bioihbjkbjnl/mcl2 huggingface dataset:
Aerobic vs Core Stability Exercise Training Program in Women With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      To compare the effects of aerobic and core stability exercise training program on pain, sleep
      and quality of life in women with endometriosis.
    


Intervention name(s): aerobic exercises; core stability exercises
Intervention type(s): Other; Other
Intervention description(s): This group will be received aerobic exercises 3 sessions per week for 8 weeks. Warm up phase: in which each participant will walk at 80 m/min at 0.0% grade for 5 mint.
Active phase: treadmill speed will be increased to 147 m/min and grade will be increased gradually untill reached 25% grade for 20 mint.
Cool down phase: in which the treadmil speed and grade will be decreased to 2.0miles/h and 0.0% grade during a cool down period consisted of 5 mint.; This group will be received core stability exercises 3 sessions per week for 8 weeks.
All participants in both groups will be evaluated before and after the treatment programs.
Lie on your back and place your feet on a wall so that your knees and hips are bent at 90 degrees angles. Tighten your abdominal muscles.
Raise your head and shoulders off the floor. Return to the start position and repeat.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: endometriosis; Aerobic exercises,; core stability,; Quality of life
Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus
      sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated
      Individuals
    


Intervention name(s): vibrating capsule; sham non-vibrating capsule
Intervention type(s): Device; Device
Intervention description(s): patients will receive vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].; patients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: constipation
Processing of Salient Emotional Stimuli as a Function of Tetrahydrocannabinol (THC) and Cannabidiol (CBD)
Condition: Healthy Humans
Study type: Interventional

Summary: 
      Attentional blink refers to a phenomenon where the detection of the second of two target
      stimuli that are presented in Short succession within a stream of stimuli is impaired. This
      is explained by an insufficient availability of attentional resources. Additionally,
      emotionally salient stimuli, like for example pictures with a positive or negative content,
      are detected more often compared to neutral pictures during this attentional blink period.

      Cannabinoids are involved in the modulation of cognitive, attentional, and emotional
      processes. Interestingly, data from animals suggests that THC and CBD, both active
      ingredients in the Cannabis sativa plant, have opposing effects on brain cannabinoid (CB1)
      receptors. CB1 receptors modulate the expression of emotionally salient conditioned
      association in rats, if salience processes in humans are modulated in the same way remains
      unclear.

      Employing a task to detect salient stimuli, Bhattacharyya et al. (2012) showed that THC seems
      to make non-salient standard stimuli more salient. They showed decreased activation of the
      right caudate and increased right prefrontal cortex stimuli during processing of salient
      stimuli. Importantly, this was associated with decreased response times to standard relative
      to oddball stimuli. Generally, THC and CBD differentially modulate brain areas associated
      with attentional salience processing. For example THC seems to increase prefrontal and
      striatal activation whereas CBD seems to decrease it.

      The investigators assume that THC increases the number of correctly detected emotional
      stimuli during the attentional blink period, whereas CBD has no effect. Additionally, the
      investigators assume that pictures of the positive category are detected with higher accuracy
      than negative ones under the influence of THC.
    


Intervention name(s): tetrahydrocannabinol; cannabidiol; placebo
Intervention type(s): Drug; Drug; Other
Intervention MeSH terms: Dronabinol; Cannabidiol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: THC and CBD; Attentional blink
Family MobilePhone Otoscopy in Diagnostics of Otitis Media
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional

Summary: 
      This is a one-center clinical study carried out in Turku, Finland. The study patients will be
      randomly allocated to one of the two parallel study groups (teaching group and control
      group). The hypothesis is that the diagnostic quality of tympanic membrane imagines is better
      when parents have been taught to conduct middle ear examination with a cellphone otoscope
      (CellScopeOTO) as compared to no teaching. Furthermore, this study aims at evaluating the
      diagnostic feasibility of cellphone otoscopy.
    


Intervention name(s): Teaching; (CellScopeOTO)
Intervention type(s): Other; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: otoscopy; otitis media; cellphone; family
Comparison of the Effects of Ordinary and Differential Learning Based Physiotherapy on Subjects With Ischemic Stroke Torso Control, Balance and Gait in the Second Phase of Rehabilitation
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      The purpose of this study was to assess the effect or ordinary and differential learning
      based physiotherapy for torso control, balance and gait on subjects with ischemic stroke in
      the second phase of rehabilitation
    

Detailed description: 
      Ischemic stroke is still the second most common cause of death and one of the leading causes
      of disability worldwide. Half of all individuals with ischemic stroke do not regain lost body
      functions until the end of life. Individuals with ischemic stroke are most likely to have
      impaired cognitive, sensory, and motor functions, but the greatest challenge for health care
      professionals is impaired motor skills caused by motor nerve cell damage. In order to
      minimize the degree of disability, it is important to respond quickly to a person's
      condition. Because it has been shown that lost functions can be taken over by adjacent,
      non-stroke-affected areas of the cerebral cortex, early rehabilitation is a key factor that
      can help prevent function limitation by acting in conjunction with spontaneous recovery of
      body function.

      The aim of the study is to assess the effect or ordinary and differential learning based
      physiotherapy for torso control, balance and gait on subjects with ischemic stroke in the
      second phase of rehabilitation.

      The study was approved by Committee on Biomedical Research Ethics of Kaunas Region
      (2020-06-30 No.BEC-KN(B)-263).
    

Intervention name(s): Intervention group; Control group
Intervention type(s): Other; Other
Intervention description(s): Differential learning based physiotherapy to improve torso control, balance and gait; Ordinary physiotherapy program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety Study of Three Formulations of the Dermal Implant ELAPR
Condition: Skin Conditions
MeSH terms: Skin Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study to assess the safety of three formulations of the dermal implant
      ELAPR.
    

Detailed description: 
      A Phase I study to assess the safety of three formulations of the dermal implant ELAPR in
      healthy subjects.
    

Intervention name(s): ELAPR; ELAPR
Intervention type(s): Device; Device
Intervention description(s): ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.; Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003
Other intervention name(s): Other Names:; Tropoelastin 0.1ml SC implant; Tropoelastin 0.1ml SC implant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: skin
A Safety Study of NNZ-2566 in Patients With Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the
      treatment of Rett Syndrome in adolescent and adult females.
    

Detailed description: 
      Rett Syndrome is a developmental disorder primarily if not exclusively affecting females. The
      disorder is characterized by apparent normal development in early infancy (6-18 months),
      followed by a period of regression with onset of systemic and neurological signs. The CNS
      symptoms of Rett Syndrome include learning disability, autism and epilepsy and these can be
      severe and highly debilitating. Affected individuals also show signs of autonomic
      dysfunction, reflected in cardiovascular and respiratory abnormalities. There is no currently
      effective treatment for Rett Syndrome.

      This study will investigate the safety and tolerability of treatment with oral administration
      of NNZ-2566 at 35 mg/kg or 70 mg/kg BID in adolescent or adult females with Rett Syndrome.
      The study also will also investigate measures of efficacy during treatment.
    

Intervention name(s): NNZ-2566; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with strawberry flavored solution 0.5% v/v in Water for Injection.; Strawberry flavored solution and Water for Injection
Other intervention name(s): Strawberry flavored solution 0.5% v/v in Water for Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Rett's Syndrome; Rett Disorder; Rett's Disorder; Ataxia
Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias
Condition: Sleep Apnea; Ventricular Arrythmias; Systolic Left Ventricle Dysfunction
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Arrhythmias, Cardiac; Systolic Murmurs
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis:

      The CPAP treatment diminishes the effect of ventricular arrhythmias in patients with ischemic
      heart disease or dilated myocardiopathy, systolic ventricular disfunction and sleep
      apnea-hypopnea syndrome (SAHS)Objectives: To analyze the incidence of ventricular arrhythmias
      (premature ventricular beat, non-sustained ventricular tachycardia and sustained ventricular
      tachycardia) and appropriate defibrillator therapies in patients with ischemic heart disease
      or dilated myocardiopathy, moderate-severe left ventricular dysfunction,with an implantable
      cardioverter-defibrillator (ICD) and sleep apnea. To study the effect of CPAP on the cardiac
      arrhythmias and on the number of appropriate defibrillator therapies.

      Design:

      Parallel, randomized and single-blinded multicentric study to compare CPAP vs.
      hygienic-dietetic recommendations.

      Patients with SAHS (AHI≥15) and systolic left ventricle dysfunction patients with an ICD.

      Duration: 24 months.
    

Detailed description: 
      Secondary objectives:

      To compare the prevalence of SAHS in patients with ischemic heart disease or dilated
      myocardiopathy and moderate-severe left ventricle dysfunction with ICD with that of the
      general population. To study the incidence of supraventricular arrhythmias (atrial
      fibrillation, atrial flutter or supraventricular tachycardia) and inappropriate defibrillator
      therapies in these patients. To value the effect of the treatment with CPAP on the above
      mentioned arrhythmias. To relate the effect of ventricular and supraventricular arrhythmias
      with sleep parameters, cardiovascular biomarkers, inflammation and oxidative stress. To
      evaluate the long-term effect of the CPAP on systemic biomarkers in patients with ischemic
      heart disease or dilated myocardiopathy and moderate-severe left ventricle dysfunction. To
      evaluate the long-term effect of CPAP on the quality of life in these patients.

      Sample size:

      224 patients with ischemic heart disease or dilated myocardiopathy and moderate-severe left
      ventricle dysfunction with ICD will be included to randomize 19 SAHS subjects for arm.
    

Intervention name(s): Nasal continuous positive airway pressure
Intervention type(s): Device
Intervention description(s): Nocturnal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Sleep apnea; CPAP; Ventricular arrhythmias; Defibrillator therapies
Patient Compliance to Self-collection for Detection of HPV-DNA
Condition: Compliance; Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      A study to investigate the compliance of unassisted women to self-collection of specimens for
      Hybrid Capture (HC) for detection of Human Papilloma Virus (HPV) DNA compared to Pap smear
      collection by medical personnel, as screening method to identify precursor lesions of
      cervical cancer.
    

Detailed description: 
      Women living in the community of the Morro dos Macacos, Vila Isabel, Rio de Janeiro, were
      randomly allocated for self-collection of specimens for HC II for detection of HPV-DNA or to
      Pap smear collection by medical personnel, as screening method to identify precursor lesions
      of cervical cancer.

      The compliance was measured by the delivery of the specimen obtained by self-collection or to
      attend to a visit at the community health center to be submitted to Pap smear collection,
      within a week.
    

Intervention name(s): Self-collection; Gynecologist collection
Intervention type(s): Procedure; Procedure
Intervention description(s): Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for HCII.; Women allocated to this arm will be asked to attend to medical office to have their Pap smear obtained by a gynecologist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Patient Compliance; HPV-DNA probes; Papanicolaou test; Cervical cancer
Pain Perception is Attenuated in Patients With Painless Myocardial Infarction
Condition: Myocardial Infarction; Myocardial Ischemia
MeSH terms: Myocardial Infarction; Myocardial Ischemia; Coronary Artery Disease; Infarction; Ischemia
Study type: Observational

Summary: 
      To explore whether reduced systemic pain perception in response to painful stimuli and
      personality pain related variables characterizes silent MI patients.
    

Detailed description: 
      Objective: Silent myocardial infarction (MI) is an event of severe myocardial ischemia
      without pain experience. The lack of pain alarm leads to increased morbidity and mortality,
      because the patients do not sick timely medical treatment. This study aims to explore whether
      reduced systemic pain perception in response to painful stimuli and personality pain related
      variables characterizes silent MI patients.

      Methods: Level of chest pain intensity was assessed by visual analogue scale (VAS), range
      from 0 (no pain) to 100 (maximal pain). Heat pain threshold, magnitude estimation of
      supra-threshold painful stimuli at 47ºC as well as pain catastrophizing scores were assessed
      in 90 acute MI patients (mean age 66±12.1, range 33-79) with chest pain (n=65) and without
      pain symptoms(n=25). All stimuli were performed by Thermal Sensory Analysis (TSA) and applied
      to the right forearm.

      Results: The demographic variables, history of ischemic heart, risk factors for coronary
      artery disease, ST-T segment changes on ECG and troponin levels were similar in both groups.
      Greater intensity of chest pain VAS scores was inversely correlated with lower pain threshold
      (r= -0.417, p<0.001), and directly associated with higher pain scores in response to the heat
      pain (r=0.354, p=0.002). Patients with painful MI demonstrated lower pain threshold (41.9±3.6
      vs. 44.9±3.8, p=0.001), higher VAS scores in response to the supra-threshold painful stimuli
      (50.2 ±21.8 vs. 27.0±25.2, p=0.002), and higher catastrophizing level (10.6±12.0 vs. 5.4±8.8,
      p=0.032). Chest pain complaint was not related to ST-T changes as well as concomitant
      diseases.

      Conclusions: This study suggests that reduced systemic pain perception as well as cognitive
      personality variables play an important role in the etiology of Silent MI.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: Therma,pain, Silent myocardial ischemia, catastrophizing
Evaluation of a Diabetes Treatment and Education Program for Insulin Pump Therapy (INPUT)
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study is a randomized, controlled, prospective trial with a 6-month follow-up. A newly
      developed treatment and education programme for diabetic patients with an insulin pump
      therapy (INPUT) will be tested compared to a waiting group. Primary outcome variable is the
      difference in glycemic control between baseline and the 6-month follow-up. Secondary outcome
      variables are: severe hypoglycaemia, diabetes-related distress, depressive symptoms,
      health-related quality of life, diabetes empowerment, self-care behavior, hypoglycemia
      awareness, and attitudes towards insulin pump therapy.
    

Detailed description: 
      INPUT is a self-management-based treatment and education program for diabetic patients with
      an insulin pump (CSII). It is designed to empower patients to adequately perform their
      therapy in daily life and to integrate their diabetes and their insulin pump into their lifes
      in order to enhance quality of life.

      INPUT ist tested in an randomized controlled trial (RCT) with a waiting-list control group
      since no certified and effective treatment and education program for CSII exists.

      This study is a multi-center study. Study centers are specialized diabetes practices
      throughout Germany. Patients will be approached by their respective practice and informed
      about the study. Study measurements as well as the conduct of INPUT will take place at the
      respective practice.

      Baseline measurement will take place 2 weeks prior to the beginning of INPUT. After
      completion of baseline measurement, all patients from one study center will be randomized
      centrally by the Research Institute of the Diabetes Academy Mergentheim (FIDAM). 2 weeks and
      6 months after the completion of INPUT, follow-up measurements will be conducted at the
      respective study center.

      HbA1c as a marker of glycemic control will be analyzed in a central laboratory. Secondary
      outcome measures will be assessed via psychometrically tested questionnaires, Case Reports
      Forms, or patient files.
    

Intervention name(s): INPUT
Intervention type(s): Behavioral
Intervention description(s): Treatment and education program based on the self-management theory of behavioral medicine.
The program is delivered by certified and specially trained diabetes educators.
Other intervention name(s): treatment and education program for INsulin PUmp Therapy
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: self-management; empowerment; treatment and education program; insulin pump; diabetes education
Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Patients With Slight Hypertension and Target Organ Damage
Condition: Hypertension; Ventricular Remodeling; Erectile Dysfunctions
MeSH terms: Erectile Dysfunction; Hypertension; Ventricular Remodeling
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with slight increase in blood pressure levels have an increased cardiovascular risk.
      In particular this has been demonstrated also in subjects with high-normal blood pressure in
      whom an exaggerated blood pressure increase, during exercise, and structural left ventricular
      abnormalities have been shown. On the other hand, the last American and European guidelines
      for management of hypertension recommend more aggressive treatment in young-middle aged
      subjects to achieve a better control of cardiovascular risk due to blood pressure increase.
      In agreement with these recommendations the investigators share the idea that a good blood
      pressure control should be achieved not only at rest, but also during psycho-physical stress
      conditions that frequently occur during daily life. On this basis, the investigators decided
      to evaluate the efficacy and tolerability of the association of valsartan and
      hydrochlorothiazide (160 an 25 mg daily, respectively) in patients with high-normal blood
      pressure and first degree arterial hypertension with evidence of organ damage.

      The aim of this study is to assess if an early and adequate therapy could bring to a better
      pressure control (even during physical activity) and a regression of organ damage without
      interfering with metabolism and erectile function
    


Intervention name(s): Valsartan 160mg plus HCT 25mg
Intervention type(s): Drug
Intervention description(s): valsartan 160 mg once a day for 6 months plus hydrochlorothiazide 25 mg a tablet once a day for 6 months
Other intervention name(s): Corixil 160/25mg; Cotareg 160/25mg
Intervention MeSH terms: Valsartan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to Establish Safety, Tolerability, and Efficacy of PresbiDrops (CSF-1) in Presbyopic
      Subjects.
    


Intervention name(s): PresbiDrops (CSF-1); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PresbiDrops (CSF-1) is a topical ophthalmic drug.; Placebo drops contain the same ingredients as PresbiDrops except for the active ingredients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment