cyrilzakka/clinical-trials huggingface dataset:
Unveiling Preclinical Idiopathic Macular Hole Formation

A macular hole is a rupture in the macula. In terms of pathogenesis, as much as 80% are idiopathic (Idiopathic Macular Hole, IMH). The normal incidence of this condition is about 0.17%; however, there is a 10-29% chance of development of a macular hole in the fellow eye of patients suffering from unilateral macular hole.

Our hypothesis is that embedded in the topography of the retina is information that can allow for discrimination between healthy eyes and eyes with an increased risk of developing IMH. As such, our work aims to develop a system that allows the automatic identification of these eyes.

A macular hole is a rupture in the macula, the central portion of the retina, responsible for sharp, central vision and hence indispensable for most tasks. In terms of pathogenesis, even though some can be related to trauma, as much as 80% are idiopathic (Idiopathic Macular Hole, IMH). It is theorized that antero-posterior and tangential forces are behind this condition; however, no conclusions have been reached. While the normal incidence of this condition is about 0.17%, there is a 10-29% chance of developing a macular hole in the fellow eye of patients suffering from unilateral macular hole.

Our working hypothesis is that embedded in the topography of the retina is information that can allow for discrimination between healthy eyes and eyes with an increased risk of developing IMH. As such, our study consists on the characterisation of the retinal topography of fellow eyes of patients with unilateral IMH but no other visible retinal pathologies, and of eyes from controls subjects in the same approximate age group. From these topographic maps we acquire a series of features (parameters), and using machine learning techniques create a system that separates eyes into one of the groups - healthy or at risk.

Eligibility Criteria:
Inclusion Criteria:

* normal OCT, with or without vitreous adhesion
* fellow group: unilateral idiopathic macular hole

Exclusion Criteria:

* OCT with vitreous adhesion
* lamellar or pseudoholes
* inner retinal surface alterations
* myopia(\>4D)
* glaucoma
* significative media opacity
* previous retina photocoagulation
* any type of intraocular surgery in the last 6 months
* intravitreal medication
* diabetes or neurodegenerative diseases
* macular hole secondary to trauma
Complicated Appendicitis During the COVID-19 Pandemic in Jordan

Comparing the incidence of complicated appendicitis between two groups, the pandemic and pre-pandemic groups.

The investigators have retrospectively investigated data on acute appendicitis cases. Two groups were established, the first group was the pandemic group, which included patients who presented to the hospital during the period of acute restrictions and shutdowns extending from the 17th of March to the 6th of June 2020, and the pre-pandemic group which represents the same period in the previous year, the aim was to assess the incidence of complicated appendicitis during the COVID-19 pandemic in Jordan University Hospital

Eligibility Criteria:
Inclusion Criteria:

* Any patient that presented with appendicitis and underwent an appendectomy at the university of Jordan hospital during the specified time periods (March 2019-December 2020)

Exclusion Criteria:

* Incomplete data record.
SCH 727965 in Patients With Mantle Cell Lymphoma or B-Cell Chronic Lymphocytic Leukemia (Study P04715)

Participants will be randomized to SCH 727965 or a comparator drug (bortezomib for mantle cell lymphoma \[MCL\] or alemtuzumab for B cell chronic lymphocytic leukemia \[B CLL\]). Part 1 of the study will determine the activity of SCH 727965 treatment in participants with MCL and participants with B-CLL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants who experienced disease progression after standard treatment with the comparator drug during Part 1.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years, either sex, any race.
* Eastern Cooperative Oncology group performance status of 0 or 1.
* Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
* For subjects with MCL:

  * Diagnosis of MCL according to the World Health Organization (WHO) criteria.
  * Received at least one prior chemotherapeutic regimen, but no more than two regimens including stem cell transplantation..
  * Measurable or assessable disease by the Revised Response Criteria for Malignant Lymphoma.
* For subjects with B-CLL

  * Documented B-CLL according to the National Cancer Institute Working Group (NCI-WG) criteria.
  * Received at least one prior alkylating agent-based regimen and one fludarabine- or pentostatin-containing regimen, but must not have received more than two prior regimens.
  * Measurable or assessable disease by NCI-WG criteria.

Exclusion Criteria:

* Known central nervous system involvement of MCL or B-CLL.
* Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.
* For MCL, previous treatment with bortezomib.
* For B-CLL, previous treatment with alemtuzumab.
* Known HIV infection.
* Known active hepatitis B or C.
Engaging Diverse and Underserved Communities in Cancer Awareness Training and Education

The University of California Davis, Comprehensive Cancer Center's (UCDCCC) Office of Community Outreach and Engagement (OCOE) serves the 19 catchment counties which approximately consists of 5 million residents. Currently, the overall catchment population cancer screening rates fall below 80%. The aim of OCOE is to increase cancer education (prevention, screening, and vaccination) and training. Through education, and encouraging participation in routine screening for early detection, this can help increase cancer knowledge. In addition to cancer education, OCOE wants to educate community members regarding modifiable risk factors which include tobacco usage, being overweight/obese (physical inactivity/poor nutrition), and lack of immunizations. By increasing knowledge of cancer prevention, screening, and vaccination this will help community members become more aware of their cancer risk.

Objective: To determine the effects of health education, outreach, and training activities on cancer control and prevention knowledge, attitudes, beliefs, and behaviors among the University of California Davis, Comprehensive Cancer Center's (UCDCCC) catchment area residents. There are 3 Specific Aims for EDUCATE.

Specific Aim 1: To educate catchment area residents on modifiable risk factors for cancer (e.g., screening, behavior, vaccination) and the importance of participation in cancer research.

Specific Aim 2: Provide participants with educational materials on cancer prevention, screening, and vaccination.

Specific Aim 3: Evaluate the effectiveness of the health education, outreach, and training through the analyses of quantitative and qualitative data collected from the health education activities.

Eligibility Criteria:
Inclusion Criteria:

* UCDCCC (University of California, Davis Comprehensive Cancer Center) Catchment Area Population

Exclusion Criteria:

* Above age 80
Bioavailability of Increasing Pramipexole Doses of Oral Extended Release (ER) Tablets in Healthy Male Volunteers

The objectives of the studies are:

* To demonstrate similar total exposure between pramipexole ER fasted and pramipexole ER fed after multiple administration of the highest daily dose of 4.5 mg q.d. and to reveal any food effect leading to uncontrolled release
* To investigate the relative bioavailability of the ER-formulation of pramipexole in comparison to the IR-formulation at the highest daily dose of 4.5 mg after multiple dosing
* To demonstrate dose proportionality between the dose strengths of the pramipexole ER formulation of 0.375, 0.75, 1.5, 3.0, and 4.5 mg after multiple daily (q.d.) dosing


Eligibility Criteria:
Inclusion Criteria:

* All participants in the study should be healthy males
* Age range from 21 to 50 years
* Body mass index (BMI) be within 18.5 to 29.9 kg/m2
* In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (≤ one month prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on in-house trial days
* Alcohol abuse (\> 40 g/day)
* Drug abuse
* Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the clinically accepted reference range
* Excessive physical activities within the last week before the trial or during the trial
* Hypersensitivity to pramipexole, or other dopamine agonists
* Supine blood pressure at screening of systolic \< 110 mmHg and diastolic \< 60 mmHg
Effects of Altitude on Single-Breath Diffusing Capacity for Carbon Monoxide

The purpose of this study is to further understand the effects of altitude on the physiology of gas exchange in the pulmonary microcirculation in normal subjects and in people with chronic obstructive pulmonary disease (COPD) measured as the single-breath diffusing capacity for carbon monoxide (DLCOsb). The study will determine a mathematical formula to allow for altitude corrections in both study populations to be used clinically in pulmonary labs.

The DLCOsb is one of the most common and widely tests clinically used across the world in pulmonary function laboratories to assess gas exchange from the lung to hemoglobin in the pulmonary circulation. This test is used in the differential diagnosis of respiratory related symptoms, to grade the degree of severity in lung disease, and to objectively monitor the progression of disease or the response to therapies. Therefore, it is important to have standard methods of performing and interpreting this test.This is a prospective study, collecting data from subjects at different simulated altitudes. The study hypothesis is that increasing altitude will increase the DLCOsb in a predictable manner that will allow for mathematical corrections to be applied for uniform interpretation in pulmonary labs at differing altitudes.

Eligibility Criteria:
Inclusion Criteria:

* Ages 20- 80 years
* Subjects must be either healthy or have been diagnosed with COPD

Exclusion Criteria:

* Anemia (hemoglobin \< 10.0 g/dL)
* Carboxyhemoglobin \> 3%
* Active smoking
* Heart disease or heart failure
* Pulmonary hypertension
* COPD exacerbation
* Pneumothroax within 6 months
* Bullous emphysema on chest imaging (Chest X-ray or CT)
* Supplemental oxygen use
* Diabetes mellitus
* Alcohol dependence
* Non-English speaking
Once Weekly D-cycloserine for Schizophrenia

This is a parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 4, \& 8 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in adult outpatients with schizophrenia.

In a previous placebo-controlled trial, investigators demonstrated significant improvement of negative symptoms with once-weekly D-cycloserine treatment. In addition, investigators found significant improvement of memory consolidation following the first dose; however, the effect on memory consolidation was lost after several weeks. The "practice effect" of weekly measurement of memory consolidation using repeated administration of the Logical Memory Test may have resulted in a "ceiling effect" which would obscure drug/placebo differences. In the current study, investigators propose to administer the Logical Memory Test at four-week intervals (weeks 1, 4 and 8) to avoid the ceiling effect. Additionally a measurement will be added of negative symptoms at week 4 to better characterize the time course of negative symptom improvement.

Hypotheses:

1. Assess the effects of a single dose of D-cycloserine 50 mg on memory consolidation as measured by the Logical Memory Test compared to placebo.
2. Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 \& 8.
3. Assess the effects of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery at week 8 compared to placebo.
4. Assess effects of weekly D-cycloserine dosing on negative symptoms at weeks 4 \& 8 compared to placebo.
5. Assess tolerability and side effects of weekly D-cycloserine compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Age 18-65 years
3. Diagnosis of schizophrenia or schizoaffective disorder, depressed type
4. Stable dose of antipsychotic for at least 4 weeks.
5. Able to provide informed consent
6. Able to complete a cognitive battery

Exclusion Criteria:

1. Current treatment with clozapine
2. Dementia
3. Seizure disorder
4. Unstable medical illness
5. Active substance abuse
6. Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
7. Severe renal insufficiency (Serum creatinine \> 1.5 mg/dL)
Electroacupuncture on Post-stroke Urinary Retention

This study aimed to evaluate the effectiveness of adjuvant electroacupuncture therapy for the post-stroke patients with urinary retention under conventional treatments, compared with sham electroacupuncture.


Eligibility Criteria:
Inclusion Criteria:

* male or female aged over 19
* Patients diagnosed with stroke (cerebral hemorrhage or infarction) based on the CT or MRI examination
* Those whose onset is within 2 years
* Those who have urinary retention after stroke onset (every PVR result is equal or more than 100ml on the 2 consecutive tests)
* Those who signed on the informed consent form

Exclusion Criteria:

* Patients who have any bleeding disorders based on medical history hearing
* Patients who have ever had any medical procedures or surgeries for peripheral vascular diseases based on medical history hearing
* Patients who have any psychiatry disorders based on medical history hearing
* Patients who have any severe diseases in lower urinary tract symptom based on medical history hearing
* Patients who have any acute or chronic infectious diseases in lower urinary tract symptom based on medical history hearing
* Acute stage stroke patients (onset within 1 week) whose Glasgow Coma Scale ≤ 8
* Patients who have fear about acupuncture
* Patients who have changed medications for urinary retention or relevant symptoms, such as urinary incontinence drugs or diuretics, within 3 days
* Female who diagnosed with pregnancy by urinalysis
* Those who primary or sub investigators judge not to be suitable for the study
Metabolic Exercise Testing

Exertional symptoms are the hallmarks of metabolic myopathies, supporting the concept of using functional tests when this diagnosis is suspected. Exercise increases the concentration of muscle metabolites in the venous blood supply (e.g. lactate, pyruvate, and ammonia) especially during recovery. The purpose of this study is to compare the results of exercise testing with to the data from muscle biopsy or genetic analysis.


Eligibility Criteria:
Inclusion Criteria:

* Referred to the Physiology Department of Brest Hospital for a metabolic exercise test
* Ability to provide informed consent

Exclusion Criteria:

* Contraindication(s) to perform cardiopulmonary exercise testing (ATS/ACCP statement on cardiopulmonary exercise testing, Am J respi Care Med 167: 211-77, 2003)
* Pregnancy or unknown pregnancy status.
Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty

Assessment of safety and efficacy of tissue-engineered corneal endothelial graft material generated using cultured human corneal endothelial cells for tissue-engineered endothelial keratoplasty (TE-EK).

The specific aim of this clinical trial is to assess the clinical efficacy and safety outcomes of patients receiving Tissue-Engineered Endothelial keratoplasty (TE-EK) graft material generated from human corneal endothelial cells (HCEnCs) propagated in a regulatory-approved dual media approach. Post-operative follow-ups and visits will follow current EK protocols of Singapore National Eye Centre. Clinical assessments include postoperative visual acuity, intraocular pressure, keratometric astigmatism, spherical equivalent, endothelial cell density, anterior segment optical coherence tomography (ASOCT), contrast sensitivity, as well as any postoperative complications such as graft dislocation or primary graft failure.

Eligibility Criteria:
Inclusion Criteria:

Patients who have mild to moderate corneal endothelial decompensation or bullous keratopathy, but with minimal corneal stromal scarring resulting from a variety of conditions including:

* Fuchs' endothelial dystrophy
* Post-surgical corneal decompensation (irreversible) - all forms of pseudophakic or aphakic bullous keratopathy

Exclusion Criteria:

* Severe forms or late stage presentation of corneal decompensation with severe corneal stromal scarring, unsuitable for TE-EK surgery as opposed to penetrating keratoplasty
* Patients with complex anterior segment complications precluding a successful TE-EK procedure
* Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation
* Post-laser iridotomy or glaucoma related corneal decompensation
* Patients not keen to participate in the clinical trial
* Patients who are below 21 years of age or above 80 years of age
* Patients who are pregnant
* Patients who are cognitively impaired
* Patients who are prisoners
* Patients who are allergic to antibiotics
Diabetes Therapy to Improve BMI and Lung Function in CF

To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).

The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes without fasting hyperglycemia.

Eligibility Criteria:
* Diabetic glucose pattern by oral glucose tolerance test (OGTT) of \>200 at 120 min. (stable and healthy at time of OGTT)
* Fasting glucose levels \<126.
* Weight stable within 5% in previous 3 months.
* Free from illness for two months.
* Male and female 16 and older, who are done growing
* Willing to come in for visits every 3 months.
* Patients receiving infrequent short bursts of systemic glucocorticoids may be considered for the study inclusion if: a. they have not received systemic glucocorticoids steroids for at least one month, b. they did not receive the steroids for more than 14 consecutive days or 28 days total in six months
Removal of Ligand-bound Iron During Intravenous (IV) Iron Administration in Hemodialysis (HD)

The study's hypothesis is that HD with large pore dialyzers remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis.

Most hemodialysis(HD) patients receive during HD intravenous iron compounds, which are composed of an iron core and a sugar polymer shell.

A small percentage of iron from the iron compound is released to the plasma, and may be associated with increased oxidative stress and protein oxidation. The study's hypothesis is that HD with large pore dialyzers may remove to the dialysate iron which is bound to potentially dialyzable ligands, after it's release from intravenous iron compound administered during hemodialysis.

Ligand-bound iron removal is also hypothesized to be affected by dialysate calcium and bicarbonate concentrations, which may affect iron-ligand binding.

Study Specific aims are:

To evaluate

1. Iron removal assessing dialysate iron levels.
2. Effect of iron removal and it's associated experimental conditions on patient status, assessing plasma AOPP levels and inflammation related parameters

Study include 3 parts

1. Comparing large to small pore dialyzers

   (To achieve baseline uniform conditions, patients will be on uniform dialysate bicarbonate and calcium concentrations of 33 mEq/L and 3 mEq/L,respectively, using large pore dialyzers during this part, besides the 2 HD sessions evaluating low pore dialyzers)

   and after few week break

   Using large pore dialyzers to compare
2. Low to high dialysate bicarbonate concentration (using uniform dialysate calcium concentrations of 3 mEq/L)

   and after few week break
3. Low to high dialysate calcium concentrations concentration (using uniform dialysate bicarbonate of 33 mEq/L)

In each part, patients will be first evaluated in HD without IV iron administration, which will serve as a control for evaluation after a week in HD with IV iron administration.

In each part, patients will be randomized to start either with one of the 2 experimental conditions, and after 1 week without evaluation will cross-over to the other experimental condition.

Patients may participate in 1,2 or the 3 parts of study depending on their will and condition.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patients

Exclusion Criteria:

* Acute disease (infection, thrombosis, ischemia, bleeding) Hepatitis B, Hepatitis C or HIV
* Intravenous iron administration or packed red cell transfusion in the last 3 weeks prior to the study
* Refusal to comply with limitations in fat containing food during HD with plasma sampling for AOPP evaluation