cyrilzakka/clinical-trials huggingface dataset:
Study of a Structured Parent Intervention on Adolescent Weight Loss Modification Program.

The study will enroll 110 overweight and obese adolescents ages 11-16 in a lifestyle modification program focusing on dietary modification and exercise. Parents will be randomized into control and motivational interviewing-based intervention groups. The primary hypothesis is that adolescents whose parents are in the intervention group will have improved compliance, weight loss and health outcomes compared with adolescents whose parents do not receive the intervention.

Adolescents will participate in a 6-month intensive lifestyle modification that includes a structured exercise program, nutrition education and dietary modification and behavioral support, followed by a 6-month maintenance phase with monthly booster sessions. Parents will be randomized to participate in 4 dedicated "pre-treatment" parent psychoeducational sessions vs. control (no psychoeducational sessions). The sessions will explore parents' feelings about participation in a weight management program, explore their reasons for wanting to make behavioral changes, and enhance motivation. All parents will participate in monthly parent support groups while their adolescents are participating in the intervention phase of the study. The 6-month adolescent intervention will include biweekly sessions with a registered dietitian for dietary education; biweekly interactive group discussion sessions on topics pertaining to motivation, strategies for changing health behaviors, setting and keeping goals and dealing with peer pressure; and exercise sessions three times a week with 30 minutes of cardiovascular exercise and 30 minutes of strength training each session. Comprehensive assessments, including nutrition, behavior and exercise assessments, laboratory work, body composition measurements and medical assessments will be conducted at baseline, 6 months and 12 months.

Eligibility Criteria:
Inclusion Criteria: Age 11 - 16; BMI \> 85th percentile; one parent or guardian committed to participate in protocol; -

Exclusion Criteria: Previous enrollment in IRB3354, IRB3008 or HM11113; Underlying genetic, neurological, endocrine or metabolic condition that preclude weight loss with conventional diet and exercise programs; Weight greater than 400 pounds, Pregnancy in female subjects; Inability to understand study instructions due to language barrier or mental disability; Primary residence outside a 30 mile radius of study location.

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The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery

Surgical stress induces stress hormone release and sympathetic hyperactivation. Dexmedetomidine has sympatholytic effect and attenuates stress responses. This study investigate the effect of dexmedetomidine on stress responses and autonomic nervous system balance in patients undergoing major spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
* patient scheduled for major spine surgery

Exclusion Criteria:

* ASA physical status Ⅳ
* congestive heart failure
* severe hepatorenal disease
* insulin dependent DM(diabetes mellitus)
* cancer or metastasis
* pregnancy
* problem with communication
Incidence and Neonatal Outcome of Eclamptic Parturient in Tertiary Hospital.

Eclampsia is a rare but serious disease that can happen during the pregnancy. Both general and regional anesthesia can both be performed in eclamptic patients. Eclamptic patients has greater risk if undergo general anesthesia such as risks associated with general anesthesia in pregnancy and also cerebral hemorrhage risks from hypertension during laryngoscope application and thrombocytopenia that can happen in eclamptic patients. So, most of Anesthesiologists tend to avoid performing general anesthesia in these patients. But spinal anesthesia also has side effects such as hypotension or epidural hematoma. And nowadays there's minimal evidence on suitable anesthesia in eclamptic patients. Our study wants to review on how choice of anesthesia affects these patients both mothers and their neonates


Eligibility Criteria:
Inclusion Criteria:

* Patient who diagnosed with eclampsia.

Exclusion Criteria:

* Incomplete medical record.
Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection

Phase I test of concept study: In an attempt to induce new immunity to HIV-1 during untreated HIV-1 infection the investigators have identified relatively immune silent immune subdominant HLA-A2-restricted HIV-1 CTL epitopes that fit individuals with the HLA-A2 tissue type (about 50% of peoples in Denmark). Immunising with these conserved epitopes could induce new immunity and lower viral load so the patient will live longer before AIDS or Antiviral medicine and a lower viral load will limit spread in the population. As adjuvants the investigators used patients' own autologous Dendritic Cells generated from blood cells in vitro. 12 healthy male HIV-1 infected not in therapy individuals were used for this therapeutic vaccination and tested for safety and induction of new cellular CD8 and CD4 T-cell immunity.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive male
* Viral load \>1000/ml
* CD4 count \>300
* HLA-A2 tissue type
* 18-50 years of age
* Able to follow the instructions
* Informed consent

Exclusion Criteria:

* Treated with other experimental vaccines or immune modulatig medicine
* Other chronic infectious diseases
* Allergy or autoimmune disease
Clinical Research of 18F-Alfatide Ⅱ PET/CT in Breast Cancer

18F-Alfatide Ⅱ PET/CT in breast cancer patients

The investigators aim to assess the clinical application of 18F-Alfatide Ⅱ PET/CT in the diagnosis and treatment response monitoring of breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* The patients have been suspected or diagnosed with breast cancer and they have not received any treatment; It must fulfill the ethical requirements and subjects have signed an informed consent.

Exclusion Criteria:

* Pregnancy or nursing mothers; Those patients accompanied by other serious diseases such as cardiac functional insufficiency, hepatic and renal function insufficiency.
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study

The purpose of the 12-week core study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide.

The purpose of the first 12-week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2356.

The purpose of the second 48 week open-label extension study was to collect additional long-term safety and tolerability data in patients who have completed the first extension study CACZ885H2356E1.

Masking:

Core: Double Blind (Subject, Investigator) Extension 1: Double Blind (Subject, Investigator) Extension 2: Open-label, terminated

Eligibility Criteria:
Core Study:

Inclusion criteria:

* Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout
* Onset of current acute gout flare within 5 days prior to study entry
* Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
* History of ≥ 3 gout flares within the 12 months prior to study entry
* Contraindication, intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine

Exclusion criteria:

* Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
* Presence of severe renal function impairment
* Use of specified pain relief medications or biologics ( corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor) within specified periods prior to study entry
* Live vaccinations within 3 months prior to randomization
* Requirement for administration of antibiotics against latent tuberculosis (TB)
* Refractory heart failure (Stage D)
* Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
* Any active or recurrent bacterial, fungal, or viral infection

Extension Study 1:

Inclusion Completion of the Core study. A patient was defined as completing the core study if they completed the study up to and including visit 7.

Exclusion

- Continuation in this extension study was considered inappropriate by the treating physician.

Extension Study 2:

Inclusion Completed of the first extension study CACZ885H2356E1. A patient was defined as completing the first extension study if they completed the study up to and including Visit 10).

Exclusion

-Continuation in this extension study was considered inappropriate by the treating physician

Other protocol-defined inclusion-exclusion criteria applied to the core and extension studies.
Effects of Laser Therapy and Exercise in Participants With Chronic Low Back Pain

The objective of this clinical trial is to evaluate the additional effects of Laser Therapy in participants with chronic non-specific low back pain in the short and long term.

The objective of this clinical trial is to evaluate the additional effects of Photobiomodulation Therapy in participants with chronic non-specifc low back pain in the short and long term.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-specific chronic LBP, defined as pain or discomfort between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs;
* Persistent LBP for at least 3 months;
* Low back pain of intensity reported 3 or higher by the Visual Analogue Scale (VAS), at least once in the previous 7 days;
* Aged between 18 and 65 years;
* Both genders.

Exclusion Criteria:

* Patients with severe skin diseases (eg, skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
* Participants with known or suspected serious spinal pathology (e.g., fractures, tumors, inflammatory, rheumatologic disorders, or infective diseases of the spine);
* Nerve root compromise;
* History of previous spinal surgery (even in a segment other than the lumbar spine) or scheduled surgery;
* Pain due to or associated with pregnancy or structural deformity (for example, scoliosis);
* Pregnancy;
* Comorbid health conditions that could prevent active participation in the exercise programs such as high blood pressure, pregnancy, or cardio-respiratory illnesses;
* Having answered "yes" to any of the questions in the Physical Activity Readiness Questionnaire (PAR-Q);
* Be treated with PBMT;
* Being under physiotherapeutic treatment or perform physical exercise;
* Who are using NSAID or start it during the trial;
* Who have inability to tolerate the proposed experimental procedures (such as tests of mobility and strength of the lumbar muscles).
Respiratory Functions Response To Tens Acupoint Stimulation Post Inhalation Injury

this study designed to examine the effect of Acu-TENS applied bilaterally on Ding Chuan acupoint to boost pulmonary functions, improve diaphragmatic excursion and decrease dyspnea in patients with inhalation injuries.


Eligibility Criteria:
Inclusion Criteria:

* Partial or full-thickness major burns
* Diagnosis of smoke inhalation based on the history of smoke exposure and chest computed tomography (CT)
* Have no systemic disease
* Body mass index less than 30.

Exclusion Criteria:

* Patients with any other pulmonary condition
* Cardiac condition
* Rib fracture
* Systemic disease
* Local infection and cigarette or tobacco use
Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer

This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.

Patients will be stratified by site of disease (visceral vs. non-visceral) and by onset of metastatic disease diagnose (patients metastatic de novo versus non de novo).

Eligibility Criteria:
Inclusion Criteria:

1. Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
2. Confirmed diagnosis of HR+/HER2- breast cancer
3. Post-menopausal status
4. No prior chemotherapy line in the metastatic setting
5. Measurable disease defined by RECIST version 1.1, or non-measurable disease
6. Eastern Cooperative Oncology Group (ECOG) PS 0-1
7. Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
8. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCICTCAE version 4.0 Grade equal or minor than 1

Exclusion Criteria:

1. ER or HER2 unknown disease
2. HER2 positive disease based on local laboratory results
3. Locally advanced breast cancer candidate for a radical treatment
4. Prior (neo)adjuvant endocrine treatment with DFI ≤ 12-months from completion of treatment.
5. Patients with rapidly progressive visceral disease or visceral crisis.
6. Major surgery within 4 weeks of start of study drug
7. Patients with an active, bleeding diathesis
8. Serious concomitant systemic disorder incompatible with the study
9. Are unable to swallow tablets
10. Chronic daily treatment with corticosteroids with a dose of ≥ 10mg/day methylprednisolone equivalent
11. Known active uncontrolled or symptomatic CNS metastases
12. Known hypersensitivity to letrozole, fulvestrant or any of their excipients, or to any PD-0332991 excipients
13. QTc \> 480 msec on basal assessments, personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes
14. Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug
Laquinimod Phase IIa Study in Active Crohn's Disease

The study aims to evaluate the safety and clinical effect of daily oral treatment of Laquinimod capsules in active moderate to severe Crohn's disease. This study will assess Laquinimod doses of 0.5mg /day to 2 mg/day in sequential dose groups (cohorts). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects diagnosed with Crohn's disease for at least 3 months prior to screening.
2. Moderate to severe Crohn's disease patients as determined by the CDAI score

Exclusion Criteria:

1. Subjects who have had recent bowel surgery
2. Subjects with clinically significant GI obstructive symptoms
3. Subjects with a clinically significant or unstable medical or surgical condition
4. Subjects with unstable doses of standard of care medications (5-ASA, antibiotics, oral corticosteroids, immunosuppressants )
5. Women who are pregnant or nursing or who intend to be during the study period.
6. Women of child-bearing potential who do not practice an acceptable method of birth control
Lead Migration During the Spinal Cord Stimulation Trial Period and Therapeutic Response

The goal of this clinical trial is to compare lead migration distance and therapeutic response for participants receiving a spinal cord stimulator during the trial period. Of note- scs trial period is a procedure name, not to be confused with this clinical trial study.

The main question\[s\] it aims to answer are:

* Is there a difference in migration distance and/or rate for those with external leads secured by an anchor device versus and anchor device with suture?
* How does participant activity levels during the trial period compare to migration rates? ° Does the temperature, heat index, and humidity during the trial period impact migration rates? Participants will come in for the scs trial procedure as normal. They will be asked to complete an activity survey upon return to the clinic for lead pull after the scs trial. They will also have an additional image upon return to the clinic to document lead position prior to lead pull.

Researchers will compare two groups- those with securement via anchor and those with securement via anchor and suture to see if there is an impact on therapeutic effect (percentage of pain relief) form the scs trial.


Eligibility Criteria:
Inclusion Criteria:

Adults ages 18 and over without a failed spinal stimulation trial or implant will be accepted into the study. Patients must have a diagnosis of chronic back pain and must be patients of the identified anesthesiologists and have their procedures performed at AUHS pain clinic.

Exclusion Criteria:

Patients will be excluded if they have a history of local anesthetic allergy (lidocaine), current skin infections at the procedure site, or a diagnosis of diaphoresis/ secondary hyperhidrosis (chronic over sweating).
Treatments for Brain Metastases With Poor Prognostic Factors

The goal of this observational study is to learn about treatments in brain metastases with poor prognostic factors. The main questions it aims to answer are:

* What kind of local treatment provides a survival benefit for patients with poor prognostic factors?
* What kind of systemic treatment provides a survival benefit for patients with poor prognostic factors?
* Will the combination of local treatment and systemic treatment provide a survival benefit for patients with poor prognostic factors?

Participants will be asked to provide personal information about their living status, symptoms, and disease control during the follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Evidence of pathological diagnosis of primary tumor;
2. Brain metastases confirmed by enhanced magnetic resonance imaging;
3. Complete clinical information

Exclusion Criteria:

1. Survival time less than 30 days;
2. If surgical treatment is accepted, the surgical treatment is not tumor resection, but ventricle puncture, biopsy and other non-tumor reducing surgery;
3. Incomplete clinical data;
4. Patients with 2 or more types of tumors.
Magnetic Resonance Elastography in Patients With Acute Closed Traumatic Brain Injury

Traumatic brain injury (TBI) is a major public health issue, and intracranial hypertension in the acute phase remains a critical scientific issue. Many patients with acute closed TBI received conservative, non-surgical treatments at first, while 5%\~19% of which develops intractable intracranial hypertension that requires emergent surgery. Therefore, it is of great clinical significance to identify patients who are at high risk of deterioration in the early stage. Previous studies have found that brain compliance is a contributive factor to intracranial pressure, and might serve in the development of intracranial hypertension after TBI. We made assumption that intracranial pressure has a negative relationship with brain compliance providing that the volume of hematoma remains constant. However, few studies have applied magnetic resonance elastography (MRE) in evaluating brain compliance in patients with TBI. Therefore, this study is designed to enroll patients with acute closed traumatic brain injury who are initially treated non-surgically. Magnetic resonance elastography (MRE) sequences are performed to non-invasively assess patients' brain compliances, in the hope of exploring the potential value of MRE biomarkers to predict the short-term outcome in patients with acute closed TBI who are initially receive non-surgical treatments.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years old
* Acute closed traumatic brain injury within 7 days
* Not receiving surgical intervention according to the judgement of neurosurgeons
* Expected tolerance of magnetic resonance imaging (MRI) scan 7 days from injury

Exclusion Criteria:

* Vital organ failure: congestive heart failure, respiratory failure, renal failure (CKD≥stage 3), severe hepatic dysfunction (Child-Pugh stage B or C)
* Any central nervous system (CNS) pathology prior to injury: stroke, epilepsy, CNS tumour/infections, dementia or other neurodegenerative diseases
* CT reveals infratentorial hematoma
* Contraindications of MRI
* Currently enrolled in other researches
Association Between the Level of EV-TF and the Occurence of Pulmonary Embolism in Patients With ARDS

In this study, 120 patients with Acute Respiratory Distress Syndrome (ARDS) will be included on a two years-period in an intensive care unit (Assistance Publique des Hôpitaux de Marseille, France). Those patients will benefit from a blood test at inclusion in order to measure several coagulation biomarkers, including EV-TF. Subsequently, these patients will be treated according to the usual practices of the department, following recommendations. Patients who received an injected CT scan between Day 5 and Day 28 will be divided into two groups based on the presence or absence of a pulmonary embolism on imaging. The measured values of EV-TF levels and other studied biomarkers will be compared between these two groups in order to detect a possible association between them and the diagnosis of pulmonary embolism. It should be noted that patients receiving an injected CT-scan between Day 5 and Day 7 will be included in the main analysis while those receiving it between Day 8 and Day 28 will be included in the secondary analysis. Others will be excluded from any analysis. At the same time, several collections of clinical data will be carried out: on Day 1, Day 7, Day 28, and on the day of the CT scan if it is performed at another time.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older,
* Patient who has given his/her non-opposition to participate in this study, or alternatively, patient for whom a relative has given his/her non-opposition to participate in this study,
* Patient admitted to intensive care for less than 24 hours,
* Patient with ARDS according to the Berlin criteria,

  * Hypoxemia with PaO2/FiO2 ratio ≤ 300 on mechanical ventilation under PEEP ≥ 5 cmH2O,
  * Bilateral alveolar-interstitial opacities on chest imaging (chest X-ray or CT),
  * Exclusion of a cardiogenic cause on echocardiography,
  * Acute or subacute onset within 7 days based on the clinical-radiological profile.

Exclusion Criteria:

* Positive SARS-CoV-2 PCR in a pharyngeal or respiratory sample (cytobacteriological examination of sputum, bronchial aspiration or bronchoalveolar lavage) prior to admission to the intensive care unit,
* Patient with a pathology affecting the coagulation process or endothelial function (hemophilia, von Willebrand disease, etc.),
* Patient receiving curative anticoagulant treatment before admission to the intensive care unit,
* Patient undergoing extracorporeal veno-venous respiratory assistance (ECMO-VV) before admission to the intensive care unit,
* Patient undergoing extra-renal purification with systemic anticoagulation with heparin before admission to the intensive care unit,
* Persons referred to in articles L. 1121-5 to L. 1121-8 of the Public Health Code (minor patients, adult patients under tutorship or guardianship, patients deprived of their liberty, pregnant or nursing women),
* Moribund patients for whom the life expectancy is less than 24 hours according to the opinion of the investigating physician.