cyrilzakka/clinical-trials huggingface dataset:
Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease Patients

The goal of this multicentric prospective randomized controlled clinical and economic study is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe form of Parkinson's disease.


Eligibility Criteria:
Inclusion criteria :

* Age\> 18 years and ≤ 80 years
* Akineto-hypertonic and/or tremor forms of Parkinson's disease as defined by the criteria of the French National Consensus conference for Parkinson's disease (March 2000)
* Absence of parkinsonism other than a Parkinson's disease, including absence of one or more of the following signs: autonomic syndrome, hallucinations, pyramidal signs, early postural instability, early cognitive impairment (including apraxia or severe frontal lobe syndrome) (Consensus Conference, March 2000)
* Severe and advanced forms of Parkinson's disease with sensitivity to L-dopa (≥ 40%)
* No contraindication to Duodopa®: hypersensitivity to levodopa and carbidopa, or any of the excipients, angle-closure glaucoma, kidney and liver failures, severe heart failure, severe cardiac arrhythmia, acute stroke, pheochromocytoma, hyperthyroidism, Cushing syndrome, association with non-selective MAOIs and selective MAOIs-A (stop at least 2 weeks before initiation of Duodopa®)
* Fluctuations in motor performance (with OFF time ≥ 2 hours per day) and/or dyskinesia induced by L-DOPA altering significantly the activities of daily life in spite of an optimized treatment
* Hoehn and Yahr score \< 4 in best ON
* Ability to complete a diary of self-evaluation (with the help of another person if necessary)
* MMSE ≥ 24/30
* No evolutive psychosis or history of severe psychosis requiring hospitalization
* No digestive disease or ENT evolutionary
* No concomitant treatment by continuous infusion of apomorphine
* No concomitant treatment by deep brain stimulation
* No serious somatic disease likely to interfere with a good participation to the study, contraindication for gastrostomy
* Menopause proven or woman of childbearing potential with an effective contraception (hormonal / mechanical: oral, injectable, transdermal, implantable, intrauterine device, or surgery: ligation of the fallopian tubes, hysterectomy, total ovariectomy)

Exclusion Criteria:

* Age \<18 and\> 80 years
* No signature of the informed consent form
* Patient with no social insurance or who cannot benefit it through a third person in accordance with the French law on biomedical research
* Population under enhanced protection (i.e minors), pregnant women, breast-feeding women, persons deprived of their liberty by a judicial or administrative decision, people in health and social service, adults under legal protection, and finally patients in emergency situations.
Blood Pressure Lowering Effect of Transcutaneous Electrical Nerve Stimulation

The purpose of this study is to compare the blood pressure reducing property of transcutaneous electrical nerve stimulation with the blood pressure reducing drug felodipin.

Hypertension is a major risk factor for development of several vascular complications and is common world wide. Drug treatment is often necessary to achieve adequate blood pressure reduction but blood pressure control in studied countries is unsatisfactory low. Reasons for failure in treatment are several. Among others reasons intolerable side-effects may prevent successful treatment irrespective of the number of drugs.

Transcutaneous electrical nerve stimulation (TENS) constitutes no risk of interaction with pharmacological agents and previous studies have reported blood pressure reduction.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of hypertension, untreated or currently treated with a maximum of one blood pressure (BP) lowering agent

Exclusion Criteria:

* systolic blood pressure \>170 mmHg and/or diastolic blood pressure of \>105 mmHg
* second- or third-degree atrioventricular block
* current use of opiates or other intoxicants
* neurological disorders (such as Parkinson's disease, multiple sclerosis or peripheral neuropathy)
* need of treatment with TENS, regardless the reason
Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691

To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of PF-04878691.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18-55, inclusive.
* Body Mass Index (BMI) of 18-30 kg/m2; total body weight \>50kg (110lbs).

Exclusion Criteria:

* Pregnant or nursing females.
* Females of child-bearing potential.
* Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic or autoimmune disease or clinical findings at screening.
* Smoking within the previous 6 months.
Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy

A phase 1 prospective study to determine the procedural feasibility and safety and preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in patients with dilated cardiomyopathy.

Five consecutive patients will be enrolled to a phase 1 study to verify the procedural feasibility and safety with the CDC infusion group.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as dilated cardiomyopathy.
* Patients aged under 18 years old.
* Cardiac ejection fraction \< 40%.

Exclusion Criteria:

* Contradiction to cardiac magnetic resonance imaging.
* Cardiogenic shock.
* A patient with unstoppable extracorporeal circulation.
* A patient with lethal, uncontrollable arrhythmia.
* A patient with a complication of coronary artery disease.
* A patient with a complication of brain dysfunction due to circulatory failure.
* A patient with malignant neoplasm.
* A patient with a complication of a serious neurologic disorder.
* A patient with high-grade pulmonary embolism or pulmonary hypertension.
* A patient with high-grade renal failure.
* A patient with multiple organ failure.
* Active infection (including endocarditis).
* Sepsis.
* Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury).
Atogepant in Real Life in Italy (GIANT)

Atogepant is an oral, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist that has been approved for the preventive treatment of episodic and chronic migraine (\>= 4 monthly migraine days) with or without medication overuse.

This study is designed to confirm the effectiveness and safety of atogepant in real life. The primary endpoint is the change from baseline in the mean number of monthly migraine days (MMDs)across the 12 weeks. Secondary endpoints include: change in monthly analgesic intake, Numeric Rating Scale (NRS), Headache Impact Test-6 (HIT-6) and Migraine disability assessment (MIDAS) scores, \>=50%, \>=75%, 100% responders, \>=50%, \>=75%, 100% responders in patients with medication overuse at weeks 9-12 compared to baseline and adverse events eventually occur during 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria: •

Age: \>18 yrs Diagnosis of migraine Migraine frequency: \>=4 monthly migraine days (MMDs)

Exclusion Criteria:

Patients using concomitant migraine prophylaxis Use of onabotulinumtoxinA during the previous 12 weeks Exposure to anti-CGRP mAbs during the previous 24 weeks Clinically significant cardiovascular disorders
Caudal Epidural Block and DPNB in Hypospadias

Hypospadias, seen in every 200-300 births, is one of the most common congenital anomalies of the penis and is defined as the urethral meatus being located in the ventral part of the penis instead of its normal place. The surgery of this anomaly is very painful in the postoperative period and requires long-term analgesia. Regional anesthesia methods combined with general anesthesia play an important role in providing effective and long-term postoperative pain control in pediatric penile surgery. These methods also reduce postoperative morbidity, enable early mobilization and significantly decrease the need for narcotic analgesics.

The investigator's hypothesis is peripheral nerve blocks are superior to neuraxial blocks as the blocks provide longer-term analgesia and have fewer side effects.

The surgery of hypospadias is very painful in the postoperative period and requires long-term analgesia. A dorsal penile nerve block (DPNB) and caudal epidural block (CEB) are commonly used regional anesthesia techniques for postoperative pain control.

Aims: The primary aim of the current study was to use the duration until the first postoperative analgesic requirement after two different block techniques to compare the analgesic effect. The secondary aims were to compare the two methods for postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scores, complications and parental satisfaction scores.

Eligibility Criteria:
Inclusion Criteria:

* 1-7 years of age
* ASA (American Society of Anesthesiologists) I-II group
* Scheduled for distal hypospadias surgery
* Able to communicate in Turkish
* Willing to participate to the study (parents and children)

Exclusion Criteria:

* Less than 1 or more than 7 years of age
* A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital low back anomaly, liver disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination
* Unwilling to to participate to the study ((parents or children)
Multimedia Aid Gynecologic Counseling and Consent

This is an interventional trial to introduce two short animated videos into preoperative counseling/consent and to compare patient comprehension and satisfaction with a multimedia approach compared to standard of care currently. The investigators anticipate that patients will retain more information about their surgery and peri-operative care and will be more satisfied with a multimedia approach.

The investigators plan a pilot study where patients will be randomized to receiving standard consent and teaching prior to their planned surgery for endometrial cancer or standard consent and multimedia video aid with targeted teaching. This video will be an adjunct to the standard consent process and supplement the pre and post-operative teaching that is currently not formalized. The primary outcome is patient satisfaction. The secondary outcomes include patient understanding and physician satisfaction. The investigators hypothesize that patients will be more satisfied when their consent for surgery is done in conjunction with this multimedia aid.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Has diagnosis of endometrial cancer
* Planned minimally invasive surgical treatment with hysterectomy and sentinel lymph node biopsy

Exclusion Criteria:

* Non-English speaking
* Pregnant
A Study of Zetomipzomib (KZR-616) in Patients with Active Lupus Nephritis (PALIZADE)

The purpose of this study is to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).

This study aims to investigate whether zetomipzomib, added to standard of care treatment in patients with active LN, is able to reduce disease activity over a treatment period of 52 weeks. The background standard of care therapy will be mycophenolate mofetil (MMF) and initial optional treatment with IV methylprednisolone, followed by a tapering course of oral corticosteroids.

Patients are required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis.

Patients will be randomized in a 2:1 ratio to receive either zetomipzomib (30 mg or 60 mg) or placebo administered as a subcutaneous injection once weekly for 52 weeks, followed by a 4-week safety follow-up period. Efficacy will be assessed by measuring the level of proteinuria (as measured by urine protein to creatinine ratio \[UPCR\]) and estimated glomerular filtration rate (eGFR) as compared to current standard of care treatment. Safety will also be assessed throughout the study to ensure an acceptable safety profile.

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index of ≥18 kg/m\^2
* eGFR ≥30 mL/min/1.73 m\^2
* Unequivocally positive ANA test result and/or a positive anti-dsDNA serum antibody test
* Diagnosis of LN according to 2003 or 2018 ISN/RPS criteria and confirmed by renal biopsy performed within 12 months prior to Screening.
* UPCR ≥1.0 (Class III/IV +/-V) or UPCR ≥2.0 (Class V)
* Adequate hematologic, hepatic, and renal function

Key Exclusion Criteria:

* Current or medical history of:

  * Central nervous system manifestations of SLE
  * Overlapping autoimmune condition that may affect study assessments/outcomes
  * Antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to Screening
  * Thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies (i.e., plasmapheresis or acute blood or platelet transfusions
  * Solid organ transplant or planned transplant during study
  * Malignancy of any type, with exceptions for non-melanoma skin cancers and certain cancers \>5 years ago
* Has received dialysis within the 52 weeks prior to Screening
* Positive test at Screening for HIV, hepatitis B/C
* Known intolerance to MMF or equivalent and corticosteroids
Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With HFrEF and a Typical LBBB.

The study will investigate the feasibility of using direct HIS pacing or left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left bundle branch block pattern.

Biventricular pacing has for more than a decade been standard of care for patients with HFrEF, LVEF \< 35%, NYHA II-IV despite optimal medical treatment and an ECG with left bundle branch block (LBBB). However, it is not always ideal because of several drawbacks such as phrenic nerve capture, inability to reach late activated areas and many more. Direct HIS pacing can in many cases capture the left bundle and provide normal electrical activation of the left ventricle but sometimes with high pacing thresholds. Recently direct left bundle branch pacing has shown promise with synchronous activation of the left ventricle at low pacing thresholds.

In the present study we randomize 150 patients in one center to either conventional CRT (45 patients) or HIS/LBB pacing (80 patients). In the HIS/LBB arm, direct HIS-pacing is attempted first but if its not possible or the pacing threshold for capturing the left bundle branch is \> 2.5 V at 1 ms we switch to placing a LBB-lead.

Power calculation for non-inferiority: With the 50 patients in the first His Alternative study (25 Biv-CRT og 25 His-CRT) we observed a fall in systolic volumes of 34% and 46% with a standard deviation of 13-16%. Using these numbers it would take at least 108 patients to be 90% sure that the lower limit of a one-sided 97.5% confidence interval (equal to a 95% two-sided confidence interval) would be over the non-inferiority limit of -10%.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age, ischemic or non-ischemic cardiomyopathy with LVEF ≤ 35% assessed by echocardiography, NYHA class II-IV heart failure symptoms despite optimal medical treatment and

  * Either planned new implantation of a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block (see definition below)
  * Or planned upgrade of an existing pacemaker or ICD to a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block or there has been\> 90% right ventricular pacing from an existing pacemaker for at least 2 months prior to enrollment
* Signed informed consent

Typical left bundle branch block:

QRS width \> 130 msec for women and \> 140 msec for men QS or rS pattern in leads V1 and V2, and mid-QRS plateau phase with or without extras in at least 2 of leads V1, V2, V5, V6, I, and aVL

Exclusion Criteria:

* Existing biventricular pacing system
* Permanent atrial fibrillation
* Severe renal failure with eGFR \< 30 ml/min
* AMI or CABG within the last three months
* The patient does not want to participate
CNS Prophylaxis in Diffuse Large B-cell Lymphoma

Comparison of cumulative incidence of CNS relapses in patients with diffuse large B-cell lymphoma with intermediate or high risk of CNS relapse treated with CNS prophylaxis: either with 2 doses of intravenous methotrexate 3g/m2 i.v.(arm A) or 6 doses of intrathecal methotrexate 12mg (arm B) and in patients with low risk of CNS relapse without CNS prophylaxis (arm C).

Patients with diffuse large B-cell lymphoma are evaluated for risk factors of CNS relapse during initial staging (age \> 60years, lactate dehydrogenase (LDH) \> reference range, clinical stage III/IV, performance status according to Eastern Cooperative Oncology Group (ECOG) \>1, kidney and/or adrenal gland involvement, involvement \> 1 extranodal organ) including evaluation of cerebrospinal fluid.

All patients with systemic DLBCL without CNS involvement are treated with systemic chemotherapy: either 6 cycles of R CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednison) +2xR (rituximab) or 6 cycles of DA EPOCH R (dose adjusted etoposide, prednison, vincristin, cyclophosphamide, doxorubicin) +2xR (rituximab). Patients with ≥ 2 risk factors for CNS relapse or with occult meningeal involvement will be randomized in 1:1 ratio either into arm A with 2 cycles of prophylactic methotrexate 3g/m2 i.v., or into arm B with prophylactic 6x intrathecal methotrexate 12mg (1x intrathecal methotrexate in each cycle of systemic chemotherapy). Patients with 0-1 risk factor will be allocated into arm C without CNS prophylaxis. Patients will be observed for CNS relapse during the follow-up of 1year after the end of the first-line treatment.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed DLBCL
* age 18-72 years
* signed informed consent with the study
* first-line treatment 6 cycles of R CHOP +2x R or 6 cycles of DA EPOCH R+ 2xR

Exclusion Criteria:

* DLBCL and concomitant initial CNS involvement
* PMBL (primary mediastinal B-cell lymphoma)
* treatment with another chemotherapy than R CHOP or DA EPOCH R
* HIV positive, or active hepatitis B or C
* other concomitant serious disease (based on the decision of the physician-investigator)
* non-compliance of a patient
* any contraindication for application of anthracycline based chemotherapy or high dose methotrexate
* pregnancy or breast-feeding
Prospective Evaluation of Frailty in Patients with Head and Neck Tumors Before Curative Intended Therapy

In a prospective study the fragility of patients with head and neck tumors before the start of curative therapy will be assessed.

Primary objective: Fragility is assessed using the G8 questionnaire.

Secondary objectives include the assessment of quality of life and financial burden (EORTC-QLQ C30+ H\&N43), swallowing function, cardiopulmonary resilience (6-minute walk test) and the patient's wishes regarding a prehabilitation program. Epidemiological and disease-related data is also collected.

In this prospective study patients with a tumor of the head and neck region, that are planned for Surgery or radiotherapy (chemotherapy) will be included. The probability of developing therapy-associated side effects is significantly increased if the patient is already in a limited general condition, also known as fragility, before the therapy. In addition, due to demographic change, the incidence of head and neck tumors will continue to increase, especially in patients of advanced age. Due to their age, other pre-existing conditions and infirmity, they are at a further increased risk of therapy-related side effects In order to improve the care of patients with head and neck tumors, we must first determine how many patients are affected by fragility. In addition, we want to determine influencing factors that are associated with fragility. These include, for example, difficulty swallowing and weight loss. Based on this data, we will then plan the implementation of an intervention study to establish a prehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Indication for curative therapy in the case of an initial diagnosis of head and neck tumor disease
* Capacity to consent
* At least 18 years of age
* Sufficient knowledge of the German language

Exclusion Criteria:

* - Lack of capacity to consent
* Age \<18 years
* Severe impairment of walking ability that makes it impossible to perform the 6MWT safely

Contraindications for performing a 6MWT:

Absolute contraindications\* for the procedure are

* unstable angina pectoris
* myocardial infarction in the past month.

Relative contraindications are

* a resting heart rate \> 120/min
* systolic blood pressure \> 180 mmHg
* a diastolic blood pressure \> 100 mmHg.
Determining the Optimal Dose of AD-209 in Patients With Essential Hypertension

The purpose of this study is to determine the optimal dose of AD-209 in patients with Essential Hypertension.

Condition or disease : hypertension Intervention/treatment Drug : AD-209-H Drug : AD-209-M Drug : AD-209-L Drug : Placebo Drug : Amlodipine Drug : Telmisartan Phase : Phase 2

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Other inclusions applied

Exclusion Criteria:

* orthostatic hypotension with symptom
* Other exclusions applied
A Clinical Trial of the Low Dose Chidamide in the Management of Refractory ITP

Nowdays HDACi's were more and more focused on the anti-inflammatory and immunomodulatory activities,independent of their known proapoptotic or cell cycle arrest actions on malignant cells. Low concentrations of HDACi's are effective in reducing inflammation and autoimmune response in humans with juvenile idiopathic arthritis and animal models of inflammatory bowel disease and arthritis. The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of the low dose chidamide in the management of refractory ITP.

The investigators are undertaking a prospective, open, multicentre trial of 30 refractory ITP adult patients from 5 medical centers in China. 1/2 of the participants are randomly selected to receive Chidamide in 2.5 mg po tiw, every four weeks for one cycle and it will be given three cycles. The other part will receive Chidamide in 5 mg po tiw, every four weeks for one cycle and it will be given three cycles. The treatment was discontinued after 3 months without blood index reaction. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of the low dose chidamide in the management of refractory ITP.

Eligibility Criteria:
Inclusion Criteria:

* Refractory ITP patients need of treatment(s) to minimize the risk of clinically significant bleeding primary ITP confirmed by excluding other supervened causes of thrombocytopenia

Exclusion Criteria:

* pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome