bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Prucalopride in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study healthy volunteers received increasing doses of prucalopride to study the
      tolerability and cardiac safety of prucalopride. The study hypothesis was that prucalopride
      at doses up to 10 mg has no clinically relevant effect on the cardiovascular safety in
      healthy volunteers.
    

Detailed description: 
      Single-centre, double-blind, placebo-controlled, cross-over study in 33 healthy volunteers
      with 2 sessions. Each session consisted of a run-in day for baseline assessments, 8 treatment
      days and 5 additional days for followup assessments. Subjects were randomised to start with
      either the prucalopride or placebo session. The prucalopride dose was consecutively escalated
      in 2 mg steps per day, starting from 2 mg up to 10 mg once daily If a subject did not
      tolerate the 10- or 8-mg dose, 1 step back in the dosage scheme was allowed, from 10 to 8 mg
      on Day 6, or from 8 to 6 mg on Day 5. Subjects with intolerance for doses of less than 6 mg,
      were withdrawn from the study. Repeated dosing (6, 8 or 10 mg) was continued once daily until
      Day 8, to achieve steady-state. During placebo, the number of placebo tablets was
      consecutively escalated in an identical way as described for prucalopride. Between the 2
      sessions, there was a washout period of 14 to 21 days, to avoid any carry-over effect.
    

Intervention name(s): Prucalopride; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Prucalopride
Keywords: electrocardiographic safety; pharmacokinetics
Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year
Condition: Multiple Myeloma; Breast Cancer
MeSH terms: Breast Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK)
      profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients
      treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.
    


Intervention name(s): Zoledronic acid
Intervention type(s): Drug
Other intervention name(s): ZOL446
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple myeloma; breast cancer; zoledronic acid; pharmacokinetics
Investigation How CG5503 is Taken up and Excreted From the Body After 2 Minutes Intravenous Infusion With and Without Oral Co-administration of Charcoal
Condition: Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase I study in 12 healthy male participants to compare the pharmacokinetic
      properties of CG5503 (how it is taken up and excreted from the body) after 2 minutes
      intravenous (i.v.) infusion with and without oral co-administration of charcoal to
      investigate a potential gastrointestinal secretion of CG5503.

      During the course of the study each participant received two infusions of 40 mg CG5503
      without (treatment A) and with (treatment B) oral co-administration of charcoal. In treatment
      B, eight doses of 5 grams charcoal powder were co-administered orally at defined time points.
      The wash out phases were to be at least 4 to 14 days between the treatment periods.
    


Intervention name(s): 4 ml CG5503; 5 g charcoal powder
Intervention type(s): Drug; Drug
Intervention description(s): 4 ml of the CG5503 infusion solution corresponding to 40 mg CG5503 (tapentadol hydrochloride).; Oral administration of 5 g charcoal powder suspended in 100 ml tap water.
Other intervention name(s): Tradename: Kohle-Pulvis Pulver
Intervention MeSH terms: Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The randomization was in the ratio 1:1.
Masking: None (Open Label)
Primary purpose: Treatment
Study of Ovum Donors After Donation
Condition: Anonymous Donors
Study type: Observational

Summary: 
      To explore the attitudes and reactions of ovum donors prospectively after ovum donation and
      to follow their medical histories.
    

Detailed description: 
      Although several studies have explored donor's reactions and experiences up to a year post
      donation, no study has explored how donor attitudes and reactions change over time.
      Currently, there is no long-term data available to describe donor's feelings and reactions to
      their donation. Consequently, programs have no guidance to counsel prospective donors about
      whether donors' attitudes change towards their own participation, contact with any offspring,
      or concerns about the donation. In addition, just as ovum donors' initial health histories
      were shared anonymously with the recipient(s), any updated information gathered in this study
      would be shared anonymously with the recipient(s) or offspring should they request those
      updates.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Anonymous egg donors
      
Keywords: egg donor
8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the short-term effects of two tolvaptan formulations
      in patients with ADPKD.
    


Intervention name(s): Tolvaptan MR; Tolvaptan IR; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50/80 mg capsules; 60/30 mg capsules; tablet
Other intervention name(s): OPC-41061; OPC-41061
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Kidney Disease; Polycystic Kidney Disease; Autosomal Dominant Polycystic Kidney Disease; PKD; ADPKD
Carbohydrate Intolerance Questionnaire Study
Condition: Carbohydrate Intolerance
MeSH terms: Malabsorption Syndromes; Carbohydrate Metabolism, Inborn Errors
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the validity of using a carbohydrate intolerance
      questionnaire (CIQ) and/or other health markers as a means of predicting response to insulin
      sensitivity as determined by an oral glucose tolerance test (OGTT).
    

Detailed description: 
      This study will utilize a carbohydrate intolerance questionnaire (CIQ). Responses to a CIQ
      will be correlated with diet inventories, baseline body composition and health assessments, a
      standard metabolic panel, fasting glucose and insulin levels, a homeostatic insulin
      resistance model (HOMA), a two hour oral glucose tolerance test (OGTT), and a carbohydrate
      sensitivity symptom questionnaire administered during the OGTT.
    

Intervention name(s): TRUTOL Glucose Tolerance Beverage
Intervention type(s): Dietary Supplement
Intervention description(s): A caffeine-free, non-carbonated, glucose tolerance beverage
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare the Pharmacokinetics, Safety, and Tolerability Following Administration of Palovarotene in Healthy Japanese and Non-Asian Subjects
Condition: FOP
Study type: Interventional
Phase: Phase 1

Summary: 
      this study purpose is to assess safety, tolerability and the pharmacokinetic (PK) profile of
      palovarotene in healthy Japanese and matched (with respect to sex, age, and weight) non-Asian
      subjects aged 18 to 55 years.
    


Intervention name(s): palovarotene low-dose; palovarotene high-dose
Intervention type(s): Drug; Drug
Intervention description(s): oral capsules; oral capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The subjects will be randomized to receive in Period 1 either the low-dose or high-dose first, and in Period 2 they received the alternate dose.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to compare the pharmacokinetics (PK) of the abatacept
      drug product converted from drug substance by a new drug substance process (Treatment A)
      relative to the current drug substance process (Treatment B) following a single dose (750 mg)
      intravenous (IV) infusion in healthy participants.
    

Detailed description: 
      Participants will be admitted to the clinical facility the day prior to dosing (Day -1) and
      will be confined until at least 24 hours post-dose. On Day 1, eligible participants will be
      randomized in a 1:1 ratio to either Treatment A or Treatment B. The randomization will be
      stratified by weight categories: >= 60 to < 70 kg, >= 70 to < 80 kg, >= 80 to < 90 kg, and >=
      90 to <= 100 kg.
    

Intervention name(s): Abatacept
Intervention type(s): Drug
Intervention description(s): Participants will receive abatacept at a single dose 750 mg as IV infusion.
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Interaction Study Between Dolutegravir and an Oral Contraceptive Containing Norgestimate and Ethinylestradiol
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3 clinical
      development for the treatment of HIV infection. DTG will likely be used in women on oral
      contraceptives (OC) for birth control. Based on accumulated non-clinical and clinical drug
      metabolism and pharmacokinetic data, there is a low likelihood of drug interaction between
      DTG and most widely used OC drugs. The primary objective of this study is to evaluate the
      effect of DTG administration on the pharmacokinetics and pharmacodynamics of a commonly used
      oral contraceptive product, Ortho-Cyclen (combination of norgestimate and ethinyl estradiol),
      in healthy female subjects. Each subject will participate in a Run-in period (if needed),
      followed by two treatment periods. Approximately 16 subjects will be randomized in a
      cross-over fashion to either Ortho-Cyclen with DTG or Ortho-Cyclen with Placebo for 10 days
      and switch to the alternate treatment for another 10 days. Subjects will return to the study
      center for final follow up evaluations 7 - 14 days after the final dose of study medication.
    


Intervention name(s): Ortho-Cyclen; Dolutegravir; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ortho-cyclen is an oral contraceptive.; Dolutegravir is an experimental HIV drug; Placebo is a tablet with no drug in it
Other intervention name(s): GSK1349572
Intervention MeSH terms: Dolutegravir; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effectiveness of Matrix Rhythm Therapy on Increased Muscle Tone, Balance and Gait Parameters in Stroke Survivors
Condition: Stroke
MeSH terms: Stroke; Muscle Hypertonia
Study type: Interventional

Summary: 
      Matrix-Rhythm-Therapy(MRT) has been included in neuro-rehabilitation program for stroke
      patients to regulate increased muscle tone.

      There are no controlled studies with large sample size on the efficacy of MRT on spasticity.
      In this context,to the best of our knowledge, our study is the first study on this subject.
      The results of the study will develop a new perspective for management of spasticity and will
      ensure more common use of MRT.Further studies are needed on superiority of MRI over other
      treatment methods used in gait and balance rehabilitation of hemiparetic individuals. The aim
      of this study was to investigate the effectiveness of combining Bobath therapy (BT) and MRT
      on muscle tone,balance and gait parameters in stroke individuals with spastic hemiparesis.
    


Intervention name(s): Bobath therapy and Matrix Rhythm Therapy; Bobath therapy
Intervention type(s): Other; Other
Intervention description(s): MRT application that was applied to the study group in addition to the BC was applied to the affected side of the body and lower extremity for 60 minutes in each session.The treatment was started from the thoracic region and a treatment direction was toward the lower extremity in the affected side.During the MRT procedure, the patient's active participation was ensured and the treatment was combined with the exercises.The patients were informed about MRT verbally and in writing before the application. Participants were treated 3 days a week for 4 weeks for a total of 12 sessions.; Both groups were treated with the BC as a neurodevelopmental therapy. Considering individual requirements and wishes of the patient, an exercise program that supports active participation of the person was established.Each treatment session was performed for 60 minutes.The treatment program that was established appropriately according to the patient contained weight transfer to the affected side in different positions,approximation to increase proprioceptive input, providing sensorial input to the sole of the foot using materials such as sensory ball,foot-ankle mobilization,functional reach activities, forward-side step, gait, and balance activities. Participants in both groups were treated 3 days a week for 4 weeks for a total of 12 sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke survivor; spasticity; Matrix Rhythm Therapy; balance; gait
Characterisation of Healthy Volunteers, Asthma and Chronic Obstructive Pulmonary Disease Patients for Inhalation Profile, Pharyngometry, Spirometric Indices and Lung Morphometry
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a clinical study, with no investigational product, to characterise the inhalation
      profiles of healthy volunteers, volunteers with mild, moderate and severe Asthma and
      volunteers with mild, moderate and severe Chronic Obstructive Pulmonary Disease (COPD),
      through the novel dry powder inhaler.
    


Intervention name(s): Inhalation Profiling
Intervention type(s): Procedure
Intervention description(s): All subects recieve Inhaltion Profiling there are no interventions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharyngometry; Novel Dry Powder Inhaler; HRCT; Inhalation Profiles
Wellness Monitoring for Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      The Wellness Monitoring for Major Depressive Disorder (MDD) study is a prospective,
      longitudinal, observational study aimed at identifying biomarkers of relapse in MDD. Results
      may help refine clinical approach to relapse management, and may ultimately help MDD patients
      sustain wellness while on antidepressant medication.
    

Detailed description: 
      This study involves a naturalistic follow up of responders from the study entitled
      "Integrated biological markers for the prediction of treatment response in depression", or
      the CAN-BIND-1 study. In addition, this study is also open to other participants who
      completed other CAN-BIND studies, as well as remitters who meet the inclusion criteria. Since
      patients usually seek medical attention only after relapse has occurred, imminent precursors
      to relapse are not well known. In this study, participants who are currently responding to an
      oral antidepressant treatment regimen and/or therapeutic intervention will be monitored over
      a minimum period of 13 months, which provides a unique opportunity to discover near-term
      biomarkers of relapse.

      The study is conducted in partnership with Janssen Research & Development and utilizes remote
      monitoring technology for data gathering.
    

Intervention name(s): Observational
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and women between 18 to 65 years of age who have previously met DSM-V criteria for
        Major Depressive Episode (MDE) in MDD as determined by MINI, (1) who participated in
        CAN-BIND-1 protocol, (2) other CAN-BIND studies, and (3) other remitters who meet the
        inclusion criteria who are currently responding to antidepressant medication or a
        combination of treatments.
      
Biospecimen description: 
      At each 8 week visit, blood samples for biochemical, genomic, and proteomic analysis will be
      collected and stored at -80'C freezer.

      Plasma: Venous blood will be collected in 6mL and 10ml EDTA blood tubes, followed by
      centrifugation in a refrigerated centrifuge to obtain the plasma. Two milliliters of plasma
      from each tube will be divided into 8 cryovials (500µL).

      DNA for methylation analysis: Venous blood will be collected in 8.5 mL PAXgene DNA tubes.

      DNA for studying histone modifications: Venous blood will be collected in 6mL EDTA blood
      tubes and the mixed contents will be divided evenly into three 2 mL screw-cap tubes.

      RNA for mRNA and miRNA sequencing: Venous blood will be collected in 6mL EDTA blood tubes and
      the mixed contents will be passed through LeukoLOCK filters according to the manufacturer's
      instructions.
    
Keywords: major depression; major depressive episode; biomarkers; relapse; near term relapse; m-health
Wound Healing Abnormalities in Major Abdominal Surgery
Condition: Impaired Wound Healing; Factor XIII Deficiency
MeSH terms: Factor XIII Deficiency; Wounds and Injuries
Study type: Observational

Summary: 
      This clinical observational study investigates the incidence of wound healing abnormalities
      in patients undergoing major abdominal surgery. Second aim of the study is, if wound healing
      deficits may be accompanied by abnormalities in blood coagulation parameters.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing major abdominal surgery
      
Biospecimen description: 
      1) serum samples for measurement of coagulation factors
    
Keywords: major abdominal surgery; coagulation; extracellular matrix proteins; wound healing after major abdominal surgery
ZoNantax - Zolendronic Acid as Neoadjuvant Therapy Plus Anthracycline and Taxane in Locally Advanced Breast Cancer
Condition: Breast Cancer; Breast Disease; Neoplasms; Neoplasms by Site
MeSH terms: Breast Neoplasms; Neoplasms; Neoplasms by Site; Breast Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the association of zoledronic acid with standard
      treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast
      cancer HER 2 positive.
    

Detailed description: 
      This trial combines zolendronic acid with anthracycline followed taxane plus trastuzumab for
      neoadjuvant treatment of HER 2 positive stage II/III breast cancer.

      Zoledronic acid (ZOL) has activity of anti-bone resorption and shows diverse anti-tumor
      effects in vitro. Some chemical and biological characteristics of ZOL indicate potential for
      inhibition of tumor growth in pre clinical studies

      The primary objective of the study is to evaluate the residual cancer burden (RCB) with the
      addition of zolendronic acid to standard neoadjuvant therapy. RCB is calculated as a
      continuous index combining pathologic measurements of primary tumor (size and cellularity)
      and nodal metastases (number and size). RCB index is a significant predictor of distant
      relapse-free survival, and can be used to define categories of near-complete response and
      chemotherapy resistance after neoadjuvant chemotherapy compared with currently used risk
      factors. Additionally, the study will collect tissue biopsies and blood before and after
      treatment in order to correlate clinical outcomes with gene expression and radiologic data to
      predictive response.
    

Intervention name(s): Zo-Nantax
Intervention type(s): Drug
Intervention description(s): Experimental:
AC,Docetaxel,Trastuzumab,Zolendronate
Drug: AC Adriamycin 60mg/m2 IV plus cyclophosphamide 600mg/m2 every 21 days for 4 cycles
Drug: Docetaxel
Docetaxel 100 mg/m2 every 21 days for 4 cycles.
Drug: Trastuzumab
Trastuzumab 8mg/kg [loading dose] once then 6mg/kg IV every 21 days for 3 cycles plus docetaxel.
Drug: zolendronic acid
Zolendronic acid 4mg IV every 21 days for 8 cycles combine with chemotherapy
Other intervention name(s): Other Names:; Adriblastine RD; Cytoxan; Taxotere®; Herceptin®; Zometa
Intervention MeSH terms: Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoadjuvant therapy; Breast cancer HER2 positive; zolendronic acid
Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI)
Condition: Neoplasms
MeSH terms: Neoplasms; Liver Neoplasms
Study type: Observational

Summary: 
      The purpose of this multicenter study is to evaluate the agreement among expert radiologists
      in interpreting magnetic resonance images (MRI) assessing common primary liver tumours in
      non-cirrhotic patients.
    

Detailed description: 
      Magnetic Resonance Imaging (MRI) is currently the method of choice for non-invasive diagnosis
      of primary liver tumors. However, differentiation of hepatocellular carcinoma (HCC) from
      adenoma and focal nodular hyperplasia (FNH) remains challenging, particularly in
      non-cirrhotic patients.
    

Intervention name(s): Non-invasive Magnetic Resonance Imaging (MRI); Liver resection; Histopathology diagnosis of resected liver specimen
Intervention type(s): Other; Procedure; Other
Intervention description(s): Conventional pre-operative MRI; Hepatectomy with an intention to cure; Histopathology diagnosis by expert pathologist.
Other intervention name(s): Magnetic Resonance Imaging; Hepatectomy = liver resection by open surgery.; Examination under the microscope.
Intervention MeSH terms: Liver Extracts
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinics
      
Keywords: Liver; Neoplasms; Magnetic Resonance Imaging; Surgery; Pathology