bioihbjkbjnl/mcl2 huggingface dataset:
Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder
Condition: Infection; Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Respiratory Aspiration; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin
      after inhalation of single 52.5 and 48.75 mg doses in COPD patients. In this study the 48.75
      mg dose will be administered for the first time using a new high dose strength (i.e. one
      capsule containing 75 mg powder = 48.75 mg ciprofloxacin) formulation. Safety investigations
      will focus on local tolerability in the lung and evaluate whether the patient can inhale the
      higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how
      the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this
      study will be used to decide whether the new dose strength is suitable for larger clinical
      trials planned for the COPD patients population.
    


Intervention name(s): Cipro Inhale (Ciprofloxacin, BAYQ3939); Cipro Inhale (Ciprofloxacin, BAYQ3939)
Intervention type(s): Drug; Drug
Intervention description(s): 32.5 mg ciprofloxacin corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation; 48.75 mg ciprofloxacin corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: 75 mg dose strength; Safety; Pharmacokinetics
Irrigation Endoscopic Decompression
Condition: Lumbar Spinal Canal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      To evaluate a new endoscopic technique for lumbar spinal canal decompression.
    

Detailed description: 
      104 consecutive patients suffering of neurogenic claudication were included in the study.

      Patients were operated using the irrigation endoscopic decompression technique. Mean Follow
      up was 28 months Primary outcome measures were assessed using the Oswestry Disability Index
      [19] and the modified Macnab Criteria All statistical calculations were done using computer
      programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA)
      version 15 for Microsoft Windows
    

Intervention name(s): Irrigation Endoscopic Decompressive Laminotomy
Intervention type(s): Procedure
Intervention description(s): 2 portals 0.5cm were used one for the endoscope and the other for instruments. For every additional level one portal is added. The endoscope and instruments are directly placed over the surface of lamina without any dissection and saline under pump pressure is used to open a potential working space. Unilateral laminotomy/laminectomy is performed according to the severity of stenosis, followed by bilateral decompression beneath the midline structures.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IEDL; irrigation endoscopic decompressive laminotomy; irrigation endoscopic decompression; minimally invasive spine surgery; endoscopic decompression; spinal stenosis
Static Balance Disorders in Patients After Surgical Treatment of Hip Acetabular Fractures
Condition: Hip Fractures; Acetabular Fracture; Balance; Distorted; Disability Physical
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Observational

Summary: 
      The mechanism of maintaining balance is a complex phenomenon, involving numerous systems of
      human body. High-energy trauma resulting in acetabular fracture damages some of the elements
      composing this delicate mechanism, potentially increasing the risk of falls in patients.
      There have not been any studies so far on balance levels in patients after surgical treatment
      of acetabular fractures.

      Questions/purposes

        1. Do balance disorders occur in patients after ORIF of acetabular fractures?

        2. Do surgical approach and fracture pattern influence balance level of patients?

        3. Should therapy programs include certain stabilometric parameters adequate especially for
           this type of injury?
    

Detailed description: 
      Methods Between 2014-2017, investigators evaluated 110 subjects: 55 patients after surgical
      treatment of acetabular fracture - the study population (mean age 43.6 ± 14.8 years) and 55
      healthy subjects - the clinical control group (mean age 43.8 ± 14.9 years).

      To ensure reliability of results, controls were individually matched to appropriate study
      population patients, in terms age, sex, body height and mass.

      The study was conducted in Public Hospital and the protocol was approved by the Commission of
      Ethics (SKE 01-21/2014).

      Investigators measured static balance in double leg stance (eyes open/eyes closed) for 30s on
      CQStab2P, a double module stabilometric platform.

      The pain component of the Harris Hip score and the quality of fracture reduction (according
      to Matta's criteria) in digitized anteroposterior and two oblique view radiographs were
      analyzed.
    

Intervention name(s): postural stability measurements
Intervention type(s): Procedure
Intervention description(s): Static balance assessment on bi-module stabilometric platform CQStab2P. It registers the movement of centre of foot pressure (COP).
Harris hip score- disability assesment
Other intervention name(s): harris hip score
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population involved 55 patients after surgical treatment of hip acetabular
        fracture.
Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome; Neuropathic Pain
MeSH terms: Neuralgia; Carpal Tunnel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of the interferential laser therapy in
      the wrist and hand pain and disability reduction and force improvement in the carpal tunnel
      syndrome. Subjects are patients diagnosed of carpal tunnel syndrome who have been prescribed
      laser therapy. Settings: Ramon y Cajal Hospital. Department of Rehabilitation. Physical
      therapy unit. Electrotherapy section. Occupational Therapy. Department of Neurology.
    

Detailed description: 
      The spatiotemporal superposition of two independent and opposite beams of laser generates a
      constructive interference pattern that increases the therapeutic effects in the irradiated
      tissue. Patient suffering pain from diagnosed carpal tunnel syndrome will receive
      conventional or interferential laser therapy. This is a comparative randomized and double
      blind clinical study. Two identical lasers in near infrared range will be used. Frequency of
      sessions: daily. Irradiated technique: manual, contact and punctual. Pain will be evaluated
      by visual analog scale at rest and during analytical wrist movement. Disability will be
      evaluated by the DASH and BOSTON questionnaire. Evaluation will take place at pre and
      post-treatment times.
    

Intervention name(s): Interferential Laser Therapy
Intervention type(s): Device
Intervention description(s): PROCEDURE: Interventional group: Two independents and identical probes. Energy dose per point and per probe: 5 J. Continuous emission. Treatment time:8 minutes. Sessions: 10. Frequency of the sessions: daily. Irradiation technique: handily, in contact and at 7 points over distal pathway of median nerve.Control group: Sham laser:650 nm.Scanning mode.Outpout power:1 mW.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Carpal Tunnel Syndrome; Interferential laser therapy; Low-level laser therapy; Neuropathic pain; Median nerve compression
A Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121/Tezacaftor/Deutivacaftor
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability of a fixed-dose
      combination tablet (FDC) of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA).
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): VX-121/TEZ/D-IVA
Intervention type(s): Drug
Intervention description(s): FDC tablet for oral administration.
Other intervention name(s): VX-121/VX-661/CTP-656; VX-121/VX-661/VX-561; VX-121/tezacaftor/deutivacaftor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers
Condition: Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine if rifaximin, administered daily has an
      effect on the cytochrome P450 (CYP) isoenzyme 3A4, by examining any changes in the
      pharmacokinetics of midazolam (a CYP3A4 substrate), when co-administered.
    

Detailed description: 
      This is a single-site, single-arm, open-label, drug-interaction study that examines the
      effect of rifaximin (RFX), 550 mg 3 times daily (TID; 1650 mg/day), on orally administered
      (PO) midazolam (MDZ) 2 mg (administered as a 2 mg dose in 1 mL of midazolam HCL Syrup; 2
      mg/mL) when dosed for 7 and 14 consecutive days, respectively.
    

Intervention name(s): rifaximin
Intervention type(s): Drug
Intervention description(s): 550 mg TID
Intervention MeSH terms: Rifaximin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: rifaximin; midazolam; pharmacokinetics
SSAT061: PK of DTG and EVT/COBI in Healthy Volunteers
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to look at the levels of three HIV medications: dolutegravir,
      elvitegravir and cobicistat in blood after the drug intake has been stopped in order to
      understand how long these drugs persist in the blood. The study will specifically look at
      blood levels of these three drugs after taking them every day for 10 days dolutegravir on a
      first stage and a combination of elitegravir and cobicistat in a second stage.

      If the participant decides to take part, the duration of the study will be up to 38 days plus
      a screening visit which will take place up to 28 days prior to the start of the study, and a
      follow up visit which takes place 7 to 14 days after the last dose of study medication.

      This study is not randomised which means that all participants will receive all study
      medications in the same order. The participant and the study doctor will know which study
      medications the participant is taking at all times during the study.
    


Intervention name(s): Dolutegravir, Elvitegravir and Cobicistat
Intervention type(s): Drug
Intervention MeSH terms: Dolutegravir; Cobicistat; Elvitegravir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Effects of Ten-Weeks Power Training on Neuromuscular Performance, Heart Rate Variability, Sleep Quality and Mobility in Persons With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease
      of the central nervous system, characterized by demyelination due to inflammation and
      degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter,
      brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic
      fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems.
      Strength training has been shown to improve strength and mobility in persons with MS.
    


Intervention name(s): Resistance training; Testing sessions
Intervention type(s): Other; Other
Intervention description(s): Ten weeks of resistance training; Testing sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional

Summary: 
      The purpose of this study is to compare three strategies for finding TB cases in a rural
      Sub-Saharan African setting: 1) Screening all attendees of primary care clinics for TB; 2)
      Conducting household contact investigations of newly diagnosed TB cases; 3) Providing
      incentives to newly diagnosed TB cases and their contacts to promote contact screening for
      TB. For each intervention, investigators will measure comparative effectiveness in terms of
      cases identified as well as the cost-effectiveness and feasibility of implementation.
    


Intervention name(s): Active TB case finding
Intervention type(s): Other
Intervention description(s): Active TB case finding (ACF) refers to any number of strategies used to identify individuals with active TB disease, outside of passive case finding. In passive case finding, individuals with symptoms present at health centers for diagnosis. In active case finding, the health system makes an effort to identify TB cases before they present passively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

      The aim of this trial is to investigate the efficacy and safety of insulin degludec in
      children and adolescents with type 1 diabetes mellitus.
    


Intervention name(s): insulin degludec; insulin detemir; insulin aspart
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Injected subcutaneously (under the skin) once daily. Dose individually adjusted.; Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.; Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cervical Stabilization Training on Individuals With Headache
Condition: Headache
MeSH terms: Headache
Study type: Interventional

Summary: 
      Headache is a common health problem. The most common headaches worldwide are migraine,
      tension-type headache (TTH), and cervicogenic headache (CGH). Due to the close anatomical
      relationship between the head and the cervical region, neck pain accompanies these headaches.
      The effects of cervical stabilization training including all of the cervical regions,
      thoracic regions, and the upper extremities in individuals with headaches are not yet known.
    

Detailed description: 
      Headache is a common health problem. The most common headaches worldwide are migraine,
      tension-type headache (TTH), and cervicogenic headache (CGH). Due to the close anatomical
      relationship between the head and the cervical region, neck pain accompanies these headaches.
      Most of the previous studies examined the effects of exercise programs such as
      Cranio-Cervical Flexion Exercises (CCFE), posture exercises, muscle strengthening, and
      stretching exercises of the neck and shoulder on headaches. These studies presented the
      beneficial effects of CCFE which mostly targeted strengthening the superficial neck and
      shoulder muscles. However, the effects of cervical stabilization training including all of
      the cervical regions, thoracic regions, and the upper extremities in individuals with
      headaches are not yet known.
    

Intervention name(s): Cervical stabilization exercises
Intervention type(s): Other
Intervention description(s): Patients learned the activation of deep cervical flexor and extensor muscles. Then, during the activity of deep cervical muscles, superficial cervical muscles and upper extremity muscles were also strengthened. Thus, it was aimed to strengthen all neck muscles and upper extremity muscles in different positions synchronously and to increase their endurance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Headache; Neck pain; Exercise
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams
      (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major
      depressive disorder (MDD) who have a partial response to ADT.
    


Intervention name(s): Rapastinel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rapastinel pre-filled syringes for weekly IV injections.; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Crystalline Lens Tilt Evaluation Using Swept-source Optical Coherence Tomography
Condition: Cataract Surgery
MeSH terms: Cataract
Study type: Observational

Summary: 
      The goal of this retrospective study is to quantify the physiological lens tilt of the phakic
      eye.

      The main question it aims to answer is:

      -What influence does misalignment or tilting of IOLs have on visual quality?

      Preoperative biometry data are compared with anterior segement OCT data.

      Measurements were obtained using high-resolution swept-source optical coherence tomography.
      The influence of biometric measurements on tilt is analyzed.
    

Detailed description: 
      The human (crystalline or phakic) lens is located in the capsular bag which is attached to
      zonules. Zonules are fibres, that hold the lens in place. In the course of life, an
      opacification on the lens occurs, which is called cataract. To replace the cloudy lens,
      cataract surgery is being performed and an artificial intraocular lens (IOL) is implanted in
      the eye, after the phakic lens is removed. Misalignment or tilting of IOLs can result in
      reduction of visual quality, therefore prediction of the position may be beneficial. Modern
      optical coherence tomography (OCT) devices already provide profound information about phakic
      lens tilt. Still there is little data on the values that influence the tilt of the
      crystalline lens. Before each cataract surgery, each eye is measured using biometry (IOL
      Master 700). However, a statement about the tilt cannot be made on the basis of the results
      of IOL Master 700. For this purpose, an anterior segment OCT is required (CASIA 2). In this
      study, preoperative biometry data are compared with anterior segment OCT data. A statistical
      analysis will then be performed to identify the biometric parameters that can predict phakic
      lens tilt.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between 21 and 100 years who received preliminary examinations as part of cataract
        surgery
      
Keywords: Cataract; CASIA2; IOL Master700
To Compare Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP
Condition: Cataract Senile
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The main objective of the trial is to assess the efficacy of the CT LUCIA 611P intraocular
      lens (IOL) with regard to the horizontal IOL position stability. The horizontal position
      collected at 1 month and 4 to 6 months post-operatively will be compared to the horizontal
      IOL position recorded at baseline (1 week post-operatively) as well as to the position
      stability of the reference IOL, CT ASPHINA 409MP.
    


Intervention name(s): Intraocular lens
Intervention type(s): Device
Intervention description(s): Implantation as part of cataract surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a double-blind, randomized, controlled study with two arms to evaluate
      JointStem as a treatment for subjects with osteoarthritis. Following a 2-week screening
      period, approximately 30 subjects will be randomly assigned into one of the following two
      arms in a 2:1 ratio (2 JointStem : 1 positive control). After each subject completes 6-month
      visit (Visit 6) and the data management team confirms all data have no issue, the individual
      database will be locked and the blinding will be open for the statistical analysis.Only
      subjects who are assigned will be requested to visit the study center for 9-month and
      12-month follow-up visits (Visits 7 and 8). To see long-term effects of JointStem, all
      subjects who complete Visit 6 will be requested to visit the study center at 24-month after
      the injection.
    


Intervention name(s): JointStem; Synvisc-One
Intervention type(s): Drug; Drug
Other intervention name(s): Active Comparator
Intervention MeSH terms: Hylan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment