bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Reflexology on Postpartum Pain, Fatigue, Sleep Quality and Lactation
Condition: Breast Feeding; Fatigue; Sleep; Pain, Postoperative
MeSH terms: Fatigue; Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this research is to determine the effect of foot reflexology applied to
      primiparous women who had cesarean section in the postpartum period on pain, fatigue, sleep
      quality and lactation. This research is a randomized controlled trial. The study was
      conducted in Şanlıurfa, which has the highest fertility rate in Turkey.
    

Detailed description: 
      The aim of this research is to determine the effect of foot reflexology applied to
      primiparous women who had cesarean section in the postpartum period on pain, fatigue, sleep
      quality and lactation. This research is a randomized controlled trial. The study was
      conducted in Şanlıurfa, which has the highest fertility rate in Turkey. The sample of the
      research consisted of 80 primiparous women (reflexology group: 40 and control group: 40). The
      data were collected between 01 January 2020 - 31 January 2021. "Introductory Information
      Form", "Visual Analogue Scale" for Pain, "Visual Analog Scale for Fatigue", "Pittsburg Sleep
      Quality Index" and "Bristol Breastfeeding Assessment Tool" were used as data collection
      tools. Foot reflexology was applied to the experimental group for 40 minutes (left foot 20
      minutes and right foot 20 minutes) once a week for postpartum 8 weeks. The control group was
      only watched. In the intergroup comparison of the experimental and control groups, chi-square
      for categorical variables and independent groups t-test for numerical variables were used.
      Two-way repeated measures ANOVA test was performed in terms of time and group interaction in
      repeated measurements
    

Intervention name(s): foot reflexology
Intervention type(s): Other
Intervention description(s): Foot reflexology was applied to the experimental group for 40 minutes once a week for postpartum 8 weeks. The control group was only watched.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: fatigue; lactation; pain; postpartum; sleep quality; reflexology
CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients
Condition: Hemodialysis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled study to assess the
      potential of physical withdrawal from CR845 upon treatment discontinuation after 3 weeks of
      IV administration at a dose of 0.5 mcg/kg in hemodialysis patients. The purpose of this study
      is to determine whether hemodialysis patients who take CR845 develop physical dependence and
      experience withdrawal symptoms upon cessation, as exemplified by symptoms consistent with
      opioid withdrawal. The study will consist of a Screening Phase, a 3-week Open-label Phase, a
      2-week randomized, placebo-controlled, Double-blind Phase and a Follow-up Visit.
    


Intervention name(s): CR845 0.5 mcg/kg; Placebo
Intervention type(s): Drug; Other
Intervention description(s): IV CR845 0.5 mcg/kg as a bolus injection; IV Placebo as a bolus injection
Other intervention name(s): Difelikefalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Difelikefalin; CR845; Physical Withdrawal; Hemodialysis; Dialysis; CKD; ESRD (end stage renal disease); Chronic Kidney Disease; Kidney failure, chronic; Kidney dysfunction
Benefits of the HiResolutionTM Bionic Ear System in Adults With Low-Frequency Hearing
Condition: Severe-to-profound Hearing Loss
MeSH terms: Hearing Loss
Study type: Observational

Summary: 
      The goal of this investigation is to generate the needed PMCF data for the HiFocus Mid-Scala
      electrode. As a point of interest the investigators would like to evaluate the benefit to
      patients with low-frequency residual hearing implanted with the HiFocus Mid-Scala Electrode.
      The HiFocus Mid-Scala electrode array is designed to allow surgeons the flexibility to use a
      variety of contemporary surgical techniques that have been shown to enable easy insertion and
      to minimize cochlear trauma (see, e.g., Adunka and Buchman, 2007; Friedland and
      Runge-Samuelson, 2009; Roland et al., 2007). Temporal bone experiments have shown the HiFocus
      Mid-Scala electrode array to be straightforward to insert while causing minimal trauma to
      cochlear structures during and after surgery (Lenarz et al., 2010). In addition , the HiFocus
      Mid-Scala has already shown to be a safe electrode and promising post op clinical results in
      the premarketing study that is now in the final stage.
    


Intervention name(s): Observational study
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        individuals with severe-to-profound hearing loss
Fluid Balance During Exercise in the Heat With Water, Flavored Placebo, or a Carbohydrate-electrolyte Beverage Intake (The APEX Study)
Condition: Dehydration
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      The purpose of the APEX study is to determine whether carbohydrate-electrolyte beverage
      intake promotes fluid balance during exercise in the heat compared with water or placebo
      intake.
    

Detailed description: 
      Exercise in the heat has large effects on cardiovascular strain, the ability to regulate core
      body temperature, and performance because of an increase in the reliance on body fluid
      distribution to the skin to maintain adequate sweat rates and heat dissipation.
      Carbohydrate-electrolyte beverage intake during exercise in the heat may improve fluid
      balance and subsequent physical performance.

      The participants will be assigned each arm in a randomized, counterbalanced, cross-over
      fashion separated by at least 2 weeks. Participants will be placed in a heated environment
      for the duration of the exercise intervention.
    

Intervention name(s): Exercise Intervention
Intervention type(s): Other
Intervention description(s): Exercise intervention trials will consist of a steady-state bout of exercise at ~70% VO2peak and a timed performance test on a cycle ergometer in a heated environment.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: dehydration; fluid balance; exercise; heat; body weight; performance
Surveillance Study of Acute Gastroenteritis in Hospitalized Children
Condition: Acute Gastroenteritis; Diarrhea; Dehydration
MeSH terms: Gastroenteritis; Dehydration; Diarrhea
Study type: Observational [Patient Registry]

Summary: 
      Acute gastroenteritis is a common cause of hospital admission and health office visits and
      have a huge burden on the economy of developing countries. The investigators proposed this
      observational prospective study during summer period in a community and tertiary care
      hospital in a rural area of Lebanon to investigate the etiologies and age distribution of
      admitted cases to general pediatric floor from the age of 1 month up to the age of 14 years.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        male and female patient from 1 month to 13 YO admitted to pediatric floor with acute
        gastroenteritis
      
Keywords: diarrhea; vomiting; fever; abdominal pain; oliguria
Tourniquets Increase Proximal Pressure
Condition: Blood Pressure
Study type: Interventional

Summary: 
      There is an urgent clinical need to improve survival and neurologic outcomes after cardiac
      arrest. When a patient goes into cardiac arrest, cardiopulmonary resuscitation (CPR) with
      chest compressions is the current standard of care treatment to mechanically circulate blood
      through the patient's body. The immediate and long-term success of CPR is critically
      dependent on the maintenance of adequate coronary and cerebral perfusion. The investigators
      propose that CPR outcomes can be improved by capitalizing on the innate mechanism of
      vasoconstriction and preferentially routing the limited oxygenated blood to the heart and
      brain. The proposed solution is occlusion of extremity vasculature will increase coronary and
      cerebral perfusion and improve patient outcomes after cardiac arrest. Prior research has
      investigated the efficacy of manipulating peripheral vascular resistance with tourniquets in
      animal studies with improved cardiac and cerebral perfusion and survival. To prove this is an
      adequate solution in humans, the investigators plan to use tourniquets on the legs to occlude
      the peripheral vasculature in healthy humans and measure more proximal blood pressure before
      and after tourniquet deployment. Proof of concept of this solution will make way for
      development of novel devices for use during cardiac arrest and CPR to improve heart and brain
      perfusion and ultimately improve cardiac arrest outcomes.

      The investigators will recruit 30 healthy human participants and measure their blood pressure
      in their arm. They will then place two commercially-available, FDA-approved tourniquets
      around each thigh to stop blood flow to the legs. The investigators will measure the blood
      pressure in the arms again. They will then release the tourniquets after blood pressure
      measurement. This will be repeated three times with breaks between each repetition.
    


Intervention name(s): combat application tourniquets (CAT)
Intervention type(s): Device
Intervention description(s): CAT tourniquets have been indicated for use in emergency situations revolving around a wounded limb, such as hemorrhage control.22-23 CAT tourniquets are the official tourniquet of the US Army since in 2005.
We will deploy well-studied and FDA approved combat application tourniquets (CAT) on both thighs of volunteer healthy adult subjects while measuring blood pressure in the upper extremities.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
IPF Italian Observational Study (FIBRONET) in Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The purpose of the present study is to evaluate the characteristics, management and clinical
      course of patients with IPF as treated under real-world in Italian Pulmonary Centres, in
      terms of symptoms, lung function and exercise tolerance during 12 months of observation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        IPF pts
A Study of the Prevalence of Headache in Epileptic Patients
Condition: Epilepsy
MeSH terms: Epilepsy; Headache
Study type: Observational

Summary: 
      The purpose of this study is to investigate the prevalence, characteristics and
      classification of headaches in epileptic patients.
    

Detailed description: 
      Headache is often ignored as a symptom of epileptic seizures. The purpose of this survey is
      to investigate the prevalence, characteristics and classification of seizure-associated
      headaches and non-seizure-associated headaches in epileptic patients in Korea, according the
      criteria of the International Headache Society 2004. In this survey, 577 consecutive patients
      with a recent diagnosis of epilepsy are interviewed by questionnaire about headaches
      associated with epileptic seizures. It involves questions about headache in general,
      localization, severity, duration and frequency, as well as headache associated with seizures,
      and about patient's family history. This Observational study does not involve the
      administration of any drugs.
    

Intervention name(s): A structured questionnaire for seizure-related headache
Intervention type(s): Other
Intervention description(s): A structured questionnaire for seizure-related headache
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with a recent diagnosis epilepsy; able to describe their symptoms by themselves;
        have had at least 2 episodes of seizures during the previous year; have had at least 1
        headache during the previous year.
      
Keywords: Epilepsy; Headache; Seizure
A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety of treating men with oligometastatic prostate cancer with the following
      therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant
      androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control
      with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to
      oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation.
      Androgen blockade will be the same throughout the course of treatment.
    

Detailed description: 
      Adjuvant treatment (month 1 through ~6): All patients will be treated with up to 6 months of
      androgen deprivation, plus up to 6 cycles of docetaxel chemotherapy. Following docetaxel
      therapy, patients with a Prostate-specific antigen response of at least a 50% decrease from
      baseline, will proceed to maximum consolidative therapy.

      Radiation (month 7 though ~11): After completion of adjuvant chemotherapy, the men will be
      treated with definitive local therapy with adjuvant radiation therapy (RT). After definitive
      local therapy, patients will be treated with consolidative stereotactic body radiation
      therapy (SBRT) to the metastatic sites (if present).

      Follow up: Patients will continue on androgen deprivation for a total of 2 years. They will
      be followed clinically and monitored with serum testosterone and Prostate-specific antigen
      until 2-years after completion of ADT (Androgen deprivation therapy) treatment. Androgen
      blockade will be the same throughout the course of treatment.
    

Intervention name(s): Leuprolide Acetate; Docetaxel; Bicalutamide; Radiation; Abiraterone Acetate
Intervention type(s): Drug; Drug; Drug; Radiation; Drug
Intervention description(s): 22.5mg by intramuscular (IM) injection every 3 months; 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.; bicalutamide (Casodex) 50mg by mouth daily; Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.; Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.
Other intervention name(s): Lupron Deport; Texotere; Casodex; Zytiga
Intervention MeSH terms: Docetaxel; Leuprolide; Abiraterone Acetate; Bicalutamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostatectomy; androgen deprivation; chemotherapy; radiation
A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      This is a study investigating treatment of plantar fasciitis (heel pain). Physicians commonly
      prescribe specialized orthoses (shoe inserts) to treat heel pain. This study will evaluate
      the reduction in heel pain associated with three types of orthoses. It is hypothesized that
      custom made orthoses will significantly decrease pain and improve foot function in comparison
      to prefabricated insoles and sham insoles.
    


Intervention name(s): orthoses
Intervention type(s): Device
Intervention description(s): orthoses are provided for use in standardized shoes that all subjects receive
Other intervention name(s): shoe insert
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heel pain
Efficacy Of Platelet Rich Plasma In The Treatment Of Hemiplegıc Shoulder Pain
Condition: Shoulder Pain; Shoulder Impingement; Hemiplegia, Infantile; Shoulder Subluxation; Spasticity, Muscle
MeSH terms: Muscle Spasticity; Shoulder Pain; Shoulder Impingement Syndrome; Hemiplegia
Study type: Interventional

Summary: 
      In this study assessing whether platelet rich plasma injections(PRP) are effective in the
      management hemiplegic shoulder pain, 55 patients with hemiplegic shoulder pain was recruited
      to this randomized controlled study. Patients were randomized into two groups, first getting
      PRP injections, and other group taking sham injections.
    


Intervention name(s): PRP; Exercise
Intervention type(s): Other; Other
Intervention description(s): A venous blood sample of 8.5 ml were obtained from patients. For the study group, the blood samples were mixed with 1.5 ml ACD-A or sodium citrate to achieve anticoagulation. Resulting material was then centrifugated for 5 minutes with RCF 1200 G speed to clump erythrocytes, and then centrifugated for 10 minutes in same speed to obtain thrombocyte concentrate. 2 ml's of the platelet rich plasma was injected to the shoulder of the subjects. For the sham injection group, same amount of blood was taken and they were given a of waiting time of same duration with the study group, with the resulting preparate being 2 ml's of 0,9% saline instead. PRP solutions were prepared with kits of Easy PRP(Neotec Biotechnology, Istanbul, Turkey).
Injections were done every two weeks, for a total of 3 times. 21 G injection needles with injection technique of posterior approach were used(18, 19). To provide blindness, all injections were done using injectors coated with non transparent tape.; All of the patients were also informed about proper positioning and the standard care for the affected extremity. Their process of neurological rehabilitation was not changed, which was 5 days of the week, one session of 45 minutes a day. They were also given a program of standardized ROM exercises, which included passive and active motions.
Other intervention name(s): Platelet rich plasma injections; Rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Shoulder Pain; Hemiplegia; Shoulder Subluxation; Spasticity; Stroke
Evaluation of the Child and Family Traumatic Stress Intervention
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of the Child and Family Traumatic
      Stress Intervention (CFTSI) in preventing the development of Posttraumatic Stress Disorder
      (PTSD) when implemented within 30 days of a potentially traumatic event.
    


Intervention name(s): Child and Family Traumatic Stress Interv (CFTSI); Psychoeducational Comparison
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 4 sessions involving both the target child and a parent/caregiver; 4 individually focused sessions including psychoeducation and relaxation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: School age children and adolescents exposed to a potentially traumatic event
Keyhole Limpet Hemocyanin in Chronic Hepatitis C
Condition: Chronic Hepatitis C; Liver Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      In this study the investigators examine the safety and efficacy of Keyhole-limpet-hemocyanin
      in patients with chronic hepatitis c infection and liver cirrhosis. The investigators
      hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in
      patients infected with hepatitis c.
    


Intervention name(s): keyhole-limpet hemocyanin
Intervention type(s): Drug
Intervention description(s): Subcutaneous administration keyhole-limpet hemocyanin
Intervention MeSH terms: Keyhole-limpet hemocyanin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of Acupuncture for Dental Pain: Testing a Model
Condition: Tooth, Impacted
MeSH terms: Tooth, Impacted
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is testing the safety and effectiveness of acupuncture in controlling pain related
      to the removal of partially impacted mandibular third molars. Acupuncture is the Chinese art
      of healing by inserting needles into the skin.

      Participants ages 18 - 40 are given an initial x-ray to determine if one lower molar is
      partially bony impacted. Eligible participants will then undergo standard oral surgery to
      remove the impacted molar. A local anesthetic will be used prior to surgery. Directly after
      surgery the participant will be assigned to one of three groups. Participants will not be
      able to select which group they are assigned. Participants will receive either real or sham
      (fake) acupuncture as a treatment for post-extraction pain. After the initial acupuncture
      treatment, participants are required to remain for six hours at the dental site to be
      monitored. If a participants discomfort is measured as moderate or higher then a second
      acupuncture treatment will be administered. All participants will be administered
      questionnaires during the day of surgery. Participants will also be required to complete two
      diaries during the seven days following surgery. On the seventh day, participants return to
      have stitches removed and hand in completed diaries.
    


Intervention name(s): Acupuncture
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Treatment