cyrilzakka/clinical-trials huggingface dataset:
Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index

The object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population.

Several environmental factors and comorbid conditions have been found to be associated with psoriasis in adults, including obesity, depression, smoking, and other cardiovascular risk factors such as high blood pressure. The object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population.

This is a multi-center study with a planned total enrollment of about 200 subjects ages 2-17 years old with psoriasis and 100 aged-match controls. Patient and family history will be recorded. All subjects will undergo standard height, weight, blood pressure, and waist circumference (WC). For the obese and overweight subjects we will also obtain their growth charts to attempt to correlate weight gain with psoriasis onset and progression. All data will be compiled and then statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be between the ages of 5 and 17 years at the time of enrollment.
* Subjects of either sex.
* Subjects who have had psoriatic plaques for more than 6 months.
* Subjects and guardians of minors must sign the approved IRB consent form(s) prior to initiation of the study protocol.
* Subjects enrolled as "non-inflammatory" normal controls will carry a common non- systemic skin condition, such as acne, nevi, warts and molluscum as their main diagnosis.
* Subjects enrolled as "inflammatory" normal controls will carry a diagnosis of moderate to severe atopic dermatitis.

Exclusion Criteria:

* Subjects who are unable to give informed consent or assent.
* Subjects who have had psoriasis for less than 6 months.
* Subjects whose condition is deemed unsafe or incapable by the study investigator for study participation.
Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections

Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis. The aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery.

Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis.

The aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery. It is a multicenter French cohort study. Lymphocytes counts are obtained from patients undergoing pulmonary or digestive cancer surgery before surgery (day-0) as well 1, 3, 5 and 8 days after surgery. Anesthetic and surgical procedures are collected as well as risk factors for postoperative infections recognized in the literature. Clinical and biological signs of infection are collected.

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing digestive or thoracic cancer surgery under general anesthesia.

Exclusion Criteria:

* pregnant women,
* malignant blood disease,
* allograft patient,
* preoperative sepsis or preoperative systemic inflammatory response syndrome.
VAST - Ventricular Arrhythmia Suppression Trial

The purpose of VAST is to determine whether the Rate Smoothing feature in Guidant's PRIZM/VITALITY-family ICDs has an effect on the incidence of ventricular tachyarrhythmias.


Eligibility Criteria:
Inclusion Criteria:

* Patients who receive a commercially available Guidant PRIZM, PRIZM 2, or VITALITY AVT ICD
* Patients who sign and date a Patient Informed Consent prior to study enrollment
* Patients who remain in the clinical care of physicians of their implanting center

Exclusion Criteria:

* Patients who have chronic atrial fibrillation. Paroxysms of AF are not an exclusion criterion, but the patient must be in normal sinus rhythm at the time of randomization. If history of AF is unknown or uncertain, or the patient was recently cardioverted, there must be at least 23 hours of normal sinus rhythm within the 24 hour period preceding randomization
* Patients who previously had an ICD
* Patients with current indications for cardiac resynchronization therapy with defibrillation (CRT-D)
* Patients whose life expectancy is less than 12 months due to other medical conditions
* Patients who are expected to receive a heart transplant during the duration of the study
* Patients who have or who are likely to receive a tricuspid or other valve prosthesis
* Patients who are currently enrolled in another investigational study of active medical therapy. Each instance should be brought to Guidant's Clinical Application Research Studies (CARS) group to determine eligibility
* Patients who are younger than 18 years of age
* Patients who are mentally incompetent and cannot give a Patient Informed Consent or participate in the study
Safety Study Of SNX-5422 To Treat Solid Tumor Cancers And Lymphomas

Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in patients with cancer.


Eligibility Criteria:
Inclusion Criteria:

* Solid tumors or lymphoid malignancies refractory to standard therapy
* measurable disease
* recovery to Grade \< 1 toxicity due to prior adverse event or chemotherapy
* no chemotherapy within 4 weeks of entering study
* Age \> 18 years
* Karnofsy \>= 60%
* Life expectancy \> 3 months
* normal or adequate organ and marrow function

Exclusion Criteria:

* receiving other investigational agents
* brain metastases
* uncontrolled medical illness
* HIV+ receiving combination antiretroviral therapy
* significant GI disease
The Efficacy of Chewing Gums Versus Laxative in Early Return of Bowel Function After CS

540 consented women for being enrolled in this clinical trial and candidates for elective cesarean section will be divided into 3 groups:

* Group A, 180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval.
* Group B, 180 women will receive laxatives after their operating room discharge by 3 hours.
* Group C, 180 women as control group, they will not receive neither gum nor oral fluids. They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds .

540 consented women for being enrolled in this clinical trial and candidates for elective cesarean section will be divided into 3 groups:

* Group A, 180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval.
* Group B, 180 women will receive laxatives after their operating room discharge by 3 hours.

Group C, 180 women as control group, they will not receive neither gum nor oral fluids. They will be on intravenous fluid. starting oral fluids after hearing intestinal sounds .

Eligibility Criteria:
Inclusion Criteria:

* all women undergoing elective cesarean section in Kasr Al AI Aini hospital will be candidate for this trial after full explanation of the trial and informed consent to be taken from the women.

Exclusion Criteria:

* cesarean hysterectomy,
* surgical management of severe postpartum hemorrhage
* previous bowel surgery
* women with history of drug consumption,especially opioids
* water and electrolyte disturbances
* pancreatitis or peritonitis
* inability to chew gum
* diabetes, pregnancies accompanied by coagulopathy like pre-eclampsia, hypothyroidism, muscular and neurological disorders
* postoperative admission to intensive care unit
* history of abdominal surgery except cesarean section
* history of postoperative ileus
* patients with drains
Effect of Customized Lateral Nasal Wall Osteotomy on the Pterygomaxillary Separation During le Fort I Down-fracture

The goal of this clinical trial is to show the effect of patient specific lateral nasal wall osteotomy to the pterygomaxillary separation during Le Fort I down-fracture.

Participants will be divided into two treatment groups. In study group, surgery planned according to the patients' indivudial anatomy and in the conventional group, surgery planned according to mean anatomical datas.

Researchers will compare patient specific lateral nasal wall osteotomy to see if it affects the pterygomaxillary junction seperation during le fort I downfracture.

The same surgical team performed the osteotomies under general anesthesia with nasotracheal intubation. Hypotensive anesthesia was applied as a standard protocol in all patients. Orthognathic surgery, including Le Fort I and sagittal split ramus osteotomy, was used to correct skeletal deformities.

Bone osteotomy was initiated on the bilateral wall of the maxilla with piezosurgery after a mucosal incision and flap elevation.Lateral nasal osteotomy (LNO) with Nievert Anderson single guarded osteotome, median septum separation with double guarded U-shaped osteotome, and pterygomaxillary junction separation with curved osteotome were performed before the down-fracture. The only difference between the conventional and study groups was the depth of the LNO. In the study group, LNO was performed at a depth of 2 mm less than the measured distance in the axial section. In the conventional osteotomy group, LNO was performed at 30 mm for females and 35 mm for males, as suggested in the literature. A curved osteotome and a mallet were used in each case to separate the pterygomaxillary junction. The down-fracture of the maxilla was performed using a hook and a bone spreader in all patients. When the maxilla was down-fractured, LNW and the pterygomaxillary separation types were assessed intraoperatively. The maxilla was stabilized in its new position by four L-shaped osteosynthesis mini-plates at the zygomaticomaxillary buttress and the aperture piriformis regions.

Eligibility Criteria:
Inclusion Criteria: The inclusion criteria

* orthognathic surgery to treat malocclusion
* sleep apnea
* jaw asymmetry

Exclusion Criteria:

* cleft lip and palate
* previous orthognathic surgery
* rhinoplasty
Cabozantinib for Metastatic Triple Negative BrCa

In this research study, we are looking at the anti-tumor effects of Cabozantinib (XL184) in metastatic breast cancer. Data suggest that MET expression and activation are important for initiation and progression of triple-negative breast cancer (TNBC). We evaluated the efficacy of cabozantinib (XL184), a novel inhibitor of multiple receptor tyrosine kinases, including MET and VEGFR2, in patients with metastatic TNBC.

OBJECTIVES:

Primary

\* To evaluate the activity of cabozantinib, as defined by objective response rate in patients with triple-negative metastatic breast cancer

Secondary

* To evaluate progression free survival
* To evaluate c-Met and phospho c-Met expression in archival tumor tissue
* To evaluate the incidence of c-Met amplified circulating tumor cells at baseline
* To evaluate potential plasma biomarkers of cabozantinib

DESIGN:

This study uses a two-stage design enrolling 35 patients to evaluate efficacy of cabozantinib based on overall response defined as complete or partial response per RECIST1.1 criteria. The null and alternative overall response rates were 5% and 20%. If one or more patients enrolled in the stage one cohort (n=13 patients) achieve PR or better then accrual proceeds to stage two (n=22 patients).

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed invasive breast cancer with stage IV disease
* Primary tumor and/or metastasis must be ER-negative, PR-negative and HER2-negative
* May have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer. Must be off treatment for at least 21 days prior to enrollment
* Must have discontinued all biologic therapy at least 14 days before enrollment
* May have received prior radiation therapy in the early stage or metastatic setting, but must have completed treatment at least 14 days prior to enrollment
* Must agree to use medically acceptable methods of contraception
* Confirmed availability of formalin-fixed, paraffin-embedded tumor tissue
* Able to swallow tablets

Exclusion Criteria:

* Pregnant or breastfeeding
* Received another investigational agent within 14 days prior to enrollment
* Received prior c-Met inhibitor
* Known brain metastases that are untreated, symptomatic or require therapy to control symptoms
* Psychiatric illness or social situation that could limit ability to comply with study requirements
* Require concomitant treatment in therapeutic doses with anticoagulants or antiplatelet agents
* Diagnosis of another malignancy requiring systemic treatment within the last two years (except non-melanoma skin cancer or in-situ carcinoma of the cervix)
* Known to be positive for HIV
* Active infection requiring IV antibiotics at Day 1 of cycle 1
* Uncontrolled, significant intercurrent illness
* Requires chronic concomitant treatment of a strong CYP3A4 inducer
* tumor in contact with, invading or encasing major blood vessels
* Have experienced clinically significant gastrointestinal bleeding within 6 months, hemoptysis of more than 0.5 teaspoon of red blood within 3 months or other signs indicative of pulmonary hemorrhage within 3 months of enrollment
The Effectiveness of Oral Acyclovir in the Treatment of Molluscum Contagiosum in Children

The investigators will study the effectiveness of acyclovir in the treatment of molluscum contagiosum in assiut university hospital - dermatological out patient clinic the treatment group will receive acyclovir 200 mg 5 times per day the controlled group will receive local KOH solution

Study population:

Site of the study: The outpatient dermatological clinic in Assiut university hospital.

Participants: children (2 -16) years' old attending dermatological clinic in Assiut university hospital and their parents.

Methodology in details:

1. We will use the social media as " Facebook" to invite patient to visit the clinic and follow up them due to the protective measures of covid 19.
2. Diagnosis of the patient with molluscum contagiosum according to the clinical picture
3. Collecting data including personal and clinical data through interviewing the patient and his or her parents
4. Pictures of the lesions will be taken before and after treatment after patient consent.
5. We will Randomly assigning the patient to either treatment group or controlled group according to simple random table
6. Prescribing the treatment according to the patient group
7. Follow up of the patient after 1 weak and each week according to the response to treatment or presence of complication

Inclusion criteria:

Children (5 -15) years old with Molluscum contagiosum.

Exclusion criteria:

1. Molluscum contagiosum with Inflamed spot
2. Known immune compromised children
3. Molluscum lesion in the eye lid.
4. Children with renal impairment.

Eligibility Criteria:
Inclusion Criteria:

* Children (2 -16) years old with Molluscum contagiosum.

Exclusion Criteria:

* Molluscum contagiosum with Inflamed spot Known immune compromised children Molluscum lesion in the eye lid. Children with renal impairment.
Damage Control Surgery in the Treatment of Complicated Diverticulitis

To evaluate the use of damage control surgery by performing bowel resection and laparostomy in the treatment of Hinchey III or IV diverticulitis.

Despite the progress in the resuscitation modalities of septic patients, Hartmann procedure (HP) is still considered the safest treatment for generalized peritonitis as a consequence of a complicated acute diverticulitis (stages III and IV of the Hinchey's classification). Almost the half of those patients do not have their stoma reversed because of its association with significant morbidity and mortality. To date, the use of resection with primary anastomosis (PA) is a matter of debate, as it is reported in the literature that it is substantially equivalent to HP in terms of morbidity and length of postoperative stay. For these reason, PA is often reserved for younger patients with few co-morbidities and a lesser degree of peritoneal contamination. In the last decade, Damage Control Surgery has been emerging as a valid alternative to HP and RA in patients presenting a severe sepsis caused by purulent or fecal peritonitis in acute diverticulitis. Initially described for the treatment of major abdominal injuries, indications for DCS have subsequently been extended to septic shock, abdominal compartment syndrome and impossibility to perform a primary closure. However, there is still no consensus about the use of DCS in perforated acute diverticulitis.

The aim of this study was to describe "how-to-use" the Damage Control Surgery in patients with purulent and fecal peritonitis following a severe acute diverticulitis and report the impact on patients' outcomes after the application of this technique in several Italian centers of emergency surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery for Hinchey III and IV stage scheduled for immediate Hartmann's procedure and ICU recovery

Exclusion Criteria:

* None
To Compare the Efficacy of Nor Adrenaline and Terlipressin vs Step up Terlipressin Therapy in Hepatorenal Syndrome

All consecutive patients with liver cirrhosis having Acute Kidney Injury at admission or during hospitalization will be included in the study.

The diagnosis of liver cirrhosis will be based on the clinical grounds including Laboratory tests, endoscopic evidence, imaging (Ultrasonography/computed tomography) findings, and liver histology, when available.


Eligibility Criteria:
Inclusion Criteria:

- Patients with Liver cirrhosis and acute kidney injury. Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria:

- Age less than 18 years Cirrhotics with kidney injury managed as outpatients. Patients undergoing renal replacement therapy (hemodialysis/renal transplantation).

Post liver transplantation patients. Hepatocellular carcinoma. History of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease.

Patients with obstructive uropathy. Patient who withdrew or non complaint to the study protocol.
A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS)

To define the effective dose and tolerability of levetiracetam in individuals with Restless Legs Syndrome (RLS). It is hypothesized that levetiracetam will be well tolerated, safe and effective in treating the symptoms of RLS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with idiopathic RLS according to the four IRLSSG diagnostic criteria

  1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
  2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as sitting or lying down.
  3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues
  4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.

IRLS Rating Scale score greater than 15 at Baseline visit PLM-Index of 5 or greater during the first night of polysomnography Written informed consent obtained prior to any study procedures being performed.

Exclusion Criteria:

1. Women of childbearing potential, who have a positive urine pregnancy test or are lactating as the screening visit, or do not practice a clinically accepted method of contraception.
2. Individuals who are taking medication for Restless Legs Syndrome without a proper washout period
3. Individuals who are taking hypnotics, sedatives, antipsychotics, or neuroleptics
4. History of current diagnosis of other clinically relevant diseases that may confound assessments of RLS symptoms (e.g., Parkinson's disease, dementia, ALS, etc.)
5. Subjects with serum ferritin below 10µg/L
6. Subjects with an untreated sleep disorder that may confound assessments (e.g., narcolepsy, sleep apnea syndrome or other breathing-related sleep disorders, or REM sleep behaviour disorder)
7. Subjects with an apnea/hypopnea index of 15 or greater at the initial polysomnography visit
8. Subjects employed in shift work (e.g., employment hours disruptive to the normal circadian sleep-wake cycle such as nighttime or variable rotating shifts)
9. Subjects who have clinically significant or unstable medical conditions which in the opinion of the investigator would render the subject unsuitable for the study (e.g. severe cardiovascular disease, major depression, psychosis, hepatic or renal failure, etc.)
10. subjects with a positive urine drug test for illicit use of amphetamines, barbiturates, benzodiazepines, opiates, synthetic narcotics, and miscellaneous drugs commonly known as recreational drugs (e.g., cannabinoids including THC, heroine, cocaine)
11. Participation in any clinical drug or device trial in the 30 days prior to the screening visit.
Validation of Chinese SRI Questionnaire

Assessment of health-related quality of life in COPD patients with severe chronic respiratory failure requires appropriate and highly specific measurement tools. We attempt to validate the Chinese version of the Severe Respiratory Insufficiency Questionnaire (SRI)


Eligibility Criteria:
Inclusion Criteria:

1. Adult COPD Patients with chronic hypercapnic respiratory failure established on home noninvasive ventilation for at least 1 month
2. Patients are in a clinically stable state,without any changes of medication during the previous 4 weeks.

Exclusion Criteria:

1. patient's refusal to participate
2. Patients with evidence of acute respiratory failure i.e.patients with worsening of symptoms during the previous 2 weeks, a pH ,7.35, or with signs of respiratory infection
V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)

The study is being conducted to demonstrate that V221 may be administered concomitantly with pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles, mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.


Eligibility Criteria:
Inclusion Criteria:

* In good health
* 12 to 15 months of age
* Negative clinical history to measles, mumps, rubella, varicella and/or zoster
* Received only the 3-dose primary series of a pneumococcal conjugate vaccine with at least 2 months prior to the receipt of any of the study vaccines
* Signed consent

Exclusion Criteria:

* Previous administration of any measles, mumps, rubella, or varicella vaccine either alone or in any combination
* Any condition resulting in depressed immunity
* Any allergy to any vaccine component as stated in the package circulars
* Exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
* History of seizure disorder
* Receipt of an inactivated vaccine within 14 days prior to enrollment or live vaccine within 30 days
* Recent febrile illness