cyrilzakka/clinical-trials huggingface dataset:
A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes

The goal of this randomized clinical trial is to assess the outcomes of total laparoscopic hysterectomy vs subtotal laparoscopic hysterectomy + mini-laparotomy for uterine extraction for benign gynecological conditions in terms of change in quality of life at 36 months after surgery and patient's impression of improvement. The secondary objectives of the study are to assess any differences in terms of peri and postoperative outcomes (postoperative pain, blood loss, hospital stay, intraoperative or short and long-term postoperative complications, long term urinary, bowel and pelvic floor symptoms, prevalence of vaginal cuff dehiscence).

Participants will fill the following questionnaires pre-operatively and at the follow up:

* Short Form 36 (SF36),
* Euro Quality of life 5D-3L (EQ 5D-3L)
* Female Sexual Function Index (FSFI)
* Patient Global Impression of Improvement (PGI-I) only during the follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Signed informed consent

Exclusion Criteria:

* Uterine or adnexal pathology suspect for malignancy
* Abnormal or unknown PAP test
* Patients with invasive neoplasia in the previous 5 years (excluding non-melanoma skin tumors, breast cancer T1 N0 M0 Grade 1 or 2 without signs of recurrence or activity).
* Previous radical pelvic surgery or radiotherapy;
* Age \> 80 years
* Pregnant patients
* Desire for further pregnancies
* Contraindications to general anaesthesia or to the Trendelenburg position
* Refusal to sign informed consent
Parietex Progrip Study

The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.

* Patients in ProGrip group will be treated with self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
* Patients in Lichtenstein group will be treated with lightweight Polypropylene meshes requiring fixation by sutures.
* Study participation will start at signature of informed consent and each patient will be assessed before surgery. A close follow-up will be performed: 7 days (questionnaires and phone call), 1 month (clinical visit), 3 months (questionnaires and phone call), and final evaluation at 12 months (clinical visit) after surgery, which will end the participation to the study.
* 600 adult males divided in 2 groups requiring primary uncomplicated elective inguinal hernia mesh repair will be included in the study. Patients will be stratified by center.

Eligibility Criteria:
Inclusion Criteria:

* All male patients at participating centers with a primary, uncomplicated inguinal hernia.
* Collar of the defect ≤ 4 cm
* Signed informed consent

Exclusion Criteria:

* 30 years ≥ Age ≥ 75 years
* Emergency procedure
* Inclusion in other trials
* Bilateral inguinal hernia
* Recurrence
A Feasibility Study Designed to Assess the Efficacy of the ActiLady Device in Adult Female Subjects With Dysmenorrhea

ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain associated with menstruation (clinically known as dysmenorrhea).


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18-35 years
2. Regular menstrual cycles (26-35 days); average duration of menstruation ≥5 days for the 4 months preceding the beginning of the trial.
3. Dysmenorrhea pain score \>50mm on a 100mm visual analog scale (VAS) for the maximum abdominal pain
4. Analgesic use during every menstrual cycle
5. Non-pregnant, with no intentions to get pregnant during the clinical trial
6. Agrees not to use oral contraceptives or an intrauterine device (IUD) during the trial period
7. Agrees not to use analgesics, except during permitted period (16:00-04:00 the next day, daily)
8. Consents to the use of pads or other vaginal devices throughout the trial period
9. Subject is able to comply with all the requirements of the study and agrees to participate in all the activities of the study
10. Signed written informed consent form (ICF) to participate in the study

Exclusion Criteria:

1. Pregnant or lactating women
2. Used hormonal and/or oral contraceptives in the preceding 4 months
3. Use of an IUD in the preceding 4 months
4. Previous diagnosis of secondary dysmenorrhea
5. Urinary incontinence
6. Duration of menstruation is \<5 days
7. Subjects with a known sensitivity to mechanical vibrations and/or silicone
8. Participation in current or recent clinical trial within 30 days prior to baseline visit
HFNO Reduces Hypoxia During Sedated Gastroscopy or Colonoscopy in High Risk Patients

The objective of this study is to observe the preventive effects of high flow nasal oxygenation on the incidence of hypoxia during gastroscopy or colonoscopy sedated with propofol in high-risk patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ranging from 18 to 80, both sexes
2. Patients receiving selective gastroscopy or colonoscopy or gastroscopy and colonoscopy procedure
3. ASA Ⅲ\~Ⅳ
4. 18 kg/m2\<BMI\<28kg/m2
5. The anticipated operation time of the procedure shall be less than 30min.
6. Patients should clearly understand and voluntarily participate in the study, with signed informed consent.

Exclusion Criteria:

1. Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc. who can not tolerate high-flow nasal cannula.
2. Patients diagnosed POCD
3. Patients clearly identified difficult airway
4. Patients with mechanical ventilation
5. Patients with acute respiratory infection and asthma
6. Patients with acute upper gastrointestinal hemorrhage accompanied by shock, severe anemia, gastrointestinal obstruction accompanied by retention of gastric contents
7. Patients with aortic stenosis and carotid stenosis
8. Patients allergic to sedatives such as propofol
9. Patients without civil capacity such as cognitive dysfunction
Brain-Based Biomarkers in Response to TMS in MDD

The overarching goal of this research program is to elucidate causal and directional neural network- level abnormalities in depression, and how they are modulated by an individually-tailored, circuit-directed intervention. By using concurrent TMS and EEG, the investigators can overcome a major limitation of EEG - the inability to demonstrate causality. Here, we plan to recruit patients with medication-resistant depression undergoing rTMS treatment. At multiple time points, we will perform TMS-EEG to investigate the excitability and connectivity profiles of brain networks and how they are modulated during treatment. This study aims to provide objective brain network measures that can predict and track clinical response to TMS treatment. Findings from this study will be utilized to develop a novel, personalized treatment protocol based on individual brain networks.

Goals of the study are as follows:

* To evaluate the ability to predict and track brain network changes during TMS treatment for medication-resistant depression.
* To develop quantitative tools that measure the connectivity and excitability of the brain using resting and single pulse TMS-EEG.
* To determine the feasibility of recording EEG biomarkers in the clinic without disrupting clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18 to 60
* Medication-resistant depression as assessed by psychiatrist
* Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
* Has failed \>1 previous adequate antidepressant medication trials
* Right-handed
* No current or history of neurological disorders
* No seizure disorder or risk of seizures
* No use of PRN medication within 48 hours of the scheduled study appointment

Exclusion Criteria:

* Any unstable medical condition, any significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc
* Current electroconvulsive therapy (ECT) or prior treatment failure with ECT
* Currently pregnant or breastfeeding
Shoulder Kinematics and Acute Ultrasonographic Changes in Manual Wheelchair Users With Spinal Cord Injury

People who lose function of the lower limb due to spinal cord injury (SCI) need to use their arms for activities of daily life especially during weight-bearing tasks, such as transfers, and manual wheelchair (MWC) propulsion in order to maintain mobility. Persistent use of the upper limbs constitutes biomechanical difficulties, especially in the shoulder joint. The most commonly affected area in the shoulder is supraspinatus and biceps tendon. Four different stoke patterns have been classified in MWC users. Distinct amounts of force may be applied to the shoulder joint during propulsion with different stroke patterns and this can affect the shoulder tendons in different rates. In this study, investigators aimed to evaluate and compare the acute sonographic changes in supraspinatus and biceps tendons after a wheelchair propelling test in MWC users with SCI with different stroke patterns. Also, it is intended to determine the risk factors related to the stroke patterns that may be associated with these sonographic changes.

Fourty male MWC users with SCI were will be divided into 4 groups according to their stroke patterns (arcing, semicirculer, single loop, and double loop). Participants will use their own wheelchairs with their preferred stroke pattern for 20 minutes at a speed of 1 m / s on a motorized treadmill for a wheelchair propelling test. Wheelchair propelling videos will be recorded during the test. Shoulder kinematics will be analyzed using Kinovea motion analysis software and stoke pattern will be confirmed. Ultrasonographic assesment of participants' nondominant shoulder will be performed before and after testing procedure.

Eligibility Criteria:
Inclusion Criteria:

* People with traumatic spinal cord injury
* Age between 18 to 65 years,
* Neurologic injury level at T2 or below, with AIS grade A or B,
* Time since injury at least 6 months,
* Using manual wheelchair as their primary mobility tools

Exclusion Criteria:

* Fractures in nondominant upper limb at any time,
* Shoulder surgery within the past 5 years or corticosteroid injections within the past 3 months to the nondominant shoulder,
* Upper limb pain that restricts propulsion of a manual wheelchair,
* A history of cardiopulmonary problems and degenerative joint diseases
TVT Versus TOT in Urinary Stress Incontinence With No Intrinsic Sphincter Deficiency

The aim of this study is to compare trans-vaginal tape(TVT) and trans-obturator tape(TOT) procedure in female urinary stress incontinence with no intrinsic sphincter deficiency.

Patients with isolated stress incontinence attending to Dr Zekai Tahir Burak Woman Health Teaching and Research Hospital Urogynecology Department will be prospectively randomized,by a computer generated randomisation code,to the TVT or TOT. The patients will be aware of the type of the surgical procedure before the operation.

Preoperative evaluation includes clinical history,urinanalysis,pelvic examination QoL assessment and urodynamic study. QoL included Urogenital Distress Inventory Short Form (UDI-6) and the Incontinence Impact Questionnaire Short Form( IIQ-7).Urodynamic study includes cystometry,urethral profilometry and Valsalva leak point pressure (VLPP).In all patients,pelvic floor defect will be evaluated according to the POP quantification (POPQ) staging.To diagnose the occult stress incontinence in patients with pelvic prolapse, a cough test after reducing the prolapse will be performed.Patients will be followed up at 6 and 12 months postoperatively.Objective cure is defined as a negative cough stress test .Negative cough stress test ,but occasional urine leakage during stress will be considered ''improved''.

Postoperative subjective outcomes will be categorized as follows:cured (UDI-6 and IIQ-7 postoperative\<10), improved (UDI-6 and IIQ-7 if postoperative\>preoperative) and worsened (UDI-6 and IIQ-7 if postoperative\<preoperative).

Eligibility Criteria:
Inclusion Criteria:

* Women with urinary stress incontinence with no intrinsic sphincter deficiency
* Women with or without pelvic organ prolapse

Exclusion Criteria:

* Previous incontinence surgery
* Urge incontinence or overactive bladder
* Mixed incontinence
* Intrinsic sphincter deficiency
* Body mass index\>35
* Un-willing for randomisation
Laryngeal Mask Ambu Aura Once vs. Supreme in Children

The purpose of this study is determine safety and efficiency of mechanical ventilation in children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA Supreme). The main interest is leakage pressure of oropharynx and stomach. The null hypothesis is that leakage pressures of Ambu AuraOnce and LMA Supreme are equivalent. The alternative hypothesis is that there is a difference in leakage pressure.

Before starting surgery patients will be anesthetised and airway managed either with LMA Ambu AuraOnce or Supreme. Ventilation parameters, stomach inflation, and hemodynamic parameters will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1-10 years
* ASA I - III
* Elective procedure in general anaesthesia
* Parental informed consent

Exclusion Criteria:

* Non fasting patient
* Body mass index \> 35 kg/m2
* Cervical spine pathologies or peripheral neurologic deficiences
* Malformations of upper airway or head
* Anamnestic hiatus hernia or esophageal reflux
* Status post operation of stomach or esophagus
* Recurrent respiratory infection or obstructive airway disease
* Non elective procedure
SELECT-LIFE: A Research Study Looking at Long-term Effects of Semaglutide in People Who Took Part in the SELECT Cardiovascular Outcomes Trial

Participants are being asked to participate in SELECT-LIFE study because participants take part in the SELECT trial.

SELECT-LIFE study is a survey-based study that will start when the SELECT trial ends.

SELECT-LIFE looks at the long-term effects of participants taking part in the SELECT trial including the trial medicine participants have been taking.

When the SELECT trial ends, participants will no longer get the medicine participants got in the study, even if participants decide to take part in the SELECT-LIFE study.

Participants will not get any specific treatment or medicine as part of the SELECT-LIFE study, and participants will be treated as participants normally would by their own doctor.

The SELECT-LIFE study will last for up to 10 years after SELECT trial ends, and participants will be asked to fill in a questionnaire about their health every 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Randomized into the SELECT clinical trial (EX9536-4388) and has not withdrawn consent, regardless of level of participation, dose achieved or treatment discontinuation.
* Signed SELECT-LIFE consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

Exclusion criteria:

* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Live Instruction and Fitness Tracking*: A 12-week Combined Aerobic and Resistance Training Intervention

This project was a 12-week aerobic and resistance training intervention that included participants meeting at a pre-determined location from 1-2 times per week for 12 weeks. Aerobic activity was walking. Resistance training included traditional and non-traditional implements.

The 12-week program included a 60-minute session. Participants filled out a Physical Activity Readiness Questionnaire and completed pre-exercise fitness tests. The fitness tests included the curl up, pushup, and a 1.5 mile walk test. The session involved a warmup which included stretching followed by a 5-min walk for a total of 10 minutes. Functional bodyweight and resistance training exercises were implemented and supervised by the principal investigator (PI) who specializes in program design and implementation. The exercises targets major muscle groups such as legs, chest, back, and shoulders. The resistance training portion took 30-35 minutes. Steady-state aerobic activity which included walking took place at the end of the session for 10-15 minutes. The intensity was monitored using self-rated RPE scores which participants would report to the PI following each session.

Eligibility Criteria:
Inclusion Criteria:

* Somerset county resident
* Pass American College of Sports Medicine (ACSM) screening algorithm 2022 and the Physical activity readiness questionnaire

Exclusion Criteria:

* signs/symptoms of cardiovascular, metabolic or renal disease without medical clearance
Prevalence of COVID-19 Infection Among HCW in a French University Hospital

The objective of this study is to determine the prevalence of SARS-Cov2 infection among health care workers exposed of Lille University Hospital, to describe its evolution during the epidemic taking into account the influence of occupational and environmental exposure determinants.


Eligibility Criteria:
Inclusion Criteria:

- Health Care workers with or without symptoms suggestive of a COVID-19 infection

Exclusion Criteria:

* HCW working off-site at the CHU de Lille
* HCW on sick leave.
* HCW outside the Lille University Hospital temporarily coming as reinforcements in the context of the epidemic.
Continuous Ambulatory Peritoneal Dialysis With Telemedicine

This clinical trial is an open-label, prospective, single-arm, single center study.

In this study is planned to involve 12 patients, who need continuous ambulatory peritonealis dialysis (CAPD). Telemedicine software is related to peritoneal dialysis. With the help of a tablet device running an Android system on patients and the care team and the smart devices attached to it (scales, blood pressure monitor), patients perform measurements in their homes in connection with solution changes. The resulting data is transmitted through the telemedicine system to the care team, which can take immediate intervention if necessary and notify the patient of any change in therapy.

After enrollment, the patient is educated about the using of telemedicine system and then the standard CAPD will be continued in their home treatment supplemented with a telemedicine system.

There is a monthly follow-up visit in the CAPD therapy. Before each control visit a telemedicine doctor, for whom are available telemedicine data, decides whether a control visit is necessary. After that line the patient will be subjected to a personal check - up visit by another specialist, for whom the result of the telemedicine visit is unknown. At the end of the control visit, the doctor declares whether it could have been triggered the examination with the review of telemedicine data.

In the end of the study will be summarized the average number of visits that can be omitted and will be analyzed the extent to which the two medical opinions and the necessity of the visit matched.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years;
* Signed Informed consent form;
* Patients treated with CAPD;
* The subject communicates well with the investigator and is able to help understand and adhere to the requirements of the study plan.

Exclusion Criteria:

* The consent was withdrawn by the volunteers at any time after the information and the signed informed consent form;
* Poor general condition;
* Any disease which, in the opinion of the investigator, endangers the health of the volunteer and / or contraindicates the conduct of the study.
Acupressure for Fatigue and Low Back Pain

The purpose of this study is to compare two kinds of self-administered acupressure (relaxation acupressure and stimulating acupressure) to usual care for management of fatigue and pain in low back pain patients.

Hypothesis: Self-administered relaxation acupressure will result in improvements in fatigue and sleep quality, pain, and physical function compared to stimulating acupressure and usual care.

Acupressure is a Traditional Chinese Medicine (TCM) technique based on a philosophy similar to that of acupuncture. It involves the application of physical pressure on different acupuncture points (acupoints). One advantage of acupressure is the ability to self-administer the treatment. Acupressure is also a viable alternative to acupuncture in situations where patients: (1) cannot come to the clinic to receive an acupuncture treatment; (2) when a more frequent intervention is needed; or (3) where needle phobia or safety concerns are an issue.

The objective of this study is to evaluate the validity and feasibility of teaching acupressure interventions using an acupressure educator for the management of symptoms related to low back pain.

Specific aims:

1. To examine the effect of 6-weeks of relaxation acupressure (RA) compared to a regime of stimulating acupressure (SA) or wait-list control (WL) on fatigue and sleep quality as assessed by Brief Fatigue Inventory and wrist-worn accelerometry (sleep efficiency).
2. To explore the effect of 6-weeks of RA compared to a regime of SA or WL on for chronic low back pain in terms of reduced pain and improved function.

Eligibility Criteria:
Inclusion Criteria:

* Aged18-65 years
* Non-specific low back pain (either by self-report or via ICD-9 codes 724.2, 724.5, 846.0-846.9)
* Low back pain that has persisted for at least 3 months
* Minimum of 3/10 on the Pain Bothersome Scale
* Minimum of 3/10 fatigue severity
* Ambulatory with or without assistive device
* Ability to operate the accelerometer (Actiwatch-S)
* Stable medication regiment for the previous 2 months
* Report of a physician's visit during the previous 24 months
* English-speaking

Exclusion Criteria:

* Medically unstable (acute conditions or acute presentations of chronic conditions)
* Current pregnancy
* Radiculopathy or report of low back pain radiating to below the knee
* Reported history of spinal fracture, herniated lumbar disc, ankylosing spondylitis, and spinal stenosis.
* Report of back surgery within the preceding 12 months
* Participation in active litigation or compensation claims
* Conditions that might confound treatment effects or interpretation of results (for example, rheumatoid arthritis, lupus)
* Acupuncture or acupressure within the preceding 12 months
* Report of sleep apnea
* 2nd or 3rd shift workers or other non-traditional sleep schedules
* Use of anti-coagulant/platelet therapy within the preceding month
Physical Activity Effects on Health Care Utilization

To determine the magnitude of the relationship between physical activity level and subsequent health care utilization over a seven to ten week period in a general population.

BACKGROUND:

In recent years, the benefits of a physically active lifestyle have been well established with respect to chronic health problems such as coronary heart disease, hypertension, obesity and osteoporosis. However, the extent to which physical activity influences health care utilization is less clear. If physical activity levels are inversely associated with utilization patterns, then policies encouraging exercise may produce short-term reduction in health care costs.

DESIGN NARRATIVE:

A multivariate regression analysis was conducted for a representative sample of more than 600 adults who participated in a longitudinal field trial of health risk appraisal instruments. Using the Harvard Alumni Activity Survey as the physical activity measure, the analysis controlled for a variety of predisposing, enabling, and need characteristics that also influenced utilization behavior.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria