bioihbjkbjnl/mcl2 huggingface dataset:
Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema
Condition: Pulmonary Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 2

Summary: 
      The clinical utility of bronchoscopic methods for achieving lung volume reduction has been
      evaluated in patients with advanced emphysema because these procedures are uniformly safer
      than surgical volume reduction. These include one-way valves, or bronchial occlusive devices
      to collapse emphysematous regions of lung and bronchial fenestration with bypass stents to
      improve expiratory flow, wire coils implants that compress the airway and thermal vapor
      ablation that causes an acute injury with subsequent fibrosis and reductions in volume.
    

Detailed description: 
      Biologic lung volume reduction (BioLVR): it is a novel endobronchial approach, which uses a
      Biological agents aiming to reduce lung volume by blocking off the most emphysematous areas
      with a rapidly polymerizing sealant. The mechanism of action involves resorption atelectasis
      from airway occlusion, subsequent airspace inflammation, and then remodeling. This remodeling
      will lead to scarring that induces contraction of lung parenchyma and functional volume
      reduction can be expected within 6-8 weeks. Biological lung volume reduction occurs
      independent of the presence or absence of collateral ventilation.
    

Intervention name(s): Bronchoscopic Lung volume reduction
Intervention type(s): Procedure
Intervention description(s): Fiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Belatacept in Renal Transplantation With Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores
Condition: End-Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      This will be a pilot study to investigate the use of belatacept (BMS) therapy in kidney
      transplant patients who have a MAPI score of greater than or equal to 8. The MAPI (Maryland
      Aggregate Pathology Index) score is a preimplantation donor scoring system which has five
      histopathological parameters that impact long-term kidney outcomes. Many kidney transplant
      recipients use calcineurin inhibitors (CNIs) as one of their anti-rejection medi cations.
      Kidney function may be affected by anti-rejection medications known as calcineurin inhibitors
      (CNIs). Sometimes CNIs can lead to toxicities and eventually loss of the kidney or episodes
      of chronic allograft nephropathy (CAN). Avoiding CNI immunosuppression and using belatacept
      therapy (BMS) instead, may be associated with improved kidney transplant outcomes.
    


Intervention name(s): Belatacept
Intervention type(s): Drug
Intervention description(s): Belatacept infusion intravenous at 10 mg/kg on post-operative days 1, 5, and weeks 2, 4, 8, 12; 5mg/kg intravenous dose at weeks 16, 20, 24, 28, 32, 36, 40, 44, and 48.
Other intervention name(s): Nulojix
Intervention MeSH terms: Abatacept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney Transplantation; Biopsy; Belatacept
Clinical Comparision of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal
Condition: Healthy
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      -  Objective: To compare clinical results of three types of manual tooth brushes on
           gingivitis and plaque removal efficacy.

        -  Material and Methods: This study is a single blind randomized trial with crossover
           design which involved 30 periodontally healthy individuals. At baseline professional
           plaque removal and oral hygiene instruction are performed for all the students, then
           they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores
           are measured using plaque and gingival indices (PI and GI). Then subjects are instructed
           to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed
           again. After passing one-week period for wash out, subjects don't brush for 1-2 days and
           indices are recorded again. The same procedure are done for Cross action, and Butler 411
           tooth brushes respectively.
    

Detailed description: 
      This study is a single blind randomized trial with crossover design which involved 30
      periodontally healthy individuals. At baseline professional plaque removal and oral hygiene
      instruction are performed for all the students, then they are asked to avoid brushing for 1-2
      days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices
      (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and
      then, GI and PI indices are assessed again. After passing one-week period for wash out,
      subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done
      for Cross action, and Butler 411 tooth brushes respectively.
    

Intervention name(s): toothbrush
Intervention type(s): Device
Other intervention name(s): Pulsar, Crossaction, Butler toothbrush
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: toothbrushing; plaque control; gingivitis
A Study of MK-0616 in Participants With Moderate Renal Impairment (MK-0616-007)
Condition: Moderate Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This purpose of this study is to compare the pharmacokinetics (PK) of a single dose of
      MK-0616 in participants with moderate renal impairment (RI) to those of healthy matched
      control participants. This study is being conducted to assess the impact of moderate renal
      insufficiency on the PK of MK-0616.
    


Intervention name(s): MK-0616
Intervention type(s): Drug
Intervention description(s): 10 mg capsule administered orally
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Measurement Properties of the Turkish Version of the Patellofemoral Pain and Osteoarthritis Subscale of the KOOS
Condition: Patellofemoral Pain Syndrome; Patellofemoral Osteoarthritis; PROMs
MeSH terms: Osteoarthritis; Patellofemoral Pain Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to translate and culturally adapt the subscale of the Knee
      Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF)
      into Turkish, and to determine the measurement properties of the Turkish version.
    

Detailed description: 
      Patellofemoral pain and patellofemoral osteoarthritis are highly prevalent knee disorders
      associated with pain and functional limitations. Patient-reported outcome measures (PROMs)
      are suggested for clinical and research use; however, there is a lack of objective
      disease-specific PROMs for patellofemoral pain and osteoarthritis. The purpose of this study
      is to translate and culturally adapt the subscale of the Knee Injury and Osteoarthritis
      Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) into Turkish, and to
      determine the measurement properties of the Turkish version.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with patellofemoral pain and OA
      
Keywords: Patellofemoral Pain Syndrome; Patellofemoral Osteoarthritis; Patient-reported outcome measures; PROMs; Validity; Reliability
A Randomized Trial Comparing EC-wPversus EP-wP as Adjuvant Therapy for Operable Breast Cancer Patients Less Than 40 Years Old
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Manifold data revealed that young breast cancer patients are characterized by aggressive
      clinical history. The purpose of this study is to evaluate the efficacy and safety of
      different strategies incorporating paclitaxel to anthracycline-based regimens in young breast
      cancer patients.
    


Intervention name(s): Epirubicin; Cyclophosphamide; Paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 75 mg/m2 every-3-week for four cycles; 600 mg/m2 every-3-week for four cycles; 175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Teneligliptin-Glimepiride DDI Study
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, one sequence study to investigate the pharmacokinetic drug interaction between
      Teneligliptin and Glimepiride in healthy male subjects
    


Intervention name(s): Teneligliptin+Glimepiride
Intervention type(s): Drug
Intervention MeSH terms: Glimepiride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetics of Dioxidin, Solution for Topical and External Use, 0.25 mg/ml and Dioxidin, Solution for Infusion and External Use, 5 mg/ml in Healthy Volunteers
Condition: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aimed for:

        1. To study the safety of the drug Dioxidin, solution for topical and external use;

        2. To determine the concentrations of the active substance of the studied drugs Dioxidin,
           solution for topical and external use, and Dioxidin, solution for infusion and external
           use in discrete time intervals;

        3. To study pharmacokinetics of the drug Dioxidin, solution for topical and external
           application;

        4. To determine the absolute bioavailability of the drug Dioxidine, solution for topical
           and external use.
    


Intervention name(s): Hydroxymethylquinoxalindioxyde
Intervention type(s): Drug
Intervention description(s): Dioxidin (Hydroxymethylquinoxalindioxyde), solution for topical and external use, 0.25 mg/ml, applied as:
A - single rinsing of the oropharynx with 15.0 ml of the drug solution for at least 30 seconds B - single irrigation of the oropharynx by spraying the preparation 4 times with a spray nozzle C - irrigation of the skin on the back by spraying the preparation 4 times from a distance of 10 cm on 1% of the body surface using a spray nozzle and exposing the solution for 30 minutes or D - Dioxidin (Hydroxymethylquinoxalindioxyde), solution for infusion and external application, 5 mg/ml, single intravenous 5 mg/ml in 1 ml
Other intervention name(s): Dioxidin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluation of Geistlich Fibro-Gide® + CAF in Comparison to CTG + CAF for the Treatment of Recession Defects at 6 Months
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich
      Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or
      II recession defects at 6 months post treatment.
    

Detailed description: 
      This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich
      Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or
      II recession defects at 6 months post treatment.

      A total sample size of 30 subjects (n=30) will be evaluated at 3 centers with 4
      investigators. Power analysis based on 80% power and past McGuire/ Scheyer matched-pair
      defect recession coverage studies, with one-sided confidence interval 0.025, indicates that
      in order to detect a 12% difference in root coverage with ± 15% standard deviation a patient
      sample of 25 should be used . Given the multi-center nature of this study and the intention
      to follow patients long-term, with normal attrition, 30 subjects will ensure adequate
      long-term follow-up and provide a "power buffer" for any outcome differences that might be
      seen between centers.

      30 Patients with Miller Class I or II recession defects on bilateral sites will be treated
      randomly with coronally advanced flap (CAF) in combination with either Geistlich Fibro-Gide
      (GFG =Test) on one side, and Connective Tissue Graft (CTG = Control) on the contralateral
      side of the mouth. Follow-up visits after visit 2 surgery will be conducted at week 1,2, 4,12
      and 24 and in the long term after 1,3 and 5 years.
    

Intervention name(s): Geistlich Fibro-Gide; Connective Tissue Graft (CTG
Intervention type(s): Device; Procedure
Intervention description(s): Surgical recession root coverage with coronally advanced flap in combination with Geistlich Fibro-Gide; Surgical recession root coverage with coronally advanced flap in combination with CTG
Other intervention name(s): Coronally advanced Flap (surgery/ procedure); Coronally advanced Flap (surgery/ procedure)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split-mouth, randomized
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingival Recession; Fibro-Gide; CAF; CTG; Geistlich
Exhaled NO as a Biomarker of Gestational OSA and Persistence Postpartum
Condition: Pregnancy; OSA
Study type: Observational

Summary: 
      This study will evaluate the presence or absence of Obstructive Sleep Apnea (OSA) in the
      third trimester of pregnancy and again postpartum.
    

Detailed description: 
      This is a prospective cohort study to evaluate the presence or absence of OSA in the third
      trimester of pregnancy and again postpartum. The investigators will use the Watch-PAT200®
      device as their accepted standard for diagnosis of obstructive sleep apnea.

      When enrolled, women will be taught how to use the Watch-PAT200® via a company produced video
      that will be shown in the clinic and will be available via YouTube for review later if
      needed. They will also complete the Berlin Questionnaire. The patient will then use the
      Watch-PAT200® device overnight to evaluate for obstructive sleep apnea. This will be
      performed between 32-36 weeks gestation. Apnea-hypopnea indices (AHI) will be calculated and
      an AHI>5 will be considered diagnostic for OSA.

      The next morning when the patient returns the Watch-PAT200® device they will exhale into the
      NIOX MINO® to assess their exhaled nitric oxide levels. This will be performed between
      800-1000 am by one of the study personnel.

      The patient will also wear the Watch-PAT200® device the first postpartum night. The entire
      process will be repeated between 6-8 weeks postpartum.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women between 32 0/7 prior to 35 6/7 weeks gestation
      
Keywords: Obstructive Sleep Apnea
VNS-induced Corticospinal Plasticity
Condition: Stroke
Study type: Interventional

Summary: 
      The goal of this study is to learn more about the connections between the brain, spinal cord,
      and muscles and how these connections can be strengthened after neurological injury.
    

Detailed description: 
      Non-invasive stimulation techniques can be used to appropriately time converging inputs to
      induce changes in cortical output circuits of human primary motor cortex, a neuromodulatory
      protocol known as paired-associative stimulation (PAS). Experiments seek to examine
      interactions between cortical PAS and non-invasive vagus nerve stimulation (VNS) to
      understand the extent to which VNS amplifies cortical plasticity in humans.
    

Intervention name(s): Paired-Associative Stimulation (PAS); Vagus Nerve Stimulation (VNS); Sham Stimulation
Intervention type(s): Other; Other; Other
Intervention description(s): Simultaneous activation of connections in motor cortex via stimulation to the nerves and brain.; Recruits the auricular branch of the vagus nerve which activates brain structures that release chemicals mediating cortical plasticity.; Sub-threshold stimulation that does not activate neural structures.
Other intervention name(s): PAS; VNS; Sham
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Neuromodulation; Paresis; Neurorehabilitation
Cerebral and Peripheral Electrical Stimulation on Isometric Quadriceps Strength
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Quadriceps muscle strength is a key goal to be achieved in rehabilitation protocols for a
      variety of musculoskeletal conditions. Both cerebral and peripheral electrical stimulations
      can modulate motor brain areas involved in motor functions and has the potential to optimize
      muscle capacity. However, their effects on quadriceps function are lacking.

      This study aims to investigate the effects of transcranial direct current stimulation (tDCS)
      and peripheral electrical stimulation (PES) on quadriceps strength in healthy subjects.
    


Intervention name(s): Cerebral stimulation; Peripheral stimulation
Intervention type(s): Device; Device
Intervention description(s): Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various health conditions. However, its ergogenic effect still has controversial results.; Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia. Moreover, recent evidence has shown that PES can activate brain motor areas such as primary motor cortex.
Other intervention name(s): Transcranial direct current stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Whole-Body Hyperthermia Plus Chemotherapy in Treating Patients With Advanced Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma; Hyperthermia
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above
      body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from
      dividing so they stop growing or die. Combining chemotherapy with whole-body hyperthermia may
      kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of whole-body hyperthermia plus
      combination chemotherapy in treating patients who have advanced sarcoma that is metastatic or
      that cannot be surgically removed.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the combination of 41.8 degrees Celsius whole body hyperthermia (WBH)
      and ifosfamide/carboplatin/etoposide (ICE) chemotherapy in patients with advanced sarcoma.
      II. Assess the efficacy of this combination of therapy. III. Assess the clinical toxicity of
      WBH and ICE in these patients. IV. Obtain pilot data on the effect of WBH and ICE on cytokine
      induction in these patients.

      OUTLINE: Treatment of whole body hyperthermia (WBH) and ifosfamide/carboplatin/etoposide
      (ICE) is given every 3-4 weeks. On day 1 of the treatment, ifosfamide is administered
      intravenously over 60 minutes at the beginning of hyperthermia. Carboplatin is administered
      intravenously over 20 minutes while at the maximum temperature. Etoposide is administered
      intravenously over 60 minutes while receiving hyperthermia and on day 2 and 3 after
      hyperthermia. Patient disease status is reevaluated after 2 courses. If there is no disease
      progression, treatment continues for a maximum of 4 courses.

      PROJECTED ACCRUAL: Approximately 17-34 patients will be accrued for this study.
    

Intervention name(s): carboplatin; etoposide; ifosfamide; hyperthermia treatment
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention MeSH terms: Carboplatin; Etoposide; Ifosfamide
Primary purpose: Treatment
Keywords: recurrent adult soft tissue sarcoma; stage IV adult soft tissue sarcoma
Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children
Condition: Vitiligo; Pediatric ALL; Dermatologic Disease; Autoimmune Diseases
MeSH terms: Vitiligo; Skin Diseases; Autoimmune Diseases
Study type: Interventional

Summary: 
      Vitiligo is a auto immune that impact 2% of the global population, regardless from the
      phototype. Even though it affects patients in a physical way through loss of pigmentation, it
      is also impacting them on a mental/emotional way.11-12 Current treatments offer a symptomatic
      solution to patients, however the response rate can be low and results can be slow.

      Pediatric patients in vitiligo deserves special care as frequently (50%), the disease onset
      is before 20 years of age and, in 25% of the cases, it starts before the age of 10 years.13
      Also, the current treatments for children are limited since it can involve pain and
      claustrophobia. The combination therapy of the study could offer a painless and easy
      treatment to follow.

      If the combination of those two therapies can fasten and improve the response rate, this
      could be a good option to treat this condition not only in children, but also for adults
      patients.
    


Intervention name(s): exciplex; Tacrolimus ointment
Intervention type(s): Device; Drug
Intervention description(s): exciplex, excimer lamp 308nm produced by clarteis; tacrolimus monohydrate ointment 0.1% TACRUS
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vitiligo; excimer; 308nm
A Study to Evaluate the Safety and Tolerability of Using the SHR-1210 by Advanced Solid Tumor Subjects
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, multiple centers, non-randomized, dose escalation phase I trial to
      evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors The
      primary objective is to assess safety and tolerability of SHR-1210 and identify recommended
      phase II doses of SHR-1210 in patients with advanced solid tumors
    


Intervention name(s): SHR-1210
Intervention type(s): Biological
Intervention description(s): A fully human monoclonal immunoglobulin (IgG4 subtype)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PD-1/PD-L1 Advanced Solid Tumor Immunotherapy