bioihbjkbjnl/mcl2 huggingface dataset:
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core Study
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra
      (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who
      completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical
      response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra
      8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.
    


Intervention name(s): tocilizumab [RoActemra/Actemra]
Intervention type(s): Drug
Intervention description(s): 8 mg/kg iv every 4 weeks, 104 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device
Condition: Hearing Impairment
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      Before they are born, babies are protected from hearing very loud noises by their mother's
      bodies. After delivery, they are exposed to many loud noises that are potentially harmful.
      These noises happen in the neonatal intensive care unit (NICU). The purpose of this research
      project is to test the fit and the ease-of-use of a new device that may protect infant's
      hearing in the NICU.
    

Detailed description: 
      Despite the best efforts of Neonatal Intensive Care Unit (NICU) caregivers, vulnerable and
      fragile NICU patients are frequently exposed to noxious levels of noise from monitoring and
      respiratory equipment alarms, as well as from routine NICU care practices. Particularly
      detrimental to sleep and auditory development are patient exposures to high frequency noises
      that are specifically designed to alert NICU caregivers to important changes in patient
      status. This pilot study will help evaluate the fit, ergonomic design and the ease-of-use of
      a novel hearing protection system (special ear-muffs along with a unique attachment
      mechanism) specifically designed top diminish the transmission of high frequency noises to
      patients within the NICU, while allowing some transmission of low frequency sounds, such as a
      mother's voice.
    

Intervention name(s): NEATCAP
Intervention type(s): Device
Intervention description(s): Neonates will be sized and fitted to wear the non-invasive novel hearing protection device over a set period of time in the NICU. Vitals will be monitored.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Improved Skin Whitening Outcomes Associated With Nicotinamide Fortified Consumption in 30 to 50- Year-old Women
Condition: Skin Darken
Study type: Interventional

Summary: 
      The goal of this clinical trial is to study whether the products with nicotinamide fortified
      could improve skin whitening in 30 to 50-year-old women.

      Partipants will be randomly assigned to two study groups and use products (study product plus
      nicotinamide supplement and placebo product without nicotinamide supplement) for 2 months,
      twice a day.

      Researchers will compare the two groups whether there are significant improvement in skin
      whitening via skin measurement and analysis systems.
    

Detailed description: 
      This study is two arms, randomized, double-blind controlled trial. 70 eligible partipants at
      two study sites will be enrolled and use randomly assigned products (study product plus
      nicotinamide supplement and placebo product) for 2 months. Participants will visit the study
      site for three times on baseline day, day 30, and day 60, all relevant data will be captured,
      measured via professional skin equipment system and recorded in the data management system.
      At the end of study, the explantory and statisitcal analysis will be conducted to validate
      the assumption that the using products with nicotinamide fortified could improve skin
      whitening in 30 to 50-year-old women.
    

Intervention name(s): Wonderlab Nicotinamide Drink; Ordinary Drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants in this arm will use a bottle of 25ml each time, twice a day, for 2 months.; Participants in this arm will use a bottle of 25ml each time, twice a day, for 2 months.
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: skin whitening; nicotinamide
The Effect of Accompanying Temporomandibular Joint Dysfunction in Patients With Chronic Migraine
Condition: Chronic Migraine, Headache; Temporomandibular Joint Dysfunction; Chronic Pain; Quality of Life; Sleep; Headache
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Migraine Disorders; Chronic Pain; Headache
Study type: Interventional

Summary: 
      The aim of this clinical study to evaluate the effect of temporomandibular joint dysfunction
      accompanying patients with chronic migraine on pain, quality of life, sleep and
      functionality.
    

Detailed description: 
      Patients who applied to Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine,
      Department of Neurology, headache outpatient clinic and were diagnosed with chronic migraine
      according to the International Headache Society Classification (ICHD-3), after the patient's
      history and physical examination, will be included in the study.

      Date of birth, gender, education level, body mass index, occupation, marital status,
      socioeconomic status, age of onset of migraine complaints, descriptive information about
      migraine attacks (type (with or without aura), duration of attacks, mean number of days with
      pain) , pain intensity, accompanying) will be questioned.

      In addition, patients with complaints and findings such as pain in the temporomandibular
      joint area and chewing muscles, limitation in mouth opening, noise from the joint during
      mouth opening and/or non-harmonic jaw movements will be evaluated by Alper Mengi in terms of
      temporomandibular joint dysfunction.

      A total of 62 patients are planned to be included in the study. In the study, 2 groups will
      be formed, the first group will consist of chronic migraine patients, the second group will
      consist of patients with chronic migraine as well as temporomandibular joint dysfunction.

      All patients will be evaluated for allodynia, quality of life, headache-related disability,
      and sleep quality. Relevant forms will be filled by patients.

      Patients who are thought to have temporomandibular joint dysfunction will be evaluated by
      Alper Mengi for dysfunction.
    

Intervention name(s): Detection of Pain, Quality of Life, Sleep and Functioning; Temporomandibular joint dysfunction
Intervention type(s): Other; Other
Intervention description(s): All patients will be evaluated for allodynia, quality of life, headache-related disability, and sleep quality.; Patients with jaw complaints will be evaluated for temporomandibular joint dysfunction.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization
Condition: Coronary Occlusion; Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Coronary Occlusion
Study type: Interventional
Phase: Phase 2

Summary: 
      The test compound and subject of this clinical trial is the haemoglobin-based oxygen carrier,
      HBOC-201 (Hemopure). HBOC-201, initially developed as an alternative to red blood cells for
      surgical patients, has the ability to restore tissue oxygenation in persistently ischemic
      tissue. The development of this new class of compounds, referred to as oxygen therapeutics,
      provides an opportunity to test the safety and efficacy of a new approach to management of
      myocardial ischemia.
    

Detailed description: 
      Because of their ability to perfuse and deliver oxygen, hemoglobin-based oxygen carriers
      (HBOC) may be considered in the treatment of several ischemic conditions, such as acute
      coronary syndromes (ACS). Elective percutaneous intervention (PCI) induces transient
      myocardial ischemia due to reduction of coronary flow during balloon inflation in the
      coronary artery, thus simulating in a control setting, the occurrence of an ACS.
    

Intervention name(s): Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)
Intervention type(s): Drug
Intervention description(s): Pre-oxygenated HBOC-201
Intervention MeSH terms: Chrysarobin; HBOC 201
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Percutaneous Coronary Intervention; Myocardial Ischemia; Balloon Occlusion; Catheter Lab
Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients
Condition: Sexual Dysfunction, Physiological
MeSH terms: Sexual Dysfunction, Physiological
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical research study is to determine whether the ESTRING or a special
      preparation of a testosterone cream inserted vaginally are safe for use in breast cancer
      patients. This study will also evaluate if either of these treatments can improve symptoms of
      vaginal dryness or decreased sexual interest that are related to your treatment for breast
      cancer.
    

Detailed description: 
      There is a growing body of scientific literature to suggest that sexual functioning is one of
      the most distressing problems experienced by breast cancer survivors. Vaginal dryness,
      dyspareunia (pain during sexual intercourse), and decreased libido are common complaints
      among breast cancer patients. With increasing use of aromatase inhibitors which are
      associated with a higher rate of vaginal dryness than tamoxifen, these problems are becoming
      even more prominent. This study will evaluate the safety and tolerability of the ESTRING and
      1% testosterone cream administered vaginally as treatments for vaginal dryness and/or
      decreased libido in women receiving an aromatase inhibitor for early stage breast cancer.
    

Intervention name(s): Testosterone Cream; Estring
Intervention type(s): Drug; Drug
Intervention description(s): 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment; 2mg ring inserted vaginally once every 12 weeks
Other intervention name(s): intravaginal testosterone cream; ESTRING Estrodial Vaginal Ring
Intervention MeSH terms: Methyltestosterone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Vaginal Testosterone Cream; ESTRING
Safety and Efficacy of ALV003 for the Treatment of Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
    

Detailed description: 
      Double-blind, placebo controlled study of the efficacy, safety and tolerability of 6-weeks
      treatment of ALV003 in patients with well-controlled celiac disease. Approximately 110 biopsy
      proven celiac disease patients will be randomized to treatment with ALV003 or placebo in a
      1:1 ratio. Patients will be required to have a pre-dose and a post-treatment intestinal
      biopsy, and also will be required to ingest a foodstuff that contains a specified amount of
      gluten during the active phase of the study along with the study treatment. Patients will
      return to the clinic weekly for the first two weeks, then every two weeks thereafter for
      safety visits. Patients will return to the clinic 28 days after completion of treatment for
      final safety and follow-up. Safety will be closely monitored throughout the study including
      laboratory parameters and clinical assessment of adverse events.
    

Intervention name(s): ALV003; ALV003 placebo
Intervention type(s): Biological; Biological
Intervention description(s): ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase).; ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Celiac Disease; Coeliac Disease; Celiac Sprue; Keliakia
Internet-delivered Cognitive Behavior Therapy (CBT) for Children Age 8-12 Years With Anxiety Disorders
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether a 10 week Internet-delivered CBT is a
      feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia,
      panic disorder, specific phobia, generalized anxiety disorder or separation anxiety
      disorder). The program is directed toward both the parents and children. The patients work
      with the treatment is supported through on-line contact with a therapist. Approximately 128
      patients will be included in the study and randomized to either condition. All included
      patients are assessed before the treatment starts and after 10 weeks (post treatment).
      Follow-up assessments are conducted at 3 and 12 months after treatment.
    


Intervention name(s): therapist support; Internet-delivered CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly therapist support without CBT-interventions; Internet-delivered cognitive behavioural therapy with therapist support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive behavior therapy; Internet; Anxiety disorders; Children
Effects Of Oral Prednisolone On Bone Metabolism In Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to establish associations between blood and urine markers of bone
      metabolism with histomorphometric changes (changes in the actual bone structure) resulting
      from short term oral prednisolone treatment in patients with COPD (chronic obstructive
      pulmonary disease).
    


Intervention name(s): prednisolone
Intervention type(s): Drug
Intervention MeSH terms: Prednisolone
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; prednisolone; bone biopsy; tetracycline labelling
Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes.
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      Insulin treatment often causes the blood glucose levels to fall too low. The body usually
      responds to low blood glucose levels by releasing hormones which act against the insulin to
      help correct the low blood glucose levels. However, this hormone response can be altered in
      people with diabetes. Currently there are no therapeutic agents that can be used to improve
      the recovery from hypoglycemia (low blood sugar). The aim of this study is to determine
      whether a formoterol inhaler can be used to improve and accelerate the recovery from
      hypoglycemia in patients with type 1 diabetes.
    

Detailed description: 
      Note: Below is the original detailed description submitted in 2010. The recruitment for this
      study was stopped at 7 subjects in each study arm. The study design and outcome measures did
      not change for this study. See below for further details.

      Original: 15 subjects with well controlled type 1 diabetes and regular hypoglycemia and 15
      healthy volunteers will be recruited for this study.

      If you agree to participate in this study, you will be asked to participate in a screening at
      Yale New Haven Hospital. Each study subject will undergo two hypoglycemic clamp studies (a
      procedure where the blood sugar is closely regulated with intravenous insulin and glucose.)
      In these hypoglycemic clamp studies, the subject will be given an inhaler. On one visit the
      inhaler will contain formoterol capsules and on the other visit, the subject will be given
      'dummy' capsules. Subjects will be required to be admitted to the HRU the night before the
      study so that glucose levels can be stabilized and hypoglycemia avoided.
    

Intervention name(s): Formoterol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Formoterol inhaler, 12mcg capsules, 4 capsules for one administration; Participants in both arms received placebo on 1 of the 2 visits.
Other intervention name(s): Foradil Aerolizer
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: type 1 diabetes; hypoglycemia; formoterol
Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability and pharmacokinetics in Japanese and Caucasian subjects
      when ONO-2910 is administered as single and multiple doses orally.
    

Detailed description: 
      This study is the First in Human (FIH) study to investigate safety, tolerability and
      pharmacokinetics in healthy Japanese and Caucasian adult male subjects when ONO-2910 is
      administered as single and multiple doses orally. Also, the purpose of this study is to
      evaluate pharmacokinetics of oral single-dose of ONO-2910 in Japanese elderly male and female
      subjects.
    

Intervention name(s): ONO-2910; Placebo; ONO-2910; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single ascending dose of ONO-2910 will be administered orally.; Single dose of placebo will be administered orally.; Multiple ascending dose of ONO-2910 will be administered orally.; Multiple dose of placebo will be administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare the steady-state
      exposure of semaglutide administered subcutaneously once daily to semaglutide administered
      subcutaneously once weekly in healthy subjects.
    


Intervention name(s): semaglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin)once daily or once weekly.; Administered subcutaneously (s.c., under the skin)once daily or once weekly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Skin Test Study of BM32
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the present skin test study CS-BM32-001 is to evaluate whether the BM32 proteins
      exhibit low/no allergenic activity when applied by skin prick- and atopy patch testing to
      grass pollen allergic patients
    

Detailed description: 
      BM32 is a hypoallergenic grass pollen allergy vaccine which consists of an aluminum
      hydroxide-adsorbed equimolar mix of four active ingredients, BM321, BM322, BM325 and BM326.
      The four active ingredients are purified recombinant proteins containing non-allergenic
      peptides from the four major timothy grass pollen allergens, Phl p 1 (BM321), Phl p 2
      (BM322), Phl p 5 (BM325) and Phl p 6 (BM326) which are fused to the PreS domain of hepatitis
      B virus, a protein used in childhood vaccines. BM32 holds promise not to induce IgE mediated
      immediate type (e.g. anaphylactic reactions) or T-cell mediated late phase side effects
      during immunotherapy.

      The aim of the present skin test study CS-BM32-001 is to evaluate whether the BM32 proteins
      due to their low/absent IgE- and T cell-reactivity exhibit low/no allergenic activity when
      applied by skin prick- and atopy patch testing to grass pollen allergic patients (n=60). This
      study will therefore provide important information for immunotherapy studies based on BM32.
    

Intervention name(s): BM32
Intervention type(s): Biological
Intervention description(s): BM32 will be applied in sterile phosphate buffer solution. Drug will be applied in concentrations of 11,33 and 100 micrograms/ml
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Specific Immunotherapy; Grass pollen vaccine; Allergy; Grass Pollen Allergy
Effect of LIXIsenatide on the Renal System
Condition: Diabetic Kidney Disease; Diabetic Nephropathy; Diabetes Mellitus; Glucagon-Like Peptide 1
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Based on preclinical and small-sized studies in non-diabetic individuals, incretin-based
      therapies, i.e. glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase-4
      inhibitors, may hold promise in preventing the onset and progression of diabetic kidney
      disease. However, the potential renoprotective effects of these agents, that are believed to
      be effectuated "beyond glucose control", have not been sufficiently detailed in human
      diabetes.

      Therefore, the present study aims to explore the mechanistic and clinical effects of GLP-1
      receptor agonists on renal physiology and biomarkers in patients with type 2 diabetes.

      Forty patients with insulin-treated type 2 diabetes will undergo an eight week intervention
      with lixisenatide or insulin glulisine in order to assess changes in the outcome parameters.
    


Intervention name(s): Lixisenatide; Insulin glulisine
Intervention type(s): Drug; Drug
Intervention description(s): GLP-1 receptor agonist; Insulin analogue
Other intervention name(s): Lyxumia; Apidra
Intervention MeSH terms: Insulin glulisine; Lixisenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment