bioihbjkbjnl/mcl2 huggingface dataset:
Impact of the Addition of Metformin to Abiraterone in Metastatic Prostate Cancer Patients
Condition: Metastatic Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the impact of the addition of metformin to abiraterone
      on survival in patients with metastatic prostate cancer
    

Detailed description: 
      The purpose of this study is to assess the impact of the addition of metformin to abiraterone
      on survival in patients with metastatic chemotherapy-naive prostate cancer
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Adding Metformin to Abiraterone in case of PSA-Progression
Other intervention name(s): Abiraterone
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of NeuroAD on the Cognitive Function of Alzheimer Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The study tests the effect of the NeuroAD on Alzheimer patients' cognitive function. The
      NeuroAD uses non-invasive stimulation of both magnetic and cognitive training.
    

Detailed description: 
      The NeuroAD system is a combined system of Transcranial Magnetic Stimulation and cognitive
      training and is a non-invasive therapeutic system for the improvement of Alzheimer patients'
      cognitive function.

      A potential participant will undergo screening procedures to confirm eligibility to
      participate in the study, followed by randomization procedure to one of the study groups -
      treatment or sham (placebo) Patient will attend the clinic 5 times a week for 6 weeks,
      approximately an hour every day for treatment/sham. The patient will be required to return to
      the clinic for follow-up.

      Up to 150 patients will be enrolled in up to 10 clinical sites in the US and Israel.
    

Intervention name(s): TMS and cognitive stimulation; sham
Intervention type(s): Device; Device
Intervention description(s): Synchronized TMS and cognitive stimulation to 6 brain areas.
Other intervention name(s): NeuroAD; NICE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Alzheimer's; TMS; Cognitive Training; NeuroAD
Neuromuscular Training and Strengthening CORE in Volleyball Amateur Players 18 to 25 Years
Condition: Stability
Study type: Interventional

Summary: 
      Introduction. The most popular injuries in volleyball are the ones who occur in knee joints,
      due the jumps and landings that happen through the game. For this reason there is a high
      index of loss of stability because of the dynamic valgus during the landing, a loss of
      balance and a decrease of power during the jumps.

      Objective. Evaluate the effectiveness of neuromuscular training in combination with
      strengthening of CORE in the improvement of knee joint stability, balance and power in
      vertical jump in volleyball players from 18 to 25 years old.

      Study design. Randomized, multicenter, single-blind clinical study with follow-up period.

      Methods. The study will be realized with an initial sample of 30 players, which in a random
      way, will be divided into two groups: experimental and control. It will be realized an
      initial evaluation where sociodemographic, anthropometric and clinical measures will be
      taken, and the study variables: knee joint stability (single leg squat test), balance (star
      excursion balance test) and vertical jump (sargent jump test). The intervention will last six
      weeks, with two sessions per week of approximately twenty minutes each.

      Expected results. The investigators expected to observe improvement in the stability in the
      knee joint, balance and power in the vertical jump in 18-25 years volleyball players that
      have received a neuromuscular training with strengthening of CORE.
    


Intervention name(s): Experimental; Control
Intervention type(s): Other; Other
Intervention description(s): The player will perform exercises of balance, stability, and strengthening of the abdomen, back and gluteus. All these exercises will be carried out in first instance on flat surfaces and later on unstable surfaces to increase the difficulty of it. The training will be done in different levels of difficulty, once the participant managed to master the initial level, advance to the next level to complete the three levels of difficulty during the 6 weeks of training. There will be 3 repetitions of each exercise with a duration of one minute and breaks of 30 seconds between each repetition and 2 minutes of rest between exercises. The duration of the intervention of the experimental group will last 20 minutes; Neuromuscular training will be applied through balance and stability exercises on both flat and unstable surfaces. There will be 3 repetitions of each exercise with a duration of one minute and breaks of 30 seconds between each repetition and 2 minutes of rest between exercises. The duration of each session of the control group is 10 minutes.
Other intervention name(s): Neuromuscular training and strengthening of CORE; Neuromuscular training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Study of a New LY900014 Formulation in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is
      administered by injection under the skin of the abdomen. The study will be conducted in
      healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of
      different doses of LY900014 on blood sugar levels. Side effects and tolerability will be
      documented. The study will last for about 8 to 9 weeks for each participant, including
      screening and follow up. Screening is required within 28 days prior to entering the study.
    


Intervention name(s): LY900014; Insulin Lispro (Humalog)
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): Ultra-Rapid Lispro; LY275585; Humalog
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Condition: Cytomegalovirus Retinitis; HIV Infections
MeSH terms: Infections; Cytomegalovirus Retinitis; Retinitis
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS
      patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the
      safety and efficacy of foscarnet maintenance therapy for treatment of AIDS patients
      experiencing CMV retinitis.
    


Intervention name(s): Foscarnet sodium
Intervention type(s): Drug
Intervention MeSH terms: Foscarnet; Phosphonoacetic Acid
Primary purpose: Treatment
Keywords: Retinitis; AIDS-Related Opportunistic Infections; Foscarnet; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome
Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)
Condition: Alopecia
MeSH terms: Alopecia
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical alopecia occurs due to miniaturization of the hair shafts as well as loss of active
      production of hair shafts. PRFM has been shown to induce dermal angiogenesis, and anecdotal
      findings of improvement of hair appearance after PRFM injection in the scalp suggest that
      PRFM may play a role in the treatment of thinning hair. Patients will be treated on a monthly
      basis with intradermal injections of autologous PRFM for 3 months. Changes in hair density
      will be assessed by comparing pre- and post-treatment photographs and non-invasive
      measurements of hair density at 1, 2, 3, 4 and 6 months after initial treatment.
    


Intervention name(s): PRFM treatment
Intervention type(s): Biological
Intervention description(s): Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alopecia
The Effects of High-intensity Interval Training on Mental Health and Inflammation
Condition: Anxiety; Depressive Symptoms; Inflammation
MeSH terms: Inflammation; Depression
Study type: Interventional

Summary: 
      The present study investigated the effects of high-intensity interval exercise training and
      placebo-exercise on mental health and inflammation using a randomized control trial. The
      study also examined how anxiety symptoms prior to high-intensity interval training may
      influence improvements in fitness. Inactive young adults underwent nine weeks of either
      high-intensity interval training or their regular routine. Questionnaires, a blood draw and a
      maximal exercise test were conducted the week before and week after the intervention. It was
      hypothesized those who underwent high-intensity interval training would experience greater
      reductions in their depression, anxiety, and inflammation than those who were in the placebo
      control group. It was also hypothesized those who had high anxiety symptoms at the start of
      high-intensity interval training would experience smaller improvements in fitness than those
      who had low anxiety symptoms.
    


Intervention name(s): Exercise; Placebo
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Melatonin and Cardiac Outcome After Major Surgery
Condition: Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to assess whether treatment with melatonin can reduce cell
      damage and inflammatory stress response and thereby occurrence of myocardial injury after
      abdominal aortic surgery.
    

Detailed description: 
      Abdominal aortic surgery is associated with a significant increase of oxidative and
      inflammatory stress response. Aortic surgery is also associated with elevated troponin which
      is a sensitive and specific marker for myocardial injury. The severity of oxidative stress is
      correlated with elevated troponin. Melatonin, which is a hormone produced in brain, seems to
      modify cell damage and inflammation. On the other hand we know, that melatonin production
      first night after surgery is disturbed. The purpose of this study is therefore to determine
      whether treatment with melatonin can reduce cell damage and inflammation, and thereby
      occurrence of myocardial injury associated with abdominal aortic surgery.
    

Intervention name(s): Melatonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Melatonin 50 mg during surgery and 10 mg every night for 3 nights; a mixture of ethanol and physiological saline
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardiac morbidity; Melatonin; Surgery; Postoperative
Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass
Condition: Obesity, Morbid
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      to compare the results of SASI to SAS-J in treatment of morbid obesity
    

Detailed description: 
      200 of patients indicated for obesity surgery will be divided into 2 groups : Group 1, will
      be operated by SASI and Group 2, will be operated by SAS-J
    

Intervention name(s): SASI; SAS-J
Intervention type(s): Procedure; Procedure
Intervention description(s): Single-Anastomosis Sleeve ileal (SASI) Bypass; Single-Anastomosis Sleeve Jejunal (SAS-J) Bypass
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Metabolic Syndrome Observation on a Regional Basis
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      The aim of the study is to assess the prevalence of Metabolic Syndrome in Italy on a regional
      basis, defined according to NCEP/ATPIII Guidelines criteria.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Keywords: metabolic syndrome; lipids; waist circumference; HDL; hypertension
Optimal Balloon Catheter Placement During Sonohysterography
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Saline infusion sonohysterography and other intrauterine investigations methods may cause
      uterine cramping, pain and vasovagal reactions. According to few of previous studies the
      position of catheter placement can affect the magnitude of pain and amount of saline required
      during the sonohysterography. The purpose of this double blind control trial study is to
      assess whether the location of the balloon catheter either the uterus or cervix during
      sonohysterography can affect the magnitude of pain and the rate of vasovagal reaction.
    

Detailed description: 
      The proposal of study approved by the investigators institutional review boards and
      institution's ethical committee, and all participants will sign a written consent before
      enter to study. A total of 300 infertile women undergoing sonohysterography will be
      randomized to intrauterine or intracervical balloon catheter placement. The examination is
      scheduled in the early follicular phase of menstrual cycle, immediately after cessation of
      menstrual flow and before day 10. After preparation of patient, a 2 lumen 6-French flexible
      catheter is introduced into the cervical canal and balloon at the catheter tip is placed in
      the lower uterine segment or 1 cm into cervical canal and inflated with 1 mL of sterile
      saline solution. Under sonographic guidance, sterile normal saline solution (10-50 mL) is
      slowly introduced into the cavity until an adequate distention of the uterine cavity is
      obtained. Three-dimensional ultrasound scanned volumes are recorded. Patients are asked to
      assess their level of pain at the time of the balloon inflation and deflation using a
      10-point visual analog pain scale. Patients are checked for the sign and symptoms of
      vasovagal reaction during and 30 minutes after procedure. Outcome measures will be assessed
      based on the intent-to-treat principle.
    

Intervention name(s): sonohysterography with inflated catheter in uterine cavity; sonohysterography with inflated catheter in cervical cavity
Intervention type(s): Device; Device
Intervention description(s): during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity; During the procedure of sonohysterography balloon catheter is inflated in the cervical canal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sonohysterography; catheter placement; pain magnitude; vasovagal reaction
Comparative Evaluation of Various Combinable Magnetic Resonance (CMR) Pulse-sequences for Macrophage Imaging Using Ferucarbotran
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to:

        -  clarify whether macrophage imaging using ferucarbotran is able to delineate the region
           of myocardial infarction as accurate as gadolinium-based necrosis/fibrosis imaging;

        -  identify possible differences in infarct imaging using ferucarbotran for macrophage
           imaging compared to necrosis/fibrosis imaging with gadolinium-based compounds; and

        -  evaluate which MRI pulse-sequences maximise sensitivity for macrophage imaging with
           ferucarbotran in the setting of acute myocardial infarction.
    


Intervention name(s): Ferucarbotran (Resovist)
Intervention type(s): Drug
Intervention description(s): single time intravenous bolus injection of a contrast agent
Other intervention name(s): Resovist
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Ceftriaxone and Jaundice in Neonates
Condition: Jaundice and Sepsis in Neonates
MeSH terms: Jaundice
Study type: Observational

Summary: 
      Ceftriaxone is an antibiotic often used for the management of sepsis. Neonates commonly have
      jaundice during the first postnatal week. Ceftriaxone will be given as standard of care for
      sepsis and investigators will observe the effect on jaundice.
    


Intervention name(s): ceftriaxone
Intervention type(s): Drug
Intervention description(s): Eligible infants will receive ceftriaxone as standard of care for sepsis
Intervention MeSH terms: Ceftriaxone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Term neonates
A Study to Determine if Technosphere® Inhalation Powder (FDKP) Causes ECG Changes (QTc) Following the Medication's Inhaled Administration.
Condition: Healthy Subjects
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      48 healthy adult male & female subjects will be enrolled in this study to determine the
      effect of Technosphere® Inhalation Powder (FDKP) on the QT interval of the EKG. Eligible
      subjects will be randomized into a dosing regimen after admission.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, cross-over, placebo- and active-controlled
      cardiac safety study in 48 healthy subjects (both male and female subjects) designed to
      assess the effect of FDKP on cardiac repolarization, if any, following introduction of
      Technosphere® Inhalation Powder via inhalation. Each trial subject will be administered 20 mg
      of FDKP, 40 mg of FDKP, 400 mg oral dose of moxifloxacin (active), and placebo in a crossover
      design during an 11 day in-patient stay.
    

Intervention name(s): Technosphere Inhalation Powder (FDKP); Moxifloxacin; Technosphere Inhalation Powder (FDKP); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Technosphere® Inhalation Powder 20mg; Tablets 400mg; Technosphere® Inhalation Powder 40mg; Placebo cartridges
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy males and females
Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effects of continuous local anesthetic delivery
      on the immediate post-op recovery of patients undergoing spinal fusion surgery for congenital
      or idiopathic scoliosis.
    

Detailed description: 
      Constant local analgesic infusion is a relatively new modality that provides a constant
      supply of medication without the need for repeat injections. This method has shown
      encouraging results with respect to pain levels, narcotic use, faster rehabilitation and
      shorter hospital stay in patients undergoing laparotomies, iliac crest bone graft harvest,
      and sternotomies. In addition, there have not been any reported complications when used in
      these scenarios.

      We hope to confirm better pain control, less narcotic use (i.e. PCA), fewer narcotic side
      effects, better response to physical therapy and earlier discharge. Which may be generalized
      to the spinal surgery patient population as less pain and suffering and a better overall
      hospital course
    

Intervention name(s): Bupivacaine; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours; Normal Saline, 4ml/hour for 72 hours.
Other intervention name(s): Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Congenital Scoliosis; Idiopathic Scoliosis; Spinal Fusion; Post-Operative Pain Management; Infusion Catheter
Association Between Inflammatory Biomarkers and LV Function in Patients With CVD
Condition: Stable Angina; Heart Failure
MeSH terms: Heart Failure; Angina, Stable
Study type: Observational

Summary: 
      The association of novel inflammatory biomarkers with cardiovascular diseases is still
      obscure. The present study aimed to investigate the relationship of various inflammatory
      biomarkers with the existence as well as the extent of heart failure (HF) and coronary artery
      disease (CAD), suggesting a link between inflammation and cardiovascular diseases and
      all-cause 30- and -90 day of hospital readmission. Methods: We enrolled a total of 120
      patients with HF, asymptomatic CAD and 60 healthy controls (HC) without cardiovascular
      diseases.
    

Detailed description: 
      -  The present study aimed to investigate the relationship of various inflammatory
           biomarkers with the existence as well as the extent of heart failure (HF) and coronary
           artery disease (CAD), suggesting a link between inflammation and cardiovascular diseases
           and all-cause 30- and -90 day of hospital readmission.

        -  We enrolled a total of 60 patients with HF, 60 asymptomatic CAD patients and 60 healthy
           controls (HC) without cardiovascular diseases.

      Group I: 60 Healthy Subjects. Group II: 60 Patients with Stable Angina (asymptomatic CAD).
      Group III: 60 Patients with Heart Failure.

        -  Clinical parameters, glycemic and lipid profile, vaspin, visfatin, high-sensitivity
           C-reactive protein, sortilin, homocysteine, troponin I, fetuin A and lipoprotein A
           levels were assayed.

        -  Patients will be followed up to assess all-cause 30- and -90 day of hospital
           readmission.
    

Intervention name(s): Group I; Group II; Group III
Intervention type(s): Other; Other; Other
Intervention description(s): Healthy Subjects; Stable Angina Patients; Heart Failure Patients
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Group I: 60 Healthy Subjects. Group II: 60 Patients with Stable Angina (asyptomatic CAD).
        Group III: 60 Patients with Heart Failure.
      
Keywords: vaspin; visfatin; lipoprotein A; high-sensitivity C-reactive protein; sortilin; homocysteine; troponin I; fetuin A