bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)
Condition: Postmenopause
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate three new investigational tablet formulations of the Food and Drug Administration
      (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).
    


Intervention name(s): Premarin/MPA 0.45 mg/1.5 mg
Intervention type(s): Drug
Intervention MeSH terms: Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of AD113 and Atomoxetine in OSA Patients With Hypertension
Condition: Obstructive Sleep Apnea; Hypertension
MeSH terms: Sleep Apnea, Obstructive; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double blind, 2-period, non placebo-controlled crossover study in
      patients with moderate to severe OSA and controlled hypertension, comparing atomoxetine with
      AD113
    

Detailed description: 
      The study is designed to examine the efficacy and safety of AD113 to treat obstructive sleep
      apnea with hypertension. The study is a two-period multi-dose randomized crossover design in
      which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of
      the following 2 treatments: AD113 for 10 days or Atomoxetine for 10 days. Participants will
      return 1 week after their final crossover PSG for an end of study (EOS) Visit.
    

Intervention name(s): AD113; Atomoxetine
Intervention type(s): Drug; Drug
Intervention description(s): Two oral capsules administered before bed; Two oral capsules administered before bed
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Refractory Urinary Retention Secondary to Benign Prostatic Hyperplasia (BPH) With Dual Five Alpha Reductase Inhibition Combined With an Alpha Blocker
Condition: Urinary Retention; Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Urinary Retention; Hyperplasia
Study type: Interventional

Summary: 
      To determine whether the addition of a dual Five Alpha Reductase Inhitor (Dutasteride) will
      alleviate urinary retention secondary to BPH in who have failed a voiding trial without a
      catheter. Following treatment with an Alpha Blocker alone.
    


Intervention name(s): Dutasteride
Intervention type(s): Drug
Intervention description(s): Patients will continue on their alpha blocker in addition to Dutasteride 0.5mg daily for a maximum of 3 months
Intervention MeSH terms: Dutasteride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary retention secondary to benign prostatic hyperplasia
Cathelicidin LL-37 Relation to Potentially Malignant Lesions
Condition: Oral Potentially Malignant Lesions
Study type: Observational

Summary: 
      LL-37 appears to have a potential role in potentially malignant lesions (OLP & leukoplakia).
      The remarkable diagnostic accuracy of salivary LL-37 in differentiating potentially malignant
      lesion and healthy control could confirm its utilization as an innovative marker to early
      diagnose potentially malignant lesions. Salivary LL-37 being non-invasive accurate marker
      could be as a chair-side diagnostic method that detect potentially malignant lesions.
    

Detailed description: 
      Aim: The recognition of practical early diagnostic biomarkers is a cornerstone of improved
      prevention and treatment of cancer thus the current study estimated salivary level of
      Cathelicidin LL-37 in patients suffering from potentially malignant lesions and control
      subjects to corroborate Cathelicidin LL-37 as a diagnostic marker for early detection of
      potentially malignant diseases and revealing its possible role in carcinogenesis.

      Methodology: 45 systemically healthy individuals were subdivided into three groups: Group I:
      15 Healthy participants without any oral lesions. Group II: 15 Patients having
      atrophic/erosive oral lichen planus (OLP). Group III: 15 Patients having oral leukoplakia..
      Enzyme linked immune-sorbent assay (ELIZA) kit was used to evaluate the level of LL-37 in
      whole unstimulated salivary samples collected from all participants. To reveal AUC,
      sensitivity, specificity, and diagnostic accuracy of LL-37 receiver operating curve (ROC)
      analysis was done.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A total number of 45 systemically healthy participants were included in this study that
        were divided equally into 3 groups: Group I: 15 Healthy participants without any oral
        lesions. Group II: 15 Patients having atrophic/ erosive oral lichen planus. Group III: 15
        Patients having oral leukoplakia.
      
Keywords: Oral potentially malignant lesions, Cathelicidin LL-37
Beverage Consumption and Fine Motor Control
Condition: Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The aim of this study will be to compare the effects of daily consumption of aspartame,
      rebaudioside a, saccharin, sucralose, and sucrose on body weight and composition in a
      standardized protocol. The investigators hypothesize that individual low calorie sweeteners
      (consumed in a beverage) differ from each other in promoting weight loss and decreased fat
      mass (without energy restriction or dietary guidance) based on their chemical structure.
    


Intervention name(s): Beverage
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will receive 1.25 - 1.75 L of sweetened beverage a day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: energy intake; energy expenditure; appetite
Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery
Condition: Bariatric Surgery; Obesity; Weight Gain
MeSH terms: Obesity; Weight Gain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate safety and efficacy of twice-daily ARD-101 in
      subjects at least one year after bariatric surgery (sleeve gastrectomy or gastric bypass).
    

Detailed description: 
      This is a Phase 2, open-label study to investigate the safety and efficacy of twice-daily
      ARD-101 in subjects at least one year after bariatric surgery (sleeve gastrectomy or gastric
      bypass). This study has a planned enrollment of 30 subjects (approximately 15 for each
      preceding surgical procedure) and will be conducted in a single center in the United States.

      The study will consist of a Screening Period (up to 28 days), a Treatment Period (28 days),
      and a Follow-up Period (EOS Visit within 14 days after receiving the last dose of ARD-101).
      The screening procedures will be initiated upon completion of the informed consent process.
      Following completion of screening procedures and confirmation of eligibility, subjects will
      be enrolled to receive ARD-101.
    

Intervention name(s): ARD-101
Intervention type(s): Drug
Intervention description(s): Twice daily, oral administration
Intervention model: Single Group Assignment
Intervention model description: This study includes one intervention arm.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Bariatric Surgery; Weight Gain; Anti-Obesity Agents
Efficacy and Safety of Foscarnet Sodium and Sodium Chloride Injection in Patients With Herpes Zoster
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Foscarnet Sodium and
      Sodium Chloride Injection in patients with herpes zoster, and observe incidence of
      Postherpetic neuralgia
    


Intervention name(s): Foscarnet Sodium; Acyclovir
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acyclovir; Foscarnet; Phosphonoacetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: herpes zoster, Foscarnet Sodium, Acyclovir, Postherpetic neuralgia
Anaerobic Exercises on Cardiac Workload, Peripheral Resistance and Lipid Index Among Grade 1 Hypertensive Young Adults
Condition: Blood Pressure
Study type: Interventional

Summary: 
      Impact of resistance exercises on grade I hypertensive patients were monitored on three
      outcome measures that were blood pressure, peripheral resistance and lipid index after 12
      weeks of intervention
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Resistance training using dumbbells and therabands
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Scintigraphic Assessment Following Klean-Prep® or Moviprep®
Condition: Gastric Emptying; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a phase 1, open-label, randomized study, designed to assess the impact of Moviprep®
      or Klean-Prep® on gastrointestinal transit. It was performed in two parallel groups with Part
      A in two groups of four subjects preceding Part B, which was performed in two groups of 12
      subjects. Subjects attended a pre-study medical within 28 days of dosing and a post-study
      medical 5-10 days after the final dose. Within both Part A and Part B, subjects were required
      to attend the clinical unit for 2 study periods. Part A consisted of a baseline period to
      determine individual reference times for gastrointestinal transit. Part B was the test period
      in which gastrointestinal transit following the administration of the test preparations was
      assessed.
    


Intervention name(s): Klean-Prep®; Moviprep®
Intervention type(s): Drug; Drug
Intervention description(s): Four litres of solution administered orally as a divided dose.; Two litres of solution administered orally as a divided dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Features, Outcomes, and Therapeutics of Pregnancy-Related Aortic Dissection
Condition: Aortic Dissection; Pregnancy Related
MeSH terms: Aortic Dissection
Study type: Observational

Summary: 
      Aortic dissection in pregnancy represents a lethal risk to both the mother and fetus, it has
      yet to yield the optimal therapeutic strategy. The aim of this study was to characterize the
      clinical features and outcomes in women with pregnancy-related acute aortic dissection, and
      to suggest therapeutic guidelines.
    


Intervention name(s): cesarean section and aortic repair
Intervention type(s): Procedure
Intervention description(s): The timing of aortic repair and delivery have to be determined based on the type of the dissection, the stage of pregnancy (the gestation age), and the status of the fetus, as well as the level of local neonatal service.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From February 1 2012 through June 30 2022 for identification women who presented with
        aortic dissection during pregnancy or post partum ≤12 weeks
Pilates Exercises v/s Yoga on Rounded Shoulders
Condition: Weakness, Muscle; Muscle Tightness; Range of Motion; Pain; Heart Rate; SpO2; Sleep Quality
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      To Compare the effects of Pilates exercises an yoga on rounded shoulders
    

Detailed description: 
      Pilates exercises and Yoga are two effective treatments for correcting RSP. In Pilates each
      exercise is conducted in more than one times usually three to five hence exposing the body to
      different and new muscular and kinesthetic challenges. On the other hand Yoga is a process in
      which the joints and muscles operate together in a systematic and automatic manner where each
      pose is sustained for a period of time. Several literatures support the belief that Pilates
      exercises and Yoga are effective treatments for RSP correction, as well as improving sleep
      quality, heart rate and SpO2 First, The participants will be divided into two groups, for
      Pilates exercises and Yoga. Honor wristbands will be distributed and Exercises will be
      demonstrated to each group. Explanation of using Honor band will be given. Measurements will
      be taken before the intervention including cervical ROM. shoulder ROM at baseline, 2nd week
      and 4th week. while heart rate, SpO2 immediately after the session. Sleep quality prior the
      intervention, 2nd and 4th week. Patients will do the exercises 3 times per week for 4
      consecutive weeks.
    

Intervention name(s): Pilates exercises; Yoga
Intervention type(s): Other; Other
Intervention description(s): Pilates exercises starts with warm up, followed by 6 main exercises that are Swan, Swimming, Prone press up, Dart, Arm arch and Scarecow. The session will end with the cool down exercises. Each exercise will be repeated 10 times for 5 sets. Patients will be treated 3 times per week for 4 consecutive weeks.; Yoga will start with warm up followed by 6 yoga poses which are Warrior pose 1, Triangle pose, Child pose, Cow face pose, Bound angle pose, half bow poseThe session will end with a cool down pose. Each yoga pose will be held for 8-10 breathes Patients will be treated 3 times per week for 4 consecutive weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Relative Bioavailability Study of CC-292
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the PK profile of the newly developed CC-292 SDD formulation compared to CC-292
      P22 tablet.
    

Detailed description: 
      This is a single center, open-label, randomized, seven-treatment, seven-period, crossover
      design. The study will consist of a screening phase, a treatment phase, and a follow-up phone
      call. Approximately 24 healthy adult subjects (male or female) will be enrolled.
    

Intervention name(s): CC-292; Oral Omeprazole (OMP)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; CC-292; Open-Label; Bioavailability Pharmacokinetics; Phase I
Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism
Condition: Quality of Life; Depression
MeSH terms: Hypothyroidism; Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with
      autoimmune hypothyroidism, on stable T4-substitution therapy
    

Detailed description: 
      double blind randomized cross-over study.
    

Intervention name(s): Triiodothyronine
Intervention type(s): Drug
Intervention description(s): 50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: hypothyroidism, quality og life, depression
Exploration of the Appropriate Combination of Positive End Expiratory Pressure and Tidal Volume Using the Intratidal Compliance Volume Profile in Children
Condition: Respiratory Compliance
Study type: Interventional

Summary: 
      In children under 6 years of age undergoing regular surgery during general anesthesia, the
      intratidal compliance profile is evaluated when different tidal volumes are applied at
      different positive end expiratory pressures.

      Then determine the most appropriate combination of positive end-tidal pressure and tidal
      volume.
    


Intervention name(s): Changes in positive end-expiratory pressure and tidal volume
Intervention type(s): Other
Intervention description(s): When the patient is in the supine position 10 minutes after induction of anesthesia, the following 4 mechanical ventilator settings are applied to the patients in order.
Positive end-expiratory pressure 8 cmH2O, tidal volume 8 ml/kg Positive end-expiratory pressure 10 cmH2O, tidal volume 5 ml/kg Positive end-expiratory pressure 10 cmH2O, tidal volume 8 ml/kg Positive end-expiratory pressure 12 cmH2O, tidal volume 5 ml/kg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Hydrocortisone on Social Cognition and Memory
Condition: Individuality
Study type: Interventional

Summary: 
      The effects of hydrocortisone on cognition will be investigated.
    

Detailed description: 
      80 healthy young individuals (40 females and 40 male) will be recruited an randomized to
      either placebo or 10 mg hydrocortisone before testing. Tasks will on emotion recognition,
      memory and cognitive flexibilty will be conducted.
    

Intervention name(s): Hydrocortisone
Intervention type(s): Other
Intervention description(s): Effects of hydrocortisone compared to placebo on cognition
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: effects of cortisol on cognition
Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease
Condition: Mild Cognitive Impairment; Prodromal Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of the study is to evaluate the efficacy of AGB101 on slowing cognitive
      and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes
      (CDR-SB) score as compared with placebo in participants with mild cognitive impairment due to
      Alzheimer's Disease (MCI due to AD) also known as prodromal AD. Participants will be
      randomized to receive placebo or AGB101 (220 mg), once daily for 78 weeks. Secondary
      objectives are to assess the effect of AGB101 compared with placebo on clinical progression
      as measured by Mini-Mental State Examination (MMSE) and Functional Activities Questionnaire
      (FAQ).
    


Intervention name(s): Placebo Oral Tablet; AGB101 220 mg tablet
Intervention type(s): Drug; Drug
Intervention description(s): Placebo oral tablet; 220 mg AGB101 active compound
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
NI-0401 in Active Crohn's Disease
Condition: Moderate to Severe Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to assess the safety and tolerability of daily intravenous
      NI-0401 treatment, compared to matching placebo. And to assess the ability of NI-0401 to
      modulate the CD3 complex on T-cells.
    


Intervention name(s): NI-0401 (anti-CD3 mAB); Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 0.05 mg up to 10 mg; Placebo
Intervention MeSH terms: Muromonab-CD3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy Study Exploring the Effect of Lu AE58054 as Augmentation Therapy in Patients With Schizophrenia
Condition: Schizophrenia; Cognition
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to explore the efficacy, safety and cognitive properties of Lu
      AE58054 as augmentation therapy to risperidone in patients with schizophrenia.
    

Detailed description: 
      Lu AE58054 is a selective 5-HT6 antagonist that is currently being investigated for treatment
      of conditions of cognitive impairment associated with schizophrenia. Substantial experimental
      evidence suggests that selective 5-HT6 receptor antagonists may be effective in treating
      cognitive deficits since they have been shown to improve performance in various animal models
      of cognitive function and are known to enhance cholinergic and glutaminergic neuronal
      function.

      Lu AE58054 has been investigated in healthy volunteers and patients with schizophrenia, is
      generally well tolerated and has a benign side-effect profile. Moreover, no safety concerns
      or issues have been identified to date.

      The study is designed to provide data on the efficacy, safety and cognitive properties of Lu
      AE58054 as augmentation therapy to risperidone in patients with schizophrenia. Efficacy will
      be assessed in patients who are in a stable phase of their illness, but with a predefined
      minimum and maximum level of symptoms that will allow them to be included in the study.
      Patients will be randomly assigned to receive either the investigational medicinal product
      (IMP) or placebo as add-on therapy to their existing risperidone treatment.
    

Intervention name(s): Lu AE58054; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): twice daily oral dose (60 mg BID: total dose 120 mg/day); twice daily oral dose
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognition; BACS; Risperidone; Augmentation therapy; Add-on therapy; Lu AE58054
Ulcer Prevention II
Condition: NSAID Associated Gastric Ulcers
MeSH terms: Stomach Ulcer; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This
      study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with
      either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.
    


Intervention name(s): Esomeprazole; Esomeprazole; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20mg oral capsule daily; 40mg oral capsule daily
Other intervention name(s): Nexium; Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: NSAID, Nexium, esomeprazole, Gastric Ulcers
Prospective Study of the Natural History of Patients With Type 2 and 3 Spinal Muscular Atrophy
Condition: Type 2 Spinal Muscular Atrophy; Type 3 Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional

Summary: 
      NatHis-SMA is a prospective, longitudinal and interventional study of the natural history of
      patients with type 2 and 3 Spinal Muscular Atrophy (SMA). The purpose of this study is to
      characterize the disease course over 2 years and identify prognostic variables of the disease
      and biomarkers of SMA progression, as well as determine the best outcome measures for further
      therapeutics approaches.
    


Intervention name(s): Strength, function and activity measurements; Muscle MRI; Electrophysiology measurements; Blood sampling for biomarker analysis
Intervention type(s): Other; Other; Other; Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: SMA; Spinal Muscular Atrophy; Neuromuscular disease