bioihbjkbjnl/mcl2 huggingface dataset:
Computer-based Cognitive Training for Individuals With Parkinson's Disease
Condition: Parkinson's Disease; Mild Cognitive Impairment
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Computer-Based Cognitive Training for Individuals with Parkinson's Disease" is a 3-arm
      randomized controlled trial (RCT) comparing Brain Fitness, InSight, and an active control
      (AC) training program to evaluate the feasibility of empirically supported computer-based
      cognitive training programs (CCTPs) for patients diagnosed with Parkinson's disease (PD) with
      Mild Cognitive Impairment (MCI). This pilot study aims to address the need for increased
      interventions to target non-motor symptoms associated with PD.
    

Detailed description: 
      Patients meeting criteria for MCI will be initially randomized to one of the 3 conditions.
      Participants will complete cognitive training exercises on their home or clinic-provided
      computers for 60 minutes per day, 5 days per week. Compliance and performance will be
      monitored on a weekly basis and at completion of the study. Outcome measures will be
      collected one week before initiation of the intervention and within one week completion of
      the intervention. Neuropsychological functioning, including tests of processing speed,
      attention, and executive functioning, will serve as primary outcome measures. Patient
      reported outcomes, including measures of overall QOL and disease-specific QOL, and
      support-person reported outcomes (if applicable), including measures of overall QOL and
      caregiver burden, will be secondary outcome measures. This pilot study promises to evaluate
      computer-based cognitive training in a novel population and expand access to cognitive
      rehabilitation services, and is designed to improve cognitive functioning and QOL among a
      wide range of individuals with PD.
    

Intervention name(s): Brain Fitness; InSight; Active Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Brain Fitness is a computer-based cognitive training programs that consists of six types of exercises that train auditory processing speed and accuracy.; InSight is a computer-based cognitive training program that consists of five types of exercises that train visual processing and working memory.; The Active Control arm is a computerized learning program that consists of five programs (i.e., Wright Brothers, History of Britain, Sister Wendy's American Collection, In Search of Shakespeare, and View the Cosmos) designed to improve knowledge about literature, art, and history.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Mild Cognitive Impairment
Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea
Condition: Migraine Disorders
MeSH terms: Migraine Disorders; Dysmenorrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to determine efficacy of TREXIMA compared to placebo for the
      treatment of a menstrual migraine.
    

Detailed description: 
      A randomized, double-blind, single migraine attack, placebo-controlled, parallel group,
      multicenter study to evaluate the efficacy and tolerability of TREXIMA* (sumatriptan
      succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of
      menstrual migraine in women with dysmenorrhea. (TREXIMET was formerly known as TREXIMA)
    

Intervention name(s): sumatriptan succinate/naproxen sodium; placebo
Intervention type(s): Drug; Drug
Intervention description(s): placebo to match
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: menstrual migraine; headache; early intervention; dysmenorrhea
Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional

Summary: 
      The study will be double blind with respect to rifaximin, and randomization will be performed
      using tables of computer-generated random numbers. All subjects will be followed up till the
      recovery of HE (primary end point) or 10 days whichever is earlier. In the Lactulose group
      (group A) patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient
      passes 2-3 semisoft stools per day along with placebo . In the lactulose plus rifaximin group
      (group B) patients will receive cap rifaximin 400mg three times a day along with lactulose.
      Primary endpoints will be recovery of overt HE patients who will not recover from HE after 10
      days will be continued on the same treatment. Total duration of the study is 1 year.
    


Intervention name(s): Rifaximin plus lactulose; Lactulose
Intervention type(s): Drug; Drug
Intervention description(s): Rifaximin 400 mg three times a day Lactulose 30-60 ml in two or three divided doses.; Lactulose 30-60 ml in two or three divided doses.
Intervention MeSH terms: Rifaximin; Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Addition of Probiotic Consumption to a Nutritional Intervention and Caloric Restriction on Body Weight and Composition in Overweight Participants
Condition: Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      Limited interventional human studies suggest that probiotic supplementation may be a
      beneficial strategy for promoting weight loss when added to a nutritional intervention via
      their effects on lipid absorption and metabolic signaling molecules. The purpose of this
      study is to evaluate the effects of addition of a probiotic supplementation to a weight loss
      intervention on body weight, body composition and overall health in overweight adults.
    


Intervention name(s): Weight loss; Probiotic Formula; Placebos
Intervention type(s): Other; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the
      liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy
      men and women. The main breakdown product is Lu AG06988.
    

Detailed description: 
      Two sequence study where Lu AG06466 will be dosed with and without food, Sequence 1 and
      Sequence 2. Each subject will receive single oral doses of Lu AG06466. Subject will be
      randomized to one of two sequences.

      For inhibition of CYP3A4, each subject will receive a once daily dosage of itraconazole from
      Day 5 to Day 11.
    

Intervention name(s): Lu AG06466; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): hard capsules, orally, single doses; 200 and 300 mg, capsules, orally
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pilot Study of Biomarkers for Spinal Muscular Atrophy
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Observational

Summary: 
      The goal of this pilot study is to identify a marker or panel of markers in the blood or
      urine from a wide range of Spinal Muscular Atrophy (SMA) patients that segregates with
      measures of clinical severity. From this identification of candidate biomarkers, it is hoped
      that further investigations, both longitudinal natural history and clinical efficacy studies,
      will verify a biomarker with the sensitivity and specificity that will allow its eventual use
      as a validated pharmacodynamic marker or surrogate endpoint. In addition, this effort may
      elucidate biological pathways that may be potential therapeutic targets.
    

Detailed description: 
      Spinal Muscular Atrophy (SMA) is one of the two most common inherited children's
      neuromuscular disorders. There currently is no cure and no therapeutics approved to slow
      progression of the disease. SMA is characterized by a loss of alpha motor neurons in the
      spinal cord, severe atrophy of proximal muscles and progressive debility and disability due
      to respiratory, gastrointestinal and functional complications of the disease.

      Although SMA is a relatively common orphan disease, recruitment of patients for the number of
      candidate therapies is expected to become rate-limiting for the development of therapeutics.

      STUDY OBJECTIVES

      Primary:

        -  To identify candidate blood and urine biochemical markers that correlate with disease
           severity as determined by the Modified Hammersmith Functional Motor Scale across a range
           of type I, type II and type III children with Spinal Muscular Atrophy (SMA) (1).

      Secondary:

        -  To determine if there are biomarkers from types I-III SMA patients that correlate with
           SMA type, age at disease onset, 10-meter Timed Walk Test (ambulatory subjects only),
           pulmonary function, nutritional assessment, SMN protein level, SMN transcript level or
           SMN2 copy number.

        -  To determine if identified candidate biomarkers are associated with the disease state
           through comparison of SMA specimens with control volunteer specimens.

        -  To determine if there are potential biochemical pathways that may represent targets for
           therapeutic intervention in SMA.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children's Hospitals Unviersity Hospitals
      
Biospecimen description: 
      Whole blood, plasma, PBMCs, and urine
    
Keywords: Spinal Muscular Atrophy; Blood Biomarkers; Urine Biomarkers; Type I Spinal Muscular Atrophy; Type II Spinal Muscular Atrophy; Type III Spinal Muscular Atrophy; Modified Hammersmith Functional Motor Scale; Disease severity; Biomarkers
Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction
Condition: ACL Reconstruction
Study type: Interventional

Summary: 
      This was a prospective, multicenter, randomized, open-label, phase IV trial to compare the
      efficacy of supplementation with plasma proteins, hydrolyzed collagen (CH), a complex of
      HA-CS (HC-15), and vitamin C combined with a standard rehabilitation protocol versus the
      standard rehabilitation protocol only after arthroscopically-assisted functional ACL
      reconstruction with hamstrings.
    


Intervention name(s): PROGEN
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anterior Cruciate Ligament Tears; Dietary Supplementations; Plasma Rich Proteins; Collagen; Chondroitin Sulfate; Hyaluronic Acid
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      To evaluate the role of Inhibin A as bio marker for the number of mature oocytes, compared to
      Estradiol
    

Detailed description: 
      Inhibin A could be an improved biomarker regarding the number of expected mature oocytes
      compared to estradiol.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing ovarian stimulation for IVF treatment
      
Biospecimen description: 
      Blood extraction
Analgesic Efficacy of Trans-muscular Quadratus Lumborum Block After Unilateral Inguinal Hernia Repair
Condition: Postoperative Pain; Ultrasound Guided Nerve Block
MeSH terms: Pain, Postoperative; Hernia, Inguinal
Study type: Interventional

Summary: 
      A significant component of pain experienced after abdominal surgery is related to incision of
      the abdominal wall and adequate analgesia can be a challenge.

      The ultrasound-guided (USG) quadratus lumborum block QLB was first described by Rafael Blanco
      in a presentation at ESRA 2007 at the XXVI Annual ESRA Congress in Valencia, Spain. Blanco
      described a potential space posterior to the abdominal wall muscles and lateral to the
      quadratus lumborum muscle where Local anesthetics can be injected. This technique provide
      analgesia after abdominal surgery due to spread of LA from its lumbar deposition cranially
      into the thoracic paravertebral space where lateral and anterior cutaneous branches from Th7
      to L1 can be blocked . This was proved by Carney et al. who found traces of contrast agent in
      the TPVS following application of this block A novel USG QL block is the transmuscular
      approach which relies on clearly identifiable sonographic bony landmarks, Where the needle is
      advanced through the QL muscle, penetrating the ventral proper fascia of the QL muscle and LA
      is finally injected between the QL and Psoas major (PM) muscle. The transmuscular QL block
      does not result in redundant antero-lateral spread of the injectate. This may indicate that
      lower volumes of LA potentially can be used and yet provide extensive thoracolumbar
      anesthesia.

      This study was designed to compare the duration of analgesia provided by the original QLB and
      transmuscular QLB in patients undergoing surgical repair of unilateral inguinal hernia.
    


Intervention name(s): ultrasound guided quadratus lumborum block
Intervention type(s): Other
Intervention description(s): ultrasound guided quadratus lumborum block for post operative pain control after unilateral inguinal hernia repair.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
IGF-I and Free Fatty Acids Isn Glucose Metabolism in Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Observational

Summary: 
      Background Glucose metabolism abnormalities are frequent in acromegaly. Insulin resistance
      (IR) correlates with the intensity of acromegaly and Insulin-like Growth factor-I (IGF-I)
      correlates better with IR than growth hormone (GH). Insulin secretion (IS) is significantly
      reduced in hyperglycemic acromegalics as compared with those with normal glucose levels. IS
      is independent of acromegaly intensity.

      The aim of this study is to show that in active acromegaly: 1) IGF-I does not cause IR but is
      just a better marker of acromegaly intensity than GH; 2) high GH levels induce IR through
      free fatty acids (FFA); 3) hyperglycemia is caused by a defficient IS on a background of IR.

      Methods Intensity of acromegaly will be assessed using serum levels of GH, IGF-I and IGF
      binding globulin-3. IR and IS will be assessd using an intravenous glucose tolerance test
      acording to Bergman model. FFA will be directly measured in plasma.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will prospectively include patients with active acromegaly assessed in a tertiary
        center. All patients who meet inclusion and exclusion criteria will be invited
        consecutively to participate in the study until the proposed number of patients is reached.
Role of Oxygen for Vascular Dysfunction
Condition: Endothelial Dysfunction; FMD; IMT; Microcirculation; Oxygen Pressure; Carbon Dioxide Pressure; Oxygen Saturation; Forced Expiratory Volume After 1 Second
Study type: Observational

Summary: 
      Hypoxemia may contribute increased morbidity and mortality in chronic obstructive pulmonary
      disease (COPD) patients. We aim to characterize the role of acute and chronic hypoxemia for
      vascular function. For this purpose we measure capillary oxygen concentration and vascular.

      Vascular function is assessed by flow-mediated dilation oft he brachial artery, forearm blood
      flow and laser doppler perfusion imaging.

      We hypothesize that hypoxemia leads to impaired vascular function.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        CAD patients with or without COPD; healthy volunteers
      
Keywords: chronic obstructive pulmonary disease; Coronary artery disease; Endothelial function
A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about the safety and side effects of
      tirzepatide in Chinese participants with type 2 diabetes mellitus. The study will also
      measure how much tirzepatide gets into the bloodstream and how long it takes the body to
      remove it. The study will last about six or eight months for each participant.
    


Intervention name(s): Tirzepatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY3298176
Intervention MeSH terms: Tirzepatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Radial Artery Function Following Trans-radial Cardiac Catheterisation
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Observational

Summary: 
      The investigators will study Radial artery injury and endothelial function following
      trans-radial cardiac catheterisation. Radial artery injury will be quantified pre- and post-
      angiography using Optical Coherence Tomography. The participants will also have radial
      endothelial function assessed using flow-mediated dilatation at baseline, 24 hours, one week,
      one month and three months post- angiography. Blood will be taken pre and 24 hours post
      angiography for characterisation of endothelial progenitor cell numbers and function. The
      hypothesis is that trans-radial catheterisation will cause a reduction in flow-mediated
      dilatation which peaks at 24 hours and recovers at three months. The investigators hope to
      correlate the rate of this recovery with peri-procedural progenitor cell numbers.
    


Intervention name(s): Coronary angiography
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Stable outpatient population attending for angiography
Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation
      (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.

      Identify whether there are clinically significant differences in the tolerability of MAP0004
      between smokers and non-smokers.
    


Intervention name(s): MAP0004; IV DHE
Intervention type(s): Drug; Drug
Intervention description(s): 1.0mg MAP0004 via inhalation at Visit 2 or 3 as per protocol; IV DHE administered at Visit 2 or 3 as per protocol
Other intervention name(s): D.H.E.45®
Intervention MeSH terms: Dihydroergotamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Plasma Betatrophin Levels in Non-alcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      The study searched for answers to two questions:

      1-What are the plasma betatrophin levels in subjects with non-alcoholic fatty liver disease
      and healthy controls.

      2. Is there any relationship between plasma betatropin levels and different stage of
      non-alcoholic fatty liver disease 2.Is there any relationship between plasma betatropin
      levels and metabolic parameters in subjects with non-alcoholic fatty liver disease.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Outpatient clinics of gastroenterology
      
Keywords: Non-alcoholic Fatty Liver Disease; Betatrophin
A Safety and Tolerability Study of Belumosudil (KD025) Treatment in Subjects With Moderately Severe Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to assess the safety and tolerability of 200 mg of belumosudil
      administered orally once daily for 28 days.
    

Detailed description: 
      This will be a Phase 2a, open-label, single-arm, safety and tolerability study of belumosudil
      given daily for treatment of psoriasis.

      Eight subjects with moderately severe psoriasis who have failed at least 1 line of systemic
      therapy will be enrolled.

      Treatment Period Eligible subjects who have failed at least 1 line of systemic therapy will
      be entered and treated for 4 weeks (28 days) with 200 mg of belumosudil given orally once
      daily (QD).

      Subjects will undergo medical history evaluations, physical examinations, vital sign
      measurements, weight, adverse event assessments, concomitant medication assessments, and
      laboratory testing including but not limited to blood sample collection for hematology and
      chemistry, urinalysis, coagulation, lipid panel, electrocardiogram, pregnancy test for
      females of childbearing potential, testing with the Psoriasis Area and Severity Index (PASI)
      scale and Physician Global Assessment (PGA) scale, and pharmacokinetic sampling.

      Follow-up Period:

      Visit will occur 4 weeks after the last dose of study drug in the Treatment Period of the
      study. This visit must be done within ± 3 days of the scheduled visit. The same assessments
      will be performed as in the Treatment Period.

      The duration of the study is 12 weeks: up to 4 weeks for screening, 4 weeks of treatment, and
      4 weeks of follow-up.
    

Intervention name(s): Belumosudil
Intervention type(s): Drug
Other intervention name(s): Rezurock (brand name); KD025; SLx-2119
Intervention MeSH terms: Belumosudil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment