bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Acetazolamide on Sleep Related Breathing Disturbances in Patients With Respiratory Disease at Altitude
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day)
      vs. placebo on sleep related breathing disturbances at altitude in patients with COPD.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect
      of acetazolamide (375 mg per day) vs. placebo on sleep related breathing disturbances in
      lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants
      living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the
      Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day
      (or placebo), will be administered 24 hours before departure at 760 m and during the stay at
      altitude. Outcomes will be assessed during the stay at 3200 m.

      Sleep related breathing disturbances will be evaluated by respiratory polygraphy.

      An interim analysis will be carried out when 90 patients will have completed the study or
      after the first year. The Peto's method will be used to correct the P-values.
    

Intervention name(s): ACETAZOLAMIDE oral capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m; Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: sleep related breathing disturbances; respiratory polygraphy; airway disease; emphysema; acetazolamide; altitude; nocturnal pulse oxymetry
UFPTI 2105-BR05: Improving Breast Radiotherapy Setup and Delivery Using Mixed-Reality Visualization
Condition: Breast Cancer
Study type: Interventional

Summary: 
      The purpose of this study is to compare the accuracy, set-up time, and amount of image-guided
      radiotherapy (IGRT - a system that helps line up the radiation beam with the tumor for
      treatment) needed when mixed-reality guided radiotherapy is used for treatment set-up.
    


Intervention name(s): HoloLens v2
Intervention type(s): Device
Intervention description(s): The HoloLens v2 will be used to access the participant's hologram & set the participant up for treatment. Standard of care methods will be utilized to confirm treatment set-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter
Condition: Cerebral Oxygenation
Study type: Interventional

Summary: 
      -  Due to the increased risk of brain damage, continuous monitoring of the cerebral
           oxygenation is interesting. We will evaluate the capability of the INVOS Oximeter to
           detect induced changes in the cerebral regional saturation.

        -  The purpose of the study is to investigate our hypothesis that a particular CPAP flow
           pressure optimizes the regional cerebral oxygenation.
    

Detailed description: 
      Preterm infants are at increased risk of brain damage compared with term infants, and
      cerebral hypoxia is considered to have an important role. The preterm infants are at
      increased risk of respiratory distress, episodes with low oxygenation, mechanical
      ventilation, risk of hypocapnia and labile or low blood pressure. These conditions can affect
      the microcirculation and hence the oxygenation of the brain. Hyperoxia is also a point of
      interest, since high levels of oxygen can cause vasoconstriction. Preterm infants is often
      treated with CPAP (Continuous positive airway pressure), but the effect of different flow
      pressures on the regional cerebral oxygenation is not known.

      The investigators will examine the normal physiological response of the brain in a group of
      preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants to the
      commonly used treatment in neonatology, CPAP (Continuous positive airway pressure).

      The investigators will do dynamic research with continuously monitoring of the cerebral
      oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)).
      INVOS® is the first NIRS-based oximeter CE-approved for hospital use in Denmark.

      There will be no follow-up.
    

Intervention name(s): Cerebral NIRS Oximetry + CPAP
Intervention type(s): Procedure
Intervention description(s): CPAP flow pressure is increased for 5 minutes then 15 minutes with CPAP pressure at baseline. Repeated once
Other intervention name(s): INVOS 5100C Oximeter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Preterm; Neonate; Newborn; Cerebral oxygenation; CPAP
Aquatic Exercise Study for Breast Cancer Patients With Lymphedema
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      The purpose of this study is to determine what effects aquatic exercise has on participants
      with Lymphedema.
    

Detailed description: 
      This pilot study will examine the effectiveness of aquatic exercise in reducing Lymphedema.
      The study is designed for breast cancer patients who have developed Lymphedema following
      cancer treatment. Potential study participants should have explored conventional treatments
      such as decongestive therapy and lymph drainage massage before joining the study.

      There are two groups that the participants may choose from until enrollment for the group has
      reached its capacity.The active arm of the study will attend 12 one-hour aquatic exercise
      classes and classes will be held in an indoor heated pool. There is no cost to the
      participants.Both the active arm and the control group (not attending aquatic exercise
      classes) will have 3 measurement assessments that will compare the circumference and
      volumetric measurement of arms, as well as height, weight and body mass index (BMI).

      Both group will fill out a program questionnaire. Quality of life survey taken at baseline,
      week 6, month 6 and 12 will be compared. A follow up questionnaire will be completed at 6 and
      12 month intervals, and annually for five years.
    

Intervention name(s): Aquatic Exercise arm
Intervention type(s): Behavioral
Intervention description(s): Participants will attend 12 classes of aquatic exercise program (2-3 classes/weekly). Each one hour class is held in warm water pool which is 89 degrees and 3.5'-4'deep.Classes include low impact, dynamic movements for warm up, stretching and breathing exercises, upper and lower body resistance training, and cool down activities. Participants will be evaluated for Circumference & volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week. Participant will complete a quality of life survey (QOL)at baseline, 6 week, 6 and 12 month.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphedema; Aquatic Exercise; Breast Cancer
Efficacy of Candesartan on Reducing Blood Pressure in Insulin-Resistant, Obese Patients With Hypertension.
Condition: Obesity; Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the efficacy of candesartan, once daily (QD),
      combined with hydrochlorothiazide to lower blood pressure in insulin-resistant, obese
      patients with hypertension.
    

Detailed description: 
      Abdominal obesity is a major risk factor for insulin resistance and the development of type 2
      diabetes. It is associated with sodium retention, left ventricular hypertrophy and elevated
      markers of inflammation and is an important predictor of cardiovascular morbidity and
      mortality. Activation of the sympathetic nervous system and the renin angiotensin aldosterone
      system are both involved in the development of hypertension in obese individuals.
      Hypertension in obese individuals is often associated with dyslipidemia, hyperinsulinaemia
      and impaired glucose tolerance.

      In order to decrease the cardiovascular risk of obese hypertensive patients, therapy should
      not only be directed to lowering blood pressure values but also to improvement of their
      metabolic situation. As it is possible that antihypertensive treatment based on an
      angiotensin receptor antagonist (like candesartan) might be superior to beta-blocker or
      calcium channel blocker therapy in preventing diabetes, a combination of candesartan with
      already existing insufficiently effective beta-blocker or calcium channel blocker therapy
      will be used in this study.
    

Intervention name(s): Candesartan and Hydrochlorothiazide; Hydrochlorothiazide (HCT)
Intervention type(s): Drug; Drug
Intervention description(s): Candesartan 8 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for 2 weeks; increased to Candesartan 16 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 24 weeks.; Candesartan placebo-matching tablets and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 24 weeks.
Other intervention name(s): BLOPRESS PLUS®
Intervention MeSH terms: Hydrochlorothiazide; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Drug Therapy; Blood Pressure; Insulin, Resistant
Association Between Confocal Laser Endomicroscopic (CLE) Features and Colorectal Mucosal Microbiome
Condition: Colorectal Neoplasia; Colorectal Inflammation; Hyperplasia; Mucosal Microbiome
MeSH terms: Inflammation; Hyperplasia
Study type: Observational

Summary: 
      The purpose of this study is to determine whether an association between endomicroscopic
      pattern and colorectal mucosal microbiome exists.
    

Detailed description: 
      The gut microbiome plays a pivotal role in the intestinal pathophysiology. The mucosal
      microbiome is in the front face of microbiome-host cross-talk. Confocal laser endomicroscopy
      (CLE) can provide realtime mucosal images during ongoing endoscopy. We hypothesized that the
      mucosal pattern, here evaluated by endomicroscopy, may constitute specific microbiome niches
      and participate the evolvement of the mucosal microbiome.
    

Intervention name(s): the mucosal microbiome in the biopsy specimen was analysed
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient
        department are the study population of this study.
      
Biospecimen description: 
      The mucosal metagenome was obtained from biopsy specimen.
Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy
Condition: Postoperative Pain; Hysterectomy
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Intravenous patient-controlled analgesia (PCA) is a popular technique for postoperative pain
      management. Although several drugs are recognized as effective therapeutic options, optimal
      selection of drugs in hysterectomy patients underwent different anesthesia treatments remains
      unknown explicitly. The investigators hypothesized that butorphanol and tramadol can produce
      different analgesic effects with intravenous PCA after abdominal hysterectomy.
    


Intervention name(s): Saline; Butorphanol tartrate; Tramadol Hydrochloride; Saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Saline infusion adjunct to morphine PCA pump; Butorphanol was delivered at a continuous infusion manner adjunct to morphine PCA pump; 100mg tramadol was used preemptively to morphine PCA pump; Preemptive saline as a control group to tramadol one
Other intervention name(s): SA; BT; TH; PS
Intervention MeSH terms: Tramadol; Butorphanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain, Postoperative; Analgesics, Opioid; Analgesia, Patient-Controlled; Pain Measurement
Concentration/Meditation Limits Inflammation
Condition: Autoimmune Diseases
MeSH terms: Autoimmune Diseases; Inflammation
Study type: Interventional

Summary: 
      Auto-immune diseases are characterized by an inappropriate inflammatory response against
      tissues in the body and represent a major health care burden. Pro-inflammatory cytokines such
      as TNF-α, IL-6 and IL-1β play a central role in the pathophysiology of many auto-immune
      diseases. Innovative therapies aimed at limiting pro-inflammatory cytokine production in a
      more physiological manner are warranted. In previous research conducted in an individual
      known as "the iceman", the investigators found that, through a autodidact
      concentration/meditation technique, he appears to mount a controlled stress response,
      characterized by activation of the sympathetic nervous system and enhanced production of
      cortisol, both of which are known to result in immunosuppression. In accordance, while
      practicing this concentration/meditation technique, the inflammatory response during human
      endotoxemia (lipopolysaccharide [LPS] administration) was remarkably low in this individual.
      Therefore, this technique could provide a novel means of controlling the inflammatory
      response. However, the aforementioned results were obtained in just one subject, and hence
      can not serve as scientific evidence for the effectiveness of the concentration/meditation
      technique. The iceman claims that he can teach this technique to other subjects within a
      relatively short time frame. Therefore, in the present study the investigators wish to
      investigate the effect of concentration/meditation on autonomic nervous system activity and
      the inflammatory response during experimental human endotoxemia in a controlled manner, by
      comparing a group of subjects that are trained by "the iceman" and practice the
      concentration/meditation technique with a group of subjects which do not.
    


Intervention name(s): Lipopolysaccharide; Concentration/meditation
Intervention type(s): Drug; Behavioral
Intervention description(s): LPS is used to elicit an inflammatory response in all subjects.; A self-taught concentration/meditation technique that Mr Wim Hof developed himself, characterized by cycles consisting of a few minutes of hyperventilation followed by breath holding for up to 1-2 minutes and deep concentration (mindset).
Other intervention name(s): Lipopolysaccharide (LPS) E. Coli 113:H 10:K negative; Wim Hof Method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Endotoxemia; Autonomic Nervous System; Inflammation; Meditation; Concentration; Iceman; LPS; Cortisol; Catecholamines
Post Extubation Delirium and End-tidal Sevoflurane Concentration
Condition: Delirium on Emergence
MeSH terms: Delirium; Emergence Delirium
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the incidence of emergence delirium will be
      reduced when end-tidal concentration of sevoflurane decreases.
    

Detailed description: 
      Sevoflurane induction and maintenance were selected. Intubation was performed after lidocaine
      spray on vocal cord. After that, an effective caudal or brachial plexus block was performed.
      End-tidal concentration of sevoflurane was maintained at 2.5%. Spontaneous respiratory was
      maintained. Sevoflurane was stopped after the end of surgery. Patients were randomly assigned
      to 2 groups: high concentration group (Group HC, end-tidal concentration of sevoflurane when
      extubating >=0.5%) and low concentration group (Group LC, end-tidal concentration of
      sevoflurane when extubating <0.5%). Patients in Group LC were extubated when they coughed or
      purposeful movement appeared. The patients whose end-tidal concentration of sevoflurane >=
      0.5% were excluded. Patients in Group HC were extubated when any of the criteria was met:
      1.the patient coughed or purposeful movement appeared 2.end-tidal concentration of
      sevoflurane decreased to 0.5%. A trained nurse (blind to groups) recorded PAEDs scores in
      PACU.
    

Intervention name(s): sevoflurane; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): extubation when end-tidal concentration of sevoflurane < 0.5%; extubation when end-tidal concentration of sevoflurane >= 0.5%
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: sevoflurane; emergence delirium; preschool
Effect of Spirulina on Zinc, Vitamin E and Linoleic Acid Levels in Palm Skin Following Chronic Exposure to Arsenic
Condition: Arsenical Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional

Summary: 
      Patients of arsenical keratosis may be treated with spirulina. Is this improvement related to
      the levels of zinc, vitamin E and linoleic acid at the site of the keratosis (palm)? To
      understand this, patients of palmer arsenical keratosis (n=10), arsenic exposed controls
      (n=10) and healthy volunteers (n=10) will be treated with spirulina powder 10 g/day orally
      for 12 weeks. Skin extracts will be collected both before and after supplementation from the
      palm and dorsum for estimation of zinc, vitamin E and linoleic acid levels.
    

Detailed description: 
      Patients of arsenical keratosis remain untreated due to unavailability of effective drug. To
      find out an effective drug, the pathogenesis of keratosis should be understood. Spirulina is
      one of the dietary supplements, that improves the symptoms of keratosis. Is this improvement
      related to the levels of zinc, vitamin E and linoleic acid at the site of the keratosis
      (palm)? Ten patients of moderate palmer arsenical keratosis will be treated with spirulina
      powder 10 g/day orally for 12 weeks. Skin extracts will be collected both before and after
      supplementation from the palm and dorsum using a mixture of chloroform and ethanol. Zinc,
      vitamin E and linoleic acid levels will be estimated from the extracts. Similar protocol of
      spirulina administration and the collection of skin extracts will be done in arsenic exposed
      controls (n=10) and healthy volunteers (n=10).
    

Intervention name(s): Spirulina
Intervention type(s): Dietary Supplement
Intervention description(s): 10 g/day orally for 12 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Arsenic; Keratosis; Linoleic acid; Palm; Spirulina; Vitamin E; Zinc
Dextrose Effect on Postoperative Nausea and Vomiting (PONV)
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The aim of this study to assess which time and dose of dextrose solution more effective in
      decreasing postoperative nausea and vomiting.
    

Detailed description: 
      All patients signed informed consent after excluding patients not candidate for the
      study.patients were divided to three groups, taking either 0.9% saline as control group(group
      C), dextrose 5%(group D5) or dextrose 10%(group D10).
    

Intervention name(s): Dextrose 5% in water; Dextrose 10%; Saline placebo
Intervention type(s): Other; Other; Other
Intervention description(s): One hour before operation, patients were given dexrose 5%100/hour only for 2 hours to end at about middle of surgery; One hour before operation, patients were given dexrose 10 %100/hour only for 2 hours to end at about middle of surgery; One hour before operation, patients were given normal saline100/hour only for 2 hours to end at about middle of surgery
Other intervention name(s): Normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Efficacy and Safety of Acupuncture for Functional Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25
      has the same effect as lactulose in unaided self-defecation frequency of a week and has
      better effect in symptoms improvement (in press). The object is to evaluate whether
      acupuncture is effective for functional constipation. As an explanatory research, it took one
      single point as its intervention and sham acupuncture as its control group (patients were
      blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized
      controlled trial to further evaluate whether acupuncture is more effective than routine
      treatment. Acupuncture prescriptions used in this trial are individually prescribed according
      to syndrome differentiation, which can improve clinical effect. .
    

Detailed description: 
      functional constipation,acupuncture,effects and safety,pragmatic RCT
    

Intervention name(s): acupuncture; mosapride citrate
Intervention type(s): Other; Drug
Intervention description(s): Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks.; 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
Other intervention name(s): acupuncture and moxibustion; mosapride citrate,made in China
Intervention MeSH terms: Mosapride; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Functional constipation