bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3041658 in Adults With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The reason for this study is to see if the study drug LY3041658 is effective in participants
      with moderate-to-severe hidradenitis suppurativa (HS).
    


Intervention name(s): Placebo; LY3041658
Intervention type(s): Drug; Drug
Intervention description(s): Administered IV; Administered IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Physiopathology of Sodium Retention in Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly; Hypernatremia
Study type: Interventional

Summary: 
      Acromegaly is a disease due to an excess of growth hormone that abnormally occurs in
      adulthood. It is due to a benign (non cancerous) tumor located in a particular part of the
      brain that secretes several hormones, the hypophysis. The excess of growth hormones in adults
      induces an increase in bone (resulting in large enlargement of extremities), and organs. The
      disease is complicated by the apparition of cardiovascular events including retention of
      water, salt in the tissues and increase in blood pressure, that altogether might major the
      mortality of the patients. The investigators recently got experimental data suggesting that
      the retention of water and salt is mainly due to the activation by the growth hormone of a
      renal transporter of sodium. Because this transporter is highly sensitive to amiloride, a
      well know diuretic, the investigators hypothesize that this drug will be very efficient in
      treating the hypertension in patients, as compared to another diuretic, furosemide.
    

Detailed description: 
      To prove this, we compared the response to amiloride administrated before and after treatment
      of acromegaly in the same subject. We will also compare the response to furosemide
      administrated before and after treatment of acromegaly in the same subject. We expected that
      the response to amiloride will be greater before than after treatment, while the response to
      furosemide will be lesser before than after treatment.

      Detailed Description:

      Definition: Extended description of the protocol, including information not already contained
      in other fields, such as comparison(s) studied.

      Patients will be recruited in the Department of Endocrinology and Reproductive diseases in
      BICETRE University Hospital and will be explored in the Centre for Clinical Investigation of
      HEGP. Investigations will be performed during 4 separate day-hospital stays (2 pre-treatment
      and 2 post treatment) in the CIC of HEGP. The tests will consist of blood and urine sample
      collections before and after a single dose administration of furosemide or amiloride. The
      tests will be performed before treatment of acromegaly in random order and separated by
      48hours, interval performed before treatment, and repeated in the same order after
      normalization of IGF1 by appropriate treatment.

      The study will last for 2 years, with a 12 months maximal participation of each patient
    

Intervention name(s): furosemide
Intervention type(s): Drug
Intervention description(s): furosemide
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Growth Hormone; Epithelial sodium channel; Hypertension; A Furosemide; Nasal Mucosa
The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality
Condition: Vasomotor; Syndrome; Sleep
Study type: Interventional

Summary: 
      The research was planned as a prospective, randomized controlled experimental study to
      determine the effect of online laughter yoga applied to menopausal women on vasomotor
      symptoms (VMS) and sleep quality. Research Hypotheses ar below; H0: Online laughter yoga has
      no effect on VMS. H1: Online laughter yoga has an effect on VMS. H0: Online laughter yoga has
      no effect on sleep quality. H1: Online laughter yoga has an effect on sleep quality.
    

Detailed description: 
      The sample will consist of 82 menopausal women aged 40-60 years and experiencing at least one
      of the VMS. Intervention group: Online laughter yoga will be applied to women by a researcher
      who has an internationally approved certificate. The intervention group will receive eight
      online laughter yoga sessions, two sessions per week for four weeks. In this study, the
      number of laughter yoga sessions was determined in line with the studies in the literature.
      Each laughter yoga session is planned to last approximately 40-45 minutes. Each session of
      laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike
      play and laughter.

      No intervention will be applied to the control group.
    

Intervention name(s): Laughter yoga
Intervention type(s): Other
Intervention description(s): Although the history of laughter yoga dates back to ancient times, its use in medicine has become widespread in the 21st century, while it is used to reduce pain, anxiety, stress, depression and fatigue, it is also a method that can be used to accelerate immunity, quality of life, happiness, sleep quality and recovery.
Other intervention name(s): Laughter therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel, two arm, randomized controlled clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: vasomotor symptoms; sleep quality; menopause; laughter yoga; laughter therapy
Incidence and Risk Factors of Early Onset Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Early onset colorectal cancer (cancer in person younger than 50 years) has increasing
      incidence last years. The aim of our study was to assess the real-life incidence of early
      onset colorectal cancer, advanced neoplasias (colorectal cancer and/or advanced adenoma) and
      all neoplastic lesions in total in a single non-university endoscopic center.
    

Detailed description: 
      The investigators retrospectively assessed the incidence of all neoplastic lesions, advanced
      neoplasias and colorectal cancer in population under 50 years of age compared to population
      50 years and older. The investigators collected the data from all colonoscopic examinations
      performed in non-university hospital Frydek-Mistek from January 2012 to the end of June 2021.
    

Intervention name(s): colonoscopy
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        all patients who were indicated for colonoscopic examination (all indications) in period
        january 2012 to the end of june 2021
Time Course of Procalcitonin and C Reactive Protein in Septic Patients Under Treatment With Corticosteroids
Condition: Sepsis
MeSH terms: Sepsis
Study type: Observational

Summary: 
      A systemic treatment with corticosteroids has been advocated for various bacterial infectious
      diseases. Since the production of CRP is down-regulated by corticosteroids, a smaller
      increase or a more rapid decrease of this acute phase protein will:

        1. suggest attenuated systemic inflammation, but

        2. does not necessarily reflect adequate therapy of the infection.

      For several reasons (good diagnostic tool for sepsis, induction not decreased by
      immunosuppressive therapy), procalcitonin could be a better marker for activity of sepsis in
      patients under corticosteroids. As this issue has not yet been examined the investigators
      will prospectively study the time-course of PTC and CRP in a well-defined septic patient
      group, that in adjunction to antibiotic therapy also received systemic corticosteroid
      treatment and compare it to a similar group without corticosteroid treatment.
    


Time perspective: Prospective
Keywords: Procalcitonin; Sepsis; Corticosteroids
Dosage Study for Vigamox Eye Drops Prior to Intravitreal Injections
Condition: Intravitreal Injection Patients
Study type: Interventional
Phase: Phase 4

Summary: 
      Antibiotic eye drops are being used before and after intravitreal injections. Currently there
      is no study indicating the benefit of there usage or their dosage.

      In this study we compare the efficacy of Vigamox eye drops (antibiotic)starting 3 days prior
      to the injection versus 1 day prior to intravitreal injection.
    


Intervention name(s): Vigamox
Intervention type(s): Drug
Intervention description(s): eye drops 3 times day either 1 or 3 days prior to intravitreal injection
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vigamox, topical antibiotics, Intravitreal injections, macular degeneration, endophthalmitis
A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the mass balance and safety of [14C] ABBV-903 in
      healthy male volunteers following a single oral dose administration.
    


Intervention name(s): ABBV-903
Intervention type(s): Drug
Intervention description(s): Solution; Oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteer; ABBV-903
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      The study seeks to provide evidence of the effectiveness and obtain patient reported outcome
      (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir
      (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C
      virus infected participants.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic Hepatitis C (CHC)
      
Keywords: Chronic Hepatitis C; Dasabuvir; Paritaprevir/r/Ombitasvir; Observational Study; Quality of Life; Fibrosis; Cirrhosis; Work Ability
Safety and Pharmacokinetics of ELB353 in Healthy Men
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to study the safety and tolerability of repeated oral doses of
      ELB353, to evaluate the plasma levels of ELB353 and to study their effect on substances
      mediating inflammation.
    


Intervention name(s): Placebo; ELB353
Intervention type(s): Drug; Drug
Intervention description(s): Oral, 10 days; Oral, 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis
Condition: Active Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the clinical activity of interferon beta-1a
      in participants with moderate to severe ulcerative colitis (UC). Secondary objectives of this
      study are to determine (i) the safety and tolerability of interferon beta-1a in participants
      with moderate to severe UC, and (ii) the percentage of participants, with a decrease in the
      Simple Clinical Colitis Activity Index (SCCAI) score of ≥3 points at Week 8.
    


Intervention name(s): BG9418 (Interferon beta-1a); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Avonex IM injection, self-administered per protocol; Placebo IM injection, self-administered per protocol.
Other intervention name(s): Avonex®
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
The Effect of CBT- Based Weight Loss Program on Obesity
Condition: Obesity; Hypercholesterolemia; Diabetes Mellitus, Type 2; Anhedonia
MeSH terms: Anhedonia; Obesity; Diabetes Mellitus, Type 2; Hypercholesterolemia; Weight Loss
Study type: Interventional

Summary: 
      The investigators purpose is to study how CBT (cognitive behavioral therapy)-based weight
      loss program affects on eating behavior, weight loss and risk factors for CHD (coronary heart
      diseases)and type 2 diabetes. Moreover, the investigators aim is to recognize subjects
      suffering from anhedonia (one of the core symptoms of depression, lack of pleasure) and
      follow how they benefit from the program in order to achieve maintained weight loss. Also,
      the associations between weight loss, physical activity and musculoskeletal disorders are
      studied.
    

Detailed description: 
      Obesity is an increasing problem and effective weight loss methods are needed. The study is
      randomized follow-up study with 9 months intervention and three (3) years follow-up period.
      The study is organized in Oulu University Hospital, Department of Internal Medicine. Eighty
      (80)obese, 20-65 years, study subjects will be randomized into intervention or control group.

      The hypothesis of the CognObe study is: CBT (cognitive behavioral therapy)-based weight loss
      program is successful in sustained and favourable change in eating behavior and weight as
      well as decreased risk for coronary heart diseases or type 2 diabetes.
    

Intervention name(s): Cognitive behavioral therapy -based weight loss program
Intervention type(s): Behavioral
Intervention description(s): CBT-based program includes 20 group visits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multicenter Bone and Joint Health Study
Condition: Osteoarthritis,Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      The purpose of this study is to investigate opportunities for prevention and treatment of
      knee osteoarthritis (OA) by evaluating potentially modifiable risk factors for disease and
      poor pain and physical function outcomes especially among those with early or mild knee
      symptoms. The goal of the study is to find novel strategies to prevent disease at an early
      stage and to limit the impact of disease once it has occurred.
    

Detailed description: 
      MOST study participants in the "Existing Cohort" (3,026 subjects) were enrolled in the
      original study in 2003-2005. Surviving Existing Cohort participants without end-stage knee
      osteoarthritis will be asked to participate in the 144-, 152-, 160- and 168-month follow-up
      contacts. In addition, in 2016-2018 the cohort will be enriched by the recruitment of an
      additional 1,500 "New Cohort" participants with early or mild knee symptoms. The goal of the
      study is to find novel strategies to prevent disease at an early stage.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The purpose of this study is to investigate opportunities for prevention and treatment of
        knee osteoarthritis by evaluating potentially modifiable risk factors for disease and poor
        pain and physical function outcomes especially among those with early or mild knee
        symptoms. The goal of the study is to find novel strategies to prevent disease at an early
        stage and to limit the impact of disease once it has occurred.
      
Biospecimen description: 
      Existing Cohort biospecimens were collected at enrollment, 30-month and 60-month follow-up.
      New Cohort biospecimens will be collected at 144-month which will be their enrollment visit).
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Condition: Abscess; Wound Infection; Surgical Site Infection; Cellulitis
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Cellulitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy)
      of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral
      linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial
      skin or skin structure infections.
    


Intervention name(s): IV Dalbavancin; Vancomycin/Linezolid
Intervention type(s): Drug; Drug
Intervention description(s): IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8; IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
Intervention MeSH terms: Vancomycin; Linezolid; Dalbavancin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Determine Pharmacokinetic Characteristics of LY03010 Versus INVEGA SUSTENNA® in Schizophrenia Patients
Condition: Schizo Affective Disorder; Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will look at the Characteristics of LY03010 Versus INVEGA SUSTENNA® in the blood
      of Schizophrenia Patients
    


Intervention name(s): LY03010; Invega Sustenna 156 MG in 1 ML Prefilled Syringe
Intervention type(s): Drug; Drug
Intervention description(s): Single Dose of LY03010 at 351 mg or 156 mg or 117mg; Single Dose at 156mg
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia
Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study
Condition: Acute Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Our overall objective is to model a pediatric Acute Asthma Clinical Decision Rule (ADR) for
      personalized medicine by identification of treatment-response phenotypes that are important
      determinants of outcome. The Specific Aim of this study is to determine the feasibility of
      this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different
      albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr.
      Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.
    

Detailed description: 
      The objective of this study is to determine the feasibility of this approach by enrolling a
      pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2
      of which will use 10mg/hr and 2 of which will use 25mg/hr. Participants are randomized in
      randomly permuted blocks of four. Within these dosages there will be a pulsed-treatment
      regimen and a continuous regimen.
    

Intervention name(s): Albuterol
Intervention type(s): Drug
Intervention description(s): Nebulized albuterol
Other intervention name(s): proventil
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Acute asthma; Pediatrics
Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS
Condition: Peritoneal Dialysis, Continuous Ambulatory
Study type: Interventional

Summary: 
      Bioimpedance-guided fluid management in peritoneal dialysis patients may provide better
      protection of residual renal function over 1 year period, compared with management guided by
      clinical information alone - such as blood pressure, body weight, and physician's physical
      examination.
    


Intervention name(s): BCM-guided fluid management; Fluid management based on the clinical information alone
Intervention type(s): Device; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: fluid; edema
Risk Factors for Developing a Blood Clot in Patients Who Are Undergoing Cancer Treatment for Newly Diagnosed Gliomas
Condition: Brain and Central Nervous System Tumors; Thromboembolism
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms; Thromboembolism
Study type: Observational

Summary: 
      RATIONALE: Patients with gliomas may be at risk for developing blood clots. Learning about
      the risk factors for developing blood clots may help doctors plan better treatment for
      gliomas.

      PURPOSE: This clinical trial is studying risk factors for developing blood clots in patients
      who are undergoing cancer treatment for newly diagnosed gliomas.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the overall hazard rate of first venous thromboembolism per person-year of
           follow-up in patients undergoing antineoplastic therapy for newly diagnosed high-grade
           gliomas.

        -  Correlate ABO blood type with incidence of venous thromboembolism in these patients.

        -  Correlate factor VIII level with incidence of venous thromboembolism in these patients.

      Secondary

        -  Determine the overall and individual incidence rate of thromboembolism in these
           patients.

        -  Correlate clinical variables, such as type of antineoplastic treatments, Karnofsky
           performance status, and type of tumor, with incidence of venous thromboembolism in these
           patients.

        -  Correlate demographic factors, such as age, with incidence of venous thromboembolism in
           these patients.

      OUTLINE: This is a pilot, multicenter study.

      Patients undergo blood collection for blood typing (if not already obtained) and factor VIII
      and C-reactive protein levels at baseline. Patients are followed to obtain information on
      their Karnofsky performance status, treatment they receive for their brain tumor, and
      occurrence of any thrombotic events (e.g., pulmonary embolism or deep-vein thrombosis).
      Patients are followed every 28 days until the development of thrombotic events, after which
      they are followed every 2 months for survival.

      PROJECTED ACCRUAL: A total of 107 patients will be accrued for this study.
    

Intervention name(s): laboratory biomarker analysis; physiologic testing; management of therapy complications
Intervention type(s): Other; Other; Procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        outpatient clinic
      
Keywords: thromboembolism; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma