cyrilzakka/clinical-trials huggingface dataset:
Single-institution Register of Individuals Undergoing Cancer Genetic Risk Assessment

Single-centre, retrospective, prospective observational cohort study, based on the registration of data from users of the Oncology Genetics Outpatient Clinic

The primary objective of this study is to establish a register to collect and update over time the clinical, genetic and socio-demographic data of all patients who will be assessed for a suspected oncological genetic predisposition, in order to acquire information that can be used for conducting specific studies aimed at clarifying the various uncertainties that still characterise these diseases, such as the clinical significance and the genotype-phenotype correlations of many alterations in oncological predisposition genes oncological predisposition genes, the clinical and bio-pathological features predictive of a significant probability of identifying mutations in these genes, the efficacy of surveillance and prevention measures undertaken to reduce the risk oncological risk according to guidelines, the effectiveness of oncological therapies in patients with hereditary tumours in comparison with those with sporadic neoplasms sporadic neoplasms, risk perception, emotional impact and also interpersonal experiences associated with oncological genetic risk assessment.

These are objectives of primary interest to both the patient and public health (given the general frequency of oncological diseases), because the information acquired will make it possible to improve the general clinical management of all cancer patients and their families.

Eligibility Criteria:
Inclusion Criteria:

* participants aged 0 days or older at the time of genetic counselling
* obtaining a signed informed consent

Exclusion Criteria:

* misdiagnosis of oncological counselling during oncological genetic counselling
Improving Hypertension Care for Inner City Minorities

To improve long-term blood pressure BP) control in a predominantly African-American, low SES community of a large city.

BACKGROUND:

The study was in response to a demonstration and education initiative, "Improving Hypertensive Care for Inner City Minorities", which was reviewed and approved by the Clinical Applications and Prevention Advisory Committee in April 1992 and by the National Heart, Lung, and Blood Advisory Council in May 1992. The Request for Applications was released in October 1992.

DESIGN NARRATIVE:

Components of the program included a community education campaign, an educational intervention for private physicians, and major modifications in the process of care for hypertensives in a health care system that was the largest single provider to the target area. The intervention area was compared to a similar community in another part of the city which was served by different private and public providers. Pre- and post-intervention random samples of persons ages 18-74 were selected from each geographical area to assess the effectiveness of the program in reducing the prevalence of uncontrolled hypertension. The community intervention focused on improving awareness and need to maintain treatment. The private physician intervention focused on strategies for promoting long-term patient adherence. The public hospital clinic/systems components were: 1) educating providers, 2) instituting an evening clinic for the working poor, 3) providing tailored patient education programs which were culturally sensitive and did not require class attendance, and 4) implementing a program in the public hospital emergency center to identify and refer patients with undetected hypertension or hypertension not under regular care.

Efforts, including reminders and follow-up by community health center social workers, were used to keep patients active in treatment programs. The community intervention was directed by the co-investigator from Texas Southern University (TSU), an historically Black university located in the intervention area. He had extensive experience in community outreach. The intervention toward private physicians was directed by investigators from Baylor College of Medicine who had established clinical credibility in the physician community. The investigators from Baylor also had direct supervision over the physicians who provided care in the Harris County Hospital District (HCHD) public health care system. The HCHD was deeply committed to the project and had a high level of representation in all the planning phases.

Eligibility Criteria:
No eligibility criteria
Comparative Study of Sitagliptin and Gliclazide With Metformin in Type 2 Diabetes Patients With Glucotoxicity

This study compares the efficacy and safety of sitagliptin phosphate combined with gliclazide sustained-release tablets versus metformin in treatment-naïve patients with type 2 diabetes mellitus (T2DM) and glucotoxicity. The trial assesses glycemic control, patient compliance, and adverse events over a 12-week period using a randomized controlled design to determine the non-inferiority of the combined treatment.

In this single-center, prospective, randomized controlled non-inferiority study, treatment-naïve patients with T2DM and glucotoxicity were enrolled to evaluate the comparative efficacy and safety of two therapeutic regimens. The study investigates the combination of sitagliptin phosphate with gliclazide sustained-release tablets against metformin alone. Participants were randomized and monitored for 12 weeks, with primary outcomes focusing on fasting plasma glucose (FPG) levels, body weight changes, and hypoglycemic events. The study also explores the impact of treatment on β-cell function and insulin sensitivity, utilizing pharmacogenomic analysis to evaluate genetic factors influencing treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type 2 Diabetes Mellitus (T2DM) and glucotoxicity.
* Body Mass Index (BMI) between 18 and 30 kg/m².
* Fasting plasma glucose (FPG) levels ≥ 200 mg/dL and glycated hemoglobin (HbA1c) ≥ 9.0%.
* Normal hepatic and renal functions (ALT and AST ≤ 2.5 times the upper limit of normal; serum creatinine within normal limits).
* Capable of adhering to the prescribed anti-diabetic regimen and dietary guidelines.

Exclusion Criteria:

* Diagnosis of Type 1 Diabetes Mellitus.
* Hepatic or renal dysfunction (serum creatinine \> 1.2 times the upper limit of normal).
* Prior use of hypoglycemic medications before screening.
* History of severe ketosis, ketoacidosis, or hyperosmolar hyperglycemic state.
* Current treatment with corticosteroids, immunosuppressive agents, or cytotoxic drugs.
* Major systemic diseases (e.g., cardiovascular, respiratory, neurological).
* Pregnant or breastfeeding women.
* Known allergies to sitagliptin or gliclazide.
* Poor compliance potential as assessed by the investigator.
Collecting the Results of Multiple Trauma Patients and Find the Correlation of Morality and Mobility

Collect data about physiological examination values, blood test values and radiological examination results of patients admitted to the hospital for major trauma. There are different causes of mortality in multiple trauma patients. In this study, review the multiple symptoms and parameters of major trauma patients. We hope to understand and develop one feasible assessment model for emergency departments for enable rapid diagnosis and treatment evaluation about major trauma patients occurrence.

1. This is a retrospective study of patients admitted to the emergency department at a single center, focusing on reviewing their medical records and patient examination performance.
2. The parameters including hospital on-site records and patient examination result, physiological examination values, blood test values and radiological examination results.on the medical records of patients who visited emergency department are collected.
3. This study will explore how to improve the response and effectiveness of investigating patients when they are admitted to the hospital for major trauma.
4. Evaluate the effectiveness and efficiency of this operative model to increase the possibility of receiving medical examination, timely correct diagnosis on major trauma patients when they sent to the emergency department, and improve the hospital's manpower deployment plan.

Eligibility Criteria:
Inclusion Criteria:multiple trauma patients -

Exclusion Criteria:expired patients at emergency room

-
Reducing Cancer Disparities for American Indians in the Rural Intermountain West

The purpose of this demonstration is to evaluate the effectiveness of using community outreach workers (navigators) to help American Indians living in rural areas overcome barriers to appropriate cancer screening, diagnosis, and treatment.

Even for American Indians who have coverage with Medicare, disparities have been noted in the provision of cancer screening, diagnosis, and treatment. These disparities have been related to a variety of health-system, health-financing, geographic, and cultural barriers. We hypothesize that the use of lay community outreach workers will be an effective means of identifying and overcoming these barriers in order to improve the proportion of Medicare-eligible American Indians who receive recommended screening and diagnosis for prostate, breast, colon, and cervical cancer, and the proportion of individuals receiving appropriate treatment for prostate, breast, colon, cervical, and lung cancer. Community clusters randomized to this form of cancer navigation will be compared with community clusters randomized to receive educational outreach only.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Medicare Part B
* Self-reported American Indian

Exclusion Criteria:

* Have cancer other than study cancer
* Medicare Part C enrolled
Evaluation of the Efficacy of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia

This study aims to demonstrate that somatosensory rehabilitation of pain associated with static mechanical allodynia has superior efficacy over placebo treatment as well as over spontaneous changes.

This is a monocenter study. 45 patients will be enrolled in the study, allocated by randomization in 3 arms of 15 patients each.

During the 38 week duration of the study, enrolled patients will be assessed at:

* initial evaluation (first week of the study),
* intermediary evaluation for every week and every modification of intensity of pain,
* final evaluation at 10 weeks,
* follow-up evaluation at 6 months.

Eligibility Criteria:
Eligibility Criteria

1. Male or female patients aged ≥18 years;
2. Static mechanical allodynia for less than 3 months, whatever its etiology and topography;
3. Probable peripheral or central neuropathic pain or defined according to the IASP criteria;
4. Neuropathic pain diagnostic questionnaire DN4 score ≥ 4/10;
5. Chronic pain with average intensity ≥ 4/10;
6. Analgesic treatment unchanged within 15 days prior to screening, and not planned to be modified during the study;
7. Patient who can attend follow-up visits during the study;
8. Patient affiliated to a health insurance plan or entitled;
9. Patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.

Exclusion Criteria:

1. Patient with neuralgia (spontaneous pain) with or without allodynia;
2. Patient not able to participate actively to the rehabilitation exercises for physical reason, cognitive reason (ability to understand instructions) or behavioural reason (e.g. addiction...);
3. Patient with complex regional pain syndrome (type I);
4. Patients for whom cares cannot avoid any touch with allodynia area;
5. Patient previously treated by a transcutaneous electrical nerve stimulation (TENS);
6. Prior treatment by somatosensory rehabilitation;
7. Duration of stay in the medical center \< 11 weeks;
8. Patient with cognitive disorder;
9. Allodynia area of the patient presenting with conditions not recommended for vibrotactile stimulation: wound, unhealed nerve suture, recent skin transplantation, fragile organ such as eye.
Sequential Transplantation of UCBSCs and Islet Cells in Children and Adolescents With Monogenic Immunodeficiency T1DM

This study evaluates the efficacy of sequential transplantation of umbilical cord blood stem cells and islet cells in children with monogenic immunodeficiency type 1 diabetes mellitus. Umbilical cord blood stem cell transplantation will be performed first. Children with stable immune reconstruction will than receive islet cell transplantation.

Monogenic immunodeficiency type 1 diabetes mellitus (T1DM) usually onsets in early age and has a long course of treatment. Because of T cell deficiency, patients are prone to recurrent infection, hemorrhage, sepsis, colitis or complications of diabetes mellitus, which lead to early death.

New clinical treatment schemes have been explored and introduced around the world. Sequential transplantation of umbilical cord blood stem cells and islet cells is the latest treatment method for these children. Early treatment of monogenic immunodeficiency T1DM children can avoid disease-related organ toxicity, infection risk associated with chronic immunosuppression, and possible prevention of autoimmune endocrine organ damage. Thus, sequential transplantation of umbilical cord blood stem cells and islet cells is the only possible cure for those patients currently.

Eligibility Criteria:
Inclusion Criteria:

1.Type 1 diabetes mellitus children with genetic immunodeficiency

1. Meet the diagnostic criteria of type 1 diabetes mellitus: clinical manifestations of typical diabetes mellitus include polyphagia, polyuria, weight loss, or diabetic ketoacidosis, confirmed by blood sugar level, islet function and autoimmune antibody.
2. Existence of extrapancreatic organ damage: (1) inflammatory bowel disease, (2) impairment of renal function, (3) repeated infection of mouth, skin, anus or whole body, (4) immune hepatitis, (5) persistent chronic immune iridocyclitis, (6) immune adrenalinitis leading to adrenocortical dysfunction, (7) pituitary inflammation leading to hypophysis, (8) rheumatoid disease, (9) immune vasculitis, (10) systemic lupus erythematosus, (11) other organs besides thyroid function damage. Suffering from one or more of above diseases. Recurrence after receiving regular clinical treatment, including symptomatic treatment of organ protective drugs.
3. Gene mutation was found according to gene diagnosis: gene mutation was found by gene sequencing. Literature searches at home and abroad confirmed that the defect of the gene resulted in autoimmune or immune dysfunction, resulting in multiple organ dysfunction and poor prognosis.

Exclusion Criteria:

1. Mature and effective treatment methods are available.
2. HIV, HBV and HCV were positive.
3. A the active period of infection.
4. At the active stage of malignant tumors.
5. Combination of other fatal diseases.
6. Existence of mental and psychological diseases.
Ultrasound Imaging of Core Muscles Activity in Multiparous Women With Vaginal Laxity: A Cross-Sectional Study

This study aims to compare the ultrasound imaging of core muscles activity in multiparous women with vaginal laxity versus normal controls.

Vaginal laxity is characterized by the loss of elasticity in the vaginal structure and vaginal looseness, which leads to symptoms including sexual dysfunction, dyspareunia, chronic pelvic pain, and urinary incontinence. It is a symptom of pelvic floor dysfunction. Its mechanisms are not well understood and it is usually worse in women with multiparity.

Since the pelvic floor muscles (PFMs) are one of the core muscles that play a critical role in lumbopelvic stability, their impairment may affect the lumbopelvic area and the activity of other core muscles, like the transverse abdominis, lumbar multifidus, and diaphragm. Therefore, this study aims to compare the ultrasound imaging of core muscles activity in multiparous women with vaginal laxity versus normal controls.

Eligibility Criteria:
Inclusion Criteria:

1. The participants' age range from 35 to 45 years
2. their body mass index is 25-30 kg/m2,
3. The number of normal deliveries ≤ three times,
4. having a regular menstruation.
5. They participate in the study after at least two years from their last delivery.

Exclusion Criteria:

1. Prior history of disc prolapse and sacroiliac joints, symphysis pubic joint as well as lower limb problems, leg length discrepancy, and diastasis recti.
2. Surgery related to the spine, abdomen or pelvis.
3. Genital prolapse, urinary tract infection, and intrauterine device.
4. Diabetes, chest and/or cardiac disease.
5. Using any drugs for sexual dysfunction.
Development of a Novel HIV Risk Reduction Intervention for Abused Women

The purpose of this study is to develop and evaluate an HIV risk reduction intervention for women with a history of abuse.

The purpose of the proposed research is to pilot test an innovative, theoretically-guided sexual risk reduction intervention for women with a history of abuse. T intervention builds on previous findings suggesting that it is important to address the psychological consequences of abuse, as well as the typical antecedents of sexual risk behavior. To inform intervention development, women who reported a history of abuse were recruited to participate in key informant interviews. Based on interview findings and guided by theory and empirical precedent, a novel sexual risk reduction intervention was developed and refined. The intervention will be pilot tested with 80 women recruited from a publicly-funded clinic who report a history of abuse and current sexual risk behavior. These women will complete a computerized survey to assess abuse, adult sexual risk behavior, HIV-related information, safer sex motivation, behavioral skills, interpersonal trust, guilt, and powerlessness. Behavioral skills will also be assessed through role-plays and simulation scenarios. Women will be randomly assigned to the novel intervention or to a structurally equivalent intervention focused only on the psychological antecedents of sexual risk behavior. Three months after intervention completion, women will return to complete computerized interviews and behavioral skills assessments. The long-term goal of this research is to develop a feasible and effective sexual risk reduction intervention for women who have a history of abuse.

Eligibility Criteria:
Inclusion Criteria:

* history of abuse
* current sexual risk behavior

Exclusion Criteria:

* less than age 18
* impaired mentally
* do not speak English
* severely depressed or suicidal
* HIV+
Donor Breast Milk and Breastfeeding Rates

The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.

In late preterm infants and term neonates in the NICU whose mothers intend to breastfeed, this pilot study seeks to 1. determine study feasibility (consent rate, study completion rate, and rate of adherence to study diet), and 2. determine whether a dietary supplementation with donor human milk vs. formula improves: a. the percentage of maternal milk consumption at time of discharge from the NICU, or 7 days of age, whichever is later, b. breastfeeding rates and intent to breastfeed at 6-8 weeks chronological age, and c. breast feeding duration.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \>34 weeks and 0 days
* Mother's intent to breast feed
* NICU admission which is predicted to be at least 72 hours from time of admission

Exclusion Criteria:

* Confirmed genetic disorders and syndromes or other disorders known to affect growth and ability to bottle feed or breast feed (i.e., Trisomies)
* Common neonatal congenital anomalies (cardiac disease, congenital gastrointestinal disorders, etc)
* Commonly accepted contraindications for breast feeding (HIV, galactosemia, herpes lesions on the breast, maternal use of drugs that are considered contraindicated with breast feeding including marijuana)
* Infant admitted to the intensive care unit who is receiving invasive respiratory support (intubation) and/or ionotropic medications
* Any infant whose care is considered futile by the primary medical team
Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients

The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group, Control Group.

Background: Periodontitis and diabetes are both highly prevalent conditions, and the association between these two common diseases has been recognised by dental professionals for many years.

Aim: The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM).

Methods: This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group (TG) (Oral Hygiene Instructions (OHI) + scaling and root planing (RAR) using ultrasound device and Gracey curettes); Control Group (CG) (OHI + supragingival removal of plaque and calculus with ultrasonic device). CG patients receive salvage therapy if a significant worsening of their periodontal status and / or metabolic observed. Periodontal assesment (probing pocket depth (PPD), gingival index (GI), and plaque index (PI)) and systemic assesment (random blood sugar, glycosylated hemoglobin (HbA1C), and salivary cytokines) and bacterial asessment at baseline and 3, 6 months after treatment is performed. There will be a single examiner, blind and calibrated to improve reproducibility. The investigators' hypothesis is that non-surgical periodontal treatment reduces HbA1c, improving metabolic control in patients with DM

Eligibility Criteria:
Inclusion criteria were:

* Diagnostic of T2DM (diagnosed at least 1'5 years prior the study).
* Presence of generalized chronic periodontitis (With at least 9 teeth present and more than 30% of locations with probing depth (PD) and clinical attachment level (CAL) ≥4mm).

Exclusion criteria included:

* Patients who received antibiotics the last 15 days, or for a period longer than 10 days the last three months.
* Having received non-surgical periodontal treatment within the past 6 months.
* Pregnancy
* Significant change of medication for diabetes during the course of the study
* Evidence of other serious systemic disease (ASA III or IV) which may influence periodontal disease.
Ambu Aura GainTM Guided vs Non Guided in Edentulous Ambu Aura GainTM Without Gastric Tube in Endontolous Patient

The Ambu® Aura GainTM is a relatively new 2nd generation Supraglottic Airway Device (SGA) with a second port, providing gastric access to drain gastric content and air and it has an intergrated bite-block that helps avoiding rotation of the SGA.

It has been described and it is known from daily routine, that SGA in edentulous patient provide inferior oropharyngeal leak pressure (OLP).

The aim of the study is to evaluate if the placement of a gastric tube through the second orifice leads to better OLP and lowers the number of intervention needed for replacing the SGA.

The study also evaluates the OLP after 15 minutes and after 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

* ASA I - 3
* Signed informed consent
* Age 18 - 90 years
* Edentolous (or partial) patients
* Patients scheduled for elective surgery

Exclusion Criteria:

* Patients with a known or predicted difficult airway
* Patients with anatomical disorders in the upper airway, the oesophagus or the trachea
* Patients at risk for aspiration
* Body mass index (BMI) \> 40 kg/m2