cyrilzakka/clinical-trials huggingface dataset:
Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection

The incidence of C. difficile infection (CDI) has alarmingly increased over the past several years and the affected population has expanded to include those previously at low risk, such as children. The annual US financial burden associated with this infection is great and estimated to exceed $1.8 billion. C. difficile infection arises when the gut microbial ecology is disrupted during interventions notorious for perturbing the delicate microbial balance. A well known and common example is the use of antibiotics. Fecal microbiota transplant (FMT) has been introduced several decades ago in an attempt to restore the gut microbial balance. To this date there have been a great number of reports of success in eliminating recurrent C. difficile infections and restoring the gut microbial profile to resemble that of the healthy donor. While over 300 cases have been described in the literature, there has been no pediatric controlled studies performed to compare its efficacy to placebo. Therefore, there is a strong need to determine their safety and efficacy in pediatric randomized controlled studies. The investigators hypothesize that children with recurrent C. difficile infection will respond to fecal transplant therapy which will modify their gut microbial profile. The investigators propose a randomized, placebo controlled, pilot study of fecal microbial transplant in children with recurrent C. difficile infection to evaluate the safety and efficacy of fecal microbial transplant in children in preventing recurrent C. difficile infection. The investigators anticipate that fecal microbial transplant in children with recurrent C. difficile infection will be safe and efficacious and will provide these children with a great alternative to a disease that is difficult to treat. Results of this study will establish the major role of the gut microbiome in this disease and demonstrate the viability of gut microbial transplant in recipients.

Forty six children with recurrent C. difficle infection will be randomized 1:1 to receive either fecal microbial transplant or placebo. The safety and efficacy of this intervention will be monitored for one year.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 1-21.
2. Recurrent C. difficile infection defined as the occurrence of more than two infections

Exclusion Criteria:

1. Inflammatory bowel disease
2. Immune-deficiency.
3. Allergy to oral vancomycin.
4. Children colonized with Clostridium difficile without evidence of symptoms to suggest colitis such as diarrhea and/or rectal bleeding.
5. Concurrent infections that require anti-microbial therapy.
6. Unable to give informed consent/assent.
7. Pregnancy.
Extension Study of Long-term Safety and Efficacy of Myozyme for a Single Patient With Pompe Disease Who Were Previously Enrolled in Genzyme Sponsored ERT Studies.

This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in a single patient with infantile-onset Pompe disease who were previously treated with rhGAA in a Genzyme study.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent prior to participating in any study related procedures;
* Currently enrolled in Protocol AGLU01402
* Have the ability to comply with the clinical protocol, which required extensive clinical evaluations for an extended period of time.

Exclusion Criteria:

* Was pregnant or unwilling to use approved birth control during the course of the study;
* Had experienced any unmanageable AEs under Protocol AGLU01402 (as determined and agreed upon by the Principal Investigator and sponsor) due to rhGAA that would preclude continuing ERT;
* Was participating in any other investigational study.
Comprehensive Nursing Care Protocol for Women With Pelvic Organ Prolapse and Urinary Incontinence: A Global Perspective

Pelvic organ prolapse is the descent of pelvic structures into the vagina due to ligament or muscular weakness. Pelvic organ prolapse (POP) is subcategorized according to the compartment of descent. Cystocele characterizes anterior wall herniation, rectocele refers to the posterior vaginal wall descent, and vaginal vault prolapse characterizes the descent of the uterus, cervix, or apex of the vagina. They can occur either singly or in combination

this study aimed to investigate the effectiveness of a comprehensive nursing care protocol provided for nurses who provide direct care for women with pelvic organ prolapse and urinary incontinence in gynecological in patients departments, Mansoura University Hospital, Mansoura University on their knowledge and practices as well as its impact on the women quality of life.

Eligibility Criteria:
Inclusion Criteria:

* All available nurses assigned for bed side care in the previous study settings and fulfilled the following inclusion criteria:

  * Age 20≥ 60 years
  * Willing to participate in the study
  * Both sex

Exclusion Criteria:

* nurses did not assign for bed side care in the previous study settings and not fulfill the inclusion criteria
Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma

Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.

The purpose of this study is to evaluate the efficacy and tolerability of Beclomethasone Dipropionate/Formoterol single inhaler in a twice daily regimen in patients with mild to moderate persistent asthma. Patients are randomised to receive either Beclomethasone Dipropionate/ formoterol single inhaler (total daily dose : BDP/FF 400/24 µg) or Beclomethasone CFC (total daily dose : BDP 1000 µg) during 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild to moderate persistent asthma (according to GINA 2003 guidelines)
* FEV1 \> or = 60% and \< or = 85% of predicted normal values
* Patients free of LABA at least for one month before screening and already treated for at least two months with ICS and experiencing (i)a daily use of SABAs between 1 and 4 puffs, (ii) and/or clinical symptoms three times in the week prior to inclusion
* A documented positive response to the reversibility test

Exclusion Criteria:

* Pregnant or lactating females or women of childbearing potential without any efficient contraception
* Heavy smokers defined as smoking for \> 10 pack years
* Evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids)
* Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer
* Clinical significant or unstable concomitant diseases, including clinically significant laboratory abnormalities
* Evidence of asthma worsening during the week preceding randomisation (e.g PEF variability \> or = 30% during 2 consecutive days, SABA use \> 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days
Study of the Change of Breast Cancer Patients' Upper Limb Lymphatic Drainage Pathway After Operation

Lymphoscintigraphy is a noninvasive，accurate and effective imaging modality. In this study, it is used to investigate the imaging characteristics of patients'upper limb lymphatic drainage before operation, and the influence of operation on it.

The global burden of breast cancer continues to increase largely because of the aging and growth of the world population. More than 1.38 million women worldwide were estimated to be diagnosed with breast cancer in 2008, accounting for 23% of all diagnosed cancers in women. Given that the 5-year survival rate for breast cancer is now 90%, experiencing breast cancer is ultimately about quality of life. Women treated for breast cancer are facing a life-time risk of developing lymphedema, a chronic condition that occurs in up to 40% of this population and negatively affects breast cancer survivors' quality of life. It's becoming more and more important to do more research on the breast cancer-related lymphedema. Axillary reverse mapping (ARM) is a technique used to map arm lymphatic drainage during axillary lymph node dissection (ALND) and/or sentinel lymph node dissection (SLND). It's necessary for the investigators to understand the participants' upper limb lymphatic drainage before operation and what the investigators have done on it during operation. It can be easy to understand the influence of operation on the participants' upper limb lymphatic drainage, the possibility and safety of reserving lymph nodes draining the upper extremity lymph.

Eligibility Criteria:
Inclusion Criteria:

For inclusion in the study patients must fulfil all of the following criteria:

1. Diagnosed with breast cancer
2. There is no metastasis except axillary nodes
3. Agree to receive Lymphoscintigraphy of upper extremity

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from the study:

1. Pregnancy or lactation
2. Inflammatory breast cancer
3. Disagree to receive Lymphoscintigraphy of upper extremity
4. History of axillary lymph node resection
Analgesia for 2nd Trimester Termination of Pregnancy

There has been very little investigation into the management of pain from 2nd trimester termination of pregnancy or unexpected fetal loss. The standard of practice in North America is usually intravenous patient controlled analgesia (IV PCA), using a narcotic wuch as fentanyl. The goal of this study is to compare the quality of recovery after termination of pregnancy using fentanyl IV PCA or patient controlled epidural analgesia (PCEA), a standard of care for live births. The study will be conducted as a randomized controlled trial.

Epidural analgesia is known to provide superior analgesia for labour with minimal maternal and fetal side effects. This mode of analgesia is not usually offered to patients who require termination of their pregnancies or who suffer unexpected fetal losses, although they go through labour and delivery with likely more difficult psychological circumstances.

We plan to compare patient controlled epidural analgesia (PCEA) with intravenous patient controlled analgesia (IV PCA), for 2nd trimester terminations of pregnancy. We hypothesize that PCEA provides better quality of recovery than IV PCA. The previously validated Quality of Recovery - 40 questionnaire will be used to measure a patient's quality of recovery. The results of this study will determine the optimal method of pain relief for late termination of pregnancy or fetal loss.

Eligibility Criteria:
Inclusion Criteria:

* interruption of pregnancy between 12 and 23 6/7 weeks

Exclusion Criteria:

* documented allergy to fentanyl or bupivacaine
* coagulopathy
* drug or narcotic abuse
* contraindication to neuraxial analgesia
* inability to comply with IVPCA or PCEA
* inability to complete the QoR-40 questionnaire
* TOP due to maternal problems
Effect of Carnitine Supplementation and Resistance Training on Skeletal Muscle Function

The primary aim of the current research project is to explore whether nutritional supplementation and resistance training might be combined to produce synergistic effects in the prevention of muscle loss during aging.

A secondary aim of this project is to investigate the effects of carnitine with leucine supplementation, in comparison to carnitine supplementation alone, on muscle strength and body composition.

The hypothesis is that resistance training combined with nutritional supplementation have a more beneficial effect than resistance training alone in the prevention of muscle loss during aging. Leucine stimulates carnitine transport into the muscle cells, which improve mitochondrial capacity. Modification in energetic of skeletal muscle affects the body composition and muscle performance.

The study will be included volunteers - women between 60 - 72 years old (n=60). The patients are randomly assigned to two experimental groups (n=20) and control group (n=20). During the 24-weeks intervention period, Group A undergoes training procedure supplemented with the carnitine and leucine, whilst group B undergoes training procedure supplemented with leucine. At the same time control group go through only training procedure. Measurements are performed before, at the mid-point, and at the end of the intervention period.

Approximately 1 week prior to the experimental trial day, participants perform a familiarization session during which one-repetition maximum (1RM) strength testing is also performed to determine the experimental exercise load. Resistance exercise training is performed twice weekly on non-consecutive days (Monday+Thursday, or Tuesday+Friday) for 24-weeks under direct supervision by a research assistant. Prior to a training session subjects are required to perform warm - up on the treadmill (walk) and static stretching, after each session - cool down on the cycle ergometer and static stretching. Resistance exercise for each session consisted of 6 exercises: horizontal seated leg press, seated chest press, leg extension, shoulder press, lat pull-down seated row, seated cable row First two weeks of training consist of 3 sets of 10-12 repetitions and are keeping exercises at 65% of 1 repetition maximum (1RM). After this period training consists of 3 sets of 6-8 repetitions and is progressing to 80% of 1RM. The 1RM is re-evaluated every 2 weeks, and the training load is adjusted accordingly. The exercise program follows the recommended guidelines for older adults by the American College of Sports Medicine and the National Strength and Conditioning Association.

Eligibility Criteria:
Inclusion Criteria:

* aged-matched, no chronic disease, doctor's note about the lack of restrictions to perform resistance exercises

Exclusion Criteria:

* diabetes, liver, heart and renal diseases, gastric problems, as well as using the vitamin supplements
Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction

Prospective investigation of the effectivity of L-PRF membranes for skull base reconstruction after endoscopic endonasal skull base surgery (transsphenoidal) versus classical closure techniques.

The investigators want to demonstrate in a prospective, randomized trial including 220 patients undergoing endoscopic endonasal skull base surgery that the use of L-PRF is non-inferior to classical fibrin sealants.

Approximately 220 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded multicenter study to evaluate the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lesions of the sellar/parasellar region
* Age \> 18 and \< 70 years
* Written informed consent
* Willingness to adhere to visit schedules

Exclusion Criteria:

* Age \< 18 and \> 70 years
* Any underlying rhinological condition like nasal polyps, which may interfere with the obtained results
* Any disorder which might compromise the ability of a patient to give truly informed consent for participation in this study
* Enrollment in other investigational drug trial(s)
Influence of Platform-switching on Bone Level Alterations: a 3 Year Randomized Clinical Trial (RCT).

The concept of platform-switching has been introduced to implant dentistry based on clinical observations of reduced periimplant crestal bone loss. However, published available data are controversial and most studies are limited to 12 months. The aim of the present RCT was to test the hypothesis that platform-switching has a positive impact on crestal bone level changes after 3 years.

Two implants with a diameter of 4 mm were inserted crestally in the posterior mandible of 25 subjects. After three months of submerged healing, single-tooth crowns were randomly placed, either with (3.3mm platform, test) or without platform-switching (4mm platform, control). Patients were followed up at short intervals for monitoring of healing an oral hygiene. Statistical analysis for the influence of time and platform-type on bone levels employed the Brunner-Langer Model.

Eligibility Criteria:
Inclusion Criteria:

* good general health
* edentulous gap in the posterior mandible for placement of 2 implants
* sufficient bone height above the alveolar nerve for placement of implants with a height of 9.5mm
* bone width for placement of implants with diameter of 4mm
* at least 4mm keratinized mucosa
* medium or a thick soft tissue biotype

Exclusion Criteria:

* infectious disease
* diabetes or osteopathy
* active periodontitis
* medication influencing bone metabolism
* lactating or pregnant women
Evaluation of the F&P Caramel Nasal Mask, US, 2023

The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Caramel nasal mask in a home environment.


Eligibility Criteria:
Inclusion Criteria:

* Persons who are ≥22 years of age
* Persons who weigh ≥66 pounds
* Persons who have been prescribed PAP therapy by a physician
* Persons who are existing nasal mask or sub-nasal mask users with ≥3 months of use prior to enrolment in the clinical trial
* Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial
* Persons who are fluent in spoken and written English
* Persons who possess the capacity to provide informed consent

Exclusion Criteria:

* Persons who are intolerant to PAP therapy
* Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
* Persons who are required to use PAP therapy for \>12 hours per day or for extensive periods, not including sleep or naps
* Persons who are trying to get pregnant, are pregnant, or think they may be pregnant
* Persons who have an IPAP pressure of \>30 cmH2O if on BPAP
* Persons who use a PAP therapy device for the delivery of medicines, except supplemental oxygen
* Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site
Cervical Motor Control Exercises in Strength and Perception of Effort in Electronic Sports Players

Introduction. One of the most common injuries in competitive esports professionals is dorsolumbar and neck pain, due to the effort caused by the maintenance of the site for long periods of time. Cervical motor control exercises recruit the deep musculature by increasing its strength and reducing muscle fatigue.

Aim. Evaluate the effectiveness of motor control exercises in cervical muscle fatigue and strength, in electronic athletes from 18 to 25 years.

Study design. Randomized clinical trial, simple blind. Methods. 30 electronic athletes will be randomly assigned in two groups: experimental (which will perform 3 sessions of 3 motor control exercises) and control (which will not perform any type of intervention). The intervention will last 6 weeks, with 3 weekly sessions of 10 minutes each. The study variables are the muscle strength of the deep cervical muscle (measured by a stabilizer pressure gauge) and the subjective perception of the effort (Borg scale).

Expected results. The aim is an improvement in the muscular strength of deep cervical muscles, together with a decrease in subjective perception of exertion.


Eligibility Criteria:
Inclusion Criteria:

* Electronic sportsmen
* Male sex
* From 18 to 25 years
* That at the time of the study participate in national competitions
* That they have not suffered a musculoskeletal pathology in the last 4 months.

Exclusion Criteria:

* Athletes taking anti-inflammatory drugs that may influence the intervention
* Players who are allergic to nylon (main component of the evaluation device)
* That they have not signed the informed consent document.
Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis

This study will represent the sponsor's first controlled study of etanercept in Chinese subjects with Ankylosing Spondytitis (AS). This trial is designed to assess the safety and efficacy of etanercept compared to placebo in the treatment of patients with AS.

Multicenter, double-blind, randomized, parallel and placebo-controlled outpatient study. The study consists of 2 parts: part A is a 6-week double-blind treatment period and part B is a 6-week open-label treatment period. During part A of the study, subjects will be randomly assigned to 1 of 2 treatment regimens: 2 etanercept 25 mg or placebo once weekly, administered subcutaneously (SC). After the completion of part A, all subjects will receive 2 etanercept 25 mg once weekly. The use of placebo as a control in part A is necessary to allow a valid comparison and to provide a quantitative assessment of effect.

Eligibility Criteria:
Inclusion Criteria:

1. Must be of Chinese ancestry and living in China.
2. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
3. Active AS at time of enrollment, defined by average of visual analog scale (VAS) values for duration and intensity of morning stiffness 30 and two of the following: VAS for patient global assessment 30; average of VAS for nocturnal and total pain 30; BASFI greater than or equal to 30 (all scores on a scale of 0 to 100).

Exclusion Criteria:

1. Complete ankylosis (fusion) of spine.
2. Previous treatment with etanercept, antibody to Tumor Necrosis Factor a (TNFa), or other TNFa inhibitors or other biologic agents.
3. Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Subjects treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
Healthy Volunteer Study to Assess Microcirculatory Function

The aim of the study is to obtain microvascular data from a healthy, heterogeneous population for assessing reference values for the parameters Functional Capillary Density (FCD), heterogeneity of FCD, Microvascular Oxygen Saturation (SmvO2) and Heterogeneity of SmvO2 for healthy adults with respect to gender, age, and skin type (Fitzpatrick scale)

Primary objective:

• Obtain reference data of the studied microvascular parameters in a healthy, heterogeneous population

Secondary objectives:

* Determine the reproducibility of the parameters obtained using the device produced by ODI Medical
* Confirm the safety of the device produced by ODI Medical

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Subjects without signs or symptoms of acute or chronic disease and that are not treated with regular medication (contraceptive pills/IUD and oestrogen medication for menopausal symptoms are allowed). Pregnant women can be included.

Exclusion Criteria:

* Regular smokers
* Misusers of alcohol
* Misusers of drugs
* Not intact skin or reddening in the region of interest