cyrilzakka/clinical-trials huggingface dataset:
Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania

Add-Vacc is an unblinded cluster-randomised trial (CRT) with two arms: (i) the national HPV vaccination programme (girls aged \~14 years, control arm) and (ii) the national programme plus single-dose male HPV vaccination given to a multi-year cohort of boys (intervention arm). The CRT will be conducted in 26 communities/clusters (13 per arm) in northern Tanzania. Boys aged 14 to 18 years in the intervention arm will receive one dose of the 4-valent HPV vaccine (Gardasil®) that protects against HPV 6, 11, 16, and 18. Population genital HPV prevalence in 18 to 21-year-olds will be compared between intervention clusters (female and male vaccination) and control clusters (female vaccination only) at 3 years after the intervention. Blood sampling for immune responses and adverse event data collection will be performed in a subset of 200 male subjects in selected intervention clusters.


Eligibility Criteria:
Inclusion Criteria:

* Parents and adult male participants (aged 18 years) must sign an ICF and male participants aged less than 18 years must sign an informed assent form (IAF), indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and to receive HPV vaccination. If the parent or participant cannot read or write, the procedures must be explained and informed consent/assent must be witnessed by a literate third party who is not involved in the conduct of the study.
* Participants must have been born male, and must be aged 14 to 18 years inclusive at time of vaccination.
* Participants must be living in an intervention community (cluster).
* Participants must be willing and able to comply with the protocol requirements.
* Participants must agree to avoid all non-trial immunisations in the 14 days following vaccination with the trial vaccine, other than emergency vaccinations such as post-exposure rabies or tetanus vaccinations.
* Participants must be healthy as determined by a medical history. A physical examination will be conducted if necessary according to the clinician's judgement.

Exclusion Criteria:

Boys will be excluded from HPV vaccination if:

* They have previously been vaccinated against HPV.
* They have a history of allergy or anaphylaxis to one or more of the HPV vaccine components, to yeast or to latex.
* They are enrolled in another vaccine research study that specifically specifies that they must not participate in a study of another vaccine
* They have been diagnosed with a chronic condition (except HIV, as per the comment above), such as an autoimmune condition, sickle cell disease, degenerative disease, neurologic or genetic disease, among others;
* There are significant conditions or clinically significant findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., it would compromise their safety or well-being).
Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria

The purpose of this study is to Understand the prevalence of non-tuberculous mycobacterial(NTM) infections in the middle-aged and old women patients with bronchiectasis in Mainland China, and explore the characteristics of patients with bronchiectasis comorbid NTM.

The development of bronchiectasis is closely related to chronic infection of pathogenic microorganisms .Bronchiectasis and nontuberculous mycobacterial (NTM) infections are inextricably linked Pathophysiologically. But the incidence rate and characteristics of NTM infections among patients with bronchiectasis remains unclear in mainland China.

In this study, we will collect data of participants about demographic ,co-morbidities ,spirometry, mMRC score ,exacerbation history, QOL-B questionnaire, aetiology, spirometry , HRCT(or CT) scan ,results of microbiology samples and treatments, collect three consecutive sputum(or induced sputum) samples to smear, bacteria culture, acid-fast stain, mycobacterium cultivation and identification, drug susceptibility testing of nontuberculous mycobacteria.To estimate the prevalance of non-tuberculous mycobacterial(NTM) infections in Middle-aged and old women patients with bronchiectasis in northern China. To analyze clinical manifestations and microbiological characteristics of patients with bronchiectasis comorbid NTM infections By 16SRNA and gene sequencing.

In addition, A cross-sectional investigation about lung function and clinical data will be done among patients who have confirmed bronchiectasis with NTM from February 2017 to December 2020.

Eligibility Criteria:
Inclusion Criteria:

1. Middle-aged and old women who are \> or = 50 years of age
2. Patients meet the criteria of bronchiectasis

Exclusion Criteria:

1. Cystic fibrosis
2. After organ transplantation
3. Activity tumor (malignant solid tumor and blood system tumor)
4. Pulmonary interstitial fibrosis with bronchus dilation
5. Allergic bronchopulmonary aspergillosis
6. Diffuse panbronchiolitis
7. Patients refused to sign the informed consent
8. Patients unable to return sputum specimens
A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses

This prospective clinical study will evaluate the intra-operative performance of the powered circular stapler used in left colectomy procedures in a post-market setting.

Surgical staplers have been utilized in colorectal procedures since the early 20th century, with intraluminal staplers used to create the anastomosis since 1979. Successful utilization of these devices, whether in open or laparoscopic procedures, requires extensive training and experience. Even with experience, device issues such as stapler misfire, incomplete firing, low surgeon satisfaction, etc., may occur. In a retrospective study of 349 colorectal resections, 67 (19%) procedures had some type of technical error. The most frequently reported issues from the analysis were positive leak tests, difficulty placing or removing the stapler, and inadequate donuts. Surgeons may also experience psychological or physical stress during procedures due to complications, workload, or other factors.

Patients scheduled to undergo a left-sided colon resection, and who meet study entry criteria, may be enrolled. Investigators will perform each procedure using the powered circular stapler according to the instructions for use (IFU). There will be no blinding or planned-interim analysis. Procedures may be performed open or via minimally invasive surgery (MIS) according to institutional standard-of-care (SOC). Use of a hand port and robotic assistance are permissible providing the powered circular stapler is used to create the anastomosis. Conversion from laparoscopic to open surgery is permissible under the protocol at the surgeon's discretion for the patient's safety.

The final scheduled study visit will occur 28 days post-procedure (routinely scheduled follow-up with surgeon). Follow-up by phone is permissible when an on-site visit is not planned or is more than six weeks post-operative.

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled for colectomy with left-sided anastomosis peformed with a circular stapler;
2. Willing to give consent and comply with all study-related evaluations; and
3. At least 18 years of age.

Exclusion Criteria:

1. Enrollment in a concurrent clinical study;
2. Pregnancy;
3. Physical or psychological condition which would impair study participation;
4. Emergency surgery;
5. ASA Class ≥ IV;
6. The subject is judged unsuitable for study participation by the Investigator; or
7. Unable or unwilling to provide follow-up information 8, Undergoing multiple intraoperative synchronous colon resections;

9. Anastomosis not distal from splenic flexure of the colon 10. Anastomosis of the colon not attempted 11. Subjects with any intraoperative findings identified by the surgeon that would preclude attempting an anastomosis with a circular stapler.
Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone

This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled with metformin alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had diagnosed with type 2 DM before 3 months
* Men and women between the age of ≥ 19 and ≤ 75 years
* FPG ≤ 270 mg/dL at screening visit
* Patients who consent to participate in this trial by written Informed Consent Form

Exclusion Criteria:

* Type 1 DM or secondary diabetes
* Subjects who are administrating oral anti-hyperglycemic drugs or have to take a medicine
* Body mass index \< 20 kg/m2 or \> 40.0kg/m2
* Subjects who are assessed to be inappropriate for this trial by investigator
A Pilot Study to Assess Theragnostically Planned Liver Radiation to Optimize Radiation Therapy

The purpose of this study is to compare radiation treatment plans that are designed for patients with liver cancer. One treatment plan will be created using routine procedures and scans normally performed for radiation treatment planning. The other treatment plan will be created using routine procedures with the addition of two imaging scans; a HIDA (Hepatobiliary Iminodiacetic Acid) scan and an MRI (Magnetic Resonance Imaging) scan. This study will evaluate if adding these imaging scans to treatment planning can reduce the amount of radiation to healthy liver tissue during treatment.


Eligibility Criteria:
Inclusion Criteria

* Subjects must be ≥ 18 years of age at the time of signing informed consent
* Diagnosis of primary liver malignancy (including hepatocellular carcinoma \[HCC\] or cholangiocarcinoma) or liver metastasis from any primary solid tumor site by characteristic imaging findings on CT or MRI, clinical presentation, and/or pathologic confirmation of diagnosis.
* Subjects with other current or prior malignancies are eligible for this study.
* Patients with liver metastases must have at least one of the following clinical factors that may affect liver function:

  1. History of liver resection (at any time)
  2. History of cirrhosis (any cause), fatty liver disease, or hepatic insufficiency due to any cause
  3. Prior radiation to the upper abdomen including radioembolization
* ECOG (Zubrod) Performance Status 0-2.
* Subjects must have a Child-Turcotte-Pugh (CTP) score ≤ 7 to be eligible.
* Patients who have been previously treated with non-SBRT liver directed therapies may be enrolled on study. At least 3 months must have elapsed between the most recent liver-directed therapy and study entry.
* Ability to provide written informed consent and HIPAA authorization
* Subjects with an allergy to contrast agents may be enrolled at the treating physician's discretion with appropriate pre-treatment and symptom management.

Exclusion Criteria

* Subjects who are pregnant or planning to become pregnant during the study. Women of child bearing potential must have a negative pregnancy test
* Subjects must not have received chemotherapy within 2 weeks of planned 1st day of RT.
* No more than 3 lesions may be treated. The maximum sum of the diameter(s) of the lesion(s) must be ≤6 cm
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (or infections requiring systemic antibiotic treatment), active upper GI ulceration or hemorrhage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would in the opinion of the investigator limit compliance with study requirements
The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain

This study aims to verify if patients with nerve-related leg pain benefits from neurodynamic treatment over two weeks.

Nerve-related leg pain (NRLP) although less prevalent than low back pain itself, is associated with higher economic and social burden, and has been considered a predictor of chronicity and disability among subjects with low back pain.

Numerous approaches are proposed for its management; however, evidence regarding the best therapeutic approach is lacking. Neurodynamic techniques are proposed to be effective to manage NRLP.

Thus, this study aims to verify, through a randomized controlled trial, the effectiveness of a two-week program of neurodynamic techniques on pain and disability in individuals with NRLP.

Eligibility Criteria:
Inclusion criteria:

* unilateral leg pain (Intensity ≥ 3)
* Pain distal to the buttocks
* Reproduction of symptoms and change in symptoms with structural differentiation (cervical return to neutral position or ankle dorsiflexion) with slump test;

Exclusion criteria:

* cauda equina syndrome;
* bilateral leg pain;
* crossed Lasègue sign;
* previous surgery in the lumbar spine;
* inflammatory arthropathies;
* malignancy
* being in litigation or in work-compensation due to back and/or leg pain
* being receiving physiotherapy treatment at the time of baseline assessment
Effect of Oral Carbohydrate on Serum S-100β Protein and Development of Postoperative Delirium in Elderly Patients

This study is to evaluate the effects of preoperative carbohydrate intake on perioperative neuroinflammation and development of delirium.

Perioperative insulin resistance may primarily contribute to development of postoperative delirium in high risk patients. Preoperative administration of oral carbohydrate reduces insulin resistance. The investigators aimed to investigate the influence of carbohydrate loading on the serum level of S-100β, a surrogate marker of delirium, and the incidence of postoperative delirium in elderly patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total hip replacement or total knee replacement surgery

Exclusion Criteria:

* Diabetes
* Dementia
* Gastro-esophageal reflux
* Upper gastrointestinal motility disorder
* Inflammatory bowel disease
* Intraperitoneal malignancy history
* Inability to perform cognitive function test
LeucoPatch in Malleoli Ulcer Study

An International Multicenter study evaluation, off the effect of the fully autologous growth factor-containing patch LeucoPatch, on healing of recalcitrant malleoli ulcers.

To compare the impact of LeucoPatch as part of usual care in multidisciplinary Foot clinic settings, versus usual care in the same clinics on malleoli ulcers healing.

Diabetic Foot Ulcers are a common and severe complication, that affects Patients Life Quality. Healing time is often long and the Diabetic foot ulcer is the dominating not traumatic reason for leg amputation.

Treatment of a diabetic foot ulcer requires debridement, offloading, regularly foot care, specially tailored shoes, antimicrobial treatment, and sometimes even surgical interventions. Despite all these interventions the diabetic foot ulcer may not heal.

Malleoli ulcers in patients without diabetes share several features of pathogenesis and lack of healing potentials with the Diabetic Ulcer. Like the features of pathogenesis and lack of healing potential and are therefore included in this study.

Research has shown that other methods such as Growth factors may be a way to enhance the chance of healing.

Growth Factors have been shown to have a positive effect in studies, but no products that are characterized as autologous have as yet obtained positive results in controlled studies.

LeucoPatch is produced solely from a patient´s own blood without addition, and is autologous. LeucoPatch appears as an elastic membrane and can be fitted to the individual ulcer.

LeucoPatch is shown to contain as many or more growth factors as existing products, and has a high concentration of fibrin, platelets and leukocytes.

A non-controlled study was made on ulcers less than 10cm 2 and 52% had competed epithelization after 20 weeks. An International randomized multicenter trial is ongoing to evaluate the efficacy and safety of LeucoPatch on healing of hard to heal diabetic foot ulcers below the malleoli.

This Study is designed to test the healing effect of the LeucoPatch on malleoli ulcers, the Patient will be randomized and the healing will be confirmed by a blinded observer.

Eligibility Criteria:
Inclusion Criteria:

* Foot ulcer at the malleoli area between 0,25 cm² and 5,0 cm²
* Foot ulcer duration more than 6 weeks
* No need for arterial revascularisation- as judged by the Investigator
* informed consent

Exclusion Criteria:

* Hemoglobin concentration under 6.5 mmol/l screening
* Non-compliant with blood-letting
* Clinically infected ulcer
* Patient planned for or has had a revascularization procedure in the affected leg within the last 8 weeks
* The ulcer have been treated with growth factors in the last 8 weeks
* History of deep venous insufficiency, chronic venous leg ulcer or stasis dermatitis
* Breast-feeding women or fertile women not agreeing to use an effective method of contraception
* Participation in another clinical ulcer-healing study within the last 4 weeks
* Patient has previously been randomized in this study
* Judgement by the investigator that the patient is not able to participate in the study
Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥ 18 kg/m\^2
* HCV RNA ≥ 10000 IU/mL at screening
* Prior treatment failure to a regimen including interferon with or without RBV
* HCV genotype 1 or 3
* Chronic HCV infection
* Cirrhosis determination
* Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Current or prior history of clinically significant illness other than HCV
* Screening ECG with clinically significant abnormalities
* Prior exposure to HCV specific direct acting antiviral agent
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of non-HCV etiology
* Hepatitis B
* Active drug abuse
* Use of any prohibited concomitant medications
Umbilical Cord Derived Mesenchymal Stromal Cells For The Treatment of Severe Steroid-resistant Graft Versus Host Disease

MESENCHYMAL STROMAL CELLS (MSC) have shown promising albeit not always consistent therapeutic effects in the treatment of severe steroid-resistant acute Graf versus Host Disease. Remarkably, in all reported clinical studies the toxicity of Mesenchymal stromal cells administration has been found consistently negligible. The investigators believe that Umbilical Cord (UC) derived Mesenchymal stromal cells may represent a stronger immunosuppressive tool for such clinical emergency and no data suggest any change in the safety profile of these cells. For this reason, and in the best interest of the patient, the investigators plan to test the safety and activity of Umbilical Cord Mesenchymal stromal cells when given sequentially to another partially effective treatment of steroid resistant acute graf versus host disease such as Pentostatin.


Eligibility Criteria:
Inclusion Criteria:

Patients are required to meet the following inclusion criteria:

1. Patients with steroid refractory grade III-IV classic acute graft versus host disease (GvHD)occurring within 100 days after transplant or induced by donor lymphocyte infusions (DLI) or T-cell add back. Steroid refractory graft versus host disease (GvHD)is defined according to Pidala and Anasetti10 as follows: a) progression of at least 1 overall grade within 3 days of optimal steroid treatment; b) failure to demonstrate any overall grade improvement over 5 to 7 days; c) incomplete response by 14 days of 2 mg/kg/day of steroid therapy.
2. Patients with persistent, recurrent, or late acute graft versus host disease (GvHD) (features of acute graft versus host disease occurring beyond 100 days, often during withdrawal of immune suppression).
3. Patients with an overlap syndrome in which diagnostic or distinctive features of chronic graft versus host disease (GvHD) and acute graft versus host disease (GvHD) appear together79.

Exclusion Criteria:

1. Inability to obtain written informed consent
Comparison of the Healing Properties on Corneal Cells of Groth Factor-enriched Plasma and Autologous Serum From Aniridia Patients

Keratopathy of patients with aniridia leads to epithelial scarring disorders and a progressive clouding of the cornea linked to this abnormal healing (fibrosis). Treatment with autologous serum is usually undertaken to promote epithelial healing.

However, autologous serum does not prevent the formation of fibrosis, whereas growth factor-rich plasma appears to be associated with a reduction in the in vitro expression of fibrosis markers. This study seeks to compare the in vitro healing and anti-fibrotic properties of autologous serum and growth factor rich plasma from aniridia patients and healthy controls.

Blood collection from aniridia patients and healthy controls, half of which will be used to make autologous serum and the other half to make growth factor rich plasma, used for in vitro studies.

A conjunctival impression will also be taken at the inclusion of the patients.

Eligibility Criteria:
Inclusion Criteria:

For patients with aniridia:

* With aniridia
* Patient weighing more than 40 kg
* If the patient is being treated with autologous serum, a delay of 8 weeks after the last blood collection
* If a blood donation has been made, a delay of 8 weeks must be respected after the last donation

For controls:

* Non-aniridia (no clinical signs)
* Weighing more than 40 kg
* Matched to a case for sex and age +/-5 years
* No known diabetes
* If a blood donation has been made, a delay of 8 weeks must be respected after the latter

Exclusion Criteria:

* Person benefiting from a legal protection measure
* Pregnant or breastfeeding woman
Release of Cytokines by Stimulated Peripheral Blood Mononuclear Cells (PBMC) From Chronic Periodontitis Subjects

Background and Objective: It has been reported that peripheral blood mononuclear cells (PBMC) from periodontal patients have a different profile of cytokine release when compared to the ones of healthy patients. Cigarette smoking is a recognized risk factor for periodontitis and is known to affect the systemic and local immune responses. Thus, the aim of the present study was to obtain preliminary data about the interaction of periodontal condition and smoking in the secretion of some cytokines by PBMC.

Material and Methods: PBMC samples were isolated from 19 donors, divided into generalized chronic periodontitis (P; n=10) and periodontal health (H; n=9) groups. In addition, the smokers and non-smokers of each group were separately evaluated: SP- smokers with severe generalized chronic periodontitis (n=5); SH- periodontally healthy smokers (n=5); NSP- non-smokers with severe generalized chronic periodontitis (n=5) and NSH- periodontally healthy non-smokers (n=4). Cells were incubated for 24-48 hours in 500 µL wells containing RPMI 1640 and stimulated with 1.0 ng/mL of E. coli LPS. Supernatants were used to quantify the amounts of TNF-α, IL-6, IL-8 and IL-10 released using ELISA kits.


Eligibility Criteria:
Inclusion Criteria:

* periodontitis

Exclusion Criteria:

* diabetes