cyrilzakka/clinical-trials huggingface dataset:
One Anastomosis Gastric Bypass for Severe Obesity in 6,722 Patients: Early Outcomes From the Assuta Surgery Registry

Background: One-anastomosis gastric bypass (OAGB) is an emerging type of bariatric metabolic surgery (BMS). Our study aimed to evaluate the short-term (≤30-day) postoperative safety of OAGB.

Methods: Electronic medical records of all OAGBs performed between January 2017 and December 2021 at a high-volume bariatric center in Israel were scanned using the MDClone software. Data regarding patients' characteristics, surgical procedure, ≤30-day postoperative complications, and their classification according to Clavien-Dindo grade were gathered. Moreover, multivariate logistic regression analysis was used to identify factors related to early postoperative complications after OAGB.

Results: A total of 6,722 patients underwent a primary (74.1%) or revisional (25.9%) OAGB procedure at our institution during the study period. Their preoperative mean age and body mass index (BMI) were 40.6±11.5 years and 41.2±4.6 kg/m2, respectively, and 75.0% were females. Respective mean operating time and length of stay were 67.3±26.6 minutes and 2.2±1.4 days. Complications occurred in 258 patients (3.8%), and include mainly bleeding (n=133, 2.0%), leaks (n=32, 0.5%), and obstruction/strictures (n=19, 0.3%). According to Clavien-Dindo classification, complication rate for grades 1-2 and grades 3a-5 were 1.6%; and 1.4%, respectively. The mortality rate was 0.03% (n=2). The rate of readmission and reoperation were 1.9% and 0.9%, respectively. Age ≥60 years, ≥3 hours of operating room time, and cholecystectomy concomitant with OAGB were independent predictors of early post-OAGB complications.

Conclusions: OAGB was found to be a safe primary and revisional BMS procedure in the ≤30-day postoperative term. The most common early complications were gastrointestinal bleeding (2.0%), leak (0.5%), and stricture (0.3%).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old, patients who received approval to undergo Bariatric and Metabolic Surgery by Assuta Medical Centers' bariatric committee, patients who have undergone primary or revisional OAGB surgery at ABCs, and patients who had complete follow-up data of 30-day post-procedure.

Exclusion Criteria: Age ≤ 18 years old

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Effect of New Topical Preparation for Treatment of Acne Vulgaris

The investigators propose a randomized, double-blind control trial study to evaluate the efficacy and safety of the optimized topical combination ME of the investigated drugs in the treatment of acne vulgaris containing DAP-FLU in comparison with standard therapy of Adapalene at Mansoura University Dermatology and Andrology Outpatient Clinic.


Eligibility Criteria:
Inclusion Criteria:

1. Male and females age 12 or older
2. Clinical diagnosis of mild to moderate facial acne vulgaris defined as:

   1. ≥ 5 inflammatory lesions, and;
   2. ≥ 10 non-inflammatory lesions, and;
   3. IGA 2-3
3. Willing to refrain from using any treatments, other than the investigational product, for acne present on the face. This includes the use of antibiotics for the treatment of acne.
4. Willing and able to provide informed consent and to comply with the study protocol.

Exclusion Criteria:

1. Women were excluded if they were pregnant, nursing, or planning a pregnancy as were men with facial hair that would interfere with the assessments.
2. Continuous or planned use of tanning booths or excessive sun exposure, in the opinion of the Investigator.
3. Treatment with systemic corticosteroids within 28 days prior to baseline.
4. Two or more active nodular lesions.
5. Use of androgen receptor blockers (such as spironolactone or flutamide) in the 7 days prior to randomization.
Open-label Placebo in Manual Therapy

to investigate the effects of placebo in patients affected by low-back pain.


Eligibility Criteria:
Inclusion Criteria:

Adult patients (+18 years) who complain of chronic non-specific low back pain for at least 3 months with or without pain exacerbations at the time of recruitment, will be included.

-Patients will need to have a diagnosis of low back pain made by a physician

Exclusion Criteria:

* pathologies such as ankylosing spondylitis, infections, fractures, tumors or metastases.
* Pregnant women
* patients with previous spinal surgery or undergoing cortisone therapy in the 6 months prior to the trial
* diseases that may affect the interpretation of results such as fibromyalgia
* patients currently being treated by other specialists or other manual therapists
Study of Postoperative Delirium in Elderly People After Orthopedic Surgery

The purpose of this study is to investigate the possible relationship of microRNA and postoperative delirium.

Postoperative delirium is one of the most common postoperative complications in elderly patients.It has been shown that postoperative delirium has independent adverse effects on short and long-term mortality and morbidity, including poor functional recovery, postoperative cognitive dysfunction, deterioration in quality of life, and increased costs. However, at the present time, postoperative delirium is a clinical phenomenon, and its neuropathogenesis remains unknown. This gap in knowledge has become a barrier that limits further studies, including the development of potential interventions for postoperative delirium.

Eligibility Criteria:
Inclusion Criteria:

1. 65 years old or older
2. candidates for spinal anesthesia
3. Non language communication barriers

Exclusion Criteria:

1. past medical history of neurological and psychiatric diseases including AD, other forms of dementia, stroke, or psychosis;
2. severe visual or hearing impairment;
3. unwillingness to comply with the protocol or procedures.
Validation of a Frailty Self Assessment Tool

The number of elderly is increasing throughout of the world. Aging is associated with increasing diseases that may be preventable. Over the last decades, frailty has emerged as one of the major risk factors for loss of autonomy. Frailty can be reversed through appropriate interventions particularly when they are implemented early. Therefore, early detection of frailty is a major objective. The goal of this study is to identify elderly subjects aged 70 years and over at the early stage of frailty by using a self administered questionnaire sent to the participant by mail. The results of the self assessment will be compared to the Fried criteria collected by a clinical examination conducted by a healthcare Professional blinded to the self assessment results.

Five thousands (5000) retirees aged 70 and over will be randomly selected from National Retirement Pension Institute (CNAV) retirees (2500 living in Paris and 2500 living in Toulouse). They will receive a letter from the CNAV explaining the study approach and a separate self-assessment frailty questionnaire to be filled in by the retirees at home and sent back in a pre-paid envelope to International Longevity Centre France (ILC-France).

Retirees who have accepted the home assessment are examined by a healthcare professional, blinded to the results of self-administered questionnaire, using the Fried's frailty criteria in order to confirm or infirm the diagnosis of frailty.

The General practitioner will be informed of the investigation results in order to set up a personalized prevention plan.

ILC-France will anonymize both the self-administered questionnaires and the Fried assessments and send them to the Mixed Research Unit (UMR) 1027 in Toulouse.

Comparison of the Fried assessment results with those of the self-questionnaire will confirm the metrological characteristics (false negative, false positive, sensitivity, specificity, predictive value) of the questionnaire.

Secondary analyses will be conducted to compare the prevalence of frailty by age and gender.

The statistical analysis is carried out by the UMR 1027 of Toulouse.

Eligibility Criteria:
Inclusion Criteria:

* Retirees from the National Old-Age Insurance Fund
* Aged 70 or older,
* Living at home
* Representatives of the general population

Exclusion Criteria:

* Institutionalized retirees
* Retirees receiving the Personalised Allowance for Autonomy
* Retirees who enrolled in previous studies
Hong Kong and Taiwan HM3 PMS

Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will enroll approximately 30 patients, that meet the HM3 commercially approved labelling indications, from approximately 4 sites in Hong Kong and Taiwan. PMS participants will be followed until the 24 months follow-up visit or until they experience an outcome, whichever comes first.


Eligibility Criteria:
Inclusion Criteria:

- All patients at the participating sites that are determined to meet the HM3 commercially approved labelling indication and have a planned HM3 implant are eligible to participate in this PMS. Assessment for eligibility criteria is based on medical records of the site and interview with a candidate patient.

Exclusion Criteria: None
Pathogenic Microorganisms in Adult Severe Pneumonia Patients

This study aimed to evaluate pathogenic microorganisms in adult severe pneumonia patients in different cities of Liaoning Province

The pathogenic microorganisms of adult patients with severe pneumonia is detected in this study. Clinical treatment does not involve , so it meets the ethical requirements. The clinical data, laboratory test results and imaging data of adult severe pneumonia patients in different hospitals in different cities are recorded. The pathogenic microorganism is detected by second-generation sequencing of lower respiratory tract sputum or alveolar lavage fluid samples, and the data were sorted out to draw the pathogenic microorganism spectrum of adult severe pneumonia in Liaoning area. It will be used to guide clinical empirical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meet the standard of severe pneumonia： Main standards： Requiring mechanical ventilation or septic shock requiring vasoconstrictor therapy.

Secondary standards：(only if 3 items are met) Disturbance of consciousness; respiratory rate ≥ 30 times/min; PaO2/FiO2 ≤ 250, or PaO2 \< 60mmHg; azotemia (BUN ≥ 7.12mmol / L); hypotension requires strong fluid resuscitation; infiltration of multiple lobes; leucopenia (WBC \< 4 × 109 / L); thrombocytopenia (\< 10 × 109 / L); hypothermia (T \< 36 ℃).

Exclusion Criteria:

* refuse to sign informed consent; inaccurate results due to unqualified sputum or BALF samples
Analysis of the Vascular Pattern of the Superficial Temporal Artery

Retrospective analysis to the course and branching pattern as well as surgically relevant inner diameters and lengths of the superficial temporal artery (STA) by digital subtraction angiographies (DSA).


Eligibility Criteria:
Inclusion Criteria:

* good quality digital subtractions angiographies of the STA

Exclusion Criteria:

* bad quality digital subtractions angiographies of the STA
Diagnostic Validation of Wearable ECG Monitoring Patch, ATP-C120

A new wearable patch-type device, ATP-C120 (ATsens, Seongnam, Korea) is a novel, single-lead ECG monitoring device and can continuously monitor the ECG signal for upto 11 days. This study is designed to experiment its diagnostic capability of new-onset atrial fibrillation in high risk patients. Several studies reported that validated CHA2DS2-VASc score has high performance in predicting new-onset atrial fibrillation and there are over 10 percent of new-onset atrial fibrillation in patients whose calculated CHA2DS2-VASc scores are ≥ 2. Thus, through this study, the investigators sought to evaluate the validation of early detection of new-onset atrial fibrillation by ATP-C120.

The prevention of stroke associated with atrial fibrillation is a leading global health concern. This devastating event is largely preventable with anticoagulant therapy. Therefore, the early detection and accurate diagnosis of arrhythmia are crucial for prevention of adverse outcome. However, because atrial fibrillation is often intermittent and mostly asymptomatic, it is difficult to capture an excise event.

Conventional electrocardiogram (ECG) monitoring devices including multi-lead portable ECG monitoring device, event-detection monitoring device, and implantable ECG monitoring device are useful for early detection of atrial fibrillation, but these devices have various drawbacks such as requirement of multiple out-patient visits and need of invasive implantation of devices.

A new wearable patch-type device, ATP-C120 (ATsens, Seongnam, Korea) is a novel, single-lead ECG monitoring device and can continuously monitor the ECG signal for upto 11 days. It has recently demonstrated its diagnostic capability and safety compared to the conventional ECG monitoring systems . Yet, it has not widely used in real-world. So, this study is designed to experiment its diagnostic capability of new-onset atrial fibrillation in high risk patients. Several studies reported that validated CHA2DS2-VASc score has high performance in predicting new-onset atrial fibrillation and there are over 10 percent of new-onset atrial fibrillation in patients whose calculated CHA2DS2-VASc scores are ≥ 2. Thus, through this study, the investigators sought to evaluate the validation of early detection of new-onset atrial fibrillation by ATP-C120.

Eligibility Criteria:
Inclusion Criteria:

1. patients who provide written and informed consent to participate
2. patients whose calculated CHA2DS2-VASc score is ≥ 2

Exclusion Criteria:

1. subjects previously diagnosed with atrial fibrillation
2. subjects implanted pacemaker, cardioverter-defibrillator, or any electrical devices
3. subjects had skin problems such as allergic contact dermatitis
4. female patients who are pregnant, or lactating status.
Efficacy of Deep Cervical Flexor Muscles Training on Neck Pain, Functional Disability and Muscle Endurance in School Teachers

Neck pain (NP) is a common work related disorder. Teaching is one profession in which its prevalence is high. The Daily job of a school teacher involves head down posture while reading, writing, etc., exposing them to risk of developing NP. Deep cervical flexor (DCF) muscles have been shown to have lower endurance in patients with cervical impairment which has been associated with disability. There is limited evidence that reports efficacy of DCF muscles training in occupational NP. This study was done to see the effect of DCF muscles training using pressure biofeedback on pain, muscle endurance and functional disability in school teachers with NP.

Neck pain (NP) is a common work related disorder. Teaching is one profession in which its prevalence is high. The Daily job of a school teacher involves head down posture while reading, writing, etc., exposing them to risk of developing NP. Deep cervical flexor (DCF) muscles have been shown to have lower endurance in patients with cervical impairment which has been associated with disability. There is limited evidence that reports efficacy of DCF muscles training in occupational NP. This study was done to see the effect of DCF muscles training using pressure biofeedback on pain, muscle endurance and functional disability in school teachers with NP. 65 teachers, aged between 25 to 45 years with experience of more than 5 years were agreed to participate in this study. Subjects were randomly divided into two groups, experimental (EG) and control group (CG). In EG, subjects received DCF muscles training using pressure biofeedback in addition to conventional exercises for neck pain while in CG subjects received only conventional exercises. Pain, muscle endurance and disability measured at day 0 (before treatment), day 14 and day 42 after treatment. Endurance of DCF muscles was measured by CCF test using pressure biofeedback instrument, Pain intensity was measured using NPRS and Functional disability was assessed using NDI questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* experience of more than 5 years
* neck pain score of more than 5 on numeric pain rating scale (NPRS), mild to moderate disability score on neck disability index (NDI) and poor cranio-cervical flexion (CCF) test

Exclusion Criteria:

* any neurological sign or symptom, history of spinal surgery or if they were taking any treatment for their pain.
Effects of Vitamin D on Inflammation in Liver Disease

Chronic liver diseases are associated with inflammation. The investigators postulate that Vitamin D may modulate inflammation. Thus the investigators will study the effect of Vitamin D replacement in patients with Hepatitis C infection and Vitamin D deficiency.

Vitamin D appears to be a critical signaling molecule for macrophages because is needed for activation and differentiation of monocytes/macrophages. From our Preliminary Studies( VA Merit Review Grant), we propose that Vitamin D deficiency may alter the 'pro-inflammatory' ('classically activated') M1 macrophages , characterized by i\] high expression of NOS2, TNF-a, IL-1, IL-6, IL-8, TGF-a, CXCL10, and CCL19; and ii\] minimal expression of arginase 1 and mannose R.

The clinical relevance of these findings is suggested by the presence of activated M1 macrophages in liver biopsies from patients with severe drug-induced liver injury (unpublished observations).

Prospective vitamin D supplementation studies with appropriate endpoints are needed to define the role of vitamin D on inflammation in patients with chronic liver diseases.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 or older
* Total 25-OH Vit D \< 25 ng/mL
* Infection with HCV genotype 1 (subjects infected with multiple genotypes are not eligible).
* Plasma HCV RNA concentration of \>100,000 IU/mL.
* HCV-infected subjects naïve to treatment: subjects who either have never been treated for HCV infection or who previously received HCV treatment ending \> 3 months prior to enrollment (including, any IFN-Alpha with or without ribavirin, or other anti-HCV antiviral medication).

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Patients with Sarcoidosis, Histoplasmosis, Lymphoma, Primary Hyperparathyroidism or Idiophatic Hypercalcemia.
* Liver Cirrhosis.
* Known active gastrointestinal disease that could interfere with the absorption of the test article.
* Laboratory determinations at screening as follows:
* Hemoglobin \<10 g/dL .
* Serum creatinine that is not within normal limits. However, such subjects may be enrolled if the Cockroft-Gault glomerular filtration rate (GFR) is \> 50 mL/minute.
* Unstable hypertension, cardiac disease or type 2 diabetes requiring changes in treatment with medications 4 weeks prior to screening or during the screening period.
* Use of an investigational drug within 4 weeks before the screening visit or during the screening period.
* Use of systemic immunosuppressants (including systemic, oral, or intravenous corticosteroids) or immunomodulating agents within 4 weeks before the screening visit or during the screening period.
Study of Xeloxiri Regimen for Patients With Refractory Metastatic Colorectal Cancer

This is an open-label, single centre, single-arm phase II study which aims to assess the efficacy and tolerability of triplet combination of capecitabine, oxaliplatin and irinotecan (Xeloxiri regimen) in treating patients with refractory metastatic colorectal cancer. Clinical data from patients diagnosed with colorectal cancer will be collected and analyzed in this study. The patients' data will be collected and maintained in the Division of medical oncology of the Department of Medicine, Queen Mary Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age, male or female.
* Histopathologically or cytologically confirmed adenocarcinoma.
* Failed ≥ 2 lines of standard therapy which must include a fluoropyrimidine, oxaliplatin and/or irinotecan, administered either as monotherapy or doublets.
* ECOG performance status 0 to 2.
* Adequate bone marrow reserve.
* Absolute neutrophil count \> 1 × 109/L.
* Total bilirubin \< 3 × the upper limit of the normal range.
* Life expectancy ≥ 12 weeks.
* Signed written informed consent form.

Exclusion Criteria:

* Prior malignant disease other than colorectal cancer within 5 years of study entry.
* Patients suitable for surgical or locoregional therapies.
* Patients unable to swallow oral medications.
* Any evidence of brain metastasis (unless the patient is \>6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry).
* Active clinically serious infections (\> grade 2 NCI / CTC Adverse Event version 3.0).
* History of allergy to platinum compounds.
* Patients who have chronic inflammatory bowel disease and/or bowel obstruction.
* Patients who have severe bone marrow failure.
* Patients undergoing renal dialysis.
* History of HIV infection.
* Seizure disorder requiring medication (such as steroids or anti-epileptics).
* Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.