cyrilzakka/clinical-trials huggingface dataset:
Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy

Pilot, controled, randomized study aiming to evaluate a plan for the prevention of risks related to epilepsy, 3 months after the last therapeutic patient education session. Two groups of patients will be compared: group "intervention" (consultation with the neurologist then a psychologist followed by a session dedicated to risk prevention ("Recognize and Manage risks") integrated into usual Therapeutic Patient Education (TPE) versus "control" group (usual consultations with the neurologist and usual TPE).

37 subjects per group will be included in this study.

The study will be proposed to patients with uncontrolled epilepsy (n=74) aged 18 to 40.

The investigators will evaluate 3 months after the last therapeutic patient session, the impact of the epilepsy-related risk prevention system on the self-management of epilepsy ("Safety Management" score of the Epilepsy Self Management Scale (ESMS). This scale has 5 dimensions (5 sub-scores): treatment management, information management, safety management, seizure management and lifestyle management.

Each clinical investigation team works in collaboration with a clinical psychologist for psychological assessment interviews.

The implementation of such a plan should enable patient to acquire so-called safety skills aimed at protecting his life, reducing risky behavior and increasing medication compliance.

Eligibility Criteria:
Inclusion Criteria:

* Patient between 18 and 40 years old
* Patient with poorly controlled epilepsy (persistence of seizures evolving for more than a year despite proper treatment).
* Patient agreeing to participate in a therapeutic education program (TPE)

Exclusion Criteria:

* Epileptic patient who has already benefited from a TPE epilepsy program
* Patients with major cognitive impairment
* Patient deprived of liberty by court or administrative decision, subject to a legal protection measure (guardianship or curatorship)
* Pregnant or breast-feeding women
* Failure to obtain written informed consent after a reflection period
* Patient who for geographical, social or psychological reasons could not participate in the research
* Any situation that, in the opinion of the investigator, could present risks to the patient and to the research
* Participation in another therapeutic research
* Subjects not covered by public health insurance
The Effect of Electroacupuncture on Obesity

The purpose of this study is to determine whether electroacupuncture is effective on waist circumference in obesity.

Many studies have reported on the beneficial effects of acupuncture for obesity, although some negative reports also existed.(Wang F. et al. 2008)Recently conducted systematic review of Pittler and Ernst reported that there was insufficient, but not conclusive evidence to support the efficacy of acupuncture and acupressure for weight loss. However, most of these studies had methodological limitation, such as lack of adequate control group or unclear specific effect of electroacupuncture alone because auricular acupuncture was administered as well. In this sudy, we had three-arm randomized controlled trial(with sham control group) to investigate whether electroacupuncture is effective in the treatment of obesity.

Eligibility Criteria:
Inclusion Criteria:

* Waist circumference: Male\>= 90 cm, Female \>= 85 cm
* BMI over than 25kg/m2

Exclusion Criteria:

* Secondary obesity caused by endocrine disease, e.g., polycystic ovary syndrome, diabetes mellitus, Cushing's syndrome, hypothyroidism etc.
* Heart disease,e.g.,arrhythmia, heart failure, myocardial infarction, and patient with pacemaker
* Hypertension, hyperlipidemia or hypercholesterinemia patients on medication
* Stroke or otherwise unable to exercise
* Pregnant or lactating women
* Childbirth within 6 months
* Management for weight control within 3 months
* Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge
Clinical Application and Outcome of Non-invasive Ventilation in Different Chest Diseases

Noninvasive ventilation is increasingly used method of respiratory management in both the emergency room and critical care. Noninvasive ventilation delivers mechanically assisted breaths without the placement of an artificial airway and has become an important mechanism of ventilator support inside and outside the intensive care unit.

Noninvasive ventilation is further subdivided into negative pressure ventilation which is the iron lung, first used in 1928 and the Hayek oscillator, is a more recently designed to provide negative pressure during inspiration and positive pressure during expiration. Noninvasive positive pressure ventilation can be used as continuous positive airway pressure or bi-level positive airway pressure.


Eligibility Criteria:
Inclusion Criteria:

* obstructive sleep apnea syndrome
* acute exacerbation Chronic obstructive pulmonary disease
* pneumonia
* interstitial lung diseases

Exclusion Criteria:

* Patients refuse Non invasive ventilation
* Patients with absolute indication for Mechanical ventilator (in respiratory arrest or unstable cardiorespiratory status, trauma or burns involving the face, or gastric surgery, reduced consciousness, Pneumothorax
* Patients with contraindication to Non invasive ventilation
Impact of Echocardiography on Management of Critically Ill Neonates

The goal of the study was to estimate the outcome (mortality and morbidity) among hemodynamically unstable neonates, as well as the time to return to hemodynamic stability following the use of ECHO in the management of hemodynamically unstable neonates.

-All patients will be subjected to : Full clinical examination for manifestation or signs of hemodynamic instability and daily thereafter until discharge.

An echocardiographic assessment using Vivid T8 Pro ( GE MEDICAL SYSTEMS ( CHINA ) CO, LTD.) is done if manifestations of hemodynamic instability or shock appeared.

The imaging planes were identified by transducer location (subxiphoid, apical, parasternal, suprasternal notch, and right parasternal). The segmental approach was used to describe all of the major cardiovascular structures in sequence.

Suggested plan of management will be as the following:

1. Neonates with low LVO and impaired left ventricular contractility: dobutamine at a dose of 5-20 μg/kg/min was given, and if no improvement, volume expansion as a single intravenous infusion of 10-20 ml/kg of the crystalloid solution was given. If still no improvement, hydrocortisone at a dose of 1 mg/kg every 4 h was added. If improvement was not achieved, epinephrine was added at a dose of 0.05-2.6 μg/kg/min \[11\].
2. Neonates with LVO and hypovolemia (under-filled left ventricle): volume expansion as a single intravenous infusion of 10-20 ml/kg of the crystalloid solution will be given. If still no improvement, it was repeated \[11\].
3. Neonates with normal or high LVO without PDA: dopamine at a dose of 5-20 μg/kg/min is given. If no improvement, hydrocortisone at a dose of 1 mg/kg every 4 h is added. If improvement was not achieved, epinephrine is added at a dose of 0.05-2.6 μg/kg/min \[11\].
4. Neonates with normal or high LVO and hemodynamically significant PDA: PDA will be treated either medically or surgically \[11\].
5. During the current study period, all previously mentioned hemodynamically unstable neonate values were compared to values collected from the controlled group (200 hemodynamically stable neonates).
6. Neonates will be monitored regularly and subjected to repeated echocardiographic and clinical examinations to detect clinical and laboratory findings suggestive of hemodynamic instability or shock.

Eligibility Criteria:
Inclusion Criteria:

* All neonates ( age 0 to 28 days) admitted to the NICU of Sohag University Hospital during the period of the study in whom manifestations of hemodynamic instability or critical illness were elected regardless of gestational age, weight, gender, or type of disease.

Exclusion Criteria:

* Failure to obtain informed consent .
* Presence of congenital heart disease apart from PDA , PFO \& small ASD .
Venetoclax and Lintuzumab-Ac225 in AML Patients

The study is a multicenter, open label Phase I/II trial.

1. To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 added to venetoclax for patients with CD33 positive relapsed/refractory AML. (Phase 1 portion)
2. To assess the percentage of patients with CR, CRh, or Overall Response (CR + CRh), up to 6 months after the start of treatment without receiving other AML therapies. (Phase 2 portion)

The study is a multicenter, open label Phase I and Phase II trial combining lintuzumab-Ac225 with venetoclax in patients who have relapsed or refractory AML.

The Phase I portion is a dose-finding study which will enroll at least three patients at each dose level. Patients in a dose level will be observed for a minimum of 4 weeks before dose escalation occurs. There is no dose escalation for any individual patient.

The Phase II portion of the study will enroll patients at the MTD dose level of lintuzumab-Ac225 as determined in the Phase I portion of the study. The goal of the Phase II portion will be to further characterize the safety and efficacy of the MTD dose of lintuzumab-Ac225.

Eligibility Criteria:
Inclusion Criteria:

1. Refractory or relapsed AML which will include:

   1. Refractory disease will be defined as at least 1 prior treatment with no remission.
   2. Relapsed disease will be defined as 5% or more blasts in bone marrow seen after remission.
   3. Patients with AML arising from myelodysplastic syndromes (including CMML) or myeloproliferative neoplasms (secondary AML, ts-AML) are also eligible.
2. Circulating blast count ≤ 200/μL within 10 days prior to first cycle of treatment. Hydroxyurea should be used to keep the peripheral blast count ≤ 200/μL until the first day of protocol treatment, to the extent that this is possible
3. ECOG ≤ 2
4. Estimated creatinine clearance ≥ 50 mL/min
5. AST and ALT ≤ 3.0 x ULN
6. Bilirubin ≤ 3.0 x ULN

Exclusion Criteria:

1. Active CNS Leukemia.
2. Known HIV infection or known hepatitis B or hepatitis C infection (with a detectable viral load).
3. Participant has received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment.
4. Secondary refractory AML (e.g., treated for current relapse without achieving remission);

   a. With the exception that single agent FLT3 inhibitors, IDH1/IDH2 inhibitors are allowed for current relapse without achieving remission.
5. Have received prior radiation to maximally tolerated levels to any critical normal organ.
6. Clinically significant cardiac disease.
7. Active, uncontrolled serious infection.
8. Have other non-myeloid malignancy within 2 years of entry (with exceptions).
9. Psychiatric disorder that would preclude study participation
10. Previous solid organ transplant (prior treatment with SCT is allowed but not if patient has GVHD or is still receiving immunosuppression/GVHD therapy).
An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors).

This is an open-label (all people know the identity of the intervention), single-arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy. Abiraterone acetate oral tablet will be administered as a total dose of 1000 milligram (mg) orally (by mouth) once daily after an overnight fast and prednisone/prednisolone will be administered as 5 mg oral tablet twice daily. Participants will be enrolled and treated up to 12 cycles (or longer, if they have not progressed and continue to benefit from treatment). The study will consist of 3 parts: Screening (14 days), Open-label Treatment; and follow-up (up to 60 months). Participants will be evaluated primarily for prostate specific antigen response according to Prostate Specific Antigen Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma (malignant epithelial tumor with a glandular organization)of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum), but not with neuroendocrine (specialized neurons that produce hormones, such as neuropeptides or biogenic amines) differentiation or of small cell histology
* Prior chemotherapy (treatment of disease, usually cancer, by chemical agents) for prostate cancer with regimen(s) containing docetaxel
* Documented prostate specific antigen (PSA) progression according to Prostate Specific Antigen Working Group (PSAWG) eligibility criteria with a PSA more than (\>) 5 nanogram per milliliter (ng/mL) or objective progression by Response Evaluation Criteria in Solid Tumors (RESIST) criteria
* Ongoing androgen deprivation with serum testosterone less than (\<) 50 nanogram per deciliter (ng/dL)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of less than equal to (\<=) 2 (Karnofsky Performance Status \>= 50 percent)

Exclusion Criteria:

* Active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy
* Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
* Uncontrolled hypertension (high blood pressure)
* Hemoglobin \<=9.0 gram per deciliter (g/dL) without growth factor or transfusion support
* Abnormal liver (large organ that helps in many body functions, including digestion, metabolism, and storage of substances) function
A Real World Study Based on NGS (TRUMPRWS)

This is a descriptive observational study, in which data are collected in an epidemiological fashion. This study does not intend to alter or intervene the current medical practice of the recruited patients. Data will be collected in prospective manner.

This is a descriptive observational study, in which data are collected in an epidemiological fashion. This study does not intend to alter or intervene the current medical practice of the recruited patients. Data will be collected in prospective manner.

The eligible patients will be recruited after NGS analysis for tumor tissue and the inform-consent is obtained. The study required information will be collected (every 3 months).

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be ≥20 years of age.
2. Provision of fully informed consent prior to any study specific procedures.
3. Histologically or cytologically confirmed, unresectable stage IIIB or stage IV NSCLC.
4. Genetic variants of tumor tissue detected by NGS.

Exclusion Criteria:

None.
CKD-581 + Lenalidomide + Dexamethasone in Patients With Previously Treated Multiple Myeloma

This study is to determine the maximum tolerated dose(MTD) and recommened phase 2 dose(RP2D) based on dose limiting toxicity(DLT), and to evaluate safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination with Lenalidomide and Dexamethasone in patients with Previously Treated Multiple Myeloma.

This is an open label, dose escalation study. Cohort of 3\~6 patients receive escalation doses of CKD-516 until the maximum tolerated dose(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

Eligibility Criteria:
Inclusion Criteria:

* must have received at least two prior lines of therapy and Diagnosis of symptomatic multiple myeloma(IMWG 2015)
* Eastern Cooperative Oncology Group performance status ≤ 2
* Life expectancy 12 weeks
* must have the following laboratory values within 3 weeks prior to first dose of study drug

  * absolute neutrophil count(ANC) ≥ 1,500 mm3
  * platelet count(PLT)≥ 100,000 mm3
  * Hb ≥ 9.0g/dL
  * AST(SGOT) and ALT(SGPT) ≤ 3 x upper limit of normal(UNL)
  * Serum bilirubin ≤ 1.5 x ULN (but, Gilbert syndrome ≤ 3 x UNL)
  * Creatinin Clearance(CrCl) ≤ 50mL/min
* One more measureable disease following values

  * Serum M-protein ≥ 1g/dL
  * Urine M-Protein ≥ 200mg/24hr
  * in that case serum M-protein, urine M-Protein nonmeasurable and FLC ratio abnormal, Serum free light chain(FLC) level ≥ 100mg/L(≥10mg/dL)
* more than 24 weeks prior to last lenalidomide dose
* must have signed the consent form

Exclusion Criteria:

* Patients with CNS disease
* Patients with clinically significant heart disease within 24weeks prior to first dose of study drug
* patients with clinically significans abnormal EKG, echocardiography at screening
* patients with patients with embolism within 24 weeks
* patients with active hepatitis, HIV positive(exception, non active hepatitis)
* peripheral neuropathy ≥ CTCAE grade 2 within 2 weeks prior to first dose of study drug
* Patients with clinically significant disease
* Patients with a prior malignancy with in the last 3 years except adequately treated basal cell or squamous cell or skin cancer, in situ cervical cancer
* Patients who have received surgery, chemotherapy, radiation therapy or immunotherapy or any other investigational drugs ≤ 4 weeks prior to first dose of study drug and during treatment period
* Patients who can not anticoagulate
* Patients who have received dexamethasone \>10mg/day within 2week prior to first dose of study drug and during treatment period
* Women who are pregnant or breast feeding or women of childbearing potential not using an effective method of birth control. Male patients whose sexual partners are not using effective birth control.
* patients with hypersensitive reaction of lenalidomide or dexamethasone
Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children


Eligibility Criteria:
Inclusion Criteria:

* infants from 2 to 24 months both inclusive
* suffering from recurrent cough associated with other allergic symptoms
* hospitalized for respiratory or allergy related problems
* laboratory results within normal ranges
* height and weight between percentile 5 and 95

Exclusion Criteria:

* having taken any of the disallowed medication
* suffering form any disorder
* history of sleep apnea
* having concomitant chronic disease
* known relevant renal, hepatic, cardiac or metabolism dysfunction
* known alcohol or drug addiction, severe psychiatric disease for the parent/guardian
Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects

This is a Phase I, single center, open-label study of the dietary supplement calcium formate in normal, healthy female subjects. The purpose of the study is to determine whether daily use of calcium formate is safe and whether it accumulates in the eye.

This is a Phase I, single center, open-label study of the dietary supplement calcium formate in normal, healthy female subjects. The purpose of the study is to determine whether daily use of calcium formate is safe and whether it accumulates in the eye.

Eligibility Criteria:
Inclusion Criteria:

* Healthy females

Exclusion Criteria:

* no ocular diseases
Drug-Drug Interaction (DDI) Study for TD-9855

This study is designed to assess the effect of fluvoxamine, itraconazole and smoking on the PK disposition of multiple doses TD-9855 in healthy male subjects. The study will also assess the relationship between caffeine PK and TD-9855 PK disposition in healthy male smokers and non-smokers.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give written, signed informed consent
* Male subjects 19 to 55 years of age (inclusive)
* Body mass index 19 to 32 kg/m2 (inclusive), and weigh at least 55 kg
* No clinically important abnormal physical findings as determined by the Principal Investigator (PI) at the screening and Day -1 examinations
* Negative for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) antibody at screening.
* No clinically important laboratory abnormalities as determined by the PI
* Ability to communicate effectively with the Investigator and to comply with all study requirements, restrictions, and direction of the clinic staff
* Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
* Male smokers: Subjects who self-report to have smoked \> 9 cigarettes per day for at least 6 month prior to screening as confirmed by urine cotinine test at screening and Day -1.
* Male smokers: Subjects must be willing to continue consistent use of their tobacco products throughout the study.
* Additional inclusion criteria apply

Exclusion Criteria:

* Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) antibody at screening.
* History or presence of clinically significant respiratory, gastrointestinal, renal, hepatic, hematologic, neurologic (including history of seizure and insomnia), cardiovascular (including postural orthostatic hypotension or tachycardia), psychiatric (including depression and known addictive disorders), musculoskeletal, genitourinary (including urinary retention), immunologic, or dermatologic disorder.
* Any other condition that, in the opinion of the PI, would confound or interfere with study participation; evaluation of safety, tolerability, or PK of the investigational drug; or prevent compliance with the study protocol
* Any history of suicide attempts/ideation or current suicidal ideation.
* Have participated in another clinical trial of an investigational drug (or medical device) within 30 days (or 5 half-lives of the investigational drug if longer than 30 days) prior to Screening, or are currently participating in another trial of an investigational drug (or medical device), or intending to participate in another trial of an investigational drug (or medical device) before completion of all scheduled safety evaluations in this trial
* Additional inclusion criteria apply