bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose
      of [14C]-BI 207127 and to characterize the metabolic profile following single dose
      administration.
    


Intervention name(s): BI 207127 NA
Intervention type(s): Drug
Intervention description(s): Single oral solution dose of BI 207127 NA combined with [14C]-BI 207127 NA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Targeted Training for Trunk Control_case Series Cerebral Palsy
Condition: Cerebral Palsy; Traumatic Brain Injury
MeSH terms: Brain Injuries; Cerebral Palsy; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      If a child with cerebral palsy does not develop independent sitting balance by 4 years of
      age, their prognosis for walking is very poor. Surprisingly little is known about how to
      facilitate head control or upright sitting balance and functional mobility in the child who
      is not developing these skills. This is one of the first studies that will examine
      intermediate stages in the development of the postural control system in children with
      neurologic deficits. Clinical researchers at The Movement Centre in Oswestry, England have
      developed a method called Targeted Training in which trunk control is trained in children
      segment by segment using a specific training device. This study aims to examine kinematic and
      electromyographic changes in a case series of children who undergo a 6-month Targeted
      Training intervention.
    


Intervention name(s): Targeted Training
Intervention type(s): Device
Intervention description(s): Custom training devices were imported from The Movement Centre for research purposes. The typical course of treatment involves loaning the customized equipment to each family for use in their home or in their child's educational setting. Training occurs once daily usually for 30-45 minutes. This is done 5 or 6 days per week. Training programs typically involve playing with balls or balloons or video games that motivate the child to hold the head erect and to wave the arms and hands and move the upper body.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: postural control; Targeted Training; cerebral palsy; trunk segments
The Cognitive Functioning of Young Athletes Including Bioelectrical Brain Function
Condition: Cognitive Function
Study type: Observational

Summary: 
      The project focuses on two central issues:

        1. The impact of intensity of sport on the cognitive functioning and brain waves of
           children in late childhood (10-12 years old);

        2. The specific impact of individual forms of sporting competitions classified according to
           dynamic, static components as well as closed / open skill exercise. The variables will
           be age, gender, and fluid intelligence. Additionally, children's temperament will be
           examined in order to assess its relationship with the preferences for choosing a
           particular type of sport activity and the intensity of this activity.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The participants will be recruited for research via Szkoły Mistrzostwa Sportowego [Sports
        Championship Schools] (criterion groups), sports clubs, as well as by establishing contact
        with other primary schools. Selecting 40 - 45 people aged 10-12 for each of the 2 control
        groups differentiated by the dynamic, static factor and nature of the sport close / open
        skill and for the comparative group of 40-45 children who are cognitively stimulated
        through physical activity and / or otherwise.

        They will be enrolled to the study after giving their and their parents written consent to
        participate in the study.
      
Keywords: cognitive function; sport; football; gymnastics; children
Bioequivalence Study of Meloxicam Capsules 15 mg (Mobic® Capsules 15 mg) Versus Meloxicam Tablets 15 mg (Mobic® Tablets 15 mg) in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To access the bioequivalence of meloxicam capsule 15 mg (Test, T) to meloxicam tablet 15mg
      (Reference, R) following oral administration.

      Secondary Objective:

      To investigate the safety and tolerability of meloxicam following a single dose of meloxicam
      capsule 15 mg vs. meloxicam tablet 15 mg under fasting conditions in healthy male Taiwanese
      subjects.
    


Intervention name(s): Meloxicam capsule; Meloxicam tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Exploratory Study of Ganglioside GM1 in Acute Ischemic Stroke
Condition: Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate the efficacy and safety of higher doses of
      monosialoganglioside GM1 injection in the treatment of patients with acute ischemic stroke.
    


Intervention name(s): Monosialoganglioside GM1
Intervention type(s): Drug
Intervention description(s): Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days
Other intervention name(s): GM1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: monosialoganglioside GM1; Ischemic Stroke
Physical Fitness in Elderly
Condition: Aging; Healthy Aging; Physical Fitness
Study type: Interventional

Summary: 
      Aging decreases the physical fitness levels in living beings. The environmental factors also
      have a major effect on the physical fitness levels. The objective of this study was to
      compare the physical fitness levels of nursing home residents and community-dwelling elderly
      people. This study employed 118 participants, who consisted of nursing home residents and
      community-dwelling elderly people. The physical fitness levels of the elderly people were
      measured by Senior Fitness Test. The physical fitness levels of the elderly people were
      measured by Senior Fitness Test. Chair stand test, arm curl test, 2-minute step test, chair
      sit and reach test, back-scratch test, 8-foot up and go test and body mass index were
      measured.
    


Intervention name(s): Senior Fitness Test
Intervention type(s): Diagnostic Test
Intervention description(s): Chair stand test:The number of full stands performed on a seated position that can be completed within 30 seconds was recorded.
Arm curl test: The participants were asked to lift weights starting with a full elbow extension and then full flexion.
2-minute step test: The participant was asked to begin stepping as quickly as possible to reach the marked height for two minutes.
Chair sit-and-reach test:The participant could extend right or left knee to a full extension, heel on the floor and ankle in a neutral position of 90 degrees. Then, the participant was asked to reach to the toes.
Back-scratch test:The participant was asked to stand up and place his/her preferred hand over the same shoulder, palm down and fingers extended, and reach down the middle of the back as far as possible.
8-foot up and go test:The participant was asked to get up from a chair without any arm support and walk a distance of 2.44 meters; then turn around a cone and come back to sit down on the chair.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized clinical trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: aging; community dwelling; health; nursing homes; physical fitness
Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin)
Condition: Capsaicin Evoked Pain; Heat Sensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate
      the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms
      and heat sensitivity in healthy volunteers
    


Intervention name(s): AZD1386; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution fixed dose (95 mg given orally on two occasions); Oral solution fixed dose (95 mg given orally on two occasions)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Proof of Mechanism; Capsaicin evoked pain
Lidocaine Usage for Pupil Dilatation (Mydriasis)
Condition: Cataract
MeSH terms: Cataract; Mydriasis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the mydriatic effect of intracameral lidocaine
      1% is as effective as topical cyclopentolate 1% and phenylephrine 10% for achieving effective
      mydriasis during phacoemulsification surgery.
    

Detailed description: 
      Former studied done on the effect of Intracameral lidocaine 1% compared to topical mydriatic
      agents for achieving effective mydriasis during phacoemulsification surgery have compared 2
      different groups of patients, ie; One group received topical agents and the other received
      intracameral lidocaine. The resultant pupil size was recorded and evaluated in the 2 groups.
      Our purpose is to compare the effect of these agents on the same group of people.

      Patients recruited will be invited first for evaluation at least 1 week before the surgery.
      During this evaluation 1 dose (drop) of topical cyclopentolate 1% and Phenylephrine 10% will
      be instilled to the evaluated eye 3 times at 10 minutes intervals. After 1 hour from the last
      instillation pupil diameter will be recorded. In the second part of this study during the
      phacoemulsification surgery patients will be given intracamerally lidocaine 1% (0.2 ml) and
      the pupil size will be recorded after 90 seconds. the resultant values will be
      evaluated/compared.
    

Intervention name(s): Lidocaine 1% (sterile)
Intervention type(s): Drug
Intervention description(s): during the phacoemulsification surgery patients will be given intracamerally lidocaine 1% (0.2 ml) and the pupil size will be recorded after 90 seconds
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cataract; Mydriasis; Lidocaine
Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN)
Condition: Healthy
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the metabolic consequences of a moderate weight
      gain and if the type of dietary fat (saturated versus polyunsaturated) can modify the effects
      in young healthy adults. Hypothesis: the type of dietary fat can modify the effects of weight
      gain.
    

Detailed description: 
      Specific goals:

        -  Investigate if dietary fat composition influences liver fat accumulation and metabolic
           risk factors in response to moderate weight gain

        -  Investigate if polyunsaturated fat (PUFA) in the diet could counteract any unfavorable
           metabolic changes that are expected to accompany moderate weight gain

        -  Investigate effects of weight gain and dietary fat composition on markers of vascular
           health
    

Intervention name(s): Polyunsaturated fatty acid group; Saturated fatty acid group
Intervention type(s): Other; Other
Intervention description(s): Addition of polyunsaturated fatty acids to the diet in the form of pastries; Addition of saturated fatty acids to the diet in the form of pastries
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Liver fat; Polyunsaturated fatty acids (PUFA); Saturated fatty acids (SFA); Weight gain; Overfeed; Dietary fatty acids; Palm oil; Sunflower oil
Comparison of Two Liraglutide Formulations in Healthy Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of two
      formulations of liraglutide.
    


Intervention name(s): liraglutide; liraglutide
Intervention type(s): Drug; Drug
Intervention description(s): Single dose administered as subcutaneous injection; Single dose administered as subcutaneous injection
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of the Management of Tramadol Use Disorders
Condition: Withdrawal
Study type: Observational

Summary: 
      In France, In recent years, there has been a steady increase in reports of abuse and
      dependence on tramadol. Over 50% of tramadol withdrawal syndromes involve taking tramadol in
      therapeutic doses, sometimes for short periods of less than a week. Physical dependence can
      develop when a therapeutic maintenance dose is prescribed for the treatment of mild to
      moderate pain. Due to its mixed mechanism of action, tramadol withdrawal syndromes are not
      only characterized by classic signs of opioid withdrawal (muscle pain, mydriasis, sweating,
      nausea and vomiting, tearing, rhinorrhea, yawning, fever, insomnia, etc.). The properties of
      this substance on serotonin explain the effects which are added to the morphine-mimetic
      withdrawal of tramadol. Analysis of spontaneous reports shows "psychological and psychic"
      signs of withdrawal. Currently, there is no validated protocol for the management of tramadol
      withdrawal. The main objective is to assess the different options for managing tramadol
      withdrawal: opioid maintenance therapy and symptomatic treatments, in relation to the
      addictive and psychiatric co-morbidities in patients. The study also provides insight into
      the different types of withdrawal syndromes experienced by patients in order to raise
      awareness among doctors when prescribing tramadol.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adults hospitalized in Montpellier University Hospital and Nîmes University Hospital for
        Tramadol withdrawal
      
Keywords: Substance use disorder; Programme de Medicalisation des Systèmes d'Information; tramadol
Gonadotropin-releasing Hormone Antagonist on Triggering Day: A Randomized Controlled Study
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Gonadotropin-releasing hormone (GnRH) antagonists have been widely used for the prevention of
      premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation (COH)
      for in vitro fertilization and embryo transfer (IVF-ET) since the late 1990's.

      Many years have passed since GnRH antagonists were introduced to prevent premature LH surges
      during stimulated cycles. However, there is still no consensus on the optimal GnRH antagonist
      protocol. Attempts at modifying GnRH antagonist protocols have been made to improve COH
      outcomes. However, a meta-analysis of 27 randomized controlled trials, including recent
      reports, showed significantly lower clinical ongoing pregnancy rates in the antagonist group.
      Thus, additional efforts are needed to identify the optimal stimulation protocols to achieve
      better follicular and embryonic development and to improve the pregnancy rates in COH using
      GnRH antagonist.

      Given the assumption of a detrimental effect of GnRH antagonist on the pregnancy rate, with
      current protocols, we hypothesized that a shorter duration of GnRH antagonist administration
      might improve outcome.
    


Intervention name(s): cetrorelix acetate
Intervention type(s): Drug
Intervention description(s): The GnRH antagonist, cetrorelix acetate (Cetrotide; Serono) 0.25 mg was added daily, starting when the leading follicle reached 14 mm in diameter during ovarian stimulation for IVF. When the leading follicle reached a mean diameter of 18 mm or two follicles or more reached a diameter of 17 mm, 250 μg of recombinant hCG (Ovidrel; Serono) SQ was injected. In Group A, the GnRH antagonist continued to be used until the day of hCG administration. In Group B, the GnRH antagonist was not administrated on the hCG day
Intervention MeSH terms: Cetrorelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg
      in patients with type 2 diabetes.
    


Intervention name(s): sitagliptin phosphate; sitagliptin phosphate; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sitagliptin 100 mg tablets q.d. (once daily) for 7 days.; sitagliptin 200 mg tablets q.d. (once daily) for 7 days.; sitagliptin 100 mg & 200 mg matching Placebo tablets q.d. (once daily) for 7 days.
Other intervention name(s): MK0431; MK0431
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand
Condition: Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigational drug being studied in this protocol is Incobotulinumtoxin A (Xeomin®).
      Botulinum toxin (BoNT) prevents the release of the acetylcholine from peripheral nerves,
      inhibiting muscle contractions. BoNT is effective in relaxing overactive muscles. In
      musician's dystonia, the ability to reduce abnormally overactive muscles in the hand can be
      critical for the musical professional to continue his or her career. With the use of
      EMG/electrical stimulation and/or ultrasound guidance, the injector can precisely localize
      the individual muscles that are affected in this condition with great accuracy. Prior studies
      have shown that BoNT injections produce beneficial effects in forearm muscles, and less
      effect in shoulder or proximal arm muscles.

      Possible risks in treating patients with BoNT include excessive weakness of the injected
      muscles. The drug may also affect non-targeted muscles. However these risks will be minimized
      during the screening period by carefully targeting the affected muscles and by administering
      low doses of BoNT. Small booster doses may be given at follow up visit (2, 4, 14 and 16-weeks
      after the primary injection date) if the initial injection was insufficient to produce
      sufficient efficacy in relief of the focal dystonia and did not produce excess weakness of
      the targeted muscle.
    


Intervention name(s): incobotulinumtoxin A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Incobotulinumtoxin A is being used on average doses between 10U and 30 Units per subject, but at no time will any subject receive over 100 Units. Each study visit, the assessing physician will select the muscles and the amounts of medication to be injected.; matching placebo
Other intervention name(s): Xeomin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Musician's Dystonia
Oxandrolone in Healthy Adults: A Relative Bioavailability Study
Condition: Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetics and relative bioavailability of a single dose of approximately
      0.1 mg/kg of a medium chain triglyceride (MCT) oil oxandrolone solution vs. tablets in a
      small cohort of healthy adults.
    

Detailed description: 
      The results of this study will provide data regarding the relative bioavailability of a novel
      preparation of oxandrolone in MCT oil, which will allow dosing in neonates and small infants.
      This pilot study will provide information to design a larger multicenter study of neonates
      undergoing surgery for complex congenital heart disease.
    

Intervention name(s): Oxandrin
Intervention type(s): Drug
Intervention description(s): The primary outcome for this study will be measurements of the pharmacokinetics of a single dose of oxandrolone 0.1 mg/kg both in tablet form and in the MCT oil preparation. Blood samples for pharmacokinetics will be drawn at 9 timepoints.
Safety will be assessed by recording adverse events and assessment of hepatic function at baseline and one week following oxandrolone dosing.
Other intervention name(s): Oxandrolone
Intervention MeSH terms: Oxandrolone
Intervention model: Single Group Assignment
Intervention model description: Male
Age 18 to 35 years (inclusive) at the time of screening
Body mass index [BMI, body weight (kg)/height (m)2] below 30 kg/m2
Medically healthy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oxandrolone, cardiac
Women First: Preconception Maternal Nutrition
Condition: Maternal Malnutrition; Growth Failure; Mortality; Morbidity; Stunting
MeSH terms: Malnutrition; Failure to Thrive
Study type: Interventional

Summary: 
      Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain
      the benefits of ensuring optimal maternal nutrition before conception and providing an
      evidence base for programmatic priority directed to minimizing the risk of malnutrition in
      all females of reproductive age.
    

Detailed description: 
      The objective is to determine the benefits to the offspring of women in poor, food-insecure
      environments of commencing a daily comprehensive maternal nutrition supplement (with
      additional balanced calorie/protein supplement for underweight participants) ≥ 3 months prior
      to conception versus the benefits of commencing the same supplement at 12 weeks gestation and
      also to compare offspring outcomes with those of a control group which receives no
      supplement.
    

Intervention name(s): Comprehensive Maternal Nutrition Intervention
Intervention type(s): Dietary Supplement
Intervention description(s): The nutrition intervention will be delivered before conception or at 12 weeks gestation and continued through delivery and compared with a control group. The supplement to be used is a multi-micronutrient (MMN) fortified lipid-based supplement composed of dried skimmed milk, soybean and peanut extract, sugar, maltodextrin stabilizers, and emulsifiers.
Other intervention name(s): multi micronutrient (MMN) fortified lipid-based supplement; lipid-based nutrient supplement; LNS
Intervention MeSH terms: Micronutrients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: preconception maternal nutrition; LBW; Length-for-age; maternal nutrition supplement; multi-micronutrient fortified lipid-based supplement; infant growth; low-resource settings