cyrilzakka/clinical-trials huggingface dataset:
Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. In severe cases, extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to enable survival of severely affected infants.

Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls.

Therefore, the purpose of this randomized clinical trial in a less severely affected subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO therapy.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women from European countries carrying fetuses with left diaphragmatic hernia.
* Normal karyotype, no further severe anomalies on prenatal ultrasound study.
* Fetal liver herniation into the chest; gestational age-related lung volume between 20-25% of normal as determined by magnetic resonance imaging between 30+0 - 34+0 weeks+days of gestation.

Exclusion Criteria:

* Any maternal disease or condition that would result in an increased risk to her health from the experimental procedure.
* Abnormal fetal karyotype, further severe fetal anomalies on prenatal ultrasound.
ZD 1839 Plus Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. ZD 1839 may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether chemotherapy is more effective with or without ZD 1839 for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without ZD 1839 in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES: I. Compare the 1 year survival rate, time to worsening of disease related symptoms, and progression free survival in chemotherapy naive patients with stage IIIB or IV non-small cell lung cancer treated with one of two doses of ZD 1839 or placebo combined with gemcitabine and cisplatin.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of three treatment arms. Patients receive gemcitabine and cisplatin combined with lower dose oral ZD 1839 (arm I), higher dose oral ZD 1839 (arm II), or placebo (arm III).

PROJECTED ACCRUAL: A total of 1,029 patients (343 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven non-small cell lung cancer Stage III disease that is not curable with surgery or radiotherapy OR Stage IV disease Chemotherapy naive

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 WBC at least 4,000/mm3 Hepatic: ALT and AST less than 2.5 times upper limit of normal (ULN) (less than 5 times ULN if liver metastasis present) Bilirubin less than 1.25 times ULN Renal: Creatinine less than 1.5 times ULN Creatinine clearance greater than 60 mL/min Cardiovascular: No evidence of severe or uncontrolled cardiovascular disease Pulmonary: No evidence of severe or uncontrolled pulmonary disease

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent systemic endocrine therapy that is known to have an effect on non-small cell lung cancer Radiotherapy: See Disease Characteristics Prior localized irradiation allowed Surgery: See Disease Characteristics Prior surgery allowed Other: No concurrent drugs with known significant cytochrome P450 3A4 inhibitory effects (e.g., ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem, verapamil)
Paranasal Sinus Volumes of Maxillary Deficiency Patients Requiring Le Fort Osteotomy

The present study aims to compare ethmoid, sphenoid and maxillary sinus volumes of patients with maxillary deficiency requiring Le Fort osteotomy with healthy patients, by employing computed tomography imaging. No accessible information could be found on this subject during literature search. The authors believe anatomical knowledge of these structures in patients with maxillary deficiency will influence all branches performing surgeries in these areas.

The anatomy of the paranasal sinuses is important for many surgeon groups. The precise knowledge of such structures with variable anatomy will be important for the preservation of these structures and the management of complications in surgeries such as endoscopic sinus surgery and osteotomies involving the maxilla such as Le Fort osteotomies. The maxillomandibular complex is often affected by developmental problems and growth problems, and unilateral, bilateral, horizontal, vertical and / or transverse deficiencies are observed. Treatment of this complex is often performed by surgical intervention involving one or both jaws. In surgeries involving the maxilla, maxillary sinuses are affected by the surgery and affect the course of surgery. Paranasal sinuses are also very important structures for closely related endoscopic sinus surgeries. Detailed preoperative investigation is crucial for patient selection and hence desired outcome. Study was conducted in Ankara University Faculty of Dentistry with Ethical approval number:08/03. Computed tomography scans of 120 patients (59 maxillary deficiency patients and 61 healthy controls) were included in the study. CT scan indications for the group with maxillary deficiency was surgical preparation for Le Fort I osteotomy. The control group had no maxillary deficiency and CT images were obtained for several reasons such as temporomandibular disease, preparation for orthodontic treatment, obstructive sleep apnea and also paranasal sinus imaging Patients with a history of trauma in the midline skull base were excluded. Statistically significant results were obtained between groups for ethmoid and maxillary sinus volumes (left and right). Ethmoid and maxillary sinus volumes (left and right) were smaller in the Le Fort group. No statistically significant differences were present for sphenoid sinus volume of two groups and for the left and right maxillary sinus volumes in both groups.

Eligibility Criteria:
Inclusion Criteria for the study group:

- Maxillary deficiency (CT scans involving the head and paranasal sinuses, obtained for Le Fort I osteotomy).

Inclusion Criteria for the control group:

-Healthy patients. (CT scans involving the head and paranasal sinuses, obtained for several reasons such as temporomandibular disease, preparation for orthodontic treatment, obstructive sleep apnea and also paranasal sinus imaging, no maxillary deficiency).

Exclusion Criteria: Patients with a history of trauma in the midline skull base were excluded.
Identification and Characterization of the Methylation Abnormalities on Whole Genome Among Infertile Men

This study will analyse the sperm global methylation status of 62 infertile men before assisted reproductive techniques. Some of these patients (20%) present hypomethylation of H19 locus. A global methylation analysis may reveal others imprinting defects.

An increase of the abnormalities of the imprint was brought back at the child's stemming from assisted reproductive techniques. Now abnormalities of methylation could be implied in defects of spermatogenesis and certain abnormalities of development of the male germ cells could be due to modifications abnormal epigenetics.

The objective of this research is to determine the frequency of arisen the abnormalities of methylation at the level of the locus H19 in the sperm cells of barren men presenting an unexplained oligozoospermia and to determine if these changes are a reflection of abnormalities of the profiles of methylation of the whole genome.

The patients will realize a taking of sperm having signed the consent.

Eligibility Criteria:
Inclusion Criteria:

* Men from 18 to 45 years old, presenting an idiopathic oligozoospermia lower than 10 million sperm cells / ml and include in a program of medically assisted conception
* Patients with social security
* Patients having signed the informed consent

Exclusion Criteria:

* Infertility with a neoplastic origin: patients subjected to a treatment potentially sterilizing (chemotherapy or radiotherapy).
* Infertility with an infectious origin
* Infertility with a traumatic origin
* Infertility bound to a chromosomal abnormality or a microdeletion of Y
* Histories of cryptorchidism, of varicocele
Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer

Determine clinical and pathological factors associated with perioperative morbidity and mortality, and oncological outcomes after multivisceral en bloc resection in patients with colorectal cancer.

Between January/2009 and February/2014, 105 patients with primary colorectal cancer selected for multivisceral resection were selected from a prospective database. Clinical and pathological factors, perioperative morbidity and mortality and outcome were verified from medical records. Estimated local recurrence, and overall survival were compared using the log rank method, and Cox regression analysis was used to determine the independence of the studied parameters.

Eligibility Criteria:
Inclusion Criteria:

* T4 Colorectal cancer -

Exclusion Criteria:

* Non primary Colorectal cancer -
Impact of Nutritional Deficit in Emergency Surgery

Patients in emergency settings might become malnourished. There are different ways to identify the group as 'at risk' of malnutrition. There are also several different ways to measure outcomes. This pilot study will look at patients undergoing emergency laparotomy, investigate relationships between different selection criteria and outcome measures, and test feasibility of outcome measure collection.

Patients in emergency settings might become malnourished. There are different ways to identify the group as 'at risk' of malnutrition. There are also several different ways to measure outcomes. This pilot study will look at patients undergoing emergency laparotomy, investigate relationships between different selection criteria and outcome measures, and test feasibility of outcome measure collection.

Eligibility Criteria:
Inclusion Criteria:

* Willing to consent,

  -≥ 18 years old
* eligible for inclusion in National Emergency Laparotomy Audit
* first procedure during admission (\<7 days from admission).

Exclusion Criteria:

* Recent discharge from hospital (within 60 days),
* unable to provide informed consent
* life expectancy \<12 months
* prisoners
* lack mental capacity
* language barrier affecting ability to provide consent
Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5

To establish the tolerability and preliminary efficacy of Cand5 by a single intravitreal injection in patients with wet age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Patients with subfoveal predominantly classic, minimally classic and purely occult lesions, secondary to age related macular degeneration, with a total lesion size (including blood, atrophy/scar and neovascularization) of \< 12 total disc areas, of which at least 50% are active CNV.
* Patients must have visual acuity 20/50 to 20/320 in the study eye.
* Patients must have better visual acuity in the fellow eye than the study eye.
* Subretinal hemorrhage (if any) must comprise no more than 50% of total lesion size.

Exclusion Criteria:

* Patients with concomitant eye disease, including glaucoma, uveitis, diabetic retinopathy, presence of pigment epithelial tears or rips, acute ocular or periocular infection in the study eye.
* Patients with \> 3 prior PDT treatments with Visudyne in the study eye.
* Patients who received PDT in the study eye within eight weeks prior to the baseline angiography/photography.
Diacutaneus Fibrolysis on Tempromandibular Joint Pain and Trismus Post Oral Surgery

This study is carried out on sixty patients who will have tempromandibular pain and trismuspostOral and Maxillofacial Surgeryand their ages will be ranged from 18 to 40 years.


Eligibility Criteria:
Inclusion Criteria:

1. Ages of patients will be ranged from 18 to 40 years.
2. All patients will have Oral and Maxillofacial Surgery.
3. All patients will be referred by a surgeon before starting the study procedure.
4. All participants will have pain and trismus in the jaw,
5. The participants will be also cleared for periodontal issues.
6. All patients will enter the study having their informed consent

Exclusion Criteria:

1. Patients with associated vascular injuries requiring arterial repair.
2. Patient with systemic diseases such as arthritis; pain attributable to confirmed migraine, head, or neck pain condition
3. Patient with acute infection or other significant disease of the teeth, ears, eyes, nose, or throat
4. Patient with present neurologic or cognitive deficit.
5. Patients with history of previously failed surgeries.
Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease

To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease, the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Chronic, well-compensated stable liver
* Hypercholesterolemia

Exclusion Criteria:

* Signs or symptoms of ascites, jaundice, or cirrhosis with a Child-Pugh Score \> 5
* History of disorders affecting serum bilirubin levels, more than 1 chronic liver disease, significant endocrine, renal, or gastrointestinal disease, or uncontrolled hypertension
* Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol
Optimal VAsopressor titraTION Pilot Randomized Controlled Trial

The purpose of this research study is to determine if it is better to give vasopressors to patients to maintain a higher blood pressure target versus a lower blood pressure target. This study is important because the information we find out will help us know how best to administer vasopressors in patients with shock in the ICU.

Patients who are admitted to the intensive care unit (ICU) commonly suffer from shock, a condition that causes life-threatening low blood pressure. Low blood pressure makes it difficult for the body to deliver blood to all of its organs. The standard treatment doctors in the ICU use for their patients is to give medications that help increase blood pressure. These medications are called vasopressors. There can be side effects related to using vasopressors. The purpose of this research study is to determine if it is better to give vasopressors to patients to maintain a higher blood pressure target versus a lower blood pressure target. This study is important because the information we find out will help us know how best to administer vasopressors in patients with shock in the ICU.

Eligibility Criteria:
Inclusion Criteria:

1. Who are receiving vasopressors for distributive shock
2. Who are older than 16 years of age at the time of eligibility.
3. Who are under the direct care of the ICU team regardless of location.
4. Who have received a minimum of 30 mL/kg of intravenous fluids (2100 mL for a 70 kg patient) before enrolment OR the most responsible physician has good reasons to believe that more fluid resuscitation is no longer required and could be harmful.
5. Who the treating physician believes will need vasopressors for at least 6 hours once enrolled.

Exclusion Criteria:

1. Have received vasopressors for more than 24 consecutive hours; if vasopressors are discontinued for \>= 2 hours then restarting vasopressors will constitute a distinct vasopressor episode and the clock will be reset.
2. Are judged by the treating physician to be in obvious cardiogenic shock after an acute myocardial infarction (based on new ST segment elevations on ECG or obvious echocardiographic findings).
3. Have obvious haemorrhagic shock as a consequence of a clearly identified source of blood loss.
4. Require vasopressors after cardiac surgery as a result of cardiopulmonary bypass-induced hypotension.
5. Who have a specific indication for catecholamine therapy other than shock (i.e. angioedema or intracranial hypertension).
6. If the attending team has agreed to withhold or withdraw life sustaining care.
7. Concurrent enrollment in interventional trials that do not meet guidelines (see ccctg.ca) for co-enrollment (co-enrollment is permissible if there is no potential interaction between the protocols; this will be addressed case by case).
8. Prior randomization in this study.
Neural Circulatory Control and SUDEP Risk.

The investigators believe epilepsy alters the way the body controls blood pressure, heart rate and breathing, and these changes increase the risk of sudden unexpected death in patients with epilepsy (SUDEP). SUDEP-7 is a risk scoring tool which may correlate with these changes to the heart and blood vessels. This research study measures those differences which may help identify new markers to help predict those patients at greatest risk in the future.

The investigators overall goals are to determine whether measures of neural-circulatory control during the interictal waking and sleep states, as well as during the ictal/peri-ictal periods, are associated with SUDEP-7 score risk profiles in refractory epilepsy patients, and to translate these measures into tools for risk-stratification and preventative strategies for SUDEP.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-90
* Able to consent

Exclusion Criteria:

* History of non-epileptic spells/seizures,
* Children/adolescents under age 18 years
* Pregnancy
* Non-compliance with Epilepsy Monitoring Unit safety procedures
* Unable to consent
* History of dysautonomia
* Chronic Obstructive Pulmonary Disease (COPD)
* Asthma (active requiring therapy)
* Pulmonary hypertension
* Known Structural Heart Disease
* Heart failure
* Myocardial infarction
* Stroke
* Seizures due to traumatic injury
* Prior surgery for epilepsy
* Vasculitis
* Raynaud's
* Smoking (current or within the last 6 months)
Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome

Idiopathic Nephrotic Syndrome (INS) is the first glomerulopathy in children and 60% of the patients develop Steroid-Dependant Nephrotic Syndrome (SDNS). Recently, rituximab (RTX), a humanized anti-CD20 antibody depleting B cells demonstrated the ability to increase relapse free survival and to decrease the number of relapse and the need of other immunosuppressive drugs. However, the remission rate after 2 years is only 30 to 40%.

The aim of the study is to study the ability of intravenous Immunoglobulin to improve remission rate in SDNS when added associated with Rituximab compared to a treatment by Rituximab alone.

Idiopathic Nephrotic Syndrome (INS) is the first glomerulopathy in children and 60% of the patients develop Steroid-Dependant Nephrotic Syndrome (SDNS). Depleting B cells demonstrated the ability to increase relapse free survival and to decrease the number of relapse and the need of other immunosuppressive drugs. However, the remission rate after 2 years is only 30 to 40%.

The aim of the study is to study the ability of intravenous Immunoglobulin to improve remission rate in SDNS when added associated with Rituximab compared to a treatment by Rituximab alone.

Eligibility Criteria:
Inclusion Criteria:

* Childhood onset nephrotic syndrome (first flair \<18 years)
* ≥ 2 years old at inclusion
* Steroid-dependent:

  * Patient with at least 2 relapses confirmed during the decay of corticosteroids or within 2 weeks following steroids discontinuation.
  * Patient with at least 2 relapses including one under steroidsparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, Levamisole) or within 6 months of treatment withdrawal.
* or with frequent relapses:

  · 2 or more relapses within 6 months after initial remission or 4 or more relapses within any 12-month period.
* with a relapse within 3 months prior to inclusion
* In remission: Protein-over-creatinine ratio ≤ 0.2g/g (≤ 0.02g/mmol)

Exclusion Criteria:

* Patients with steroid-resistant nephrotic syndrome;
* Patients with genetic nephrotic syndrome;
* Patients previously treated with rituximab;
* Patients with no affiliation to a social security scheme (beneficiary or legal);
* Prior Hepatitis B, Hepatitis C or HIV infection;
* Pregnancy or breastfeeding.
* Patients with hyperprolinaemia,
* Known hypersensitivity to one of the study medication,
* Scheduled and not postponable injection of live attenuated vaccine
* Protected adults
* Patients with neutrophils \< 1.5 G/L and/or platelets \< 75 G/L
Evaluation of the Acceptability and Feasibility of a Bedtime Routine for Neonates

The purpose of this study is to assess, via caregiver questionnaire, the acceptability and feasibility of implementing a bedtime routine for newborns.


Eligibility Criteria:
Inclusion Criteria:

Infant:

* Full term at birth (gestational age greater than or equal to \[\>=\] 37 weeks)
* A singleton birth. (Having other infants/children in the household will be allowed but only 1 child per household may be enrolled)
* Breastfed, formula-fed, or combination

Caregiver:

* Able to read, write, speak, and understand English
* Must be the parent (biological or adoptive) and legal guardian of the infant participant who is willing and able to present proof of legal guardianship (example: birth certificate/hospital discharge paperwork along with valid ID of legal guardian, etc.)

Exclusion Criteria:

Caregiver and infant:

* Has known allergies or adverse reactions to common topical skincare products or the ingredients in the investigational study materials
* Has a history of or a concurrent health condition/situation which, in the opinion of the Principal Investigator (PI) or Study Physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
* Is simultaneously participating in any other clinical study or has participated in a clinical study since infant's birth
* Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor
* Presents with a skin condition that may influence the outcome of the study (specifically psoriasis, eczema, atopic dermatitis, or erythema)