cyrilzakka/clinical-trials huggingface dataset:
The Feasibility and Advantages of Painless Indwelling Catheter in Uniportal VATS Lobectomy of Lung Cancer

This study is a prospective cohort study.The main study content is the feasibility and advantages of painless indwelling catheter in perioperative period of uniportal video-assisted thoracoscopic surgery in lobectomy of lung cancer,divided into exposed and non-exposed groups.The exposed group was painless indwelled urethral catheter, the non-exposed group was indwelled urethral catheter routinely.

This study is a prospective cohort study.The main study content is the feasibility and advantages of painless indwelling catheter in perioperative period of uniportal video-assisted thoracoscopic surgery in radical resection of lung cancer,divided into exposed and non-exposed groups,divided into exposed and non-exposed groups.Communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the exposed or non-exposed group.The exposed group was painless indwelled urethral catheter, the non-exposed group was indwelled urethral catheter routinely.By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the painless indwelling urethral catheters in lobectomy of lung cancer is more beneficial than the indwelled urethral catheter routinely in lobectomy of lung cancer, and it is safe and feasible.

Eligibility Criteria:
Inclusion Criteria:

1.18 to 75-year old patient with lung cancer who is eligible for Uniportal Video-assisted Thoracoscopic Surgery in lobectomy.

2.The result of rapid pathology is primary lung cancer.

3.Electrocardiogram, pulmonary function, color Doppler echocardiography, arteriovenous color Doppler ultrasound and other preoperative examination results are normal.

4.The patient agreed to participate in the study and signed the informed consent form.

Exclusion Criteria:

1. Patients have severe urinary system diseases (medium-to-severe BPH, urethral stricture, urinary calculi, infections, tumors, etc.) ,and/or have undergone abdominal and pelvic surgery before surgery.
2. There is a potential infection before surgery.
3. Heart and lung serious organic diseases.
4. Combined thoracic adhesions, patients with severe coagulation insufficiency.
5. The time of anesthesia is more than 4 hours.

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The Feasibility of Bilateral Intermediate Cervical Plexus Block for Thyroidectomy/Parathyroidectomy

The aim of this study was evaluated the feasibility of bilateral intermediate cervical plexus blockade to be anesthesia for simple thyroid/parathyroid surgery.

Bilateral intermediate cervical plexus blocks have been reported for thyroid/parathyroid surgery. This technique combined with intravenous sedation has used with safety in patients undergoing simple thyroid or parathyroid surgery. Simple surgery is defined as the thyroid conditions are not cancer, redo or substernal goiter.

Eligibility Criteria:
Inclusion Criteria:

* patient underwent thyroid/parathyroid surgery under nerve blocks and sedation

Exclusion Criteria:

* incomplete opioid consumption or pain score record.
Trends in Risk Factors for Mother-to-Child Transmission of Hepatitis C Among a Southern European Population

According to the centres taking part in the ALHICE survey, the number of HIV-HCV co-infected women is currently decreasing. This drop was first noted in 2006 and persisted in 2007. What might have been considered a chance phenomenon during the first year (2006) was confirmed in the beginning of 2008. In view of this information, the investigators wished to ascertain the reality of this trend and to investigate its causes, by attempting to answer the following questions: - Has the prevalence of risk factors for HCV infection changed among the general population over the past 10 years?

* Has the prevalence of risk factors for HCV infection changed among HIV/HCV co-infected women over the past 10 years?
* Is the change in the number of co-infected women who gave birth during the past 10 years related to the prevalence of certain risk factors among this population?
* Is the change in the number of co-infected women who gave birth during the past 10 years related to a decrease in certain risk factors for HCV infection among the general population?
* Have changes in addictive behaviour among women of child-bearing age played a role in the decreasing number of HCV-contaminated children? Furthermore, follow-up data from HCV-infected children born during this period will provide information concerning the course of HCV infection.

The objectives are to study trends in numbers of deliveries among HCV/HIV co-infected women as well as trends in risk factors for HCV infection among women of child bearing age and lastly to create a cohort of HCV infected children.

Materials and Methods:

This multi-centre epidemiological study (CHU Nice, CHU Toulouse, CHU Montpellier, H Clinic Barcelona, H Mar Barcelona) consists in two parts. Our study does not interfere with the usual management of mother and child as laboratory data (virology, immunology, and liver function) are already included in the medical files. Data collection will be conducted via an anonymous questionnaire by an only one clinical research assistant who will travel to each participating centre. These data are contained in the mother's and child's medical files. The data concerning the socio-demographic characteristics of mother, the characteristics of HIV and HCV infection with special attention for infection risk factors, and the circumstances of the delivery. The questionnaire among children include laboratory results at birth, M6, and M12, as well as assessment of hepatic fibrosis.

Data were analysed using SPSS software. Qualitative variables were tested by Chi-square and Fisher's exact test. For quantitative variables, the non-parametric Mann-Whitney test was used (median, 25th and 75th quartile). A p-value inferior than 0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Infected HIV/HCV pregnant women
* All women to give birth in 1 randomized week each 6 months
Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg

The purpose of this study to collect information on the safety, especially serious infections and malignancies, and efficacy of the long-term use of ORENCIA Intravenous Infusion 250mg in patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are beginning to receive the treatment with ORENCIA Intravenous Infusion 250mg under the approved indications, dosage, and administration
* Have available HAQ data
* Have available DAS28-ESR or DAS28- CRP data
* Have no past or present history of malignancies
* Are expected to be followed up for 3 years
Prediction of Lymph Node Invasion for Prostate Adenocarcinoma

Despite lymph node involvement (LNI) being one of the main prognostic factors in patients with prostate cancer (PCa), pelvic lymph node irradiation remains debated, possibly due to an insufficient selection of patients. Significant advances in LNI risk modelling have been achieved with the addition of visual interpretation of magnetic resonance imaging (MRI) data, but it is likely that quantitative analysis could further improve prediction models. In this study, the investigators aimed to develop and internally validate a novel LNI risk prediction model based on radiomic features extracted from pre-operative multimodal MRI.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the prostate treated by prostatectomy with extensive lymph node dissection
* Available pre-operative +/- PET choline

Exclusion Criteria:

* Unanalyzable pre-operative MRI
A Long-term Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis

Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.


Eligibility Criteria:
Inclusion Criteria:

* Provided signed, written informed consent.
* Has a positive result from a Type I allergy test.
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
* Presence of any abnormality or significant illness that could be expected to interfere with the study.
Feasibility of Visual Field Testing With a Virtual Reality Headset

This study aim to determine the feasibility of using a virtual reality (VR) headset (HTC Vive) to test the visual field. The VR headset test will be compared to a conventional visual field test, using the Humphrey Field Analyzer. The investigators will include 10 healthy patients without visual field defect, 10 patients with early glaucomatous visual field defect, and 10 patients with advanced visual field defect. Each patient will perform the conventional test twice and the VR headset test 4 times, divided in 3 visits within a 2 month period. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and VR tests will be similar.


Eligibility Criteria:
Inclusion Criteria:

* Previous visual field test with Humphrey Field Analyzer indicating normal field, early glaucomatous field damage, or advanced glaucomatous field damage, according to Canadian Glaucoma Society Guidelines.
* Ability to understand and consent to the study.

Exclusion Criteria:

* Presence of non-glaucomatous pathology that could influence the visual field test, such as media opacities.
* Previous intraocular surgery less than 6 months from inclusion.
* Difficulty to execute a reliable visual field test.
* Potential contra-indications to use of virtual reality headset, including: anxiety disorder, pregnancy, seizure disorder, cardiac pacemaker or other implantable device, severe vertigo or balance disturbance.
A Study of [¹⁴C]-LY3202626 in Healthy Male Participants

The purpose of this study is to measure how much of the specially prepared study drug, LY3202626, containing radiolabeled carbon \[¹⁴C\] gets into the blood stream and how long it takes the body to get rid of it.

Information about any side effects that may occur will also be collected.

Participants will stay at a clinical research unit (CRU). The study will last about 28 days (check in to follow-up) for each participant.

This study is for research purposes only and is not intended to treat any medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males, as determined by physical examination, clinical laboratory tests, medical history and electrocardiogram (ECG)
* Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive at screening

Exclusion Criteria:

* Have participated in a \[¹⁴C\]-study within the last 6 months prior to admission for this study
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
* Have a history of constipation or have had acute constipation within 3 weeks prior to admission
* Are currently or have been smokers or users of tobacco or nicotine replacement products within the 3 months prior to admission and/or have positive cotinine at screening or check-in
* Exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (e.g., serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
Ibuprofen Suspension Bioequivalence Study

The purpose of this study was to determine the rate and extent of absorption of Ibuprofen suspension formulations.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have given written informed consent.
* Age: ≥18 years ≤50 years.
* Sex: Male or female subjects are eligible for entry.
* Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception,
* Female subject of non-child bearing potential with negative pregnancy test at the screening visit
* Male subject willing to use an effective method of contraception, unless anatomically sterile
* Status: Healthy subjects as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
* Healthy Subjects with a Body Mass Index (BMI) of ≥20 and ≤27 kg/m2

Exclusion Criteria:

* Pregnancy or lactating female subjects.
* A history of significant disease of any body system.
* Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
* A history of allergy or intolerance related to treatment with ibuprofen, aspirin or other Non-Steroidal Anti-inflammatory Drug,or the excipients of the formulations.
* A history of or active peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
* A history of frequent dyspepsia, e.g. heartburn or indigestion.
* A history of migraine.
* Current smokers and ex-smokers who have smoked within 6 months.
* A history of drug abuse (including alcohol).
* High consumption of stimulating drinks (caffeine intake per day above 300 mg).
* Those with positive drugs of abuse screen including alcohol on any occasion throughout the study.
* Ingestion of a prescribed drug at any time in the 14 days before dosing with study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers during the previous month (such as barbiturates, carbamazepine, erythromycin, phenytoin, etc.).
* Ingestion of an over-the-counter preparation within 7 days before dosing with study medication.
* Donation of blood in quantity in the previous 12 weeks before enrolment into the study.
* Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.
* Topical use of ibuprofen within 7 days before dosing with study medication.
* Those previously randomised into this study.
* Employee at study site.
* Partner or first degree relative of the Investigator.
* Those who have participated in a clinical trial in the previous 12 weeks.
* Those unable in the opinion of the Investigator to comply fully with the study requirements.
Epileptic Seizure in Epilepsy Patients After SARS-CoV-2 Vaccination

Background and Objectives: Seizure attack is one of adverse effects of vaccination in epileptic patients, the risk of which after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inoculation was elucidated in the present study.

Methods: A self-controlled case series study was designed to examine the association between vaccination and epileptic seizure. A total of 240 epilepsy patients were included who were vaccinated with inactive SARS-CoV-2 vaccines (Sinovac Life Sciences and Lanzhou Institute of Biological Products) and admitted to outpatient clinics from July 2021 to December 2021. Poisson analysis was performed to estimate the relative incidence rate of epileptic seizure in risk periods (day 1-7, 8-21 and 1-21 after first-dose vaccination) compared to basal level in control period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants
* Have a diagnosis of epilepsy by the end of the study
* Have received at least one dose of inactive SARS-Cov-2 vaccine (Sinovac Life Sciences and Sinopharm Group)

Exclusion Criteria:

* Non-epilepsy patients vaccinated with inactive SARS-Cov-2 vaccine
* Epilepsy patients administrated with non-inactive vaccine
* Unvaccinated epilepsy patients
Retaining Short-term Training Effects on Gait Adaptability in People With Stroke

Background: The majority of stroke survivors regain walking ability. However, the ability to adapt gait patterns to meet environmental demands remains impaired in a majority of people in the chronic phase after stroke. This impaired gait adaptability has a profound impact on activities of daily living and quality of life. Treatment targeting gait adaptability is therefore critical for safe and independent community ambulation in people with stroke. Augmented or virtual reality in rehabilitation programs can be used to train gait adaptability in a controlled situation. A few studies have evaluated gait adaptability training in people with stroke. Although results were promising, these studies did not include an adaptability-related outcome measure, or were limited to uncontrolled or small-scaled pilot studies. Moreover, it is unknown if beneficial training effects can be fostered for 1 year after completion of a training program. We evaluate the short-term effects of a 5-week gait adaptability training in an adequately powered, waiting-list controlled clinical trial \[ref naar clin trial nummer\]. In the current study, we focus on the retention of potentially beneficial effects of this 5 week gait adaptability training program. We will evaluate if short-term effects of gait adaptability training can be retained through single training sessions to boost performance, or by an home exercise program. We hypothesize that booster sessions and home-based exercise will both yield better retention of training effects at 1 year follow-up as compared to the control arm without an experimental intervention.

Objective: The primary objective of this study is to test the hypothesis that retention of training-induced gains in gait adaptability can be fostered by providing booster sessions or by prescribing home-based training.

Study design: Explorative randomized study, comparing the effect of 3 1-hr booster training sessions against home-based exercise against no intervention on gait adaptability performance 1 year after completion of a 5-week gait adaptability training program.

Study population: Stroke patients in the chronic phase after stroke, who completed the 5-week gait adaptability training using the C-Mill and agreed to continue in this follow-up study. We expect this to be 50-75 participants.


Eligibility Criteria:
Inclusion Criteria:

* \> 6 months after first unilateral supratentorial stroke (chronic phase)
* Able to walk at least 10 minutes independently
* Initial involvement of the lower extremity after stroke.
* Having completed (minimal 8/10 training sessions) the 5 week gait adaptability training program using the C-Mill

Exclusion Criteria:

* Any other neurological or musculoskeletal disease affecting gait or balance (e.g. Parkinson's disease, knee osteoarthritis)
* Contractures or spasticity requiring other treatment (e.g. botulinum toxin treatment) within the duration of the training period.
* Severe cognitive or visuo-spatial impairments limiting comprehension of instructions or correct perception of the environments
Community Based Tobacco Cessation Programme Mumbai

The aim of this project was to provide tobacco cessation services to the women at the community level at their door steps and thus establish a model community based tobacco cessation programme which could be replicated in other communities and could be taken up by National Tobacco Control Programme (NTCP), in future.

The study was extended over a period of one year. There were 3 interventions given at the interval of 3 months each. The post intervention questionnaire regarding knowledge, attitude and practices was planned filled at the end of the programme i.e. 9th to 12th month from start of the programme. A community based tobacco cessation programme, which has the potential of being first of its kind, for women, was planned by the department of Preventive Oncology for the women in a geographical community in and around Mankhurd in Mumbai,for providing tobacco cessation counseling services. Doorstep services were provided to these women as they were unlikely to avail the tobacco cessation services at the clinic in TMH since their priority is managing household chores and caretaking of their family. The selected community was a part of women cancer screening programme namely; Tata Memorial Hospital Mobile Outreach Programme (TMH-MOP). The women who were current tobacco users at the time of screening under TMH-MOP were enrolled for this study.The women were intervened thrice at an interval of 3 months each and tobacco cessation counseling was provided at each intervention. The post intervention data was collected at the end of all the 3 counseling sessions. Sessions were held for rapport building with the participant women. Questionnaire were filled to record the information on the details of different forms of tobacco usage, factors responsible for initiation and continuation of tobacco use, pre-intervention and post-intervention knowledge, attitudes and practices regarding tobacco habits and severity of tobacco use (Fagerstroms scale). This programme was aimed at creating awareness and educating women regarding the health hazards of tobacco use, at the community level, at their door step.

Eligibility Criteria:
Inclusion Criteria:

all current tobacco users at the time of screening under TMH-MOP project

Exclusion Criteria:

All those who refused to participate and those who could not be contacted during the study period
The Synergy to Control Emergency Department Hyperglycemia Program for Type 2 Diabetes

A 4 week prospective, randomized controlled study was carried out to assess the impact of a care delivery intervention which focused on blood glucose (BG) management among adults with type 2 diabetes presenting to the Emergency Department (ED) with BG \> 200mg/dL (11.1 mmol/L). The intervention was designed by a multi-disciplinary team of ED physicians and nurses, endocrinologists and diabetes educators. The intervention incorporated three components: a guideline-based algorithm for diabetes medication management; survival skills diabetes self-management education (DSME); and support for health system navigation. The control group received usual care per the ED's policies and procedures for management of high blood glucose.

We evaluated a concise diabetes care delivery intervention designed to advance glycemic medications and deliver diabetes self-management education (DSME) among adults with type 2 diabetes presenting to the emergency department (ED) with uncontrolled hyperglycemia. The primary hypothesis was that there would be improvement in HbA1c.

A 4 week, randomized controlled trial provided algorithm-based antihyperglycemic medications management, survival skills DSME and navigation to primary care for ED patients with BG \> 200mg/dL. Medications were titrated and DSME delivered by endocrinologist-supervised certified diabetes educators. Controls received usual care.

Eligibility Criteria:
Inclusion Criteria:

* A new or existing diagnosis of type 2 diabetes;
* BG \> 200 mg/dl in the ED;
* age \>/= 18 years;
* willing and able to check BG and self-inject insulin, if required and otherwise stable for discharge to the outpatient setting.

Exclusion Criteria:

* type 1 diabetes and other specific types of diabetes per the American Diabetes Association Position Statement on the Classification of Diabetes Mellitus,
* pregnancy or anticipated conception in the next 3 months;
* treatment with a glucocorticoid, unless at a stable physiologic replacement dose; or
* a history of diabetic ketoacidosis.