cyrilzakka/clinical-trials huggingface dataset:
Continuous Positive Airway Pressure (CPAP) Pediatric Patients With Subglottic Stenosis Who Undergo Balloon Dilatation

Nasal continuous positive airway pressure (CPAP) acts as a 'pressure' bridge between spontaneous breathing and controlled mechanical ventilation. As a result, there is an increasing trend in the prophylactic use of nasal CPAP in pediatric patients following high-risk airway procedures to reduce postoperative airway complications. Still, there is no study published on the prophylactic use of balloon dilatation in children with tracheal stenosis.The study hypothesizes that implementing postoperative prophylactic CPAP in pediatric cases with subglottic stenosis undergoing balloon dilation may shorten recovery time and minimize airway complications.

Acquired pediatric subglottic stenosis is reported to have a prevalence of 1-2% . This rate reaches 8.3% in different case series. Acquired pediatric subglottic stenosis is commonly attributed to prolonged intubation, whereas the etiology also involves a history of traumatic or difficult airway. Balloon dilation laryngoplasty is an efficient and safe technique for treating primary and secondary acquired laryngotracheal stenosis. It is successfully applied in these children. Airway surgery typically necessitates a deeper level of anesthesia to control airway reflexes and manage the fluctuations in hemodynamic parameters, which are characteristic of this surgery.

Nevertheless, general anesthesia must be applied several times to patients due to the need for multiple balloon dilatations. At the same time, the procedure also necessitates coping with postoperative complications that may arise. Because alveolar collapse, which is related to general anesthesia, impairs gas exchange by creating a shunt effect, potentially increasing perioperative hypoxemic episodes, which in turn increases the risk for postoperative pulmonary complications. A recent retrospective analysis found that 40.6% of children who underwent balloon dilation experienced desaturation. Additionally, tracheotomy was required in 15.6% of cases, with an equal percentage needing tracheal intubation.

Prophylactic CPAP in pediatric cases has been shown to improve oxygenation by reducing the alveolar-arterial oxygen difference after pediatric laparoscopic surgery. However, it has been proven that CPAP applied after pediatric cardiac surgery has favorable effects on peak expiratory flow.

Eligibility Criteria:
Inclusion Criteria:

* ASA 2-3
* acquired or congenital subglottic stenosis

Exclusion Criteria:

* congenital or acquired diseases of the primary lung or choanal atresia
* younger than 38 gestational weeks
* intubated patients
* congenital cardiac defects
Post Marketing Surveillance Study of Actimmune in Patients With Severe, Malignant Osteopetrosis

The purpose of this study is to establish a registry of all children with severe, malignant osteopetrosis who are treated with Actimmune (IFN-g 1b or Interferon gamma-1b) to monitor the effects of IFN-g 1b on preventing progression of this disease and to follow the safety of patients receiving it on a long-term basis. In addition, evaluation of the possible effect of Actimmune therapy on the humoral response to normal childhood vaccinations in this same patient population will be examined.Interferon gamma is a substance that the body makes naturally.

It is made by white blood cells and appears to be involved in regulating the body's ability to fight off infection. Actimmune is a synthetic form of Interferon gamma which is similar to that normally made by white blood cells.

IFN-g 1b (Actimmune®) is currently approved by the United States Food and Drug Administration (FDA) for the treatment of patients with chronic granulomatous disease (CGD) to reduce the frequency and severity of serious infections. It is also approved in patients with severe, malignant osteopetrosis to delay the time to disease progression. In research trials, IFN-g 1b has been given to over 2,000 patients in diseases such as CGD, osteopetrosis, atopic dermatitis, pulmonary fibrosis, atypical mycobacteria and various cancers.

Eligibility Criteria:
* Male or female
* Diagnosis of severe, malignant osteopetrosis
* Currently receiving or planning to initiate therapy with Actimmune (Interferon gamma-1b)
* Willing to attend follow-up appointments every 6 months following enrollment into the study, if clinically indicated
A Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting

This study evaluated the quality of life (QOL) and economic impact of adalimumab treatment in participants with ulcerative colitis (UC).

This was a single arm, open-label, multicenter study. The primary objectives were to study the effect of adalimumab on QOL (as measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)), the utilization of health care resources, and the costs of care for subjects with UC who were treated with adalimumab in the usual clinical practice setting. The secondary objectives were to further assess the effect of adalimumab on disease activity and to collect additional safety data in subjects with UC.

Eligibility Criteria:
Inclusion Criteria:

1. Participants had to be a male or female between the ages of 18 and 75 years old at the time of the Screening Visit.
2. Participants who had a diagnosis of ulcerative colitis (UC) greater than 90 days prior to baseline (week 0) and failed conventional treatment.
3. Participants diagnosis of active UC was confirmed by a colonoscopy with biopsy or flexible sigmoidoscopy with biopsy.
4. Participants who had active UC with a Physicians Global Assessment (PGA) score of 2 or 3 and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) ≤ 45 at baseline (week 0).
5. Concurrent therapy was required for participants who were previously treated with corticosteroids or immunosuppressants (azathioprine (AZA) or 6-mercaptopurine (6-MP)) and, in the judgment of the investigator, had failed to respond to or could not tolerate their treatment. Participants had to be on a concurrent treatment with at least one of the following (oral corticosteroids or immunosuppressants or both as defined below):

   * Stable oral corticosteroid dose (prednisone ≥ 20 mg/day or equivalent) for at least 14 days prior to baseline, or
   * Stable oral corticosteroid dose (prednisone \< 20 mg/day) for at least 21 days prior to baseline, and/or
   * At least a consecutive 12 weeks (84 days) course of AZA or 6-MP prior to baseline.

Exclusion Criteria:

1. Participants who had a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery.
2. Participants received previous treatment with adalimumab or previous participation in an adalimumab clinical study.
3. Participants who had previously used infliximab or any anti- tumor necrosis factor (TNF) agent within 56 days of baseline (week 0).
4. Participants who had previously used infliximab or any anti-TNF agent and had not clinically responded at any time ("primary non-responder") unless they experienced a treatment limiting reaction.
5. Participants who had received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of baseline (week 0).
6. Participants who had received intravenous (IV) corticosteroids within 14 days of Screening or during the screening period.
7. Participants who had a current diagnosis of fulminant colitis and/or toxic megacolon.
Effectiveness of Bilateral Ultrasound-Guided Erector Spinae Plane Block

The proposed mechanism of action of the ESPB is via blockade of the dorsal and ventral rami of the spinal nerves and sympathetic nerve fibers. Radiographic evidence suggests that local anesthetic injected into at the ESP spreads both cranially and caudally as the plane is continuous along the vertebral column . ESPB reportshave demonstrated analgesia at cervical, thoracic, and lumbar levels for procedures such aspyeloplasty, lipoma excision, breast reconstruction,malignant mesothelioma, inguinal hernia repairs, and hip reconstructions

One of these local analgesia is the erector spinae plane block (ESPB). it was first described in 2016 as a regional block for the treatment of thoracic neuropathic pain. This has shown promise as an alternative to neuraxial blockade for a variety of surgeries with good effect. In addition, the block has a reduced risk of epidural hematoma, direct spinal cord injury, and central infection .

The proposed mechanism of action of the ESPB is via blockade of the dorsal and ventral rami of the spinal nerves and sympathetic nerve fibers. Radiographic evidence suggests that local anesthetic injected into at the ESP spreads both cranially and caudally as the plane is continuous along the vertebral column . ESPB reportshave demonstrated analgesia at cervical, thoracic, and lumbar levels for procedures such aspyeloplasty, lipoma excision, breast reconstruction,malignant mesothelioma, inguinal hernia repairs, and hip reconstructions

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 18 to 60 years.
* Genders eligible for study: both sexes.
* ASA I-II.
* Undergoing lumbar spine surgeries in any 2 levels(L1-L5).
* BMI from 18.5 to 30 kg/m2

Exclusion Criteria:

* Patient refusal
* Contraindications to regional anesthesia (Bleeding disorders, Use of any anti-coagulants, local infection, etc.).
* Known allergy to local anesthetics.
* ASA III-IV.
* Patients aged less than 18 or more than 60.
* Body mass index \>35.
* Patients with difficulty in evaluating their level of pain.
* Patients with secondary surgery or surgery involving more than two intervertebral spaces were excluded.
Hyperspectral Imaging Pre and Post Endovascular Intervention

This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.

This will be a nonrandomized, nonblinded, prospective observational study to correlate the results obtained with the traditional measures of success of endovascular revascularization of peripheral arteries for the treatment of chronic limb ischemia; i.e., ABPI, PVR with oxyhemoglobin (OxyHb) and deoxyhemoglobin (DeoxyHb) measurements obtained with a new imaging device manufactured by HyperMed Inc (OxyVu) that uses hyperspectral technology.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with established diagnosis of lower limb ischemic based on their symptoms of claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory tests that are currently used to make this diagnosis and have been scheduled for endovascular revascularization.
2. Age group between 50-85
3. Gender - Male or Female
4. Race - all race and ethnicities

Exclusion Criteria:

1. Patients with known cardiac disease - new MI (within 3 months).
2. Patients with hypertension with the systolic BP \>200 or diastolic BP\>110 on the day of testing
3. Patients on supplemental O2 for chronic obstructive lung disease
4. Bed-ridden subjects - either due to chronic disability or neurological problems
Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing daily dose starting at the fifth week after initiation of IMRT might improve tumor control and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The study is designed to test if late-course accelerated hyperfractionated IMRT can improve the outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with locoregionally advanced nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven non-keratinizing or undifferentiated type nasopharyngeal carcinoma for primary treatment with curative intent
* According to AJCC 2002 Staging System, clinical stage must be Ⅱb-Ⅳb
* Age between 18-70
* Karnofsky performance status ≥70
* WBC ≥4,000/mm3, PLT ≥ 100,000/mm3,serum creatinine ≤ 1.6 mg/dl
* Without radiotherapy or chemotherapy
* Signed study-specific consent form prior to study entry

Exclusion Criteria:

* Patients with distant metastasis
* Pregnant or lactating women
* The presence of uncontrolled life-threatening illness
* Patients who received radiotherapy or chemotherapy previously
Triferic AVNU Infusion Via Freedom Pump During Hemodialysis

The main purpose of this study is to evaluate the delivery of Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the pre-dialyzer and post-dialyzer blood lines.

This is a single center, multi dose, open label study assessing the delivery of Triferic AVNU administered intravenously to adult patients (\> or equal to 18 years of age) using the Freedom Pump-20 during hemodialysis into the pre-dialyzer and post-dialyzer blood lines.

Eligibility Criteria:
Inclusion Criteria:

1. Participant must be 18 years of age inclusive, at the time of signing the informed consent.
2. Receiving chronic hemodialysis for 3-4 hours each session 3x/week.
3. Medically stable according to the investigator opinion
4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

1. Hemodynamically unstable during hemodialysis
2. Evidence of active bleeding from the GI tract.
A Study of Clinical Outcomes in Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Greece

This study is being done to evaluate the clinical outcomes of Chronic Lymphocytic Leukemia (CLL) participants treated with venetoclax as routine standard of care in Greece. The decision to treat with venetoclax is made by the participant's physician prior to being offered enrollment in this study.

The objectives of this study include determining overall response rate, assessing safety information, analyzing patient profiles and disease characteristics and participant quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
* Eligible to receive venetoclax as per local label
* Physician has decided to initiate CLL treatment with venetoclax and the decision to treat is made by the physician in accordance with the local label prior to any decision to approach the participant about the study
* Participant has been fully informed verbally and in writing about the study and does not object to their data being processed or subjected to data quality control

Exclusion Criteria:

* Prescribed or treated with venetoclax outside of marketing authorization
* Currently participating in, or previously participated within 30 days prior to venetoclax start, in any other interventional clinical trial
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty

The purpose of this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after total knee arthroplasty.

Total knee arthroplasty (TKA) is increasingly common in the treatment of osteoarthrosis. Despite aggressive analgesic regimes, TKA is associated with moderate to severe postoperative pain, delaying mobilization and hospital discharge. A relatively new method for controlling postoperative pain after TKA is local infiltration analgesia (LIA) which consists of local infiltration with Ropivacaine and adrenaline.3 studies haved showed promising results of LIA, but none have documented a superior analgesic effect versus placebo.Patients receiving bilateral knee arthroplasty are recruited to receive LIA and placebo infiltration.The aim of the study is to demonstrate an analgesic effect of LIA versus placebo.

Eligibility Criteria:
Inclusion Criteria:

* patients eligible for total knee arthroplasty
* must speak and understand Danish
* must be able to give oral and written consent

Exclusion Criteria:

* Alcohol or medicine abuse
* Treatment with opioids
* Allergy to local anaesthetics
* Severe obesity
fMRI and IVCM Cornea Microscopy of CXL in Keratoconus

Evaluation of neuroplasticity of pain pathways and corneal afferent nerve regeneration following corneal crosslinking (CXL) in keratoconus patients using fMRI and corneal In Vivo Confocal Microscopy (IVCM).

Our long-term goal is to evaluate the transition from acute to chronic pain that sometimes occurs following CXL in keratoconus patients. This study will determine whether these changes can be structurally and functionally quantified using functional neuroimaging and in vivo corneal microscopy (IVCM), and whether they can be predicted based on predisposing biological and psychological factors. Our central hypothesis is that CXL produces acute pain through activation of trigeminal afferents, and that post-operative chronic pain outcomes are related to neuroplastic changes in trigeminal circuitry, corneal afferent regeneration, and psychological factors.

Eligibility Criteria:
Inclusion Criteria:

CXL Group

* Age 8-35 years
* Clinical diagnosis of keratoconus and seeking CXL treatment
* English speaking ability sufficient to comprehend consent with parental assistance
* MRI compatible
* Ability to lie still for an MRI session (60 minutes)

Control Group

* Age 8-35 years
* No diagnosis of keratoconus
* English speaking ability sufficient to comprehend consent with parental assistance
* MRI compatible
* Ability to lie still for an MRI session (60 minutes)

Exclusion Criteria (Both Groups):

* Claustrophobic
* Weight \> 285 lbs (weight limit of the MRI table)
* Significant medical history, including:

Current DSM-IV-TR axis I psychiatric disorders. Chronic pain Significant head injury Seizures Brain tumor Cerebrovascular accident Neurological disease aside from migraine HIV-AIDs Prescription medication strongly implicated in causing dry eyes

* Magnetic implants or metal-containing tattoos on their chest or above
* Pregnancy
* History of contact lens wear
* Any allergic response to a numbing eyedrop in the past
A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C

This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects (Part A) or patients with chronic hepatitis C infection (Part B), 18 to 60 years of age, inclusive
* Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a minimum weight of 45 kg
* Female subjects/patients must be surgically sterile or post-menopausal
* Male subjects/patients and their partners of childbearing potential must use 2 methods of contraception
* For HCV patients:
* Hepatitis C genotype 1 of \> 6 months duration at screening
* HCV RNA quantifiable (Roche COBAS TaqMan HCV Test) at screening
* HCV treatment-naïve (no prior antiviral therapy for chronic hepatitis C with interferon-based therapy)
* Liver biopsy or non-invasive procedure within the past 2 years showing absence of cirrhosis

Exclusion Criteria:

* Pregnant or lactating women, and male partners of women who are pregnant or lactating
* Positive test for drugs of abuse
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams or 1 unit of alcohol
* History or symptoms of any significant disease or disorder
* History of active malignancy within the last 5 years, except for localized or in situ carcinoma (e.g. basal or squamous cell carcinoma of the skin)
* Positive for hepatitis B or HIV infection, and/ or for HCV for healthy volunteers (Part A)
* For HCV patients:
* Decompensated liver disease or impaired liver function as defined by any history of ascites, hepatic encephalopathy, hepatocellular carcinoma or bleeding esophageal varices, or prothrombin international normalized ratio (PTINR) \>/= 2.0 at screening
* Evidence of cirrhosis and/or incomplete transition to cirrhosis
* Presence or history of non-hepatitis C liver disease
Effects of Circadian Rhythm on Glycemic Regulation During Continuous Moderate Exercise and Intense Intermittent Disease in Adolescents Living with Type 1 Diabetes

Interventional research with minimal risks and constraints on the effects of circadian rhythm on glycemic regulation during intense moderate, continuous and intermittent exercise in adolescents living with type 1 diabetes

Single-center, randomized, controlled study in adolescents living with type 1 diabetes. This study aims to evaluate the effect of exercise timing (morning vs. afternoon) and exercise type (continuous vs. intermittent) on blood glucose levels during and after exercise, as well as to assess the effect of exercise timing (morning vs. afternoon) and type of exercise (continuous vs. intermittent) on blood glucose during and after exercise

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 10 to 16;
* Living with type 1 diabetes for at least 1 year with HbA1c less than or equal to 12%;
* Socially insured ;
* Having given their written consent to participate in the research, as well as that of their legal guardians;
* Willing to comply with all research procedures and duration.

Exclusion Criteria:

* Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate less than 40 ml/min), neuropathy or severe proliferative retinopathy as assessed by the investigator;
* Recent acute macrovascular event (\< 3 months), e.g. acute coronary syndrome or cardiac surgery;
* Abnormal blood picture and/or anemia;
* Current pregnancy;
* Other serious medical condition likely to interfere with study participation or ability to complete exercise periods in the judgment of the investigator (e.g., orthopedic limitation);
* Inability to receive informed information;
* Inability to participate in the entire study;
* Lack of social security coverage;
* Refusal to sign consent form.