cyrilzakka/clinical-trials huggingface dataset:
Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease

The primary objective of the study is to determine if subthalamic nucleus (STN) deep brain stimulation (DBS) using the Vercise directional leads improves neuropsychiatric state and neuropsychiatric fluctuations 12 months after surgery in a large consecutive series of STN-DBS Parkinson's disease (PD) patients.

This project of further use of health-related data with consent by the participants is a prospective, international project to evaluate the improvement of neuropsychiatric symptoms and the quality of life 12 months after surgery in a large consecutive series of STN-DBS PD patients using novel implantable Neurostimulator Systems (Boston Scientific). The project will investigate if a fine tuning of the STN-DBS settings could alleviate neuropsychiatric fluctuations, apathy as well as DBS-induced dysarthria and global motor state. The tuning is performed in agreement with the instruction for use of all devices used. Further objectives are validation of new tools that are presently entering clinical routine in optimizing postoperative management like individual current sources, steering, imaging of volume of tissue activated, and beta-oscillations.

The data originates from patients suffering from levodopa-responsive PD which are not adequately controlled by dopaminergic medication and therefore receive STN-DBS as a routine standard of care with routinely collected data.

In total 110 patients who are candidates for STN-DBS will be enrolled in four participating sites in Switzerland and the EU.

Eligibility Criteria:
Inclusion Criteria:

For all subjects:

* Informed consent as documented by signature
* Diagnosis of PD based on the MDS clinical diagnostic criteria for Parkinson's disease
* Fulfilling criteria for STN-DBS:
* The presence of disabling motor complications of dopaminergic treatment
* The absence of surgical contraindications
* Planned bilateral STN-DBS using steering electrodes in the next 3 months (routine standard of care)

Exclusion Criteria:

* Presence of dementia as indicated by a score ≤ 25 on the MOntreal Cognitive Assessment (MOCA)
* Depression with acute suicidal ideation
* Presence of major ongoing psychiatric illness
* Non-compensated systemic disease (i.e., diabetes, hypertension)
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Participation in interventional trial within the 30 days preceding and during the present study
* Previous enrolment into the current study
* Enrolment of any study site personnel, their family members, employees or other dependent persons
A Study of Breath Testing for Small Intestinal Bacterial Overgrowth

Researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors.


Eligibility Criteria:
Inclusion criteria:

* Predominant symptoms of gastroesophageal reflux disease including heartburn, regurgitation
* Subjects must be able to give appropriate informed consent

Exclusion criteria:

* Prior diagnosis of SIBO
* Use of PPIs or H2R-anatagonstists in the prior 3 months
* Major concomitant illness (renal, hepatic, rheumatologic or cardiovascular disease, or malignancy)
* Antibiotic therapy within one month
* Prior gastrointestinal surgery including esophageal, gastric, and small or large bowel surgery
* Previously diagnosed irritable bowel syndrome or inflammatory bowel disease
* Individuals who are pregnant or breast feeding
* Patients with plans to become pregnant
* Inability to take PPIs, including allergy/sensitivity
Daily Home Spirometry for Early Detection of Pulmonary Complications in Patients With COVID19

The aim of this preliminary study is to describe the potential decline in forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by home spirometry in high-risk subjects infected with COVID-19. We hypothesize that the magnitude of such a decline in FEV1 and/or FVC may be associated with clinical deterioration and hospitalization. The study will ultimately inform a larger subsequent RCT that will evaluate the efficacy of home spirometry in the early detection (pre respiratory symptoms) of respiratory complications and therefore prompt early medical attention which is a key for improving outcome.


Eligibility Criteria:
Inclusion Criteria:

1. without dyspnea and with no evidence of pneumonia, ARDS, organ failure or requiring admission to ICU.
2. All patients ≥55 years age or ≥1 risk factor for disease complications (prior pulmonary, kidney or cardiovascular disease, diabetes mellitus, hypertension, bone merrow suppression, solid organ transplant, HIV with CD4\<250, heavy smoker, BMI \>30). All participants will sign a written informed consent.

Exclusion Criteria:

1. Patients unable to perform spirometry
2. contraindications for spirometry (hemoptysis, active tuberculosis, syncope associated with forced exhalation or increased risk for spirometry)
3. adhere to the follow-up protocol.
The Effect of Lateral Tilt on Ventilation Distribution in Lungs Assessed by Electrical Impedance Tomography

Prevention of lung inhomogeneity is an essential part of preventive strategy in neurocritical care, reducing the risks of secondary brain damage from hypoxemia, hypo/hypercapnia or pneumonia.

In the monocentric, intervention, prospective, randomized study, the investigators will examine the effect of lateral tilting (routinely used in critical care) on the lung inhomogeneity that will be analyzed by electrical impedance tomography (EIT) in the unconscious patients with acute primary brain disease and artificial pulmonary ventilation. Two types of lateral tilting will be compared: manual positioning of body by nurse versus the bed tilting (15° lateral tilt, original company (LINET) and product brand name (Eleganza 5).

Eligibility Criteria:
Inclusion Criteria:

* Primary brain disease
* Hospitalization in Neurocenter, Neurointensive Care Unit
* Age\>18 years
* Unconsciousness
* Artificial pulmonary ventilation

Exclusion Criteria:

* Intracranial hypertension
* History of primary lung disease
* The terminal stage of the disease
* Refractory hemodynamic instability
Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses

The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted wearers of one of the listed contact lenses
* Subjects must be myopic
* Subjects must use a lens care system on a regular basis.

Exclusion Criteria:

* Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months.
* Subjects with any systemic disease affecting ocular health.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or are using any ocular medication.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects who have had any corneal surgery (eg, refractive surgery).
* Subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures

Comparing the rate of complications between buried and exposed intramedullary implants after fixation of pediatric forearm fractures.

comparison between buried and exposed intramedullary k-wire in fixation of pediatric forearm fracture in rate of complications such as infection,malunion,nonunion and refracture.

Eligibility Criteria:
Inclusion Criteria:

1. Age: less than 10 years .
2. Diaphyseal forearm fracture.
3. closed fracture.
4. isolated or combined fracture of forearm.

Exclusion Criteria:

1. Patient age: more than 10 years old . 2-open fracture. 3- pathological fracture. 4-patient with medical history (immune compromized patient e.g D.M, cancer on chemotherapy and aplastic anemia).

5- neurovascular injury.
Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction

We will study in a prospective randomised fashion 50 patients who will be treated by intracoronary transplantation of autologous, mononuclear bone marrow cells (BMCs) in addition to standard therapy after MI or standard therapy.

After standard therapy for acute MI, 10 patients were transplanted with autologous mononuclear BMCs via a balloon catheter placed into the infarct-related artery during balloon dilatation (percutaneous transluminal coronary angioplasty). Another 10 patients with acute MI were treated by standard therapy alone. After

Experimental and clinical data suggest that bone marrow-derived cells may contribute to the healing of myocardial infarction (MI).

Eligibility Criteria:
Inclusion Criteria:

* Recent acute transmural anterior myocardial infarction, (in agreement with WHO)
* single left anterior descending coronary artery disease
* \<72 hour from the origin of symptoms
* successful primary angioplasty of the culprit lesion

Exclusion Criteria:

* screening \>72 hours after infarction,
* cardiac shock, severe comorbidity, alcohol or drug dependency
* severe comorbidity (DM,renal or liver insufficiency)
* potential child bearing woman
* inability to provide informed consent
Auricular Point Acupressure to Manage Pain in Patients With Alzheimer's Disease and Related Disorders

Pain is considered as one of the most important causal factors of behavioral and psychological symptoms in patients Alzheimer's disease and related disorders (ADRD). The investigators plan to examine the effectiveness of pain relief, pain sensory change and immune biomarkers change (measured by serum biomarkers) after the auricular point acupressure (APA). A waitlist will be used to examine the feasibility of a 4-week APA intervention. The investigators will also explore potential analgesic pathways and underpinnings of APA on pain relief.

A waitlist pilot study will be conducted to examine the feasibility of a 4-week APA intervention. Participants and their caregivers will be enrolled into the study. Following the baseline assessment (1st home visit), participants will wait one month and will be randomized to an interventionist or caregiver-training group.

Both groups will have a home/office visit at pre-intervention, followed by three home visits weekly, and a final home/office visit at post-intervention. Participants in both groups will have 1 monthly follow-up phone call after the completion of APA.

Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of possible or probable ADRD by National Institute of Aging (NIA) and Alzheimer's Association Guidelines,
* have a caregiver who is able to help and manage APA,
* pain that has persisted at least 3 months and pain on at least half of the days for the previous 6 months,
* average intensity of pain ≥ 4 on a 10 point numerical pain scale in the past 7 days,
* receiving care at the Johns Hopkins Memory and Alzheimer's Treatment Center (JHMATC), Johns Hopkins Alzheimer's disease Research Center (JHADRC),
* willing to commit to 5-weekly study visits (first office visits and followed by home visits) by the study coordinators and two follow-up home visits (at three- and six-months follow-up),
* have any type of dementia, mild to moderate stages (Montreal Cognitive Assessment, MoCA, ≥ 8),
* caregiver is willing to participate.

Exclusion Criteria:

* concurrent major psychiatric disorder (e.g. major depressive disorder (as primary diagnosis), bipolar disorder, schizophrenia) or drug and alcohol abuse,
* severe illness or pain that would lead to significant deterioration in health, or that would limit participation in the interventions (e.g. metastatic cancer, musculoskeletal disorders, etc.)
Pain After Lung Cancer Surgery - Comparing Traditional Versus Prolonged Release Nerve Blockades

To investigate the effect of liposomal bupivacaine compared with bupivacaine hydrochloride for intercostal blockades for patients undergoing Video-assisted thoracoscopic surgery.

Video-assisted thoracoscopic surgery (VATS) is a minimally invasive routine procedure. It's less invasive than thoracotomy but postoperative pain is still a problem.

At Aalborg University Hospital, intercostal blockades with bupivacaine is used as standard pain treatment for patients undergoing VATS. Adding adjuvants to the blockades may prolong the effect.

The aim of this study is to examine if intercostal nerve blockades with liposomal bupivacaine improves postoperative pain management compared to intercostal nerve blockades with bupivacaine hydrochloride.

Eligibility Criteria:
Inclusion Criteria:

* Adults independent of sex with an age of ≥ 18 years
* Patients undergoing VATS as a part of either examination or treatment of lung cancer

Exclusion Criteria:

* Patients who are unable to understand oral and written information.
* Patients with known chronic pain in the thorax which have been persisting for at least six months before the day of surgery.
* Pregnant and nursing women.
* Patients with hypersensitivity / allergy / Intolerance to dexamethasone or bupivacaine.
* Patients receiving a planned preoperative epidural blockade during their stay.
* Patients converted to open surgery.
Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

This study evaluate the addition of Vit E to clomiphene citrate in the treatment of poly cystic ovary.Half the patients will receive both Vit E and clomiphene citrate the other half will receive clomiphene citrate only.

Clomiphene and vit E each used in treatment of pco but they do so by different mechanisms.

Clomifene is in the selective estrogen receptor modulator (SERM) family of medication. It works by causing the release of gonadotropin-releasing hormone by the hypothalamus, and subsequently gonadotropin from the anterior pituitary.

Vit E is used in treatment of pco due its anti-oxidant effect.

Eligibility Criteria:
Inclusion Criteria:

1. Patients will be diagnosed as having PCOS according to the Rotterdam criteria for diagnosis of PCOS
2. Age between 18 and 39 years.
3. Period of infertility \>1 years.
4. No treatment taken during the last 2 months.
5. Patients who have previously received clomiphene citrate (CC) and being diagnosed as having CC resistance

Exclusion Criteria:

1. History of pelvic surgery or infertility factor other than anovulation
2. Endocrine disorders in the form of hypothyroidism or hyperthyroidism, hyperprolactinemia, and Cushing syndrome, as detected by history, examination, or investigations.
3. Known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin K deficiency.
4. Consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date.
5. Male factor infertility (sperm count \< 5 million per milliliter, normal morphology \<4%).
6. Elevated serum prolactin, T.S.H and F.S.H.
7. Patients diagnosed with diabetes mellitus
Vitrectomy Combined With Intravitreal Dexamethasone Implant for Idiopathic Epiretinal Membrane With Macular Oedema

The goal of this clinical trial is to evaluate the efficacy and safety of 25-gauge pars plana vitrectomy combined with intravitreal dexamethasone implant for the treatment of idiopathic epiretinal membrane with cystoid macular oedema. The main questions it aims to answer are:

* mean changes in best corrected visual acuity and central macular thickness from baseline to post-operative 24 weeks
* mean change in proportion of cystoid macular oedema area from baseline to post-operative 24 weeks
* intraocular pressure throughout postoperative 24 weeks
* concentrations of inflammatory factors in vitreous samples Participants will undergo a standard three-port 25-gauge pars plana vitrectomy and epiretinal membrane peeling combined with phacoemulsification, aspiration, and intraocular lens implantation. The dexamethasone implant will be injected into the vitreous cavity at the end of the operation.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic patients aged 40 years or above with idiopathic stage 3-4 epiretinal membrane defined on the basis of spectral-domain optical coherence tomography classification;
* central retinal thickness \>300 µm;
* cystoid oedema within a 1 mm diameter range with the macular fovea as the center;
* ocular axial length less than 25.00 mm.

Exclusion Criteria:

* concomitant or previous macular diseases that may hinder visual improvement other than epiretinal membrane (e.g., age-associated macular degeneration, retinal vein occlusion, or diabetic macular oedema);
* previous vitreoretinal surgery or intravitreal injection history;
* history of glaucoma or optic neuropathy of any kind;
* patients with uncontrolled systemic diseases or infectious diseases;
* patients who took medicines that may have ocular side effects, such as glucocorticoid or hydroxychloroquine.
Effect of Kinetic Chain Exercises on Muscle Strength, Joint Position Sense and Quality of Life in Children with Haemophilia.

The goal of this clinical trial is to learn if there are effect of close kinetic chain exercises on muscle strength, joint position sense and Quality of life in children with haemophilia? Null hypothesis

It will be hypothesized that:

There is no effect of close kinetic chain exercises on muscle strength, joint position sense and Quality of life in children with haemophilia.

Sample size estimation will be carried out to determine the recruited number of children selected randomly from Out Patient clinic of Atfal Misr hospital, Cairo governorate to participate in this study. The study targets male children with hemophilia A.

They will be selected based on the following:

Inclusion criteria:

1. Their chronological age will be 5-7yeasr.
2. All children will receive prophylaxis therapy.
3. They will able to stand and walk independently.
4. They will be able to follow instructions during evaluation and treatment.

Exclusive criteria:

The children will be excluded if they have one of the following:

1. Visual or auditory problem.
2. Radiographic changes as bone erosions, destruction, or joint subluxation, or congenital or acquired skeletal deformities in both lower limbs.
3. Surgical procedures performed six weeks prior to or during study.
4. Bleeding in joint 2 week prior to assessment.

Eligibility Criteria:
Inclusion Criteria:

* 1. Their chronological age will be 5-7yeasr. 2. All children will receive prophylaxis therapy. 3. They will able to stand and walk independently. 4. They will be able to follow instructions during evaluation and treatment.

Exclusion Criteria:

* The children will be excluded if they have one of the following:

  1. Visual or auditory problem.
  2. Radiographic changes as bone erosions, destruction, or joint subluxation, or congenital or acquired skeletal deformities in both lower limbs.
  3. Surgical procedures performed six weeks prior to or during study.
  4. Bleeding in joint 2 week prior to assessment.
Open-Label, Extension Study to 810P202

Open-label, extension study for subjects that completed 810P202 to examine long term safety and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

1. Successful completion of the 810P202 study.
2. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
3. Weight of at least 20kg.
4. Able and willing to swallow tablets whole and not chewed, cut or crushed.
5. Written informed consent/assent obtained from the subject's parent or legally-authorized representative (LAR), and written informed assent obtained from the subject if required.

Exclusion Criteria:

1. Body Mass Index (BMI) in 97th percentile or above.
2. Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
3. Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential).
4. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or complying with the study procedures.
Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease

We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD.

This study aims to enroll 40 patients with mild and moderate Alzheimer's disease with apathy symptoms that will be randomized to receive rTMS or sham procedure. Subjects will be randomized in two arms (rTMS or sham procedure) in 1:1 proportion.

Eligibility criteria:

* Diagnosis of Alzheimer's disease, mild and moderate stage (MMSE range from 10 to 20);
* Diagnosis of apathy;
* age between 60 and 85 years-old;
* On stable doses of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine for at least 6 months prior to enrollment;

The primary outcome measures is the Apathy Inventoire. Secondary outcome measures are the NPI score, ADAS-cog scores and the Zarit Burden Scale scores.

Eligibility Criteria:
Inclusion Criteria:

* Age between 60 to 85 years-old
* Mild or moderate Alzheimer's disease (MMSE scores between 10 and 20)
* Apathy diagnosis
* On stable doses of cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and/or memantine for at least 6 months prior to enrollment

Exclusion Criteria:

* history of epilepsy or convulsions
* History of migraine or headaches episodes twice per week or more
* History of neurodegenerative diseases other than Alzheimer's disease
* Current use of first generation antipsychotics, clozapine, tricyclic drugs or anticonvulsants
* History of cerebral ischemic episode
Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study

APEX-FIH is a first-in-human, open-label prospective multicenter study of the TrelliX Embolic Coil System for use in embolization of the medium to large, ruptured or unruptured cerebral aneurysms


Eligibility Criteria:
Inclusion Criteria:

* Subject age ≥18 and ≤80 years with a diagnosis of a ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure
* Aneurysm size \[largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen) ≥5 mm and ≤16mm
* If ruptured aneurysm: either WFNS grade 1 or 2, or Hunt and Hess 1 or 2
* If unruptured aneurysm: Subject grade Modified Rankin Scale mRS 0 - 2
* Investigator plans to use ≥70% in volume TrelliX coils to fill target aneurysm

Exclusion Criteria:

* Prior treatment (surgical or endovascular) of the target aneurysm
* Planned treatment of multiple aneurysms in index procedure
* Planned use of other modified coils (Matrix, HydroCoil or fibered coils)
* Planned use of liquid embolic material
* Life expectancy less than 12 months
* Presence of arteriovenous malformation
* Fusiform, mycotic, traumatic, or tumoral aneurysms
* Intended or planned aneurysm treatment by parent vessel occlusion
* Clipping or endovascular treatment of another intracranial aneurysm performed within 30 days before or planned within 30 days following the index procedure