bioihbjkbjnl/mcl2 huggingface dataset:
First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional
Phase: Phase 1

Summary: 
      The Bashir™ Endovascular Catheter is a device intended for the localized infusion of
      therapeutic agents into the pulmonary artery and peripheral vasculature.
    

Detailed description: 
      The Bashir™ Endovascular Catheter has been designed to administer therapeutic agents in the
      peripheral vasculature. Because of the unique design of the catheter, with its six expandable
      infusion limbs, the Bashir™ Endovascular Catheter has the ability to: 1. Create a much larger
      central channel for blood flow, thereby utilizing the body's own endogenous fibrinolytic
      agents to lyse the clot, and 2. Greatly enhance the radial dispersion of a
      catheter-administered thrombolytic agent throughout the thrombus. Expansion of the multiple
      arms of the basket in the infusion catheter causes fissuring of the clot. The net result is
      that a greater surface area of clot is exposed to both endogenous and exogenously
      administered lytic agents, thereby promoting clot dissolution.
    

Intervention name(s): r-tPA; The Bashir™ Endovascular Catheter
Intervention type(s): Drug; Device
Intervention description(s): Pulse spray and infusion; The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
Intervention model: Single Group Assignment
Intervention model description: Pulse Spray and Infusion of r-tPA
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Embolism
Tenofovir in Chronic Hepatitis B With Mild ALT Elevation
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to clarify whether patients with chronic hepatitis B with high viral load
      will benefit from oral antiviral therapy despite only mildly elevated serum liver enzyme.
    

Detailed description: 
      Chronic hepatitis B (CHB) is a serious disease in Taiwan, leading to substantial morbidity
      and mortality including hepatic failure, liver cirrhosis, and hepatocellular carcinoma (HCC).
      Recently a large body of evidence supports that high level of serum HBV DNA is an independent
      risk factor for late complications in CHB patients. Nucleos(t)ide analogues (NUC) are
      effective antiviral therapy that can potently inhibit replication of hepatitis B virus (HBV),
      and has been widely used in management of patients with CHB. Current practice guidelines
      recommend using serum alanine aminotransferase (ALT) > 2 times of the upper limit of normal
      (ULN) as the prerequisite to initiate antiviral therapy in compensated CHB patients without
      liver cirrhosis. However, serum ALT level does not exactly correlate with serum HBV DNA or
      liver tissue injury. Whether antiviral therapy improves outcomes of patients with slightly
      elevated ALT (i.e. 1-2 folds of ULN) remains unknown.
    

Intervention name(s): tenofovir disoproxil fumarate 300mg per day; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): tenofovir disoproxil fumarate 300mg per day for 3 years; Placebo, identical to TDF in appearance, once daily for 3years
Other intervention name(s): Viread® (Gilead Sciences Inc)
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: chronic hepatitis B; hepatitis B viral DNA; antiviral therapy; Tenofovir
Naltrexone and Patch for Smokers
Condition: Smoking
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of naltrexone, alone and combined with
      nicotine patch, on responses of smokers to smoking cues after 10 hours of tobacco
      deprivation. Smokers who are not seeking treatment will be assigned to one of six conditions:
      They will receive either 50 mg of naltrexone or a placebo pill, and also will wear a nicotine
      patch that has 0, 21, or 42 mg of nicotine during the tobacco deprivation period. Both the
      day before the medication and deprivation and at the end of 10 hours of deprivation all will
      be exposed to lit cigarette cues in the laboratory. Effects of the medications will be
      assessed on withdrawal measures, urge to smoke, psychophysiological measures, and the
      topography of smoking three test cigarettes. Studies such as these can help to identify
      potential interventions for tobacco cessation or withdrawal, and thereby could result in less
      suffering and mortality.
    


Intervention name(s): Naltrexone Hydrochloride; Transdermal Nicotine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naltrexone; Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Naltrexone; Nicotine patch; Tobacco dependence
Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function
Condition: Hot Flashes; Sleep Disorders
MeSH terms: Sleep Wake Disorders; Parasomnias; Hot Flashes
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg
      administered to a population of Brazilian women in a continuous combined regime for hormone
      replacement therapy.
    


Intervention name(s): Totelle®
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menopause; Sleep Disorder; Hot Flashes
Evaluation of Liver Fibrosis Staging With Acoustic Radiation Force Impulse Elastography
Condition: Chronic Liver Disease
MeSH terms: Liver Diseases; Liver Cirrhosis
Study type: Observational

Summary: 
      This is a prospective cohort Study for evaluation of liver fibrosis staging with acoustic
      radiation force impulse elastography in patients with chronic liver disease and healthy
      liver/kidney donors.
    

Detailed description: 
      A recent new method for liver fibrosis assessment based on similar technology to transient
      elastography is acoustic radiation force impulse (ARFI) imaging. ARFI has the advantages
      which can be conducted in parallel ways of measuring points in the patients with chronic
      liver disease when they underwent routine ultrasound examination. Thus, the aim of this study
      was to identify the normal range of ARFI velocity and assess the best cut-off value by
      recruiting healthy living liver and kidney donors.
    

Intervention name(s): Acoustic radiation force impulse imaging
Intervention type(s): Device
Intervention description(s): Acoustic radiation force impulse (ARFI) imaging were measured 10 times in each patient.The region of interest was chosen in an area where the normal liver parenchyma was at least 6 cm thick and free of large blood vessels was chosen. A measurement depth of 2 cm below the liver capsule was chosen to standardize the examination.
Other intervention name(s): ARFI imaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with chronic liver disease, Healthy liver and kidney donors
      
Keywords: ARFI imaging; normal values; chronic liver disease; liver donors; kidney donors
Low Dye Taping Technique Versus Robert Debre Method On Foot Posture And Range Of Motion In Children With Club Foot.
Condition: Club Foot
MeSH terms: Clubfoot; Talipes; Equinus Deformity; Foot Deformities
Study type: Interventional

Summary: 
      To Check the effects of the low dye taping technique versus the Robert Debre method on foot
      posture and range of motion in children with club feet.
    

Detailed description: 
      This study was a Randomized clinical trial. It was carried out in the physiotherapy
      department of children hospital Lahore,those patients were taken who had congenital
      clubfoot.40 patients were taken with the predetermined inclusive and exclusive criteria
      through non probability convenience sampling technique.All participants informed about the
      study,Group A received Low Dye taping Technique 2 times in a week for 6 weeks,while the group
      B received the Robert Debre Methpod daily 30 minutes session for total 6 weeks.Foot posture,
      range of motion and gait will be assessed by Demiglio bensahel and pirani scoring system with
      the help of goniometer and compared the results.Data analyzed by SPSS 25.0 statistical
      software. After checking the normality of data nonparametric tests applied to check the
      difference between and within the groups.
    

Intervention name(s): Low Dye Taping
Intervention type(s): Other
Intervention description(s): This second group also contains 20 participents.French functional method is similar to the Ponseti method. In this technique, the patient undergoes 30-minute daily session for 2 weeks and then twice a week until achieving foot correction. It consists of stretching of triceps surae to improve tibio-talar joint function. daily manipulations of the newborn's foot, stimulation and strenghtening of the muscles around the foot (particularly the peroneal muscles) and temporary immobilization of the foot with elastic and nonelastic adhesive taping so that the reduction achieved by.The average time of this method ranges between 6 to 8 weeks, with all the deformities being corrected apart from equinus. This method reports a 93% success rate
Other intervention name(s): Robert Debre Technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Low dye taping; Robert Debre tecnique
A Study to Assess the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Adult Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to assess the relative bioavailability and
      pharmacokinetics of ABBV-903 in healthy adult participants.
    


Intervention name(s): ABBV-903 Tablet Form 1; ABBV-903 Tablet Form 2
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablets; Oral Tablets
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ABBV-903; Healthy Volunteer
Efficacy of an Augmented Reality Application Developed for ACLs Training on the Knowledge and Skill Levels of Nurses
Condition: ACLs Learning
Study type: Interventional

Summary: 
      Background: Having Advanced Cardiac Life Support (ACLs) skills is essential for nurses.
      During the COVID-19 pandemic, augmented reality (AR) technologies were incorporated into
      medical education to increase learning motivation and accessibility.

      Objectives: To determine whether using augmented reality for educational applications can
      significantly improve first aid cart learning, learning motivation, cognitive load, and
      system usability among nurses in ACLs training of nurses.

      Design: The present study was a quasi-experiment study. Settings: The research setting was a
      medical center in southern Taiwan Participants: In total, 102 nurses completed the course,
      with 43 nurses in the AR group and 59 nurses in the control group.

      Methods: An ACLs cart training course was developed using augmented reality (AR) technologies
      in the first stage. However, the efficacy of the developed ACLs training course was
      evaluated.
    

Detailed description: 
      Application Augmented Reality for ACLs training of Registered Nurse
    

Intervention name(s): An ACLs cart training course was developed using augmented reality (AR) technologies
Intervention type(s): Device
Intervention description(s): The developed first aid cart learning system was applied to ACLs drills in a regular ACLs training program, and an AR group used this learning system to assist in their learning. The AR group scanned the dedicated AR marker using a mobile device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
The Effect of Intraoperative Tramadol on Postoperative Opioid
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Postoperative pain remains a very UNPLEASENTevent, particularly in morbidly obese patients
      that may be associated with obstructive sleep apnea. Bariatric surgery patients must get safe
      and efficient analgesia, which is essential given that up to 45 % of patients report
      substantial pain in the first two days following surgery. The study's purpose was to compare
      the efficacy and safety of combined tramadol with pethidine versus pethidine alone and to
      assess their impact on postoperative pethidine requirements after LSG for morbidly obese
      patients
    

Detailed description: 
      This multicenter cohort research included patients with morbid obesity who had LSG between
      January 2021 and December 2022. The patients included in the study were allocated to one of
      two treatment groups that were not randomized but the patients were categorized according to
      the time of surgery: Group A received Pethidine alone in the period between January 2021 and
      December 2021, while Group B got Tramadol with pethidine in the period between January 2022
      and December 2022. Doses were based on the patient's actual body weight.
    

Intervention name(s): Pethidine; Tramadol with pethidine
Intervention type(s): Drug; Drug
Intervention description(s): Group A received Pethidine alone in the period between January 2021 and December 2021; Group B got Tramadol with pethidine in the period between January 2022 and December 2022
Other intervention name(s): Group A; Group B
Intervention MeSH terms: Meperidine; Tramadol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A received Pethidine alone in the period between January 2021 and December 2021, while Group B got Tramadol with pethidine in the period between January 2022 and December 2022. Doses were based on the patient's actual body weight.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: laparoscopic sleeve gastrectomy; morbid obesity; postoperative pain; tramadol; pethidine
Expectant Versus Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
Condition: Pregnancy Complications
MeSH terms: Pregnancy Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      Compared the interest of one week expectancy vs immediate medical treatment in the taking
      care of the evacuation of the no evolutionary pregnancies before 13 GW.
    

Detailed description: 
      Randomized control trial comparing one week expectancy vs immediate medical treatment
      (mifepristone 200mg and misoprostol 400ug) in the taking care of the evacuation of the no
      evolutionary pregnancies before 13 GW.
    

Intervention name(s): MIFEPRISTONE 200 mg and misoprostol 400 µg
Intervention type(s): Drug
Intervention description(s): MIFEPRISTONE 200 mg and misoprostol 400 µg
Intervention MeSH terms: Misoprostol; Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pregnancy Complications
Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study the investigators had evaluated the effectiveness SILODOSIN (8 mg daily orally)
      in Benign prostatic Hyperplasia in comparison to Tamsulosin (0.4 mg daily orally) in a
      randomized controlled trial design. Study population would be patients attending Urology OPD
      of BSMMU Hospital, Dhaka. Target sample size will be 136 evaluable patients in each group
      (assuming dropout rate 20%), suffering from Benign prostatic Hyperplasia .Subjects would be
      observed for 1 week without any drug. At the end of 1 week, they would be randomly allocated
      to Silodosin or Tamsulosin and treatment continued for 12 weeks. Interim follow-up visits
      would be at 1,4 and 12 weeks. USG confirmation of BPH would be required for recruitment.
      Effectiveness of the drugs would be assessed by International Prostate Symptom score, a
      quality of life (QoL) assessment done by a 7-point scale. Prostate weight/volume
      determination by USG, Change in post voidal residual urine (PVR) by USG and Changes in peak
      urine flow rate by uroflowmetry. Safety would be assessed by following up vital signs,
      treatment emergent adverse events and routine laboratory tests for drug safety.
    

Detailed description: 
      Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms
      in elderly men. Selective α1-adrenergic antagonists are now ﬁrst-line drugs in the medical
      management of BPH. This Hospital based randomized controlled clinical study designed to
      evaluate the efficacy of the new α1-blocker silodosin in the treatment of symptomatic benign
      prostatic hyperplasia (BPH).Ambulatory patients of age between 50 to 70 years, who were
      diagnosed as benign prostatic hyperplasia, were divided into two groups after fulfilling
      selection criteria. After informed consent & random sampling by lottery, silodosin 8 mg was
      given to group A (study) & tamsulosin 0.4 mg was given to group B (control). Total 149
      patients were enrolled in this study but 8 patients were lost during follow up. Hence 141
      patients completed the study, during the period of June 2017 to August 2018.
    

Intervention name(s): Silodosin; Tamsulosin
Intervention type(s): Drug; Drug
Intervention description(s): Cap silodosin; Cap tamsulosin
Other intervention name(s): Rapasin; Uromax
Intervention MeSH terms: Tamsulosin; Silodosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Weight Loss and Dietary Protein Intake on Bone
Condition: Weight Loss; Bone Density
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to learn how the amount of protein during moderate weight loss
      influences bone health. We will also examine how two levels of protein intake affects diet
      quality.
    

Detailed description: 
      It is unclear whether protein intake during dieting influences bone density. This information
      is important for determining optimal nutrient requirements during weight loss. This study
      will compare the effects of weight loss with a lower-carbohydrate, high-protein (HP) diet to
      a high-carbohydrate, moderate protein (HC) diet on bone mass and quality in postmenopausal
      women (ages 50-70 years) with the hypothesis that bone turnover and loss of bone will be
      reduced on the HP compared to the HC weight loss diet. In a secondary aim, we will examine
      bone markers, hormones and the impact of protein intake on diet quality.

      Participants will be randomly assigned to one of 2 groups: A) weight loss with recommended
      level of protein intake, and B) weight loss with higher protein intake. All participants will
      attend regular counseling sessions (about 50 minutes per session) with a dietitian for
      approximately 1 year, and will be asked to take a daily vitamin/mineral supplement. Also,
      depending on their usual food intake, they may be asked to take a calcium tablet to meet the
      recommended intake throughout the study period. Bone, mineral, protein and lipid markers, and
      hormones that influence bones will be measured. These measurements will provide information
      about body composition (fat, muscle mass, and bone mineral density). Participants will be
      asked to attend 8 diet counseling sessions, with the opportunity to attend a total of
      approximately 28 diet counseling sessions during the year.
    

Intervention name(s): Caloric restriction, high protein; Caloric restriction; normal protein; Counseling
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Weight loss with higher protein (35%) intake; Weight loss with recommended level of protein (18%)intake; Participants will be asked to attend eight 50-minute diet counseling sessions, with the opportunity to attend a total of approximately 28 diet counseling sessions, during the year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bone mass; calcium absorption; bone quality; fracture risk
Study on the Safety of BAY1817080 How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given to Participants With Moderate Renal Impairment and End Stage Renal Disease Requiring Dialysis Compared With Matched Participants With Normal Renal Function
Condition: Endometriosis Related Pain; Overactive Bladder; Diabetic Neuropathic Pain; Refractory or Unexplained Chronic Cough
MeSH terms: Neuralgia; Endometriosis; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      BAY1817080 is currently under clinical development to treat pain related to unexplained
      chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained
      chronic cough, RUCC), or a condition where the bladder is unable to hold urine normally
      (overactive bladder, OAB) or a condition in which tissue similar to the tissue that normally
      lines the inside of the womb grows outside the womb (endometriosis). Especially in elderly
      patients with OAB or RUCC, renal impairment is frequent. Renal impairment which co-occurs in
      especially in elderly patients with OAB or RUCC is a common condition in which the kidneys
      are not filtering the blood as well as they should. End stage renal disease (ESRD) requiring
      hemodialysis is a condition in which patients kidneys are no longer able to work as they
      should and require treatment to filter wastes from the blood. The goal of the study is to
      learn more about the safety of BAY1817080, how it is tolerated and the way the body absorbs,
      distributes and excretes the study drug given in men and women with moderate renal impairment
      and with those who have end stage renal disease (ESRD) requiring dialysis compared with
      matched participants with normal kidney function.
    


Intervention name(s): BAY1817080
Intervention type(s): Drug
Intervention description(s): BAY1817080 will be administered orally as tablet.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Normal renal function; Moderate renal impairment; End stage renal disease (ESRD); Dialysis