bioihbjkbjnl/mcl2 huggingface dataset:
Gleevec Idiopathic Pulmonary Fibrosis (IPF) Study
Condition: Idiopathic Pulmonary Fibrosis; Lung Disease; Pulmonary Fibrosis
MeSH terms: Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of Gleevec (imatinib
      mesylate) in the treatment of idiopathic pulmonary fibrosis (IPF).
    

Detailed description: 
      This is a multicenter, double-blind, parallel, placebo-controlled, randomized phase 2 study
      to evaluate the safety and efficacy of Gleevec (imatinib mesylate) in the treatment of
      Idiopathic Pulmonary Fibrosis (IPF). One-hundred- twenty patients will be enrolled in the
      trial in total. Subjects must have a diagnosis made by HRCT showing definite or probable IPF
      and clinical symptoms consistent with IPF with onset between 3 and 36 months prior to
      screening. Subjects will be randomly assigned to receive either Gleevec 600 mg orally or
      placebo, once per day for approximately 2 years. The primary efficacy will be progression
      defined as a greater than 10% decline in the forced vital capacity or death. Measures of
      safety will include all randomized patients who receive at least one dose of study
      medication. All adverse events and serious adverse events will be separately tabulated and
      mapped to a standard classification system and grouped by body system. Any serious adverse
      events that occur during the trial and 30 days after the end of therapy will be reported to
      the FDA within 24 hours and followed to outcome.
    

Intervention name(s): Imatinib Mesylate (Gleevec)
Intervention type(s): Drug
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Educational/Counseling/Training
Keywords: Pulmonary Fibrosis; Respiratory Diseases; Interstitial Lung Disease; Usual Interstitial Pneumonia
To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed and Fasted Conditions
Condition: Depression
MeSH terms: Malnutrition; Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg
      Clomipramine Hydrochloride capsules under fed and fasted conditions.
    


Intervention name(s): Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions; Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions; Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Clomipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antidepressant
Peri Implant Soft Tissue Healing in Single Implant Restoration Using Two Different Techniques
Condition: Oral Soft Tissue Conditions
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the present study was to propose the employment of Bio-Oss® and Bio-Gide® at
      implant site in order to evaluate if the increased bucco-lingual bone thickness could enhance
      the stability of peri implant soft tissue, when compared to the grafting technique (
      bilaminar technique), performed in association with implant placement .
    

Detailed description: 
      With respect to the soft tissue management many surgical approaches have been described in
      order to increase soft tissue volume and keratinized tissue height at implant site: roll
      flaps, connective tissue graft , epithelial connective tissue graft. In recent years, soft
      tissue substitutes , such as acellular dermal matrix or collagen matrix have been proposed to
      increase the dimensions of peri implant soft tissues; however, further studies have
      demonstrated that the allograft materials were less effective and less predictable than
      autogenous soft tissue grafts, in terms of increasing attached keratinized tissue , due to
      the considerable shrinkage and inconsistent quality of the attached tissue gained ;
      consequently soft tissue graft from the palate are currently considered the gold standard for
      augmenting peri implant soft. Some clinical studies proposed the association of contour
      augmentation by guided bone regeneration (GBR) with implant placement. The aim of these
      procedures is to restore the missing volume and to establish a facial bone wall of sufficient
      height and thickness to serve as a support for peri implant soft tissues; in these terms, GBR
      could be considered important to increase the stability of peri implant soft tissue ,
      preventing the marginal soft tissue shrinkage and the following exposition of implant . This
      could be a valid approach to stabilize coronal peri implant soft tissue and at the same time
      less traumatic than grafting procedures.
    

Intervention name(s): augmentation procedure with Bio-Oss® and Bio-Gide®; augmentation procedure with connective tissue graft
Intervention type(s): Device; Procedure
Intervention description(s): soft tissue management using GBR procedure; soft tissue management using the bilaminar technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aesthetic; connective tissue graft; mucosa thickness
Comparison of Two Identical NN1250 Formulations in Healthy Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate if two
      identical formulations of NN1250 (insulin degludec, IDeg) have the same level of drug
      exposure to the body.
    


Intervention name(s): insulin degludec; insulin degludec
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will be allocated to 2 single doses of trial product on 2 separate visits: One injection with formulation 1 and and one injection with formulation 2). Injected subcutaneously (under the skin).; Each subject will be allocated to 2 single doses of trial product on 2 separate visits: One injection with formulation 1 and and one injection with formulation 2). Injected subcutaneously (under the skin).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Crave Crush Neuroimaging Study
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of the research is to test whether a gymnemic acids (GA) lozenge will reduce
      reward region response to intake of high-sugar food and ad lib candy intake and whether the
      GA lozenge reduced reward region response to anticipated intake of high-sugar food and
      high-sugar food pictures relative to a placebo lozenge.
    

Detailed description: 
      Test the hypothesis that an acute dose of Crave Crush will produce greater reductions in
      reward region response to a taste of a high-sugar/high-fat beverage and anticipated receipt
      of this beverage than a placebo dose.

      Test the hypothesis that a dose of Crave Crush will result in reduced ad lib candy intake
      while the participants complete a survey after the fMRI scan. Participants will receive a
      second dose of Crave Crush or placebo. They will then be placed in a room to complete a few
      surveys. A bowl of candy will be placed on the table. Participants will be told that the
      candy is left over from their assessment and that they are free to have as much as they like,
      because the candy must be discarded after each participant.
    

Intervention name(s): Crave Crush; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Crave Crush is a dietary supplement that affects sweet taste receptors on the tongue.; The placebo tablet is comparable in taste and is comprised primarily of sorbitol.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hypertension; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and
      Atorvastatin in patients with hypertension and hyperlipidemia.
    


Intervention name(s): Irbesartan/Atorvastatin A; Irbesartan; Atorvastatin A; Placebo; Irbesartan/Atorvastatin B; Atorvastatin B
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): once daily, P.O. 8week; once daily, P.O. 8week; once daily, P.O. 8week; once daily, P.O. 8week; once daily, P.O. 8week; once daily, P.O. 8week
Other intervention name(s): HCP0912 A; HCP0912 B
Intervention MeSH terms: Irbesartan; Atorvastatin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Irbesartan; Atorvastatin; Hypertension; Hyperlipidemia
Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)
Condition: Sickle Cell Disease (SCD)
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the CSEG101A2202 study was to characterize the PK and PD of
      SEG101/crizanlizumab at 5 mg/kg and to evaluate the safety and efficacy of
      SEG101/crizanlizumab in SCD patients.
    

Detailed description: 
      Study CSEG101A2202 was designed as a Phase II, multicenter, open-label study. The first 45
      patients (to identify 27 evaluable patients) were enrolled to the treatment group
      crizanlizumab 5.0 mg/kg to complete full PK/PD sampling at week 1 and week 15. In all
      patients, trough PK/PD samples was collected prior to each dose. In addition, throughout the
      study (and when possible), all patients had blood drawn for serum to assess PK and PD drawn
      at times of onset and resolution of each VOC event, fever, or infection. Once the up to 45
      patients were enrolled, 12 additional patients were enrolled to the exploratory treatment
      group and begin at 7.5 mg/kg of crizanlizumab.
    

Intervention name(s): crizanlizumab
Intervention type(s): Drug
Intervention description(s): SEG101 (crizanlizumab) drug at a dose of 5.0 mg/kg (or 7.5 mg/kg for exploratory group) by IV infusion
Other intervention name(s): SEG101
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sickle cell disease; SCD; sickle cell anemia; vaso-occlusive crisis; P-selectin; SEG101; crizanlizumab; monoclonal antibody; Anemia, Sickle Cell; HbS Disease; Hemoglobin SC Disease; Sickle Cell Disorders; Sickling Disorder Due to Hemoglobin S
Effect of Denture Adhesives on Complete Denture Patients
Condition: Complete Edentulism
Study type: Interventional

Summary: 
      The effect of using denture adhesives on patient satisfaction with complete dentures; A
      randomized clinical trial.

      The study evaluates the effect of using 3 types of denture adhesives on patient satisfaction
      and quality of life of complete denture patients
    

Detailed description: 
      Aims: The aims of this study is to compare patient satisfaction and oral health quality of
      life without using denture adhesive and using 3 types of denture adhesives.

      Materials and Methods: 60 completely edentulous patients attending the University of Jordan
      hospital seeking new sets of complete dentures will be randomly divided into 3 groups (n=20).
      At delivery of complete dentures, all patients will be given the dentures with no denture
      adhesive and will be given review appointments after one month of using the dentures. At
      review appointment, patients will be asked to rate their overall satisfaction and their
      satisfaction regarding comfort, retention, stability, and efficiency of mastication and
      speech on a 100-mm visual analog scale (VAS). Participants also will fill out the oral health
      impact profile for edentulous patients (OHIP-EDENT) questionnaire. Each group will then be
      given one type of denture adhesive to use; paste-based Corega denture adhesive (CO), Sea Bond
      maxillary and mandibular denture adhesive strips (SB) and oil-based Olivafix denture adhesive
      (OF). Patients will be given instructions on how to use each type of adhesive and will be
      provided with sufficient amount for 1 month. After 1 month, patients will be asked to fill
      out the same forms
    

Intervention name(s): denture adhesive
Intervention type(s): Other
Intervention description(s): After 1 month of using the complete denture with no denture adhesives, patients fill up satisfaction and quality of life forms and given 1 of 3 types of denture adhesive to use for month to compare satisfaction and quality of life forms
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Complete dentures; Patient satisfaction; denture adhesives
A Study to Assess Safety, Tolerability and Pharmacokinetics of Ceftaroline in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of
      different dose regimens of Ceftaroline
    

Detailed description: 
      A Phase I, Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study
      to Assess the Safety, Tolerability, and Pharmacokinetics of Ceftaroline after Different
      Intravenous Dose Regimens of Ceftaroline Fosamil to Healthy Subjects
    

Intervention name(s): 600 mg Ceftaroline fosamil; Placebo; 600 mg Ceftaroline fosamil; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 h infusion; 1 h infusion; 2 h infusion; 2 h infusion
Intervention MeSH terms: Ceftaroline fosamil; Cephalosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; healthy volunteers; Parallel Group Study; ceftaroline fosamil different doses; safety; Cmax; tmax; AUC
Evaluation of a Probiotic Supplementation in the Immune Response of Participants With COVID-19 (Coronavirus Disease).
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      An interventional, randomized, double-blind, placebo-controlled study will be conducted to
      investigate the effect of a probiotic strain on the immune response in participants positive
      for SARS-CoV-2 infection.

      The study duration will be 28 days, which includes 4 weeks product administration.
      Participants will be randomized assigned to one of the two study groups: the control group
      with placebo consumption and a probiotic consumption group.
    


Intervention name(s): Probiotic: Lactobacillus salivarius + Vit D + Zinc; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A mixture of 1*10E9 colony forming unit (CFU) of Lactobacillus salivarius + Vit D + Zinc citrate in 1 capsule will be daily administrated during 28 days.; Placebo in 1 capsule will be daily administrated during 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Laparoscopic Versus Open Right Hemicolectomy Within ERAS in Right-sided Colon Cancer
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      In this study, the investigators have compared the clinical outcomes of the laparoscopic and
      open right hemicolectomy within enhanced recovery after surgery (ERAS) programs in the
      treatment of right-sided colon cancer.
    

Detailed description: 
      This study was a prospective, single-center, randomized control trial. Including criteria
      were (1) Age between 18 and 75 years; (2) Histologically confirmed right-sided colon
      adenocarcinoma；(3) Clinical stage I-III; (4) Performance status (ECOG) 0-1; (5) Adequate
      hematological, hepatic and renal function. Patients operated on as an emergency, or with
      tumours in the transverse colon, or with other previous malignancy within 5 years were
      excluded.

      All particapants were recruited and randomly assigned to receive laproscopic or open right
      hemicoloectomy. All patients were treated with an ERAS protocol. The primary end-point was
      the incidence of postoperative complications within 30 days. Complications were diagnosed and
      classified according to the Clavien-Dindo classification. The secondary end-points were ERAS
      adherence, readmissions, reoperations, hospital length of stay, mortality, and survivals. The
      study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai,
      China. Written informed consent was obtained for patients to participate the study. This
      study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.
    

Intervention name(s): Laparoscopic right hemicolectomy plus ERAS; Open right hemicolectomy plus ERAS
Intervention type(s): Procedure; Procedure
Intervention description(s): patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs; patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
Other intervention name(s): LRH ERAS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: enhanced recovery after surgery; right hemicolectomy
The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials
Condition: Healthy Controls
Study type: Interventional

Summary: 
      Healthy volunteers aged 21 to 50 are needed for a research study investigating whether pain
      will alter the binding properties of ([11C]diprenorphine), a molecule that can be used during
      brain imaging. Positron Emission Tomography (PET) and functional Magnetic Resonance (fMRI)
      imaging will be used in this study.
    


Intervention name(s): PET imaging
Intervention type(s): Radiation
Intervention description(s): Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma
Condition: Precancerous Condition
MeSH terms: Melanoma; Precancerous Conditions
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized phase II trial is studying how well sulindac works in preventing melanoma in
      healthy participants who are at increased risk of melanoma. Sulindac may stop the growth of
      tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known
      whether sulindac is more effective than a placebo in preventing melanoma in individuals with
      many moles and abnormal moles.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To determine sulindac and metabolite levels in healthy participants with atypical nevi and
      benign nevus at increased risk for melanoma treated with sulindac versus placebo.

      SECONDARY OBJECTIVES:

      I. To assess the effects of sulindac on apoptosis in atypical nevi of these participants.

      II. To assess the effects of sulindac on VEGF expression in atypical nevi of these
      participants.

      III. To assess sulindac and metabolite levels in plasma and its association with drug levels
      in the target tissue.

      OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 treatment arms.

      ARM I: Participants receive oral sulindac twice daily.

      ARM II: Participants receive oral placebo twice daily.

      In both arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.

      Blood and tissue samples are collected at baseline and/or after completion of study therapy
      and analyzed for sulindac and metabolite levels via high performance liquid chromatography
      tandem mass spectrometry; the detection of apoptotic cells via TUNEL assay; and VEGF
      expression via immunohistochemistry assays.

      After completion of study therapy, participants are followed for 2 weeks.
    

Intervention name(s): sulindac; placebo; laboratory biomarker analysis
Intervention type(s): Drug; Other; Other
Intervention description(s): Given orally; Inactive agent; Correlative studies
Other intervention name(s): Aflodac; Algocetil; Clinoril; SULIN; PLCB
Intervention MeSH terms: Sulindac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Rehabilitative Therapy and Pridinol in Patients With Lumbar Spondylarthrosis and Chronic Low Back Pain
Condition: Spondyloarthropathy
MeSH terms: Spondylitis; Spondylarthropathies; Spondylarthritis; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Spondyloarthrosis is a degenerative disease involving the intervertebral disc, vertebral
      bodies, and adjacent soft tissues. Treatment aims to slow disease progression and manage
      symptoms through an interdisciplinary approach.It can be conservative, pharmacological and
      interventional, rarely chirurgic. This study aimed to evaluate the effectiveness of a
      rehabilitation program combined with Pridinol Mesylate in the treatment of Spondyloarthrosis
      in elderly patients in terms of pain resolution, improving disability, and quality of life
      versus single treatment.

      A randomized controlled trial was conducted in patients with spondyloarthritis. The patients
      recruited were divided into three groups: the Combined Group (CG), who received a
      rehabilitation program combined with Pridinol Mesylate; the Rehabilitation Group (RG), who
      received only the same rehabilitation program; and the Drug Group (DG), who received only the
      administration of the drug.
    


Intervention name(s): Rehabilitation + Drug therapy; Rehabilitation; Drug therapy
Intervention type(s): Other; Other; Other
Intervention description(s): Patients in the Combo group underwent rehabilitation treatment combined with drug therapy: the rehabilitation protocol included daily sessions, 5 days a week, lasting 60 minutes, for a total of 4 consecutive weeks. Patients included in this group also took drug therapy, particularly Pridinol Mesylate orally, on an empty stomach, 2 mg x 3 times a day for 20 days.; Patients in the Reha group underwent rehabilitation treatment: the rehabilitation protocol included daily sessions, 5 days a week, lasting 60 minutes, for a total of 4 consecutive weeks. The treatment included an initial step, lasting 40 minutes, of Postural Reeducation ending with Stretching exercises of the posterior kinetic chain muscles lasting 20 minutes.; The Drug Group had taken Pridinol Mesylate orally, on an empty stomach, 2 mg x 3 times a day for 20 days. The tablet was taken without chewing and with a glass of water (200 ml). The drug was taken in environments with temperature below 25° C.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Spondylarthropathies; Pridinol Mesilate; Low Back Pain; Rehabilitation; Therapy