cyrilzakka/clinical-trials huggingface dataset:
Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors

This study is being conducted to find out whether lacosamide (a drug to treat epilepsy) is effective in routine clinical practice for patients with epilepsy caused by a brain tumor.


Eligibility Criteria:
Inclusion Criteria:

* Patient has never been treated with lacosamide (LCM) prior to this non-interventional study (NIS) or treatment with LCM for the first time started no earlier than 7 days prior to enrollment in this NIS
* The decision by the treating physician to prescribe LCM falls within current standard clinical practice, and the treatment decision is clearly separated from the decision to consider inclusion of the patient in the NIS
* A Patient Data Consent form is signed and dated by the patient and/or by the parent(s) or legal representative
* Patient is a male or female ≥ 16 years of age
* Patient must have a diagnosis of brain tumor-related epilepsy (BTRE) secondary to low-grade glioma (World Health Organization Grade 1 to 2 at time of enrollment)
* Patient has a retrospective Baseline seizure frequency of at least 1 partial-onset seizure in the 8 weeks prior to Visit 1 (enrollment/ Baseline visit)
* Patient does not have a previous diagnosis of epilepsy before tumor onset
* Patient does not have brain metastases
* Patient has a Karnofsky performance status scale index ≥ 60 %
* Patient is currently taking only 1-2 Baseline anti-epileptic drugs (AEDs) for epilepsy, other than LCM
* Patient has received a maximum of 4 different lifetime AEDs ever before entering the NIS

Exclusion Criteria:

* N/A
Performance of 2WIN Photoscreener With Corneal Reflex Compared to School Bus Retinoscopy by AAPOS Guidelines

Pediatric eye patients receive infrared photoscreener screening and skiascopy as a part of routine examination to compare ability to detect amblyopia risk factors.

Patients: Pediatric eye and adult strabismus patients undergoing routine examinations in a private ophthalmology practice.

Interventions: Infrared photoscreener / remote autorefractor such as 2 Winner (2WIN) ("Adaptica" - Padova, Italy) without and with infrared corneal reflex occluder. Child-friendly skiascopy before and after cycloplegic refraction.

Outcome: Amblyopia Risk Factors from comprehensive eye exam including refraction and strabismus.

Risk factors defined by American Association for Pediatric Ophthalmology and Strabismus (AAPOS) 2003 and 2013 guidelines.

\*\*Please note that 2 Winner has nothing to do with actual device, but was required by the Clinical Trials Web entry.\*\*

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing eye examination

Exclusion Criteria:

* none
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)

Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.

Brochopulmonary dysplasia is a severe chronic lung disease in extremely preterm infants. The morbidity of BPD is increasing in CHINA. The preventive and therapy methods of BPD are still lacking.

Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD). A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.

Eligibility Criteria:
Inclusion Criteria:

* Extremely preterm infants who remain on mechanic ventilator after 2 weeks of postnatal age
* Extremely preterm infants with a X-ray sign of BPD after 2 weeks of postnatal age

Exclusion Criteria:

* Patients with severe congenital diseases
* Patients with IVH more than 3 grade
* Patients with severe sepsis
* Patients with active pulmonary hemorrhage
Comparing Two Medical Treatments for Early Pregnancy Failure.

This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol) are superior compared to using only one of these drugs (Misoprostol) as medical treatment for a miscarriage. Women in whom early pregnancy failure, 6-14 weeks postmenstrual, is ultrasonographically confirmed qualify for this study.

It is expected that the combination of Mifepristone and Misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.

This study will test the hypothesis that, in early pregnancy failure, the sequential combination of mifepristone with misoprostol is superior to the use of misoprostol alone in terms of complete evacuation of products of conception (primary outcome), patient satisfaction, complications, side effects and costs (secondary outcomes). The trial will be performed multi-centred (hospitals), prospectively, two-armed, randomized, double-blinded and placebo-controlled.

Women with ultrasonographically confirmed early pregnancy failure (6-14 weeks postmenstrual), managed expectantly for at least one week, can be included. Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients will be randomized to oral mifepristone (600mg) or oral placebo (identical in appearance). The investigators aim to randomize 460 women in a 1:1 ratio, stratified by centre.

After six weeks, the primary endpoint, complete or incomplete evacuation, will be determined

Eligibility Criteria:
Inclusion Criteria:

Early pregnancy failure, 6-14 weeks postmenstrual with

* a crown-rump length ≥ 6mm and no cardiac activity OR
* a crown-rump length \<6mm and no fetal growth at least one week later OR
* a gestational sac with absent embryonic pole for at least one week.

  * At least one week after diagnosis OR a discrepancy of at least one week between crown-rump length and calendar gestational age
  * Intra-uterine pregnancy
  * Women aged above 16 years
  * Hemodynamic stable patient
  * No signs of infection
  * No signs of incomplete abortion
  * No contraindications for mifepristone or misoprostol

Exclusion Criteria:

* Patient does not meet inclusion criteria, discovered after randomization
* Inability to give informed consent
* Known clotting disorder or use of anticoagulants
* Known risk factors for, or presence of, a cardiovascular disease
* Language barrier
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.


Eligibility Criteria:
Inclusion Criteria:

* Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.

OR

* Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
* Ambulatory male and female children and adolescents, age 5 to \<18 years, including ambulatory with assistance as defined in the pediatric osteogenesis imperfecta (OI) population.
* Clinical diagnosis of OI, defined as clinical history consistent with type I, III, or IV OI as determined by presence of expected phenotype (examples include: facial shape, voice, blue sclera, dentinogenesis imperfecta, typical radiographic features, fracture pattern) and lack of additional features unrelated to type I, III, or IV OI (eg, blindness, mental retardation, neuropathy, and craniosynostosis).

  o If familial, also must be autosomal dominant.
* Meets at least one of the following:

  * 3 or more fractures within the previous 2 years, or
  * 1 or more nonvertebral fracture(s) within the previous 2 years and at least 1 prevalent vertebral fracture, or
  * 2 or more prevalent vertebral fractures.

Exclusion Criteria:

Disease Related

* History of an electrophoresis pattern inconsistent with type I, III or IV OI.
* History of known mutation in a gene other than collagen type I alpha 1/collagen type I alpha 2 (COL1A1/COL1A2) causing OI or other metabolic bone disease.
* History of congenital dislocation of the radial head, interosseous membrane calcification, or exuberant callus formation.
A Qualitative Study About Smoking Practices

This study involves in-depth interviews with parents of urban children with asthma and focus groups with additional parents in order to understand their attitudes and beliefs about smoking.


Eligibility Criteria:
Inclusion Criteria:

* Child with asthma
* Parents being current smokers, ex-smokers, or non-smokers

Exclusion Criteria:

* Non-English speaking families
Clinical Study to Evaluate Efficacy and Safety of ANT-301 in Patients with Knee Osteoarthritis in Grade III/IV by K/L

This is a phase I open study to evaluate the efficacy and safety of ANT-301 in patients with knee osteoarthritis K\&L Grade III/IV.

Study Design: open-label, single-center, dose-escalation study

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been provided with information about the clinical trial and have provided written consent on the informed consent form
2. Patients aged 19 to 70 years old.
3. Patients diagnosed with K\&L grade III/IV knee osteoarthritis
4. Patients with a VAS pain score of 40mm or higher when measured on a 100-point scale

Exclusion Criteria:

1. Patients with joint diseases other than osteoarthritis
2. Patients who have undergone knee joint surgery or radiation therapy to the knee joint within 6 months prior to the screening
3. Patients who received intra-articular injections within 6 months prior to the screening
4. Patients who have received systemic steroid therapy within 3 months prior to the screening
5. Patients who have received immunosuppressive agents within 3 months prior to the screening
6. Patients who have received cell therapy or gene therapy to the target knee within 5 years prior to the screening
7. Patients who are unwilling to use contraception during the clinical trial period
European Multicentre Study of Human Spinal Cord Injury

Today there is accumulating evidence from animal experiments that regeneration can be induced after a spinal cord injury (SCI). Consequently in the near future, new therapeutic approaches to induce some regeneration will be included in the treatment of patients with SCI. The aim of this proposal is to provide the required clinical basis for the implementation of novel interventional therapies. The establishment of combined clinical, functional and neurophysiological measures for a qualitative and quantitative assessment of spinal cord function in patients with SCI at different stages during rehabilitation represents a basic requirement to monitor any significant effect of a new treatment. Therefore, several European Paraplegic Centres involved in the rehabilitation of acute traumatic SCI patients build up a close collaboration for standardised assessment. The aim is to get knowledge about the natural recovery after spinal cord lesion in a larger population of patients in the sense of a historical control group and to bring new standardised assessment tools to the clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Single event traumatic or ischemic para- or tetraplegia
* First EMSCI assessment possible within the first 6 weeks after incidence
* Patient capable and willing of giving written informed consent

Exclusion Criteria:

* Nontraumatic para- or tetraplegia (i.e. discusprolaps, tumor, AV-malformation, myelitis) excl. single event ischemic incidences
* Pre-known dementia or severe reduction of intelligence, leading to reduced capabilities of cooperation or giving consent
* Peripheral nerve lesions above the level of lesion (i.e. plexus brachialis impairment)
* Pre-known polyneuropathy
* Severe craniocerebral injury
Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder

Children and adolescents with early-onset bipolar disorder (BD) are at high risk for intentionally hurting themselves. Although there are therapies in existence for these youths with BD, they do not address suicide prevention specifically. Mentalization-based therapy for adolescents (MBT-A) has been shown to be helpful in reducing self-harm in the adolescent and adult population with borderline personality disorder. The investigators will modify the MBT-A treatment procedures for persons with BD who have had a recent period of suicidal ideation or behavior.

Youth with early-onset bipolar disorder (BD) are at an elevated risk for intentional self-harm compared to healthy adolescents or adolescents with other psychiatric disorders. Adolescents vulnerable to emotion dysregulation and self-harm often have deficits in the ability to mentalize: to understand, acknowledge, and predict thoughts and feelings in oneself and others. Mentalization-based therapy for adolescents (MBT-A) has been shown to be more effective than 'usual care' in reducing self-harm for adolescents and adults with borderline personality disorder. MBT-A includes psychoeducational and coping strategies that may prove quite effective for bipolar adolescents who are at elevated risk for self-harm.

Participation in this study will last 9 months. All participants will receive a thorough medical-psychiatric evaluation. All youth will be able to receive pharmacotherapy with a study psychiatrist in the CHAMP clinic. The MBT-A will consist of up to 21 weekly, biweekly and monthly individual sessions interspersed with 9 monthly family sessions (30 therapy hours total). Participants will also complete follow-up assessments every 3 months for 9 months. These assessments will include research interviews and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Bipolar Disorder I, Bipolar Disorder II, or Bipolar Disorder Not Otherwise Specified
* Living with or in close contact with at least one parent who is willing to participate
* Have had at least 1 week in the prior 3 months of significant suicidal ideation and/or at least one suicidal event in the 3 months prior to study intake.
* Willing to be treated pharmacologically by a psychiatrist in the UCLA Child and Adolescent Mood Disorders (CHAMP) clinic

Exclusion Criteria:

* Participants requiring immediate hospitalization
* Diagnosis of borderline personality disorder, schizophrenia, or schizoaffective disorder.
* Current substance dependence disorder
Determinants of Fat Malabsorption After Roux-en-Y Gastric Bypass

The purpose of this study is to determine whether or not the length of the biliopancreatic limb of the Roux-en-Y anastamosis plays a critical role in the development of malabsorption after gastric bypass for treatment of severe obesity.

Successful surgical treatment of severe obesity by RYGB is believed to require a procedure that (a) restricts the consumption of combustible food energy, and (b) reduces the intestinal absorption of food energy that is consumed. However, with RYGB operations that are currently employed, many patients do not develop the malabsorption they presumably require to produce good long term control of their body weight. It is important to find a way to do RYGB surgery in a way that consistently produces a moderate degree of fat malabsorption.

Patients who are scheduled to receive a RYGB for treatment of severe obesity will be randomly assigned to receive 2 variations of the standard operation. The stomach and duodenal bypass, and the creation of a small gastric pouch will be exactly the same for all patients. There will be differences in the two jejunal limbs which create the Roux-en-Y anastomosis. In Procedure A, the Roux limb length will be 150 cm, and the biliopancreatic limb will contain 40 cm of jejunum. In Procedure B, the Roux limb length will be 110 cm and the biliopancreatic limb will contain 80 cm of jejunum. The total length of jejunum in both limbs is 190 cm in both procedures. Thus, the only difference between procedures A and B is that B procedure has a larger percentage of jejunum in the biliopancreatic limb (80/190=42%) than procedure A (40/190 = 21%). A total of 20 patients will be studied, 10 with each procedure. Before and after RYGB, the patients will be studied in a clinical research laboratory. Dietary intake and intestinal absorption of fat, protein, carbohydrate and combustible energy will be measured by metabolic balance techniques for 72 hours. We hypothesize that fat malabsorption after bypass will be greater and more consistent in patients who receive the longer biliopancreatic limb than in the patients who receive the longer Roux limb.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe obesity (BMI equal to or greater than 50) who have been scheduled to receive Roux-en-Y gastric bypass.

Exclusion Criteria:

* Previous abdominal surgery, chronic diarrhea, and severe constipation.
Clopidogrel Versus Ticagrelor in Type-2 Diabetes

CLOTILDIA is a single-center, prospective, randomized, open label, cross-over study evaluating the effects of ticagrelor versus high-dose clopidogrel on endothelial function and platelet reactivity in patients with type-2 diabetes mellitus (T2DM) treated with percutaneous coronary intervention (PCI).


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* stable coronary disease
* coronary revascularization with PCI at least 1 month prior to recruitment

Exclusion Criteria:

* acute coronary syndrome
* platelet count \<70x109/l
* active bleeding or bleeding diathesis
* history of intracranial bleeding
* gastrointestinal bleeding \<6 months
* cerebrovascular accident \<3 months
* history of malignancy
* concomitant need for oral anticoagulant therapy
* severe liver disease or chronic renal failure (glomerular filtration rate \<30 ml/min /1.73m2)
Turkish Validity and Reliability Study of The Bipolar Recovery Questionnaire

In addition to objective criteria (no episode period for 6 months) for defining and monitoring recovery, evaluation of subjective criteria is also very important. Various Turkish scales related to recovery in progressive diseases have been developed or validity-reliability studies have been conducted. However, as far as we know, there is no scale that evaluates subjective improvement for a disorder such as bipolar disorder that progresses in episodes and has a heterogeneous appearance of loss of functionality. In this study, we aimed to conduct a validity and reliability study of the recovery questionnaire for BDD.


Eligibility Criteria:
Inclusion Criteria:

* Being between 18-65 ages
* Be diagnosed with bipolar affective disorder
* Be at least primary school graduate

Exclusion Criteria:

* having a physical disability (blindness, etc.) that might prevent filling in the scales,
* having an additional neurological disease that prevented filling out the scale items.
The Prognostic Capabilities Of A Preoperative Six-Minute Walk Test To Independently Inform Cardiovascular Risk After Major Noncardiac Surgery

This prospective cohort study aims to determine whether the addition of the 6MWT to the RCRI score improves the risk prediction of postoperative cardiovascular outcomes after noncardiac surgery. In addition, this study will assess whether the patients' reported MET score corresponds to the determined MET score from the 6MWT distance completed.

Study investigators propose to undertake a prospective cohort study at the preoperative clinics of the Royal-Victoria and Montreal General Hospitals of McGill University Health Centre. All patients with planned noncardiac surgery under general or regional anesthesia will be considered for inclusion.

Eligible consenting patients will undergo the 6MWT during their preoperative clinical visit, typically occurring within a few weeks before surgery. This test will be performed by a trained health care worker. Patients will walk back and forth along a 20 m corridor, while attempting to cover as much ground as possible in 6 minutes. Patients will be allowed to rest on the chairs while performing the test if necessary. Patients will be encouraged to resume walking as soon as patients feel physically able. The total covered distance in 6 minutes will be measured to the nearest meter.

The RCRI score will be calculated for each study participant.

Eligibility Criteria:
Inclusion Criteria:

All patients fulfilling all the following inclusion criteria will be enrolled:

* Patients aged ≥ 50 year old and undergoing elective noncardiac surgery, under general anesthesia or regional anesthesia.
* Patients with planned surgery within 3 months of the preoperative visit.

Patients with at least one of the following medical conditions:

* Hypertension, diabetes mellitus, dyslipidemia, coronary artery disease, chronic kidney disease, transient ischemic attack, stroke, or peripheral vascular disease.

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded:

* Patients with a condition preventing mobilization for 6 minutes.
* Patients with significant cardiac disease (e.g., low-threshold angina (angina that occurs with minimal exertion), severe aortic stenosis).
* Patients with severe pulmonary disease restricting mobility.
* Patients refusing to participate.
* Patients previously enrolled in the study.