bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study on the Use of Prophylactic Antibiotics for EUS-guided Pancreatic Cyst Aspiration
Condition: Pancreatic Cysts
MeSH terms: Cysts; Pancreatic Cyst
Study type: Interventional

Summary: 
      Our hypothesis is that a single dose of antibiotics at time of EUS-guided pancreatic cyst
      aspiration is equally effective to the usual regimen of 3 days of post-procedural
      antibiotics.
    

Detailed description: 
      With the increased use of cross sectional imaging, there appears to be an increasing
      prevalence of pancreatic cysts being incidentally discovered.

      A critical step in the workup of pancreas cysts is to determine whether the cyst is mucinous
      or non-mucinous, through a procedure called endoscopic ultrasound - fine needle aspiration
      (EUS-FNA).

      Current guidelines suggest the use of antibiotics in cyst aspiration, usually 3 days after
      the procedure. However, these recommendations are based on limited data from over 15 years
      ago. More recent retrospective observations suggest equivalent safety when little, or even no
      antibiotics are given.
    

Intervention name(s): Ciprofloxacin; Placebo (for ciprofloxacin)
Intervention type(s): Drug; Other
Intervention description(s): ciprofloxacin oral capsule (one capsule twice a day for 3 days); oral placebo capsule (one capsule twice a day for 3 days)
Other intervention name(s): Cipro; sugar pill formulated to mimic oral ciprofloxacin
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effect of a High Protein Diet Versus a Low Fat Diet on Body Weight After Smoking Cessation
Condition: Smoking; Overweight; Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether subjects following a high protein diet will
      gain less in weight after smoking cessation compared to subjects following a low fat diet due
      to the effects of protein on metabolic rate and hunger.
    

Detailed description: 
      Sustained smoking cessation is one of the most effective therapies to avoid premature
      morbidity and mortality. However, weight gain associated with nicotine withdrawal may
      attenuate some of the beneficial health effects and is cited as a major obstacle to quit
      smoking. The mechanism for the weight gain is not elucidated but reduced resting metabolic
      rate, reduced total energy expenditure, increased caloric intake and changes in fat
      metabolism may be involved. Elucidating effective strategies to prevent or reduce
      post-cessation weight gain may improve health outcomes of smoking cessation.
    

Intervention name(s): The high protein diet group and the low fat diet group
Intervention type(s): Other
Intervention description(s): The High Protein Diet Group was advised to have 25 energy percent from protein, 55 energy percent from fat, 20 energy percent from carbohydrate in the diet and the Low Fat Diet Group was advised to have 30 energy percent from fat, 20 energy percent from protein, 50 energy percent from carbohydrate in the diet.
Other intervention name(s): The high protein diet group; The low fat diet group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dietary intervention; Smoking cessation; Body weight
Study of the Safety & PK of INX-08189 in Chronically-infected HCV, Treatment-naïve Subjects
Condition: HCV (Genotype 1)
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the Safety and Pharmacokinetics of Multiple
      Ascending Oral Doses of INX-08189 in Chronically-infected Genotype 1 HCV, Treatment-naïve
      Subjects.
    

Detailed description: 
      This is a multi-center, sequential-cohort, double-blind, placebo-controlled, multiple
      ascending dose, 7-day treatment study in chronically-infected genotype 1 HCV, treatment-naïve
      subjects.

      Primary Objectives include:

      Safety

      • to evaluate the safety of ascending oral doses of INX-08189 given once a day for seven (7)
      days in chronically-infected genotype 1 HCV, treatment-naïve subjects

      Pharmacokinetic

      • to characterize the pharmacokinetic (PK) profile of multiple ascending oral doses of
      INX-08189 in chronically-infected genotype 1 HCV, treatment-naïve subjects

      Pharmacodynamic

      • to evaluate the relationship between the metrics of the reduction from baseline in serum
      HCV RNA and PK parameters of INX-08189 and the metabolite INX-08032

      Efficacy

      • to measure the maximal reduction in plasma HCV RNA by ascending oral dose level of
      INX-08189 given once a day for seven (7) days in chronically-infected genotype 1 HCV,
      treatment-naïve subjects
    

Intervention name(s): INX-08189; INX-08189; INX-08189; INX-08189; INX-08189; INX-08189; INX-08189; Placebo matching with INX-08189; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsules, Oral, 9 mg, Once Daily, 7 Days; Capsule, Oral, 25 mg, Once Daily, 7 days; Capsules, Oral, 50 mg, Single Dose, 1 day; Capsules, Oral, 9 mg, Once daily, 6 days; Capsules, Oral, 50 mg, Once daily, 7 days; Capsules, Oral, 9 mg, Once daily, 7 days; Capsules, Oral, 100 mg, Once daily, 7 days; Capsules, Oral, 0 mg, Once daily, 7 days; Capsules, Oral, 1000 or 1200 mg daily (delivered in weight-adjusted am/pm divided dose), 7 days
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Safety and Pharmacokinetics
Mandible and Sub-mandible Using the 1440nm Wavelength Laser and Hand Piece
Condition: Skin Tightening of the Mandibular and Sub-mandibular Areas
Study type: Interventional

Summary: 
      The purpose of this study is to use the 1440nm Wavelength laser along with the hand piece to
      provide clinical outcome data for treatment of the mandibular and submandibular areas
      specifically for skin tightening and laser lipolysis.
    


Intervention name(s): 1440 nm wavelength laser with handpiece (Cynosure)
Intervention type(s): Device
Intervention description(s): To assess the effectiveness of device in skin tightening and laser lipolysis in the mandibular and sub-mandibular areas.
Intervention model: Single Group Assignment
Intervention model description: Even though this study has recruited slightly more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Shoulder Functional Performance After Shoulder Surgery
Condition: Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Observational [Patient Registry]

Summary: 
      Rotator Cuff (RC) injuries are a progressive clinical condition that starts with an acute
      tendonitis, continues with partial thickness rupture and results in a full thickness rupture
      in the advanced period.

      Arthroscopic RC repair is effective in the acute RC ruptures treatment caused by traumatic
      events. In the acute period after arthroscopic RC repair, shoulder joint range of motion
      (ROM), muscle strength and shoulder functionality are decreased and daily activities are
      adversely affected. In the long-term, many studies have reported that these symptoms
      gradually decreaced.

      Many studies investigating postoperative treatment of RC rupture have mostly focused on
      parameters such as postoperative pain, functionality, muscle strength, ROM and quality of
      life.Evaluation of these clinical parameters is necessary for patient follow-up in the early
      period. However, it is unclear whether the biomechanical etiologic factors continue that lead
      to RC rupture in the advanced period after surgery.

      Therefore, the objective of this study was functional performance of shoulder after
      arthroscopic Rotator Cuff repair and ınvestigation of performance related factors.
    

Detailed description: 
      Design: observational Cross-sectional study.
    

Intervention name(s): Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)
Intervention type(s): Other
Intervention description(s): Participants were evaluated with all tests, respectively. To eliminate the fatigue factor, 5 minutes breaks were given after each test.
Other intervention name(s): Shoulder Functionality-Modified Constant Murley Score; Scapular Endurance-Scapular Muscle Endurance Test; Strength-Total Upper Extremity Muscle Strength
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study group consists of participants with undergone arthroscopic RC repair at Bolu
        Abant İzzet Baysal University, Department of Orthopedics and Traumatology.
High-protein and High-carbohydrate Diets' Effect on Urinary Concentrating Ability
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      We wanted to test urinary concentrating ability and AQP-2 expression in kidney during
      high-protein and high-carbohydrate diet.
    


Intervention name(s): High Protein diet; High carbohydrate diet
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Acetylsalicylic Acid Compared With the Combination of Acetylsalicylic Acid + Modified-release Dipyridamole on Serum Thromboxane B2 Formation and Platelet Aggregation in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole
      (200 mg) bd versus acetylsalicylic acid (75 mg dispersible tablet once daily) in its effect
      on inhibition of thromboxane B2 formation
    


Intervention name(s): Asasantin®; Acetylsalicylic acid low dose; Acetylsalicylic acid high dose
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): modified-release dipyridamole
Intervention MeSH terms: Aspirin; Dipyridamole; Aspirin, Dipyridamole Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral
      Testosterone Undecanoate (TU) in Hypogonadal Men
    

Detailed description: 
      This is a multicenter, Phase 3, randomized, open-label, active-comparator group, efficacy
      (based on Cavg of T), and safety study in adult hypogonadal male subjects. Enrollment is
      based on criteria designed to select the general population of hypogonadal men. Study drug
      doses will be titrated using a dose-titration algorithm based on total T Cavg. Subjects may
      be androgen treatment-naïve or washed out of prior androgen replacement therapies.

      Subjects must have 2 total T levels < 300 ng/dL based on 2 blood samples obtained in the
      morning (AM) on 2 separate days approximately 7 days apart.

      Approximately 180 subjects will be randomly assigned to receive open-label treatment in a 3:1
      ratio of oral TU to Axiron (ie, approximately 135 subjects will be randomly assigned to oral
      TU and approximately 45 subjects will be randomly assigned to Axiron topical solution).
      Subjects who complete the study will receive approximately 105 days of treatment. Dose
      titrations will be based on the T Cavg from serial PK sampling obtained on day 21 and 56 of
      treatment. Primary efficacy will be based on percentage of subjects within eugonadal range at
      Visit 7.

      A subset of approximately 30 subjects will participate in a cosyntropin stimulation test on
      Day 1 (before administration of study drug) and Day 106 after the last 24-hour PK sample has
      been drawn.
    

Intervention name(s): Oral Testosterone Undecanoate; Axiron Testosterone Topical Solution
Intervention type(s): Drug; Drug
Intervention description(s): Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.; Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.
Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
Other intervention name(s): Oral TU; Axiron solution
Intervention MeSH terms: Methyltestosterone; Pharmaceutical Solutions; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Use of an Ambulatory Capsule to Characterize Gastrointestinal Pressure Patterns in Children
Condition: Upper Gastrointestinal Motility Disorders
Study type: Observational

Summary: 
      This study will test a new medical device called the SmartPill GI Monitoring System, which is
      now used to diagnose gastric motility disorders in adults, in children. The study will
      compare the SmartPill capsule findings to antroduodenal manometry (ADM), which is a standard
      procedure currently used for the evaluation of gastric and duodenal motility in children. The
      ADM studies will be done for clinical purposes and only if recommended by the patient's
      gastroenterologist. The research portion of the study is limited to the use of SmartPill.
    

Detailed description: 
      ADM is a standard procedures used in children, but it has some limitations and disadvantages.
      Manometry studies involve placing catheters in the nose and are often poorly tolerated by
      children. Also, placement of the catheter requires sedation or anesthesia, the manometry test
      lasts several hours and involves ingestion of a meal which many children find difficult when
      having a catheter in their nose. The reason we are conducting this study is because we would
      like to find a new, less invasive, equally informative test for understanding
      gastrointestinal motility.

      The SmartPill GI Monitoring System uses a capsule, about the size of a large vitamin or
      PillCam capsule, which is swallowed and passed through the stool. While in the GI tract, the
      capsule measures the acidity (pH) and pressures, and these measurements are used to determine
      how long it takes for food to leave the stomach. Pressure and pH information are sent by the
      capsule to a receiver that the patient will either wear on the belt or keep within 2 feet.
      The receiver stores data collected about the pH, temperature, and pressure inside the GI
      tract. The SmartPill GI Monitoring System has already been approved by the Food and Drug
      Administration (FDA) for use in adults but not in children.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients coming to clinic for concerns of gastric or small bowel dysmotility
      
Keywords: antroduodenal manometry; gastric dysmotility; intestinal dysmotility
Dose Escalating Study of a Prototype CS6 Subunit Vaccine With a Modified Heat-labile Enterotoxin From Enterotoxigenic Escherichia Coli (ETEC)
Condition: Diarrhea
MeSH terms: Escherichia coli Infections; Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety of a prototype Coli surface antigen 6 (CS6) subunit
      vaccine (CssBA) alone or in combination with Escherichia coli double mutant heat labile toxin
      (dmLT) given by intramuscular (IM) injection.
    

Detailed description: 
      This is an open-label clinical trial in which a total of 50 participants will receive three
      injections of either CssBA alone, dmLT alone or CssBA + dmLT. The vaccine will be
      administered via IM injection to alternating deltoid regions on days 1, 22, and 43. Each
      participant will receive the same dose at each vaccination dependent upon group assignment.
      Group A is considered a pilot group in which all 3 doses will be administered and
      participants monitored for safety 7 days after the third vaccination, prior to the enrollment
      of participants in Group B.
    

Intervention name(s): CssBA; dmLT
Intervention type(s): Biological; Biological
Intervention description(s): Recombinant enterotoxigenic Escherichia coli (ETEC) surface antigen 6 containing modified structural subunits A and B; Escherichia coli double mutant heat-labile toxin with mutations at amino acids 192 and 211
Other intervention name(s): spd_dsc16Bntd14CssBAB7A[His]₆
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ETEC; Escherichia coli; enteric
The Effect of Healing Touch on Sleep
Condition: Elective Reconstructive Surgery Population
Study type: Interventional

Summary: 
      Healing Touch improves measures of sleep the night prior to surgery, thus improving
      surgery-related morbidity.
    

Detailed description: 
      Patients are to randomized into one of 4 treatment groups upon enrollment. Depending on
      randomization group, the study participant receives the treatment the evening before elective
      surgery. A polysomnographic sleep study is then completed. Plan is to review the effect of
      the treatment group on sleep quantity and sleep quality.
    

Intervention name(s): Healing Touch; Healing Touch, Sham; Control, Presence
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Functional Training on Motor Performance
Condition: Diplegia
Study type: Interventional

Summary: 
      The functional strength training is mainly dealt with anti-gravity muscles and aiming at
      maximal carry over in day to day activities. The functional strength training can be given
      using resistance and it may be gravity, body weight, resistance bands and free weights. The
      exercises are specific to the muscle or muscle groups recruited during the functional
      activities
    


Intervention name(s): functional training exercises
Intervention type(s): Other
Intervention description(s): progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week. The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intervention group received progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week. The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training.
Masking: Single (Participant)
Primary purpose: Treatment
Study of Duloxetine vs Placebo in Treatment of Binge Eating Disorder With Depression
Condition: Binge Eating; Depression
MeSH terms: Bulimia; Depression; Depressive Disorder; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to test the safety of duloxetine and see what effects
      (good and bad) it has on the subject's binge eating disorder and comorbid depressive disorder
      (depression occurring with binge eating disorder) compared to placebo (inactive pill).
    

Detailed description: 
      This is a 12-week, double blind, randomized, placebo-controlled, parallel-group,
      flexible-dose study of duloxetine 60-120 mg/day in patients with BED and comorbid depressive
      disorders. Patients will be randomly assigned to either duloxetine 30 mg capsules or matching
      placebo at the baseline visit. The initial dose of study medication will be one 30 mg
      duloxetine capsule/day or placebo with a planned increase to 60 mg/day (2 X 30 mg) or
      matching placebo at the end of week 1. Further dose increases of 30 mg up to 120 mg/day will
      be allowed after the end of week two based on the investigators' assessment of efficacy and
      tolerability. Dosing will be either once per day or twice a day depending on tolerability.
      Patient visits will occur at screening and baseline and at the end of weeks 1, 2, 4, 6, 8,
      10, and 12. Study drug will be tapered by 30 mg every 3 days at the end of the study.
    

Intervention name(s): Duloxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg/day - 120 mg/day; identical to study drug
Other intervention name(s): Cymbalta; Sugar pill
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Stroke Volume Variation and Pulse Pressure Variation as Predictors of Fluid Responsiveness During Kidney Transplantation
Condition: Kidney Transplantation
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim pf this prospective study is to investigate the ability of stroke volume variation
      (SVV) and pulse pressure variation (PPV) to predict fluid responsiveness in patients
      undergoing kidney transplantation.
    

Detailed description: 
      Optimal intraoperative fluid management guided by central venous pressure (CVP), a
      traditional intravascular volume status indicator has been established to improve
      transplanted graft function during renal transplantation. Recently, stroke volume variation
      (SVV) and pulse pressure variation (PPV), dynamic preload indices derived from the arterial
      waveform are increasingly advocated as predictors of fluid responsiveness in anesthetized
      patients and critically ill patients. However, their usefulness in renal failure patients
      undergoing renal transplantation has not been investigated. Thus, the aims of this study is
      to investigate accuracy of SVV and PPV for predicting fluid responsiveness in patients
      undergoing kidney transplantation.
    

Intervention name(s): Fluid loading
Intervention type(s): Procedure
Intervention description(s): fluid loading was performed by using 7ml/kg of 6% hydroxyethyl starch within 10 min to all patients
Other intervention name(s): HES 130/0.4; voluven; Fresenius Kabi; Stans, Switzerland
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Fluid Responsiveness; Pulse Pressure Variation; Stroke Volume Variation