cyrilzakka/clinical-trials huggingface dataset:
Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series

To demonstrate the functional results of patients with ankle fractures operated with arthroscopic deltoid repair.

Introduction: The diagnosis and treatment of ankle medial ligament lesions in malleolar fractures have always been surrounded by controversies. Even in the certainty of deltoid involvement and its consequent instability, the direct repair of this structure is not a consensus. In recent years, the arthroscopic technique to approach this ligament has been described with the objective of potentiating clinical results and minimizing possible complications.

Objective: To demonstrate the functional results of patients with ankle fractures operated with arthroscopic deltoid repair.

Methods: This is a retrospective study in patients diagnosed with ankle fractures associated with acute deltoid injuries and submitted to a malleolar fixation and deltoid arthroscopic repair between January 2018 and January 2020. All patients will fill an epidemiological questionnaire and will be evaluated for pain and function according to the Visual Analogue Scale (VAS) and the American Orthopaedic Foot and Ankle Society Score (AOFAS) at 12 months (6-24 months) average of follow-up.

Discussion: The inclusion of the deltoid complex and the low invasiveness of this technique can improve the clinical outcomes of these patients. Additional studies, with a prospective and comparative methodology are required to sustain this proposal.

Eligibility Criteria:
Inclusion Criteria:

- acute (less than two weeks) ankle fracture containing a medial ligament injury suspicion will be included. Syndesmotic lesion with a deltoid association will also be addressed

Exclusion Criteria:

* previous surgery
* autoimmune diseases
* neuropathy
* inflammatory diseases
* radiographic preoperative findings of ankle arthritis
* open medial wound
* coagulopathies
* any other condition that would contraindicate surgery
Effects of St. John's Wort on the Effectiveness of Oral Contraceptives

The purpose of this study is to evaluate the effects of a common herbal remedy, St. John's Wort, on the effectiveness of birth control pills. St. John's Wort has recently been shown to increase metabolism of some drugs. If it could increase metabolism of oral contraceptives as well, it may increase the risk of contraceptive failure and unintended pregnancy. Study participants will be evaluated for risk of ovulation on oral contraceptives before and during simultaneous therapy with St. John's Wort.

See Brief Summary

Eligibility Criteria:
Inclusion Criteria:

* Women taking or willing to take low dose oral contraceptives for 5 months
* No contraindications to hormonal contraception
Biofeedback and Osteopathic Procedures for Daytime Urinary Incontinence

The study will enroll 113 participants, randomly will be assigned to one of three groups will receive either group A will receive combined therapy of biofeedback training and osteopathy techniques, group B will receive biofeedback training, group C will receive osteopathy technique only over a period of 10 weeks, followed by an 8-week follow-up period. Outcome measures will include the 24-hour pad test, Pediatric Lower Urinary Tract Symptom Score (PLUTSS), and the bladder diary.

Children (male and female) with functional daytime urinary incontinence, typically the urge type, who were referred for physical therapy by a urologist were recruited from Mansoura Urology and Nephrology Hospital at Mansoura University. To participate in the study, participants had to be between 6 and 16 years old and have had functional daytime urinary incontinence for at least six months, with at least three episodes per week and a total of at least 60 ml of urine loss per week. Certain exclusion criteria were applied, including not having other types of urinary incontinence, neurological disorders, previous operations on the urinary or bowel system, current use of certain medications that could interfere with study results or pose a risk to the participant's health, severe cognitive impairment or dementia, recent participation in another clinical trial, active urinary tract infection (UTI), not having vascular disorders in the urinary system, and parental refusal to sign the written consent form.

Eligibility Criteria:
Inclusion Criteria:

* between 6 and 16 years old
* have functional daytime urinary incontinence for at least six months
* at least three episodes per week

Exclusion Criteria:

* neurological disorders,
* previous operations on the urinary or bowel system
* current use of certain medications that could interfere with study results
* pose a risk to the participant's health
* severe cognitive impairment or dementia
Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII

The purpose of this research study is to determine the effectiveness, safety, and pharmacokinetics (PK) of moroctocog alfa (AF-CC) in previously treated subjects, who are younger than 6 years of age, with severe or moderately severe hemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects, aged less than 6 years, with moderately severe to severe hemophilia A.
* A negative FVIII inhibitor titer at screening, and a medical history negative for a past FVIII inhibitor.
* At least 20 exposure days to any FVIII replacement product.
* Adequate hepatic and renal function
* CD4 count \> 400 cells/uL, and if receiving antiviral therapy must be on a stable regimen

Additional criteria for subjects participating in the PK assessment:

* Male subjects as described immediately above except they must have a FVIII Activity of less than or equal to 1% confirmed by the central laboratory screening test
* Age \< 6 years at time of PK assessment.
* The subject's size is sufficient to permit PK-related phlebotomy.
* The subject is able to comply with the procedures conducted during the PK assessment, including a mandatory 72-hour washout period preceding the PK assessment.

Exclusion Criteria:

* A history of FVIII inhibitor.
* Presence of a bleeding disorder in addition to hemophilia A.
* Treatment with any investigational drug or device within 30 days before the time of signing the informed consent form.
* Major or orthopedic surgery planned to occur during the course of the study.
* Regular (e.g., daily, every other day) use of antifibrinolytic agents or medications known to influence platelet function such as aspirin or certain nonsteroidal anti-inflammatory drugs (NSAIDs), or regular, concomitant therapy with immunomodulating drugs (e.g., intravenous immunoglobulin \[IVIG\], routine systemic corticosteroids).
* Known hypersensitivity to hamster protein.
Pediatric Neck Rescue Access Comparison

Two recent studies explored the emergency tracheotomy technique and the scalpel-bougie-tracheostomy technique as a neck rescue access for newborns and infants on a rabbit cadaver. Both studies lacked a key feature of real surgical access - bleeding during a true emergency. The study's objective was to comparatively assess the two techniques in a simulated environment with simulated bleeding and decreasing vital signs from the monitor like in real emergencies.

With ethical committee's approval the investigarors recruited for this cross-over trial pediatric anesthesiologists and intensivists. Emergency tracheotomy consists of four steps: vertical skin incision, strap muscles separation (2 Backhaus clamps), anterior luxation of the trachea with a 3rd clamp, and vertical puncture with tip-scissors of no more than 2 tracheal rings to insert the tube. The scalpel-bougie-tracheostomy involves separation of neck tissues to expose the trachea and tracheal incision both with a scalpel to insert the bougie to facilitate tracheal intubation. Participants were randomized to start either with emergency tracheotomy or scalpel-bougie-tracheostomy. They watched an instructional video and had four practicing attempts, followed by a fifth attempt which was assessed. Afterward, they crossed over to the other technique.

Eligibility Criteria:
Inclusion Criteria:

* board certified pediatric anesthesiologists or pediatric intensive care doctor
* informed consent signed

Exclusion Criteria:

* none
Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement

Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for synchronous bi-ventricular stimulation leads to improvement of hemodynamic parameters, physical capacity and quality of life. A continuous measurement of the left-ventricular volume would provide information about heart performance and could be used for both heart failure monitoring and optimization of CRT-therapy.


Eligibility Criteria:
Inclusion Criteria:

* De novo CRT-patients
* Planned implantation with a Lumax 740 HF-T device, a bipolar LV-lead and a true bipolar RV-lead
* NYHA class II or III
* QRS ≥ 150 ms
* LVEF between 15% and 35%
* LVEDD ≥ 55 mm
* Evaluable echo measurements

Exclusion Criteria:

* Persistent or permanent atrial fibrillation
* Heart surgery within the previous 3 months or planned for the time of study participation; post-heart transplantation or listed for heart transplantation
* Non-ambulatory patients
* Chronic renal dialysis
* Life expectancy less than 1 year due to a non-cardiac disease
* Age \< 18 years and/or limited contractual capability
* Addiction to alcohol, medical drugs or illegal drugs
* Pregnant or breast-feeding women
* Participation in another clinical trial
Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study

The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch™ Vaginal Cuff Closure System. This will be primarily done by measuring the frequency of implant passing following system use. Also assessed will be relevant safety and efficacy endpoints as compared to a two-to-one reference group (V-LOC barbed suture).

This is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip-stitch™ System in maintaining vaginal cuff closure following laparoscopic hysterectomy. Participating subjects will be randomized and evaluated for implant passing, successful cuff closure, healing, adverse events, dyspareunia, and pain. Blinded follow-up will involve in-person visits at one week, six weeks, and six months. There will be an additional unblinded follow-up by telephone at 12 months post operatively.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated Informed Consent Form 2. Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up 3. Female 18 years and older 5. Indicated for Laparoscopic Hysterectomy (may include TLH, LAVH, robotic assisted vaginal hysterectomy)

Exclusion Criteria:

1. History of HIV
2. History of Hepatitis C
3. History of diabetes, that in the opinion of the investigator may delay healing
4. Current use of systemic corticosteroids
5. Active infection of genitals, vagina, cervix, uterus or urinary tract
6. Active bacteremia, sepsis or other active systemic infection
7. Presence of Sexually Transmitted Infection (STI)
8. Evidence of pelvic inflammatory disease (PID)
9. Known clotting defects or bleeding disorders
10. Hemoglobin \< 8 g/dL
11. Metastatic disease
12. On anticoagulant therapy
13. Participation in another interventional trial
14. Pregnancy
15. Abnormal PAP results that have not been fully evaluated, or in the opinion of the investigator may indicate abnormal vaginal cuff healing
16. Co-morbidities that, in the opinion of the investigator, may indicate risk of abnormal vaginal cuff healing
17. Intra-op: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure

16. Intra-op: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure 17. Intra-op: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically 18. Intra-op: Cases requiring conversion to laparotomy prior to study intervention
Open-Label Extension of EryDex Study IEDAT-04-2022

This is an international, multi-center, prospective, open-label, non-comparative study to provide EryDex treatment to ataxia telangiectasia (A-T) patients who complete the IEDAT-04-2022 trial on the neurological effects of EryDex on subjects with ataxia telangiectasia (NEAT trial).

The IEDAT-05-2024 study aims to provide EryDex (dexamethasone sodium phosphate encapsulated into autologous erythrocytes) treatment to patients who complete the full study treatment period (including those receiving placebo) in the IEDAT-04-2022 (NEAT) study, who complete the study assessments, do not present safety contraindications to continuation of treatment, and provide informed consent. The open-label extension (OLE) treatment period will be 12 months. Participants will be considered to have completed the study when Visit 14 (Safety Follow-up) has been performed.

Eligibility Criteria:
Inclusion Criteria:

* body weight ≥15 kg
* participation in IEDAT-04-2022 study and its completion, including final efficacy and safety assessments

Exclusion Criteria:

* safety contraindications for continuation of treatment, as determined by the investigator
* clinically significant immune impairment that, in the opinion of the Investigator, precludes further treatment with corticosteroids
* Current neoplastic disease or previous neoplastic disease not in remission for at least 2 years.
* requiring treatment with a systemic corticosteroid
Discontinuation of Antidepressant Medication in Primary Care.

To investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and Mindfulness-Based Cognitive Therapy (MBCT) in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care.

Antidepressant use continues to rise, mainly explained by an increase in the proportion of patients receiving long term treatment. Although treatment guidelines recommend discontinuation after sustained remission, discontinuing antidepressants appears to be challenging for both patients and general practitioners. Mindfulness-Based Cognitive Therapy (MBCT) is an effective intervention that reduces the risk of relapse in recurrent depression and might facilitate discontinuation by teaching patients to cope with withdrawal symptoms and fear of relapse. The current study aims to investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and MBCT in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care.

Methods/Design This study involves a cluster-randomized controlled trial conducted in primary care patients with long-term use antidepressants with baseline and 6, 9 and 12 months follow-up assessments. Patients choosing to discontinue their medication will be offered a combination of supported protocolized discontinuation (SPD) and MBCT or SPD alone. Our primary outcome will be full discontinuation of antidepressant medication (= 0 mg) within 6 months after baseline assessment. Secondary outcome measures will be the severity of withdrawal symptoms, symptoms of depression and anxiety, psychological well-being, quality of life and medical and societal costs.

Eligibility Criteria:
Inclusion Criteria:

• Having received prescriptions for antidepressants in primary care for at least the past nine months

Exclusion Criteria:

* Current treatment by a psychiatrist
* Current diagnosis of substance use disorder
* Non-psychiatric indication for long-term antidepressant usage (i.e. neuropathic pain)
* Having participated in a mindfulness training (\> 3 sessions) within the last 5 years
* Inability to perform the assessments due to cognitive or language difficulties
* Younger than 18 years
Simulation-Based Training for Ultrasound-Guided Perineural Catheter Insertion

This study will determine the efficacy of a teaching program incorporating hybrid simulation in training practicing anesthesiologists on ultrasound (US)-guided continuous peripheral nerve block (CPNB).

This study will also examine the extent of practice change following participation in a regional anesthesia teaching program incorporating hybrid simulation. In addition, this study will assess remaining obstacles to incorporating the use of US-guided perineural catheters through identifying potential future interventions and "tool-kits" for setting up perineural catheter programs.

Study subjects will complete a pre-course survey to assess prior experience then participate in a standardized one-day workshop comprised of two sessions; 1) a didactic lecture and model scanning session and 2) a simulation session. Quantitative and qualitative assessments will be performed using video analysis by two blinded reviewers after equipment orientation (baseline), following first session, and following second session. Performance times, number of attempts, and composite scores for procedural performance and ergonomics will be analyzed within and between groups. Every 3 months for one year, subjects will be surveyed to assess implementation of PNB in practice and identify remaining barriers.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesiologists in practice ten years or more; active board certification (American Board of Anesthesiologists); active license to practice medicine in California; and willingness to spend one full day (8 hours) participating in the standardized workshop and undergo interval survey and interview follow-up for one year.

Exclusion Criteria:

* Formal training (e.g., post-graduate fellowship) in regional anesthesia; current practice includes the routine performance of US-guided PNB (≥10 blocks per month); or visual, hearing, or other communication impairment that would interfere with video recording or require substantial deviation from the standardized teaching curriculum.
A Study of RTA 402 in Obese Adults

To investigate changes in body weight and body composition in obese adults after repeated oral administration of RTA 402 once daily for 16 weeks, using placebo as a control.


Eligibility Criteria:
Inclusion Criteria:

* Written voluntary informed consent to participate in the study
* Male aged ≥ 20 and \< 50 years at the time of consent
* BMI ≥ 25.0 kg/m2 measured at screening
* Waist circumference (umbilical position) ≥ 85 cm measured at screening.
* MRI-measured visceral fat area ≥ 100 cm2 measured at screening

Exclusion Criteria:

* Subjects who have undergone weight control procedures (weight loss medicine, surgical therapy, exercise therapy, bariatric diet, etc.) at a medical institution within 3 months before the screening
* Subjects with conditions requiring treatment other than obesity
* History of cardiac failure (e.g., a prior diagnosis of congestive cardiac failure defined as NYHA class III or IV or a history of hospitalization for cardiac failure)
Effect of Vitamin D Supplementation on Health of Low Birth Weight Infants

The purpose of this study is to determine whether a weekly supplement of vitamin D to low birth weight term infants will reduce their mortality and hospital admissions and improve their immunity.

We are conducting a randomised controlled trial of weekly oral vitamin D supplements to low birth weight (\< 2.5 kg) term infants born in a large government hospital catering to a low-middle income population in Delhi. Mothers and infants are recruited at delivery and given weekly vitamin D supplements or placebo until 6 months of age. Data on infant morbidity, sun exposure and diet, with particular emphasis on breast milk and other milk intake, is collected by fieldworkers visiting the homes each fortnight. Mothers are encouraged to bring their infants to the hospital in case of any illness and at these visits the infant is seen by the project doctor who treats the infant and records additional morbidity data. At 6 months blood samples are being collected from a 20% random subsample of infants for measurement of 25OHD and indicators of immune activation. The primary outcome is mortality or incidence of any illness requiring admission to hospital.

Eligibility Criteria:
Inclusion Criteria:

* Born at term, as determined from last menstrual period
* Weighing \< 2.5 kg
* Resident within 12 km of the hospital and expected to continue living in the area for the following 6 months
* With no severe congenital abnormalities
* No morbidity severe enough to be expected to result in death before 7 days due to severe respiratory distress, shock, pulmonary sepsis, etc.
* Parental informed consent
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)

A prospective, multicenter, single-arm pivotal study will be performed with 192 subjects enrolled to have an inguinal or ventral robotic hernia repair procedure using the Medtronic Hugo™ RAS system. Subjects will be followed through two years. This study will be conducted using up to ten investigative sites in the United States (US).


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (age ≥ 22 years) as required by local law
* Subject has been indicated for one of the following hernia repairs: (a.) primary or incisional ventral hernia(s). Multiple small hernia defects are allowed with total distance of combined defects being \< 10cm (b.) inguinal (unilateral or bilateral) hernia(s).
* Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure
* The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form

Exclusion Criteria:

* Patients for which minimally invasive surgery is contraindicated as determined by the Investigator
* Patients with a recurrent hernia
* Subjects with femoral hernia defects
* Subjects with ventral hernia defect(s) located in M1, M5, or L4
* Patients with emergent hernia repair
* Ventral hernia is CDC (Center for Disease Control) grade 2 or higher
* Use of component separation techniques to close the hernia defect
* Inability to close the hernia defect
* Hernia defect is ≥ 10 cm
* Patient has BMI \> 40
* Patients with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
* Patients diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care
* Female patients pregnant at the time of the surgical procedure.
* Patients who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
* Patients who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
* Patients with active infections including but not limited to pneumonia, urinary tract infection, cellulitis, or bacteremia