cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient is willing and able to provide assent and willing to complete all aspects of the study
* Patient's parent or legal guardian willing and able to provide consent
* Male or female patients 12 through 17 years of age (inclusive)
* Clinical diagnosis of either schizophrenia or bipolar I disorder

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
* A positive test for drugs of abuse
Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?

Post mastectomy pain management is of crucial importance for patients' rehabilitation and quality of life. PECS block is used for acute and chronic post mastectomy pain management. Surgical infiltration is also used in this field. Patients in our study are divided in two groups receiving PECS block or surgical infiltrationbefore incision. Multimodal analgesia is indispensable according to recent guidelines for enhanced postoperative recovery. Pain scores will be assessed during the first 24h postoperatively and at 3 months after surgery.

Patients are randomly assigned to 2 groups, PECS block or surgical infiltration group. Patients assigned to PECS group will receive 30cc of ropivacaine 0,375% where 10cc will be injected between pectoralis major and pectoralis minor and 20cc between pectoralis minor and serratus anterior muscle under ultrasound guidance. Patients assigned to surgical infiltration group will receive 30cc of ropivacaine 0,375% injected by the surgeon. Local aneshetic is administered in both groups after the induction of general anesthesia and before incision. Pain will be assessed at 1, 12, 24h after surgery and at three months after surgery communicating by telephone. Post operative analgesia includes paracetamol 1gr, parecoxib 40 mg (as required) and tramadol as rescue analgesia (1 mg/kg iv up to 3 times daily). Chronic pain will be assessed after 3 months as for prevalence and neuropathic characteristics.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* ASA physical status I-III
* elective partial mastectomy

Exclusion Criteria:

* refusal of patient participation or inability to participate to the study

  * known allergic reaction to drugs included in the study design
  * contraindiations of performance of peripheral regional anesthesia
  * diabetes melitus or known neurological disorder
  * chronic pain disorders under therapy with opioids or other analgesic drugs for chronic pain
  * all male patients
  * all patients not speaking the Greek language
Impact of Sending an Sms on the Rate of Telephone Responses of Subjects Contacted 3 Months After the Suicidal Act

The objective of this controlled, randomized, monocentric study is to compare the response rate of the call at 3 months of the groups with or without short message service (SMS) 48 hours before, for the subjects having benefited from the device "VigilanS Lorraine". The secondary objectives will be to appreciate the satisfaction of the subjects towards the sending of the SMS as well as to compare the delay of suicidal recidivism according to whether the subjects answered or not to the call of evaluation at 3 months of the passage to the act The main question it aims to answer is: What impact, on the rate of successful calls, could sending a text message 48 hours before the 3-month evaluation phone call have on subjects benefiting from the VigilanS device?

The participants will be divided into 2 groups:

* 1st group: SMS sent 48 hours before the 3-month evaluation call planned in the framework of the "VigilanS Lorraine" program.
* 2nd group (control): evaluation call at 3 months planned within the framework of the "VigilanS Lorraine" system, not preceded by an SMS 48 hours before.

The desired effect was an increase in the percentage of successful calls at 3 months, allowing for possible evaluations at 3 months in order to identify, evaluate and accompany subjects still in a suicidal crisis and thus avoid a recurrence of the act and thus a suicide.


Eligibility Criteria:
Inclusion Criteria:

* Having made a suicide attempt (first-time suicide or not)
* Hosted at the Central Hospital of Nancy
* Included in the "VigilanS Lorraine" monitoring system
* Not presenting criteria for non-inclusion in the "VigilanS Lorraine" system, namely:

  * Guardianship
  * Held
  * Dementia
  * Not speaking French
* Subject having received information relating to the progress of the EVAREST 3 study and having given their consent to participate
* Subject affiliated or entitled to a social security scheme

Exclusion Criteria:

* Subject without mobile phone
* Participation in another interventional study on the prevention of suicidal recidivism
* Subject under curatorship who was not assisted by his curator to give his consent to participate
Stem Cell Transplant for High Risk Central Nervous System (CNS) Tumors

The primary goal of this study is to determine if a stem cell transplant in patients with newly diagnosed high risk CNS tumors (glioblastoma multiforme \[GBM\], high grade astrocytoma, pineoblastoma, rhabdoid tumor, supratentorial primitive neuroectodermal tumor \[PNET\]) increases overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Patient's age must be greater than (\>) 18 months and less than or equal to (≤) 25 years at the time of diagnosis or recurrence.
* Neuroradiographic evidence of a recurrent posterior fossa medulloblastoma or recurrent CNS germ cell tumor.
* The presence of a histologically confirmed high grade astrocytoma, GBM, rhabdoid tumor, supratentorial PNET, or pineoblastoma either at the time of diagnosis or recurrence.
* Patients must be brought to state of minimum residual disease by surgical reduction and/or chemotherapy and/or radiation therapy or a combination of above prior to myeloablative chemotherapy and tandem stem cell rescue.
* Documentation of chemotherapy sensitivity is required for enrollment. Chemotherapy-sensitive tumors are defined as those tumors which have had a reduction of 50% after 2-4 cycles of chemotherapy (CTX or platinum). For patients with no evidence of disease post resection, continued complete remission after 2-4 cycles of chemotherapy defines chemosensitivity.
* Adequate physiologic function, defined as follows:

  * creatinine clearance \> 70 ml/minutes/1.73 m2.
  * SGPT \< 10 x normal and bilirubin \< 10 mg/dl.
* Adequate complete blood count (CBC): hemoglobin \> 10 gm/dl, absolute neutrophil count (ANC) \> 1500/ul, and platelets \> 100,000/ul.
* Informed consent. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained, in accordance with institutional policies provided by the United States (U.S.) Department of Health and Human Services.
* Protocol approval. Approval for the use of this institution's Human Rights Committee must be obtained in accordance with the institutional assurance policies of the U. S. Department of Health and Human Services.
* Patients with high-risk medulloblastoma after initial surgery.
* To allow non-English speaking patients to participate in this study, bilingual health care services will be provided in the appropriate language.

Exclusion Criteria:

* Patients with brain stem glioma are ineligible.
The CRT-KIR Study (Cardiac Resynchronization Therapy [CRT] in the Early Phase After Heart Surgery)

In patients with broad QRS complexes on electrocardiogram (ECG), the delayed electrical activation of the left heart chamber will cause abnormal contraction.This has been shown to be possible to treat by a special pacemaker treatment which includes pacing of the left heart chamber (= CRT treatment).

In this study the researchers will investigate the effect of acute CRT treatment in the early phase after open heart surgery.

Patients with bundle branch block have a delayed electrical activation of the left ventricle causing abnormal contractility of the left ventricle.

We hypothesize that patients may benefit from short term (= 72 hours) CRT (Cardiac Resynchronization Therapy) in the early phase after open heart surgery.

Patients: reduced LV function and bundle branch block.

Study type: randomisation to CRT versus standard postoperative treatment

Study variables: cardiac output, echocardiographic measures, p-BNP and hours with inotropic therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for open heart surgery (coronary artery bypass graft \[CABG\] or mitral valve surgery or aortic valve surgery or combinations of the above mentioned surgical procedures) and LV ejection fraction \< 35% and bundle branch block (QRS \> 9.12 s)

Exclusion Criteria:

* Severe right heart failure
* Permanent atrial fibrillation
* Congenital heart disease
* Serious non-cardiac disease
Idiopathic Dilated Cardiomyopathy

To determine the familial occurrence and pathogenesis of idiopathic dilated cardiomyopathy.

BACKGROUND:

In 1987 idiopathic dilated cardiomyopathy was a disorder of unknown cause that directly affected one or both cardiac ventricles in a diffuse or multifactorial fashion, and that produced heart failure, at least in some patients. Although a viral etiology had been proposed, dilated cardiomyopathy could be associated with numerous genetic and non-genetic diseases. However in 1987, the role of genetic factors was not known in humans. Although the condition was usually dismissed as sporadic, numerous families with multiple affected members have been observed.

The role of atrial natriuretic peptide levels in the pathogenesis or progression of idiopathic dilated cardiomyopathy was just beginning to be explored in 1987. Although Syrian hamster studies did not suggest a genetic deficiency as the primary cause of dilated cardiomyopathy in that model, it was thought possible that ANP production or levels were somehow involved in how the myocardium responds in idiopathic dilated cardiomyopathy patients.

DESIGN NARRATIVE:

Eligible patients were interviewed and asked whether any first-degree relatives were willing to participate. If family members participated, a three generation pedigree was constructed and first-degree relatives contacted. The relatives were interviewed for a medical history and medical records from other institutions were reviewed. Each family member had a brief cardiovascular examination, a 12-lead electrocardiogram and 2-dimensional, M-mode, and Doppler echocardiogram. Blood was drawn for determination of atrial natriuretic peptide (ANP) levels. The contributions of variability in age, sex, drug use, smoking, and other concomitants to variability in ANP and echocardiographic data were estimated. After removing these sources of variability, the strength of similarity among family members was assessed. The relative contributions of genes and shared environments to the similarity among family members were estimated.

Heterogeneity in the mean levels of echocardiographic indices and ANP levels, familial aggregation and etiology of aggregation were assessed between families with familial idiopathic dilated cardiomyopathy and families with non-familial idiopathic dilated cardiomyopathy.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effects of Ovarian Reserve on Sexual Satisfaction

This is a survey study. The primary aim of the study is to investigate the relationship between the ovarian reserve and sexual satisfaction. All the patients who underwent ovarian reserve assessment for any reason will fill a questionnaire about sexual satisfaction. And the survey results will be compared with patients' ovarian reserve.


Eligibility Criteria:
Inclusion Criteria:

* Patients who admitted to the gynecology clinic for any reason
* Patients with ovarian reserve tests
* 18-45 years

Exclusion Criteria:

* Mental disorders
* Anatomic genital malformations
* Patient' Decline to fill the survey
* Presence of malignancy
* Without any sexual activity
Baduanjin on Patients With Schizophrenia

As an ancient, popular Chinese exercise, Baduanjin is characterized by symmetrical posture, deep breathing and meditation and easy to learn. Previous studies showed immediate effect of Baduanjin on cognition in patients with schizophrenia.The purpose of this study is to investigate the immediate effect and chronic effect of Baduanjin exercise on physical fitness, cognition and daily functions in middle-aged and older adults with schizophrenia.

A single-blind, 2-arm randomized controlled trial investigating the benefits of Baduanjin exercise on middle-aged and older patients with schizophrenia. A total of 48 participants will be assigned to either 12 weeks of 60-minute two sessions per week Baduanjin exercise group or a brisk walking group. Primary outcomes are physical fitness and cognition functions. Secondary outcomes are dual task performance and daily functions. Evaluation will be completed at baseline, immediately after treatment and 4-week follow up.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of schizophrenia according to the DSM-5.
* Independent adult aged 40 years or older in the day-care center.
* Having a stable mental status without shift in medication and keep in same dose for at least one month.

Exclusion Criteria:

* Serious physical conditions that will impede participation, such as cardiovascular disease, musculoskeletal disease or pulmonary system disease.
* Visual or auditory impairment that precludes completion of assessment.
* Acute psychosis requiring hospitalization.
* Presence of severe withdrawal or profound cognitive disability that cause difficulties in following instructions.
* Participating in another clinical trial at the same time.
Computer-based Attention Training in Patients With Acquired Brain Injury

Investigates computer based cognitive rehabilitation and training using the N-back task with a Visual Search task as an active control. The overall purpose is to provide (further) evidence about the efficacy (or lack of efficacy) of the N-back task and to find points of convergence and divergence between patients with acquired brain injury and non-impaired subjects.


Eligibility Criteria:
Inclusion criteria:

* subjects should be able to do both task at level at the time of recruitment
* Informed consent
* (for brain injured patients) training must not interfere with treatment as usual.
* (for brain injured patients) no symptoms which hinder testing and training. I.e. aphasia, deafness, tetraplegia etc.
A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components

The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is to address current gaps in platelet transfusion safety in selected geographic regions. The objective is to provide access to INTERCEPT PCs for patients who might be at risk of transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus (DENV) in regions in which a substantial proportion of the population has been infected or is at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic infection among qualified blood donors is recognized (Stramer 2012, Adda 2014).

The study is designed as a prospective, open label, multi-center, observational study to evaluate the safety and efficacy of INTERCEPT platelet components.

Upon written informed consent, patients will be transfused with study PCs according to local practices. Each patient will be supported with platelets as clinically indicated in a manner that is consistent with the local standard of care. The study will be conducted in two phases. During the pilot phase, patients will sign informed consent to have study data collected following transfusion with conventional PCs. The objective of the pilot phase is to evaluate study logistics and data collection methods. During the INTERCEPT Treatment Use phase, patients will sign informed consent to receive INTERCEPT PCs, provide blood samples, and collect study data (demographics, transfusion data, and safety data).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a serious disease expected to require or requiring a transfusion of platelet component(s)
* Patient population as defined by each Investigator and their institutional review board (IRB).
* Patient provides written informed consent

Exclusion Criteria

* Documented allergy to psoralens
* Neonatal patients treated with phototherapy devices that emit wavelengths less than 425 nm due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.
* Pregnant women in their third trimester of pregnancy (due to possibility the neonate may need bilirubin light treatment after birth).
Phase I Clinical Trial to Assess Safety of UV Phototherapy for the Prevention of GVHD Post Allogeneic SCT

The primary goal of thos study is to assess safety of Ultraviolet (UV) Phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation (Phase I - Clinical trial). Following allogeneic BMT, patients will be placed on standard GVHD preventive therapy (cyclosporine).

Secondary goals -

* monitoring immune system recovery
* the influence of stem cells origin on therapy and/orGVHD prevention
* the influence of UV-c treatment on survival

clinical data and samples will be collected, during UV-c therapy, 100 days after discharge \& 6 months after discharge - to examine the long-term effect of UV-c treatment on the patient's GVHD status.

Treatment will be given with a portable, easy to operate device named "EUMATRON". this device contains a UV- lamp. 250 cc of blood from a peripheric vein is going through the device into a bottle with Low dose Heparin and returning to patient's body. procedure takes \~20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* patients post non T cell depleted allogeneic stem cell transplantation

Exclusion Criteria:

* morbidity unrelated to GVHD
* patients in an hemodynamic unstable condition
* acute uncontrolled bleeding
* patients undergoing dialysis
Use of Herbal Medicine in Internal Medicine Wards

Herbs are physiologically active substances which can significantly affect the outcome of medical treatment, either by inhibiting or promoting drug disposition or through additive and synergistic effects when used in conjunction with conventional medications. Herb-drug interactions are potentially dangerous, and may be difficult to predict since regulation of the preparations is often lacking, and patients most often do not report the use of these products to their physicians. The risk for toxic effects and adverse interactions increases among high-risk groups, such as the elderly or patients with renal or hepatic disease. The purpose of this study is to study the prevalence of use of herbal medicine among patients hospitalized in the internal medicine department of an Israeli hospital, as well as examine the effect of herbal remedies on patient health, either beneficial or harmful. For this purpose, a questionnaire evaluating demographic data, medical history (both current and past), use of and attitudes towards herbal medicine will be administered to patients in the Department of Internal Medicine at the Shaare Zedek Medical Center in Israel. The Beck Depression Questionnaire will be used as well.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either gender
* Age 18 years and older

Exclusion Criteria:

* Neurological deficit or other medical condition precluding responding to the questionnaires.
Assessing Different Methods of Anxiety Care in Pediatric Settings

This study will compare the effectiveness of delivering cognitive behavioral therapy for children with anxiety disorders through in-person contact versus through workbooks and telephone communication.

Approximately 13% of adolescents aged 9 to 17 suffer from an anxiety disorder, which can cause disruptive fear, worry, or uneasiness that impairs their normal functioning. These anxiety disorders can include generalized anxiety disorder (GAD), phobias, panic disorder, and obsessive-compulsive disorder (OCD), and they often co-occur with a second anxiety disorder or another mental or behavioral disorder, like depression. Research on interventions such as cognitive behavioral therapy (CBT) indicates that these interventions are helpful to children who suffer from anxiety disorders, but are not always used. This study will examine the feasibility of implementing CBT for children between the ages of 8 and 13 in two different forms: through in-person contact at the pediatric primary care setting and through telephone-based contact.

Participants in this study will be randomly assigned to receive either cognitive behavioral therapy in primary care (CBT-PC) or therapist-assisted bibliotherapy in primary care (TAB-PC). In CBT-PC, participants will have therapy administered by a child anxiety specialist, and the parents of participants will learn how to support the new skills their children learn in therapy. In TAB-PC, parents will receive educational workbooks and ongoing support over the phone from a child anxiety specialist to learn how to use CBT skills to manage their children's fears and worries. Participation in this study will last 3 to 4 months, with therapy visits occuring once a week at the beginning and tapering to once every other week at the end of treatment. At pre-treatment, mid-treatment, post-treatment, and a 3-month follow-up, participants will undergo structured clinical interviews to assess their anxiety levels and the severity of their conditions.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for one of the following disorders: separation anxiety disorder, social phobia, generalized anxiety disorder, specific phobia, or obsessive-compulsive disorder
* Takes a medication and has maintained a stable dose for 3 months before baseline assessment
* Pediatric medical care is provided through one of the participating primary care clinics
* Parent and child are fluent in English

Exclusion Criteria:

* Presence of a life threatening condition or a medical illness that would make participation unsafe
* Diagnosed with bipolar disorder I, mental retardation, or autism or has psychotic symptoms
* Acutely suicidal or homicidal or exhibiting dangerous behavior
* Parents do not consent for diagnosis and progress to be shared with their child's primary care physician
A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation

The purpose of the study is to measure the safety and efficacy of three doses of varenicline for smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have smoked on average of at least ten cigarettes per day during the past year
* Subjects must have no period of abstinence greater than three months in the past year

Exclusion Criteria:

* Subjects with any history of cardiovascular disease
* Myocardial infarction
* Significant arrhythmias
* Poorly controlled hypertension