cyrilzakka/clinical-trials huggingface dataset:
Predicting Morbidity and Mortality in Elderly Surgical Patients

This proposed multicentre study builds on the findings of our recent validation of USEM and mCriSTAl predictive tools in a single centre at the Complejo Hospitalario de Navarra, whose results were recently published (https://europepmc.org/article/med/33111261). By expanding to a multicentre cohort and comparing to a third instrument, the investigators aim to examine the independent validity and generalizability of three scores and investigate potential for simplification of the prediction with anticipated greater accuracy. The ultimate goal is to determine whether these predictive tool can be used to assist surgical decision-making about older patients with expected poorer prognosis or high risk of death in the short term.

Eligible institutions: large hospitals (\>200 beds) with wards admitting older surgical patients where (a) electronic medical records are available, (b) have staff committed to recruiting a minimum of 100 participants with complete follow-up, and (c) give consent for the Lead statistician in Spain to access de-identified data for aggregated analysis.

Procedures: Recruitment is anticipated to take 6-12 months and will be conducted prospectively after screening by non-specialist hospital staff (junior doctors, medical students, nurses) confirms eligibility. The 3-month follow-up for outcomes will include completion of a standard questionnaire/form via either review of clinical record, access to death records (where applicable), or telephone call to families/proxy/next of kin/person responsible at 3 months after initial recruitment.

Findings will be published in aggregated and anonymized form, but if the sample from individual participating institutions is large enough, hospital-specific profiles can be delivered in identifiable form to relevant hospitals for the benefit of clinicians and service administrators.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥65 years.
* Present in the ED with acute abdominal pathology that requires urgent abdominal surgery

Exclusion Criteria:

* Patients who receive non-operative management
* Informed consent form not signed by patient or their proxy
Clinical Reminders in Test Reports to Improve Guideline Compliance

This study examines the impact of adding a statement to the echocardiography report that advises anyone reading the report regarding if and when a follow-up study is recommended.


Eligibility Criteria:
Inclusion Criteria:

All patients undergoing echocardiography where the physician creating the report feels a comment is appropriate regarding when follow-up should or should not occur.

Exclusion Criteria:

None.
Alveolar Ridge Preservation Using a Composite Graft Plug: Radiographic and Clinical Assessment

The goal of this clinical trial is to determine whether a graft material introduced recently (test) to be used in extraction sockets is as good as a previously known graft material (control) in adults undergoing tooth extraction of a single-rooted tooth.

The main question it aims to answer is:

Is this graft material able to maintain good bone volume and composition after extraction?

Researchers will compare this new graft to a well-studied graft material.

Participants will be randomly assigned to one of the groups and will receive the allocated graft after tooth extraction. The dimension of the alveolar ridge, which supports teeth in the jaw, will be measured before extraction and four months after healing. A cone beam CT Scan will also be obtained.

Alveolar ridge resorption after tooth extraction poses a substantial obstacle for subsequent implant placement, frequently necessitating ridge augmentation treatments. Alveolar ridge preservation (ARP) is intended to reduce these dimensional alterations. Various grafting materials have been used for ARP, with varying success rates in maintaining ridge dimensions. This study compares the clinical and radiological outcomes of a composite graft plug of bioactive resorbable calcium apatite crystals embedded in a collagen matrix to a typical allograft.

This randomized controlled clinical experiment comprised 26 people needing a single-rooted tooth extracted. They were divided into two groups: composite plug and allograft. Clinical measures of soft tissue were collected at baseline and four months after extraction using a stent with reference points. At baseline and four months after extraction, radiographic examinations were performed using cone beam computed tomography (CBCT).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* planned for extraction and alveolar ridge preservation of a single-rooted tooth - -- healthy or have well-controlled systemic disease
* good oral hygiene
* healthy periodontium or at least at the extraction area.

Exclusion Criteria:

* smoking ≥10 cigarettes per day
* generalized periodontitis
* poor oral hygiene
* uncontrolled systemic diseases such as diabetes
* pregnancy
* history of anti-resorptive therapy such as bisphosphonate
Thirty Million Words Project: A Feasibility Trial

The purpose of the proposed research is to evaluate the Thirty Million Words (TMW) Intervention through a randomized, controlled pilot study. The primary goal of the intervention is to enrich the early language learning environment of children from low-socioeconomic status (SES) backgrounds by targeting parent skills that relate to adult word input and conversational turn taking. The investigators hypothesize that receiving the TMW intervention will result in changes in parent behaviors.

The investigators propose to administer the TMW intervention to a small group of parents from low SES backgrounds in the Chicago area, assessing outcomes for caregivers at specific time intervals after administration. An audio environment recording device, the Language ENvironment Analysis recorder (LENA), will be used to gather information about the child's home language environment. The treatment group will receive feedback from some of these home audio recordings to motivate behavior change. A comparison between measurements from baseline recordings (without linguistic feedback given) and recordings during the intervention program (with linguistic feedback given) will be used to evaluate changes in caregiver linguistic behavior. In addition to the report information, parents will also be provided with strategies for enriching the child's language environment, including advice on book reading and narration. A control arm will receive a brief nutrition intervention and complete the same number of recordings as the treatment group. The control group will complete the same assessment schedule as the treatment group. Assessment data will aid in evaluating the effects of the TMW intervention.

This pilot work is a critical step in understanding the language environment provided by parents of low-SES, the effectiveness of objective feedback, and the potential for change and improvement in parental behavior. After establishing a baseline of parent-child communication levels, LENA recordings will be performed at regular intervals to provide essential feedback and motivation for parents to continually optimize the language environment they provide for their children.

Eligibility Criteria:
Inclusion Criteria:

* Low-SES: income proxies and education proxies

Exclusion Criteria:

* High-SES: income proxies and education proxies
* developmental delays
* medical conditions that affect child speech or hearing
Effect of Agonist Contract Relax Versus Antagonist Contract Relax in Chronic Stroke Patient.

It will be a randomized control trial with 112 patients which will be divided into two groups of 56 patients in each group. Participants will recruit through convenient sampling techniques.

Outcome measures are range of motion and spasticity. The protocol was implemented three days per week for eight consecutive weeks. Data will be collected at baseline and 8 th week after intervention.

Objective of the study is to compare the effects of the agonist contract-relax technique versus the antagonist contract-relax technique on spasticity and range of motion in individuals with chronic stroke.

Null hypothesis (H0):

There are no comparative effects of agonist contact-relax technique and the antagonist contract-relax technique on spasticity and ankle range of motion in chronic patients.

The alternate hypothesis (HA):

There are comparative effects of agonist contract-relax technique and the antagonist contract-relax technique on spasticity and ankle range of motion in chronic stroke patients.

The sample size came out to 94 (47 in each group) after adding 20% dropout the sample size was 47+9=56 in each group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of stroke by a neurologist.
* Inclusion of patients with both ischemic and hemorrhagic stroke.
* Both male and female patients are eligible.
* Age range between 40 to 60 years.
* Modified Ashworth Scale ranging from 0 to 2.
* Minimum muscle strength grade of 3

Exclusion Criteria:

* History of surgery on lower limb
* Who received injection therapies for reducing spasticity
* Lower extremity contracture
* Modified Ashworth scale of 3-4
Cognitive Behavioral Treatments for Depression in Chronic Illness

Duke University Medical Center in collaboration with Glendale Adventist Medical Center propose a randomized clinical trial of conventional cognitive behavior therapy (CCBT) vs. religious cognitive behavior therapy (RCBT) for major depression in medical patients with chronic disabling illness. Therapists will deliver the treatment in real time over the Internet and/or by telephone to increase treatment access. This planning grant seeks support for a two-site study (North Carolina and California) that consists of two phases. In Phase I (Rounsaville 1a) the investigators will conduct an open trial of 30 patients to assess subject recruitment, refine RCBT and CCBT manuals and protocol, assess compliance with treatment, acceptability of treatment and delivery system (online vs. telephone), and allow therapists gain experience with delivery system and RCBT.

In Phase II (Rounsaville 1b) the investigators will conduct a randomized proof of concept comparison of CCBT vs. RCBT that will demonstrate feasibility and confirm the expected clinically meaningful difference for a definitive R01 application. In Phase II, 70 religious patients ages 18-85 with a new episode of major depression (MINI), scores of 16-35 on the Beck Depression Inventory (BDI), and at least one chronic disabling medical illness will be randomized to either CCBT or RCBT. The trial will consist of ten 50 min sessions administered by master's level therapists and delivered over 12 weeks. The primary endpoint will be BDI score at baseline, 4, 8, 12, and 24-week follow-up. Christian, Jewish, Hindu, Buddhist, and Muslim versions of the RCBT manual will be developed, and CBT experts in each of these traditions will supervise therapists delivering the intervention to patients from these faith traditions.

The purpose of this study is to determine feasibility and effect sizes for a future, fully powered treatment study. The importance is that results will be relevant to therapists well beyond those who explicitly practice pastoral counseling, extending to many secular therapists as well. If 65% of Americans indicate that religion is an important part of daily life and the vast majority of chronically ill medical patients wish to include it in their therapy, then all therapists (whether they have explicit training in pastoral counseling or not) are likely to encounter patients in which this approach would be applicable.


Eligibility Criteria:
Inclusion Criteria:

* chronic disabling medical illness
* religion at least somewhat important to patient
* major depressive disorder by MINI neuropsychiatric interview
* Beck Depression Inventory scores of 16-28 (moderately severe depression)
* live near Durham, North Carolina, or near Glendale, in Southern California

Exclusion Criteria:

* significant cognitive impairment
* significant suicidal thoughts or risk
* no access to telephone
Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously Vaccinated

The purpose of this study is to evaluate the levels of antibodies 1 year after receiving the second vaccine dose in two groups of adults over the age of 60: (1) those who have previously received 2 doses of 13-valent pneumococcal conjugate vaccine (13vPnC) and (2) those who have previously received 1 dose of 13vPnc and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). This study will also assess whether the use of the 2 vaccines, 13vPnC and 23vPS, administered in different sequential order results in different prolonged antibody levels. This study is limited to individuals who participated in either study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572).


Eligibility Criteria:
Inclusion Criteria:

* Only study volunteers who received both assigned vaccinations at visit 1 and visit 4 when they participated in either study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572)

Exclusion Criteria:

* Vaccination with any licensed or experimental pneumococcal vaccine since being enrolled in the 6115A1-3005 (NCT00546572) or 6115A1-3010 (NCT00574548) study (other than study vaccines permitted in 6115A1-3010 or 6115A1-3005)
Understanding Your Baby: A Parallel Group Study of a Universal Parenting Support Program

In Understanding Your Baby first-time parents receive research-based knowledge on how to interpret their infants' socioemotional needs based on their behavior, and how to meet their infants' socioemotional needs in accordance with their developmental stage. This information is delivered to parents at routine home visits by public health nurses, who are trained in the research base behind the program, and using cue cards and short video clips, which concretely exemplify how infants signal their socioemotional needs and inspire to positive activities between parents and their infants.

The aim of Understanding Your Baby is to support infant socioemotional development by increasing parents' abilities at perceiving, understanding, and responding to their infant's socioemotional signals. Evaluation is based on a parallel group study, with half of the participants receiving care as usual and half of the participants receiving care as usual and Understanding Your Baby. The primary outcome is parental sense of competence and secondary outcomes are parental stress and child socioemotional development.


Eligibility Criteria:
Inclusion Criteria:

* First-time mother or father/partner
* Singleton pregnancy
* Mother living together with the baby
* Mother living in the Danish municipalities of Køge, Hvidovre, Høje-Taastrup, Frederiksberg, Lolland, Holbæk, Næstved, Middelfart, Nyborg or Aalborg.
* Understands Danish or English

Exclusion Criteria:

* Under the age of 18 when the child is born
Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma

Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Over 19 years
* Diagnosis of HCC
* Unresectable asymtomatic uninodular or multinodular tumor.
* Subject who maintain clinically normal hepatopetal flow without main portal vein closure
* At least one measurable target lesion by CT or MRI which 10 mm or more and 100 mm or less.
* ECOG Performance Status of 0 or 1.
* Child-Pugh class A or B
* Life expectancy of at least 6 months.

Exclusion Criteria:

* Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
* Hepatic resection, liver transplantation or Percutaneous local treatment
* Previously received HCC related medical procedure
* Previously treated with anthracyclines
* Only measurable disease is within an area of the liver previously subjected to radiotherapy.
* Child Pugh C
* Active gastrointestinal bleeding within 6 months from screening.
* Total bilirubin \> 3mg/dL
* WBC \< 3,000cells/mm3
* Platelet \< 50,000mm3
* Serum creatinine \> 2mg/dL
* INR\> 1.4
* ALT and AST \> 5 times UNL
* Diffuse HCC defined as \>50% tumour involvement of the whole liver.
Continuous Versus Intermittent cARdiac Electrical moNitorinG

The purpose of this study is to validate the continuous patch monitoring system to evaluate cardiac arrhythmias in patients receiving drugs that can cause cardiac complications and compare the continuous patch system with standard electrocardiograms (ECGs).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute promyelocytic leukemia (APL) and being initiated on standard of care arsenic trioxide OR Diagnosis of solid tumor and being initiated on standard of care capecitabine (alone or as part of combination treatment) OR Diagnosis of solid tumor and being initiated on standard of care ribociclib (alone or as part of combination treatment)
* At least 18 years of age.
* No allergy to adhesive patches.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Younger than 18 years of age
* Allergy to adhesive patches
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma

Phase I, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent CBL0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma who are candidates for immune checkpoint blockade and have tumors accessible for serial biopsies.

The primary objectives will be Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have:

   1. Pathologically proven stage III melanoma with one or more macroscopic lymph node metastases (measurable according to RECIST v. 1.1) amenable to biopsy and/or surgery OR:
   2. Patients considered to have stage III or stage IV disease amenable to serial biopsies as determined by the treating physician. Note: patients with in-transit metastasis may be eligible after surgical consultation if not surgical candidates.
   3. Patients must have disease amenable to and must be willing to undergo protocol-directed repeat biopsies and blood draws.
2. Age \> 18 years
3. ECOG performance status 0 or 1
4. Patients must have normal organ and marrow function

Exclusion Criteria:

1. Patients may not be receiving any other investigational agents
2. Patients with a known active autoimmune disease
3. Prior treatment with CTLA-4 or PD1/PD-L1 pathway targeted systemic treatment
4. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids
5. Patients with ongoing diarrhea (\> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy
HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients

This study will be conducted as a single-center, prospective, open-label, randomized trial that will evaluate adult patients admitted with septic shock to the medical critical care unit (MCC). The objective of the study is to determine if the use of hydrocortisone plus fludrocortisone is associated with a faster resolution of shock (defined as 24 hours vasopressor free) when compared to the use of hydrocortisone alone in medical, critically ill septic shock patients.

For three consecutive months, side 1 of the medical critical care unit (MCC1) will receive hydrocortisone alone and side 2 (MCC2) will receive the combination of hydrocortisone and fludrocortisone. After the initial three months, this will be flipped and patients admitted to MCC1 will receive the combination while patients in MCC2 will receive hydrocortisone alone for three consecutive months. This change in group assignments will occur to account for the difference in number of beds between MCC1 and MCC2, and to minimize the potential differences in patient acuity by location.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill medical patients requiring addition of stress dose steroid therapy (hydrocortisone) in addition to pressors for septic shock management during ICU stay
* Fludrocortisone administered within 24 hours after initiation of hydrocortisone if in combination therapy group

Exclusion Criteria:

* Use of fludrocortisone and/or hydrocortisone for any reason other than septic shock management during ICU stay
* Fludrocortisone/hydrocortisone initiated by any service other than critical care medicine
* Prior use of fludrocortisone/hydrocortisone at time of admission (home or outside facility)
* Patients not appropriate for study inclusion as determined by provider discretion
* Patients receiving steroid therapy not in accordance with assigned group per location (MCC1 or MCC2)
* Patients re-admitted to the MCC during the same admission and restarted on vasopressor therapy will be noted during data collection and only the initial admission will be included for analysis
* Any patient receiving greater than one dose of hydrocortisone 100 mg
* Physical or medical contraindication to receiving PO or PER FT (per feeding tube) fludrocortisone
Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis

The purpose of this study is to determine if the combination of ursodeoxycholic acid (UDCA) and fenofibrate is more effective than UDCA alone in the treatment of primary biliary cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21 and ≤ 75 years old
2. Established diagnosis of PBC and positive AMA
3. Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year
4. Incomplete response to UDCA defined as serum ALP ≥ 2 times the upper limit of normal on two separate measurements despite at least 1 year of therapy with UDCA
5. Female patients of childbearing age need a negative pregnancy test performed within 7 days of enrollment, and need to be on adequate contraception throughout the study period
6. Signed informed consent after careful review of information and study details

Exclusion Criteria:

1. Hypersensitivity to fenofibrate
2. Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids.
3. Prisoners and institutionalized subjects, pregnant or nursing women
4. Anticipated need for liver transplantation within one year (estimated 1-year survival \<80% as predicted by the Mayo risk score).
5. Recipients of liver transplantation
6. Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
7. Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis
8. Acute or chronic renal failure, defined as GFR \< 60 ml/min
9. Known history of cholecystitis with intact gallbladder
10. History of, or known high risk for, venous thromboembolism
11. Current use of warfarin or statins