bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Efficacy of EZC Pak in Adults With Upper Respiratory Infection (URI)
Condition: Common Cold
MeSH terms: Respiratory Tract Infections; Common Cold
Study type: Interventional

Summary: 
      A randomized-controlled interventional clinical trial to evaluate the effectiveness of EZC
      Pak & EZC Pak+D for the treatment of the common cold and/or a URI.
    

Detailed description: 
      This is a randomized-controlled interventional treatment study with three arms of comparable
      demographics to evaluate the efficacy of PPC Pharmaceuticals EZC Pak (& EZC Pak+D) to improve
      the severity and duration of the common cold or a URI in individuals. It is hypothesized that
      study participants will experience a positive impact on the duration and severity of their
      cold/URI while using EZC Pak (&EZC Pak+D). The second study objective is to examine if
      patients are accepting the test product as an alternative to antibiotics.
    

Intervention name(s): EZC Pak; EZC Pak +D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): After the onset of common cold symptoms, participants will take one pill (EZC Pak) each day for a period of 5 days.; After the onset of common cold symptoms, participants will take one pill (EZC Pak +D) each day for a period of 5 days.; After the onset of common cold symptoms, participants will take one pill (Placebo) each day for a period of 5 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Multi-national Study to Identify Treatment Discontinuation Rate in de Novo Alzheimer's Disease Patients Who Have Been Newly Prescribed With Donepezil (Aricept) in Asia (ADOS)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      This study is an observational study conducted prospectively under routine clinical setting
      for 1 year with about 700 patients diagnosed as Alzheimer's disease who will be treated by
      donepezil (Aricept) as monotherapy. The subjects will be recruited in the selected
      institutions of about 8 countries in Asia.
    

Detailed description: 
      Participation in this study places no additional visit schedule, which will be determined by
      the investigator's judgment based on the disease progression of each subject. Investigators
      educate subjects to keep decided visit schedule, and collect the required information for
      case record from (CRF) on the visit.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Alzheimer's disease patients who have been recently prescribed with donepezil (Aricept) as
        monotherapy for the first time
      
Keywords: Alzheimer's disease
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
Condition: Contraception
Study type: Interventional

Summary: 
      The purpose of this study is to see if inserting misoprostol in the vagina or between your
      cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a
      baby makes it easier and less painful.
    

Detailed description: 
      Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in
      the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous
      women. The cervix of a nulliparous woman has a smaller diameter and can lead to more
      difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause
      cervical dilation, some family planning providers use this drug to facilitate insertion.
      While there is a wealth of data on the use of misoprostol prior to many procedures requiring
      cervical dilation there is minimal objective evidence assessing its effect on provider ease
      of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project
      is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous
      women eases insertion and decreases pain. The results of this trial will be contributed to a
      prospective meta-analysis on the subject.
    

Intervention name(s): Misoprostol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion.; Pills which are identical to the study drug in appearance, taste, and smell.
Other intervention name(s): Cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: IUD insertion; Nulliparous women; Contraception; Family Planning; IUD insertion in nulliparous women
Long-term Follow-up Study of the truSculpt Radiofrequency Device for Circumferential Reduction
Condition: Abdominal Fat
Study type: Observational

Summary: 
      A long-term follow-up study to evaluate the safety and efficacy of the Cutera truSculpt
      radiofrequency device for circumferential reduction.
    

Detailed description: 
      The purpose of this investigation is to follow-up subjects who have completed participation
      in the Treatment Group of Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency
      Device for Circumferential Reduction" for the long-term (18 months) safety and efficacy of
      the truSculpt radiofrequency (RF) device for circumferential reduction in the abdominal and
      flank region.
    

Intervention name(s): truSculpt
Intervention type(s): Device
Intervention description(s): Device comparison of Circumference measurement at Baseline vs 18 months post treatment
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        14 Subjects from C-16-TS11 participants followed up for measurement
A Phase 2, Double-blind Study to Evaluate Intranasal Trivalent Influenza Virus Vaccine in Healthy Adult
Condition: Influenza Infection
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this phase 2 study are to evaluate immunogenicity, safety and tolerability
      of AD07030, a trivalent influenza virus antigens vaccine, given intranasally in 2 doses in
      healthy adult volunteers.
    

Detailed description: 
      This is a Phase 2 prospective, randomized controlled, double-blind, multi-center study to
      evaluate the immunogenicity, safety and tolerability of AD07030, a trivalent influenza virus
      antigens vaccine, given intranasally in healthy adult volunteers.

      About 358 healthy subjects, meeting all the eligibility criteria will be enrolled into the
      study and randomized into 3 study groups (in 2:2:1 ratio) to receive either the study vaccine
      at one of the dose levels of adjuvant AD07010 (30μg or 45μg LTh(αK)) in combination with
      hemagglutinin (HA) antigens or to receive control vaccine consisting of HA antigens alone.
      The 3 study groups are as follows:

        -  Group 1: 22.5μg HA with 30μg AD07010

        -  Group 2: 22.5μg HA with 45μg AD07010

        -  Group 3: 22.5μg HA alone Each subject will receive intranasal administration of 2 doses
           of IP (study or control vaccine) at same dosages, given 7 days apart on study Day 1 and
           Day 8. Solicited local and general AEs will be recorded after each vaccination in the
           subject's diary card for up to 7 days (the vaccine administration day and 6 days
           following it). Subjects will be followed up for monitoring of safety and immunogenicity
           for 180 days. AE and SAE and concomitant medication/vaccination will be collected
           throughout the study. There will be total of 6 study visits and a telephone call.
    

Intervention name(s): AD07010; Inactivated trivalent influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): A protein based adjuvant; Inactivated trivalent seasonal influenza vaccine
Other intervention name(s): LTh(αK); Escherichia coli heat-labile enterotoxin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: adjuvant; vaccine; mucosa; IgA; Escherichia coli Enterotoxin
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine
      sodium 300 μg tablets to Lloyd's Levothroid® 300 μg tablets following a single 600 μg (2 x
      300 μg) dose administered in healthy adult volunteers under fasting conditions. Statistical
      analysis of the data revealed that 90% confidence intervals were within the acceptable
      bioequivalent range of 80% and 125% for the natural log transformed parameters LNAUC0-48hr
      and LNCPEAK for baseline corrected total levothyroxine.
    


Intervention name(s): Levothyroxine Sodium Tablets 300 μg; Levothroid® Tablets 300 μg
Intervention type(s): Drug; Drug
Intervention description(s): 2x300mcg, single dose fasting; 2x300mcg, single dose fasting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Extracorporeal Shock Wave Therapy for Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      purpose of this study to investigate the effect of Extracorporeal shock wave therapy on pain
      and prostaglandin level in patient with primary dysmenorrhea
    

Detailed description: 
      This randomized controlled trial is to determine the effect of shock wave therapy in the
      treatment of primary dysmenorrhea.

      females are randomly assigned into 2 groups: group A SWT treatment plus dietary modification
      during PD (n=25） GROUP B:dietary modification only (n=25）;

      Participants in group B will receive dietary modification for three successive months

      The numerical rating scale (NRS) and prostaglandin blood level will be recorded and evaluated
      before and after treatment.
    

Intervention name(s): shock wave therapy; dietary modification
Intervention type(s): Other; Other
Intervention description(s): Intervention group is by shock wave therapy. A radial shock wave device (EME, ITALY) was used. for 4 sessions (one session before the expected day of period and session per day for day1 , day 2 and day 3 of each menstrual cycle) for three successive periods.; Participants will receive dietary modification for three consecutive months dietary modification will be low caffeine and high water and liquids intake and reduce the uptake of fast food, should be followed for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: group A: shockwave therapy and dietary modification group B: dietary modification
Masking: Single (Participant)
Primary purpose: Treatment
To Study the Effect of Investigational Product on Fatigue and Cardiorespiratory Fitness in Healthy Adults.
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      E-OJ-01 (Oxyjun®), a proprietary, standardized aqueous extract of TA, has been proven to
      improve cardiac output and thereby lead to better oxygenation capacity and exercise
      endurance.

      This, in turn, averts fatigue and improves physical functioning. Based on the previous
      studies of E-OJ-01 and the scientific literature available in support of the antioxidant and
      anti- inflammatory activity of TA bark, in the present study, it is hypothesized that E-OJ-01
      will be able to reduce fatigue and improve the cardiorespiratory fitness of the male
      participants aged between 30 to 60 years.
    


Intervention name(s): E-OJ-01; Microcrystalline cellulose
Intervention type(s): Other; Other
Intervention description(s): 1 capsule (400 mg) orally to be taken after breakfast daily for 60 days; 1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Parallel Group, Placebo Controlled Trial
Masking: Double (Participant, Care Provider)
Primary purpose: Other
A Study to Compare if the Uptake of Ticagrelor in the Body Differs When Different Tablets Are Administered
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the relative bioavailability of ticagrelor for the different formulations. A
      randomized cross-over design has been chosen to minimize the effects of between-subject
      variability and any period effects on the overall results.
    

Detailed description: 
      This study will be an open-label, randomized, 4-period, 4-treatment, cross-over,
      single-center, single-dose study to assess the relative bioavailability of different
      formulations of ticagrelor in approximately 44 healthy adult subjects. Eligible subjects will
      be healthy male and female aged 18 to 55 years, with a body weight of 55 to 100 kg and a body
      mass index (BMI) of 18 to 30 kg/m2. Of the 44 randomized subjects, at least 36 evaluable
      subjects should be at the end of the last treatment period. Subjects will be randomized to 1
      of 4 treatment sequences and will receive single oral doses of 4 different formulations of
      ticagrelor under fasted conditions. Subjects will fast for at least 10 hours prior to
      administration of Investigational Medicinal Products (IMPs). No fluids will be allowed apart
      from water which can be given until 1 hour prior to administration of the IMP and then from 2
      hours after administration of the IMP. A meal can be given 4 hours after administration of
      the IMP.
    

Intervention name(s): Ticagrelor granule; Ticagrelor pediatric tablets; Ticagrelor pediatric tablets suspended in water; Ticagrelor immediate release (IR) tablets (Commercial tablet)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A P2Y12 receptor inhibitor provided as granule for suspension.; A P2Y12 receptor inhibitor provided as pediatric tablets to be swallowed whole.; A P2Y12 receptor inhibitor provided as pediatric tablets suspended in water.; A P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (unstable angina, non-ST (S and T waves) elevation MI or ST elevation MI) and in patients with a history of MI
Other intervention name(s): Brilinta
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized cross-over design has been chosen to minimize the effects of between-subject variability and any period effects on the overall results.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Abnormal hemoglobin (called hemoglobin S or sickle hemoglobin) in the red blood cells; Thrombotic cardiovascular events; Acute coronary syndrome; P2Y12 platelet inhibitor; Brilinta
Investigation of the Effects of CGF and A-PRF on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery
Condition: Trismus; Edema; Pain; Post-Op Complication
MeSH terms: Trismus; Edema; Postoperative Complications
Study type: Interventional

Summary: 
      The objective of this case-control intervention study is to explore the effectiveness of
      Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) on Pain, Edema and
      Trismus After Impacted Lower Third Molar Surgery
    

Detailed description: 
      In the present study, 75 patient, whose ages ranged between 18-30 and have an impacted lower
      third molar which is in vertical or mesiyoangular position and has class I and II ramus
      relationship and class B and C depth, will included. 75 patient will divided randomly into
      three groups as CGF, A-PRF and Control. After third molar surgery CGF and A-PRF will prepared
      and applied to the extraction sockets in CGF and A-PRF groups. nothing will applied to the
      control group. Post operative pain, edema and trismus will measured at 2nd and 7th days.
    

Intervention name(s): Concentrated Growth Factor (CGF); Advanced Platelet Rich Fibrin (A-PRF); Control
Intervention type(s): Other; Other; Other
Intervention description(s): CGF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for CGF); A-PRF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for A-PRF); Nothing applied after extraction
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Perspective-taking, and Examining the Clinical Trial Informed Consent Process
Condition: Emotions; Informed Consent
Study type: Observational

Summary: 
      Background:

      - Very few people with cancer participate in clinical trials. Some are uncertain about the
      treatment, or are afraid of being treated like a guinea pig. They may also feel that they
      have inadequate information about the trial. One possible way of encouraging people to sign
      up for clinical trials is to improve the informed consent process. Researchers want to
      understand how people read and understand informed consent documents.

      Objectives:

      - To study perspective taking, and to study how people understand the information and
      enrollment process for a clinical trial.

      Eligibility:

      - Healthy volunteers at least 18 years of age.

      Design:

        -  This study will require one study visit.

        -  Participants will watch one of four movie clips. They will be asked to respond to the
           film by looking at it from the main character s perspective. They will then answer
           questions about how the clips made them feel.

        -  Participants will read a sample cancer clinical trial consent form on a computer. The
           computer will record their eye movements while they read the text. They will then be
           asked whether they remember the information in the consent form, and whether they would
           participate in the trial.

        -  No treatment will be provided as part of this study.
    

Detailed description: 
      This study aims to examine perspective-taking and emotional states. The study also aims to
      examine information processing in the context of clinical trial consent forms, perceptions of
      risk of study side effects, hypothetical intentions to enroll, and satisfaction with the
      consent review process. Adult human subjects will be randomly assigned to watch a movie and
      take the main character s. Participants will also be asked to read a consent form for a
      clinical trial. Finally, they will be asked a series of questions about the consent form. I
      have also attached changes to the lay summary, which I had previously submitted, just to make
      sure that you have them.
    

Observational model: Other
Time perspective: Prospective
Keywords: Emotion; Informed Consent
Effects of Low-Speed and High-Speed Resistance Training Programs on Frailty Status
Condition: Frailty
MeSH terms: Frailty
Study type: Interventional

Summary: 
      The present study refers to a three-arm randomized controlled trial that investigated the
      effects of two types of RT on frailty status, physical performance, cognitive function, and
      blood pressure of prefrail and frail older adults.
    


Intervention name(s): Physical Exercise
Intervention type(s): Behavioral
Intervention description(s): Exercise interventions were carried out over a total of 16 weeks in the mornings (08:00 am-12:00 am) under the supervision of at least two fitness instructors. Participants performed four exercises for lower limbs (Figure 9): 1st) squat on the chair, 2nd) seated unilateral hip flexion, 3rd) seated unilateral knee extension, and 4th) bilateral calf raise with 12-15 submaximal repetitions avoiding fatigue (i.e., inability to complete a repetition in a full range of motion). The number of sets was increased linearly during the first month, such that one set was performed in the 1st week, two sets in the 2nd week, 3 sets in the 3rd week, and 4 sets in the 4th week. Subsequently, participants performed the main exercise period. After a brief warm-up, participants performed the same exercises that were performed during the familiarization period using an adjustable weight vest and ankle weights (DOMYOS®, Shangai, China).
Other intervention name(s): Resistance Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS)
Condition: ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the safety and the efficacy of perampanel in patients with sporadic
      amyotrophic lateral sclerosis
    

Detailed description: 
      To evaluate the effect of peramanel for 48 weeks on progression of disease in subjects with
      ALS, as measured by ALS Functional Rating Scale-Revised (ALSFRS-R)
    

Intervention name(s): Perampanel; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4mg/d or 8mg/d; placebo
Other intervention name(s): non-competitive AMAP antagonist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sporadic ALS; perampanel