cyrilzakka/clinical-trials huggingface dataset:
The Significance of the Mesh Thickness in the Operation of Inguinal Hernia

The trial compares the postoperative complain, pain, quality of life after the implantation of a heavy-weight alternative light-weight mesh, by randomly allocating patients with inguinal hernia disease to two groups of surgeons, each group being trained to operate with one of the above mentioned meshes.

Hypothesis: There is less postoperative pain after the implantation of a light-weight mesh.

The implantation of mesh in the operation of inguinal hernia has resulted in a continuously diminishing frequency of reoperations. Randomized controlled trials indicate that hernia repair with an open mesh technique has a shorter learning curve, is cheaper and may give less recurrences than laparoscopic hernia repair in general surgical practice. Furthermore, local anesthesia has significant advantages for both the patient and the health related economy compared to general anesthesia and regional anesthesia. The experience of the last decade within the field of groin hernia surgery has focused interest on quality of life and postoperative pain (especially chronic pain). Chronic pain is defined as pain that remains 3 months after the operation. Recent studies indicate that one third of all patients operated on for inguinal hernia have some degree of chronic pain and that 4-6 % of patients have pain interfering with daily activities one year after surgery.

In the present study a heavy-weight polypropylene mesh will be compared with a light-weight partly absorbable mesh. In an expertise-based randomized control trial patients will be randomly allocated to two groups of surgeons, each group well trained to use one of the two meshes.

Eligibility Criteria:
Inclusion Criteria:

* Male, age 25 years or older
* Reducible, unilateral, inguinal hernia (not femoral hernia) that has not been operated on before

Exclusion Criteria:

* The patient is not able or do not want to give written informed consent
* The patient is not suitable for an operation in local anesthesia
* Anticoagulant medication or a known coagulation disorder
Lower Uterine Segment Following a Cesarean Section With Barbed Suture

This aim of this study is to investigate the LUS in the pregnancy following a previous cesarean section with the use of barbed or conventional smooth suture.

To better assess the risk of uterine rupture, some authors have proposed sonographic measurement of lower uterine segment (LUS) thickness near term, assuming that there is an inverse correlation between LUS thickness and the risk of uterine scar defect. Recently, barbed suture has been employed for closing uterine wall after cesarean section, demonstrating the reduction of closure time of the uterine incision and estimated blood loss. Until now, the impact of barbed suture in future pregnancies has not been investigated.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* being undergone a previous elective cesarean section at term of pregnancy (more than 37 weeks of gestation), in which barbed or conventional smooth suture was used for closing anterior uterine wall

Exclusion Criteria:

* having done more than one cesarean section
* having done a previous urgent cesarean section
* having done previous uterine surgical procedures with exception than one cesarean section
Motor Learning for Upper Limb Hemiparesis After Stroke

The purpose of this research is to learn about practice conditions that may benefit stroke survivors when learning to use their more affected arm to perform a task. Participants will be randomized into two groups. Experimental and control groups will differ by one practice variable that will not be disclosed until completion of testing procedures. Participants will practice a motor task using both their more and less affected arms for two consecutive days. A Pre-Test will be administered on Day 1 before the training begins. Immediate Transfer of Learning will be administered on Day 2 after the completion of training. Delayed (24-hour) Retention and Transfer Tests will be administered on Day 3.

Stroke involves loss of blood flow to the brain and can cause impaired upper limb motor function, resulting in long term disability. Targeted motor learning interventions can improve skill acquisition and functional upper limb use after stroke. For example, repetitive practice of a motor task has been shown to improve motor learning outcomes. However, more research is currently needed to identify important active ingredients in complex motor learning interventions and determine the most effective approaches for improving upper limb recovery after stroke. The purpose of this study is to investigate the impact of a specific practice variable on motor learning for individuals with upper limb hemiparesis after stroke. This research will inform the development of future stroke rehabilitation interventions aimed at improving skill acquisition and motor learning.

Eligibility Criteria:
Inclusion Criteria:

* At least 6 months following stroke (ischemic or hemorrhagic)
* Upper limb weakness resulting from the stroke
* Able to follow 2-step commands
* Box and Block test score of 3-60
* Intact proprioception at the index finger of the weaker arm
* English speaking

Exclusion Criteria:

* Severe neglect (Score of 2 on extinction and inattention items of NIHSS)
* Arm pain that limits movement or loss of functional range of movement (contracture)
* Unable to give informed consent
* Received Botox within the past 3-months
Isoenergetic High Intensity Interval Training and Moderate Intensity Training in Adults With Type I Diabetes

Type 1 diabetes (T1D) is associated with increased risk of poor cardiometabolic health. Regular exercise is recommended for optimal management of comorbidities in T1D. Unique barriers to exercise exist for T1D, including fear of hypoglycemia, unpredictable glycemic excursions with exercise, and inadequate knowledge about exercise. Unlike traditional moderate intensity continuous training (MICT) which requires extended periods of time, high intensity interval training (HIIT) requires minimal time (\~10 minutes of exercise per session), with the potential to rapidly stimulate mitochondrial biogenesis and metabolism. The extent to which these exercise strategies alter metabolomic signatures of carbohydrate, fat, and amino acid metabolism in T1D is unknown. The overall goal of the proposed project is to identify the acute metabolic effects and physiological modifiers of HIIT compared to MICT and control (CON) using metabolomic profiling and cardiometabolic assessments in 14 adults with T1D. Using a randomized cross-over approach, the primary aim is to compare the metabolomics response immediately post, 1 hr post, and glycemic control through 48 hrs after HIIT, compared to MICT matched for total energy expenditure, versus a no exercise CON. An additional aim will be to characterize the influence of biological sex and physiological outcomes (i.e. body composition, lean mass, visceral fat) on the metabolomics profile of these subjects. Outcomes from the present study, with existing data from our team, will lay the foundation for a larger diet and exercise lifestyle intervention that will ultimately lead to changes in clinical practice to co-manage glycemia and cardiometabolic comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of presumed autoimmune T1D, receiving daily insulin
* Last hemoglobin A1c \<9%
* 18-51 years
* Duration of T1D: ≥ 1 year
* Body mass index (BMI) \<30 kg/m\^2
* Generally healthy, with no conditions that could influence the outcome of the trial, and in the judgement of the investigators is a good candidate for the study, based on a review of health history

Exclusion Criteria:

* Physician diagnosis of active diabetic retinopathy that could be worsened by exercise
* Physician diagnosis of peripheral neuropathy with insensate feet
* Physician diagnosis of autonomic neuropathy
* Medications: beta-blockers, agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives; any hypoglycemic agent other than insulin.
* Severe hypoglycemic event defined as the individual requiring a third party of hospitalization in the last 6 months
* Diabetic ketoacidosis in the last 6 months
* Has a closed-loop pump and not willing to use manual mode
* Physician diagnosis of cardiovascular disease that would affect exercise tolerance
* Currently doing HIIT
* Severely impaired hearing or speech
* Pregnancy
Super-Supporters - Virtual Care Technology Navigators

The Super-Supporter Program is designed to provide pre-visit support to patients who are at risk of not being able to participate in Virtual Care modalities (specifically, Clinical Video Visits). Patient technology navigators (Super-Supporters) will reach out before video visits and help the patient connect more easily and successfully with their providers in Virtual Care appointments.

The Super Supporter Technology Navigator Program was designed to support patients, across the health system, to connect more easily and successfully with their providers in Virtual Care appointments. Super Supporters call patients in advance of Virtual Care appointments to remind them of their appointment, ensure that they have a device on which to conduct the appointment, set up the device for a successful Virtual Care appointment, help them set up and log into their patient portal account, and practice connecting with their provider using a practice virtual video visit. This research study is designed to determine differences in connection rate, patient reported health, patient access and responses to a healthcare climate questionnaire by comparing those helped by a Super Supporter and those supported by an Enhanced Usual Care program.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a video visit with a provider at Atrium Health (all locations)
* Identified as at risk of a failed video visit using criteria (1) a failed prior video visit (a discrete data field noting a prior visit was unsuccessful or converted to telephone-only visit), or 2) no prior access to the Electronic Health Record-connected patient portal

Exclusion Criteria:

* Patient plans to change visit to in-person or telephone only
* Patient declines assistance from the Super-Supporter program.
The Effect of Nicotine Delivery Rate on Reinforcement

The dose-effect curve to estimate a threshold delivery rate for reinforcement. The project addresses the FDA Center for Tobacco Products (CTP) interest #1: Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation and relapse). IV nicotine, in contrast to ECs, can deliver precise, reproducible dosing, which is necessary for accurately assessing dose-response and threshold effects. The estimated threshold for reinforcement will establish a benchmark for evaluating the addictive potential of ECs and other inhaled nicotine products.

A placebo-controlled study that will recruit male and female nicotine dependent smokers/EC users (n=18) to complete four separate experimental sessions. Each session will include one randomly assigned infusion that will be either saline or a single dose of nicotine (1 mg per 70 kg body weight) delivered at three different infusion rates, rapid, moderate or slow (0.24, 0.048 or 0.024 mcg per kg body weight per second). A total infusion duration of 10 min will be maintained during each session by adding saline infusions of variable duration after nicotine delivery. This will be achieved by two separate infusion pumps, one for saline and one for nicotine. For example, the rapid 0.24 mcg/kg/s condition will include a 1 min infusion of nicotine followed by a 9 min infusion of saline. The subjects will be blinded to the infusion pump procedures. The rapid delivery rate, which we have used in our prior studies, induces positive subjective drug effects and suppresses symptoms of nicotine withdrawal. The moderate delivery rate,0.048 mcg/kg/s, approximates the rate of nicotine intake encountered while smoking a typical cigarette over 5 min (4). The slowest nicotine delivery rate, 0.024mcg/kg/s, was chosen to approximate the rate of nicotine intake encountered while using a newer EC (5).

Eligibility Criteria:
Inclusion Criteria:

1. Female and male smokers that smoke ≥ 5 cigarettes per day for the past year
2. aged 18 to 30 years
3. urine cotinine levels \> 100 ng/mL consistent with nicotine intake of an active smoker (23)
4. not seeking treatment at the time of the study for nicotine dependence
5. in good health as verified by medical history, screening examination, and screening laboratory tests
6. for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

1. history of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study
2. regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
3. current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine
4. urine drug screening indicating recent illicit drugs use (with the exception of marijuana).
Comparative Mixture of Non-racemic and Racemic Enantiomers of Bupivacaine in Cesarean

The purpose of this study is to determine if the mixture of enantiomers of bupivacaine (bupivacaine S75:R25) dos not represent inferiority efficacy and safety compare to the racemic mixture of enantiomers of bupivacaine (bupivacaine S50:R50).

The enantiomeric mixture of bupivacaine S75:R25 (75% levobupivacaine and 25% bupivacaine) was develop to be a safety regional anesthetic in substitution to racemic bupivacaine (S50:R50).

Eligibility Criteria:
Inclusion Criteria:

* parturients at term
* ASA (American Society of Anesthesiologists) I or ASA II
* elective cesarean section with low risk labor
* pre-natal follow-up
* patient consent

Exclusion Criteria:

* relative or absolute contraindications for spinal anesthesia
* history of hypersensitivity to the local anesthetics
* use of opioids during labor
* labor lasting more than 12 hours or less than 1 hour
* complications of pregnancy such as placenta previa, pre-eclampsia or eclampsia; maternal-fetal malnutrition;important accidents during pregnancy.
* spinal lesions, peripheral neuropathies or any other neurologic disorders that lead to changes of sensitivity and/or motricity
* decompensated diabetes or hypertension
* history of alcohol and/or drug abuse
* cardiopathies, especially myocardiopathies and valvulopathies; important cognitive changes
* changes in safety exams
* twin pregnancy;
* signs of intrauterine distress, and abnormalities of fetal vitality, prematurity
The Effect of Shoulder Mobilization on Muscle Strength and Proprioception: a Randomized Double-blind Study

This randomized, double-blind study examines the acute effects of shoulder mobilization on muscle strength and proprioception in healthy individuals. Forty-eight participants (aged 18-25) were randomly assigned to either a mobilization or sham intervention group. Muscle strength and proprioception were assessed before and after treatment. The mobilization group received passive shoulder joint glides, while the sham group underwent a placebo procedure. The study aims to determine whether mobilization affects strength and proprioception immediately.

Summary of the Study

This randomized, double-blind study investigates the acute effects of shoulder joint mobilization on muscle strength and proprioception in healthy individuals compared to a sham intervention.

Background:

The shoulder joint is highly mobile and prone to injury, with rehabilitation often including manual therapy techniques like joint mobilization. Mobilization may enhance joint stability, neuromuscular control, and proprioception by stimulating mechanoreceptors. However, its immediate effects on shoulder proprioception and strength remain unclear.

Methods:

Participants: 48 healthy university students (aged 18-25) randomly assigned to either the mobilization or sham group.

Assessments: Muscle strength (using a handheld dynamometer) and proprioception (laser pointer-assisted joint position reproduction test) were measured before and after the intervention.

Intervention: The mobilization group received passive shoulder joint glides, while the sham group underwent a placebo procedure without actual joint movement.

Conclusion:

This study aims to determine whether shoulder mobilization has immediate effects on proprioception and strength.

Eligibility Criteria:
Inclusion Criteria:

* Healthy university students aged 18-25 years.

Exclusion Criteria:

* Individuals with orthopedic problems in the shoulder complex.
* Those who have undergone previous shoulder surgery.
* Participants with prior knowledge of joint mobilization techniques that could affect the sham intervention.
Effect of Motivational Interviewing and Game Based Education on Oral Hygiene Behavior of Preschool Children

The purpose of this study was to evaluate the effectiveness of motivational interviewing as well as games in changing oral health behaviors among preschool children.

The participating children, in this randomized controlled clinical trial, were recruited from the governmental preschools available within Edko administration of Beheira governorate, Egypt. A cluster random sampling strategy was used so that the contributors, after fulfilling eligibility criteria, mother/child dyads (pairs) in each nursery were subsequently assigned to the first test group (motivational interviewing MI), the second test group (motivational interviewing MI+ gaming) or the control group (conventional dental health education CE). The children were randomly assigned to the three study groups in the allocation ratio 1:1:1 using random allocation software in blocks of five. The schools' randomization sequence were written on identical sheets of paper and folded inside opaque envelopes that were sealed to be open at the time of intervention implementation.

The three interventions were the conventional dental health education (CE) which were delivered through a 15-minute oral health session given to mothers of preschoolers in the control group whereas in the test groups Motivational Interviewing (MI) for mothers and Games for children were carried out via specific phases.

Eligibility Criteria:
Inclusion Criteria:

* Children having unfavorable oral health behavior (reporting a maximum tooth brushing frequency of 1-2 times/ week).
* The child's mother agreed to join the study so that parent/child can be recruited as pairs/dyads.
* Children enrolled in one of the nurseries selected

Exclusion Criteria:

* Children having a history of serious medical condition or special care needs
* Using any type of removable appliances such as space maintainer or tongue guard.
* Children whose mothers refused to give consent to participate in the study.
* Illiterate mothers who were not able to understand the oral health materials and instructions.
Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma

Locally advanced basal cell carcinoma (BCC) are large BCCs or BCCs located in areas subject to functional and aesthetic risk following surgery or radiotherapy. In these particular situations, surgery and radiotherapy are sometimes not appropriate, and Sonic Hedgehog inhibitors (SHHi) (Vismodegib and Sonidegib) can be proposed. SHHi are effective treatments in laBCC but most CR patients discontinue treatment because of tolerability. Approximately 65% of the population experience a relapse after discontinuation. A few cases of patients treated concomitantly by radiotherapy and vismodegib have been reported in the literature, suggesting that combining vismodegib and concomitant radiotherapy results in an improved overall response compared to a single modality treatment. There is no study evaluating a "consolidation radiotherapy" after complete response to SHHi. We carry out a prospective multicenter study in order to evaluate consolidation radiotherapy in patients with laBCC after achieving complete response with SHHi, with the hypothesis of reducing recurrence after discontinuation of SHHi.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years
* Locally advanced non-recurrent BCC in complete response after first course of SHHi
* Complete response has to be confirmed histologically
* Available photography or CT scan before SHHi treatment allowing delineation of the initial tumor

Exclusion Criteria:

* Patients with distant metastasis
* Patients with Gorlin's syndrome
* Prior radiotherapy to the region of the studied cancer that would result in overlap of radiation therapy fields
* Pregnant women
* Life expectancy less than 1 year
* Inability to receive informed consent
* Inability to participate in the entire study
* Lack of social security coverage
* Refusal to sign consent
EPIPAGE2 Cohort Study Follow up at Five and a Half Years

Epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study implemented to improve our knowledge of the outcome of preterm children in France. This study was launched on March 28, 2011 and includes three groups of preterm children, all born before 35 weeks: extremely preterm infants (born between 22 and 26 completed weeks of gestation), very preterm children (born between 27 and 31 completed weeks) and moderately preterm children (born between 32 and 34 completed weeks).

These children are being studied from their birth up to the age of 12 years. At birth, data on maternal and infants' characteristics were collected from medical records. At one and two years, questionnaires sent to families and to physicians (at two years only) allowed to collect data about the children's life and health.

At five and a half years, medical and psychological assessments are specifically implemented for the study in order to evaluate motor and cognitive disorders in this population.


Eligibility Criteria:
Inclusion Criteria:

* initially included in EPIPAGE 2 cohort or complementary studies or Elfe cohort study
* family agreement to participate to cohort follow up
* informed consent form signed by both parents
* affiliated to social security system

Exclusion Criteria:

* parental refusal
* not affiliated to any social security system
Epidural Intervention of Spinal Nerves With Tumor Necrosis Factor-Alpha Inhibitor

This study is to assess the clinical efficacy of epidural injections with Tumor Necrosis Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis.

This study is to assess the clinical efficacy of epidural injections with Tumor Necrosis Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis.Ninety patients were diagnosed with lumbar spinal stenosis and were randomly assigned to 3 groups, for each group 30 cases. Patients in Group A received epidural injection of spinal nerve with 2.0 ml of lidocaine and 10 mg of Tumor Necrosis Factor-Alpha Inhibitor (etanercept) onto the affected spinal nerve, Group B patients received epidural injection with lidocaine 2ml mixed with 2ml of steroid(Diprospan), and group C patients received epidural injections with 4.0 ml of lidocaine only. All the 3 groups were evaluated by VAS and ODI, and received 6 months' follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of spinal stenosis with radicular pain at least 5 scores of VAS(ranging from 0 to 10).
* Failed to improve symptom significantly through conservative treatment, including physiotherapy, chiropractic therapy, exercise, medication and bed rest.

Exclusion Criteria:

* lumbar surgery history,
* spinal stenosis without radicular pain,
* uncontrollable or unstable use of opioids,
* uncontrolled mental illness,
* pregnant or lactating women,
* patients with a history of adverse reactions or possible adverse reactions to local anesthetics, etanercept or Steroids.