cyrilzakka/clinical-trials huggingface dataset:
Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings

Comer en Familia is a psychoeducational intervention in nutrition aimed to improve nutritional status in families, particularly mothers and caregivers of children between the ages of 5 and 13 years and their children through providing healthy cooking lessons in their communities where the optimal preparation and use of local foods based on vegetables is promoted at the same time the importance of cooking at home and eating as a family is highlighted.

It is well known that in order to promote a proper nutrition and to prevent malnutrition in Mexican population, both by deficiencies and excesses, it is essential to recover Mexican food culture. It is known that only information is insufficient to implement healthy lifestyles. There are a number of barriers that interfere with the adoption of healthy dietary practices that need to be identified and addressed in order to achieve the adoption of healthy eating behaviors. Therefore, Comer en Familia focuses on the people, their lifestyles, motivations and social context, based on an action methodology. To design the program, culinary traditions from different country regions were integrated, the habits of proper food preparation at home, promoting eating in the company of family with special emphasis on the importance of enjoying the taste of food were also integrated. This model delivers information on the transcendence of preparing food at home, the impact of nutrients on health and the influence of eating habits of the family in the conducts of their members in a practical way. Comer en Familia is a nutritional educational model that aims to promote proper nutrition, and therefore improve health and welfare of the beneficiaries of food banks. Through 24 cooking workshops throughout a period of a year, each workshop every 15 days, communities will be trained in optimal food preparation and the use of local food, based mainly on vegetables, while promoting the importance of cooking and having family meals. Anthropometric evaluations and interviews on food practices will be conducted to the beneficiaries at the beginning and at the end of the program. Anthropometric evaluations will be carried out and psychosocial risks surveys will be applied to the children in charge of the mothers/ caregivers from Comer en Familia. Also, in a sub-sample of the population of mothers/caregivers benefitted from the program, fasting capillary glucose and hemoglobin will be measured at the beginning and at the end of Comer en Familia.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 50 years
* Premenopausal
* Related to the decision of purchase, planning, elaboration-preparation of meals at home.
* Not being pregnant during the period of the study or the six prior months, and planning not to be pregnant at least 3 months after the last visit of the study.
* With a child in her care between the ages of 5 and 13 years and that fulfills the inclusion criteria

Exclusion Criteria:

* Pregnant or breastfeeding
* With a hysterectomy in the past 3 months
* Alcohol consumption \> 14 drinks a week
* Use of vitamin supplements
Impact of Early Peri-operative Use of Polymyxin-B Hemoperfusion in Septic Patients Undergoing Emergent Abdominal Surgery

Septic shock of intra-abdominal origin is likely due to Gram-negative bacteria or mixed pathogens and associated with high levels of endotoxin. The injury to the endothelium results in an increase of endothelial permeability, interstitial edema and release of nitric oxide (NO) that is a very potent vasodilatator. \[6\] Polymyxins obtained from the Gram-positive bacterium Bacillus polymyxa are antibiotics known for their ability to bind LPS in the outer membrane of the Gram-negative bacterial cell wall as well as free endotoxins with high affinity. Polymyxin-B has been shown to block the activation of cells by a wide variety of LPS. Studies converged to show an improvement in the treatment of septic shock by removing circulating endotoxin.Starting Polymyxin-B hemoperfusion during the operative time is to block the initiation of various deleterious biological cascades induced by endotoxemia such as systemic inflammation, disseminated coagulation disorders, and shock, leading to organ dysfunction and death.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years
* Severe sepsis\*or septic shock as define by the ACCCP/SCCM consensus conference, of abdominal origin
* Need for emergent abdominal surgery procedure under general anesthesia with expected duration of ≥ 120 min (in and out patients) for bowel perforation, ileus or peritonitis

Exclusion Criteria:

* Patients younger than 18 years
* Organ transplantation in the last year
* Terminally ill patients: do-not-resuscitate order, perceived to die within 48 hrs of admission
* Known pregnancy or diagnosed by US or Ct-scan (\>14 weeks)
* History of sensitivity to polymyxin-B or to anticoagulant ( heparin)
* Uncontrolled hemorrhage within the last 24h
* Severe granulocytopenia ( leukocyte count of \< 500/µL)
* Severe thrombocytopenia ( platelets count of \< 30'000/µL)
* Need for CPR pre-operatively
Disability, Perceived Social Support and Quality of Life in Multiple Sclerosis

The World Health Organization International Classification of Functioning, Disability and Health has shown that the environment can play a major role in patients' disability, and hence in their quality of life. This study considers social dimensions of quality of life, particularly family as well as social and professional networks.


Eligibility Criteria:
Inclusion Criteria:

* multiples sclerosis, according to McDonald's criteria

Exclusion Criteria:

* lack of French language proficiency
* severe cognitive impairment
* severe aphasia
* substance addiction
* psychiatric troubles (except for treated major depression)
* other severe neurologic or somatic disease
* pregnant or breast feeding patient
Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

This is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (Type II) clavicle fractures.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 16 to 60 years of age
* Completely displaced (no cortical contact), closed fracture of the distal 3rd of the clavicle (Type II) confirmed by radiograph
* Fractures within 28 days post injury
* Provision of informed consent

Exclusion Criteria:

* Pathological fractures
* Non-displaced (cortical contact) distal clavicle fractures
* Open clavicle fractures
* Presence of vascular injury
* Fractures more than 28 days post-injury
* Limited life expectancy due to significant medical co-morbidity
* Medical contraindication to surgery
* Inability to comply with rehabilitation or form completion
* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
Comparison of Postoperative QoR-15 Scores Between Desflurane and Remimazolam in Lumbar Fusion Surgery

The purpose of the study is to compare the quality of recovery (QoR)-15 scores according to the use of maintenance anesthetics in the lumbar fusion surgery. Total intravenous anesthesia (TIVA) have been known to help reducing risks of postoperative nausea/vomiting and malignant hyperthermia. However, it is still not enough to explain which is better between TIVA or inhalation anesthesia. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA with remimazolam. The hypothesis of our study is that total intravenous anesthesia based on remimazolam will demonstrate better quality of recovery compared with the anesthesia based on inhalation using desflurane.


Eligibility Criteria:
Inclusion Criteria:

- Adult patients who aged 20-70 years with ASA-PS 1-3, BMI \<30 undergoing lumbar fusion surgery under general anesthesia

Exclusion Criteria:

* Tolerance or hypersensitivity to benzodiazepine or propofol
* Dependence or addiction to psychotropic drugs or alcohol
* Pregnant women
* subjects who lack the ability to make decisions and susceptible to voluntary participation decisions
Cellular-Mediated Immunity in COVID-19

In order to prevent reinfection, it is needed to detect the cellular-mediated immune response to the Sars-CoV-2 infection. The first goal of this study will be to detect the cellular-mediated immune response in patients affected by COVID-19 (with or without vaccination) and healthy subjects who undergone vaccination program. The second goal of this study will be to identify the genetic and epigenetic biomarkers that influence individual immunological response and clinical evolution to the severe manifestations of the COVID-19.

First goal: Characterization of the immune response using detailed phenotypic evaluation of the adaptive compartment comprising B, T, and NK cells. The Investigators aim is to detect the cellular-mediated immune response in patients affected by COVID-19 and subjects who undergone vaccination program.

The Investigators will recruit three classes of subjects:

1. Patients with previous Sars-CoV-2 infection who did not undergo vaccination;
2. Patients with previous Sars-CoV-2 infection who undergone vaccination;
3. Subjects without previous Sars-CoV-2 infection who undergone vaccination.

Second goal: Evaluation of genetic and epigenetic biomarkers that influence individual immunological response and susceptibility to thromboembolic manifestations in severe COVID-19 hospitalized patients.

The Investigators will recruit:

1. A total of 50 severe COVID-19 patients admitted to the Sub-Intensive Care Unit of A.O.R.N. Ospedali dei Colli, Cotugno Hospital, Naples (Italy) of which N=50 with thromboembolic complications (PE+) and N=50 without thromboembolic complications (PE-);
2. A total of N=50 healthy subjects (never diagnosed with Sars-Cov2 infection) among the volunteer blood donors attending the U.O.C. Divisione di Immunologia Clinica, Immunoematologia, Medicina Trasfusionale e Immunologia dei Trapianti, Dipartimento di Medicina Interna e Specialistica, AOU, "L. Vanvitelli" University of Campania (Naples, Italy)

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Previous diagnosis of COVID-19
* Absence of COVID-19 diagnosis

Exclusion Criteria:

* Age \<18 years
* Inflammatory diseases
In Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance

Ascending aorta aneurysmal disease is common and can be complicated by dissection or rupture. There is substantial variation in individual aneurysm progression: established risk factors for an accelerated aneurysm growth rate include initial size or localization, the presence of aortic valve disease, congenital bicuspid aortic valve or connective tissue disorders.

Although there is an increased lifetime risk when the aortic diameter exceeds 6 cm, predicting aneurysm progression is nearly impossible and dissection and rupture also occur at diameters under 6 cm. The assessment of aortic hemodynamics and the presence of altered flow patterns, as well as distribution and changes in wall shear stress (WSS) and the oscillatory shear index (OSI), using 4D phase contrast cardiovascular magnetic resonance (CMR) may provide further insights in how aneurysms develop and in assessing the risk of dissection. The purpose of this study was to investigate in patients with dilated ascending aorta the flow patterns and vessel wall parameters in order to correlate these hemodynamics factors with changes in aorta size.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Supra-coronary aortic diameter measured by CT-scan or transthoracic/trans-esophageal echocardiography between 40 and 45 mm in case of presence of aortic valve disease, bicuspid aortic valve or connective tissue disease and between 40 and 50 mm in case of absence of aortic valve disease, bicuspid aortic valve disease or connective tissue.
* Informed consent for participation in the study

Exclusion Criteria:

* Contraindication to MRI
* Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent.
An Open-Label Study of Intravenous BAL101553 in Adult Patients With Solid Tumors

First in human, open-label, sequential dose escalation and expansion study of intravenous BAL101553 in adult patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patients with one of the following advanced or recurrent solid tumor types, who failed standard therapy or for whom no effective standard therapy is available:colorectal; gastric or cancers of the gastro-esophageal junction; non-small cell lung cancer; ovarian (or primary peritoneal); pancreatic (including ampullary); triple-negative breast
3. Measurable tumor disease (or non-measurable ovarian cancer that can be followed by CA-125)
4. Life expectancy ≥ 12 weeks
5. Acceptable organ and marrow function at baseline (protocol defined laboratory parameters)
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
7. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Patients who have received chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to starting study drug or who have not recovered from side effects of prior therapies
2. Symptomatic brain metastases (including leptomeningeal disease) indicative of active disease
3. Peripheral neuropathy ≥ CTCAE v4 grade 2
4. Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or limit compliance with study requirements
5. Women who are pregnant or breast-feeding. Men or women of reproductive potential who are not willing to apply effective birth control
6. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg observed as part of the screening examination.
7. Patients treated with a calcium channel blocker or who require combination of more than 2 antihypertensives to control blood pressure.
8. Other protocol-defined exclusion criteria may apply.
The Supplementary Effects of the Extract of Agaricus Blazei Murril on Type II Diabetes Mellitus (DM)

The purpose of this study is to examine whether the extract of the Agaricus blazei Murill mushroom is effective in the supplementary treatment of type II DM patients.

The researchers have the animal model that the extract of the Agaricus blazei Murill mushroom is effective in the treatment of type II DM mice conducted on 2002. The dose effects were also found. The researchers conducted the pilot study also showing the same effects in 2003. So the researchers designed this trial. The elixir of the Agaricus blazei Murill mushroom is popular in Taiwan for chronic diseases, such as type II DM.

Eligibility Criteria:
Inclusion Criteria:

* Type II DM
* Age 20-75 years old
* Treat with Gliclazide and Metformin
* Signed informed consent

Exclusion Criteria:

* GOT/GPT \>80/80
* Creatinine \> 2.0
* Lactating or pregnant women
HSK7653 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

The purpose of this study is to assess the efficacy of HSK7653 (as monotherapy) compared with placebo after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with Type 2 diabetes who are insufficient glycaemic control with diet and exercise.

The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). During the double-blind period, participants will receive 10 mg or 25 mg dose of HSK7653 and matching placebo, or placebo only. During the open-label period, all participants will receive 25 mg dose of HSK7653.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 75 years, Male and female patients;
* Type 2 diabetes mellitus;
* Control the blood glucose level only with diet and exercise in last 8 weeks;
* Did not receive regular long-term medication of oral hypoglycemic drugs or insulin within 1 year prior to informed consent;
* HbA1c in the range of ≥7.5 to ≤11.0% at screening;
* FPG \< 15 mmol/L at screening;
* BMI (Body Mass Index) in the range of ≥ 18.0 kg/m² to ≤ 35.0 kg/m² at screening.

Exclusion Criteria:

* Diabetic ketoacidosis, hyperglycemia hypertonic state, serious complications of diabetes, myocardial infarction, stroke within 6 months prior to informed consent;
* History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;
* Current hemoglobinopathy, uncontrolled hypertension, serious nephropathy or hepatopathy prior to informed consent;
* Serious gastrointestinal disease within 2 weeks prior to informed consent;
* Serious infection, trauma and surgery within 3 months prior to informed consent;
* History of treatment with Dipeptidyl-Peptidase 4 (DPP-4) inhibitor, Glucose-dependent insulinotropic polypeptide (GIP) or Glucagon-like peptide-1 (GLP-1) receptor agonist;
* Treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent;
* Hemoglobin (HGB) \< 10.0 g/dL(100 g/L);
* Alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent;
* Active infectious diseases;
* Participation in another trial with an investigational drug or instrument within 3 months prior to informed consent;
* Women who are nursing or pregnant, or subjects with birth plans;
* Contraindication for metformin;
* Other protocol-defined inclusion/exclusion criteria.
Does Repetitive Electroconvulsive Therapies Affect Propofol Induction Dose ?

Electroconvulsive therapy has been used for many years for different types of physiatric diseases. General anesthesia is used during the procedure. Different anesthesiologists use different regimens. The duration of seizure is important in this procedure. The investigators evaluated the relationship between the dose of propofol and the number of electroconvulsive therapy and duration of the seizure.


Eligibility Criteria:
Inclusion Criteria:

* Patients required electroconvulsive therapy for the physiatric disease

Exclusion Criteria:

* Patients refusal
A Study for Patients With Schizophrenia

The purpose of this study is to test the hypothesis that 1 or more dose levels of LY2140023 given orally to patients with schizophrenia twice daily for 4 weeks will have significantly greater effect than placebo.


Eligibility Criteria:
Some Inclusion Criteria:

* Patients must have a diagnosis of Schizophrenia as defined in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (Disorganized, 295.10; Catatonic, 295.20; Paranoid, 295.30; Residual, 295.60; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV (SCID).
* Patients must meet the following psychopathologic severity criteria at Visit 1: Brief Psychiatric Rating Scale (BPRS) total score, extracted from the Positive and Negative Syndrome Scale (PANSS), of at least 45 (18-item version, in which 1 indicates "absent" and 7 indicates "severe"). In addition, item scores of at least 4 (moderate) will be required on 2 of the following BPRS items: conceptual disorganization, suspiciousness, hallucinatory behavior, and/or unusual thought content.
* Patients must receive a rating of 4 (moderately ill) or greater on the Clinical Global Impression-Severity (CGI-S) scale at Visit 1.
* Patients in whom, in the opinion of the investigator, a switch to another antipsychotic medication or initiation of an antipsychotic medication is acutely indicated.

Some Exclusion Criteria:

* Patients in whom treatment with olanzapine or placebo is relatively or absolutely clinically contraindicated.
* Patients who have a history of inadequate response to an adequate treatment trial with olanzapine, in the opinion of the investigator.
* Patients who have received treatment with olanzapine within 6 weeks prior to Visit 1.
* Patients who have received treatment with clozapine at doses greater than 200 mg daily within 12 months prior to Visit 1, or who have received any clozapine at all during the month before Visit 1.
* Patients who have a history of an inadequate response, in the opinion of the investigator, to 2 or more adequate antipsychotic medication trials of at least 8 weeks duration in the past 12 months prior to Visit 1.
* Patients with acute, serious, or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (hemoglobin A1c (HbA1c) 8%), severe hypertriglyceridemia (fasting triglycerides 5.6 mmol/L, recent cerebrovascular accidents, serious acute systemic infection or immunologic disease, unstable cardiovascular disorders (including ischemic heart disease), malnutrition, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases.
PSMA Specific [68Ga]-P137 Peptide Probe for PET Imaging in Prostate Cancer

To study the radioactive uptake of \[68Ga\]P137 in the lesion sites of PCa patients and evaluate the ability of \[68Ga\]P137 to detect PSMA overexpression in PCa patients (especially those with recurrent or advanced PCa).

Prostate cancer is the most common malignancy of the male reproductive system.Prostate specific membrane antigen is a highly specific prostatic epithelial cell membrane antigen, which is highly expressed in solid tumors such as prostate cancer. More than 90% of prostate cancer cells express PSMA, so PSMA can be used as an important imaging target for prostate cancer.Positron emission tomography has the advantages of non-invasive, high resolution and high sensitivity, etc. The PET tracer based on PSMA radiographic label is developing rapidly, which is of great significance for the early diagnosis, prognosis and treatment of prostate cancer.Used for radionuclide 68Ga has a half-life of PET imaging (T1/2 = 68 min) is appropriate, prepared from 68Ge-68Ga generator, relatively low cost, coordination marking method is simple, easy to realize automatic synthesis technology and advantages of medicine preparation, so 68Ga- labeled PSMA targeted molecular probe in prostate cancer has been widely applied in the diagnosis of disease.

\[68Ga\]P137 is a novel PSMA targeted molecular probe labeled with 68Ga. DOTA is used as a bifunctional linker to coordinate with 68Ga3+. The labeling method is simple, the biological stability is high, the tumor site has obvious radioactive enrichment, and the imaging effect is superior.This project provides research on \[68Ga\]P137 PET/CT imaging for patients with suspected PCa, and provides basis for early diagnosis of PCa, formulation of treatment plan and efficacy evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Men over 18 years of age need to undergo \[68Ga\]P137 PET/CT examination for suspected prostate cancer.
* The patients can fully understand and voluntarily participate in this experiment, and sign the informed consent.

Exclusion Criteria:

* Significant hepatic or renal dysfunction;
* Patients with malignant tumors other than prostate cancer within 2 years;
* Ready to pregnant;
* The patient can not tolerate all clinical tests.