cyrilzakka/clinical-trials huggingface dataset:
Health Literacy, Physical and Cognitive Function, Health-related Behaviors, and Quality of Life in COPD

Health literacy is important for controlling disease progression and living a healthy life with illness. High health literacy is associated with higher cognitive performance and lower health-related quality of life. Physical, psychological, and social impairments are seen in chronic obstructive pulmonary disease (COPD). Studies investigating the relationship between health literacy and functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living in individuals with COPD are limited. Therefore, the aim of this study was to compare individuals with COPD with healthy individuals in terms of health literacy, functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living and to investigate the relationship between health literacy and functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living in individuals with COPD.


Eligibility Criteria:
Inclusion criteria for the COPD group:

* Being over 40 years old,
* Diagnosed with COPD and being clinically stable,
* Being able to cooperate with the tests to be performed,
* Not having any cardiovascular disease, orthopedic or neurological problems that may affect the tests,
* Being willing to participate in the study.

Exclusion criteria for the COPD group:

* Being in an acute exacerbation period,
* Having any cardiovascular disease, orthopedic or neurological problems that may affect the tests,
* Not being willing to participate in the study.

Inclusion criteria for the control group:

* Being willing to participate in the study and being over 40 years old
* Not having any known disease

Exclusion criteria for the control group:

* Not being able to cooperate with the tests to be performed
* Not being willing to participate in the study
Akershus Early Mobilisation in Stroke Study

Treatment in stroke units compared with treatment in general medical wards reduces the odds of being dead or disabled. Little is known about which components of acute stroke care that is responsible for this benefit.

Early mobilisation is one of the features of stroke unit care. In Scandinavia, any intervention aimed to reduce the time to the first out of bed episode has been focused in order to prevent complications.

However, therapeutic interventions for cerebral revascularisation and a more intensive unit approach for observation may postpone mobilisation. The aim of the present study is to identify whether early mobilisation (\< 24 hours after admittance to hospital)reduce disability and mortality compared with mobilisation after 24 hours.

The study is a prospective, randomised controlled study with blinded assessment at the end of follow up. Patients admitted to the Stroke Unit, Akershus University Hospital less than 24 hours after stroke during 2009 - 2011 are screened for recruitment. Patients are randomly assigned to either mobilisation out of bed within 24 hours from admittance to hospital or mobilisation after 24 hours. Except early contra late mobilisation all patients receive standard stroke unit care.

Patients with modified Rankin Scale 0 and 1, patients with a secondary intracerebral hemorrhage, patients receiving thrombolysis or patients requiring palliative care are excluded.

All patients are assessed at admittance, discharge and 3 months poststroke. Investigations at admittance include standard blood sample, CT/MRI scan, EKG and ultrasound of carotid arteries.

Main outcome is mortality and disability 3 months poststroke. Secondary outcome measures are neurological deficits (NIH), morbidity, complications, cognitive function reflected by Mini Mental State Examination and emotional function (Hospital Anxiety and Depression scale) .

Results from this study may add important knowledge about how and when to start mobilisation of patients with acute stroke.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the Department of Neurology, Akershus University Hospital, with acute stroke (ischemic or hemorrhagic)

Exclusion Criteria:

* admitted to hospital more than 24 hours after stroke onset
* mRS 0 and 1
* mRS 5
* patients requiring palliative care
* secondary/traumatic intracerebral hemorrhage
* pregnancy
* i.v./i.a. thrombolysis
Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.


Eligibility Criteria:
Key Inclusion criteria:

• Osteoarthritis of the hand

Key Exclusion Criteria:

* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs
Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus

The overall aim of this feasibility study is to develop new technologies for improved detection of Barrett's neoplasia using the scanning fiber endoscope(SFE) multiplexed imaging system. This study will combine the use of fluorescent-labeled peptides that bind specifically to pre-cancerous mucosa in the esophagus for use as novel imaging agents to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1 study will be used to provide early evidence of efficacy for the topical application of a panel of two peptides that bind to molecular targets that are specific for esophageal dysplasia. A panel is needed because cancer in the esophagus is genetically heterogeneous. The study will look at peptide binding in subjects with known or suspected Barrett's esophagus.


Eligibility Criteria:
Inclusion Criteria:

* Known or suspected Barrett's esophagus
* Scheduled for a clinically-indicated upper endoscopy
* Medically cleared for the procedure
* Willing and able to sign informed consent

Exclusion Criteria:

* Known allergy or negative reaction to the near infrared fluorophores Cy5, li-cor IRDye800CW, or derivatives
* One active chemotherapy or radiation treatment
* Pregnant or trying to conceive
A Prospective, Observational Study of COPD Patients in U.S. Hospitals

This is an observational study to evaluate the relationship between pulmonary function and the patient reported health-related quality of life (HRQoL) and chronic obstructive pulmonary disease (COPD) related admissions. Patients with COPD will be approached to participate in the study. Pulmonary function will be measured on consented, eligible patients. The pulmonary function measurement collected will be used for cohort assignment. The prospective follow up period will monitor the cohorts for evidence of readmission and to assess HRQoL.


Eligibility Criteria:
Inclusion Criteria:

≥ 18 years of age Fluent in English Current hospital admission is for COPD Diagnosis of COPD for at least 1 year prior to enrollment

Exclusion Criteria:

Unwilling or unable to provide informed consent
A Study to Assess the Safety and Efficacy Of Tafamidis In Chinese Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

This is a national, multi-center, single-arm study, open-label to patients with symptomatic Transthyretin amyloid cardiomyopathy (ATTR-CM) who are tafamidis naïve. This study is to obtain safety, descriptive efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) data for tafamidis orally once daily.

Subject eligibility for participation in the study will receive tafamidis once daily or 12 months following the assessment as the screening and baseline, month 1, 3, 6, 9 and 12 visits (or Early Study Discontinuation).


Eligibility Criteria:
Inclusion Criteria:

1. Subject has documented ATTR-CM.
2. For the reproductive criteria for male and female participants, please refer to relevant protocol sections.

Exclusion Criteria:

1. Other acute or chronic medical or psychiatric condition including recent or active suicidal ideation or behavior or laboratory abnormality, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
2. Participants who have prior liver and/or heart transplant.
3. Participants with primary (light chain) or secondary amyloidosis.
4. Previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial

Surgeons commonly prescribe post operative prophylactic antibiotics after sinus surgery. There is minimal data to support this. The investigators' study will aim to demonstrate that patients' quality of life and rate of post operative infection is the same whether they receive or do not receive antibiotics post operatively. The investigators hypothesis is that the disease specific quality of life of patients taking post-operative antibiotics is not inferior to the quality of life of patients who do not take post-operative antibiotics, and the rate of post-operative infections are the same. The investigators' specific aim is to compare validated symptom scores between post-operative populations who are given or are not given antibiotics. Rates of infections in the first 10 days after surgery will be recorded. The investigators will also compare endoscopic grades of sinus cavities during the post-operative follow up exams as an additional outcome measure.

Functional endoscopic sinus surgery (FESS) is a commonly performed procedure in the United States to treat chronic rhinosinusitis. Common practice is to prescribe prophylactic antibiotics postoperatively. This is similar to the long tradition of prophylactic antibiotics after tonsillectomy. The American Academy of Otolaryngology - Head and Neck Surgery recently strongly recommended against prophylactic antibiotics after tonsillectomy. In this light, this study would demonstrate the lack of need for antibiotics after FESS. Currently one surgeon does not prescribe antibiotics except when evidence of active infection was found during surgery. The other surgeon in the study currently prescribes antibiotics. This study would prospectively compare the two groups in a randomized fashion. The investigators' plan to use the Sinonasal outcomes test - 22 (SNOT-22) as the investigators' primary outcomes measure, which is a validated quality of life instrument in sinusitis.

Eligibility Criteria:
Inclusion Criteria:

- Patients eligible for surgery would be patients with chronic rhinosinusitis (defined by the AAOHNS 2007 consensus statement by Rosenfeld et al) and have been determined by their surgeons to have persistent symptoms after maximal medical therapy. Maximal medical therapy is defined as a course of broad spectrum or culture-directed antibiotics used in conjunction with a nasal steroid.

Exclusion Criteria:

1. Penicillin, cephalosporin, amoxicillin/clavulanate allergy
2. Cystic Fibrosis
3. Immunodeficiency
4. Presence of any foreign body (ie.absorbable and non-absorbable packing) after surgery
5. Odontogenic causes of sinusitis
6. Fungal ball
7. Infected mucocele
8. Complication of sinusitis (meningitis, orbital complication, cellulitis, brain abscess)
9. Non endoscopic sinus surgery (Caldwell luc, external approaches, etc)
10. Age \<18
11. Pregnant women
Mifepristone (RU-486) in Androgen Independent Prostate Cancer

The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.

Patients will receive mifepristone, 200mg orally once a day. One treatment cycle is 28 days long. Patients will remain on treatment unless their cancer gets worse or they develop intolerable side effects.

At the end of each cycle a physical examination, routine blood tests, and hormone levels will be performed.

After every 3 cycles, one or more of the following will be performed: bone scan, chest x-ray, CT scan or MRI.

Eligibility Criteria:
Inclusion Criteria:

* Histologic documentation of adenocarcinoma of the prostate
* Bone metastasis(es) by bone scan or cat scan
* Clinical, biochemical, or radiographic progression after primary androgen ablation with either orchiectomy or gonadotropin releasing hormone analog therapy.
* One prior chemotherapy treatment is allowed.
* \> 3 weeks since major surgery
* \> 4 weeks since radiotherapy
* \> 8 weeks since prior strontium-89 or samarium 153
* ECOG performance status 0 or 1
* Absolute neutrophil count (ANC) \> 1,500/ul
* Platelets \> 100,000/ul
* Bilirubin \< 1.5 x upper limit of normal (ULN)
* AST or ALT \< 3 x ULN
* Creatinine \< 1.5 x ULN
* Electrolytes within 10% of normal range
* Serum testosterone \< 50ng/dL
* Prostate-specific antigen (PSA) \> 5.0ng/ml

Exclusion Criteria:

* Concomitant therapy with corticosteroids
* Chemotherapy within 28 days
* Currently active second malignancy other than non-melanoma skin cancer
* Baseline adrenal insufficiency requiring long-term steroids
Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer

RATIONALE: Vaccines may make the body build an immune response to tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have stage III or stage IV cancer.

OBJECTIVES: I. Determine the safety of serial intradermal or subcutaneous vaccinations of HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide (PLG) microspheres with adjuvant sargramostim (GM-CSF) in patients with stage III or IV HER-2 expressing cancers. II. Determine whether cytotoxic T lymphocytes (CTL) specific for the HER-2 protein can be elicited in patients with HLA-A2 by immunization with this regimen. III. Determine which route of immunization, intradermal or subcutaneous, is more effective in generating HER-2 specific CTL in these patients on this regimen. IV. Determine the extent to which escalated dose of PLG peptide affects the immune response in these patients on this regimen.

OUTLINE: Patients undergo leukapheresis prior to study and after final vaccination. Patients are sequentially entered into one of three treatment arms: Arm I: Patients receive an intradermal vaccination of HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide (PLG) microspheres with adjuvant sargramostim (GM-CSF). Arm II: Patients receive a subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG microspheres with adjuvant GM-CSF. Arm III: Patients receive a higher dose of subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG microspheres with adjuvant GM-CSF. Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: A total of 15 patients (5 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Stage III adenocarcinoma that overexpresses HER-2 and previously treated by surgical resection, conventional chemotherapy, or radiotherapy OR Stage IV adenocarcinoma that overexpresses HER-2 and in stable or complete remission with no other concurrent chemotherapy Must have documented HER-2 protein overexpression in the primary or metastatic tumor HLA-A2 positive

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 90-100% Life expectancy: At least 12 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: Female patients must have completed childbearing Fertile male patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since prior corticosteroids Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No other concurrent investigational phase I studies
Reference Interval for SPO2 in Neonates at High Altitudes During First 2 Hours and Umbilical Artery Blood Gas

Pulse oximetry offers real time and non-invasive estimation of arterial oxygen saturation in a cost-effective way, and has become a critical tool in guiding the usage of supplemental oxygen in sick newborns. During postnatal transition, pulmonary pressure decreases upon the activation of the lungs, and the ductus arteriosus constricts and closes upon the increase of partial oxygen pressure, which is negatively correlated with altitude. As a result, postnatal transition may be different at high altitudes. Umbilical cord blood gas analysis is now recommended in all high-risk deliveries because of its' value in providing information about preceding fetal hypoxic stress. But there are only limited studies about the SpO2 measurements during the first few hours after birth and umbilical blood gas analysis at high altitudes, especially at altitudes above 2500m. The primary outcome of the study is to determine the reference intervals for preductal oxygen saturation during first 2 hours of life stratified by different gestational age. The secondary outcomes is to establish the pH and lactate cutoff value of umbilical arterial blood gas at different altitude level.


Eligibility Criteria:
Inclusion Criteria:

* Infants with a gestational age between 35 to 42 weeks who were born alive and appearing well as defined by:

  1. normal vital signs (heart rate ranging from 110 to 180 beats/minute, respiratory rate ranging from 30 to 60 breaths/minute, temperature ranging from 36.5°C to 37.5°C),
  2. absence of signs of illness such as respiratory distress.
  3. the mothers resided in the study area.

Exclusion Criteria:

* outborn, require resuscitative interventions at birth beyond blow-by oxygen,
* require admission for any reason other than observation or had a major congenital anomaly.
A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery

The purpose of this study is to develop an all-encompassing frailty model using laboratory and functional studies. A frailty model will help us determine prior to surgery who will require rehabilitation and skilled nursing needs beyond discharge. This model will also help us determine who will likely be readmitted and why they will be readmitted. Understanding these things can help us prevent some of them from occurring in the future.

Frailty is a widely accepted but poorly defined physical condition that has been shown to be an independent predictor of surgical morbidity and direct discharge to skilled nursing facility (SNF). Attempts have been made to study frailty in surgical patients by employing models designed for the general population. Despite the attempts of studying frailty in general surgery patients, no study has designed a model comprised of objective metrics for general thoracic surgery patients.

The purpose of this study is to better understand frailty in the context of thoracic surgery patients and to develop an objective model of this nebulous variable. It is hoped that standard, simple, functional and laboratory data can be used to construct the model with the goal being to determine the impact of frailty on outcome for patients undergoing esophagectomy, lobectomy, or pneumonectomy. If a preoperative frailty index can be developed and demonstrated to predict outcome, this scoring system may allow care teams to predict post-operative complications, ICU and hospital recidivism, and early mortality, and possibly allow for much earlier preparation for unfavorable outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All patients \>18 years old who are undergoing pneumonectomy, lobectomy or esophagectomy with a cancer diagnosis over a 1-year enrollment.

Exclusion Criteria:

* Patients who are unable to sign a consent.
Alternatives to Hand Therapy for Hand Surgery Patients

Patients will be asked to use a mobile phone app to conduct their hand therapy after having hand surgery.

Patients who are undergoing the included procedures will be informed of the study \& consented. They will be given information on how to download the app \& input their surgery date. The app will guide the patient through various hand therapy exercises and ask them to record their QuickDASH, PSFS and VAS Pain weekly.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing the following procedures: carpal tunnel release, trigger finger release, distal radius fracture fixation, de quervains release, cyst excision, finger fracture fixation
* smart phone that is compatible with the app

Exclusion Criteria:

-
Participation to Colorectal Cancer Screening With Fecal Occult Blood Test and Colonoscopy

Adherence rate to screening colonoscopy (TC) in the average-risk general population is still unclear. Aim of this study was to compare the uptake of TC screening with that of fecal occult blood (FOBT) in the general population of different Italian areas.

A nationwide, population-based, multicenter, randomized trial comparing attendance to TC with that to FOBT was performed. Sixty-four general practitioners (GPs), overall including in their lists 9,889 average-risk subjects aged 55-64 years, were randomized between TC and FOBT screening programs. Eligible subjects were mailed a personal invitation letter co-signed by their GP and the coordinator of the area-reference GI centre. Attendance rate and detection rate for advanced neoplasia (colorectal cancer, adenoma \>10 mm or with villous histology or high-grade dysplasia) for each arm of the study were assessed.

Eligibility Criteria:
Inclusion Criteria:

* asymptomatic 55-64 years subjects

Exclusion Criteria:

* already studied for colorectal cancer, severe comorbidities