bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Soy Protein on Body Composition and General Health in Healthy Children
Condition: Generally Healthy Kids Consumption Soy Protein Foods as Part of Daily Diet
Study type: Interventional

Summary: 
      The aim of this clinical trial is to assess the effects of daily consumption of soy protein
      foods on body composition, general health status and dietary intake outcomes in generally
      healthy children.
    


Intervention name(s): Soy protein containing foods; Dietary Guidance
Intervention type(s): Other; Behavioral
Intervention description(s): Daily consumption of 2 food products, each providing 15g of soy protein per day.; Subjects will be instructed on the 2010 Dietary Guidelines for Americans including publically available information from the United States Department of Agricultural (USDA) MyPlate program (www.choosemyplate.gov). Subjects in this intervention group will not receive study provided foods.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Study of HTD4010 in Healthy Volunteers
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety and tolerability of HTD4010 after single ascending doses (SAD) in
      healthy volunteers
    

Detailed description: 
      Safety, tolerability and pharmacokinetics(PK) assessments are the outcome measure.
    

Intervention name(s): HTD4010
Intervention type(s): Drug
Intervention description(s): injectable solution
Other intervention name(s): analog of INGAP peptide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nasogastric Tube Securement Comparison Study
Condition: Failure to Thrive; Nutritional Deficiency; Constipation; Bowel Obstruction; Feeding and Eating Disorders
MeSH terms: Intestinal Obstruction; Malnutrition; Constipation; Failure to Thrive; Feeding and Eating Disorders
Study type: Interventional

Summary: 
      This study evaluates the use of tape to secure nasogastric tubes compared to securement with
      a nasal bridle device.
    

Detailed description: 
      Patients who need to have a tube placed through their nose and into their stomach for medical
      treatments will sometimes have it accidentally removed. A nasal bridle is a device where a
      magnetic is used to attach a small piece of cloth tape that loops around the nasal septum
      bone and secures to the nasal gastric tube to prevent it from being pulled out accidentally.
    

Intervention name(s): Nasal Bridle
Intervention type(s): Device
Intervention description(s): Nasal bridle placement and securement of the tube. Instead of taping the tube to the patient's face, nose or upper lip the bridle is a device whereby a magnetic retrieval system is attached to 1/8 inch umbilical tape which is inserted via the nares, looping around the nasal septum and vomer bone and ending with both ends of the bridle (umbilical tape) secured together and to the feeding tube just outside the nose.
Other intervention name(s): Microbridle
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Evaluate the securement of the Nasogastric tube either by standard securement or using a Nasal Bridal securement method.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: nasogastric tube; microbridle
High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)
Condition: Primary Immunodeficiency Disease
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III
      study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks,
      continuing the patient's infusion interval in the main study NCT01012323 [NGAM-01]) for 3
      months. The primary objective of the study was to assess the safety and tolerability of high
      infusion rates of NewGam.
    

Detailed description: 
      Patients received NewGam via an infusion pump to control precise infusion rates. All NewGam
      infusions started at a rate of 0.01 mL/kg/min (60 mg/kg/h) for the first 30 minutes followed
      by 0.03 mL/kg/min (180 mg/kg/h) for the next 15 minutes. If tolerated, further increments
      were made at predefined patterns with the following maximum rates: 0.10 mL/kg/min (600
      mg/kg/h) in the first infusion; if this was tolerated, 0.12 mL/kg/min (720 mg/kg/h) in the
      second infusion; if this was tolerated, 0.14 mL/kg/min (840 mg/kg/h) in all subsequent
      infusions.

      If an adverse event occurred during an infusion, the rate was reduced to half the rate at
      which the event occurred or the infusion was interrupted until symptoms subsided. The
      infusion was then resumed at a rate tolerated by the patient.
    

Intervention name(s): NewGam
Intervention type(s): Biological
Intervention description(s): The initial dose and dosing interval for each participant was the dose and dosing interval the participant received at the end of the NGAM-01 study. The dose of NewGam, solvent/detergent treated human normal immunoglobulin 10%, remained the same throughout the study, as long as the minimum trough level of serum immunoglobulin G (IgG) was above 5 g/L. If the serum IgG trough level dropped to 5 g/L or less, the dose was to be adjusted at the investigator's discretion. NewGam was supplied as a solution for infusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Immunodeficiency Disease; PID
IL15 Dendritic Cell Vaccine for Patients With Resected Stage III (A, B or C) or Stage IV Melanoma
Condition: Malignant Melanoma Stage III; Malignant Melanoma Stage IV
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to gather data on feasibility as well as immune and clinical
      efficacy of of a dendritic cell vaccine using IL15 in patients with resected stage III or
      stage IV melanoma
    

Detailed description: 
      IL15 is a T cell growth factor that pre-clinical data overwhelmingly suggests could have a
      very important role in cancer immunotherapy. A desirable property for a dendritic cell
      vaccine directed against cancer is the ability to efficiently prime naïve, tumor associated
      antigen specific T cells into potent CTLs. Results of studies in healthy volunteers have
      shown that IL15 DCs are particularly efficient at priming functional melanoma specific CD8+ T
      cells. The use of IL15 in the manufacture of the DC vaccine could result in an improved
      immunotherapy product.
    

Intervention name(s): IL15-DC Vaccine
Intervention type(s): Biological
Intervention description(s): Autologous dendritic cells manufactured with GM-CSF, IL15 and loaded with melanoma/HIV peptides and KLH; then activated with LPS and CD40 Ligand. Approximately 9 x 10^6 DCs will be injected (subcutaneously)total per vaccination visit. Patients will receive four vaccinations at weeks 0, 4, 8 and 12. At each scheduled vaccination the patient will receive a total of 3 injections, i.e., 3 mL injections at each of 3 anatomical locations.Injection sites are in upper and lower extremities. Subsequent DC injections will be rotated to different locations on the upper and lower extremities.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma; Vaccine; Dendritic Cell; Immune response; Safety; Efficacy
An Study to Examine the Effect of Coated Suppositories on Anal Pressure in Healthy Subjects
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open label, dose-finding, 2-parts study. Approximately 6 subjects will be
      participating in this study. This study is composed of 2 parts:

      Part 1 is a dose finding study. Part 2 is a pharmacodynamic and pharmacokinetic study of an
      elected dose. A screening will be used to determine patients' suitability for inclusion in
      the trial. Within one week after the screening visit, subjects who meet all inclusion
      criteria and none of the exclusion criteria will enter part 1 of the study, one day of dose
      escalation. During this part, patients will undergo rectal manometry to determine anal
      pressure at baseline. Afterwards coated suppositories at various drug concentrations will be
      inserted and follow up manometries will be performed to determine response.

      Patients that presented with an increase in rectal resting pressure without adverse events
      will enter the second part of the study. In this part, patients will be administered with a
      coated suppository, at a dose found at part 1 of the study to cause significant anal
      contraction. Manometry studies will be performed before insertion (baseline) and at 1, 3 and
      5 hours after insertion.

      Blood levels for drug concentrations will be taken at times 0, 30, 60, 120, 180, 300 minutes
      after administration and rectal manometries will be done at times 0, 1, 3 and 5 hours after
      administration.
    


Intervention name(s): coated suppository
Intervention type(s): Drug
Intervention description(s): Dose escalating study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of a Vitality Dietary Supplement on Physical and Mental Function in Middle-aged Adults
Condition: Health-related Quality of Life
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effects of 8 weeks Vitality Product
      supplementation on physical and mental function in middle-aged adults
    


Intervention name(s): Vitality Product; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Proprietary blend of ginseng, cordyceps, and pomegranate taken twice a day for 8 weeks; Placebo taken twice a day for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers
Condition: Cognitive Impairment; Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study explores the safety, pharmacodynamics and pharmacokinetics of THN201 a combination
      of donepezil and mefloquine to improve cognitive function in healthy male volunteers after
      impairment by a scopolamine challenge.
    

Detailed description: 
      This is a double-blind, 3-arm, parallel group study of 15 days duration including a
      scopolamine challenge at D15. Healthy male subjects will receive daily doses of THN201
      (donepezil 5 mg and mefloquine), donepezil 5 mg or placebo and one subcutaneous injection of
      scopolamine 0.5 mg on D15. Cognitive function, EEG and P300 will be assessed at baseline and
      before and after scopolamine challenge at D15. A final safety evaluation will be performed 2
      weeks after the end of the treatment period. Pharmacokinetic assessments will be performed to
      obtain a time/concentration profile of donepezil and mefloquine.
    

Intervention name(s): THN 201; Donepezil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): THN 201: Donepezil 5 mg and Mefloquine 10 mg/d; Donepezil 5 mg/d and Mefloquine placebo; Donepezil placebo and Mefloquine placebo
Other intervention name(s): Donepezil; Mefloquine
Intervention MeSH terms: Mefloquine; Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients
Condition: Transplant; Diabetes
Study type: Interventional

Summary: 
      The purpose of this study is to understand how the pancreas functions after transplantation
      and particularly why high blood sugar levels develop. It will also analyze the effect of the
      medicines used to prevent rejection on blood sugar levels.

      The hypothesis to be tested is that hyperglycemia more than six months after successful
      pancreas transplant results from a defect in insulin secretion, insulin resistance, or both.
    

Detailed description: 
      Type I diabetes mellitus (DM1) is an autoimmune disease characterized by destruction of the
      insulin-secreting beta cells. Insulin replacement has been the cornerstone of therapy for
      patients with DM1. However, pancreas transplantation, utilizing the whole pancreas as a means
      to replace the destroyed beta cells, has become a therapeutic alternative. The goal of
      pancreas transplantation is the establishment of long-term euglycemia, thereby preventing or
      allowing for the repair of end-organ complications.

      Maintenance of the pancreas allograft over many years remains the goal in following pancreas
      transplant recipients over time. The onset of hyperglycemia less than one year after
      transplant is usually due to issues of surgical technique or acute rejection. However, the
      onset of hyperglycemia after one year of pancreas transplant is more problematic because the
      underlying causes are less clear and have been less well characterized. Currently, there is
      no protocol for definitively identifying the causes of hyperglycemia in pancreas transplant
      recipients over one year. This project will systematically characterize beta cell function
      and peripheral tissue response to insulin in patients who have received an earlier successful
      pancreas transplant who have developed hyperglycemia.
    

Intervention name(s): Oral glucose tolerance test; IV Glucose Tolerance Test
Intervention type(s): Procedure; Procedure
Intervention description(s): test done over 2 hours; Done over 4 hours
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: euglycemic; transplant; pancreas; hyperglycemic; kidney
Effects of Peripherally Acting µ-opioid Receptor Antagonists on Acute Pancreatitis
Condition: Acute Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will investigate the effect of peripheral acting opioid antagonist (PAMORA) on the
      disease course of patients with acute inflammation of the pancreas (acute pancreatitis). The
      study will be conducted by treating hospitalized patients with acute pancreatitis with a
      PAMORA (methylnaltrexone).
    

Detailed description: 
      In this study, the effects of peripheral acting µ-opioid receptor antagonists (PAMORA) on
      disease development and progression in patients with acute pancreatitis (AP) will be
      investigated. Patients with AP will be administered Methylnaltrexone (Relistor®)
      intravenously. This medication is defined as the investigational product. Relistor® is
      approved and sold on the Danish marked for treatment of opioid-induced constipation. This
      PAMORA have not previously been investigated in patients with pancreatitis. The dose regimes
      for this study will be according to label. It has previously been shown, in patients with
      opioid-induced obstipation and healthy subjects, that opioid antagonism incl. PAMORA
      treatment increases gut motility, relaxes gastrointestinal sphincters, increases the
      intestinal water content and improves the immune response, without affecting analgesia. The
      affinity of PAMORAs to the µ-opioid receptors is much stronger than opioid analgesics.
      Therefore, they as antagonists have the potential to counteract the harmful effects of
      opioids on the gut mucosa, bacterial translocation and inflammation despite the high levels
      of exogenous opioids present in patients with pancreatitis. PAMORAs do not cross the
      blood-brain barrier and consequently do not interfere with analgesia or other central effects
      of opioids.

      We hypothesize that treatment with the PAMORA methylnaltrexone will antagonize the harmful
      effects of opioids without reducing analgesia in patients with AP and hence reduce disease
      severity and improve clinical outcomes. If successful, this sub-study will for the first time
      document the effects of a targeted pharmacotherapy in AP with the potential benefit of
      improved patient outcomes.
    

Intervention name(s): Placebo treatment; Methylnaltrexone treatment
Intervention type(s): Drug; Drug
Intervention description(s): Active drug/placebo is given for the first 5 days of admission.; Active drug/placebo is given for the first 5 days of admission.
Intervention MeSH terms: Methylnaltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Demonstrate the Relative Bioequivalency of Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioequivalency of comparing single 100 mg doses Of Cord's 50 mg
      Desipramine Hcl tablets to Merrell Dow's 50 mg Norpramin tablets.
    


Intervention name(s): Desipramine HCl 50 mg Tablets Cord Laboratories; Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc
Intervention type(s): Drug; Drug
Intervention MeSH terms: Desipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antidepressant
Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma
Condition: Glaucoma; Ocular Hypertension; Eye Disease
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Eye Diseases; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this dose-escalation study is to evaluate the safety, tolerability and
      efficacy of AMA0076 in reduction of intraocular pressure in subjects with ocular hypertension
      or primary open-angle glaucoma.
    


Intervention name(s): AMA0076; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Post Market Study of DeNovo NT, Natural Tissue Graft
Condition: Cartilage Repair
Study type: Observational

Summary: 
      The purpose of this post market study is to evaluate surgical implantation technique and the
      quality of repair of the cartilage defect with particulated juvenile cartilage in the human
      knee joint.
    

Detailed description: 
      The intent of this post market study is to assess the clinical outcomes of DeNovo NT, a
      particulated juvenile cartilage tissue for the treatment of one or two contained lesion(s)
      equal to an ICRS Grade 3a, 3b, 3c, 3d of the femoral condyle or trochlear groove and OCD
      lesions (Grade 4a) with healed bone base, which is non sclerotic and no loss of bone greater
      thank 6mm measured from the surrounding subchondral plate.
    

Intervention name(s): Particulated Juvenile Cartilage Allograft
Intervention type(s): Biological
Intervention description(s): Particulated Juvenile Cartilage Allograft
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinical population
      
Keywords: ISTO Technologies, Inc; cartilage repair; arthroscopy; 361 HCT/P; human tissue; biologic; knee
A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for
      re-treatment with SAGE-217 in adult participants with MDD.
    


Intervention name(s): SAGE-217
Intervention type(s): Drug
Intervention description(s): SAGE-217
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Resistant Starch Type-3, Glucose Metabolism and Appetite
Condition: Resistant Starch
Study type: Interventional

Summary: 
      Resistant starch (RS) is considered to have many of the same health benefits as dietary
      fiber. The aim of this study was to examine the effects of RS3 on postprandial glycemic and
      insulinemic responses and appetite.

      Healthy males (aged 18-35 years) participated in this study. Subjects were provided meals in
      the laboratory after overnight fasting on two separate occasions, at least 1 week apart. On
      each laboratory visit, subjects were given either a control meal (COM) or an RS3 meal (RSM).
      Both meals during the two visits consisted of vegetarian pasta and were matched for energy
      intake, composition, ingredients, and amount, but were prepared in different ways. The COM
      was hot, freshly cooked pasta, while the RSM was re-heated pasta that had been cooked the
      previous day and chilled overnight. Blood samples and subjective appetite ratings were
      collected at fasting and for a period of 3 h after meal consumption (i.e., 15-min intervals
      for glucose and 30-min intervals for insulin, ghrelin, and subjective appetite).
    


Intervention name(s): Dietary intervention
Intervention type(s): Other
Intervention description(s): fresh, hot pasta and re-heated pasta
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Interfascial Pressure Into Ultrasound Guided Anterior Quadratus Lumborum Block Application
Condition: Block
Study type: Interventional

Summary: 
      The block has been shown to be the result of abdominal analgesia as a result of application
      between the quadratus lumborum (QL) muscle and the leaves in the thoracolumbar fascia.

      In this block, local anesthetic drugs are administered between the quadratus lumborum (QL)
      muscle and the anterior leaf in the thoracolumbar fascia.

      In this way, it has been reported that it provides a good analgesia as it relieves somatic
      pain better in upper and lower abdominal surgeries.
    

Detailed description: 
      The mechanism of QLB analgesic contains many theories. This study includes the research
      relationship between the effect of fascial pressure and the success of the association block.
      We will use the ultrasound guided anterior Quadratus Lumborum Block. A peripheral nerve block
      catheter will be placed between the quadratus lumborum muscle and the psoas muscle with
      ultrasound.The pressure between the fascia and the pressure line added to the catheter tip
      will be measured.A peripheral nerve block catheter will be placed between the quadratus
      lumborum muscle and the psoas muscle with ultrasound. The pressure between the fascia and the
      pressure line added to the catheter tip will be measured.
    

Intervention name(s): inter-fascial pressure
Intervention type(s): Device
Intervention description(s): The pressure between the fascia and the pressure line added to the catheter tip will be measured.
Intervention model: Single Group Assignment
Intervention model description: prospective, cohort
Masking: None (Open Label)
Primary purpose: Diagnostic