cyrilzakka/clinical-trials huggingface dataset:
A Prospective, Multi-site, Randomized, Sham-Controlled, Double-Blind Trial With One-Way Crossover Designed to Assess the Effectiveness and Safety of the Gimer NeuroBlock SCS Trialing System for the Treatment of Chronic Back Pain and/or Lower Limb Pain

This study is a prospective, multi-site, randomized, shamcontrolled, double-blind trial with one-way crossover designed to assess the effectiveness and safety of the Gimer NeuroBlock SCS Trialing System for the treatment of chronic back pain and/or lower limb pain. The NeuroBlock SCS Trialing System is an ultra-high frequency SCS device for the treatment of patients with chronic back pain and/or lower limb pain who are refractory to conservative pain management. After screening procedures, eligible subjects will enter the study which is comprised of a 1-week randomized testing period, a 1-week follow-up period and 2-week observation period.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 20
2. Subject has been diagnosed with chronic, intractable pain of the trunk and/or limb(s) and is refractory to conservative therapy for a minimum of six months prior to the screening/baseline visit.
3. Subject has an average pain score of back or leg ≥ 5 or maximum pain score of back or leg ≥ 7 on the Visual Analogue Scale (VAS).
4. Subject is willing and able to comply with the procedure and requirements of this trial.
5. The subject is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.

Exclusion Criteria:

1. Subject has the following conditions by investigator's discretion at screening visit or during the last 3 months:

   1. has the mental or psychological condition that affects pain perception or
   2. has difficulty performing objective pain assessment or lack of suitability for participation in the study.
2. Subject has exhibited unstable pain condition within the past 28 days as interviewed by Investigator.
3. Subject has a currently diagnosed coagulation disorder, bleeding diathesis, progressive peripheral vascular disease with PLT \< 100,000/μl or INR \> 1.4 at screening visit.
4. Subject has unstable pain medication(s) for at least 28 days at investigator's discretion.
5. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy.
6. Subject has a current diagnosis of cancer with active symptoms.
7. Subject has a known terminal illness with life expectancy less than one year.
8. Subject has a systematic or local infection, which may increase study risk.
9. Subject currently has an indwelling device that may pose an increased risk of infection.
10. Subject is pregnant or breast feeding.
11. Subject has a medical history of drug or alcohol addiction within the past 2 years.
12. Subject has participation in any investigational study in the last 30 days or current enrollment in any trial.
13. Subject is currently involved in an injury claim law suit or medically related litigation, including workers compensation.
14. Subject is a prisoner.
Mechanisms of Tissue Repair After Muscle Injury and Tendon Strain

The study is a 5-week human study including 24 18-35 year old healthy men. Each participant will have muscle injury and tendon strain induced in one leg using neuromuscular electrical stimulation in conjunction with forced lengthening contractions. The investigators will monitor the recovery from injury/strain over a 4 week period, in which half of the subjects will receive growth hormone (somatropin) to stimulate the connective tissue synthesis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men
* BMI between 18.5-30 kg/m\^2

Exclusion Criteria:

* Smoking
* Regular strength training within the last 3 months
* Current or former use of anabolic steroids or growth hormone
* Use of corticosteroids in the last 3 months
* Use of blood thinning medication
* Use of medication which can affect muscle protein synthesis
* Current or former drug og alcohol abuse
* Knee pain
* Previous participation in studies using deuterated water or alanine tracers
Myofascial Trigger Points of the Levator Scapulae Muscle

Chronic neck pain (CNP) is considered one of the most common musculoskeletal disorders worldwide and myofascial pain syndrome (MPS) is the most prevalent musculoskeletal disorder in the majority of the population. However, normal tissue contractility changes and the different types of myofascial trigger points (MTrPs) measured by tensiomography have not yet been studied. For this reason, the aim of our study is to determine the differences in pressure pain threshold (PPT), tensiomyography and sonoelastography between the palpation zone of control points with respect to active and latent MTrPs in the levator scapulae muscles of subjects with CNP. A single-blind descriptive cross-sectional study is conducted with a convenience sample of 60 points (20 active, 20 latent and 20 control points) on both sides of the subject in the levator scapulae muscles of individuals diagnosed with CNP.

The order of outcome measurements for each point was PPT, manual tension index sonoelastography and tensiomyography separated by 15 minutes. Objective contractile parameters were: contraction time (Tc), mean relaxation time (Tr), maximum radial displacement (Dm), holding time (Ts) and delay time (Td).


Eligibility Criteria:
Inclusion Criteria:

* Bilateral presence of at least one active trigger point.
* One control point and one latent trigger point in the levator scapulae muscles.
* Subjects aged between 18 and 65 years.
* Subjects diagnosed with chronic neck pain for more than 6 weeks.
* Signed informed consent to be able to participate in the study.

Exclusion Criteria:

* Previous treatment for chronic neck pain (within one year) or medical history with a diagnosis of neuropathy.
* Rheumatoid arthritis.
* Myopathy.
* Cognitive impairment or mental disability.
* Skin disorders.
* Pregnancy.
* Activity level of a high-level athlete.
* Medical conditions (fractures, structural deformities and neoplasms).
* Surgical interventions in the cervical-dorsal region or upper extremities.
Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis

Secondary progressive multiple sclerosis (SPMS) is a subtype of multiple sclerosis (MS) for which there are no existing therapies that alter the disease course. This research will utilize cutting edge functional electrical stimulation (FES) cycling technology with the goal of improving walking in individuals with SPMS. The investigators hypothesize that FES cycling will improve walking in subjects with SPMS.

Individuals with secondary progressive multiple sclerosis (SPMS) experience significant impairments in ambulation leading to use of canes, walkers, and ultimately wheelchairs. Treatment attempts for progressive MS have been disappointing. No therapeutic intervention has been shown to modulate disability in patients with SPMS. FES cycling has been shown to have multiple primary medical benefits including: increased muscle mass, improvements in bone density, enhanced cardiovascular function, improved bowel function, decreased spasticity and reductions in bladder infection rate. More importantly FES may modulate the inflammatory central nervous system (CNS) environment in progressive MS. The investigators are proposing a novel, and easy to implement intervention strategy of FES cycling to help improve gait function in individuals with SPMS. A successful outcome on a larger SPMS population would have significant impact towards changing MS clinical care. FES is easily transferable to clinical practice and could potentially ameliorate other complications associated with SPMS such as spasticity, mood and fatigue reducing the burden of health care cost. In addition, the investigators will gain a better understanding of the mechanisms underlying these changes that could be used to design new therapeutic strategies.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of secondary progressive multiple sclerosis
* males and females between the ages of 18 and 65 years
* Expanded disability status scale score between 5.0 and 7.0
* Able to consent to participate in study and are willing to undergo a lumbar puncture and blood draws
* If on on Ampyra or anti-spasticity agent, must be on stable dose for 1 month prior to screening
* No functional electrical stimulation use within 4 weeks
* Participants must be medically stable with no recent (1 month or less) inpatient admission for acute medical or surgical issues

Exclusion Criteria:

* Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
* History of epileptic seizures
* Subjects who have a pacemaker
* Relapse within thirty days prior to screening visit
* Pregnancy
* Subjects having a Stage 2 or greater sacral decubitus ulcer
The Impact of Synergies of Indoor Air Pollutants on Childhood Health and Wellbeing

To quantify health effects of synergizing chemical and biological pollutants in a targeted population setting, i.e., school-aged children. Indoor air pollutants will be monitored within the classrooms with high end sensors. Exposure data from additional sources (outdoor, home, transports) will be obtained. Health outcomes will be assessed prospectively using validated medical procedures and real-time tracking with mobile health (mHealth) equipment and a gamified computer app.

Communication with individual schools and families representing diverse cultural and socioeconomic backgrounds, will be conducted and formal participation consents obtained. The target population will include healthy children and be enriched for children with respiratory allergies and asthma. Provision of instructions, training for participation and baseline assessments of respiratory, immune, and mental health using questionnaires and relevant physiological measurements (e.g spirometry, FeNO), will be performed. Sensors will be positioned and cross-checked for functionality.Health data from the cohort will be monitored by a specifically designed gamified application, as well as by state-of-the-art wearable tracking technology. The app will capture input from the participants at large, while the trackers will accurately, continuously, and remotely, identify personalized patterns of all day activity status, heart rate, oxygen saturation, temperature, blood pressure, sleep, respiratory rate, and mechano-acoustic breathing sounds signatures. Sentinel data will be processed in Work Package 6 and integrated in the SynAir-G autonomous sensing platform.

Children will be prospectively followed-up for a school year. Investigators will regularly visit schools to keep sensors running and collect materials. Real-time tracking will be coupled with regular communication and face-to-face visits for health outcome assessments. Devices will be positioned in selected locations. The cohort will also provide the setting for establishing indoor and outdoor interactions, dose-responses in real life, and health outcome data for integration and synergy analyses.

Eligibility Criteria:
Inclusion Criteria:

1. Students of primary schools aged 8-9 years.
2. The subject and/or legal custodian have the verbal, writing and mental ability to understand the intent and character of the study.
3. Written informed consent from the child's parents/guardian's

Exclusion Criteria:

Unwilling to use the application and follow the procedures of the protocol
Study to Determine the Effect of BMS-791325 on the ECG QTcF Interval in Healthy Subjects

The purpose of this study is to determine whether BMS-791325 has an effect on the electrocardiogram (ECG) interval QT corrected for Fridericia's method (QTcF).

Primary Purpose: Other: This Phase 1 study is a clinical pharmacology thorough QT study.

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy men and women, ages 18 to 49 yr old
* BMI 18 to 32
* Women must not be pregnant or breastfeeding

Exclusion Criteria:

* Any significant acute or chronic medical illness
* A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
* History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
* History of biliary disorders, including Gilbert's disease or Dubin-Johnson disease
* Inability to swallow multiple tablets consecutively
* Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration: PR ≥ 210 msec, QRS ≥ 120 msec, QT ≥ 500 msec, QTcF ≥ 450 msec, Heart Rate (HR) \< 45 bpm
* Second or third degree heart block prior to study drug
* Positive urine screen for drugs of abuse
* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV)-1, -2 antibody
* Any of the following lab results outside of the ranges specified below prior to dosing: Alanine aminotransferase (ALT) \> upper limit of normal (ULN), Aspartate aminotransferase (AST) \> ULN, Total bilirubin \> ULN, Direct bilirubin \> ULN, Creatinine \> ULN, Serum potassium \< lower limit of normal (LLN), Serum magnesium \< LLN
* History of allergy to Moxifloxacin, BMS-791325, nonstructural protein 5B (NS5B) non-nucleoside inhibitors or related compounds
Preoperative Guided Imagery in Patients Undergoing Urologic Surgery

This is a prospective randomized controlled trial of patients undergoing major urologic-oncologic surgery at the University of California, San Francisco (UCSF) Medical Center and the Helen Diller Family Comprehensive Cancer Center. This clinical trial examines the effect of guided meditation before surgery on the levels of anxiety, stress, sleep disturbance, and quality of life among patients scheduled to undergo a major urologic surgery for cancer. A cancer diagnosis and the treatments associated with it can be very stressful for patients, leading to depression, sleep disturbances, and lower quality of life. Mind-body practices such as guided meditation have been used for thousands of years to reduce the effects of chronic stress and to improve quality of life. This clinical trial examines the effects of guided meditation on the stress, depression, and quality of life levels of patients undergoing urologic surgery for their cancer.

PRIMARY OBJECTIVE:

I. To determine the effect of 14 days of preoperative guided visualization meditation on patients' anxiety undergoing major urologic-oncology surgery.

SECONDARY OBJECTIVES:

I. To determine the effect of preoperative guided visualization meditation on patients' depression, stress, and quality of life.

II. To examine the difference in Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey question scores between the two study groups.

III. To determine the ability of patient to perform a daily 23 minute meditation.

IV. To examine the correlation between depression and emergency department (ED) visits and readmissions post-operations.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients listen to guided meditation over 23 minutes daily for two weeks before their standard of care surgery. Patients also complete surveys over 10-15 minutes at baseline, after 10 days, 1 day before standard of care surgery, the day after discharge, and then 4 weeks after surgery.

ARM 2: Patients complete surveys over 10-15 minutes at baseline, after 10 days, 1 day before standard of care surgery, the day after discharge, and then 4 weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years of age.
* Patients undergoing radical cystectomy, radical or partial nephrectomy, or radical prostatectomy at the University of California, San Francisco (UCSF) Medical Center and the Helen Diller Family Comprehensive Cancer Center
* Access to an electronic device that can play mp3 recording and for survey completion
* At least a 2 week window from date of surgical booking to the scheduled surgery

Exclusion Criteria:

* Inability to consent for the study (ie, they have a surrogate decision maker).
* Non-English speaker (the meditations are only available in English)
* Patients scheduled for surgery less than 2 weeks away
Safety Study of RPE65 Gene Therapy to Treat Leber Congenital Amaurosis

The purpose of the study is to determine whether gene therapy is safe and effective for the treatment of severe childhood blindness caused by mutations in RPE65.

The main objective of the proposed trial is to determine the safety and efficacy subretinal administration of a recombinant adeno-associated viral vector (rAAV 2/2.hRPE65p.hRPE65) at three different dosage levels in individuals with autosomal recessive severe early-onset retinal degeneration due to mutations in RPE65. We have a comprehensive clinical monitoring plan to investigate the safety and efficacy of vector delivery.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of severe early-onset retinal dystrophy confirmed missense mutation(s) in RPE65

Exclusion Criteria:

* Visual acuity in the study eye better than 6/36 Snellen
* Hypertension
* Diabetes mellitus
* Tuberculosis
* Renal impairment
* Immunocompromise
* Osteoporosis
* Gastric ulceration
* Severe affective disorder)
* Pregnancy or lactation
Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively (PHEDOPO)

This project aims to study various predictive factors of postoperative pain after oral surgery among different parameters accessible preoperatively, in order to build a predictive model. It also aims to validate the external consistency of the Pain Sensitivity Questionnaire in an odontological context.

This project aims to study various predictive factors of postoperative pain after oral surgery among different phenotypic parameters accessible to preoperative interrogation (anxiety about dental care, personal perception of pain sensitivity, gender, eye color, hair color, blood group) in order to build a predictive model. It also aims to validate the external consistency of the Pain Sensitivity Questionnaire (PSQ) in an odontological context, by studying the relationship between the personal perception of pain sensitivity (measured by the PSQ) and anxiety about dental care (measured by the Corah Dental Anxiety Scale), as well as dramatization in the face of pain (measured by the Pain Catastrophizing Scale).

Eligibility Criteria:
Inclusion Criteria:

* Adult patient, male or female, eligible for dental extraction under local anesthesia,

  * either a tooth on the arch,
  * either wisdom tooth(s) (2 homolateral wisdom teeth (maxilla + mandibular) or a mandibular wisdom tooth).
* Fluent in speaking and reading French.
* Able to give informed consent to research.
* Affiliation to a Social Security scheme.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Contraindication to paracetamol, NSAIDs, tramadol, or anesthetic agents local.
* Patient uncooperative, unlikely or unable to comply with all procedures of the protocol.
* Chronic use of opiates, in a therapeutic or illicit context.
* Chronic depression on long-term antidepressants.
* Stomatological pathology that may interfere with the conduct of the intervention or modify the results: insufficient mouth opening, pathologies of the temporal mandibular joints ...
* Active medical pathology, or any medical condition judged by the investigator to be incompatible with the study.
* Patient under guardianship, curatorship or safeguard of justice.
* Refusal to participate.
Prefrontal Cortex and Abstract Thinking

The capacity of concept formation is not well understood, even if a link is supposed with the functioning of the frontal lobes.

Our aim is to better understand the cognitive mechanisms underlying this function and to try to correlate the performance with atrophy of the frontal lobe in neurodegenerative diseases involving this region (frontotemporal lobar degeneration and progressive supranuclear palsy).


Eligibility Criteria:
Inclusion Criteria:

* informed consent signed
* MMSE\> 20
* No contra indication to MRI

Exclusion Criteria:

* MMSE\<20
Analyzing of The Mother And Father's Parenthood Behaviours at The Early Postpartum Period

There are many physiological and psychological changes in the postpartum period. One of the changes that occur in the family is the process of becoming a parent. Parenthood is a process that begins with the spouses deciding to get pregnant and continues throughout life. The foundations of an individual's future perspective on themselves and the world are largely determined by the parental interactions they experience in the first year of life and their quality. Parenting behaviors exhibited in the early postpartum period show the extent of communication parents have with their babies in later periods. It is also important because it can have short- and long-term effects on the baby. Parenting behaviors are behaviors in which the mother and father show interest in their baby, such as looking at the newborn baby in the postpartum period, asking questions about the baby, smiling at the newborn baby or making noise. Research shows that these behaviors are affected by socioeconomic reasons, the psychological state of the mother and father, their age, whether the pregnancy was planned, and the general health of the newborn. Parenting behaviors should be observed in the prenatal and postnatal period and supported with education when necessary. Parents need to adapt to their changing roles, develop new relationships, and organize their existing relationships according to their new roles. During the transition to parenthood, in addition to the current home and workplace demands, baby care demands are potential stress factors that can disrupt the organization and process of family life and threaten family and marital functioning. During the parental transition, couples with a greater sense of family cohesion willingly take on the challenges of new parenthood, are committed to seeking meaning in the parenting role, and overcome any challenges encountered during the transition, leading to a more satisfying family and marital relationship. Additionally, spousal support and involvement in infant care have been found to be associated with higher satisfaction in marital relationships and family functioning. Research suggests that spousal involvement and support for each other are particularly important for family and marital functioning during the transition to parenthood. Although significant research has been conducted on family and marital functioning during the transition to the parenting role, research on the effects of family cohesion, social support, and stress during the perinatal period on family and marital functioning is limited. This study aimed to examine the parenting behaviors and marital adjustment of mothers and fathers during the postpartum period.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate in the study
* Having a full-term birth (38-42 weeks of gestation)
* No high-risk pregnancy
* Having a healthy newborn
* The couple being married

Exclusion Criteria:

* Illiteracy
* High-risk pregnancy
* Multiple pregnancy
* Prematurity
* Newborn weighing less than 2500g or more than 4000g