bioihbjkbjnl/mcl2 huggingface dataset:
Medically Reproducing Bariatric Surgery
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Type 2 diabetes (DM2) is a chronic disease affecting 29 million Americans and a leading cause
      of blindness, kidney failure, and limb loss (Engelgau et al 2004). Roux-en-Y gastric bypass
      (RYGB) is the only intervention that leads to durable DM2 remission ~ 80% of the time
      (Mingrone et al 2012). Yet, it's broad application is limited by cost, invasiveness, and
      clinical inertia. Medically reproducing RYGB would extend the benefit of disease remission to
      the vast majority of DM2 patients using a cheaper, less invasive and more palatable treatment
      approach. Although all of the mechanisms mediating DM2 remission are not known, it is widely
      accepted that RYGB induces caloric restriction and enhances meal-stimulated release of a
      gut-peptide called glucagon-like-peptide-1 (GLP-1) both of which improve glycemic control in
      type 2 diabetes (Dar et al 2012; Jackness 2013). Caloric restriction can be achieved using
      OPTIFAST which is a commercially available medical weight loss program that has demonstrated
      the ability to decrease weight and improve glycemic control (Kirschner et al; 1998). Enhanced
      meal-stimulated GLP-1 release can be achieved using Liraglutide an FDA-approved once daily
      GLP-1 analogue that improves glycemic control and induces weight loss.

      The investigators hypothesize that adding OPTIFAST (caloric restriction) in suboptimally
      controlled DM2 patients on Liraglutide (enhanced meal stimulated GLP-1 release), Metformin
      and Lantus insulin will medically reproduce RYGB and lead to DM2 remission, weight loss,
      decreased medication intensity and improved health related quality of life.
    

Detailed description: 
      This is a 24 week "proof of concept" study that will examine if adding "caloric restriction"
      (OPTIFAST) to "enhanced GLP-1 release" (Liraglutide) will lead to discontinuation of Lantus
      and Metformin. The primary outcome measure is change in glycemic control measured as
      hemoglobin A1C. Secondary outcome measures are change in weight, medication intensity and
      health related quality of life.
    

Intervention name(s): OPTIFAST
Intervention type(s): Other
Intervention description(s): OPTIFAST meal replacement includes shakes, bars and soups. These meal replacements will completely replace the subject's diet for the first 12 weeks of the study (baseline-week 12) followed by a gradual transition back to prepared meals over 6 weeks (week 13-18). Attempt will be made to reduce or eliminate Lantus and Metformin as long as glycemic control is maintained.
Intervention model: Single Group Assignment
Intervention model description: "Proof of concept" study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Roux-en-y gastric bypass; GLP-1; Liraglutide; OPTIFAST
Medium-Term Follow-Up of Alpha-D Cervical Disk Prosthesis
Condition: Cervical Disc Disease
Study type: Observational

Summary: 
      Prostheses use subsequently became prevalent and a number of studies were conducted. However,
      prosthesis-associated heterotropic ossification (HO) in the segments with prostheses was
      reported in 2005, which disrupted mobility and caused fusion.

      In the present study, we aimed to investigate the clinical outcomes, HO incidence, and
      prosthesis mobility in the patients following the operative use of Alpha-D disc prosthesis as
      developed and used by the authors to treat cervical disk diseases.
    


Intervention name(s): Alpha-D CDP
Intervention type(s): Device
Intervention description(s): Alpha-D cervical disc prosthesis was developed jointly by the Spine Center of Koç University Faculty of Medicine and Toledo University Bioengineering Department. It was designed as a single unit to ensure user-friendly administration for surgeons, and it was designed and manufactured to reproduce the movements of the normal cervical movement segment.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We included 33 patients with cervical disc hernia and associated radiculopathy upon
        radiological examination, who underwent a cervical discectomy and received cervical disc
        protheses (CDP; arthroplasty) with a single-level anterior discectomy.
Neurotensin Infusions in Healthy Individuals -
Condition: Healthy
Study type: Interventional

Summary: 
      Neurotensin (NT) is a gut peptide released postprandially from the small intestine. It is
      known to exert a range of enterogastrone effects and in animal models it reduces food intake
      when administered by parenteral routes.

      In this study, after a 1h baseline period, three doses (2.5, 5.0 and 7.5pmol/kg/min) of NT
      will be administered in sequence each infusion lasting 1h. On a placebo day saline will be
      infused similarly 1h infusions. During the final infusion (7.5pmol/kg/min) an ad libitum meal
      will be ingested. During the experiments blood samples will be collected and subjective
      perceptions recorded using validated visual analogue scales.
    


Intervention name(s): Neurotensin; Saline
Intervention type(s): Other; Other
Intervention description(s): Neurotensin is an endogenous peptide released from the distal small intestine. It will be administered at three doses (2.5, 5.0 and 7.5pmol/kg/min), each for 1h, in sequence.; Isotonic saline will serve as a placebo.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Acute physiological experiments conducted in healthy individuals in a University Hospital setting.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Appetite regulation; Food intake; Ad libitum; Hormone secretion
Study Of White Blood Cells In The Cerebrospinal Fluid And Blood Of Patients With Relapsing Forms Of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to count the number of white blood cells in the cerebrospinal fluid and blood
      at the beginning and end of treatment with firategrast and at 4 and 12 weeks after stopping
      firategrast. Cerebrospinal fluid flows through and protects the brain and spinal cord. It is
      important to understand what happens to the number of white blood cells because they are
      important in preventing infections.
    


Intervention name(s): firategrast
Intervention type(s): Drug
Intervention description(s): 900 (females) or 1200 (males) mg twice daily for 24 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: firategrast; lymphocytes; leukocytes; SB-683699; cerebrospinal fluid; relapsing forms of multiple sclerosis
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type
Condition: Agitation in Participants With Dementia of the Alzheimer's Type
MeSH terms: Dementia; Alzheimer Disease; Psychomotor Agitation
Study type: Interventional
Phase: Phase 3

Summary: 
      Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of
      probable Alzheimer's disease (AD) will be based on the "2011 Diagnostic Guidelines for
      Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association
      (AA) workgroups.
    

Detailed description: 
      Eligible participants for this study must have a diagnosis of probable AD and must have
      clinically meaningful agitation secondary to AD.

      This is a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of
      treatment.

      Approximately 470 participants will be enrolled at approximately 75 centers in North America.

      Study medication will be administered orally twice-daily from Day 1 through Week 12 (Day 85).
      Screening will occur within approximately 4 weeks prior to randomization. Following screening
      procedures for assessment of inclusion and exclusion criteria, eligible participants will be
      randomized into the study.
    

Intervention name(s): AVP-786-18; Placebo; AVP-786-28; AVP-786-42.63
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 18 mg of Deudextromethorphan hydrobromide (d6-DM) and 4.9 mg of Quinidine sulfate (Q); Administered as capsules.; 28 mg of d6-DM and 4.9 mg of Q; 42.63 mg of d6-DM and 4.9 mg of Q
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Muscle Thickness and Balance in Young and Older Adults
Condition: Healthy; Balance; Distorted
Study type: Interventional

Summary: 
      This study evaluates muscle thickness of trunk and lower limb and balance in young and older
      healthy adults. The participants will be evaluated muscle thickness for 14 different muscle
      and balance which evaluated by computerized force plate system.
    

Detailed description: 
      Aging had an adverse affect on musculoskeletal system and balance parameters. Decreased
      muscle strength or thickness negatively affect person's balance control. But there are no
      information in the literature about the relationships between muscle thickness and balance in
      healthy subjects. In addition to, it is not known which muscle responsible for balance.
      Therefore, this study will evaluate muscle thickness via ultrasonography and balance in young
      and older adults. Balance will be evaluated computerized Balance system. Muscle thickness for
      different 14 muscle ( diaphragm, transversus abdominis,multifidus, longissimus, quadratus
      lumborum, rectus abdominis, external and internal obliques, rectus femoris, vastus
      intermedius, vastus lateralis, tibialis anterior, gastrocnemius, soleus) will be evaluated by
      ultrasonography at the right side. Only diaphram muscle will be evaluated both right and left
      side.
    

Intervention name(s): Balance Analysis
Intervention type(s): Other
Intervention description(s): Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Balance; Postural control; Muscle; Older adults
High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. The use of folic acid may be an effective way to prevent
      colorectal cancer in patients with polyps that have been surgically removed.

      PURPOSE: Randomized phase II trial to study the effectiveness of high-dose folic acid in
      preventing colorectal cancer in patients who have had polyps surgically removed within 18
      months of the trial.
    

Detailed description: 
      OBJECTIVES: I. Determine whether high-dose folic acid decreases global DNA hypomethylation,
      as well as other intermediary markers, in normal-appearing colonic epithelium of patients
      with colonic adenomas. II. Determine whether a decrease in global DNA hypomethylation and
      other intermediary markers can be induced safely and whether these effects persist after
      folic acid is discontinued in these patients. III. Confirm pilot data that indicates patients
      with adenomas have widespread DNA hypomethylation of the colorectal mucosa compared to
      controls. IV. Evaluate the effect of folic acid on the clinical course and rate of recurrence
      of adenomatous polyps in these patients. V. Study a control group of patients with no history
      of neoplastic, hyperplastic, or inflammatory colorectal lesions.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to participating center and age (50-70 vs 30-49 and over 70).
      Patients with adenomatous polyps at least 10 mm at colonoscopy are randomized to 1 of 2
      treatment arms. Patients found to have no neoplastic, hyperplastic, or inflammatory polyps at
      colonoscopy are assigned to a control (untreated) group and complete laboratory studies and a
      baseline food frequency questionnaire only. Arm I: Patients receive folic acid daily. Arm II:
      Patients receive placebo daily. Treatment continues in both arms for 1 year in the absence of
      unacceptable toxicity or disease progression. Patients are followed at 1 year.

      PROJECTED ACCRUAL: A total of 80 patients (30 per arm and 20 for the control group) will be
      accrued for this study within 24 months.
    

Intervention name(s): folic acid
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Primary purpose: Prevention
Keywords: colon cancer; rectal cancer
How Different Beta-2 Receptor Genotypes Affect an Asthmatic's Response to Regular Salmeterol Treatment
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of the study is to find out how well a long-acting beta agonist like salmeterol
      works in people with different forms of the same gene. Our hypothesis is that asthmatics with
      the Arg/Arg genotype will have loss of bronchoprotection against exercise-induced asthma with
      regular salmeterol treatment, as compared to asthmatics with the Gly/Gly genotype.
    

Detailed description: 
      In many patients with asthma, exercise-induced bronchoconstriction is a common and oftentimes
      limiting characteristic. Inhaled β2-adrenoreceptor agonists like albuterol are the most
      effective treatments available for the relief of acute asthma symptoms. However, there is
      evidence that regular use may lead to adverse effects in some patients. Previous studies have
      shown that polymorphisms of the β2-adrenergic receptor can influence airway responses to
      regular inhaled beta-agonist treatment.

      Pharmacogenetics is the study of how genetic differences influence the variability in
      patients' responses to therapy, both therapeutic and adverse. Genetic susceptibility and
      environmental factors both play major roles in the etiology of asthma. The strong familial
      clustering of asthma has lead to a surge of research into the genetic predisposition of
      asthma. The aim of the present study is to utilize a double-blinded prospective cohort study
      to investigate whether genotype-specific effects occur when assessing the duration of
      protection conferred against exercise-induced bronchoconstriction by regular salmeterol
      treatment.
    

Intervention name(s): salmeterol
Intervention type(s): Drug
Intervention description(s): salmeterol 50 micrograms twice daily for 2 weeks
Intervention MeSH terms: Salmeterol Xinafoate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; exercise induced asthma; exercise induced bronchoconstriction; long acting beta agonist; salmeterol; exercise challenge; bronchoprotection; beta 2 adrenergic receptor polymorphisms; pharmacogenetics
Comparison of Operated Ruptured and Non-ruptured Endometriomas
Condition: Endometrioma; Ruptured Endometrioma; Endometriosis Ovary
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      Ruptured endometrioma cases were compared with unruptured endometrioma cases.
    

Detailed description: 
      This study aims to compare the findings in patients who had surgery for ruptured endometrioma
      with the patients who had an unruptured endometrioma.

      This study was conducted at Republic of Turkey Ministry of Health, Health Science University
      Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic and all
      patients who were operated for endometrioma and had a histopathology report confirming the
      presence of endometrioma between January 2014 and December 2020 were included.

      In this study, demographic characteristics, intraoperative findings, laboratory values and
      follow-up recommendations of two groups compared. The patients' age, presence of sexual
      activity and/or infertility, gravidity, parity, abortion, history of ectopic pregnancy,
      accompanying systemic disease, previous operations, drug use, and symptoms were recorded.
      Preoperative and postoperative complete blood count, Cancer antigen 125 (CA 125), Cancer
      antigen 19-9 (CA19-9), Cancer antigen 15-3 (CA 15-3), Carcinoembryonic antigen (CEA), alpha
      fetoprotein (AFP), anti mullerian hormone (AMH), fibrinogen, C-reactive protein (CRP) values
      of the patients were obtained. Patient files, operation notes and laboratory values of the
      electronic recording system database and the two groups were compared.
    

Intervention name(s): Laparoscopy/Laparotomy
Intervention type(s): Procedure
Intervention description(s): All patients included in the study were operated patients.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who were operated on in Republic of Turkey Ministry of Health, Health Science
        University Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility
        Clinic, whose histopathological diagnosis was confirmed as endometrioma. All patients were
        women of reproductive age with a pelvic mass.
      
Biospecimen description: 
      all patients who were operated for endometrioma and had a histopathology report confirming
      the presence of endometrioma Surgical materials were biospecimens, which had a histopathology
      report confirming the presence of endometrioma
    
Keywords: endometrioma; rupture; endometriosis
A Study Comparing the Effects of Trimbow to Fostair in COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomised, open label 2-way cross-over study to compare the effects of inhaled
      Beclometasone/Formoterol/Glycopyrronium (TRIMBOW) pMDI to Beclometasone/Formoterol (FOSTAIR)
      pMDI on hyperinflation and expiratory flow limitation in moderate to severe chronic
      obstructive pulmonary disease (COPD).
    

Detailed description: 
      This study will investigate the contributions of extra-fine glycopyrronium and formoterol
      (within triple therapy) to improvements in small airway function in COPD patients. This will
      be achieved by recruiting patients with hyperinflation, and measuring improvements in
      hyperinflation and expiratory flow limitation as measurements of small airway disease.

      This study will help understand the mechanisms of action of the bronchodilators within
      BDP/FF/GB, and potentially encourage treatment of small airway disease in COPD with
      extra-fine bronchodilator treatments. This trial will be conducted in compliance with the
      Declaration of Helsinki (1964 and amendments) current Good Clinical Practices and all other
      applicable laws and regulations.
    

Intervention name(s): Trimbow pMDI; Fostair pMDI
Intervention type(s): Drug; Drug
Intervention description(s): Clinical Trial of an Investigational Medicinal Product (CTIMP); Clinical Trial of an Investigational Medicinal Product (CTIMP)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a phase IV, open-label, randomised, single centre, 2-way crossover study.
Masking: None (Open Label)
Primary purpose: Treatment
Cold Induced Activation of Brown Adipose Tissue in Humans
Condition: Adipose Tissue, Brown; Brown Adipose Tissue; Brown Fat; Uncoupling Protein 1; Adipokines; Proteomics; Infrared Thermography; BAT; Obesity; Type 2 Diabetes; Proteins
Study type: Interventional

Summary: 
      This study investigates cold-induced brown fat activation assessed using PET/MR scans.
      Subjects will participate in an acute cooling intervention day and a thermoneutral
      intervention day with PET/MR scans on both days. A secondary purpose is to make a validation
      of an infrared thermography camera by comparison of skin temperatures and SUV of the
      supraclavicular brown adipose tissue.
    

Detailed description: 
      The field of human brown adipose tissue (BAT) research is focused on activation of BAT as a
      means of manipulating energy expenditure and potentially anti-obesity and anti-diabetic
      properties of the tissue. This is well established in rodent studies and explained as due to
      the specific brown fat uncoupling protein 1 (UCP1). Despite increasing evidence that
      indicates a metabolic regulatory role of BAT in humans, BAT activation/recruitment is not
      fully understood and even less is known about the endocrine capacities of human BAT.

      Cold induced brown fat activity will be assessed with PET/MR scans and validate an infra-red
      thermography camera, as well as perform a proteomic screening using blood samples under these
      two intervention days.

      15 healthy lean male subjects will serve as their own control in a cross-over randomized
      control study, including a pre-examination day, a thermoneutral-day and a cooling test-day
      with cold exposure followed by a PET/MR scan to determine BAT activity. An extra cooling day
      is applied for the external validation of the infrared thermography camera. Blood samples and
      abdominal fat-biopsies will be taken at thermoneutral condition and under cold stimulation of
      brown fat.
    

Intervention name(s): Cooling; Thermoneutral
Intervention type(s): Procedure; Procedure
Intervention description(s): Individualized cooling protocol.; Thermoneutral control day.
Other intervention name(s): Cold activation; Cold stimulation; Cold activation of BAT
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science