cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Combination Therapy With Minocycline for Treatment of Stenotrophomonas Maltophilia Infections

The objective of the study is to evaluate the efficacy of minocycline for treatment Stenotrophomonas maltophilia infection. The hypothesis of study is the combination therapy with minocycline would be better than the monotherapy for treatment Stenotrophomonas maltophilia infection.

* Investigator inform patient or their relatives about all topics in project, eligible criteria, method, material and monitoring treatment.
* After patient or their relatives are appreciated to join this project, patients will be randomly allocated to either levofloxacin or cotrimoxazole plus placebo (monotherapy plus placebo) or levofloxacin or cotrimoxazole plus minocycline (combination therapy).
* Duration of treatment is determined by site and severity of infection, approximately 7-28 days.
* Sample size calculation, by two independent proportions formula, the investigators estimate the mortality rate about 54 % in monotherapy group and mortality rate about 27 % in combination therapy with minocycline group, with 2-sided 95% Confidence interval; therefore,51 persons are needed each group.
* The investigators estimate gather data about 112 persons. (56 participants with monotherapy and 56 participants with combination therapy (minocycline plus another antibiotic drug from intervention trial))
* The categorical variables are reported as frequencies and percentages, while continuous variables are reported as means ± standard deviations for normally distributed data and median ± range for non-normally distributed data. The data collected from patients are compared using Chi-square tests or Fisher's exact tests for categorical variables and using t-tests or Mann-Whitney U-tests for continuous variables.
* During the study is performing, all unexpected adverse event definitely report to Siriraj institutional Review Board immediately, in addition to subjects or their relatives.

Eligibility Criteria:
Inclusion Criteria:

* The infection caused by Stenotrophomonas maltophilia
* The duration of treatment approximately between 7-28 days
* The patients can take minocycline capsule via oral or nasogastric tube feeding.
* The patients are anticipated to live more than 48 hrs after participation.
* In case of an antibiotic drug administration for treatment Stenotrophomonas maltophilia beforehand, it should not exceed 48 hrs.
* All of participants should be willing to join this project.

Exclusion Criteria:

* Pregnancy and lactation
* The patients with active hepatitis
* The patients with history of minocycline allergy
The Impact of the Prevention Program Developed for Injuries in Recreational Cyclists

The aim of this study is to determine the effects of personal ergonomic adaptations of the bicycle on the bicycle performance parameters, together with the exercise program training created to prevent biomechanical problems that cause injuries in recreational cyclist.

Considering the pandemic period we are living in, people are much more interested in health, sports and nature than they used to be. From this perspective, the interest in cycling, which can accommodate all of these features at the same time, is rapidly increasing. Individuals take bicycle rides in nature in their free time and make this activity a way of life. However, as in every physical activity, factors such as lack of knowledge in cycling, choosing the wrong bike and material, and not knowing the important basics of sports cause non-traumatic injuries in cyclists.

While transitioning from the sedentary life brought by the age of technology to the activity, the musculoskeletal systems of individuals are caught unprepared and even exposed to various traumas and biomechanical problems. Because the looping motion of the lower extremities while cycling occurs primarily in the sagittal plane, power imbalances can develop that affect a cyclist's susceptibility to injury elsewhere along the kinetic chain. The most common areas of overuse injury in cycling are the knee, lumbar spine, cervical spine, hip, Achilles tendon, wrists, and forearm.

Eligibility Criteria:
Inclusion Criteria:

* Recreational cycling for at least 1 year
* body mass index between 18.5-25 kg / m²
* Obtaining a written health report stating "there is no harm in using a bicycle"

Exclusion Criteria:

* History of fracture, trauma or surgery in the last 6 months
* have any systemic or neurological problems
Healthsnap on Epicardial Adipose Tissue Study

The purpose of this research study is to learn about the effectiveness of HealthSnap assessment, to reduce epicardial fat thickness. Excessive epicardial fat is associated with higher risk of developing diabetes and heart diseases. HealthSnap Assessment is a simple, quick and not invasive tool that will provide the patient with a personalized information nutritional and exercise plan.The use of HealthSnap in the clinical practice has not been evaluated, yet.

This study will evaluate the practicality of adding the HealthSnap algorithm to the standard care of patients with overweight/obesity and pre-diabetes.

Participants will be recruited among the outpatient population who routinely refer to the Lennar Foundation Comprehensive Diabetes Center Outpatient Clinics, Division of Endocrinology, Diabetes and Metabolism University of Miami, for standard care and management of diabetes, obesity, overweight, hypertension, dyslipidemia.

Once patient eligibility and written consent are obtained, participant is then scheduled for the clinic visit through the University of Miami UChart (Epic) electronic system. The visits will be coordinated by the research coordinator. At each visit each patient will undergo:

* Full physical examination, body weight, height, waist and hip circumference, blood pressure (standard of care)
* Fasting blood glucose and haemoglobinA1c (HbA1c), lipid panel, comprehensive metabolic panel, fasting insulin, C-peptide and pro-insulin (all procedures are standard of care)
* Ultrasound assesment of epicardial fat, performed on site
* HealthSnap assessment performed on site (if randomized to the group receiving additional Healthnap)
* Standard of care dietary counselling performed on site by a registered dietitian (if randomized to the control group)

Study patients and controls will be contacted by the dietitian and/or HealthSnap supervisor once a week via telephone, or email (Uchart) or via online session (collaborate Ultra) to monitor their compliance and adherence to the exercise and dietary program.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥ 27 kg/m2
* HbA1c 5.7-6.5% within 3 months the initial visit and/or
* Fasting blood glucose (FBG) 100-125 mg/dl within 3 months the initial visit and/or
* Family history for diabetes or CAD or dyslipidemia

Exclusion Criteria:

* • Type 1 diabetes

  * Pregnancy
  * Mental illness preventing correct use of HealthSnap
  * Physical inability to follow HealthSnap recommendations
  * Active infective and neoplastic diseases
  * No current diabetes medications with the exception of Metformin
  * Chemotherapy
Acute Kidney Injury in Non-Critical Care Setting: Elaboration and Validation of an In-hospital Death Prognosis Score

Acute renal failure (AKI) is defined by a deterioration of kidney function over a short period. This definition was clarified recently in order to allow homogenization and optimal comparison of patients in clinical studies by the classifications RIFLE in 2004, AKIN in 2007 and KDIGO in 2013. These classifications decline several stages of ARI through the increase in the plasma creatinine level and the decrease in urine flow.

Even though AKI is a frequent pathology in all hospitalized patients, there are only few studies that are interested in this entity in conventional hospital services except intensive care or intensive care. Indeed, the recent meta-analysis including the 154 studies focusing on the ARI defined by the KDIGO criteria, only 7 have recruited patients in conventional nephrology services. However, patients admitted for an ARI which requires treatment in a medical service probably have epidemiological characteristics and a different prognosis than those requiring treatment in intensive care. In addition, the parameters of the RIFLE, AKIN or KDIGO scores are more difficult to establish in conventional hospital services than in intensive care, especially for hourly monitoring of urine flow, not allowing an optimal classification of the episode of IRA.

This study set out to develop a prognostic score for intra-hospital mortality in ARI based on a first historical cohort. The investigators then validated this score on a second prospective cohort obtained over an independent inclusion period and at a distance from the first.


Eligibility Criteria:
Inclusion Criteria:

* all patients over 18 years of age admitted for ARI, defined by an increase in serum creatinine of more than 50% of baseline serum creatinine in patients without chronic kidney disease or an increase in serum creatinine greater than 100 umol / L compared to baseline serum creatinine if the patient had a serum creatinine clearance less than 60 mL / min / 1.73m2 calculated by the MDRD formula (Modification of the Diet in Renal Disease), hospitalized in the Nephrology department of the Besançon University Hospital Center

Exclusion Criteria:

* kidney transplant and patients from an intensive care unit
A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients

To evaluate the efficacy and safety of azithromycin administered once a week in the prevention of disseminated Mycobacterium avium complex (MAC) in severely immunocompromised HIV-infected patients with a CD4 count \< 100 cells/mm3.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Required:

* Anti-pneumocystis prophylactic therapy (dihydropteroate synthetase inhibitors with or without dihydrofolate reductase inhibitors, pentamidine).

Allowed:

* Concomitant anti-HIV therapy (AZT, ddI, ddC) or antifungal therapy (including azoles).

Patients must have:

* HIV infection.
* CD4 count \< 100 cells/mm3.
* No MAC positive blood cultures within 1 month prior to study entry.
* No symptoms suggestive of disseminated MAC infection (including unexplained diarrhea, fever, and night sweats) within 1 month of study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Positive PPD within 3 months prior to study entry (negative PPD defined as \< 5 mm induration).
* Chest x-ray suggestive of any active disease, in particular tuberculosis.
* Known hypersensitivity to macrolide antibiotics.
* Any other acute clinical condition likely to interfere with completion of the protocol.
* Inability to care for self without considerable assistance and medical care.

Concurrent Medication:

Excluded:

* Other investigational new drugs (except for foscarnet or ddC) unless prior agreement has been reached between the investigator and the Pfizer project physician.
* Concomitant putative immunostimulants.

Patients with the following prior conditions are excluded:

History of MAC or Mycobacterium tuberculosis (MTb) infection.

Prior Medication:

Excluded within the past 4 weeks:

* Any putative anti-MAC therapies including rifampin, rifabutin, clofazimine, ethambutol, cycloserine, ethionamide, amikacin, and ciprofloxacin or other quinolones thought to be active against MAC.
MICHAEL Method- Fulfilling Individual Potential to Attain Excellence - as a Tool for Improving Metabolic Control and Quality of Life Among Adolescence With Type 1 Diabetes

Type 1 diabetes is the most common childhood disease. Treatment of diabetes requires personal checks of blood sugar levels, injecting insulin, changing eating habits and physical exercise, which requires a real change in the life of the child \& adolescent and can cause significant damage to the quality of life as well.

Compliance to treatment is a major challenge for all patients and mostly to adolescence, which often worsen their diabetes control at that age.

The Michael Method is a unique, holistic program to develop and realize an individual's emotional, intellectual and behavioral potential, which is based on the belief that every human being can excel in every field they choose. The method was developed in 1988 by a multi-disciplinary team of professional academic in Israel. Today the Israeli education system implements the method in Junior High Schools and High Schools in diverse educational sectors. The program is taught at many other various frameworks: teachers' continuing education programs, colleges, programs run by the Ministries of Defense and Social Welfare, the National Insurance Institute, the National Electric Corporation and in many other public and private frameworks.

The proposed study is aimed to assess whether the Michael Method can be used as a tool for improving metabolic control and quality of life among uncontrolled adolescence with type 1 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes at least 1 year prior to study inclusion
* 12-17 years old
* HbA1c \> 7.8%

Exclusion Criteria:

- Incapability to comply with all study requirements
Vitamin D Supplementation in Wheelchair Indoor Athletes

There is a high prevalence of vitamin D deficiency in Switzerland. In indoor-athletes as well as wheelchair users, vitamin D deficiency occurs even more often. It is well established that vitamin D deficiency has a negative effect on health. However, vitamin D supplementation in individuals with a vitamin D deficiency has a positive effect on muscle performance. In recently published studies with able-bodied subjects, it has been shown that a normal vitamin D level (\>75nmol/L) can only be achieved with a high-dose supplementation of vitamin D.

The aim of this study is to examine the effect of vitamin D supplementation on exercise performance in wheelchair athletes with vitamin D deficiency . All participants with a vitamin D deficiency are assigned to the intervention group and treated with 6000 IU of vitamin D3 daily over a period of 12 weeks. All participants who have a normal vitamin D level will receive placebo treatment (control group). The physical performance is measured three times at baseline, after six weeks and 12 weeks. The measurements include a Wingate and a dynamometer test.


Eligibility Criteria:
Inclusion Criteria:

* swiss elite wheelchair athlete
* 18 to 60 years
* male, healthy
* at least 2x45min sports a week

Exclusion Criteria:

* participation in another study
* medication which influences performance
* respiratory and cardiovascular disease
* daily intake of \>400IU Vitamin D
* parathyroid gland disease
* kidney insufficiency
* visit abroad below the 37th parallel latitude during study or shortly before
A 3-Month Non-Interventional Study of Asthmatics Treatment With Symbicort® Turbuhaler®

The purpose of this study is to investigate real practices of treatment with Symbicort Turbuhaler for 3 months in asthma and patient compliance.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Asthmatics who has been prescribed Symbicort according to physician's judgement
3. Usage of Symbicort should follow local prescribing information

Exclusion Criteria:

1. Not being involved in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
2. No previous enrolment in the present study
Developmental Epidemiological Study of Children Born Through Reproductive Technology

DESCRT will be a long-term study that both looks back in time, at successful pregnancies, and forward in time at early pregnancy and long-term as these children grow. Currently, there are limited data on the long-term effects of infertility and infertility treatments on children. There are some studies to suggest that these children may have altered metabolic profiles, but this study aims to be the largest study to answer this question.

Over the past 30 years, much of the research and clinical effort in the field of ART had to do with improving outcome in terms of successful pregnancy. However, as these rates have increased, attention is slowly turning to focus on the health of the resultant child. Short-term health complications, in particular birth defects,have been well-described. However, even this "hard" outcome has been difficult to characterize as studies used different methodologies, varied age of detection, and frequently didn't have an appropriate comparison group. When underlying parental factors and infertility are included in the analyses, the association is substantially weakened or disappears completely. This exemplifies the problems with much of the currently available research regarding childhood outcomes following ART. While the health of children born through these technologies is of critical public health interest, and of personal interest to families, only limited data exist.

In order to evaluate the potential risk to long-term health of children conceived through assisted reproductive technologies (ART) and non-IVF fertility treatments (NIFT), rigorous epidemiological methods, appropriate characterization of the exposure, standardized collection of outcome data, and appropriate comparison groups are required. The proposed Developmental Epidemiological Study of Children born through Reproductive Technology (DESCRT) is aimed to carefully address these important characteristics.

Eligibility Criteria:
Retrospective arm

Inclusion criteria:

- children conceived by parent(s) who sought evaluation/treatment for infertility

Exclusion criteria:

- Children with chronic medical illnesses that prevent a study visit

Prospective arm

Inclusion criteria:

- seeking evaluation/treatment for infertility

Exclusion criteria:

- none
Goal-directed Analgesia Using ANI During General Anesthesia in Children With Moyamoya Disease

Analgesia Nociception Index (ANI) has been proposed for the evaluation of the nociception-antinociception balance in the perioperative period. In pediatric patients with Moyamoay disease, where the management of analgesia may be rendered difficult by pharmacological changes, we hypothesised that the monitoring of analgesia with ANI would reduce intraoperative opioid consumption during EDAS surgery.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients receiving EDAS surgery for Moyamoya disease

Exclusion Criteria:

* ASA (American society of anesthsiologists classification) 4-5
* Emergency surgery
* patients with chronic pain on medication
Pathological Type，Gene Mutation and Clinical Characteristics of Unilateral Primary Aldosteronism

1. Aim to investigate the pathological feature of UPA in Asians
2. To clarify the relationship between pathology, clinical phenotype, genetic mutation and surgical outcome of UPA in Asians.
3. To explore a new pathological type of unilateral primary aldosterone

The multi-center expert team led by Tracy Ann Williams formulated the International Consensus on the Pathological Diagnosis of Unilateral aldehyde disease, which standardized the pathological classification of unilateral PA. The previous retrospective study of the research group found that the pathologic types of unilateral primary aldosteronoma were mainly classical, and aldosteronoma was the most common. There was no significant difference in clinical features and postoperative biochemical remission rate between patients with classic and non-classic, but the clinical prognosis of the latter group was worse than that of the classical group. However, the study was retrospective and there may be inclusion bias. The pathologic distribution and clinical features of unilateral aldehyde disease are not completely clear and need to be discussed in prospective studies.Therefore，this study aims to determine the composition ratio of different pathological types in patients with unilateral procaldosis enrolled in our center. Gene mutation of different pathological types, the relationship between pathology and clinical phenotype, gene mutation, etc.

Eligibility Criteria:
Inclusion Criteria:

1. No gender limitation;
2. Age 18-80 years old;
3. The patient was diagnosed with UPA and underwent total adrenal resection.

Exclusion Criteria:

1. Bilateral disease
2. Partial of no biochemical response in follow-up
3. partial adrenalectomy
WISER After Ovarian Cancer - Exercise Pilot Study

One in four deaths in the United States is due to cancer, and one in three women will develop cancer in her lifetime. Despite improvements in survival among other forms of cancer, ovarian cancer prognosis remains poor. Eighty percent of women with ovarian cancer will present with advanced disease (stage 3 or 4) where 5-year survival ranges from 18-34%.2 Among patients with stage III and IV epithelial ovarian cancer (EOC), recurrence rates are high.4 Therefore, interventions focused on preventing recurrence or slowing progression of EOC is a critical problem in the field. The investigators have submitted an R21 to NCI for a dose response exercise intervention trial to examine the dose response effects of aerobic exercise on biomarkers relevant to ovarian cancer progression and recurrence. The reviewers would like assurance that the investigators can recruit ovarian cancer patients into an exercise study and that these women will do the exercise protocol we plan to prescribe in our high dose of exercise.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage III-IV EOC, completed surgery,
* \> 12 months life expectancy (physician estimate),
* able to walk 15 minutes at a time (use of a cane is acceptable).

Exclusion Criteria:

* medical or psychiatric conditions (beyond ovarian cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e.g. cardiac, pulmonary, or
* orthopedic history that would prohibit a program of walking for exercise;
* psychotic disorders,
* dementia,
* inability to give informed consent
Meal Delivery and Exercise

The purpose of this study is to evaluate the effects of a home-based exercise program administered through Meals on wheels (MOW) on gait speed and frailty status and to assess the association between novel serum biomarkers (70 kilodalton heat shock proteins (HSP70),Macrophage Inflammatory Proteins(MIP1b), soluble IL-6 receptor alpha-chain (sIL-6R)) and established but non-specific frailty biomarkers (Interleukin 6 (IL-6), C-reactive protein (CRP), Tumor necrosis factor (TNF-α)) in frail and prefrail homebound older adults before and after the exercise intervention.


Eligibility Criteria:
Inclusion Criteria:

* homebound (normally unable to leave the home unassisted)
* frail or prefrail by The Fried Frailty Phenotype (FFP)
* medically stable

Exclusion Criteria:

* robust by FFP
* have Mini-Cog score \<3 and/or are unable to follow instructions
* have a pre-diagnosed terminal illness
* unable to ambulate
* unable to use their upper extremities, and/or are already participating in physician-prescribed physical therapy or occupational therapy.