cyrilzakka/clinical-trials huggingface dataset:
Fecal MicrobiotaTransplant for the Treatment of Parkinson's Disease

FMT may significantly improve quality of life and Parkinson Disease (PD) symptom severity measurements. We hypothesize that gut microbial dysbiosis is a major contributing factor in Parkinson's disease.

This is an open-label clinical trial to evaluate the Safety of fecal microbiota transplant following a 10 day treatment with Vancomycin in adult subjects with Parkinson's disease. Subjects in the study are required to meet with the study clinician on 11 occasions: two (2) visits for informed consent and baseline assessment, one (1) visit prior to FMT for colonoscopy instructions and exam, one (1) visit for the fecal microbiota transplant procedure by colonoscopy at an outpatient surgical center, seven (7) visits for post-FMT assessment. There are also daily phone calls in the week following the FMT, and weekly phone call visits (during weeks in which there is not a physical visit) to check up on how the subject is doing, any change in medications, side effects, and answer any questions.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with PD

Exclusion Criteria:

* Non-PD individuals
IV Contrast-Enhanced Cone Beam Computed Tomography (CBCT) in Radiotherapy

The purpose of this study is to find out if giving intravenous (IV) contrast (a liquid that helps with the visibility of organs and blood vessels that is given through the vein with the use of a hollow needle) during a Cone Beam Computed Tomography (CBCT- a type of computerized X-ray) can help people who have image guided radiation therapy (IGRT) for the treatment of abdominal and pelvic tumors.

The goal of this pilot study is to determine the feasibility and utility of administering IV contrast during a Cone Beam Computed Tomography (CBCT) in subjects who have image guided radiation therapy (IGRT) for the treatment of abdominal and pelvic tumors. Participant duration is one visit.

Subjects will be required to fast for at least 2 hours prior to study procedures, as determined by the treating physician based on the site to be irradiated. An 18- to 22-gauge peripheral IV will be placed in the subject's arm prior to being brought to clinical treatment room. The patient will be placed in position for radiotherapy as per standard of care and will be connected to IV contrast injector. Standard of care IGRT techniques will be performed to confirm correct positioning. Iodinated IV contrast will be administered and the contrast enhance cone beam CT will be initiated. Treatment will then be administered with the patient in the position determined by non-contrast cone beam CT, as per standard of care. Immediately after completion of treatment of the subject, the study physician will complete physician survey of attitude about the utility of contrast-enhanced cone beam CT.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be greater than or equal to 18 years of age.
2. Subject must be able and willing to sign a written informed consent document.
3. Subject requiring image-guided external beam radiotherapy to abdominal or pelvic tumor with cone beam CT deemed clinically necessary by the treating physician.
4. No history of prior allergic reaction to intravenous CT contrast medium.
5. Creatinine of less than 1.9 mg/dL measured within one month prior to enrollment on the study.
6. No administration of intravenous contrast within 24 hours of administration of intravenous contrast on protocol.
7. Ability to complete New York Presbyterian Hospital iodinated contrast media administration questionnaire.
8. Negative pregnancy test for females of childbearing potential, in accordance to institutional guidelines.
9. Ability to fast for at least 2 hours prior to study procedures.
10. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3.

Exclusion Criteria:

1. Known allergy to iohexol or any iodinated intravenous contrast medium.
2. Fluid overload that would contraindicate bolus administration of intravenous contrast.
3. Pregnant or nursing subjects.
4. Presence of single kidney or transplanted kidney
5. Acute renal failure
6. Chronic renal insufficiency, stage IV or V.
7. Administration of iodinated intravenous CT contrast medium within 24 hours of study procedures.
8. Inability to fast for at least 2 hours prior to study procedures.
Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma

The purpose of this study is to determine whether bevacizumab and nimustine are effective in the treatment of recurrent high grade glioma and to explore whether there is any subgroup being sensitive to this therapeutic protocol.

Although anti-angiogenesis therapy for glioblastoma(GBM) are showing promise, GBMs often develop resistance to treatment within months or weeks after salvage therapy. There are still no effective markers to predict the response rate to bevacizumab.

So the investigators initiate a single-arm Phase II study to evaluate the efficacy and tolerability of bevacizumab and nimustine regimen and to explore the predictive markers in patients with recurrent high-grade glioma.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of primary tumor as high-grade gliomas (WHO III or IV)
* All patients should complete radiotherapy and chemotherapy for primary gliomas
* Enhanced MRI and magnetic resonance spectroscopy showed unequivocal evidence of tumor recurrence or progression.
* Those patients underwent surgical resection after tumor recurrence can also be enrolled if histological diagnosis of GBM is available, and MRI within 3 days after operation is needed.
* The patients with recurrent gliomas didn't undergo bevacizumab therapy before enrollment.
* The time to be enrolled should be more than 90 days after the radiation therapy, more than 28 days after operation for recurrent tumor or prior chemotherapy.
* Eastern Cooperative Oncology Group score: 0-2
* Written informed consent
* Laboratory test: Neutrophil count \> 1.5\*10\^9/L, platelet count \> 100\*109/L, hemoglobin \> 8 g/dL, blood urea nitrogen and creatinine \< 1.5 upper limit of normal(ULN), blood total bilirubin and conjugated bilirubin \< 1.5 ULN, alanine aminotransferase(ALT) and aspartate aminotransferase(AST) \< 3 ULN, alkaline phosphatase(AKP) \< 2 ULN

Exclusion Criteria:

* Pregnant or lactating women
* Allergic to administered drugs
* Radiation therapy in the previous 90 days before enrollment
* The patients with recurrent gliomas were treated with bevacizumab therapy before enrollment.
* Acute infection in need of antibiotics intravenously
* Participation in other clinical trials in the 90 days before enrollment
Delayed Cord Clamping and Use of Oxytocin

The purpose of this study is to determine if oxytocin administration immediately after delivery of the infant modifies the volume of placental transfusion in healthy term infants.

Randomized controlled trial with 2 arms to test the influence of oxytocin in placental transfusion.

Placental transfusion: the amount of blood that passes to the baby from the time of birth until the cord is clamped.

The difference in weight between a measurement at birth and a second one after clamping the cord at 3 minutes will be considered as proxy for placental transfusion.

In one arm the oxytocin will be used immediately after birth and the cord clamped at 3 minutes In the other arm the oxytocin will be administered at 3 minutes of birth after the cord is clamped.

Eligibility Criteria:
Inclusion Criteria:

* Healthy single Term pregnancies.
* Vaginal delivery.
* Informed consent obtained.
* Presence of an investigator

Exclusion Criteria:

* Placenta previa.
* Previous history of Postpartum hemorrhage
* Intrauterine growth restriction .
* Major congenital malformations.
* Eclampsia
* Extraction of blood sample for bank of umbilical cord stem cells.

Elimination criteria:

* Need for immediate assistance of the newborn
* Birth weight less than 2500 g
* Nuchal cord wrapped too tight
* Surgically finished delivery
* Short umbilical cord which might prevent placing the infant on the scale
* Technical difficulties to obtain the weight
PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability

PERC rule was created to rule out pulmonary embolism (PE) without further exams, with residual PE risk \<2%. Its safety is currently confirmed in low PE prevalence populations as north-American. In European high PE prevalence population, it has been showed that PERC rule used alone or associated with low clinical probability assessed by revised Geneva score (RGS) was not safe. In retrospective study, we suggest that the combination of PERC rule with implicit clinical probability (gestalt) could allow the use of the PERC rule.

PERCEPIC, an observational prospective multicenter study performed in France and Belgium, will test this hypothesis. Therefore, 3000 patients will be included in 12 centers. Primary outcome will be the rate of thromboembolic events or death related or possibly related to PE in patients with low implicit clinical probability and negative PERC rule (8 criteria absents). Upper limit of confidence interval of this rate must be equal or lower than 3% to consider PERC rule as safe in this combination.


Eligibility Criteria:
Inclusion Criteria:

- Patients admitted to the emergency department for one of the following criteria :

* Dyspnea and/or Thoracic pain without another obvious cause
* Pulmonary embolism suspicion whatever the reason

Exclusion Criteria:

* Age lower than 18
* Patients hospitalized for more than 48h
* Ongoing curative anticoagulant therapy for more than 48h before admission
* Patients with thromboembolic disease diagnosed before the admission
* Unavailability for follow-up (short life expectancy, no phone number...)
* Patient refusing to be contacted by phone at 3 month
* Patient refusing that medical data were collected
* Secondary exclusion criteria : curative anticoagulant therapy for more than 5 days during the 3 month follow-up for another reason than thromboembolic disease.
Efficacy of Micronized Natural Progesterone Vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.

This study aims to investigate if the use of oral micronized natural progesterone is not inferior to the use of subcutaneous antagonist in preventing LH peak in controlled ovarian stimulation.

The study will aim to include 150 women (egg donors): 75 per group and the principal variable will be the number of retrieved mature (MII) oocytes. Randomized, prospective, controlled, single center, phase IV study.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility for the oocyte donation program at Instituto Bernabeu.
* Age between 18 and 33 years
* BMI \>18 and \<30
* Overall antral follicle count \>8
* Presence of both ovaries
* Ability to participate and comply with the study protocol
* Oral and written comprehension of Spanish
* Having given written consent

Exclusion Criteria:

* Endometriosis at any stage
* Any ovarian tumor whether benign or malignant
* Concurrent participation in another study
* Malabsorptive syndromes that may alter the efficacy of Seidigestan ® such as bariatric surgery, ulcerative colitis or Crohn's disease
* Irregular periods
* Hypogonadotropic hypogonadism
* Having received in the previous two months treatment with ovulation stimulators
* Having previously participated in the present study
The Effect of the Formative Assessment Method Applied in the Fundamental of Nursing Course

In nursing education, the course where students encounter these gains for the first time and which forms the basis for other professional courses is generally the Nursing Fundamentals Course. In order to develop psychomotor skills within the scope of the Nursing Fundamentals Course, models are used to include practical studies in skill laboratories after the theoretical explanation of the course. Formative evaluation, one of the evaluation methods, is a process that provides clear feedback in teaching, regulates learning, and aims to improve the student's success in the educational outcome. The main purpose here is to review the learning and teaching process. Efforts are made to obtain feedback on situations that are disrupted in the learning-teaching process, incomplete learning, difficulties in learning, and situations in which improvement is needed. The feedback obtained in this evaluation is developmental for both the student and the instructor. Therefore, formative assessment is one of the important elements of reflective learning and teaching. With this research, students will be evaluated with a standard exam to determine whether they have achieved the expected proficiency levels in their knowledge and skills and whether the educational program has achieved its goals. This exam aims to measure students' self-efficacy by creating an example that can be used in other education and training institutions.

Students will be assigned to experimental and control groups by random route sampling method according to their internship locations.

A survey and a check-list for each nursing skill practice will be used in the research.

Self-Efficacy Survey in the Most Commonly Used Skill-Requiring Practices in Nursing; It will consist of 4 questions containing personal information and 6 questions listing nursing skills determined in line with the literature. Additionally, a check-list will be prepared for 6 nursing skills.


Eligibility Criteria:
Inclusion Criteria:

* Taking a nursing fundamentals course
* Volunteering to participate in the study
* Being over 18 years old

Exclusion Criteria:

* Dropping out of the fundamentals of nursing course
* Filling out forms incompletely
Eyhance Autorefraction Study

Since 2018, the Tecnis Eyhance ICB00 lens (Johnson\&Johnson Vision, AMO Germany GmbH) was introduced, which is a monofocal IOL which has the ability of extended depth of focus improving intermediate vision without the photic phenomena specific for the multifocal IOLs. The Tecnis Eyhance ICB00 is one of our standard IOL, routinely used in our clinic. There is no single outcome measurement that can be thought of as summarizing the efficacy of an IOL, nevertheless visual acuity and refractive outcome are the most important parameters for evaluation. Aim of this study is to determine the comparability and reproducibility of different refraction methods in patients implanted with Eyhance lens and compare the outcomes with ZCB00 lens.

This a prospective observational study that would include pseudophakic patients that have undergone cataract surgery 2 to 12 months prior. A written informed consent will be obtained from each patient. Patients with ICB00 or ZCB00 implanted lenses will be included.

Autorefraction measurements will be performed consecutively, each patient will be measured three times with each device. Two independent observers will perform subjective refraction and will be masked to the autorefraction outcome.

We would like to include 50 eyes with ICB00 and 50 eyes with ZCB00 lens implanted. For the estimation of sample size, we used data from Wang et al. (Wang L, Misra M, Palikaris IG, Koch DD. J Cataract Refract Surg 2002; 28: 276-282) that compared the refractive outcome of pseudophakic eyes and determined a mean spherical equivalent of -0.76 + 0.96 D for group I and -0.44 + 1.13 for group II, thus leading to an effect size of 0.2. The effect size was used for ANOVA test for repeated measurements within factor, with alpha \< 0.05, power of 80% and a correlation of 0.5 between the two groups gave us an estimated of sample size of 42 patient. To allow patient drop out a number of 50 eyes will be included per lens group (in total 100 eyes).

When different lenses are implanted (one eye received ZCB00 and the other Eyhance), than both eyes of the patient will be included.

Eligibility Criteria:
Inclusion Criteria:

* 21 years old or above
* Operated age-related cataract (pseudophakic patient)
* Tecnis Eyhance ICB00 or Tecnis ZCB00 IOL implanted within 2 to 12 months prior to study related examination

Exclusion Criteria:

* Intra- or Postoperative complication
* patients with severe corneal pathology, severe macular degeneration, severe diabetic retinopathy, etc. that would significantly influence visual outcome
* nystagmus or pathologies that would affect patient fixation
* pregnancy- for women in reproductive age a pregnancy test will be performed.
Aquablation in Benign Prostatic Hyperplasia in Canada

To document the clinical outcome of Aquablation therapy for BPH patient in Canadian cohort.

Patients will be followed up for 3 years as standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Benign Prostate Hypertrophy (BPH)
* Male subjects of ≥ 18 years of age
* Candidate for Aquablation therapy as per clinical decision of Investigator
* Willing and able to accurately complete questionnaires
* Willing and able to provide signed and dated informed consent

Exclusion Criteria:

* Characteristics indicating a poor compliance with study protocol requirements.
* Disease or other health condition that is not suitable for this study.
* Unable or unwilling to provide signed informed consent.
Rates of Recovery From Strenuous Exercise in Physically Active Older Adults

The purpose of this study to determine if older adults who are healthy and physically active (i.e., Masters athletes) demonstrate slower rates of recovery from unaccustomed strenuous exercise of downhill running than younger peers.

There is a well-conceived notion that the recovery from strenuous exercise gets slower as individuals get older in age. Studies using animal models have demonstrated that stretching of electrically-activated skeletal muscle to mimic eccentric muscle contractions results in a greater decline and slower recovery in muscular force in old mice than in young mice. Similarly, in human studies using sedentary adults, age has been associated with a slower rate of recovery from a series of eccentric contractions. However, the process of aging is often confounded by coexisting diseases and gradual sedentary lifestyles that progress with advancing aging. Could older adults who are apparently healthy and habitually exercising demonstrate slower rates of recovery from strenuous exercise? In a small-scale study, recreationally-active middle-aged adults did not display a slower recovery from unaccustomed eccentric exercise than young adults. Masters athletes are an effective experimental model to address this question as extrinsic factors (e.g., deconditioning, chronic degenerative diseases) that often confound the intrinsic aging process can be minimized in this population. As no study has been conducted in Masters athletes, it is unknown if Masters athletes would experience slower rates of recovery similar to their sedentary peers.

With this information as background, the general aim of the proposed study is to determine if older adults who are healthy and physically active demonstrate slower rates of recovery from unaccustomed strenuous exercise of downhill running than younger peers. In an attempt to properly determine the influence of aging and regular physical activity, 4 groups of apparently healthy adults, including young sedentary, young trained, older sedentary, and older trained adults, will be studied.

A total of 60 apparently healthy men and women will serve as subjects. Half will be young \[18-40-year-old (n=30)\] and the other half older \[50-80-year-old (n=30)\]. After the screening and familiarization, investigators will ask participants to visit the laboratory four times (four consecutive days) to perform downhill running and to test physiological measurements (muscular strength, pain scale, range of motion, arterial stiffness and blood pressure and blood creatinine and myoglobin concentrations).

Eligibility Criteria:
Inclusion Criteria:

* Sedentary (exercise \< 1 time/week) or well-trained individuals (exercise ≧ 2 times/week)
* Ages 18-39 and 50-80 years
* Individuals who can safely exercise

Exclusion Criteria:

* Individuals who reports "Symptoms or Signs Suggestive of Disease" on the Health Research Questionnaire (heart and respiratory problems, dizziness and ankle edema).
* Individuals who report substance abuse within the last 6 months (elicit drugs, alcohol)
* Smokers
Risk of NSAIDs on Anastomotic Leak for Rectal Surgery

Conflicting reports of the association between early postoperative non-steroidal anti-inflammatory drugs (NSAIDs) administration and anastomotic leak (AL) after rectal surgery have continued. The definition of AL and the exposure of NSAIDs differ from each other among studies, which may result in the different conclusions.

The aim of this retrospective study was to clarify the effect of NSAIDs on anastomotic leak from new angels.

Concerning about the side effects induced by opioids, nonsteroidal anti-inflammatory drugs (NSAIDs) have gained its popularity in ERAS protocols. NSAIDs competitively inhibits the activity of cyclooxygenases (COXs), which are involved in migration of epithelial cell and mucosal restitution, angiogenesis and collagen synthesis during healing. Conflicting reports of the association between early postoperative non-steroidal anti-inflammatory drugs (NSAIDs) administration and anastomotic leak (AL) after rectal surgery have continued.

Notably, the definition of AL and the exposure of NSAIDs (i.e. NSAIDs administration) differ from each other among the studies, which may result in the different conclusions. In concrete terms, the definition of NSAIDs administration timing varies from the first day to the first week after surgery, while the AL was also defined in multiple ways (timing varies from 14 to 90 days postoperatively, or only leaks with operative intervention included). Most previous studies suggested that early and late AL are different entities with different risk factors. These interesting evidences indicate reconsidering the effect of NSAIDs on AL is needed.

Hence, investigators defined the NSAIDs administration as at least once in the early postoperative period--the day of and the day after surgery (NSAID group), to avoid the inclusion of patients started on NSAIDs secondary to a complication. At the same time, investigators also classified AL into early AL (confirmed within 6 days) and late AL (over 6 days). Moreover, concerning the higher rate of AL in rectal surgery than colonic surgery and the trend of minimally invasive surgery, investigators performed the current study, aiming to clarify the association between early postoperative NSAIDs and anastomotic leak in rectal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven adenocarcinoma of the rectum
* Age over 18 years old
* Patients underwent non-emergency minimally invasive surgery with a primary anastomosis

Exclusion Criteria:

* Incomplete medical records
* Patients with distant metastasis before surgery
* Patients with multiple primary colorectal carcinomas