cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years

The efficacy of long-term treatment with different GLP-1RA (Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc.) was evaluated through 1-4 years of follow-up, and the effects of long-term treatment on blood glucose and body fat of patients.

At present, there has been no evaluation on the efficacy of long-term treatment of different GLP-1RA (Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc.), and the effects of long-term treatment on patients' blood glucose and body fat. This study intends to follow up for 1-4 years. To observe the effects of different GLP-1RA on body fat, insulin resistance, body weight, blood glucose, blood lipids, stomach volume, etc., in patients with type 2 diabetes, and explore the factors affecting the efficacy, so as to provide more evidence-based medical evidence for drug treatment and benefit patients.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed type 2 diabetes according to the 1999 WHO standards;
2. received at least 8 weeks of simple diet control and physical exercise before screening; Patients with type 2 diabetes who were treated with stable hypoglycemic drugs and had inadequate glycemic control within 8 weeks prior to screening;
3. HbA1c≥7.5%；
4. BMI\>24kg/m2;
5. Subjects agree to maintain a scientific diet and exercise habits throughout the study, and regularly self-monitor and record blood sugar (SMBG);
6. Be willing to sign written informed consent and comply with the study protocol

Exclusion Criteria:

1. Use of any of the following drugs or treatments in the 3 months prior to screening: treatment with GLP-1RA, GLP-1 analogue, DPP-4 inhibitor, or any other incretin analogue;
2. Long-term (more than 7 consecutive days) intravenous administration, oral administration, or intra-articular administration of corticosteroids within 2 months prior to screening;
3. Use of weight control drugs or surgery that can lead to weight instability within 2 months before screening, or are currently in a weight loss program and not in the maintenance stage:
4. History of acute and chronic pancreatitis; A history of medullary C-cell carcinoma, MEN (multiple endocrine tumors) 2A or 2B syndrome, or related family history;
5. Clinically significant gastric emptying abnormalities;
6. tumors of any organ system that have been treated or not treated in the 5 years prior to screening;
7. had received coronary angioplasty, coronary stenting, or coronary artery bypass within 6 months before screening. Negligent compensatory heart failure (NYHA rating III and IV), stroke or transient ischemic attack, unstable angina, myocardial infarction, persistent and clinically significant arrhythmia;
8. Acute metabolic complications occurred within 6 months before screening;
9. Before screening, any of the laboratory test indicators meet the following criteria: glutamic-pyrugenic transaminase \>2.5 times or ASpartate transaminase \>2.5 times; eGFR \<45ml/min/1.73m2; Fasting glycerin tricol \>5.64mmol/L.
A Clinical Study on LM103 for the Treatment of Advanced Solid Tumors

This study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients . The research treatment includes fludarabine and cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and IL-2 therapy.


Eligibility Criteria:
Inclusion Criteria:

1. The expected survival time is not less than 3 months.
2. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
3. Patients with advanced solid tumors confirmed by histology or cytology: advanced Melanoma, cervical cancer/ovarian cancer, head and neck squamous cell cancer, non-small cell lung cancer, esophageal cancer and other solid tumors that have failed standard treatment regimens, cannot tolerate standard treatment, refuse or do not have standard treatment regimens available.
4. The patient has lesions that can be used for surgical resection (\>1.5 cm3) or biopsy puncture (no less than 6 lesions) for TILs collection.
5. At least one measurable lesion as the target lesion after collecting tumor tissue from the patient (RECIST v1.1 criteria).
6. Laboratory tests results during the screening period indicate that the subjects have sufficient organ function.

Exclusion Criteria:

1. Have a medical history of other malignant tumors other than the disease under study in the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to thyroid cancer, cervical Carcinoma in situ, basal or squamous cell skin cancer or Ductal carcinoma in situ of the breast treated by radical surgery).
2. LM103 received systematic Sex therapy of antineoplastic drugs (including chemotherapy, small molecule targeted drug therapy, Hormone replacement therapy, etc.), or local antineoplastic therapy (such as radiotherapy, palliative radiotherapy for bone metastases\>2 weeks before the start of the study and intracranial stereotactic radiotherapy or resection of a single brain metastasis\>3 weeks before the start of the study were acceptable) within 4 weeks before LM103 infusion; Or received clinical investigational drugs or equipment treatment.
3. Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been determined by the researchers to be irreparable and level 2 hypothyroidism for a long time).
4. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
Biomarkers for Postoperative Myocardial Infarction in Cardiac Surgery.

Myocardial infarction and subsequent myocardial injury after cardiac surgery occurs in 7-15% of patients undergoing cardiac surgery and is associated with an increased length of stay, and reduced short- and long-term survival. Cardiac troponin is considered to be a cornerstone in the diagnosis of a myocardial infarction. Heart-type Fatty Acid-Binding Protein (H-FABP) is a new sensitive biomarker for myocardial injury. The effectiveness of using the combination of H-FABP with Troponin to diagnose myocardial injury within 6 hours after the onset of ischemia is well reported. Previous studies in non-surgical patients have associated increased H-FABP with an increased risk of subsequent death and major cardiac events. The prognostic value in cardiac surgery patients has not been studied extensively.

The objective is to estimate the association between biomarkers of myocardial injury and myocardial infarction in patients undergoing cardiac surgery. Myocardial infarction will be established with both a new and very early marker of myocardial injury (Heart-type Fatty Acid Binding Proteins) as well as to a known early marker of such injury (Cardiac troponin).

Specific aims:

1. To obtain an estimate of the association between a new very early marker of postoperative myocardial injury H-FABP and postoperative myocardial infarction.
2. To obtain an estimate of the association between cTn-I and postoperative myocardial infarction.
3. To obtain an estimate of the correlation between H-FABP elevation and cTn-I elevation in patients undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* isolated coronary artery bypass grafting
* isolated valve surgery
* combined coronary artery bypass grafting and valve surgery

Exclusion Criteria:

* emergency surgery patients
* (suspected) sepsis
* pulmonary embolism
* renal failure (Glomerular filtration rate \< 40 ml/min)
* off pump cardiac surgery
Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD

Invasive ventilation(IV) remains one key cornerstone to reduce neonatal mortality for preterm infants with respiratory distress syndrome(RDS) and/or acute respiratory distress syndrome(ARDS). However, it is also related to increased risks of ventilator-associated lung injury and escalation of pulmonary inflammation, and which finally result in bronchopulmonary dysplasia (BPD). Early weaning from IV in newborn infants with BPD is therefore a key procedure to reduce these risks above.

Supplying with the combined advantages of NCPAP and high-frequency oscillatory ventilation (HFOV) with high carbon dioxide(CO2) removal, no need for synchronisation, non-invasion, less volume/barotraumas, and increased functional residual capacity, nasal HFOV(NHFOV) was considered as a strengthened version of NCPAP. Furthermore, the superimposed oscillations of NHFOV could avoid gas-trapping, and allowed to obviously up-regulate mean airway pressure (MAP) more than NCPAP. Thus, NHFOV might be more beneficial as post-extubation respiratory support strategy to avoid re-intubation and subsequent complications and/or sequelae as compared with NCPAP in preterm infants. Nowadays, NHFOV was increasingly used in neonatal intensive care unit (NICU) around the world due to its convenient operation. A retrospective review has reported the beneficial effects of NHFOV in preterm infants as a remedial measure after failing to other noninvasive modes, including reducing the number of apneas, bradycardias or oxygen desaturations. However, there were rare randomized controlled studies comparing NHFOV with NCPAP in preterm infants with BPD.

We have found that NHFOV is superior to NCPAP in avoiding re-intubation in very preterm infants with the first extubation. The purpose of the present study was to compare NHFOV with NCPAP as post-extubation respiratory support strategies on the need for endotracheal ventilation, as well as pressure of CO2(PCO2) level in preterm infants with BPD.

Eligibility Criteria:
Inclusion Criteria:

Eligibility requirements for neonates:

* The gestational age is less than 32 weeks
* The preterm neonates are diagnosed with BPD and need invasive ventilation
* Extubation and subsequent noninvasive ventilation is ready to be carried out

Exclusion Criteria:

one of the following conditions is needed:

* there were no intraventricular hemorrhage(IVH) grades 3 or 4
* major congenital anomalies
* parents' decision not to participate
FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty

This study was to compare the study drug BAY1213790 to existing therapies, i.e. enoxaparin or apixaban, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). The study was open-label, but observer-blinded for the different doses of BAY1213790. This means that it was known which treatment was given, but it was not known which dose of BAY1213790 was administered.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years and undergoing elective primary, unilateral Total Knee Arthroplasty (TKA)
* Women of non-childbearing potential

Exclusion Criteria:

* High risk for clinically significant bleeding
* Prior deep vein thrombosis
* Body weight above 135 kg
* Creatinine clearance below 60 ml/min
* Recent (\<6 months) myocardial infarction or ischemic stroke
* Contraindication listed in the local label of the comparator treatments
* Requirement for full dose anticoagulation or dual antiplatelet therapy
Prevention of Type 2 Diabetes Amongst South Asians With Central Obesity and Prediabetes

The investigators' general goal is to identify approaches to risk stratification and health promotion through lifestyle modification that are acceptable, effective and efficient for prevention of T2D in South Asian communities from diverse settings.

The specific aims of the proposed iHealth-T2D study are:

1. Determine whether intensive lifestyle modification vs usual care reduces risk of T2D (primary endpoint) amongst South Asians with i. central obesity; ii. prediabetes and iii. overall (with central obesity and / or obesity).
2. Investigate secondary endpoints, including health gains in family members. Identify social, demographic and environmental factors influencing primary and secondary endpoints.
3. Carry out a health economic analysis of lifestyle modifications vs usual care for prevention of T2D on the Indian subcontinent and Europe. Quantify the cost-effectiveness of screening by waist circumference vs HbA1c.

Eligibility Criteria:
Inclusion Criteria:

* Waist circumference≥100cm OR HbA1c≥6.0%
* South Asian, Male or Female, and age 40-70 years

Exclusion Criteria:

* Known type 1 or 2 diabetes
* Fasting glucose≥7.0 mmol/L or HbA1c ≥6.5%
* Normal or underweight (body mass index\<22kg/m2)
* Pregnant or planning pregnancy
* Unstable residence or planning to leave the area
* Serious illness
* Lack of capacity to consent
Aliskiren and Muscle Sympathetic Nerve Activity

The central hypothesis of this project is that Aliskiren causes a substantial decrease in MSNA in hypertensive patients with CKD.

Cardiovascular (CV) morbidity and mortality are frequently occurring problems in chronic kidney disease (CKD) patients. Apart from the so called traditional risk factors, also risk factors more or less specific to CKD contribute in the pathogenesis of these problems. There is strong evidence that the sympathetic hyperactivity, which often characterizes CKD, is one such factor. Previously, we have shown that angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB) reduce but not normalize this sympathetic hyperactivity. We re-analysed the cohort of patients who were investigated in the past and subsequently treated according to present guidelines. The results show that, despite of treatment, the unfavourable relation between sympathetic hyperactivity and clinical outcome still exits. This might mean that treatment is insufficient. In present study, we want to study the effect of Aliskiren 300mg on sympathetic nerve activity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable chronic kidney disease and hypertension: i.e. using antihypertensive drugs and/or blood pressure \> 145/90 mmHg when off medication.
* Patients on ACE inhibitor or ARB

Exclusion Criteria:

* Patients with diabetes mellitus
* Patients on renal replacement therapy
* Pregnant patients Using of antihypertensive which cannot be stopped
* Patients on immunosuppressive therapy and active nephrotic syndrome
Evaluation of the Initial Color Match of Different Single-shade Composites

The aim of this study was to evaluate the initial colour match of anterior non-carious cervical lesions restored with different single-shade resin composites, namely Omnichroma (Tokuyama) and Charisma Topaz One (Kulzer).

Colour selection for composite restorations is a challenging process influenced by a number of environmental and operator factors. The polychromatic structure of natural teeth presents a challenge to shade selection. Consequently, the prevailing trend towards simplification of shade matching has led to the emergence of single-shade universal composites. Single-shade universal composites are able to replicate the natural colour of teeth by capturing the structural colour based on the size of the filler particles. Unlike other materials, it does not require the use of additional dyes or pigments. The blending, colour induction and colour assimilation effects of resin composites are collectively referred to as the chameleon effect. This phenomenon allows resin-based restorative materials to achieve a shade that closely resembles the colour of the surrounding tooth structure. The intelligent monochromatic composite makes shade selection easier for the clinician and provides a quick and easy way to create aesthetic restorations. Its distinctive character reduces confusion and potentially saves time in the clinic. However, the effectiveness of this material in matching different shades of natural teeth remains uncertain, and there is a paucity of clinical evidence on the efficacy of its colour-matching capabilities in dental restorations.

Eligibility Criteria:
Inclusion Criteria:

* Maintain satisfactory oral hygiene
* Have healthy gingival tissues
* Presence of an anterior non-carious cervical lesion approximately 5 m wide

Exclusion Criteria:

* Presence of caries
* Signs of fistula
* Pulp exposure
* Periodontal tissue swelling
* Abnormal tooth mobility
Effect of Anticoagulant Drug Intervention on Postoperative MALE and MACE in Patients With PAD

Patients with PAD were grouped according to the combination of different anticoagulant and antiplate drugs. The type, dosage and duration of anticoagulant and antiplatelet drugs were recorded after operation. Major Adverse Cardiovascular Events and Major Adverse Limb Events were followed up at 1 month, 6 months and 12 months, respectively.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥50 years old
2. Patients with symptomatic PAD
3. Moderate intermittent claudication, or severe limb ischemia
4. Radiographically confirmed occlusion
5. Received a successful revascularization

Exclusion Criteria:

1. Acute limb ischemia occurred within 2 weeks before revascularization;
2. Large tissue defect of any lower limb (defined as obvious ulceration/gangrene near phalangeal head);
3. After revascularization, there are clinical conditions requiring systemic anticoagulation
rhTSH, Thyroid Size, and Radioiodine Therapy in Benign Goiter

The trials in this protocol deals with the effect of pretreatment with rhTSH on radioiodine treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter. It is an introduction of a novel principle, based on prospective, randomized double blind investigations. Attached to this, we investigate the acute effects of rhTSH on thyroid size (measured by ultrasonography), both in healthy individuals and in patients with nontoxic nodular goiter. Thus, the investigations are divided into 4 categories listed below:

1. Prospective randomized double blind study of pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine in nontoxic multinodular goiter.
2. Prospective randomized double blind study of the pretreatment with 0.3 mg recombinant human TSH for the effect of radioiodine on thyroid size and function in patients with a very large (\>100 ml) nontoxic or toxic goiter.
3. Does administration of 0.9 mg recombinant human TSH affect thyroid function and volume in healthy individuals? A randomized double-blind cross-over trial.
4. Does administration of 0.3 mg recombinant human TSH affect thyroid function and volume in healthy individuals and in patients with multinodular non-toxic goiter? A randomized double-blind cross-over trial.

   As a final note we investigate, in a pilot-study;
5. The influence of rhTSH on thyroid radioiodine uptake in patients with hyperthyroidism treated with continuous block-replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with an intact thyroid gland
* Patients with nontoxic/subtoxic nodular goiter confirmed by ultrasonography
* Patients with toxic nodular goiter
* Patients with Graves' disease

Exclusion Criteria:

* Treatment with drugs that alter thyroid function or size (the last 3 months prior to inclusion)
* Prior 131I treatment
* Alcohol, medicine or drug abuse
* Pregnancy or lactation
* No safe contraception
* Participation in another clinical trial
* Allergic reaction towards rhTSH
* Fine needle biopsy without valid diagnostic criteria for benign disease
* Suspicion of malignancy, increased ionized serum calcium and/or serum calcitonin
* Incontinence
* Physically or psychic condition that hinders corporation
* Ischemic attack up till 3 months before inclusion
The Effectiveness of Physical Activity Monitoring and Distance Counseling in an Occupational Health Setting

The CoAct study is investigating a novel lifestyle intervention, aimed at the working population, with daily activity monitoring and distance counseling via telephone and secure web messages. The main purpose of this study is to evaluate the effectiveness of lifestyle counseling on the level of physical activity in an occupational health setting. The purposes include also analyzing the potential effects of changes in physical activity on productivity at work and sickness absence, and health care costs.

CoAct is a randomized controlled trial with two arms: a control group and intervention group with daily activity monitoring and distance counseling. The intervention focuses on lifestyle modification and takes 12 months. The study population consists of those volunteering from 1100 eligible employees from a Finnish insurance company. The primary outcomes are change in physical activity measured in MET hours per week, work productivity and sickness absence, and health care utilization. Secondary outcomes include various physiological measures. Cost-effectiveness analysis will also be performed. The outcomes will be measured by questionnaires at baseline, after 6, 12, and 24 months, and sickness absence will be obtained from the employer's registers.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Paid employment of at least 8 hours a week
* Not scheduled to retire in the next two years or have applied for disability pension
* Have completed a health risk appraisal and physical testing

Exclusion Criteria:

* Pregnancy
* Diagnosis or treatment of cancer
* Any disorder that makes physical activity impossible
TENS of MENS for Rotator Cuff Tear

The aim of this study was to clarify the effectiveness of physiotherapeutic intervention through the TENS or MENS in conjunction with kinesiotherapy in patients with partial thickness rotator cuff tear.

The primary characteristic of a rotator cuff tear is pain, while muscle weakness appears as a secondary feature, leading to further disability.

The aim of this study was to clarify the effectiveness of physiotherapeutic intervention through the TENS or MENS in conjunction with kinesiotherapy in patients with partial thickness rotator cuff tear.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering shoulder pain because of partial thickness rotator cuff tear, confirmed with MRI and ultrasound scanning.
* Patients not receiving any recent pharmacotherapy with NSAIDs during the last month, or surgery at the shoulder area at any time point,
* The referral orthopedic had suggested physiotherapy.

Exclusion Criteria:

* Patients with open wounds or skin diseases in the shoulder area
* pregnant women
* patients with any type of neoplastic disease
* patients with pacemakers or serious cardiovascular diseases including arrhythmia, - patients with collagen diseases
* history of shoulder surgery