cyrilzakka/clinical-trials huggingface dataset:
The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights

Compression stockings have beneficial effects on the development of venous thromboembolic complications and oedema during long- haul flights. A randomized controlled trial investigating the effect of compression stockings during short-haul flights with a duration less than fur ours is lacking. Deep vein thrombosis is very rare on flights shorter than four hours, but compression stocking could have beneficial effects on other outcomes. The aim of this study is to assess if compression stockings used during a 3-3.5-hour flight will decrease leg edema and discomfort.

All participants will be adults who will undergo a 3-3.5 hours flight. Participants have received oral and written information about the trial. All compression stockings have a class two compression level (corresponding to 23-32 mmHg compression). Participants will be randomized to wear a compression stocking on one leg, while the other side acts as control. Within an hour preflight, the patient will measure ankle and calf circumference at marked circumferential areas on the leg and answer questionnaires regarding leg pain and subjective discomfort, whereafter the stocking will be put on, on the randomized side. Within one hour after the flight the stocking will be removed and patients will once again measure the ankle and calf circumference at the marked circumference and fill out the questionnaire.

Sample size: Mean difference in ankle circumference set to -0.19 cm. Standard deviation of the mean difference set to 0.3, 5% alfa and 80% power. Sample size with a paired design = at least 18 participants. However, for practical reasons we will include up to approximately 50 adults in the trial.

Withdrawal and dropout criteria: All participants can withdraw their consent at any point during the trial, without the need for explaining any reasons for withdrawal. Since compression stockings do not cause side effects, except for patients with severe arterial insufficiency in the legs, we do not expect the trial to be stopped due to complications. All withdrawals will be accounted for in the scientific publication.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants ≥ 18 years of both sexes. Otherwise no restriction, since each participant acts as their own control.

Exclusion Criteria:

* Any condition requiring compression stockings during short-haul flights. Severe arterial insufficiency in the lower extremities.
Enhancement of Sleep Quality and Mood Following Supplementation With Lemon Balm in an Adult Population (Lemslp)

This study aims to investigate the effect of a 4-week dietary intervention of 300mg encapsulated aqueous lemon balm extract on measures of sleep quality, mood and well-being, alongside relevant biomarkers of circadian rhythms in healthy adults aged 18-40 years with mild sleep problems (PSQI entry of 5 and above). Three visits to the university alongside completing some home tests involving self-test stool, saliva and mood tests and wearing an wrist-secured actiwatch over 4-weeks whilst recording a daily sleep diary will be monitored to estimate sleep changes. Mood ratings, stool and saliva biomarkers will serve as a proxy to sleep improvement.

A randomised, double-blind, placebo-controlled, parallel-design study assessing the effect of a 4-week intervention of lemon balm extract (or matched placebo) in young to middle-age adults with mild sleep problems. A total of 108 participants will be randomly assigned to either 300 mg lemon balm extract or a matched placebo capsule consumed nightly before retiring to bed. The severity of sleep problems, depression, anxiety, perceived stress, quality of life and well-being will be measured at baseline and after 4 weeks of daily consumption. In addition, we will assess changes in microbiota and saliva neurohormone profiles at baseline and after 4 weeks of treatment.

Entry to the study to determine eligibility involves a sleep quality questionnaire (PSQI) score of 5 and above. The study comprises of a familiarisation visit and then two test days at the Nutritional Psychology Unit based at the University of Reading where primary sleep (PSQI), and exploratory measures of sleep (ISI, LSEQ) and mood (PANAS, Vivascentz(TM), FFS, PSS, DASS-21) tests will be completed. The screening visit will further assess habitual diet (Epic-Norfolk FFQ), and general health and lifestyle patterns to confirm eligibility. Participants will then continuously wear an wrist-secured actiwatch whilst recording a daily sleep diary to estimate sleep changes over the 4-week period. In addition, some further exploratory tests will be completed by participants from home 24h before baseline and 24h before post-intervention (saliva, stool, PANAS-X).

Eligibility Criteria:
Inclusion Criteria:

* Healthy, between18-40 years old
* Mild Sleep problems (PSQI less than or equal to 5)
* Willingness to provide stool and saliva samples, wear an actiwatch and complete a nightly sleep diary.

Exclusion Criteria:

* Use medications that may affect the outcome
* Any long-term psychological or physiological health conditions
* Have any allergic reactions to ingredients in the capsules
* Have a BMI greater than or equal to 30
* Are vegetarian
* Taking any dietary supplements which they are unwilling to stop for the duration of the study
Prospective Comparison of Cold Polypectomy and Conventional Polypectomy for Small Colorectal Polyps in Patients Taking Antithrombotic Agents

1. Background: The ideal method to remove small colorectal polyps in patients who are taking antithrombotic agents is unknown.
2. Aim: The aim of this study is to evaluate postpolypectomy bleeding and the complete retrieval rate after the removal by colon snare transection without electrocautery for small polyps in patients who are taking antithrombotic agents.
3. Design: A prospective, consecutive study.
4. Setting: Municipal hospital outpatients.
5. Interventions: Polypectomy by cold snare technique (Cold polypectomy) was performed for colorectal polyps up to 10 mm in diameter in patients who continue to take antithrombotic agents. The primary outcome measure was bleeding within two weeks after polypectomy. Secondary outcome measure was the complete retrieval rate of colorectal polyps based on the pathological examination.


Eligibility Criteria:
Inclusion Criteria:

* Patients with colorectal polyps up to 10 mm in diameter. The patients continue to take antithrombotic agents.

Exclusion Criteria:

* patients are less than 20 years old,
* pregnant,
* American Society of Anesthesiologists class III and IV,
* overweight (body weight \> 100 kg), or
* allergic to propofol used or its components (soybeans or eggs),
* with previous colorectal surgical resection.
DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant

This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after cardiac transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor heart to an HCV naïve recipient.

Eligibility Criteria:
Inclusion Criteria:

* Recipient is Age ≥ 18 years
* Serum ALT within normal limits with no history of liver disease
* Lack of sensitization (i.e. PRA \< 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection

Exclusion Criteria:

* Sensitization (i.e. PRA \>20%)
* Any liver disease in recipient
* Albumin \< 3g/dl or platelet count \< 75 x 103/mL
* Need for dual organ transplant
The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion

This was a randomized controlled trial of 400 women who attended the outpatient clinic of Menoufia University Hospital for copper IUD insertion. The women were randomly assigned to cough and control groups.The primary outcome measure was the level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).

We conducted this randomized controlled trial at the Department of Obstetrics and Gynecology at Menoufia University Hospital, Egypt, from May 2018 to March 2020. Our hospital research ethics committee approved this study. We obtained informed consent from all participants before initiating any study procedures. CONSORT guidelines were observed and completed.

We recruited non pregnant women (aged 18-45 years) requesting copper T380A IUD insertion for contraception. Eligible women had no prior vaginal delivery or pregnancy termination beyond 12 weeks, gestation (as patulous cervical os may affect VAS score), any previous deliveries had been by cesarean section, they were immediately postmenstrual or 1 week after pregnancy termination and they were willing to complete the study questionnaires. All women had to be alert, oriented, and cooperative to respond easily to VAS.

Exclusion criteria were current pregnancy, prior vaginal delivery, history of cervical stenosis, current pelvic inflammatory disease, uterine anomalies, undiagnosed abnormal uterine bleeding, fibroids distorting the uterine cavity, and patients using chronic NSAIDs or on chronic pain medication.

We randomized participants in a 1:1 ratio to cough and control groups. A statistician not directly involved in the study prepared a computer generated randomization list and placed the allocation information in sequentially numbered sealed envelopes that were opened according to the attendance of the subjects after signing the informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Non pregnant women (aged 18-45 years) requesting copper T380A IUD insertion for contraception.
* No prior vaginal delivery or pregnancy termination beyond 12 weeks gestation (as patulous cervical os may affect VAS score).
* Any previous deliveries had been by cesarean section.
* Immediately postmenstrual or 1 week after pregnancy termination.
* They were willing to complete the study questionnaires.
* All women had to be alert, oriented, and cooperative to respond easily to VAS.

Exclusion criteria were:

* Current pregnancy.
* Prior vaginal delivery.
* History of cervical stenosis.
* Current pelvic inflammatory disease.
* Uterine anomalies.
* Undiagnosed abnormal uterine bleeding.
* Fibroids distorting the uterine cavity.
* Patients using chronic NSAIDs or on chronic pain medication. We randomized participants in a 1:1 ratio to cough and control groups. A statistician not directly involved in the study prepared a computer generated randomization list and placed the allocation information in sequentially numbered sealed envelopes that were opened according to the attendance of the subjects after signing the informed consent
Safety and Efficacy of Daily Use of Micamlo® Combination Tablets AP in Patients With Hypertension

Investigation of safety and efficacy of daily use of Micamlo Combination Tablets AP in patients with Hypertension


Eligibility Criteria:
Inclusion criteria:

- Male and Female patients with hypertension who did not receive of MICAMLO Combination Tablets AP before the start of the study

Exclusion criteria:

* Patients with a history of hypersensitivity to any ingredient of Micamlo Combination Tablets AP and dihydropyridine derivatives
* Pregnant woman or possibly pregnant woman
* Patients with extremely poor bile secretion or patients with serious hepatic disorder
Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)

To assess the safety and efficacy of CO2 insufflations during ERCP

1. Primary objective:

   To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group.
2. Secondary objective:

Endoscopist:

* To assess the adequacy of bowel distension for adequate luminal visualization
* To assess the peristaltic movement during the ERCP

Anesthetist:

* To measure the PCO2 level in patient post procedure.
* To assess the amount of sedation required during the procedure.
* To assess saturation and vital signs through out the procedure.
* To assess requirement of buscopan.

mentioned in complete

Eligibility Criteria:
Inclusion Criteria:

* All consecutive adult patients referred for ERCP to AIG Hyderabad

Exclusion Criteria:

* Age \< 18 years old excluded from the study.
* Patients with COPD.
* Patients with poor ejection fractions and decompensated heart failure.
* Patients with acute illness that require emergency ERCP and not fit for pre procedure and post procedure assessments.
* Patients with recent endoscopic procedure within 24 hours.
* Patient with history of recent surgery within 7 days of duration.
* Pregnant patients.
* Patients not keen to give consent for the study.
Comparative Performance of INVU™ Versus Intrauterine Pressure Catheter (IUPC) in Uterine Contractions Monitoring of Pregnant Women.

The primary objective of this research is to assess the agreement between INVU™ and IUPC (the gold standard) during prenatal monitoring of uterine contractions and to assess the safety of INVU™. Additional information comparing INVU™ to TOCO (the standard of care) was also collected.

This multi-center, prospective, comparative, open-label study will be performed in two steps: A training step where up to 40 subjects will be enrolled to confirm uterine contraction performance level.

In the second, validation step, the performance of the uterine contraction detection algorithm will be validated. The validation phase will involve up to 80 subjects.

Sub-study will be implemented in the sites that will monitor the uterine activity of the subjects with TOCO, in addition to INVU™ and IUPC.

Following the screening process, participants subject will undergo continuous recording of the uterine contraction and the fetal heart rate (FHR) for 30 to 60 min using INVU™, Cardiotocograph ((TOCO / CTG), and Intrauterine Pressure Catheters (IUPC). The collected data will be downloaded and comprehensive analysis of the values will be performed offline. Each participant will undergo continuous monitoring by the medical team to identify any safety issue, including but not limited to irritation, sensitization, and potential harmful misuse.

Eligibility Criteria:
Inclusion Criteria:

* Female age between 18-50
* Gestational age ≥32 + 0 weeks
* Singleton gestation
* Ability to understand and sign informed consent
* The subject is within the first stage labor, including early, active and transition phases (cervix is dilated up to 10 cm)
* The subject has an IUPC in place for clinical contraction monitoring
* Exclusion Criteria:
* BMI ≥50 and 15≤ prior pregnancy (Body Mass Index)
* Multiple gestation
* Uncontrolled Hypertension
* Known fetal Anomaly (i.e. major structural)
* Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.)
* Subjects with implanted electronic devices (pacemaker, defibrillator, etc.)
* Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study
* Subject who is within the second stage labor (cervix is fully dilated to 10 cm or going into the second stage of labor or more)
Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%

A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or older
2. Either gender
3. Any race/ethnicity
4. Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension

Exclusion Criteria:

1. Patients with any form of glaucoma other than open-angle glaucoma.
2. Patients with a central cornea thickness greater than 620 μm
3. Patients with Shaffer angle Grade \< 2
4. Patients with a cup/disc ratio greater than 0.80
5. Patients with severe central visual field loss
6. Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent)
7. Chronic, recurrent or severe inflammatory eye disease
8. Clinically significant or progressive retinal disease
9. Other ocular pathology
Dietary Nucleotides and Ribose on Muscle Fuel Utilisation

Nucleotides are the building blocks for a variety of molecules, including ATP, which is broken down in the skeletal muscle cells to provide fuel for exercise. Nucleotides can be obtained from the diet, and produced or salvaged by the body. Though nucleotides provide the building blocks for ATP, the sugar ribose has been suggested to be rate limiting for synthesising ATP.

Previous studies have shown a decrease in ATP levels in the muscle after intense exercise, and this is linked to fatigue. Other studies have also reported benefits of nucleotide and/or ribose supplementation on exercise performance. However, any potential link between ATP metabolism and exercise performance has not been explored.

This study will look at the effects of nucleotide and nucleotide-ribose supplementation in fuel utilisation and performance in skeletal muscle during endurance exercise.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18 and 30

Exclusion Criteria:

* On medication (except contraception)
* Smokers
* Diagnosed with any metabolic or cardiovascular conditions
* Muscle or bone injuries
* BMI \< 18 or \> 30
Randomized Controlled Trial of Open Stabilisation Versus TPS

Spread of cancer to the spinal column is a growing problem in patients with cancer. It can cause a number of problems including pain, instability and neurologic problems. If left untreated, progressive weakness, numbness and bladder/bowel disturbance occurs. The aim of treatment is to help with pain and to reduce the risk of these neurological problems. This treatment has traditionally been radiotherapy to the spine. Surgery has always meant large open operations with a long recovery time and significant risk of complications. There has been new technology that has allowed less invasive operations to take place to stabilise the spine. The aim is to relieve the pressure on the spinal cord in addition to stabilising the spinal cord. These techniques are called 'minimally invasive' and include surgical techniques such as cement augmentation and percutaneous instrumentation.

The aim of this study is to compare traditional open operations with these new minimally invasive techniques to see if they do result in reduced complications and quicker recovery in addition to achieving the goals of surgery.


Eligibility Criteria:
Inclusion Criteria:

* Has an age ≥ 18 years
* Is suitable for radiotherapy
* Has been assessed by the oncologist
* Has symptoms of pain
* Is diagnosed with metastatic spinal pain from MRI findings with or without biopsy
* Technically possible to perform the surgery
* Is willing and able to comply with required followup questionnaires
* Is able to understand the risks and benefits of participating in the study
* Understands and has signed the informed consent form.
* Life expectancy of \> 3 months

Exclusion Criteria:

* Active systemic infection or infection localized to the site of implantation
* Allergy or sensitivity to Polyether ether ketone (PEEK), Titanium or Tantalum
* A bleeding disorder precluding from invasive surgery
* Rapid neurological deterioration requiring urgent surgery which would be delayed to the detriment of the patient by including in this study
SAGES Safe Cholecystectomy Program in Polish Reality - Awareness, Implementation and Opinion on Usefulness

The study is designed to assess the awareness of the SAGES Safe Cholecystectomy Program among polish surgeons, as well as the degree of implementation of this Program during laparoscopic cholecystectomy performed in Poland. It also gathers the opinion of polish surgeons on usefulness of each of the SAGES Safe Cholecystectomy Rules

The study is based on an anonymous questionnaire that is distributed among polish surgeons across the country. The questionnaire focuses on the demographic data of the surgeon, their experience in years, a few questions regarding their experience in the field of cholecystectomy surgery and questions about whether or not they are familiar with the SAGES Safe Cholecystectomy Program, Teaching Program for the Culture of Safety in Cholecystectomy, as well as Updated Tokyo Guidelines for the management of acute cholangitis and cholecystitis. The questionnaire is available as an appendix. It is then followed by the list of all the Rules of SAGES Safe Cholecystectomy Program with questions about the usefulness of each of the rule, evaluated in form of a 10-point numeric scale (0 - completely useless, 9 - critical).

The collected data will be subject to statistical analysis, the result of which will form the base for creating the Polish Program for Safe Cholecystectomy that will serve to increase the safety of this very common surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* general surgery specialist or resident registered in Polish National Doctors' Registry
* filled questionnaire on SAGES Safe Cholecystectomy Program

Exclusion Criteria:

* questionnaire not filled properly, missing answers
* declaration of not being either general surgeon specialist of general surgery resident in Poland
The Evolution of Visual Acuity Measured by Electronic Tablet / Computer of Exudative AMD Patients

This pathology, DMLA, whose evolution is chronic, requires regular follow-up and care (IVTs) over a long period (several months or even years).

Increasing the number of patients to be followed and treated poses increasing problems for ophthalmologists to ensure regular follow-up of patients, followed by a need for satisfactory functional results.

Moreover, this regular follow-up imposes enormous constraints on patients and their families (some children or patients are still working).

Studies are beginning to emerge on the reliability of patient follow-up in telemedicine. The use of a measure of visual acuity by patients, Electronic Tablet (TE) or computer (O), and at home, seems a logical step to help us improve the quality of patient follow-up while spacing controls.

The aim of our study is thus to demonstrate that the measurement of the VA performed by TE or O is reliable. Indeed, during the follow-up of the patients, in the case where the patient's AV decreases, and whatever the reason

Our aim is to compare the evolution curves of the Visual Acuity (AV) measured in each patient on Electronic Tablet (TE)/ computer(O) and on the Early Treatment of Diabetic Retinopathy Study (ETDRS) scale, in order to check the reliability of the measurements performed by TE / O by comparing them with a well-known reference measure And is routinely practiced routinely in ophthalmology centers.

Measurement of visual acuity on TE / O will be carried out on an ETDRS AV scale, the size of the letters having been adapted to the reading distance (80 cm by 0.40 cm on the tablet). An ETDRS intermediate vision (EVI) or meadow vision (TEU) score according to the group will be established in the same way. The VA measurement will be supervised by a CRA trained to the extent of the VA, without the orthoptist or ophthalmologist being informed of the results obtained.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 50 years of age.
* Patient monitored and treated in the department by intravitreal injections of anti VEGF (aflibercept or ranibizumab) in the indication of treatment.
* Patient with exudative AMD
* Patient who consented to participate in the study
* Patient who is able to understand the study and use a TE / O
* Patient with AV greater than or equal to 20/100
* Patient affiliated to a health

Exclusion Criteria:

* Patient having expressed his / her refusal on the collection of the medical data of his file at the end of the study
* Patient treated with non-AMD pathology
* Patient with AV less than 20/100
* Vulnerable person: protected by the law: guardianship, curatorship.
* Person participating in another test