cyrilzakka/clinical-trials huggingface dataset:
Antireflux Efficacy of Hiatal Hernia Repairs in Sleeve Gastrectomy Patients

Gastroesophageal reflux (GR) occurrence or persistence following a sleeve gastrectomy (SG) can be correlated to several factors but it is clear that one of the key factors is a persistent hiatal hernia or laxity of the esophageal hiatus. However, there are no clear guidelines presently available on surgical management of small size hernias or an abnormal hiatus. Therefore, hiatal hernia management is decided intraoperatively by the operating surgeon. The main goal of this study is to evaluate the efficacy of primary hiatal hernia repairs on gastroesophageal reflux concomitant to sleeve gastrectomy. The secondary objectives are hiatal hernia recurrence following primary surgery and the occurrence of "de novo" GR.

Background :

The Sleeve gastrectomy (SG) is the most common bariatric procedure worldwide because it is the simplest to perform, from a technical standpoint, and the most efficient in terms of metabolic control and weight loss. However, this intervention can lead to several complications, including the onset or intensification of gastroesophageal reflux (GR) with the associated impact on the patients' quality of life and a possible evolution into Barrett's esophagus. One of the key factors in the development of this complication is a persistent hiatal hernia.

Aims: The main objective of this study is to provide an objective evaluation of the effect of primary hiatal hernia repair on GR concomitant to sleeve gastrectomy. The secondary objectives are hiatal hernia recurrence following primary surgery and the occurrence of "de novo" GR.

Methods :

A total of 100 patients will be recruited for the pilot study, with 50 patients in the SG group and 50 in the SG + primary hiatal hernia repair group following randomization. Then, based on a sample size study, recruitment will be continued as needed. None of the procedures performed are experimental. All obese patients with a BMI between 35-50, aged 18-65 and undergoing surgery for a SG in the institution's bariatric surgery department will be eligible to participate in this study. Exclusion criteria will be hiatal hernias greater than 2 cm, a hiatal repair requiring a drain, prior bariatric surgery or any other counterindication to SG. All patients will be evaluated preoperatively using: 1) EGD, 2) esophageal manometric study, 3) pH assessment and 4) validated GR questionnaires (GERD-HRPL; GCSI). Iconographic intraoperative data on hiatal morphology and the type of cure used will be collected and records will be kept according to Ethics committee guidelines. After a 6-month follow-up the participants will undergo the same tests, including questionnaires, for a medium-term profile.

Eligibility Criteria:
Inclusion Criteria:

* All obese patients with a BMI between 35-50
* Aged 18-65 and undergoing surgery for a Sleeve Gastrectomy in institution's bariatric surgery department

Exclusion Criteria:

* hiatal hernias greater than 2 cm,
* hiatal repair requiring mesh placement
* prior bariatric surgery or any other counterindication to Sleeve Gastrectomy
Prospective Assessment in Newborns for Diabetes Autoimmunity

This is an observational study designed to help researchers understand the genetics and pathogenesis of type 1 diabetes, and to identify biomarkers for disease and disease complication prediction.

This study is designed to identify people who are at risk for developing type 1 diabetes, based on their genetics, family history and autoimmunity status, and to understand the role genetics plays in the development of the complications associated with type 1 diabetes in patients already affected by type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria: all are welcome -

Exclusion Criteria:

-
Nebulized PL for Post-COVID-19 Syndrome

To evaluate and compare nebulized platelet lysate to placebo control of saline administered via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in patients with post-COVID-19 ARDS syndrome.

This is a double-blind, randomized, placebo controlled single-center study using nebulized platelet lysate compared to placebo control of saline administered via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in patients with post-COVID-19 ARDS syndrome.

20 patients randomized to Treatment group: Inhaled nebulized platelet lysate (PL) 1x daily for eight weeks 20 patients randomized to Control group: Inhaled nebulized saline, 1x daily for eight weeks.

Outcomes will be measured at 4-weeks, 8-weeks, 3-months, 6- months

Goals for this study are as follows:

1. Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic nebulizer, 2-ml once per day for 4-weeks compared to saline control (Phase 1), early treatment timepoint.
2. Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic nebulizer, 2-ml once per day for 8-weeks compared to saline control (Phase 1), final treatment timepoint.
3. Investigate, compare, and monitor long term function and quality of life through 6-months for treatment arm compared to control.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary signature of the IRB approved Informed Consent
2. At least 4-weeks post ventilator or oxygen dependent ARDS treated for at least 48 hours in the ICU
3. Patient is stable enough to have been discharged home
4. Male or female ages 18-85
5. Two weeks to 1-year post hospital discharge
6. Ongoing activity intolerance due to dyspnea related to ARDS
7. Is independent, ambulatory, and can comply with all post-operative evaluations and visits
8. 6-minute walk test distance of \< 450 M
9. SF-36 physical component score \< 60
10. ARDS caused by viral pneumonia including COVID-19 confirmed through an RNA anti-body test
11. Normal to mild post-ARDS reactive airway disease

Exclusion Criteria:

1. Oxygen dependent on nasal canula greater than 2-L per minute
2. Dependent on inhaled corticosteroid at the discretion of the physician
3. Unable to complete any of the outcomes measured (Spirometry, 6MWD, SF-36, etc.)
4. Active known secondary bacterial or viral infection
5. Active moderate or severe post-ARDS reactive airway disease at the discretion of the physician
6. Pre-morbid COPD
7. Medication list will be reviewed on a case by case basis to allow for flexibility as post-COVID-19 patients' medication list may vary
8. Other medical comorbidities/conditions that may preclude participation in the study
Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain

Although approved for minor strains, sprains and contusions, FLECTOR Patch has not been studied extensively in the setting of acute back strain. This study is being conducted as an initial step in demonstrating the benefit of FLECTOR Patch specifically for back strain. In particular, this study is expected to provide information about the amount of improvement in back strain among subjects using the FLECTOR Patch, which may then be used to inform subsequent studies.


Eligibility Criteria:
Inclusion Criteria:

Participants in the study must:

1. have acute, non-radicular back strain with onset up to 10 days before the first visit
2. have intact, non-damaged skin at the proposed patch application site
3. be untreated or unresponsive to conservative pain treatment regimens and/or opioids
4. have a minimum pain intensity score of four (4) or more on a scale of 1-10 (a rating of zero (0) being "no pain" and a rating of ten (10) being "pain as bad as you can imagine")
5. have a normal neurologic examination

Exclusion Criteria:

Participants may not be in the study if they:

1. have had surgery or other chronic pain condition within 3 months before first treatment
2. have back pain radiating below the knee at time of enrollment
3. have neuropathic pain or have been treated with gabapentin or pregabalin for neuropathy
4. are being treated for or are known to currently have kidney or liver disease
5. have certain other diseases or are using certain types of other drugs.
The Effect of Fascia Therapy and Transcutaneous Fibrolysis on Acute Ankle Sprain

This study investigates the immediate effect of fascia therapy and transcutaneous fibrolysis in the treatment of an acute ankle sprain. These treatments will be compared to a placebo group.

Ankle sprain is the most occurring sport related injury. In spite of the high prevalence of this injury and the often residual symptoms, there is a large variety in diagnostic approach and therapeutic protocols. Concerning the treatment of an acute ankle sprain, it remains a challenge to minimize injury consequences on short and long term.

In this study we investigate the immediate effect of two therapeutic techniques: fascia therapy and transcutaneous fibrolysis. They will be compared to a third group, who receives a placebo treatment. Muscle strength, muscle vascularisation, muscle tenderness and joint position sense are measured before and after treatment.

The purpose of this study is to contribute to the knowledge of treating acute ankle sprains.

Eligibility Criteria:
Inclusion Criteria:

* acute ankle sprain

Exclusion Criteria:

* none
Proton Radiotherapy for Recurrent Tumors

The purpose of this study is to determine the feasibility of using proton radiotherapy for reirradiation of recurrent malignancies.

Patients will be stratified by treatment site (Head and Neck, Thorax, Abdomen, Pelvis, Extremities) and by treatment volume (low volume, high volume) for a total of 10 strata. This study will be done in two phases. In the first phase, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 90 days after the last patient in the initial phase has completed treatment in each strata and once feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed, non-CNS solid malignancies who have been previously radiated and have a tumor recurrence in or near prior radiation fields. Re-biopsy of the recurrence is not required and left to the discretion of the treating physician, although every effort should be made to confirm recurrence.
* Patients must have a Karnofsky Performance Status of 60. Life expectancy of 3 months .
* Age greater or equal to 18.
* Patients must be able to provide informed consent.
* Women of child bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods, etc.)
* Hysterectomy or menopause must be clinically documented.

Exclusion Criteria:

* Prior radiation treatment less than 3 months from planned start of re-irradiation of any part of the intended treatment volume.
* Pregnant women, women planning to become pregnant and women that are nursing.
* Actively being treated on any research study.
Comparison Between Functional and Analytic Methods to Strengthen Shoulder Rotators and Scapular Muscles

The objective of the study was to compare analytic, functional and mixed (analytic/functional) methods in strengthening rotator cuff and scapular stabilizers muscles. For that purpose, participants had to follow a strengthening program 3 times a week during 8 weeks.

Each participant was allocated to a group (analytic, functional and mixed groups) in a random way while assuring that the groups were quite similar in morphological data or in performance. The strengthening program has to be performed three times a week during eight weeks by each participant.

The exercises included in the program were chosen among the bests exercises described in literature to active shoulder rotators as well as scapular stabilizing muscles. The analytic group has to perform the following exercises: prone rowing with dumbbell, prone external rotation at 90° of abduction, prone extension, bilateral scapular protraction with dumbbells, eccentric internal rotation at 90° of abduction, external rotation diagonal exercise and single arm shot put medicine ball throw. The functional group performed the same exercises but with a functional component: standard plank rowing, swissball external rotation at 90° of abduction, standard plank extension, bilateral scapular protraction (standard plank + raised feet), eccentric internal rotation 90° of abduction with unipodal glute bridge, external rotation diagonal in an unipodal position and single arm shot put throw with medicine ball in and single arm shot put medicine ball throw. Then, for the mixed group, the program included exercises from the analytic group and other ones from the functional group in equal parts. For all the groups, the exercises aimed to strengthen shoulder rotators were performed five times in a row and the others aimed to strengthen scapular stabilizing muscles were performed fifteen times in a row. The only exception was for the single arm shot put medicine ball throw that was performed ten times. Two series of each exercises were performed during each session, which represent a mean duration of thirty minutes.

At the beginning and at the end of the intervention, three different evaluations were performed :

* Measurement of shoulder rotators strength (with an isokinetic device)
* Measurement of scapular stabilizers strength (with an isokinetic device)
* Measurement of functional performance (with Medicine Ball Throw, CKCUEST, Y Balance Test and a core stability test)

Eligibility Criteria:
Inclusion Criteria:

* Males aged between 18 and 35 years old

Exclusion Criteria:

* Practicing an overhead sport
* Having an history of shoulder pain or shoulder surgery in the past 12 months
Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia

The goal of this observational study is to evaluate the clinical efficacy of the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells, and to study the changes of inflammatory response before and after the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells in anemic neonates. The main questions it aims to answer are:

* Objective evaluation of the advantages and disadvantages of transfusion of different blood products in the treatment of neonatal anemia from the clinical efficacy.
* To provide objective basis for clinical rational use of blood in the selection of blood products.

Participants will be transfused with fresh irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells respectively according to relevant clinical and laboratory indicators.


Eligibility Criteria:
Inclusion Criteria:

Neonates with stable hemodynamics who need blood transfusion are comprehensively evaluated by neonatologists according to their clinical conditions (heart, respiratory status, postnatal age, pregnancy at birth), laboratory indicators, etc. Diagnosis of Neonatal Septicemia:

* The mother had chorioamnionitis infection or Premature rupture of membranes (PROM) ≥18 h.
* The clinical diagnosis is that there are clinical abnormal manifestations, and any of the following conditions is met at the same time: ① blood non-specific examination ≥ 2 items are positive, ② cerebrospinal fluid examination is purulent meningitis change, and ③ pathogenic bacteria DNA is detected in blood.
* The diagnosis was confirmed as having clinical manifestations and positive blood culture or cerebrospinal fluid (or other sterile cavity fluid) culture.

Exclusion Criteria:

* Infants with necrotizing enterocolitis (NEC) (current or previous).
* Feeding intolerance (defined as the decision of the treatment clinical team to suspend feeding / suspend feeding for at least 12 hours).
* RBC transfusion in the past 72 hours; Children who received ibuprofen / indomethacin / surgery 72 hours ago and / or severe congenital malformations such as congenital gastrointestinal tract, complex cardiopulmonary / fatal abnormalities or need emergency blood transfusion.
A Study of Telemedicine Shared Medical Appointments (SMAs) Versus Individual Telemedicine Visits for People With Prostate Cancer

The purpose of this study is to see if a telemedicine group doctor's appointment is a practical (feasible) and acceptable method for following people with prostate cancer being managed with active surveillance when compared with the usual approach of individual telemedicine visits, which involve the participant visiting a doctor on their own. The researchers will compare the telemedicine group and individual visits by measuring on participant satisfaction and quality of life in each type of visit. Telemedicine is the use of secure video technology on a desktop computer, laptop, smartphone, or tablet to provide and receive healthcare from a distance.


Eligibility Criteria:
Inclusion Criteria:

* A scheduled appointment for a subsequent Active Surveillance (AS) follow-up visit for management of localized prostate cancer
* Biopsy Gleason score 3+3=6 (Grade Group 1) or biopsy Gleason score 3+4=7 (Grade Group 2)
* Clinical T stage ≤T2B
* Access to a device with Zoom
* Ability to speak and understand English

Exclusion Criteria:

* Plan to undergo a prostate biopsy at this follow-up visit
Therapeutic Research in Multiple Myeloma

The purpose of this study is to learn how myeloma cells grow and become a cancer, how to distinguish them from normal cells and how to eliminate these cells selectively.

Participating in this study will require that blood and bone marrow samples be obtained as a part of the diagnostic work-up or follow-up of your multiple myeloma. Bone marrow/peripheral blood/tissue samples will be collected for research purposes, as well as testing for genetic traits of Castleman's disease if you consent to this study. In addition, data will be collected including demographic information gathered from your medical record, including gender, date of birth, ethnicity, date of diagnosis, laboratory and pathology results, treatment protocols, dates of relapses, subsequent treatment protocols, and current treatments and medications.

Eligibility Criteria:
Inclusion Criteria:

* Any subject evaluated for a MIRT protocol

Exclusion Criteria:

* Subjects who have not been evaluated for a MIRT protocol
Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users

The aim of this study is to establish the connection between the cochlear implant programming parameters with the auditory effort associated with the speech perception evaluated by pupillometry techniques in different audiometric conditions.


Eligibility Criteria:
Inclusion Criteria:

* Users willing to participate in the study with signature and date of the Informed Consent.
* Age between 18 and 70 years old.
* At least 6 months experience with the Neuro Zti implant and Neuro 2 processor.
* Unilateral, bilateral and bimodal users.
* Basic understanding of oral and written Spanish.
* Normal or corrected vision.

Exclusion Criteria:

* Speech or language disorder.
* Added comorbidities or cognitive dysfunction.
* Not approval to participate in the study or absence in some of the programmed sessions for the Cochlear Implant.
Promoting Human Papillomavirus (HPV) Vaccination Through African American Beauty Salons

The investigators propose a non-randomized pilot study to assess the feasibility and effectiveness of using urban beauty salons as settings for culturally-competent health education about HPV vaccination. The educational messages will engage individual women, their peer group, their family members and community influencers in a way that is authentic and share-able. Involving women in give-and-take discussions with people they trust and respect-their hairdressers-will be essential to increasing the number of them who consider the HPV vaccine for themselves and for those they care about. The investigators believe that it is only after women who are opinion leaders among their peers begin positively supporting HPV prevention that it will gain wider acceptance.

The investigators plan to recruit eight (8) predominantly African American beauty salons in Philadelphia and train multiple stylists in each salon to act as in-salon educators and facilitators for client recruitment to sexual health education sessions. These education sessions will be run by trained health educators (also African American females) and take place during "down times" in each of the salons, on a rotating basis.

* The investigators hypothesize the ability to successfully recruit eight (8) beauty salons for participation
* The investigators hypothesize the ability to successfully train multiple stylists per site to talk to their clients about HPV and its impact on women of color
* The investigators hypothesize that knowledge and awareness of HPV, as well as intentions to vaccinate will significantly improve among women who attend a salon-based health education session


Eligibility Criteria:
Inclusion Criteria:

* Mother of an 9-18 year old female
* Female who is 18-26 years old

Exclusion Criteria:

* Not a mother of an 9-18 year old female
* Not a female who is 18-26 years old
Yoga Nidra and Pain After Caesarean Section

The effect of yoga nidra on pain, mobilisation, first walking distance and maternal satisfaction after caesarean section

The aim of this study is to investigate the effect of yoga nidra on pain, mobilisation, first walking distance and maternal satisfaction after caesarean section.

Sample size:

* The sample size is 128 women.
* The sample will include 64 mothers in the experimental group and 64 mothers in the control group.

Application time:

* Yoga nidra will be performed once in the sixth postoperative hour after caesarean section.
* Yoga nidra will be carried out once for each mother by the researcher Ayşegül Kılıçlı.
* The application will take 30 minutes.
* Only yoga nidra will not be applied to the control group. Other measurements and follow-ups will be carried out in parallel as in the experimental group.

Data collection tools:

* Introductory Information Form
* Visual Analogue Scale for Pain
* Patient Mobility Scale and Observer Mobility Scale
* Newcastle Satisfaction with Nursing Care Scale
* Note: Mobilisation distance will be measured with a metre.

Measurement time:

* Introductory Information Form will be filled out before application.
* Pain level will be measured immediately before the application.
* immediately after the application pain, mobilisation, first walking distance and maternal satisfaction will be measured.

Eligibility Criteria:
Inclusion Criteria:

* women who gave birth by caesarean section,
* whose birth was performed with spinal anaesthesia,
* who are 19 years of age or older and 35 years of age or younger,
* who were born at 37 or more weeks of gestation,
* who had a singleton birth,
* who do not have chronic diseases and any complications in this pregnancy and postpartum period,
* who have not performed yoga nidra practice before will be included in the study.

Exclusion Criteria:

* those who do not meet the inclusion criteria of the study,
* who do not voluntarily participate in the study,
* those who want to voluntarily leave the study at any stage after being included in the study,
* mothers who develop any health problems in the birth and postpartum period will be excluded.