bioihbjkbjnl/mcl2 huggingface dataset:
Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
Condition: Feeling Anxious
Study type: Interventional
Phase: Phase 2

Summary: 
      The insertion of long-lasting intravenous device is done under local anesthesia. Currently,
      in the investigators hospital, no premedication is given to the patients. However, this
      procedure occurs in a particular emotional context related to the diagnosis of cancer or
      malign hemopathies.

      Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure
      can be questionable.

      Hydroxyzine is the reference molecule for premedication because of its anxiolytic and
      anti-histaminic properties A new agent, pregabalin, shares also the same properties

      The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on
      the anxiety score as a premedication during the insertion of long-lasting intravenous device
      under local anesthesia.
    


Intervention name(s): hydroxyzine; Pregabalin; Lactose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 75 mg; 150 mg; 4 g
Intervention MeSH terms: Pregabalin; Hydroxyzine
Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery
Condition: Obstetric Anal Sphincter Injury; Vaginal Electrical Stimulation
Study type: Interventional

Summary: 
      For too many women, childbirth results in devastating consequences: involuntary loss of feces
      or urine (fecal or urinary incontinence). In fact, up to 50 percent of women with severe
      tears during childbirth may develop these problems. These new mothers avoid leaving home in
      order to stay close to a toilet, wear protective pads every day, and avoid activities they
      previously enjoyed such as exercise and sexual intercourse. It is not surprising that many of
      these women suffer from postpartum depression, and bonding with their newborns is
      compromised.

      Fecal and urinary incontinence occur due to injuries to the pelvic nerves and muscles during
      childbirth. Many researchers have focused on what can be done to prevent these injuries;
      however, few have investigated how to help the countless women who have already suffered from
      these injuries to the nerves and muscles. In other fields such as orthopedics and neurology,
      research shows that electrical stimulation can provoke nerve regeneration after injury.
      Applying this technology to women who have recently suffered from nerve injury during
      childbirth could have profound and life-changing effects. Investigators hypothesize that
      electrical stimulation immediately postpartum will markedly help pelvic nerves regenerate,
      minimizing rates of fecal and urinary incontinence for this vulnerable population of new
      mothers.
    


Intervention name(s): ApexM (Stimulation) Device; Sham Device
Intervention type(s): Device; Device
Intervention description(s): Vaginal electrical stimulation will be administered via the Apex M Device. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Stimulation session will last 10 minutes and occur 6 times per week for a total of 12 weeks.; A sham Apex M device without electrical stimulation will be used. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Each session will last 10 minutes and occur 6 times per week for a total of 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Apex M; Postpartum; Pelvic Floor rehabilitation
Effects of Trigger Point Dry Needling in Individuals With Patello Femoral Pain Syndrome : A Randomized Controlled Trial
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      A double blinded clinical controlled trial will be performed on individuals with patello
      femoral pain syndrome in which Trigger Point Dry Needling will be given to experimental group
      while Sham Needling will be given to the control group, targeting the trigger points present
      in the Quadriceps of affected individuals assessing the pain,functional disability and range
      of motion of the affected individuals.
    

Detailed description: 
      A double blinded Randomized Controlled Trial of 6 months study after the approval of
      synopsis, will be conducted. Convenience sampling technique will be used to enroll the
      patients. Patients will be selected according to predefined inclusion and exclusion criteria.
      All patients who fulfill inclusion criteria will be allocated in two group through
      randomization by lottery method. Group A will receive TrP-DN and group B will receive Sham
      Needling. Both groups will be asked to perform stretching exercise of Quadriceps daily after
      needling. The patients' outcomes will be measured by VAS for pain intensity and Kujala
      Questionnaire for functional status. The comparison between pre-treatment and post-treatment
      data will be done after 3 months. Informed consents will be taken from each patient. Data
      entry and analysis will be done with SPSS 23.
    

Intervention name(s): Dry Needling; Sham Dry Needing
Intervention type(s): Other; Other
Intervention description(s): abc; xyz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Patellofemoral Pain Syndrome; Dry Needling; Trigger Points
An Exploratory Investigation of a Novel Skincare Regimen
Condition: Wrinkle; Photoaging; Acne; Skin Inflammation
MeSH terms: Dermatitis; Inflammation
Study type: Interventional

Summary: 
      This trial will assess the effectiveness of the Aria Trio Complete Facial system in being
      able to reduce blemishes, lines, and wrinkles. This skincare system that has three different
      functions in association with three unique serums. It is hypothesized that this customized
      skincare system will improve skin quality, reduce wrinkles, and reduce other skin related
      issues.
    


Intervention name(s): Aria Trio complete Facial System
Intervention type(s): Other
Intervention description(s): Renew Serum, Brighten Serum, and Refine Serum.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: wrinkles; fine lines; photoaging; sun spots; acne; enlarged pores; skin health
Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy Subjects
Condition: Type-2 Diabetes; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the GLP-1 and non-GLP-1 effects of LAF237 on glucagon
      secretion, using treatment observations of the overall glycemic response.
    


Intervention name(s): Vildagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Hyperglycemia; Healthy; Vildagliptin; Adults
Comparison of Joint Mobility Levels and Performance in Young Male Basketball Players and Sedentary Peers
Condition: Hypermobility, Joint
MeSH terms: Joint Instability
Study type: Observational

Summary: 
      The aim of our study was to determine the joint mobility levels and its effects on
      performance in male basketball players and their sedentary peers aged 16-22 years.

      According to the studies on the effect of hypermobility on the performance; The young
      athletes who played tennis had lower equilibrium results than those without hypermobility.
      Although there is not any study that investigate its effects in basketball, there are studies
      for tennis and volleyball in literature.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The e-picos website was used to calculate the sample size. We used correlation coefficient
        (r = 0.505) from Acar et al's study in tennis players according to flamingo test results.
        When 90% power for each group is determined as α = 0.05, sample size is determined as 37.
        Considering the possibility of drop out by 10 percent, the sample size was determined as
        41. 41 basketball players and 41 sedentary peers were included in the study.
      
Keywords: Basketball; Sedentary; Joint Mobility; Performance
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on
      the long-term safety in patients with asthma, who completed the 24-week evaluation of study
      APTA-2217-05. Roflumilast will be administered orally once daily. The present study consists
      of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05
      (registered study). The study will provide further long-term safety and efficacy data of
      roflumilast.
    


Intervention name(s): Roflumilast
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Roflumilast; phosphodiesterase 4 inhibitor
Use of Blood Biomarkers and Biomarker Index to Aid in the Diagnosis of Obstructive Sleep Apnea (OSA)
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      This multicenter prospective trial will evaluate the association between obstructive sleep
      apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled
      symptomatic patients with a clinical suspicion of OSA.
    


Intervention name(s): blood biomarker
Intervention type(s): Diagnostic Test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Symptomatic patients with a clinical suspicion of obstructive sleep apnea
      
Biospecimen description: 
      Whole blood and serum
AZD5069 Neutrophil Function Study
Condition: Chemokine Receptor 2 (CXCR2) Antagonist
Study type: Interventional
Phase: Phase 1

Summary: 
      Study in healthy volunteer to see effect of AZD5069 and placebo on neutrophil number and
      function (phagocytosis and oxidative burst) in the circulation, following a burst of
      strenuous exercise and following subcutaneous injection of granulocyte-colony stimulating
      factor (G-CSF)
    

Detailed description: 
      A Randomised, Double-blind, Placebo-Controlled, Two-way Cross-over, Single Centre Study in
      Healthy Subjects to Assess the Effect of Oral Dosing of AZD5069 on Neutrophil Number and
      Function in Peripheral Blood and the Ability to Recruit Neutrophils into the Circulation
      after Exercise and Subcutaneous
    

Intervention name(s): 100 mg (50 mg x 2) AZD5069; 100 mg Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily for 7 days; Twice daily for 7 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1, AZD5069, safety and tolerability, healthy volunteer,
A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients
Condition: Stable Atherothrombotic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS)
      may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent
      cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single
      ascending dose study in patients with stable atherothrombotic disease in whom the safety and
      pharmacokinetic profile of CSL112 will be assessed.
    


Intervention name(s): CSL112 (reconstituted high density lipoprotein); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single escalating intravenous doses of CSL112; Single intravenous doses of normal saline (0.9%)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Pulse Control Using USG and Manual Palpation Methods in Cardiopulmonary Resuscitation
Condition: Cardiopulmonary Resuscitation
Study type: Observational [Patient Registry]

Summary: 
      The final approach adopted in Advanced Cardiac Life Support (ACLS) guidelines as defined by
      the American Heart Association (AHA) and the European Resuscitation Council (ERC) is to
      minimize the time between chest compressions in cardiopulmonary resuscitation (CPR). Pulse
      and rhythm checks are recommended between chest compressions and it is stated that this
      period should not exceed 10 seconds.

      All guidelines also state that in cases of low cardiac output or low blood pressure, even if
      electrocardiographic (ECG) rhythms can be obtained, pulse checks may still fail and an
      arterial pulse may not be felt during chest compressions. This difficulty in sensing the
      arterial pulse causes delays in the decision of cardiac arrest in the patient. For this
      reason, there are cases of cardiac arrest in which the initiation of CPR is delayed or not
      started at all.

      The most common method for checking the pulse is manual palpation. However, since it is an
      operator-dependent method, it is affected by the experience of the healthcare personnel, the
      vital values of the patient, and anatomical differences. Therefore, more objective criteria
      are required to detect a pulse. A clinical study of the reliability of pulse checks showed
      that most healthcare professionals are unable to detect the presence or absence of a pulse.
      Another study showed that pulse alone is not sufficient to initiate CPR, and 50% of decisions
      to initiate CPR based on heart rate are incorrect. Therefore, more objective criteria have
      been sought to detect the presence of a pulse. For this purpose, evaluations were made
      regarding the presence of end-tidal carbon dioxide, cardiac echo, and organized rhythm.
    


Intervention name(s): cardiopulmonary resuscitation
Intervention type(s): Procedure
Intervention description(s): pulse checks during cardiopulmonary resuscitation
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients over 18 years old
      
Keywords: carotid artery; pulse check; Cardiopulmonary Arrest
A Study of ISIS 416858 Administered Subcutaneously to Participants With End-Stage Renal Disease (ESRD) on Hemodialysis
Condition: End-stage Renal Disease (ESRD)
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ISIS
      416858 for up to 204 participants with ESRD receiving chronic hemodialysis as assessed by FXI
      activity reduction.
    

Detailed description: 
      Evaluation of safety, PK, and PD of ISIS 416858 (Dose # 1, Dose #2 and Dose #3 once weekly)
      as compared to placebo as assessed by FXI activity reduction.
    

Intervention name(s): ISIS 416858; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection; Subcutaneous injection
Other intervention name(s): IONIS-FXIRx; 0.9% sterile saline; Riboflavin
Intervention MeSH terms: Riboflavin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Randomized Trial Comparing Misoprostol and Foley Bulb for Pregnancy Termination in the Second Trimester
Condition: Pregnancy Trimester, Second; Induced Abortion
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare two methods of pregnancy termination on the time to
      delivery in the second trimester.
    

Detailed description: 
      Medical termination in the second trimester is performed for many indications. Successful
      termination is dependant on ripening of the cervix prior to labor induction. Multiple methods
      of cervical ripening and labor induction have been used for pregnancy termination in the
      second trimester. These two methods have different mechanisms of action. This study seeks to
      evaluate the effectiveness of these two methods.
    

Intervention name(s): Foley bulb; misoprostol
Intervention type(s): Device; Drug
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: second trimester; pregnancy termination; misoprostol; foley bulb
Effects of Fasting and Hydro Colon Therapy Plus Probiotics on GI Microbiota in Intolerances and Irritable Bowel Syndrome
Condition: Irritable Bowel Disease
MeSH terms: Intestinal Diseases; Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      Consequences of Colon Hydrotherapy plus probiotic intervention on composition of GI
      microbiota and well being are analysed in subjects claiming GI inconveniences due to
      Irritable Bowel Syndrome or food intolerances.
    

Detailed description: 
      Study objectives: Analysis of consequences of Hydro Colon Therapy plus probiotic intervention
      on GI microbiota and well being.

      Study group: 78 subjects, inclusion criteria: 20-50yrs; under consultation at doctors or
      nutritionists because of claimed food inconveniences or Irritable Bowel Syndrome. exclusion
      criteria: antibiotics treatment and specified complex diseases.

      Intervention: Hydro colon therapy 2- 5 washes within 3 weeks. probiotic intervention after
      end of Hydro colon therapy for 6 weeks ( DUOLAC® bacterial strains per capsule: Lactobacillus
      plantarum, Streptococcus thermophiles, Lactobacillus acidophilus, Lactobacillus rhamnosus,
      Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium breve,
      fructooligosaccharides, 200 µg folic acid, 2.50 µg vitamin B12 and 55 µg selenium (all
      amounts corresponding to 100% of daily requirement). Control group: Vitamin B complex: 10µg
      cobalamin, 450µg folic acid, and 55 µg selenium.

      Sample collection: standardized Feces collection, T1, before colon hydrotherapy, T2,
      immediately after colon hydrotherapy 2-5 washes of fasting ; T3, after six weeks of probiotic
      or Control intervention Analysis: standardizes food frequency questionnaire before and after
      intervention.

      Feces analysis based on 16 S ribosomal DNA (rDNA) PCR DGGE and quantitative PCR (qPCR) and
      bioinformatic analysis.
    

Intervention name(s): Hydro Colon Therapy plus probiotic
Intervention type(s): Other
Intervention description(s): Probiotic intervention was done after 2-5 cycles of hydro colon therapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: irritable bowel disease; microbiota; hydro colon therapy; food intolerance
Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia
Condition: Pain, Postoperative; Surgery, Thoracic
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study was to analyze a relationship between information support provided by
      an interdisciplinary team and the levels of anxiety, pain and satisfaction with postoperative
      analgesia in children and adolescents subjected to thoracic surgeries.
    

Detailed description: 
      The study included 112 consecutive pediatric patients qualified for lateral thoracotomy or
      Ravitch procedure. The subjects were randomized to the control group (n=56) provided with a
      routine preoperative information from a nurse, and the experimental group (n=56) offered
      additional psychological consultation.
    

Intervention name(s): Routine preoperative information from a nurse; Additional information support from a psychologist
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Routine preoperative information from a nurse.; Routine preoperative information from a nurse + additional information support from a psychologist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: anxiety; preoperative education; psychologist; thoracotomy; Ravitch procedure; postoperative pain
Defibrotide Therapy for SARS-CoV2 (COVID-19) Acute Respiratory Distress Syndrome (ARDS)
Condition: COVID; Sars-CoV2; COVID-19; Acute Respiratory Distress Syndrome
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial will enroll participants that have pneumonia caused by the COVID-19
      virus. During the study patients will receive 7 to up to 14 days of defibrotide. After
      completing the treatment, participants will have 30 day follow-up check-up to assess for
      adverse events and clinical status. This final assessment can be done virtually, by telephone
      or electronically (email) if the patient cannot be contacted by phone. No in-person visit is
      required.

      The hypothesis of this trial is that defibrotide therapy given to patients with severe
      SARS-CoV2 ARDS will be safe and associated with improved overall survival, within 28 days of
      therapy initiation.
    


Intervention name(s): Defibrotide
Intervention type(s): Drug
Intervention description(s): All patients will receive 25 milligram/kilogram/day (mg/kg/day) of defibrotide, given in 4 divided doses (approximately every 6 hours), each dose infused over 2-hours intravenously (IV).
The planned duration of study therapy is 7 days (while in the hospital), with the following qualifications:
Patients who respond to study therapy prior to day 7 (able to discontinue oxygen) will discontinue study therapy at that earlier time point.
Patients who have not responded to study therapy by day 7 of therapy, evidenced by <20% reduction (or a worsening) of the amount of supplemental oxygen they are receiving, will discontinue study therapy at day 7.
Patients who have evidence of a partial pulmonary response by day 7 (>20% reduction in supplemental oxygen requirement, but still require supplemental oxygen) may elect to continue to receive study drug through an additional 7 days of study (total 14-day therapy course).
Other intervention name(s): defitelio
Intervention MeSH terms: Defibrotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment