cyrilzakka/clinical-trials huggingface dataset:
Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL

This randomized, global, multicenter, open-label, Phase 3 study will evaluate the efficacy and safety of AV and AVG versus chemoimmunotherapy (FCR or BR) in subjects with previously untreated CLL without del(17p) or TP53. Subjects will be randomized in a 1:1:1 ratio into 3 arms through a block stratified randomization procedure.

The study includes screening (35 days), treatment (from randomization until study drug discontinuation) and follow-up phase.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years of age.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Diagnosis of CLL that meets published diagnostic criteria (Hallek et al. 2018)
* Active disease per IWCLL 2018 criteria that requires treatment.
* Participants must use highly effective birth control throughout the study.

Exclusion Criteria:

* Any prior CLL-specific therapies.
* Detected del(17p) or TP53 mutation.
* Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (e.g., Richter's transformation, prolymphocytic leukemia \[PLL\], or diffuse large B cell lymphoma \[DLBCL\]), or central nervous system (CNS) involvement by leukemia.
* History of confirmed progressive multifocal leukoencephalopathy (PML).
* Received any investigational drug within 30 days before first dose of study drug.
* Major surgical procedure within 30 days before the first dose of study drug.
* Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease. Note: Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study.
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach, or extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
* Received a live virus vaccination within 28 days of first dose of study drug.
* Known history of infection with human immunodeficiency virus (HIV).
* Serologic status reflecting active hepatitis B or C infection.
* History of known hypersensitivity or anaphylactic reactions to study drugs or excipients.
* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
* Known bleeding disorders.
* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
* Female participants must not be breastfeeding or pregnant.
* Concurrent participation in another therapeutic clinical trial.
Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.

The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.

Latest amendment clarifies that Chronic Lymophocytic Leukemia (CLL) includes T-cell Prolymphocytic Leukemia (T-PLL). Prior treatment with some drugs targeting mTOR, P13K and related pathways is now permitted.

Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed advanced solid tumor, chronic lymphocytic leukemia, small lymphocytic lymphoma, T-cell prolymphocytic leukemia, Non-Hodgkin Lymphoma or multiple myeloma
* Progressed or not tolerated standard therapy, and no further standard therapy is available
* Archival and screening tumor biopsy
* Eastern Cooperative Oncology Group Performance Status: 0 or 1
* Adequate organ function

Exclusion Criteria:

* Prior cancer-directed modalities or investigational drugs within 4 wks or 5 half lives, whichever is shorter
* Symptomatic brain metastases (prior treatment and stable metastases are allowed)
* Acute or chronic renal disease or pancreatitis
* Diarrhea ≥ Grade 2, impaired gastrointestinal absorption
* Impaired cardiac function
* History of diabetes requiring treatment, glucose \>126 mg/dL, Glycated hemoglobin (HbA1c) ≥6.5%
* Peripheral neuropathy ≥ Grade 2
* Known Human Immunodeficiency Virus (HIV) infection, chronic hepatitis B or C (unless associated with hepatocellular cancer)
* Pregnant, inadequate contraception, breast feeding
* Most concurrent second malignancies
* Part B only: Prior treatment with agents targeting both mammalian target of rapamycin (mTOR) complexes (dual mammalian target of rapamycin complex 1/2 inhibitors) and/or PI3K/AKT pathways. However, prior treatment with isolated target of rapamycin complex 1 (TORC1) inhibitors (eg., rapalogs) is allowed in both parts of this study.
Chronic Ankle Instability Diagnostic Tests Determining Underlying Deficits

Chronic ankle instability is a common condition in the active adult population and characterized by the occurrence of repeated giving way and/or recurrent ankle sprains. Multiple underlying deficits have been proposed, among which ankle muscle strength deficits, proprioception deficits, ( static and dynamic balance disorders, and articular laxity. Unfortunately, no consensus exists on which clinical tests should be realized to determine if one of these underlying deficits is predominant and as a result could guide the rehabilitation process. The study hypothesis is that people with chronic ankle instability might be heterogenous and could be divided in different subgroups as a function of underlying deficits. Therefore, this study aims to evaluate the capacity of different clinical tests to differentiate people with chronic ankle instability from healthy people as well as between each other.


Eligibility Criteria:
Inclusion Criteria:

* Case subject : at least one initial lateral ankle sprain more than 12 months before inclusion
* Case subject : at least one residual symptom among (1) giving way, (2) sensation of instability, (3) recurrent ankle sprain. This item is confirmed by a score inferior than 24 on the Chronic Ankle Instability Tool (CAIT)
* Case subject : Impact on activities of daily living and sport, confirmed by a score of less than 90% on the Foot and Ankle Ability Measure (FAAM) and less than 80% on FAAM-- - -- Control subject : matched by age and sex to case subjects

Exclusion Criteria:

* Surgery of one of the lower limbs less than 3 years ago
* Presence of heavy pain (EVA \> 8) regardless of its origin
* Acute lateral ankle sprain less than 4 months before inclusion
* Neurological disorders of any kind
* Medical treatment (drugs) interfering with muscle tone, balance and proprioception disorders
* Pregnant or breastfeeding women
* Body mass index \> 30
* Bilateral chronic ankle instability
Group Therapy for Primary Breast Cancer

The purpose of this study is to determine whether women with primary breast cancer who were randomly assigned to receive a brief group therapy would show a greater reduction in mood disturbance over time compared to those randomized to the control condition. We also hypothesized that women who were highly distressed at baseline would show the greatest benefit from participating in a support group, and that therapists with more training and experience would be most effective in reducing distress.

Breast cancer patients often experience significant psychological distress after diagnosis and during initial treatment. Group interventions for cancer patients have been shown to improve psychological adjustment. The tests of efficacy for these interventions have typically taken place in university settings using highly developed models of intervention. Our aim was to test our supportive-expressive model in community oncology practices utilizing personnel already working with these populations. To conduct this study of group therapy for primary breast cancer patients, we developed a brief version of the supportive-expressive model (Classen et al., 1993). Our first aim was to test the efficacy of this intervention for reducing mood disturbance for women who received the intervention compared to a control group. A second aim was to examine who was most likely to benefit from the intervention. A third aim was to see if this method could be taught efficiently and effectively to oncology nurses and mental health professionals.

Eligibility Criteria:
Inclusion Criteria:

* : 1) diagnosis of primary, biopsy-proven breast cancer, stages I through IIIA; 2) diagnosis occurred no more than 12 months prior to recruitment; 3) completion of initial surgical treatment; and 4) no detectable disease present.

Exclusion Criteria:

* 1) evidence of metastases beyond adjacent lymph nodes, including chest wall involvement, bone or viscera; 2) recurrence of the cancer prior to randomization; 3) diagnosis of other cancers (except for basal cell or squamous cell carcinoma of the skin or in situ cervical cancer) within the past 10 years; 4) any other major medical problems likely to limit life expectancy to less than 10 years; 5) a history of major psychiatric illness for which the patient was hospitalized or medicated, except for a diagnosis of depression or anxiety treated for a period of less than one year; and 6) attendance at a cancer support group for more than two months.
Prophylactic Antibiotic Treatment During Vaginal Repair

Prolapse of the uterus, bladder and rectum is a common condition in multiparous and/or elderly women. The number of operations for vaginal repair is increasing in Denmark, but there is no consensus or evidence found about the efficiency of prophylactic antibiotics intraoperatively concerning postoperative infections.

The objective of this randomized, controlled trial is to investigate the significance of prophylactic antibiotic treatment in vaginal repair operations.


Eligibility Criteria:
Inclusion Criteria:

* Women ages 18+ with uterine prolapse grade I - II and/or cystocele and/or rectocele and/or enterocele grade I - II and/or defects of the perineal body, in whom there is medical indication for vaginal repair, but no indication for vaginal hysterectomy or transvaginal suspension of the vaginal vault after prior hysterectomy.

Exclusion Criteria:

* Patients allergic to cefuroxime.
* Patients in whom a vaginal hysterectomy or a transvaginal suspension of the vaginal vault or other major surgery is planned, where prophylactic antibiotic treatment is standard.
* Patients suffering from physical or mental disorders that will not allow them to give informed consent.
* Pregnant and nursing women.
Ovarian Ageing in Type 1 Diabetes Mellitus

In healthy women, early menopause is an event that is associated with the exacerbation of several risk factors of cardiovascular and skeletal disease. The occurrence of an early menopause may have even greater impact in women with type 1 diabetes mellitus (DM-1). A small number of studies has demonstrated that DM-1 patients experience cycle irregularity and menopause at a younger age compared to controls. In addition, initial studies have suggested that also in regular cycling DM-1 women a decreased ovarian reserve status for age is present. The explanation for this early decay in ovarian reserve in DM-1 patients remains unknown. Next to auto immunity, vascular factors may be possible contributors to accelerated ovarian ageing in DM-1 patients.

Confirmation of more accelerated ovarian ageing in DM-1 women is urgently needed in view of the added risk factors outlined above. Also, the mechanisms behind the advanced ovarian ageing, with focus on vascular factors, may shed new light on our understanding of the ovarian ageing process per se.


Eligibility Criteria:
Inclusion Criteria:

* Patients: females diagnosed with type 1 diabetes mellitus
* Controls: healthy age-matched female controls

Exclusion Criteria:

* Induced menopause: surgical (premenopausal hysterectomy and/or bilateral ovariectomy), chemo- or radiation therapy, ovarian surgery and irregular menstrual cycles.
A Study to Evaluate the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment

The purpose of this study is:

1. To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function.
2. To assess the safety and tolerability of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

1. All subjects:

   * Written informed consent is obtained
2. Subjects with normal hepatic function:

   * The subject is in generally good health (age-appropriate) as determined by medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, coagulation, urinalysis, and serology.
3. Subjects with hepatic impairment:

   * The subject's health is otherwise clinically stable as determined by medical history, physical examination, ECG, serum chemistry, hematology, coagulation parameters (PT, activated partial thromboplastin time \[aPTT\], and international normalized ratio \[INR\]), urinalysis, and serology except for those signs and symptoms attributable to liver disease.
   * The subject has case record notes demonstrating physical signs consistent with 1 or more of the following characteristic clinical manifestations of liver cirrhosis: liver firmness to palpation, splenic enlargement, spider angiomas, palmar erythema, parotid hypertrophy, testicular atrophy, ascites (accumulation of fluid in the abdominal cavity), or gynecomastia.
   * The subject has a Child-Pugh Classification score of 7-9 points (moderate).

Exclusion Criteria:

1. All subjects:

   * The subject has any clinically significant, uncontrolled medical condition.
   * The subject is a poor metabolizer of CYP2D6 substrates based on genotyping performed at screening.
   * The subject has previously participated in a study with CEP-33237.
   * The subject has a known sensitivity or idiosyncratic reaction to hydrocodone or hydromorphone, related compounds, or to any metabolites, or any compound listed as being present in a study formulation.
2. Subjects with normal hepatic function:

   * The subject has a positive test result for HBsAg or antibodies to hepatitis C.
   * The subject has a history of alcohol, narcotic, or any other substance abuse.
3. Subjects with hepatic impairment:

   * The subject has severe ascites.
   * The subject has an acute exacerbation of liver disease as indicated by worsening clinical signs of hepatic impairment.
Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population

A two months intervention in which two groups of cognitive disorders, Parkinson and Alzheimer's disease, will receive 50g/day of a commercial MCT supplement combined with supervised aerobic exercise 3 times/week. Cognition and ketones will be assess before and after the intervention, along with endocannabinoids plasma concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's or parkinson disease diagnostic
* Stable medication associated with the disease
* Able to consent
* Presence of an accompanying person for the first and last visit.
* Ability to read and talk in French

Exclusion Criteria:

* MMSE \< 20
* MCT or coconut oil supplementation
* Coconut allergy
* Cannabis, THC or CBD consumption
* Excessive alcohol consumption
* Physical activity 3x/week
* Presence of an metallic object in the body
* Impossibility to lay in dorsal decubitus for 40 minutes
* Cardiac disease
* Any uncontrolled disease that could interfer with the project.
Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis

Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset active and progressive Psoriatic Arthritis (PsA).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adult-onset Psoriatic Arthritis (PsA) of at least 6 months' duration as defined by the Classification Criteria for Psoriatic Arthritis (CASPAR criteria)
* Active Psoriatic Skin Lesions or a documented history of Psoriasis
* Active Arthritis with ≥ 3 tender joints at Screening and Baseline, ≥ 3 swollen joints at Screening and Baseline and fulfilling at least 1 of the following 2 criteria during the Screening Period:

  1. Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hour
  2. C-reactive protein (CRP) \> Upper Limit Normal (ULN)
* Failure to 1 or more treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Exclusion Criteria:

* Diagnosis of any other inflammatory Arthritis or known diagnosis of Fibromyalgia
* Exposure to more than 1 Tumor Necrosis Factor α (TNFα) antagonist or to more than 2 previous biological response modifiers for PsA or Psoriasis
* Any non-biological systemic treatment of Psoriasis; phototherapy; topical agents
* History of chronic or recurrent infections
* High risk of infection
* Live vaccination within the 8 weeks prior to Baseline
* Concurrent malignancy or a history of malignancy
* Class III or IV congestive Heart Failure - New York Heart Association (NYHA)
* Demyelinating disease of the central nervous system
* Clinically significant laboratory abnormalities
Assessment of Functional Capacity, Pain, Cognitive and Respiratory Functions in Lung Cancer Survivors

Serious side effects occurs with disease and treatments in survival after lung cancer. For this reason, functional capacity, cognitive status, pain perception and respiratory functions may be affected in lung cancer. The purpose of this study was to evaluate respiratory function, respiratory muscle strength and endurance, functional capacity, pain, cognitive status level, and physical activity in lung cancer patients and compare with the findings of healthy subjects

This study was participated lung cancer patients survivors. Patients' pulmonary function test, functional capacity, respiratory muscle strength and endurance, pain and cognitive status was assessed and recorded.

Pulmonary function testing (PFT), mouth pressure measurement (MIP- maximal inspiratory pressure and MEP- maximal expiratory pressure), respiratory muscle endurance test, six minute walk test (6MWT) and pain threshold and tolerance test were used. In addition to physiological measurements, the Montreal Cognitive Assessment (MoCA) scale was used to evaluate cognitive status, the International Physical Activity Questionnaire (IPAQ) was used to determine the level of physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Cooperation
* lung cancer patients who had a stable condition

Exclusion Criteria:

* Active cancer treatments
* Brain metastasis story
* Any orthopedic disease impairs walking, balance
Predictors of the Ability to Protect the Airway in Long-term Ventilated Patients

First part of a 2 part study with the same IRB protocol #, and labeled 'A'. Investigators hypothesized that clinical muscle strength assessment (manual muscle testing) predicts the ability to protect the airway during swallowing in long-term ventilated subjects. More specifically, the investigators hypothesized that low muscle strength is associated with the inability to clear secretions from the peri-laryngeal area (valleculae and pyriform sinus residue scale (VPSR scale \[NRS: 0-4\] of \> 1) and entering the materials into airway (PAS scale \[1-8\]\> 1), which should predispose to endotracheal aspiration.


Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to the Respiratory Acute Care Unit and Surgical Intensive Care Unit, units with a mixed collection of long term ventilated patients in a major academic teaching hospital.
2. Age over 18 years.
3. Long-term ventilated patients (\>10 days) with tracheotomies

Exclusion Criteria:

1. Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0.
2. Non-cooperative patient, CAM score positive for delirium.
3. For women: pregnancy.
Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years

The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) regimen or a tenofovir disoproxil fumarate (TDF) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC.


Eligibility Criteria:
Key Inclusion Criteria:

* Currently receiving an antiretroviral regimen of E/C/F/TAF FDC (or emtricitabine \[FTC\]/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 \[NCT02616783\]) for ≥ 3 months
* Documented plasma HIV-1 ribonucleic acid (RNA) \< 50 copies/mL during treatment with E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 \[NCT02616783\]) for the last 2 visits preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL)
* Adequate renal function, an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance

Key Exclusion Criteria:

* An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
* Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
* Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Mental Health and Aggression in Congolese Ex-combatants

The purpose of this study is examine, whether a treatment approach, which is specifically tailored for perpetrators who have participated in violence (a variant of Narrative Exposure Therapy) is effective in the reduction of instrumental aggression and symptoms of posttraumatic stress disorder.

The reintegration of former child soldiers and ex-combatants is a big challenge in war-torn countries. Former child soldiers and ex-combatants often suffer from mental health problems and show enhanced levels of aggression. The present study focuses on the reduction of appetitive aggression and the improvement of mental health in former child soldiers and ex-combatants in DR Congo.

Eligibility Criteria:
Inclusion Criteria:

* Ex-combatants in Congo who live in a re-integration camp