cyrilzakka/clinical-trials huggingface dataset:
Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury

This study is testing the usefulness of two types of Brain Health \& Wellness classes for Veterans with a history of concussion to improve mental health.

This is a pragmatic, randomized controlled trial of Mindfulness-based Stress Reduction (MBSR) in 120 Veterans with comorbid PTSD and chronic mTBI. Half of the participants are randomly assigned to MBSR and the other half, to a Brain Health education class, which serves as an active control group. A battery of standardized psychological and cognitive measures are administered prior to and following the class interventions to assess change in response to the intervention, with an additional 6-month follow-up assessment to test for lasting changes. The primary outcome measures include the Mayo-Portland Adaptability Inventory IV (functional outcome), PTSD Checklist (psychological outcome), and cognitive control test (cognitive outcome).

Eligibility Criteria:
Inclusion criteria:

* 18-75 years old
* chronic history (\>6 months) of one or more mTBIs
* current diagnosis of PTSD
* at least one self-reported cognitive symptom

Exclusion criteria:

* no history of other neurologic disease (e.g., tumor, stroke, dementia, Parkinson's)
* no history of major brain surgery
* no history of moderate or severe TBI
* no active alcohol or drug dependence or abuse within previous 30 days
* no history of severe psychotic disorder (e.g., schizophrenia)
* no current suicidal ideation/risk
* no clinically severe medical illness requiring treatment
Analgesia for Thyroidectomy Using Bilateral Superficial Cervical Plexus Block With Bupivacaine Only or Adding Ketorolac to it.

Thyroidectomy is considered a common operation with moderate to severe postoperative pain in some patients. Patients are divided into two groups. Bupivacaine group received bilateral superficial cervical plexus block (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of normal saline on each side and the Bupivacaine Ketorolac group received (BSCPB) with 10 ml of bupivacaine (0.25%) and 1 ml of ketorolac (15 mg) on each side.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-50 years
* ASA I-II patients
* Patients going to do thyroid surgeries under general anesthesia

Exclusion Criteria:

* Patient refusal
* Known history of sensitivity to the drug used in the study
* Drug abuse
* Infection at the site of the block
* Presence of coagulopathy
Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome

To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.

To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy. The hormonal response of the hypothalamic-pituitary-gonad axis was assessed after pulsatile GnRH replacement by measurement of serum T, LH and FSH. A standard seminal fluid analysis was performed in men who could produce an ejaculate.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or over male patients;
* Absent or incomplete puberty development;
* Serum testosterone values below 3.47 nmol/L by low or normal serum LH and FSH concentrations.
* at least two or more pituitary hormone deficiencies
* Brain MRI showed absent and thin pituitary stalk, or pituitary hypoplasia and/or ectopic posterior pituitary.

Exclusion Criteria:

* cryptorchidism history
* other causes of hypopituitarism or severe systemic disease
Artificial Intelligent System for Eye Emergency Triage and Primary Diagnosis

Ophthalmic emergencies are acute vision-threatening disorders, for which a delay in prompt emergency response could result in catastrophic vision loss. Triage is an effective process for ensuring that timely emergency care is provided despite limited resource by prioritizing patients to appropriate orders for visits. Historically, registered nurses classify emergency patients based on personal experiences with high variation. Additionally, primary healthcare providers have been conventionally at the forefront of providing first aid care. However, most of ocular emergencies are wrongly diagnosed or referred due to non-eye specialists' limited knowledge and training in the ophthalmology.

Here, the investigators established and validated an artificial intelligence system, EE-Explorer, to triage eye emergencies and assist in primary diagnosis using metadata and ocular images. This system has been integrated into a website to be prospectively validated in the real world.


Eligibility Criteria:
Inclusion Criteria:

1. Suffering acute ophthalmic symptoms within one month
2. Visiting the ocular emergency department for the first time
3. Must be able to complete the triage form for ophthalmic emergency
4. Must be able to cooperate either by submitting smartphone photographs or receiving slit-lamp examination

Exclusion Criteria:

The image quality does not meet the clinical requirements.
Effect of Hyaluronidase on Intraocular Pressure

The aim of this study is to evaluate effect of retrobulbar local anaesthesia after addition of hyaluronidase on IOP during cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* 1-Patients above the age of 50 years. 2-Patients with age related cataract. 3-Normal IOP.

Exclusion Criteria:

* 1History of trauma. 2-Patients with glaucoma. 3-Previous ocular surgery. 4-Patients with other ocular pathology. 5-Uncontrolled diabetes or hypertension. 6-hypersensitivity to lignocaine. 7-Uncooperative or epileptic patients.
Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers

The goal is to establish the safety of administration of nasal foralumab to healthy volunteers in escalating doses to determine the dose at which immune effects are observed. Patients will receive doses for 5 consecutive days and have a follow-up period.

This was a randomized, double blind phase 1 dose escalation study evaluating 3 dose levels of foralumab via intranasal administration from single-dose vials. The rationale behind the proposed research was to establish an immunologically active dose of foralumab given by the nasal route. Given that foralumab has never been administered by the nasal route to humans, this was a safety and dose finding study. Each dose group was observed until Day 7 to assess safety before moving to the next higher dose. This study also helped determine the dose at which immune effects (induction of regulatory T cells and changes in cytokine profiles of immune cells) were observed in subjects treated with foralumab.

Eligibility Criteria:
Inclusion Criteria:

* Men or women ages 18 to 65 years
* Healthy adults
* Ability and willingness to provide informed consent and comply with study requirements and procedures

Exclusion Criteria:

* Chronic medical disease compromising organ function
* Corticosteroids within the past month
* Pregnancy or lactating
* Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, thyroid disease, or type I diabetes
* Chronic rhinitis, deviated septum, nasal polyps, history of sinusitis treated within the past year.
* Participation in another clinical trial within the past 30 days
* Known history of drug or ETOH abuse
* Screening labs outside of the normal range; EBV IgM positive subjects with clinical signs will not receive study drug
* Nasal corticosteroids; antihistamines; nasal flu dosing within 30 days
Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy

This study is designed to assess effectiveness, safety and cost-utility of conventional rehabilitation and traditional Korean medicine conjugated rehabilitation on children with cerebral palsy.

1. Survey

   1. An interview survey on baseline

      * Basic characteristics
      * Cause of cerebral palsy
      * Accompanied disorders
      * Health problems
      * Operation history
      * Drug-taking
      * Rehabilitation treatment
      * Korean medicine treatment
      * Health functional food
      * Medical care cost
   2. An interview survey on 26th and 52nd weeks

      * Accompanied disorders
      * Health problems
   3. A weekly tracking survey

      * Health problems
      * Therapeutic change
      * Medical care cost
      * Quality of life
2. Assessment for function development on baseline, 26th and 52nd weeks

   * Gross Motor Function Classification System (GMFCS)
   * Gross Motor Function Measure-66 (GMFM-66)
   * Pediatric Evaluation of Disability Inventory (PEDI)

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy
* Age from 6 to 78 months
* whose guardian consent to the present study

Exclusion Criteria:

* who had an orthopedic operation due to cerebral palsy
* who has congenital muscular disease, hereditary disease, or progressive central nervous system diseases
* who suffers from severe diseases (ie, cancer, severe heart disease, severe infectious disease)
Evaluation of Volume Status, Haemodynamics and Microcirculatory Flow in Adult Patients With Severe Falciparum Malaria

acidosis, acute renal failure and acute pulmonary oedema are common, and frequently fatal, manifestations of severe P. falciparum malaria. The course of all three might be ameliorated by optimising a patient's intravenous fluid therapy. The fluid treatment of severe malaria is presently empirical, by defining cardiovascular responses to volume replacement we would provide a physiological basis for resuscitation strategies.

We will use pulse contour cardiac output monitoring (PiCCOTM) to guide the fluid resuscitation of patients admitted to intensive care with severe malaria. With data collected during the patients' admission we hope to:

1. Assess the degree of hypovolaemia in adults with severe malaria and its contribution to microcirculatory dysfunction and acidosis.
2. To assess the relationships between volume status, haemodynamic parameters and the renal and pulmonary manifestations of severe malaria.
3. To assess the utility of central venous pressure measurement as a guide for fluid administration in patients with severe malaria
4. To investigate the prognostic and clinical utility of central venous oxygen saturation in severe malaria

In this way we hope to develop a greater understanding of the pathophysiology of haemodynamic derangement in severe malaria. By comparing the PiCCO derived data with simpler clinical parameters, we hope to determine potential fluid resuscitation strategies - relevant for a resource poor setting - whose efficacy could be confirmed in future trials.


Eligibility Criteria:
Inclusion Criteria

1. Severe malaria, defined by the modified criteria of Hien et al and the presence of asexual forms of P. falciparum in the peripheral blood smear.
2. The patients or their attending relative able and willing to give fully informed written consent.
3. Age ≥ 16 years

Exclusion Criteria

1. Patients or relatives unable or unwilling to give informed consent.
Efficacy of Clinical Application of Transcranial Low Intensity Focused Ultrasonic Stimulation for Patients With Major Deperessive Disorder - Exploratory Clinical Trial

The non-invasive type ultrasonography system is applied to patients with major depressive disorder to evaluate their effectiveness and safety. Brain Computer Tomography(CT) and Magnetic Resonance Image(MRI) are taken to induce images before transcranial low intensity focused ultrasonic stimulation.

Through random extraction, the group is divided into treatment group and placebo group. The treatment is started by targeting left Dorsolateral prefrontal cortex(DLPFC) region according to assigned groups. As for women, considering mood change during menstrual cycle, the treatment is taken place 1 week after the menstruation has initiated. The treatment group and the placebo group will be treated three times a week for two weeks.

To evaluate clinical symptoms, Quick Inventory of Depressive Symptomatology-Self Report, Scale for Suicidal Ideation, state-trait anxiety scale, frontal lobe management function test, memory test, and continuous performance test are performed before, during, and after treatment. For the assessment of side effects, Systematic Asseseement for Treatment Emergent Events-General Inquiry(SAFTEE) are conducted for treatment presentation events every week during the treatment implementation period and every two weeks after the treatment is completed.


Eligibility Criteria:
Inclusion Criteria:

1)19 to 60 years of age 2)Having major depressive disorder without psychotic feature according to the DSM-5 diagnosis criteria SCID-5-CV: (ICD-10 code : F32.0, F32.1, F32.2, F33.0, F33.1, F33.2) 3)Montgomery-Asberg Depression Rating Scale (MADRS) score ≥12 4)No history of suicidal attempt with suicidal ideation tendency score assessed by the Scale for Suicide Ideation (SSI) ≤ 9 5)No antidepressants regimen for 4 weeks prior to enrollment. 6)n the case of active antidepressants regimen, patients with MADRS score ≥12 and who will not change their medication doses during the study period

Exclusion Criteria:

* Incompatibility with brain CT and MRI
* Disorders that may cause depression (e.g., thyroid dysfunction, uncontrolled diabetes) or who taking medications that can influence on mood (e.g., thyroid hormones, steroids.)
* History of epileptic seizures
* History of major psychiatric disorder including schizophrenia and bipolar disorder
* Mental retardation
* Severe physical illness including cancer and tuberculosis
* Significant skin problems including contact dermatitis
* Pregnant women or women planning to become pregnant
* (After CT scan) skull thickness ≥ 8, or significant calcification
* (After MRI scan) structural abnormalities such as brain tumors, hemorrhage, traumatic brain disease, or structural changes due to degenerative brain disorders
Enucleation of Pancreatic Tumor by Blocking Abdominal Trunk and Superior Mesenteric Artery

Pancreatic enucleation could preserve more healthy pancreatic tissues and functions with a low recurrence risk. However, conventional enucleation can cause significant intraoperative bleeding, especially in which tumors in the pancreatic head, neck, and uncinate process of pancreas, as these tissues are rich in blood supply, mainly including the abdominal trunk and the superior mesenteric artery. In this study, we developed a novel method to control the pancreatic blood flow in laparoscopic enucleation--blocking the abdominal trunk and superior mesenteric artery with vascular occlusion clips in the process of resection, and evaluated its effectiveness and safety.

Between March 2023 and May 2026, patients who underwent laparoscopic pancreatic enucleation by blocking both the abdominal trunk and superior mesenteric artery in the Second Affiliated Hospital of Zhejiang University would be included in our prospective study. Inclusion criteria: 1) benign or borderline tumors diagnosed pathologically, such as pancreatic neuroendocrine tumors, solid pseudopapillary tumors, and cystadenomas, without vascular invasion or distant metastasis;.2) tumors sited in the pancreatic head, neck, and uncinate process of pancreas; 3) blockade of both the abdominal trunk and superior mesenteric artery in the laparoscopic enucleation. Exclusion criteria:1) highly malignant pancreatic tumors, or tumors with infiltration or metastasis; 2) tumors of the body and tail of the pancreas;3) transfer to LPD or laparotomy. Patient characteristic including clinical, biochemical and radiological data will be recorded and analyzed. All patients will provide written informed consent before inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Benign or borderline tumors diagnosed pathologically, such as pancreatic neuroendocrine tumors, solid pseudopapillary tumors, and cystadenomas, without vascular invasion or distant metastasis
* Tumors sited in the pancreatic head, neck, and uncinate process of pancreas
* Blockade of both the abdominal trunk and superior mesenteric artery in the laparoscopic enucleation

Exclusion Criteria:

* Highly malignant pancreatic tumors, or tumors with infiltration or metastasis
* Tumors of the body and tail of the pancreas
* Transfer to LPD or laparotomy
Prognostic Value of SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma

Prognostic interest of bone scintigraphy in bone metastatic prostate carcinoma (BMPC) has been shown. Recent technological advances allow to perform quantitative bone SPECT-CT in routine practice. The aim of this study is to assess the prognostic interest of quantitative bone SPECT-CT in BMPC.

Prostate adenocarcinoma is one of the most common cancer in men, and bone its most frequent distant metastasis location. 5-year survival has greatly increased these last two decades, with wide differences between countries. Nevertheless, the prognosis of castrate-resistant bone metastatic prostate cancer (BMPC) remains poor.

PCWG (Prostate Cancer Working Group) 2 has proposed in 2007 criteria to evaluate response to treatment for prostate cancer. There are based on composite data, including clinical signs (such as general condition and bone pain), Prostatic Specific Antigen (PSA) variation, CT scan (RECIST criteria) and bone scan. The scintigraphic part is based on whole body planar acquisition, and on the assessment of new uptakes. These bone scan criteria are simplistic, because only a visual analysis is possible, without consideration of changes in intensity. Moreover, these criteria consider the bone scan as a planar imaging, and it has been shown that Single Photon Emission Computed Tomography (SPECT) improved sensitivity, specificity, positive and negative predictive values in oncologic context. Finally, "PCWG2 (Prostate Cancer Working Group 2) recognizes that there are no validated criteria for response on radionuclide bone scan".

To reflect bone metastasis burden, a quantitative analysis method for bone scintigraphy, the Bone Scan Index (BSI), had been tested. BSI is based on the uptake of whole body planar imaging. While baseline BSI seemed to offer a poor correlation with overall survival (OS), on-treatment changes in BSI appeared to be a decent response marker. But a volumetric quantitative biomarker may improve the accuracy of this assessment.

The recent development of a new SPECT quantification tool (xSPECT Quant® tool, Siemens) could offer good performances on therapeutic assessment. The objective of this study is to assess the interest of this new quantitative volumetric method in bone scan response evaluation of BMPC.

Eligibility Criteria:
Inclusion Criteria:

Patients who underwent a bone SPECT-CT (Symbia INTEVO T6) between april 2014 and april 2017, with bone metastatic prostate cancer.

No opposition of the patient to participate in the study.

Exclusion Criteria:

Opposition of the patient. Age\<18 y/o
Metformin for Weight Control in Adolescents Taking Atypical Antipsychotics

Atypical antipsychotics (AA) are broadly used to treat a variety of psychiatric and neurological disorders in children and adolescents. Weight gain is a common side effect of these drugs. AA induced weight gain can be the cause of the metabolic syndrome which is a major health concern, as well as cancer and significant psychological disorders. Weight gain may also lead to low compliance with AAs.

A number of studies have been conducted in order to find a way to prevent, reduce or reverse AA induced weight gain in children and adolescents, but so far there is no commonly accepted treatment for the problem.

Metformin is an antihyperglycemic drug, approved by the FDA for treatment of type 2 diabetes in children older than 10 years of age. The drug usually does not cause hypoglycemia, even in high dosage. Contraindications include renal impairment, hepatic disease, a past history of lactic acidosis (of any cause), cardiac failure requiring pharmacological therapy, or chronic hypoxic lung disease. The drug also should be discontinued temporarily prior to the administration of intravenous contrast media and prior to any surgical procedure. The reported incidence of lactic acidosis during metformin treatment is less than 0.1 cases per 1000 patient-years, and the mortality risk is even lower.

Acute side effects of metformin, which occur in up to 20% of patients, include diarrhea, abdominal discomfort, nausea, metallic taste, and anorexia. These usually can be minimized by increasing the dosage of the drug slowly, when indicated, and taking it with meals. Intestinal absorption of vitamin B 12 and folate often is decreased during chronic metformin therapy, and calcium supplements reverse the effect of metformin on vitamin B12 absorption.

Three studies have studied the effect of metformin on weight gain secondary to use of AAs in adults and 3 other studies studied the effect of metformin in children and adolescents. Most of these studies have proved the drug to be efficient. No serious side effects have been demonstrated in any of these studies.

Objective- To assess the effect of metformin on body weight of children and adolescents treated by AAs.

Setting- recruitment and follow up would take place in the pediatric ward and outpatient clinic at the Ness- Tziona Mental Health Center.

Participants- 30 adolescents aged 12- 20 years old, treated with AAs, who are overweight as defined by more than 10% of what is expected according to age and height.

Importance of the Study

1. Identify a medication capable of reducing or preventing weight gain by an AA agent.
2. Identify an agent capable of improving compliance due to lower side-effect profile of AAs.


Eligibility Criteria:
Inclusion Criteria:

* 12-20 year olds treated by atypical antipsychotics
* weight gain of more than 10% than expected for age
* Overweight of more than 10% than expected for age and height

Exclusion Criteria:

* Physical conditions requiring pharmacological treatment
* Changes in drug type or dosage 2 months before the trial, except for 25% changes in dosage
Pulmonary Function and Neuromuscular Disease

This study aims to describe the evolution of pulmonary function in 3 neuromuscular diseases : Duchenne muscular dystrophy, Werdnig-Hoffinann disease, congenital myopathy, monitored in Besançon university hospital.


Eligibility Criteria:
Inclusion Criteria:

* Neuromuscular disease
* Followed-up in Besançon University Hospital
* With at least 2 Pulmonary Function Tests previously performed

Exclusion Criteria:

* Mental deficiency
* Facial expressions disorders