cyrilzakka/clinical-trials huggingface dataset:
Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia

This study evaluate supplementation of vitamin E (alpha-tocopherol) in obese adolescent. Half of the patient will receive vitamin E and the other half received placebo

One of obesity treatments that play important role is antioxidant diet. The effects of vitamin E supplementation as an antioxidant treatment in obese adolescent have not been concluded yet in Indonesia. The primary aim of this study is to observe oxidative stress biomarker (isoprostane) in obese teenagers who consume vitamin E for 2 months. The secondary aim is to observe their body mass index and lipid profile after supplementation

The study is randomized, double blind, placebo controlled trial in design and employed a consecutive sampling technique to sample subjects of 70 obese adolescent age 14 - 18 in senior high schools Jakarta.

Blood tests of lipid profile (total cholesterol, HDL, LDL, Triglyceride), fasting blood glucose, liver function (AST,ALT) and oxidative stress biomarker (isoprostane) were taken for every subject after done fasting for 12 hours.

This study is a randomized allocation and double blind technique. subjects divided into two groups, which one group receiving treatment of vitamin E and other group receiving placebo.

The dose and duration of vitamin E treatment is 400 IU per day for 2 months. At the end of treatment, all subjects had to run the same medical interview, physical examination and blood test.

Eligibility Criteria:
Inclusion Criteria:

* Obesity BMI ≥ p95 (CDC growth curve)

Exclusion Criteria:

* Consuming antioxidants drug regularly within recruiting time
* Consuming Orlistat
Preference of Tegaserod vs. PEG 3350 in Patients With Constipation

To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste


Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 to 64 years of age
* Patients with constipation as defined by the Rome II criteria

Exclusion Criteria:

* Patients who have been previously been treated with tegaserod and/or PEG 3350
* Evidence of cathartic colon or a history of laxative abuse or laxative dependence
* History of fecal impaction which necessitated surgical intervention
* Patients with clinically significant abnormal TSH levels at screening
* Women who are pregnant or breast feeding

Other protocol-defined inclusion/exclusion criteria may apply
Psychoeducation for Vietnamese Families With a Patient With Schizophrenia

Families with a patient with schizophrenia and the patient are randomly assigned to receive either a 3 session psychoeducation program, or no psychoeducation. Other treatment for schizophrenia and other mental illness are provided as usual.

Families with a patient with schizophrenia and the patient are randomly assigned to receive either a 3 session psychoeducation program, or no psychoeducation. Other treatment for schizophrenia and other mental illness are provided as usual. The psychoeducation program focuses on: (a) explaining schizophrenia as a medical, biological illness, (b) the prognosis for schizophrenia (e.g., that it is possible to lead a normal life), and (c) what the family and patient can do to maximize the outcome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia, based on ICD-10
* Receive in-patient treatment at hospital
* Length of schizophrenia less than 3 years.
* Treated 3 or less times for schizophrenia.

Exclusion Criteria:

* Mental retardation, or other diagnoses that could affect the ability to answer questionnaires, after the acute schizophrenia psychosis is controlled.
* Suicidal ideation
Clinical Utility of Postoperative Hemoglobin Testing

The purpose of this study is to evaluate how many patients have hemoglobin less than 10 g/dL at post-operative day 1

Obtaining a complete blood count (CBC) on post-operative day 1 to assess postoperative hemoglobin levels is routine practice at Cincinnati Urogynecology Associates, TriHealth Inc. after pelvic reconstructive surgery.

There is minimal data supporting this practice. Multiple studies throughout the gynecology literature suggest that this is not a necessary or cost effective strategy to assess for postoperative anemia. Most patients who require blood transfusion or reoperation for bleeding will show clinical signs of anemia.

The investigators aim to determine if checking a routine CBC results in clinically relevant changes to patient care in women undergoing pelvic reconstructive surgery with vaginal hysterectomy for treatment of pelvic organ prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Total vaginal hysterectomy with or without bilateral salpingectomy/oophorectomy (CPT 58260, 58262, 58263, 58270, 58290, 58291, 58292, 58294)
* At least one of the following vaginal native tissue prolapse repairs

  * Apical repair with uterosacral ligament suspension (CPT 57283)
  * Apical repair with sacrospinous ligament fixation (CPT 57282)
  * Anterior repair (CPT 57240, 57260, 57284, 57285, 57250)
  * Posterior repair (CPT 45560, 56800, 56810, 57200, 57210, 57250)
* Surgery by one of four fellowship trained urogynecologists at TriHealth

Exclusion Criteria:

* Concomitant surgical procedure by a second surgeon
* Malignancy identified at the time of surgery or active malignancy
* Cases converted to open hysterectomy or prolapse repairs
* Prolapse repair completed robotically
* Prolapse repair completed with mesh
* Known coagulopathy
* Patient on long term preoperative anticoagulant medication (Arixtra, Coumadin, Eliquis, Heparin, Lovenox, Pradaxa, Savaysa, Xarelto)
D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer

The purpose of this study is to evaluate the safety and the effect of D2 and D2+ radical surgery for the treatment of advanced distal gastric cancer.

To evaluate the safety and the disease-free survival time(DFS) and overall survival time(OS) of D2 and D2+ radical surgery for the treatment of advanced distal gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 18 to 70 years old.
* The preoperative evaluation: distal gastric cancer patients, ≥ T2 or N +; or staging II, IIIA, IIIB.
* Karnofsky score ≥ 70, life expectancy \> 6 months.
* Endoscopic biopsy diagnosis of gastric cancer, excluding non-Hodgkin's lymphoma, leiomyosarcoma and other mesenchymal tumors.
* the blood and biochemical indicators of the subjects must meet the following criteria: Hb ≥ 9 g / dl; WBC ≥ 4,000 / mm3, ≤ 12000 / mm3; PLT ≥ 100,000/mm3;
* GOT, GPT within twice the institutional limit,serum total bilirubin \< 1.5 times the upper limit of normal, serum creatinine\< 1.25 times the upper limit of normal
* have not received prior chemotherapy, radiotherapy and biological therapy. signed informed consent.
* must accept the standard D2 or D2 + radical gastrectomy.
* with good compliance.

Exclusion Criteria:

* pregnancy, breast-feeding women.
* allergy with chemotherapy drugs or metabolic disorder.
* the history of organ transplants (including bone marrow transplantation and autologous peripheral stem cell transplantation).
* had long received systemic steroid treatment (Note: short-term users of withdrawal \> 2 weeks can be selected.)
* The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders.
* patients with severe infection requires treatment.
* patients associated with dysphagia, active peptic ulcer, incompleteness intestinal obstruction, active gastrointestinal bleeding, perforation.

severe liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrollable diabetes.

* with other malignancies which were not cured.
* EKG abnormalities or heart disease with apparent clinical symptoms, including congestive heart failure, coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction. Coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction.
Functional Performance Following Emergency High-risk Abdominal Surgery

Emergency abdominal surgery is associated with high mortality rates, multiple postoperative complications and prolonged duration of hospital admission. The purpose of this study is to examine the postoperative functional performance in patients undergoing Emergency High-risk Abdominal Surgery. The hypothesis is that the study can describe the patient population in relation to postoperative functioning, degree of inactivity and the factors that limit mobility.


Eligibility Criteria:
Inclusion Criteria:

* Patients (19 years and older) undergoing emergency laparotomy or laparoscopy (inclusive reoperations after elective surgery).

Exclusion Criteria:

* Patients undergoing minor emergency operations (uncomplicated appendectomy, laparoscopic cholecystectomy, diagnostic laparoscopy or laparotomy without intervention)
Training Parenting Self-efficacy in Parents of Hospitalized Preterm Neonates

In a hospital environment, initial parenting of a family with a preterm neonate will be very different than expected. This unusual and stressful situation may determine the self-confidence perceived by mothers and fathers in caring their baby and therefore could shape future interaction with him/her as well as neurodevelopmental and behavioral development of preterm infants.

24/7 neonatal units allow parents stay with their baby whenever they want but this free access nor guarantee neither encourage parenting self-efficacy if it isn't hand in hand with a specific training program for parents.

Longitudinal, prospective, analytic cohort study of parents of preterm newborns who will receive a specific training program for caring their preterm newborns during hospitalization. Families will be recruited during the first 10 days of hospitalization. The PMP S-E (Perceived Maternal Parenting Self- Efficacy) tool developed by Barnes and Adamson-Macedo, will be used to measure self-efficacy in providing infant care by mother or both mother and father. The training program will be developed at bed side by nurses and neonatologist covering theoretical and practical sessions during the first 25 days of hospitalization.

Hypothesis principal: Parents of hospitalized preterm neonates will get better score after application of a specific training program (CAP-PREM).

Secondary hypothesis:

* There is a correlation between the level of stress and anxiety in parents at admission and discharge and the results of PMP S-E score after the CAP-PREM program
* To assess those selected demographic variables that can predict a better result in PMP S-E score after the CAP-PREM program

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants between 25 and 32 weeks of gestation,
* parents stay at the unit for at least 8 hours/day during training program
* fluent Spanish.
* parents age \> 18 years
* No clinical instability, invasive mechanical ventilation, intraventricular hemorrhage \>II or necrotizing enterocolitis .
* no congenital malformation nor chromosomal abnormalities

Exclusion criteria :

* No possibility of survival beyond the first week of life
* Admission less than 4 weeks
* No collaboration / lack of parental compliance
* wish of parents to leave the study
Development of a Multifunctional Rehabilitation Device for Persons With Parkinson's Disease

The researchers have developed a multifunctional rehabilitation device that will be tested in this feasibility trial across three sub-studies: (i) dual session in-lab; (ii) multi-session in-lab and (iii) in the participant's home. A long-term outcome is to test possible benefits of this device (if accepted by the user Parkinson population) on motor and cognitive functions in a clinical trial in a future study. Participants who receive a device during the in-home trial will have the option to keep the device for up to two years in an open label extension. During this extension, participants can optionally provide feedback on their user experience such as discomfort.

The primary purpose of this feasibility study is to assess human user acceptance of the device during 2 lab sessions (aim 1) from which the persons will proceed to 5 lab sessions (aim 2) and during in-home use (aim 3). The in-home aim will also include control persons to allow exploratory collection of clinical data that may provide preliminary outcome data to properly power a future phase 2 randomized clinical trial. The open label extension will provide information on the efficacy of using the device long-term.

While 45 persons may appear to be a larger than normal number for a device feasibility trial, because Parkinsons patients have a wide range of clinical symptoms, in order to acquire any meaningful data, some "spread" must be achieved. For example, 3 individuals in several different symptomatic categories. Further, there is some chance of attrition. Lastly, to be clear, details of device design may continue to be modified throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* Willing and able to comply with study requirements

Exclusion Criteria:

* Parkinson's disease dementia
* Parkinsonism plus syndromes
* Inability to stand, step, or walk without an assistive device
* History of symptoms in stance that preclude safe and comfortable participation, such as severe dizziness and lightheadedness, severe orthostasis, severe symptomatic leg or back musculoskeletal pain, painful neuropathy, significant ankle edema, or medication side effects
* History of symptomatic cardiovascular or pulmonary disease interfering with stance
* History of active rheumatic arthritis
* History of uncontrolled chronic pain syndrome
* Any other history of medical or psychiatric comorbidity precluding safe participation in the project
* Venous stasis or severe varicosities
Pre-hospital Notification of Injured Patients Presenting to Trauma Centres in India

A prospective observational study using an interrupted time-series design to evaluate the effect of pre-hospital notification on trauma patients arriving at a trauma centre by ambulance, in India

This is a longitudinal prospective cohort study of injured patients being transported by ambulance to the major trauma centre study sites. In the pre-intervention phase, prospective data on patients will be collected on pre-hospital assessment, notification, in-hospital assessment, management and outcomes and recorded in a new tailored multi-hospital trauma registry. All injured patients arriving by ambulance and allocated to a red or yellow priority category will be eligible for inclusion. The intervention will be a pre-hospital notification application in the form of an Android program that will be used by ambulance clinicians to notify emergency departments of selected hospitals of an impending arrival of a patient. The application will use a simple algorithm based on trauma triage principles developed by the Australia-India Trauma System Collaboration (AITSC). The proportion of severely injured patients arriving to hospital after notification will be the primary outcome measure with a target of 70%. Secondary outcomes evaluated will be availability of a trauma cubicle, presence of a trauma team on patient arrival, time to first chest x-ray and in-hospital mortality.

Eligibility Criteria:
Inclusion Criteria: All injured patients arriving by ambulance and allocated to a red (1st) or yellow (2nd) priority category will be eligible for inclusion. Data will be collected prospectively by trained data collectors positioned in the trauma centres.

Retrospective inclusion will be continued for all screened patients presenting to any of the included hospitals with injury (including near-drowning) as the primary diagnosis and with at least one of the following criteria:

1. Admission to hospital
2. Death after triage but before admission
3. Dead on arrival

Exclusion criteria: Patients meeting screening criteria will be subsequently excluded if they meet any of the following criteria:

1. Dead at scene
2. Alive at triage but not admitted to hospital (discharged alive)
3. Isolated poisoning
4. Isolated burns
5. Single digit finger or toe amputations (unless of the thumb or great toe), only
Effective Dose of Remimazolam Combined With Propofol in Painless Gastroscopy

This study used sequential method（Dixon's up and douwn） to determine the effective dose of remiazolam combined with propofol in painless upper gastrointestinal endoscopy

Remimazolam tosylate is a novel benzodiazepine drug that can be used for gastrointestinal sedation. However, some studies have reported that the sedative effect of using remimazolam alone is poor, and the patient's body movements are obvious, which affects the operation of endoscopists. Propofol, as a commonly used sedative drug, has good sedative effects, but has a high incidence of adverse events, especially cardiovascular system inhibition. Therefore, this study will explore the effective dose of remimazolam combined with propofol, reduce the adverse events of propofol and increase the sedative efficacy of remimazolam. This study only set up one study group, fixed the dosage of propofol, adjusted the dosage of Remimazolam to meet the appropriate sedation requirements for patients. Patients with successful sedation were judged to have a negative reaction, while patients with failed sedation were judged to have a positive reaction. A sequential chart was drawn based on the sedation situation until 7 positive negative reaction intersections were found, and the study ended

Eligibility Criteria:
Inclusion Criteria:

* ASA grading I to II, with a BMI of 18 to 30 kg/m2

Exclusion Criteria:

* Uncontrolled severe hypertension, previous history of abnormal anesthesia, unstable angina and myocardial infarction, abnormal liver and kidney function, acute upper respiratory tract infection, suspected difficulty in the airways, allergies to opioids, milk, eggs, and propofol, long-term use of sedative and analgesic drugs.
Diagnostic and Imaging Indicators of Immunocardiomyopathic Patients

Cardiac involvements in autoimmune diseases (AD) is common but underestimated and an early detection remains a clinical challenge for lacking of efficient imaging methods. The objective of the study was to investigate LV myocardial abnormalities in AD patients by multimodal cardiac imaging, including speckle-tracking echocardiology (STE), cardiac magnetic resonance imaging (CMRI) and positron emission tomography (PET).


Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed with autoimmune diseases, including systemic lupus erythematosus (SLE), vasculitis, dermatomyositis, sjogren's syndrome, scleroderma, rheumatoid arthritis and IgG4 associated disease.
* Patient is capable of complying with study procedures

Exclusion Criteria:

* Patient is pregnant or nursing
* Patient is complicated with congenital heart disease
* Patient had cardiac surgery before
* Patient is complicated with serious infections
* Patient is complicated with organ failure
* Patient is complicated with tumors
* Patient is diagnosed indefinitely
* Patient has been involved in other clinical trial
Phase II Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.

This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be refractory to one or two induction regimens, or have relapsed \< one year from the date of confirmation of the initial complete remission (CR). There will be two phases in this study - an Induction phase and a Consolidation phase.


Eligibility Criteria:
Inclusion Criteria:

* note: For inclusion and exclusion criteria, a regimen is defined as including Induction, Consolidation, and Maintenance therapies.
* Diagnosis of AML according to FAB classification
* Must not be eligible for therapy of higher curative potential, and must be in first or subsequent relapse and/or refractory
* A Karnofsky Performance Status (KPS) of greater than or equal to 60.
* If female of childbearing potential, patients must have a negative serum or urine pregnancy test within 7 days of study enrollment. Men and women with reproductive potential must use as an effective contraceptive method while enrolled in the study. Patients must have contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.
* Signed, written informed consent.
* Ability to comply with study procedures and follow-up examinations.
* Adequate organ function as indicated by specific laboratory values (defined in the protocol), obtained within two weeks prior to registration.
* Classified as AML FAB M3 (Acute Promyelocytic leukemia) and have been treated with at least 2 regimens (a retinoic acid containing regimen and an arsenic trioxide containing regimen) before being considered for this study.

Exclusion Criteria:

* note: For inclusion and exclusion criteria, a regimen is defined as including Induction, Consolidation, and Maintenance therapies.
* Received previous treatment with CLOFARABINE.
* Received more than two previous induction regimens or cycles for the treatment of AML.
* Relapsed \> 1 year.
* Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
* Are pregnant or lactating.
* Have psychiatric disorders that would interfere with consent, study participation or follow-up.
* Are receiving any other chemotherapy or corticosteroids. Patients must be off previous therapy for at least two weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment.
* Have any other severe concurrent disease.
* Have symptomatic CNS involvement.
* Have chronic myelogenous leukemia (CML) in lymphoid blast crisis).