bioihbjkbjnl/mcl2 huggingface dataset:
Study to Find Out How Symptoms Severity Changes During the Standard Course of Treatment With the Cream Relief Pro and Suppositories Relief Pro (Active Ingredients Are Fluocortolone + Lidocaine) in Patients Suffering From Twisted and Bulging Veins in the Rectal Area (Acute Hemorrhoids)
Condition: Acute Hemorrhoids
MeSH terms: Hemorrhoids
Study type: Observational

Summary: 
      In this study researcher wanted to learn more about the changes of biggest twisted and
      bulging veins in the rectal area (hemorrhoids) and changes of symptoms during a treatment
      period with the cream Relief Pro and suppositories Relief Pro. The study collected
      information on the treatment satisfaction of patients and their physicians with the
      prescribed treatment by using questionnaires. There were 3 visits at the physician's clinic
      for this study: one initial visit and 2 follow-up visits over a period of 2 weeks.
    


Intervention name(s): Relief Pro cream; Relief Pro rectal suppositories
Intervention type(s): Drug; Drug
Intervention description(s): Relief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice.; Relief Pro rectal suppositories: 1.0 mg Fluocortolone + 40 mg Lidocaine; Administration according to clinical practice
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult male and female patients with acute hemorrhoids from Russia.
Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine the proportion of participants with
      relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS)
      after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017).

      Secondary objectives are: to determine the severity and frequency (measured by flu-like
      symptom score [FLS-S]) of FLS in these participants; to determine the duration (measured in
      number of hours) of FLS in these participants; to determine the effect of BIIB017 on other
      participant-reported outcomes, including treatment satisfaction (measured with the Treatment
      Satisfaction Questionnaire for Medication [TSQM]) and disability status (measured with the
      Patient Determined Disease Steps [PDDS]) over a 56-week period; to determine whether
      interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism); to
      assess the use of additional medications (in addition to current medications used to treat
      FLS) to relieve BIIB017-related FLS; to determine the incidence of adverse events throughout
      the study period; to characterize the immunogenicity profiles of participants switching from
      prior IFN-β therapy to BIIB017.
    


Intervention name(s): BIIB017; naproxen
Intervention type(s): Drug; Drug
Other intervention name(s): Plegridy; peginterferon beta-1a; PEGylated interferon beta-1a; PEG IFN β-1a; naproxen sodium; Aleve; NSAID; long-acting nonsteroidal anti-inflammatory drug
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: flu-like symptoms
Momordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency
Condition: Uncomplicated Plasmodium Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      Currently, the first-line combination of artemisinin, piperaquine and prima-quine is quite
      effective in controlling malaria, however, the threat of spread of drug-resistant parasites
      has been reported. A study is conducted to assess the efficacy and safety extract of bitter
      melon (Momordica charantia/MC) regimens compared to the combination of dihydroartemisinin
      piperaquine primaquine (DHP+PQ) on the sexual and asexual stage of P. Falciparum
      uncomplicated in Sumba Barat Daya District, Indonesia
    

Detailed description: 
      The Study was conducted in Kori Primary Health Cender, Sumba Barat Daya District, East Nusa
      Tenggara Province on Sumba Island.

      The study subject received either 3 day of dihydroartemisinin-piperaquine and primaquine 1
      day on first day (DHP+PQ) or extract of bitter melon (Momordica charantia/MC) + Placebo 1 day
      on first day according to their body weight.

      Patients with fever or history of fever within the past 24 hours were screened by microscopic
      examination of giemsa stained tihick blood films to detect Plasmodium falciparum infection.

      All Patient were allocated by single blind randomization to receive DHP (on day 0 to day
      2)+PQ (on day 0 only) or extract of bitter melon (Momordica charantia/MC) (on day 0 to day
      2)+placebo (on day 0 only). The procedures of drug administration in the study were as
      follows:
    

Intervention name(s): Dihydroartemisinin; Piperaquine; Primaquine; Momordica Charantia Extract
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days; piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days; Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only; Momordica charantia extract capsules at a dose of 325 mg were given to patients for 3 days
Other intervention name(s): 1st group; 1st group; 1st Group; 2nd group
Intervention MeSH terms: Primaquine; Piperaquine; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the patient comes to the primary health care facility, is examined by a doctor, if malaria is suspected, a parasite examination is carried out in the laboratory. If positive for falciparum malaria and based on the results of the doctor's examination meet the criteria as research subjects, then the drug is given based on the random table that has been provided.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Parasite number, clinical symtomps, immunomodulator
A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, non-randomized, open-label study will assess the pharmacokinetics of
      aleglitazar after administration of single and multiple oral doses in healthy Chinese
      volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated
      oral doses once daily from Day 5 to Day 14. Anticipated time on study, including screening
      and a 2-week follow-up, is up to 8 weeks.
    


Intervention name(s): aleglitazar
Intervention type(s): Drug
Intervention description(s): Single oral dose Day 1, repeated oral dose once daily Days 5-14
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Study on Heart Rate Variability in Cardiac Transplant Recipients With Exercise and After Exercise Training
Condition: Cardiac Transplant Disorder
Study type: Interventional

Summary: 
      The purpose of the study was to investigate the changes on heart rate variability, exercise
      capacity, activities of daily living, and quality of life after aerobic exercise training in
      cardiac transplant recipients.
    


Intervention name(s): Exercise training; usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): exercise training; received usual medical care after heart transplantation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiac transplant recipients; Heart rate variability; Exercise training
90Y-IBRITUMOMAB Tiuxetan and AHCI With HD Chemotherapy and Autologous Transplantation for Relapsed or Resistant NHL
Condition: Lymphoma, Non-Hodgkin; Blood and Marrow Transplant (BMT)
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1

Summary: 
      To test a new way to approach hematopoietic stem cell transplantation for Relapsed or
      Resistant Non-Hodgkin's Lymphoma.
    

Detailed description: 
      This is a single center phase I dose escalation trial of a single course of IDEC-Y2B8
      (90Y-ibritumomab tiuxetan, Zevalin) with autologous peripheral blood progenitor cell infusion
      followed by high dose chemotherapy and AHCT for patients with relapsed or refractory B-cell
      NHL. In step one, an imaging dose of IDEC-In2B8 (111In- ibritumomab tiuxetan, Zevalin) will
      be followed one week later by IDEC-Y2B; both will be preceded by an infusion of 250 mg/m2
      rituximab. Imaging will be done immediately (within 1 hr), at 4 - 6 hours and at 1, 3, and 6
      days after 90Y-ibritumomab tiuxetan.
    

Intervention name(s): 90Y Ibritumomab tiuxetan
Intervention type(s): Drug
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Fetal, Infant, and Early Childhood Exposures on Adult Cancer Risk in Women
Condition: Breast Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Gathering information about pregnancy, infancy, and early childhood exposures may
      help doctors identify cancer risk factors, and may help the study of cancer.

      PURPOSE: This natural history study is looking at the effects of fetal, infant, and early
      childhood exposures on adult cancer risk in women.
    

Detailed description: 
      OBJECTIVES:

        -  Determine if fetal, infant, and early childhood exposures are associated with adult
           cancer risk in women.

      OUTLINE: Mothers of nurses complete questionnaires to collect maternal data, such as
      pregnancy weight gain, diet during pregnancy, maternal pre-eclampsia, gestational diabetes,
      gestational age at birth, birth weight, and infant feeding practices. Maternal data is linked
      to other data collected from critical time periods in the nurses's life cycle, such as
      menarche, first pregnancy, or adult dietary intake.
    

Intervention name(s): questionnaire administration; evaluation of cancer risk factors
Intervention type(s): Other; Procedure
Keywords: breast cancer; unspecified adult solid tumor, protocol specific
A Study to Assess the Effect of Food Intake and Drug-drug Interactions of E7090 When Co-administered With Rabeprazole or Rifampin in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will have three parts: Part A, Part B, and Part C. The primary purpose of Part A
      is to evaluate the effect of food on the rate and extent of E7090 absorption following single
      oral doses of E7090 in healthy participants, Part B is to evaluate the effects of rabeprazole
      (a gastric acid-reducing agent) on the rate and extent of E7090 absorption following single
      oral doses of E7090 in healthy participants, Part C is to evaluate the effects of rifampin (a
      strong Cytochrome P450 3A [CYP3A] inducer) on pharmacokinetics (PK) of single oral doses of
      E7090 in healthy participants.
    


Intervention name(s): E7090; Rabeprazole 20 mg; Rifampin 600 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablet.; Rabeprazole 20 mg (2 tablets, each of 10 mg) oral tablet.; Rifampin 600 mg (4 capsules, each of 150 mg) oral capsule.
Intervention MeSH terms: Rifampin; Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: E7090; Food-effect; Drug-drug Interactions; Rabeprazole; Rifampin
The Effect of Breakfasts Varying in Protein Source on Appetite and Energy Intake
Condition: Obesity
Study type: Interventional

Summary: 
      Over the last decades, changes in the diet and lifestyle have led to overall energy imbalance
      becoming commonplace and the emergence of an obesity epidemic with more than 1.6 billion
      adults being overweight.

      Consumption of foods that can affect appetite by increasing satiety could regulate the total
      energy intake and thus body weight. There is data suggesting that the macronutrient
      composition of the foods and especially protein content may have a potent role on satiety.
      However, the type of protein appears to play a role in satiety possibly due to the different
      balance of the amino acid profile.

      The research project is dedicated to identify the source (animal or plant) and the optimized
      protein quantity needed to accelerate satiation, suppress appetite and extend satiety until
      hunger appears again.

      It is hypothesized that the consumption of animal derived protein-enriched meals will induce
      a reduction in hunger through the impact on gut hormones and peptides that are closely
      related to the short-term regulation of food intake.
    


Intervention name(s): Breakfasts varying in protein source content on appetite
Intervention type(s): Dietary Supplement
Intervention description(s): In this randomized, within-subject study, subjects are asked to consume 4 iso-energetic and iso-volumetric puddings as breakfast (20% of estimated energy requirements) with varying distribution of protein sources. The objective is to identify the protein source and the distribution on suppressing appetite.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Appetite; Amino acids; Protein Source
Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo®
      Forte and IDP-126 Vehicle Gel.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed
      to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison with Epiduo®
      Forte gel and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study,
      subjects must be at least 12 years of age and have a clinical diagnosis of moderate to severe
      acne (defined as an Evaluator's Global Severity Score [EGSS] of 3 or 4), presenting with
      30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory
      facial lesions (open and closed comedones), and ≤ 2 facial nodules.
    

Intervention name(s): IDP-126 Gel; IDP-126 Vehicle Gel; Epiduo® Forte Gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Gel applied to face once daily in the evening.; Gel applied to face once daily in the evening.; Gel applied to face once daily in the evening.
Other intervention name(s): IDP-126; Vehicle; Epiduo® Forte
Intervention MeSH terms: Adapalene, Benzoyl Peroxide Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Bacopa Monnieri on Working Memory and Cognitive Processing in Student
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of Bacopa Monnieri on working memory and
      cognitive processing in student.
    

Detailed description: 
      Learning and working memory are two of the key role for studying and work successful for
      student particular the high school student who study hard and preparing themselves for the
      graduate study. The consumption of brain booster product or functional food for improving
      memory has gained much attention. It has been reported that Bacopa Monnieri could improve
      learning and working memory in elderly subject by improving the N100 and P300 event related
      potential. Therefore, Bacopa Monnieri might be the potential product for improving the
      learning and working memory in student particular high school student.
    

Intervention name(s): Placebo; Bacopa Monnieri 300 mg/day; Bacopa Monnieri 600 mg/day
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects are received Placebo once daily for 16 weeks.; Subjects are received Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks.; Subjects are received Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bacopa Monnieri; Working memory; Cognitive processing; Student
Sex Hormones and Pericardial Adipose Tissue
Condition: Pericardial Adipose Tissue and Sex Hormones
Study type: Observational

Summary: 
      In this study, our aim is to show the relation between sex hormones and PAT and to confirm
      whether PAT is associated with coronary artery calcification (CAC) in different testosterone
      levels in the males.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        3161 men (45-84 years old; white, black, Hispanic, or Chinese) at 6 centers in the United
        States
Glasgow Coma Scales and General Anesthesia
Condition: Anesthesia Awareness
MeSH terms: Intraoperative Awareness
Study type: Interventional

Summary: 
      The study evaluates the general anesthesia management with BIS monitorization in terms of
      hemodynamic stability, drug concentrations and drug consumption in patients who underwent
      surgery due to intracranial pathology and who were divided in three different GCS groups.
    

Detailed description: 
      BIS monitoring is mostly used for anesthesia depth and sedation level follow-up, however it
      can also be used for monitoring consciousness after resuscitation of cases with acute brain
      injury and cardiac arrest. It is not always possible to monitor and objectively measure the
      changes in the level of consciousness in clinical practice. Therefore, device-based methods
      have been introduced in monitoring the state of consciousness. Bispectral index (BIS)
      monitoring may be preferred in follow up of the state of consciousness in critical patients
      such as those with acute brain injury, in terms of ease of use, ability to obtain numerical
      results and continuous monitoring. BIS monitoring is mostly used for follow up of anesthesia
      depth and sedation level, while it can also be applied for monitoring state of consciousness
      following resuscitation in cases with acute brain injury and cardiac arrest.In this study, we
      aimed to investigate general anesthesia management performed by bispectral index monitoring
      in patients who underwent surgery due to intracranial pathology and with different Glasgow
      Coma Scales.
    

Intervention name(s): Bispectral index (BIS) monitoring; Sevoflurane
Intervention type(s): Device; Drug
Intervention description(s): When the patients were taken to the operation table, they were monitored with the BIS. we used sevoflurane drug; we used sevoflurane drug at inoperative
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Bispectral index; Glasgow Coma Scale; intracranial pathology
A Study of C105 on Cognitive Dysfunction in Persons With Multiple Sclerosis
Condition: Cognition Disorders; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Cognitive Dysfunction; Cognition Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of C105 in treating the
      cognitive deficits that can occur due to multiple sclerosis.
    


Intervention name(s): C105
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; cognitive impairment; cognitive dysfunction; Cognitive Dysfunction associated with Multiple Sclerosis
Joint Ultrasound Evaluation of Asymptomatic Rheumatic Feet
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      Objectives: The aims of the present study were to compare ultrasound on asymptomatic feet of
      patients with rheumatoid arthritis (RA) and normal controls, determine the association
      between ultrasound and global disease activity, function and goniometric measures in patients
      with RA and determine the correlation between ultrasound and radiography in the detection of
      bone erosion.

      Methods: The foot joints (talocrural, talocalcaneal, talonavicular, naviculocuneiform,
      calcaneocuboid, 5th tarsometatarsal and 1st to 5th metatarsophalangeal [MTP] joints) of 50
      healthy subjects and 50 patients with RA (all with asymptomatic feet) were evaluated
      bilaterally regarding quantitative/semi-quantitative synovitis, semi-quantitative Power
      Doppler (PD) signals and erosion using ultrasound. Statistical significance was set to 5%.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Rheumatoid Arthritis
      
Keywords: Rheumatoid arthritis; Ultrasonography; Synovitis; Foot joints
Zein Nanoparticles for Glycemic Control
Condition: PreDiabetes; Overweight and Obesity; Adult ALL
MeSH terms: Overweight; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The use of zein nanoparticles as vehicles for drug delivery is under study, but of the
      effects observed in empty nanoparticles, in laboratory animals, the reduction of glucose
      levels was something worth studying. Thus, the present research on patients with prediabetes
      has been proposed. The objective is to assess the efficacy of zein nanoparticles on the
      glycemic control. For this purpose, a randomized, double blind crossover study has been
      designed.

      Target sample size is 60.
    


Intervention name(s): Zein nanocapsules; control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 g of Zein nanoencapsulated daily; 1 g of Zein non-encapsulated daily
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised, double blind crossover intervention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prediabetes; Glycemia and glucose metabolism; Zein; Glucose monitoring