bioihbjkbjnl/mcl2 huggingface dataset:
Absorption, Metabolism and Excretion of 14C-olorofim in Man
Condition: Invasive Fungal Infections
MeSH terms: Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-centre, open-label, non-randomised, single dose study in 2 cohorts of healthy
      subjects. It is planned to enrol 6 healthy male subjects in Cohort A (standard mass balance
      and metabolite profiling cohort) and up to 6 subjects in Cohort B (biliary evaluation
      cohort); each subject will receive a single oral administration of 120 mg [14C]-olorofim oral
      solution containing approximately 3.7 MBq (100 µCi).
    

Detailed description: 
      Subjects will be screened up to 28 days prior to dosing and eligible subjects will be
      admitted to the Clinical Research Unit (CRU) on the day prior to dosing (Day-1). Each subject
      will be dosed on the morning of Day 1 after an overnight fast.

      Cohort A:

      Subjects will remain resident in the CRU up to 336 h post-dose (Day 15), with whole blood,
      plasma, urine and faeces collected throughout this period. There may be up to two further 24
      h residency periods (Days 21 to 22 and Days 28 to 29) for collection of plasma, urine and
      faeces if discharge criteria are not met.

      Cohorts B1 and B2:

      Subjects will remain resident in the CRU up to 96 h post-dose (Day 5) for collection of
      plasma, urine, faeces and bile. Subjects will return for a short follow-up visit on Day 10.
      Cohort B1 subjects will have bile sampling up to 6 h postdose and Cohort B2 subjects will
      have bile sampling up to 12 h postdose. Cohort B divided into 2 sub-cohorts for logistical
      reasons only.
    

Intervention name(s): Olorofim
Intervention type(s): Drug
Intervention description(s): single oral dose (120 mg, 3.7 MBq)
Other intervention name(s): F901318
Intervention MeSH terms: Olorofim
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
COVID-19 in ART: Perception and Experience
Condition: COVID19; Fertility Issues; ART
MeSH terms: COVID-19; Infertility
Study type: Observational

Summary: 
      Non-urgent medical care, such as fertility treatments, has been massively postponed during
      the past weeks due to the COVID19 pandemic. The lockdown and the closure of IVF centers might
      cause anxiety and depression among infertile couples, who are already exposed to the
      distressing experience of infertility and for whom the wait for a baby already appears
      unending. Few data are available regarding the impact of SARS-CoV-2 on pregnant women and
      foetus, or on fertility.

      This study aims to assess the views of infertile couple regarding the potential risks of
      COVID during their fertility treatment and their personal experience of the COVID pandemic
      and their expectation for further treatment .
    


Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Eligible patients will be selected from our electronical database and invited via email to participate.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infertile couple (male and female) who had a fertility treatment prescribed during the past
        9 months (prescription after October 1st, 2019) in the fertility department of Montpellier
        Hospital
      
Keywords: fertility; risk perception; emotional experience
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine the efficacy of once-daily rosuvastatin
      in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day
      0) to the end of the 12-week double-blind treatment period.
    


Intervention name(s): Rosuvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Nexium
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heterozygous Familial Hypercholesterolemia
Are Two Antidepressants a Good Initial Treatment for Depression?
Condition: Major Depression; Dysthymia; Depression NOS
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Relatively drug naive patients will receive two antidepressant medications as initial
      treatment.
    

Detailed description: 
      While antidepressant medications are often effective in relieving depressive symptoms, at
      least 60% of patients do not remit with the first agent tried. This pilot study will assess
      whether giving two standard medications simultaneously (i.e., Escitalopram and Bupropion) is
      both tolerated and improves response while decreasing drop outs. This is a replication of a
      previous study.
    

Intervention name(s): escitalopram + bupropion
Intervention type(s): Drug
Intervention description(s): same dosing as for monotherapy arms
Other intervention name(s): escitalopram = Lexapro; bupropion = Wellbutrin
Intervention MeSH terms: Dexetimide; Citalopram; Bupropion; Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depression; Dysthymia; Depression NOS; Escitalopram; Bupropion; Dual Therapy; Combination Therapy
Improving Diabetes Outcomes: a Couples Intervention
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      Research has shown that diabetes affects both the patient and family, and that support from
      family and partners helps diabetes patients manage their illness better. However, diabetes
      programs rarely involve the partner. This is a study to develop and test an intervention that
      helps partners and patients who have type 2 diabetes better support each other. The
      intervention will be delivered over the telephone to reach more people. Our hypothesis is
      that an intervention that targets the couple has a greater effect on health and well-being of
      patients than one that targets the individual patient alone.
    

Detailed description: 
      Research has shown that diabetes affects both the patient and family, and that support from
      family and partners helps diabetes patients manage their illness better. However, diabetes
      programs rarely involve the partner. This is a pilot proposal to develop and test an
      intervention that aims to both enlist the support of partners of diabetes patients, and
      enhance and improve the quality of that support. We believe that the intervention will help
      the relationship and also will have a positive impact on medical (e.g.,blood sugar control),
      behavioral (e.g., increased exercise, better diet) and emotional (e.g., depression) outcomes.
      The intervention will be implemented by telephone, in order to enhance the project's ability
      to reach a broader sample of patients.Forty-five couples will be recruited in which one
      partner has type 2 diabetes. After initial testing and basic diabetes education, they will be
      assigned to one of three comparison groups. For those in the intervention groups they will
      participate in 11 telephone contacts with a diabetes educator and a counselor and will
      receive education about diabetes, behavior change, emotional issues/couples communication,
      and problem solving techniques. A manual will include readings, structured homework
      assignments, and self-monitoring logs. They will be re-tested 2 weeks and 3 months after the
      intervention.
    

Intervention name(s): telephone support and behavior change; Diabetes self-management education
Intervention type(s): Behavioral; Other
Intervention description(s): Diabetes self-management education provided over the telephone either for individuals or couples; Limited diabetes self-management education provided over the telephone, serves as an enhanced usual care control intervention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; relationship; social support; behavior change; telemedicine
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (blood levels) and
      pharmacodynamics (the action or effects a drug has on the body) of canagliflozin in children
      and adolescents with type 2 diabetes mellitus aged 10 to 17 years (inclusive). Other purposes
      are to investigate safety and assess the ease of swallowing the tablets.
    

Detailed description: 
      The participants who meet the eligibility criteria, will receive a single dose of placebo (an
      inactive substance that is compared with a drug to test whether the drug has a real effect in
      a clinical trial) and this will be followed by baseline 24 hour pharmacodynamic assessments.
      On the next morning participants will receive the first canagliflozin dose and will be
      discharged home to continue canagliflozin treatment for 13 additional days. There will be 2
      treatment groups (8 participants in each): the first group will receive canagliflozin 100 mg
      daily, the second group will receive either canagliflozin 300 mg or canagliflozin 50 mg
      daily. The canagliflozin dose for the second treatment group will be determined after the
      sponsor has evaluated the results from the first 5 participants. On day 14 of treatment the
      participants will be admitted again for 24 hour pharmacokinetic and pharmacodynamics
      assessments. The participants will continue to take their normal dose and schedule of
      metformin during the entire study. The total duration of the study is approximately 50 days.
    

Intervention name(s): Canagliflozin 100 mg; Canagliflozin 50 mg; Canagliflozin 300 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One 100-mg tablet of canagliflozin orally administered daily for 14 days.; One 50-mg tablet of canagliflozin orally administered daily for 14 days.; One 300-mg tablet of canagliflozin orally administered daily for 14 days.; One matching placebo tablet orally administered at baseline phase.
Intervention MeSH terms: Canagliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Canagliflozin; JNJ-28431754; Pharmacokinetics; Pharmacodynamics; Children; Adolescents
A Study of Absorption, Metabolism, Excretion and Mass Balance After a Single Dose Administration of MK-0941 (MK-0941-016)(COMPLETED)
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose, open label study to characterize the routes of elimination and determine the
      mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male
      participants with type 2 diabetes. After drug administration, blood, urine, and fecal samples
      will be collected to determine relative quantities of 14C-labeled MK-0941.
    


Intervention name(s): MK-0941
Intervention type(s): Drug
Intervention description(s): A single dose of 40 mg of [14C]MK-0941 (160 µCi), taken orally as eight 5-mg capsules
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating the Safety and Efficacy of CLONICEL® to Treat Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether CLONICEL® (clonidine HCl sustained release)
      is a safe and effective treatment for children and adolescents with attention deficit
      hyperactivity disorder (ADHD).
    

Detailed description: 
      Clonidine is a centrally acting alpha2 adrenergic agonist that has been used effectively
      since the early 70s to treat mild to moderate hypertension. In addition to hypertension,
      clonidine has been evaluated and used extensively for several other indications, including
      attention deficit hyperactivity disorder (ADHD).

      An easy to administer clonidine formulation is needed that retains the efficacy of the
      current oral formulation but has an improved safety profile. The current trial will
      investigate the safety and efficacy of clonidine delivered from the sustained release
      formulation of CLONICEL in the treatment of children and adolescents with ADHD.
    

Intervention name(s): high dose clonidine HCl sustained release; low dose clonidine HCl sustained release; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): high dose clonidine HCl sustained release tablets for 8 weeks; low dose clonidine HCl sustained release tablets for 8 weeks; placebo tablets for 8 weeks
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Clonidine; Attention Deficit; Hyperactivity; CLONICEL; Addrenex
The Pharmacokinetic, Safety and Tolerability of Tiotropium in Outpatients With Renal Impairment in Comparison to Healthy Subjects
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate pharmacokinetics of a single i.v. dose of tiotropium (4.8 mcg) in
      patients with renal impairment in comparison to healthy subjects.
    


Intervention name(s): Tiotropium, solution ampoules
Intervention type(s): Drug
Intervention MeSH terms: Tiotropium Bromide
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
Condition: Cardiac Surgery; Cardiopulmonary Bypass
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during
      elective open-heart surgery in pediatric patients.
    


Intervention name(s): Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution; Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): Peri-operative fluid replacement therapy (max 40ml/kg/day); Peri-operative fluid replacement therapy (max 40ml/kg/day)
Other intervention name(s): Volulyte; Voluven
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether the MMF07 Foot Massager and/ or heat therapy
      may improve symptoms of restless legs syndrome (RLS). It will also assess the effect of the
      MMF07 Foot Massager and/ or heat on quality of life and sleep in people affected by RLS.
      Participants will be randomly assigned to one of four treatment groups;

        1. MMF07 Foot Massager device

        2. Heat therapy

        3. Heat therapy and the MMF07 Foot Massage device

        4. Neither heat nor MMF07 Foot Massager device (no treatment group)
    

Detailed description: 
      Few clinical trials have looked into non-pharmacological, non-invasive treatments for
      restless legs syndrome, despite reports that massage, baths and vibrations can alleviate RLS
      symptoms. We would like to assess whether the MMF007 Foot Massager device and/or heat therapy
      is associated with improved severity of RLS symptoms.

      For this study the investigator will enroll 40 participants who have been diagnosed with
      restless legs syndrome, who will be followed over the course of four weeks and asked to
      complete two in person study visits. In the study the investigator is comparing the use of
      the MMF007 Foot Massager device and/ or heat therapy to a non treatment group to assess if
      the symptoms of RLS improve.
    

Intervention name(s): MMF07 Foot Massager; Heat Therapy
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: RLS
Multimodal Assessment of Knee Conditions
Condition: Osteoarthritis; Injury of Anterior Cruciate Ligament; Knee Injuries and Disorders
MeSH terms: Wounds and Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
Study type: Observational

Summary: 
      The purpose of this study is to assess both osteoarthritis and other pathological knee
      conditions from the combination of signals that are known to provide information on the knee
      joint.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Controls will be recruited using the newspaper advertisement. Subject with anterior
        cruciate ligament injuries will be recruited from the orthopaedic department and
        osteoarthritic subjects using patient Records of Oulu University Hospital.
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is undertaken to assess the immune response and safety profile of 4 lots of the
      novel adjuvanted hepatitis B vaccine that were formulated following different processes, with
      Engerix™-B as the control vaccine
    

Detailed description: 
      This is an open, randomized study with five groups, but the four groups receiving HBV-MPL
      candidate vaccine are double-blinded.

      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham
    

Intervention name(s): Engerix™-B; HBV-MPL vaccine 208129
Intervention type(s): Biological; Biological
Intervention description(s): 3-dose intramuscular injection; 2-dose intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; Adjuvanted hepatitis B vaccine; Recombinant hepatitis B vaccine
A Trial on Clinical Efficacy of 1% Versus 2% Lignocaine in Cough Suppression and Pain Relief in Patients Undergoing Flexible Bronchoscopy
Condition: Lung Cancer; Tuberculosis; Sarcoidosis; Interstitial Lung Disease
MeSH terms: Tuberculosis; Lung Diseases; Lung Diseases, Interstitial; Sarcoidosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Flexible bronchoscopy is a common procedure performed by pulmonary physicians. The use of
      topical anesthesia, analgesia, and sedation during flexible bronchoscopy varies among
      physicians, institutions and geographic locations across the globe. Commonly used topical
      anesthetic agents before and during bronchoscopy include cocaine (4%),benzocaine (20%),
      tetracaine (1%), and lignocaine (1%-10%). Topical lignocaine is administered through the
      flexible bronchoscope in an attempt to reduce excessive coughing and patient discomfort.
      However, the optimal dosage and strength of topical lignocaine that should be used during
      fibreoptic bronchoscopy has long been a topic of controversy. In this study we compare the
      efficacy of 1% versus 2% lignocaine in controlling cough and pain in patients undergoing
      flexible bronchoscopy.
    


Intervention name(s): 1% lignocaine; 2% lignocaine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: bronchoscopy; lignocaine; cough
Atomoxetine for the Treatment of Cannabis Dependence
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this small open-label trial is to evaluate the feasibility of recruiting
      cannabis dependent patients for treatment with Atomoxetine and MIT. The clinical data to date
      on Atomoxetine has been limited to children and adults with attention deficit disorder
      without co-morbid substance dependence. However, one study estimated that adults with
      attention deficit disorder have rates of drug abuse three to four times higher than controls
      (Mannuzza S 1998). The study also reported that cannabis and cocaine are most frequently
      abused in this population.
    

Detailed description: 
      This is a Phase 2 open-label study. We will recruit 10 cannabis dependent subjects and treat
      them with the combination of Atomoxetine and MIT to reduce their consumption of cannabis.
      Subjects will be 10 men and women with current DSM-IV diagnosis of cannabis dependence. All
      patients will receive Atomoxetine and four sessions of MIT. The study length for each patient
      will be one week for baseline screening and starting medication. This is followed by 8 weeks
      of medication and an end of study visit one week after completing medications.

      The PI will review all information collected regarding the subject's eligibility for the
      study. The subject will return approximately four days later, and if the PI finds the subject
      suitable for the study, the subject will begin taking study medication. This visit is
      referred to as visit 2. During visit 2, the PI will monitor the subject for concomitant
      medications and adverse events. The research technician will collect Vital Signs, Weight,
      BAL, the TLFB, a Urine Tox Screen and THC/CR ratio. Both visits 1 and 2 will be conducted
      within the first week of the study. Starting at visit 2, subjects will take one 25mg capsule
      of Atomoxetine orally for seven days. Beginning at visit 3, subjects will increase the dose
      to 40mg per day for 3 days, followed by 80mg (two 40mg capsules concurrently) for the other
      four days of the second week. Beginning with week 3, subjects will take two 40mg capsules
      (80mg total) every day of the week for 6 weeks.
    

Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atomoxetine; cannabis dependence; treatment