cyrilzakka/clinical-trials huggingface dataset:
Flavonoids and Cardiovascular Disease

To determine the association between flavonoids intake and the prevention of incident cardiovascular disease (CVD).

BACKGROUND:

Basic science, clinical observation, and epidemiologic studies have all contributed to an emerging body of evidence on the potential role of flavonoids, a group of polyphenolic compounds with antioxidant properties, in the prevention of cardiovascular disease. However, the few existing studies on flavonoids or its food sources have provided inconsistent results, usually focusing on the primary prevention of coronary heart disease mortality. The study used the small grant mechanism (R03) to analyze previously collected data.

DESIGN NARRATIVE:

The investigators examined whether flavonoid intake was associated with the risk of incident CVD, and whether specific food sources of flavonoids--including tea, onions, apples, red wine, and other foods--were associated with the risk of incident CVD. The investigators processed and analyzed previously collected data of 39,876 middle-aged and older women free of CVD; the Women's Antioxidant Cardiovascular Study (WACS), a prospective study of 8,171 middle-aged and older women with pre-existing CVD or more than three coronary risk factors; the Normative Aging Study (NAS), a prospective study of 2,280 middle-aged and older men; and the Boston Area Health Study (BAHS), a case-control study of first nonfatal myocardial infarction in men and women aged less than 76 years. Using data from semiquantitative food frequency questionnaires administered in each study, the investigators determined individual intake of flavonoids and its food sources. Unlike previous studies, they examined flavonoids in relation to both the primary and secondary prevention of incident cardiovascular disease (CVD), consisting of confirmed cases of nonfatal myocardial infarction (Ml), nonfatal stroke, revascularization procedures, and CVD death.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Optimizing Counceling on Feeding Options of Babies From Mothers Living With HIV

Semi structured interviews will be performed to determine attitudes and experiences of people living with HIV and health care providers on counseling on feeding options of babies from mothers living with HIV in order to optimize counseling in the future


Eligibility Criteria:
Inclusion Criteria:

* Health care provider involved in care for people living with HIV in Duth HIV treatment facility or
* Person living with HIV + age 18-45 + prior pregnancy/desire to have children

Exclusion Criteria:

* Insufficient command of Dutch or English language (oral)
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by observation for the treatment of participants with IR-NMIBC.

Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs observation after TURBT (Arm B).

Participants in Arm A will receive an induction course and then quarterly maintenance courses of cretostimogene through Month 13, if there is no disease recurrence.

Disease status will be assessed using urine cytology, complete bladder visualization (e.g., cystoscopy), and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence.

Participants in Arm B who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene as per the treatment schedule in Arm A.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization:

  1. Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor
  2. Solitary LG Ta \>3 cm tumor
  3. Multifocal LG Ta tumors
  4. Primary and solitary HG Ta ≤3 cm tumor
  5. LG T1 tumor
* All visible disease removed by TURBT within 12 weeks of study randomization
* Acceptable baseline organ function

Exclusion Criteria:

* High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta\>3cm tumor(s), CIS)
* Low-Risk NMIBC (e.g., solitary LG Ta ≤3 cm tumor)
* Disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization
* Muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer
* Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Ad-interferon or Adstiladrin)
Vitamin K2 for Reduction the Calcium at Carotid Bifurcation in Patients With Subcritical Lesions

Clinical study single center, prospective, randomized, controlled (vs. no supplement), open-label, blinded assessor (the doctor who will perform the Doppler ultrasound at 6 and 12 months will not know the treatment given to the patient, because the diagnostic test in question is considered operator-dependent), a "parallel group", which aims is evaluate the reduction in the level of calcium in the carotid artery and the carotid atherosclerotic plaques, on a sample of 60 subjects presenting subcritical calcified lesions of the carotid bifurcation with a range of 40-60%.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Ability to provide written informed consent
3. subjects with calcified lesions subcritical from the carotid bifurcation. with a range of 40-60% calculated method with ECTS (European Carotid Surgery Trial)

Exclusion Criteria:

1. Patients with reduced life expectancy or age\> 80 years,
2. Patients already subjected to other clinical trial in the previous three months,
3. Patients with hypersensitivity or with known allergies to acetylsalicylic acid, patients with pre-existing mastocytosis, a history of asthma induced by salicylates, duodenal ulcer, bleeding diathesis, severe hepatic insufficiency, severe heart failure, concomitant treatment with methotrexate, last trimester of pregnancy.
4. Patients with known hypersensitivity to vitamin K2 and vitamin D, people with hemolytic diseases, concomitant anticoagulant therapy, people with cancer, MAV (arteriovenous malformations) and / or cerebral aneurysms, hypercalcemia, nephrolithiasis and renal failure.
5. Uncooperative patients , or allergies related to the substance under study or with any contra-indicated in the data sheet / Summary of Product Characteristics (SPC) of the substances in the studio.
Low Carb Diets & Exercise for Cardiovascular Disease (CVD) Reduction

The purposes of this study are:

To investigate the effects of a 6 month low carbohydrate diet in obese men on markers of heart health including blood fats, blood clotting factors, inflammatory markers and levels of body fat.

To investigate the added effect on heart health that regular moderate exercise may have when combined with a low carbohydrate diet in obese men.


Eligibility Criteria:
Inclusion Criteria:

* male
* 21-65 years
* body mass index (BMI) 27-40kg/m2
* not currently losing weight
* physically able to exercise at moderate intensity
Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Cannabis Use and Cognitive Outcomes in Schizophrenia

The high prevalence of cannabis and other substance use disorders are a major barrier to recovery in people with schizophrenia. Moreover, schizophrenia patients have significant deficits in cognitive function, which may be exacerbated by cannabis use. Complicating these problems is the lack of evidence-based treatments for co-morbid cannabis use disorders (CUDs) in schizophrenia; there are no established pharmacotherapies. Therefore, this study is investigating the effects of high-frequency (20Hz) repetitive transcranial magnetic stimulation (rTMS) on cannabis use disorder and cognitive function in patients with co-morbid schizophrenia/schizoaffective disorder. The proposed study would be the first randomized, double-blind, sham controlled trial of rTMS in patients with schizophrenia and co-morbid CUD. A total of N=40 schizophrenia smokers with co-morbid cannabis use disorder will be assigned to either active rTMS (N=20) or sham rTMS (N=20) as a treatment regimen of 5X/week treatment for four consecutive weeks. All participants will receive weekly behavioral therapy for 4 weeks. The investigators predict that active rTMS will be well-tolerated and superior to sham rTMS for the treatment of CUD in schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

1. Male (80%) or Female (20%);
2. Age 18-55;
3. Meet the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for Schizophrenia (SZ) or schizoaffective disorder and cannabis use disorder with physiological dependence;
4. Full scale intelligence quotient (IQ) ≥ 80 determined through the Wechsler Test of Adult Reading (WTAR);
5. Non-smokers OR cigarette smokers as confirmed with Fragerstrom Test for Nicotine Dependence (FTND) score of 5 or higher, self reported smoking of at lest 5 cigarettes per day (measured by the Timeline Follow Back), and verified by a Smokerlyzer test, cut-off as 10 ppm.

Exclusion Criteria:

1. DSM-5 diagnoses of alcohol, substance or polyuse substance use disorder in the past 6 months (other than cannabis/caffeine or nicotine);
2. Currently active suicidal ideation or self-harm (suicidal or non-suicidal) as assessed by the Structured Clinical Interview for DSM-5 (SCID-5);
3. Head injury resulting in loss of consciousness (\>5 minutes) and hospitalization;
4. Major neurological or medical illness including seizure disorder or syncope;
5. Metallic implants;
6. History of rTMS treatment;
7. Pregnancy.
Comparative Analysis of Incidence of Newly Developed Postoperative Low Back Pain with Field Block Versus Without Field-block Before Spinal Anaesthesia for Patients Undergoing Caesarean Sections

The study aimed to evaluate the effectiveness of field block in preventing postoperative low back pain (PDPB) in patients undergoing Cesarean Sections.

The purpose of this study was to evaluate the effectiveness of field block with lidocaine 2% (5 ml) administered with a 24G hypodermic needle before spinal anesthesia for patients undergoing LSCS, in preventing the development of postoperative low back pain (PDPB). The study aimed to determine if using a field block would decrease the incidence of PDPB compared to patients who received only spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria: All patients undergoing LSCS under spinal anesthesia, ASA Grade 2 and Grade 2E and willing to participate in the trial

Exclusion Criteria: Spine pathology/instability and coagulopathy, ASA Grade 3 and above, Pre-exiting low back pain, Morbid Obesity (BMI \&gt; 35), Patients needing more than 1 attempt for administration of spinal anaesthesia, Patients utilizing labour analgesia, Local infection or inflammation at the site of spinal anesthesia/field block, Unwilling to participate

-
COMMETS- Combination MCI Metabolic Syndrome

The investigators propose a proof of concept RCT (randomized clinical trial), testing the efficacy of intranasal insulin (INI) with semaglutide, a combination therapy with strong biological plausibility to benefit impaired cognition through vascular mechanisms, in older adults with MetS (metabolic syndrome) and MCI (Mild Cognitive Impairment), who are enriched for cerebrovascular disease and at high dementia risk. The study will focus on cognitive and biological outcomes, allowing identification of relevant mechanisms.

The Specific Aims of the study are:

Aim 1. To examine the ease and precision of use of the intranasal device and once daily semaglutide pill.

Aim 2. To examine the adherence to the two types of treatment.

Aim 3. To examine the safety profile of the combination of intranasal insulin with semaglutide. The safety profile of each has been published broadly, but the safety of their combination has not been examined.

Aim 4. Although the primary goal of the pilot study is proof of concept essential to design a large combination therapy RCT, The investigators will compare the combination of intranasal insulin and semaglutide with the other three groups on a) cognition, b) cerebral blood flow (via ASL MRI), c) glucose uptake (via FDG PET), ADRD(Alzheimer's disease and related disorders)-related blood biomarkers (Aβ42/Aβ40 ratio, pTau181 and 231, NfL and GFAP), and expression of insulin signaling genes from brain derived exosomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MCI (based on a MOCA \<27 and a clinical dementia rating scale \[CDR\] score of 0.5 representing questionable dementia).
* Diagnosis of MetS -requiring a) abdominal obesity (waist circumference \>102cm for men and \>88cm for women), and b) glucose intolerance (fasting glucose\>110 mg/dL) and at least one of the following-c) dyslipidemia (high triglycerides \[\>150 mg/dL\] and low HDL \[\<40mg/dL for men and \<50 mg/dL for women\]), or d) elevated blood pressure (\>130/\>85 mmHg).
* Fluent in Hebrew
* The study requires an active study partner

Exclusion Criteria:

* Diabetes (of any type)
* Taking medications that may affect glucose metabolism (including a GLP-1RA).
* Diagnosis of dementia and its subtypes, conditions that may directly affect cognition,
* short life expectancy or a medical condition that precludes consistent participation in the study,
* contraindications to either insulin or Semaglutide.
* Medications that may affect glucose metabolism such as corticosteroids.
Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients

Chemotherapy as one of the basic modalities of oncology treatment often leaves permanent implications and among the most common is infertility as a result of irreversible gonadal damage. This project sets the primary target to verify the protective effect GnRH analogues administration to protect ovarian tissue during three different regimens of chemotherapy in patients with Hodgkin disease (HD) in reproductive age.

During the first two years of the project duration the curative anti-tumorous combined treatment in fertile patients with Hodgkin disease diagnosis will be carried out. Patients are to be divided into three groups according to the clinical stage of the disease and treated with the three types of the chemotherapeutic regimens comparable with toxicity. Patients will receive GnRH analogues during the chemotherapy for the gonadal protection by the mechanism of foliculogenesis inhibition in pre-pubertal stage. At the end of successful treatment according to stated criteria the ovarian function of every patient will be repeatedly evaluated in relation with toxicity of chemotherapy used. These ovarian function results will be compared with control group of patients without gonadal protection, which reproductive functions will be evaluated according the same method.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Hodgkin lymphoma
* FSH and LH levels in peripheral blood below 15 IU/l
* fertile age from 18 to 35 years
* female
* presence of both ovaries

Exclusion Criteria:

* ovarian tumours or cysts over 40 mm in diameter
Investigation of the Glycemic Index of Ethiopian Honey

The purpose of this study is to determine which of the Ethiopian honeys slowly/rapidly raise the blood glucose level.

Addis Ababa University, College of Natural Sciences, Research Institutional Review Board (IRB) approved this study. Written consent forms were obtained from all 14 volunteers (7 females and 7 males). The subjects were randomly recruited from twenty eight 3rd year Food Science and Postharvest Technology students. People volunteering to participate in the study were excluded if they are: overweight, dieting, smoking, a family history of diabetes, pregnant, metabolic disorders, suffering from any illness or food allergy and regularly taking medication. The participants were checked for glucose tolerance according to the WHO (World Health Organization) classification (fasting glucose \<7 mmol/L(millimole per lite) and 2-hour blood glucose concentration after a 25g glucose load \<7.8 mmol/L). Ten (5 females and 5 males) were selected from fourteen using lottery sampling methods. Reference glucose and monofloral honeys were used as experimental foods. To determine the GI value, 25 grams of available carbohydrate was fed for ten healthy people in the morning after they have fasted for 11 hours overnight. After fasting blood sample was obtained. The study participants were consumed each honey and reference glucose served. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes after eating commenced. Blood glucose response (Area under the curve, AUCt) for test food was compared to the blood glucose response of reference glucose (AUCr). AUC was calculated using SAS (Statistical Analysis Software), 2002. Glycemic index (GI) was calculated using:

GI= AUCt/AUCr\*100

Where:

AUCt = Area Under the Curve for honey; AUCr = Area Under the Curve for the reference glucose

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of diabetes Disease
* Must be able to drink the honeys and reference glucose

Exclusion Criteria:

* Overweight, dieting, smoking, a family history of diabetes, pregnant, metabolic disorders, suffering from any illness or food allergy and regularly taking medication.
Vitamin B Complex Improved Exercise Performance and Anti-fatigue

The aim of the present study was to evaluate potential beneficial effects of TTFD® EX PLUS (Prince Pharmaceutical Co., Ltd., Yunlin County, Taiwan) on fatigue and ergogenic functions following physiological challenge. The test used a double-blind crossover design and supplementation for 28 days. 32 male and female 20-30 year-old subjects were divided into two groups in a balanced order according to each individual's initial maximal oxygen uptake and were assigned to receive a placebo with equal gender (non TTFD® EX PLUS with same color/day, n=16, 8 male and 8 female) or TTFD® EX PLUS (600mg/tablet/day, n=16, 8 male and 8 female) every morning. After the intervention, there were 28 days of wash-out, during which time the subjects did not receive further interventions.


Eligibility Criteria:
Inclusion Criteria:

* \>20 years old
* \>health

Exclusion Criteria:

* No smoking
* drinking habits
* no nutritional supplements or medications
* no food allergies
* normal liver and kidney function
* no diabetes and other chronic diseases
First Trimester Placental Assessment in the Screening of Preeclampsia and Intrauterine Growth Restriction

Preeclampsia (PE) and intrauterine growth restriction (IUGR) are clinical manifestations of placental insufficiency. These complications affect 5-15% of pregnancies, and are responsible for up to 20% of preterm births. Women who develop PE during pregnancy also have an increased risk for cardiovascular events, both at short and long term. This justifies the need to improve diagnostic tools to identify patients at risk for these complications. PE and IUGR are multifactorial entities. Screening algorithms should thus include several parameters to achieve high detection rates. Research has mainly focused in the analysis of biophysical and biochemical parameters, and the study of the placenta itself has not been included in current diagnostic strategies. Investigators hypothesize that detection rates of preeclampsia and intrauterine growth restriction could be improved by the study of placental characteristics in the first trimester of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* pregnancies with fetuses with CRL between 45 and 80mm
* absence of chromosomal abnormalities
* absence of congenital anomalies
* absence of congenital infections

Exclusion Criteria:

* patient not accepting to participate in the study
* multiple pregnancies
* pregnancies without ultrasonographic confirmation of gestational age
Association of Auditory Dysfunction With Retinal Ischemia in Behcet Disease

Auditory dysfunction is commonly detected in Behçet's disease (BD). Also, vestibular abnormalities as well as cochlear function affection have been found. The inflammatory process in BD may be the cause of audiometry abnormalities in those patients. The aim of this study is to assess hearing dysfunction in Behçet patients and its relation to retinal ischemia and disease activity using conventional pure-tone audiometry (cPTA), tympanogram and acoustic reflex

pure tone audiometry is a behavioral test used to measure hearing sensitivity. This measure involves the peripheral and central auditory systems. Pure-tone thresholds (PTTs) indicate the softest sound audible to an individual at least 50% of the time. Hearing sensitivity is plotted on an audiogram, which displays intensity as a function of frequency.

Speech audiometry employs speech signals to assess if the patient has problems hearing speech or speech in noise. Speech audiometry can be used to examine the processing ability and if it is affected by disorders of the middle ear, cochlea, auditory nerve, brainstem pathway, or auditory centers of the cortex.

Tympanogram is a test of middle ear functioning. This objective test also allows to view the functioning of the Eustachian Tube, the upper auditory pathways and the reflex contraction from the middle ear muscles. Impedance testing is crucial in distinguishing a conductive loss from a sensorineural hearing loss.

Optical coherence tomography angiography (OCT-A) for imaging the microvasculature of the retina and the choroid.

Behcet disease current activity form for assessment of disease activity range from 0 to 12 . 12 represents the highest disease activity. It depends on the symptoms present over the last 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All patients fulfill the International Criteria of behcet disease

Exclusion Criteria:

* age more than 50
* ear infection,
* ear trauma, acoustic trauma, or usage of ototoxic drugs.
* Also, associated systemic diseases that can affect the hearing as infectious diseases (e.g., mumps, CMV), granulomatous diseases (e.g., sarcoidosis, Wegner's granulomatosis), other autoimmune diseases (e.g., Rheumatoid arthritis, Cogan's syndrome, polyarteritis nodosa, relapsing polychondritis), and diseases of the bone (e.g., Paget's disease).