bioihbjkbjnl/mcl2 huggingface dataset:
Effect of 4-session Metacognitive Training in Chinese Adult Outpatients With Schizophrenia Spectrum Disorders and Major Depressive Disorder
Condition: Delusions; Depression
MeSH terms: Depression; Depressive Disorder; Schizophrenia; Depressive Disorder, Major; Delusions
Study type: Interventional

Summary: 
      Psychological studies have shown that individuals tend to attribute causes of positive and
      negative events differently. Specifically, individuals hold an internalising or externalising
      bias of attribution which, in the case of particular patient groups, was found to polarize to
      the extreme. Such extreme attributional styles have found to have a direct impact on
      emotions, leading to a waning course of psychiatric disorders. This project aims to further
      examine the theoretical links between attributions and emotions using a transdiagnostic
      approach, and the effect of a 4-session process-based intervention on attributional biases.
    


Intervention name(s): Metacognitive Training
Intervention type(s): Other
Intervention description(s): 4 sessions of Metacognitive Training using 4 treatment modules each targeting different cognitive biases
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psychosis; Depression; Metacognition; Attribution; Emotions
The Cognitive Effects of 'Brainwaves' Supplementation in Cognitively Intact Older Adults
Condition: Cognitive Change; Mood Change; Microbial Colonization
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      This study investigated the effects of a proprietorial herbal supplement, Turmeric Brainwave
      (now Mind focus), on cognition, mood and the microbiome in older adults experiencing
      subjective memory decline, following 90 days supplementation.
    

Detailed description: 
      The primary aim of this randomised, double blind, placebo-controlled, parallel groups study
      was to assess the effects of a daily dose of Turmeric Brainwaves, versus placebo, both
      acutely and following 90 days consumption. Effects were to be assessed in 55-75 year old
      males and females who reported that their memory now was worse than when in their 20's.
      Effects were assessed via cognitive (including COMPASS and Cognimapp as well as 2 real-world
      long-term memory tasks (location-action (AKA Prospective Remembering Video Procedure (PRVP))
      and recall of facts)) and mood (using visual analogue scales) outcomes and, additionally,
      stool and urine samples collected at the beginning and the end of the trial period assessed
      the microfloral community of the gut and urinary metabolome.
    

Intervention name(s): Turmeric Brainwave
Intervention type(s): Dietary Supplement
Intervention description(s): A multiingredient herbal supplement with Turmeric as its most abundant single ingredient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Turmeric; Cognition; Microbiome; Metabolome
Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      A prospective randomized trial to compare the safety and efficacy of the Ex-PRESS to
      trabeculectomy in patients with open angle glaucoma who failed medical or are allergic to
      medical treatment and for which filtering surgery is indicated. Surgical success was defined
      as 5 mmHg ≤ intraocular pressure ≤ 18 mmHg, with or without medications, without further
      glaucoma surgery. Postoperative intraocular pressure, number of medications, complications
      and success rates were followed for 2 years.
    


Intervention name(s): Trabeculectomy; Ex-PRESS mini shunt
Intervention type(s): Procedure; Device
Intervention description(s): Standard trabeculectomy procedure
Creation of a fornix or limbal based conjunctival flap in upper quadrants
Creation of a limbal-based scleral flap extending into clear cornea
Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
Creation of fistula 1mm x 2mm in size
Iridectomy
Suturing the scleral flap
Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged.; Ex-PRESS implantation procedure:
Creation of a fornix or limbal based conjunctival flap in upper quadrants
Creation of limbal-based scleral flap extending into clear cornea
Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus
Prior to implantation, a thorough mobility check should be performed
Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision
Withdrawal of introducer
Tucking plate under the scleral flap, and verification of its position
Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad - patient is discharged.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ex-PRESS; TRABECULECTOMY
Adult Stem Cell Therapy in Liver Insufficiency
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Hepatic Insufficiency; Liver Failure
Study type: Interventional

Summary: 
      In order to determine the clinical application potential of adult stem cells we propose to
      investigate the safety and toxicity of infusing adult stem cells in the hepatic artery or
      portal vein of five patients with chronic liver insufficiency and to identify any clinical
      benefit if such occurs.

      Objectives:

        1. To assess safety and treatment related toxicities

        2. To determine clinical benefit or deterioration by monitoring changes in liver function
    

Detailed description: 
      The liver in an adult healthy body maintains a balance between cell gain and cell loss.
      Though normally proliferatively quiescent, hepatocyte loss such as that caused by partial
      hepatectomy, uncomplicated by virus infection or inflammation, invokes a rapid regenerative
      response to restore liver mass. This restoration of moderate cell loss and 'wear and tear'
      renewal is largely achieved by hepatocyte self-replication. More severe liver injury can
      activate a potential stem cell compartment located within the intrahepatic biliary tree,
      giving rise to cords of bipotential, so-called, oval cells within the lobules that can
      differentiate into hepatocytes and biliary epithelial cells. A third population of stem cells
      with hepatic potential reside in the bone marrow; these haematopoietic stem cells can
      contribute to the albeit low renewal rate of hepatocytes, make a more significant
      contribution to regeneration and even completely restore normal function in a murine model of
      hereditary tyrosinaemia.

      A recent abstract has suggested that an astonishingly high number of bone marrow cells (~25%
      of liver parenchyma occupied by bone marrow-derived cells) will engraft and differentiate
      into hepatocytes in a model of cirrhosis in the mouse when injected intravenously. More
      importantly, this bone marrow infusion resulted in significant improvements in liver function
      (serum albumin) within the cirrhotic animals.

      This is a safety and toxicity study in five patients with chronic liver disease. Each will
      receive autologous stem cells 10 to the sixth cells via the hepatic artery or portal vein
      under image guided scanning. Patients will be followed for a total of 60 days.
    

Intervention name(s): Leukapheresis; Infusion of stem cells via image guided scan
Intervention type(s): Procedure; Procedure
Intervention model: Single Group Assignment
Intervention model description: Autologous stem cells
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult stem cells; Liver disease; CD34 positive cells
A New Concept in the Tip Plasty of Asian Rhinoplasty
Condition: Asian Rhinoplasty
Study type: Interventional

Summary: 
      For achieving the desired refinements in Asian patients, sufficient septal cartilage must be
      needed for the ieal tip projection and lengthening of the nose by the septal extension graft,
      columellar septal strut graft, and onlay tip graft, shield graft. Actually there are many
      cases having insufficient septal cartilages in Asian augmentation rhinoplasty.

      The investigators propose the new technique, so called 'Flag Technique' by a tip-strut
      complex in a flag-like shape : using only the septal cartilage as an elongated columellar
      septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the
      elongated columellar septal strut graft without the septal extension graft to achieve the
      desired the result.
    

Detailed description: 
      The investigators propose the new technique, so called 'Flag Technique' by a tip-strut
      complex in a flag-like shape : using only the septal cartilage as an elongated columellar
      septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the
      elongated columellar septal strut graft without the septal extension graft to achieve the
      desired the result.
    

Intervention name(s): The Flag Technique
Intervention type(s): Procedure
Intervention description(s): A New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage without Septal Extension Grafts
The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tip plasty; septal cartilage
Indirect Laryngoscopy and Ultrasonography in Prediction of Difficult Airway
Condition: Difficult Intubation
Study type: Observational

Summary: 
      This study was designed to assess the success of indirect laryngoscopy and ultrasonographic
      measurements in the prediction of difficult airway. All patients were examined by indirect
      laryngoscopy and ultrasonography preoperatively and the predictive values for difficult
      airway of these methods were compared.
    

Detailed description: 
      Difficult airway is a condition that increases the patient's vital risk and leaves the
      anesthesia and surgical team in a difficult position. Failure to perform an adequate
      preoperative evaluation may result in the team being unprepared. Therefore, various methods
      have been investigated in the prediction of difficult airway from past to present. With the
      development of technology, imaging methods have become routine applications in clinical use.
      Ultrasonography and indirect laryngoscopy have been shown to be used in predicting difficult
      airway in the literature, but there is no study showing which is a better predictor.
    

Intervention name(s): Ultrasonographic upper airway measurements
Intervention type(s): Diagnostic Test
Intervention description(s): Ultrasonographic upper airway measurements: Epiglottis-skin distance, Hyoid bone-skin distance, Anterior commissure-skin distance and Thickness of tounge root.
Indirect Laryngoscopy: Grading of laryngoscopic view (I=Visible anterior commissure and vocal cords, II= visible posterior part of vocal cords and posterior commissure, III= Visible posterior commissure and epiglottis, IV= Visible only epiglottis tip and posterior pharyngeal wall)
Other intervention name(s): Indirect Laryngoscopy
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The patients who apply to ear, nose and throat department for any kind of
        otorhinolaryngological operation are included into the study.
      
Keywords: airway; laryngoscopy; ultrasonography
A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-391
    

Detailed description: 
      A phase I clinical trial to compare and evaluate the safety and pharmacokinetic
      characteristics after administration of CKD-391 and co-administration of CKD-331 and D337 in
      healthy adult volunteers
    

Intervention name(s): Drug: CKD-391, QD, PO
Intervention type(s): Drug
Intervention description(s): Drug: CKD-331, D337 QD, PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD-391
Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer
Condition: Control Media Only; Study hCG and Media
Study type: Interventional

Summary: 
      Techniques to improve pregnancy and delivery rates in IVF cycles have focused not only on the
      embryos transferred, but also the conditions in the uterus at the time of transfer and
      implantation. Prior studies have shown that embryos secrete human chorionic gonadotropin
      (hCG) prior to implantation. However, in IVF cycles, the embryos have limited time to secrete
      hCG before implantation must occur because embryos are placed into the uterus rather than
      traveling there from the fallopian tubes. Recent studies have shown that the introduction of
      hCG into the uterus prior to embryo transfer may make the uterus more receptive to
      implantation. These studies involved day 3 embryos and the investigators are seeking to
      evaluate the potential benefits of hCG on implantation rates of blastocysts (day 5 or day 6
      embryos).

      The purpose of this study is to determine whether infusion of human chorionic gonadotropin
      (hCG) into the uterus immediately prior to embryo transfer results in increased implantation
      rates.

      The entire IVF cycle, fresh or frozen, will be conducted per routine. All laboratory culture
      conditions will be per routine. In fresh and frozen IVF cycles, an embryo transfer will be
      performed per routine.

      At the time of embryo transfer, participants will be randomly assigned to either the control
      group or the hCG group. Patients in the hCG group will have a mock embryo transfer with 20µL
      of transfer media including 500IU of hCG. Patients in the control group will have a mock
      embryo transfer with 20µL of transfer media.

      All post-transfer care and pregnancy monitoring will be identical and per routine protocol.
    


Intervention name(s): hCG at the Time of Embryo Transfer; Control
Intervention type(s): Other; Other
Intervention description(s): hCG will be included in the 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.; Patients will have 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVF; embryo
Early Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea
Condition: Acute Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which nutritional regime is better for acute
      diarrhea in outcomes.
    

Detailed description: 
      Diarrhea is still the most important cause of mortality and morbidity in children of the
      developing countries. We evaluated the effectiveness of early administration of lactose free
      milk in the management of acute diarrhea in children below two years old.
    

Intervention name(s): lactose-free milk; conventional milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): a milk without lactose; a milk with lactose
Other intervention name(s): nothing; nothing
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: diarrhea, lactose, milk, weight, acute.
A Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is looking at how five different formulations of faster aspart 200 U/mL reach and
      stay in the blood after injection. The purpose is to find a formulation that behaves
      similarly to the reference product called faster aspart 100 U/mL (marketed as Fiasp®). The
      participant will get all five formulations and the reference product. The order in which the
      participant gets them is decided by chance. The participant will get each medicine once
      during the study meaning that the participant will get a total of six injections with study
      medicine. The medicine will be injected under the skin in the stomach. The study will last
      for about 2 to 21 weeks depending on individual visit schedule. The participant will have
      nine clinic visits with the study doctor (including the one in which the participant give
      consent).
    


Intervention name(s): Faster Aspart 200 U/mL; Faster aspart 100 U/mL
Intervention type(s): Drug; Drug
Intervention description(s): A single dose (0.15 U/kg) of five formulations of fast-acting insulin aspart 200 U/mL (formulations A, B, C, D, E) in a sequential manner via subcutaneous injection.; A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.
Intervention MeSH terms: Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)
Condition: HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL)
MeSH terms: Lymphoma; Leukemia; Leukemia, T-Cell; Leukemia-Lymphoma, Adult T-Cell
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the safety of the combination of CHOP plus
      daclizumab in patients with ATLL previously untreated with anthracycline based chemotherapy.
    


Intervention name(s): CHOP-daclizumab
Intervention type(s): Drug
Other intervention name(s): CHOP-Zenapax
Intervention MeSH terms: Daclizumab
Primary purpose: Treatment
Study of Blood Samples From Patients With Ewing Sarcoma and Their Relatives
Condition: Sarcoma
MeSH terms: Sarcoma; Sarcoma, Ewing
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood in the laboratory from patients with cancer and their
      relatives may help doctors learn more about changes that occur in DNA and identify biomarkers
      related to cancer.

      PURPOSE: This research study is looking at blood samples collected from patients with Ewing
      sarcoma and their relatives.
    

Detailed description: 
      OBJECTIVES:

        -  To identify and characterize a genetic susceptibility factor to Ewing's sarcoma by
           performing a Genome-Wide Association Study with as many as possible Ewing sarcoma
           patients.

      OUTLINE: This is a multicenter study.

      Blood samples are collected from patients and their relatives. Blood DNA samples are analyzed
      for susceptibility genes of Ewing Sarcoma.
    

Intervention name(s): genome-wide association study
Intervention type(s): Other
Observational model: Family-Based
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Ewing's sarcoma, with idenfication of a specific translocation of Ewing's
        sarcoma
      
Keywords: Ewing sarcoma; Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)
The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage
Condition: High Risk Pregnant Women Undergoing Elective Cesarean Section
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to assess the prophylactic role of tranexamic acid in reducing blood
      loss during and after elective cesarean section delivery in high risk patients.

      Comparing effect of administration of 1gm of TXA half an hour before elective C-section ,
      effect of administration of 1gm of TXA on the start of uterine incision and placebo effect,
      Where in all an addition of prophylactic uterotonics is given, in a randomized control,
      double blind trial of 3 groups.
    

Detailed description: 
      All patients will undergo the following

      I. History : Medical history, Obstetric history, Comorbidities, Allergies. II. Clinically:
      Vital signs, Abdomino-pelvic examination, per-vaginal examination.

      III. Laboratory: Hemoglobin, Hematocrit before & after cesarean section. IV. Routine
      Ultrasound. V. Cesarean section: done under spinal anathesia.

      VI. Calculation of blood loss:

      The quantity of blood loss (ml) is calculated from 3 components :

        -  (weight of used towels during surgery - weight of used towels prior to surgery),plus

        -  (volume of blood sucked in suction container after placental delivery) ,plus

        -  (weight of used vaginal pad in the first 2 hours after CS - the pad' s dry weight)

        -  Each 1 mg increase the weight of either the towels or the vaginal pads is equivalent to
           1 ml blood loss (Vitello, Dominic J., et al).

      VII. Informed Consent: will be obtained from all participants including the pregnant women
      who are included in the study .

      All patients will receive routine ecbolics ( oxytocin ) after delivery of baby.
    

Intervention name(s): Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)
Intervention type(s): Drug
Intervention description(s): IV 1gm
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: high risk pregnancy; cesarean section.; tranexamic acid