bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers
Condition: Overweight and Obese Volunteers.
MeSH terms: Obesity; Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The prevalence of overweight and obesity is getting more and more important in developed as
      well as in emerging countries. It can be defined according to the degree of fat storage by
      measurement of fat mass.

      No clinical studies have been conducted so far for that intended use on KiOnutrime®-Cs, a
      fungal chitosan from the mycelium of non-genetically modified Aspergillus niger.
      KiOnutrime®-Cs has been recognized as substantially equivalent to animal chitosan.

      The purpose of this clinical trial is to determine if KiOnutrime®-Cs-containing medical
      device, which is a CE-marked medical device manufactured by KitoZyme, has an effect on body
      weight reduction after 3 months of intake in overweight and obese men and women. Furthermore,
      effects on anthropometric measurements, body fat mass percentage, serum lipids and safety
      parameters will be investigated.
    

Detailed description: 
      The study duration per subject will be 3 months and 1 week maximum. Subjects will be screened
      at visit V1 and will start a 1-week run-in period, during which subjects will ingest 2
      capsules of placebo 3 times a day.

      The subjects will then be randomized to receive the investigational medical device or placebo
      (1:1) for a 3 months product intake period.
    

Intervention name(s): KiOnutrime®-Cs; Placebo
Intervention type(s): Device; Other
Intervention description(s): The product will be taken orally within 15 minutes before main meals (breakfast, lunch and dinner) with a large glass of water. Subjects will have to take 2 capsules of 500mg, 3 times per day.; The product will be taken orally within 15 minutes before main meals (breakfast, lunch and dinner) with a large glass of water. Subjects will have to take 2 capsules, 3 times per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; overweight; chitosan; fungal chitosan; weight management
One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study
Condition: Osteoporosis; Humoral Hypercalcemia of Malignancy; Hyperparathyroidism
MeSH terms: Neoplasms; Osteoporosis; Hypercalcemia; Hyperparathyroidism
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a dose escalation study to determine the maximum tolerable dose of Parathyroid
      Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators
      plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and
      progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy
      (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally,
      the investigators will assess the direct influence of PTHrp on markers of bone turnover, and
      plasma 1,25 (OH)2 vitamin D regulation in healthy human volunteers.
    

Detailed description: 
      During this research the investigators administer PTHrP to healthy young volunteers in a
      controlled, continuous intravenous manner. As research subjects complete the week-long study
      without adverse effects, the dose of PThrP will be increased in later subjects. In the event
      of a significant adverse effect, immediate action will be taken to reverse it. The
      investigators want to estimate the effect of a sustainable level of mild hypercalcemia
      achieved by a week-long intravenous infusion of PTHrP has on vitamin D metabolism, markers of
      bone turnover and fractional excretion of calcium.
    

Intervention name(s): PTHrP (1-36)
Intervention type(s): Drug
Intervention description(s): IND # 49,175
Other intervention name(s): Parathyroid Hormone-related Protein (1-36)
Intervention MeSH terms: Parathyroid Hormone; Parathyroid Hormone-Related Protein
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Endocrine System Diseases; MusculoSkeletal System Diseases; Hormones; Malignancy; Postmenopausal Women; Bone metabolism
The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this investigation is to evaluate whether exenatide, a type 2 diabetes
      medication, will improve the function of the innermost part of the arterial wall called the
      endothelium after a fat-enriched meal and to determine how this occurs. The results of this
      study will help to determine and understand a novel action of this group of diabetes
      medications based on the action of naturally occuring gut substances called incretins. This
      may have a significant impact on cardiovascular health in patients with early and
      longstanding diabetes.
    

Detailed description: 
      Two independent, double-blinded, crossover substudies will be conducted to test the effect of
      exenatide on daylong post-meal and fasting endothelial function. We will measure endothelial
      function measured by peripheral arterial tonometry (EndoPAT2000, Itamar Inc.). Patients with
      recent onset (<3 years) or established (>5 years, Substudy 1 only) diabetes and impaired
      sugar tolerance (Substudy 2 only) will be studied. The plan is to complete studies in 75
      patients (40 in Substudy 1 and 35 in Substudy 2).

      In Substudy 1 patients will get twice a day a skin injection of exenatide (Byetta) or
      identically looking placebo for 10 days, separated by 14-day period. On the next day after
      each treatemnt period (day 11), they get just one injection and eat a fat-enriched breakfast.
      A fatty lunch of similar caloric content will be given 4 hours following the breakfast.
      Endothelial function will be measured just prior to the injection and every 2 hours for total
      8 hours.

      In Substudy 2, patients on 3 different days will get infusion of exenatide withg or without a
      blocking drug exendin-9, and a control test with placebo without exendin-9. Endothelial
      function will be measured before the infusion and 2 hours later during the final 15 minutes
      of the infusion cocktails. Patients will not eat any meal during the test visits.
    

Intervention name(s): Exenatide SC; Exenatide IV; Placebo SC; Exendin-9; Placebo IV
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Exenatide 5-10 ug sc BID/10 days; 50 ng/min intravenously for 45 minutes on 2 out of 3 study visits separated by 5-10 days; Placebo sc BID/10days; Primed (6,000 pM/kg), continuous (600 pM/kg) intravenous infusion for 75 minutes on 1 out of 3 study visits.; Intravenous infusion for 45 minutes on 1 out of 3 visits
Other intervention name(s): Byetta, exendin-4; exendin-4, Byetta; placebo; exendin-(9-39); placebo
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Type 2 diabetes mellitus, Impaired glucose tolerance
Flare Type Self-expandable Metal Stent for Malignant Colorectal Obstruction
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This study compares flare type self-expandable metal stent with conventional D-type
      self-expandable metal stent for malignant colorectal obstruction.
    


Intervention name(s): Flare type stent; Conventional D-type stent
Intervention type(s): Device; Device
Intervention description(s): Flare type has a wide diameter at proximal portion to prevent stent migration.; This stent is an original full covered stent to treat malignant colorectal obstruction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal cancer; stent
Efficacy and Safety of XP12B in Women With Menorrhagia
Condition: Menorrhagia; Heavy Menstrual Bleeding
MeSH terms: Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether XP12B is effective and safe in the
      treatment of women with heavy menstrual bleeding associated with menorrhagia.
    


Intervention name(s): Tranexamic acid tablets; Tranexamic acid tablets; Placebo tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3900 mg/Day; 1950 mg/Day
Other intervention name(s): Lysteda; XP12B; Lysteda; XP12B
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menorrhagia; Heavy Menstrual Bleeding
PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of peginterferon alfa-2a
      (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic
      hepatitis C virus (CHC) infection in children.

      The purpose of this study is also to determine whether PEG-2a in combination with RV or
      PEG-2a alone will result in a longer response rate in children with CHC.
    


Intervention name(s): Pegylated Interferon/ribavirin
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric; hepatitis; children; HCV; PEG; PEG-2a; peginterferon alfa-2a; Pegylated Interferon; RV; ribavirin; Pegasys; CHC; chronic hepatitis C; chronic hepatitis C virus; hepatitis c; pediatric hepatitis; pediatric HCV
The OHSU Pregnancy Exercise & Nutrition (PEN) Program
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational
Study type: Interventional

Summary: 
      Personal behaviors can influence development of Gestational Diabetes Mellitus (GDM), a
      condition that can adversely affect the pregnant woman, her developing fetus and future
      events for both. To reduce GDM risk, we will develop and implement an in-person team and
      web-based nutrition and exercise program for women, beginning in their first trimester. A
      scripted, peer-led, 20-week educational program, tailored for pregnant women working in teams
      (5 women/team), will be developed and implemented among pregnant employees and/or their
      spouses. Each weekly thirty minute session will focus on achieving 30-minutes of moderate
      daily physical activity with nutrition targets of five servings of fruits and vegetables, 3
      servings of whole grains and lower fat food choices. Diet, exercise and lab assessments will
      occur before enrollment during the first trimester, each subsequent trimester and 12 weeks
      after delivery. In addition to exercise and diet survey results, we will assess fasting
      glucose, insulin, hemoglobin A1C levels, pregnancy weight gain, blood pressure, lipid and
      lipoprotein levels, pedometer records, weekly accelerometer data, each trimester and at 12
      weeks post delivery, as well as gestational birth age, Apgar score, delivery mode and infant
      birth weight, and weekly health thermometer self-ratings during the assessment period.
    


Intervention name(s): Intervention, behavioral lifestyle education
Intervention type(s): Behavioral
Intervention description(s): Twenty interactive weekly sessions that are scripted curriculum and peer led.
Other intervention name(s): Lifestyle; Nutrition; Exercise; Stress management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gestational diabetes; Exercise; Diet; Fruits; Vegetables; Whole grains; pregnancy weight
Impact of Postoperative Telemedicine Visit vs In-person Visit on Patient Satisfaction During the COVID-19 Pandemic
Condition: Covid19; Satisfaction, Patient; Telemedicine
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The purpose of this clinical study is to evaluate whether remote video/audio postoperative
      visits (telemedicine visits) affects patient satisfaction compared to in-person visits during
      the COVID-19 pandemic. If the primary objective of the study is achieved, it would allow
      better understanding of how telemedicine can be integrated into modern surgical practice to
      take care of postoperative patients.
    


Intervention name(s): Telemedicine visit; In-person postoperative visit
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A postoperative visit with the patient's surgeon conducted remotely via audio/video smartphone app; A standard-of-care in-person postoperatively visit with the patient's surgeon
Other intervention name(s): Remote audio/video visit, telehealth visit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Covid19; Patient satisfaction; Telemedicine
Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy
Condition: Sleep Apnea, Obstructive; Pre-Eclampsia; Hypertension, Pregnancy-Induced
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced
Study type: Interventional

Summary: 
      This is an open-label multicenter randomized-controlled trial in 3 tertiary care hospitals
      including Ramathibodi Hospital, Phramongkutklao Hospital and Rajavithi Hospital. The study
      involved screening of obstructive sleep apnea in high risk pregnancy during 1st and 2nd
      trimesters. Randomization to either continuous positive airway pressure (CPAP) or usual
      antenatal care (ANC) until delivery will be done. Efficacy of CPAP on pregnancy outcome will
      be analysed.
    

Detailed description: 
      Screening for sleep disordered breathing (Respiratory disturbance index, RDI ≥ 5 events/hour)
      with type 2 sleep test will be performed in eligible subjects during early1st trimester (<16
      weeks). Repeat sleep study will be done if the RDI in 1st trimester is less than 5. If the
      subjects meet the inclusion criteria without any of the exclusion criteria, randomization
      into either receiving CPAP treatment or usual ANC will be done. The pressure of CPAP machine
      is determined using autoCPAP machine algorithm at 90 percentile. Adjustment of CPAP machine
      is repeated at 24-28 week gestations. Subjects in both groups received standard usual care
      during ANC and outcomes were measured with similar case record forms.
    

Intervention name(s): Continuous positive airway pressure (CPAP)
Intervention type(s): Device
Intervention description(s): A non-invasive positive pressure device that is used for the treatment of obstructive sleep apnea by splinting the collapsed upper airway during sleep
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; Pre-Eclampsia
An Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacodynamic effects, pharmacokinetics, and
      safety of two oral formulations (tablet and capsule) of LX1033 in normal healthy volunteers.
    


Intervention name(s): 250 mg capsule; 250 mg tablets
Intervention type(s): Drug; Drug
Intervention description(s): Two 250 mg capsules will be administered for 500 mg dose; Two 250 mg tablets will be administered for a 500 mg dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy of Acupressure on Sleep Quality in Menopausal Women
Condition: Poor Quality Sleep
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Sleep disorder is a common problem in menopausal women and the decrease in the sleep leads to
      poor daily activity. Traditional Chinese acupressure is a noninvasive, effective and safe
      technique that can be easily taught to menopausal women so that they apply it as a self-care
      method and a manager of sleep disruption. The purpose of the present study was to evaluate
      the effectiveness of acupressure on sleep quality of postmenopausal women.This double blind
      randomized clinical trial was performed on 120 qualified menopausal women at the age of 41-65
      years; and sleep quality was measured with Pittsburgh Sleep Quality Index (PSQI
      ).Participants were randomly assigned to an acupressure group, a sham acupressure group and a
      control group by two time randomized method (systematic and simple randomized). These
      interventions were carried out for 4 consecutive weeks. Participants in acupressure group and
      sham acupressure group learned to carry out acupressure technique as a self care at home with
      the simultaneous massage techniques that were to be performed 2 hours before sleep, whereas
      only conversation was used in the control group. The statistical software package for social
      science (SPSS) Version 17 was used for data analysis.
    


Intervention name(s): true accupressure; sham acupressure
Intervention type(s): Other; Other
Intervention description(s): Four acupoints were chosen for subjects in the acupressure group. They were Shenmen on the wrist crease, Sanyinjiao point (SP6) on both feet, Fengchi on the hairline of the back neck (occipital area)and Yintang, at the top of the nose on the center line between the ends of the eyebrows.; Non-acupoints, which were 1 to 3 traditional Chinese unit of length (CUN) away from true acupoints, were used in sham acupressure group.These points were out of the route of energy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Menopause; Sleep quality; Acupressure
Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03829)(COMPLETED)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was conducted to compare the taste acceptability of Zyrtec syrup with
      desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each
      syrup, separated by 15 to 20 minutes on a single day.
    

Detailed description: 
      This study is a cross-over study design.
    

Intervention name(s): Desloratadine (Clarinex); Cetirizine (Zyrtec)
Intervention type(s): Drug; Drug
Intervention description(s): Each subject received 5 mL of desloratadine syrup one time; Each subject received 5 mL of cetirizine syrup
Other intervention name(s): SCH 034117, Clarinex; Zyrtec
Intervention MeSH terms: Cetirizine; Desloratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit?
Condition: Cervix Cancer; Endometrial Cancer; Ovarian Cancer; Breast Cancer
MeSH terms: Endometrial Neoplasms; Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      Opioid Free Anesthesia (OFA) is a multimodal anesthesia and emerging technique that spares
      the use of opioids and involve other adjuvant anesthetics, which have demonstrated in vitro
      influence on immunologic and inflammatory response, as well as in metastatic progression. For
      these reasons we believe that OFA may positively influence in oncologic patients
      postoperative recovery and in its disease progression.
    

Detailed description: 
      After Local Ethics Committee approval, consecutive consenting patients scheduled for major
      gynecologic oncologic surgery were included between February 2019 and January 2020 in this
      observational retrospective study. We Compared OFA to standard technique used in our
      institution and assessed its effect on Postoperative Systemic Inflammatory Response (SIRS),
      hospital stay, postoperative complications in the following 2 months, cancer progression and
      mortality 6 months and 12 months after surgery. OFA protocol consisted of a Total IntraVenous
      Anaesthesia of Propofol, a Dexmedetomidine infusion of 0,8-1,0 mcg/kg/h, together with
      0,2-0,3 mg/kg ketamine and lidocaine 1,5 mg/kg in the first hour of surgery. The standard
      anaesthetic protocol included opioids (Fentanyl 2mcg/kg at induction, and remifentanyl
      infusion 0,1-0,2 mcg/kg/min) and volatile agents (sevoflurane or desflurane). Patients in
      both groups received a regional block when possible, dexamethasone 8 mg at induction and
      paracetamol 1g plus dexketoprofen 50mg at the end of surgery. Continuous variables were
      compared using unpaired t-test (or Mann-Whitney U test) and categorical variables by
      Chi-square test. Statistical significance was set at p < 0.05
    

Intervention name(s): Opioid
Intervention type(s): Drug
Intervention description(s): Use of balanced anesthesia including opioids during anesthesia for gynecologic cancer surgery
Other intervention name(s): Opioid Free Anesthesia
Intervention MeSH terms: Analgesics, Opioid
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        132 women, aged 20-91 years old and ASA I-IV, who had Major Surgery for gynecologic cancers
        (cervix, endometrial, ovarian, vaginal, vulvar and breast cancer) under OFA and balanced
        anesthesia with opioids, both combined with regional anesthesia. They had surgery between
        February 2019 and February 2020 in Hospital La Paz de Madrid.
      
Keywords: Opioid; Opioid Free Anesthesia; SIRS (Systemic Inflammatory Response); Postoperative infection