cyrilzakka/clinical-trials huggingface dataset:
The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty

The overall goal of the study is to determine if repairing the subscapularis tendon during primary reverse shoulder arthroplasty effects short-term patient outcomes. The study is a patient blinded randomized controlled trial that is currently enrolling.


Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing primary reverse shoulder arthroplasty

Exclusion Criteria:

* Adults without an intact subscapularis
* Inflammatory arthritis
* Revision surgery
Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer

Lung cancer is the leading cause of cancer related mortality. At present, surgical treatment is the main choice for early-stage lung cancer. Even after surgery, the 5-year recurrence rate is still as high as 18.4%-24%. Traditional Chinese medicine combined with thermal and cold ablation could be an alternative treatment. Small sample clinical cases verified that this therapy could be an efficacy and safe treatment in a short period. The primary aim of this trial is to evaluate the efficacy of traditional Chinese medicine combined with thermal and cold ablation for patients with stage I non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good.
* Patients with lung nodule.
* Maximum diameter of lung nodule ≥8mm.
* The pathology of lung nodules biopsy was non-small cell lung cancer.
* I period according to the eighth edition of the TNM staging period.
* No mediastinal lymph node metastasis.
* Eastern Cooperative Oncology Group performance status of 0 to 1.
* No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
* Sufficient organ functions.

Exclusion Criteria:

* Patients with previous use of various hormones, immunosuppression or autoimmune diseases.
* Women during pregnancy or breast-feeding.
* Patients with severe heart, lung, kidney disease or other systemic diseases
* Patients with severe hemorrhagic diseases.
* Patients with a history of drug abuse or mental illness.
* Other conditions that the investigator has determined are not suitable for participation in this study
Neutrophil-to-lymphocyte and Platelet-to-lymphocyte Ratio in Predicting the Incidence of Nausea and Vomiting

By comparing the incidence of PONV, the dosage of postoperative antiemetic drugs, the postoperative VAS score and the utilization rate of PCIA of hemophilia A patients in the NLR≥2 and NLR\<2 groups, investigators could find out the high value in the diagnosis of hemophilia A, which is helpful to guide the clinical diagnosis and treatment of hemophilia A.

Hemophilia arthropathy is a debilitating complication of hemophilia that occurs primarily in severe forms with recurrent spontaneous intra-articular hemorrhage, with the knee being the most commonly affected joint. Currently, total knee arthroplasty is the standard treatment for end-stage hemophilic arthropathy. Due to the special disease of hemophilia, general anesthesia is often chosen as the preferred anesthesia method, and the risk of bleeding is lower than that of neuraxial anesthesia. However, 20 to 30 percent of surgical patients suffer from post-operative nausea and vomiting after general anesthesia. Neutrophil to lymphocyte ratio and platelet to lymphocyte ratio have been suggested as parameters for the diagnosis and follow-up of inflammatory diseases, and inflammation has been found to increase the risk of PONV. However, for patients with hemophilia, no information is currently available on the relationship between the two. In this study, investigators intend to retrospectively analyze the clinical data of patients with hemophilia A in our hospital, explore the clinical value of preoperative NLR and PLR in predicting nausea and vomiting after TKA.

Eligibility Criteria:
Inclusion Criteria:

1. The patients with hemophilia A undergoing unilateral total knee arthroplasty.
2. The age of the patients ranged from 18 to 70 years.
3. American Society of Anesthesiologists is graded as I\~III
4. No history of mental illness
5. No history of antiemetic and anticholinergic drugs.
6. No history of serious gastrointestinal diseases.

Exclusion Criteria:

1. Patients who have received long-term steroid treatment
2. Patients who need more than 2.5 mg neostigmine to reverse muscle relaxants
3. Patients with previous malignant tumor, malabsorption, morbid obesity, hypogonadism, thyroid and parathyroid diseases and autoimmune diseases.
mHealth Messages to Sustain Recent Weight Loss - Phase 2

To assess the feasibility to translate an automated weight loss message intervention to a weight loss clinic population.

Aim 1: To assess feasibility of translating the intervention in a clinic for patients who recently completed a structured weight loss program.

Aim 2: To assess the ability to capture a trajectory of self-reported weight over 6 months through an automated intervention.

The investigators will recruit 100 participants who are clients at the Duke Diet and Fitness Center. At baseline the investigators will collect demographic information such as, their age, weight, education. When participants complete their respective program at the DFC they will receive a daily weight loss sustaining text message at 8:00 A.M. for 60 days. Participants will also receive weekly messages for 6 months asking them to self-report their weight. Thereafter, they will receive an automated message monthly for 18 months asking them to self-report their weight.

Eligibility Criteria:
Inclusion Criteria:

* A client of Duke diet and Fitness Center (DFC)
* Are able to speak and read English
* Should complete a diet and fitness program at the DFC.
* Client should own a mobile smart phone to personally receive text messages.
* Client should have access to a web-based survey to self-report their weight.

Exclusion Criteria:

* No exclusions
Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? the D-Vex Pilot Study

Vitamin D is known to have a regulatory influence on both the immune system and skin barrier function. Studies in paediatric populations have found an inverse association of vitamin D levels and with both prevalence and severity of atopic dermatitis (AD). Trials of vitamin D as a treatment for AD are limited in number and size. There has never been a placebo-controlled randomised controlled trial of stoss high dose versus daily standard dose for the treatment of AD. Further, no trials have explored the presence of vitamin D pathway genes and response to treatment of AD. This pilot study will be used as a reference to determine outcomes and feasibility for undertaking a larger and more in depth definitive study.


Eligibility Criteria:
Inclusion Criteria:

* moderate to severe atopic dermatitis with a SCORAD ≥ 20 at baseline.
* aged between 1 ≤ 12 years of age at the time of randomisation.
* regularly ingest the recommended dietary intake (RDI) of calcium and plan to do so for the next 3 months
* have a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Exclusion Criteria:

* use of vitamin D supplementation, including a stoss dose of vitamin D in the previous year, or daily supplementation in the past month
* drink vitamin D fortified formula (all formulas) as the main milk intake
* received oral steroids within the past 6 months
* received oral immunosuppression in the past (cyclosporine, azathioprine, methotrexate)
* received UV therapy in the past 12 months
* have been fully formula fed within the past 6 months
* ave renal or liver or gastrointestinal (e.g.: coeliac, inflammatory bowel disease) disease
* receiving thiazide-type diuretics or anticonvulsant therapy
* have ever been diagnosed with Hypercalcaemia, Hypertension or Rickets
* unable to provide consent without the aid of an interpreter
* in the opinion of the Investigator, are unable to follow the protocol
Bleb Function and Morphology With Intratendon Injection of MMC Compared With Standard Method

Patients with advanced glaucoma that are candidates for trabeculectomy will be included.

Thorough ophthalmic examination including best corrected visual acuity, slit lamp examination, intraocular pressure (IOP) measurement, gonioscopy, funduscopy and specularly microscopy will be performed for all participants. Patients will be assigned randomly to 2 groups. In one group they will undergo fornix based trabeculectomy with conventional MMC 0.02% soaked sponges application. In the other group 0.1 cc of 0.01 MMC will be injected into the tenon at the beginning of the surgery. The rest of the operation is the same for both groups as standard trabeculectomy. Ophthalmic examination including IOP measurement will be performed at one, 3 and 6th month post surgery. Specular microscopy will be requested at final follow up visit. Bleb morphology will be scored according to Indian grading system at 3rd and 6th months post surgery.


Eligibility Criteria:
Inclusion Criteria:

* Advanced uncontrolled glaucoma patients.

Exclusion Criteria:

* History of any kind of intraocular surgery.
* Monocular patients.
* Unwillingness to participate in the study
Gastroparesis in type2 Diabetic Patient

Gastroparesis is defined by objective delaying of gastric emptying without any evidence of mechanical obstruction. Diabetic gastroparesis is a potential complication that occurs in the setting of poorly controlled diabetes, resulting from dysfunction in the coordination and function of the autonomic nervous system, neurons, and specialized pacemaker cells (interstitial cells of Cajal, ICC) of the stomach and intestine, and the smooth muscle cells of the gastrointestinal tract

Hyperglycemia (random blood glucose greater than 200 mg/dL), commonly seen in uncontrolled diabetes, has been associated with diabetic gastroparesis resulting from neuropathy in the setting of chronic hyperglycemia and does not resolve with improved glycemic control. Acute hyperglycemia, on the other hand, though it can also result in delayed gastric emptying, is often reversible with improved glycemic control. Although there is a stronger association between type 1 diabetes and gastroparesis, the incidence of type 2 diabetes is much greater, and therefore, gastroparesis associated with type 2 diabetes is seen more frequently. Additionally, incretin mimetics are used to treat patients with type 2 diabetes, and these medications pose an additional risk factor for developing gastroparesis.Gastric emptying scintigraphy (GES) is the investigation of choice for evaluating the disorders of gastric emptying because it is a simple, physiological, and sensitive investigation to objectively assess gastric emptying. Standard imaging is performed at 0,1,2,4 hours postprandially. A four-hour study is more sensitive and accurate in diagnosing gastroparesis, and clinicians should avoid shortened 2- and 3-hour studies.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 DM
2. Age \< 40 years
3. \>5 years of DM

Exclusion Criteria:

1. Type 1 DM
2. History of GIT surgry
3. Medical disease affect gastric emptying
4. Using of prokinetic
Iron Sucrose in Patients With Iron Deficiency and POTS

This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in patients with Postural Orthostatic Tachycardia syndrome (POTS).


Eligibility Criteria:
Inclusion Criteria:

* Patients (age 12 to years and older) with chronic (\>3 months) symptoms of orthostatic intolerance, including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and heart palpitations.
* Symptomatic orthostatic heart rate increment ≥30 bpm if \>19 years old or ≥40 bpm if \<19 years old during a 10 minute 70 degree head up tilt study
* Presence of non-anemic iron deficiency, defined as serum ferritin levels \<20 ug/L with hemoglobin no less than 1 gm/dL below the normal reference range as defined for age and gender
* Consent obtained from responsible guardian AND from subjects, 12-17 years of age
* Consent obtained for subjects 18 years of age and older

Exclusion Criteria:

* Orthostatic hypotension (decrease of systolic BP\>30 mmHg and/or diastolic BP\>15mmHg within 3 minutes of 70 degree head up tilt study)
* Pregnant or lactating females
* The presence of failure of other organ systems or systemic illness that can affect autonomic function
* Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study
* Laboratory evidence of anemia or iron overload
* Personal history of hematochromatosis or first degree relative with hematochromatosis
* Known sensitivity to Venofer® (iron sucrose injection, USP) or other intravenous iron preparation
Comparison of Low-radiation Dose CT Angiography With Invasive Coronary Angiography in Stable Coronary Disease

This study is evaluating the performance of modern CT coronar angiography with low radiation technique compared to conventional invasive coronar angiography. The patients recruited will already be accepted for invasive coronary angiography based on clinical presentation, ECG and biochemical parameters. An "all-comers" design to avoid selection bias and no additional B-blockers will be used prior to CT angiography. The hypothesis is that it is possible to rule out significant coronary artery disease with sensitivity \> 95 % and negative predictive value \> 95 % with very low radiation doses.

Conventional invasive coronary angiography (CICA) is associated with few but serious complications. It is time consuming for the patient and incur costs to the health institution due to the post-procedure observation needed. Coronary computer tomography angiography (CCTA) is a good alternative to CICA to rule out coronary artery disease (CAD). Moderate to excellent sensitivity and negative predictive values have been reported with 64-slice CT angiography. The main ethical problem has been the radiation doses given to the patient during CT angiography which was high \>10 millisievert(mSv). With 265 or higher slice CT machines and radiation dose reduction techniques, it is possible to evaluate coronary anatomy with radiation doses below 1 mSv. Heart rate reduction with B-blockers is in most cases not necessary with new generation CT machines but is recommended in guidelines.

800 patients already accepted for CICA based on clinical information will be scheduled to undergo CCTA prior to invasive coronary angiography. Coronary anatomy will be described according to American Heart Association (AHA) classification with 17 segment analysis. The main purpose of the study is to achieve high sensitivity and high negative predictive value with CT angiography. Radiation doses in relation to gender and body mass index (BMI) will be monitored. In addition we will measure coronary calcification (Agatson score) and look at any association to the Vitamin D and calcium metabolism. Patient reported quality of life evaluation with validated questionnaires and long term follow up (5 and 10 years) regarding clinical endpoints.

Eligibility Criteria:
Inclusion Criteria:

1. 800 Patients who are scheduled to undergo conventional invasive coronary angiogram will be recruited at the University hospital of North Norway, Tromsø.

Exclusion Criteria:

1. Acute coronary syndrome with positive high sensitive troponin.
2. Renal failure with glomerular filtration rate (GFR) \< 30
3. Contraindication to contrast medium
4. Symptomatic Tachycardia \>110 or bradycardia \< 40
5. Pregnancy
6. Lack of informed consent
Sensorimotor Training and Gait in Diabetic Polyneuropathy

Diabetic peripheral neuropathy is a common chronic complication of diabetes mellitus which results in high public health costs and has a huge impact on patients' quality of life. It leads to sensory and motor deficits, which often result in mobility-related dysfunction, and alterations in gait characteristics. These alternations in gait performance cause increase in the risk of fall, which has the strongest association with symptoms of depression in patients with diabetes. However, little is known about possible treatment strategies for improving gait ability and reduce risk of fall in patients with diabetic neuropathy. So, the purpose of this study will be to investigate the effect of sensorimotor training on ankle muscle strength, gait and quality of life in patients with diabetic peripheral neuropathy.

To determine if there is an effect for sensorimotor training on gait, ankle muscle strength and quality of life in patients with diabetic peripheral neuropathy, the patient will be assessed before and after 6 weeks of treatment by measurement of ankle muscles strength using isokinetic dynamometer, measurement of different spatiotemporal gait parameters using gait trainer instrument , and assessment of quality of life of the patients using HRQL questionnaire (SF-36) before and after the treatment sessions.


Eligibility Criteria:
Inclusion Criteria:

* patient who have body mass index did not exceed 30 Kg/m2.
* type II diabetes mellitus diagnosed for at least 7 years.
* able to walk without assistance or assistive device
* able to stand on both feet and on one leg
* have controlled blood glucose level by the screening by Glycated Haemoglobin test (9 % \> HbA1c \> 6.5 %) .

Exclusion Criteria:

The patients will be excluded if they have:

* cognitive deficits, severe retinopathy, scares under their feet, hypo or hypertension, any medical conditions that would confound assessment of neuropathy such as malignancy, active/untreated thyroid disease, other neurological or orthopaedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, or severe osteoarthritis), and severe nephropathy that causes edema or needs haemodialysis.
Clinical Validation of an Artificial Intelligence Algorithm to Help Interpret Mammograms

This aims to clinically validate, on a large population, a tumor detection aid software which has already been trained on a representative French population (from several hospital centers and liberals from several departments in the west and east of France).

This population consists of 1000 patients who have been treated for breast cancer (histologically proven by breast biopsy) and whose investigators have mammograms performed at the time of diagnosis. The control population consists of the unaffected breast of each patient (with the exception of the rare cases of bilateral cancers).

This innovative software has the main feature of recognizing healthy breast tissue, allowing the radiologist to focus on breast tissue at risk, improving the management of medical time and the management of "difficult" files.


Eligibility Criteria:
Inclusion Criteria:

* Adult woman (40 to 75 years old)
* Treatment at the University Hospitals of Strasbourg between 2010 and 2020 for breast cancer
* including mammography and histological evidence available
* Patient who has already given her consent for the reuse of her anonymous data for research purposes

Exclusion Criteria:

* Woman who expressed her opposition to participating in the study
Venous Air Embolism in Cesarean Delivery, Especially Placental Previa

Effects of placenta previa on incidence and severity of venous air embolism in patients during cesarean delivery


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer with cesarean delivery

Exclusion Criteria:

* the one who rejects to participate
Trial of Simvastatin in Amnestic Mild Cognitive Impairment (MCI) Patients

Probands with MCI are at high risk to develop Alzheimer´s dementia (AD). Simvastatin may lower the production of Amyloid, a hallmark of AD in the brain. The primary hypothesis of the study is that 60 mg Simvastatin significantly reduces the Clinical Dementia Rating -Sum of boxes (CDR-SOB) in individuals with MCI as compared to MCI receiving placebo or 20 mg Simvastatin

This is a national multicenter, double-blind, randomized placebo-controlled trial allowing for a minimum follow-up time of 24 months in conversion-free patients. Randomization will be stratified by prior use of statins.

The two strata are:

1. "no-statins": patients without treatment with a statins and no indication for treatment (according to the guidelines of the German Society of Cardiology for the primary prevention of cardiovascular disease); patients will be randomly assigned to one of 2 treatment (1) Simvastatin (60 mg) one tablet/day (2) Placebo one tablet/day.
2. "low-statins": patients treated with low doses of Statins; patients will be randomly assigned to one of 2 treatment (1) Simvastatin (60 mg) one tablet/day (2) 20 mg Simvastatin one tablet/day.

Eligibility Criteria:
Inclusion Criteria:

1. Self and informant report of gradually increasing memory impairment for at least six months.
2. Objective memory impairment
3. Intact basic activities of daily living
4. Preserved general cognitive function, not demented
5. Absence of a detectable cause of memory disorder
6. Age 55 to 90.
7. Females without childbearing potential
8. A total cholesterol ≥90 mg/dl
9. LDL-cholesterol ≥ 160 mg/dl and ≤ 3 risk factors or ≥ 190 mg/dl and ≤ 2 risk factors including age
10. Informed consent (according german medicinal products act, AMG §40 (1) 3b)
11. No participation in other clinical trials 2 months before and after participation in this study
12. Probands should only recruited for the clinical trial, when they are able to perform the informed consent; due to worsening of "memory function" in the course of the clinical trial, probands should not longer participate the clinical trial, when they is evidence, that participants were not longer able to give full informed consent.

Exclusion Criteria:

1. Hypersensitivity against Simvastatin, active liver disease or lasting increase of serum transaminases for unclear reason
2. Unstable medical, neurological or psychiatric disease
3. Lack of a spouse or a close relative
4. Use of a registered anti-dementia drug or a nootropic
5. Chronic use of anti-inflammatory drugs
6. History of stroke or myocardial infarction
7. LDL-cholesterol 130-160 mg/dl and \> 3 risk factors or 160-190 mg/dl and \> 2 risk factors including age.
8. LDL-cholesterol \>190 mg/dl
9. Comedication with Diltiazem, Verapamil, Amiodarone, Itraconazole, Ketoconazole, Erythromycin, Clarithromycin, Telithromycin, Ciclosporin, Gemfibrozil, Nefazodone, HIV-protease inhibitors, Benzodiazepines, Tricyclic antipsychotics or other anticholinergic drugs
10. Comedication of other statins in high doses; low doses equivalent to 20 mg Simvastatin are allowed if taken for max. 2 years before randomization