cyrilzakka/clinical-trials huggingface dataset:
Lobaplation or Cisplatin in Adjuvant Chemotherapy for Esophageal Carcinoma

The multicenter real-world and propensity score matching comparative study was designed to explore the toxicity and effectiveness of Lobaplation or Cisplatin based adjuvant chemotherapy in esophageal carcinoma

This trial is a multicenter real-world retrospective comparative study. The patients with thoracic esophageal squamous cell carcinoma, esophagectomy and adjuvant chemotherapy(Cisplatin plus Docetaxel or Lobaplatin plus Docetaxel) from 6 centers in China were enrolled from Jan.2013 to Dec.2016. Completed clinical and pathological data were collected from Large-scale Data Analysis Center of Cancer Precision Medicine-LinkDoc database and analyzed by using data technology support from LinkDoc by using R-language. A hybrid solution for extracting structured medical infromation from unstructured data in medical records via a double-reading/entry system. The World Health Organization (Toxicity Grading Scale for Determining the Severity of Adverse Events) was used. The side effects of adjuvant chemotherapy and overall survival rate were compared by a propensity score. The 6 centers are The affiliated Cancer Hospital of ZhengZhou university/Henan Cancer Hospital, Anyang Cancer Hospital, Anhui Province Hospital, The first affiliated Hospital of Anhui university, Tangdu Hospital/the affiliated Hospital of Fourth Military Medical University, The First Affiliated Hospital of Xi'an Jiao Tong University.

Eligibility Criteria:
Inclusion Criteria:

* i) thoracic ESCC stage II to III; ii) without any preoperation treatment for ESCC; iii) underwent R0 resection; iv) received ajuvant chemotherapy of Cisplatin plus Docetaxel or Lobaplatin plus Docetaxel.

Exclusion Criteria:

* i) with ajuvant radiotherapy/chemoradiotherapy; ii) history of other type of cancer iii) without completed clinical, pathological and follow up data.
Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis

Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.

This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational sites in the United States.

This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging from one packet 12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles, depending upon treatment success and AK lesion recurrence. Eligible subjects applied imiquimod 5% cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical, visible, discrete, nonhypertrophic AK lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline. Multiple treatment areas could be exposed (i.e., head, torso and/or extremities), with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area, up to a maximum of 6 packets per dose. In each treatment cycle, dosing was to continue for 16 weeks (approximately 4 months), as instructed by the investigator, followed by a 2-month, treatment-free follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years of age.
* Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic keratosis lesions.

Exclusion Criteria:

* Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).
* Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.
Interaction Between Tramadol and Ondansetron

In the postoperative period; pain, nausea, and vomiting are undesirable side effects that reduce the patient's comfort and may lead to various complications. Ondansetron is frequently used as an antiemetic and tramadol hydrochloride is used for postoperative analgesia in laparoscopic cholecystectomy. However, some studies have reported that there is a drug interaction between these two drugs and they reduce each other's effects, thus requiring more analgesics in the postoperative period.

The aim of this study is; To evaluate whether ondansetron reduces the analgesic efficacy of tramadol hydrochloride in laparoscopic cholecystectomies.

During the operation, 4 mg iv ondansetron (2mL) will be administered to the ondansetron group and 2mL iv 09% saline will be administered to the placebo group. The patients' heart rate, blood pressure, oxygen saturation, sedation score (with Ramsey Seading Score), amount of pain (with NRS), degree of nausea (with NRS), whether there is vomiting, whether analgesic or antiemetic treatment is required, and the amount of tramadol use will be recorded at 1, 2, 4, 8, 12 and 24 hours in the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

60 patients over the age of 18, ASA I-II, undergoing laparoscopic cholecystectomy

Exclusion Criteria:

1. Patients under 18 years of age
2. Patients with known allergies to the drugs to be used
3. Pregnant and breastfeeding mothers
4. Patients who received antiemetic or cortisone within 24 hours before surgery
5. Patients with mental illness or epilepsy
6. Patients with alcohol or substance abuse
Study Comparing Corpus Callosum Atrophy as a Marker of Later Development of Cognitive Impairment in Patients With Multiple Sclerosis

This study is a cross sectional study of patients diagnosed with clinically isolated syndrome (CIS) and RRMS, who will undergo a series of tests to assess cognitive impairment, fatigue severity and depressive symptoms. Cognitive impairment will be assessed with Multiple Sclerosis Inventory Cognition (MUSIC) and symbol digit modalities test (SDMT), fatigue severity will be measured with the Fatigue Scale for Motor and Cognitive Functions (FSMC) and depressive symptoms with the Beck Depression Inventory (BDI). All tests mentioned above are validated for MS patients. In the second step we will use our large longitudinal database of serial MRI examinations from which a linear measurement of CCI will be retrospectively calculated.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 55 years at presentation
* Diagnosis of relapsing-remitting MS according to revised McDonald criteria 2005, clinically isolated syndrome suggestive of MS
* Patients treated with interferon-beta 1b
* Untreated patients
* EDSS under 5.5

Exclusion Criteria:

* Brain pathology other than MS
* Known history of head trauma
* Pure spinal manifestation of demyelization
* Neuromyelitis optica
* Primary and secondary progressive MS
* Benzodiazepine intake within the last three months
* Relapse within the last three months
* Steroid intake within the last three months
* History of severe depressive disorder and/or suicidality, seizure, drug or alcohol abuse
* No informed consent
* Insufficient knowledge of German
MultiMorbidity Life-Course Approach To Myocardial Health -A Cardiac Sub-Study of the MRC National Survey of Health and Development (NSHD)

Background The life course accumulation of overt and subclinical myocardial dysfunction contributes to older age mortality, frailty, disability and loss of independence. The Medical Research Council National Survey of Health and Development (NSHD) is the world's longest running continued surveillance birth cohort providing a unique opportunity to understand life course determinants of myocardial dysfunction as part of MyoFit46-the cardiac sub-study of the NSHD.

Methods and expected results The investigators aim to recruit 550 NSHD participants of approximately 75 years+ to undertake high-density surface electrocardiographic imaging (ECGI) and stress perfusion cardiovascular magnetic resonance (CMR). Through comprehensive myocardial tissue characterization and 4-dimensional flow the investigators hope to better understand the burden of clinical and subclinical cardiovascular disease. Supercomputers will be used to combine the multi-scale ECGI and CMR datasets per participant. Rarely available, prospectively collected whole-of-life data on exposures, traditional risk factors and multimorbidity will be studied to identify risk trajectories, critical change periods, mediators and cumulative impacts on the myocardium.

Conclusion By combining well curated, prospectively acquired longitudinal data of the NSHD with novel CMR-ECGI data and sharing these results and associated pipelines with the CMR community, MyoFit46 seeks to transform our understanding of how early, mid and later-life risk factor trajectories interact to determine the state of cardiovascular health in older age.


Eligibility Criteria:
Inclusion Criteria:

* NSHD study member.
* Who is still alive and agreed to take part in the study.

Exclusion Criteria:

* Pacemaker.
* Implantable cardio defibrillator.
* Atrial fibrillation.
* Complete heart block.
* Severe asthma.
The Effect of Kinesiotaping on Sprint and Dynamic Balance in Children

The aim of this study is to examine the acute effects of kinesio taping applied to the gastrocnemius muscles of children enrolled in soccer school on sprint and dynamic balance.Children who meet the required criteria will be randomly placed in the kinesio taping and placebo groups by drawing lots. Dynamic balance and sprint abilities of the participants were evaluated before and immediately after taping. Y Balance Test will be used to evaluate dynamic balance. Measurements were taken in the anterior, posteromedial and posterolateral directions of the right and left sides.10 m and 20 m sprint tests will be used to assess speed ability. In-group and between-group comparisons will be analyzed using the Statistical Package for the Social Sciences program and appropriate tests.


Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 8-12
* To be actively participating in football training.

Exclusion Criteria:

* Those with orthopedic, neurological and congenital problems.
* Those with any systematic disease.
* Those who have experience taping before.
* Those who have undergone any surgery within the last 1 year.
* Those who have been absent from training for more than 2 weeks in the last three months.
A Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)

The purpose of this study it to conduct a randomized, controlled, double-blinded trial of carbon dioxide (CO2) versus air insufflation during endoscopic retrograde cholangiopancreatography (ERCP).


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years
* referred for ERCP for any indication at UNC Hospitals

Exclusion Criteria:

* age \< 18 years
* COPD requiring oxygen or with known CO2 retention
* any medical condition with known CO2 retention
* medical instability making the procedure unsafe
* absolute requirement for same-day second endoscopy
* ERCP performed in the OR or under GA
* inability to read or understand English
* use of chronic opiates for pain
* pregnant women
Mechanism of Growth Hormone Effects on Adipose Tissue

Growth hormone treatment in humans has been shown to decrease body fat. This study aims to determine what adipose tissue depots are affected by GH and what is the mechanism.

Growth hormone (GH) replacement in GH deficient adults results in an improvement in metabolic status, an increase in lean body mass and a reduction in visceral adiposity. GH might also decrease visceral adiposity in obese adults that are not GH deficient.

The objective of the study is to determine the effects of GH on the metabolic syndrome and visceral adiposity in men with low blood levels of IGF-1 and the durability of these effects after stopping GH therapy. We will use a double blind, placebo controlled 6 month intervention trial followed by a blinded follow-up period of 6 months. Thirty non-diabetic middle aged men with central adiposity (BMI \> 27 kg/m2, waist circumference \> 102 cm) will participate.

Eligibility Criteria:
Inclusion Criteria:

* Male, aged 40-70
* Central obesity defined as waist circumference greater than 102 cm and BMI \> 27 and \< 35 kg/m2
* No weight loss in last 12 months
* Total IGF-1 level \< 241 ng/ml (\~25th percentile for the assay)
* Body habitus which permitted accurate CT scan acquisition and analysis.

Exclusion Criteria:

* Significant neurologic, metabolic, endocrine, cardiac, respiratory or gastrointestinal disease
* Diabetes
* Known coronary heart disease
* Exercised more than 3 hours per week
* Unwilling or unable to abstain from alcohol for 72 hours prior to the measurements of energy expenditure and fasting blood work
Evaluation of the Clinical Efficacy of Y-STRUT® Medical Device Implanted for Contralateral Percutaneous Internal Fixation of Proximal Femur, in Patient With a Low Energy Per Trochanteric Fracture on the First Side

HIP50 is a national, multicentre, prospective, observational study, in patients presenting a first low energy per trochanteric hip fracture on one side and treated with Y-STRUT® device implanted on the contralateral proximal femur as percutaneous internal fixation to prevent contralateral hip fracture in case of osteoporosis.

The primary objective of this study is to evaluate the clinical efficacy of the studied medical device by measuring the frequency of patient with a fracture at the implantation site within 1 year after implantation.

A total of 50 patients from France will be enrolled (until December 2020) and followed up to 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Patient of 60 years and older, according to CE indication;
* Patient with information form signed to participate in the study;
* Patients presenting a first low energy hip fracture on one side and having a Y-STRUT® device implanted on the contralateral hip between 0 and 120 days after the treatment of the fracture of the first hip;

Exclusion Criteria:

* Patient who refuse to participate to this study;
* Patient implanted with Y-STRUT® for another indication;
* Patient already enrolled in a clinical study, excluding his participation to HIP50.
Efficacy of Subtenon's Block With Olive Tipped Cannula

The purpose of this study is to compare the efficacy of olive tip cannula to the standard Steven's cannula in performing subtenon's anesthesia for patients undergoing cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing cataract extraction procedure under local anesthesia

Exclusion Criteria:

* Patients allergic to local anesthetic solutions.
* Presence local sepsis,
* Previous retinal or strabismus surgery in the same eye.
* Orbital abnormalities
* Previous subtenon's block in the same quadrant.
Effectiveness of FACoT for Individuals Post Stroke

To develop and assess the effectiveness of a novel cognitive-functional intervention (FACoT) in occupational therapy for people after mild to moderate stroke.


Eligibility Criteria:
inclusion criteria:

* \>18 years
* at least three years post stroke
* severity mild to moderate (NIHSS≤5)
* independent prior to the stroke
* can understand and speak Hebrew

Exclusion Criteria:

* with no other neurological or psychiatric conditions
* without dementia
Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.

This prospective, non-randomised, open-label, clinical trial is conducting on polycystic ovary syndrome (PCOS) subjects to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on clinical and embryological IVF/ICSI outcomes, and on the follicular fluid levels of Placental Growth Factor (PlGF); which is known for his pivotal role in the regulation of ovulation, embryo development, and implantation


Eligibility Criteria:
Inclusion Criteria:

* PCOS women diagnosed according to the Rotterdam criteria undergoing IVF/ICSI.
* Age: 18-39 years.
* Both ovaries present.

Exclusion Criteria:

* Age ≥ 40 years.
* History of three or more previous IVF failures.
* Patients with hormonal disorders like hyperprolactinemia, thyroid disorders.
* Patients who previously undergo Unilateral Oophorectomy.
* Patients with chronic diseases: diabetes mellitus, cardiovascular diseases, liver diseases, kidney diseases.
* Patients with diseases may affect IVF outcomes: Endometriosis, uterine fibroids, Hydrosalpinx, Adenomyosis, autoimmune diseases,
* Cancer.
Comparison of the HyperQ Versus Conventional Electrocardiogram (ECG) to Detect Ischemia

The purpose of the investigation is to verify the efficiency of the HyperQ™ system in detecting exercise induced ischemia, with higher specificity and sensitivity than conventional ECG Stress testing. The study will be carried out by applying the HyperQ™ system during cycle ergometer stress testing in patients who are referred for angiography at the Department of Cardiology, Essen University Hospital, Essen, Germany. The HyperQ™ results will then be compared to the standard ECG stress test results using the angiography results as the gold standard. The study will be considered successful if analysis of the HyperQ provides a statistically significant improvement over the diagnostic accuracy of conventional ECG stress testing analysis.


Eligibility Criteria:
Inclusion Criteria:

* A patient who was referred to angiography.
* A patient who is able (i.e., no contraindications) to perform an exercise stress test
* A patient who signed an informed consent form.

Exclusion Criteria:

* Contraindications for an exercise test.
* Wolff-Parkinson-White (pre-excitation) syndrome.
* Left Bundle branch block, Complete Right bundle branch block or QRS duration \> 120 ms, change in QRS morphology during exercise.
* Atrial Fibrillation or significant ventricular arrhythmia
* Treatment with Digoxin.
* Pacemaker.
* Having taken beta blockers within 24 hours before the exercise test.
* Pregnancy or suspected pregnancy.
A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease

A study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease. This study includes a sub-study evaluating kidney Gb3 inclusions (and other histologic lesions) in male participants with classic Fabry disease who have been treated for at least 2 years with lucerastat monotherapy in study ID-069A302.

Study ID-069A302 will continue at each site until lucerastat is commercially available in the respective country or until all subjects have reached Month 24 (for subjects participating only in Stage 1) or Month 48 (for subjects participating in Stages 1 and 2) or Month 72 (for subjects participating in Stages 1, 2 and 3), whichever is earliest.

Eligibility Criteria:
Inclusion Criteria:

* Signed ICF prior to any study-mandated procedure;
* Subject completed the 6-month, double-blind treatment period in study ID 069A301
* Woman of childbearing potential only if agreement 1) to follow a specified contraception scheme, 2) to undertake monthly urine pregnancy tests.
* Fertile male only if agreement 1) to use a condom, 2) to not father a child.

Exclusion Criteria:

* Pregnant / planning to be become pregnant or lactating subject;
* Subject considered to be at high risk of developing clinical signs of organ involvement within the time period of the study, as per investigator judgment;
* Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results as per investigator judgment.

In addition, the subject must not be enrolled in study ID-069A302 if at any time during study ID-069A301, one of the following criteria was met:

* Subject's eGFR per the Chronic Kidney Disease Epidemiology Collaboration creatinine equation \< 15 mL/min/1.73 m2;
* Subject experienced an event of acute kidney injury Common Terminology Criteria for Adverse Event (CTCAE) grade 2 or above;
* Subject experienced an event of stroke CTCAE grade 3 or above;
* Subject experienced an event of heart failure leading to in-patient hospitalization or prolongation of ongoing hospitalization.
Automated Echocardiographic Detection of Coronary Artery Disease Using Artificial Intelligence Methods

The incidence rate and mortality of coronary artery disease are increasing year by year. Exploring non-invasive, accurate, and widely applicable methods to screen and diagnosis is of great significance. New ultrasound techniques, such as non-invasive myocardial work, have been proven to be superior to traditional ultrasound techniques in screening and diagnosis. However, diagnostic analysis based on ultrasound video images is time-consuming and subjective. The progress of artificial intelligence technology in fully automated quantitative evaluation of video images provides the possibility for computer-aided design screening and diagnosis. At present, the application of artificial intelligence in computer-aided design is a cutting-edge issue in the field of cardiovascular disease research. The application of artificial intelligence technology in the construction of computer-aided diagnostic models based on ultrasound video images is still in its early stages.

1) Clarify the value of new cardiac ultrasound techniques indicators in coronary artery disease diagnosis; 2) To achieve classification and detection of cardiac ultrasound sections; Implementing automatic segmentation and recognition of the left ventricular cavity, left ventricular myocardium, and left atrial wall contours through the CLAS model; Using the another model to achieve heart motion tracking and synthesizing velocity vector maps of the heart flow field. 3) Verify and optimize the coronary artery disease fully automated artificial intelligence diagnostic model mentioned above.

Eligibility Criteria:
Inclusion Criteria:

Patients with suspected coronary artery disease who plan to undergo coronary angiography

Exclusion Criteria:

Patients with ①Aortic valve stenosis, aortic valve replacement surgery, hypertrophic cardiomyopathy; ②Severe heart valve disease, arrhythmia, cardiomyopathy, congenital heart disease; ③The quality of ultrasound images is poor.