bioihbjkbjnl/mcl2 huggingface dataset:
Role Of Physical Therapy In Relieving Constipation In Children With Spastic Cerebral Palsy
Condition: Cerebral Palsy, Spastic
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy; Constipation
Study type: Interventional

Summary: 
      This study was conducted to determine the effectiveness of Physical Therapy management in
      relieving constipation among Spastic Cerebral Palsy children. There were two groups, Group A
      received routine Physical Therapy and Group B received maintenance Physical Therapy (aim to
      maintain current level of spasticity, functionality to avoid deterioration of conadition as
      approved by ASRC)
    

Detailed description: 
      Physical therapy makes an integral part of the non-pharmacological, conservative management
      of cerebral palsy. Routine physical therapy aims to reduce spasticity, improve joint range of
      motion (ROM), and improve strength and mobility.

      Passive ROM and stretching of lower limb and trunk increases parasympathetic activity and
      thus improves intestinal motility in prolonged bed ridden patients.Abdominal muscle training
      improves intestinal motility by two ways: mechanically by improving fecal propulsion towards
      rectum and neurologically by inducing parasympathetic activity to improve intestinal
      motility.20 Thermotherapy of back and abdomen in chronic constipation patient improves
      intestinal blood flow and parasympathetic activity.
    

Intervention name(s): Progressive Physical Therapy; Maintenance Physical Therapy
Intervention type(s): Other; Other
Intervention description(s): Stretching of the tight muscle, positioning, abdominal co activation; rolling etc to decrease muscle tone and functional independence.; Same Physical therapy protocol but aim was to maintain current level of spasticity and functioning
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The two groups were progressive physical therapy group and maintenance physical therapy group. For any given subject, spasticity, defecation frequency and constipation severity evaluations were completed on the same day. Each subject in PPT group completed 6 weeks of physical therapy sessions which were aimed to decrease spasticity, increase ROM, and improve strength and functional activity level. Each subject was evaluated for changes in symptoms on, 2nd week, 4th week and 6th week. In MPT group same protocol was used but the aim was to maintain current status of level of spasticity, ROM, strength and functional activity. After 6 weeks of physical therapy sessions were completed both groups underwent a 2-week washout period to eliminate the effects of 6-week physical therapy. After the washout period subjects were crossed over from PPT group to MPT group and vice versa.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cerebral Palsy; Spasticity; Constipation; Gross Motor Functional Classification Scale; Defecation Frequency; Constipation Severity
Toxicogenomic and Immunocytotoxic Effects of Propofol and Isoflurane Anesthetics in Patients Undergoing Elective Surgery
Condition: Patients in Good Health; Types of General Anesthesia; DNA Damage
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate if the anesthetics propofol and isoflurane can
      damage DNA, induce apoptosis, change expression of genes related to apoptosis and DNA repair
      and change cytokines profile in patients submitted to elective surgery.
    

Detailed description: 
      It is expected that the results provide relevant information to understand the possible
      adverse effects of anesthetics and contribute to the establishment of strategies aimed at
      reducing the risks to exposed individuals.
    

Intervention name(s): Comparison of two anesthetic drugs
Intervention type(s): Drug
Intervention description(s): Isoflurane 1,0 minimum alveolar concentration Propofol 2mg/kg and 4ug/ml
Other intervention name(s): Diprivan; Isoflurane
Intervention MeSH terms: Anesthetics; Isoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: isoflurane; propofol; genotoxicity; gene expression; cytokines; apoptosis
Study to Assess the Kinetic of the Analgesic Effect and Tolerability of Eschscholtzia Californica Versus Ibuprofen and Placebo in the Treatment of Pain After Surgery of the Third Molar
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to determine the kinetic of the analgesic effect of 500 mg and 1000 mg of Eschscholtzia
      Californica per os and placebo in patients undergoing dental surgery over an observation
      period of 6 hours. In a secondary analysis, kinetic of analgesic effect comparison between
      Eschscholtzia californica 500 mg, 1000 mg and Ibuprofen 200 mg
    


Intervention name(s): Eschscholtzia Californica - low dose; Eschscholtzia Californica - high dose; Ibuprofen; Eschscholtzia Californica - low dose Placebo; Eschscholtzia Californica - high dose Placebo; Ibuprofen Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is being conducted to evaluate the efficacy, safety and tolerability of 2%
      tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic
      dermatitis compared to placebo (vehicle) BID for 4 weeks.
    


Intervention name(s): Tofacitinib ointment 20mg/g; Placebo ointment (Vehicle)
Intervention type(s): Drug; Drug
Intervention description(s): Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks; Placebo ointment (vehicle) twice daily (BID) for 4 weeks
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; Atopic Eczema; Eczema; topical treatment; skin diseases; tofacitinib; CP-690; 550; Janus Kinase inhibitor
A Study by the Tracking Resistance to Artemisinin Collaboration (TRAC)
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is an open-label randomised trial comparing standard ACT treatment with matching
      triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and
      tolerability. The estimated total sample size is 2040 patients from 16 sites in Asia and 1
      site in Africa. There are 2 arm study groups that have 2 treatment arms each.

      Study group A:

      A.1: Artemether-lumefantrine for 3 days. versus: A.2: Artemether-lumefantrine for 3 days plus
      Amodiaquine for 3 days.

      Study group B:

      B.1: Dihydroartemisinin-piperaquine for 3 days. versus: B.2: Dihydroartemisinin-piperaquine
      for 3 days plus Mefloquine hydrochloride for 3 days.

      Study group C:

      C.1: Artesunate-mefloquine for 3 days versus: C.2: Dihydroartemisinin-piperaquine for 3 days
      plus Mefloquine hydrochloride for 3 days.

      According to the WHO guideline, all patients except for children under the age of 1 year or a
      weight below 10 kilograms will also be treated with a single dose of low dose primaquine.
    

Detailed description: 
      In Laos, Myanmar, Bangladesh, India and DRC, the following two combinations will be used:

        1. Artemether-lumefantrine combined with amodiaquine (TACT arm) or

        2. Artemether-lumefantrine (ACT arm)

      In Myanmar and Vietnam the following two combinations will be used:

        1. Dihydroartemisinin-piperaquine combined with mefloquine (TACT arm) or

        2. Dihydroartemisinin-piperaquine (ACT arm)

      In Cambodia and Thailand the following two combinations will be used:

        1. Dihydroartemisinin-piperaquine plus Mefloquine hydrochloride (TACT arm) or

        2. Artesunate-mefloquine (ACT arm)
    

Intervention name(s): ACT; TACT
Intervention type(s): Drug; Drug
Intervention description(s): Artemether-lumefantrine for 3 days
Dihydroartemisinin-piperaquine for 3 days.
Artesunate-mefloquine for 3 days; Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days.
Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days.
Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artemisinin combination Therapies
Efficacy of Lyophilized Dried Cornus Mas L. on Anthropometric and Biochemical Parameters in Insulin Resistance
Condition: Insulin Resistance; Obesity; PreDiabetes
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of 3 months supplementation of lyophilize
      dried cornelian cherry (Cornus mas L.) on women diagnosed with insulin resistance. The
      baseline and end biochemical parameters and anthropometric measurements will be compared with
      control subjects.
    

Detailed description: 
      The main purpose of this study is to determine the efficacy of the lyophilizer-dried powder
      form of cornelian cherry (Cornus mas L.) grown in our country on inflammation in women with
      insulin resistance by biochemical parameters.

      Sub-objectives of the study;

        -  Determining the presence of inflammation in women with insulin resistance.

        -  Determination of the effect of cornelian cherry on both fasting blood glucose, insulin
           and blood lipid profile.

        -  Determination of both anti-inflammatory, antidiabetic and antioxidant effects of
           cornelian cherry.

        -  Determination of the effect of cornelian cherry on anthropometric measurements.

      The aim of this study is to compare the anthropometric measurements and biomarkers of women
      with insulin resistance as a result of the consumption of powdered cornelian cherry (Cornus
      mas L.) that has been freeze-dried at -55 degrees with a Lyophilizer device for 12 weeks.
    

Intervention name(s): Cornelian Cherry (Cornus mas L.); Diet
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): Patients in "Cornelian Cherry Group" and "Cornelian Cherry and Diet Group" will receive 20 g/day freeze-dried powder Cornelian Cherry supplement.; Patient in "Diet Group" and "Cornelian Cherry and Diet Group" will be given a personalized diet and be followed up by a dietician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cornelian Cherry; Cornus mas L.; Insulin Resistance; Nutrition; Anthropometry
Surgical Stress After Laparoscopic Compared to Open Liver Resection
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the postoperative insulin resistance and
      cytokine release would be attenuated in laparoscopic compared with open liver resection.
    


Intervention name(s): laparoscopic liver resection
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: laparoscopic liver resection; cytokine release
The Effect of Tart Cherry (Prunus Cerasus) Concentrate on Physiological and Cognitive Function
Condition: Cardiometabolic Risk Factors; Cognitive Function; Exercise Capacity
Study type: Interventional

Summary: 
      A randomized, double blind, counterbalanced, placebo controlled independent groups design to
      determine the effects of 3 month supplementation with tart cherry concentrate on indices of
      cardiometabolic health, exercise capacity and cognitive function. Following screening and
      recruitment, participants are familiarised with the testing equipment and procedures after
      which they will be randomly assigned to receive either Montmorency tart cherry concentrate
      (MC) or an isocaloric placebo (PLA), stratified by gender. The study is comprised of two
      experimental visits and outcome variables are assessed at baseline (before supplementation)
      and at 3 months (follow up; after supplementation).
    


Intervention name(s): Montmorency tart cherry concentrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Based on previous analysis done by our laboratory each 60 ml of Montmorency tart cherry concentrate contains approximately 73.5 mg of anthocyanins (cyanidin-3-glucoside equivalents) and 178.8 mg of total phenolics (mean gallic acid equivalents); Placebo beverage matched for calorie content and visual properties of the cherry concentrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tart cherry; Montmorency cherries; Prunus Cerasus
A Phase 2a Study to Evaluate the Effect of Rilapladib (SB-659032) in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to investigate the effects of rilapladib on biomarkers related to the
      Alzheimer's disease, and cognitive function.
    

Detailed description: 
      The study is in subjects with Alzheimer's disease and evidence of cerebrovascular disease
      (CVD) who are currently treated with an acetylcholinesterase inhibitor (AChEI) and/or
      memantine. The study is a randomized, double-blind, placebo controlled, parallel group,
      repeat dose design, in which subjects (up to 60 randomized subjects per arm) will receive
      oral placebo or rilapladib (250 mg), once daily for 24 weeks in addition to their stable
      background AD therapy consisting of an acetylcholinesterase inhibitor (AChEI) and/or
      memantine. Subjects will take 250mg of rilapladib or placebo once daily for a period of 24
      weeks. The total duration of participation for each subject will be approximately 30 weeks
      comprising approximately 4 weeks screening, 24 weeks treatment and 2 weeks follow-up. From
      the time of randomization and throughout the treatment period subjects will attend visits
      after 1 week, 4 weeks and thereafter every 4 weeks until Week 24. A follow-up visit will
      occur approximately 2 weeks after the final dose of study medication. Cognitive assessments
      will be performed at the screening visit, at the randomization (baseline) visit and at weeks
      12 and 24 of the treatment period. Cerebrospinal fluid (CSF) samples will be taken via lumbar
      puncture at baseline and Week 24 for biomarker analyses related to Alzheimer's disease. Blood
      samples will be collected throughout the study for pharmacokinetics and a range of biomarker
      analyses. A range of safety and tolerability assessments will also be performed (including
      vital signs, laboratory tests, eye examinations and ECGs).
    

Intervention name(s): 250mg rilapladib; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Experimental Drug; Placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's disease
SB208 for the Treatment of Tinea Pedis
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be
      conducted in non immunocompromised adult subjects with interdigital tinea pedis.
    

Detailed description: 
      A phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted
      in approximately 170 non immunocompromised adult subjects with interdigital tinea pedis.
      Subjects will apply the investigational product (IP) (SB208 or Vehicle Gel) to the
      interdigital areas and all affected and immediate surrounding areas of one or both feet once
      daily for 2 weeks, followed by a 4-week post-treatment observation period.
    

Intervention name(s): SB208 2%; SB208 4%; SB208 16%; Vehicle Gel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Apply once daily to one or both feet for 14 days; Apply once daily to one or both feet for 14 days; Apply once daily to one or both feet for 14 days; Apply once daily to one or both feet for 14 days
Other intervention name(s): NVN1000 4%; NVN1000 8%; NVN1000 32%; Vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Smartphone-based Intervention to Promote an Active Lifestyle in Low Educated Working Young Adults
Condition: Physical Activity
Study type: Interventional

Summary: 
      The aim of this smartphone-based intervention study is to determine whether a newly developed
      app is effective in promoting an active lifestyle in low educated working young adults.
    

Detailed description: 
      A stepwise approach was used to develop a new native Android smartphone app (Active Coach).
      This app aims to promote an active lifestyle (through physical activity and active transport)
      in low educated working young adults. The development of this app is based on theory,
      evidence and user's experiences. The app focuses on four determinants (knowledge, attitude
      (perceived benefits and perceived barriers), social support and self-efficacy) and includes
      several behavioral change techniques (self-monitoring, goal-setting, feedback on behavior,
      review behavior goals, instruction on how to perform the behavior, information about health
      consequences, enhancing network linkages and prompts/cues). Furthermore, the app works in
      combinations with a wearable activity tracker (Fitbit Charge) to track users activity
      behavior.

      For the smartphone-based intervention, 120 low educated working young adults are being
      recruited via purposeful convenience sampling though companies and employers. Participants
      can not have any medical conditions that prevent them from being physically active and they
      need to own an Android smartphone. Fitbit Charge activity trackers will be provided. The
      participants will be randomly divided in the intervention group or the standard information
      control group. The intervention period will be nine weeks. At the beginning and the end of
      the intervention period, physical activity levels will be objectively measured with
      accelerometers. Follow-up measurements will be conducted 12 weeks after the end of the
      intervention period.
    

Intervention name(s): smartphone based intervention with Active Coach app
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: pre, post, follow up measurements with an intervention and control group
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: intervention; mHealth; physical activity; active transport; smartphone; application
The Effect of Nasal Carbon Dioxide (CO2) on Nasal Congestion in Subjects With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of nasal CO2 on nasal congestion and
      other symptoms related to Perennial Allergic Rhinitis.
    

Detailed description: 
      A randomized study to evaluated the safety and effect of nasal carbon dioxide on nasal
      congestion using acoustic rhinometry in subjects with perennial allergic rhinitis. The
      acoustic rhinometry is an instrument that will be used to assess the levels of the nasal
      congestion in each subject. Approximately 20 men and women ages 19-65 years old who have a
      history consistent with perennial allergic rhinitis requiring pharmacology for at least 2
      years and meet all other eligibility criteria will be enrolled in this study. There will be
      six (6) visits to the clinic. There will be a screening visit, four (4) treatment visits, and
      an end of study visit. A subject's participation in the study may last up to 58 days. There
      will be four different doses given in this study. Each subject will receive 3 different doses
      of the study drug and one dose of the placebo.
    

Intervention name(s): Nasal Carbon Dioxide; Nasal Carbon Dioxide; Nasal Carbon Dioxide; Nasal Carbon Dioxide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Nasal Carbon Dioxide; Nasal Carbon Dioxide; Nasal Carbon Dioxide; Nasal Carbon Dioxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic Rhinitis; Perennial Allergic Rhinitis; Allergies to perennial allergens; Allergies to perennial allergens (e.g. dog, cat, dust mites, etc.)
Luteal Phase Commencing of Growth Hormone
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Commencing of growth hormone in luteal phase when follicular cohort for the next cycle is
      being gathered may increase mature oocytes in poor responder
    


Intervention name(s): Norditropin pen
Intervention type(s): Drug
Intervention description(s): 12 IU per day
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        poor response to previous COH in the same center
      
Keywords: poor responder; growth hormone; luteal
Safety and Tolerability of PQ912 in Subjects With Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the safety, tolerability and preliminary efficacy of
      PQ912 in subjects with Mild Cognitive Impairment (MCI) due to Alzheimers Disease (AD) or mild
      dementia due to AD.
    


Intervention name(s): PQ912 oral; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PQ912; Glutaminy Cyclase (QC); QC - Inhibitor