cyrilzakka/clinical-trials huggingface dataset:
Prospective Psychometric Evaluation Study of a Patient-reported Outcomes (PRO) Instrument for Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP]

The purpose of this study is to assess the psychometric properties of a recently developed congenital thrombotic thrombocytopenic purpura (cTTP)-specific patient-reported outcomes (PRO) instrument.


Eligibility Criteria:
Inclusion criteria:

1. The participant is an adolescent aged 12 to 17 years or an adult aged ≥18 years;
2. The participant has been diagnosed with congenital thrombotic thrombocytopenic purpura (cTTP) and is currently receiving prophylactic or on-demand treatment with fresh frozen plasma (FFP), or solvent detergent (S/D) plasma, or Von Willebrand Factor/Factor VIII (VWF/FVIII) concentrates;
3. In the instance that the participant is identified and recruited remotely (Direct-to-Patient (DtP) recruitment), access to the internet and possession of an internet-connecting device is required;
4. The participant has provided informed consent, and in the instance that the participant is an adolescent, a legal guardian has provided informed consent and the adolescent has provided assent.

Exclusion criteria:

1. The participant cannot read nor write;
2. The participant is non-English speaking;
3. The participant is currently participating in a clinical trial.
Circulating Tumor Cell Genome in Peripheral Blood From Hepatocellular Carcinoma Patients Under Radiotherapy

Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients were presented with advanced disease. Percutaneous ethanol injection, radiofrequency ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a curative treatment and have achieved very limited success in eradicating large HCC or tumors causing portal vein thrombosis. With the development of novel radiotherapy (RT) technique, RT can be safely given to patients with larger tumor or portal vein thrombosis. However, RT could achieve a tumor response rate of approximately 50 %. Currently, there was a paucity of studies regarding a quantitative biomarker to predict tumor response or forecast the outcome in advance. To optimize the therapeutic index, there is a need to seek effective biomarkers for personal medicine because pretreatment AFP is not always useful as a surrogate marker in some of the patients.

The present study is to investigate whether circulating tumor cell genome in peripheral blood can be used to predict RT response in HCC. We will use the blood sample from patients with locally advanced HCC receiving RT. By using next generation sequencing, We are going to explore the quantity and quality changes of DNAs and RNAs in the patient's serum or plasma. By this way, genomic expression in peripheral blood may play a key role in determining the optimal therapeutic strategies for HCC patients by predicting tumor response to RT.

Patients with hepatocellular carcinoma requiring radiotherapy

Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable hepatoma with transarterial chemoembolization (TACE) failure or who are not suitable for TACE. A maximal tumor diameter \> 3.0 cm
* Age \> 20, and \< 80 years
* ECOG 0 or 1
* Life expectancy of at least 12 weeks
* Child-Pugh A
* Cancer of the Liver Italian Program (CLIP) score ≦ 3
* Pretreatment liver function test and renal function test:Total bilirubin \< 1.5 times the upper limit of normal (ULN), GOP/GPT ≦ 5 X of upper limit of normal range, Alkaline phosphatase ≦ 4X of ULN, Prothrombin time / partial prothrombin time \< 1.5 X of ULN, Serum Creatinine ≦ 1.0 x ULN
* Pretreatment blood count:Hemoglobulin ≧ 9 g/dl, Absolute neutrophil count ≧ 1500/mm3,Platelet count ≧ 100,000/mm3
* Subjects with at least one uni-dimensional or bi-dimensional measurable lesion and lesion must be measured by CT scan

Exclusion Criteria:

* Child-Pugh C
* CLIP score ≧ 4
* Patients with evidence of extrahepatic or metastatic disease
* Patients with evidence of massive ascites
* Patients receiving previous irradiation to liver
The Effects of Bariatric Surgeries on Glucose Metabolism

The purpose of this study is learn the effect of gastric bypass surgery and sleeve gastrectomy on glucose metabolism mediated by neural and hormonal factors initiated after eating.

The purpose of this study is to determine the weight-independent effects of gastric bypass surgery and sleeve gastrectomy surgery on islet cell response after meal ingestion as mediated by hormonal and neural components of the gut. It will also address the differences between the two procedures.

Such information will be critical for the development of novel approaches for treatment of diabetes as well as improvement of glycemic effects of gastric bypass and sleeve gastrectomy in patients with partial diabetes remission or relapse after complete remission.

Eligibility Criteria:
Inclusion Criteria:

* Hypoglycemic RYGB patients with documented blood glucose level \<50 mg/dl
* Asymptomatic individuals with bariatric surgery
* Healthy non-surgical patients with no personal history of diabetes
* Subjects must physically be able to come to our clinical research center Cedars-Sinai Medical Center

Exclusion Criteria:

* Active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high cholesterol; significant anemia (hemoglobin \<11g/dL); prisoners or institutionalized individuals; type 2 diabetes mellitis; development of any serious medical or psychiatric illness during recruitment or studies;
* RYGB patients will be disqualified if they have gastric outlet obstruction or severe diarrhea.
* Healthy non-surgical patients with personal history of diabetes

For administration of atropine, the following exclusions also apply:

* History of glaucoma
* Uncontrolled hypertension (any subjects with BP\>140/90 and history of dyslipidemia
* Taking any medication that might interact with atropine and cannot be stopped will be excluded from the study)
* Myasthenia gravis
* Brain pathology
* Enlarged prostate in men
Sun Protection Factor Assay (SPF Assay 204/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
ECMO for COVID-19 vs Influenza A H1N1 Associated ARDS

Objective: Veno-venous ECMO has been used as a rescue therapy for patients with severe ARDS associated to influenza A H1N1 and COVID19 viral pneumonia. Little is known about outcome of these patients who required extracorporeal support.

Research question: To compare outcome of patients who required VV ECMO for Covid19 and H1N1 associated ARDS


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 or influenza A H1N1 (suspected or confirmed) diagnosis
* Severe ARDS (according to Berlin Definition)
* VV ECMO
* Invasive mechanical ventilation through endotracheal tube or tracheostomy

Exclusion Criteria:

• Age\<18 years
Pedaling at a Low-Moderate Intensity During Chemotherapy Administration

The purpose of this study is to evaluate the feasibility of completing a low-moderate intensity pedaling session concurrent to chemotherapy treatment for colorectal cancer. Secondary objectives for this study consist of evaluating the role of pedaling on sarcopenia rates, quality of life markers, chemotherapy side effects, rate of hospital admissions, and treatment delays.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed colon or rectal cancer with previous surgical intervention and planned intravenous chemotherapy treatment (FOLFOX or FOLFIRI).
* ECOG Performance Status of Grade 0-2.

Exclusion Criteria:

* Limited functional status, demonstrated by an ECOG Performance Status of Grade 3-5.
* Severe cardiac history or comorbidities (i.e. have a cardiac defibrillator or have a history of heart failure, clinically significant aortic stenosis, cardiac arrest, uncontrolled angina, uncontrolled arrhythmias, major heart surgery, stroke, or pulmonary embolus).
* Chest pain or severe shortness of breath at rest or with physical activity.
* Orthopedic impediments to exercise (i.e. joint immobility or lower extremity lymphedema).
* Limitations to sustained exercise (i.e. bone metastases in the femur neck).
* Severe arthritis (i.e. osteoarthritis or rheumatoid arthritis).
Evaluation of the Noga System: Detecting of Respiratory Related Sleep Disorders in Cardiac Patients

Medical literature has shown that 1 out of 2 patients that are admitted to the hospital as a cardiac patient, will be found suffering from sleep breathing disorders. The medical literature also shows that there is an advantage of treating the sleep breathing disorders in addition to treating the cardiac disease or evaluating the heart failure condition to provide better clinical outcomes.this study is evaluating the ability to detect sleep and cardiac related breathing disordered.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is hospitalized in the cardiology department or in the sleep lab.
2. Patients who is willing and able to tolerate a full night Polysomnography
3. Patient is not receiving oxygen treatment
4. Patients is 18 years of age or above
5. Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form.

Exclusion Criteria:

1. Patients can not tolerate a full night Polysomnography.
2. Patient is receiving oxygen.
3. Participation in a clinical trial within the last 60 days and during the study.
4. Life expectancy \< 1 month.
Evaluate the Efficacy and Safety of One Course of Amevive in Taiwan Patients

An open-label, multicentre study to evaluate the efficacy and safety of one course of weekly intramuscular administration of Amevive in Taiwan patients with chronic plaque psoriasis

The purpose of the present study is to establish the efficacy and safety of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE in an alternate study population and to address the issue of peak time to response by measuring the proportion of patients achieving a ≥ 75% reduction in PASI at any time after completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent
* Must be \>= 16 years of age
* Must have been diagnosed with chronic plaque psoriasis at least one year and require systemic or phototherapy
* Must have CD4+ lymphocyte count at or above the lower limit of normal
* Must have a BSA \>= 10%

Exclusion Criteria:

* Current erythrodermic, generalized pustular, or guttate psoriasis
* Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
* History of any clinical significant disease that would be contraindicated for this study as determined by the investigator
* Prior history of systemic malignancy, untreated localised skin canceer or a \>10 squamous cell carcinoma
* Current enrollment in any other investigational drug study within 30 days prior to study drug administration
* Treatment with systemic immunosuppressant agents within the 4 weeks prior to study drug administration.
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003

ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.

ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258). The purpose of the study is to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. The desired primary efficacy outcome will be a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. The total duration of the study is up to 24 months including transition times, off drug intervals, and follow-up visits). It is expected that over a 16 week on drug interval menses will subside and return after a 4-8 week off drug interval (ODI).

Eligibility Criteria:
Inclusion Criteria:

* Completed the ZPU 003 study and met the inclusion/exclusion criteria of that study.

Exclusion Criteria:

* Low or high grade cervical dysplasia, as determined by Papanicolaou (PAP) smear.
* Pregnant or breastfeeding.
Mechanisms of COPD Exacerbation Recurrence

Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease. Patients with COPD are at increased risk of readmission to hospitals within the following 30 days. Hospital readmissions of COPD contribute to clinical and economic burden on society. Understanding why some COPD patients are readmitted remains a key area of unmet need.

To our knowledge, no previous study has fully investigated both the social and clinical risk factors associated with these types of patients. The investigators want to prospectively and comprehensively explore the possible causes, whether clinical or social factors, that cause rehospitalisation. The investigators will be collecting demographic and clinical information including daily physical activity level, lung function, blood and sputum samples. These measurements will be collected at patient admission, discharge and at follow-up of 30 and 90 days. This process could lead to a better understanding of the reasons which prevent early hospital readmission for those patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have a primary diagnosis of COPD
* Patients admitted to hospital with an exacerbation.

Exclusion Criteria:

* Patients in whom an initial diagnosis of an AECOPD is revised to an alternative at a later phase of the study.
* Patients who have a predominant history of asthma
* Patients with a confirmed active malignancy
* Patients who have a predominant history of bronchiectasis.
* Cognitive impairment patients with a Mental Test Score (MTS) of 6 or less.
* Inability to give informed consent to take part in the study
Myasthenia Gravis Registry in China

Myasthenia gravis (MG) is an autoimmune disease caused by dysfunction at the neuromuscular junction, characterized by partial or generalized skeletal muscle weakness and fatigability. The estimated annual incidence rate of MG in China is 0.68/100,000, with a high rate of relapse and poor treatment compliance. This study is a prospective, observational, multi-center patient registry across China. To support standardized management and follow-up of MG patients in China, a Cloud-based MG Patient Management Platform (CN MG Base) was established in September 2023 with the support of the Chinese Rare Diseases Alliance. The platform aims to collect longitudinal clinical data including demographic information, age of onset, medical history, comorbidities, medication usage, treatment responses, and others. It is intended to collect newly registered MG cases each year and follow up with these patients at one-year intervals for ten years

This study is a observational nationwide multicenter MG registry research. Starting from the baseline, annual follow-ups will be conducted to prospectively collect information on treatment medications, prognosis, and safety events. The following classification definitions can be applied: ① MG clinical subtypes (ocular, early-onset generalized, thymoma-related, late-onset generalized, MuSK-related, and seronegative); ② Different treatment methods (classic immunotherapy group, B-cell-targeted therapy, complement inhibition therapy, rapid-acting therapy, and IL-6 pathway inhibitors, etc.).

Eligibility Criteria:
Inclusion Criteria:

* Fluctuating weakness in skeletal muscles, such as extraocular, bulbar, limb muscles, etc.. Demonstrating fluctuation and fatigability: Weakness is usually worse in the morning and improves with rest; worsens with sustained activity.
* Patients themselves or their guardians can understand and sign the informed consent form.

To meet the eligibility criteria, at least one of the following additional criteria must be met:

* a. Positive Tensilon test;
* b. Decrease in compound muscle action potential by more than 10% with low-frequency repetitive nerve stimulation or widening of the "jitter" (the variability in time of the second action potential relative to the first) on single-fiber electromyography, with or without blocking;
* c. Positive antibodies: Serum testing positive for AChR antibodies, MuSK antibodies, or LRP4 antibodies.

Exclusion Criteria:

* Patients with mental illness who cannot cooperate.
* Patients with multiple organ dysfunction or in extremely critical condition, unable to complete relevant medical history collection or evaluation.
Clinical Evaluation of Multifocal Intraocular Lens: OPTIVIS.TM

This study evaluated visual outcome after cataract surgery with bilateral implantation of either a diffractive - refractive (hybrid) multifocal intraocular lens (MFIOL) or monofocal intraocular lens (IOL) as a control grup.

PURPOSE: To present the outcomes of hybrid multifocal and monofocal intraocular lenses (IOL)

SETTING: Parc de Salut Mar, Universidad Pompeu-Fabra - Autónoma, Barcelona, Spain.

DESIGN: Prospective clinical trial.

METHODS: Consecutive patients with bilateral cataract were included. Phacoemulsification with randomized implantation of either a monofocal IOL (AR40e, AMO-Abbot 30 Laboratories Inc. Abbot Park, Illinois, USA) or multifocal IOL (OptiVis™, Aaren Scientific, Inc, Ontario, CA, USA) was performed by the same surgeon and under the same conditions. Over a 3-month follow-up, the main outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity at 60 cm (UIVA), distance-corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity at 33 cm (UNVA), distance-corrected near visual acuity (DCNVA), spherical equivalent (SE), contrast sensitivity (CS), presence of dysphotopsia, use of spectacles and patient satisfaction with the test VF-14 (Visual Function Index) .

Eligibility Criteria:
Inclusion Criteria:

* senile cataract with Snellen visual acuity ≤ 0.5,
* motivation for spectacle independence for near vision (as the study was conducted in Spanish public health care system, entering study was the only option to get multifocal lens, as they are not provided by public health care, and the patients were conscious of the possibility of randomization to monofocal group.)

Exclusion Criteria:

* corneal astigmatism ≥ 1.10 diopters (D) and irregular astigmatism,
* axial length \< 21.5 or ≥ 25 mm,
* pupillary diameter in mesopic conditions in distance vision ≤ 2.5 mm and ≥ 6 mm,
* ocular pathology that could affect the visual function and/or intraocular lens centering and intraoperative or postoperative complications.
* highly demanding patients and those whose profession could be affected by a multifocal design (professional drivers, jewelers etc.) were also excluded (as in the Spanish public health care system secondary procedures needed to satisfy patients' expectation, such as LRI´s, LASIK, PRK´s, are not available).
EyeConic: Qualification for Cone-Optogenetics

This study aims to prepare for the first-in-human clinical trial of cone optogenetics vision restoration. As a first step, this worldwide multicenter ocular imaging study (EyeConic Study) is performed to identify eligible patients.

In a subset of patients with inherited retinal dystrophies (IRDs), cones lose their light-sensitive outer segments but remain alive in a dormant stage. This creates an opportunity to resensitize them through targeted optogenetic tools. However, the true proportion of low vision patients harboring dormant, non-functional cones, is currently unknown. The worldwide multicenter retrospective study (EyeConic) aims to estimate the proportion of low vision patients with remaining cone cell bodies for the first time.

Eligibility Criteria:
Inclusion Criteria (patients):

* Diagnosis of generalized IRD
* Low vision as defined as visual acuity worse or equal to 0.05 (or 20/400) in the study eye
* Availability of macular optical coherence tomography (OCT)

Inclusion Criteria (controls):

* Normal ophthalmic findings
* Availability of macular optical coherence tomography (OCT)

Exclusion Criteria (all):

* Other eye diseases with a significant effect on vision or retinal structure
* Extraocular disease affecting retinal structure such as neurodegenerative diseases
Safety Study of Zimura in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD

The primary objective is to assess the safety of intravitreal (IVT) Zimura® administered in combination with anti-VEGF Therapy (AVASTIN®, EYLEA®, OR LUCENTIS®) in anti-VEGF treatment experienced subjects with neovascular age-related macular degeneration (AMD)


Eligibility Criteria:
Inclusion Criteria:

* Treatment experienced subjects defined as subjects with 1 prior dose of same intravitreal anti-VEGF therapy given within the past 8 weeks for neovascular age-related macular degeneration (NVAMD) in the study eye. There must be \< 0 letters of improvement in Snellen (not ETDRS Snellen equivalent) visual acuity since the start of anti-VEGF treatment.
* Presence of subfoveal active choroidal neovascularization (CNV)

Exclusion Criteria:

* Intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication, with the exception of the 1 prior anti-VEGF injections.
* Presence of other causes of choroidal neovascularization, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
* Non-pharmacologic treatment (intraocular surgery or thermal laser) within three months of trial entry.
* Prior thermal laser in the macular region, regardless of indication.
* Ocular or periocular infection in the past twelve weeks.
* History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery, glaucoma drainage device, or corneal transplant.
* Previous therapeutic radiation in the region of the study eye.
* Evidence of diabetic retinopathy