bioihbjkbjnl/mcl2 huggingface dataset:
Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease
Condition: Hypertension; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension
Study type: Interventional

Summary: 
      The purpose of this study to test whether n-of-1 trial-guided clinical decision-making
      improves blood pressure control in hypertensive children with chronic kidney disease (CKD)
      and end-stage renal disease (ESRD).
    


Intervention name(s): n-of-1 trial guided clinical decision making
Intervention type(s): Procedure
Intervention description(s): The n-of-1 trial will, on the level of the individual patient, test which treatment strategy produces superior blood pressure reduction without unacceptable side effects. After discussion with the patient/caregiver dyad to identify whether they have specific concerns about particular medications, the nephrologist (clinician) will decide which two drugs and dosages will be tested in the n-of-1 trial (the protocol does not determine drug or dose). The two drugs chosen by the clinician will be assessed at clinician-selected dosing in a randomized treatment order (e.g., ABAB) for two weeks per treatment period and two treatment periods per drug.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: n-of-1 trial
Watershift - Pilot Study
Condition: Total Body Water; Nocturnal Polyuria
MeSH terms: Polyuria
Study type: Interventional

Summary: 
      The aim of this pilot was to study how body water behaves between the different internal
      water pools of the human body, what the role and influence of the interstitium is and what
      the effect is of body position on the distribution and allocation of BW between different
      body parts (trunk, legs, arms). To study this, 2 techniques that have not been used before in
      urological research were tested on their usefulness:

        -  The first technique is a recent BIA device, which distinguishes itself from earlier
           devices by measuring impedance at different electrical currencies in different body
           parts (arm/limb/trunk). This technique made it possible to observe the influence of body
           position on the distribution of BW in these body compartments. Rationale for this
           research question is mainly the link between NP and edema that was found in earlier
           research and the fact that body position seemed to have an impact on the size of edema.
           For this reason, it can be suggested that body position and thus edema will have an
           impact on whether or not NP occurs.

        -  The second technique uses deuterium as a biological marker. With this technique the
           distribution, storage, allocation and excretion of BW was examined among the urological
           most relevant water pools (blood, urine and interstitium).
    


Intervention name(s): Bio Impedance assesement (BIA); Blood and salava sample; Ingestion of deuterated water; Urine sample
Intervention type(s): Diagnostic Test; Diagnostic Test; Dietary Supplement; Diagnostic Test
Intervention description(s): BIA every 5 minutes od the test protocol. Patients stood up for 5 minutes, laid down for 70 minutes, followed by 5 minutes in a seated position and ending with 30 minutes standing. BIA was done every 5 minutes.; Blood Samples were done at the initation of the protocol, and every 10 minutes after ingestion of the deutarated water; 15 minutes after the intiation of the test protocol, participants drink an amount of deuterated water corresponding with 0.25% of their TBW calculated using the Watson Formula; A urine sample is taken at the initiation and after termination of the protocol.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula
Condition: Perianal Fistula
MeSH terms: Rectal Fistula; Fistula
Study type: Observational

Summary: 
      This observational study aims at assessing the safety and efficacy profiles of mesenchymal
      stem cell, in different formats (SVF, autologous, allogenic), to treat complex perianal
      fistula according to the Spanish national Compassionate-use law .
    

Detailed description: 
      Under controlled circumstances, and approved by European and Spanish laws, a
      Compassionate-use Program allows the use of stem-cell therapy for patients with non-healing
      diseases, mostly complex fistula-in-ano, who do not meet criteria to be included in a
      clinical trial. Candidates had previously undergone multiple surgical interventions that had
      failed. The intervention consisted of surgery (with closure of the internal opening or a
      surgical flap performance), followed by stem cells injection. Three types of cells were used
      for implant: stromal vascular fraction, autologous expanded adipose-derived or allogenic
      adipose derived stem cells.

      Healing was evaluated at 6th month follow-up. Outcome was classified as partial response or
      healing. Relapse was evaluated 1 year later. Maximum follow up period was 48 months.
    

Intervention name(s): Mesenchymal Stem Cell injection
Intervention type(s): Procedure
Intervention description(s): curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We present an observational study, including 52 cases (53% male and 47% female) treated by
        a compassionate use ASC program. The mean age was 45 years and ranged from 24 to 69 years.
        There were 42 perianal fistulas, 7 rectovaginal fistulas, 1 urethrorectal fistula, 1 sacral
        fistula and 1 hidradenitis suppurativa. All the cases had previous failed surgeries.
        Thirteen of fifty-two (25%) of the cases presented fecal incontinence at the moment of
        enrollment. 5/52 (9,6%) of the cases presented anal stenosis and 11/52 (21%) had a scaring
        anus.
      
Keywords: Perianal fistula; compassionate use; mesenchymal stem cells
Multiple Ascending Dose Safety Study of ShK-186 (Dalazatide) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine safety outcomes in healthy volunteers after systemic
      administration of multiple ascending doses of dalazatide.
    

Detailed description: 
      The purpose of this study is to examine safety outcomes in healthy volunteers after systemic
      administration of multiple ascending doses of dalazatide delivered via subcutaneous injection
      twice per week for a total of 9 doses.
    

Intervention name(s): dalazatide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Different doses of drug, subcutaneous injection twice per week for a total of 9 doses.; Placebo delivered via subcutaneous administration twice per week for a total of 9 doses
Other intervention name(s): ShK-186; Sub Q Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: ShK-186; dalazatide; Kv1.3; SHK
Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep
Condition: Bowel Preparation
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep:
      2-sachets for oral solution in two divided doses given in the afternoon (first dose - sachet)
      and 6 hours later in the evening (second dose - sachet), given the day before the procedure
      or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the
      procedure to evaluate its effectiveness, tolerability and safety.
    


Intervention name(s): PicoPrep; HalfLytely; bisacodyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PicoPrep (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PicoPrep pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. Subjects randomized to the PicoPrep group will begin treatment (1st sachet) one day before colonoscopy between 4:00 and 6:00 PM, and will complete the treatment (2nd sachet) at least 6 hours later, between 10:00 PM and 12:00 AM. Subjects will consume approximately (5) 8 oz. glasses of clear liquids following the first sachet administration in the afternoon and (3) 8 oz. glasses of clear liquids following the second sachet administration in the evening, one day before colonoscopy.; HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed.; Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.
Other intervention name(s): PicoPrep™; Prepopik™
Intervention MeSH terms: Bisacodyl; Picosulfate sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bowel Preparation; Colonoscopy
Vascular Effect of Estradiol Valerate Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
Condition: Flow-mediated Dilation Evaluation of the Brachial Artery
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the vascular effects of estradiol valerate on
      climacteric women measured by flow-mediated evaluation of the brachial artery using high
      resolution ultrasound and compare to placebo.
    

Detailed description: 
      The interruption of the secretion of sex steroids that occurs after menopause, determines a
      change in vascular pattern at various levels. As a result, several side effects might appear
      and interfere with women's quality of life and health. The use of hormone replacement therapy
      has contributed to the improvement in these effects. It has been observed vascular beneficial
      effects of sex steroids in premenopausal women, and of hormone replacement therapy (HRT) in
      climacteric women, on the central retinal arteries. The objective of this study is to
      evaluate the effects of estradiol valerate on flow-mediated dilation of the brachial artery.
    

Intervention name(s): Estradiol valerate; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; Estradiol valerate
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to examine if inhaled doses of an e-cigarette flavor, alone and in combination
      with menthol, changes the appeal of e-cigarettes containing low and high doses of nicotine.
      The hypothesis is that menthol and the other experimental flavor will interact with nicotine
      dose to improve taste and liking for e-cigarettes.
    


Intervention name(s): Nicotine; Experimental Flavor; Menthol Flavor
Intervention type(s): Drug; Other; Other
Intervention description(s): Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml); Experimental fruit flavored e-cigarette for lab session; Menthol flavored e-cigarette for lab session
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Testicular Torsion
Condition: Testicular Torsion and TLR 4 Was Investigated
MeSH terms: Spermatic Cord Torsion
Study type: Interventional

Summary: 
      Background:

      Testicular torsion is a scrotal emergency that results in impaired blood supply to the testis
      and ischemia of the testis as a result of the rotation of the spermatic cord around itself.
      The etiology of testicular torsion is not clear, but various predisposing factors are
      responsible for the occurrence of testicular torsion.

      Recently, with the discovery of "Toll-Like Receptors" (TLRs), new horizons have been opened
      in the field of innate immune system-related diseases.

      Objective: To mediate the relationship between testicular torsion and TLR4 receptors.

      Material-Method: Testicular specimens of patients who developed testicular ischemia after
      testicular torsion and underwent orchiectomy between 2012-2022 were reached. A study of TLR 4
      receptors was performed in these testicular specimens. The patients were divided into two
      groups according to their ages newborns and adolescents.
    

Detailed description: 
      Analysis of 32 newborns and 32 adolescents between the ages of 14 and 16 (mean age was 15.17
      ± 0.98) testicular tissue lysate using Toll-Like Receptor antibody 4 (TLR4) ELISA
      (Enzyme-Linked ImmunoSorbent Assay).

      Toll-like receptor 4 is a transmembrane protein that in humans is encoded by the TLR4 gene.
      Its activation leads to the production of inflammatory cytokines.
    

Intervention name(s): Toll-like receptor 4
Intervention type(s): Genetic
Intervention description(s): Toll-like receptor 4
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: testicular torsion,; Toll-like receptors (TLR),; child; newborn; adolescent
Elonva in Combination With Hp-FSH Versus Elonva With Low Dose hCG
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The study compares in a randomized controlled way two stimulation methods. One of these
      stimulation methods implements a new insight in ovarian follicular growth. If this novel
      method of stimulation proves to be as efficient as the classical stimulation protocols, there
      might be a dramatic reduction of the costs of the medical therapy in IVF, thus reducing also
      the overall IVf costs significantly.
    


Intervention name(s): low dose hCG; hp-FSH; Corifollitropin Alfa
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Corifollitropin Alfa (Elonva) dosage depending on weight, once administered first day of ovarian stimulation for all subjects, and on day 7 they proceed with the treatment of the allocated group.
<60 kg: Elonva 100 MCG > 60 kg: Elonva 150 MCG
Other intervention name(s): Pregnyl; Menopur; Elonva
Intervention MeSH terms: Chorionic Gonadotropin; Menotropins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVF; ovarian stimulation; low dose hCG; hp-FSH; Corifollitropin Alfa; costs of IVF
Atlas Knee System Clinical System Clinical Study (USA)
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The primary objective of this pilot study is to collect data on the safety and effectiveness
      of the Atlas Knee System in subjects with medial knee osteoarthritis through 24 months
      postoperative follow-up.
    

Detailed description: 
      This study is designed as a prospective, multicenter, open-label, single arm, pilot study.
      Eligible subjects with symptomatic osteoarthritis of the medial compartment of the knee will
      be enrolled in the study and will receive the Atlas Knee Implant. The study population will
      consist of adult subjects age 25 to 80 years, with a diagnosis of medial knee osteoarthritis
      (Kellgen and Lawrence Grades 1-4, except those with bony erosions) and has pain in the study
      knee demonstrated as an overall WOMAC pain score of ≥ 40 (scale 0-100).
    

Intervention name(s): Atlas(TM) Knee System
Intervention type(s): Device
Intervention description(s): The Atlas System is an extra-capsular knee implant designed to unload the medial knee.
Other intervention name(s): Atlas System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-Term Safety and Efficacy Study of Peginterferon Beta-1a
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the long-term safety and tolerability of
      peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301
      (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this
      study is to describe long-term multiple sclerosis (MS) outcomes in participants originally
      treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.
    


Intervention name(s): peginterferon beta-1a
Intervention type(s): Drug
Intervention description(s): Administered as specified in the treatment arm
Other intervention name(s): PEGylated Interferon beta-1a; Plegridy; PEG IFN β-1a; BIIB017
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Subcutaneous; Extension; Interferon; MS; PEGylated; Injectable; SC; PEG; peginterferon beta-1a; Relapsing
Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye
Condition: Dry Eye; Sjogren's Syndrome; Aqueous Tear Deficiency; Meibomian Gland Dysfunction; Dry Eye Syndromes
MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction; Syndrome
Study type: Interventional

Summary: 
      The study aims to test the safety of Repetitive Magnetic Stimulation (RMS) treatment for dry
      eye disease. Patients are asked to undergo a one-time treatment with Epitech Ocular Magnetic
      Stimulation Device on one eye in the first stage and both eyes sequentially in the second
      stage of the study. Changes are monitored for over a study period of 3 months.
    


Intervention name(s): Ocular Repetitive Magnetic Stimulation (RMS) treatment
Intervention type(s): Device
Intervention description(s): First stage: Patients will be asked to undergo a one-time treatment with Epitech Corneal Magnetic Stimulation Device on one eye. The worst eye will be treated; if both eyes are equal, the right eye will be treated.
Second stage: will be treated on both eyes, applying treatment to both eyes sequentially during the same visit.
Intervention model: Single Group Assignment
Intervention model description: The study will include 30 patients enrolled in 2 stages.
The first 15 patients are treated in the more severe dry eye conditioned eye.
The remaining 15 patients will be treated on both eyes, applying treatment to both eyes sequentially during the same visit.
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Investigation of a Multinutrient Supplement on Skin Aging and Aging Metabolites in Healthy Women
Condition: Skin Diseases
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      We are seeking healthy female volunteers to determine if multinutrient supplementation
      affects visible signs of skin aging as well as blood measurements of aging. We are seeking
      smokers and non-smokers.
    

Detailed description: 
      Skin antioxidant levels as well as blood metabolites may change as the human body ages1,2.
      Although the chronological aging process is unstoppable, the physical signs of aging,
      particularly characteristics of the skin, may be delayed through a variety of medical
      interventions such as topical medications or resurfacing lasers. It is not currently known
      whether skin carotenoid antioxidant levels correlate with skin aging characteristics,
      although studies with other antioxidants suggest this may be true 3. In addition, while
      selected blood metabolites correlate with changes in age2, we do not know if this correlates
      with skin changes. Our current study focuses on whether differences in skin carotenoid levels
      and blood metabolite levels correlate with skin aging characteristics in age-matched
      subjects. Furthermore, we will explore whether three months consumption with a commercial
      multi-nutrient formulation (LifePak Nano) affects metabolic markers of aging, skin aging
      characteristics including skin elasticity and transepidermal water loss. We will also examine
      whether smokers respond differently from nonsmokers in the above parameters after
      supplementation.
    

Intervention name(s): Dietary Supplement: LifePak Nano
Intervention type(s): Drug
Intervention description(s): Daily use
Other intervention name(s): Life Pak Nano
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment