cyrilzakka/clinical-trials huggingface dataset:
Screening Protocol for the Evaluation of Research Participants

Background:

- The National Institute on Drug Abuse (NIDA) uses a standardized set of procedures to develop a pool of potential participants for research studies. Because some of the data collected during screening are used later for research, the screening itself is considered a study. An applicant to any NIDA study is considered a participant in NIDA screening.

Objectives:

- To identify, recruit, and screen participants for NIDA research protocols.

Eligibility:

- Individuals 18 years of age and older who are able to provide informed consent.

Design:

* Individuals who are eligible for screening will undergo two interviews: a telephone interview and an in-person interview. The phone interview will determine eligibility for the in-person interview.
* The in-person interview may require up to five visits to NIDA. The in-person visit will involve any or all of the following procedures: (1) full physical examination and medical history; (2) psychiatric interview; (3) psychological testing; (4) electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally invasive procedures as directed by the research staff.
* During screening, a photograph will be taken for confirmation of identity during subsequent visits for other studies.
* No clinical care will be provided as part of screening.

Through its clinical research protocols, the NIDA IRP attempts to: elucidate the nature of drug abuse and addiction; determine the potential use of new therapies, both pharmacological and psychosocial; and decipher the long-term effects of drugs of abuse on the development, maturation, function, and structure of the brain and other organ systems. In support of the IRP's work, the scientific goal of this screening protocol is to assess potential research participants' eligibility for NIDA IRP research studies. Screening will include medical and psychological tests and procedures. The data collected during screening are a unique and valuable source of information that aids in NIDA's mission. Therefore, a secondary goal of this protocol is to obtain data that characterizes the population of subjects contacting NIDA about research participation and to analyze data so obtained, such as that on the prevalence and consequences of HIV/AIDS, viral hepatitis, and related diseases.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Adults (at least age 18)
  2. Ability to understand and answer the questions as posed.

EXCLUSION CRITERIA:

1. Inability to provide valid informed consent.
GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects

The purpose of the study is to evaluate the safety and tolerability of multiple increasing oral doses of GLPG0259 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after multiple increasing oral doses, and potential drug-drug interaction with single dose methotrexate will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse
Mental Health Related to School Dropout in Luxembourg

This study aims to investigate psychosocial risk- and protective factors such as psychiatric disorder, socio-economic background and family functioning among school dropouts and to compare the findings with those by a matched control group of regularly enrolled students.

In Luxembourg, the national authorities had to face school dropout rates of more than 15%. As a result, they introduced accompanying and preventive measures to reduce linguistic and cultural risk factors that may impede educational engagement and vocational decisions. Since 2006, the dropout rate has overall declined. However the proportion of early school leavers who remain without any specific occupation is still alarming.

This study aims to identify psychosocial risk - and protective factors of secondary school dropout in order to deliver solid insight on how to tailor early detection and intervention programs.

In the light of prior findings, the investigators hypothesize that school dropouts have significantly more mental health problems than their peers who go to school. They are also more likely to report a poor socio-economic background, negative school experiences and difficulties in family functioning.

To test those hypotheses, the investigators will have an exploratory case control study.Recruitment of cases will be prospective, from an exhaustive population of dropouts and recruitment of matched controls will be done by random sampling. Data will be collected using self-report questionnaires on mental health, family life and problematic internet use as well as a structured clinical interview to consider psychiatric diagnosis according to the criteria of DSM IV.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in a public secondary school in Luxembourg
* Cases have to be reported as "school dropouts" in the electronic records of the ministry for education
* Informed consent obtained and signed by the adolescent and his/her legal guardian if the participant hasn't reached full age
* Understand German or French, which are the two languages of testing
* Resident in Luxembourg

Exclusion Criteria:

* Acute hospitalization or arrest
Parent-Delivered Massage in Paediatric Cancer

The purpose of this study is to determine how parents of children with cancer rate a parent-delivered massage therapy educational program for usability and satisfaction, and if massage therapy, provided by parents to their child with cancer, reduce symptoms of anxiety and depression in the child, and parenting stress in the parent.

In Canadian children aged 0-19, the number of new cancer cases from 1997-2001 was on average 1,285 children per year for a total of 6,427 children over a five year period. Individual and family responses to a child's or adolescent's cancer diagnosis and treatment include psychological, sociocultural and biological dimensions. Parents of children with cancer can experience severe emotional distress including anxiety and depression. Parents require support and skills to reduce their own anxiety and distress and to help alleviate suffering in their children.

This is a two-phase research project: phase I: development of a standardized educational intervention on video/DVD to teach parents how to massage their child with cancer; phase II: test the feasibility of the developed intervention with children with cancer and their parents. A total of 24 parents and their children with cancer who are under the care of the paediatric oncology units at the Stollery Children's Hospital (Edmonton) will be recruited for the study.

It is hypothesized that this research on an educational program in parent-delivered massage therapy will directly improve the lives of children with cancer and their parents.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 18 years
* Children with a life expectancy of at least 12 weeks
* Children who are currently receiving active cancer care

Exclusion Criteria:

* Children under the age of 6
* Children with a life expectancy of less than 12 weeks
* Children not currently receiving active cancer care
Parecoxib in Total Knee Arthroplasty

Early mobilization and rehabilitation can be difficult after total knee arthroplasty (TKA) due to a high incidence of moderate to severe postoperative pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are important to multimodal analgesic protocols. Parecoxib is an NSAID that selectively inhibits the enzyme cyclooxygenase-2 (COX-2). Clinical trials have shown that it does not alter platelet function or gastric mucosa. A recent study, after comparing ketorolac and parecoxib used at the same time in infiltration and systemically, found no differences in perioperative analgesia with a tendency to less bleeding in the parecoxib group. This randomized study will compare the effectiveness of adding a COX-2 inhibitor in the pain management of patients undergoing TKA as part of a multimodal analgesia regimen. The morphine consumption was selected as the primary outcome. The study hypothesis is that patients receiving parecoxib would have a lower opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

ASA I - III BMI 20 - 35 (kg/m2)

Exclusion Criteria:

* Adults who are not capable of giving their own consent
* Pre-existing neuropathy (assessed in the history and physical examination)
* Coagulation disturbance (assessed on history and physical examination, if clinically necessary, by blood test, i.e. platelets ≤ 100,000, international normalized ratio ≥ 1.4 or prothrombin time ≥ 50)
* Renal failure (assessed by history and physical examination, if considered clinically necessary, by blood test, i.e. creatinine ≥ 1.04 mg/dl)
* Hepatic impairment (assessed by history and physical examination, if considered clinically necessary, by blood tests, i.e. transaminases (GGT ≥ 50 u/lt)
* Allergy to local anesthetics, morphine, paracetamol, ketorolac or parecoxib
* Pregnancy
* Chronic pain syndromes that require the use of opioids at home
* Known history of sulfa allergy
* History of ischemic heart disease
* History of chronic gastritis or peptic ulcer
Observational Familial Adenomatous Polyposis Registry Study In Patients Receiving Celecoxib Compared to Control Patients

This is a registry-based observational study assessing clinical outcomes in FAP patients receiving celecoxib compared with historical/concurrent registry patients who have not received celecoxib.

Both retrospective and prospective data will be utilized. No sampling methods apply.

The study prematurely discontinued on April 11, 2008 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility Criteria:
Inclusion Criteria:

Celecoxib Treated Patients:

* Diagnosis of FAP based on the expression of the FAP phenotype.
* Celecoxib treatment prescribed outside of a clinical trial setting with expected duration of celecoxib treatment of at least six months.

Historical/Concurrent Control Patients:

* Diagnosis of FAP based on the expression of the FAP phenotype.
* Be greater than or equal to 12 years old at the time of study enrollment.
* Have an endoscopically assessable colonic, rectal, ileal pouch and/or gastroduodenal segment.
* For the group of post-surgical patients, IRA or IPAA performed from 1985 onward (in order to assure standardized surgical techniques and post-surgical management). Patients whose primary colorectal surgery was performed prior to 1985 will not be eligible to serve as historical controls.

Exclusion Criteria:

Celecoxib Treated Patients:

* Have received a pharmacological treatment (other than celecoxib) within the last 3 months for their FAP disease including treatment of any extracolonic manifestation of FAP.
* Have received a non-steroidal anti-inflammatory drug (NSAID) within the last 3 months, other than celecoxib, for any reason.

Historical/Concurrent Control Patients:

* Have pharmacological treatment recorded for their FAP disease at the defined index date.
* Have received a non-steroidal anti-inflammatory drug (NSAID) within the last 3 months for any reason.
Comparison of Coagulation Factors During Laparoscopic Cholecystectomy

Pneumoperitoneum is formed with CO2 during laparoscopic abdominal operations. Effect of pneumoperitoneum on coagulation factors is not well known. In our study the investigators aimed to compare the general anesthesia(GA) and combined spinal-epidural anesthesia (CA) during laparoscopic cholecystectomy(LC) with effect on coagulation factors.

Fifty patients will be randomly assigned to either the Laparoscopic cholecystectomy under Combined anaesthesia (25 patients) or Laparoscopic cholecystectomy under general anaesthesia (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder.

Objective of study : The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy(LC).Laparoscopic cholecystectomies are usually performed under general anesthesia. Studies involving cholecystectomies with regional anesthesia recently published. During regional anesthesia pneumoperitoneum is performed with lower pressure(10mmHg CO2). Patients can not tolerate higher intraabdominally pressure. Thera are very few studies involving the effect of pneumoperitoneum on coagulation factors. In our study the investigators separate the patients into 2 groups. Group1:10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia ; Group2 : 10 mmHg pressure, laparoscopic cholecystectomy under Combined Spinal-Epidural Anesthesia The investigators performed standard conventional laparoscopic cholecystectomy procedure with 10mmHg pressure in both groups. The investigators aimed to investigate Prothrombin Time(PT), activated partial thromboplastin time(aPTT), thrombin time(TT), D-dimer and fibrinogen levels preoperative, postoperative 1st hour and 24th hour respectively.

Eligibility Criteria:
Inclusion Criteria:

* Gall bladder stone
* Gall bladder polyp

Exclusion Criteria:

* Pregnancy
* Malignancy
* Children
* Acute cholecystitis
* Vertebral deformities
A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)

The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).


Eligibility Criteria:
Inclusion Criteria:

Subject must have had a diagnosis of primary or secondary warm antibody AIHA.

- Must have failed at least 1 prior treatment regimen for AIHA.

Exclusion Criteria:

* Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria.
* Subject with a platelet count of \< 30,000/μL.
* Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy.
* Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.
Swiss Army Physical Fitness Training

The purpose of this study is to determine whether the new sport concept of the Swiss Armed Forces influences the physical and psychological fitness of the recruits.

The physical and psychological demands in the Swiss Army basic military service are high. Injury incidences in Swiss Army training schools are higher than in armed forces of other countries.There is evidence that progressive loading of physical demands at the beginning of basic military service and specific physical training can reduce injury incidences and attrition rates. A new sport concept by the Swiss Army takes into account these results of previous studies. Therefore, the aim of this study is to investigate the influences of this new sport concept on the physical and psychological fitness as well as on the injury and attrition rates of the recruits.

Eligibility Criteria:
Inclusion Criteria:

* Recruits of the Swiss Army rescue training schools 75 2/2015 and 3/2015

Exclusion Criteria:

* None
Rituximab, Carmustine; Cytarabine, Etoposide, & Melphalan; Stem Cell Transplantation for Non-Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and combination chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy followed by autologous hematopoietic stem cell transplantation in treating patients who have B-cell non-Hodgkin's lymphoma.

OBJECTIVES:

* Determine the levels of soluble CD20 antigen (sCD20) in the blood before and after treatment with rituximab and carmustine, cytarabine, etoposide, and melphalan followed by autologous hematopoietic stem cell transplantation in patients with CD20-positive B-cell non-Hodgkin's lymphoma.
* Correlate the effect of changes in levels of sCD20 with clinical outcomes in patients treated with this regimen.
* Determine the response rate in patients treated with this regimen.
* Determine the event-free survival of patients treated with this regimen.
* Determine the toxicity profile of this regimen in these patients.

OUTLINE: Patients receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks followed 1 week later by hematopoietic stem cell or bone marrow harvest.

Patients then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or -6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6, cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic stem cell transplantation on day 0.

Patients who have less than a complete remission at day 100 post-transplantation receive 4 additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks.

Patients are followed at day 100, at 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-Hodgkin's lymphoma

  o Any B cell
* CD20-positive disease
* Failed prior primary induction therapy
* Meets 1 of the following criteria:

  * Chemotherapy-refractory disease
  * Received at least 3 prior chemotherapy regimens
  * Mantle cell lymphoma
* Eligible for transplantation
* 19 years old and over
* WHO 0-2
* Life expectancy at least 6 months
* Absolute neutrophil count ≥ 1,000/mm\^3\*
* Platelet count \> 50,000/mm\^3\*
* Hemoglobin \> 9.0 g/dL\*

  o NOTE: \*Unless due to lymphomatous involvement of the bone marrow
* Fertile patients must use 2 methods of effective contraception

Exclusion Criteria:

* No history of T-cell lymphoma
* Not pregnant or nursing
* No other concurrent serious disease or condition that would preclude study participation
Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome

The main purpose of this study is to assess the efficacy of metformin in abrogating androgen deprivation therapy (ADT) induced insulin resistance as measured by homeostasis model assessment (HOMAIR) in men with non-metastatic prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* ECOG ≤ 1
* Histologically confirmed prostate cancer of early or locally advanced stage, or metastatic prostate cancer with bone involvement only (≤ 5 sites of bone metastases only)
* Plan to receive ≥ 6 months continuous androgen deprivation therapy by a GnRH agonist
* Patients who are to receive antiandrogens with GnRH agonists are not excluded from the study. But the form, dose and duration of antiandrogen treatment should be recorded.
* Adequate renal function (Creatinine ≤ 177mMol/L and GFR \>30 mls/min )
* Adequate hepatic function (Bilirubin must be ≤ 1.5 x upper limit of normal range, ALT and ALP must be ≤ 2.5 x upper limit of normal)

Exclusion Criteria:

* Visceral involvement
* \> 5 sites of bone metastases
* History of confirmed diabetes mellitus (patients with impaired fasting glucose or impaired glucose intolerance will not be excluded) 12
* Treatment with medications that may alter glucose or insulin level within 3 months (including insulin, oral hypoglycemic agents, systemic corticosteroid of any dosage, atypical antipsychotic drugs of any dose)
* Malignant disease other than prostate cancer at the time of enrolment
* Bilateral orchiectomy
* Previous androgen deprivation therapy by a GnRH agonist or anti-androgen within last 12 months(patient who had a GnRH agonist more than 12 months ago are allowed if their testosterone levels are in the normal range at the time of recruitment)
* Chemotherapy within 6 months
* History of lactic acidosis
* Cardiac or respiratory insufficiency, severe infection that is likely to increase the risk of lactic acidosis
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent
Mother and Child Education Program in Palestinian Refugee Camps

The purpose of the Mother Child Education Program (MOCEP)-a group-based early childhood development parenting education program-is to provide school-readiness and parenting skills to mothers of young children who do not have access to preschool education services. The MOCEP intervention also provides a setting in which caregivers can model pro-social behaviors and practice conflict resolution techniques directly with young children.

The purpose of the evaluation study is to rigorously evaluate the impact of MOCEP on child and parent outcomes among Palestinian refugees in Beirut, Lebanon. This evaluation employs an innovative, mixed-methods bio-behavioral approach to investigate the associations among social contexts; maternal, child and family functioning; and reduction in violence through the promotion of harmonious family relationships. The results of this study have implications for improving the lives of and reducing violence for the hundreds of thousands of families with young children living in fragile contexts. We hypothesize that when MOCEP is implemented with fidelity (i.e., delivered as intended by design), participating families will experience reduced violence in their homes and have better individual and intra-family outcomes than families who do not participate in the program.

Eligibility Criteria:
Inclusion Criteria:

1. Child must be between 3 and 6 years of age (children age 7 may be accepted under special circumstances)
2. Mother must be able to read and write in Arabic (although skills may not be well-developed)
3. Mothers must commit to participate in the 25-week MOCEP Intervention program
Impact of Balanced Slat Colloid HES 130/0.42 on Coagulation Profiles in Patients Undergoing Spinal Cord Tumor Surgery

The purpose of study is to compare the effect of coagulation profile in patients receiving intraoperative balanced salt colloid undergoing spinal cord tumor surgery.


Eligibility Criteria:
Inclusion Criteria:

* adult patients over the age of 20 scheduled for spinal tumor removal and fixation

Exclusion Criteria:

* 1. Renal failure 2. Preexisting congestive heart failure(NYHA III \~ IV) 3. Anemia 4. Coagulopathy 5. Abnormal liver function 6. Anti coagulation/Anti platelet ,edication 7. Foreigner, illiterate 8. Disabled person,
Understanding Immunity to the COVID-19 Vaccines

The purpose of this study is to test over time immunity to the COVID-19 vaccines. Adults who are receiving COVID-19 vaccines will be invited to participate.


Eligibility Criteria:
Inclusion Criteria:

* Adults who are receiving a COVID-19 vaccine

Exclusion Criteria:

* Patients with special risks attendant to venipuncture