bioihbjkbjnl/mcl2 huggingface dataset:
Tau Imaging in Young Onset Dementia
Condition: Alzheimer's Disease, Early Onset; Logopenic Progressive Aphasia; Posterior Cortical Atrophy (PCA)
MeSH terms: Alzheimer Disease; Dementia; Aphasia
Study type: Observational

Summary: 
      The central goal of this study is to determine and compare the similarities and differences
      in regional brain uptake of [18F]T807 in patients with typical Alzheimer's Disease (AD),
      Posterior Cortical Atrophy (PCA), and Logopenic Variant of Primary Progressive Aphasia
      (lvPPA). The investigators will correlate patterns of [18F]T807 binding with magnetic
      resonance imaging (MRI)-based regional volumetric and cortical thickness measures. If
      cerebral spinal fluid (CSF) samples are not available, patients may be asked to get an
      optional lumbar puncture (LP) for additional comparisons. The investigators will recruit 20
      participants, 45-70 years old, with clinical evidence of young onset focal dementia.
    


Intervention name(s): [18F]-T807 imaging tracer
Intervention type(s): Drug
Intervention description(s): Tau Imaging tracer
Other intervention name(s): AV-1451
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with early onset AD (symptoms preceding age 65)
A Water-based Sequential Preparatory Approach and Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Many studies hypothesize that people who have suffered stroke could benefit from water-based
      exercises to improve their strength and ability to perform the activities of daily living.

      A Cochrane Review systematically synthesized and compared the effects of aquatic and
      land-based therapies on the activities of daily living (ADL) of patients following stroke and
      found that water-based exercises improved strength and ADL. A recent review indicates that
      RCTs comparing aquatic methods in both environments are lacking. The same movements in water
      and on dry land that target postural stability and gait require different competences. For
      example, the postural instability that occurs while squatting in water was enacted on land by
      sitting on a therapy ball. Furthermore, land-based conventional rehabilitation is generally
      task oriented, customized and challenging and follows a specific preparatory sequence of
      exercises according to patients' disabilities. Therefore, the investigators believe that a
      sequential preparatory approach (SPA), based on increasing difficulty and following a
      specific sequence of preparatory exercises (from the simplest to the most complex), should
      also be used in an aquatic environment.
    


Intervention name(s): Water-based Sequential Preparatory Approach
Intervention type(s): Other
Intervention description(s): The experimental training consists of a sequential and a preparatory approach aimed at enhancing dynamic postural stability. The exercises followed a specific sequence starting from a kneeling position, proceeding to a sitting position and ending with a supine position. Step exercises preparatory for gait were performed using a step and two floating aids. Gait exercises were performed first with the upper limbs placed on two floating aids and then during a dual motor task (i.e., catching a ball thrown by the therapist).
The control aquatic therapy consists of water-based exercises, in line with suggestions of the Hydrotherapy Association of Chartered Physiotherapists Guidance on Good Practice in Hydrotherapy.
These consisted of warm-up exercises, stretching exercises for the lower limbs, recruitment exercises and walking exercises during each phase of gait (single stance, swing and double stance).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Monocentric STUDY, Randomised Double Blinded (Healthy Subjects, or Transversal (Patients With Gitelman Syndrome)
Condition: Gitelman Syndrome; Potassium Depletion
MeSH terms: Gitelman Syndrome; Hypokalemia; Potassium Deficiency; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Progesterone is needed to permit adaptation of the kidney to limit potassium loss in the
      urines. The investigators wonder whether progesterone or other adrenal hormon play the same
      role. The investigators will investigate surrenal hormone production in healthy subjects
      under a 7-day potassium depleted diet and in patients chronically hypokalaemic due to a renal
      loss of potassium.
    

Detailed description: 
      The investigators will study the adaptation of steroidogenesis to potassium depletion in
      healthy volunteer, and the role of progesterone in renal adaptation to potassium depletion.
      Practically, healthy volunteers will be submitted twice to two periods of normal Na+/ high K+
      diet (control period) followed by a normal Na+/ low K+ diet sustained by a pharmacological
      treatment with Kayexalate (K+-depleted condition). The subjects will be treated with either
      RU486 or a placebo, according to a randomization. The adrenal response will be evaluated
      after stimulation by Synacthen at baseline and at the end of each experimental period. A
      Synacthen test will be also done in 10 patients suffering of chronic hypokalemia linked to a
      hereditary tubulopathy inducing renal K+ leak called Gitelman syndrome and their plasma
      steroid profile will be established.
    

Intervention name(s): Potassium depletion
Intervention type(s): Dietary Supplement
Intervention description(s): Healthy subjects will be submitted twice at 15-30 day interval, to a low potassium diet (20mmol/day)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Potassium intake; Progesterone; steroidogenesis; RU486; Synachtene test
A Study of JNJ-70033093 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) and relative
      bioavailability of a single dose of JNJ-70033093 spray dried dispersion (SDD) tablets
      compared with JNJ-70033093 SDD granule capsules in healthy participants under fasting
      conditions in Part 1 and 2 and to assess the effect of food on the bioavailability of a
      single dose of JNJ-70033093 SDD tablets in Part 1.
    


Intervention name(s): JNJ-70033093
Intervention type(s): Drug
Intervention description(s): JNJ-70033093 will be administered orally as per assigned treatment sequence.
Other intervention name(s): BMS-986177
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Measure Baricitinib (LY3009104) Absorption in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare how much baricitinib (study drug) gets into the blood
      stream when it is given as a single dose (in tablet form) and as an intravenous infusion
      (injection given directly into a vein via a small needle). Each participant in the study will
      make four visits to the investigator site over the course of about 6 weeks.
    


Intervention name(s): Baricitinib; [^13C4D3^15N]-baricitinib
Intervention type(s): Drug; Drug
Intervention description(s): 4 milligrams (mg) administered orally; 4 micrograms (μg) administered intravenously (IV)
Other intervention name(s): LY3009104; [^13C4D3^15N]-LY3009104
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Double-Blind Pharmacokinetic Interaction Study Evaluating the Effect of a Single IV Infusion of GGF2 or Placebo on Midazolam Pharmacokinetics in Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will examine midazolam pharmacokinetics following single dose administration of 3
      planned dose levels of GGF2 .
    

Detailed description: 
      This drug-drug interaction (DDI) study evaluates the potential effect of intravenously
      administered GGF2 on the elimination kinetics of midazolam.
    

Intervention name(s): Placebo; GGF2; Midazolam
Intervention type(s): Other; Drug; Drug
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intranasal Ketamine in Treatment-Resistant Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      The objective of the current study is to investigate the safety and efficacy of a single dose
      of intranasal (IN) ketamine in treatment-resistant depression (TRD).
    


Intervention name(s): Ketamine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of intranasal ketamine up to 50 mg; Single dose of saline intranasal
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ketamine; depression; treatment resistance; intranasal, antidepressant; glutamate; NMDA receptor
Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot study to determine the feasibility for a randomized controlled trial of two
      forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the
      Copper T 380A.
    

Detailed description: 
      Teenagers have the highest percentage of unintended pregnancies, and often struggle to comply
      with daily methods of contraception. The intrauterine device (IUD) provides safe, long-term
      protection and rates highly for patient satisfaction. It also does not require repeat
      prescriptions or clinic visits, making it a potentially attractive method among teens.
      However, in adolescent populations, there is both a lack of information about the IUD, as
      well as few studies that have examined the use of these devices. This study will examine
      whether a larger scale study on this topic is feasible. IT will address the feasibility of
      recruiting, consenting, screening, enrolling, randomizing, and retaining adolescents
      randomized to the LNG-IUS or Copper T 380a.
    

Intervention name(s): Levonorgestrel-releasing intrauterine device (LNG-IUS); Copper T380A intrauterine device (CuT380A)
Intervention type(s): Device; Device
Intervention description(s): Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.; Teens are randomly assigned to Copper T380 after the screening visit
Other intervention name(s): Mirena IUD; Paraguard IUD
Intervention MeSH terms: Copper; Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Intrauterine device, contraception, unplanned pregnancy
Deep Brain Stimulation in Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of deep brain stimulation surgery on
      movement-related cortical potentials in patients with Parkinson's disease.
    

Detailed description: 
      Patients who have had deep brain stimulation surgery for Parkinson's disease at Mayo Clinic
      Arizona will have electroencephalographic (EEG) measurements with the stimulator on followed
      by EEG measurements with the stimulator off. Patients who are scheduled to have deep brain
      stimulation surgery for Parkinson's disease will have EEG measurements before and after
      surgery.
    

Intervention name(s): Deep brain stimulation surgery.
Intervention type(s): Procedure
Intervention description(s): Deep brain stimulation surgery.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male
      subjects as well as to investigate pharmacokinetics, safety and tolerability
    


Intervention name(s): BI 1060469; BI 1060469; Other: standard breakfast
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h; tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration; tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
GSK239512 DDI Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will determine the effect of 400 mg once daily of ketoconazole at steady state on
      the pharmacokinetics of a single oral dose of GSK239512 in young healthy volunteers.
      Ketoconazole is a strong inhibitor of CYP3A4, which is involved in metabolism of drugs. A
      two-cohort design will be applied with cohort 1 aimed at providing a first estimate of the
      interaction potential of GSK239512 and ketoconazole in terms of pharmacokinetic parameters in
      a small number of subjects. Data from Cohort 1 will inform the decision of which dose to use
      in Cohort 2, in which a larger number of subjects will be exposed to GSK239512 without and
      with ketoconazole. The target maximum exposure is aimed to be similar to the exposure by a
      single dose of 80 mcg of GSK239512 without CYP3A4 inhibition. In summary, the results from
      this study will help to estimate the maximum increase in exposure of GSK239512 during
      concomitant use of strong CYP3A4 inhibitors and will help define the subsequent dosing
      strategy around GSK239512 and co-medications with potential to inhibit CYP3A4.
    


Intervention name(s): GSK239512; ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): H3 receptor antagonist, potential victim of drug-drug interaction; CYP3A4 inhibitor, potential perpetrator of drug-drug interaction
Intervention MeSH terms: Ketoconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: GSK239512; H3 receptor antagonist; drug-drug interaction; pharmacokinetics; ketoconazole
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound
      SPARC1316 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the
      safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending
      doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.
    


Intervention name(s): SPARC1316 Dose 1; Placebo; SPARC1316 Dose 2; SPARC1316 Dose 3; SPARC1316 Dose 4; SPARC1316 Dose 5
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): The subjects will receive SPARC1316.
Other intervention name(s): The subjects will receive a matching placebo by oral inhalation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacokinetics, pharmacodynamics, asthma
Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in
      multiple ascending doses in subjects with stable schizophrenia.
    

Detailed description: 
      This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242
      compared to placebo over 14 days twice a day dosing in multiple ascending doses in subjects
      with stable schizophrenia.

      This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to
      Biogen.
    

Intervention name(s): PF-04958242; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Administered as specified in the treatment arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple ascending doses; safety; tolerability; pharmacokinetics; cognitive impairment associated with schizophrenia (CIAS)
Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This trial aims to compare transtympanic steroids against the standard treatment
      (transtympanic gentamicin) in refractory unilateral Meniere's disease.
    

Detailed description: 
      Meniere's disease is characterised by episodic spontaneous vertigo attacks with hearing loss,
      ringing sounds and fullness in the ear. In one out of five patients, standard first line
      medical treatment is not effective in controlling vertigo attacks. For these incapacitated
      patients, gentamicin injections through the ear drum is a well established minimally invasive
      treatment. Major surgery of the balance organs or nerve, risking complete hearing loss, CSF
      leak, meningeal infections, are rarely performed nowadays. Gentamicn is very effective in
      controlling vertigo and acts by chemical ablation of end organs. As hearing and balance
      organs are entwined around each other, gentamicin treatment does not come without the risk of
      hearing loss. In fact, meta-analysis shows hearing deterioration in 13% to 35% percent of
      gentamicin treated patients. On the other hand, steroids are drug of choice for autoimmune
      inner ear disease and commonly used for sudden hearing loss. They are non toxic drugs without
      any known side effects during local treatment in ear. We will compare the two in this
      randomised, double blind trial.
    

Intervention name(s): Methylprednisolone; Gentamicin
Intervention type(s): Drug; Drug
Intervention description(s): 2 transtympanic injections at interval of two weeks.; 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
Intervention MeSH terms: Gentamicins; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meniere's disease; transtympanic steroids; Randomised controlled trial
Study on Infectious Mononucleosis in Munich
Condition: Infectious Mononucleosis; Epstein-Barr Virus Infections
MeSH terms: Communicable Diseases; Infections; Epstein-Barr Virus Infections; Infectious Mononucleosis
Study type: Observational

Summary: 
      This observational clinical study aims at the identification of novel biomarkers and
      causative factors of complicated and/or protracted Epstein-Barr virus-associated infectious
      mononucleosis (IM).

      Clinical, biochemical, and routine virological data were collected from 200 patients with IM,
      novel analytical tools were implemented, and immunological and virological experimental data
      were generated using blood samples and mouthwashes. Patients have been investigated within
      four weeks after the onset of symptoms as well as one month and six months thereafter.
    

Detailed description: 
      EBV-associated diseases are a severe and global health problem, and novel tools and targets
      for a better pathogenetic understanding, diagnosis, treatment, and prevention are clearly
      needed. Here we propose to use several novel experimental approaches to investigate
      immunological, virological, biochemical, and clinical features in an observational study on
      Munich IM patients.

      This study aims at identifying biomarkers and causative factors of protracted and/or
      complicated IM to facilitate the development of novel approaches to early diagnosis, therapy,
      and prevention of severe, life-threatening, and chronic EBV-associated diseases, including
      post-viral syndromes.

      Two hundred patients with IM onset within the last four weeks were recruited from Munich
      health care institutions and were re-investigated at one and six months after the onset of
      symptoms. A novel diagnostic scoring system was developed to indicate the severity,
      complexity, and protraction of symptoms.

      Investigated clinical parameters, including reported symptoms and physical signs of IM, as
      well as candidate risk factors in the medical history of patients and family members.
      Peripheral blood was analysed by established and novel analytical assays to determine the
      immunological and virological phenotypes of IM, and viral load was determined in mouthwashes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        200 patients with infectious mononucleosis.
      
Biospecimen description: 
      Blood, mouthwashes
    
Keywords: EBV; Pfeiffer's glandular fever; Post-viral syndrome
Remifentanil in Deep vs Moderate Neuromuscular Blocks During Surgical Pleth Index-guided Anesthesia for Laparoscopic Herniorrhaphy
Condition: Hernia Abdominal Wall
MeSH terms: Hernia, Ventral
Study type: Interventional

Summary: 
      The primary purpose of this study is to compare the remifentanil requirements in deep versus
      moderate neuromuscular blocks during the surgical pleth index -guided anesthesia in patients
      undergoing laparoscopic herniorrhaphy.
    


Intervention name(s): Moderate neuromuscular block; Deep neuromuscular block
Intervention type(s): Drug; Drug
Intervention description(s): maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg; maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention