bioihbjkbjnl/mcl2 huggingface dataset:
Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus
      placebo in patients with bipolar depression.
    


Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.; Tablets, Oral, 0 mg, Once daily, 8 weeks.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bipolar 1 Disorder, depressed
Effects of ReWin(d) Supplementation on the Recovery of DOMS Induced by Acute Exercice
Condition: Muscle Soreness; Delayed-onset Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will assess the recovery and performance of young athletes suffering from muscle
      damage induced by physical exercise. Model by comparing the safety and efficacy of ReWin(d)
      supplemention during 4 weeks to placebo over 72 hours post exercice.
    

Detailed description: 
      Double-blind, randomized, placebo controlled, parallel group, pilot safety and efficacy
      study.

      40 healthy young male athetes were randomly assigned to the ReWin(d) or Placebo group. After
      4 weeks supplementation (either 2 g daily of ReWin(d) capsules or placebo capsules). the
      participants were subjected to a 1 hour plyometric exercise session to induce DOMS. At 0
      hours, 24 hours, 48 hours and 72 hours post exercise, the volunteers have been assessed to
      determine: (i) pain perception, (ii) fatigue rate, (iii) sport performance (effectiveness of
      a jump) and (iv) muscle damage and inflammation by I-R thermography and biomarkers
    

Intervention name(s): Polyherbal supplement: ReWin(d) vs Placebo
Intervention type(s): Dietary Supplement
Intervention description(s): Supplementation during 4 weeks + 72 hours post acute exercice
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single dose, Randomized, Double Blinded, Placebo-controlled Study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DOMS; Fatigue rate; Heart rate variability; Pain; Jump performance
Resin Infiltration Treatment for MIH
Condition: Molar Incisor Hypomineralization; Enamel Hypoplasia; Enamel Caries; Anterior Teeth
MeSH terms: Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

Summary: 
      The investigators aimed to evaluate changes in mineralisation degree, colour, and size of the
      lesion after Icon® in permanent teeth with MIH in 6 months.
    

Detailed description: 
      A total of 116 permanent central teeth of 37 patients were included in the study. Icon® was
      applied to teeth with MIH, while the healthy teeth received no treatment (control).

      Group I : Icon® resin infiltration treatment was performed on 58 permanent central teeth with
      MIH and evaluated before; immediately after; and 1, 3, and 6 months after the procedure.

      Group II (Control Group): No treatment was performed on healthy teeth. However, similar to
      the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated
      before; immediately after; and 1, 3, and 6 months after the procedure.

      Lesions were evaluated before, immediately after, and 1, 3, and 6 months after treatment.
      Mineralisation degree of MIH lesions was evaluated using DIAGNOdent Pen, changes in the
      lesion colour and lesion size were evaluated using VITA EasyShade and the cross polarization
      technique, respectively.
    

Intervention name(s): Resin infiltration
Intervention type(s): Procedure
Intervention description(s): A sufficient amount of HCl was applied to the lesion using the icon etch syringe included in the set and was allowed to sit for 2 minutes. After washing with water for 30 seconds, the tooth was dried using an air spray. Once the enamel surface appeared chalky, Icon® dry application was initiated.
Ethanol was applied to the lesion using the Icon® dry syringe included in the set, and after 30 seconds it was dried using an air spray. Sufficient amount of resin infiltrant was applied to the lesion using the Icon® infiltrant syringe. The resin infiltrant was applied to the lesion surface by massaging with the tip of the syringe in circular movements for 3 minutes such that it penetrates the surface thoroughly. The resin infiltrant was polymerized for 40 seconds with a light device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: molar incisor hypomineralisation; resin infiltration; discoloration; enamel; lesion
Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma
Condition: Lymphoma, T-Cell
MeSH terms: Lymphoma; Lymphoma, T-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma
      (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain
      disease-free. The efficacy of the conventional anthracycline-based chemotherapy
      (cyclophosphamide, doxorubicin, vincristine, prednisone [CHOPP]) has been unsatisfactory.

      The optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal
      dose, sequence, and multi-modality treatment with involved field radiotherapy still need to
      be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with
      cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized
      NK/T-cell lymphoma patients.
    


Intervention name(s): Concurrent Radiotherapy (RT)/cisplatin, VIPD
Intervention type(s): Drug
Intervention MeSH terms: Cisplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma, NK/T-Cell
Burn Healing and Analgesia With Propranolol
Condition: Burns; Pain
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the ability of propranolol to decrease pain and
      improve recovery in burn patients with a common genotype.
    


Intervention name(s): Propranolol; Placebo; Propanolol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40 mg; sugar pill; 120 mg twice per day
Other intervention name(s): Inderal; Innopran; Sugar pill; Inderal; Innopran
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Burns; Pain
Effect of Ghrelin on Sympathetic Nervous System
Condition: Healthy; Obesity
Study type: Interventional

Summary: 
      Ghrelin is a newly discovered peptide that is secreted by the stomach. Its main role is to
      stimulate food intake but recent studies indicate that it also acts on the cardiovascular
      system to confer beneficial effects. The mechanism of action is unclear but experimental
      studies suggest that ghrelin decreases the sympathetic nervous system. Beside there is new
      evidence in animal models that ghrelin may also be involved in stress reaction as ghrelin
      injection seems to protect against symptoms of stress. Given that circulating levels of
      ghrelin are reduced in obesity, this suggests that the effect of ghrelin may differ between
      lean and obese subjects. Ghrelin could represent an attractive therapeutic strategy for the
      treatment of cardiovascular diseases. The aim of the study if to gain more knowledge of the
      effect of ghrelin on the sympathetic nervous system and stress reactivity in both lean and
      obese subjects.
    

Detailed description: 
      This study will investigate the effect of intravenous administration of ghrelin on blood
      pressure, heart rate, muscle sympathetic nervous activity and baroreflex control in lean and
      obese individuals and will investigate whether ghrelin administration can influence the
      response to stress. Both lean and obese individuals will be recruited and will receive an
      intravenous administration of ghrelin at increasing doses for 1 hour. Their blood pressure,
      heart rate and sympathetic activity (small recording electrode in the peroneal nerve) will be
      recorded and subjects will be submitted to a mental arithmetic stress towards the end of the
      infusion. Blood samples will be taken at regular intervals for various metabolic tests. These
      responses will be compared to those when submitted to saline infusion.
    

Intervention name(s): ghrelin
Intervention type(s): Drug
Intervention description(s): 0.1 microgram/kg/min, intravenous for 60 minutes
Other intervention name(s): Ghrelin (human) acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized study evaluates the usefulness of the I31 probiotic formula, alone or in
      combination with alverine/simethicone, against placebo, in the treatment of
      diarrhea-predominant or mixed irritable bowel syndrome
    

Detailed description: 
      Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disease in which recurrent
      abdominal pain is associated with defecation or a change in bowel habits. Disordered bowel
      habits are typically present (ie, constipation, diarrhea, or a mix of constipation and
      diarrhea), as are symptoms of abdominal bloating/distention.

      I31 is a probiotic formula composed of strains Pediococcus acidilactici CECT7483 and
      Lactobacillus plantarum CECT7484 and CECT7485, previously shown to improve quality of life in
      patients with IBS of Caucasian descent.

      Alverine/simethicone is a combination of two drugs: Alverine citrate relaxes muscle cramps
      that occur in the intestine in conditions such as irritable bowel syndrome and
      diverticulosis. Simethicone is an antifoam administered orally. Reduces gas formation and
      facilitates its elimination from the digestive tract
    

Intervention name(s): I31 probiotic; I31 probiotic combined to Alverine/Simethicone; Placebo
Intervention type(s): Dietary Supplement; Combination Product; Other
Intervention description(s): I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d); I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)
Antispasmodic/antifoam drug, consisting of Alverine Citrate 60 mg and Simethicone 300 mg, thrice daily (t.i.d); Placebo treatment (maltodextrin), once daily (u.i.d)
Intervention MeSH terms: Simethicone; Alverine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Probiotic; Antispasmodic; Rome-IV
Can Genetics Predict Treatment Response to a Computerized Self-help Program for Depression?
Condition: Major Depressive Disorder; Mood Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mood Disorders
Study type: Interventional

Summary: 
      The goal of this project is to determine whether genetic information can be used to predict
      response to an internet-based treatment of depression. Several studies now indicate that
      completing an internet-based treatment for depression, called Deprexis, can significantly
      improve symptoms of depression. However, not everyone improves. The purpose of this study is
      to determine whether genetic profile can predict who is likely to improve.
    


Intervention name(s): Computerized self-help program for depression
Intervention type(s): Behavioral
Intervention description(s): For 8 weeks, participants will engage in a computerized self-help program for depression, called deprexis. This program consists of 10 content modules representing different psychotherapeutic approaches broadly consistent with a cognitive-behavioral perspective. Modules are organized as simulated dialogues in which the program explains and illustrates concepts and techniques, engages the user in exercises, and continuously asks users to respond by selecting from response options. Subsequent content is then tailored to the users' responses, resulting in a simulated conversational flow. Participants can access the self-help program as often as they would like and since it is self-guided, they will determine how often they access the material. Each module can be completed in 10 to 60 minutes, depending on the user's reading speed, interest, motivation, and individual path through the program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mood Disorders; Depression; Genetics; Treatment response; Treatment study
Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety and efficacy of PN2034 in insulin-dependent
      type 2 diabetics as measured by the change in average daily insulin dose from baseline to
      week 12. The effects of PN2034 on HbA1c, fasting plasma glucose (FPG), and lipid levels will
      also be measured.
    


Intervention name(s): PN2034; Insulin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: diabetes, type 2
Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)
Condition: Allergy; Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to evaluate the clinical effectiveness of the administration
      of a depigmented and polymerized allergen extract of Olea europaea in the rhinitis or
      allergic rhinoconjunctivitis
    

Detailed description: 
      Immunotherapy is a specific treatment for allergic diseases. Unlike conventional
      pharmacological treatment, immunotherapy is the only treatment that could modify the natural
      course of allergic disease. This is a prospective double-blind placebo controlled study with
      two arms of treatment: placebo and active.
    

Intervention name(s): Immunotherapy with modified extract of O. europaea pollen
Intervention type(s): Biological
Intervention description(s): Sublingual (2 drops daily during 2 months)
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Immunotherapy; Allergoid; Depigmented; Polymerized; Allergen-extract; Rhinoconjunctivitis
Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Demonstrate bioequivalence of guaifenesin in Mucinex® extended release (ER) 600 mg tablet in
      normal healthy volunteers compared to the immediate release guaifenesin 200 mg tablet
      reference product marketed
    


Intervention name(s): Mucinex®
Intervention type(s): Drug
Intervention description(s): Mucinex® 600 mg single dose ER bi-layer tablet
Other intervention name(s): guaifenesin
Intervention MeSH terms: Guaifenesin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2-Way Crossover
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia
Condition: Diabetes Mellitus, Type 2; Hypertriglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in
      subjects with type 2 Diabetes combined with hyperlipidemia
    


Intervention name(s): Omega-3-acids ethylesters 90 4g; Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin
Intervention type(s): Drug; Drug
Other intervention name(s): Omacor Soft Capsule 4g
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Simvastatin; Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients
Condition: OCD
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Observational

Summary: 
      To modeling the pharmacokinetic-pharmacodynamic(PK-PD) simulation with the plasma
      concentration and the transporter occupancy from OCD patients treated with escitalopram.

      To examine the effect of G2677T/A single nucleotide polymorphism(SNP) of ABCB1 gene to the
      PK-PD modeling in OCD patients treated with escitalopram.
    

Detailed description: 
      To measure plasma concentration of escitalopram in OCD patients treated with escitalopram.

      To measure serotonin transporter occupancy by escitalopram in OCD patients treated with
      escitalopram.

      To genotype G2677T/A SNP of ABCB1 gene in OCD patients treated with escitalopram.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        OCD patients
      
Biospecimen description: 
      blood sample
Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study
Condition: Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Observational

Summary: 
      The objective of this multisite study is to evaluate the performance of the Nucleus Freedom
      cochlear implant system in a large population of sequentially implanted pediatric subjects.
    

Detailed description: 
      The proposed study will include 50 pediatric subjects ages 1 year to 17 years, 11 months of
      age, implanted at up to 5 sites in the United States and Canada. The estimated duration of
      this multisite study is 18 to 24 months. The duration of individual subject participation is
      not to exceed 12 months.

      The study will be conducted as a within-subject repeated measures experiment (in which each
      subject serves as his or her own control) in order to accommodate the heterogeneity that is
      well known to characterize hearing-impaired populations
    

Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        Children with bilateral severe to profound sensorineural hearing loss who undergo
        implantation with the Nucleus Freedom Cochlear Implant System
      
Keywords: Bilateral severe to profound sensorineural hearing loss
Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and reactogenicity of candidate gD
      vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in
      these subjects will also be evaluated.
    

Detailed description: 
      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham
    

Intervention name(s): Herpes simplex candidate (gD) vaccine GSK208141
Intervention type(s): Biological
Intervention description(s): Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Herpes simplex; Herpes simplex candidate (gD) vaccine
Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer
Condition: Head and Neck Cancer; Oral Complications
MeSH terms: Head and Neck Neoplasms; Mucositis
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as
      pilocarpine may protect normal cells from the side effects of radiation therapy. It is not
      yet known if pilocarpine may be effective in preventing mucositis and dry mouth in patients
      receiving radiation therapy for head and neck cancer.

      PURPOSE: Randomized, double-blinded, phase III trial to study the effectiveness of
      pilocarpine in preventing mucositis and dry mouth in patients receiving radiation therapy for
      head and neck cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine whether prophylactic use of pilocarpine can shelter unstimulated and
      stimulated whole salivary flow in patients with head and neck cancer. II. Determine whether
      prophylactic use of pilocarpine can moderate xerostomia in these patients. III. Determine
      whether prophylactic use of pilocarpine can reduce the grade and duration of radiation
      induced mucositis in these patients. IV. Evaluate quality of life outcomes between patients
      receiving pilocarpine versus placebo. V. Evaluate the impact of xerostomia on patients
      receiving irradiation to the head and neck.

      OUTLINE: This is a randomized, double blind study. Patients receive a central axis midplane
      dose of radiotherapy five days per week over 6 to 7 weeks. Oral pilocarpine or placebo is
      administered beginning 3 days prior to radiotherapy, one tablet four times per day for three
      months. A tablet will be taken 45-60 minutes before radiotherapy. After three months, and
      after a 3-4 day rest period, all patients receive non blinded pilocarpine for an additional
      three month period. Patients are followed at weeks 4, 13, and 26 after the start of
      radiotherapy.

      PROJECTED ACCRUAL: A total of 244 patients will be accrued (122 per treatment arm).
    

Intervention name(s): pilocarpine hydrochloride; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 5mg pilocarpine hydrochloride tablets
Intervention MeSH terms: Pilocarpine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: oral complications; lip and oral cavity squamous cell carcinoma; oropharyngeal squamous cell carcinoma