cyrilzakka/clinical-trials huggingface dataset:
Interest of a Hybrid Connected Watch for Cardiac Rhythm Monitoring in Post-operative Cardiac Surgery

The objective of this single-center pilot study is, with the help of a connected watch, to show the absence of recurrence or maintenance of sinus rhythm in patients with a Post Operative Atrial Fibrillation (POAF) and to help treating cardiologists in the care of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Major with an indication for conventional cardiac surgery with de novo postoperative AF onset.
* Agreeing to participate in the study and having signed an informed consent.
* Agreeing to undergo 12 months of postoperative monitoring.

Exclusion Criteria:

* Patient with pre-operative AF
* Patient who does not have a smartphone compatible with the connected watch.
* Patient unable to perform an ECG measurement independently.
* Patient with a physical constraint to the measurement (arteriovenous fistula...)
* Minors
* Pregnant or breast-feeding women
* Adults under guardianship, under curatorship
* Patients whose life expectancy is less than 1 year
* Patients participating in another therapeutic trial likely to impact the evaluation criteria of the MONHYCARD study
* Contraindication to long-term anticoagulants
* Patients implanted with a mechanical valve prosthesis pre-operatively or after surgery
Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications

The purpose of this study is to assess the safety of autologous Adipose-Derived Mesenchymal Stem Cell for use in End-Stage Liver Disease patients undergoing the creation of a duct-to-duct anastomosis during Living Donor Liver Transplantation.


Eligibility Criteria:
Inclusion Criteria

* Listed for liver transplantation
* Non-pediatric patients with a planned LDLT
* Ability to communicate with investigative staff
* Competence to give written informed consent
* Ability to comply with the entire study procedure
* All sexes and genders will be eligible for the study

Exclusion Criteria

* Planned deceased donor liver transplantation
* Uncontrolled / unresolved local or systemic infection
* Body mass index \> 40
* Planned pancreaticoduodenectomy or sleeve gastrectomy
* Anticipation of 3 biliary anastomoses (we will include those anticipated to have 1 or 2 biliary anastomoses as detailed below)
* Pregnancy or breastfeeding
* Non-liver cancers (we will include certain patients with primary liver cancer as detailed below)
* Treatment with any investigational drug / device within 60 days prior to study entry
* Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs
* Patients who are employees or relatives of the investigator
Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure

This is a study to determine the safety and effectiveness of Darbepoetin (Aranesp) given every 14 to 28 days to treat low red blood cells in children with chronic kidney failure.

Erythropoietin (EPO) is a glycoprotein synthesized in the kidneys which regulates the rate of proliferation and differentiation of red blood cell precursors. The main cause of anemia in children with chronic renal failure is deficiency of EPO production as a result of declining renal function. Recombinant human EPO (rHuEPO) is a synthetic erythropoietin that is structurally and functionally similar to naturally occuring EPO. Treatment of anemia using rHuEPO has been associated with an improvement in the quality of life for patients, likely attributable to an increased production in hemoglobin and a reduction of dilatation of the heart. Recently, an analogue of EPO with two extra oligosaccharide chins, darbepoetin alfa, has been described as having a more prolonged effect requiring less frequent dosing.

There are currently no data available on the efficacy of darbepoetin alfa administered every 14-28 days for children. The most common dosing schedules in the clinical trial at HSC are every 7, 10, and 14 days. Due to reports of increased pain associated with the SC injection, and confusion of caregivers when the 10 day dosing schedule is necessary, the goals of the current proposal are to: 1) Decrease the frequency of SC injections and 2)Eliminate the 10 day dosing schedule for the administration of Darbepoetin.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic renal insufficiency or end stage renal disease (ESRD) requiring dialysis
* clinically stable
* hemoglobin of 110-125 g/L in screening period; for naive subjects, hemoglobin \< 110 g/L
* not iron deficient (TSAT \> 19.5%) within 4 weeks of study entry
* stable darbepoetin alpha therapy administered IV or SC q7 to q21 days OR darbepoetin alpha naive
* written informed consent from parent/legal guardian
* less than 18 years old
* weight at least 10 kg
* females of childbearing potential must practice adequate contraception
* availability for follow-up assessments

Exclusion Criteria:

* scheduled for a living donor kidney transplant within 12 weeks of signing consent
* uncontrolled blood pressure as judged by principal investigator
* change in seizure pattern in past 30 days; grand-mal seizure 12 weeks before enrollment
* current clinical evidence of severe hyperparathyroidism
* major surgery 2 weeks before signing consent
* active inflammatory disease or condition requiring immunosuppressive therapy
* currently receiving antibiotics for active systemic infection
* peritoneal dialysis patient with an episode of peritonitis within the past 30 days
* known HIV antibody positivity
* known antibodies to rHuEPO
* known aluminum toxicity
* known red cell aplasia
* known malignancy
Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy

The aim of this study is to evaluate modulation of anti-tumor T cell responses in cancer patients treated by concomitant radiochemotherapy (i-RTCT)


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed NSCLC (Non Small Cell Lung Cancer) or SCLC (small cell lung cancer) OR histologically confirmed Head and neck cancer
* Patient candidate to a first-line concomitant radiochemotherapy
* Written informed consent

Exclusion Criteria:

* Sequential radiochemotherapy, exclusive radiotherapy, or stereotactic radiotherapy
* History of adjuvant radiochemotherapy for cancer treatment
* Patients under immunotherapy, chemotherapy or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
* HIV, hepatitis C or B virus
* Patients with any medical or psychiatric condition or disease,
* Patients under guardianship, curatorship or under the protection of justice.
Single-center Study Evaluating the Safety and Efficacy of Viscogel® as Adjuvant in Act-HIB® Vaccine

The purpose of this study is to show that ViscoGel® is safe when administrated alone and as an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the quantitative and qualitative effect on the immune response.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have signed a written informed consent consistent with ICH GCP guidelines and local legislations prior to participation in the trial.
* Subjects who are healthy and with no relevant medical history as determined by the investigator.
* Subject that has not previously been known to be infected with or vaccinated against HIB, or exposed to patients diseased with HIB within a 4 months period prior to screening.
* Male and non-lactating female subjects 22-50 years of age.
* Two negative pregnancy tests if female (at screening and day 0)
* Contraceptive use if female i.e. using a highly effective contraceptive method (implants, injectables, combined oral contraceptives, intra-uterine devices \[including hormonal intra-uterine devices\], sexual abstinence or vasectomised partner) for at least one month before dosing and willing to use it for at least one month after dosing.
* Able to read and write Swedish.

Exclusion Criteria:

* Known allergy to any component in Act-HIB, or who have had a serious reaction after previous administration of a vaccine.
* Fever or acute disease including fever.
* Receipt of immunoglobulins or blood products within three months prior to screening.
* Donation of blood or suffered of blood loss of 450 ml within 3 months (4 months if female) prior to screening.
* Donation of plasma within 14 days prior to screening.
* Participation in other clinical study within 3 months prior to screening or previously dosed in this study.
* Known or suspected immunodeficiency.
* Vaccination received within a 2 months period prior to screening.
* Any condition where regular use of inhaled, topical or oral corticosteroid is used.
* Any condition where use of immunosuppressant is needed, e.g rheumatoid arthitis, cancer, transplantation, or treatment with immunomodulators, e.g. anti-TNF alpha, methotrexte, thioguanine, cyclophosphamide, cyclosporine, tacrolimus.
* Smoker or user of other nicotine products at the discretion of the investigator.
* Drug or alcohol abuse or history of drug or alcohol abuse in the past 5 years prior to screening.
* Any medical condition or other circumstances that in the opinion of the investigator might interfere with the study.
* Abnormal clinically significant laboratory values, ECG findings, vital signs or physical examination findings as judged by the investigator.
* Inability to adhere to the protocol including plans to move from the area.
* Use of any prohibited medication (including dietary supplements and herbal medication) within 2 weeks or 7 half-lives (whichever is longer) of day 0.
* Any positive result at screening for serum hepatitis B surface antigen (HBsAG), hepatitis C antibody (anti-HCV) or human immunodeficiency virus (HIV) I and II.
Effects of a Lifestyle Intervention on Body Mass Index in Patients With Bipolar Disorder

Patients with bipolar disorder are at increased risk of weight gain, which in turn, increases the risk for somatic disease and non-adherence to maintenance therapy. Therefore, interventions addressing weight gain are expedient for the management of this disorder. The investigators set out to evaluate the effects of a lifestyle intervention on body mass index, cardiovascular, glycemic and metabolic parameters in patients with bipolar disorder under mood stabilizing pharmacological treatment. 50 outpatients with bipolar disorder under mood stabilizing treatment participated in a randomized controlled trial (waiting control group N=24 and multimodal lifestyle intervention N=26). Each experimental group consisted of two cohorts. The intervention lasted five months and consisted of eleven group sessions and weekly fitness training. Body Mass Index (BMI), body weight as well as cardiovascular, glycemic and metabolic parameters were determined as baseline (March and September 2005) and after five (July 2005 and January 2006) and eleven months (January and July 2006).


Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 70 years of age were considered for inclusion if they:

  1. fulfilled the diagnostic criteria for bipolar disorder according to DSM-IV-TR,27;
  2. were on treatment with medication for at least three months with one of the following substances: lithium, valproic acid carbamazepine, oxcarbazepine, olanzapine, quetiapine, risperidone, amisulpride; and
  3. were not underweight (BMI \> 20 kg/m2).

Exclusion Criteria:

* Pregnancy
* Actual breast feeding
* A diagnosis of anorexia nervosa or bulimia nervosa
* Diabetes type I or II or another serious physical disease
* Use of substances that reduce weight (e.g., topiramate, lamotrigine as mood stabilizer in monotherapy)
* Participants with comorbidity of acute psychosis, drug addiction, personality disorder, suicidal tendencies or a current severe manic or depressive episode were excluded only if attending the program was not possible due to the respective disorder
Observational Trial of Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in CLL/SLL and FL

This study will assess whether there are differences in effectiveness and safety outcomes among PI3K-treated patients in a real world registry, compared to patients treated in clinical trials.

Phase IV, multicenter, prospective observational study in a real world (RW) setting, designed to observe the utilization and effectiveness of PI3K-inhibitor treatment, and HRQoL of patients with CLL/SLL/FL outside the context of a clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Clinical or pathological diagnosis of CLL/SLL according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) diagnosis guideline or pathological diagnosis of FL, for whom the Investigator has decided that PI3K-inhibitor treatment is the appropriate therapy

  * Patients previously treated with PI3K-inhibitors are eligible for this study if they:

    * Are restarting treatment with PI3K-inhibitor at enrollment, or
    * Restarted PI3K-inhibitor treatment within 3 treatment cycles prior to enrollment
  * Patients newly treated with PI3K-inhibitors are eligible for this study if they:

    * Are starting treatment with PI3K-inhibitors at enrollment, or
    * Started on PI3K-inhibitor treatment within 3 treatment cycles prior to enrollment
* ≥18 years of age at time consent is provided to participate in this study
* For patients treated with PI3K-inhibitors prior to enrollment in the study, availability of documentation of previous PI3K-inhibitor treatment, including the start date of previous or current PI3K-inhibitor treatment in patient charts or medical records
* Patient is willing and able to provide a signed and dated Institutional Review Board (IRB)-approved informed consent form (ICF)

Exclusion Criteria:

* Not applicable
DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis

A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis

This is a prospective, multi-center, randomized controlled, open-label, noninferior study to evaluate achievement of optimal PTA dilatation. A total of 188 patients will be enrolled from 14 sites in China. All patients enrolled will be assigned to the test group (DKutting LL balloon, n=94) and the control group (Chocolate balloon, n=94) with randomized allocation ratio of 1:1.

Primary endpoint is percentage of PTA cases in which \<30% diameter stenosis without a flow limiting dissection is achieved. A 30-day after procedure follow-up will be conducted for all 188 patients.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 year-old male \& non-pregnant female
* Patients with Arteriosclerosis Obliterans of Lower Extremities, including stenosis or osculation in femoropopliteal artery.
* Rutherford clinical category-Becker class: 2 to 5
* Patients understand the purpose of the study, will voluntarily participate in the study and sign informed consent. Patients are willing to undergo clinical follow-up as required by this study.
* Digital subtraction angiography (DSA) shows femoropopliteal artery stenosis above 70%, appropriate for treatment with balloon angioplasty
* Reference vessel diameter from 2.5 to 7mm; Total length of lesion is less than 200mm; Total length of osculation lesion is less than 100mm
* Only one target lesion needs to be Treated. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician. The number non-target lesions are limited to maximum 3.

Exclusion Criteria:

* Acute or sub-acute thrombosis exist in target lesion
* Severe calcified lesion (PACSS Grading 4)
* Guidewire cannot cross target lesion
* Amputation planned within 30 days
* In-stent restenosis
* Flow-limiting dissection (NHLBI grading: D-F) occurred in target lesion by pre-dilation
* No other lumen-reduction devices (such as: cutting balloon, dual-wire balloon, Hawk, ELCA etc.) are treated before or after test/control group treatment.
* Before test/control group treatment, target lesion was expanded by Antegrade Dissection Re-entry (ADR) technique.
* Patient who cannot accept anticoagulant or antiplatelet therapy
* Aware of patient allergic to heparin, contrast, aspirin and clopidogrel, anesthetics
* Patients who have not completed clinical trials of other drugs or devices
* Patients with poor compliance and unable to complete the study, which is identified by investigator.
Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab

Purpose:

To evaluate the efficacy when administering steroid combined with single dose rituximab to eliminate the antibody in acquired hemophilia A patients compared to treatment using steroid with cyclophosphamide.

The study will test the hypothesis that steroid combined with small dose rituximab is as effective as steroid combined with cyclophosphamide for FVIII inhibitor eradication in Chinese patients with acquired hemophilia A.

Study design Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment

This is a prospective randomized multi-center controlled pilot trial comparing the regimen of steroid with rituximab and steroid with cyclophosphamide to eradicate anti-factor VIII antibodies in Chinese patients with acquired hemophilia A.

Patients will be randomized to two regimens: methylprednisolone 0.8mg/kg/day (or equivalent corticosteroid doses) for 3 weeks (then tapering gradually,8 weeks in total) with rituximab (375mg/m2 for one dose) or methylprednisolone 0.8mg/kg/day (or equivalent corticosteroid doses) for 3 weeks (then tapering gradually,8 weeks in total) with cyclophosphamide 2mg/kg/day until inhibitor negative(no longer than five weeks).

Patients will be randomized to the treatment cohorts according to the biostatistical methods.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Men or women
* Women post-menopausal or with ongoing contraception
* Diagnosis of acquired hemophilia A
* Patient must be insured
* Patient has provided written informed consent prior to enrollment
* Patient compliant

Exclusion Criteria:

* Congenital hemophilia
* Ongoing treatment with prednisone \> 20mg/d （or equivalent corticosteroid doses） more than 1 month
* Ongoing treatment with prednisone \>0.7mg/kg（or equivalent corticosteroid doses） more than 10 days
* Pregnant and breastfeeding women
* Allergy to steroid
* Immunosuppressive agents treatment within 30 days
* Serum transaminase and bilirubin greater than 1.5 times the upper limit of normal value
* Hepatitis B surface antigen or hepatitis C antibody or HIV antibody (I + II) or syphilis antibody positive
* Patients with diabetes, hypertension, glaucoma, peptic ulcer, herpes zoster, pulmonary infection and so on, who should not be treated with glucocorticoids
* Patients with poor compliance
* Those who can not take contraceptive measures during the test period
* Patient who is considered by the investigator not suitable for clinical study
* Thrombocytopenia
* Leucocytopenia
Mitroflow DL Post Approval Study- North America

Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.

The purpose of this clinical investigation is to evaluate the safety and efficacy of the Mitroflow DL valve when used to replace diseased or dysfunctional native or prosthetic aortic heart valves. The study will be conducted in a minimum of 15 centers in the United States. Patients will be evaluated at each of the following time intervals:preoperative, at implant, in the early postoperative period, at 1 year (between 11 and 13 months postoperatively), and annually for 8 years. The duration of the study is anticipated to be 8 years.

Eligibility Criteria:
Inclusion Criteria:

1. Patients is indicated for Mitroflow DL implantation according to the Instructions for Use (IFU).
2. Patient or patient's legal representative is willing to sign the informed consent.
3. Patient's preoperative evaluation indicated the need for native or prosthetic aortic valve replacement
4. Any patient amenable to aortic valve replacement with a biological prosthesis should be enrolled in the study, even in conjuction with valve repair, coronary artery bypass grafting and other procedures
5. Patient is able to return for all follow-up evaluations for the duration of the study (geographically stable).

Exclusion Criteria:

1. Patient is contra-indicated for Mitroflow DL implantation according to the Instructions for Use.
2. The patient has a pre-existing valve prosthesis in the mitral, pulmonary, or tricsupid position.
3. Patient requires a double or triple valve replacement (repair is not considered an exclusion).
4. Patient has active endocarditis or myocarditis.
5. Patient is pregnant or lactating.
6. Patient is participating in a concomitant research study of an investigational product.
S.P.PRO LIVER POWDER is Used to Improve Liver and Metabolic Indexes in People With Non-alcoholic Fatty Liver Disease

With the Westernization of the diet and insufficient exercise, Taiwan's population of obesity, diabetes, and hyperlipidemia has increased in recent years, and the prevalence of the non-alcoholic fatty liver disease has gradually increased. Although weight loss, dietary adjustments, and certain drug treatments can delay the deterioration of the disease; however, weight loss and dietary adjustment are not easy.

With the Westernization of the diet and insufficient exercise, Taiwan's population of obesity, diabetes, and hyperlipidemia has increased in recent years, and the prevalence of the non-alcoholic fatty liver disease has gradually increased. Although weight loss, dietary adjustments, and certain drug treatments can delay the deterioration of the disease; however, weight loss and dietary adjustment are not easy. Moreover, drugs also have side effects, and there is currently no convenient and effective treatment for people who have non-alcoholic fatty liver disease. The purpose of this trial is that investigating and evaluating the effects on fatty liver, liver fiber, and metabolic indexes after subjects using Shen Pu Yang Gan Wan.

Eligibility Criteria:
Inclusion Criteria:

* Patients with fatty liver diagnosed by abdominal ultrasound or hepatic fibrometer within half a year's data
* Subjects with the non-alcoholic fatty liver disease
* The severity of fatty liver should be at least 3 points by taking an abdominal ultrasound

Exclusion Criteria:

* Female patients are pregnant or breastfeeding.
* Patients with viral hepatitis.
* Long-term drinkers.
* Those who use slimming products and vitamin E.