bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      The aim of the current study is to evaluate the efficacy of a probiotic product on bone
      mineral density (BMD) in healthy early post-menopausal women, compared to placebo. The
      primary endpoint is to assess changes of BMD at lumbar spine after an intervention period of
      12 months. Changes in BMD at the femoral neck (hip) will also be measured as well as changes
      in bone turnover markers during the period of 12 months.
    


Intervention name(s): Placebo; : Probiotic capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The intervention consists of capsules containing placebo.; The intervention consists of capsules containing probiotics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddys's Laboratories Limited Under Non-Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the relative bioavailability study of tacrolimus
      capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under non-fasting
      conditions and to monitor safety of subjects.
    

Detailed description: 
      An open label, randomized, two period, two treatment, two sequence, crossover, balanced,
      single dose, comparative evaluation of relative bioavailability of tacrolimus capsules 5 mg
      with that of 'prograf' capsules 5 mg in healthy adult human subjects under non-fasting
      conditions.
    

Intervention name(s): Tacrolimus Capsules
Intervention type(s): Drug
Intervention description(s): Tacrolimus Capsules, 5 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Prograf capsules of Astellas Pharma US, Inc.,
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability, crossover, tacrolimus
Chronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)
Condition: Overweight
MeSH terms: Cardiovascular Diseases; Overweight; Insulin Resistance
Study type: Interventional

Summary: 
      The investigators hypothesized that there will be a significant difference between the
      effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on
      cardiovascular disease, inflammation, insulin resistance and obesity.
    

Detailed description: 
      Human volunteers will be conditioned for a 8 wk intervention on 3 different test diets
      providing 30 % energy as fat, 15% energy as protein and 55% energy as carbohydrate according
      to parallel designed sequences. The test fats used for this study are palm oil, chemically
      interesterified palm oil and chemically interesterified fully hydrogenated soybean oil and
      soft oil blend in the form of margarine. Volunteers will be restricted to follow the dietary
      guidelines throughout the study. Blood collection sessions will held before and after every
      diet intervention. Outcome measures of the study are serum lipid profile, markers of
      inflammation, markers of obesity and insulin resistance.
    

Intervention name(s): Palm Olein; IE Palm olein; IE soybean oil-based
Intervention type(s): Other; Other; Other
Intervention description(s): 8 weeks; 8 weeks; 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to extend the use of opicapone 25 or 50mg once per day by
      subjects who participated in the BIA 9-1067-302 clinical trial according form 4a for
      additional three years.
    


Intervention name(s): Opicapone
Intervention type(s): Drug
Intervention description(s): 25mg or 50mg once per day
Intervention MeSH terms: Opicapone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PD; Off periods; quality of life; dyskinesia; end-off-dose motor fluctuations
Let's Play! Healthy Kids After Cancer
Condition: Childhood Acute Lymphoblastic Leukemia in Remission; Obesity
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

Summary: 
      This pilot study will evaluate the feasibility, acceptability, and potential efficacy of a
      parent-targeted, phone-based program to prevent unhealthy weight gain and improve biomarkers
      of oxidative stress and inflammation among childhood acute lymphoblastic leukemia survivors.
    

Detailed description: 
      Acute lymphoblastic leukemia (ALL) is the most common childhood cancer, accounting for 25% of
      all childhood malignancies. Treatment of childhood ALL has a high success rate, with
      long-term event-free survival of >85%. Treatment success, however, has not come without cost.
      Recognition of long-term health problems related to childhood cancer therapies is growing.
      Both during and after therapy, children treated for ALL are at risk for fatigue, reduced
      physical activity, poor dietary intake, and excessive weight gain, which are driven by
      physiological (chemotherapy-induced) changes and social (home/environmental) factors. The
      goals of this pilot study are to evaluate the feasibility, acceptability, and potential
      efficacy of a parent-targeted, phone-delivered nutrition and physical activity program to
      prevent unhealthy weight gain among 60 childhood ALL survivors, 4-10 years of age.
      Participants will be randomly assigned to either the phone-delivered parent-targeted
      nutrition and physical activity intervention or a standard-of-care control group.
      Intervention success will be benchmarked by changes in key weight-related behaviors (physical
      activity and dietary intake) over the 6-month trial, and initial impact of the intervention
      on biomarkers of inflammation and oxidative stress, fatigue, and body composition will be
      examined.
    

Intervention name(s): Phone Coaching Program
Intervention type(s): Behavioral
Intervention description(s): Participants in this group will receive a 10-session nutrition and physical activity program delivered via phone by a health behavior coach to promote healthy lifestyle changes. Participants will also receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Biomechanical Correction in Medial Tibiofemoral Joint Osteoarthritis
Condition: Osteoarthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Effect of Biomechanical Correction of Tibia on Medial Joint space loading, Varus deformity
      and functional tasks in patients with medial tibiofemoral joint osteoarthritis in which
      participants will be taken. The outcome measures taken are Trauma CAD Software, NPRS, WOMAC
      and Goniometery will be measured at the baseline after 3rd week of the intervention.
    

Detailed description: 
      Background: Knee osteoarthritis (KOA) are very prevalent chronic disease of the joint which
      causing the functional disability and pain specifically in older adults.

      Objective: Purpose of the study is to see that the biomechanical correction on the tibia and
      varus deformity is effective in the conventional treatment of participants with the KOA.

      Study Design: A Randomized single group Pretest-Post test Clinical Trial. Methodology: Total
      '5' subjects were included in the study with the age of 40 to 60 years based on exclusion and
      inclusion criteria. For the pain, the NPRS will be taken, goniometer taken for the
      measurement of range of motion, WOMAC will be taken for the physical activity measurement and
      CAD Software will be taken to see the alignment of the affected limb. Conventional treatment
      will also be given.

      Conclusion: Biomechanical correction shows the significant improvement and improves the
      subject's physical activity and reduces the pain and stiffness.

      Keywords: Obesity, Osteoarthritis, Pain and Physical therapy modalities
    

Intervention name(s): Biomechanical corrections; Conventional Physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Biomechanical corrections is to be done to correct the varus deformity of knee joint and for pain management.; Conventional therapy includes Hydrocollatoral pack for 20 minutes, Interferential therapy for 15 minutes beat frequency 100 Hz, Sweep frequency 150 Hz and exercise program of 3 sessions for 20 minutes on alternative days for 3 weeks for management of knee osteoarthritis.
Intervention model: Single Group Assignment
Intervention model description: Single Group pre-test, post-test design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Osteoarthritis; Physical Therapy Modalities
Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Parkinsonian Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the brain uptake of 18F- DTBZ in 20 patients with PD, 20 patients
      with MSA, 20 patients with PSP, 20 patients with CBS, and 20 patients with VaP, 20 patients
      with ET, and 10 patients with DT.
    

Detailed description: 
      Study duration is expected to be completed in a period of 4 year. This study is a
      uncontrolled, open-label, non-randomized, parallel, and cross-sectional study. Total 130
      subjects, including 20 patients with PD, 20 patients with MSA, 20 patients with PSP, 20
      patients with CBS, 20 patients with VaP, 20 patients with ET, and 10 patients with DT, will
      be enrolled.

      Each evaluable subject involved in this study must fulfill all the inclusion and exclusion
      criteria according the subject grouping, each subject will have 3 visits in this study, as
      one screening visit, one imaging visit, and one safety evaluation visit.

      Safety measurement will be evaluated by medical history, vital signs, physical examinations,
      laboratory examinations and collecting of adverse events.
    

Intervention name(s): 18F-DTBZ
Intervention type(s): Drug
Intervention description(s): During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-DTBZ immediately prior to imaging.
The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 18F-DTBZ
Bioavailability of BIBR 953 ZW in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the extend of absorption of 12.5, 25, 50 and 100 mg of BIBR 1048 free base with and
      without coadministration of 40 mg pantoprazole.
    


Intervention name(s): BIBR 1048 low1; BIBR 1048 low2; BIBR 1048 medium; BIBR 1048 high; Pantoprazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Pantoprazole; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Apico-coronal Position of the Implant in Edentulous Diabetics With Implant-retained Overdentures
Condition: Diabetes Mellitus; Dental Implants
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      Diabetes Mellitus (DM) is a recognized factor affecting implant complication rates, including
      peri-implantitis and peri-implant bone loss, and the apico-coronal position of implants seems
      interfere on the conditions of peri-implant tissues. However, the influence of the vertical
      implant position in type 2 diabetics (T2DM) is unclear. This split-mouth randomized
      controlled trial evaluated the impact of implants of machined-collar placed at crestal level
      or supracrestally in T2DM rehabilitated with implant-retained overdentures on the clinical,
      tomographic and immunoinflammatory peri-implant outcomes after implant loading.
    

Detailed description: 
      Considering the outcomes achieved with implants with machined-collar inserted supracrestally,
      it would be relevant to investigate whether this therapeutic strategy could be considered as
      a more effective approach in the rehabilitation with dental implants of individuals with type
      2 DM, since these patients may be more disposed to peri-implant changes, both from the point
      of view of marginal bone remodeling as related to local variations in immunoinflammatory
      response. Thus, the propose of this split-mouth randomized controlled trial was to compare
      the impact of crestal level or supracrestally implant platform in T2DM rehabilitated with
      implant-retained overdentures on the clinical, tomographic and immunoinflammatory
      peri-implant outcomes after implant loading.
    

Intervention name(s): Dental Implant Placement and subsequent prosthetic reabilithation
Intervention type(s): Device
Intervention description(s): Surgeries to dental implant placement were performed. All patients received 3.5 mm diameter dental implants - surface blasted with TiO2 particles and machined collar of 1mm - in the interforaminal region of the mandible. The surgical sequence followed the protocol described by the implant company.A two stages protocol was used and the prostheses were placed at 4 months.The prosthetic retention system used in rehabilitation with overdentures was the O'ring and the capture of this component was done directly in the patient's mouth. After 7 and 14 days, the patients returned to occlusal adjustments and verification of prosthetic adaptation. The prostheses were made entirely of acrylic resin without metallic reinforcement and the antagonist of the patients were total edentulous and rehabilitated with muco-supported prostheses.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This study was designed as a prospective, split-mouth, randomized controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: dental prosthesis; biological markers; dental implants
the Effect of Instructional Method on Decision Making
Condition: Pregnancy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In these single- blind clinical trial 67 primigravida females, gestational aged 34-36 week
      were selected using multi-stage sampling and assigned into two groups randomly.
      Decision-making (before, two weeks after and at admission in maternity department) was tested
      by a researcher -made questionnaire. In experiment group, advantages and disadvantages of
      normal delivery and cesarean-section delivery were presented by role-playing in three 90-min
      scenarios. It was also presented in a 90-min lecture. Data were analyzed using SPSS by mean
      difference test, exact fisher test, independent t-test and paired t-test.
    


Intervention name(s): role play; lecture
Intervention type(s): Other; Other
Intervention description(s): In this method, researcher with two other co-researchers played 3 scenarios in 7 steps (for each scenario)including warm up, selecting participant, preparing the scene, preparing observers, play ,discussion and evaluation and generalization to education about advantages and disadvantages of normal delivery and cesarean section.; Describe advantages and disadvantages in one 90-min session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Lecture; Role-playing; Knowledge; Attitude; Decision making; Type of delivery
SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation
Condition: Lumbar Vertebra Hernia
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether SI-6603 is effective in the treatment of
      lumbar disc herniation.
    


Intervention name(s): SI-6603; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.; Placebo is administrated into the nucleus pulposus of an intervertebral disc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chemonucleolysis; Lumbar Vertebrae; Hernia
Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional

Summary: 
      This study was conducted to investigate the effects of daily supplementation of Red Ginseng
      Concentrated Powder on Improvement of Blood Triglyceride Level.
    

Detailed description: 
      This study was a 12-week, randomized, double-blind, placebo-controlled 2x2 cross-over design
      human trial. 50 subjects which of 25 by group were randomly divided into Red Ginseng
      Concentrated Powder and a placebo group.(A total of 100 subjects completed the 2x2 cross-over
      study.)
    

Intervention name(s): Red Ginseng Concentrated Powder; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.; Placebo for 12 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Red Ginseng Concentrated Powder; Hyperlipidemias; Clinical Trial
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)
Condition: Mildly Hypercholesterolemic Subjects
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect on cholesterolemia profile of a low
      fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in
      mildly hypercholesterolemic people treated or not by statins.
    


Intervention name(s): 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test); 2-Low fat fermented dairy product (control)
Intervention type(s): Other; Other
Intervention description(s): 1 = Intervention 1 (2 test products / day); 2 = Intervention 2 (2 control products/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Plant sterol - Cholesterol absorption - diet - dairy - LDL
A Phase 1 Study of HBI-3000
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 randomised, double-blind, placebo-controlled, serial cohort,
      dose-escalation study in healthy adult volunteers. It is planned to enroll 5 cohorts (Cohorts
      A to E) of 8 subjects. Up to 2 additional cohorts (Cohorts F and G) may be enrolled as needed
      to establish the safety profile of HBI-3000 over a clinically relevant range of doses.
      Subjects will be randomly assigned to receive a single dose of HBI-3000 or matching placebo
      in a sequential escalating manner (Regimens A to E and optional Regimens F and G), with a
      minimum of 7 days and a maximum based on logistics of interim review between dose groups.

      As a safety precaution, in each cohort a sentinel dosing group of n = 2 (1 active:1 placebo)
      will be dosed at least 24 h ahead of the main group. Safety and tolerability will be assessed
      by the principal investigator or medically-qualified designee before continuing with dosing
      the remaining subjects. The first 2 subjects will be allocated to active or placebo in a 1:1
      ratio. The remaining 6 subjects will be allocated to active or placebo in a 5:1 ratio.

      Doses of HBI-3000 may range from 20 mg to a level at which it is expected that the drug
      exposure will not exceed an AUC(0-t) of 20 μg.h/mL and Cmax of 20 μg/mL (based on the
      no-observed-adverse-effect levels [NOAEL] in both 14 day repeat dose toxicology species the
      rat and minipig) and the expected therapeutic dose range. Following administration to each
      cohort, there will be an interim data review during which the PK and safety data will be
      reviewed to determine the dose to be administered in the next cohort. Dose escalation for
      serial cohorts will progress unless safety concerns preclude further dose escalation. If the
      selected dose does not provide the required data, a previously tested dose may be used in a
      subsequent cohort. However, if the dose level met the dose escalation stopping criteria, that
      dose level must not be repeated. A previously untested intermediate dose may also be used in
      a subsequent cohort.
    


Intervention name(s): HBI-3000; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Small molecule, multi-ion channel blocker; Normal Saline
Other intervention name(s): Sulcardine sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cornual Wedge Resection Outcome
Condition: Ectopic Pregnancy; Laparoscopic; Cornual Pregnancy
MeSH terms: Pregnancy, Ectopic; Pregnancy, Cornual
Study type: Observational

Summary: 
      Cornual pregnancy is a rare form of ectopic pregnancy that accounts for 2% to 4% of ectopic
      pregnancies, with a mortality rate between 2.0% and 2.5%. Traditionally, interstitial
      pregnancies were treated by laparotomy with cornial resection or hysterectomy. However,
      nowadays, increasingly interstitial pregnancies are treated by laparoscopic cranial
      resection.

      Although this technique can potentially protect the fertility of the patient, it carries a
      serious risk of bleeding and requires a surgical experience.
    


Intervention name(s): laparoscopic cornual resection
Intervention type(s): Procedure
Intervention description(s): patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        postoperative results of patients who underwent laparoscopic cornual resection for cornual
        ectopic pregnancy, Patients forming the study group will be operated in the center for the
        last 3 years.