cyrilzakka/clinical-trials huggingface dataset:
Adaptation Process of Patient-Reported Outcomes, an eVALuation Study

Objectives: To identify the respective contributions of back-translations and of the expert committee in the process of cultural adaptation of patient reported outcome with an experimental design in the adaptation process :

Four translations of a questionnaire will be produced:

* A simple translation by two translators, who serves as the basis for the three other translations
* A translation made with the use of a back-translation.
* A translation with review by an expert committee.
* A translation the use of a back-translation and review by an expert committee.

Properties of each translation will be analyzed and compared


Eligibility Criteria:
Inclusion Criteria:

* Adult (other 18 years)
* Able to read, understand and answer the adapted questionnaire
* Having a medical condition targeted by the questionnaire
Surgical Treatment To Greater Anterior Vaginal Prolapse

A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the anterior vaginal wall prolapse.

Seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair( NAZCA TC™ POP REPAIR SYSTEM) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, length of hospitalization, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not,point (Ba)ics96, below hymenal ring requiring surgical correction were eligible for participation.

Exclusion Criteria:

Patients were excluded if they had:

* Stage 0 or I (ics96) anterior vaginal support
* Declined participation
* Were pregnant or contemplating future pregnancy
* Had prior anterior vaginal prolapse repair with biologic or synthetic graft
* Active or latent systemic infection
* Compromised immune system
* Uncontrolled diabetes mellitus,
* Previous pelvic irradiation or cancer
* Known hypersensitivity to polypropylene.
Stroke, Measurement and Rehabilitation

The main aim of the study was to investigate the effects of transcranial laser stimulation together with neuromuscular electrical stimulation (NMES) in post-stroke patients.

Post-stroke sequelae includes loss functions, such as cognitive and sensory-motor which lead to emotional and social problems, reducing quality of life and well-being. The main aim of the study was to investigate the effects of transcranial laser stimulation together with neuromuscular electrical stimulation (NMES) in post-stroke patients. The clinical trial showed improvement of cognitive function, pain relief, greater manual dexterity, enhancement of physical and social-emotional health which lead to better quality of life and well-being. There was also increased temperature in the treated regions with laser and NMES. Therefore, transcranial laser stimulation associated with NMES can be an important therapeutic resource for rehabilitation after stroke.

Eligibility Criteria:
Inclusion Criteria:

* Female and male aged between 35 and 75 years with hemiplegia after stroke (more than 12 months from onset) as well as those who experienced only one episode of stroke.

Exclusion Criteria:

* Bedridden stroke patients, who had great difficulty standing and walking, psychiatric illnesses, endocrinopathies, heart diseases, severe osteoporosis, cancer, musculoskeletal injuries or disorders in the last six months as well as practitioners of regular physical activity, physical therapy or occupational therapy.
Polysomnographic Findings in Nasal Polyposis

Nasal polyposis (NP) is a chronic inflammatory disease of the nasal and sinus mucosa leading to protrusion of edematous polyps in the nasal cavity. Prevalence of NP among the chronic rhinosinusitis patients is 25-30 %. NP leads to significant limitations in physical, emotional and social aspects of life of the affected patients. Sleep disorder is frequently reported by those patients with impaired nasal breathing. Till now few studies have objectively assessed the impact of NP on sleep quality. the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent endoscopic sinus surgery for recalcitrant nasal polyposis (failure of a 4-month corticosteroid medical treatment) Social insured patient
* Patient willing to comply with all procedures of the study and its duration
* Patient giving consent

Exclusion Criteria:

* Patients with previous nasal surgery for nasal polyposis
* Patients with previous continuous positive airway pressure therapy for obstructive sleep apnea
* Non-coverage by the social security scheme
* Patient unable to receive informed information
* Refusal to sign the consent
* Person deprived of the liberty
* Person benefiting from a system of legal protection (guardianship...)
Deep Brain Stimulation Treatment for Chorea in Huntington's Disease

1. Evaluating therapeutic effects of globus pallidus internus (GPi) deep brain stimulation (DBS) on Huntington's disease (HD) patients with chorea；
2. Explore the relationship between brain network conditions and DBS efficacy in HD patients
3. Explore the effect of different programmed parameters on the treatment of patients with DBS

1. Evaluating therapeutic effects of GPi-DBS on HD patients with chorea: Clinical data of patients at different treatment time points will be collected, using different clinical assessments. The clinical case report form for HD-DBS is consistent with Enroll HD project and the case report form is attached in the appendix. The main purpose is to determine the efficiency of DBS treatment for HD with chorea by comparing the patients' status before and after surgery.

Primary endpoints: Changes in chorea score of UHDRS, changes in total motor score (UHDRS).

Secondary endpoints: changes in cognition will be assessed by stroop interference test, stroop word reading test, stroop colour naming test, trail making test, symbol digit modality test and mini-mental state examination(MMSE); changes in anxiety assessed by Hamilton Anxiety Scale(HAMA); changes in depression assessed by Hamilton depression scale(HAMD) and Beck Depression Inventory (BDI); changes in the frequency and severity of neuropsychiatric symptoms assessed by the Problem Behaviours Assessment for HD and changes in quality-of-life assessed by UHDRS functional assessment and UHDRS total functional capacity assessment.

2 Explore the relationship between brain network conditions and DBS efficacy in HD patients The electrophysiological signals during the operation of HD patients will be collected and analyzed, and compared with the postoperative disease conditions, to determine the relationship between the patient's EEG activity and the mechanism of disease development, disease progression, and treatment effect.

3. Explore the effect of different programmed parameters on the treatment of patients with DBS After the HD patient is turned on, the patient is programmed to adjust the program control parameters of different patients during adjustment, and the effects of different program control parameters on the patient, tolerance, and related side effects are clarified.

Eligibility Criteria:
Inclusion Criteria:

1. Huntington's Disease disgnosis by gene
2. Predominant chorea
3. UHDRS score ≥30
4. Mini-Mental State Examination (MMSE) score meets the education level
5. No plan to change medication within 12 months after randomization
6. Agree to enroll into the clinical trial

Exclusion Criteria:

1. Chorea caused by other diseases
2. Concurrently or previously had other neurological disorders
3. Severe psychiatric disease
4. Unstable condition or severe heart, lung, liver, kidney, or hematopoietic diseases
5. Have a history of cancer unless it has been cured or does not require treatment for the next 5 years
6. Contraindications to an MRI scan
7. Acute psychiatric symptomatology in the last 2 months including suicide ideation, angry or aggressive behaviour, and hallucinations
Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic (ERDFP)

Recently, a multidisciplinary scientific conference proposed to consider iron overload in dialysis patients as pathological only in the event of demonstration of radiological (in MRI), pancreatic or cardiac ferric deposits.

In this context, the aim of the proposed scientific study is to demonstrate the presence of ferric deposits in the pancreas by T2\* MRI in dialysis patients with radiological hepatic iron overload, particularly in cases of moderate and severe iron overload.


Eligibility Criteria:
Inclusion Criteria:

* Male, female, over 18 years old
* Patient on hemodialysis or peritoneal dialysis at the Claude Galien Private Hospital
* Patient on dialysis who has undergone one (or more) abdominal MRI for iron quantification
* Patient who has signed a non-objection form for the retrospective use of their MRI, medical and biological data for the purpose of scientific study

Exclusion Criteria:

* Patient who has signed a form to object to the use of their health data
* Pregnant woman
* Poor adherence to the dialytic technique
* Severe cognitive impairment
* Hepatic cirrhosis
* Frank inflammatory syndrome or an active infectious disease
* Genetic hemochromatosis and transfusion hemosiderosis of hemoglobinopathies and hematological diseases
* Recent major bleeding (\< 3 months)
* Recent major surgery (\< 3 months)
* Transfusion dependence
* Progressive malignant disease
* Pacemakers incompatible with an MRI and metal heart valves
Oregon PrEP at Home Study

This demonstration study will evaluate the real-world implementation of long-acting cabotegravir (CAB-LA) for HIV pre-exposure prevention (PrEP) through a partnership between the OHSU Tele-PrEP Program (TPP) and the OHSU Home Infusion Pharmacy (HIP). The study will perform a formative evaluation of the TPP/HIP partnership to determine its merit and worth, with revisions made as needed to improve the program, which is reflective of a real-world program rollout. The study is observational, and there is no comparison group. The primary objective is to evaluate adherence to CAB-LA by both urban and rural participants using the TPP/HIP partnership. The goals of the study are improve the TPP/HIP program itself with attention to reducing geographic disparities, and to disseminate best practices and lessons learned to the broader HIV prevention community.


Eligibility Criteria:
Inclusion Criteria:

* Residence in Oregon
* English or Spanish spoken and written language ability
* Clinical eligibility for PrEP with CAB-LA including HIV-negative serostatus
* Access to stable Internet
* Access to a clean, safe location that is appropriate for home administration

Exclusion Criteria:

* Clinical ineligibility for PrEP with CAB-LA including HIV-positive serostatus, injection drug use as only HIV risk factor, or clinical contraindication (such as a hypersensitivity reaction to CAB-LA or use of a contraindicated medication).
* Uninsured
* Payer does not cover HIP services
* Pregnancy
* Residence outside of the home infusion program's catchment area
* Incarceration
* Decisional impairment
Fontan Associated Liver Disease

Fontan-associated liver disease (FALD), including the development of cardiac cirrhosis and liver neoplasms (benign and malignant), occurs in a majority of patients with congenital heart disease palliated with the Fontan operation. However, the specific phenotype (fibrosis only, fibrosis + lesions, etc.) of disease and severity/timing of onset are variable. Chronic passive congestion of the liver due to the absence of a functional sub-pulmonary ventricle and resultant chronic central venous hypertension is suspected to be one of the chief drivers of FALD and recent work has demonstrated that ultrasound shear wave elastography can be used to noninvasively detect and measure the degree of liver congestion. Chronic passive congestion of the liver may also be a predictor of other Fontan-related complications, such as protein losing enteropathy, plastic bronchitis, and intractable ascites.


Eligibility Criteria:
Inclusion Criteria:

1. Single ventricle physiology congenital heart disease undergoing Fontan operation;
2. ≤5 years of age at the time of stage 3 Fontan operation;
3. Ability to return for follow-up imaging.

Exclusion Criteria:

1. Inability to undergo ultrasound imaging.
2. Non-English speaking patients, as breath-hold is required for US shear wave elastography in older children due to excursion of the liver with breathing.
Vital Pulp Therapy of Mature Permanent Teeth With Irreversible Pulpitis Using Bioceramic Material

This clinical trial is designed to study and compare the effect of two different types of chelating agents on the vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material.

1. The vital pulps exposed by caries process is treated by complete caries removal followed by full pulpotomy.
2. After hemostasis, application of apple vinegar and EDTA 17% will be used followed by MTA application. finally teeth will be restored with resin composite restoration.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one tooth with carious pulp exposure and irreversible pulpitis.
* Cooperative behavior with no medical problem.
* Absence of tooth mobility , tenderness on percussion.
* History of pain with cold and sweets.
* Radiographically, no internal or external resorption, no periapical or furcation radiolucency and no widening of the periodontal membrane space.

Exclusion Criteria:

* Teeth with pulp necrosis.
* Presence of sinus tract.
* Teeth with open apices.
* Pregnant women.
* History of intolerance of non- steroidal anti inflammatory drugs.
* Tenderness to palpation of adjacent soft tissues
The Effect of Competition Season on Physical Characteristic and Shoulder Periarticular Structures in Swimmers

The aim of this study is to investigate the effect of a competition season on shoulder periarticular structures, muscle strength, muscle endurance, joint range of motion and upper extremity performance in young swimmers.

After being informed about the study, all swimmers giving written informed consent will undergo a 1- week screening period to determine eligibility for study entry. Swimmers who meet the eligibility requirements will be evaluated 3 times: pre-season, mid-season, and post-season.

Eligibility Criteria:
Inclusion Criteria:

* To be between the ages of 10-15
* At least 6 hours of swimming training per week,
* Individuals do not have cooperation and communication problems,
* Individuals volunteer to participate in the study.

Exclusion Criteria:

* Previous upper extremity surgery,
* Experienced upper extremity pain at least 2 times in the past,
* Not attending training regularly for any reason.
Omic Technologies Applied to the Study of B-cell Lymphoma for the Discovery of Diagnostic and Prognosis Biomarkers

The goal of this observational study is to determine the plasma metabolomic profile in diffuse large B-cell lymphoma and high-grade B lymphomas patients before, during and after treatment by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS)

The main question it aims to answer is the correlation between the plasma metabolomic profile of diffuse large B-cell lymphoma and high-grade B lymphomas patients before and after treatment determined by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS) and analysed with MetaboAnalyst web platform to identify specific over- or under-expressed markers.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older;
* Both sexes;
* Patients with confirmed histopathological diagnosis of Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma;
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2;
* Patient intending to receive full-dose treatment (Monoclonal antibodies plus anthracycline based combination chemotherapy);
* Staged with PET-CT or CT.

Exclusion Criteria:

* Patients with comorbidities that may interfere with the interpretation of the results (CKD in dialysis phase, Autoimmune diseases, uncontrolled Diabetes Mellitus (DM), symptomatic Heart Failure (CHF), HIV positive, positive serology for hepatitis B and C);
* Patients requiring multiple blood transfusions (4 or more blood components for the same period or cause);
* Pregnant women;
* First-line treatment in another institution;
* Diffuse transformed Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma
Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy

The aims of the present study is to evaluate the effectiveness of Kinect-based upper limb motor rehabilitation system (ULMTS) program on motor performance and functional outcomes.

The specific aims of this study project will be:

To compare the effectiveness of intervention groups using Kinect-based ULMTS with constraint-induced therapy on motor improvement in children with hemiplegic CP. The investigators hypothesize that motor improvement in using Kinect-based ULMTS will be comparable to constraint-induced therapy.

Eligibility Criteria:
Inclusion criteria are:

1. 3-16 years old
2. diagnosed with congenital hemiplegic or CP with one more affected side
3. considerable nonuse of the affected upper limb.

Exclusion criteria are:

1. no excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon \& Smith, 1987)
2. no severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
3. no injections of botulinum toxin type A or operations on the upper limb within 6 months.
Assessment of Hepatic Fibrosis by Shear Wave Elastography in Patients With Liver Malignancy: A Prospective Single-center Study

To evaluate the diagnostic performance of two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection, using resected tissue pathology as a reference standard.


Eligibility Criteria:
Inclusion Criteria:

* (i) patients with a solid focal liver lesion that was pathologically proven or diagnosed by imaging methods such as conventional US, CT or MR imaging; (ii) patients scheduled to undergo a hepatectomy; (iii) patients with a lesion ≥1.0 cm in diameter.

Exclusion Criteria:

* (i) patients with a history of chemotherapy; (ii) patients unable to properly hold their breath.
A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels

The primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently accepted minimum target level for patients with pre-existing CHD. Secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.


Eligibility Criteria:
Inclusion Criteria:

Men and women age 35-75 who have evident CHD

Exclusion Criteria:

Known hypersensitivity to HMG CO-A reductase therapy, liver disease, evidence of secondary hyperlipidemia
Structuring of a Lung Cancer Screening Program Including Clinical, Radiological and Biological Phenotyping Useful for the Development of Individualized Risk Prediction Tools: PREVALUNG ETOILE

Patients treated at the Hôpital Nord de Marseille for at least one smoking-related pathology (atheroma, chronic bronchitis, non-progressive cancer \> 5 years) or with eligibility criteria for lung cancer screening (inclusion criteria in the NLST or NELSON studies or American recommendations) Interventional study with minimal risks and constraints, with evaluation of lung cancer prevalence; immunological, blood inflammatory and microbiota profile

Determine the maximum clinical, radiological, and biological phenotyping completeness rate following the implementation of a new lung cancer screening care pathway with multidimensional clinical, radiological, and biological phenotyping capabilities


Eligibility Criteria:
Inclusion Criteria:

Age 45- 75 years and

* Medical follow-up for a smoking-related pathology :
* atheroma
* chronic obstructive pulmonary disease / emphysema
* history of non evolving cancer \> 5 years among: ENT, lung, breast, cervical, excreto-urinary cervix, excreto-urinary tract, bladder, esophagus, stomach, pancreas, liver, kidney, chronic myeloid leukemia chronic myeloid leukemia,
* daily smoking for at least 10 years prior to the disease Or

NLST inclusion criteria:

* Age 55 - 74 years
* Cumulative smoking ≥ 30 pack-years
* active or quit for less than 15 years Or

Inclusion criterion in NELSON:

* Age 50-75 years
* Smoking:
* \> 15 cigarettes/D for more than 25 years or
* \> 10 cigarettes /D for more than 30 years
* Active smoking or cessation \< 10 years Or

New American recommendations :

* Age 50 - 80 years
* Smoking ≥20 PA
* Active or weaned \<15 years

Exclusion Criteria:

history of cancer \< 5 years (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma basal cell carcinoma of the skin and prostate cancer with undetectable PSA)

* Symptoms of lung cancer (unintentional weight loss \> 7 kg in 1 year, hemoptysis)
* known history of pulmonary nodule with specialized follow-up
* history of pulmonary fibrosis or pulmonary hypertension
* patient under guardianship or curatorship
* active pulmonary parenchymal infection
* severe cardiac or respiratory insufficiency (rest dyspnea)
* patient not affiliated to the social security system (beneficiary or beneficiary's right)
* Patient deprived of liberty
* Performance status (WHO) 2, 3 or 4
* Pregnant or breastfeeding women
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

The purpose of this this study is to investigate the clinical utility of renal denervation in the treatment of ESRD patients with refractory hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure of 160 mmHg or greater
* On 3 or more antihypertensive medications
* On dialysis for more than 6 months

Exclusion Criteria:

* Renal artery abnormalities
* Known secondary hypertension attributable to a cause other than sleep apnea
* MI, angina, CVA within 6 months
* Others