bioihbjkbjnl/mcl2 huggingface dataset:
Rampart Duo Clinical (RaDical) Post-Market Study
Condition: Lumbar Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational [Patient Registry]

Summary: 
      This exempt, minimal risk, prospective, post-market, registry, multi-center, Institution
      Review Board (IRB) approved observational clinical evaluation was conducted at 10 centers. A
      total of 197 patients were enrolled. The evaluation collected data in a real-world patient
      population and was a data collection initiative only. No patient treatments or care were
      performed as a component of the protocol. All patient care received was on-label and standard
      of care for lateral lumbar interbody fusions. The data collected in this evaluation is
      intended to contribute to the body of literature for lateral lumbar interbody fusions.
    

Detailed description: 
      The purpose of this study was to collect data that reports on the clinical outcomes of
      patients that were treated with the Spineology Rampart DUO device in a standard of care
      instrumented lateral lumbar interbody fusion procedure at one or two contiguous levels from
      L2-L5. Data was collected prospectively at specified time points per protocol and included
      both objective and subjective measures. The study concluded when the final patient achieved
      their 12-month evaluation.
    

Intervention name(s): In this evaluation, no interventions are performed. It is a data collection effort only. The "procedure" for this study is the data collection effort.
Intervention type(s): Other
Intervention description(s): There is no intervention performed in this evaluation. Data is being collected in an on-label standard of care lateral lumbar interbody fusion procedure.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Real-world population consistent with cleared labeling for the product.
Efficacy of Wet Cupping on Reactive Oxygen Species and Antioxidants
Condition: Healthy
Study type: Interventional

Summary: 
      This study evaluates the efficacy of Wet cupping Therapy on oxidative stress and antioxidant
      capacity of the body.The healthy volunteers will receive wet cupping application and their
      initial venous blood samples and samples after the treatment will be evaluated for oxidative
      stress.
    

Detailed description: 
      Among the healthy individuals who applied for Wet Cupping Therapy (WCT) to Traditional and
      Complementary Therapies center in Karabuk Medical Faculty Education and Research Hospital for
      general wellbeing 24 volunteers were enrolled in the study. They will receive three
      concecutive WCT application in one month interval.Their venous blood samples obtained
      initially and after the completion of the three concecutive applications, will be evaluted in
      terms of Reactive Oxygen species and Antioxidant capacity.Additionally samples from the
      cupping blood during the first and the third WCT application will also be obtained and
      evaluated.
    

Intervention name(s): Wet Cupping
Intervention type(s): Procedure
Intervention description(s): CT was applied using plastic disposable vacuum cups on the back in the 5 areas of C7 cervical spine (DU14 acupoint), T2-4 lateral spine bilaterally (BL41-42 acupoint) and T6-8 lateral spine bilaterally (BL44-46), which are the recommended sites for headache (12). The cupping technique procedure was conducted in five phases:Primary suction,Area disinfection,Scarification,Secondary suction and bloodletting,Removing and dressing.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wet cupping therapy; antioxidant capacity
Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)
Condition: PCV; Polypoidal Choroidal Vasculopathy
MeSH terms: Polypoidal Choroidal Vasculopathy; Vascular Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal
      choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.
    


Intervention name(s): high-dose ranibizumab; ranibizumab
Intervention type(s): Drug; Drug
Intervention description(s): 20mg ranibizumab vials, 0.05ml injected intravitreally, monthly; 3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
Other intervention name(s): Lucentis
Intervention MeSH terms: Ranibizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PEARL2; PCV; Polypoidal Choroidal Vasculopathy
Investigation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of Oral Danirixin in Symptomatic COPD Subjects With Mild to Moderate Airflow Limitation at Risk for Exacerbations
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this First Time in Patient study is to obtain initial information on the safety,
      tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of repeat daily
      administration of danirixin in subjects with symptomatic chronic obstructive pulmonary
      disease (COPD) having mild to moderate airflow limitation and are at high risk for future
      COPD exacerbations.

      The study will be conducted in two parts. Part A will be a two week open label, single arm
      study in patients with COPD to obtain pharmacokinetic data and safety information of repeat
      dosing of danirixin in the population of interest. Approximately 10 subjects will be enrolled
      in Part A of the study. Progression to and dose selection for Part B will occur following
      review of the data collected in Part A. Part B will be a 52-week, randomized, double-blind
      (sponsor unblind), placebo-controlled on top of standard of care, parallel group study. Part
      B will evaluate several clinical efficacy assessments related to exacerbations and
      respiratory symptoms. Approximately 100 subjects will be enrolled with a target of 80
      subjects completing 52 weeks of danirixin administration.
    


Intervention name(s): Danirixin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Danirixin is available as 50 or 75 mg white, film coated immediate release tablet.; Subjects will receive danirixin matching placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Efficacy; Danirixin; EXACT-PRO; COPD; Safety; RD; CXCR2 inhibitor; EXACT-RS; PK; HCRU exacerbations; PD
The Effects of Caffeine on Pain-Based Pacing During a Cycling Time-Trial
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Caffeine has been shown to consistently improve time-trial performance, warranting
      restrictions on consumption under regulation of the National Collegiate Athletics Association
      (NCAA) and World Anti-Doping Agency (WADA). This ergogenic effect is not well understood,
      possibly occurring as a result of altered metabolism, improved strength, and/or reduced
      muscle pain. The hypothesis of altered metabolism has recently fallen out of favor while
      muscular strength has a tenuous relationship with endurance exercise performance. Reductions
      in muscle pain have been observed during low and moderate intensity endurance exercise, and
      this may be the mechanism of caffeine's ergogenic effect. In lieu of reducing pain during
      high intensity exercise, caffeine significantly improves performance. Therefore, caffeine
      appears to improve the amount of work that can be done for a given muscle pain rating,
      suggesting that participants may pace based upon sensations of muscle pain during endurance
      exercise. Most time-trial exercise is conducted in a fixed distance manner, measuring the
      time it takes participants to cover a given distance. Little research has been conducted on a
      fixed pain time-trial that would require participants to produce and sustain a given level of
      muscle pain while measuring the distance covered in an allotted time. A fixed pain time-trial
      could allow researchers to better understand the effect of pain on endurance performance. The
      purpose of this study is to examine the effects of caffeine on a fixed pain time-trial.
    


Intervention name(s): Caffeine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Caffeine
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: physically active,; 18-35 year old men
A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional

Summary: 
      This is a randomized, double-blind pilot clinical trial to test a novel treatment approach to
      rehabilitate fine motor function in individuals living with progressive multiple sclerosis
      (MS) using anodal transcranial direct current stimulation (tDCS) to augment manual dexterity
      training. Treatment will be delivered to individuals at home using a state-of-the-art
      remotely supervised tele-rehabilitation protocol, a major advantage for patients with respect
      to ease of access, feasibility, reinforcement learning and minimal burden of in clinic study
      visit participation. Improvements in fine motor skill will be assessed at each remote session
      using a novel portable grip device that measures execution and adaptation or learning of
      fingertip forces during grasp, which is more sensitive than standard measures of hand
      function.
    


Intervention name(s): Active RS-tDCS +At-Home Manual Dexterity Training; Sham RS-tDCS +At-Home Manual Dexterity Training; Manual dexterity training
Intervention type(s): Device; Device; Other
Intervention description(s): Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes; Designed to ensure blinding, includes initial and ending "ramp-up/down" stimulation for 60 seconds; Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Anodal transcranial stimulation (tDCS)
A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects
Condition: Growth Disorder; Healthy
MeSH terms: Growth Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The aim of the trial is to
      investigate the bioequivalence (the expected biological equivalence of two pharmaceutical
      drug products with identical active ingredient) of Norditropin® (somatropin) versus
      Genotropin® (somatropin) in healthy adult subjects.
    


Intervention name(s): Norditropin® FlexPro® pen; Genotropin Pen®
Intervention type(s): Drug; Drug
Intervention description(s): Administered as a single subcutaneous (s.c., under the skin) dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.; Administered as a single subcutaneous dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single and Multiple Ascending Doses Clinical Pharmacology Study With KAR5585
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability, pharmacokinetics (PK), cardiac conduction and food effect study on
      single and multiple ascending doses of KAR5585 in healthy adults.
    

Detailed description: 
      The purpose of this study is to explore the safety, tolerability, pharmacokinetics (PK), and
      cardiac conduction effects of single and multiple ascending doses of KAR5585 in healthy
      adults. Food effect will also be evaluated after a single-dose administration.
    

Intervention name(s): KAR5585 Capsules; Placebo Capsules
Intervention type(s): Drug; Drug
Intervention description(s): Single and multiple ascending doses of KAR5585 (100 mg initial dose); Single and multiple ascending doses of placebo (100 mg initial dose)
Other intervention name(s): KAR5585
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Serotonin; Pulmonary Arterial Hypertension; Pharmacokinetics; Phase 1; Healthy Volunteers
Bioavailability Study of SYN006, Pulmicort pMDI and Meptin Air in Healthy Adult.
Condition: Asthma; Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Budesonide + Procaterol HFA MDI is a novel asthma product containing both budesonide and
      procaterol in a single inhaler. Budesonide is a corticosteroid that treats underlying airway
      inflammation in asthma. Procaterol is a direct acting sympathomimetic with predominantly
      Beta-adrenoceptor stimulant activity selective to Beta-2 receptors (a Beta-2 agonist). It is
      used as a bronchodilator in the management of reversible airways obstructive pulmonary
      disease. Budesonide and Procaterol therefore have complementary effects, treating two
      different components of asthma.
    

Detailed description: 
      Test drug : SYN006 HFA MDI (Budesonide + Procaterol Hydrochloride) Strength: (Budesonide
      180ug and Procaterol Hydrochloride 10ug/puff) Mode of administration: Orally inhaled
      administration, single dose (4 puffs)

      Reference drug 1 : Pulmicort pMDI (Budesonide) Strength: (Budesonide 200ug/puff) Mode of
      administration: Orally inhaled administration, single dose (4 puffs)

      Reference drug 2 : Meptin Air 10ug (Procaterol Hydrochloride) Strength: (Procaterol
      Hydrochloride 10ug/puff) Mode of administration: Orally inhaled administration, single dose
      (4 puffs)

      One dose for each drug (Test, Reference 1 and Reference 2)with an at least 6-day washout
      period.
    

Intervention name(s): Budesonide; Procaterol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Budesonide; Procaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relationship Between Symptoms, Retinal Morphology, and the Nigrostriatal Dopamine System in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this study is to examine if a correlation exists between findings from brain
      imaging studies of the status of the dopamine system in the brain using DaTscan and SPECT
      imaging, clinical symptoms of Parkinson's disease, and changes in the structure of the retina
      as detected by optical coherence tomography (OCT) in recently diagnosed and more advanced
      Parkinson's disease patients.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be Parkinson's disease patients (Hoehn and Yahr stage 1 - 3). One
        study group will be subjects (N = 6) with early PD who will be within 3 years from
        diagnosis and not requiring dopaminergic therapy. These subjects will need to have Unified
        Parkinson's Disease Rating Scale motor scores of 10 - 15. The second study group will be
        subjects (N = 6) with more advanced PD and will have had PD for at least 5 years and will
        need to have Unified Parkinson's Disease Rating Scale motor scores of > 20.
Use of Dexmedetomidine in Children Undergoing Cardiac Surgery
Condition: Deep Sedation
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to evaluate the efficacy of dexmedetomidine in reducing the need for
      sedatives and analgesics in the immediate post-operative period in children who underwent
      surgical correction of complex congenital heart disease
    

Detailed description: 
      The hypothesis the investigators want to verify is that the reduced administration of
      sedative drugs (opioids and benzodiazepines) in children undergoing cardiac surgery, reduces
      the side effects of the drugs themselves, such as respiratory depression (reduction of
      mechanical ventilation) and the onset of withdrawal symptoms while maintaining an adequate
      analgo-sedation.

      The study is an unblinded randomized controlled study. It will involve 60 children aged > 1
      and < 24 months sedated and mechanically ventilated after corrective or palliative surgery of
      congenital heart disease on cardiopulmonary bypass with Aristotle score > 8.

      Dexmedetomidine infusion will be started upon arrival in the CICU and continued until the
      time of discontinuation of morphine.
    

Intervention name(s): dexmedetomidine
Intervention type(s): Drug
Intervention description(s): dexmedetomidine continous infusion 0.5 mcg/kg/h
Other intervention name(s): dexdor
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of AC-201 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 24-week randomized placebo-controlled study to investigate the effect of an oral
      IL-1beta inhibitor AC-201 in patients with type 2 diabetes mellitus already treated on
      different background diabetes therapies.
    


Intervention name(s): AC-201, 25mg; AC-201, 50mg; AC-201, 75mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsule, 25mg BID; Capsule, 50mg BID; Capsule, 75mg BID; Placebo BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: AC-201; Interleukin 1 inhibitor
Score System for Prediction Risk and Early Diagnosis of HCC in HIV/HCV Patients
Condition: Acquired Immunodeficiency Syndrome Virus; Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted; Hepatocellular Carcinoma
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Carcinoma; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      The aim of this study is to establish a clinical score panel based on clinical, molecular and
      genetic parameters that allow us to stratify and obtain an early detection of patients with
      an increased risk of developing hepatocellular carcinoma (HCC).
    

Detailed description: 
      Transversal study design like a "proof of concept".

      Primary objective:

      The main objective is try to stablish a descriptive panel (first phase of a score system)
      based in the conjunction or sum of several clinical and laboratory parameters (molecular and
      genetic factors). The aim is to detect in a fast, early and successful way those patients
      that presents a high risk to develop an hepatocellular carcinoma (HCC) in the future in a
      specific population: HIV and HCV coinfected patients. The establishment of this panel will
      allow clinicians set up a correct treatment decreasing the probability of liver cirrhosis and
      HCC.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        HIV/HCV coinfected patients from Infectious Diseases Department
      
Biospecimen description: 
      Serum, plasma, white cells
Dose-effect of SSR180575 in Diabetic Neuropathy
Condition: Diabetic Neuropathies
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this sudy is to assess the effect of two doses of SSR180575 on the
      rate of regeneration of epidermal nerve fibers following denervation of the epidermal layer
      with capsaicin in patients with diabetes mellitus and mild peripheral neuropathy. Secondary
      objectives are to explore the efficacy of SSR180575 on clinical assessment, nerve function
      measures and to assess the tolerability and safety of SSR180575. The treatment period is 6
      months.
    


Intervention name(s): SSR180575; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral, once daily dosing; Oral, once daily dosing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Neuropathy
Patients With Distal Radius Fracture
Condition: Physical Disability
MeSH terms: Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      Surgically and conservatively treated distal radius fractures followed for six month. In this
      period 12 weeks rehabilitation programme applied for each group. Nine different evaluations
      were done in the initial, after physical therapy and 6th month. Results were presented.
    

Detailed description: 
      Distal radius fracture (DRF) affects overall health status. The International Classification
      of Function (ICF) based approach is appropriate in the management of DRF. The purpose of this
      study was to investigate functional status and activity participation levels of DRF patients.

      The patients were divided into conservative and surgical groups and were admitted to 12-weeks
      rehabilitation period. The evaluation of the body function and structure were done with
      Visual Analogue Scale, algometer, range of motion (ROM) and grip strength. Also, radiographic
      evaluations were done. Activity participation assessments were done with Push-Off Test (POT),
      Michigan Hand Outcomes Questionnaire (MHOQ), Short Form of Disabilities of Arm-Shoulder and
      Hand Questionnaire (Q-DASH) and Jebsen-Taylor Hand Function Test (JTHFT). Mann-Whitney U and
      Wilcoxon Tests were used respectively for intergroup and intra-group comparisons. Statistical
      significance level was p<0,05.
    

Intervention name(s): 12 weeks physical therapy programme
Intervention type(s): Other
Intervention description(s): The programme include contrast bath, bandage, massage, active exercises, resistive exercises.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Distal radius fracture; functional status; activity participation; hand therapy