bioihbjkbjnl/mcl2 huggingface dataset:
Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this research study is to investigate the effectiveness of a memory retraining
      program and a processing speed program in a spinal cord injured (SCI) population. The study
      is designed to research how well different types of techniques can help people with SCI
      improve in areas where they might have difficulties such as memory or processing speed, (time
      it takes to process information provided).
    

Detailed description: 
      The objectives of the currently proposed randomized clinical trial are to (1) apply a
      treatment protocol for Processing Speed and Learning and memory impairments, well-validated
      in other neurological populations, to individuals with SCI with objectively observable
      deficits in these areas and document efficacy on standard neuropsychological testing; (2)
      assess the effectiveness of the interventions in persons with SCI utilizing global measures
      of everyday life; (3) evaluate the long-term benefit of treatment. Prior to enrollment in the
      study protocol, all potential subjects will undergo a 2-part screening: (1) an initial
      screening examination via telephone during which basic information will be gathered and (2) a
      detailed, in-person screening that will be completed on if the subject passes the initial
      screen. Individuals must meet full screening criteria to be eligible for participation.
    

Intervention name(s): Behavorial; memory exercise; Placebo; memory exercise; Behavioral: speed exercises; Placebo speed training
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Memory training twice a week for 5 weeks.; Placebo Memory training twice a week for 5 weeks; Speed training twice a week for 5 weeks.; Placebo Speed training twice a week for 5 weeks.
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Multicentric Study an Endoscopic Treatment of Digestive Neoplasia by Submucosal Dissection Evaluation of a New Water Jet System
Condition: Stomach Neoplasm; Intestinal Neoplasm; Rectal Neoplasm
MeSH terms: Neoplasms; Stomach Neoplasms; Rectal Neoplasms; Intestinal Neoplasms
Study type: Interventional

Summary: 
      safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system
      is a new water jet system which allows to perform Endoscopic submucosal dissection with a
      bifunctional catheter (injection and cutting).
    

Detailed description: 
      Evaluation of the ability of this system to have a complete resection of superficial tumors
      of the digestive tract (that is to say a resection with free lateral and deep margins without
      residual tumor tissue)

      Evaluation of the ability of such system to inject a viscous macromolecular solution of
      glycerol (glycerol mix: Glycerol 10 %, Fructose 5 %, saline solution 0.9%)(27. Fujishiro M,
      Yahagi N, Kashimura K, et al. Comparison of various submucosal injection solutions for
      maintaining mucosal elevation during endoscopic mucosal resection. Endoscopy.
      2004;36:579-583.)
    

Intervention name(s): endoscopic sub-mucosal dissection
Intervention type(s): Procedure
Intervention description(s): endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oesophagus; stomach; intestine; rectum
Family Meals on Prescription- a Randomized Controlled Trial
Condition: Obesity, Childhood; Hypertension; Metabolic Syndrome; Dietary Habits
MeSH terms: Metabolic Syndrome; Pediatric Obesity
Study type: Interventional

Summary: 
      "Matkassen - effekten av tre månaders intensiv kostintervention hos barn med fetma/ Family
      Meals on Prescription.- a randomized controlled trial : The aim of the study was to explore a
      novel approach for the treatment of obesity in children and adolescents through an intensive
      dietary intervention, consisting of receiving a weekly bag of groceries and recipes for five
      family meals at a reduced price for three months.

      Data concerning dietary patterns and food habits, weight, BMI and blood markers for metabolic
      and cardiovascular disease was collected before the study began and again at the end of the
      study during the patients' one year follow up appointment at the clinics.
    

Detailed description: 
      Children between the age of 5-15 years receiving treatment for obesity at the pediatric
      clinics in Varberg and Kungsbacka were offered to participate in the trial.

      The study population was divided into two arms including 60 patients in each arm:

        -  In the first arm the patients received care consistent with regional guidelines.

        -  In the second arm the patients received care consistent with regional guidelines in
           combination with the intensive dietary intervention for three months.

      Data concerning dietary patterns and food habits, weight, BMI and blood markers for metabolic
      and cardiovascular disease was collected before the study began and again at the end of the
      study during the patients' one year follow up appointment at the clinics.
    

Intervention name(s): Dietary Intervention
Intervention type(s): Behavioral
Intervention description(s): See previous text
Dietary intervention consisiting och each family recieving foodpackages for 5 dinner meals during three months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible children where randomized to 1 of 2 interventional arms.
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and
      preliminary effectiveness of two blinded dose levels of telotristat etiprate (LX1606) in
      participants with acute, mild to moderate ulcerative colitis on 5-aminosalicylic
      acid/mesalamine therapy.
    


Intervention name(s): Telotristat Etiprate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg telotristat etiprate (LX1606) administered orally.; Matching placebo administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Recovery, Excretion and Pharmacokinetics of [14C]-GSK2140944 Administered as a Single Intravenous and Single Oral Dose to Healthy Adult Male Subjects
Condition: Infections, Respiratory Tract
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, non-randomized, two-period, cross-over, mass balance study that will
      evaluate the recovery, excretion, and pharmacokinetics of a single intravenous (IV) dose of
      [14C]-GSK2140944 (Period 1) and a single oral dose of [14C]-GSK2140944 ( Period 2) in 6
      healthy male subjects. The results from this study will aid in the design of future clinical
      pharmacology studies such as the thorough corrected QT interval study, special population
      studies (renal, hepatic, critically ill patients), potential drug interaction studies, and
      will help to establish safe and efficacious intravenous and oral dosing regimens.
    


Intervention name(s): GSK2140944 for Injection; GSK2140944 Capsule
Intervention type(s): Drug; Drug
Intervention description(s): GSK2140944 (1 gram) for Injection will be supplied as powder for injection containing [14C] GSK2140944. Non sterile powder is to be dissolved aseptically in sterile water for injection to a concentration of 4 mg/mL free base equivalent. IV solution is prepared by sterile filtration. 250 mL of IV solution, equivalent to 1000 mg GSK2140944, is then administered intravenously.; GSK2140944 Capsule (2 gram) will be supplied as powder in capsule containing [14C] GSK2140944. Powder is to be filled in empty capsule to achieve 200-400 mg strength per capsules as free base equivalent. Sufficient capsules are administered to provide the required total dose of 2 gram as free base.
Intervention MeSH terms: Gepotidacin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oral; ADME; IV; antibiotic; healthy volunteer; [14C]-GSK2140944; mass balance; radiolabel
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
Condition: HIV Infections; HIV Seronegativity
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and immune response of 100 mcg Env 2-3 antigen administered on days 0,
      30, 180, and 365.

      Preliminary immunologic data from protocol VEU 005B show evidence of the development of
      functional antibodies in the form of increased peptide binding and development of
      neutralizing antibodies. Evaluation of an antigen dose having potentially greater
      immunogenicity is therefore of particular interest.
    

Detailed description: 
      Preliminary immunologic data from protocol VEU 005B show evidence of the development of
      functional antibodies in the form of increased peptide binding and development of
      neutralizing antibodies. Evaluation of an antigen dose having potentially greater
      immunogenicity is therefore of particular interest.

      Twelve healthy volunteers receive injections of 100 mcg Env 2-3 in MF59 emulsion and two
      volunteers receive MF59 only on days 0, 30, 180, and 365. Follow-up continues for 6 months
      after the last injection.
    

Intervention name(s): Env 2-3
Intervention type(s): Biological
Allocation: Randomized
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Drug Evaluation; Adjuvants, Immunologic; AIDS Vaccines; HIV Preventive Vaccine
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted globally. The aim of the trial is to investigate efficacy and safety
      of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin
      degludec in children and adolescents with type 1 diabetes.
    


Intervention name(s): Faster-acting insulin aspart; insulin aspart; insulin degludec
Intervention type(s): Drug; Drug; Drug
Intervention description(s): For subcutaneous (s.c., under the skin) injection once daily.; For subcutaneous (s.c., under the skin) injection once daily.; For subcutaneous (s.c., under the skin) injection once daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b study involving multiple oral doses of AV-101 in healthy male and female
      subjects. The safety, pharmacokinetics, and antihyperalgesic effect of AV-101 on
      capsaicin-induced hyperalgesia will be assessed.
    

Detailed description: 
      Healthy subjects will be randomized into three dose cohorts (360, 1,080, and 1,440 mg) to
      receive daily oral doses of AV-101 for 14 consecutive days. Each cohort has 12 subjects on
      active drug and 4 subjects on placebo. Safety, PK, and antihyperalgesic effects of treatment
      with AV-101 will be assessed.

      At the screening visit between Day -28 and Day -7 before randomization, 250 μg of capsaicin
      will be intradermally delivered into the volar aspect of one forearm. Subjects must report a
      pain score of at least 4 out of 10 to qualify for the study. On Day 1 and Day 14 the
      following data are collected: (1) neurosensory testing (thermal sensation, thermal pain,
      touch, and mechanical pain) on the forearm; (2) neurocognitive evaluation; and (3) 12-lead
      electrocardiogram, blood pressure, heart rate, respiratory rate, and temperature. PK samples
      will be collected on Days 1, 2, 14, and 15. The capsaicin-induced pain will be assessed at
      screening, on Day 1, and Day 14. An intradermal injection of capsaicin into the forearm on
      Day 1 and Day 14 will be followed by the efficacy measures. On Day 1 before administration of
      the first dose, subjects will be given a paper diary to record daily self-administration of
      each dose, concomitant medications, and adverse events during the 14-day treatment period.
    

Intervention name(s): AV-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo or AV-101 at 360 mg, 1080 mg, or 1440 mg will be dosed once daily for 14 consecutive days.; Placebo or AV-101 at 360 mg, 1080 mg, or 1440 mg will be dosed once daily for 14 consecutive days.
Other intervention name(s): L-4-Cl-KYN; microcrystalline cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Neuropathic Pain; Capsaicin Induced Pain
Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control
Condition: Myopia; Accommodation
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to report the changes in accommodation, aberrations, and myopia
      in patients wearing multifocal soft contact lens for various durations.

      The study objectives are to:

        1. Determine the effects of wearing multifocal soft contact lens on accommodation and
           aberrations over a 12-month period.

        2. Determine the effect of wearing multifocal soft contact lens on myopia over a 12-month
           period.
    


Intervention name(s): Multifocal soft contact lenses
Intervention type(s): Device
Intervention description(s): Myopic subjects wore multifocal soft contact lenses for 12 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Pharmacokinetics of GSK1278863A Coadministered With a High Fat Meal or an Inhibitor of CYP2C8 (Gemfibrozil)
Condition: Anaemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Assess the Pharmacokinetics of GSK1278863A Coadministered with a High Fat Meal or an
      Inhibitor of CYP2C8 (gemfibrozil),]
    

Detailed description: 
      The purpose of this study is to assess the clinical drug-drug interaction potential of
      GSK1278863A with medications that are inhibitors of CYP2C8 enzyme in order to support
      co-administration of similar agents in later phase development. Specifically. this study will
      assess the pharmacokinetics of a single dose of GSK1278863A administered alone or
      co-administered with gemfibrozil, a potent inhibitor of CYP2C8, following steady-state oral
      administration of gemfibrozil. Finally, to support the co-administration of GSK1278863A with
      food, this study will assess the pharmacokinetics of a single oral dose of GSK1278863A under
      fasting conditions and following a standard high-calorie, high fat meal.
    

Intervention name(s): GSK1278863; GSK1278863 + food; Gemfibrozil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSk1278863 100mg; High Fat meal + 100 mg GSK1278863; 600 mg Gemfibrozil
Intervention MeSH terms: Gemfibrozil; Glycine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Anaemia; Drug- Drug Interaction
A Phase 1 Study To Evaluate the Safety of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV
      migalastat HCl alone and to determine absolute bioavailability for oral migalastat HCl as
      compared to IV administered migalastat HCl in healthy volunteers. The data from this study
      will help us understand how migalastat works in the body and will help us determine what
      would be an effective dose in future studies with migalastat hydrochloride.
    


Intervention name(s): IV migalastat HCl; IV placebo; oral migalastat HCl
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): AT1001; Sodium Chloride 0.9%; AT1001
Intervention MeSH terms: 1-Deoxynojirimycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fabry Disease; Fabry; Lysosomal storage disorders; LSD; Amicus; migalastat HCl; migalastat; AT1001
Aerobic Training, Aerobic-resistance Training and Glucose Profile (CGMS) in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Treatment; Exercise
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Many studies were already performed showing beneficial cardiovascular and metabolic effects
      of physical training for type 2 diabetic patients. However, glucose profile during and
      immediately after a short period of aerobic and/or resistance training was not studied yet.
      Continuous glucose monitoring system (CGMS) has now been added to the repertoire of
      technological devices useful in the management of patients with diabetes. Such monitoring
      enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable
      with intermittent testing of blood glucose. The main aim of the present study is to
      investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and
      ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2
      diabetic patients.
    

Detailed description: 
      Many studies were already performed showing beneficial cardiovascular and metabolic effects
      of physical training for type 2 diabetic patients. However, glucose profile during and
      immediately after a short period of aerobic and/or resistance training was not studied yet.
      Continuous glucose monitoring system (CGMS) has now been added to the repertoire of
      technological devices useful in the management of patients with diabetes. Such monitoring
      enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable
      with intermittent testing of blood glucose. The main aim of the present study is to
      investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and
      ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2
      diabetic patients.
    

Intervention name(s): Acute aerobic exercise; Acute aerobic-resistance exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Aerobic exercise (on a cycle ergometer, for 50 min); Aerobic-resistance exercise (on a cycle ergometer plus strength training, for 50 min in total)
Other intervention name(s): There are no other names; There are no other names
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus; Exercise; Endurance; Resistance; Continuous glucose monitoring system
A Single Ascending Dose Study of Safety and Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I, randomized, double-blinded, placebo-controlled, single ascending dose study to
      investigate the safety, local tolerability and transformation of nucleus pulposus following
      intradiscal injection of STA363 or placebo in patients with discogenic low back pain.

      15 patients will participate in either of 3 dose groups, each comprising 5 patients:

        -  Group 1: STA363 dose 1 (3 patients) or placebo (2 patients)

        -  Group 2: STA363 dose 2 (3 patients) or placebo (2 patients)

        -  Group 3: STA363 dose 3 (3 patients) or placebo (2 patients)
    


Intervention name(s): STA363; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection.; Matching placebo solution with identical appearance to the test product, used as reference treatment. Administered as intradiscal injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Following treatment of 2 patients in each dose group (injections with active drug and placebo, respectively), safety data will be reviewed. If no safety or tolerability concerns are identified, the next 3 patients in each dose group will be treated (active treatment or placebo [2:1]).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Homeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosis
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the effect of homeopathy as an adjuvant to Anti
      tuberculosis treatment on sputum conversion, hematological, clinical sign and symptoms of
      relapsed Pulmonary TB.
    


Intervention name(s): Anti-Tuberculosis Treatment
Intervention type(s): Drug
Other intervention name(s): DOT CAT II
Intervention MeSH terms: Antitubercular Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
Condition: Parkinson Disease; Dyskinesias
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase IIb study is designed to determine the safe and efficacious dose or dose range of
      AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa
      induced dyskinesias.
    


Intervention name(s): AFQ056; AFQ056; AFQ056; AFQ056; AFQ056; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson Disease; L-dopa; Levodopa; dyskinesia