cyrilzakka/clinical-trials huggingface dataset:
Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation

The purpose of this research study is to evaluate the safety and feasibility of the Impella 2.5 Circulatory Support System for use during mapping and ablation of ventricular tachycardia in the setting of Ventricular dysfunction.

The Impella 2.5 is a percutaneous heart pump that will be used to provide partial circulatory support -. The Impella 2.5 is approved by the US Food and Drug Administration and is being tested to see if it helps keep the patient's blood pressure stable during the cardiac ablation procedure. The Impella 2.5 Circulatory Support System works by placing a small pump into the left pumping chamber of the heart which will then help the heart circulate blood throughout the body. The Impella 2.5 Circulatory Support system will be removed once the heart no longer needs help with the pumping action which can be at any time from just after the completion of the heart procedure up to several days post procedure as determined by physician.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* age 18 to 90 years
* catheter ablation of ventricular tachycardia
* Left Ventricular ejection fraction less than or equal to 40% or hypertrophic cardiomyopathy

Exclusion Criteria:

* Any reversible cause of VT \[electrolyte derangements, medication related itc\]
* Evidence of active, ongoing cardiac ischemia as the cause of VT
* Patients who have experienced any cerebral ischemic event including any TIA in the preceding one month
* Mural thrombus in left Ventricle
* Presence of mechanical aortic valve
* Severe Aortic Stenosis \[orifice area of 2.0 cm2 or less\] or moderate to severe aortic insufficiency
* Severe abnormalities of the aorta that would preclude Impella insertion, including aneurysms and extreme tortuosity or calcifications
* Liver dysfunction or markedly abnormal coagulation parameters \[as defined by platelet count less than or equal to 50,000/ul\]
* Any condition resulting in contraindication to anticoagulation \[eg GI bleeding\]
* Women who are known to be pregnant or have had a positive B-HCG test 7 days prior to procedure
* Patients whose life expectancy is less than one year
* Mental Impairment precluding patient or family from providing informed consent or completing the appropriate follow up
Local Anesthesia With Needle-free Injection System

The purpose of this study was to compare the pain during needle insertion and injection in mandibular molars anesthetized with either traditional syringe (control) or Comfort in System (experimental).


Eligibility Criteria:
Inclusion Criteria:

* In need of treatment of right and left molar teeth of mandible,

  * Does not have any systemic disorder,
  * High level of communication that can provide logical answers to the questions we ask
  * With parental consent,
  * Volunteers who want to participate in the research
  * 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic

Exclusion Criteria:

* No need for treatment of right and left molar teeth of mandible,
* Has a systemic condition
* Low level of communication that cannot provide reasonable answers to the questions we ask
* Without parental consent
* Do not want to participate voluntarily in the research
* Do not attend a check-in
* Patients not in the 6-12 age group
Clinical Evaluation of Four Aesthetic Restorations in Non-carious Cervical Lesions

To compare the clinical performance of high-viscosity glass ionomer, flowable composite, bulkfill composite and nanohybrid composite restorations in non-carious cervical lesions (NCCLs).

One hundred fourty NCCLs were randomised into four groups according to a split-mouth design. Clinical evaluations will be performed after 1 week, 3 months, 6 months, using FDI (World Dental Federation) criteria.

Eligibility Criteria:
Inclusion Criteria:

* had at least four non-carious symmetrical cervical lesions,
* had permanent dentition and were older than 20 years old,
* had cervical margins in dentin

Exclusion Criteria:

* periodontal disease
* pregnant or breastfeeding
* being under orthodontic therapy
Freeze-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients

Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is present in 40% of cases. It has a very early onset and this coagulopathy is associated with increased mortality. It must be detected and treated early, as illustrated by the military medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP) requires a thawing step.The French army has encouraged the development of a freeze-dried plasma of innovative because viral inactivation and universal blood grouping, well tolerated, with a reduced risk of TRALI. This sophisticated therapeutic product can be administered after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used is currently reserved for military purpose in overseas operations and needs to be evaluated for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of an immediate availability of plasma.


Eligibility Criteria:
Inclusion Criteria:

* Emergency
* Trauma patient admitted in participating trauma care centers
* Severe bleeding requiring transfusion with 4 units of red blood cells and 4 emergency plasma.
* Inclusion performed within the first 6 hours after trauma.

Exclusion Criteria:

* Patient taking anticoagulants
* Patients who have received hemostatic treatment during transport (tranexamic -acid excluded)
* Minor Patient
* Pregnant or breastfeeding women
The Reliability of ULRT in Overhead Athletes and Its Relationship With Selected UEPT

Upper Extremity Rotation Test is a new test the evaluates 90-90 position, which is one of the requirements for overhead throwing. The aim of the study was to evaluate the reliability of the Upper Extremity Rotation Test in overhead athletes and the relationship between the Closed Chain Upper Extremity Stability Test and the Upper Quarter Y Balance Test.

Upper Extremity Rotation Test is a new test the evaluates 90-90 position, which is one of the requirements for overhead throwing. The aim of the study was to evaluate the reliability of the Upper Extremity Rotation Test in overhead athletes and the relationship between the Closed Kinetic Chain Upper Extremity Stability Test and the Upper Quarter Y Balance Test. Upper Extremity Rotation Test was found to be reliable in overhead athletes. Upper Extremity Rotation Test showed high reliability in overhead atheletes. There was no correlation between the Upper Exremity Rotation Test and the Upper Quarter Y Balance Test. A moderate corelation was found between the Upper Extremity Rotation Test and Closed Kinetic Chain Upper Extremity Stability Test.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 years
* Continuing sports for at least three years for each group (volleyball, handball, baskeball)
* Athletes training at least three days per week.

Exclusion Criteria:

* Individuals experiencing difficulty understanding what the physiotherapist says.
* Having a history of orthopedic surgery within the last year
Oral Estramustine and Oral Vinorelbine in the Treatment of Hormone-Refractory Prostate Cancer

Purpose: This clinical trail will combine the chemotherapy drugs, Estramustine and Vinorelbine (Navelbine), on an intermittent therapy strategy based on PSA response in the treatment of hormone refractory prostate cancer. The investigators will determine the tolerable dose of (oral) vinorelbine in combination with (oral) estramustine, and evaluate the efficacy of this treatment for patients with hormone-refractory prostate cancer.

Hormone Refractory prostate cancer refers to advanced disease in which a patient no longer responds to conventional hormonal treatment. When hormone therapy is no longer successful, chemotherapy is a treatment option. However, current single-agent treatment has shown to have limited benefit. In this clinical trial, investigators are evaluating the effectiveness of combining two chemotherapy drugs, Estramustine and Vinorelbine (Navelbine), in the treatment of hormone refractory prostate cancer. Estramustine has been used in the treatment of prostate cancer for many years. Vinorelbine has shown activity in prostate cancer. In addition, the effect of this treatment on the quality of life of patients will be evaluated as measured using the FACT-P.

Eligibility Criteria:
Inclusion:

* Patients must have a histologic diagnosis of adenocarcinoma of the prostate. (No evidence of brain metastasis or untreated spinal cord compression.)
* Patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate at rising PSA (Prostate Specific Antigen) 4 weeks after withdrawal for flutamide and 6 weeks after withdrawal for bicalutamide or nilutamide.
* Patients must have measurable soft tissue disease or evaluable (abnormal bone scan and/or elevated PSA). If PSA is the only evidence of progressive disease it must be greater than or equal to 4ng/mL.
* Adequate bone marrow, renal and liver function
* ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (a measure of general well being on a scale of 0-5 where 0 represents asymptomatic and 5 represents death)
* Must be at least 18 years of age
* Must have a life expectancy of greater than or equal to 12 weeks

Exclusion:

* Have previously received vinca alkaloid-based cytotoxic chemotherapy or radiation to greater than or equal to 50% of the total bone marrow.
* Evidence of brain metastasis
* Spinal cord compression
* Prior malignancy except for in situ carcinoma, nonmelanoma skin cancer, or adequately treated malignancy that has been inactive for less than 3 years
* Patients with preexisting neuropathy of greater than or equal to grade 2
* Active gastrointestinal disease, or a disorder that alters gastrointestinal motility or absorption
The Effect of Dairy Fat and Inulin on Fasting Induced Adipose Factor (FIAF) Blood Concentrations

The objective of this study is to investigate whether intake of a diet with a high content of butyrate (from dairy fat) can affect blood FIAF concentration compared to a control diet. Further to examine whether high intake of inulin (a prebiotic) can increase the proportion of butyrate-producing bacteria in the gut and thereby affect blood FIAF concentration. In addition, the correlation between FIAF blood concentrations and resting energy expenditure, blood lipid profile and gut microbiota composition will be investigated.

Furthermore, this study will investigate whether the source of FIAF can be determined. To this end, adipose tissue biopsies will be analyzed and an in vitro experiment with fecal water samples will be carried out.

The study is a crossover randomized controlled trials with 3 arms. Each arm has a duration of 3 weeks. 20 overweight/obese subjects will be enrolled into the study and randomized to the order of interventions. Before and after each intervention period, blood samples will be collected and the participants will have their resting metabolic rate measured. At the end of each intervention period, the participants will collect feces for 5 consecutive days. In addition, adipose tissue biopsies will be taken after each intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Age: 23-45
* BMI: 25-32 kg/m2
* Body fat percentage (BFP) \> 25

Exclusion Criteria:

* Chronic diseases (known diabetes, cardiovascular disease (CVD), Intestinal Bowel Disease and other chronic diseases likely to affect the results of the present study)
* Milk allergy/lactose intolerance
* Intolerance towards inulin
* Fasting glucose ≥7.0 mmol/l or non-fasting glucose ≥ 11 mmol/l\*
* Use of antibiotics 2 months before commencement of study
* Use of dietary supplements incl. multivitamins during run-in and the entire study period
* Smoking
* Elite athletes (\>10 hours of strenuous physical activity per week)
* Use of prescription medicine which could affect the results of the present study, including systemic glucocorticoids
* Use of lipid-lowering agents or medication with contraindications for a high fat diet
* Blood pressure \> 140/90 mmHg
* Blood donation \<1 month before study commencement and during study period
* Simultaneous participation in other clinical studies
* Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
Feasibility Study of Preimplantation Genetic Diagnosis for Single-gene Disorders

Preimplantation Genetic Diagnosis (PGD) for monogenic diseases is usually performed by multiplex PCR combining polymorphic microsatellites familial analysis and, where possible, couple-specific mutation detection. Single-cell multiplex PCR developments are costly and time-consuming. We propose to test and clinically validate a targeted next-generation sequencing approach for the PGD for cystic fibrosis. This technique would allow a PGD for probably almost every couple asking for it in our centre, without a previous couple-specific development (but only a preliminary familial analysis). It will be based on haplotyping using a large number of SNPs and mutation detection. A clinical validation will be performed by reanalysing non-transferable embryos obtained after PGD for cystic fibrosis, with couple's informed consent. Concordance of the results between PGD and reanalysis by NGS will be achieved and if validated, this technique may be applied to future PGD for cystic fibrosis in our centre. The same technique may then be applied for other PGD indications for which a set-up is often needed.


Eligibility Criteria:
Inclusion Criteria:

* Age\> or = 18 years
* Couples at risk of transmitting cystic fibrosis
* asking for a PGD in Strasbourg
* DNA samples available at the laboratory for:

  * The couple
  * A related with CFTR status known
  * Having signed an informed consent

Exclusion Criteria:

* Inability to give informed consent (understanding difficulties...)
Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

This study is a multicenter, open, and randomized clinical phase II exploratory study. The "pick the winner" study design is used to determine and select which chemotherapy drug (irinotecan vs. albumin plus paclitaxel) is more effective in the second-line treatment of advanced gastric cancer, and it is more hopeful to carry out the follow-up phase III study in the second-line treatment of advanced gastric cancer (karelizumab+chemotherapy vs. chemotherapy). The study plans to include 184 patients with advanced gastric cancer who have received first-line platinum+fluorouracil progression, randomly use albumin paclitaxel+carrelizumab or irinotecan+carrelizumab second-line therapy, and observe the objective effective rate (ORR), total survival time (OS), progression free survival time (PFS), treatment related adverse reactions, quality of life and other clinical indicators after receiving the above treatment, Then determine the second line scheme which is more advantageous.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-75
* ECOG score: 0 or 1
* Unresectable advanced or recurrent gastric cancer/gastroesophageal junction cancer
* histologically proven adenocarcinoma
* Received chemotherapy based on platinum and fluorouracil within 12 months
* Patients not previously treated with paclitaxel or irinotecan
* Liver function: total bilirubin, ALT and AST\<1.5 × ULN (Normal Value upper limit)
* Renal function: Cr\<1.5 × ULN and creatinine clearance ≥ 40 ml/min
* Echocardiography or radionuclide cardiac function test, LVEF ≥ 50%
* Expected survival ≥ 3 months
* Sign the informed consent form

Exclusion Criteria:

* Patients who have received irinotecan or paclitaxel chemotherapy in the past
* ECOG PS score:\>2
* Advanced gastric cancer patients with extensive and severe peritoneal metastasis
* Patients with severe liver and kidney insufficiency or cardiac insufficiency
* HIV positive, active hepatitis B or C, active pulmonary tuberculosis
* Patients with active autoimmune diseases, including lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, etc
* Patients known to be allergic to any of the study drugs
* Pregnant or lactating female patients
Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants with Permanent Ileostomy

To date, patients with Crohn's Disease (CD) and permanent ileostomies have been excluded from clinical trials for new treatments. To allow this patient population to be included in clinical trials, outcome and measurement tools are needed. This study aims to develop a Patient Reported Outcome (PRO) and Endoscopic Index (EI) for patients with Crohn's Disease (CD) and permanent ileostomy. The study will enroll about 50 participants and collect videos of endoscopies that are done as part of standard of care. The videos will be centrally read to identify features that represent a broad range of inflammation and will be used to develop the EI. Participants will also be asked to participate in interviews, to understand the symptoms and impacts that are most important to participants for the development of a PRO.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (age ≥ 18 years) with a diagnosis of CD treated surgically with subtotal colectomy/proctocolectomy end ileostomy at least 12 months prior to the scheduled endoscopy procedure.
2. Planning to have an ileoscopy procedure scheduled as part of routine medical care.
3. Be proficient in the English language (ie, ability to read, write, speak, and understand English well enough to take part in the interview process without the aid of an interpreter).
4. Able and willing to participate fully in all aspects of this study.
5. Written informed consent must be obtained and documented.

Exclusion Criteria:

1. End or loop colostomy, end ileostomy for UC, continent ileostomy, ileal pouch anal anastomosis, end ileostomy with mucous fistula, double barrel ileostomy, urostomy, loop ostomy, or any type of end ileostomy not considered permanent at the time of enrolment (with no intent to restore continuity).
2. Peristomal skin complications such as pyoderma gangrenosum, abscess, or any other severe peristomal skin inflammation.
3. Stomal stenosis obviating ileoscopy, known small bowel stricture, major stoma prolapse, symptomatic parastomal hernia, parastomal hernia with subcutaneous loops of small bowel within the hernia, stoma in a crease/poorly fitting applicable resulting in severe peristomal skin irritation, or retracted stoma that prevents endoscopic evaluation.
4. Any actively draining fistula (eg, peristomal or peri-anal).
5. Evidence of a known small bowel stricture on cross-sectional imaging or inability to pass an endoscope within the past 6 months.
6. Known active Clostridoides difficile or other enteric infection.
7. Short bowel syndrome.
8. Predominant symptom(s) arising from a retained rectal stump.
9. Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study procedures or provide nonconfounded descriptions of their CD and ostomy symptom experiences during the interview.
10. Prior enrolment in the current study.
Drug Interaction Study Between AZD3480 and Cytochrome P450

The purpose of the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 activity.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written informed consent
* Clinically normal physical findings and laboratory values

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma within three weeks before the first dose
* History of clinically significant disease
* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Digital Self-Management and Peer Mentoring Intervention

This study tests how helpful a digital self-management and peer mentoring program is to young adult survivors of childhood cancer to improve their ability to manage their survivorship care as they transition from pediatric to adult-oriented follow-up care. Survivors require lifelong "risk-based" follow-up care based on the treatment they received to identify and treat late health effects. The transition from pediatric to adult follow-up care is a critical period when many survivors are lost to follow-up. Barriers to successful transition and engagement in care include poor knowledge of cancer history, low healthcare self-efficacy, poor self-management skills, low health literacy, and access issues such as financial hardship, insurance, and distance from cancer center. The "Managing Your Health" digital self-management and peer mentoring program aims to address these gaps and improve survivorship care self-management. Improvements in healthcare self-management are necessary to keep young adult survivors engaged in recommended health care, improve their quality of life, and promote optimal health.

The purpose of the study is to determine the efficacy of the Managing Your Health intervention to improve self-management of survivorship care among young adult survivors of childhood cancer.

Aim 1: Evaluate the efficacy of the Managing Your Health intervention. Aim 2: Determine the mechanisms through which Managing Your Health influences outcomes.

Aim 3: Identify subgroups of participants for which treatment effects vary to inform future scale up.

Managing Your Health will be tested in a two-arm parallel randomized controlled trial (RCT) of the intervention versus usual care + educational control with 300 young adult survivors of childhood cancer currently aged 18-25 years. Participants will complete outcome measures at baseline, 3 months, and 12 months post-randomization.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis with any malignant childhood cancer between the ages 0-19 at least 5 years prior
2. Cancer treatment occurred at a pediatric center/facility
3. Current age 18-25
4. At least 2 years from treatment completion (typical time for transfer to long-term follow-up care)

Exclusion Criteria:

1. Any documented physical or self-reported cognitive delay that could prevent self-management of health care
2. Diagnoses of cancer not typically considered pediatric (I.e., melanoma, carcinoma of the breast, colorectum, lung, ovary, and testicle)
3. Unable to speak/read English