bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Cariprazine for Bipolar I Disorder
Condition: Mania; Bipolar I Disorder
MeSH terms: Mania
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy, safety, and tolerability of
      cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes
      associated with bipolar I disorder.
    


Intervention name(s): Cariprazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.; Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Mania; Bipolar I Disorder
Design and Application of Vitamin D Films for Burn Healing After Cauterizing Surgery
Condition: Nasal Obstruction
MeSH terms: Nasal Obstruction
Study type: Interventional
Phase: Early Phase 1

Summary: 
      One of this method's drawbacks is the healing of cauterized cartilage after processing. It
      was reported that the healing is so slow as no dosage form can reach this place in addition
      to the scares produced from healing is very irritable to the patient.

      From this point, the investigators start searching for a solution to this problem and reach
      the repositioning of Vitamin D3 (calciferol) as an active ingredient for the rapidity and
      efficacy of burn healing.

      The dosage form of choice that was reported before for intranasal application by the same
      team of investigators and gave good results. the intranasal films were proved for its
      convince, simplicity, efficacy, and compliance to patients.
    


Intervention name(s): Vitamin D3
Intervention type(s): Drug
Intervention description(s): intranasal film
Other intervention name(s): Calciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Docetaxel/Pemetrexed as 1st Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial will determine the maximum tolerated dose the recommended phase II dose and the
      efficacy of this combination in locally advanced or metastatic NSCLC patients
    

Detailed description: 
      Docetaxel as single-agent therapy (100 mg/m2 and 75 mg/m2, every 3 weeks) produces response
      rates of 26% to 54%. Docetaxel has proven superior compared to best supportive care (BSC) in
      chemotherapy-naïve as well as in platinum pretreated patients. In addition, docetaxel is
      active in cisplatin refractory or resistant patients, producing responses ranging from 18% to
      25%, implying a lack of cross-resistance between docetaxel and cisplatin, probably due to
      their different mechanisms of action. Furthermore, docetaxel is associated with significant
      prolongation of survival when administered as second line therapy, in pretreated patients
      with advanced NSCLC. Phase II studies of pemetrexed in previously untreated patients with
      NSCLC have demonstrated single agent response rates of 17% to 23%. A phase II study of
      pemetrexed in patients with advanced NSCLC, who had progressed during or within 3 months of
      completing first-line chemotherapy, demonstrated a response rate of 8.9% and median survival
      time of 5.7 months. Multivariate analysis established an association between an increased
      risk of severe pemetrexed toxicity and elevated homocysteine (folate and/or B12 vitamin
      deficiency marker) levels. Since December 1999, all pemetrexed-treated patients are required
      to receive folic acid and Vitamin B12. A recently reported phase III study compared
      pemetrexed with docetaxel as 2nd line therapy in patients with advanced NSCLC. Treatment with
      pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer
      side effects compared with docetaxel.
    

Intervention name(s): Docetaxel; Pemetrexed
Intervention type(s): Drug; Drug
Intervention description(s): Docetaxel at starting dose of 65 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles; Pemetrexed at starting dose of 400 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles
Other intervention name(s): Taxotere; Alimta
Intervention MeSH terms: Docetaxel; Pemetrexed
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSCLC; Pemetrexed; Docetaxel
Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety,
      tolerability and immunogenicity of three dose levels (5µg, 15µg and 45µg HA) of the novel A
      (H1N1) influenza VLP vaccine as compared with a placebo in healthy adults (18 to 64 years of
      age).
    

Detailed description: 
      The study will be conducted in two parts (A & B) at a single center in Mexico. The purpose of
      Part A is to evaluate the safety of the H1N1 VLP vaccine and to evaluate immunogenicity and
      select a dose for Part B. In Part A, 1,000 subjects will be enrolled and randomized to a
      1:1:1:1 schedule (5µg, 15µg and 45µg doses of H1N1 VLP vaccine or placebo. Subjects will
      receive two intramuscular (IM) injections (0.5mL/dose) of the H1N1 VLP vaccine or placebo 21
      days apart. Blood for HAI assays will be collected at 3 time points (baseline, Day 14 and Day
      36). Subjects will be followed for all adverse events (AEs) from the first day of the study
      through 21 days after the second dose (Day 36). Subjects will be followed for serious AEs and
      significant new medical conditions (SNMCs) to the end of the study 6 months post-dose 2 (Day
      194).

      Once the first 500 subjects are enrolled into Part A, enrollment will be halted until 3 days
      of safety follow-up data are reviewed by the study Data and Safety Monitoring Board (DSMB). A
      second data review will occur following Day 14 visit for Part A to select the dose to be
      administered in Part B.

      Part B of the study will be conducted to evaluate safety and accumulate enough safety data to
      potentially move forward with broader use of the vaccine assuming favorable results. In Part
      B, a total of 3,250 - 3,750 subjects will be randomized to receive the selected dose of H1N1
      VLP vaccine or placebo. A total of 3,000 H1N1 VLP vaccine recipients at the selected dose or
      higher, and 1,250 placebo recipients will be enrolled in Parts A and B. Following completion
      of Day 36 in Part A, data may be reviewed to assess 1 injection vs. 2 injections in Part B.
    

Intervention name(s): Placebo; A/H1N1 2009 Influenza VLP Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Two doses (Day 1 and Day 22); 0.5mL; Two doses (Day 1 & Day 22); 0.5mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: A (H1N1)
the Effect of Opioid-free General Anesthesia
Condition: Gynecologic Disease
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      This study is performed to investigate the effect of opioid-free general anesthesia on the
      recovery quality after gynecological laparoscopy.
    

Detailed description: 
      The quality of recovery after the surgery is assessed using the QoR 40. In addition, the
      various kinds of cytokine are assessed for the ancillary study.
    

Intervention name(s): Dexmedetomidine Hydrochloride; Lidocaine Hydrochloride; Remifentanil Hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): dexmedetomidine iv bolus followed by the infusion of 0.1-1 ug/kg/hr during general anesthesia; lidocaine iv bolus followed by the infusion of 1.5 mg/kg/hr during general anesthesia; remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia
Other intervention name(s): precedex; lidocaine; remifentanil
Intervention MeSH terms: Lidocaine; Dexmedetomidine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome
Condition: Sleep Apnea, Obstructive; Acute Coronary Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Respiratory Aspiration; Sleep Apnea, Obstructive; Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Obstructive sleep apnea (OSA) syndrome affects up to 5% of the general population. The
      prevalence is multiplied by 13 in coronary artery disease (CAD) patients. Many studies have
      shown that OSA syndrome was the main risk factor for cardiovascular morbidity and mortality
      (RR = 9.1 [95%, 2.6 to 31.2]).

      If the value of treatment with Continuous Positive Airway Pressure (CPAP) in symptomatic CAD
      patients (daytime sleepiness and/or 2 clinical symptoms with Apnea Hypopnea Index (AHI) ≥ 20)
      appears to be established, treatment with CPAP in asymptomatic CAD patients (with AHI> 30)
      may be too demanding. Alternative treatments are rare and results are highly variable.
      Therefore, it would be interesting to suggest other treatment modalities with moderate
      coronary and/or minimally symptomatic OSA syndrome.
    

Detailed description: 
      This study aims to assess the relevance of inspiratory muscles strengthening on reducing AHI
      in CAD patients with moderate OSA (AHI between 15 and 30).
    

Intervention name(s): POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening]; Control
Intervention type(s): Device; Other
Intervention description(s): CAD patients participated in a 6-week (20 sessions of training) resistive inspiratory muscle training (RIMT) program for 10 minutes twice daily at a training intensity of 70% of maximum inspiratory pressure (MIP).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; Resistive inspiratory muscle training; Coronary artery disease; Cardiac rehabilitation
Leflunomide for Maintenance of Remission in IgG4 Related Disease
Condition: Immunoglobulin G4 Related Sclerosing Disease
MeSH terms: Immunoglobulin G4-Related Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The study has been designed as a 12-month, open-label, randomized, controlled study comparing
      the use of prednisone mono-therapy and prednisone and leflunomide combination therapy in
      treating patients with IgG4-related disease.
    

Detailed description: 
      The aim of this clinical trial is to determine the safety and efficacy of Leflunomide in
      treating patients with IgG4-related disease by comparing the outcomes of prednisone and
      leflunomide combination therapy with prednisone mono-therapy. The follow-up period will be 12
      months. During the follow-up period, results of laboratory tests and image examinations,
      IgG4-RD RI and other parameters which can reflect treatment response as well as adverse
      effect events will be recorded.
    

Intervention name(s): Prednisone; Leflunomide
Intervention type(s): Drug; Drug
Intervention description(s): Prednisone:A starting dose of 0. 5-0. 8mg/(kg*d) will be given. Following four-week period, the dose will be tapered gradually to 5mg/d until the end of 12 months of follow-up period.; Leflunomide:A starting dose of 20 mg/day will be given. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor adverse effects occur(e.g., liver enzyme elevations).
Other intervention name(s): Prednisolone; ARAVA®
Intervention MeSH terms: Prednisone; Prednisolone; Leflunomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IgG4-related disease; IgG4-related sclerosing cholangitis; Mikulicz disease; Pancreatitis; Retroperitoneal fibrosis; Lymphadenopathy
Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in affluent
      countries. It may progress to cirrhosis and liver cancer. At present, there is no approved
      drug for NAFLD. Although healthy diet and exercise is often recommended, there is little
      supportive evidence. Therefore, the investigators plan to conduct a randomized controlled
      trial comparing a low glycemic index dietary intervention program and simple lifestyle advice
      in NAFLD patients. The primary endpoint is resolution of NAFLD. Non-invasive tests will be
      used to assess the study subjects. Proton-magnetic resonance spectroscopy is used to quantify
      hepatic triglyceride content, and transient elastography is used to quantify liver fibrosis.
    


Intervention name(s): Low glycemic index dietary intervention program; simple lifestyle advice
Intervention type(s): Other; Other
Intervention description(s): The intervention group involves dietary advice and monitoring. No drug or invasive procedure is involved.; The control group receives lifestyle advice from a clinician, and the clinical care is not inferior to current practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Effect of the Extract of the Flour Fermented With Bacillus Subtilis Var Natto DC-15 on Postprandial Glucose
Condition: Prediabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The purpose of the present study is to evaluate the effect of the extract of the flour
      fermented with Bacillus subtilis var natto DC-15 on postprandial glucose level in subjects
      with prediabetes.
    


Intervention name(s): Placebo; Bacillus subtilis var natto DC-15
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Clinical and Biochemical Evaluation of 1% Metformin in Non-surgical Treatment of Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      The aim of the study to evaluate the clinical and biochemical efficacy of 1% Metformin gel in
      treatment of periodontitis patients
    


Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Locally delivered Metformin gel in the treatment of periodontitis patients; Placebo gel consist of drug without the active component.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Evaluate the clinical parameters ( Probing Depth, Clinical Attachment Level, Gingival and Plaque Indices) before & after the application of locally delivered metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Efficacy of Double Dose Oral Terbinafine Vs Itraconazole in Treatment of Dermatophyte Infections of Skin.
Condition: Dermatophyte Infection; Terbinafine Adverse Reaction; Itraconazole Adverse Reaction
MeSH terms: Infections; Communicable Diseases; Dermatomycoses
Study type: Interventional
Phase: Phase 3

Summary: 
      Study would be conducted to compare the efficacy and safety of double than usual dose oral
      terbinafine versus itraconazole in treatment of dermatophyte infections of skin in patient
      presenting at dermatology department of Pak Emirates Military Hospital, Rawalpindi, Pakistan.
    

Detailed description: 
      -  Study would be a randomized controlled trial, in which 120 subjects would be randomly
           divided into two equal groups of 60 each.

        -  Each group would be prescribed double than usual dose of terbinafine(250 mg twice daily)
           or itraconazole(100mg twice daily) for 2 weeks initially. Treatment may be extended to 4
           weeks if cure has not been achieved.

      Patients will be diagnosed and followed on the basis of classical clinical features of
      dermatophyte infections and microscopic potassium hydro-oxide slide preparation for fungal
      hyphae and spores.

      Liver function tests will be checked on day 0, 14 and 28. Individuals aged 15-50 years with
      one or no co-morbidity will be included in the study.

      Study will be conducted over a period of 6-8 months.
    

Intervention name(s): Terbinafine Pill; Itraconazole capsule
Intervention type(s): Drug; Drug
Intervention description(s): Double than usual dose of oral terbinafine pills will be used for treatment purpose in one group.; Double than usual dose of oral itraconazole capsules will be used for treatment purpose in second group.
Other intervention name(s): Lamisil; Icon
Intervention MeSH terms: Itraconazole; Terbinafine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: double dose; oral terbinafine; oral itraconazole; dermatophyte skin infection; randomized controlled trial
Relationship Between Sensory and Motor Systems in Restless Leg Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Observational

Summary: 
      This study will explore what occurs between sensory and motor systems in restless legs
      syndrome (RLS). Patients with RLS have uncomfortable sensations in the legs, usually in the
      evening or early part of the night. Most patients also have periodic involuntary leg
      movements. The condition tends to worsen over time, resulting in severe discomfort and sleep
      disturbances.

      Healthy normal volunteers and patients with RLS between 18 and 80 years of age may be
      eligible for this study. All candidates will be screened with a medical history, physical and
      neurological evaluations, electroymogram (measure of muscle activity), overnight sleep study,
      electrocardiogram (ECG, measurement of the electrical activity of the heart), and blood and
      urine tests. They may also have brain or spine magnetic resonance imaging (MRI) or
      computerized tomography (CT) scans and a chest X-ray. Participants must stop taking all
      medications prohibited by the study for 2 days or more before the study starts and throughout
      its duration.

      Participants will undergo prepulse inhibition tests to assess nervous system function. The
      participant sits comfortably in a quiet room. Several cables are attached to the face and
      legs using a special cream that conducts electrical signals through the cables to recording
      equipment. Nervous system activity is evaluated while the subject is at rest and after
      sensory stimulation (stimulating the nerves in the legs and face with a very brief electrical
      current of mild to moderate intensity). At times, the subject receives a short, mild sound
      stimulation delivered through earphones. The testing session takes 4 to 6 hours.
    

Detailed description: 
      Background - Restless leg syndrome (RLS), a condition affecting millions of Americans, is
      characterized by uncomfortable sensory symptoms relived by voluntary or involuntary
      movements. Objectives -To test our hypothesis that sensorimotor gating is deficient in RLS.
      Methods - In a controlled proof-of-principle clinical study, sensorimotor gating will be
      assessed through the use of validated electrophysiological tests of prepulse inhibition, in
      17 adult patients with RLS and 17 matched healthy controls. Risks and benefits -Risks
      involved in this study are minimal, and deemed reasonable in relation to potential benefits.
      This investigation will lead to a better understanding of the pathophysiology of RLS.
    

Keywords: Prepulse Inhibition; PPI; Dopamine; Sensorimotor Integration; Dopaminergic
Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multi-center, open-label, single-arm trial to evaluate the efficacy,safety
      and pharmacokinetics of SCT800 in regular prophylaxis and perioperative treatment in patients
      (≥12 years old) with severe hemophilia A who have been previously treated with coagulation
      factor VIII(FVIII:C) . This study includes two phases: the screening period and prophylaxis
      period.Prophylaxis with 25 - 50 IU/kg of SCT800 shall be administered once every other day or
      three times per week starting from V1 and prophylaxis with SCT800 shall continue for 24
      consecutive weeks.
    

Detailed description: 
      After subjects pass screening, prophylaxis with 25 - 50 IU/kg of SCT800 shall be administered
      once every other day or three times per week for 6 months. Subjects shall receive FVIII
      intravenous injection treatment at the study site or at home. During the study prophylaxis
      treatment period, subjects should return for visit every four weeks, namely for Visit (V) 2
      (4 weeks ± 4 days), Visit 3 (8 weeks ± 4 days), Visit 4 (12 weeks ± 4 days), Visit 5 (16
      weeks ± 7 days), Visit 6 (20 weeks ± 7 days), Visit 7 (24 weeks ± 7 days) and
      end-of-treatment (EOT) visit (+ 14 days). Of which, blood collection shall be carried out
      during the screening period and in V1, V2, V4, V7 and the EOT visit for FVIII inhibitor
      assay; blood collection shall be carried out before and after the completion of SCT800
      infusion in V1, V4 and V7 for incremental in-vivo recovery (IVR) assay.

      FVIII:C activity shall be monitored before injection and 15minutes(min), 30min, 1h, 3h, 6h,
      9h, 12h, 24hours(h), 28h, 32h and 48h after injection at V1 and V7. Then pharmacokinetics
      parameters (incremental in-vivo recovery, t1/2 etc.) of SCT800 shall be calculated and
      evaluated.

      5 subjects may receive elective surgical treatment within the prophylaxis treatment period
      (after the first drug administration in day 0).
    

Intervention name(s): Recombinant Human Coagulation FVIII
Intervention type(s): Drug
Intervention description(s): Participant received SCT800 for prophylaxis with 25 - 50 IU/kg injection once every other day or three times per week for 6 months.
Other intervention name(s): SCT800
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention