cyrilzakka/clinical-trials huggingface dataset:
Effects of RR and MT on Patient With Stroke

The purpose of this proposal is 1) to compare the relative effects of the robotic rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will potentially influence the functional outcomes after interventions.

Motor deficit of upper extremity is one of the prominent problems in patients with stroke. Looking for effective and efficient treatments to improve affected UE function is of great importance in the field of rehabilitation. Two emerging movement therapies in stroke rehabilitation are robotic rehabilitation (RR) and mirror therapy (MT). Scientific evidence for comparative effectiveness research of RR versus MT versus CI on functional outcomes (e.g., motor, muscle, sensory, and daily functions) in stroke patients is limited. In addition, studies showed FES induced some improvements in individual movements at the shoulder, elbow, wrist, and fingers or in muscle strength in patients with moderate-to-severe paresis. The combination therapy of the FES and training protocols may increase the benefits of standard rehabilitative treatments and may also facilitate motor learning. However, the combined training effects of the RR and FES on stroke patients have not been well studies in a larger sample yet. Specific objectives of this proposed research are as follows: First, The investigators will compare the efficacy of the RR, MT, and conventional rehabilitation. Secondly, the investigators will compare the efficacy of the RR-FES versus RR-PI on outcome measures. Thirdly, the investigators will identify the clinical predictors that will potentially influence the functional outcomes after interventions.

Eligibility Criteria:
Inclusion Criteria:

* Willing to provide the written informed consent
* More than 6 months onset of unilateral stroke
* An initial 25-56 or 18-50 scores on the UE subtest of the FMA
* Sufficient cognitive ability (Mini Mental State Examination ≧ 24 points)
* Without upper limb fracture within 3 months

Exclusion Criteria:

* Recurrent of stroke or seizure episode during the intervention
* Occurence of serious or continuous pain on affected upper-extremity
* History of other neurological disease or severe orthopaedic condition
Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways

Congenital heart defects are seen in 0,8% of life births. In France this means more than 5000 newborns per year. The south-east region of France is particularly affected as a result of a higher birth rate and consanguinity, when compared to other regions. The majority of congenital heart diseases remain unexplained. Genetic causes are indisputable but remain poorly understood. Genetic research needs the availability of a large-scale DNA collection, guided by a robust phenotypic classification. Such a DNA-bank has been created in Paris (CARREG DNA bank, created by the M3C reference centre for congenital heart diseases). Such a bank is currently unavailable in south-east France. To transport biological specimens from Marseille to Paris would be very expensive. In addition, the whole infrastructure required for correct diagnosis and classification of the congenital heart diseases, for sampling, for storage of the samples and genetic analysis, does exist in our AP-HM hospital and in our AMU research unit. For those reasons it is highly preferable to elaborate such a database and DNA-bank locally. The acronym SEA-HD (South-EAst-Heart-Diseases) would be used to name this DNA-bank


Eligibility Criteria:
Inclusion Criteria:

* Echocardiographic diagnosis of congenital heart defect falling within the classification Houyel and Bonnet
* Necessity of making a blood test regardless of study
* Medical care in the AP-HM Timone Hospital children, medical-surgical unit of pediatric and congenital cardiology, Marseille - These Parent Child

Exclusion Criteria:

* Pregnant women
* Patients or parent / legal guardian (if minor) in physical or mental incapacity to understand or sign the consent
* People in Emergencies
* Persons deprived of freedom
* Persons not beneficiaries of a social security scheme
* Persons in health or social institution
HeartPhone Cancer Survivors Trial 2019

This is a behavioral study that will examine changes in physical activity and vascular health in response to a digital tool (app) that will appear on participant's lock screen of their Android phone. Participants will be asked to use this app for 3 months and to wear a Fitbit device continuously throughout the study. Participants will be asked to complete questionnaires, participate in fitness testing and measures of cardiovascular health at 3 months and 6 months after baseline assessments. The hypothesis is that exposure to the app will lead to increased physical activity volume and improved microvessel function.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Diagnosis of breast cancer, leukemia, or lymphoma \<15 yrs
* Completed chemotherapy with cardiotoxic anthracycline-based agents 1+ year ago
* English-proficiency
* Own \& use smartphone with Android operating system

Main Study and Ancillary Study Exclusion Criteria:

* Currently receiving curative treatment for cancer
* 90+ min/week moderate (or greater) intensity PA
* Any medical contraindications on the Physical Activity Readiness Questionnaire
* Require an assistive device for mobility or has any other condition that may limit or prevent participation in moderate-intensity physical activity
* Current smoker
* Pregnant or planning to become pregnant in the next 6 mos/breastfeeding
* Allergy to test substances
* Allergy to latex

Ancillary Study:

* Taking metformin
* Current medications that could conceivably alter the cardiovascular or thermoregulatory control or responses (e.g. beta blockers, calcium channel blockers, angiotensin receptor blockers)
Pilot Medical Evaluation of the T50 Test

This pilot study aims to evaluate in an exploratory way the predictive power of a novel in vitro test (T50 Calcification Inhibition Test, T50 CIT), which measures the mineralization inhibition capacity of blood, in terms of its association with time to all-cause mortality in haemodialysis patients.

Disturbances in mineral and bone metabolism centrally contribute to the exceedingly elevated risk for cardiovascular (CV) disease in dialysis patients. A novel in vitro test (T50 Calcification Inhibition Test, T50 CIT) has been developed, which measures the mineralization inhibition capacity of blood. This pilot study aims to exploratory examine the predictive power of baseline T50 CIT and fetuin-A (protein which is centrally involved in the inhibition of the formation of crystalline hydroxyapatite) values in terms of their association with all-cause mortality in an unselected cohort of haemodialysis patients. Moreover, the study shall investigate the association between baseline T50 CIT and fetuin-A values with CV related mortality, all-cause hospitalization and CV related hospitalization. Finally, the study aims to compare the predictive power of T50 CIT values with a set of six established calcification-related parameters (albumin, phosphate, calcium, magnesium, bicarbonate and fetuin-A). After baseline blood sampling the patients will be followed for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated by study patient and investigator/authorised physician
* Minimum age of 18 years
* Incident and prevalent haemodialysis patients
* Three haemodialysis treatments per week

Exclusion Criteria:

* Any condition which could interfere with the patient's ability to comply with the study
* Pregnancy (pregnancy test will be conducted with female patients aged \<= 55 years) or lactation period
* Participation in an interventional clinical study during the preceding 30 days
Educational Technology to Enhance Diabetes Care - Retention Study

This study mapped the time course of forgetting among resident physicians after they use an online learning exercise covering principles of diabetes care. Participants took a pre-test followed by an online tutorial covering aspects of diabetes care. They then completed a post-test on the same topics after a randomly-assigned time delay from 0 to 55 days. We hypothesized that post-test scores after these different time delays would decline following a curvilinear relationship with increasing time. This understanding of forgetting will inform our selection of a time for delivering reinforcement exercises in future educational studies among physicians.


Eligibility Criteria:
Inclusion Criteria:

* Family medicine residents (physicians in training)
* Internal medicine residents (physicians in training)
Study of Perifosine + Capecitabine for Colon Cancer Patients

This is a Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer.

This study is a Phase I trial. A total of 3 - 9 patients will be enrolled. Three patients will initially be enrolled. There will be no dose escalation in this study as only one dose for perifosine (50 mg) in combination with one dose of capecitabine (1000 mg/m2 BID) will be evaluated. The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced DLT attributable to the study drug(s), when at least six patients have been treated at that dose and are evaluable for toxicity. Pharmacokinetic (PK) data will also be evaluated from all enrolled patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with 3rd line or \> metastatic colon cancer
* Patients must have received or not be candidates for regimens containing 5- FU, oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab
* No prior exposure to perifosine
* Adequate bone marrow, liver, and renal function
* Patients must have at least one measurable lesion
* Patients must agree to have extra blood drawn for PK analyses

Exclusion Criteria:

* Patients with prior exposure to perifosine.
* Patients receiving any other investigational agents or devices.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
* Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU.
* Patients with known central nervous system CNS metastases.
* Patients with known HIV, Hepatitis B, or Hepatitis C seropositivity.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
* Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Association class II-IV congestive heart failure.
* Female patients who are pregnant or lactating are ineligible.
Efficacy of Hyperthermic Intraperitoneal Chemotherapy

A dose titration study and a combined superiority registry-based open-label randomized control trial is planned to answer the trial objectives. The study will be registry-based to allow simpler and more comprehensive follow-up. Patients with colorectal cancer will be treated with cytoreductive surgery (CRS) together with either standard oxaliplatin HIPEC (the control for the efficacy study) or oxaliplatin/irinotecan HIPEC in combination with 5-FU 24-hour EPIC. The 5-FU will be administered postoperatively when the abdomen is completely sutured. The drug is divided equally into 2 injections of 200 ml each and injected through two abdominal drains that are clamped for 16 hours.

For dose escalation, the titration groups (á 3 or 6 patients) are followed for 30 days postoperatively after which the Data Monitoring Committee (DMC) will determine whether or not to increase the 5-FU dose for the following group of patients.

To study efficacy, randomization is performed intraoperatively. The patient is followed up postoperatively for a total of 3 years for the secondary endpoints which may be extended by the study committee to 5 years. Since the trial is registry based, the long-term follow-up does not require separate eCRF evaluations. These evaluations can be automatically retrieved from the registry - both recurrence data, quality of life, and morbidity data. Some specific eCRF evaluations will be integrated as a separate study part of the HIPEC registry, such as inclusion/exclusion criteria and adverse event reporting (including SUSAR reporting).

Not detailed description entered.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent prior to any study specific procedures.
* ECOG Performance Status Score 0,1 or 2
* Adequate kidney, liver, bone marrow function according to laboratory tests
* For females of childbearing potential, a negative pregnancy test must be documented
* ≥ 18 years old and \<75 years old
* Colorectal cancer with peritoneal metastases
* All patients deemed eligible for CRS and HIPEC according to clinical routine management during a HIPEC multidisciplinary board at each respective hospital can be included.

Exclusion Criteria:

* Previous severe toxicity/allergic reactions to systemic chemotherapy agents oxaliplatin or irinotecan or 5-fluorouracil
* Unable to tolerate intensified HIPEC treatment due to comorbidity
* Metastasis other than peritoneum
* Pregnant or lactating (nursing) women
* Active infections requiring antibiotics
* Active liver disease with positive serology for active hepatitis B, C, or known HIV
* Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to and up to 4 weeks after study treatment
* Incomplete cytoreduction defined as completeness of cytoreduction score 1-3
* Histopathology of other origin than colorectal cancer
Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* （1）Age ≥18 years old, no gender limit ;
* （2）be diagnosed with AML (non-M3) according to WHO 2016 standards;
* （3）No previous treatment;
* （4）Ineligible for intensive chemotherapy based on the following definitions: ≥75 years of age or 18 to 74 years of age with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3 A history of cardiac disease such as congestive heart failure Treatment is required, or ejection fraction ≤ 50%, or chronic stable angina, diffusing capacity of lung for carbon monoxide (DLCO) ≤ 65%, or forced expiratory volume in first second (FEV1) ≤ 65%, creatinine clearance ≥ 30 mL/min to \< 45 mL/min, moderate hepatic impairment, total bilirubin \> 1.5 to ≤ 3.0 × ULN, other comorbidities that are not suitable for intensive chemotherapy in the physician's judgment.
* （5）Subjects must have an ECOG performance status score of: 0 to 2 for subjects aged ≥ 75 years or 0 to 3 for subjects aged ≥ 18 to 74 years.
* （6）Other comorbidities that are not suitable for intensive chemotherapy in the doctor's judgment;
* （7）Expected survival time ≥3 months;
* （8）Have the ability to understand and be willing to sign the informed consent form for this study.

Exclusion Criteria:

* (1) Combined with other malignant tumors
* (2) Have ever received treatment with chidamide and / or venetoclax or azacitidine;
* (3) The risk is assessed as low risk according to the NCCN 2022 guidelines \[t(8;21)(q22;q22.1);RUNX1-RUNX1T1, inv(16)(p13.1q22) or t(16;16 )(p13.1;q22);CBFB-MYH11 \] ;
* (4) The subject is known to have AML central nervous system (CNS) infiltration;
* (5) Have undergone cardiac angioplasty or stent placement within 12 months before signing the informed consent form , or have a history of myocardial infarction, unstable angina, or other clinically significant heart disease;
* (6 ) Active infections (including bacterial, fungal or viral infections) and organ bleeding that cannot be controlled clinically;
* (7) Pregnant or lactating women;
* (8) Participated in any other clinical research within 3 months before signing the informed consent form ;
* (9 ) The researcher believes that it is not suitable to participate in this study;
Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease

The purpose of this study is to investigate the effect of weight loss rate on liver steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and after bariatric surgery. The investigators also aim to study the short-term effect of bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* 20≤ age ≤80
* BMI\>35kg/m2
* Men and women
* Fatty infiltration in liver ultrasonography

Exclusion Criteria:

* Alcohol drinking \> 140g/week
* Presence of hepatitis B or C or HIV
* Known liver disease such as:

  1. Wilson's disease
  2. hemochromatosis
  3. α1-antitrypsin deficiency
  4. autoimmune liver disease
  5. primary biliary cirrhosis
  6. primary sclerosing cholangitis)
Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With PBC in Women

Fatigue is a clinical symptom that has been described as the most disturbing by around 50% of patients with PBC. It has an important impact on patients' quality of life and is associated with an increased mortality risk. To treat fatigue in PBC, only medical treatments have been tested with limited efficacy or serious sides' effects. In other diseases, mostly cancer, psychological interventions showed efficacy on fatigue decrease. Most interventions consist in psychoeducation with: education about fatigue, development of self-care or coping techniques, activity management and learning to balance between activities and rest. Hypnosis, which consists in a body work for psycho-therapeutic use (e.g., through imagination), has also shown promising results. Moreover, psychological intervention efficacy seems to be influenced by patients' characteristics, such as personality. Therefore, the first aim of the present single-center randomized controlled phase 2 trial is to assess the efficacy of a psycho educational intervention and a hypnosis intervention on PBC patients' fatigue to demonstrate that both psychoeducational and hypnosis interventions decrease patient fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Women from 18 to 75 years old,
* Diagnosis of primary biliary cholangitis (PBC) according to recognized criteria (EASL 2017),
* Medically stable under treatment with UDCA initiated for at least 6 months, ie medically stable on the basis of liver biological parameters (no increase of more than 20% in bilirubin, ALP and transaminases) and absence of disabling pruritus (permanent and EVA\> 6/10 or scratching lesions),
* Presenting a significant level of fatigue (fatigue score on PBC-40\>= 33),
* Understanding the French language,
* Availability and ability of the patient to access an internet network terminal to answer the online questionnaires of the study,
* Signed consent form.

Exclusion Criteria:

* Presence of cirrhosis with a Child-Pugh B or C,
* Presence of disabling pruritus (permanent, or EVA\>= 7/10 in the last 3 weeks, or objectivable scratching skin lesions),
* Patient on liver transplantation waiting list or total bilirubin\> 50 μmol / L (3 mg / dL), or recent complication (\<6 months) of cirrhosis (ascites, hepatic encephalopathy, rupture bleeding) of esophageal varices),
* Untreated depressive disorder,
* Any comorbidity not medically controlled (i.e. all dosage changes \<3 months due to a control of the associated pathology deemed insufficient by the referring physician) or life-threatening in the medium term (within 2 years).
* Psychiatric disorder modifying the relationship to the reality
Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry

The purpose of this study is to document stent functionality and practice patterns in Canada pertaining to indications for use and stent type selection for self-expanding biliary metal stents (SEMS) when used per standard of practice.

This study is designed to provide a report of these features related to the use of WallFlex metal biliary stents used per standard of practice in Canada.

Eligibility Criteria:
Inclusion Criteria:

* Subject indicated for biliary metal stent placement per local standard of practice
* Age 18 or older
* Willing and able to comply with study procedures and follow-up schedule
* Willing and able to provide written informed consent to participate in study

Exclusion Criteria:

* Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
* Subjects who the investigator deems at risk for device or procedure related complications per the Directions for Use (DFU)
Registry Study of ID & IDA in Korean Patients With Heart Failure

The prevalence of Iron Deficiency and Iron Deficiency Anemia in Korean HF patient

Epidemiological study to assess The prevalence of ID (Iron Deficiency) \& IDA (Iron Deficiency Anemia) in Korean patients with heart failure

Eligibility Criteria:
Inclusion Criteria:

* more than 19 years old
* Informed Consent Form
* Hear Failure criteria as belows

  * Heart Failure Sign(more than 1 Sx such as fatigue, dyspnea, ankle swelling)

    * Heart Failure Symptom(more than 1 among Jugular venous pressure (JVP) elevation, pulmonary crackle, peripheral edema) ③ Lung congestion or edema at chest X-ray ④ Objective findings of structural or functional cardiac abnormality(more than abnormality level of BNP or NT-proBNP, abnormality of echocardiography )

Exclusion Criteria:

* Not applicable
Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse

Introduction With increasing age the incidence of pelvic organ prolapse (POP) rises and will increase substantially in the future according to forecasting studies. It is possible that oestrogens, alone or in combination with other forms of therapy, may assist in the management of POP by increasing collagen synthesis and thereby improving the strength of the weakened vaginal epithelium. Yet, studies investigating the effect of topical oestrogen and its impact on POP associated symptoms, both self-reported improvement and observations of objective improvement, are lacking.

Objective To evaluate the subjective efficacy concerning prolapse associated complaints measured by the German pelvic floor questionnaire (domain POP: POP-score) after preoperative use of local oestrogen compared to preoperative placebo treatment in postmenopausal women with symptomatic pelvic organ prolapse. Further variables of interest are POP-score after 3 months, differences regarding the objective prolapse quantification system (POP-Q), surgical outcome and tissue operability assessed by the surgeon.

Methods In this prospective, randomized, double-blind, placebo-controlled, multicenter study the investigators aim to include 120 postmenopausal women with symptomatic pelvic organ prolapse and indicated operative procedure. An analysis of covariance will be computed with the depending variable POP-score after 6 weeks and the independent variables group (verum versus placebo) and Pop-Score at baseline.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Able to read, understand and sign informed consent
* Able to apply a vaginal cream
* Symptomatic pelvic organ prolapse with planned and indicated prolapse surgical repair

Exclusion Criteria:

* Suspicion or history of breast cancer or other oestrogen responsive malignancies (endometrial cancer)
* unexplained abnormal vaginal bleeding
* history of deep vein thrombosis
* inherited or acquired blood clotting disorders (eg, APC resistance, Antithrombin III deficiency)
* transient ischaemic attack, myo- cardial infarction or ischaemic heart disease
* Hypersensitivity to oestrogen
* Unable to read and sign informed consent