bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Niacin in the Lipoprotein (a) Concentration
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives.

        -  To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg
           day of Niacin/Laropiprant in subjects with normal Lp(a) (< 30 mg/dL), high Lp(a) (30-60
           mg/dL) and very high Lp(a) (> 60 mg/dL).

        -  To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg
           day of Niacin/Laropiprant depending on the number of kringle IV-2 repeated copies on the
           apo(a) gene. 2.1.1 Hypotheses.

        -  The Lp(a) lowering effect of niacin is dependent of the pre-treatment Lp(a)
           concentration, with higher absolute and relative reduction in Lp(a) in subjects with
           hyperlipoproteinemia(a).

        -  Lp(a) size, throughout modifying hepatic synthesis of apo(a), is a major factor related
           to the lowering effect variability of niacin in human.
    

Detailed description: 
      Open-label 12-week study, 1g/20 mg day of Niacin/Laropiprant for 4-weeks followed by 8
      additional weeks of 2 g/40 mg day. Subjects with normal Lp(a) will be use as comparative
      group for the other two groups, so no placebo group is required is this study.

      Subjects: volunteers from the Lipid Clinic of Hospital Universitario Miguel Servet of
      Zaragoza, Spain. Subjects were selected according to their previously determined
      Lp(a)concentration. All volunteers before any study procedure will have to give written
      inform consent to a protocol previously approved for the Ethical Committees of our
      institutions.

      Biochemical determinations: lipids: total cholesterol and triglycerides; lipoproteins:
      HDL-cholesterol, Lp(a); apolipoproteins: Apo A1 and apo B and safety biochemical parameters
      (glucose, uric acid, creatinine, liver and muscle enzymes will be measured at baseline and at
      the end of the two treatment periods (weeks 4 and 8).

      An adverse experience questionnaire will be done in each visit. Genetic analysis: apo(a)
      genetic polymorphism responsible of the Lp(a) size variability will be analyzed by a
      PCR-based methodology (Lanktree et al. J Lipid Res 2009; 50: 768-72 ).
    

Intervention name(s): Niacin/Laropiprant
Intervention type(s): Drug
Intervention description(s): 1g/20 mg day of Niacin/Laropiprant for 4-weeks followed by 8 additional weeks of 2 g/40 mg day.
Intervention MeSH terms: Niacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lipoprotein (a); LPA; Niacin; Kringle IV-2 repeats
A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      Female inability to conceive a child. The purpose of this randomized, two-arm and double
      blind, double dummy study is to demonstrate that the treatment of a daily dose of 3x10mg
      dydrogesterone orally is as effective and safe as the daily dose of 3x200 mg micronized
      progesterone capsules administered intravaginally for the luteal support in patients
      undergoing IVF. The treatment will start on the day of oocyte retrieval and continue until
      pregnancy is negative or until week 12 gestation.Patients will be followed after treatment
      until 30 days after delivery to record any safety and tolerability data of the patient and
      their newborn(s).
    


Intervention name(s): Dydrogesterone 30 mg; Micronized Progesterone 600 mg; Placebo progesterone; Placebo dydrogesterone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral Dydrogesterone 10 mg tablets tid; Intravaginal micronized progesterone 200 mg capsules tid; Placebo intravaginal micronized progesterone 200 mg capsules tid; placebo oral dydrogesterone 10 mg tablets tid
Intervention MeSH terms: Progesterone; Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose is to study efficacy of Lactofiltrum in adult patients with atopic dermatitis.
      Lactofiltrum consists of 85% of hidrolytic lignin and 15% of lactulose and acts as an
      enterosorbent, which enables to enhance metabolism and elimination of endotoxins and to
      normalize metabolic and immune processes. Additionally, lactulose stimulates Bifidobacterium
      flora and in aggregate it could improve skin condition afflicted by atopic dermatitis.
    


Intervention name(s): Lactofiltrum; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days; Placebo 2 tablets 3 times a day before meals during 21 days
Other intervention name(s): Lactulose; Lignin
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lactofiltrum; atopic dermatitis; itching; Dermatological Index of Life Quality; SCORAD; Behavioral Rating Scores
Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis
Condition: Ulcerative Colitis; Primary Sclerosing Cholangitis; Pouchitis; Complications
MeSH terms: Colitis; Colitis, Ulcerative; Cholangitis; Cholangitis, Sclerosing; Pouchitis; Ulcer
Study type: Observational

Summary: 
      Primary sclerosing cholangitis (PSC) occurs in approximately 10 % of patients with ulcerative
      colitis (UC), but the outcome of reconstructive surgery is not clear. The purpose of this
      study was to determine the functional outcome after surgery, frequency of pouchitis,
      complications and failure-rate in UC-PSC patients compared to patients with UC alone. Both
      ileal pouch-anal anastomosis (IPAA) and ileo-rectal anastomosis (IRA) were studied.
    

Detailed description: 
      Primary sclerosing cholangitis (PSC) is characterised by inflammation and fibrosis of the
      biliary tree and the condition can lead to end-stage liver disease. PSC is strongly
      associated with inflammatory bowel disease (IBD), with a prevalence of IBD in PSC as high as
      60-84 % in Northern Europe and North America. The majority of patients with IBD and PSC have
      ulcerative colitis (UC).

      Considering all patients with UC, around 30% will ultimately require surgery; the most common
      indications are acute colitis, chronic refractory disease or colorectal dysplasia. The
      standard procedure is proctocolectomy and ileal pouch-anal anastomosis (IPAA). However,
      ileo-rectal anastomosis (IRA) or conventional ileostomy are options. The prognosis after
      surgery is generally considered good.

      Previous studies have shown that the course of colitis in patients with UC/PSC is different
      from that of patients with UC-only.

      In a patient with UC, several aspects have to be considered at counselling before surgery.
      However, in many aspects, the literature is substantial for patients with UC-only (for
      example function and quality of life after IPAA) and key information can be safely provided.
      Conversely, patients with UC/PSC that require colectomy are rare and as a consequence, data
      on most aspects is sparse (18-20).

      The aim of the study was to assess outcome after surgery (IPAA or IRA) in patients with
      UC/PSC. Focus was on pouch/rectal function, pouchitis, surgical complications and failure.
      Patients with UC-only were employed as controls.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with UC/PSC vs patients with UC only reconstructed surgically with IPAA or IRA.
      
Keywords: Ulcerative Colitis; Primary Sclerosing Cholangitis; Ileal pouch-anal anastomosis; Ileorectal anastomosis; Surgical outcome; Functional outcome; Failure
Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis
Condition: Arthritis, Septic
MeSH terms: Arthritis, Infectious; Arthritis
Study type: Interventional

Summary: 
      The optimal duration of systemic antibiotic administration for native joint septic arthritis
      is unknown. The investigators perform a randomized study allowing up to 3 surgical lavages
      and allocating patients into a two-week's and a four week's randomization arm
    

Detailed description: 
      The optimal duration of systemic antibiotic administration for native joint septic arthritis
      is unknown. The investigators perform a randomized study allocating patients into a
      two-week's and a four week's randomization arm.

      The adult patients are hospitalized for septic arthritis. A computer program randomizes 1:1
      between a two week's and a four week's arm of targeted antibiotic treatment of which at least
      the first week is intravenously. The randomization may occur until Day 5 of admission. Up to
      three surgical interventions are allowed. The investigators allow the inclusion of all
      bacterial arthritis and all joints.
    

Intervention name(s): Two week's arm - surgery; Four week's arm - surgery; Two week's arm - drugs; Four week's arm - drugs
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.; The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.; After the surgical implant removal, the investigators prescribe a total of 2 weeks of systemic targeted antibiotic therapy against the causative pathogen(s), of which one week is recommended to be intravenously.; After the surgical implant removal, the investigators prescribe a total of 4 weeks of systemic targeted antibiotic therapy against the causative pathogen(s), of which one week is recommended to be intravenously.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: septic arthritis; surgery; antibiotic duration; remission; sequelae
Tricuspid Regurgitation Study
Condition: Tricuspid Regurgitation; Right Ventricular Dysfunction; Left Ventricular Dysfunction
MeSH terms: Ventricular Dysfunction; Tricuspid Valve Insufficiency; Ventricular Dysfunction, Left; Ventricular Dysfunction, Right
Study type: Interventional
Phase: Phase 4

Summary: 
      The effect of cardiac pacing leads on tricuspid regurgitation is unclear. This study will
      determine whether using a smaller diameter leads and an alternate position in the ventricle,
      the proximal septum, will reduce tricuspid regurgitation than larger leads placed in the
      apex.
    

Detailed description: 
      Leads are commonly placed in the right ventricular apex. It is not known whether placing
      similar leads higher on the septum where there will be less redundancy or pressure on the
      septal leaflet will change the extent and severity of tricuspid regurgitation following
      pacemaker/ICD implantation. Data has shown that right ventricular pacing can give rise to
      right ventricular dysfunction, which in turn may give rise to enlargement of the right
      ventricle and cause tricuspid regurgitation.

      The study will answer the clinically relevant questions on device lead-related tricuspid
      regurgitation.

      This study is a single center prospective study at the Mayo Clinic, Rochester. The study will
      enroll 200 eligible subjects and follow for 12 months. 50 pacemaker subjects will be
      randomized to right ventricular apex pacing 50 pacemaker subjects will be randomized to right
      ventricular septum pacing 50 pacemaker subjects will be randomized to left ventricular pacing
      via coronary sinus 50 ICD subjects will be enrolled with right ventricular apex pacing.

      A baseline heart failure assessment and Two Dimensional echocardiography will be performed
      before device implant.

      A Two Dimensional echo will be performed 24 hours after device implant. If significance TR is
      present a Three Dimensional echo will be performed. At 12 months post implant heart failure
      assessment and Two Dimensional echo will be performed.
    

Intervention name(s): Echo; Echo; Echo; Echo
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.; Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation; Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.; Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
Other intervention name(s): Medtronic Starfix lead
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Reduce Tricuspid Regurgitation; Reduce Right Ventricular pacing; Lead position; Lead size
Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery
Condition: Cardiac Disease; Cardiac Failure; Cardiac Surgery; Inotropes; Ejection Fraction
MeSH terms: Heart Diseases; Heart Failure
Study type: Interventional

Summary: 
      The aim of this retrospective study will be to investigate the effect of the preoperative
      administration of levosimendan on the outcome of patients with compromised cardiac function
      undergoing cardiac surgery
    

Detailed description: 
      Patients with severely reduced left ventricular ejection fraction (LVEF) face a high risk of
      morbidity and mortality after cardiac surgery. Impaired cardiac function preoperatively
      predisposes patients to low cardiac output syndrome. Levosimendan acts by a different
      mechanism than traditional inotropes and its preoperative use could improve the outcome of
      patients with cardiac failure. Specifically, it promotes vasodilation of coronary, pulmonary
      and systemic vessels, has an anti-inflammatory and anti-oxidant effect and enhances cardiac
      contractility by improving the response of the myofilaments to intracellular calcium.

      The aim of this retrospective study will be to investigate the effect of the preoperative
      administration of levosimendan on the outcome of patients with compromised cardiac function
      undergoing cardiac surgery.
    

Intervention name(s): preoperative infusion of levosimendan; no preoperative infusion of levosimendan
Intervention type(s): Procedure; Procedure
Intervention description(s): the study group will consist of patients who have received a continuous infusion of levosimendan 0.1 μg/kg/min for 24 hours before cardiac surgery; the control group will consist of patients who proceeded to the cardiac operation without any infusion for 24 hours preoperatively
Intervention MeSH terms: Simendan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Retrospective
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: levosimendan; low output syndrome
Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in
      drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin and
      simvastatin in healthy male and female subjects.
    

Detailed description: 
      This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in
      drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin, and
      simvastatin in healthy male and female subjects. Thirty-four (34) subjects will be enrolled
      in Part 1 (rosuvastatin) and based on review of the PK and safety/tolerability data, a
      decision will be made on whether to proceed with Part 2. Part 2 consists of 2 arms
      (sulfasalazine and pravastatin). Twenty-six (26) subjects will be enrolled into each arm.
      Part 3 consists of 2 arms (atorvastatin and simvastatin). Twenty-four (24) subjects will be
      enrolled into each arm after enrollment in Part 2 is completed. Subjects will be in the study
      for up to 72 days, including a 28-day screening period, 6-14 day in clinic period, and a
      30-day follow up period post last dose. Blood samples for PK analysis will be collected at
      pre-defined time points throughout the study.
    

Intervention name(s): Vadadustat; Simvastatin; Rosuvastatin; Atorvastatin; Pravastatin; Sulfasalazine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral dose of 600 mg QD; Oral Simvastatin; Oral Rosuvastatin; Oral Atorvastatin; Oral Pravastatin; Oral Sulfasalazine
Other intervention name(s): AKB 6548
Intervention MeSH terms: Sulfasalazine; Atorvastatin; Rosuvastatin Calcium; Simvastatin; Pravastatin
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a three-part sequential design study. Part 2 will be initiated based upon the outcome of Part 1 and Part 3 will be initiated after completion of Part 2.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vadadustat; Normal Healthy volunteers; Pharmacokinetics; Rosuvastatin; Sulfasalazine; Pravastatin; Atrovastatin; Simvastatin
The Effect of Foot Reflexology on Infantile Colic Symptoms
Condition: Infantile Colic; Reflexology
MeSH terms: Colic
Study type: Interventional

Summary: 
      Aim: To compare the effect of foot reflexology and placebo foot reflexology on colic symptoms
      such as pain, ineffective sleep, and colicky crying periods in infants with colic.

      Method: The study was conducted as a single-blind, randomized, placebo-controlled trial in a
      child hospital between June 2016 and March 2017. To start with, 20 infants with colic were
      randomly selected for the reflexology group, and 25 babies with colic were randomly selected
      for the placebo group. Simple randomization was used; the parents and statistician were
      blinded to group assessment. The researcher could not be blinded because of the role played
      in the study. Foot reflexology was implemented with reflexology-group infants. Placebo foot
      reflexology was used with placebo-group infants. Both interventions were performed four
      times, for 20 minutes, each, by the researcher over the course of two weeks. The data were
      collected by the researcher using the information form, infantile colic scale, behavioral
      pain scale, crying and sleeping follow-up forms.
    


Intervention name(s): Foot Reflexology; Placebo Foot Reflexology
Intervention type(s): Other; Other
Intervention description(s): Reflexology is one of the complementary health approaches; it is based on systematic pressure and stimulation with fingers to energy points in feet and hands and is a topic nowadays studied. Reflexology argues that the reflex maps in the hands and feet with all of the parts of the body are in contact. The pressure applied to each point stimulates the circulation of blood and energy like a sensor, gives a sense of relaxation, provides homeostasis. With a touch that is a different way of communication with children, is supported to create physical awareness via reflexology techniques, and is provided healthy nutrition of the stimulated tissue.; Placebo reflexology was performed by touch without pressure to the same rotation and to the same points as foot reflexology application. It was performed only to compare foot reflexology with a placebo effect.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was an experimental, single-blind, randomized, placebo-controlled trial.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: complementary therapies; infantile colic; nurses; reflexology
Predicting Rupture of AAA by Anatomic and Hemodynamic Markers
Condition: Aortic Aneurysm, Abdominal
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Rupture
Study type: Observational

Summary: 
      The purpose of the study is to investigate imaging findings, which can help us to predict
      factors contributing to abdominal aortic aneurysm growth and rupture.
    


Intervention name(s): Medical imaging
Intervention type(s): Other
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary and specialty care clinics and emergency room visits.
Pre-Op Sildosine and Ureteral Dilation During F-URS
Condition: FURS; Ureteral Dilatation; Sildosine
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      We proposed that silodosin administration preoperatively may facilitate ureteral access
      sheath (UAS) placement prior to flexible ureteroscopy (F-URS) and decrease the incidence of
      ureteric injury in some difficult cases.
    

Detailed description: 
      Urolithiasis is a common urological disorder in the world and has a significant effect on the
      global health system. The goal of treatment is to achieve the highest stone-free rate (SFR)
      with the least invasive. Per¬cutaneous nephrolithotomy and flexible ureterorenoscopy (F-URS)
      are the two main minimally invasive procedures for the treatment of upper urinary tract
      stones.

      The challenging step in flexible ureterorenoscopy (F-URS) is ureteroscopic access sheath
      (UAS) placement, which facilitates fast and safe access to the ureter and collecting system;
      improves visibility; reduces the risk of infection by reducing intrarenal pressure. However,
      in some cases, the acute ureteric injury may occur during ureteroscopic access sheath (UAS)
      placement.
    

Intervention name(s): Sildosin group; Placebo/control group
Intervention type(s): Drug; Procedure
Intervention description(s): Patients in this group had flexible ureteroscopy (F-URS) with preoperative daily uptake of 8 mg silodosin for one week.; included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment