bioihbjkbjnl/mcl2 huggingface dataset:
Dietary Protein and Hepatic Fat Accumulation
Condition: Hepatic Fat Accumulation; Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The objective of this study is to investigate the potential beneficial effect of increasing
      protein in the diet in order to decrease hepatic lipid accumulation on a high-fat diet.

      The investigators hypothesize that increasing protein in a high-fat diet suppresses lipid
      accumulation in the liver, and that changes in (hepatic) fat handling underlie this reduced
      lipid accumulation.
    


Intervention name(s): dietary protein; low-protein
Intervention type(s): Other; Other
Intervention description(s): in the low-protein group 13EN% of protein will be provided in the diet; in the high-protein 25EN% of protein will be provided; The control group will get a diet which is according to healthy eating guidelines.
Other intervention name(s): diet; diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Hepatic fat accumulation; Dietary protein; NAFLD
Perspective Analysis of Coronal Imbalance in Degenerative Scoliosis
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      Currently there is paucity of information on the prevalence of pre-operative coronal
      imbalance in patients with degenerative lumbar scoliosis (DLS) and its influence on surgical
      outcomes. This study aims to investigate in DLS, the prevalence of coronal imbalance, to
      propose a novel classification system and to investigate whether pre-operative coronal
      imbalance affects clinical outcomes following osteotomy. A total of 284 DLS patients were
      recruited.
    

Detailed description: 
      A total of 284 DLS patients were recruited into this two-stage study, among which 69 patients
      were treated by posterior-only correction and the remaining 215 patients received
      conservative treatment. Using pre-operative long-cassette X-ray films, all patients were
      classified based on coronal balance distance (CBD) defined as the horizontal distance between
      C7 plumb line and central sacral vertical line: Type A, CBD < 3cm; Type B, CBD > 3cm and C7PL
      shifts to the concave side of curve; Type C, CBD > 3cm and C7PL shifts to the convex side of
      curve. The prevalence of pre-operative coronal imbalance was calculated for stage I study.
      Post-operative CBD in patients who received surgery was measured to evaluate clinical
      outcomes for stage II study.
    

Intervention name(s): Posterior osteotomy correction
Intervention type(s): Procedure
Intervention description(s): The DLS patients underwent osteotomy including pedicle subtraction osteotomy (PSO) or Smith-Petersen osteotomy (SPO)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with degenerative scoliosis
Pediatric Resuscitation With Feedback CPR Devices
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      The aim of this study was to compare the TrueCPR feedback device (with metronome) to standard
      basic life support (BLS) in terms of the quality of single rescuer pediatric resuscitation.
      Therefore, our hypothesis was that there would be no difference between both CPR methods in
      terms of chest compression quality parameters.
    

Detailed description: 
      Cardiac arrest is a leading cause of death worldwide. High-quality chest compressions are of
      paramount importance for survival and good neurological outcome. Unfortunately, even health
      professionals have difficulty performing effective CPR. Chest compression (CC) is often too
      shallow, compression ratio is inadequate, and hands-off time is too long. CPR feedback
      devices might be an option for rescuers to in order to increase CC efficiency.
    

Intervention name(s): The TrueCPR feedback device; Standard BLS
Intervention type(s): Device; Device
Intervention description(s): feedback devices; Standard basic life support = chest compressions without any feedback device (manual resuscitation)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases
Condition: Breast Cancer
MeSH terms: Lymphatic Metastasis
Study type: Interventional

Summary: 
      The purpose of this research study is to determine how feasible and accurate identifying and
      removing specific lymph nodes in the axilla (armpit) after neoadjuvant systemic therapy is
      when patients present with breast cancer that has spread to lymph nodes in the axilla. The
      specific lymph nodes removed would be determined at the time of diagnosis. If a biopsy proves
      that cancer has spread to a lymph node, a titanium clip will placed in it to mark it for
      future removal. That lymph node will be removed after systemic therapy and compared with the
      rest of the lymph nodes removed from that region.
    


Intervention name(s): TAD
Intervention type(s): Procedure
Intervention description(s): the same intervention as listed in the arm description
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of Quetiapine in Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      This research study is being held at UCSD to determine whether the medication Quetiapine
      helps people suffering from anorexia nervosa by reducing core eating disorders symptoms. This
      study will see if the medication Quetiapine helps symptoms of anxiety, depression, and
      obsessionality, in addition to increasing BMI. Men and women between the ages of 18-65 and
      are currently suffering from anorexia nervosa are needed.
    


Intervention name(s): Quetiapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of Quetiapine (or placebo) will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.; Subjects will start with 25mg hs on day 1, 25mg bid on day 2, 25mg am and 50mg hs on day 3, 50mg bid on day 4, 50mg am and 75mg hs on day five, and 75mg bid on day six. Dosage will be increased further on an individual basis as determined by the study physician and as tolerated by the subject with a maximum dosage of 400 mg. Dose can be reduced as determined by clinical judgment. In order to determine the most effective dose, the dose of placebo will be titrated at intervals by staff according to the previously stated guidelines, the Pittsburgh Quetiapine Medication Management Assessment and Interview. Subjects will be interviewed about the factors described above and medication dose will be adjusted upward or downward depending upon symptom persistence or side effects.
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms
Condition: Vulvovaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind, placebo controlled Phase 2b study, divided in 2 parts:

        -  The main part of the study investigates the efficacy and safety of the Investigational
           Medicinal Product (IMP), intravaginally administered in glass syringes, on
           postmenopausal women with vulvovaginal atrophy symptoms.

        -  The exploratory part of the study investigates the efficacy and safety of the IMP,
           intravaginally administered in a laminate tube, on postmenopausal women with
           vulvovaginal atrophy symptoms.

      A comparison of plasma levels of oxytocin when the IMP is administered by 2 different
      applicators will be investigated in a sub-group of patients.

      In the main part, 160 subjects are enrolled and randomized to 2 different groups; 80 subjects
      receiving IMP and 80 subjects receiving placebo, in glass syringes. In the exploratory part
      of the study, 40 patients will be enrolled and randomized to 2 different groups; 30 subjects
      receiving IMP and 10 patients receiving placebo, in laminate tubes.

      The study is conducted at 3 sites in Sweden, and comprises 5 visits: screening visit (Visit
      0), randomization visit (Visit 1; Day 0), treatment follow-up visit (Visit 2; Week 4), end of
      treatment visit (Visit 3; Week 12) and a telephone follow-up visit (Visit 4; Week 14). All
      patients self-administer the IMP once daily for 12 weeks.
    


Intervention name(s): Oxytocin 400 IU vaginal gel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo gel with identical appearance to the test product, used as reference treatment.
Other intervention name(s): Vagitocin; Placebo (for Vagitocin)
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Plyometric Training Isometric Strength Training on Quadriceps Strength and Functional Performance.
Condition: Football Players
Study type: Interventional

Summary: 
      This study aims to investigate the influence of an eight-week plyometric and quadriceps
      strength training program on muscular strength, sprint, and functional performance in
      collegiate football players.
    

Detailed description: 
      Sixty collegiate football players aged 18-25 years were recruited, at the university campus.
      All of them were randomly divided into two experimental and control groups that participated
      in training for six weeks on alternate days (i.e., three sessions per week), and one control
      group (n=30) did not train. The control group was instructed to maintain regular activities
      and avoid any strenuous physical activity during the study.

      Under the Declaration of Helsinki, participants were informed about the study's possible
      risks and benefits, and all participants signed informed consent before participation in the
      study. The ethical sub-committee of the College of applied medical science, Majmaah, Saudi
      Arabia approved this study (Ethics Number: MUREC-Jan. 25/COM-2021 / 19-5).
    

Intervention name(s): Isometric strength training for 8 week; Conventional training
Intervention type(s): Other; Other
Intervention description(s): Plyometric training for 8 week; Conventional training for 8 week
Other intervention name(s): plyometric training training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Strength Resisted sprint training; Plyometric training; Function performance; Resisted sprint training
PGL4001 Versus Placebo in Uterine Myomas
Condition: Uterine Myomas
MeSH terms: Myoma; Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will assess the efficacy and safety of PGL4001 with concomitant iron
      administration versus placebo with concomitant iron administration, over a 3-month period for
      the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding
      due to uterine myoma.
    


Intervention name(s): PGL4001 (ulipristal) and iron; PGL4001 matching placebo and iron; PGL4001 (ulipristal) and iron
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablets; tablets; Tablets
Other intervention name(s): Ulipristal acetate; Placebo of ulipristal; Ulipristal acetate
Intervention MeSH terms: Iron; Ulipristal acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of Intraperitonael Nebulization of Local Anesthetic on Postoperative Pain Associated With Laparoscopic Surgery
Condition: Gynecologic Laparoscopic Surgery
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Studies evaluating intraperitoneal local anesthetic instillation for pain relief after
      laparoscopic procedures have provided conflicting results. This randomized, double-blind
      study was designed to assess the effects of a novel intraperitoneal local anesthetic
      administration technique using nebulization on pain relief after gynecologic laparoscopic
      surgery.
    

Detailed description: 
      Studies evaluating intraperitoneal local anesthetic (LA) instillation for pain relief after
      laparoscopic surgery have provided conflicting results. One of the factors that might
      contribute to failure of the instillation technique may be related to inadequate distribution
      of local anesthetic throughout the peritoneal surface. In contrast, nebulization should
      provide a uniform spread of drugs throughout the peritoneal cavity and thus may be beneficial
      to improve pain relief after laparoscopic procedures. The investigators reported that a
      microvibration-based nebulization device (Aeroneb Pro® system, Aerogen, Galway, Ireland)
      could be used for ropivacaine delivery into the insufflation gas required to create
      pneumorpeitoneum. The investigators hypothesized that intraperitoneal ropivacaine
      nebulization would provide superior pain relief than ropivacaine instillation after
      gynecologic laparoscopic surgery. This randomized, double blind, controlled clinical trial
      was designed to assess the analgesic efficacy of ropivacaine nebulization before or after
      surgery compared with intraperitoneal ropivacaine instillation and placebo after gynecologic
      laparoscopic procedures.
    

Intervention name(s): Ropivacaine 30 mg; Ropivacaine 30 mg; Ropivacaine 100 mg; saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): preoperative instillation of saline 20 ml, nebulization of ropivacaine 1% 3 ml (30 mg) before surgery and nebulization of saline 3 ml after surgery; preoperative instillation of saline 20 ml, preoperative nebulization of saline 3 ml and nebulization of ropivacaine 1% 3 ml (30 mg) after surgery; preoperative instillation of ropivacaine 0,5% 20 ml (100 mg) and nebulization of saline 3 ml before and after surgery; preoperative instillation of saline 20 ml and nebulization of saline before and after surgery
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gynecologic laparoscopic surgery; Postoperative pain; Nebulization; Ropivacaine
Bioequivalence of Topical Acyclovir in Healthy Volunteers
Condition: Dermatologic Disorders
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      The overall aim of this clinical study is to investigate the ability of dermal open flow
      microperfusion to assess bioequivalence and non-bioequivalence of acyclovir formulations in
      the skin of healthy volunteers.
    

Detailed description: 
      This will be a single center, open label, exploratory research study to evaluate the BE of
      already marketed formulations of acyclovir in dermal interstitial fluid (ISF) in healthy
      volunteers using dOFM. The study will be conducted at the Clinical Research Center at the
      Medical University Graz. dOFM represents the most reliable way to sample interstitial fluid
      from skin, since it provides diluted but otherwise unchanged dermal interstitial fluid. To
      assess BE and non-BE, we have designed the experiments in such a way that each subject can
      serve as its own control. Each subject will have two sets of BE and non-BE pairs in parallel.
      This study is designed to test dOFM, a new sampling method that allows measurement of skin
      penetration. Measurement of skin penetration enables the reduction of the impact of
      inter-subject variability and therefore decreases the number of subjects needed to achieve
      statistical significance.
    

Intervention name(s): 5% Zovirax® cream; 5% Aciclostad cream; 5% Aciclovir cream 1A Pharma; 5% Zovirax Cold Sore Cream; 5% Zovirax® cream (Austria); OFM; OFM Probe; OFM Pump
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure; Device; Device
Intervention description(s): (manufactured by GlaxoSmithKline Pharma in Canada, distributed in the USA by Valeant Pharmaceuticals North America LCC, Bridgewater,NJ 08807); (STADA Arzneimittel GmbH, Vienna, Austria); (1A Pharma GmbH, Vienna, Austria); (GlaxoSmithKline Consumer Health Care, Brendfort, UK; Marketing authorization holder: Beeham Group PLC, Brendfort, UK); (GlaxoSmithKline Pharma GmbH, Vienna, Austria); Sampling method for interstitial fluid; Sampling probe used during OFM; Pump used to operate OFM probes
Other intervention name(s): Aciclovir; Aciclovir; Aciclovir; Aciclovir; Aciclovir; Open Flow Microperfusion; 'DEA15003' (linear type, 0.5mm OD, 15mm open mesh); 'MPP102' (wearable, operates 3 to 6 probes)
Intervention MeSH terms: Acyclovir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Open Flow Microperfusion
Failure of Vaginal Delivery After Induction
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will compare the number of women who deliver vaginally after artificial initiation
      of labor pains(i.e. induction of labor) by two methods. Half of the women would receive
      tablet misoprostol vaginally and the other half would receive tablet misoprostol and foley's
      balloon catheter both.
    

Detailed description: 
      Artificial initiation of labor pains has become a common occurrence. A variety of methods are
      employed to initiate labor pains. Labor pains are more successful in culminating into vaginal
      delivery if the neck of womb that is the cervix is soft (ripe). This is usually achieved by
      ripening agents. They include drugs and devices that help soften the cervix. Misoprostol and
      foley's balloon catheter both are used to soften the cervix so that vaginal delivery is
      possible. Both work on different aspects of the softening of cervix.

      Misoprostol acts on shortening the cervix and making it more pliable Foley's balloon helps to
      open up the cervix that is it aids in dilating the cervical canal.
    

Intervention name(s): Misoprostol; foley's balloon catheter
Intervention type(s): Drug; Device
Intervention description(s): Women would be given misoprostol tablet by mouth; foley's balloon catheter would be inserted through vagina into cervix.
Other intervention name(s): cytotec; foley's catheter
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: induction of labor; misoprostol; foley's balloon catheter
Pilot Study of Gleevec/Imatinib Mesylate (STI-571, NSC 716051) in Neurofibromatosis (NF1) Patient With Plexiform Neurofibromas
Condition: Neurofibromatosis; Neurofibromas
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Neurofibroma, Plexiform
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a second Pilot Study to determine the efficacy of Gleevec® in neurofibromatosis (NF1)
      patients with plexiform neurofibromas using new response assessment modalities with the
      secondary goals of assessing Gleevec toxicity, and characterizing markers of response. The
      rationale for this study arises from the response of human and murine NF1 cells to Gleevec®
      in vitro, the response of a NF1 patient treated with Gleevec® for airway compression by a
      plexiform neurofibroma with a dramatic response not previously seen in NF1 therapy, and the
      experience in 37 NF1 patients treated with Gleevec® in the initial pilot study. Gleevec will
      be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2
      or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the
      dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum
      dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of
      55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid. Treatment
      will continue for 6 months with an option to continue for 24 months if the patient is
      deriving a clinical benefit.
    


Intervention name(s): Gleevec
Intervention type(s): Drug
Intervention description(s): Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
Other intervention name(s): Imatinib Mesylate
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurofibromas
A Study to Evaluate the Efficacy and Safety of Eplerenone in the Treatment of Hypertension in Children.
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy, safety, and toleration of eplerenone in the treatment of children
      aged 6 to 16 years with high blood pressure. The study will last approximately 10 weeks and
      about 320 patients will participate.
    


Intervention name(s): Eplerenone
Intervention type(s): Drug
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment