cyrilzakka/clinical-trials huggingface dataset:
Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)

Number of centres planned : 1 (CHU Nantes)

Design : Randomized, Prospective

Planning of the study :

* Total duration: 34 months
* Recruitment period: 24 months.
* Follow-up time per patients : 7-10 months

Expected number of cases : 12

Treatment, procedure, combination of procedures under consideration :

During the study, patients will be implanted with the WAVEWRITER ALPHA™ system with the objective of decreasing patient pain with a spinal cord stimulation mode.

There will be a random draw on the order of the stimulation program:

* the tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibers of the posterior cords of the spinal cord induces local paresthesias
* burst stimulation (or "burst")
* high frequency" stimulation (1000 Hz) "High frequency: HF".
* combined tonic + burst stimulation
* combined tonic + high frequency stimulation


Eligibility Criteria:
Inclusion criteria:

* Patients aged 18 to 85 years
* Patients with chronic neck and upper limb pain (according to HAS criteria for spinal cord stimulation)
* Patients must be able to give informed consent and must have signed an informed consent
* Affiliation to the health insurance
* A negative pregnancy test for women of childbearing potential
* Women of childbearing potential must use an appropriate contraceptive method(s) during the clinical trial

Non-inclusion criteria:

* Drug or alcohol abuse
* Any medical or psychological problem that may interfere with the proper conduct of the study protocol (e.g., cancer with limited life expectancy)
* Difficulty with follow-up
* Pregnant or breastfeeding women
* Women of childbearing potential who are not using contraception
* Adults under legal protection (guardianship, curatorship, "sauvegarde de justice") or deprived of liberty
* Exclusion period for another study
* Participation in another interventional study whose primary objective is based on pain.

Exclusion criteria:

- 7-day post-implantation test phase negative
Treatment for Obesity and Binge Eating Disorder

This study is a test of cognitive behavioral therapy(CBT) and behavioral weight loss (BWL) treatments for obese patients with binge eating disorder (BED). The study involves a comparison of three treatment conditions: (1) CBT; (2) BWL, and (3) a sequential (two-part) treatment consisting of CBT followed by BWL.


Eligibility Criteria:
Inclusion Criteria:

* Binge Eating
* Overweight

Exclusion Criteria:

* Pregnancy
* Current cardiac disease
* Serious neurologic illnesses
Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Tacrolimus in Healthy Volunteers

This study characterizes the pharmacokinetic effects of ASP015K on Tacrolimus in healthy volunteers.

The subjects will be confined to the unit for 13 days and have a brief follow-up visit to obtain hematology blood samples. Numerous blood and urine samples will be taken to determine the pharmacokinetics of the drugs.

Eligibility Criteria:
Inclusion Criteria:

* If female, the subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
* If male, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
* Subject is medically healthy, with no clinically significant medical history or abnormalities observed upon physical examination or 12-lead electrocardiogram (ECG)
* Subjects must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2

Exclusion Criteria:

* Subject has a history of chronic diarrhea
* Subject has been vaccinated within the last 60 days prior to study drug administration
* The subject has a previous history of any clinically significant neurological, gastro-intestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease
* Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
* Subject has a history of the human immunodeficiency virus (HIV) antibody
* The subject has an absolute neutrophil count (ANC) \< 2500 cells/mm3 Subject has had clinically significant illness within 1 month prior to study drug administration
* Subject has a recent history (within the last 6 months) of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse/illegal drugs
Duchenne Muscular Dystrophy Video Assessment Registry

ARISE is a prospective and longitudinal clinical study of individuals with Duchenne Muscular Dystrophy (DMD) aimed at creating a database of functional motor abilities in this population to support validation efforts of the Duchenne Video Assessment (DVA).

ARISE is a longitudinal, observational study of individuals with Duchenne muscular dystrophy (DMD). The Duchenne Video Assessment (DVA) is a home-based clinical outcome assessment that measures ease of movement through identification of compensatory movement patterns. The DVA directs caregivers to video record patients doing specific movement activities at home using a secure mobile application. In this study, participants will remotely complete the DVA in addition to existing DMD functional assessments (North Star Ambulatory Assessment (NSAA) and Performance of Upper Limb (PUL 2.0)) to evaluate the longitudinal measurement properties of the DVA.

Eligibility Criteria:
Inclusion Criteria:

* At least 2 years of age at time of consent
* Written consent (English only) by adult participant or parent/legal guardian of minor participant
* Written assent (English only) if minor participant is at least 7 years of age
* Documentation provided for the participant's diagnosis of DMD (i.e., genetic report, clinic note)

Exclusion Criteria:

Participants will be excluded if they are unable to use a hand to hold a pen, pick up pennies or drive a powerchair.
Omic Approaches to Neurodevelopmental Disabilities

to bridge the gap between the molecular structure of CNV and the effect on the phenotype, considering NDDs as complex diseases, as they are a consequence of the imbalance in several dosage-sensitive genes, we might try to approach them through different --omics investigations (genomics, epigenomics, transcriptomics) according to the emerging field of network medicine. This holistic can provide valuable insight into understanding peculiar molecular mechanisms and unsuspected molecular interactions that contribute to the pathogenesis of the condition and possibly pave the way for uncovering new drug strategies that even if they do not heal the patient may improve his performance and the social interaction


Eligibility Criteria:
Inclusion Criteria:

Patients with neurodevelopmental disorders carrying a genomic rearrangement identified through chromosomal microarray analysis (CMA)

Exclusion Criteria:

NA
BioHPP Hybrid Prosthesis Versus BioHPP Bar Implant Supported and Retained Overdenture Rehabilitating Edentulous Mandible

The biggest challenge of oral rehabilitation is the replacement of lost structures and the restoration of their function and esthetics, focusing on matching a healthy tooth.

Traditional complete dentures, implant (retained, supported) overdentures, and complete implant-supported fixed prostheses are all alternatives to the rehabilitation of the mandibular arch.

The aim of this study was to compare BioHPP used as a skeletal substructure for hybrid (implant fixed, detachable) prostheses versus BioHPP bar supporting and retaining by using radiographic tracing to the marginal bone height changes around the implants, patient satisfaction can be improved.

Fourteen completely edentulous male patients were selected from the out-patient clinic, Prosthodontic Department, Faculty of Dentistry, Ain Shams University, according to certain criteria, and they were randomly allocated into two equal groups: group I: the seven patients were rehabilitated by the BioHpp hybrid prosthesis supported on four inter-foraminal implants; group II: While in group II, seven patients were rehabilitated by the BioHpp bar supported and retained overdenture.

The upper and lower complete dentures were constructed following conventional methods, and the surgical guide was constructed according to dual-scan CBCT.

the four parallel inter-foraminal implants were inserted in the mandible for each patient through used the surgical guide ( flapless technique ) After three months from the first surgery, the final prosthesis was constructed.

For Group I; BioHpp fixed hybrid prosthesis, for Group II; BioHpp bar implant-supported and retained complete overdentures were created using digital workflow CAD/CAM.

The crestal bone height loss was evaluated after six, twelve, and eighteen months from implant loading by using digital preapical radiography. Also, the patient's subjective evaluations by using a questionnaire based on the visual analog scale including five points (low dissatisfied, dissatisfied, fair, satisfied, highly satisfied) were evaluated for speech, chewing, comfort aesthetic, oral hygiene, and general satisfaction.

A comparison between groups I and II was performed by using the Chi-square test, which revealed in the results that group II was significantly lower than group I at all intervals in the mesial and distal surfaces of anterior and posterior implants. Also, the results of the patient satisfaction revealed that, after 6 months, there was an insignificant difference between them as P \> 0.05 in all except oral hygiene, as satisfaction was significantly higher in group II than in group I. While, after 12 months, there was an insignificant difference between them all (P \> 0.05).

Eligibility Criteria:
Inclusion Criteria:

1- sufficient inter arch distance. 2. good oral hygiene. 3. Enough bone volume in interforaminal region.

Exclusion Criteria:

1. TMJ disorders.
2. Radiotherapy or chemotherapy.
3. Diabetes mellitus
4. Uncooperative patients
Evaluating the Physiological Strain Induced by a BC Membrane Protective Garment Under Exercise-heat Stress Compared to a Protective Coverall

Israel ministry of defense is examining a new BC membrane protective garment of BLAUER company constructed with GORE CHEMPAK fabric for the border guard of the police forces. The goal of this research is to perform a comparative experiment in order to evaluate the physiological strain induced by the new protective garment under exercise-heat stress conditions, compared to protective garment in current use.

In order to physiologically evaluate a new BC membrane protective garment for the Israeli police use under exercise-heat stress conditions, 12 healthy volunteers from the border guard will participate in this study.

The subjects will undergo 4 experiment days: Recruitment day, one day of acclimatization to heat, and 2 days of performing experiment protocol, each day dressed with different protective garment (Protective garment in current use + NBC mask, new BC membrane protective garment + NBC mask).

Core (rectal) and skin temperature and heart rate will be monitored continuously, liquid balance will be recorded.the physiological heat strain will be assessed and compared between the different protective garments.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-40 years.
* Healthy civilian volunteers.
* Without known medical illness or medication use.

Exclusion Criteria:

* The existence or suspicion of existing cardiac or respiratory disease.
* Hypertension.
* Diabetes.
* Psychiatric condition.
* Any muscles or skeleton condition.
* Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
* Infectious disease 3 days prior to the experiment.
Cryosurgery in Treating Women With Breast Lesions

RATIONALE: Cryosurgery kills cancer cells by freezing them. Cryosurgery followed by lumpectomy or mastectomy may be an effective treatment for breast lesions.

PURPOSE: Phase I trial to study the effectiveness of cryosurgery in treating women who have breast lesions.

OBJECTIVES:

* Determine the feasibility of temperature-monitored, ultrasound-guided cryosurgery in women with highly suspicious breast lesions.
* Determine the safety of this procedure in these patients.

OUTLINE: This is a multicenter study.

Patients undergo cryoablation of up to two breast lesions. Within 3-21 days, patients undergo lumpectomy or mastectomy.

Patients are followed at 1, 4, 8, and 12 weeks after lumpectomy or mastectomy.

PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Highly suspicious breast lesion on prior mammogram and/or ultrasound with confirmation of malignancy on ultrasound-guided core biopsy

  * Tumor no greater than 2.0 cm in diameter
* Eligible for lumpectomy or mastectomy
* No superficial breast lesions
* No prior open surgical biopsy
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* Any age

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics
* No other surgery that would preclude study participation

Other:

* No other medical treatment that would preclude study participation
Panitumumab Plus FOLFIRI in First-line Treatment of Metastatic Colorectal Cancer

To estimate the effect of KRAS mutation status (Wild-type versus Mutant) on objective response rate and other measures of efficacy for patients treated with panitumumab in combination with a chemotherapy regimen of irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as first-line therapy for metastatic colorectal cancer (mCRC).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with histologically- or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum.
* Measurable disease according to modified RECIST guidelines.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
* Paraffin-embedded tissue or unstained tumour slides from primary or metastatic tumour available for central lab analysis.
* Adequate haematologic, renal, hepatic and metabolic function.

Exclusion Criteria:

* Central nervous system metastases.
* Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to initiating study treatment.
* Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (e.g. cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g. erlotinib).
* Prior radiotherapy within 14 days prior to screening, and for which all signs of early radiological toxicity have not abated.
* Significant cardiovascular disease including unstable angina or myocardial infarction within six months before initiating study treatment or a history of ventricular arrhythmia.
* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest computed tomography (CT scan.
* Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as \> 4 loose stools per day).
* History of Gilbert's syndrome or dihydropyrimidine deficiency.
* Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection.
* Any investigational agent within 30 days before initiation of study treatment.
* Must not have had a major surgical procedure within 28 days prior to initiation of study treatment.
* Subject who is pregnant or breast-feeding.
* Woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for six months after the last study drug administration for women, and one month for men.

  * Other protocol specified criteria and specific details may apply.
Effectiveness of Infiltration With Resin in Treatment of MIH Incisors in Children Showing Opacities

Enamel development defects are the result of a set of environmental, systemic and genetic causal agents that reveal a multifactorial etiology model, which in anterior teeth produces a serious aesthetic problem, converted into a problem of visual perception. In hypomineralized enamel, light rays encounter multiple interfaces between organic and mineral fluids, with different refractive indices. At each interface, the light is deflected and reflected, producing an overexposed "optical labyrinth" that is perceived as a yellow, white, or brown stain.

The term "infiltration" has been modified and developed commercially in Germany for the treatment of non-cavitated caries on smooth and proximal surfaces, in which the porosities of the enamel lesion are infiltrated with a low-viscosity resin, thus creating a barrier of diffusion, without the need for any type of additional material on the tooth surface.

An added positive effect of infiltration with the queens is that the enamel lesions lose their whitish appearance when the microporosities are filled, mimicking the area of the lesion with the remaining healthy enamel. This effect is what has led clinicians to adapt this treatment for the management of enamel defects.

Given the growing interest in the treatment of opacities in the anterior sector, due to the demanding contemporary aesthetic requirements, and the increased acceptance of minimally invasive therapies, the need has been seen to seek greater predictability for the treatment of defects. of conservative enamel from an early age and offer effective therapeutic alternatives.


Eligibility Criteria:
Inclusion Criteria:

. Pediatric patients, aged between 9 and 16 years.

* Patients who have molar incisor hypomineralization, any lesion with isolated opacities or discoloration of the permanent incisors.
* Patients who present at least one opacity in the central incisors.
* Go to the dental clinic for revision or treatment of the University of Valencia.

Exclusion Criteria:

* Opacities with loss of enamel or tooth structure, active caries lesions, clinical symptoms of irreversible pulpitis such as spontaneous pain or persistent pain, a history of using bleaching agents, with intolerance to any milk protein, who have an allergic pathology or syndromic or uncooperative during the clinical procedure.
ESPB Versus PVPB Regarding Their Effect on Peri-operative Opioid Consumption in Patients Undergoing Minimally Invasive Mitral Valve Replacement

In recent years , the popularity of ultrasound-guided fascial plane blocks has increased in achieving an effective postoperative analgesia and hence achieving enhanced recovery after surgery (ERAS) .

Mastering the use of ultrasound encourages anesthetists on the frequent use of regional anesthesia . Fascial plane blocks are increasingly becoming a part of multimodal analgesia as an alternative pain management strategy in cardiac surgery. Various regional techniques especially paravertebral plane blocks have been recently described to reduce the postoperative pain in cardiac surgery with enhanced recovery . Ultrasound-guided erector spinae plane block is a recently introduced technique for regional analgesia in thoracic neuropathic pain, rib fractures, and breast surgeries. This study aims to compare between the two techniques regarding their peri-operative analgesic effect and their impact on enhanced recovery after surgery.

This study aims to compare between the effectiveness of Erector spinae plane block and thoracic paravertebral plane block in reducing the perioperative need of opioids in patients undergoing minimally invasive mitral valve replacement as part of ERAS.

Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists (ASA) score III.
* Patients aged ≥ 18 years old.
* Patients scheduled for minimally invasive mitral valve replacement through a right mini thoracotomy.

Exclusion Criteria:

* Patients refusing to be involved in this study.
* Patients with ASA score \> III.
* Patients aged \< 18 years.
* Patients with local infection at the site of needle puncture.
* Patients with known hypersensitivity to local anesthetic (LA).
* Patients with hepatic or renal impairment.
The Effects of Pilates Training on Exercise Capacity and Respiratory Muscle Performance in Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with significant functional impairment and increased risk for cardiovascular and pulmonary disease. Along with pharmacological therapy, exercise seems to be a very promising intervention to improve disease-related outcomes, including functional capacity and systemic manifestations. Despite the fact that aerobic and strengthening exercises have been shown to be useful in patients with RA, there have been limited research on the effects of pilates training. Therefore, we aimed to investigate the effect of clinical pilates training on exercise capacity, respiratory and peripheral muscle strength, respiratory muscle endurance, respiratory function, pain, balance, core stability, dyspnea, functional status, fatigue, quality of life, depression and anxiety in patients with RA.

According to sample size calculation 30 patients with RA will be included. Patients will be evaluated before and after treatment. Patients will be randomized into exercise and control training groups. In the exercise training group the patients will be given pilates exercise; in the control training group, the patients will be given relaxation exercise. Pilates exercises will be applied by the physiotherapist 3 days a week for 8 weeks. The patients in the control training group will be given relaxation exercises as a home exercise program 3 days a week for 8 weeks. Exercise capacity, pulmonary functions, respiratory and peripheral muscle strength, respiratory muscle endurance, pain, balance, core stability, dyspnea, functional status, fatigue, quality of life, depression and anxiety will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Being diagnosed according to the American College of Rheumatology (ACR)/EULAR 2010 rheumatoid arthritis diagnostic criteria
* under standard medications

Exclusion Criteria:

* orthopedic or neurological disease with a potential to affect functional capacity
* have problems that can prevent evaluation
* have a neurological problem that may cause hearing or vision impairment
* changes in medical treatment in the last 3 months
* have high disease activity score (DAS-28\>3.2)