bioihbjkbjnl/mcl2 huggingface dataset:
Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat
Condition: Pharyngitis
MeSH terms: Pharyngitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg
      in the treatment of sore throat in patients with acute viral pharyngitis.
    

Detailed description: 
      Male and female ambulant patients complaining of a sore throat caused by acute viral
      pharyngitis. Every patient may be included in the trial only once. A total of 250 male and
      female ambulant patients between the ages of 18 and 65 years will be enrolled. Approximately
      8 centers will be recruited each enrolling approximately 30-32 patients.

      Study Hypothesis:

      The two-sided test hypothesis, that the results of the active treatment group with 20 mg
      Ambroxol and the placebo group do not differ with regard to the primary endpoint (null
      hypothesis (H0) will be tested against the alternative (H1) that they are not equal.

      Comparison(s):

      PRIMARY ENDPOINT:

      Indication of pain on the VRS (PI)-verbal rating scale (pain intensity)-in the first 3 hours
      (the patient rates his/her pain on a six-point verbal rating scale).

      SECONDARY ENDPOINT (S):

        1. Patient's assessment of effectiveness and tolerance. The patient assesses the
           effectiveness and the tolerance of the test medicine for treating his sore throat at the
           end of the first and second day of treatment, by means of a verbal rating scale.

        2. Participating doctors assessment of tolerance.
    

Intervention name(s): Ambroxol; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ambroxol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Comparative, Pharmacokinetic Study of CB-839 Capsule and Tablet Formulations in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, single-dose, 2-way crossover PK comparability study of CB-839
      administered as capsule and tablet formulations in healthy adult subjects.
    

Detailed description: 
      A new tablet formulation of CB-839 was recently developed in order to enable rapid, automated
      manufacturing of CB-839. Previous studies have used a capsule formulation of CB-839. This
      study will enable a PK comparison between CB-839 capsules and CB-839 tablets.

      This is a Phase 1, comparative, randomized, single-dose, 2-way crossover PK comparability
      study of CB-839 administered as capsule and tablet formulations in healthy adult subjects.
      Serial blood samples for PK analyses will be collected over a 24 hour period after each
      administration of CB-839. All subjects will be monitored for safety throughout their
      participation in the study.
    

Intervention name(s): CB-839 Capsules; CB-839 Tablets
Intervention type(s): Drug; Drug
Intervention description(s): 3 x 200 mg CB-839 Capsules (Reference Formulation); 3 x 200 mg CB-839 Tablets (Test Formulation)
Other intervention name(s): Glutaminase inhibitor; Glutaminase inhibitor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glutaminase Inhibitor; Glutaminase; CB-839
A Study With RO4917523 in Patients With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, double-blind multiple ascending dose study will evaluate the safety and
      tolerability, pharmacokinetics and efficacy of RO4917523 in patients with Fragile X Syndrome.
      The patients will be randomized to receive either active drug or placebo. The anticipated
      time on study treatment is 6 weeks. The target sample size is <100 patients.
    


Intervention name(s): Placebo (for RO4917523 ascending doses); Placebo (for RO4917523 fixed dose); RO4917523; RO4917523
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo daily po; Placebo daily po; RO4917523 ascending doses daily po; RO4917523 fixed dose daily po
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Open Trial Combining Zidovudine, Interferon-alfa, and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      To restore immunologic function and virus-free state in HIV-infected patients. Based on
      previous studies showing temporary improvement in immune function in HIV-infected patients
      using peripheral lymphocyte transfers and bone marrow transplantation, and based on studies
      documenting the antiretroviral effects of zidovudine (AZT) and interferon-alfa (IFN-A) as
      well as the preliminary test tube and patient studies suggesting anti-HIV effects of
      recombinant CD4-IgG, we propose to treat HIV-infected patients using combination
      antiretroviral therapy with transplantation of bone marrow and peripheral lymphocytes from
      previously immunized donors in an attempt to restore immunologic function and a virus-free
      state.
    

Detailed description: 
      Based on previous studies showing temporary improvement in immune function in HIV-infected
      patients using peripheral lymphocyte transfers and bone marrow transplantation, and based on
      studies documenting the antiretroviral effects of zidovudine (AZT) and interferon-alfa
      (IFN-A) as well as the preliminary test tube and patient studies suggesting anti-HIV effects
      of recombinant CD4-IgG, we propose to treat HIV-infected patients using combination
      antiretroviral therapy with transplantation of bone marrow and peripheral lymphocytes from
      previously immunized donors in an attempt to restore immunologic function and a virus-free
      state.

      Three patients are treated with stable doses of AZT, IFN-A, and CD4-IgG for 12 weeks,
      followed by six peripheral lymphocyte infusions and transplantation of bone marrow from their
      respective identical twins. Following bone marrow transplantation, patients continue to
      receive the three drugs. Additional periods of lymphocyte apheresis and transfer may be
      offered to each donor/recipient pair.
    

Intervention name(s): CD4-IgG; Zidovudine; Interferon alfa-n1; Peripheral lymphocyte infusion; Bone marrow transplant
Intervention type(s): Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Interferons; Interferon-alpha; Zidovudine; CD4 Immunoadhesins
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recombinant Proteins; IgG; Drug Evaluation; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; Antigens, CD4; Zidovudine; Carrier Proteins; Interferon Type I
Synchronized Cardiac Assist for Cardiogenic Shock
Condition: Shock, Cardiogenic; High Risk Percutaneous Coronary Interventions
MeSH terms: Shock, Cardiogenic; Shock
Study type: Observational

Summary: 
      The purpose of this study is to collect prospective safety and performance information for
      the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung
      failure or in high risk percutaneous intervention procedures in catheterization lab.
    


Intervention name(s): i-cor Synchronized Cardiac Assist Device
Intervention type(s): Device
Intervention description(s): The i-cor Synchronized Cardiac Assist Device delivers pulsatile cardiac assist synchronized to the ECG during diastole and provides enhanced oxygenation through a membrane oxygenator.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with cardiogenic shock or in high risk percutaneous intervention procedures in the
        cardiac catheterization lab
Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite (HDM) Tablets in Allergic Rhinitis Environment Exposure Chamber Model
Condition: House Dust Mites Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite
      (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score
      during the allergen chamber challenge before and after 6 months of treatment.
    


Intervention name(s): 100IR; 300IR; 500IR; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): 100IR sublingual tablet of; 300IR sublingual tablets of; 500IR sublingual tablet of; Placebo sublingual tablet of
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HDM; allergic rhinitis
Study to Evaluate the Effect and Safety of Quetiapine Extended Release (XR) (FK949E) in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, quetiapine XR or placebo will be administered orally for 6 weeks to major
      depressive disorder patients with lack of response to existing antidepressants, with the aim
      of evaluating the efficacy of quetiapine XR and dose-response in three quetiapine XR dose
      groups based on changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores.
    


Intervention name(s): quetiapine extended release (XR); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Extended release tablets; matching tablets
Other intervention name(s): Seroquel XR; FK949E
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: patients; FK949E
Effect of TU-100 on Gastrointestinal and Colonic Transit in Humans
Condition: Postoperative Ileus
MeSH terms: Ileus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare the dose related effects of orally administered
      TU-100, a botanical agent that modulates gastrointestinal nerves, on gastrointestinal
      motility and colonic transit of solids.
    


Intervention name(s): Daikenchuto (TU-100); Daikenchuto (TU-100); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive 2.5g TID (7.5g/day) of TU-100. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.; Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.; Subjects will receive daily dose of TU-100 placebo. Dosage form is a granule. Subject will take a daily dose divided three times a day for 5 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Gastric emptying; Small bowel transit; Colonic transit; Whole gut transit; Postoperative Ileus
Hexetidine and Chlorobutanol for Lesions Due to Prostheses
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives: The study aimed at assessing the efficacy of a new mouthwash in treating oral
      lesions due to removable prostheses.

      Methods: The present prospective randomized clinical trial was performed on 44 patients. The
      experimentation lasted for 4 weeks and 4 operators participated. The effects of the mouthwash
      were evaluated subjectively and objectively, with questionnaires, Visual Analogic Scales and
      clinical examinations. The results were statistically analyzed. The following variables were
      recorded: presence of mucosal lesions due to incongruous removable prostheses and lasting of
      pain after rinsing.
    

Detailed description: 
      The aim of the present prospective, randomized, triple-blind controlled clinical trial was to
      evaluate the efficacy of an innovative mouthwash (emulsion) in the treatment of lesions of
      oral mucosae due to removable prostheses. The tested preparation contained two active
      molecules: a topical antiseptic (0.1% hexetidine) and a local anesthetic (0.5%
      chlorobutanol).
    

Intervention name(s): chlorobutanol, hexetidine; Chlorhexidine
Intervention type(s): Drug; Drug
Intervention description(s): 3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash; 3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
Other intervention name(s): Curasept® ADS 0.20%, Curaden Healthcare; Curasept® ADS 0.20%, Curaden Healthcare
Intervention MeSH terms: Chlorhexidine; Hexetidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Clinical Study to Evaluate the Efficacy of VR506 Using a New Inhaler for the Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to evaluate the clinical efficacy of three doses of VR506
      delivered via a new dry powder inhaler for the treatment of asthma.
    


Intervention name(s): VR506; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): VR506 inhalation powder delivered via a new dry powder inhaler; Placebo delivered via a new dry powder inhaler
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam
      formulation.
    

Detailed description: 
      This is the standard patch test over 21 days of exposure of the test product,its vehicle and
      a positive as well as a negative control.
    

Intervention name(s): azelaic acid pre-foam formulation; Vehicle pre-foam formulation; Water; Sodium lauryl sulfate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Azelaic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: dermal irritative potential
Evaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment
Condition: Acute Pulpitis
MeSH terms: Pulpitis; Pain, Postoperative
Study type: Interventional

Summary: 
      A study to comparatively evaluate the post operative pain between root canal preparation by
      reciprocating file (TF) and full rotation file (M-Pro) in patients with single rooted teeth
      with acute irreversible pulpits.
    

Detailed description: 
      Teeth with symptomatic irreversible pulpitis are selected according to the eligibility and
      exclusion criteria and patients are then randomized to receive treatment after using Twisted
      files or M-pro files. The treatment is done in single visit. The postoperative pain is then
      assessed using the Numerical Rating Scale 6,12, 24 and 48 hours post-instrumentation.
    

Intervention name(s): Twisted file; Mpro
Intervention type(s): Device; Device
Intervention description(s): Use of twisted file during cleaning and shaping of root canals; Use of Mpro during cleaning and shaping of root canals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of NGR-hTNF as Single Agent in Patients Affected by Colorectal Cancer (CRC)
Condition: Colorectal Cancer (CRC)
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of the trial is to document the progression free survival (PFS) in
      advanced or metastatic colorectal cancer patients treated with NGR-hTNF as single agent.
      Safety will be established by clinical and laboratory assessment according to NCI-CTC
      criteria.
    

Detailed description: 
      This is a phase II, open-label, non-randomized study that will be conducted in patients
      affected by advanced or metastatic colorectal cancer (CRC), previously treated with
      fluoropyrimidine, oxaliplatin and irinotecan based regimens, that will be conducted using
      Simon's two-stage design method.
    

Intervention name(s): NGR-hTNF
Intervention type(s): Drug
Intervention description(s): iv q3W or q1W NGR-hTNF 0.8 μg/m²
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NGR-hTNF; CRC
Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women
Condition: Fractures, Bone; Bone Marrow Disease; Fat Disorder; Adiposity
MeSH terms: Bone Marrow Diseases; Obesity; Fractures, Bone
Study type: Observational

Summary: 
      The purpose is to determine in a case-control study if an association exist between bone
      marrow adiposity and fragility fractures in post-menopausal women.
    


Intervention name(s): Dixon Magnetic Resonance Imaging; dual-energy X-ray absorptiometry (DXA)
Intervention type(s): Device; Device
Intervention description(s): MRI of the lumbar spine (L1 to L4) and hip (non-dominant) for the measurement of Ad Med. (In%) by the DIXON sequence.; Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Post-menopausal women
      
Keywords: marrow adipose tissue; bone marrow adiposity
Lactobacillus Rhamnosus and PCOS Treatment
Condition: Insulin Resistance; Polycystic Ovary Syndrome; Hyperandrogenism; Obesity
MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      The effect of Lactobacillus rhamnosus supplementation on body weight, hyperandrogenism and
      insulin resistance in overweight and obesity women with Polycystic Ovary Syndrome will be
      analysed.
    


Intervention name(s): Lactobacillus group; Dietary group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Nutrition intervention focused on the treatment of insulin resistance + Lactobacillus rhamnosus supplementation (6x10 9 of lactobacillus rhamnosus x 2 times a day) (35 people).; Nutritional intervention focused on the treatment of insulin resistance (35 subjects).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Lactobacillus rhamnosus; Polycystic Ovary Syndrome; insulin resistance; nutrition intervention; probiotic
Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex Syringe
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Determine patient satisfaction with the single-use autoinjector for the delivery of
      pre-filled Avonex syringe.
    


Intervention name(s): Interferon beta-1a; Single-use autoinjector
Intervention type(s): Drug; Device
Intervention description(s): 30mcg, IM once-a-week; Single-use autoinjector with Avonex 30mcg pre-filled syringe
Other intervention name(s): Avonex
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Multiple Sclerosis; interferon beta-1a; Avonex; liquid Avonex
Cognitive Behavioral Therapy for Adolescents With Bulimia
Condition: Bulimia Nervosa
MeSH terms: Bulimia; Bulimia Nervosa
Study type: Interventional

Summary: 
      This pilot study will evaluate the effectiveness of individual cognitive behavioral therapy
      (CBT) and supportive psychotherapy (SP) in reducing bulimic symptoms among adolescents.
    

Detailed description: 
      Patients will be randomized to have an equal chance of either receiving CBT or SP.
      Participants will include both individuals with DSM-IV bulimia nervosa (BN), and patients
      with sub-threshold BN. Adolescent patients will be treated at the New York State Psychiatric
      Institute, with a target recruitment of 20 patients completing the study. Participants in
      both conditions will be assessed prior to treatment and at the end of treatment. This trial
      is intended to serve as a pilot investigation to determine the feasibility and utility of a
      larger controlled study in this population.
    

Intervention name(s): cognitive behavior therapy; Supportive Psychotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The cognitive behavioral therapy used in this study will focus on developing patterns of regular eating, addressing body image issues, and ways to cope with situations that trigger eating disordered behaviors.; The supportive psychotherapy treatment used in this study will involve identifying issues underlying your child's eating disorder and giving your child information about the psychological processes that tend to maintain or continue eating disorder symptoms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BN and subthreshold BN