bioihbjkbjnl/mcl2 huggingface dataset:
Sensitivity of Project: EVO Monitor Cognitive Measurements to Pharmacological Agents
Condition: Healthy
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      This is a study in adults to assess the sensitivity of Project: EVO Monitor cognitive
      measurements to two short-acting cognitively active pharmacological agents. The participants
      will receive a placebo, and two pharmacological agents in a randomized order for three
      in-clinic study days. During each study day in the clinic, the participants will use Project:
      EVO Monitor and another cognitive task through the day.
    

Detailed description: 
      This is a study in adults ages 40 to 55 to assess the sensitivity of Project: EVO Monitor
      cognitive measurements to two short-acting cognitively active pharmacological agents,
      methylphenidate (MPH) and triazolam (TRZ). The participants will receive a placebo, MPH, and
      TRZ in a randomized order for three in-clinic study days. All drug administration and
      cognitive testing will take place in the clinic under medical staff supervision. During each
      study day in the clinic, the participants will use Project: EVO Monitor and do a short digit
      symbol substitution task (DSST) 8 times over the day. A minimum of 48 hours will be needed
      between each study day. The investigators plan to evaluate 18 participants in this study.
    

Intervention name(s): Methylphenidate; Triazolam; Project: EVO; Placebo
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control. Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.; Triazolam is a benzodiazepine similar to Valium. Triazolam affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia). Triazolam is used to treat insomnia (trouble falling or staying asleep).; Project: EVO Monitor was designed to incorporate a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.; Sugar pill
Other intervention name(s): Ritalin; Halcion; Cognitive Monitor; Sugar Pill
Intervention MeSH terms: Triazolam; Methylphenidate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
A Safety, Tolerability and Pharmacokinetic Study of CPP-115
Condition: Cocaine Dependency
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      • To evaluate the safety and tolerability of ascending single oral doses of CPP-115

      Secondary Objective:

      • To determine the pharmacokinetic profiles of CPP-115 following administration of a
      ascending single oral doses
    


Intervention name(s): CPP-115; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.; An equal volume of water mixed with juice will be administered.
Other intervention name(s): CPP-115
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety; Tolerability
Bioavailability/Bioequivalence Study Between Lacosamide Tablet and Solution for Infusion in Healthy Japanese Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a
      single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral
      dose of LCM 200 mg in healthy Japanese subjects.
    


Intervention name(s): Lacosamide infusion; Lacosamide oral
Intervention type(s): Drug; Drug
Intervention description(s): Strength: 10 mg/mL for infusion
Form: solution for infusion
Dosage: 200 mg, single dose
Duration: 30-minute infusion or 60-minute infusion; Strength: 200 mg
Form: film-coated tablet
Dosage: 200 mg, single dose
Duration: single oral intake
Other intervention name(s): Vimpat; Vimpat
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Lacosamide; Vimpat; Bioequivalence; Bioavailability; Japanese
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
Condition: Hemiparesis; Stroke
MeSH terms: Stroke; Paresis
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether an existing treatment for problems that
      participants have with making movements after a stroke can be performed at home.
    

Detailed description: 
      This study will compare two forms of home-based treatment for post-stroke problems making
      movements with the arms and hands. After initial pre-treatment assessments, participants will
      complete 4 weeks of treatment, with assessments after each week of treatment and 3 months
      after the completion of treatment.
    

Intervention name(s): Mirror therapy; Divider therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A home-based therapy involving mirrored visual feedback; A home-based therapy involving removed visual feedback.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; hemiparesis; arm movement; sensory functioning
Evaluation of Balance and Trunk Muscle Endurance in Dancers
Condition: Balance; Distorted; Sports Injury
MeSH terms: Athletic Injuries
Study type: Interventional

Summary: 
      This study evaluates endurance of trunk muscles, balance and pulmonary functions in dancers.
      The participants will be evaluated trunk muscles endurance, pulmonary functions and balance
      which evaluated by computerized force plate system.
    

Detailed description: 
      Dance is a form of exercise associated with movements that require balance, flexibility,
      endurance and skill. In addition to maintaining balance, the endurance of the trunk
      stabilizer muscles has an important role in sport-specific activities, coordination and
      athletic performance. Studies which conducted on dancers are mainly focused on abdominal
      muscle strength / endurance, lower extremity strength and physical performance. In the
      literature, it was reported that 40-84% of professional dancers and 26-51% of professional
      dancers had musculoskeletal injuries, particularly lower extremity problems. It is very
      important to regain balance after returning to the dance after foot and ankle injuries.
      Considering the function of the trunk as a bridge between the lower and upper extremities, it
      is known that trunk muscles play a fundamental role in regaining balance. However, in the
      literature, there is no study showing the effects of trunk stabilizer muscles (abdominal,
      dorsal extensor, lateral flexor and diaphragm), trunk flexibility and dance-specific
      properties on balance in dancers. As a result of this study, it is aimed to show the effect
      of dance on balance and related parameters and to reveal the factors affecting the balance.
    

Intervention name(s): Balance analysis
Intervention type(s): Other
Intervention description(s): Balance analysis is assessment method to estimate deterioration of postural control.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Balance; Dancer; Respiratory muscle; Trunk muscle
Repeated Dosing Clinical Trial of HL151
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine
      after multiple oral administration of TALION tab., a IR formulation of bepotastine as
      reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male
      adults. Additionally the safety and tolerability of two drugs will be evaluated.
    


Intervention name(s): HL151; TALION tab.
Intervention type(s): Drug; Drug
Intervention description(s): Test drug : HL151. 1T, once a day oral administration, for 4 days; Reference drug : TALION tab. 1T, twice a day oral administration, for 4 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
Condition: Schizophrenia and Predominant Negative Symptoms
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical
      antipsychotic medication, on negative symptoms in adult subjects with clinically stable
      schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment
      of Negative Symptoms (SANS).
    


Intervention name(s): SPD489 (lisdexamfetamine dimesylate); Placebo matching SPD489 (lisdexamfetamine dimesylate)
Intervention type(s): Drug; Drug
Intervention description(s): oral, 20, 30, 40, 50, 60, or 70 mg once daily; oral, once daily
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia
the Prevalence of Oral Manifestation in Patients With SARS-CoV2 Infection
Condition: SARS-CoV2 Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Oral Manifestations
Study type: Observational

Summary: 
      The SARS-Cov2 virus was identified in china at the end of 2019 and spread worldwide causing a
      global pandemic. Current research showed that SARS-Cov2 virus invades human cells via the
      receptor angiotensin-converting enzyme 2 (ACE2) through scRNA-seq data analyses. The study
      identified the organs that are at risk and are vulnerable to SARS-CoV-2 infection. Therefore,
      cells with ACE2 receptor distribution may become host cells for the virus and cause
      inflammatory response in related organs and tissues, such as the tongue mucosa and salivary
      glands. These results suggest that oral mucosa could be a target of SARS-CoV-2 infection
    

Detailed description: 
      The oral cavity is particularly susceptible to viral infection with several viruses such as
      herpes simplex virus, cytomegalovirus and Zika virus because of its structures, especially
      salivary glands and soft tissues . Moreover, oral mucosa can be affected by secondary
      pathological process of a bacterial or fungal nature due to viral immunosuppression. The oral
      cavity could be considered a "biological barometer" of both viral infection and viral
      immunosuppression advancement .

      The SARS-Cov2 virus was identified in china at the end of 2019 and spread worldwide causing a
      global pandemic. Current research showed that SARS-Cov2 virus invades human cells via the
      receptor angiotensin-converting enzyme 2 (ACE2) through scRNA-seq data analyses. The study
      identified the organs that are at risk and are vulnerable to SARS-CoV-2 infection. Therefore,
      cells with ACE2 receptor distribution may become host cells for the virus and cause
      inflammatory response in related organs and tissues, such as the tongue mucosa and salivary
      glands. These results suggest that oral mucosa could be a target of SARS-CoV-2 infection .

      Although many authors reported the presence of oral lesion associated with SARS-CoV2
      infection, the prevalence of the oral manifestation and the range of oral manifestation are
      still unknown. Further studies are necessary to better understanding of the symptoms of the
      SARS-CoV2 virus in order to faster detection. A multidisciplinary team following the patients
      could be the key in treatment of the infection and faster recovery.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This is a multicenter cross- sectional study to study the prevalence of oral manifestation
        among patients with SARS-CoV2 infection and identify the range of the oral manifestation
        and site of lesions
      
Keywords: SARS-CoV2; Oral Manifestation; prevalence
A Drug-Drug Interaction Study Evaluating the Perpetrator Potential of DC-806 on Cocktails of CYP450 Enzyme and Transporter Substrates in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to assess the effect of DC-806 on the pharmacokinetics
      (PK) of cytochrome 3A4 (CYP3A4) substrate, midazolam and its active metabolite,
      1-hydroxymidazolam, cytochrome 2C8 (CYP2C8) substrate repaglinide, P-glycoprotein (P-gp)
      transporter substrate digoxin, and breast cancer resistant protein (BCRP)/ organic anion
      transporter protein-1B1 (OATP1B1) transporter substrate rosuvastatin in healthy participants.
    


Intervention name(s): DC-806; Midazolam; Repaglinide; Digoxin; Rosuvastatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral tablets; Oral syrup; Oral tablets; Oral tablets; Oral tablets
Intervention MeSH terms: Repaglinide; Digoxin; Midazolam; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: DC-806; Drug-drug interaction; Midazolam; Repaglinide; Digoxin; Rosuvastatin
A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the safety of upadacitinib combined with topical
      corticosteroids (TCS) in adolescent and adult participants in Japan with moderate to severe
      atopic dermatitis (AD) who are candidates for systemic therapy.
    


Intervention name(s): Upadacitinib; Placebo for upadacitinib; Topical Corticosteroids (TCS)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Upadacitinib is administered orally.; Placebo is administered orally.; It is administered concomitantly with upadacitinib or placebo.
Other intervention name(s): ABT-494
Intervention MeSH terms: Upadacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Upadacitinib; Topical Corticosteroids; Atopic Dermatitis
Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA
Condition: OSA; Apoplexy
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Apoplexy patients with OSA are often not receiving a CPAP therapy due to generally poor
      acceptance and adherence. There is a great potential to significantly improve the treatment
      and care of these patients in a time economic way by telemonitoring the therapy in home
      environment.

      This study is planned to prove that telephone consultancy and motivation in times of recorded
      decreasing CPAP therapy usage can improve adherence, neurological function and quality of
      life.
    

Detailed description: 
      Eligible patients with confirmed OSA from neurological rehab department of Helios Clinic
      Hagen Ambrock are asked to join the study. They will be randomly assigned to one of two arms
      [CPAP with Telemonitoring (MTM) or without Telemonitoring (OTM)] for 6 months of home
      treatment after hospital discharge. The MTM arm will receive supporting phone calls when the
      monitored usage time decreases.
    

Intervention name(s): CPAP therapy; Support
Intervention type(s): Device; Other
Other intervention name(s): ICON™; Motivation; Telemonitoring; Software Infosmart Web; GSM module
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OSA; Apoplexy; CPAP; adherence; telemonitoring
Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy
Condition: Therapeutic Hyperthermia; Thermotherapy; Polymers
MeSH terms: Hyperthermia; Fever
Study type: Interventional

Summary: 
      The objective of this work is to evaluate, from volunteers viewpoint, the usability, comfort,
      appearance, weight, superficial temperature, and other characteristics of a polymeric plate
      derived from castor oil developed to thermotherapy.

      The volunteers will use polymeric plate as a therapeutic resource in the shoulder area and
      then fill in, without interference of the researcher, some questions about the
      characteristics of interest.
    

Detailed description: 
      In this study, the polymeric plate is prepared using the following procedure:

        1. - the water is heated to the boiling temperature

        2. - the heater is shut down

        3. - the polymeric plate is immersed in water

        4. - it rests in the water for 15 minutes

        5. - it is inserted in a wrap

      In this condition, the polymeric plate is placed on the shoulder of the volunteer and remains
      there for 20 minutes.

      After application, the volunteer answers the questionnaire containing eight questions on a
      Likert scale (0 to 10) and an area of observations.

      Previous laboratory tests were performed to ensure that the temperature of the polymeric
      plate will not cause skin burn in this application condition.
    

Intervention name(s): Polymeric plate
Intervention type(s): Device
Intervention description(s): Application of the polymeric plate in the shoulder for 20 minutes after warming it for 15 minutes in hot water, initially at boiling temperature.
Other intervention name(s): PPDOM; PPDCO
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Therapeutic Hyperthermia; Thermotherapy; Polymers; Castor Oil
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ADC3680B in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a First-In-Man study designed to examine the safety, tolerability, pharmacokinetics
      and functional activity of ADC3680B after single and multiple doses in healthy male
      volunteers.
    


Intervention name(s): ADC3680B; ADC3680B; ADC3680B
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Escalating single doses ADC3680B or Placebo over 5 study periods; ADC3680B or Placebo for 7 days; Single doses ADC3680B over 2 study periods under fasted and fed conditions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Copenhagen Adductor Exercise Trial
Condition: Eccentric Hip Adduction Strength
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy of a 6-week intervention, using the
      Copenhagen adductor exercise, on adductor muscle strength in sub-elite male footballers.
      Secondly, it will also examine the effect of a 3-week detraining period, after stopping the
      Copenhagen adductor exercise, on adductor muscle strength.

      The primary outcome measure is eccentric hip adduction strength measured using a handheld
      dynamometer. Additionally, peak isometric adductor squeeze strength will also be measured
      using a handheld dynamometer.

      The hypothesis is that strength training of the adductor muscles elicited by the Copenhagen
      adductor exercise will result in enhanced eccentric hip adduction strength.
    


Intervention name(s): Copenhagen adductor exercise
Intervention type(s): Other
Intervention description(s): The active player is supported on one forearm on the floor and the upper arm is resting along their side. The supporting partner places their hands at the ankle and the knee of the upper leg. The active partner raises their body from the floor and adducts both legs in a three second movement until the body reaches a straight line. The body is then lowered to the ground in a three second movement, the foot of the lower leg touches the ground before performing another repetition.
Other intervention name(s): Adductor bridge exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Combined Cognitive and Functional Strength Training in Children With cp
Condition: Diplegic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy is primarily a disorder of movement and posture however; it often involves
      disorder of different aspects of cognitive function.
    

Detailed description: 
      This study evaluated the effect of FST and cognitive intervention and their combined effect
      on motor and cognitive functions in children with spastic diplegia. A convenient sample of
      spastic diplegic CP children, with their age ranging from 8 to 12 years were assigned
      randomly into four treatment groups
    

Intervention name(s): functional strength training; cognitive training; conventional physical therapy
Intervention type(s): Other; Other; Other
Intervention description(s): children in this group received FST. Each training session started with 10 minutes dynamic warm-up period and ended with 5 minutes cool down in the form of muscle stretching and aerobics. The warm up was followed by gait training in addition to 4 functional lower limb exercises; sit to stand exercise, forward/ lateral step-up exercise, half knee rise exercise, and bridging exercise.; Children in this group received cognitive training by RehaCom cognitive rehabilitation software. Training was applied for four cognitive domains of function; attention / concentration, figural memory, reaction behavior and logical reasoning.; including reinforcement of normal motor development, reflex inhibiting patterns, balance exercises, stretching exercises and gait training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment