cyrilzakka/clinical-trials huggingface dataset:
IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium.

The purpose of this study is to test the impact of pharmacological myocardial metabolic support, in the form of intravenous (IV) glucose, insulin and potassium (GIK), for the treatment of patients with threatened or established acute myocardial infarction (AMI).

BACKGROUND:

Basic and clinical research suggests intravenous GIK metabolic myocardial support reduces ischemia-induced arrhythmias, progression from unstable angina pectoris (UAP) to acute myocardial infarction (AMI), myocardial infarction (MI) size, and mortality. Also, for ST elevation MI (STEMI), GIK may prolong time of benefit of coronary reperfusion. These effects should reduce short- and long-term mortality from ACS, including AMI and UAP, and the propensity for heart failure (HF). These benefits are related to the earliness of ACS, when both risk and opportunity to save lives are highest.

DESIGN NARRATIVE:

This is a randomized, placebo-controlled, double-blinded, multicenter clinical trial of IMMEDIATE GIK as early as possible in ACS in the prehospital emergency medical service (EMS) setting. Distinct from prior and ongoing GIK trials, this will test GIK for all ACS rather than only for AMI or STEMI in prehospital EMS. The primary hypothesis is that early GIK will prevent or reduce the size of acute myocardial infarction. Major secondary hypotheses posit GIK will reduce mortality (30 days and 1 year), reduce pre- or in-hospital cardiac arrest and the propensity for heart failure. Other hypotheses address mechanisms of these effects.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of threatened or established AMI including but not limited to:

  1. Chest pain, discomfort, or tightness
  2. Arm or shoulder pain
  3. Jaw pain
  4. Epigastric discomfort
  5. Shortness of breath
* 12-lead electrocardiogram (ECG) with two or more contiguous leads with ST elevation greater than 1 mm, ST depression greater than 0.5 mm, T wave inversion or other T wave abnormalities (hyperacute T waves), or left bundle branch block (not known to be old). Identification aided by the acute cardiac ischemia time-insensitive predictive instrument (ACI-TIPI)and thrombolytic predictive instrument (TPI) decision support software (ACI-TIPI \>= 75% and TPI detection of suspected STEMI).

Exclusion Criteria:

* End-stage kidney failure requiring dialysis
* Rales present more than halfway up the back
* Unable to comply with the requirements of the study
* Incarcerated
* Known to be pregnant
Differential Effects of Intimate Partner Violence (IPV) on Mental Health

The purpose of this study is to extend the extant work on the typology of intimate partner violence (IPV) by employing mixed methods to collect quantitative and qualitative data.

Although post-traumatic stress disorder and depression have been identified as the two most common consequences of intimate partner violence, research has generally not differentiated the effects of different types of intimate partner violence on victim's mental health. With intimate partner violence treated as a single phenomenon rather than having different types, abused women are unlikely to receive the most appropriate interventions.

Johnson's typology of control has been used increasingly to classify intimate partner violence based on physical assault and controlling behavior. Two distinct types of the violence, Intimate Terrorism and Situational Couple Violence, have received much attention. The two differ not only in the cause and trajectory of the violence but also in the effects including mental health outcomes. Although control is a critical factor in distinguishing intimate terrorism from situational couple violence, there is no consensus on what constitutes high or low control in physically violent intimate relationships. Partly, this may be due to the sole reliance on quantitative measures to determine the levels of control. By understanding the context in which control tactics are used, qualitatively different phenomena between violent relationships with high control and those with low control may be more apparent. Thus, there is a need to collect both quantitative and qualitative data on the use of controlling behaviors.

It has also been hypothesized that intimate terrorism and situational couple violence have different mental health outcomes but few studies have examined this empirically and none has studied women's experiences of the negative psychological consequences as victims of these two types of violence.

Eligibility Criteria:
Inclusion Criteria:

* Chinese women, aged 18 or above, from a shelter or a community centre, and screened positive for IPV in the past 12 months

Exclusion Criteria:

* Unable to communicate in Cantonese or Putonghua
* The perpetrator is not an intimate partner
The Effects and Cost-Effectiveness of an Integrated Multidisciplinary Approach for Psychogeriatric Patients

The purpose of this study is to determine the effects and cost-effectiveness of a Diagnostic Observation Center for PsychoGeriatric patients (DOC-PG). Our main hypothesis is that DOC-PG has added value compared with usual care regarding Health Related Quality of Life (HRQoL).

An integrated multidisciplinary approach to diagnosing and managing dementia is generally recommended, though rarely investigated. In recent years, multidisciplinary memory clinics (MCs) for patients with dementia have been established in many places over the world. These services have recently also been criticised for being principally hospital-based, for their apparently limited focus that entails only medical diagnostics and pharmacotherapy and for thus diverting resources from community mental health teams(CMHTs) .On the other hand, CMHTs are mainly concerned with the provision and organisation of integrated care, and unlike MCs, CMHTs generally have limited access to hospital-based diagnostics such as brain-imaging.

In April 2002, an outpatient diagnostic facility, the Diagnostic Observation Centre for PsychoGeriatric patients (DOC-PG) was established in Maastricht, the Netherlands. DOC-PG combines the hospital-based approach of the MC with the care-oriented approach of the regional CMHT and aims to provide the general practitioner (GP) with elaborate diagnostic and therapeutic advice for patients with cognitive disorders.

Comparison: DOC-PG is compared with usual care i.e. the GP took care of the diagnosis, or he or she referred the patient to one of the separate regional services, e.g. the Maastricht Memory Clinic (MMC), geriatric medicine, or the department of mental health for the elderly of the mental health community service (CMHT).

Eligibility Criteria:
Inclusion Criteria:

* Aged 55 years or over
* Suspected of having dementia or combined somatic/psychiatric disorder
* No referral to other local/regional services in the last two years
* Availability of a proxy (visiting the patient at least once a week)

Exclusion Criteria:

* Acute disorders that need a prompt therapeutic intervention
* Living in a nursing home or receiving care that is comparable to that of a nursing home
Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age

The primary objective of the study was to compare the growth parameters of children approximately 2\* years of age, who as infants were randomized to receive either a lower-protein formula ("experimental formula"; EF) with 12.8 g/L protein or a standard formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of life. The secondary objective was to describe diet and nutrient intake in this cohort of children. The exploratory objectives were to describe stool microbiota in a subset of this cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and minerals) in a second subset of this cohort.

(\* The mean age of subjects was 33.0 months due to a delay in the study start-up.)

This was an observational, single-site, follow-up study of healthy children who as infants who had completed study 9052A1-3000. An attempt was made to contact all subjects who had completed study 9052A1-3000 by telephone to ask them to participate in study 9052A1-3001. Approximately 66 and 60 subjects were planned to participate in the stool microbiota and stool composition substudies, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Children who were enrolled in the Wyeth Nutrition study are eligible to participate in this study

Exclusion Criteria:

* Children who were not enrolled in the Wyeth Nutrition study are not eligible to participate in this study
* Children who have received any antibiotics and antifungal medications except topical within two weeks prior to enrollment are not eligible to participate in the stool microbiota study
* Children who are taking any medications known or suspected to affect fat digestion, absorption, and or metabolism, any vitamin and or mineral supplements which contain calcium, suppositories, bismuth-containing medications, herbal supplements, or medications that may neutralize or suppress gastric acid secretion, are not eligible to participate in the stool composition study
Immunological Responses of COVID-19 Vaccination

Cancer patients with COVID-19 have a 30% higher mortality rate compared to the general population and are considered a high-risk group by the American Association for Cancer Research that should be given "high priority" during COVID-19 vaccine administration. Although studies have suggested that vaccination during active treatment with chemo and/or radiation therapy provides suboptimal antibody response, the studies were underpowered and heterogeneous thus putting this conclusion into question. We need data in cancer patients on immunosuppressive chemotherapy at the time of COVID vaccination to understand how immune responses compare to healthy controls and cancer patients not on immunosuppressive therapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants must meet all of the following inclusion criteria to be eligible for enrollment:

  1. Willing and able to provide written informed consent for the trial.
  2. Male or female participants \>18 years of age on the day of signing informed consent.
  3. a. Participants (\>18 years) with gastrointestinal (gastroesophageal, pancreatic, small bowel, colon, anal) solid tumors, breast, or prostate cancers who received myelosuppressive chemotherapy within 60 days prior to initial or booster COVID vaccination, or who started on chemotherapy within 60 days after the initial or booster COVID vaccination; or b. Adult participants (\>18 years) not receiving chemotherapy at the time of initial or booster COVID vaccination, but who were on non-immunosuppressive treatments (endocrine therapy, treatment with tyrosine kinase inhibitor or antiHER-2 therapy); or c. Adult participants \> 18 years either: (i) with no history of cancer or (ii) prior history of non-metastatic solid cancer invasive cancer treated with a curative intent, without evidence of disease recurrence, and \>12 months from completion of chemotherapy or radiation.
  4. a. Participants in groups A and B who have a planned COVID vaccination within the next 90 days of study enrollment with any FDA approved vaccine, or previous COVID vaccination within 90 days from study enrollment are eligible provided they meet all other above eligibility criteria; or b. Participants in group C who have planned COVID vaccination within the next 90 days of study enrollment with any FDA approved vaccine; or previous COVID vaccination within six months from study enrollment are eligible provided they meet all other above eligibility criteria

Exclusion Criteria:

* Participants will be considered ineligible for enrollment with the following criteria:

  1. Participants currently on immunotherapy
  2. Participants with documented COVID 19 infection within \< 6 months from study enrollment
  3. Prior history of autoimmune disorder and are currently on immunosuppressive therapy or have received immunosuppressive therapy within the last 6-12 months prior to enrollment
  4. No planned and no prior COVID vaccination
XGBoost for Predict Incisional Hernia

The objective of this study is to develop a predictive model of IH based on machine learning with the use of the XGBoost technique, this will help surgeons in charge of abdominal wall closure to have objective support to determine high-risk patients and in them modify the closure technique or use a mesh according to their choice or the degree of contamination of the abdominal cavity.

Retrospective and observational study. The predictions will make using machine learning models. The programs use the scikit-learn, xgboost and catboost Python packages for modeling.

The evaluation of models will be using fourfold cross-validation, the receiver operating characteristic (ROC) curve, the area under the ROC curve (AUC), and accuracy metrics calculated on the union of the test sets of the cross-validation.

The most critical factors and their contribution to the prediction will identify using a modern tool of explainable artificial intelligence called SHapley Additive exPlanations (SHAP).

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age
* Postoperative midline exploratory laparotomy, who underwent urgent or scheduled surgery, regardless of their underlying diagnosis,
* included between January 2010 and December 2016 and who completed 24 months of follow-up after surgery initial surgery.

Exclusion Criteria:

* Reoperated for any cuestion diferent to present of hernia
* Management of open abdomen
Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients

The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIT45 compared to the current standard of care in postpartum patients.

This is an open label Phase III randomized active control study of postpartum patients with anemia. Patients will be randomized to either active control or the investigational agent and followed for up to 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Female Subjects able to give consent
* Post partum patients
* Baseline Hgb \< /= 10 g/dL
* Agree to practice birth control

Exclusion Criteria:

* Participation in previous clinical trial of this investigational agent
* Known hypersensitivity reaction to active control
* Significant vaginal bleeding
* History of anemia other than iron deficiency anemia
* Anticipated need for surgery during the study
* Active severe infection or malignancy
* Known positive Hepatitis B antigen of Hepatitis C viral antibody
* Known HIV antibodies
* Received an investigational drug within 30 days of screening
* Alcohol abuse within past 6 months
* Hemochromatosis or other iron storage disorders
* Significant cardiovascular disease
* Any laboratory abnormality, medical condition or severe psychiatric disorder which in the opinion of the investigator woud put the subject's disease management at risk or may result in the subject being able to comply with the study requirements
Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients

The purpose of this study is to evaluate the effect of especial diet therapy "Anti-inflammatory Diet" on inflammatory, oxidative stress, and nutritional markers in the context of protein-energy wasting syndrome(PEW) in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are on hemodialysis(HD) at least two times a week for 3months or more without any internment illness or admission

Exclusion Criteria:

* Hospitalization because of sepsis or surgery 3 months prior to intervention
* Cirrhosis
* Hepatitis virus infection
* Human Immunodeficiency virus infection
* Acquired Immunodeficiency Syndrome
* Active malignancy
* Active infection
* Absence of communication
* Mental Impairment
* Terminal illness
* Tube feedings
* Total parenteral nutrition
* Pregnancy
* Not previously seen by a dietitian within 3 months prior to enrollment in the study
* Not expected to be transplanted within 6 months after the enrollment in the study
* Absence of malnutrition from a cause other than end stage renal disease(ESRD)
* Psychiatric conditions, preventing adherence to intervention
* Consuming immunosuppressive drugs or taking antioxidant supplements including Vitamin E, Vitamin C, N-acetyl- cysteine (NAC), Pentoxifylline, Lipoic acid,Fish-oil extracts (omega-3 fatty acids), Soy extracts(isoflavones), Green-tea preparations, Pomegranate extracts, Grape extracts within 2 months prior to enrollment in the study
Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications

This retrospective study investigates the relationship between cardiopulmonary bypass (CPB) duration and the incidence of gastrointestinal complications (GICs) in patients undergoing heart valve replacement. Patients will be grouped into a normal CPB group (CPB \<120 minutes) and a prolonged CPB group (CPB ≥120 minutes). The study aims to determine whether prolonged CPB time is associated with a higher risk of GICs and to evaluate the outcomes and recovery process for patients who develop GICs postoperatively.

Heart valve replacement with CPB carries a risk of GICs due to potential ischemia-reperfusion injury to the gastrointestinal tract. GICs in the postoperative period can lead to increased morbidity and prolong recovery. Prolonged CPB time may serve as a predictive factor for the development of GICs following heart valve replacement. This study will utilize established diagnostic criteria to define GICs, which include clinical symptoms, laboratory tests, and imaging as necessary, based on standards from critical care and gastrointestinal surgery guidelines. By understanding this correlation, the study aims to reduce the incidence and severity of postoperative GICs and improve surgical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing heart valve replacement with CPB
* Age ≥ 18 years and ≤ 75 years

Exclusion Criteria:

* Have received major gastrointestinal surgery within 5 years.
* History of severe infection (e.g., pneumonia, urinary tract infection) requiring hospitalization within 1 month prior to surgery.
* Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis.
* Acute gastroenteritis.
* Clostridium difficile or Helicobacter pylori infection.
* Chronic constipation.
* Peptic ulcer.
* Polyps in the stomach or intestines.
* Gastrointestinal neoplasms.
* Abdominal hernia.
* Irritable bowel syndrome.
* Acute or chronic cholecystitis, hepatitis.
* Patients who died intraoperatively or within 24 hours postoperatively.
* Patients with digestive system tumors.
* Pregnancy or breastfeeding could affect postoperative medication use and study observations.
* Involvement in other studies that may interfere with the objective results of this study.
Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis

To assess the long-term safety and effectiveness of Nephoxil® for the treatment of hyperphosphatemia in patients with ESRD undergoing dialysis.

This study is an open-label, prospective, long term, Phase IV study to assess the safety and efficacy of Nephoxil® in subjects with ESRD on dialysis.

Eligibility Criteria:
Inclusion Criteria:

1. Is ≧ 18 years of age on the day of signing informed consent or other age required by local regulation
2. Willing and able to provide written informed consent
3. ESRD patients who is undergoing hemodialysis 3 times per week and is considered necessary to receive medication for hyperphosphatemia by his/her treating physician
4. Serum ferritin \<1000 ng/mL and transferrin saturation (TSAT) \< 50% at the Enrollment Visit
5. Women of child-bearing potential (WOCBP \[defined as women ≤ 50 years of age with a history of amenorrhea for \< 12 months prior to study entry\]) who is willing to use an effective form of contraception during study participation

Exclusion Criteria:

1. Has any known contraindication to ferric citrate according to locally approved prescribing information, include but not limited to the following criteria:

   i. Is allergic to ferric citrate ii. Has hypophosphatemia iii. Has hemochromatosis or iron overload syndromes iv. Has active severe GI disorders
2. Has parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT) within 3 months prior to Enrollment Visit or serum calcium \< 7 mg/dL at the Enrollment Visit
3. Has participated in another interventional study for any investigational agent or device within 30 days prior to enrollment
4. Is currently pregnant or breastfeeding
5. Other unstable medical condition or psychiatric conditions that is considered unsuitable for this study per Investigator's clinical judgment
Web-based Screening and Tailored Support

The ever expanding breast cancer survivor population urges the health care system to develop (cost-)effective screening and management of convalescent care needs that can be easily implemented in conventional follow-up care. Internet-delivered systems may be well-equipped to meet these demands. The aim of the current study is to assess the effectiveness of a web-based support system. Key features of this system are patient self-screening of physical and psychosocial problems, tailored patient education on reported problems and self-referral to professional care. In this era of high internet usage, we expect that internet is a highly suitable medium to provide tailored support for breast cancer patients and will empower the patient to take control over their convalescence.


Eligibility Criteria:
Inclusion Criteria:

* Adult female breast cancer patients (aged ≥ 18 years of age).
* Recent completion (≤6 months) of (neo)adjuvant chemotherapy for primary breast cancer
* Ability to comprehend Dutch (both reading and writing).
* Access to internet (e.g. at home, via family or friends)
* Informed consent provided

Exclusion Criteria:

• Chemotherapy treatment with palliative intent or recurrent breast cancer
Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes

Macular schisis associated with macular detachment is a one of the complications of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal detachment associated with macular schisis.

A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on macular schisis associated with macular detachment in eyes with high myopia.

Eligibility Criteria:
Inclusion Criteria:

* axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
* macular schisis
* macular retinal detachment
* evidence of posterior staphyloma on clinical examination

Exclusion Criteria:

* severe macular scar
* macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
* prominent vitreomacular traction
* a history of vitrectomy or macular buckle
* intraocular active hemorrhage or inflammation
* any media opacity which precluded imaging or clinical evaluation of the macula