cyrilzakka/clinical-trials huggingface dataset:
Quality of Life and Target Achievement After Treatment of Patients With Stable Angina Pectoris

The purpose of this study is to, in patients with stable angina pectoris, assess the additional benefit of PCI on top of optimized medical treatment, physical training and smoking cessation with regard to quality of life, achievement of target of treatment and clinical events such as death, acute myocardial infarction, stroke and revascularization.

Patients with stable angina pectoris with a significant coronary stenosis will be randomized to optimized medical treatment, physical training and smoking cessation or to optimized medical treatment, physical training, smoking cessation and complimentary treatment with PCI. All patients will be followed up at six months and at one and five years regarding symptoms, blood lipids, systemic blood pressure, physical training status, smoking habits, and maximal exercise ECG.

Achievement of target of treatment will be measured by questions regarding the patients' expectation of the treatment at baseline and at a 6 month follow-up. The questions at 6 months will be based on the interviews at inclusion. Furthermore quality of life will be measured with three different measuring instrument; SF-36 short form, Seattle Angina Questionnaire (SAQ), and EQ-5D. These instruments will be given to the patients at baseline, at six months and at the five year follow up.

Eligibility Criteria:
Inclusion Criteria:

* Stable coronary artery disease
* Angina pectoris with at least angina class 2 according to Canadian Cardiovascular Society (CCS)
* Angiographic verified stenos in a native vessel
* Accepted for PCI

Exclusion Criteria:

* Instable coronary artery disease or AMI withín two months
* CCS class IV
* Stenosis in Left main and/or proximal LAD
* NYHA- III-IV
* Fall in blood pressure during exercise test \> 10mm Hg, measured two times
* Contraindication or allergy against clopidogrel or ASA
* Unable to communicate verbal or i writing
* Unwillingness to participate in the study
* Participating in an other study
Nutrition and Physical Exercise Study

The purpose of this study is to investigate the effect of a combined treatment of nutritional therapy and physical exercise in palliative cancer out-patients. The investigators hypothesize that this combined intervention consisting of an increased energy- and protein intake and physical exercise level improves quality of life (QoL), functional and clinical status.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic lung cancer or gastrointestinal cancer
* WHO performance status 0, 1 or 2
* Able to walk at least 100 meters independently without crutches or walking frame assessed by the treating physician on the basis of the patient's history and physical condition
* Receiving palliative treatment

Exclusion Criteria:

* Enteral and/or parenteral nutrition within 1 month previous to study participation
* History of ileus within one month
* Known brain metastases or symptomatic bone metastases
* Psychiatric disorder precluding understanding of information on trial related topics and giving informed consent.
* Any serious underlying medical condition which could impair the ability of the patient to participate in the trial
TTS Esophageal HILZO Stent: A Safety and Feasibility Study

A multicenter non-randomized prospective clinical study assessing the safety and feasibility of the esophageal through-the-scope HILZO Covered self-expandable metal stent placement for palliation of malignant dysphagia

The main objective of this study is to evaluate the safety and efficacy of placement of the esophageal HILZO Covered stent with the TTS method in patients with non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy.

Other (secondary) objects are to assess the effect of the stent on the presence of hyperplastic reaction after implantation, the functional complications and survival.

Eligibility Criteria:
Inclusion Criteria:

* Non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy. A tumor is considered inoperable if the patient has local tumor infiltration in the surrounding organs, distant metastases or a poor general health due to serious concomitant disease. OR
* Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal or gastric cardia cancer.
* Requiring treatment for dysphagia (dysphagia score of ≥ 2, according to Ogilvie2)
* Written informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Inappropriate cultural level and understanding of the study.
* Simultaneous participation in another clinical study
* Life expectancy of less than 12 months
* Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
* Tumor length of more than 12cm
* Previous stent placement for the same condition
Digital Health Intervention to Promote Quality of Life in Adults With Chronic Graft Versus Host Disease

The goal of this interventional study is to learn if the Horizons mobile application is feasible for survivors of allogeneic hematopoietic stem cell transplant who have chronic graft-versus-host disease. Participants will be asked to complete surveys and use the Horizons mobile application.


Eligibility Criteria:
Inclusion Criteria:

* Underwent allogeneic hematopoietic stem cell transplant
* Have moderate to severe chronic graft-versus-host disease
* Currently receiving care at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program
* Able to use an Ipad to participate in the Horizons app intervention
* Able to participate in study procedures in English

Exclusion Criteria:

* comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention
* Vulnerable patients, defined here as prisoners and pregnant women
The Role of Radial Peripapillary Vessel Density in Irvine-gass Syndrome

Pseudophakic cystoid macular edema (PCME), also known as Irvine-Gass syndrome (IGS), is an accumulation of fluid in the macula that occurs after cataract surgery, with an early or late presentation (cut-off 3 months) . It is the most common cause of decreased vision after uneventful phacoemulsification, with a rare incidence of 0.1-2.35% for clinically significant PCME .

Macular edema in IGS can be diagnosed and classified by optical coherence tomography (OCT), which enables its morphologic assessment. Fluorescein angiography (FA) is the gold standard to perform differential diagnosis for macular edema.

To date, OCT angiography (OCTA) has been proposed to study various retinal vascular diseases. In contrast to FA, OCTA is able to visualize Radial peripapillary vessel density (RCP).

The aim of this study was to investigate abnormalities in the vascular network of the optic nerve head in patients with IGS compared to healthy eyes, using OCT-A


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of PCME Cataract surgery

Exclusion Criteria:

diabetes vein occlusion uveitis vasculitis age-related macular degeneration hereditary macular dystrophy

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Mozzarella Cheese Vitamin D and Bioavailability

The purpose of this study is to evaluate the effect of heat on the bioavailability of vitamin D in industrially fortified mozzarella cheese baked with pizza.

With a growing body of evidence, the Institute of Medicine (IOM) conducted a thorough review of all available evidence to publish a report on Dietary Reference Intakes (DRIs) for calcium and vitamin D. In the absence of adequate sun exposure, acquiring the new RDA of 600-800 IU/d for vitamin D through diet alone is difficult. There is a need to increase dietary sources of vitamin D for Canadians.

In a double blind, randomized trial, our objective was to assess the effect of high temperature pizza baking on the bioavailability of vitamin D3 fortified Mozzarella cheese. We tested the following hypotheses, set a priori: 1) vitamin D3 is bioavailable from pizza baked with fortified Mozzarella cheese and heat does not significantly break down vitamin D3; and 2) the change in serum 25(OH)D (from baseline to 10 wk) will be significantly greater in the high-dose vitamin D treated group (28000 IU/wk) compared to the low dose vitamin D-treated group (200 IU/wk).

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females between ages 18-70 years

Exclusion Criteria:

* Use of vitamin D supplements in excess of 1000 IU/day
* A history of any medical disorder that might effect vitamin D or mineral metabolism
* Use of medications that could interfere with vitamin D metabolism
* Potential for sun exposure ( i.e travel to a sunny destination of use of tanning beds) within the month prior to or during the study
* History of hypercalcemia
* Unwillingness to return for follow up
Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study)

5 year, open-label study to evaluate safety of SCULPTRA on the signs of lipoatrophy of the face in at least 100 evaluable subjects with human immunodeficiency virus.


Eligibility Criteria:
INCLUSION CRITERIA:

* Subjects seropositive for human immunodeficiency virus;
* In the investigator's judgment, a high probability of 5 year survival and compliance with the study visit schedule;
* Initiating SCULPTRA treatments;
* Ability to comprehend and sign an informed consent document prior to study enrollment.
* No waiver, prospective or retrospective, to deviate in any way from the inclusion/exclusion criteria for clinical study subjects, defined in the study protocol, can be granted to clinical investigators.

EXCLUSION CRITERIA

* Any active skin inflammation or infection in or near the treatment area;
* Any hypersensitivity to the components of SCULPTRA
* Previous treatment with SCULPTRA or any other product for facial lipoatrophy;
* Pregnancy or breastfeeding or anticipating becoming pregnant during the study period; and
* Any other excluding factors that, according to the investigator's judgment, would preclude enrollment in the study.
* No waiver, prospective or retrospective, to deviate in any way from the inclusion/exclusion criteria for clinical study subjects, defined in the study protocol, can be granted to clinical investigators.
Dietary Fatty Acids, PPAR Activated Genes, and CHD

To examine the relationship between genetic and dietary factors that modify the risk of coronary heart disease (CHD).

BACKGROUND:

Coronary heart disease (CHD) is the major cause of death in most industrialized and developing countries. Links between genetic and dietary factors that modify the risk of CHD should give fundamental insight into its causes and improve population-based CHD prevention strategies.

DESIGN NARRATIVE:

The study will identify genes that modulate the association between dietary fatty acids (FAs) and myocardial infarction (MI). The study uses DNA samples obtained during a population-based, case-control study in Costa Rica of 2,150 subjects who experienced myocardial infarctions and 2,150 matched controls. Biochemical measurements, dietary data, and general information are available for this population. One unique aspect of the study is that adipose tissue biomarkers of polyunsaturated FAs will be used to evaluate dietary exposure variables. Adipose tissue biomarkers (i.e., alpha-linolenic and linoleic acid) are very good indicators of intake in this population. Furthermore, this study showed that increased levels of these biomarkers in adipose tissue are strongly associated with decreased risk of MI, whereas an increase in 18:2 trans FAs increase the risk of MI. Gene-diet association studies and a "candidate pathway" approach will be used to elucidate genetic mechanisms that link risk of MI with exposure to polyunsaturated FAs \[including cis and trans isomers of linoleic acid (n-6), and alpha-linolenic acid (n-3)\]. The focus will be on peroxisome proliferator-activated receptor (PPAR) genes, and PPAR-regulated genes, that are involved in vascular inflammation. Among controls, the investigators will examine whether genetic and dietary factors independently affect biochemical markers (phenotypes) of the proposed genes. They will also test whether these phenotypes are more clearly identified when genetic and dietary factors are examined together. Because polyunsaturated FAs are important as activators of PPARs and their capacity to regulate gene expression at the level of transcription, this metabolic system is a suitable candidate for the study.

Eligibility Criteria:
First acute MI Living in catchment area Randomly selected controls Matched for age sex and area of residence
Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery

The purpose of this study is to evaluate the effects of a structured exercise program on musculoskeletal pain of patients in face-down posture after retinal surgery.

After being informed about the study, patients who are planning to get vitrectomy for macular hole or retinal detachment are going to be randomly assigned into two groups; exercise group and control group. All patients are going be admitted to the hospital prior to the surgery. After the surgery is done, the patients are going to maintain a face-down position in the ward until postoperative day 3. After returning to the ward after surgery and completed the pain scoring forms, exercise training is going to be conducted for patients assigned to the exercise group by a physical therapist. Three times of daily self-exercise sessions are going to be performed according to the training provided to the patients. Pain score will be measured on the first, second and the third postoperative days. Patients will be discharged on the third postoperative days.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are getting vitrectomy for macular hole or retinal detachment and planning to maintain face-down posture.

Exclusion Criteria:

* Pre-existing musculoskeletal disorder.
* low visiual acuity in the opposite eye (best-corrected visual acuity less than 20/200 by snellen chart) making patients hard to get the exercise training.
* Patients with posture prescriptions other than the prone position
Vitamin K and Bone Turnover in Postmenopausal Women

This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study supplementation effects on bone turnover and bone density. Women at least 5 years postmenopause with normal bone density who do not use estrogen therapy or the following medications may be eligible:

alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel), zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will take calcium and vitamin D (Citracal) twice a day for the first two months and through-out the study. After the first two months, subjects are randomized to the K1, MK4 or placebo groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at each visit and bone density is performed at 3 study visits.


Eligibility Criteria:
* Female, 5 years postmenopause.
* Ambulatory.
* Community dwelling.
* Able to ingest calcium and vitamin D supplements.
* Willing to restrict vitamin K intake.
* Stable thyroid dose if appropriate.
* No history of hyperthyroidism, hyperparathyroidism or other metabolic bone diseases.
* Absence of hardware in hip and spine.
* History of malignancy within the last five years.
* Not currently using coumadin or warfarin.
* Vitamin D supplements must be less than 800 IU daily.
* Have not used estrogen or other bone-altering medications (see list in study description) within the last year.
* No history of liver disease or malabsorption.
* No known allergy to vitamin K.
* Have not participated in an investigational drug trial within the last month.
Belimumab for Treatment of cGVHD Following Allo-HCT

Given the role of B cells in the pathophysiology of chronic graft versus host disease (GvHD), the association between elevated BAFF levels post-transplant in abnormal B-cell homeostasis and chronic GvHD, and the efficacy of belimumab in the inhibition of soluble human B lymphocyte stimulator protein (BAFF) signaling, these proof-of-principle findings support the rational for use of belimumab as treatment of chronic GvHD.The investigators propose a pilot and feasibility study to assess the safety and tolerability, as well as preliminary efficacy, of belimumab a treatment of cGvHD following allogeneic hematopoietic cell transplantation (alloHCT). The investigators' central hypothesis is that belimumab will be well tolerated and have a favorable effect on chronic GvHD,and we explored therapeutic dosage of belimumab.


Eligibility Criteria:
Inclusion Criteria:

1.18 to 65years old 2.Newly diagnosed, moderate or severe chronic GvHD according to the 2014 NIH Consensus Criteria, requiring systemic immunosuppression 3.Karnofsky performance status greater than or equal to 60% 4.History of prior alloHSCT; any donors, conditioning regimens and graft sources are allowed 5.Newly diagnosed moderate or severe chronic Graft versus Host Disease (GvHD) (according to the 2014 NIH Consensus Criteria, requiring systemic immunosuppression 6.History of prior allogeneic Hematopoietic Stem Cell Transplant (HSCT) (any donors, conditioning regimens and graft sources are allowed).

7.Stable doses of other immunosuppressive medications (e.g., calcineurin inhibitors, mycophenolate mofetil, rapamune, etc.) with no dose increase in the 2 weeks prior to study treatment initiation. Doses may be adjusted for trough levels.

8.Patients tested positive for autoantibodies (ANA titer ≥1:80) and high BAFF levels (plasma concentration ≥15ng/ml).

9.Laboratory parameters as defined below: Serum creatinine less than or equal to 2.0 x ULN AST and ALT less than or equal to 3 x ULN (less than or equal to 5 x ULN if unequivocal liver GvHD) Total bilirubin less than or equal to 3 x ULN 10.Ability to understand and willingness to sign a written informed consent fo

Exclusion Criteria:

1. Relapsed or progressive malignant disease (other than minimal residual disease)
2. History of other malignant diseases, including post-transplant lymphoproliferative disease
3. Rituximab or other anti-B cell-specific antibodies were used in the past 3 months.
4. Uncontrolled infections (including prior aspergillosis) not responsive to antibiotics, antiviral medicines, or antifungal medicines
5. Donor lymphocyte transfusion for donor chimeric relapse or loss.
6. Any other reason at the discretion of the investigators and documented in the medical record that may raise concerns about the subject safety or ability to participate on this study -
Mexican Initiative of Patients With Osteoarthritis and Rheumatoid Arthritis (IMPACTAR)

The purpose of this study is to evaluate quality of life, degree of disability, treatment patterns and economic impact of hand and knee Osteoarthritis and Rheumatoid Arthritis in Mexico.

The osteoarthritis (OA) is a chronic and degenerative disease of multifactorial etiology, characterized by the gradual loss of articular cartilage. It is a question of one of the most common rheumatic disorders in the population, is the most habitual reason of pain and disability in the major adults and the first reason of surgeries of articular replacement. In Mexico, in a study of national area, the prevalence of locomotives manifestations was 26 %, with predominance in the women. Nowadays criteria exist for the classification of the OA, based on epidemiological studies, for the knee, the hip and the hand. Basically they have been established to homogenize studies of clinical epidemiological type. In other hand, the Rheumatoid Arthritis (RA) is an inflammatory, chronic, systemic disease that has more prominent manifestations in the diarthrodial joints. The disease have a wide range of characteristics, from the progressively chronic disease with variable degrees of destruction to articulate up to the extra-articular manifestations clinically evident. Demographically, the RA is the most common form of inflammatory arthritis and affects approximately 0.5 to 1 % of the world population, with an economic impact comparable with arterial coronary disease. The National Institute of Geographical Statistics (INEGI) thinks that in Mexico the population of major adults will double in the next decades, for what the impact of these rheumatic disorders will be serious and will turn into a problem of public health.

Based in the previous information, the Mexican Initiative of Patients with OA and RA (IMPACTAR), will on patient interview to increase the knowledge regarding the number of affected adults and the current treatment strategies.

This will be the first Mexican Registry related with Osteoarticular diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years with diagnosis of OA or RA according to the criteria of the American College of Rheumatology (ACR).

Exclusion Criteria:

* Patients with precedents of fractures; carrying patients of chronic diseases who limit them in the functional capacity.
CAR T Therapy With GCAR1 for Relapsed Alveolar Soft Part Sarcoma

A single patient study to determine whether GCAR1 is safe and effective for re-treatment of alveolar soft part sarcoma (ASPS) with GPNMB surface expression that has relapsed and is not responding to usual treatment.

CLIC-YYC-GPNMB-04 is an Open Label Individual Patient (OLIP)/Single Patient Study (SPS) developed according to the Health Canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. The patient under consideration for CLIC-YYC-GPNMB-04 has refractory, progressive metastatic alveolar soft part sarcoma (ASPS). There are no standard therapies for relapsed ASPS known to provide potential for cure, and there are no clinical trials available in Canada for consideration. We propose to re-treat the patient with GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB). The patient was previously treated with GCAR1 under CLIC-YYC-GPNMB-01 (c#276646).

Eligibility Criteria:
Inclusion Criteria:

* The patient must provide informed consent
* Adequate organ function, defined as creatinine clearance \>30 ml/min and LVEF \>45%

Exclusion Criteria:

* Any active uncontrolled infection
* Pregnancy or nursing
* Anti-cancer therapy within 21 calendar days prior to the first dose of lymphodepleting chemotherapy. If subject has received anti-cancer therapy, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy as per the discretion of the Qualified Investigator/Co-Investigator