bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to
      Assess the Relative Bioavailability of PT010
    

Detailed description: 
      A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to
      Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With
      and Without Oral Charcoal
    

Intervention name(s): Regimen A; Regimen B; Regimen C; Regimen D
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure; 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure; 2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure; 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD
Study Of GW679769 In Major Depressive Disorder
Condition: Depressive Disorder, Major; Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of
      GW679769 in subjects with major depressive disorder.
    


Intervention name(s): GW679769
Intervention type(s): Drug
Intervention MeSH terms: Casopitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Major Depression; Mood Disorders; Major Depressive Episode
Smart Box With OT Equator Attachment in Retaining Implant-assisted Overdenture for the Atrophic Maxilla.
Condition: Atrophic Maxilla; Edentulous Jaw
MeSH terms: Jaw, Edentulous; Atrophy
Study type: Interventional

Summary: 
      The aim of the present study is to clinically and radiographically evaluate the effect of the
      use of recently developed Smart Box accompanied with OT Equator attachment in retaining of
      the inclined implant assisted overdenture for atrophic maxilla and to compare the vertical
      bone changes around axial implants with OT Equator attachment and inclined implants with
      smart box attachment radiographically using CBCT
    


Intervention name(s): Implant assisted maxillary overdenture
Intervention type(s): Other
Intervention description(s): For each patient, an implant assisted maxillary overdenture will be fabricated using a minimally invasive flapless surgical technique with OT-Equator and Smart Box attachment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Teenage Pregnancies in Refugee and Migrant Adolescents on the Thai-Myanmar Border
Condition: Teenage Pregnancy
Study type: Observational

Summary: 
      This study is to explore perceptions, experiences, beliefs and knowledge around teenage
      pregnancy, motherhood, sexual and reproductive health, family planning and support structures
      adolescent refugees and migrants and to identify demographic, social and medical
      characteristics of study participants.
    

Detailed description: 
      The study will be conducted as follows:

        -  12-24 individual interviews with pregnant or postnatal adolescent girls (<20 years);

        -  1 Focus group discussion of 6-10 non-pregnant female adolescents (<20 years);

        -  1 Focus group discussion of 6-10 adolescent men (<20 years);

        -  1 Focus group discussion of 6-10 Shoklo malaria research unit antenatal care staff;

      Interviews and focus group discussion will be conducted with study participants who agree to
      participate in discussions about teenage pregnancy and motherhood, sexual and reproductive
      health. In-depth interviews and focus group discussion will be conducted in private meeting
      rooms in proximity to the antenatal clinic waiting areas. In-depth interviews and Focus group
      discussion will be co-facilitated by the principal investigator and a trained
      counsellor/midwife fluent in Karen, Burmese and English. Focus group discussion will be run
      separately for Burmese- and Karen-speaking participants and participants will be separated by
      subgroup. Focus group discussion will include 6-10 participants per group and for each focus
      group discussion to last between 45-60 minutes. Individual in-depth interviews will last
      approximately 60 minutes each.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The participant will be adolescent mothers and non-pregnant adolescent aged 12 - <20 years,
        adolescent men aged < 20 years and ANC staff.
      
Keywords: Thai-Myanmar border
An Attempt at Translating Novelty-enhanced Extinction of Context Conditioning From Rodents to Humans
Condition: Healthy
Study type: Interventional

Summary: 
      In rodents, novel exploration has been used to strengthen the consolidation of a variety of
      hippocampal-dependent learning tasks. To our knowledge, no attempt have been made to
      translate the effect of strengthening the memory of an extinction of a context conditioning
      memory. This study uses virtual reality for both context conditioning and novel exploration
      in an attempt at translating these findings from rodents to humans, thus, using novel
      exploration to strengthen an extinction memory. Threat responses are measured with skin
      conductance and startle responses. If this effect could be shown experimentally in humans,
      that experimental setup could become an important tool in understanding important memory
      processes of fear, such as reconsolidation and behavioral tagging.
    

Detailed description: 
      The study employs healthy participants and includes three experimental sessions, roughly 24 h
      apart. During the first session, participants undergo context conditioning in virtual reality
      where the CS+ and CS- are two different rooms. During the second session, half of the
      participants perform an exploration of a novel virtual environment, and the other half
      performs a visual attention task. About 60 min later, participants undergo extinction to the
      context conditioning performed in session 1, again in virtual reality. In session 3,
      remaining threat responses are measured through a reinstatement procedure, again in virtual
      reality.
    

Intervention name(s): Novel Exploration; Threat conditioning; Extinction; Reinstatement; Visual attention control task
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Exploration of a novel 3D-environment in virtual reality.; Session 1. Threat conditioning to two different (CS+, CS-) virtual reality contexts (i.e rooms). One of these is paired with a mild electric shock. The context paired with the electric shock (CS+) is counterbalanced across participants. Participants are instructed that they may receive electrical shocks during the procedure.; Session 2. Participants are repeatedly exposed to the both contexts from session 1 (CS+, CS-), but no shocks are delivered.; Session 3. Participants are again repeatedly exposed to both contexts from session 1 (CS+, CS-), after a few shocks delivered in a neutral context.; Session 2. A visual attention task used as a control task instead of novel exploration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Threat conditioning; Virtual reality; Extinction; Behavioral tagging
Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere, France
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Observational

Summary: 
      This study evaluates the relation between sens of coherence and primary dysmenorrhea.
      Aself-questionnaire is completed by a sample of girls aged between 14 and 19, schooled in
      Finistère (France).
    

Detailed description: 
      Primary dysmenorrhea affects more than 60% of adolescent girls. Menstrual pain increases
      absenteeism and lowers self-esteem and academic performance. Moreover, dysmenorrheal women
      suffer more depression and anxiety.

      Sense of coherence (SOC) is composed of three items:

        -  comprehensibility: what the person understands about his illness

        -  manageability: what the person does to cope

        -  meaningfulness: what the disease means to the person. A high SOC score is related to
           good mental and physical health. The aim of this study will be to determine if there is
           a relationship between primary dysmenorrhea and the sense of coherence.

      A self-questionnaire composed of the SOC-13 and a scale evaluating dysmenorrhea will be
      proposed in the voluntary high schools of Finistère (France) to the girls of the classes
      chosen at random.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        High school girls in Finistère
      
Keywords: Sens of coherence; Primary dysmenorrhea; Salutogenesis; Teenagers
Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells
Condition: Hodgkin Disease; Non-Hodgkin Lymphoma; Multiple Myeloma; Bacteremia
MeSH terms: Bacteremia; Multiple Myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study investigates whether the prophylactic use of moxifloxacin during high-dose
      chemotherapy followed by autologous stem cell transplantation reduces the incidence of
      clinically significant bacteremia.

      Further investigations include time to occurrence of fever, duration of fever, overall
      survival and antibiotic sensitivity of blood isolates.
    

Detailed description: 
      Because fluoroquinolones have broad antimicrobial coverage, bactericidal activity, high
      tissue concentrations, oral bioavailability and adequate tolerability and safety profiles,
      they are ideal candidates as antibacterial prophylaxis in cancer patients. Randomized trials
      investigating the effect of an antibiotic prophylaxis on patients with intermediate
      neutropenia have recently been conducted with levofloxacin. The influence of moxifloxacin on
      the incidence of bacteremia in patients undergoing autologous hematopoetic stem cell
      transplantation has not been investigated. Moxifloxacin may be another promising alternative,
      covering a broader spectrum of gram-positive and anaerobic bacteria than first- or secondary
      generation fluoroquinolones and for instance it is an agent administered only once daily,
      thus optimizing compliance, a crucial issue in prophylaxis.
    

Intervention name(s): moxifloxacin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg p.o. per day; one tablet per day p.o.
Other intervention name(s): Avalox; placebo preparation
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: prophylaxis; bacteremia; moxifloxacin; stem cell transplantation; Hodgkin disease; non-Hodgkin lymphoma; multiple myeloma; solid tumor; autologous stem cell transplantation
Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC
Condition: COVID-19 Vaccine
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective is to determine the safety and immunogenicity of two different strengths (3 µg
      and 6 µg) of an inactivated COVID 19 Vaccine compared to placebo so that to demonstrate the
      safety and efficacy in prophylaxis of COVID-19.
    

Detailed description: 
      This is a double-blind, double dose, parallel, randomized vaccination study. Each subject
      will receive in random order a double intramuscular dose of ERUCOV-VAC 3 µg/0.5 ml Vaccine,
      ERUCOV-VAC 6 µg/0.5 ml Vaccine or 0.5 ml of placebo Vaccine according to a sequence
      determined by randomization, on Day 0 (1st vaccination) and Day 21 (2nd vaccination).In total
      34 healthy subjects of both genders will be monitored for one year in total, after Day 43 the
      study will be unblinded and the volunteers who took placebo vaccine will be released from the
      study. The most important evaluation will be performed on Day 43 after the first vaccine
      dose.
    

Intervention name(s): ERUCOV-VAC; Placebo Vaccine
Intervention type(s): Biological; Other
Intervention description(s): Vaccination on Day 0 and Day 21; Placebo Vaccination on Day 0 and Day 21
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: COVID-19; Inactive Vaccine; Phase I
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
Condition: Cataracts
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to determine if an extension of bromfenac BID monotherapy is
      effective in the decreasing retinal thickening post cataract IOL placement surgery. No
      studies exist on how long to treat with an NSAID post cataract IOL placement surgery.
      Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment,
      lasting approximately 3 weeks. This study is designed to examine if there is benefit to
      extending NSAID monotherapy in regards to macular thickening and the incidence of CME.
    


Intervention name(s): Bromfenac; Moxifloxacin hydrochloride; Prednisolone Acetate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks; Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.; Group 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD).
Other intervention name(s): Bromfenac (Xibrom); Moxifloxacin hydrochloride (Vigamox); Omni-Pred
Intervention MeSH terms: Moxifloxacin; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Bromfenac; Norgestimate, ethinyl estradiol drug combination; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Efficacy and Safety of Ramelteon on Chronic Insomnia
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the dose response of Ramelteon, once daily (QD), in
      Japanese subjects with Chronic Insomnia
    

Detailed description: 
      Complaints of sleep disorder are increasing with today's aging society and changing
      lifestyle. Sleep disorders not only impact one's activities of daily living, but also impede
      one's social life, leading to reduced productivity and sometimes accidents through
      carelessness.

      Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical
      Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for
      the treatment of Circadian Rhythm Sleep Disorders.
    

Intervention name(s): Ramelteon and Placebo (25 possible combinations total)
Intervention type(s): Drug
Intervention description(s): Randomized sequence over two consecutive nights for a total of five treatment periods to include the following:
Ramelteon 4 mg, tablets, orally over two nights
Ramelteon 8 mg, tablets, orally over two nights
Ramelteon 16 mg, tablets, orally over two nights
Ramelteon 32 mg, tablets, orally over two nights
Ramelteon placebo-matching tablets, orally over two nights
Other intervention name(s): Ramelteon; Rozerem; TAK-375
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Sleep Initiation and Maintenance Disorders; Drug Therapy
The mCME Project:Delivering Continuing Medical Education for Community Health Workers Via SMS Text Messages
Condition: Medical Knowledge
Study type: Interventional

Summary: 
      Community health workers (CHWs) provide essential basic medical care to hundreds of millions
      of people across the globe. CHWs offer a myriad of services including community sanitation,
      breast feeding counseling, family planning, management of febrile children, and malaria
      control and prevention, to name but a few. In fact, CHWs are often the only source of primary
      health care available to some of the most disadvantaged populations in the world. However, to
      be effective, CHWs must be trained - and retrained - at regular intervals, and the costs for
      such trainings can be substantial. In the US, clinicians are required to stay current and
      maintain their competence through continuing medical education (CME). Increasingly, CME
      activities are delivered via internet-based, self-teaching modules. A typical example would
      be a set of topical readings followed by multiple-choice questions, with the answers, and CME
      credit, provided to the user upon satisfactory completion of the module. This content is
      typically delivered over the Internet. However, there is no intrinsic reason why this
      approach could not be adapted so that CME activities are delivered using standard cell phones
      via SMS text messaging. This would significantly expand professional training opportunities
      to a far greater range of CHWs than possible through computer/tablet/smart phone platforms,
      and would be particularly valuable in poorer countries with limited training budgets. In the
      mCME project, the investigators propose to test the effectiveness and cost effectiveness of a
      mobile phone-based CME delivery strategy among Vietnamese community-based physician
      assistants (CBPAs), a cadre of CHW mandated to provide primary health care to rural and
      disadvantaged populations. The investigators hypothesize that providing CME activities over a
      mobile platform will significantly improve their professional knowledge, and may also improve
      their job satisfaction and self-efficacy.
    


Intervention name(s): Group 2 intervention daily SMS bullet point; Group 3 intervention daily SMS bullet point
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Group 2 subjects receive a daily SMS bullet point, summarizing a key clinical point pertinent to the CBPA's daily work.; Group 3 subjects receive a c phrased as a multiple choice question. The content mirrors that of group 2, but is presented as a question to render it interactive
Other intervention name(s): non interactive model CME; Interactive model CME
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Pre-Surgical Grading System of Asherman Syndrome
Condition: Asherman Syndrome
MeSH terms: Gynatresia; Syndrome
Study type: Observational

Summary: 
      Utilising a novel pre-surgical grading system to class cases of asherman syndrome into 3
      groups based on expected difficulty of surgery and potential prognostic outcomes.
    

Detailed description: 
      Using the grading system, patients are classified into Mild, Moderate and Severe Asherman
      Syndrome. With the mild disease having the best prognostic value and a 1 step procedure,
      Moderate cases having a mediocre prognosis and usually multi-step procedure and Severe cases
      having a poor prognosis and counseled to other options. This observational study looks at the
      surgical outcomes following hysteroscopy for cases graded according to the new system to
      identify the accuracy of the classification in predicting the surgical success and prognostic
      value.
    

Intervention name(s): Classification
Intervention type(s): Other
Intervention description(s): Novel Asherman Scoring Classification
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients complaining of hypomenorrhea, amenorrhea or infertility, who have a
        hysterosalpingography confirming intrauterine adhesions (Asherman Syndrome)
      
Keywords: Asherman Syndrome; Hysteroscopy; Intra-Uterine Surgery; Intra-Uterine Adhesions; Classification
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine
Condition: Type 1 Diabetes
MeSH terms: Autonomic Nervous System Diseases; Primary Dysautonomias; Hypoglycemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is aimed at determining if the drug Atomoxetine (Strattera-used to treat Attention
      Deficit Hyperactivity Disorder(ADHD) has effects on the body's ability to defend itself
      against low blood sugar.
    

Detailed description: 
      The purpose of this study is to see if the drug atomoxetine (Strattera) has effects on the
      body's ability to defend itself against low blood sugar. Normally, when blood sugar levels
      drop below normal, the body creates a series of responses, which increase the sugar inside
      the body to bring blood sugar levels back to normal. The hormone epinephrine is a key defense
      against low blood sugar in people with diabetes. Atomoxetine has been shown to increase this
      hormone level. Thus, any approaches to increase levels of this key defense during low blood
      sugar may have great value.
    

Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg oral dose, once per day for 6 weeks; 80 mg dose once per day for 6 weeks
Other intervention name(s): Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment