cyrilzakka/clinical-trials huggingface dataset:
Youth Partners in Care: Depression and Quality Improvement

This randomized effectiveness trial evaluates a quality improvement intervention aimed at providing access to evidence-based depression treatments (particularly cognitive-behavior therapy for depression and or pharmacotherapy) through primary care for youth ages 13-21, as compared to enhanced usual care. The major hypothesis is that the quality improvement intervention will be associated with improved outcomes, relative to enhanced usual care.


Eligibility Criteria:
Inclusion Criteria:

* Met either of two criteria: 1) endorsed "stem items" for major depression or dysthymia from the 12-month Composite International Diagnostic Interview(CIDI-12,2.1) modified slightly to conform to diagnostic criteria for adolescents, 1-week or more of past-month depressive symptoms, and a total Center for Epidemiological Studies- Depression Scale(CES-D)40 score ≥ 16, or 2) CES-D score ≥ 24.
* Age 13-21
* Presented at primary care clinic

Exclusion Criteria:

* not English-speaking
* provider not in study
* sibling already in study
* completed eligibility screener previously
NOTES Transvaginal Cholecystectomy and Appendectomy

Natural Orifice Translumenal Endoscopic Surgery (NOTES) is considered by many leading expert surgeons to be the next step in MIS (Minimally Invasive Surgery). This is a rapidly evolving area of preclinical research and several groups worldwide are developing this surgical approach together with industry support. In this new surgical technique, abdominal operations are performed using the oropharynx, rectum, or vagina as the ports of entry to the peritoneal cavity instead of incisions on the abdominal wall. NOTES offers all the advantages of minimally invasive surgery (MIS) and also completely eliminates trauma to the abdominal wall and the numerous complications of abdominal wall incisions. A NOTES procedure eliminates any visible scar and could also potentially reduce post operative pain due to the elimination of abdominal wall trauma.

In this trial we intend to operate healthy women who need to undergo cholecystectomy or appendectomy. The operations will be performed through the vagina as the access port to the peritoneum and it will be monitored with laparoscopic vision for safety reasons.


Eligibility Criteria:
Inclusion Criteria for group #1 Transvaginal cholecystectomy:

1. Females between the ages of 18 and 50
2. Diagnosis of gallstone disease which requires cholecystectomy
3. ASA class 1

Exclusion Criteria for group #1 Transvaginal cholecystectomy:

1. Pregnant women
2. Morbidly obese patients (BMI \> 35)
3. Patients who are taking immunosuppressive medications and/or immunocompromised
4. Patients with severe medical comorbidities will be excluded.
5. Patients with a presumed gallbladder polyps, mass or tumor
6. Patients with a history of prior open abdominal or transvaginal surgery.
7. Patients with a prior history of peritoneal or vaginal trauma
8. Patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis
9. Patients with known common bile duct stones
10. Patients on blood thinners or aspirin or abnormal blood coagulation tests

Inclusion Criteria for group #2 Transvaginal appendectomy:

1. Clinical diagnosis of appendicitis
2. Emergency room evaluation within 36 hours of the onset of pain
3. ASA Classification

Exclusion Criteria for group #2 Transvaginal appendectomy:

1. pregnant women
2. Morbidly obese patients (BMI \>35)
3. Patients who are taking immunosuppressive medications or are immunocompromised
4. Patients with evidence of an abdominal abscess or mass
5. Patients who present with a clinical diagnosis of sepsis or peritonitis
6. Patients who have a history of prior open abdominal surgery or prior transvaginal surgery.
7. Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
8. Patients with diffuse peritonitis on clinical exam
9. Previous trauma to the perineal area
10. Patients on blood thinners or aspirin or abnormal blood coagulation tests
Ph 1 Trial of ADI PEG 20 Plus Sorafenib to Treat Patients With Liver Cancer

Assessment of safety and tolerability of ADI-PEG 20 in combination with sorafenib in advanced Hepatocellular Carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

1. Prior diagnosis of HCC confirmed histologically.
2. HCC tissue either from an archived specimen or from a new biopsy of sufficient amount and quality should be available for IHC determination of ASS status, and other biomarkers, to be performed retrospectively. Subjects with no tissue available would require a biopsy.
3. No prior treatment with systemic chemotherapy (except as noted in exclusion criteria # 10).
4. Measurable disease using RECIST 1.1 criteria (Appendix A). At least 1 measurable lesion must be present. Subjects who have received local-regional therapy such as (but not limited to) chemoembolization, embolization, cryoablation, hepatic artery therapy, percutaneous ethanol injection, radiation therapy, radiofrequency ablation or surgery are eligible, provided that they have either a target lesion which has not been treated with local therapy and/or the target lesion(s) within the field of the local regional therapy has shown an increase of ≥ 20% in size. Local-regional therapy must be completed at least 4 weeks prior to the baseline CT scan. Local therapies including chemoembolization do not count as prior systemic therapy.
5. Cirrhotic status of Child-Pugh grade A. Child-Pugh status should be determined based on clinical findings and laboratory data during the screening period (Appendix B). Subjects on anti-coagulants are to receive 1 point for their INR status, as they are presumed to have a \<1.7 baseline PT/INR.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Appendix C).
7. Expected survival of at least 3 months.
8. Age ≥ 18 years.

Exclusion Criteria:

1. Candidate for potential curative therapies (i.e., resection or transplantation).
2. Prior allograft transplantation including liver transplantation.
3. Serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.
4. Pregnancy or lactation.
5. Expected non-compliance.
6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV; Appendix D), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.
7. Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional therapies.
8. Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis.
Thermal Stimulation for Stroke Patients

Sensory and/or motor deficits in upper limb following stroke often have negative impacts on their daily living. Thermal stimulation with hot and cold pack alternatively incorporated into conventional rehabilitation has been reported and proved to be effective for upper limb functional recovery after stroke. However, whether hot- and cold-water stimulation alternatively based on thermal stimulation also has the effect still remains unknown. The aim of present study is to investigate the facilitated effect of hot and cold water stimulation alternatively on upper limb after stroke.

Stroke patients from department of rehabilitation in Tzu Chi general hospital will be recruited and randomized into two groups, one for experimental group and the other for control group. In addition to receiving routine standard rehabilitation for both groups, the experimental group will receive additional hot- and cold-water stimulation alternatively for five times one session, consecutive four sessions a set, one set for 30 minutes a day and five sets a week for six weeks. The control group will be given ergometer exercises with the similar duration as experimental group. Both groups will be evaluated at baseline before TS and every two weeks till six weeks after TS, then at 3, 6 and 12 months for follow-up. A variety of evaluations used in the present study include Semmes-Weinstein monofilaments for sensory functions; Brunnstrom's stage, Fugl-Meyer Assessment Scale and Motricity Index were used for upper limb motor control and strength; Box and block test for hand dexterity. The modified Motor Assessment Scale and Barthel Index are utilized for evaluating general motor functions and daily activity performance, respectively. The modified Ashworth scale is used for change of muscle tone of upper limb.

Eligibility Criteria:
Inclusion Criteria:

* a first-time ischemic or hemorrhagic stroke.
* no severe diabetes or peripheral vascular disease causing sensory deficits.
* no cognition problem and follow directions indicated by therapist during experiment.
* motor deficit of the upper limb under (including) Brunnstrom stage IV, either in the arm or hand.

Exclusion Criteria:

* a cardiac disease or orthopedic problem history,
* medically unstable such as experienced unstable angina, uncontrolled hypertension according to the treating physician, psychological history before stroke.
Open Label Phase 1 Study in Japan for Patient With Advanced Solid Malignancies

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of AZD5363 under adaptable dosing schedules in Japanese patients with advanced solid malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Aged at least 20 years
* Histological or cytological confirmation of a solid malignant tumour, excluding lymphoma, that is refractory to standard therapies or for which no standard therapies exist
* At least one lesion (measurable and/or non-measurable) that can be accurately assessed according to RECIST
* World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
* Patients should be willing to remain in hospital until the completion of the first cycle including cycle 0, cycle 1, and cycle 2 Day1 (as cycle 1 Day 21)

Exclusion Criteria:

* Clinically significant abnormalities of glucose metabolism as defined by any of the following:
* Diagnosis of diabetes mellitus type I or II (irrespective of management)
* Baseline fasting glucose value of ≥7 mmol/l (126mg/dL)
* Glycosylated haemoglobin (HbA1C) \>6.5%
* Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment
* Inadequate bone marrow reserve or organ function
* Any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection
* With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants

The purpose of this study is to evaluate the PK of GDC-0853 following changes to formulation and in the presence or absence of food, the proton pump inhibitor (rabeprazole), or both. This will be a 3-part open-label randomized study conducted in healthy adult participants. Approximately 63 subjects will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female (of non-childbearing potential) participants
* Within body mass index range 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive
* In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs and physical examinations
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria:

* History or symptoms of any significant disease
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection
* Participants who previously participated in any other investigational study drug trial within 90 days prior to Check-in. Participants who previously received GDC-0853 in previous studies.
* History of malignancy
* Pregnancy, lactation, or breastfeeding in female participants
Placenta and Cord Blood Analyses

The purpose of this study is to standardize methods in collecting and processing placenta, umbilical cord and cord blood samples. Samples will be used to determine potential differences between normal weight, overweight and obese individuals.


Eligibility Criteria:
Inclusion Criteria:

* at least 7 months pregnant
* 18 years of age or older

Exclusion Criteria:

* underweight (BMI\<18.5)
To Measure Pain Perception With Electronic Pressure Algometer of Different Size Probes : a Healthy Subjects Research

This study was conducted to explore the influencing factors, subjects and testers' evaluation about pain measurement with hand-held pressure algometer with different size probes. Methods:100 healthy undergraduate students(50 males and 50 females) were recruited into this study. Pain measurement including pressure pain threshold (PPT) and pressure pain tolerance(PTO) was carried out by the hand-held pressure algometer with different size probes (from 1cm2 to 0.01cm2) on three different measuring spots in right forearm. We recorded subjects' skinfold thickness, time per test procedure, types of pain perception, receptivity and degree of accuracy as well as testers' level of laborious.

Subjects with the following diseases were excluded: known history of chronic disease, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, Pregnancy or at lactation period .

Eligibility Criteria:
Inclusion Criteria:

Aged 20 to 30 The right hand is handedness Agreed to participate the research Not with known chronic disease Not taking analgesics within 3 months

Exclusion Criteria:

* History of chronic pain Psychiatric diseases Diabetes mellitus Severe cardiovascular diseases Kidney or liver diseases Alcohol or drug abuse Heavy smoker Disagree to participate to the research
Effect of Transfusion of Plasma on Endothelial During Liver Transplantation

To study the effects of plasma transfusionon during liver transplantation on endothelial condition and short-term outcome in patients with end-stage liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Child A/B cirrhosis
* patients who undergo the first OLT
* Informed and consented
* complete follow-up
* cooperate with treatment

Exclusion Criteria:

* re-transplant
* combined liver and other organ transplantation
* BMI≥30Kg/m2
* patients with hypertension, diabetes, coronary heart disease, chronic renal insufficiency, preoperative pulmonary infection, pleural effusion
* acute liver failure
An Efficacy and Safety Study of Ravulizumab in ALS Participants

The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.


Eligibility Criteria:
Key Inclusion Criteria:

1. A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria (possible, laboratory-supported probable, probable, or definite ALS).
2. ALS onset ≤ 36 months from Screening.
3. Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
4. Upright slow vital capacity ≥ 65% predicted at Screening.
5. If on riluzole, participant must be on a stable dose for 30 days; if on edaravone, participant must be on a stable dose for 60 days (2 cycles).
6. Body weight ≥ 40 kilograms at Screening.
7. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Key Exclusion Criteria:

1. History of Neisseria meningitidis infection.
2. Human immunodeficiency virus (HIV) infection (evidenced by HIV 1 or HIV 2 antibody titer).
3. Dependence on invasive or non-invasive mechanical ventilation.
4. Previously or currently treated with a complement inhibitor.
5. Exposure to an investigational drug or device within 30 days of Screening or 5 half lives of the study drug, whichever is greater.
A Study of ARRY-502 in Patients With Persistent Asthma

This is a Phase 2 study, involving a 6-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-502 in treating mild to moderate persistent asthma, and to further evaluate the safety of the drug. Approximately 180 patients from the US will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Documented history of bronchial asthma diagnosed at least 6 months prior to study start and prior to the age of 40 years.
* Body mass index (BMI) of 18 to 35 inclusive.
* An ACQ score of ≥ 1.5 at specified time points prior to first dose of study drug.
* A best prebronchodilator FEV1 of 60% to 85% of the predicted normal value and a change in best postbronchodilator FEV1 of ≥ 12% and ≥ 200 mL at specified time points prior to first dose of study drug.
* Additional criteria exist.

Key Exclusion Criteria:

* Evidence of aspirin-sensitive asthma.
* Pre-existing lung disease other than asthma.
* Clinically significant dermatologic, hematological, renal, endocrine, pulmonary (other than asthma), gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, musculoskeletal or immunologic disease (excepting allergic disease and asthma) that is uncontrolled despite treatment or is likely in the opinion of the Investigator to require a change in therapy during the study.
* Patients with any current or past history of cancer within 5 years prior to study start except for treated basal cell or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or cervical carcinomas in situ.
* Any history of serious illness requiring hospitalization within 6 months prior to study start.
* Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
* A positive test for drugs or alcohol, unless the positive drug screen is associated with a prescribed medication and is approved by the Medical Monitor.
* Smoking (tobacco or marijuana) within 6 months prior to study start and/or a smoking history of \> 10 packs/year.
* Blood donation of ≥ 1 pint (473 mL) within 8 weeks prior to the first dose of study drug.
* Previous treatment with ARRY-502.
* Additional criteria exist.
Adaptation and Evaluation of the PMTCT CSC in Dedza and Ntcheu Districts, Malawi

This CDC-funded study sought to evaluate the effect of an adapted Community Score Card Approach on maternal retention in ART, maternal retention across the PMTCT service cascade, and the uptake of early infant diagnosis services in Malawi. The study also estimated the cost of the implementation of the Community Score Card Approach.

Prevention of Mother to Child HIV Transmission (PMTCT) services aim to identify HIV-infected pregnant and breastfeeding mothers and initiate them on antiretroviral treatment (ART) for improving the health of the mother as well as reducing HIV transmission to their infants. In 2011, Malawi was the first country to adopt lifelong ART for HIV- pregnant and breastfeeding women, known as 'Option B+'. Despite leading the way on operationalization of this approach, Malawi has faced challenges retaining HIV-infected pregnant and breastfeeding women on lifelong ART as well as with improving uptake of early infant HIV testing for HIV-exposed infants. Innovative approaches are needed which engage health service users (i.e. patients) as part of quality improvement solutions within clinical settings to improve retention throughout the PMTCT cascade and ultimately improve PMTCT outcomes for mothers and infants.

One approach to broadly engage health service users in quality improvement activities is the Community Score Card (CSC). The CSC engages both service providers and users within a clinical setting in dialogues to identify solutions to the perceived barriers with health service delivery and utilization.

CARE developed the CSC intervention in Malawi in 2002 as part of a project aimed at developing innovative and sustainable models to improve general maternal and child health services. The main goal of the CSC intervention is to positively influence the quality, efficiency, and accountability with which health services are provided at different levels. The original CSC consists of five core phases, repeated on a regular basis (called "rounds"), for the life of the project.

This project adapted the CSC to the PMTCT setting across 11 sites in two priority PEPFAR scale-up districts in Malawi. The adaptation of the CSC was evaluated through a pre-post design to measure change in maternal retention on ART, change in maternal retention across the PMTCT service cascade, and uptake of Early Infant Diagnosis (EID) services following CSC implementation. Additionally, the project estimated the cost of the adapted CSC implementation.

Eligibility Criteria:
Inclusion Criteria:

* New born infants of HIV-positive women
* Women 18 years and over newly initiating antiretroviral therapy (ART) at ART clinic
* HIV-positive pregnant women \>15 years of age newly receiving care at first ANC (ANC1)
* Women who are HIV-positive at ANC1 (known positive, already on treatment)
* Women who are newly identified HIV-positive and initiated on treatment at ANC (newly identified at ANC or labor and delivery)
* Women known HIV-positive but not yet on treatment prior to enrollment at ANC and initiated on treatment at ANC

Exclusion Criteria:

-
Health Literacy and Overweight in Adolescents

Obesity in children and adolescents has become a major public health problem in recent years. In Belgium, 20% of people aged between 2 and 17 are overweight and 7% suffer from obesity. While studies often associate this overweight with socio-economic level, other factors, such as health literacy (HL), may also play a role. Among adolescents, some studies have shown an association between the level of HL and the Body Mass Index (BMI). Our study aims to investigate the association between HL of adolescents and their BMI.

This is a cross-sectional survey among 9 high schools in a medium city of Belgium, including 254 high school students aged between 12-17 years. Health literacy was assessed by the Health Literacy Measure for Adolescents (HELMA). Student's age, sex, weight, size and parental socio-economic status are gathered in the medical file during the medical examination organized by the schools after obtaining the informed consent of the students and their parents.


Eligibility Criteria:
Inclusion Criteria:

* Studying in one of the participating school
* Being in 2nd or 4th year
* Parental consent to participate

Exclusion Criteria:

* None