleep Disturbance Questionnaire raw score ≥23
5. Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
6. Willing to consume the study product daily for the duration of the study.

Exclusion Criteria:

1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
2. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception as determined by the investigator.
3. Has a history of drug and/or alcohol abuse.
4. Hypersensitive to the contents of the study product.
5. Participants with work schedules that result in irregular sleep patterns/ or have night-shift employment.
6. High caffeine intake, \>400mg/day.
7. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history. Excluded health conditions include:

   1. Diagnosed Sleep disorders
   2. Major psychiatric diagnosis (e.g., bipolar), as diagnosed by a healthcare professional, including major depressive disorder (e.g., clinical depression)
   3. Immunocompromised health conditions
8. Currently or recently (in the past 4 weeks) taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:

   1. Prescribed sleep medications
   2. Prescribed Medications which impact sleep, including but not limited to sedative hypnotics, anxiolytics, and antidepressants.
9. Current or recent (in the past 4 weeks) use of prohibited nutritional and non-nutritional supplements with known or possible sleep effects (e.g. valerian, multivitamins, melatonin)
10. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
11. Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
Diameter Changes of Retinal Vessels During Hypoxia

The primary objective is to study if an inhibition of nitric oxide and/or prostaglandins affect the diameter changes of retinal vessels observed during hypoxia. Diameter changes are studied using the Dynamic Vessel Analyzer.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes type 1 without retinopathy
* Diabetic retinopathy

Exclusion Criteria:

* Cardio-vascular disease
* Lung disease
* Pregnancy
* Previous ocular disease other than retinal branch vein occlusion
* Previous treatment with medications influencing on the intraocular pressure or the metabolism of nitric oxide or prostaglandins
A Clinical Trial of the Transcendental Meditation (TM) Program on Blood Pressure, Psychological Distress, and Coping

The purpose of this trial is to show that the Transcendental Meditation program can decrease blood pressure in young adults (college students) and is associated with decreased psychological distress and coping ability.

Psychological distress contributes to the development of hypertension in young adults. This was a randomized controlled trial of 296 university students randomly allocated to either the Transcendental Meditation® program or wait-list control. At baseline and after three months posttest, systolic and diastolic blood pressure, psychological distress (total mood disturbance, anxiety, depression, anger/hostility) and coping ability (global constructive thinking) were measured.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* currently enrolled in an undergraduate or graduate program through August 2006

Exclusion Criteria:

* history of:

  * hypertension
  * hypoglycemia
  * chronic fainting
  * coronary heart disease
  * current systolic/diastolic blood pressure above 140/90 mm Hg or below 90/60 mm Hg
An App-based Versus a Web-based Self-management Intervention or Usual Care in People With Low Back and/or Neck Pain on a Waiting List for Hospital-based Outpatient Rehabilitation

The purpose of this study is to evaluate the effectiveness of an individually tailored self-management intervention, the selfBACK app, in improving health status in patients on a waiting list for outpatient rehabilitation due to low back and/or neck pain compared to a non-tailored web-based self-management solution (e-Help) and usual care only.

Patients on waiting list for treatment at the multidisciplinary outpatient clinic for back, neck and shoulder rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway, due to low back and/or neck pain are the target group for this study. The average waiting time for receiving treatment is 8-10 weeks. The use of digital solutions can be a beneficial approach to support self-management during the waiting period. Therefore, the effectiveness of these tools in this patients group needs to be evaluated.

A total of 279 participants will be recruited and randomly allocated to one of the three groups: 1) the selfBACK app in addition to usual care; 2) the e-Help webpage in addition to usual care; and 3) usual care only. Participants who receive either the selfBACK app and the e-Help webpage will be allowed to seek care, treatment or help elsewhere as usual.

Self-reported outcome measures will be collected through web-based questionnaires at three follow-up time points: 1) 6 weeks; 2) 3 months (primary endpoint); and 3) 6 months. In addition, participants receiving the selfBACK app will be asked a set of weekly tailoring questions to individualize self-management plans. Objective registry based data linked to social security number in Norway will be used to investigate health care consumption and sickness absence at 1 year (and up to 5 years).

Eligibility Criteria:
Inclusion Criteria:

* On waiting list for treatment at the multidisciplinary outpatient clinic for back, neck and shoulder rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway due to low back pain and/or neck pain
* Own and use a smartphone with internet access to download the mobile application
* Able to provide informed consent

Exclusion Criteria:

* Less than 4 weeks waiting time until scheduled appointment at clinic (i.e., patients prioritized for urgent treatment/examination)
* Unable to take part in exercise/physical activity, e.g. non-ambulatory patients, use of walking aids, unable to get up and down the floor independently
* Unable to speak and/or read Norwegian
* Unable to complete the baseline questionnaire
Remote Food Photography Method in Infants

The purpose of this study is to determine if digital photography on a Smartphone and the Remote Food Photography Method (RFPM) can estimate infant formula intake. This is a validation study; there is no hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Willing to complete 2 study visits at Pennington Biomedical (PBRC)
Ridge Preservation Using Guided Regenaration, Platelet-rich Plasma and Free Gingival Grafts

The goal of this clinical trial is to learn if ridge preservation methods with dense polytetrafluoroethylene membranes, with d-PTFE membranes and platelet-rich plasma, and with free gingival grafts can reduce vertical resorption of the post-extraction socket walls.

Researchers compared each experimental group to a control group (unassisted socket healing). Participants were randomly allocated to one of the four groups.

Cone-beam computed tomography was performed after the procedure and 3 months post-operatively to evaluate the vertical socket wall resorption.


Eligibility Criteria:
Inclusion Criteria:

1. Patients in the age group 18-65 years;
2. Patients in good general condition;
3. Patients requiring extraction of premolars or molars;
4. Patients in whom restoration of the missing tooth with a dental implant and/or prosthetic construction is planned;
5. Signed informed consent to participate in the study.

Exclusion Criteria:

1. Patients with contraindications for general surgical treatment:

   * patients with uncontrolled arterial hypertension;
   * patients with uncontrolled metabolic diseases;
   * patients with AMI in the last 6 months;
   * patients on hemodialysis treatment;
   * patients who underwent chemotherapy and/or radiotherapy in the last year;
   * patients on immunosuppressive therapy;
   * patients on anti-resorptive and anti-angiogenic therapy;
   * patients with concomitant acute diseases at the time of the study;
   * patients with proven psychiatric diseases;
   * pregnancy.
2. There are local contraindications:

   * insufficient volume of bone after the extraction to carry out RP;
   * acute inflammatory disease or tumor process in the area;
3. Lack of informed consent.
4. Lack of patient motivation for the treatment.
Clinical Risk Score Predicting the Cardiac Rupture in Patients With ST-elevation Myocardial Infarction

The purpose of this study is to validate a practical risk score to predict the mechanical complication of ST-elevation myocardial infarction (STEMI).

STEMI patients chewed 300 mg aspirin and 600 mg clopidogrel in the emergency department, followed by oral 100 mg aspirin and 75mg clopidogrel daily for at least 12 months. STEMI patients received low molecular weight heparin (LMWH), β-blockers, and angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) according to the STEMI guideline, unless there were contraindications to these drugs. Peripheral blood samples were collected from patients within 2 hours of admission for blood routines and blood biochemistry examinations. White blood cell counts and level of hemoglobin were assessed with automated cell counters via standard techniques. The investigators followed up patients in validation group for three month to observe the cardiac rupture events and other adverse cardiac events .

Eligibility Criteria:
Inclusion Criteria:

ST-elevation myocardial infarction: concurrence of symptoms (chest pain or symptoms compatible with acute heart failure or unexplained syncope) and electrocardiogram findings (new onset left bundle branch block or ST-segment elevation≥1 mm in ≥2 inferior leads or ≥2 mm in ≥2 precordial leads)

Exclusion Criteria:

cancer mental illness
Feasibility and Pilot Testing of Group-based ACT for Adolescents With Functional Somatic Syndromes

Recurrent and impairing functional somatic syndromes (FSS) are common in adolescents. Despite a high need for care, empirically supported treatments are lacking for youth. The aim of the uncontrolled was to assess feasibility and treatment potential of group-based Acceptance and Commitment Therapy (ACT) in a generic treatment approach for adolescents with multiple FSS i.e. "ACT for Health in Adolescents" (AHEAD).


Eligibility Criteria:
Inclusion Criteria:

* Bodily Distress Syndrome, multi-organ type of at least 12 months' duration
* Raised since early childhood in Denmark or born by Danish parents
* Understand, speak and read Danish
* Moderate or severe impairment

Exclusion Criteria:

* Acute psychiatric disorder demanding other treatment, or if the patient is suicidal.
* A lifetime diagnosis of psychosis, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.2, F33.3), serious cognitive deficits or developmental disorders such as mental retardation and autism (ICD-10: F70, F84)
* Substance abuse of e.g. narcotics, alcohol or medication.
* Pregnancy at time of inclusion
* Not able to participate in group-based treatment, e.g. patients with severe ADHD (ICD-10: F90), severe social phobia (ICD-10: F40.1) or conduct disorder (ICD-10: F91)
LEAN Project: Weight Loss and Appetite Suppression

The primary aim is to examine whether the intake of PhosphoLEAN is effective in aiding a cohort of women in losing weight. Participants taking the supplement will have significantly greater improvement in study outcomes than those taking the placebo.

Participants will be randomized to either a control or treatment group taking the dietary supplement containing a soy lecithin-derived N-oleoyl-phosphatidyl-ethanolamine (NOPE) and caffeine free Green Tea-derived epigallocathchin gallate (EGCG) whose trade name is PhosphoLean. The outcome is to determine the effects on indices of weight loss and appetite suppression. Participants will return at 6, 12, and 16 weeks for clinical measures.

Eligibility Criteria:
Inclusion Criteria:

* 30-45 years, women, overweight or obese class I, premenopausal, maintain current diet and exercise regimen

Exclusion Criteria:

* pregnant or planning to become pregnant, currently have or history of cancer, heart disease, anemia, diabetes, depression
Effect of Home Health Case Management on Asthma Morbidity

The objective of our program is to evaluate the effect of home health nurse intervention and education on hospital admissions, ER utilization and asthma control of Passport asthma patients. The investigators hypothesize that case management and in home education by nurses will decrease hospitalizations and ER asthma visits and improves disease control in our population.

Our clinic population consists of primarily inner-city, low income, medicaid recipients. This population suffers from severe asthma much more than the typical pediatric population. Asthma remains the most frequent cause of hospital admission for our patient population. Home health nurse asthma education and home visits have been reported to reduce asthma triggers in the home and improve asthma control. The unique partnership between the pediatrician and the home health nurse will give us a better understanding of the health needs for this population, will improve quality of care and deliver more cost effective care.

Asthma patients age 3-17 enrolled in our clinic who have been seen in the ER, hospital or clinic for an asthma exacerbation will be invited to participate. Once enrolled they will have a home health nurse visit their home and provide medical assessment, asthma education and determine if the patients has all needed medications available. They enrolled patient will receive another home visit at 1, 4, and 12 months after enrollment. The medical record will be reviewed and ER visits and hospitalizations recorded.

Eligibility Criteria:
Inclusion Criteria:

* Children age 3-17 years with asthma who attend our clinic who present with an asthma exacerbation to the clinic, ER or hospital.

Exclusion Criteria:

* Patients with airway anomalies or tracheostomy
Copeptin as a Stress Marker During a Written Examination

To investigate whether copeptin levels increase upon a psychological stress (i.e. written examination) and whether copeptin levels measured immediately before the written examination predict success of the examination.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Member of 4th year in medical course at Basel University

Exclusion Criteria:

* Intake of any medication (except birth control pill)
* BMI over 30kg/m2
* Evidence of acute disease
* History of chronic illness, including chronic psychiatric disease
* Anamnestic certain or assumed pregnancy
* Regularly smoking students
A Pilot Study to Assess the Immunogenicity of Candidate PSA Peptides for a Prostate Cancer Vaccine

To measure antigen-specific interferon-secretion by enzyme-linked immunospot (ELISPOT) assay, which measures antigen-specific interferon-secretion.

The goal of this project is to collect information in regards to the immunogenicity of PSA peptides in order to develop a novel therapeutic vaccine. This vaccine will consist of prostate specific antigen (PSA) peptide and Candida skin test reagent. Candida has recently been shown to be a promising new vaccine adjuvant for promoting T-cell responses. It can induce interleukin-12 (promotes T-cell response) secretion by Langerhans cells, the main antigen presenting cells in skin. In a Phase I clinical trial treating women with biopsy-proven high-grade squamous intraepithelial lesions (HSILs), precursors of cervical cancer, a combination of human papillomavirus peptides with Candida was demonstrated to be safe, to induce immune responses to human papillomavirus, and to promote T-helper type 1 (Th-1) response (promotes cellmediated immunity) in vaccine recipients.

For treating prostate cancer, PSA is an ideal antigen as it is expressed in prostate cancer but not in any other organs. The characteristics of peptides that can effectively be used in therapeutic vaccines are their solubility in a single solution, immunogenicity in terms of containing large number of T-cell epitopes (so the vaccine can be used for all patients and not just a few that express certain Human Leukocyte Antigen (HLA) tissue types), and ability to mature Langerhans cells which in turn promotes T-cell activity.

In this protocol the investigators focus on the immunogenicity of candidate peptides.

Eligibility Criteria:
Inclusion Criteria:

* Histological documented diagnosis of prostate cancer
* 18 years of age or older
* Signed informed consent form approved by the University of Arkansas for Medical Sciences (UAMS) Institutional Review Board (IRB)

Exclusion Criteria:

* Subjects must have no other current malignancies.
* Subjects with prior history at any time of any basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration.
* Subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration
Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms

Phase 3, randomized prospective study, double blind-double placebo, testing oral therapies APREPITANT versus HYDROXYZINE in patients followed for myeloproliferative neoplasms and suffering of persistent aquagenic pruritus.

Identification of patients with myeloproliferative neoplasms and aquagenic pruritus. Evaluation of the intensity of the aquagenic pruritus. Patients with value \>5/10 on the VAS (Visual Analogue Scale ) are proposed to participate to the protocole. Randomization between the two treatments. Duration of the treatment : 14 days. Regular evaluation of efficacity of the drugs (questionnaires). Evaluations will stop 2 months after the last intake. Blood samples will be collected before and after the intakes to study cytokine and neuropeptide levels.

Eligibility Criteria:
Inclusion Criteria:

* Major patients with myeloproliferative neoplasms (polycythemia vera, essential thrombocythaemia or myelofibrosis)
* and treated with hydroxyurea, pipobroman, anagrelide, α2a pegylated interferon, ruxolitinib or bled for more than 6 months
* and suffering of persistent aquagenic pruritus
* and with a pruritus intensity on Analogic Visual Scale \>5/10
* patients who gave their written consent for participation in the study

Exclusion Criteria:

* patients with a physical or psychological disability to sign the consent form
* patients with myeloproliferative neoplasms and suffering of aquagenic pruritus but only treated by aspirin
* patients already included in another therapeutic protocol
* patients with diffuse dermatological disease where pruritus may be present (psoriasis, atopic dermatitis, prurigo
* patients already on anti-anxiety and / or anti-depressant treatment
* patients with absolute contraindications to the use of Aprepitant or Hydroxyzine
* hypersensitivity to Aprepitant and / or Hydroxyzine or to any of their excipients
* lactose intolerance
* pregnant or lactating women
Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma:

Utilization data will be collected from all patients entered on the trial at Canadian centres from the time of registration until death, removal from study, or completion of 10 years of follow-up.

Protocol-specified health care utilization will be collected within trial case report forms, and will include study visits, radiographic assessments, laboratory investigations, and treatment administration.

Resource utilization data collection will be supplemented by a self-administered resource utilization form (Stanford SMRC) to document non-protocol specified utilization. This will include hospitalizations (including days in hospital), emergency room visits, and non-protocol specified ambulatory visits.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be eligible for the core CLC3/S1925 protocol.
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
* Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English or French. The baseline assessment must be completed within required timelines, prior to enrollment. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.
* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.