bioihbjkbjnl/mcl2 huggingface dataset:
Combined Treatment of Arterial Hypertension and Atrial Fibrillation
Condition: Arterial Hypertension; Atrial Fibrillation
MeSH terms: Hypertension; Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is the comparative evaluation of systolic blood pressure (SBP)
      lowering, atrial fibrillation (AF) recurrence and clinical data in patients with
      paroxysmal/persistent AF and resistant/non-resistant hypertension, undergoing AF ablation
      alone or combined with percutaneous renal denervation.
    

Detailed description: 
      On the basis of the eligibility criteria, patients is assigned by the enrolling physician to
      one of two strata. The first stratum includes patients with moderate drug-resistant
      hypertension, defined by the Joint National Committee VII and ESH/ESC guidelines as office BP
      ≥ 140/90 mm Hg and <160/100 mm Hg. The second stratum includes patients with drug-resistant
      hypertension, defined by office BP ≥ 160/100 mm Hg.
    

Intervention name(s): Circumferential PV isolation; PV isolation+renal denervation
Intervention type(s): Procedure; Procedure
Intervention description(s): The left atrium (LA) and pulmonary veins (PVs) are explored through a transeptal approach. Real-time 3D LA maps are reconstructed by using a nonfluoroscopic navigation system. The ipsilateral left and right PVs are encircled in one lesion line by circumferential PV isolation. Radiofrequency energy is delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and is reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion is ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of circumferential PV isolation is PV isolation. Additional ablation lines are created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs. After the end of the procedure the implantable loop recorder is implanted in the parasternal area of the chest.; The procedure of AF ablation is the same like in the circumferential PV isolation.
After AF ablation procedure, the angiogram of both renal arteries is performed via femoral access. After that the treatment catheter is introduced into each renal artery and is applied discrete, radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. After the procedure the control arterial angiogram should be done.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arterial hypertension; Atrial Fibrillation; Percutaneous renal denervation
Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 3

Summary: 
      Benfotiamine pretreatment (3 days)at high dosage (1050 mg/day) prevents in healthy subjects
      smoking-induced vascular dysfunction assessed by ultrasound flow mediated dilatation of the
      brachial artery.
    

Detailed description: 
      Benfotiamine pretreatment (3 days)at high dosage (1050 mg/day) prevents in healthy subjects
      smoking-induced vascular dysfunction assessed by ultrasound flow mediated dilatation (FMD) of
      the brachial arteryand laboratory parameters (adhesion molecules).
    

Intervention name(s): Benfotiamine
Intervention type(s): Drug
Intervention MeSH terms: Benphothiamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Prevention
Randomized, Double-blind, Placebo Controlled Phase II Study to Examine the Effects of DAS181 in Healthy Adult Subjects With Laboratory Confirmed Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This protocol will seek to enroll adult otherwise healthy subjects presenting with
      influenza-like illness (ILI). Subjects will enter the study based on listed
      inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV).
    

Detailed description: 
      This protocol will seek to enroll adult otherwise healthy subjects presenting with
      influenza-like illness (ILI). Subjects will enter the study based on listed
      inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV).

      Based upon a Rapid Diagnostic Test of IFV, subjects will be randomized into one of three
      groups: a single dose DAS181 10 mg group, a multiple dose DAS181 10 mg, 10 mg, 10 mg dose
      group or a placebo group.

      The full analysis set will include subjects with confirmed influenza as documented with Rapid
      Diagnostic Testing. The set will be used for activity analysis and will include all
      randomized subjects with baseline and treatment data. Study staff may visit subjects outside
      the clinic. Per protocol, the safety analysis sets are described below in Statistical
      Methods.

      Peripheral venous blood samples for pharmacokinetic (PK) and immunogenic analysis of DAS181
      will be obtained on 10 subjects enrolled in each study arm.
    

Intervention name(s): DAS181 dry powder, formulation F02; Respitose ML006 (DMV-Fonterra)
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg delivered dose DAS181 in clear HPMC #3 Capsules; Lactose monohydrate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exercise and Type 2 Diabetes: Gender and Endothelial Function
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The objective of the current proposal is to evaluate the importance of blood vessel
      dysfunction and heart dysfunction to overall exercise impairments in type 2 diabetes and
      their contribution to the gender differences observed in exercise capacity. Importantly,
      treatments that improve blood vessel function in persons with type 2 diabetes can be used to
      directly assess whether impairment in blood vessel function and ultimately exercise
      performance, can be improved and whether the degree of improvement differs between the sexes.

      Hypothesis 1. Uncomplicated type 2 diabetes more adversely affects exercise capacity in women
      than men.

      Hypothesis 2. Blood vessel function and cardiac function are more significantly impaired in
      women with type 2 diabetes than men and contribute to the gender differences in exercise
      capacity.

      Hypothesis 3. Restoration of blood vessel function will improve exercise capacity more in
      women than men with type 2 diabetes.
    

Detailed description: 
      Subjects will come in for a total of seven research visits. Four initial study visits before
      exercise training for three months and then subjects will repeat the testing.

        1. Initial exam. A history and physical exam will be performed. Blood will be drawn for
           measurements of overall health. Resting electrocardiogram will be obtained. The Low
           Level Physical Activity Recall (LOPAR) questionnaire will be administered.

        2. Dual Energy X-ray Absorptiometry (DEXA) will be carried out during visit two. A
           familiarization bicycle ergometer test will also be performed on this day.

        3. During visit three, a euglycemic clamp will be performed.

        4. During visit four, echocardiographic measurements will be made and a diet interview will
           be performed.

        5. On visit five, measures of blood vessel-dependent vasodilation will be performed.
           Repeated brachial artery diameter and forearm blood flow responses to cuff occlusion
           will be measured separately on this occasion.

        6. On visit six, arterial stiffness will be measured. Subjects will also perform a graded
           bicycle exercise test.

        7. On visit seven, subjects will perform constant level bicycle tests.
    

Intervention name(s): Supervised Exercise Training
Intervention type(s): Other
Intervention description(s): All subjects will perform three months of supervised exercise training.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: diabetes; exercise; heart; cardiovascular
Standing Balance Control Across the Lifespan
Condition: Children, Adult
Study type: Interventional

Summary: 
      Falls are the leading cause of nonfatal injuries in children and elderly. To understand the
      causes of falling in these populations, fundamental knowledge of how ageing affects balance
      control is of utmost importance.

      In general, two biomechanical mechanisms allow people to control balance; 1.moving the center
      of pressure within the base of support using ankle muscle activation; 2.counter-rotating
      segments around the center of mass. To understand how balance is controlled differently
      across the lifespan, 4 age groups (each N=20) will be compared to each other; i.e.
      prepubertal children (6-9y), postpubertal children (15-17y), young adults (18-24y), healthy
      non-falling older adults (65-80y). .

      A force plate platform combined with 3D movement registration will be used to determine the
      biomechanical balance control strategy across the lifespan during unperturbed and perturbed
      standing. The innovative but focused scope of this study could provide a breakthrough in our
      biomechanical understanding of balance control and, in particular, the changes in limitations
      of balance control in childhood and an ageing (fall-prone) population. The gained fundamental
      knowledge could lead to unprecedented insights in the causes of falling across the lifespan
      and in possible targets for intervention.
    


Intervention name(s): Balance boards
Intervention type(s): Device
Intervention description(s): The unstable surface will be created with a balance board consisting of a wooden board mounted on a section of a cylinder, creating an unstable support in the sagittal plane or in the frontal plane. The participants will stand on three balance boards, varying the height of the surface of the board above the point of contact (15, 17 and 19 cm respectively). The radius of the cylinder will kept constant at 24 cm. The standing surface will be 48cm x 48 cm
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of a Therapeutic Exercise Program for Injuries Prevention in Wheelchair Basketball (WB) Players
Condition: Athletic Injuries; Shoulder Pain; Shoulder Injury
MeSH terms: Shoulder Pain; Wounds and Injuries; Shoulder Injuries; Athletic Injuries
Study type: Interventional

Summary: 
      Shoulder pain is the most common symptom of physical dysfunction in wheelchair basketball
      players. About the 85% of this population had shoulder pain in some moment of their life.
      Some studies suggest that exercise is an important tool as an element to treat and prevent
      shoulder injuries. For that reason, an intervention program would be a useful tool for
      prevent shoulder injuries in this population.

      The purpose of this study is determine the effects of therapeutic exercise program wheelchair
      basketball players, in order to prevent shoulder injuries.
    

Detailed description: 
      The hypothesis of the study was that the exercise program was effective to prevent shoulder
      injuries in this population.
    

Intervention name(s): Exercise group
Intervention type(s): Behavioral
Intervention description(s): This group will receive a home exercise program of shoulder based on mobility, strength and strengthening exercises, lasting 10 weeks, 3 times per weeks. The target dose use for mobility consisted in 8 repetitions for each 4 movements, for strengthening using resistive bands, 3 sets (including 5 exercises) of 10 repetitions with a 45 second rest between sets and 5 repetitions for each 5 strength with a 30 second rest and general protocol of postural hygiene. The instructional of the program is 30 minutes each day during the time of the study (10 weeks) with a screening about the exercise program and the daily activities performed every 4 weeks. Physiotherapist provided support to subjects through email along 10 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise Therapy; Shoulder pain; Shoulder injuries; Shoulder function; Prevention; Wheelchair users
Impact of Cocoa Flavanols on Pulmonary Oxygen Uptake Kinetics and Exercise Tolerance in Sedentary Middle-aged Adults
Condition: Aging; Sedentary Behavior
Study type: Interventional

Summary: 
      In recent years, there has been significant interest in dietary flavonoids (biologically
      active plant-derived compounds) as potential therapeutics. This is due to the capacity of
      flavonoids to enhance processes related to energy metabolism and cardiovascular health. We
      are interested in implementing a short-term supplementation regime (daily cocoa-flavanoid
      ingestion), in order to explore the possible beneficial effects of flavonoid-based
      interventions on responses to exercise. Hence, the objective of our study is to examine the
      impact of short term cocoa-flavanoid supplementation on processes related to energy use
      (oxygen utilisation). Our aim is to develop a novel intervention which improves
      cardiovascular health and enhances exercise tolerance.
    


Intervention name(s): Cocoa flavanols; Placebo supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Flavonoid-rich cocoa powder, containing 100mg total flavanols per 316mg.; Microcrystalline filler, containing 0mg total flavanols.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Reduction in the Risk of Rejection by Mycophenolate Mofetil Dose Adjustment in Liver Transplant Patients With Side Effects Caused by the Calcineurine Inhibitors
Condition: Liver Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this project is to determine whether, in liver transplant patients with side
      effects due to ICN, the use of MMF in monotherapy can be optimised by dose adjustment based
      on the area under the curve (AUC) of mycophenolic acid (MPA). It involves a multicentre phase
      IV trial with direct individual benefit.

      A population of 130 liver transplant patients at 2 to 10 years post-transplant, showing
      significant clinical ICN side effects and being given bitherapy by ICN +MMF will be included
      and randomised 1:1 in two arms:

        -  Arm 1: progressive interruption of ICN after obtaining an AUC of MPA of 50 mg.h/l,
           followed by MMF monotherapy with dose adjustment based on the AUC of MPA,

        -  Arm 2: continuation of the ICN+MMF bitherapy without MMF therapeutic drug monitoring.

      The main judgement criterion will be the incidence of acute rejection in the 2 groups at 6
      months. The secondary judgment criterion will be the evaluation of the benefit of stopping
      ICN on the side effects caused by these drugs.
    


Intervention name(s): Mycophénolate Mofétil; Ciclosporine A; Tacrolimus
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Mycophenolic Acid; Cyclosporine; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Topical rhThrombin as an Adjunct to Hemostasis During Segmental Hepatectomy
Condition: Hepatectomy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      rhThrombin is a serine protease from human.The study is to assess the Safety, Tolerability,
      Immunogenicity and efficacy of rhThrombin.
    

Detailed description: 
      The study is a randomized, single-blind,blank controlled phase 1&2 trial ,including 3
      independent parts toevaluate the safety,efficacy and immunogenicity.

      The first part is ascending dose,blank control tolerability and safety study. The Starting
      doses from 500IU/ml to 1000IU/mL and 2000IU/mL to evaluate the safety,efficacy.

      The second part is randomized, single-blind, blank controlled study to evaluate
      safety、efficacy and immunogenicity. Doses settings :1000IU/mL , 2000IU/mL and blank group
      which with absorbable collagen sponge when used.

      The third part is randomized, single-blind, blank controlled study to evaluate
      safety、efficacy and immunogenicity. Doses settings :1000IU/mL , 2000IU/mL and blank group
      which directly sprayed on hemorrhagic point when used.
    

Intervention name(s): rhThrombin ( Topical ); placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Substance; saline solution
Other intervention name(s): Recombinant Human Thrombin (CHO Cell) for Topical Use; PLA
Intervention MeSH terms: Thrombin
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The first part is ascending dose study: 3 subjects take rhThromb and 1 subjects take the same volume of saline; The second part is dose extension study:2 cohorts and 1 blank control group( the same volume of saline) used with absorbable collagen sponge;every group need 12 subject; The second part is dose extension study: 2 cohorts and 1 blank control group( the same volume of saline);every group need 12 subject;
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Serine protease; Tolerance; Immunogenicity; Safety
Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      Macular edema is the main cause of low vision in diabetics. They continue looking for new
      treatment alternatives. The nutritional supplement Alzer, is a powerful antioxidant that
      together with Diamel, a supplement that has shown efficacy in metabolic control, could be a
      therapeutic option. Objective: To evaluate the therapeutic efficacy of the Alzer Diamel
      combination in mild and moderate macular edema. Material and method: A randomized
      double-blind phase II clinical trial versus placebo will be conducted in 64 patients, who
      will be randomly assigned to two groups, one will receive Alzer + Diamel and another will
      receive placebo from Alzer and Diamel. All patients will undergo clinical, biochemical and
      ophthalmological evaluation during the study.
    


Intervention name(s): Oral treatment Alzer y Diamel; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Alzer:
Administration way: Oral Dosage: one 500 mg tablet 3 times a day (1500 mg daily) Frequency: after breakfast, lunch and dinner. Duration: one year.
Diamel:
Administration way: Oral Dosage: two 660mg capsules 3 times a day (3960 mg daily) Frequency: before breakfast, lunch and dinner. Duration: one year.; Placebo treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Nutritional supplement; Diabetic Macular Edema; Diabetes; Alzer; Oxidative Stress; Diamel
Computer Guided Esthetic Crown Lengthening
Condition: Altered Passive Eruption of Teeth; Guided Surgery; Gummy Smile
MeSH terms: Exanthema
Study type: Interventional

Summary: 
      The objective of the present study was to evaluate the effectiveness of surgical esthetic
      crown lengthening using digitally assisted 3D printed surgical stents in management of
      excessive gingival display due to altered passive eruption.
    

Detailed description: 
      The objective of the present study was to evaluate the effectiveness of surgical esthetic
      crown lengthening using digitally assisted 3D printed surgical stents in management of
      excessive gingival display due to altered passive eruption.

      Primary objectives:

      Wound healing Score: the clinical features of periodontal wound healing were measured
      according to Hagenaars et al using the following parameters: swelling of the soft tissue ,
      color of the gingiva, probing pocket depth, bleeding index, plaque index, clinical attachment
      level. These signs were assessed at 1 week, 3 months and 6 months post-operative.

      Operating time: the time needed to complete each procedure was calculated in minutes by using
      a stopwatch from the time of the first incision till the completion of bone removal.

      Secondary objectives:

      Patient satisfaction: was assessed using visual analogue scale at 24 hours, 7 days and 14
      days post operatively. (Zero is for minimum pain and ten is for maximum pain).

      Gingival margin stability: The position of gingival margin in relation to a reference point
      was evaluated immediately after surgery, 3 months and 6 months healing period .
    

Intervention name(s): Conventional Esthetic crown lengthening; Computer guided Esthetic crown lengthening
Intervention type(s): Procedure; Procedure
Intervention description(s): Conventional Surgical Esthetic Crown Lengthening; Computer guided Esthetic crown lengthening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment