bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1 AVB-S6-500 Safety and Tolerability Study
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized single-blind, placebo-controlled, Phase 1, single ascending dose (SAD)
      and repeat dose (RD), safety and tolerability study of AVB-S6-500 in healthy subjects. A SAD
      portion of the study consists of 4 sequential dose escalation cohorts, whereas RD portion of
      the study consists of a single cohort receiving 4 weekly doses of AVB-S6-500. In both SAD and
      RD study arms, subjects are randomized to receive either a study intervention (AVB-S6-500) or
      matching placebo.
    


Intervention name(s): AVB-S6-500; Placebo
Intervention type(s): Drug; Other
Intervention description(s): AVB-S6-500 is an investigational drug.; Matching placebo
Other intervention name(s): AVB500
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study has two portions: a single ascending dose (SAD) portion consisting of 4 sequential dose escalation cohorts, and a repeat dose (RD) portion. In both study portions, subjects are randomized to receive either a study intervention (AVB-S6-500) or a placebo.
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Assess Wound Healing Efficacies of Different Clean, Treat, and Protect Wound Care Regimens Compared to Standard of Care and Untreated
Condition: Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the healing rates of wounds treated with various
      wound care regimens including antiseptic wound wash, topical antibiotic treatment, adhesive
      bandages, and/or hydrocolloid bandages.
    


Intervention name(s): SoC Adhesive Bandage; Antibiotic Ointment; Antiseptic Wash; Hydrocolloid Pad
Intervention type(s): Device; Drug; Drug; Device
Intervention description(s): On the randomized wound site, a SoC adhesive bandage will be applied.; On the randomized wound site, a antibiotic ointment will be applied.; On the randomized wound site, a antiseptic wash will be applied.; On the randomized wound site, hydrocolloid pad will be applied.
Intervention MeSH terms: Anti-Bacterial Agents; Anti-Infective Agents, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to
      evaluate the efficacy and safety of rituximab compared with placebo when combined with a
      single stable background immunosuppressive medication in subjects with moderate to severe
      systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be
      evaluated at 52 weeks.
    


Intervention name(s): Rituximab; Placebo; Prednisone; Acetaminophen; Diphenhydramine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Rituximab will be supplied as a sterile liquid for IV administration.; Placebo will be supplied as a sterile liquid for IV administration.
Other intervention name(s): Rituxan; MabThera; Zytux
Intervention MeSH terms: Acetaminophen; Diphenhydramine; Promethazine; Prednisone; Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rituxan; SLE; Lupus
Evaluation of the Integrated Radio Frequency Denervation System for the Treatment of Hypertension
Condition: Hypertension; Metabolic Syndrome
MeSH terms: Hypertension; Metabolic Syndrome
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the safety of renal denervation using the iRF
      System and to understand any potential improvement in hypertension.
    

Detailed description: 
      This study is a prospective, single-arm, multi-center, non-randomized trial to evaluate the
      initial safety and performance of renal denervation with the iRF system for the treatment of
      hypertension.
    

Intervention name(s): iRF System Renal Denervation
Intervention type(s): Device
Intervention description(s): The iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the artery
Intervention model: Single Group Assignment
Intervention model description: The study is a prospective, single-arm, multi-center, non-randomized feasibility trial
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Renal Denervation
Effect of Probiotic Lozenge on Gingivitis and Periodontitis
Condition: Mild and Moderate Chronic Periodontitis
MeSH terms: Gingivitis; Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The oral cavity is mostly influenced by general health. The oral microbiota which is as
      complex as the gastro-intestinal or vaginal microbiota are considered to be difficult
      therapeutic targets. The effects of probiotics in different fields of health care have
      resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been
      clinically proved effective in different fields of oral healthcare such as halitosis, oral
      candidiasis and tooth decay. They have also been inducted in the field of periodontal
      healthcare because of the current views on the etiology of plaque- related periodontal
      inflammation.
    


Intervention name(s): Probiotic Arm; Placebo Arm
Intervention type(s): Drug; Drug
Intervention description(s): Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2; Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RDX5791 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the
      safety, tolerability, pharmacokinetics, and pharmacodynamics of single-and multiple-ascending
      doses of RDX5791 in healthy male and female subjects.
    

Detailed description: 
      In the single-ascending dose (SAD), 5 separate cohorts received RDX5791 at various doses once
      po fasting. Each cohort of 8 subjects (6 RDX5791, 2 placebo) received a diet standardized fro
      Na+ content wile in the clinical pharmacology unit (CPU).

      The PK data from the 50-mg dose and the safety data from the 150-mg dose of the SAD study
      were evaluated prior to proceeding with the multiple-ascending dose (MAD) phase. Doses of
      RDX5791 are 3, 10, 30, and 100 mg administered once daily po fasting. Four cohorts of 10
      subjects each (8 RDX5791, 2 placebo) received a diet standardized for Na+ content while in
      the CPU.

      Safety assessments including clinical assessment and vital signs, clinical laboratory
      evaluations, ECGs, and AE monitoring were performed at regular intervals. Plasma was
      collected at regular intervals for PK analysis. The PD assessment included stool frequency
      and consistency, as well as changes in urinary Na+ excretion. All bowel movements were
      collected and analyzed for Na+ content outside this study protocol.
    

Intervention name(s): RDX5791; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Tenapanor; AZD1722
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Phase I; Healthy; Pharmacokinetics; Pharmacodynamics
Comparing Press and Filiform Needle Acupuncture Effectiveness for Improving Insomnia in COVID-19 Healthcare Workers
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of manual acupuncture between 2
      types of needles in subsiding insomnia symptoms of healthcare workers who were responsible
      for treating COVID-19 Patients in Cipto Mangunkusumo hospital.
    

Detailed description: 
      The purpose of this study is to compare the effectiveness of manual acupuncture between press
      needles and filiform needles for subsiding insomnia symptoms based on changes in the
      Pittsburgh Sleep Quality Index (PSQI) questionnaire score and examination of Melatonin in
      blood. If the press needles proven to be superior, this method would also be more beneficial
      during this pandemic as this can shorten the time and/or frequency of the therapy sessions,
      hence reducing interaction and risk of COVID-19 transmission.
    

Intervention name(s): Press needles; Filiform Needles
Intervention type(s): Procedure; Procedure
Intervention description(s): Manual acupuncture using press needles; Manual acupuncture using filiform needles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Press Needle; Insomnia; Healthcare worker
Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome
Condition: OHSS
MeSH terms: Ovarian Hyperstimulation Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to compare the efficacy of calcium gluconate infusion versus
      cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients
      pretreated with GnRH agonist long protocol who are at high risk for OHSS.
    

Detailed description: 
      Ovarian hyperstimulation syndrome (OHSS) is a serious complication of assisted reproduction.

      Previous studies revealed that calcium gluconate infusion reduced the risk of OHSS. Other
      studies revealed that cabergoline (potent dopamine receptor agonist on D2 receptors)was
      effective in preventing OHSS.

      The aim of this study is to compare the efficacy of calcium gluconate infusion versus
      cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in patients
      pretreated with GnRH agonist long protocol who are at high risk for OHSS.
    

Intervention name(s): Cabergoline; Calcium gluconate
Intervention type(s): Drug; Drug
Intervention description(s): Cabergoline (Dostinex; Pfizer, Italy) at a daily dose of 0.5 mg is administered orally at bed time for 8 days starting on the day of HCG administration; Intravenous 10% calcium gluconate, 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1, day 2, and day 3 after ovum pickup. Intravenous infusion will be performed within 30 minutes.
Intervention MeSH terms: Cabergoline; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: OHSS; Infertility; Cabergoline; Calcium gluconate; IVF-ET
The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.
Condition: Unexplained Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Recent research has revealed that subtle abnormalities can be found in sperm samples that
      seem to be normal with conventional analysis techniques. The DNA in the sperm heads is
      sometimes fragmented and this may be the reason why couples with a diagnosis of unexplained
      infertility do not achieve pregnancy.

      We are planning a study to examine the incidence of DNA fragmentation in the sperm of couples
      with previously unexplained infertility. In a first treatment cycle with intra-uterine
      insemination the percentage of DNA fragmentation in sperm will be measured. Afterwards the
      results of the patients who are pregnant will be compared with those of the not pregnant
      ones. We expect to find differences between both groups.

      100 patients will be included in the study.
    


Intervention name(s): Sperm Chromatin Dispersion Test
Intervention type(s): Other
Other intervention name(s): Halosperm®
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with unexplained fertility treated with intra-uterine insemination (first cycle)
        and ovulation induction with clomiphene citrate.
      
Biospecimen description: 
      Sperm samples
Comparison of the Effectiveness of the Outpatient Classical Ketogenic Diet and Modified Atkins Diet on Seizures Frequency, Nutritional Status and Some Biochemical Factors in Children and Adolescents With Intractable Epilepsy
Condition: Epilepsy Intractable
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Epilepsy is one of a common neurological disorder. Antiepileptic drugs (AEDs) are usually the
      primary treatment of epilepsy. However, almost 30% of patients do not respond to AEDs and
      other treatments including ketogenic diet (KD) are used. The Ketogenic Diet (KD) is a
      low-carbohydrate, high fat, adequate-protein diet. In this study, investigators are going to
      compare two kinds of the ketogenic diet namely classical ketogenic diet and modified Atkins
      diet. Fifty children and adolescents with intractable epilepsy will be included, 25 patients
      in each group, and will receive the diet for three months on non-randomised basis. In the
      classical ketogenic diet, the diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each
      gram of carbohydrate plus protein, will be introduced. Classical ketogenic diet will be
      established on outpatient setting, without fasting and gradually. The modified Atkins diet
      will be applied by the ratio of 1:1 or 2:1, each 1 or 2 grams of fat to each gram of
      carbohydrate plus protein.
    


Intervention name(s): Classical ketogenic diet; Modified Atkins diet
Intervention type(s): Other; Other
Intervention description(s): The classical ketogenic diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually.; The modified Atkins diet with a ratio of 1 or 2 to 1 (1:1, 2:1), each 1 or 2 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually.
Other intervention name(s): MAD
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine
Condition: Tularemia
MeSH terms: Tularemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine the safety and immunogenicity of a Live Francisella
      tularensis Vaccine
    

Detailed description: 
      Study was designed as a continuation of previously published research and targets subjects
      who were at risk of occupational exposure to F tularensis virus. Based on screening
      examinations; if a subject had a positive baseline titer (<1:20) and gave no history of
      significant exposure to F tularensis or history of tularemia disease, had never received
      tularemia vaccination, and was at risk of exposure to F tularensis they could be enrolled in
      this protocol to receive vaccination. Subjects returned for follow-up exams on Days 1, 2, and
      7; once between Days 12 and 16; and once between Days 28 and 35 post-vaccination. If titers;
      after blood samples on Days 28, 35 and 12 months showed <1:20 the vaccination could be
      repeated at Days 56-84. If the repeat titer remained <1:20, a booster vaccination could be
      administered. Subjects could be boosted 2 times with 1 year. If the titer measured 12 months
      after vaccination (+30 days) was >1:20 and the subject had no lingering AEs, the subjects
      participation was considered complete.
    

Intervention name(s): Live F tularensis Vaccine
Intervention type(s): Biological
Intervention description(s): Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Live Vaccine Strain (LVS), Bacterial Infections, Ulceroglandular, Oculoglandular
Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
Condition: Breast Cancer; Obesity; Overweight
MeSH terms: Breast Neoplasms; Overweight; Weight Loss
Study type: Interventional

Summary: 
      The primary objective of this pilot study is to determine the effect of weight loss on a wide
      range of biomarkers associated with risk of breast cancer recurrence in overweight and obese
      breast cancer survivors. We hypothesized that weight loss would result in a statistically
      significant improvement in biomarkers associated with risk of breast cancer recurrence.
    

Detailed description: 
      Women who are overweight, obese or gain weight after a breast cancer diagnosis are at greater
      risk for recurrence and death compared with lighter women. There have been a few studies
      examining the effects of different interventions on weight loss in breast cancer survivors
      but very few have examined the effect of weight loss interventions on circulating levels of
      markers associated with cancer risk. The overall objective of this proposal is to determine
      how weight loss affects circulating levels of biomarkers associated with breast cancer risk
      and recurrence, and quality of life of overweight and obese breast cancer survivors. The
      central hypothesis is that weight loss will decrease the levels of markers adversely
      associated with breast cancer and increase quality of life in these women. To test the
      central hypothesis the following specific aims will be pursued:

        -  To assess the effects of two different weight loss interventions on biomarkers
           associated with breast cancer risk and recurrence

        -  To assess the impact of the weight loss interventions on quality of life and sleep

        -  To assess the impact of weight loss on measures of bone health
    

Intervention name(s): Calorie restricted diet plus exercise; Weight management classes
Intervention type(s): Other; Other
Intervention description(s): Daily meals plus exercise providing 1000 kcal restriction per day for 12 weeks.; Weekly 1-hour weight management classes for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Ultrasonography of the Neck: The Influence of Airway Devices on Vascular Topography in Pediatric Patients
Condition: Ultrasonography, Pediatrics, Overlap, Vascular Structures
Study type: Observational

Summary: 
      Internal jugular venous catheterization is a challenging procedure in pediatric patients due
      to small size. Overlapping of the internal jugular vein (IJV) and common carotid artery (CCA)
      may jeopardize the success and increase the complication rate.However, the use of ultrasound
      as an assistance tool might be helpful to identify the relationship between the IJV and the
      CCA. Endotracheal intubation and insertion of laryngeal mask are the common options for the
      airway management during general anesthesia for central venous catheterization. In this
      observational study, the investigators aimed to investigate the impact of the laryngeal mask
      insertion or endotracheal intubation and the role of head rotation on the overlap of the IJV
      and CCA evaluated with ultrasound in pediatric patients undergoing any kind of surgical
      procedure.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The pediatric population who were undergone any type of surgery under general anesthesia
Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts
Condition: Asthma; House Dust Mite Allergy
MeSH terms: Asthma; Dust Mite Allergy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety of different doses of sublingual
      tablets of house dust mite allergen extracts in adults with house dust mite-associated
      allergic asthma.
    


Intervention name(s): SLIT tablets of house dust mite allergen extracts; Matching placebo
Intervention type(s): Biological; Biological
Intervention description(s): 10 dosing days; 10 dosing days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ramped and Sniffing Position for Cesarean Section Intubation.
Condition: Intubation; Difficult or Failed
Study type: Interventional

Summary: 
      This study will include pregnants who preferred to undergo general anesthesia for elective
      cesarean section. Ramped and sniffing positions of pregnant women during ventilation and
      intubation will be compared. The aim of this study is to investigate which position provides
      easier and faster intubation in pregnant women for cesarean section.
    

Detailed description: 
      Estimates of the frequency of difficult and failed intubation in the obstetric population
      vary within a wide range of percentiles. Several times higher than those reported for the
      general surgery population. Functional Residual Capacity decreases by 10% - 25% in Pregnant
      women. Pregnant women are more susceptible to hypoxia as a result of this decline, which also
      encourages intubation to occur more rapidly. Intubation success and shortening of intubation
      time have improved positively with videolaryngoscopes. On the other hand, the position of the
      patient during intubation contributes to the speed and success of intubation. It has been
      shown that intubation is faster and first-pass success is higher in the ramped position in
      morbidly obese patients.This study will compare the effectiveness of ramp and sniffing
      positions on intubation time and success in obese patients and pregnant women with similar
      physical changes.
    

Intervention name(s): Ramped position group; Sniffing position group
Intervention type(s): Other; Other
Intervention description(s): This position will be achieved by elevation of the shoulders and the head elevation till achieving alignment of sternal notch and external auditory meatus; This position will be achieved by placing a 7 cm pillow under the occiput.
Other intervention name(s): Ramped position; Sniffing group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two group;
Experimental Group: Group R; Ramped Group; Pillows will be placed under the patient's upper body and head, with the external auditory canal and sternal notch horizontal.
Sham Comparator: Group S; Sniffing Group; A 7 cm high pillow will be placed under the occiput while the patient is in the supine position.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Cesarean section; Intubation; Videolaryngoscopy