bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Condition: Vaccines, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate
      (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months
      (infant series) and at 11-12 months of age (toddler dose) in Germany.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine; 7-valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age; Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: safety; Vaccine
Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander
Condition: Rhinoconjunctivitis With or Without Allergic Asthma
Study type: Observational

Summary: 
      Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy
      With Beltavac® Polymerized With Cat Dander in allergic patients
    

Detailed description: 
      This prospective open multi-centre non-interventional study assess the safety and
      effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac®
      Polymerized with cat dander allergic patients (children and adults) in routine medical care.
      Patients receive a rush schedule administration every month for a year. They attend at least
      5 study visits to inform about the adverse reactions, the self reported symptoms and the
      medication intake.
    

Intervention name(s): Beltavac® Polymerized with cat dander
Intervention type(s): Biological
Intervention description(s): Adminstration of Beltavac® Polymerized with cat dander according to the routine clinical practice
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis caused by cat
        dander
Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044
      in premature ejaculation
    


Intervention name(s): dapoxetine
Intervention type(s): Drug
Intervention description(s): multiple dosing
12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine
Other intervention name(s): Priligy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma
Condition: Lymphoma, Large B-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 3

Summary: 
      This multicenter, randomized, open label parallel-group study will evaluate the efficacy and
      safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with
      CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell
      lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg
      subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8
      cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study
      treatment is 6 months.
    


Intervention name(s): CHOP; rituximab [MabThera/Rituxan]; rituximab [MabThera/Rituxan]
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles; The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles; 375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Radiofrequency and Pulsed Electromagnetic Field Treatment of Skin Laxity of the Mon Pubis, Labia and Vaginal Introitus
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      The study will confirm that the Freeze Diamond polar applicator is safe for treating the Mons
      pubis and Labia, and will result in improvement in general skin appearance including an
      improvement in skin irregularities and skin laxity.
    

Detailed description: 
      This is a single-center, open-label, prospective study. Ten (10) subjects that meet the
      inclusion criteria will be enrolled from the site's pool of patients. Subjects should be a
      female at the age of 25-65, and have a suitable treatment area (e.g. skin irregularities
      and/or unwanted skin laxity in the Mons pubis, Introitus and/or Labia area).

      Subjects will receive three treatments with the study device, at four week intervals,
      followed by one month follow-up visits after the last treatment.
    

Intervention name(s): Venus Freeze Diamond Polar
Intervention type(s): Device
Intervention description(s): The Venus Freeze Diamond Polar is a non-invasive dermatological treatment system that combines Multi Polar Radiofrequency and Pulsed Magnetic Fields. The radiofrequency energy penetrates the skin and results in tissue heating that has known effect on skin laxity, the magnetic field that is simultaneously induces increases fibroblast collagen production through non thermal mechanism and contributes to the clinical effect of skin laxity improvement. Only the Diamond Polar applicator will be used in this study for the treatment of the Mons pubis, vaginal introitus and Labia. Minor modification to the hand-piece for operator and/or patient comfort may occur mid-study, however no change in range of energy modality or amount of energy delivered will occur at any point during the study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Brain Activities in Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Observational [Patient Registry]

Summary: 
      To address joint position sense in cervical dystonia patients and how it affects the brain
      activity.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with cervical dystonia will be recruited from the University of Minnesota's
        Movement Disorders Clinic.
A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker
      response of BMS-986165 administered orally in participants with moderate to severe ulcerative
      colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks
      compared to placebo. After the initial 12-Week period, all subjects receive active therapy
      (open-label extension). With protocol amendment 2, one of the dose treatment arms is being
      removed from the 12-week double blind period with no change to the open-label extension.
    


Intervention name(s): BMS-986165; Placebo Comparator
Intervention type(s): Drug; Other
Intervention description(s): Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Deucravacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hypertonic Saline as Therapy for Pediatric Concussion
Condition: Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This single center, blinded, randomized controlled trial evaluated the use of hypertonic
      saline versus normal saline as therapy for the symptoms of pediatric concussion post head
      injury.

      The study hypothesis was that hypertonic saline would improve symptoms of pediatric
      concussion following head injury as measured on the self-reported Wong Baker Faces Pain Scale
      as compared to normal saline.

      The null hypothesis was that there would be no difference in change of reported pain in
      either group.
    


Intervention name(s): Hypertonic Saline; Normal Saline
Intervention type(s): Drug; Other
Intervention description(s): intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour; intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour
Other intervention name(s): 3%; HTS; NS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis
Condition: Erosive Gastritis
MeSH terms: Gastritis
Study type: Interventional

Summary: 
      The investigators performed a double-blind parallel study in a group of Subjects Showing
      Erosive Gastritis who were given Hizikia Fusiformis Extract over a period of 4 weeks.
      Endoscopic observations were performed before and 4 weeks after the treatment, and the cure
      and improvement rates were investigated.
    


Intervention name(s): Hizikia Fusiformis extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Hizikia Fusiformis extract(1.3g/d); Placebo(1.3g/d)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Erosive Gastritis; Hizikia Fusiformis
Effects of Laughter Yoga on Hemodialysis Patients' Plasma-Beta Endorphin Levels, Pain Levels and Sleep Quality
Condition: Laughter Yoga; Hemodialysis Patients
Study type: Interventional

Summary: 
      This study aimed to assess the effectiveness of laughter yoga on HD patients' plasma beta
      endorphin levels, pain levels and sleep quality.
    

Detailed description: 
      While there are studies conducted with laughter yoga on different patient groups in Turkey,
      no studies have been found on hemodialysis patients specifically. For this reason, it was
      thought that studies are needed which will prove the effect of laughter yoga practices on the
      plasma beta-endorphin levels, pain levels and sleep quality of hemodialysis patients.
    

Intervention name(s): Laughter yoga
Intervention type(s): Behavioral
Intervention description(s): The laughter yoga practice was initiated through clapping and warm-up exercises: hands were clapped keeping hands in parallel with each other and ensuring that the fingertips touched each other. To increase the energy level of the group, a rhythmic beat was added to the clapping in the form of 1-2, 1-2-3. While this was being sung a rhythm was tapped out on the floor by moving the feet up and down. Eye contact was constantly maintained with the participants. In the second phase, deep breathing exercises were performed. Participants were encouraged to inhale from the diaphragm. Individuals were asked to put their hands on their belly and inhale through the nose and then slowly exhale through the mouth. After the deep breathing exercise, the participants were encouraged to laugh through playing children's games in the third phase.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment Randomization; participants were divided into two groups by using simple random numbers table, and then the first group which was drawn by lot method was named as the experimental group.
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Laughter Yoga; Hemodialysis; Pain; Sleep; Beta Endorphin
A Study of YM178 in Patients With Symptomatic Overactive Bladder
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability
      compared to placebo
    

Detailed description: 
      To investigate the dose-response relationship of YM178 in terms of efficacy, safety and
      tolerability, and also the superiority of YM178 over placebo.
    

Intervention name(s): YM178; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Intervention MeSH terms: Mirabegron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: YM178; Urinary Bladder, Overactive
Primary Cell Culture of Hepatic Tumorous Cells From Routine Fine-needle Aspiration
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      The purposes of this prospective study were to evaluate the successful rate of primary
      culture of hepatocellular carcinoma cells and cancer-associated fibroblasts from the residual
      specimens in routine fine-needle aspiration of hepatic tumor and the potential application of
      this method as an additional tool for personalized treatment of hepatocellular carcinoma
      patients.
    

Detailed description: 
      Fine-needle aspiration (FNA) cytology or biopsy of hepatic tumor is frequently applied in the
      collection of specimens because it is considered safe, efficacious, accurate and cost
      effective. Our previous study from small number of patients showed that specimens obtained
      from FNA had potential to be applied for primary culture of cancer cells. This study was to
      modified our method for primary culture of both hepatocellular carcinoma cells and
      cancer-associated fibroblasts in patients with tumor measuring larger than or equal to 3cm.
      All patients received one session of aspiration for the diagnosis of hepatic tumor. The
      aspirated specimens were applied for both cytologic and pathologic examinations at first.
      After then, 10 mL 0.9% NaCl was aspirated by the same needle connected with the same syringe
      and injected into 15 mL sterilized centrifugation tube. If the tube contained visible
      specimens, these specimens were sent for primary culture.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with hepatic tumor measuring larger than or equal to 3 cm underwent fine-needle
        aspiration of tumor for diagnosis.
      
Biospecimen description: 
      cancer cells and cancer-associated fibroblasts
Zevalin-beam for Aggressive Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 3

Summary: 
      The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning
      regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation
      in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall
      and disease-free survival.
    


Intervention name(s): ibritumomab tiuxetan; BEAM chemotherapy and autologous stem-cell transplantation
Intervention type(s): Drug; Procedure
Intervention description(s): 0.4 mCi/kg
Other intervention name(s): zevalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-Hodgkin's lymphoma; autologous stem cell transplantation; radioimmunotherapy; zevalin
Opposite SI Joint Stretching for GIRD
Condition: Shoulder Impingement
MeSH terms: Shoulder Impingement Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if stretching the contralateral sacroiliac (SI)
      joint improves GIRD in baseball players. Additionally, we aimed to compare our SI joint
      stretching regiment with a classically described sleeper stretch routine.
    

Detailed description: 
      Abstract:

      Background:

      Glenohumeral Internal Rotational Deficit (GIRD) is a well-documented finding in throwing
      athletes.

      Hypothesis/Purpose:

      The purpose of this study is to investigate if stretching the contralateral sacroiliac (SI)
      joint improves GIRD in baseball players. Additionally, the effect of the SI joint stretch
      will be compared to that of the classically described sleeper stretch.

      Study Design:

      Randomized Controlled Clinical Trial

      Methods:

      With the athlete supine and arm abducted 90o, internal rotation of both shoulders was
      measured in 23 minor league baseball players.

      Next, each player randomly was assigned to either a control (sleeper stretch of dominant
      shoulder) or experimental (stretch of the SI joint contralateral to the dominant shoulder)
      group supervised by a certified athletic trainer. The players performed their own stretches.

      Finally, the initial two investigators, unaware of to which group the player was assigned,
      re-measured the end-range internal rotation of each athlete's dominant shoulder.
    

Intervention name(s): Sleeper Stretch; Opposite SI joint Stretch
Intervention type(s): Procedure; Procedure
Intervention description(s): Internal Range of motion of dominant shoulder; Internal range of motion of dominant shoulder
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: All 23 players of a minor league baseball team voluntarily participated in the study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glenohumeral internal rotational deficit; GIRD; Sleeper stretch; SI joint stretch
First-In-Human Study Of Single And Multiple Ascending Doses Of PF-06751979
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, PK and PD of PF-06751979
      following oral doses in healthy adult and healthy elderly subjects.
    


Intervention name(s): PF-06751979 single ascending dose; Placebo single dose; PF-06751979 multiple ascending dose; Placebo multiple dose; PF-06751979 multiple dose; PF-06751979 multiple dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-06751979 administered as a single dose (solution/suspension) in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of PF-06751979). The dose levels are 3 mg, 12 mg, 40 mg, 160 mg.; Matched Placebo solution/suspension administered as single dose.; PF-06751979 (solution/suspension) administered daily for 14 consecutive days to parallel cohorts. The dose levels are 5 mg, 15 mg, 50 mg.; Matched Placebo (solution/suspension)administered daily for 14 consecutive days.; PF-06751979 (solution/suspension) administered daily for 14 consecutive days. The dose level is 50 mg.; Matched Placebo (suspension/solution) administered daily for 14 consecutive days to parallel cohorts.
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Alzheimer's disease
Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD); Asthma
MeSH terms: Asthma; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of single doses of
      LAS190792 administered by inhalation to patients with mild persistent asthma and moderate to
      severe chronic obstructive pulmonary disease (COPD) and also to assess the ability of
      LAS190792 to produce bronchodilation (opening of the airways).
    

Detailed description: 
      This study is an integrated Phase I protocol divided into 2 parts.

      Part one: a single ascending dose study (6 LAS190792 dose levels) in 16 male subjects with
      mild asthma. LAS190792 will be administered (by the Genuair® inhaler) under supervision at
      the study centre, according to the randomisation scheme. One dose level will be administered
      per week with 2 to 3 weeks between each dose level for the safety and pharmacokinetic data
      review.

      Part two: A 5-way , crossover, single dose study (of LAS190792 [two doses], indacaterol,
      tiotropium and placebo) in 40 male and non-childbearing potential women subjects with
      moderate to severe COPD. Each treatment period will be separated by a washout period of at
      least 7 to 14 days. The aim is to ensure at least 30 subjects complete Part 2 of the study.
      The primary comparison for bronchodilation will be between LAS190792 doses and placebo. Other
      treatment comparisons (indacaterol or tiotropium vs placebo and LAS190792 vs indacaterol or
      tiotropium) will be considered additional.
    

Intervention name(s): LAS190792 Dose 1; LAS190792 Dose 2; LAS190792 Dose 3; LAS190792 Dose 4; LAS190792 Dose 5; LAS190792 Dose 6; LAS190792 Dose 1 (Part 2); LAS190792 Dose 2 (Part 2); Tiotropium 18 μg; Indacaterol 150 μg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Spiriva; Onbrez
Intervention MeSH terms: Tiotropium Bromide; LAS190792
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment