bioihbjkbjnl/mcl2 huggingface dataset:
Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
Condition: Thyroid Cancer
MeSH terms: Thyroid Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the prophylactic ipsilateral central lymph
      node dissection is equally effective in the management of papillary thyroid
      microcarcinoma(PTMC) to the bilateral central lymph node dissection.
    

Detailed description: 
      The extent, the advantage and disadvantage of prophylactic central lymph node dissection was
      not fully established up to now in papillary thyroid microcarcinoma.

      Prophylactic bilateral central lymph node dissection can give a important clinical
      information about the status of lymph nodes, and possibly guide a further adjuvant treatment.
      However, it causes high postoperative morbidity, including hypocalcemia and hoarseness. In
      this respect, some advocate no central lymph node dissection in prophylactic settings.

      Thus, we aimed to prove the efficacy of prophylactic ipsilateral central lymph node
      dissection in thyroid papillary microcarcinoma, compared to the bilateral dissection and no
      dissection.

      Type of Study design: Prospective randomized, controlled double-blinded (to subjects and
      observers) study.

      Group I: Limited/ipsilateral central lymph node dissection (UniCND) Group II:
      Comprehensive/bilateral central lymph node dissection (BiCND) Group III: No central lymph
      node dissection (NoCND)

      Outcomes: vocal cord palsy, hypocalcemia, locoregional recurrence, distant metastasis
    

Intervention name(s): Prophylactic central lymph node dissection
Intervention type(s): Procedure
Intervention description(s): prophylactic ipsilateral versus bilateral central lymph node dissection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Papillary thyroid carcinoma; Lymph node dissection; Lymph node metastasis; Prophylactic node dissection; Central lymph node metastasis
The Effect of Lavender Inhalation on Sleep Quality in Individuals With Coronary Heart Disease
Condition: Nursing Caries
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      The study is planned to be conducted as a two-group randomized controlled trial to determine
      the effect of lavender inhalation on individuals with coronary heart disease. Research data
      will be collected at Çukurova University Medical Faculty Balcalı Hospital Cardiology Clinic
      between January-June 2023. In the study, at least 56 samples were found to be sufficient for
      the sample size. The data of the study will be collected using the Personal Information Form
      and the Pittsburg Sleep Quality Index.
    


Intervention name(s): THE EFFECT OF LAVENDER INHALATION ON SLEEP QUALITY IN INDIVIDUALS WITH CORONARY HEART DISEASE
Intervention type(s): Other
Intervention description(s): The index includes 24 questions that evaluate the quality of sleep and the type and severity of sleep disorders experienced in the last 1 month period. The total score in the index takes a value between 0-21. If the total score is higher than 5, it is interpreted as poor sleep quality.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
Condition: Post-Operative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of
      Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be
      randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril
      intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for
      tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is <3 months,
      and the planned sample size was 170 patients.
    


Intervention name(s): granisetron; granisetron
Intervention type(s): Drug; Drug
Intervention description(s): 20 micrograms intravenously (iv) 15 min prior to end of surgery; 40 micrograms intravenously (iv) 15 min prior to end of surgery
Other intervention name(s): Kytril; Kytril
Intervention MeSH terms: Granisetron
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of One Session Osteopathic Manuel Treatment on Femoral Artery Diameter and Flow
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effect of one session OMT on arterial
      circulation in patients with PAD.
    

Detailed description: 
      15 patients with PAD were included in the study. The OMT circulation model was applied to the
      participants for one session. Before and after the application, femoral artery diameter and
      flow rate in the patients were evaluated by doppler ultrasound
    

Intervention name(s): OMT session
Intervention type(s): Other
Intervention description(s): Patients with PAD will be received 30 minutes of osteopathic manual treatment for one session. During application, the patient was in the supine position. OMT treatment session include, sub occipital release technique, supraclavicular release technique, sternal mobilization, omentum minus release, liver pumping, diaphragmatic mobilization, grand manevra technique, hip mobilization, knee mobilization and ankle mobilization. Each technique was applied for 3 minutes to patients.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral arterial disease; Osteopathic manual treatment
Patient Education in Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional

Summary: 
      Patients with gastroesophageal reflux disease (heart-burn, acid regurgitation)may benefit
      from an educational program explaining the medical aspects of the disease, self-management
      strategies and how to deal with health services. We hypothesized that patients having
      participated in an educational program would experience an improved quality of life when
      compared to patients who did not take part (controls).
    


Intervention name(s): Patient education
Intervention type(s): Behavioral
Intervention description(s): An educational program: Three lessons spaced over 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: GERD; Dyspepsia; Education; Information
Human Intervention Study of Egg Protein Derivative on Cardiovascular Risk
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Heart disease and stroke are the most common cause of death in Ireland today.One of the main
      risk factors for heart disease and stroke is high blood pressure or hypertension. Research
      has found that certain specific proteins or peptides found in foods such as dairy, meat, fish
      and eggs may promote heart health reducing blood pressure in adults with hypertension. The
      aim of this study is to investigate the potential beneficial effects egg peptides may have on
      heart health, in particular, effects on blood pressure.
    

Detailed description: 
      Poor dietary habits of Irish adults has been accompanied by epidemics of obesity and
      metabolic disorders such as type II diabetes leading to a substantial predicted increase in
      the prevalence of chronic diseases such as cardiovascular disease.Hypertension is a major
      contributing factor to the development of cardiovascular and metabolic diseases. Dietary
      factors play a significant role in the prevention and/or treatment of hypertension and
      therefore the development of foods with antihypertensive properties could prove beneficial.
    

Intervention name(s): Egg albumin-derived peptide
Intervention type(s): Dietary Supplement
Intervention description(s): Double-blind intervention study cross-over design with one sachet containing 3g Egg albumin-derived peptide (Tensio-control) or placebo (maltodextrin) in Phase one followed by cross-over in Phase 2.
Other intervention name(s): Tensio-control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Blood Pressure; Hypertension; Cardiovascular disease
A Bioequivalence Study of L04TD3 Compared to Administration of L04RD1 in Healthy Volunteers
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to
      evaluate bioequivalence after administration of L04RD1 or administration of L04TD3 in healthy
      volunteers.
    


Intervention name(s): L04RD1; L04TD3
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet of L04RD1; 1 tablet of L04TD3
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adding Deep Front Line Myofascial Release to Selected Exercises in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      the aim of the study is to investigate the effect of deep front line myofascial release to
      selected exercises in patients with knee osteoarthritis
    

Detailed description: 
      : Knee osteoarthritis (KOA) also known as degenerative joint disease, is typically the result
      of wear and tear and progressive loss of articular cartilage.

      The myofascial meridian is a new approach to the facial restriction .the knee capsules, the
      adductor muscles and the tipialis posterior are part of the deep front line which is a line
      of the myofascial meridian.

      Exercise is the highest evidence in the treatment of knee osteoarthritis. The myofascial
      release is effective in the treatment of knee osteoarthritis so the study will investigate
      the effect of adding deep front line myofascial release to selected exercises in patients
      with knee osteoarthritis.
    

Intervention name(s): exercises; myofascial release
Intervention type(s): Other; Other
Intervention description(s): strengthening of the gluteus maximus and medius, calf muscles stretching for calf and hamstring muscles; myofascial release using instrument assisted soft tissue mobilization
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: exercise plus myofascial release of the adductor and tipialis posterior muscles.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: myofascial release; Knee osteoarthritis; Deep front line
Effect of Grape Seed Extract on Blood Pressure
Condition: Elevated Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether an 8-week intervention with grape seed
      extract is effective in reducing daytime ambulatory blood pressure in male and postmenopausal
      female with elevated daytime blood pressure values.
    

Detailed description: 
      Background: High blood pressure is a major risk factor for morbidity and mortality from
      stroke, heart disease, and end-stage renal disease. Several studies have shown that dietary
      polyphenols derived from fruits and vegetables (including those from grape products) can
      lower blood pressure in both normotensive and hypertensive subjects.

      Study objectives: Primary objective: To study, in subjects with elevated blood pressure
      levels, the effects of grape seed extract high in polyphenols, on daytime ambulatory systolic
      and diastolic blood pressure (SBP and DBP, respectively). Secondary objective: To explore
      mechanistic pathways responsible for the blood pressure lowering efficacy in case a blood
      pressure lowering effect is shown.

      Study population: Each treatment group will consist of 35 men and postmenopausal women (35-75
      years of age) with daytime SBP between 120 and 159 mmHg. The total number of subjects will be
      70.

      Study design: This study will have a randomized, double-blind, placebo-controlled parallel
      design with 2 treatments, a 1-week run-in period, and an 8-week intervention period. The 2
      treatments will consist of placebo capsules and capsules with grape seed extract.

      Study outcomes: Daytime ambulatory blood pressure (ABP) will be measured every 20 minutes for
      2 x 12 hours at baseline and 2 x 12 hours at the end of intervention. Furthermore, before and
      after the intervention period, 24-hour urine will be collected and 2 blood samples will be
      taken in order to investigate mechanistic pathways and platelet function.
    

Intervention name(s): Grape seed extract; Microcrystalline cellulose (placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will daily consume one capsule with grape seed extract for 8 weeks.; Subjects will daily consume one capsule with microcrystalline cellulose for 8 weeks.
Other intervention name(s): Polyphenol
Intervention MeSH terms: Grape Seed Extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Blood pressure; Grape seed
Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas
Condition: Pancreatic Cancer Metastatic
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      A prospective, multicenter, open label, randomized phase III study to evaluate efficacy and
      safety of FFX versus CPI-613 + mFFX in patients with metastatic adenocarcinoma of the
      pancreas with age range of 18 to 75 years
    


Intervention name(s): CPI 613, mFolfirinox; Folfirinox
Intervention type(s): Drug; Drug
Intervention description(s): CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port. mFolfirinox: given immediately after CPI-613 administration; Folfirinox
Other intervention name(s): CPI-613,Oxaliplatin, folinic acid, irinotecan, flurouracil; Oxaliplatin, folinic acid, irinotecan, flurouracil
Intervention MeSH terms: Leucovorin; Folic Acid; Oxaliplatin; Irinotecan; Folfirinox; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Of INIT Versus NMR in Patients With Deep Gluteal Syndrome
Condition: Deep Gluteal Syndrome
MeSH terms: Sciatica; Piriformis Muscle Syndrome; Syndrome
Study type: Interventional

Summary: 
      Rationale of this research is to evaluate the outcome of Comparison of Integrated
      Neuromuscular Inhibition technique versus Neuromuscular reeducation on pain in patients with
      Deep Gluteal Syndrome. The significance of this study is to identify which technique is
      superior in alleviating the symptoms of deep gluteal syndrome. This study will help gather
      evidence on the practice of incorporating trigger point therapy in the treatment of deep
      gluteal syndrome.
    

Detailed description: 
      Deep gluteal syndrome is a common buttock and posterior hip pain caused by entrapment of the
      sciatic nerve in the posterior hip region. Nonoperative therapy involves treating the
      entrapment location, using rest, anti-inflammatories, musclerelaxants, and physical therapy
      to relieve compression. The purpose of the study was to evaluate the effects of Integrated
      Neuromuscular Inhibition Technique versus Neuromuscular Reeducation Technique on pain in
      subject with deep gluteal syndrome. It was a randomized, controlled trial, conducted among
      deep gluteal syndrome patients. Sample size was 54 by using G Power Tool software.
      Participantswere randomly assigned to the intervention or control group after a baseline
      assessment with a lottery ticket and an opaque envelope. All participants in both groups were
      evaluated on baseline and 12 th Session.
    

Intervention name(s): Integrated Neuromuscular Inhibition Technique; Neuromuscular Reeducation Technique
Intervention type(s): Other; Other
Intervention description(s): After palpating the trigger point ischemic compression were applied for 20-60 sec while strain Counterstain for 60-90 sec and MET is for 7-10 sec.; Deep pressure were applied along origin and insertion of Piriformis and hamstring muscle combined with active movement of patient for 5 -15 time as per required
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Trigger point; NMR; INIT; Deep Gluteal Syndrome
A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children
Condition: Dengue Fever; Dengue Hemorrhagic Fever; Dengue Shock Syndrome
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Shock
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of two different
      formulations of an investigational dengue vaccine (T-DEN) against a placebo vaccine when two
      doses are given six months apart to adults and children.
    

Detailed description: 
      In this study, children and adults at multiple sites in Puerto Rico will be randomly
      allocated to receive one of two T-DEN formulations or placebo. Subjects will be stratified by
      age group (a specific number of subjects in each of 4 age groups [12 months to 50 years of
      age] will be enrolled). The study includes 6 scheduled visits and 4 scheduled venipunctures.
      Safety follow-up for dengue may require unscheduled visits and venipunctures.> Multiple DEN
      virus serotypes are endemic in Puerto Rico and all residents are considered to be at risk for
      dengue. The results of this phase II study will provide a basis for identifying the vaccine
      formulations which elicit neutralizing antibodies to all four dengue virus serotypes in a
      high proportion of vaccine recipients. The most immunogenic and well tolerated candidate
      formulation identified in this study will be considered for advancement to phase III
      development.>
    

Intervention name(s): Placebo; T-DEN-Post-Transfection F17; T-DEN-Post-Transfection F19
Intervention type(s): Other; Biological; Biological
Intervention description(s): Lyophilized, single dose vials and sterile water for
> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months; Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months; Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Dengue; Virus; Live-attenuated; Vaccine; Dengue viral infection; Dengue Vaccine
Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients
Condition: Diabetes Mellitus, Type 2; Implant Complication
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The aim of the present study was to compare the initial healing and long term performance of
      narrow diameter implants in patients with uncontrolled Diabetes mellitus type 2 (T2DM) and
      healthy individuals.
    


Intervention name(s): Implantation
Intervention type(s): Procedure
Intervention description(s): Patients received narrow diameter implants in posterior mandible or maxilla
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All
Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
Condition: Invasive Aspergillosis
MeSH terms: Aspergillosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, efficacy, and pharmacokinetics of posaconazole (POS)
      intravenous (IV) and oral formulations in pediatric participants 2 to <18 years of age with
      invasive aspergillosis (IA).
    


Intervention name(s): Posaconazole IV; Posaconazole PFS; Posaconazole tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Posaconazole (POS) 6 mg/kg body weight by IV infusion; POS PFS 6 mg/kg body weight taken orally; POS tablet 300 mg taken orally
Other intervention name(s): MK-5592; SCH 056592; Noxafil®; MK-5592; SCH 056592; Noxafil®; MK-5592; SCH 056592; Noxafil®
Intervention MeSH terms: Posaconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Hearing Aid Benefit
Condition: Hearing Loss, Sensorineural
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      The present study will investigate the benefit of hearing aids for speech intelligibility (in
      both quiet and noisy environments) compared to the unaided condition. Participants will
      include adults with moderate to moderately severe hearing impairment. The participants will
      complete laboratory-based speech intelligibility assessments with binaural hearing aids and
      without hearing aids.
    


Intervention name(s): New hearing aid
Intervention type(s): Device
Intervention description(s): Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Three Doses of BI 187004 Over 28 Days in Patients With Type 2 Diabetes Mellitus With and Without Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Assess the safety and tolerability of once daily oral doses of BI 187004 in patients with
      type 2 diabetes mellitus without oral antidiabetic treatment and in patients on a stable
      metformin background treatment over 28 days. Assess the effect on fasting plasma glucose
      after 28 days of treatment and to investigate the pharmacokinetics and pharmacodynamics of BI
      187004.
    


Intervention name(s): Placebo; Placebo; Placebo; BI 187004; Placebo; BI 187004; BI 187004; BI 187004
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): BI 187004 high dose matching placebo once daily; BI 187004 medium dose matching placebo once daily; BI 187004 high dose matching placebo once daily add on to background metformin; BI 187004 high dose once daily add on to background metformin; BI 187004 low dose matching placebo once daily; BI 187004 medium dose once daily; BI 187004 low dose once daily; BI 187004 high dose once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment