cyrilzakka/clinical-trials huggingface dataset:
Use of GnRHa During Chemotherapy for Fertility Protection

Many cytotoxic drugs may harm the fertility of young women treated for cancer. The aim of the study is to investigate if the Gonadotropin-Releasing Hormone agonist (GnRHa) during cancer treatment can preserve the fertility of young female cancer subjects.

Approximately 300 women with newly diagnosed breast cancer and up to 200 women with newly diagnosed lymphoma, acute leukemias or sarcomas will be recruited before start of cancer treatment.

The patients will be randomised in between treatment with triptorelin (experimental) or placebo (control) intramuscularly a 1:1 ratio during chemotherapy. The injections may be given once monthly or once three months depending on type of chemotherapy given. Randomisation and study drug is blinded, neither investigator, research nurse nor patient will know if it is active drug or placebo. The only person who knows is the nurse preparing the injection.

Patients will be followed up to 5 years after end of treatment with physical examinations, vital signs, biochemical markers, bone mineral density exams, ultrasound for antral follicle counts and ovarian doppler flow, concomitant medications, adverse events and quality of life questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin) or sarcomas (osteo, soft tissue and Ewing) confirmed by histology and assigned for diseace-specific chemotheraphy
* Confirmed menarche
* ECOG performance status 0-1
* Adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders

Exclusion Criteria:

* Demonstrated premature ovarian failure at time of randomization according to clinical or biochemical data
* Previous or planned bilateral oophorectomy
* Pregnancy or breastfeeding at time of start of chemotherapy
* Other malignancy diagnosed within the last five years
* Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders including previous or current diagnosis of anorexia
* Known osteoporosis
* Known low platelet count with increased bleeding risk or refractory thrombocytopenia in subjects with acute leukemias
* Known or suspected allergy against triptorelin
* Direct radiation of the gonads previous or planned (TBI allowed)
* Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE

This is an open-label, single-dose, single-arm, single-center imaging study using DOTATATE peptide, labelled with the 64Cu tracer.

In total, 59 subjects will be recruited in the study. The study will recruit both healthy volunteers as well as patients with confirmed or suspicious NET disease by histology or conventional anatomical and functional imaging modalities including but not limited to magnetic resonance imaging (MRI), and/or computed tomography (CT), and/or, F-18 FDG fluorodeoxyglucose PET (positron emission tomography)/CT and /or F-18 NaF sodium fluoride bone PET/CT and/or bone scintigraphy, and/or Octreoscan.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed or suspicion of NET based on histology/ biopsy report.
* Confirmed or suspicion of NET based on conventional imaging scans of affected area such as MRI and/or contrast enhanced CT and/or an FDG PET
* CT scan and/or NaF PET-CT scan and/or OctreoScan® performed within 8 weeks prior to study date.

Exclusion Criteria:

* Pregnant, planning to be pregnant within the next two weeks
* Inability to provide written consent.
* Therapeutic use of any somatostatin analogue, including Sandostatin® long-acting and Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a subject is on Sandostatin® long-acting or Lanreotide, a wash-out period of 28 days is required before the injection of the study drug.
Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder

Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem. In previous studies, the investigators discovered that promoting the crawling of typical newborns on a mini skateboard, the Crawliskate (a new tool that the investigators designed and patented EP2974624A1), is an excellent way to stimulate infants' motor and locomotor development. This method is a promising way to provide early interventions in infants at heightened risk for developmental delay, such as premature infants.

The specific objective of this study is to determine if early training in crawling on this mini skateboard will accelerate motor (particularly locomotor) and/or neuropsychological development in very premature infants identified as high risk for developmental delay.

Methodology: The investigators will study and follow two groups of very premature infants born between 24 and 26 weeks of gestational age or born between 26 and 32 with major brain lesions.

These infants will be recruited before their hospital discharge at the NICU. After their discharge from the hospital, one group of infants will be trained at home by their parents under the supervision of physiotherapists to crawl on the Crawliskate every day for 2 months (Crawli group), and one group of infants will receive regular medical care (Control group). All infants will be tested for: 1)their crawling proficiency on the Crawliskate at term-equivalent age (just before training for the trained groups) and at 2 and 6 months corrected age (CA, i.e., age determined from the date on which they should have been born), 2) their motor proficiency between 2 and 12 months CA (2D and 3D recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 28 months CA: BSID III edition, ASQ-3, Amiel-Tison's Neurological Assessment, Prechtl Assessment of general movements. One more ASQ-3 questionnaire will be provided at five years.

Expected results: The first research hypothesis is that premature infants trained daily to crawl (for two months after discharge from the NICU) will acquire proficient crawling patterns and develop earlier and more effective motor and neuropsychological development than premature infants who receive no training.


Eligibility Criteria:
Inclusion Criteria:

* Term between 24-26 GA or 26-32 GA with suspected brain lesion
* parental consent
* family living in intervention area
* good tolerance on the first crawliskate trial

Exclusion Criteria:

* no bronchodysplasia defined by oxygen dependency after 36 GA
* no medical disease
* no limb deformity
* no karyotype anomaly
* no visual or auditory impairment
ICG Fluorescence Imaging in Open Fracture Trauma Patients

This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured by indocyanine green (ICG) fluorescence imaging, and complications, in an effort to develop ICG fluorescence imaging as a diagnostic tool to quantitatively guide operative debridement.

This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured using indocyanine green (ICG) fluorescence imaging, and complications. This will be used to develop ICG fluorescence imaging as a diagnostic tool to objectively and quantitatively guide operative debridement. The study population includes all open fracture patients regardless of race, ethnicity, or sex/gender. Primary outcome measure is all-cause re-operation and secondary outcome measure is surgical site infection. All patients will be followed for a total of 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or older.
2. Open extremity fracture.
3. Planned definitive fracture management with external fixation, internal fixation, or joint fusion.
4. Open fracture wound management that includes formal surgical debridement within 72 hours of their injury.
5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
6. Provision of informed consent.

Exclusion Criteria:

1. Inability of patient to provide informed consent
2. Fracture of the hand.
3. Iodine allergy.
4. Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic.
5. Open fracture managed outside of the participating orthopaedic service.
6. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
7. Burns at the fracture site.
Clonal Hematopoiesis of Indeterminate Potential in Venous Thromboembolism

The aim of the study is to investigate the existence of clonal hematopoiesis of indeterminate potential (CHIP) in patients with a history of venous thromboembolism.

The study investigators make the assumption that these patients present mutations involved in CHIP occurrence.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 50 years old who have consulted at the Hematology laboratory of the Nîmes University Hospital for the occurrence or history of venous thromboembolism
* Patient who has accepted that their DNA was kept and used in the context of research on venous thromboembolism (biobank (registration number DC-2008-290 and authorization number AC-2008-107))

Exclusion Criteria:

* Patients less than 50 years old
* Patient who has refused that their DNA was kept and used in the context of research on venous thromboembolism
Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal Insulin

The change of glycemic variation and insulin dose after adding SGLT2 inhibitor in type 2 diabetic patients treated with basal insulin was observed in a single center.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
2. Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study;
3. Patients had relatively constant diet and exercise in 2 month before the study.
4. Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose \<22.2mmol/L

Exclusion Criteria:

1. Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;
2. Patients with severe infectious diseases;
3. Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
4. Patients with history of psychiatric disorders and were unsuitable to use CGMS;
5. Patients used GLP-1 analogues，SGLT2 or more than once insulin injection in the past 3 months
6. Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.
Role and Outcome of Endovascular Revascularization of Chronic Limb Ischaemia

identify the safety and efficacy of percutaneous transluminal angioplasty in critical limb ischaemia patients with chronic kidney dieases

patients with chronic kidney diseases are at higher risk of developing peripheral artery diseases needing revascularization of diseased arteries via endovascular transluminal angioplasty

Eligibility Criteria:
Inclusion Criteria:

* all patients with chronic kidney diseases on medical treatment or on dialysis and have critical limb ischaemia

Exclusion Criteria:

* patients with acute renal failure and lower limb ischaemia.
* chronic kidney diseased patients underwent previous intervention or surgery for lower limb ischaemia.
* patients presented with acute limb ischaemia
The Predictive Scores for Gastric Cancer in Gastric Intestinal Metaplasia (GIM) Patient: a Recommendation for Thai Population

The predictive scores for gastric cancer in gastric intestinal metaplasia(GIM) patient: a recommendation for Thai population.

Objective:

To evaluate major risk factors for gastric cancer in gastric intestinal metaplasia(GIM) patient in order to propose the appropriate recommendation for Thai people.

Research Design:

Single center, retrospective-cohort study.

Study population and Sample size at Faculty of Medicine, Chulalongkorn University The patients who were diagnosed gastric intestinal metaplasia from 1997 to 2012 and then follow up for 5 years. Estimate sample size =280

* Investigational product, dosage \& route of administration
* Questionnaire for explore the risk factors
* EGD with biopsy
* Blood sampling for gastro panel
* Duration of participation
* 5 years or until diagnose gastric cancer

Statistical method:

Unconditional-binary-logistic regression

Eligibility Criteria:
Inclusion Criteria:

1. All patients were diagnosed GIM
2. All patients have to sign the consent form

Exclusion Criteria:

1. Previous gastric surgery including gastrectomy and bypass surgery
2. Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
3. HIV infection
4. History of proton pump inhibitor use within 1 week
5. History of antibiotic use within 4 weeks
Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)

The purpose of this study is to evaluate long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) following lung transplantation (LTx) in patients previously enrolled in phase II/III L-CsA clinical trial 12011.201.

This is an uncontrolled extension study open only to patients who completed the Phase II/III core study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy.

Determination of long-term safety and efficacy outcome over a maximum of three years will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has completed the L-CsA clinical trial 12011.201
2. Patient is capable of understanding the purpose and risks of the follow-up study, has been fully informed and has given written informed consent to participate in the study
3. Female patients of child bearing potential must test negative on standard urine pregnancy test prior to continuation and must agree to practice effective birth control during the study
4. Estimated life expectancy \> 6 months
5. Capable of self-administration of medications
6. Patient has stable creatinine levels

Exclusion Criteria:

1. Patients with ongoing irreversible L-CsA related serious adverse events
2. Patients with known hypersensitivity for ciclosporin A
3. Patient intends to participate in another IMP clinical trial other than listed in the inclusion criteria
4. Patient receives mechanical ventilation
5. Patients underwent pulmonary re-transplantation
6. Patient is a pregnant or breast-feeding woman
7. Patient is unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol
8. Patient receives any systemic or topical Rosuvastatin
9. Patient has been previously enrolled in this study
10. Patient with malignancy diagnosed during study 12011.201 (with the exception of skin cancer)
11. Documented respiratory infections unless on appropriate antimicrobial therapy with evidence of clinical response
12. Patient is not eligible to continue IMP inhalation according to the Investigator's discretion
Serum Cholinesterase Level in Aluminum Phosphide Poisoning, the Possible Proposing Role of Atropin & Pralidoxime

Metal phosphides are widely used as a rodenticide and insecticide and poisoning with these substances has a very high mortality. The aim of this study was to evaluate the butyrylcholinesterase (BuCh) level in poisoning with metal phosphides.

Today, the use of pesticides in the world is considered as a recognized health It is estimated that around 30% of global suicides are due to pesticide self-poisoning . Metal phosphides pesticides are highly toxic, low cost, and are easily accessible as rodenticide agents and used for self-poisoning . aluminum phosphide (ALP) are among the most important metal phosphides. Poisoning with these agents is frequently seen in India, Srilanka and Iran. In a recent study, the incidence of fatal aluminum phosphide poisoning cases referred for phosphine analysis was 5.22 and 37.02 per million of population of Tehran, Iran in 2006 and 2013, respectively (9).The mechanism of toxicity is not clearly defined. ALP toxicity is related to the production of phosphine gas. Phosphine inhibits cytochrome c oxidase and causes mitochondrial destruction and inhibits oxidative respiration which leads to anaerobic metabolism, severe metabolic acidosis, multi-organ dysfunction and death. Phosphine can lead to severe cardiac suppression and cardiogenic shock. One of the proposed mechanisms of toxicity is the reduction of the true cholinesterase and serum cholinesterase (butyrylcholinesterase) enzyme, but usually do not show obvious clinical manifestations .

Eligibility Criteria:
Inclusion Criteria: cases of aluminum phosphide poisoning -

Exclusion Criteria: concomitant ingestion

-
Effectiveness of Integrated Network for Student Psychosocial Intervention, Resilience, and Education (INSPIRE) on Mental Health Outcomes Among Indonesian Adolescents in Bandung

The INSPIRE (Integrated Network for Student Psychosocial Intervention, Resilience, and Education) intervention is an 8-week, school-based mental health program designed to enhance adolescents' mental health literacy and resilience while addressing symptoms of depression and anxiety. Implementation is conducted by school counselors who undergo an intensive two-day training program. The intervention is supported by comprehensive curriculum materials including detailed lesson plans, activities, discussion prompts, and instructional slides featuring key concepts, visuals, and explanatory content. Supplementary materials are developed for both participating adolescents and their parents.

The study aims to:

1. Evaluate the usability and feasibility of the INSPIRE intervention within the school environment.
2. Assess the intervention's effectiveness in improving:

   * Primary outcome: Mental health knowledge among adolescents
   * Secondary outcomes: Attitudes toward mental health, help-seeking behaviors, mental health literacy, resilience, and symptoms of depression and anxiety among adolescents
   * Secondary outcomes: mental health knowledge, attitudes, help-seeking behaviors, and mental health literacy among parents
3. Explore the experiences of intervention participants (both adolescents and parents) against the control group to develop comprehensive insights into the psychosocial intervention's impact.

The research hypothesis proposes that the INSPIRE intervention group will demonstrate significantly higher scores in mental health knowledge, more positive attitudes toward mental health, increased help-seeking behaviors, enhanced mental health literacy, and greater resilience, while simultaneously showing reduced symptoms of depression and anxiety compared to the control group receiving standard care. These outcomes will be measured immediately following the intervention (post-test 1) and at one-month follow-up (post-test 2).


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria for adolescents are as follows:

* Unmarried, 13-15 years old, school-going, healthy adolescents enrolled in an Indonesian public junior high school
* Able to read, understand, and converse in Bahasa Indonesia.

The inclusion criteria for parents are as follows:

* The biological father, mother, or an adult who fulfils a parental or guardian role for the participating adolescent
* Able to understand and communicate in Bahasa Indonesia.

Exclusion Criteria:

* Adolescents who are working, clinically diagnosed with severe mental disorders, such as schizophrenia or psychosis, at high risk for mental health disorders (e.g., teenage pregnancy), or are cognitively impaired will be excluded.
* Parents with severe mental disorders or cognitive impairment that may hinder participation will be excluded.
Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.


Eligibility Criteria:
Key Inclusion Criteria:

* The patient has completed 8 weeks of treatment in a Cephalon-sponsored Phase 3, double-blind study of armodafinil treatment in patients with major depression associated with bipolar I disorder.
* The patient met criteria for enrollment in the previous double-blind study and, in the opinion of the investigator, is in need of continued treatment for depression.
* During the previous double-blind study, the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium; valproic acid; olanzapine; quetiapine; aripiprazole; lamotrigine; risperidone; ziprasidone, (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:

  1. The mood stabilizers must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.
  2. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.
  3. The patient must be judged by the investigator to be compliant with treatment with the mood stabilizer(s).
  4. The patient must be willing to continue treatment with the same protocol-allowed mood stabilizer(s) at dosages considered appropriate by the investigator.
* The patient has a Young Mania Rating Scale (YMRS) total score of 14 or less at the enrollment visit. Patients who have a YMRS score of 12 through 14 must be discussed with the medical monitor to determine their suitability for enrollment.

Key Exclusion Criteria:

* The patient has any Axis I or Axis II disorder apart from bipolar I disorder that became the primary focus of treatment during the double-blind study.
* The patient has psychotic symptoms or had psychosis during the double-blind study.
* The patient has current active suicidal ideation, is at imminent risk of self harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
* The patient met criteria for alcohol or substance abuse or dependence (with the exception of nicotine dependence) during the double-blind study.
* The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation.