cyrilzakka/clinical-trials huggingface dataset:
How Much Cardiac Output is Enough?

Low output syndrome is a common complication in patients undergoing cardiac surgery. Its incidence was reported to be 2 to 6% \[1\]. Morbidity and mortality of low output syndrome is high and the costs for treating the disease are immense.

The primary objective of this prospective observational study is to define a threshold for a critically reduced cardiac output requiring immediate therapy.

Low output syndrome is a common complication in patients undergoing cardiac surgery. Its incidence was reported to be 2 to 6% \[1\]. In patients suffering from low output syndrome cardiac output is severely reduced due to myocardial failure. Among other reasons for myocardial failure, ischemia, insufficient myocardial protection during aortic cross-clamping, and severely reduced ventricular function prior surgery are the most common risk factors for low output syndrome. Low output syndrome is treated with positive inotropic drugs and mechanical assist devices \[2\]. Morbidity and mortality of low output syndrome is high and the costs for treating the disease are immense.

If cardiac output cannot be increased cardiac failure persist and vital organs are hypoperfused. Critical and prolonged hypoperfusion results in single and multi organ failure. Until today a definite threshold for a critically reduced cardiac output or cardiac index requiring immediate therapy is not completely known. Cardiogenic shock is diagnosed by clinical signs and it is not diagnosed by cardiac output or cardiac index. The critical value for a severely reduces cardiac index was reported to be in a range of 1.75 to 2.5L/min/m² \[3-5\].

The primary objective of this prospective observational study in 600 patients undergoing cardiac surgery is to try to define a threshold for a critically reduced cardiac output or cardiac index requiring immediate therapy.

If cardiac output and cardiac index are not reduced below a critical threshold, morbidity, mortality, and length of stay in the intensive care unit and in the hospital are reduced \[6\].

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery,
* Written informed consent

Exclusion Criteria:

* Missing consent
Safety and Effectiveness of Drop-free Small Incision Cataract Surgery

This is a randomized control trial comparing the effects of subconjunctival triamcinolone administration during surgery to topical prednisolone drops on the development of post-operative inflammation and macular edema in manual small incision cataract surgery.

Eye drops given following cataract surgery for prevention of post-operative inflammation carry many disadvantages, such as cost and poor medication adherence. To eliminate these barriers, the emerging technique of single dose of subconjunctival triamcinolone delivered during surgery has been shown an effective and safe alternative. The goal of this study is to build on this evidence, utilizing subconjunctival triamcinolone in conjunction with a different surgical technique and population as what was previously studied. This is a randomized control trial comparing the effects of single-dose subconjunctival triamcinolone administration at the time of surgery to the standard 4-week taper of topical prednisolone drops following manual small incision cataract surgery in Guatemala. Patients will be evaluated at post-operative weeks 6 and 12 with the primary outcome variables of intraocular pressure and best corrected visual acuity. Data on presence and amount of corneal edema, anterior chamber inflammation, and development of macular edema will also be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Presence of a visually significant cataract: nuclear sclerotic, posterior subcapsular and/or cortical
* Best corrected visual acuity or 20/40 or worse

Exclusion Criteria:

* Axial length \< 20 or \> 26 mm
* Cataract which is traumatic, subluxated, or Morgagnian
* Presence of ocular comorbidity: including corneal or retinal abnormalities (corneal opacities, macular degeneration, macular scars, epiretinal membrane, retinal detachment, retinal vascular occlusion), glaucoma, ocular hypertension, glaucoma suspect (cup-to-disc ratio of 0.7 or more, history of steroid response, history of uveitis, pseudoexfoliation
* History of endophthalmitis or macular edema in the fellow eye
* Personal history of diabetes mellitus or uncontrolled hypertension
* Currently pregnant or lactating women
* Current use of systemic steroids for asthma, rheumatoid arthritis or other illness or history of steroid use by any route in the prior 3 months.
* Intraoperative complications including posterior capsular rupture, iris prolapse, zonular dialysis, retained nucleus, vitreous loss, iris trauma resulting in hemorrhage, Descemet dehiscence of more than 1 mm x 1 mm
Performance Nutrition for Residents and Fellows

Currently, residents commonly experience dehydration and poor nutrition during nighttime duty hours as a result of heavy work load, lack of time to take nutrition and hydration breaks, or limited or no access to healthy food and drinks which may affect residents' work performance. The goal of this study is to compare the effects of two different meal compositions with no typical dietary practices (existing conditions) on work performance of the on-call residents during night shifts.

The purpose of this study is to determine the effects of dietary modifications on resident physicians' work performance during night shifts.

Specific objectives are:

1. To assess the effects of macronutrient composition of the test meals on cognitive performance, self-reported sleepiness and fatigue of resident physicians during night-time duty.
2. To compare to no intervention, the effects of providing meals before 22:00 hours, and only providing chewing gum, tea, coffee and water onwards to on-call residents, on cognitive performance, self-reported sleepiness and fatigue of resident physicians during night-time duty.

Eligibility Criteria:
Inclusion Criteria:

* All residents and fellows performing in hospital overnight work
* Must be able to eat plant source foods (e.g. soy, nuts, seeds) and animal source foods (e.g. meat, eggs, dairy products)

Exclusion Criteria:

* Food allergies or sensitivities
* Prior anaphylactic reaction to food
* Strict dietary restrictions (e.g. vegan, gluten free)
Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving isotretinoin and interferon alpha-2b together with paclitaxel may reduce drug resistance and allow the tumor cells to be killed.

PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alpha-2b together with paclitaxel works in treating patients with stage IV, recurrent, or persistent cervical cancer.

OBJECTIVES:

* Determine the response in patients with stage IVB, recurrent, or persistent cervical cancer treated with isotretinoin, interferon alpha-2b, and paclitaxel.

OUTLINE: This is a multicenter study.

Patients receive oral isotretinoin and interferon alpha-2b subcutaneously once daily on days 1-4 and paclitaxel IV over 3 hours on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 27-66 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically and/or cytologically confirmed cervical cancer, meeting 1 of the following criteria:

  * Stage IVB disease
  * Recurrent disease
  * Persistent disease
* Patients previously treated with chemoradiotherapy as initial therapy must demonstrate disease progression
* Measurable disease by physical exam or radiographic studies
* Not amenable to chemoradiotherapy or surgery

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* ECOG 0-2

Life expectancy

* At least 6 months

Hematopoietic

* WBC ≥ 3,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* SGOT and SGPT ≤ 2 times upper limit of normal
* Bilirubin ≤ 1.5 mg/dL

Renal

* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 50 mL/min

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known HIV positivity
* No active infection
* No medical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior interferon
* No other concurrent immunotherapy

Chemotherapy

* See Disease Characteristics
* At least 3 months since prior chemoradiotherapy (6 weeks for patients experiencing disease progression after completion of initial chemoradiotherapy)
* No other prior chemotherapy

Endocrine therapy

* No concurrent hormonal therapy for cancer

Radiotherapy

* See Disease Characteristics
* See Chemotherapy
* Recovered from prior radiotherapy
* No concurrent radiotherapy

Surgery

* Recovered from prior surgery
* No concurrent surgery for cancer

Other

* No prior retinoids
* No other concurrent anticancer therapy
* No other concurrent experimental agents
Phase 1b Study of CCX872-B in Patients With Pancreatic Adenocarcinoma

This is an open-label phase 1-b study to evaluate the safety and efficacy of CCX872-B in patients with pancreatic adenocarcinoma also receiving FOLFIRINOX chemotherapy.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non-resectable pancreatic adenocarcinoma with or without metastases
* Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
* Anticipated life expectancy ≥ 12 weeks
* Radiographically measurable disease acc. to RECIST 1.1
* Use of adequate contraception (as described in protocol)
* Ability to provide written informed consent and comply with study requirements

Exclusion Criteria:

* Received other cancer treatment or investigational drug within 4 weeks prior to screening
* Women who are pregnant or breastfeeding
* Had major surgery within 4 weeks of first dose of study drug
* Inadequate liver, renal or bone marrow function within 2 weeks of first dose
* Serious concurrent illness, altered medical status or any uncontrolled medical condition
* Any infection requiring antibiotic or anti-viral treatment within 4 weeks of screening
* Known active HIV, HBV or HCV infection
* Inability to swallow tablets
* History or presence of any medical condition or disease which, in the opinion of the investigator, may place the subject at unacceptable risk for study participation
Fixation of the Posterior Malleolus in Medium-sized Trimalleolar AO Weber-B Fractures.

The optimal treatment of ankle fractures with involvement of the posterior malleolus remains a subject of debate. Despite a large amount of literature on the role of the posterior malleolus in a so-called trimalleolar fracture, there are no clear guidelines for its treatment. Its size is the leading indication whether fixation of the fragment is necessary or not. Most orthopedic surgeons consider a posterior malleolar fracture fragment larger than 25% to 33% an indication for fixation. Interestingly, after careful evaluation of the available literature, there does not seem to be hard evidence for these numbers. It is generally accepted that restoration of a normal anatomic mortise and normal tibiotalar contact area are key elements for a good functional outcome. Inadequate reduction of the posterior fragment may alter the tibiotalar contact area and the joint biomechanics with altered stresses in parts of the joint, leading to the development of osteoarthritis and worse functional outcome. Traditionally, reduction of these larger fragments is indirectly, followed by percutaneous screw fixation in anterior-posterior direction. Disadvantages are that it is hard to achieve an anatomical reduction, and that fixation of smaller fragments is very difficult. Recently, a direct exposure of the posterior tibia via a posterolateral approach in prone position, followed by open reduction and fixation with screws in posterior-anterior direction or antiglide plate is advocated by several authors. This approach allows perfect visualization of the fracture, articular anatomical reduction, and strong fixation. Another advantage is that even small posterior fragments can be addressed. Several case series are published, which describe minimal major wound complications, good functional outcomes, and minimal need for reoperation. Since 2 years, in our institution we perform an open, anatomical reduction and fixation of all medium-sized posterior fragments via this approach. Although not thoroughly investigated yet, it seems to lead to better clinical outcomes than described in the literature and our retrospective cohort study.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years old
* First ankle fracture of the affected side.
* Trimalleolar AO-Weber B fracture with additional medium-sized posterior fragment (5-25% of involved articular surface, AO type 44-B3)

Exclusion Criteria:

* severe traumatized patients
* Multiple fractures during visit emergency department
* Ankle fracture of the same ankle in the history
* Patients with pre-existent mobility problems
* Pre-existent disability
* Patients living in another region and follow-up will take place in another hospital.
* Inability to speak the dutch language.
A Long-term Follow-up Study of Subjects Who Received CRISPR CAR T Cellular Therapies

This study will evaluate the long-term safety and efficacy of CRISPR CAR T cellular therapies

All subjects with hematological and solid malignancies who are enrolled in a parent study and were exposed to allogeneic CRISPR CAR T cellular therapy will be asked to participate in this long-term follow-up (LTFU) study. Subjects who have completed the parent study for the protocol-defined duration, or who have discontinued the parent study early, or who are in secondary follow-up (follow up of subjects with progressive disease or who receive a subsequent line of anticancer therapy) in the parent study may enroll in this LTFU study. This will allow for collection of long-term efficacy data (as applicable) and safety data up to 15 years post-treatment with CRISPR CAR T cellular therapies.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and comply with protocol-required study procedures and voluntarily sign and date a written informed consent document.
* Must have received CRISPR CAR T cellular therapy.

Exclusion Criteria:

* There are no specific exclusion criteria.
Self-Management for Persistent Subacromial Pain

Physiotherapy-led exercises is the first line treatment for patients with subacromial pain. However, current evidence report that most treatment programmes only show a short-term benefit. There seem to be a potential for enhancing the effectiveness of exercise interventions by improving adherence to self-managed exercises, but there is lack of knowledge about adherence to exercise programmes in shoulder pain. Before conducting a planned randomised controlled trial on the clinical effectiveness of an intervention focusing on adherence to a self-managed exercise strategy (the Ad-Shoulder intervention), it is necessary to run a feasibility study in order to establish whether such a resource-demanding trial is worthwhile. Feasibility studies are designed to answer the key question "Can it work?" The main objectives of the present study was to assess the feasibility in terms of recruitment capability, data collection procedures and acceptability of the Ad-Shoulder intervention in patients with subacromial pain receiving treatment in primary or secondary health care.


Eligibility Criteria:
Inclusion Criteria:

* Pain located to the upper arm
* Had previously received conservative treatment due to subacromial pain
* Still seek primary or secondary care during the past 6 months

Exclusion Criteria:

* Frozen shoulder diagnosis (\<50% external rotation compared to contralateral side)
* Patients who have received surgical treatment due to shoulder problems
* Pregnant patients
* Patients with insufficient Norwegian language skills
* Serious psychiatric disorder
Vitamin D Level and Risk of Infections in Cirrhotic Patients

It is widely known that vitamin D has an important role in calcium metabolism and bone mineralization. Its deficiency is related to rickets and osteomalacia in children and adults respectively. Vitamin D had a role in innate and acquired immunity. It increases innate defense and modulates lymphocytes activation, leading to a change toward a T2 helper response ).

The role of vitamin D deficiency on the risk of bacterial infection among patients in intensive care units has been reported. An observational studies in children reported an association between low 25-OH vitamin D level and infectious viral diseases .

The deranged metabolism of vitamin D in liver cirrhosis was first reported in the late '70s and was attributed mainly to impaired 25(OH)-vitamin D hydroxylation of the precursor vitamin D caused by impaired liver function. Low level of vitamin D was found independently to be associated with increased risk of bacterial infections in patients with liver cirrhosis.

The observed relationship between the lack of vitamin D and the increase risk of mortality in cirrhotic patients could be attributed to bacterial infections. Thus, the association of low vitamin D levels with liver insufficiency and infections supports the use of vitamin D as a prognostic marker in the population of cirrhosis.

Studies on the role of vitamin D as a risk factor for infections in patients with liver cirrhosis are not well studied in our locality(Upper Egypt).


Eligibility Criteria:
Inclusion Criteria:

* Admitted patients with liver cirrhosis irrespective of the underlying etiology during 6 months in Al Rajhi Liver Hospital, Assiut, Egypt who accept to participate in the study

Exclusion Criteria:

* Patients with cholestatic liver disease, patients receiving antibiotics to treat their infection prior hospital admission and patients refusing to participate in the study.
SPECIAL INVESTIGATION FOR ABRYSVO IN PREGNANT WOMEN AND INFANTS

This post-marketing study is a multicenter cohort study in pregnant women vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in pregnant women and their infants under actual clinical practice in Japan.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women who have been vaccinated with Abrysvo for the first time after Abrysvo is launched. Pregnant women who have previously participated in the clinical trials of Abrysvo will be excluded.
2. Vaccinated participants who have provided written consent regarding their participation in the study and entry of symptoms to ePRO with the use of their devices (smartphones, tablets PC, etc.) (or paper-PRO if there is any compelling reason) upon understanding the explanatory document. For a minor vaccinated participant, the parent(s) or legally acceptable representatives shall provide written consent.
3. Pregnant women who have provided written consent to the participation of their infants in the study. For a minor vaccinated participant, the parent(s) or legally acceptable representatives shall provide written consent.

Exclusion Criteria:

* There are no exclusion criteria for this study.
Cellular Immune Responses in the Liver in Chronic Hepatitis C (CHC) Patients

In order to persist in the liver, HCV has numerous nonspecific and specific strategies to overcome the immunity of the host. The crucial step in the establishment of viral persistence and chronic hepatitis is the avoidance of specific antiviral cellular immune response in the liver. Treatment with pegylated interferon alpha (IFNα) in combination with ribavirin (RBV) is the standard therapy for chronic hepatitis C is. The response to IFNα / RBV therapy depends on the effective cellular antiviral immune response in the liver. The understanding of the interaction between HCV and cellular immune response is important for the effective use of existing diagnostic techniques, the Individual control and adjustment of the current therapeutic approaches and the development of future therapeutic and immunization strategies. In this study, the investigators want to investigate cellular Immune responses in the liver of HCV infected patients and characterize the influence of these immune responses to the response to IFNα / RBV therapy.


Eligibility Criteria:
Inclusion Criteria:

* proven chronic hepatitis C
* aged between 18 and 65
* willingness to give written informed consent to the study protocol

Exclusion Criteria:

* history of having received any IFN, PEG-IFN or RBV
* not eligible for antiviral treatment with peginterferon and ribavirin by standard of care
Multi-center, Single Arm, Observational Study to Evaluate the Safety of Dapagliflozin in Type 2 Diabetes Mellitus Patients in China

DONATE study is a multi-center, prospective cohort, single arm, observational study to be performed in 3000 Chinese type 2 diabetes mellitus (T2DM) patients recruited from 100 tier 2 or 3 hospitals, China.It is a drug intense monitoring study required by China Food and Drug Administration (CFDA) to assess the newly approved drug in at least 3000 patients within the first five years after commercial launch. The primary objective is to demonstrate the safety of dapagliflozin by assessment of the incidence of adverse events and serious adverse events during 6-month follow up in Chinese patients with T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Provision of subject informed consent prior to any study specific procedures.
* Chinese, Female or male.
* T2DM diagnosed by physicians according to 2013 Chinese Guideline for Diabetes, ie. 1) Patients with typical syndrome and with a FPG ≥ 7.0mmol/L and/or random plasma glucose ≥ 11.1mmol/L; and/or, 2) patients without typical syndrome and with repeated FPG ≥ 7.0mmol/L and/or 2 hour post challenged plasma glucose ≥ 11.1mmol/L.
* Subjects who already took at least one dose of dapagliflozin, which is prescribed by physicians based on their clinical practice. The prescription of dapagliflozin is separated from the decision to be included in the current study or not.

Exclusion Criteria:

* Being unable to comply with study-specified procedures.
* Participating in any other clinical trial currently or during the last 3 months.
* Previous enrolment in the present study.