bioihbjkbjnl/mcl2 huggingface dataset:
Lateral Sinus Augmentation Using L-PRF as Sole Graft Material
Condition: Maxillary Diseases
MeSH terms: Maxillary Diseases
Study type: Interventional

Summary: 
      Severe maxillary atrophy occurs after extraction of teeth in poster maxilla due to
      dimensional changes occur after removal; besides, sinus membrane pneumatization causes
      alveolar bone resorption, different classification for remaining alveolar bone in the
      posterior maxilla were done. In this study, the ABC sinus classification was followed in case
      selection. A sinus augmentation is done with several techniques. Sinus membrane elevation is
      done with two different approaches, either the crestal approach or lateral window approach.

      Using biofiller material for sinus membrane elevation has been tried by many researchers,
      using a bone graft, platelet concentrates preparation, collagen membranes, tenting screws, or
      with implant tenting.

      In this study, sinus augmentation was performed using a lateral window approach using L-PRF
      as sole biofiller material in one group, xenograft as only biofiller material in the second
      group and mixed xenograft with L-PRF in the third group. Histomorphometric analysis was done
      from the core biopsy after three months of augmentation, and implant placement was done.

      After three months, prosthetic parts were placed. The results of this study show that the
      augmentation of the sinus using L-PRF mixed with bone graft is showing the best results
      followed by L-PRF only, and the least was xenograft.

      From this point of discussion, it can be considered that using L-PRF as sole biofiller
      material in sinus augmentation.
    


Intervention name(s): L-PRF; L-PRF mixed with xenograft; xenograft
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): sinus augmentation using L-PRf as sole graft material; sinus augmentation using L-PRF mixed with xenograft as sole graft material; sinus augmentation using xenograft as sole graft material
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effect of Food on Fixed-Dose Combination of MP-513 10 mg and Metformin XR 750 mg
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and pharmacokinetic characteristics of
      fixed-dose combination of MP-513 10mg and metformin XR 750mg administered in a high fat fed
      state versus fasting state to healthy male volunteers.
    

Detailed description: 
      1. Randomized, open-label, single-dosing, two-treatment, two-sequence, two-period,
           crossover design

        2. Wash-out period: 14 days from the first dosing

        3. Drug concentration analytical device: UPLC-MS/MS
    

Intervention name(s): FDC(MP-513 10mg/Metformin XR 750mg)
Intervention type(s): Drug
Other intervention name(s): HL1511
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Food Effect
Biomarkers in Samples From Patients With B-Cell Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
      doctors identify and learn more about biomarkers related to cancer.

      PURPOSE: This research study is studying biomarkers in samples from patients with acute
      lymphoblastic leukemia enrolled on ECOG-2993 clinical trial.
    

Detailed description: 
      OBJECTIVES:

        -  To identify microRNAs that behave as oncogenes or as tumor suppressor genes in B-lineage
           acute lymphoblastic leukemia (ALL) in vitro and in vivo.

        -  To examine if single microRNA or signatures of microRNA correspond to different clinical
           outcomes in cytogenetically distinct B-ALL groups.

      OUTLINE: RNA from archived samples are analyzed for microRNA expression profile in vitro and
      in vivo.
    

Intervention name(s): RNA analysis; cytogenetic analysis; microarray analysis; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled on E2993 who provided samples for research
      
Keywords: adult acute lymphoblastic leukemia in remission; B-cell adult acute lymphoblastic leukemia
A Study of ZSP1273 Tablets in Patients With Acute Uncomplicated Influenza A
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled, and active controlled
      clinical trial to assess the efficacy and safety of ZSP1273 tablets in the treatment of Acute
      Uncomplicated influenza A.
    


Intervention name(s): ZSP1273 600 mg; Placebo to Oseltamivir; Oseltamivir(oral); Placebo to ZSP1273
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 3 X 200-mg tablet taken orally; Placebo capsules matching oseltamivir2 X 75-mg; 2 X 75-mg tablet taken orally; Placebo capsules matching ZSP1273 600 mg
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy Study of Dysport RU and Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to assess the dose response versus placebo of a single treatment of
      Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of
      moderate to severe glabellar lines at maximum frown.
    


Intervention name(s): Botulinum toxin type A; Botulinum toxin type A; Placebo
Intervention type(s): Biological; Biological; Drug
Intervention description(s): I.M. (in the muscle) injection on day 1 (single treatment cycle); I.M. on day 1 (single treatment cycle); I.M. on day 1 (single treatment cycle)
Other intervention name(s): AbobotulinumtoxinA (DysportRU®); AbobotulinumtoxinA (Azzalure®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Food Effect Study of Besifovir in Healthy Subjects
Condition: Food Effect; Health Subjects
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the PK characteristics and the effect of food on the PK in healthy volunteers
      who receive Besifovir dipivoxil in fed versus fasted condition
    

Detailed description: 
      A randomized, open-label, 2-sequence, 2-period, single-dose cross-over clinical trial to
      investigate the pharmacokinetics incorporating a comparison of fed/fasted pharmacokinetics of
      Besifovir dipivoxil in healthy volunteers
    

Intervention name(s): Besifovir dipivoxil
Intervention type(s): Drug
Intervention description(s): 150mg Besifovir dipivoxil, single dose, oral
Other intervention name(s): Besivo tab
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Lu 31-130 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose with the study is to evaluate the efficacy and safety of Lu 31-130 in
      patients suffering from schizophrenia compared to placebo.
    

Detailed description: 
      Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the
      world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of
      schizophrenia. However, none of the available drugs is ideal, in particular because of their
      complex safety profile and the limited effectiveness against certain symptoms of the disease.
      Thus, only one dimension of the morbidity, that is, the positive symptoms, can be expected to
      respond to treatment whereas negative symptoms and cognitive deficits are, at best, only
      marginally targeted.

      Given this, there is no doubt that the current antipsychotic drugs leave much room for
      improvement and call for new, more effective pharmacotherapies in the treatment of
      schizophrenia. In the current study, patients suffering from schizophrenia and experiencing
      clinically significant symptoms of the disease will be included. In the current study,
      eligible patients will be randomised in a 2:1 ratio to blinded treatment with either Lu
      31-130 (3, 5, 7, 10 or 14 mg/day) or placebo for 8 weeks. The study includes 5 parts with
      increasing doses of Lu 31-130 (Part A [3 mg/day], B [5 mg/day], C [7 mg/day], D [10 mg/day],
      and E [14 mg/day]). A decision to initiate Part B [5 mg/day of Lu 31-130], C [7 mg/day of Lu
      31-130] or D [10 mg/day of Lu 31-130] will be based on safety and tolerability of the
      previous study part. Dependent on the safety, tolerability and PK data from Part D the study
      may proceed with Part E. The efficacy and the safety of Lu 31-130 will be evaluated in
      comparison to the pooled placebo group from all 5 study parts.
    

Intervention name(s): Zicronapine; Zicronapine; Zicronapine; Zicronapine; Zicronapine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Study Part A:
3mg; orally, film-coated tablets, once daily, 8 weeks; Study Part B:
5mg; orally, film-coated tablets, once daily, 8 weeks; Study Part C:
7mg; orally, film-coated tablets, once daily, 8 weeks; Study Part D:
2 x 5mg; orally, film-coated tablets, once daily, 8 weeks; Study Part E:
2 x 7mg; orally, film-coated tablets, once daily, 8 weeks; Study Part A, B, C, D and E:
Placebo; orally, film-coated tablets, once daily, 8 weeks
Other intervention name(s): Lu 31-130; Lu 31-130; Lu 31-130; Lu 31-130; Lu 31-130
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Antipsychotic; Lu 31-130
AMP002 Phase III Contraceptive Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a single-arm, open-label, Phase III study in approximately 100 sites in the United
      States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of
      pregnancy.
    

Detailed description: 
      Through assessments including pelvic examination, laboratory procedures, and medical and
      gynecological history, subjects will be screened for eligibility in order to enroll
      approximately 1349 subjects into the study. After a screening period of up to 60 days,
      enrolled women will receive study drug. Each woman will participate in the study until after
      she has completed treatment during seven study cycles. Women who have individual cycles that
      do not meet the criteria for an evaluable cycle will not have those cycles replaced by
      subsequent cycles in order to provide a total of seven evaluable cycles.
    

Intervention name(s): AMPHORA
Intervention type(s): Drug
Intervention description(s): non-hormonal contraceptive vaginal gel
Intervention model: Single Group Assignment
Intervention model description: Single Arm, unblinded
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate Relative Bioavailability and Food-Effect of HA121-28 Tablet B in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be divided into 2 parts. The first part is a relative bioavailability study of
      HA121-28 tablet A and HA121-28 tablet B, and the second part is a food effect study of
      HA121-28 tablet B. Both Parts are single-dose, randomized, open-label, two-period crossover
      study to evaluate relative bioavailability HA121-28 tablet B in healthy subjects and the
      effect of food on pharmacokinetic profile of HA121-28 tablet B, respectively.
    


Intervention name(s): HA121-28 tablet B; HA121-28 tablet A
Intervention type(s): Drug; Drug
Intervention description(s): HA121-28 tablet B 200 mg; HA121-28 tablet A 200 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Repeat Dose Safety Study for Compound to Treat Anemia
Condition: Kidney Disease
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety and tolerability of repeat doses of
      compound 1278863A in healthy subjects.
    

Detailed description: 
      Compound 1278863A is a novel small molecule agent, which stimulates erythropoiesis through
      inhibition of hypoxia-inducible factor (HIF)-prolyl hydroxylases (EGLNs). This compound is
      being developed for the treatment of anemia. Compound 111427 was the first administration of
      compound 1278863A to investigate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of single oral doses up to 300 mg in healthy adult subjects. This study,
      PHI112842, will be the first administration of compound 1278863A to investigate the safety,
      tolerability, pharmacokinetics, and pharmacodynamics of repeat oral doses up to 300 mg for 14
      days in healthy adult subjects. At least 6 subjects will complete each cohort. Multiple blood
      samples for pharmacokinetic analyses will be obtained post-dose in each cohort. Safety will
      be assessed by measurement of vital signs, cardiac monitoring, collection of adverse event
      assessments and laboratory safety tests. Blood samples will be collected for pharmacodynamic
      analyses.
    

Intervention name(s): 1278863; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 15mg, 25mg, 50mg, 150mg; matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Safety; tolerability
Quetiapine Augmentation for Treatment-resistant PTSD
Condition: Combat Disorders; Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the response of veterans with PTSD without an optimal
      response to paroxetine to quetiapine augmentation versus placebo.
    

Detailed description: 
      This is a two-site study designed to evaluate the efficacy and safety of quetiapine
      augmentation of paroxetine treatment in veterans with PTSD who have failed to respond to
      paroxetine treatment.

      In Phase I, eligible patients will take open-label paroxetine (up to 60 mg daily) for 8
      weeks. Patients who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS
      score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be
      eligible for the second phase. In Phase II, patients will continue taking open-label
      paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) or
      placebo for 8 weeks in a double-blind fashion.
    

Intervention name(s): Open Label (OL) Paroxetine; Placebo; Quetiapine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Open-label Paroxetine; Double-blind placebo taken with OL paroxetine; Double-blind quetiapine taken with OL paroxetine
Other intervention name(s): Paxil; sugar pill; Seroquel
Intervention MeSH terms: Quetiapine Fumarate; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atypical Antipsychotics; Controlled Trial; Paroxetine; Quetiapine; Stress Disorders, Post-Traumatic; Treatment refractory; Treatment resistant
Effects of Sitagliptin on Gastric Emptying, Glycaemia and Blood Pressure in Type 2 Diabetes
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the acute effects of sitagliptin on postprandial
      glycemia, incretin hormones and blood pressure, and the relationship to gastric emptying,
      after a mashed potato meal in patients with type 2 diabetes.
    

Detailed description: 
      The purpose of this study is to (i) evaluate the acute effects of the dipeptidyl peptidase-4
      (DPP-4) inhibitor, sitagliptin (100mg once daily for two days), on gastric emptying,
      postprandial plasma glucose, insulin, glucagon and 'incretin' hormones (ie. glucagon-like
      peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)), blood pressure and
      heart rate after a high carbohydrate meal, and (ii) to determine whether the magnitude of the
      effects of sitagliptin on postprandial glycaemia and blood pressure is related to the rate of
      gastric emptying, in patients with type 2 diabetes.

      The rate of entry of carbohydrate into the small intestine is especially important in
      patients with diabetes mellitus. Sitagliptin is an orally administered inhibitor of
      dipeptidyl-peptidase-IV (DPP-IV), the enzyme responsible for the degradation of GLP-1. It is
      hypothesized that sitagliptin will increase the GLP-1 response to, and thereby slow gastric
      emptying and diminish the glycaemic and blood pressure response to, a carbohydrate-containing
      meal.

      Twenty healthy subjects (male and female) will be studied. Each subject will be studied on
      two occasions following treatment for 2 days with sitagliptin (100mg once daily) or matching
      placebo in a randomized, double blind, crossover design. Measurements of gastric emptying,
      intragastric meal distribution, blood glucose concentrations, gut hormones, blood pressure,
      splanchnic flow and appetite will be measured for 4 hours following ingestion of a mashed
      potato meal.
    

Intervention name(s): Sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100mg mane for 2 days; Inactive drug (Placebo)
Other intervention name(s): MK-0431-075, Januvia; Sugar pill
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: gastric emptying; glycemia; appetite; incretin hormones
Tight Vaginoscopy: a Simplified Novel Technique for a Better Vaginal Surgery
Condition: Endosalpingiosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Bivalve vaginal speculum insertion is a basic final step of vaginal examination.
      Unfortunately, it can't be inserted in young girls, virgins, nulliparous women with narrow
      vagina, women with vaginismus or patients with a history of previous vaginal surgery. In such
      cases, the value of vaginoscopy (examination of the vagina without speculum) is evident.
      Indications of vaginoscopy are expanding. In addition to confirmation of suspected vaginal
      masses or polypi diagnosis, it can be used to diagnose laceration of the vaginal wall in
      girls due to foreign body , traumatic injuries or sexual abuse. In a systematic review, the
      effectiveness and feasibility of using hysteroscopy for exploration of the immature genital
      tract (vaginoscopy) were documented.It may help in the diagnosis and treatment of gynecologic
      disorders in adolescent patients with an intact hymen, limited vaginal access, or a narrow
      vagina. Another recent systematic review highlighted the importance of Vagino-hysteroscopy as
      an easy way to gain access to the cervical canal and an important tool with which to diagnose
      and treat vaginal lesions.

      In practice, we notice leakage of excessive irrigating fluid per vagina with poor
      visualization during vaginoscopy. To the best of our knowledge, no study addressed a solution
      to improve visualization and success of vaginoscopic surgery. This study aims to test
      feasibility and doctor satisfaction of performing conventional diagnostic vaginoscopy if
      compared to tight diagnostic vaginoscopy and success on performing tight vaginoscopic surgery
      in patients with vaginal or cervical lesions.
    


Intervention name(s): Tight vaginoscope
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Diaphragmatic Breathing During Virtual Reality Exposure Therapy for Aviophobia
Condition: Fear of Flying
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The study investigated the effect of diaphragmatic breathing as an additional coping strategy
      during Virtual Reality Exposure Therapy in patients with aviophobia. The authors assumed that
      diaphragmatic breathing (DB) would lead to less fear and physiological arousal during the
      VRET and to an enhanced treatment outcome
    

Detailed description: 
      Patients with aviophobia received treatment in Virtual Reality with or without DB. The
      authors assumed that adding DB to VRET would enhance treatment effects by reducing fear
      during exposure, thus improving the processing of the feared situation. The authors
      hypothesized that, as a result, self-efficacy would be increased in comparison to VRET alone.
    

Intervention name(s): Diaphragmatic breathing; Virtual Reality Exposure Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients trained in the technique of diaphragmatic breathing were instructed to take a breath by contracting the diaphragm and were trained to maintain their respiration frequency. They were told to inhale through the nose for four seconds and exhale through the mouth for six seconds (six cycles per minute). Patients then had five minutes to practice by following verbal breathing instructions provided over headphones. During VR exposure breathing instructions were provided via headphones. Diaphragmatic is thought to reduce arousal on the physiological level (Hazlett-Stevens & Craske, 2009) but at the same time not to divert attention from the feared situation to the same extent as other coping strategies; Exposure to fear-evoking stimuli is conducted more often in virtual environments using simulators or similar computer-technologies (Virtual Reality Exposure Therapy, VRET). One great advantage of using VR-technologies is that it is possible to create an environment which is highly controllable by its creators. Feared stimuli or scenarios can be varied on individual purposes and presented several times. This facilitates the practice of exposure-based treatments especially for situations or places difficult to access or requiring a considerable amount of time and/or money (e.g. being in war zones or a passenger on a flight), where in vivo exposures have often not been conducted or only in a limited manner (Mühlberger & Pauli, 2011)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diaphragmatic Breathing; Virtual Reality Exposure Therapy