bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Distal Needling on Knee Pain Using Acupuncture Techniques
Condition: Patellar Tendonitis; Complete Tear, Knee, Anterior Cruciate Ligament
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The purpose of this study is to test if specific therapeutic benefits of acupuncture are
      mostly attributable to contextual and psychosocial factors, such as patients' beliefs and
      expectations.The investigators propose using the 2 acupuncture methods, which refrains from
      inserting needles in the affected area, in order to evaluate the short-term and long-term
      efficacy of acupuncture in a clinical setting compared with placebo and compared with
      invasive needling that does not adhere to "correct" acupuncture rules.
    

Detailed description: 
      The main novel features of this study:

        1. First aim to assess the effect of distal needling on knee pain

        2. Second aim to directly compare two acupuncture techniques, placebo, needling at "wrong"
           places and "correct" needling for knee pain

      Advantages of the study compared to published data:

        1. Distal needling - enables assessment of range of motion (ROM) and pain level during
           needling.

        2. Both acupuncture systems rely on minimal questioning, which simplifies the
           patient-practitioner interactions.

        3. Exploratory studies in the clinic of DP show that it is possible to distinguish between
           "correct" and "incorrect" needling, at least in the short term. Long term effects have
           not been assessed yet.
    

Intervention name(s): Pain relief by Acupuncture needle at non-specific site; Acupuncture needle; Acupuncture needle; Acupuncture needle
Intervention type(s): Device; Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Knee pain; Acupuncture; Sham acupuncture
Vascular Changes Of Patients Undergoing Laparoscopic Radical Prostatectomy
Condition: Prostatic Neoplasms; Erectile Dysfunction Following Radical Prostatectomy
MeSH terms: Prostatic Neoplasms; Erectile Dysfunction
Study type: Observational

Summary: 
      A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using
      Doppler ultrasound and the impact of such changes on erectile function and quality of life of
      patients. The baseline study will be compared with the study one year after surgery.
    


Intervention name(s): Doppler ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Basal Doppler ultrasound and Doppler ultrasound one year after radical prostatectomy
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male patients with prostate cancer who underwent laparoscopic radical prostatectomy
Bifido- and Lactobacilli in Symptomatic Adult COVID-19 Outpatients
Condition: COVID-19 Respiratory Infection
MeSH terms: COVID-19; Respiratory Tract Infections
Study type: Interventional

Summary: 
      There is evidence that some types of probiotics play a role in alleviation of symptoms of
      acute respiratory tract infections and bursting immune response to respiratory and enteric
      viruses. Available data serves a rationale for the study exploring a role of nutritional
      support with probiotics in adult outpatients with COVID-19. Hypothesis of the study is that a
      proposed mixture of lactobacilli and bifidobacteria facilitate faster recovery from COVID-19
      and enhance specific immune response to SARS-CoV-2 antigens.
    

Detailed description: 
      One hundred adults with confirmed (PCR or antigen test) symptomatic COVID-19 lasting upto 5
      days will be screened for the study. When the subject meets enrollment criteria, he/she will
      be randomized to take an investigational product (probiotic, test dietary supplement, TDS), a
      mixture of lactobacilli and bifidobacteria or placebo 1 time a day before breakfast for 28
      days after enrollment. During observation, the patient will keep Respiratory Illness Diary.
      Blood serum will be collected at baseline, day 0-5 (Nurse Visit 1), after 28-35 days (Nurse
      visit 2), and 6 months (Nurse visit 3) for evaluation of anti-SARS-CoV-2 antibodies to
      nucleocapsid and spike antigents. In 3 months, investigator/family physician will collect
      Post-COVID-19 Questionnaire
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic will be taken 1 time a day before breakfast for 28 days.; Placebo will be taken 1 time a day before breakfast for 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intensity Modulated Radiotherapy in Recurrent T1-2 Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Cancer Recurrent
MeSH terms: Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Recurrence
Study type: Interventional

Summary: 
      The hypothesis of the study is to address the efficacy and toxicity profile of aforementioned
      four modalities for rT1-2 NPC.

      Characters of the patients:

        -  list item one: 168 patients, median age 48 years (range 16-75 years） proven rT1-2 NPC
           were diagnosed

        -  list item two: Treated with four different irradiation modalities(3D-CRT,IMRT, BT , BT
           Combined 3D-CRT or IMRT).

        -  list item three: Median time to recurrence was 30 months (range 1-180months). The median
           follow-up time was 28 months (range, 4-135 months).
    

Detailed description: 
      Objectives:

      Recurrent T1-2 Nasopharyngeal Carcinoma (rT1-2) may be salvaged by 3D - CRT（3D-Conformal
      Radiotherapy）, IMRT（ Intensity Modulated Radiotherapy）, Brachytherapy (BT), BT combined 3D -
      CRT or IMRT . The aim of this study is to address the efficacy and toxicity profile of
      aforementioned four modalities for rT1-2 NPC.

      Methods and Materials:

      168 patients, median age 48 years (range 16-75 years） proven rT1-2 NPC were diagnosed and
      treated with four different irradiation modalities(3D-CRT,IMRT, BT , BT Combined 3D-CRT or
      IMRT) . Median time to recurrence was 30 months (range 1-180months). The median follow-up
      time was 28 months (range, 4-135 months).
    

Intervention name(s): 3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT
Intervention type(s): Radiation
Intervention description(s): 3D - CRT（3D-Conformal Radiotherapy）: CTV-P 50-60Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week) IMRT（Intensity Modulated Radiotherapy）: GTV-P 50-60 Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week) BT(Brachytherapy): 2.5Gy BID*10F one week interval BT combined 3D - CRT or IMRT: First,GTV-P 40Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week);Then, 2.5Gy BID*2F
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: superiority, re-irradiation, IMRT, recurrent T1-2 NPC
Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this study is to provide clinical data pertaining to the safety and
      performance of the Globe® Mapping and Ablation System for treating patients with atrial
      fibrillation.
    

Detailed description: 
      Upon successful enrolment, subjects will be scheduled for mapping and radiofrequency (RF)
      ablation. Cardiac CT imaging, echocardiography and baseline 12-lead ECG will be performed
      pre-procedure for screening and health assessment. During the procedure the Globe catheter
      will be delivered via standard femoral vein access and transseptal puncture. Anatomical and
      electrophysiological mapping of the left atrium (LA) will be followed by RF ablation to
      achieve pulmonary vein isolation (PVI). Additional lesions will be created as deemed
      appropriate by the investigator. Intracardiac electrogram mapping will be used to confirm PVI
      during the procedure. Echocardiography will be performed at discharge to assess cardiac
      function. Electrocardiograms by 12-lead ECG and 7-day Holter monitoring will be recorded at
      discharge, and 3, 6 and 12 months after treatment. Follow-up assessments will be performed at
      discharge, 7 days, and 1, 3, 6 and 12 months after treatment, to track freedom from
      documented AF and adverse events. Subject-reported AF symptomology and quality of life will
      also be assessed during follow-up.
    

Intervention name(s): Global mapping and ablation device
Intervention type(s): Device
Intervention description(s): During the procedure the Globe catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the LA will be followed by pulmonary vein isolation (PVI) by RF ablation. Additional lesions will be created as deemed appropriate by the investigator.
Other intervention name(s): Globe® Mapping and Ablation System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation; global; radiofrequency RF ablation; left atrium anatomical and electrophysiological mapping
N-acetyl-cysteine (NAC) and Kidney Graft Function
Condition: Brain Death; Chronic Renal Insufficiency
MeSH terms: Brain Death; Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this study is to evaluate the effect of N-acetyl-cysteine (NAC) administration in
      organ donors on the kidney graft function of recipients.
    

Detailed description: 
      Ischemia-reperfusion is a major contributing factor for delayed renal function after
      transplantation. It has been shown that the administration of an antioxidant, i.e. NAC, in
      patients with chronic renal insufficiency may prevent radio contrast-induced nephropathy. Due
      to its antioxidant effects, organ donor pretreatment with NAC has demonstrated to improve
      renal graft function in two experimental studies. Study objectives: to compare the incidence
      of delayed graft renal function between two groups of patients, i.e., those receiving the
      graft from organ donors pretreated with NAC and a group control. The primary endpoint was the
      number of delayed graft function defined as the requirement of at least one sequence of
      dialysis during the first seven days following transplantation. Secondary endpoints:
      evolution of creatininemia, azotemia at day 1, 7, 14 and ,30 after surgery; acute and delayed
      transplant rejection; intrahospital mortality.

      Patients inclusion: all organ donors and recipients were eligible Exclusion criteria: for
      organ donors were preexistent chronic renal insufficiency and contra-indications for kidney
      procurement; for recipient were transplantation outside our hospital The donors were
      randomized in a single-blind fashion into two groups : the control group and the group
      receiving 600 mg IV of NAC 1 hour before and 600 mg IV 2 hours after cerebral arteriography
      required to diagnose brain death. Sample size has been calculated delayed graft function by
      50% leading to include 118 recipients in each group.

      Follow up: one year after transplantation. Study beginning in september 2006. Length of
      inclusion during 36 months.
    

Intervention name(s): N-acetylcysteine
Intervention type(s): Drug
Intervention description(s): 600 mg intravenous before and 2 hours after cerebral arteriography
Other intervention name(s): n-acetylcysteine administration
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: kidney graft,; delayed graft function; N-acetylcysteine
Effect of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women
Condition: Non Specific Knee Osteoarthritis Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      the aim of this study is to investigate the efficacy of Combination Therapy on Knee
      Osteoarthritis Pain in Postmenopausal Women
    

Detailed description: 
      Osteoarthritis (OA) is the most common musculoskeletal condition affecting the quality of
      life of older adults. The prevalence of OA is very high 45% in females in comparison to
      males, especially after menopause due to the hormonal changes. In the physical therapy
      practice, therapeutic ultrasound (US) is one of the most frequently applied
      electrotherapeutic modalities in orthopedics physiotherapy. Simultaneous application of two
      therapeutic modalities at the same site is described as combination therapy (CT). The most
      commonly used CT is US & Transcutaneous neuromuscular electrical stimulation (TENS )where
      this approach was effective in pain modulation .The use of combination therapy is highly
      preferable because of the advantageous effect both electro-therapy and ultrasound provide
      simultaneously. There are no current studies on using combination therapy in the treatment of
      pain in mild to moderate knee osteoarthritis in post-menopausal women and we don't know the
      proper treatment dose.The study is designed as a prospective, randomized, pre-posttest,
      controlled trial.where we have two groups Intervention group and control. the intervention
      group will recieve strengthening exercises in addition to combination therapy 10 minutes for
      each session, 3 times per week, for 3 weeks.The Control group will recieve the same
      strengthening exercises as intervention group and sham combination therapy 10 minutes for
      each session, 3 times per week, for 2 weeks.
    

Intervention name(s): Combination therapy (CT)
Intervention type(s): Device
Intervention description(s): Two therapeutic modalities at the same site is described as combination therapy (CT). The most commonly used CT is US & TENS where this approach was effective in pain modulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is a single-center, open-label study of the plasma pharmacokinetics of amiloride
      nasal spray at three different doses in healthy volunteers.
    

Detailed description: 
      In this clinical study, we will evaluate the plasma pharmacokinetics of amiloride nasal spray
      in healthy volunteers at three different doses. The data obtained from this study will
      provide us with pharmacokinetic information that will help develop dosing regimens for future
      clinical efficacy studies in anxiety patients. Currently, there is no information on the
      bioavailability and pharmacokinetics of amiloride in humans after intranasal administration.
      All participants will be allowed to self-administer amiloride nasal spray at 0.2, 0.4, and
      0.6 mg doses of amiloride. A series of timed blood samples (0,10, 15, 30, 60 minutes, and 4,
      6, 8, 12 and 24 hours,1mL each time point) will be collected.

      Primary objectives:

        1. To evaluate the pharmacokinetics of amiloride nasal spray at three different doses 0.2,
           0.4, and 0.6 mg in healthy human volunteers.

        2. To calculate the following pharmacokinetic parameters after intranasal administration of
           amiloride: time to reach maximum plasma concentration (Tmax), maximum plasma
           concentration (Cmax), area under the curve (AUC), the volume of distribution (Vd) and
           clearance (CL).
    

Intervention name(s): Amiloride; Amiloride; Amiloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Amiloride Nasal Spray; Amiloride Nasal Spray; Amiloride Nasal Spray
Other intervention name(s): Midamor; Midamor; Midamor
Intervention MeSH terms: Amiloride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Barley and Rice Mixture Effects on Blood Glucose
Condition: Blood Glucose; Dietary Fiber; Hunger
Study type: Interventional

Summary: 
      The purpose of this research was to investigate 5 different formulations of whole grain
      barley and refined white rice against a control of white bread on post-prandial glycemic
      response, as well as self-reported hunger/satiety in a randomized cross-over trial.
    

Detailed description: 
      Beta-glucan-rich barley has been shown to improve glycemic response, reduce hunger and
      increase satiety. Nutrient-dense grain mixtures that include a new cultivar of barley
      (Sustagrain, Ardent Mills, LLC) with exceptionally high dietary fiber content may help
      individuals meet their dietary fiber needs while minimizing the rapid increase in blood
      glucose following the consumption of a refined grain product. The primary objective of this
      study was to compare the effects of five different test meals containing varying amounts of
      whole-grain barley and refined white rice to white bread on post-prandial blood glucose
      concentrations. A secondary aim was to evaluate changes in self-reported hunger and satiety
      following the consumption of each treatment. This study was a single-site, blinded,
      randomized crossover trial among 24 healthy adults. Each participant consumed the following
      treatments: 100% Sustagrain barley flakes, 100% Sustagrain steel cut barley , an 80/20
      rice-steel cut Sustagrain barley mix, a 50/50 rice-steel cut Sustagrain barley mix, 100%
      rice, and white bread.
    

Intervention name(s): 100% steel cut barley; 100% barley flakes; 50/50 rice-barley mix; 80/20 rice-barley mix; 100% rice; white bread
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): 25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).; 25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).; 25 g of available carbohydrate was delivered to participants via a 50/50 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).; 25 g of available carbohydrate was delivered to participants via a 80/20 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).; 25 g of available carbohydrate was delivered to participants via Goya medium grain white rice; 25 g of available carbohydrate was delivered to participants via Sara Lee Classic White Bread (Bimbo Bakeries USA, Inc.)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Otherwise healthy male and female adults
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: glucose; dietary fiber; glycemia; whole grain
Hemodynamic and Respiratory Function in Healthy Pregnant Women
Condition: Healthy
Study type: Observational

Summary: 
      This study looks at hemodynamic and respiratory function in healthy pregnant women; it is a
      longitudinal study.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy pregnant women
      
Keywords: Hemodynamic and respiratory changes and pregnancy; Healthy pregnant women
Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.
Condition: Breast Neoplasm
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the ability of preoperative biopsy to predict
      correctly pathologic complete response in breast cancer patients with complete clinical
      response after neoadjuvant chemotherapy.
    

Detailed description: 
      Breast cancer patients who received neoadjuvant chemotherapy and is predicted to have
      achieved pathologic complete response (pCR) on MRI will enrolled. The enrolled patients will
      undergo either US-guided multiple core needle biopsy or US-guided vacuum-assisted biopsy of
      the tumor bed where it had been marked with an indicator (clip). The patient will undergo
      subsequent wide excision of the tumor bed. Histopathologic findings of the biopsy and the
      surgical specimen will be compared for pCR, and the ability of preoperative biopsies to
      predict pCR will be evaluated.
    

Intervention name(s): Minimally-invasive biopsy; wide excision
Intervention type(s): Procedure; Procedure
Intervention description(s): Intervention (core needle biopsy (14G) or vacuum-assisted biopsy(10G)) for complete clinical response (cCR) or near-cCR predicted by MRI.; Surgical wide excision of the biopsied area.
Other intervention name(s): vacuum-assisted biopsy; core-needle biopsy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison of pathological findings for residual tumor between minimally-invasive biopsy procedure and subsequent wide excision of the biopsied area
Masking: None (Open Label)
Primary purpose: Diagnostic
Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes
Condition: Atherosclerosis; Leukocyte Activation Disorder; Type 2 Diabetes Mellitus; Familial Combined Hyperlipidemia
MeSH terms: Atherosclerosis; Hyperlipidemia, Familial Combined; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional

Summary: 
      In this study, we will investigate both inflammatory systems in healthy volunteers and
      patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH)
      and familial combined hyperlipidemia (FCH)) during an OGTT.
    

Detailed description: 
      Cardiovascular disease (CVD) is number one killer in the Netherlands. Insulin resistance and
      dyslipideima are the main causes of CVD. Recently, we have shown that there is an acute
      leukocyte activation after an oral glucose tolerance test (OGTT) in patients with
      newly-diagnosed diabets mellitus type 2 (T2DM). Leukocyte activation is an important and
      obligatory aspect in the process of atherosclerosis. Complement system is another important
      inflammatory component in atherosclerosis, which becomes activated in the postprandial phase.

      In this study, we will investigate both inflammatory systems in healthy volunteers and
      patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH)
      and familial combined hyperlipidemia (FCH)) during an OGTT.
    

Intervention name(s): OGTT
Intervention type(s): Dietary Supplement
Intervention description(s): Oral glucose tolerance test (OGTT) with 75 g of oral anhydrous glucose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic