cyrilzakka/clinical-trials huggingface dataset:
Analysis of Early Healing of Sutures in Periodontal Surgery

The main objective is to analyze post-surgical periodontal healing after conventional periodontal surgery where an absorbable suture coated with clorhexidine (Novosyn Clorhexidine) versus conventional sutures without chlorhexidine (Novosyn) will be used a pilot randomized clinical study has been designed.

Up to authors´ knowledge until now there are no studies to evaluate periodontal healing after periodontal surgery in combination with this kind of sutures.

A total of 60 patients will be included, where the unit of study will be each stitch, among the patients attending the Dental Clinic Service of the University of the Basque Country (UPV/EHU) who require surgical periodontal treatment.

The patients will be randomly divided into two groups: the control group using a conventional suture (n=30), and the test group using a suture coated with chlorhexidine diacetate (n=30).

Suture in the control group: absorbable suture of polyglactin 910 coated with polyglactin 370 + calcium stearate without chlorhexidine (NOVOSYN) Suture in the test group: absorbable suture of polyglactin 910 coated with polyglactin 370 + calcium stearate and chlorhexidine diacetate (NOVOSYN CHLORHEXIDINE) The primary variable in this study is post-surgical healing in both groups, which will be assessed using the healing index.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years-old
* Patients who have completed the basic periodontal phase and require surgical periodontal treatment for periodontal disease control.
* Plaque index (O'Leary et al.,1972) ≤20%.
* Bleeding index (Ainamo \& Bay,1975) ≤20%.

Exclusion Criteria:

* Patients with systemic conditions contraindicating surgery
* Patients with allergy to chlorhexidine and/or o-cymen-5-ol
* Patients allergic to non-steroidal anti-inflammatory drugs (NSAIDs)
* Pregnant or breastfeeding women
* Patients with periodontal defects requiring regenerative surgery or mucogingival surgery/periodontal plastic therapy
* Patients who have taken antibiotics in the last 3months
Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for diagnosis of sleep apnea in human subjects. This includes evaluation of Somnarus technology in Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), including Cheyne - Stokes respiration (CSR).

This is a multi- center, open label study to evaluate the accuracy of Somnarus device when compared with overnight polysomnographic measurements.

The study includes the following steps:

Screening the database or advertising among cardiologists, neurologists, pulmonologists and Ear Nose and Throat (ENT) specialists to identify potential subjects.

Initial visit, includes:

1. Consent discussion and signature
2. History, vital signs, and physical exam

Night study

a. A polysomnogram is conducted and, at the same time, a SomnaPatch device is used.

Additional visits If side effects occur, or if the data collection fails, or at the request of the sponsor to repeat the sleep study for further data collection and comparison.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign the informed consent
* Able to comply with visits and follow ups included in this protocol
* Ages 20-85 years

Exclusion Criteria:

* An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.
* Skin rash on the nose or on the maxillary area.
* A history of skin allergy to medical tape, and hypoallergenic tapes.
* A history of skin cancer on the nose or on the maxillary area.
* A history of the base of skull fractures, facial fractures
Perioperative Factors and Living Donor Liver Transplantation

Liver transplant surgery is one of the treatments provided to patients suffering from end-stage liver disease, and has a successful treatment prognosis. However, it is clear that patient management before, during, and after surgery is a difficult task for medical staff due to the complex clinical and pathological problems of end-stage liver disease. Moreover, the complex surgical technique of the liver transplant surgery itself and the severe hemodynamic fluctuations and multi-organ dysfunction that patients experience during the surgery have been shown to have a tremendous impact on the patient's prognosis after surgery.

A study on which clinical, laboratory, and hemodynamic factors experienced by patients during the perioperative period, including before, during, and after surgery, affect the survival rate of patients and transplanted organs. will definitely be helpful in the treatment of patients suffering from end-stage liver disease.


Eligibility Criteria:
Inclusion Criteria:

* adults
* elective surgery
* American Society of Anesthesiologists (ASA) physical status classification system I, II, III

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status classification system IV, V
Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis

The prevalence of atopic dermatitis has increased along with urbanization and biodiversity loss. According to biodiversity hypothesis, the main reason is urban lifestyle and reduced contact to microbial diversity. Previous studies indicate association between atopic dermatitis and exposure to natural microbes in childhood.

Sand Play - the Effect of Biodiversity Exposure on Atopic Dermatitis will investigate whether the exposure to microbial diversity in sandbox reduces the symptoms of atopic dermatitis, alters commensal microbiota and modifies immune regulation in children.

Our specific aims are:

To assess if exposure to microbial diversity reduces Eczema Area and Severity Index (EASI) and Patient-Oriented Eczema Measure (POEM).

Assess whether the sand play alters plasma cytokine profiles, white blood cell distributions, allergy specific IgE, and commensal microbial communities on skin, in saliva and gut.

The investigators will recruit approximately 80 (40 study subjects per treatment) subjects with atopic dermatitis and aged between 2-5.

Eligibility Criteria:
Inclusion Criteria:

* Eczema Area and Severity Index ≥ 2

Exclusion Criteria:

* Eczema Area and Severity Index \< 2
* Immune deficiencies, i.e., antibody deficiency
* Immunosuppressive systematic medications
* A disease affecting immune response (e.g., colitis ulcerosa, rheumatoid arthritis, Crohn's disease, diabetes)
* Cancer diagnosis
* Topical medication for the treatment of atopic dermatitis during the trial
* Disability affecting the immune response (e.g. Down's syndrome)
* Non-participation in the national vaccine program
* Participation in another intervention or follow-up study
Development of a Decision-making Aid for Referring Severe Kidney Injury Patients for Nephrology Consultations

Acute kidney injury is a frequent and growing complication associated with a risk of progressing into a chronic kidney disease. Recent guidelines have recommended systematic consultations with a nephrologist 3-6 months following hospitalization. Risk factors of developing chronic kidney disease between hospital visits are understudied.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Suffering from acute kidney injury treated with dialysis
* hospitalized in a university center from August 2016 to December 2017 with severe AKI defined according to 2 of the 3 criterion definitions of KDIGO stage AKI: an increase in SCr above 354 μmol/Lor renal replacement therapy (RRT) indication, but not the 3-fold increase in SCr increase within 7 days with SCr below 354 μmol/L.
* The patient has been informed and does not oppose the study
* The patient is insured or the beneficiary of a health insurance policy

Exclusion Criteria:

* The patients is under judicial protection or state guardianship
* Patient has chronic kidney disease(CKD) KDIGO stage 5
* It proves impossible to give the patient clear information
* patients living with kidney transplant
* plan dialysis for bilateral surgery nephrectomy
* patient refuse to participate and patients with no health insurance
Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)

This 26-week extension study evaluates the efficacy and safety of certolizumab pegol administered subcutaneously every 4 weeks (dosed at Weeks 16, 20, 24, 28 and 32) in subjects with active Crohn's disease who had no clinical response at Week 6 to induction therapy in the 6-week double-blind main study, C87037 (NCT00291668), but subsequently showed clinical response at Week 14 to repeated induction therapy (dosed at Weeks 8, 10 and 12) in this extension study.

This study is an open-label extension study which follows on from the 6-week double-blind main study C87037 (NCT00291668). All 'Week' numbers quoted are relative to the start of the double-blind main study. The first visit in this extension study is at Week 8, and the final efficacy assessment in this extension study, 26 weeks later, is at Week 34.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who gave written informed consent and who did not show clinical efficacy at Week 6 of the double-blind main study (NCT00291668) \[reduction in Crohn's Disease Activity Index (CDAI) score of ≥100 points from Week 0, or remission (CDAI ≤150)\]

Exclusion Criteria:

* Subjects who experienced aggravation of Crohn's Disease during the double-blind main study (NCT00291668) and required treatment change
Investigation of Individuals with Stroke Within the ICF Framework

The present study examined stroke patients who applied to occupational therapy units within the framework of ICF, following the rehabilitation process, and defining frequently used measurements in terms of ICF codes

The International Classification of Functioning (ICF) is a standardized method frequently used by health professionals. This follow-up study was performed in accordance with the Declaration of Helsinki. The present study examined stroke patients who applied to occupational therapy units within the framework of ICF, following the rehabilitation process, and defining frequently used measurements in terms of ICF codes. Participants were recruited from the patients who applied to the Occupational Therapy Clinic of Etlik City Hospital. Participants who agreed to participate in the study signed an informed consent form. First, the scales were defined within the framework of ICF. Individuals who had a stroke and were hospitalized in the Physiotherapy and Rehabilitation Clinic of Etlik City Hospital and included in the study were evaluated using ICF parameters within the first 3 days of their hospitalization. All individuals were given a holistic rehabilitation program. Individuals who received inpatient treatment and stayed in the hospital for one month were re-evaluated. Other individuals who were not included in the study benefited from traditional inpatient treatment services. Upon evaluating the rehabilitation service within the framework of ICF, significant changes were observed in body functions, activity, and participation. It is recommended that ICF be used by occupational therapists and other health professionals, that the scales be associated with ICF codes, and that holistic rehabilitation services be developed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stroke, age between 18 and 64 years,
* Being served by hospital, being enrolled in the occupational therapy,
* Volunteering to participate in the study

Exclusion Criteria:

* Individuals with orthopedic, psychological or neurological conditions other than stroke that could affect their functioning and those with moderate or severe aphasia were not included in the study
SMART Design to Compare Antipsychotic Treatments in Treatment-Resistant Schizophrenia

The project intends to take treatment-resistant schizophrenia as the research object and uses sequential multiple assignment randomized trial(SMART) design to define the treatment recommendations of different drug regimen for treatment resistant schizophrenia and to determine the physical enhancement regimen for clozapine-resistant schizophrenia and to explore targeted regulation scheme for ultra-resistant schizophrenia.

This trial is a sequential multiple-assignment RCT design of antipsychotic drugs, planning to recruit 162 people with treatment-resistant schizophrenia followed for 12 months. The study includes three treatment phases and a naturalistic follow-up phase. Participants who meet the response criteria remain on that treatment for the duration of 12-month treatment. If the participants fail the treatment or can't tolerant the side effects, the patient moves to the next phase of the study to receive a new treatment.

Eligibility Criteria:
Inclusion Criteria:

1. meet the DSM-5 diagnostic criteria for schizophrenia,
2. be 18-55 years of age,
3. treatment-resistant schizophrenia:no response to sufficient doses (400-600 mg/ day CPZ equivalent) of at least two antipsychotics in the past 5 years,
4. Informed consent.

Exclusion Criteria:

1. Patients with medical or psychiatric comorbidities and those who require concomitant other medications are excluded.
2. Patients with contraindications to even one of the proposed treatment arms are excluded.
3. Patients with risks such as extreme agitation, stupor or suicide are excluded.
4. Female patients with pregnancy or breast-feeding are also excluded.
LAmbre™ Left Atrial Appendage Closure System Follow-Up Study

The purpose of this study is to conduct a continuous telephone follow-up study on subjects who had completed the one-year follow-up of the LAmbre™ left atrial appendage (LAA) system registration trial. The follow-up time was 2 years, 3 years, 4 years and 5 years after left atrial appendage closure operation, to evaluate the long-term safety and effectiveness of LAmbre™ LAA Closure System.

All subjects who completed 1-year follow-up of the LAmbreTM LAA system registration trial will be conducted 2 years, 3 years, 4 years and 5 years follow-up by the telephone call.

During the follow-up, the investigator or his/her designee will use a standardized form to record the occurrence of the subject's safety events and validity endpoint by telephone，and complete the safety and efficacy summary report. The endpoints of the study included compound events, MACCE events, stroke, haemorrhage and other events.

Eligibility Criteria:
Inclusion Criteria:

- Patients who participated in the LAmbreTM Safety and Efficacy Study and completed the 1-year follow-up.

The inclusion criteria of LAmbreTM Safety and Efficacy Study:

1. Age\>=18, CHADS2 score\>=1
2. Patients cannot be treated long-term with Warfarin
3. Eligible for clopidogrel and aspirin
4. Provide written informed consent and agree to comply with the required follow-ups

Exclusion Criteria:

- Exclusion criteria: Patients who did not participate in the LAmbreTM Safety and Efficacy Study or did not complete 1-year follow-up LAmbreTM Safety and Efficacy Study.

The exclusion criteria of LAmbreTM Safety and Efficacy Study:

1. Need to take Warfarin
2. Presence of rheumatic, degenerative or congenital valvular heart diseases
3. Early stage or paroxysmal atrial fibrillation
4. Symptomatic patients with carotid artery disease (such as carotid stenosis\>=50%)
5. Heart failure NYHA grade IV
6. Recent 30 days stroke or TIA
7. Presence of active sepsis or endocarditis
8. Cardiac tumours or other malignancy with estimated life expectancy \<2 years
9. Abnormal blood test; renal dysfunction
10. LAA removed or heart implant patients
11. Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system
12. Patients have a history of mechanical prosthesis operation
13. Patients who are pregnant, or desire to be pregnant during the during the study
14. Participation in other trials
15. A known allergy to nitinol
16. Patients will not be able to complete the trial
A Study of Nipocalimab in Healthy Male and Female Participants

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of nipocalimab following subcutaneous (SC) administration compared with intravenous (IV) administration in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
* Healthy on the basis of clinical laboratory tests performed at screening
* Continuous non-smoker
* A woman of childbearing potential must have a negative pregnancy test
* It is recommended that participants are up to date on all age appropriate vaccinations prior to screening as per routine local medical guidelines

Exclusion Criteria:

* Has a history of liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Currently has a malignancy or has a history of malignancy within 3 years before screening
* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
* Has received a live vaccine within 3 months prior to screening or has a known need to receive a live vaccine during the study, or within at least 3 months after the last administration of study intervention in this study
* Shows evidence of an active or chronic hepatitis B infection
Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device.

A total of 60 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and left atrial appendage radiography, respectively (allocation ratio 1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. The diameter and depth of the left atrial appendage opening were measured by angiography in group A(ICE group), and measured by ICE in group B(radiography group). The size of the occluder device was selected according to the measurement size of the two groups, the occluder device success rate of the two groups was compared, and the relationship between measurement size and the size of the occluder device was obtained.


Eligibility Criteria:
Inclusion Criteria:

patients taking class I and class III antiarrhythmic drugs could not prevent atrial fibrillation, patients younger than 80 years old Cha2ds2-vasc score ≥2 and Has-bled score ≥3, not suitable for long-term oral anticoagulant drugs.

Exclusion Criteria:

Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases.
High Resolution Retinal Imaging

Studying the morphology and function of the normal and diseased retina in vivo is needed for advancing the detection, diagnosis, and treatment of retinal disease. This protocol uses an adaptive optics scanning laser ophthalmoscope (AOSLO) to image the normal and diseased retina with individual cellular resolution non-invasively. The primary objective of this study is to obtain and analyze high-resolution images of the retina, in particular by imaging the cone photoreceptor mosaic, the retinal vasculature and other retinal layers. The study design will involve case-control studies, where cases are followed over time. Subjects age 7 and older may be invited to participate. The main research procedure involves retinal imaging with the AOSLO. The primary endpoint is the observation of differences in retinal images between subjects with and without retinal diseases. These changes will be quantified by examining the cell density, size, spacing and regularity of the cone photoreceptor mosaic, as well as examining the differences between other retinal layers.


Eligibility Criteria:
Inclusion Criteria:

* Males or females age 7 years or older.
* Parental/guardian permission (informed consent) and if appropriate, child assent. Child subjects age 7-17 must give assent.
* Reasonable compliance with an imaging protocol as determined by the study personnel.

Exclusion Criteria:

* Individuals that are at risk to acute glaucoma.
* Individuals that are photophobic and experience adverse psychological reactions to flashes of light.
* Ocular opacities, high refractive error, and high frequency of nystagmus as determined by the study team.
Multicenter Phase I Study of HRS-6208 in Patients With Solid Tumors

This is an open, multicenter Phase I study to evaluate the safety and tolerability of HRS-6208 in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology who have relapsed or progressed after standard treatment, or have no standard treatment options, or do not apply standard treatment at this stage;
2. Age 18\~75 years old;
3. At least one measurable lesion per RECIST v1.1 criteria;
4. ECOG PS score: 0-1.

Exclusion Criteria:

1. History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
2. The adverse reactions of previous anti-tumor therapy have not recovered to NCI-CTCAE v5.0 grade evaluation ≤ 1;
3. He has severe cardiovascular and cerebrovascular diseases;
4. Severe infection within 4 weeks prior to the first dose.
Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.

This prospective and open-label study evaluates the efficacy and safety of mFOLFIRINOX as postoperative chemotherapy in treating Chinese patients with pancreatic cancer after R0/R1 resection.

The patients will be treated with systemic FOLFIRINOX chemotherapy of adjusted dosage.

Eligibility Criteria:
Inclusion Criteria:

1. Patients should be voluntary to the trial and provide with signed informed consent.
2. Histologically confirmed diagnosis of pancreatic cancer
3. Male or female, Age: 18-79 years old.
4. No recurrence or metastasis was observed from a follow-up of 4 to 8 weeks by CT scan after radical surgery.
5. the value of Carbohydrate Antigen19-9(CA19-9) \< 180U/mL within 12 weeks after surgery.
6. No previous chemotherapy
7. Eastern Cooperative Oncology Group(ECOG) performance status of 0-1
8. normal function of organ system including the followings.

   * No hematologic dysfunction(Platelets ≥90×10\^9/L; Neutrophil ≥2×109/L;Hemoglobin ≥90g/L).
   * Serum bilirubin ≤ 1.2 × upper limits of normal(ULN); aminotransferase ≤ 5 × ULN.
   * Serum creatinine ≤ 1.25× ULN, or creatinine clearance rate(CCR) ≥60mL/min(calculated by Cockcroft-Gault formula).
9. ECOG scored as 0-1.
10. Life expectancy \> 3 months.

Exclusion Criteria:

1. Patient is concurrently using other antineoplastic agent.
2. Known severe hypersensitivity to drugs in the regimen.
3. Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in situ).
4. Evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension.
5. Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.
6. Evidence of active infection or active epidemic disease.
7. Psychiatric illness that would prevent the patient from giving informed consent
8. Pregnant or lactating women.