bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of mGlu5 NAM HTL0014242
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first time HTL0014242 will be administered to humans. The principal aim of this
      study is to obtain safety and tolerability data when HTL0014242 is administered orally as
      single doses to healthy subjects. This information, together with the pharmacokinetics data,
      will help establish the doses and dosing regimen suitable for future studies in patients
    

Detailed description: 
      This study will comprise a single dose, sequential group design. Overall, up to 72 subjects
      will be studied in up to 9 planned groups (Groups 1 to 9), with each group consisting of 8
      subjects. In addition, a further 6 subjects will participate in a crossover food effect arm.

      Subjects will be screened within 28 days prior to dosing. Each subject will participate in 1
      treatment period only, except the food effect arm where subjects will be dosed both fed and
      fasted. Subjects will reside at the clinical research unit from Day -1 (the day before
      dosing) to Day 5.

      All subjects will return for a follow-up visit 7 to 14 days after dosing. The investigator
      (or designee) may also request that the subject return for an additional follow up visit.

      In each of groups 1 to 9, 6 subjects will receive a single dose of HTL0014242 and 2 subjects
      will receive placebo oral capsule in accordance with a randomisation schedule. In the food
      effect arm, 6 subjects will receive a single dose of HTL0014242 in both the fed and fasted
      state, separated by 14 days.
    

Intervention name(s): HTL0014242; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): HTL0014242 is a selective negative allosteric modulator (NAM) for the metabotropic glutamate (mGlu) receptor 5 subtype (mGlu5); Placebo treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single ascending dose
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Arthroscopic Treatment of Bursal-side Rotator Cuff Tears in Shoulder Joint
Condition: Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      A retrospective analysis was performed on patients with bursal-side partial-thickness rotator
      cuff tears who underwent arthroscopic surgery from January 2009 to December 2011. To
      investigate the diagnosis and arthroscopic treatment of partial rotator cuff bursa lateral
      tear, and to evaluate the postoperative functional outcome and tendon healing.
    

Detailed description: 
      To study the surgical method and clinical effect of arthroscopic treatment for partial tear
      of rotator cuff bursa. A retrospective analysis was performed on patients bursal-side
      partial-thickness rotator cuff tears who underwent arthroscopic surgery from January 2009 to
      December 2011. Preoperative X-ray and MRI were performed. Rotator cuff repair was performed
      during the operation. UCLA shoulder scoring scale was used to evaluate the joint at
      preoperative and final follow-up.
    

Intervention name(s): shoulder arthroscopy
Intervention type(s): Procedure
Intervention description(s): Patients underwent ubacromial bursectomy and acromioplasty , cuff debridement and cuff repair, side to side suture of rotator cuff combined with suture anchor.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with bursal-side partial-thickness rotator cuff tears, there has been
        very little research on bursal-side partial-thickness rotator cuff tears, which has no
        consensus on diagnosis and treatment.
Effects of Lacosamide on Human Motor Cortex Excitability: a Transcranial Magnetic Stimulation Study
Condition: Healthy Male Volunteers
Study type: Interventional

Summary: 
      This study has been designed to explore dose-depended effects of lacosamide (LCM) on motor
      cortex excitability with TMS in a randomized, double-blind, placebo-controlled crossover
      trial in young healthy human subjects, and to compare the pattern of excitability changes
      induced by LCM with those of carbamazepine (CBZ). LCM selectively enhances slow inactivation
      of voltage-gated sodium channel, and, in contrast to CBZ, does not affect steady-state fast
      inactivation (Errington et al., 2006). The enhancement of slow inactivation of sodium
      channels by LCM is a novel manner to modulate sodium channels and leads to normalization of
      activation thresholds and a reduced pathophysiological hyper-responsiveness, thereby
      effectively controlling neuronal hyperexcitability without affecting physiological activity
      (Beyreuther et al., 2007). Therefore, it is thought that LCM, compared to CBZ, will be better
      tolerated in clinical settings while being as or even more effective in controlling seizure
      activity. On the basis of the results from nonhuman studies, it is hypothesized that the TMS
      profile of LCM will be distinguishable from that of CBZ. CBZ, like other 'classical' sodium
      channel blockers such as phenytoin, predominantly demonstrated elevated TMS motor thresholds
      indicating reduced neuronal membrane excitability, without developing significant changes of
      synaptic intracortical inhibition and facilitation (Ziemann et al., 1996; Chen et al., 1997;
      Lee et al., 2005). Because of its novel mode of action it can only be speculated which TMS
      parameters LCM might affect. For example, more than exclusively affecting neuronal membrane
      excitability, LCM could possibly also affect inhibitory mechanisms such as short- and
      long-latency intracortical inhibition (Valls-Sole et al., 1992; Kujirai et al., 1993). This
      would in line with other well-tolerated modern antiepileptic drugs (Ziemann et al., 1996;
      Reis et al., 2002; Lang et al., 2006).
    


Intervention name(s): Lacosamide; Placebo; Carbamazepine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lacosamide 200 or 400 mg; Placebo; Carbamazepine 600 mg
Intervention MeSH terms: Lacosamide; Carbamazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: lacosamide; carbamazepine; placebo; transcranial magnetic stimulation; TMS; motor cortex; sodium channel; inhibition; threshold
SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems.
    

Detailed description: 
      Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems
      during motion and non-motion.
    

Intervention name(s): Pulse oximeter
Intervention type(s): Device
Intervention description(s): Hypoxia
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
The Effect of Oats Containing 1.4g Beta Glucan on Fecal Bacterial Population(s) and Plasma Cholesterol in Healthy Adults With Elevated Cholesterol Levels
Condition: Microbiome; Plasma Cholesterol; Prebiotic
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The objectives of this study are to examine fecal bacterial population(s) and plasma
      cholesterol levels elicited by 40g of Oats and Cream of Rice over 6 weeks.
    


Intervention name(s): Hot Cereal
Intervention type(s): Other
Intervention description(s): Intervention involves consumption of one hot cereal in the beginning of each day
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: For each of the two periods, a hot breakfast cereal will be consumed once daily for a duration of 6 weeks each. There will be a 4 week washout period in between each test substance.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Role of Protein in Regulating Ad Libitum Energy Intake in Humans
Condition: Energy Balance
Study type: Interventional

Summary: 
      The purpose of this project is to determine if protein is less likely to create positive
      energy balance when added to the diet compared to carbohydrate. To do this, the investigators
      will take detailed measurements of participant's baseline metabolic rate to understand their
      energy requirements. Then, the investigators will feed participants all their meals for two
      weeks, Monday-Friday, and measure their food intake. During one of the week-long feeding
      periods, participants will consume a shake made of egg protein that is ~20% of their energy
      requirements. During the other week, participants will consume a shake made of carbohydrate
      that is ~20% of their energy requirements. Participants will drink the assigned shake at the
      beginning of each of their daily three meals, and then they will be offered a 'regular' meal
      of unlimited quantity. Participants will not know that the investigators are measuring the
      food consumed after drinking the shake. Participants will drink the protein shake for the
      first week and carb-based shake for the second week, and vice versa-- depending on the
      randomization order. To account for energy expenditure, participants will wear an activity
      monitor, an accelerometer. Energy balance, measured as participant energy intake minus energy
      expenditure, will be our main outcome for each treatment. However, because participants may
      change their behavior if made aware of the true research question, the investigators will
      tell participants that the purpose of the study is to see how low fiber and high fiber shakes
      affect mood. The hypothesis is that during the week when participants consume the protein
      shake, they will remain in energy balance, but during the week of carbohydrate shake
      consumption, participants will have positive energy balance.
    


Intervention name(s): Consumption of NOW Foods eggwhite protein shake; Consumption of NOW Foods maltodextrin shake
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of NOW Foods egg white protein shake at beginning of 3 daily meals that in total, is approximately 20% of caloric needs.; Consumption of NOW Foods maltodextrin shake at beginning of 3 daily meals that in total, is approximately 20% of caloric needs.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ad libitum; Energy balance; Protein
Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network
Condition: Cardiovascular Diseases; Heart Diseases; Infection; Coronary Aneurysm
MeSH terms: Cardiovascular Diseases; Heart Diseases; Aneurysm; Mucocutaneous Lymph Node Syndrome; Coronary Aneurysm
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary endpoint is coronary artery diameter, normalized for body surface area, 5 weeks
      after randomization. Secondary endpoints include duration of fever, CRP levels, and adverse
      events.
    

Detailed description: 
      BACKGROUND:

      Kawasaki Disease (KD) is an inflammatory vasculitis of unknown etiology that affects infants
      and children and can cause coronary artery aneurysms. Standard therapy consists of 2 gm/kg of
      intravenous immune globulin plus high-dose aspirin in the acute phase, and low-dose aspirin
      in the convalescent phase. Some children do not respond to this therapy, and some children go
      on to develop coronary artery aneurysms in spite of aggressive treatment. This led to the
      design of this randomized controlled trial to compare a single dose of intravenous steroids
      vs. placebo on the background of standard therapy. Recruitment began in December, 2002 and
      ended in December, 2004 with nearly 200 patients randomized.

      DESIGN NARRATIVE:

      This is a randomized controlled trial to compare a single dose of intravenous steroids vs.
      placebo on the background of standard therapy
    

Intervention name(s): Steroids
Intervention type(s): Drug
Intervention description(s): This study evaluates the efficacy and safety of pulse steroid therapy, when added to conventional treatment with IVIG plus aspirin, in treatment of children with acute Kawasaki disease.
Other intervention name(s): pulse steroid therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Are novel vascular closure devices noninferior to manual compression regarding access site
      complications after coronary angiography?
    

Detailed description: 
      Vascular closure devices have been shown to be safe and effective in reducing the time to
      hemostasis and immobilization when compared to manual compression following coronary
      angiography. This effect is beneficial in patients presenting with chronic back pain,
      prostate enlargement, mental impairment or other disorders that preclude prolonged bed rest.

      However, adequately powered large scale randomized trials with vascular closure devices
      remain a gap in the scientific literature.

      This trial compares, in a randomised design two novel vascular closure devices (FemoSeal &
      ExoSeal) versus manual compression after coronary angiography. This study is aimed to
      investigate if novel vascular closure devices are noninferior to manual compression regarding
      access site complications.
    

Intervention name(s): FemoSeal®; ExoSeal®; Manual compression
Intervention type(s): Device; Device; Other
Intervention description(s): Closure device for femoral artery access closure; Closure device for femoral artery access closure; Conventional manual compression
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Closure Device; Coronary Angiography
Acupuncture for Dry Eye Syndrome
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is about the effectiveness of acupuncture treatment on dry eye syndrome. Study
      hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture
      in dry eye syndrome patients. This is a randomized, patients-assessor blinded, sham
      acupuncture controlled study. Additionally, the investigators will assess the safety of
      acupuncture treatment.
    


Intervention name(s): Standardized Acupuncture; Non-acupuncture point shallow penetration acupuncture
Intervention type(s): Device; Device
Intervention description(s): Acupuncture treatment will be applied 3 times per week, total 9 times for 3 weeks.
According to the guideline of WHO standard acupuncture point locations in the western pacific region, acupuncture treatment will be offered in all 17 acupoints: both BL2, GB14, TE23, Extra-1(Taiyang), ST1 and GB 20, and GV23, and Left SP3, LU9, LU10 and HT8, which are located in periorbit, forehead or temple of the head and Lt. forearm and back of the Lt. foot by a disposable 20*30mm (Dongbang Co., korea) acupuncture needle.
All the acupuncture needles will be inserted, induced strong 'deqi' sensation and retained for 20 minutes.; Acupuncture treatment will be applied 3 times per week, all 9 times for 3 weeks.
Acupuncture treatment will be offered in 17 non-acupuncture points by a disposable 20*30mm acupuncture needle. A strong 'deqi' sensation will not be induced, but inserted acupunctures will be leaved for 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Dry eye syndrome; Ocular Surface Disease Index; Schirmer test; Tear film Break-up time
Use of Red Cell Distribution Width for Prediction of New-onset Atrial Fibrillation in Critically Ill Sepsis Patients
Condition: Atrial Fibrillation New Onset
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Red cell distribution width variations are increased in a variety of medical conditions such
      as congestive heart failure, acute myocardial infarction, pulmonary embolism, pneumonia,
      critical illness, and cardiac arrest , and is a predictor of mortality in the general
      population..
    

Detailed description: 
      This study was done retrospectively on sepsis patients admitted to intensive care units. data
      will be retrieved from patient medical records. The primay end point will be occurrence of
      new-onset AF during ICU stay. The secondary outcomes will be 28-day mortality.

      The presence of anisocytosis or RDW variations has been classicaly used as a test for iron
      deficiency anemia. Increasing evidence points to its potential as a predictor for various
      conditions such as heart failure , malignancy, ischemic heart disease and sepsis.

      Study investigators will examine the relationship between RDW levels and incidence of atrial
      fibrillation in critically ill sepsis patients as well as 28-day mortality.
    

Intervention name(s): Red Cell Distribution Width
Intervention type(s): Diagnostic Test
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        70 patients of both sexes were enrolled in this study. They were admitted to the general
        ICU of Ain Shams University Hospitals with sepsis or septic shock
Continuous Glucose Monitoring and Metabolic Control in Children With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The primary purpose of this pilot randomized controlled trial is to provide preliminary
      indicators of the effects of continuous subcutaneous insulin infusion with continuous glucose
      monitoring compared to self-monitoring of blood glucose alone on: (1) metabolic control and
      (2) fear of hypoglycemia. Additional objectives will be: (1) to provide an estimate of
      recruitment rates, (2) to assess compliance with allocated treatment, and (3) to determine
      participants' satisfaction with allocated treatment.

      With increased and immediate information related to current and future (trend) glucose
      information provided by the continuous glucose monitor, children can then act upon this
      knowledge to prevent hypo- or hyperglycemia, thus, experiencing a reduction in glucose
      variability, leading to an improvement in metabolic control as shown by a reduction in HbA1c
      levels.

      Research on the effectiveness of continuous glucose monitoring on metabolic control in
      children with T1D using continuous subcutaneous insulin infusion has been limited. Therefore,
      a pilot clinical trial will be designed to provide preliminary indicators of the feasibility
      and acceptability of continuous glucose monitoring on metabolic control and address the
      following objectives.
    


Intervention name(s): Mini Link REAL-Time Transmitter
Intervention type(s): Device
Intervention description(s): Children used the Mini Link REAL-Time Transmitter to measure glucose continuously for a minimum of three days per week for three months.
Primary purpose: Treatment
Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-blinded, placebo- and active-controlled, parallel, single-ascending dose phase 1
      clinical trial to evaluate the safety and pharmacokinetics of DA-5207 transdermal delivery
      system in healthy adults
    


Intervention name(s): DA-5207; Donepezil Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): DA-5207 Transdermal Delivery System; donepezil HCl 10mg QD
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Research Study to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not Used Insulin Before
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine
      doctors can already prescribe) in people with type 2 diabetes. Different ways of changing the
      dose of insulin 287 are also compared. This is done to find the best way to change the dose
      of insulin 287. Participants will either get insulin 287 that they will have to inject once a
      week or insulin glargine that participants will have to inject once a day. Which treatment
      participants get is decided by chance. The study will last for about 5 months (23 weeks).
      Participants will have 14 clinic visits and 6 phone calls with the study doctor. At 3 of the
      clinic visits participants will be asked not to eat or drink anything (except for water) in
      the last 8 hours before the visit. During the study, the study doctor will ask participants
      to:

        -  measure blood sugar every day with a blood sugar meter using a finger prick.

        -  write down different information in a diary daily and return this to the study doctor.

        -  wear a medical device (sensor) that measure blood sugar all the time for 18 weeks (about
           4 months) during the study.

      Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study
      period.
    


Intervention name(s): Insulin icodec; Insulin Glargine
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously SC once weekly. Starting dose will be 70U.; Administered subcutaneously SC once daily.The starting dose will be 10U.
Other intervention name(s): Insulin 287
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rehabilitation Post Lumbar Microdiscectomy
Condition: Low Back Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether a rehabilitation program following lumbar
      microdiscectomy influences short-term (4 months) and long-term (up to 5 years)outcomes in
      quality of life, activity and endurance.
    

Detailed description: 
      Exercise
    

Intervention name(s): Other: Exercise
Intervention type(s): Procedure
Intervention description(s): exercise 3 times per week for 12 weeks
Other intervention name(s): exercise 3 times per week for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise