cyrilzakka/clinical-trials huggingface dataset:
Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Crohn's Disease Patients

Patients with crohn's disease often suffer significant limitations to their quality of life, which are also conditioned by particular stress and psychosocial accompanying symptoms of the disease. A multimodal program for stress-reduction and lifestyle-modification has been shown to be effective in promoting the quality of life in patients with uncreative colitis. The study will examine the promotion of the quality of life of patients with crohn's disease and the positive Influence on stress, psychological symptoms and physiological parameters.

40 patients with ulcerative colitis will be randomized in an Intervention group and a control group for 10 weeks. The primary outcome is the feasibility of the study, the intervention and the examinations. The Secondary outcomes are disease-specific quality of life, disease-activity, stress, psychological symptoms, inflammatory parameters, disease activity parameters, bowel parameter and the microbiome. As qualitative parameters, the influence of the disease on everyday life and the experience/ impact/ implementability of the programme will be investigated. Lastly, undesirable events will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 75 years
* Presence of a confirmed diagnosis of Crohn's disease
* In remission (not longer than 12 months, or mild to moderate clinical activity (HBI \< 16)
* Medication that has been stable for at least 3 months, regardless of whether glucocorticoids, immunosuppressive drugs, azathioprine, or other drug treatments according to MBMCrohn - Version 1.0 from 06.12.2019 Page 7 Guideline
* Signed declaration of consent

Exclusion Criteria:

* infectious or refractory Crohn's disease with severe course
* Complete colectomy
* Severe psychological illness (e.g. depression requiring treatment, addiction, schizophrenia)
* Severe comorbid somatic disease (e.g. diabetes mellitus, oncological disease)
* Pregnancy
* Participation in stress reduction programmes or clinical studies on psychological interventions
A Drug Interaction Study of Boceprevir in Combination With Amlodipine or Diltiazem in Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetic interactions between the hepatitis C NS3 protease inhibitor boceprevir and the calcium channel blockers amlodipine and diltiazem in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to sign informed consent prior to any study-related activities.
2. Male or female subjects between 18 and 65 years of age inclusive.
3. Healthy, i.e. not suffering from a relevant acute or chronic illness.
4. Body Mass Index (BMI) of 17.5 to 31 kg/m2; and a total body weight \> 50 kg (110 lbs).
5. Acceptable medical history, physical examination, and 12-lead ECG at screening.
6. Acceptable laboratory values that indicate adequate baseline organ function at screening visit.
7. Willing to stop using any herbal or natural health products for 2 weeks prior to and during the study including: Grapefruit, grapefruit juice, St. John's Wort.
8. Willingness to abstain from alcohol use for 3 days prior to and during the study.
9. Female subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:

   * Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
   * A vasectomized partner
   * Total abstinence from sexual intercourse

Exclusion Criteria:

1. Have serological evidence of exposure to HIV or HCV.
2. Known allergies to any of the study medications.
3. Female subjects of childbearing potential who:

   * Has a positive urine pregnancy test at screening.
   * Is not willing to use a reliable method of barrier contraception during the study.
   * Using only oral contraceptive as a birth control method.
   * Is breastfeeding.
4. Inability to adhere to protocol.
5. Use of any medications (2 weeks prior to or during the study) other than occasional use of acetaminophen.
6. Female subjects using contraceptives that contain drospirenone.
7. Subjects that are currently smoking.
8. Subjects with hypertension or heart disease requiring medical treatment.
9. Any condition possibly affecting drug absorption (e.g., gastro intestinal disorder).
10. Patients may be excluded from the study for other reasons, at the investigator's discretion.
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 in Healthy Males

Phase 1 study in healthy subjects to determine the effect of an 8-hour fast from food on the pharmacokinetics of \[14C\]-BGB-3111.

This study will be an open-label, non-randomized study to evaluate the pharmacokinetics of \[14C\]-BGB-3111 when administered in healthy male subjects following at least an 8-hour fast from food (not including water).

Eligibility Criteria:
Inclusion Criteria:

1. Male between 18 and 65 years of age, inclusive, at Screening
2. Body mass index between 18.0 and 35.0 kg/m2, inclusive, at Screening
3. In good health, determined by no clinically significant findings from medical history,12-lead ECGs, or vital signs measurements
4. Clinical laboratory evaluations

Exclusion Criteria:

1. Significant history or clinical manifestation of any metabolic, allergic, infectious, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator \[or designee\]) prior to Check-in
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) prior to Check-in
3. History of stomach or intestinal surgery or resection that could alter absorption or excretion of orally administered drugs prior to Check-in except that appendectomy and hernia repair will be allowed if it was not associated with complications
4. Abnormal liver function tests
A Multi-center, Multi-regional Observational Study to Test the Responsiveness of the Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument to EDSS Status Changes in Any Form of Multiple Sclerosis (MS) in Patients With or Without Treatment

This is a multi-center, multi-regional observational,24 month study.

Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.

This is a multi-center, multi-regional observational,24 month study.

Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has any form of MS (confirmed by McDonald and/or Poser criteria)
2. Patient is 18 years old or more (inclusive, at time of informed consent).
3. Patient has an EDSS score lower than 7.0 (inclusive, at time of informed consent)
4. Patient can be with or without treatment
5. Patient has read, understood, signed and dated informed consent form
6. Patient is able to fill in the questionnaire by him/herself

Exclusion Criteria:

1. CIS Patient (MS not confirmed by Mc Donald and /or Poser criteria)
2. Patient receives or is planned to receive during the course of this study any investigational drug or experimental procedure
3. Patient suffers from dementia in the opinion of the investigator
4. Patient suffers of major medical or psychiatric illness in the opinion of the investigator
A Study to Determine the Efficiency For Brain Metastasis NSCLC Patients Treated With Icotinib Alone or Combined With Radiation Therapy

The purpose of this study is to evaluate the efficacy of icotinib alone or in combination with radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. The primary endpoint is overall survival .

Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases, and most patients died due to the progression of brain metastases. Some research show that icotinib combined with radiation therapy can improve the efficiency of NSCLC with brain metastases, but there is still controversial about the timing of radiation therapy intervention . This study is a prospective, multi-center, randomized, controlled trial of icotinib combined with early intervention or late intervention radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. They will be treated with icotinib and divided into 2 groups. Group 1: the radiation therapy will start within 1 month after icotinib treatment; Group2: the patients will be treated with icotinib first, radiation therapy intervene if disease progress.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of non-small-cell lung cancer (NSCLC)
* Positive EGFR mutation（Ex19del or 21L858R）
* Primary diagnosis of brain metastases
* Have one or more measurable encephalic lesions according to RECIST
* Extracranial transfer organ≤3
* ECGO:0-2
* Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.
* Adequate renal function: Serum creatinine ≤1.5 x ULN, or ≥ 50 ml/min.
* Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and -Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases.
* Female subjects should not be pregnant.
* All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
* Written informed consent provided.

Exclusion Criteria:

* Previous usage of EGFR-TKI : gefitinib, erlotinib, icotinib，or any other TKI
* CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
* Allergic to Icotinib.
* Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
* Pregnancy or breast-feeding women.
* Participate in the other anti-tumor clinical trials in 4 weeks. have quit from the trail before.
* Any other serious underlying medical, psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
Determining the Impact of a Physiotherapist-Led Primary Care Model for Hip and Knee Pain - A Pilot Trial

This is a pilot cluster randomized controlled trial to to evaluate the individual and health system impacts of implementing a new physiotherapist-led primary care model for hip and knee pain in Canada.

Arthritis is one of the leading causes of pain, disability, and reduced quality of life in patients. Arthritis currently affects one in five Canadians (six million), which is expected to rise to nine million people by 2040. Osteoarthritis (OA) is the most common forms of arthritis, with hip and knee being two of the most common locations.

For most people, the first point of contact for their pain is their primary care provider. Due to the rise in patients seeking support at the primary care level, the shortage of primary care providers, and the high burden on these providers, patients often do not receive timely access to the care they require. A promising strategy is to have an integrated model of care where a physiotherapist (PT) is the first point of contact within interprofessional primary care teams. PTs can provide a comprehensive and efficient management strategy for patients presenting to their primary care provider with hip and knee pain complaints.

This study aims to determine the feasibility of conducting a cluster randomized trial in primary care settings in Ontario to evaluate the individual health outcomes and health system impact of implementing a new physiotherapist-led primary care model for people with hip and knee pain.

The primary objectives of this pilot study are:

1. Determine the feasibility of participant recruitment, assessment procedures, and retention.
2. Determine the feasibility of implementing a new PT led primary care model for hip and knee pain.
3. Explore the perspectives of patient participants and HCPs related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value and impact on clinic processes and patient participant outcomes.

Eligibility Criteria:
Inclusion Criteria:

- Adults \>= 19 years who ask to book a primary care visits where the primary reason is for hip or knee pain of any duration.

Exclusion Criteria:

* Cannot understand, read, and write English
* Known cancer causing hip or knee pain
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The study consists of a 28-week double blind, placebo-controlled period, followed by 24 weeks of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 14 months for the core study and will be a variable amount of time per participant for the OLE (estimated to be approximately 3 years).


Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to adhere to the study procedures, including all requirements at the study center, and return for the follow-up visit.
* Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency.
* Be on a stable steroid regimen.
* Have elevated androgen levels.
* Participants of childbearing potential must be abstinent or agree to use appropriate birth control during the study.

Exclusion Criteria:

* Have a diagnosis of any of the other forms of classic CAH.
* Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.
* Have a clinically significant unstable medical condition or chronic disease other than CAH.
* Have a history of cancer unless considered to be cured.
* Have a known history of clinically significant arrhythmia or abnormalities on electrocardiogram (ECG).
* Have a known hypersensitivity to any corticotropin-releasing hormone antagonist.
* Have received an investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study.
* Have current substance dependence or substance (drug) or alcohol abuse.
* Have had a significant blood loss or donated blood or blood products within 8 weeks prior to the study.
Korean Coronary Bifurcation Stenting (COBIS) Registry III

The COBIS III registry is a multi-center, real-world registry of 2nd generation drug-eluting stenting in coronary bifurcation lesions in South Korea. From 21 major coronary intervention centers in Korea, a total of 3,000 patients (anticipated) will be enrolled in this database between January 2010 and December 2014.

The aim of the study was to investigate long-term clinical results and predictors of adverse outcomes after percutaneous coronary intervention with 2nd generation drug-eluting stents for coronary bifurcation lesions in South Korea.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=19 years
* Any type of de novo bifurcation lesion in major epicardial artery: unprotected left main coronary bifurcation lesion, LAD - diagonal, LCX-OM, distal RCA bifurcation. (Excluding RCA-RV branch bifurcation, branch bifurcation)
* Side branch or LCX reference diameter \>= 2.3 mm and at least stentable with 2.5 mm stent
* Treated with drug-eluting stent during the period of 2010. 1 \~ 2014. 12

Exclusion Criteria:

* Protected left main disease previous CABG for LAD or LCX territory
* Cardiogenic Shock
* History of CPR in the same hospitalization
* Patients with severe left ventricular systolic dysfunction (ejection fraction \< 30%)
From Compliance to Alliance: Engaging Psychiatric Patients in Illness Management

The purpose of this study is to determine the benefit and impact on relapse prevention,adherence to treatment and general health indices of participation in psycho-eduational group intervention among psychiatric patients with severe mental illness,recently discharged from inpatient services.

Medication non-compliance, estimated to affect 50% of all psychiatric patients, was shown to be strongly associated with an elevated risk for relapse, readmission to psychiatric inpatient care, longer length of stay and suicide, resulting in elevated costs across the health care system. The proposed project seeks to bridge the gap between the significant progress of recent years in psycho-pharmacology that produced more efficient 'newer generation' medications, and the continuing unanswered problem of non-compliance, by applying knowledge from clinical decision-making theories and recent evidence-based research on the management of severe mental illness.

In Phase I of the project, an epidemiological survey will be conducted to evaluate the magnitude and correlates of the problem in patients attending walk-in crisis clinic , using Treatment Compliance Assessment and Decision-Making Assessment Tools, both developed by the researchers. An 8-module psycho-educational intervention protocol emphasizing illness management and optimization of health care decision-making will then be designed and implemented.

In Phase II, eligible outpatient clients will be randomly assigned to either Intervention or Standard Care conditions, and followed for a period of 15 months. Repeated assessments will include pre-post measures of knowledge, treatment compliance, and decision-making, and on outcome measures of relapse such as hospitalizations and symptoms, functioning, self-efficacy, quality of life, and satisfaction with services.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of severe mental illness, younger than 70 years of age, recently discharged from psychiatric inpatient services at the Rambam Medical Health Center.

Exclusion Criteria:

Diagnoses other than schizophrenia, major depression and bipolar disorders; 70 + years of age; organic problems
Identification of the Most Suitable Questionnaire to Assess the Sexual Function of Women Living in France After Colorectal Cancer Surgery

Sexual quality of life is rarely mentioned by physicians during follow-up consultations, even though it is the source of a significant deterioration in quality of life (QOL).

The assessment of female sexual function is based on self-administered questionnaires. Four questionnaires have been translated and validated in French: FSFI, PISQ-IR, PISQ-12, BISF.

The objective of this project is to determine which questionnaire is acceptable and adapted to a cohort of women living in France who have undergone treatment for rectal cancer

Quality of life (QoL) is often impaired in the aftermath of rectal cancer management due to impaired rectal function and the impact of surgery and radiation therapy on pelvic innervation and the genitourinary sphere. Female sexual function is rarely mentioned by caregivers during follow-up consultations, even though it is a source of significant alteration in the quality of life. Assessment of sexual function is based on self-assessment questionnaires. Most of them were written in English and correspond to the Anglo-Saxon culture. Four questionnaires were translated and validated in French: FSFI, PISQ-IR, PISQ-12, BISF. Two are general sexual HRQOL questionnaires, 2 are sexual HRQOL questionnaires developed for women with genitourinary prolapse.

The identification of the acceptable questionnaire adapted to women living in France will be done through a randomized double-blind study. The duration of patient participation will be 6 months, corresponding to the period of inclusion, collection of informed consent, sending of the questionnaire bundles and collection of the bundles.

Eligibility Criteria:
Inclusion Criteria:

* female
* over 18 years of age
* who have signed the informed consent to participate in the study
* having had rectal or recto-sigmoid cancer at least one year before, whatever the stage, treated by rectal or recto-sigmoid resection with sphincter preservation
* in the course of an eventual adjuvant treatment (chemotherapy or radiotherapy)
* affiliated to the social security system of the health insurance, whatever the system

Exclusion Criteria:

* colon cancer
* pelvic radiotherapy for a pathology other than colorectal cancer
* rectal resection without restoration of continuity (Hartmann or abdominal-perineal amputation)
* peritoneal carcinosis
* colorectal resection for benign lesion
* Inflammatory bowel disease (IBD)
* emergency surgery
Project MILANO: Connections Between Patients With Brain Tumors and Their Pets: an Analysis of Concerns and Needs

Context and problem

In France, 61% of households own a pet, highlighting the significant role pets play in the daily lives. Patients diagnosed with brain tumors face specific challenges that may affect their ability to care their pets, including:

* Progressive neurological deficits (cognitive and/or motor), limiting their autonomy,
* A life-threatening prognosis.

In this context, the well-being of pets when their owner's health deteriorates becomes a critical concern. Indeed:

* Social isolation and the progressive loss of physical and cognitive abilities complicate pet care, particularly during prolonged hospitalizations or in the event of death,
* The lack of appropriate facilities and care solutions causes stress for pets, who are often unprepared for such transitions, and adds to the emotional burden on patients.

Why focus on patients with brain tumors?

* These patients have specific needs due to the rapid progression of their condition,
* A local study showed that 12% of patients with gliomas live alone, a significantly higher rate than in other cancer types. Patients who live alone are particularly exposed to issues related to their pet's future,
* Given the high morbidity and mortality associated with brain tumors, proactive planning for pet care is particularly urgent.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with a brain tumor.
* Patients who own at least one pet.

Exclusion Criteria:

* Patients who decline to participate in the study.
* Patients unable to complete the questionnaire.