bioihbjkbjnl/mcl2 huggingface dataset:
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
Condition: Cholestasis
MeSH terms: Cholestasis
Study type: Interventional
Phase: Phase 1

Summary: 
      In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking
      obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis [PBC],
      OCA, or both) the addition of linerixibat to OCA therapy may be considered following
      marketing approval. It is therefore important to characterize any potential effect of
      linerixibat on the pharmacokinetics of OCA in humans at clinically relevant dosages.
      Accordingly, a drug-drug interaction (DDI) study with linerixibat (potential perpetrator) and
      OCA (potential victim) will be conducted to inform both future clinical trials with
      linerixibat and the potential concomitant administration of these drugs in a clinical
      setting. This is a single-center, one part (with optional second part) open-label, single
      sequence crossover, drug interaction study to investigate the effect of linerixibat on plasma
      concentrations of OCA and OCA conjugates in healthy participants. Approximately 19
      participants will be enrolled in part A and further 19 participants in part B (if performed)
      in the study and will have a phone call follow-up till 7-14 days post-last linerixibat dose.
    


Intervention name(s): GSK2330672 (linerixibat); Obeticholic acid
Intervention type(s): Drug; Drug
Intervention description(s): GSK2330672 is available as a tablet with unit dose strength of 45 mg.; Obeticholic acid is available as a tablet with a unit dose strength of 10 mg (or 5 mg dependent on evaluation of Part A).
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a non-randomized study. Eligible subjects will receive OCA and OCA+linerixibat in a fixed sequence.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: linerixibat (GSK2330672), obeticholic acid, drug interaction, primary biliary cholangitis, pharmacokinetics
Comparison of Two Pre-prosthetic Surgical Techniques for Augmentation of Mandibular Vertical Ridge Defects
Condition: Alveolar Ridge Enlargement
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      The aim of this study is to compare two pre-prosthetic surgical techniques for augmentation
      of vertical mandibular ridge defects in preparation for implant placement, the first using
      customized ceramic membranes and the second using tenting titanium screws in conjunction with
      particulate bone graft and collagen membrane (modified sausage technique).
    

Detailed description: 
      Background: Expansion of the periosteum and soft tissue matrix by tenting has been described
      as a method of Guided Bone Regeneration (GBR) for reconstruction of atrophic alveolar ridges.

      Materials and Methods: The current study is a prospective controlled clinical trial,
      conducted on 14 patients, having about 7 mm of vertical bone height in the posterior mandible
      above the inferior alveolar canal. They are divided into 2 equal groups, each consisting of 7
      patients. The first group receives customized ceramic membranes with a vertical height 5 mm
      above the crest of the ridge to tent out the soft tissue matrix, while in the second group,
      tenting of the soft tissue is done by fixation of two tenting screws, particulate bone graft
      is packed then covered by collagen membrane that is fixed by bone tacks (modified sausage
      technique).
    

Intervention name(s): customised ceramic sheets (Group 1); modified sausage technique (Group 2)
Intervention type(s): Device; Combination Product
Intervention description(s): guided bone regeneration; guided bone regeneration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer
Condition: Esophageal
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located
      in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical
      efficacy has been shown in adult with head and neck cancer. The phase II study assessed the
      efficacy and safety of the combination of Nimotuzumab administered concomitantly with
      radiotherapy in patients with esophageal cancer tumours.
    

Detailed description: 
      Clinical efficacy has been shown in adult with head and neck cancer. The phase II study
      assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly
      with radiotherapy in patients with esophageal cancer tumours.
    

Intervention name(s): Nimotuzumab; Radiotherapy
Intervention type(s): Drug; Radiation
Intervention description(s): the nimotuzumab treatment; 200mg/w,weekly,5-6 weeks.; the Radiotherapy treatment;95%PTV A dose of 50-60Gy will be administered in 25-30 fractions ( 2 Gy /fraction)
Intervention MeSH terms: Nimotuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nimotuzumab esophageal radiotherapy
Effects of Steady-state TPV/RTV on the Single-dose Pharmacokinetics of Rifabutin and the Effects of Single-dose Rifabutin on the Steady-state Pharmacokinetics of TPV in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the effects of steady-state Tipranavir (TPV) / Ritonavir (RTV)
      (500mg/200mg bid) on the single-dose pharmacokinetics of Rifabutin (RFB) and to determine the
      effects of single-dose RFB on the steady-state pharmacokinetics of TPV 500mg (co-administered
      with RTV 200mg)
    


Intervention name(s): Tipranavir; Ritonavir; Rifabutin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Norvir-SEC®; Mycobutin®
Intervention MeSH terms: Ritonavir; Tipranavir; Rifabutin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lidocaine Infusion in Hystroscopy
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Lidocaine infusion in hystroscopic media versus oral diclofenac
    


Intervention name(s): Lidocaine Hydrochloride; Diclofenac Sodium
Intervention type(s): Drug; Drug
Intervention description(s): Lidocaine infusion on hystroscopic media during office hystroscopy; Oral Diclofenac Sodium
Intervention MeSH terms: Diclofenac; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Pediatric Subjects Using SAIZEN® Via Easypod™ Auto-injector for Growth Hormone Treatment
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a Canadian, Multicentre, Observational Registry to study Adherence and Long Term
      Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth
      hormone treatment from hospital and to assess the level of adherence of subject receiving
      SAIZEN® via Easypod™ .
    

Detailed description: 
      Subjects will be enrolled in a multicenter, longitudinal observational registry.
      Parents/subjects will provide their Informed Consent/assent to upload their data for
      populationbased analyses and optionally to adhere to a patient adherence support program
      designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will
      be primarily derived from the Easypod™ device combined with physician data entry of outcome
      measures. Data will be collected retrospectively and prospectively. This will allow the
      establishment of adherence profiles and explore the hypothesis that patient adherence support
      programs improve adherence and subsequent clinical outcomes. Collected data will be also
      analyzed in a multinational pooled analysis of comparable national studies.

      Primary Objective:

      - To assess the level of adherence of subjects prescribed SAIZEN® via easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject prescribed SAIZEN
           via easypod™

        -  To identify adherence subject profiling
    

Intervention name(s): Easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatotropin) administered by easypod™ as defined in SAIZEN® Canadian Product Monograph
Other intervention name(s): Saizen; Somatropin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric subjects 18 and under who are prescribed SAIZEN® (Health Canada approved
        indications) using the easypod™ auto-injector.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat
Condition: Submental Fat
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the Efficacy and Safety of MT921 in Subjects with
      Moderate to Severe Submental fat compared with Placebo.
    


Intervention name(s): MT921; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active ingredient; Normal Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess Zibotentan Pharmacokinetics in Participants With Moderate Hepatic and Moderate Renal Impairment
Condition: Hepatic Impairment; Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral
      dose of zibotentan in patients with moderate hepatic and moderate renal impairment in
      comparison to a matched healthy control group.
    

Detailed description: 
      This is a single-dose, non-randomised, open-label, parallel-group study.

      All participants will receive a single oral dose of 5 mg zibotentan under fasted conditions
      and will be involved in the study for approximately 5 weeks.

      Approximately 12 participants will be enrolled into each one of the 2 cohorts and receive the
      study intervention:

        -  Cohort 1: 12 participants with moderate hepatic impairment and moderate renal impairment
           as assessed at Screening

        -  Cohort 2: 12 healthy participants matched for age (± 10 years), gender, and BMI (± 20%)
           on a group level to participants in Cohort 1

      The study will comprise of the following study periods:

        -  A Screening Period of maximum 28 days (before dosing): participants will be screened for
           eligibility.

        -  A Residential Period of 8 days: participants will be admitted to the study centre in the
           evening on Day

        -  2, two days before administration of a single oral dose of zibotentan (Day 1).
           Participants will have final study assessments on Day 6 (120 hours post-dose) and will
           be discharged that day.
    

Intervention name(s): Zibotentan
Intervention type(s): Drug
Intervention description(s): All participants will receive a single oral dose of zibotentan capsule under fasted conditions.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two cohorts (patients and matched healthy subjects) to be enrolled for this study.
Approximately 12 participants will be enrolled into each one of the 2 cohorts and receive the study intervention:
Cohort 1 will enroll participants with moderate hepatic impairment and moderate renal impairment as assessed at screening.
Cohort 2 will enroll healthy participants
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Impairment; Hepatic Impairment; Healthy participants; Zibotentan; Pharmacokinetics; Safety
Effects Of Detrol LA On Memory And Cognition In Elderly Population
Condition: Memory; Cognition
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of the trial is to show that tolterodine ER has no effect on memory and
      other cognitive abilities in an elderly population
    


Intervention name(s): Tolterodine ER; Oxybutynin ER
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tolterodine Tartrate; Oxybutynin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Age of Blood in Children in Pediatric Intensive Care Units
Condition: Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      ABC PICU is a randomized clinical trial that will compare the clinical consequences of RBC
      storage duration in 1538 critically ill children. Laboratory and observational evidence
      points to serious concerns about the lack of safety and effectiveness of older RBCs,
      especially in more vulnerable populations. Physicians and institutions have been
      systematically transfusing fresh RBCs to some pediatric patients primarily because of beliefs
      that the use of fresh RBCs improve outcomes. Conversely, the standard practice of blood banks
      is to deliver the oldest RBC unit in order to decrease blood wastage. To provide much needed
      high quality evidence to answer the question "do RBCs of reduced storage duration improve
      outcomes?" The ABC PICU Trial will conduct a RCT comparing development of New or Progressive
      Multiple Organ Dysfunction Syndrome (NPMODS) in critically ill children transfused with
      either RBCs stored ≤ 7 days or standard issue RBCs (expected mean RBC storage duration of
      17-21 days).
    


Intervention name(s): Short storage RBC age
Intervention type(s): Biological
Intervention description(s): IND obtained to cover the expiration date on the red blood cell unit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Red blood cell transfusions; Red blood cell storage age; Pediatrics; Critical Care
A Study of the Safety and Acceptability of a Placebo Vaginal Film: FAME101
Condition: Safety of Vaginal Film Use
Study type: Interventional

Summary: 
      This is a phase I randomized trial assessing the safety of a single vaginal placebo film
      application. In order to develop a vaginal film which can provide extended release of an
      Antiretroviral (ARV), the film polymers and formulation have been altered from the cellulose
      and polyvinyl alcohol films used to deliver dapivirine and tenofovir in previous trials.
      Therefore, the proposed study will evaluate the safety and persistence of these film polymers
      when applied vaginally.
    

Detailed description: 
      This research study will involve the use of a placebo vaginal film. Investigators want to
      evaluate the safety of the film and understand the acceptability and length of time for the
      film to dissolve once inserted into the vagina. In future studies, this film may have
      medication added to it to deliver medication over an extended period of time (i.e. extended
      release).

      All of the eligible women will be randomized (distributed by chance, like rolling a dice) at
      the Enrollment Visit to one of four study groups. The groups will specify what day Visit 3
      will be performed.

      Participants will have an equal likelihood of being in any one of the four groups. Neither
      the participant nor the study staff can choose the group or can change the group the
      participant has been placed into. Regardless of which group the participant is in she will
      only use the film once during the study. Women in all of the study groups will have the same
      study visit schedule except for the timing of Visit 3.
    

Intervention name(s): Vaginal Film
Intervention type(s): Device
Intervention description(s): 2" x 2" vaginal film with no active drug
Intervention model: Single Group Assignment
Intervention model description: All participants will insert a placebo extended release vaginal film at Day 0. They are randomized to the timing of their first follow up visit (Day 3, 7, 10 or 14) to assess how long the film can be detected visually and/or one of its components remains detectable by biochemical assay in the lower genital tract.
Masking: None (Open Label)
Primary purpose: Supportive Care
Weight Regain After Consumption of Food Supplement and Interventional Diet Program
Condition: Obesity; Overweight; Weight Loss; Body Weight Changes; Weight Change, Body
MeSH terms: Overweight; Body Weight; Weight Loss; Body Weight Changes
Study type: Interventional
Phase: Phase 3

Summary: 
      Effect of the dietary supplement (FAT-BINDER DAMM) on weight regain after 9 months of control
      weight program
    

Detailed description: 
      -  60 participants will consume experimental product every day 3 sticks of the dietary
           supplement (1.4 grams/stick) during 12 months: 2 sticks should be consumed before lunch
           and 1 stick before dinner. During the 12 first weeks, each volunteer will be included on
           a low weight program (PPP) with an individual hypocaloric diet planning and regular
           physical adapted activity (PPP period). When PPP period is over, volunteers will
           continue consuming the product for 9 months more (Post-PPP period).

        -  60 participants will consume everyday 3 placebo sticks (1.4 grams/stick) during 12
           months: 2 sticks should be consumed before lunch and 1 stick before dinner. During the
           first 12 weeks, each volunteer will be included on a low weight program (PPP) with an
           individual hypocaloric diet planning and regular physical adapted activity (PPP period
           ). When PPP period is over, volunteers will continue consuming the product for 9 months
           more.
    

Intervention name(s): Fat-binder damm; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 sticks every day during 12 months; 3 sticks every day during 12 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Weight Loss; Body weight maintenance; Weight Change, Body; Saccharomyces Cerevisiae; Beta-glucans
A Study to Investigate a Research Drug as an Aid for Smoking Cessation in Chronic Cigarette Smokers (0364-007)
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of an investigational
      drug that may help individuals to stop smoking.
    


Intervention name(s): taranabant
Intervention type(s): Drug
Other intervention name(s): MK0364
Intervention MeSH terms: N-(3-(4-chlorophenyl)-2-(3-cyanophenyl)-1-methylpropyl)-2-methyl-2-((5-(trifluoromethyl)pyridin-2-yl)oxy)propanamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Trigger Point Dry Needling In Patient With Patellofemoral Pain Syndrome
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      This study intends to determine the effects of trigger point dry needling in patients with
      Patellofemoral pain Syndrome.
    

Detailed description: 
      This is a single blinded randomized controlled trial, will be conducted at District Head
      Quarter (DHQ) hospital Taunsa Sharif.

      Dry needling is a technique used to release myofascial trigger points. this study is planned
      to determine the effects of dry needling on quadriceps muscle in patients with Patellofemoral
      pain syndrome. The sample size was calculated to be n=92 through Open Epi tool version 3,
      with 95 % confidence interval (CI), and power 80%,

      After the completion of therapeutic protocols, the participants will be assessed with the
      help of Numeric Pain Rating Scale (NPRS), Algometer and Anterior Knee Pain scale along with
      knee Range of Motion(ROM)
    

Intervention name(s): Dry needling; Control
Intervention type(s): Other; Other
Intervention description(s): Hot Pack will be applied on Quadriceps muscles before session for general relaxation for 7-10 minutes. Stretching of quadriceps femoris muscle with 4 repetitions and 15 second hold per session will be performed. Strengthening exercises of 3 sets of 10 RM with progressive loading per session will be performed.
Then after wearing gloves and appropriate personal protective measures, a thin filiform needle will be inserted which will penetrate into the skin and stimulate underlying myofascial trigger points.; Hot Pack will be applied on Quadriceps muscles before session for general relaxation for 7-10 minutes. Stretching of quadriceps femoris muscle with 4 repetitions and 15 second hold per session will be performed. Strengthening exercises of 3 sets of 10 RM with progressive loading per session will be performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be two treatment groups of participants, One group will receive Dry Needling for releasing trigger points in Quadriceps along with therapeutic exercises whereas other will receive only therapeutic exercises
Masking: Single (Participant)
Primary purpose: Other
Keywords: Anterior Knee Pain Syndrome; Patellofemoral Syndrome
Comparative Study of the Therapy of Solar Lentigines With a Q-switched Rubin Laser Versus a Bleaching Cream
Condition: Solar Lentigines
MeSH terms: Lentigo
Study type: Interventional

Summary: 
      Benign pigmented lesions as solar lentigines are a common finding in Caucasian individuals.
      Their removal may be requested for aesthetic reasons.

      The goal of the study is comparing the efficacy and tolerance of two different therapy
      modalities established for treating solar lentigines.

      The right back of the hand side will be treated with the Q-switched SINON Rubin 694nm Laser,
      the left back of the hand side with a hydrochinon containing bleaching cream (Pigmanorm®
      cream).

      The investigators estimate that a physical therapy with a Q-switched Rubin laser system is
      more effective in the removal of solar lentigines than a topical chemical therapy with a
      hydrochinon containing bleaching cream.
    


Intervention name(s): Q-switched SINON Ruby Laser; Pigmanorm Cream
Intervention type(s): Device; Drug
Intervention description(s): Solar lentigines on the right back of the hand side are treated with the Q-switched SINON Ruby Laser at Baseline and if required at day 28.; Solar lentigines on the left back of the hand side are treated once a day during 7 weeks with Pigmanorm cream, a bleaching cream containing hydrochinon.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: solar lentigines; Q-switches Laser; bleaching cream