cyrilzakka/clinical-trials huggingface dataset:
Characteristics of Papez Loop Neural Network in T2DM （Type 2 Diabetes Mellitus）

This is a cross-sectional and longitudinal study to investigate the characteristic changes in Papez's circuit neural network activity and connectivity based on multimodal MRI, and through follow-up study of the interaction between the internal brain regions of Papez circuit and the function of the external neural network, a prediction model of the characteristic changes of Papez circuit neural network was constructed based on machine learning technology.

T2DM patients may have multidimensional cognitive impairment, which is related to the damage of key brain regions in Papez's circuit. The purpose of this study is to establish a prediction model for the occurrence, development, and severity of cognitive impairment by using machine learning of Papez circuit neural network in T2DM patients. This will allow for early intelligent assessment with high accuracy and efficiency, and assist in clinical personalized treatment and early intervention. The research center has 1 principal investigator, 4 sub-investigators, and 1 nurse. Participants will include 200 patients with type 2 diabetes recruited from outpatient and inpatient departments. Additionally, 200 healthy controls will be recruited from the community. Each subject will undergo clinical information collection, biochemical measurements including fasting blood glucose, C-peptide, HbA1c, blood lipid, postprandial blood glucose, and postprandial C-peptide, multimodal MRI scans, and cognitive assessments at baseline and each follow-up visit. The study duration is 6 years, with a follow-up every 36 months. At the end of the study, all assessments will be performed again for all recruited subjects.

Eligibility Criteria:
Inclusion Criteria:

1. T2DM patients met the diagnostic criteria for diabetes (WHO, 1999) with a duration of 3-20 years; The control group met the criteria of fasting blood glucose \< 6.1mmol/l and glycosylated hemoglobin \< 5.7%;
2. right-handed, aged 45-70 years, with ≥8 years of education;
3. no contraindications to MRI scanning such as electronic and metal device implantation;
4. The visual acuity or corrected visual acuity and binaural hearing can meet the needs of the evaluation, and can cooperate to complete the examination.
5. without a history of substance abuse or dependence, evaluation is not used during the period of calm sleeping pills and antidepressants, not long-term use of drugs to improve cognitive.

Exclusion Criteria:

1. patients with acute metabolic complications or a history of severe hypoglycemia;
2. severe heart, liver, lung, kidney and hematopoietic system diseases; Hyperthyroidism or hypothyroidism; Stroke, alzheimer's disease, epilepsy, Parkinson's disease and other neurological history; A history of mental illness such as depression, mania, or alcohol dependence; History of loss of consciousness due to neurological diseases or traumatic brain injury;
3. one month before the laboratory examination, with a record and surgical trauma infection;
Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques

This study aimed to evaluate patient satisfaction and OHRQL using two pick-up methods for locator retained mandibular overdenture


Eligibility Criteria:
Inclusion Criteria:

* 1. All selected patients will have two implants placed in the mandibular interforaminal region.

  2. All selected patients have a healthy mucosa and have no clinical complications.

  3. All patients are cooperative and approve of the proposed treatment protocol

Exclusion Criteria:

* 1. Patients who refuse to participate in the study 2.Patients who need implant placement as a result of previous implant failure
Antibacterial Photodynamic Therapy in the Management of Peri-implantitis

This early-stage study is designed to determine the efficacy of the Lumoral method in periimplantitis. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues, thus impacting osseointegration.

Clinical signs of inflammation in peri-implantitis include bleeding on probing, suppuration, increased probing depth, and radiographic signs of bone loss. Currently, the best treatment options for peri-implantitis include non-surgical methods of biofilm removal in the supra-mucosal area around implants, and comprehensive guidance on self-performed infection control procedures. With more advanced peri-implantitis, anti-infective surgical treatment protocol would be needed.

Matrix metalloproteinase 8 (MMP-8) has been found to be elevated in association with oral infections, such as periodontitis and peri-implantitis. The level of active MMP-8 (aMMP-8) can detect to determine tissue health and to assess inflammation, and can easily be measured during a regular dental appointment with a chairside test.

The Lumoral Treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The method mechanism of action is antibacterial photodynamic therapy (aPDT). The method is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

Eligibility Criteria:
Inclusion Criteria:

* PPD ≥6 mm and marginal bone loss \>3 mm
* Dental implants collected and clinically characterized according to Lähteenmäki et al. CEDR-22
* Agreement to participate in the study and to sign a written consent form
* Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol

Exclusion Criteria:

* Presence of any physical limitation or restriction that might restrict Lumoral use
* Unwilling to participate in the study
* Pregnancy or lactation
* Active smoking
* Medicated diabetes mellitus (DM)
* Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of peri-implantitis
* Use of antibiotics and doxycycline, chlorhexidine, and bisphosphonates, within 4 weeks week prior to study participation
* Peri-implant and periodontal treatment within 3 months prior to study participation
* Removable major prosthesis or major orthodontic appliance
Embolectomy in Acute SYlvian Thrombosis in Refractory or Ineligible Patients to ALteplase

This trial aims at comparing two strategies currently used to address acute ischemic stroke of the middle cerebral artery : medical treatment without endovascular treatment on the one hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of the strategies will be assessed in terms of early neurological clinical recovery.

The study will focus on three particular situations : (1) tandem internal carotid and middle cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended because of a delay superior to 4.5 hours.

The hypothesis to be tested is that medical approach plus endovascular treatment is superior to medical treatment alone


Eligibility Criteria:
Inclusion Criteria:

* Radiologically proven acute proximal occlusion of middle cerebral artery

AND one of the three following :

1. tandem internal carotid / middle cerebral artery occlusion
2. intravenous thrombolysis contraindicated because of high risk of haemorrhage
3. intravenous thrombolysis not possible because of delay \> 4.5 hours

Exclusion Criteria:

* Impossibility to perform endovascular recanalization within 6h
* Clinically minor stroke (NIHSS score below 5 at baseline)
* Extended cerebral infarction
* Severe comorbidity
* Life expectancy below 3 months before stroke
* Pregnancy or breastfeeding
* modified Rankin Score superior to 2 before stroke
A Study of Remimazolam Tosilate for Sedation in the Upper Gastrointestinal Endoscopy

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in Upper Gastrointestinal Endoscopy


Eligibility Criteria:
Inclusion Criteria:

1. patients or their guardians are able to provide a written informed consent
2. participants undergo upper gastrointestinal endoscopy
3. ≥18 years old, male or female
4. 18 kg/m2≤bmi≤30kg/m2

Exclusion Criteria:

1. Subjects to be intubated (including laryngeal mask placement);
2. Complex endoscopic diagnosis and treatment operations are required;
3. Severe cardiovascular disease within 6 months prior to signing the ICF;
4. Heart rate \< 50 beats/min during screening period;
5. Subjects with poor blood pressure control during screening;
6. Severe arrhythmias or heart disease; the circulatory system is unstable;
7. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
8. Subjects with a history of drug abuse;
9. Abnormal values of the laboratory examination;
10. Allergic to relevant drugs ingredient or component;
11. Pregnant or nursing women;
12. Subjects who has participated in clinical trials of other interventions recently;
13. Other conditions deemed unsuitable to be included.
A Study in the Treatment of Acute Mania

The purpose of this study is to test the efficacy and total costs of olanzapine versus commonly used conventional antipsychotics in Sweden.

The primary objective is to show that the efficacy of olanzapine is non-inferior to the conventional antipsychotics haloperidol or zuclopentixol in the treatment of an acute manic or mixed episode of bipolar disorder. Efficacy is defined as time to remission, as measured by the total scores of the Young Mania Rating Scale (Y-MRS), MADRS-S, and Clinical Global Impression - Bipolar (CGI-BP). Time from baseline to remission is defined as the primary efficacy measure. Remission is defined as a Y-MRS score \<=12 AND a MADRS-S score \<=12 AND CGI-BP = 1 or 2.

Secondary efficacy assessments will include time from baseline to

* Response, as defined as a reduction of Y-MRS score greater than or equal to 50% compared to baseline
* Relapse of mania, as defined as a Y-MRS score \>= 16 AND CGI-BP \>2 after having met the criteria for remission
* Switch into depression, as defined as a MADRS-S score \>=17 AND fulfilled criteria for Major Depression as self-assessed by DSRS.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar I disorder and currently display an acute manic or mixed episode (with or without psychotic features)
* Patients must have a Y-MRS total score of greater or equal to 20 at visit 2
* Patients must have experienced at least one manic or mixed episode prior to study enrollment
* Female of childbearing potential must be using a medically accepted means of contraception, or practice sexual abstinence
* Each patient must have a level of understanding sufficient to communicate intelligently with study personnel
* Patients must be considered reliable
* Each patient must understand the nature of the study and signed informed consent

Exclusion Criteria:

* Female patients who are pregnant or lactating
* Serious, unstable illnesses such that hospitalization for the disease is anticipated within 3 month or death is anticipated within 3 years
* Uncorrected hypothyroidism or hyperthyroidism
* Narrow-angle glaucoma
* History of allergic reactions or intolerance to study medications
* DSM-IV substance dependence within the past 30 days at the judgement of the investigator
* Judged clinically to be at serious suicidal risk
* Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to visit 2
* Any patient treated with clozapine within 4 weeks prior to visit 2
* Subjects who have received treatment with ECT within one month prior to visit 1
Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications

Lung adenocarcinoma in Chinese females is hypothesized to be determined by both genetic and environmental factors. In this grant proposal, we propose to map the loci of susceptibility genes of female lung adenocarcinoma based on multiplex families recruited in Taiwan. We focus on a unique pathological type of a unique population in order to reduce heterogeneity of the genetic background. Compared with western women, female Chinese population has a high prevalence of lung adenocarcinoma. Our reasoning is that if we focus on a specific sub-type, which has a familial basis, we will increase the probability of identifying genes associated with female lung adenocarcinoma. The primary goal of this study is to identify the genetic and environmental determinants of female lung adenocarcinoma, and study the relationship between gene polymorphisms and clinical manifestation profiling of lung cancer.

This research proposal intends to integrate epidemiologists, biostatisticians, clinicians, molecular biologists/geneticists to identify susceptible genes for lung cancer, especially for female lung adenocarcinoma, and to study the relationship between gene polymorphisms and clinical outcomes of lung cancer patients. Our objective is to find gene markers for developing useful screening tools for the high risk group in order to prevent or early detect lung cancer, especially female lung adenocarcinoma.

The specific aims of this subproject include:

1. Establish and maintain the research network that will recruit and follow up the subjects and families for the GEFLAC study; keeping control of the progress of the study.
2. Coordinate all the subprojects such as integrating genotyping data with clinical data and environment data.
3. Continue to employ the candidate gene approach to examine the contribution of specific genes to the lung cancer.
4. Generate genotyping data for candidate genes in the exploring stage and prioritize SNPs of candidate genes for large scale studies.
5. Identify susceptible genes/candidate genes to develop multiplex PCR for screening.

Eligibility Criteria:
Inclusion Criteria:

* lung adenocarcinoma

Exclusion Criteria:

-
HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients

Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients includes chronic administration of nucleos(t)ide analogues (NUC) or pegylated interferon (PegIFN) during 12 months. Typically, PegIFN allows immune control of CHB and antigen "s" (HBsAg) loss in around 4% of patients compared to less than 0,1% using NUC. Recently, it has been described that HBsAg quantification (HBsAg-q) is useful to identify patients with high probability to lose HBsAg during follow-up. In addition, a proof-of-concept study with nine HBeAg-negative patients receiving NUC showed that adding PegIFN (16 weeks) achieved HBsAg loss in one patient (11%). The aim of our study is to evaluate the efficacy and safety adding PegIFN (48 weeks) in treated HBeAg-negative patients with NUC.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B (HBeAg-negative)
* Signed inform consent
* Aged \> 18

Exclusion Criteria:

* Contraindications for Pegylated interferon (cirrhosis, pregnancy, others)
* Previous treatment with interferon or Pegylated interferon
* Previous HBsAg loss
* Treatment duration with Nucleos(t)ide analogues less than 2 years
* Poor adherence to Nucleos(t)ide analogues
The Results of Total Hip Arthroplasty in Crowe Type 4 Hips.

Total hip arthroplasty (THA) performed for developmental dysplasia of the hip (DDH) is a technically difficult procedure with a high complication rate, especially in the presence of completely dislocated hips. This study aimed to evaluate the results of at least 10 years of follow-up results of cementless, ceramic-on-ceramic (CoC) total hip arthroplasty performed with transverse subtrochanteric osteotomy in Crowe type 4 hips.

We reviewed retrospectively 67 hips of 50 patients which underwent CoC, cementless THA with transverse subtrochanteric osteotomy between 2008 and 2011. Clinical and radiological data of the hips were examined. Clinical results were evaluated using the Harris Hip Score (HHS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Eligibility Criteria:
Inclusion Criteria:

Crowe type 4 developmental dysplasia of the hip

Exclusion Criteria:

Primary Coxarthrosis
A Phase 4 Clinical Study of Brodalumab

This study \[4827-005 (post market)\] is designed to evaluate the safety and efficacy of long-term exposure to brodalumab in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic arthritis) who have completed Study 4827-003 (Study 003) and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004). 4827-005 study was conducted as phase 3 clinical trial until July 4th 2016 (approval date in Japan). After that date 4827-005 study was switched to phase 4 study.


Eligibility Criteria:
Inclusion Criteria:

* Subject has voluntarily signed the written informed consent form to participate in this study
* Subject has completed the study 4827-005 (phase 3)

Exclusion Criteria:

* Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
* Subject has been judged to be ineligible for participation in the study by the investigators/sub investigators
Causes of Death in Follicular Lymphoma: a Single Center Retrospective Analysis

Background.Although the life expectancy of patients with FL has recently increased, notably since the introduction of rituximab in combination with chemotherapy, little is known regarding the precise causes of patients death. Patients and methods'. This study describes the different causes of death in FL patients among followed since 2000 at Lyon University Hospital, centre Léon Bérard and Mayo Clinic. The causes of death will be classified as related to lymphoma progression, treatment-related toxicity (including TRM and secondary myelodysplastic syndrome/acute myeloid leukemia), secondary neoplasias, or other.


Eligibility Criteria:
Inclusion Criteria:

* FL patients
* patients recorded as deceased

Exclusion Criteria:

-Other diagnosis than FL
Clinical Trial of the TQB3602 Capsule Combined With AK105 Injection in Patients With Advanced Cancers

TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-programmed cell death protein 1 (PD-1) antibody.


Eligibility Criteria:
Inclusion Criteria:

* 1 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
* 2 Age ≥ 18; Eastern Cooperative Oncology Group perfomance status score: 0-2; at least 3 months expected survival period.
* 3 Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and / or cytology, lack of conventional effective treatment methods, failure or relapse after treatment.
* 4 Resolved acute effects of any prior therapy to baseline severity or Grade ≤ 1 per CTCAE v5.0 except for AEs not constituting a safety risk by investigator judgment.
* 5 Must have adequate organ and bone marrow function.
* 6 Male and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective method(s) of contraception throughout the study and for at least 6 months after the last dose of assigned treatment.

Exclusion Criteria:

* 1 Subjects with other malignancies currently or suffered within 3 years. The following two conditions can be enrolled: other malignant tumors treated with a single operation to achieve disease-free survival (DFS) for 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors\[ Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
* 2 Sujects with multiple factors affecting oral administration；
* 3 Subjets with unhealed toxicity above Grade 1 Common Terminology Criteria for Adverse Events Version 5.0 due to previous antitumor treatment；
* 4 Subjects who have received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before first administration；
* 5 Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first administration.
Single-used Versus MultiPlE-used Endotracheal suCtIon cAtheters in Mechanically ventiLated ICU Patients

In low and middle-income countries, open endotracheal suction catheters are used multiple times to perform suctioning due to limited resources \[1,2\]. Currently, there is limited evidence for using a new suction catheter for each suction pass, acknowledged in a review article of endotracheal suction procedures in paediatric populations \[3\]. Additionally, the latest artificial airway suctioning practice guidelines published by the American Association for Respiratory Care in 2022 did not mention any recommendations regarding suction catheter changing frequency \[4\]. The guidelines adopted a study conducted in 2001 which showed that reusing an open tracheal suctioning catheter is safe and cost effective \[5\]. Therefore, the current evidence of reusing suctioning catheters remains unclear, which rationalize the reason why some resource limited Intensive Care Units (ICUs) use the catheter multiple times during a 12-hour shift, and possibly explain the high ventilator associated pneumonia (VAP) incidence in these ICUs \[1,2\].

Therefore, this feasibility study will propose to explore whether single-used suction catheters or multiple used open endotracheal tracheal suctioning catheters flushed with chlorhexidine are associated with reduced VAP incidence and its impact on mechanically ventilated patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged ≥ 18 years old) who are admitted to the ICU, intubated with an endotracheal tube and receiving mechanical ventilation support directly after intubation with an expected mechanical ventilation support of at least 48 hours.
* All adults' patients meeting the above criteria whose relatives agree for them to be part of the study via deferred consent process

Exclusion Criteria:

* Patients who have received already standard care at ICU admission (the use of an endotracheal suction catheter multiple times during endotracheal suction procedures)
* Patients with contraindications to endotracheal suctioning procedure such as increased intracranial pressure, severe haemoptysis, and cerebrospinal fluid leaks.
* Patients who are previously intubated during the current hospital admission.
* Patients expected to receive mechanical ventilation less than 72 hours.
* Patients diagnosed with pneumonia at ICU admission.
* Patients having a Modified Clinical Pulmonary Infection Score (MCPIS) of 5 or greater.
* Patients with atelectasis, ARDS, and pulmonary oedema.
* Patients known to be allergic to chlorhexidine.
* Patients whose family (next-of-kin) have not provided deferred consent within 48 hours after ICU admission will be excluded and standard care will be provided.