cyrilzakka/clinical-trials huggingface dataset:
GI Surgery Pre-Operative Nutrition

Surgical patients are high risk for post operative infections. These post operative infections contribute to increased length of hospital stay, hospital costs and delay overall recovery time thus decreasing the quality of life. Studies have reported post operative complications ranging from 37% to 74%.1 The most costly complications include infectious complications after major Gastrointestinal (GI) surgery including wound infections, abdominal abscess, pneumonia, sepsis and anastomic leaks.2 Several studies have been conducted that show a significant reduction in infectious complications and average length of stay when treated with immunonutrition supplements.2-3 A review of similarly designed studies in a different patient population indicate that post-operative infections can be reduced by an average of 71% with immunonutrition.

This study seeks to investigate the effect of Impact Advanced Recovery ® in improving surgical outcomes in patients receiving major gastrointestinal surgeries compared to a standard supplement at James A. Haley Veterans' Hospital. Providing Impact Advanced Recovery ® may decrease post-operative infectious complications, length of stay, and recovery time.

Hypothesis

1. In patients receiving elective gastrointestinal surgery (esophageal, gastric, pancreatic or colon resections) there will be a significant decrease of at least 60% in post-operative infections as listed below for patients who consume 15 servings of Impact Advanced Recovery® pre-operatively compared to patients who consume 15 servings of a standard supplement.

   Complications to be considered: anastomatic leak, post-op wound development, post-op abdominal abscess, sepsis, pneumonia, post-op ileus, intestinal fistula, obstruction, urinary tract infections, peritonitis or bowel necrosis.
2. In patients receiving elective gastrointestinal surgery (esophageal, gastric, pancreatic or colon resections) there will be a significant decrease in hospital and NPO days for patients who consume 15 servings of Impact Advanced Recovery ® pre-operatively.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented neoplasm of the gastrointestinal tract.
* Planned major elective surgery including esophageal, gastric, pancreatic or colon resections.

Exclusion Criteria:

* Critically ill patients defined as any patient admitted to the intensive care unit (ICU) prior to elective surgery.
* Current use of steroids or other immunosuppressive medications.
* History of hospitalization for pulmonary, cardiac or renal disease in the 6 months prior to elective surgery.
* Patients who exhibit signs and symptoms of infection or sepsis including: elevated WBC above 10,000 cells/ml; temperature \> 37.7 C
Pregnancy Weight Management Health Literacy Questionnaire

Worldwide obesity has continued to increase over the past decades. Among the adult women, the overweight and obesity rates in Taiwan are much higher than that of women in nearby Asian countries. In particular, the body mass index of women with low health literacy exceeds the normal range before pregnancy. Without proper supervision, the increase in body weight during pregnancy may result in multiple maternal complications, affect the newborn's health, and increase unnecessary medical expenses in Taiwan's health care system. Thus, assessing pregnant women' s health literacy to manage their body weight is of importance. However, currently, there is no appropriate instrument available in Taiwan to assist health practitioners in assessing the health literacy of pregnant women for weight management. The aim of the study is to develop an instrument to measure the health literacy regarding weight management of pregnant women and examine its psychometric properties.

This study will use a multiphase prospective longitudinal design. While developing the items of the instrument based on the review of the literature, five content experts will be invited to participate in the study for examining the appropriateness of the generated items. Upon the approval of the Institutional Review Board, a convenience sample will be recruited to establish face validity. Then the instrument will be refined according to the report derived from the pretesting. The content experts will then review the revised instrument again, and another 330 primigravida women will be enrolled in the study for assessing the psychometric properties. The validity and reliability of the instrument will be examined through evaluating the internal consistency reliability, split-half reliability, concurrent validity, and predictive validity. Health practitioners can use this newly developed instrument to assess pregnant women's health literacy to help manage their weight gain during pregnancy. By utilizing this instrument, health practitioners can provide individually tailored nursing care to improve the effectiveness of their weight management.

Eligibility Criteria:
Inclusion Criteria:

* Primigravida women
* Fluent in writing, reading and speaking Mandarin

Exclusion Criteria:

* Non-pregnant
* Can't fluent in writing, reading and speaking Mandarin
* Cognitive dysfunction
Combined Exercise and Nutritional Intervention in GI Cancer Patients

Although some studies have focused on the role of exercise on inflammation and cytokine expression in cancer patients undergoing treatment and survivors, to our knowledge none have investigated the effect of exercise during neoadjuvant treatment as a complementary therapy to 1) modulate inflammation which may have a positive influence on chemotherapy response and 2) preserve or improve skeletal muscle, thus preventing cancer cachexia. Furthermore, we believe that the neoadjuvant treatment period could be a window of opportunity to optimize patient's nutritional status before surgery, which until now has been under used.

Bearing in mind that nutritional interventions may also influence IL-6, our hypothesis is that a Combined Exercise and Dietary Intervention (CEDI) may induce positive alterations in cytokine profile and increase NK cell infiltration of the tumor in gastric and pancreatic cancer patients submitted to neo-adjuvant therapy.


Eligibility Criteria:
Inclusion Criteria:

* gastric or pancreatic cancer stage II/III, eligible for neoadjuvant chemotherapy,
* age higher than 40 years and lower than 80 years,
* ECOG (Eastern Cooperative Oncology Group) functional status: 0-2,
* sedentary/low physical activity level.

Exclusion Criteria:

* life expectancy less than 12 months at inclusion,
* chemotherapy regimen other than 5-Fluorouracil, Folinic acid, Oxaliplatin, Docetaxel (FLOT) for gastric and 5-Fluorouracil, Irinotecan and Oxaliplatin (FOLFIRINOX) or gemcitabine for pancreatic cancer,
* metastatic disease,
* chronic anti-inflammatory medication use,
* known inflammatory condition (rheumatoid arthritis, ankylosing spondylitis or chronic active hepatitis)
* cardiovascular, respiratory or musculoskeletal or joint problems that preclude moderate physical activity.
Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden

The goal of this clinical trial is to compare the efficacy and safety of intracoronary rhTNK-tPA or Tirofiban in patients with ST-segment elevation myocardial infarction and high thrombus burden. The main questions it aims to answer are:

* Is the efficacy of intracoronary rhTNK-tPA non-inferior to intracoronary Tirofiban for the treatment of ST-segment elevation myocardial infarction in patients wiht high thrombus burden?
* Does intracoronary rhTNK-tPA increase the incidence of bleeding events?

This multicenter RCT study plans to enroll 300 patients, who are randomly divided into two groups: intracoronary rhTNK-tPA or Tirofiban by 1:1. The primary efficacy endpoint was post-PCI corrected TIMI frame count (CTFC). Major adverse events (death, recurrent myocardial infarction, ischemic stroke, or hospitalization for heart failure) were observed at 1 year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old;
* STEMI within 12 hours of onset;
* TIMI flow grade 0-2 or TIMI thrombus grade ≥4 after thrombus aspiration or balloon dilation
* Radial artery access

Exclusion Criteria:

* A functional coronary collateral supply (Rentrop grade≥2) to the infarctrelated artery
* Known or suspected old myocardial infarction of target vessels
* Rescue PCI
* Cardiogenic shock
* Contraindications to Tirofiban or rhTNK-tPA
* Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate \<30ml/min/1.73m2, or on dialysis)
* Prolonged (\> 10 minutes) cardiopulmonary resuscitation
* Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall)
* Severe chronic obstructive pulmonary disease or respiratory failure
* Severe infection
* Neurological disorders
* Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year
* Pregnant or lactating women
Blue-green Space Physical Activity: the "Parco Del Mare" Study

This study protocol, describe the innovative study intervention which will be performed in a green-blue space in Italy in order to investigate on the improvements in wellbeing following participation in the study. This will be significant because it will provide evidence on the effectiveness of the supervised physical activities carried out in green-blue space in improving health, quality of life, physical performance, anthropometric outcomes and physiological parameters in adults, indicating the reasonableness for public health authorities to developing such activities.

The aim of the "Parco del Mare" pilot study is to evaluate the feasibility and the effects of a moderate-intensity exercise program carried out in a green-blue space, on health outcomes such as quality of life and physical performance. Healthy adults with no contraindication to practice physical activity will be recruited and divided into two groups: the experimental group involved in the exercise sessions performed twice a week for 6-months, while the control group received no intervention. Validated tests and questionnaires will be used to detect health parameters at baseline (T0) and follow-up (T1). The investigators expected the intervention carried out in the Parco del Mare setting to be feasible and effective in improving health parameters, quality of life and physical performance in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Adult population aged \>18 years old
* Resident in Rimini

Exclusion Criteria:

* Any alterations in communication skills and/or sensory functions so severe as to make it impossible to understand and/or execute the instructions given by the trainer (dementia, aphasia, blindness, deafness)
An Optional Two Year Follow Up Study to Study CP005A

Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma.

The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who completed all dosing visits in study CP005 and all visits in study CP005A approximately two years after the start of treatment.

Subjects who completed all visits in studies CP005 and CP005A will be invited to attend the Screening Visit for CP005B. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit is a follow-up visit which will be performed 3-10 days later.

Eligibility Criteria:
Inclusion Criteria:

- Previously randomised into study CP005 and completed all visits in the follow-on study CP005A

Exclusion Criteria:

* "Partly controlled" and "uncontrolled" asthma
* History of anaphylaxis to cat allergen
* Subjects with an FEV1 \< 70% of predicted
* Subjects who cannot tolerate baseline challenge in the EEC
* Treatment with beta-blockers, alpha-adrenoceptor blockers, tranquilizers, or psychoactive drugs
* Symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit
The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)

To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) in HIV-infected adult patients without clinical manifestations of disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Prior history of a malignancy other than cutaneous basal cell or cervical carcinomas.
* Other significant, chronic underlying medical illness which would impair study completion.
* Liver dysfunction as demonstrated by lab results.
* Laboratory evidence of compromised bone marrow function.

Concurrent Medication:

Excluded:

* Any other experimental agents.
* Any probenecid-containing product.

Patients are excluded if they have a history of symptoms characteristic of CDC class I or IV including any of the following:

* Unintentional weight loss of greater than 10 lbs, or more than 10 percent of usual body weight within the last 16 weeks.
* Unexplained fever \> 38.5 degrees C on more than 14 consecutive days or on more than 15 days in the previous 30-day period.
* Unexplained diarrhea defined by = or \> 2 liquid stools per day persisting for = or \> 14 days or 15 days in any 30-day period.
* OR History of secondary infections associated with AIDS related complex (ARC) including:
* Recurrent oral candidiasis documented by morphology or by response to antifungal therapy within 3 years.
* Herpes zoster infection within 3 years.
* Oral hairy leukoplakia at any time.
* OR History of opportunistic disease fulfilling the CDC surveillance definition of AIDS.
* Signs and symptoms at baseline characteristic of acute HIV disease (CDC group I).
* Evidence of significant neurologic dysfunction as currently defined by CDC following standard neurologic screening and AIDS Dementia Assessment.

Prior Medication:

Excluded:

- Previous treatment for greater than 3 months duration with any antiretroviral compound such as zidovudine (AZT).

Excluded within 4 weeks of study entry:

- Treatment with any potentially myelosuppressive drug, nephrotoxic agent, or other experimental therapy.

Excluded within 3 months of study entry:

- Antiretroviral drugs or biologic response modifiers.

Excluded within 4 months of study entry:

- Systemic corticosteroids.

Patients must meet the following criteria:

* HIV infection demonstrated by ELISA and confirmed by Western blot.
* Signs and symptoms of HIV disease limited to those characteristic of CDC groups II (asymptomatic) and III (persistent generalized lymphadenopathy - PGL).
* Ability to give informed consent.
* Willingness to be followed by the originating medical center for the entire 3-year duration of the study.

Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia

The main question this study is trying to answer is whether lumateperone, an FDA-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol.

Participants will be randomly assigned to either take lumateperone (Caplyta) or a placebo for 12 weeks, in addition to their regularly prescribed clozapine. During their participation, patients will answer questions about their psychiatric and daily functioning, have blood drawn, and have their body composition analyzed (similar to stepping on a scale).

This is a 12-week study in which we investigate how adjunctive lumateperone affects lipid particle size and body composition in clozapine-treated patients with schizophrenia; in addition, we will investigate if lumateperone improves insomnia. Outcome measures will record a variety of assessments related to participants' psychiatric symptoms, psychosocial functioning, and biological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder based on the MINI International Neuropsychiatric Interview (MINI 7.0)
* On clozapine treatment for at least 6 months
* Stable dose of antipsychotic treatment for at least 1 month
* Well established compliance with outpatient medications
* Subjects of child-bearing potential are required to practice appropriate birth control methods during the study.

Exclusion Criteria:

* Psychiatrically unstable per clinical judgement by the principal investigator
* Patients not on stable dose of antipsychotic medications
* Currently meets DSM-5 criteria for any substance use disorder other than caffeine and nicotine
* Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases
* History of a seizure disorder
* Pregnancy or breastfeeding
* On lumateperone treatment in the past 3 months
* On a dopamine partial agonist antipsychotic agent in the past 3 months (aripiprazole, brexpiprazole, cariprazine)
A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults (18 years and older) with autism spectrum disorder (ASD).


Eligibility Criteria:
Inclusion Criteria:

* Subject meets the DSM-5 criteria for ASD for an autism diagnosis and is confirmed using ADOS-2 criteria
* SRS-2, proxy version, total t-score \>=66 at screening
* A full scale IQ score \>=70 on the WASI®-II
* Subject has an appropriate study partner, in the opinion of the investigator
* For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of \<1% per year during the treatment period and for at least 28 days after the last dose of study drug
* Treatment with permitted medications (at a stable dose for 12 weeks before screening) and behavioral therapy regimens (regimens stable for 6 weeks before screening), with the intent that such treatments remain stable throughout the study and with no expected changes before the Week 24 visit

Exclusion Criteria:

* Pregnancy or breastfeeding, or intention to become pregnant during the study
* Previous initiation of new or major change in psychosocial intervention within 6 weeks prior to screening
* Unstable or uncontrolled clinically significant affective or psychotic disorders and/or neurologic disorder that may interfere with the assessment of safety or efficacy endpoints
* Substance use disorders during the last 12 months
* Significant risk for suicidal behavior, in the opinion of the investigator
* Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
* Clinical diagnosis of peripheral neuropathy
* Within the last 2 years, unstable or clinically significant cardiovascular disease
* Uncontrolled hypertension
* Unexplained syncopal episode within the last 12 months
* Confirmed elevation above upper limit of normal of CK-MB, high sensitivity cardiac troponin T, cardiac troponin I, and/or N-terminal pro B-type natriuretic peptide
* Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2
* History of coagulopathies, bleeding disorders, blood dyscrasias, hematological malignancies, myelosuppression (including iatrogenic), or current major bleeding event
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or what would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
* Confirmed clinically significant abnormality in parameters of hematology
* Confirmed clinically significant abnormality in parameters of clinical chemistry, coagulation, or urinalysis
* Medical history of malignancy, if not considered cured
Neuroimaging GABA Physiology in Fragile X Syndrome

The investigators wish to compare the brain distribution of GABA(A) receptors and GABA levels in young adult males with Fragile X Syndrome compared to idiopathic intellectual developmental disorder. The radiopharmaceutical \[18F\]flumazenil has been used to study GABA(A) receptor distribution in other genetic syndromes with autistic features; however, despite overwhelming evidence supporting the importance of the GABAergic system in FXS, no clinical investigation of this system in human FXS has been reported in the literature. Therefore, this study will provide the first in vivo comprehensive examination of the GABAergic system in FXS using hybrid positron emission tomography/ magnetic resonance imaging (PET/MRI).

Fragile X syndrome (FXS) is the most common genetic cause of autism spectrum disorder (ASD). Converging evidence suggests that GABAergic dysfunction occurs in FXS. The investigators wish to examine brain distribution of GABA (A) receptors in young adult males with FXS using hybrid PET/MRI with \[18F\]flumazenil. This project will study the distribution of GABA(A) receptors in 15 young male adults with FXS (18-30 years old) compared to 15 age-matched male subjects with idiopathic intellectual developmental disorder (IDD) as controls. Simultaneous PET/MRI acquisition is an optimal technique to study in vivo GABAergic dysfunction and GABAa receptor distribution.

Eligibility Criteria:
Inclusion Criteria for participants with FXS:

1. Have an established diagnosis of FXS (full mutation with aberrant FMR1 methylation) by genetic testing
2. Diagnosis of intellectual disability
3. Males who are physically healthy
4. Age 18 to 30 years inclusive
5. IQ between 40 and 80 points
6. Ability to remain seated for more than 10 minutes
7. Ability to travel to Stanford

Exclusion criteria for participants with FXS:

1. Diagnosis of a known genetic disorder (other than FXS).
2. Active medical problems such as unstable seizures, congenital heart disease, endocrine disorders.
3. Significant sensory impairments such as blindness or deafness.
4. DSM-5 diagnosis of other severe psychiatric disorder such as bipolar disorder or schizophrenia.
5. Pre-term birth (\<34 weeks' gestation) or low birth weight (\<2000g).
6. Current use of benzodiazepines.
7. Contraindication for PET or MRI.

Inclusion criteria for participants with IDD:

1. Age 18 to 30 years inclusive
2. Adults who are physically healthy
3. No significant recent changes in psychosocial stressors per history
4. Diagnosis of intellectual disability
5. IQ between 40 and 80 points
6. Ability to remain seated for more than 10 minutes
7. Ability to travel to Stanford

Exclusion Criteria for participants with IDD:

1. Genetic diagnosis of FXS.
2. Active medical problems such as unstable seizures, congenital heart disease, endocrine disorders.
3. Significant sensory impairments such as blindness or deafness.
4. DSM-5 diagnosis of other severe psychiatric disorder such as bipolar disorder or schizophrenia.
5. Pre-term birth (\<34 weeks' gestation) or low birth weight (\<2000g).
6. Current use of benzodiazepines.
7. Contraindication for PET or MRI.