bioihbjkbjnl/mcl2 huggingface dataset:
Quantitative 18F-AV-133 PET Imaging in Subjects With Diabetes and Healthy Controls
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate 18F-AV-133 imaging of the pancreas in patients with early type 2 diabetes, late
      type 2 diabetes, subjects with pre-diabetes and in healthy overweight/obese control subjects.
      These subjects will also be evaluated for beta-cell function as measured by the insulin and
      C-peptide response to a challenge with intravenous arginine under basal and glucose enhanced
      conditions.
    


Intervention name(s): 18F-AV-133; 10% Arginine Hydrochloride-R-Gene 10
Intervention type(s): Drug; Drug
Intervention description(s): 296 MBq (8 mCi)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Pilot Study: VR Mind and VR Mind+ Intervention
Condition: Social Phobia
MeSH terms: Phobia, Social
Study type: Interventional

Summary: 
      The aim of the pilot study is feasibility, usability and safety assessment of VR Mind
      intervention. In particular the subject of assessment will be:

        -  the length of the laboratory session utilizing virtual reality exposure (feasibility),

        -  the ergonomics and ease of use for both patients and system operators (usability),

        -  the frequency of side effect occurrence as a result of virtual reality exposure (ie.
           Vertigo) (safety).

      The results pilot study will be used in the designing a clinical trial aimed for testing
      efficacy and safety of VR Mind intervention.
    

Detailed description: 
      In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named
      VR Mind. The software utilizes the concept of virtual reality exposure therapy to treat
      social anxiety disorder. The pilot investigators will be tested for the feasibility,
      usability and safety of the system in order to obtain information useful in further designs
      for the clinical trial. The research consists of four laboratory sessions. The first and the
      last session will be dedicated to participant assessment. During the second and third session
      the virtual reality scenarios (2 x 10 minutes for each session) will be presented to
      participants. The participants will be playing a role of someone who is giving a speech
      (Public speaking scenario) and someone who is speaking on a phone in public (Telephoning in
      public scenario).
    

Intervention name(s): VR Mind
Intervention type(s): Behavioral
Intervention description(s): Two VR Mind sessions using virtual reality scenarios concerning social situations in which social phobics are prone to experience anxiety. The pilot study will consist of two scenarios: "Public Speaking in Lecture Hall" and "Telephoning in Public". Two sessions are planned, each containing two expositions to virtual reality environment, each lasting 10 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: vr; virtual reality; social phobia; vret; virtual reality exposure therapy
Vaginal Film Administration and Placement Study: FLAG
Condition: Healthy Women
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate use of four different vaginal films - two sizes and
      two textures. The vaginal films have no active ingredients or medications. Information will
      be gathered about each film (i.e. ease of insertion, proper placement, opinions about each).
      The results of this study will help investigators determine which type of vaginal film to use
      (and how to write product instructions) for future studies.
    

Detailed description: 
      All women will use all 4 products in a randomized study design with a crossover evaluation
      during 10 visits over two months. Visits will be scheduled when the participant is not
      menstruating/bleeding. The sequence of film use will be randomized. Study procedures will
      involve a screening visit (VISIT 1) during which a baseline cervicovaginal lavage will be
      collected and infections will be excluded. After randomization (VISIT 2) women will be given
      instructions and instructed to insert the first film. An external genital examination will be
      performed after the participant inserts the film to verify film placement. In the event a
      participant has difficulty placing the film, the study clinician may place the film for them.
      Following each film insertion, a questionnaire will be administered to obtain feedback
      regarding ease of administration. Thirty minutes after product insertion a clinician will
      visualize film placement in the vagina by speculum examination. Women will be counseled to
      avoid sexual activity or vaginal product usage before VISIT 3 scheduled for the following
      day. At visit 3 women will have a speculum examination to assess whether the film has
      completed disintegrated and a CVL sample will be collected. Women will be given an
      appointment for the next film insertion in 7-20 days. The general sequence of events will be
      repeated for each subsequent film. At the next visit (VISIT 4) women will insert the second
      film and have the same evaluation as visit 2. A CVL sample will be collected 24 hours later
      (VISIT 5). Women will be asked to return to insert another film 7-20 days later (VISIT 6) and
      a CVL sample will be collected the next day (VISIT 7). Women will receive the final film 7-20
      days later (VISIT 8) and have the final CVL collection following film insertion the next day
      (VISIT 9). A final visit (VISIT 10) will be scheduled >14 days after visit 9. During this
      visit a CVL will be collected for glycomic and innate antiviral activity studies and an in
      depth interview will be conducted in order to gain insights into the role of film polymer and
      size on perceived ease of insertion across the four film types.
    

Intervention name(s): Placebo Film
Intervention type(s): Other
Intervention description(s): placebo vaginal films
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Oral Lactoferrin Versus Iron Supplementation During Pregnancy
Condition: Iron-deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional
Phase: Phase 4

Summary: 
      Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron.
      The oral route is preferred to the parenteral route to replace iron stores [Sharma JB; et
      al., 2004]. Inorganic iron has poor bio-availability in addition to many side effects,
      including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may
      sometimes increase susceptibility to infection [ So¨lvell L; et al., 1970].
    

Detailed description: 
      Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron.
      The oral route is preferred to the parenteral route to replace iron stores. This allows the
      normal mechanism of absorption to be used, in addition to being an inexpensive and effective
      treatment [Sharma JB; et al., 2004]. Inorganic iron has poor bio-availability in addition to
      many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and
      constipation and it may sometimes increase susceptibility to infection [ So¨lvell L; et al.,
      1970].

      Furthermore, routine iron supplementation has recently been challenged. The British Society
      for Hematology, Obstetric Hematology Group (BSH OHG) and the British Committee for Standards
      in Hematology (BCSH) recommend screening by Full blood count (FBC) at booking and at 28 weeks
      instead of universal iron supplementation [Pavord S. 2012]. Lactoferrin is a high-affinity
      cationic iron binding glycoprotein [Baker EN, 2005]. Bovine Lactoferrin is currently
      available pharmaceutical preparation. It is in to safe and effective in treating pregnant
      women suffering from ID and IDA [Mohamed Rezk, et al. 2015]. This study will compare the
      efficacy of these three available options.
    

Intervention name(s): Lactoferrin; Iron Supplement; Chelates, Iron
Intervention type(s): Drug; Drug; Drug
Intervention description(s): parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia; Iron Sulphate 150 mg once daily; Amino acid chelated iron capsules contain 15 mg
Other intervention name(s): Iron Sulphate; Amino acid chelated iron
Intervention MeSH terms: Iron; Lactoferrin; Iron Chelating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 groups of pregnant women will be assigned for each intervention
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Iron; Deficiency
Pre-dinner vs. Post-dinner Exercise on Glycemic Control
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      With many medications we prescribe them relative to time of day or a meal. This study
      established if pre dinner vs post dinner exercise was more effective at altering post dinner
      glucose and triglyceride levels vs no exercise at all.
    

Detailed description: 
      All participants completed three trials in a random order in which they consumed a
      standardized dinner meal with 1) no RE (NoRE), 2) pre-dinner RE (RE→M), and 3) post-dinner RE
      beginning 45 min after dinner (M→RE). Diet was standardized during the day of testing.
      Participants reported to the lab for testing sometime between 3 - 5:30 p.m. and upon arrival
      a venous catheter was inserted into a forearm vein. Frequent blood sampling, indirect
      calorimetry measurements, and subjective well-being measurements ensued for ~5.75 h while the
      participants were in the lab.
    

Intervention name(s): No exercise; Meal then exercise; exercise then meal
Intervention type(s): Other; Other; Other
Intervention description(s): During the no exercise trial (NoEX), the participants will remain sedentary during testing.; During the post-meal exercise trial (M→EX), 45 min of resistance training will be performed; During the exercise prior to the meal trial (EX→M), 45 min of resistance training will be performed
Other intervention name(s): NoEX; M-EX; EX-M
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: GIP; GLP-1; exercise timing; resistance exercise; glucose concentrations
Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?
Condition: Epilepsy; Psychiatric or Mood Diseases or Conditions
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      Women who take folate (folic acid) before getting pregnant can lower the risk of giving birth
      to infant with certain birth defects. However, some medications may affect the action of
      folate. The purpose of this study is to compare the effect of two anti-epileptic drugs on how
      folate works in our body.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention. This is a cross-sectional study.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients in epilepsy and/or psychiatric clinics
      
Keywords: Folate Receptor Autoantibodies; Epilepsy; Psychiatric conditions
Laser Therapy on Hamstring Muscle Among Young Adults
Condition: Muscle Tightness
Study type: Interventional

Summary: 
      A total of 154 healthy young individuals will be recruited by purposive sampling method to
      participate in a randomized, single-blinded, sham-controlled study. Recruited participants
      will be randomly dividing into two groups, the Active high-intensity laser therapy (a-HILT)
      group, and the Sham high-intensity laser therapy (s-HILT) group. The treatment duration will
      be 10 minutes per session on both lower limbs for each day for 3 days/week for 2 weeks.
      Hamstring muscle length will be assessed at baseline, end of the 2-week post-intervention
      period.
    


Intervention name(s): Active High-intensity laser therapy; Sham High-intensity laser therapy
Intervention type(s): Device; Device
Intervention description(s): High-intensity laser therapy will be used in the contact method, with the laser beam irradiated over the hamstring muscle. Dosage and parameters for the laser will be calculated.
Parameters-
Wavelength- 980 nm
Intensity/Power density- 3W/cm2
Emission mode- Continuous Emission
Energy (Joules)- 490 J
Irradiation time- 70 Sec on each point
Peak power- 15 Watt
Irradiation points- 09; Sham High-intensity laser therapy will be used in the contact method, without the laser beam irradiation over the hamstring muscle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Flexibility; Hamstring; Laser therapy; Young adults
National Tunisian Registry of Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational [Patient Registry]

Summary: 
      The Tunisian Society of Cardiology and Cardiovascular Surgery (STCCCV) proposes to coordinate
      a national, observational, cross-sectional and multicenter survey carried out during one
      month. The main objective of the survey is to describe the blood pressure and cardiovascular
      risk profile of the hypertensive patient in Tunisia.

      This survey will allow us to have a generalized and updated view of the tunisian hypertensive
      patient in order to optimize treatment and to know the degree of adherence of practitioners
      to international recommendations in the care of the hypertension in Tunisia.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All patients presenting in consultation of cardiology, general medicine / family medicine,
        internal medicine and nephrology will be recruited in the survey.
      
Keywords: NATURE-HTN
Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5)
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This "first-in-human" exploratory IND, single-center study will assess the safety, toxicity,
      hematology, and immunogenicity of sub-therapeutic "microdoses" of autologous Thrombosomes® in
      healthy human subjects.
    


Intervention name(s): Thrombosomes; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Freeze-dried platelets
Other intervention name(s): Buffer/placebo Control
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study of the Effects of Pirtobrutinib (LOXO-305) on Repaglinide (CYP2C8 Substrate) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of pirtobrutinib (LOXO-305) on
      single oral dose of repaglinide (CYP2C8 substrate) when administered as multiple doses by
      conducting the blood tests to measure how much pirtobrutinib (LOXO-305) is in the bloodstream
      and how the body handles and eliminates pirtobrutinib (LOXO-305) in adult healthy
      participants. The study will also evaluate the safety and tolerability of pirtobrutinib
      (LOXO-305). The study is conducted in two periods. Participants will stay in this study for
      up to 54 days.
    


Intervention name(s): Repaglinide; Pirtobrutinib
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Other intervention name(s): LOXO-305; LY3527727
Intervention MeSH terms: Repaglinide; Pirtobrutinib
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Left Ventricular Lead Position in Cardiac Resynchronization Therapy
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      Left ventricular (LV) lead position has crucial impact on cardiac resynchronization therapy
      (CRT) success. This study will compare fluoroscopy and myocardial deformation imaging for
      optimal definition of LV lead position.
    

Detailed description: 
      In a 16 segment model circumferential strain will be used to determine the segment with
      latest peak systolic circumferential strain prior to CRT, considered as the optimal LV lead
      target. LV lead will be defined by (1) fluoroscopy, (2) the maximal temporal difference of
      peak circumferential strain before-to-on CRT and (3) the earliest peak systolic
      circumferential strain during LV pacing. For all 3 modalities optimal LV lead position is
      defined as concordance or immediate neighbouring of the segment with defined LV lead position
      to the determined optimal target segment. At follow-up echocardiography will be performed to
      determine improvement in LV function and remodeling.
    

Intervention name(s): Implantation of a cardiac resynchronization therapy device; Echocardiography (myocardial deformation imaging)
Intervention type(s): Procedure; Procedure
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients with end-stage heart failure and sinus rhythm, scheduled for new
        implantation of a biventricular pacemaker were included in the study. Criteria for CRT
        implantation were New York Heart Association (NYHA) functional class III (N=35) or IV
        (N=21) despite optimal pharmacologic therapy and evidence of LV systolic dysfunction with
        ejection fraction <35% and a QRS >120ms.
      
Keywords: cardiac resynchronization therapy; echocardiography; heart failure; left ventricular function; pacing; myocardial deformation imaging; Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy
A Double-blinded,Double-dummy Clinical Trial of Chinese Herbal Medicine (MaZiRenWan) for Functional Constipation
Condition: Functional Constipation; Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the efficacy and safety of a Chinese herbal
      proprietary medicine, MaZiRenWan (MZRW), by comparing with stimulant laxative western
      medicine (WM), senna, and placebo for patients with functional constipation (FC) in excessive
      TCM syndrome.
    

Detailed description: 
      Functional constipation (FC) is a common clinical complaint. Despite the effectiveness of
      MaZiRenWan (MZRW) for alleviating FC symptoms has been proofed in the previous study.Given
      the results of the dose determination study and placebo-controlled study of MZRW, we
      hypothesize that MZRW is more useful than senna (senokot), a commonly used WM drug for
      constipation, for FC patients in excessive TCM syndrome.This is a prospective, double-blind,
      double dummy, randomized, controlled trial. After a 2-week run-in, eligible FC patients (Rome
      III) in excessive TCM syndrome will randomly be assigned to CHM arm (MZRW and WM placebo), WM
      arm (senna and CHM placebo) or placebo arm (CHM placebo and WM placebo). Patients will
      undergo an 8-week treatment and an 8-week follow-up.
    

Intervention name(s): MZRW; Senna; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients are instructed to dissolve a sachet of granules (7.5g) in 150ml of hot water; they take this solution orally twice daily for 8 weeks.; Patients are instructed to take 2 tablets at the bedtime for 8 weeks.; The placebo MZRW is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%) and caramel (0.34%) to achieve color, smell, taste and texture comparable to MZRW granules.The placebo Senna is made of starch and colour to achieve comparable appearance to Senokot.
Other intervention name(s): Hemp Seed Pill; Senokot
Intervention MeSH terms: Sennosides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized controlled trial; Drugs,Chinese Herbal; Constipation/drug therapy
Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets
Condition: Congenital Adrenal Hyperplasia
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Hyperplasia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will test the ability of extended release nifedipine (Procardia XL), a blood
      pressure medication, to permit a decrease in the dose of glucocorticoid medication children
      take to treat congenital adrenal hyperplasia (CAH).
    

Detailed description: 
      This protocol is designed to assess both acute and chronic effects of the calcium channel
      antagonist, nifedipine, on the hypothalamic-pituitary-adrenal axis in patients with
      congenital adrenal hyperplasia. The multicenter trial is composed of two phases and will
      involve a double-blind, placebo-controlled parallel design. The goal of Phase I is to examine
      the ability of nifedipine vs. placebo to decrease adrenocorticotropic hormone (ACTH) levels,
      as well as to begin to assess the dose-dependency of nifedipine effects. The goal of Phase II
      is to evaluate the long-term effects of nifedipine; that is, can attenuation of ACTH release
      by nifedipine permit a decrease in the dosage of glucocorticoid needed to suppress the HPA
      axis? Such a decrease would, in turn, reduce the deleterious effects of glucocorticoid
      treatment in CAH.
    

Intervention name(s): Nifedipine
Intervention type(s): Drug
Intervention MeSH terms: Nifedipine
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment