cyrilzakka/clinical-trials huggingface dataset:
Protein, Nutrition and Cardiovascular Disease in Stage 5 Chronic Kidney Disease

National Kidney Foundation guidelines recommend a dietary protein intake of 1.2 grams per kilogram per day (g/kg/d) in hemodialysis patients. However, it is unclear whether consumption of high amounts of protein in dialysis patients has beneficial or harmful nutritional and cardiovascular effects in this population. High protein intake might improve nutritional status, but it has been argued that the state of low muscle mass, small body size and low serum protein levels is not the result of decreased dietary intake, rather a result of hypercatabolism induced by metabolic acidosis, inflammation and oxidative stress.

The specific aims of this study are to examine in a prospective cohort of hemodialysis patients the longitudinal associations of absolute total protein intake or dietary protein intake with muscle mass and arterial stiffness.

It is hypothesized that in the dialysis population overall: (1) Protein intake is a major determinant of muscle mass while inflammation, oxidative stress and metabolic acidosis play a lesser role; (2) Malnutrition is not an uremic cardiovascular risk factor hence low protein intake does not cause cardiovascular disease; and (3) In the other extreme, high protein intake is also not a major cause of cardiovascular disease since high serum phosphorus associated with high protein intake can usually be controlled by the use of phosphorus binders in routine clinical practice.

The specific aims of this proposal are to examine in a prospective cohort of hemodialysis patients the longitudinal associations of absolute total protein intake (TPI) in grams/day, or dietary protein intake (DPI) normalized to body weight in grams/kilogram/day) with

1. Nutritional status (mid-thigh muscle mass as measured by Magnetic Resonance Imaging ) and functional status (6-min walk) and
2. Arterial stiffness (aortic pulse wave velocity)

Understanding the relationship between protein intake with body composition (muscle mass) and intermediate cardiovascular outcomes (arterial stiffness) in stage 5 CKD patients in hemodialysis is of great scientific and practical significance

Eligibility Criteria:
Inclusion Criteria:

* Adult stage 5 chronic kidney disease patients, on dialysis for at least 3 months.
* Urine output \> 200 mL/day

Exclusion Criteria:

* Patients with persistent volume overload (substantial pedal edema) despite attempts at achieving dry weight
* Patients with inability to walk or who use a wheel-chair with reduced mid-thigh muscle mass
* Persons with pacemakers, cochlear implants, or other prohibitive conditions for magnetic resonance imaging
* Atrial fibrillation
* Patients who are unlikely or unable (in the opinion of the nephrologists, nurses or dieticians taking care of the patient) to comply with research protocol
* Patients with symptomatic heart failure, current active malignancy (excluding squamous and basal cell skin cancers), active AIDS, chronic lung disease requiring supplemental oxygen therapy and cirrhosis
* Patients enrolled in interventional trials
Turkish Nationwide SurvEy of Glycemic and Other Metabolic Parameters of Patients With Diabetes Mellitus

This study evaluates the overall cardiovascular risk status and best predictors of optimal metabolic control of Turkish adult patients with diabetes mellitus.

Diabetes mellitus is one of the most common chronic diseases with an increasing prevalence worldwide.The prevalence of diabetes is also increased significantly in Turkey, from 7.2 % in 2002 to 13.7% in 2012.This increasing prevalence leads to serious public health problems and a significant economic burden. Therefore, the optimal treatment of diabetes and prevention of diabetic complications, especially the cardiovascular outcomes, is utmost important. Although achieving glycemic targets in patients with diabetes is of great importance, blood glucose is not the only predictor of cardiovascular outcome in diabetes. Optimization of other metabolic parameters such as lipids, arterial blood pressure (ABP), and body weight as well as a healthy lifestyle are utmost important. As there is hardly enough data about glycemic and other metabolic control parameters in Turkish adult patients with type 1 or type 2 diabetes, this nationwide survey was performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 or type 2 diabetes
* Upper than 18 years old
* To be under follow-up in the same center for at least one year.

Exclusion Criteria:

* Pregnancy
* Younger than 18 years old,
* History of decompensated liver disease,
* History of psychiatric disorders interfering cognition or compliance
* History of bariatric surgery
* History of renal replacement therapy.
Developing Non-Communicable Disease Registries in Africa : A Step Towards Providing Quality Data for Improving Patient Outcomes

This umbrella protocol seeks to develop robust data registries for non-communicable diseases (NCDs) in sub-Saharan Africa (SSA) with the aim of providing accurate and comprehensive data for the evaluation of such diseases in sub-Saharan African countries.Healthy volunteers will be included in the study for comparison.

Additionally, the investigators aim to describe the gut microbiome community diversity of a cohort of community dwelling Nigerians and compare with CRC patients in Nigerian and at MSK. We will collect stool for microbiome and metabolomic analysis from community dwelling persons in the catchment area of ARGO facilities in Nigeria while contemporaneously administering an extensive medical and environmental exposure questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older.
* Suspected or confirmed diagnosis of a non-communicable disease. OR
* Healthy volunteers/no confirmed diagnosis for comparison.

Exclusion Criteria:

* Participants unwilling to sign consent.
* Participants under the age of 18
Influence of Sedentary Time on Skeletal Muscle Protein Metabolism

This study will investigate the influence of increased sedentary time on long-term measures of muscle protein synthesis and metabolic health. The investigators will test the hypothesis that increased time spent in sedentary behaviours will lead to a reduction in long-term measures of muscle protein synthesis and compromised metabolic health.

Sarcopenia, the loss of muscle mass with age, is thought to be accelerated by an inactive, sedentary lifestyle. Increased sedentary time has consistently been associated with lower muscle mass and compromised metabolic health. However, there is currently a lack of direct evidence to support these associations.

Therefore, this study will investigate whether increased sedentary time (reduced step count and exercise cessation) directly influences long-term measures of muscle protein synthesis and metabolic health in young, active adults. Following a 7 day period of normal habitual physical activity, participants will undertake a 7 day period of step reduction and exercise cessation. It is hypothesised that 7 days of increased sedentary time will result in a reduction in long-term rates of muscle protein synthesis and a worsening of metabolic health.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (18.5-29.99 kg/m2)
* Active - defined as: ≥ 7000 steps per day (assessed during screening) and taking part in regular exercise (defined as participation in ≥ 3 sessions of aerobic and/or resistance exercise type sessions a week for ≥ 6 months prior to recruitment)
* Good general health

Exclusion Criteria:

* Lidocaine allergy
* Hypertension (≥140/90 mmHg)
* Current participation in another clinical study
* Previous participation in this study
* Bleeding disorder/s
* Current or recent smoker
* Past history of substance abuse and/or taking prescription or non-prescription medication (e.g., beta-blockers, insulin or thyroxine) or supplements that may influence normal metabolic responses.
* Participants who have previously (within 5 years of the present study) had 4 or more muscle biopsies obtained from the thigh quadriceps region will be ineligible.
Safety & Immunogenicity of MMR Vaccine by DSJI to That by Needle-Syringe in 15-18 Months Old Children

This is a study planned to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 15 to 18 months.

This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical study to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 15 to 18 months. Sera samples will be analyzed by ELISA for seroconversion / seropositivity for each individual component of vaccine i.e. measles, mumps and rubella at 35 days after administration of a single dose of MMR vaccine of Serum Institute of India.

Eligibility Criteria:
Inclusion Criteria:

1. Normal healthy infants of age 15-18 months at the time of the screening and have not received their first dose of MMR vaccine.
2. Previously received a measles monovalent vaccine at 9 months, as confirmed by the childhood vaccination record.
3. Parents or legal guardians of subject willing to give written informed consent and willing to comply with study protocol.
4. Free of obvious health problems as established by medical history and screening evaluation including clinical examination.

Exclusion Criteria:

1. Infant subject participating in other clinical trial or planned participation in another clinical trial during the present trial period
2. Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy.
3. Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or to a vaccine containing the same substances.
4. Infant with history of epilepsy or a seizure disorder or neurodevelopmental disorders.
5. Clinical history of measles, mumps, or rubella infection.
6. Infants with leukemia, lymphoma, or any other cancer or neoplasm.
7. Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, neurological, cardiovascular, metabolic, hepatic or renal functional abnormality, as determined by medical history, and physical examination tests, which in the opinion of the investigator, might interfere with the study objectives
8. Infant with any other condition, which, in the opinion of the investigator would jeopardize the safety or rights of the infant participating in the study or making it unlikely the subject could complete the protocol.
Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2008

QUESTIONS AND OBJECTIVES OF ALL-MB-2008 STUDY

1. Whether the early PEG-asparaginase in induction will lead to the earlier achievement of remission, improvement of days 8 and 15 responses leading to an earlier reconstitution of bone marrow and immunocompetence, decrease of severe infections and early mortality rate?
2. Whether the use of PEG-asparaginase in induction will allow to avoid the anthracyclines in standard risk group patients and to reduce treatment myelotoxicity?
3. Whether the administration of 9 doses of PEG-asparaginase 1,000 U/m2 instead of 18 doses of E.coli L-asparaginase 5,000 U/m2 in standard risk patients will improve treatment outcome?
4. Whether the administrations of high dose methotrexate (2 g/m2 in 24 hours) during 1-st consolidation in intermediate risk patients will result in decrease of central nervous system relapse incidence and improvement of event-free and overall survival? Whether the increase of 6-mercaptopurine starting dose up to 50 mg/m2 in 1-st consolidation phase (instead of 25 mg/m2) will decrease in relapse risk, but would not be accompanied with enhanced toxicity?
5. Is it possible to completely avoid the cranial irradiation in intermediate risk patients? In some subgroup of intermediate risk patients? Is it enough to control neuroleukemia in these patients to introduce additional TIT in the consolidation phase of treatment? How will change the possible late effects in these patients according to the third arm of randomization?
6. Will the new risk group stratification to improve overall and event-free survival?


Eligibility Criteria:
Inclusion Criteria:

1. Age at diagnosis at 1 to 18 years.
2. The start of induction therapy within a time interval of study recruitment phase.
3. The diagnosis of ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow.
4. Informed consent of the parents (guardians) of the patient to be treated in one of the clinics included in this multicenter study.

Exclusion Criteria:

1. ALL is a second malignant tumor;
2. The disease is a relapse of previously misdiagnosed and, therefore, inadequately treated ALL;
3. There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
4. There is a lack of important basic data needed for the exact adherence to the cytostatic therapy according to a specific protocol of chemotherapy (differential diagnosis of acute lymphoblastic/myeloid leukemia is not possible, stratification according to risk group is not possible);
5. The patient was treated before for a long time with cytotoxic drugs;
6. There were deviations in the treatment not covered by the protocol and/or not due to side effects of treatment and/or complications of the disease
An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia

This study is designed to estimate the effectiveness of nivolumab when given to participants after removing their cancer with surgery, over a 5-year follow-up, in real-world conditions in Australia.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Adults with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete surgical removal and have no evidence of disease
* Decision to treat with adjuvant nivolumab therapy has already been taken
* Ability to provide written informed consent to participate in the study

Exclusion Criteria:

* Adults with a current diagnosis of persisting advanced melanoma
* Adults currently enrolled in an interventional clinical trial for his/her melanoma treatment

Other protocol-defined inclusion/exclusion criteria apply
Permission to Collect Blood Over Time for Research

To determine whether biomarkers assessed in blood samples can be used to detect individuals at risk for developing blood clots or worsening of their underlying disease. The ultimate goal of the study is to identify key biomarkers derived from blood that are most characteristic and informative of individuals who will go on to develop a clotting complication.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, \>= 18 years old. There are no ethnic restrictions.
* Active cancers of the GI tract (gastroesophageal, colorectal, or pancreatic-biliary) that have completed TNM staging by the American Joint Committee on Cancer; stage III disease if diagnosed within 2 months and all stage IV disease
* Ability to understand and the willingness to sign a written informed consent document.
* Existing staging CT imaging study

Exclusion Criteria:

* Life expectancy \< 6 months
* History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
* Known pregnancy or positive urine pregnancy test in pre-menopausal women
* On anticoagulant therapy (heparin, warfarin, direct thrombin inhibitors)
* No CT imaging studies, or contraindications to undergoing CT imaging
* Existing or anticipated need for a tunneled central venous catheter
* Clinic visitation to Stanford Cancer center for secondary consultation purposes only
* Inability to give informed consent
Evaluating the Clinical Cost-effectiveness of Two Primary Mental Health Service Frameworks in Yogyakarta, Indonesia

This study is a cluster randomised controlled trial, which aims to examine the short-term strategy of addressing treatment gap through increasing primary mental health service capacity. This study aims to compare after 6 months and 12 months, the effectiveness of a specialist model of mental health care and an enhanced usual care (task-sharing) framework, in terms of reducing mental health symptoms, reducing disability, and improving quality of life, as well as the health services costs (and potentially societal costs) associated with these outcomes in 400 patients.

Two primary mental health service frameworks in Yogyakarta are compared: the specialist framework and the enhanced usual care framework. Both frameworks have not been evaluated in the Indonesian context, despite their potential to be the framework of choice for other provincial and district governments to adopt. Extension to existing services has been planned, which provides us with the opportunity to implement in a random manner the enhanced usual care framework in new areas.

This study aims to compare after 6 months and 12 months, the effectiveness of a specialist model of mental health care and an enhanced usual care (task-sharing) framework, in terms of reducing mental health symptoms, reducing disability, and improving quality of life, as well as the health services costs (and potentially societal costs) associated with these outcomes in 400 patients. This study receives ground-level support from the Centre for Public Mental Health, Universitas Gadjah Mada, which manages the specialist primary mental health framework in Yogyakarta province, regional and national-level support from the Ministry of Health of Indonesia, and will be hopefully funded by the LPDP, Ministry of Finance of Indonesia.

Eligibility Criteria:
Inclusion Criteria:

* Participants are adults who meet the screening criteria for depression and anxiety on the self-report General Health Questionnaire (GHQ-12)

Exclusion Criteria:

* Potential participants who are currently receiving treatment for any mental health disorders will not be invited to participate in the study.
Pharmacokinetic (PK) Study of Twice Daily vs Once Daily Lamivudine (3TC) and Abacavir (ABC) as Part of Combination Antiretroviral Therapy (ART) in HIV Infected Children

Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.


Eligibility Criteria:
Inclusion Criteria:

* Children with definitive HIV infection
* Age \> 2 and \< 13 years
* Currently on combination ART including 3TC and / or ABC, for at least 6 months, with stable CD4 cell count and HIV RNA viral load and expected to stay on this regimen for at least a further 3 months.

Exclusion Criteria:

* • Intercurrent illness

  * Receiving concomitant therapy except prophylaxis against Pneumocystis carinii pneumonia (PCP)
  * Abnormal renal or liver function (grade 3 or above)
A Cross-sectional Study of Ocular Manifestations During the Covid-19 Pandemic in Hubei Province

To investigate the clinical features of ocular manifestations during the novel coronavirus pneumonia pandemic in Hubei at the end of 2022

During late 2022 COVID-19 pandemic ocular discomforts were common in people with mild systemic symptoms, but most resolve on their own without any treatment. The disease spectrum of ophthalmology outpatient clinics is affected by the COVID-19 pandemic. In our study, we observed that the incidence of keratitis and acute angle-closure glaucoma in Phase A was significantly higher than that in Phase B and C.

Eligibility Criteria:
Inclusion Criteria:

* 1. 2022.12.7 to 2023.2.6 People surveyed by wechat Questionnaire Star 2. 2021.12.7 to 2022.1.6 and 2022.11.7 to 2023.1.6 Patients who received ophthalmology treatment in Zhongnan Hospital of Wuhan University and Qichun People's Hospital

Exclusion Criteria:

* 1. currently hospitalized patients. 2. severe patients. 3. Incomplete information. 4. cannot be contacted by telephone. 5. Refuse questionnaire survey. 6.The electronic medical record information is incomplete. 7. Those who do not go to the ophthalmic clinic after registration. 8.severe patients. 9. Cannot be contacted by phone.
Pharmacokinetic Study of Multi-dose Chloroquine

Chloroquine (CQ) remains an alternative cheap, safe and widely available drug. Our previous research has shown that double (50 mg/kg) standard dose CQ given in split doses had a 95% efficacy and was well tolerated and safe. Still, safety could be an issue when the dose of CQ is increased. Severe adverse events are caused by high peak concentrations of CQ. Using split doses of CQ avoids high peak concentrations enabling the safe administration of high doses, however, pharmacokinetic data are lacking.

Children included in the study will be given 50 mg/kg as split doses over 3 days or 70 mg/kg as split doses over 5 days. Treatment will be observed. Drug concentrations and adverse events will be monitored. On day 1, children and their mother/guardian will be requested to stay at the health centre between 9 am and 6 pm.

Fifteen children aged 2-10 years with uncomplicated P. falciparum malaria and fulfilling the inclusion criteria will be recruited into each study arm.

Following the end of treatment, the children will be seen on the morning of day 7, 14, 21 and 28.

Any child wishing to withdraw during the treatment phase and any child with reparasitaemia during the follow up will be given rescue treatment with arthemeter-lumefantrine or quinine according to treatment guidelines in Guinea-Bissau.

Final analysis will include a description of included children, proportions of adverse events and any serious adverse events, drug concentrations and their relation to adverse events, the proportion of children withdrawn or lost to follow up, the cumulative PCR corrected and uncorrected success and failure rates on day 28 and the proportion of early, late clinical and late parasitological treatment failures.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 2 years and \< 10 years.
* Mono-infection with P. falciparum detected by microscopy. Parasitemia of 1.000-100.000/µl asexual forms.
* Axillary temperature ≥ 37.5 ˚C or a history of fever within 24 hours.
* Ability to swallow oral medication.
* Ability and willingness to comply with the study protocol.
* Informed consent from a parent or guardian

Exclusion Criteria:

* Signs or symptoms of severe malaria.
* Presence of general danger signs in children under 5.
* Persistent vomiting.
* Presence of severe malnutrition.
* Any evidence of chronic disease or acute infection other than malaria.
* Regular medication which may interfere with antimalarial pharmacokinetics.
* History of hypersensitivity reactions or contraindications to chloroquine.