bioihbjkbjnl/mcl2 huggingface dataset:
Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in
      speech and communication, impaired social functioning and repetitive behaviors and restricted
      interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating
      uterine contractions and milk let-down; however, studies, mainly with rodents and non-human
      primates, has found that OT is involved in affiliative behaviors, including sexual behavior,
      mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of
      social attachment. Moreover, OT is known to play an important role in repetitive behaviors
      and stress reactivity. Given that repetitive behaviors and deficits in social interaction are
      core symptom domains of autism, and that OT is involved in the regulation of repetitive and
      affiliative behaviors, it is believed that OT may play a role in the etiology of autism.
      Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of
      value in treating core autism symptoms. Specifically, synthetic oxytocin administered via
      intravenous infusion to adults with autism spectrum disorders (ASD) produced significant
      reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind,
      placebo-controlled cross-over laboratory challenge.

      Encouraged by these findings, the primary aim of this study is to investigate the safety and
      therapeutic efficacy of intranasal OT in treating repetitive behaviors and social
      functioning/cognitive deficits in adults with ASD. This research embraces a translational
      approach to develop a novel treatment for core ASD symptoms; given that there are currently
      no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms,
      this research addresses an important unmet need in the field. The goal of this study is to
      evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment
      (INOT)administration in adults with ASD.
    


Intervention name(s): Intranasal Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oxytocin administered intranasally twice a day via 1 12 unit puff to each nostril, totaling 48 IU a day.; Saline will be administered intranasally twice a day via 1 puff per nostril, totaling 48 IU a day.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Autism Spectrum Disorders; Oxytocin; Hollander; ASD; Asperger Syndrome; Asperger
SB-681323-Methotrexate Interaction Study
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      SB-681323 is a p38 MAP-kinase inhibitor that has potential uses in inflammatory conditions
      such as RA. Previous p38 MAP-kinase inhibitors have been hindered in development by liver
      toxicity. Methotrexate (common treatment for RA patients) also has potential liver toxicity.
      This study was an enabling study to determine the safety of co-administration of the two
      compounds with respect to liver function
    


Intervention name(s): SB-681323 oral tablets
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: methotrexate,; SB-681323,; p38 MAP Kinase Inhibitor,; liver function; Rheumatoid Arthritis,
The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine
Condition: Spinal Anesthesia
Study type: Interventional

Summary: 
      Intrathecal epinephrine has been known to increase the duration of spinal anesthesia, or
      increase the quality of anesthesia. However, there is still a controversy, and the mechanism
      of epinephrine is recently suggested as a modulator of pain information in the spinal cord.
      Therefore, the investigators try to investigate the dose sparing effect of intrathecal
      epinephrine for spinal anesthesia with bupivacaine.
    

Detailed description: 
      For patient undergoing total knee replacement arthroplasty, patients injected intrathecally
      with bupivacaine 8 mg were compared with those with bupivacaine 8 mg with 25 mcg of
      epinephrine, bupivacaine 8 mg with 50 mcg of epinephrine, and those with bupivacaine 8 mg
      with 100 mcg of epinephrine. The investigators compared the characteristics of spinal
      anesthesia including the quality and complication of spinal anesthesia. The researchers
      investigated whether intrathecal dose of epinephrine can reduce bupivacaine requirement and
      this effect is dependent on the dose of epinephrine.
    

Intervention name(s): Placebo; epinephrine 25; Epinephrine 50; epinephrine 100; Epi 200
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): intrathecal 8 mg of bupivacaine only; intrathecal 8 mg of bupivacaine mixed with 25 mcg of epinephrine; intrathecal 8 mg of bupivacaine mixed with 50 mcg of epinephrine; intrathecal 8 mg of bupivacaine mixed with 0.1 mg of epinephrine; intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
Other intervention name(s): Epinephrine; Epinephrine; Epinephrine; Epinephrine; epinephrine
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: intrathecal epinephrine; duration of anesthesia; quality of anesthesia; intrathecal fentanyl
Nutraceutical Supplement With Vegan Botanicals in Females With Self-Perceived Thinning Hair
Condition: Hair Thinning
MeSH terms: Alopecia; Alopecia Areata; Hypotrichosis
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of a vegan nutraceutical
      supplement with standardized botanicals in females leading a more plant-based lifestyle with
      self-perceived thinning hair
    

Detailed description: 
      Hair loss is a common condition affecting both men and women that is more recently understood
      to be the result of multiple causes. Although it is generally a benign condition, hair loss
      can have a significant, detrimental impact on self-esteem, psychosocial functioning and the
      overall quality of life of affected individuals. It can also represent a substantial
      financial burden on individuals seeking treatment.

      This is a 6-month, multi-center, single-arm prospective interventional study in adult female
      subjects who follow a plant-based diet with self-perceived hair thinning as confirmed by a
      dermatologist. The objective of this study is to assess the efficacy and safety of novel
      women's vegan supplement for hair growth.
    

Intervention name(s): Nutrafol Vegan Women's Hair Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Nutrafol's Vegan Women's Hair Supplement with patented Synergen Complex® is a blend of proprietary formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. These ingredients include Sensoril Ashwagandha, Curcumin, Saw Palmetto, 20% Tocotrienol/Tocopherol complex, and capsaicin in combination with other vegan nutrients used to support hair health such as Pea Sprout Extract, Bamboo, and a new innovative Maldavian Dragonhead flower extract.
Intervention model: Single Group Assignment
Intervention model description: 6-month, multi-center, single-arm prospective interventional study
Masking: None (Open Label)
Primary purpose: Treatment
Acceptability Study of a New Fixed Combination of Fenofibrate 80 mg BID and Metformin 1000 mg BID in Type 2 Diabetes and Dyslipidemia
Condition: Diabetes Mellitus, Type 2; Dyslipidemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study aims to assess the acceptability of a 4 week treatment of a new fixed-dose
      combination of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia
    


Intervention name(s): Fenofibrate 80 mg and metformin 1000 mg (fixed combination)
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Fenofibrate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type II diabetes; dyslipidemia; metformin; fenofibrate; synordia
A Trial of SHR-1703 in Healthy Adults
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      SHR-1703 is a monoclonal antibody under development for severe asthma. This study is the
      first study in Healthy subjects. The purpose of this study is to evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of a single dose SHR-1703 administered
      subcutaneously in Chinese healthy subjects.
    

Detailed description: 
      This study will be conducted at 1 study center in China. Approximately 42 healthy Chinese
      male and female subjects, aged 18 to 55 inclusive, will be randomized to receive a single SC
      administration of SHR-1703: Treatment 1, Treatment 2, Treatment 3, Treatment 4 and Treatment
      5. Each subject will participate in only 1 treatment group. The total length of the study for
      each subject is up to 190 days (28 days of screening and 155+/- 7 days of further study
      visits).
    

Intervention name(s): SHR-1703; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SHR-1703; Placebo of the SHR-1703
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mouth Breathing Habits Improvement Intervention
Condition: OSA
MeSH terms: Mouth Breathing
Study type: Interventional

Summary: 
      This study intends to investigate the improvement in patients with OSA through objective
      measurement, including oxygen desaturation index (ODI) and the percentage reduction in
      intermittent mouth puffing (IMP) before and after the intervention. The oral appliances are
      placed between the tongue and the soft palate to reduce the oral ventilation space. A total
      of 24 participants aged between 36 and 57 years were identified with ODI above 5 events/hour
      by measuring their blood oxygen and with an originally designed mouth puffing detector to
      find out those who were still mouth-puffed when their mouths were taped. A suitable appliance
      was chosen for the participants between the two originally designed oral appliances, tongue
      pressed device (TPD) and tongue elevated device (TED), and the intervention lasted for six
      weeks.
    


Intervention name(s): Oral Appliances
Intervention type(s): Other
Intervention description(s): A pre-experimental, single-group pretest-posttest design was performed. At stage one, each participant underwent a 2-day general sleeping test and a 2-day sleeping test with mouth tape. At stage two, participants underwent conventional impressions for TPD and TED appliances and were then randomly assigned to wear the TPD or TED; together for two days of sleeping test with their mouth taped. After a 2-day break (washout), with the same procedure, participants wore the other appliance for another 2-day sleeping test and decided accordingly the optimal appliance that had reduced their ODI scores more. At stage three, participants wore their optimal appliance mouth-taped during sleep for 6 weeks. At the end of the intervention, all participants underwent few days sleeping test for final results.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: mouth breathing; mouth puffing; sleep apnea; oral appliance
Dissection of the Gastrointestinal-mediated Glucose Disposal and Incretin Defect in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In patients with type 2 diabetes, the incretin effect is markedly reduced contributing to the
      relative insulin deficiency that characterizes these patients. This defect is believed to be
      due to a decreased effect of GLP-1 and an almost ceased effect of GIP. Nevertheless, the
      impact of the defect on glucose tolerance is not fully understood. The so-called
      gastrointestinal-mediated glucose disposal (GIGD) is a measure of glucose handling, which
      includes the incretin effect, but also other factors affecting glucose disposal (e.g.
      glucagon secretion). Interestingly, patients with type 2 diabetes exhibit elevated plasma
      glucagon levels in the fasting state, and glucagon concentrations fail to decrease
      appropriately and may even increase in response to ingestion of glucose and show exaggerated
      increases after a mixed meal. With the current project the investigators wish to elucidate
      how this paradoxical glucagon response observed in patients with type 2 diabetes affects the
      GIGD, the incretin effect and postprandial glucose excursions.

      Ten patients with type 2 diabetes and 10 healthy matched control subjects will be enrolled in
      this randomised, placebo-controlled, double-blinded study. The aim is to examine the effect
      of a glucagon receptor antagonist (GRA) on gastrointestinal-mediated glucose disposal (GIGD),
      incretin effect and postprandial glucose excursions in patients with type 2 diabetes and
      healthy controls. Participants will attend two oral glucose tolerance tests (OGTT), two
      isoglycaemic iv glucose infusion (IIGI) and two standardised liquid meals.
    


Intervention name(s): LY2409021; LY2409021 placebo; OGTT; IIGI; Standardised liquid meal
Intervention type(s): Drug; Drug; Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Treatment of Nonalcoholic Fatty Liver Disease With Probiotics and Prebiotics
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The investigators' aim is to determine whether probiotic and prebiotic treatment plus
      lifestyle advice is more effective in reducing hepatic fat content than lifestyle advice
      alone in patients with Nonalcoholic Fatty Liver Disease (NAFLD).
    


Intervention name(s): Lepicol probiotic & prebiotic formula; Simple lifestyle advice
Intervention type(s): Drug; Other
Intervention description(s): NAFLD patients treated with Lepicol probiotic and prebiotic formula for 24 weeks.; NAFLD patients treated with lifestyle advice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Nephronic Reduction After Neonatal Acute Renal Failure in Preterm
Condition: Neonatal Acute Renal Failure in Preterm
MeSH terms: Premature Birth; Renal Insufficiency; Acute Kidney Injury
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the signs of nephronic reduction in preterm infants who
      have presented neonatal acute renal failure. The investigators hypothesize that signs of
      nephronic reduction would appear earlier in former preterm with neonatal acute renal failure
      than in control preterm infants.
    

Detailed description: 
      50 former preterm infants who presented acute renal failure will be evaluated between 3 to 10
      years.

      They will be compared to 25 control former preterm infants without renal dysfunction for
      signs of nephronic reduction.

      At inclusion, in order to analyse renal function, all infants will have blood sampling, renal
      echography and blood pressure measurement. Urine sample will also be collected.

      Two months later, parents will be informed on the results.
    

Intervention name(s): renal echography; Blood sampling; collection of an urine sample; Blood pressure measurement
Intervention type(s): Other; Other; Other; Other
Intervention description(s): renal echography to analyse the kidney; Blood sampling to analyse different parameters of renal function; Collection of an urine sample to perform analysis of renal function parameters
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: preterm infants; acute renal failure; nephronic reduction
Babies' Expectations About Racial Interactions
Condition: Infant Behavior
Study type: Interventional

Summary: 
      This study will examine whether infants view race as an inductively useful social cue to
      predict third-party social relationships.
    

Detailed description: 
      Based on findings that infants expect more affiliation between same language speakers than
      different language speakers (i.e., infants will look longer at affiliation between different
      language speakers than same language speakers), this study will assess whether infants'
      expectations about intra- and inter-racial interactions will also follow the same pattern as
      language. After informed consent, participants who meet the eligibility requirements will be
      randomized into one of the 3 conditions: Watching (1) two White adults affiliating and
      disengaging, (2) two Black adults affiliating and disengaging, and (3) one White and one
      Black adults affiliating and disengaging.
    

Intervention name(s): Basic Science
Intervention type(s): Other
Intervention description(s): This is a basic science experiment to test whether infants' looking time to video stimuli differ according to the race of the individuals shown.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Recurrence and Pregnancy Post-repair of Obstetric Fistula in Guinea
Condition: Fistula
MeSH terms: Recurrence; Fistula
Study type: Observational

Summary: 
      Obstetric fistula, also called vaginal fistula, is a serious medical condition which affects
      women in low income countries. Despite the strengthening of research on fistula, there is
      little data on the follow-up after fistula repair.

      The objective of this study is to analyse the factors associated with the recurrence of
      fistula and the outcomes of pregnancy following fistula repair in Guinea. It will target
      women who got a closed fistula at discharge after repair in 2012/2015 at three fistula repair
      sites supported by the Fistula Care Project in Guinea (Kissidougou Prefectoral Hospital, Labé
      Regional Hospital and Jean Paul II Hospital of Conakry).

      The outcomes of interest are fistula recurrence and pregnancy. The predictors of interest
      will include patient characteristics, fistula characteristics, the context of repair and the
      context of reintegration.

      Participants giving an informed consent after a home visit by the Fistula Counsellors who
      managed women during surgery will be interview at enrolment and every six month from
      inclusion. The study duration is estimated at 48 months (January 2012 to March 2016)
      including the retrospective part.

      A sample size of 364 women will estimate the recurrence of fistula with a plus/minus 2%
      margin of error (width of confidence interval is 4%) and 95% confidence interval and is
      sufficient to estimate the rate of pregnancy with a two-sided 95% confidence interval and 10%
      precision.

      The cumulative incidence rate of fistula recurrence will be calculated using Kaplan-Meier
      methods and the risk factor analysis will be performed using adjusted cox regression.

      For the outcomes of pregnancy, Pearson's Chi Square (χ2) will be used to compare proportions
      of pregnancy outcomes between potential predictors and logistic regression models will be
      used and associations will be reported as risk ratios with 95% confidence intervals.

      Analysis will be done using STATA version 13 (STATA Corporation, College Station, TX, USA)
      with a level of significance set at P<0.05.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study population is composed of women who underwent repair for obstetric fistula in
        three fistula repair hospitals in Guinea from 1 January 2012 to 30 June 2015.
To Demonstrate the Relative Bioavailability of Atenolol Tablets
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Atenolol tablets.
    


Intervention name(s): Atenolol Tablets 100 mg (Cord Laboratories); Atenolol Tablets 100 mg (Stuart Pharmaceutical)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atenolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison Study of Feeding Prematures in the Side-lying Position on the Right and Left Side - a Pilot Study.
Condition: Bottle Feeding; Premature
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Methods and techniques to improve the quality and safety of oral feeding in preterm infants
      are still a significant challenge in modern neonatology. One of the areas that can help
      improve feeding is choosing the optimal feeding position for premature babies.
    

Detailed description: 
      PURPOSE: The aim of the study is to compare the advantages of side-lying positioning on the
      right (SLP-R) and left side (SLP-L) of infant's body, during bottle-feeding of preterm
      infants.

      METHOD: The study will include eight neonates (n=8) born ≤34 weeks of gestational age. Four
      bottle-feeding sessions will be tested in each of the newborns: two in the SLP-R and two in
      the SLP-L. The position for the first study will be randomly assign, then positioning will be
      change after each feeding session. In one day, only two consecutive feeding sessions will be
      tested which will be included to the study in order to minimize fatigability as a disrupting
      factor. The levels of saturation (SpO2) and heart rate (HR) will be measured as the
      parameters indicative of the newborn's physiological stability. The factors determining the
      qualitative aspect of feeding include the total time of declines of SpO2 ≤85%, level of the
      newborn's alertness according to the Neonatal Behavioral Assessment Scale (NBAS), and the
      occurrence of choking episodes. The proportion of milk consumed (volume of milk eaten
      relative to the expected volume) and the duration of the feeding and feeding session were
      also will be record. Maximum time of feeding session will be 40 minutes.

      Also the posseting during/after feeding and regurgitations will be record in each tested
      positions.
    

Intervention name(s): Experimental SLP-R; Experimental SLP-L
Intervention type(s): Other; Other
Intervention description(s): SLP-R will be given to the infant during bottle-feeding.; SLP-L will be given to the infant during bottle-feeding.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Premature Infant; Bottle Feeding; Side-lying Position; Oral Feeding