bioihbjkbjnl/mcl2 huggingface dataset:
Karolinska Interventional Study of Mammograhic Density (Karisma-1)
Condition: Breast Cancer; Mammographic Density
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A feasibility study, randomising to either 10 or 20 mg of tamoxifen. The primary aim is to
      identify the time to mammographic density change and piloting the procedures. It is known
      that a density change is seen after 12 months of 20 mg of tamoxifen, but the clinical
      experience indicates that an effect of drugs influencing mammographic density could be seen
      already after a few months. The second aim is to evaluate if there is a density change from
      10 mg of tamoxifen equivalent to 20 mg.
    

Detailed description: 
      The investigators want to conduct a feasibility study including 42 women who will be
      randomised to either 10 or 20 mg of daily oral tamoxifen. The primary aim of the study is to
      identify the time to mammographic density change and piloting the procedures. It is known
      that a density change is seen after 12 months of 20 mg of daily tamoxifen, but the clinical
      experience indicates that an effect of drugs influencing mammographic density could be seen
      already after a few months. The second aim of the pilot study is to see if there is a density
      change from 10 mg of tamoxifen equivalent to 20 mg and if there is a difference in adverse
      reactions between the two doses. Interim analysis will be performed at 6 months, monitoring
      both safety and level of mammographic density change.
    

Intervention name(s): Tamoxifen
Intervention type(s): Drug
Intervention description(s): A registered SERM drug, Tamoxifen.
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Clinical Trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tamoxifen; Low-dose; Randomized Clinical Trial
Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,
      crossover, oral bioequivalence study.
    

Detailed description: 
      The objective of this study was to determine the single-dose oral bioequivalence of
      Ropinirole Hydrochloride Extended Release Tablets 2 mg of Dr. Reddy's Laboratories Limited,
      India with REQUIP® XL (Ropinirole) 2 mg ER Tablets of Glaxosmithkline, USA, in normal,
      healthy, adult, human subjects under fasting condition.
    

Intervention name(s): Ropinirole
Intervention type(s): Drug
Other intervention name(s): Requip
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Ropinirole Hydrochloride; crossover
Study to Asses Efficacy of Intralymphatic Immunotherapy
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to try a new route for specific immunotherapy (SIT). The current
      treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50
      injections subcutaneously in the upper arm.

      The investigators believe that there is additional effect if the allergen is injected
      directly into the lymph node, since it is here, the allergen presentation is happening. The
      trial has been performed in Switzerland with significant effect of only three injections of
      grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457).

      The investigators would like to see what happens if the the dose is doubled, so the patients
      will receive 6 injections all in all, with the same amount of allergen as the earlier study
      (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note
      their symptoms in a diary.

      The patients will be divided into three groups using allocation:

      1 group with 6 injections of allergen

      1 group with 3 injections of allergen and 3 injections of placebo

      1 group with 6 injections of placebo. The trial will be double blinded.
    


Intervention name(s): phleum pratense (grass-allergen); phleum pratense (grass allergen); physiological saline
Intervention type(s): Biological; Biological; Other
Intervention description(s): 6 injections of grass-allergen. Every dose will be 1000 SQ-U.; 3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline); 6 injections of placebo (physiological saline)in a lymph node.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: grass-pollen allergy
Secondary Prophylaxis of Gastric Variceal Bleed
Condition: Gastric Varices
MeSH terms: Esophageal and Gastric Varices
Study type: Interventional

Summary: 
      The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection
      versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric
      variceal rebleeding and improvement in survival.
    


Intervention name(s): Balloon-occluded retrograde transvenous obliteration; Endoscopic cyanoacrylate injection; N-butyl-2-cyanoacrylate; Lauromacrogol
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): Balloon-occluded retrograde transvenous obliteration; Endoscopic cyanoacrylate injection
Intervention MeSH terms: Polidocanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of In-vitro Myoinositol Supplementation of Human Sperm on the Outcome of Cryopreservation
Condition: Myoinositol; Cryopreservation; Human; Sperm
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation
      of human sperm on the outcome of cryopreservation.
    

Detailed description: 
      Sperm cryopreservation is considered the most valuable and used way to preserve male
      reproductive function. Unfortunately, osmotic effects of freezing and thawing during the
      cryopreservation process negatively affect sperm morphology and motility .

      Myoinositol is the most biologically important form of inositol in nature. In male
      reproductive system, myoinositol appears to regulate sperm motility, capacitation and
      acrosomal reaction.

      The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation
      of human sperm on the outcome of cryopreservation.
    

Intervention name(s): Myoinositol
Intervention type(s): Biological
Intervention MeSH terms: Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This is a research study designed to look at how pomegranate juice (or a placebo juice)
      affects the body through the measurement of specific biomarkers, which are indicators of
      health.
    

Detailed description: 
      This research study will evaluate how pomegranate juice (or a placebo juice) affects the
      body. Participants will be asked to drink 8 oz. of juice daily for 12 weeks. Biomarkers,
      which are indicators of health, will be measured throughout the study. They are present in
      blood and urine. The placebo is a juice that is not made from pomegranates, but resembles
      pomegranate juice in color and taste. Eating pomegranates has been shown to have a positive
      impact on certain biomarkers. Recent studies have shown that biomarkers can be indicators of
      general health. The investigators want to know if drinking pomegranate juice daily for 12
      weeks is effective at improving a variety of biomarkers in diabetic adults.
    

Intervention name(s): Pomegranate Juice; Placebo Juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Group A drinks 8 oz. pomegranate juice/day for 12 weeks; Group B drinks 8 oz. placebo juice/day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Diabetes; Pomegranate; Biomarkers; Antioxidant
Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms
Condition: Major Depressive Disorder; Anxiety
MeSH terms: Anxiety Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy and safety of flexibly dosed
      adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety
      symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor
      (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response.
    


Intervention name(s): Brexpiprazole
Intervention type(s): Drug
Intervention description(s): Treatment (6 weeks) - Up to 3mg/day, once daily dose, tablets, orally
Intervention MeSH terms: Brexpiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; Major depressive disorder; Anxiety Symptoms; Mental Disorders; Psychotic Disorders; emotional withdrawal; antipsychotic
Yoga in an Urban School for Children With Emotional Behavioral Disorders
Condition: Emotional Behavioral Disorders
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      Yoga is becoming a part of therapies for children with emotional behavioral disorders. The
      goal is to examine the feasibility and efficacy of yoga sessions for children with emotional
      behavioral disorders at an urban elementary school.
    

Detailed description: 
      Participants: children in 4th and 5th grade at an urban elementary school, identified by the
      special education director and the teaching staff, as having emotional behavioral disorders
      including anxiety, depression, aggression, conduct disorder, hyperactivity and attention
      difficulties. These grades have a combined student population of 160 students. Enrolled over
      two years.

      Inclusion/Exclusion criteria:

      Eligible if identified by the teaching staff or special education director as having an
      emotional behavioral disorder. Exclusion criteria: inability to comprehend English
      sufficiently to complete written assessments and follow the yoga intervention.

      Pre- and post-intervention assessments (teachers)

        1. Behavior Assessment Scale for Children (BASC).

        2. The Swanson, Kotkin, Agler, M-Flynn & Pelham Rating Scale (SKAMP)
    

Intervention name(s): yoga intervention
Intervention type(s): Behavioral
Intervention description(s): yoga session 2 x week over 3-1/2 months
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: yoga; emotional behavioral disorder; intervention; school; meditation; focus: yoga intervention in students with emotional behavioral disorders in an urban school
Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head
Condition: Avascular Necrosis of Femur Head
MeSH terms: Osteonecrosis; Legg-Calve-Perthes Disease; Femur Head Necrosis; Necrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral
      head in comparison to the standard treatment of isolated core decompression.

      XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous
      mesenchymal stem cells fixed in allogenic bone tissue.

      The working hypothesis proposes that the tissue engineering is a valid and useful technique
      to achieve bone regeneration, avoiding the progression to collapse of the femoral head.
    

Detailed description: 
      Prospective, open-label with blinded assessor, randomized, parallel, single-dose phase I-II
      clinical trial in which 24 patients affected with osteonecrosis of the femoral head ARCO
      grade I or II will enter the trial with the primary objective of assessing the feasibility
      and safety of "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone
      tissue in osteonecrosis of the femoral head. Secondary objectives are to assess the efficacy
      of the implantation by imaging (magnetic resonance imaging) and clinical questionnaires (pain
      by visual analogue scale, quality of life by SF-36 and WOMAC Index).

      Patients will be randomized to one of the two treatment arms (core decompression and the
      tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells
      fixed in allogenic bone tissue or the standard treatment of isolated core decompression).
      Thereafter, patients will be followed for 12 months.
    

Intervention name(s): XCEL-MT-OSTEO-ALPHA; Standard treatment
Intervention type(s): Biological; Procedure
Intervention description(s): Core decompression plus XCEL-MT-OSTEO-ALPHA; Isolated core decompression
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Avascular Necrosis of Femur Head; Osteonecrosis of the hip; Osteonecrosis of the femoral head; Mesenchymal Stem Cells; Bone marrow; Tissue engineering; Bone Diseases; Musculoskeletal Diseases
Outcomes of the Modified-Brostrom Procedure Using Suture Anchor for Chronic Lateral Ankle Instability
Condition: Chronic Ankle Instability
Study type: Observational

Summary: 
      This prospective, randomized study was conducted to compare the clinical outcomes of the
      modified Brostrom procedure using a suture anchor and bone tunnel for chronic lateral ankle
      instability.
    

Detailed description: 
      With With the increased number of participants in sports and leisure time activities, the
      incidence of ankle ligament injuries has been correspondingly increased. Various surgical
      methods have been reported for chronic ankle instability. Of these methods, the modified
      Brostrom procedure is currently used most frequently, and its excellent treatment outcomes
      have been reported. If there are any methods for obtaining a strong ligament fixation force
      which are both technically simple and safe, such methods would shorten the operative time and
      be helpful for surgeons with little experience in managing chronic ankle instability to
      obtain excellent treatment outcomes. In recent years, a procedure using a suture anchor,
      which is used for various types of ligament or tendon reconstructions, has been frequently
      performed. To date, however, few studies have reported clinical outcomes of suture anchor
      techniques and comparisons of clinical results between suture anchor techniques and other
      procedures. Given the above background, we prospectively compared the clinical outcomes
      between the bone tunnel and suture anchor techniques in the modified Brostrom procedure for
      chronic lateral ankle instability.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Of patients who underwent the modified Brostrom procedure under the diagnosis of chronic
        lateral ankle instability, 40 patients (40 ankles) who could be followed during a minimum
        period of 2 years were enrolled in the current study. The current study included patients
        who complained of unilateral ankle joint instability.
      
Keywords: Ankle; Chronic lateral instability; Modified Brostrom procedure; Suture anchor; Bone tunnel
Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I clinical study is a randomized, double-blind, placebo-controlled,
      parallel-design study to thoroughly assess the safety profile and PK properties of J147 in
      healthy subjects. The study will include single ascending dose (SAD) in healthy young and
      elderly subjects.
    

Detailed description: 
      This Phase I clinical study is a randomized, double-blind, placebo-controlled,
      parallel-design study to thoroughly assess the safety profile and PK properties of J147 in
      healthy subjects and to perform a preliminary assessment of the effect of food on safety and
      PK parameters of J147. The study will include single ascending dose (SAD) in healthy young
      and elderly subjects.

      Approximately 64 subjects may be included in the study, with an additional 24 to be added
      depending on the emerging data.

      Six cohorts of 8 healthy young male subjects and 2 cohorts of 8 healthy elderly male and
      female subjects are planned. Depending on emerging safety, tolerability and PK data, 2
      additional cohorts of 8 healthy young male subjects in each cohort and 1 additional cohort of
      8 elderly male and female subjects may be enrolled.

      In each cohort, 6 subjects will be randomized to receive a single dose of J147 orally and 2
      subjects will be randomized to receive a matching dose of placebo.

      All cohorts will consist of 2 sentinel subjects of whom 1 subject will receive J147 and 1
      subject will receive matching placebo. The remaining 6 subjects of whom 5 subjects will
      receive J147 and 1 subject will receive matching placebo will be dosed at least 24 hours
      following the sentinel subjects.

      Healthy elderly subjects will receive doses that have been found to be safe in healthy young
      subjects.
    

Intervention name(s): J147; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of J147; Single oral dose of corn oil
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Subjects will receive a single dose of J147 or placebo in a fasted state. The dose levels are planned to be administered in ascending order. Progression to the next dose level, and dose selection, will be based on all available safety and tolerability data up to at least 48 hours post-dose and available PK data (up to at least 24 hours post-dose) from a minimum of 6 subjects (J147 n ≥4) in the preceding dose cohort. Healthy elderly subjects will receive doses that have been found to be safe in healthy young subjects.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dementia; Neurodegenerative Disease
Couples-Based Mindfulness for Young Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study aims to improve relationship, psychological, and physical adjustment among young
      breast cancer survivors (YBCS; diagnosed at age 45 or younger) and their committed/life
      partners. A mindfulness-based stress reduction (MBSR) intervention has been designed to meet
      the specific needs for young breast cancer survivors and their partners. The intervention
      will be administered in your home by using recorded videos of a trained MBSR instructor.
      Before, during, and after the 8-week intervention, participants will be asked to complete
      surveys.
    

Detailed description: 
      Participants will be young breast cancer survivors (YBCS) and their partners. Young breast
      cancer survivors are those diagnosed at age 45 or younger. This study includes stress
      reducing interventions known to have a positive influence on physical and psychological
      functioning that will be administered through recorded videos. The interventions include
      watching an hour-long video stress-reduction class, each week, for 8 weeks and practicing
      guided meditations. YBCS participants will be randomly assigned to either an 8-week
      mindfulness-based stress reduction course designed for couples (C-MBSR) or an 8-week
      mindfulness-based stress reduction course for individuals. At the end of the study all
      participants (regardless of what assignment) will receive both sets of stress-reducing
      videos. Partners of the YBCS assigned to the couples condition will also be asked to watch
      the 8 C-MBSR videos. Some young breast cancer survivor participants and their partners will
      be asked to complete provide salivary cortisol and all survivors and partners will be asked
      to complete the 4 surveys.
    

Intervention name(s): Couples MBSR; Individual MBSR
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Both members of the couple will be asked to participate in the weekly video sessions and activities.; Only the young breast cancer survivor will participate in the weekly video sessions and activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Couple Functioning; Stress Reduction
A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one
      research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age,
      randomized in a 1:1:1 ratio to assess plasma, vaginal fluid and vaginal tissue levels and the
      pharmacokinetics of dapivirine when applying either Dapivirine Gel 4750, 0.05%, 2.5g or
      Dapivirine Gel 4789, 0.05%, 2.5g intravaginally for 11 days (1 day followed by a 3 day
      washout period and then 10 consecutive days); and to assess the safety of these gels as
      compared to the intravaginal HEC-based universal placebo gel.
    


Intervention name(s): Dapivirine Gel 4750, 0.05%, 2.5g; Dapivirine Gel 4789, 0.05%, 2.5g; HEC-based Placebo Gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intravaginal gel, dosed daily; intravaginal gel, dosed daily; intravaginal gel, dosed daily
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV-1 Infection; HIV Seronegativity