cyrilzakka/clinical-trials huggingface dataset:
Study on the Application of Hyperspectral Imaging Technique in CTX Treatment of IMN

Investigators propose hyperspectral imaging analysis as a method to distinguish the efficacy of hormone-combined cyclophosphamide therapy for PMN, and classify sensitive and insensitive patients treated with hormone-combined cyclophosphamide regimen. A variety of machine learning models were used to prove that hyperspectral imaging technology could assist patients in selecting the optimal treatment plan, and further explore the predictive indicators of PMN treatment effect.

Renal puncture pathological sections from patients with nephropathy. ENVI Classic software was used to process the hyperspectral images and delineate the region of interest, and the one-dimensional spectral data of each pixel in each region were derived. Machine learning and deep learning methods were used to analyze the characteristics of hyperspectral data and classify them.

The data of the previous study came from the Department of Pathology and Nephrology of Qianfoshan Hospital in Shandong Province. Under the light microscope, electron microscope and immunofluorescence microscope, the pathological types of glomerular diseases in patients with proteinuria were identified. By scanning the corresponding patient's H\&E stained pathological sections, the hyperspectral microscopic images were classified by machine learning and deep learning methods, and the classification accuracy was greater than 85%. It was concluded that hyperspectral imaging technology can be used as a non-invasive diagnostic method to predict treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old;
* Patients with idiopathic membranous nephropathy confirmed by renal biopsy;
* Had not received hormone and/or immunosuppressive therapy before renal biopsy;
* Complete clinical data, all signed the "Admission Certificate of Qianfoshan Hospital of Shandong Province", and agreed to use relevant medical information, biological specimen examination and examination results for scientific research.

Exclusion Criteria:

* 1.There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or poisons, etc. ;
* Severe infection: fever, cough and expectoration, sore throat, abdominal pain, diarrhea, carbuncle and furuncle and other clinical manifestations of skin and soft tissue infection, blood routine white blood cell count beyond the normal range (10×109/L);
* Severe cardiovascular disease: including chronic heart failure grade 3 or above and various arrhythmias;
* Infectious diseases: active hepatitis, AIDS, syphilis, etc. ;
* Tumor evidence: it has been found that there is a certain tumor or clinical manifestations, tumor markers, etc., suggesting the possibility of tumor;
* Patients with follow-up time less than 6 months, incomplete data or missed diagnosis;
An Early Warning Model of Unfavorable Outcomes Following Endovascular Interventional Treatment of Intracranial Aneurysm

Endovascular treatment has become one of the primary treatment methods for intracranial aneurysms. The unfavorable outcomes during follow-up included aneurysm recurrence and long-term incomplete-occlusion, which would bring a high risk of rebleeding and retreatment. Previous studies have tried to predict the outcomes of aneurysms following endovascular treatment based on aneurysm characteristics including morphology, embolization packing degree, etc, but the conclusion was inconsistent. Hemodynamics of aneurysms and parent artery played a greater role in predicting outcomes following endovascular treatments. Investigators also found that the outcomes were determined by many factors, in which the demography, clinical indicators, treatment methods, and material selection can not be ignored, and the mechanism of unfavorable imaging outcomes should be explored using large samples of clinical cases and numerous variable parameters. The pre-experiment of investigators confirmed that artificial intelligence technology can meet the calculation requirements for deep mining and analysis of large sample data. This study aims to use the deep learning model to identify relevant risk factors and weights, establish a stable and accurate prediction model, then incorporate the prospective study to verify the model. The results will be very helpful in accurately predicting the adverse outcomes such as recurrence and long-term non-occlusion after endovascular treatment and help to improve the therapeutic strategy and avoid risk factors. Besides, the occurrence of ischemic or hemorrhagic complications during follow-up may affect the final follow-up outcome, so the analysis was included as one of the outcome events to evaluate the prognosis after intervention.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of intracranial aneurysm；
* Endovascular intervention was performed；
* The age is more than 18 years and less than 80 years;
* At least one follow-up of imaging data must be digital subtraction angiography with a time interval of 12 months or more;
* The quality of image data can satisfy morphological measurement and hemodynamic calculation;
* The patient family members were informed and consented to participate in the study.

Exclusion Criteria:

* Dynamic aneurysms with cerebrovascular malformation;
* Dissecting, fusiform or thrombotic aneurysms;
* Follow-up images were not digital subtraction angiography or data quality can not meet the hydrodynamic analysis.
Treatment for Patients With Chronic Post-Concussion Symptoms

The current project will examine the effect of a brief psychological intervention on post-concussion symptoms, neurocognitive function, cerebral blood flow (CBF), and psychophysiological and salivary cortisol markers of autonomic nervous system (ANS) in a sample of 20 participants between 13-25 years of age who experience long-term post-concussive (PC) symptoms 2-9 months post-injury as well as 20 age- and sex-matched controls (non-injured) participants to provide normative data on all the above measures except for concussive symptoms.

Participants with concussion will participate in six, home-based interventions designed to treat cognitive-behavioral factors that are maintaining their symptoms. The investigators hypothesize that the prolonged PC symptoms are in part due to disruption of autonomic nervous system function post-injury as well as exacerbation by the psychological response to the injury. This hypothesis is based on evidence showing that PC symptoms, including headache, fatigue, dizziness, and heightened anxiety overlap with upregulated sympathetic activity and elevated levels of salivary cortisol. There is evidence linking cognitive-behavioral factors (e.g., catastrophizing) to prolonged symptoms of autonomic overactivation after injury (e.g., anxiety, pain, etc.). The participants are taught shallow breathing techniques to normalize parasympathetic activity and provide cognitive-behavioral treatment to reduce psychological reactions to the injury that exacerbate the autonomic disruption and prolong recovery.

Eligibility Criteria:
Inclusion criteria for patients:

* Between the ages of 13-25
* Diagnosed with a concussion or mild traumatic brain injury by a physician
* Currently experiencing post-concussive symptoms for at least two months after their injury but no longer than 9 months.
* Fluent English speaker

Exclusion Criteria:

* History of/or comorbid neurological conditions that might affect performance (including history of stroke, seizure disorder, moderate to severe traumatic brain injury, anoxia)
* Severe cardiovascular conditions.
* History of psychosis and current substance abuse or dependence.
* Current severe symptoms of depression and/or anxiety.

Additional Exclusion Criteria for Controls:

\* No history of concussion in the past year.
Efficacy of Collagen-elastin Dermal Substitute in the Treatment of Loss of Cutaneous Substances With Skin Grafts

In reconstructive surgery , most losses of cutaneous substance require the use of a thin skin graft . This technique allows epidermization of the defect by applying a thin layer of autologous epidermis. It does not reconstitute the injured skin. Transplants cause retractile scars, adherent to the deep plan, that may require revision surgery . Since a decade , dermal matrices are mainly used in burned skin centers . The collagen -elastin matrix has the advantage to set up in the same operation that the skin graft and contain elastic fibers , two assets which improve the results of skin grafting.

Objective:

Evaluation of the clinical efficacy of the addition of a dermal matrix to skin graft on Skin Foldability, at day 360.

Methodology:

This is a multicenter randomized study (CHU Caen , Amiens, Rouen and Lille)

Conduct of the study :

The transplant will be performed according to the protocol defined between inter -region surgeons. The implementation of the dermal matrix will be in the same surgical technique as thin skin graft ( group 1 ) or the thin skin graft will be performed alone ( group 2) time .

Evaluation Criteria Main : Skin Foldability ( Uf ) assessed grafted site will be compared to the opposite side ungrafted evaluated at Day 360 . Quantitative data will be measured by a cutometer Skin Elasticity Meter 580 (Courage and Khazaba Electronic GmbH).

To achieve the main objective, it is planned to compare the ratio between Uf graft site and the opposite healthy site between two groups: skin + matrix graft , or skin graft only. Thus, the Wilcoxon test for independent samples will be used to settle bilateral formulation between the null hypothesis ( there is no difference between the two groups ) and the alternative hypothesis ( there is a difference between the two groups ) . In determining the overall risk of first species to 5% and the power of this test to detect the 90% expected under the alternative hypothesis difference should be the main criterion for evaluating at least 59 patients in each group so 118 patients total.

Prospect If the contribution of a dermal matrix in loss of skin substances improves skin pliability and reduces pain , functional and aesthetic sequelae grafts thin skin , the dermal matrix may be proposed as a complementary treatment in these indications.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18
* Signed informed consent
* Patients with loss of cutaneous substance of at least 15 cm2
* Patient Without bone exposure, vascular, joint or tendon
* Eligibility for surgical treatment by skin graft
* Loss of substance trauma (avulsion, burns) or surgery (skin excision)

Exclusion Criteria:

* Patient with a chronic wound
* Wound superinfected
* Patient unable for local or general skin graft
* Patient with an old or a recent skin injury strictly contralateral to the graft site.
* Patient unable to consent
A Study of RO6807952 in Patients With Diabetes Mellitus Type 2

This randomized, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6807952. Patients will receive multiple weekly subcutaneous doses of RO6870952. The anticipated time on study treatment is 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 to 70 years of age, inclusive
* Diagnosis of type 2 diabetes \>/=3 months and \</=10 years prior to screening
* Fasting plasma glucose \>/=110 mg/dL and \</=240 mg/dL
* Patients on a stable dose of metformin for at least 2 months prior to screening
* Hemoglobin HbA1c \>/=6.5% and \</=10.5%
* Body mass index \>/=25 kg/m2 and \</=42 kg/m2
* Systolic blood pressure \<155 mmHg and diastolic blood pressure \<95 mmHg

Exclusion Criteria:

* Patients with type 1 diabetes
* History of significant renal and hepatic diseases
* History of metabolic acidosis and diabetic gastroparesis
* History of pancreatitis
* History of coagulation disorders or unexplained excessive bleeding
* History of clinically significant cardiovascular disease or severe symptomatic hypoglycemia within 6 months of screening
Symptom Prevalence and Severity in Lumbar Spine Surgery With and Without Dura Rupture

The primary purpose of this study is to assess whether lumbar spine surgery patients with dura rupture differ in symptom prevalence and severity from other lumbar spine surgery patients in the early postoperative phase. This is in order to develop a symptom-specific mobilization algorithm (DURAMOB) that can be used to assess whether patients with dura rupture safe can be mobilized earlier after lumbar back surgery to prevent bed rest complications

Accidental dura rupture is a complication of lumbar spine surgery, with an incidence of 2-18% which can cause cerebrospinal fluid leakage leading to symptoms such as postural headache, photosensitivity, tinnitus, infection, and pseudomeningocele. Traditionally, the condition is treated with postoperatively flat bed rest ranging from 0-72 hours, entailing an increased risk of complications due to bed rest. There is inconsistency in the length of prescribed flat bed rest for these patients, and no consensus exists nationally or internationally. The prescription of flat bed rest is generally made by the surgeons based on their clinical experience.

This quality development project in the clinimetric field aims to develop an assessment tool (Duramob) of perioperative symptoms prevalence and severity in lumbar spine surgery patients with and without dura rupture in the early postoperative phase.

Data is based on clinical auditing comprising a consecutive samples of patients in collaboration with " Center for Rheumatology and Spine Diseases", Rigshospitalet-Glostrup, Denmark.

The Duramob instrument will be developed as an evidence-based algorithm for assessing the potential need for postoperatively restrictive bedrest after dura rupture, - and subsequently to be implemented in clinical perioperative practice. Further scientific testing will following be carried out in a feasibility study and / or as a Randomized Controlled Trial.

This initial study will generate observational evidence investigating the first steps towards establishing a safe mobilisation regime for patients with surgical dura rupture. Ultimately, we seek to avoid unnecessary bedrest and complications derived from perioperative immobilization. Data will be protected in a local clinical database RedCap hosted by the Capital Region Data Management system and follows GDPR regulations. The department leadership approved the project and the local ethical Committee' waived the need for approval.

Eligibility Criteria:
Inclusion Criteria:

Lumbar surgery patients age \>18 years

-

Exclusion Criteria:

Trauma surgery Cancer surgery lumbar fusion surgery
Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)

To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 weeks through exactly 12 weeks
* Healthy infants

Exclusion Criteria:

* Clinical evidence of active gastrointestinal illness
* Fever, with a rectal temperature of greater than and equal to thirty eight degree celsius at the time of immunization
* History of congenital abdominal disorders, intussusception, or abdominal surgery
* History of known prior rotavirus disease
* Known or suspected impairment of immunological function
* Prior administration of any rotavirus vaccine
* Known hypersensitivity to any component of the rotavirus vaccine, e.g. trypsin
Systemic Propranolol for the Treatment of Paediatric Patients With Infantile Hemangiomas

This is retrospective study. The patients treated with oral propranolol at a dose of 2.0 mg/kg per day. Growth parameters (height and weight) were measured at the beginning, the end of treatment and 2 years after treatment. The weight-for-age Z-score (WAZ), height-for-age Z-score (HAZ) and weight-for-height Z-score (WHZ) calculated by the WHO Anthro software were used to assess physical development, and the WHO Child Growth Standards were used as the standards.


Eligibility Criteria:
Inclusion Criteria:

* IHs diagnosed by medical history and physical examination
* no previous treatment with other medications

Exclusion Criteria:

* a history or risk of asthma, reactive airway disease, impaired renal or liver function, heart defects or arrhythmia, hypotension and hypersensitivity to propranolol
* Infants who did not adhere to the treatments or attend follow-up visits
* Infants with other known risk factors for developmental delay or growth restriction, such as prematurity, small for gestational age, or other major congenital malformations, were also excluded
* No other treatment was used during the oral propranolol course
Transjugular Intrahepatic Portosystemic Shunts Improve Survival in Patients With Cirrhosis and Recurrent Ascites

Currently, there is limited evidence regarding the survival benefit of early transjugular intrahepatic portal shunt (TIPS) placement in patients with cirrhosis and recurrent ascites. This observational study aimed to assess whether early TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites. We will compare large volume paracenteses plus albumin (LVP+A） to see if TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites.


Eligibility Criteria:
Inclusion Criteria:

Definite diagnosis of recurrent ascites in cirrhosis (based on clinical symptoms, laboratory and imaging studies, or liver biopsy) TIPS or LVP+A therapy, -

Exclusion Criteria:

Malignant neoplasm, including hepatocellular carcinoma with extrahepatic metastasis Prior liver transplantation Severe heart and lung dysfunction Recurrent hepatic encephalopathy Concomitant active infection TIPS with the use of uncovered stents Complete portal vein thrombosis

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Use of 1-MNA to Improve Exercise Tolerance and Fatigue in Patients After COVID-19

Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results from infection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 is not only a short-term infection but that patients (pts) recovering from SARS-COV2 infection complain of persisting symptoms including: fatigue, diffuse myalgia and weakness, which may lead to chronic fatigue syndrome. There is currently no evidence that nutritional supplements and/or physical exercise can assist in the recovery of pts with chronic fatigue syndrome. 1-Methylnicotinamide (1-MNA) is an endogenic substance that is produced in the liver when nicotinic acid is metabolized. 1-MNA demonstrates anti-inflammatory and anti-thrombotic properties. Therefore, we investigated whether 1-MNA supplements could improve exercise tolerance and decrease fatigue among patients recovering from SARS-COV-2.

The study population was composed of pts after COVID-19, expressing subjective feelings of limited tolerance to exercise. The selected pts were randomized into two groups: GrM0 - without supplementation; GrM1 - with 1-MNA supplementation. At the beginning of the study (Phase 0), in both groups, a 6-minute walk test (6MWT) was carried out and fatigue assessment with Fatigue Severity Scale (FSS) was performed. After 1 month (Phase 1), a fol-low up FSS and 6MWT once more were performed in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients after COVID-19
* Patients expressing subjective feelings of limited tolerance to exercise and above 50% greater fatigue compared to their pre-COVID-19 levels (symptoms must have continued for at least four weeks since the last symptoms of infection)

Exclusion Criteria:

* Patients with cardiological complications
* Patients with pulmonological complications
* Patients with Chronic Obstructive Pulmonary Disease and/or asthma
Tobacco Cessation Intervention

This study is planned as an evaluation of a low cost, simple smoking cessation intervention. There is very little information about the effectiveness of a simple tobacco cessation strategy. Therefore, our objective is to obtain estimates of effectiveness that can be used to refine existing programs or to develop new ones.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and read English

Exclusion Criteria:

* Currently undergoing tobacco cessation treatment
Resin Infiltration to Arrest Early Tooth Decay

The purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay.

A 3-year prospective, randomized control clinical trial (RCT) is designed incorporating a split mouth intra-oral design. Young volunteers (18-24 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by resin infiltration therapy as adjunct to standard-of-care preventative measures. Lesion status (non-cavitated) is clinically confirmed prior to implementing the assigned therapy.

Eligibility Criteria:
Inclusion Criteria:

* DMFT ≥ 3 (DMFT = index of decayed-missing-filled permanent teeth)
* Having at least two early caries lesions in approximal posterior tooth surfaces
* Lesions visible on radiograph

Exclusion Criteria:

* Current participation in another clinical study
* Medically compromised subjects
* Hyposalivation
* Pregnancy
* Allergic to methylmethacrylates
* Allergic to latex
* Symptomatic teeth
Radial Shockwave Versus Ultrasound Phonophoresis

Comparative study to compare the effect of radial shockwave versus ultrasound phonophoresis in management of chronic supraspinatus tendinitis consists of 3 groups exp1(shockwave treatment + conventional physical therapy) , exp2( ultrasound phonophoresis+ conventional physical therapy) and control group ( conventional physical therapy)


Eligibility Criteria:
Inclusion Criteria:- BMI 18.5-24.9

* 18 years to 60
* with Unilateral Chronic Supraspinatus Tendinitis.
* Tenderness is found over the supraspinatus as it passes sub-acrominal and anterolateral.
* The patient reported with positive Jobe's test (empty can test)
* The patient reported pain with active shoulder elevation in the scapular plane (eg: welders, plate workers, slaughterhouse workers and overhead playing athletes).
* The patient reported pain with resisted isometric abduction

Exclusion Criteria:

* Case reports, treatments after surgery, did not meet our specified outcome parameters, traumatic incidents,
* Partial tears at surgery
* Massive retracted tears at surgery
* Frozen shoulder.
* Rotator cuff tear.
* Glenohumeral or acromioclavicular arthritis
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a mean sitting Diastolic Blood Pressure (msDBP) ≥ 95 mmHg and \< 110 mmHg at Visits 1 and 2
* Patients who have been treated for hypertension within the 4 weeks prior to - Visit 1 must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 2
* All patients must have a msDBP ≥ 90 mmHg and \< 110 mmHg at Visit 4

Exclusion Criteria:

* Severe hypertension
* Pregnant or nursing (lactating) women
* Women of child-bearing potential
* Previous or current diagnosis of heart failure New York Heart Association (NYHA Class II-IV)
* Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
* Uncontrolled Type 1 or Type 2 diabetes mellitus
* Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
* History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention

Other protocol-defined inclusion/exclusion criteria may apply.