bioihbjkbjnl/mcl2 huggingface dataset:
Effect of the Consumption of a Fermented Dairy Product Enriched With Plant Sterols
Condition: Mild Hypercholesterolemic Subjects
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the cholesterol lowering effect of a drinkable
      low fat fermented milk enriched with plant sterols after 3 weeks of daily consumption in
      midly hypercholesterolemic people.
    


Intervention name(s): 1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).; 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).
Intervention type(s): Other; Other
Intervention description(s): 1 = Intervention 1 (1 test product/day); 2 = Intervention 2 (1 test product/day)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Plant sterols - Hypercholesterolemia - Diet - Dairy
Pharmacokinetics and Metabolism of (14C)-Labelled PXL770
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose, single center, single-period, open-label, non-randomized, mass balance
      recovery study in healthy male subjects.
    


Intervention name(s): 14C labeled PXL770
Intervention type(s): Drug
Intervention description(s): Single administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Melatonin Levels on COVID-19 Positive Pregnant Women
Condition: COVID-19 Acute Respiratory Distress Syndrome; Pregnancy Related; Pregnancy Complications
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pregnancy Complications
Study type: Observational [Patient Registry]

Summary: 
      This study aimed to investigate the prognostic value of serum melatonin as a biomarker for
      the determination of severe COVID-19 infection in pregnant women.

      Four study groups were formed, including pregnant women with a positive COVID-19 PCR test,
      severe symptoms, and inpatient treatment. Pregnant women who had complaints similar to
      COVID-19 infection or had no complaints, but had a PCR test due to the surveillance program
      and negative test results were included in the control group.

      Methods and Main Outcome measure: Laboratory values of the cases at the time of diagnosis
      parameters were collected.

      Melatonin levels decrease in pregnant women with COVID-19 symptoms, the severity of symptoms
      increases. In addition, patients with low melatonin levels have an increase in infection
      parameters and an increase in the hospital stay.
    

Detailed description: 
      A total of 228 pregnant women included in this prospective controlled study between June
      20021 and June 2022 at Gynecology and Obstetrics Department of Health Sciences University
      Samsun Training and Research Hospital.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women with COVID-19 and control groups
      
Keywords: COVID-19; SARS-CoV-2; Melatonine; pregnancy; pregnancy outcomes
Study in Healthy Participants and Participants With Moderate Atopic Dermatitis & Optionally, Moderate Psoriasis, and/or Mild Asthma
Condition: Atopic Dermatitis; Psoriasis; Asthma
MeSH terms: Asthma; Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study will investigate the safety and tolerability of EDP1867 in healthy
      volunteers, participants with atopic dermatitis, and, optionally, in participants with
      psoriasis and/or asthma.
    

Detailed description: 
      This is a phase 1a/1b, first in human, participant and investigator-blind sponsor-unblinded
      randomized placebo-controlled multiple dose study of EDP1867 in healthy volunteers and
      participants with moderate atopic dermatitis and, optionally, moderate psoriasis, and/or mild
      asthma. This study has been designed to investigate the clinical safety and tolerability of
      EDP1867 in healthy volunteers, participants with atopic dermatitis, and, optionally, in
      participants with psoriasis and/or asthma.
    

Intervention name(s): EDP1867; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EDP1867 is an orally administered, pharmaceutical preparation of a single strain of bacteria; Placebo oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Focal Laser Ablation of Prostate Tissue
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser
      interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue
      and to gather data for the design of future studies. Intra-procedure temperature and
      concurrent rectal wall thermistor monitoring will be performed for internal validation.
      Subjects will be monitored for adverse events, and health-related quality of life (HRQOL)
      questionnaires will be obtained. Post-treatment MRI and biopsies will be obtained to evaluate
      histologic and radiologic changes. Biomarker (PSA, PCA3 and PHI) kinetics will also be
      monitored.
    


Intervention name(s): Focal Laser Ablation
Intervention type(s): Device
Intervention description(s): Focal laser ablation of prostate tissue using laser interstitial thermal therapy (LITT) under MR/ultrasound fusion guidance
Other intervention name(s): laser treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adductor Strengthening and Pelvic Floor Muscle Strengthening Exercises on Stress Incontinence in Gym Females
Condition: Urinary Incontinence, Stress
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      Stress incontinence is common form of urinary incontinence in females. The theme is to test
      if pelvic floor muscle training can be augmented by incorporating adductor muscle
      strengthening. Group A: with pelvic floor muscle strengthening plus adductor is
      strengthening. Group B: with pelvic floor muscle strengthening.
    

Detailed description: 
      Stress incontinence is common form of urinary incontinence in females. When it develops in
      gym doing women, it badly affects their performance and result in psychosocial problems in
      addition to the barriers that already have been resulted from incontinence. This study
      combines simple regime of hip adductor a strengthening with pelvic floor muscles. The theme
      is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle
      strengthening. If this comes out to be effective, this can be great contribution to gym doing
      females to improve their urinary incontinence related impairments. Woman would be encouraged
      to continue regular exercise. This will be randomized clinical trial. There are two groups
      for the compression of adductors strengthening and pelvic floor muscle strengthening. Group
      A: with pelvic floor muscle strengthening plus adductor is strengthening. Group B: with
      pelvic floor muscle strengthening. The collected data will be entered in Statistical Package
      for the Social Sciences 20.0, Descriptive and Inferential statists will be applied. Results
      and conclusion will be drawn.
    

Intervention name(s): Pelvic floor muscle plus adductor strengthening; Pelvic floor muscle exercises
Intervention type(s): Other; Other
Intervention description(s): 20 sessions of pelvic floor muscle strengthening plus adductor is strengthening; 20 sessions of pelvic floor muscle strengthening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Urinary Incontinence, Pelvic Floor Exercises
Increasing Viral Testing in the Emergency Department
Condition: Drug Use; HIV; Hepatitis C
MeSH terms: Hepatitis C; Hepatitis; Emergencies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine if a brief intervention delivered to emergency
      department patients increases the uptake of rapid HIV and hepatitis C testing in comparison
      to no brief intervention.
    


Intervention name(s): Brief motivational intervention
Intervention type(s): Behavioral
Intervention description(s): A 20-30 minute motivational based discussion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Brief intervention; Rapid testing
Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia
Condition: Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 4

Summary: 
      Hydroxychloroquine has been reported to have a clinically significant effect on the platelet
      count in systemic lupus thrombocytopenia. Its action may be due to its immune modulator
      effect. Immune thrombocytopenia (ITP) is known as an immune-mediated acquired disease
      characterized by transient or persistent decrease of the platelet count. However, refractory
      ITP is lacking of effective treatments and the efficacy of decitabine in ITP remains poorly
      understood. Data from this study may provide some idea of Hydroxychloroquine in the treatment
      of ITP in comparison to other lines of treatment as detected by the standardized definitions.
    

Detailed description: 
      This study will include patients with chronic ITP attending the out patients clinic of
      Clinical Hematology Unit of Internal Medicine Department of Assiut university Hospital to
      evaluate the safety and efficacy of hydroxychloroquine in comparison to other lines of
      treatment as detected by the standardized definitions . Detect the predictors for chronic ITP
      especially anti-nuclear antibodies (ANA) role and the effect of the proposed drugs on the
      level of anti-platelet antibodies. Evaluation of the health-related quality of life after
      treatments to answer this question; Is the most effective drug is linked to the best quality
      of life.
    

Intervention name(s): Hydroxychloroquine; vincristine; azathioprine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200mg twice daily orally for at least 12 weeks; 1mg intravenous weekly for 4 weeks; dose 100mg daily for at least 3 weeks
Other intervention name(s): imuran
Intervention MeSH terms: Hydroxychloroquine; Vincristine; Azathioprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glutamate-Glutamine Cycling (VCYC) During Cocaine Abstinence Using 1H-MRS
Condition: Cocaine Dependence; Healthy
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to look at the relationship between brain glucose utilization,
      neurotransmission (e.g., glutamate, also known as the main excitatory amino-acid
      neurotransmitter in the brain), and synaptic density. This relationship will be explored in
      the brain's prefrontal cortex, an area important in decision-making and impulsivity.
    


Intervention name(s): N-acetyl cysteine; [18F]FDG PET scan; 1H MRS; [11C]APP311 PET scan
Intervention type(s): Drug; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Upon completion of baseline (abstinence) 1H-MRS scanning, CU and HC subjects will participate in two additional 1H-MRS scans, including after 2 weeks of placebo and 2 weeks of NAC administration (3600 mg/day) given in double-blind, randomized, counterbalanced order.; All subjects will undergo [18F]FDG PET to establish previously demonstrated reductions in glucose utilization in PFC and assess VS/nucleus accumbent metabolism at baseline.; All subjects will undergo three magnetic resonance spectroscopy (1H-MRS) scans at 7T, including before and after two-weeks of placebo and NAC administration.; All subjects will undergo [11C]APP311 PET imaging to investigate whether there are differences in synaptic integrity / neuronal plasticity in the brains of individuals abstinent from cocaine compared to healthy controls at baseline.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
To Evaluate 24-hr Glucose After OD vs BD AZD1656
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the 24-hour glucose profiles in diabetic patients
      treated with metformin following once daily and twice daily oral dosing
    


Intervention name(s): AZD1656
Intervention type(s): Drug
Intervention description(s): Oral suspension
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type II Diabetes; 24 hour glucose profile
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema
Condition: Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be composed of 3 periods for all participants: Screening, 28-day Treatment
      period, and Follow-up visit (approximately 28 days after the final dose).
    


Intervention name(s): GSK2798745
Intervention type(s): Drug
Intervention description(s): GSK2798745 will be administered.
Intervention model: Single Group Assignment
Intervention model description: This is a multi-center, open-label, single arm study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic macular edema; GSK2798745; Refraction; Visual acuity.
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Chronic Heart Failure and Chronic Obstructive Pulmonary Disease Patients
Condition: Cachexia; Chronic Obstructive Pulmonary Disease; Chronic Heart Failure
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Heart Failure; Cachexia
Study type: Interventional

Summary: 
      To test the compliance, tolerance, safety and to get preliminary insights into the efficacy
      of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and
      antioxidants) designed to prevent or delay cachexia and anorexia in patients with chronic
      heart failure (CHF) or chronic obstructive pulmonary disease (COPD).
    


Intervention name(s): oral nutrition supplement, food for special medical purposes
Intervention type(s): Dietary Supplement
Intervention description(s): 2 servings of 200-300 ml per day, treatment period: 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
The Acceptability and Feasibility of an Alternative to Routine Follow-up Visit After Medical Abortion in Vietnam
Condition: Medical Abortion
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will compare the efficacy and acceptability of post-medical abortion follow-up by
      assigning women to either 1) alternative follow-up via routine semi-quantitative pregnancy
      test and a self-administered follow-up questionnaire, or 2) the standard of care: a routine
      follow-up visit including a bimanual exam and vaginal ultrasound.

      The goal of the study is to provide answers to the following questions:

        1. Is a follow-up protocol that employs a self-administered questionnaire and at home use
           of a semi-quantitative pregnancy test effective at identifying women with ongoing
           pregnancies?

        2. Is an innovative follow-up protocol more acceptable to women and providers than the
           current standard of care?

        3. Is an innovative follow-up protocol feasible to implement in abortion services in
           Vietnam?
    


Intervention name(s): Alternative follow-up
Intervention type(s): Other
Intervention description(s): After mifepristone administration, women will be provided with a second semi-quantitative pregnancy test and a self-administered checklist. Women will be instructed to complete the checklist and perform the pregnancy test at home on an assigned data two weeks after mifepristone administration. On the assigned date, women will also be contacted by phone by the clinic staff. Women will be asked to confirm whether they completed the pregnancy test and checklist and asked to report on the results of both tests. Provider will review the women's responses to the checklist and confirm whether, based on the woman's responses, she should return for a follow up visit. During the follow-up phone call, women will also be asked about the satisfaction and acceptability of the alternative follow-up procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: medical abortion
Probiotic-enriched Artichoke in Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The aim of the present randomized double-blind controlled crossover study is to compare the
      effects of the 15-day consumption of artichokes enriched with the probiotic Lactobacillus
      paracasei LMGP22043 with those of ordinary artichokes on treatment preference, satisfactory
      relief of symptoms, bowel habit and the modulation of SCFA production in a group of patients
      suffering from functional constipation.
    

Detailed description: 
      Functional constipation is a common problem in westernized societies and is characterized by
      different gastrointestinal symptoms.Different therapeutic strategies have been proposed, but
      a new therapeutic approach for constipation could be based on the modulation of intestinal
      microflora by administering prebiotics and/or probiotics. Currently, probiotic products are
      mainly incorporated in fermented milk-based products or concentrated probiotic preparations.
      To enlarge the range of choice and to exploit the nutritional qualities of plant matrices, an
      innovative line of probiotic vegetable products such as artichokes has been developed. The
      use of these vegetables containing live probiotic strains can take advantage of some their
      peculiar features for growth and improved bacterial survival. Artichokes can, therefore, work
      as valid "active" vehicles for the transport and release of adequate amounts of bacterial
      populations.
    

Intervention name(s): Lactobacillus paracasei IMPC 2.1 LMGP22043; Ordinary artichokes
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): participants will complement their usual lifestyles and dietary intakes with probiotic artichokes, enriched with the probiotic strain Lactobacillus paracasei IMPC2.1 (LMGP22043). The product contains approximately 1.20 x 10^8 CFU of live probiotic cells of Lactobacillus paracasei IMPC 2.1 LMGP22043 per gramme, which resulted in a daily dose of about 2 x 10^10 CFU.; Probiotic artichokes will be tested against ordinary artichokes (probiotic free) of identical shape, texture, and appearance produced by the same manufacturer. Artichokes will be put in similar packages and there will be no way to distinguish between the two products.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Artichokes; Constipation; Functional Foods; Prebiotics; Probiotics
Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis
Condition: Active Tuberculosis
MeSH terms: Tuberculosis
Study type: Observational

Summary: 
      There was no sensitive and specific biomarker for tuberculosis infection, disease progression
      and predicting the prognosis of treatment. Therefore, the investigators aimed to investigate
      and evaluate the newer biomarker for the diagnosis of TB infection. To investigate the new
      biomarker for TB infection, the investigators will recruit the participants including active
      TB patients, healthy household contacts, healthy community control.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        active TB patients group : from the referred center TB care clinic healthy control : from
        the community sample
      
Biospecimen description: 
      peripheral blood and serum will be retained
Pulse ACTH vs. MP for MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      We hypothesize that corticotropin or adrenocorticotrophic hormone (ACTH), administered as
      Acthar Gel® (MANUFACTURER NAME) is effective in the control of clinical disease activity as a
      pulse therapy for relapsing-remitting MS when added to standard treatment with
      beta-interferon.

      We wish to determine whether ACTH, when administered as clustered monthly intramuscular
      injections (monthly pulse therapy) as add-on to beta-interferons, may be a safe and effective
      alternative to monthly pulse therapy with MP. In addition, we hypothesize that pulse therapy
      with ACTH alters immune function to favor a regulatory, rather than a pro-inflammatory T cell
      environment.
    

Detailed description: 
      Please see the final manuscript
    

Intervention name(s): ACTH; Methylprednisolone
Intervention type(s): Drug; Drug
Intervention description(s): Subjects assigned to the ACTH arm will receive ACTH (Acthar gel) as intramuscular (IM) injections once a day for 3 consecutive days on a monthly basis, for 12 consecutive months. The dosage of ACTH will be 80 units per injection, for a total of 240 units over the three day period.; Subjects assigned to the MP arm will receive intravenous (IV) infusions of 1 gram of MP once a month for 12 months
Other intervention name(s): Acthar Gel; Solumedrol
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; ACTH; Steroids