bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Massage With Peppermint Oil on Labor Pain
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Birth is a very special experience for a woman and her family. Labor pain is one of the
      strongest known and defined pains today. In the literature, it has been stated that labor
      pain is perceived as more severe than chronic pain such as low back pain, cancer pain,
      phantom pain and postherpetic neuralgia, and acute pain such as fracture or laceration.

      When birth pain is not controlled, the vicious cycle of stress, fear and pain can continue
      and affect the mother and fetus negatively.

      In this study, our aim is to determine the effect of applying peppermint oil diluted with
      pure natural olive oil to the abdomen and waist region by massage in labor pain, reducing the
      labor pain.
    

Detailed description: 
      The study is a Prospective Cross-sectional Case Control study. Pregnant women whose mother
      tongue is Turkish, who are term pregnant and who are in active labor, who are hospitalized in
      the delivery room of our hospital for delivery, that is, who have a gap of at least 70% 5-6
      cm in the examination and who have at least 4-5 severe contractions in 10 minutes, who have a
      single, vertex-presented fetus will be included in our work. Pregnant women with
      co-morbidities, chronic diseases, complications related to childbirth, anemic inactive labor,
      thyroid disease, skin lesions or infections, allergies, multiple pregnancies, use of any
      medication, and risky pregnancy will be excluded from the study.

      For this, 30 pregnant women who were applied peppermint oil and 30 control group pregnant
      women who were not applied will be included in the study. Following the signed consent form
      obtained from our patients, visual analog scoring (VAS) will be provided to the patient
      during the painful period, and then peppermint oil will be applied to the abdomen and lumbar
      region where he feels the most pain, with 1/10 diluted peppermint oil by hand massage or with
      the help of a compress moistened with warm water. After the application, visual pain scoring
      will be applied to pregnant women again.The study is terminated when sufficient data is
      obtained.

      The data will be entered into the computer in the SPSS program.
    

Intervention name(s): massage with peppermint oil
Intervention type(s): Other
Intervention description(s): Peppermint oil diluted with 1/10 pure olive oil will be applied to the pregnant to reduce labor pain.
Intervention MeSH terms: Peppermint oil
Intervention model: Single Group Assignment
Intervention model description: Two groups with mint oil control group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: labor pain; mint oil; Visuel anolgue Scoring
Synbiotics Interventions for Managing Cirrhosis and Its Complications
Condition: Cirrhosis, Liver; Metagonimiasis
MeSH terms: Trematode Infections; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Background Liver cirrhosis is commonly accompanied by intestinal dysbiosis and metabolic
      defects. Many clinical trials have shown microbiota-targeting strategies represent promising
      interventions for managing cirrhosis and its complications. However, the influences of the
      intestinal metagenomes and metabolic profiles of patients have not been fully elucidated.

      Methods administered lactulose, Clostridium butyricum, and Bifidobacterium longum infantis as
      a synbiotic and used shotgun metagenomics and non-targeted metabolomics to characterize the
      results.
    


Intervention name(s): Entecavir 0.5 mg; A 10-g packet of lactulose oral solution and three capsules of probiotics; A 10-g packet of glucose oral solution and three capsules of starch
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): Orally administered Entecavir 0.5 mg, once a day. For six months; A 10-g packet of lactulose oral solution and three capsules of probiotics (each containing > 4.2×106 CFU Clostridium butyricum and > 4.2×105 CFU Bifidobacterium longum infantis).
Participants orally administered the contents three times daily after meals. For six months.; A 10-g packet of glucose oral solution and three capsules of starch. Participants orally administered the contents three times daily after meals. For six months.
Intervention MeSH terms: Entecavir; Lactulose; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cirrhosis, Liver; Synbiotics
Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16,
      EU sourced Prolia, and US sourced Prolia in healthy male subjects.
    


Intervention name(s): Denosumab
Intervention type(s): Drug
Intervention description(s): 60 mg, single-dose
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
EValuation of the Antioxidant and Anti-inflammatory Capacity of Nutraceutical IMMU·SYSTEM Food Supplement (EVAANIS)
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      The aim of the study is to verify the effectiveness of Nutraceutical IMMU·SYSTEM Dietary
      supplement in reducing the levels of oxidative stress and inflammation in a sample of healthy
      adult subjects with high baseline levels of oxidative stress.
    


Intervention name(s): Immusystem; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Dietary supplement containing: Piceid, Glycine, Glutamine, Acetylcysteine, Zinc and Vitamin B6; Maltodextrin placebo capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Oxidative Stress; Glutathione; Immune system activity; Food supplement
Physical Therapy Interventions Following Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Injuries; Pain, Postoperative; Kinesiophobia
MeSH terms: Pain, Postoperative; Rotator Cuff Injuries; Kinesiophobia
Study type: Interventional

Summary: 
      In the post-arthroscopic rotator cuff repair (ARCR) management, physical therapy intervention
      is an important factor in bringing about a clinically positive prognosis. However, no
      conclusive therapeutic evidence has been found for various physical therapy interventions. In
      this study, the investigators would like to investigate the effects of physical therapy
      interventions on ARCR patients.
    


Intervention name(s): physical therapy intervention
Intervention type(s): Behavioral
Intervention description(s): physical therapy interventions include thermal therapy, electrical therapy, manual therapy, and therapeutic exercise.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pain and Readmission After Lap IPOM vs. Robotic Ventral Hernia Repair
Condition: Hernia, Ventral
MeSH terms: Hernia; Hernia, Ventral
Study type: Observational

Summary: 
      Comparison of results after rTARUP and lap IPOM in patients with small- and medium-sized
      ventral hernia. Retrospective cohort study of consecutive patients undergoing rTARUP or IPOM
      repair for small or medium-sized primary ventral and incisional hernias. The primary outcome
      was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter,
      secondary outcomes were 30-day complications, and length of stay. All patients underwent
      elective surgery and were followed for 30 days postoperatively.
    

Detailed description: 
      Single-center retrospective cohort study of consecutive patients undergoing rTARUP or IPOM
      repair for small or medium-sized primary ventral and incisional hernias. The primary outcome
      was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter,
      secondary outcomes were 30-day complications, and length of stay. All patients underwent
      elective surgery and were followed for 30 days postoperatively.
    

Intervention name(s): robotic repair
Intervention type(s): Procedure
Intervention description(s): robotic assisted retromuscular hernia repair
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study population is all patients referred from primary sector and eligible for laparoscopic
        primary ventral or incisional hernia repair
Diet/Activity of Mexican American and Anglo Children
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To perform a follow-up study of physical activity and dietary behaviors and their
      determinants in 10- to 11-year-old Anglo and Mexican-American children from low- and
      middle-socioeconomic status (SES) families who were studied initially when they were 4 to 7
      years old.
    

Detailed description: 
      BACKGROUND:

      It is well documented that the roots of cardiovascular diseases (CVD) are evident in
      childhood, and elevated levels of serum lipids, blood pressure and body fat are common in
      childhood. These risk factors are, in turn, related to childhood dietary and physical
      activity habits. To understand the early development of CVD, it is therefore important to
      study factors that influence diet and physical activity behaviors in children. Most studies
      concerned with the determinants of diet and physical activity in children are
      cross-sectional, limiting their utility for improving understanding of the development of
      these key health behaviors.

      The study allowed prospective analyses of the behaviors over a significant portion of the
      prepubertal age range. Knowledge of the determinants, stability, and relationships of
      childhood dietary and physical activity behaviors to physiologic risk variables could be
      useful for setting priorities and designing public health interventions for the next
      generations of youth.

      The major contribution of this San Diego SCAN study was in the longitudinal analysis of
      dietary and physical activity behaviors in children. The follow-up assessment of the 10-to
      11-year-old cohort and their mothers produced data that substantially improved understanding
      of the determinants and tracking of children's dietary and physical activity behaviors, as
      well as their relations to CVD risk factors.

      DESIGN NARRATIVE:

      Selection of subjects studied was based on social learning/cognitive theory, which states
      that behaviors are a function of personal and environmental factors. The specific aims of the
      study were as follows: 1) To study the determinants of physical activity and dietary intake
      of fat, sodium, and calories, and changes in these behaviors in children from ages 4 to
      10-11. 2) To determine the relationships between diet and physical activity practices and
      physiologic indicators of risk, such as blood pressure, adiposity, body mass, and serum
      lipoproteins at ages 4 to 10-11. 3) To describe the time trends and the degree of tracking of
      physical activity habits and nutritional intake of fat, sodium, and calories in children from
      ages 4 to 10-11. The study was renewed in 1999.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
Safety Study of Larazotide Acetate to Treat Celiac Disease.
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the safety, pharmacokinetics and efficacy of larazotide acetate in patients
      with controlled celiac disease on a gluten-free diet following a gluten challenge.
    

Detailed description: 
      CLIN1001-002 was a Phase 1b, randomized, double-blind, placebo controlled study to determine
      the safety, tolerance, pharmacokinetic and pharmacodynamic effects of single doses of
      larazotide acetate in subjects with celiac disease subjects. Study subjects were randomized
      (2:1) to receive single oral doses of larazotide acetate 12 mg or matching placebo once daily
      for 3 days. Subjects received a single-blinded gluten challenge (5 mg amygluten) on Day 2.
      Intestinal permeability was measured each day following dosing. Intestinal permeability was
      measured by administration of an oral sucrose, lactulose and mannitol solution followed by a
      6-hour urine collection. Serial blood samples were collected for pharmacokinetic
      determinations at baseline and 2 and 3 hours post dose; for zonulin determinations at
      baseline (prior to first dose) and 3 hours post dose; and for cytokine determination at
      baseline and 3 hours post dose (Days 2 and 3 only) and on Day 7. Sucrose, lactulose,
      mannitol, zonulin and larazotide acetate concentrations were determined by validated
      analytical methods.
    

Intervention name(s): larazotide acetate
Intervention type(s): Drug
Intervention description(s): larazotide acetate 4 mg capsules
Other intervention name(s): AT-1001; INN-202
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: larazotide acetate
Pharmacokinetics of BPV Following Bilateral US-guided TAP Block for C-section
Condition: Anesthesia; Adverse Effect; Cesarean Section; Transversus Abdominis Plane Block
Study type: Observational

Summary: 
      The transversus abdominis plane block (TAP block) is an effective method of postoperative
      pain management after cesarean section (C-section). Up to now, there are no data available
      about bupivacaine (BPV) plasma levels after TAP block in adults. In the current study, the
      investigators aimed to assess BPV pharmacokinetic parameters after ultrasound-guided TAP
      block using BPV in parturients undergoing C-section and to report its effects on corrected QT
      interval.
    

Detailed description: 
      The investigators led a prospective observational study in pregnant women undergoing elective
      C-section under spinal anesthesia (SA) using 10 mg of hyperbaric BPV. After surgery, they
      received bilateral ultrasound-guided TAP block with 50 mg of BPV in each side. Venous blood
      samples were collected immediately before and at 10, 30, 45, 60, 90, 120, 180, 240, 720 and
      1440 minutes after both TAP blocks. The investigators used high performance liquid
      chromatography (HPLC) to measure BPV total plasma concentrations. Mean BPV area under the
      curve (AUC) was calculated from 0 to 24 hours according to the linear trapezoidal rule. Mean
      peak of total BPV plasma concentration (Cmax) and time to reach the peak (Tmax) were
      recorded. Electrocardiographic (ECG) recordings were also repeated at 1, 2, 3 and 4 hours to
      investigate the effect of BPV on corrected QT (QTc) intervals. Data were computed using SPSS
      20®. Quantitative data were expressed as means ± SD. Qualitative data were expressed as
      percentages.
    

Intervention name(s): Bupivacaine
Intervention type(s): Drug
Intervention MeSH terms: Bupivacaine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        After obtaining approval by the institute ethics committee and having written informed
        consent signed on the day of surgery, 17 American Society of Anesthesiologists (ASA)
        physical status I-II pregnant women aged between 20 and 40 years scheduled for elective
        C-section with Pfannenstiel incision, under SA, were enrolled in this study.
      
Keywords: bupivacaine; local anaesthetics; cesarean section; transversus abdominis plane block; toxicity; ultrasound guidance; QTc interval
MyNewOptions: An Online Study of Reproductive Life Planning and Contraceptive Action Planning
Condition: Contraceptive Use; Unintended Pregnancy
Study type: Interventional

Summary: 
      The purpose of this web-based study is to determine whether reproductive life planning (RLP),
      with or without contraceptive action planning (RLP+), will result in reduced risk of
      unintended pregnancy when compared to an information-only control group.
    

Detailed description: 
      Most US families want 2 children, resulting in the average woman spending 3 decades of her
      life trying to avoid pregnancy. However, most women have at least one unintended pregnancy,
      resulting in 1.5 million abortions and 1.7 million unintended births annually. Women and
      couples try to avoid unintended pregnancy for a range of personal, social, and economic
      reasons, but also due to the increased physical and mental health effects for children that
      result from unintended pregnancy. Healthcare reform now requires that private health
      insurance companies cover all FDA-approved contraceptive methods with no copays or
      deductibles to the patient, creating a great opportunity for women with health insurance to
      get contraceptive methods they previously could not afford. In this study, women with health
      insurance will be randomly assigned to one of three groups: (1) Reproductive Life Planning
      (RLP)-women will complete a reproductive life plan that guides them to think about if and
      when they would want any future pregnancies, and to determine what contraceptive method(s)
      are best suited to them; (2) Reproductive Life Planning Plus (RLP+) which additionally
      includes "if-then planning," where women determine what they will do when they encounter
      difficult situations that make it difficult to use their contraceptive method perfectly; or
      (3) an information-only control group. The online format of the study allows for the
      potential of wide dissemination. The RLP and RLP+ interventions are expected to result in
      greater likelihood of contraceptive use, continuity of contraceptive use, and contraceptive
      adherence, and thus reduce overall risk of unintended pregnancy.
    

Intervention name(s): Reproductive Life Planning (RLP); Contraceptive Action Planning; Contraception information
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: reproductive life planning; action planning; contraceptive use; unintended pregnancy
Attitudes Towards Disability of Nursing and Physiotherapy Students
Condition: Disability Physical; Disabilities Multiple; Disability Hearing; Disability, Vision; Disability, Intellectual
MeSH terms: Intellectual Disability; Vision Disorders
Study type: Observational

Summary: 
      The general objective of this study is to know the attitude towards people with disability of
      Nursing and Physiotherapy students in the University of Cadiz. This is a descriptive,
      correlational, transversal and synchronous study.
    

Detailed description: 
      Attitudes determine our behaviour to some extent. Health professionals should have a global
      perspective of disability. They must provide treatment to people with disability and care for
      them, but also should accept them with no judgements or discrimination. The general objective
      of this study is to know the attitude towards people with disability of Nursing and
      Physiotherapy students in the University of Cadiz. Method: This is a descriptive,
      correlational, transversal and synchronous study. A total of 200 students participate in the
      study (91 from the Bachelor's Degree in Nursing and 109 from the Bachelor's Degree in
      Physiotherapy). The 'Attitudes towards people with disability Scale' was used.
    

Intervention name(s): 'Attitudes towards people with disability Scale'
Intervention type(s): Other
Intervention description(s): The scale 'Attitudes towards people with disability' was completed by the participants. This scale allows the analysis of the attitudes towards disability trough a score whose lower values indicate a more negative attitude and higher values indicate more positive attitudes.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Students enrolled in the Physiotherapy or Nursing Bachelor´s Degree of the University of
        Cadiz during the academic year of 2017/2018
      
Keywords: Physiotherapy students; Nursing students; Disability; Attitude
A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels
Condition: Ethanol Intoxication
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Double-Blind Trial to Assess the Interaction Between ADX-629 and Ethanol While Exploring
      the Safety, Tolerability, and Activity of ADX-629 in Subjects With Elevated Ethanol Levels
    


Intervention name(s): ADX-629; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 oral doses of ADX-629 600 milligrams; 3 oral doses of placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aldeyra; ADX-629
Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose
      combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive
      agent.
    

Detailed description: 
      IND Number: 79,599 and 101,943

      Other: Phase 1 Clinical Pharmacology drug interaction study in healthy female subjects
    

Intervention name(s): FDC of Daclatasvir, Asunaprevir and BMS-791325; FDC of Norethindrone and Ethinyl Estradiol; BMS-791325
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Loestrin®
Intervention MeSH terms: Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Estradiol; Asunaprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)