cyrilzakka/clinical-trials huggingface dataset:
LEAPS-NCHD Program Evaluation

An estimated 88 million children drop out of primary school each year worldwide, and the highest number of dropouts are in the first and second grade. A proven strategy to reduce dropout from primary school is participation in early childhood care and education (ECCE) services that bolster young children's health, development and readiness for school. Access to quality ECCE services remains highly limited in Pakistan: less than 50% of four-year-olds are estimated to attend ECCE services, and skilled ECCE workers remain scarce.

To address these challenges, LEAPS (Youth Leaders for Early Childhood Assuring Children are Prepared for School) was developed as a cross-generational strategy to support the learning and development of young children (3.5- to 5.5-year-olds) and female youth (18- to 24-year-olds). The program provides vocational training to female youth, referred to as Community Youth Leaders (CYLs), to deliver a community-based preschool program in rural Sindh, Pakistan. The LEAPS program was previously developed in partnership with Pakistan's National Commission for Human Development (NCHD), a government entity charged with supporting community health, education, and vocational training programs. Efficacy and feasibility of the LEAPS strategy were demonstrated through a prior pilot evaluated in a cluster-randomized controlled trial in 2015 (NCT02645162).

The NCHD is now seeking to integrate the LEAPS program within their full suite of services and to scale the program across 99 villages in rural Sindh under the technical guidance and support of a local implementation support team led by the Aga Khan University. This intervention utilizes two strategies: i) the first is the implementation of the LEAPS program, led by NCHD; and ii) the second is the technical support of the NCHD, to ensure the system is able to support program expansion and sustainability.

This study uses a cluster-randomized stepped-wedge design with three steps to assess program impact on school readiness and child and youth development outcomes across the 99 villages ("clusters"). All clusters will begin in the control state (i.e. access to standard community services). Prior to the start of the trial, clusters will be randomized to 'cross-over' to the intervention state (i.e. introduction of the LEAPS-NCHD program) during one of three sequential steps. Each step will be approximately 9-11 months. By the end of the trial, all clusters will have been exposed to the intervention. Measurement is assessed across all clusters at each step. The total duration of the trial will be 31 months. A process evaluation will also be conducted to examine the large-scale implementation of the LEAPS-NCHD Program.


Eligibility Criteria:
Inclusion Criteria:

* Resides in the targeted villages
* Aged 54 - 66 months
* Child's primary caregiver must provide both i) informed consent for the caregiver's own participation in the study and ii) permission for the child's participation in the study.
* Child must provide assent for participation in the study.

Exclusion Criteria:

* Child shows signs of severe clinical health condition or disability.
Correlation Between Refraction and Biometric Parameters

To document the refractive status of Chinese schoolchildren and evaluate the association between the degree of refraction and biometric parameters.

In this study, we will analyze the refractive status of schoolchildren and compare the ocular biometrics, including spherical equivalent refraction (SER), pupil distance (PD), corneal curvature (CC), high order aberration (HOA), and central corneal thickness (CCT) between boys and girls. Additionally, we investigate the correlation between the SER in diopters and the other biometric parameters, including PD, CC, HOA, CCT, and body mass index (BMI).

Eligibility Criteria:
Inclusion Criteria:

* Schoolchildren aged from 6 to 15 years

Exclusion Criteria:

* with previous histories of cataracts, keratitis, strabismus, or other visual impairments
* with history of previous eye surgery
* with unreliable auto-refraction values
* unwilling to participate
Child Results Following Preventive Children of Parents With Psychiatric and Addictive Problems (COPP) Groups

This is a study evaluating changes in quality of life and global functioning across and after a manualized peer-group preventive intervention for children of parents with psychiatric or addictive problems.

Self-reported quality of life and based on the group-interviews "ILK" and "Kindl" and general adaptive functioning (CGAS) as reported by teachers and parents will be measured before, after and at follow-up relative to the manualized peer-group preventive intervention. Parents will also complete self-reports on anxiety and depressive symptoms, personality, bonding and attribution before the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Family including Parent with psychiatric or addictive problems

Exclusion Criteria:

* acute severe disorder
Prevention of Falls in the Elderly Population

An educational intervention will be utilized to improve care following guidelines for treating individuals at risk of falling. A survey will be administered to providers pre and post education.


Eligibility Criteria:
Inclusion Criteria:

* Primary care providers in Family Medicine and Internal Medicine

Exclusion Criteria:

* Providers in outlying clinics
A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the effect on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Current total daily insulin treatment lower than 1.2 (I)U/kg/day
* Body mass index 18.0-28.0 kg/m\^2

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
* Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
Azilect® In Wearing-Off (AIWO)

End-of-dose fluctuations e. g. wearing-off are defined as a recurrence of motor and non-motor Parkinson's Disease (PD) symptoms that precedes a scheduled dose and improves with the next dose of anti-parkinsonian medication. Azilect® is approved and recommended for therapy of wearing-off-/End-of-dose fluctuations and improves motor fluctuations significantly in combination therapy with L-dopa and other parkinsonian medication.

The aim of the non-interventional study is to document efficacy and tolerability of rasagiline as a combination therapy in patients with wearing-off-/End-of-dose fluctuations and the effect of rasagiline on individual wearing-off symptoms, recognized by wearing-off questionnaire 32 (WOQ-32).

Eligibility Criteria:
Inclusion:

* idiopathic Parkinson's disease based on the UK Brain Bank criteria,
* Wearing-off / end-of-dose akinesia
* at least 18 years old,
* written consent to participate in the study.

Exclusion:

* contraindications according to the SmPC of Azilect®,
* treatment with Azilect® in the past 3 months and / or
* suffering from a relevant cognitive impairment and therefore neither understand the patient information, nor can give their consent to participate.
Low-intensity Physical-cognitive Exercise and Cognitive Function

This study aims to examine the effects of low-intensity, combined physical-cognitive exercise on cognitive function of older people with mild cognitive impairment (MCI) and identify the mechanisms by which this exercise protocol exerts cognitive function. Older adults with MCI will be recruited to either an exercise or a control group. Low-intensity, combined physical-cognitive exercise will be prescribed to the exercise group 3 times per week for 3 months while the control group will maintain their routine lifestyle. It is hypothesized that at the end of the trial, participants in the exercise group will demonstrate significant improvement in cognitive performance and circulating biomarkers compared to baseline and the control group.

Accumulating evidence suggests that dementia may be preventable, especially at an early stage. Mild cognitive impairment (MCI), a preclinical phase of dementia, is a potentially reversible condition as several individuals with MCI could revert to normal level of cognition. Exercise has shown promising evidence of neurocognitive protection, however, not all studies reported such benefits. Type and intensity of exercise are two main factors that have often been accounted for discrepancies in previous findings. Based on previous evidence, low-intensity and combined physical-cognitive exercise might give the best result for cognitive enhancement.

Thus, this study aims to examine the effects of low-intensity, combined physical-cognitive training on cognitive function of older people with MCI and identify the mechanisms by which this exercise protocol exerts cognitive function in individuals with MCI. A single-blinded, randomized controlled trial will be conducted. Older adults with MCI will be recruited to either an exercise or a control group. Low-intensity, combined physical-cognitive exercise will be prescribed to the exercise group 3 times per week for 3 months while the control group will maintain their routine lifestyle. Outcome measures will be assessed at baseline and after a 3-month exercise. The primary outcome measures will be cognitive performance (specific and global cognitive function) and plasma brain-derived neurotrophic factor (BDNF). The secondary outcomes will include physical performance (functional mobility and strength), interleukin 6 (IL-6), fibroblast growth factor 21 (FGF21), and metabolomic profiles. Intention-to-treat method will be applied for data analyses.

Eligibility Criteria:
Inclusion Criteria:

* meeting the criteria for MCI (or mNCD) based on the recent DSM-V criteria
* comprehend instructions and able to comply with the study procedures
* not taking any medications for their cognition and not planning to start medications during the study trial

Exclusion Criteria:

* presence of medical condition(s) unsafe to exercise or affect cognition and mobility
* presence of depressive symptoms
* exercise regularly
A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)

The purpose of this study is to evaluate the efficacy and safety of ozanimod compared with placebo in participants with ulcerative colitis (UC) in mainland China and Taiwan. The main study is composed of an induction period, maintenance period, safety follow-up, and participants meeting certain criteria will be given the opportunity to participate in an optional open label extension.


Eligibility Criteria:
Inclusion Criteria:

Main Study:

* Eligible participants must be Chinese.
* Participant has had moderately to severely active UC diagnosed at least 3 months prior to first investigational product administration.

Open-label Extension Period:

* Participants who have completed the Week 10 Visit and are non-responders at Week 10.
* Participants who have completed the Induction Period and entered the Maintenance Period experienced disease relapse during the Maintenance Period, or who have completed the Maintenance Period at Week 52.

Exclusion Criteria:

Main Study and Open-label Extension Period:

* Participant has severe extensive colitis, diagnosis of CD, indeterminate colitis, presence or history of a fistula consistent with CD, microscopic colitis, radiation colitis, or ischemic colitis.

Open-label Extension Period:

* Participant has clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the participant at risk by continuing the study or that would have required a participant to discontinue treatment were observed during the Induction Period or Maintenance Period.
* Participant has clinically relevant cardiovascular conditions, including history or presence of recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe untreated sleep apnea were observed during the Induction Period or Maintenance Period.
Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Randomized phase II trial to study the effectiveness of amifostine followed by high-dose chemotherapy in treating patients with hematologic cancer or solid tumors.

OBJECTIVES: I. Evaluate the efficacy of amifostine in enhancing hematopoietic recovery following cyclophosphamide, etoposide, and cisplatin therapy in patients with hematologic malignancies and adult solid tumors.

OUTLINE: This is an open label study. Patients receive intravenous amifostine over 15 minutes daily 30 minutes prior to high dose chemotherapy on days 0-2. Cyclophosphamide is administered over 3 hours on days 0 and 1, intravenous etoposide over 4 hours on days 0, 1, and 2, and cisplatin over 4 hours on days 0, 1, and 2. All patients receive sargramostim (GM-CSF) beginning on day 4. Patients receive a maximum of 2 courses of treatment (with 35-42 days between chemotherapy courses). Patients are followed for 1-5 months after treatment.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed hematologic malignancies and adult solid tumors, including: Non-Hodgkin's lymphoma Lung cancer Hodgkin's disease Ovarian cancer Breast cancer No refractory disease (less than partial response to induction chemotherapy) No CNS metastases No unilateral bone marrow biopsy within 6 months of study showing at least 20% involvement by fibrosis tumors Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 70 Menopausal status: Not specified Performance Status: ECOG 0-2 Life expectancy: At least 16 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No underlying medical or psychiatric conditions No concurrent active infection No prior malignancies except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior myeloid growth factor Chemotherapy: At least 4 weeks since prior chemotherapy No more than 1 prior chemotherapy regimen (excluding adjuvant chemotherapy) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since pelvic, para-aortic, inverted Y, cranial, spinal, or mediastinal radiation Surgery: At least 2 weeks since major surgery Other: No antihypertensive medication within 24 hours of amifostine administration
Yttrium-90 Radioembolization With Glass Microspheres (TheraSphere) for Patients With Hepatocellular Carcinoma

This is a prospective pilot study that will document the clinical experience of 30 patients with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere®).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hepatocellular carcinoma with liver-dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
* The cancer is unresectable.
* All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Age 18 years or older.
* Able to understand informed consent.

Exclusion Criteria:

* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:

  * single TheraSphere administration; or
  * cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments.
* Evidence of any detectable Tc-99m macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
* Previous radiation therapy to the lungs and/or to the upper abdomen
* Pregnancy
* Symptomatic lung disease.
* Significant extrahepatic disease representing an imminent life-threatening outcome.
* Active uncontrolled infection
* Any pre-treatment laboratory findings within 30 days of treatment demonstrating:

  * Aspartate or alanine aminotransferase level greater than 5 times upper normal limit.
  * Serum bilirubin greater than 2 mg/dl
  * Infiltrative tumor on imaging
  * Tumor volume greater than 70% of liver volume
  * Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL
Predictive Factors of Good Pulmonary Penetration of Antibiotics : AntiBiotics Dosage in Broncho-Alveolar Lavage

Respiratory infections are common and sometimes very severe. An insufficient dosage of the antibiotic could lead to a treatment failure A correct plasmatic antibiotic concentration is not a guarantee of a clinical success as it could not be a reflect of pulmonary concentration. The aim of this study is to determinate the predictive factors of pulmonary penetration of antibiotics in patients with a beta lactamines failure and who undergoes a flexible bronchoscopy.

To check if pulmonary concentrations of antibiotic are enough we will measure antibiotic concentration in the broncho-alveolar lavage (BAL). This technique which is clinically relevant and reliable could determinate the pulmonary diffusion level for antibiotics by calculating the ratio between plasmatic and intra-alveolar antibiotic concentration. This ratio will be correlated with potential limitation factors of pulmonary diffusion as respiratory diseases (COPD, cystic fibrosis, fibrosis...), sepsis, hypoalbuminemia. We have chosen to study the beta lactamin antibiotics because they are the most frequently used in pneumonia. Moreover, the beta lactamins pulmonary diffusion is likely to be the lowest. Finally, for patients with a known pathogen, we will divide this pulmonary concentration with minimal inhibitory concentration (MIC). Indeed, in severe pneumonia, to be sure of bactericidal activity, a pulmonary concentration of beta lactamines should be always higher than 4 to 5 times MIC.

Eligibility Criteria:
Inclusion Criteria:

* patients who undergo a flexible bronchoscopic lavage and with a beta lactamines treatment as cephalosporin of 3rd generation (CEFTRIAXONE / CEFOTAXIME, CEFTAZIDIME), of 4th generation (CEFEPIM), or AMOXICILLIN-CLAVULANIC ACID, or PIPERACILLIN-TAZOBACTAM
* patient major
* informed and signed consent form

Exclusion Criteria:

* patient under chronic dialysis
* patient placed under judicial protection
Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing

This is a multi-center, prospective, randomized, double blind, pilot clinical trial of subjects with chronic wounds. The purpose of this study is to compare the efficacy of COPA AMD PHMB Impregnated foam dressing compared to regular foam dressing in subjects with chronic wounds.


Eligibility Criteria:
Inclusion Criteria:

* subject is 18 to 85 years of age inclusive
* subject has a foot ulcer
* subject has a leg ulcer
* subject has an open wound of at 1.0 cm (2)
* subject has one of the following: Palpable pulse, ABI \> 0.56 or toe pressure \> 50 mmHg
* subject or legally authorized rep is able to understand and willing to give written informed consent

Exclusion Criteria:

* subject has an allergy to Chlorhexidine Gluconate (CHG)
* subject has open wounds that in the opinion of the Principal Investigator do not have the ability to heal
* subject has current malignant disease or history of malignant disease in past 5 years
* subject has inability to comply with the study protocol and procedures
* subjects who require use of topical agents other than the impregnated or regular foam dressings dressings
Placental Transfusion in Term Infants: A Pilot Study

The proposed study is a pilot prospective controlled trial to measure the blood volume left in the placenta after varying cord clamping times when the infant is placed skin-to-skin on the maternal abdomen. Delaying cord clamping has been shown to decrease anemia in infants. However, the best way to get the most blood to the baby is not known. The practice of cord clamping at birth is not the same among doctors and midwives and we do not know the effect of putting he baby on the mother's abdomen.

The proposed study is a pilot prospective controlled trial to measure the placental residual blood volume after varying cord clamping protocols when the infants are placed skin-to-skin on the maternal abdomen. The study assessed compliance of the providers with the different protocols. Placental transfusion (PT) has been shown to increase infant body iron stores at 6 months of age without increasing adverse outcomes. However, the optimal protocol to achieve adequate placental transfusion is not known. The practice of cord clamping at birth is not uniform among obstetrical providers because adequate evidence to support early or late cord clamping has been lacking.

Women were eligible to enroll in the study if they had no pregnancy complications, did not smoke, planned to breastfeed, and planned to deliver vaginally between 37 and 416/7 weeks. Women were enrolled prenatally on the labor and delivery unit. At birth, women were assigned to one of four cord clamping/milking groups. A cohort of infants with immediate cord clamping serves as reference group. Infants had blood samples drawn with the routine newborn screening blood samples done at 36 to 48 hours. Information on infant health and feeding was completed through an in-hospital visit to the mother and by home visit at two weeks of age. The primary outcome measures were placental residual blood volume and compliance with the various assigned cord clamping protocols. It was expected that infants with delayed cord clamping or cord milking would have less placental residual blood volume and that most providers would comply with the various random assignments.

Eligibility Criteria:
Inclusion Criteria: Women with normal pregnancy and presented at the labor room at 38-416/7 weeks for vaginal delivery; Intention to breast feed the babies; Consent for a follow up at 2 weeks of age

Exclusion Criteria: Abnormal pregnancy: Gestational or pre-existing diabetes, smoking and substance abuse, pre-eclampsia, fetal abnormality
Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive

This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment in the advanced disease setting.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
* Tumors over-expressing Her-2
* Candidate for treatment with docetaxel/trastuzumab

Exclusion Criteria:

* Histology of inflammatory carcinoma
* AST and/or ALT \>1.5 x ULN concomitant with ALP \>2.5 x ULN