cyrilzakka/clinical-trials huggingface dataset:
Predictive Role of Microbiome in Patients With Urothelial Carcinoma

This study aims to establish the microbiota composition as a predictive tool for the response to the intravesical immunotherapy with Bacillus Calmette-Guérin (BCG) and 2 different chemotherapies schemes.

In this prospective cohort study patients with low/intermediate/high risk non muscle invasive bladder carcinoma (NMIBC) that undergo BCG/chemo treatment will be enrolled to collect urine stool and blood at different endpoints. Microbiota, short-chain fatty acids and immunophenotype will be quantified to develop a predictive screening platform, which might also integrate traditional urinary cytology and FISH data.

The purpose of this research is to understand the possible use of microbial profile from catheterized urine and feces of patients with NMIBC to categorize patients in two groups: those likely to respond positively and those unlikely to respond to the therapy. Goal of this study is to identify the predictive role of the microbiome to therapy response, thus allowing clinicians to deliver the most appropriate treatment based on the microbiome (microbiome-personalized therapy).

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 18 years, all able to signed informed consent form;
* Diagnosis of NMIBC provided by an experience pathology, by using tissue specimens that were staged according to the TNM classification and morphoarchitectural criteria according to the WHO classification.

Exclusion Criteria:

* Participants with ongoing urinary tract infection;
* Antibiotic treatment within the last month;
* Immuno-/chemo- therapy within the past 3 months;
* Chronic immunosuppressive therapy;
* Additional major diagnosis known to affect the gut or bladder microbiota;
* Use of probiotics;
* Uncontrolled diabetes;
* Participants with other malignancy or previous history of oncological or autoimmune diseases.
Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage

The purpose of this study is to test whether treatment with a drug called Simvastatin prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is currently approved for the treatment of high cholesterol levels.

Aneurysmal Subarachnoid hemorrhage or SAH (bleeding on the surface of the brain) affects 10 per 100,000 population each year. For survivors of the initial hemorrhage, delayed narrowing of the blood vessels (vasospasm) and related delayed strokes are the most common serious complication. Narrowing of blood vessels affect 30% of patients with such bleeding. Despite maximum therapy, nearly 50% of patients with symptomatic vasospasm with develop stroke. Because cerebral vasospasm remains the leading cause of morbidity and mortality after aSAH, this critically important issue needs further studies.

One hundred and fifty patients will be randomized, 50 to each arm of the study. Patients enrolled in the study will be receive the drug (either Simvastatin 40 mg or Simvastatin 80 mg per mouth daily), while the control group will receive a sugar tablet. The treatment will be continued for a total of 21 days. The neurological abilities (Stroke Outcome measures, these are included with the application for your review) at day 21 post aSAH will be reviewed at time of discharge as well at 6 months of follow up.

Eligibility Criteria:
Inclusion Criteria:

* 18-85 years old inclusive
* Subarachnoid hemorrhage diagnosed by CT on admission
* Randomizable within 732 hours of subarachnoid hemorrhage
* Saccular intracranial aneurysm proven by cerebral angiography or computed tomographic angiography (CTA)
* Surgical or endovascular obliteration
* Able to obtain written informed consent from patient or surrogate

Exclusion Criteria:

* Pregnancy, as confirmed by routine urine test on admission
* Elevated liver function test at time of randomization, defined as more than three times the upper limit of normal
* On Statins, niacin, or fibrate therapy within 30 days of presentation
* Any vasospasm on the initial diagnostic angiogram
* Glasgow Coma Scale 5 or less at the time of randomization
* History of liver disease or active liver disease
* Hypersensitivity to statins
* Patient taking medication not recommended for concomitant use with Simvastatin (40 or 80 mg) as per the product label
Therapeutic Recommendations for Nephroblastoma

The study is based on results form 2 previous studies carried out by the GFAOP. The aim of this study is to evaluate the capacity of units to follow the recommendations in the protocol.

The study is based on results form 2 previous studies carried out by the GFAOP. This study aims to evaluate the capacity of units to follow the recommendations in the protocol. It will look mainly at treatment compliance and outcome for the children treated. The study will also evaluate the improvement in treatment compliance and reporting. This work will help the group to evaluate future needs in participating units and help us adapt treatment programmes to local conditions.

Eligibility Criteria:
Inclusion Criteria:

Unilateral Nephroblastoma Tumor Not previously treated The general health of the child will permit treatment.

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Exclusion Criteria:

Bilateral Nephroblastoma tumor Previously treated Disease too advanced Doubt concerning the diagnosis Treatment Refusal
Registry of Asthma Characterization and Recruitment 3 (RACR3)

This is a multi-center, non-interventional registry to create and maintain a database of participants to serve as a recruitment source for current and future DAIT NIAID-sponsored Childhood Asthma in Urban Settings (CAUSE) studies.

Protocol CAUSE-02 RACR3 is a multi-center, non-interventional registry to create and maintain a database of participants to serve as a recruitment source for current and future DAIT NIAID-sponsored Childhood Asthma in Urban Settings (CAUSE) studies. Approximately 1,500 participants - of all ages, living in selected Office of Management and Budget (OMB) defined Metropolitan Statistical Areas (MSAs) will be enrolled in the registry.

The registry database will be generated with data gathered at a single core visit, followed by optional additional visits. The registry will include assessments of various asthma and allergy characteristics to achieve a more flexible, efficient, selective, and inclusive approach to participant recruitment while still following national guidelines to foster participant safety. CAUSE investigators may invite children or adults without asthma or atopic diseases to participate in the registry as "healthy" controls; for validation of laboratory tests, study monitoring equipment, and/or procedures; or for site procedure training of study personnel for certification and quality assurance.

Participants may opt to withdraw their information or discontinue from the registry at any time, in person, by telephone, or in writing.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is either:

   1. At least 18 years old, willing and able to provide informed consent at the time of enrollment
   2. Under the age of 18, accompanied by a legal guardian who is willing and able to provide informed consent at the time of enrollment
2. Participant has a primary place of residence within the Office of Management and Budget (OMB)-defined Metropolitan Statistical Area (MSA)

Exclusion Criteria:

1. Participant does not speak English or Spanish and/or guardian does not speak English or Spanish
2. Participant does not have access to a phone, either personal or public, with regularity that could be used for scheduling and safety follow-up
3. Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may affect the quality or interpretation of the data obtained from the study

Participants who are pregnant or lactating will not be excluded or discontinued from the study, but will not undergo any procedures that are prohibited during pregnancy per the Childhood Asthma in Urban Settings 02 (CAUSE-02) Registry for Asthma Characterization and Recruitment 3 (RACR3) Manual of Procedures (MOP)(e.g., allergen skin testing, spirometry) during the pregnancy.

Potential participants may be reassessed as outlined in the Protocol CAUSE-02 MOP.
Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial

The purpose of this study is to compare postoperative complications between hand sewn and stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid obesity.


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years
* absence of previous bariatric surgery

Exclusion Criteria:

* less than 18 years old
* coagulation disorders or liver cirrhosis
Capnography in Infants Ventilated With High Frequency Ventilation

The investigators hypothesize that dEtCO2 measured by the Microstream® technique via a double-lumen ETT in infants ventilated with HFV would be feasible and adequately represent the arterial CO2 (PaCO2).

All infants with double lumen ETT on HFV are eligible.

Eligibility Criteria:
Inclusion Criteria:

* All intubated infants with double lumen ETT ventilated with HFV

Exclusion Criteria:

* Infants ventilated with single lumen ETT
Postoperative Analgesia With Erector Spinae Plane Block After Pectus Excavatum Repair in Children

The purpose of this study is to evaluate the efficacy of erector spinae plane (ESP) block in children after pectus excavatum repair (nuss procedure).


Eligibility Criteria:
Inclusion Criteria:

* 30 children aged between 3 and 7 years who undergo Nuss bar insertion due to Pectus excavatum

Exclusion Criteria:

* Allergy to opioid
* Allergy to local anesthetics
* Disease in heart, lung, kidney, and liver
* Coagulation disorder
* Disease in central and peripheral nervous system
Assessing the Technique of Ovarian Tissue Cryopreservation by Vitrification in Vietnam

Ovarian tissue cryopreservation (OTC) is a new approach on fertility preservation for young female patients with cancer. It is now used by many IVF centers in the world. However, this is the first study which OTC by vitrification is carried on and assessed the effectiveness of the technique.

Ovaries from all less than 45 year-old breast cancer patients who undergo oophorectomy by laparoscopy after treated with chemotherapy will be enrolled to the study. Pieces of cortex of each patient will divide into two groups. Group 1 is fresh fragments (control group) and group 2 is vitrified group. Ovarian tissues in group 2 will be vitrified or warmed with medium and devices of Ova-kit type M (Kitazato, Japan).

Cortex fragments of each group will have:

* Follicle survival evaluation by Neutral red staining
* Histological evaluation by Hematoxylin and Eosin staining
* Evaluation relative Growth Differentiation Factor 9 (GDF-9) and Caspase-3 gene expression by real-time Polymerase chain reaction (PCR).

Comparison of data collected from 2 groups will be carried on to evaluate the effectiveness of the technique before applying this technique for cancer patients in Vietnam.

Eligibility Criteria:
Inclusion Criteria:

* Ovaries from all less than 45 year-old breast cancer patients who undergo oophorectomy by laparoscopy after treated with chemotherapy

Exclusion Criteria:

* The volume of ovaries is less than 2/3 of normal 3cm (L) x 2.5cm (H) x 1.5cm (W) ovary.
The Effect of Repeated Lifestyle Intervention on Weight Loss Maintenance

In Denmark and the western world, there is an increasing prevalence of obesity probably due to a combination of inadequate daily physical activity and a high energy intake. One approach to achieve weight loss and change life style is to participate in an intensive supervised prolonged life style modification course. The immediate effect is often positive, but over time the overall effect is limited as the majority will not maintain weight loss and a changed life style.

In this study we will analyse the results of the intensive lifestyle intervention as it has been practised at Ubberup Folk High School over the last 13 years. As some people have several stays at Ubberup Folk High School we want to we have a special interest in the effect of repeated lifestyle intervention.

Research question:

What is the effect of several lifestyle interventions on weight loss maintenance?

The study design is retrospective and descriptive and will be based on a lifestyle intervention, as it has practiced in a real life setting at Ubberup folk high school.


Eligibility Criteria:
Inclusion Criteria:

* Former participants of the intensive lifestyle intervention at Ubberup Folk High School.

Exclusion Criteria:

* Gastric bypass surgery or banding
Effectiveness of Reanimator Muller in Patients With Chest Tube

This study evaluates the comparison of two of re-expansion pulmonary physiotherapy in patients with chest tube. The study group received intermittent positive pressure intervention and the control group received incentive spirometry intervention associated with manual operation.

All the re-expansion methods increase lung volume increasing gradient of transpulmonary pressure (PL) representing the difference alveolar pressure and pleural pressure. Spontaneous deep breath increases the PL by reducing pleural pressure (active breathing exercises, breathing supporters and manual operation).

Muller resuscitator consists of a pneumatic valve feature designed to operate with medical oxygen. It is used intermittently or continuously for pulmonary re-expansion, with lower load imposed work, and increase the efficiency of gas exchange by improving volumes, lung capacity and breathing pattern, and reverse atelectasis.

However, studies show the paucity of data in the literature regarding the Muller Resuscitator in different forms and respiratory rehabilitation protocols. In addition, studies show lack of standardization of methods and resources used in respiratory therapy in patients with chest tube.

Eligibility Criteria:
Inclusion Criteria:

* Patients with old more 18 years untill 65 years
* Patients undergoing thoracic drainage
* That does not include in any exclusion criteria

Exclusion Criteria:

* Contraindications breathing equipment use positive pressure

  * Patient intolerance
  * Phobia
  * Hemodynamic instability
  * Use of vasopressiva therapy
  * Shock (systolic pressure \<90 mmHg)
  * Face trauma
  * Nausea or vomiting
  * Acute myocardial infarction
  * Lobectomy
  * Lung cancer
  * Gastrointestinal surgery
  * Pleural fistula.
Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.

This study was closed to enrollment on 18 April 2011 due to inability to recruit patients on a timely basis as well as business reasons. Study closure was not related to any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age with advanced solid tumors for which the combination of figitumumab and pegvisomant are reasonable treatment options.
* Patients between the ages of 10 and 18 years with advanced sarcomas for which there is no available curative therapy or therapy proven to prolong survival with an acceptable quality of life will be included in the Sarcoma Expansion Cohort.
* Adequate recovery from prior therapies.
* Adequate organ function (i.e. bone marrow, kidney, liver)
* Total IGF-1 ≥100 ng/ml (13 nmol/L).

Exclusion Criteria:

* Concurrent treatment with any anti-tumor agents.
* Pregnant or breastfeeding females.
* Significant past history or active cardiac disease
* Active infection
* History of diabetes mellitus.
* Glycosylated hemoglobin \>5.7
The Effect of Dietary Nitrate Supplementation on Linear Running Sprint Performance, Agility and Vertical Jump Performance in a Rested and Fatigued State

Dietary nitrate (NO3-) supplementation has been shown to improve skeletal muscle contractility and fatigue resistance, particularly in fast-twitch (type II) muscle fibers. Furthermore, NO3- supplementation has been shown to speed reaction time. Taken together, these findings suggest that NO3- ingestion may be ergogenic during all-out sprint running and reactive agility tasks. Moreover, increasing muscle force production at high contraction speeds would be expected to translate into improved muscle power and, subsequently, improved performance in very explosive forms of exercise, such as vertical jumping. Therefore, the purpose of this investigation is to assess the effect of short term (5 days) NO3- supplementation on linear running sprint performance, reactive agility and vertical jump performance in a rested and fatigued state.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants in self-reported good general health as assessed by the standard procedures described below and specifically meeting normal blood pressure range (systolic: 100-135, diastolic: 60-90) and body mass index (BMI) range (16.0-29.9)
2. Range of 18-45 years of age
3. Participants must participate in an intermittent exercise based sport (e.g. soccer, rugby, hockey), at a competitive level (i.e. competes in officiated matches/games).
4. Understanding of the procedures to be undertaken as part of the study
5. Willingness to participate in exercise testing and follow supplementation guidelines and other instructions provided by the experimenter
6. Informed, voluntary, written consent to participate in the study

Exclusion Criteria:

1. Known pulmonary, cardiovascular or metabolic disease
2. Food allergies including phenylketonurea (PKU)
3. Current regular use of any dietary supplement (excluding macronutrient based supplements) or previous use of any dietary supplement in the past 6 months that is known to have a lasting effect.
4. Blood donation within 3 months prior to the start of the study
5. Substance abuse within 2 years of the start of the study
6. Smoking
7. Any prescription and non-prescription medication which may impact saliva production (antidepressants, diuretics, analgesics, antihistamines, anti-hyper/hypo-tensives, anti-anxiety, appetite suppressants).
8. Current or previous use of phosphodiesterase 5 (PDE5) inhibitors.
9. Participation in another clinical trial within past 4 weeks.
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18 to 70 years.
* Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).
* Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.

Exclusion Criteria:

* Evidence of a medical condition associate with chronic liver disease other than HCV.
* History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.
* History of hemophilia.
* History of torsade de pointes.
* Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
* History of gastrointestinal disease or surgical procedure (except cholecystectomy).
* History of clinically significant cardiac disease.
* Blood transfusion within 4 weeks prior to study drug administration.
* Poor venous access.
* Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.
The Effect of Turkish Coffee on Postural Control and Hand-eye Coordination in Young Adults

Although the effects of different doses of caffeine on balance have been evaluated in various studies, the effects of low doses of caffeine ingested with Turkish coffee on postural control and hand-eye coordination remain unclear. In this study, it will be investigated the acute effects of 60 mg caffeine intake via Turkish coffee on postural control and hand-eye coordination.

This study is designed as a one-group pretest-posttest quasi-experimental research. The study will be conducted with healthy young adults with low coffee consumption habits. Participants who meet the inclusion and exclusion criteria will undergo postural control assessment with the Biodex Balance System® and hand-eye coordination test with the Alternate Hand Wall Toss Test. Subjects will be given 65 ml of Turkish coffee (one cup) to ensure oral caffeine intake. The same assessments will be repeated 30 minutes after caffeine intake.

Eligibility Criteria:
Inclusion Criteria:

* Being 18-26 years of age
* Having a normal body mass index

Exclusion Criteria:

* Having a health problem that prevented caffeine intake
* Having a diagnosis of vestibular and neurological disease
* Using drugs that affect the central nervous system
* Using any medication related to chronic disease
* Having lower extremity rotational alignment disorder
* Having a history of lower and/or upper extremity injury or surgery in the last year