cyrilzakka/clinical-trials huggingface dataset:
Dexmedetomidine and Laparoscopic Surgery

Conventionally General anaesthesia remains the choice for the majority of open abdominal surgical procedures, and regional anaesthesia is preferred only for patients who are at high risk under general anaesthesia . The main reason for selecting spinal anaesthesia as the first choice for laparoscopic cases was its advantages over general anaesthesia which include uniform total muscle relaxation, a conscious patient, economical, relatively uneventful recovery, pain free early postoperative period and the protection from potential complications of general anaesthesia. The main debatable point, however, seems to be the status of respiratory parameters among the two modes of anaesthesia during laparoscopic surgery. In this context it can be stated that spontaneous physiological respiration during spinal anaesthesia would always be better than an assisted respiration as in general anaesthesia.

The pneumo-peritoneum induced rise in intra-abdominal pressure including pressure on the diaphragm and carbon dioxide induced peritoneal irritation are the factors to be considered


Eligibility Criteria:
Inclusion Criteria:

* Elective gynaecological laparoscopic surgery
* Age 20-45 yrs
* Suspected surgery time 30 minutes
* Inflation pressure \<13 Cm H20

Exclusion Criteria:

* Contraindications to regional block (infection at the needle insertion site)
* Altered conscious level.
* Pregnancy
* Body mass index \>35
* Height \<155 cm
* Patients who have difficulty understanding the study protocol
Safety Study of Intranasal Oxytocin in Frontotemporal Dementia

Oxytocin is a hormone produced by the brain that appears to have important roles in social cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia were investigated. The results from the pilot study suggested that oxytocin may be associated with a modest improvement in neuropsychiatric behaviours seen in patients with Frontotemporal Dementia. To further examine the safety and tolerability of oxytocin in this disorder, the present study will examine the safety and tolerability of three different doses of intranasal oxytocin administered to patients with Frontotemporal Dementia twice daily for 1 week.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-80 years
* Meets "Neary criteria" for diagnosis of probable frontotemporal dementia
* Neuroimaging (CT, MRI or SPECT scan) supports diagnosis of frontotemporal dementia
* Provides written informed consent and has a caregiver or legally acceptable representative who provides written informed consent.

Exclusion Criteria:

* Has a history of a myocardial infarction within the last two years or congestive heart failure.
* Current uncontrolled hypertension
* Current bradycardia (rate \< 50 beats per minute/bpm) or tachycardia (rate \> 100 bpm)
* Current hyponatremia
* Current use of prostaglandin medications
* Females who are pregnant or breastfeeding
* Use of any investigational or experimental drug or device within the last 60 days prior to screening or within 5 half-lives of the experimental drug , whichever is longer.
Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness

TCC-PASTE is a randomised controlled trial comparing a simulation based training curriculum with standard training for ophthalmology residents learning to perform tunnel construction in manual small incision cataract surgery. After obtaining informed consent, participating trainees will be randomly assigned to learn to perform tunnel construction either through the simulation based curriculum or through the standard curriculum at their institute. Trainees assigned to simulation will learn through studying an eBook, participating in training sessions supported by repeated practice on a virtual reality simulator, and supervised training in live surgery to facilitate transfer of skill acquired in simulation to the operating room. To determine the effect of simulation based training, we will assess the number of errors trainees perform in the initial part of their intraoperative learning curve.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in a training program at a partner institute;
* No or minimal prior experience with MSICS (trainees within the first 2-3 months of matriculation, or having performed fewer than 20 procedures as the main surgeon but no more than 5 MSICS procedures within 6 months preceding participation in TCC-PASTE);
* Provide informed consent to participate in the study;
* Able to participate in routine patient care activities, as required by the partner institute, without the need to take overnight call for the duration corresponding to the simulation training phase.

Exclusion Criteria:

* Performed scleral tunnel construction as the main surgeon in 20 or more procedures;
* Prior experience with the HelpMeSee simulator or participation in the HelpMeSee simulation training curriculum.
* Required to take overnight call for the duration corresponding to simulation training phase.
Effect on Parkinson's Disease After Therapeutic Induction of CranioSacral Integrated Therapy

We are studying \& researching the effect of CranioSacral Integrative therapy on Parkinson's Diseased Patients for 3 months. With a therapeutic induction via manual CranioSacral integrative therapy for 90 minutes per session with a total of 2 session divided equally in a month (biweekly intervention). At the end of 3 months each patient will have total of 9 hours of CranioSacral Integrative therapy induced, we will document the symptoms and shortcomings of the patients at evaluation, before and after therapeutic treatment on a measured scale ranging from 1-10. Finally graphically and statistically measure the quality of change in the symptoms at the end of 3 months and provide executive summary of the research finding, which the investigators expect to be a positive one.

We are studying \& researching the effect of CranioSacral I therapy on Parkinson's Disease

Eligibility Criteria:
Inclusion Criteria:

* must be Diagnosed with Parkinson's Disease

Exclusion Criteria:

* Anyone without Parkinson's Disease
Onreltea (Brimonidine) Gel In Pediatric Patients With Capillary Malformations

Capillary Malformations (CM) affect a significant proportion of otherwise healthy children and may lead to psychological discomfort if left untreated. A significant proportion of untreated lesions undergo soft tissue thickening and darker discoloration later in life due to progressive ectasia of the affected vessels. While laser treatment is available, its use may be limited due to need for repeated sedation/general anesthetic use, partial response and cost.

The investigators propose to conduct an open-label, prospective, cohort study using Onreltea ( Brimonidine) gel for treatment of facial capillary malformations in children. The study medication will be applied topically on affected area of the skin daily for 12 weeks. Follow up visits will occur at at Week 1,4,8,12, and 16 to assess the efficacy and safety of the proposed treatment.

The study second aim is to explore the feasibility of conducting a multicenter placebo controlled study.

The investigators are planning to enroll in the study 20 participants at SickKids.

It is a prospective, open label, cohort study. Patients enrolled in the study will be followed at the Hospital For Sick Children for 16 weeks. They will come for the study visits 6 times: in 1 week, 4,8,12, and 16 weeks after the treatment has been started. During each study visit the study investigators will assess any changes in the characteristics of CM lesion(s) captured by a Chromometer \*, Analogue Scale and Erythema Assessment tools. Participants or their parents will assess the changes at the final study visit (VAS and EA tools).

Patients will be provided with study medication for all duration of the study treatment (12 weeks).

The results of the treatment will be compared with the baseline data to evaluate the efficacy and safety of Onreltea (Brimonidine) gel in children with facial capillary malformations.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of facial capillary malformation (port-wine stain, PWS) made by a dermatologist
* age: 12-17 years of age
* weight \> 45 kg
* lesions with a surface area \< 100 cm2
* signed consent and assent for study participation

Exclusion Criteria:

* skin breakdown overlying the malformation due to other dermatological conditions (e.g. eczema, psoriasis)
* current or treatment with laser the past 3 months
* other topical treatments used within the past 4 weeks (e.g. rapamycin, corticosteroids, calcineurin inhibitors, etc)
* known chronic renal or hepatic disorders
* known cardiovascular disorders
* other systemic medications that potentially interact with Brimonidine (opiates, chlorpromazine, methyphenidate, reserpine, etc)
* mixed capillary/ venous or lymphatic malformations
* known allergy to one of the constituents of Onreltea
* pregnancy, or sexually active subjects of child-bearing potential (CBP), unwilling to use contraception during the study (such as barrier method, or oral contraceptives).
Medium Term Outcome of Nonoperative Treatment After Achilles Tendon Rupture.

A total of 56 patients completed a previous study regarding non-operative treatment for acute achilles tendon rupture. This study consists of an additional follow up after 4-5 years depending on original date of injury.

30 patients suffering from acute Achilles tendon rupture was originally randomized to each arm, and followed up after 6 and 12 months. Of these a total of 56 patients was included in the final analysis, and invited to participate in this additional follow-up, 4-5 years after their original injury. Originally patients was monitored using: ATRS questionnaires, ATRA: Achilles Tendon Resting Angle, Heel Raise Work: number of lifts, lift height and total work, and tests of strength and stiffness in the ankle using a kinetic dynamometer.

Eligibility Criteria:
Inclusion Criteria:

* Suffered acute Achilles tendon rupture from April 2011 to March 2012, and then referred to Copenhagen University Hospital Hvidovre.
* Participated and completed the original study.
* The patient must be able to speak and understand Danish, as well as be capable to give informed consent to participating.

Exclusion Criteria:

* Terminal disease or serious illnesses with an ASA score of 3 or above.
* Any injury significantly influencing gate and function of the lower extremities other than re-rupture of the Achilles tendon.
MS Detection of Somatic Mutations in Hematological Malignancies

Detection of somatic mutations in hematological malignancies is now routinely assessed by NGS sequencing. This powerful approach is nevertheless time consuming and its costs represent limitation for its availability. An original approach is now available, using mass spectrometry (MS). In this study the analytical performance of both methods will be compared, using samples that were previously analyzed by NGS.

The goal of the study is to assess whether MS can represent or not a faster and cheaper way to detect key point mutations in patients suffering from hematological malignancies


Eligibility Criteria:
Inclusion Criteria:

* adults \>18 years old
* anonymized samples already studied with NGS in Strasbourg university hematology center for somatic mutations
* non-opposition of the patient for testing the archive sample with the new method

Exclusion Criteria:

* opposition for testing the archive sample with the new method
* insufficient archival material
* patient under protection
PENG Block vs Intrathecal Morphine in Total Hip Arthroplasty

To compare the impact of pericapsular nerve group (PENG) block to intrathecal morphine on postoperative analgesia, motor function and side effects in patients undergoing primary total hip arthroplasty under spinal anesthesia.

The study aims to confirm the non-inferiority of PENG block vs intrathecal morphine in patients undergoing total hip arthroplasty under spinal anesthesia. Non-inferiority will be assessed regarding maximum pain on a numerical rating scale at rest and during active hip flexion and regarding cumulative morphine consumption during 48 postoperative hours. Impact on quadriceps muscle motor function and side effects including pruritus, nausea and vomiting and hypotension will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with osteoarthritis of the hip scheduled for primary total hip arthroplasty under spinal anesthesia able to provide written informed consent

Exclusion Criteria:

* patient unwilling / unable to provide informed consent
* contraindications for any of the drugs and procedures included in the study protocol (allergies, local infection, coagulopathy)
* high risk for perioperative morbidity/mortality (ASA Physical Status Classification IV)
* preoperative use of strong opioid analgesia (due to hip pain or other acute/chronic pain condition)
* pregnancy
* substance abuse

Post Randomization Exclusion Criteria:

* change of surgical plan
* violation of study protocol
A Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin American population.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder.
* Inpatients with acute exacerbation of psychotic symptoms.
* Patients with a minimum score of 40 on the BPRS scale (1-7).

Exclusion Criteria:

* Concurrent treatment with antipsychotic agents at study drug initiation (within 12 hours prior to study drug initiation); for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and study drug initiation.
* Treatment with antidepressants or mood stabilizers within 7 days of start of ziprasidone.
* Patients currently receiving clozapine.
* Patients at immediate risk of committing harm to self or others.
A Study to Test the Design, Functionality, and Ergonomic Features of the Autoinjector

The main purpose of this study is to evaluate how well the autoinjector works in a group of people who are likely to use the autoinjector for injecting their medicine in the future. However, no active medicine is given by the autoinjector.

This device (called an autoinjector) automatically injects medicine under the skin with a sterile needle, and is similar to other types of autoinjectors currently being used for this purpose. This trial has been designed to make sure that people, who are likely to use this device, are able to self-inject and understand the training material. A total of 68 subjects took part in the study. About half (30 patients) will have either Rheumatoid Arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) and the other half will have psoriasis (a type of skin disease), since this device will be used by patients with one of these diseases to inject their medication. The study is designed to have each patient complete 2 self-injections with the autoinjector in 2 different sites-one in the front of the thigh and one in the abdomen 2 inches away from the navel. The order of the first injection location is decided by randomization. The patient will have an equal chance of having the thigh or the abdomen as the first injection. The study staff will assess the subject's safety prior to the patient leaving the clinic. Two prefilled, 1mL placebo autoinjectors for subcutaneous injection

Eligibility Criteria:
Inclusion Criteria:

* Have the capacity to understand and sign an informed consent form
* Have one of the following diagnoses: rheumatoid arthritis/psoriatic arthritis/ankylosing spondylitis, or psoriasis
* Be willing and able to self-inject

Exclusion Criteria:

* Have a recent history of (within 6 months prior to study entry) or current diagnosis of a major bleeding or coagulation disorder
* Have a prior history of a inability to use an autoinjector
* Have an allergy to latex or any component of the autoinjector
* Female participants who are pregnant
* Are unwilling to complete the study assessments
Comparisons of Clinical Outcomes Between Novel Tailored Transvaginal Mesh Surgery and Vaginal Native Tissue Repair Surgery for Pelvic Organ Prolapse

The issue of whether utilizing the mesh in the surgical treatment of pelvic organ prolapse remained undetermined.Thus, the aim of this study is to analyze clinical outcome of women who underwent pelvic organ prolapse surgeries with and without mesh implantation in the Department of Obstetrics \& Gynecology of National Taiwan University Hospital.

Hypothesis / aims of study:

The use of mesh for women with pelvic organ prolapsed (POP) remains under debate, despite a recent randomized trial reported a favourable anatomic outcome of transvaginal mesh (TVM) surgery for cystocele, compared with anterior colporrhaphy. Besides, the issue of preserving uterus or not in women with POP during operation is still undetermined. Thus, the aim of this study is to compare clinical outcomes of the novel tailored TVM surgeries and conventional transvaginal native tissue repair (NTR) surgeries for POP.

Study design, materials and methods:

Between November 2011 and September 2014, the medical records of all consecutive women who underwent POP surgeries in a medical centre were reviewed. The choice of surgery method was according to the surgeons' preference. Clinical characteristics and intraoperative data and postoperative clinical outcomes were recorded. Wilcoxon rank-sum test was used to compare the data between two groups. Kaplan-Meier survival analysis was used to compare the recurrence rate between two groups.

Eligibility Criteria:
Inclusion Criteria:

* All women who underwent surgical treatment of pelvic organ prolapse were enrolled in this study.
* ≥ 20 years old female.

Exclusion Criteria:

* Healthy women
* Without underwent surgical treatment of pelvic organ prolapse
Couple-Based Motivational Interviewing With Mobile Breathalyzers to Reduce Alcohol Use in South Africa

This project aims to develop and pilot test an intervention using couple-based motivational interviewing (MI) and mobile breathalyzers to reduce heavy alcohol use with couples living with HIV in South Africa.

This project aims to develop and test an alcohol intervention using couple-based motivational interviewing (MI) and mobile breathalyzers to build dyadic support around drinking in HIV-affected couples in South Africa. Specifically, the study aims to: 1) To develop a couple-based MI intervention with mobile breathalyzer technology to deliver real-time feedback on BAC levels. We will target heavy alcohol users with HIV and enroll their primary partner; 2) to develop and pilot test the study procedures for a future randomized controlled trial (RCT) of the couple-based intervention; and 3) to determine the feasibility and acceptability (F\&A) of couple-based MI as a standalone intervention and when combined with mobile breathalyzers to provide real-time feedback and support to couples. We will also conduct qualitative interviews with a subset of 15 couples to contextualize F\&A data and refine our procedures. Our goal is to demonstrate a proof-of-concept for the proposed intervention, which if shown to be feasible and acceptable, may provide a scalable intervention to reduce heavy alcohol consumption and improve HIV treatment outcomes for couples in South Africa.

Eligibility Criteria:
Inclusion Criteria:

* in a primary relationship for at least 6 months
* aged 18-49
* have at least one partner (the "index patient") with a positive AUDIT-C screen score
* has been on antiretroviral therapy (ART) for at least 6 months
* has disclosed HIV status to their partner

Exclusion Criteria:

* Report severe intimate partner violence in the past 3 months and/or fear that their safety would be at risk (reported during screening)
Digital Supportive Care Awareness & Navigation

To pilot test the feasibility, usability, and preliminary efficacy of the D-SCAN mobile application in cancer patients and caregivers at Duke.

D-SCAN, a digital patient navigator service in the form of a mobile application ("app"), has been designed at Duke, with feedback from Duke Cancer Institute (DCI) patients, caregivers and clinicians (screenshots in Appendix A).3 Its purpose is to facilitate awareness of available Cancer Patient Support Program (CPSP) services at Duke, and to also help patients recognize their unmet symptom management needs by answering questions from the Edmonton Symptom Assessment Scale (ESAS). This novel electronic system helps to connect patients and their loved ones with existing resources tailored to their unique situations, ensuring that no supportive care needs go unaddressed, thus improving patients' lives and their cancer care.

This protocol aims to assess the feasibility, usability, and preliminary efficacy of the D-SCAN mobile application. The app data, along with quantitative and qualitative feedback obtained during the pilot, will inform future development and design of a subsequent efficacy trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least age 18
* Patients who have the capacity to give consent
* Patients with advanced cancer who have initiated treatment at the DCI in the last 12 weeks
* Caregivers over the age of 18 caring for either enrolled or not enrolled patients with advanced cancer who have initiated treatment at the DCI in the last 12 weeks

Exclusion Criteria:

* Patients who are too ill to participate (per clinician discretion)
* Patients not able to read or understand English
Multimedia Program to Promote Positive Bus Behavior

This project evaluated a multimedia student behavior management program for school bus drivers and school administrators.

We developed a comprehensive multimedia training program for transportation departments. In the Driver's Seat: A Roadmap to Managing Student Behavior on the Bus guides transportation departments in creating and maintaining a safe, responsible, and positive environment on the bus through drivers' use of effective student behavior management techniques. The program teaches skills for the bus context based on the principles of positive behavior supports and the foundational work of Sprick and colleagues (Sprick, 1990; Sprick, Garrison, \& Howard, 2002; Sprick, Sprick, \& Garrison, 1992). In the Driver's Seat was designed as a stand-alone DVD-based training program for school bus drivers of elementary schools, using video examples presenting real driver and student interactions on the bus. A computer-based program for transportation supervisors supplemented the driver training materials and included information for supervisors about developing and maintaining department-wide transportation policies, as well as an overview of the bus driver training materials and instructions for their use.

The components of the In the Driver's Seat bus driver training program could be implemented by a transportation team without the need of an expert and could be used to train new personnel or review and refresh veteran personnel's skills. The DVD-based component was designed for use by a transportation supervisor or driver trainer in a group setting with drivers and augmented the material presented in the drivers' program.

Eligibility Criteria:
Inclusion Criteria:

* Bus drivers and administrators will be 18 or older.
* All subjects must be employed by elementary or middle schools.

Exclusion Criteria:

* Excluded from the study will be bus drivers and administrators not in elementary schools
* Staff who are not bus drivers or administrators for elementary or middle schools will also be excluded.