bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Safety, Tolerability, PK, and PD of ILV-094 Administered IV or SC to Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of ascending single IV
      doses of ILV-094 (an investigational drug) and one SC dose of ILV-094 in healthy subjects.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, inpatient/outpatient,
      sequential-group study of ascending single IV doses of ILV-094 administered to healthy
      Japanese male subjects.
    

Intervention name(s): ILV-094
Intervention type(s): Drug
Intervention description(s): Single, ascending doses of 5, 15, 50, 100, 300, and 600 mg IV or SC dose of ILV-094 or placebo
Intervention MeSH terms: Fezakinumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Absorption of Vitamin K2
Condition: Healthy
Study type: Interventional

Summary: 
      From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of
      vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7.
      However, the taste of natto is not appreciated by the western society. For this reason the
      active biological compound is produced as a capsule. Different techniques of encapsulation
      the vitamin can lead to different absorption profiles with intake. Therefore it is important
      to study influence of type of encapsulation technique on absorption of menaquinone-7.

      This study is undertaken to compare absorption of menaquinones between two different
      encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of
      conventional softgel capsules and newly developed GellpelTM capsules are compared between
      each other.
    


Intervention name(s): Vitamin K2 in softgel; Vitamin K2 in Gelpell
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4 softgel capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 softgel capsules containing 30 µg MK-4 per capsule; 4 Gelpell capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 Gelpell capsules containing 30 µg MK-4 per capsule
Intervention MeSH terms: Vitamins; Vitamin K; Vitamin K 2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: absorption; encapsulation; menaquinone; Bio-availability
Echocardiography, Adherence to Mediterranean Diet (AMDS) and Physical Exercise in Fatty Liver
Condition: Fatty Liver
MeSH terms: Fatty Liver
Study type: Observational

Summary: 
      NAFLD is associated with unhealthy lifestyle and obesity, without alcohol habits. An
      association of NAFLD with coronary artery disease and with impaired heart function was
      reported, but without considering severity of NAFLD and with the bias of including diabetes.
      Aim: to challenge if severity of liver steatosis assessed by UltraSound Bright Liver Score
      (BLS) can predict the impairment of systolic heart function, assessed by echocardiography
      (Ejection Fraction, EF), diastolic function (assessed by E/A ratio), Left Ventricular Mass,
      Left atrial diameter.
    

Detailed description: 
      METHOD and measures: Age, obesity (BMI) , dietary profile (assessed as Adherence to
      Mediterranean Diet Score, AMDS), physical activity profile, assessed by the Baecke's physical
      exercise questionnaire, Insulin resistance (assessed by HOMA) were all taken into account for
      their confounding and synergic effect. Multiple regression analysis and Odds ratio will be
      the statistical tools that will be used.Receiver operator curve (ROC) analysis will be
      applied in order to find the cut-off, if any, of the considered measures vs. NAFLD and
      significant abnormalities of echocardiography measures.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        subjects withour acute or chronic disease checked by US imaging of the liver during routine
        work-up for dietary and physical exercise counseling
      
Keywords: diet
The Effects of Polyphenol-rich Berry Juice on Blood Pressure in Hypertensive Subjects
Condition: Pre-hypertension; Hypertension
MeSH terms: Hypertension; Prehypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the effects of berry juices containing different
      levels of polyphenols on blood pressure and other cardiovascular risk factors.

      The study is a 12 week double blinded randomized controlled intervention trial. The subjects
      will be divided in three groups where one receives a placebo juice while the two other will
      consume 0.5 liter of juice containing different levels of polyphenols. Blood pressure will be
      monitored and blood samples will be taken.
    


Intervention name(s): Placebo; Mana-juice; Optijuice
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 500 ml/day Per 100g 6.25 g sucrose 6.25 g maltodextrin 1.3 g citric acid E330 (pH 3.0) 2.5 g Carmine solution E120 (4% carmine colouring agent) 0.025 g blueberry aroma Potassium sorbate E202 water; 500 ml/day of a grape,cherry, bilberry,aronia juice 13g carbohydrates/100g 150mg K/100g; 500 ml/day of a Grape,cherry, bilberry,aronia, black current juice 13g carbohydrates/100g 150mg K/100g
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of a High Calcium Breakfast on Exercise Metabolism and Appetite
Condition: Exercise Fat Oxidation
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of a high calcium breakfast on substrate
      metabolism during exercise and appetite throughout the day.
    


Intervention name(s): High calcium milk; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): High calcium milk (9 mg/kgBM); Regular Milk
Intervention MeSH terms: Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this protocol is to investigate the monoaminergic
      (dopamine、serotonin、and norepinephrine ) nervous system and amyloid deposition in Parkinson's
      disease patients with non-motor symptoms (focus on impulse control disorders and dementia) by
      novel 18F-DTBZ and Florbetapir F-18 PET imaging.

      This study will compare the amyloid deposition of brain by florbetapir F-18 PET imaging and
      monoaminergic function by18F- DTBZ PET in NC group, PD group, PDD group, AD group.

      Investigators will also analyze monoaminergic function by18F- DTBZ PET in PDI group.
    

Detailed description: 
      Study duration is expected to be completed in a period of 3 year. This study will compare the
      amyloid deposition of brain by florbetapir F-18 PET imaging and monoaminergic function by18F-
      DTBZ PET in 10 age-matched healthy subjects (NC group), 30 PD patients without dementia/ICD
      (PD group), 30 PD patients with dementia (PDD group), and 20 patients with dementia (AD
      group). We will also analyze monoaminergic function by18F- DTBZ PET in 30 PD patients with
      ICD (PDI group).

      Each evaluable subject involved in this study must fulfill all the inclusion and exclusion
      criteria according the subject grouping, healthy subjects, PD, PDD, and AD patients will have
      4 visits in this study ,as one screening visit, one florbetapir F-18 imaging visit, one
      18F-DTBZ imaging visit, and one safety evaluation.PDI patients will have 3 visits in this
      study, as one screening visit, one 18F-DTBZ imaging visit, and one safety evaluation. Safety
      measurement will be evaluated by medical history, vital signs, physical examinations,
      laboratory examinations and collecting of adverse events.
    

Intervention name(s): 18F- DTBZ
Intervention type(s): Drug
Intervention description(s): During this study, subjects will receive a single i.v. administration of approximately 370MBq (10 mCi) 18F- DTBZ immediately prior to imaging. The dosage of DTBZ is 10 nmole. The effective dose in human body is about 5.6 mSV.
During this study, subjects will receive a single i.v. administration of approximately 370MBq (10 mCi) florbetapir F-18 immediately prior to imaging. The dosage of DTBZ is 10 nmole. The effective dose in human body is about 5.6 mSV.
The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG (Lin 2010).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 18F-DTBZ
Dose Proportionality of Fexofenadine in Healthy Human Egyptian Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      The present study was adopted to evaluate the pharmacokinetics and dose linearity of
      fexofenadine after oral administration.
    

Detailed description: 
      The present study was adopted to evaluate the pharmacokinetics and dose linearity of
      fexofenadine after administration of single oral doses of 60 to 360 mg in an open-label,
      five-way crossover study.
    

Intervention name(s): fexofenadine
Intervention type(s): Drug
Intervention description(s): fexofenadine brand name
Other intervention name(s): Telfast
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Fexofenadine; Pharmacokinetics; Bioavailability; Linearity; HPLC; Dose proportionality of fexofenadine in Egyptian volunteers
Different Glycemic Index (GI) Values in 7 Food Products
Condition: Glycemic Index
Study type: Interventional

Summary: 
      This study is initiated to investigate the glycemic index value of seven food products.
    


Intervention name(s): Low GI Standard Breakfast; Medium GI Standard Breakfast; Enfamama A+; Glucerna Triple Care; Dumex Precima; Diasip; Test product
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Low GI Standard Breakfast; Medium GI Standard Breakfast; Nutritional pregnant milk supplement; Nutritional product for diabetics; Pregnant and lactation women milk powder; Nutritional drinks for diabetics; Test product not patented yet
Other intervention name(s): Not patented yet, cannot disclose name.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
The Effect of Desloratadine and Levocetirizine on Nasal Obstruction (Study P03609)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Nasal Obstruction
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a study to measure the ability of desloratadine and levocetirizine to decrease nasal
      obstruction in subjects who had study-induced allergic rhinitis. Study participants had
      allergic rhinitis symptoms induced in a Vienna Challenge Chamber and then received
      desloratadine or levocetirizine for 8 days. After at least a 10 to 35-day washout period
      (time when no drug is given), subjects received the opposite treatment for 8 days. Subjects
      had their total nasal symptom measured.on the 8th day of each treatment period.
    


Intervention name(s): desloratadine; levocetirizine
Intervention type(s): Drug; Drug
Intervention description(s): desloratadine 5 mg daily x 8 days; levocetirizine 5 mg daily x 8 days
Other intervention name(s): Clarinex, SCH 034117; XYZAL®
Intervention MeSH terms: Levocetirizine; Desloratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      In this study, the investigators aimed to compare the efficacy of %5, %10 and %20
      concentration dextrose prolotherapy (DPT) treatments in patients with primary knee
      osteoarthritis (OA). In this prospective, randomized, controlled, single-blind study, 128
      patients who met the inclusion criteria were recruited and divided into four groups. Thirty
      patients from each group completed the study. %5 DPT was applied to Group 1, %10 to Group 2,
      and %20 to Group 3 in combination with home exercise program and hotpack therapy. Group 4 was
      given home exercise program and hotpack therapy. Groups were evaluated with VAS (Visual
      Analog Scale), WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), knee
      ROM (Range of Motion), and Timed up and go test (TUG) parameters. DPT groups were evaluated
      in terms of side effects.
    


Intervention name(s): Prolotherapy; Home based exercise program; Hotpack therapy
Intervention type(s): Other; Other; Other
Intervention description(s): DPT was applied as a total of 3 sessions at 0, 3 and 6 weeks. In each session, intra-articular 5 ml and periarticular 10 ml dextrose injections were administered to the knee. Periarticular injection was applied to 10 points as 1 ml in each region. The regions were determined as medial and lateral coronary ligaments, proximal and distal medial and lateral collateral ligaments, pes anserinus region, proximal and distal patellar tendon, quadriceps tendon attachment area.; Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.; Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Probiotic Intervention After Surgical Removal of Mandibular Third Molars
Condition: Surgery--Complications; Molar, Third
Study type: Interventional

Summary: 
      Single-center, double-blind, randomized trial of probiotics L. plantarum KABP-051 (CECT7481)
      and L. brevis KABP-052 (CECT7480) taken twice daily for 7 days after surgical removal of both
      mandibular 3rd molars. Patients were assessed for surgery-derived complications in a
      follow-up visit 7 days after surgery, and provided daily evaluations of pain, swelling and
      eating difficulty in a patient diary.
    

Detailed description: 
      This was a single-centre, prospective, double-blind, randomized, placebo-controlled,
      parallel-group study to evaluate whether probiotic supplementation during 1 week after
      surgery reduced post-surgery complications compared to placebo.

      Healthy subjects of both genders aged between 14 and 25 years who required the surgical
      removal of both mandibular 3rd molars were recruited from the department of Oral and
      Maxillofacial Surgery at the Foundation of Hospital de Nens de Barcelona (Children's Hospital
      of Barcelona).

      Patients were randomly assigned to receive probiotic tablets containing a mixture of L.
      plantarum KABP-051 (CECT7481) and L. brevis KABP-052 (CECT7480) or to receive placebo, twice
      a day for 7 days post surgery.

      Patients were assessed by trained specialists for surgery-derived complications (fever, oral
      alveolitis, alveolar osteitis, trismus) in a follow-up visit 7 days after surgery. Patients
      also provided daily evaluations for pain, swelling and eating difficulties in a patient
      diary.
    

Intervention name(s): Probiotic AB-DENTALAC; Placebo; Surgical removal of mandibular third molars at baseline; Ibuprofen
Intervention type(s): Dietary Supplement; Other; Procedure; Drug
Intervention description(s): Orodispersible tablets containing Lactobacillus plantarum [now Lactoplantibacillus plantarum] KABP051 (CECT7481) and Lactobacillus brevis [now Levilactobacillus brevis] KABP052 (CECT7480) as active ingredients, at a minimum dose of 5x10^8 cfu each, and sorbitol (E420) and guar gum (E412) as excipients, taken b.i.d. for 7 days.; Orodispersible tablets made of sorbitol (E420) and guar gum (E412), taken b.i.d for 7 days.; Surgical removal of both mandibular third molars, performed under intravenous sedation and loco-regional anesthesia (Articaine Hydrochloride 4% with Epinephrine 1:100.000), after having undergone a professional oral cleaning.; Ibuprofen syrup at 20-30 mg/Kg of body weight, orally every 8 hours (t.i.d), for 7 days
Other intervention name(s): Dalsy
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Probiotic; Molar removal surgery; Oral pain; Maxillofacial surgery
A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objectives of this study are to evaluate the safety and efficacy of VI-0521
      compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and
      to assess the relative contributions of weight loss on parameters of OSA in these subjects.
    


Intervention name(s): VI-0521; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 15 mg Phentermine and 92 mg Topiramate; placebo
Other intervention name(s): Qnexa; PHEN/TPM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sleep apnea; obesity
Effect of SNAGs on Stiffness of Lumbar Stabilizer Muscles
Condition: Low Back Pain; Manuel Therapy
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain is a common health problem worldwide. Epidemiological studies have shown that
      70-80% of all people are affected at least once in their lifetime. Although it is common,
      often the cause of the pain has not been determined and is called 'nonspecific low back pain.

      Low back pain has been shown to alter the structure of deep and superficial muscles such as
      multifidus and erector spinae. However, it has not been fully explained how changes in muscle
      fiber structure affect the biomechanical properties and functions of the muscle.

      There are various manual therapy techniques in the treatment of low back pain. Manual
      therapists use treatment modalities that include passive techniques such as mobilization and
      manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a
      sustained transverse glide to the spinous process of a vertebra while actively or passively
      performing. These techniques have gained the name "Sustained Natural Apophyseal Glides"
      (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal
      joints under treatment.

      Ultrasound shear wave elastography (SWE) provides an advantage since it can quantitatively
      assess tissue elasticity of in vivo skeletal muscles through non-invasive high-frequency
      ultrasound waves.

      The aim of this study was to investigate the acute effect of Mulligan SNAGs on the stiffness
      of muscle tissue by using Ultrasound shear wave elastography which is an objective assessment
      technique.
    


Intervention name(s): Real Sustained Natural Apophyseal Glides (SNAGS); Sham Sustained Natural Apophyseal Glides (SNAGS)
Intervention type(s): Other; Other
Intervention description(s): Manual therapists use treatment modalities that include passive techniques such as mobilization and manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a sustained transverse glide to the spinous process of a vertebra while actively or passively performing. These techniques have gained the name "Sustained Natural Apophyseal Glides" (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal joints under treatment.; The participants in the Sham SNAGs group will be positioned same as the SNAG group. Mulligan belt will be used, which included the patient's waist and physiotherapist's hip. The physiotherapist will place the hypothenar region of his hand on the spinous processes of the symptomatic lumbar spine levels and waited a few seconds without no glide will be performed. Sham SNAGs practice consisted of 3 sets of 6 repetitions and a 60-second rest period was given between the sets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Serratus Plane Block in Preventing Postoperative Pain of Mastectomy
Condition: Serratus Plane Block; Chronic Pain; Breast Cancer
MeSH terms: Breast Neoplasms; Chronic Pain; Pain, Postoperative
Study type: Interventional

Summary: 
      A prospective, double-blinded randomized controlled, 1-year follow-up study was designed to
      compare the analgesic effect of serratus plane block (SPB) after breast cancer surgery. Women
      undergoing radical mastectomy were dIvided into Control group and SPB group. The
      postoperative acute pain was evaluated by numerical rating scale (NRS) and the effect of
      preventing chronic pain was assessed at 3, 6, 12 months after surgery by NRS.
    


Intervention name(s): serratus plane block with local anesthetic; serratus plane block with saline
Intervention type(s): Procedure; Procedure
Intervention description(s): The high-frequency linear array ultrasound transducer (UST) was placed parallel to the cephalocaudal axis of the body in T4 levels on the side of the mid-axillary line, identifying latissimus dorsi and serratus anterior, through the thoracic artery to help to find the serratus anterior and 15 ml 0.25% ropivacaine was administered.; The high-frequency linear array ultrasound transducer (UST) was placed parallel to the cephalocaudal axis of the body in T4 levels on the side of the mid-axillary line, identifying latissimus dorsi and serratus anterior, through the thoracic artery to help to find the serratus anterior and 15 ml saline was administered.
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Functional MRI of Stress in Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      To examine the influence of obesity on brain activation during food cue, stress, and neutral
      relaxing conditions
    

Detailed description: 
      Subjects will participate in an fMRI session to examine changes in frontal and limbic brain
      regions with food cues, stress and neutral/relaxing imagery
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        30 obese subjects and 30 matched healthy controls will be recruited for this study.