cyrilzakka/clinical-trials huggingface dataset:
Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic Hepatitis B Virus (HBV) Infection

This study was designed for changes in endotoxaemia, endotoxin-binding factors, sICAM-1 (soluble intracellular adhesion molecule-1), and cytokines during progression of chronic HBV infection. Patients with chronic HBV infection and healthy control are included. A limulus assay was used to measure plasma endotoxin level and ELISAs were used to measure the concentrations of interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor-α (TNFα), sICAM-1, and soluble CD14 (sCD14).

1. Patients Patients with chronic HBV infection and healthy volunteers were enrolled. There were asymptomatic carriers group, patients with chronic hepatitis, patients with hepatic cirrhosis, and patients with acute on chronic liver failure.
2. Endotoxin assay Blood samples were obtained under aseptic conditions by peripheral venipuncture and using pyrogen-free syringes, needles, and glassware. Plasma samples were heated at 70℃ for 10 min. Plasma concentration was then measured in duplicate using a commercially available Limulus amebocyte lysate assay following the manufacturer's protocol.
3. ELISA ELISA kits were used to assess in duplicate the plasma concentrations of IL-6, IL-10, TNFα, sICAM-1 and sCD14.

Eligibility Criteria:
Inclusion Criteria:

* Chronic HBV infection
* Diagnosis confirm to guideline of Chronic Hepatitis B and acute on chronic liver failure of the Asian Pacific Association for the Study of the Liver (APASL).

Exclusion Criteria:

* All the patients had no obvious mycotic infection, Gram-negative sepsis, or bacterial infection (except from the digestive system)
* Infection of hepatitis A, C, D, or E virus
* Autoimmune liver disease
* Alcoholic liver disease
* Metabolic liver disease
* Drug-induced liver injury
* Parasitic disease of the hepatobiliary system
* Malignancy
* Serious exacerbation of cardiovascular and respiratory system diseases
Pilot Testing of a Behavioral Intervention for Chronic Pain in Individuals With HIV

Due to its specific pathophysiology and impact on health outcomes, the Institute of Medicine has described chronic pain as a complex chronic disease and a "national public health crisis." The unique neurobiological basis and psychosocial context of chronic pain in HIV-infected patients underscores the importance of developing and testing a behavioral intervention specifically tailored to this population. This study will pilot test a newly-developed behavioral intervention for chronic pain tailored to individuals with HIV.

Chronic pain is a chronic condition with a unique neurobiologic basis, which has a substantial impact on physical and emotional function. Chronic pain in HIV-infected patients is common, and associated with serious health consequences, including up to 10 times greater odds of impaired physical function. Many pharmacologic therapies, including opioids, often do not lead to improved pain and function, and carry significant risk. Evidence-based behavioral interventions are among the most effective and safe non-pharmacologic chronic pain treatments investigated in the general medical population. Therefore, behavioral interventions to improve pain, physical, and emotional function in HIV-infected patients are needed. There is much to be learned from existing interventions. However, the success of a behavioral intervention is heavily influenced by how well it is tailored to the target population's biological, psychological, and social environment. Therefore, in this study investigators will conduct a two-arm pilot randomized controlled trial of a recently-developed behavioral intervention compared to routine HIV and pain care, to determine feasibility, acceptability, and preliminary impact.

Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in the Center for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort
2. Age ≥ 18 years
3. Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least moderate pain for at least 3 months)
4. Moderately severe and impairing chronic pain (PEG pain questionnaire = average of all three times is 4 or greater)

Exclusion Criteria:

1. Do not speak or understand English
2. Are planning a new pain treatment like surgery
3. Cannot attend the group sessions.
Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study

Natural orifice specimen extraction surgery (NOSES) has gained widespread recognition among scholars and has gradually been promoted and popularized around the world. However, the development of NOSES is still in the exploratory stage and there is a lack of strong evidence from evidence-based medicine to support its feasibility and safety, which has greatly affected its clinical application and development. Based on this, at the call of Professor Xishan Wang, the Chinese NOSES Alliance conducted a large retrospective clinical study involving multiple centers. By summarizing the NOSES cases of nearly 100 centers in China, the study aims to clarify the current status of NOSES surgery in China. Additionally, a comprehensive analysis and summary was conducted by combining the basic information of NOSES patients, perioperative data, postoperative pathological data, and follow-up information to further demonstrate the safety and feasibility of NOSES in the treatment of colorectal cancer. This study also provides more real and objective evidence-based medicine support for the promotion and development of NOSES surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological diagnosis of primary malignant tumor in the colon or rectum;
2. The surgery meets the definition in the "Consensus of NOSES Experts in Colorectal Cancer";

Exclusion Criteria:

1. Postoperative pathological diagnosis does not belong to primary malignant tumors in the colon or rectum;
2. The surgery does not meet the definition in the "Consensus of NOSES Experts in Colorectal Cancer".
Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects

Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.

Agili-C™ implant is a CE marked, bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects.

The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Up to 3 treatable cartilage lesions, ICRS IIIa - IVb on the femoral condyles or the trochlea,
3. Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
4. KOOS Pain score at baseline is not less than 30 and not more than 65
5. Must be physically and mentally willing and able to comply with post- operative rehabilitation protocol and scheduled clinical and radiographic visits.
6. Informed consent signing

Exclusion Criteria:

1. Bony defect depth deeper than 8mm, according to imaging Articular cartilage lesions in the tibia or the patella, ICRS grades IVa and IVb
2. Any previous ligamentous repair or malalignment correction in the index knee within the last 3 months
3. Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
4. Lack of functional remaining meniscus
5. Meniscal transplantation in the past 6 months
6. Malalignment more than 5 degrees varus OR 5 degrees valgus according to standing X-ray
7. Any known tumor of the index knee
8. Any know history of infection of the index knee
9. Any known history of inflammatory arthropathy or crystal-deposition arthropathy
10. Any known systemic cartilage and/or bone disorder such as but not limited to chondrodysplasia or osteogenesis imperfecta
11. Body mass index \>35
12. Osteoarthritis of the index knee graded as 4 according to the Kellgren- Lawrence scale
13. Chemotherapy treatment in the past 12 months
14. Any previous surgical cartilage treatment in the index knee within the last 6 months
15. History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate
16. Patient who is pregnant or intends to become pregnant during the study
17. History of any significant systemic disease, such as but not limited to, HIV infection, hepatitis infection or HTLV infection; known coagulopathies, that might compromise the subject's welfare
18. Known substance abuse or alcohol abuse
19. Participation in other clinical trials within 30 days prior to the study or concurrent with the study
20. Known insulin dependent diabetes mellitus
21. Unable to undergo MRI or X-ray
The Effect of Anemia in Infancy on the Microbiome and Systemic Metabolism

Serum and fecal samples were collected from infants at either 6-7 m of age or 12-13 m of age. Serum and feces were analyzed locally for hemoglobin status or evidence of parasites, and standard of care was provided. Excess serum was transported to UC Davis for metabolomics analysis and the University of Hohenheim for iron status assessment and measurement of inflammatory markers. Fecal samples were transported to UC Davis for measurement of the microbiome structure and function.

Sample collection occurred between August and November 2014. A total of 203 infants and their parents (101 at 6-7 m of age and 102 at 12-13 m of age) receiving care at the Moronacocha Health Center in Iquitos, Peru were recruited. All subjects were residents of Moronochocha, Iquitos, Loreto, outwardly healthy, and born at term with a birth weight of at least 2,500 g. Venous blood samples were collected by a lab technician at the local health center. Hemoglobin concentrations were immediately measured, and treatment given if warranted. Samples were subsequently transported to Selva Amazonica clinic, centrifuged, and serum was stored at -80 °C. Stool samples were collected by caregivers from diapers at home, taken to Selva Amazonica Clinic, and aliquoted. Fecal samples were analyzed for parasites at Selva Amazonica, and any necessary treatment was provided at the local health center. Serum and stool samples were shipped to UC Davis on dry ice, where they were stored at -80 °C until metabolomics and microbiome analyses. Serum aliquots were also shipped to the University of Hohenheim, Stuttgart, Germany for iron assessment, and measurement of inflammatory markers. All data integration and interpretation was performed at UC Davis.

Eligibility Criteria:
Inclusion Criteria:

* Outwardly healthy,
* birthweight \> 2,500 g
* term births
* residents in Moronacocha, Iquitos, Loreto

Exclusion Criteria:

* Obvious signs of illness or malnutrition
* birthweight \< 2,500 g
* preterm birth
* not a resident of Moronacocha, Iquitos, Loreto
Effect of Bromfenac on Pain Related to Pterygium Surgery

To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution (bromfenac) 0.1% dosed twice daily for the treatment of ocular inflammation and pain after pterygium excision with amniotic membrane transplantation(AMT).

Patients scheduled to undergo pterygium excision with AMT were randomized to receive added topical bromfenac or artificial lacrima at 3 days before and 7 days after the surgery. Pain intensity was evaluated with the visual analog scale(VAS) and present pain index(PPI) with the short form of the McGill Pain Questionnaire. psychological state used Self-rating of Depression Scale(SDS) and Self-rating of Anxiety Scale (SAS) to assess. Ocular inflammation was assessed with an automated bulbar redness grading technique. The irritative symptoms evaluation was carried out by an independent investigator at each visit with questionnaires of ocular symptom scores(OSS). Corneal epithelial healing rate was calculated after following up. All patients had follow-ups at the day 1, day 3, day7 and day 10.

Eligibility Criteria:
Inclusion criteria

1. Patients with unilateral or double pterygium
2. The gender is not limited, age 45-75 years old
3. intraocular pressure \<21mmHg
4. follow the preoperative and postoperative drug regimen and ensure regular follow-up

Exclusion Criteria

1. Patient factors: lack of cooperation and poor compliance.
2. Severe dry eye, Sjogren's syndrome, cicatricial pemphigoid, and other systemic diseases that seriously affect the structure or function of the ocular surface.
3. Glaucoma or high intraocular pressure (above 21 mmHg), active uveitis, retinal detachment and other diseases.
4. History of systemic diseases, such as uncontrolled diabetes and hypertension, rosacea, severely impaired cardiopulmonary function or other diseases that cannot tolerate surgery; central nervous system disorders affect patient perception, trigeminal neuritis, trigeminal neuralgia, and tongue Pharyngeal neuralgia, migraine and period of toothache attack.
5. history of drug allergies, such as NSAID drugs, tobramycin, anesthetics and so on. Smokers and alcoholics (smoking volume \>15 cigarettes/day, pure alcohol consumption\>100 ml/week).
6. Other history of eye surgery, such as history of eye trauma, history of glaucoma surgery, history of cataract surgery, history of retinal surgery, or other serious injuries to the eyelids, conjunctiva, cornea, and other tissues of the eye surface.
Comparison of Miller's Blade and Airtraq Laryngoscope in Children

The Airtraq optical laryngoscope has recently been available in pediatric sizes. The investigators compared the efficacy of Airtraq with the Miller laryngoscope as intubation devices in paediatric patients. This prospective, randomized study was conducted in a tertiary care teaching hospital. Sixty American Society of Anesthesiologists (ASA) grade I-II paediatric patients of 2-10 years, posted for routine surgery requiring tracheal intubation were randomly allocated to undergo intubation using a Miller (n = 30) or Airtraq (n = 30) laryngoscope. The primary outcome measures were time of intubation, ease of intubation, number of attempts and POGO score. We also measured hemodynamic changes and airway trauma.

After approval from the institutional Ethical Committee, 60 patients were studied. A randomised prospective study was planned to compare size 1 Airtraq (Prodol Meditec S.A., Vizcaya, Spain) with Miller blade of same size.

The children included in the study were 2-10 years of age, American Society of Anesthesiologists (ASA) physical status I-II and posted for elective surgeries requiring tracheal intubation. The following were excluded from the study: (i) patients with upper respiratory tract symptoms, (ii) those at risk of gastroesophageal regurgitation and (iii) those with airway-related conditions such a trismus, limited mouth opening, trauma or mass. Sixty patients were equally randomized to one of the two groups (Airtraq and Miller) of 30 each for airway management using a computer-generated randomization program.

Written informed consent was taken from the parents prior to intervention and a standardized protocol for anesthesia was maintained for all cases. All the children were kept nil per mouth as per standard guidelines. Intubation attempts were taken using Airtraq or Miller on a random basis.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists physical status I-II,
2. elective surgeries requiring tracheal intubation

Exclusion Criteria:

1. patients with upper respiratory tract symptoms,
2. those at risk of gastroesophageal regurgitation and
3. those with airway-related conditions such a trismus, limited mouth opening, trauma or mass.
Osteocalcin Level in Gingival Clavicular Fluid During Canine Retraction in Periodontal Compromised Patients

Osteocalcin levels can be measured Gingival crevicular fluid (GCF). Changes in osteocalcin levels can provide important information about the status of bone metabolism and bone remodeling. The levels of this markers in GCF can provide information about the status of bone remodeling in the surrounding bone tissue in periodontal affected teeth.

Osteocalcin levels can be measured using a blood test or by analyzing the levels of osteocalcin in urine or saliva. Changes in osteocalcin levels can provide important information about the status of bone metabolism and bone remodeling. Osteocalcin has been found to be present in Gingival crevicular fluid (GCF), along with other bone metabolism markers such as alkaline phosphatase and tartrate-resistant acid phosphatase. The levels of these markers in GCF can provide information about the status of bone remodeling in the surrounding bone tissue. Orthodontic tooth movement is influenced by the remodelling ability of surrounding bone and soft tissue, such as PDL and gingiva. Bone remodelling occurs in coordination, requiring coupling of bone formation after resorption. Orthodontic force induces an aseptic inflammatory response, involving cytokines and chemokines. . Increased levels of osteocalcin in body fluids indicate abnormal bone turnover activity.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patients who were seeking for orthodontic treatment with controlled previous chronic periodontitis.
* Pocket depth of more than 5 mm before receiving non-surgical periodontal treatment or/and Pocket depth of less than 4 mm after periodontal therapy.
* Sever to very sever irregularity of mandibular anterior arch according to Little's irregularity index ranging from 7 to 10 mm with acceptable oral hygiene.
* all the permanent dentition excluding third molars should be present.
* No systemic disease or history of prolonged use of medication interfering with tooth movement as corticosteroids.

Exclusion Criteria:

* Previous orthodontic treatment.
* Patients with aggressive periodontitis or Any smoking habits.
* Pregnant or lactating female patients were excluded.
Evaluation of Group CBT Programme With Breast Cancer Patients

The purpose of this study is to examine whether a group CBT intervention is effective in reducing psychological distress in women with primary breast cancer.

The diagnosis and treatment of cancer is associated with high levels of psychological distress, which can be long-term in duration. The end of adjuvant therapy can be a time which patients find anxiety provoking; as concerns of recurrence and how to return to life after treatment often arise at this juncture.

Cognitive behaviour therapy has demonstrated efficacy in reducing anxiety and depression in people with cancer on a 1:1 basis. The CBT model has been shown to be significantly more beneficial than supportive counselling. Therapy delivered in groups is considered desirable because of its cost effectiveness, and its potential to confer additional benefits in terms of peer support, reduced isolation and modelling of adaptive strategies by other group members.

No studies have looked at the changes in participants health beliefs and beliefs about their ability to copy (self-efficacy) with stress and tolerance of uncertainty following group CBT and the relationship with psychological distress.

The aim of this study is to evaluate a GCBT programme intervention against a waiting list control and to examine its effects on health beliefs, self-efficacy, coping, tolerance of uncertainty and psychological distress in women with early diagnosed breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Primary breast cancer
* post adjuvant treatment

Exclusion Criteria:

* Women with metastatic disease
* Severe cognitive impairment (will not be able to obtain consent or participant in group intervention)
* Inability to complete a questionnaire
A Study of Diffusing Alpha Radiation Therapy for Target Treatments of Malignant Tumors

This study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.

This is an Open label, one arm, prospective study for Compassionate use for the treatment of malignant tumors. The study objectives are to collect data on the safety and efficacy of DaRT among patients who do not fit the entry of existing investigational trials.

The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with any malignancy
* Subjects with a tumor size ≤ 7 centimeters in the longest diameter
* Subjects over 18 years old
* Subjects' life expectancy is more than 6 months
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after treatment.
* Subjects/Surrogate decision maker are willing to sign an informed consent form

Exclusion Criteria:

* Known hypersensitivity to any of the components of the treatment.
* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
* Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.
* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
* High probability of protocol non-compliance (in opinion of investigator).
* Subjects/Surrogate decision maker not willing to sign an informed consent.
* Women who are pregnant or breastfeeding.
Gaze Contingent Feedback in Major Depressive Disorder (MDD)

The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of Major Depressive Disorder (MDD)

The study examines giving depressive participants gaze-contingent feedback as a novel attention training procedure. Half of the participants will receive contingent feedback while the other half would receive non-contingent "placebo" feedback.

Eligibility Criteria:
Inclusion Criteria:

* A signed consent form
* Men and women between the ages of 18 and 65.
* Meeting a current diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV
* MDD as the primary diagnosis: In cases of co-morbidity, MDD will be deemed as the most distressing and clinically significant condition among the co-morbid disorders
* Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.

Exclusion Criteria:

* Psychotic episode in the past or the present time.
* Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
* Another psychotherapeutic treatment during the study.
* Usage of neuroleptic medication.
* Change in medication status during the study.
* Substantial usage of drugs or alcohol in the present time.
* Poor judgment capacity (i.e., children under 18 and special populations).
* High Risk of Suicide.