cyrilzakka/clinical-trials huggingface dataset:
A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors

The purpose of this study is to find out what effects (good and bad) CyberKnife stereotactic radiosurgery has on tumors near the critical structures of the eye (optic apparatus).

The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife ® can deliver tumor ablating doses of radiation to perioptic lesions safely and effectively while sparing the adjacent optic apparatus and normal brain tissues from receiving damaging doses of radiation.

The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.

Eligibility Criteria:
Inclusion Criteria:

* Perioptic lesion within 2mm of the optic apparatus
* Age \>= 21
* KPS \>= 50
* Planning Target Volume (PTV) \<= 6.0 cm in maximal diameter

Exclusion Criteria:

* Malignant histology
* Age \< 21
* KPS \<= 40
* Planning Target Volume (PTV) \> 6.0 cm in maximal diameter
* Prior whole brain XRT
* Gross total resection
Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms

Mechanical thrombectomy(MT) has been recommended in patients with acute large vessel occlusion stroke(LVO) , especially for those with National Institutes of Health Stroke Scale (NIHSS) score ≥6. However, it is still unclear if patients with minor strokes and LVO also benefit from MT.The aim of this study was to evaluate the safety and efficacy of MT for acute LVO and mild symptoms.

This is a prospective cohort study of patients with with mild ischemic stroke (NIHSS Score \<6) and LVO. Patients were divided into 2 groups: MT or medical management.Baseline data and clinical outcomes were compared. A independent clinical outcome was defined as a modified Rankin Scale score of 0 to 2 at 90 days. A excellent clinical outcome was defined as a modified Rankin Scale score of 0 to 1 at 90 days. Symptomatic intracranial hemorrhage(sICH) was the safety outcome.

Eligibility Criteria:
Inclusion Criteria:

1. acute ischemic stroke within 24 hours of symptom onset presenting cortical symptoms (such as aphasia, somnolence,slow-minded,etc.) or vertigo with bilateral pathological signs;
2. age≥18 years old;
3. the NIHSS score before evaluation of thrombectomy\<6;
4. large artery occlusion including Middle cerebral artery M1, proximal M2 segment, intracranial internal carotid artery and infarct core volume≤50ml and mismatch ratio\>1.8 or basilar artery and posterior cerebral artery P1 occlusion

Exclusion Criteria:

1. Patients without prior functional independence (mRS score of \>2)
2. Patients in intervention group with occlusive artery spontaneous recanalization in digital subtraction angiography
3. patients in control group with neurological worsening and received rescue thrombectomy
Evaluation of the Basic Assessment of Severity of Illness in Children (BASIC) Scale

The purpose of this study is to assess whether the BASIC Scale--a simple, non-invasive clinical triage protocol--predicts severe illness, hospitalization or death among children under age five presenting for acute care in a rural African health center.


Eligibility Criteria:
Inclusion Criteria:

* Child aged two months to five years presenting routine or urgent care in an ambulatory facility

Exclusion Criteria:

* None
Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants

The purpose of this study is to understand the speech perception in noise and in quiet and localization benefits in a laboratory setting in listeners that receive a cochlear implant in an ear with severe to profound hearing loss and have normal, or near-normal hearing in the opposite ear. We will also evaluate the functional benefit of restoring hearing to the impaired ear via questionnaires that subjects will be answering while listening in their natural environment.


Eligibility Criteria:
Inclusion Criteria:

1. Participants will be adults who utilize English as their primary language.
2. Unilateral severe to profound sensorineural hearing loss for a duration of at least 6 months (to ensure stability of hearing loss), but no greater than 10 years.
3. Contralateral ear with normal, or near-normal, hearing.
4. Poorer ear (ear to be implanted): severe to profound sensorineural hearing loss, defined as pure-tone thresholds 70 dB HL or greater for the frequencies 500, 1000, 2000, 3000, and 4000 Hz with monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, less than or equal to 20%
5. Better ear (contralateral ear): normal or near-normal hearing defined as pure-tone thresholds no poorer than 30 dB HL at 250, 500, 1000, 2000, and 3000 Hz and no poorer than 40 dB HL at 4000 Hz with monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, of greater than or equal to 85%.
6. Willingness to comply with all study requirements.
7. Patent cochlea and normal cochlear anatomy.

Exclusion Criteria:

1. Medical or psychological conditions that contraindicate undergoing surgery.
2. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
3. Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
4. Unwillingness or inability of the candidate to comply with all investigational requirements.
5. Active middle ear infection.
6. Tinnitus primary motivation for implantation.
Placental Transfer of Tenofovir

The purposes of this study are to determine whether transporters expression levels and drug interaction between TDF and FTC could contribute to modulate the placental transfer of this drug or. To test this hypothesis, an ex vivo model known as "the perfused ex vivo cotyledon model" allows to reproduce the conditions of the third trimester of pregnancy

Nowadays, mother-to-child HIV transmission is the main cause of paediatric HIV infections. Yet, this way of transmission is effectively limited by the use of antiretroviral therapies during pregnancy in HIV infected women. The study TEmAA (ANRS 12109) we conducted allowed us to suggest a therapeutic scheme of administration of the association tenofovir disoproxil fumarate (TDF) - emtricitabine (FTC) to reduce the risk of postpartum resistance that may occur with the administration of a single dose of nevirapine before delivery. However, we also observed a large interindividual variability of TDF in vivo placental transfer that remained unexplained. Placental membrane transporters, including efflux transporters belonging the ABC transporter superfamily and uptake transporters, may constitute a source of variability. In this case, we showed such an association for maraviroc with a significant inverse correlation between its clearance index and the placental expression level of several efflux transporters of the ABCC/MRP family. Regarding TDF, it has been shown that this drug is a substrate of several efflux transporters (ABCC2/MRP2, ABCC4/MRP4, ABCC10/MRP7) and an uptake transporter (hOAT3). As these transporters are expressed on the placental barrier, it may be hypothesized that their expression levels could contribute to modulate the placental transfer of this drug. To test this hypothesis, an ex vivo model known as "the perfused ex vivo cotyledon model" allows to reproduce the conditions of the third trimester of pregnancy. Our first aim is to evaluate the potential effect of ABCC2, ABCC4, ABCC10 and hOAT3 placental expression on TDF placental transfer (First year). We also want to investigate whether a potential interaction between TDF and FTC could take part to variability.

Eligibility Criteria:
Inclusion Criteria:

* Major Patients \> or = 18 years old
* At term between 37 and 41 weeks of gestational age
* Uncomplicated pregnancy
* Informed Consent Form signed

Exclusion Criteria:

* Women HIV+, HBV+ or HBC+
* Women with cardiovascular diseases such as diabetes or preeclampsia, IUGR
* Women who had taken medications during pregnancy
Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise on Body Posture

This study; It will be done in order to show evidence of the effects of pelvic floor muscle training and diaphragmatic breathing exercise via telerehabilitation on body posture and quality of life in healthy individuals. International Physical Activity Quastionnaire Short Form (IPAQ), Pelvic Floor Impact Quastionnaire Short Form (PFIQ-7), 36-Item Short Form Survey(SF-36) and New York Posture Rating Chart will be applied.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 18-25
* Being a woman over the age of 18

Exclusion Criteria:

* obstructive or restrictive lung disease
* diagnosed with urinary incontinence or pelvic organ prolapse
* pelvic pain
* history of pelvic surgery
* Any history of spinal, thoracic or abdominal surgery
* To smoke
* cardiac, neurological and rheumatological disease
* Congenital deformity or previous history of surgery in the spine and thorax
* endocrine and metabolic disease
* psychiatric disorders
* cardiological disorders
* malignancy
* Doing regular physical activity or sports for the last 3 months
Neonatal Seizures in NICU of Assuit University Children's Hospital

A cross sectional study on neonatal seizures in Assuit University Children's hospital NICU.

An Overview on neonatal seizures in neonatal intensive care unit of Assuit University Children's hospital , a cross sectional study. The aim of this study is to evaluate the clinical seizures during the neonatal period and its prevalence

Eligibility Criteria:
Inclusion Criteria:

* ALL neonates (preterm and full-term infants) aged 0 to 28 days who are admitted to the neonatal intensive care unit of Assiut University Children's hospital during the period of the study will be included

Exclusion Criteria:

* Neonates with multiple congenital anomalies (other than CNS anomalies)
BKM120 as Second-line Therapy for Advanced Endometrial Cancer

This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.


Eligibility Criteria:
Inclusion Criteria:

* ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
* histologically confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen for identification of PI3K pathway activation (archival tissue or a fixed fresh biopsy)
* one prior line of antineoplastic treatment with a cytotoxic agent
* objective progression of disease after prior treatment and at least one measurable lesion as per RECIST criteria
* adequate bone marrow and organ function

Exclusion Criteria:

* previous treatment with PI3K and/or mTOR inhibitors
* symptomatic CNS metastases
* concurrent malignancy or malignancy within 3 years of study enrollment
* Active mood disorder as judged by investigator or medically documented history of mood disorder (e.g. major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, etc.), ≥ CTCAE grade 3 anxiety
* pelvic and/or para-aortic radiotherapy ≤ 28 days prior to enrollment in the study
* poorly controlled diabetes mellitus (HbA1c \> 8 %)
* history of cardiac dysfunction or active cardiac disease as specified in the protocol
* impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120

Other protocol-defined inclusion/exclusion criteria may apply
The Effect of Oxygen Administration on Regional Cerebral Oxygen Saturation (rSO2) in the Non-block Side After Stellate Ganglion Block

Stellate ganglion block (SGB) is known to increase blood flow to the innervation area of the stellate ganglion. Near infrared spectroscopy reflects changes of blood volume and allows continuous, non-invasive, and bedside monitoring of regional cerebral oxygen saturation (rSO2). Previous studies have shown the increment of the rSO2 on the block side from the baseline and the decrement of the rSO2 on the non-block side after SGB. Patients with cerebral vascular disease undergoing SGB might be at risk a decrease in cerebral blood flow in the non-block side. The investigators researched the effect of oxygen administration on rSO2 in the non-block side using a near infrared spectroscopy after SGB. 5 L/min oxygen was supplied via nasal cannula from 15 minutes after SGB. The rSO2 in the non-block side were measured before SGB and 5, 10, 15, 20, 25 and 30 minutes after SGB.

The present study suggests that oxygen administration can increase the rSO2 of non-block side. In conclusion, it is our belief that oxygen supplement is helpful to the patient with cerebral vascular disease during SGB.


Eligibility Criteria:
Inclusion Criteria:

* ages between 20 and 70 years
* ASA PS 1,2
* disease entity : pain in the head, neck, upper extremity, and SSNHL ( sudden sensory neural hearing loss )

Exclusion Criteria:

* patient with the tendency to bleed
* patient who had cerebrovascular disease
* patient with respiratory disease ( COPD: chronic obstructive lung disease )
* patients who do not give written informed consent to participate in the study
Abdominal Massage With TENS on Parasacral Versus Sacral Area on Symptom,Severity & QOL in Chronic Constipation Females.

Constipation is Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. Patients complaining of constipation may mean different things by the term The frequency of their bowel actions may be less than 'normal', their stools maybe difficult to pass, or they may have a sense of malaise or abdominal discomfort which they attribute to a 'sluggish bowel', though the stool frequency and consistency are apparently normal. Objective of this study is to compare effects of Abdominal massage. withTENSonparasacralversussacralareaonsymptomseverityandqualityoflifein severechronicconstipationamongyoungfemales.

This study will be a Randomized Clinical trial and will be conducted at services Hospital in Lahore. The study will be completed with in the time duration of eight months. Purposive sampling technique will be used to collect the data. A sample size of Total 24 patients will be taken in this study. Patients will be divided into two groups.(Group A will be treated with TENS on sacral area and abdominal massage where as Group B will be treated with TENS on par sacral area and abdominal massage).PAC-SYM Questionaire,PAC-QOL Questionaire will be used to ask some questions related to patients 'symptoms and abdominal cramps or bloating.. All participants of the study will fill the PAC-SYMQ and PAC-QOL Q on day 1 as pre treatment values and at the end of 4th session as post treatment values respectively. The collected data will be analyzed on SPSS-25.

Keywords : constipation, Quality of life , abdominal massage.

Eligibility Criteria:
Inclusion Criteria:

* Age between 14 -35year
* Only females
* Laxatives at least once or more for 2weeks
* Non pregnant
* Chronic Constipation more then 6 months

Exclusion Criteria:

* Organic dysphasia or secondary constipation caused by laxatives for unrelated conditions.
* Pregnant females suspected pregnant subjects, as well as those who were breast-feeding
* Non co-operative patients
* Female with underlying disease
Cell Surface Marker Expression in Autoimmune Diseases

This study is designed to explore the expression of cell-surface markers in the following seven disease areas: (a) systemic lupus erythematosus, (b) Sjogren's syndrome, (c) multiple sclerosis, (d) systemic sclerosis, (e) Crohn's disease, (f) ulcerative colitis and (g) inflammatory myositis.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants 19 years of age or older.
2. Participant or legal surrogate able and willing to provide written, informed consent.
3. Participant is, or has been undergoing care for one of the specified diseases in a participating centre with a confirmed clinical diagnosis of the specified disease.
4. Participant has or will provide the relevant peripheral blood (required) and normal practice tissue specimens (if available).
5. Participant has one of the following target auto-immune or inflammatory diseases diagnosed according to local clinical practice guidelines:

   1. Crohn's Disease
   2. Inflammatory myositis
   3. Multiple sclerosis
   4. Sjogren's syndrome
   5. Systemic lupus erythematosus
   6. Systemic sclerosis
   7. Ulcerative colitis

Exclusion Criteria:

1. Participants receiving investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to enrolment.
2. Participants suffering from any additional disease that may interfere with the biomarker signals as per the investigator's discretion.
A Clinical Trial to Explore the Safety and Efficacy of Three Different Doses of Pegaptanib Sodium in Patients With Wet Age-Related Macular Degeneration (AMD)

The purpose of this trial is to compare the ability of three different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or improving vision in patients with wet AMD. The study will also examine the effects of pegaptanib sodium on the cornea and sensory retina of patients with wet AMD.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender, aged 50 years or greater.
* Subfoveal choroidal neovascularization (CNV) due to AMD.
* Best corrected visual acuity in the study eye between 20/40 and 20/320.
* Normal electroretinogram, and corneal endothelial cell density of 1500 cells/mm2 or more.

Exclusion Criteria:

* Any prior photodynamic therapy (PDT) with Visudyne or thermal laser to the study eye.
The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up

The purpose of the Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery (PALACS, NCT02875405) trial was to determine if performing posterior left pericardiotomy at the time of cardiac surgery prevents atrial fibrillation after cardiac surgery. The purpose of the Posterior left pericardiotomy for the prevention of AtriaL fibrillation After Cardiac Surgery-Extended Follow-Up (PALACS-EF) study is to evaluate the effect of posterior left pericardiotomy on 5-year clinical outcomes.

Post-operative atrial fibrillation (POAF) is a common complication of cardiac surgery which is observed in 30-40% of patients. POAF has also been associated with stroke, systemic embolism or cardiac failure during the years after surgery. Several strategies aimed at reducing the incidence of POAF have been investigated, including beta-blockers, amiodarone, and statins, with unsatisfactory results. In the randomized prospective clinical trial, the PALACS trial, 420 patients were randomized either to the intervention group, which received left posterior pericardiotomy at time of cardiac surgery, or to the control group, which did not receive posterior left pericardiotomy at time of cardiac surgery. Posterior left pericardiotomy was associated with a reduction in the incidence of POAF after surgery, but not with improvement in 30-day patient outcomes.

This non-interventional, prospective study is an extension follow-up study (PALACS-EF) of all patients who were enrolled in the original PALACS trial. It is designed to evaluate differences in clinical outcomes between patients who received posterior left pericardiotomy (intervention) versus those who did not (control) at median follow-up of 5 years.

Eligibility Criteria:
Inclusion Criteria:

* This study will include all the subjects enrolled in the PALACS trial

Exclusion Criteria:

* Not enrolled in the PALACS trial
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have head and neck cancer.

OBJECTIVES: I. Determine the toxicity of fluorouracil and cisplatin with concurrent radiotherapy in patients with stage I-IVB squamous cell cancer of the head and neck at high risk of recurrence following curative resection. II. Determine the efficacy of this regimen in these patients. III. Determine the survival of these patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive fluorouracil IV continuously on days 1-5 and 43-47 and cisplatin IV over 1 hour on days 2, 23, and 44. Concurrent radiotherapy is administered 5 days a week for 6.5 weeks. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 44-68 patients will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven stage I-IVB squamous cell cancer of the oral cavity, oropharynx, hypopharynx, or larynx Positive lymph nodes allowed, either bilateral or contralateral Curatively resected within past 6 weeks No distant metastases

PATIENT CHARACTERISTICS: Age: Over 18 to 70 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 2,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and SGPT less than 2 times ULN Alkaline phosphatase less than 2 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 70 mL/min Cardiovascular: No contraindication to fluorouracil IV No coronary artery disease greater than grade 2 No unstable heart disease Other: No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent adjuvant therapy No concurrent preventive treatment (e.g., retinoids) No other concurrent experimental treatment