bioihbjkbjnl/mcl2 huggingface dataset:
Oral Abuse Potential Study of Nalbuphine
Condition: Nalbuphine; Opioid Abuse
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid
      drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no
      active drug ingredients). The amount of nalbuphine levels in the blood will also be measured
      and the safety of the study drugs will be evaluated.

      This study has 2 parts: Part A and Part B.
    

Detailed description: 
      This study will be a single-dose, randomized, double-blind, active- and placebo-controlled,
      double dummy, 2-part, 7-way crossover study to determine the abuse potential of orally
      administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone
      solution and placebo, in non-dependent, recreational opioid users. The study will be
      conducted in a single clinical research unit (CRU).

      The purpose of Part A is to find the appropriate doses (a low, intermediate, and high dose)
      of nalbuphine solution to use in Part B. Part A of the study has two visits to the research
      clinic: a screening visit and dose selection visit. The visits will involve a 2-night stay (3
      days total) in the research clinic.

      In the Main Study Treatment Phase in Part B, the total estimated duration between each dose
      of study drug is approximately up to 7 days, of which the subject will spend 3 days/2 nights
      in the research clinic and approximately up to 4 days at home.

      The primary objective of the Main Study is to evaluate the abuse potential of orally
      administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone
      solution (the active comparator) and placebo in non-dependent, recreational opioid users.
    

Intervention name(s): Nalbuphine HCl solution; Placebo solution
Intervention type(s): Drug; Drug
Intervention description(s): nalbuphine solution administered at various strengths; Placebo
Other intervention name(s): NAL ER
Intervention MeSH terms: Nalbuphine; Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-dose, randomized, double-blind, active- and placebo-controlled, double-dummy, 2-part, 7-way crossover study.
Part A: Dose selection phase Part B: Treatment Periods 1-7
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: nalbuphine; abuse potential
Postoperative Analgesic Efficacy of Trans Abdominis Plane Block
Condition: Post Operative Pain; Cesarean Section Complications
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Transverse abdominis plane (TAP) block is an effective method to manage postoperative pain in
      patients with midline abdominal wall incisions. It is used frequently in many lower abdominal
      surgeries however its use after caesarean section is still new, and fewer studies are
      available. We conducted this study to see the analgesic effect of TAP block after caesarean
      section.
    

Detailed description: 
      The study is being conducted, at Combined Military Hospital Sargodha, Pakistan, to compare
      the analgesic efficacy of TAP block in providing post-caesarean analgesia with the control
      group, in terms of mean postoperative use of opioids after caesarean delivery. Sixty patients
      have been randomly selected using non-probability, consecutive sampling, and applying
      inclusion and exclusion criteria. The study design is a randomized controlled trial with
      thirty patients in each group undergoing elective caesareans. All patients will be given
      spinal anaesthesia with 1.5ml of 0.75% hyperbaric bupivacaine for a caesarean section.
      Patients in Group A will receive bilateral TAP block with 20ml of 0.25% bupivacaine while 20
      ml of saline will be injected in patients of Group B on both sides of midline after caesarean
      section, in addition to intravenous ketorolac 8hrly. The intensity of pain, total opioid
      consumption, presence of vomiting, and sedation will be noted until 24 hours after the
      surgery.
    

Intervention name(s): Trans abdominis plane block
Intervention type(s): Procedure
Intervention description(s): Ultrasound guided infiltration of local anaesthetic bupivacaine via 22G Quincke needle between internal oblique and trans abdominis muscle layers in abdominal wall.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: TAP block, C-section, Spinal anesthesia, localized field effects, analgesia, Postoperative pain and Opioids
Study To Estimate The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the time course of PF-04764793 concentration in
      the blood following dosing by oral inhalation from dry powder inhalers.
    


Intervention name(s): Treatment A; Treatment B
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled, 750/150, single dose; Inhaled, 750/150, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule
Condition: Bacillus Anthracis (Anthrax)
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 4

Summary: 
      A Phase IV, randomized, multicenter trial to assess the immunogenicity and safety of
      BioThrax® in varying dose regimens with the primary objective of obtaining information on
      possible dose-sparing strategies in the event of a major biothreat.
    

Detailed description: 
      This is a Phase IV, randomized, open-label immunogenicity and safety study to evaluate four
      dosing regimens of BioThrax® for Post-Exposure Prophylaxis (PEP) for anthrax. BioThrax® will
      be administered as a subcutaneous (SC) injection for the primary series and will be
      administered as an intramuscular (IM) injection for the boost. The four dosing regimens are:
      0.50mL BioThrax® on Days 0, 14, and 6 month boost; 0.50mL BioThrax® on Days 0, 28 and 6 month
      boost; 0.50mL BioThrax® on Days 0, 14, 28 and 6 month boost and 0.25mL BioThrax® on Days 0,
      14, and 28, 6 month boost with 0.50ml IM Approximately 300 subjects will be randomized
      1:1:1:1 to one of the four study arms. Enrollment will be stratified by gender, with
      approximately equal numbers of males and females (18 through 65 years) enrolled into each
      dosing regimen. The Primary objective is to evaluate the immunogenicity of the four dosing
      regimens of BioThrax® using the Toxin Neutralization Assay (TNA). The secondary objective is
      to evaluate the safety of the four dosing regimens of BioThrax®.
    

Intervention name(s): BioThrax®; BioThrax®
Intervention type(s): Biological; Biological
Intervention description(s): BioThrax® is a sterile, milky white suspension made from cell free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis, will be administered as a 0.50mL IM injection 6 month boost for all groups; BioThrax® will be administered as: Arm A: 0.50mL SC injection on Days 0 and 14; Arm B: 0.50mL SC injection on Days 0 and 28; Arm C: 0.50mL SC injection on Days 0, 14 and 28; Arm D: 0.25 mL SC injection on Days 0, 14 and 28.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bacillus anthracis, anthrax, vaccine, BioThrax®, dose-sparing
Enhancement of Physical and Combat Preparedness of SAF Members - Validation Study
Condition: Physical Fitness; Cardio Respiratory Fitness; Aerobic Capacity; Physical Examination; Combat Preparedness
Study type: Interventional

Summary: 
      The aim of the proposed project is to investigate the reliability, validity, and usefulness
      of the 30-15 intermittent fitness test in the Slovenian Armed Forces. We will compare the
      results obtained from a continuous treadmill running test, 2-mile run test, and 30-15IFT.
    

Detailed description: 
      Since the ability to perform military tasks depends on the physical fitness of soldiers (PF),
      one of the most commonly measured PF components during routine physical examinations is
      cardiorespiratory fitness (CRF). There are several tests used to measure CRF in the armed
      forces. Because of its simplicity, the most commonly used test of CRF is the 2-mile run test,
      but it has its own limitations when it comes to specificity of battlefield requirements,
      training prescription and optimization, and estimation of Vo2max. In combat situations,
      soldiers rarely run long distances on the battlefield. Therefore, the 2-mile run test does
      not appear to represent any specificity of combat. Furthermore, based on the data collected
      from this test, it is difficult to prescribe and optimize a training program for an
      individual subject. Therefore, the goal of the proposed project is to investigate the
      reliability, validity, and usefulness of the 30-15 intermittent fitness test in the Slovenian
      Armed Forces.
    

Intervention name(s): Cardio Respiratory Fitness testing
Intervention type(s): Diagnostic Test
Intervention description(s): In a randomized cross over designed study, we will measure Vo2max by using different tests:
Continous Treadmill Running Test
Continous 2-mile run test
30-15 Intermittent Fitness Test - first trial and second trial
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover randomized validation study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Low Back Pain
Condition: Non-specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The goal of this study is to enroll and randomize 99 participants with non-specific low back
      pain into a multimodal strategy of treatment consisting of a combination of dry needling (DN)
      and spinal manipulation therapy (SMT), DN only, and SMT only, followed by an at home exercise
      program. All groups will receive their respective treatment twice a week for 2 weeks followed
      by a 2-week home exercise program. Primary outcomes include clinical subjective (Oswestry
      Disability Index, numeric pain intensity rating) and mechanistic (lumbar multifidus, erector
      spinae, and gluteus medius muscle activation) measures assessed at baseline, 1, 2, and 4
      weeks. Timepoints at 2-weeks and 4-weeks will be compared to baseline measures to determine
      effectiveness of the combination group against the other single treatment groups. Exercise
      compliance will be measured by participants self-reporting adherence to the program by
      selecting average number of days per week the exercises are completed.
    


Intervention name(s): Spinal manipulation; Dry needling; Spinal manipulation and dry needling
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Spinal manipulation of the lumbar spine only to be performed in the spinal manipulation arm/group.; Dry needling of the lumbar erector spinae, multifidus, and gluteus medius on the symptomatic side performed in the dry needling arm/group.; The spinal manipulation and dry needling arm/group receive both spinal manipulation and dry needling as outlined in the other groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three groups of participants receive one of three different interventions. One group receives spinal manipulation only, another group receives dry needling only, and the last group receives the combination of spinal manipulation and dry needling. Participants in each group receive their respective treatment in parallel with the other groups.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back pain; Spinal manipulation; Dry needling; Diagnostic ultrasound; Oswestry disability index; Numeric pain rating scale
Totally Endoscopic Ablation of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Primary Objective To evaluate the efficiency of totally endoscopic ablation of AF compared to
      rate control management of AF.

      Secondary Objectives

      Does totally endoscopic ablation:

        -  reduce atrial fibrillation symptoms?

        -  increase working capacity and improve quality of life?

        -  improve atrial function?

        -  reduce the risk for stroke?
    

Detailed description: 
      This is a randomized open controlled single centre study that involves 60 patients (men and
      women) over the age of 50 years with longstanding persistent AF of more than one year
      duration and in the absence of other severe cardiopulmonary disease. One of the participating
      investigators informs the patient, both verbally and in writing, about the study and what
      participation in the study involves. The patient will be given time to ask questions and to
      consider study participation and can be enrolled in the study after signing and dating
      written Informed Consent. Study duration per patient is 12 months.

      After inclusion, the patient will be divided into one of two groups, treatment group or
      control group, according to block wise randomization. The patient will be asked to complete
      two health related questionnaires SF 36 and SCL and a transthoracic echocardiography will be
      conducted together with an exercise test.

      The patients will thereafter be assessed according to randomisation. Irrespective of group,
      the patients will be rescheduled for a visit within two months for totally endoscopic
      ablation and Reveal implantation or just Reveal implantation (control group). All patients
      will then be assessed during follow-ups after 1, 3, 6 and 12 months.
    

Intervention name(s): Endoscopic ablation of AF; Rate control
Intervention type(s): Procedure; Drug
Intervention description(s): The procedure is conducted in general anaesthesia. The right chest is entered with three working ports .
After a complete cycle of ablation creating a box lesion in the left atrium, conduction block is tested. A chest tube is placed through the most caudal port and the port incisions are closed. A Reveal loop recorder is then implanted subcutaneously. The patient is extubated and transferred to postoperative care.; Anti-arrhythmic protocol The control group is using a rate-control strategy. All patients keep their anti-arrhythmic/beta-blocker/digoxin medication during the entire follow-up. No attempts are made to rhythm-control the patients, unless subjective symptoms make it necessary.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial fibrillation; Ablation; Thoracoscopy; Atrial function
Continuing Cetuximab Plus Chemotherapy After First Progression in Wild-type KRAS, NRAS and BRAF V600E Metastatic Colorectal Cancer
Condition: Wild-type KRAS,NRAS and BRAF V600E Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study was to evaluate the efficacy and safety of continuing cetuximab
      combined with chemotherapy after first-line progression in wild-type KRAS,NRAS and BRAF
      colorectal cancer.
    

Detailed description: 
      In addition to the sequential therapeutic schedule of offering maintenance therapy and
      reintroduction of chemotherapy regimens to patients with nonresectable mCRC, multiline
      treatment strategy of continuing bevacizumab after progression to first-line bevacizumab plus
      chemotherapy demonstrated optimal clinical benefits in prolonging progression-free survival
      (PFS) and overall survival (OS) . Continuing cetuximab after progression to first-line
      cetuximab is also a promising strategy. The underlying hypothesis is that a sustained
      inhibition of EGFR signaling with cetuximab would continuously eliminate sensitive clones of
      RAS wild-type tumor. The present phase 2 clinical trial evaluated standard
      fluoropyrimidine-based chemotherapy combined with cetuximab among patients with wild-type
      KRAS, NRAS and BRAF V600E mCRC who had progressed after cetuximab plus standard chemotherapy
      in the first-line setting.
    

Intervention name(s): Cetuximab combind mFOLFOX6/FOLFIRI
Intervention type(s): Drug
Intervention description(s): Cetuximab 500mg/m2 ivgtt 2h d1 ,q14d;mFOLFOX6: Oxaliplatin 85mg/m2 ivgtt 2h d1, 5-Fu 400mg/m2 iv d1,Lefucovorin 400mg/m2 ivgtt 2h d1, 5-Fu 2.4/m2 CIV 46h, q14d; FOLFIRI: CPT-11 180mg/m2 ivgtt 60-90mins d1, 5-Fu 400mg/m2 iv d1,Lefucovorin 400mg/m2 ivgtt 2h d1,5-Fu 2.4/m2 CIV 46-48h, q14d
Intervention MeSH terms: Cetuximab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with metastatic colorectal cancer
A Study to Evaluate Efficacy and Safety Effects Using Mikelan® LA Ophthalmic Solution (OS) 2% Versus Timoptol® XE Ophthalmic Solution (OS) 0.5% in Ocular Hypertension Patients
Condition: Glaucoma
MeSH terms: Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the clinical study is to evaluate the efficacy and safety for
      Mikelan LA eye drops 2% (once per day) of intra-ocular pressure decreased.
    


Intervention name(s): carteolol (Mikelan), timolol (Timoptol), latanoprost (Xalatan)
Intervention type(s): Drug
Intervention description(s): Experimental: Mikelan, 1 drop/daily, for 8 weeks Active Comparator: Timoptol, 1 drop/daily, for 8 weeks
Intervention MeSH terms: Timolol; Carteolol; Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Fibromyalgia With Disease Activity and Clinical Findings in Women With Behçet's Disease
Condition: Behcet's Disease; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Behcet Syndrome
Study type: Observational [Patient Registry]

Summary: 
      In the literature, the relationship between fibromyalgia and disease activity has been
      assessed in a few studies without discrimination between women and men.In this study, it was
      aimed to evaluate the relationship between fibromyalgia and disease activity in women with
      Behçet's disease.
    

Detailed description: 
      There are only a few studies in the literature evaluating the association of fibromyalgia
      with disease activity and clinical findings in Behçet's disease. In the literature, the
      relationship between fibromyalgia and disease activity has been assessed without
      discrimination between women and men. Behçet's disease is more active in men and fibromyalgia
      is more frequent in women. Evaluating the relationship between fibromyalgia and disease
      activity in Behçet's disease without gender discrimination may not be objective.There is not
      any study in literature evaluating relationship between fibromyalgia and disease activity in
      women with Behçet's disease.In this study, it was aimed to evaluate the relationship between
      fibromyalgia and disease activity in women with Behçet's disease.
    

Intervention name(s): fibromyalgia 2013 criteria; Behcet's disease current activity form
Intervention type(s): Diagnostic Test; Other
Intervention description(s): Frequency of fibromyalgia will be investigated in women diagnosed with Behcet disease; Disease activity will be investigated in women with Behçet's disease without fibromyalgia.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women diagnosed with Behcet disease according to international study group criteria,
        between age 18-75, which are not pregnant and which were not previously diagnosed with
        diabetes mellitus or chronic renal failure.
      
Keywords: Behcet's disease; Fibromyalgia; Disease activity
Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4
      cardinal clinical features according to the International Restless Legs Syndrome Study Group
      (IRLSSG) are allowed to enroll in this trial.

      The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is
      efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to
      investigate the safety and tolerability of rotigotine.

      Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day
      rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be
      enrolled in this trial, participating at approximately 60 sites. The maximum duration of the
      trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month
      Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).
    


Intervention name(s): Rotigotine
Intervention type(s): Drug
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Idiopathic Restless Leg syndrome