cyrilzakka/clinical-trials huggingface dataset:
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma

The goal of this observational cohort study is to assess the yield of preoperative endoscopic ultrasound focussed on lymph nodes in patients with presumed resectable perihilar (pCCA), intrahepatic (iCCA) or mid-common bile duct (CBD) cholangiocarcinoma. The main questions it aims to answer is:

1. The number of patients precluded from surgical work-up due to positive regional or extraregional lymph nodes identified by endoscopic ultrasound guided tissue acquisition
2. Characteristics during endoscopic ultrasound of lymph nodes associated with malignancy


Eligibility Criteria:
Inclusion Criteria:

* Presumed resectable pCCA OR
* Presumed resectable iCCA OR
* Presumed resectable mid-common bile duct CCA OR
* Presumed unresectable pCCA worked-up for Liver Transplantation AND
* Written informed consent must be given according to International Council on Harmonisation/Good Clinical Practice guidelines, and national/local regulations AND
* Age \> 18 years.

Exclusion Criteria:

* Patients with a history of treated CCA
* Patients with CCA for which a pancreatoduodenectomy is indicated, based on cross-sectional imaging
* Patients with a history of treated liver malignancy
* Patients with a contra-indication for EUS-tissue acquisition (f.e. uncorrectable coagulopathy or platelet disorder), in line with current clinical practice
DPBRN Assessment of Caries Diagnosis & Caries Treatment

The purpose of this study was to determine what methods Dental PBRN dentists use for diagnosis, prevention, and treatment of dental decay.

The purpose of this project was to identify methods that Dental Practice-Based Research Network (DPBRN) dentist used to diagnose and treat caries lesions. The aims of the "Assessment of caries diagnosis and caries treatment" study were to: (1) quantify the percentages of DPBRN dentists who reported using selected methods for caries diagnosis; (2) quantify the percentage of DPBRN dentists who reported using a caries-risk assessment protocol of any variety; (3) quantify the percentages of DPBRN dentists who reported intervening surgically at carious states E1, E2, D1, D2, or D3; and (4) test the hypothesis that reported use of a caries-risk assessment protocol was associated with a higher likelihood of reporting use of a preventive program.

The aims were met by enrolling at least 200 DPBRN practitioner-investigators in the study, each of whom completed a 10-page questionnaire about caries diagnosis and treatment assessment. Findings from "Assessment of Caries diagnosis and caries treatment" study will be related to treatment that is actually delivered as determined in "Reasons for placing the first restoration on permanent tooth surfaces" study and "Reasons for replacement or repair of dental restorations" study. This group of three studies will lay a critical foundation for subsequent intervention studies designed to move the latest scientific advances about caries diagnosis and treatment into daily clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Practitioner investigators must have been enrolled in DPBRN and do at least some restorative dentistry in their practices.
Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000).

Robot-assisted surgery has been successfully adopted rapidly over the last decade. Robotic technology with tridimensional imaging can improve operating dexterity, visualization of difficult anatomic locations. This is a prospective study aims to evaluate the safety and effectiveness of the domestic surgical robot.

In this clinical trial, the subjects will be randomly divided into two groups, and the urological typical surgical procedures (prostatectomy, and partial or radical nephrectomy) will be performed with the endoscopic surgical instrument control system SP1000 and IS3000.And the non-inferiorly comparison will be made between the surgical results of two systems to verify the safety and effectiveness of the endoscopic surgical instrument control system (SP1000).

Eligibility Criteria:
Inclusion Criteria:

1. Any male or female age from 18 to 80
2. BMI 18-30kg/m2
3. Have urological surgery indications (cystectomy, prostatectomy, and nephrectomy)
4. Patients with physiologic conditions capable of receiving laparoscopic surgery
5. Be able to cooperate and complete the follow-up and related examinations
6. Volunteer to participate in this study and sign the informed consen

Exclusion Criteria:

1. The researchers assess patients with severe cardiovascular or circulatory disease and cannot tolerate the surgery
2. History of epilepsy or mental illness
3. Pregnant and lactation
4. Surgery history at the relevant surgical site, which is considered to influence surgical procedures
5. Severe allergic or addiction of drug and alcohol
6. Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastasis disease
7. Inability to understand the trial or complete the follow-up
8. Participated in other therapeutic clinical trials within 90 days
9. Patients who had undergone major operation and major trauma within 28 days prior to enrollment, which the researchers considered to have an impact on the outcome of surgery
10. Patients deemed unsuitable to participate in this trial by researchers
A Study to Evaluate the Impact of Care4Today® IBD, a Smart System to Facilitate the Management of Crohn's Disease by Patients and Health Care Providers

The purpose of this study is to describe the Crohn's Disease (CD)-related secondary healthcare resource utilisation of patients in the 6 months pre- and 12 months post-activation of Care4Today® inflammatory bowel disease (C4T IBD) alongside standard of care (SOC) in the management of CD.


Eligibility Criteria:
Inclusion Criteria:

* Participants with moderate to severe Crohn's disease (CD), diagnosed at least 6 months prior to index date, as documented by the treating healthcare professional (HCP)
* Participants with at least 6 months of continuous care in the study centre prior to index date
* Participants who have agreed to install Care4Today® inflammatory bowel disease (C4T IBD) on their iOS or android smartphone as part of their management of CD
* Participants providing informed written consent to participate in the study from the date of activation (including installation and linkage to HCP web interface) of the C4T IBD app on his/her smartphone

Exclusion Criteria:

* Participants with presence of ileorectal or ileal pouch-anal anastomosis documented in their medical records
* Participants in remission for over 2 years as documented in their medical records
* Participants participating in an interventional clinical trial
* Participants participating in an observational study where the protocol interferes with the C4T study in the opinion of the principal investigator at each site
* Participants with insufficient command of English to interact effectively with C4T IBD and complete the study questionnaires in the opinion of the principal investigator at each site
* Participants unable or unwilling to provide their informed written consent to participate in the study
Effect of Fructose Reduction on Non-alcoholic Fatty Liver Disease (NAFLD) and Metabolic Syndrome in Overweight Children

The aim of the present study is to find out if a dietary intervention mainly focusing on fructose reduction has a preventive effect on the development and progression of NAFLD and the metabolic syndrome in overweight children.

In the intervention study a total of 100 overweight and 50 normal weight children, aged 5-8 years have to be included. At the beginning, two 24-h dietary recalls are performed to assess nutritional intake and fructose consumption. Anthropometric parameters (body weight and height) are measured to calculate BMI and BMI-SDS of the children. Physical activity during leisure time as well as socio-demographic status and "family background" are assessed using different questionnaires. An ultrasound examination of the liver is performed in all participants for detection of signs of fatty liver. From each child included in the study a fasting blood sample is taken to determine the following blood parameters: ALT, AST, γ-GT, uric acid, blood lipids (TG, HDL, LDL, Total cholesterol), blood alcohol, PAI-1 and endotoxin concentration. A part of the blood sample is used for DNA-analysis. In all children systolic (SBP) and diastolic (DBP) blood pressure are also measured. An oral glucose tolerance test (OGTT) is performed after an overnight fast of 12 h (glucose concentration: 1.75 g/kg body weight, maximum 75g). Simultaneously a glucose hydrogen breath test is performed to assess small intestinal bacterial overgrowth (SIBO). After the check-ups at the beginning of the study, children are divided into two study groups: the intervention group and the control group. Based on the daily fructose intake assessed at the beginning of the study, children participating in the intervention group are advised to reduce their daily fructose intake by 50%. In the first study year, every three months and in the second study year, every six months, nutritional counseling is repeated in small groups in which parents and children are separately trained. If families participating in the control group wish, they receive a dietary counseling based on the references of the "DGE" at the beginning of the study. After the first and the second study year the examinations are repeated in all participants (ultrasound examination only after the second study year).

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 90 percentile for overweight children
* BMI \< 90 percentile for normal weight children
* no signs of fatty liver (maximal fatty liver grade one or slightly elevated ALT, AST, γ-GT concentrations)
* children with metabolic disorders (prehypertension, high triglyceride, cholesterol or fasting glucose levels) are included with agreement of the pediatrics

Exclusion Criteria:

* liver disease (e.g. steatohepatitis)
* diabetes type 1 and 2
* renal insufficiency
* chronic disease of the gastrointestinal tract
* taking drugs affecting lipid or glucose metabolism
Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness

Aim of the study is to perform a pilot study to assess the impact of Botulinum toxin on muscle tone, and caregiver burden in individuals who are cognitively impaired and who are fully dependent.

The primary objective is to confirm proof of principle that paratonic rigidity and the consequences associated with it can be reduced with injection of Botulinum toxin injections resulting in reduced care-giver burden.

The secondary objectives are to determine optimal time points for evaluation of efficacy in this patient population and whether the time period is sufficient for washout of Botulinum toxin effect; determine most salient and sensitive outcome measures; identify obstacles in data gathering; and lastly, to determine feasibility of battery of assessments in this pilot study.


Eligibility Criteria:
Inclusion Criteria:

* Severe cognitive impairment (complete dependency in all activities of daily living (ADLs)
* Diagnosis of Alzheimer's disease, vascular dementia,or frontotemporal dementia
* Score\> 3 on the paratonic assessment instrument, with paratonic rigidity in an arm(s) interfering in the provision of care

Exclusion Criteria:

* Alternate etiologies for increased tone
* Botulinum toxin 6 months preceding the study
Use of the Modified PUQE Score on Admitted Cases of Hyperemesis Gravidarum (HG) to Guide Response to Treatment

Use of the PUQE score to judge the need for admission in cases of hyperemesis gravidarum Evaluation of the response to treatment by the PUQE score

Nausea and nomiting of Pregnancy (NVP) affects up to 80% of pregnant women . Severe NVP is one of the most common indications for hospital admission among pregnant women, with typical stays of between 3 and 4 days . Onset of NVP is in the first trimester. It typically starts between the fourth and seventh weeks of gestation, peaks in approximately the ninth week and resolves by the 20th week in 90% of women. If the initial onset is after 10+6 weeks of gestation, other causes need to be considered There is a broad spectrum of nausea and vomiting of pregnancy (NVP) severity, ranging from mild, occasional nausea to severe, intractable vomiting requiring hospitalisation (hyperemesis gravidarum). Hyperemesis gravidarum(HG) is defined severe, protracted nausea and vomiting associated with weight loss of more than 5% of prepregnancy weight, dehydration and electrolyte imbalances. The exact underlying pathophysiology is unknown, but etiology is believed to be multifactorial, including endocrine, gastrointestinal and environmental factors.5 Risk factors include lower maternal age, primigravidity, lower socioeconomic background and non-smoking status.

Admission for hyperemesis gravidarum depends on clinical impression by the attending or referring physician. There is a need for classification the severity of NVP to restrict admission to those who need admission. An objective and validated index of nausea and vomiting such as the Pregnancy-Unique Quantification of Emesis (PUQE) score may be used for this purpose.

This questionnaire contains three questions regarding the time-span of nausea, vomiting and retching respectively, as well as one question assessing the global psychological and physical quality of life (QOL). Initially the questionnaire evaluated symptoms during last 12 hours, but it has been modified to encompass 24 hours as well as the whole of first trimester of pregnancy The PUQE questionnaire was used in several studies to assess the effect of antiemetic treatments for emesis and hyperemesis . In this study, the role of PUQE in evaluating need for inpatient admission will be studied. Also, the response to treatment inside the hospital will be assessed

Eligibility Criteria:
Inclusion Criteria:

* women hospitalized due to hyperemesis gravidarum with at least two out of three criteria; dehydration, weight loss \> 5% of prepregnancy weight (if known) or electrolyte imbalance/ketonuria.
* Gestational age between 6_16 weeks.

Exclusion Criteria:

1. Women Suffered from other diseases causing nausea and vomiting :

   * gastritis
   * renal diseases
   * Hepatic disorders
   * Throid disorders
2. the gestational length was more than 16 weeks at inclusion.
Effect of Atorvastatin Administration Before Primary Percutaneous Coronary Intervention

The purpose of this study to determine whether statin pretreatment decrease myocardial infarct size in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* Presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
* ST segment elevation more than 1 mm in two or more contiguous leads or presumably a new onset left bundle branch blockage

Exclusion Criteria:

* Cardiogenic shock
* History of myocardial infarction
* Chronic liver disease
* Previous or current statin use
Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia Following Laparoscopic Cholecystectomy

The aim of this study is to evaluate analgesic effect of ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia in pain control following laparoscopic cholecystectomy.

To study the difference between the effects of ultrasound-guided bilateral retrolaminar block and ultrasound-guided thoracic epidural analgesia on pain control following laparoscopic cholecystectomy. To relief pain and improve satisfaction in patients undergoing laparoscopic cholecystectomy at Zagazig university hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the patient.
* Age: 21-45 years old.
* Sex: both sex (males and females).
* Physical status: ASA 1\& II.
* BMI = (25-35 kg/m2).
* Type of operation: elective laparoscopic cholecystectomy

Exclusion Criteria:

* Altered mental state.
* Patients with known history of allergy to study drugs.
* Advanced hepatic, renal, cardiovascular, and respiratory diseases.
* Patients with chronic pain.
* Patients receiving anticoagulants.
* Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.
The Effects of Chia on Overweight/Obese Women

The purpose of the study is to examine the effect of chia seed consumption on body composition, blood pressure, blood glucose, satiety, mood, joint pain, and dietary displacement in overweight and obese females (18-45years). It is hypothesized that consuming chia seeds will bring about a positive change in body composition (lower % body fat), satiety, mood, joint pain, and blood pressure, lower blood glucose levels, increased fiber and improved nutrient intake, in overweight/ obese females.

Specific Objectives: 1. Determine if chia seed diet addition of 10% of Kcals (CHIA) positively changes body composition in young, healthy, overweight/obese people (Tanita scale). A) Determine if CHIA will decrease blood pressure (monitor). 2. Determine if CHIA will decrease blood glucose (draw) 3. Determine if CHIA increases satiety and improves diet (recordings). 4. Determine if CHIA will decrease joint pain (questionnaire). 5. Determine if CHIA will increase positive mood changes (questionnaires) and increase blood serotonin levels (draw).

Eligibility Criteria:
Inclusion Criteria:

* are a female.
* are between the ages of 18 and 45.
* are not averse to consuming chia seeds on a regular basis (at least six weeks).
* have not taken any medication for any chronic disease (heart, diabetes, cancer) for twelve weeks.
* have not taken any steroid or hormone medication in the last eight weeks, excluding birth control pills...
* do not consume excess amounts of nuts and seeds. - do not consume alcohol on a regular basis.
* are not currently on a diet plan.
* are not pregnant or plan to become pregnant.

Exclusion Criteria:

* are a child, teenager, woman, or male younger than 18 or older than 45.
* eat large quantities of chia seeds on a regular basis.
* are taking any steroid or hormone medication (other than birth control pills). - are taking laxatives or fiber containing supplements on a regular basis.
* are pregnant or become pregnant.
* are currently on a diet plan.
* have a known allergy to seeds.
* consume excess amounts of seeds or nuts.
* consume alcohol on a regular basis.
* have a pacemaker or metal pins or plates in the body.
Comparison of Popular Weight Loss Diets

This study will compare the safety and effectiveness of three popular weight loss plans. These plans will be compared with the USDA Dietary Guidelines.

Obesity is the single most significant, nutrition-related health issue of the new millennium. Several "medical experts" have designed and promoted weight loss diets that dramatically differ from one another and from the USDA Dietary Guidelines. These diets have gained surprisingly widespread and persistent popularity among Americans despite the lack of evidence supporting their claims. This clinical trial will provide preliminary feasibility data for a full-scale study that will examine health outcomes (e.g., benefits, risks, success) of three popular weight loss diets. The study will investigate behavioral and physiological factors that influence adherence and retention to these diet plans.

Overweight women will be randomly assigned to one of four diets for 1 year: Atkins (extremely low carbohydrate), Zone (low carbohydrate, high protein), Ornish (very low fat), or USDA/Food Pyramid (high carbohydrate/moderate-low fat). Behavioral and physiological data will be collected. Participants attend study visits at baseline, 8 weeks, 6 months, and 1 year. At these visits, measurements will include that will include weight and blood pressure measurements and blood tests. Participants will be asked to complete ten questionnaires over the course of the study to assess behavior and appetite. Participants will also undergo a DEXA scan to assess body composition.

Eligibility Criteria:
Inclusion Criteria

* Body mass index (BMI) between 27 and 40 kg/m2
* Weight stable for last 2 months
* Not actively on a weight loss plan
* No plans to move from the area over the next 2 years
* Willing to accept random assignment

Exclusion Criteria

* Pregnant or breastfeeding
* Within 6 months of giving birth or planning to become pregnant in the next 2 years
* Diabetes (type 1 or 2) or history of gestational diabetes
* Renal or liver disease, active neoplasms, or recent myocardial infarction
* Hyper- or hypothyroidism
* Lipid lowering medications or medications known to affect weight/energy expenditure
* Excessive alcohol intake (self-reported, \> 3 drinks/day)
* Postmenopausal, including surgical menopause
* Currently under psychiatric care or severely clinically depressed (\> 17 on Beck Inventory)
The Use of Abdominal Binders in Patients Undergoing Cesarean Sections

To see if the use of Abdominal Binders improves patients out comes after cesarean delivery

Inclusion: All patients admitted to labor and delivery

Consented patients who had a cesarean delivery will be randomized using a number table to receive or not receive an abdominal binder.

Outcomes: On postoperative days 1 and 2, patients were asked to complete a pain visual analog scale and the validated Symptom Distress Scale. Postoperative hemoglobin and hematocrit were also recorded.

Eligibility Criteria:
Inclusion Criteria:

Women undergoing cesarean section for any indication

Exclusion Criteria:

* unable to give consent
Effects of Somatostatin on ADPKD Heart

Autosomal dominant polycystic kidney disease (ADPKD) is associated with early onset hypertension and left ventricular (LV) hypertrophy. Since LV hypertrophy is associated with LV diastolic function impairment, we aimed to assess the changes over time of LV diastolic function in ADPKD patients and whether they were affected by the treatment with the somatostatin analogue, octreotide.

35 ADPKD patients (14 males) aged 34±8 years (mean glomerular filtration rate 82±26 mL/min/1.73m2) were randomly assigned to 36 month treatment with placebo (n=18) or octreotide (n=17). Clinical and echocardiography parameters were evaluated at baseline and study end. LV mass (M) and ejection fraction (EF) were calculated according to Devereux formula and biplane Simpson's algorithm, respectively. LV filling was assessed by mitral and pulmonary vein flow velocity curves and mitral annulus early diastolic velocity peak (Ea) by tissue Doppler imaging.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of autosomal dominant polycystic kidney disease
* glomerular filtration rate grater than 40 ml/min

Exclusion Criteria:

* diabetes mellitus
* proteinuria greater than 1 g/24 hours
* significant glomerular disease
* urinary tract lithiasis and infections
* symptomatic gallstones
* biliary sludge
* cancer
* pregnant women
* lactanting women