cyrilzakka/clinical-trials huggingface dataset:
Exercise Therapy in Patients With Axial Spondyloarthritis

Regular exercise, such as brisk walking, has been shown to lower levels of indicators of inflammation in the blood in people with long term conditions. This includes people with heart disease, kidney disease and diabetes. Axial Spondyloarthritis (axSpA) is an inflammatory condition with prescribed medication focusing on reducing inflammation. However, the effect of exercise on indicators of inflammation in axSpA is unknown.

The research study intends to investigate whether a 12-week period of regular exercise can have favourable effects on inflammatory markers in the blood.

Over 200,000 people in the UK have axial spondyloarthritis (axSpA). In 80% of cases the condition begins between 20-30 years of age. Exercise is encouraged as an essential treatment of axSpA, with the potential to promote well-being, flexibility, posture and pain management. Axial spondyloarthritis is an inflammatory arthritis and raised levels of indicators can be detected in the blood (e.g C-reactive protein). These markers are released as a consequence of the condition, but some, such as TNF-alpha, also promote further disease development.

In other patient groups with inflammatory diseases it has been demonstrated that regular exercise (brisk walking) can lower the levels of pro-inflammatory blood markers and increase levels of anti-inflammatory markers, independent of weight loss. Despite axSpA being an inflammatory condition with prescribed medication focused on reducing inflammation, there are no studies which have assessed the potential of exercise as an anti-inflammatory treatment in axSpA.

This research study will investigate the effect of 12 weeks of a home-based walking exercise intervention on measures of systemic inflammation and body composition. Measures of well-being and disease activity will also be investigated using established and validated methods. There will be an exercise and control group, both containing 10 participants. In the control group, patients will carry on with their normal activity. This proof-of-concept study will determine the potential of exercise as an additional anti-inflammatory treatment for patients with axSpA.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Axial Spondyloarthritis by a consultant rheumatologist.
* Without other significant cardiovascular comorbidities.
* Receiving stable dose NSAID treatment.
* Able to commit to the time demands of the study.

Exclusion Criteria:

* Unable to undertake exercise due to physical or psychological barriers.
* Presence of hip or peripheral joint disease.
* Contraindication to exercise training (American College of Sports Medicine guidelines).
* Excessively active (score of high on International Physical Activity Questionnaire).
* Unable to communicate sufficiently in English.
* Female participants who are pregnant, lactating, or planning pregnancy during the course of the study.
* Inability to give informed consent or comply with the testing and training protocol for any reason.
* Presence of chronic anaemia.
* Co-morbidity that the research team determine to be a contraindication to involvement.
Cannabinoid Modulation of Pain

The purpose of this study is to test the effects of cannabinoids on pain response using a variety of human experimental pain models.


Eligibility Criteria:
Inclusion Criteria:

* At least one lifetime exposure to cannabis
* Acceptable Birth Control methods for females

Exclusion Criteria:

* Cannabis naive
* Medical or psychiatric contraindications
* Analgesic medication
* Previous sensitivity to THC or cannabis
Adding Insulin to IVF Culture Media Significantly Improve Outcome

Add insulin to a single step culture media for IVF embryo culture from day 0 to day 5/6 of In Vitro culture and detect the the effect upon embryo quality and implantation potential.

The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding insulin as a hormon and growth factor might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to arm of the same culture media and yhe same culture condition but with one arm with insulin and the other is traditional one and closely monitor the outcome within the 2 arms abd record the results

Eligibility Criteria:
Inclusion Criteria:

* normal responder
* PCOS
* Tubal factor infertility
* mild asthenozoospermia

Exclusion Criteria:

* patient over 40
Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Normal group: We will collect normative data from healthy individuals to include baseline data, screening, and images. Up to 500 people will be enrolled and can include normal healthy volunteers, staff and students/trainees. Data will be collected one time with no follow up.

Patient group: We will prospectively collect data using one instrument (camera) (SnapshotNIR, Kent Imaging, Calgary, Alberta, Canada). We will collect non-contact imaging data before surgeries, during surgeries (if feasible), and during follow-up clinic visits. We will collect vascular data, demographic medical history, wound characteristics and measurements, frequency of debridement, off-loading, and clinic visits from existing medical records. We will collect lab data such as cultures glycosylated hemoglobin, hemoglobin and hematocrit, ESR, CRP and eGFR obtained per standard of care.

Imaging with this device is research-only.

This is a prospective, observational study. All medical and surgical care provided to the patient group will be standard of care.

Patient group: Once a patient is identified as requiring vascular intervention or lower extremity ulceration (includes lower extremity wound of any cause, a surgical incision, a flap or graft) and consent to participation, their lower extremity will be imaged. They will be imaged preop, intraop (if feasible) and on post-op day 1 + or - 7 days if they require surgery and for each surgery related to the ulceration. They will also be imaged once a month in follow up for up to a total of 6 months or healing of the wound, determined by study physician.

Normal group: The normal group will have one-time imaging and data collection.

The Kent instrument does not touch the patient and is being evaluated to measure perfusion to predict wound healing, flap survival and amputation level healing. They are research only and not standard of care, and are not being used to determine care in the patient group.

Eligibility Criteria:
Investigator patients

Inclusion Criteria:

* Patient of the investigators
* Diagnosis of diabetes mellitus
* One or more moderate to severe diabetic foot ulcers/infections
* 18-89 years of age

Exclusion Criteria:

* Non-diabetic
* Is pregnant or plans to become pregnant
* Is nursing or actively lactating
* Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
* Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials
* Patients with a history of poor compliance

Normal Healthy volunteers

Inclusion Criteria:

* Over 18
* Have a foot

Exclusion Criteria:

* Foot wounds
* Non-English speaking
Evaluation of L-PRF as an Antibiotic Slow-release Biological Device in the Treatment of Moderate Periodontitis

This study aimed to evaluate the efficacy of leukocyte platelet-rich fibrin (L-PRF) as a local sustained released device for antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from stage II periodontitis with probing depth and exhibiting bleeding on probing.
* Patients showing good oral hygiene.
* No history of periodontal therapy (surgical and non-surgical) for the past 6 months.

Exclusion Criteria:

* Patients with known systemic and debilitating diseases.
* Patients who had any previous adverse reactions to the products (or similar products) used in this study.
* Patients who have any autoimmune diseases.
* Patients who have any known disease that interfere with periodontal procedure.
* Smokers.
* Pregnancy and lactating women.
* Use of antibiotics during the last 6 months.
Oral Propranolol for Reducing Pediatric Dental Patients Anxiety

Evaluating anxiety, heart rate and behavior during dental extractions after oral dose of either Propranolol, Midazolam or a combination of both in uncooperative pediatric patients.

Use of 0.5 mg/kg of Propranolol or a combination of Propranolol and Midazolam for the first time to manage uncooperative pediatric dental patients anxiety, comparing with Midazolam by evaluating anxiety, heart rate and behavior during administration of local anesthesia and extraction.

Eligibility Criteria:
Inclusion Criteria:

* High to extreme fear of tooth or molar anesthesia and removal (Frankl: Definitely negative).
* Scoring more than 19 points on MCDAS(f).
* Healthy pediatric patients (ASA I) aging 8-10 years.
* Indication for primary tooth or molar extraction.
* Fasting if indicated (severe gag reflex).
* Airway assessment (Mallampati and tonsillar hypertrophy).

Exclusion Criteria:

* Asthma or any other obstructive pulmonary disease.
* Cardiac failure.
* Cardiac arrhythmia.
* Renal failure.
* Diabetes.
* Current use of another ß-adrenoreceptor antagonist.
* Current use of anxiolytic or antidepressant medication.
* Currently in psychotherapy for dental anxiety.
* Systolic blood pressure \<100 mmHg.
* Diastolic blood pressure \<60 mmHg.
* Active Upper respiratory infection.
Effect of Muscle and Skin Fixation of Thoracic Drainage Tube on Postoperative Pain

Lung cancer is the leading cause of cancer-related death worldwide. Thoracoscopic pulmonary resection is a prevalent management for early stage of lung cancer. Placement of chest tube is the standard procedure after surgery, which causes pain that cannot be ignored. The investigators aimed to determine whether a muscle layer fixation of thoracic drainage tube could release postoperative pain in patients with uniport thoracoscopic pulmonary resection compared with conventional skin fixation.


Eligibility Criteria:
Inclusion Criteria:

* 18\<age\<80;
* ASA≤III
* Patients with no clinically significant cardiac history, such as ischaemic heart disease, valvular heart disease, rhythm disturbances such as frequent atrial fibrillation or premature ventricular contractions (PVCs). Patients with significant cardiac history should be optimized according the relevant guidelines before surgery is considered.
* Normal cardiopulmonary function \[predicted forced expiratory volume in the first second(FEV1%) \>50% and ejection fraction (EF) \>50%of predicted value\]. Resting blood gas analysis showing arterial partial pressure of oxygen (PaO2)≥75 mmHg and arterial partial pressure of carbon dioxide (PaCO2) \<45 mmHg;

Exclusion Criteria:

* History of ipsilateral surgery and other conditions which can result in extensive pleural adhesion;
* Coagulopathy, hypoxemia (PaO2 \<60 mmHg), hypercapnia \[arterial carbon dioxide tension(PaCO2) \>50 mmHg\];
* Significant cardiac history.
Use of Blood and Plasma in Norwegian Physician-staffed Helicopter Emergency Medical System

The main objective of this study is to evaluate the use of RBC, FDP, WB in the treatment of exsanguinating patients by physician-staffed emergency medical services in Norway, with focus on prehospital transfusion complications and safety.

This study evaluates prehospital transfusion therapy in exsanguinating patients treated by physician-staffed emergency medical services in Norway, with the following main questions:

I. Are out-of-hospital transfusions associated with an increase in adverse transfusion events compared to inhospital transfusions?

II. Is out-of-hospital physician administration of plasma or blood products in exsanguinating patients feasible?

III. Are patients in need of blood product transfusion possible to identify and transfuse in the prehospital phase/environment?

IV. Are out-of-hospital transfusion practices associated with increased waste of blood products?

All patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products will be included, if they fulfill the listed criteria below:

* Patients with mechanism of injury compatible with severe haemorrhage and/or haemorrhagic shock (e.g. penetrating torso injury, visible massive bleeding)
* Radial pulse \> 100 beats/min or absent/weak radial pulse
* Systolic blood pressure (SBP) \< 90 mmHg
* Altered mental status (reduced GCS) in the absence of head injury or known intoxication

Patients with known previous serious allergic reactions to blood product transfusions or patients who refuse blood products on religious grounds (e.g. Jehovah´s Witness) will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* All patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products according to listed indicators below:

  * Patients with mechanism of injury compatible with severe haemorrhage and/or haemorrhagic shock (e.g. penetrating torso injury, visible massive bleeding)
  * Radial pulse \> 100 beats/min or absent/weak radial pulse
  * Systolic blood pressure (SBP) \< 90 mmHg
  * Altered mental status (reduced GCS) in the absence of head injury or known intoxication

Exclusion Criteria:

* Patients with known previous serious allergic reactions to blood product transfusions
* Patients who refuse blood products on religious grounds, e.g. Jehovah´s Witness
A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

The main purpose of this study is to evaluate the effectiveness and safety of gemcitabine-carboplatin plus necitumumab in chemotherapy-naïve participants with locally advanced or metastatic squamous non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have confirmed diagnosis of locally advanced or metastatic NSCLC in Cohort 1 and metastatic NSCLC in Cohort 2, predominantly squamous histology. Squamous NSCLC diagnosis must be confirmed by histology or cytology local pathology report.
* Participants in Cohort 1 are required to have epidermal growth factor receptor (EGFR) protein expressing tumor (defined by local immunohistochemistry test). This is not required for participants in Cohort 2.
* Measurable disease at the time of study entry as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
* The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1
* Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy: Biologic agents (for example, antibodies) and Immunotherapy ≥4 weeks; Chest radiotherapy ≥4 weeks; Major surgery, excluding biopsy ≥4 weeks)
* The participant has archived tumor tissue available for biomarker analyses.
* Participants in Cohort 2 are required to have received 1 prior single-agent immune checkpoint inhibitor for squamous NSCLC.

Exclusion Criteria:

* The participant has nonsquamous NSCLC
* The participant has received prior anticancer therapy targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor.
* The participant has received previous chemotherapy (including concurrent chemoradiation) for advanced NSCLC (participants who have received neo-adjuvant and/or adjuvant chemotherapy are eligible if the last administration occurred at least 1 year prior to start of therapy).
* The participant has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants.
* The participant has a bleeding tumor.
* The participant has a history of arterial or venous thromboembolism within 3 months prior to study enrollment.
* The participant has a history or evidence of current clinically-relevant coronary artery disease of current ≥ Class III as defined by Canadian Cardiovascular Society Angina Grading Scale (Campeau 1976) or congestive heart failure of current ≥ Class III as defined by the New York Heart Association.
* The participant has experienced myocardial infarction within 6 months prior to study enrollment.
Assessing Continuous Glucose Monitors in Healthy Children

Continuous glucose monitors may be useful in the treatment of children with Type 1 diabetes mellitus. The purpose of this study was to determine whether two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2TM Biographer (GW2B), are sufficiently accurate to use in future studies to characterize glucose levels in children.

The characterization of glucose levels in healthy children during day and nighttime is critical to the interpretation of glucose levels in diseases such as diabetes. This study was conducted by the DirecNet Study Group to determine whether two FDA-approved continuous glucose monitors are sufficiently accurate.

The study was conducted at five clinical centers and enrolled approximately 20 healthy children (ages 7 to 17 years old) who did not have Type 1 or Type 2 diabetes nor a history of the disease in their immediate families. Each participant was hospitalized for approximately 26 hours to assess the accuracy of the continuous glucose monitors compared with serum glucose determinations.

Eligibility Criteria:
Inclusion Criteria

* Weight \>= 16.0 kg (35 lbs)
* Body mass index between the 10th to 90th percentile for age and sex
* HbA1c within normal limits
* Hematocrit within normal limits

Exclusion Criteria

* History of diabetes
* History of positive islet cell antibody testing
* Family history of Type 1 or Type 2 diabetes in a sibling or parent
* Medication use of any type in the 7 days prior to study entry
* Skin abnormalities contraindicating device use
GCC19CART for Patients With Metastatic Colorectal Cancer

Study ICT-GCC19CART-US-001 (CARAPIA-1) is a Phase 1 study evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of GCC19CART in subjects with relapsed or refractory metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years old
* Clinical and histopathological diagnosis of metastatic colorectal cancer
* Guanylate Cyclase (GCC) positive disease as determined by immunohistochemistry (IHC). Positivity on staining of archival tumor tissue is adequate.
* Limited liver disease (less than 7 lesions with largest lesion less than 3 cm)
* No surgical options with curative intent.
* Received prior therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy in the advanced or metastatic setting, an anti-vascular endothelial growth factor (anti-VEGF) biological therapy if not contraindicated, and if RAS wild-type an anti-epidermal growth factor receptor (anti-EGFR) therapy in a manner consistent with National Comprehensive Cancer Network (NCCN) guidelines. Treatment must have been discontinued for disease progression or intolerance to therapy.
* Have at least one extracranial measurable target lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard.

Exclusion Criteria:

* Subjects with tumor lesion(s) in a location that may cause perforation of an organ or structure (such as the digestive track, urinary bladder, or blood vessel) with GCC19CART therapy.
* No active infectious diseases or comorbid conditions that would interfere with safety or data quality.
* Subjects with active infection requiring systemic therapy or causing fever (temperature \> 38.1˚C) or subjects with unexplained fever (temperature \> 38.1˚C) within 7 days prior to enrollment (leukapheresis) and reconfirmed prior to the day of investigational product administration.
* Pregnant or breast-feeding women

Other protocol defined Inclusion/Exclusion criteria may apply
Impact of the Techniques for Intrathoracic Esophagogastric Anastomosis on Outcome in Ivor-Lewis Oesophagectomy

The purpose of this study is to determine the safety and efficacy of the side-to-side stapled intrathoracic esophagogastric anastomosis in Ivor-Lewis Oesophagectomy.


Eligibility Criteria:
Inclusion Criteria:

* Cancer of the distal esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III.
* Received no previous treatment for esophageal cancer
* Adequate bone marrow, liver and kidney function
* Patients must be able to understand the nature consent of the study and give written informed consent.

Exclusion Criteria:

* Age \< 18 years
* History of significant heart disease
* Inoperable on the basis of co-existent medical problems
ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors

This is a Phase 1b/2, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors.

This is a Phase 1b/2, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of ADG126-Pembrolizumab combination regimens in patients with advanced/metastatic solid tumors.

Study drug ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age at the time of informed consent.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
3. Wash out period from previous antitumor therapies
4. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
5. Adequate organ function.
6. An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable.
7. For Dose Escalation Phase Only: Patients with advanced or metastatic solid tumors, histologically or pathologically confirmed, who have progressed after all standard therapies, or for whom no further standard therapy exists.

   Dose Expansion Phase Only: Tumor tissues (archived or fresh biopsy) before treatment are required for all patients. Biopsies and tumor tissues after treatment are optional but preferred for patients with MSS-CRC and 2L anti-PD-1/anti-PD-L1 experienced NSCLC.
8. No prior immunotherapy

Exclusion Criteria:

1. Pregnant or breastfeeding females.
2. Childbearing potential who does not agree to the use of contraception during the treatment period.
3. Treatment with any investigational drug within washout period.
4. Prior treatment with an anti-CTLA-4 therapy.
5. History of significant immune-mediated AE.
6. Central nervous system (CNS) disease involvement.
7. History or risk of autoimmune disease.
8. Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (\>10 mg/day prednisone or equivalent).
9. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
10. Major surgery within 4 weeks prior to the first dose of the study drug.
11. Has had an allogeneic tissue/solid organ transplant.
12. Has received a COVID-19 vaccine within 7 days prior to the first dose of study treatment. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Administration of killed vaccines are allowed.
13. A positive COVID-19 test within 14 days of Cycle 1 Day 1.