cyrilzakka/clinical-trials huggingface dataset:
New, Previously Unknown, Uses of Optical Coherence Tomography Angiography (OCTA)

Sickle cell maculopathy was sparingly mentioned in the literature before despite the fact that sickle cell disease or sickle cell trait is common in people of many areas of the world. This study shows that OCTA is a very valuable, non invasive, office procedure that may well be used in diagnosing this disease.

this is a clinical study of two African Canadian patients that were diagnosed with sickle cell trait. I used OCTA to show macular vascular occlusions that usually happen with this disease.

Eligibility Criteria:
Inclusion Criteria: people with sickle cell trait or sickle cell disease -

Exclusion Criteria:

-
A Novel Fully Integrated Mobile Management Solution Using Cell Phone Technology for Heart Failure

The purpose of this research study is to learn about the use of a cell phone for monitoring patients with heart failure. Participants will be asked questions about their heart failure daily and participants will need to answer them. The investigator will try to assess if the questions are easily understood by the participants. The investigator will also assess if the phone-based system for monitoring is easy to use by the participants. The investigator will also assess if the daily questions and interactions increase the self-efficacy, knowledge, and quality of life of participants related to their heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of heart failure
* Have an anticipated survival ≥ 6 months
* Receive care at the University of Miami or Jackson Healthcare system
* 18 years or older
* Able to communicate in English and/or Spanish
* Able to operate a cell phone, read, understand, and respond to the questions on the cell phone, and are able to use the weight scale.

Exclusion Criteria:

* Previous history of unstable coronary syndromes
* History of end-stage heart failure or heart transplantation
p53 Gene Therapy for Head and Neck Malignant Tumors in Advanced Stage

This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent chemotherapy , with concurrent radiotherapy, or combination with surgery for treatment of head and neck malignant tumors in advanced stage .

Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with concurrent chemotherapy, with concurrent radiotherapy, or combination with surgery for treatment of head and neck malignant tumors in advanced stage (stage III or IV) including target lesion complete response rate (LCR) and overall target lesion response rate (OLR), response duration (RD), and progress-free survival (PFS).

The secondary objectives of this study is to investigate overall response rate (OPCR) and overall complete response rate (OCR), overall survival (OS), ECOG, and safety of rAd-p53 monotherapy and combined with chemotherapy, radiotherapy or surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Advanced stages of head and neck malignant tumors (stage III and VI)
2. At least one target tumor can be injected with study drug, the largest diameter greater than 2 cm
3. Histologically confirmed head and neck malignant tumors
4. No prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks
5. Age: 18-85 years old
6. Expected to survive more 12 weeks
7. ECOG:0-2
8. Neutrophils≥1.5×109/L,Platelet≥ 80×109/L, Hb≥80g/L, bilitubin≤2mg/dl,ALT and AST ≤2×institutional upper limit of normal, Cr ≤1.5×institutional upper limit of normal,coagulation tests (PTT and INR) within normal range
9. Subject provided signed informed consent

Exclusion Criteria:

1. Hypersensitive to study drug
2. Tumor(s) locate very close to important blood vessels and nerves, which affect injection
3. With a coagulation and bleeding disorder
4. With uncontrolled, intercurrent illness including but limited to symptomatic neurological illness, symptomatic congestive heart failure, unstable angina pectoris, significant pulmonary disease or hypoxia, or psychiatric illness
5. Local infection close to injection site or systemic infection
6. Pregnant or lactating
7. Principle investigator consider not suitable
Antibiotic Footprint Thailand - Pilot Questionnaire Study

Antimicrobial-resistant bacterial infection is an important cause of death in Thailand and in other countries worldwide. Increasing use of antibiotics in both animals and humans is one of the main drive that increase the incidence of antimicrobial resistant bacteria in human, animals and environment.

National Action Plan for Combating Antibiotic-resistant Bacteria aimed to have general population taking antibiotics less than 20% when they have common cold or diarrheal symptoms. However, there is little accurate information about behaviors of Thai people. Most studies were conducted in hospitals, clinics or pharmacy. Therefore, it did not include behaviors of those who had symptoms but did not present at hospitals, clinics or pharmacy.

In this study, the investigators aim to use questionnaire to Thai adult population to ask for the the amount of antibiotic used and the periods they had symptoms of common cold or diarrhea over one year period of year 2017. The main aim is to estimate the total antibiotic usage per human population, and plan for the study in the future.


Eligibility Criteria:
Inclusion Criteria:

The participant may enter the study if ALL of the following apply:

1. Participant is willing and able to give informed consent for participation in the study.
2. Male or female, aged 18 years or above.
3. Living in Thailand (staying in Thailand more than 6 months per year)

Exclusion Criteria:

None
Efficacy, Tolerability and Handling of Daivobet® Gel in Patients With Psoriasis Vulgaris

The purpose of this observational study is to evaluate the efficacy, tolerability, quality of life and handling of Daivobet® Gel by both physician and patient in daily practise.


Eligibility Criteria:
Inclusion Criteria:

* Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway

Exclusion Criteria:

* Previous therapy with Daivobet® Gel
* Systemic therapy of psoriasis vulgaris
* Contraindications of Daivobet® Gel in the German package insert
Repetitive Applications of Pruritogens and Effects of a Cutaneous-induced Pain Stimulation on Nonhistaminergic Itch Perception

In This experiment, the investigators would like to test following hypotheses:

the pain stimulation applied at the same time of a pruriceptive stimulus will decrease the itch perception. Moreover, also the effect of the cutaneous pain stimulus location (same forearm of the pruriceptive stimulus versus the opposite forearm) on histaminergic and non-histaminergic itch will be investigated.

The phenomenon that pain inhibits pain is a well-known mechanism, but it is not known if pain is inhibiting itch. In this context, the aim of this project is to investigate the extent to which thermal or neurogenic short cutaneous pain can affect the itch perception. In particular, the project aims to understand any differences in itch perception when the painful stimulation is applied on the same forearm versus the opposite forearm. The hypothesis is that by applying a painful stimulus at the same time of an itchy stimulus, the itch sensitivity will decrease; probably due to an inhibitory process conducted by interneurons (Bhlbb5 interneuron) at central level.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids, or other addictive drugs
* Previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis) musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder, or mental illnesses that may affect the results
* Lack of ability to cooperate
* Current use of medications that may affect the trial such as antihistamines, antipsychotics, and pain killers, as well as systemic or topical steroids
* Skin diseases (e.g. atopic dermatitis, pruritus nodularis, eczema, psoriasis)
* Moles, scars, or tattoos in the area to be treated or tested.
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.

The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Women with description of 2 or more years of Menopause;
* T-score \<= -2.0 sd;
* Confirmed colles'fracture;
* Independent for the march (preserved ambulatorial ability);

Exclusion Criteria:

* Co-morbidities;
* Regular use of corticosteroids or other anti-resorptive drug in the last year;
* Use of drugs that can affect the calcium metabolism;
* Hypersensitivity to risedronate;
* Previous wrist or forearm fracture;
* Hypocalcemia;
* Renal insufficiency;
* Rheumatic disease;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Does Active Parent Involvement in Deliberation and Choice Improve Medication Persistence for Their Child With ADHD

The purpose of the study is to determine whether active parent involvement in deliberation and choice improves subsequent medication persistence for their child with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ADHD based on DSM-IV criteria
* Enrolled in school-setting
* No learning disability
* No past use of psychoactive medication

Exclusion Criteria:

* Do not meet DSM-IV criteria for ADHD
* Not enrolled in school-setting
* Presence of learning disability
* History of brain injury
* Past use of psychoactive medication
Ga-68 FAPI PET Before Immunotherapy

It is aimed to evaluate FAP expression and its success in predicting treatment response before immunotherapy used in the treatment of malignant mesothelioma with Ga68 FAPI PET/CT imaging, which allows in vivo evaluation of FAP expression, which is thought to be associated with immunosuppression and resistance to immunotherapy.

Patients diagnosed with pleural mesothelioma and planned for immunotherapy will be included in the study. Patients will undergo Ga68 FAPI PET/CT imaging within 10 days before the start of immunotherapy treatment, and SUVmax, SUVmean, metabolic tumor volume and total Ga68 FAPI uptake parameters will be obtained from the tumors. Following this, the routine treatment and follow-up of the patients will be carried out by their clinicians. It will be evaluated whether there is a correlation between treatment response and initial Ga-68 FAPI PET findings.

Eligibility Criteria:
Inclusion Criteria:

* Having a histopathologically confirmed diagnosis of
* Pleural Mesolthelioma
* Patients scheduled for immunotherapy with anti-PDL-1 and/or anti-CTLA-4 antibodies as first or second line therapy
* Patients who gave informed consent form to participate in the study

Exclusion Criteria:

* ECOG\>2
* Patients who did not provide informed consent form to participate in the study
A Study of ATG-010 in Combination With ATG-008 in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

This is an Open label, Phase Ⅰb Study of ATG-010 in Combination With ATG-008 in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)

This is a multi-center, open label, phase 1 study conducted in RR DLBCL patients. The MTD and/or RP2D of study treatment, ATG-010 in combination with ATG-008, will be selected using BOIN design for the dose escalation phase. Additional patients will be enrolled as an expansion cohort after MTD and/or RP2D is determined.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old.
2. ECOG Performance score of ≤2.
3. Estimated life expectancy of \>3 months.
4. Previously treated, pathologically confirmed DLBCL
5. Patients must have received at least 2 but no more than 5 previous systemic regimens (for non-DH/TH, non-DE DLBCL and DLBCL not transformed from FL or CLL), or at least 1 but no more than 5 previous systemic regimens (for DH/TH, DE DLBCL, and DLBCL transformed from FL or CLL) for the treatment of their DLBCL.

   1. Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy.
   2. Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of therapy.
   3. Any maintenance therapy will not be counted as a separate line of systemic therapy.
   4. Radiation with curative intent for localized DLBCL will not be counted as 1 line of therapy
6. Documented radiographic evidence of progressive DLBCL of the last line (or refractory DLBCL) prior to the first dosing.

Exclusion Criteria:

1. Female patients who are pregnant or lactating
2. DLBCL with mucosa-associated lymphoid tissue \[MALT\] lymphoma, or primary mediastinal (thymic) large B-cell lymphoma (PMBL)
3. Known central nervous system lymphoma or meningeal involvement (for dose expansion phase, patients with stable CNS disease could be considered).
4. Patients eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (the Investigator must provide detailed documentation for ineligibility)
5. Use of any standard or experimental anti-DLBCL therapy (including radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) \<21 days prior to Cycle 1 Day 1.
6. Autologous stem cell transplant (SCT) \<6 months or prior allogeneic SCT, or CAR-T cell infusion \<6 months prior to Cycle 1.
7. Major surgery within 4 weeks of the first dose of study treatment.
A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
* Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion Criteria:

* Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients.
* Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.
Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients

This research proposal has two main objectives. The first is to increase understanding of the underlying physiological interactions that occur between the cardiovascular, pulmonary, and ANS during transition between positive pressure mechanical ventilation (MV) and spontaneous breathing. The second is to determine if heart rate variability, (HRV) a reflection of autonomic nervous system (ANS) activity, and autonomic information flow (AIF), a set of nonlinear measures derived from HRV, both measured in the intensive care unit (ICU) can predict patient outcomes including successful weaning and in-hospital recovery time after an episode of cardiopulmonary compromise requiring MV.

Hypothesis 1. Transitions between mechanically supported ventilation and spontaneous breathing will disturb cardiovascular synchrony, altering the relationship of HRV, AIF, respiratory rate, and blood pressure;

Hypothesis 2. More normal HRV and AIF values, measured during baseline MV and sedation awakening (a period immediately prior to SBT when sedative medications are discontinued) will be associated with easier weaning, and shorter intensive care unit (ICU) and hospital lengths of stay; more abnormal measurements will be associated with longer lengths of stay;

Hypothesis 3. AIF is a more sensitive predictor of successful weaning from MV than HRV.


Eligibility Criteria:
Inclusion Criteria:

* Receiving mechanical ventilation in medical-surgical intensive care unit;
* Eighteen years of age or older;
* Expectation of receiving initial spontaneous breathing trial within the next 24 hours.

Exclusion Criteria:

* Pregnant;
* Expectation of non-survival when ventilator is discontinued;
* Cardiac rhythm of atrial fibrillation;
* Paced cardiac rhythm.
Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis

To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
* Functional Capacity Classification of I-III

Exclusion Criteria:

* Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
* Received acetaminophen within 24 hours of the baseline visit
* Acute joint trauma at index joint within the past 3 months with active symptoms
* History of gastrointestinal (GI) perforation, obstruction, or bleeding
* Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
* Received corticosteroids or hyaluronic acid within certain timeframe before study
The Clinical Application of Clostridium Butyricum Miyairisan for Motor and Non-motor Symptoms in Parkinson's Disease

This is an open-label, single-center, non-randomized study to assess the efficacy of Clostridium Butyricum Miyairi on the motor and non-motor symptoms of Parkinson's disease

The physician will explain the trial procedures in the outpatient, and then obtain the written informed consent to start the interview. And randomly divided into experimental and observation groups, and according to the timing of taking Miyarisan, scale evaluation and sample collection.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 20 years old, diagnosed with Parkinson's disease.

Exclusion Criteria:

* People with Parkinson's disease Dementia, or Lactose Intolerance
Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects

A crossover study to assess the effect of repeated doses of fostamatinib on the levels of oral contraceptive (Microgynon® 30) in the blood of healthy female subjects. The study will consist of a screening period of up to 35 days, followed by 2 treatment periods (28 days each) of an oral contraceptive (Microgynon® 30) in the absence and presence of fostamatinib. The study will also evaluate the safety and tolerability of fostamatinib in combination with an oral contraceptive


Eligibility Criteria:
Inclusion Criteria:

* Female subjects of age 18 to 45 years, inclusive, who are healthy, non-pregnant, not planning pregnancy within the study period
* Willing to use a highly effective method of birth control, ie, double barrier method contraception (condom and diaphragm with spermicide) from the first day of Period 1 until 28 days after the last dose
* Body weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive
* Two negative pregnancy tests at least 7 days apart

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History or presence of Gastrointestinal, hepatic, or renal disease
* Any condition listed as a contraindication in the Microgynon® 30 labelling
* Absolute neutrophil count less than 2.5 x 109/L.
Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room

Objectives:

1. To compare the immune response of patients with or without sepsis presenting to the ED with a(n) (suspected) infection.
2. To determine immune response aberrations that are associated with an increased risk of developing sepsis in patients presenting to the ED with a(n) (suspected) infection without sepsis.
3. To determine the long term cognitive and physical sequelae of sepsis after admission.

Sepsis will be defined in accordance with the current Sepsis 3.0 criteria as a(n) (suspected) infection with evidence of organ failure, as reflected by a SOFA (Sequential Organ Failure Assessment) score of ≥2. Notably, a molecular definition of sepsis does not exist and there is no pathological gold standard; therefore, in accordance with the current international consensus, the investigators consider the commonly used clinical organ failure (SOFA) criteria as the best option. The SOFA score is composed of six organ dysfunctions (cardiovascular, pulmonary, renal, hepatic, coagulation and neurological). The SOFA score was developed for ICU patients, but its components can be easily scored in an ED (and hospital ward) setting with the exception of the pulmonary component; this pulmonary dysfunction score is based on the PaO2/FiO2 (PF) ratio, wherein PaO2 is the partial pressure of oxygen in arterial blood and FiO2 the fraction of inspired oxygen. Measurement of the PaO2 requires an arterial blood puncture, which is not routinely done on the ER or hospital ward. Therefore, the investigators will use an alternative method to determine the respiratory SOFA by determining the SpO2/FiO2 (SF) ratio, wherein SpO2 is peripheral oxygen saturation. SpO2 is routinely measured by finger pulse oximeter in patients with suspected infection; FiO2 is 21% when breathing room temperature and increases by 4% with each liter of oxygen provided per minute to a patient via a nasal cannula. Cut-off values for SF ratios correlating with SOFA pulmonary scores based on PF ratios have been validated in large data sets.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or higher
* Presentation at the Emergency Department (ED)
* Clinical suspicion of infection or earlier confirmed infection
* Modified Early Warning Score (MEWS) of 2 or higher

Exclusion Criteria:

* No informed consent given