cyrilzakka/clinical-trials huggingface dataset:
Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: A Randomized Clinical Trial

The goal of this interventional study is to test of efficacy of sacral Transcutaneous Electrical Stimulation (TENS) in patients with chronic pelvic pain.

The main questions it aims to answer are:

1. Is sacral transcutaneous electrical stimulation (TENS) effective to reduce/relief pain in patients with chronic pelvic pain?
2. Is the effect of TENS comparable to sham stimulation therapy in patients with chronic pelvic pain?

Our study aiming to test the efficacy of sacral transcutaneous electrical stimulation (TENS) intervention in patients with chronic pelvic pain. We aim to test the efficacy and compare it with sham stimulation therapy in chronic pelvic pain.

Eligibility Criteria:
Inclusion Criteria:

* Female with chronic pelvic pain for ≥6 months
* 18-65 years old
* Visual Numeric Scale of Pain score ≥4/10
* Voluntarily participate to the study

Exclusion Criteria:

* Pregnancy
* Having severe medical and/or psychiatric disorder
* Malignancy
* Chronic infection
* Inflammatory musculoskeletal system disease
* Skin infection in sacral/pelvic area
* Having implanted neuromodulatory device (such as pacemaker or defibrillator)
* Refusing to participate the study
Effects of Moringa Oleifera Leaves on Glycemia, Lipemia and Inflammatory Profile in Prediabetic Patients

Moringa oleifera (MO) is a traditional food in tropical and subtropical areas and has attained a growing interest for its medicinal properties. It's a nutrient-rich vegetable, high in protein and polyphenol content. The MO dry leaves and leaf extracts have been shown to exert numerous in vitro activities and in vivo effects, including the hypoglycemic effect. Thus, MO could be an alternative to prevent or treat diabetes. Studies in humans, however, are still limited. This proposal aims to study the efficacy of Moringa oleifera to improve the control of glycaemia in subjects with prediabetes. A 3-month dietary intervention with MO dry leave capsules will be performed and compared to placebo.

The tree Moringa oleifera (MO) is a traditional medicinal plant in tropical and subtropical areas, also consumed as food, which is currently expanding worldwide as a protein-rich leafy vegetable and for the medicinal value of its phytochemicals, in particular its glucosinolates. Specifically, MO dry leaves and leaf extracts have been shown to exert numerous in vitro activities and in vivo effects, including the hypoglycemic effect. Thus, MO could be an alternative to prevent or treat diabetes. In this sense, in vitro and preclinical experiments have shown that MO could potentially reverse some of the pathophysiological manifestation of diabetes and its comorbidities, such as hepatic fat accumulation and insulin resistance, oxidative stress, inflammation and peripheral hyperglycemia. Studies in humans, however, are still limited. This proposal aims to study the efficacy of Moringa oleifera to improve the control of glycaemia in subjects with prediabetes. A 3-month dietary intervention with MO dry leave capsules will be performed and compared to placebo. This will be a double-blind, randomized, placebo controlled, parallel group intervention study. Subjects will randomly consume either 6 capsules of dry MO leaves (400 mg dry leaf powder /capsule) or 6 placebo capsules per day during 3 months. The study subjects will provide samples for outcome measurements at three different time points: basal, 6 weeks and 12 weeks of supplementation. Glycaemia and plasma inflammatory and metabolic markers will be measured, as well as the gut microbiota composition.

Eligibility Criteria:
Inclusion Criteria:

* Prediabetes: HbA1c between 5.7-6.4 % or fasting blood glucose between 100 - 125 mg/dl or impaired glucose tolerance (\> 140 mg/dl and \< 200 mg/dl two hours post oral challenge).
* No pharmacological treatment prescribed for glycemia control.

Exclusion Criteria:

* Diabetes Mellitus
* Impaired renal function: \< 60% Glomerular filtration
* Uncontrolled high blood pressure
* Previous cardiovascular events or coronary disease
* Autoimmune disease
* HIV
* Severe gastrointestinal disease
* Cancer
* Psychiatric illness
* Elevated liver enzymes (x2 normal range)
* Alcohol abuse (higher than 14 and 21 doses/week for women and men, respectively)
* Morbid obesity (BMI\>35kg/m2)
* Pregnancy
* Pharmacological treatments that interfere with glucose control.
Citicholine-Amantadine Trial in Traumatic Brain Injury

This randomized study aims at comparing between the effects of amantadine, citcholine and its combinations on arousal and behavioral consequences in early phase of moderate Traumatic Brain injury (TBI).

As both agents amantadine and citcholine showed considerable effects on neuro-recovery from TBI, The investigators hypothesized that combination therapy of both drugs will have significant effect as it simultaneously will target multiple mechanisms of injury. So, this randomized study aims at comparing between the effects of amantadine, citcholine and their combinations on arousal and behavioral consequences in early phase of moderate TBI

Eligibility Criteria:
Inclusion Criteria:

* Sustained moderate non-penetrating TBI with GCS of 9-12

Exclusion Criteria:

* Patients with mild (GCS \> 12) or severe TBI (GCS \< 9)
* Patients suffering from any central nervous system disability prior to the traumatic brain injury
* Major medical problems as; major cardiovascular disease or heart failure, renal insufficiency (creatinine clearance, less than 60 ml per minute), liver impairment,
* Pregnancy,
* More than one seizure in the previous month,
* Prior treatment with amantadine,
* Allergy to the study drugs.
Timing for Rectal Surgery After Chemoradiotherapy

The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 8 weeks.

Hypothesis: Greater down-staging and tumor regression is observed when surgery is delayed to 12 weeks after completion of chemoradiotherapy compared to 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Eastern Cooperative Oncology Group (ECOG) 0-1,
* American Society of Anesthesiologists' (ASA) score I-III
* Histological confirmation of adenocarcinoma of rectum
* T3 or T4 N0, T any N positive cancer on MRI, without metastasis on CT scan
* Undergoing preoperative radiotherapy/ chemotherapy
* Curative total mesorectal excision intended
* Written informed consent
* Patients undergoing preoperative radiotherapy should not be excluded

Exclusion Criteria:

* Patients with distant metastasis
* T1 or T2, N0 cancer on MRI
* Rectal cancer 12 cm above the dentate line
* Contraindications to MRI
* Patients previously treated of pelvic organ cancer
* Medical or psychiatric conditions that compromise the patients ability to give informed consent
Combined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain

To assess the effectiveness of a combined physical and psychological intervention in reducing pain and improving function in carpal tunnel syndrome patients with nociplastic pain.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 25-65 years
* Both sexes
* Diagnosis of carpal tunnel syndrome based on clinical examination and nerve conduction studies
* Presence of nociplastic pain as determined by the Central Sensitization Inventory (CSI) with a score ≥40
* Positive tinel and phalen sign.

Exclusion Criteria:

* Previous carpal tunnel release surgery
* Other musculoskeletal or neurological disorders affecting the upper extremity
LMA Unique TM & the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children

The purpose of this study is to compare the clinical efficacy of the air-Q ILA-SP with the current standard of care, the LMA Unique in anesthetized non-paralyzed pediatric patients.

The goal for this randomized, non-crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA-SP in pediatric patients. Oropharyngeal leak pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible fiberoptic bronchoscope examination is often employed to assess proper placement of airway devices. We hypothesize that airway leak pressures with the ILA-SP will be superior to the LMA upon initial device placement, and ten minutes after device placement. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. Ease of placement, fiberoptic grade of laryngeal view, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing general anesthesia using a supraglottic airway device
* 3 to 9 years of age
* 20 to 30 kilograms in weight

Exclusion Criteria:

* History of a difficult airway
* Active gastrointestinal reflux
* Active upper respiratory tract infection
Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum

Peyronie's disease is the appearance of a fibrosis plaque on the albuginea of the corpora cavernosa, which produces mechanical traction at the time of erection, inducing a deformation/curvature of the erect penis. The physiopathology is largely unknown.

There is a significant sexual and psychological impact on patients. Historically, the only possible treatment was surgical. The only drug treatment that was FDA approved for this disease was Collagenase from Clostridium Histolyticum marketed under the name Xiapex® until 31/12/2019 by Sobi laboratory. Marketing was stopped on that date for economic reasons and restricted to the US market only.

The investigators propose a retrospective evaluation of the largest French monocentric series of this treatment from the perspective of the sexual and psychological evaluation of patients.


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years old
* Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution
* Angle of penis deformation ≥ 30°

Exclusion criteria:

* Surgery for Peyronie's disease before
* Anticoagulation
Facebook-based Physical Activity Intervention for Young Adult Cancer Survivors: the FITNET Randomized Pilot Study

The purpose of this study is to determine the feasibility and efficacy of a behavioral intervention, delivered through an existing social networking website (Facebook), on physical activity (moderate-intensity minutes per week) among young adult cancer survivors compared to a self-help education condition. For this research study, investigators will conduct a 12-week randomized trial. After a baseline survey, weekly messages, a pedometer, goal-setting tool, physical activity log and discussion prompts will be delivered to the intervention group. Comparison group participants will receive links to websites with self-help education materials. After 12 weeks, a follow-up survey will be given to both groups. Changes in physical activity, quality of life and psychosocial factors will be examined. The investigators hypothesize that those receiving the intervention will have improved physical activity behaviors at 12-week follow-up relative to those in the comparison group.


Eligibility Criteria:
Inclusion Criteria:

* Young adult between ages 21-39 diagnosed with cancer (excluding non-melanoma skin cancer) at age 18 or older
* At least 1 year beyond date of diagnosis with no evidence of progressive disease or second primary cancers
* Completed cancer treatment
* English-speaking and writing
* No pre-existing medical condition(s) or contraindications that preclude adherence to an unsupervised exercise program, including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
* Not adhering to the American Cancer Society's recommendation of at least 150 minutes of moderate-intensity exercise per week (\<150 minutes/week)
* Have access to Internet service and an active Facebook account
* Willing to be randomized
* Have indicated consent by checking "yes" to the online consent form

Exclusion Criteria:

* Non-English speaking
* \< 21 and \> 39 years of age
* Diagnosed with cancer less than one year previously or still in treatment
* Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
Topical Anesthesia for Closed PKP vs Retrobulbar Anesthesia for Open-sky PKP

Penetrating keratoplasty (PKP) is an open-sky surgery that fundamentally has not changed for more than 100 years. Because conventional PKP is associated with the potential for the development of devastating complications such as expulsive suprachoroidal hemorrhage and endophthalmitis, we modified the technique to one that is a closed surgery under topical anesthesia with the anterior chamber maintained to achieve favorable results. Topical anesthesia is an attractive alternative to traditional injection local anesthesia since the potentially serious complications associated with retrobulbar and peribulbar anesthesia can be avoided. The closed PKP procedure with the stable anterior chamber essentially changes the open nature of conventional PKP. The advantages, i.e., decreased surgical risks, postoperative complications, and surgical difficulties, make PKP viable in most complicated cases.


Eligibility Criteria:
Inclusion Criteria:

* active bacterial keratitis, for which ulceration progressed despite maximum antibacterial medication;
* refractory fungal keratitis that did not respond to antifungal agents;
* nonactive HSK, for which corneal opacities with or without new vessels involved the optical zone;
* ocular acid burn and thermal burn with partial limbal deficiency (50% or less) that, after more than half a year of preoperative treatment, showed reepithelialization and less than 2 quadrants limbal neovascularization.

Exclusion Criteria:

* Patients with keratolimbal allograft transplantation, total limbal stem cell deficiency secondary to ocular burns, and other ocular diseases (ie, amblyopia, age-related cataract, glaucoma, macular edema, and mac ular degeneration) were excluded.
Training With Mobile Application in Breast Cancer

Endocrine hormonal therapy (EHT) applied to avoid recurrence and metastasis of the breast cancer has also side effects which do not threaten life; however, it does negatively effects quality of life. The objective of this study was to determine the effects on quality of life of a mobile app-based (e-mobile) education for supportive care of patients with breast cancer receiving adjuvant endocrine hormonal therapy. The data were collected to with face to face and/or telephone interviews at 2 time points: prior to the initiation (T0) and after the completion (T1) of mobile app-based education. Patients were received education via mobile app for 12 weeks during which they were contacted in every 15 days; a mobile app-based (e-mobile) education was provided, including information about breast cancer definition, treatment process, symptoms management, adequate nutrition, regular physical activity and coping with stress. In this process, the control group patients were provided with standard care.

Mobile devices have an increasing role for the patient care and its use in the field of oncology creates promising opportunities for supportive cancer care and patient education. Mobile applications were established for the supportive cancer care but their area of use is limited. Although there are many field specific medical mobile applications, there are few training programs for the benefit of patients. However, these are innovative tools and provide accessibility, individual training and consultancy in order for the patients to be able to cope with side effects of the treatment; thus, improving their quality of life, symptom management and distress.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary breast cancer,
* Non-metastatic,
* Hormone receptor positive (ER positive and/or PR positive)
* For whom adjuvant EHT was implemented at least for three months

Exclusion Criteria:

* Diagnosed with secondary breast cancer,
* Metastatic,
* Hormone receptor negative (ER negative and/or PR negative)
US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors

A retrospective evaluation of soft tissue tumors that have undergone core needle biopsy with US guidance (US-CNB)

The present study is designed to be the first step in the creation of an interdisciplinary platform collecting data on patients and procedures to provide a predictive tool to help physicians in the management of patients affected by a soft tissue lesion.

The primary aim of our work is to evaluate the diagnostic yield of US-CNB. The secondary aim is to exploit all the imaging data conventionally available at a Sarcoma Center before a biopsy on a soft tissue mass, to build a multiparametric model and score of prediction of malignancy, and eventually of biological behavior - grading.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergone US-CNB for soft tissue lesions at the Rizzoli Orthopaedic Institute

Exclusion Criteria:

* Patients whose histological diagnosis is not available
MDR - M/L Taper With Kinectiv Technology Stems and Necks

The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the M/L Taper with Kinectiv Technology Stems and Necks when used for primary or revision total hip arthroplasty (implants) at 1,2,5 and 10-year follow-up\*. ML Taper with Kinectiv Technology has been on the market since 2008, but has insufficient long term clinical data. Therefore, a prospective aspect to the study will be necessary to reach the 10-year time point.

The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the M/L Taper with Kinectiv Technology Stems and Necks when used for primary or revision total hip arthroplasty (implants) at 1,2,5 and 10-year follow-up\*. ML Taper with Kinectiv Technology has been on the market since 2008, but has insufficient long term clinical data. Therefore, a prospective aspect to the study will be necessary to reach the 10-year time point.

The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.

The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).

\*Follow-up with the patient at the 10 year time point will be collected by the site prospectively and the 1, 2 and 5 year time point data will be collected by the sponsor retrospectively from an existing database including ML Taper with Kinectiv Technology patients from a Zimmer Biomet hip registry.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older
* Rheumatoid arthritis
* Osteoarthritis
* Traumatic arthritis
* Polyarthritis
* Collagen disorders
* Avascular necrosis of the femoral head
* Nonunion of previous fractures of the femur
* Acute femoral neck fractures
* Congenital hip dysplasia
* Protrusio acetabuli
* Previously failed endoprostheses
* Patient must be willing and able to sign IRB/EC approved informed consent.

Exclusion Criteria:

* Skeletal immaturity
* Loss of abductor musculature in the affected limb
* Poor bone stock (e.g., steroid-induced metabolic bone disease)
* Poor skin coverage around the hip joint
* Neuromuscular disease (e.g., Charcot's joint) in the affected limb
* Local and/or overt systemic infection
* Patient with a stove-pipe femur
* Stem implanted using cement fixation.
* Off-label use
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* Patient is known to be pregnant or nursing
* Patient is a prisoner
* Patient is a known alcohol or drug abuser
* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent Patient is unwilling to sign the informed consent
SERum-bank for PANcreatic Cancer

This study is about pancreatic cancer. If the diagnostic cancer is done at an early stage (\<2cm), the chances of recovery are very good.

But the main problem is there is not any detections means for this cancer. Sadly, when there is a cancer diagnostic , it's already too late in the majority of cases, because the cancer is in an advanced case.

Today, there is no any effective means of detection... Blood markers can be a simple means of early detection

The purpose of this study is to establish a sero-library in a case-control cohort to assess several potentially useful serum biomarkers, such as adiponectin in the early diagnosis of pancreatic cancer.

Eligibility Criteria:
ADENOCARCINOMA GROUP

Inclusion Criteria:

* Documented adenocarcinoma (cytology / anatomopathology), all stages, except if the tumor is immediately resectable and does not require preoperative cytological evidence. In this case, the inclusion and the first collection of the sero bank is done preoperatively. The diagnostic confirmation will therefore be made post-operatively at the risk of being excluded in the event of a different diagnosis.
* At the start of treatment (before surgery / 1st course of chemotherapy)
* Age ≥ 18 years
* Patient affiliated or entitled to a social security system

Exclusion Criteria:

* Patient refusal
* Acute renal failure
* Child-Pugh B or C cirrhosis
* Patient under guardianship or curators
* Other synchronous cancer or history of cancer \<5 years
* Language barrier

CONTROL GROUP

Inclusion Criteria:

* Age ≥ 40 years
* Patient affiliated or entitled to a social security system
* Digestive endoscopy for any reason other than cancer or chronic inflammatory bowel disease

Exclusion Criteria:

* Patient refusal
* Acute renal failure
* Child-Pugh B or C cirrhosis
* Patient under guardianship or curators
* Other synchronous cancer or history of cancer \<5 years
The Treat-to-target Study of RA Based on Smart System of Disease Management(SSDM)

This study evaluate the Smart System of Disease Management（SSDM）to improve the treat-to-target(T2T) and the safety of drug in the treatment of rheumatoid(RA). All participants will be randomized in the SSDM group and the control group. The patients in the SSDM group will use the SSDM every month and the control group will receive the conventional therapy.

Treat-to-Target (T2T), achieving a DAS28 score lower than 2.6 (remission, Rem) or below 3.2 (low disease activity, LDA), is the main management strategy recommended by ACR and EULAR. The Smart System of Disease Management (SSDM) is an interactive mobile disease management tool, including the doctors' and patients' application system. The patients can perform self-evaluation, including DAS28, morning stiffness duration (MSD) and HAQ, and input medical records (including medication and laboratory test results) through the mobile application. The data synchronizes to the mobiles of authorized rheumatologists through cloud data base and advices could be delivered.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Rheumatoid Arthritis.
2. Have a smartphone
3. Must be able to access disease activity by themselves

Exclusion Criteria:

1. Not able to access disease activity by themselves
2. Lacks the ability of self-management
3. Mental disorders or severe physical dysfunction
4. Extremely poor compliance