cyrilzakka/clinical-trials huggingface dataset:
Circulating Biomarkers in the Development of Type 1 Diabetes

More than 100 million U.S. adults are now living with diabetes or prediabetes. Investigators still do not fully understand how diabetes develops and how the disease worsens. Insulin is a hormone that helps the body use sugar as a fuel and control blood-sugar levels. People with diabetes have problems making insulin. This is because their insulin-producing beta cells -in the pancreas-are damaged or destroyed. A biomarker is a biological molecule (such as DNA, RNA (the genetic material of cells) or protein) that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker can be measured and found in blood and/or other body fluids (such as saliva and urine). Understanding the biology of beta cells could help find diabetes-related biomarkers. The discoveries from this research could help with early diagnosis of diabetes and lead to the creation of therapies for treating diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Documented informed consent/ assent from the subject
* ONE of the following:

  * Type 1 diabetes patients (including pediatric patients) -OR-
  * Adult type 2 diabetes patients -OR-
  * Volunteers who are islet auto-antibody positive (i.e. insulin, GAA, IA-2, IAA and ZnT8 antibodies) with HbA1c ≤ 5.6% (including pediatric patients)-OR-
  * Adult participants with clinical diagnosis of high blood sugar (i.e. HbA1c of 5.7% to 6.4%)-OR-
  * Adult control subjects with HbA1cc ≤ 5.6%
* Weight ≥ 30 kg
* Willingness to: Provide blood sample(s) and if applicable: permit medical record/ clinical laboratory result review

Exclusion Criteria:

* Control subjects must not have any chronic conditions or have undergone cellular, tissue or organ transplant
* Sickle cell disease or anemia (exception: anemia that is corrected with treatment and source documents confirm corrected blood parameters current within 6 months of blood draw)
* Active infection
* Active malignancy (i.e., currently undergoing treatment)
* Immunomodulatory therapy within 1 year of planned blood draw (may include immune checkpoint inhibitors, thalidomide, lenalidomide, pomalidomide, imiquimod, Bacillus Calmette-Guérin, and cytokines/ growth factors (e.g. interferons, interleukins)
* Type 1 diabetes only: polyclonal regulatory T cell and/or dendritic cell therapy
* Bleeding disorder
* Women of childbearing potential: Pregnant/ nursing (Note: Eligibility may be deferred per blood donation timelines for pregnancy/nursing)
* Diabetic patients only: Any clinical condition that might be adversely affected by the removal of up to 100 mL of blood
* An employee who is under the direct/ indirect supervision of the PI/ a co-investigator/ the study manager
* A direct study team member
Construction of Perioperative Medical Data Platform and Its Typical Practice to Predict Postoperative Acute Moderate to Severe Pain With Machine Learning Models

Data intelligence platform was widely used to facilitate the process of clinical research. However, a platform that integrates natural language processing (NLP) and machine learning (ML) algorithms has not been reported in perioperative medical management.


Eligibility Criteria:
Inclusion Criteria:

* Patients were included if they were above 18 years old, undergoing non-local anesthesia surgery.

Exclusion Criteria:

* The basic information such gender, age, height, weight, and body mass index (BMI) were missing.
* Patients undergoing day surgery, with a history of multiple operations, or entering ICU after surgery, and losing the NRS score during movement at 24h after surgery.
Oxidative Stress and Mitochondrial TERT in Papillary Thyroid Cancer.

Oxidative stress (OS) could be involved in the progression of papillary thyroid cancer (PTC). Indeed, thyroid differentiation genes are silenced by a mechanism controlled by NOX4-derived OS. On the other hand, TERT contributes to mitochondrial OS protection, which could increase the resistance of cancer cells to therapeutic agents. The investigators aim to address the role of OS and mitochondrial TERT in the progression and therapeutic resistance of PTC. OS and TERT subcellular localization will be investigated in 150 PTCs and correlated to the genetic and expression profile of the tumors and to the clinical and prognostic features of the patients. Mechanisms implicated in TERT mitochondrial migration and the contribution of mitochondrial TERT to tumor progression will be investigated in cancer cell lines and primary cell cultures. This study will allow to identify OS as a marker of therapeutic resistance in PTC and will open new opportunities for the development of novel treatments targeting ROS generation/TERT nuclear export.


Eligibility Criteria:
Inclusion Criteria:

* Patients with papillary thyroid cancer
* Patients whose tumor and contralateral healthy tissues can be collected for the analyses

Exclusion Criteria:

* patients who did not provide consent
* patients lost at follow-up
* tissues not adequate for the analyses
The Effectiveness of Titanium-Prepared Platelet-Rich Fibrin on Angiogenic Biomarkers in Gingival Crevicular Fluid

This study investigates the effect of titanium-prepared platelet-rich fibrin (T-PRF) treatment on the angiogenic biomarkers in gingival crevicular fluid (GCF) in infrabony defects of patients with chronic periodontitis. In each patient, the infrabony defect of one side of arch was designated as control group (allograft), while the infrabony defect on the contralateral side of same arch was designated as test group (allograft+T-PRF).

Platelets are the cells initiating the wound healing and also supporting it by secreting various growth factors actively. These growth factors released by platelets act the increase of connective tissue healing, bone regeneration and repair, fibroblast mitogenesis, wound angiogenesis and the activation of macrophages by stimulating cell proliferation signals.

Titanium-prepared, platelet-rich fibrin (T-PRF), is a new platelet concentrate, is formed in titanium tubes may be more efficient to activate platelets in comparison with glass tubes.The titanium tubes is utilized to refrain any inverse effects of glass tubes and also silica.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Chronic Periodontitis
* The presence of two or three-wall intrabony defects≥3 mm deep along with an interproximal probing depth ≥5 mm after non-surgical periodontal therapy

Exclusion Criteria:

* Systemic illnesses
* Any medications known to affect the outcomes of periodontal surgery
* Pregnancy and lactation
Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.

The purpose of this study is to determine whether SLIT tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT tablets on allergic rhinitis symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients 18-50 years old
* grass pollen rhinoconjunctivitis of at least 2 years.
* positive specific skin prick test and a specific IgE dosage level of at least 0.70 kU/L at screening.
* written consent
* a positive response to the baseline challenge test (RTSS reaches 7 at one time-point at least during baseline challenge)

Exclusion Criteria:

* Allergic rhino-conjunctivitis due to a co-sensitisation, likely to significantly change the symptoms of the subject throughout the study
* Asthma requiring treatment other than short-acting beta-2 inhaled agonists.
* Desensitisation treatment for grass pollen in the previous five years and current immunotherapy with another allergen.
Durolane Versus Methylprednisolone in Knee Osteoarthritis

The primary objective is to determine whether Durolane is non-inferior to methylprednisolone, as assessed by level of pain, when each are given as single intra-articular injections for the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subject (female or male) 35-80 years of age
* Unilateral knee pain
* Radiographic evidence of OA
* WOMAC pain score of 7-17
* Subject normally active
* Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies);
* Subject cooperative and able to communicate effectively with the investigators;
* Body mass index ≤ 40 kg/m2;
* Signed informed consent obtained.

Exclusion Criteria:

* Knee effusion
* Contralateral knee OA
* Clinically significant joint pain from joints other than the knee
* Previous intra-articular steroid injection into the study knee within the last 3 months;
* Previous intra-articular HA injection into the study knee within the last 9 months;
* Previous allergic type reaction to a HA product, a steroid, or lidocaine/related anesthetics;
* Treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit;
* Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months;
* Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months
* Change in physical therapy for the knee within the last three months
* Arthroscopy or other surgical procedure in the study knee within the past 12 months;
* Any planned arthroscopy or other surgical procedure during the study period;
* Previous history or presence of active septic arthritis
* Active skin disease or infection in the area of the injection site;
* Systemic active inflammatory condition or infection
* Bleeding diathesis or use of anticoagulants
* Current uncontrolled diabetes mellitus;
* Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion
* Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception;
* Involvement in other clinical trials
The Effect of Breathing Exercises in Addition to Conventional Treatment in Frozen Shoulder Patients

The study aimed to investigate the effect of breathing exercises in addition to conventional treatment on pain, normal joint movement and quality of life in patients with frozen shoulder.

A simple random number table will randomly divide participants into two groups. The study group (20 participants) will be given 15 sessions of respiratory exercises in addition to the 15 sessions of physiotherapy provided routinely for treatment. The control group (20 participants) will receive 15 sessions of physiotherapy services in addition to the routine 15 sessions of the physiotherapy department.

After completing the demographic information form, a visual analog scale will be used for pain intensity, a Baseline digital goniometer will be used to measure the normal joint range of the shoulder girdle, and a Short form SF-36 will be used for quality of life. All participants will be evaluated before and after 15 sessions. The same assessments will be performed in both groups. The evaluations are expected to last 40 minutes in total.

The study group (20 participants) will be given 15 sessions of respiratory exercises in addition to the 15 sessions of physiotherapy provided routinely for treatment. The control group (20 participants) will receive 15 sessions of physiotherapy services in addition to the routine 15 sessions of the physiotherapy department.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Having a diagnosis of a frozen shoulder,
* Volunteering to participate in the study
* Not having any problem that may prevent respiratory exercise.

Exclusion Criteria:

* Not volunteering to participate in the study,
* Having undergone upper extremity surgery,
* History of previous shoulder surgery, shoulder subluxation or dislocation,
* Any mental or sensory problems,
* Acute infection or chronic disease of neurological, psychiatric, orthopedic, cardiological, rheumatological, etc. origin,
* Having any respiratory disease
Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease

The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.


Eligibility Criteria:
Inclusion Criteria:

* Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis
* Anemic
* Currently on erythropoietic therapy
* Controlled hypertension
* Clinically stable
Evaluation of Meniscal Extrusion by Dynamic Ultrasonography in Patients With Ostearthritis

This is a diagnostic, open-label, single-center interventional study. The aim of the study is to evaluate the relationship between medial and lateral meniscus extrusion determined by dynamic ultrasound study and bone edema assessed by MRI study in patients with knee OA.

As a secondary objective, the correlation of the above parameters with the patient's symptomatology assessed by subject clinical questionnaires will be evaluated.

Patients with a diagnosis of knee OA will be included in a study involving evaluation of the correlation between meniscal extrusion assessed by dynamic ultrasonography and bone edema assessed on MRI. A total of 202 patients will be included, who, after providing their signed informed consent to participate in the study, will undergo dynamic ultrasonography. After giving signed consent to participate in the study, the patient will undergo the following examinations::

* ultrasound evaluation for assessment of possible meniscal extrusion;
* At the same time as the ultrasound examination, subjective questionnaires will be administered to patients.Recent radiological examinations of the patients or from the patient's medical record will be collected during or before the diagnostic investigation.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years;
2. Signs and symptoms of degenerative pathology of knee cartilage;
3. Patients with Radiographic (X-ray or MRI) signs of OA (K-L grade 0-4); 3.
4. Cooperative patients with pain that does not prevent orthostatism
5. Ability and consent of patients to actively participate in clinical follow-up;
6. Recently performed MRI (maximum 1 month).

Exclusion Criteria:

1. Patients unable to express consent;
2. Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
3. Patients undergoing knee surgery in the previous 12 months;
4. Patients with malignant neoplasms;
5. Patients with rheumatic diseases;
6. Patients with a history of total/subtotal meniscectomy;
7. Patients with symptomatology such that a dynamic examination in orthostatism is not possible; 7.
8. Patients abusing alcoholic beverages, drugs or medications;
9. Body Mass Index \> 40;
10. Pregnant or lactating women;
11. Patients with axis deviation \> 5°.
Artificial Intelligence for Determination of Gastroscopy Surveillance Intervals

The purpose of this study is to develop and validate a clinical decision support system based on automated algorithms. This system can use natural language processing to extract data from patients' endoscopic reports and pathological reports, identify patients' disease types and grades, and generate guidelines based follow-up or treatment recommendations


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 - 80 years
* Patients underwent endoscopic examination

Exclusion Criteria:

* Patients with the contraindications to endoscopic examination
* Patients with imcomplete examination information
* Patients undergo endoscopy for therapy
* Patients have history of upper gastrointestinal surgery
* Patients with duodenal or Laryngeal neoplasms
* Patients with gastrointestinal submucosal tumor
Effect Of Pilates On Postural Control And Balance In Children With Down's Syndrome

Down's syndrome (DS) is a genetic condition characterized by the presence of an extra chromosome 21, leading to various clinical symptoms. Individuals with DS often experience challenges in balance, posture, and motor skills, which can impact their daily activities. Pilates activities focus on the concept of control of muscles. Pilates increases trunk flexibility, abdominal and core strength and endurance, and deep core muscle activation hence improving balance and posture.

The study will be randomized controlled trial used to evaluate the effectiveness of pilates on posture and balance in children with down's syndrome. Subjects with down's syndrome meeting the pre-detremined inclusion and exclusion criteria will be divided into two groups using non-probability sampling technique. Assessment will be done using Pediatric balance scale(PBS) and Timed up and go test (TUG).). Control group will receive regular physical therapy with balance training and experimental group will receive regular physical therapy+ Pilates.

Eligibility Criteria:
Inclusion Criteria:

* Down's syndrome children with age between 6 and 12 years.
* The ability to execute required motor skill proficiency and executive function tests.
* The capacity to walk and stand by oneself

Exclusion Criteria:

* • Children who are not able to comprehend commands.

  * Associated cardiovascular and orthopedic condition.
  * Loss of functional hearing and vision or a related respiratory disease.
  * History of traumatic injury
  * History of previous surgery
  * Inability of parents to understand the procedure and their unwillingness to participate
Management of Incidentally Discovered Pancreatic Cysts

The purpose of this study is to determine the natural history of pancreatic cysts and to determine if these cysts can be effectively treated with a less invasive therapy (ethanol injection vs periodic imaging) rather than surgical resection

The appropriate management of patients with cystic lesions of the pancreas is controversial. The identification of small asymptomatic pancreatic cysts is increasing due to an improvement in the quality of radiologic imaging and the frequency that imaging is obtained. However, the natural history of these lesions is unknown1. The current consensus guidelines established at the International Consensus Conference in Sendai, Japan in 2005 suggest that branch chain IPMNs and mucinous cystic neoplasms that cause no symptoms, measure \<3cm, and have no nodules can be observed with periodic imaging. However, the time course of these pre malignant mucinous lesions, intraductal papillary mucinous neoplasms (IPMN) or mucinous cystadenomas, from benign to malignant has not been determined. Due to the unknown natural history, and diagnostic uncertainty, some authors have recommended routine resection2, 3. Resection, despite improvements in surgical outcomes after pancreatectomy at high volume centers, carries a mortality and morbidity of 1-6% and 35-51%, respectively4-6. More recently studies are reporting a more selective approach to avoid the risk of operation in patients with benign lesions7. Improved radiographic and endoscopic studies have been able to identify some lesions with increased malignant potential8, 9. Thus, most patients will undergo pancreas specific radiologic imaging and endoscopic ultrasound with cyst aspiration. Since the natural history of cystic lesions is poorly understood no clear guidelines for surgical resection have been established. Some of the cysts will grow over time, with an increase in the cumulative risk of malignancy. Therefore, the therapeutic alternatives are to wait and watch for a change in the cyst morphology or to treat preemptively, which has been restricted to surgical resection. Based on the pilot study performed by Dr. William Brugge, at Massachusetts General Hospital, ethanol lavage of pancreatic cysts is safe and will result in a decrease in cyst diameter in 61% of patients. Additionally, if patients elect to not be treated preemptively it is unclear how to best follow these patients in terms of the type and the frequency of follow up studies.

Eligibility Criteria:
Inclusion Criteria:

* Cyst between 1-3cm
* No evidence of a mural nodule, solid component, or septations in the cyst
* For patients with multiple cysts, the largest will be evaluated

Exclusion Criteria:

* Any imaging or cytology concerning for malignancy
* Pancreatic Pseudocyst
* Gross Cyst \>3cm as measured on MRCP
* Clinically active pancreatitis or serum amylase or lipase \>3x upper limit of normal
* Coagulopathy (INR\>1.5, PTT\>100, Platelets\<50K)
* Inability to tolerate conscious sedation and endoscopy
* Rated ASA IV or greater
* Prior EUS and aspiration of the pancreatic cyst
* Breast feeding
* Pregnancy
Safety and Efficacy of Radiation Plus TACE and Lenvatinib in Advanced HCC With PVTT

This is a multicentri prospective cohort study to investigate the safety and efficacy of external beam radiation (RT) combined with transarterial chemoembolization (TACE) and lenvatinib vs TACE and lenvatinib in the treatment of advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).


Eligibility Criteria:
Inclusion Criteria:

1. age 18-75 years;
2. histologically or cytologically or clinically confirmed diagnosis of HCC;
3. presenting with PVTT and at least one measurable intrahepatic lesion on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST); an intrahepatic lesion consisting of a single tumor (≤ 10.0 cm) or multiple tumors (≤ 3 foci) with the tumor burden \< 50%;
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
5. Child-Pugh class A or B;
6. life expectancy of at least 3 months;
7. satisfactory blood, liver, and kidney function parameters. The acceptable blood, liver, and kidney parameters were (1) neutrophil count ≥ 1.5 × 109/L; (2) platelet count ≥ 60 × 109/L; (3) hemoglobin concentration ≥ 90 g/L; (4) serum albumin concentration ≥ 30 g/L; (5) bilirubin ≤ 50 μmol/L; (6) AST and ALT \< 5 × upper limit of normal (ULN) and alkaline phosphatase \< 4 × ULN; (7) extended prothrombin time \< 6 seconds of ULN; and (8) serum creatinine \< 1.5 × ULN.

Exclusion Criteria:

1. history of liver and adjacent tissue radiation;
2. medical history of hepatic decompensation, such as hepatic encephalopathy and esophageal or gastric variceal bleeding;
3. extrahepatic spread;
4. combination with other malignant diseases;
5. contraindications for TACE;
6. pregnant and lactating women;
7. severe dysfunction of the heart, kidney, or other organs;
8. hypersensitivity to intravenous contrast agents;
9. with HIV, syphilis infection;
10. allogeneic organ transplant recipients;
11. suffering from mental and psychological diseases may affect informed consent;
12. unable to take oral medication;
13. active gastric or duodenal ulcers within 3 months before enrollment.