bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      PURPOSE:

      To evaluate the feasibility of a future Nordic intervention trial, including vigorous
      activity and a high intake of whole grain rye, among prostate cancer patients on active
      surveillance.

      Additionally, to investigate effects of the lifestyle intervention according to cancer
      progression, the metabolic profile, inflammation and quality of life among prostate cancer
      patients on active surveillance.
    

Detailed description: 
      In the present feasibility study it will be established whether it is possible to enroll
      participants for this particular kind of intervention among this particular patient group,
      and if compliance with the intervention is possible to gain by the tools planned: individual
      counselling with a dietician and a physiologist, interviews on diet, exercise tests and
      diaries on diet, exercise and steps taken.

      Furthermore, the investigators will investigate if we are able to detect effects of the
      lifestyle intervention according to cancer progression, the metabolic profile, inflammation
      and quality of life among the participants (24 men) within the short intervention period (6
      months) for this particular feasibility study.

      Biomarkers of effect and compliance are measured in blood, urine and prostate tissue samples.
      Metabolomics and the following biomarkers are measured in blood and urine samples: Alkyl
      resorcinols, enterolactone, tnf receptor 2, e-selectin. ICAM1, IL1-alpha, IL6, triglycerides,
      HDL/LDL, s-insulin, HbA1c, C-peptide, CRP, IGF1, GLP1, cholesterol, cathepsin and glucose.
    

Intervention name(s): Exercise; Whole grain rye; Recommendations
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Prescriptions: Vigorous exercise (average 65-70% of maximal oxygen consumption) minimum 3 times 45 minutes per week according to customized endurance training programs.
Restrictions: None.; Prescriptions: Minimum 170-180g of whole grain rye intake per day. Restrictions: None.; Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate cancer progression; active surveillance; whole grain rye; exercise; insulin sensitivity; quality of life
A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the single-dose pharmacokinetic (PK) of JNJ-73763976
      and JNJ-73763924 following a subcutaneous (SC) injection of JNJ-73763989 (JNJ-3989) in
      participants with liver cirrhosis and various degrees of impaired hepatic function when
      compared with healthy participants with normal hepatic function and no liver cirrhosis.
    


Intervention name(s): JNJ-73763989
Intervention type(s): Drug
Intervention description(s): JNJ-73763989 will be administered SC under fasted condition.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, and Pharcodynamics of AMG 853 in Adolescents With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study the safety and tolerability in adolescent and adult
      subjects with intermittent or mild to moderate persistent asthma.
    


Intervention name(s): AMG 853; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose administration of AMG 853 or placebo in tablet form to adolescent and adult subjects with asthma; Placebo to AMG 853
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Amgen; Adolescent; Safety
Effect of Salmeterol on Fluid Clearance From Alveolar-Capillary Membrane in COPD Patients
Condition: Salmeterol Effect Against an Acute Alveolar Fluid Clearance Challenge Secondary to Lung Fluid Overload in COPD Patients; Chronic Obstructive Pulmonary Disease; Bronchodilator Agents; Salmeterol
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The cardiovascular component associated with COPD plays a major role in prognosis of the
      disease, being responsible of 25% of the deaths. Experimental and initial clinical data
      suggest that beta-adrenergic agonists accelerate clearance of excess fluid from the alveolar
      airspace, with potential positive effect on cardiogenic pulmonary edema.

      The aim of this study was to investigate the effects of a long-acting beta-2 agonist,
      salmeterol, on alveolar fluid clearance in COPD patients by evaluating the diffusive and
      mechanical lung properties. Our experimental model to test alveolar fluid clearance was rapid
      saline intravenous infusion.

      Ten COPD and 10 healthy subjects treated with salmeterol or placebo 4 hours before the begin
      of the study were evaluated, in four non consecutive days, just before and after a saline
      infusion or a similar period without infusion.

      Both in COPD and healthy subjects rapid saline infusion, with placebo or salmeterol
      premedication, lead to a significant decrease of DLCO and FEV1. Nonetheless, salmeterol
      pretreatment lead to a significant reduction of the impairment of gas exchange due to saline
      infusion (-64% of DLCO reduction in comparison with placebo), whilst it did not affect the
      changes in FEV1. In the control setting, with no infusion, we did not find any significant
      change of both DLCO and mechanical properties of the lung.

      In conclusions, in COPD patients salmeterol appears to provide a protective effect against an
      acute alveolar fluid clereance challenge secondary to lung fluid overload providing an
      intriguing mechanistic explanation for the benefits observed in larger trials.
    


Intervention name(s): Salmeterol; saline infusion (0.9 per cent sodium chloride); Placebo
Intervention type(s): Drug; Procedure; Other
Intervention description(s): 50 mcg MDI (inhalatory), once on days A and C at t=0,; rapid 50-minute 750-ml 0.9% saline infusion 240 minutes after inhalatory treatment on day A and B; placebo, inhalatory (MDI) once
Other intervention name(s): long acting bronchodilator agents; physiologic saline solution
Intervention MeSH terms: Salmeterol Xinafoate; Bronchodilator Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: COPD; LABA; salmeterol
Cranberry Consumption Improves γδ T Cell Function
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the extent to which consuming a cranberry beverage
      modifies immune function, specifically related to γδ T cells and other innate immune cells.
      It is hypothesized that cranberry components will interact with immune cells to activate
      signaling pathways that enhance cell function. Enhanced immune cell function should result in
      reduced number, duration, and severity of cold and flu symptoms.
    


Intervention name(s): Cranberry Beverage; Placebo Beverage
Intervention type(s): Other; Other
Intervention description(s): 8 oz cranberry beverage consumed daily for 12 weeks; 8 oz placebo beverage consumed daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cranberry; gamma delta T cell; improvement in immune cell function in healthy humans; proliferation
A Study to Assess the Amount of LY3074828 That Gets Into the Body When Given With LY9999QS, in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at the amount of the study drug, LY3074828, that gets
      into the blood stream and how long it takes the body to get rid of LY3074828 when given
      together with LY9999QS compared to LY3074828 alone. The tolerability of the different
      formulations will also be evaluated and information about any side effects experienced will
      be collected.

      Screening is required within 28 days prior to the start of the study. For each participant
      the total duration of the clinical trial will be approximately 13 weeks, not including
      screening.
    


Intervention name(s): LY3074828; LY900021
Intervention type(s): Biological; Biological
Intervention description(s): Administered IV; Administered SC
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatments 2 and 3 of LY900021 will be administered in parallel with LY3074828. Treatments 2, 3, and 4 of LY900021 will be administered sequentially pending a safety review after administration of Treatments 2 and 3.
Masking: None (Open Label)
Primary purpose: Basic Science
TELEMS: Feasibility of Remote Patient Visits in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This trials randomizes patients with multiple sclerosis (MS, pwMS) to a remote visit (via
      phone or videochat) or a regular outpatient visit. Outcomes include satisfaction on the
      patients' and doctor's side.
    


Intervention name(s): EDSS; Discussion of symptoms, Patient reported outcome (MSIS)
Intervention type(s): Other; Other
Intervention description(s): Neurological Exam - EDSS (Expanded Disability Status Scale); Patients will be asked about their wellbeing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: multiple sclerosis; remote visits; telemedicine; remote patient monitoring; remote monitoring
Androgen Metabolism and Reproductive Outcome
Condition: Polycystic Ovary Syndrome; Healthy Pregnant Women
MeSH terms: Polycystic Ovary Syndrome
Study type: Observational

Summary: 
      The aim of this study is to determine maternal androgen metabolism during pregnancy and the
      impact of androgen disorders on mothers and infants.
    

Detailed description: 
      Women with polycystic ovary syndrome (PCOS) have an impaired fertility and significant higher
      complication rates during infertility treatment, pregnancy and the perinatal period.
      Complications include the occurrence of multiple gestations, ovarian hyper stimulation
      syndrome, early pregnancy loss, gestational diabetes, pregnancy-induced hypertension,
      pre-eclampsia and need for caesarean section. Moreover, their infants are more frequently
      born preterm, have higher perinatal mortality rates and are more often admitted to a neonatal
      intensive care unit. The etiology of PCOS is not particularly mapped, but a genetic
      background can be assumed by analyzing PCOS families. In utero androgen excess has also been
      suspected to be an important risk factor. Animal studies have demonstrated that intrauterine
      hyperandrogenic environment affects the offspring by leading to biochemical and morphological
      features of PCOS. Sex differences in prenatal androgen levels have been observed and
      testosterone levels in umbilical cord blood and in amniotic fluid are higher in healthy male
      babies than in healthy female babies. There are just a few reporting on the relation between
      maternal androgen levels during pregnancy and the respective offspring. The aim of this
      clinical study is to determine maternal androgen metabolism and the impact of androgen
      disorders on mothers and infants.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Polycystic ovary Syndrome (PCOS): According to ethnicity and the criteria used for
        diagnosis, polycystic ovary syndrome (PCOS) affects between 2-13% of women of reproductive
        age (Asunción et al., 2000; Azziz et al., 2009; ESHRE/ASRM, 2004; Wang and Alvero, 2013).
      
Keywords: polycystic ovary Syndrome; hyperandrogenism; cordblood; androgens
Study With Lu AF87908 in Healthy Participants and Participants With Alzheimer's Disease
Condition: Healthy; Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety of a single dose of Lu AF87908, how
      well it is tolerated and what the body does to the drug in healthy participants and
      participants with Alzheimer's disease.
    

Detailed description: 
      The study will be divided into three parts: Part A, Part B and Part C.

      Part A consists of up to 6 sequential cohorts (Cohorts A1 to A6):

      -Cohorts A1 to A6: 8 healthy participants per cohort (aiming for an equal number of men and
      women): 6 randomized to Lu AF87908 and 2 randomized to placebo.

      Part B consists of up to 3 sequential cohorts (Cohorts B1 to B3):

      -Cohorts B1 to B3: 4 Japanese and 4 Chinese healthy participants per cohort: 6 participants
      randomized to Lu AF87908 and 2 participants randomized to placebo.

      Part C consists of 2 sequential cohorts (Cohorts C1 and C4):

      -Cohort C1 will consist of 6 participants with Alzheimer's disease with 3:1 randomization
      scheme for active: placebo. Cohort C4 will consist of up to 8 participants. Cohort C4
      participants will be randomized based on the randomization scheme from Cohort C1.
    

Intervention name(s): Lu AF87908; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lu AF87908 concentrate for solution for intravenous (IV) infusion; Concentrate for solution for IV infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether SLx-4090 in combination with metformin
      therapy will reduce HbA1c in patients with Type 2 Diabetes more effectively than metformin
      therapy alone.
    

Detailed description: 
      1. HbA1c after 12 weeks

        2. FPG after 12 weeks

        3. Safety and tolerability

        4. Plasma levels of SLx-4090
    

Intervention name(s): SLx-4090; Placebo; Metformin
Intervention type(s): Drug; Other; Drug
Intervention description(s): SLx-4090; matching tablets
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics,
      Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904,
      HGP0608 and HCP1306 Tablets in Healthy Male Subjects
    


Intervention name(s): HCP1701; HCP1306; HGP0904; HGP0608
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium; Ezetimibe /Rosuvastatin; Amlodipine; Losartan potassium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017)
Condition: Insomnia; Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine whether the plasma concentration-time profile and pharmacokinetics
      (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are
      similar to those observed in healthy participants.
    

Detailed description: 
      Study Design:

      This study plans to enroll 16 participants in Part I (8 participants with moderate hepatic
      insufficiency and 8 healthy participants) and 16 participants in Part II (8 participants with
      mild hepatic insufficiency and 8 healthy participants).

      Part II will be conducted only if the primary hypothesis is not met and there is a
      significant difference in the PK of suvorexant between healthy participants and moderate
      hepatic insufficiency participants in Part I.
    

Intervention name(s): Suvorexant
Intervention type(s): Drug
Intervention description(s): single 20 mg dose of suvorexant will be administered as 2 x 10 mg film coated tablets on Day 1 after an overnight fast with water.
Other intervention name(s): MK-4305
Intervention MeSH terms: Suvorexant
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Insufficiency
SPYRAL DYSTAL Renal Denervation Global Clinical Study
Condition: Hypertension; Vascular Diseases; Cardiovascular Diseases
MeSH terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
Study type: Interventional

Summary: 
      The objective of this single arm interventional study is to determine if renal denervation
      performed in the distal main and first order branch renal arteries is as effective in
      reducing blood pressure as the procedural approach used in the SPYRAL HTN-OFF MED clinical
      study.
    


Intervention name(s): Renal Denervation (Symplicity Spyral™)
Intervention type(s): Device
Intervention description(s): Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Other intervention name(s): Renal Angiography; Renal Denervation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uncontrolled hypertension; Renal denervation
Comparison of Three Calcium Supplements
Condition: Healthy
Study type: Interventional

Summary: 
      The study was conducted to investigate the metabolic effects of three different calcium
      compounds in healthy adults.
    


Intervention name(s): calcium phosphate; Tricalcium Phosphate; Calcium carbonate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Calcium, Dietary; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: calcium carbonate; calcium phosphate; metabolic effects; human study; calcium and phosphorus metabolism
Minocycline Treatment in Retinitis Pigmentosa
Condition: Retinitis Pigmentosa; Inherited Retinal Dystrophy; Retina Disorder
MeSH terms: Retinitis; Retinitis Pigmentosa; Retinal Dystrophies; Retinal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the efficacy and safety of oral minocycline (100mg/d),
      administered for 6 months, for the treatment of patients with retinitis pigments(RP).
    

Detailed description: 
      Retinitis Pigmentosa (RP)is a sort of inherited blinding disorders and no effective or safe
      treatment are widely applied for it. The worldwide prevalence of RP is estimated to be
      1/5000. RP is characterized by degeneration of peripheral rod photoreceptor(PR) and
      associated retinal pigment epithelium(RPE) cells. Nyctalopia and visual field constriction
      are common symptoms. Cone degeneration and associated loss of central vision are typically
      followed later.

      Minocycline, a secord-generation, semi-synthetic tetracycline antibiotic, is a highly
      lipophilic molecule and can easily pass through the blood-brain barrier. Several animal
      experiments and clinical trials have reported that minocycline exert anti-apoptotic,
      anti-inflammatory and antioxidant effects in treating neurodegenerative diseases.

      We propose to test the effect and safety of oral minocycline for retinitis pigmentosa.
    

Intervention name(s): Minocycline
Intervention type(s): Drug
Intervention description(s): Tab. Minocycline 100mg po per day for 12 months
Other intervention name(s): Minocin; Minocyclinum; Minocyclin
Intervention MeSH terms: Minocycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Retinitis Pigmentosa; Minocycline; ERG; Inherited Retinal Dystrophy; Retinal Degenerative Disease
Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard in Patients Undergoing Knee Replacement
Condition: Knee Disease
Study type: Interventional

Summary: 
      Randomized controlled single blind trial for the evaluation of the treatment of the surgical
      wound healing process with Platelet-Rich-Fibrin compared to the gold standard (without
      Platelet-Rich-Fibrin) in patients undergoing knee replacement.
    


Intervention name(s): total knee replacement surgery
Intervention type(s): Procedure
Intervention description(s): total knee replacement surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children
Condition: Healthy; Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      This is a long term study on the efficacy of dietary calcium with or without probiotic
      strains in reducing the mean number of episodes and duration of diarrheal disease.
    


Intervention name(s): low calcium milk of 180 ml; regular milk of 180 ml; regular milk of 180 ml + probiotics; regular milk of 180 ml + probiotics
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): twice daily for 24 weeks; twice daily for 24 weeks; twice daily for 24 weeks; twice daily for 24 weeks
Intervention MeSH terms: Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: calcium; probiotics; diarrhea; children; Indonesia; Healthy children; acute diarrhea