bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the combination of aerobic physical
      exercise and alprazolam in patients with panic disorder has a better therapeutic response
      than the treatment with alprazolam alone.
    

Detailed description: 
      We have observed in our clinical practice that patients who practiced aerobic physical
      exercise had faster remissions and better improvement in their treatments that those who did
      not. There are also some scientific studies that included physical exercise in the treatment
      for panic disorder and compared them to other single pharmacological treatments.

      So our objective will be to compare the efficacy of a pharmacological monotherapy
      (alprazolam), that is one of the options for the pharmacological treatment of panic disorder,
      with other treatment such as the combination of aerobic physical exercise and alprazolam, and
      to determine if this combination results in a better therapeutic response.
    

Intervention name(s): Alprazolam; Alprazolam + Aerobic exercise
Intervention type(s): Drug; Drug
Intervention description(s): The patients assigned to the pharmacological plan will receive 4 mg alprazolam daily for 12 weeks. Two weeks after the first interview they have their first baseline psychiatric control, where all the patients are tested.
Then, at the same visit, all the patients are indicated 4 mg of alprazolam. The dose is gradually increased from 1 to 4 mg along the first week of treatment. The test is repeated during weeks 2, 4, 8 and 12.; The patients assigned to exercise have to pass an ergometric test to determine their functional capacity expressed in METs for future exercise indication.
Two weeks after the first interview they have their first baseline psychiatric control and at the same time they are indicated a 4 mg dose of alprazolam, gradually increased from 1 to 4 mg along the first week of treatment. The test is repeated during weeks 2, 4, 8 and 12.
Then they follow a protocolized aerobic exercise plan for this study during 12 weeks.
The type of selected exercise consists of a rapid walk for 30 minutes divided in stages.
After each stage the patient has to control his own heart frequency that has to be between 50 and 75% of their maximum to assure an aerobic condition (American Cardiological Association).
Other intervention name(s): Non exercise group; Exercise group
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Panic disorder; Exercise; Alprazolam; Aerobic
The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      IBS is a disorder of movement in the gut. People who have IBS may have diarrhea,
      constipation, or alternating bouts of both. IBS is not caused by injury or illness. Often the
      only way doctors can diagnose it is to rule out other conditions through testing.
    

Detailed description: 
      Probiotics, particularly Bifidobacterium infantis, Sacchromyces boulardii, Lactobacillus
      plantarum and combination probiotics may help regulate how often people with IBS have bowel
      movements. Probiotics may also help relieve bloating from gas. Research is continuing to
      determine which probiotics are best to treat IBS.

      PX0612

      PX0612 is a probiotic which is composed of the following ingredients contained in a veggie
      capsule, being one dose:

      Bacillus coagulans 200 million colony forming units 16.0mg Bacillus subtilis 100 million
      colony forming units 4.8mg Enterococcus faecium 100 million colony forming units 0.6mg
      Fructo-oligosacharride a nutrient for the packaged product 600.0mg Total 621.4 mg Bacillus
      coagulans is a non-pathogenic, Gram positive, spore forming bacteria that produces lactic
      acid. Though not normally found in the gut. Bacillus coagulans strains have been used as
      general nutritional supplements and agents to control constipation and diarrhea in humans and
      animals.
    

Intervention name(s): PX0612; Di-Calcium Phosphate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): PX0612 is a probiotic contained in a veggie capsule.; Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: IBS-D; diarrhea predominant
Efficacy of Computer-assisted Cognitive Remediation in Patients With Schizophrenia
Condition: Schizophrenia; Psychosis; Cognitive Impairment; Executive Function; Randomized Controlled Trial; Efficacy
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Objective: To determine the efficacy of computer-assisted cognitive remediation (CACR) in
      patients with chronic schizophrenia in the community settings.

      Study Design: Single-blinded prospective, pre-test/post-test randomized controlled trial
      (RCT) will be conducted in 2 groups of participants that receiving training in community
      settings. Treatment groups will attend individualized CACR programme using CogniPlus® while
      control group will continue attend conventional treatment as usual (TAU). Assessment on the
      means difference in assessing functions will be done after the study.

      Samples: 80 patients with stable and chronic schizophrenia will be recruited from the
      community, using a sampling frame of selected diagnosis and homogeneity.

      Expected Findings: Find out the training effects of selected CACR on EF and daily functioning
      in patients with schizophrenia.
    

Detailed description: 
      Schizophrenia is one of the most serious and disabling mental disorders. Prevalence of
      schizophrenia is about 1% worldwide. The related dysfunctions have great impact and burden to
      the concerned person and to the society. With increasing use of CR programmes in helping the
      patients to resume their capability in community living, the clinical outcome was not fully
      established especially on specific cognitive domains such as executive function (EF). The
      present study aims at evaluating the efficacy of CACR on developing EF and improving daily
      functioning. The result will provide information for therapists' future clinical decisions
      for patients' best reintegration into the societies. This also helps decrease the burden of
      family, society in the long run.
    

Intervention name(s): Computer-assisted Cognitive Remediation; Conventional training programmes
Intervention type(s): Other; Other
Intervention description(s): Drill practice and bridging activities; Existing conventional activities in the settings
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized Controlled Trial; Computer-assisted Cognitive Remediation; Executive Function
Dose Ranging Study of OTO-201 in AOMT
Condition: Acute Otitis Media; AOMT
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 2

Summary: 
      Dose Ranging Study of OTO-201 in AOMT
    

Detailed description: 
      This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled,
      blinded study in which eligible subjects with either unilateral or bilateral acute otitis
      media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12
      mg OTO-201, or sham into the affected ear(s).
    

Intervention name(s): 6 mg ciprofloxacin; 12 mg ciprofloxacin; Sham
Intervention type(s): Drug; Drug; Other
Intervention description(s): Single administration of OTO-201; Single administration of OTO-201
Other intervention name(s): OTIPRIO; OTIPRIO
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Acute otitis media with tympanostomy tubes; OTIPRIO
Pain Inhibition and Facilitation in Recurrent Low Back Pain
Condition: Recurrent Low Back Pain; Healthy
MeSH terms: Recurrence; Back Pain; Low Back Pain
Study type: Observational

Summary: 
      This study evaluates psychophysical measures of pain inhibition and facilitation, along with
      cortical responses to different sensory stimuli, in patients with recurrent low back pain and
      matched healthy individuals.
    

Detailed description: 
      Pain inhibitory and facilitatory mechanisms have been suggested to play a role in the
      development of persistent low back pain; however, there is still debate on when changes in
      these mechanisms occur. Similarly, evoked cortical responses can reflect neuroplastic changes
      in pain processing regions, which are also thought to play a role in the transition to
      persistent pain, but there is also debate on when these neuroplastic changes develop relative
      to low back pain. Therefore, this study will use patients with an intermediary clinical pain
      state, recurrent low back pain, and matched healthy control participants, to investigate
      within and between subject differences in pain inhibitory, facilitatory and neuroplastic
      mechanisms.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population recruited from university, college, and wider Aalborg community
Dendritic Cell Vaccination in Patients With Advanced Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Dendritic cells loaded with tumor antigens induce cytotoxic T-cells which have been proved
      capable of killing both melanoma and breast cancer cells. Melanoma and colorectal cancer
      cells express some common antigens. Hence it is possible to use melanoma lysate to load the
      dendritic cells with tumor antigens similar to the antigens expressed by the patients'
      colorectal cancer cells.

      The patient receives 10 vaccinations with 14 days between each. The parameters for effect are
      changes in tumor/metastasis size measured with computed tomography (CT), decrease in serum
      concentration of carcinoembryonic antigen (CEA), performance status measured by the World
      Health Organization (WHO) criteria, and Quality of Life.
    


Intervention name(s): MelCancerVac
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: dendritic cells; antigens, neoplasm
Factors Influencing the Abortion Interval of Second-trimester Termination of Pregnancy Using Misoprostol
Condition: Labor Induction
Study type: Observational

Summary: 
      This study aims to analyze the factors influencing the abortion interval of second-trimester
      termination of pregnancy using misoprostol.
    

Detailed description: 
      Misoprostol is the primary drug of choice for medical termination. It is not only cheap, but
      also stable at room temperature and easily available worldwide. It is indicated for the
      treatment of gastritis, but is widely used off-label for a variety of indications in the
      practice of obstetrics and gynecology, including medication abortion, induction of labor, and
      the treatment of postpartum hemorrhage. The optimal dosage and route of administration have
      not been well defined and vary with physicians. The potency of misoprostol's effect varies
      with dosage, route of administration and dosing interval; both maternal and fetal factors
      may, to certain extent, affect the abortion interval. This study aims to analyze the factors
      influencing the abortion interval of second-trimester termination of pregnancy using
      misoprostol.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This is a single-center, retrospective chart review study. All female patients who were
        admitted for medical termination of second-trimester pregnancy from January 2008 to May
        2013, at the Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital were
        recruited.
      
Keywords: termination of pregnancy, abortion
Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
Condition: Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Acute Myelogenous Leukemia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Myelodysplastic Syndrome
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Hodgkin Disease; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to evaluate a CMV vaccine given to related donor/recipient pairs
      (donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just
      before and after transplantation) and CMV-seropositive recipient-only subjects (related or
      unrelated) to determine incidence rates of CMV infection, disease, and other complications
      from immunosuppression and/or transplantation. The outcomes for the groups receiving CMV
      vaccine will be compared to the outcomes for the group that received the placebo vaccine to
      see if there is a clinical benefit. For this trial, donors and recipients must have matched
      HLA genotype (matched at 5/6 or 6/6 HLA loci).
    

Detailed description: 
      This study was run by Vical and the record was transferred to Astellas on 1/8/2013.

      Trial will enroll up to 240 subjects (160 recipients and 80 donors). Qualified donors and/or
      CMV-seropositive recipients (donor/recipient pairs or recipient-only subjects) will be
      assigned randomly to receive either a CMV vaccine or a placebo vaccine. Donors will receive 3
      vaccines prior to donation and recipients will receive 1 vaccine pretransplant and up to
      three vaccines posttransplant. Recipients will be followed for up to 1 year after transplant
      to evaluate the safety of the vaccine and to see if there is a clinical benefit in the group
      that received the CMV vaccine. The incidence rates of CMV infection, disease, and other
      complications from immunosuppression and/or transplantation will be studied.
    

Intervention name(s): VCL-CB01; Phosphate-buffered Saline (PBS)
Intervention type(s): Biological; Other
Intervention description(s): 5 mg/mL, Intramuscular (IM.) 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients; 1 mL, IM. 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cytomegalovirus infection; infectious disease; viremia; cytomegalovirus disease; stem cell transplant; allogeneic; bone marrow transplant; hematopoietic cell transplant; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Acute Myelogenous Leukemia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Myelodysplastic Syndrome
A Phase 1, Randomized, Double-blind, Placebo-controlled Crossover Study of RG7314 on the Potential Regulation of Higher Brain Functions in Healthy Male Participants: Proof of Mechanism
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single site, randomized, double-blind, three period cross-over, placebo-controlled,
      proof of mechanism study in healthy male subjects. The study will investigate whether the
      directionality of brain activity and connectivity in response to intranasal vasopressin
      treatment is similar to earlier studies and explores the effect of short-term treatment with
      RG7314 on functional MRI as a pharmacodynamic marker. While in the scanner, the participants
      will be asked to perform a face matching task and a Theory of Mind task, among other
      assessments. Participants' exposure to study drug will be assessed and all participants will
      receive follow-up examination 1 and 4 weeks after last dose.
    


Intervention name(s): Placebo RD + AVP SD; Placebo RD + Placebo SD; RG7314 RD + AVP SD
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo (matching to study drug) repeat doses + intranasal AVP single dose; Placebo (matching to study drug) repeat doses + intranasal Placebo (matching to intranasal AVP) single dose; RG7314 repeat doses + intranasal AVP single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure
Condition: Prehypertension; Gout; Pulse Wave Velocity; Hypertension; 24 Hour Blood Pressure
MeSH terms: Hypertension; Prehypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      High normal blood pressure, also called prehypertension, is a significant problem. High uric
      acid in the blood, the same thing that causes gout, may cause higher blood pressures. The
      investigators plan to monitor the effects of the drug febuxostat(trade name Uloric) on blood
      pressure and stiffness of the main blood vessels and see if lowering uric acid has any
      effect.
    


Intervention name(s): Febuxostat
Intervention type(s): Drug
Intervention description(s): 80mg PO daily for 8 weeks
Other intervention name(s): Uloric
Intervention MeSH terms: Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Prehypertension; Gout; Puls Wave Velocity; Hypertension; 24 hour blood pressure
A Study of Duloxetine in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the effectiveness and safety of duloxetine in
      participants with fibromyalgia.
    


Intervention name(s): Duloxetine 60 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Duloxetine 60 mg taken orally once every day for 15 weeks; Placebo taken orally once every day for 15 weeks
Other intervention name(s): LY248686; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
BIOmarkers in Severe AsthMa Patients on Omalizumab Treatment
Condition: Severe Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Eosinophil infiltration and degranulation in airways has been implicated in the pathology of
      asthma. Periostin is considered to be a marker of eosinophilic inflammation and is one of the
      highly expressed genes in epithelial cells and lung fibroblasts in asthma. Omalizumab is
      approved as add-on therapy in the treatment of severe allergic asthma. The aim of the study
      is to assess inflammatory biomarkers including: blood and sputum eosinophilia, periostin and
      IL-6 as long-term clinical outcomes of omalizumab therapy.
    

Detailed description: 
      Anti-IgE (omalizumab) has been shown to be an effective add-on therapy for patients with
      allergic severe asthma. In this observational study patients aged over 18 year with
      uncontrolled severe persistent asthma are selected for add-on therapy with omalizumab.
      Patients were on high dose of ICS and had a documented history of 2-6 exacerbations requiring
      treatment with systemic corticosteroids ( with >15 mg/day prednisone or other medications at
      similar dose, for at least 3 days). The individual dose and frequency of omalizumab
      administration is assessed from the dosing table. Lung function tests and asthma
      questionnaires (ACQ, AQLQ and RQLQ) are used in the aim of assessing clinical improvement
      after omalizumab treatment. Induced sputum (IS) and exhaled breath condensate (EBC) are used
      as a simple non-invasive methods for monitoring cellular and biochemical changes in the
      airways. Total blood eosinophil count, IS cytology, IS and EBC periostin and IL-6
      concentrations are measured. Analyses are performed at entry and after 16, 52 and 104,156
      weeks of omalizumab treatment.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Severe allergic asthma
      
Keywords: severe asthma; anti-IgE; periostin; induced sputum,; exhaled breath condensate
Study of Dapagliflozin on Mitochondrial Dysfunction and Impaired Insulin Signaling/Action
Condition: Insulin Sensitivity; Multiple Mitochondrial Dysfunctions Syndrome
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of the chronic treatment of type 2
      diabetes (T2DM) with dapagliflozin on: (1) mitochondrial gene function/expression and insulin
      signaling/action and (2) oral glucose tolerance and beta cell function. Dapagliflozin is a
      potent, highly specific inhibitor of renal glucose transport [SGLT2].
    

Detailed description: 
      "Glucotoxicity" has been implicated as a cause of insulin resistance and impaired beta cell
      function in T2DM. Abundant support for the glucotoxicity hypothesis has been provided by in
      vivo and in vitro studies in animals, but a rigorous test of this hypothesis in man is
      lacking. The investigators propose to test the glucotoxicity hypothesis by chronically
      reducing the plasma glucose in type 2 diabetic subjects (T2DM) with an inhibitor of renal
      glucose transport, dapaglifozin, and examining the effect of restoration of normoglycemia on
      mitochondrial function and insulin signaling/sensitivity. Lastly, the investigators will test
      the "glucolipotoxicity" hypothesis, which states that the toxic effects of elevated plasma
      FFA on insulin sensitive tissues (i.e., muscle) are magnified in the presence of concurrent
      hyperglycemia. Thus, high glucose levels increase malonyl CoA, which inhibits CPT I, leading
      to accumulation of FACoA/DAG, which impair mitochondrial function and inhibit insulin action.
    

Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Treatment arm, 10 mg per day for 2 weeks; Patients are treated with placebo
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Insulin sensitivity; Mitochondrial function; Glucose toxicity; Glucosuria