bioihbjkbjnl/mcl2 huggingface dataset:
Caregiver Assisted Oral Hygiene for Individuals With Disabilities: Initial Safety
Condition: Oral Hygiene
Study type: Interventional

Summary: 
      The Enable Oral Hygiene System (EOHS) is a manual toothbrush comprised of a handle and shaft
      with multiple surfaces of synthetic bristles extending off of the shaft at one end. EOHS is
      intended for a caregiver to use to remove adherent plaque and food debris from the teeth of a
      consumer to reduce tooth decay. Caregiver Assisted Oral Hygiene for Individuals With
      Disabilities: Initial Safety is a first-in-human-use single arm clinical study to evaluate
      the safety of EOHS. This study has been designed to assess the safety of the device during
      self-brushing. The primary objective of the study is to evaluate the safety of the EOHS with
      able-bodied individuals during self-brushing. The primary endpoint for safety is 28 days. The
      primary endpoint of the study will be met if there are no device failures and no Adverse
      Device Effects (ADEs). Subjective assessment of cleaning using the EHOS during self-brushing
      will also be evaluated. A total of up to 12 subjects will be enrolled in the study.
    

Detailed description: 
      Twelve subjects will be recruited to evaluate the Enable Oral Hygiene System (EOHS) for
      safety. Subjects will be asked to complete demographic information and a medical history. An
      oral exam, including evaluation of oral cavity, soft and hard tissues, will be completed
      following standard of care procedures. Inclusion/exclusion criteria will be evaluated and
      eligibility for the study will be determined. Subjects who qualify for participation in the
      study will receive an EOHS toothbrush with the instructions for use accompanied within the
      product package. Subjects will then watch an instructional video demonstrating the use of the
      novel toothbrush. For 28 days, subjects will use the EOHS during normal (self) brushing twice
      daily. Subjects will be asked to record daily impressions of comfort, ease of use, and
      perceived cleanliness. At the conclusion of the study, subjects will record overall
      subjective impressions of comfort, ease of use, and perceived cleanliness. Any device related
      failures, adverse events, or safety concerns will be recorded. After 28 days, an oral exam,
      including evaluation of oral cavity, soft and hard tissues, will be completed following
      standard of care procedures. Subjects will be asked to return daily and overall impression
      documents as well as the EOHS.
    

Intervention name(s): Enable Oral Hygiene System (EOHS)
Intervention type(s): Device
Intervention description(s): The Enable Oral Hygiene System (EOHS) is a manual toothbrush comprised of a handle and shaft with multiple surfaces of synthetic bristles extending off of the shaft at one end.
Intervention model: Single Group Assignment
Intervention model description: First-in-human-use single arm clinical study to evaluate safety.
Masking: None (Open Label)
Primary purpose: Other
A Study of TAK-951 in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of TAK-951 for people with symptoms of nausea and vomiting. The main aims of
      this study in healthy adults are as follows:

        -  To check for side effects from TAK-951 when given at a slow and fast infusion rate.

        -  To learn how much TAK-951 participants can receive without getting side effects from it.

        -  To check how much TAK-951 stays in the blood over time to work out the best dose.

      Participants will receive a single infusion of either TAK-951 or placebo. In this study, a
      placebo looks like TAK-951 but does not have any medicine in it. Participants will receive
      either a low dose or high dose of TAK-951. The infusion will take from 1-3 hours.

      Participants will stay in the study clinic for about 4 days to receive the study medicine
      (TAK-951 or placebo) and check for side effects. They will have follow-up visits at the
      clinic about 2 weeks and 4 weeks after treatment.
    

Detailed description: 
      The drug being tested in this study is called TAK-951. The study evaluated the safety,
      tolerability and pharmacokinetics (PK) of TAK-951 in healthy participants.

      The study enrolled 128 healthy participants and consisted of 2 parts: Single-rising Dose
      (SRD) part (13 cohorts) of sequential panel design, and Multiple-rising Dose (MRD) part (5
      cohorts) of sequential panel design. Participants in each cohort were randomized to receive
      treatment with TAK-951 or matching placebo using SC injection, once daily on Day 1 (for SRD
      part) and twice daily (BID) on Days 1 through 5 (for MRD part) following a minimum fast of 8
      hours.

      This single center trial was conducted in the United States. The overall time to participate
      in this study was approximately 155 days.
    

Intervention name(s): TAK-951 Placebo; TAK-951
Intervention type(s): Drug; Drug
Intervention description(s): TAK-951 placebo-matching SC injection; TAK-951 SC injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Drug Therapy
The Effect of D3 on Selected Cytokines Involved in Cytokine Storm in the Covid-19 Uninfected Jordanian People
Condition: Cytokine Storm
MeSH terms: Cytokine Release Syndrome
Study type: Interventional

Summary: 
      The effect of Weekly 50,000 IU vitamin D3 supplements on the serum levels of selected
      cytokines involved in cytokine storm of Covid-19; A randomized clinical trial in the Covid-19
      uninfected people with vitamin D deficiency.
    

Detailed description: 
      No data are available on the effect of Weekly 50,000 IU vitamin D3 supplements on the serum
      levels of selected cytokines involved in cytokine storm of Covid-19 in the Covid-19
      uninfected Jordanian people with vitamin D deficiency. This study was designed to investigate
      whether a high dose of vitamin D3 (50,000 IU) / week for 8 weeks supplementation has a
      potential effect on cytokine storm of Covid-19; such as IL-1 beta, IL-6, and TNF in the
      Covid-19 uninfected Jordanian people with vitamin D deficiency.

      This study aims to assess whether high doses of vitamin D3 may improve immune responses
      against COVID-19 infection in uninfected Jordanian peoples. We hypothesize that Weekly 50,000
      IU vitamin D3 supplements will significantly change immune responses compared with the
      control group.
    

Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Covid -19; uninfected; IL-1; IL-6; TNF; VDD; Vitamin D3; 50,000IU
Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate
      (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar
      disorder or symptoms of mania.
    

Detailed description: 
      Patients are randomly assigned to receive lithium (Eskalith), valproate (Depakote), or
      risperidone (Risperdal) for 8 to 16 weeks. They will have weekly visits to monitor their
      response to the medication. When the study is complete, care will be transferred to the
      child's treating psychiatrist.
    

Intervention name(s): Lithium carbonate; Valproate; Risperidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Titrated until blood level is 1.1 to 1.3 mEq/L; Titrated until blood level is 111 to 125 ug/mL; Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID
Other intervention name(s): Depakote; Risperdal
Intervention MeSH terms: Valproic Acid; Risperidone; Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mania
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Subjects
Condition: Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Non-alcoholic fatty
      liver disease (NAFLD) treatment drug HEC96719 in Healthy Male and Female Subjects
    

Detailed description: 
      This study consists of a single-dose study and a multiple-dose study, both using a
      single-center, randomized, double-blind, placebo-controlled, dose-escalation design： I.
      Single-Dose Study There will be a total of 6 dose cohorts. Each cohort will include 10
      subjects, of which 8 receives HEC96719 tablets and 2 receives placebo, regardless of gender.
      Each subject will only participate in one dose cohort. Each cohort will be divided into 2
      group. The first group consists of 2 sentinels, one receiving active and one placebo. The
      second group will consist of the remainder of the cohort (7 active and 1 placebo) and,
      following review of the available safety data, will be dosed 48 hours after the sentinel
      group. Subjects can leave the pharmacy after their biological samples are collected on day 3.
      The last safety follow-up visit is to be performed on day 7±1 via telephone. Subjects in each
      cohort will receive a single dose of HEC96719 or placebo in the fasted state on day 1, and
      safety evaluation is to be performed on day 3 and 7.

      II. Multi-Dose Study There will be a total of 3 dose cohorts. Each cohort will consist of 12
      subjects, of which 10 receive HEC96719 tablets and 2 receive placebo, the dose regimen will
      comprise no less than once a day and will not exceed 4 times daily dosing for 7 consecutive
      days (study doses, administration method (fasted or fed), dosing frequency, and dosing period
      are all to be determined based on data from the single-dose study and multiple-dose study).
      Each subject will only participate in one dose cohort. Subjects will reside at the pharmacy
      from the day before dosing (D-1) to 96 h after the last dose. Subjects can leave pharmacy
      after their biological samples are collected. The last safety follow-up visit is to be
      performed 168±24 h after the last dose via telephone.
    

Intervention name(s): HEC96719
Intervention type(s): Drug
Intervention description(s): single-Dose Study: Each dose of HEC96719 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and multiple-dose study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Functional DN for Shortened HS Muscle
Condition: Hamstring Contractures
MeSH terms: Contracture
Study type: Interventional

Summary: 
      The aim of this study is to find whether functional dry needle is helpful to increase the
      length of shortened hamstring muscle or not
    

Detailed description: 
      Single pretest-post clinical trial to find immediate effects of functional dry needling to
      increase the length of the shortened hamstring. This study will be carried on single group
      which will include male subjects only. The data will be recorded before and immediately after
      the treatment. A monofilament stainless steel needle will be inserted on three points on
      hamstring muscle which will include semitendinosus, semimembranosus and bicep femoris.
      Treatment session will consist of 1 minute 20 seconds for each point on the hamstring and the
      manipulation will be performed by "Pistoning technique" in which the needle will be drawn out
      (not fully out of skin) after inserted and then again pushed in and data will be recorded
      after the treatment session on the basis of increase in length of hamstring which will be
      measure through 90-90 SLR (AKE) and on the lower extremity functional scale (LEFS)
    

Intervention name(s): Functional dry needling
Intervention type(s): Other
Intervention description(s): functional dry needling applied to hamstring for 1 minute and post interventional data collected
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dry needling; LEFS; 90-90 SLR
A Study to Evaluate ACT-132577 in Healthy Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to investigate the rate and routes (urine and feces) of
      elimination of ACT-132577, and the mass balance in urine and feces
    


Intervention name(s): 14C-radiolabeled ACT-132577
Intervention type(s): Drug
Intervention description(s): Single oral dose of 3.7 megabecquerel (MBq) (100 microcurie [μCi]) 14C-radiolabeled ACT-132577 administered as 1 capsule of 25 mg
Other intervention name(s): Aprocitentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate
Condition: REM Sleep Behavior Disorder; Parkinson Disease
MeSH terms: Parkinson Disease; REM Sleep Behavior Disorder; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is the first clinical trial using sodium oxybate for the treatment of REM sleep
      behavior disorder (RBD). Sodium oxybate is a drug approved by FDA for the treatment of
      narcolepsy which has been used "off label" to treat patients with severe RBD. This drug has
      shown to be effective and well tolerated in patients with RBD (Shneerson, 2009; Liebenthal,
      2016; Moghadam, 2017).
    

Detailed description: 
      Rapid eye movement sleep behavior disorder (RBD) is a condition resulting in violent
      dream-enactment during sleep which affects millions of individuals in the United States,
      however therapies for RBD are limited and cause significant side effects. As a result,
      despite using a combination of drugs, a large number of patients with RBD continue to act out
      violent dreams causing severe self-injuries or injuries to their bed partners. Prior studies
      and our experience have shown that sodium oxybate can be effective in these cases of
      treatment-resistant RBD. This study would therefore evaluate the efficacy and tolerance of
      sodium oxybate in this patient population.

      This study is an 8-week trial comparing sodium oxybate versus placebo randomly assigned to
      patients with treatment-resistant RBD, i.e. individuals who have insufficiently responded or
      tolerated melatonin and clonazepam. The study uses a double-blind design (participants,
      staff, and investigators will not know which drug between active drug and placebo is given to
      participants), and will measure treatment efficacy based on patients, partners and clinicians
      report, and objective outcomes based on in-home actigraphy and in-lab polysomnography before
      and after intervention.
    

Intervention name(s): Sodium Oxybate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Sodium Oxybate will be titrated up weekly by 1.5g nightly dose increments from an initial 4.5g total nightly dose (which could be given in two unequal doses if needed, or one single dose no greater than 4.5g) to an optimal individual dose based on clinical response on RBD symptoms and tolerance, to a maximum nightly dose of 9g ("flexible dose" period lasting up to 8 weeks). The optimal dose will then be continued for at least 4 weeks ("stable dose").; Placebo will be similar in appearance, smell and flavor to the subjects, so that the investigators and participants will be unable to distinguish it from sodium oxybate.
Intervention MeSH terms: Sodium Oxybate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sodium oxybate
Levoﬂoxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection
Condition: Cure Rate of Helicobacter Pylori Infection
MeSH terms: Infections; Helicobacter Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      To test the efﬁcacy of 14 day levoﬂoxacin and bismuth-containing second-line therapy for
      resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.
    


Intervention name(s): Proton pump inhibitor; Bismuth subsalicylate; Metronidazole; Tetracycline; Amoxicillin; Levofloxacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): antibiotic; antibiotic; antibiotic; antibiotic
Intervention MeSH terms: Amoxicillin; Metronidazole; Levofloxacin; Tetracycline; Bismuth; Bismuth subsalicylate; Proton Pump Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; second line treatment
Muscle Training Induced Angiogenesis in COPD
Condition: Peripheral Muscle Dysfunction; COPD
Study type: Interventional

Summary: 
      COPD patients experiment a peripheral muscle dysfunction which impact their exercise
      tolerance and health-related quality of life. The capillary to fiber interface is reduced and
      impact the exercise capacity of the patients. While the muscle capillary creation in response
      to exercise training is blunted in COPD patients, the maturation of the neo-capillaries could
      also be blunted and contribute to the impaired aniogionenesis in patients. Because the
      capillary maturation is a sensitive and dynamic process, only different modalities of
      exercise training and multiple time-points of measures would allow to capture this
      microvascular adaptation.

      Aim of the study : Compare the muscle capillary maturation in response to training at 5 and
      10 weeks, in sedentary healthy subject trained at the intensity of the ventilatory threshold
      (60-65% of VO2max), versus :- COPD patients trained at a similar intensity (60-65% of
      VO2max)- COPD patients trained at a similar absolute intensity (90% of VO2max).
    


Intervention name(s): Muscular biopsy; 5-10 weeks sport training
Intervention type(s): Procedure; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: COPD; skeletal muscle; angiogenesis; exercise training; intensity
Efficacy, Safety, & Tolerability of AZD3480 Patients With Mild to Moderate Dementia of the Alzheimer's Type (AD)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      Alzheimer's disease is the most common form of dementia and is the fourth leading cause of
      death among people 65 years of age and older. The global prevalence of the disease will
      increase significantly as the population ages, unless preventative treatments can be
      identified and marketed. The present study seeks to evaluate AZD3480 (TC-1734) compared to an
      approved medication (donepezil) shown to improve cognition and function in patients with
      Alzheimer's disease.
    

Detailed description: 
      This is a double blind, positive comparator, randomized, multicenter, parallel group study to
      assess the efficacy, safety, and tolerability of AZD3480 as monotherapy in patients with mild
      to moderate dementia of the Alzheimer's type (AD). Approximately 300 subjects will be
      randomized and divided into 2 cohorts. Actual randomization was 293 subjects.
    

Intervention name(s): Donepezil; AZD3480
Intervention type(s): Drug; Drug
Intervention description(s): Subjects taking donepezil will take 1-2 capsules of 5 mg donepezil and a placebo for AZD3480 (to maintain blind) orally once a day.; Subjects taking 30 mg AZD3480 will take one capsule of AZD3480 and two capsules of placebo for donepezil (to maintain blind) orally once a day.
Other intervention name(s): Aricept; TC-1734
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; AD; Dementia
Metabolism and Pharmacokinetics of [14C]-BI 409306 After Administration as Oral Solution in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to assess the mass balance recovery from excreta of carbon 14
      labelled BI409306 ([14C] BI 409306) in healthy, CYP2C19 genotyped subjects and to provide
      plasma, urine and faecal samples for metabolite profiling and structural identification.
    


Intervention name(s): 14C-BI 409306
Intervention type(s): Drug
Other intervention name(s): 14C-BI 409306 oral solution
Intervention MeSH terms: BI 409306
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Safety and How the Body Effects a Drug CNTO 136 in Healthy Male Japanese and Caucasian Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and how the body affects
      the drug CNTO 136 in healthy Japanese and Caucasian volunteers.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blinded study to assess the safety and
      pharmacokinetics of CNTO 136. In a randomized trial, study medication (CNTO 136 or placebo)
      is assigned by chance. Double-blinded means that neither the investigator nor the volunteer
      know which of the study medication they have been assigned to receive. Pharmacokinetics is
      the study of levels of CNTO 136 circulating in your blood over time. The study population
      will all be male and consist of 30 Japanese and 30 Caucasian volunteers. Three dose levels of
      study agent will be assessed. Participants will be required to stay at the research center
      after study agent administration for the inpatient portion of the study and then required to
      return for out-patient visits. One of 3 dose levels of CNTO 136 will be given just under the
      skin (subcutaneous (SC)). The length of this study will be about 20 weeks.
    

Intervention name(s): CNTO 136
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: CNTO 136; safety; pharmacokinetics; healthy Japanese; healthy Caucasian; Phase I; antibody; male.