cyrilzakka/clinical-trials huggingface dataset:
Creatine Supplementation in Female Collegiate Dancers

This study will be a 6 week creatine supplementation intervention with performance familiarization and pre and post testing. Participants will report to the human performance laboratory (HPL) for baseline to read and sign an informed consent explaining the procedures and potential risks and benefits of participation. Participants will then complete a physical activity readiness questionnaire (PAR-Q) prior to performing any physical tasks. Participants will also be asked to complete testing below in the order described. Participants will become familiar with the pre/post performance tests, which include isokinetic testing, medicine ball throw, vertical jump, and Wingate testing. Twenty-four hours following visit 1, participants will return to the HPL for visit 2 where they will undergo a second familiarization session for the isokinetic testing and Wingate testing only - these two tests require individuals to provide maximal physical efforts and research suggests that participants should perform multiple familiarization trials before beginning experimental trials. At least 72 hours following visit 2, participants will return to the HPL for visit 3 to perform the baseline performance assessments. Following the baseline assessments, participants will be divided into two supplementation groups: creatine and placebo (maltodextrin). These groups will be randomized and matched based on body mass, hours of dance training per week, meat intake, and menstrual cycle phase. Participants will be asked to consume one of the two supplements daily for 42 consecutive days and maintain their regular dance training and eating behaviors. Participants will report to the HPL daily to receive their supplement between the hours of 12pm and 2pm. Following the last day of supplement consumption, participants will report to the HPL to perform post-testing assessments which will be identical to pre testing.


Eligibility Criteria:
Inclusion Criteria:

* Collegiate dance major or minor

Exclusion Criteria:

* Injured within the past 6 months
* Currently consuming creatine supplements
Closed Suction Drain or Not After Total Hip Arthroplasty

Comparative randomised study to clarify which better to use or no use of closed suction drain system after total hip arthroplasty regarding amount of blood loss, need for blood transfusion, risk for superficial infection, ecchymosis, wound discharge, effect on early post-operative rehabilitation. Patients will be followed up for one month postoperative clinically (Harris Hip score system), laboratory (Hb level), and radiologically (A-P view plain x-ray of the hip).

Total Hip Arthroplasty (THA) wounds are prone to formation of hematomas. Hematomas may increase the incision tension, leading to wound discharge and providing a good medium for bacteria, increase post-operative pain, limitation of range of motion of hip joint and prolong post-operative rehabilitation duration, also may cause ecchymosis, and tension vesicles around the surgical wound.

So use of closed suction drain system may reduce these complications. Nevertheless some recent studies have claimed that drainage can cause other complications and does not reduce hematoma formation and risk for infection. Furthermore, some studies have shown that drainage increase blood loss after THA which may both lead to increase blood transfusion requirements and provide an entry point for skin microorganisms.

Some other studies have found that no significance between use and non use of suction drain after THA.

So the investigators will take this issue for study a comparison between benefits and hazards of use and non use of suction drain after THA.

Eligibility Criteria:
Inclusion Criteria:

* Primary total hip arthroplasty (THA)

Exclusion Criteria:

* Revision cases
* Uncontrolled bleeding tendency (prothrombin conc. Less than 70%)
* History of deep venous thrombosis
* Sever liver impairment (liver failure)
* Sever renal impairment (S. creatinine more than 3)
Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy

Comparison of the effectiveness: Quadratus lumborum (QL) block by levobupivacaine with placebo.

All patients will receive standard anaesthesia using fentanyl, protocol, cisatracurium and sevoflurane. Prevention of nausea and vomiting is performing using Apfel score.

All patients will receive post operative multimodal analgesia using paracetamol, ketoprofen, tramadol, and trimeperidine if numerical rating scale \> 3 The study assumes use of QL block by levobupivacaine.in comparison with placebo in order to demonstrate the effectiveness of QL block during the operation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone left-sided or right-sided laparoscopic hemicolectomy.
* Patient's willingness and ability to sign an informed consent document

Exclusion Criteria:

* Allergy to local anesthetics
* Chronic pain syndrome and associated opioid use.
* Coagulopathy
* Uncontrolled diabetes mellitus
* Physical Status Classification System scale above 3
* Diseases associated with the pathology of the hypothalamus
* Diseases associated with the pathology of the pituitary gland
* Diseases associated with the pathology of the adrenal glands
Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients

The Ministry of Health has set the target of eradicating hepatitis C (HCV) in France by 2025.

The goal is to validate the feasibility and value of conducting routine HCV screening in hospitalized patients.

The number of undetected HCV-infected persons has been extrapolated to 75,000 according to the results of a 2014 study. Screening efforts have been set up in groups of people said to be at high viral risk: drug users, prisoners, precarious persons or migrants from highly endemic countries. Nevertheless, the concept of universal screening has not yet been adopted by the guardians and the Ministry.

It is in this context that "hepatitis free hospital" projects have been carried out in several French cities such as Nice, Nancy and Marseille.

The aim of the HOSPI-VHC study is to evaluate the feasibility and efficiency of systematic HCV screening in all medical and surgical departments of 4 National Association of Hepato-Gastroenterologists of General Hospitals (ANGH) hospitals. This pilot project is part of a public health screening program. It will evaluate the interest and usefulness of implementing universal screening in hospitalized patients without taking into account the existence of viral risk factors. This study will also make it possible to evaluate the implementation of a dedicated care pathway: number of patients screened, number of patients referred for consultation and number of patients accepting the consultation.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Hospitalized during the study period
* Non-opposition for participation in the Protocol

Exclusion Criteria:

* Patients under 18 years of age
* Outpatient, long-stay, maternity and intensive care inpatients
* Patients refusing blood collection
* Patient may not understand the information sheet
* Patient under guardianship
Together Everyone Achieves More (TEAM) Trial

The Together Everyone Achieve More (TEAM) Physical Activity trial evaluates the efficacy of a group-based social affiliation intervention (vs. a standard group-delivered physical activity comparison program) for increasing physical activity among inactive African American women. Using a group cohort randomized design implemented at community centers across five years, the primary aim of this study is to evaluate the efficacy of the 10-week TEAM-PA group-based intervention (vs. comparison program) on increasing daily total physical activity from baseline to post-intervention and maintenance at a 6-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* self-identifying as an African American or Black female
* engaging in \< 60 minutes of moderate to vigorous physical activity per week for the last three months

Exclusion Criteria:

* having a cardiovascular or orthopedic condition that would limit physical activity (including walking with a cane/walker)
* currently pregnant or planning to become pregnant in the next 2 months
* uncontrolled blood pressure (systolic \>180 mmHg/diastolic \> 110 mmHg)
HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin compared with HAIC of oxaliplatin alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).

Sorafenib is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients with portal venous tumor thrombus (PVTT). Our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to HCC with major PVTT. However, HAIC of fluorouracil is not such for advanced HCC. Whether HAIC of oxaliplatin is as effective as HAIC of oxaliplatin plus fluorouracil/leucovorin is controversial. Thus, the investigators carried out this prospective randomized control study to find out it.

Eligibility Criteria:
Inclusion Criteria:

The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)

* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* diagnosed with major or main portal vein invasion (Vp3 or Vp4)
* KPS≥70；
* with no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:
* Platelet count ≥ 75,000/µL
* Hemoglobin ≥ 8.5 g/dL
* Total bilirubin ≤ 30mmol/L
* Serum albumin ≥ 30 g/L
* ASL and AST ≤ 5 x upper limit of normal
* Serum creatinine ≤ 1.5 x upper limit of normal
* INR ≤ 1.5 or PT/APTT within normal limits
* Absolute neutrophil count (ANC) \>1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
* Serious non-healing wound, ulcer, or bone fracture
* Known central nervous system tumors including metastatic brain disease
Serological Evaluation of Varicella and Hepatitis A Vaccines Using Injector Delivery

This study aims to assess immunogenicity and safety of nd influence of the delivery system (needle-free injector or syringe with needle) of fractional doses (dose sparing) of two vaccines (Varicella and Hepatitis A vaccines) in children aged 13 to 30 months.

The purpose of this study is to evaluate the immunogenicity, safety and influence of the delivery system (needle-free injector or syringe with needle) of fractional doses (dose sparing) (23,3 and 43,3 PFU - plaque-forming units - of live attenuated OKA strain of Varicella-zoster virus and 100 radioimmunoassay units HAV) of chickenpox and Hepatitis A ( vaccines, intradermally administered, compared with full dose of 103,3 PFU, subcutaneously administered, in 600 primo (first) vaccinated children aged 13 to 30 months selected at random at day care centers in São Paulo. Vaccines will be tested sequentially (Varicella on day 0 and Hepatitis A on day 45). Only 400 children will be randomized again for Hepatitis A vaccine testing, the remaining 200 children will receive the regular dose of Hepatitis A vaccine without further assessment. Doses will be administered using two systems: Disposable Needle-free Syringe Jet Injector (DSJI), compared with the conventional procedure using syringes and needles. Serial blood samples will be blindly analyzed to detect antibody seroconversion. Local and systemic adverse events will be assessed according to definition established by Brighton Collaboration Group, 24 and 72 hours, 7 days, 14 days, 21 days and 45 days after each vaccination, through clinical evaluation and telephone calls.

Eligibility Criteria:
Inclusion Criteria:

* Children of both genders older than 13 months and younger than 30 months of age.
* Available for follow-up for at least 45 days at public day care centers funded by São Paulo City local government.
* Written informed consent signed by parents or legal guardians after reading and explanation

Exclusion Criteria:

* Suspect/verified diagnosis of congenital or acquired immunodeficiency syndrome (AIDS)
* Suspect/verified diagnosis of malign neoplasia
* Children on treatment with high-dose systemic corticosteroids (equivalent to prednisone 2 mg/kg/day, for two or more weeks), or immunosuppressive therapy.
* Received a vaccine with live attenuated strain of virus within less than 30 days
* Suspect/verified diagnosis of chickenpox or has already been immunized against chickenpox (varicella).
* Suspect/verified diagnosis of hypersensibility to any ingredient of the vaccine.
* One of the parents or legal guardians of the minor does not agree with the study.
* Any other circumstances that may potentially damage the minor or prevent procedures from being carried out according to evaluation of the research team.
* Child shows signs or symptoms of an active intercurrent disease (e.g. fever, rash, etc.) that may interfere with the evaluation of adverse events after immunization at the research team's discretion. In this case, the participant may be reevaluated within the following three months in order to verify eligibility.
HBOT Effect on Chronic Pain Syndrome With a History of Psychological Trauma

The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on 2 types of patients' population suffering from chronic pain syndrome (Fibromyalgia): patients with history of psychological trauma and patients with history of traumatic brain injury.

This study is a prospective clinical trial. After signing a written informed consent, all patients will be invited to medical evaluation including pain sensitivity examination and a series of questionnaires. In addition, all patients will have chest X-ray, cognitive evaluation, brain MRI and brain Single-photon emission computed tomography (SPECT)

. A second brain MRI, brain SPECT, pain sensitivity evaluation and questionnaires will be done after 3 months of treatment (60 sessions of HBOT). The HBOT procedure will be performed at the Sagol center for hyperbaric medicine and research of Assaf Harofeh Medical Center, Israel.

The following HBOT protocol will be applied for all patients: 12 weeks, 5 times per week, daily administration of 100% O2 for 90 minutes at a pressure of 2 absolute atmospheres (ATA) including 5 minutes air breaks every 30 minutes.

Patients with history of psychological trauma are also being treated with creative art psychotherapy. These patients will be randomly assigned to one of the two groups: (1) single intervention with creative art psychotherapy (psychotherapy group); (2) combined concurrent intervention of HBOT and creative art psychotherapy. Groups 1 will serve as controls during the first 3 months and then will be crossed to get HBOT. Before the cross to the HBOT they will have 2nd full evaluation (questioners and brain imaging).

Eligibility Criteria:
Inclusion Criteria:

* Females
* Age over 18
* Known fibromyalgia (chronic pain syndrome) for more than 1 year

Exclusion Criteria:

* Any past hyperbaric treatment prior to inclusion
* Patients with chest x-ray pathology incompatible with hyperbaric environment
* Patients with middle ear problems
* Patients, who cannot "pump", equals middle ear pressure, effectively
* Patients who suffer from claustrophobia
* Inability or Refusing to sign the Informed Consent Form
Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms

Almost all people who suffer from dementia experience neuropsychiatric symptoms (NPS) in the course of the disease. TIME (Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical framework of cognitive behavioral therapy (CBT). The TIME trial is designed to assess the effects of TIME on NPS in nursing homes patients with dementia and the implementation process at staff and organization level.

TIME (Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical framework of cognitive behavioral therapy (CBT).The TIME trial includes a three months cluster randomized trial in 36 nursing homes with 164 participants with dementia and a high level of agitation. Each nursing home defines a cluster and will be randomized to receive either the intervention with TIME or a brief two hours education-only intervention about dementia and NPS for the control group. TIME consists of a manual based multicomponent program which includes a rigorous assessment, the treatment, and the evaluation of neuropsychiatrc symptoms (NPS). The staff, physicians and nursing home managers receive a one-day education. Three nurses from each unit will receive further education including practical and theoretical training for three hours. Measurements at patient level are taken at baseline prior to randomization and at eight and twelve weeks. The primary outcome measure is agitation. Mixed methods will be used to follow, measure and explore the implementation process and the effect at individual staff level and at organization level.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical Dementia Rating scale (CDR) 1 or higher.
2. Moderate to high grade of agitation defined by the NPI-NH agitation item as equal to or above six points.
3. Planned long-term stay in the nursing home, and a minimum of two weeks stay in the nursing home before inclusion.

Exclusion Criteria:

1.Terminal phase (life expectancy less than 4-6 weeks)
A Novel Point-to-care Method for Fast Evaluation of Viscoelastic Hemostasis Analysis

This study compares the results of the existing coagulation monitoring technology to the Ultrasound-based viscoelastic hemostasis analysis, a new method, using small amount of extra blood obtained during routine blood draws in surgery patients.

Ultrasound-based viscoelastic hemostasis analysis is a novel POC diagnostic method, which is suitable for use in surgical care settings.

The novel viscoelastic hemostasis analysis uses ultrasound guided waves to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis, which will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.

This single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to standard coagulation tests and comparable measures using conventional viscoelastic testing methods.

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for surgery with general surgery
* Subject is 18 years or order
* Subject requires routine TEG measurement

Exclusion Criteria:

* Subject is unwilling to participate
* Subject is unable to sign a consent form
* Subject is unsuitable for blood drawing
* Subject is unsuitable for this study in the opinion of the anesthesiologist
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Adjuvant Chemotherapy in the Treatment of the Lymph Node Positive Thoracic Esophageal Squamous Cell Carcinoma

Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.

* Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.
* No standard postoperative adjuvant chemotherapy has ever been established.


Eligibility Criteria:
Inclusion Criteria:

* ability to give informed consent
* histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins
* node-positive and pathologic stage M0
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients were enrolled 4 to 10 weeks after surgery
* Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin\<2 times of upper normal institutional limits

Exclusion Criteria:

* prior chemotherapy or concurrent radiation therapy before esophagectomy
* R1 or R2 resection
* clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination
BacLite Rapid MRSA Clinical Performance

The purpose of this study is to compare the performance of the 3M(TM) BacLite (TM) Rapid MRSA test system to traditional culture methods in detecting the presence of Methicillin Resistant Staphylococcus aureus (MRSA) directly from nasal samples.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years or older
* Subjects willing to document demographic characteristics
* Subjects willing to have their nose swabbed
* Subjects (or legal representative) willing to sign consent and authorization forms

Exclusion Criteria:

* Subjects who use Vicks Sinex Nasal spray or other nasal sprays
* Subjects with prescribed nasal medical devices where collecting samples may resent more than minimal risk to subjects
* Subjects having nasal prosthetics, jewelry or trauma to the nose or anything that may prevents sampling the anterior nares
* Investigator believes that subject is unsuitable for inclusion.
Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome

Postural orthostatic tachycardia (POTS) is characterized by abnormalities in the autonomic nervous system in the body. The autonomic nervous system controls and regulates body functions such as heart rate, breathing, digestion, and more.

The investigator has shown that patients with POTS have higher cardiovascular and adrenergic activating autoantibodies (AAb), which likely changes the normal make-up of POTS. There are autoantibodies that have been suggested by a few reports of their presence in POTS, but their role different aspects of POTS is unknown. The study will look at the body's responses in patients with POTS. The crossover study design is to have half of the patients will start with sham followed by active stimulation and half will start by active followed by sham stimulation. It is anticipated that results will provide a potential therapeutic approach based on the understanding of POTS.


Eligibility Criteria:
Inclusion Criteria:

-Female or male participants age 18-80

Group 1 (20 participants):

* A physician-based diagnosis of POTS
* Participants that have a postural pulse rise of \>35 for adolescents and \>30 for adults with a Blood Pressure (BP) that does not drop \>10/5 mmHg will be qualified. These participants may be on salt and fluid loading.

Group 2 (10 participants):

* Previously diagnosed with POTS
* Patients is on Intravenous immunoglobulin (IVIG) infusion but who have an incomplete symptomatic response

Exclusion Criteria:

* Age \< 18 years
* Sick sinus syndrome, 2nd or 3rd degree Atrioventricular (AV) block, bifascicular block or prolonged 1st degree AV block (PR\>300ms).
* Currently pregnant women or women planning on becoming pregnant ≤ 6 months
* History of hypotension due to autonomic dysfunction
* Have a secondary causes of tachycardia (acute anemia or blood loss, drugs, significant cardiomyopathy, diabetes mellitus)
* Patients with active implants (such as a cardiac pacemaker, or a cochlear implant).