bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy
Condition: Birch Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, double-blind placebo-controlled phase I study to investigate the safety and
      tolerability of ascending doses of DM-101 in adult subjects with birch pollen allergy.
    

Detailed description: 
      The study will be carried out in a single study site located in Finland.
    

Intervention name(s): DM-101; Placebo to match DM-101
Intervention type(s): Biological; Biological
Intervention description(s): DM-101 administered by subcutaneous (SC) injection; Placebo to match DM-101 administered by SC injection
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 4 sequential study cohorts with ascending DM-101 doses. In each cohort two treatment arms: placebo and active drug
Masking: Double (Participant, Investigator)
Primary purpose: Other
Adipose Expression of Leptin, Adiponectin and IL-6 and Plasma Levels of Adipocytokines in Women With and Without Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of the study was to investigate adipose expression and plasma levels of different
      adipocytokine, which may play a role in the pathophysiology of PCOS. The investigators
      investigated lean and obese women with and without PCOS.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Lean and obese women with and without PCOS, age 18-40 years.
      
Biospecimen description: 
      Fat biopsies, plasma
Online Treatment of Trichotillomania
Condition: Trichotillomania; Alexithymia; Quality of Life
MeSH terms: Trichotillomania; Affective Symptoms
Study type: Interventional

Summary: 
      Online study for patients with trichotillomania. 4 main hypothesis.

        1. Alexithymia and Trichotillomania correlated and regression analyses find association
           between them

        2. we will be able to find patient who have never been treated before. Those will suffer to
           the same amount as previously treated patients

        3. Decoupling will be more helpful than progressive muscle relaxation

        4. different constructs of emotion regulation will show different trait and state
           characteristics in patients with trichotillomania
    

Detailed description: 
      Randomized controlled trial with about 100 participants.
    

Intervention name(s): Decoupling; Progressive relaxation
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: trichotillomania; online therapy
Investigation of Factors Affecting Children's Attitudes Towards Peers With Disability
Condition: Disability Physical
Study type: Observational

Summary: 
      Children with disabilities can be exposed to stigma and discrimination because of poor
      attitudes. The role of peer is crucial for development of disabled children.

      The aim of the study was to investigate the attitudes of children towards their peers with
      disabilities and to identify factors associated with them.

      1305 elementary school students included to the study. The students participating in the
      study, 48.9% (534) were female, 51.1% (558) were male. The Chedoke-McMaster Attitudes towards
      Children with Handicaps (CATCH) scale was used to investigate the children's attitudes.
    

Detailed description: 
      -  Being important in terms of epidemiological investigation.

        -  Giving new results from society with different cultural and national characteristics.

        -  Investigating the three components of the CATCH.
    

Intervention name(s): implementation of CATCH scale
Intervention type(s): Other
Intervention description(s): subject completed the CATCH scale
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1305 elementary school students (aged 11-14 years and grades 5-8) included to the study
        from 6 public and 2 private schools. The students participating in the study, 48.9% (534)
        were female, 51.1% (558) were male.
      
Keywords: attitude; CATCH; children; disability; peers
Bioequivalence Study of Mirabegron From Bladogra 25 mg Extended Release Tablets (Multi-Apex for Pharmaceutical Industries, Egypt) Versus Myrbetriq 25 mg Extended Release Tablets (Marketed by Astellas Pharma US, Inc, Product of Japan)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label randomized, single dose, three way three sequence two treatment partial
      replicate crossover study to determine the bioequivalence of Mirabegron from Bladogra 50 mg
      Extended Release film coated tablets (Man by Multi-Apex for pharmaceutical Industries -S.A.E
      for Apex pharma company, Egypt) and Myrbetriq 50 mg Extended Release tablets (Marketed by
      Astellas Pharma US, Inc, Product of Japan) after a single oral dose administration of each to
      healthy adults under fasting conditions.
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, Truncated AUC0→t Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, Truncated AUC0→t and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      Truncated AUC0→t to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Bladogra; Myrbetriq (first dosing); Myrbetriq (second dosing)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet contains 25 mg Mirabegron; 1 tablet contains 25 mg Mirabegron; 1 tablet contains 25 mg Mirabegron
Other intervention name(s): Myrbetriq; Myrbetriq; Myrbetriq
Intervention MeSH terms: Mirabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: three way three sequence two treatment partial replicate crossover bioequivalence study
Masking: None (Open Label)
Primary purpose: Other
Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine
Condition: Anesthesia
Study type: Interventional

Summary: 
      The goal of this Randomized Control Trial is to compare the effects of addition of
      cisatracurium to lignocaine for IVRA Vs. Plain lignocaine in All ASA physical status I & II
      patients between 20 to 55 years of age, scheduled for elective hand surgery (carpal tunnel,
      trigger finger, tendon release, fracture reduction and tendon repair). The main question[s]
      it aims to answer are: • Does addition of Cisatracurium to plain lignocaine improve the
      overall quality of anesthesia? • Does use of cisatracurium lead to improved postop analgesia
      and decreased parenteral analgesic requirements? Participants will be Forty-four patients
      undergoing elective hand surgery during IVRA randomly assigned to two groups of 22 patients
      each. All demographic details (age, gender, body weight) will be noted, all will be briefed
      about visual analogue score (0 to 10) for pain. Group 1 (control group) will receive
      lidocaine 2% diluted with saline, group 2 (cisatracurium group) will receive cisatracurium
      plus lidocaine 2% diluted with saline. A standard technique would be employed for IVRA. The
      following parameters to be assessed: onset and offset of sensory and motor block,
      Intra-operative pain at 5, 10, 20, 30 minutes after tourniquet application by using visual
      analogue score (VAS), and postoperative pain using visual analogue score (VAS) measured at
      5-minute,1, 2, 4, 8 hours postoperatively.
    


Intervention name(s): Cisatracurium Besylate; Lignocaine
Intervention type(s): Drug; Drug
Intervention description(s): Addition of cisatracurium to plain lignocaine for IVRA.; Plain Lignocaine for IVRA
Intervention MeSH terms: Lidocaine; Cisatracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cisatracurium; Intravenous Regional Anesthesia; Lignocaine
Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg)
Condition: HIV-1-infection
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The rationale for this study is to evaluate and understand the variability of a generic
      alternative of abacavir, dolutegravir and lamivudine dispersible tablets for PEPFAR
      submission to aide in the development of pivotal studies.
    

Detailed description: 
      This study is to investigate the bioequivalence of Mylan's abacavir, dolutegravir and
      lamivudine dispersible tablets, 60 mg/5 mg/30 mg to ViiV's Triumeq Dispersible Tablets (5 mg
      GSK1349572 [dolutegravir]/ 60 mg abacavir/ 30 mg lamivudine) following administration of a
      single, oral 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg) dose of Mylan's abacavir, dolutegravir
      and lamivudine dispersible tablets or ViiV's Triumeq Dispersible Tablets administered under
      fasting and fed conditions.

      Adverse events will be monitored to ensure the safety and well-being of the healthy
      volunteers.
    

Intervention name(s): abacavir, dolutegravir and lamivudine dispersible tablets; Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Abacavir, Dolutegravir and Lamivudine Dispersible Tablets, 60 mg/5 mg/30 mg Dose: 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg); Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine Dose: 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg)
Other intervention name(s): fixed combination; Triumeq
Intervention MeSH terms: Lamivudine; Abacavir; Dideoxynucleosides; Dolutegravir; Abacavir, dolutegravir, and lamivudine drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-dose, randomized, two-period, two-treatment, two-group, crossover study.
Masking: None (Open Label)
Primary purpose: Treatment
Sucralose in Subjects With Diabetes Mellitus Insulin Requesting
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To evaluate the acute effect of a preload of sucralose in presence of carbohydrate (HC)
      available on the glycemic response, postprandial C peptide and satiety in patients with type
      2 diabetes mellitus (DM2) in intensive insulin therapy (IIT).
    


Intervention name(s): Sucralose; Placebo
Intervention type(s): Other; Other
Intervention description(s): Subjects drank 200 mL of water with 14 mg sucralose, followed by a standard breakfast.; Subjects drank 200 mL of water alone (placebo), followed by a standard breakfast.
Other intervention name(s): Water
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: GLYCEMIA; SATIETY; C PEPTIDE; PRELOAD; INSULIN
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects
Condition: Pharmacokinetics of Fidaxomicin; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)
      of single and multiple ascending doses of fidaxomicin in healthy subjects. This study will
      also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in
      healthy Japanese and Caucasian subjects.
    

Detailed description: 
      Eligible subjects will check into the unit on Day-2 and remain confined to the clinical unit
      until Day 17.

      Cohorts 2 and 3, which may run in parallel, will only be enrolled after review of the
      available safety data of Cohort 1 by the Safety Review Team.
    

Intervention name(s): Fidaxomicin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): OPT-80; Dificlir; Dificid
Intervention MeSH terms: Fidaxomicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Fidaxomicin; OPT-80; Healthy Subjects
Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory
Condition: Cavernous Sinus Meningioma; Pituitary Adenoma
MeSH terms: Adenoma; Meningioma; Pituitary Neoplasms; Pituitary Diseases
Study type: Interventional

Summary: 
      Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It
      was observed that durable memory impairments could arise at irradiated patients if
      radiotherapy is applied on medial temporal lobes.

      However, results concerned studies of anterograde memory and none, this day, estimates the
      impact of radiotherapy on autobiographical memory which also involves hippocampus.

      The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation
      on autobiographical memory.

      Thirty 35 to 65 years old patients, with cavernous sinus meningioma or pituitary adenoma for
      who radiotherapy is indicated will be recruited.
    

Detailed description: 
      Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It
      was observed that durable memory impairments could arise at irradiated patients if
      radiotherapy is applied on medial temporal lobes. However, results concerned studies of
      anterograde memory and none, this day, estimates the impact of radiotherapy on
      autobiographical memory which also involves hippocampus, as specified in Nadel and Moscovitch
      model, the Multiple Trace Theory.

      Autobiographical memory impairment issue is fundamental for identity construction. Prevent
      those impairments is important to quality of life improvement after such treatments.

      The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation
      on autobiographical memory.

      A pilot study was conducted with 10 patients affected by left cavernous sinus meningioma
      divided in two groups: the first one with untreated patients and the second one with patients
      who received cavernous sinus irradiation between 2 and 5 years before pilot study. This study
      indicated autobiographical memory deterioration in two groups and a worsening in treated
      group. Study limits did not allow us to draw conclusions. That is why, sample size will be
      extended and patients with cavernous sinus meningioma or pituitary adenoma will be recruited
      because of proximity between cavernous sinus, pituitary gland and hippocampus. Investigators
      wish to recruit 30 patients with cavernous sinus and meningioma.

      Investigators hope for confirm our results from pilot study.
    

Intervention name(s): Evaluation of autobiographical memory
Intervention type(s): Other
Intervention description(s): Patients will answer several questionnaires one and two years after irradiation treatment end.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cavernous sinus meningioma; Pituitary adenoma; Hippocampus; Irradiation; Autobiographical memory
A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)
      affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how
      the drug affects the body) of a single dose of glyburide.
    

Detailed description: 
      This study will be an open-label (all volunteers and study staff know the identity of the
      assigned treatment), single-center, fixed-sequence study (all volunteers receive the same
      medication on the same days) to determine how canagliflozin (a drug currently being
      investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics and
      pharmacodynamics of glyburide (a blood glucose-lowering agent used to treat patients with
      diabetes). The study will consist of 3 phases; a screening phase, an open-label treatment
      phase, and an end-of-study (or follow-up) phase. During the open-label treatment phase, each
      volunteer will receive a single 1.25 mg dose of glyburide on Day 1, followed by 200 mg
      canagliflozin once daily on Days 4 through 8. On Day 9 volunteers will receive both glyburide
      1.25 mg and canagliflozin 200 mg. Each volunteer will participate in the study for
      approximately 40 days.
    

Intervention name(s): Glyburide; Canagliflozin (JNJ-28431754)
Intervention type(s): Drug; Drug
Intervention description(s): One 1.25 mg tablet taken orally (by mouth) on Day 1 and Day 9.; One 200 mg tablet taken orally (by mouth) on Days 4 through 9.
Other intervention name(s): Micronase; JNJ-28431754
Intervention MeSH terms: Canagliflozin; Glyburide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Pharmacodynamics; Glyburide (MICRONASE)
Effects of Cultura Yoghurt in Relation to Transit Time and Digestive Discomfort in Healthy Women and Men
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of cultura yoghurt on transit time and
      digestive discomfort during 2 weeks of treatment in comparison to placebo in healthy women
      and men.
    

Detailed description: 
      Transit time is the time it takes for a substance to pass through the gut. The major part of
      the transit is spent in the large bowel is therefore mainly a colonic event. It has been
      observed that slow transit time is associated with high prevalence of large bowel disorders.
      The objectives of this study is to:

        -  determine the effect on mean transit time after 2 weeks intake of a investigational
           products using radio-opaque sulphate impregnated polyethylene pellets as markers.

        -  determine effect of investigational products on total symptom score according to Bristol
           Stool Form (BSF)

        -  determine effect of investigational products in gastrointestinal symptoms

        -  determine safety of intake of the investigational products
    

Intervention name(s): Cultura L casei F19, acidophilus La5 , B lactis Bb 12; Yoghurt without probiotics
Intervention type(s): Other; Other
Intervention description(s): 2 weeks consumption,250 ml/day; Yoghurt without probiotics
Other intervention name(s): Cultura probiotic yoghurt; Yoghurt without prbiotics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Transit time; constipation; gut regularity; defecation frequency; Colonic transit time
Rilonacept in Diabetes Mellitus Type 1: Safety Study
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done to see if an investigational drug called rilonacept is safe to use
      in patients with type 1 diabetes, and if it can slow the loss of the body's ability to
      secrete insulin in patients who are still able to make a small amount of insulin.
    


Intervention name(s): Rilonacept
Intervention type(s): Drug
Intervention description(s): Rilonacept given subcutaneously, dose per package labeling, once weekly.
Other intervention name(s): Arcalyst, IL-1 Trap
Intervention MeSH terms: Rilonacept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interleukin 1; Type 1 diabetes mellitus; Rilonacept; Arcalyst
Home Neuromodulation of the Neurogenic Bladder in Chronic Spinal Cord Injury With Transcutaneous Tibial Nerve Stimulation
Condition: Chronic Spinal Cord Injury; Neurogenic Bowel
MeSH terms: Neurogenic Bowel; Spinal Cord Injuries; Urinary Bladder, Neurogenic; Wounds and Injuries
Study type: Interventional

Summary: 
      Determine the safety, feasibility, compliance, and efficacy of a daily home TTNS protocol in
      chronic SCI provided by self or caregiver for 4 weeks.
    

Detailed description: 
      In Specific Aim 1, we will monitor for safety, feasibility, and compliance of a home TTNS
      program for bladder management. In Specific Aim 2, the efficacy of home TTNS will be compared
      to baseline Incontinence- Quality of Life questionnaire. A bladder diary will also capture
      important information such as frequency and volume of catheterization, incontinence episodes,
      and other related observations.
    

Intervention name(s): 4-week TTNS home-based protocol
Intervention type(s): Device
Intervention description(s): 4-week TTNS home-based protocol. Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is not contraction seen, maximal tolerable intensity will be used.
In addition, if the patient perceives pain, the intensity will be lowered until comfortable.
Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: electric stimulation
Use of Lidocaine in Rapid Sequence Induction
Condition: Hemodynamic Response
Study type: Interventional

Summary: 
      Lidocaine has been shown to blunt the cardiovascular response to endotracheal intubation. The
      incidence of hypertension, tachycardia and dysrhythmias due to laryngoscopy may be increased
      in patients that receive rapid sequence induction and intubation, where opioids are spared
      and intravenous anesthetic agents are not titrated step by step. Our hypothesis was that
      lidocaine when administered intravenously in patients who undergo rapid sequence induction
      may not only blunt the hemodynamic response to intubation, but may also increase the
      anesthetic depth (as assessed by BIS), thus further reducing the possibility of hypertension,
      arrhythmias and also awareness.
    


Intervention name(s): Lidocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): lidocaine 1.5 mg/kg intravenously; normal saline
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: lidocaine; anesthetic depth; hemodynamics; rapid sequence induction; BIS