bioihbjkbjnl/mcl2 huggingface dataset:
Natural Procreative Technology Evaluation and Surveillance of Treatment for Infertility and Miscarriage
Condition: Infertility and Miscarriage
MeSH terms: Infertility; Abortion, Spontaneous
Study type: Observational

Summary: 
      This study involves research, and the purpose of this study is to evaluate live birth rates
      among couples who are treated by Natural procreative technology, (NPT) for infertility and
      miscarriage.

      Comparisons will be made to those declining NPT treatment, waiting for NPT treatment,
      receiving other treatment, or stopping treatment. The investigator seeks to document specific
      pregnancy rates for different factors such as age and type of infertility diagnosis.
      Investigators will also assess characteristics of environmental exposures that may be
      associated with infertility. Couples will be followed for up to three years, regardless of
      when they begin NPT treatment, or whether they continue treatment. Data from all couples will
      be useful for this study, regardless of their individual circumstances or actual treatment.
    

Detailed description: 
      This is a prospective cohort observational study. Couples presenting for possible treatment
      with NPT will be recruited for participation in the study. No randomization will occur. If a
      couple agrees to participate, investigators will collect information in three ways:

        1. Questionnaires. (standard of care) These will be done at entry (SOC) to the study, on an
           annual basis for up to three years (research related), for any pregnancy, or whenever a
           patient exits the study. Questionnaires may be done by mail, email, or telephone. Each
           questionnaire has a woman's and a man's version, except the pregnancy questionnaire,
           which only has a woman's version. Each questionnaire will take approximately 30-45
           minutes to complete.

        2. The subject's own Creighton Model fertility charts. (standard of care)

        3. Information about NPT treatment and pregnancies from the medical records of their NPT
           physician(s). (standard of care)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Couples seeking NPT treatment or consultation to achieve pregnancy, to maintain pregnancy,
        or for fertility-related health issues will recruited from our practice. Providers will
        present the study information to the patients at their initial visit. No recruitment by
        phone or mail will be done.
Therapies for Treatment-Resistant Panic Disorder Symptoms
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will determine the effectiveness of different treatments for panic disorder
      symptoms in individuals who still have symptoms after initial treatment with medication.
    

Detailed description: 
      Panic disorder is a serious condition that may cause significant psychological and physical
      distress. Many patients with panic disorder remain symptomatic despite initial intervention.
      Unfortunately, little data is available to guide health care providers in "next-step"
      treatment approaches. This study will evaluate the effectiveness of treatments for
      individuals with panic disorder that is resistant to initial treatment with selective
      serotonin reuptake inhibitors (SSRIs).

      This study will last 24 weeks and will comprise three phases. In Phase 1, participants will
      receive the SSRI sertraline for 6 weeks. Phase 1 will be used to determine participants'
      resistance to treatment. During Phase 1, participants will begin a medication schedule and
      symptom diary and will have weekly study visits to assess regimen adherence and any side
      effects they may be experiencing. In Phase 2, participants will be randomly assigned to 6
      weeks of one of two treatments: sertraline at an elevated dose from that given in Phase 1 or
      a sertraline and placebo regimen. During Phase 2, participants will have 3 study visits.
      Self-report scales and diary entries will be used to assess panic disorder symptoms and
      medication side effects. In Phase 3, participants will be randomly assigned to receive either
      cognitive behavioral therapy (CBT) or sertraline and clonazepam for 12 weeks. All
      participants will have weekly study visits during Phase 3. Questionnaires and self-report
      scales will be used to assess participants at the end of Phase 3.

      Study hypothesis: Combined selective serotonin reuptake inhibitors (SSRIs) and benzodiazepine
      treatment, increasing the dose of SSRI, and the addition of cognitive behavioral therapy
      (CBT) each may have benefits for patients with panic disorder who remain symptomatic after
      initial treatment with SSRIs.
    

Intervention name(s): Clonazepam; Sertraline; Cognitive behavioral therapy
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Participants will receive clonazepam.; Participants will receive sertraline.; Participants will receive cognitive behavioral therapy
Intervention MeSH terms: Clonazepam; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Selective serotonin reuptake inhibitor; Anxiety; Pharmacotherapy; Cognitive behavioral therapy; CBT
Efficacy of Stretching on Pain Sensitivity
Condition: Pain Threshold
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The primary objective of this study is to determine the immediate efficiency of a six weeks
      regular stretching protocol on regional and distant pain sensitivity. It is hypothesised that
      regional and distant pain sensitivity will significantly decrease following six weeks of
      regular stretching.

      The secondary objective of the study is to determine the effect after four-week cessation of
      the stretching protocol on regional and distant pain sensitivity. If regional and distant
      pain sensitivity decrease following regular stretching, it is hypothesised that the analgesic
      effect will abate following four-week cessation.
    


Intervention name(s): Stretch exercises
Intervention type(s): Other
Intervention description(s): The intervention comprises of six weeks daily bi-lateral static stretching of the knee flexors. Stretches are performed seated on the ground. The participant sits upright on the floor with one leg straight. The sole of the other foot should be placed on the inside of the outstretched leg. The participant leans slightly forward, trying to touch their toes while maintaining full knee extension. Stretching is performed to the point of discomfort, and each stretch is held for 30-seconds for three repetitions.
Intervention model: Single Group Assignment
Intervention model description: Single-blind longitudinal repeated measures study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Stretching; Pain sensitivity; Range of motion; Exercise adherence
Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome
Condition: Hyperinsulinism; Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Hyperinsulinism; Syndrome
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Determine whether reduction of serum insulin levels by metformin increases ovulatory
      response to clomiphene or spontaneous ovulation in obese women with polycystic ovary
      syndrome.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
      Patients are randomized to one of two treatment arms.

      Patients receive oral metformin (arm I) or oral placebo (arm II) three times daily for 8
      weeks. All patients who do not ovulate by day 28 receive oral clomiphene citrate daily on
      days 36-40.
    

Intervention name(s): clomiphene citrate; metformin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: endocrine disorders; hyperinsulinism; polycystic ovarian syndrome; rare disease
The Impact of Arousal Threshold in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low
      arousal threshold may wake up too early during a respiratory event, before upper airway
      muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the
      respiratory arousal threshold could potentially improve the quality of sleep and sleep
      disordered breathing. Agents that raise arousal threshold are therefore likely to benefit
      some patients with OSA. The overall goal of this project is to determine the importance of
      the arousal threshold in OSA, determine which patients might benefit from a raised arousal
      threshold, and test this hypothesis by using pharmacological manipulation of the arousal
      threshold to achieve this goal.
    

Detailed description: 
      This study is a pilot study. The investigators will test whether donepezil has important
      effects on the arousal threshold and on the apnea hypopnea index.

      Donepezil is a cholinesterase inhibitor approved by the U.S. Food and Drug Administration
      (FDA) for the treatment of symptoms of Alzheimer's disease.

      Eligible participants will undergo overnight polysomonography as described below and will
      receive either donepezil (10 mg immediately prior to sleep) or placebo (in random order)
      followed roughly 14 days later with placebo or donepezil. This aim will allow us to test the
      impact of donepezil on the apnea hypopnea index. The study plans to enroll approximately 30
      subjects.

      The change in apnea hypopnea index as well as arousal thresholds/upper airway mechanics will
      be compared in the donepezil groups with the placebo group.
    

Intervention name(s): Donepezil; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Donepezil 10mg before sleep; One piece of placebo before sleep
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive; Sleep Apnea; Arousal threshold; Donepezil
the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      To compare the effect of myopia control between patients treated with low-concentration
      atropine eye drops combined with auricular acupoint stimulation and those treated with
      atropine alone.
    

Detailed description: 
      Myopia has been an increasing problem among school children, especially in Asian countries.
      High myopia is not only a refractive problem, but also a disease that can result in a number
      of sight-threatening complications such as macular degeneration, retinal detachment,
      glaucoma, and cataract. Atropine is a long-acting non-selective muscarinic antagonist that
      blocks accommodation by paralyzing ciliary muscles; it may affect remodeling of the sclera
      and suppress the elongation of axial length. Acupuncture and acupressure have been widely
      used in traditional Chinese medicine for thousands of years. Auricular acupoint stimulation
      by acupuncture or acupressure has been reported to improve visual acuity in myopic patients.
      Therefore, we want to compare the effect of myopia control between patients treated with
      low-concentration atropine eye drops combined with auricular acupoint stimulation and those
      who treated with atropine alone.
    

Intervention name(s): Atropine; auricular acupoint stimulation
Intervention type(s): Drug; Device
Intervention description(s): topical 0.125% atropine eye drops; Five auricular acupoints (Shenmen, Xin, Yan, Mu 1 and Mu 2) Tapping stimulation was administered by using a 1-mm alloy ball (Magrain®; Sakamura, Kyoto, Japan) three times a day, each time for five minutes.
Other intervention name(s): 0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan); a 1-mm alloy ball (Magrain®; Sakamura, Kyoto, Japan)
Intervention MeSH terms: Atropine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: myopia; atropine; anterior chamber depth; auricular acupoint; axial length
ROTAHALER Device Optimization Study
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the pharmacokinetic (PK) of Fluticasone Propionate/Salmeterol
      combination (FSC) 100/50 micrograms (mcg) delivered via the capsule-based inhaler (Rdpi)
      relative to FSC 100/50 mcg delivered via the multi-dose dry powder inhaler (Ddpi) to
      establish whether the Rdpi inhaler has exposure (in terms of fluticasone propionate area
      under time concentration curve [AUC] and Salmeterol maximum concentration [Cmax]) no greater
      than 1.2500 compared to the Ddpi, sufficient to allow progression to Phase 3. This study will
      enroll 36 healthy adult male and female subjects and each subject will be allocated to one of
      two sequences and will participate in four treatment periods, receiving each of the
      treatments twice.
    


Intervention name(s): Fluticasone Propionate / Salmeterol Xinafoate DISKUS; Fluticasone Propionate / Salmeterol Xinafoate ROTACAP
Intervention type(s): Drug; Drug
Intervention description(s): Fluticasone propionate and salmeterol xinafoate combination as a dry powder inhaler for oral inhalation with unit dose strength of 100/50 mcg (available in blister pack) administered via DISKUS (Ddpi) device.; Fluticasone propionate and salmeterol xinafoate combination as a dry powder inhaler for oral inhalation with unit dose strength of 100/50 mcg (available in blister pack) administered via ROTAHALER (Rdpi) device.
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; fluticasone propionate/salmeterol; PK equivalence; COPD; pharmacokinetics; fluticasone propionate/salmeterol in a capsule-based inhaler; fluticasone propionate/salmeterol in a multi-dose dry powder inhaler; Respiratory
Dietary Nucleotides and Ribose on Muscle Fuel Utilisation
Condition: Healthy
Study type: Interventional

Summary: 
      Nucleotides are the building blocks for a variety of molecules, including ATP, which is
      broken down in the skeletal muscle cells to provide fuel for exercise. Nucleotides can be
      obtained from the diet, and produced or salvaged by the body. Though nucleotides provide the
      building blocks for ATP, the sugar ribose has been suggested to be rate limiting for
      synthesising ATP.

      Previous studies have shown a decrease in ATP levels in the muscle after intense exercise,
      and this is linked to fatigue. Other studies have also reported benefits of nucleotide and/or
      ribose supplementation on exercise performance. However, any potential link between ATP
      metabolism and exercise performance has not been explored.

      This study will look at the effects of nucleotide and nucleotide-ribose supplementation in
      fuel utilisation and performance in skeletal muscle during endurance exercise.
    


Intervention name(s): Low nucleotide; High nucleotide; High nucletide + Ribose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2 week, twice daily, supplementation with a nucleotide-depleted mycoprotein drink, with added dextrose; 2 week, twice daily, supplementation with a nucleotide-rich mycoprotein drink, with added dextrose; 2 week, twice daily, supplementation with a nucleotide-rich mycoprotein drink, with added ribose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effect of Nitrous Oxide (N2O) on Intraocular Pressure in Healthy Volunteers
Condition: Glaucoma; Sedation
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to learn if breathing nitrous oxide (also known as "laughing
      gas") changes the pressure in a person's eyes. Some patients who need regular eye exams to
      measure their eye pressure often need to be put to sleep with medicine in order to complete
      the eye exam. Some of these medicines are known to cause changes in a person's eye pressure.
      Because of this, such medicines are avoided if the eye doctor needs to measure the patient's
      eye pressure. One medicine that is frequently used to put patients to sleep is nitrous oxide.
      No one really knows what effect nitrous oxide might have on a persons' eye pressure. The
      investigators are interested to see if nitrous oxide causes an increase, decrease, or no
      change in eye pressure. The investigators also want to investigate if there is a difference
      in the effects of nitrous oxide on eye pressure between males and females. Understanding
      these effects of nitrous oxide is important because during such eye exams, the eye doctor
      uses the pressure measurements to make important decisions about treatment and surgery
      options for the patient.

      The investigators hypothesize that the use of inhaled nitrous oxide (N2O) will result in a
      decrease in IOP in healthy volunteers.

      The investigators aim to determine the magnitude and duration of change, if any, in IOP
      caused by inhalation of N2O, and to assess if the gender of the patient has a role in this
      effect.
    

Detailed description: 
      An initial pre-anesthetic evaluation and physical examination will be performed by an
      attending anesthesiologist, and an eye exam will be performed by an attending ophthalmologist
      to determine suitability for inclusion according to the above criteria. Ideally the eye exam
      will take place immediately prior to conduction of the study. However, logistical restraints
      may require that the eye exam take place at a separate time/date prior to conduction of the
      study. IOPs will be measured by the attending ophthalmologist (B.E.) who will be blinded to
      the actual readings of the Tonopen by means of a small screen, and a single trained observer
      (E.F.) will record observations from the Tonopen. The nitrous oxide sedation will be managed
      by the attending anesthesiologist (K.L.). All patients will be monitored throughout using
      standardized monitoring (continuous EKG, non-invasive BP, and continuous pulse oximetry).
    

Intervention name(s): Nitrous oxide
Intervention type(s): Drug
Intervention description(s): Nitrous oxide sedation by inhalation
Other intervention name(s): N2O
Intervention MeSH terms: Nitrous Oxide
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Glaucoma; Nitrous oxide
Stress & Anxiety Dampening Effects of a Probiotic Supplement Compared to Placebo in Healthy Subjects
Condition: Healthy; Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The aim of this study is to assess whether a 5 week intake of a probiotic (Lpc-37) can
      modulate stress and anxiety experienced by healthy subjects during and after an acute
      stressor compared to placebo. To measure stress and anxiety, markers of the
      hypothalamic-pituitary-adrenal (HPA) axis activity and questionnaires will be assessed
      before, during and after the Trier Social Stress Test (TSST). The results of this study
      indicate if the chosen study design is suitable to discover stress-related effects of
      probiotics.
    

Detailed description: 
      The total mass of microorganisms residing within the human intestine is approximately the
      same as that of the human brain. Of late, these >1000 species and >7000 strains have been
      described as the "brain in our belly" because of the essential role they play in
      physiological and psychological health and disease. The gut-brain axis describes the
      bidirectional communication that exists between the brain and the gut and the
      microbiota-gut-brain axis supports the role of the gut microbiome in this communication
      system. Emotional and routine daily life stress can disrupt digestive function, but
      increasing evidence indicates that the gut microbiota exert a profound influence on brain
      physiology, psychological responses and ultimately behavior.

      A plethora of literature to date, albeit predominantly preclinical, have demonstrated
      evidence to support the role of the gut microbiome in regulating stress-related changes in
      physiology, behavior and brain function.

      Stress is an individual process to deal with external and internal challenges that ranges
      from behavioral to molecular adaptations. The HPA axis and its release of stress hormones
      plays a major role in stress adaptation.

      The purpose of this clinical trial is to determine whether a single strain of bacteria
      derived from the species Lacticaseibacillus paracasei Lpc-37 (Lpc-37), formerly Lactobacillus
      paracasei Lpc-37, can modulate stress experienced by healthy subjects exposed to the TSST
      measured by HPA axis activation markers and self-report questionnaires.
    

Intervention name(s): Lpc-37; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lacticaseibacillus paracasei Lpc-37 at 1.75 x 10^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide; microcrystalline cellulose, magnesium stearate, silicon dioxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Probiotic; Gut-brain axis; Stress; Anxiety
This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)
Condition: Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to assess the efficacy and safety of BT595 in adult
      subjects with chronic ITP. The primary objective of this study is to determine the rate of
      subjects with a response. A response is defined as a platelet count of ≥30×10^9/L and at
      least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at
      least 7 days apart, and the absence of bleeding. The secondary objectives of this study, in
      addition to further efficacy assessments, are to evaluate the safety of BT595.
    


Intervention name(s): BT595
Intervention type(s): Biological
Other intervention name(s): Human Immunoglobulin
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment