bioihbjkbjnl/mcl2 huggingface dataset:
Effects of L-theanine and Caffeine on Attention and Attention-related Brain Activity of Children With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      L-theanine and caffeine are two natural constituents of tea. Both of these compounds are
      among the U.S. Food and Drug Administration's list of Generally Recognized as Safe (GRAS)
      substances. Results of several clinical trials the PI and his team has conducted are
      consistent with results of many others to indicate that oral intake of each of 2.5 mg/kg body
      weight of L-theanine and 2.0 mg/kg body weight of caffeine is associated with improved
      attention in adults. Furthermore, there is evidence to suggest that, when taken in
      combination, L-theanine and caffeine seem to have additive effects in improving attention in
      adults. However, the specific actions of these substances have not been examined in children
      and adolescents with attention deficit hyperactivity disorder (ADHD), who are characterized
      by impaired attention, hyperkinesia and impulsivity.

      Therefore, the investigators plan to study the functional activity of brains (both at rest
      and when performing standard tasks designed to measure attention) in children diagnosed with
      ADHD using functional magnetic resonance imaging, after they consume either 2.5 mg/kg of
      L-theanine, 2.0 mg/kg of caffeine and their combination as compared to a placebo (water).
      Based on our previous findings, the investigators expect to observe improvements (speed of
      responding and accuracy) in standard tests of attention with intake of L-theanine, caffeine
      and their combination as compared to the placebo. The investigators also expect to observe
      decreased functional activity in brain regions that typically show increased activity during
      mind wandering with intake of L-theanine, caffeine and their combination.
    


Intervention name(s): L-theanine; Caffeine; L-theanine-Caffeine Combination; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Oral administration of 2.5 mg/kg body weight of L-theanine dissolved in 100 ml of water; Oral administration of 2.0 mg/kg body weight of caffeine dissolved in 100 ml of water; Oral administration of a combination of 2.5 mg/kg body weight of L-theanine and 2.0 mg/kg body weight of caffeine dissolved in 100 ml of water; Oral administration of 100 ml of water
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2.5 mg/kg body weight of L-theanine, 2.0 mg/kg body weight of caffeine and their combination each dissolved in 100 ml of water (solvent) or the solvent alone (i.e. placebo) will be administered on 4 separate days (at least 5 days apart) in a random counter-balanced order.
Masking: Single (Participant)
Primary purpose: Treatment
Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer
Condition: Lung Cancer; Biomarkers; Fatty Acids
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      This study aims to evaluate the performance of serum free fatty acids as biomarkers for the
      identification of lung cancer.
    

Detailed description: 
      We will compare the concentration of free fatty acids and their metabolites between patients
      with lung cancer and control pulmonary patients without known cancer. The diagnostic accuracy
      will be assessed for potential predictors.
    

Intervention name(s): serum sample
Intervention type(s): Other
Intervention description(s): Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patient samples are retrieved from the Cleveland Clinic Biobank.
      
Biospecimen description: 
      Blood will be sampled for FFA metabolites
A Study of MORAb-003 in Patients With Solid Tumor
Condition: Neoplasms; Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      MORAb-003 is intravenously administered to Japanese patients with folate receptor-alpha
      expressing solid tumor once a week for 4 weeks as 1 cycle in order to investigate
      dose-limiting toxicity and estimate maximum tolerated dose.
    


Intervention name(s): MORAb-003
Intervention type(s): Drug
Intervention description(s): MORAb-003 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose
Intervention MeSH terms: Farletuzumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; FRα
Effect of Metabolic Syndrome on Complex Decongestive Physiotherapy Outcomes in Lymphedema Patients
Condition: Lymphedema
MeSH terms: Lymphedema; Metabolic Syndrome
Study type: Observational

Summary: 
      As a result of our research, investigators could not find any study investigating the
      effectiveness of complex decongestive physiotherapy (KBF) in lymphedema patients with
      metabolic syndrome. Therefore, our aim is to compare the effectiveness of KBF in patients
      with and without metabolic syndrome.
    

Detailed description: 
      This study was planned to investigate the effects of metabolic syndrome seen in patients with
      lymphedema on the results of complex decongestive physiotherapy. Lymphedema is a chronic
      disease characterized by the accumulation of protein-rich fluid in the interstitial space.
      Among all the treatment approaches known in the field, Complex Decongestive Physiotherapy
      (CDT) is accepted as the gold standard in the treatment of lymphedema. CDT is a treatment
      approach consisting of manual lymph drainage, skin care, compression bandage and exercises.
      In clinical studies conducted to date, the effectiveness of CDFT in the treatment of lower
      and upper extremity lymphedema has been clearly demonstrated.

      Metabolic syndrome is a medical term that describes the combination of various cardiovascular
      risk factors such as insulin resistance, impaired glucose tolerance or diabetes mellitus,
      obesity, abdominal fat accumulation, dyslipidemia, hypertension, and coronary artery disease.
      Obesity, the cardinal component of the metabolic syndrome, is a well-known risk factor for
      lymphedema, and increased body mass index (BMI) is associated with the frequency and severity
      of lymphedema. Obesity often accompanies lymphedema due to the effect of lymphedema and the
      characteristics of patients with lymphedema.

      Our aim in this study, which was planned in the light of these data, is to examine whether
      the presence of metabolic syndrome in patients with lymphedema changes the effectiveness of
      CDT.
    

Intervention name(s): Complex decongestive physiotherapy
Intervention type(s): Other
Intervention description(s): CDT is a treatment approach consisting of manual lymph drainage, skin care, compression bandage and exercises.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        As a result of the power analysis made with the help of the preliminary study data using
        the G*Power 3.0.10 program; with 90% power, 5% margin of error and f=0.27 effect size, a
        total of at least 40 samples were found to be sufficient (metabolic syndrome group: 20;
        control group: 20).

        Patients diagnosed with lymphedema by a specialist in our clinic will be divided into 2
        groups as those with metabolic syndrome and those without metabolic syndrome.
      
Keywords: lymphedema; metabolic syndrome
Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat
Condition: Moderate or Severe Submental Fullness
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of
      submental fat (fat below the chin).
    


Intervention name(s): Deoxycholic acid injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Phosphate buffered saline placebo for injection
Other intervention name(s): ATX-101
Intervention MeSH terms: Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Post Infarction Exercise Effects on Myocardial Function Assessed by 2D Strain Ultrasound
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The main goal of our project is to study and describe the effect of exercise training on
      systolic and diastolic myocardial function assessed by 2D ultrasound strain after myocardial
      infarction.

      Our working hypothesis is that the intrinsic myocardial contractility and relaxation assessed
      by global longitudinal strain in phase II (or 2D strain) during post-infarction exercise
      training will be improved compared to baseline values as well as compared to values in a
      no-training group. Should this hypothesis prove true, it would help explain the improvements
      in functional capacity observed during the post-infarction period and after exercise
      training.
    


Intervention name(s): Cardiac training program
Intervention type(s): Other
Intervention description(s): This program takes place at the Cardiovascular Rehabilitation Department at the Nîmes University Hospital and includes a combination of various physical activities: treadmill, exercise bike, rower, aerobics, gymnastics, serious games, swimming. The program begins approximately within 3 months after myocardial infarction and consists of 20 consecutive days of training. The main physical activity is aerobic interval training (AIT).
30-minute AIT sessions will occur 5x per week for 4 weeks.
1 AIT session includes a warm up for 8 minutes to reach a heart rate during exercise corresponding to 20 to 30% of maximum aerobic power determined during the initial effort test. Then interval training occurs with 4x2 min of high intensity effort (heart rate during exercise corresponding to 80% of maximum aerobic power) alternating with 2 min of active recovery at 20-30% of maximum aerobic power. Then recovery for 8 minutes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Orally Administered ZM-H1505R to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Doses in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      ZM-H1505R is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the
      treatment of Chronic Hepatitis B.

      The purpose of this study is to see how safe the study drug is and how well it is tolerated
      after dosing. The study will also test how the study drug is taken up and eliminated by the
      body. An additional part of the study is to look at how this could be changed by giving the
      study drug with food.
    


Intervention name(s): ZM-H1505R
Intervention type(s): Drug
Intervention description(s): Single oral doses of 300, 450, 600, 750, and 900 mg of ZM-H1505R or placebo and multiple oral doses of 450, 600, and 750 mg of ZM-H1505R or placebo will be administered in a fasted state, or in the case of Cohort 3 (Part 1), a second dose of 600 mg will be administered in the fed state. During each SAD and MAD dosing period, 2 subjects in each cohort will receive placebo instead of ZM-H1505R. The dose levels may be adjusted based on the safety and tolerability obtained from the previous cohort.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study to Investigate the Impact of Dose and Dosing Frequency of AZD8848 on the Response on Biomarkers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will investigate how the dose of AZD8848 and the dosing frequency will affect the
      immunological/inflammatory response by measuring the production of biomarkers in blood and
      nasal lavage.
    


Intervention name(s): AZD8848; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The subjects are dosed with a range of intranasal doses of AZD8848 on 2, 3, 4 or 7 days of the 7 days treatment period. On the other days the subjects receive placebo.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Intranasal; Biomarker; Healthy; Effect of different doses and dosing regimens of AZD8848 on biomarkers; Effect different doses and dosing frequency of AZD8848 on biomarkers
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment
Condition: Moderate Liver Impairment; Severe Liver Impairment
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of impaired liver function on the drug
      levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver
      impairment. Results from this study will be used to determine whether dose adjustment is
      required for patients with decreased liver function.
    


Intervention name(s): BMS-986036
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cirrhosis; Hepatic impairment; Liver impairment; Nonalcoholic steatohepatitis (NASH)
Delayed Cord Clamping in Infants Born by Cesarean Section
Condition: Umbilical Cord Management; Elective Cesarean Section
Study type: Interventional

Summary: 
      Introduction: Placental transfusion supports an important blood transfer to the neonate,
      promoting a more stable and smooth transition from fetal to extra-uterine life. Cesarean
      section, especially elective one, reduces the placental transfusion, mainly because of
      uterine atony. Therefore, during an elective cesarean section umbilical cord management may
      play a relevant role on blood passage to the neonate and, as consequence, it may affect
      neonatal hematological values and cardiovascular parameters. The most effective way to manage
      umbilical cord in in elective cesarean section remains to be established.

      Objective: The aim of the present study is to evaluate the effect of two different methods of
      umbilical cord management (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the
      hematocrit on the second day of life; in addition, we will assess the effect on perinatal and
      postnatal cardiovascular parameters.

      Material and methods: This is a randomized clinical trial on the effect of different cord
      management newborns born by cesarean sections. After obtaining parental consent, all mothers
      > 38 weeks' gestation will be assigned to eithr ECC or DCC group in a 1:1 ratio according to
      a computer-generated randomized sequence. The primary outcome will be the hematocrit on day 2
      of life. Secondary outcomes will be pre-ductal oxygen saturation (SaO2) and the heart rate
      (HR) during the first ten minutes after the birth, arterial blood pressures during the first
      3 postnatal days and transcutaneous bilirubin (BT) at day 3 after birth.
    


Intervention name(s): Delayed cord clamping; Early cord clamping
Intervention type(s): Procedure; Procedure
Intervention description(s): Cord clamping will be performed after 60 seconds of life in infants delivered by cesarean section; Cord clamping will be performed within 10 seconds of life in infants delivered by cesarean section
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early cord Clamping; Delayed cord clamping; Full term infant; Elective cesarean section; Hematocrit; Postnatal adaptation
Ketogenic Diet for Obesity Hypoventilation Syndrome
Condition: Obesity Hypoventilation Syndrome; Ketogenic Dieting; Hypercapnic Respiratory Failure
MeSH terms: Respiratory Insufficiency; Hypoventilation; Obesity Hypoventilation Syndrome; Obesity; Syndrome
Study type: Interventional

Summary: 
      Obesity hypoventilation syndrome (OHS) is a condition that occurs in small percentage of
      obese people that causes high carbon dioxide and low oxygen levels in the blood. OHS is
      associated with respiratory failure, pulmonary hypertension, and death. The cause of OHS is
      unclear. Since not all obese people develop OHS, it is believed that hormone imbalances can
      contribute to the breathing problem.

      Some diets can change the body's hormones. For example, low-carbohydrate, high fat
      "ketogenic" diets (KD) may decrease insulin and glucose levels and increase sensitivity to
      other hormones. The investigators hypothesize that a KD will improve breathing in OHS
      patients, even in the absence of weight loss.
    

Detailed description: 
      Obesity hypoventilation syndrome (OHS) is a condition that occurs in small percentage of
      obese people, that leads to high carbon dioxide levels and low oxygen levels in the blood.
      OHS is associated with respiratory failure, pulmonary hypertension, hospital admissions, and
      death. Unfortunately, there is no treatment for OHS besides massive weight loss which often
      requires bariatric surgery.

      In this study, the investigators are examining whether switching from a regular diet to a
      ketogenic diet will improve breathing, oxygen, and carbon dioxide levels in OHS patients.
      After a few days-weeks on KD, hormone changes are known to occur and the investigators are
      examining whether these hormonal changes could stimulate breathing.

      This is a pilot study to examine the effects of a 12 day KD on OHS. The outcomes of the study
      include blood oxygen, carbon dioxide levels, plasma levels of hormones such as insulin,
      leptin, sleep studies, body composition a, weight, and metabolic rate.
    

Intervention name(s): Ketogenic Diet
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will undergo ketogenic diet at a 2.5:1 (fat: carb + protein) ratio for a 2-week period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cervical Spine Strengthening Exercises Versus Kendall Exercises in Patients With Forward Head Posture.
Condition: Forward Head Posture
Study type: Interventional

Summary: 
      To compare the effects of targeted cervical spine strengthening exercises and Kendall
      exercise in patients with forward head posture
    

Detailed description: 
      Studies have evaluated the effect of Kendall's exercises and found it effective for recovery.
      Studies have also concluded that targeted strengthening of flexors reverse the symptoms. The
      purpose of this study will elaborate either there is a difference in time taken to achieve
      normal head alignment between a targeted muscle that is prone to weakness or a technique that
      involves strengthening of weakened muscle plus stretching of shortened muscles. As there is a
      vast variety of correcting exercise program in the literature, the decision to choose the
      best option may be challenging. This study may help physiotherapists to apply treatment that
      is directly directing the main culprit.
    

Intervention name(s): kendall's exercise; cervical spine strengthening
Intervention type(s): Other; Other
Intervention description(s): comparative effect of targeted cervical spine strengthening versus kendalls exercise will be analyzed; sole effect of cervical spine strengthening will be analyzed
Other intervention name(s): cervical spine strengthening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Forward head, Kendall exercises.
The Effects of Glucomannan on Weight Loss
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if the herb, Glucomannan, is an effective
      non-pharmacological appetite suppressant for overweight or Class I obese patients. The study
      design will not include any other lifestyle changes which enhance weight loss in order to
      completely isolate the effects of Glucomannan as a non-pharmacological appetite suppressant.
    


Intervention name(s): Glucomannan; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 750 MG of Glucomannan in capsule form; 750 mg of Cellulose powder in a capsule form
Intervention MeSH terms: (1-6)-alpha-glucomannan
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Glucomannan
Interaction of Epanova on Warfarin Pharmacokinetic and Anticoagulant Activity and Comparison of the Effects of Epanova and Lovaza on Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) After Low-fat Meals
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the effect of Epanova® on the
      pharmacokinetic and anticoagulant activity of warfarin.

      The secondary objective of this study is to compare the systemic exposure of EPA and DHA
      following multiple-dose administration of Epanova®, a free fatty acid mixture, to Lovaza®, a
      mixture of fatty acid ethyl esters, under low-fat meal conditions since these products are
      likely to be administered to patients with cardiovascular disease who are recommended to
      consume low-fat meals.
    


Intervention name(s): warfarin; omefas; omega-3-acid ethyl esters
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single 25 mg dose of warfarin; 4 x 1 g capsule dose of Epanova®; 4 x 1 g capsule dose of Lovaza®
Other intervention name(s): coumarin-based anticoagulant; Epanova; Lovaza
Intervention MeSH terms: Warfarin; Anticoagulants
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eicosapentaenoic Acid; Docosahexaenoic Acid; Warfarin; Hypertriglyceridemia; Omega-3 free fatty acids; Omega-3 ethyl ester acids; Epanova; Lovaza; pharmacokinetics; low-fat meal