cyrilzakka/clinical-trials huggingface dataset:
Observational Study to Observe Variations of Gait Parameters in Patients with Neuromuscular Diseases

This study has the general objective of observing walking parameters during a clinical test to objectively estimate fatigue in patients with neuromuscular diseases. Furthermore, the investigators want to evaluate the feasibility of collecting physical activity in daily life conditions during a one-week monitoring period using a wearable sensor.


Eligibility Criteria:
Inclusion Criteria:

* Ambulant adult patients with genetic diagnosis of muscular dystrophy/myopathy (dystrophinopathies, muscular dystrophies and congenital and non-congenital myopathies), of spinal muscular atrophy (SMA) and with molecular diagnosis of Charcot-Marie Tooth 1 or 2.
* independent walking, even with assistance;

Exclusion Criteria:

* Dilated or ischemic heart disease with moderate impairment;
* Chronic respiratory failure: forced vital capacity (FVC) \< 40%; more than 5% of nocturnal time spent with peripheral oxygen saturation levels \< 90.
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease

The study is looking at the role of the mesentery in disease recurrence for ileocolic Crohn's disease. It is a prospective study that has been designed to perform extended mesenteric excision on patients undergoing their first ileocolic resection for Crohn's disease. Endoscopic recurrence will be monitored with the hypothesis that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection.

(limited mesenteric resection).

The current standard of care for ileocolic Crohn's disease (CD) is a limited mesenteric resection. There is growing, but still limited, evidence that extended mesenteric excision during ileocolic resection is beneficial in decreasing disease recurrence. We propose a prospective multicenter cohort study to better understand the role of extended mesenteric excision in ileocolic CD and how it affects disease recurrence. The primary outcome of this study will be the rate of endoscopic recurrence at 6 months in patients undergoing first-time resection for ileocolic CD. Secondary outcomes will include endoscopic recurrence at 18 months and rates of recurrence requiring surgery by 2 years. These outcomes will be compared to historical controls (limited mesenteric resection). Our hypothesis is that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection. As seen in previous studies, advanced mesenteric and mucosal disease predicts increased surgical recurrence.

Eligibility Criteria:
Inclusion Criteria:

adults \>18 years old diagnosis of CD limited to the distal ileum/ileocolic region no previous ileocolic resection all forms of CD presentation will be included - stricturing, fistulizing, perforating etc.

Exclusion Criteria:

previous ileocolic resection other sites of CD intraabdominal sepsis
A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS

This is a randomized double-blinded controlled study comparing aerosolized pentamidine with trimethoprim plus sulfamethoxazole (TMP / PurposeX). The latter drug will be administered intravenously for at least 5 days, then changed to oral administration if warranted by the patient's clinical condition.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed.

Pneumocystis carinii pneumonia (PCP) in an adult who is HIV positive by ELISA, HIV culture, or p24 antigenemia, or is a member of a risk group for HIV infection (homosexual or bisexual men, intravenous drug abusers, recipients of HIV infected blood products, and the sexual partners of the foregoing groups).

* The patient must have a resting Alveolar - arterial oxygen (A-a) DO2 less than 30 mmHg on room air at all ACTG sites, except San Francisco General Hospital. Other sites will enter patients up to a resting (A-a) DO2 = or \< 55 mmHg on room air.

Prior Medication:

Allowed:

* Zidovudine as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Dyspnea.
* Cough.
* Bronchospasm.
* History of a major adverse reaction to pentamidine or sulfonamide containing preparations.

Patients with the following will be excluded:

* Inability to cooperate with aerosol administration because of dyspnea, cough, bronchospasm, or other reasons.
* History of a major adverse reaction to pentamidine or sulfonamide containing preparations.
* In the opinion of the investigator, the patient would not complete therapy or follow-up for social reasons.

Prior Medication:

Excluded within 14 days of study entry:

* Systemic steroids above adrenal replacement doses.
* Excluded within 6 weeks of study entry:
* Other antiprotozoal regimen for this episode such as trimethoprim / sulfamethoxazole (TMP / PurposeX).
* Pyrimethamine.
* Fansidar.
* Pentamidine.
* Eflornithine (DFMO).
* Dapsone, whether therapeutic or prophylactic, or any of these agents.
Preoperative Nutritional Status Scores to Predict PPC in Elderly With Cardiac Surgery

This prospective study investigate prognostic values and compare the role of nutritional status by using GNRI, MNA, and PNI in predicting post-operative pulmonary complication among elderly patients with cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patient age ≥ 60 years
* Open heart surgical procedure on pump (CABG, valvular disease, combine CABG and valve surgery
* Elective surgery

Exclusion Criteria:

- Emergency surgery
Helical CT, PET/CT, MRI, and CBCT Alone or in Combination in Predicting Jaw Invasion in Patients With Oral Cancer

This clinical trial studies how well helical computed tomography (CT), positron emission tomography (PET)/CT, magnetic resonance imaging (MRI), and cone beam computed tomography (CBCT) work alone or in combination in predicting whether tumor cells have spread to the jaw bone (jaw invasion) in patients with oral cancer. Imaging, such as helical CT, PET/CT, MRI, and CBCT, may help find out how far cancer has spread. Accurate prediction of the presence or absence of jaw invasion may help create a better surgical treatment plan for patients with oral cancer.

PRIMARY OBJECTIVES:

I. To determine which imaging modality or combination of imaging methods, in conjunction with clinical and histological examination, will most accurately predict the presence or absence of invasion of the mandible or maxilla by intraoral squamous cell carcinoma (SCC).

SECONDARY OBJECTIVES:

I. To compare the histopathologic findings to the radiologic findings.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of squamous cell carcinoma of the oral cavity
* Able to read and sign and informed consent

Exclusion Criteria:

* Prior mandibular surgery
* Primary intraosseous carcinoma
* Prior history of radiation to the mandible
* Obvious finding of clinical invasion of the mandible
Reducing Cesarean Childbirth Rates Using the Hem-Avert Perianal Stabilizer

This study is being conducted to evaluate an FDA approved device called the HEM-AVERT® Perianal Stabilizer and the efficacy in reducing the C-section rate and/or reducing the second stage of labor times.

Women may sometimes be reluctant to push resulting in a prolonged second stage labor, which could lead to a Cesarean section. This study will record the frequency of Cesarean sections in two groups to determine if there are any measurable differences.

The investigational device in this study is the HEM-AVERT® Perianal Stabilizer manufactured by Stetrix, Inc. This device has received previous FDA clearance as a Class II device to prevent hemorrhoids during childbirth. This study is being conducted by Stetrix, Inc. and falls within the guidelines set forth by the Food and Drug Administration in 21 CFR Section 812.2 as a non-significant risk study. The HEM-AVERT® Perianal Stabilizer is a Class II device in accordance with FDA regulation 21 CFR 890.5765. The Class II version of the device and the investigational device are identical in terms of materials, design, intended population and area used. The sole difference is that data will be collected in order to support an application to the FDA to obtain clearance of the device for the specific claim of reducing the C-section rate and/or reducing the second stage of labor times. This difference in data collection may be viewed as off-label use of the device although there is no new risk to the subject in the use of this device as an investigational device.

The primary objective of this study is to reduce the C-section rate and/or the second stage of labor times while using this device. For patients scheduled for a vaginal delivery, success is defined as completing the vaginal delivery process.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women between the ages of 18 and 40 years old at the time of enrollment
2. Gestational age between 34 and 42 weeks at the time of enrollment
3. Live singleton gestation
4. Candidate for vaginal delivery.
5. Willing and able to comply with the study plan as indicated by understanding and signing the subject informed consent form

Exclusion Criteria:

1. Subject unable to speak English
2. Subject unable to understand and sign the informed consent form
3. Delivery planned outside the clinical center
4. Subject is scheduled for vaginal delivery with anticipated complications (i.e. including but not limited to non-vertex presentation or macrosomia \>4,000 grams)
5. Subject scheduled for an elective cesarean birth
6. Preeclampsia with severe features, eclampsia, HELLP syndrome
7. Multiple Gestation
8. PROM (premature rupture of membranes)
9. Previous Cesarean Section
10. PTL (preterm labor)
11. Known major fetal anomaly or fetal demise.
12. Suspected or proven chorioamnionitis
13. Placenta previa
14. Maternal insulin dependent diabetes
15. Maternal health conditions deemed as risk factors by investigators such as renal or cardiopulmonary disease
Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon

Juvenile primary Raynaud's (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. When children with primary Raynaud's Phenomenon are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. Children with primary Raynaud's Phenomenon have no underlying systemic disease. The cause for their symptoms is unknown. The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. It has been used in a variety of other conditions in which blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of primary Raynaud's episodes in juvenile patients.


Eligibility Criteria:
Inclusion critera:

* 5 to 6 years old
* fulfill diagnostic criteria for primary or secondary Raynaud's
Clinical, Molecular and Metabolic Characteristics of Parkinson's Disease (PD) Patients With Parkin Mutation

Parkinson's disease is a frequent neurodegenerative disorder. Genetic forms of the disease have been recently identified. The monogenic form due to parkin mutation is responsible for many familial cases and sporadic forms. However, the relationship between the mutation and the genotype of patients is not fully established. The aim of this study is to compare clinical, metabolic and neuropsychological characteristics obtained in patients with parkin mutation with those of patients without parkin mutation.


Eligibility Criteria:
Inclusion Criteria:

* Juvenile Parkinson's disease (\< 45 years)
* Parkin mutation
* Normal brain magnetic resonance imaging (MRI)

Exclusion Criteria:

* Contraindication to brain MRI
* Women without effective contraception
Management of Pericarditis in Children.

The pericardium is a double-walled sac containing the heart and the roots of the great vessels. The pericardial sac has two layers, a serous visceral l layer (also known as epicardium when it comes into contact with the myocardium) and a fibrous parietal layer. It encloses the pericardial cavity, which contains pericardial fluid. The pericardium fixes the heart to the mediastinum, gives protection against infection and provides lubrication for the heart. Pericardial diseases may be either isolated disease or part of a systemic disease Diseases of the pericardium present clinically in one of several ways

* Acute and recurrent pericarditis
* Pericardial effusion without major hemodynamic compromise
* Cardiac tamponade with cardiac compromise
* Constrictive pericarditis

* Pericarditis usually present with chest pain and dyspnea. Effusion can present with no symptoms, dull ache in left chest and abdominal pain Cardiac tamponade is recognized by the excessive fall of systolic blood pressure
* Diagnostic workup A) Chest X-ray:_ chest X-ray can detect varying degree of cardiomegaly. B) Echocardiography: It is the first-line imaging test. clinically, two-dimensional echocardiography with Doppler provides the most cost-effective way of diagnosing C) Electrocardiograph D) cardiac computerized tomography :- Also may be helpful 4)Therapy of pericarditis in pediatrics the medical lines of treatment of pericarditis are:_ A)Aspirin and non-steroidal anti-inflammatory:_ are the mainstay of the therapy of inflammatory pericardial diseases B)Steroids: a minority of patients will require treatment with systemic steroid therapy as

  * Patients with symptoms refractory to standard therapy

    * Acute pericarditis due to connective tissue disease ●Uremic pericarditis C)Immunosuppressant and biological drugs (more commonly used in recurrent pericarditis) .Interventional therapeutic techniques-_

Most patients with acute pericarditis can be managed effectively with medical therapy alone. However, patients may require invasive therapies for:

* A moderate to large pericardial effusion, particularly if hemodynamically significant.
* Frequent, highly symptomatic recurrences of acute pericarditis with pericardial effusion ●Evidence of constrictive pericarditis (a late occurrence when present) A)Pericardial drainage :Prolonged catheter drainage of a pericardial effusion is an effective means of preventing fluid reaccumulation.

B)Pericardiotomy, pericardial window and pericardiectomy: pericardiectomy may be considered for frequent and highly symptomatic recurrences of pericarditis tamponade .. C)Surgical decompression of the pericardium :_can be achieved either by conventional heart surgery or video-assisted thoracoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Children with pericarditis and/or pericardial effusion above one year of age detected clinically and by echocardiography

Exclusion Criteria:

* children below one year of age. - children with malignant effusion.
Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial

Respiratory distress syndrome (RDS) is the most common respiratory disorder in preterm infants. Despite improved survival of extremely premature infants with RDS, complications related to mechanical ventilation still occur. This trial will attempt to maintain adequate gas exchange at a rapid rate, short inspiratory time, low tidal volume, and low peak inspiratory pressure in infants with respiratory distress requiring mechanical ventilation. A cross over design will be used to test the hypothesis whether mid-frequency ventilation in preterm infants with RDS requiring mechanical ventilation will reduce the peak inspiratory pressure requirement when compared to conventional mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Inborn newborn infants with birthweight greater than or equal to 500gms, with gestational age greater than or equal to 24 weeks but less than or equal to 36 weeks.
* Postnatal age less than or equal to 7 days.
* Infant with respiratory distress syndrome (RDS) on mechanical ventilation with less than or equal to 60 breaths/minute, initially requiring greater than or equal to 30% FiO2.
* Written informed consent.

Exclusion Criteria:

* Blood culture positive sepsis, life threatening congenital anomalies, cyanotic congenital heart diseases, hydrops fetalis, outborn infants, non viability as determined by the attending physician, and newborns who are considered too unstable for study enrollment as per neonatology attending/fellow.
Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2006-2007

This study aims to collect data and assess the number of rotavirus related hospitalizations in 11 hospitals in Belgium - season 2006-2007 in order to develop proper age-cohort analysis over time.

This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2006 until the 31st of May 2007. IMS Health sales data will be used to provide rotavirus vaccine coverage estimates (Rotarix and Rotateq) for the Belgian population during the study period. Any additional source of vaccine coverage status describing rotavirus vaccine uptake in the study population will also be reported.

Eligibility Criteria:
Inclusion Criteria:

* Child aged ≤5 years;
* A stool sample has been provided for a rotavirus detection test during the study period;
* Laboratory test result of rotavirus is available.

Exclusion Criteria:

Not applicable.
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)

This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™, 2) to describe the safety of sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given approximately 12 months after receipt of either V114 or Prevnar 13™ in healthy adults 50 years of age or older. There was no formal hypothesis testing.


Eligibility Criteria:
Inclusion Criteria:

* Male or female in good health
* Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of last study vaccine.

Exclusion Criteria

* History of invasive pneumococcal disease
* Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine.
* Known or suspected impairment of immune function
* Coagulation disorder contraindicating intramuscular vaccination
* History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Female participant: positive urine or serum pregnancy test
* Prior administration of any pneumococcal vaccine
* Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry.
* Received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. (Note: Topical, ophthalmic, intra-articular or soft-tissue \[e.g., bursa, tendon steroid injections\], and inhaled/nebulized steroids are permitted).
* Received immunosuppressive therapy
* Received a blood transfusion or blood products within 6 months of enrollment
* Participated in another clinical study of an investigational product within 2 months of enrollment
* Current user of recreational or illicit drugs or history of drug or alcohol abuse or dependence.
Bevacizumab Against Recurrent Retinal Detachment

The investigators hypothesize that bevacizumab instilled into the vitreous after primary retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and subsequent retinal re-detachment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Eyes with rhegmatogenous retinal detachment

Exclusion Criteria:

* Presence of PVR
* Need for a procedure other than primary PPV such as a scleral buckle with or without PPV, laser retinopexy, or pneumatic retinopexy.
* Recent intravitreal injection of an anti-VEGF agent less than 3 months prior
* Secondary retinal detachment repair
* Use of silicone oil as tamponade agent
* Patients less than 18 years of age
* Pregnancy
* Known allergy or contraindication to intravitreal bevacizumab
A Study to Compare the Experiences of Taking Daily Growth Hormone Injections to Weekly Ngenla in Children With Low Levels of Growth Hormone

The purpose of this study is to learn about:

* how children stick to taking their injections
* their experience with the study medicines (Ngenla and daily growth hormone) prescribed to children with low levels of growth hormone.

This study is seeking participants who:

* are being treated or are ready to start treatment with daily growth hormone or Ngenla.
* use a sharps bin to collect used needles.

The study medicines will be given as per regular care agreed with the doctor. The study will compare participant experiences to help us see:

- the difference in how the participants stick to taking their daily growth hormone injections compared to participants using once weekly Ngenla.

Participants will take part in this study for up to 14 months. During this time, they will have 3 study visits at the study clinic. The participants will use the HealthBeacon™ smart sharps bin for collecting the used needles or injections.

This multicenter, international, longitudinal, prospective, site-based, low-interventional study aims to evaluate and monitor treatment experience, defined by treatment adherence and persistence, in children aged 3-16 years old with a diagnosis of pediatric growth hormone deficiency (pGHD), receiving either daily growth hormone (dGH) treatment or once weekly Ngenla. The study is planned to be conducted in a total of 50 participating sites distributed across Belgium, Canada, France, Italy, Luxembourg, Spain, UK, and US.

Data on treatment adherence and persistence will be collected in real-time over a period of 12 months using the HealthBeacon™ Smart Sharps Bin™ as a treatment monitoring device.

Additional data, including demographic and clinical characteristics, will be collected at three timepoints, in line with the routine care in each participating site and/or country, over a maximum period of 14 months.

Approximately 400 participants will be enrolled in the study (approximately 200 participants prescribed dGH injections and approximately 200 prescribed Ngenla).

Eligibility Criteria:
Inclusion Criteria:

1. Children of any sex aged 3-16 years at baseline
2. Children that have received a diagnosis of pGHD requiring GH injections.
3. Children that are currently being treated (dGH/Ngenla) or are treatment naïve but ready to start treatment.
4. Those who currently use a sharps bin to collect used needles \[as per normal standard of care (SoC)\].

Exclusion Criteria:

1. Children with psychosocial dwarfism.
2. Children born small for gestational age (SGA)
3. Children with chromosomal abnormalities
4. Children with other causes of short stature, such as uncontrolled primary hypothyroidism or rickets.
5. Children with a history of cancer.

7. Children with other acute medical or psychiatric condition