cyrilzakka/clinical-trials huggingface dataset:
Non-Cirrhotic Hyperammonemia Versus Hyperlactatemia in Septic Patients and Impact of Treatment

Objectives: This study aims to determine the validity of hyperammonemia in predicting true sepsis compared to hyperlactemia in critically ill septic patients.

Background: Sepsis is associated with amino acid flux towards the liver, which increases the ammonia load. The combination of decreased clearance and increased load is thought to be the major cause of increased ammonia in sepsis.

Methodology: 60 septic patients were classified into 2 equal groups, Group I: Septic patients with positive microbial cultures. Group II: septic patients with negative cultures enrolled to obtain serum ammonia and lactic acid levels on admission and every six hours for three days. The primary outcome was to detect ammonia specificity and sensitivity in predicting sepsis in comparison to lactate. The secondary outcomes were need for mechanical ventilation, mortality, and length of stay (LHS) within the intensive care unit.

Objectives: The study compares between non-cirrhotic hyperammonemia and hyperlactemia in predicting sepsis in critically ill septic patients.

The septic patients were classified into 2 equal groups, Group I: Septic patients with positive microbial cultures. Group II: septic patients with negative cultures enrolled to obtain serum ammonia and lactic acid levels on admission and every six hours for three days, to detect ammonia specificity and sensitivity in predicting sepsis in comparison to lactate. also, need for mechanical ventilation, mortality, and length of stay (LHS) within the intensive care unit were reported.

Eligibility Criteria:
Inclusion Criteria:

* adult patients aged 19-75 years old
* both sexes with severe sepsis and septic shock
* within the first 48 hours of ICU admission

Exclusion Criteria:

* Hepatic patients (cirrhotic, hepatitis),
* Renal failure, Ureterosigmoidostomy,
* Malignancy or on Chemotherapy,
* Pregnancy,
* Parenteral nutrition,
* Autoimmune diseases or Immunosuppressive illness, and
* Trauma
Interventional Cooperative Agreement Program - Vocational Intervention Demonstration

For many people with spinal cord injury or brain injury, seeking employment after injury is an important goal. There are services available to help people with disabilities. However, the best ways to coordinate and deliver these services are not yet known. This project will compare two ways of coordinating and delivering services that are designed to help people with spinal cord injury or brain injury obtain employment.

Employment is important for financial security, social connection, and life satisfaction. Unfortunately, rates of unemployment remain high among people with spinal cord injury (SCI) and brain injury (BI). To help address this challenge, the investigators are conducting a single-site, randomized, controlled trial to compare two programs intended to increase rates of employment among people with SCI or BI. In one program, services are coordinated by a counselor employed by the New Jersey State Division of Vocational Rehabilitation Services, a state-based agency that assists people with disabilities who are interested in pursuing employment. In the other program, services are coordinated by a facilitator who is employed by the rehabilitation hospital at which the participant receives inpatient care. Services provided in both programs will be customized to the participant's needs and goals. Services will begin in inpatient rehabilitation and may include education, therapy, equipment provision, counseling, and other interventions.

The project will enroll 500 participants who are interested in becoming employed or returning to work. Information about employment status, earnings, benefits use, community participation, and health will be collected through a combination of surveys, medical record review, and information available in state and federal administrative databases. Analyses will examine the rate of participants employed at 1 year after enrollment in each group, time to employment, earnings, benefits usage, community participation, and well-being. Findings from this study will be used to determine which ways of delivering services are most effective in enabling employment, and to provide information to help other rehabilitation centers adopt effective programs.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-62
* New Jersey resident
* Admitted to Kessler Institute for Rehabilitation (KIR) due to a spinal cord injury (SCI) or brain injury (BI)
* Receiving inpatient rehabilitation at KIR
* Community living in the state of New Jersey after discharge from KIR
CAE for Poorly Adherent Individuals with Schizophrenia

This project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered CAE among patients with schizophrenia (CAE-S).

Patients with schizophrenia will be randomly assigned to receive either CAE-S or eTAU following the baseline assessment. The primary feasibility outcomes will be attendance and patient satisfaction (Aim 1) and change from baseline to 12 weeks in schizophrenia symptoms as measured by the Positive and Negative Symptom Scale (PANSS) (Aim 2). An exploratory evaluation (Aim 3) will examine the posited mechanistic underpinnings of the CAE-S intervention by assessing change from screening to 12 weeks in psychotropic medication adherence as measured by the Tablets Routine Questionnaire (TRQ) and validated by eCAP (objective bottle openings). Secondary measures will include the Clinical Global Impression (CGI), functional status, quality of life and attitudes towards medication.

Eligibility Criteria:
Inclusion Criteria:

* Individuals age 18 and older with schizophrenia as confirmed by the Mini International Psychiatric Inventory (MINI)
* Prescribed an antipsychotic medication for treatment of schizophrenia
* Known to have medication treatment adherence problems as identified by the Tablets Routine Questionnaire (TRQ, 20% or more missed medications in past week or past month)
* Ability to be rated on psychiatric rating scales
* Currently in treatment or scheduled to receive treatment at a Community Mental Health Clinic (CMHC) or other clinical setting able to provide mental health care during and after study participation
* Able to provide written, informed consent to study participation
* Has access to electronic device and internet to complete sessions conducted on videoconferencing platform

Exclusion Criteria:

* Prior or current treatment with clozapine (clozapine therapy includes additional medication-related monitoring and clinical visits that may impact medication adherence)
* Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial
* Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist
* Immediate risk of harm to self or others
* Female who is currently pregnant or breastfeeding
When Closing Midline Incisions, do Small Stitches Reduce the Risk for Incisional Hernia, Wound Infection or Dehiscence?

The purpose of this study is to determine whether a technique using very small stitches when closing a midline incision can reduce the risk for wound complications such as incisional hernia, infection or dehiscence.

Most abdominal surgical operations are made through a midline incision and 10% of the patients may get a wound infection. Infection is a risk factor for incisional hernia, which 12 months after the operation can be seen in 10-20% of the patients. Wound dehiscence is seen in approximately 1% of the patients. Surgery because of incisional hernias are common and in Sweden approximately 2000 patients per year needs an operation creating big costs. We know that a midline incision should be closed using a continuous technique, with a suture length to wound length ratio over 4. An earlier interventional study at the Surgical Department in Sundsvall showed that using that technique reduced the risk for hernia with 50%. Subsequent experimental studies indicates that the suture length to wound length ratio should be obtained by small stitches, placed close to each other only incorporating the aponeurosis, and not by large stitches incorporating the complete abdominal wall (mass closure). The hypothesis that midline incisions should be closed with small stitches only incorporating the aponeurosis has to be tested in a clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient with an acute or planned operation trough a midline incision at the Surgical Department in Sundsvall, Sweden

Exclusion Criteria:

* Age under 18
* Previous surgery through a midline incision
* Scars from previous surgery crossing the midline
* Preexisting hernia in the midline (umbilical, epigastric)
Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer

The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB or IV NSCLC
* Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC
* At least one target lesion that is unirradiated and measurable by RECIST
* Adequate hematologic, renal and hepatic function
* ECOG 0, 1, or 2
* Able to understand and sign an Informed Consent

Exclusion Criteria:

* Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
* Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
* History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 5 years
* Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
* Serious active infection
* Psychiatric illness/ social situations that would limit study compliance
* Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
* Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
* Known HIV positive or on active anti-retroviral therapy
* Known Hepatitis B surface antigen positive or hepatitis C positive
* Receipt of any investigational medication within 4 weeks prior to randomization
* Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
* Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
* Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
Effects of DPP4 Inhibitor Versus SGLT2 Inhibitor

Type 2 diabetes mellitus (type 2 DM) is an important disease with increasing prevalence worldwide. More than 60% of diabetes patients die of CVD. Diabetes is associated with 2-to 4- fold increase in the risk of coronary artery disease (CAD). Diabetes patients with stable ischemic heart disease may have more prevalent of asymptomatic ischemia or silent ischemia due to autonomic neuropathy. Therefore, detection of total myocardial ischemia including both symptomatic and silent ischemia using ambulatory electrocardiogram monitoring may provide better accuracy in ischemic burden and prognosis in diabetes patients. DDP-4 inhibitors have favorable effects on atherosclerotic risk factors beyond glycemic control. Furthermore, DPP-4 inhibitors may have favorable effects on ischemic preconditioning in patients with CAD. For this study we aim to compare the effects of between vildagliptin and Dapagliflozin on ischemic burden defined by total ischemic time, markers of autonomic function, biomarkers of myocardial injury and biomarkers of inflammation.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (age \> 21), male or non-child bearing potential female
2. Inadequately controlled type 2 diabetes with at least half maximum dose of metformin (HbA1C \> 6.5 and \< 9.0%)
3. Stable documented CAD defined as the followings:

   1. Stable angina with \> 70% stenosis of at least one major epicardial artery from coronary angiogram (CAG) or coronary CTA
   2. Post myocardial infarction (\> 30 days)

Exclusion Criteria:

1. Significant renal function (eGFR \< 30ml/min)
2. Significant hepatic impairment or ALT/AST elevations beyond X2 upper normal limit or known hepatic failure
3. Planned coronary intervention or planed surgical intervention (PCI or CABG)
4. Recent (\<30 day) acute coronary syndrome (ACS)
5. Hypersensitivity to either of the study drug components
6. History of lactic acidosis
7. Type 1 diabetes
8. Current HbA1c \>9%
9. Current Insulin treatment
10. Active treatment with GLP-1 or other DPP4i medication
11. Inability to comply with study protocol
12. Active malignancy other than basal cell carcinoma
13. Clinically advanced congestive heart failure - NYHA III-IV
14. Severe left ventricular dysfunction (LVEF\<25%)
15. Recent heart failure decompensation (\<3 months)
16. Chronic inflammation (i.e. inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection)
17. Pregnancy, lactation or child-bearing potential
Study of Genes and the Environment in Patients With Ovarian Cancer in the East Anglia, Oxford, Trent, or West Midlands Regions of the United Kingdom

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This study is looking at genetic susceptibility for cancer and interactions between genes and the environment in patients with ovarian cancer.

OBJECTIVES:

* To obtain epidemiological information and biological material on a population-based series of ovarian cases.
* To define the proportion of ovarian cancer incidence attributable to mutations in known predisposing genes (e.g., BRCA1 and BRCA2).
* To determine the risk associated with predisposing mutations by examining the cancer risks in relatives of patients who are shown to be carriers.
* To examine the effect of nongenetic risk factors in mutation carriers.
* To determine the pathological and clinical characteristics of ovarian cancers occurring in BRCA1/2 mutation carriers as compared with that in noncarriers.
* To establish whether mutations at other loci may predispose to ovarian cancer by comparing the frequency of alterations in ovarian cancer patients with that in cancer-free controls identified through the European Prospective Investigation of Cancer (EPIC) study.

OUTLINE: This is a multicenter study.

Patients complete an epidemiological questionnaire. The questionnaire will request identifying information on the patient's first-degree relatives.

Blood samples are collected from patients. DNA is extracted from these blood samples and from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL as well as from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.

In addition to the ovarian cancer patients recruited for this study, patients with breast, endometrial, prostate, colorectal, bladder, kidney, pancreatic, brain and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited in the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-PROSTATE, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of ovarian cancer within the past 5 years
* Identified through the East Anglia, Stoke and West Midlands Cancer Registries serving any of the following geographic regions of the United Kingdom:

  * East Anglia
  * Oxford
  * Trent
  * West Midlands

PATIENT CHARACTERISTICS:

* Identified by the patient's general practitioner as fit to contact for this study
* No serious mental illness or retardation

PRIOR CONCURRENT THERAPY:

* Not specified
Online Platform for Healthy Weight Loss (POEmaS)

Clinical trial to test the efficacy of an online platform based on behavior change principles in promoting weight loss among overweight and obese students and employees of the Federal University of Minas Gerais. The hypothesis is that participants of the group which use the platform with or without a dietitian coaching will lose more weight than those allocated to the group who receives dietary and physical activity orientations by educational videos only.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index \>=25 kg/m2
* intention to lose weight by healthy lifestyle habits
* internet access

Exclusion Criteria:

* pregnancy
* diabetes
* heart failure
* coronary artery disease
* kidney disease
* hepatic disease
* cancer
* phenylketonuria
* celiac disease
* food allergies
* bariatric surgery history
* participation in any other weight loss program
Registry of Hypogonadism in Men

The primary objective of the Registry of HYpogonadism in MEn (RHYME) is to establish and maintain a large, multi-national prospective registry of male patients who have been diagnosed with male hypogonadism (HG), also known as androgen deficiency or testosterone deficiency.


Eligibility Criteria:
Inclusion Criteria:

1. Male patients aged 18 years and older.
2. Diagnosis of hypogonadism including Klinefelter's or late onset HG. Patients may have been diagnosed at any point in their lives. Documentation of the diagnosis of HG (including symptomatology and laboratory values including testosterone levels confirmed on two separate occasions) is required.
3. Written informed consent.

Exclusion Criteria:

1. Any previous treatment with testosterone therapy.
2. History of breast cancer, prostate cancer, or high-grade prostatic intraepithelial neoplasia.
3. Prior radical prostatectomy.
4. Life expectancy shorter than 24 months as judged by the Clinical Site investigator.
5. Current major psychiatric disorders or drug or alcohol abuse, which will likely affect participation or compliance in the Registry, in the opinion of the Clinical Site Investigator.
6. Gender dysphoria or sexual reassignment (e.g., transexualism).
7. Patients actively enrolled in any interventional clinical trial.
8. Planned relocation outside Clinical Site region within 24 months.
Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial

Rationale: Management of blood pressure (BP) in the acute phase of intracerebral hemorrhage (ICH) remains controversial. Although it has been established that there is a transient moderate reduction of perihematoma cerebral blood flow (CBF) in acute ICH, the effect of BP treatment is unknown. The potential for exacerbation of CBF has precluded routine aggressive BP reduction.

Aim and Hypothesis: The primary study aim is to demonstrate the feasibility and safety of acute BP reduction to \< 150 mmHg systolic using a standardized protocol in ICH patients. It is hypothesized that CTP will not demonstrate evidence of perihematoma ischemia following acute BP reduction.

Design: ICH ADAPT is a randomized blinded endpoint trial. Acutely hypertensive ICH patients are randomized to a target systolic BP of \< 150 mmHg or \< 180 mmHg. Patients are treated with intravenous (IV) labetalol/hydralazine/enalapril.

Study Outcomes: The primary outcome is cerebral blood flow in the perihematoma region, measured with CT perfusion, 2 hours after randomization. Secondary outcomes include the difference in BP at 1 and 2 hours post-randomization in the two treatment groups and hematoma expansion rates at 24 hours.

Discussion: ICH ADAPT is the only randomized trial designed specifically to identify any hemodynamic changes in the perihematoma region secondary to aggressive BP management. The results of this trial will facilitate ongoing and future studies aimed at determining the efficacy of rapid BP reduction in acute ICH.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Acute primary ICH demonstrated with CT scan
* Onset ≤ 24 h prior to randomization

Exclusion Criteria:

* Contraindication to BP reduction i.e., severe arterial stenosis or high-grade stenotic valvular heart disease
* Indication for urgent BP reduction i.e., hypertensive encephalopathy, or aortic dissection
* Definite evidence that the ICH is secondary to underlying cerebral or vascular pathology, i.e., AVM, aneurysm, tumour, trauma, vasculitis, or hemorrhagic transformation of an ischemic infarct
* Previous ischemic stroke within 30 days of current event NB: Prior ICH is not an exclusion criterion
* Planned surgical resection of hematoma NB: Extraventricular Drain placement is not an exclusion criterion
* Contraindication to CT perfusion imaging (i.e. contrast allergy, metformin use or Creatinine \>160 μmol/l)
Clinical Trial to Evaluate the Safety and Efficacy of JTM201 to Treat Moderate or Severe Glabellar Lines

This is Multicenter, Randomized, Double-blind, Placebo-controlled, Single-dose Study to evaluate Safety and Efficacy of JTM201 in patients with Moderate or Severe Glabellar Lines

This is Multicenter, Randomized, Double-blind, Placebo-controlled, Single-dose Study to evaluate Safety and Efficacy of JTM201 in patients with Moderate or Severe Glabellar Lines. Treatment period is 180 days and evaluation of the safety is the primary endpoint

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥18 years of age based on the date of the written informed consent form.
* Subject is able to provide written informed consent and comply with study procedures.
* Subject has moderate or severe glabellar lines on maximum frown as assessed by the investigator and subject using the GLS (score of 2 or 3).

Exclusion Criteria:

* Previous insertion of permanent material in the glabellar area including the forehead.
* Planned treatment with botulinum toxin of any serotype in any other body region during the study period.
* Pregnant or breastfeeding (directly or via pump); or planning to become pregnant during the study.
* Known allergy or hypersensitivity to botulinum toxin or product excipients.
* Participation in another interventional clinical study ≤30 days of Visit 1: Screening.
* Planning to donate, bank, or retrieve eggs (ova, oocytes) or donate sperm during the study.