cyrilzakka/clinical-trials huggingface dataset:
Glucose Insulin Potassium With Intensive Insulin Therapy and (GIK2) Versus GIK Alone

The aim of this study is to evaluate the effect of the glucose insulin potassium (GIK) infusion associated with intensive insulin therapy compared to GIK alone and control group in patients presenting to the ED with acute coronary syndrome.

It is well recognised that diabetes is a factor of worse prognosis in acute coronary syndrome (ACS). Recently, the relationship between the glucidic metabolism and cardiac ischemia was highlighted whether patients have diabetes or not. Indeed, it was established that hyperglycemia occurring during hospitalization in non diabetic patients, is a powerful risk factor of death.

Stress related hyperglycemia occurs during number of acute pathological situations (AMI, stroke, pancreatitis, hypothermia, hypoxia, cirrhosis, polytrauma, burn, sepsis.... It is due to an excess of hyperglycemia hormones (glucagon, growth hormone, catecholamines and glucosteroids) and of inflammatory mediators (cytokines...). Hyperglycemia has several deleterious effects on the cardiovascular system as it promotes microvascular inflammatory reaction, activation of the coagulation system, and free radical oxygen liberation.

Currently, the idea of controlling glycemia in surgical and medical intensive care patients is widely accepted and maintaining blood sugar level closest to normal by intensive insulin therapy became largely recommended.

Several decades ago, glucose-insulin-potassium infusion (GIK) was proposed to protect acute cardiac ischemia. GIK has been assessed in many previous studies.

The results of these studies are contradictory. According to CREATE-ECLA study which is the largest (including 20201 patients), GIK didn't show a significant beneficial effect in ACS. However, in these trials using GIK alone glycemia was not strictly controlled.

Recently, the importance of tight glycemic control has been highlighted in ICU patients and early post heart surgery. Our hypothesis is that GIK treatment associated to intensive insulin therapy in ACS would be beneficial and superior to GIK alone possibly because intensive insulin therapy would prevent potential deleterious effects of hyperglycemia induced by GIK.

Eligibility Criteria:
Inclusion Criteria:

* All patients fulfilling ACS criteria with or without known diabetes.

Exclusion Criteria:

* Patients under 18 years old.
* Killip II class or SaO2 ≤ 90%.
* Blood creatinine ≥ 180 µmol/L
* Potassium serum ≥ 6.5 mmol/L.
The Effect of Inspiratory Muscle Training on Postural Stability, Posture Perception and Trunk Rotation in Children With Adolescent Idiopathic Scoliosis.

Trunk rotation and distortion of the rib cage, which are common in patients with adolescent idiopathic scoliosis, result in abnormal configuration of the diaphragm and intercostal muscles. This reduces the capacity of the respiratory muscles to produce force, and results in respiratory muscle weakness. The diaphragm, which is the major respiratory muscle, is also a component of the core muscles responsible for postural stability. Therefore, diaphragm muscle weakness results in deterioration of postural stability. Our aim in this study is to investigate the effect of inspiratory muscle training added to the routine scoliosis exercise program on postural stability and posture perception.


Eligibility Criteria:
Inclusion Criteria:

* Having adolescent idiopathic scoliosis with a Cobb angle of 20-50° diagnosed by an orthopedic surgeon

Exclusion Criteria:

* Having a documented diagnosis of neurological disorders
* Having a documented diagnosis of mental disorders which may affect cooperation
* Having a documented diagnosis of chronic airway diseases
* Having a documented diagnosis of orthopedic disorders which may affect mobility
R4Power: An Online Resilience Program for Adolescents

The study will evaluate the R4Power program, an online intervention designed to teach adolescents coping and problem-solving skills.

This study examines the feasibility of a 10-lesson web-based intervention, the R4Power program, and its effectiveness in preventing symptoms of depression and anxiety. The R4Power Program teaches cognitive and problem-solving skills covered in classroom based interventions, including the Penn Resiliency Program, that have been found to reduce or prevent symptoms of depression in children and adolescents. This study examines whether adolescents can benefit from learning these skills through a computer (rather than classroom) intervention.

Adolescents in grades 6 through 8 who participate in this study will be assigned to one of two conditions: an intervention group that will complete the R4Power program during the first year (R4Power1), or a waitlist control group that will complete the R4Power program the following year (R4Power2). Students will complete the 10-lesson program over the course of twelve weeks. They will learn and practice cognitive skills (recognizing the link between their thoughts and feelings, identifying thinking traps, challenging their negative beliefs) and problem-solving skills (assertiveness, relaxation and distraction, overcoming procrastination, and decision making). Adolescents who participate in this study will be followed for one year, and their coping responses and symptoms of depression and anxiety will be assessed at four points: at the beginning of the study (baseline) and at follow-up assessments approximately 4, 12 and 16 months after baseline.

Eligibility Criteria:
Inclusion Criteria:

* 6th-8th grade students attending participating school OR adolescents aged 11-15 living in greater Philadelphia area
* Access to high speed internet connection (at home, school, or another location)

Exclusion Criteria:

* Below 6th grade reading level, as reported by parents
Allo-hNHL (FluBuCy)

DSHNHL R3 is a randomized clinical phase II study. The main objective is to estimate the efficacy of rituximab as a prophylactic medication for prevention of graft-versus-host-disease after allogeneic peripheral stem cell transplantation in patients with a high risk relapse of aggressive B-cell Non-Hodgkin's lymphoma. The most important secondary objective is to estimate the efficacy of allogeneic stem cell transplantation in this clinical situation.

Patients in the age of 18 to 65 years with a high- risk relapse of a histology proven aggressive Non-Hodgkin's-lymphoma are eligible for the trial. Aggressive Non-Hodgkin's lymphoma within this study is defined as:

B-NHL:

follicular lymphoma grade III° lymphoblastic (precursor) lymphoma diffuse large cell cell lymphoma any subtype and variant including primary mediastinal lymphoma mantle cell lymphoma, blastic variant

T-NHL:

precursor T cell lymphoma peripheral T cell lymphoma, any subtype and variant angioimmunoblastic lymphoma anaplastic large cell lymphoma, any subtype NK / T cell lymphoma High risk relapsed or progressive disease is defined as (a) primary progressive disease, (b) early relapse after less than 12 month of remission duration and at least one risk factor according to the international prognostic index (IPI), (c) relapse or progression after high dose chemotherapy and autologous transplantation, (d) relapse or progression and lack of an autologous stem cell product.

Patients with this type of progression / relapse should receive rituximab plus ifosfamide/carboplatin/etoposide (R-ICE) or rituximab plus dexamethasone/high dose ARA-C/cisplatinum as salvage therapy (recommendation, not part of study medication). In patients biwth T cell lymphoma rituximab may be replaced by alemtuzumab. If at least stable disease is achieved, patients can be definitely included.

With inclusion, patients were randomized to receive either 375 mg/ m2 of rituximab at weeks 3, 4, 5, 6, 25, 26, 27, 28 after allogeneic stem cell transplantation or no additional medication.

Conditioning for transplantation consisted of Fludarabine 125 mg/m2, Busulfan 12 mg/kg and cyclophosphamide 120 mg/kg.

Short-term (day 1 to day 28) mycophenolat mofetil and tacrolimus are used as basis GVHD prophylaxis in all patients. Anti-thymocyte globulin can be used due to the centres decision in patients with unrelated donors

Eligibility Criteria:
Inclusion Criteria:

* histology proven aggressive non Hodgkin's lymphoma and
* primary progressive disease or
* early relapse after less than 12 month of remission duration and at least one risk factor according to the international prognostic index (IPI or
* relapse or progression after high dose chemotherapy and autologous transplantation or
* relapse or progression and lack of an autologous stem cell product.

Exclusion Criteria:

* severe comorbidity or impaired organ function
* hypersensitivity to used drugs
* HIV positivity
* active hepatitis
* other active malignant disease
Analysis of the Virtual Acute Care at Home Experience

The purpose of this study is to examine the implementation, intervention effectiveness, and dissemination of a digital acute care delivery model for improving selected health outcomes in the Hospital at Home population.

The investigators will conduct a mixed-methods quasi-experimental research study that will explore the effectiveness of the Hospital at home programs using qualitative interviews and quantitative data as a means to also conduct a process evaluation related to the implementation and efficacy of Hospital at Home programs. The purpose of this pragmatic study is to inform scalability beyond the initial site for implementation within a large healthcare system with a diverse patient population located in various communities, including rural and urban locations.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older who are admitted into the Hospital at Home program after presenting to the emergency department or who are inpatients that can be cared at home for hospital level needs
* Patients meeting the hospital's criteria for admission by diagnosis type (e.g., heart failure, respiratory infections and inflammations, renal failure, diabetes, pneumonia, bronchitis, chronic obstructive pulmonary disease, fever and inflammatory conditions, viral illnesses, other disorders of the nervous system). Diagnoses are determined by clinicians not researchers.
* Patients will need to reside within 30 minutes' drive time from the hospital

Patient caregiver inclusion criteria: (not required for patient participation):

* Age \>= 18 years old
* as capacity to consent to study

Clinician or stakeholder inclusion criteria:

* Any member of the home hospital clinical team (a healthcare professional who providing care or equipment for use in the home) who will be participating in delivery of healthcare services,
* Any member of the hospital care teams, including the screening and recruitment of patients for the home hospital intervention and/or providing care to patients that enroll in the intervention that is provided
* Any member of the leadership team who are involved in the operational aspects of program delivery

Exclusion Criteria:

* Need for long-term facility level care or current residence in a facility of this type
* No one will be excluded on the basis of sex or race
Effects of Liothyronine on Energy Expenditure and Cardiovascular Function

This study will assess the short term effects of a single dose of liothyronine on the cardiovascular system and energy expenditure


Eligibility Criteria:
Inclusion Criteria:

* BMI \>20\<30 kg/m2
* TSH \>0.5\<5.0 mcIU/mL
* Negative TPO antibodies

Exclusion Criteria:

* Pregnancy
* Use of prescription drugs
* Diabetes mellitus
* Coronary artery disease
* Hypertension
* Anemia
* Renal insufficiency
* Liver disease or ALT \>2.5 x the upper laboratory reference limit
Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee

The objective of this trial is to demonstrate superior efficacy and safety of MACI compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with symptomatic articular cartilage defects of the knee.

This is a prospective, randomized, open-label, parallel-group, multicenter study designed to investigate the outcome of MACI implant versus arthroscopic microfracture in the treatment of articular cartilage defects in the knee in patients between ages of 18 and 55 years.

All patients who meet the eligibility criteria and are considered suitable for inclusion will have a cartilage biopsy taken prior to randomization to study treatment. Eligible patients will then be randomized during the index arthroscopy procedure to receive either MACI implant or microfracture treatment.

Patients randomized to treatment with MACI implant will return within approximately 4 to 8 weeks of the index arthroscopy to undergo the chondrocyte implantation procedure via arthrotomy. Patients randomized to microfracture will undergo the procedure during the index arthroscopy.

Patients will be assessed post-arthroscopy and post-arthrotomy at intervals during 2 years follow-up. Evaluations include adverse events, functional and pain outcomes, arthroscopic and histologic evaluation and magnetic resonance imaging (MRI).

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement

Exclusion Criteria:

* Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
* Severe osteoarthritis of the knee
* Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders
* Prior knee surgery (within 6 months), excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant.
Brain Computer Interfaces (Mu Rhythm Learning)

Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for controlling electronic devices using only brain signals.

The Mu rhythm is a naturally occuring wave produced by the brain. This research project will determine how to best train subjects to use the Mu rhythm for computer control.

As a method of BCI control, Mu rhythms are difficult to learn and involve extensive training. The investigators want to keep users motivated and determine the best way to provide effective training. Healthy users will be trained to control a computer by wearing an electrode cap that is connected to a computer. They will have their levels of motivation and interest measured while learning to use the Mu rhythm. Two different types of learning programs will be used to determine which is most effective for Mu rhythm training. This method will be used for device control by people with severe physical impairments, who may be able to communicate or carry out other desired tasks using a BCI.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Able to read text on a computer screen
* Able to understand and remember instructions concerning participation

Exclusion Criteria:

* Unable give informed consent.
* Unable to understand and follow instructions.
* Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings.
* Known to have photosensitive epilepsy.
* Open head lesions or sores
Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome

Axillary web syndrome(AWS) is common complication of breast cancer surgery. Overall, AWS affects more than a half of the patient receiving axillary lymph node dissection. The symptoms of AWS include pain, limited function and range of motion. Geater risk of secondary lymphedema was found if the patient developed AWS during the first postoperative year.

ESWT was used for treating myofascial pain for decades. Low energy ESWT combined with complex decongestive therapy had a benefit on shoulder joint ROM and skin thickness improvement in patients with BCRL in recently studies. Investigators wonder if ESWT can also be applied to patients with axillary web syndrome for increasing ROM and relieving pain.

The aim of this study was to evaluate the therapeutic effects of low energy ESWT in patients with axillary web syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Axillary web syndrome patient
2. Unilateral breast cancer and received related operation(mastectomy/ALND/SLND)
3. Completion of beast related chemotherapy or radiotherapy
4. Age with 20-65 years old

Exclusion Criteria:

1. Ongoing metastasis or recurrence of the breast cancer
2. Other cancer history
3. Lymphatic transplantation or reconstruction
4. Wound, infection or trauma over affected arm
5. Coagulopathy or poor circulation
6. Pregnancy
7. Oral anticoagulant using
Avenanthramides and Exercise

The aim of the proposed study is to examine whether long-term dietary supplementation (8 weeks) of an oat flour cookie rich in avenanthramides (AVA) could enhance blood antioxidant capacity and reduce blood inflammatory markers after a downhill running (DR) protocol among human subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female non-obese subjects (18kg/M2\<BMI\<28kg/M2) (age 20-45 years) will be recruited from the Twin Cities community. All participants will sign informed consent approved by UMN-IRB and are willing to avoid oat consumption and rigorous physical activity the day prior to and through test and to consume a low-polyphenol diet for 1 week prior to the study. The foods rich in polyphenols include all berries, apples, pears, citrus fruits, fruit juices, onions, chocolate, wine, coffee, tea, beans, nuts, soy products and most spices

Exclusion Criteria:

1. Presence of GI conditions that interfere with absorption;
2. Clinically significant endocrine, cardiovascular, pulmonary, renal, hepatic, pancreatic, biliary or neurologic disorders;
3. Major trauma or surgery within 3 months of visit;
4. Cancer in the prior 2 years;
5. Allergic to oat products;
6. Women who are pregnant or lactating;
7. Smoking;
8. Drinking alcohol \>5 drinks/week;
9. Using nutraceuticals;
10. Blood pressure medication;
11. NSAID (\>800 mg ibuprofen/week)
12. Vitamin supplementation
13. Anticoagulants or hypoglycemic drugs
14. Oat products consumption and rigorous physical activity the day before the test and consumption of a high-polyphenol diet in week prior to the test.
15. Moderate-intensity cardiorespiratory exercise training for ≥30 min•d-1 on ≥5 d•wk-1 for a total of ≥150 min•wk-1, vigorous-intensity cardiorespiratory exercise training for ≥20 min•d-1 on ≥3 d•wk-1 (≥75 min•wk-1), or a combination of moderate- and vigorous-intensity exercise to achieve a total energy expenditure of ≥500-1000 MET•min•wk-1
Cardiovascular Events Based On Statin Initiation In The Elderly

The purpose of this study is to compare rates and risk of primary cardiovascular events among elderly patients newly initiating therapy with atorvastatin or simvastatin. The specific objectives for this project are to: 1) examine the demographic and clinical characteristics of the elderly patients in whom atorvastatin or simvastatin was newly initiated; and 2) compare cardiovascular event rates in elderly patients in whom atorvastatin or simvastatin was newly initiated.

All subjects meeting sample definition, all inclusion criteria, and none of the exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 1 fill for atorvastatin or simvastatin (not including combination therapy) between 01 July 2006 and 30 November 2008
* Age ≥ 65 years as of the year of index date
* Continuous enrollment with medical and pharmacy benefits during the analytic period

Exclusion Criteria:

* 1 or more fills for a statin or other dyslipidemia medication in the 12-month pre-index period
* A pharmacy fill for clopidogrel or nitrates (except concomitant hydralazine) in the 12-month pre-index period
* Patients with evidence of a cardiovascular event in the 12-month pre-index period.
* Patients who received both atorvastatin and simvastatin on the index date
* Patients with unknown gender or region
* Patients who received dyslipidemia medications other than the index drug within 1 months (30 days) following the index date
Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).

Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and the other the reference drug hMG (Menopur, Ferring Pharmaceuticals, Inc.).

The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous hMG preparations (hMG-IBSA, IBSA vs Menopur, Ferring Pharmaceuticals, Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing ovarian stimulation for IVF with or without ICSI (intracytoplasmic sperm injection) and with the following characteristics:
* Voluntary given informed consent to study participation in writing encompassing consent to data recording and verification procedures;
* \> 18/= and \< 37 years old;
* BMI between 18 and 28 kg/m2;
* Less than 3 previous completed IVF cycles;
* Basal FSH level less than 10 IU/L once within 6 months prior to the study;
* Within 12 month of the beginning of the study, uterine cavity consistent with expected normal function as assessed through a hysterosalpingogram, or sonohysterogram, or hysteroscopic examination or TVUS;
* Normal or clinically insignificant haematology and blood chemistry values.

Exclusion Criteria:

* Primary ovarian failure or women known as poor responders;
* Signs of PCO, according to the Rotterdam Criteria;
* At least one ovary inaccessible for oocyte retrieval;
* One or more ovarian cysts \> 10 mm;
* Hydrosalpinx that have not been surgically removed or ligated;
* Stage III or IV endometriosis;
* Patients affected by pathologies associated with any contraindication of being pregnant;
* Hypersensitivity to the study medication;
* Abnormal bleeding of undetermined origin;
* Uncontrolled thyroid or adrenal dysfunction;
* Neoplasias;
* PAP smear III within the last 2 years;
* Severe impairment of the renal and/or hepatic functions;
* Lactation;
* Hyperprolactinaemia;
* Participation in a concurrent clinical trial or in another trial within the past four weeks;
* Use of concomitant medication that might interfere with study evaluations.
Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension

This study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 years of age or older
* msDBP and msSBP requirements:

  * 3A:

    * Diagnosis of moderate to severe hypertension (msSBP ≥ 160 mmHg and \< 200 mmHg, and/or msDBP ≥ 100 mmHg and \< 120 mmHg) at Visits 4, 5 or 6 (Qualifying BP visit)
    * In addition, at the visit immediately prior to the above qualifying visit, patients were also to have msSBP ≥ 145 mmHg and \< 200 mmHg and msDBP ≥ 95 mmHg and \< 120 mmHg) at Visits 3, 5 or 5.
    * Patients had to meet the above two sets of requirements at subsequent adjacent visits, i.e. either Visits 3 and 4, Visits 4 and 5, or Visits 5 and 6.
  * OR
  * 3B:

    * msSBP ≥ 180 mmHg and \< 200 mmHg with msDBP ≥ 95 mmHg and \< 120 mmHg, or msDBP ≥ 110 mmHg and \< 120 mmHg with msSBP ≥ 150 mmHg and \< 200 mmHg after at least one week of treatment with placebo (Visit 3 and on).

Exclusion Criteria:

* Continued use of anti-hypertensive medicines or use of 4 or more hypertensive medicines at study start
* Patients with an msSBP ≥ 200 mmHg or msDBP ≥ 120 mmHg at any time during the placebo run-in period were to be discontinued from the study.
* Extremely elevated (defined) blood pressure at any point during the study
* Pregnant or lactating women
* Pre-menopausal women not taking accepted form of birth control
* History or evidence of secondary form of hypertension
* History of cardiovascular conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.