cyrilzakka/clinical-trials huggingface dataset:
Presurgical Therapy With Lapatinib to Explore Molecular Determinants of Response to EGFR/erbB2 Targeted Therapy

The purpose of this study is to see what kinds of breast tumors will respond to lapatinib. Lapatinib is an experimental medicine which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically-confirmed by either core or fine needle biopsy primary invasive carcinoma of the breast;
* AJCC T2-T3 disease (\>2.0 cm without chest wall or skin invasion) by at least one imaging modality (either mammogram, ultrasound, or MRI) - entry criteria is based on radiologic staging and not final pathologic staging;
* ECOG performance status 0-1 (Karnofsky ≥ 70%
* Any lymph node status, hormone receptor status, and level of erbB2 expression
* No prior chemotherapy, hormonal therapy or radiation therapy to the affected breast for current or previous malignancy;
* Cardiac ejection fraction \>50% or within the institutional range of normal;
* Patients must have normal organ and marrow function defined as: Leukocyte count \>3000/uL; Absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets \> 100,000/mm3, and hemoglobin ≥ 8 gm/dl; Serum creatinine ≤ 1.5 times ULN, or 24-hour creatinine clearance ≥ 75 cc/min; Serum bilirubin ≤ 1.5 times ULN; SGOT ≤ 2.5 times ULN; alkaline phosphatase ≤ 2.5 ULN times ULN.
* The effects of lapatinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Ability to understand and the willingness to sign written informed consent document.

Exclusion Criteria:

* AJCC T1, T4, or stage 4 disease;
* Patients may not have undergone incisional or excisional biopsy of their tumor;
* Patients may not be receiving any other investigational agents;
* Absolute contraindication to MRI imaging (cardiac pacemaker or any non-removable metallic foreign object in the body);
* On chronic therapy with any known inducer or inhibitor of CYP3A4
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant or lactating women are excluded from this study because lapatinib is a tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects.
Health Care Seeking Behavior and Knowledge Assessment of Hungarian Women About Pelvic Floor Disorders

The aim of this study is to assess women's health care seeking behavior and knowledge of urinary incontinence and pelvic organ prolapse and to culturally adapt the Prolapse and Incontinence Knowledge Questionnaire (PIKQ) for the Hungarian population.


Eligibility Criteria:
Inclusion Criteria:

* Woman
* Age 18 and above
* Ability to read and write Hungarian
* Willing to complete the online survey
* Providing consent to participate

Exclusion Criteria:

* Respondents who had already completed the questionnaire on a prior occasion
* Respondents who unable to complete the online survey due to illiteracy
Prognosis in Subacute Ischemic Stroke Using Multimodal Imaging

We enrolled patients with subacute IS, associated with moderate-to-severe stenosis of the unilateral cervical internal carotid artery, who underwent 4D ASL. Perfusion levels and collateral circulation were compared between groups with favorable prognosis (modified Rankin scale \[mRS\] ≤ 2) and poor prognosis (mRS \> 2).


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed unilateral internal carotid artery/MCA atherosclerotic stenosis/occlusion with a stenosis degree \> 50% verified through computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
2. Presence of IS or transient ischemic attack (TIA) symptoms in the circulating blood supply area within the preceding 48 h.
3. Asymptomatic patients with no history of IS or TIA in the past 6 months.
4. Performance of 4D ASL tests during hospitalization.

Exclusion Criteria:

1. Moderate-to-severe stenosis/occlusion of the contralateral internal carotid artery/middle cerebral arteries.
2. Age ≤ 18 years old.
3. Cardioembolic cerebral infarction.
4. Moyamoya disease.
5. Combined or previous cerebral hemorrhage or subarachnoid hemorrhage
6. History of previous cerebral infarction.
7. Claustrophobia or the presence of intracranial metal implants, cochlear implants, or pacemakers.
Mid-point to Pleura Transverse Process Block Versus Thoracic Intervertebral Foramen Block

The analgesic effect of continuous mid-point to pleura transverse process block compared to the analgesic effect of continuous thoracic intervertebral foramen block, in patients with multiple rib fractures.

The analgesic effect of continuous mid-point to pleura transverse process block will be compared to the analgesic effect of continuous thoracic intervertebral foramen block, in patients with multiple rib fractures, by using the numeric rating scale (NRS) for pain.

Eligibility Criteria:
Inclusion Criteria:

* ribs fracture after polytrauma

Exclusion Criteria:

* pregnancy
* allergy to anesthetics
* head trauma
* history of neurological impairment (primary or secondary)
* history of cancer
* history of chronic obstructive pulmonary disease
* infections of skin close to the block site
* systemic infections
A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis

This was a multicenter, open-label, randomized, crossover trial in subjects with MS who were already taking a stable dose of baclofen (up to 80 mg/day) for spasticity. The trial was designed to assess subject preference for Kemstro or conventional baclofen. At Visit 1, subjects were screened, and if qualified, were randomly assigned to one of two following treatment sequences: Kemstro/conventional baclofen or conventional baclofen/Kemstro.


Eligibility Criteria:
Inclusion Criteria:

* stable dose of baclofen

Exclusion Criteria:

* not stable dosing
A Sleep Intervention for Cancer Patients and Their Caregivers

The purpose of the study is to design and test a dyadic sleep intervention for patients diagnosed with cancer and their intimate partner.

Sleep problems remain underdiagnosed and undertreated among cancer patients despite their high prevalence and consequences to quality of life and health. Hepatobiliary cancer patients have one of the highest rates of sleep problems with 59% reporting poor sleep quality and 43% reporting sleeping less than 6 hours per night. Sleep problems were found to be associated with clinical levels of depressive symptoms, elevations in pain and fatigue. Investigators have observed that short sleep duration was associated with increased risk of mortality in patients with hepatobiliary cancers. Inflammation has been hypothesized to mediate the link between sleep and mortality. In hepatobiliary cancer, short sleep duration was associated with elevations in Interleukin (IL)-6, IL-1, IL-1 and IL-2 and poor sleep quality with elevations in Interferon (IFN) Interleukin-2, after adjusting for tumor associated inflammation, mediated the link between sleep duration and survival. These pro-inflammatory cytokines are also related to tumor growth and development of metastases. Sleep problems of spouses or intimate partners of hepatobiliary cancer patients were also prevalent with 62% reporting poor sleep quality and 33% reporting sleep less than 6 hours per night. Caregiving for an intimate partner with cancer has been linked to increased mortality and sleep has been proposed as a possible mediator of this link. Face to face cognitive behavioral therapy (CBT) has been shown to be effective in cancer patients and cancer caregivers. However, due to the distance patients travel to our medical center (58% \>1 hour), infrequency of visits (e.g., approximately every two months), limited resources (48% of patients \<$20,000 annual income), and the unpredictability of cancer-related symptoms; weekly face-to- face CBT to treat sleep problems is not feasible. Therefore, investigators will test a dyadic Modified Cognitive Behavioral Therapy for Insomnia (CBTi) intervention to reduce insomnia in patients and possibly caregivers and expect the findings of this study to have a significant public health impact for the over 12 million cancer patients and spousal/partner caregivers in which nearly half are estimated to suffer from sleep problems.

Eligibility Criteria:
Inclusion Criteria:

Patient

* Diagnosed with cancer
* Screens positive for sleep problems (5 or greater score on the PSQI)
* Shares a bed with the caregiver/intimate partner
* Patient's caregiver/intimate partner also screens positive for sleep problems (5 or greater score on the PSQI)

Exclusion Criteria:

Patient or Caregiver

* does not screen positive for sleep problems
* has been diagnosed with sleep apnea or use a continuous positive airway pressure (CPAP) machine
* has been diagnosed with narcolepsy or restless legs
* works in a job that requires shift changes
* does not speak/read English
* does not share a bed with intimate partner
Comparative Study About the Impact of Two Oil Emulsions Administered Intravenously on Severe Acute Pancreatitis

The purpose of this study is to comparatively assess the potential antiinflammatory effects of intravenous lipid emulsions rich in omega 3 polyunsaturated fatty acids and olive oil versus intravenous lipid emulsions made exclusively with MCT and LCT on the evolution of patients with severe acute pancreatitis during the period in needing artificial nutrition support with total parenteral nutrition so unique.

Information recorded in other data elements.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute pancreatitis: characteristic abdominal pain, serum amylase and / or lipase \>= 3 times the upper limit of normal range, characteristic CT-scan
* Criteria of severity of acute pancreatitis diagnosed at \<= 72 hours following admission: severity Index of Balthazar's CT-scan (with contrast) \>= grade D, APACHE-II \>= 8, C-reactive protein \>= 150 mg/L
* Inability to initiate feeding (oral or with nutritional supplements) and / or enteral nutrition during the 5 days after the diagnosis and prediction of the indication of nil-by-mouth \>= 5 days
* \<= 3 mmol/L of triglycerides in the blood
* Men and women aged \>= 18 years old
* Acceptance of informed consent

Exclusion Criteria:

* Known hipersensitivity to the fish, egg or soy proteins
* Lipid etiology
* \> 3 mmol/L of triglycerides in the blood
* Severe hepatic impairment
* Severe renal insufficiency without dialysis or haemofiltration
* Serious disturbances of blood clotting
* Acute shock
* Infusion therapy general contraindications
* Clinical conditions of instability that must not be taken with parenteral nutrition
* Have other acute or chronic inflammatory diseases
* Status of severe immunosuppression: cytotoxic treatment in 15 days prior to inclusion and / or a disease that causes white blood cells levels \<5000/mm3
* Treatment with steroids \> 0.25 mg/kg/day of prednisone or equivalent doses of corticosteroids: as pre-treatment and / or during admission
To Compare the Efficacy of Endoscopic Ultrasound Assisted Endoscopic Glue Injection and Conventional Endoscopic Injection Therapy for Prevention of Gastric Variceal Rebleed

Consecutive patients who meet the eligibility criteria will be enrolled into the study. All patients with gastric varices with no history of gastric variceal bleed (Group C) will undergo Endoscopic ultrasound and Upper Gastrointestinal Endoscopy at baseline, at the end of first year and at the end of study.

The patients who presented to Institute of Liver and Biliary Sciences with gastric variceal bleed or develop Gastric Variceal bleed during hospital stay will be randomized into Group -A (conventional Upper Gastrointestinal Endoscopy + Glue) and Group-B (Endoscopic Ultrasound followed by Upper Gastrointestinal Endoscopy+Glue) therapy for gastric varices. Total 90 patients will be enrolled and randomized into group A and Group B after resuscitation and urgent Upper Gastrointestinal Endoscopy with standard therapy for bleeding gastric varices to achieve hemostasis.


Eligibility Criteria:
Inclusion Criteria:

* A clinical, radiological or histologic diagnosis of cirrhosis
* Upper Gastrointestinal endoscopy showing gastric varices
* Informed consent to participate in the study

Exclusion Criteria:

* Previous endotherapy (Endoscopic Variceal Ligation/Esophageal Variceal Sclerotherapy/Endoscopic Variceal Obliteration) for gastric variceal haemorrhage
* Diagnosed case of HepatoPulmonary Syndrome.
* Non -cirrhotic portal hypertension/Extra hepatic Portal Venous Obstruction
* transhepatic intrajugular portosystemic shunt, (balloon-occluded retrograde transvenous obliteration), balloon-occluded endoscopic injection sclerotherapy, shunt operation.
* Hepatic encephalopathy grade III/IV,
* Cardio respiratory failure
* Pregnancy
2177GCCC:ID'Ing tx Targets and Biomarkers for Ocular Surface Disease in Pt w/ oGVHD

Evaluate and study the immunologic changes to the ocular surface in cancer patients.

This is a longitudinal natural history study to evaluate and study the immunologic changes to the ocular surface in cancer patients.

Two groups of subjects will be recruited for the study: 1) Pre-bone marrow transplant cancer patients. They will be evaluated every 3 months for 2 years.2) Normal control patients. They will be evaluated every 6 months for the duration of the study.

During each study visit, in addition to standard of care exams, certain biological specimens ( ocular surface wash, mucocellular material, corneal filaments, or impression cytology of conjunctiva, blood, or serum) will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years of age) who visit the Eye clinic either in the UMGCCC within the UMD Hospital or the UMD Faculty Physicians Ophthalmology Practice at the UMD Professional Building or satellite locations for initial visits or established visits.
* The patient must be able to understand and sign and date the informed consent form approved by the IRB.

Exclusion Criteria:

* Vulnerable populations: neonates, children, prisoners, institutionalized individuals.
* Inability or refusal to provide informed consent.
* History of ocular surgery (except refractive surgery or cataract surgery)
Psychosocial Situation of Children With Rare (Congenital) Pediatric Surgical Diseases and Their Families

Families of children with rare diseases (i.e., not more than 5 out of 10.000 people are affected) are often highly burdened with fears, insecurities and concerns regarding the affected child and his/her siblings. The aim of the present research project is to examine the psychosocial burden of the children with rare (congenital) pediatric surgical diseases and their family in order to draw attention to a possible psychosocial care gap in this population.

The central objective of the cross-sectional study is to show the psychosocial supply gap for families with children and adolescents affected by rare diseases in the field of pediatric surgery. Among the rare diseases that are included are diaphragmatic hernia, anorectal malformations, esophageal atresia, Hirschsprung's disease and biliary atresia. In order to have a comparative sample, additional data of a matched control group are collected. Central standardized psychosocial outcomes will be assessed from the perspectives of the parents, the affected child and the siblings.

Eligibility Criteria:
Inclusion Criteria (families of rare disease):

* Family with at least one child between 0 and 21 years with a rare pediatric surgical disease.
* Consent to participate in the study.
* Sufficient knowledge of the German language of parents and children.

Exclusion Criteria (families of rare disease):

* Severe acute physical, mental and/or cognitive impairment of the child, so that the questionnaire survey does not appear possible and/or unreasonable at this stage.

Inclusion Criteria (control group):

* Family with at least one child between 0 and 21 years who have undergone a surgical procedure in the first 3 years of life that does not cause chronic complaints
* Consent to participate in the study.
* Sufficient knowledge of the German language of parents and children.

Exclusion Criteria (control group):

- Families of children with a congenital or chronic disease.
Effect of NPO Time and Type of Food Intake on Preoperative Residual Gastric Content and pH

According to normal physiology, the longer fasting period allows food particles to pass stomach through small intestines to minimize intragastric content. The practice guidelines recommend 2-hour fasting period for clear fluid (including water, pulp-free juice and tea or coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for non-human milk and solid food to reduce risks of pulmonary aspiration. As a result of longer fasting period, patients tend to experience preoperative dehydrated states and intraoperative hypotension. Patients' demographic data will be obtained from charts. Parents will be asked for type, volume of fluid/food intake and NPO time.

This study will be done at BCH's Gastroenterology Procedure Unit (GPU) theaters to measure actual intragastric volume and pH at the beginning esopagogastroduodenoscopy procedures. We hope to demonstrate the relationship between NPO time and actual intragastric volume which provide sufficient data of NPO time to ensure patient's safety.

This study is a prospective observational cohort study which will be conducted in 2 parts including preoperative and intraoperative periods.

* Preoperative period, patients' demographic information will be collected along with NPO history including times, type ,amount of preoperative fluid/ food intake and patients' anxiety score.
* Intraoperatively, at the beginning of EGD procedure, total volume of intragastric content(ml) and gastric acidity will be measured.

We plan to offer participation to all patients or parents of patients' ages 0-17 years who are scheduled for EGD at GPU, BCH Longwood campus and are fluent in English. A brochure describing our study in English will be given to patients or their families on the day of surgery. If the patient or family agrees to participate in this study, the study will be provided in the GPU theaters.

Eligibility Criteria:
Inclusion Criteria:

- All patients who aged 0-17 years scheduled for EGD procedure.

Exclusion Criteria:

- Patients who required emergency EGD procedures and patients with active upper GI bleeding.
Enterprise Stent Aneurysm Treatment (ESAT) Study - France

The purpose of this study is to evaluate the morbidity, mortality, and efficacy of use of the Enterprise(TM) stent for the treatment of (ruptured or non-ruptured) intracranial aneurysms.

Per the opinion of the Commission for the Evaluation of Products and Services (CEPP) in France, renewal is contingent upon setup of a prospective morbidity, mortality, and efficacy study. The objective is to follow the stented Subjects for at least 1 year and evaluate the device and practices.

This will be a multicenter study involving up to 15 interventional neuroradiologists in France. Subjects presenting with ruptured or non-ruptured aneurysms for whom simple or balloon assisted endovascular treatment is considered impossible or insufficient by the interventional neuroradiologist.

Eligibility Criteria:
Inclusion Criteria:

* Patient implanted with one or more CODMAN ENTERPRISE™ stents and who present one or more ruptured or non-ruptured intracranial aneurysms assessed by angiography
* Agreement to take part in the study by the patient, or a representative of the patient in case of patient inability, after being informed by the investigator and have received information letter.

Exclusion Criteria:

* Minors \<18 years of age
* Patient implanted for the same aneurysm with a CODMAN ENTERPRISE™ stent in association with one or more stents from a different brand.
* Patient who does not accept to take part in the study.
Presence and Relapse Rates in Patients with Alcohol Use Disorder Using Virtual Reality

Investigation of the influence of the sense of presence during a Virtual Reality Cue-Exposure Therapy (VR-CET) with alcohol-associated cues on craving and relapse rates.

Study group: abstinent patients (at least 18 years old) with a diagnosed alcohol dependence after completed inpatient withdrawal treatment in the the last 3 months.

Primary hypothesis: the experience of presence during a virtual presentation of alcohol in alcohol-dependent patients is associated with levels of craving for alcohol during VR-CET.


Eligibility Criteria:
Inclusion Criteria:

* age: 18-65 years
* diagnosis of alcohol dependence according to ICD-10 (F10.2)
* completed in-patient withdrawal treatment during the last 3 months
* history of alcohol craving, confrmed via craving questionnaires
* able to provide written informed consent

Exclusion Criteria:

* substance dependence other than alcohol and nicotine
* current alcohol intoxication (randomly tested via measurement of breath alcohol concentration)
* unable to understand the study information, consent form or principles of the study
* abstinence for less than 7 days or on-going consumption of alcohol
* severe neuropsychiatric disorder, e.g., schizophrenia spectrum disorders, bipolar afective disorder or substantial cognitive impairment
* somatic diseases for which VR is associated with risks, e.g. photosensitive epilepsy
* acute suicidality or acute endangerment of others
* concurrent pharmacological treatment targeting AUD (i.e. benzodiazepines) or craving (i.e. acamprosate, disulfram, naltrexone, nalmefene)
Effect of the Reflexology on Insomnia Severity Index in Hypertensive Patients

In Egypt, there is a dearth of understanding of the benefits of reflexology and aerobic exercise on hypertension patients' quality of life.

The participated subjects were enrolled based on the inclusion and exclusion criteria , In this study, forty hypertensive female patients between 35 and 45 were divided to two equal groups (A and B). Twenty female patients in group (A) got medications and peddling training, while twenty female patients in group (B) had the exact treatment as group (A) as well as reflexology. Insomina severity index and a short form 36 quality of life questionnaire were used to assess the patients who took part in the study (ISI). They were assessed before and after the eight-week treatment program, which consisted of three sessions each week; following four weeks of treatment (post-1) and additional four weeks of treatment (post-2) the post evaluation was used (post-2).

Eligibility Criteria:
Inclusion Criteria:

1. Forty hypertensive patients aged 35 to 45 years of both sexes (men and women).
2. Clinical and medically, all of the participants were in good health.
3. The BMI ranged from 30 to 34.9 kg/m2 for all participants.

Exclusion Criteria:

1. Close Myocardial infarcts.
2. Heart block or complex ventricular arrhythmia
3. Cerebrovascular disease is a condition in which the blood vessels in the brain become inflamed.
4. Defects in vision or hearing.
5. Significant tightness in the lower limbs and/or a fixed deformity of lower limbs.
6. Balance or mentality-related neurological diseases (e.g. epilepsy).
7. Abnormalities of lower limb that may be congenital or acquired.