cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing

The purpose of this clinical trial is to assess the safety and efficacy of AM3101 to facilitate meniscal repair and reduce the incidence of non-healing complications and morbidities associated with a failed meniscal repair. This is a prospective, randomized, controlled, double-blinded, multi-center study.

Primary Efficacy Objective: Assess the efficacy of AM3101 by evaluating the integrity of repaired meniscal tissue assessed via MRI at 12 months following injection with AM3101 as compared to the integrity of meniscal tissue at 12 months in the control group injected with a saline solution (placebo).

Primary Safety Objective: Assess the safety of AM3101 by evaluating the incidence of individual adverse events and comparing these adverse event rates to incidence rates for the control group injected with a saline solution (placebo).

Secondary Objective: Assess and compare functional outcomes in patients receiving AM3101 following meniscal repair to functional outcomes in the control group injected with a saline solution (placebo).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 and ≤ 40 years old at time of screening.
2. MRI evidence of ACL plus meniscus tear, or isolated meniscus tear.
3. Body mass index (BMI) ≤ 40 kg/m2.
4. Liver and kidney function panels within normal ranges at time of screening
5. Willing and able to comply with the study procedures and visit schedule, and able to follow oral and written instructions.
6. Willing and able to sign an IRB approved informed consent

Exclusion Criteria:

1. Have any concomitant ligament injury requiring surgical repair or reconstruction other than the ACL.
2. Have a history of previous meniscus injury that currently needs to be treated or has been treated surgically.
3. Have evidence of arthritis ≥ Grade III (Outerbridge classification) in the affected compartment or greater than Kellgren Lawrence Grade 3.
4. Elevated AST or ALT liver enzymes at time of screening
5. Pregnant or nursing mothers, or women planning on getting pregnant during the time they will be participating in the study.
6. Known drug or alcohol dependence currently or within the last year.
7. Participating concurrently in another clinical study or have participated in a clinical study within the last 90 days, or intend to during the course of the study.
8. Any medical condition or other circumstances that might interfere with the ability to return for follow-up visits in the judgment of the Investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate postoperative rehabilitation.
9. Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the investigational product's safety and efficacy.
10. Known allergic reaction to simvastatin.
11. Patients currently taking simvastatin, or any other drug that is within the statin drug classification family.
Abces After Incision: Recurrence or Not?

The French School of Proctology assumes that any anal or perianal abscess is related to an anal fistula and therefore requires treatment at the risk of recurrence of the abscess. The Anglo-Saxons, on the other hand, recommend a simple incision in case of a first abscess, without taking care of the possible fistula, on the grounds that more than 60% of patients will not have a recurrence of their abscess. In addition, predictive factors of abscess recurrence have been reported such as female gender, age over 40 years, however, contradicted by other studies. High BMI, corticosteroid use, Crohn's disease are other predictive factors of recurrence while diabetes mellitus or antibiotic therapy during the days following the incision were considered as "protective". The objective of this study was to evaluate our experience in the hospital with essentially a description of the evolution of the patients in the 2 years following the incision of the abscess in consultation.

The main objective is to describe the evolution of patients, within 2 years, who consulted our center for an anal or perianal abscess treated by a simple skin incision under local anesthesia in consultation and/or whose fistula was not found during the examination under anesthesia in the operating room.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 18 years
* Patient who visited between January 1, 2019 and December 31, 2019 for an anal or perianal abscess
* Patient who had a skin incision of a first anal margin or buttock abscess and/or whose fistula was not found during examination under anesthesia in the operating room
* French speaking patient

Exclusion Criteria:

* Patient with pilonidal abscess
* Patient with an intramural abscess
* Patient with a history of anal margin or buttock abscess and/or anal fistula
* Patient with a history of proctologic surgery
* Patient with an abscess whose skin incision under local anesthesia has failed
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his or her data for this research
Natural Soybean-derived Femarelle ®for Patients With Non Alcoholic Fatty Liver Disease

This is a Single -arm, open-label, before-and after exploratory trial of 90 days of Femarelle ® to improve NAFLD and the metabolic syndrome.

Ingestion of Femarelle will improve non alcoholic steatohepatitis and the metabolic syndrome in patients suffering from these conditions.

Subjects will receive treatment with Femarele 530 mg (1 capsule twice a day) for 90 days and will then be monitored off study treatment for an additional 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Biopsy proven NASH
2. If suffering from diabetes may be treated by up to 2 oral medications, with stable doses for 2 months.
3. If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication.

   NOTE: Hormonal-based methods alone are not sufficient. At least two of the following methods MUST be used appropriately unless documentation of menopause, sterilization, or azoospermia is present:
   * Condoms (male or female) with or without a spermicidal agent. - Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV transmission
   * Diaphragm or cervical cap with spermicide
   * IUD
   * Hormonal-based contraception

   Study subjects who are not of reproductive potential (girls who have not reached menarche or women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy are eligible without requiring the use of contraceptives. Written or oral documentation communicated by clinician or clinician's staff is required by one of the following:
   * Physician report/letter
   * Operative report or other source documentation in the patient record (a laboratory report of azoospermia is required to document successful vasectomy)
   * Discharge summary
   * Laboratory report of azoospermia
   * FSH measurement elevated into the menopausal range as established by the reporting laboratory.
4. Ability and willingness of subject or legal guardian/representative to provide informed consent.

Exclusion Criteria:

1. Pregnancy or Breast-Feeding
2. Continuous use of the following medications for more than 3 days within 30 days of study entry:

   * Immunosuppressives
   * Immune modulators
   * Systemic glucocorticoids
   * Anti-neoplastic agents
3. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
4. Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
5. Surgery within the previous 3 months.
6. Any serious infectious, cardiac, pulmonary, or kidney disease
7. Hypersensitivity to Femarelle ®
8. Malignancy of the uterus or breast
9. Past thromboembolic event
Cerebral Microembolization Associated With PFO Closure

This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within PFO.

Patent foramen ovale (PFO) is prevalent in the general population and it is commonly accepted that PFO is associated with various pathological conditions, including ischemic stroke, transient ischemic attack, migraines, and systemic or coronary embolization. In situ thrombus formation may play a role in patients with PFO-associated stroke or migraines. After transcatheter closure of PFO, peri-interventional cerebral embolic lesions have been detected. This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within PFO.

Eligibility Criteria:
PFO group

Inclusion Criteria:

1) age 18 to 65 years; 2) documented PFO with medium-to-large shunts (≥ 20 microbubbles by c-TCD at rest or during the Valsalva maneuver); 3) history of embolic stroke (based on brain magnetic resonance imaging within 24 hours after symptom onset) or TIA within 6 months without other identifiable causes; 4) history of migraine for more than one year without other identifiable causes; 5) asymptomatic group: incidental finding of PFO in asymptomatic individuals, and presence of high-risk activities and/or anatomical features related to PFO (high-risk activities were defined as those in which the Valsalva maneuver was performed frequently or those that increased the risk of venous gas formation; and high-risk anatomical features included atrial septal aneurysm and/or curtain pattern on c-TCD).

Exclusion Criteria:

1) presence of any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity; 2) history of embolic stroke or TIA within the past one month; 3) history of deep vein thrombosis or pulmonary embolism; 4) presence of coronary artery disease and carotid artery lesions; 5) presence of coexistent cardiovascular structural malformations or diseases; 6) allergy to contrast medium; 7) refusal to participate.

ASD group

Inclusion Criteria:

1) age 18 to 65 years; 2) secundum ASD size 10 to 20 mm, with sufficient surrounding rims, except the aortic rim; 3) right heart catheterization: resting SPAP \< 50 mm Hg, Qp/Qs ≥ 1.5 and PVR \< 5 WU.

Exclusion Criteria:

1) presence of any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity; 2) associated with other cardiac abnormalities or diseases; 3) resting SPAP ≥50 mm Hg and resting PVR ≥5 Wood units;4) primum or sinus venosus type ASD; 5) presence of intracardiac thrombi, permanent contraindications to platelet therapy, and allergic reaction to nickel.
Assessment of Musculoskeletal Pain and Psychosocial Status of Athletes

The sporty performance exhibited by an athlete faces physiological, biomechanical and psychological activity of the athlete. It depends on both the psychological state and the elevation of the musculoskeletal system to a certain level so that the athlete can perform optimally and excellently. For this reason, we aimed to evaluate the musculoskeletal system pain of amateur and professional athletes in different disciplines and the psychosocial states such as sports confidence, depression and quality of life.

This study consists of 80 amateur and 80 professional sportsmen who are participating in sports by doing sports in soccer, basketball, volleyball, athletics, table tennis, field tennis, folk dances, kickboxing and archery branches between the ages of 15 and 36. The Expanded Scandinavian Muscle Skeleton Questionnaire (NMQ) and Visible Analogue Scale (VAS) will be used to identify and assess the symptoms of musculoskeletal discomfort as 'pain'. The participant will be evaluated with the algometer, the sporty trust will be questioned with the Sporty Trust Continuous Inventory, and the Quality of Life will be assessed with the World Health Organization Quality of Life Scale Short Form and Depression will be evaluated with Beck Depression Inventory.

Eligibility Criteria:
Inclusion Criteria:

* The athletes and their coaches must be voluntary and willing.
* During the evaluation, the athletes must give careful and relevant answers to the measuring instruments.
* They have to actively run the sport they belong to.

Exclusion Criteria:

* Having undergone a surgical operation due to sports injuries in the last 3 weeks
* The athletes do not want to answer the surveying instruments
Continuous Serrates Plane Block in Axillary Dissection

Patients undergone to axillary dissection during breast surgery with a PECS I, II block will be randomized to receive either a serratus plane continuous local anesthetic infusion through a multiple hole catheter or nothing. Both groups will receive a patient controlled analgesia with morphine.

84 patients ASA I-III undergoing breast surgery with axillary dissection after modified PECS II block as described by Blanco et al. with Ropivacaine 0.37% 30 ml. General anesthesia with remifentanil 0.1 mcg/Kg/min and Propofol 1.5-2 mg/Kg to facilitate endotracheal intubation will provide for all patients, and maintained with Desflurane and Remifentanil infusion. In case of axillary dissection patient will be randomized to receive either a serratus plane continuous local anesthetic infusion through a multiple hole catheter or nothing. Both groups will receive as intraoperative analgesia 1 g Acetaminophene ev 30 minute before the end of the surgery and 1g. 8h-1 postoperative associated to a patient controlled analgesia with morphine. PCA will set up as follow: bolus 1 mg, lock-out 6 minute, max 20 mg/4h. In the serratus group 10 ml of Ropivacaine 0.5% before fascial closure and a continuous infusion of 12 ml/h of Ropivacaine 0.2% will be provide.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* breast surgery
* informed consent

Exclusion Criteria:

* ASA \>3
* allergy to local anesthetic
* opioid administration in the last month
* patient refusal
Monitoring Neural Tissues Properties by Modulated Imaging (MI)

We have developed a safe, non-contact, intra-operative guidance system to optimize tumor resection in neurosurgery. The Modulated Imaging is non-contact optical imaging technology developed at the Beckman Laser Institute, UCI.

Compared to other imaging approaches, MI has the unique capability of performing both diffuse optical tomography and rapid, wide-field quantitative mapping of tissue optical properties within a single measurement platform.

Preliminary in vivo studies have shown that brain tumors, infiltrating tumor margins and normal brain may have intrinsically different optical properties.

While compatible with time-modulation methods, MI alternatively uses spatially-modulated illumination for imaging of tissue constituents.

The Modulated Imaging system consists of

1. a light projection system that illuminates the tissue with spatial sinusoid patterns.
2. a CCD camera which collects the diffusely reflected light in a non-contact geometry. The wavelength of illumination can be selected by bandpass filtering of a broadband source,or by use of a monochromatic source.

Lastly, tissue fluorescence measurements can be performed by placing a combination of source-blocking and bandpass emission filters in front of the camera.

The diffusely reflected amplitude of the modulated wave carries both optical property (absorption, fluorescence, scattering) and depth information. Specifically, the sampling depth of the spatially-modulated wave is a function of the frequency of illumination and the tissue optical properties.

During neurosurgery when nervous tissue is exposed by the attending neurosurgeon, intraoperative pictures will be taken using the modulated imager by the investigators.

The imaging procedure may delay completion of the surgical case by an estimated 10 to 20 minutes. This is minimal prolongation considering most brain tumor resections take several hours.

The images acquired will be processed after the surgical procedure and will not be available to the surgeon during the operative procedure.

Eligibility Criteria:
Inclusion Criteria:

* All nervous system tumor patients who undergo a preoperative MRI,and undergoing central nervous system operative procedures for non tumor.

Exclusion Criteria:

* All emergency neurosurgical procedures.
Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy

The injection of botulinum neurotoxin A into the prostate represents an alternative, minimal invasive treatment in patient with lower urinary tract symptoms (LUTS) associated to benign prostatic hyperplasia (BPH).

Objective: To evaluate the effectiveness of BTA in treating patients with symptomatic BPH and unsatisfactory response to combined medical therapy.


Eligibility Criteria:
Inclusion Criteria:

* Moderate-to-severe LUTS as determined by the International Prostate Symptom Score
* Mean peak urinary flow rate of no more than 15 mL/s with a voided volume of at least 150 mL, or postvoid residual urine volume (PVR) of more than 100 ml and urodynamic parameters indicative of bladder outlet obstruction (BOO) according to International Continence Society

Exclusion Criteria:

* Patients with neurogenic voiding disorders, prostate or bladder cancer, bladder stones, urethral stricture, chronic bladder catheterization were excluded from the study.
Axillary Reverse Mapping for Breast Carcinomas

Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest.

Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest. The assumption is that the sentinel node (SN) of the upper limb is different from the SN of the breast and that it is uninvolved after metastatic involvement of the axillary nodes in relation to the breast. During the ARM procedure, it is necessary to use an injection of a lymphatic tracer into the upper limb in order to visualize the lymphatic arm drainage.The ultimate goal for ARM procedure is to reduce the rate of lymphedema in N+ patients requiring an AD.

Eligibility Criteria:
Inclusion Criteria:

* Indication for formal Axillary Dissection (AD)
* N0 patient with a large tumor: T3
* N1 patient
* N2 patient with axillary imaging showing limited node involvement(1-4N+).
* Secondary AD after a positive sentinel node ( pN1, pN1(mi))
* AD after préopérative chemotherapy in a patient initially N+.
* Age between 18 and 70
* Signature of the consent form.
* Patients beneficiary of the Social Security

Exclusion Criteria:

* N0 patient with an indication of Sentinel Node biopsy
* N2 patient with axillary imaging showing suspected node involvement \>4N+.
* N3 patient
* Age over 70
* Pregnancy
* Blue dye allergy
* Mentally deficient patient
Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression

The goal of this study is to determine whether indiplon, when administered with sertraline, improves insomnia symptoms and depressive symptoms in subjects with both insomnia and depression.

This Pfizer run study stopped due to the co-development program for indiplon being terminated between Pfizer and Neurocrine. The study was terminated on 16 November 2006. There were no safety issues leading to the decision to terminate this study.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV defined insomnia
* DSM-IV defined Major Depression

Exclusion Criteria:

* Current suicidal ideation or behavior
* Primary sleep disorder other than insomnia
The Effect of FODMAP Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement

This study aimed to investigate the effects of FODMAP contents in enteral nutrition (EN) formulas on major gastrointestinal intolerance symptoms and nutritional status in tube fed patients through the randomized, double blind and placebo-controlled trial.

A randomized, double-blind, placebo-controlled study was conducted on 100 tube-fed patients. Over a 14-day test period, the test group consumed EN formula containing low FODMAPs, while the placebo groups consumed EN formula containing moderate or high FODMAPs .

Eligibility Criteria:
Inclusion Criteria:

* tube-feeding patients

Exclusion Criteria:

* EN prohibited
* renal dysfunction (i.e. serum creatinine \> 1.5 mg/dl or blood urea nitrogen \> 25 mg/ml)
* liver dysfunction (i.e. serum aspartate aminotransferase \> 40 U/L or alanine aminotransferase \> 40 U/L)
* uncontrollable diabetes mellitus
* pregnancy, breast-feeding etc.
* severe diarrhea
Posture Training and Cerebellar Stimulation in Elderly People

Motor learning relies on both feedback and feedforward mechanisms to keep progressive optimization of motor behaviors in a coordinated manner. Error correction based on the fronto-parietal loop is subject to error information inherent within visual feedback. On the other hand, cerebellar activity for restoration of efferent copy involves in operation of feedforward mechanism. Therefore, the amount of error feedback and excitation of cerebellum are keyed to effectiveness of motor learning. Although postural training is of empirical value to prevent falling from the elderly, yet none of previous studies have ever been devoted to improve effectiveness of postural training via manipulations of visual error feedback and cerebellar stimulation.

From the aspect of cognition-motor interaction, the present proposal is a three-year project intended to promote effectiveness of postural training for the elderly. In the first year, feedback-based training benefits from a dynamic postural task under the conditions of different visual size of error feedback (error-reducing feedback, error-enhancing feedback, and fixed error feedback) will be contrasted. In the second year, feedforward-based training benefits from a dynamic postural task by application of cerebellum transcranial electrical stimulation (ctDCS) of different modes (direct current vs. noise vs. sham) will be contrasted. In the third year, the proposal will examine whether postural training with combined approach (error-enhancing feedback and ctDCS) could result in a superior training benefit to those of error-enhancing feedback alone and ctDCS alone approaches. In addition to innovative training intervention, this proposal will make use of current non-linear analyses on EEG signals and postural sway with graph analysis and heading analysis, respectively. It is expected to gain additional insight into behavior and brain mechanisms underlying learning-related changes with the postural training, potentially lending to a more effective training paradigm for postural stability of the elderly.


Eligibility Criteria:
Inclusion Criteria:

* Age above 60 years old healthy older adults without a history of falls.
* Able to understand and give informed consent.
* The Mini-Mental State Examination test score above 25-30.
* Lower limb muscle strength is evaluated as G grade
* The corrected visual acuity was within the normal range.

Exclusion Criteria:

* Any known history of mental illness
* Any neuromuscular or degenerative neurological disease(ex:stroke、SCI、TBI...etc)
* Any known history of cerebral cerebellar disease or intracranial metal implants.
* Weak of hearing or wearing a hearing aid