cyrilzakka/clinical-trials huggingface dataset:
Preventive Effect of Probiotics in GDM

Gut microbiota is instrumental in the microbial and metabolic network of pregnant women, and is potentially related with gestational diabetes. Perinatal probiotic intervention contributes to improved glucose regulation during pregnancy. Our randomized, double-centered, placebo-controlled study is planned to recruit 334 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly probiotic powder per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about neonatal weight will be registered.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who meet the high-risk indicators for GDM and agree to participate in this study.

  1. included between 12-16 gestational weeks
  2. A woman was considered high risk when her pre-pregnancy BMI ≥ 24 kg/m\^2, having family history of diabetes (type 1 or 2), GDM or PCOS (polycystic ovary syndrome) history, history of delivering macrosomia or stillbirth, or glucose in urine (+)

Exclusion Criteria:

1. Taking probiotics or prebiotics within the past month
2. Have a history of allergies to the drug components or similar drugs in this study
3. Having long-term smoking or drinking habits
4. Type 1 or type 2 diabetes patients with definite diagnosis before pregnancy
5. Diseases in other important organs such as heart, liver, and kidney
6. with clear digestive system diseases
7. Multiple pregnancy
8. with mental or cognitive impairments who are unable to complete this study
Glucose Reduction by Early Acarbose Treatment in Basal Insulin

The purpose of this study is to evaluate the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetic patients whose blood glucose levels were inadequately controlled with insulin glargine alone or in combination with metformin.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-79 years
* Type 2 diabetes inadequately controlled with insulin glargine alone or in combination with metformin

  * Diagnosed of type 2 diabetes for at least 6 months prior to screening
  * Treated with tolerable, stable dose of insulin glargine and/or metformin for at least 3 months prior to screening
  * HbA1C \> 7.0 and \</= 10.0% at screening

Exclusion Criteria:

* Type 1 diabetes patients
* Myocardial infarction, unstable angina or coronary artery bypass surgery within previous 6 months
* Clinical evidence of active liver disease, or serum ALT or AST 3 times the upper limit of the normal (ULN) range
* Serum creatinine \>/= 1.5 mg/dl for males, \>/= 1.4 mg/dl for females
* Active proliferative diabetic retinopathy
* Any other anti-diabetic medications except insulin glargine and metformin within 4 weeks prior to study entry
* Gastrointestinal diseases that are likely to be associated with abnormal intestinal motility or altered absorption of nutrients (e.g. gastroparesis, malabsorption syndrome, chronic diarrhea states, enteropathies, inflammatory bowel disease, partial intestinal obstruction, and large hernias)
* Galactose intolerance
* Pregnancy
* Delivery, abortion, or lactation within less than three cycles before the start of treatment
* No use of contraceptive in childbearing aged. Women of childbearing potential must agree to use adequate contraception (barrier method of birth control) since signing of the informed consent form until at least 30 days after the last study drug administration.
* Hypersensitivity to the active substances or any of gradient of the study drug ingredients
* Treatment with any medication including corticosteroid or herb medication that can affect blood glucose level in the 3 months prior to study entry
* Any disease or condition that in the opinion of the investigator may interfere with completion of the study
Inflammatory Markers and Level of Cortical Hyperactivity

Alzheimer's disease (AD) is a progressive and fatal neurodegenerative disease that is manifested by severe cognitive impairment mainly from late life (\>65 years). Clinical studies have shown that both systemic inflammation and cortical and hippocampal hyperactivity are features present in patients during the early stages of the disease. In this project we will seek to relate the levels of the proinflammatory cytokines interleukin-1beta, interleukin-6 and tumor necrosis factor-alpha with the level of cortical hyperactivity evaluated with the electroencephalographic changes induced by the GABAergic anesthetic propofol in older adults undergoing elective surgery.

Alzheimer's disease (AD) is a progressive and fatal neurodegenerative disease that is manifested by severe cognitive impairment mainly from late life (\>65 years). It is now known that markers of damage begin decades before symptoms can be detected, at the stage called preclinical early AD, which progresses inexorably to mild cognitive impairment and ends in severe Alzheimer's dementia. Clinical studies have shown that both systemic inflammation and cortical and hippocampal hyperactivity are features present in patients during the early stages of the disease, however, they have not been directly related in a clinical context. In this project we will seek to relate the levels of the proinflammatory cytokines IL-1beta, IL-6 and TNF-alpha with the level of cortical hyperactivity evaluated with the electroencephalographic changes induced by the GABAergic anesthetic propofol in older adults undergoing elective surgery. The main goal of this project is to determine the levels of inflammatory markers and cortical hyperactivity in older adults. Methodology: the project is an exploratory observational study of a prospective cohort of patients \> 60 years of age who will undergo elective surgery under general anesthesia. In the preoperative period, peripheral venous blood samples will be obtained and stored at -80 ° C and then analyzed by the SIMOA® analyzer, fully automated and digital equipment for performing immunoassays, based on SIMOA® technology, which provide an ultrasensitive signal and / or measurement up to 1000 times greater than conventional immunoassays (in the femtomolar range) of proteins. On the other hand, EEG signal at 128 Hz and other variables from BIS® monitor will be recorded to determine the level of cortical hyperactivity.

Eligibility Criteria:
Inclusion Criteria:

1. Adults over 60 years of age undergoing elective surgery
2. Able to understand and sign an informed consent form

Exclusion Criteria:

1. Diagnosis of other neurological pathologies
2. No active acute or chronic decompensated diseases
3. No severe psychiatric illnesses
4. Propofol allergy
Closure of Patent Ductus Arteriosus With Indomethacin or Ibuprofen in Extreme Low Birth Weight Infants

Pharmacological closure of ductus arteriosus with prostaglandin (PG) inhibitors has been used for years. Previous studies indicated that ibuprofen has similar effect on ductal closure as indomethacin but has less adverse effects on renal function, cerebral blood flow and mesenteric blood flow.1-7 There are, however, very few studies being done specifically on extremely low birth weight (ELBW) infant \< 1000 g. This group of infants has immature kidney and often has poor response to PG inhibitors and has high mortality and morbidity. We hypothesized that, in ELBW infants, the ductal and renal response to PG inhibitors may be different between indomethacin and ibuprofen.

The aims of this study are to compare the efficacy, the side effects and the renal prostaglandin (PG) excretion between indomethacin and ibuprofen in extremely low birth weight (ELBW) infants. We enrolled one hundred and ten ELBW infants who had clinically significant and echo-evidence patent ductus arteriosus were assigned into 2 groups, 56 received indomethacin (0.2 mg/kg, 0.1 mg/kg and 0.1 mg/kg in 24 hours interval) and 54 received ibuprofen (10 mg/kg, 5mg/kg and 5 mg/kg in 24 hours interval). Serum electrolytes, creatinine, renal function (urine output, glomerular filtration rate (GFR), fractional excretion of sodium and potassium, osmolar clearance and free water clearance), urinary PG excretion, pulmonary outcome and mortality were all evaluated.

Eligibility Criteria:
Inclusion Criteria:

* The selection criteria were: (1) preterm infants with birth weight \<1000 g; 2) radiographic diagnosis of respiratory distress syndrome (RDS); (3) requirement of mechanical ventilation and (4) echocardiographic and clinical evidence of significant patent ductus arteriosus (PDA).

Exclusion Criteria:

* Exclusion criteria included: (1) evidence of infection or sepsis; 2) lethal congenital anomalies; (3) oliguria (\< 1 ml/kg/h) and/or serum creatinine \> 2.0 mg/dl and (4) low platelet count (\< 50,000/mm3) or bleeding tendency.
Continued Safety Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in the FB401-01 Study

The purpose of this study is to evaluate the continued safety and tolerability of FB-401 in subjects 2 years of age or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for up to 48 additional weeks and subjects will be evaluated for safety.


Eligibility Criteria:
Inclusion Criteria:

* Participated in Protocol FB401-01, completed through Week 20 visit and able to directly enroll into this (FB401-02) study
* Refrain from use of all other atopic dermatitis treatments, unless given permission by medical monitor

Exclusion Criteria:

* Subject experienced a serious adverse event or severe adverse event attributable to study drug in Protocol FB401-01
* Severe concomitant illness that, in the Investigator's opinion, would adversely affect subject participation in the study, whether medical or psychological
* Pregnant (or planning to become pregnant during the period of the study) or lactating females
PEA in Functional Dyspepsia

The goal of this placebo controlled randomized double blind interventional study is to assess the effect of palmitoylethanolamide supplementation in patients with functional dyspepsia The main questions it aims to answer are:

* The efficacy of PEA on functional dyspepsia symptoms measured using the LPDS questionnaire
* The effect of PEA on duodenal mucosal permeability.

Participants will receive an 8-week during treatment with PEA 3x400 mg per day or placebo 3 times per day.


Eligibility Criteria:
Inclusion Criteria:

* Patients with functional dyspepsia as diagnosed by the Rome IV criteria.
* Subjects must provide witnessed written informed consent prior to any study procedures being performed.
* Subjects aged 18-70 years old.
* Male or female subjects.
* Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.
* Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.

Exclusion Criteria:

* Presence of a history of gastrointestinal surgery other than appendectomy and cholecystectomy.
* Organic gastro-intestinal disease
* Major psychiatric disorder such as major depression
* Presence of coeliac disease, lupus, scleroderma and other systemic auto-immune disease.
* Patients with eosinophilic esophagitis
* Presence of diabetes mellitus
* Active H. Pylori infection or \< 6 months after eradication
* Predominant IBS (based on the Rome IV questionnaire)
* Predominant GERD (based on the Rome IV questionnaire)
* Patients taking prohibited medication
* Females who are pregnant or lactating
* Patients not capable to understand or be compliant with the study.
Arizona Cancer Center Biospecimen Repository

RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to test in the laboratory may help the study of cancer in the future.

PURPOSE: This research study is collecting and storing tumor, tissue, and blood samples from patients with pancreatic cancer.

OBJECTIVES:

* Provide cancer investigators access to a wide variety of tissues and biospecimens for translational studies in cancer.
* Collect and preserve tissue from the primary organ site (uninvolved and involved with cancer), from the metastases, from patient blood (serum and lymphocytes), and from patient urine.
* Provide quality-controlled storage and management of the specimen bank.
* Collect relevant clinical and pathologic information with appropriate privacy protection.
* Contribute to the development of a comprehensive database annotated with relevant clinical data, pathology, and research findings.

OUTLINE: This is a multicenter study.

Tumor samples, lymph node samples, and normal pancreas tissue samples are collected. Blood samples are also collected prior to surgery, six months after the initial blood draw and tissue sample collection, and every six months thereafter for two years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patient who is seen at the Arizona Cancer Center or University Medical Center and will undergo any surgery or procedure for cancer

PATIENT CHARACTERISTICS:

* NA

PRIOR CONCURRENT THERAPY:

* NA

As this is a biospecimen repository, participation is open to all cancer patients being treated at the Arizona Cancer Center or University Medical Center by investigators on this protocol.
Optimal Standard Treatment Selection for Solid Tumor Patients by Biologically-informed Multi-agent System

This study is an exploratory cohort study conducted under real-world conditions, aiming to evaluate the feasibility of an artificial intelligence (AI)-guided standard treatment selection model for advanced solid tumors, as well as its superiority compared to clinician-selected treatment plans. A multi-agent system based on multimodal AI models will rank the priority of standard treatment options based on the personalized information of the patients, including including demographics, clinical information, and multi-omics data. The final treatment plan will be jointly selected by the patient and the clinician from the AI-recommended options, thereby delivering a personalized treatment.

This study is an exploratory cohort study conducted under real-world conditions, aiming to evaluate the feasibility of an artificial intelligence (AI)-guided standard treatment selection model for advanced solid tumors, as well as its superiority compared to clinician-selected treatment plans. The study will prospectively collect patient data of multiple dimensions, including demographics, clinical information (pathological classification, tumor staging, imaging findings, previous treatment regimens and their effectiveness, performance status scores), and multi-omics data (DNA gene panel testing, whole-exome sequencing, transcriptome sequencing, etc.). A multi-agent system based on multimodal AI models will rank the priority of standard treatment options based on the personalized information of the patients. The final treatment plan will be jointly selected by the patient and the clinician from the AI-recommended options, thereby delivering a personalized treatment.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate in the clinical study, fully understand and be informed about the study, sign the informed consent form, and be willing and able to comply with and complete all trial procedures.
* Aged ≥18 years, no gender restrictions.
* Patients with advanced or metastatic malignant tumors confirmed by histology or cytology.
* Able to provide tumor tissue and peripheral blood samples for multi-omics testing, or able to provide qualified whole-exome sequencing and transcriptomics data.

Exclusion Criteria:

* As assessed by the investigator, no standard treatment is available, or the patient is unsuitable for guideline-recommended anti-tumor therapies.
* Other conditions deemed unsuitable for participation in this study by the investigator.
Novel Subtypes of Polycystic Ovary Syndrome

To classify subtypes of Polycystic Ovary Syndrome (PCOS) using machine-learning algorithms, and compare the reproductive and metabolic characteristics and IVF outcomes across these identified subtypes.

In this study, we've developed a machine-learning model to classify PCOS patients into four subtypes based on nine clinical characteristics.

The goal of this observational study is to:

* Learn about different PCOS subtypes using our classification model.
* Compare the reproductive and metabolic features of these subtypes.
* Assess the outcomes of IVF among different PCOS subtypes.
* Prospective 6.5-year follow-up data will be collected.

Participants will:

* Undergo a telephone interview to gather details on:

  1. Current physical stats like height and weight.
  2. Reproductive history, including pregnancies and childbirths in recent years.
  3. Details about any IVF treatments.
  4. Current status of conditions such as PCOS, Type 2 Diabetes, hypertension, and dyslipidemia.
* Be invited for a physical examination that includes:

  1. Measurements such as height, weight, blood pressure, and body circumferences.
  2. Laboratory tests for endocrine and metabolic conditions.
  3. Ultrasound scans of the ovaries and liver.

Eligibility Criteria:
Inclusion Criteria:

* PCOS patients diagnosed using the Rotterdam criteria, which requires the presence of at least two of the following:

  1. Menstrual Irregularities: A menstrual cycle length of fewer than 21 days or more than 35 days, and/or fewer than eight cycles per year.
  2. Hyperandrogenism: Defined either by an elevated total testosterone level (as per local laboratory criteria) or by a modified Ferriman-Gallwey (mFG) score of 5 or higher.
  3. Polycystic Ovaries on Ultrasound: Presence of 12 or more follicles measuring 2-9 mm in diameter in each ovary and/or an ovarian volume exceeding 10 mL.

Exclusion Criteria:

Patients with congenital adrenal hyperplasias, androgen-secreting tumours, or Cushing's syndrome) will be excluded.
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)

This prospective, multi-center, observational study will assess the safety and efficacy of Avastin (bevacizumab) in daily practice in patients with metastatic colorectal cancer who have received no previous treatment for advanced disease and are receiving Avastin in combination with a standard of care first-line chemotherapy regimen. Data will be collected for 1.5 years or until death.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal cancer with no previous systemic treatment for advanced disease
* Receiving Avastin in combination with a first-line standard of care chemotherapy regimen
* Avastin initiated at the same time as first-line chemotherapy regimen

Exclusion Criteria:

* Investigational, non-standard of care first-line chemotherapy regimen for treatment of metastatic colorectal cancer
* Contraindication to Avastin
Phase I Clinical Study of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer

The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry of HRS-9815 for PET/CT imaging in adult patients with prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing;
2. Male, age ≥18 years;
3. ECOG score 0 - 1;
4. Histologically confirmed adenocarcinoma of the prostate;

Exclusion Criteria:

1. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc. Note: Subjects with bladder outflow obstruction or urinary incontinence that can be controlled by the best available standard of care (including pads, drainage, etc.) are eligible to participate in the study.
2. Active syphilis infection.
3. Known allergy, hypersensitivity, or contraindication to the trial product or any component of its formulation.。
4. Active in other clinical studies or less than 4 weeks after the last dose in the previous clinical study at the time of the first dose.
Microplastica Pollution Awareness Level of Students

This study aims to raise awareness among individuals about plastic and microplastica pollution, reduce plastic consumption, reduce the amount of plastic waste that grows cumulatively every year, and contribute to the development of a livable environment.

The aim of this research is to investigate the effect of environmental health education given at the 9th-grade level on the microplastica pollution awareness level of students.

This pretest-posttest experimental study with a randomized control group was conducted between 2022 and 2023 in three high schools in a province in eastern Turkey. The sample of the study consisted of 90 ninth-grade students (experimental group: 45, control group: 45), and the sample magnitude was determined by power analysis. Tools such as the "Personal Information Form" and "Microplastica Pollution Awareness Scale (MPAS)" were used to collect data. Training was given to the experimental group as a nursing intervention in a total of 4 sessions at 15-day intervals. No intervention was applied to the individuals in the control group. In the data evaluation process, percentage distribution, arithmetic mean, standard deviation, chi-square test, correlation and regression analyses were used.

While no significant difference was observed in the MPAS total score in the control group according to the pre-test and post-test mean scores, a significant difference was observed in the MPAS total score in the experimental group (p≤0.05). When the posttest mean scores of the experimental and control groups were examined, it was observed that the posttest mean scores of the experimental group were higher than the posttest mean scores of the control group and there was a statistically significant difference (p≤0.05).

It was observed that the microplastica pollution awareness level of the experimental group students who received environmental health training increased significantly.

Eligibility Criteria:
Inclusion Criteria:

* age group of 13-15 years,
* 9th-grade students,
* without any intellectual disability,
* with parental consent.

Exclusion Criteria:

* Previous or current participation in an MPAS training,
* Inability to obtain parental consent.