bioihbjkbjnl/mcl2 huggingface dataset:
Drug-Drug Interaction Study of Intravenous Administration of SyB V-1901 and Cyclosporine in Japanese Healthy Subjects
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of coadministered cyclosporine on the pharmacokinetics of
      brincidofovir following simultaneous administration of SyB V-1901 with cyclosporine, or
      coadministration of cyclosporine at 2 hours after the completion of SyB V-1901 infusion in
      healthy adult subjects
    

Detailed description: 
      This study is an open-label, randomized and crossover study designed to evaluate the effect
      of cyclosporine on the pharmacokinetics of SyB V-1901. Healthy adult subjects will receive an
      IV dose of SyB V-1901 alone, simultaneous administration of SyB V-1901 with cyclosporine, and
      coadministration of cyclosporine at 2 hours after completion of SyB V-1901 infusion. Eligible
      subjects will be randomized to one of two groups, to receive the treatment sequence of
      assigned group.
    

Intervention name(s): SyB V-1901; Cyclosporine
Intervention type(s): Drug; Drug
Intervention description(s): SyB V-1901 10 mg via IV infusion for 2 hours; 200 mg Capsule
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Mixed Venous Oxygen Saturation From Central Venous Line, Venous Side of Heart Lung Machine and the Pulmonary Artery
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Study type: Observational

Summary: 
      This study was designed to examine if venous saturations from the central venous line and
      from the venous side of the heart lung machine are interchangeable or not with mixed venous
      saturation from the pulmonary artery in children undergoing open heart surgery for correction
      of various congenital heart defects.
    

Detailed description: 
      Forty children aged from 1-15 years undergoing correction for different congenital heart
      procedures with cardiopulmonary bypass [CPB] were included in this study. Simultaneous
      samples were taken from the central venous line, pulmonary artery, and from venous side of
      the heart lung machine. Samples were taken after 10 minutes on full CPB and at the end of
      surgery before end of CPB. Bland and Altman plots were used to study the agreement between
      venous saturations.
    

Intervention name(s): venous saturations
Intervention type(s): Other
Intervention description(s): Samples of venous saturations from the central venous line (CVP), from venous side of the heart lung machine and from the pulmonary artery were taken at 10 min after being on CPB and after correction of the cardiac defects.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        cardiac surgery for children with congenital heart defects
      
Keywords: mixed venous saturation; open heart surgery; children
Stent Retriever for Thrombectomy Revascularisation of Large Vessel Occlusions in Acute Ischemic Stroke(Catfish)
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      The study is a randomized, prospective, parallel-group, multicenter, open-label,
      non-inferiority trial. Patients are randomized 1 : 1 to either stent retriever(Catfish) or
      Solitaire for endovascular therapy for acute ischemic stroke. The study aims to evaluate the
      benefit and safety of stent retriever(Catfish) for acute ischemic stroke therapy, as compared
      to Solitaire FR.
    

Detailed description: 
      The main objective is to determine whether stent retriever(Catfish) will have non-inferior
      successful recanalization rate compared to Solitaire in patients with acute ischemic stroke
      caused by large vessel occlusion.

      The secondary objectives is to verify whether there is significant differences in time from
      artery puncture to successful recanalization (mTICI 2b or greater), NIHSS score at 24 hours
      and at 7 days or discharge if earlier, good clinical outcomes at 90 days (defined as mRS
      score ≤2) between stent retriever(Catfish) and Solitaire in patients with acute ischemic
      stroke caused by large vessel occlusion.

      The third objectives is to compare the rate of symptomatic intracranial hemorrhage, serious
      adverse event(SAE), all cause of mortality with 90 days after operation, between stent
      retriever (Catfish) and Solitaire in patients with acute ischemic stroke due to large vessel
      occlusion.
    

Intervention name(s): Catfish; Solitaire FR
Intervention type(s): Device; Device
Intervention description(s): Patients will be treated for mechanical recanalization with Catfish within 8 hours after stroke onset plus standard medical management.; Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, randomized, open-label, parallel assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Topical Ibuprofen for Delayed Onset Mulscle Soreness
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the efficacy and safety of Ibuprofen 5% Topical Gel
      versus placebo administered two or three times daily for the treatment of pain associated
      with delayed onset muscle soreness following intense eccentric exercise of the elbow flexor
      muscles.
    


Intervention name(s): IBU BID; Placebo BID; IBU TID; Placebo TID
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days; 10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days; 10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days; 10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Delayed onset muscle soreness; ibuprofen; topical
Akin Osteotomy With or Without Fixation
Condition: Hallux Valgus
MeSH terms: Hallux Valgus
Study type: Interventional

Summary: 
      The study is a prospective randomized study about hallux valgus surgery. The investigator try
      to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an
      incidence in the first ray mobility since the two technics ( fixation and no-fixation) are
      described and practiced, and since the stiffness of the first metatarso-phalangeal joint is
      determinant in the result of this functional surgery.
    

Detailed description: 
      It's a prospective monocentric randomized work about forefoot surgery. Every patient included
      undergoes an hallux valgus chevron osteotomy of the first metatarsal associated with a
      percutaneous Akin osteotomy of the first phalange. The investigators study the impact of the
      fixation of percutaneous Akin osteotomy ( osteotomy of the first phalange of hallux) with two
      arms: one with fixation of the percutaneous Akin osteotomy, and one with a non-fixed
      percutaneous Akin osteotomy This study as been approved by Institutional review board;
      written informed consent is required for all patients before inclusion.

      The clinic follow-up of each patients included in the study will be the same of the normal
      follow-up for this type of surgery in our practice. This includes clinical exam, radiologic
      exam, and functional score AOFAS before surgery, at 6 weeks after the surgery, four months
      after surgery and finally one year after the surgery.

      The primary outcome measure which is the first metatarso-phalangeal global mobility will be
      blindly measure by an observator.
    

Intervention name(s): percutaneous Akin osteotomy
Intervention type(s): Procedure
Intervention description(s): The act to AKIN is osteotomy in percutaneous; This technique can be performed with or without fixation, and both methods make reference in the literature. With fixation method to get rid of the risk of loss of the surgical reduction of the misalignment, but requires an additional surgical procedure marked by the implementation of a percutaneous cannulated screw on part of the osteotomy. Without fixing method allows to get rid of this gesture, and risk a possible annoys by osteo-synthesis material. Surgical dressings of surgery of hallux valgus allow to keep the reduction for 15 days. Both techniques give excellent results and are performed in our service of routinely.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: percutaneous; non-fixed; Akin ;; osteotomy
A Study to Assess the Safety and Pharmacokinetics of HBI-002, an Oral Carbon Monoxide Therapeutic, in Healthy Volunteers
Condition: Anemia, Sickle Cell
MeSH terms: Anemia; Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open label Phase 1 clinical trial in normal adult subjects to assess
      safety, tolerability, pharmacokinetics, and pharmacodynamics of HBI-002, an orally
      administered liquid containing carbon monoxide (CO), with single ascending doses (SAD),
      followed by multiple dose with doses daily for 7 days.
    


Intervention name(s): HBI-002
Intervention type(s): Drug
Intervention description(s): Oral liquid carbon monoxide drug product.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Carbon Monoxide; CO; Heme Oxygenase; HO-1
Vitd and Barrier Function in IBD
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Increased Intestinal Permeability is detectable in clinically active Crohn's disease, in
      stable Crohn's disease and is predictive of clinical relapse. Maintenance of the epithelial
      barrier integrity is therefore essential for intestinal homeostasis. Vitamin D may have a
      critical role in improving barrier function.
    


Intervention name(s): Vitamin D; Soya Bean oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsule Form; Capsule form
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Crohn's Disease; Vitamin D; Intestinal Permeability; Tara Raftery
Comparative Study Between Pulsed and Continuous Itraconazole for the Treatment of Onychomycosis
Condition: Onychomychosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The term onychomycosis is used for a chronic fungal infection of the nail which when caused
      by dermatophytes, becomes tinea unguium. It not only includes the dermatophytes but also
      saprophytic molds infections and yeasts. Thorough literature research has revealed that 90%
      toenail and 75% fingernail onychomycosis are a result of dermatophytes arguably by
      Trichophyton mentagrophytes and Trichophyton rubrum. Comorbid conditions such as diabetes
      mellitus and peripheral arterial disease and immunosuppression due to HIV plays a catalytic
      role in its prognosis. In a study, upon comparison of placebo with continuous terbinafine 250
      mg daily for 24 weeks and continuous terbinafine 250 mg daily for 16 weeks, no significant
      differences were observed by the researchers between the two methods i.e continuous and pulse
      regimens of terbinafine, itraconazole, and fluconazole respectively. Moreover, in one another
      research study, the researchers also did not find significant superiority of continuous
      itraconazole 200 mg daily for 12 weeks over pulsed itraconazole 400 mg in the treatment of
      terms onychomycosis of mycological cure that is the reason why continuous daily itraconazole
      200 mg for 24 weeks has so far performed best in rank probabilities over other therapies, but
      its clinical significance is still debated. The purpose of carrying out this study was to
      carry out comparison between pulsed and continuous itraconazole for the treatment of
      onychomycosis as previous literature shows ambiguous results, therefore, this study will
      cement the rare evidence pertaining to the efficacy of pulsed and continuous itraconazole in
      the treatment of onychomycosis in our local population
    


Intervention name(s): Itraconazole
Intervention type(s): Drug
Intervention description(s): 100 mg two capsules of itraconazole were given twice daily to 30 patient group A for one week per month.baseline LFTs were also monitered
Other intervention name(s): capsule icon
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PD-1 Knockout Engineered T Cells for Advanced Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional

Summary: 
      This study will evaluate the safety of PD-1 knockout engineered T cells in treating advanced
      esophageal cancer. Blood or tissue samples will also be collected for research purposes.
    

Detailed description: 
      This is a prospective clinical study of ex-vivo selected, engineered, and expanded PD-1
      knockout T cells from autologous origin. 16 advanced esophageal cancer patients are planned
      to receive two cycles of PD-1 knockout engineered T cells infusion. Immunological markers are
      analyzed as well.
    

Intervention name(s): PD-1 Knockout T Cells
Intervention type(s): Other
Intervention description(s): Programmed cell death 1(PD-1) gene will be knocked out by CRISPR Cas9
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophageal cancer; immune checkpoint; PD-1; CRISPER; autologous cell infusion
Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection
Condition: Infertility; Infertility, Male
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      Laser-assisted intracytoplasmic sperm injection (ICSI) has been suggested as a more effective
      alterative to conventional ICSI when this method of insemination is indicated for patients
      undergoing in vitro fertilization (IVF). Laser-assisted ICSI differs from conventional ICSI
      in that a laser is used to drill a small hole through the hard outer coating surrounding an
      egg before the injection needle containing a single sperm is inserted into the egg. The hole
      eliminates compression of the egg that normally occurs with conventional ICSI, and thus may
      reduce the chance of damage. Laser-assisted ICSI is hypothesized to result in increased egg
      survival, and perhaps improved embryo quality, compared to conventional ICSI.
    


Intervention name(s): Laser-assisted intracytoplasmic sperm injection
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: In Vitro Fertilization; Intracytoplasmic Sperm Injection; Oocytes; Zona Pellucida; Oolemma; Fertilization; Preimplantation Embryo Development
Brazilian Diabetes Prevention Program: Pilot Study
Condition: PreDiabetes; Prediabetic State
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      To structure a Brazilian Diabetes Prevention Program based on guidance for changing lifestyle
      promoted by the American Diabetes Prevention Program, using materials already developed by
      the Brazilian Ministry of Health and contextualizing it to the Brazilian Public Health System
      (SUS) and evaluating its effectiveness in a multicentric randomized clinical trial with 220
      pre-diabetic patients and a follow up of 3 months. Outcomes are diet quality and time of
      physical activity. Health care professionals' perceptions regarding its incorporation into
      clinical practice will also be evaluated.
    

Detailed description: 
      This is a multicentric randomized clinical study coordinated by the Hospital Beneficência
      Portuguesa in São Paulo-Brazil and made possible by PROADI-SUS (SUS Institutional Development
      Support Program).

      The study's objective is the Brazilian Diabetes Prevention Program development based on
      guidance for changing lifestyle promoted by the American Diabetes Prevention Program, using
      materials already developed by the Brazilian Ministry of Health and contextualizing it to the
      Brazilian Public Health System (SUS).

      The program will not include a multidisciplinary orientation, but the prescription will have
      a multi-professional vision. The objective is to bring the multi-team together to discuss
      different aspects of the same intervention, such as accessibility, motivation, contexts, and
      needs, so that the program, to be guided by the nutritionist, can also be recognized and
      supported by the other teammates.

      Once the program is defined, the research teams from the collaborating centers will be
      trained and qualified. 220 individuals with pre-diabetes will be included in the study and
      followed for 3 months. Outcomes are diet quality and time of physical activity. Health care
      professionals' perceptions regarding its incorporation into clinical practice will also be
      evaluated.
    

Intervention name(s): Brazilian Diabetes Prevention Program; Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A Program structured in 7 visits (in group and individual) to guide the improvement of diet quality, self-care, and practice of physical activity; Hypocaloric diet prescription
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the role of autologous hematopoietic cell rescue in the treatment of multiple
      myeloma.
    

Detailed description: 
      To assess the toxicity and efficacy of sequentially administered high dose cyclophosphamide
      and VP-16 followed by total body irradiation or BCNU and high dose mephalan and autologous
      stem cell rescue in the treatment of multiple myeloma.
    

Intervention name(s): high dose chemotherapy then autologous hematopoietic cell transplant
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pain Increases After Shoulder Injection
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours
      following a shoulder injection.
    

Detailed description: 
      Corticosteroid injections are used to reduce pain and inflammation for various shoulder
      pathologies. Corticosteroid flare reaction is a well-described phenomenon that, despite being
      self-limited, causes significant pain and dysfunction. A flare reaction is defined for the
      purposes the study to be an increase of two or more points on a visual analog scale reported
      by the subject. Currently, there is a paucity of literature to drive the decision-making
      process between different corticosteroid medications. This study will compare the incidences
      of steroid flare reaction and three-month efficacy following methylprednisolone acetate (MPA)
      and triamcinolone acetonide (TA) corticosteroid injections into the glenohumeral joint or
      subacromial space.

      Physicians administering a steroid injection in the shoulder will utilize MPA until 200
      subjects have agreed to participate in this treatment arm. Enrollment will then be offered to
      200 subjects utilizing TA for the shoulder injection. Subjects receive treatment for their
      shoulder pain regardless of willingness to participate in the follow up reported pain scores.
      There are no costs to subjects for study participation.
    

Intervention name(s): Methylprednisolone (MPA); Triamcinolone Acetonide (TA)
Intervention type(s): Drug; Drug
Intervention description(s): injection into subacromial or glenohumeral space with MPA; injection into subacromial or glenohumeral space with TA
Other intervention name(s): depomedrol; kenalog
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in the Treatment of Children and Adolescents With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess whether duloxetine is superior to placebo in the
      treatment of children and adolescents with major depressive disorder (MDD)
    


Intervention name(s): Placebo; fluoxetine; duloxetine; duloxetine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks (acute treatment phase); 20 milligram (mg) orally, once daily for 10 weeks (acute treatment phase) and 20-40 mg orally, once daily for additional 6 months (extension phase); 60 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase); 30 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)
Other intervention name(s): LY110140; Prozac; LY248686; Cymbalta; LY248686; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride; Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment