bioihbjkbjnl/mcl2 huggingface dataset:
Aspiration of Limited Number of Follicles to Prevent Severe Ovarian Hyperstimulation Syndrome
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of single ovarian puncture to retrieve
      7eggs only in prevention of severe ovarian hyperstimulation syndrome.
    

Detailed description: 
      Thirty patients will be selected for this study grouped into two groups, each group contains
      fifteen patients.

      Group 1 :study group ( retrieval of 7 eggs only). Group 2 :control group ( retrieval of all
      eggs). Study is held to compare between the two arms, the proportion of patients who will be
      prevented from the progression to severe OHSS after this interventional method.
    

Intervention name(s): 7 eggs collection; Full eggs collection
Intervention type(s): Procedure; Procedure
Intervention description(s): vaginal US; vaginal US
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Effect of Vitamin D and Denosumab on Bone Remodelling in Women With Postmenopausal Osteoporosis
Condition: Hypovitaminosis D; Osteoporosis, Postmenopausal; Menopause
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Rickets; Avitaminosis; Vitamin D Deficiency
Study type: Interventional

Summary: 
      Denosumab is a monoclonal antibody against RANKL ligand, which is used as an alternative
      treatment for osteoporosis in patients who have a poor response to first-line antiresorptive
      therapy. However, discontinuation of denosumab produces a rapid increase in bone turnover,
      bone loss and potentially increased risk of multiple vertebral fractures.
    

Detailed description: 
      76 postmenopausal women from the climacteric clinic of the regional hospital "1o de Octubre"
      of the Institute of Security and Social Services for State Workers (ISSSTE) were firstly
      considered, of which 23 presented elimination criteria and only 55 who had received denosumab
      therapy for an average of 2.5 years without a significant improvement in hip and lumbar spine
      T-scores were enrolled. First, a general medical evaluation was performed. Serum levels of
      vitamin D were analysed to find the prevalence of hypovitaminosis D. A bone mineral density
      test was done to calculate hip and lumbar spine T-scores. Then, vitamin D was administrated
      daily for one year at a dose of 4,000 IU and the studies were repeated after one year.
      Statistical analysis was performed using PAST 3.0 and GraphPad Prism 8.4.3. software. The
      arithmetic median (µ) and standard deviation (S.D.) were calculated using Excel-Word.
      Graphics were constructed with GraphPad Prism 8.4.3 and tables with Excel Word. Categorical
      variables were analysed with chi-squared or Fisher exact test depending on the number of
      participants in each cell. Normality was determined using the Shapiro-Wilk test. To compare
      two paired samples, the Wilcoxon signed-rank test was utilized. The assigned α value for this
      study was <0.05. In all cases, if a Montecarlo permutation was available, the exact p-value
      was taken instead of the raw p-value.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention description(s): 4000 IU were administrated once a day for 3 months.
Other intervention name(s): Histofil®
Intervention MeSH terms: Cholecalciferol; Vitamin D
Intervention model: Single Group Assignment
Intervention model description: 76 participants were considered from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE), of which 23 presented elimination criteria, and 55 were included in the study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vitamin D; Postmenopausal Osteoporosis; Denosumab; Hypovitaminosis D; Osteoporosis; Osteopenia
Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Adults
Condition: Smallpox
MeSH terms: Vaccinia; Smallpox
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to gather information on the safety and the effectiveness of an
      investigational vaccine for the prevention of smallpox disease. Smallpox was one of the major
      causes of death and sickness through the first half of the 20th century, but a global program
      of smallpox eradication resulted in the elimination of the natural disease. The last cases of
      smallpox in the United States occurred in 1949 in Texas. Today, only laboratory workers who
      work with smallpox-related viruses, military personnel, and health care workers are
      vaccinated.

      Historically, individuals in the US were vaccinated with a product such as Dryvax®, which
      contains the virus vaccinia in the same family as smallpox. This virus could promote immunity
      to smallpox, but not produce the disease itself. Although effective, these vaccines are not
      safe to use in people with atopic dermatitis (eczema, allergic immune response to allergens),
      children less than 1 year of age, and people with a compromised immune system, occurring in
      certain diseases (HIV positive individuals and AIDS), and following treatment with certain
      types of drugs. It is important to find a safe vaccine that can be used to protect people who
      cannot receive routine vaccinia-based smallpox vaccine.

      The vaccine in this study is known as Modified Vaccinia Ankara or MVA vaccine. It is the
      objective of this study to find out if MVA vaccine is safe and effective in providing
      immunity to smallpox. The effectiveness of this vaccine will be measured in two ways. The
      first way is to find out if there are specific antibodies in your blood following MVA
      vaccination. Antibodies are chemicals your body produces to fight smallpox virus.

      The second way is to see whether or not there is a typical skin reaction following
      vaccination with a traditional smallpox vaccine, given about three months after vaccination
      with the MVA vaccine. The typical reaction in an unvaccinated person to smallpox vaccine is
      formation of a blister or "pox" which occurs at the site of vaccination. In a person with
      immunity to smallpox the skin reaction is much less, and typically consists of a little
      swelling at the site of vaccination.
    


Intervention name(s): ACAM3000 MVA Vaccine
Intervention type(s): Biological
Intervention description(s): Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
Other intervention name(s): Dryvax smallpox vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Smallpox; Smallpox Vaccine; Variola virus; Smallpox Virus; MODIFIED VACCINIA ANKARA; MVA; Dryvax; Dryvax vaccine; Protection against smallpox
A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin in Healthy Chinese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (what the body does to the
      medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754
      (canagliflozin) and its main metabolites (break-down products) following 2 different doses of
      canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin will
      also be assessed.
    

Detailed description: 
      This study will be a double-blind (neither the Investigator nor volunteer knows the assigned
      treatment), randomized (the treatment is assigned by chance), placebo-controlled (one of the
      study treatments is inactive), single-dose, 3-way cross over study (all volunteers will
      receive each of the 3 treatments but in a different order) in healthy Chinese volunteers.
      Volunteers will be assigned to 1 of 3 treatment sequence groups (ABC, BCA, or CAB). The
      treatment sequence will be decided by randomization. Treatment A will be a single oral (by
      mouth) dose of 100 mg of canagliflozin. Treatment B will be a single oral dose of 300 mg of
      canagliflozin. Treatment C will be a single oral dose of placebo (inactive medication). Each
      treatment will be given during a treatment period of 5 days duration; each treatment period
      will be separated by a washout period (a time period with no medication) of at least 10 days.
      Canagliflozin is currently being investigated for the treatment of type 2 diabetes mellitus
      (T2DM).
    

Intervention name(s): Treatment A: Canagliflozin 100 mg; Treatment B: Canagliflozin 300 mg; Treatment C: Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.; Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.; Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.
Other intervention name(s): JNJ-28431754; JNJ-28431754
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; JNJ-28431754; Canagliflozin; Pharmacokinetics; Pharmacodynamics
Respiratory Muscle Endurance Training in Healthy Elderly
Condition: Healthy
Study type: Interventional

Summary: 
      Prevalence of hypertension in the elderly is high. Given that hypertension is the leading
      cause of cardiovascular disease worldwide, safe and efficacious treatment options for this
      condition are highly desired. Apart from medication, changes in lifestyle are recommended to
      lower blood pressure, such as an increase in physical exercise. However, whole-body exercise
      is not feasible for all. Mobility disabilities, for example, increase sharply with age and
      are already common in middle age. For this population, it is necessary to have alternative,
      non-invasive interventions with similar effects on blood pressure. One such intervention
      might be respiratory muscle endurance training (RMET), but the effects on blood pressure are
      currently unknown.

      The primary aim of this project is therefore to investigate the effects of RMET over the
      course of several weeks on resting blood pressure in healthy elderly. The secondary aim of
      the project is to evaluate the effects of RMET on uphill exercise performance in healthy
      active elderly given that elderly experience structural and functional changes of the lungs
      potentially affecting exercise performance. Finally, since prevalence of subjective sleep
      complaints is also high in the elderly, the present study will also investigate the effects
      of RMET on sleep quality.
    


Intervention name(s): Respiratory muscle endurance training
Intervention type(s): Device
Intervention description(s): Respiratory muscle endurance training performed over the duration of 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Gene Expression Profiles in Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The purpose of this study is to test differences in RNA levels between Multiple Sclerosis
      (MS) patients and normal subjects. RNA provides a "message" from genes altered in diseases.
      We will also test DNA to determine if there are any small mutations called SNPs in any of the
      genes. The last tests are two separate tests for markers of inflammation called cytokines and
      eicosanoids. This research may lead to the discovery of biological markers for MS that are
      useful for diagnosis and treatment.
    

Detailed description: 
      This is an investigator-initiated, pilot study of gene expression (RNA) in the blood of
      patients with multiple sclerosis (MS). The study will enroll patients from the UC Davis
      Multiple Sclerosis clinic. At a single study visit, we will confirm eligibility, obtain
      clinical information, and collect blood samples. We will then process these samples to obtain
      RNA for subsequent microarray analysis. DNA will also be used to examine single nucleotide
      polymorphisms (SNPs) on chips that allow us to examine 1 million of these SNPs. The SNPs may
      allow us to diagnose a disease like multiple sclerosis or to predict a treatment or cause. In
      addition, the DNA may be used to determine if there are any small mutations in any of the
      genes in the individuals who donate their blood. Additional studies will be done on blood
      plasma, testing for inflammatory molecules called eicosanoids and cytokines. The data from
      these tests will be superimposed on the microarray data to determine a molecular profile for
      each patient. We will then compare the data obtained between patient groups to determine gene
      alterations specific for each condition.
    

Intervention name(s): Blood Draw
Intervention type(s): Other
Intervention description(s): 35 cc of peripheral blood will be obtained by venipuncture from each subject.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult subjects aged 18 to 70 will be enrolled. There will be four study groups: patients
        with a clinically isolated syndrome (CIS), patients with untreated relapsing-remitting MS
        (RR-MS), patients with chronic, progressive MS (CPMS), and age- and gender-matched control
        subjects without MS. Patients of both sexes and all races will be recruited into the study
        without bias.
      
Biospecimen description: 
      35cc of peripheral blood will be obtained from each subject via venipuncture.
    
Keywords: Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Chronic Progressive Multiple Sclerosis; Clinically Isolated Syndrome; Normal Controls; Blood Draw
Role of Nitrogen Oxide (NO) in the Control of Choroidal Blood Flow During a Decrease in Ocular Perfusion Pressure
Condition: Physiology, Ocular; Microcirculation; Regional Blood Flow; Autoregulation
Study type: Interventional
Phase: Phase 2

Summary: 
      Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in
      perfusion pressure. For a long time it had been assumed that the choroid is a strictly
      passive vascular bed, which shows no autoregulation. However, recently several groups have
      identified some autoregulatory capacity of the human choroid. In the brain and the retina the
      mechanism behind autoregulation is most likely linked to changes in transmural pressure. In
      this model arterioles change their vascular tone depending on the pressure inside the vessel
      and outside the vessel. In the choroid, several observations argue against a direct
      involvement of arterioles. However, the mechanism behind choroidal autoregulation remains
      unclear.

      In the present study autoregulation of the choroid will be investigated during a decrease in
      ocular perfusion pressure, which will be achieved by an increase in intraocular pressure.
      Pressure/flow relationships will be investigated in the absence or presence of a NO synthase
      inhibitor. As a control substance the alpha-receptor agonist phenylephrine will be used.
    


Intervention name(s): Suction cup application; Laser Doppler flowmetry; Measurement of intraocular pressure
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): he IOP will be raised by a 11 mm diameter, standardized suction cup placed on the temporal sclera with the anterior edge at least 1 mm from the limbus.; Measurement of choroidal blood flow
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in
      healthy subjects
    


Intervention name(s): gemigliptin only; rosuvastatin only; gemigliptin and rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): gemigliptin 50mg qd on day 1~7; rosuvastatin 20mg qd on day 1~7; gemigliptin 50mg, rosuvastatin 20mg qd on day 1~7
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Netazepide on Omeprazole-induced Changes in Chromogranin A and Gastrin
Condition: ECL-cell Hyperplasia; Parietal-cell Hyperplasia; Rebound Hyperacidity; Dyspepsia
MeSH terms: Hyperplasia; Dyspepsia
Study type: Interventional
Phase: Phase 1

Summary: 
      Hypergastrinaemia induced by proton pump inhibitor (PPI) treatment is reported to cause
      ECL-cell and parietal-cell hyperplasia, and rebound hyperacidity and dyspepsia after PPI
      withdrawal.

      The objective of the study was to determine the dosage regimen of netazepide, a gastrin/CCK2
      receptor antagonist, required to inhibit the trophic effects of PPI-induced
      hypergastrinaemia.

      Six groups of 8 healthy subjects participated in a randomised, double-blind,
      placebo-controlled exploratory study of esomeprazole 40 mg daily for 28 days, and netazepide
      1, 5 or 25 mg, or placebo daily during the last 14 days of esomeprazole dosing, or 14 days
      after esomeprazole withdrawal. Serum gastrin and plasma chromogranin A (CgA) were measured
      regularly from study start until at least 1 week after the last dose. Dyspepsia was monitored
      after esomeprazole withdrawal.
    

Detailed description: 
      Non-clinical studies have shown that PPI-induced hypergastrinaemia leads to rebound gastric
      hyperacidity after PPI withdrawal. A gastrin/CCK2 receptor antagonist inhibits that response.
      Studies in healthy subjects and patients also suggest that PPI withdrawal leads to rebound
      hyperacidity, but the evidence is controversial. However, there is better evidence from
      studies in healthy subjects that PPI withdrawal can lead to dyspepsia.

      The principal aims of this study were: to assess the effect of different dose regimens of
      netazepide on the increases in circulating gastrin and CgA induced by esomeprazole in healthy
      subjects; and to choose a dose regimen for future studies of esomeprazole withdrawal in
      patients. The secondary aims were: to assess if omeprazole withdrawal leads to dyspepsia, and
      if so whether it can be prevented by netazepide; and to assess the likelihood of an
      interaction between esomeprazole and netazepide. Gastrin and CgA are biomarkers of acid
      suppression and increased ECL-cell activity, respectively.

      This was a randomised, double-blind, placebo-controlled, parallel-group, pilot study, in
      which six groups of eight healthy subjects took esomeprazole 40 mg daily for 28 days, and
      netazepide 1, 5 or 25 mg, or placebo, daily during the last 14 days of esomeprazole dosing,
      or the 14 days immediately following esomeprazole withdrawal (25 mg only). Gastrin and CgA
      were measured before the start of dosing until at least one week after completion of dosing.
    

Intervention name(s): netazepide
Intervention type(s): Drug
Other intervention name(s): YF476
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Marijuana Approach Bias Retraining and Neural Response in Youth
Condition: Alcohol Approach/Avoidance Task; Sham Approach/Avoidance Task
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      This study aims to determine if a marijuana (MJ) Approach Avoidance Task (AAT) intervention
      reduces cannabis use compared to a control condition containing no active components of AAT.
      Adolescent heavy MJ users (N=40, ages 16-21) will be randomly assigned to MJ-AAT (n=20) or
      control condition (MJ-Sham, n=20) for three weeks. The MJ-AAT includes six sessions designed
      to reduce action tendencies to approach marijuana. The MJ-Sham includes six MJ-AAT-sham
      conditions. Substance use and cognitive assessment will identify changes in MJ use patterns
      and mechanisms of treatment outcomes. Additionally, using an functional magnetic resonance
      imaging marijuana cue reactivity task, we will determine differences in neural response in
      reward regions before and after 3 weeks of either AAT or sham treatment.
    


Intervention name(s): Marijuana Approach Avoidance Training
Intervention type(s): Behavioral
Intervention description(s): Approach Avoidance Training (AAT) is a novel computerized procedure that modifies implicit approach tendencies by training individuals to selectively avoid drug- related stimuli, thereby overriding habitual approach tendencies. Participants are randomized to either the treatment or sham condition. Treatment duration involves 6 training sessions of approximately 15 minutes each (400 trials). AAT requires minimal training and involves only a computer and a joystick, in which participants are either pulling or pushing the joystick when different marijuana or non-marijuana images are displayed with either yellow (pull) or blue (push) border.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Efficacy and Safety Study of Elagolix in Women With Endometriosis
Condition: Endometriosis, Pain
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate elagolix (NBI-56418) compared to placebo for its
      effects on endometriosis related pelvic pain and its safety.
    

Detailed description: 
      Participants were randomized (1:1) to 150 mg elagolix once daily or placebo once daily for
      the first 8 weeks of the study. Following 8 weeks of dosing, participants continued in the
      study for an additional 16 weeks in an open-label phase where all participants still enrolled
      in the study received 150 mg elagolix once daily.

      There was no pre-specified primary efficacy end point for this study as there is no single
      key efficacy outcome measure in this exploratory Phase 2 study. However, the efficacy
      measures of primary interest included the daily assessment of dysmenorrhea, non-menstrual
      pelvic pain and dyspareunia on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe)
      using an e-Diary.
    

Intervention name(s): Placebo; Elagolix
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo tablets taken orally once a day; Immediate release (IR) tablets taken orally once a day
Other intervention name(s): NBI-56418; Orilissa™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pelvic Pain,NBI-56418,Endometriosis