bioihbjkbjnl/mcl2 huggingface dataset:
A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care
Condition: Type 2 Diabetes; Major Depressive Disorder
MeSH terms: Diabetes Mellitus; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The study involves a 32-week randomized controlled trial in primary care of a comprehensive
      diabetic and depression intervention in patients with type 2 diabetes and comorbid MDD,
      compared to a group treated with usual care for MDD plus disease self-management and
      measurement-based care for diabetes.
    

Detailed description: 
      The overarching goal of the study is to translate research-based treatment procedures that
      have been shown to improve outcomes for both DM and MDD for use in primary care. More
      specifically, the aims are: 1) to evaluate the benefits of CDDI in improving diabetic
      outcomes compared to usual care for MDD plus disease self-management for diabetes; 2) to
      evaluate the benefits of CDDI in improving depression outcomes compared to the UC for MDD
      treatment protocol; and 3) to evaluate the benefits of CDDI in terms of improved (1)
      cardiovascular risk factors (blood pressure, body mass index, lipids, and abdominal fat), (2)
      levels of exercise and better diet, (3) clinician and patient satisfaction with care, (4)
      fidelity to treatment guidelines, and (5) cognitive function.
    

Intervention name(s): Diabetes and depression intervention; Diabetes intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Disease self management for diabetes and depression; Disease self management for diabetes
Other intervention name(s): Measurement based care; Disease self management; Measurement based care; Disease self management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Depression; Disease Self Management; Measurement Based Care
Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal
      guardian had provided signed informed consent, and who had satisfied the inclusion and
      exclusion criteria of the study.
    


Intervention name(s): Sodium Ferric Gluconate Complex in Sucrose.
Intervention type(s): Drug
Intervention MeSH terms: Ferric gluconate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anemia
Genetic Influences on Dental Maturation: A Twin Study
Condition: Dental Age Estimation Methods
Study type: Observational [Patient Registry]

Summary: 
      The genetics has been shown as one of the most important factor influencing the growth and
      development of the dentofacial complex. Dental development, one of the most reliable
      indicators of chronological age (CA), has been believed to be fundamentally influenced by
      genetics rather than environmental factors. As twins share genetic variation (100% for
      monozygotic and 50% for dizygotic twins) and were subjected to the similar environmental
      factors, the twin studies have been presented useful and effective method to researchers for
      investigating the influence of heredity on dental development and observing the similarities
      and differences among twin pairs.

      Evaluation of dental development is among the most commonly used and reliable method for
      dental age determination using the morphological parameters of teeth on dental radiographs.
      Dental maturity, defined as a dental age (DA), is very important in forensic anthropology to
      identify cases and in dentistry for planning pedodontic and orthodontic treatment, and also
      determining a child's growth and developmental status.

      There are many dental age estimation methods which are mostly based on the morphological
      evaluation of dental growth observed from dental radiographs in children In order to estimate
      dental age, Demirjian's, Willems' and Nolla's methods were used. All panoramic radiographs
      were scored by one observer to eliminate the inter-observer error.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A total of MZ and DZ pairs between the ages of 5.0 and 12.9 who attended to the Department
        of Pedodontics at Suleyman Demirel University and underwent radiological examination for
        any dental reason during the dental treatment period from January 2018 to January 2021
The Role of Periodic Alveolar Recruitment Maneuvers in Intraoperative Protective Ventilation
Condition: Mechanical Power; Alveolar Recruitment Maneuvers; Protective Ventilation; Postoperative Pulmonary Complications
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare three open-lung strategies on respiratory
      function and lung injury in protective ventilation for laparoscopic anterior resection. It
      aims to answer whether a periodic alveolar recruitment maneuvers (PARM) strategy alone was an
      appropriate open-lung strategy in intraoperative protective ventilation. Patients were
      randomly assigned (1:1:1) to receive one of three open-lung strategies in protective
      ventilation: PARM alone (alveolar recruitment maneuvers [ARM] repeated every 30 min),
      positive end-expiratory pressure (PEEP) alone (a PEEP of 6 to 8 cm H2O), or a combination of
      PEEP and PARM (a PEEP of 6 to 8 cm H2O combined with ARM repeated every 30 min). The primary
      outcome is the mechanical power before the end of intraoperative mechanical ventilation.
      Secondary outcomes included the accumulative intraoperative mechanical power, an arterial
      partial pressure of oxygen (PaO2) / inhaled oxygen concentration (FiO2) ratio (P/F ratio)
      before the end of intraoperative mechanical ventilation, the rates of respiratory failure at
      post-anesthesia care unit (PACU) and three postoperative days, the concentration of soluble
      advanced glycation end products receptor (sRAGE) and Clara cell protein 16 (CC16) at the end
      of surgery, postoperative pulmonary complications score, postoperative hospitalization days
      and so on.
    


Intervention name(s): periodic alveolar recruitment maneuvers; positive end-expiratory pressure
Intervention type(s): Other; Other
Intervention description(s): A stepwise increment of tidal volume was used for each ARM.; a PEEP of 6 to 8 cm H2O
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Class iv Versus Class Iiib Laser Therapy on Median Sternotomy Healing After Coronary Artery Bybass Graft
Condition: Wound; Wound Heal; Wound Infection
MeSH terms: Wound Infection; Wounds and Injuries
Study type: Interventional

Summary: 
      LASER therapy is potent physiotherapy modalities, providing better sternotomy healing for
      patients who have undergone CABG surgery, compared with traditional wound care management
      alone. HLLT and LLLT were found to be the most effective methods for sternotomy healing
      post-CABG surgery, with HLLT offering superior performance in the case of the high deep
      penetration and significance less time needed to deliver the same joules/ cm compared to LLLT
      used for the wound site.
    

Detailed description: 
      The aim of this study was to investigate the effects of class IV high-level laser therapy
      (HLLT) versus class IIIb low level laser therapy (LLLT) on sternotomy healing following
      coronary artery bypass grafting (CABG) surgery. Forty- five patients male patients who had
      CABG surgery in the age range of 45-65 years were divided randomly into three equal groups (n
      = 15). The group HLLT laser received HLLT plus traditional wound management, while the group
      LLLT laser received LLLT plus traditional wound management. The control group only received a
      traditional wound management in form of saline irrigation, dressing, and topical bivatracin
      spray according to hospital protocol. All groups were offered 10 sessions over 4 weeks. HLLT
      and LLLT were found to be the most effective methods for sternotomy healing post-CABG
      surgery, with HLLT offering superior performance in the case of the high deep penetration and
      significance less time needed to deliver the same joules/ cm compared to LLLT used for the
      wound site.
    

Intervention name(s): laser therapy for wound management
Intervention type(s): Device
Intervention description(s): comparison between laser effect on post median sternotomy incision compared to traditional wound care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: group A receive laser therapy class IV+traditional wound care and group (B): Laser therapy class IIIb + traditional wound care and group C receive only traditional wound care
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary arteries bypass grafting; high level laser therapy; Low-level laser therapy; Median sternotomy healing
Desmopressin Melt: Impact on Sleep and Daytime Functioning
Condition: Monosymptomatic Nocturnal Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional
Phase: Phase 4

Summary: 
      Nocturnal enuresis affects 10% of the 7-year-old children and is essentially caused by a
      mismatch between nocturnal bladder capacity and the amount of urine produced during the night
      together with failure of the child to awaken in response to a full bladder.Urine
      overproduction at night or nocturnal polyuria (NP) is a major factor contributing to
      monosymptomatic nocturnal enuresis (MNE) pathophysiology in a large proportion of patients.

      Since NP is related to an abnormal circadian rhythm of arginine vasopressin (AVP) secretion,
      the synthetic AVP analogue desmopressin is widely used to treat MNE.

      It is recommended by the International Consultation on Incontinence (grade A,level 1).
      Desmopressin is available in 3 different formulations: nasal spray, tablet and the newest
      form melt.

      Baeyens et al demonstrated an increased prevalence of attention deficit-hyperactivity
      disorder (ADHD) in children with MNE According to recent data there is a high incidence of
      periodic limb movements in sleep at night in children with nocturnal enuresis. Those children
      have an increased cortical arousability leading to awakening.

      The frequent awakening most likely has an influence on concentration and other ADHD-symptoms
      in daily life.

      This study will assess the impact of desmopressin melt on prepulse inhibition, ADHD-symptoms,
      cognition and learning, sleep, quality of life and self esteem.

      New patients aged 6-16 years with monosymptomatic nocturnal enuresis, nocturnal polyuria and
      sleep problems are tested before the start of the study medication desmopressin melt (T1) and
      6 months later (T2). It is a multi-method, multi-informant study.
    


Intervention name(s): Desmopressin lyophilisate (Melt)
Intervention type(s): Drug
Intervention description(s): Patient receives Desmopressin lyophilisate (Melt).
Intervention MeSH terms: Deamino Arginine Vasopressin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: enuresis
A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117
Condition: Healthy; HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed study is a first-in-man phase I study that aims to evaluate the safety,
      tolerability and pharmacokinetics of 3BNC117 in HIV-infected and HIV-uninfected subjects, and
      its antiretroviral activity in HIV-infected subjects.
    

Detailed description: 
      In preclinical studies carried out in humanized mice and non-human primates, 3BNC117 alone or
      in combination with other neutralizing antibodies led to protection from HIV-1 or SHIV
      infection and also to sustained suppression of HIV-1 plasma viremia. The aims of this
      protocol are to evaluate the safety, tolerability and pharmacokinetics profile of 3BNC117 in
      both HIV-infected and HIV-uninfected subjects,and its antiretroviral activity in HIV-infected
      subjects.
    

Intervention name(s): 1 mg/kg, single dose IV administration of 3BNC117; 3 mg/kg, single dose IV administration of 3BNC117; 10 mg/kg, single dose IV administration of 3BNC117; 30 mg/kg, single dose IV administration of 3BNC117; 10 mg/kg, two doses IV of 3BNC117; 30 mg/kg, two doses IV of 3BNC117
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 1 mg/kg, single dose IV administration of 3BNC117; 3 mg/kg, single dose IV administration of 3BNC117; 10 mg/kg, single dose IV administration of 3BNC117; 30 mg/kg, single dose IV administration of 3BNC117; 10 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12; 30 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Healthy Volunteers; HIV
Sequence of Radiation and Targeted Therapy in Brain Metastases
Condition: The Optimal Sequence of Radiotherapy and Systematic Tyrosine Kinase Inhibitors in Treating Brain Metastases
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Study type: Observational

Summary: 
      The investigators conducted a single institutional, retrospective cohort study to demonstrate
      the appropriate treatment strategy of upfront intracranial radiotherapy or upfront targeted
      therapy in patients with brain metastases, including an assessment of its feasibility and
      toxicity.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent hypofractionated stereotactic radiotherapy planning at our
        institution from October 2010 to October 2020
      
Keywords: Brain metastases; Radiotherapy; Targeted therapy
A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD)
      of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy
      subjects. Effect of food will also be evaluated in Part A.
    


Intervention name(s): ABI-4334 Tablet; ABI-4334 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ABI-4334 Tablet; Placebo to ABI-4334 Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ABI-4334; PK; Healthy Subjects
A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, open-label, single-center, 3-way crossover study in healthy
      subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will
      consist of 3 study periods separated by a washout period of at least 7 days. Subjects will
      receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be
      discharged from the study on Day 6 of Period 3 after completion of discharge procedures.
    


Intervention name(s): E3810; Aciphex (rabeprazole); Nexium (esomeprazole)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): RAB ER 50 mg capsule once per day on Days 1-5; Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5; Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5
Intervention MeSH terms: Esomeprazole; Rabeprazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rabeprazole; esomeprazole; h. pylori-negative; nocturnal acid breakthrough; intragastric pH, PK/PD; effect on gastric pH in healthy, H. pylori-Negative subjects
Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors
Condition: Endometrial Adenocarcinomas; Neuroendocrine Tumors; Small-cell Lung Cancer With Less Than 2 Prior Cytotoxic-containing Lines of Therapy
MeSH terms: Small Cell Lung Carcinoma; Neuroendocrine Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination
      with Fixed Doxorubicin in Non- Heavily Pretreated Patients with Selected Advanced Solid
      Tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183
      in combination with doxorubicin, to characterize the safety profile and feasibility of this
      combination, to characterize the pharmacokinetics (PK) of this combination, to obtain
      preliminary information on the clinical antitumor activity,to explore the feasibility, safety
      and efficacy of a potential improvable dose of this combination in selected tumor types [i.e.
      small cell lung cancer (SCLC) and endometrial cáncer] and to evaluate the pharmacogenomics
      (PGx) in tumor samples of patients exposed to PM01183 and doxorubicin at the RD in order to
      assess potential markers of response and/or resistance.
    

Detailed description: 
      The study has currently met its primary end point and is now recruiting patients to be
      treated at the RD expansion cohort of selected tumor types, specifically: endometrial
      adenocarcinomas, neuroendocrine tumors, and small-cell lung cancer (SCLC).
    

Intervention name(s): lurbinectedin (PM01183); Doxorubicin
Intervention type(s): Drug; Drug
Intervention description(s): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.; Commercially available presentations of vials containing doxorubicin will be provided as appropriate.
Intervention MeSH terms: Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lurbinectedin; PM01183; tumors; cancer; Pharma Mar
A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to understand how quickly lansoprazole, once daily (QD),
      improves feeding in premature babies or babies less than 28 days of age.
    

Detailed description: 
      A Phase 1, multicenter, pharmacokinetic/Pharmacodynamic and safety study in which infants
      will be randomized in an open-label fashion to receive 5 days of open-label treatment with
      lansoprazole pediatric suspension 1 mg/kg/day oral, or lansoprazole pediatric suspension 2
      mg/kg/day oral. On Dosing Days 1 and 5, blood samples will be obtained for drug assay. All
      subjects will be evaluated for inclusion in the pH monitoring portion of the study and will
      undergo pH monitoring, provided it is clinically indicated, at the discretion of the
      investigator. Intragastric pH monitoring (up to 24 hours) will be performed at Baseline, on
      Dosing Day 1 (or Day 2) and on Dosing Day 5 (or Day 6). Intraesophageal pH may be done in
      addition to intragastric pH at the discretion of the investigator. Subjects will be evaluated
      for safety, including a follow-up visit on Post-Dosing Day 14.
    

Intervention name(s): Lansoprazole; Lansoprazole
Intervention type(s): Drug; Drug
Intervention description(s): Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.; Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric GERD; Pediatric Gastroesophageal Reflux Disease; lansoprazole
Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from
      Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir
      Disoproxil Fumarate.

      In Open-Label, phase 3 studies, we randomly assigned patients with hepatitis B e antigen
      (HBeAg)-negative or HBeAg-positive chronic HBV infection to receive Tenofovir Disoproxil or
      Tenofovir Disoproxil Fumarate (ratio, 2:1) once daily for 48 weeks
    

Detailed description: 
      Tenofovir Disoproxil and Tenofovir Disoproxil Fumarate is a nucleotide analogue and a potent
      inhibitor of human immunodeficiency virus type 1 reverse transcriptase and hepatitis B virus
      (HBV) polymerase.

      The primary efficacy end point at week 48 of this study was defined as the combination of an
      HBV DNA level of less than 400 copies per milliliter and histologic improvement .
    

Intervention name(s): Tenofovir Disoproxil Fumarate; Tenofovir Disoproxil
Intervention type(s): Drug; Drug
Intervention description(s): Viread 300mg; Virehepa 245mg
Other intervention name(s): Viread; Virehepa
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label, randomized, Parallel
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy of Salmon Protein Hydrolysate Powder on Energy Increase and Anti-inflammatory Modulation in Healthy Males and Females
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the efficacy of Salmon Protein Hydrolysate Powder
      (CollaGo®) on energy increase and anti-inflammatory modulation in healthy males and females.
      Eligible participants will be asked to consume 1 sachet of CollaGo for 128 days and keep a
      study diary. Assessments will be measured at the randomization visit, and the end of study
      visit.
    


Intervention name(s): Salmon Protein Hydrolysate
Intervention type(s): Dietary Supplement
Intervention description(s): 4g of salmon protein hydrolysate per serving.
Other intervention name(s): CollaGo®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Energy increase; Energy; Healthy; anti-inflammatory; Open-label; Salmon protein; Natural health product; Dietary supplement