bioihbjkbjnl/mcl2 huggingface dataset:
Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this research study is to screen healthy African American and Caucasian
      persons for specific differences in genes that control how fats are processed in the body.
    

Detailed description: 
      Healthy African American and Caucasian persons will be screened for specific differences in
      genes that control how fats are processed in the body. Persons with the needed genotypes will
      be added to a database of healthy persons who may be asked to join a larger study comparing
      differences in diet on lipid metabolism and inflammatory biomarkers as well as future
      studies. A key hypothesis for the larger study is that variations in genes involved in lipid
      metabolism play a role in determining levels of long chain polyunsaturated fatty acids
      (LC-PUFAs).
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Caucasian or African American adults between 21 and 65 years of age
      
Biospecimen description: 
      A small saliva sample for screening purposes will be collected. If documentation from a
      personal physician of blood glucose and lipid levels are unavailable, we will collect a small
      tube (10-12 ml) of blood to determine these measurements.
    
Keywords: healthy adult; genetic variation; botanical oils; polyunsaturated fatty acid; fish oil; fat metabolism; Genetic variation of fat metabolism in healthy adults
Per Oral Endoscopic Myotomy (POEM) for Esophagogastric Junction Outflow Obstruction (EGOO)
Condition: Esophagogastric Junction Outflow Obstruction
Study type: Interventional

Summary: 
      This research is being done to study an endoscopic procedure called "POEM" as a less invasive
      alternative to surgery in people with esophagogastric junction outlet obstruction (EGOO).
    

Detailed description: 
      Patients with EGOO have difficulty swallowing and/or chest pain. Previously we were not able
      to distinguish this disease from achalasia. Achalasia is a disease which is characterized by
      a progressive difficulty with swallowing. It is caused by failure of relaxation of the lower
      esophageal sphincter (sphincter between esophagus and stomach) along with an essentially
      aperistaltic esophageal body.

      However, EGOO patients have abnormal lower esophageal sphincter relaxation with some
      preserved peristaltic activity. Because they have some peristalsis, these patients are not
      diagnosed with achalasia.

      Currently, a new diagnostic method, known as high-resolution manometry (HRM), can identify
      EGOO patients. EGOO patients usually do not respond well to medical treatment and surgery is
      required in most cases to reduce the pressure of lower esophageal sphincter muscles. This
      procedure is called "Heller myotomy".

      Recently, a new endoscopic method for reducing lower esophageal sphincter pressure has been
      developed. This method, per-oral endoscopic myotomy (POEM) is now being performed clinically
      throughout the world, including Johns Hopkins Hospital. The technique utilizes a flexible
      endoscope to tunnel beneath the esophageal surface layer and cutting muscle fibers of the
      lower esophagus and upper stomach. POEM is an alternative to invasive surgery with fewer
      complications. POEM is performed safely at Johns Hopkins Hospital for achalasia patients.
      Outcomes of POEM have been excellent with greater than 90% positively responding to
      endoscopic myotomy. Patients with EGOO are being diagnosed more often due to increased use of
      HRM. They respond poorly to endoscopic therapies but well to surgical myotomy. POEM is the
      endoscopic equivalent to surgical intervention and represents a less invasive approach to
      treating these patients.
    

Intervention name(s): POEM
Intervention type(s): Procedure
Intervention description(s): Patients will receive Per oral endoscopic myotomy (POEM) for symptomatic gastroesophageal junction outflow obstruction (EGOO)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophagogastric junction outflow obstruction; EGOO; Per oral endoscopic myotomy; POEM; Gastroesophageal reflux disease; GERD
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder
Condition: Bipolar I Disorder; Manic Episode
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with
      or without mixed features, in participants with a diagnosis of bipolar I disorder.
    

Detailed description: 
      A multicenter, randomized, double-blind trial of brexpiprazole versus placebo for the acute
      treatment of manic episodes, with or without mixed features, associated with bipolar I
      disorder. This study also demonstrated the safety and tolerability of brexpiprazole in the
      study population of males and females aged 18 to 65 years (inclusive, at time of consent).
    

Intervention name(s): Brexpiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Brexpiprazole was administered orally with flexible dosing from 2 to 4 mg/day; titrated to a maximum of 4 mg/day for 3 weeks.; Administered orally daily for 3 weeks.
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants received a dose of brexpiprazole or placebo for a maximum of 21 days and were evaluated throughout the duration of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brexpiprazole; Bipolar; Manic episode
Cocoa Flavanols and Exercise Capacity
Condition: Exercise Capacity
Study type: Interventional

Summary: 
      The purpose of this study is to characterize the potential improvement of cocoa flavanols on
      exercise capacity in highly trained cyclist. A placebo-controlled double-blinded randomized
      control study will be performed in 13 highly trained cyclist (crossover design). Participants
      will perform a baseline exercise testing on an ergometer. They will receive either a
      flavanol-poor or flavanol rich cocoa drink twice daily for one week before a second and third
      exercise testing is performed. The order of drinks is randomized and balanced
      (high-flavanol-->low-flavanol drink or low-flavanol drink-->high-flavanol drink)
    

Detailed description: 
      13 participants (highly-trained cyclist, accustomed to exercise testing on ergometers will be
      enrolled (VO2max>50 ml/kg, FMD >5%, non-smokers, no medication, no diseases, age 20-36,
      male).

      Baseline Testing:

      Participants will perform a baseline testing consisting of an ergometric test with a
      step-wise increase of workload until exhaustion to determine lactate anaerobic threshold and
      cardio-pulmonary exercise capacity. Vascular function is monitored by Doppler Ultrasound.

      In a second test, participants will perform a time trial (goal: as fast as possible)

      Flavanol intervention Participants will twice daily receive either a flavanol-poor cocoa
      drink (13mg/dl)or a flavanol-rich cocoa drink (596mg/dl) over a period of 7 days. Order is
      randomized and balanced. Subjects will crossover to the second arm after a washout period of
      7 days.

      Testing performed on baseline day is repeated after the intake of both drinks

      In a subgroup of n=6 participants, we will test whether the blood pressure cuff maneuver used
      for FMD will itself modify nitrite levels. For this the manuever will be completed 4 times
      and compared to n=6 untreated controls. in another subgroup 6 participants will receive
      4times the maneuver but reperfusion will be limited by means of an ultrasound probe.
    

Intervention name(s): Cocoa
Intervention type(s): Other
Intervention description(s): dissolved in water twice-daily intervention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: trained cyclists; no medications; no diseases; non-smokers
Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma
Condition: Risk for Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Adenoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immune response to MUC1 - poly-ICLC vaccine, an
      investigational or study vaccine. The MUC1 - poly-ICLC vaccine is being tested in persons
      with a history of advanced adenomatous polyps, the precursor to colorectal cancer. The MUC1 -
      poly-ICLC vaccine is being developed to prevent polyps from advancing into colon cancer and
      to prevent polyps from recurring.

      MUC1 is mucus that is normally present on the lining of the human colon. However, MUC1 is
      expressed in a larger amount and in a modified form on adenomatous polyps and colorectal
      cancer. These changes in MUC1 are thought to be part of the process of progression from
      adenomas toward cancer. The goal of a vaccine is to help the immune system in the body
      identify the changes in MUC1 that accompany the progression to cancer and eliminate the
      abnormal cells that make abnormal MUC1.
    

Detailed description: 
      This is a phase II trial designed to assess antibody and T cell responses to MUC1 vaccine
      among subjects at increased risk for colorectal cancer by virtue of a history of advanced
      adenoma. The primary objective is to evaluate the immunogenicity of a combination of the
      100mer MUC1 peptide and adjuvant Poly-ICLC in boosting the immune response to MUC1. Among the
      secondary objectives is to determine if anti-MUC1 immunity, preexisting or vaccine induced,
      has an effect on the recurrence of polyps. Subjects with a history of advanced adenoma will
      be recruited for MUC1 vaccination. Vaccine will be administered at weeks 0, 2, and 10. Some
      subjects may have pre-existing immunity to MUC1, and this will be accounted for in the
      analytic phase. However, all subjects will be administered the vaccine, regardless of
      baseline antibody status. To insure accurate standardization in measurement and assessment of
      antibody levels, assays for baseline antibody status will be done at the same time as those
      for response to vaccine.
    

Intervention name(s): MUC1 - Poly ICLC
Intervention type(s): Biological
Intervention description(s): The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Intervention MeSH terms: Poly ICLC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention; Colorectal Cancer
Interaction Between St John's Wort and Metformin?
Condition: Type 2 Diabetes; Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of the study is to examine the difference of the pharmacokinetics of metformin with
      and without a 3 weeks pretreatment of St John's Wort. Furthermore secondary objectives
      include changes in GLP-1, C-peptide, serum-insulin and plasma-glucose during an oral glucose
      tolerance test, changes in OCT1 mRNA in plasma and changes in leptin and lipid-profile
      following this possible interaction.
    


Intervention name(s): St John's Wort; Metformin
Intervention type(s): Other; Drug
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to determine if inhaled insulin is effective in treating type 2 diabetes
      mellitus.
    


Intervention name(s): Insulin glargine; Inhaled Insulin (Exubera)
Intervention type(s): Drug; Drug
Intervention description(s): Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.; Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin Glargine Diabetes HbA1c
Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin on the Neck
Condition: Wrinkles
Study type: Interventional

Summary: 
      Study is a prospective clinical trial to evaluate the efficacy of the Ulthera® System to
      improve Lifting Skin on the Neck. Changes from baseline in the FACE-Q Appraisal of Neck scale
      score and Global Aesthetic Improvement Scale scores will be assessed at study follow-up
      visits.
    

Detailed description: 
      Before Treatment:

      The subject's eligibility (inclusion/exclusion criteria) will be assessed, and all subjects
      will check the FACE-Q Appraisal of Neck scale score

      Treatment:

      The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with
      200~260 lines of 3.0 and 4.5 probe respectively on the subject's neck.

      Post-Treatment:

      All subjects will visit the Institution at 12 weeks from the day of procedure, and will take
      photos of the neck. Efficacy evaluation will performed by the Photographic Evaluator.
    

Intervention name(s): Ultherapy™ System
Intervention type(s): Device
Intervention description(s): The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 200~260 lines of 3.0 and 4.5 probe respectively on the subject's neck.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rhytids; Skin Laxity
Fetal Pillow Randomized Controlled Trial
Condition: Labor Complication
MeSH terms: Obstetric Labor Complications
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate outcomes following cesarean delivery for failure to
      progress with the use of the Fetal Pillow. Our hypothesis is that time to delivery of the
      fetus is shorter with implementation of the Fetal Pillow.
    

Detailed description: 
      Women will be enrolled from the labor floor during their labor course when there is concern
      for cesarean section for failure to progress in the second stage of labor. These women may be
      approached if they have a prolonged labor course (before they reach full dilation), when they
      get to full dilation and start pushing, or following an unsuccessful operative delivery. All
      women who meet the inclusion criteria will be approached about participation in the study on
      labor and delivery. The process of informed consent will happen at that time on labor and
      delivery. All women will be enrolled by study staff or certain physicians at Brigham and
      Women's Hospital who have agreed to help consent patients for this study.

      Once consent is obtained, the subjects will then be randomized 1:1 into two parallel groups,
      the Fetal Pillow Inflated (FPI) group and the Fetal Pillow Not Inflated (FPNI) group. A
      random number generator will allocate the groups in blocks of ten.

      The Fetal Pillows used in the study have been donated by Safe Obstetrics Systems.

      Each patient will have a Fetal Pillow inserted vaginally by the obstetrician after
      catheterization of the bladder (if it has not been previously performed). Once the Fetal
      Pillow is in place, the woman's legs will be placed flat on the operating table. The
      anesthesiologist will then inflate the Fetal Pillow if the patient has been randomized into
      the Fetal Pillow Inflated (FPI) group. In the Fetal Pillow Not Inflated (FPNI) group, the
      device will remain, not inflated, in the vagina. The obstetrician will therefore be blinded
      to the intervention. In the FPNI group the obstetrician will continue to be able to use
      conventional methods for delivery of a second stage arrest including hand from below and
      reverse breech extraction. The Fetal Pillow will be drained by the circulating nurse in the
      operating room following delivery with removal at the end of the procedure by the
      obstetrician.
    

Intervention name(s): Fetal Pillow
Intervention type(s): Device
Intervention description(s): see arm description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Maternal outcomes; Neonatal Outcomes
Head Elevation During Pre-oxygenation Can Delay Desaturation Time
Condition: Surgery; Desaturation of Blood; Apnea
Study type: Interventional

Summary: 
      This study is a randomized-controlled trial study comparing the association between several
      degree of head elevation and conventional position during pre-oxygenation to desaturation
      time in patients undergo endotracheal intubation with general anesthesia
    

Detailed description: 
      Preoxygenation anesthesia induction is an important part of airway management to reduce the
      risk of hypoxemia when the patient is apneic. The effectivity of preoxygenation is influenced
      by several things such as patient's head position. This study aimed to compare preoxygenation
      with head elevation 20°, 30° and 45° and conventional position to the time of desaturation
      before endotracheal intubation in patients undergoing general anesthesia. This was a
      randomized clinical trial of 56 patients, divided into four groups (conventional or 0° head
      elevation group, 20° head elevation group, 30° head elevation and 45° head elevation group).
      All subject was preoxygenated for 3 minutes with 100% oxygen. Induction of anesthesia was
      started with fentanyl, propofol, followed by rocuronium after the patient lost consciousness.
      Time was recorded from the start of induction until the oxygen saturation showed 93% or a
      time limit of 5 minutes. There was a significant difference in mean desaturation time among
      the four groups (p = 0.011). The most significant different was in 45o head elevation group
      (p < 0.05). . In patients undergoing general anesthesia, pre-oxygenation with head elevation
      20°, 30° and 45° slows down the time for desaturation before endotracheal intubation compared
      to the conventional position. The 45° head elevation has the best result.
    

Intervention name(s): Supine position; 20 degree head elevation position; 30 degree head elevation position; 45 degree head elevation position
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Patients preoxygenated in supine position before endotracheal intubation; Patients preoxygenated in 20 degree head elevation position before endotracheal intubation; Patients preoxygenated in 30 degree head elevation position before endotracheal intubation; Patients preoxygenated in 45 degree head elevation position before endotracheal intubation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were divided into 4 groups by random sampling each with different intervention
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: preoxygenation; head elevation; desaturation; apnea
Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, double blind, placebo controlled, 2 arm, parallel group,
      methodology study to assess the effect of 6 weeks of liraglutide administration on food
      intake in obese subjects.
    


Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Liraglutide; Placebo
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Helicobacter Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine,
      compared with placebo.
    


Intervention name(s): H.pylori vaccines; Placebo Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose of H.pylori vaccine at 0, 1, and 2 months; Placebo Vaccine at 0, 1, and 2 months
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: helicobacter pylori infection; vaccination; adults
Study of FG-4592 in Subjects With Chronic Kidney Disease in China
Condition: Anemia in Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the
      correction of anemia in non-dialysis chronic kidney disease patients.
    

Detailed description: 
      Dose ranging study with two consecutive dose escalation cohorts. The study objective is to
      demonstrate that FG-4592 is effective in the correction of anemia in chronic kidney disease
      patients.
    

Intervention name(s): FG-4592; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TIW dosing, capsule; TIW dosing, capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anemia; Renal