bioihbjkbjnl/mcl2 huggingface dataset:
Low Dose Spinal Anesthesia in Cesarean Surgery
Condition: Maternal Hypotension; Anesthesia
MeSH terms: Hypotension
Study type: Observational [Patient Registry]

Summary: 
      Anesthesia for cesarean section requires special importance because it may affect both mother
      and the baby. To avoid maternal hypotension related to spinal anesthesia must be the primary
      objective during anesthesia. Even though many factors influence sensory nerve block for
      surgical anesthesia, local anesthetic dose is the main determinant. Another factor that
      influence the sensory nerve block is the obesity related to pregnancy. Due to the enlargement
      of epidural venous plexus related to pregnancy, the subarachnoid and epidural space reduces,
      so the local anesthetic requirement also reduces. Many investigators recommend lower dose of
      local anesthetic in obese patients due to reduced requirement There are many studies about
      dose regimens for cesarean anesthesia, but ideal dose have not been found. Investigators have
      designed this study to see the effects of conventional dose (10 mg bupivacaine) vs. low dose
      plus fentanyl (7,5 mg bupivacaine+25 mcg fentanyl) in obese and normal weight pregnant for
      cesarean section. The hypothesis was: the low dose regimen provides surgical anesthesia in
      obese patients while avoiding maternal hypotension.
    


Intervention name(s): Bupivacaine; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): To compare low dose spinal anesthesia with bupivacaine alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants; To compare low dose spinal anesthesia with bupivacaine+ fentanyl alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants
Other intervention name(s): Fentanyl; Bupivacaine
Intervention MeSH terms: Fentanyl; Bupivacaine
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing cesarean section under spinal anesthesia in obstetric clinic
      
Keywords: Spinal anesthesia; Cesarean; Maternal hypotension
Early Increase in Blood Supply in Patients With Barrett's Esophagus
Condition: Barrett's Esophagus
MeSH terms: Barrett Esophagus
Study type: Observational

Summary: 
      The purpose of this study is to determine if early Barrett's specialized intestinal
      metaplasia can be detected by measuring early increased blood supply of the esophageal
      tissue, with 4 Dimensional Elastic Light-Scattering Fingerprinting, (4D-ELF) technology in
      real time.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Control Population: Patients with no Barrett's metaplasia scheduled for upper endoscopy at
        Mayo Clinic Jacksonville.

        Experimental Population: Patients with biopsy-proven Barrett's esophagus and previously
        scheduled for upper endoscopy at Mayo Clinic Jacksonville.
Study of Intradermal Injections of RCS-01 in Male and Female Subjects
Condition: Intrinsic Aging of Skin; Skin Wrinkling; Solar Degeneration of Skin
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the safety profile of RCS-01 injections as
      compared to placebo injections. This study will also measure the impact these injections will
      have on skin markers related to aging through evaluation of gene expression profiles.

      30 participants will be selected for this study based on their health status, current/past
      medications, and ability to adhere to protocol-related requirements. At the first visit and
      after providing informed consent, participants are evaluated against the study
      inclusion/exclusion criteria and provide blood samples for screening assessments (including
      virology). If suitable for study participation, participants will provide a biopsy from the
      scalp from which RCS-01 will be prepared and will have four treatment evaluation sites
      identified on their buttocks, two on each side.

      Study participants will be randomized to one of two treatment subgroups. Participants in the
      RCS-01 Subgroup (n=24) will receive injections of RCS-01 or placebo or a 'sham' injection (a
      needle penetration without injection of liquid). Participants in the the Placebo Subgroup (n=
      6) will be randomized to receive only injections of placebo or sham injections.

      Baseline evaluations of subjects' overall health and skin condition at treatment sites on
      their buttocks will be performed before receipt of injections at Day 0. In addition to
      injections delivered at Day 0, the pre-selected treatment evaluation sites will receive
      intradermal injections of RCS-01 or placebo (cryomedium) or a sham injection four (4) and
      eight (8) weeks after Day 0 according to a randomization schedule for a total of three (3)
      injections per treatment site.

      All participants will return to the clinic for at least 9 visits during the 52-week follow-up
      period to monitor long-term safety. At the 12-week time point, 18 randomly-selected
      participants from the RCS-01 Subgroup will provide biopsies from all injection sites for
      analysis of skin markers related to aging. At the 26-week time point, the remaining
      participants will provide biopsies of all injection sites for histopathological analysis.
    


Intervention name(s): RCS-01; Placebo; Sham injection
Intervention type(s): Drug; Drug; Device
Intervention description(s): Cultured, autologous hair follicle cells suspended in cryomedium; Cryomedium; skin penetration of the needle without injection of liquid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Effect of Ultraviolet Radiation on Normal Skin (Photo-aging)
Platelet Rich Fibrin+1% Alendronate in Treatment of Mandibular Degree II Furcation Defects
Condition: Furcation Defects
MeSH terms: Furcation Defects
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the
      treatment of mandibular degree II furcation defects when compared with PRF and open flap
      debridement (OFD) alone.
    

Detailed description: 
      Background: Various regenerative materials have been introduced and tested in the treatment
      of furcation defects. Platelet-rich fibrin (PRF) is a reservoir of growth factors and
      cytokines which are the key factors for regeneration of bone and maturation of the soft
      tissue. Alendronate (ALN), a potent member of bisphosphonate group is known to promote tissue
      regeneration by inhibiting osteoclastic bone resorption and promoting osteoblastogenesis. The
      present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the
      treatment of mandibular degree II furcation defects when compared with PRF and open flap
      debridement (OFD) alone.

      Methods: Seventy two mandibular furcation defects were treated with either OFD alone (Group
      1), OFD with PRF (Group 2), and OFD with PRF+1% ALN (Group 3). Clinical parameters; site
      specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD),
      relative vertical attachment level (RVAL) and relative horizontal attachment level (RHAL),
      intrabony defect depth (IBD) were recorded at baseline before surgery and 9 months
      post-operatively. Percentage radiographic defect fill was evaluated at baseline and 9 months.
    

Intervention name(s): Open flap debridement (OFD); OFD with Platelet rich fibrin (PRF); OFD with Platelet rich fibrin (PRF)+1% Alendronate (Drug) in gel form
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Open flap debridement (OFD) alone; Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement; Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate gel placement
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Oxytocin and Attachment-related Interpretation Bias
Condition: Trust
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effects of oxytocin and a cognitive bias
      modification (CBM) procedure on children's trust in their mother.
    

Detailed description: 
      Previous research has shown that children can be trained to interpret ambiguous interactions
      with mother in a more secure way by use of a CBM procedure. A secure attachment-related
      processing bias can causally increase children's trust in mother's availability. The present
      study tests whether intranasal administration of oxytocin can increase the effect of a secure
      cognitive bias training. Oxytocin is a neuropeptide that is involved in human attachment and
      bonding. Intranasal administration of oxytocin can increase trust among people. After
      oxytocin or placebo administration, children are either trained to interpret ambiguous
      interactions with mother in a secure way or receive a neutral training unrelated to
      interpretation of maternal behavior. Pre- and post-intervention children's trust in mother,
      support seeking behavior and interpretation of maternal behavior is assessed. Moreover,
      possible oxytocin side-effects will be monitored.
    

Intervention name(s): Oxytocin; Placebo; Secure CBM training; Neutral CBM training
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): 40 IU/ML nasal spray. One administration: children <40kg administer 12IU, children >40kg administer 24IU.; NaCl 0,9 % nasal spray.; Children are trained to interpret ambiguous maternal behavior in a secure way.; Children receive a training unrelated to the interpretation of maternal behavior.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Attachment; Oxytocin; Cognitive bias modification; Middle childhood
Coping Skills Treatment for Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and
      acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation
      treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments,
      participants will receive one 60-minute individual session, seven 2-hour group sessions and
      two individual brief telephone contacts over an eight-week period. Both treatments include 8
      weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and
      will continue after the treatment sessions have ended. Participants will provide follow-up
      data with regard to their smoking status through a one-year follow-up period.
    

Detailed description: 
      1. 18-65 years of age,

        2. a regular smoker for at least one year,

        3. currently smoking 10 or more cigarettes per day,

        4. report motivation to quit smoking in the next month.
    

Intervention name(s): Transdermal Nicotine
Intervention type(s): Drug
Intervention description(s): Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.
Other intervention name(s): Nicoderm CQ
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cigarette smoking; smoking cessation; nicotine dependence
Effect of HIIT VS Yoga on Level of Pain, Catastrophizing and QoL in Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      This study is aimed at determining the effect of high intensity interval training VS yoga on
      pain, catastrophizing and quality of life among young females with dysmenorrhea.
    

Detailed description: 
      Dysmenorrhea is defined as a pain experienced by females before or during menstruation and it
      is a common and important gynecological condition found in females of reproductive age that
      adversely affects their quality of life. The cause of PD is believed to be the excess release
      of prostaglandins during normal ovulation cycle.

      The health care costs were altogether higher among females with dysmenorrhea compared with
      females who didn't experience the ill effects of this condition, and excess costs were
      essentially determined by outpatient care, so poses greater burden of disease than any other
      gynecological complaint. Females having more pain catastrophizing scores leads to increases
      chances of disability. Proper evidence behind HIIT training among females with primary
      dysmenorrhea is sparse and is based on different clinical experiences and a less number of
      studies with limited methodological design.
    

Intervention name(s): High intensity interval training; Yoga Training
Intervention type(s): Other; Other
Intervention description(s): HIIT 3 times a week for 8 weeks. For week 1 to 4 , Warm up 5 minutes jogging in place, 6 series of 30 seconds Burpees, 30 seconds recovery, 30 seconds skipping, 30 seconds recovery, 30 seconds lunge, 30 seconds recovery, 30 seconds 1-legged squats, 30 seconds recovery, 30 second leg levers, 30 seconds recovery. the series will have 3 minutes rest in between. Cool down of 10 minutes with gentle stretches.
For week 5 to 8 , Warm up 5 minutes jogging in place, 6 series of 45 seconds Burpees, 45 seconds recovery, 45 seconds skipping, 30 seconds recovery, 45 seconds lunge, 30 seconds recovery, 45 seconds 1-legged squats, 30 seconds recovery, 45 second leg levers, 30 seconds recovery. the series will have 3 minutes rest in between. Cool down of 10 minutes with gentle stretches.; Yoga 3 times a week for 8 weeks. 30-50 minutes session, 5 minutes breathing, 15-35 minutes yoga poses (Cat-cow, child's pose, downward dog, plank, Cobra), followed by 10 minutes supine meditation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: yoga; dysmenorrhea; Pain; catastrophizing; exercise
Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
Condition: Esotropia
MeSH terms: Esotropia
Study type: Observational

Summary: 
      To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy
      for infantile and acquired esotropia.
    

Detailed description: 
      Participants: 164 patients with infantile esotropia and 89 patients with acquired esotropia.

      Methods: Patients were injected with botulinum toxin into two medial rectus muscles and
      followed from 1992 to 2005. Patients were evaluated at 1 week, 2, 6 and 12 months, and then
      yearly post-injection.

      Main Outcome Measures: Degree of motor alignment, recurrence rate, incidence of stereopsis,
      and dissociated vertical deviation along with complications.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 373 patients with strabismus were treated with botulinum toxin injection by a
        single surgeon (AH Wang) at the Department of Ophthalmology, National Taiwan University
        Hospital, Taipei, Taiwan from 1992 to 2005.
      
Keywords: botulinum; esotropia
Effects of Fenofibrate on Adipocytokine Levels In Hypertriglyceridemic Patients
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Fenofibrate increases adiponectin levels, but reduces leptin levels
    


Intervention name(s): fenofibrate
Intervention type(s): Drug
Intervention MeSH terms: Fenofibrate
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: adipocytokines; insulin sensitivity; hypertriglyceridemic patients
Phytotherapy Strategy for Sleep Disorders Related to Anxiety With a Combination of Eschscholtzia and Valerian Extracts
Condition: Sleep Disorders Related to Anxiety
MeSH terms: Sleep Wake Disorders; Parasomnias; Anxiety Disorders
Study type: Observational

Summary: 
      The aim of the study is to evaluate the effect of a one-month supplementation with
      Phytostandard® Eschscholtzia and valerian on the Insomnia Severity Index (ISI), in insomniac
      so-called adjustment subjects (occasional or short-term insomnia)
    

Detailed description: 
      For this study, 40 patients are going to be included. They will have a supplementation of
      Phytostandard® Eschscholtzia and valerian, from 2 to 4 tablets per day during 28 days.

      on the one hand, during the two visits (inclusion and follow-up), the investigator completes
      the Hamilton Anxiety Scale (HAM-A). During the inclusion visit, he completes with his patient
      the epworth scale.

      on the other hand, patients complete ISI twice : just after the inclusion visit and just
      before the follow-up visit. He completes two sleep schedules, the first one during the first
      week of complement and the second one during the fourth.
    

Intervention name(s): Phytostandard® Eschscholtzia / Valerian
Intervention type(s): Dietary Supplement
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients suffering from sleep disorders linked to anxiety
The Role of Dopaminergic and Noradrenergic Neurotransmission in Value- and Salience-based Decision-Making
Condition: Healthy
Study type: Interventional

Summary: 
      Approach versus avoidance decisions are at the centre of adaptive behaviour and survival.
      These decisions are thought to be guided by the value of the choice options, which are a
      function of the magnitude of predicted rewards and punishments. Moreover, the allocation of
      attention to choice options is thought to be driven by salience, i.e. the overall importance
      of the predicted outcomes. While salience increases with the magnitude of both predicted
      rewards and predicted punishments, value increases with reward but decreases with punishment.
      In previous research, value and salience have often remained confounded during value-based
      decision making. Rodent research suggests that value is associated with dopamine and salience
      with norepinephrine. The present study aims at disentangling value from salience processing
      during decision-making tasks in healthy subjects by administering dopamine or noradrenaline
      reuptake inhibitors. This is done by using a single dose challenge in a randomized
      placebo-controlled between subject's design, administering either methylphenidate (35 mg),
      reboxetine (8 mg), or placebo to healthy young participants before they perform tasks tapping
      into various aspects of value and salience.
    


Intervention name(s): Methylphenidate; Reboxetine; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 35 mg methylphenidate (Ritalin®) is administered once using a randomized placebo-controlled between subject's design; 8 mg Reboxetine (Edronax®) is administered once using a randomized placebo-controlled between subject's design; A placebo pill is administered once using a randomized placebo-controlled between subject's design
Other intervention name(s): Ritalin®; Edronax®; Placebo Pill
Intervention MeSH terms: Methylphenidate; Reboxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators implement a randomized, double-blind, placebo-controlled between-subjects design, using one factor (pharmacological intervention) with three levels (reboxetine, methylphenidate and placebo).
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes
Condition: Diabetes; Hyperglycemia
MeSH terms: Diabetes Mellitus; Hyperglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      High blood glucose levels in hospitalized patients with diabetes are associated with
      increased risk of medical complications. Improved glucose control with insulin injections may
      improve clinical outcome and prevent some of the hospital complications. It is not known;
      however, what is the best insulin regimen in hospitalized patients. The use of repeated
      injections of regular insulin (known as sliding scale regimen) is one of the most commonly
      used insulin regimen for glucose control in hospitalized patients with diabetes. Recently,
      the combination of basal and rapid acting insulins has been shown to improve glucose control
      with lower rate of hypoglycemia (low blood sugar).
    

Detailed description: 
      This study will compare how well regular insulin will compare to glargine (Lantus®) once
      daily plus glulisine (Apidra®) insulin before meals in hospitalized patients with type 2
      diabetes and elevated blood glucose (sugar) levels. Lantus is a long-acting insulin which is
      given subcutaneously (under the skin) once daily. Apidra is a rapid-acting insulin which is
      given subcutaneously several times a day and frequently before meals. Regular insulin is a
      short-acting insulin in clinical use for more than 20 years that is also given subcutaneously
      several times per day. Lantus, Apidra and regular insulins are approved for use in the
      treatment of patients with diabetes by the FDA.

      This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta
      and at Jackson Memorial Hospital, Miami. Dr. Umpierrez designed the study and will serve as
      principal investigator. A total of 65 patients will be recruited at Grady and 65 patients at
      the Jackson Memorial Hospital. This study is supported by Sanofi-Aventis Pharmaceuticals.
    

Intervention name(s): sliding scale regular insulin; glargine basal insulin and glulisine prandial insulin
Intervention type(s): Drug; Drug
Intervention description(s): SSRI acqhs; glargine insulin once a day and glulisine insulin three times a day as long as patient eating
Other intervention name(s): Novolin-R; Lantus inuslin, Apidra insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inpatient; diabetes management; insulin therapy
Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument
Condition: Patient-Reported Outcomes (PRO)
Study type: Observational

Summary: 
      The purpose of this study is to conduct concept elicitation and cognitive debriefing
      interviews with patients who have been implanted with the KAMRA inlay in order to assess the
      content validity of a PRO instrument
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The sample recruited will reflect the target KAMRA inlay patient population. Thus, a
        minimum of 20 subjects (up to 50 subjects to achieve saturation) who have been implanted
        with the KAMRA inlay will be recruited from up to 5 sites across the US. Subjects with a
        range of post-operative experience, satisfaction, visual symptoms, ages and educational
        abilities will be recruited. In addition, subjects who are of non Caucasian ethnicity will
        be included.