bioihbjkbjnl/mcl2 huggingface dataset:
A Healthy Volunteer Study to Assess the Relative Bioavailability of 2 Forms of SB773812 Tablets.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to compare PK of a new 120mg tablet with two 60mg tablets. This is required because we
      plan to have only single tablets administered in the later phase clinical trials but we have
      not had a 120mg strength before. As this is a new previously untested strength we need to
      ensure that the PK is similar to that achieved using 2x60mg before we start a large
      manufacturing campaign and before we administer to a large number of patients. The study is
      planned to consist of a single part, with two dosing periods, periods 1 and 2 consisting of
      18 subjects. There will be 20 days washout between each dose. Initially 4 subjects will be
      given a single oral dose of 120 mg SB-773812 and 2 will be given placebo. If 120mg SB-773812
      is well tolerated in the first four volunteers, the remaining 12 subjects will be dosed. If
      the 120mg single oral dose in the first 4 subjects is poorly tolerated, the study will be
      stopped. Subjects will return to the centre for follow-up 14 to 21 days after the final
      dose.It is expected that the total duration of the study should be approximately 11 weeks.
    


Intervention name(s): SB- 773812 60 mg; SB- 773812 120 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SB- 773812 will be available dose strength of 60 mg and administered orally by subjects.; SB- 773812 will be available dose strength of 120 mg and administered orally by subjects.; Placebo tablets will be administered orally by subjects.
Other intervention name(s): SB- 773812
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Healthy Volunteer
Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol
Condition: Pharmacokinetics; Pharmacodynamics
Study type: Interventional
Phase: Phase 4

Summary: 
      Tramadol is an opioid analgesic, which is widely used in the treatment of acute and
      neuropathic pain. After oral administration, tramadol is rapidly and almost completely
      absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed
      by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation
      is catalysed by CYP2D6. The formation of inactive metabolites is catalysed by CYP3A4 and 2B6.
      This study is aimed to investigate the possible interaction of oral tramadol with
      itraconazole and ticlopidine, which are inhibitors of CYP3A4 and 2B6. Twelve healthy male or
      female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of the
      ideal weight for height are taken into the study. Primary endpoints of the study are plasma
      concentrations of tramadol and its metabolites.
    


Intervention name(s): Placebo; Ticlopidine; Ticlopidine and itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The subjects will be given orally placebo twice a day for 5 days prior to the study.; The subjects will be given orally ticlopidine 250mg twice a day for 5 days prior to the study.; The subjects will be given orally ticlopidine 250mg twice a day and itraconazole 200mg as a single daily dose for 5 days prior to the study.
Intervention MeSH terms: Itraconazole; Ticlopidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Study for the Treatment of Chronic Idiopathic Urticaria With High Doses of AERIUS (Desloratadine) (Study P04849)
Condition: Chronic Idiopathic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate the effectiveness of desloratadine at doses higher (10 mg and 20
      mg) than currently approved (5 mg) for the treatment of chronic idiopathic urticaria.
      Subjects with chronic urticaria who are currently taking a second generation antihistamine
      will be treated with desloratadine (5, 10, or 20 mg) for 28 days.
    


Intervention name(s): 5-mg Desloratadine; 10-mg Desloratadine; 20-mg Desloratadine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5-mg desloratadine tablets, once daily for four weeks.; 10-mg desloratadine tablets, once daily for four weeks.; 20-mg desloratadine tablets, once daily for four weeks.
Other intervention name(s): SCH 34117, Clarinex, Aerius; SCH 34117, Clarinex, Aerius; SCH 34117, Clarinex, Aerius
Intervention MeSH terms: Loratadine; Desloratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Smoking on Periapical Healing After NSRCT
Condition: Apical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Observational

Summary: 
      Goal of this prospective observational study is determine effect of smoking on periapical
      healing after NSRCT. Population includes systemically healthy smokers with radiographic
      evidence of apical periodontitis will be recruited and compared with same type of population
      of non smokers after non surgical root canal treatment intervention in both the groups.
      Outcome will be assessed using periapical index scoring system at 6 and 12 months follow up
      period
    

Detailed description: 
      The clinical and radiological success of primary non-surgical endodontic treatment in smoker
      & nonsmoker patients will be compared between both groups and smoking cessation effect on
      periapical healing will be assessed.

      The correlation between the self-reported smoking status & smoking status by urine analysis
    

Intervention name(s): Non Surgical Root Canal Treatment
Intervention type(s): Procedure
Intervention description(s): After administration of LA and rubber dam isolation, access cavity will be prepared using carbide burs in high speed hand piece with copious irrigation. Working length will be determined using root ZX apex locator and will be verified radiographically. Canal preparation will be done with rotary instruments . 5ml of 5.25% NaOCl will be used as irrigant after each instrument. After instrumentation , the canals will be irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals will be dried with absorbent paper points, filled with calcium hydroxide paste and access cavity will be restored with IRM. Patients will be recalled after 1 week.At the next appointment, after paste removal, copious irrigation with 5.25% NaOCl will be done and canals will be dried with paper points. Canals will be obturated with Gutta-Percha and ZOE based sealer.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Smokers of age 18 years (male/female) and above having apical periodontitis with age and
        gender matched controls will be enrolled in the study.
      
Biospecimen description: 
      urine analysis
    
Keywords: apical periodontitis, periapical pathology, smokers, non-smokers
Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      A total of 120 patients with pathologically confirmed locally advanced low-risk
      nasopharyngeal carcinoma were enrolled. They were randomly divided into two groups, with 60
      patients in each group. One group was treated with intensity-modulated radiation therapy
      (IMRT) combined with Endostar and the other group was treated with IMRT combined with
      concurrent chemotherapy. The short term efficacy and the toxic and side effects of these
      treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free
      survival of patients were analyzed. Our data may provide an alternative option for the
      treatment of locally advanced low-risk nasopharyngeal carcinoma with high efficacy and low
      toxicity.
    

Detailed description: 
      This study was a multicenter, open-label, randomized controlled clinical trial. A set of
      unified standards were used, including the clinical research program, inclusion criteria,
      exclusion criteria, chemoradiotherapy regimen and evaluation criteria. Nine medical centers
      participated in this study and 120 patients with pathologically confirmed locally advanced
      low-risk nasopharyngeal carcinoma were enrolled. These patients were stratified according to
      clinical stage and participating center, and were randomly divided into two groups: IMRT
      combined with Endostar group ( IMRT 70-74Gy, Endostar 7.5mg / m2, 2 cycles of continuous
      intravenous pumping, and 2 cycles of maintenance therapy after radiotherapy) and IMRT
      combined with concurrent chemotherapy group ( IMRT 70-74Gy, DDP 100mg / m2, intravenous
      infusion over 2 hours , for 2-3 cycles). After treatment, follow-up was performed every 3
      months. The treatment toxicity, local control rate, distant metastasis-free survival, overall
      survival, progression-free survival were observed and assessed.
    

Intervention name(s): endostar; DDP; IMRT
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Endostar 7.5mg / m2, 2 cycles of continuous intravenous pumping for ten days,and 2 cycles of maintenance therapy after radiotherapy; DDP:100mg/m2 for 2-3 cycles; IMRT:70-74Gy for 2-3 cycles
Intervention MeSH terms: Endostar protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nasopharyngeal carcinoma; endostar; IMRT; chemoradiation
Validation of the STarT Back Screening Tool in the Military
Condition: Low Back Pain; Lumbago; Radiculopathy; Intervertebral Disc Disorder
MeSH terms: Radiculopathy; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This is a trial to validate the use of the STarT Back Screening Tool (SBST) in the Military
      Health System for patients with low back pain presenting to primary care.
    

Detailed description: 
      Subjects with low back pain presenting to primary care will be enrolled in a study that aims
      to evaluate the utility of the SBST for providing risk-stratified care. The concept of this
      approach revolves around matching treatment to patients based on their risk for developing
      chronic disability from back pain. Those at low risk receive less treatment, and those at
      high risk need more specialized treatment, that includes psychosocially-focused and cognitive
      considerations. This approach will be compared to usual care, where general practitioners
      carry out the course of action they think best for each patient, without any other guidance.
      Patients will be followed for 1 year.
    

Intervention name(s): Risk Stratified Care; Usual Care
Intervention type(s): Procedure; Procedure
Intervention description(s): Physical therapists providing care will all have attended live training in PIPT principles and be involved in monthly continuing education on these principles. The use of specific principles is guided by the patient's risk stratification (as determined by the STarT Back Tool).
Medium Risk:
- Reassurance will be provided to address specific concerns related to their LBP and implications on work
High Risk:
- Physical therapy will be psychologically augmented with the assessment of biopsychosocial risk factors and the adoption of cognitive behavioral principles that explore patient concerns and address unhelpful beliefs and behaviors, including tailored education (e.g., stress management and pain neuroscience), graded exercise, & graded exposure; Usual care at the general practitioner's discretion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Back Pain; Risk-Stratified Care
Evaluation of a Desipramine Ceiling in Cocaine Abuse - 1
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to confirm whether a blood level ""ceiling"" exists on
      desipramine effect in cocaine abuse.
    


Intervention name(s): Desipramine
Intervention type(s): Drug
Intervention MeSH terms: Desipramine
Primary purpose: Treatment
Keywords: cocaine dependence
240 mL Water Drink Study
Condition: Healthy
Study type: Interventional

Summary: 
      The GI MRI Research group at the University of Nottingham has been developing new,
      non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract.
      The investigators now want to characterise; in collaboration with the College of Pharmacy at
      the University of Michigan, the fasting volumes of gastric and small bowel liquid and their
      time courses over 2 hours after drinking the FDA recommended 240 mL of water drink for oral
      solid dosage forms testing.
    

Detailed description: 
      Solid oral delivery is the most frequently used route of administration for pharmaceutical
      drug products. Along with other important physiological parameters, the volume of liquid in
      the small intestine (SILV) has the potential to greatly influence the rate and extent of drug
      dissolution and absorption in the GI tract, or "oral bioperformance". Modeled small bowel
      absorption of a drug can vary by more than five-fold as SILV decreases from 500 to 50 ml. To
      obtain reasonable predictions of oral bioperformance scientists must design meaningful in
      vitro dissolution tests and mechanistic drug transport models that capture the range of SILV
      in humans. However, little is known about liquid volumes in the gut, mostly due to
      invasiveness of previous techniques. A recent study has drawn great attention to the
      possibility of the liquid in the small intestine existing in discrete liquid "pockets" hence
      it would also be desirable to monitor the time courses and volumes of individual water
      pockets in the small intestine.

      Magnetic resonance imaging (MRI) is the ideal tool to carry out serial and non-invasive
      imaging of gastrointestinal function. MRI is inherently suited to image liquid materials and
      this ability has been exploited to image liquids in the undisturbed gastrointestinal tract.
      Gastric emptying measurements have been long established and validated. Small bowel liquid
      volumes measurements have been recently validated against naso-duodenal infusion. Ultimately,
      the findings with this study will provide novel insights on the volume and distribution of
      ingested liquids in the gastrointestinal tract.
    

Intervention name(s): Spring water
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gastrointestinal physiology; MRI; Small bowel water volumes; Gastric volumes
Randomized Safety Study of CVT-301 Compared to an Observational Control Group
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a 12-month, open-label, randomized, multicenter study which will evaluate the
      safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in
      Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will
      include a concurrent observational cohort of PD patients managed using the usual standards of
      care.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled, Phase 2b study in patients with PD
      (CVT-301-003) demonstrated clinically important, and statistically significant
      CVT-301-associated improvements in motor function at doses of 35 and 50 mg LD FPD, compared
      with placebo, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) motor
      assessment (Part 3); furthermore, CVT-301 was generally safe and well tolerated. A Phase 3,
      randomized, placebo-controlled study designed to assess the efficacy and safety of 35 mg and
      50 mg FPD as an adjunct to a CD/LD regimen in the treatment of OFF symptoms over 12 weeks
      (CVT-301-004) was conducted in parallel with this study.
    

Intervention name(s): CVT-301; Observational cohort
Intervention type(s): Drug; Other
Other intervention name(s): Inhaled levodopa
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Motor fluctuations; levodopa; inhaled drugs; OFF episodes
Pramipexole to Target "Anhedonic Depression"
Condition: Depression, Bipolar; Depression, Unipolar; Dysthymia; Anhedonia
MeSH terms: Anhedonia; Depression; Depressive Disorder; Dysthymic Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The heterogeneity of depression suggests that different neurocircuits and pathophysiological
      mechanisms are involved. Anhedonia - the inability to experience pleasure from, or the lack
      of motivation to carry out, usually enjoyable activities - is an endophenotype within the
      depression spectrum, with a distinct pathophysiology of dopaminergic mesolimbic projections.
      Anhedonia is common in depression and associated with treatment resistance. Pramipexole, an
      agonist to the dopamine -receptor 3, is an established treatment of Parkinson's disease.
      Based on its mechanism of action, pramipexole might be efficacious in a subtype of depression
      characterized by anhedonia and lack of motivation - symptoms linked to dopaminergic
      hypofunction. In this proof-of-concept pilot study the investigators test the anti-anhedonic
      and antidepressant effects of add-on pramipexole using an "enriched population study design"
      including only depressed patients with significant anhedonia. To understand the neurobiology
      of anhedonia in depression and to identify treatment predictors, the investigators also do
      assessments of anhedonia-related neurocircuitry using (f)MRI and blood biomarkers.
    


Intervention name(s): Pramipexole Pill
Intervention type(s): Drug
Intervention description(s): Add-on pramipexole
Intervention MeSH terms: Pramipexole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Relationship Between MDSCs and NK Cells Activity of CHC Patient Treated by DAAs
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Hepatitis C virus (HCV) infection is easy to chronic and can progress to cirrhosis and liver
      cancer. Direct-acting antiviral treatment can significantly improve the prognosis of the
      disease and the efficacy is seemingly not affected by a variety of viral factors. In
      addition, direct-acting antiviral agents therapy may affect the transformation of the immune
      cells and ameliorate the host immune status consequently. This study mainly investigated the
      relationship between Direct Acting Antiviral Treatment effect and the functional activity of
      myeloid-derived suppressor cells (MDSCs) and natural killer cells (NK cells) in Chronic
      Hepatitis C.
    

Detailed description: 
      32 treatment-naive CHC patients and 20 healthy controls were recruited. Patients were
      examined before DAAs therapy (0w) and at weeks 4 (4w) and weeks 12 (12w) and weeks24 (24w) of
      the therapy. The percent age of myeloid-derived suppressor cells and NK cells of the
      peripheral blood were analyzed by flow cytometry. The investigators discuss the relationship
      between direct acting antiviral treatment effect and myeloid-derived suppressor cells and NK
      cells activity in chronic hepatitis C.
    

Intervention name(s): Ledipasvir-Sofosbuvir; Daclatasvir-Sofosbuvir
Intervention type(s): Drug; Drug
Intervention description(s): 15 CHC patients were treated with Sofosbuvir (400mg, qd)/Ledipasvir (90mg, qd) for 12 weeks; 17 CHC patients were treated with Sofosbuvir (400mg, qd)/Daclatasvir (60mg,qd) for 12 weeks.
Other intervention name(s): Harvoni; Daklinza
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: There are 32 treatment-naive CHC patients who treated by Ledipasvir-Sofosbuvir or Daclatasvir-Sofosbuvir.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chronic Hepatitis C; direct-acting antiviral agents; Myeloid-Derived Suppressor Cells; NK cells
"Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy of Chloroquine comparing with placebo for
      treatment of non- response HCV patients.. In this triple blind pilot study, 20 patients with
      confirmed chronic hepatitis C will be randomize into treatment group (Chloroquine 150 mg
      daily, for 8 weeks) or control group (placebo once daily, for 8 weeks). Patients who have
      receiving anti neoplastic, anti viral or Immunomedullator drugs during 6 months prior to
      study, have co-infection Hepatitis A,C,D or HIV, severe liver or renal dysfunction, are
      pregnant or breast fed, or refuse to sign informed consent will be excluded.. At the end of
      therapy (12 weeks) and at baseline, first, second and third month after receiving drug and
      placebo HCV Virus load, CBC LFT and biochemical parameters will be evaluated and compared
      between groups.
    


Intervention name(s): 150 mg/daily chloroquine compare to placebo for 12 week; Chloroquine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Chloroquine; Chloroquine diphosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment