bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg,
      compared to Cetirizine and placebo for the treatment of seasonal allergic rhinitis.
    

Detailed description: 
      In this pivotal, multicentre, international, randomized, double-blind, placebo and
      active-comparator controlled, parallel study, 683 patients with SAR will be enrolled.
      Patients will be required to be 12-70 years old, have SAR for ≥2 years, a positive skin test,
      total nasal and non-nasal score (TSS) ≥36 (out of 72) during run-in, and a composite
      instantaneous nasal symptom score ≥6 (out of 12) the morning before randomization. The
      primary efficacy endpoint will be the AUC of reflective TSS from baseline to Day 14.
    

Intervention name(s): bilastine; Cetirizine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg (encapsulated) tablets QD/14days; 10 mg (encapsulated) tablets. QD/14 days; (encapsulated) Tablets QD/14 days
Other intervention name(s): Zyrtec
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rhinitis; Allergic; Seasonal; Hay Fever; Pollen Allergy; Pollinosis; Rhinoconjunctivitis
A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      HL237 is a new autoimmune therapeutic agent for rheumatoid arthritis, including the basic
      structure of biguanide in metformin, an existing diabetes drug.

      The immune modulating activity of HL237 was demonstrated in animal model. HL237 is a STAT3
      inhibitor and STAT3 is well known for an important regulator inhibiting Th17 cells and
      activating Treg cells.

      Therefore, when STAT3 activity is inhibited, it is expected to be able to treat autoimmune
      diseases such as rheumatoid arthritis.

      This is the first clinical trial to be conducted for the development of HL237 and this
      clinical trial is for determining the maximum oral dose of HL237 and assessing safety,
      tolerability, and pharmacokinetic characteristics for each dose group.
    


Intervention name(s): HL237; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Experimental; placebo with same properties except for active ingredient
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Comparison Between Different Horizontal Ridge Augmentation Techniques
Condition: Atrophic Ridge
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      Sixteen patients were selected from the Outpatient Clinic of the Oral and Maxillofacial
      Surgery Department, Faculty of Dentistry, Mansoura University for replacement of missed
      single tooth / teeth in posterior atrophic mandible by dental implant.

      Patients' grouping:

      Patients were divided randomly into two equal uniform groups as follow:

      Group I:

      Eight implants were placed in patients of missing single tooth / teeth in posterior mandible
      with subsequent horizontal ridge augmentation by decompression technique.

      Group II:

      Eight implants were placed in patients of missing single tooth / teeth in posterior mandible
      with subsequent horizontal ridge augmentation by ridge splitting technique using
      piezosurgery.

      All patients were evaluated clinically and radiographically at regular time interval
      immediately, 6 and 12 months after surgery.
    


Intervention name(s): horizontal ridge augmentation by decompression technique.; horizontal ridge augmentation by ridge splitting technique using piezosurgery.
Intervention type(s): Procedure; Procedure
Intervention description(s): Instead of a cover screw, a 2-mm healing abutment was used after implant insertion; horizontal ridge augmentation was done using piezosurgery tips and bone expanders
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Liraglutide Treatment to Patients With Severe Renal Insufficiency
Condition: Type 2 Diabetes Mellitus; End-stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Incretin-based therapy for the treatment of patients with type 2 diabetes mellitus (T2D) is
      new and fundamentally different from the classical treatments with oral antidiabetic agents
      and insulin. The novel and original aspect of this investigator-initiated study is the focus
      on treatment with an incretin-based agent (the GLP-1 analogue liraglutide) in T2D patients
      with severely reduced kidney function. At present there is virtually no knowledge of the
      physiology and clinical implications of the role of incretin hormones and incretin-based
      therapy in this group of diabetic patients.The aim of the study is to establish an
      evidence-based rationale for introducing a GLP-1 analogue to the limited armamentarium of
      antidiabetic drugs for patients with type T2D and severe renal insufficiency. The overall
      hypothesis is that patients with T2D and severe renal insufficiency will tolerate and benefit
      from treatment with the GLP-1 analogue liraglutide, hereby improving glycaemic control and
      reducing risk factors of cardiovascular disease
    


Intervention name(s): Liraglutide
Intervention type(s): Drug
Intervention description(s): Daily sc. injection, individual dosage
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Liraglutide; Uremia; Dialysis; Type 2 diabetes mellitus; Safety; Efficacy
Effects of Morphine Added to Bupivacaine in Transversus Abdominis Plane Block for Inguinal Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      This study is conducted to determine whether morphine added to bupivacaine in ultrasound
      guided (USG) transversus abdominis plane (TAP) block has beneficial effects than bupivacaine
      alone in providing postoperative analgesia for inguinal hernia surgery.
    

Detailed description: 
      Total of forty adult patients of American Society of Anaesthesiologists (ASA) physical status
      ( PS) I - II scheduled for elective inguinal hernia surgery under spinal anaesthesia were
      recruited in this study after getting written informed consent. They were randomized to
      undergo ipsilateral USG TAP block with 20 ml of 0.25 % bupivacaine (group B) versus 20 ml of
      0.25 % bupivacaine with 3 mg morphine (group BM). Patients were followed postoperatively for
      the 24 hours by a blinded investigator for monitoring of number of rescue analgesic consumed,
      duration of analgesia, numerical rating scale (NRS) at rest and on cough and any adverse
      effects.
    

Intervention name(s): bupivacaine and morphine
Intervention type(s): Combination Product
Intervention description(s): Bupivacaine group will receive 0.25% bupivacaine 20 ml in TAP block. Bupivacaine morphine group will receive 0.25% bupivacaine 20 ma with 3 mg morphine in TAP block.
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After obtaining written informed consent from a total of 40 patients fulfilling inclusion criteria will be enrolled. A 40 envelopes with number indicating the sequence of the patient on the outside and the allocated group and study drug inside will be made by an anaesthesiologist. An anaesthetic technician will prepare the study drug. The participants, clinicians and the investigator who is involved in patient assessment and collecting data postoperatively will be blinded.
The study groups received the following study medication Group B - 0.25% bupivacaine 20 ml in TAP block Group BM - 0.25% bupivacaine 20 ml with 3 mg morphine in TAP block
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TAP block,; Morphine,; Inguinal hernia
Impact of Gonadotrophin REceptor Polimorphisms on the Relationship Between Serum AMH and Ovarian Response
Condition: antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian Response
Study type: Observational

Summary: 
      Aim of study: To compare the relationship between serum AMH and ovarian response for IVF with
      the GnRH antagonist protocol in patients who are carriers of FSH and/or LH receptor
      polymorphisms with those that are not.
    

Detailed description: 
      Serum AMH has shown to have a high predictive capability of the ovarian response to
      stimulation for IVF. On the other hand, patients who are carriers of polymorphisms in the FSH
      and LH receptors, have shown to need higher doses of gonadotrophins for ovarian stimulation.
      The proportion of carriers has been described to be around 20% of the population.
      Nevertheless, the determination of these polymorphisms is not performed in routine practice.
      It is unknown if their presence affects to the relationship between serum AMH levels and
      ovarian response.

      This is a prospective, single center, non-interventional, cohorts study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infertile Patients undergoing IVF treatments
      
Biospecimen description: 
      Whole blood samples
    
Keywords: gonadotrophin receptor polymorphism; antimüllerian hormone; ovarian response; ovarian stimulation
Ablation of the Pulmonary Veins for Paroxysmal Afib
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency
      of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal
      atrial fibrillation. (PAF)
    

Detailed description: 
      This trial was a non-randomized, multi-center, prospective study of subjects with
      symptomatic, paroxysmal atrial fibrillation (PAF). The purpose of this study was to
      investigate and confirm the safety, efficacy and efficiency of the Medtronic Ablation
      Frontiers® Cardiac Ablation System when used for the treatment of paroxysmal AF. The trial
      was conducted over a 2 year period with enrollment occurring between 4 October 2007 and 1
      December 2008.
    

Intervention name(s): RF Ablation procedure
Intervention type(s): Procedure
Intervention description(s): Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study.
Other intervention name(s): Radio Frequency Ablation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation
Effects of Brain Stimulation During a Daytime Nap on Memory Consolidation in Patients With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment, So Stated
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is
      well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its
      slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory
      representations. This impact of sleep on memory performance can be additionally enhanced by
      exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the frequency
      range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in young, healthy
      subjects. If patients with amnestic mild cognitive impairment (MCI)- usually characterized by
      initial difficulties in hippocampus dependent memory functions - benefit from transcranial
      slow oscillatory stimulation (tSOS) during sleep as well has not been studied so far. The
      primary goal of the study is therefore to investigate the impact of oscillating current
      stimulation (tSOS) during a daytime nap on declarative memory consolidation in MCI patients.
    


Intervention name(s): SHAM stimulation; 0,75 Hz stimulation
Intervention type(s): Device; Device
Intervention description(s): no stimulation
Other intervention name(s): oscillating direct current brain stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: mild cognitive impairment; dementia; MCI; brain stimulation; tSOS; tDCS; sleep; nap; daytime sleep; memory; memory consolidation
A Single Oral Dose Study to Evaluate Four Different Formulations of AZD9977 and the Effect of Food in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate pharmacokinetics (PK) of four different formulations with different
      release profiles of AZD9977 (PART A) in the fasted state, and one of the formulation will be
      selected for further development (Part B). In Part B, the influence of food on the PK of
      AZD9977 will be evaluated
    

Detailed description: 
      This study is a randomized, open-label, single-center study conducted on 12 healthy male
      subjects. This consists of three periods:

        -  Screening period (only prior to Day-1)

        -  Residential/treatment period (Part A and Part B)

        -  Follow-up period (5 to 7 days after-final dose)

      The study is divided into 2 parts: Part A and B. The subjects will participate in both Part A
      and Part B. Part A will be a 4-way cross-over study to compare the PK of 3 different solid
      formulations with different release rates with an oral suspension of AZD9977 in fasting
      conditions. Subjects in Part A will receive the following treatments on Days 1, 3, 5 and 7:

        -  AZD9977 oral suspension 15 mg/mL (15 mg/mL = 195 mg) (reference)

        -  AZD9977 capsule, 65 mg (3 x 65 mg = 195 mg)

        -  AZD9977 extended release (ER) capsule, 65 mg, fast (3 x 65 mg = 195 mg)

        -  AZD9977 ER capsule, 65 mg, intermediate release (Int) (3 x 65 mg = 195 mg) Subjects will
           be resident from 1 day before Part A until at least 36 hours post last dosing in Part A.
           Subjects will return to the unit for Part B after completion of Part A. There will be a
           washout period of at least 2 days between the doses for a subject. Based on the results
           in Part A, one of the solid formulations will be selected and evaluated in fed
           conditions on Day of Part B. Subjects will return to the unit for a final study visit 5
           to 7 days post- dose in Part B. Each subject will be involved in the study for
           approximately 9 weeks.
    

Intervention name(s): AZD9977 Oral suspension (reference); AZD9977 capsule; AZD9977 ER capsule (fastvrate); AZD9977 ER capsule (Int. rate)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Randomized subjects will receive single oral dose of AZD9977 oral suspension 15 mg/mL on Days 1, 3, 5 and 7 in Part A.; Randomized subjects will receive single oral dose of AZD9977 capsule 65 mg on Days 1, 3, 5 and 7 in Part A.; Randomized subjects will receive single oral dose of AZD9977 ER capsule (fast rate) 65 mg on Days 1, 3, 5 and 7 in Part A.; Randomized subjects will receive single oral dose of AZD9977 ER capsule (Int rate) 65 mg on Days 1, 3, 5 and 7 in Part A.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart failure.; Mineralocorticoid receptor modulator.; Heart failure with preserved ejection fraction (HFpEF).
Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression
Condition: Major Depression
MeSH terms: Seizures; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators intend to test in a single center, clinical pilot efficacy study the
      primary hypothesis that Magnetic Seizure Therapy (MST) as add-on therapy to a controlled
      pharmacotherapy is efficacious in the treatment of refractory major depression assessed with
      the Hamilton Depression Rating Scale (HAMD).
    


Intervention name(s): Thymatron; Tonica MagPro MST
Intervention type(s): Device; Device
Intervention description(s): Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks; 100% power, vertex placement, 3 times per week for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare two different formulations of mirikizumab in healthy
      participants. This study will compare how much of each formulation gets into the blood stream
      and how long it takes the body to remove it. Information about any side effects that may
      occur will also be collected. Participants will remain in the study for about 12 weeks, after
      receiving study drug.
    


Intervention name(s): Mirikizumab
Intervention type(s): Drug
Intervention description(s): Reference and test formulations of mirikizumab administered as a SC injection.
Other intervention name(s): LY3074828
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy
Condition: Idiopathic Membranous Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, Membranous
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether treatment with long-acting synthetic
      adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous
      nephropathy and high for renal failure.
    


Intervention name(s): tetracosactide hexacetaat
Intervention type(s): Drug
Intervention description(s): Intramuscular injections with tetracosactide hexacetaat (Synacthen Depot) 1ml a 1mg/ml. Treatment for 9 months with an increasing dosage from once per 2 weeks to twice a week.
Other intervention name(s): Synacthen Depot, long-acting synthetic ACTH
Intervention MeSH terms: Cosyntropin; Adrenocorticotropin zinc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: high risk for ESRD; immunosuppressive treatment; membranous nephropathy; ACTH
Efficacy and Safety of SPD503 in Combination With Psychostimulants
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with
      ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years
      with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.
    


Intervention name(s): SPD503-AM; SPD503-PM; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg; SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg; Placebo matched to Guanfacine Hydrochloride Extended Release
Other intervention name(s): Intuniv; Intuniv
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Glucosanol in Maintaining Body Weight
Condition: Overweight; Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      To date, there is no clinical evidence on the efficacy and safety of Glucosanol in
      maintaining weight loss beyond the study duration of 12 weeks. The rationale for this
      open-label study is to assess the efficacy in preventing regain of loss body weight and
      safety of Glucosanol in subjects who are overweight or obese over a longer period after the
      initial weight loss.
    


Intervention name(s): Glucosanol
Intervention type(s): Device
Intervention description(s): 2 tablets taken 3 times a day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight maintenance; BMI; Body weight; Overweight; Obesity; Satiety
Correlation Between Skin Carotenoid Levels and Previous History of Skin Cancer
Condition: Skin Cancer; Basal Cell Carcinoma; Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Carcinoma, Basal Cell; Skin Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to determine the difference of skin carotenoid levels between
      subjects with previous squamous cell carcinomas (SCC), subjects with previous basal cell
      carcinomas (BCC) and a control group.
    

Detailed description: 
      There has been experimental and clinical research evaluating association of different
      carotenoids and incidence of malignancies, including Non- Melanoma Skin Cancer (NMSC). An
      easy and inexpensive way to determine which subjects would benefit from supplementation with
      carotenoids or retinoids could be the measurement of skin carotenoid levels.The least
      invasive way to perform it is through Raman spectroscopy which is a technique that uses a
      laser light that can be used to quantify carotenoids on the skin. We will compare the skin
      carotenoid levels of subjects with previous history of SCC or BCC and subjects without
      history of previous NMSC.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The research population were recruited from Massachusetts General Hospital dermatology
        clinics.
      
Keywords: Non-melanoma skin cancer; Basal cell carcinoma; Squamous cell carcinoma
Market Research - Acceptability Study for a New PKU Protein Substitute
Condition: PKU; Phenylketonurias; Inborn Errors of Metabolism; Metabolic Disease
MeSH terms: Phenylketonurias; Metabolism, Inborn Errors; Metabolic Diseases
Study type: Interventional

Summary: 
      The aim of this study is to demonstrate that a new protein substitute is acceptable and well
      tolerated in children with PKU.
    


Intervention name(s): GMPOWER
Intervention type(s): Dietary Supplement
Intervention description(s): (casein) glycomacropeptide protein substitute for the dietary management of PKU from the age of 3 years
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other