bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Glucagon Administered in Different Forms and Routes to Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study was to evaluate the safety and tolerability of nasal glucagon
      (NG). The study drug was delivered into the participant's nostril (intranasally) or was given
      as an injection just under the skin (subcutaneously) once in each of four study periods. The
      study lasted about 23 days for each participant.
    


Intervention name(s): Nasal Glucagon; Glucagon
Intervention type(s): Drug; Drug
Intervention description(s): Administered intranasally.; Administered SC.
Other intervention name(s): AMG 504-1; LY900018
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Compare the Pharmacokinetic Characteristics and the Safety Between Zeropix and Champix in Healthy Adult Male Subjects.
Condition: Smoking, Cigarette
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, open-label, 2-way, 2-period, single-dose crossover clinical study
      to compare the pharmacokinetic characteristics and the safety between zeropix tablet 1 mg and
      champix® tablet 1 mg in healthy adult male subjects
    


Intervention name(s): Zeropix; Champix®
Intervention type(s): Drug; Drug
Intervention description(s): administration of Zeropix; administration of Champix®
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Behavioral Therapy for Reduction in Smoking Craving
Condition: Smoking Cessation; Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The objective of this pilot research is to investigate the effects of two behavioral smoking
      cessation programs on aspects of cue-induced cigarette craving, and to further investigate
      the neural bases of such effects.
    

Detailed description: 
      The objective of this pilot research is to investigate the effects of two behavioral smoking
      cessation programs on aspects of cue-induced cigarette craving, and to further investigate
      the neural bases of such effects. The specific objectives of the study include 1) to
      investigate the effects of behavioral therapy on cue induced craving using a cognitive task
      and a fMRI paradigm 2) to pilot test questionnaires and study procedures, and 3) to gather
      preliminary estimates of the effect size of the novel behavioral therapy for smoking
      cessation in order to inform the design of a larger trial. A secondary goal of this research
      is 1) to determine the impact of two cognitive coping techniques on attentional bias to
      smoking related cues as measured by behavioral responses and patterns of neural activation
      and 2) to determine the impact of two cognitive coping techniques on cue-induced cigarette
      craving as measured by self-report and patterns of neural activation. Daily smokers desiring
      to quit smoking were randomized to one of two behavioral smoking cessation programs: (1)
      standard cognitive behavioral therapy or (2) mindfulness-based cognitive therapy.
      Participants completed questionnaires and a brief computer-based cognitive testing paradigm.
      Participants also underwent a fMRI scan at quit day (week 5). A randomly assigned subset of
      the participants (n= 18), underwent two additional scans at baseline (week 1) and
      end-of-therapy (week 8). The study has thus used self-report measures, cognitive testing
      (Stroop task), and fMRI (functional magnetic resonance imaging) assessments.
    

Intervention name(s): standard cognitive behavioral therapy; Mindfulness Based Cognitive Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Standard therapy to help participants with smoking cessation.; A novel mind body therapy that extends basic CT principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking cessation; Tobacco dependence; Mindfulness; fMRI; Craving
Energy Expenditure Pre and Post Bariatric Surgery
Condition: Bariatric Surgery
Study type: Observational

Summary: 
      Obese patients are going to be submitted to indirect calorimetry pre-operatively and we are
      going to repeat the same exam 6 months after bariatric surgery (post Roux-en-Y gastric Bypass
      surgery). They are going to do also body composition analysis in both moments.

      The investigators are going to compare the results to see if the bariatric surgery increases
      their energy expenditure.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obese petiets
      
Keywords: energy expenditure; morbid obesity; bariatric surgery; nutritional follow-up
Metabolic Adaptations to Diabetes in African Americans
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      We do not know why diabetic patients cannot protect themselves against low blood sugar.
      Therefore, in this study, we will perform a comprehensive assessment of the body's response
      to low blood sugar by measuring changes in blood hormones, blood sugar production, and nerve
      signals.
    

Detailed description: 
      Morning and afternoon hypoglycemic episodes of 70, 60, or 50 mg/dl produce increased blunting
      of subsequent counterregulation dependent upon the depth of preceding hypoglycemia. We wanted
      to test this hypothesis in healthy African American individuals to determine if there is a
      difference in their responses to varying depths of hypoglycemia.
    

Intervention name(s): glucose clamp; glucose clamp; glucose clamp; glucose clamp
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): 2 hour hyperinsulinemic euglycemic clamp (90 mg/dl); 2 hour hyperinsulinemic hypoglycemic clamp (70 mg/dl); 2 hour hyperinsulinemic hypoglycemic clamp (60 mg/dl); 2 hour hyperinsulinemic hypoglycemic clamp (50 mg/dl)
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Keywords: hypoglycemia; African Americans
Fish Collagen Peptide Food Supplement on Weight and Body Composition
Condition: Weight Management; Food Complement
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      Fish collagen hydrolysates or peptides orally administered have been investigated in recent
      clinical trials in human health. These peptides have been evaluated in various biological and
      medical fields including skin aging, osteoarticular apparatus, muscle and more recently in
      energy metabolism in both animals and humans.

      However, very few studies investigated the effect of fish collagen peptides on weight, body
      composition or glycemic response. Recently, it has been shown that the consumption of fish
      collagen peptides (Naticol®) limits weight gain and increase in fat mass in a mouse model
      made obese by a hyperlipidic diet. Since these results have never been observed in humans,
      this pilot study proposes to answer this question.
    


Intervention name(s): Placebo supplement; Naticol supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of a non active food complement during 3 months.
Tests performed :
2 blood tests :
2 body composition analysis via Dual-energy X-ray absorptiometry (DXA)
2 stool collections The first one of these analysis was performed at the beginning, second at the end of the study.; Consumption of the active food complement during 3 months containing Naticol.
Tests performed :
2 blood tests :
2 body composition analysis via Dual-energy X-ray absorptiometry (DXA)
2 stool collections The first one of these analysis was performed at the beginning, second at the end of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Emergency Department Ultrasound in Renal Colic
Condition: Renal Colic; Hydronephrosis; Abdominal Aortic Aneurysm
MeSH terms: Hydronephrosis; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Colic; Emergencies; Renal Colic
Study type: Observational

Summary: 
      Renal colic is a common (1300 visits per year at our institution) and painful condition
      caused by stones in the kidney and ureter, and can be mimicked by life threatening conditions
      such as a ruptured abdominal aortic aneurysm (AAA). This can create clinical uncertainty.
      Emergency department targeted ultrasound (EDTU) is performed by an emergency physician at the
      patient's bedside, and has been shown to be accurate, safe, and efficient. We have shown that
      EDTU can accurately identify hydronephrosis, which is a predictor of complications of kidney
      stones. A normal formal ultrasound (US) predicts an uncomplicated clinical course. We will
      assess the accuracy of EDTU for the diagnosis of hydronephrosis, and when normal, whether
      patients can be safely discharged.
    


Intervention name(s): EDTU
Intervention type(s): Procedure
Intervention description(s): bedside ultrasound imaging by the treating emergency physician
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ED patients with suspected renal colic being imaged while in the ED
      
Keywords: renal colic; hydronephrosis; abdominal aortic aneurysm; ultrasound; emergency medicine; urolithiasis
Validation of the Ipsilateral Nipple as the Directional Guide for Internal Jugular Vein (IJV) Catheterization
Condition: Ipsilateral Nipple; Internal Jugular Vein; Catheterization
Study type: Observational

Summary: 
      Traditional teaching that suggests the ipsilateral nipple as the directional guide for needle
      advancement during Internal Jugular Vein (IJV) catheterization has weak grounds.

      The investigators attempt to validate this long-standing statement.
    


Intervention name(s): SCM triangle - ipsilateral nipple
Intervention type(s): Procedure
Intervention description(s): draws the tract of the IJV using the SCM triangle head and the ipsilateral nipple
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients scheduled to undergo general anesthesia
Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Condition: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
MeSH terms: Prostatitis; Syndrome; Pelvic Pain; Chronic Disease; Somatoform Disorders
Study type: Interventional

Summary: 
      Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refers to the presence of
      bothersome pelvic pain symptoms without an identifiable cause. Common symptoms of CP/CPPS
      include discomfort in the perineum, suprapubic region, and lower urinary tract symptoms. It
      affects men of all ages without apparent racial predisposition, among which, 36-50 years old
      are the most commonly influenced. Yet, few effective therapies are available for treating
      CP/CPPS.

      Acupuncture may be an effective treatment option for CP/CPPS. However, effects of acupuncture
      on CP/CPPS remain uncertain because of the small sample sizes or other methodological
      limitations.

      The objective of this multi-centre, randomized, sham acupuncture-controlled trial is to
      assess the effectiveness of acupuncture for relieving symptoms of CP/CPPS. The results will
      provide a robust conclusion with a high level of evidence.
    


Intervention name(s): Acupuncture; Sham acupuncture
Intervention type(s): Device; Device
Intervention description(s): For acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol.
Acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).; For sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35.
Sham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic prostatitis; chronic pelvic pain syndrome; acupuncture; randomized controlled trial
Bioequivalence Between a Racecadotril Capsule and Film-Coated Tablet (FCT) to Treat Diarrhea in Adults
Condition: Antidiarrheals
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess bioequivalence between two products used for treatment of
      acute diarrhea.
    

Detailed description: 
      The study will be a single dose, randomized, two-way crossover study in 40 healthy subjects,
      with equal numbers of males and females (minimum of 18 of either gender). Drop-outs will not
      be replaced. The two doses of medication given in the study (a single dose in each of the two
      study periods) will be separated by a washout period of at least 7 calendar days. In each
      study period, twenty (20) blood samples for pharmacokinetic analysis and, for the first 8
      male and 8 female subjects included in the study (total of 16 subjects), seven (7) blood
      samples for pharmacodynamic analysis will be taken over 24 hours. Blood samples will be
      centrifuged and concentrations of thiorphan in plasma will be measured using a validated
      chromatographic assay. Pharmacokinetic parameters will be calculated from plasma
      concentration data. The rate and extent of absorption of the formulations will be compared.
    

Intervention name(s): Racecadotril Film-Coated Tablet (FCT); Racecadotril Capsule
Intervention type(s): Drug; Drug
Intervention description(s): A single 100 mg dose of an experimental Racecadotril FCT administered orally with 240 ml of water, with a 7- day washout between visits; A single 100 mg dose of a marketed Racecadotril capsule administered orally with 240 ml of water, with a 7-day washout between visits
Other intervention name(s): Not yet marketed; Tiorfast®
Intervention MeSH terms: Racecadotril; Thiorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
GNRH Agonist Trigger and Modified Luteal Phase Adding a Bolus of GnRHa at the Time of Implantation: a RCT
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Purpose:The aim of this project is to prospectively determine whether a single dose of
      GnRH-agonist administered at the time of implantation increases or not the reproductive
      outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm
      injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic
      gonadotropin (hCG 1500 IU) the day of oocyte retrieval.
    

Detailed description: 
      It has been reported in previous publications that the ovarian hyperstimulation syndrome
      (OHSS) was eliminated when GnRH agonist was used to trigger ovulation and the delivery rate
      has improved after modified luteal support especially when a small bolus of hCG is used on
      the day of oocyte retrieval. (OMEGA/HCG 1500 IU).

      However, a risk difference of 7% in delivery rates is still in favor of HCG trigger. Thus,
      further modifications in the luteal phase supplementation are required in order to optimise
      the reproductive outcome after GnRH-agonist triggering.

      Recently, many papers showed, that independently of the GnRH analogue used to prevent the
      premature LH surge, the addition of GnRH-agonist during the luteal phase seems to be
      beneficial in terms of pregnancy. Nevertheless, their use in practice is not yet admitted
      because of controversial results in terms of efficacy and safety particularly on the
      conceptus.
    

Intervention name(s): Triptorelin 0.1 mg
Intervention type(s): Drug
Intervention description(s): a single dose of Triptorelin 0.1 mg subcutaneously administered 6 days after oocyte retrieval.
Other intervention name(s): Decapeptyl 0.1 mg
Intervention MeSH terms: Triptorelin Pamoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GnRH agonist trigger; IVF; Luteal phase support; Mid-luteal GnRH agonist
Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The position of the femoral tunnel in anterior cruciate ligament (ACL) reconstruction has
      been assessed on three dimensional CT (3D-CT) scan or in cadaveric study. However, these
      methods have some issues; 3D-CT scan has a concern on radiation exposure and cadaveric study
      is not easily available nor an in vivo test. The purpose of this study is to compare the
      position of the femoral tunnel aperture on conventional MRI and the outcomes after single
      bundle ACL reconstruction using free tendon Achilles allograft between transportal technique
      and transtibial technique in active young men.
    


Intervention name(s): transtibial technique; Transportal technique; anterior cruciate ligament reconstruction
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Femoral tunnel was made via tibial tunnel in anterior cruciate ligament reconstruction.; Femoral tunnel was made via anteromedial portal in anterior cruciate ligament reconstruction.; femoral and tibial tunneling graft fixation on the femoral side with endobutton and on the tibial side with post-tie and interference screw
Other intervention name(s): anteromedial portal technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis
Condition: Ulcerative Colitis; Proctitis
MeSH terms: Colitis; Colitis, Ulcerative; Proctitis; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases that
      involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular.
      Likewise IBD is characterized by chronic tissue inflammation, tissue damage and ulcerations
      in various extents. Therefore we hypothesize that LLLT might be effective in treating IBD and
      the Photopill capsule was developed for this purpose.

      An open-label, interventional, clinical trial was designed for assessment of the safety and
      feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative
      Proctitis.

      Primary endpoints being: safety reflected by the number and severity of adverse events and
      mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition.

      Furthermore clinical and biochemical parameters are monitored during the study.
    


Intervention name(s): Photopill treatment
Intervention type(s): Device
Other intervention name(s): Photopill
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; Ulcerative Proctitis; Low Level Light Therapy; Safety; Efficacy
Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with type 1 diabetes (T1D) depend on insulin therapy as substitution for the lack of
      endocrine insulin production due to an autoimmune destruction of beta-cells in the pancreatic
      inslets. Insulin therapy is based on long lasting basal insulin for controlling fasting
      plasma glucose, and short lasting mealtime insulin for the postprandial plasma glucose. The
      long term efficacy of this treatment is measured in glycated haemoglobin A1c (HbA1c) of <7.0%
      as the treatment goal.

      Intensive insulin therapy is associated with side effects such as hypoglycaemia, weight gain,
      and unwanted exaggerated excursions in PPG. This may ultimately affect treatment compliance.

      The abovementioned problems associated with insulin treatment in T1D can also be seen in
      insulin-treated patients with type 2 diabetes (T2D). However, in T2D the combination of
      insulin with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) has proven effective in
      reducing the weight gain and insulin dose in insulin-treated patients with T2D without
      exacerbating the risk of hypoglycaemia.

      Exenatid is a short lasting GLP-1RA approved for treatment in T2D, and the investigators
      intend to evaluate it in a randomized, controlled trial as add-on therapy to standard insulin
      therapy for patients with T1D.

      The investigators hypothesise that the add-on of exenatide to insulin therapy in patients
      with T1D will reduce insulin requirements, glycaemic excursions and body weight and improve
      glycaemic control without increasing the risk of hypoglycaemia.
    


Intervention name(s): Exenatide; Placebos
Intervention type(s): Drug; Drug
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; Exenatide; Incretins; GLP-1; Insulin