cyrilzakka/clinical-trials huggingface dataset:
Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire

Development and validation of a diagnosis questionnaire of parkinsonian primary pain: the "Primary Parkinsonian Pain Diagnostic Questionnaire" (3PDQ)

The aim of this study is to develop and validate a French self-questionnaire to diagnose parkinsonian primary : the "Primary Parkinsonian Pain Diagnostic Questionnaire" (3PDQ). It will allow clinicians to distinguish this pain from the other pain of the parkinsonian patient (whether or not related to Parkinson's disease).

The development and validation of the 3PDQ self-questionnaire will take place in 3 sequential steps:

1. design of the self-questionnaire
2. appearance validity study
3. validation of the self-questionnaire

Participants :

Appearance validity study: 40 painful parkinsonian patients Validation study: 200 painful parkinsonian patients (10 patients per item)

Duration of the study :

Duration of the inclusion period:

* Appearance validity study : 6 months
* Validity study : 20 months

Duration of participation for each patient:

* Appearance validity study : about 30 min
* Validity study : 3 days maximum Total duration of the study: (with results analysis): 3 years

Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson Disease (PD)
* Patients who have chronic pain (for at least 3months) moderate to severe (intensity ≥ 4/10 on visual analogue scale from 0 to 10) specific or unspecific to PD
* Patients who have one type of pain or different type of pain: in this case, patients should suffered from one predominant pain and be able to identify it
* Patients who have stable analgesic medication during the study
* Patients who understand and speak fluently French
* Patients with health insurance
* Patients who signed the written informed consent form

Exclusion Criteria:

* Patients with severe depression according to Diagnostic and Statistical Manual (DSM) V criteria
* Analgesic medication modified recently (less than 1month)
* Patients with psycho-actives substances or alcohol abused
* Patients with cognitive impairment (MoCA score \< 25)
Comparison between2 Drugs in Lupus Nephritis

The aim of this work is to study the effect and side effects of the cyclophosphamide versus mycophenolate in lupus nephritis

Systemic lupus erythematosus (SLE), also known simply as lupus, is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue in many parts of the body.

Symptoms vary between people and may be mild to severe. common symptoms include painful and swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, feeling tired, and a red rash which is most commonly on the face. Often there are periods of illness, called flares, and periods of remission during which there are few symptoms.painless passage of blood or protein in the urine may often be the only presenting sign of kidney involvement.

Acute or chronic renal impairment may develop with lupus nephritis, leading to acute or end-stage kidney failure. Because of early recognition and management of SLE, end-stage renal failure occurs in less than 5% of cases; except in the black population, where the risk is many times.Nephritis is the most severe manifestation of lupus. Between 1950s and 1970s, corticosteroids were used for the treatment of lupus nephritis (LN) ,and using of cyclophosphamide(CPM), improved the outcome dramatically with 5 years survival increasing from 17% to 80%.Subsequently, intravenous (iv) CPM became the standard of care in induction regimes; however, ivCPM was associated with complications such as bladder toxicity, gonadal problems, and infections. To reduce the toxicity, low-dose of 500mg iv(CPM) every two weeks for six months showed equivalent efficacy and less side effect.

Mycophenolatemofetil(MMF) is widely used in solid organ transplantation and it reduces the rate of acute rejection following renal transplantation.

It has also been used to treat patients with other immune-mediated disorders such as immunoglobulin A nephropathy, small-vessel vasculitides and psoriasis .

Lupus nephritisis inflammation of the kidney that is caused by systemic lupus erythematous (SLE). Lupus nephritis happens when lupus involves the kidneys.its symptoms, though, are not always dramatic. for many, the first noticeable symptom is swelling of the legs, ankles and feet. less often, there can be swelling in the face or hands.

Eligibility Criteria:
Inclusion Criteria:

1. All patients have systemic lupus erythromatosis with lupus nephritis either newly diagnosed or with history of SLE with lupus nephrits
2. All stage of lupus nephritis except stage(i,v,vi)
3. patients who accepted to participate in the study.

Exclusion Criteria:

1. Patient with acute inflammatory process such as(rheumatoid arthritis or other rhumatoligical diseases).
2. Patients who are taking other immunosuppressive therapy.
3. Patients with malignancies.
4. Patients with HCV, HBV or HIV infection.
5. Patients with lupus nephritis sage(i,v,vi).
In Patients With Carpal Tunnel Syndrome, Median Nerve Conduction is Evaluated After Moving the Wrist Bones

The goal of this clinical trial is to analyze the immediate effect of manual mobilization techniques of the carpal bones on the median nerve, in patients with carpal tunnel syndrome. The main question it aims to answer is whether there is an immediate positive effect on the electrophysiological variables of the median nerve in patients with carpal tunnel syndrome after performing this technique.

Participants will undergo a carpal bone mobilization technique. There will be a comparison group that will not undergo the technique. The researchers will compare the control and intervention groups to see if the technique has an immediate positive effect.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years
* Present carpal tunnel syndrome diagnosed by electroneurogram
* Have understanding and communication skills
* Give consent to participate in the study.

Exclusion Criteria:

* Having received previous surgery on the hand or wrist
* Present limitation of movement of the carpal bones.
* Not signing the informed consent.
Acute Effects of Wine Consumption on Healthy Volunteers

The purpose of this study is to investigate whether red and white wine consumption has acute effects on postprandial biochemical markers related to platelet aggregation, inflammation and oxidative stress compared to water or 12.5% ethanol aqueous solution consumption.

The last few years, epidemiologic studies indicate that regular moderate consumption of alcohol is associated with lower risk of coronary heart disease and heart attack, as well as with lower mortality. More specific, a J or U-shaped association between alcohol consumption and the incidence of coronary heart disease have been suggested, which means that there was lower disease risk in moderate alcohol consumers than in abstainers or heavy drinkers.

The scientific interest was focused on wine after the term "French paradox" was introduced, in order to describe the epidemiological observation that the French suffer a relatively low incidence of coronary heart disease, despite having a diet relatively rich in saturated fats. The paradox was attributed to the moderate consumption of red wine by French. Even though many clinical studies have occurred since then, only few of them report the postprandial effect of wine, mainly focusing on the study of oxidative stress markers and endothelium dysfunction. Also, a limited number of publications refer to the postprandial wine effect upon platelet aggregation, which is an indicative marker for inflammation / thrombosis and atherosclerosis.

The limited clinical evidence prompted us to investigate the postprandial effect of wine consumption upon platelet aggregation, inflammation and oxidation markers, by undertaking a clinical study of crossover design. The subjects randomly consumed 4ml of drink \[Robola or Cabernet Sauvignon or 12.5% ethanol or water\]/kg of individual, parallel with a standardized meal, which consisted of 30.8% carbohydrates, 12.0% proteins and 53.1% fat. The meal total energy was 787.2 kcal.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* non-obese

Exclusion Criteria:

* smokers
* those who reported slimming or any other dietary regime
* abstainers from alcohol consumption
* heavy drinkers
* athletes
* subjects who were on medication, such as aspirin, that may have an impact on platelet aggregation or surgical events that may have affected the study outcomes
* participants with a known diagnosis of either hypertension or diabetes
* subjects on medication
Management of Pilon Fractures With Versus Without Fibula Fixation

Management of pilon fractures with versus without fibula fixation

Comparing results with or without fibular fixation in :

* Rate of bone union .
* Functional return ( clinical outcomes)
* Alignment of lower limb.

Eligibility Criteria:
Inclusion Criteria:

* patients with metaphyseal non rotational pilon or distal tibia : age ( 18 _ 65 )
* No skin troubles
* No infections
* Non-dibetic patients.

Exclusion Criteria:

* Patients who will not complete their follow up.
* Skin troubles
* Infections
Pharmacoepidemiologic General Research Extension: PGRx-sIBM Study

Sporadic inclusion body myositis (sIBM) is a rare idiopathic inflammatory myopathy characterized by chronic proximal leg and distal arm asymmetric muscle weakness. Its prevalence is estimated between 10 and 100 cases per million, over the age of 50. Little is known about the natural course of the disease, the delay between onset and diagnosis, the patterns of disease management and treatment in routine practice, as well as the burden for patients.

The objectives of the PGRx-sIBM study will be to describe:

* The epidemiology of the disease (estimation of the prevalence, age at onset, delay between onset and diagnosis, diagnosis process, etc.)
* The patterns of disease management and treatment in routine practice
* The burden of the disease for patients and their informal caregiver, as well as the quality of life of patients
* The burden of the disease for informal caregivers

This will be an observational (non-interventional), cross-sectional (transversal) study.

Study setting The PGRx-sIBM will take place in France, Italy, Switzerland and Spain. Recruitment centers will be public and private practices and hospitals from urban or rural areas. In each recruitment center, at least one physician will act as a study investigator, in charge of identifying and recruiting patients.

Inclusion of patients

Patients will be included by their specialized physician (neurologist, Internal Medicine) during a regular outpatient visit, provided that they meet the following inclusion criteria:

* The patient has been diagnosed with sIBM, as per the physician judgement and regardless of the date of diagnosis
* Male or female
* Age ≥ 45 years old
* The patient does regularly live in the country of inclusion
* The patient or his/her proxy can read and respond to a telephone interview
* The patient agrees to participate

Exclusion criteria will be:

* The patient refuses to participate or the written Consent Form is not signed
* The patient or his/her proxy cannot be reached by telephone. All eligible patients will be invited to participate in the study, during a 3 to 6-month period of time.

The target sample size will be of 190 patients (≈15-20 in Switzerland, ≈50 in Spain, ≈50 in Italy and ≈70-75 in France).


Eligibility Criteria:
Inclusion Criteria:

* The patient has been diagnosed with sIBM, as per the physician judgement and regardless of the date of diagnosis
* Male or female
* Age ≥ 45 years old
* The patient does regularly live in the country of inclusion
* The patient or his/her proxy can read and respond to a telephone interview
* The patient agrees to participate

Exclusion Criteria:

* The patient refuses to participate or the written Consent Form is not signed
* The patient or his/her proxy cannot be reached by telephone.
Protected Pea Protein Extract and Satiety Hormone Release

The increasing prevalence of overweight and obesity among the population contributes to increased incidences of chronic metabolic diseases. Healthcare costs related to these diseases are rising; prevention or delay of onset of disorders associated with overweight is needed. Food ingestion exerts a transient suppressive effect on appetite and further food intake by releasing gastrointestinal hormones. Proteins have been shown to be more satiating than carbohydrates and fat. Intraduodenal administration (via a naso-duodenal intubation) of pea protein has been shown to reduce food intake and increase satiety hormone levels in humans, in contrast to orally dosed (unprotected) pea protein. In the present study we aim to investigate the effects of human gastric fluid on the degradability of five different protected pea protein products. Further, in an ex vivo experiment on freshly obtained human duodenum tissue applying Ussing chamber technology; we aim to investigate the intestinal satiety hormone release by the five different prototypes. The prototype that is less degraded by human gastric fluid and is most effective in intestinal satiety hormone release will be used in a future clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men/women
* BMI between 18 and 25 kg/m2
* Consistently stable body weight for at least 6 months (± 2 kg)

Exclusion Criteria:

* Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L);
* Gastroenterological diseases or abdominal surgery (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgment of the principle investigator);
* Cardiovascular diseases, cancer, liver or kidney malfunction, auto-immune diseases, disease with a life expectancy shorter than 5 years;
* Abuse of products; alcohol (\>20 alcoholic consumptions per week) and drugs
* Smoking
* Plans to lose weight or following a hypocaloric diet;
* Use of any medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing;
* Regular use of laxation products;
* Use of antibiotics in the 90 days prior to the start of study.
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 90 days prior to the study
* Known pregnancy, lactation (checked by a pregnancy test before start of study)
* Blood donation within 3 months before study period
* Self-admitted HIV-positive state
Annatto-derived GG for Statin-associated Myopathy

To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.

Statins are widely prescribed cholesterol-lowering oral drugs. The majority of reported adverse effects due to statin include muscle pain, weakness, cramp, and tiredness. CoQ10 supplementation has been widely used to reduce statin-related muscle complaints. Several human studies have been reported with inconsistent effects of CoQ10 on statin-related symptoms. This study is to investigate the role of 3-month annatto-derived geranylgeraniol (GG) in statin-related muscle outcomes in humans. Qualified subjects will be matched by age, gender, and body weight, and then randomly assigned to a no GG group, a low GG dose group, or a high GG dose group. The outcome measures will be assessed at baseline and after 3 months. Muscle-associated measurements will be recorded using subject questionnaires (also follow-up after 3 and 6 months), muscle performance results, and blood samples. We will monitor the safety of subjects after 3 months. Food intake, physical activity, and medication changes will be recorded at baseline and after 3 months. All data will be analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥40 of either sex
* Statin-treated patients with muscle pain alone or accompanied by other symptoms.
* Patients currently receiving a statin who developed new-onset myalgias in within 90 day of initiation or a dosage increase

Exclusion Criteria:

* Malignancy or significant neurological or psychiatric disturbances, including alcohol or drug abuse.
* Woman who is pregnant, breastfeeding, or of childbearing potential and not taking adequate contraceptive precautions.
* Had CoQ10 supplement one month before starting the study.
* Genetic musculoskeletal and neurologic disorder known to affect skeletal muscle metabolism
* Had steroid medication one month before starting the study.
Effect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients

This study evaluates the effect of recombinant human erythropoietin (rHuEPO) on the neovascularization of pediatric moyamoya disease patients. rHuEPO will be administrated during perioperative period of the first revascularization surgery. Primary outcome (Incidence of Good postoperative MCA territory revascularization by cerebral angiography) will be evaluated after 3-6 month of revascularization surgery.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric Moyamoya patients scheduled for the first revascularization surgery

Exclusion Criteria:

* Hypersensitivity or contraindication to rHuEPO
* History of Unstable hypertension, Hypertensive encephalopathy, Thrombosis
* Primary intracerebral hemorrhage (ICH), Subarachnoid hemorrhage (SAH), Arterio-venous malformation (AVM), Cerebral aneurysm, or cerebral neoplasm
* History of seizure
* Hemoglobin \>16 mg/dl
* Prolonged PT (PT \> 15.5 seconds, PT INR \> 1.2) or Prolonged aPTT (\> 40 seconds)
* Thrombocytopenia (platelet count \< 100,000/microL), Thrombocytosis (platelet count \> 400,000/microL), Neutropenia (absolute neutrophil count (ANC) \< 1500/microL)
* Abnormal kidney function (Creatinine\> 2.0 mg/dl, History of dialysis)
* Abnormal hepatic function (aspartate transaminase\> 80 unit/L, alanine aminotransferase\> 80 unit/L)
Validity and Reliability of Arabic Version of Breast Questionnaire

To test validity and reliability of the translated Arabic version of breast questionnaire .

Breast cancer is the second most common cancer among women in the United States, with an estimated 246,660 .

Breast cancer patients and survivors now have many surgical options, which emphasizes the importance of understanding the long-term quality of life (QOL) outcomes Women undergoing surgery for primary breast cancer are increasingly making their own surgical decisions, and are often choosing between breast conserving therapy and mastectomy with or without breast reconstruction Although recent studies suggest breast conserving therapy has a survival benefit patients often turn to satisfaction and QOL outcomes data to help guide the decision - making process .

In the treatment of the special type of breast cancer (STBC), the choice of chemotherapeutic agents is often based on the characteristic features of the histological type .

On the other hand, the surgical strategy is usually determined by the tumor size and presence of lymph node metastasis, and the indication for immediate reconstruction is rarely discussed based on the histological type .

A mastectomy is used to remove all breast tissue if you have breast cancer or are at very high risk of developing it. You may have a mastectomy to remove one breast (unilateral mastectomy) or both breasts (bilateral mastectomy) For those with early-stage breast cancer, there are two optiones a mastectomy and Breast-conserving surgery (lumpectomy), in which only the tumor is removed from the breast, may be another option .

Choosing between a mastectomy and lumpectomy can be difficult. Both procedures are equally effective for preventing a recurrence of breast cancer. But a lumpectomy isn't an option for everyone with breast cancer .

Newer mastectomy techniques can preserve breast skin and allow for a more natural breast appearance following the procedure. This is also known as skin- sparing mastectomy Surgery to restore shape to your breast - called breast reconstruction - may be done at the same time as your mastectomy or during a second operation at a later date .

The BREAST-Q can provide meaningful data that can be used to support quality metrics and evidence-guided surgical practices in oncologic breast and plastic surgery It has been widely used by clinicians and researchers to help patients and surgeons better understand outcomes .

Since BREAST-Q was developed in 2009, it has been widely used by clinicians and researchers to capture information regarding health-related quality of life (HRQoL) and patient satisfaction related to breast surgery .

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent to a mastectomy operation.
* Patients ages between 30 to 60 years.
* All participants able to read and write in Arabic.
* All participants can understand items of the questionnaire.

Exclusion Criteria:

* Patients with mental problems.
* Patient with communication, vision, hearing disorders.
* Patient who doesn't fill the questionnaire till the end.
* Patient who isn't cooperative in filling the questionnaire.
Acute Kidney Injury Standardized Clinical Assessment and Management Plan for Renal Replacement Initiation

This study is of a clinical decision support tool for clinicians taking care of patients with severe acute kidney injury in the intensive care unit. Nephrologists will be given a standardized clinical assessment and management plan (SCAMP), which is a tool to assist clinicians in decision making on the need for renal replacement therapy (Mendu et al., CJASN 2017). In alternating months, nephrologists will be given the SCAMP vs. another simplified form. The goal is to test whether patients whose clinicians are asked to fill out the SCAMP have improved outcomes compared to the control group. The investigators are also collecting information about provider adherence to the SCAMP and deviations from the SCAMP recommendations to understand clinical decision making related to renal replacement.

Background: Acute Kidney Injury (AKI) is common among critically ill patients and is associated with substantial morbidity and mortality. Severe AKI requiring renal replacement therapy (RRT) is associated with in-hospital mortality rates exceeding 40%. The investigators designed and implemented an AKI Standardized Clinical Assessment and Management Plan (SCAMP), a decision-making algorithm to assist front-line nephrologists caring for patients with AKI. The investigators piloted the implementation of the AKI SCAMP in the medical intensive care unit at Brigham and Women's Hospital prospectively over the course of 1-year, and illustrated that patients whose nephrologists adhered to the SCAMP recommendations had lower in-hospital mortality. The investigators have a publication in press in the Clinical Journal of the American Society of Nephrology detailing our findings (Mendu et al. CJASN January 2017).

Aims: The primary aim of this study is to expand the prospective implementation of the AKI SCAMP to multiple intensive care units (ICUs) at Brigham and Women's Hospital in an interrupted time series study (nephrologists will be asked to complete the AKI SCAMP alternate months). The investigators aim to test the hypothesis generated by our pilot study, that the utilization of an AKI SCAMP by providers in a critical care setting can reduce in-hospital mortality. Expanding to multiple ICUs and introducing a time series design will mitigate the limitations of our pilot data, such as a small sample size and confounding by disease severity.

Design: The investigators seek to conduct a prospective interrupted time series study of the implementation of an AKI SCAMP utilized by nephrologists in intensive care units during the time period of 1 year to determine if utilization of the AKI SCAMP reduces in-hospital mortality.

Eligibility Criteria:
Inclusion Criteria:

* Acute kidney injury, followed by nephrology consult service
* Intensive care unit

Exclusion Criteria:

* End stage renal disease
* Renal replacement therapy for advanced chronic kidney disease rather than acute kidney injury.