bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Post-discharge educatıon provıded vıa Tele-nursıng to Elderly patıents
Condition: Tele-Nursing
MeSH terms: Hip Fractures
Study type: Interventional

Summary: 
      Purpose: The aim of this study is to evaluate the effect of post-discharge training given via
      tele-nursing to elderly patients operated for hip fracture on the quality of life and
      functional independence levels of the patients.
    

Detailed description: 
      Materials and Methods: This randomized controlled, pretest-posttest, single-center
      experimental study was conducted in a hospital between August 2022 and April 2023, with 30
      patients in the intervention group and 30 patients in the control group. Nursing intervention
      was administered to the intervention group by three educational online video calls (1st, 2nd
      and 3rd weeks after discharge), three educational voice phone calls (4th, 5th and 6th weeks
      after discharge) and It consists of a training booklet with educational content. No
      intervention was applied to the control group. Research data; It was collected using the
      Patient Introduction Form, SF-36, FIM. Informed consent was obtained from the patients and
      caregivers with the permission of the ethics committee and the institution. Data analysis was
      done using Chi-Square, Independent T-Test and Dependent T-Test.
    

Intervention name(s): Education provided via TeleNursing
Intervention type(s): Behavioral
Intervention description(s): Online Video Call Online video interviews were conducted with the patients in the intervention group once in the first week (day 1-7), once in the second week (day 8-14) and once in the third week, using mobile phone programs and/or computer programs that provide video conversation opportunities. It was conducted in the form of remote online video calls, held three times in total, once within the 15-21st day.
Voice Phone Call After audio telephone interviews and online video interviews were completed within the first three weeks after the patients in the intervention group were discharged; It was carried out using a mobile phone 3 times in total: once in the fourth week (day 22-28), once in the fifth week (day 29-35) and once in the sixth week (day 36-42).
Other intervention name(s): Online Video Call and Voice Phone Call
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Functional Independence; Hip Fracture,; Post-Discharge Education,; Telenursing,; Quality of Life.
Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, (CAIV-T) in Healthy Children
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      - Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels
      of a Liquid Formulation of(CAIV-T) in Healthy Children.
    

Detailed description: 
      - A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III, Multicenter Trial
      to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a
      Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted
      (CAIV-T) in Healthy Children
    

Intervention name(s): CAIV-T, Liquid
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Adenoma Detection Rate With Position Change at Colonoscopy
Condition: Polyps
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      The hypothesis to be tested is that position changes during the withdrawal phase of
      colonoscopy leads to a higher adenoma (polyp) detection rate because of better distension of
      the colon. Since adenomas are precancerous lesions the enhanced adenoma detection will
      increase the success of colorectal cancer screening programmes. This study will provide
      evidence for the value of position changes and encourage endoscopist to adopt position change
      as a routine in their practice.

      May 2007: protocol amendment to include additional prospective analysis using High Definition
      TV (HDTV).
    

Detailed description: 
      Colorectal cancer is the second commonest cause of cancer death. In a majority of cases it is
      preceded by a precancerous lesion called an adenoma (commonly known as polyp). Detection and
      removal of adenomas at colonoscopy has been shown to reduce mortality from colorectal cancer.
      The success of the impending colorectal cancer screening programme to reduce cancer mortality
      in an average-risk population depends on optimal adenoma detection at colonoscopy. The
      detection of adenomas has been shown to vary between different endoscopist. Some of the
      factors that have been reported to affect adenoma detection rates included the time spent
      viewing, the adequacy of the bowel preparation and the time spent cleaning the colonic mucosa
      of excess fluid. Careful examination of proximal side of flexures, folds and valves by the
      endoscopist is equally important. However, even with careful examination adenoma detection
      rates have been shown to vary between endoscopist from 8.6% to 15.9%. Previous experience and
      training may be contributed to this difference. Some endoscopist adopt regular changes in
      position during the procedure to maximize distension of the colon. Better luminal distension
      enhances mucosal views for detection of the smaller adenomas. The validity of this approach
      has never been tested and we propose that this factor may contribute to the differences in
      adenoma detection rates.

      Patients will be randomised to either position 1 first then position 2 or vice versa and
      examined twice. During one withdrawal the colon will be examined with the participant in the
      left lateral position only (position 1) or with position changes (position 2)or vice versa.

      May 2007: protocol amendment to include additional prospective analysis using High Definition
      TV (HDTV). No further patient data collection involved.
    

Intervention name(s): Colonoscopy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Diagnostic
Keywords: position change; adenoma; colonoscopy
Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery
Condition: ARDS, Human
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of intermittent, nearly vertical,
      patient positioning in a specialized upright bed, on outcomes of mechanically ventilated
      patients with acute respiratory distress syndrome (ARDS) who are in the ICU.
    

Detailed description: 
      The purpose of this study is to determine the effect of intermittent, nearly vertical,
      patient positioning in a specialized upright bed, on outcomes of mechanically ventilated
      patients with acute respiratory distress syndrome (ARDS) who are in the ICU. This study is a
      prospective, non-blinded, feasibility, randomized study of ARDS patients, who will be
      randomized into two treatment groups. One treatment arm will deliver scheduled sessions of
      upright bed positioning (study intervention), while the other treatment arm receives routine
      bed position care (care provided exclusively with the bed in the supine position). ICU
      Practitioners know that positional changes improve clinical outcomes when turning patients
      from supine to prone (back to belly); however, other positional changes including upright
      positioning are far less studied. It is well known that in ARDS patients who become proned,
      an improvement in aeration occurs in the dorsal lung regions (prone positioning has been
      shown to reduce ARDS mortality). Thus the investigators predict that in this study, the
      upright positioning holds the potential to further recruit collapsed lung areas. Augmentation
      of aerated lung while in the upright position is expected to increase the highest value
      measured per ventilator day of the respiratory system compliance in the upright bed position
      arm, in a greater fashion than the highest value measured per ventilator day of daily total
      respiratory system compliance for the usual care arm.
    

Intervention name(s): upright bed
Intervention type(s): Procedure
Intervention description(s): moving the bed into an upright position
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention arm will undergo a protocol of 4x per day bed elevation to 60 degrees for 30 minutes.
Masking: None (Open Label)
Primary purpose: Treatment
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0980 Following Single Oral Dose Administration in Healthy Postmenopausal Female Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, non-randomized, absorption, metabolism, and excretion study
      of [14C]-GDC-0980 administered as a 10-mg oral dose to 6 healthy postmenopausal and/or
      surgically sterile female subjects following at least a 10-hour fast from food (not including
      water).
    


Intervention name(s): [14C]-GDC-0980
Intervention type(s): Drug
Intervention description(s): 100 uCi of [14C]-GDC-0980 in total dose of 10 mg GDC-0980
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating Pneumococcal Vaccine in Healthy Infants
Condition: Healthy Subjects; Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent
      pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this
      vaccine in infants.
    


Intervention name(s): 13-Valent Pneumococcal Conjugate Vaccine (13vPnC); 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Infant Vaccine
Study to Evaluate the Tolerance and Safety of a Peptide-based Enteral Formula With Partially Hydrolyzed Guar Gum (PHGG)
Condition: Enteral Nutrition
Study type: Interventional

Summary: 
      This is a Multicenter, Open-label, Single-arm study evaluating the Tolerance and Safety of a
      Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG) in the Nutritional
      Management of Tube-fed Children Aged 1-4 Years over a 7 day period.
    


Intervention name(s): Enteral Formula With (PHGG)
Intervention type(s): Other
Intervention description(s): Pediatric subjects will be fed a Peptide-based Enteral Formula With Partially Hydrolyzed Guar Gum (PHGG)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Use of Platelet Rich Plasma (PRP) for Improving Thin Endometrium
Condition: Poor Endometrium
Study type: Interventional

Summary: 
      Platelets rich plasma is simple source of growth factors and cytokines that can regulate
      endometrial growth for subgroup of thin endometrium women. It is an autologous source of this
      enhancing factors; therefore, there os no risk of using it within the same participant.
    


Intervention name(s): Treatment of Thin Endometrium
Intervention type(s): Other
Intervention description(s): This is a trial to improve endometrial thickness by autologous injection of PRP into the Uterine Cavity compared with CSF or no treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults
Condition: Common Cold; Influenza, Human; Acute Respiratory Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Respiratory Tract Infections; Virus Diseases; Common Cold
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Ingavirin® 90 mg once daily is effective
      and safe for the treatment of influenza and other laboratory confirmed acute respiratory
      viral infections in the course of standard therapy in patients 18-60 years old.
    

Detailed description: 
      Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the
      Efficacy and Safety of Ingavirin in the Treatment of Influenza and Other Acute Viral
      Respiratory Infection. Study treatment was 5 days followed by 2 ± 1 days of follow up period.
      Thus, study participation was 7 ± 1 days (8 days max).
    

Intervention name(s): Ingavirin; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Imidazolyl ethanamide pentandioic acid
Intervention MeSH terms: Pentanedioic acid imidazolyl ethanamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Respiratory Tract Infections; Acute Respiratory Viral Infection
Efficacy and Safety of Pioglitazone in Treating Subjects With Vascular Complications Associated With Type 2 Diabetes Mellitus.
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the efficacy of pioglitazone compared to
      glibenclamide, once daily (QD), taken together with metformin and lifestyle modification in
      type 2 diabetic subjects with cardiovascular disease.
    

Detailed description: 
      Diabetes is one of the most common chronic diseases worldwide, affecting nearly 200 million
      people, almost all suffering from Type 2 Diabetes. It is the fourth leading cause of death in
      developed countries due to the negative impact of the disease on the cardiovascular system.
      Treatment, aimed to the reduction of this intrinsic cardiovascular risk, is based on tight
      control of glucose and all coexisting metabolic abnormalities as well as of biomarkers of
      inflammation and atherogenesis.

      Macrovascular complications account for the vast majority of morbidity and mortality in
      diabetic patients, and there is growing evidence that pathophysiologic mechanisms other than
      hyperglycemia are responsible. The condition of the vascular endothelium in particular has
      been shown to effect the health and disease of the cardiovascular system.

      The number and function of endothelial progenitor cells correlate inversely with
      cardiovascular risk factors and may be a surrogate biologic marker for vascular function and
      cumulative cardiovascular risk.

      Pioglitazone is an orally active thiazolidinedione derivative. It is a ligand for peroxisome
      proliferator-activated receptor-gamma activation that alters transcription of various genes
      regulating carbohydrate and lipid metabolism.
    

Intervention name(s): Pioglitazone and Metformin; Glibenclamide and Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Pioglitazone 30 mg, tablets, orally, once daily, metformin stable dose and lifestyle modification for up to 24 weeks.; Glibenclamide 10 mg, tablets, orally, once daily and metformin stable dose and lifestyle modification for up to 24 weeks.
Other intervention name(s): ACTOS®; AD-4833; Diabeta; Glynase; Micronase; Daonil; Semi-Daonil; Euglucon
Intervention MeSH terms: Metformin; Pioglitazone; Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy
Clinical Safety of a Novel Milk Protein Peptide
Condition: Drug Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      Background: A novel milk peptide has been shown in laboratory setting to have natural
      anti-cancer properties and extend lifespan and improve metabolism in animal models. The
      purpose of this study was 1.) to determine the safety dosage range and, 2.) to determine
      whether this novel milk peptide positively influence blood markers, metabolism and improve
      quality of life.
    

Detailed description: 
      The study was conducted as a randomized, double-blind, placebo-controlled clinical trial in a
      university research setting. Healthy volunteers were randomly assigned to ingest in a
      double-blind and randomized manner either a placebo or milk peptides. Outcome measures were
      assessed at 0, 3, and 6 weeks of supplementation.
    

Intervention name(s): Hydrolyzed milk protein mixture; Glycerol placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Take twice a day, dosage 6 ml-21 ml based on weight, mix with 1/2 cup of milk.; Participants ingested 6ml-21ml of placebo mixed with 1/2 cup milk twice daily. The supplements were prepared in liquid form and packaged in generic bottles for double blind administration. The placebo was a starch-based placebo matched for color, texture, and taste to the active supplement.
A food diary is maintained daily.
Other intervention name(s): AX-4
Intervention MeSH terms: Caseins; Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH)
Condition: Schizophrenia; Schizoaffective Disorder; Delusional Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Schizophrenia, Paranoid
Study type: Interventional
Phase: Phase 4

Summary: 
      Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders,
      and several antidepressive agents have been successfully applied. The new melatonergic
      antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia
      for several reasons. The investigators plan to test the efficacy and tolerability of AGO for
      antidepressive treatment in schizophrenia. For this task, the investigators plan to enrol 27
      schizophrenic patients into an open, single-armed, prospective clinical trial with
      agomelatine.
    

Detailed description: 
      Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders,
      and several antidepressive agents have been successfully applied. The new melatonergic
      antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia
      for several reasons: 1. AGO provides a unique pharmacological profile by combining
      antidepressive potency, sleep regulation and enhancement of frontocortical dopaminergic
      activity by 5-HT-2C-blockade. 2. AGO might exert favourable effects on cognition. 3. While
      pharmacokinetic interactions are generally possible, major influences on antipsychotic
      substances are unlikely due to metabolism by cytochrome isoenzymes CYP1A2 and CYP2C9/19. 4.
      AGO is characterized by a favourable range of adverse events (AE) which do not overlap with
      typical antipsychotic AEs such as weight gain and sexual dysfunction. Thus, the risk of
      additive effects seems to be small. The investigators plan to enroll 27 schizophrenic
      patients into an open, single-armed, prospective clinical trial with agomelatine. As
      predefined primary and secondary endpoints, we are going to investigate whether AGO is able
      to improve MDE severity, sleep quality, general and psychosocial functioning as well as
      cognitive function in schizophrenia without detrimental effects on the psychotic syndrome.
      Moreover, we intend to monitor for pharmacokinetic interactions. The results obtained will
      allow designing future randomized and controlled clinical trials in order to improve the
      range of therapeutic options for affective and cognitive deficits in schizophrenia.
    

Intervention name(s): agomelatine
Intervention type(s): Drug
Intervention description(s): Augmentation of antipsychotic therapy with 25 to 50 mg agomelatine as a single oral dosage per day
Other intervention name(s): Valdoxan
Intervention MeSH terms: Agomelatine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Depression; Cognition; Agomelatine; Antidepressant
A Food Effect Phase I Study of the Volitinib in Healthy Subjects
Condition: Food Effect; Health Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate to determine the effect of food on the PK of a
      single dose of 600 mg Volitinib and its two major metabolites in healthy subjects.
    

Detailed description: 
      The purpose of this study is to evaluate to determine the effect of food on the PK(
      pharmacokinetics) of a single dose of 600 mg Volitinib and its two major metabolites in
      healthy subjects and to assess the safety and tolerability of single doses of 600mg in
      healthy subjects.This study will be an open-label, randomized, four-period, crossover PK food
      effect study of Volitinib administered orally at 600 mg. Subjects will be screened for
      eligibility up to 14 days prior to entry into the study,there will be 4 treatments,2 weeks
      follow-up.
    

Intervention name(s): Volitinib
Intervention type(s): Drug
Intervention description(s): 600mg Volitinib ,single dose,oral
Other intervention name(s): HMPL-504
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Food Effect; Health subjects
Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy
Condition: Myomectomy
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effects of oxytocin infusion during abdominal myomectomy.
    

Detailed description: 
      Myomectomy is indicated for symptomatic uterine fibroids. Fibroids have blood supply and 20%
      of the abdominal myomectomy cases might require blood transfusion because of the nature of
      the surgery. Oxytocin infusion is one of the intervention to decrease blood loss during
      myomectomy. To evaluate the effects and benefits of oxytocin infusion during abdominal
      myomectomy we decide to conduct this randomized study.
    

Intervention name(s): Oxytocin; saline
Intervention type(s): Drug; Other
Intervention description(s): Patients will receive intravenous oxytocin infusion just before the surgery after the induction of general anesthesia.; Patients will receive intravenous normal saline infusion just before the surgery after the induction of general anesthesia.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The abdominal myomectomy cases will be randomized into 2 separate groups in a parallel fashion using an online software at 1:1 ratio.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: myomectomy; oxytocin; blood loss