cyrilzakka/clinical-trials huggingface dataset:
Gynecological Presentations Following Supracervical Hysterectomy

Supracervical hysterectomy is widely common and had many complications either immediate or delayed. In these patients bleeding, infection, chronic pelvic pain are common. In these patients cervical biopsy will be done and histopathological examinations will be done to evaluate the pathology in these patients.

* Study design and settings: Cross sectional descriptive studies
* Patients: 130 patients with hysterectomy recruited at Tanta University Hospital, gynecology clinics in central hospitals in Gharbia governorate will be recruited according inclusion and exclusion criteria. Inclusion criteria include all symptomatizing patients following supracervical hysterectomy, of any age, of any complaints. The
* Methods: All patients' demographic data, history, indication of hysterectomy, duration since operation, postoperative complications and their main complaint.

Eligibility Criteria:
Inclusion Criteria:

* Hysterectomy for benign pathologies

Exclusion Criteria:

* Hysterectomy for malignancy
Sexual Habits Affect Penis Size in Adulthood

Purpose: to assess in Kazakh adult males erect penis sizes, and study an influence of their natural physiological events and behavioral habits during their growing ages on their penile sizes nowadays.

Study Design: An observational cross-sectional survey pilot study using a correlational design with the intention-to-treat principle.

Participants. A total of 282 adult Kazakh males from the Republic of Kazakhstan and who have been visited at the urology units of three university centers in the biggest cities of the Republic of Kazakhstan (Astana, Almaty, and Karaganda) were prospectively included in the study, which took place between January 2020 and January 2021.

Measurements of the penis erect length and girth were by two doctor-urologists according to the method of Veale D et al. (2015).

Statistical analysis. Two-tailed Student's t-test, Pearson correlation and multivariate tests of the MANOVA and MANCOVA (body height as covariate) were used.

Sample size estimation. In a cross-sectional observational study in assessment of erect penis size of Kazakh adult males we supposed that the primary interest lies in assessment of erect penis sizes in the three cities (k=3). The investigators wish to be 95% sure of detecting when the mean erect penis sizes not exceed 1 mm (i.e., 1-β=0.95, and m1=1, m2=0). The standard deviation of erect penis size is likely to be 1.56 mm (i.e. SD=1.56) with a statistical power of 95% and significance level of 2.5% with the Bonferroni correction based on one-sided hypothesis testing. At the 5% Type I error rate (i.e., α=0.05), the sample size of the survey is 196.

Eligibility Criteria:
Inclusion Criteria:

* male gender aged from 23 to 35 years
* fill out the questionnaire
* BMI ≤ 29.9 kilogram per meter square
* a male who has at least one healthy native child
* no non-communicable chronic diseases.

Exclusion Criteria:

* female gender
* BMI ≥ 30.0 kilogram per meter square
* infertility
* erectile dysfunction, previous pelvic surgery, suspected hypogonadism, penile disease, or deformity
* specific treatment with androgens
* alcohol or drug abuse
* history of alcohol consumption ≥ 30 g/day within the past 5 years.
Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart

Primary Objective:

* To assess the effect of insulin glulisine on the post-prandial plasma glucose excursion during the first hour after a standard meal in comparison to insulin aspart in obese subjects with type 2 diabetes.

Secondary Objectives:

Pharmacodynamic objectives:

* To assess the effect of insulin glulisine on the postprandial plasma glucose excursion during 6 hours after a standard meal in comparison to insulin aspart.

Pharmacokinetic objective:

* To assess post-prandial plasma insulin excursion after a standard meal, in each treatment groups

Safety objective:

* To assess the safety of insulin glulisine in comparison to insulin aspart

Duration of treatment: two study days separated by a 7-day wash-out period

Duration of observation:

* screening period of 1-2 weeks, \>2 study days (with a wash-out period of 7 days between the study days),
* Follow-up visit (within 2 weeks after the end of the study treatment period).

Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 diabetes for at least one year
* treated with oral antidiabetic agents (OADs) for at least 6 months
* Baseline C-peptide ≥0.1 nmol/L
* BMI (body mass index) between 30 and 40 kg/m2
* HbA1c (glycosylated hemoglobin) \< 8.5%
* signed informed consent

Exclusion Criteria:

* type I diabetes mellitus
* current treatment with insulin
* pregnant and breast-feeding women
* any medication known to influence insulin sensitivity
* current treatment with systemic corticosteroids
* history of acute metabolic complications in the past 3 months
* recurrent severe hypoglycaemia or hypoglycaemic unawareness
* active proliferative diabetic retinopathy and known diabetic gastroparesis
* impaired hepatic function, as shown but not limited to ALT or AST above 2 times the upper limit of normal
* clinically relevant illness such as nephropathy and impaired renal function as shown by clearance \< 30 ml/min
* any history or presence of clinically relevant abnormality, medical condition (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, ocular or infectious disease; any acute infectious disease or signs of acute illness making implementation of the protocol or interpretation of the results difficult
* hypersensitivity to insulins or insulin analogs

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Impact of a Computerized Guidelines on the Management of Hypertension and Diabetes

The purpose is to determine wether an electronic decision support system based on national guidelines is effective to improve the follow-up and the treatment of two conditions: hypertension and diabetes, in primary care practices.

Existing computer-based ordering systems for physicians provide drug-centred checks but offer little assistance for optimizing the overall patient-centred treatment strategy.

The ASTI project aims :

1. to design a guideline-based decision support system for diabetic and/or hypertensive patients, to help general practitioners :

   1. to carry out procedures (clinical and biological tests) according to guidelines (the recommended procedure at the recommended moment), and to get a synthetic view of all the elements they need to follow-up the patient
   2. to avoid prescription errors and to improve compliance with therapeutic guidelines. The " critic mode " operates as a background process and corrects the physician's prescription on the basis of automatically triggered elementary rules that account for isolated guideline recommendations. The " guided mode " directs the physician to the best treatment by browsing a comprehensive guideline knowledge base represented as a decision tree.
2. To measure the impact of ASTI when it is implemented with an electronic medical record system. We adopt a randomized design, with the practice as the unit of randomization.

Eligibility Criteria:
Inclusion Criteria:

* Hypertension
* Mellitus diabetes
* Follow-up by GP's
PENTA Fosamprenavir Study

Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated for the treatment of HIV-infected adults, adolescents and children of 6 years of age and above for use in combination with other anti-HIV medicines. Safety data from two GlaxoSmithKline (GSK) clinical trials (APV29005 - involving twice-daily doses of FPV with or without RTV and APV20003 - with once daily dosing of FPV/RTV among 2-18 year olds) indicated that gastrointestinal events were the most commonly reported AEs, but that the majority of events were mild and of short duration. Treatment emergent grade 3 / 4 neutropenia was reported in 20% of children in the APV20003 trial; and neutropenia was identified as a potential safety concern by the European Medicines Agency (EMEA). The objectives of this study were to conduct an observational cohort study of the usage and safety of FPV/RTV in children and adolescents (aged 6 ≤ 18 years) with HIV infection in several European HIV paediatric cohorts. Data will be collected for 3 years (2008, 2009 and 2010).

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected children aged 6-18 years exposed to licensed paediatric dose of FPV/RTV January 1 2008 (or date of exposure to FPV if earlier to this but still exposed at 1/1/2008) from the participating cohorts

Exclusion Criteria:

-
Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients

The purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole.

Patients receive SCH 56592 oral suspension or fluconazole suspension for 14 days. Patients remain on study for 44 days total and are monitored for safety and efficacy of study treatment.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are at least 18 years old.
* Are HIV-positive.
* Have thrush (oropharyngeal candidiasis).
* Agree to practice sexual abstinence or use effective barrier methods of birth control (e.g., condoms).
* Are able to take study medication and return for clinic visits during the study.
* Are expected to live for at least 2 months.

Exclusion Criteria

You will not be eligible for this study if you:

* Have received protease inhibitors for the first time within 30 days prior to study entry.
* Have received certain medications.
* Have certain other types of fungal infections.
* Have certain types of cancer.
* Have received SCH 56592 within 3 months prior to study entry.
* Are pregnant or breast-feeding.
* Cannot take medications by mouth.
* Are allergic to azole drugs.
* Have certain medical conditions.
* Have been in this study before.
Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis Patients

The Londrina Activities of Daily Living Protocol was first developed for Chronic Obstructive Pulmonary Disease patients and was found to be valid and reliable, but there is no validity and reliability study of the Londrina Activities of Daily Living Protocol in IPF patients. The purpose of the study is to Examine the Validity and Reliability of the Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis (IPF) patients.

Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by a restrictive type of breathing disorder. In IPF patients, serious limitations occur in the activities of daily living (ADL) of the patients due to dyspnea and fatigue symptoms, therefore it is very important to evaluate the activities of daily living in this patient group. It is recommended to use protocols created from activities frequently used in daily life to evaluate ADL in chronic respiratory patients. Londrina Activities of Daily Living Protocol is a performance-based objective measurement method based on repetition of daily activities. Participants are asked to perform the activities defined in the protocol at the same speed they do at home, and the completion time of the protocol is recorded. The individual is asked to complete all stations in order from a designated starting line.

The Londrina Activities of Daily Living Protocol was first developed for Chronic Obstructive Pulmonary Disease patients and was found to be valid and reliable, but there is no validity and reliability study of the Londrina Activities of Daily Living Protocol in IPF patients. The purpose of our study is to Examine the Validity and Reliability of the Londrina Activities of Daily Living Protocol in IPF patients.

Eligibility Criteria:
Inclusion Criteria:

1. Being diagnosed with idiopathic pulmonary fibrosis (IPF) disease
2. Being 18 years or older
3. Being independent in daily living activities
4. Being able to read and understand Turkish

Exclusion Criteria:

1. The patient refuses to participate in the study
2. People with comorbidities that would make it impossible to perform any of the study evaluations (orthopedic pathology, uncontrolled cardiovascular or neurological conditions, psychiatric illness, etc.)
3. Presence of infection in the last 3 months
4. Those who show changes in their usual symptoms during the protocol
5. Patients who have difficulty understanding the commands given
6. Those who cannot complete all evaluations
Registry of Patients With Hematologic Disease and COVID-19 in Russia

This is an observational prospective cohort study to evaluate the clinical course and outcomes of COVID-19 and the underlying disease in patients with hematologic disease (malignant or non-malignant).

This is a web-based registry. After registration, physicians from hematology clinical centers and hospitals in Russia will receive access to the web platform for clinical trial management to fill in the online data collection form in a de-identified manner. This form includes questions about general clinical history of hematologic disease, manifestation, treatment, and the course of COVID-19, concomitant conditions, consequences on the hematologic disease, short-term and long-term outcomes. It will take approximately 10 min to answer the questions. Patients will be followed for 30 days after COVID-19 diagnosis and up to 6 months for hematologic disease outcomes and overall survival assessment.

Eligibility Criteria:
Inclusion Criteria

* Age 18 or older
* Any previously or currently diagnosed hematologic disease
* Laboratory confirmed or suspected (based on clinical symptoms and/or CT) COVID-19
* Known outcome of COVID-19 in case of retrospective data input (protocol allows retrospective data input for patients who were prospectively followed in local centers)

Exclusion Criteria

• Loss of follow-up within 30 days after COVID-19 diagnosis
the Effect of Pregabalin on Postoperative Pain and Opioid Consumption in Spine Surgery

The effect of pregabalin on post-operative pain and opioid consumption in spine surgery, a prospective, randomized, controlled study

Aim of the work:

The aim of our study is to compare the analgesic effect of pre-emptive oral pregabalin 150mg on acute postoperative pain and opioid consumption in spine surgery. Evaluated by visual analog scale (VAS)

primary outcome measure is the total amount of rescue morphine received by patients for 24h postoperatively.

secondary outcome measures include level of acute postoperative pain by VAS, and duration of hospital stay

Patients and methods :

This study will be carried out after being approved from the Medical Research Ethical Committee, Faculty of Medicine, Assiut University, Assiut, Egypt, and after obtaining a written informed consents from all participating patients.

inclusion criteria: This prospective randomized clinical study will include eighty patients with ASA I-II, aged 18-60 years scheduled for spine surgery

Exclusion criteria : Excluded from the study are patients with known allergy to the study drugs, significant cardiac, respiratory, renal, CNS or hepatic disease, drug or alcohol abuse, pregnant women, patients refusing participation and psychiatric or mental illness that would interfere with perception and assessment of pain.

Eligibility Criteria:
Inclusion Criteria:

* : This prospective randomized clinical study will include eighty patients with ASA I-II, aged 18-60 years scheduled for spine surgery

Exclusion Criteria:

* : Excluded from the study are patients with known allergy to the study drugs, significant cardiac, respiratory, renal, CNS or hepatic disease, drug or alcohol abuse, pregnant women, patients refusing participation and psychiatric or mental illness that would interfere with perception and assessment of pain.
Proton Magnetic Resonance Spectroscopy of Normal Breast Tissues in Women Volunteers

Magnetic resonance spectroscopy (MRS) is a diagnostic technique in MRI that distinguishes various metabolites on the basis of their slightly different chemical shifts or resonance frequencies. The Proton is the most abundant nucleus in the body. We will try to establish the typical proton MRS pattern of normal women breasts to be a guideline for future further investigations.

There are few reports regarding proton MRS in normal female breasts. The fibroglandular tissues and fat are the two major gross components in the breast. The water content in the fibroglandular tissues is much higher than that in the fat. There is still no documented report discussing proton MRS in normal female breasts of premenopausal and postmenopausal women. Our study is to evaluate the proton MRS findings among normal premenopausal and postmenopausal women breasts, to find out if there are statistical differences on the main proton MRS patterns, water and lipid peak intensities and ratios between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* women age ranged 30 years of age or older, with normal mammograms or ultrasound in recent 3 months

Exclusion Criteria:

* any women not fulfilling the inclusion criteria
Chatbot Effectiveness for Improving Mental Health and Reducing Stress in Nursing Students

This study aims to evaluate the effectiveness of using a chatbot to improve mental health and reduce stress among nursing students during their internships. The study will be conducted through convenient sampling of nursing students from a technology university in southern Taiwan. Students will be divided into experimental and control groups to compare differences in mental health and stress levels after receiving support from the chatbot. Expected outcomes include gaining a better understanding of the fundamental characteristics of nursing students and their mental health and stress levels during internships. The results are expected to demonstrate that the chatbot can aid nursing students in handling typical internship issues, stress, and challenges, as well as in accessing mental health resources.

Background: The number of suicides and the crude death rate among adolescents aged 15-24 have been gradually increasing. Nursing students experience greater stress compared to students from other disciplines, primarily due to the unfamiliar clinical environment, concerns about managing internships, and worries about their ability to accurately judge and handle patient conditions due to a lack of experience. The diverse and highly complex nature of clinical practice sites significantly impacts the mental health and stress levels of nursing students during their internships. Therefore, it is crucial to pay attention to the cultivation of nursing students as they enter clinical practice. In response to changing times, mobile devices and chatbot tools are critically important support resources for students.Objective:The aim is to understand how chatbot can help nursing students improve their mental health and stress during their internships. Methods:This study will employ a quasi-experimental design and will use convenience sampling to recruit nursing students from a technology university in southern Taiwan. Structured questionnaires will be used to collect data on basic demographic information, a brief health scale, and a clinical internship stress scale. It is estimated that 55 students will be recruited for both the experimental and control groups.Statistical analyses will be conducted using SPSS 28.0 software. Expected Outcomes: The expected outcomes of this study include gaining a better understanding of the basic attributes of nursing students and their mental health and stress levels during internships. The overall findings will serve as a reference for educational planning for nursing internship students and emphasize the importance of technology-assisted connections in practical learning within teaching policies.

Eligibility Criteria:
Inclusion Criteria:

Nursing students from the daytime four-year technical program at a university in southern Taiwan who have been scheduled for clinical internships.

Students who agree to participate in the study.

Exclusion Criteria:

Students who are only partially completing their internships (fragmented internship students).

Students who are unable to comply with the intervention measures.
A Mindfulness-based Intervention for Older Women With Low Sexual Desire

The overall aim of this research is to adapt and pilot test a multi-component, mindfulness-based behavioral intervention for women age 50 and older with low sexual desire.

Specifically, the investigators will conduct a pilot randomized controlled trial to assess the feasibility, acceptability, and preliminary efficacy of the intervention. Fifty women will be randomized to the mindfulness intervention or an educational control group. Both groups will be conducted in 3 sessions over 6 weeks in groups of 10 women. Feasibility, acceptability, facilitators, and barriers will be assessed by surveys after each session and after intervention completion. Preliminary efficacy will be assessed by measures of sexual desire, sexual function, and overall sexual satisfaction at 6 and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* meet criteria for a diagnosis of Female Sexual Interest/Arousal Disorder
* English-speaking
* have a current sexual partner with whom they are or would like to be sexually active

Exclusion Criteria:

* active major depression
* active substance abuse
* current intimate partner violence
* partner with active major depression
* partner with active major substance abuse
* significant relationship dissatisfaction
* current use of antidepressants
* untreated dyspareunia (sexual pain)
The Effect of Eating Frequency on Blood Pressure

The primary purpose of this study is to identify the effect of meal frequency on blood pressure (BP) levels of individuals.

Migration studies, observational epidemiology and clinical trial data indicate that causes of adverse BP levels are mainly environmental , including lifestyle under which dietary factors play a role. Therefore, lifestyle modification is part of the current American Heart Association recommendations for prevention and control of adverse BP levels.

Although the effects of nutrients and foods on BP have been studied extensively, other dietetic factors such as eating frequency and number of meals in a day have been less thoroughly investigated and warrant further research to explore their possible positive effect on BP.

Eligibility Criteria:
Inclusion Criteria:

Healthy individuals aged 35-70 years with prehypertension (systolic/diastolic BP 120-139/80-89 mm Hg) BMI 20-30 kg/m2 non-smoking non alcoholic drinkers

Exclusion Criteria:

* Weight change of ≥ 3kg in the preceding 2 months
* Current smokers
* Substance abuse
* Alcohol intake
* Pregnancy
* Diabetes
* Cardiovascular disease
* Cancer
* Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
* Kidney disease
* Liver disease
* Pancreatitis
* Use of medications including: anti inflammatory drugs or steroids, antihypertensive drugs, cholesterol lowering medication, androgens, phenytoin, erythromycin or thyroid hormones.