bioihbjkbjnl/mcl2 huggingface dataset:
Safety And Tolerability Study Of BID Titration Scheme With PF-05089771
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The most notable tolerability finding from these multiple dosing studies has been the
      occurrence of mild to moderate rash at doses of 450 mg BID and 600 mg BID. Based upon this
      finding, the current four week study is designed to examine whether a slow titration regimen
      up to a lower maintenance dose of 450 mg BID is able to reduce the incidence of rash.
    


Intervention name(s): PF-05089771; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): titration from 150mg BID to 450mg BID; matched placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4451
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single ascending dose study to assess the safety, tolerability and pharmacokinetics
      of AZD4451.
    


Intervention name(s): AZD4451; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg capsules, 5 mg capsules, and 25 mg capsules; 1 mg capsules, 5 mg capsules, and 25 mg capsules
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: AZD4451; Bipolar; depression
COMFORT: A Multicenter, Open-label, Randomized, Crossover Study
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate pain the patient experienced following treatment of
      varicose veins with Varithena® compared to radiofrequency ablation.
    

Detailed description: 
      A study that evaluates pain following treatment of varicose veins in patients treated with
      Varithena® and those treated with RFA.
    

Intervention name(s): Varithena®; Radiofrequency ablation
Intervention type(s): Drug; Device
Intervention description(s): Varithena® treatment in accordance with full prescribing information and instructions for use; Radiofrequency ablation conducted per physicians' standard of care.
Other intervention name(s): Polidocanol Solution, 180 mg/18 mL (10 mg/mL); RFA
Intervention MeSH terms: Polidocanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
L-arginine Therapy on Endothelium-dependent Vasodilation & Mitochondrial Metabolism in MELAS Syndrome
Condition: MELAS Syndrome
MeSH terms: MELAS Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      MELAS patients suffer from exercise intolerance, weakness, poor vision or blindness, poor
      growth, developmental delay, and deafness. They also have unique 'stroke-like' episodes
      (SLEs) which are not due to blockages of large or medium arteries. These 'strokes' are
      thought to be due to energy failure of very small brain blood vessels combined with energy
      failure in the mitochondria (cell battery) of the brain cells, especially in the back region
      of the brain in the vision centre. This leads to visual loss and paralysis. The overall goal
      of this study is to better understand the mechanism of these SLEs at the level of the brain
      cells and small blood vessels.
    

Detailed description: 
      We will study a family of 3 siblings, each with different severities of MELAS, using safe,
      non-invasive tests. We will determine whether there is a decrease in the ability of small
      brain blood vessels to increase blood flow by dilating in response to certain stimuli such as
      increased blood carbon dioxide levels or in response to brain cell activation in the vision
      centre by visual stimuli. We will use a technique called BOLD-fMRI which can detect changes
      in brain blood flow. As exercising muscle also depends on increased blood flow and
      mitochondrial energy, we will study different measures of aerobic energy metabolism in
      exercising muscle using cycle exercise testing and special phosphorus-magnetic resonance
      spectroscopy which measures the changes in the major chemicals of muscle energy metabolism.
      The dietary amino acid L-arginine is known to dilate blood vessels increasing blood flow and
      to decrease toxic free radicals that are generated by dysfunctional mitochondria. We will
      determine the effect of a single dose and a 6 week trial of oral L-arginine, on brain blood
      vessel reactivity, brain cell activation and muscle aerobic function to see how useful this
      would be in the treatment of these patients and other mitochondrial disorders which present
      with strokes.
    

Intervention name(s): L-Arginine
Intervention type(s): Drug
Intervention description(s): NOW® L-Arginine powder
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; MELAS; mechanism of action of L-arginine
Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
Condition: Hypertension and Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing
      clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of
      Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers
    


Intervention name(s): Telmisartan; Amlodipine; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amlodipine; Telmisartan; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care.
Condition: Polytrauma; Traumatic Hemorrhage
MeSH terms: Hemorrhage; Multiple Trauma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This
      study compares presence of Trauma Induced Coagulopathy (TIC) and acute traumatic hemorrhage
      treatment at pre-hospital phase of care with red blood cells (RBC), Tranexamic acid (TXA) and
      Fibrinogen Concentrate (FC) with the current treatment based on the administration of
      Crystalloids and TXA.
    

Detailed description: 
      A pilot, non-randomized, open-label study of two intervention arms and controlled with the
      standard treatment in which 60 patients affected with acute hemorrhage due to severe trauma
      will enter the study with the main objective of evaluating the feasibility and the efficacy
      of early treatment during the pre-hospital care phase with packed red blood cells, fibrinogen
      concentrate and tranexamic acid (experimental arm) compared to the standard treatment based
      on crystalloids administration and tranexamic acid (control arm). The secondary objectives
      are to evaluate the safety and clinical evolution of the patients. Prior to the
      administration of the treatment, 2 blood samples will be extracted in both groups in order to
      compare the coagulation status and to be able to perform the pre-transfusion tests. On
      arrival at the hospital, another sample will be taken to compare changes in coagulation after
      the administration of the experimental or standard treatment and also between both groups.
      The assessment of the coagulation status will be made using the values provided by the
      viscoelastic test (TEG6s). The experimental and standard treatment will be administered
      endovenously. After treatment, patients will be evaluated up to 30 days.
    

Intervention name(s): Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]; Red blood cells concentrate; Tranexamic Acid
Intervention type(s): Drug; Biological; Drug
Intervention description(s): Administration of 2 mg of FC together with RBC and TXA; Administration of 2 red blood cells concentrates together with FC and TXA; Administration of 1g of TXA together with FC and RBC
Intervention MeSH terms: Tranexamic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, non-randomized, open-label, two-arms, controlled pilot clinical trial.
The experimental and control arms will be determined according to the SEM units with RBC, TXA and FC administration capacity (i.e. helicopter unit, rapid intervention ambulance or advanced life support ambulance). The emergency SEM units are activated according current protocols based on distance, severity and weather conditions.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polytrauma; Red blood cells transfusion; Acute traumatic hemorrhage
Human Intestinal Amino Acid Absorption and the Role of a Local RAS
Condition: Renin-Angiotensin Aldosterone System (RAS)
Study type: Observational

Summary: 
      This study is to find out what role a local intestinal RAS (renin angiotensin system) plays
      in the context of amino acid absorption in the human intestinal tract and how this RAS and
      thus the amino acid absorption is influenced by the RAS-active drugs (angiotensin II AT1
      receptor blockers (sartans) or ACE inhibitors).
    


Intervention name(s): biopsy of intestinal tissue; blood draw; urine collection
Intervention type(s): Other; Other; Other
Intervention description(s): 4 intestinal tissue biopsies taken from descending Duodenum, 2 intestinal tissue biopsies taken from Ileum, 2 intestinal tissue biopsies taken from ascending colon (additional to routine biopsies taken for gastrointestinal diagnostic); 40 ml blood draw (in Heparin blood tubes) (additional to routine blood draw taken for gastrointestinal diagnostic); Midstream Urine collection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undertaking a gastroscopy and / or colonoscopy for a medical indication
      
Biospecimen description: 
      intestinal tissue samples blood samples
    
Keywords: Renin Angiotensin System; Angiotensin Converting Enzyme 2 (ACE2); Angiotensin II AT1 Receptor Blocker; ACE inhibitors; intestinal amino acid absorption
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Condition: Mitral Regurgitation; Mitral Insufficiency
MeSH terms: Mitral Valve Insufficiency
Study type: Observational

Summary: 
      Single-center clinical investigation is to evaluate long-term safety and performance of the
      Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV)
      surgery using Medtentia's MAR system in clinical investigation 2010-040 performed during June
      2011 - April 2016.
    


Intervention name(s): Medtentia Annuloplasty Ring (MAR)
Intervention type(s): Device
Intervention description(s): Mitral valve repair using the MAR performed in clinical investigation 2010-040
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects, who underwent mitral valve repair operation with successful MAR implantation in
        clinical investigation 2010-040.
      
Keywords: Mitral valve; Mitral surgery; Mitral repair; Mitral annuloplasty; Mitral valve surgery; Mitral valve repair; Mitral valve annuloplasty
Digestive Properties of Carbohydrate-based Foods
Condition: Obesity; Diabetes Mellitus, Type 2; Appetitive Behavior
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Gastric emptying rate, glycemic response, fermentation, and appetitive response are being
      assessed after consumption of traditional West African carbohydrate-based foods (pearl millet
      couscous, pearl millet thick porridge) and Western type carbohydrate-based foods (wheat
      couscous, white rice).
    

Detailed description: 
      Anecdotal evidence suggests that couscous made from pearl millet (Pennisetum glaucum), hereby
      referred to as millet couscous, is highly satiating in populations living in the West African
      Sahel. Results from a previous human study conducted the investigators indicated that
      traditional West African foods made from pearl millet and sorghum (millet couscous, millet
      thick porridge, and sorghum thick porridge) exhibit markedly delayed rates of gastric
      emptying compared to Western foods (pasta, boiled potatoes, and white rice) in a population
      from Mali, Africa. The delayed gastric emptying rate of the thick porridges can be attributed
      at least partially to the impact of viscosity, while the cause of the delayed gastric
      emptying rate of the millet couscous remains unclear. The overall aim of this research is to
      determine why millet couscous exhibits a delayed rate of gastric emptying, while also
      assessing other digestive properties to gain a better understanding of the factors that could
      be contributing to this outcome. Therefore, gastric emptying rate, glycemic response,
      fermentation, and appetitive response are all being assessed for West African and Western
      foods in a population residing in the United States.
    

Intervention name(s): Pearl millet couscous - made in Senegal; Pearl millet couscous - made in USA; Pearl millet thick porridge; Wheat couscous; White rice
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Pearl millet couscous (made in Senegal) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.; Pearl millet couscous (made in USA) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.; Pearl millet thick porridge was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.; Wheat couscous was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.; White rice was tested as a comparator for gastric emptying rate, glycemic response, fermentability, and appetitive response.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to evaluate the therapeutic equivalence and safety.
    

Detailed description: 
      The objectives of this study are to evaluate the therapeutic equivalence and safety of the
      test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product
      Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne
      vulgaris and to demonstrate the superiority of the efficacy of these test and reference
      products over the placebo control.
    

Intervention name(s): Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%; Onexton™ Gel; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.); Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC); Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
Other intervention name(s): Clindamycin, BPO; Clindamycin, BPO; Vehicle
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dynamic Stability Exercises in Patients With Hypermobile Ehlers-Danlos Syndrome and Hypermobility Spectrum Disorder
Condition: Hypermobility Syndrome; Hypermobile Ehlers-Danlos Syndrome
MeSH terms: Ehlers-Danlos Syndrome; Syndrome
Study type: Interventional

Summary: 
      Background:

      Symptomatic hypermobility may lead to a number of restrictions in daily life. So far, there
      is a lack of effective treatments. A whole-body dynamic stability exercise intervention
      targets to stimulate the dynamic stability and activation of the proprioceptive system and
      thereby intends to improve patients' health. The aim of the current study was to examine the
      feasibility, acceptability and impact of a whole-body dynamic stability exercise intervention
      in patients with hypermobile Ehlers-Danlos syndrome and hypermobility spectrum disorder.

      The aim of the current study was to examine the feasibility, acceptability and impact of a
      dynamic stability exercise intervention in patients with hypermobile Ehlers-Danlos syndrome
      and hypermobility spectrum disorder.

      Methods:

      This is a mixed-methods feasibility study. Fifteen patients (14 women and 1 man) with
      hypermobile Ehlers-Danlos syndrome or hypermobility spectrum disorder and chronic pain were
      recruited from two pain specialist clinics in the South-East of Sweden. A dynamic stability
      exercise program for daily home-exercise was applied during five physiotherapist led sessions
      distributed over seven weeks. Patient reported outcome measures (PROMs) included pain and
      function, psychological well-being and quality of life. The clinical tests included walking
      and balance. Through qualitative interviews patients and physiotherapists described their
      experiences of the assessments and intervention. Assessments were done at baseline, after the
      intervention, and at the 3-month follow-up.
    

Detailed description: 
      The specific research questions are:

        1. Do retention rates, adherence rates and adverse events allow continuation to a large
           scale RCT?

        2. What are the tendencies of impact of the exercise program on pain, function,
           psychological well-being and quality of life?

        3. Which of the outcome measures used are appropriate and acceptable?

        4. What are the patients' and physiotherapists' experiences of the exercise program and
           protocol.
    

Intervention name(s): Dynamic stability exercises
Intervention type(s): Behavioral
Intervention description(s): A dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypermobility, exercise intervention, feasibility study, EDS
A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      The study population will consist of 3 mutually-exclusive sets of patients and subjects:

        -  TBI patients with intracranial bleeding

        -  TBI patients without intracranial bleeding

        -  Control subjects with normal brain health.

      Research subjects between the ages of 22 to 50 will be enrolled. All TBI patients must have a
      diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial
      bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤
      14. Total maximum duration of active monitoring with the device in this study is 48 hours
      with a clinical follow-up at day 7 after enrollment.
    


Intervention name(s): SDx3
Intervention type(s): Device
Intervention description(s): The SENSE Device (SDx3) is a non-invasive device that detects differences in the absorption of transmitted RF energy across the skull and brain and is intended to be used to evaluate intracranial hemorrhage.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of 3 mutually-exclusive sets of patients and subjects:

          -  TBI patients with intracranial bleeding

          -  TBI patients without intracranial bleeding

          -  Control subjects with normal brain health.

        Research subjects between the ages of 22 to 50 will be enrolled. All TBI patients must have
        a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial
        bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤
        14.
Total Knee Arthroplasty (TKA) Cemented Versus Cementless Tibial Prosthesis Study
Condition: Osteoarthritis; Post-traumatic Osteoarthritis; Rheumatoid Arthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The primary purpose of TKA Randomized Clinical Trial- Cemented versus Cementless Tibial
      Prosthesis Study will determine whether there is a significant difference in patient-reported
      and measured clinical outcomes (e.g. pain, function, length of recovery, and patient
      satisfaction) between subjects treated with a cementless tibial prosthesis (the cementless
      group) and those treated with cemented tibial prosthesis (the cement group) over the first
      two postoperative years. Radiographs will be assessed before surgery and at established
      post-operative intervals to determine if there are any significant differences between
      patients in the two groups and to assess the influence of component fixation on radiographic
      stability over time. Complication and revision rates will also be assessed for comparison.
    


Intervention name(s): Cemented Tibia; Cementless Tibia
Intervention type(s): Procedure; Procedure
Intervention description(s): Total knee arthroplasty with cemented or cemented tibia, and post operative clinical outcome tracking; Assessing the clinical outcomes of the different type of fixation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment