bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Pharmacists Role in the Management of Hypertension in Jordan
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Background: studies have demonstrated the crucial role of clinical pharmacists as integrated
      part of heath care team. Not only in Jordan but also in the Middle East region, clinical
      pharmacy practice is not well established. This current study is the first to evaluate
      physicians - pharmacists' collaborative approach to uncontrolled blood pressure in Jordan and
      the Middle East.
    

Detailed description: 
      Objective: this study aimed to evaluate clinical pharmacists' role in the management of
      uncontrolled hypertensive patients in Jordan. Design: single blinded randomized controlled
      clinical trial. Patients: 253 patients with uncontrolled hypertension specified as higher
      blood pressure readings than the recommended goals by the seventh report of the Joint
      National Committee on prevention, detection, evaluation, and treatment of high blood pressure
      (JNC VII) at the time of enrollment.

      Interventions: patients were randomly allocated to an intervention or control group: 130 and
      123 patients, respectively. Patients in both arms were followed up for 6 months. In the
      intervention group, patients were managed by physician-clinical pharmacist team. In the
      control group, patients were managed by physician(s) only and were not provided
      pharmaceutical care services.
    

Intervention name(s): pharmaceutical care services
Intervention type(s): Other
Intervention description(s): Patients treatment related problems and therapeutic needs or complains identified by clinical pharmacist and managed collaboratively by both pharmacist and the physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Uncontrolled blood pressure
Probiotic Supplementation in the Term Newborns Delivered by Caesarean Section
Condition: Microbiota, Cesarean Section, Probiotics, Dysbiosis
MeSH terms: Dysbiosis
Study type: Interventional

Summary: 
      Objectives: The gut microbiota plays pivotal role in the maintenance of human health. There
      are numerous factors, including the mode of delivery, that impact early gut colonization.
      Recent research focuses on probiotics' use in prophylaxy of gut dysbiosis in the newborns
      delivered by CS. We aimed to investigate whether a probiotic supplement in the newborns
      delivered by CS alter the pattern of gut colonization and has effect on decreasing risk of
      dysbiosis.

      Methods: a prospective, randomized trial with a control group. 150 newborns, born in 38-40
      gestational age, delivered by CS were included to the study. They were randomized into 2
      groups- interventional supplemented with the probiotic containing Bifidobacterium breve PB04
      i Lactobacillus rhamnosus KL53A (FFBaby, IBSS BioMed SA, Poland) and control. Stool samples
      were obtained on 5th and 6th day of life and after one month of life, and analyzed
      microbiologically in the lab. Bacterial colonies' genre and species were next identified and
      quantified.
    

Detailed description: 
      The aim of the study was to assess the effect of the probiotic supplementation on microbiota
      composition of the gut in healthy newborns delivered by CS. We studied colonization of GI
      tract on the day of discharge from hospital and after a month of life.

      It was a prospective, randomized trial with the control group, conducted in the Neonatal
      Clinic of the Jagiellonian University Hospital in Kraków, lasting from April 2014 to April
      2017.

      The patients we recruited were randomized into 2 groups- interventional or control group. In
      the interventional group we supplemented the probiotic containing Bifidobacterium breve PB04
      i Lactobacillus rhamnosus KL53A (FFBaby, IBSS BioMed SA, Poland) orally during the first hour
      of life and after 12 hours in mother's milk or formula (the total amount of the probiotic was
      2 x 10 6 CFU bacteria).

      The permission for the clinical trial was granted by the regional medical Bioethical
      Committee of the Jagiellonian University. (The number of decision- KBET/46/B/2014 from the
      27th of March 2014)
    

Intervention name(s): containing Bifidobacterium breve PB04, Lactobacillus rhamnosus KL53A
Intervention type(s): Dietary Supplement
Intervention description(s): we supplemented the probiotic orally during the first hour of life and after 12 hours in mother's milk or formula (the total amount of the probiotic was 2 x 10 6 CFU bacteria).
Other intervention name(s): FFBaby
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients we recruited were randomized into 2 groups- interventional or control group. For comparison we examined the stool samples of 32 healthy newborns delivered vaginally
Masking: None (Open Label)
Primary purpose: Prevention
Pilot Study Assessing Oxidative Stress in Children
Condition: Adrenal Insufficiency; Critical Illness
MeSH terms: Adrenal Insufficiency; Critical Illness
Study type: Observational

Summary: 
      Role fo oxidative stress in adrenal insufficiency has not been studied. The degree of
      oxidative stress and it's role in pediatric critical illness is unknown. Potential for
      significant alterations to many of thew body's regulatory pathways may result from severe
      oxidative stress. Further is needed to delineate what if any role oxidative stress may play
    

Detailed description: 
      Adrenal insufficiency (AI) is common in critically ill children and adults. AI is a condition
      in which the adrenal glands, located above the kidneys, do not make enough hormones or our
      body is unable to use the hormones made. A hormone is a chemical that helps control different
      kinds of body functions. The hormones being studied can influence blood pressure and how fast
      the heart beats. Doctors want to know why children need extra hormones when they are
      critically ill. In our pediatric intensive care unit (PICU) we treat AI with a set of
      standard orders. By doing this, we have shown that AI is common in many types of sickness and
      that blood pressure improves when extra hormones are given. We also found that people's heart
      and blood pressure did not always match the level of a certain hormone, called cortisol, in
      their blood.

      Since cortisol levels alone don't always show AI, and children with normal hormone levels
      still benefit from steroids, doctors are looking for a better understanding of AI. Finding
      reasons that children develop AI may help doctors find other ways to improve AI.

      One promising focus of AI is the role of oxidative stress (OS). OS is a term used to describe
      a group of chemical reactions that involve oxygen. Emory's adult intensive care units have
      shown a significant increase in OS in critically ill patients. Normally our body's cortisol
      acts by binding to glucocorticoid (a class of hormone) receptors (GR) within cells. Many
      studies have shown that OS increases steroid resistance by changing the GR structure and
      function. Studies involving OS and GR problems have not been done with children.

      We aim to:

        1. Find out how many sick children have OS in the PICU.

        2. Find out the normal OS level of healthy children.

        3. Decide if OS causes adrenal insufficiency.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population 1 consists of critically ill patients being care for in quaternary PICU.

        Population 2 consists of relatively healthy children undergoing MRI for sedation
      
Biospecimen description: 
      Serum from critically ill patients
    
Keywords: Biological Response Modifiers; Endocrinology; Hormone Dysfunction; Hormones; Neuroendocrinology
Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are (1) to determine the efficacy of fecal microbiota
      transplantation (FMT), given as oral capsules, compared with placebo for the treatment of
      refractory diarrhea-predominant irritable bowel syndrome (IBS-D); (2) determine the impact of
      FMT on the intestinal microbiome of patients with IBS-D; and (3) assess the safety,
      feasibility, and tolerability of FMT for patients with IBS-D.
    

Detailed description: 
      This is a multicenter study including Montefiore Medical Center, Concorde Medical Group PLLC
      and the Medical Research Center of Connecticut/Yale-New Haven Hospital Langone Medical
      Center. Patients with IBS-D will be recruited from outpatient gastroenterology clinics at
      these institutions and referrals from the medical community.

      FMT capsules and placebo capsules, provided by OpenBiome, Medford, MA, will be used for this
      study. Patients will be randomized to undergo FMT using fecal capsules (experimental group)
      or placebo capsules (control group) via a computer-generated program. All patients will
      cross-over into the alternate arm of the study at 12 weeks. Therefore, all patients enrolled
      will receive the experimental drug during the course of the study. Each patient will be
      enrolled in the study for a total of 6 months.

      Intestinal microbiome analyses using DNA sequencing and non-cultivation-based approaches (16S
      DNA technology) will be performed in all patients in the experimental and control groups to
      assess stability of the microbiome over time.
    

Intervention name(s): Fecal microbiota transplantation capsules; Placebo capsules
Intervention type(s): Drug; Drug
Intervention description(s): Fecal microbiota transplantation capsules contain extensively screened donor stool and are prepared by OpenBiome, Medford, MA.; Placebo capsules prepared by OpenBiome, Medford, MA
Other intervention name(s): FMT oral capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fecal microbiota transplantation; diarrhea-predominant
Effect of Neomycin on the Pharmacokinetics of Regorafenib
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of neomycin on the pharmacokinetics (PK) of regorafenib in healthy
      male subjects
    


Intervention name(s): Regorafenib (Stivarga, BAY73-4506); Neomycin
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose (s.d.) 160 mg (four 40 mg tablets) of regorafenib on two occasions (Day 1, Period 1, and Day 1, Period 2) separated by a washout period of at least 14 days; 1 g tid (three times a day) regimen of Neomycin (oral) on five days in Period 2 starting 4 days before regorafenib intake on day 1 in period 2.
Intervention MeSH terms: Neomycin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Regorafenib; Neomycin; Cancer; Pharmacokinetics; Safety
ANAVEX2-73 Study in Patients With Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      ANAVEX2-73-RS-002 is a Phase 3, double-blind, randomized, placebo-controlled dose escalation
      safety, tolerability and efficacy study in patients 18 years and older with RTT using
      endpoints including multiple clinical and exploratory molecular and biochemical measures.
    

Detailed description: 
      This Phase 3 safety, tolerability and efficacy study is designed as a double-blind,
      randomized, placebo-controlled study.

      This is a 7-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of
      patients with RTT 18 years or older. A voluntary option will be offered for all patients to
      continue a 48-week open label extension.
    

Intervention name(s): ANAVEX2-73; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liquid oral solution; Liquid oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 36 participants: 3 PK open-label followed by 33 double-blind, randomized, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Proprioceptive Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis
Condition: Thumb Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Objective: To establish the effectiveness of a proprioceptive training program as a
      complementary therapy for a traditional protocol in position control, pain intensity, upper
      limb function and occupation performance for patients with thumb CMC joint OA.

      Methods: Standard conservative thumb CMC joint OA treatments were received for both the
      control (n=26) and experimental groups (n=26) for a period of 12 weeks. The experimental
      group received a proprioceptive training program during the same intervention period, which
      was conducted twice weekly (24 sessions). The severity of pain with activity was measured
      according to the visual analog scale (VAS). QuickDASH questionnaire was used to measure upper
      extremity function. Patient's occupational performance was measured with the Canadian
      Occupational Performance Measure (COPM) and proprioception was assessed using Joint position
      sense (JPS) testing.
    


Intervention name(s): Proprioception exercises; Joint protection program; Thumb orthosis; Manual distraction
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Exercises for recognition of thumb position and thumb force sense.; Reeducation in the activities daily life; Thumb night orthosis; Manual distraction of CMC joint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thumb pain; Thumb proprioception; Thumb Osteoarthritis
A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, randomized, two way crossover study to investigate the
      food effect on the pharmacokinetics of ACT-541468 in healthy male subjects.
    


Intervention name(s): ACT-541468
Intervention type(s): Drug
Intervention description(s): ACT-541468 50 mg film-coated tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two way crossover
Masking: None (Open Label)
Primary purpose: Other
The Noninvasive Ventilation to COVID-19 Patients
Condition: Noninvavie Ventilation to Patients With COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Noninvasive ventilation(NIV) is an important treatment to the respiratory failure
      patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory
      failure.The NIV may reduce the intubtion rate.This research was taken to investigate the
      factor to the success of the noninvasive ventilation to the COVID-19 patients with
      respiratory failure.
    

Detailed description: 
      Noninvasive ventilation(NIV) is an important treatment to the respiratory failure
      patients.The severe Corona Virus Disease-19(COVID-19) patients are incline to respiratory
      failure.The NIV may reduce the intubtion rate.This research was taken to investigate the
      factor to the success of the noninvasive ventilation to the COVID-19 patients with
      respiratory failure.We wish to raise the success rate to COVID-19 patients with respiratory
      failure.More critically ill COVID-19 patients could avoid the intubtion.
    

Intervention name(s): noninvasive ventilation
Intervention type(s): Device
Intervention description(s): noninvasive ventilation to support the COVID-19 patients with respiratory failure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        respiratory failure patients with COVID-19
      
Keywords: noninvavie ventilation; COVID-19; respiratory failure
The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      BMS-986165 Is broken down by the body through multiple pathways. This study Investigates the
      effect of blocking one pathway in the drug levels of BMS-986165 in health subjects.
    


Intervention name(s): BMS-986165; diflunisal
Intervention type(s): Drug; Drug
Intervention description(s): Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Diflunisal; Deucravacitinib
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Behavioral Health Intervention Using Digital Technology in Radiation Therapy for Prostate Cancer Patients
Condition: Prostate Cancer; Prostate Adenocarcinoma; Radiation Toxicity
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine how to incorporate a smart water bottle to improve
      bladder filling for prostate cancer patients undergoing radiation therapy.
    


Intervention name(s): Smart Water Bottle
Intervention type(s): Behavioral
Intervention description(s): Patients will be given a smart water bottle and coached on its use. The device is a 24 oz non-bisphenol A acrylic water bottle with the ability to track water consumption from the bottle, alert its users via a smartphone-based notification system, as well as visually remind patients with a light-emitting diode in the device. Participants will be alerted to drink patient-specific volumes of room temperature water 45 minutes prior to daily standard of care radiotherapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Comparison of Screw and Suture Button Technique Results in Ankle Syndesmosis Injuries
Condition: Ankle Injuries; Syndesmotic Injuries; Tibiofibular; Dislocation Distal
MeSH terms: Wounds and Injuries; Ankle Injuries
Study type: Observational

Summary: 
      In this study, syndesmosis injuries were detected in 143 of the patients who came to Atatürk
      University Faculty of Medicine, Orthopedics and Traumatology clinic from October 2017 to
      October 2021 with ankle fractures. 33 of these patients couldn't followed for various
      reasons. Screw or suture buttone method was applied on 110 patients. And patients were
      examined with lots of data to compare their results. A retrospective study was conducted.
    


Intervention name(s): Screw fixation; Suture button
Intervention type(s): Device; Device
Intervention description(s): Screw fixation to patients; Suture button for patients
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Comparison of 110 patients with screw or suture button method.
A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the safety and efficacy of varenicline given
      for a twelve week treatment period in comparison with placebo for smoking cessation.
    


Intervention name(s): varenicline
Intervention type(s): Drug
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat
Condition: Lipodystrophy; Cellulitis; Adiposity
MeSH terms: Cellulitis; Lipodystrophy
Study type: Interventional

Summary: 
      PURPOSE: To evaluate the efficacy of shock waves extracorporea in improving body
      contour,decrease fat localized and appearance of gynoid lipodystrophy.

      SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be
      performed in 30 women with localized fat and gynoid lipodystrophy. Patients will be submitted
      data collection and assessments and before and after treatment.

      HYPOTHESES: It is expected that the patients will present improvement in the body contour,
      decrease fat localized and in the picture of the gynoid lipodystrophy after of the therapies.

      STATISTICAL ANALYSIS: A descriptive analysis will be done before and after
      vibration-oscillatory therapy, with frequency tables for categorical and descriptive
      variables (mean, standard deviation, median, minimum and maximum values) for continuous or
      numerical variables. In order to compare the main variables between the groups and the
      collection times, the analysis of variance (ANOVA) for repeated measurements will be used.
      Tukey's test will be used to compare groups. The level of significance adopted for the
      statistical tests will be 5% or p <0.05.
    

Detailed description: 
      After signing the informed consent, the participants will be evaluated by two
      physiotherapists where the data collected will be personal data, anthropometrics and
      complementary diagnostic tests, such as: ultrasound diagnosis to evaluate the thickness of
      the adipose tissue and Cutomiter analysis of the Viscoelasticity of skin. They then started
      treatment with another physiotherapist who will perform the following study protocol: placing
      a light layer of neutral gel on the treatment area, applying extracorporeal shock waves with
      the stainless steel tip with 180mJ of energy totaling 4 thousand shots , in abdomens,
      buttocks and posterior thigh and 2 thousand shots in flanks, then performs the change of the
      tip to the plastic and performs 2 thousand shots in the regions of abdomens, buttocks,
      posterior thigh emil shots in the region of flanks. The protocol will be performed twice a
      week for 1 and 20 hours each, totaling 10 sessions.
    

Intervention name(s): THORK Shock Wave® (Extracorporeal shock waves)
Intervention type(s): Device
Intervention description(s): Treatment with extracorporeal shock waves: energy between 100 and 180mJ, frequency of 15Hz and 6000 shots in abdomen, glutes and thigh Back and flanks 3000 shots with radial applicator and 15mm tip. The treatment is performed twice a week for 1 hour and 30 minutes each session.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shock wave; Gynoid lipodystrophy; Cellulits