cyrilzakka/clinical-trials huggingface dataset:
Deep Brain Stimulation and Parkinson's Disease

* Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective treatment for a large variety of movement disorders. However, the efficacy of STN-DBS relies on unclear mechanisms.
* Purpose: In this study, using optical imaging, the investigators will evaluate the cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor task and delay discounting task. the investigators will perform an optical imaging study using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS. The investigators will measure bilateral local cortical hemodynamic changes under "On" and "Off" stimulation conditions and during a motor task (left hand movement) and delay discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will be continuously analyze.
* Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) under " on " and " off " stimulation during a motor task.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting Parkinson disease and treated by STN-DBS.
* For comparison patients: Patients treated by DBS in other target.

Exclusion Criteria:

* Patients who cannot be treated by DBS
Effectiveness and Safety of Zilucoplan Treatment for French Patients with Myasthenia Gravis Over 3 Months

This study called "Multicenter Retrospective Study on the Short- and Medium-Term Efficacy and Tolerance of Zilucoplan Therapy in a Cohort of French Patients with Anti-AChR Myasthenia Gravis", is investigating the effects of a new treatment called Zilucoplan (generic name: ZILBRYSQ) on patients in France with a condition known as myasthenia gravis. Myasthenia gravis is an autoimmune disease that causes muscle weakness that worsens throughout the day with activity and impacts the ability to work and perform daily activities. The study aims to see if Zilucoplan can improve muscle strength and quality of life over three months, while also assessing its tolerance and safety by monitoring side effects. Researchers hope this treatment will offer significant benefits for people with this challenging condition.


Eligibility Criteria:
Inclusion Criteria:

- Confirmed diagnosis of myasthenia gravis with anti-AChR antibodies in patients treated with Zilucoplan

Exclusion Criteria:

* None
Develop and Validate a Self-Administered Instrument That Will Screen for Eating Disorder Symptoms in Persons Aged 12 and Older With Type 1 Diabetes.

The purpose of this study is to develop and validate a survey instrument to be used by persons with type 1 diabetes aged 12 and older to screen for an eating disorder.

Phase 1 - Develop an initial instrument and start to establish content validity. What do dually diagnosed patients believe are the most important, relevant, and significantly contributing constructs that we should measure in order to capture those individuals with type 1 diabetes who may exhibit symptoms of an eating disorder? What individual items will best measure these constructs?

Phase 2 - Conduct individual interviews for cognitive testing of our instrument and further examine its content validity. How well do the individual items included in our instrument capture eating disorder symptoms in patients with type 1 diabetes? Do these items accurately capture the information we seek to collect? What symptoms have we not considered? How readable and understandable are our questions?

Phase 3 - Explore the internal consistency reliability and construct validity of our instrument. Do the items in our instrument accurately capture the constructs we wish to measure? Do similar items "hang together" in a manner that is clinically and theoretically meaningful?

Phase 4 - Address convergent and discriminant validity as well as test-retest reliability. Does our instrument demonstrate appropriate convergent and divergent validity as well as test-retest reliability? Does our instrument capture eating disorder symptoms among persons with diabetes? Is our instrument more specific to the population of individuals with diabetes than traditional eating disorder instruments (i.e., does our instrument capture more information and give a more accurate presentation than the other instruments)?

Eligibility Criteria:
Inclusion Criteria:

* eating disorder
* type 1 diabetes

Exclusion Criteria:

* none
Immediate Effects of Superficial Heat Associated With Elongation in the Posttraumatic Elbow Contracture

The elbow contracture is a secondary injury that can occur after direct trauma, causing the patient to have limitations in their range of motion. Objective evaluation protocols that help in decision making for the indication of these therapeutic resources have great value in rehabilitation, as they reduce unnecessary expenses and improve the assertiveness in the indication of this resource.

Objective: To verify the immediate effects of superficial heat associated with sustained stretching through muscle activity and range of motion in the posttraumatic contractures of the elbow seeking the best indication of orthosis.

Methods: Characterized as a randomized crossover type clinical trial. Sample of 20 adult subjects, of both sexes, over 18 years old, with elbow stiffness due to fractures and / or dislocations with indication of orthosis use. Patients will be divided into 2 randomly assigned intervention groups: the control group (CG) who will perform the 10 'sustained stretching drawn by a defined load through maximal voluntary isometric contraction (MVIC) and the modified Weeks Group (GWM) will perform 20 'of surface heat through the swirl and soon after the stretching sustained by 10' with already defined load. All patients will undergo an initial assessment and will participate in all 2 interventions while respecting a 7 day washout period. Goniometry and the visual analogue scale will be applied at the beginning and end of the interventions. The Delsys® brand equipment will be used to collect the electromyographic data. Placement and positioning of the electrodes will follow the determinations of the Seniam protocol. The activation of the brachial, brachioradial and triceps brachii muscles during the MVIC will be analyzed and also during the respective intervention protocols.


Eligibility Criteria:
Inclusion:

* patients between the ages of 18 and 60
* of both sexes
* who present elbow stiffness with flexural contractures resulting from fractures and / or dislocations,
* who are in the stages of fibroblastic healing and remodeling
* will be selected, with indication of use of bracing for gain of range of motion
* whether or not undergoing rehabilitation either after conservative or surgical orthopedic treatment

Exclusion:

* Individuals who have clinical or surgical restrictions to perform activities of daily living
* therapeutic exercises or use of orthoses
* who have lesions in the central nervous system
* open lesions
* moderate to high intensity pain to sustained passive stretching
Far Infrared Radiation Treatment for Uterine Fibroids

A preliminary study to determine the efficacy of using energy specific far infrared (FIR) radiation for the treatment of uterine fibroids.

Uterine fibroids are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape and often highly vascular. On MR imaging exams, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid.

We are postulating that energy specific electromagnetic radiation of the uterus will shrink the benign tumors.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18 or older with symptomatic fibroids

Exclusion Criteria:

* Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment
* Metallic implants that are incompatible with MRI or ultrasound
* Known intolerance to the MRI contrast agent (e.g. Gadolinium)
ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study

Patients with macular hole \<400µm will be randomized for ILM flap Transposition and ILM Peeling for surgical repair of macular holes

Patients with macular hole with a diameter larger than 400µm have better sucess with ILM flap transposition, but there are no data published examining the outcome of macular hole with a diameter \<400µm. Therefore, patients with macular hole with a diameter \<400µm will be randomized for ILM flap transposition and ILM peeling for surgical repair of macular holes

Eligibility Criteria:
Inclusion Criteria:

* macular hole with a diameter \<400µm

Exclusion Criteria:

* Prior ILM peeling
Comparative Effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in Patients With Chronic Low Back Pain

•Null hypothesis: There is no difference in effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain.

•Alternative hypothesis: There is difference in effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain.

The purpose of the study is to compare the effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain on Pain, Range of Motion, Quality of Life and Functional Disability.

The study procedure will be explained to the patients and informed written consent will be obtained from those patients who will be willing to participate in the study. Quadratus Lumborum tightness will be assessed using side bending test.

Those fulfilling the requirement of inclusion criteria will be indiscriminately separated into 2 groups. NPRS, Oswestry Disability Index, SF-20 and goniometer will be used to collect data.

Total 68 participants will be recruited in the study. Routine Physical therapy will be provided to group A. Reciprocal inhibition Muscle Energy Technique on quadratus lumborum along with Routine Physical Therapy will be performed on group B.

Both group will receive interventions three sessions in a week for 4 consecutive weeks.

Assessment of Pain, Range of motion, Quality of Life and Functional Disability will be assessed by using goniometer, NPRS, Oswestry Disability Index and SF-20 Questionnaire respectively for both groups at the baseline, end of 6th session (2nd week) and end of 12th session (4th week) and follow up will be obtained after 1 month (8th week).

Eligibility Criteria:
Inclusion Criteria:

* Both genders of age 30 to 55 year.
* Patients with pain for at least three months or more (chronic stage).
* Patients having score of at least 3 on 0-10 points(NPRS).
* Diagnosed patients of low back pain.
* Non-radicular low back pain.
* Quadratus Lumborum tightness by physical test i.e. side bending test.

Exclusion Criteria:

* Pregnant females.
* Lumbar radiculopathy.
* Any spinal pathology i.e. infectious disease and fracture.
* Any congenital deformity of spine, upper and lower extremities.
* Systemic illnesses i.e. cardiovascular disorders, respiratory disorders etc.
* History of surgery of hip, pelvis, lumbar spine, disc herniation.
Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level

This study is designed in order to investigate the effect of cinacalcet in combination with routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT) and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Peritoneal dialysis patients with secondary HPT(iPTH \> 300 pg/mL)
* \> 18 yr of age, \< 70
* had receive PD for \> 3 mo,
* intact PTH level \> 300 pg/ml and \<1000 pg/ml
* albumin corrected Ca level \>= 9.0 mg/dL

Exclusion Criteria:

* pregnant or breast-feeding,
* had undergone parathyroidectomy within previous 3 mo,
* are involved in other clinical trial within 30 d
* had received cinacalcet therapy previously.
Comparative Effectiveness in the Management of Irreversible Pulpitis

This project addresses a central question within the practice of dentistry: Is a pulpotomy procedure effective in the treatment of a tooth with symptomatic irreversible pulpitis and normal periapex? In addition, the project seeks to identify clinical and molecular biomarkers that are predictive of the success of pulpotomy.

In this study, patients will be randomized to two groups. All patients will have a diagnosis of irreversible pulpitis with normal apical tissues. The groups will be root canal treatment and pulpotomy. The patients will be followed clinically and radiographically for 2 years following the treatment. Predictors of the outcome of pulpotomy will be clinical and laboratory-based parameters.

Eligibility Criteria:
Inclusion Criteria:

* Maxillary or mandibular first or second mature permanent molars with carious lesions or restorations (excluding crowns), with signs and symptoms of symptomatic irreversible pulpitis (defined as spontaneous pulpal pain and cold hyperalgesia \>30 seconds), and normal apical tissues.
* Tooth is responsive to cold and electrical pulp testing.
* Patients aged ≥12 years for first molars and ≥16 years for second molars.

Exclusion Criteria:

* Evidence of Pulp Necrosis or Apical Periodontitis, preoperatively or upon inspection of an exposure site
* Teeth that are badly broken down and/or are not restorable.
* Teeth with mechanical allodynia assessed by registering bite force that is at least 50N lower than the contralateral side.
* Teeth with radiographic evidence of internal, or external cervical, inflammatory or replacement root resorption, or with complete pulp canal obliteration.
* Radiographic evidence of PDL space wider than three times normal width
* Clinical evidence of swelling or sinus tract
* Periodontal pocket probing depth ≥5 mm in any site around the tooth.
* Clinical evidence of cracks connecting mesial and distal surfaces and/or extending in pulp chamber or associated with periodontal pockets ≥ 5 mm.
* History of taking centrally acting drugs (e.g., tricyclic antidepressants), which interfere with the release of pain mediators and/or modify pain experience, within the previous 6 months.
* Use of medications that affect the host response such as methotrexate, corticosteroids or cyclosporin.
* Patients on immunosuppressive agents, chronic corticosteroid use, autoimmune disease, or other immunocompromising diseases or medications.
* Patients who require IV sedation or general anesthesia for their dental treatment.
* Teeth with full coverage crowns.
* Teeth undergoing active orthodontic movement.
* Teeth that require elective RCTx to place a post for restorative purposes.
* Teeth with no contralateral molars with normal pulp and periapical tissues for bite and pulp testing controls.
* Teeth in the pulpotomy group in which, following complete pulpotomy, bleeding does not stop after 10 minutes with 3-4% hypochlorite cotton pellet. These will be considered treatment failure and treated with RCTx.
Neonatal Brain Ultrasound With CEUS and Elastography

The aim of our study is to investigate changes of brain perfusion and elasticity in neonates during the time that a neonate is adapting to live outside the womb and during diseases that are suspected to affect neonatal brain perfusion. We use contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography to evaluate the state of brain perfusion. We will study neonates recruited from the Neonatal Units of Turku University Hospital.

SonoVue (sulphur hexafluoride) is a contrast agent composed of micro bubbles. It increases echogenicity of the ultrasound thus enhancing the visualisation of vessels and giving better insights into tissue perfusion. The use of sulphur hexafluoride has been approved by FDA and it has been in off-label use in Europe for years. SonoVue is thought to be especially useful for children, because it can enhance the diagnostic capabilities of ultrasound and the examination can be performed without radiation or sedation.

Elastography is a method to investigate the elasticity of a tissue by tracking the shear waves generated by the ultrasound beam. Also this method has been used in Europe and America for years.

The aim of our study is to examine cerebral hemodynamics in neonates using ultrasound of the brain, contrast enhanced ultrasound (CEUS) and ultrasound-guided shear-wave elastography (US-SWE). We aim to recruit four groups of infants: those with no suspected diseases affecting brain perfusion on the first days after birth and infants with either asphyctic injury, stroke or other diseases affecting central nervous system. Total recruitment for different groups is 100 infants in total, during this first study phase. The recruitment period will be up to seven years if needed.

The injections of SonoVue will be administered through pre-existing venous cannulas. The first examination after brain injury will be done as soon as the parental consent has been given. The ultrasound examination altogether is estimated to take about 20 minutes per day. Safety monitoring period is conducted after the injection. The studies will be repeated 0-4 times according to the approval of the caretakers of the child and the disease the child is affected by. CEUS data will be analysed with proper software. US-SWE will be measured repeatedly on both brain hemispheres and on different areas to validate the measurements.

Eligibility Criteria:
Inclusion Criteria:

* Babies less than 7 months treated at the neonatal units of Turku University hospital

Exclusion Criteria:

* Pre-known genetic disease
* Difficult congenital malformations that need surgical treatment
* Central nervous system tumors
* Weight less than 2,5 kg during examination
* Medical history of SonoVue hypersensitivity
* Uncontrolled systemic hypertension
* Systolic pulmonary artery pressure \> 90 mmHg
* Unstable cardiovascular state
Simethicone and N-acetylcysteine in Upper Endoscopy - Prospective Double-blinded Randomized Controlled Trial

The upper endoscopy is one of the most common methods for the diagnosis and treatment of upper gastrointestinal (GI) tract diseases and provides a unique opportunity to identify early neoplastic lesions.

Before an upper endoscopy it is required a 6 hour fasting period\[1\]. However, even with this fasting period, sometimes the mucosal visualization, especially in the stomach, is impaired by the presence of foam, bubbles or gastric mucus.

To improve visualization of the gastric mucosa, it is possible to administrate an oral solution of defoaming agents such as Simethicone and mucolytic agents like Pronase or N-Acetylcysteine previously to the procedure.

The aim of this project is to determine if the use of premedication with simethicone, alone or in association with N-Acetylcysteine, improves mucosal visualization during an upper GI endoscopy.

a. Study type: prospective, randomized, double-blinded, placebo-controlled trial: i. Prospective inclusion of patients; ii. Randomization by computer generated tables; iii. Allocation concealment by sealed, opaque envelopes; iv. Double-blinded - nurse instructed not to reveal treatment; patient and doctor unaware of treatment;

b. Patient selection: consecutive series of patients scheduled for upper gastrointestinal endoscopy; Exclusion criteria - sedation, previous total gastrectomy, known neoplasia or stenosis, allergies to simethicone or N-acetylcysteine, therapeutic or urgent procedures;

c. Sample size: 270 (3 groups of 90 patients): to improve "excellent" preparations from 20% (value from our own database) to 40% and assuming a normal distribution and a power of 80% (α=0.05), the calculated sample size of each of the 3 groups was 82; allowing for a 10% dropout rate, the sample size is 90 (270 patients overall); Groups: Group A - 100mL of water (placebo); Group B - 100mL of water plus 100mg Simethicone; Group C - 100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine;

d. Data collection methods: form sheet filled by nurses (appendix 1) and endoscopist (appendix 2);

e. Analysed variables: patients characteristics (age, gender), indication for endoscopy, time from administration to procedure, score of mucosal visualization, side effects of medication;

f. Statistical analysis: chi-square test.

Eligibility Criteria:
Inclusion Criteria:

* consecutive series of patients scheduled for upper gastrointestinal endoscopy
* signed informed consent

Exclusion Criteria:

* sedation
* previous total gastrectomy
* known neoplasia or stenosis
* therapeutic or urgent procedures
* allergies to simethicone or N-acetylcysteine
Effects of Different Exercise Training Programs in CKD 4-5

The investigators' purpose is to study which exercise training modality: aerobic physical activity in conjunction with either resistance training or balance training, is most beneficial in patients with chronic kidney disease (CKD 4-5: GFR \< 30 ml/min/1.73mUP\[2\]). Furthermore, our purpose is to evaluate the long-term effects of exercise training on functional status, cardiovascular morbidity, blood pressure control, heart rate variability, cardiac function, inflammation, body composition, nutritional status, progression of uraemia and health related quality of life. This interventional study is prospective, randomized and controlled comprising 150 prevalent and incident patients from our outpatient clinic. Patients are invited to participate in the study consecutively, irrespective of basic functional status. At start patients are randomised either to resistance or balance training and the programme is adapted and individualised to each patient's actual physical status and ability. The exercise prescription is to exercise for 30 minutes/day, 5 days/week, keeping the intensity constant at a level of "somewhat strenuous" to "strenuous" on the Borg scale rate of perceived exertion. The total observation period is 12 months with checks every four months. Although exercise training is a recommended therapy in CKD, there is a lack of medical and scientific evidence on optimal prescription. We hope that this study will provide evidence-based knowledge on exercise prescription and its effects on various risk factors in CKD patients. Finally, if patients achieve a higher degree of physical functional capacity they should be able to maintain an autonomous lifestyle, resulting in considerable reductions in societal costs for care and transportation.


Eligibility Criteria:
Inclusion Criteria:

* CKD 4 and 5
* over 18 years of age
* no neurological or orthopedic impairments
* stable cardiac status

Exclusion Criteria:

* not on renal replacement therapy
* no severe electrolyte disturbances