bioihbjkbjnl/mcl2 huggingface dataset:
Thiazolidinediones (TZD) Bone Loss and the Effects on Bone Marrow Differentiation and Osteoblast Formation
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      Thiazolidinediones (TZDs) are a commonly used antidiabetic drugs currently used by over a
      million patients in the United States. Recent studies have shown that treatment with TZD may
      increase the risk of bone fractures. The cause of bone loss is not known. We believe that TZD
      may cause increased accumulation of fat in the bone marrow, which may cause decrease bone
      formation and weak bones. .
    

Detailed description: 
      This study aims to determine if TZDs increase the amount of fat and decrease the number of
      bone producing cells in the bone marrow.

      A total of 5 subjects who require surgery for mandible (jaw) fracture and bone graft will be
      recruited. Some patients who will undergo mandible surgery will require a bone graft. In this
      procedure, a small piece of bone from the hip is placed in the mandible. In this study, a
      small amount of bone marrow fluid (5 mL or 1 teaspoon) will be obtained after the bone graft
      is completed. Obtaining the bone marrow will not result in additional pain or health
      problems. The effect of TZD on bone marrow and bone forming cells will be studied. The cells
      obtained during surgery will be grown at Dr Beck's laboratory at Emory University School of
      Medicine.

      A working hypothesis suggests that the increased fracture risk in patients taking TZDs is the
      result of TZDs altering the differentiation capacity of bone marrow stromal cells pushing
      them towards the adipocyte lineage at the cost of osteoblast formation thereby decreasing
      bone formation.

      Study AIM:To determine whether TZD exposure in vitro alters bone formation and the
      differentiation capacity of bone marrow stromal cells by promoting adipocyte lineage
      differentiation and lowering osteoblast formation.
    

Intervention name(s): Stromal Cells Sample
Intervention type(s): Procedure
Intervention description(s): Human Bone Marrow Stromal Cells will be obtained from 5 patients. Stromal cells will be obtained from subjects undergoing bone graft procedure to repair traumatic mandible fractures. Bone graft specimens will be obtained from the ileac crest. This will allow easy access to bone marrow specimen without additional pain or complications. A total of 5 ml of bone marrow will be obtained from each patient.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with 1) traumatic mandibular (jaw) fracture who will undergo bone grafting or 2)
        trauma patients who will undergo intra-medullary rod placement for traumatic limb fractures
        will be considered as potential candidates in the study
      
Biospecimen description: 
      Bone Marrow
    
Keywords: investigate; TZD exposure; in vitro; alters; bone; formation; differentiation; capacity; bone marrow; stromal cells
Risk for Ketonaemia in Type 1 Diabetes Pregnancies With Sensor-augmented Pump Therapy
Condition: Pregnant Women With Type 1 Diabetes
MeSH terms: Pregnancy in Diabetics; Diabetes, Gestational; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The ROKSANA study is an open-label crossover RCT with the aim to evaluate whether
      sensor-augmented pump therapy (SAP) with predictive low glucose suspend technology is
      associated with an increased risk for ketonaemia during type 1 diabetes pregnancies.
    

Detailed description: 
      10 pregnant women with type 1 diabetes will be included . Participants will be randomized 1/1
      between 12-30 weeks of pregnancy to SAP with predictive stop before low during two weeks or
      predictive stop on low. Participants will be cross-over to the other group after two weeks
      (from stop before low to stop on low or vice versa). During the study, participants will be
      asked to measure blood ketones three times per day.
    

Intervention name(s): SAP with stop before low; SAP with stop on low
Intervention type(s): Device; Device
Intervention description(s): cross-over comparison from stop on low to stop before low; cross-over comparison from stop before low to stop on low
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: open-label cross-over RCT
Masking: None (Open Label)
Primary purpose: Other
CSD190202: Study to Assess Elements of Abuse Liability for Two Electronic Nicotine Delivery Systems
Condition: Smoking; Tobacco Smoking; Tobacco Use
Study type: Interventional

Summary: 
      This is a randomized, open-label, crossover study designed to evaluate elements of abuse
      liability (AL) including subjective effects, plasma nicotine uptake, and physiological
      measures during and following ad libitum use of the investigational products (IPs) by healthy
      subjects.
    

Detailed description: 
      The study will recruit smokers of combustible cigarettes.

      Potential subjects will complete a pre-screening interview and a Screening Visit to assess
      their eligibility within 45 days prior to enrollment.

      Starting on Day 1, eligible smokers will be confined at the clinical site for 9 days.
      Subjects will participate in four separate Test Sessions for AL assessment, one for each IP.
      Each Test Session will last for approximately 4 hours during and following IP use. Subjects
      will be randomized to use one IP in each Test Session: Usual Brand (UB) combustible
      cigarettes, nicotine gum, and 2 Electronic Nicotine Delivery Systems (ENDS).

      For approximately a day and a half prior to each respective Test Session, IP will be
      dispensed for ad libitum use for product familiarization.
    

Intervention name(s): Product A; Product B; Product C; Product D
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Usual Brand, filtered combustible cigarette; CSD1902-11, an electronic nicotine delivery system; CSD1902-21, an electronic nicotine delivery system; 4mg Nicotine gum
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Rectal Misoprostol in Women Undergoing Myomectomy for Intraoperative Blood Loss: A Randomized Placebo-controlled Study
Condition: Misoprostol, Blood Loss, Myomectomy
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of efficacy of rectal misoprostol for reduction amount of blood loss in women
      undergoing myomectomy, both open and laparoscopic approach
    

Detailed description: 
      According to development of reproductive technology to assist infertile women, rate of
      myomectomy increases. During this operation, surgeons would deal with hypervascular masses
      with raw surfaces that tend to bleeding. Interventions to diminish bleeding were studied such
      as using misoprostol, vasopressin, transamenic acid along with mechanical intervention such
      as tourniquet and uterine artery ligation. But in Rajavithi hospital, such procedures aren't
      generally used because of fewer cases and also lacks of supporting data. Misoprostol, used in
      gynecologic patients for a long time with a wide safety margin acts at prostaglandin
      receptors of myometrium to stimulate contraction that constricts uterine vessels that lead to
      decreasing amount of bleeding during the operation. This led to the experimental study of
      rectal misoprostol administered at 15 - 30 minutes prior the operation to decrease blood loss
      and also blood transfusion rates. Our study also gather data about adverse effect that
      subject experienced after drug administration.
    

Intervention name(s): Rectal Misoprostol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation; Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation
Other intervention name(s): Cytotec; Besix
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Articaine and Bupivacaine in Impacted Tooth Surgery
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      Articaine is a common local anesthetic used in oral surgery and belongs to the amide group of
      it has fast onset with little side effects. Bupivacaine is preferred in prolonged surgical
      procedures with its long duration of action and residual analgesic effect.

      The aim of this study was to evaluate the anesthetic, analgesic, hemodynamic effects of 4%
      articaine and 0.5% bupivacaine in extraction of impacted mandibular third molar teeth in
      intraoperative and postoperative periods. Hemodynamic parameters, onset of anesthetic action,
      total amount, intraoperative comfort, intraoperative bleeding, duration of postoperative
      anesthesia and analgesia, rescue analgesic use, maximum incisal opening and postoperative
      pain at 6th, 12th, 24th, 48th and 72th hours and 7th day using a visual analogue scale be
      evaluated.
    


Intervention name(s): Impacted tooth surgery
Intervention type(s): Procedure
Intervention description(s): Surgical extraction of İmpacted tooth
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, split-mouth, triple-blinded study was designed.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Screening
Biological Standardization of Secale Cereale Allergen Extract
Condition: Allergy to Grass Pollen (Secale Cereale)
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the biologic activity of a Secale cereale
      allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house
      reference preparation (IHRP).
    

Detailed description: 
      This is an open, unblinded and non-randomized biological assay. The study design is a slight
      modification of the recommendations proposed by the Nordic Guidelines.

      Four concentrations of Secale cereale allergen extract, together with a positive and negative
      control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline
      solution, respectively, will be tested in every patient in duplicate on the volar surface of
      the forearm.
    

Intervention name(s): Four different concentrations of Secale cereale allergen extract, positive control and negative control
Intervention type(s): Biological
Intervention description(s): 4 concentrations of Secale cereale allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Immunotherapy; Skin prick test; Standardization; Secale cereale
STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis (IPF)
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of
      subcutaneously (SC) administered multiple, escalating doses of BG00011 (a humanized
      monoclonal antibody directed against the alpha v beta 6 (αvβ6) integrin, formerly known as
      STX-100) in participants with IPF. The Secondary objectives are to estimate the
      pharmacokinetic (PK) parameters after the 1st dose and after the last dose of multiple,
      escalating doses of BG00011 in participants with IPF, to assess the immunogenicity of BG00011
      in participants with IPF, and to assess the effect of BG00011 on biomarkers isolated from
      bronchoalveolar lavage (BAL) and peripheral blood in participants with IPF.
    

Detailed description: 
      This study was previously posted by Stromedix, Inc. In April, 2014, sponsorship of the trial
      was transferred to Biogen. The study drug name was changed from STX-100 to BG00011 and the
      study number was changed from STX-003 to 203PF201, to align with sponsor conventions.
    

Intervention name(s): BG00011; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BG00011 will be administered at varying doses via subcutaneous (SC) injection; Sterile normal saline (0.9% Sodium Chloride for Injection) via Subcutaneous (SC) injections.
Other intervention name(s): STX-100
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol
Condition: Healthy Volunteers; Statins; Immune Modulation
Study type: Observational

Summary: 
      Background:

      - The drug rosuvastatin (also called Crestor) is used to lower cholesterol levels in people
      with elevated cholesterol levels. Recent studies have suggested that rosuvastatin may affect
      the immune system and reduce inflammation, but the reason for this effect is unclear.
      Researchers are interested in testing the effect of rosuvastatin on the immune systems of
      healthy volunteers with good cholesterol levels.

      Objectives:

      - To evaluate the effect of rosuvastatin on the immune systems of healthy volunteers.

      Eligibility:

      - Healthy individuals at least 18 years of age who have an acceptable blood level of LDL
      cholesterol (below 160).

      Design:

        -  Participants will be screened with a medical history and physical examination, as well
           as blood tests to check general health, cholesterol levels, liver function, and the
           C-reactive protein (which responds to inflammation).

        -  Participants will not be permitted to take most prescription and over-the-counter
           medications that affect the immune system, including antihistamines and certain pain
           relievers. For 1 week before the study, participants will have a wash-out period without
           any of these medications.

        -  Participants will take rosuvastatin daily for 4 weeks, always in the evening (to ensure
           consistent blood sample results).

        -  Participants will provide blood samples at the following time points: (1) immediately
           before the start of the rosuvastatin treatment, (2) after 2 weeks of treatment, (3)
           after 4 weeks of treatment, and (4) 2 weeks after the end of treatment.
    

Detailed description: 
      Statins are drugs that inhibit cholesterol synthesis and are used extensively for primary and
      secondary prevention of heart disease. Their benefit to patients with heart diseases appears
      to exceed that predicted from cholesterol lowering alone. A recent study has found benefits
      of statin therapy in patients with normal cholesterol and high C-reactive protein, a marker
      of inflammation, suggesting that statins exert an anti inflammatory effect in addition to the
      well known cholesterol lowering activity. Studies in mice have revealed mixed observations
      regarding the role of statins in inflammation. Therefore the Center for Human Immunology,
      Autoimmunity and Inflammation is conducting this trial to study the effects of statins on the
      immune system and the inflammatory response in healthy volunteers with normal cholesterol
      levels, and normal or elevated C-reactive protein levels.

      The primary objective is to characterize the immune system before and during statin therapy.
    

Time perspective: Prospective
Keywords: Statins; Immune Modulation; Healthy Volunteer
Myomectomy During CS: A Retrospective Cohort Study
Condition: Cesarean Section; Uterine Fibroid
MeSH terms: Leiomyoma
Study type: Observational

Summary: 
      To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant
      women with uterine fibroids.
    


Intervention name(s): Myomectomy
Intervention type(s): Procedure
Intervention description(s): Surgical removal of uterine fibroid
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women with uterine fibroid during the index pregnancy
Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent
Condition: Leiomyoma; Leiomyomatosis; Uterine Neoplasms
MeSH terms: Leiomyoma; Myofibroma; Uterine Neoplasms; Leiomyomatosis
Study type: Interventional
Phase: Phase 1

Summary: 
      A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock™ in
      the treatment of uterine fibroids by embolization with respect to clinical & imaging outcome
      with comparison of primary safety endpoints to Embosphere.
    

Detailed description: 
      The purpose of the study is to conduct a comparison between BeadBlock™ and Embosphere in
      uterine fibroid embolization. Baseline and follow-up MR Imaging data will be made with
      respect to changes in fibroid and uterus perfusion and fibroid and uterine volume. This is a
      12 months study (12 month follow up for all enrollees). The primary end-point will be the
      degree of fibroid devascularization as seen at contrast-enhanced MRI performed 3 months (+/-
      15 days) after UAE procedure. In addition we will assess symptom reduction in patients that
      have undergone uterine fibroid embolization with Bead Block™ and Embosphere®.

      Primary Objective 1. To assess the change in fibroid devascularization as seen at
      contrast-enhanced MRI performed after UAE and at three (3) months (+/- 15 days) following the
      UAE, and compare the changes between BeadBlock™ and Embosphere.

      Secondary Objective

      1. To assess the change in fibroid devascularization as seen at contrast-enhanced MRI
      performed several days after UAE and 6 months (+/- 15 days) following the UAE, and compare
      the changes between BeadBlock™ and Embosphere.

      Tertiary Objective

        1. To assess the change in uterine volume as seen at contrast-enhanced MRI performed
           several days after UAE, 3 months (+/- 15 days) and 6 months (+/- 15 days) following the
           UAE, and compare the changes between BeadBlock™ and Embosphere.

        2. To assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months
           (+/- 15 days) follow-up, as measured by the subscale of the UFS questionnaire, and
           compare the changes between BeadBlock™ and Embosphere.
    

Intervention name(s): Uterine fibroid embolization BeadBlock™; Uterine fibroid embolization Embosphere®
Intervention type(s): Device; Device
Intervention description(s): Intervention with BeadBlock Microspehere; Embosphere - control arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Leiomyoma; Leiomyomatosis; Uterine Neoplasms; BeadBlock; Embsophere; Embolization; Uterine fibroid embolization
Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized study evaluating the continued safety and efficacy of elagolix in the management
      of moderate to severe endometriosis associated pain in adult pre-menopausal women who
      completed 6 months treatment in pivotal Study M12-671 (NCT01931670).
    

Detailed description: 
      The study consists of 2 periods: a 6 month Treatment Period and a post treatment follow-up
      period of up to 12 months.

      Participants who received elagolix in the pivotal study who met all entry criteria continued
      to receive the same dose, either elagolix 150 mg once daily (QD) or elagolix 200 mg twice
      daily (BID) for up to an additional 6 months in this extension study; participants who
      received placebo in the pivotal study were randomized in a 1:1 ratio to receive either
      elagolix 150 mg QD or elagolix 200 mg BID for up to 6 months.

      An electronic diary will be used to collect endometriosis-associated pain, uterine bleeding,
      and analgesic medication use for endometriosis associated pain on a daily basis.
    

Intervention name(s): Elagolix
Intervention type(s): Drug
Intervention description(s): Elagolix tablets administered orally
Other intervention name(s): Orilissa™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endometriosis-associated pain; Elagolix; Gonadotropin-releasing Hormone Antagonist; Dysmenorrhea (DYS); Non-menstrual Pelvic Pain (NMPP); Dyspareunia