bioihbjkbjnl/mcl2 huggingface dataset:
3D Evaluation of Facial Swelling Post Impacted Lower Third Molars Surgery: RCT
Condition: Swelling/ Edema; Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted; Edema
Study type: Interventional

Summary: 
      Aim of the study is to evaluate the swelling following the osteotomy when performed with
      drilling bur versus piezo-electric instrument in the mandibular impacted third molar
      extraction, using a facial reconstruction software
    


Intervention name(s): Piezo-electric surgery of impacted lower third molars; Rotary bur surgery of impacted lower third molars
Intervention type(s): Procedure; Procedure
Intervention description(s): During lower third molar surgery, osteotomy is performed using piezoelectric instrumentation.
When necessary, tooth sectioning was performed with a high-speed tungsten carbide slit drill under saline irrigation and the tooth removed in single or multiple segments.; During lower third molar surgery, osteotomy is performed using rotary instruments
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split-mouth model
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: piezosurgery; conventional osteotomy; impacted lower third molar; facial scan; 3d rendering
A Study to Compare MP-513 20mg & Metformin XR 1000mg FDC With Coadministration of the Two Separate Drugs
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and pharmacokinetic characteristics of
      fixed-dose combination of MP-513 20mg and Metformin XR 1000mg with coadministration of the
      two separate drugs in healthy male volunteers.
    

Detailed description: 
      1. Randomized, Open-label, Single-dosing, Two-treatment, Two-sequence, Two-period,
           crossover design

        2. Wash-out period : 14days from the first dosing

        3. Drug concentration analytical device : UPLC-MS/MS
    

Intervention name(s): FDC(MP-513 20mg/Metformin XR 1000mg); MP-513 20mg; Metformin XR 1000mg
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): HL1351; Tenelia 20mg; Glucophage XR 1000mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica
Condition: Contraception Behavior
Study type: Interventional

Summary: 
      The primary hypothesis is that the intervention video - based on strategies from cognitive
      psychology - can correct women's misinformation about long-acting reversible contraception
      (LARC) and result in higher use of LARC. While there are no direct benefits to participants
      from being in the study, the research could benefit women in general by providing evidence to
      help prevent unintended pregnancy. Unlike many interventions that are not feasible for
      scaling up once shown to be effective in changing people's behavior, the proposed
      intervention has been carefully designed to impose a low burden to clinic staff and require
      few resources for translating to wider use. Thus, the investigators expect the intervention
      to have high potential for influencing clinical care and research for addressing the overall
      goal of reducing unintended pregnancy.
    

Detailed description: 
      The investigators will conduct a randomized trial (RT) of consenting adult women (N=220) to
      test the effectiveness of the final intervention video.

      Participants in the RT will complete the "Enrollment Questionnaire" and then will be
      randomized to either watch a short video on 1) debiasing about LARC safety (intervention arm;
      n=110) or 2) vector control (control arm; n=110) (Figure 2). Participants then will have the
      option of receiving routine contraceptive services that follow standard care. After three
      months, trained interviewers will contact participants to administer the short "Follow-up
      Questionnaire" via telephone. To corroborate participant reporting of contraception use
      during follow-up, the investigators also will extract data on LARC use from participant
      medical records.
    

Intervention name(s): Intervention video; Control video
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention video will employ the debiasing strategies. It will avoid directly articulating contraception-related myths, but instead will provide a limited number of alternative explanations related to IUD and implant safety.; The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate whether and to what extent
      co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of
      BI1015550, i.e. to compare the relative bioavailability of 6 mg BI 1015550 when given alone
      (reference, treatment R) to the relative bioavailability of 6 mg of BI 1015550 given on the
      4th day of a 12-day-treatment with itraconazole (test, treatment T) following oral
      administration in healthy male subjects.
    


Intervention name(s): BI 1015550; itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Reference and Test Treatment; Test treatment
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates
Condition: Hypoxic Encephalopathy; Birth Asphyxia; Neonatal Encephalopathy; Hypothermia, Newborn
MeSH terms: Brain Diseases; Hypoxia, Brain; Asphyxia Neonatorum; Hypothermia; Asphyxia
Study type: Interventional

Summary: 
      Studying the effect of passive versus Blanket roll III modality of therapeutic hypothermia
      (TH)on myocardial function of asphyxiated neonates through using tissue Doppler (TD).
    

Detailed description: 
      A clinical trial study of 100 Gestational-age-matched asphyxiated cooled neonates will
      divided into two groups, 50 in each group for comparison the myocardial function using
      passive cooling and BLANKET ROLL III as modality of TH.
    

Intervention name(s): Passive cooling application; cooling using Blanket roll III
Intervention type(s): Device; Device
Intervention description(s): Passive cooling application for asphyxiated neonates and their effect on myocardial function and hemodynamics; standard care using Blanket roll III in asphyxiated neonates and their effect on myocardial function and hemodynamics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: therapeutic hypothermia; asphyxiated neonates; tissue Doppler
Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering
      effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid
      and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid
      dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600
      mg of aliskiren. This study is being conducted to support monotherapy registration of
      aliskiren for the treatment of hypertension in children 6-17 years of age.
    


Intervention name(s): Aliskiren (6.25/12.5/25 mg); Aliskiren (37.5/75/150 mg); Aliskiren (150/300/600 mg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the low dose arm, participants used one or more of the 6.25 mg capsule (containing 2 minitablets) once daily to reach the body-weight stratified dose of aliskiren.; Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the medium dose arm, participants used one or more of the 37.5 mg capsule (containing 12 minitablets) once daily to reach the body- weight stratified dose of aliskiren.; Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the high dose arm, participants used one or more of the 150 mg capsule (containing 48 minitablets) once daily to reach the body- weight stratified dose of aliskiren.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pediatric hypertension; primary hypertension; secondary hypertension
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K
Condition: Healthy Subjects; Pharmacokinetics of ASP015K
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to explore safety and tolerability of single ascending doses of
      ASP015K, establish the maximum tolerated dose, and determine the pharmacokinetics and
      pharmacodynamics in healthy volunteers.
    

Detailed description: 
      Subjects will be confined to the clinical research unit for five days. Some subjects will
      participate in two confinement periods. Subjects will receive a follow-up phone call to
      assess safety seven days after the administration of the single dose of study drug.

      Subjects will be assigned to one of nine sequential groups A, B, C, D, E, F, G, H, or I. In
      each group, 6 subjects will be randomized to ASP015K and 2 subjects will be randomized to
      placebo. Subjects in group F will participate in two treatment periods. Subjects in the first
      treatment period of group F will have a single study drug dose administered in the fasted
      state. Subjects in the second treatment period of group F will have a single study drug dose
      administered immediately following a standard FDA recommended high-fat breakfast.
    

Intervention name(s): ASP015K; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Intervention MeSH terms: Peficitinib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: ASP015K; Healthy subjects; Pharmacodynamics; Maximum tolerated dose
Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      The incidence of gestational diabetes mellitus (GDM) is increasing. GDM requires patients to
      test their blood glucose at least four times daily. The investigators propose to
      prospectively evaluate blood glucose testing done every day compared to every other day. The
      primary goal is to establish the most cost-effective modality while still being able to
      detect patients who require therapy in a timely fashion. The investigators plan to evaluate
      this new management scheme utilizing a non-inferiority trial design.

      The investigators primary research question is the following: When managing patients with
      GDM, is every other day blood glucose testing non-inferior compared to every day blood
      glucose testing, as measured by the difference of less than 5% in birth weight?
    

Detailed description: 
      This study is a prospective randomized, non-inferiority clinical trial of pregnant women
      diagnosed with gestational diabetes. Patients with GDM diagnosed between 20 weeks 0 days and
      32 weeks 0 days of gestation will be recruited. Diagnosis of GDM will be based on Carpenter
      and Coustan criteria for an abnormal 3-hr 100 gram oral glucose tolerance test, as currently
      supported by the American College of Obstetricians and Gynecologists (ACOG). Patients whose
      1-hr, 50 gram oral glucose challenge test exceeds 200 mg/dl will not require a 3-hr oral
      glucose tolerance test (OGTT). If the patient meets the inclusion and exclusion criteria
      listed below, she will be offered participation in the trial and randomized to every day
      blood glucose testing or every other day blood glucose testing for the remainder of her
      pregnancy.

      After the diagnosis of GDM, and before recruitment to the study, all patients will be
      provided counseling and education and will attempt adequate blood glucose control with
      medical nutritional therapy alone for one week. During this period, all patients will test
      their blood glucose values daily. Only after this week is completed will a subject be
      approached for participation.
    

Intervention name(s): Blood glucose testing
Intervention type(s): Behavioral
Intervention description(s): Patients will be assigned either to blood glucose monitoring done every day (during a fasting state and 2 hours after breakfast, lunch and dinner) continued throughout gestation or to blood glucose monitoring done every other day with the same timeframes outlined above.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: glucose monitoring; gestational diabetes
Comparison of Extra-Virgin and Refined Olive Oil on Some Cardiovascular Risk Factors
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      Consumption of extra-virgin olive oil has beneficial effects on cardiovascular risk factors.
      The purpose of this study is to compare the effects of extra-virgin olive oil and refined
      olive oil, in adjunct to conventional medical treatment, in improving liver enzymes, plasma
      lipid profile and inflammatory markers in patients with cardiovascular risk factors.
    

Detailed description: 
      A randomized placebo controlled clinical trial will be conducted in Rajaie Cardiovascular
      Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation
      of the design of the study, written consent form will be completed. The participants are 40
      eligible patients, aged 20-75 years. Intervention group will be received 25 mL/d extra-virgin
      olive oil and control group will be received 25 mL/d refined olive oil for 6 weeks. Fasting
      blood sample will be taken to measure lipid profile, liver enzymes and inflammatory markers
      (Interleukine-6 [IL-6] and Interleukine-10 [IL-10] and C-Reactive Protein [CRP]).
    

Intervention name(s): Extra-Virgin Olive Oil; Refined Olive Oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily consumption of 25 mL Extra-Virgin Olive Oil in adjunct to medical treatment for 6 weeks; Daily consumption of 25 mL Refined Olive Oil in adjunct to medical treatment for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Music Therapy for People With Schizophrenia and Relates Psychosis.
Condition: Schizophrenia; Psychosis
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      Treatment of symptoms, rehabilitation of cognitive deficits, improvement of social
      functioning and quality of life in schizophrenia and other psychoses are approached through a
      comprehensive strategy that combines psychopharmacology with psychosocial interventions.
      However, despite the efficacy of these interventions, this is not the same in all patients,
      and a large percentage do not achieve functional recovery.
    

Detailed description: 
      The aim of this research is to carry out a randomized trial on the effects of a music therapy
      (MT) program, implemented in addition to the usual pharmacological and psychosocial
      rehabilitation (TAU), on symptoms, self-esteem, internalized stigma, social cognition, social
      functioning and the quality of life in these patients.
    

Intervention name(s): Music therapy and treatment as usual
Intervention type(s): Behavioral
Intervention description(s): The session-based intervention programme was designed with an integrated and multimodal perspective of music therapy [37], which allows the combination of active and passive activities together with focuses and perspectives based on empirical evidence [38]. It was implemented using a process-based approach, adapting content to different phases in the process: initial contact, managing resistance, confidence building, relationships, awareness, and closure. The central focus is on the patient and to adapt and remain flexible in the sessions in accordance with the capabilities and needs of the group members. Different perspectives are integrated via nonverbal communication. The layout and any changes to the setting are made in a gradual way in keeping with the process to foster feelings of security and belonging. Sessions begin with a brief period of breathing which then moves into warming-up and free-expression using instruments, followed by the central activity and the closure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Music Therapy; Psychosis; Adjunct Therapy; Psychosocial Rehabilitation; Recovery
Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery
Condition: Myocardial Ischemic Reperfusion Injury; End Stage Heart Disease; Heart Failure; Cardiomyopathy
MeSH terms: Heart Diseases; Cardiomyopathies; Reperfusion Injury; Myocardial Reperfusion Injury; Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether remote ischemic preconditioning with
      postconditioning (RIPC+RIPostC) reduces myocardial injury and improves clinical outcomes in
      heart transplantation surgery.
    


Intervention name(s): RIPC+RIPostC; control
Intervention type(s): Procedure; Procedure
Intervention description(s): Four 5 min cycles of upper limb ischemia and reperfusion by a cuff inflated to 200 mmHg, twice (after anesthesia induction and before surgery started, at 20min after aortic declamping); a deflated cuff placed on the right upper arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
A Study of Multiple Oral Doses of IX-01 in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of IX-01 after
      multiple doses, and to determine the PK of IX-01 and activity of CYP3A4.
    


Intervention name(s): Placebo; IX-01
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
the Effect of Endometrial Compaction Caused by Progesterone Effect on Pregnancy Outcomes
Condition: Infertility; Female Infertility; Frozen-thawed Embryo Transfer
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      The purpose of this prospective cohort study is to assess the effect of endometrial
      compaction caused by progesterone effect on pregnancy outcomes
    

Detailed description: 
      For a pregnancy to occur, the embryo must implant in a receptive endometrium during the
      window of implantation, which is thought to occur from day 22 to 24 of an idealized 28-day
      cycle. Early studies have suggested that assessing endometrial thickness with the use of
      ultrasound may be an alternative to invasive techniques such as endometrial biopsy for
      attempting to determine a receptive endometrium for frozen-thawed embryo transfer (FET).

      A preovulatory endometrial thickness of 7 mm or more is considered to be the cutoff for
      endometrial receptivity, below which many physicians would cancel an embryo transfer.
      However, in most studies in the literature, endometrial thickness was measured either on the
      day of hCG in fresh embryo transfer cases or on the last day of estrogen treatment in thawed
      embryo transfers. There are a limited number of studies evaluating the luteal period, embryo
      transfer day and endometrial thickness.

      Accordingly, in this prospective cohort study is to assess the effect of endometrial
      compaction caused by progesterone effect on pregnancy outcomes
    

Intervention name(s): Progesterone
Intervention type(s): Drug
Intervention description(s): ultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.
Other intervention name(s): Diagnostic Test: Blood test Measurement of E2, P4, LH, FSH hormones Diagnostic Test: Transvaginal
Intervention MeSH terms: Progesterone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women underwent frozen embryo transfer
      
Keywords: infertility; female infertility; frozen- thawed embryo transfer; female