bioihbjkbjnl/mcl2 huggingface dataset:
A Crossover Study on the Blinding Effect of a New Pragmatic Placebo Needle
Condition: Device Ineffective
Study type: Interventional

Summary: 
      Placebo needle is a useful tool to assess the efficacy of acupuncture. Investigators have
      applied a new kind of placebo needle in large scale acupuncture clinical trials, which named
      as pragmatic placebo needle. Compared with other placebo needles used in acupuncture trials,
      this pragmatic placebo needle shows several advantages: the outlook closer to traditional
      acupuncture needles, no restriction to needle depth of true needle, simple to manipulate and
      more economical. However, its blinding effect is not yet validated. The primary objective of
      this trial is to validate the blinding effect of the new pragmatic placebo needle; the
      secondary objective is to explore factors influencing the blinding effect of the placebo
      needles.
    

Detailed description: 
      blinding refers to subject blinding
    

Intervention name(s): real needle- placebo needle; placebo needle - real needle
Intervention type(s): Device; Device
Intervention description(s): All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles.; All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: subject blinding; placebo needle
Remote Ischemic Limb Preconditioning In Healthy Volunteers
Condition: Cerebrovascular Disease; Stroke
MeSH terms: Cerebrovascular Disorders
Study type: Interventional

Summary: 
      The investigators would like to determine if remote ischemic leg preconditioning in healthy
      volunteers improves cerebral vasomotor reactivity as measured by breath holding and
      transcranial doppler vasomotor reactivity.
    

Detailed description: 
      This study is to determine if remote ischemic leg preconditioning improves short and long
      term cerebral vasomotor reactivity in healthy volunteers as measured by breath holding and
      transcranial doppler vasomotor reactivity. Previous studies on brachial vasomotor reactivity
      have shown a beneficial effect of remote ischemic preconditioning. It remains uncertain if a
      similar beneficial effect can be reproduced with cerebral vasomotor testing. Many biological
      mechanisms and effector pathways triggered by preconditioning have demonstrated endothelial
      protection and beneficial vascular effects.
    

Intervention name(s): 4x 5min Limb Preconditioning; 3x 10min Limb Preconditioning; 3x 10min Sham Preconditioning
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): A blood pressure cuff is placed over the upper thigh of the participant(s) and inflated to 30 millimeters of mercury (mmHg) above systolic blood pressure. The loss of pedal pulses is confirmed by palpation. The cuff remains inflated for 5min and is followed by 5 minutes of reperfusion/rest. This will be repeated 4 times.; A blood pressure cuff is placed over the upper thigh of the participant(s) and inflated to 30 mmHg above systolic blood pressure. The loss of pedal pulses is confirmed by palpation. The cuff remains inflated for 10min and is followed by 5 minutes of reperfusion/rest. This will be repeated 3 times.; A blood pressure cuff is placed over the upper thigh of the participant(s) and inflated to 40 mmHg, sufficient to apply pressure but not affect blood flow. The presence of pedal pulses is confirmed by palpation. The cuff remains inflated for 10min and is followed by 5 minutes of rest. This will be repeated 3 times.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Safety of Single Rising Doses and Relative Bioavailability of BI 691751
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single
      rising doses of BI 691751 in healthy male subjects (part I).

      To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution
      (part II)
    


Intervention name(s): BI 691751; BI 691751; Placebo; BI 691751; BI 691751; BI 691751; BI 691751; BI 691751; BI 691751; BI 691751
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral solution BI 691751, dose 6; oral solution; placebo solution; oral solution BI 691751, dose 2; oral solution BI 691751, dose 5; 1 tablet; oral solution BI 691751, dose 3; oral solution BI 69175, dose 4; oral solution BI 691751, dose 7; oral solution BI 69175, dose 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
"Medikidz Explain JIA Comic Book- Hebrew"
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      We believe, that the results of this study will show that children learn from the comic book
      about their disease, and are now more aware and less frightened about it, and increase their
      compliance.
    

Detailed description: 
      We believe, that the results of this study will show that children learn from the comic book
      about their disease, and are now more aware and less frightened about it, and increase their
      compliance. If so, it may promote the use of comic books or other fun educational tool in
      teaching children various other diseases.
    

Intervention name(s): reading comics booklet
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Investigational Oocyte Cryopreservation for Medical and Non Medical Indications
Condition: Infertility, Female; Deferred Childbearing
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      This is a prospective study to assess the long term benefits and outcomes of the existing
      oocyte cryopreservation methods for fertility preservation in women with a potential medical
      or non medical risk of loss of fertility
    

Detailed description: 
      This is a prospective study to assess the long term benefits and outcomes of the existing
      oocyte cryopreservation methods for fertility preservation in women with a potential medical
      or non medical risk of loss of fertility. Women wishing to preserve their oocytes using
      cryopreservation will be informed of the risk and limitations of the procedures involved in
      ovarian hyperstimulation, oocyte recovery, cryopreservation and subsequent viability after
      warming. Women who consent to the procedure will undergo standard controlled ovarian
      hyperstimulation (COH) and oocyte retrieval procedures currently in use for IVF. Following
      harvest all eggs obtained will be evaluated for degree of fragmentation and maturation
      status. The oocytes will be cryopreserved using kits of media and devices currently approved
      for use in the vitrification of fertilized eggs and embryos, and the cryopreserved oocytes
      will be stored for future patient use in a long term storage facility in Minnesota (Reprotech
      Ltd.). Patients with stored oocytes will be contacted annually to determine the outcome of
      any oocyte warming procedures (oocyte thawing, fertilization and embryo transfer).

      We will obtain a structured fertility focused quality of life questionnaire (FertiQol) and
      survey to assess one year after harvest the impact of the process. We will compare cancer
      patients to those patients undergoing oocyte cryopreservation for non-medical reasons
    

Intervention name(s): Investigational Oocyte Cryopreservation
Intervention type(s): Procedure
Intervention description(s): Transvaginal oocyte retrieval under ultrasound guidance
Intervention model: Single Group Assignment
Intervention model description: Investigational Oocyte Cryopreservation
Masking: None (Open Label)
Primary purpose: Supportive Care
A Human Proof of Concept Study for [11C]-RO5011232 as Radiotracer and Study of the Binding of RO4917523 to Human mGlu5 Brain Receptor at Steady-State in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open label, non-randomized, parallel group study will evaluate [11C]-RO5011232 as
      radiotracer for brain mGlu5 receptor occupancy and investigate the binding of RO49917523 to
      human mGlu5 brain receptor at steady-state in healthy volunteers. In Parts I, II and III,
      positron emission tomography (PET) assessments of specific uptake of the radiotracer and
      whole body dosimetry will be made after intravenous injection of [11C]-RO5011232. In Part IV,
      subjects will receive RO4917523 orally daily for 14 days while receiving three single
      intravenous bolus injections of [11C]-RO5011232. The anticipated time on study treatment is
      up to 4 weeks.
    


Intervention name(s): RO4917523; RO5011232
Intervention type(s): Drug; Drug
Intervention description(s): orally daily, 14 days; [11C]-RO5011232 intravenously
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study in RLS patients is designed to assess the affect food has on the absorption,
      distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted
      state and other patients following a high-fat breakfast), and to assess the difference in
      absorption, distribution, metabolism and excretion of ropinirole if patients are given two
      3mg ropinirole tablets versus one 6mg tablet.
    


Intervention name(s): Ropinirole
Intervention type(s): Drug
Intervention description(s): Subjects will receive ropinirole 0.5 mg for first 7 days, 1 mg from Day 8-14, 2 mg from Day 15-21, 3 mg from Day 22-28, 4 mg from Day 29-35, 5 mg from Day 36-42 and 6 mg from Day 43-51.
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetic,; RLS; formulation,; food effect,; controlled release for RLS,; SK&F101468,
Improving Adherence Healthy Lifestyle With a Smartphone Application Based on Adults With Intellectual Disabilities
Condition: Intellectual Disability
MeSH terms: Intellectual Disability
Study type: Interventional

Summary: 
      AIM: Improve adherence to physical activity in people with Intellectual disabilities with a
      Smartphone Application DESIGN: Randomized controlled trial SUBJECTS OF THE STUDY: People with
      intellectual disabilities in Occupational Center ( ASPROMANIS) INTERVENTION: DATA ANALYSIS:
      descriptive statistics, measuring central tendency and dispersion of the variables study.
      Inferential statistics will be made between intervention of key variables and outcome
    


Intervention name(s): multimodal intervention
Intervention type(s): Other
Intervention description(s): All subjects received a multimodal intervention consist in a multimodal program with an educational approach, where therapist advice about benefits of PA during the exercises, to promote PA with brochure-based decalogue
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Intellectual disability; mHealth; App; Physical activity; Adherence
Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Fibroblast Growth Factor 23 (FGF23) is a molecule that has been implicated in the homeostasis
      of phosphorus. Elevated FGF23 levels are well-documented in patients with Chronic Kidney
      Disease (CKD) and are inversely correlated with Glomerular Filtration Rate (GFR). FGF23
      levels are also predictive of progression of CKD and predict mortality in CKD. Although
      studies in normal individuals suggest that phosphorus intake is related to FGF23 levels, the
      effect of dietary and pharmacologic phosphate restriction on FGF23 levels in patients with
      CKD has never been reported. Our objectives are to determine if phosphate reduction through
      the use of non-calcium based phosphate binder will decrease serum FGF23 levels. The
      investigators will also be investigating associations of elevation in FGF 23 levels with
      commonly encountered co-morbidities in CKD patients such as Coronary Artery Disease, Diabetes
      Mellitus, and Hypertension.
    


Intervention name(s): Sevelamer Carbonate
Intervention type(s): Drug
Intervention description(s): Sevelamer 800 mg by mouth three times daily with meals for 3 months
Other intervention name(s): Renvela
Intervention MeSH terms: Sevelamer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Twice-daily SIB Radiotherapy Versus Standard Radiotherapy for Patients With SCLC
Condition: Small Cell Lung Cancer Limited Stage; Radiotherapy
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional

Summary: 
      This trial is a multicenter, perspective, non-blinded, randomized controlled phase 3 trial.
      In order to establish whether the SIB technique can improve the results of twice-daily
      chemo-RT for patients with LS-SCLC, the investigators will primarily compare survival of
      patients treated with standard chemotherapy (cisplatin and etoposide) and either SIB
      twice-daily RT or standard dose twice-daily RT.
    

Detailed description: 
      Three hundred and twenty-six patients with a histological or cytological proven diagnosis of
      SCLC will be recruited from 35 centers in 14 areas including provinces, municipalities and
      autonomous region, from May 2017 to May 2020.
    

Intervention name(s): SIB; Standard
Intervention type(s): Radiation; Radiation
Intervention description(s): patients will recieve twice-daily radiotherapy by simultaneous integrated boosting technique concurrent with chemotherapy; patients will recieve standard twice-daily radiotherapy concurrent with chemotherapy
Other intervention name(s): chemotherapy with etoposide and cisplatin; chemotherapy with etoposide and cisplatin
Intervention MeSH terms: Cisplatin; Etoposide; Etoposide phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: small cell lung cancer limited stage; twice-daily radiotherapy; simultaneous integrated boosting technique
Effects of an mHealth Web-Based Platform (HappyAir) on Adherence to a Maintenance Program After Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Objective: This study aimed to assess the effects of an integrated care plan based on an
      mHealth web-based platform (HappyAir) on adherence to a 1-year maintenance program applied
      after pulmonary rehabilitation in COPD patients.

      Methods: COPD patients from three hospitals were randomized to a control group or an
      intervention group (HappyAir group). Patients from both groups received an 8-week program of
      pulmonary rehabilitation and educational sessions about their illness. After completion of
      the process, only the HappyAir group completed an integrated care plan for 10 months,
      supervised by an mHealth system and therapeutic educator. The control group only underwent
      the scheduled check-ups. Adherence to the program was rated using a respiratory physiotherapy
      adherence self-report (CAP FISIO) questionnaire. Other variables analyzed were adherence to
      physical activity (Morisky-Green Test), quality of life (Chronic Obstructive Pulmonary
      Disease Assessment Test, St. George's Respiratory Questionnaire, and EuroQOL-5D), exercise
      capacity (6-Minute Walk Test), and lung function.
    


Intervention name(s): Pulmonary Care Web-Based App (HappyAir App)
Intervention type(s): Other
Intervention description(s): The HappyAir app reminded the HappyAir group daily to use the app, indicating that they record medication intake, daily exercise time (minutes), level of tiredness after the exercises (good, little tired, very tired, or exhausted), and daily mood (happy, little sad, sad, or very sad). The HappyAir integrated plan was designed as a model of a therapeutic program based on communication that introduced the figure of the therapeutic educator (physiotherapist or respiratory coach) in order to design interventions focused on the patients and their needs, with minimal intervention and presence, making the patients responsible for their self-care and management of their illness. Patient and educator shared responsibility.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Forced Versus Spray Coagulation in Women Undergoing LLETZ-conization for Cervical Dysplasia: a Randomized Trial
Condition: Uterine Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia; Hyperplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      In a randomized clinical trial of 120 women undergoing large loop excision of the
      transformation zone (LLETZ)-conization for cervical dysplasia, two coagulation modes, spray
      versus forced coagulation, will be compared. The primary outcome of the study is time to
      complete hemostasis, secondary outcomes are intraoperative blood loss, postoperative pain,
      and postoperative bleeding complications.
    

Detailed description: 
      Intraoperative bleeding during large loop excision of the transformation zone
      (LLETZ)-conization can be achieved by two modes of electrocoagulation, spray coagulation and
      forced coagulation. Spray coagulation is a superficial coagulation mode, whereas forced
      coagulation is a deep tissue coagulation mode. It is unknown, whether spray or forced
      coagulation is superior regarding intraoperative hemostasis and other outcome Parameters such
      as postoperative bleeding and postoperative pain. Therefore, the investigator designed a
      randomized clinical trial of 120 women undergoing large loop excision of the transformation
      zone (LLETZ)-conization for cervical dysplasia, comparing the two coagulation modes, spray
      coagulation and forced coagulation, The primary outcome of the study is time to complete
      hemostasis measured in seconds, secondary outcomes are intraoperative blood loss measured as
      difference in serum hemoglobin pre- and postoperatively, postoperative pain according to a 10
      step VAS scale, and postoperative bleeding complications, defined as necessity to intervene
      surgically for vaginal bleeding up to 14 days postoperatively. The study Population consists
      of women undergoing LLETZ-conization for histologically proven cervical dysplasia. The study
      hypothesis states that the difference in the mean time until complete hemostais will be at
      least 1/3 shorter in women randomized to spray coagulation. With a study Population of 120
      women, this study has a power of >80% to detect a difference of 1/3 of the mean coagulation
      time until complete hemostais based on an anticipated mean time of 85 seconds.
    

Intervention name(s): Spray; Forced
Intervention type(s): Procedure; Procedure
Intervention description(s): surgical method to achieve intraoperative hemostasis by a superficial electrocoagulation of 80 Watt voltage; surgical method to achieve intraoperative hemostasis by a deep tissue electrocoagulation of 80 Watt voltage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: conization; LLETZ; cervical dysplasia; cervical intraepithelial neoplasia