bioihbjkbjnl/mcl2 huggingface dataset:
Intravenous Dexmedetomidine in Cesarean Section Under Spinal Anesthesia
Condition: Cesarean Section Complications
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study hypothesized that intravenous dexmedetomidine use during spinal anesthesia
      for cesarean section has a beneficial influence on hemodynamic stability and epigastric pain
      together with satisfactory analgesic effects and excellent safety profile for the mother and
      the newborn.
    

Detailed description: 
      Background and aim: Hypotension and epigastric pain are commonly encountered during spinal
      anesthesia for cesarean section. Dexmedetomidine (DEX) is a highly selective α 2-adrenergic
      agonist. Its effects entail sympatholytic, sedative, anesthetic, and analgesic actions. The
      present randomized study aimed to evaluate the effect of intravenous DEX administration on
      the hemodynamic parameters and epigastric pain in women subjected to cesarean section.

      Patients and Methods: This study is a randomized double-blinded controlled trial. Seventy
      patients were randomly assigned to one of two interventional groups: one group received
      spinal anesthesia and intravenous DEX (1µg/kg) and the other group received spinal anesthesia
      and placebo (saline). The administrated drugs were slowly injected intravenously over 10
      minutes then intrathecal block was achieved using 2-2.2 ml of hyperbaric bupivacaine (10
      -12.5 mg) introduced at L3/4 or L4/5 interspace. Primary Outcome parameters included
      frequency of hypotension episodes, frequency of ephedrine doses needed, sedation score and
      epigastric pain episodes. Secondary outcomes included time to onset of sensory and motor
      blocks, duration of sensory and motor blocks, operative duration, time needed to request of
      rescue analgesia, level of intrathecal block, and neonatal Apgar score at 1 and 5 minutes.
    

Intervention name(s): Dexmedetomidine Injectable Product; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Spinal anesthesia and intravenous dexmedetomidine (1μg/kg). The administrated drugs were slowly injected intravenously over 10 minutes then intrathecal block was achieved using 2-2.2 ml of hyperbaric bupivacaine (10 -12.5 mg) introduced at L3/4 or L4/5 interspace.; Spinal anesthesia and intravenous saline. The administrated drugs were slowly injected intravenously over 10 minutes then intrathecal block was achieved using 2-2.2 ml of hyperbaric bupivacaine (10 -12.5 mg) introduced at L3/4 or L4/5 interspace.
Other intervention name(s): Precedex; saline solution
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: dexmedetomidine; spinal anesthesia; cesarean section; epigastric pain
Intra-individual Variability and Circadian Rhythm of VEGF Levels and Interaction With Biomarkers
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema
Study type: Observational

Summary: 
      The study evaluates the intra-individual variability of VEGF levels over a period of 6 months
      as well as the circadian variation of VEGF levels, both under standardized conditions in
      patients with type 2 diabetes without DME and matched subjects with normal glucose tolerance
      (NGT). Secondary objectives of the study are to evaluate the relationship of individual
      VEGF-levels to biomarkers of inflammation, HbA1c and major cardiovascular risk factors.
    


Intervention name(s): Frequent blood and urine sampling and blood pressure measurement
Intervention type(s): Other
Intervention description(s): Blood and urine sampling for the determination of VEGF and biomarkers
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Community sample of healthy volunteers, type 2 diabetes patients of the study center
Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation
Condition: End Stage Renal Disease; Kidney Disease, Chronic
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a telemedicine follow-up visit at the NYU
      Langone Transplant Institute is a feasible and acceptable alternative to a traditional
      in-center follow-up visit.
    

Detailed description: 
      A six-month prospective randomized-controlled clinical pilot study to evaluate a new
      intervention for the transplant program: telemedicine (TM) visits. Researchers will target
      patients on the transplant waiting list who are currently undergoing dialysis. Currently,
      there are 234 patients on the transplant waiting list who receiving care at dialysis centers
      in the New York City area. Researchers will select the 10 dialysis centers having the highest
      number of patients on the transplant list in order to yield a target sample of 45.

      Eligible participants will be randomized to 1 of 2 groups: (1) usual care (UC) which is the
      routine 6-month follow up appointment at the NYULMC transplant center or (2) TM visit
      conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit.
      Patients will be followed for 4 months post randomization to determine the number of days
      that elapse between randomization and routine transplant evaluation. As new clinic
      appointments are currently experiencing 80-day wait, a 4-month follow-up should be more than
      adequate to evaluate this primary outcome.

      The intervention will be evaluated primarily in terms of efficiency, and secondarily in terms
      of patient/physician experiences, changes in waiting list status, and referral for living
      donation.
    

Intervention name(s): Usual Care Visit; Telemedicine Visit
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Routine 6-month follow up appointment at the NYULMC transplant center; TM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Telemedicine
High-risk Obstetrical Patient Intervention Utilizing the Contraceptive CHOICE Project Script
Condition: Diabetes; Contraception
Study type: Interventional

Summary: 
      High-risk obstetrical patient Intervention to promote Birth Interval Spacing utilizing the
      Contraceptive CHOICE project script to reduce Unintended Subsequent pregnancies (HIBISCUS) is
      a collaborative study utilizing qualitative methods to assess the acceptability including a
      family planning specialist's postpartum contraception counseling during and after prenatal
      care among Latina obstetric women with pre-gestational diabetes. The investigators will
      compare the effectiveness of HIBISCUS versus usual contraceptive counseling on Long-Acting
      Reversible Contraception (LARC) use at 3 months postpartum.
    

Detailed description: 
      The purpose of this research is to address this gap in long-acting reversible contraception
      (LARC) counseling among Latinas who have pregnancies complicated by pre-gestational diabetes
      in order to promote optimal birth-to-pregnancy spacing and planned pregnancies with optimal
      glucose control. The investigators will utilize Contraceptive CHOICE project which was LARC
      focused counseling script and removed the cost of contraception. This study had a LARC
      utilization of 75% compared to the national use of LARC of 7.2% The investigators will
      conduct a pilot randomized controlled trial among Latina obstetrics patients with
      pre-gestational diabetes involving a prenatal and postpartum visit with a family planning
      specialist versus usual contraceptive counseling. The family planning specialist counseling
      will utilize the Contraceptive CHOICE Project script promoting LARC, 18 month
      birth-to-pregnancy recommendation and preconception counseling. The intervention's name is
      HIBISCUS.
    

Intervention name(s): HIBISCUS counseling
Intervention type(s): Other
Intervention description(s): Third trimester prenatal appointment with a family planning specialist for contraceptive counseling utilizing the Contraceptive CHOICE counseling script - emphasizing the WHO birth-to-pregnancy recommendation of 18 months, and a follow up postpartum contraception visit with a family planning specialist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Contraception; Prenatal Counseling
Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the
      long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649
      in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's
      Disease.
    

Detailed description: 
      As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at
      Week 51, in patients diagnosed with EDS in Parkinson's Disease.
    

Intervention name(s): BF2.649 (Pitolisant)
Intervention type(s): Drug
Intervention description(s): 1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D
Other intervention name(s): Pitolisant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Excessive Daytime Sleepiness (EDS); Parkinson's Disease
Pharmacokinetic of Levodopa Study in Healthy Males
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate PK of levodopa in plasma after repeated doses of 3
      levodopa formulations given in combination with carbidopa and ODM-104 and compared to the PK
      of standard IR and CR levodopa formulations in the same combination.
    


Intervention name(s): Levodopa, carbidopa, ODM-104
Intervention type(s): Drug
Intervention description(s): Crossover design. Study treatments will be administered in randomized order 4 times a day.
Other intervention name(s): Sinemet
Intervention MeSH terms: Levodopa; Carbidopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare pharmacokinetics between fixed-dose combination and
      separate combination of clopidogrel 75mg/aspirin 100mg.
    


Intervention name(s): Clopidogrel; Fixed dose combination of clopidogrel/Aspirin; Aspirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clopidogrel and Aspirin separate combination, single dose; Fixed dose combination of clopidogrel/aspirin
Other intervention name(s): Clopidogrel: Plavix; Coprigrel; Aspirin: Astrix
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clopidogrel; Aspirin; Combination; Pharmacokinetics; Phase 1
Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hypertension; Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to measure the effect of the amlodipine/atorvastatin combination
      pill in reducing both elevated blood pressure and cholesterol levels to levels suggested by
      guidelines
    


Intervention name(s): Amlodipine/atorvastatin single pill
Intervention type(s): Drug
Intervention MeSH terms: Amlodipine; Amlodipine, atorvastatin drug combination; Atorvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate
      Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus
    


Intervention name(s): PHX1149T; PHX1149T; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 mg; 400 mg; Placebo
Other intervention name(s): dutogliptin; dutogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dutogliptin; PHX1149; DPP4 inhibitor
Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects From 6 Months to 17 Years of Age
Condition: Pandemic Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate
      immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new
      swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and
      adolescents. A booster dose will be administered 12 months after the first vaccination.
    


Intervention name(s): Monovalent A/H1N1 influenza vaccine
Intervention type(s): Biological
Intervention description(s): This trial will be performed at multiple study sites in a population of healthy children and adolescent. Subjects will be randomized to receive 2 IM injections of low dose of antigen & adjuvant, or high dose of antigen & adjuvant, or high dose of antigen, according to the study groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Pandemic influenza; Vaccine
Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes
      patients receiving vildagliptin as add-on therapy to metformin
    


Intervention name(s): Vildagliptin; Metformin; Placebo; Sitagliptin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; vildagliptin
Dry Needling in Subjects With Delayed Onset Muscle Soreness
Condition: Delayed Onset Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      Investigation of the biomechanical response in delayed onset muscle soreness using dry
      needling vs. sham
    


Intervention name(s): Dry needling; Sham needling
Intervention type(s): Other; Other
Intervention description(s): The use of a solid filiform needle to treat trigger points; Simulated needling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Varenicline on Reward Responses and Cognition in Adolescent Smokers
Condition: Tobacco Use Disorders
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot project using functional magnetic resonance imaging (fMRI) to examine the
      influence of varenicline on reward processing, cognitive control, and regulation of craving
      in adolescent smokers. We hypothesize that adolescent smokers receiving varenicline, when
      compared with those receiving placebo, will have differential brain responses to anticipation
      of rewards, during exposure to the Stroop task, and in response to tobacco cues.
    

Detailed description: 
      This is a pilot project using functional magnetic resonance imaging (fMRI) to examine the
      influence of varenicline on reward processing, cognitive control, and regulation of craving
      in adolescent smokers. We hypothesize that adolescent smokers receiving varenicline, when
      compared with those receiving placebo, will have increased activation of the ventral striatum
      (VS) in response to anticipation of rewards in the Monetary Incentive Delay Task (MIDT),
      decreased activation of the dorsolateral prefrontal cortex (dlPFC) during exposure to
      incongruent stimuli in the Stroop task, and reduced activation of the ventral striatum in
      response to tobacco cues, and increased activation of the dlPFC during regulation of
      responses to tobacco cues during the Regulation of Craving (ROC) task. The results of this
      pilot project will have important implications regarding the use of varenicline for treating
      tobacco dependence and understanding varenicline's neurobiological effects in adolescent
      smokers.
    

Intervention name(s): Varenicline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg bid varenicline titrated over a 2 week period; 1 mg bid placebo titrated over a 2 week period
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Tobacco; Adolescent; Nicotine; Magnetic Resonance Imaging; Varenicline
Plyometric Work Together With the Use of Ballast Weight in Lower Limbs in the Improvement of Performance in Jumpers
Condition: Athletes
Study type: Interventional

Summary: 
      Introduction. The high jump is a discipline that use the shortening-stretching cycle.
      Plyometric exersices emply an eccentric load followed by concentric contraction. Powerinstep
      is a tool training by means of weigthed weigth whose objective is improving performance in
      athletes.

      Aim. Evaluate efficacy of plyometric training with Powerinstep® in lower limbs, in the
      performance improvement in professional height jumpers from 18 to 40 years old.

      Study design. Non-randomized clinical trial, single bind, with follow-up period.

      Methods. 20 athletes will be recruited, that will be randomized to the two study groups:
      experimental (they carry out a plyometric training programme with Powerinstep) and control
      (won't be made a intervention on the subjects included in this group). The intervention
      consists of 6 week, with 2 session for week of 15 minutes duration each. The dependent
      variables will be the height of the jump, the time of flight, the reaction speed and the
      impulse force, measures though a pressure platform (model T-PLATE), employing Countermovement
      Jump, Abalakov and Drop Jump tests. We will make a descriptive statistical analysis. The
      Shapiro-Wilk statistical test will be used to calculate normality. Trough t-student test of
      repeated measures and an ANOVA of repeated measures will be calculated the difference between
      distinct assessment (preintervention, postintervention and follow-up) and the effect intra
      and inter subject, respectively.

      Expected results. We want to observe the changes in performance improvement in height
      jumpers.
    


Intervention name(s): Plyometric exercises
Intervention type(s): Other
Intervention description(s): Jump Drop Jump, dropping the subject from a height of 30cm and then make a vertical jump.
Long jumps asking the athletes to take momentum and make a leap forward trying to reach the greatest possible distance.
Jump Countermovement jump unilaterally, alternating the lower extremities. Jumps 180º with the athletes maintaining a semi-squat position. Jump Countermovement jump repeatedly starting from an upright position and the upper extremities in both hips.
All the exercises will be done through 8 repetitions per session during the first two weeks, increasing two repetitions every two weeks (until reaching 12 repetitions at the end of the intervention).
For the realization of each one of the exercises, the ballasted weight will be used (Powerinstep® model).
Other intervention name(s): Plyometric training programme with Powerinstep
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Jump; Plyometrics; Training; Performance; Powerinstep; Non-randomized clinical trial
Juvenile Primary Fibromyalgia Syndrome (JPFS) in an Adolescent Psychiatric Population
Condition: Juvenile Primary Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study was to identify clinical characteristics and estimate the
      prevalence of Juvenile Primary Fibromyalgia in a female inpatient psychiatric population. The
      secondary purpose of this study was to determine the efficacy of an intervention
      (psychoeducational seminar and relaxation technique) on reducing the symptoms of Juvenile
      Primary Fibromyalgia Syndrome. We looked at the short-term and long-term effects of this
      intervention in comparison to the control (skin care seminar).
    

Detailed description: 
      The specific aims of phase one of this study were to estimate the prevalence of Juvenile
      Primary Fibromyalgia Syndrome (JPFS) in an inpatient female psychiatric population and to
      identify characteristics associated with JPFS in this population. We chose to explore two
      primary hypotheses. Because of the common link between adult fibromyalgia and anxiety and
      depression, we hypothesize that those with JPFS will score higher on measures of these
      symptoms. Given the adult literature on the suspected link between physical and or sexual
      abuse and adult fibromyalgia, we also hypothesized that adolescents who meet criteria for
      JPFS will have higher rates of sexual and physical abuse.

      The other specific aim of this study was to determine the short- and long-term impact of an
      intervention on reduction of JPFS symptoms. The intervention was a psychoeducational seminar
      on JPFS (pain management, diet, exercise and sleep hygiene) followed by a relaxation
      technique (audio-guided CD). The control group was involved in an educational seminar on skin
      care (WITHOUT relaxation technique). Study measures were obtained immediately before and
      after the intervention/control seminars (short-term) and 8 weeks after discharge (long-term).
      Each group was discharged with a CD player and CD with relaxation technique or skin care
      seminar. Participants recorded the use of the CD's and completed follow up questionnaires 8
      weeks after discharge from the hospital.
    

Intervention name(s): Psychoeducational Seminar and Relaxation Technique
Intervention type(s): Behavioral
Intervention description(s): Psychoeducational seminar on Juvenile Primary Fibromyalgia (pain management, diet, exercise and sleep hygiene) followed by a total body relaxation technique
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Juvenile Primary Fibromyalgia; Adolescents; Psychiatry