bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Constipation in Functional Dyspepsia
Condition: Dyspepsia; Constipation
MeSH terms: Constipation; Dyspepsia
Study type: Interventional

Summary: 
      Background. Functional dyspepsia is characterized by symptoms that apparently originate in
      the stomach without detectable cause by conventional diagnosis test. The pathophysiology of
      functional dyspepsia is not known, but a number of data indicate that dyspeptic patients have
      increased sensitivity of the digestive system, so that physiological stimuli may induce their
      symptoms. Some patients with functional dyspepsia have also functional constipation and the
      investigators hypothesize that in them constipation triggers or facilitates dyspeptic
      symptoms, and consequently, correction of constipation relieves dyspeptic symptoms.

      Objective. To demonstrate the superiority of biofeedback versus a fiber supplement for the
      treatment of dyspeptic symptoms in patients with constipation due to functional outlet
      obstruction.

      Design. Randomized, controlled parallel trial performed in a referral center. Participants.
      Consecutive patients complaining of symptoms of functional dyspepsia and functional outlet
      obstruction.

      Interventions: Patients will be assigned to experimental (biofeedback for functional outlet
      obstruction) and active comparator (fiber supplementation) arms. Biofeedback for functional
      outlet obstruction: sessions of biofeedback guided by anorectal manometry (performed during
      the first 3 weeks of the intervention period) combined with instructions for daily exercising
      for 4 weeks. Fiber supplementation: 2.5 g plantago ovata per day for 4 weeks. Main outcome
      and measures. Clinical symptoms of functional dyspepsia measured by daily questionnaires for
      7 consecutive days before and during the last week of intervention.

      Relevance. Functional Dyspepsia, defined by purely clinical criteria, brings together a
      diverse group of conditions with different pathophysiology. As a result, the treatment is
      empirical and globally inefficient. This study will identify a subset of patients with a
      common pathophysiological mechanism of dyspeptic symptoms (functional outlet obstruction)
      which respond to specific treatment (biofeedback).
    


Intervention name(s): Biofeedback; Fiber supplement
Intervention type(s): Behavioral; Dietary Supplement
Intervention description(s): Functional outlet obstruction will be treated by biofeedback: sessions of biofeedback guided by anorectal manometry combined with instructions for daily exercizing for 4 weeks.; 3.5 g plantago ovata per day will be administered for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Immune Response in Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      This study is designed to evaluate the importance of the immune cells localization
      (distribution) between malignant tumor islets and surrounding stroma and to investigate the
      associations between these immune cells as well as cytokines and clinicopathological and
      prognostic factors of non-small cell lung cancer (NSCLC) patients.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Lithuanian residents who are investigated ant treated in Hospital of Lithuanian University
        of Health Sciences Kaunas Clinics Department of Pulmonology and Immunology and Department
        of Heart, thoracic and vascular surgery
      
Biospecimen description: 
      Blood serum and lung biopsy
    
Keywords: Immune response; Cancer
A Trial of the Jejunal to Ileal Diversion Endoscopic Procedure (Side-to-Side Anastomosis)
Condition: Diabetes
Study type: Interventional

Summary: 
      This is a single center study to assess metabolic effects in subjects after a Jejunal to
      Ileal Diversion procedure was performed using colonoscopes.
    

Detailed description: 
      The Jejunal to Ileal Diversion procedure is an adaptation of a biliopancreatic diversion with
      duodenal switch, which is a surgical procedure used to treat metabolic syndrome conditions.
      The small bowel diversion of the jejunum into the ileum by creating a single anastomosis just
      beyond the ligament of Trietz will be studied. Up to 15 eligible subjects will be enrolled
      into the trial. Enrollment will stop once 10 subjects have undergone the Jejunal to Ileal
      Diversion procedure.
    

Intervention name(s): Jejunal to Ileal Diversion
Intervention type(s): Device
Intervention description(s): The Jejunal to Ileal Diversion procedure will be performed using colonoscopes to place magnets to create a side to side compression anastomosis. The colonoscope delivered magnet creates the proximal end of the anastomosis approximately 100 cm distal from the ligament of Treitz. The colonoscope delivered magnets creates the distal end of the anastomosis approximately 100 cm proximal from the ileocecal junction.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the safety and effectiveness for applying the
      electrical stimulation transcutaneously around the eyes and peripheral nerves nearby. The
      outcomes are compared between the patients with mild- or moderate-level dry eye disease using
      the real electrical stimulator and the sham electrical stimulator.
    

Detailed description: 
      Duration of study period(per participant): Screening period (0-4weeks), Intervention period
      (5weeks).

      Patient needs to visit site at least 3 times (Screening, V4, V6), V2 can be done with
      screening visit.

      The clinical trial device performs a personal electrical stimulator around the eyes and
      peripheral nerves for 28 days (7 times/week, 30 minutes each time).

      During the study period, dry eye examination and treatment methods (only eye drops provided
      in clinical trials are applied) are carried out in the same way.
    

Intervention name(s): Transcutaneous pulsed electrical stimulation (NuEyne 02); Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Arm 1: Experimental: Experimental group: Dry eye disease patients (n=12) Device: Pulse Electrical Stimulation Pulse Electrical Stimulation: Patients wear our clinical trial device 30mins once a day for 4 weeks.; Arm 2: Sham Comparator: Comparison group: Dry eye disease patients (n=12) Device: Sham stimulation Sham stimulation: Patients wear our clinical trial device 30mins once a day for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Rhinoplasty Scar Comparison
Condition: Surgical Incision; Nose Deformity
MeSH terms: Surgical Wound
Study type: Observational

Summary: 
      Traditional suture closure of the columellar scar in rhinoplasty is achieved with permanent
      skin sutures. These sutures create less inflammation and are thought to lead to improved
      final scar outcomes. However, permanent sutures require removal which creates pain and
      inconvenience for the patient. Some surgeons use fast absorbing sutures that do not require
      removal. The difference in final scar outcome based on suture material used has not been well
      studied. This study will examine the final scar outcomes of rhinoplasty incisions sutured
      with traditional permanent suture compared to fast absorbing suture. If scar outcomes are
      similar between these groups as judged by the patients and blinded observers, rhinoplasty
      surgeons may be able to preferentially utilize absorbable sutures for incision closure and
      avoid the pain and inconvenience for the patient during suture removal
    


Intervention name(s): Closure with Permanent Suture; Closure with Resorbable Suture
Intervention type(s): Other; Other
Intervention description(s): Skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.; Skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients seeking rhinoplasty surgery with one of the investigators.
Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State
Condition: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics
      of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a
      non-bleeding state.
    


Intervention name(s): activated recombinant human factor VII; activated recombinant human factor VII
Intervention type(s): Drug; Drug
Intervention description(s): A single bolus dose is administered. Injected intravenously; A random order of a low/high dose of single dose is administered during two PK-assessment periods separated by a washout period of 48 hours to one month. Injected intravenously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the safety and tolerability of two dose levels of a new insulin glargine
      formulation in a once-daily multiple dosing regimen

      Secondary Objective:

      To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new
      insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen
    

Detailed description: 
      The study duration per patient will be 33 to 68 days including 2 treatment periods of 10 days
      each separated by a wash-out period of 7-21 days.
    

Intervention name(s): Insulin glargine HOE901
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:solution for injection: new formulation and marketed formulation Route of administration: subcutaneous
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery
Condition: Acute Kidney Injury (AKI)
MeSH terms: Acute Kidney Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of
      RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing
      cardiac surgery.
    

Detailed description: 
      This is a study with two parallel treatment groups where subjects are randomized to receive
      RMC-035 or a matching placebo in a double-blind fashion. The study will comprise of a
      screening visit, followed by CABG and/or valve replacement on Day 1, double-blind treatment
      period and a follow-up period up to Day 30.
    

Intervention name(s): RMC-035; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple dosing during 48 hours following cardiac surgery; Multiple dosing during 48 hours following cardiac surgery
Other intervention name(s): Solution for injection; Solution for injection
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: AKI
Carnitine Supplementation and Bone Mineral Density
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The primary aim of the current research project is to explore whether carnitine
      supplementation and resistance training may prevent decrements in bone mineral density of
      aged women.

      A secondary aim of this project is to investigate the effect of supplementation on body
      composition and blood markers.
    

Detailed description: 
      The study includes postmenopausal women. The subjects participate in resistance training
      (twice a week) for each session consisted of 6 exercises: horizontal seated leg press, seated
      chest press, leg extension, shoulder press, lat pull-down seated row, seated cable row.

      During the 24-weeks training programme participants are supplemented by carnitine with
      leucine, or leucine alone (placebo).
    

Intervention name(s): L-carnitine; L-leucine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): L-carnitine-L-tartrate; L-leucine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Effect of Milnacipran in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for
      completing complex tasks relative to placebo.
    

Detailed description: 
      Patients with Fibromyalgia will show elevated ventricular lactate levels as measured via
      magnetic resonance spectroscopy (MRS). Patients treated with Milnacipran will show
      normalization of ventricular lactate levels compared to those treated with placebo, and will
      also show normalization of the increased latency to respond to complex reaction time probes
      compared to those treated with placebo.
    

Intervention name(s): Milnacipran; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.; Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
Other intervention name(s): Savella
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis
Condition: Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary aim of this study will be to examine the diagnostic utility of 18-F Florbetapir
      PET/MR (Positron Emission Tomography/Magnetic Resonance) in imaging patients with
      pathologically-confirmed systemic amyloidosis involving the peripheral nerves and compare
      these results to non-amyloid diseased controls.
    

Detailed description: 
      Patients with pathologically proven amyloidosis involving the peripheral nervous system will
      undergo 18-F Florbetapir PET/MR on a GE (General Electric Healthcare) SIGNA PET/MR scanner. A
      control arm comprised of patients with pathologically-confirmed non-amyloid causes of
      peripheral neuropathy will also undergo 18-F Florbetapir PET/MR scanning. all images will be
      reviewed for peripheral nerve uptake.
    

Intervention name(s): 18-F Florbetapir PET/MR scan
Intervention type(s): Other
Intervention description(s): 18-F Florbetapir PET/MR scan, PET/MR on a GE SIGNA PET/MR scanner
Intervention model: Single Group Assignment
Intervention model description: Participants with biopsy proven peripheral nerve amyloidosis will undergo an F-18 Florbetapir PET/MR scan
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Peripheral Nerve Amyloidosis
Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®
Condition: Botulism
MeSH terms: Botulism
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2, open-label, uncontrolled study designed to evaluate safety, tolerability, and
      immunogenicity of a single dose of rBV A/B in healthy participants previously immunized with
      pentavalent botulinum toxoid (or pentavalent botulinum toxoid and rBV A/B) for occupational
      protection will be conducted to collect source plasma for potential use in the production of
      BabyBIG and to evaluate safety and immunogenicity of the vaccine in these participants over a
      12-week period, with a follow-up safety assessment at 6 months.
    


Intervention name(s): rBV A/B
Intervention type(s): Biological
Intervention description(s): Recombinant Botulinum Vaccine A/B, rBV A/B
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Intraosseous Access
Condition: Intraosseus Access; Manikin; Resuscitation
Study type: Interventional

Summary: 
      The investigators will compare the success rates and time to successful IO access during
      simulated adult resuscitation.
    


Intervention name(s): NIO Adult device; Bone Iniection Gun; EZ-IO; Jamshidi Intraosseous Needle; Cook Intraosseous Needle
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): IO access-1; IO access-2; IO access-3; IO access-4; IO access-5
Other intervention name(s): NIO; BIG; Jamshidi; Cook
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Chronic Effects of Exercise on Motor Memory Consolidation in Elderly People
Condition: Elderly
Study type: Interventional

Summary: 
      The main purpose of this study was to investigate if a six months period of physical exercise
      could improve motor memory consolidation in elderly people.
    

Detailed description: 
      38 subjects of both genders, with a mean age of 71 years old participated in the study.
      Subjects were divided in two groups: a control group and an experimental group. Before the
      intervention of a physical exercise program, subjects performed a Finger Tapping Sequence to
      measure baseline performance. After the intervention, the assessment of the impact of
      exercise on motor memory consolidation was held in three stages: Training; 1 hour after
      training and 24 hours after training.
    

Intervention name(s): Motor memory consolidation
Intervention type(s): Other
Intervention description(s): Subjects were divided in two groups: a control group and an experimental group. Before the intervention of a physical exercise program, subjects performed a Finger Tapping Sequence to measure baseline performance. After the intervention, the assessment of the impact of exercise on motor memory consolidation was held in three stages: Training; 1 hour after training and 24 hours after training.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Supplementation of Vitamin D3 on Inflammation Induced by 100 km Running, Iron Metabolism and Erythropoiesis
Condition: Inflammation; Muscle; Iron Metabolism; Ineffective Erythropoiesis; Healthy
MeSH terms: Myositis; Inflammation
Study type: Interventional

Summary: 
      A group of runners received vitamin D (10,000 IU - international unit per day) for two weeks.
      The aim of the intervention was to check the effect of vitamin D supplementation on selected
      parameters of inflammation and iron metabolism in comparison with the placebo group. Blood
      was collected before and after supplementation. Next: before, after 25, 50, 75,100 km running
      and 12 hours after the run. The data were subjected to statistical analysis.
    

Detailed description: 
      Subjects were randomized to two groups: the experimental one, n = 20 and the placebo one, n =
      20 with the same age, experience in running and 25(OH)D level. The experimental group
      received vitamin D3 supplementation (around 10,000 UI/day, i.e., 20 droplets -Vigantol
      medicament, Merck) and the control group received a placebo (20 droplets of sunflower oil,
      placed in an identical bottle as vitamin D3) for two weeks before a run. The last vitamin D
      dose was taken 24 h before the 100 km ultra-marathon. 40 male athletes took part in the 100
      km ultra-marathon. Blood was collected before (day 0) and after supplementation (day 14).
      Next (day 15): before, after 25, 50, 75,100 km running and 12 hours after the run (day 16).
      The data were subjected to statistical analysis.
    

Intervention name(s): Cholecalciferol; placebo
Intervention type(s): Drug; Other
Intervention description(s): cholecalciferol 10000 UI; sunflower oil
Other intervention name(s): Vitamin D3
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Vitamin D; Running; inflammations; erythropoietin; iron; hepcidin
Reference Curve on Bone Mineral Density in Men
Condition: Bone Mineral Density; Grip Strength; Physical Performance
Study type: Interventional

Summary: 
      In men, the hope of lower life, the absence of equivalent of menopause and the existence of a
      higher peak bone mass are the three factors that explain the lower incidence of osteoporosis
      in men.
    


Intervention name(s): Bone densitometry measurement
Intervention type(s): Diagnostic Test
Intervention description(s): Bone densitometry and measurement of body composition
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other