bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Controlled Trial of Oral Acetaminophen for Analgesic Control After Transvaginal Oocyte Retrieval
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Current standard of care is no pretreatment medications before the egg retrieval, and the
      investigators would like to evaluate if preoperative Tylenol improves procedure and post
      procedure pain control over the current practice (no pre-treatment). Specifically, this study
      will compare Tylenol with a placebo when given before retrieval procedures. The investigators
      believe that if Tylenol can offer better analgesic relief than no pretreatment medications,
      then it may reduce the amount of narcotics needed by patients during and after the procedure
      and contribute to better patient satisfaction. . This study will enroll 100 participants all
      from University of Alabama at Birmingham (UAB).
    

Detailed description: 
      The current standard of care for oocyte retrieval in IVF involves fentanyl, propofol, as well
      as oxycodone. However, there exists little data of alternatives to narcotic medications for
      analgesic purposes in oocyte retrieval procedures. A retrospective study published in 2013
      showed potential for NSAID's, specifically ketorolac, to significantly improve pain scores in
      women undergoing oocyte retrieval. It was also shown that the use of these medications did
      not significantly alter pregnancy rate, live birth rate, or miscarriage rate in these
      patients. Few other studies have delved into the question of anesthetics for oocyte
      retrievals except a prospective study in 2006. This study shows that no significant
      difference in pregnancy rates of implantation occurs with the use of acetaminophen and
      diclofenac vs. acetaminophen alone if given post-operatively. However, pain was not measured
      in this study for either group. Therefore, it is clear that there exists limited data on the
      subject of analgesics used in oocyte retrievals for in vitro fertilization and that more
      exploration into alternative medications is required to find the most effective and least
      harmful option.
    

Intervention name(s): Acetaminophen; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Acetaminophen total dose of 1000mg; subjects randomized to this group will be given placebo tablets
Other intervention name(s): Tylenol; paracetamol; sugar pill
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Analgesic; Pain Control; IVF; Tylenol; Acetaminophen; Egg Retrieval; iv vitro Fertilization
Effects of Diet on Pregnancy Outcome and Child Obesity
Condition: Pregnancy Related; Diet Modification; Obesity; Hypertension; Pre-Eclampsia; Blood Pressure; Breast Feeding; Birth Weight
MeSH terms: Eclampsia; Pre-Eclampsia; Obesity; Pediatric Obesity; Birth Weight
Study type: Interventional

Summary: 
      The purpose of the study is to compare 3 different diets in pregnancy, equal in calories, and
      fats, different in refined grains compared to whole grains as a source of carbohydrates, and
      in calories from carbohydrate, compared to protein as a source of calories.The hypothesis is
      that there will be differences in the specified outcomes because the proportions of
      macronutrients are significant. The primary objective is to detect differences in weight
      gain.
    

Detailed description: 
      There will be randomized sequential assignment of pregnant women at the initial clinic visit
      to Diet A, a high proportion of calories from refined grains as a carbohydrate source, and
      Diet B, a high proportion of calories from whole grains. Random number assignment is
      impractical for counseling purposes and blinding not possible. Therefore, randomization by
      diet assignment by day of initial visit via random number was chosen. If the random number is
      odd Diet A would be selected, if the random number is even Diet B will be selected for that
      day.
    

Intervention name(s): Refined Grains; Whole Grains
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): In week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance.; In week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase 1a, single-center, double-blind, randomized, placebo-controlled study of the
      safety, tolerability, PK, and PD of single ascending doses of RB006 administered as an SC
      injection, with and without IV RB007 (an active control agent for RB006), in healthy young
      volunteers. The study originally planned to enroll 4 cohorts of 8 subjects each (N=32);
      however, upon review cohort (Cohort 1-A) was necessary in order to fully define the PK
      profile of SC RB006. Therefore, 36 subjects were enrolled in this study.

      Each cohort was balanced by sex with no more than 2/3 of one sex enrolled in any particular
      cohort (i.e., 5 of 8 subjects in each cohort). No subject participated in >1 dose group, and
      progression to the next higher dose only occurred if the prior dose level was well tolerated,
      as assessed by a Safety Review Committee (SRC)
    


Intervention name(s): Subcutaneous RB006 0.5 mg/kg; Subcutaneous RB006 1.0 mg/kg; Subcutaneous RB006 3.0 mg/kg; Subcutaneous RB006 2.0 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous RB006 0.5 mg/kg; Subcutaneous RB006 1.0 mg/kg; Subcutaneous RB006 3.0 mg/kg; Arm 1: 4 subjects received an IV bolus injection of 1 mg/kg RB007 at 72 hours post-RB006 administration
Arm 2: 4 subjects received an IV bolus injection of 1 mg/kg RB007 at 24, 72, and 120 hours post-RB006 administration.; Placebo
Other intervention name(s): SC RB006; SC RB006; SC RB006; SC RB006; SC Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Blue Light Phototherapy
Condition: Grover's Disease; Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      This study will use Blue-light Photo-therapy to treat patients with psoriasis vulgaris and
      Grover's Disease.
    


Intervention name(s): Blue light phototherapy
Intervention type(s): Device
Intervention description(s): Phototherapy- Wavelength: 417±15 nm
Other intervention name(s): DusaPharma Blu-U model 4170
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Hookah Smoking on Blood Flow to the Heart, Muscle and Skin
Condition: Hookah Smoking
Study type: Interventional

Summary: 
      This is a pilot study on acute effects of Hookah smoking on the sympathetic neural control of
      the human cardiovascular system. Hookah smoking is known to transiently increase blood
      pressure and heart rate while decreasing heart rate variability suggesting - but not proving
      - sympathetic mediation. Here the investigators will directly measure the acute effects of
      Hookah smoking on sympathetic nerve activity with microneurography (intraneural
      microelectrodes) and quantify associated regional changes in vasomotor tone.
    


Intervention name(s): Hookah smoking
Intervention type(s): Other
Intervention description(s): Subjects will smoke waterpipe in a controlled research environment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hookah; waterpipe; smoking; sympathetic
Acceptability, Gastro Intestinal Tolerance Compliance of a Paediatric Tube-feed Formula Derived From Food for Children
Condition: Child Nutrition Disorders
MeSH terms: Nutrition Disorders; Child Nutrition Disorders
Study type: Interventional

Summary: 
      This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over
      a seven-day period, of pediatric formula for the dietary management of participants with
      short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished
      patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding
      intolerances, developmental disabilities, disease related malnutrition The acceptability data
      from 15 participants will be collected in order to submit an application to the Advisory
      Committee on Borderline Substances (ACBS).
    

Detailed description: 
      Patients well established and stable on a standard enteral tube feed will be changed to a
      paediatric formula for a period of seven days. This group will act as their own controls.
      Each child will receive for a period of seven days the paediatric formula, a nutritionally
      complete standard enteral tube feed.

      The dietitian will determine the feeding regimen on an individual basis and the enteral
      formula will be provided via a feeding tube. A baseline questionnaire will be completed by
      the dietitian to ensure eligibility of study, current stool patterns or symptoms, current
      oral intake and weight at the start of the study.

      The parents will complete a week intake chart to monitor how much feed has been consumed each
      day and a tolerance diary to review gastrointestinal symptoms at the start and end of the
      study.
    

Intervention name(s): Pediatric Formula
Intervention type(s): Other
Intervention description(s): One week intake diary, one week tolerance diary, product intake
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Acupuncture as Treatment of Post-herpetic Neuralgia: A RCT A Double-blinded Randomized Clinical Trial.
Condition: Post Herpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional

Summary: 
      The aim of this study is to perform the first RCT investigating the possible effect of
      superficial dry-needling (SDN) - a special kind of acupuncture used for PHN. The participants
      will be divided into two groups. Group A, the intervention group will receive SDN in the area
      of pain. Group B, the control group will receive a sham procedure.
    

Detailed description: 
      The aim of this study is to investigate the possible effect of SDN on PHN. The study
      population consists of patients with chronic pain after herpes zoster.

      The study is a controlled double-blinded randomized study. The participants will be divided
      into two groups, group A, the intervention group, will receive SDN in the area of pain. Group
      B, the control group will receive a sham procedure. The procedure will take place at the
      out-patient clinic at Odense University Hospital. The plan is to include 40 patients (20 in
      each group).
    

Intervention name(s): Superficial dry needling / Acupunture
Intervention type(s): Procedure
Intervention description(s): Se arm-description.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants will be divided into two groups, group A, the intervention group, will receive SDN in the area of pain. Group B, the control group will receive a sham procedure.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: post-herpetic neuralgia; pain; post herpetic neuralgia; shingles; autologous fat grafting; autologous fat transplant
Evaluation of Lofexidine for Treatment of Opiate Withdrawal - 10
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety of lofexidine in the treatment of
      opiate-dependent individuals.
    


Intervention name(s): Lofexidine
Intervention type(s): Drug
Intervention MeSH terms: Lofexidine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid dependence
Clinical Evaluation of Bass and Treble Controls for CI Subjects
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      The clinical study is designed to evaluate the safety and effectiveness of recipient
      controlled Bass and Treble.
    

Detailed description: 
      Bass and Treble controls provide the CI recipient with access to the adjustment of low and
      high frequency sound balance, known as Bass and Treble respectively. The clinical study is
      designed to evaluate the safety and effectiveness of recipient controlled Bass and Treble.

      Subjects will have access to the Bass and Treble controls during a 4 week take-home period,
      and will complete questionnaires and diaries to provide descriptive data on the Bass and
      Treble adjustments made during take home use, and the success of these adjustments.

      Pre and post intervention speech test results will be used to evaluate the effect of access
      to Bass and Treble controls on speech perception. The post intervention questionnaire will
      provide information on the overall ratings of the Bass and Treble controls.
    

Intervention name(s): Bass and Treble
Intervention type(s): Device
Intervention description(s): Bass and Treble controls are clinician enabled and provide the recipient with access to the adjustment of low and high frequency sound balance, known as Bass and Treble respectively
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers
Condition: Infections
MeSH terms: Endotoxemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Corticosteroids are substances produced by the adrenal gland to help the body fight against
      infection or injury. Hydrocortisone is a man-made form of this substance. Endotoxin is a
      man-made substance, which causes the body to "mimic" sickness(fever,chills,and achiness)for a
      few hours. This study is designed to give hydrocortisone before and after Endotoxin to
      determine if this medication can prevent or relieve any of the symptoms caused by the
      Endotoxin.
    

Detailed description: 
      The body's immune response to injury otr infection is very complex. Immune cell activity, the
      release of specific mediators (such as proteins), genetics (Deoxyribonucleic acid or DNA)
      and/or the body's "instructions" for making proteins (Ribonucleic Acid or RNA) may effect the
      body's clinical response to a stress such as an infection.Hydrocortisone is a substance
      produced by the body (in the adrenal gland)in response to stress such as infection or injury.
      Endotoxin is a man- made substance, which causes the body to "mimic" sickness (fever, chills,
      and achiness) for a few hours. This study is designed to give hydrocortisone before and/or
      after endotoxin to determine if this medication can prevent or relieve any of the symptoms
      caused by endotoxin.In addition, this study may determine whether any of the
      above(proteins,DNA,RNA,etc.) correlate with or affect the body's response to hydrocortisone
      and/or endotoxin. This will enable the investigator to better understand whether treatment
      with this substance can alter the body's immune response.
    

Intervention name(s): Endotoxin, Lipopolysaccharide, LPS; Endotoxin, Lipopolysaccharide, LPS /Epinephrine; Placebo; Hydrocortisone
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, bolus IV administration (~5 minutes); Clinical Center Reference Endotoxin, lot 2, sterile saline, 1 ng/kg, continuous IV administration (Hydrocortisone 3mcg/kg/min); Saline vehicle (placebo); Hydrocortisone
Other intervention name(s): Sodium Chloride Solution; Solu-Cortef
Intervention MeSH terms: Hydrocortisone; Hydrocortisone hemisuccinate; Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Immune System
Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC)
Condition: Cannabis Use Disorder
MeSH terms: Hyperemesis Gravidarum; Marijuana Abuse
Study type: Interventional
Phase: Phase 4

Summary: 
      Cannabis Hyperemesis Syndrome (CHS) has become a well-documented syndrome since 2004 and is
      expected to increase in prevalence with continuing liberalization of marijuana and
      recognition of the disease. Regardless of whether the association with heavy cannabis use is
      recognized, there is well-documented resistance to traditional anti-emetic treatment. Given
      promising reports of the use of intravenous haloperidol, a randomized controlled trial
      comparing it to the commonly administered anti-emetic ondansetron will contribute to the
      management of CHS
    

Detailed description: 
      This is a double-blinded, randomized, cross-over clinical trial that will enroll
      approximately 80 subjects from at least four different research sites. Patients who have been
      diagnosed with CHS and enrolled in our study will act as their own controls upon their return
      to the ED for a subsequent bout of CHS for up to 3 visits per subject. Each patient will be
      allocated in a 1:1:1 fashion into one of three treatment groups: high- or low-dose
      haloperidol, or ondansetron, with a minimum 7-day washout period between treatments. As CHS
      tends to be a recurrent syndrome (presumably given the continued use of cannabis despite
      recommendations to taper and abstain), it is expected that most subjects will return at least
      once again, and a substantial subset of the study population will complete all three
      treatment visits during the trial.
    

Intervention name(s): Ondansetron 8mg; Haloperidol 0.05mg/kg; Haloperidol 0.1mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ondansetron 8 MG prepared in a 100 mL normal saline min-bag; Haloperidol 0.05 mg/kg prepared in a 100 mL normal saline min-bag; Haloperidol 0.1 mg/kg prepared in a 100 mL normal saline min-bag
Other intervention name(s): Zofran; Haldol; Haldol
Intervention MeSH terms: Haloperidol; Ondansetron; Haloperidol decanoate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a double-blinded, randomized, cross-over clinical trial that will allocate subjects in a 1:1:1 fashion into one of three treatment groups: high- or low-dose haloperidol, or ondansetron, with a minimum 7-day washout period between treatments.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cannabis; haloperidol; ondansetron; hyperemesis; cyclic vomiting syndrome
Prediction of Childhood Epilepsy Outcome in Bangladesh
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      Randomised controlled trial of the use of phenobarbitone and carbamazepine in childhood
      epilepsy in Bangladesh with particular reference to behavioural side effects.
    


Intervention name(s): phenobarbitone; carbamazepine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carbamazepine; Phenobarbital
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: childhood epilepsy; Active childhood epilepsy
A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Praliciguat in Healthy Male Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to characterize the pharmacokinetics (PK) of praliciguat and total
      radioactivity and to assess the elimination of total radioactivity from a single oral dose of
      [14C]-praliciguat.
    


Intervention name(s): [14C]-praliciguat
Intervention type(s): Drug
Intervention description(s): 10 mg praliciguat containing approximately 500 μCi of [14C]-praliciguat
Other intervention name(s): [14C]-IW-1973
Intervention MeSH terms: Praliciguat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of
      cariprazine in the treatment of outpatients with bipolar depression.
    


Intervention name(s): cariprazine; cariprazine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug: cariprazine (0.25 - 0.75 mg/day); Drug: cariprazine (1.5 - 3.0 mg/day); placebo capsules, oral administration, once daily dosing
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: bipolar; depression
Lived Experiences of Adolescents in the Treatment Process of Cancer and the Impact on Occupations
Condition: Pediatric Cancer
Study type: Observational

Summary: 
      The purpose of this phenomenological study is to discover and illuminate the experiences of
      adolescents in the treatment process of cancer and the meanings they attach to these
      experiences, while maintaining their daily routines. The focus area of interest lies in the
      impact side-effects (psychological and physical) which these treatments may have on an
      individual's ability to participate with peers, maintain social activities, and be involved
      in daily occupation(s).
    

Detailed description: 
      This study will explore the following research questions: 1. How do adolescent patients in
      the treatment process of cancer perceive and describe their experience of engaging in
      occupational routines? 2. What effect does the treatment process of cancer have on an
      adolescent's ability to participate in life situations such as creating and maintaining
      relationships with family, friends, peers, students, or people with similar backgrounds?

      By doing this study, researchers hope to gain information so that occupational therapists can
      increase the profession's present body of knowledge and better understand these individuals
      at a transitional period in their lives.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents being treating for cancer and the impact of their lived experience on
        engagement in occupations and social participation.
      
Keywords: Lived Experiences; Adolescents; Cancer Treatment; Occupations