cyrilzakka/clinical-trials huggingface dataset:
Diagnosis of Hemangiomas and Vascular Malformations

To develop a non-invasive, simple and affordable, measurement technique to differentiate hemangiomas from subtypes of VMS. The purpose of this study is to determine the best office based diagnositc instrument for differentiating the subtype of vascular lesions. The instrument must be simple and affordable so it can be used by primary car physicians in the doctor office. The procedure will be based on non-invasive and unharmful measurements that will be compared to the diagnosis from specialized physicians in this field and the final pathology.


Eligibility Criteria:
Inclusion Criteria:

* Suspected Hemangioma, Vascular Malformations (VMS) including venular Malformations (port-wine stain, PWS), Venous Malformations, Lymphatic Malformations, Arteriovenous Malformations or mixed malformations.

Exclusion Criteria:

* All pregnant individuals will be excluded, since physiologic changes of pregnancy could alter characteristics of the vascular lesion.
Assessing the Utility of Ultrasound Compared to Cross-Sectional Imaging in the Follow-up of Patients With Renal Cell Carcinoma

The aim of this study is to determine the utility of renal ultrasonography (US) in the detection of abdominal recurrences after definitive therapy for renal cell carcinoma (RCC) and compare the detection rate to that of cross-sectional imaging.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 year of age or older.
* Patients having undergone radical or partial nephrectomy for the indication of renal cell carcinoma.
* Most recent imaging study must have been either computed tomography (CT) or magnetic resonance imaging (MRI).

Exclusion Criteria:

* Patients with pT4 disease (tumor invades beyond the Gerota fascia: including contiguous extension into the ipsilateral adrenal gland).
* Patients with metastatic disease prior to time of surgery requiring systemic treatment.
* Patients with another active cancer diagnosis requiring systemic treatment.
* Patients with contrast allergies.
* Patients with baseline chronic kidney disease (GFR \< 45 ml/min/1.73 m2).
Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea

The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent,
* Men or women between 18 and 85 years of age,
* History of arriving from their country of residence in the industrialized part of the world within the past 4 weeks,
* Presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or soft stools accompanied by symptoms within 24 hours preceding randomisation with duration of illness ≤ 72 hours),
* Presence of one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, fecal urgency),
* Women of childbearing potential had to apply during the entire duration of the study a highly effective method of birth control

Exclusion Criteria:

* Residency in any country with high incidence rate of TD within the past 6 months,
* Fever (defined as a body (oral) temperature \>100.4°F or 38.0°C; antipyretic medication should not have been administered in the 6 hours prior to this assessment),
* Known or suspected infection with non-bacterial pathogen,
* Presence of diarrhoea of \>72 hours duration,
* Presence of grossly bloody stool,
* Presence of moderate or severe dehydration (i.e. symptoms of hypovolemia such as orthostatic hypotension, dizziness or wrinkling of skin),
* History of inflammatory bowel disease or celiac disease,
The Ultrasonographic Measurement of Quadriceps Muscle Thickness and the Shape of the Femoral Nerve in Patients Undergoing Total Knee Arthroplasty: an Observational Study

For each individual, the femoral nerve shows various shapes and locations. This is because the femoral nerve is located on top of the iliacus muscle, so the shape and location of the femoral nerve seems to be related to the patient's muscle mass. Ultrasound of the quadriceps femoris could represent a widely available, non-invasive, affordable, and reliable tool to evaluate skeletal muscle. We aim to investigate the relationship between muscle mass and the shape of the femoral nerve through this observational study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 19 years old or older and scheduled for elective total knee arthroplasty

Exclusion Criteria:

1. Pre-existing neurologic or anatomic deficits in the lower extremities
Optimized Rehabilitation Following Primary Breast Cancer Surgery

This study aims to evaluate the effects of an intervention based on systematic screening of psychological distress as the basis for individualised support and rehabilitation following primary breast cancer surgery focusing on psychological , physical and health-economics outcomes. The aim is also to illuminate patients' and relatives' experiences and need of support during the rehabilitation .

Breast cancer survivors are known to suffer from remaining problems from their treatment after surgery. Despite numerous of studies evaluating the effect of various rehabilitation programs it is know that patients often receive rehabilitation recommendations that are general rather than individualised to their needs. The large amount of studies within this area have contributed to knowledge about potential beneficial rehabilitation interventions for these patients but there is still a lack of knowledge about how patients specific needs of rehabilitation can be identified and how health care can adjust and individualize rehabilitation to optimize rehabilitation. This study aims to evaluate the effects of an intervention based on systematic screening of psychological distress as the basis for individualised support and rehabilitation following primary breast cancer surgery focusing on psychological , physical and health-economics outcomes. The aim is also to illuminate patients' and relatives' experiences and need of support during the rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Undergone treatment for primary breast cancer
* ≤18 years old
* Ability to communicate in Swedish
* Written informed consent

Exclusion Criteria:

* Recurrent disease
* Palliative diagnosis
* Pregnancy
* Prior history of breast cancer
* Inability to participate in the study due to cognitive impairment
Neuromuscular Electrical Stimulation in Chronic Low Back Pain

This study evaluates whether there is additive effect of neuromuscular electrical stimulation applied to lower lumbar region to core stabilization exercises in the management of chronic low back pain. Participants will randomly divide into two groups; half will receive core stabilization exercises and neuromuscular electrical stimulation (NMES) in combination, while the other half will receive core stabilization exercises and sham NMES.

Patients with low back pain cannot activate enough the deep lumbar stabilization muscles necessary for spinal stability, such as transversus abdominis, lumbar multifidus.

Core stabilization exercises are valuable in motor relearning of coactivation of deep lumbar and abdominal muscles and in stabilization of the spine. Hence, they are important in the management of chronic low back pain.

Neuromuscular electrical stimulation (NMES) has been used in the training and strengthening of skeletal muscles for many years. It is shown that NMES can contract deep lumbar stabilization muscles and changes in muscle activation are significantly associated with pain reduction in patients with low back pain.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* Pain intensity greater than 3 over 10,
* Pain duration more than 3 months,
* Consent to participate in the study

Exclusion Criteria:

* Previous lumbar surgery,
* Radiculopathy,
* Non-mechanical back pain,
* Acute low back pain
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin

A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.


Eligibility Criteria:
Inclusion Criteria:

* a Healthy male subject, aged 19- 50 years

Exclusion Criteria:

* History of clinically significant hypersensitivity to study drug, any other drug
* Hypotension or hypertension
* Active liver disease
* History of gastrointestinal disease
* History of excessive alcohol abuse
* Participation in any other study within 3 months
Tunneling Technique in Treatment of Miller's Class III Gingival Recession

Several surgical techniques have been proposed to correct recession defect and attain root coverage. Though, the majority were executed on Miller Class I and II recession defects. Moreover, Analysis of literature revealed only a few studies that treated miller class III recession defects.

In the current study, a new modification in the free gingival graft is proposed to provide the patient with more esthetic outcome, less pain and postoperative trauma. Likewise, the proposed graft modification will combined both FGG and CTG benefits, overcome the limitations of the FGG and enhances the advantages of CTG.

In the current study, patients with Miller's class III will be randomly allocated in two groups. In the first group, gingival recession will be treated by tunneling technique with subepithelial connective tissue graft (sCTG). the tunnel preparation will be performed in the recession site then the sCTG will be harvested from the palate and inserted in the prepared tunnel and sutured in a coronally advanced position.

Equally , the second group will be treated with modified free gingival graft (mFGG). Initially, after tunnel preparation in the recession site and harvesting of the free gingival graft,the proposed modification is performed by mimicking the recession defect shape and size leaving the rest of the free gingival graft deepithelialized and inserted in the prepared tunnel. then, suturing will be performed in a coronally advanced position.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with healthy systemic condition.
2. Buccal recession defects classified as Miller class III.
3. Clinical indication and/or patient request for recession coverage.
4. O'Leary index less than 20%.

Exclusion Criteria:

1. Pregnant females.
2. Smokers as smoking is a contraindication for any plastic periodontal surgery.
3. Unmotivated, uncooperative patients with poor oral hygiene
4. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.
Virtually-integrated Co-management Between Complex Care and Community-based Primary Care Providers

This is a pilot trial to test whether tertiary center-affiliated pediatricians with expertise in medical complexity joining medical visits with patients' community primary care providers is feasible and acceptable. We will also collect data on a range of patient-centered and utilization outcomes to determine effect compared to usual care.


Eligibility Criteria:
Inclusion Criteria: Caregiver of patient seen for co-managed care in Special Care Clinic; caregiver has a smartphone that will accept the technology; PCPs office has wireless internet connection -

Exclusion Criteria: Child is in foster care

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Univation XM France

The study is set up due to regulatory purposes and to collect routine clinical data of the mobile-bearing implant univation XM. The study is designed as a prospective follow-up study with a historic patient cohort who have been treated with the product under investigation two years ago. This design is selected to quicker realize follow-up data as patients have already been treated in the past.

As the mobile version of the implant is not widely used, the study will be set up as a monocentric study in France. The clinical hypothesis of the study is that patients who are treated with the product under investigation have a similar outcome and survival rate in comparison to other established unicondylar knee systems on the market. Comparison for the later evaluation will be taken out of recent orthopaedic registries.


Eligibility Criteria:
Inclusion Criteria:

* Patient has received a primary mobile bearing UKA at the study site between January 2017 and December 2018 using the product under investigation
* Patient's written consent and willingness to participate at the clinical study and the follow-up examinations

Exclusion Criteria:

* Pregnancy
* Patient Age \<18 years at the time of the surgery
A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) in Adults.

To evaluate the effect of multiple subcutaneous (SC) doses of benralizumab (MEDI 563) on the rate of moderate-to-severe annualized incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with moderate-to-severe COPD who exhibit eosinophilia (greater than or equal to \[\>=\] 3.0 percent \[%\] sputum eosinophilia in the previous 12 months or at Screening) in sputum compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 40-85 years at the time of Screening
* Written informed consent obtained from the subject prior to performing any protocol related procedures
* Documented history of 1 or more Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
* Current smoker or ex-smoker with a tobacco history of greater than or equal to (\>=) 10 pack-years
* Adequate contraception from screening through end of trial
* Able to read and write.

Exclusion Criteria:

* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
* Pregnant, breastfeeding, or lactating women
* Known history of allergy or reaction to any component of the investigational product formulation
* History of anaphylaxis to any other biologic therapy
* Donation or transfusion of blood, plasma or platelets within the past 3 months prior to Screening
* Other significant pulmonary disease which in the opinion of the investigator or medical monitor, might compromise the interpretation of the study
* Fever greater than (\>) 37.0 degree Centigrade (98.6 degree Fahrenheit) at Screening
* Receipt of any novel investigational medicinal product within 3 months before the first dose of investigational product in this study and through the end of the study
* Seropositive for hepatitis A, hepatitis B surface antigen, hepatitis C, or human immunodeficiency virus 1or 2 (HIV-1 or HIV 2)
* History of alcohol or drug abuse within the past year that required treatment that the investigator felt or medical monitor felt would compromise the study data interpretation
* Past or current malignancy within the past 5 years except adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than 1 year prior to Screening
* Subjects participating in, or scheduled for, an intensive COPD rehabilitation program (subjects who are in the maintenance phase of a rehabilitation program are eligible to take part)
* Current diagnosis of asthma according to Global Initiative for Asthma guidelines
* Previous treatment with MEDI-563.
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of large duct PSC
* Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader
* Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:

  * Platelet count ≥ 150,000/mm\^3
  * Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
  * Alanine transaminase (ALT) ≤ 8 x upper limit of the normal range (ULN)
  * Total bilirubin \< 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia
  * International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
  * Negative anti-mitochondrial antibody

Key Exclusion Criteria:

* Current or prior history of any of the following:

  * Cirrhosis
  * Liver transplantation
  * Cholangiocarcinoma or hepatocellular carcinoma (HCC)
  * Ascending cholangitis within 30 days of screening
* Presence of a percutaneous drain or biliary stent
* Other causes of liver disease
* Current or prior history of unstable cardiovascular disease
* Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Evaluation of the Implementation of Drug Prescription Recommendations Using Clinical Decision Support in Patients With Severe Obesity: Retrospective Study

No drug prescription guidelines for severe obesity (BMI\>35 kg/m2) are available, leading to non-standardized and / or potentially inappropriate drug management.

After validation of guidelines by the Delphi method, the main objective is to assess the agreement between the drug prescriptions and the guidelines after implementation in two health data warehouses.

The investigators will perform a retrospective, multicentric study in 2 hospitals. The investigators will check the relevance of rules (alerts) derived from the recommendations identified using the Delphi method.

No drug prescription guidelines for severe obesity (BMI\>35 kg/m2) are available, leading to non-standardized and / or potentially inappropriate drug management.

After validation of guidelines by the Delphi method, the main objective is to assess the agreement between the drug prescriptions and the guidelines after implementation in two health data warehouses.

The investigators will perform a retrospective, multicentric study in 2 hospitals. The investigators will check the relevance of rules (alerts) derived from the recommendations identified using the Delphi method.

The sponsor anticipate around 800 patients in the HEGP data warehouse and around 250 patients in the Rennes University Hospital data warehouse.

The main outcome will be the number of prescriptions concerned by rules, by type of recommendation, in patients with severe obesity.

Secondary outcomes will be :

1. Number of validated recommendations and their level of evidence,
2. Rate of prescriptions concerned by a computerized rule with pharmaceutical advice on the drug concerned by the rule. Sub-group analysis of this rate by type of recommendation.

The study will be conducted in 2 steps:

* Stage 1 (secondary endpoint): it consists of the final drafting of recommendations and submission to experts/analysis of feedback. This stage is scheduled to last 12 months.
* Stage 2 (primary and secondary judgment criteria): it consists of implementing the recommendations and studying the relevance of the rules. This stage is scheduled to last 8 months.

Around a hundred patients corresponding to this criteria will be extracted from the HEGP data warehouse

Eligibility Criteria:
Inclusion Criteria:

All patients aged 18 to 65 at the time of prescription with a BMI\>35 kg/m² present in the clinical data warehouse of the HEGP and CHU Rennes during the study period with at least one hospitalization of more than 24h.

Exclusion Criteria:

* Patients who refused to have their records processed electronically.
* Patients with a history of bariatric surgery (sleeve gastrectomy, gastric band, gastric bypass) prior to hospitalization.
Abdominal Wall Closure After Laparotomy in Oncologic Surgery

The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable.

REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures. In this study, REBUILD will be used in oncology patients undergoing an open, elective, intent-to-cure, laparotomy procedure. The study is a prospective, non-randomized, multi-center study designed to generate descriptive data about the use of REBUILD. The primary safety outcome is reported device-related adverse events. The primary performance outcome is the integrity of the abdominal wall over one year assessed by clinical examination of the abdomen. If available, CT studies performed within 12 months post-procedure will be used to confirm apposition of the medial border of the rectus muscles and integrity of the abdominal wall.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is 18-75 years of age
2. Patient is scheduled for oncologic, open, elective, intent-to-cure laparotomy
3. Patient is able to provide written informed consent
4. Patient is able and willing to comply with all study requirements

Exclusion Criteria:

1. Patient is scheduled for a palliative procedure
2. Patient has had previous failed surgical repair of a ventral or incisional hernia
3. Patient has a current infection at the intended surgical site
4. Patient is participating in a concurrent investigational medical device study
5. Patient is pregnant or planning on becoming pregnant during the study period
6. Patient has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to be compliant with post-operative visits.