bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of MultiStem® in Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplasia
Condition: Hematologic Malignancies
MeSH terms: Leukemia; Hematologic Neoplasms; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Preleukemia; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if MultiStem® can safely be given to patients with
      acute leukemia, chronic myeloid leukemia, or myelodysplasia after they have received
      hematopoietic stem cell transplantation.
    

Detailed description: 
      Graft-vs.-Host Disease (GVHD) is one of the major limitations of allogeneic hematopoietic
      stem cell transplants (HSCT). This complication is major cause of morbidity and mortality and
      is thought to be initiated by activation of donor T-cells through recognition of "foreign"
      cells resident in the transplant recipient. Acute GVHD is associated with damage to the
      liver, skin, gastrointestinal tract and mucosa. Moderate to severe GVHD Grades II-IV occurs
      in 30-50% of matched related HSCTs and 50-70% of unrelated donor recipients. Severe GHVD
      requires intense immunosuppression involving steroids and additional agents to get it under
      control, and patients may develop severe infections as a result of such immunosuppression. An
      agent or cell therapy that could reduce the incidence and/or severity of GVHD without
      increasing relapse or infectious risk in HSCT patients would provide substantial benefits.
    

Intervention name(s): MultiStem®; MultiStem®
Intervention type(s): Biological; Biological
Intervention description(s): Patients will receive a single IV infusion of MultiStem® 2 days after HSCT.; Patients will receive either 3 weekly IV infusions or 5 weekly infusions of MultiStem®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Leukemia; Graft vs. Host Disease; Hematopoietic Stem Cell Transplant; Bone Marrow Transplant; Myelodysplasia
Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The clinical trial studies patients with gingival recession defects (receding gums).

      The goal of the study is to test whether the additional use of enamel matrix derivatives
      (EMD), combined with the use of a coronally advance flap (CAF) and a CM (collagen matrix),
      shows a better outcome compared to a comparison group. The comparison group comprises
      patients receiving treatment with CAF and CM without the use of EMD.
    

Detailed description: 
      The study aims to evaluate the influence of the additional use of EMD in treatment of
      gingival recession defects using a coronally advance flap (CAF) and a CM (collagen matrix) by
      means of digital and clinical assessment methods. The reference group comprises patients
      receiving treatment with CAF and CM without the application of EMD.

      In this prospective, randomized, controlled study, recession height and area, width and
      thickness of keratinized gingiva, pocket probing depth, and the clinical attachment level
      were measured at baseline and followed-up for one year.

      15 patients with 24 gingival recession defects (Recession Type 1 after Cairo/Miller Class I
      or II) were recruited and were randomly assigned into the two treatment groups.
    

Intervention name(s): Use of coronally advanced flap (CAF) and collagen matrix (CM); Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: coronally advanced flap; collagen; enamel matrix protein; dental enamel protein; gingival recession; periodontal plastic surgery
Evaluating the Effectiveness of Colon Preparation for Endoscopy Using Specialized Clinical Nutrition
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is an open, prospective, comparative diagnostic studies aimed at improving the
      colonoscopy results, by optimizing the way of preparation for endoscopy
    

Detailed description: 
      Objective: to improve the quality of bowel preparation for endoscopy.

      Research objectives:

        1. Compare the three methods of colon preparation for endoscopy

        2. To develop a rational strategy of preparing patients for endoscopy on the basis of the
           data obtained.
    

Intervention name(s): Nutridrink 200 ml; Nutridrink compact protein
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Nutridrink 200 ml 6 bottles per day as a sole source of nutrition. On the day of the colonoscopy, as breakfast, allowed Nutridrink 1-2 bottles; 2 bottles per day. On the day of the colonoscopy, as breakfast, allowed Nutridrink compact protein 1-2 bottles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: colon preparation for endoscopy; enteral feeding; sip feeding; nutridrink; nutridrink compact protein
Relationship Between Endoplasmic Reticulum Stress and Pain in Patients With Endometriosis
Condition: Endometriosis; Endoplasmic Reticulum Stress; Endometriosis-related Pain
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The correlation between painful symptoms (dysmenorrhea, dysparonia, dysuria, chronic pelvic
      pain) symptoms and endoplasmic reticulum stress was investigated in 86 patients diagnosed
      with endometriosis. For this, xbp-1 (x box binding protein-1) level was measured in patients.
      XBP-1 is an endoplasmic reticulum stress indicator and is known to be involved in pain
      pathogenesis.
    

Detailed description: 
      Women between the ages of 18-50 who were diagnosed with endometriosis by surgery and
      ultrasound, without known rheumatological or metabolic diseases were included in the study.
      Most of the patients are composed of newly diagnosed patients.
    

Intervention name(s): xbp-1 - endometriosis patients group
Intervention type(s): Other
Intervention description(s): Patients diagnosed with endometriosis by surgery and ultrasound and whose xbp-1 level was examined
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women between the ages of 18-50 who were diagnosed with endometriosis by ultrasound or
        surgery and who did not have any rheumatological and metaboli disease were included in the
        study. women with drug use indicated in the last 3 months were excluded from the study.
A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
Condition: Migraine According to International Headache Society (IHS) Criteria (ICHD-II)
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is primarily designed to investigate whether treatment with vitamin D may influence
      migraine in a placebo-controlled, blinded study. The hypothesis is that vitamin D may serve
      as a prophylactic treatment of migraine. The hypothesis is tested by examining the changes in
      the pain and symptom patterns associated with migraine by treatment with Vitamin D, by means
      of quantitative sensory testing, diaries and blood samples for measurement of vitamin D.
      Other pain biomarkers are also measured to evaluate whether the levels of these biomarkers in
      the blood is changed by the treatment with vitamin D. The hypothesis here is that levels of
      those biomarkers will change following the treatment.
    


Intervention name(s): D3 Vitamin ®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vitamin D and placebo supplied as tablets in containers of 124. The containers must be kept in dry and not too hot environment.
All subjects randomized to vitamin D, will receive 100 micrograms of vitamin D3/day, equivalent to 4000 IU. Vitamin D is administered orally 1 time a day with breakfast.
Other intervention name(s): D3 Vitamin ®, supplied by D3 Pharmacy Ltd; Placebo tablets to match D3 Vitamin ®, produced by D3 Pharmacy Ltd
Intervention MeSH terms: Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Migraine; Vitamin D
Fascial Closure Techniques Post-Operative Pain Laparoscopy
Condition: Post-operative Pain; Fascial Closure
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study compares post-operative incisional pain on post-operative days 1 and 7 who will
      undergo gynecologic laparoscopic operations. Half of participants will undergo conventional
      fascial closure, while the other will undergo fascial closure by Berci Fascial Closure (Karl
      Storz, Belgium).
    

Detailed description: 
      Studies have demonstrated that laparoscopic surgery has numerous advantages over laparotomy.
      The patients who undergo laparoscopic surgery acquired fewer doses of analgesics than who
      undergo laparotomy. This point is also one of the advantages of the laparoscopic surgery. The
      fascia closure in fascial defects larger than 10 mm diameters in laparoscopic surgery is an
      important issue. Incisional hernias may occur after laparoscopic surgery. The surgeons prefer
      the techniques in fascial closure which is more safe and cause less pain. In current study,
      investigators aim to compare the post-operative incisional pain in two different techniques
      in gynecologic laparoscopic surgery; conventional versus by 'Berci Fascial Closure'.
    

Intervention name(s): Conventional technique; Berci technique
Intervention type(s): Procedure; Procedure
Intervention description(s): Conventional technique: In this group; S-retractors will be used to visualize the fascia and a single interrupted stitch will be placed using 0-vicryl suture.; Berci group: In this group; the fascial incision will be closed with the fascial closure device, (Berci Fascial Closure instrument) using 1 interrupted stitch with 0-vicryl suture.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: fascial closure device; laparoscopic surgery; postoperative pain
Fertility Awareness in University Students
Condition: Educational Video
Study type: Interventional

Summary: 
      Recent evidence showed that undergraduate students have inappropriate knowledge about
      reproductive health and infertility.

      The investigators' aim was to assess the effectiveness of a brief intervention (video) in
      increasing the knowledge regarding fertility issues, fertility risk factors and infertility
      definition.
    


Intervention name(s): Video
Intervention type(s): Other
Intervention description(s): Video-Audio Media
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: infertility; fertility awareness; health interventions; young adults
Pentax Videolaryngoscopy in Children
Condition: Intubation;Difficult
Study type: Observational

Summary: 
      Comparison of Intubation using Pentax (Pentas AWS, Pentax, Tokyo, Japan) and Macintoch in
      pediatric patients
    

Detailed description: 
      Pentax video laryngoscope (Pentas AWS, Pentax, Tokyo, Japan) is one of indirect optical
      laryngoscopes which is recently developed. Several studies have shown that the Pentax-AWS®
      provides full views of the glottis in the majority of patients. It makes successful tracheal
      intubation in patients after failed intubation using a Macintosh laryngoscope.

      In pediatric patients who is expected to be difficult to intubate, Pentax makes successful
      intubation.
    

Intervention name(s): Pentax
Intervention type(s): Device
Intervention description(s): Intubation using Pentax video laryngoscope in Pentax group
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients
Protein Supplementation in Infants With Brain Injury
Condition: Perinatal Stroke; Hypoxic-ischemic Encephalopathy; White Matter Injury
MeSH terms: Brain Injuries; Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Wounds and Injuries
Study type: Interventional

Summary: 
      To date, few studies have been done regarding nutrition supplementation in infants with brain
      injury. Therefore, the investigators are proposing to study the effects of protein
      supplementation in this group of babies. The investigators will recruit 24 infants with brain
      injury (evidence of hemorrhage, white matter injury, or gray matter injury) admitted to the
      Cincinnati Children's Hospital Neonatal Intensive Care Unit (NICU) into the study. Upon
      diagnosis, the investigators will obtain consent from the parents for participation in the
      study, then randomly assign the baby to one of two groups - an increased protein group and a
      control group. Both groups of infants will be monitored to ensure no adverse effects occur
      due to the supplementation.

      Protein supplementation will continue for the first 12 months of age. Growth parameters, such
      as weight, length, and head circumference, will be measured while the infant is the NICU.
      Head circumference will be measured in the investigators outpatient clinic at three, six, and
      12 months of age. At 18-22 months, the infants will be tested for neurodevelopmental outcomes
      using the Bayley Scales of Infant Development. The investigators hypothesize that infants who
      receive the additional protein will demonstrate increased head growth and improved
      neurodevelopmental outcomes.
    


Intervention name(s): Increased protein
Intervention type(s): Dietary Supplement
Other intervention name(s): Beneprotein or Complete Amino Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
COGNUTRIN in Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to examine the safety and influence of an intervention
      (COGNUTRIN) using nutritional supplements (n-3 fatty acids and blueberry anthocyanins) on
      cognitive performance in breast cancer survivors following chemotherapy. The investigators'
      goal is to treat or lessen the late effects of cancer treatment. The supplement to be used
      will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins
      from blueberries (BB) and (2) n-3 fatty acids - Lovaza.
    

Detailed description: 
      This pilot study will evaluate the feasibility of administration of the nutritional
      supplement and placebo in this patient population and performing cognitive function testing
      at baseline and post supplementation.

      This is a randomized, double-blind pilot study of COGNUTRIN vs. Placebo.

      Participants have an equal chance (like flipping a coin) of being in either of the study
      groups. Neither the participant nor the study doctor will be able to choose which study group
      the participant is in. Participants will not know and the study doctor will not know which
      study group the participants are in.
    

Intervention name(s): VitaBlue™; Placebo; Lovaza®
Intervention type(s): Drug; Other; Drug
Intervention description(s): Self administration of nutritional supplement COGNUTRIN for 3 months.
The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza.; Self administration of placebo for 3 months.
Investigators use a placebo to make sure that it really is the study medicine that is making a difference in the participant's condition. It does not have anything in it that would normally help or harm most people.; Self administration of nutritional supplement COGNUTRIN for 3 months.
The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza.
Other intervention name(s): blueberry (BB) Anthocyanins; omega-3-acid ethyl esters
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: polyphenolics; anthocyanins; n-3 fatty acids
Effect of Two Methods of Soft Tissue Augmentation for Socket Closure on Soft Tissue Landmarks and Ridge Dimensions
Condition: Recession, Gingival
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      To evaluate the effect of Connective Tissue Graft and Pediculated-Connective Tissue Graft for
      extraction socket closure on soft tissue landmarks and ridge dimensions.
    

Detailed description: 
      45 subjects were randomized into two groups Experimental: Main treatment group P-CTG group
      Active Comparator: Control group CTG group.
    

Intervention name(s): P-CTG; CTG
Intervention type(s): Procedure; Procedure
Intervention description(s): soft tissue closure of extraction sockets was done by pediculated connective tissue grafts (P-CTG); soft tissue closure of extraction sockets was done by connective tissue grafts (CTG)
Other intervention name(s): Experimental group; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Lanreotide as Treatment of Polycystic Livers
Condition: Polycystic Liver Disease; Hepatomegaly; Liver Diseases; Polycystic Kidney, Autosomal Dominant
MeSH terms: Liver Diseases; Hepatomegaly; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To assess the efficacy of lanreotide in controling total liver volume in patients with
      polycystic livers this study will be performed. A minimum of 38 patients will be recruited
      and randomized (1:1) to receive either verum or placebo. Lanreotide is already used in other
      disease states and found to be safe and non-toxic.
    


Intervention name(s): Placebo; Lanreotide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lanreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polycystic Liver Disease; Autosomal Dominant Polycystic Kidney Disease; Liver cyst; Lanreotide
Relationship Between LRG and Periodontal Disease
Condition: Periodontitis; Acute-Phase Response; Inflammation
MeSH terms: Periodontitis; Inflammation; Acute-Phase Reaction
Study type: Interventional

Summary: 
      This study aimed to investigate gingival crevicular fluid (GCF) and serum levels of LRG,
      interleukin (IL)-6 and tumor necrosis factor (TNF)-α in patients with periodontitis before
      and after non-surgical periodontal treatment.
    

Detailed description: 
      Twenty-five stage 3 periodontitis and twenty-five periodontally healthy individuals were
      enrolled in the study. Clinical periodontal measurements were recorded; periodontitis
      patients received non-surgical periodontal treatment, and GCF and serum samples were obtained
      at baseline and at 6 weeks after treatment. LRG, IL-6 and TNF-α were determined by ELISA.
    

Intervention name(s): Non-surgical periodontal treatment; Oral hygiene instructions
Intervention type(s): Other; Other
Intervention description(s): Scaling and root planing (SRP), in four clinical visits; Oral hygiene instructions includes brushing with the modified Bass technique, interdental cleaning with dental floss and interdental brushes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: periodontitis; gingival crevicular fluid; serum
Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery
Condition: Nausea; Vomiting; PONV
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The specific aim of this study is to determine the incidence of post-operative nausea and
      vomiting (PONV) in the pediatric population undergoing outpatient middle ear surgery.
    

Detailed description: 
      The specific aim of this study is to determine the incidence of post-operative nausea and
      vomiting (PONV) in the pediatric population undergoing outpatient middle ear surgery
      receiving our institution's standard dual prophylactic antiemetic therapy in combination with
      intraoperative acupuncture and postoperative acupressure compared to those receiving only the
      standard dual prophylactic antiemetic therapy.
    

Intervention name(s): Acupressure Band; Sham Band
Intervention type(s): Other; Other
Intervention description(s): These bands use pressure to stimulate the P6 acupuncture point.; These sham bands are used to make it seem like the band is using pressure to stimulate the P6 acupuncture point.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: acupuncture; acupressure
Apneic Oxygenation Via Nasal Cannulae Prevents Arterial Hypoxemia
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effectiveness of continuous oxygen provided by
      nasal prongs in preventing or delaying hypoxemia during the apneic period that occurs after
      induction of general anesthesia. This will be evaluated by measuring the arterial oxygen
      tension (PaO2).

      The study will also evaluate whether there is any difference in PaO2 when using nasal prongs
      with flow rates of 5 L/minute versus 10 L/minute of oxygen.
    

Detailed description: 
      Certain patient populations are at risk for rapid desaturation and the rapid development of
      hypoxemia (eg. morbidly obese and pregnant patients). Using pulse oximetry, it has already
      been shown that oxygen provided with a catheter inserted into the nasopharynx is effective in
      delaying the desaturation that occurs with apnea before the trachea is intubated. It has also
      been shown that apneic oxygenation with nasal prongs at 5 L/min during fibreoptic intubation
      can delay the onset of hypoxemia.

      The study will evaluate whether there is any significant difference in the PaO2 (arterial
      oxygen tension, as measured by an arterial blood gas) when nasal prongs are used to provide
      apneic oxygenation in paralyzed patients at flows of 5 L/min compared to 10 L/min.

      The study aims to demonstrate that apneic oxygenation using nasal prongs is effective in
      preventing or delaying hypoxemia (by measuring PaO2), and that this technique may be used to
      prevent morbidity and mortality in all clinical areas (not only in the Operating Room
      environment) where airway management is undertaken.
    

Intervention name(s): Nasal oxygen therapy
Intervention type(s): Other
Intervention description(s): Arm 1: Nasal cannulae with no oxygen flow. Arm 2: Nasal cannulae with oxygen flow at 5 L/min Arm 3: Nasal cannulae with oxygen flow at 10 L/min
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Apneic oxygenation; Apneic diffusion oxygenation