cyrilzakka/clinical-trials huggingface dataset:
Improved Access to Quality Care and Healthcare Use

This study is an individual-level randomised controlled trial which looks at the effect of providing free access to higher quality providers in urban South Africa. The study will recruit about 1,500 individuals with a child aged 5 or under. They will be randomly allocate to a control group (CONTROL) with the default free access to government facilities or one of the two treatment groups where they will have free access to private providers located either relatively close (CONVENIENT) by or relatively far (INCONVENIENT). The primary outcomes be overuse and underuse of healthcare services for children under 5

In many low-income settings, provision of social services by the public sector is plagued by problems of quality and low accountability to users. As a result, low expected benefits or fear of neglect by service providers may delay the use of needed services, even when those are free.

In South Africa, the health system is characterised by stark inequalities, with most of the population only able to seek care in free government facilities. The low quality of the public sector, where patients wait long times to be seen by nurses, is believed to lead many to delay needed care and prevent health outcome improvement. The government of South Africa is developing proposals to introduce a national health insurance scheme that would provide free access to private providers who deliver higher care quality. However, concerns about the unequal geographical distribution of private providers raise questions about the potential benefits of the reform. This study asks several questions to inform this reform:

1. Does access to higher-quality care reduce under-use of services for children but also increase overuse?
2. Does access to higher-quality care lead to improved health knowledge of parents and better health outcomes for children?
3. Are these effects mitigated by the distance to the contracted providers? A randomised controlled trial is used to answer these questions. The study will recruit about 1,500 individuals who are the primary caregiver of at least one child aged six or under. and randomly allocate them to a control group (CONTROL) with the default free access to government facilities or one of the two treatment groups where they will have free access to private providers located either relatively close (CONVENIENT) by or relatively far (INCONVENIENT).

The primary outcomes will be the proportion of visits that are considered unnecessary (overuse) and the number of days of illness where care-seeking is recommended by guidelines but not sought by the child's parent or guardian.

Secondary outcomes will include (1) the number of days with ill-health symptoms; (2) out-of-pocket expenditures; (3) health knowledge of parents; (4) subjective and (5) objective measures of child's health.

Eligibility Criteria:
Inclusion Criteria:

* parent has a child aged under 6 years old and over 2 months old

Exclusion Criteria:

* is planning to move out of the area in the next 3 months
* has private medical aid
Prognosis in the Elderly Chinese: the Northern Shanghai Study

The Northern Shanghai Study is a prospective community-based study, which is aimed to investigate the prognostic factors, including conventional cardiovascular risk factors and asymptomatic target organ damage, for mortality and cardiovascular diseases, in 5,000 elderly Chinese.


Eligibility Criteria:
Inclusion Criteria:

1. age≥65 years old(depending on identity card);
2. informed consent should be signed voluntarily;
3. the individuals are long-term residents in northern Shanghai.

Exclusion Criteria:

1. is diagnosed serious heart disease (NYHA\>IV) or end stage renal disease (CKD \> 4);
2. suffered with cancer and life expectancy was less than 5 years;
3. has stroke within 3 months;
4. is not willing to participate in the clinical study;
5. suffered with other disease to quite the trial;
6. violated the protocol;
7. lost contact with laboratory staff.
Effectiveness of Smart Phone Application in Improving Oral Health Behaviours of Adolescents

This study would be a first step towards mobile-health associated Sustainable Development Goals by World Health Organization, as there are no mobile-health driven oral health activities in Karachi, Pakistan. Concurrently, it will help in improving knowledge and practices of adolescents towards general dental hygiene as this age is crucial for the prognosis of newly erupted permanent teeth. This would help in preventing chronic problems of adulthood. This will also help in reducing the number of days missed from school, increasing self-confidence of individuals as bad breath has a negative impact on one's self-esteem and confidence, giving a positive sense of aesthetics and will also keep in check over-all body health.Persistent unmaintained dental hygiene also overburdens families due to its high-maintenance outcomes like caries and early tooth loss. Dental treatment is considered as fourth most expensive treatment in developing countries . According to recent studies, households of low and middle income countries are at a higher risk of falling below the poverty line due to expenditure on dental problems. Such a simple intervention making use of modern-day technology would enable adolescents to keep their oral health in check and would prevent them from facing consequences of poor oral health.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent of age between 14-19 years
* Having access to an android device at home; either personal or parents'
* Would be able to use the app twice every day- Having access to Wi-Fi at home- for downloading the app.
* Willing to give consent
* participate in the study till the follow-up period.

Exclusion Criteria:

* - Having mixed dentition
* Undergoing orthodontic treatment
* Should have no serious existing gingival or dental problems\* that could hinder calculation of plaque or gingival scores
* Should have no serious existing gingival or dental problems\* that could hinder routine brushing.
* Taking medications that have effect on gingival/dental health
* Having intrinsic or extrinsic enamel defects/ tooth malformations
* Having more than 1/3rd of the tooth stained due to areca nut chewing, smokeless tobacco (gutkha) chewing or cigarette smoking.
Bioavailability of Vitamin D(25(OH)D) and Omega-3 Fatty Acid (DHA) Enhanced Chicken

The purpose of the research is to evaluate if chicken that is fed a diet that contains omega-3 fatty acids (DHA/EPA), vitamin D (as 25(OH)D) or both nutrients provides additional health benefits by improving the status of omega-3 fatty acids and 25(OH)D in healthy adults who eat this bioenhanced chicken.

The 2015-2020 Dietary Guidelines advocate intake of lean proteins (such as chicken and fish) while limiting intake of saturated fat. Chicken contains similar protein to beef or pork but has less saturated fat. However, chicken, like other terrestrial meats, has little omega-3 polyunsaturated fatty acids such as docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA) and relatively little vitamin D. Vitamin D insufficiency is common in the US and globally, and has been linked to a number of adverse health outcomes. Vitamin D is ingested primarily from fortified dairy products, but recent animal studies have increased the D content of pork and beef, and the DHA content of chicken. Moreover, sunlight exposure alone can enhance the 25(OH)D content of chicken. Notably, supplemental 25(OH)D is more effective than vitamin D at improving vitamin D status in humans, but little is known about the bioavailability of 25(OH)D or DHA/EPA enhanced chicken (muscle).

Eligibility Criteria:
Inclusion Criteria:

* healthy adults
* Non-smoking
* Age between 18- 24 yo
* Females: premenopausal and not pregnant or lactating
* Body mass index (BMI) between 18 - 30 kg/m2.
* No preexisting medical complications (such as eating disorders, gastrointestinal disorders, malabsorption diseases, or taking medications known to influence iron homeostasis)

Exclusion Criteria:

* BMI \<18 or \> 30 kg/m2,
* Age \<18 y or \> 50y,
* Smoking
* Pregnancy, lactating
* Have gastrointestinal disorders/malabsorption diseases/dietary restrictions/medication use of medications known to impact DHA/EPA or Vitamin D 25(OH)D absorption
* Take vitamin and mineral supplementations
Neural Injury in Adolescents With Concussion

This study utilizes multimodal brain imaging to obtain quantitative biomarkers of brain injury and to improve understanding of the biological basis of brain pathology in adolescents with concussion. Adolescents with a concussion will undergo neuroimaging and neuropsychology assessments acutely and four months after injury.

Concussion is a highly prevalent condition in adolescence, but it remains a clinical diagnosis that largely relies on subjective patient report with no reliable objective biomarkers for diagnosis. Traditional clinical brain imaging has not been found useful for concussion as the pathology is generally not visible on conventional acute MRI or CT. The proposed study addresses this gap in concussion diagnosis and management by examining the sensitivity of magnetoencephalography (MEG) for identifying areas of brain injury through detection of abnormal neural activity (slowing) in adolescents with concussion compared to healthy controls. Adolescents with a concussion will complete neuroimaging (MEG and MRI) and neuropsychology assessments at two time points within ten days and then again 4 months post-injury. Healthy controls will complete neuroimaging and neuropsychology assessments at a single time point.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of concussion and within 2 weeks of injury (case subjects)
* No history of diagnosed concussion (control subjects)

Exclusion Criteria:

* Head injury within 1 year of recent concussion (case subjects)
* History of neurologic, psychiatric, developmental or learning disorders (all subjects)
Dual Mobility Cup: Does it Improve Patient's Satisfaction After Total Hip Arthroplastry?

Although the success of total hip arthroplasty, many patients were dissatisfied postoperatively. Patient's reported outcome measures become of a great importance in assessment of the results after joint replacement. The aim of this prospective study is to evaluate and compare postoperative patient's satisfaction after implantation of two commonly used different designs of total hip arthroplasty.

The investigators conducted a prospective comparative study carried out on 180 patients suffering of hip arthritis between 2011 and 2018. They were randomized into two groups of homogenous demographic and clinical data. Group A was treated by cementless T.H.A. with a large head while group B received cementless T.H.A. with a dual mobility cup. Clinical evaluation and preoperative patient's expectation were assessed and compared to the postoperative satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral hip arthritis
* Age up to 65 years
* Body mass index (BMI) up to 35
* Modified Charnley comorbidity classification equal to A

Exclusion Criteria:

* Neurological deficit (e.g. Parkinsonism, stroke)
* Bone type c not fit for cementless fixation
* Poly-arthritis, active inflammatory arthritis (e.g. rheumatoid arthritis)
* Any patient with psychiatric disorders
Newborn Screening for Adrenoleukodystrophy

To test if the routine newborn screening dried blood spots can be used to test if elevation of C26:0 lysophosphatidylcholine (C26:0-lyso-PC), a status indicating adrenoleukodystrophy (ALD)

Parents of newborns will be invited to test if their newborns are affected with ALD. The routine newborn screening dried blood spots sample will be used to test the concentration of C26:0-lyso-PC . If positive of a screening test, further confirmation tests including physical examination and other methodology for ALD confirmation will be provided. Genetic counseling and treatment option will be provided, too.

Eligibility Criteria:
Inclusion Criteria:

* Babies born in Taiwan receive regular newborn screening suggested by Ministry of Heath and Welfare.
* Parents or Legal Guardian sign in the informed consent form.

Exclusion Criteria:

* Parents or Legal Guardian do not agree to sign in the informed consent form.
Rituxan and BEAM With Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma

To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant.

Objectives: I. To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant. II. To determine if the addition of Rituxan changes the toxicity profile attributed to high-dose BEAM chemotherapy.

This protocol is a phase I/II trial combining the Rituxan as a pre and post-transplant agent to aid in the chemotherapy sensitization and the treatment of minimal residual disease post-transplant.

Eligibility Criteria:
Inclusion Criteria:

* Any low-grade B-cell, CD20 positive, non-Hodgkin's lymphoma that is felt to otherwise be a transplant candidate (relapsed, induction failure, first PR or CR).

  o Small lymphocytic, marginal zone, mantle cell, and follicular histologies.
* At least 19 years of age
* Signed written informed consent
* Expected survival of at least 6 months
* WHO performance status greater or equal to 2
* Male or female subjects of reproductive potential who are able to follow accepted birth control measures.

Exclusion Criteria:

* No history of T-cell lymphoma
* Not pregnant or lactating women
* No serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study
Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia

Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy parameter is percent change in LDL-C after 8 weeks of therapy.

Following a 35-day washout of current lipid-lowering medication (if any) and adherence to a low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, OR AEGR-733 2.5 mg + atorvastatin 20 mg for 4 weeks followed by AEGR-733 5 mg + atorvastatin 20 mg for 4 additional weeks. During the entire study, subjects will be instructed to follow a low-fat/low cholesterol diet and limit alcohol consumption to -/\< 1 drink per day.

Eligibility Criteria:
Inclusion Criteria:

* M/F 18-70
* 0-1 risk factor, mean LDL-C -/\> 160 and -/\< 250 mg/dL (Visit 2 \& 3)
* 2+ risk factors, mean LDL-C -/\> 130 \& -/\< 250 mg/dL (Visit 2 \& 3)
* Fasting mean TGs -/\< 400 mg/dL
* Understanding and compliance of protocol
* sign consent

Exclusion Criteria:

* Females pregnant, lactating, or CBP who have not been using acceptable contraceptive methods over previous 3 months
* Uncontrolled hypertension \>180/95 at screening
* Hx of chronic renal insufficiency (serum creatinine \> 2.5 mg/dL)
* Hx of liver disease or transaminases \> 1.5 X ULN
* Positive for Hepatitis B or C
* Major surgery within past 3 mos
* Cardiac insufficiency defined as functional Class II-Class IV
* Hx of malignancy within previous 5 years
* Participation in another investigational drug study within past 6 wks
* Serious or unstable medical or psychological condition
* Regular alcohol use \> 1 drink per day
* Regular consumers of grapefruit juice or medications known to be metabolized by CYP 3A4
* Use of other lipid-lowering meds (washout permitted)
* Acute CVD
* Diabetes Mellitus
* Fasting glucose \>110 mg/dL
* BMI -/\> 40 kg/m2
* Significant gastrointestinal symptoms such as IBS
* Use of fish oils, niacin, herbal wt. loss products (washout permitted)
Generic Immunosuppressive Drugs After Lung Transplantation

Extent of use of generics immunosuppressive drugs in clinical practice after lung transplantation

Solid organ transplant recipients are treated with immunosuppressive drugs to prevent rejection of their grafts. The most frequently important maintenance immunosuppressive drugs in Europe are calcineurin inhibitors.

For a number of these compounds drug patents have expired in recent years and generic formulations have entered the market. There is considerable debate regarding the efficacy and safety of generic drug substitution in solid organ recipients.

Eligibility Criteria:
Inclusion Criteria:

* patients after lung transplantation (single, double or combined)
* informed consent
* patient with an immunosuppressive therapy with tacrolimus or ciclosporin

Exclusion Criteria:

* immunosuppressive therapy without calcineurin inhibitors
* need for isolation (Colonization with multi. or pan resistant organisms e.g. methicillin-resistant staph. aureus\[MRSA), B. cenocepacia)
* limited German language skills or other reasons which might impair patient communication or computer handling
A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time

The purpose of this study was (i) to develop a brief counseling letter intervention aiming to reduce sedentary time and to increase physical activity during leisure time among adults aged 42 to 64 years and (ii) to provide information on the feasibility.

The study aimed to assess the feasibility of a brief counseling letter intervention to increase physical activity and to reduce sedentary time in leisure time.

Following the Intervention Mapping Protocol we developed the counseling letter intervention. The intervention is based on the Health Action Process Approach, comprising 3 tailored letters based on separate assessments, delivered over 6 month.

All participants consented (i) to participate in an examination at the university hospital including standardized measurements of blood pressure, waist and hip circumference, body height and weight as well as blood sample taking, (ii) to fill in a paper-pencil questionnaire, and (iii) to wear an accelerometer for 7 days at baseline and at 12-month follow-up.

A general population sample of cardiovascular healthy adults was randomly allocated to a control and an intervention group. At 5 time points (baseline, 3-month, 6-month, 7-month, and 12-month follow-up) participants of both study groups completed standardized questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* age between 42 and 65 years
* resident in a pre-defined zip-code area

Exclusion Criteria:

* cardiovascular event (myocardial infarction, stroke) or vascular intervention
* self-reported body-mass-index over 35 kg/m²
Role Of Serum Adiponectin In The Ealy Detection Of Renal Impairment In Patients With Non Alcoholic Fatty Liver Disease

Early detection of renal impairment in patients with Non-alcoholic fatty liver disease and its correlation with serum Adiponectin level.

Nonalcoholic fatty liver disease (NAFLD) includes different types of liver damage, ranging from simple steatosis and nonalcoholic steatohepatitis (NASH) to liver cirrhosis and even hepatocellular carcinoma.(1) NAFLD is diagnosed by the presence of more than 5% fat accumulation in liver cells after excluding excessive alcohol intake in patients as well as other secondary causes of liver disease, such as drug-induced liver injury, viral and autoimmune hepatitis.(2) The diagnostic criteria for chronic kidney disease (CKD) are either the reduced estimated glomerular filtration rate (eGFR) (\<60 mL/min/1.732) and/or abnormal albuminuria and/or overt proteinuria in patients for at least 3 months.(3) The association between NAFLD and CKD has recently attracted the attention of many experts. NAFLD and CKD share some common pathophysiological mechanisms as well as some metabolic risk factors for cardiovascular disease. Some studies have confirmed that the presence of NAFLD increases the risk of CKD and that the degree of liver fibrosis is related to CKD stage,(4) It is crucial to detect early renal impairment in patients with NAFLD to prevent CKD progression, minimize complications, and improve survival (1) Adiponectin is a recently identified adipose tissue-derived protein (adipocytokine) with important metabolic ,antiinflammatory, anti-atherogenic, and reactive oxygen species protective actions.(4) Adiponectin is one of the key regulators involved in glucose and lipid metabolism. Further analyses have shown its anti-inflammatory and anti-apoptotic roles in human cells.

Data from large cross sectional studies showed a positive correlation between serum Adiponectin and mortality in chronic kidney disease.(5)

Eligibility Criteria:
Inclusion Criteria:

1. Patients with fatty liver aged from 18 to 60 yrs either diabetic or not .
2. Patient with normal echogenic kidney in ultrasound and eGFR more than 60 mL/min/1.73m2.
3. The Control group are completely healthy subjects without any systemic or liver and kidney affection

Exclusion Criteria:

* 1)Patients less than 18 yrs \& more than 60 yrs 2)All patients having any other causes of renal and hepatic disease rather than Diabetes and having any other systemic problem.
Multicentric Registry for the Detection of C5 Palsy After Anterior Cervical Discectomy and Fusion

Detect the reason for the frequently occurring C5 palsy after anterior cervical discectomy and fusion

A registry which includes all known and individually analyzed but even new factors are evaluated in order to perform a multivariate analysis for the detection of risk factors of C5 palsy after anterior cervical discectomy and fusion which is a very disabling and still cryptic complication.

Eligibility Criteria:
Inclusion Criteria:

* ACDF or cervical vertebral body replacement due to herniated disc, spinal stenosis or trauma

Exclusion Criteria:

* infectious disease or neurodegenerative disease
Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids

From patients with intermediate risk non-muscle invasive bladder cancer tumor (NMIBC) specimens will be harvested during transurethral resection. Fresh specimens will be cultured as patient derived organoids (PDO). After approx. 10 days, PDO are exposed to different drugs that are used as intravesical instillation agents in these patients (epirubicin, mitomycin, gemcitabine, docetaxel). After 2 days of exposure, PDO viability will be measured. The drug with the highest antitumor effect on PDO will be applied as weekly intravesical instillations 6 times. Thereafter, patients are followed according to the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Signed Informed Consent Form
* ECOG performance status of 0 or 1
* Histologically confirmed intermediate risk non muscle-invasive urothelial carcinoma of the bladder (pTa low grade) Patients
* Representative fresh tumor specimen for PDO generation and drug screen

Exclusion Criteria:

* Known previous high grade and/or high risk non muscle-invasive bladder cancer
* Previous Intravesical biological/immuno (BCG) therapy
* Pregnancy or nursing
* Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
* Severe infection within 4 weeks prior to cycle 1, day 1
* Contraindication for frequent catheterization
* Voiding dysfunction
* Pregnancy or nursing
* Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 6 months after the last treatment.
* Male subject who is unwilling to use acceptable method of effective contraception during IP treatment and through 6 months after the last dose of IP.