cyrilzakka/clinical-trials huggingface dataset:
Evaluating an HIV Risk Screening Tool for Orphans and Vulnerable Children in Tanzania

The goal of the research was to evaluate the performance of items within the Kizazi Kipya (K2) Orphan and Vulnerable Children (OVC) HIV risk screening tool in identifying HIV-positive children, to optimize an HIV screening tool for OVC and children and adolescents in facility settings and to assess the feasibility and acceptability of home-based HIV risk screening and testing.

Under the ongoing community-based Kizazi Kipya (K2) OVC project, program staff currently administer a 13-item HIV risk screening tool to all K2 program beneficiaries, and refers those who screen positive to facility-based HIV testing. A subset of this 13-item tool is a module of four items that had previously been used as a standalone four-question screening tool in facilities in Zimbabwe.

The primary objectives of this study are as follows.

1. To evaluate the performance of a lay cadre-administered four-item subset of the K2 HIV risk screening tool that matches the Zimbabwe evidence-based tool in predicting the HIV status of vulnerable children/adolescents represented by two populations: (a) K2 OVC beneficiaries and (b) children/adolescents attending health facilities.
2. To identify additional items in the K2 HIV risk screening tool that could be added to the four-question subset to improve the tool's performance.
3. To assess fidelity to the administration of the OVC HIV screening tool items through structured observations of community case workers in the K2 program.
4. To assess the acceptability of OVC HIV risk screening and testing implemented in the community among OVC beneficiaries in the K2 program.
5. To assess the acceptability and feasibility of integrating the OVC HIV screening tool with HIV testing among OVC community case workers in the K2 program.

Eligibility Criteria:
Children and adolescents and their caregivers:

Inclusion Criteria:

* Living in a household deemed to be at elevated HIV risk based on previously identified risk criteria
* Attending a study health facility in two regions of Tanzania
* Age 2-19 years

Exclusion Criteria:

* Previously tested HIV-positive
* History of antiretroviral treatment (ART)
* Unable or unwilling to be consented
* Age 5-19 years old, tested negative in past 6 months, and having no reported exposure to HIV through sexual contact (consensual, abuse) or through blood transfusion/needle injury.

Community care workers:

Inclusion criteria:

* conducting HIV risk screening in OVC households as part of their role in the Kizazi Kipya project in the subset of study districts where structured observations and focus group discussions were conducted

Exclusion criteria:

* unwilling to consent to the study
Treatment Preference and Patient Centered Prostate Cancer Care

The purpose of this study is to develop a preference based decision aid to assess the treatment preferences of prostate cancer patients, and to analyze the interaction of treatment preferences, type of treatment received and their relationship with health related quality of life, satisfaction with care, decision regret, and psychological health of men with localized prostate cancer.

The objective is to test the comparative effectiveness of a conjoint analysis decision aid intervention compared to usual care. The investigators will identify preferred attributes of prostate cancer treatments that will help in designing a conjoint analysis decision aid to help patients weigh treatment attributes. The investigators will employ values markers to represent clusters of values for particular aspects of treatments that are valued most by individual patients. The investigators will test if the concordance between values markers and treatment received is predictive of objective outcomes and subjective outcomes. The study hypothesis is that conjoint task may help in treatment choice and prostate cancer patients whose treatment is more concordant with their values markers will have improved outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed with non-metastatic prostate cancer
2. Has not yet started radiation or surgery
3. Provide informed consent

Exclusion Criteria:

1. Distant, metastatic prostate cancer at diagnosis
2. Has already begun treatment for prostate cancer
3. Unable to communicate in English
Conservative Treatment of Proximal Humeral Fractures

Optimal treatment of proximal humeral fractures is yet to be defined. Many of them can be treated non-operatively. The question remains on how long do we have to immobilize non-operatively treated proximal humeral fractures?

There is still controversy on best treatment of proximal humeral fractures. While some authors propose surgical treatment other advocate for conservative treatment. Traditionally, fractures treated non-operatively undergo a 3-week period of immobilization followed by progressive rehabilitation program. Nevertheless, there is little evidence to support a 3-week immobilization period. The purpose of this study is to bring evidence to support either a 1-week immobilization or 3-week immobilization period in non-operatively treated proximal humeral fractures.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 60 yo and \< 85 yo
* Acute fractures less than 1 week evolution
* Conservative treatment decided by orthopedic surgeon
* Contact between humeral head and humeral shaft.
* No gleno-humeral dislocation
* No previous surgery

Exclusion Criteria:

* Cognitive impairment
SMART Trial Longitudinal Follow-Up:Off-Pump Versus On-Pump Coronary Artery Bypass Surgery

The purpose of this study is to determine completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 initial trial participants at \> 5 years post surgery who had heart bypass surgery with heart-lung bypass (on-pump) or without heart-lung bypass (off-pump). The hypothesis is that the patency of coronary artery bypass grafts of off-pump surgery are no less durable than grafts from conventional on-pump surgery.

The Surgical Management of Arterial Revascularization Therapies (SMART) trial is a randomized, controlled, double blinded trial designed to compare completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 unselected patients referred for elective, isolated coronary bypass surgery and randomized to have coronary artery bypass performed with or without cardiopulmonary bypass. These patients were enrolled between March 2000 to August 2001.

The primary objective of this study is to test the hypothesis that the patency of coronary artery bypass grafts constructed during off-pump coronary artery bypass (OPCAB)are no less durable than the patency of those constructed during conventional CABG with cardiopulmonary bypass (CABG/CPB)after \> 5 years of follow-up (non-inferiority hypothesis).

The secondary objectives are to determine whether there are differences between these randomized groups in the following outcomes measures at \> 5 years:

1. Neurocognitive Function
2. Stroke/cerebral injury
3. Health-related quality of life
4. Myocardial perfusion and ischemia
5. Major Adverse Cardiac Events (MACE)
6. Cardiac Functional Status
7. Incidence and severity of angina
8. All cause mortality and cardiovascular mortality
9. Cost of hospital re-admissions since 1 year follow-up

Eligibility Criteria:
Inclusion Criteria:

* Referred for primary or re-operative elective coronary artery bypass graft (CABG) with coronary targets suitable for off-pump bypass graft and currently enrolled in Phase 1 of SMART Trial

Exclusion Criteria:

* Emergent CABG
* Required pre-operative intra-aortic balloon pump (IABP)
* Cardiogenic shock
* Evolving acute myocardial infarction
* Coronary artery targets unsuitable for off-pump bypass surgery
* Inability or unwillingness to provide informed consent
Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-224 in Patients With Advanced Cancer

This is a Phase 1, open-label, multi-center, first time in human study of AMP-224 in adult patients with cancer that is not responding to standard therapy. This study will be conducted in two stages consisting of a Dose-Escalation stage and an Expansion Stage.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to provide informed consent
* In Dose-Escalation: Must have solid tumor malignancy or cutaneous T-cell lymphoma that has relapsed and is refractory to standard therapy, or for which no standard therapy exists
* In Expansion Phase: Must have melanoma or ovarian cancer that is histologically or cytologically confirmed
* Ovarian cancer patients must have recurrent of persistent non-mucinous disease, and must not have received more than 2 prior chemotherapeutic regimens
* Melanoma patients must have recurrent or persistent non-ocular AJCC Stage IIIC or IV disease that is surgically incurable and unresectable
* Melanoma patients with documented BRAF mutation that is known to be responsive to BRAF inhibitors must have failed or be intolerant to such inhibitors
* Must have measurable disease
* Must be able to provide access to archival (Dose-Escalation Phase) and/or fresh tumor tissue (Dose-Escalation and Expansion Phases) at Screening prior to study entry
* Must by at least 18 years old
* Must have adequate organ function

Exclusion Criteria:

* Prior cancer therapies must have completed at least 14 days or 5 half-lives (whichever is longer) prior to first dose of AMP-224
* Prior treatment with an anti-PD1 antibody therapy
* Known antibody response against prior antibody therapy or fusion protein therapeutics
* Major surgery within 4 weeks prior to first dose of AMP-224
* Prior allogeneic or autologous bone marrow or organ transplantation
* Known and/or a history or evidence of autoimmune disease except vitiligo, resolved childhood asthma and stable hypothyroidism
* Received an immunomodulatory drug within 2 weeks of first dose of AMP-224
* Active infections requiring antibiotics, physician monitoring, or recurrent fevers \>100.4 degrees fahrenheit associated with a clinical diagnosis of active infection
* Patients with cirrhosis
* Clinically significant cardiac or electrocardiogram abnormalities
* History or evidence of HIV
* Active viral disease (except when the viral infection is associated with the malignancy)
* Regular use of illicit drugs or a recent history of substance abuse
* Pregnant or breastfeeding women
Immediate Effects of Two Semi-occluded Vocal Tract Exercises

This study aims to observe the physiological effects of two different Semi-occluded vocal tract (SOVT) exercises in the larynx when they are executed by individuals with constant vocal effort and without vocal pathology.

SOVT is a voice education or rehabilitation method that involves different postures which partially occlude or elongate the vocal tract. It causes a change in the vibration pattern of the vocal folds. SOVT postures have been postulated to produce changes in contact quotient (CQ), measured with electroglottograph (EGG). This study aims to observe the physiological effects of two different SOVT exercises in larynx when they are executed by people with constant vocal effort and without vocal pathology. In order to do so, EGG will be performed before and after 43 volunteers execute two SOVT exercises (tongue trill and resonance tubes). The following parameter will be captured: CQ. A t-paired test will be performed to compare pre and post-test information. Furthermore, a generalized estimating equation will be fit to find the effects of each exercise in the subjects.

This protocol was modified due to different administrative issues related to the use of the stroboscopy (one of the assesment tools previosly considered), so that stroboscopy was removed from the protocol.

Eligibility Criteria:
Inclusion Criteria:

* No current or past history of voice disorders.
* No current or past voice training or therapy.
* Vocal use larger than 20 hours per week.

Exclusion Criteria:

* Laryngeal pathology during execution of stroboscopy.
* Flu-like symptoms during measures.
* Trouble with execution of semi-occluded vocal tract exercises.
* Allergy to electrodes.
Safety Study of Rabies Vaccine INDIRAB® Five Doses (0.5ml) Post Exposure Administered Intramuscularly

An open label, non-comparative bridging study to evaluate the safety of Rabies vaccine INDIRAB® in Healthy Vietnamese volunteer aged from 5 years old.

The trial is a bridging study to evaluate safety of Rabies vaccine INDIRAB® Five Doses (0.5 ml) post exposure administered Intramuscularly in healthy Vietnamese Volunteer Aged from 5 years old. 120 subjects will be enrolled in Cho Gao district, Tien Giang province, in which there are 100 adults (≥15 years old) and 20 children (5-\<15 years old). These subjects will be received 5 doses (0.5ml) INDIRAB® on D0, 3, 7, 14 and 28.

The frequency, rate and severity of immediate adverse events (AE) within 30 minutes after vaccination, solicited and unsolicited AE within 7 days after each vaccination, the frequency and rate of serious adverse events (SAE) within 35 days after the first vaccination will be recorded as evidences for INDIRAB® safety assessment. The subjects to be included from this trial would be representative of the population of Vietnam.

The protocol has been reviewed and approved by Institutional Review Board of Pasteur Institute in Ho Chi Minh City and Vietnam Ministry of Health - Independent Ethics Committee and Vietnam Minister of Health.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female aged from 5 years old. Women of childbearing age must use an appropriate method of contraception.
2. Subjects had sign written consent form to participate in the study. With subjects aged from 5 to below 18 years old, parents/legal representative had sign written consent form for children to participate in this study.
3. Subject who gave voluntary to comply with the study requirements.

Exclusion Criteria:

1. Subjects have atopic allergy or severe allergy to any component of vaccine.
2. Subjects with mental illness, mental retardation.
3. Subjects with severe acute or chronic disease may affect safety (eg: hepatobiliary disease, kidney disease, diabetes, hypertension...).
4. Subjects received rabies vaccine.
5. Subjects with hemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection.
6. Subjects who received other vaccine within 28 days before INDIRAB® vaccination, or those who had another vaccination schedule during the study.
7. Pregnant or lactating women.
8. Subjects had been participated, are participating, are going to participate in any other clinical trials during the period of this study.
The Effects of Three Different Modalities of Exercise in Patients With Schizophrenia

Exercise has been shown to improve health in patients with schizophrenia. However, it remains unclear which modality of exercise reports better benefits.

Aim: To compare the effects of different modalities of exercise training on psychological and physiological variables in schizophrenia.

Exercise has been shown to improve psychological, physiological, and biological correlates in patients with schizophrenia. However, it remains unclear which modality of exercise reports better health benefits.

Aim: To compare the effects of three different modalities of exercise (aerobic, strength, aerobic-strength) on psychological and physiological variables in patients with schizophrenia.

Design: Randomized clinical trial

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia
* Age between 18-65 years

Exclusion Criteria:

* Patients with other mental diseases
* Patients with mental disabilities
* Patients who present motor or behavioral pathologies that prevent the realization of the exercise training.
Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children

Studies to date on the effects of Moringa oleifera in diabetes and anemia and animal studies that examine the utility of moringa for increased milk and litter yield are of small scale, however high-quality large-scale placebo or case-controlled clinical trials to define the impact on infants of moringa leaf powder consumption by breastfeeding mothers are lacking. Moringa has a traditional and agricultural history of use as a galactagogue; despite this and its incorporation into products such as Mother's Milk Tea© and placement on NIH LactMed Lactation Database, this property has not been studied in large clinical trials nor in populations dependent on breastmilk such as in Kisumu, Kenya. This study will improve and add to existing knowledge of moringa's effect on human breastmilk and will provide novel information on the effect of moringa supplementation to lactating mothers on their infant's intestinal inflammation and health. After trial registration, the study was modified to include infant follow up to 18 months for some measures and the children's groups were removed. Although the study was modified to an 18 month follow up, the data were not able to be collected.

Further understanding of the acceptability of moringa leaf in a staple food of porridge and more the effect of moringa supplementation on infant and childhood growth, nutrition, and intestinal and systemic inflammation may translate in the future to the cultivation of moringa at the community or household level as an effective resource for the improvement of childhood undernutrition.


Eligibility Criteria:
Inclusion Criteria:

* lactating women at least 18 years of age and their exclusively breastfed infants within 14 days of delivery.
* children 6-59 months of age who eat food

Exclusion Criteria:

* regular maternal consumption of moringa
* receipt and consumption of food supplementation program
* inability to feed orally or refusal to eat moringa or placebo porridge
* for infants, prematurity (\<36 weeks gestational age)
* for infants, significant congenital disease
* for infants, inability to feed orally
Aspirin Dose Comparison in Elderly PCI Patients: 30mg vs. 75mg in Acute Coronary Syndrome

Elderly patients undergoing percutaneous coronary intervention (PCI) face a high risk of both ischemic and hemorrhagic complications necessitating antiplatelet therapy. Previous data indicate that even at a dose of 20-30 mg/day, aspirin (ASA) allows almost complete inhibition of thromboxane (TX) A2 biosynthesis in healthy volunteers. However, ASA at a dose of 30 mg/day has not been evaluated in the acute phase of myocardial infarction or among elderly patients, where it may achieve an optimal balance between bleeding risk and ischemic complications.

This randomized study will include 40 patients over 65 years undergoing PCI for acute coronary syndrome (ACS). It compares a new dual antiplatelet therapy (DAPT) strategy consisting of a P2Y12 antagonist (ticagrelor) and ASA at a very low dose of 30 mg/day (n=20) against the current standard treatment (P2Y12 antagonist and ASA at a dose of 75 mg) (n=20) in the control group.


Eligibility Criteria:
Inclusion Criteria:

* age above 65 years
* acute coronary syndrome (ACS)
* positive results for myocardial necrosis markers (troponins)
* undergoing successful coronary angioplasty with stent implantation within the last 24-48 hours before enrollment in the study
* dual antiplatelet therapy (DAPT) containing ticagrelor

Exclusion Criteria:

* indications other than ACS and PCI for DAPT use
* history of stent thrombosis during the course of DAPT
* planned subsequent coronary artery revascularization
* planned surgery requiring suspension or interruption of DAPT
* planned discontinuation of ASA or P2Y12 antagonist during the study
* use of doses other than 75 mg ASA once daily or non-use of a P2Y12 inhibitor - intake of diuretic drugs (e.g., loop diuretics, thiazides, potassium-sparing drugs)
* intake or planned intake of oral anticoagulants, parenteral antithrombotic therapy (e.g., unfractionated heparin, low molecular weight heparin, bivalirudin), glycoprotein IIb/IIIa inhibitors (e.g., abciximab, tirofiban), fibrinolytic agents (e.g., tissue plasminogen activator), or nonsteroidal anti-inflammatory drugs
* history of acute or chronic liver disease; severe kidney disease requiring dialysis; pregnancy; comorbidities associated with a predicted life expectancy of less than 1 year
* any other condition deemed by the investigator to impact hemostasis, coagulation, bleeding risk, or the ability to adhere to the study protocol; receiving a strong inhibitor of cytochrome P450 3A, simvastatin or lovastatin at doses greater than 40 mg per day, a narrow therapeutic index cytochrome P450 3A substrate (e.g., cyclosporine or quinidine), or a strong inducer of cytochrome P450 3A (e.g., rifampin, rifabutin, phenytoin, carbamazepine, phenobarbital)
* hemodynamic instability; clinical condition preventing obtaining informed consent.
US-Doppler and Procoagulant Microparticles for the Diagnosis of Asymptomatic DVT in Advanced Cancer Patients With Poor Performance Status

The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT detected by US-Doppler and procoagulant microparticles in a selected group of cancer patients suffering from an advanced stage of the disease.

An attempt will be made to determine whether there is a correlation between this prevalence and various clinical and laboratory parameters.

The association between malignancy and venous thromboembolism(VTE) is well known. VTE is one of the most common complications seen in cancer patients Early detection of VTE can identify patients who may benefit from anticoagulant therapy and prevent morbidity and mortality.

There are recommendations for hospitalized cancer patients who are bedridden with an acute medical illness to receive prophylaxis, but in practice this is not clear cut.It has been shown, in other selected groups of patients that Ultrasound Doppler can be used in order to diagnose asymptomatic DVT (deep vein thrombosis). Hematological coagulation tests, including procoagulant microparticles will be performed for the evaluation of coagulation profile, in order to evaluate the possible correlation between the prevalence of asymptomatic DVT and these laboratory parameters.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients with an advanced stage of the disease, hospitalized in the oncology department.
* WHO performance status of 3( i.e. spends more than half his/her time in bed or seated) - or 4 ( i.e. completely confined to bed or to chair) : for at least a week; according to the treating physician, the poor performance status results from advanced malignancy.
* Patient is asymptomatic for lower extremity DVT according to the treating physician

Exclusion Criteria:

* major surgery during more than a month, from the time of investigation
* anticoagulant therapy for more than one month, from the time of investigation
Cerclage for Singletons With Short Cervix Without Prior Preterm Birth

Preterm birth remains the most common cause of perinatal morbidity and mortality. A short cervi- cal length on transvaginal ultrasonography has been shown to be one of the best predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without prior PTB. However maybe the meta-analysis did not reach the statistical significance due to the small sample size


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy (limits the participants to female gender)
* Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
* 18-50 years of age

Exclusion Criteria:

* Multiple gestation
* Prior spontaneous preterm birth 16-36 6/7 weeks
* Ruptured membranes
* Lethal fetal structural anomaly
* Fetal chromosomal abnormality
* Pessary in place (or planned placement)
* Vaginal bleeding
* Suspicion of chorioamnionitis
* Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
* Painful regular uterine contractions
* Placenta previa