bioihbjkbjnl/mcl2 huggingface dataset:
Drug Interaction Study of Simvastatin and Dabigatran
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to evaluate the effect of simvastatin on the pharmacokinetics and
      pharmacodynamics of dabigatran in healthy male adults
    

Detailed description: 
      Pharmacokinetics and pharmacodynamics of dabigatran without coadministration of simvastatin
      will be compared with those after multiple administration of simvastatin.
    

Intervention name(s): Simvastatin, Dabigatran Etexilate
Intervention type(s): Drug
Intervention description(s): The subjects receive dabigatran etexilate with and without simvastatin administration
Intervention MeSH terms: Dabigatran; Simvastatin
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction
Condition: Vasculogenic Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      This is a prospective, randomized, double-blind clinical study for assessing the safety and
      efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.
    

Detailed description: 
      This is a prospective, randomized, double-blind clinical study comparing safety and efficacy
      of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety
      and efficacy of the control sham patients. Patients are randomized in a 1:1 ratio of Renova
      to the sham control group.
    

Intervention name(s): Shockwave system; Sham treatment
Intervention type(s): Device; Device
Intervention description(s): Sham treatment that looks, sounds and feels like real LI-ESWT treatment by Renova.
Other intervention name(s): Renova
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Low Intensity Shockwave; Extracorporeal shockwave therapy; Erectile dysfunction
The Effects of Caffeine and L-theanine Both Alone and in Combination on Cerebral Blood Flow, Cognition and Mood
Condition: Cognitive Function; Mood
Study type: Interventional
Phase: Phase 4

Summary: 
      Although the beneficial effects of caffeine on cognition and mood have been reported in a
      number of studies, relatively few studies have looked at the effects of caffeine in
      combination with other phytonutrients despite the fact that caffeine is seldom consumed in
      isolation. L-theanine is a naturally occurring amino-acid found in tea, and has been used
      historically as a relaxing agent (Haskell et al., 2008). Few have assessed the impact of
      l-theanine on cognition, but of those that have, the most interesting results were obtained
      when l-theanine was assessed in combination with caffeine (Haskell et al., 2008). It remains
      unclear what is underlying the reported effects.

      Near Infrared Spectroscopy (NIRS) is an emerging neuroimaging technology that is capable of
      determining changes in cerebral blood flow (CBF) by measuring the optical properties of
      oxygenated and deoxygenated blood (Bunce et al., 2006). No study to date has used NIRS to
      assess cerebral blood flow following treatment with either caffeine, l-theanine or a
      combination of both. It is anticipated that the proposed study will provide some insight into
      the mechanism of the previously observed effects both alone and in combination.

      A randomised, double-blind, placebo controlled, balanced crossover design study will assess
      the effects of 75mg caffeine, 50mg l-theanine and a 75mg caffeine/50mg l-theanine combination
      in 24 young healthy adults (18-35). Cognitive and mood assessments will take place at
      baseline and at 30 minutes following treatment whilst cerebral haemodynamics are measured via
      the technique of NIRS.
    


Intervention name(s): Caffeine and L-theanine
Intervention type(s): Dietary Supplement
Intervention description(s): Acute oral administration of 75mg of caffeine, 50mg l-theanine, 75mg caffeine and 50mg l-theanine in combination or placebo. One dosage administered on each of four separate study days.
Other intervention name(s): Sun-theanine (l-theanine)
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Caffeine; Ltheanine; Near Infrared Spectroscopy; Cerebral Blood Flow; Cognitive Function; Mood
Serum and Uterine Progesterone Levels and ERA Test.
Condition: Endometrial Receptivity
Study type: Observational

Summary: 
      Since the implantation is related with endometrial receptivity, the patient specific plasma
      progesterone concentration influences this pattern.

      Following this hypothesis, the study establishes a correlation between the serum progesterone
      measured on the day of the endometrial biopsy and the endometrial receptivity with the ERA
      test.
    

Detailed description: 
      In patients who have had problems of assisted reproduction it is essential to establish the
      factors that contribute to the success of a cycle: correcting these factors means increasing
      the possibility of the cycle culminating in pregnancy.

      In patients with embryonic implantation failures, a prevalence of non-receptive endometrium
      has been described after performing the ERA test of around 20%. On the other hand, a study
      that shows embryonic generation values below a certain threshold (25th percentile), presents
      a rate of evolutionary clinical gestation and lower embryo implantation.

      It is logical to think that progesterone levels are lower than the state of endometrial
      receptivity, since the hormone is responsible for the endothelial changes that prepare the
      uterus for implantation. It is ERA. The result of this study is the result of the evaluation
      of the lifetime of the endometrial biopsy is related to the result of the same.

      If desired, the determination of the probability of the day of the transfer is predictive of
      the pregnancy rate through the impact that the hormone has on the endometrial receptivity.
      This would allow to decide in the same cycle, if the patient should be in a transfer to
      another dimension, or should it defer to another cycle where obtain the optimal values of
      progesterone.

      Nowadays, there are no publications in the literature that have related the concentration of
      progesterone with endometrial receptivity through ERA. This is the first prospective study
      that analyzes this relationship.

      The ERA test has been chosen for the evaluation of endometrial receptivity, which is a tool
      that has been widely used and used in the usual clinical practice of our clinic.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infertile patients with background of failed IVF cycles in which an endometrial receptivity
        test (ERA test) is performed in the context of an artificial cycle.
      
Biospecimen description: 
      Endometrial biopsies, Blood sample
    
Keywords: progesterone; artificial endometrial preparation cycle; endometrial receptivity
Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer
Condition: Postoperative Stage II/III Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of ART-123 for the
      prevention of cancer treatment related symptoms in patients with postoperative stage II / III
      colon cancer.
    


Intervention name(s): ART-123 (3-day ART); ART-123 (1-day ART); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ART-123 380 U/kg infusion once daily on days 1-3 in each cycle; ART-123 380 U/kg infusion once on day 1 and placebo infusion once daily on days 2-3 in each cycle; Placebo infusion once daily on days 1-3 in each cycle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess steady state pharmacokinetics (PK), safety and tolerability between AVP-786
      (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) and paroxetine and
      between AVP-786 and duloxetine.
    


Intervention name(s): AVP-786; Paroxetine; Duloxetine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Duloxetine Hydrochloride; Paroxetine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug-drug interaction; Pharmacokinetics; Healthy Volunteers; deuterated dextromethorphan; deuterated dextromethorphan with quinidine
Development and Evaluation of a Cognitive Enhancement Product Made From Selected Thai Herbs for Menopausal Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is set up to determine the cognitive enhancing effect and consumption safety of
      the novel cognitive enhancement product made from the combined extract of Z. mays (purple
      color) and P. amaryllifolius based-drink (MP1) in menopausal volunteer.
    

Detailed description: 
      Memory impairment is one of the common health problems in menopausal women. Due to the
      therapeutic efficiency limitation, the searching for the protective intervention for this
      condition is required. Based on the previous findings that the combined extract of Z. mays
      (purple color) and P. amaryllifolius based-drink (MP1) could attenuate memory impairment in
      animal model of menopause, the investigators aimed to investigate the effect of MP1
      functional drink on working memory, psychological fitness, possible underlying mechanism and
      the consumption safety in menopausal volunteers.
    

Intervention name(s): MP1; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Subjects receive MP1 drink at the dose of 400 mg/day after meal for 8 weeks.; Subjects receive Placebo drink after meal for 8 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: MP1; cognitive enhancing effect; menopausal women
Improving Sleep Among Cancer Patients: Comparison Between Physical Activity and Self-administered Cognitive-behavioral Therapy (CBT)
Condition: Cancer; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      It has been suggested that the practice of physical exercise can improve sleep, but few
      studies have investigated this issue in the context of cancer, despite the proven benefits of
      exercise in this population. This randomized-controlled trial (RCT) aimed to compare the
      efficacy of an aerobic intervention program to that of a self-administered
      cognitive-behavioral therapy (CBT) to improve sleep of cancer patients. Forty-one men and
      women with insomnia symptoms and treated within 6 months for a non-metastatic cancer
      participated in the study.
    


Intervention name(s): Physical exercise; Cognitive-behavioral therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individualized aerobic intervention program; Psychological intervention combining behavioral, cognitive, and educational strategies
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cancer; insomnia; sleep; physical exercise; aerobic; cognitive-behavioral therapy; self-help; RCT
Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy
Condition: Ketamine; Levobupivacaine; Paravertebral Block; Acute Pain; Chronic Pain
MeSH terms: Chronic Pain; Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the role of adding ketamine to levobupivacaine in PVB on acute and chronic pain
      in thoracotomy
    

Detailed description: 
      Several adjuvants have been added to them to enhance the effects of those blocks.
      Dexamethasone, morphine, dexmedetomidine, clonidine, ketamine, and magnesium sulphate are
      some of them. results are variable.

      Ketamine blocks N-Methyl-D-Aspartate (NMDA) receptors in the spinal cord. It is also
      considered to influence voltage sensitive Calcium ions channels, opioid receptors, and
      monoaminergic receptors. Therefore, it is considered overall to affect nociception.
    

Intervention name(s): Ketamine + Levobupivacaine; Levobupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Skin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with 1ml ketamine (50mg); Skin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with (50mg) or normal saline
Intervention MeSH terms: Ketamine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport.
      Despite ongoing research, there is no highly sensitive clinical test for cognitive function.
      This makes the clinical diagnosis of concussion particularly difficult as the clinical
      presentation of concussion is highly variable with symptoms often evolving over time. Given
      the variability in concussion presentations, there is no single test that can diagnose a
      concussion. Current recommendations are that sports medicine providers apply a multifaceted
      concussion assessment battery that combines subjective symptoms, motor control and cognitive
      assessment.

      This investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in
      detecting and managing concussive injuries. This study will establish the reliability of BNA™
      scores over clinically relevant assessment intervals and investigate the effect of SRC and
      sub-concussive head impacts on BNA scores.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Phase 1: gender-balanced groups of 30 healthy high school (14-17 years old) and 30 healthy
        college aged (18-26 years old) individuals who participate in non-contact sports Phase 2a:
        30 high school and/or collegiate athletes aged 14-26 years with concussion and 30 matched
        control athletes.

        Phase 2b: at least 30 high school and/or collegiate contact sport athletes aged 14-26 years
        whose head impacts are monitored during games and practices.
      
Keywords: mild Traumatic Brain Injury; mTBI; Concussion
Acute Effects of Action Observation on Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study aims to assess the immediate effects of action observation therapy on the cervical
      muscles' strength, pain intensity, tactile acuity and pain pressure threshold in individuals
      with chronic nonspecific neck pain.
    

Detailed description: 
      This study is a randomized controlled trial with two arms: action observation group vs
      control group. The action observation group will be asked to watch videos of neck exercises
      with full attention and concentration and not perform any motion or execute any movement
      during the observation time. The control group will be asked to watch videos of a landscape.

      Participants will be assessed at baseline and at post-intervention for muscle strength, pain
      intensity, pressure pain threshold and tactile acuity.
    

Intervention name(s): Action-observation therapy; Placebo
Intervention type(s): Other; Other
Intervention description(s): Action observation therapy involves the observation and perception of human movement performed by others. The observation of actions performed by others activates in the perceiver the same neural structures responsible for the actual execution of those same actions.; Participants will watch a natural landscape without any human.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acceptability and Effectiveness of Household Water Treatment in Reducing Diarrhea Among Under Five Children
Condition: Acute Diarrhoea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      The Millenium development goals (MDGs) call for reducing by half the proportion of people
      without sustainable access to safe drinking water. This goal was adopted in large part
      because safe drinking water has been seen as critical to fighting diarrheal disease. Source
      protection is considered the main intervention area to achieve this goal. However, research
      worldwide that has shown that even drinking water which is safe at the source is subject to
      frequent and extensive fecal contamination during collection, storage and use in the home.
      This contamination is through the introduction of cups, dippers or hands, contamination by
      flies, cockroaches, and rats. Even piped water supplies of adequate microbial quality can
      pose infectious disease risks if they become contaminated due to unsanitary collection,
      storage conditions and practices within households.

      To reduce this problem, point-of-use water treatment has been advocated as a means to
      substantially decrease the global burden of diarrhea and to contribute to the MDGs. However,
      research indicates that there are many unanswered questions around Household water treatment
      (HWT) that require small or medium scale epidemiological studies and randomized controlled
      trials, especially with regard to effectiveness, acceptability and identifying suitable
      target populations. Some of the most urgent questions to be resolved are:(1) How much of the
      currently cited disease reduction of HWT is due to bias? (2) What is the effect of HWT on
      nutritional status (weight gain and growth)?(3) At which populations should HWT be targeted?
      (4) Is it acceptable and sustainable in poor communities where the risk of diarrheal disease
      is high.

      hypothesis: Do household water treatment with chlorine reduce diarrhea among underfive
      children? hypothesis: Do household water treatment with chlorine acceptable in the community?
    


Intervention name(s): household water treatment
Intervention type(s): Other
Intervention description(s): household water treatment with 1.25% sodium hypochlorite
Other intervention name(s): 1.25% sodium hypochlorite
Intervention MeSH terms: Sodium Hypochlorite; Eusol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: three or more loss stools in 24 hours
Rehabilitating Muscle After Intensive Care
Condition: Recovery From Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      The study will examine the effect of amino acid supplements and enhanced physiotherapy on
      physical recovery following critical illness in intensive care.
    

Detailed description: 
      Critically ill patients aged 45 years and over will be recruited during recovery after
      intensive care. Using a randomised controlled, blind at follow-up design the study will
      examine whether the combination of an amino acid supplement and an enhanced physiotherapy
      programme improve the rehabilitation of muscle following intensive care better than a
      self-guided rehabilitation programme alone or with either an amino acid supplement or the
      enhanced physiotherapy programme. The Primary efficacy outcome will be the improvement in six
      minute walking test measured at 3 months post intensive care discharge. Secondary efficacy
      parameters will be insulin resistance, health related quality of life and muscle mass using
      DEXA scanning at 3 months and 1 year post intensive care discharge.
    

Intervention name(s): Amino acid supplement; PEPSE; Intensive Care Unit (ICU) Recovery Manual; Placebo nutritional supplement
Intervention type(s): Dietary Supplement; Other; Other; Dietary Supplement
Intervention description(s): Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months; Enhanced physiotherapy programme of 3 1 hour sessions per week for 6 weeks while in hospital and once discharged home 1 supervised outpatient session of 1 hour and 2 home exercise sessions per week (PEPSE).; Standard self-directed 6 week rehabilitation package; Cherry flavoured low calorie and low protein placebo drink
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Intensive Care; Critical illness; Physiotherapy; Nutritional supplementation