cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

This clinical study was a 48-week, multicenter, multinational, open-label extension study in pediatric outpatients with autism, Asperger's Disorder, or PDD-NOS conducted at 106 study centers. Patients were eligible for this long-term extension study if they had:

* completed the open-label Study MEM MD 67,or
* completed the open-label Study MEM-MD-91, or
* completed the double-blind Study MEM-MD-68, or
* discontinued study MEM-MD-68 by meeting requirements for loss of therapeutic response

The weight-based dose limits in this study were as follows:

Group A: ≥ 60 kg; maximum 15 mg/day Group B: 40-59 kg; maximum 9 mg/day Group C: 20-39 kg; maximum 6 mg/day Group D: \< 20 kg; maximum 3 mg/day

The decision to close the study early was based on data from 2 double-blind placebo-controlled studies (MEM-MD-57A and MEM-MD-68) that failed to demonstrate a statistically significant difference between memantine and placebo in the primary efficacy parameter based on Social Responsiveness Scale (SRS) total raw score.

Eligibility Criteria:
Inclusion Criteria:

* Patients who completed Study MEM-MD-67, MEM-MD-68, MEM-MD-91, or discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response.
* Having normal results from a physical examination and laboratory tests at Visit 1 of this study (last visit of the preceding study). Any abnormal findings must be deemed not clinically significant by the Investigator and documented as such.
* Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study

Exclusion Criteria:

* Patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug
* Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being
* Significant risk of suicidality based on the Investigator's judgment, Aberrant Behavior Checklist-irritability subscale (ABC-I), or if appropriate, as indicated by a response of "yes" to questions 4 or 5 in the suicidal ideation section of the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) or any suicidal behavior
Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis

This observational study is designed to provide a better understanding of the potential use of interferon gamma (IFNγ) and IFNγ-inducible chemokines as markers of HLH disease activity in adults, and the potential of IFNγ to represent a therapeutic target.

This is a observational study designed to determine the levels of pro-inflammatory markers in adult patients diagnosed with HLH and to assess the relationship between the biomarkers and disease activity in these patients during the HLH course. Inflammatory markers include IFNγ and IFNγ-induced chemokines C-X-C chemokine ligand 9 and C-X-C chemokine ligand 10.

In addition to the blood samples for the biomarker analysis, relevant information gathered by the treating physician will be collected in a data collection form. Whenever possible, collection of serum samples for biomarker analysis and relevant information should occur at HLH diagnosis, at regular time intervals during the treatment course (not more than once a week) up to resolution of HLH.

Blood samples will also be sent to the study sponsor (NovImmune S.A.) for cytokine testing. Before patient's samples are sent to the sponsor for testing, patient's name and any personal identifying information will be coded to protect participant's privacy.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>=18 years old diagnosed with active HLH as established by the treating physician.
* HLH forms of unknown origin or secondary to infections or rheumatologic disorders.
* Should the diagnosis of primary HLH or malignancy become apparent after inclusion, the data collected will be analyzed separately as additional cohorts.
* The patient must have consented to the use of their clinical data for research purposes at the site.

Exclusion Criteria:

* Patients with primary HLH (diagnosed by the presence of homozygous mutations in a known HLH causative gene) and secondary HLH due to malignancy are excluded.
Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy

This study use an observational study design from patient medical records to obtain data on patient demographics, nutritional status, 6MP dosing, and albumin levels of LLA child patients.

All medical record data of LLA child patient at maintenance phase therapy, who came to Cipto Mangunkusumo Kiara Hospital in period 2014 - 2016. the data that are colected consist of age, gender, disease stratification, nutritional status, the dosage of 6-MP, albumin levels, hemoglobin levels, leukocyite counts, platelet counts, and absolute neutrophil counts.

Eligibility Criteria:
Medical record of Acute Limphoblastic Leukemia patients at Cipto Mangunkusumo Hospital, in period of 2012 - 2014, with Inclusion Criteria:

* LLA Patients, male and female, age 1 - \<18 years
* Received chemotherapy maintenance phase based on Indonesian protocol of ALL - 2013

Exclusion Criteria:

* Incomplete medical record data.
Machine-learning Based Prediction Model in Primary Immune Thrombocytopenia

This study developed the first prediction model for risk of critical ITP bleeds for ITP inpatients using a novel machine learning algorithm. This model has been implemented as a web-based model so that clinicians can obtain the estimated probability of critical ITP bleeds for ITP inpatients. The objective of this study is to prospectively and externally validate the risk of critical ITP bleeds in newly admitted ITP patients.

Primary immune thrombocytopenia (ITP) is a common acquired autoimmune disease characterized by reduced platelet production and increased platelet destruction due to autoimmune disorders, as patients present with low platelet counts and a high risk of bleeding. Although most ITP patients present a good prognosis, the rare but important critical ITP bleeds events are the threatening-life complication to ITP patients, severely affecting their prognosis, quality of life and treatment decisions.

More recently, the development of clinical prediction models has provided powerful tools for precision diagnosis and early intervention of diseases, especially the application of machine learning methods. Machine learning approaches can overcome some of the limitations of current risk prediction analysis methods by applying computer algorithms to large data sets with numerous multidimensional variables, capturing the high-dimensional nonlinear relationships between clinical features to produce data, drive outcome prediction.

It suggests an unmet need for personalized patient management strategies and an urgent need for effective tools to predict the risk of critical ITP bleeds in hospitalized patients in medical practice.

Here, we aim to integrate clinical and laboratory data based on a nationwide multicenter study in China to build a clinical prediction model. In particular, we also perform external and prospective validation with large sample sizes to improve the robustness and utility of our models.

It is a simple and convenient tool to quickly assess newly admitted ITP patients and achieve early identification and intervention for those at high risk of life-threatening bleeding events, thus reducing disability and mortality rates in the future.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed ITP diagnosis;

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
2. Current HIV infection or hepatitis B virus or hepatitis C virus infections;
3. Maligancy;
4. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy
5. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
6. Patients who are deemed unsuitable for the study by the investigator.
Paracetamol on Postoperative Nausea and Vomiting

The drugs with both high potency and low side effects are preferred in the prevention of postoperative nausea and vomiting (PONV) which is a common problem. This prospective randomized study aimed to compare the efficacy of paracetamol on PONV in adults undergoing maxillofacial surgery.

One hundred-twenty patients are randomly divided into two groups; the paracetamol group who received the IV infusion of paracetamol (1.5 ml/kg); and the metoclopramide group who received the IV infusion of saline (1.5 mg/kg). The presence of vomiting and the actions indicative of nausea, such as repeated gagging or spitting, within 24h following general anesthesia are defined as PONV. All PONV episodes and postoperative pain scores are recorded during 24h postoperatively. The postoperative 0-4h and 4-24h are defined as early and late postoperative period, respectively. Intravenous 4 mg ondansetron as rescue antiemetic drug is administered in case of two or more vomiting episodes.

Eligibility Criteria:
Inclusion Criteria:

* ASA (the classification of the American Society of Anesthesiologists) physical status I-II
* Patients who scheduled for elective maxillofacial surgery under general anesthesia

Exclusion Criteria:

* Patients with a history of allergy to any of the study medications (opioid, general anesthetic agents or paracetamol)
* History of opioid use, hepatic or renal disease, coronary, psychotic and neurologic diseases
* Use of antiemetic, antihistaminic, analgesic or corticosteroid 24 hours (h) prior to surgery
Brisk Walking Study in Nursing Home Residents

It is well established that physical activity reduces the physiological effects of ageing. Among them, the decrease of the autonomic nervous system activity (ANS) is associated with the increase of cardiovascular events and sleep disorders occurence. It has been shown that high intensity cycle training can enhance the ANS activity by 30% in people aged of 70 years old. However, such trainings were done by old athletes used to train at intensities that could not be handled by nursing home elderly. Thus, an adapted activity such as brisk walking shall be defined to make it practicable for the many in convalescent homes. The investigators hypothesize that long term brisk walking training could lead to reactivate ANS in people living in convalescent homes.

The investigators aim to compare the effects of a 9 month brisk walking training (1 time a week or 3 times a week) on the ANS of nursing home residents.

Eligibility Criteria:
Inclusion Criteria:

* Being over 60 years old
* Living in a nursing home of Mutualité Française de la Loire, France
* Being able to walk without human aid
* Being able to speak and write French
* Being inactive (less than 1 hours of physical activity per week)
* Having a normal sinus rhythm
* Being affiliated to the social welfare system
* Signing the informed consent form

Exclusion Criteria:

* Having serious balance disorders
* Suffering from cardiac or respiratory pathologies that contraindicate physical activity
* Serious comorbidities contraindicating physical activity
* Diagnosed cardiac pathologies that prevent heart rate variability analysis: congestive heart failure, cardiac pacemaker, implantable cardioverter defibrillator, serious ventricular rhythm troubles, atrial fibrillation, atrial flutter.
* Persons under legal protection
VolulyteTM in Cardiac Surgery

The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* male or female adult patients
* undergoing primary elective cardiac surgery applying extracorporeal circulation
* signed written informed consent

Exclusion Criteria:

* known contraindication against scheduled medication
* pre-operative acute normovolaemic haemodilution or preoperative autologous blood donation
* planned systemic hypothermia (body temperature \< 30°C)
* expected time on ECC ≥ 2 hours
The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene

The aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in women undergoing induction of ovulation using clomiphene citrate.


Eligibility Criteria:
Inclusion Criteria:

* Women age 21-35 years.
* Anovulatory cycles due to polycystic ovaries syndrome.
* Non-smokers.
* Free of major medical illness

Exclusion Criteria:

* Women with myoma or adenomyosis
* Women with congenital uterine anomaly.
* Chronic use of any medications including non-steroidal anti-inflammatory drugs.
* Associated cases of infertility other than PCOs (male factor, tubal factor,....).
* Asherman syndrome.
* Cases with endometrial hyperplasia.
* Cases with endometrial polyp
The British Heart Foundation SENIOR-RITA Trial

SENIOR-RITA is a multicentre prospective open-label trial randomizing patients presenting with type 1 NSTEMI aged ≥75 years between invasive and conservative treatment strategies, to compare time from randomisation to cardiovascular death or non-fatal MI

The population is getting older and heart artery disease is the biggest killer in the UK. Over recent years, there have been improvements in medications and technologies to treat it, but these have been primarily tested in younger patients. Previous research studies suggest that older patients (75 years and over) are not well represented in clinical research and these patients in particular those that are frail and those with co-morbidities are less likely to receive advanced medications and medical procedures. The current study will enrol patients 75 years and over, presenting with a heart attack. If patients agree to participate, they will be randomly allocated to one of two treatment groups. In the first group, patients will receive the latest medications recommended in heart attack. In the second group, in addition to these medications, patients will have coronary angiography. This will show whether they have any blockages in heart arteries. If appropriate, coronary revascularisation by percutaneous coronary intervention (PCI) commonly known as coronary angioplasty or coronary artery bypass grafting, sometimes called CABG (a surgical procedure in which a blood vessel from the leg, arm or chest is used to bypass a narrowed section of a coronary artery) will be carried out. During the trial, frailty scores, cognition measures, co-morbidity indices, questionnaires on quality of life, NHS and personal social services utilization will be collected from the participant and in addition proxy quality of life information will be collected from the participant's carers. Investigators will evaluate which one of the two treatment groups will do better and live longer. Investigators will also collect information on their quality of life and frailty measures for a 5 year period. The trial hopes to recruit 2300 patients from approximately 30 centres across the UK.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 75 years
* Type 1 NSTEMI during index hospitalisation

Exclusion Criteria:

* Patients presenting with STEMI or unstable angina
* Patients with cardiogenic shock
* Patients with known life expectancy \<1 year
* Patients in whom neither the patient nor the consultee are able and willing to provide written informed consent
* Previous inclusion in the BHF SENIOR-RITA trial
* Inability to undergo invasive coronary angiography, such as no vascular access site, or absolute contraindication to coronary revascularisation
Different Levels of Guidance in iCBT for Depression (RCT)

The study examines the effectiveness of a internet-based self-help-program called Selfapy for individuals who are experiencing mental stress. The main objective of the study is to investigate the extent to which Selfapy leads to a significant reduction in depressive symptoms. As this study is the first to evaluate the program Selfapy, also quality of life and acceptance of the program are evaluated. The study is conducted as a randomized-controlled trial with parallel assignment into three conditions. The groups were organized into one wait-list control group and two groups receiving access to Selfapy with different levels of guidance.

The study examines the effectiveness of a internet-based self-help-program called Selfapy for individuals who are experiencing mental stress. The main objective of the study is to investigate the extent to which Selfapy leads to a significant reduction in depressive symptoms. As this study is the first to evaluate the program Selfapy, also quality of life and acceptance of the program are evaluated. The primary outcome is the PHQ-9 as a measure of the severity of depressive symptoms, combined with the BDI-II. Secondary outcomes are rates of quality of life and satisfaction with the program, which were measured with the WHOQOL-BREF and ZUF-8. The study is conducted as a randomized-controlled trial with parallel assignment into three conditions over the course of three months. The groups were organized into one wait-list control group, one that received Selfapy with additional peer support and one that received Selfapy with therapeutic guidance.The wait-list control group received access to the program after completion of the post-survey.

Eligibility Criteria:
Inclusion Criteria:

Subjective psychological distress caused by depressive symptoms, wish for treatment, access to Internet, sufficient knowledge of the German language.

Exclusion Criteria:

Acute suicidal tendencies, lifetime diagnoses of schizophrenia or bipolar disorder, presence of neurological or dementia disease.
Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance

During this study, the pharmacodynamic interactions between sevoflurane and remifentanil will be studied.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesia class I and II patients
* Aged 18-60 years
* Scheduled for surgery under general anesthesia

Exclusion Criteria:

* Weight less than 70% or more than 130% of ideal body weight
* Neurological disorder
* Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction (AMI), any valvular and/or muscular disease involving decrease of the ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/automatic implantable cardioverter defibrillator \[AICD\])
* Pulmonary disease including asthma, severe chronic obstructive pulmonary disease (COPD), etc.
* Gastric diseases including reflux, endocrinological diseases
* Recent use of psycho-active medication, including alcohol.
The Effects of Ultrasound on Central Nervous System

Focused ultrasound at low intensities is a form of neuromodulation with high spatial resolution that can be applied invasively or non-invasively using acoustic energy to affect neuronal activity. The purpose of this study is to better understand the effects of low intensity focused ultrasound (FUS) on the central nervous system. Specific patient populations within UVA health system are undergoing treatment that provide unique opportunities to study these effects.

Focused ultrasound (FUS) at low intensities is a form of neuromodulation with high spatial resolution that can be applied invasively or non-invasively using acoustic energy to affect neuronal activity. In this study the investigators intended to use specific patient populations to investigate the effects of FUS on different areas of the central nervous system (CNS). Each of our patients groups is undergoing a unique procedure at University of Virginia that will provide us different insights into the CNS. (1) Patients receiving an awake or asleep craniotomy for brain tumors and/or epilepsy will undergo a brain mapping procedure using electrical stimulation as a part of their normal care. The research procedures will duplicate this mapping with an invasive FUS mapping. (2) Patients undergoing long term monitoring for epilepsy will receive a non-invasive form of FUS stimulation which will be measured by their EEG cap and intracranial electrodes which are a part of their normal care. (3) Patients undergoing high intensity FUS treatment for tremor will be asked to wear a research provided EEG cap while undergoing a non-invasive low intensity FUS research procedure and changes in their tremor will be monitored. (4) Patients undergoing Deep Brain Stimulation (DBS) treatment for tremor will receive a non-invasive FUS stimulation observed through their newly implanted electrode. (5) Patients receiving a spinal surgery will undergo a spinal stimulation using electrical stimulation as a part of their normal care. The research procedures will duplicate this with an invasive FUS stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Be a patient receiving a treatment or surgical procedure specified below:
* Receiving a Craniotomy with brain mapping
* Receiving treatment or monitoring for Epilepsy
* Receiving either FUS or DBS treatment for Tremor
* Receiving a Spinal Surgery for stimulator placement
* Able to provide informed consent
* Must speak English
* Age 18-85

Exclusion Criteria:

* Not receiving one of the specified inclusion procedures
* Unable to provide consent
* Women who self-report pregnancy
* Patients who are currently incarcerated
A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease

The primary aim of this study is allow the patients suffering from Crohn's disease , who both completed the therapeutic confirmatory study C87055 of certolizumab pegol and benefited from the treatment, to receive treatment with certolizumab pegol until the drug is available for the Crohn's disease indication in Greece.


Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease diagnosis
* Patients having completed the treatment period of study C87055 (previously treated with infliximab) and benefited from the study treatment, as per investigatior's discretion.

Exclusion Criteria:

* Subject withdrawn prematurely from C87055 study.
* Subject who received treatment other than certolizumab pegol and other than medications permitted in C87055 study.
* Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration.