cyrilzakka/clinical-trials huggingface dataset:
Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau Fractures

The investigators use existing resources to carry out this new technology, in accord with the standard of the patients, were randomized to traditional fracture balloon tibia fixation or arthroscopic reduction under angioplasty, the original data and data acquisition in a certain period of time corresponding to the patient, through statistical and epidemiological analysis and comparison of the method of professional data analysis discussion and experience according to the analysis results, the balloon angioplasty tibial arthroscopy and traditional open reduction and internal fixation for the clinical differences between postoperative recovery of tibial plateau articular surface reduction and joint function, and feedback the results to guide the clinical diagnosis and treatment.

The Balloon Tibioplasty arthroscopic assisted forming technique based on the existing data, the subject of the design, 1. patients met the inclusion criteria, were randomized to traditional fracture tibial fixation or balloon assisted arthroscopic reduction under angioplasty, through follow-up, statistical evaluation after operation were compared between the two techniques for clinical curative effect the difference of tibial plateau articular surface reduction and recovery of joint function. 2., through the clinical practice, operation and experience summary, found that the new technology in the operation of the existing deficiencies, in order to improve the technology. 3 guide clinical diagnosis and treatment through results feedback and analysis.The investigators use existing resources to carry out this new technology, in accord with the standard of the patients, were randomized to traditional fracture balloon tibia fixation or arthroscopic reduction under angioplasty, the original data and data acquisition in a certain period of time corresponding to the patient, through statistical and epidemiological analysis and comparison of the method of professional data analysis discussion and experience according to the analysis results, the balloon angioplasty tibial arthroscopy and traditional open reduction and internal fixation for the clinical differences between postoperative recovery of tibial plateau articular surface reduction and joint function, and feedback the results to guide the clinical diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* fresh closed fracture X-ray and CT examination confirmed Schatzker II-IV type tibial plateau fracture patients.
* the patient signed the informed consent.

Exclusion Criteria:

* Pathologic fractures, patients with neurologic disorders, and skeletally immature patients.
Mollii Suit and Fibromyalgia (EXOFIB 2)

The goal of this clinical trial is to demonstrate the improvement of fibromyalgia syndrome obtained following active stimulation compared to sham, with diminished functional disability and improved health status using Exopulse Molli suit stimulation. The main questions it aims to answer are:

Evaluation of pain, fatigue, mood and quality of life changes observed after active stimulation in comparison to sham.

Improvement of fibromyalgia syndrome as per the Fibromyalgia Impact Questionnaire (FIQ)

Study subjects will participate in:

A randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75 years, with a definite diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010 criteria, set for at least one month.
* Patients should be able to understand verbal instructions.

Exclusion Criteria:

* Patient with VAS \< 4
* Patient included in another research protocol during the study period
* Patient unable to undergo medical monitor for the study purposes due to geographical or social reasons
* Patient with contraindication to wearing Exopulse Mollii suit (e.g., cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump, pregnancy, and/or body mass index above 35 kg/m2)
* Patient with other somatic or psychiatric diagnoses other than anxiety and depression (e.g., arrhythmias, uncontrolled epilepsy, other diseases causing osteoarticular and muscular pain)
* Any change in the pharmacological therapy in the last three months
* Introduction of a medical device other than Exopulse Mollii suit during the study period
* Patient under juridical protection
Endothelial Biomarkers of Systemic Sclerosis-associated Pulmonary Hypertension

Systemic sclerosis (SSc, AKA scleroderma) is an autoimmune condition characterized by endothelial damage and progressive fibrosis of the skin and internal organs. One of the leading causes of morbidity and mortality in patients with SSc is pulmonary hypertension (PH), which is estimated to occur in up to 31% of high risk SSc patients. Early detection of patients with SSc-PH may lead to improved outcomes and although there have been concerted efforts to accurately screen for SSc-PH, these patients continue to present with advanced disease and suffer from poor survival. Therefore, better methods to screen for patients with PH and, perhaps more importantly, to screen for those at risk for PH development are desperately needed. Since PH and SSc are disorders originating from the endothelium, biomarkers that reflect endothelial damage are very promising tools to identify early disease. Such potential biomarkers include endothelial microparticles, asymmetric dimethylarginine (ADMA), pentraxin-3, and soluble endoglin. No previous study has used a combination of these biomarkers to detect the presence of PH in patients with SSc, or studied the novel concept of exercise-induced changes in biomarker levels. The investigators will collect the above listed endothelial biomarkers before and after exercise, and combine these levels with exercise echocardiogram findings, and routine clinical information to derive a composite detection score for the early identification of systemic sclerosis-associated PH.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age \>18 years 2. Meet American College of Rheumatology criteria for SSc

Exclusion Criteria:

1. Chronic kidney disease (estimated creatinine clearance \<50mL/min)
2. Uncontrolled hypertension (diastolic blood pressure\>120mmHg)
3. Acute coronary syndrome within the past 6 months
4. Chronic obstructive pulmonary disease
5. Diabetes mellitus
6. Hemolytic anemia
7. Active tobacco abuse
Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment

Introduction: Prolonged use of antiretroviral therapy is associated with metabolic and bodily changes such as lipodystrophy, diabetes mellitus, insulin resistance and dyslipidemia latter being associated with a higher chance of cardiovascular events and death.

Objective: To evaluate the effect of nutritional therapy in dyslipidemic adolescents living with HIV / AIDS in antiretroviral therapy.

Method: This is a randomized clinical trial with young people 13-19 years in outpatient treatment in a general hospital to present dyslipidemia. The intervention group received nutritional counseling for 12 weeks and weekly flights to nutritional counseling. The control group received standard care consisting of medical care. Demographic, clinical, nutritional variables, food surveys and lipid profiles were collected at baseline and at the end of the study for both groups.

This is a open randomized clinical trial. The participants were adolescents (13 to 19 years old) diagnosed with HIV / AIDS from the Pediatric Infectious Disease Outpatient Clinic - zone 4, from a tertiary care university hospital in the South Region in Brazil, along with their caregivers. Present Dyslipidemia, characterized by Total Cholesterol\> 200mg / dL associated with:Triglycerides ≥ 150mg HDL cholesterol (male \<40 mg / dL and female \<50 mg / dL) LDL cholesterol ≥ 160 mg / dL. The clinical profile, immunological, virological, the biochemical parameters will be accessed by the patient's chart and the dietary parameters will be evaluated by means of 24-hour reminder instrument. The sample was calculated, using a software, from an alpha error of 5%, reliability power of 80%, to obtain detection difference and standard deviation for each of the group of 40, totaling 36 patients.

The randomization will be performed through simple randomization in blocks of 2 patients generated by computer program, available at www.randomization.com.

The intervention group received nutritional counseling for 12 weeks and weekly flights to nutritional counseling. The control group received standard care consisting of medical care. Demographic, clinical, nutritional variables, food surveys and lipid profiles were collected at baseline and at the end of the study for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed HIV infection with a positive result obtained by performing a screening test for anti-HIV-1 and anti-HIV-2 and at least one confirmatory test;
* Being on antiretroviral therapy for at least three months prior to the start of the study;
* Present current biochemical exams: Dyslipidemia, characterized by Total Cholesterol\> 170mg / dL associated with: Triglycerides greater than or equal to LDL cholesterol ≥ 130 mg / dL;
* Availability to participate in the nutritional intervention with a low fat diet.

Exclusion Criteria:

* Pregnant women;
* Patients with active opportunistic infections;
* Cognitive deficits;
* Diabetes mellitus;
* Patients taking lipid-lowering drugs;
* Patients who are unaware of their HIV diagnosis.
Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration During Lower Extremity Tibial Interventions

Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration during Lower Extremity Tibial Interventions

This is a prospective, multi-center, non-randomized, open label, single arm post-market clinical study to gather data on the use of the Protexus catheter for temporary blood vessel occlusion while standard of care treatment with other therapeutic devices is conducted in patients undergoing infrapopliteal treatment for peripheral arterial disease (PAD).

Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years of age
2. Subject or authorized representative has signed a written Informed Consent
3. Subject is willing to comply with the protocol requirements
4. Rutherford classification 4-6
5. Planned intervention of the native infrapopliteal arteries using balloon angioplasty, atherectomy, and endovascular procedures.
6. Reference vessel diameter for intended location of the distal tip funnel deployment for the Protexus catheter is ≥3.5mm and ≤6.0mm by visual estimate
7. Inflow arteries have ≤30% stenosis. Inflow arteries can be treated at the time of the study procedure to achieve ≤30% stenosis

Exclusion Criteria:

1. Prior intervention within 30 days of treatment in the planned deployment site for the Protexus catheter
2. Presence of a stent in the planned deployment site for the Protexus catheter
3. Has perforation, dissection, or other injury of the access vessel or Protexus catheter deployment site requiring additional stenting or surgical intervention before enrollment
4. History of bleeding diathesis or coagulopathy and unable to receive standard anticoagulation during the index procedure
5. Acute limb ischemia defined as onset of symptoms within two weeks of the planned intervention
6. Inflow arteries have \>30% stenosis after treatment at the time of the study procedure
7. Pregnant female subject or subject that has a positive pregnancy test within the previous 7 days
8. Known hypersensitivity or allergy to nitinol
9. Target blood vessels are infected, have extreme tortuosity, or are occluded with calcified material
Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa

The primary objective of this study is to evaluate the safety and tolerability of a single dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)

CF patients often have lung infections. Pseudomonas aeruginosa (Pa) is the most significant bacteria in CF, with up to 80% of CF patients eventually becoming infected. These patients are often treated with antibiotics with variable results. This study will examine the impact of a single-dose of an investigational drug, KB001, on Pa bacteria in the CF lung.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Confirmed diagnosis of CF based on the following criteria:

Positive sweat chloride greater than 60mEq/liter, and/or a genotype with 2 identifiable mutations consistent with CF, and one or more clinical features consistent with the CF phenotype

* Age \>/= 18 years of age with the potential for age 12 \>/=
* Screening Pa sputum culture
* FEV1% predicted \>/= 40 (based on Wang's equations for Males aged 12-17 and females 12-15 years, and Hankinson's equations for all other patients)

Exclusion Criteria:

* Evidence of an acute respiratory infection or pulmonary exacerbation within 4 weeks prior to day 0
* Use of systemic corticosteroids or antibiotics within 4 weeks prior to day 0, or cyclic inhaled antibiotics within 14 days prior to day 0.
* History of positive B. cepacia complex, organ transplantation, hepatic disease or venal dysfunction
* Current cigarette smoker, history of drug addiction or alcohol abuse
* Use of investigational medication or participation in an investigational study within 4 weeks prior to day 0
* Women who are pregnant or breastfeeding and patients and/or partner unwilling to use an effective form of barrier contraception throughout the study
Audit on Anemia Variation After Major Gynacological Surgery

The study aims to increase our understanding of variability in adherence to anaemia management guidelines and to assess the impact of anaemia management in clinical care following major gynaecological surgery

Anemia affects nearly a quarter of the world and is common in surgical patients with a third of patients presenting with preoperative anemia and three quarters of patients discharged from hospital with anemia. The World Health Organization defines anemia as an insufficient circulating red cell mass, with haemoglobin (Hb) concentration of \< 130 g.l-1 for men and \< 120 g.l-1 for women .

Perioperative anemia is associated with increased postoperative complications and delayed patient recovery leading to increased post-operative morbidity and mortality. Anaemia also leads to an increased use of allogeneic blood transfusions, which is an independent risk for poorer patient outcomes.

Postoperative anemia can be due to blood loss at operation or secondary to the inflammatory process associated with surgery, which causes an increase in hepcidin production resulting in functional iron deficiency and reduced red cell production.

In recent years, there has been a significant increase in the use of intravenous iron therapy for preoperative anemia in line with major international guidelines

Eligibility Criteria:
Inclusion Criteria:

* Age: Adult, 18_60 years
* Procedure: A major gynecological surgery is defined as an operation with an incision into the abdominal cavity and anticipated duration of more than one hour. Procedures performed using any surgical approach, including open and laparoscopic surgery are included.
* Urgency: Patients undergoing planned (elective or expedited) or unplanned (emergency) surgery

Exclusion Criteria:

* Procedures: surgery classified as minor operations such as; diagnostic laparoscopy (emergency or elective), D\&C.
* Indication: Palliative procedures as determined pre-operatively and explicitly stated in the medical record or consent form.
* Return to theatre: Each patient should only be included in the study once. Patients returning to theatre due to complications following earlier surgery
Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood

The SALTO-SNA study is an ancillary study of the SALTO study (Suivi À Long Terme en Oncologie des enfants guéris d'un cancer pédiatrique en régions Rhône-Alpes et Auvergne) coordinated by Dr. Claire Berger, pediatric oncologist at the CHU, Saint Etienne. It aims at re-examining, in their initial treatment center, all patients (a cohort of 495 patients alive in 2011), diagnosed between 1987 and 1992, and cured of childhood cancer (except leukemia) in the Rhône-Alpes and Auvergne regions.

The rationale for this study is based on the observation that although the survival rate of childhood cancers has now reached 75%, complications of chemotherapy and radiotherapy are high and greatly increase the risk of mortality in later years (estimated to be 14% in the literature).

The morbidity risk of chemotherapy and radiotherapy can be quantified by assessing the activity of the intrinsic cardiac autonomic regulation, which represents a powerful predictor of cardiovascular morbidity to the individual.

For this purpose, analysis of the cardiac RR variability is a reliable, non-invasive and reproducible system that could be used in this population as a tool for early detection of cardiovascular dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Included in the SALTO study
* Having signed the informed consent form

Exclusion Criteria:

* General anesthesia in the two weeks prior to recording
* Known allergy to electrodes
Nutrition Counseling to Lower Serum Phosphorus Levels

Hemodialysis patients who receive frequent weekly nutrition counseling using motivational interviewing techniques will have lower serum phosphorus levels compared to patients receiving standard treatment.

Hemodialysis patients will receive weekly nutrition counseling on how to lower their serum Phosphorus levels. Motivational interviewing techniques and strategies will be employed such as reflective listening, using affirmations, and summarizing. Average serum Phosphorus levels pre-dialysis will be compared to s.Ph post counseling. This will be compared to a group receiving nutrition counseling via standard treatment on a monthly basis.

Eligibility Criteria:
Inclusion Criteria:

* ESRD patients on dialysis with serum Ph \> 5.5 mg/dL four of six labs over 6 months, mentally competent

Exclusion Criteria:

* ESRD patients on dialysis with serum Ph \< 5.5 mg/dL four of six labs over 6 months, mentally incompetent
A Study of PET Scans With the Radioactive Tracer 18F-BMS-986229 in Patients With Esophageal, Stomach, or Gastroesophageal Junction Cancer

The purpose of the study is to test 18F-BMS-986229 positron emission tomography (PET) imaging a practical and safe way to check the status of esophageal, stomach, and gastroesophageal junction cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have pathologically or cytolofically confirmed (at MSK) esophageal, gastric, or gastroesophageal junction adenocarcinoma or squamous cell carcinoma
* PD-L1-positive expression in \>/=1% of the tumor or stromal cells. PD-L1 expression will be reviewed by MSK pathologist, scored and recorded using the combined positive score (CPS) formula (number of PD-L1 positive tumor cells, lymphocytes, and macrophages divided by the number of tumor cells x 100).
* Participants must have disease that can be evaluated radiographically. This may be measurable disease or nonmeasurable disease according to RECIST 1.1.
* Concurrent therapy is allowed.
* Age 18 years or older.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours before receiving the first dose of the study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Adequate organ function, as defined in Table 1. All screening labs should be performed within 14 days of initiation of treatment.

Hematological Absolute neutrophil count: \>/=1,000/mCL Platelets: \>/=90,000/mCL Hemoglobin: \>/=8 g/dL

Renal Serum creatinine: \</=2.0 x upper limit of normal (ULN)

Hepatic Serum total bilirubin: \</=2.5 x ULN (1.5 mg/dL or 25.65 umol/L) OR (except patients with Gilbert's disease \[\</=3 x ULN\]) AST (SGOT) and ALT (SGPT): \</=2.5 x ULN OR \</=5 x ULN for subjects with liver metastases

Exclusion Criteria:

* Known diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment
* History of active tuberculosis (Bacillus tuberculosis)
* Active or documented autoimmune or inflammatory disorder (including inflammatory bowel disease, systemic lupus erythematous, Wegener syndrome \[granulomatosis with polyangitis\], myasthenia gravis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis) within the 3 years before the start of treatment. The following are exceptions to this criterion:

  * Subjects with vitiligo or alopecia
  * Subjects with hypothyroidism (e.g., following Hashimoto syndrome) who are stable with hormone replacement therapy or with psoriasis not requiring systemic treatment