bioihbjkbjnl/mcl2 huggingface dataset:
An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C
      Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is,
      pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with
      antiretroviral therapy) participants.
    

Detailed description: 
      This is a Phase 2a, partially-blind, randomized (study drug assigned by chance) and
      multiple-dose study to evaluate the activity and safety of telaprevir on HCV early viral
      kinetics in treatment-naive participants who are chronically infected with HCV Genotype 4.
      The study consists of 4 parts: Screening period (6-week); Investigational Treatment period
      (consisting of 2-week treatment with telaprevir or telaprevir+standard treatment or placebo);
      Standard Treatment period (consists of 46 or 48-week standard treatment); and Follow-up
      period (24-week). The activity of telaprevir will be evaluated by early viral kinetic
      parameters along with viral response and pharmacokinetic assessments during the
      investigational treatment phase. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Telaprevir; Pegylated-interferon-alfa-2a; Placebo; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.; Pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.; Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks.; Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C; Telaprevir; Pegylated-interferon-alfa-2a; Pegasys; Ribavirin; Copegus
Rhythmical Massage Compared With Heart Rate Variability Biofeedback in Women With Menstrual Pain (Dysmenorrhea)
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      A study to explore whether rhythmical massage and heart rate variability biofeedback can help
      to reduce pain in women suffering from menstrual pain (dysmenorrhea).
    

Detailed description: 
      This is a three-arm randomized controlled trial to evaluate the efficacy of rhythmical
      massage and HRV biofeedback in women with primary dysmenorrhea compared to a control group.
      The main focus is on pain intensity during menstruation. Moreover, analgesics intake, SF-12
      mental and physical scores and parameters of a 24h-HRV measurement are assessed before and
      after the three-month intervention.
    

Intervention name(s): Rhythmical massage; HRV biofeedback
Intervention type(s): Other; Behavioral
Intervention description(s): Rhythmical Massage according to Dr Ita Wegman, derived from Swedish Massage in the 1920s. Applied for various indications in the context of Anthroposophic Medicine, aiming at a recovery of self-regulation and self-healing forces.; One of various biofeedback types, HRV biofeedback gives a visual feedback of the participant's heart rate variability as an indicator for general health, physical and cognitive performance, self-regulation and a decreased risk of illness.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized to one of the three groups (rhythmical massage, HRV biofeedback or control). After the three-month intervention period, the controls receive rhythmical massage for ethical and compliance reasons. Assessments are taken before and after the intervention phase. Pain intensity is once more queried three months after the end of the intervention period.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dysmenorrhea; Women Health; Rhythmical Massage; Anthroposophic Medicine; HRV Biofeedback
Clinical Applicability of the Device Belk in the Rehabilitation Process
Condition: Application Site Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      Pilot, interventional, randomized of parallel groups and multicenter clinical trial.
    


Intervention name(s): Belk Device; Standard Rehabilitative treatment
Intervention type(s): Device; Other
Intervention description(s): Knee exoskeleton with electrostimulation; Use the standard rehabilitative treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations
      of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol
      fumarate, all administered BID in patients with stable, moderate to severe COPD.

      Every treatment period is 14-days long and there is a 7-days wash-out period in between them.
      The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow
      up contact 14-days after last treatment dose.
    


Intervention name(s): Aclidinium 200 μg / formoterol 12 μg; Placebo; Formoterol 12 μg; Aclidinium 200 μg; Aclidinium 200 μg / Formoterol 6 μg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily; Placebo control twice daily; Formoterol fumarate 12 μg twice daily; Aclidinium bromide 200 μg twice daily; Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bronchitis; Chronic; Emphysema
Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index
Condition: Psoriasis; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Study type: Observational

Summary: 
      The object of this research study is to examine these associations in children as very little
      is known about psoriasis and cardiovascular risk factors in the pediatric population.
    

Detailed description: 
      Several environmental factors and comorbid conditions have been found to be associated with
      psoriasis in adults, including obesity, depression, smoking, and other cardiovascular risk
      factors such as high blood pressure. The object of this research study is to examine these
      associations in children as very little is known about psoriasis and cardiovascular risk
      factors in the pediatric population.

      This is a multi-center study with a planned total enrollment of about 200 subjects ages 2-17
      years old with psoriasis and 100 aged-match controls. Patient and family history will be
      recorded. All subjects will undergo standard height, weight, blood pressure, and waist
      circumference (WC). For the obese and overweight subjects we will also obtain their growth
      charts to attempt to correlate weight gain with psoriasis onset and progression. All data
      will be compiled and then statistically analyzed.
    

Intervention name(s): Blood pressure; Height; Weight; BMI; Waist Circumference
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Blood pressure will be measured once while patient is seated; Height will be measured in centimeters at the time of enrollment; Weight will be measured in kilograms at enrollment; Body Mass Index (BMI) will be calculated from a subject's height and weight; Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest with an inelastic measuring tape at the end of normal expiration to the nearest 0.1cm
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        1. Children ages 5 to 17 years old with either moderate or severe plaque type psoriasis

          2. Children ages 5 to 17 years old with moderate or severe atopic dermatitis

          3. Children ages 5 to 17 years old seen in dermatology clinic who are healthy and without
             a systemic disorder.
      
Keywords: Psoriasis; Obesity; BMI; Atopic Dermatitis
Analgesia by Single or Dual Acupoints Stimulation After Radical Mastectomy
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of dual acupoints and single acupoint
      transcutaneous electrical acupoint stimulation (TEAS) pretreatment on incidence of
      Post-Mastectomy Pain Syndrome(PMPS) in patients undergoing operation of breast cancer.
    

Detailed description: 
      Patients were randomly assigned to three groups, receiving 30min TEAS before anesthesia
      respectively. The acupoints of dual point group are bilateral Neiguan points(PC6) combined
      with Danzhong point(RN17), single point group is bilateral Neiguan points(PC6), and the false
      stimulation group only attach electrodes without electric current. The frequency of TEAS is
      set to 2/15 Hz. Intraoperative anesthetic dosage of propofol and remifentanil was recorded.
      Three and six months after surgery, follow-up about chronic pain was made by telephone or
      face-to-face using the follow-up questionnaire. The adverse events were recorded.
    

Intervention name(s): acupoint stimulation; no stimulation
Intervention type(s): Device; Device
Intervention description(s): Electric stimulation was given through electrode attached to acupoints; patients were only attached electrodes without electric current
Other intervention name(s): transcutaneous electrical acupoint stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive Compulsive Disorders
Condition: Obsessive Compulsive Disorders
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Objectives.-Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive stimulation
      methods that became widely used as therapeutic tools in neuropsychiatric research. The aim of
      this study is to Evaluate the therapeutic impact of different frequencies of repetitive
      transcranial stimulation (1HZ, 10HZ) in OCD patients. Material and Methods; Forty five
      patients of OCD were participated in the study. All patients fulfilled the diagnostic
      criteria of DSM-IV-TR. The mean age of the patients was 27.1+4.5 years. Each patient was
      subjected to the following: Yale-Brown obsessive compulsive scale (Y-BOCS), Hamilton Anxiety
      Rating Scale (HAM-A), and Clinical Global Impression - Severity scale (CGI-S). The patients
      were randomly classified into three equal groups using closed envelop: 1st group received 1
      Hz rTMS at 100% of the RMT, 2nd group received 10 Hz rTMS with intensity of 100% of the RMT
      and 3rd group was sham group received the sham stimulation with a total 2000 pulses every day
      for each group for 10 sessions. Follow up of the patients using the same previous scales
      after the end of sessions and 3 months later.
    


Intervention name(s): rTMS-1Hz; rTMS-10 Hz; Sham rTMS
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
PALISADE Follow-on Study (ARC004)
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101
      through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed
      the ARC003 study.
    

Detailed description: 
      This is an international, multicenter, open-label, 2-arm follow-on study of the safety,
      tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the
      ARC003 study. This study will explore alternative dosing regimens during extended maintenance
      with AR101.
    

Intervention name(s): AR101
Intervention type(s): Biological
Intervention description(s): AR101 powder provided in capsules & sachets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Allergy; Peanut-Allergic Children; Peanut-Allergic Adults; Desensitization; PALISADE
Effects of Ketamine on Eye Movements, Perception and Brain Function
Condition: Functional Neuroimaging
Study type: Interventional

Summary: 
      In this study, the investigators examine the effects of low-dose ketamine on different
      oculomotor, perceptual and cognitive functions. They also examine effects on concurrent brain
      activity using blood oxygen level dependent (BOLD) functional magnetic resonance imaging
      (fMRI). A sample of N=25 healthy, male participants is required to complete the study. The
      design is within-subjects, placebo-controlled, double-blind and cross-over. A targeted
      ketamine level in plasma of 100ng/ml is applied. It is hypothesised that ketamine, compared
      to placebo, will lead to changes in task performance and brain activity similar to those
      observed in patients with schizophrenia.
    

Detailed description: 
      The uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist ketamine has been proposed
      as a model system of the symptoms of schizophrenia. To complement this model system and to
      allow neurobiological as well as translational studies, biomarkers are often applied to
      people under the influence of ketamine. Here, we apply oculomotor, perceptual and cognitive
      biomarkers to healthy human volunteers whilst they undergo BOLD fMRI at 3 Tesla field
      strength. We use a counter-balanced, placebo-controlled, double-blind, within-subjects
      design. A sample of 25 healthy participants is required. Participants will receive
      intravenous (IV) racemic ketamine (with a 100ng/ml target plasma concentration) on one of two
      assessment days and they will receive placebo (intravenous saline) on the other assessment
      day. BOLD fMRI will be carried out on a Siemens Trio scanner at the Life&Brain Centre, Bonn.
      In addition to brain functional and cognitive, perceptual and oculomotor responses, we will
      also measure self-ratings of psychosis-like experiences. These will be obtained using the
      Psychotomimetic States Inventory (PSI; Mason et al 2008).
    

Intervention name(s): Ketamine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Racemic ketamine, intravenous, at a concentration of 10mg ketamine per 50ml infusion; Saline, intravenous infusion
Other intervention name(s): Ketamin Ratiopharm; Kochsalzloesung
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Phase 1/2a Study of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1/2a open label study to evaluate the safety, tolerability, pharmacokinetics
      and anti-viral activity of PGT121, VRC07-523LS and PGDM1400 for HIV prevention and therapy.
    

Detailed description: 
      This is a Phase 1/2a open label study to evaluate the safety, tolerability, pharmacokinetics
      and anti-viral efficacy of PGT121, VRC07-523LS and PGDM1400 antibodies for HIV prevention and
      therapy. PGT121, VRC07-523LS and PGDM1400 are recombinant human IgG1 monoclonal antibodies
      that target a V3 glycan-dependent epitope region of the HIV envelope protein and the CD4
      binding site (CD4bs) of the HIV envelope protein. PGT121, VRC07-523LS and PGDM1400 mAbs were
      chosen for this study because of their potency, their ability to neutralize a wide array of
      cross-clade HIV viruses in a complementary pattern, and their proven antiviral activity in
      animal studies, e.g., their capacity to robustly prevent and treat simian-human
      immunodeficiency virus (SHIV) in rhesus monkeys.

      The potency and breadth of PGT121, VRC07-523LS and PGDM1400 raise the possibility that
      monoclonal antibodies may be effective for HIV prophylaxis at low doses and against global
      viruses. Neutralization sensitivity profiles are complementary; and the combination of these
      mAbs with unique epitope specificities will provide experience assessing the potential
      additive, synergistic, or antagonistic properties of two bNAbs given sequentially.
    

Intervention name(s): PGT121 + VRC07-523LS; PGT121 + VRC07-523LS + PGDM1400
Intervention type(s): Biological; Biological
Intervention description(s): PGT121 + VRC07-523LS, dose 30 mg/kg each, given intravenously; PGT121 + VRC07-523LS + PGDM1400, dose 20 mg/kg each, given intravenously
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV; AIDS; Monoclonal antibodies; Neutralizing antibodies; Analytical treatment interruption
Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the efficacy and safety of Atorvastatin in
      combination with multimodality therapy of concurrent radiotherapy plus temozolomide followed
      by adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM).The
      anticipated time on study treatment is until disease progression, and the target sample size
      is 32 individuals.
    


Intervention name(s): Atorvastatin; Temozolomide; Radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): 80 mg po daily until disease progression or unacceptable toxicity. (starting dose of 40 mg po daily for the first 21 days); 75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy; 60 Gy in 30 fractions
Intervention MeSH terms: Temozolomide; Atorvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase II; Atorvastatin; Temozolomide; Radiotherapy; Glioblastoma Multiforme (GBM)
Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics
Condition: Chronic Periodontitis; Diabetes Mellitus
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The aim of this study was to investigate the local effect of adjunct low-level laser therapy
      (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic
      patients.
    

Detailed description: 
      The aim of this study was to investigate the local effect of adjunct low-level laser therapy
      (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic
      patients. Twenty poorly-controlled type 2 diabetic patients with moderate to severe
      generalized chronic periodontitis were selected. Two periodontal pockets with Probing Depth
      (PD) and Clinical Attachment Level (CAL) ≥ 5mm received ultrasonic periodontal debridement
      (UPD) only (control group) or UPD with LLLT (test group). Clinical measures, such as PD, CAL,
      Gingival Recession (GR), Bleeding on Probing (BoP), and Plaque Index (PI), were collected and
      compared at baseline, 30, 90, and 180 days. The adjunct application of LLLT to UPD had no
      additional benefits for PD reduction and CAL gain, meaning that both investigated therapies
      were efficient for the treatment of chronic periodontitis in type 2 diabetics. Nevertheless,
      additional LLLT application showed better results for GR then UPD only.
    

Intervention name(s): Periodontal ultrasonic debridement; Debridement plus low-level laser therapy
Intervention type(s): Procedure; Device
Intervention description(s): Periodontal pockets received periodontal ultrasonic debridement intervention.; Ultrasonic debridement plus low-level laser therapy.
Other intervention name(s): periodontal debridement; ultrasonic debridement; low-level light therapy; low-power laser therapy; low-intensity laser therapy
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontal treatment; low-level light therapy