cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage

The purpose of this study is to examine wether delayed cerebral ischemia can be predicted by ultrasound brain perfusion imaging in patients with aneurysmal subarachnoid hemorrhage (SAH).

The delayed cerebral ischemia is a main complication in patient with aneurysmal subarachnoid hemorrhage which causes neurological deficit. So far there is no reliable diagnostic tool to predict the appearance of cerebral ischemia.

The causal correlation between presence of cerebral vasospasm measured daily by transcranial Doppler sonography (TCD) and occurrence of cerebral ischemia detected by cranial computed tomography scan (CCT) is not finally verified.

First studies demonstrated that ultrasound perfusion imaging (UPI) allows the detection of perfusion deficits in middle cerebral artery infarction.

The purpose of our study is to evaluate the diagnostic and prognostic value of UPI to predict delayed cerebral ischemia. In our trial we compare parameters of UPI (b= rise rate, A= plateau of acoustic intensity) in patients with aneurysmal subarachnoid hemorrhage with results of follow-up cranial computed tomography scans (CCT), TCD results and clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Aneurysmal subarachnoid hemorrhage, Hunt and Hess 0-5
* Informed consent
* Sufficient transtemporal acoustic window
* First examination within 48h after subarachnoid hemorrhage
* Minimum Age 18 years

Exclusion Criteria:

* Contraindication against computed tomographic scan
* Incompatibility against SonoVue™
* Acute respiratory distress syndrome
* Uncontrollable hypertensive crisis
* Severe pulmonary disease(pulmonary hypertension \> 90 mmHg)
* acute severe cardiac insufficiency (New York Heart Association IV)
* known right-left-shunt
* pregnancy and breastfeeding
* Substance dependence
Single-arm Study to Evaluate the Safety and Efficacy of Pazopanib, in Subjects With FGFR2 Amplification, FGFR2 Mutation Refractory Solid Tumors

This is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation Refractory solid tumors.

This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation Pazopanib 800mg will be administered orally once a day 28 days.Study treatment will be continued until objective disease progression.

To investigate the efficacy of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of fully informed consent prior to any study specific procedures.
2. Patients must be ≥20 years of age.
3. FGFR2 amplification or FGFR2 mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
4. ECOG performance status 0-2.
5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
6. Adequate Organ Function Laboratory Values

   * Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
   * bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
   * creatinine ≤1.5 x UNL
7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
8. Adequate heart function.

Exclusion Criteria:

1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
2. Has known active central nervous system (CNS) metastases.
3. Has an active infection requiring systemic therapy.
4. Pregnancy or breast feeding
5. Patients with cardiac problem.
6. Any previous treatment with Pazopanib.
Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes

Pacemaker electrodes are either equipped with tines (passive fixation) or with a screw (active fixation) for initial fixation in the patient´s heart. Both types of electrodes provide similar results in a long-term follow-up and the use of one or the other electrode type in many instances is mainly based on the implanter´s preference. The PACMAN-trial investigates whether the two lead types are associated with different amounts of myocardial micro-damage during implantation.


Eligibility Criteria:
Inclusion Criteria:

* de-novo implantation of a pacemaker system

Exclusion Criteria:

* AAI pacing or cardiac resynchronization therapy
* ICD indication
* temporary pacing
* lead revision
* right ventricular pacing aimed from alternative pacing sites (other than the apex)
* lead revision
* severe tricuspid valve regurgitation
* previous myocardial infarction, coronary intervention, stroke, cardioversion or ablation in the presence of elevated troponin levels
* dialysis
Improving Quality of Care for Elderly Patients in the Educational Setting

This is a multi-center exploratory study (each site got local IRB approval) of the impact of an educational toolkit combined with a practice-performance self-evaluation instrument (ABIM Care of the Vulnerable Elderly Practice Improvement Module) on trainee knowledge, skills, and attitudes about practice-based learning and improvement and systems-based practice in the care of elderly patients.

This is a longitudinal quasi-experimental study. Programs will be randomly assigned to either the comparison or intervention group, stratified based on program size, affiliation, geographic location, and presence of a geriatrics fellowship program.

Faculty will be trained in use of the CoVE PIM and in the development and implementation of a quality improvement plan. Residents in the intervention group will perform the medical record audit portion of the CoVE PIM. Patient surveys will be distributed by the residency clinics. The goal will be to audit the medical records of patients who complete the patient survey. Residents in intervention groups will participate in completing the practice system survey as a group. Finally, the residents in the intervention group will use the data from the medical record audit, patient survey, and practice system survey, working with faculty, to develop a quality improvement project to improve care for their geriatric patients.

Local medical record abstractors will be trained to perform a separate medical record audit of a random sample of the same patients identified by the residents for both the intervention and comparison groups. The abstractors will perform both a baseline and follow-up audit and will target the same patients who are still living from the baseline period. The follow-up audit will occur 12 months after completion of the initial PIM data collection phase, or approximately 18 months after the initiation of the study.

Evaluation of study outcomes will occur on the program, resident, and patient level.

Eligibility Criteria:
Inclusion Criteria:

* All residents at a resident clinic site
* Preceptors that are selected by the Champion for a particular resident clinic site
* Patients age 65 years or older for whom any of the following measures would be appropriate: falls prevention, identifying urinary incontinence, screening for depression and cognitive impairment, and providing other preventive care.
* Patients who have been in the practice for at least one year
* Patients who are ambulatory
* Patients who have been seen at least once by the practice within the past 12 months.

Exclusion Criteria:

* Patients under age 65
* Patients who have a terminal illness
* Patients with a life expectancy of less than one-year
Reusable Duodenoscope Culture Registry

This project is being performed to examine the results of duodenoscope cultures following standard of care cleaning and reprocessing.

This project is being performed to examine the results of duodenoscope cultures following standard of care cleaning and reprocessing. This information will allow us to elucidate the number of endoscopic procedures that can be performed using a single duodenoscope until microorganisms are cultured from duodenoscopes after standard of care cleaning and reprocessing. This will in turn allow us to improve the delivery of healthcare to patients undergoing endoscopic procedures.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater
* Any patient undergoing endoscopic retrograde cholangiopancreatography procedure using a reusable duodenoscope

Exclusion Criteria:

* Less than 18 years of age
Longitudinal Study of Asthma From Birth to Adulthood

To extend follow-up of a birth cohort of asthmatic children through adolescence and on to adulthood. .

BACKGROUND:

The population under study is the cohort from Tucson Children's Respiratory Study (CRS), which began in 1980.

DESIGN NARRATIVE:

The longitudinal study follows a birth cohort of children, initially established in the 1980s. The study period took the children through their 16th birthday, when a comprehensive respiratory and allergy assessment was conducted. This extended follow-up took the cohort from birth to an age at which lung growth is virtually complete for girls and ending its most rapid phase for boys.

The resulting data set was used to test diverse hypotheses concerned with lower respiratory tract illnesses (LRI), asthma, wheezing, allergy, and smoking. There were four broad areas: 1) effects of LRI during the first three years of life and early and late symptoms and allergic sensitization on the picture of asthma; 2) changes during adolescence in symptoms and airways responsiveness; 3) the natural history of allergic sensitization and its relation to asthma and asthma-like symptoms; and 4) the change in longitudinal lung function and factors affecting the change.

A well documented data set was available to test these hypotheses. LRI were documented during the first three years of life, atopy was evaluated, symptom status tracked, and lung function periodically measured. Infant lung function was assessed for a sample of the children and methacholine challenge was performed at age 11. In the evaluation at age 16 years, symptoms, lung function, including methacholine responsiveness, and atopy and lymphocyte phenotype were assessed. Various methods for longitudinal data analysis were used.

The study was renewed in 2001 to follow the birth cohort into early adulthood in order to generate data on the mechanisms and risk factors associated with asthma in early adult life. Specifically the study will: 1) identify factors that alter persistence and remission of asthma symptoms among young adults who developed asthma in childhood; 2) assess the role of persistent eosinophilia during childhood as a mechanism which determines progression and incidence of asthma in early adult life, and prevalence of persistent bronchial hyperresponsiveness (BHR); 3) measure noninvasive markers of airway inflammation in early adult life, and identify correlates of these markers, both with childhood and current asthma symptoms, BHR and immune system indicators of allergy; 4) predict early (by age 20 ) decline in lung function with reference to childhood lower respiratory tract illnesses, asthma-like symptoms, and the initiation of smoking; and 5) investigate the role of gender in incidence of and risk factors for asthma during adolescence and young adult life.

Eligibility Criteria:
No eligibility criteria
Application of MRI Radiomics Features in Neoadjuvant Therapy of Head and Neck Squamous Cell Carcinoma

Head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Neoadjuvant therapy, including neoadjuvant chemotherapy and immunotherapy, is recommended for patients with locally advanced head and neck cancer. The response to neoadjuvant therapy varies among the patients. It is reported that about 37% of the patients achieve pathological complete response after receiving neoadjuvant therapy, who would achieve a better prognosis compared with the patients with non-pathological complete response. It is significant to predict and assess response to neoadjuvant therapy for the patients with head and neck cancer accurately, which could assist in formulating individualized therapeutic regimens. MRI has good soft tissue resolution and is a common preoperative examination method. However, this method lacks the ability to accurately predict the probability of patients achieving pathological remission after neoadjuvant therapy. At present, it is a novel and effective method to construct a model to predict the efficacy of neoadjuvant therapy based on MRI image omics analysis, and certain achievements have been made in breast cancer and rectal cancer. In this study, multi-sequence MRI was combined with clinical risk factors to construct an imaging omics model to predict the probability of pathological complete remission of patients with head and neck squamous cell carcinoma after neoadjuvant therapy, and to accurately identify diagnostic imaging remission, so as to better assist clinical decision-making.


Eligibility Criteria:
Inclusion Criteria:

* (a) patients pathologically diagnosed as head and neck squamous cell carcinoma;
* (b) patients receiving two or three courses of neoadjuvant therapy (traditional chemotherapy plus PD-1 inhibitor);
* (c) MR scan within 30 days before the first course of neoadjuvant therapy;
* (d) patients undergoing radical surgical dissection following neoadjuvant therapy;
* (e) complete clinical data available.

Exclusion Criteria:

* (a) previous head and neck treatment history;
* (b) obvious motion or metal artifacts on the MRI image;
* (c) distant metastasis;
* (d) concurrent malignancies.
Musculoskeletal Disorders of Workers in a Production and Distribution Company in Argentina

Describe musculoskeletal disorders of workers in a company in Argentina regarding working areas and demographic carachteristics of the workers.

We are analyzing the first consultation registration of every worker that had been attended by the physiotherapist in a clinic that is located inside the company. These records consist on demographic data and also injury related information.

Eligibility Criteria:
Inclusion Criteria:

* workers in a production and distribution company in Argentina that walks into the clinic inside the company

Exclusion Criteria:

* lack of registered information
Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares

Determine the effect of ARS-1 on a patient reported pruritus/hive score


Eligibility Criteria:
Inclusion Criteria:

* 1. Male or female subject between the ages of 18 and 65 years.
* 2. Clinically diagnosed urticaria with acute symptom flares at least two (2) times a week while on a chronic treatment.
* 3. Body weight more than 30 kg and body mass index between 18 and 34 kg/m².
* 4. Has no medical history of hypertension and cardiovascular disease in the last 10 years.
* 5. At screening, has stable vital signs.
* 6. If female, is not pregnant or breastfeeding.
* 7. If male (with or without vasectomy), agree to the use of highly effective contraceptive methods at screening until 7 days after the last day of study drug.

  8. Is able to communicate clearly with the Investigator and staff. 9. Provide written informed consent prior to participating in the study.

Exclusion Criteria:

* 1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease.
* 2. Patients receiving beta blocker due to potential interaction with the study drug.
* 3. Prior nasal fractures, severe nasal injuries or history of nasal disorders.
* 4. Clinically significant medical condition or physical exam finding.
* 5. Abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal ECG.
* 6. Mucosal inflammatory disorders.
* 7. Significant traumatic injury or major surgery within 30 days prior to study screening.
* 8. Has donated blood or had an acute loss of blood (\>50 mL) during the 30 days before study drug administration.
* 9. Known hypersensitivity to any compound in the test product.
* 10. Participated in a clinical trial within 30 days prior to the first dose of study drug.
Benefit of Allogeneic Haematopoietic Stem Cells in Cutaneous T-cell Lymphomas Epidermotropic With Advanced Stage and Poor Prognosis

Epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant, Sézary syndrome, are the most frequent subtypes of cutaneous T-cell lymphomas. MF typically runs an indolent course in its early stages. By contrast, advanced-stage ETCLs share a very bad prognosis: Patients usually show early relapses after chemotherapy, prolonged complete remissions exceptionally occur and quality of life is severely affected. Several publications have reported durable responses following allogeneic hematopoietic stem cell transplantation (HSCT) in advanced-stage ETCLs. This study aims to investigate the role of allogeneic HSCT in treating advanced-stage ETCLs. An observational, prospective, multicenter, controlled study will compare the outcomes of patients who receive reduced-intensity conditioned allogeneic HSCT from a sibling or 10/10 HLA-matched unrelated donor to those of patients who receive standard of care in patients with advanced-stage ETCL with poor prognostic features, will be performed. Patients are included at the time of donor search irrespective of the results, and compared on a donor versus no donor basis. It is an observational study since no intervention is made except the comparison of outcomes of groups that receive usual care (HSCT if donor available, or not).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 65 years
* Histopathologically confirmed diagnosis of International Society for Cutaneous Lymphomas (ISCL) / European Organisation for Research and Treatment of Cancer (EORTC) stage IIB, III, IVA or IVB ETCL
* Complete or partial response of the lymphoma (as defined by the international ISCL-EORTC criteria at the time of inclusion
* Written informed consent given by the patient
* Contraception in women of childbearing age
* Hematopoietic stem cell donor search underway

And at least one of the three following criteria:

* Refractoriness or early relapse (i.e. within one year) after at least one line of systemic chemotherapy (not including skin-directed therapies, methotrexate, interferon-alpha, and oral retinoids)
* Early histological large-cell transformation, i.e. within two years following ETCL diagnosis
* Histologically proven nodal (ISCL / EORTC N3) or extra-cutaneous visceral involvement by the lymphoma

Exclusion Criteria:

* Prior allogeneic HSCT
* Other progressive neoplastic disease
* Progressive psychotic disease
* Left ventricular ejection fraction \< 50% (as determined by trans-thoracic echocardiography)
* Pulmonary disease with FEV1, FVC or DLCO \<30% of expected corrected for hemoglobin.
* Creatinine clearance \<50 ml/min or requiring dialysis
* Transaminases or bilirubin \>two-fold the normal value in the absence of liver involvement by the lymphoma
* Pregnant or breastfeeding woman
* Patient with no health coverage
* Patient under guardianship or curatorship
* HTLV-1 lymphoma
A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis

This Phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized withdrawal period followed by an open label long term safety extension will evaluate the safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD) on hemodialysis and peritoneal dialysis.

The study consists of a screening visit, a phosphate binder-free washout period of up to 4 weeks, a 26-week treatment period, an up to 12-week placebo-controlled, randomized withdrawal period, during which patients are randomized 1:1 to either remain on their tenapanor treatment or placebo, followed by an open label safety extension period for a total treatment period of up to 52 weeks. An active control group, for safety analysis only, will receive sevelamer carbonate, open label, for the entire 52-week study period

Depending on increase in serum phosphate (s-P) levels, subjects can be randomized 2 or 3 weeks after being taken off their phosphate lowering medication.

Subjects who qualify to enroll in the study will be randomized 3:1 to either receive tenapanor at a dose of 30 mg bid or sevelamer carbonate.

Eligibility Criteria:
Inclusion Criteria:

* Females must be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods
* Males must agree to avoid fathering a child and agree to use an appropriate method of contraception
* Chronic maintenance hemodialysis 3x a week for at least 3 months
* Chronic maintenance peritoneal dialysis for a minimum of 6 months
* Kt/V ≥ 1.2 at most recent measurement prior to screening
* Prescribed and taking at least 3 doses of phosphate binder per day
* Serum phosphorus levels should be between 4.0 and 8.0 mg/dL at screening
* Unchanged dose of vitamin D or calcimimetics for the last 4 weeks prior to screening
* For enrollment in the study after at least 2 weeks of wash-out, subjects must have serum phosphorus levels of at least 6.0 mg/dL but not more than 10.0 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value after 2 or 3 weeks wash-out of phosphate binders

Exclusion Criteria:

* Severe hyperphosphatemia defined as serum phosphorus greater than 10.0 mg/dL on phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening visit
* Serum/plasma parathyroid hormone \>1200 pg/mL
* Clinical signs of hypovolemia at enrollment
* History of IBD or IBS-D
* Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period
* Positive serology with evidence of significant hepatic impairment or WBC elevation according to the Investigator
* Life expectancy \<6 months
* Previous exposure to tenapanor
Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion

To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea


Eligibility Criteria:
Inclusion Criteria:

* Women with secondary amenorrhea
* Normal serum Dehydroepiandrosterone (DHEA), prolactin, testosterone, Thyroid Stimulating Hormone (TSH) and thyroxine

Exclusion Criteria:

* Primary amenorrhea
* Other medical conditions resulting in amenorrhea (e.g. Asherman's syndrome)
* Peanut allergy
* Allergy to progestational steroids