bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Using Custom Photobiomodulation Therapy for the Treatment of Osteoarthritis of the Fingers and Rhizarthrosis
Condition: Osteoarthritis; Osteoarthritis Finger; Osteoarthritis Hand; Osteoarthritis Both Hands
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Osteoarthrosis (OA), a multifactorial degenerative process, is responsible for joint pain and
      functional limitation. In the hand, more specifically in the proximal and distal
      interphalangeal joints of the fingers, it is one of the sites of greatest manifestation of
      the disease. Numerous treatments, whether drug, rehabilitation or surgery, have been proposed
      with the aim of both interrupting the natural evolution of the disease and alleviating or
      stopping the symptoms. This study aims to evaluate the effectiveness of personalized
      Photobiomodulation Therapy (PBT) with regard to alleviating symptoms and improving the
      quality of life of these patients with the disease.
    


Intervention name(s): Photobiomodulation therapy (PBT); Sham Photobiomodulation therapy (Sham PBT)
Intervention type(s): Device; Device
Intervention description(s): Any invasive procedures will be done. The treatment in question will be done by a device that looks like a bracelet, which is placed on the hand/fingers to emit light/laser and does not cause pain or temperature change. There will be 8 photobiomodulation sessions, 2 per week, 10 minutes each session.
The dosimetric parameters of the therapy will be carried out in a standardized and personalized way, with programming of the light and all the necessary information so that the device can carry out the application of the treatment application of electromagnetic waves in the red and infrared spectral range 660-1000 nm).; Similar to active PBT, however, the device will not provide the active electromagnetic waves)
Other intervention name(s): Laser; Sham Laser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Physical Activity Program in End-state Liver Disease
Condition: End-stage Liver Disease (ESLD); Liver Transplant; Sarcopenia; Poor Physical Fitness; Cirrhosis; Portal Hypertension
MeSH terms: Liver Diseases; Hypertension, Portal; End Stage Liver Disease; Sarcopenia
Study type: Interventional

Summary: 
      The primary aim of this study is to improve both physical fitness and sarcopenia of patients
      with ESLD who are potentially eligible for liver transplantation through a 12-week physical
      training program. Secondary aims will focus on changes in anthropometrics, body composition,
      quality of life, and metabolic profile. This is a randomized clinical trial including 50
      patients, with half allocated to the active group (physical training program) and half to
      standard of care.
    


Intervention name(s): Nutritional consultation; Physical training program; Behavioral modification therapy
Intervention type(s): Other; Behavioral; Behavioral
Intervention description(s): Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids; Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.; The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Reduced factorial design study with 24 week randomized treatment of initial combination
      therapy with linagliptin and metformin in T2DM patients
    


Intervention name(s): linagliptin2.5mg/metformin1000mg; linagliptin2.5mg/metformin1000mg; linagliptin 5mg; Metformin 500mg; linagliptin2.5mg/metformin500mg; linagliptin2.5mg/metformin500mg; linagliptin 5mg; Metformin 1000mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): linagliptin2.5mg/metformin1000mg BID; linagliptin2.5mg/metformin1000mg BID; linagliptin 5mg once daily; Metformin 500mg BID; linagliptin2.5mg/metformin500mg BID; linagliptin2.5mg/metformin500mg BID; linagliptin 5mg once daily; Metformin 1000mg BID
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Post-placental Intrauterine Device Insertion During Cesarean Section
Condition: Intrauterine Device Migration
MeSH terms: Intrauterine Device Migration
Study type: Interventional

Summary: 
      Effective, reversible postpartum contraception decreases the chance of rapid repeat pregnancy
      and poor perinatal outcome in a subsequent pregnancy especially in women delivered by
      cesarean section.The traditional 6-week postpartum visits not evidenced based and may not
      meet patient needs, particularly with respect to provision of contraception.Intrauterine
      device placement after delivery of the placenta is an appealing strategy for increasing
      access to postpartum Intrauterine device because it does not require a separate postpartum
      visit.

      Advantage of post-placental Intrauterine device insertion, Intrauterine devices are
      recommended as first-line contraceptives by the American Academy of Pediatricians. The
      Centers for Disease Control and Prevention united state . Medical Eligibility Criteria for
      Contraceptive Use places no restrictions on use, and states advantages generally outweigh the
      risks for immediate postpartum use of Intrauterine devices.
    


Intervention name(s): Intrauterine device insertion; Cesarean section; Suture
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Post-placental insertion of intrauterine device during Cesarean section; to delivery of the fetus; to fix the intrauterine device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy Subjects
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Overweight; Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America. The aim of the trial is to
      investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the
      body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but
      otherwise healthy subjects.
    


Intervention name(s): NNC0165-1562; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) single dose [SD] or multiple dose [MD] with daily dosing.; Administered subcutaneously (s.c., under the skin) single dose [SD]) or multiple dose [MD] with daily dosing.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Standardization of 6 Minute Walk Test
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      The 6 minute walk (6MW) gives information about the exercise capacity and it is an important
      tool for clinical decisions and for the prognostic evaluation of PH patients. The test is
      technically simple to perform, inexpensive and reproducible. During the 6MW O2 saturation,
      heart rate, walking distance (in this study after every minute) and the level of dyspnea
      (BORG-dyspnea scale) may be recorded; however, at present, mainly the walking distance is
      evaluated. The test is sometimes criticized, because of the dependence on the patient's
      motivation.

      The purpose of the present study is to standardize the test by the incorporation of objective
      factors. The investigators are correlating the change of heart rate and dyspnea (BORG scale)
      with the achieved walking distance during subsequent examinations performed with different
      effort.
    

Detailed description: 
      On two different days the patients have to absolve four 6MW on different levels of effort -
      on both days a traditional test will be performed and additionally a test with more effort or
      with less effort. The order of the tests will be randomized. These two days of the
      examinations should be within a maximum of three months, provided that there is no sign of
      relevant clinical changes. After every minute the walking distance is determined. Heart rate
      and the O2 saturation are measured by pulsoxymetry during the whole test. Every two minutes
      the patients are asked about their dyspnea (Borg scale).

      The purpose of the present study is to standardize the test by the incorporation of objective
      factors and to detect the correlation between the walking distance and the level of effort
      during exercise. The investigators expect that the reliability and objectivity of 6MW may
      increase by the standardization.

      The additionally performed cardiopulmonary exercise testing helps to evaluate and stratify
      patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with pulmonary hypertension or exercise-induced pulmonary hypertension assessed by
        right heart catheterisation
      
Keywords: six minute walk
Open Label Study Investigating Safety and Efficacy of NPL2009 50 mg - 150 mg on Prepulse Inhibition Tests and Continuous Performance Tasks, Adults With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open label exploratory study to investigate the safety and effects of a single
      dose of NPL-2009(50 mg - 150 mg) on Prepulse Inhibition (PPI) Tests and Continuous
      Performance Tasks (CPT) in adults with Fragile X Syndrome
    


Intervention name(s): NPL-2009
Intervention type(s): Drug
Intervention description(s): Single doses of either 50mg, 100 mg or 150 mg NPL-2009
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; Tolerability
To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets under Fasting
      Conditions.
    


Intervention name(s): Bupropion HCl 100 mg Tablets (Invamed Inc.); Wellbutrin 100 mg Tablets (Glaxo Wellcome)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antidepressant
Effects of Sugar-free Products With Added Sweeteners on Glycemic Responses
Condition: Potential Abnormality of Glucose Tolerance; Appetitive Behavior
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      This study investigated the effects of three commonly used sugar-free snacks with added
      sweeteners on glycemic responses
    

Detailed description: 
      This study aimed at 1. to determine the glycemic index and glycemic load of three sugar-free
      products with added sweeteners: apricot jam, cranberry cereal bar, and cocoa drink, and 2. to
      investigate the effects of these products on the postprandial glycemic response in healthy
      subjects
    

Intervention name(s): Glucose as reference food; White bread as reference food; White bread with apricot jam; Cereal bar with cranberries; Cocoa drink
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.; Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.; Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread together with apricot jam along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.; Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from a cereal bar with cranberries along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.; Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from cocoa powder mixed with 500ml fat-free milk, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: blood glucose; glycemic index; cereal bar; jam; cocoa
Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this crossover trial is to compare the 3-month, mean 24-hour
      intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in
      glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will
      compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium
      chloride given once in the evening, versus the latanoprost/timolol fixed combination given in
      the evening. It is assumed that travoprost/timolol fixed combination will provide better
      quality of 24-hour pressure control.
    


Intervention name(s): Travoprost/timolol therapy; Latanoprost/Timolol therapy
Intervention type(s): Drug; Drug
Intervention description(s): Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing; Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy
Other intervention name(s): DuoTrav BAK Free; Xalacom
Intervention MeSH terms: Timolol; Travoprost; Latanoprost
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: glaucoma; fixed combinations; 24-hour monitoring
Evaluation of Sarcopenia in Patients With Stroke
Condition: Sarcopenia; Stroke
MeSH terms: Stroke; Sarcopenia
Study type: Observational

Summary: 
      The aim of this study is to investigate the prevalence of sarcopenia in stroke patients; to
      determine the relationship between sarcopenia and duration of stroke, age, gender, etiology
      of stroke, ambulation status, spasticity, nutrition and malnutrition
    

Detailed description: 
      Sarcopenia was defined as a loss of skeletal muscle mass and decreased muscle strength. The
      purpose of this study was to investigate the prevalence of sarcopenia following stroke, to
      investigate the relationship between sarcopenia and duration of stroke, age, sex, etiology of
      stroke, ambulation status, spasticity, nutrition and malnutrition. Demographic
      characteristics, duration of stroke, sarcopenia presence (walking speed ≥ 0.8 m / s, SARC-F
      score ≥4, short physical performance battery score ≤ 8, thigh circumference <33cm (The data
      for Turkey) <31cm (European data)) were recorded. Hand grip strength (jamar) measured from
      the intact hand and TANITA BIA analysis were planned for all patients.

      Ambulation level with Functional Ambulation Classification (FAC), nutritional status with
      24-hour dietary recall (24HR) method, diagnosis of malnutrition with Glim Criteria,
      spasticity with Modified Ashworth Scale, motor development for stroke patient Brunnstrom
      staging, screening for frailty with Frail questionnaire activity of daily living were
      evaluated with Barthel Index.
    

Intervention name(s): SARCOPENIA IN STROKE PATIENTS
Intervention type(s): Other
Intervention description(s): Demographic characteristics, duration of stroke, sarcopenia presence,thigh circumference , Hand grip strength , TANITA BIA analysis
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Inpatient stroke cases
      
Keywords: sarcopenia; stroke
Prolonged Laryngeal Mask Airway ProSealTM Use
Condition: Airway Management
Study type: Observational

Summary: 
      The investigators conclude that use of the LMA ProSealTM for prolonged procedures is
      feasible. In principle, it should be safer and more effective than the LMA ClassicTM provided
      basic guidelines are followed.
    

Detailed description: 
      There is controversy concerning use of the classic laryngeal mask airway (LMA ClassicTM) for
      prolonged procedures, particularly over 2 hours, as some clinicians consider it unsuitable
      for positive pressure ventilation (needed to counter the alleged progressive respiratory
      fatigue with time) and/or unsuitable for airway protection (needed to counter the alleged
      progressive increase in aspiration risk with time). The LMA ProSealTM is a laryngeal mask
      device with a modified cuff to facilitate ventilation and a drain tube to provide airway
      protection. In principle, the LMA ProSealTM should be more suitable than the LMA ClassicTM
      for prolonged procedures; however, there are only four reports and one case series.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We describe the use of the LMA ProSealTM in seven patients in a variety of clinical
        situations for procedures lasting more than 5 hours.
Cognitive Effects of Mint Essential Oil
Condition: Cognitive Change; Affect
Study type: Interventional

Summary: 
      This study investigates the cognitive and mood effects of mint essential oils in a group of
      healthy, human adults. The investigational product will also be tested in vitro to ensure a
      number of biological mechanisms.
    

Detailed description: 
      The volatile components of essential oils (e.g. sage, lemon balm and rosemary)are found to
      exert a number of psychotropic effects and the monoterpenes in particular seem to be
      responsible for the cognitive and mood effects attributed to them.

      The current study aims to investigate the cognitive and mood effects of mint essential oil in
      humans and to ensure the efficacy of the investigational product by conducting in vitro
      analysis on central nervous system receptor binding properties.

      This will be achieved by analysing gamma-Aminobutyric acid A (GABAA), neuronal nicotinic and
      N-methyl-D-aspartate receptor (NMDA) glutamate receptor binding efficacy,
      acetylcholinesterase (AChE) inhibition, and gas chromatography-mass spectrometry (GC-MS)
      analysis will quantify % Limonene, % Carvone, % Menthone and % Menthol levels in the
      investigational treatment.

      Cognitive and mood assessment will be via a randomised, placebo controlled, crossover design
      in 24, healthy adults aged between 18-35 yrs which will involve x1 training and x3 testing
      visits to the lab (placebo, 50 (micro Litre) μL and 100 μL Mentha piperita essential oil).
    

Intervention name(s): Mentha piperita; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Commercially available essential oil suspended in an off-the-shelf vegetable oil.; Inert placebo control in the form of vegetable oil. This matches the vegetable oil in the active intervention condition.
Other intervention name(s): Peppermint
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised, placebo controlled, crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Mentha; Mint; Essential oil; Cognition; Mood; Humans
MRD-directed Therapy for Low-risk and Intermediate-risk AML.
Condition: Acute Myeloid Leukemia; Minimal Residual Disease
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neoplasm, Residual
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Acute myeloid leukemia(AML) patients with favorable and intermediate cytogenetics at
      diagnosis are generally excluded from first-line allo-SCT. However, these patients may
      eventually relapse in some cases. Our previous study found that stratification of treatment
      based on cytogenetics and therapeutic response could benefit low and intermediate AML. To
      further verify the results, we conducted a prospective multi-center study. The purpose of
      this study is to establish risk stratification based on cytogenetics and
      minimal-residual-disease (MRD) analysis to determine whether a MRD-directed therapy for low
      and intermediate AML patients has positive results in terms of overall survival.
    


Intervention name(s): MRD-directed therapy
Intervention type(s): Combination Product
Intervention description(s): The purpose of this study is to establish risk stratification based on cytogenetics at diagnosis and MRD analysis after induction chemotherapy and before consolidation chemotherapy to determine whether a MRD directed therapy for low and intermediate AML patients has positive results in terms of overall survival.
Intervention model: Single Group Assignment
Intervention model description: MRD-directed therapy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MRD; Acute myeloid leukemia