bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Pulse Rate Changes on Clinical Outcome
Condition: Overactive Bladder Syndrome; Chronic Urinary Retention
MeSH terms: Urinary Bladder, Overactive; Urinary Retention
Study type: Interventional

Summary: 
      Objectives: To evaluate the effect of pulse rate changes on the clinical response and
      stimulation related pain symptoms in sacral neuromodulation (SNM) treatment.

      Materials and Methods: This pilot study evaluated the effect of 4 different pulse rates
      (5.2Hz-10Hz-21Hz-40Hz) in patients with suboptimal response to SNM. The effect of each
      frequency was evaluated over test period of 6 days. To avoid carry over effect, stimulation
      was kept off for 24 hours between consecutive test periods. The last 3 days of every test
      period, a voiding diary (VD) and questionnaire was filled in. The changes on clinical
      response and pain symptoms were compared between the four pulse-rates using multivariate
      analysis.

      Results: Fifty patients were included of which 40 (80%) were female. Mean age was 55.5yr (SD
      12.3). Forty-one patients (82%) had overactive bladder symptoms and 9 (18%) had chronic
      non-obstructive urinary retention. No significant difference was found regarding clinical
      outcome (VD and questionnaire) between the different pulse rates. Furthermore, none of the
      four pulse rates was significantly related to the occurrence of SNM-related pain. However, on
      individual basis, patients appear to benefit from changing the pulse rate concerning both
      treatment efficacy and stimulation related pain.

      Conclusions: On group level, none of the four pulse rates in this study appears to have a
      significantly different effect on clinical outcome or SNM-related pain. However, a
      tailor-made approach for optimizing treatment efficacy by changing the pulse rate might be
      useful.
    


Intervention name(s): Pulse Rate Change
Intervention type(s): Other
Intervention description(s): Different pulse rate settings of the implantable neurostimulator
Intervention model: Single Group Assignment
Primary purpose: Treatment
The Effect of Fluid Management by Pleth Variability Index on Acute Kidney Injury in Obese Patients
Condition: Laparoscopic Colorectal Surgery; Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Interventional

Summary: 
      This study was to find out whether laparoscopic colorectal surgery is detrimental to the
      kidneys via PVI monitoring. To detect the kidney injury, so-called kidney troponin NGAL
      ,which gives earlier information than creatin in renal ischemic injury, was used.
    

Detailed description: 
      Our object in this study was to find out whether laparoscopic colorectal surgery is
      detrimental to the kidneys via PVI monitoring. To detect the kidney injury, so-called kidney
      troponin NGAL ,which gives earlier information than creatine in renal ischemic injury, was
      used.

      Patients undergoing elective laparoscopic colorectal surgery, 18 to 75 years old, planned
      surgery duration longer than 2 hours, were included in this study. Patients were divided into
      2 groups with respect to their fluid resuscitation, Group 1: goal directed fluid therapy via
      PVI monitoring Group 2: conventional fluid resuscitation. Blood samples were drawn from both
      groups for NGAL measurement before CO2 insufflation (T0), and at 6th(T1) and 12th(T2) hours
      after CO2 insufflation. At the end of the surgery, sugammadex was given to all patients for
      reversal of muscular blockade.
    

Intervention name(s): pulse variability index
Intervention type(s): Other
Intervention description(s): fluid management with pulse variability index or conventional
Other intervention name(s): conventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: NGAL; PVI
To Evaluate the Effect of Inhaled Medication Together With Exercise and Activity Training on Exercise Capacity and Daily Activities in Patients With Chronic Lung Disease With Obstruction of Airways
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of the study are to explore the effect of treatment with orally
      inhaled tiotropium + olodaterol fixed dose combination with and without exercise training,
      and tiotropium comparing to placebo, on top of behavioural modification in improving exercise
      capacity in patients with COPD
    


Intervention name(s): placebo to tiotropium + olodaterol; tiotropium+olodaterol; tiotropium +olodaterol; tiotropium
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): comparator; tiotropium 5 mcg once daily; olodaterol 5 mcg once daily fixed dose combination; tiotropium 5 mcg once daily fixed dose combination
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Study the Effect of Oral Zinc Supplementation on High Molecular Weight Zinc Binding Protein in Semen
Condition: Asthenozoospermia
MeSH terms: Asthenozoospermia
Study type: Observational

Summary: 
      There are several causes leading to male infertility, like oxidative stress, and nutritional
      deficiency of trace elements like zinc. Zinc in human seminal plasma was divided into three
      types of ligands which are high (HMW), intermediate (IMW), and low molecular weight ligands
      (LMW). The present study was conducted to study the effect of Zn supplementation on the
      quantitative and qualitative characteristics of semen along with Zinc Binding Protein levels
      in semen of patients with asthenozoospmia.
    

Detailed description: 
      Elevation of ROS levels lead to an increase the oxidation of HMW-Zn binding proteins in
      seminal plasma of asthenozoospermic subjects. Zinc supplementation restores HMW-Zn% in
      seminal plasma of asthenozoospermic subjects to normal value. LMW-Zn% is elevated in seminal
      plasma of asthenozoospermic patients. It may be because increment the levels of semenogelin
      in seminal plasma of asthenozoospermic subjects. Zinc supplementation elevates LMW-Zn% in
      seminal plasma of asthenozoospermic subjects to more than normal value, this may be because
      of its enhancement of the synthesis of metallothioneins (Low molecular weight zinc binding
      protein).
    

Intervention name(s): zinc sulfate
Intervention type(s): Dietary Supplement
Intervention description(s): every participant took two capsules of zinc sulfate per day for three months (each one 220mg)
Other intervention name(s): infertility
Intervention MeSH terms: Zinc Sulfate
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study includes 37 subfertile male partners from couples who had consulted the
        infertility clinic of the Babil hospital of maternity (Hilla city/ IRAQ).
      
Keywords: zinc binding protein
Electromyography in Patients on Chronic Pyridostigmine Therapy
Condition: Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      We intend to measure evoked EMG at two sites in subjects who are chronically taking
      pyridostigmine.
    

Detailed description: 
      The investigators are intending to enroll Patients who are chronically treated with
      pyridostigmine for the treatment of any medical condition and presenting at the
      investigators' outpatient clinics for follow up appointment. Subjects taking pyridostigmine
      for the treatment of myasthenia gravis will be excluded. Both adults and children older than
      12 years of age will be approached. Those subjects that agree to participate will be asked to
      sign an informed consent. For the participation of minors a parental (or guardian) consent
      and subject assent will be obtained. Those that participate will answer a few questions
      pertaining to their medical history and will then undergo electromyograph (CMAP) measurement
      with repetitive stimulation at 2 sites (ulnar nerve at the wrist and the accessory nerve in
      the neck). Evoked electromyogram will be recorded on a computer hard drive. Eight percent or
      greater decrement in the CMAP response on repetitive stimulation will be considered positive.
    

Intervention name(s): Electromyography (EMG)
Intervention type(s): Diagnostic Test
Intervention model: Single Group Assignment
Intervention model description: All subjects taking Pyridostigmine for at least 6mo, except for myasthenia gravis patients, will be considered for the study.Those that participate will answer a few questions pertaining to their medical history and will then undergo electromyography (CMAP) measurement with repetitive stimulation at 2 sites (ulnar nerve at the wrist and the accessory nerve in the neck). The first and fifth stimuli are delivered 2 seconds apart. Eight percent or greater decrement in the CMAP response on repetitive stimulation will be considered positive.
Masking: None (Open Label)
Primary purpose: Supportive Care
Empathy Levels Among Undergraduate Medical Students in Karachi, Pakistan - a Cross-sectional Study
Condition: Empathy
Study type: Observational

Summary: 
      Empathy is a concept native to the field of medicine. However, over the course of medical
      school, empathy levels are expected to decline. The aim of this study was to assess the
      empathy levels amongst medical students in relation to their year of study and specialties of
      choice in the future. A cross-sectional study was conducted to assess empathy levels among
      students from medical colleges in Karachi, Pakistan, using an online survey. The total
      duration of the study was two months. The authors analyzed the data using SPSS version 20. A
      total of 463 undergraduate medical students participated in this survey.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Undergraduate medical students enrolled in different years of the academic program were
        involved to cater to those in the pre-clinical years as well as those receiving clinical
        exposure.
      
Keywords: empathy; medical students; Pakistan; surveys and questionnaires; observational study
A Study to Determine the Safety and Attack Rate of the Seasonal Flu in Healthy Volunteers
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a non-controlled, open-label, single-centre, dose-escalation study to determine the
      safety, infectivity and immunology of the potential novel influenza virus H3N2 challenge
      strain. The term 'challenge agent' used in this protocol refers to the Influenza virus H3N2
      A/Belgium/4217/2015. The study utilises an adaptive study design and consists of 2 parts.
    

Detailed description: 
      In Part 1, the primary objective is to determine the viral challenge strain dose that has an
      acceptable safety profile and an observed attack rate of >60% (i.e., at least 8 out of 12
      subjects should be infected). After Part 1, a formal interim analysis will be performed to
      select the viral challenge strain dose for Part 2 by evaluating the primary objective of Part
      1. In case no viral challenge strain dose can be selected, the study will not proceed to Part
      2.

      In Part 2, the primary objective is to determine the infectivity rate in healthy volunteers
      of the selected viral challenge strain dose for use in subsequent human challenge
      intervention studies.

      All subjects will be screened prior to viral inoculation to assess their suitability to enter
      the study. Eligible subjects will be admitted to the clinical centre for a single intranasal
      inoculation with influenza A (H3N2). In this study, up to 64 healthy subjects will receive
      the investigational challenge agent: 36 subjects in Part 1 and 18 or 28 subjects in Part 2.
    

Intervention name(s): H3N2
Intervention type(s): Drug
Intervention model: Single Group Assignment
Intervention model description: single group
Masking: None (Open Label)
Primary purpose: Other
Impact of Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent
Condition: Malnutrition; Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Malnutrition; Iron Deficiencies
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety profile of oral iron supplementation
      (OIS) with Sprinkles in a pediatric population with high prevalence of Iron deficiency (ID)
      and moderate or severe malnutrition (MSM); the efficacy profile will also be investigated.
    

Detailed description: 
      Iron deficiency (ID) affects many children in developing countries. Anemia and impaired brain
      development are its most significant consequences. These may be prevented by giving oral iron
      supplements (OIS), such as Sprinkles. ID treatment was controversial because high dose
      parenteral iron therapy is strongly associated with severe infections when given to severely
      malnourished children. Many studies have since demonstrated the safety of low dose OIS. WHO
      guidelines reflect this finding: population-wide iron supplementation campaign (PWISC),
      without prior screening, is recommended when ID prevalence is ≥ 40%.

      However, a gap in the safety evidence has been identified: children with moderate or severe
      malnutrition (MSM) are strikingly absent from the studies performed to date to investigate
      the link between OIS and infectious morbidities. In this context, PWISC may have unrecognized
      deleterious effects when the prevalence of MSM is high, since safety is assumed, but
      incorrectly extrapolated from available evidence.

      We wish to emphasize an additional concern with regards to safety studies published thus far:
      all were designed as superiority trials. In this context, it is statistically incorrect to
      conclude that failure to show a significant difference between iron and placebo means that
      their respective side-effect profiles are similar.
    

Intervention name(s): Oral Iron Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Iron Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days; Placebo Sprinkles are provided as a powder in a single-dose sachet to be taken once daily for 60 days
Other intervention name(s): Sprinkles; Placebo Sprinkles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatrics; Malnutrition; Iron Deficiency; Sprinkles; Oral Iron Supplementation
A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to determine if ZS 10g administered up to three times over 10h added to
      insulin and glucose in patients presenting with hyperkalemia will prove tolerable and
      efficacious. Patients will receive ZS or Placebo on top of standard of care treatment with
      insulin and glucose.
    


Intervention name(s): Placebo; Sodium Zirconium Cyclosilicate(ZS); Insulin; Glucose; Insulin; Glucose
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Suspension administered orally for a treatment period of 24h. 2 sachets administered up to three times over 10h (at 0, 4 and 10h).; Suspension administered orally for a treatment period of 24h. Single dose contains 2 sachets of ZS 5g. 10g administered up to three times over 10h (at 0, 4 and 10h).; Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.; Glucose 25g administered IV <15 minutes before the insulin.; Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.; Glucose 25g administered IV <15 minutes before the insulin.
Other intervention name(s): ZS, ZS-9
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Two Fluid Strategies for Prevention of Post-dural Puncture Headache
Condition: Post-Dural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      Postdural puncture headache (PDPH) is a common complication after cesarean delivery (CD). The
      role of peri-operative fluid therapy in prophylaxis against PDPH is unclear. The aim of this
      work is to compare restrictive versus liberal fluid therapy in prophylaxis against PDPH after
      CD
    

Detailed description: 
      In this study, the investigators will compare restrictive fluid therapy and liberal fluid
      therapy in prophylaxis against postdural puncture headache.

      The restrictive group will not receive preoperative fluid loading, and will receive
      intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids
      at rate of 2 mL/Kg/hour for hours. The Liberal group will receive preoperative fluid loading
      of 5 mL/Kg, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour, followed
      by postoperative crystalloids at rate of 6 mL/Kg/hour.

      Both groups will be compared regarding demographic data, total peri-operative fluids,
      incidence of postdural puncture headache, nausea, vomiting, and intraoperative hemodynamics
      (heart rate and systolic blood pressure) in addition to neonatal outcomes.
    

Intervention name(s): Restrictive fluid therapy; Liberal fluid therapy
Intervention type(s): Drug; Drug
Intervention description(s): This group will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2 mL/Kg/hour.; This group will receive crystalloid preload of 5 mL/Kg, then will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 6 mL/Kg/hour.
Other intervention name(s): Restrictive fluids; Liberal fluids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Effects of a Group EMDR Intervention on Narrative Complexity and Specificity of Autobiographical Memories: the Hug the Child Study (HTC)
Condition: Child, Only; Narration; Memory Dysfunction; Distress, Emotional; Cognitive Change
Study type: Interventional

Summary: 
      Background and study aims:

      The Eye Movement Desensitization and Reprocessing Group Protocol with Children (EMDR-GP/C)
      was first developed by Korkmazlar following the Marmara earthquake in Turkey in 1999 and can
      be adapted for different populations. The aim of this study is to assess if a EMDR-GP program
      may help primary school students in improving narrative complexity and specificity of
      autobiographical memories, as well as their subjective unit of distress (SUD) and validity of
      cognition (VoC).

      Who can participate? Students attending the fourth or fifth year of primary school

      What does the study involve? Participants will be randomly assigned to the experimental and
      control groups. Participants in the experimental group will undergo a 3-week EMDR-GP with
      weekly 60-minute group sessions (3 sessions), while the control group will follow routine
      daily school activities.

      Questionnaires will be used to assess narrative complexity, specificity of autobiographical
      memories, SUD and VoC before and after the intervention.

      What are the possible benefits and risks of participating? Benefits of participating in the
      study may include an improvement of narrative complexity, specificity of autobiographical
      memories, and their SUD and VoC.
    


Intervention name(s): Group EMDR
Intervention type(s): Behavioral
Intervention description(s): The eight phases of the adapted group EMDR protocol was administered during each session: 1. Meeting: Explaining the nature of trauma, group rules, name tags, filling in the scales. 2. Preparation: Exploring children's support system, explaining EMDR, safe place, resource exercise, and installation with bilateral stimulation (BLS, butterfly hug or knee tapping). 3. Assessment: Drawing the worst image on a small separate sheet of paper, SUD level, (negative cognition, emotions, body sensations - if possible). 4. Desensitization: It is done with drawing on 4 separate papers with BLS (butterfly hug or knee tapping). 5. Installation: With the healing story written according to the adaptive information processing (AIP) model, the installation is accompanied BLS. 6. Body scan: A positive body state is installed with the relaxation technique. 7. Closure & future template: Strong closure with artwork. 8. Re-evaluation: if possible.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Child; EMDR; Narrative complexity; Autobiographical memories; Distress; Cognition
DAS181 for Severe COVID-19: Compassionate Use
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The objective of the study is to investigate the safety and potential efficacy of DAS181 for
      the treatment of severe COVID-19.
    

Detailed description: 
      Each eligible subject is treated with DAS181 for 10 days and observed for 28 days from the
      first day of administration.

      From day 1 to 10, once or twice a day, for 10 consecutive days, a total of 9 mg (7 ml)
      nebulized DAS181 is given. If DAS181 is given by twice a day, one vial containing 4.5 mg
      (3.5m1) DAS181 should be delivered with about 12-hour interval.
    

Intervention name(s): DAS181
Intervention type(s): Drug
Intervention description(s): Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; SARS-CoV-2; DAS181; Hypoxemia
Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study
      drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the
      efficacy and safety of CTA018 in the treatment of psoriasis. Patients with chronic plaque
      psoriasis will receive one of three doses of CTA018 cream or vehicle (no study drug) daily
      for 12 weeks.
    


Intervention name(s): CTA018 cream
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Psoriasis
A Phase 1 Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetics of a single oral dose of osilodrostat (LCI699) 30 mg in
      subjects with mild, moderate and severe hepatic impairment compared with subjects with normal
      hepatic function.
    


Intervention name(s): osilodrostat
Intervention type(s): Drug
Other intervention name(s): LCI699
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic impairment,; osilodrostat,; LCI699