bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the
      Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of
      Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.
    


Intervention name(s): Fimasartan/Atorvastatin Combination Tablet; Fimasartan; Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rekovelle PK Trial in Chinese Women
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1

Summary: 
      FE 999049 is a gonadotropin preparation containing recombinant human follicle stimulating
      hormone (rhFSH) under development by Ferring Pharmaceuticals. It is intended for controlled
      ovarian stimulation for the development of multiple follicles in women undergoing assisted
      reproductive technologies (ART) such as in vitro fertilisation (IVF) or intracytoplasmic
      sperm injection (ICSI) cycle. In previous trials the exposure to and dose proportionality of
      FE 999049 in a clinically relevant dose range in Caucasian and Japanese healthy women have
      been shown to be very similar. This is a trial in healthy Chinese women investigating the
      pharmacokinetics, safety, and tolerability of a single subcutaneous dose of FE 999049.
    


Intervention name(s): Follitropin Delta
Intervention type(s): Drug
Intervention description(s): Solution for Injection, subcutaneous administration
Other intervention name(s): REKOVELLE; FE 999049
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: In vitro fertilisation; Controlled ovarian stimulation
Transversus Abdominis Plane Block and Inguinal Hernia Repair
Condition: Inguinal Hernia; Abdominal Wall Muscles; Regional Anesthesia; Postoperative Pain
MeSH terms: Pain, Postoperative; Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      This prospective, randomized, double blinded, placebo-controlled study is designed to
      evaluate the postoperative analgesic efficacy of the ultrasound-guided transversus abdominis
      plane block with ropivacaine 0,75 %, in patients undergoing unilateral inguinal hernia repair
      with a mesh under general anaesthesia, and how the efficiency of early postoperative
      analgesia achieved correlates with the risk of developing a chronic pain state, a not
      uncommon condition after this type of surgery.
    


Intervention name(s): Transversus abdominis plane block
Intervention type(s): Procedure
Intervention description(s): ultrasound guided transversus abdominis plane block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transversus abdominis plane block; inguinal hernia repair; acute postoperative pain; neuropathic pain
Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine at 5 years of age the persistence of immunity to
      hepatitis B that was conferred by infant vaccination with Infanrix hexa™.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    


Intervention name(s): Engerix™-B Kinder
Intervention type(s): Biological
Intervention description(s): Intramuscular injection, 1 dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Treatment of Chronic Stroke With AMES + EMG Biofeedback
Condition: Stroke; Plegia; Paresis; Cerebrovascular Accident
MeSH terms: Stroke; Paresis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if individuals who had a stroke more than one year
      before entering the study and who remain unable to open their affected hand are better able
      to sense and move their affected arm after 10-15 weeks of treatment with a new robotic
      therapy device (the AMES device) and EMG biofeedback.
    

Detailed description: 
      Over the last 20 years, the discovery of cortical plasticity in the adult human brain has led
      to the development of new therapies to rehabilitate stroke survivors whose recovery of motor
      function has stalled with conventional therapeutic methodology. However, the efficacy of
      these new therapies appears to be limited to relatively high-functioning chronic stroke
      patients. A therapeutic approach that may be efficacious in restoring functional movement to
      low-functioning chronic stroke patients is "AMES," which stands for Assisted Movement with
      Enhanced Sensation. Despite the efficacy of AMES in restoring movement to low-functioning
      hemiparetic stroke patients, those with plegia at a joint tend not to recover movement in the
      plegic direction with AMES treatment or with other rehabilitation therapies. The objective of
      this study is to determine if AMES treatment in combination with biofeedback can be helpful
      in restoring functional movement to plegic stroke patients.
    

Intervention name(s): AMES Therapy (assisted movement and enhanced sensation)
Intervention type(s): Device
Intervention description(s): Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device. One group of subjects will receive AMES therapy only with joint torque biofeedback (without EMG feedback), and the other group will receive AMES therapy with EMG biofeedback. While all test subjects should attempt to open the hand when the grasp mechanism is opening and close the hand when the mechanism is closing, the biofeedback information provided to aid a subject will differ for the 2 subject groups.
Other intervention name(s): Robotic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: AMES device; Cerebrovascular Accident; Chronic Stroke; Rehabilitation; Upper Extremity; Biofeedback
Long Term Efficiency of the Hair2Go Device
Condition: Hair Removal
Study type: Interventional

Summary: 
      The current study is a follow up study designed to gather information about the effect of the
      number of Hair2Go maintenance treatments on hair clearance 1 year after the last basic
      Hair2Go treatment. This study includes taking photos and documenting endpoints but does not
      include treatments.
    

Detailed description: 
      The Hair2Go device is intended for short-term and long-term removal of unwanted hair
      adjunctive to shaving. The device uses a technology called Elōs, which is a combination of
      electrical field at radio frequencies (RF) and intense optical energy, that are
      simultaneously applied to the tissue and were found to have synergistic effects. Thus, lower
      levels of both energies are used to facilitate the treatment for individuals of all skin
      types and hair colors.

      This study is a multicenter study. Subjects that completed the basic treatments of previous
      Hair2Go studies (OHR-2, OHR-3, or OHR-5-Face) will be offered the option to enroll in this
      study that will not include treatments. The individual data collected in the OHR-2 (and its
      extensions, i.e. OHR2-P and OHR2-1Y), OHR-3, and OHR-5-Face studies will be used for the
      analysis together with data gathered in this study. Photographs of the previously treated
      areas will be taken 3, 6, 9, and 12 months after the last basic treatment if they were not
      already taken as part of the OHR-2, one of its extensions (i.e. OHR2-P and OHR2-1Y), or
      OHR-5-Face.
    

Intervention name(s): Hair2Go
Intervention type(s): Device
Intervention description(s): Hair2Go treatment once a month for 6 months
Other intervention name(s): Mē my elōs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Influence of Collective Schemas on Individual Memory
Condition: Episodic Memory
Study type: Interventional

Summary: 
      Schemas describe mental structures storing recurrent and organized pattern of information.
      Schemas may have a strong influence on the process of storing and retrieving new information
      into memory. Previous approaches in the cognitive neuroscience of memory have entirely
      focused on the individual dimension of preexisting schemas. In the real world though, much of
      the researchers' experiences and knowledge are collective or shared. Such social-cultural
      frameworks stored in collective memory may also reshape and reconfigure the construction of
      individual memories. Attempting to ascertain the influence of collective schema on the neural
      substrates of individual memories using cutting-edge brain imaging methods represents the
      challenge that MULTIBRAIN2 seeks to tackle. To achieve this goal, the researchers will record
      brain activity during MRI scanning sessions in a group of 24 participants while they are
      performing an encoding followed by episodic memory retrieval tasks on pictures of the World
      War II Memorial of Caen. This study will seek to identify brain areas of the prefrontal
      cortex encoding the organization of knowledge in collective memory using multivariate
      analyses of brain activity patterns, and then to understand how such regions might modulate
      the recruitment of the hippocampus during episodic memory retrieval using analyses of
      effective connectivity. The organization of knowledge in collective memory is measured in
      parallel through 1) the analysis of French social memory of World War II using a corpus of
      thousand of television and radio shows from the National Institute of Audiovisual, and 2) an
      internet task measuring the organization of shared individual knowledge about World War II.
      Once collected, these data will help us to understand how collective schemas may shape the
      organization of individual memories.
    


Intervention name(s): Episodic memory task; fMRI
Intervention type(s): Behavioral; Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Dynamic Gait Index in Hemiplegic Cerebral Palsy
Condition: Cerebral Palsy; Hemiplegic Cerebral Palsy; Gait Disorders, Neurologic
MeSH terms: Paralysis; Cerebral Palsy; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Observational

Summary: 
      The purpose of this study is to assess validity and reliability of Dynamic Gait Index (DGI)
      in patients with unilateral spastic cerebral palsy
    

Detailed description: 
      Cerebral Palsy (CP) is a childhood onset, lifelong neurological disorder, attributed to
      non-progressive injury of the fetal or immature brain. It causes movement deterioration and
      activity limitation. In CP patients increase in slow walking speed, shorter step length, and
      longer duration in the double support phase are common. Such gait changes are thought to
      reflect the unbalanced walking pattern seen in these children. Although children with CP are
      well known to have poor balance and high fall incidence, little effort has been made to
      quantify the dynamic walking stability of these children.

      The Dynamic Gait Index (DGI) is a performance-based tool developed by Shumway-Cook and
      Woollacott to quantitatively measure dynamic balance capabilities. It also evaluates the
      individual's ability to modify gait in response to changing gait task requirements. Despite
      it's widespread use in the elderly population, DGI has not yet been investigated in children
      with neurological conditions. Considering that it takes a little time to apply the test, it
      may be advantageous for children in terms of simplicity and ease of administration.

      In this study the investigators aim to validate and assess interrater and test - retest
      reliabilities of Turkish version of Dynamic Gait Index in children with unilateral, spastic
      cerebral palsy.
    

Intervention name(s): Dynamic Gait Index
Intervention type(s): Other
Intervention description(s): Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        16 spastic unilateral cerebral palsy patients, between 6 - 14 years of age, and 16 healthy
        volunteer peers
Oral Health Among Children
Condition: Schoolboy
Study type: Interventional

Summary: 
      The aim of this study is to identify the knowledge and behavior on dental health and hygiene
      among adolescents. In most cases, the investigators know tooth decay can be prevented and
      reversed at an early stage by observing good oral hygiene. Few studies have been done among
      adolescents.

      This study could justify the implementation of public health actions in terms of prevention.
    


Intervention name(s): classical lecture style presentation; an intervention in the form of fun workshops; digital media intervention
Intervention type(s): Other; Other; Other
Intervention description(s): classical lecture style presentation; an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop); digital media intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Test group
Classes with a classical lecture style presentation
classes with an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop)
classes with digital media intervention
Masking: Single (Participant)
Primary purpose: Other
Effect of Aerobic Exercise on Premenstrual Syndrome Symptoms (PMS).
Condition: Premenstrual Syndrome; Quality of Life
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional

Summary: 
      To Determine the Effect of Regular Aerobic Exercise Training on Severity of Premenstrual
      Syndrome Symptoms and Health-Related Quality of life on working women.Exercise can be used as
      an alternative therapy in reducing premenstrual symptoms.But still there is lack of
      Literature on PMS in work Place and effect of Treatments to improve overall Quality of life
      in working women.And this study aims to fill the gap by assessing the impact that
      Premenstrual Syndrome can have on working women's Quality of life and can be used to
      establish a model of regular exercise program with the potential to decrease premenstrual
      symptoms and improve quality of life for a menstrual health-friendly workplace environment
      for Female Employees.
    

Detailed description: 
      A review conducted to assess the effect of 8 weeks of aerobic exercise on the non-athletic
      females facing premenstrual syndrome symptoms. The results displayed positive effects of 8
      weeks of exercise on symptoms of PMS. The aerobic exercise helped to reduce both
      psychological and physical symptoms.

      Regular swimming for 8 weeks also decreased the severity of PMS symptoms in females. Results
      deduced that the exercise improved the vascular activity of the heart, and reduced stress and
      anxiety. Moreover, it also enhanced bone density.

      In one of RCT the effect of 3 months of exercise through treadmill on PMS and hormones was
      also evaluated. It was assumed that many symptoms of PMS were reduced including the
      carbohydrate cravings, stress, and depression. The electrolyte change was also reduced.
      Exercise also reduced the proportion of backache and menstrual cramps in females.

      Another review on a balanced diet and regular exercise demonstrated that the diet rich in the
      essential nutrients and regular exercise improved the health of the females. The symptoms of
      PMS were also reduced in these females along with the intensity of dysmenorrhea.
    

Intervention name(s): Aerobic circuit training; Outdoor walk
Intervention type(s): Other; Other
Intervention description(s): Aerobic Exercise Training, 3 times a week for 8 weeks, (Tuesday, Thursday & Saturday, 24 sessions Total) 30 min each time, at 60-80 % of HR max (moderate intensity).; 30minutes Walking outside below 40% of HR max for 2 months.(3 times per week for 8 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aerobic Training
High Flow in Infants With Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      In this multi-centre randomized controlled trial the investigators compare the effect on
      dyspnoea severity of oxgen delivery through High Flow Nasal cannula with Low Flow Nasal
      Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe
      dyspnoea.
    

Detailed description: 
      In this multi-centre randomized controlled trial the investigators compare the effect on
      dyspnoea severity of oxgen delivery through High Flow Nasal Cannula with Low Flow Nasal
      Prongs in children < 2 years of age hospitalised for bronchiolitis with moderate-severe
      dyspnoea. The study will take place on the pediatric (Non intensive care) units of 5
      different hospitals in the Netherlands.
    

Intervention name(s): High Flow Nasal Cannula; Low Flow Nasal Prongs
Intervention type(s): Other; Other
Intervention description(s): Oxygen delivery through Heated Humidified High Flow Nasal Cannula; Oxygen delivery through Low Flow Nasal Prongs
Other intervention name(s): HFNC; LFNC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites
Condition: Burn; Trauma; Varicose Ulcer
MeSH terms: Varicose Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will assess the effects of Zesteem (estradiol) on the healing of split thickness
      skin graft donor sites in patients aged 18-85 years.
    


Intervention name(s): estradiol (Zesteem)
Intervention type(s): Drug
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Ultherapy for Buttock Lift
Condition: Buttock Ptosis
Study type: Interventional

Summary: 
      Up to 24 subjects will be enrolled and treated. Enrolled subjects will receive two Ulthera®
      treatments, 90 days apart. Follow-up visits will occur at 90, 180, and 270 days following the
      last treatment. Study images will be obtained pre-treatment, immediately post-treatment, and
      at each follow-up visit.
    

Detailed description: 
      This study is a prospective, single-blinded, randomized, split-body clinical study to be
      conducted at one clinical site. Investigator will assess baseline buttock ptosis to confirm
      subject eligibility.

      Enrolled subjects meeting all entrance criteria and who are confirmed to be eligible for
      study treatment will be randomized/assigned into one of two treatment groups: "Right side
      treated" and "Left side treated". All subjects will receive two, single-sided, dual-depth
      Ultherapy® treatments using the 4-4.5mm and 7-3.0mm transducers at 0.90J and 0.30J,
      respectively. Standardized images will be taken using standard 2D and Vectra 3D digital
      imaging systems. Subjects completing all study visits will be given the option of receiving
      two balancing treatments, 90 days apart, and will be required to complete one study visit at
      90 days following the last balancing treatment. Quantititative and qualititative assessment
      of pre- versus post-treatment buttock ptosis will be completed for each post-treatment time
      point. Subjects will also complete a questionnaire at each study visit.
    

Intervention name(s): Ulthera treatment
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin
Other intervention name(s): Ultherapy, Ulthera System Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulthera, Ulthera System, Ultherapy
A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of Pravastatin
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine whether the treatment with AZD1981 will
      affect the pharmacokinetics of pravastatin.
    


Intervention name(s): AZD1981; AZD1981; pravastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg per oral, twice daily for 8 days; 4x100 mg per oral, twice daily for 8 days; 40 mg, once daily at Day 1, period A and Day 8, period B
Other intervention name(s): pravachol
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Drug-Drug interaction; pravastatin; AZD1981; The pharmacokinetics resulting from AZD1981 and pravastatin interaction; The effects of taking a combination of AZD1981 and pravastatin