cyrilzakka/clinical-trials huggingface dataset:
Preventing Depression in Patients With Macular Degeneration

This study will evaluate the effectiveness of a Problem Solving Treatment in preventing depression in elderly patients with age-related macular degeneration (AMD).

AMD is the most common cause of blindness in older adults. The disease limits the ability to read, see familiar faces, and walk independently. Almost 2 million persons (about 5 percent of the U.S. population over age 65) are now affected, and this number will triple by the year 2020. This study will target patients with neovascular AMD (NV-AMD), a form of AMD which can lead to sudden vision loss, substantial disability, and depression. Because depression is itself disabling and not likely to be recognized nor treated by ophthalmologists, preventing depression in people with NV-AMD is important.

Patients are randomly assigned to either PST or a usual care control condition. The primary outcome measure is a DSM-IV diagnosis of depression. Patients are evaluated at baseline, Month 2 (immediately post-intervention), Month 6 (for the primary efficacy analysis), and Month 12 (to evaluate sustained effects). The study will also assess the impact of PST on levels of disability and vision-related quality of life.

Eligibility Criteria:
Inclusion criteria:

* Bilateral macular degeneration
* Visual acuity of 20/40 or worse in better eye
* Residence within 40 miles of Wills Eye Hospital in Philadelphia, PA
Use of Procalcitonin in the Diagnosis of Pleural Effusion

Among several markers of inflammation and sepsis, procalcitonin (PCT) markers is being studied to investigate their accuracy for the diagnosis of bacterial infections. PCT is the prehormone of calcitonin, which is normally secreted by the C cells of the thyroid in response to hypercalcemia; under these normal conditions, negligible serumPCT concentrations are detected. The mechanism proposed for PCT production after inflammation and its role are still not completely known. It is believed that PCT is produced by the liver and peripheral blood mononuclear cells, modulated by lipopolysaccharides and sepsis-related cytokines. It binds to polysaccharides in pathogens, activating the classical complement pathway. The reported diagnostic accuracy of PCT for the diagnosis of bacterial infections has varied across studies.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of pleural effusion
* Pleural effusion proved by chest sonography

Exclusion Criteria:

* Conditions for which thoracentesis are contraindicated
* Pregnancy
Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis

This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve the rate of complete hematological response.

This is a single-arm, multi-center, prospective study. Participants will receive the single drug teclistamab, which the investigator deems the best choice.

The treatment of amyloidosis should focus more on complete hematological response (CHR) and organ response rate. We hypothesize that teclistamab can deeply eliminate cloned plasma cells in AL patients, achieving a high proportion of complete hematological response.

In clinical practice, if daratumumab, bortezomib, and venetoclax (for patients with t(11;14)）have been used, the outcome is poor. Also, CHR is correlated with better clinical outcomes. In clinical routine practice, we use teclistamab, a more effective treatment to eliminate clonal plasma cells.

To further explore efficacy and safety, we designed this prospective study.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of systemic AL amyloidosis;
2. Patients must have received standard-of-care daratumumab, bortezomib, they do not have at least one organ response, and have not get complete hematological response;
3. Life expectancy greater than 12 weeks;
4. HGB ≥70g/L;
5. Blood oxygen saturation \> 90%;
6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
7. Informed consent explained to, understood by and signed by the patient.

Exclusion Criteria:

1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
3. Severe or persistent infection that cannot be effectively controlled;
4. Presence of severe autoimmune diseases or immunodeficiency disease;
5. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
6. Patients with HIV infection or syphilis infection;
7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer

The purpose of this study is to evaluate the safety and tolerability of a high dose of vitamin D (VD) in patients with cirrhosis. The investigator hypothesizes that high dose VD will be safe and well-tolerated in adults with cirrhosis, and will inhibit the inflammatory and proliferative events that cause progression of cirrhosis to hepatocellular carcinoma.

This study will be done in two phases. The first phase is being done to find the highest dose of VD that can be tolerated, in other words taken without causing severe side effects. The second phase is a 6 month treatment with the dose determined to be safe in the first phase, to investigate general health benefits and the potential to reduce the development of Hepatocellular carcinoma (HCC), also known as liver cancer. Improvement of general health will be determined by interviews with patients, markers in the blood for response to VD, bone remodeling, inflammation, and evidence of HCC on routine imaging.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects between the ages of 18 and 75 with cirrhosis of any etiology followed at the Georgetown Transplant Institute, Washington, DC, will be offered entry into this study. The diagnosis of cirrhosis will be based on clinical, imaging or histological studies.
2. No evidence of HCC on entry imaging study ( if liver nodules are present, these should be classified as LIRADS 1-3 only).
3. Model for End Stage Liver Disease (MELD) score under 22 (a MELD score over 22 would predict a 3 month mortality rate of approximately 20%).
4. Not currently participating in another intervention study.
5. Not pregnant or lactating, and willing to use effective contraception during study period.
6. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
7. Ability to provide written informed consent according to national/local regulations

Exclusion Criteria:

1. Any diagnosis of kidney stones
2. A diagnosis of granulomatous diseases (e.g., sarcoidosis), active chronic fungal or mycobacterial infections (e.g., tuberculosis, histoplasmosis, coccidioidomycosis, blastomycosis, berylliosis, or Wegener's granulomatosis) in the past 6 months
3. A diagnosis of hyperparathyroidism or other serious disturbance of calcium metabolism in the past 5 years
4. A diagnosis of severe kidney disease, e.g., chronic renal failure, in the past 6 months
5. A diagnosis of unexplained hypercalcemia in the past 6 months
6. Any diagnosis of osteoporosis with physician recommendation for treatment of low bone mass
7. A diagnosis of two or more low trauma fractures in the past 6 months
8. A diagnosis of a medical condition requiring treatment with VD (e.g., osteomalacia) in the past 6 months
PALISADE Follow-on Study (ARC004)

The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study.

This is an international, multicenter, open-label, 2-arm follow-on study of the safety, tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the ARC003 study. This study will explore alternative dosing regimens during extended maintenance with AR101.

Eligibility Criteria:
Key Inclusion Criteria:

* Completion of the ARC003 study
* Written informed consent and/or assent from subjects/guardians as appropriate
* Use of effective birth control by sexually active female subjects of child-bearing potential

Key Exclusion Criteria:

* Early discontinuation from the ARC003 study
* Meets any longitudinally applicable ARC003 study exclusion criteria
* (Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC
* Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Trial Comparing PLA to HIGRT (PROVE-HCC)

This phase II, randomized trial compare Quality of Life for patients with Hepatocellular Carcinoma (HCC) who are not surgical candidates or decline surgery and are treated with Percutaneous Local Ablation (PLA) or Hypofractionated Image-Guided Radiation Therapy (HIGRT).

Administrative clarification:

This clinical trial was terminated due to poor enrollment and was replaced by a separate non-randomized trial (NCT04933435).

Eligibility Criteria:
Inclusion Criteria:

* HCC diagnosed either by histology/pathology or Liver Imaging Reporting and Data System (LIRADs 5 per the ACR's LIRADs criteria) by CT or MRI
* Patient is 18 years or older
* ECOG Performance status of 0-2
* Child Pugh score A5, A6, B7 or B8
* Lesions less than or equal to 5cm in size
* Less than or equal to 3 lesions in the liver to be treated on protocol
* Lesion amenable to treatment with both PLA and HIGRT; for PLA treatment this requires the lesion be visible via ultrasound and/or non-contrast CT or feasible per treating physician

Exclusion Criteria:

* Child Pugh score B9 or Class C
* Fluctuating ascites
* Inability to complete baseline QOL forms
* Concurrent administration of systemic therapy for HCC
* Prior liver RT is an exclusion unless subject participation is approved by the PI
* Positive serum pregnancy test
Epidemiology of Sepsis at Yuetan Subdistrict in Beijing

The purpose of this study is to determine the epidemiology and outcome of sepsis at Yuetan subdistrict in Beijing in mainland China).

1. Questionnaires were used to collect the characteristic information of people living in Yuetan subdistrict in Beijing and select people who had been hospitalized because of any reasons between July 2012 and June 2014.
2. Data were collected on all patients admitted into different hospitals during the study period. The following information was recorded:demographic characteristics and admission category (whether medical, scheduled surgery, nonoperative trauma, or unscheduled surgery), presence of preexisting organ insufficiency,using definitions included in the Acute Physiology and Chronic Health Evaluation (APACHE) II score11; co- morbidities and the estimated prognosis of any preexisting underlying disease, following the classification of McCabe and Jackson.
3. Patients were included in the study cohort when having, in association with a documented or strongly suspected infection and fullfil the diagnostic criteria of sepsis according to the "Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock:2012".

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years;
* Having lived in Yuetan Subdistirct for at least 1 year
* Having, in association with a documented or strongly suspected infection and fullfil the diagnostic criteria of sepsis according to the "Surviving Sepsis Campaign:International guidelines for management of severe sepsis and septic shock:2012"

Exclusion Criteria:

* Age\<18 years
* Lived in Yuetan Subdistrict less than 1 year
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis

The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug.


Eligibility Criteria:
Inclusion Criteria:

* Have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an endoscopic subscore ≥2 within 14 days before the first dose of study treatment (note: a partial Mayo score of at least 4 and other eligibility criteria must have been met before endoscopy is performed as a study procedure)
* Have evidence of UC extending proximal to the rectum (≥15 centimeters \[cm\] of involved colon)
* Up-to-date colorectal cancer surveillance (performed according to local standard), for subjects with family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factor
* Participants must either: be naive to biologic therapy (eg, tumor necrosis factor \[TNF\] antagonists or vedolizumab) and have at least 1 of the following: inadequate response or failure to tolerate current treatment with oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) OR have received treatment with 1 or more biologic agents (eg, TNF antagonists or vedolizumab) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment

Exclusion Criteria:

* Have been diagnosed with indeterminate colitis, proctitis (distal disease involving the rectum only; less than 15 cm from the anal verge) or Crohn's Disease
* Have had surgery for treatment of UC or are likely to require surgery for UC during the study
* Have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 30 days of screening
Acoustic Radiation Force Impulse Imaging (ARFI) in Patients After Liver Transplantation

Aims: Prospective evaluation of the applicability of acoustic radiation force impulse(ARFI) imaging to assess liver fibrosis in patients after orthotopic liver transplantation.

Material and methods: We prospectively assess the performance of ARFI imaging in planned 100 patients after orthotopic liver transplantation. We evaluate shear wave velocity of the left and right liver lobe with the convex array (6C1HD)ultrasound transducer and compare the results with clinical data and B-mode criteria.

ARFI elastometry is an increasingly popular non-invasive method for the assessment of hepatic fibrosis and cirrhosis. To date, ARFI technology has not been applied systematically in patients after orthotopic liver transplantation. Therefore we want to establish standard values in this population.


Eligibility Criteria:
Inclusion Criteria:

* Patients after orthotopic liver transplantation.

Exclusion Criteria:

* Patients without status after orthotopic liver transplantation.
Epidemiological Study of Out-of-hospital Cardiac Arrest in Shenzhen

The epidemiology of out-of-hospital cardiac arrest (OHCA) is a significant public health issue, and large-sample studies on such events within China are relatively limited. This study utilizes the Utstein model to evaluate and analyze the epidemiological characteristics of OHCA in Shenzhen from 2011 to 2018. By reviewing ambulance dispatch records and prehospital medical records from the Shenzhen Emergency Medical Center between 2011 and 2018, the study analyzed epidemiological characteristics and reported the results. The main indicators of the study include demographic characteristics such as the gender, age, location of occurrence, key time points, vital signs, chief complaints, and diagnoses of the cases. It also covers prehospital emergency treatment processes, including whether bystanders performed CPR, initial electrocardiogram results, intravenous access establishment, use of epinephrine, defibrillation, tracheal intubation, and other interventions, as well as the outcomes of resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* Cases with secondary diagnoses containing only the diagnostic keywords "cardiac arrest" and "sudden death"

Exclusion Criteria:

* 1. Cases with suicide, drowning, advanced cancer, trauma, shock, poisoning, cerebrovascular accidents, etc. 2.Cases with duplicate records for gender, age, time of call, pick-up and drop-off address, and initial diagnosis.
Use of Perfusion Index Change as a Predictor of Hypotension During Propofol Sedation in Adult Patients Undergoing Hip Surgery Under Spinal Anesthesia: A Prospective Observational Study

This observational study is to evaluate Perfusion Index Change as a Predictor of Hypotension During Propofol Sedation in Adult Patients Undergoing Hip Surgery Under Spinal Anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients having hip surgery under spinal anesthesia and propofol sedation

Exclusion Criteria:

* ASA class IV or above
* pregnancy
* inability to measure noninvasive blood pressure on the arm
* preexisting hemodynamic instability
* known peripheral artery occlusive disease
* known autonomic nerve dysfunction
* uncontrolled hypertension
Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer

In 2009, Prof. Hohenberger proposed complete mesocolic excision (CME) as standardized, in which the same principle of TME in rectal cancer has been applied to the colon. More and more surgeons pay attention to the rationality of this surgical approach. However, the clinical application researches are still few, in particular the prospective controlled study is still none. This clinical trial will compare the CME group and non-CME group to evaluate the outcome and safety of CME for apply in clinic.

Materials and Methods:

All the patients with colon cancer will undergo elective radical operation. The observations were recorded during the operation and on the postoperative specimens. Intra-operative photographs were taken at various stages, as were photographs of the postoperative specimen. According to the CME operation keypoints, all the photographs will accept third-party assessment of the expert group, while the third-party expert group will not participate in the management of patients. Both of The evaluators and research doctors are double-blind state. The postoperative patients will divided into two groups according to the results of the assessment. The clinical and pathological data of the patients as well as follow-up information will be recorded and collected.

1. Outcome of CME By comparison to clinicopathologic variables, and precise tissues morphometry of two groups, the prognosis, lymph nodes harvest and removal of the mesocolic area were investigated. Outcomes of interest also include disease-free survival, local recurrence-free survival, recurrence rate. In addition, we analyzed the correlation between mesocolic area and height, weight, body surface area and body mass index.
2. Safety of CME CME group and non-CME group were compared the differences of security, included operation time, blood loss, postoperation complications, flatus restoring time, defecation restoring time, drainage removal time, Diet restoring time, drainage volume in three days after surgery, hospital deaths, the exhaust time, hospitalization time and hospitalization costs. In addition, the feasibility of CME techniques as the surgical approach of choice for elderly patients was also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of colon cancer;
* Clinical stage Ⅰ \~ Ⅲ;
* Undergoing colorectal surgery for the first time;
* Accept laparotomy;
* Accept radical resection;
* More than 18 years.

Exclusion Criteria:

* Emergency surgery;
* Preoperative neoadjuvant chemoradiotherapy history;
* Combined with other malignant diseases;
* Pathological stage Ⅳ patients with colon cancer.
Open-Label Expanded Access for Ebola-Infected Patients to Receive Human MAb Ansuvimab As Therapeutic or for HR PEP

The human monoclonal antibody (mAb), ansuvimab (mAb114), will be provided to Ebola-infected patients as either a treatment or as PEP under an expanded access protocol. Ansuvimab is administered at 50 mg/kg as a single intravenous (IV) infusion

This is an open-label, intermediate-size patient population, expanded access protocol (EAP) of ansuvimab administered once by IV infusion at a dose of about 50 mg/kg (weight-based dosing). Participants will be monitored and assessed daily for safety, including clinical observation, laboratory monitoring, the incidence of adverse events (AEs) and serious adverse events (SAEs) as defined by protocol, including AEs that by clinical judgement are atypical for orthoebolavirus zairense (EBOV) in infected patients, and any AEs that occur during product infusions. PEP participants will be followed to determine outcome following ansuvimab administrations through the study period for EBOV status (positive/negative). Blood will be collected for protocol-specific assessments and RT-PCR evaluation of viral load by available assay. A blood sample for Ebolavirus viral load measurement will be collected before mAb114 administration and at subsequent study time points per the Schedule of Evaluations. Participants will be followed for a period as defined by protocol after the product administration. Survival status for infected patients and follow up for PEP participants for signs/symptoms of EBOV will be recorded as applicable.

Ansuvimab will be provided for expanded access in any EBOV outbreak location as authorized by the applicable Regulatory Authorities and/or Ethics Committee(s).

Eligibility Criteria:
Inclusion Criteria:

* Male or female with laboratory confirmed (based on local standard of care) EBOV infection or with recent high-risk EBOV exposure as determined by a treating Physician or designee.
* Able to provide proof of identity to the satisfaction of the clinical team
* Able and willing to complete the informed consent process personally, or if the patient is unable to do so, then informed consent completed by a legally-authorized representative according to local laws and regulations.

Exclusion Criteria:

- Any medical condition that, in the opinion of the Treating Physician, would place the patient at an unreasonably increased risk through participation in this treatment protocol.
The Effect of Message Framing on Blood Donation-Study 2

Rh negative blood group is a rare blood group in China, as it only accounts for 0.3-0.4 percent of the Han population. Therefore, low inventory is often found in blood collection and supply agencies in many regions in China. In order to assess the effects of the gain-versus-loss framing message on blood donation among Rh negative donors, we designed two kinds of self-administered, standardized and structured questionnaires. In addition of the basic socio-demographic characteristics, one questionnaire includes the questions which survey the attitude of saving patients lives, and the other was to survey the attitude of preventing patients from death. The questionnaires were randomly sent to Rh negative blood donors.


Eligibility Criteria:
Inclusion Criteria:

* Rh negative blood donors who have donated blood between 2016 and 2018.

Exclusion Criteria:

* People who are Rh negative blood type but never have donated blood.