bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of the SRD part of this trial are to investigate safety, tolerability,
      pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1356225 in healthy male subjects
      following oral administration of single rising doses. The main objective of the BA part of
      this trial will be to explore the influence of food on the bioavailability of tablet fasted
      versus tablet fed
    


Intervention name(s): BI 1356225; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Dose; Oral dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Therapeutic Efficacy Between Intralesional Bleomycin and Cryotherapy in Plantar Warts
Condition: Viral Wart
MeSH terms: Warts
Study type: Interventional

Summary: 
      A randomized control trial to compare the efficacy difference between intralesional bleomycin
      and cryotherapy in treating plantar warts.
    

Detailed description: 
      In spite of many available studies on bleomycin and cryotherapy in treating warts, little
      head-to-head research is carried out to compare the efficacy of these treatments. This study
      shows clear difference in the clearance of warts treated with intralesional bleomycin and
      cryotherapy.
    

Intervention name(s): COMPARISON OF THERAPEUTIC EFFICACY BETWEEN INTRALESIONAL BLEOMYCIN AND CRYOTHERAPY IN PLANTAR WARTS
Intervention type(s): Procedure
Intervention description(s): comparison of therapeutic efficacy between intralesional bleomycin and cryotherapy in plantar warts
Intervention MeSH terms: Bleomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Control Trial (RCT)
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional

Summary: 
      The aim of this study will be to investigate the effect of aerobic exercise on diurnal
      cortisol pattern in premenstrual syndrome.
    

Detailed description: 
      Premenstrual syndrome is manifested by recurrent emotional and depressive symptoms that may
      be associated with maladaptive coping with stress situations and the enhanced release of
      stress hormones, like cortisol hormone. Although previous studies revealed a flattened
      diurnal cortisol slope in women with PMS compared to healthy controls, there is no previous
      work on the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome.
      Therefore, this study will aim to investigate the effect of aerobic exercise participation on
      diurnal cortisol pattern in premenstrual syndrome.This trial will include two groups; group
      (A) will consist of 14 females who will receive relaxation training for 8 weeks, while group
      (B) will consist of 14 females who will receive the same relaxation training along with
      aerobic exercise for 8 weeks.
    

Intervention name(s): Relaxation training; An aerobic exercise program
Intervention type(s): Other; Other
Intervention description(s): Relaxation training in the form of deep breathing exercises; An aerobic exercise program of a moderate intensity, based on the target heart rate (THR) that will be calculated in accordance with Karvonen's equation, using resting heart rate (HRrest), maximal heart rate (HRmax) and training fraction. THR = HRrest (bpm) + (HRmax (bpm) - HRrest (bpm)) × training fraction.The exercise session will have three phases, warming up, active phase and cooling down.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aerobic exercise; Relaxation training; Diurnal cortisol pattern; Premenstrual syndrome
Neuromuscular Electrical Stimulation Following Total Hip Arthroplasty
Condition: Deep Vein Thrombosis; Total Hip Arthroplasty
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      Patients post total hip arthroplasty (THA) remain at high risk of developing Deep Vein
      Thrombosis (DVT) during the recovery period following surgery despite the availability of
      effective pharmacological and mechanical prophylactic methods. The use of calf muscle
      neuromuscular electrical stimulation (NMES) during the hospitalised recovery period on this
      patient group may be effective at preventing DVT. However, the haemodynamic effectiveness and
      comfort characteristics of NMES in post-THA patients immediately following surgery have yet
      to be established.

      The main objectives are:

        1. To establish if patients in the early post-operative period have tolerance for NMES.

        2. To determine if applying NMES to patients immediately post-THA increases venous outflow
           from the lower limb over resting conditions.
    


Intervention name(s): Neuromuscular Electrical Stimulation
Intervention type(s): Device
Intervention description(s): Applied using a custom built, medically approved stimulator called the Duo-STIM. NMES to be applied to the calf muscles to elicit a muscular contraction to eject blood through the venous system.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Neuromuscular electrical stimulation; NMES; Deep vein thrombosis; DVT; total hip arthroplasty; lower limb hemodynamics
Applicability Clinic of Cement Portland Structural White in Endodontic Surgery
Condition: Mandibular Hypoplasia
MeSH terms: Micrognathism
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Thirty teeth twelve patients, two female and a male, who had persistent periradicular lesions
      were selected to participate in this study. The lesions were diagnosed with cone-beam
      computed tomography (cone-beam CT; Model i-Cat 17-19, Imaging Sciences International LLC).In
      patients with two teeth to be treated, a tooth was retroobturado with PBEA cement,
      (experiment) and another tooth was retroobturado with MTA cement (control).

      There was significance for the two cements on the repair of wounds. Key words: Apicoectomy;
      Oral Surgery; Biocompatible Materials; Dental Cements; Translational Medical Research
    

Detailed description: 
      Objective: to evaluate the clinical applicability of structural Portland white cement
      additive in retrofilling surgeries. Method: persistent apical periodontitis 30 teeth of 12
      patients were diagnosed by computed tomography CT, cone beam. Each of them had from two to
      four compromised teeth. The endodontic surgery were performed and the teeth were retrofilling
      Each patient had a retrofilling tooth with cement mineral trioxide aggregate (MTA) control
      and other tooth with white Portland cement structural additive (PBEA) experiment. When the
      patient presented four teeth with injury, two were retrofilling with MTA and two Portland
      cement with structural white cement additive. Six months after surgery, there were new scans
      to evaluate the repair or not the wounds.
    

Intervention name(s): ENDODONTIC SURGERY
Intervention type(s): Procedure
Intervention description(s): ENDODONTIC SURGERY
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Apicoectomy; Oral surgery; Biocompatible materials; Dental Cements; Translational Medical Research
Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
Condition: Motion Sickness
MeSH terms: Motion Sickness
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the
      treatment of motion sickness.
    


Intervention name(s): Tradipitant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SERETIDE Plus Tiotropium Versus Individual Components
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to evaluate the effects on lung function of a combination of SERETIDE
      50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual
      treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily
      alone) in subjects with COPD. The study will utilise a three-way cross-over design with a
      2-week wash-out period between each 2-week consecutive treatment period.
    

Detailed description: 
      A randomised, double-blind, double dummy, 3 way cross-over study evaluating the effects of
      SERETIDE™ 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the
      individual treatments (tiotropium bromide 18mcg alone and SERETIDE 50/500mcg alone) in the
      treatment of subjects with COPD
    

Intervention name(s): Tiotropium + SERETIDE 50/500
Intervention type(s): Drug
Intervention MeSH terms: Tiotropium Bromide; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cross-over; Tiotropium; Triple; COPD; SERETIDE 50/500; Dyspnoea; Impulse oscillometry; Plethysmography
Does Perineural Dexamethasone Increase the Duration of an Ulnar Nerve Block When Controlling for Systemic Effects?
Condition: Anesthesia, Local
Study type: Interventional
Phase: Phase 2

Summary: 
      Investigators will assess if perineural dexamethasone can increase the duration of an ulnar
      nerve block when controlling for systemic effects in healthy volunteers.
    

Detailed description: 
      Healthy volunteers will have bilateral ulnar nerve blocks performed with bupivacaine on two
      different days with a minimum of 14 days wash-out. On one day, the participants will also
      receive dexamethasone in one arm and placebo in the other. On the other day, the participants
      will also receive placebo in one arm and lidocaine in the other. By this using this design,
      the investigators will be able to assess if perineural dexamethasone can increase the
      duration of an ulnar nerve block when controlling for the systemic effects. Furthermore, to
      ensure blinding, the investigators have also incorporated the lidocaine group which also
      allows for the assessment of the effects of adding lidocaine to a peripheral nerve block with
      bupivacaine. The order of which the participant will receive dexamethasone and lidocaine will
      be random. It will also be random in which arm the participant receives dexamethasone and
      lidocaine.
    

Intervention name(s): Perineural dexamethasone; Lidocaine; Placebo; Systemic dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dexamethasone 4mg will be added perineurally to an ulnar nerve block with bupivacaine.; Lidocaine 40 mg will be added perineurally to an ulnar nerve block with bupivacaine.; Saline will be added perineurally to an ulnar nerve block with bupivacaine.; Dexamethasone will be added perineurally to an ulnar nerve block with bupivacaine, some will be reabsorbed and distributed systemically. Thereby, the investigators control for the systemic effects of adding perineural dexamethasone to an ulnar nerve block.
Other intervention name(s): Saline
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lidocaine; BB 1101
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised, blinded, placebo-controlled, paired, non-inferiority trial in healthy volunteers.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Regional anesthesia; Dexamethasone; Peripheral nerve block
An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine
Condition: Migraine Disorder
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine
    


Intervention name(s): ALD403 (Eptinezumab)
Intervention type(s): Biological
Other intervention name(s): Eptinezumab-jjmr; Vyepti
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Observational

Summary: 
      This retrospective study will assess the sustained virologic response and the safety of two
      different interferons (pegylated or conventional) in patients with chronic hepatitis C. Data
      will be collected for 24 weeks.
    


Intervention name(s): Conventional Interferon; Peginterferon Alfa-2a; Peginterferon Alfa-2b; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Conventional interferon according to the standard of care and aligned with the local prescription instructions; Peginterferon alfa-2a according to the standard of care and aligned with the local prescription instructions; Peginterferon alfa-2b according to the standard of care and aligned with the local prescription instructions; Ribavirin according to the standard of care and aligned with the local prescription instructions
Intervention MeSH terms: Interferons; Ribavirin; Peginterferon alfa-2a; Peginterferon alfa-2b
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hepatitis C patients that received interferon (pegylated or conventional) during the period
        stipulated (from 01-Sep-2007 to 31-Aug-2008)
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics,
      safety and tolerability of HIP1801 in healthy male subjects.
    


Intervention name(s): HIP1402; HIP1801
Intervention type(s): Drug; Drug
Intervention description(s): Tamsulosin (HanmiTams Capsule) 0.4mg; Tamsulosin 0.4mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Adoptive Immunotherapy in Relapsed and Non-resectable Sarcomas After Multimodal Treatment.
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Monocentric, phase I study for advanced sarcoma with adoptive immunotherapy with
      Cytokine-Induced Killer (CIK).

      In the first part of the study Patient's' peripheral blood will be collected and CIK cell
      expansion and storage will occur at the Regina Margherita Children's Hospital Cell Factory.

      In the second part of the study the Maximum Tolerated Dose (MTD) will be determined in order
      to find the Recommended Dose for Phase II (RP2D)
    


Intervention name(s): Autologous CIK
Intervention type(s): Drug
Intervention description(s): Lymphocytapheresis of the autologous ex-vivo CIK cell expanded in the Cell factory (4 dose levels)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of the Safety and Efficacy of Renzapride in Constipation Predominant Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate whether renzapride will help alleviate the
      symptoms associated with constipation predominant irritable bowel syndrome in female
      patients.
    

Detailed description: 
      Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by
      recurrent symptoms of abdominal pain/discomfort accompanied by disturbed bowel function.

      In this study female patients with constipation predominant IBS will receive one of two
      dosing regimens of renzapride or placebo for 12 weeks. Patients will record the severity of
      their symptoms throughout the study. The results will be analysed to see if those patients
      who received renzapride had greater relief of their symptoms than did the patients who
      received placebo.
    

Intervention name(s): Renzapride
Intervention type(s): Drug
Intervention description(s): Placebo Renzapride 4 mg QD Renzapride 2 mg BID
Other intervention name(s): ATL-1251; BRL-24924
Intervention MeSH terms: Renzapride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable bowel syndrome; Constipation-predominant irritable bowel syndrome
The Oxidative Stress, Inflammatory Markers, and Metabolomics Response to Exercise in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The effect of different physical exercise protocols on inflammatory markers, antioxidant
      balance, and metabolomics has not been fully elucidated. Therefore, the purpose of this study
      is to investigate the responses of oxidative stress, inflammatory markers, and metabolomics
      to exercise.
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD), one of the major causes of morbidity and
      mortality, is a preventable and curable disease characterized by irreversible airflow
      limitation. The progressive lung involvement, systemic inflammation, respiratory and
      peripheral muscle dysfunction, loss of muscle mass, and the dysfunction of the remaining
      muscles occur in COPD. Muscle dysfunction, which is defined as loss of strength or loss of
      endurance characteristics in muscles, is a comorbidity associated with poor outcomes such as
      frequent hospitalization and decreased survival, as well as adversely affecting exercise
      capacity and quality of life. Exercise increases mitochondrial activity and requires
      antioxidant defense to achieve cellular redox regulation. The effect of different physical
      exercise protocols on inflammatory markers, antioxidant balance, and metabolomics has not
      been fully elucidated. Oxidative stress, inflammatory markers, and metabolic responses to
      different acute exercise modalities in COPD patients need to be examined and clarified.
      Therefore, the purpose of this study is to investigate the responses of oxidative stress,
      inflammatory markers, and metabolomics to exercise. Detection of biomolecules that change
      with acute exercise may also contribute to the identification of exercise-related pathways.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Same participants will undergo different one bout of exercise protocols
Intervention model: Single Group Assignment
Intervention model description: Same participants will undergo two different exercise protocols after maximal exercise test.
Masking: None (Open Label)
Primary purpose: Basic Science
Demodex Blepharitis Treatment Study
Condition: Chronic Blepharitis
MeSH terms: Blepharitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized clinical trial to determine the safety and efficacy of terpinen-4-ol
      (T4O), the most active ingredient of tea tree oil (TTO), in eradicating ocular demodicosis
      (reducing ocular demodex counts and achieving the clinical improvement with minimal or no
      irritation).
    

Detailed description: 
      Demodex blepharitis is one of the most common causes of chronic blepharitis. The
      investigators preliminary clinical study showed that lid scrub with TTO was effective in
      resolving chronic blepharoconjunctivitis; however, it was not convenient for
      self-administration and caused irritation in some patients. Preclinical safety studies have
      verified that T4O is less irritant. In this study, the investigators will determine the
      optimal regimen of T4O Pads.
    

Intervention name(s): Terpinen-4-ol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Lid scrub once or twice per day for one month.; Lid scrub once or twice per day for one month
Other intervention name(s): T4O
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blepharitis; Demodex; Mites; Tea Tree oil; Terpinen
COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes
Condition: Type 2 Diabetes Mellitus; Diabetes-related Distress; Depression
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The study will implement and evaluate, using a pragmatic comparative effectiveness trial, a
      unique collaborative, stepped-care intervention for patients with uncontrolled Type 2
      diabetes and co-morbid distress and/or depression.
    

Detailed description: 
      The investigators plan to implement and evaluate, using a pragmatic comparative effectiveness
      trial, a unique collaborative, stepped-care intervention for patients with uncontrolled Type
      2 diabetes and co-morbid distress and/or depression. The investigators approach will combine
      practice-based medical and cognitive behavioral treatment with strong community-based support
      to immediately place the patient at the right level of intervention based on disease and
      severity and to step-up treatment intensity and follow-up if the initial response is
      inadequate. The practice-based component will use a care manager linked to medical,
      pharmacologic, and behavioral colleagues. The community based component will utilize
      community health workers to provide support and facilitate access to resources. Goals
      include: 1) implementing and evaluating the effectiveness of this intervention; 2) examining
      the impact of this approach on psychological mediators of improved glycosylated hemoglobin
      (HbA1c); and 3) building, sustaining, and disseminating a cost-effective care model.
    

Intervention name(s): Integrated Behavioral Care
Intervention type(s): Behavioral
Intervention description(s): Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment