bioihbjkbjnl/mcl2 huggingface dataset:
Wearable Blood Pressure Monitoring
Condition: Blood Pressure
Study type: Observational

Summary: 
      The goal of this study is to develop and validate a new non-invasive medical instrumentation
      technology for blood pressure measurement.
    

Detailed description: 
      The goal of this study is to develop and validate a new non-invasive medical instrumentation
      technology for assessing haemodynamic status measured from the fingertip using oscillometry.
      . As the finger pressing pressure is ramped up and then slowly down, an oscillometric
      response is recorded. From this signal the mean arterial pressure is found from which
      systolic and diastolic pressure is computed along with the full pressure waveform.
    

Intervention name(s): sphygmomanometer, SpyghmoCor, CNAP500
Intervention type(s): Device
Intervention description(s): blood pressure is measured with developed new non-invasive technology, oscillometry from the fingertip, and compared to non-invasive standard blood pressure measurement using a standard sphygmomanometer/SpyghmoCor device/CNAP500 device.
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        33 volunteers (weight: mean 77 kg [range:48 to 117 kg]; height: mean 176 cm [range: 161 to
        194 cm]; age: mean 32 [range: 23 to 75 years], 8 females) The subjects had a blood pressure
        range (DBP: 56 to 84 mmHg, SBP: 93 to 146 mmHg) and four of them were on blood pressure
        medication. Three measurements were performed on both the reference and the experimental
        device from which an average was calculated

        32 volunteers (age: mean 47 years [range: 24 to 83 years], 5 women). The validation study
        was carried out at Turku University Hospital. For reference manual auscultation was
        performed by two trained observers, and the maximum acceptable difference between the
        readings from the observers was 4 mmHg for both SBP and DBP. After an initial test
        measurement, three measurements were taken in a cyclical manner one device after another,
        both with the finger device and by auscultation.
Effectiveness of Cosmetic Therapy on Self-esteem and Depression for Elderly Residents in Long-Term Care Institutions
Condition: Long-Term Care; Aged
MeSH terms: Depression
Study type: Interventional

Summary: 
      Cosmetic therapy provides a psychological effect on the elderly, improving their
      self-confidence and social participation. This study was conducted to investigate the
      effectiveness of cosmetic therapy to enhance the self-esteem and reduce depression of elderly
      residents in long-term care institutions. We expect that a 6-week cosmetic therapy will
      improve the elderly's mental health, including depression and self-esteem.
    


Intervention name(s): Cosmetic therapy
Intervention type(s): Behavioral
Intervention description(s): The cosmetic therapy in this study is once a week, 60 minutes each section for a total of 6-week. Cosmetic therapy uses the teaching materials to teach the subjects skincare and makeup operation steps and use the 10-minute limb stretching to relax their minds before the activity, and then lead the research subjects to use cotton pads to apply lotion and lotion. , female subjects used powder, eyebrow pencil, and lipstick (or lip balm) to complete weekly different-themed activities and hairstyling, while men performed weekly different theme activities and hairstyling.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Elderly Residents; Long-Term Care Institution; Depression; Self-esteem; Cosmetic Therapy
DAW1033D in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Obstructive sleep apnea (OSA) is common and has major health implications but treatment
      options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle
      activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared
      to normal subjects. In this protocol the investigators will test the effect of DAW1033D
      administered before sleep on OSA phenotype traits and OSA severity during sleep.
    


Intervention name(s): Placebo oral capsule; DAW1033D oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Placebo before sleep; DAW1033D before sleep
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Salvage HIFU for Local Recurrence in the Prostatic Bed After Prostatectomy and External Beam Radiation Therapy : Preliminary Results
Condition: Prostatic Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Study type: Observational

Summary: 
      Retrospective monocentric analysis performed on patients treated with salvage HIFU for
      isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage
      or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free
      survival), the adverse events and urinary incontinence will be evaluated.
    


Intervention name(s): Retrospectively review of medical data in patients treated by Salvage HIFU for isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage or adjuvant EBRT
Intervention type(s): Other
Intervention description(s): Patients were treated using dedicated post-EBRT parameters (5-s pulse, 5-s waiting period, 90% of the acoustic power). Between July 2005 and November 2018, at Edouard Herriot Hospital (Lyon, France), 22 consecutive patients were treated with S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence were retrospectively reviewed.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Between July 2005 and November 2018, at Edouard Herriot Hospital (Lyon, France), 22
        consecutive patients were treated with S-HIFU for a local recurrence after radical
        prostatectomy and salvage or adjuvant EBRT. The oncological outcomes (treatment
        failure-free survival, progression-free survival), the adverse events and urinary
        incontinence were retrospectively reviewed.
Neuroprotection Impact of Cyclosporin A in Cerebral Infarction
Condition: Stroke
MeSH terms: Cerebral Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to determine whether a single injection of CsA after
      intravenous thrombolysis can significantly decreased the volume of cerebral infarction at day
      30 ± 15 assessed with Flair MRI.

      Secondary objectives are to determine whether a single injection of CsA after intravenous
      thrombolysis is safe and effective regarding to death and disability.
    


Intervention name(s): Ciclosprin A; Injectable Saline Solution.
Intervention type(s): Drug; Drug
Intervention description(s): The dose in this study was 2 mg / kg, administered within 15 min after beginning of thrombolysis. The treatment of the study consists of a single bolus injection. This dose was chosen according to the results of tolerance in myocardial infarction and unknown pharmacodynamic and safety data; Saline Solution is administered once 15 min after thrombolysis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Volume of cerebral infarction; Stroke; CsA; NIHSS
Effect of Escalating Doses of a Novel Viscous Polysaccharide on Postprandial Glycemia
Condition: Blood Glucose, Postprandial
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To determine palatability and extent to which escalating doses of a novel highly viscous
      polysaccharide [NVP] reduces postprandial glycemia when added to a liquid and a solid meal.
    


Intervention name(s): PolyGlycopleX (PGX); PolyGlycopleX (PG); PolyGlycopleX; Control; Second Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2.5 grams of PGX; 5.0 grams of PGX; 7.5 grams of PGX; 0g of PGX; 0g of PGX
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: viscous; fibre; polysaccharide; blood glucose; post prandial
Protein Requirements for Active Adolescent Females
Condition: Increased Metabolic Requirement; Healthy
Study type: Interventional

Summary: 
      Protein requirements in active individuals have been suggested to be greater than the current
      recommended dietary allowance (RDA).

      Nutritional requirements for dietary amino acids in adolescents have traditionally been
      determined utilizing the nitrogen balance technique, which is prone to underestimating
      protein requirements. As a result, there is a need to re-evaluate recommendations in order to
      characterize how dietary amino acid needs may be modulated by physical activity.

      Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique
      have suggested that protein requirements in young men are at least 50% higher than the RDA
      based on nitrogen balance data.

      The purpose of this study is to measure the protein requirement in adolescent, females using
      the IAAO technique in the presence of a variable intensity exercise stimulus.
    


Intervention name(s): Amino Acid Intake
Intervention type(s): Dietary Supplement
Intervention description(s): Amino acid intakes will be varied at 0.2-2.67 g/kg/d
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Dairy Fat on Plasma Phytanic Acid in Human
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      The aim of the study is to investigate if cow feeding regimes affects concentration of plasma
      phytanic acid and risk markers of the metabolic syndrome in human.
    


Intervention name(s): milk fat
Intervention type(s): Dietary Supplement
Intervention description(s): 45 g milk fat per day in 4 weeks
Other intervention name(s): yellow group; Green group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer
Condition: Breast Cancer; Pain; Perioperative/Postoperative Complications
MeSH terms: Breast Neoplasms; Postoperative Complications
Study type: Observational

Summary: 
      RATIONALE: New surgery techniques may lessen pain after breast surgery. It is not yet known
      whether tumescent mastectomy or standard mastectomy results in less pain in women with breast
      cancer.

      PURPOSE: This clinical trial is studying pain after tumescent mastectomy compared with pain
      after standard mastectomy in women with stage I, stage II, or stage III breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To compare post-operative pain after tumescent vs standard mastectomy in women with
           stage I-III breast cancer.

      Secondary

        -  To compare the total time of operation from incision to completion of wound closure.

        -  To compare the time of operation from first incision to completion of skin flaps.

        -  To compare the total estimated blood loss.

        -  To compare the number of days the Jackson-Pratt drain is left in place under skin flaps
           with wound drainage > 30 mL/24 hours.

        -  To compare the incidence of wound complications such as skin necrosis, hematoma,
           cellulitis, abscess, and seroma between groups.

      OUTLINE: Patients are grouped according to which surgeon provided their evaluation and
      treatment recommendations.

        -  Group 1: Patients undergo standard mastectomy.

        -  Group 2: Patients undergo tumescent mastectomy. All patients receive standardized
           post-operative pain management comprising morphine sulfate for analgesia or an
           equivalent dose of hydromorphone hydrochloride for 24 hours following surgery. Patients
           then receive 1-2 oral acetaminophen/oxycodone hydrochloride combination tablets (or a
           comparable amount of another narcotic/acetaminophen combination) every 6 hours as
           needed. Pain is assessed using the Short-form McGill Pain Questionnaire (SF-MPQ).
    

Intervention name(s): therapeutic conventional surgery
Intervention type(s): Procedure
Intervention description(s): Patients undergo tumescent or standard mastectomy
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult (age 18 or more) women with histologic diagnosis of stage 0, I, II, III breast cancer
        undergoing mastectomy.
      
Keywords: perioperative/postoperative complications; pain; ductal breast carcinoma in situ; invasive ductal breast carcinoma; invasive lobular breast carcinoma; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer
The Effect of Vitamin D Supplementation on Psoriasis Severity
Condition: Psoriasis; Vitamin D Deficiency
MeSH terms: Psoriasis; Vitamin D Deficiency
Study type: Interventional

Summary: 
      The study evaluates the effect of oral vitamin D supplementation on the severity of psoriasis
      measured by Psoriasis Area Severity Index (PASI) in adults with lower vitamin D levels. Half
      of the participants will receive vitamin D, while the other half receive placebo.
    

Detailed description: 
      Studies have indicated an association between lower levels of vitamin D and increased risk of
      psoriasis. This study investigate if vitamin D supplementation can reduce the severity of the
      skin disease as measured by Psoriasis Area Severity Index (PASI), as well as positively
      influence the cardiometabolic profile and skin microbiota of persons with psoriasis through a
      winter season.

      Consenting participants will be randomized to high dose vitamin D (20.000 IU/week) versus
      placebo for four months. The participants will be recruited based on their 25-hydroxyvitamin
      D (25(OH)D)-measurements in the 7th survey in the Tromsø study where 21.083 subjects
      attended.

      In order to assure sufficient study participation we will (in season 2, winter 2018/19)
      include 20-40 persons from the general population in Tromsø aged 20-79, who did not partake
      in Tromsø 7, through advertisement and contact with patient organizations.
    

Intervention name(s): 25-Hydroxyvitamin D; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Capsules containing 20 000 IU 25-hydroxyvitamin D given orally: five capsules the first day and thereafter one capsule every week for 4 months (average daily dose approximately 3.000 IU); Five capsules the first day and thereafter one capsule every week for 4 months.
Other intervention name(s): Dekristol
Intervention MeSH terms: Hydroxycholecalciferols; Calcifediol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to high dose vitamin D (20.000 IU/week) versus placebo for 4 months.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Transplantation of Ex-vivo Expanded Cord Blood Stems Cells
Condition: Malignant Haematological Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This program offers the opportunity to receive an allogeneic transplant to try to control the
      malignant hematologic in the absence of acceptable conventional donor and with a risk-benefit
      ratio equivalent to that which would be expected with a transplant from a more conventional
      donor.

      An economy of means in that this method could serve as an alternative to 2 units of placental
      blood transplantation. The current cost of disposal of a unit of placental blood from a bank
      is approximately 22000 € (Source: Biomedicine Agency, 2007 rates). The amplification process
      as controlled by "EFSAL" is 12000 €. Therefore, buying a unit and ex-vivo amplification is
      more economical. Moreover, the availability of placental blood is not infinite, and the use
      of one unit per patient will also save resources that can be valuable for certain groups of
      patients.

      In the longer term, methods of amplification of specific immunocompetent cells (from the
      fraction of CD 34 neg cells) are already being evaluated in the laboratory. They allow to
      consider a faster recovery, better and more targeted, including cells against the disease for
      which transplantation is performed.
    

Detailed description: 
      This is a multicenter prospective non randomized phase 2 clinical trial.

      The primary objective is defined by getting a neutrophil count above 500/ml for 3 consecutive
      days at day 42 after transplantation, in association with complete or partial chimerism on T
      cells (10 % to 90%).

      The secondary objectives are:

        -  the feasibility of expansion,

        -  tolerance immediate injection of a graft amplified,

        -  the payback of a platelet count> 20 000/microlitre without transfusion,

        -  Incidence of graft loss or rejection within 6 months following transplantation,

        -  the incidence of acute and chronic GVHD,

        -  the mortality rate associated with transplantation,

        -  the incidence of relapse of hematologic malignancies,

        -  Overall survival,

        -  Disease-free survival at 1 year post transplant.
    

Intervention name(s): allogeneic transplant
Intervention type(s): Other
Intervention description(s): ex vivo amplification of a unit of placental blood for transplantation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: allo graft; cord blood; expansion; reduced-intensity conditioning
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the single-dose relative bioavailability of Dr.
      Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril
      hydrochloride capsules, under non-fasting (fed) conditions.
    

Detailed description: 
      Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's
      Laboratories, Ltd. and Novartis (Lotrel®) 10 mg Amlodipine Besylate / 20 mg Benazepril
      Hydrochloride Capsules in Healthy Adult Male Volunteers under non-fasting (fed) Conditions
    

Intervention name(s): Amlodipine Besylate / Benazepril Hydrochloride
Intervention type(s): Drug
Intervention description(s): 10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules
Other intervention name(s): Lotrel® (10 mg Amlodipine Besylate / 20 mg Benazepril; Hydrochloride Capsules)
Intervention MeSH terms: Amlodipine; Benazepril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; 10 mg Amlodipine besylate/20 mg benazepril hydrochloride capsules; Crossover
Bioequivalence Study of Ibuprofen 200 mg Soft Gel Capsules of Dr. Reddy's Laboratories Limited Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of ibuprofen 200 mg
      gelcaps (test) versus Advil liquigels (reference) administered as 1 x 200 mg gelcap under fed
      conditions.
    

Detailed description: 
      Randomized, 2-way crossover, bioequivalence study of Ibuprofen 200 mg gel capsules and Advil
      liquigels 200 mg gel caps administered as 1 x 200 mg gel capsule in healthy subjects under
      fed conditions.
    

Intervention name(s): Ibuprofen
Intervention type(s): Drug
Intervention description(s): Ibuprofen 200 mg gel capsules of Dr. Reddy's Laboratories Limited
Other intervention name(s): Advil liquigels 200 mg gel capsules
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Ibuprofen