cyrilzakka/clinical-trials huggingface dataset:
Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings

Adolescent girls and young women (AGYW) at risk of HIV in sub-Saharan Africa, frequently (20-50%) have symptoms of common mental disorders, including depression, anxiety, and stress. These symptoms are associated with suboptimal adherence to HIV pre-exposure prophylaxis (PrEP), a highly effective HIV prevention approach. In this project, the team seeks to address poor mental health and consequent impacts on PrEP adherence and among AGYW at risk of HIV by testing an evidence-based mental health intervention (the Youth Friendship Bench SA) adapted for PrEP delivery programs.

This is a randomized hybrid implementation-effectiveness trial which will be conducted in a real-world healthcare setting. Eligible women who accept open-label daily oral PrEP (n=110) will be enrolled and randomized to either the Youth Friendship Bench SA intervention (plus standard-of-care mental health services as needed) or standard-of-care mental health services alone. Randomization will be conducted in a 1:1 ratio with randomly-sized blocks of ≤10.

HIV-uninfected women ages 18-25 in Johannesburg, South Africa, who have symptoms of common mental disorders as evidenced by a score greater than or equal to 7 on the SRQ-20 will be eligible to enroll.

The investigators hypothesize that the Youth Friendship Bench SA will significantly improve PrEP adherence and reduce symptoms of common mental disorders among AGYW at Month 3.

Eligibility Criteria:
Inclusion Criteria:

* Female 18-25 years of age at screening
* Documentation of symptoms of a common mental disorder, as evidenced by a score greater than or equal to 7 on the Self Reporting Questionnaire 20-item (SRQ-20)
* Willingness to enroll and be randomized to either the Youth Friendship Bench SA or standard-of-care mental health services
* Written informed consent (obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study.
* Able to verbally communicate in one or more study languages to ensure participation in the counseling sessions (English, isiZulu)
* Taking PrEP at the Ward 21 clinic, as determined by clinic records. PrEP provision will be conducted by the clinic following National PrEP Guidelines and will not be part of study-specific procedures.

Exclusion Criteria:

* Not on PrEP and/or not intending to use PrEP for the duration of the study
* Planning to relocate in the next three months
* Report of suicidal intent or self harm
* Active, unmanaged mental health disorders, including untreated or severe somatic symptoms and active psychiatric symptoms (e.g., hallucinations)
* Reactive or positive HIV test at enrollment (based on clinic records only; HIV testing will not be performed under this protocol)
Partial Synovectomy in Articular Side of Quadriceps Tendon Verified to Reduce Crepitus in Retrospective Study

Crepitus causing unsatisfied result to patients after posterior stabilized total knee arthroplasty. Recent retrospective study demonstrated removal of hyperplastic synovium in distal quadriceps caused reduce of crepitus. However, this study has limitation of time gap exist between arms, different in observation time and bias caused by retrospective review. Thus aim of this study is that by randomized trial, verified hyperplastic synovium in distal quadriceps causing crepitus.

Target enrolled patients in this study are scheduled to perform both total knee arthroplasty. Experimental group is randomized side (right or left) of knee, and control group is other side of knee. Both arms decided by randomized number table. Crepitus measured after 3mo, 6mo, 1year after surgical treatment

Surgical treatment of TKA with synovium removal in distal quadriceps tendon performed classifed as experimental arm and TKA wiout synovium removal classified as control arm. Before surgical treatment, radiologic and physiological evaluation performed to check too much variance shown in either arm. Radiologic parameter include Hip knee ankle angle, Femoral tibial angle, Level of joint line, Insall-Salvati ratio, Posterior tibial slope, Posterior femoral condylar offset, Patellar thickness, Patellar tilt, Patellar displacement. During surgical treatment patella resurfacing in either group excluded this study. Indication of patella resufacing is ICRS grade IV in lateral surface of patella. After surgical procedure done check grade of crepitus (0-no crepitation, 1-fine crepitation, 2-coarse crepitation) with WOMAC, Knee Society Score, Eq-5D (European quality of life -5 Dimensions), Forgotten joint score after 3month, 6month and 1year after surgical procedure.

Other collecting variance Age, Gender, BMI, Range of motion of knee, Fmoeral/Tibial component size, PE thickness

Eligibility Criteria:
Inclusion Criteria:

1.Patients who scheduled to perform both total knee arthroplasty(TKA) using posteiror crucitate sustain type (PS)

Exclusion Criteria:

1. Lost follow up (Including death of patient)
2. Unexpected complication (e.g) Infection, periprosthetic fracture)
3. Patella resurfacing
4. Canceled surgical treatment
5. Refused to enrolled study
6. Too much radiological or physicological variance shown between either knee
French Survey About Student's Sleep Perturbations Before Simulation Session.

High fidelity simulation provide educational skills but the simulation of critical events could eventually provide anxiety among participants.

The anxiety could raise before the simulation session and affect the perceived quality of sleep the night prior to the simulation session. The lack of sleep would eventually affect both participation and memorization during the simulation session. The investigators would like to investigate with a survey how much participants had their sleep affected before the simulation session.

High fidelity simulation provide educational skills but the simulation of critical events could eventually provide anxiety among participants.

The anxiety could raise before the simulation session and affect the perceived quality of sleep the night prior to the simulation session. The lack of sleep would eventually affect both participation and memorization during the simulation session.

The investigators would like to investigate with a survey how much participants had their quantity and quality of sleep affected before the simulation session.

Eligibility Criteria:
Inclusion Criteria:

* french talking residents coming to high fidelity simulation

Exclusion Criteria:

* refusal to participate
A Study is to Understand the Treatment Patterns for Immunotherapy Agents and BRAF/MEK Inhibitors Used in the Treatment of Advanced Melanoma

The goal of the study is to understand the treatment patterns for immunotherapy agents and BRAF/MEK inhibitors used in the treatment of advanced melanoma


Eligibility Criteria:
Inclusion Criteria:

* Patients must have ≥1 medical or pharmacy claim for nivolumab, ipilimumab, pembrolizumab, nivolumab+ipilimumab (on the same day), dabrafenib, vemurafenib, cobimetinib, trametinib, dabrafenib+trametinib (on the same day) and vemurafenib+cobimetinib (on the same day)
* Patients must have ≥6 months of continuous health plan enrollment prior to index date
* Patients must have ≥2 medical claims at least 30 days apart with a diagnosis for melanoma during the study period AND ≥1 diagnosis for melanoma during the baseline period prior to or on the index date

Exclusion Criteria:

* Patients with ≥1 claim for the agents of interest including immunotherapy agents and BRAF/MEK inhibitors between the first diagnosis of metastatic disease and the day prior to the index date will be excluded
* Patients with a claim for acquired immunodeficiency virus (AIDS) anytime during the study period
* Patients under the age of 18 as of index date

Other protocol defined inclusion/exclusion criteria could apply
Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma

To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.

Patients are randomized to receive either DOX-SL or the BV combination. Infusions are given on day 1 and every 3 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients who respond to therapy will be followed every 2 months for up to 1 year. Patients must agree to have one or more representative KS lesions biopsied.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month.
* Maintenance therapy for tuberculosis, fungal, and herpes infections.
* Therapy for new episodes of tuberculosis, fungal, and herpes infection except with potentially myelotoxic chemotherapy.
* Foscarnet for cytomegalovirus infection.
* Erythropoietin.

Patients must have:

* Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:
* At least 15 mucocutaneous lesions.
* Six or more new lesions in the prior month.
* Documented visceral disease with at least five accessible cutaneous lesions.
* Documented anti-HIV antibody.
* No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if REQUIRING treatment with myelotoxic drugs).
* Life expectancy \> 4 months.

NOTE:

* Patients who fail the BV combination or who relapse are eligible to enter the Liposome Technology open trial using DOX-SL alone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Clinically significant cardiac disease.
* Confusion, disorientation, CNS symptoms, or peripheral neuropathy.

Concurrent Medication:

Excluded:

* Other cytotoxic chemotherapy.
* Colony-stimulating factors.
* Ganciclovir.

Patients with the following prior conditions are excluded:

* Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function.
* History of idiosyncratic or allergic reaction to anthracyclines, bleomycin, or vincristine.
* History of major psychiatric illness.

Prior Medication:

Excluded:

* Cytotoxic chemotherapy or interferon therapy within the past 4 weeks.
* More than one prior cycle of bleomycin/vincristine at any time.

Prior Treatment:

Excluded:

* Radiation or electron beam therapy within the past 3 weeks.
Use of Micafungin (Mycamine®) as Antifungal Prophylaxis in Haematology and Onco-haematology

The purpose of this observational study is to describe the actual conditions of prescription of micafungin in antifungal prophylaxis in French haematological and onco-haematological units. The efficacy and the safety outcomes will be described.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient with haemopathy or paediatric patients with haemopathy or solid tumor.
* Patient hospitalized in haematology, onco-haematology or onco-paediatrics unit.
* Patient initiating antifungal prophylaxis with micafungin.

Exclusion Criteria:

* Patient presenting documented fungal infection.
* Patient already included in a biomedical study impacting the care management of invasive fungal infection at the time of inclusion.
A Study to Evaluate Potential Drug Interactions Between ALXN2080 and Itraconazole, Fluconazole & Carbamazepine in Healthy Adults

The primary objectives of this study are to determine the effect of multiple doses of itraconazole on the single dose PK of ALXN2080, to determine the effect of multiple doses of fluconazole on the single dose PK of ALXN2080 (optional), and to determine the effect of multiple doses of carbamazepine on the single dose PK of ALXN2080.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females.
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, triplicate 12-lead ECG, screening clinical laboratory profiles (hematology, clinical chemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.
* Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance
* BMI within the range of 18.0 to 32.0 kg/m2 (inclusive) and a minimum body weight of 50.0 kg at screening.

Exclusion Criteria:

* History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, psychiatric or other disorders; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
* History of meningococcal infection.
* History of additional risk factors for Torsades de Pointes (eg, heart failure, hypokalemia, family history of Long QT syndrome).
* History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within 14 days prior to Period 1 Day 1.
* History of significant multiple and/or severe allergies (hay fever is allowed unless it is active), including significant hypersensitivity reactions to commonly used antibacterial agents, including beta-lactams, penicillin, amoxicillin, aminopenicillin, fluoroquinolones (specifically including ciprofloxacin), cephalosporins, and carbapenems, which in the opinion of the Investigator would make it difficult to provide empiric antibiotic therapy or treat an active infection.
* Diseases or conditions or previous procedures known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
* History of malignancy within 5 years prior to screening, with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
* Known hepatic or biliary abnormalities (including participants with Gilbert's syndrome).
Telecoaching of People With Type 2 Diabetes in Primary Care

The objective of the study is to analyze the effectiveness and the cost-effectiveness of telecoching in improving glyceamic control and other modifiable risk factors in patients with type 2 diabetes compared to usual care only.


Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 diabetes between 18 and 75 years old on the day of the selection

Exclusion Criteria:

* Debilitating coexisting medical condition (e.g. dialysis, mental illness, cancer)
* Residents of long term care facilities
* Pregnancy
* Incapable of telephone communication in Dutch
Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty

Patients undergoing total knee arthroplasty will follow two different rehabilitation protocols. In one of them, they will start walking the day of surgery and discharged on a 48 hours basis. On the other one, start walking 3 days after surgery and discharged on a 96 hours basis. Outcomes will be satisfaction, pain, range of movement, incidence of DVT and overall complications.

Randomization will be performed concealed the day before surgery. Tranexamic acid will be used in both groups. Rapid recovery group will not be using a drain, whereas the standard protocol group will have one.

Eligibility Criteria:
Inclusion Criteria:

* Knee osteoarthritis willing to undergo total knee arthroplasty
* Age 55-79
* Consent

Exclusion Criteria:

* Hipersensibility to any of the components used
* Epilepsy
* Pulmonary embolism
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part V

The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part V is comparing standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso wrap in full term infants from resuscitation to one hour after birth.

Due to delivery rooms without adequate climate controls, even full term infants have high rates of hypothermia in the developing world. This study will compare the rates of hypothermia one hour after birth in full term infants randomized to receive standard WHO thermoregulation care (control group) or standard WHO thermoregulation care without immediate drying plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken within 15 minutes of birth at at one hour after birth with removal of the plastic bag. Hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 15% and a hypothesized 10% absolute risk reduction (66% relative risk reduction), a sample size of 276 will be used to have a power of 80% and a confidence interval of 95%.

Eligibility Criteria:
Inclusion Criteria:

* Estimated gestational age 37 weeks and greater
* Birth weight greater than 2,500gms
* Delivery in the hospital

Exclusion Criteria:

* Infant admitted to the NICU
* Birth weight less than 2,500gms
* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder
FluoroAv45 Imaging Research-in Alzheimer's Disease

Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a major matter of concern. There is now an important body of literature stating that early isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing AD. Several biomarkers are now available : specific and sensitive neuropsychological assessments, morphometric evaluation of hippocampal volume and white matter changes by MRI, cerebrospinal fluid or plasma dosage of Ab fragments and tau proteins, assessment of brain glucose hypometabolism in temporo-parietal regions with PET \[F18\]FDG. However, PET imaging using labelled compounds specifically binding to APs has been suggested to improve the diagnostic reliability and to potentially help in shortening the delay until formal clinical diagnosis of AD. F18 AV45 is a new radiotracer which kinetics characteristics allows 10 to 15 minutes acquisition 50 to 60 minutes post injection.

Objectives: The primary objective of the study is to compare F18 AV45 cortical uptake in AD, MCI patients and Healthy Controls.

Secondary objectives will be to compare cortical uptake of F18 AV45 in MCI subject who will have convert toward dementia versus those who will not, at two year follow-up period, to compare level of 18F-AV45 cortical uptake with neuropsychological testing, PET FDG hypometabolism, ApoE genotype.

Method: Prospective multicentric study. 65 patients expected to enter the study.

Primary outcome measure: Standard Uptake Volume ratios.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Alzheimer's Disease (NINCDS-ADRDA) or from amnesic MCI
* 18 \< MMS \<= 28 for patients
* 28 \<= MMS for healthy volunteers
* study period \> 7 years
* native language : french
* signed informed consent
* affiliated to a social security system

Exclusion Criteria:

* alcoholism in medical history
* diabetes
* arterial hypertension (180/100 and more)
* chronical pulmonary disease with hypoxis
* cranial traumatism with loss of consciousness \> 15 minutes
* severe depressive syndrome or anxiety
* psychiatric disease in medical history (excepted simple episodes of depression)
Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma

Mantle cell lymphoma (MCL) is not curable with conventional therapy. This study sought to improve upon standard of care in newly diagnosed, untreated MCL patients who were transplant-eligible using drugs already established as active in MCL. The combination of Rituximab-Bendamustine followed by Rituximab-Cytarabine (RB/RC) was expected to maximize pre-ASCT complete response (CR) rate compared to historical rates approximating 55% with tolerable toxicity.

This was a PII single-arm design to determine whether the regimen looked promising for further study.

Primary Objective

• To evaluate the efficacy of an alternating regimen of Rituximab-Bendamustine and Rituximab-Cytarabine (RB/RC) using the CR/Cru rate.

Secondary Objectives

* To assess safety.
* To estimate the rate of complete remission (CR), unconfirmed CR (CRu), partial remission (PR), stable disease (SD) and progressive disease (PD).
* To estimate the rate of successful stem cell mobilization after RB/RC in responding patients.
* To estimate the proportion of patients who can successfully complete the regimen and proceed to autologous stem cell transplantation (ASCT).
* To estimate the rate of neutrophil and platelet engraftment after ASCT.
* To estimate the CR/CRu and PR rate for patients with blastoid variant MCL.
* To estimate the rate of minimal residual disease (MRD)-negativity at treatment completion.

Eligibility Criteria:
Inclusion Criteria:

* Mandatory pathologic review of the diagnostic specimen(s) at Brigham and Women's Hospital or Massachusetts General Hospital
* Measurable disease
* Candidate for ASCT

Exclusion Criteria:

* Prior anti-lymphoma therapy
* Pregnant or breastfeeding
* Hypersensitivity to rituximab
* Uncontrolled intercurrent illness
* Receiving other study agents
* HIV positive on combination antiretroviral therapy