cyrilzakka/clinical-trials huggingface dataset:
The Examination of Relationship Between Self-Efficacy in People With Chronic Low Back Pain

Self-efficacy is defined as a person's confidence or belief that one can achieve a certain behavioral or cognitive state. Self-efficacy is one of the most important assesment parameters in the self-management model. It is accepted that patients with chronic low back pain with high self-efficacy have a better prognosis than those with low self-efficacy. Due to the complex nature of pain; The relationship between psychological and physical parameters such as pain catastrophy, disability level, depression, physical performance, self-efficacy, pain intensity and fear avoidance arouses curiosity. The aim of this cross-sectional study is to examine the relationship between the level of self-efficacy and sensory, perceptual and motor skills in people with chronic low back pain.


Eligibility Criteria:
Inclusion Criterias For Healthy Group:

* Being minimum 30 maximum 65 years old
* To be literate
* Accepting to take part in the study

Inclusion Criterias For Partipicians with Low Back Pain Group:

* Being minimum 30 maximum 65 years old
* Minimum 3 score from Visual Analog Scale (VAS)
* Having low back pain for at least 3 months of time
* To be literate
* Accepting to take part in the study

Exclusion Criteria:

* Any kind of surgery in low back area
* Surgery story in lower extremities
* Acute low back pain
* Having a neurological disorder
* Having a rheumatological disease which may cause to low back pain
* Having a herniated disc that presses on the sacral nerves
* Being pregnant
Pharmacokinetic of Ceftriaxone in Septic ICU Patients

Ceftriaxone pharmacokinetics variability in intensive care unit septic patients

In intensive care units, drug dosage is often based on study made on healthy volunteers or on less severe patients.

However, pharmacokinetic alterations have been described for some drugs used in intensive care units.

These alterations, consequences of alteration of volume of distribution, of protein concentrations, of impaired hepatic and renal functions can result in accumulation with toxicity or " under dosage " with inefficacity.

Ceftriaxone is an antibiotic often prescribed in intensive care unit. However, despite this large utilisation, very few data is available on the pharmacokinetic in intensive care unit, and optimal dosage is not known.

Our objective is to develop a population pharmacokinetics model of ceftriaxone in intensive care unit patients with sepsis, severe sepsis and septic shock and to identify the " data " explaining interindividual variability of each pharmacokinetics parameter.

This is a one centre population pharmacokinetics non interventional study. One group of 50 patients allows the development of the model and a second group of 20 patients will be used for the validation of the model.

Septic patients treated with ceftriaxone according to standard procedure of our ICU could be included before the second administration of the drug. In the development group, patients will underwent five determination of serum concentration of ceftriaxone during the 24 hours following the second administration. The timing of samples will be randomised in three groups. A second phase of sampling will take place during the fifth day of ceftriaxone therapy for sepsis and severe sepsis patients and after 48 hours catecholamine- free for septic shock patients.

For the validation group, ten samples will be obtained at the same periods. This study will not induce any change in the care of patients.

Samples will be centrifugated immediately after collection and conserved at - 20 °C.

Ceftriaxone will be assayed in the department of pharmacology, university of Marseille France, usig HPLC method.

Pharmacokinetic analysis will used NONlinear Mixed Effects Modelling logiciel

Eligibility Criteria:
Inclusion Criteria:

* Eighteen-year or more
* sepsis, severe sepsis or septic shock (according to Bone's criteria)
* admission to intensive care unit
* informed consent obtained
* affiliation to medicare

Exclusion Criteria:

* Previous haemodialysis
* hemopathy
* known allergy to cephalosporin
* patients whose death is considered imminent
A Dose-response Study of Dietary Resveratrol on Lipid Metabolism Disorder

In order to study the effect of resveratrol on the improvement of lipid and uric acid metabolism, randomized intervention trials were conducted to compare the effects of resveratrol on the improvement of lipid and uric acid metabolism in different dose groups. To explore the best dose of resveratrol for the prevention and treatment of metabolic diseases provide an important scientific basis.

In order to study the effect of resveratrol on the improvement of lipid and uric acid metabolism, randomized controlled trials were conducted to enrolled 160 patients with dyslipidemia. The subjects were divided into 0 mg / d, 100 mg / d, 300 mg / d, 600 mg/ d four dose groups, intervention for 8 weeks, comparing different doses of resveratrol on lipid and uric acid metabolism. To explore the best dose of resveratrol for the prevention and treatment of metabolic diseases provide an important scientific basis.

Eligibility Criteria:
Inclusion Criteria:

* Dyslipidemia
* The age between 35 and 70 years old

Exclusion Criteria:

* Intake of any medicine that affect lipid metabolism currently or in the preceding 6 months
* Dietary supplementation with phytochemicals including resveratrol in the preceding 3 months
* History of acute or chronic infectious disease, autoimmune disease, cancer, traumatic injury, or surgery in the preceding 1 month
* History of severe chronic disease including AS and CVD, liver or renal dysfunction, and lactation or pregnancy
* Pregnant woman and Breast Feeding Women
High Flow Nasal Cannula Versus Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation

The primary objective is to determine whether High Flow Nasal Cannula (HFNC) is a superior respiratory modality for neonates ≥36 weeks with transient tachypnea of the newborn (TTN) when compared to the standard of care modality (NCPAP).

Transient Tachypnea of the Newborn, fetal lung fluid retention causing poor lung compliance and atelectasis, is a common entity in neonates ≥ 36 weeks in our unit. Currently our standard of care includes using the respiratory modality of bubble nasal continuous positive airway pressure (BNCPAP) to support these neonates during this illness. BNCPAP provides positive distending pressure to recruit alveoli and prevent atelectasis, however, it is associated with air leak (pneumothorax, pneumomediastinum), nasal irritation and necrosis, and intolerance. HFNC is another respiratory modality that uses high flow gas that also provides positive distending pressure and thus prevents atelectasis. This modality does not cause nasal irritation or necrosis and has a minimal risk of air leak. We postulate that HFNC is a superior modality to BNCPAP in treating neonates ≥ 36 weeks with TTN. This will be determined by comparing the duration of respiratory support (in hours) for newborns ≥ 36 weeks gestation with a diagnosis to TTN randomized to receive either NCPAP or HFNC for respiratory care.

Eligibility Criteria:
Inclusion Criteria:

* gestational age ≥ 35 weeks
* diagnosis of TTN, defined as respiratory rate \>60, presence of subcostal and /or intercostal retractions, nasal flaring, grunting, oxygen saturations 70-93% on room air, and radiological evidence of perihilar streaking and patchy infiltrates
* admission to the NICU at Mount Sinai hospital within first 24 hours of life

Exclusion Criteria:

* gestational age \< 35 weeks
* history of thick meconium stained fluid and/or diagnosis of meconium aspiration syndrome
* diagnosis of major congenital pulmonary or cardiac anomalies
* initial CXR demonstrating air leak
* respiratory distress first occurring after 24 hours of life
* presumptive diagnosis of RDS as indicated by the need for FiO2 \> 40%, severe retractions and grunting with poor air entry, and diffuse alveolar consolidation on chest radiograph
A Study to Evaluate the Effect of ATG-F on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical SCT

This study is planned to evaluated whether ATG is needed in haploidentical stem cell transplantation


Eligibility Criteria:
Inclusion Criteria:

1. Patient age 3-70 years old with a disease necessitating allogeneic SCT.
2. Patients must have a mismatched donor willing and capable of donating peripheral blood stem cells and/or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (mismatched defined as 3/6-4/6 HLA matching).
3. Each patient / patient's guardian must sign written informed consent.
4. Patients must have an ECOG PS ≤ 2; Creatinine \<2.0 mg/dl; Ejection fraction \>40%; DLCO \>50% of predicted; Serum bilirubin \<3 gm/dl; elevated GPT or GOT \>3 x normal values.

Exclusion Criteria:

1. Not fulfilling any of the inclusion criteria.
2. Active life-threatening infection.
3. Overt untreated infection.
4. Known hypersensitivity to ATG.
5. HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
6. Pregnant or lactating women.
7. Donor contraindication (HIV seropositive confirmed by Western Blot Hepatitis B antigenemia; positive HCV antibodies with positive HCV PCR; evidence of bone marrow disease; unable to donate bone marrow or peripheral blood due to concurrent medical condition).
8. Inability to comply with study requirements.
Reproductive Health in Men and Women With Vasculitis

The purpose of this study is to learn about reproductive health, including fertility and pregnancies, in people with vasculitis.

All patients enrolled in the Vasculitis Clinical Research Consortium's Contact Registry were invited via email to participate in this study. The Contract Registry includes people who self-identify as having one of 6 vasculitities: Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosum, Takayasu's Arteritis, and Giant Cell Arteritis. People voluntarily enroll in this Registry with the understanding that they will receive information about clinical studies for which they might be eligible. The introductory email included basic information about the study and all of the required elements for informed consent in a brief format. By clicking the link to the reproductive health questionnaire, participants gave their consent to be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in VCRC Contact Registry
* Patient reported diagnosis of Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa, Takayasu's Arteritis, Giant Cell Arteritis, Behcet's Disease, Kawasaki Disease, Henoch-Schoenlein Purpura, CNS or Drug-induced Vasculitis
* 18 years of age or older
* English speaking

Exclusion Criteria:

* Inability to provide informed consent and complete survey
Shifts in the Respiratory Microbiome and Clinical Outcomes of SARS-CoV-2

This is a longitudinal, prospective observational study focusing on health-related outcomes relative to potential changes in the respiratory microbiome seen with weekly SARS-CoV-2 testing in nursing home residents.

This study targets the influence of SARS-CoV-2, and the presence of mixed/co-infections on the respiratory microbiome. Their interrelationship will be characterized in a prospective observational study design. The observed changes will be correlated to medical (FEV1, CXR/CT, mortality, morbidity, symptoms) and clinical laboratory parameters (hematology, coagulation, bacterial/viral detection). The study aims at the detection of significant changes in microbiome in the respiratory tract following incidence of SARS-CoV-2 infection. These alterations in the respiratory microbiome will be determined by shotgun metagenomic sequencing. Ultimately, this can provide a better understanding of how SARS-CoV-2 and the presence of other bacteria and viruses affect the composition of the respiratory microbiome and a description of the microbiological etiology of these respiratory tract infections.

Eligibility Criteria:
Inclusion Criteria:

* All residents of the nursing home facility, (M/F) 65 years or above, who have recently tested positive through Ohio's PARRT Program are eligible
* Resident must submit weekly nasal swab sample per nursing home COVID testing guidelines
* Clinical suspicion of a new episode of acute respiratory tract infection.
* Laboratory confirmed SARS-CoV-2 infection by either a laboratory test, PCR or any other commercial or public health test

Exclusion Criteria:

* Nursing home residents that are not taking part regularly in weekly screening for SARS-COV-2 or residents that test negative through Ohio's PARRT program cannot be included as part of study analyses
* Residents on hospice, residents currently intubated, residents with scheduled transfer to another nursing home facility will not be included in study analyses
Soy Peptide, Conjugated Linoleic Acid, Overweight or Obese, Body Composition

Soybean peptides are a mixture of active peptides obtained from the hydrolysis of soybean protein, which have biological activities such as antioxidant, blood pressure lowering, anti-fatigue and lipid lowering, etc. They can regulate food intake, increase satiety, and reduce fat body ratio by reducing cholesterol and triglyceride content and stimulating CCK secretion.Conjugated linoleic acid (CLA) is a set of linoleic acid with conjugated unsaturated double bond, the location and structure of the isomers have been approved by the ministry of health in China as a new resource food , widely used in areas such as health care products, functional foods and food additives, animal experiments showed that it has reduce tumor, atherosclerosis, obesity risk.Therefore, in this study, the effect of conjugated linoleic acid combined with soybean peptide on overweight and obese people was investigated in a randomized controlled manner.

Aim 1: To test the effects of combined supplementation of soybean peptide and conjugated linoleic acid on body fat, liver fat and muscle content of overweight and obese people;Aim 2: To test the effects of combined supplementation of soybean peptide and conjugated linoleic acid on blood lipid, blood glucose, fat or inflammatory factors in overweight and obese people; Aim 3: Test the impact of the above interventions on safety indicators (safety indicators: liver and kidney function, self-reported adverse reactions or diseases). Aim 4: To provide scientific basis for the development of functional food for weight loss and muscle gain.The public health significance of this research is that find a new functional food for weight loss and muscle gain.

Eligibility Criteria:
Inclusion Criteria:

* Age - 18-65 years old;
* Gender-not limited;
* BMI-24-35 kg/m2;
* Body fat rate-Male ≥25%, female ≥30% (body fat meter can be used for screening, DXA is used for diagnosis);
* Waist circumference: male \>90cm, Female\>80cm (not required).

Exclusion Criteria:

* Suffer from serious diseases such as heart, liver, kidney, brain, hematopoietic, immune, thyroid, malignant tumors;
* Take drugs or supplements that have a known effect on body fat and muscle mass;
* Those whose weight has changed more than 10% in the past 3 months;
* Those who have cognitive or mental disorders and cannot conduct questionnaire surveys;
* People who are physically disabled and cannot walk normally;
* Those whose compliance with the pre-experiment period cannot meet the requirements;
* Fail to sign the informed consent form, or other researchers think it is not suitable for participants
Effects of Myofascial Release in Cerebral Palsy Children

Cerebral palsy (CP) is a common disorder which leads to physical disability in children throughout life and begins in early childhood. In cerebral palsy spasticity is considered as a primary factor leads to much impairment which is inversely related to functional development that means greater the spasticity lowers the level of function. There are many ways to treat spasticity which involve stretching, strengthening, postural education, neuromuscular electrical stimulation, cryotherapy and myofascial release technique.

This study will be a randomized controlled trial. Study will be approved by ethical committee. After that informed consent will be taken and patients will be included in the study on the basis of inclusion criteria. Non probability convenience sampling technique will be used and study will be conducted on 28 patients with spastic hemiplegic cerebral palsy, 6 to 12 years of age. Patient will be randomly categorize into two groups by using flip coin. Experimental group will receive myofascial release on ankle planterflexors and quick icing treatment protocol on ankle dorsiflexors. Control group will receive only myofascial release treatment protocol on ankle planterflexors. Pre and Post intervention assessment will be made for both groups. Tone of planterflexors will be assessed by Modified Ashworth Scale, ankle passive range of motion will be assessed by goniometer and static balance will be assessed by Romberg test(open eyes).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with hemiplegic cerebral palsy
* Both genders
* Age between 6 to 12 years
* GMFCS Level I and II
* Modified Ashworth scale (grade1 - grade 3

Exclusion Criteria:

* Hypersensitive to cold
* Underwent any corrective surgery
* Specific perceptual and cognitive impairments
* Subjects who has received Botulinium toxin injection in the past 6 months
How to Dose a Patient According to Renal Function? Glomerular Filtration Rate (GFR) or Creatinine Clearance (ClCr)

Background： The prevalence of chronic kidney disease (CKD) is high in Taiwan. Though there are many factors that may affect the measurement of serum creatinine, it is a well-accepted marker for renal function assessment. The creatinine clearance (ClCr) estimated by Cockcroft-Gault is commonly used as a reference for dosage adjustment; while the estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) is used in CKD staging. ClCr and eGFR not only have different units, but the results of estimation from the two varied among races and individuals. Since 2010, US Food and Drug Administration required both the influences of ClCr and eGFR on the pharmacokinetics of a drug in renal insufficient patients during pharmacokinetic studies. Because most drugs are excreted through kidney, an understanding on the relationship between ClCr and eGFR is important to dose safely and effectively. Furthermore, identifying the factors that may influence the difference between ClCr and eGFR can provide in-depth consideration during clinical renal function assessment.

Purpose： The purpose of this study is to analyze the correlation between different ClCr and eGFR equations in order to provide better renal dose. We also want to find the factors that may cause the differences between them.

Methods： This study will conduct literature review to understand study population during the development of different ClCr and eGFR equations, as well as their scope of application. National Taiwan University Hospital electronic patient database will be used to analyze the correlation between ClCr and eGFR and to identify factors that may influence the difference between ClCr and eGFR. The data from patients who have completed 12-hr or 24-hr urine collection with calculated renal function will be used to verify the applicability of these equations (including a ClCr equation developed by our institute) in Taiwanese. Pharmacokinetic principles will be used to analyze the appropriate unit to be used for renal function while dosing a patient.


Eligibility Criteria:
Inclusion Criteria:

* adult patients with serum creatinine test result

Exclusion Criteria:

* unstable renal function, hemodialysis, cachexia, pregnancy, severe burn, muscle atrophy, severe trauma, amputation, liver failure
Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with glioma. Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if standard radiation therapy is more effective when followed by stereotactic radiation therapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with or without stereotactic radiation therapy in treating patients who have glioma.

OBJECTIVES: I. Compare the effect of adjuvant conventional radiotherapy with or without fractionated stereotactic boost radiotherapy on survival in patients with high grade glioma. II. Compare the quality of life of these patients after these therapies.

OUTLINE: This is a randomized study. Patients are stratified according to WHO disease grade (III vs IV), center, and age (under 40 vs 40 and over). Patients are randomized to undergo stereotactic radiotherapy or no further treatment after conventional radiotherapy. Patients undergo conventional radiotherapy once or twice a day for up to 6 weeks. Patients randomized to receive additional treatment receive stereotactically guided conformal boost radiotherapy for 4 days, within 4 weeks after completion of conventional radiotherapy. Quality of life is assessed before radiotherapy, then at follow up visits. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 605 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven WHO grade III or IV glioma at primary diagnosis that enhance on preoperative imaging Glioblastoma Anaplastic astrocytoma Gliosarcoma Tumor volume no greater than 4.0 cm in maximum diameter on preoperative CT or MRI No prior histology of WHO grade I or II glioma Astrocytoma Oligodendroglioma No brainstem or infratentorial tumor No multifocal glioma Safe to treat tumor stereotactically No close proximity to critical structures, e.g., optic chiasm

PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: WHO 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Able to tolerate full course of conventional radiotherapy No prior or concurrent medical condition that would preclude study therapy No prior malignancies within 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No concurrent adjuvant chemotherapy Endocrine therapy: Concurrent steroids allowed Radiotherapy: See Disease Characteristics No prior radiotherapy to the head and neck area No prior radiotherapy to the brain No more than 6 weeks since other prior radiotherapy Surgery: See Disease Characteristics