bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and Pharmacokinetics of AUT00206 in Patients With Schizophrenia, and Also Explores the Effects of AUT00206 on Relevant Central Biomarkers.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety, tolerability, PK and PD profile of AUT00206 after
      repeated doses in patients with stable but symptomatic schizophrenia, taking one or two
      established anti-psychotic drugs. The subjects will undergo brain imaging, tests of cognition
      and tests of auditory function and electrophysiological measures in addition to routine
      safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a
      key objective is to characterize this range of biomarkers which will inform the future
      development of the drug.
    


Intervention name(s): AUT00206; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 capsules of 200mg AUT00206, twice daily, to take orally with food for 4 weeks; 4 capsules of placebo, twice daily, to take orally with food for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Omacor (omega-3-acid
      ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein
      cholesterol (non-HDL-C) in hypertriglyceridemic subjects.
    

Detailed description: 
      Randomized, double-blind, placebo-controlled, parallel-group study design with eleven clinic
      visits (one screening visit, three lead-in/baseline visits, and seven treatment visits) After
      a 4-week diet only lead-in period, subjects with a triglyceride (TG) level in the high to
      very high range and with non-HDL-C level above NCEP ATPIII goals will be randomized to
      receive either open-label atorvastatin 10 mg per day plus double-blinded Lovaza 4g (4 x 1g
      capsules) per day OR open-label atorvastatin 10 mg per day plus a double-blinded matching
      placebo (4 corn oil capsules per day) for 8 weeks After the initial 8-week treatment period,
      the dose of open-label atorvastatin will be titrated to 20 mg per day (with the Lovaza or
      matching placebo corn oil doses remaining at 4 capsules per day) for an additional 4 weeks At
      Week 12, a second open-label titration to 40 mg of open-label atorvastatin per day will be
      maintained for an additional 4 weeks (again with the Lovaza or matching placebo corn oil
      doses remaining at 4 capsules per day)
    

Intervention name(s): Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin; atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Lovaza + atorvastatin; atorvastatin + placebo
Other intervention name(s): Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Lovaza; Hyperlipidemias; Triglycerides; Lipids; omega-3 fatty acids; Hypercholesterolemia; Hypertriglyceridemia; omega-3-acid ethyl esters; Omacor; Dyslipidemias
Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 in Mucopolysaccharidosis III, Type B (MPS IIIB)
Condition: Mucopolysaccharidosis IIIB
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis III
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Study to evaluate the safety and tolerability of intravenous (IV) administration of SBC-103
      in participants with mucopolysaccharidosis III, type B (MPS IIIB, Sanfilippo B) with
      evaluable signs or symptoms of developmental delay.
    

Detailed description: 
      This study was designed as a 3-part study to evaluate the safety and tolerability of IV
      administration of SBC-103. Participants enrolled in Part A (0.3, 1.0, or 3.0 milligrams [mg]
      per kilogram [kg] of SBC-103 administered every other week [QOW] for 24 consecutive weeks).
      Participants who completed Part A were eligible for Part B (an increase to 1.0 or 3.0 mg/kg
      QOW). Participants who completed Part B were eligible for Part C (5.0 and/or 10.0 mg/kg to
      continue through Week156; no participants received both 5.0 and 10.0 mg/kg). Due to the early
      termination of the SBC-103 development program, including this study, all participants
      withdrew from Part C at the sponsor's decision. As a result of the early termination of this
      program, this report provides only safety data.
    

Intervention name(s): SBC-103
Intervention type(s): Drug
Other intervention name(s): recombinant human alpha-N-acetylglucosaminidase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MPS IIIB; Mucopolysaccharidosis; Mucopolysaccharidosis type IIIB; Sanfilippo Syndrome; Metabolism, Inborn Errors; Metabolic Diseases; Genetic Diseases, Inborn; Carbohydrate Metabolism, Inborn Errors; Connective Tissue Diseases; Lysosomal Storage Diseases; Mucinoses; Mucopolysaccharidoses; Pathologic Processes
Ovarian Hormones and Stress Induced Drug Craving
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional

Summary: 
      The study is investigating the impact of progesterone and estrogen on brain areas that are
      involved with stress response and drug craving. The study will involve 40 women who will
      participate in the Montreal Imaging Stress Task (MIST) while undergoing fMRI scanning
      procedures. Half of the women will complete the procedures during the luteal phase of the
      menstrual cycle; the other half will complete procedures during the follicular phase.
      Subjective and physiological measures (cortisol levels) will be used to measure stress and
      craving response. Hypothesis 1A is that all women will exhibit increased craving, stress
      response, salivary cortisol and BNST and limbic nuclei activation in response to the MIST
      task. Hypothesis 1B is that these increased responses will be higher for women in the luteal
      phase than for women in the follicular phase of the menstrual cycle.
    


Intervention name(s): Montreal Imaging Stress Task
Intervention type(s): Behavioral
Intervention description(s): Math task developed to induce a stress response in a laboratory setting
Other intervention name(s): MIST
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics and safety/tolerability between
      NVP-1805-R1 and NVP-1805-R2
    

Detailed description: 
      pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2
    

Intervention name(s): NVP-1805-R1; NVP-1805-R2; NVP-1805-R1 and NVP-1805-R2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet, multiple oral dosing; 1 tablet, multiple oral dosing; NVP-1805-R1,1 tablet and NVP-1805-R2, 1 tablet, co-administration, multiple oral dosing
Other intervention name(s): NVP-1805-R1(M); NVP-1805-R2(C); NVP-1805-R1(M) and NVP-1805-R2(C)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of OATP1B1 and BRCP Genotype on Rosuvastatin PK, PD and Lipidomics in Hyperlipidemic Patients
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to investigate the pharmacokinetics, lipid lowering effect and
      lipidomic profiles of 8-weeks rosuvastatin treatment by OATP1B1 genotype in hyperlipidemia
      patients.
    

Detailed description: 
      Within 3 weeks prior to the first administration of study drug, volunteers who agreed the
      participation of this study by their written consent will undergo screening, including
      physical examination and clinical laboratory test etc, to evaluate whether they are eligible
      to participate in this study. Study drugs will be administered at about 9 A.M. in the morning
      of the first drug administration day, after blood collection for evaluation of
      pharmacokinetics, lipid profiles, metabolomics and urine collection for metabolomic and
      genetic analyses.

      Subjects should take the investigational product by themselves every morning for 8 weeks. On
      the days of 2nd, 4th, 6 and 8th week, blood collection for evaluation of pharmacokinetics,
      lipid profiles, metabolomics and urine collection for metabolomics will be conducted by
      visiting the clinical trials center. On the days of 2nd, 4th and 6th week, the study drug
      will be taken after blood and urine collection.
    

Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): Oral administration of rosuvastatin 20 mg once daily for 21 days.
Other intervention name(s): Crestor Tablet 20 mg manufactured by Astrazeneca
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OATP1B1; Rosuvastatin; lipidomics; pharmacodynamics
Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
Condition: Diarrhea; HIV Infections
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      To perform preliminary clinical testing of diethylhomospermine (DEHSPM), a polyamine
      analogue, for refractory AIDS-related diarrhea.

      Possibly, DEHSPM will reduce stool volume and frequency in patients with refractory
      AIDS-related diarrhea.
    

Detailed description: 
      Possibly, DEHSPM will reduce stool volume and frequency in patients with refractory
      AIDS-related diarrhea.

      Patients are initially hydrated for 24 hours, followed by a 3-day baseline period. They then
      receive intravenous infusions of DEHSPM three times per day for 3 days, followed by
      observation for 3 days.
    

Intervention name(s): Diethylhomospermine
Intervention type(s): Drug
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antidiarrheals; Diarrhea; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; N(1),N(14)-bis(ethyl)homospermine
Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The current study is being conducted in patients with major depression. The study aims to 1)
      investigate the combined effects of selective serotonin reuptake inhibitor (SSRI) and
      bupropion compared to SSRI alone on the improvements of depressive symptoms, fatigue,
      hypersomnia, and neurocognitive functions, 2) observe structural/functional/chemical changes
      using magnetic resonance imaging (MRI), 3) and examine a relationship between the
      improvements of depressive symptoms, fatigue, and hypersomnia and the neural changes.
    


Intervention name(s): Bupropion, Escitalopram; Escitalopram
Intervention type(s): Drug; Drug
Intervention description(s): Week 0-1: Escitalopram 10mg, Bupropion 150mg Week 2-3: Escitalopram 10mg, Bupropion 300mg Week 4-8: Escitalopram 20mg, Bupropion 300mg; Week 0-3: Escitalopram 10mg Week 4-8: Escitalopram 20mg
Intervention MeSH terms: Dexetimide; Citalopram; Bupropion; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
High Intensity Multi-Modal Exercise Training in Postmenopausal Women
Condition: Postmenopausal Osteoporosis; Postmenopausal Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal
Study type: Interventional

Summary: 
      in Pakistan 9.9 million people are osteoporotic and 7.2 million amongst them are women.
      Globally after every 3 seconds there is occurrence of fragility fracture.In Pakistan females
      carries different risk factors based on distinct culture, environment, diet and lifestyle. So
      there is dire need to conduct more high quality clinical trials at National level in order to
      establish strong evidence in favor of low cost but highly effective exercise protocols for
      such a significant public health issue.
    

Detailed description: 
      In postmenopausal age, women bones get weak and easily fracture after 50years. In Pakistan
      every other female is silently suffering from this disease leading to bone, joint pain and
      disability. This project is innovatively designed first time in Pakistan to target weak bones
      of women with high intensity, progressive exercise training. The objectives of this study are
      to determine the effects of a high intensity multi-modal exercise training on bone mineral
      density and functional performance in postmenopausal women.

      After initial screening based on history, subjective fracture risk calculations and
      subjective osteoporosis screening. Females fulfilling criteria and willing to participate in
      exercise trial will be recruited in the study. At baseline, DEXA scan will be done for
      Femoral and lumbar bone density. All performance based testing for functional performance
      outcome measures would be done at baseline, after 3 months & after 6 months. Patient will be
      called twice a week for 8months and DEXA will be repeated after 8months of training. It is
      hypothesized that supervised exercise training will improve bone mineral density and
      functional performance in postmenopausal women with low bone mass.
    

Intervention name(s): High Intensity Exercises; General Exercises
Intervention type(s): Other; Other
Intervention description(s): Supervised High intensity Progressive Resistance Training, High intensity weightbearing/Impact exercises and High challenging Balance Training will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months.; Supervised general fitness exercises including general body stretches, treadmill walking, mild to moderate intensity progressive resistance training & balance exercises will be given. 2 times/week for 40-50minutes session progressively over the duration of 8 months
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a Single factor, Pretest-Postest Control group Design with parallel assignment of patients into two groups.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse
Condition: Prostate Cancer; Interstitial Radiation; High Dose Rate Brachytherapy; Ultrasound-based Planning Compared to CT-based Planning
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      High Dose Rate (HDR) temporary prostate brachytherapy offers a precise form of dose
      escalation for prostate cancer. Needles are placed, the position is confirmed and treatment
      is delivered. Previously High Dose Rate prostate brachytherapy was performed under
      TransRectal UltraSound (TRUS) guidance but planned with Computed Tomography (CT) imaging
      which introduced a source of error through needle displacement while transporting and
      repositioning patient. Recently Varian has introduced a one-step procedure where both implant
      and planning are based on UltraSound imaging and performed without patient repositioning.
      This planning system is approved by Health Canada and is commercially available.

      This study will use High Dose Rate brachytherapy to treat 20 men. Treatment will be planned
      with TransRectal UltraSound and validated using Computed Tomography imaging.
    

Detailed description: 
      Twenty men with intermediate risk prostate cancer, suitable for the combination of external
      beam radiotherapy and High Dose Rate brachytherapy will be entered in this study. High Dose
      Rate brachytherapy will be performed using TransRectal UltraSound guidance and then planned
      using both cone-beam Computed Tomography and TransRectal UltraSound. Planning by Computed
      Tomography is to check the reliability and reproducibility of UltraSound imaging to correctly
      identify the needle positions. Correct needle localization is essential because this is the
      basis for determining source dwell positions, dose calculation and dose optimization.
    

Intervention name(s): HDR prostate brachytherapy
Intervention type(s): Radiation
Intervention description(s): HDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a "boost" combined with external beam radiotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate cancer; interstitial radiation,; brachytherapy
Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain
Condition: Low Back Pain, Mechanical
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study compares the effect of multidimensional physiotherapy to usual evidence-based
      physiotherapy in the treatment of chronic nonspecific low back pain in adults. Half of the
      participants will receive multidimensional physiotherapy based on biopsychosocial approach
      while the other half will receive usual evidence based physiotherapy.
    

Detailed description: 
      multidimensional physiotherapy treatment include: psychoeducation based on cognitive
      behavioral therapy (CBT), education, graded exposure, postural correction exercise, lifestyle
      change, and electrotherapy.

      usual evidence-based physiotherapy include: electrotherapy, education, and trunk general
      exercises.
    

Intervention name(s): Multidimensional physiotherapy; Usual physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Multidimensional physiotherapy based on biopsychosocial approach; Usual evidence based physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Disability; Pain catastrophising; Quality of life; Fear of movement; Chronic non specific low back pain
Haptoglobin and Iron in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      This is a case/control epidemiology study to identify what are the iron-metabolism
      abnormalities in Parkinson's disease (PD) patients, and risk factors relevant to PD
      predisposition.
    

Detailed description: 
      A total of 342 participants, 100 PD patients and 242 age- and gender matched controls, were
      included in the study. All study participants were seen for one study visit in the morning at
      one of two Bastyr University Clinics in the Seattle area. Study participants were fasting at
      the time of the visit. During the study visit, participants donated a blood sample for the
      blood tests and complete an epidemiology questionnaire.

      A subset of 51 of the study participant who were seen for the visit at Bastyr University,
      underwent brain scan and Magnetic Resonance Imaging (MRI), at the University of Washington
      Department of Radiology. The MRI part of the study aims at estimating brain iron levels.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Parkinson's disease patients will be included in the study if they received a diagnosis of
        Parkinson's disease that meets the United Kingdom Brain Bank (UKBB) clinical criteria of
        Parkinson's disease diagnosis.

        Control participants will be included in the study if free of neurodegenerative diseases.

        A subset of the study participants (60 total) receive Magnetic Resonance Imaging to
        estimate brain iron
      
Biospecimen description: 
      We collect serum and plasma samples during the study, that were tested for total serum iron
      and iron-binding proteins.
    
Keywords: Iron metabolism; MRI; risk factors; haptoglobin phenotype
Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to compare the pharmacokinetic profiles of extended-release and
      immediate-release trazodone formulations
    

Detailed description: 
      The bioavailability of once-daily trazodone extended-release 300 mg caplets (test product)
      and trazodone immediate-release 100 mg tablets administered q8h (reference product) will be
      compared in healthy adult volunteers in a randomized, crossover fashion. Morning doses will
      be administered after an overnight fast. Blood samples will be collected predose and at
      pre-defined times over 72 hours following the morning dose. Pharmacokinetic parameters will
      be analyzed using ANOVA. Comparative bioavailability will be assessed on the basis of the
      ratio of least-squares means and/or 90% confidence interval criteria.
    

Intervention name(s): Trazodone HCl; Trazodone HCl
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg immediate-release tablet, dosing q8h; 300 mg extended-release caplet, single dose
Other intervention name(s): Oleptro
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioavailability; pharmacokinetics; healthy; crossover; trazodone