cyrilzakka/clinical-trials huggingface dataset:
Eating Away from Home and Risk of All-cause Mortality

The proposed study will test the hypothesis that frequency of eating away from home meals is independently related to the prospective risk of mortality in the US population. The study will use public-domain mortality linked data from US national Surveys to address this question.

This study uses public domain data collected in the National Health and Nutrition Examination Surveys (NHANES) conducted in 1999-2000, 2001-2002, and 2003-2004 by the National Center for Health Statistics. Data on frequency of eating restaurant meals were collected at that time. The surveys have been linked to the National Death Index and mortality status information is available in public-release files. The investigators aim to examine if exposure to restaurant meals at baseline is prospectively linked to the risk of mortality. All data are anonymized and available in the public domain.

Eligibility Criteria:
Inclusion Criteria:

* National Health and Nutrition Examination Surveys, 1999-2004, respondent
* Aged 40 or older at baseline

Exclusion Criteria:

* Pregnant or lactating
* No mobile examination center exam
* No exposure information
* No National Death Index linkage
* No followup time
Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis

Cystic Fibrosis (CF) is a lifelong condition which causes the lungs and digestive system to become clogged with thick, sticky mucus. This leads to recurrent lung infections and reduced nutrients absorption from food. The average age at death is 26 years, usually from respiratory failure. Nonetheless, the nutritional status of people with CF (PWCF) is important help them live healthier and longer.

It is recommended that adult with CF achieve a BMI of 23 for males and 22 for females. However, fewer than 50% adult with CF achieved that target BMI despite effective nutritional support to help support weight gain. There is a clear need for a behavioural intervention that can help PWCF use the available nutritional support.

This is a feasibility study to try out a multi-component behavioural intervention. The intervention is designed to help PWCF use their nutritional support to gain weight. It will focus on testing the methods and procedures to be used on a larger scale, improving the behavioural intervention and estimating the how many people are needed for the larger trial.

All eligible 75 PWCF in Sheffield will be invited to participate. The investigators anticipate recruiting 30 participants. Participants will be divided into two groups. The first group receive the behavioural intervention immediately. The second group receive the intervention after 3 months. All participants will be followed up for 6 months. Data will be collected every 6 weeks during clinic reviews.

These two groups will be compared against each other to estimate the potential impact of the behavioural intervention. The investigators will also interview some of the participants at the end of the study period to improve the intervention and the study processes based on participant feedback.

The investigators hypothesised that this study will recruit around 30 participants, around 80% of the participants will complete the study, a single full-time investigator can deliver the intervention to 15 participants over 3 months and data collection will be thorough (with less than 5% missing data). The investigators also hypothesised that this feasibility study will help improve the intervention and help the design of a larger trial.


Eligibility Criteria:
Inclusion Criteria:

* adult people with CF looked after at the Sheffield Adult CF Unit
* best BMI of \< 23 for males and \< 22 for females between Oct '12 and Oct '13

Exclusion Criteria:

* patients in the palliative phase of disease
* patients who are pregnant
* patients who have no capacity to consent to participate in the study
* patients who have no IT facilities to use the web-based food diary
* patients who are unable to communicate by telephone for coaching
A Comparison of Ultrasound and Nerve Stimulator Techniques for Nerve Localization in Regional Anesthesia

The primary objective of this study is to compare ultrasound versus nerve stimulator techniques for nerve localization when performing peripheral nerve blocks. Specifically the investigators will be performing Popliteal, Femoral, and Interscalene nerve blocks. The investigators will be looking for differences in 1) time taken to locate the target nerve and inject local anesthetic 2) time from injection of local anesthetic to adequate surgical anesthesia 3) effectiveness of block 4) incidence of vascular puncture 5) incidence of adverse events 6) patient satisfaction.

After obtaining informed consent, subjects will be randomized to either the ultrasound or nerve stimulator groups as the method for nerve localization prior to peripheral block placement.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical status I-III
* Arthroscopic knee surgery or Lower leg/foot surgery as well as shoulder arthroscopy
* Outpatient status
* Patient preference for a regional anesthetic
* Subjects should be capable of giving informed consent

Exclusion Criteria:

* Allergy to:

  * Local anesthetics
  * Hydromorphone
  * Propofol
  * Midazolam
* Patient refusal
* Infection at the injection site
* Peripheral Neuropathy
Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism

Aim 1.Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs glycemic control via effects on insulin sensitivity and insulin secretion.

Aim 2. Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs insulin secretion and insulin sensitivity via an mineralocorticoid-receptor dependent mechanism.

In aim 1 subjects are randomized to cross over between an 8 day high salt and 8 day low salt diet and assessments are made.

In aim 2, subjects are randomized to a 2x2 cross over study with an 8 day low salt diet and either eplerenone 50mg or amlodipine 5mg.

Eligibility Criteria:
Inclusion Criteria:

1. Ambulatory subjects, 18 to 70 years of age, inclusive
2. For female subjects, the following conditions must be met:

   1. postmenopausal status for at least 1 year, or
   2. status-post surgical sterilization, or
   3. if of childbearing potential, utilization of adequate birth control and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day.
3. Metabolic Syndrome as defined by the presence of \> 3 of the following:

   1. Systolic Blood Pressure \> 130 mm Hg OR Diastolic Blood Pressure \> 85 mm Hg.
   2. Glucose Intolerance (Fasting Plasma Glucose ≥ 100 mg/dL)
   3. Increased triglyceride level \> 150mg/dL (1.7mmol/L)
   4. Decreased levels of HDL cholesterol (For males, less than 40 mg/dL; For females, less than 50 mg/dL)
   5. Waist circumference (For males, greater than 40 inches; For females, greater than 35 inches)

Exclusion Criteria:

1. type 1 Diabetes
2. Type II Diabetes
3. Impaired renal function
4. Prior allergies to medications used in the study protocol
5. Screening plasma potassium \>5.5 mmol/L or sodium \<135 mmol/L
6. Cardiovascular disease
7. Use of hormone replacement therapy
8. Breast-feeding
9. Treatment with anticoagulants
10. History of serious neurologic disease
11. History or presence of immunological or hematological disorders
12. Diagnosis of asthma requiring use of inhaled beta agonist
13. Clinically significant gastrointestinal impairment
14. Impaired hepatic function
15. Hematocrit \<35%
16. Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult, such as arthritis treated with non-steroidal antiinflammatory drugs
17. Treatment with chronic systemic glucocorticoid therapy
18. Treatment with lithium salts
19. History of alcohol or drug abuse
20. Treatment with any investigational drug in the 1 month preceding
21. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
22. Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section

Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.

Carbohydrate (sugar-containing) nutritional supplements have become a routine part of the package of care for people undergoing planned surgical procedures. the investigator wanted to discover whether carbohydrate supplements are a useful part of care packages used by doctors to improve recovery after planned cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women undergoing elective caesarean section
* Term gestational age (37+0 to 41+6 weeks)
* Singleton gestation

Exclusion Criteria:

* Women with gestational diabetes and diabetes mellitus
* Fetal intrauterine growth restriction
* Ante-natally detected congenital anomaly which will require admission to the neonatal nursery
* Women who received steroids within the past 7 days prior to delivery
* Women who did not complete a gestational diabetes screening test
Fasting Mimicking Diet With Chemotherapy in Patients With Leukemia

The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia.

The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia

Eligibility Criteria:
Inclusion Criteria:

* People who have recently been diagnosed with acute leukemia pathology and have been prescribed chemotherapy

  * Willingness to cooperate
  * BMI \>18.5

Exclusion Criteria:

* diabetes
* metastases to other organ
* Unwillingness to continue the study by patients
Lidocaine Versus Magnesium Sulphate in Management of Myofascial Pain Dysfunction Syndrome

The goal of this clinical trial is to investigate the effectiveness of Magnesium Sulphate in the management of myofascial pain dysfunction syndrome in comparison to Lidocaine and Saline.

A total of 75 patients suffering from myofascial pain dysfunction syndrome will be assigned into one of three groups, each with 25 patients.

Group A: (Saline) includes patients enrolled for Saline injection into the trigger points. Group B: (Magnesium Sulphate) includes patients enrolled for Magnesium Sulphate injection into the trigger points. Group C: (Lidocaine) includes patients who will be enrolled for Lidocaine injection into the trigger points The primary outcome that will be investigated is (pain with a visual analogue score), and secondary outcomes will be (maximum mouth opening between edges of upper and lower incisors with millimeters, electrical activity with Electromyography, and quality of life assessed using the Oral Health Impact Profile questionnaire) The outcomes will be assessed pre-injection, 1month after injection, 3months after injection, and 6 months after injection


Eligibility Criteria:
Inclusion Criteria:

* Age Limitations: Participants must be between 18 and 55 years old.
* Chronic Pain Diagnosis: Individuals must have a diagnosis of chronic myofascial pain dysfunction syndrome (MPDS) affecting the face muscles, neck, shoulder, or upper back for a duration exceeding three months.
* Trigger Point Recognition: Patients must show awareness of their pain when pressure is applied to identified myofascial trigger points, in accordance with established diagnostic guidelines.
* Consent to Participate: Willingness to provide informed consent and engage in all aspects of the study.

Exclusion Criteria:

* Previous Treatments: A history of receiving dry needling or pulsed radiofrequency therapy, or currently participating in other pain management treatments.
* Recent Injury or Surgery: Any recent trauma, surgical procedures, or infections in the affected area within the past six months.
* Medication Interference: Current or recent use of moderate to strong analgesics (e.g., tramadol, morphine) that could influence pain assessment.
* Severe Health Conditions: Individuals with significant systemic illnesses (e.g., severe liver or kidney disease), blood clotting disorders, rheumatoid arthritis or epilepsy.
* Mental Health: Presence of current psychiatric disorders, cognitive impairments, or inability to comply with the study protocol.
Electrophysiological-based Estimation of Cochlear Implant Fitting

The primary objective of this research is to evaluate the relationships between multiple data from cochlear implant (CI) adult users to and to estimate predictive models of their fitting parameters. In a group of patients, the Electrically-evoked Compound Action Potentials (ECAP) will be collected intra-operatively and the correlation with demographic data (deafness duration, age deafness onset, etiology, duration of cochlear implant use of CI), auditory performances and subjective measures used for implant fitting (hearing threshold and most comfortable level) will be calculated. In a second group of experienced users (more than 9months of use of their CI), ECAP and Electrically-evoked Auditory Brainstem Response (EABR) will be collected after 9 months of CI experience and after 12 months or more of use. Correlation analyzes with demographic data, performance and fitting parameters will be performed as well. Statistical predictive models for both fitting at the activation or in experienced users should be developed according to the correlation analysis.

The secondary objective is to evaluate the effects of simultaneous stimulation on hearing performances. Simultaneous stimulations will be delivered in one ear (bimodal condition) in patients using an Electro-Acoustic Stimulation device (EAS) or in the two ears (binaural condition) for bilateral CI users. ECAP, EABR and speech perception will be measured and compared in the different conditions.


Eligibility Criteria:
Inclusion Criteria:

* Good general health status including no neuropsychological diseases affecting intellectual capacities
* Users of cochlear implant or electro-acoustic stimulation devices
* Normal otoscopy
* No excessive sound exposure within 48h before the measure

Exclusion Criteria:

* For women, possibility of pregnancy (absence of effective contraception or confirmed menopause);
* Concomitant use of ototoxic or psychotropic treatment with anxiolytic and / or antipsychotic
Efficacy/Safety Study of Glimepiride to Type 2 Diabetes Patients Based on Metformin And Basal Insulin Treatment

All the guidelines suggest that metformin as the basis of type 2 diabetes medication, and evidence is sufficient.At the same time the basal insulin injection once a day are more and more widely used in diabetes patients in China.

This study aims to evaluate the efficacy and safety of adding glimepiride to type 2 diabetes patients with inadequate glycemic control with combined therapy of metformin and basal insulin.


Eligibility Criteria:
Inclusion Criteria:

* Understand the whole test process, voluntary and signed informed consent form
* Men and women aged 35 to 70 years old
* 20≤BMI\<35 Kg/m2
* Diagnosed with type 2 diabetes
* Undergoing metformin(Dose not less than 1000 mg/day)in combination with basal insulin injection once a day
* HbA1c7.0-11%
* Patients should be able to self blood glucose monitoring

Exclusion Criteria:

* sulfonylureas,glinides,TZDs use within 3 months before the study
* Pregnant or lactating women
* A history of ketoacidosis
* Allergy to sulfonylureas or sulfa drug patients
* Apparent dysfunction of liver and kidney patients(ALT\>2 times upper normal limit,serum creatinine\>1.2 times upper normal limit)
* Poor blood pressure control(systolic pressure\>180mmHg or diastolic blood pressure\>110mmHg)
* heart disease,cardiac insufficiency,unstable angina pectoris,ECG indicates left ventricle hypertrophy,severe anemia(Hb\<9.0g/d1)
* Severe diabetic nerve complications(ulcer of lower limb,neurogenic bladder)
* BMI\<20 orBMI≥35kg/m2
* Alcohol or drug abuse ,or can't collaborate due to mental disorder
* Digestion and absorption function obstacle or Other endocrine disorders
* Other chronic diseases required long-term glucocorticoid treatment
Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters

The purpose of this study is to compare the efficacy of 4 mm irrigated catheters with 2 mm irrigated catheters for ablation of typical flutter.It's a prospective randomised multicenter study.


Eligibility Criteria:
Inclusion Criteria:

* All patients above the age 18 years undergoing a first catheter ablation for typical atrial flutter

Exclusion Criteria:

* Pregnancy
* Hemodynamic instability
* A recurrence of previous ablated typical atrial flutter
Effects of Bread Gluten Content on Gastrointestinal Volumes

The investigators will apply non invasive Magnetic Resonance Imaging (MRI) techniques developed in Nottingham to evaluate the gastric emptying, small bowel water content, colonic gas and volumes in healthy volunteers eating three breads with different amount of gluten (none, normal, or high gluten) in three consecutive weeks.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-55
* Able to give informed consent

Exclusion Criteria:

* Unable to abstain from smoking for the duration of the study
* Pregnancy declared by candidate
* History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to: Inflammatory Bowel Disease, Coeliac Disease, Pancreatitis, Gallstone disease (biliary colic, cholecystitis), Diverticulitis, Cancer of the gastrointestinal tract, Irritable Bowel Syndrome
* Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder
* Any medical condition making participation potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner
* Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
* Reported alcohol dependence
* Taking any drug known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test. (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)
* Antibiotic or probiotic treatment in the past 4 weeks
* Inability to lie flat or exceed scanner limits of weight \<120kg
* Poor understanding of English language
* Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 0600
* Strenuous exercise greater than 10 hours per week (i.e. no competition training the week prior to the study).
* Participation in any medical trials for the past 3 months
* Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse
Combined Glucocorticoid Adrenergic Therapy For Wheezy Preschool Children

The investigators goal is to conduct a pilot randomized controlled trial (RCT) whose purpose is to determine the feasibility of a randomized trial designed to determine if either inhaled beclomethasone or a combination of inhaled beclomethasone/salbutamol (Clenil Compositum) are superior to placebo in treating pre-school aged children with an acute wheezing episode.


Eligibility Criteria:
Inclusion Criteria:

1. children 12-60 months of age
2. wheeze on auscultation
3. mild respiratory distress as measured by a score of \< 3 on the Pediatric Respiratory Assessment Measure (PRAM)
4. discharged home after evaluation by their ED physician.

Exclusion Criteria:

1. treatment with oral or parenteral corticosteroids in the last 14 days
2. treatment with more than 2 doses of inhaled corticosteroids in the previous seven days
3. presence of a severe co-morbidity such as bronchopulmonary dysplasia, cystic fibrosis, congenital heart disease, adrenal disorder or immune deficiency
4. previously enrolled into this study or concurrently enrolled in another intervention trial
5. lack of telephone access or presence of a significant language barrier
Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler

To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler mixed with lidocaine.

To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler mixed with lidocaine in one nasolabial fold compared to Radiesse® Injectable Dermal Filler without lidocaine in the contralateral nasolabial fold.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age.
* Is a candidate for nasolabial fold treatment using Radiesse.
* Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month.
* Understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.
* Has approximately symmetrical nasolabial folds.

Exclusion Criteria:

* Has received any type of treatment or procedures including surgery in the nasolabial folds.
* Has received neurotoxins in the lower half of the face in the past 6 months.
* Has received hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 1 ½ years.
* Has received polylactic acid, polymethyl methacrylate (PMMA), silicone or any other permanent filler in the lower half of the face.
* Has nasolabial folds that are too severe to be corrected in one treatment session.
* Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study.
* Has a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding.
* Is female and of child bearing potential and is pregnant or not using acceptable method of birth control.
* Has had any history of hypersensitivity to Lidocaine or anesthetics of the amide type.
* Has a history of anaphylaxis or multiple severe allergies.
* Has received any investigational product within 30 days prior to study enrollment or is planning to participate in another investigation during the course of this study.
Comparison of Different Screening Score for Hypoxemic OSA (Obstructive Sleep Apnea) With the Results of a Polysomnography (PSG)

Comparison of different screening score for hypoxemic OSA (Obstructive Sleep Apnea) with the results of a polysomnography (PSG). The different screening score studied are: STOP-BANG, DES-OSA, P-SAP and OSA50.

The investigators should compare the four screening scores (STOP-BANG, DES-OSA, P-SAP and OSA50) with the results of the PSG (and in particular the number of apnea and hypopnea index and the probability of hypoxemia).

Eligibility Criteria:
Inclusion Criteria:

* Adults patients (\> 18 years)

Exclusion Criteria:

* None