cyrilzakka/clinical-trials huggingface dataset:
Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment

PROMPT aims at improving management of acute and chronic pain by identifying a core set of PROMs (patient reported outcome measures) that are predictive indicators of treatment success in clinical practice and controlled trials. These will not only address pain intensities as well as the functional consequences of pain for individuals but also identify patients at risk of experiencing chronification of acute post-operative pain. Results will help health care professionals to individualize pain management, and thus improve the quality of life of pain patients.

In order to reach this objective, a non-interventional prospective data collection aiming at reaching a consensus on a core set of PROMs which reliably predict and/or measure success in acute and chronic pain treatments in real life conditions and identifying predictors for chronification of postoperative pain will be conducted (PROMPT NIT-1). Aim of the data collection is to evaluate the abilities of certain PROMs in assessing acute post-surgical pain outcomes in daily routine care of patients after four different surgical procedures: (total knee replacement, breast surgery, sternotomy and surgery related to endometriosis), and to validate selected risk factors for chronification prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Patient is of consenting age (\>18 years old)
* Elective surgery
* Planned stay in hospital for the surgery
* First contact with the patient before surgery
* Patient agrees to participate

Exclusion Criteria:

* Patient is unable to give consent
* Cognitive impairment
* Questionnaire is not available in a language the patient is fluent in
* Patient not willing to answer the follow-up questionnaire
IPACK Nerve Block for Total Knee Arthroplasty

Double-blind, randomized controlled clinical trial to test the efficacy of IPACK on postoperative opioid consumption, patient satisfaction, pain scores, mobility, and several other secondary outcomes in adults undergoing primary unilateral TKA.

Enrolled patients will be randomized to either continuous ACB with IPACK or to continuous ACB with sham subcutaneous saline injection. Outcomes assessors and patients will be blinded to the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral, primary tricompartment total knee arthroplasty
* Age 18 years or older
* ASA I-III
* Eligible for spinal or combined spinal epidural anesthetic
* Able to speak, read, and understand English
* Willing to participate in the trial

Exclusion Criteria:

* Contraindication to regional anesthesia or peripheral nerve blocks
* Allergy to local anesthetics
* Allergy to NSAIDs
* Chronic renal insufficiency with Cr \> 1.4 or GFR \< 60
* Have chronic pain that is not related to their knee joint
* Have been using opioids on a chronic basis (daily or almost daily opioid use for 3 months or longer)
* Have a pre-existing peripheral neuropathy involving the operative site
* Body mass index greater than or equal to 40
The Feasibility and Effectiveness Study for Tele-ultrasonography

Purpose

- The investigators aim to evaluate the feasibility of remote interpretation for ultrasound images using a smartphone based realtime image transmission system.

Methods

A total of 100 echocardiography examinations; 50 showed the ejection fraction above 50% and remaining 50 cases showed the ejection fraction under 50%, and 100 abdominal ultrasound images; 50 had signs of acute appendicitis and the other 50 had no findings of appendicitis will be consecutively selected. The 12 raters review these original images using an LCD monitor of the ultrasound machine and also an iPhone which is connected to the ultrasound machine via remote image transmission system (CubeView, Alpinion medical system, Seoul, Korea), evaluating left ventricular systolic function (for echocardiography) by measuring the ejection fraction and grading the probability of presence of acute appendicitis on each examination by a five Likert scale.

The sensitivity and specificity between two devices will be compared and the diagnostic performance between two devices will be also compared. The image quality between two devices will be measured using the double stimulation impairment scale (DSIS)

The 12 raters are randomly divided into two groups

The raters in group one review the echocardiographies examinations numbered from one to 50 using LCD monitor of ultrasound machine and review the remaining 50 examinations numbered from 51 to 100 using iPhone with CubeView at their first visit The other group firstly review echocardiography numbered from one to 50 using iPhone with CubeView and 51 to 100 with the LCD monitor.

They visit twice with an interval of four weeks and review the echocardiography examinations using revered devices at each session. They also review abdominal ultrasound images on the same plan as reviewing echocardiography.

When they review the echocardiography, the raters measure the ejection fraction by visual estimation (1=obviously normal EF, 2 = probably normal EF, 3 = unsure, 4 = probably reduced EF, 5 = obviously reduced EF). In cate of d the abdominal ultrasound, they are instructed to rate the likelihood of the presence or absence of appendicitis in each case using a five-Likert scale (1 = obvious no appendicitis, 2 = unlikely appendicitis, 3 = unsure, 4 = likely appendicitis, 5 = obvious appendicitis).

Eligibility Criteria:
Inclusion Criteria:

* Board certified emergency physicians with a ultrasound experience of 4 years and over.

Exclusion Criteria:

* Corrected eyesight \< 20/30
* Color weakness or blindness
Changes in Invitro and ex Vivo Lens Metrology With Daily Wear Contact Lenses

The purpose of this study is to evaluate changes in contact lens geometry after lens wear

The purpose of this study is to evaluate changes invitro and ex vivo in contact lens geometry in daily lens wear

Eligibility Criteria:
Inclusion Criteria:

* • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;

  * Be at least 18 years old;
  * Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
  * Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses;
  * Has vision correctable to at least 6/12 (20/40) or better at distance in each eye with contact lenses;
  * Be experienced at wearing contact lenses.

Exclusion Criteria:

* • Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;

  * Any systemic disease that adversely affects ocular health
  * An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
  * Use of any topical ocular medication during trial with the exception of saline drops ;
  * Use of or a need for any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance
  * Eye surgery within 12 weeks immediately prior to enrolment for this trial;
  * Previous corneal refractive surgery;
  * Contraindications to contact lens wear;
  * Participated or currently enrolled in another clinical trial that may have affected vision or ocular physiology within the previous 2 weeks;
  * Be pregnant (formal testing of pregnancy is not required. A participant's verbal report is sufficient);
  * Worn soft contact lenses 2 calendar days or rigid gas permeable/ orthokeratology lenses 7 calendar days prior.
Coronary Microvascular Dysfunction in Chronic Kidney Disease

This is an observational study assessing coronary microvascular function in healthy controls with normal kidney function, living kidney donors, pre-dialysis patients with chronic kidney disease stage 5 and patients on peritoneal dialysis.

The clinical syndrome of uraemic cardiomyopathy is prevalent in end stage renal disease and is associated with pathological cardiovascular changes including left ventricular hypertrophy, diastolic dysfunction and diffuse interstitial fibrosis. These combine to confer an elevated cardiovascular risk, including an increased risk of sudden cardiac death.

The cause of this increased cardiovascular risk is not clear but it is thought that coronary microvascular dysfunction may play a role. Coronary microvascular dysfunction is prevalent in many myocardial disease states, such as hypertrophic cardiomyopathy and heart failure with preserved ejection fraction, that share pathological similarities with uraemic cardiomyopathy.

Coronary flow reserve, a marker of coronary microvascular function, can be assessed non-invasively using echocardiography techniques. Previous studies have shown a reduction in coronary flow reserve in patients with chronic kidney disease. However, it is not clear if kidney donors - individuals who have a reduced kidney function but do not have progressive kidney disease - also demonstrate microvascular dysfunction. Similarly, although there is some evidence that patients on dialysis have improved coronary flow reserve compared to patients with pre-dialysis chronic kidney disease stage 5, there has been limited investigation into the role of peritoneal dialysis on coronary flow reserve.

Eligibility Criteria:
Inclusion Criteria:

* Healthy control with normal renal function
* Living kidney donor who has donated \>12 months prior to enrolment in study
* Chronic kidney disease stage 5 who are pre-dialysis or on peritoneal dialysis
* Able to provide written informed consent

Exclusion Criteria:

* Pregnancy
* Known ischaemic heart disease
* Diabetes mellitus
* Uncontrolled hypertension
* Evidence of 2nd or 3rd degree AV block or sick sinus syndrome in absence of a pacemaker
* History of allergic/adverse reaction to adenosine or Sonovue
* History of long QT syndrome
* Severe hypotension
* Significant valvular heart disease
* Significant chronic obstructive pulmonary disease or asthma with bronchospasm
* Unstable angina not controlled with medication
* Concurrent use of dipyridamole
* Decompensated heart failure
* Poor echo acoustic windows
* Chronic kidney disease stage 5 on haemodialysis
Prospective Studies of the Pathogenesis of Schizophrenia

The purpose of this study is to use structural and functional magnetic resonance imaging (MRI) to study children at high risk for schizophrenia. It is hypothesized that children at high risk for schizophrenia will have abnormalities of brain development, especially of the cerebral cortex. The study will also describe normal brain development in children from birth to age 6 years

We are currently following enrolled children at 4 and 6 years of age. We are obtaining structural MRIs and rsfMRIs. In addition, we are assessing cognitive function and behavior with Stanford-Binet, BRIEF and BASC.

Eligibility Criteria:
Inclusion Criteria:

* control, offspring of mother with schizophrenia or bipolar illness; child with MVM

Exclusion Criteria:

* major neurological or medical illness
Prediction of Response to IUCD Associated Menorrhagia Using Doppler

Studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in women having IUCD associated menorrhagia


Eligibility Criteria:
Inclusion Criteria:

* women in chile bearing period (age 20-35 yrs ) with history of regular menstrual cycle presenting with recent onset of more then three months menorrhagia after IUCD "copper T 380 A" insertion

Exclusion Criteria:

* history of bleeding tendency
* history of abnormal uterine bleeding due to other causes
* history of active liver disease
* history of antiplatelet or anticoagulant intake in the last month
* history of thyroid disease
* history of endometritis
* history of allergy to NSAIDs
* Adenomyosis
* women having contraindications to use NSAIDs e.g. peptic ulcer
* Insulin dependant diabetes mellitus
SILS™ Port Laparoscopic Cholecystectomy Post Market Study

The objectives of this trial are:

1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy
2. monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC to objectively document the scientific merit and the perceived advantages of SILS™ Port Laparoscopic Cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 85 years old.
* Patient has a diagnosis of biliary colic with documented gallstones or polyps by imaging or Biliary dyskinesia with documented EF \< 30%.
* Body Mass Index (BMI) \< 45 kg/m2.

Exclusion Criteria:

* Any female patient, who is pregnant, suspected pregnant, or nursing.
* Any patient with acute calculus or acalculous cholecystitis.
* Any patient who has had an upper midline or right sub costal incision.
* Any patient with pre-operative indication for a cholangiogram.
* Any patient with ASA \> 3 with normal liver function.
* Any patient who is undergoing Peritoneal Dialysis (PD).
* Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair.
Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia

Cardiac output will be measured in healthy parturients undergoing cesarean delivery under spinal anesthesia

ASA-II women undergoing cesarean delivery under spinal anesthesia will be included. Cardiac output will be measured using transthoracic echocardiography at 4 time points: Baseline, after 10 minutes of intrathecal injection, after delivery, and after 1 hour of intrathecal injection. Spinal anesthesia will be administered with 2.5 ml bupivacaine 0.5% and fentanyl 15 μg.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status II parturients.
* Full term, singleton pregnancy
* Elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

* Height \<150 cm
* Weight \<60 kg
* Body mass index (BMI) \<18.5 or ≥ 35 kg/m²
* Women presenting in labor
* Contraindications to spinal anesthesia: increased intracranial pressure, coagulopathy, or local skin infection
* Hemoglobin \<10 g/dL
* Current administration of vasoactive drugs (e.g., salbutamol, thyroxin)
* Diabetes mellitus, cardiovascular, or renal disease
* Chronic or pregnancy-induced hypertension
* Polyhydramnios
* Women with high risk for postpartum hemorrhage or uterine atony (e.g., placenta accreta spectrum, ≥3 previous cesarean deliveries)
Closing the Loop in Adults With Type 1 Diabetes in the Home Setting

The main study objective is to compare real-time continuous subcutaneous glucose monitoring (CGM) combined with overnight automated closed-loop glucose control, and real-time CGM alone in the home setting.

Achievement of tight glycaemic control in type 1 diabetes mellitus (T1D) using intensive insulin regimens, which has been shown to be important for the prevention of long term diabetes-related complications, is limited by a significantly increased risk of hypoglycaemia. The average patient with T1D suffers two symptomatic episodes of hypoglycaemia per week, and one episode of severe hypoglycaemia, defined as an event requiring assistance of another person to administer rescue treatment in the form of carbohydrate and/or glucagon, per year.Despite the rapid advancements in insulin pump technology and the ongoing development of more physiological insulin preparations, the currently available therapeutic regimens are still unable to achieve optimal glycaemic control.The emergence of continuous glucose monitoring (CGM) over the last decade, which enables users to view in real-time estimates of plasma glucose and receive alarms for impending hypo- or hyperglycaemia, thus facilitating appropriate changes in insulin therapy, is a major step towards improved diabetes monitoring.

The desirable goal is the development of an insulin delivery that is glucose responsive and the development of effective real time glucose monitoring should allow this. Glucose responsive insulin delivery should allow achievement of ideal glucose targets with less risk of hypoglycaemia. Closed-loop systems may provide a realistic treatment option for people with T1D. The research we are conducting at the University of Cambridge has been focused on developing a closed-loop system for overnight glucose control in patients with T1D. The studies that have been performed so far employ model predictive control (MPC) - this algorithm estimates patient-specific parameters from CGM measurements taken every 1 to 15 minutes and makes predictions of glucose excursions, which are then used to calculate basal insulin infusion rates. We hypothesize that overnight automated closed-loop glucose control in the home setting will be efficacious and safe compared to CGM alone, in T1D subjects on insulin pump treatment.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative.
* On insulin pump therapy for at least 3 months

Exclusion Criteria:

* Non-type 1 diabetes mellitus
* Any physical/psychological disease likely to interfere with the study
* Taking medication likely to interfere with interpretation of the results
* Known/suspected allergy against insulin
* Patients with clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
* Ongoing severe recurrent hypoglycaemia as judged by the investigator.
Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in Subjects With Parkinson's Disease

This study investigates whether there is a change in 123iodine-2ß- carbomethoxy-3ß-(4-iodophenyl) tropane (\[123I\]ß-CIT) uptake after short-term treatment with levodopa compared to either dopamine agonist or placebo.

This is a multi-center, open-label study of short-term treatment with levodopa or cabergoline on striatal DATscan uptake in early Parkinson's disease. Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).

Eligibility Criteria:
Inclusion Criteria:

* The subject is aged 40 years or older.
* Written informed consent is obtained.
* Subjects have a clinical diagnosis of idiopathic Parkinson's disease.
* Hoehn and Yahr stages for subjects are I-II.

Exclusion Criteria:

* The subject has atypical or drug-induced Parkinson's disease.
* The subject has dementia.
* The subject has clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
* The subject is pregnant.
Comparison Between M-Pro and ProTaper Next

Comparing the postoperative pain resulting after mechanical instrumentation using M-pro files versus that resulting after using ProTaper Next rotary files in lower molar with symptomatic Irreversible pulpitis molars.

Lower molars with symptomatic Irreversible pulpitis molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using M-pro Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24, 48 and 72 hours post-operatively . After completing the treatment, patients will instructed to take placebo if they feel pain and will be asked to provide the quantity of placebo intake until 72 hrs. In case of pain not relieved by placebo, after recording the amount of pain, the patient will be instructed to take an alternative line of pain control (Ibuprofen 400mg tablets every 6 hours). The amount and frequency of Ibuprofen intake will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 1- Males or Females.
* 2- Mandibular molar teeth with:

  * Pre-operative sharp pain.
  * Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
  * Normal periapical radiographic appearance or slight widening in lamina dura using periapical index (PAI) score 1 as normal periapical structures or 2 as small changes in bone structures.

Exclusion Criteria:

* Patients having significant systemic disorders.
* Patients who are allergic to non-steroidal anti-inflammatory drugs.
* Patients with two or more adjacent teeth requiring root canal therapy.
* Teeth that have:

  * Necrotic pulp tissues.
  * Association with swelling or fistulous tract.
  * Acute or chronic peri-apical abscess.
  * Greater than grade I mobility.
  * Pocket depth greater than 5mm.
  * No possible restorability.
  * Previous endodontic treatment.
Pharmacogenetics of b2-Agonists in Asthma.

This study will help to find out if having a certain genetic makeup influences how a person with asthma responds to salmeterol, one of the two drugs in Advair(R).

Patients are being asked to take part in this research study because they have asthma. This clinical research study is being done to see if an asthmatic's gene make-up (DNA is made up of genes) affects the way they respond to a particular asthma medication called salmeterol. Certain genes make people tall or short. Certain genes give people brown or black hair. Similarly, certain genes may be associated with the way patients respond to asthma medications.

Salmeterol xinafoate (a long acting bronchodilator) and fluticasone propionate (an inhaled corticosteroid) are the medicines contained in Advair Diskus. During this study, patients with asthma will receive fluticasone inhaler (called Flovent) and Advair Diskus. The investigators want to find out if patients with asthma with certain genes respond in different ways to the salmeterol in Advair Diskus. The investigators also want to find out if patients with asthma with certain genes who are treated with salmeterol for two weeks have their airways open up less than usual when they use albuterol.

Eligibility Criteria:
Inclusion Criteria:

* Diplotype: Whites with specific diplotype and African Americans with specific diplotypes.
* Gender: Male or female. Women are eligible if they are not pregnant or lactating. Females subjects of childbearing potential will undergo a urine pregnancy test prior to each methacholine challenge test.
* Age: 10 years and older.
* Asthma Diagnosis: Physician diagnosed asthma according to American Thoracic Society criteria for at least 3 months.
* Asthma Therapy: There is no requirement for previous asthma therapy to be included in this study.
* Asthma Severity: forced expiratory volume in the first second (FEV1) must be \>= 60% of predicted normal values for age, height, and gender.
* methacholine challenge test provocative concentration (20% fall in FEV1) of \<=12\]mg/ml.

Exclusion Criteria:

* History of life-threatening asthma: Any episode of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures.
* Asthma instability: Hospitalization for asthma within 3 months of Visit 1.
* Concurrent respiratory disease: Any respiratory disease other than asthma.
* Sensitivities: Sensitivities to methacholine, Flovent® MDI, ipratropium bromide, albuterol, or Advair Diskus® that would put the safety of the subject at risk.
* Respiratory Tract Infection: Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks immediately preceding Visit 1, or for which antibiotic therapy has not been completed at least 2 weeks prior to Visit 1.
* Expected exposure to pollen allergen to which the patient is sensitive (by medical history of symptoms) during the 29 day study period. These patients can be studied when pollen exposure to which they are sensitive will not occur.