cyrilzakka/clinical-trials huggingface dataset:
Lateral Supramalleolar Perforator Flap Reconstruction Through Branches Outside of the Ankle Tissue Defects

The lateral ankle is a common site of tissue defects and the defects in this area are often accompanied by exposure of the fibula and tendons. Microsurgical tissue transfer or a pedicled flap is needed to cover those exposures for even a relatively small defect due to the insufficiency of the local cutaneous and muscle flap in this area. Koshima et al. and Wei et al. began to propose the concept of localized perforator flaps, which were initially applied to free perforator flaps. The main benefits of such localized perforator flaps are described below.

1. It preserves vital blood vessels and the underlying muscles and fascia.
2. Complications in the donor area are rare and can be direct or partial sutures.
3. Not technically demanding, although we need to find the vessel but not the vessel junction.
4. Shorter surgery time.

There are many choices of perforator flaps for lateral ankle soft tissue defects, including lateral upper ankle flap, retrograde anterior tibial artery flap, retrograde gastrocnemius flap, etc. Among them, the lateral upper ankle flap is one of the flaps commonly used for reconstruction of lateral ankle tissue defects, and the research on the lateral upper peroneal artery perforator flap is limited.

The purpose of this study is to evaluate the clinical application of the peroneal artery perforator flap with or without split-thickness skin grafting for soft tissue reconstruction of the bony defect of the lateral malleolus of the ankle joints. Reconstruction using a peroneal artery perforator flap with or without split-thickness skin grafting was performed for 10 men and 5 women patients with defects in the lateral malleolus. The mean age was 53.7 years with the age range between 22 and 89 years, and the mean size of the flaps was 40 cm\^2. The soft tissue defects were caused by a diabetic foot (6 patients), infected bursitis (1 patient), chronic osteomyelitis (2 patients), and trauma (6 patients). Three of six diabetes mellitus patients also had peripheral arterial occlusive disease. The flaps were elevated in the form of a perforator flap, and split-thickness skin grafting was performed over the flaps and adjoining raw areas. The pedicled supramalleolar perforator flap is classified into two categories: (A) propeller and (B) rotation flaps. The mean follow-up duration was 30 months postsurgical.

Eligibility Criteria:
Inclusion Criteria:

* The subject is aged 20 years old or above (including 20 years old), regardless of gender.
* Patients with lateral ankle tissue defects

Exclusion Criteria:

* The subject is aged under 20 years old.
* Patients with tissue metabolic disorders, immune dysfunction, and drug abuse.
* Patients with severe primary diseases or mental illness such as those involving the hematopoietic system, endocrine system, etc.
* Pregnant and lactating women.
* Patient who is unwilling or unable to cooperate with the trial process or follow medical advice.
Pilot Study : FreeStyle Libre Pro Flash Continuous Glucose Monitoring System in Subjects With Diabetes on HemoDIALsis

Continuous monitoring of glucose with a FreeStyle Libre pro sensor in diabetic and dialysis patients


Eligibility Criteria:
Inclusion Criteria:

* Diabetes without any change in treatment in the last 3 months
* Hemodialysis for \> 3 months
* Recent laboratory HbA1c (\< 15 days)

Exclusion Criteria:

* Patient does not show non-opposition
* Skin allergy to the sensor
* Sepsis / Acute anaemia
The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the Recurrent Glioblastoma

This is a single arm clinical study to estimate the safety, tolerability and pharmacokinetic (PK) characteristics of Chimeric Antigen Receptor-modified T cells (CAR-T) SNC-109 in patients with recurrent glioblastoma (r-GBM) and preliminarily evaluate the effectiveness, the immunogenicity of the product, as well as their correlation between the changes of cytokines from baseline level after cellular infusion.

It is planned to recruit about 16 patients with rGBM subjects. The protocol consists of screening period, Lymphocytes apheresis period, Operation period, pre-infusion evaluation (-2\~-1 days), infusion (day 0), infusion observation (day 1-post infusion), and follow-up period (last infusion-720 days). The incidence of dose limitation toxicity (DLT) will be observed within 28 days after the first infusion. Subjects in this study will receive multiple infusions, starting with 2×104 CAR+ T cells/dose in the first subject, and the Safety Review Committee (SRC) will evaluate the subsequent dosing regimen, dose, infusion interval, and number of treatment cycles. Subsequent subjects will be evaluated by the SRC on the basis of available PK and safety data, and the SRC will determine the dosing regimen, dose, infusion interval and number of treatment cycles based on observed evidences.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤70，both sexes;
* Diagnosed with a history of glioblastoma, and the recurrent glioblastoma has confirmed by histological/molecular pathology (including astrocytoma World Health Organization (WHO) Grade 4);
* Karnofsky (KPS) ≥60;
* The estimated survival time is ≥8 weeks;
* Blood pregnancy tests for women of childbearing age are negative;
* The patient himself/herself, and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form.

Exclusion Criteria:

* Known allergies to study drugs or drugs that may be used in the study;
* Severe concurrent diseases in the heart, lungs, liver, or other vital organs;
* Hypertension is poorly controlled or accompanied by hypertensive crisis or hypertensive encephalopathy;
* In addition to the glioblastoma, with other severe central nervous system diseases or complications or aggressive malignancies;
* Long-term use of immunosuppressant drugs, or large doses of steroids;
* Received live or attenuated vaccine or other surgery had no related to GBM within 4 weeks prior to Lymphocytes apheresis;
* Lymphocytes apheresis or cell infusion combined with infection or unexplained fever.
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy.

This study consists of two periods:

1. An induction period which will test the induction of clinical remission;
2. An optional active treatment extension (ATE) period which will explore durability of clinical response and remission in which all participants will receive vixarelimab.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of UC for at least 3 months
* Moderately to severely active UC, assessed by mMS
* Inadequate response, loss of response to, or intolerance to conventional or advanced therapies for UC

Exclusion Criteria:

* Diagnosis of Crohn's disease or indeterminate colitis
* Suspicion of ischemic, radiation, microscopic, or infectious colitis
* Prior colectomy
* Inadequate response or loss of response to previous treatment of UC with tofacitinib, upadacitinib, or other systemic janus kinase (JAK) inhibitor
Incidence of Type 2 Diabetes in the di@Bet.es Study

Our aim was to determine the incidence of type 2 diabetes mellitus in a nation-wide population based cohort from Spain (di@bet.es study). The target was the Spanish population. The sample consisted of 5072 people older than 18 years, in 100 clusters (health centres randomly selected from all over Spain). The following variables were recorded: Socio-demographic and clinical data, survey on habits (physical activity and frequency of selected food consumption) and a physical examination was made (weight, height, waist, hip, blood pressure). A fasting blood draw and an oral glucose tolerance test were performed. Determinations of serum glucose were made. In the follow-up the same variables were collected and HbA1c was determined. A total of 2408 subjects participated in the follow-up (7.5±0.6 years, 39.7% men). In total, 154 people developed diabetes (6.4% cumulative incidence in the 7.5 years of follow-up). The incidence of total diabetes adjusted for the structure of age and sex of the Spanish population was 11.6 cases/1000 person-years (IC95%=11.1-12.1). The incidence of known diabetes was 3.7 cases/1000 person-years (IC95%=2.8-4.6) and the incidence of unknown diabetes was 7.9 cases/1000 person-years (IC95%=5.3-8.1). The main risk factors for developing diabetes were the presence of prediabetes in cross-sectional study, age, male sex, obesity, central obesity, increase in weight, and family history of diabetes. This work provides data about population-based incidence rates of diabetes and associated risk factors in a nation-wide cohort of Spanish population.


Eligibility Criteria:
Inclusion Criteria:

* General Population

Exclusion Criteria:

* diabetes in cross-sectional study
* serious illness that prevents participation
* pregnancy
* surgery within the previous month
* any other disabling situation that prevents participation
Development of the Medicines Optimisation Assessment Tool

The purpose of this study is to develop a prediction-tool, the Medicines Optimisation Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of preventable medication related problems (MRPs). This has the potential to permit pharmacists to identify and focus on the small number of patients (approximately 6%) who are likely to experience a significant MRP while in hospital.

The purpose of this study is to develop a prediction-tool, the Medicines Optimisation Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of preventable medication related problems (MRPs).

The MOAT will be developed following recommendations of the PROGnosis RESearch Strategy (PROGRESS) partnership. A prospective cohort study of 1,500 patients will be used to develop the MOAT from the medical wards of two UK hospitals. Data will be collected on prognostic factors (selected based on a review of published literature and expert opinion) for each patient, together with details of MRPs that occur. All MRPs will be reviewed by an expert panel who will grade for severity and preventability using recognised criteria. Multivariable logistic regression models will be used to determine the relationship between potential risk factors such as polypharmacy, renal impairment, and the use of 'high risk' medicines, and the study outcome of preventable medication related problems that are at least moderate in severity. Bootstrapping will be used to adjust the MOAT for optimism, and predictive performance will be assessed using calibration and discrimination. A simplified scoring system will also be developed, which will be assessed for sensitivity and specificity.

The intention of this research is to develop a prediction-tool (the MOAT), which has the potential to be adopted widely into clinical practice. If the initial research is successful in producing a prediction-tool with good predictive performance further research will be carried out to assess how feasible it would be to use the MOAT in practice, the potential efficiency savings, and an assessment of clinical risk to patients through use of the MOAT.

Eligibility Criteria:
Inclusion Criteria:

* subject admitted to the Medical Division (General, Emergency, and Elderly Medicine) at the study sites

Exclusion Criteria:

* subject admitted for investigation-only
* subject not prescribed medication
* subject both admitted and subsequently discharged outside of core pharmacy working hours
Study of Oxaliplatin, Capecitabine, and Bevacizumab to Treat Older Patients With Colorectal Cancer

Currently there is no one standard of care for older patients with metastatic colorectal cancer. The study will examine the tumor response to capecitabine, oxaliplatin, plus bevacizumab. The study will also gather information on the usefulness and side effects of this treatment combination.

Colorectal cancer is primarily a disease of the elderly, with the median age in the United States of 70 years. Age greater than 65 years at presentation is not a contraindication to standard therapies; acceptable morbidity and mortality, as well as long term survival, are achieved in this patient population. However, studies evaluating combination therapy have generally involved younger patients with high performance status scores. Given the non-over-lapping safety profiles of the proposed study agents and the potential synergy, it would be of benefit to explore the combination of oxaliplatin, capecitabine, and bevacizumab in the treatment of older patients with colorectal cancer. Time to progression, overall response, duration of response, and toxicity profile will be evaluated. The feasibility of using a self-report geriatric assessment tool will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years and above;
* Histologically or cytologically documented adenocarcinoma of the colon or rectum;
* Metastatic disease;
* Measurable disease or assessable but nonmeasurable disease allowed;
* ECOG 0-1
* No prior oxaliplatin or bevacizumab.
* No prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy allowed;
* No prior fluoropyrimidine therapy (unless give in an adjuvant setting and completed at least 4 months earlier);
* No bleeding diathesis or coagulopathy
* Adequate renal and hepatic functions as per protocol;
* Signed informed consent

Exclusion Criteria:

* Clinically significant cardiovascular or peripheral vascular disease;
* Concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, warfarin, or therapeutic heparin;
* Serious non-healing wound, ulcer, or bone fracture;
Effect of Transversus Abdominis Plane Block on Diaphragm Thickness

Hypothesis: Postoperative pain, by preventing effective diaphragmatic contraction, hinders deep inspiration and expiration. Inspiratory and expiratory levels can be assessed by measuring diaphragm thickness using ultrasound.Diaphragm thickness\[DT\] measured at the end of inspiration and expiration will differ between patients who undergo Transversus Abdominis Plane Block\[TAP\] block using the 4-point technique and those who do not. It is anticipated that in patients who receive the block, diaphragm thickness will be greater, serving as an indicator of

Postoperative pain is among the main reasons for the decrease in respiratory function after upper abdominal surgery. Numerous studies have investigated the relationship between pain and respiratory function in abdominal surgeries. While the classic TAP block is used to relieve lower abdominal pain \[Th10-Th12\] after surgery, it may be insufficient in relieving pain in the upper abdominal wall \[Th6-Th9\]. The 4-point TAPb technique is employed to address the pain in this region. Ultrasound allows for non-invasive assessment of changes in diaphragm thickness along with changes in lung volume, and evaluating diaphragm mass and contraction is highly useful in diagnosing respiratory diseases. Previous studies have explored changes in diaphragm thickness and the relationship between total lung capacity \[TLC\], functional residual capacity \[FRC\], residual volume \[RV\] and diaphragm function. However, changes in diaphragm function due to pain prevention in patients undergoing '4-point' TAPb are not well understood. It is aimed to investigate the impact of the 4-point TAP block on the diaphragm in patients undergoing laparoscopic cholecystectomy under general anesthesia. The primary objective of this study is to use ultrasound to examine the effect of the four-point TAP block, administered for analgesia after laparoscopic cholecystectomy, on diaphragm thickness. The secondary objective is to assess the impact of the four-point TAP block on pain and the quality of patient recovery.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent;
2. 18-65 years old;
3. ASA Physical Status 1-2;
4. Scheduled for elective kolesistektomi.

Exclusion Criteria:

1. ≤18, ≥65 years old;
2. Any contraindications nerve blocks;
3. VKİ\>35 kg/m2;
4. Bleeding diathesis;
5. Switching to open surgery;
6. Language barrier;
7. Having undergone upper abdominal surgery previously;
8. Severe kind of chronic lung ilness;
9. Contraindication or allergy to planned drugs.
Exploratory Efficacy of N-Acetylcysteine in Patients With History of COVID-19

A randomized, double-blind, parallel-arm, phase II, explorative study investigating the efficacy and safety of orally administered N-Acetylcysteine (NAC) versus placebo in patients with history of SARS-Cov-2 infection and residual respiratory impairment.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤90 years.
2. History of hospitalization for COVID-19 pneumonia, as documented by positive RT/PCR testing for SARS-Cov-2 infection (nasopharyngeal swab) and suggestive radiological findings at the chest CT scan.
3. Resolution of SARS-CoV-2 infection as defined by negative RT/PCR testing (nasopharyngeal swab).
4. Evidence of residual interstitial lung abnormalities (including any of the following: ground glass, reticulation, or consolidation with overall extent ≥5% of total lung volume) on chest high resolution CT scan (performed during screening or within 30 days from screening visit) AND

One or more of the following:

* DLco ≤ 70 % of predicted value at screening
* Oxygen desaturation at 6-minute walk test (6MWT) ≥4% from baseline value at screening.
* Total Lung Capacity ≤ 80 % of predicted value at spirometry performed at screening
* Exertional dyspnea at screening, as defined by MMRC ≥1

Exclusion Criteria:

1. Evidence of resting respiratory failure, as defined by PaO2 ≤60 mmHg (FiO2 21%) at blood gas analysis at screening.
2. History of interstitial lung disease, or evidence of interstitial lung disease at screening that suggests any of the following: idiopathic interstitial pneumonias; lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis, infectious diseases (Other than SARS-Cov-2 infection) and connective tissue diseases.
3. History of other types of respiratory diseases, including disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude the subject's participation in the study.
4. Any other known disease, medical conditions or blood test abnormalities that in the opinion of the Investigator may put the patient at risk because of participation, interfere with study procedures or cause concern regarding the patient inability to participate in the study.
5. Concomitant treatment with oral corticosteroids and/or other immunosuppressive drugs.
6. Pregnancy status.
7. Incapacity of providing valid informed consent.
The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants

There are studies investigating the dimensional changes following free gingival graft (FGG) around teeth with inadequate attached gingiva, however no study investigating the effect of smoking on dimensional changes following FGG around dental implants exists. In the present study, we hypothesized that smoking might increase the dimensional change of FGG around dental implants and affect the healing of donor site.


Eligibility Criteria:
Inclusion Criteria:

Implants with inadequate attached gingiva on the buccal site, which placed in posterior region at least 1 year ago, and loaded with a fixed prosthetic restoration at least 6 months ago.

Exclusion Criteria:

Implants with peri-implantitis, patients who had previously the soft or hard tissue graft surgery at the site in question, patients who had previously operated from the donor site, patients with systemic disease that may interfere with periodontal surgery, patients taking any medication that can prolong bleeding, patients with immune system disease, infectious diseases such as hepatitis or HIV, individuals under the age of 18, and women with pregnant or breastfeeding.
Conjugated Linoleic Acid in Obese Women

In this trial, the investigators analyzed the effects of eight weeks of CLA supplementation associated with aerobic exercise on body fat and lipid profile in obese women.

The aim of this investigation was to analyze the effects of eight weeks of CLA supplementation associated with aerobic exercise on body fat and lipid profile in obese women. The investigators performed a randomized, double-blinded and placebo-controlled trial with 28 obese women who received 3.2 g/d of CLA or 4 g/d of olive oil (placebo group) while performing an 8-week protocol of aerobic exercise. Dietary intake (food record), body fat (DXA) and biochemical analysis (blood sample) were assessed before and after the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Had no signs or symptoms of disease
* No orthopedic injuries
* Must be inactive or moderately active (defined as performing any type of physical exercise less than twice a week)
* Must be non-smokers
* Must be free from the use of ergogenic aids
* Had no metabolic disorders or chronic degenerative diseases
* Not use drug therapy for body mass loss.

Exclusion Criteria:

* Had frequency to training sessions below 85% of the total sessions