bioihbjkbjnl/mcl2 huggingface dataset:
Bone Regeneration With Mesenchymal Stem Cells
Condition: Mandibular Fractures
MeSH terms: Mandibular Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      Mandible fractures are a common cause of facial injury in adults. The autologous mesenchymal
      stem cell (AMSC) transplantation, is proposed as an alternative to the conventional graft
      treatment, improving bone neoformation.The objective was to evaluate the effectiveness of
      AMSCs application in mandibular fractures to reduce regeneration time and increase bone
      quality.
    

Detailed description: 
      Single blinded controlled clinical trial in patients with mandibular angle fracture. The
      patients were divided into: Study Group (SG): fracture reduction plus application of AMSCs,
      Control Group (CG): Same procedure without AMSCs. AMSCs were obtained from adipose tissue ,
      24 hrs before the procedure. Intensity and density were evaluated in normal bone and
      fractured bone, at 4 and 12 weeks after surgery using panoramic radiography and computed
      tomography. (CT)

      A total of 20 patients, 10 in each group were included. SG with a mean age of 31.2 ± 6.3
      years and CG 29.7 ± 7.2 years, all patients were male. Bone quality at week 4 SG 108.82 ± 3.4
      vs CG 93.92 ± 2.6 (p = 0.000) by panoramic radiography, SG 123 ± 4.53 vs CG 99.72 ± 5.72 (p =
      0.000) by CT. At week 12: SG 153.53±1.83 vs CG 101.81±4.83 (p= 0.000) by panoramic
      radiography, SG 165.4 ± 4.2 vs CG 112.05±2.1 (p= 0.000) by CT.

      The application of AMSCs presented at week 4 similar ossification values compared with normal
      bone and a 36.48 % higher ossification rate at week 12.
    

Intervention name(s): Application of autologous mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): within the surgical procedure, mesenchymal stem cells, were applied on the fracture site. Imaging by X-ray and CT and imaging analysis was done after fracture repair, at week 4 and week 12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mesenchymal Stem Cells; Treatment
Icotinib Hydrochloride Cream in Healthy Adults and Psoriasis Patients
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of Icotinib
      Hydrochloride Cream in healthy adults and patients with mild to moderate psoriasis.
    

Detailed description: 
      Icotinib Hydrochloride is a small-molecule epidermal growth factor receptor (EGFR) tyrosine
      kinase inhibitor, which has been approved for the treatment of advanced non-small-cell lung
      cancer (NSCLC) in China in its oral form. As EGFR is implicated in the pathogenesis of
      psoriasis, icotinib hydrochloride is being developed as a cream for the treatment of mild to
      moderate psoriasis. This is a single-center, randomized, double-blind, placebo-controlled
      study of icotinib hydrochloride cream by topical administration. The study is designed in two
      parts in healthy subjects (part 1) followed by patients with mild to moderate psoriasis (part
      2). 1% and 2% icotinib hydrochloride cream will be initially applied to healthy subjects.
      Once the study in healthy adults shows favorable safety and tolerability, a study in patients
      with mild to moderate psoriasis will be followed. Approximately 28 subjects will be enrolled,
      including 12 healthy subjects (Part 1) and 16 patients with psoriasis (Part 2).
    

Intervention name(s): 1% icotinib hydrochloride cream; 2% icotinib hydrochloride cream; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical administration for twice daily; Topical administration for twice daily.; Topical administration for twice daily.
Other intervention name(s): no other name; no other name; Blank Cream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: EGFR inhibitor; topical agent; psoriasis; phase 1
Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of
      the number of asthma exacerbations in children with mild persistent asthma. Treatment
      medication will be administered as follows: ciclesonide will be inhaled once daily, using one
      of the two dose levels versus placebo together with other corticosteroids used as
      intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a
      treatment period (12 months). The study will provide further data on safety and tolerability
      of ciclesonide.
    

Detailed description: 
      The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to
      treat children who have mild asthma.

      The study enrolled 240 patients. Participants were randomly assigned (by chance, like
      flipping a coin) to one of the three treatment groups-which remained undisclosed to the
      patient and study doctor during the study (unless there was an urgent medical need):

        -  Ciclesonide 100 µg

        -  Ciclesonide 200 µg

        -  Placebo (dummy inactive inhalation) - this is a metered-dose inhaler that looks like the
           study drug but has no active ingredient.

      All participants were asked to take two puffs from a metered-dose inhaler once daily, in the
      evening, for up to 12 months.

      This multi-center trial was conducted in Canada, Hungary and South Africa. The overall time
      to participate in this study was 12 months preceded by a baseline washout period of 3 to 4
      weeks. Participants made multiple visits to the clinic including a safety follow-up visit
      within 30 days of the last treatment.
    

Intervention name(s): Ciclesonide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ciclesonide metered-dose inhaler; Ciclesonide placebo-matching metered-dose inhaler
Other intervention name(s): Alvesco®
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide; Exacerbation
Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy
Condition: Surgery
Study type: Interventional

Summary: 
      The procedures of thoracotomy are among the most painful operations. In addition to
      post-thoracotomy pain, the outcomes of surgery are affected adversely by postoperative
      discomfort. Therefore, post-thoracotomy pain control can improve the satisfaction of patient
      and prevent postoperative complications such as pneumonia, atelectasis, or respiratory
      failure. Thoracic epidural analgesia (TEA) used to be widely considered as a standard
      technique for providing analgesia after a thoracotomy. However, TEA carries side-effects such
      as incomplete or failed block, epidural hematoma, abscess, hypotension, respiratory
      depression, or bradycardia, etc. Recently, thoracic paravertebral block (TPVB) is an
      alternative technique for TEA that may offer a comparable analgesic effect and a better side
      -effect profile for post-thoracotomy analgesia. When local anesthetic agents are used as
      single injection, they can provide analgesia for limited period. Various adjuvants have been
      tried in the past in order to enhance the duration and quality of postoperative analgesia.
      Previous studies with perineural dexamethasone demonstrated that it enhanced the duration of
      local anesthetic block. The mechanism of its action is blocking the nociceptive impulse
      transmission along the myelinated C fibers. Patient-controlled analgesia (PCA) devices have
      been shown to provide superior analgesia and greater patient satisfaction compared with
      intermittent administration. System of wire-less PCA provides remote monitoring, information
      management and PCA devices with high precision. The purpose of this research is to determine
      whether dexamethasone might prolong the duration of analgesia and improve the short-time
      outcomes when administered for TPVB along with local anesthetic agents in elective
      thoracotomy.
    


Intervention name(s): Ropivacaine; Dexamethasone; saline
Intervention type(s): Drug; Drug; Other
Intervention description(s): ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml; ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg; ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.9% saline 20ml
Other intervention name(s): ropivacaine hydrochloride; dxm; dex; normal saline
Intervention MeSH terms: Dexamethasone; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: paravertebral block; patient controlled analgesia; ropivacaine; dexamethasone
Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to develop a BCG challenge model for use in short term Phase I
      human trials capable of assessing the ability of TB drugs and/or vaccine-induced immune
      responses to impact in vivo mycobacterial replication as a method of assessing
      antimycobacterial agents and/or protective immunity elicited by vaccines or host-directed
      therapy. The trial will illuminate the nature of local and systemic immune responses to BCG
      and treatment response, as well as demonstrate our local capacity for newer, more innovative
      study designs.
    

Detailed description: 
      This is phase 1, open-label, randomized clinical protocol to develop a human challenge model
      using the licensed and available BCG VACCINE USP (TICE® strain) with and without INH or
      Rifampin (RIF). Part 1 will involve 10 participants who will be screened and consented, given
      an intradermal injection of BCG; five of these participants will receive oral INH for 3 days.
      Part 2 will involve 10 participants who will be screened and consented, given an intradermal
      injection of BCG; five of these participants will receive oral RIF for 7 days. All
      participants will undergo physical exams, clinical evaluations, blood draws, urine
      collections, skin biopsies, and pregnancy tests. This study will measure the rate of
      replication by utilizing qPCR and in vitro culture, systemic innate and adaptive immune
      responses, including humoral and cellular assay analyses and the evaluation and PPD/IGRA
      status.
    

Intervention name(s): BCG Vaccine USP; Isoniazid; Rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2x10^6 cfu Tice® BCG (ID); INH in the dose of 300 mg for three days post BCG injection.; RIF in the dose of 600 mg for seven days post BCG injection.
Other intervention name(s): BCG; INH; RIF
Intervention MeSH terms: Rifampin; Isoniazid; BCG Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      As exenatide slows the rate at which materials leave the stomach, it is likely to alter the
      rate of intestinal absorption of oral drugs when administered within a certain timeframe
      relative to exenatide. In addition, the residence time within the stomach of other medication
      may be prolonged and data from this study will help assess the change in residence time in
      the presence of therapeutic doses of exenatide. This study will also evaluate the
      relationship between blood levels of exenatide and parameters measuring rate of stomach
      emptying.
    


Intervention name(s): exenatide and placebo; Exenatide and placebo; Exenatide and placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Period 1 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day. Period 2 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day. Period 3 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day. A washout of at least 2.5 days will occur between each treatment period.; Period 1 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day. Period 2 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day. Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day. A washout of at least 2.5 days will occur between each treatment period.; Period 1 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day. Period 2 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day. Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day. A washout of at least 2.5 days will occur between each treatment period.
Other intervention name(s): Byetta; AC2993; synthetic exendin-4; Byetta; AC2993; synthetic exendin-4; Byetta; AC2993; synthetic exendin-4
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: diabetes; gastric emptying; exenatide; Byetta; Amylin; Lilly
Inflammatory Markers in Natural Orifice Hysterectomies
Condition: Gynecologic Disease; Inflammation
MeSH terms: Genital Diseases, Female; Inflammation
Study type: Observational

Summary: 
      The authors aimed to detect inflammatory marker changes in two natural orifice
      hysterectomies: single-port laparoscopic hysterectomy (SLH) and vaginal hysterectomy (VH).

      Between 2018 and 2019, data obtained from patients in the SLH and VH groups were reviewed
      retrospectively. The preoperative and postoperative hematocrit (HCT), hemoglobin (HB), white
      blood cell (WBC), platelet (PLR), and neutrophil-lymphocyte (NLR) ratios and values were
      compared as well as the demographic characteristics of the patients.
    


Intervention name(s): Single port laparoscopic systems
Intervention type(s): Device
Intervention description(s): The first assistant handles the scope from the patient's right side. The second assistant, who is positioned between the legs of the patient, inserts a uterine manipulator (Rumi System; Cooper Surgical, CT). At the beginning of the surgery, a 1.5 to 2.5 cm vertical incision is made within the umbilicus using the open Hasson approach. After the bottom retractor ring of the wound retractor component of the Octo-Port is inverted (DalimSurgNet, Seoul, Korea), it is inserted through the incision deep in the peritoneum. Carbon dioxide is insufflated through the gas valve of the Octo-Port to maintain intra-abdominal pressure at 10 to 12 mm Hg. Through the 10 mm channels of the Octo-Port, a 10 mm, 30° rigid laparoscope is introduced. Rigid laparoscopic instruments are introduced through the 5 mm channels of the Octo-Port. The utero-ovarian ligament or infundibulopelvic ligament, uterine vessels, and uterine ligaments are transected by using the 5 mm LigaSure vessel sealer device
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        women without any other medical problem who need hysterectomy for any condition
      
Keywords: inflammation mediators; lymphocyte activation; natural orifice endoscopic surgery; neutrophil activation; platelet activation; vaginal hysterectomy
Survival With Own Liver of Conventional Versus Laparoscopic Kasai for Biliary Atresia
Condition: Biliary Atresia
MeSH terms: Biliary Atresia
Study type: Interventional

Summary: 
      This study evaluated laparoscopic (videosurgery) versus conventional (open surgery) Kasai
      portoenterostomy (anastomosis of small intestine to the liver hilus) in children with biliary
      atresia. The study was stopped due to lower survival with native liver 6 months after the
      laparoscopic operation. Follow-up after 24 months confirmed superior results after
      conventional operation.
    

Detailed description: 
      Objective:

      A prospective observational study to compare survival with own liver in laparoscopic versus
      conventional Kasai portoenterostomy in patients with biliary atresia.

      Summary Background Data:

      Available studies on laparoscopic versus conventional Kasai portoenterostomy focus on
      short-term results, include limited numbers of patients and have design limitations.

      Methods:

      A consecutive series of patients underwent laparoscopic Kasai procedure from 2006 to 2007.
      Conventionally operated control patients consisted of a consecutive series of infants with
      biliary atresia operated from August 2003 to 2006. All data were ascertained prospectively
      using the European Biliary Atresia Registry / EBAR registration forms. Primary outcome
      measure was survival with own liver 6 months after Kasai without being listed for liver
      transplantation. An interim analysis was planned after data became available for the first 12
      patients who underwent laparoscopic Kasai procedure. In case of a significantly different
      interim outcome the follow-up period should be extended to 24 months until a final decision
      should be drawn.
    

Intervention name(s): Laparoscopic Kasai operation
Intervention type(s): Procedure
Intervention description(s): the Kasai procedure (hepatoportoenterostomy) is performed laparoscopically, thus not in open surgery.
Other intervention name(s): hepatoportoenterostomy; coelioscopie
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: biliary atresia - laparoscopy - kasai - portoenterostomy
Valproate Efficacy in Cocaine-Bipolar Comorbidity
Condition: Bipolar Disorder; Cocaine Dependence
MeSH terms: Cocaine-Related Disorders; Bipolar Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This proposal will test the efficacy of a promising pharmacological approach for the
      treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized,
      double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium
      (Valproate) plus treatment as usual compared to placebo plus treatment as usual in decreasing
      cocaine use and stabilizing mood symptoms among patients with comorbid cocaine dependence and
      bipolar disorder. Treatment as usual includes the use of lithium carbonate for mood
      stabilization plus supportive psychosocial treatment.
    

Detailed description: 
      Bipolar disorder has the highest rate of association with cocaine and other substance use
      disorders than any other major severe psychiatric syndrome. This comorbidity represents a
      major treatment challenge and is associated with severe disability, morbidity, and heightened
      risk for suicide.

      The aims of this study are:

        1. Examine the efficacy of valproate plus treatment as usual compared to placebo plus
           treatment as usual in decreasing cocaine use in patients with cocaine dependence and
           comorbid bipolar disorder.

        2. Determine whether primary vs. secondary cocaine dependence, bipolar subtype (depressed
           vs. manic/mixed) and the presence of additional substance use disorders moderate the
           association between treatment and cocaine use outcome.

        3. Assess the effects of medication compliance and mood symptoms as mediators of cocaine
           use outcome.
    

Intervention name(s): Valproate; Placebo; Lithium Carbonate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Valproate with dose titration to achieve blood levels within the therapeutic range; Control arm; All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder
Other intervention name(s): Divalproex sodium; Placebo control; Standard treatment
Intervention MeSH terms: Valproic Acid; Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar; Cocaine; Comorbidity
A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder
Condition: Social Anxiety Disorder; Anxiety Disorders
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in
      subjects with Social Anxiety Disorder
    


Intervention name(s): paroxetine
Intervention type(s): Drug
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Social Anxiety Disorder; Anxiety; Psychiatry