cyrilzakka/clinical-trials huggingface dataset:
Radiostereometry in Knee Arthroplasty

The innovative aspect of this research is the possibility of combining the data collected with radiostereometric model based Radiostereometry with the data collected through the Galeazzi Institute Registry.This opens the prospect of an earlier identification of patients undergoing prosthetic knee replacement with initial aseptic loosening.


Eligibility Criteria:
Inclusion Criteria:

* age more than 18
* patients underwent total knee arthroplasty without controindications for this procedure
* patients enrolled in PatientsReportedOutcomesMeasureS (PROMS) study

Exclusion Criteria:

* age less than 18
* comorbility that make difficult come back for follow-up
* patients with allergy at materials used in Radiostereometry tecnique
* infection
* anemia, obesity, osteoporosis
* pregnancy
Efficacy Of Pulsed Electromagnetic Field Therapy On Neurogenic Bladder in Children With Myelomeningocele

This study was conducted to assess the efficacy of pulsed electromagnetic field therapy on neurogenic bladder in children with myelomeningocele .Intervention: A pretest-post test controlled study was conducted in out-patient clinic in faculty of physical therapy Cairo university.

Myelomeningocele is the most common cause of neurogenic bladder in children. Bladder function in these children is affected by disordered innervation of detrusor muscle and external urethral sphincter that may lead to hydronephrosis. Thirty myelomeningocele children with neurogenic bladder were enrolled in this study and were assessed for eligibility. Their aged between 4 and 12 years. They were divided randomly into two groups. Group (A) which is the control group received medical care and standard urotherapy only. And Group (B) which is the study group received medical care and standard urotherapy in addition to pulsed electromagnetic field therapy for three successful months. All children were assisted using urodynamic studies before and after three months of intervention.

Eligibility Criteria:
Inclusion Criteria:

* their age was ranging from four to twelve years.
* children participated in this study were from both sexes.
* all children with stable medical and psychological status and had the same socioeconomic status.
* they were able to follow the verbal commands or instructions.

Exclusion Criteria:

* children with visual or auditory problems.
* children with any neurological manifestation rather than spina bifida.
* medically unstable children especially with cardiovascular disorders, or mentally retarded children.
* children with any sign of urinary tract infection, or any implanted metal.
* uncooperative children.
A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency

This study will evaluate a new and safe testing method for identifying medicines that can cause problems in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. We are looking for volunteers with G6PD deficiency who would be willing to donate blood samples.


Eligibility Criteria:
Inclusion:

* Normal clinical evaluation
* Willing and able to make all scheduled visits

Exclusion:

* pregnant or planning pregnancy
* Have taken any anti-malarial medication in past month
* Positive blood tests for HIV and specific types of hepatitis
* Allergic to primaquine
Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

This is a pilot, prospective randomized controlled study with the primary objective to evaluate and compare medical treatment of severe SHPT, namely oral cinacalcet versus surgical treatment, that is, parathyroidectomy with forearm autografting, on the progression of coronary artery and valvular calcification and left ventricular mass index in endstage renal disease patients receiving peritoneal dialysis over 12 months. The change in arterial stiffening, left ventricular volume, aortic valve calcium score and bone mineral density, nutritional status and biochemical parameters, quality of life measures will be evaluated as secondary objectives of this study.

Patients with severe secondary hyperparathyroidism (SHPT) are frequently complicated with vascular calcification. There is some suggestion that subtotal parathyroidectomy may reduce or stabilize vascular calcium scores in dialysis patients. Experimental data suggests that SHPT plays an important role in mediating uraemic arterial disease and that parathyroidectomy largely prevented the development of calcification. Cinacalcet has emerged as a novel therapy for the treatment of SHPT and has been shown to reduce the need for surgical parathyroidectomy. However, their effects on vascular, cardiac, bone and nutrition status have not been evaluated and compared with parathyroidectomy.

Eligibility Criteria:
Inclusion Criteria:

1. ESRD patients on long-term peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels \> 800pg/mL.
2. Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan.
3. Patients with age between 18 - 75 years.

Exclusion Criteria:

1. Patients with background valvular heart disease
2. Patients who are unfit for general anaesthesia
3. Patients with acute myocardial infarction within recent two months
4. Patients with poor general condition
5. Patients with plans for living related kidney transplant within 1 year
6. Patients with previous history of parathyroidectomy
7. Patients with underlying malignancy
8. Patients with hepatic dysfunction
Comparison of HR011408 and NovoRapid® in Subjects With Diabetics

The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in Subjects with Diabetics.


Eligibility Criteria:
Inclusion Criteria:

- Subjects had to meet all the following criteria to enrol this study

1. Male or female aged 18-64 years (both inclusive)；
2. Body mass index 18.5-35.0 kg/m2 (both inclusive)；
3. Diagnosed with type 1 diabetes or type 2 diabetes≥ 12 months at screening；
4. HbA1c ≤9.0% by local laboratory at screening；
5. Current treatment with any basal-bolus insulin regimen or continuous subcutaneous insulin infusion(CSII) for ≥ 8 weeks. Patients with type 2 diabetes can also take metformin but require a stable metformin dose for ≥8 weeks；
6. Current total daily insulin treatment \< 1.2 U/kg/day, and total daily bolus insulin treatment ≥ 0.3 U/kg/day and \< 0.7 U/kg/day.

Exclusion Criteria:

- Subjects who meet any of the following criteria will be excluded from this study.

1. The following laboratory or ancillary abnormalities were present from screening until randomization:

1) Poor blood pressure control, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.

2. Subject has any history or evidence meet the following diseases or conditions:

1. have had severe hypoglycaemia episodes within 6 months before screening as judged by the investigator.
2. Have hospitalization due to diabetic ketoacidosis or hyperglycaemic hyperosmolar state within 6 months prior to screening;
3. Proliferative retinopathy, maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.

3. Previous and anticipated concomitant treatments:

1. Not able or willing to refrain from any use of herbal products and non-routine vitamins within 14 days or within 5 half-lives (whichever is longer), and routine vitamins within 48 hours prior to trial product administration
2. Within 1 month or have within 5 half-lives (whichever is longer) participated in any trail (defined participate in trail as having had randomized) of using investigational drug or therapy prior to screening.

4. General information:

1. Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent nicotine per day).
2. Previous participation in this study. Participation was defined as randomised.

5. Any other situation judged by investigator that may endanger the safety of the subjects or influence the evaluation of the results.
Effect of tDCS on Chronic Abdominal Visceral Pain in HCC Patients

To evaluate the effect of transcranial direct current stimulation (tDCS) applied to the motor cortex to reduce chronic abdominal visceral pain in a group of participants with hepatocellular carcinoma

This study will be carried out in Assiut University Hospital pain clinic and in participation of department of neuropsychiatry in Assiut University Hospital. After obtaining approval of hospital ethical committee, informed written consent will be taken from all patients with malignant visceral pain to be involved in this study.

In these study investigators test the hypothesis that Does transcranial direct current stimulation induce analgesia in chronic abdominal visceral pain due to liver cancer ?

Preparation:

The patient will seat in a comfortable chair and will be asked to relax as much as possible. tDCS was delivered using a battery driven DC stimulator (neuroConn Gmbh,98693 llmenau, Germany). Current was delivered by electrodes encased in sponge pads soaked with 1% saline solution. The machine was kept behind the participant and out of their view at all times. For both the active and sham conditions, the anode was placed over the motor cortex of the patient and the cathode was placed over the contralateral supraorbital region. Electrodes were secured using soft elastic straps.

In the active stimulation condition a constant current of 2mA intensity was applied for 30 minutes with a 5-second ramp phase at the beginning. In the sham stimulation condition the machine was activated for 30 seconds using identical parameters but was then switched off without the patient's knowledge. This sham control is commonly employed because over the initial 30 seconds of stimulation, an initial sensation of tingling under the electrode fades away. Patients are less likely to distinguish active from sham conditions if the initial period of tingling is present in both.

Patients were evaluated by verbal descriptor scale (VDS), visual analog scale (VAS), and Hamilton rating scale for depression (HAM-D) at the baseline, after 1st, 5th, 10th session, and 1 month after end of sessions.

Eligibility Criteria:
Inclusion Criteria:

* All patients of above 18 years old, with malignant visceral pain due to primary liver cancer or on top of cirrhosis, resistant to medical treatment for at least 2 months or associated with significant adverse effect from medication will be involved in this study

Exclusion Criteria:

* Investigators will exclude patients with intracranial metallic devices or with pacemakers or any other device. Investigators also exclude those with extensive myocardial ischemia and those known to have epilepsy.
Microwaves Ablation of Varicose Veins

Lower-limb varicose veins (VVs) are the most common of vascular diseases and affect up to one-third of the population, severely affecting the quality of life (QoL) of patients. In past decades, traditional surgical ligation and stripping were the gold standard therapy for patients with VVs; however, traditional methods have demonstrated high complication and recurrence rates. Thus, the practices are moving toward minimally invasive alternatives.

Lower-limb varicose veins (VVs) are the most common of vascular diseases and affect up to one-third of the population, severely affecting the quality of life (QoL) of patients. In past decades, traditional surgical ligation and stripping were the gold standard therapy for patients with VVs; however, traditional methods have demonstrated high complication and recurrence rates. Thus, the practices are moving toward minimally invasive alternatives. Endo venous thermal ablation, such as radiofrequency ablation and endo venous laser ablation (EVLA), has become the recommended first-line treatment for VVs worldwide. These endo venous procedures provide a quicker recovery time and improved QoL and produce fewer complications than traditional surgery .Endo venous microwaves ablation is a minimally invasive procedure in treatment of V.V, investigators confirmed that endo venous microwave ablation (EMA) was an effective new technique for the treatment of VVs. On previous trials confirmed that the endo venous microwave ablation procedure demonstrated a shorter procedure time, lower complication, and local recurrence than the endo venous laser ablation procedure. The aim of the study was to determine whether endo venous microwave ablation of varicose vein was associated with better effectiveness and less complications and evaluate the outcome of patients who underwent endo venous microwave ablation (EMA).

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 60 years, either sex, elective admission
2. primary symptomatic VVS (CEAP,C3-C6)
3. Recurrent Varicose Veins after surgery
4. Greater saphenous vein diameter up to 3 cm
5. Greater saphenous vein with variable depth even with depth less than 6mm
6. Greater saphenous vein with tortuosity
7. Diabetic patient with risk of wound infection after surgery
8. Patient with hostile groin
9. Availability of patients for all follow-up visits

Exclusion Criteria:

1. secondary Varicose Veins
2. Acute thrombosis near the Saphenous-femoral junction
3. Recanalized Greater saphenous vein
4. pregnancy
Atrial Fibrillation Ablation Registry

The Atrial Fibrillation Ablation Registry (AFib Ablation Registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous catheter ablation procedures to treat atrial fibrillation (AF).

The Atrial Fibrillation Ablation Registry (AFib Ablation Registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous catheter ablation procedures to treat atrial fibrillation (AF). Patient-level data will be submitted by participating hospitals on a quarterly basis to the American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR™). The primary aims of the AFib Ablation Registry are to optimize the outcomes and management of patients through the implementation of evidence-based guideline recommendations in clinical practice, facilitate efforts to improve the quality and safety for patients undergoing percutaneous catheter ablation procedures, investigate novel quality improvement methods and provide risk-adjusted assessment of patients for comparison with nationwide NCDR data. The secondary purpose of the AFib Ablation Registry is to serve as a rich source of clinical data to support assessments of short- and long-term safety, comparative and cost effectiveness research, and as a scalable data infrastructure for post market studies.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients
2. 18 years and older
3. Undergoing percutaneous catheter ablation procedures to treat atrial fibrillation

Exclusion Criteria:

1. none
Investigation of the Added Value of a Big Toe Hinged Brace for the Treatment of Hallux Rigidus

Comparison of the added value of a rehabilitation brace to standard rehabilitation by physiotherapy


Eligibility Criteria:
Inclusion Criteria:

* Hallux rigidus

Exclusion Criteria:

-
Regulatory Network and Diagnostic Value of Key Autophagy-related Genes in Sepsis

Autophagy plays an important role in the occurrence and development of sepsis. This study aims to explore and verify the key autophagy-related genes in sepsis, then construct their regulatory networks and evaluate their potential diagnostic value, so as to provide new ideas for the diagnosis and treatment of sepsis.

(1) Sepsis-related datasets GSE65682,GSE134347 and GSE134358 were downloaded from GEO database, and DEmRNA,DElncRNA and DEmiRNA were obtained by differential analysis. (2) Autophagy related genes (ARGs) were obtained from Human Autophagy Database, and ARGs in GSE65682 and GSE134347 were extracted. DEARGs were obtained by differential analysis, and GO and KEGG enrichment analysis were performed. (3) Sepsis-related genes were obtained by WGCNA analysis, and key DEARGs in sepsis were obtained by intersection with DEARGs, and then transcription factors and ceRNA regulatory network were analyzed. (4) Immune infiltration analysis was used to evaluate the distribution of immune cells in the blood of patients with sepsis, and its correlation with key DEARGs was further analyzed. (5) The diagnostic functions of key DEARGs were analyzed. (6) Peripheral blood samples from sepsis patients and healthy controls were collected and verified by RT-qPCR.

Eligibility Criteria:
Inclusion Criteria:1) over 18 years old; 2) Meeting the diagnostic criteria of Sepsis 3.0; 3) Hospital stay longer than 24 hours.

Exclusion Criteria:1) Malignant tumor; 2) Autoimmune diseases; 3) Use of immunosuppressants in the past two weeks; 4) Readmission or transfer from another ICU due to the same disease.
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment

To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic function


Eligibility Criteria:
Inclusion Criteria:

All subjects

* Able to provide written informed consent to participate in this study after reading the ICF
* Subjects is able to understand and willing to cooperate and comply with the Protocol restrictions and requirements.
* A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging from 18 to 30 kg/m2

Hepatic impaired subjects (in addition)

* A Child-Pugh score of 5 or 6 for subjects with mild hepatic impairment, and between 7 and 9, inclusive, for subjects with moderate hepatic impairment
* Chronic and stable hepatic impairment

Healthy subjects (in addition)

* Subject with normal hepatic function
* Good health and free from clinically significant illness or disease

Exclusion Criteria:

All subjects

* Presence or history of severe allergy to food, or any medicinal product or relevant excipient that is of clinical significance
* Subjects were previously administered MCI-186.
* Positive urine drug screen (if not due to concomitant medication) or alcohol test
* History of drug abuse
* Presence of alcohol abuse
* Presence of active infection requiring antibiotics
* Positive test for human immunodeficiency virus (HIV) antigen/antibody
* Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)\>160 mmHg and/or diastolic blood pressure (DBP)\>100 mmHg
* eGFR \<60 mL/min/1.73m2

Hepatic impairment subject (in addition)

* Subjects with severe ascites

Healthy subject (in addition)

* History or presence of any parenchymal hepatic disease
* Positive test for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCVAb)
Efficacy and Safety of Tegoprazan Dual Therapy and Furazolidone-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study

To compare the efficacy and safety of Tegoprazan-amoxicillin dual therapy and bismuth quadruple therapy based on furazolidone in the treatment of Helicobacter pylori eradication, the eradication rate, patient compliance, and adverse drug reactions of H. pylori infection were compared in a multi-center clinical joint study in Jiangsu Province.

This study is a prospective, multicenter, open-label, randomized, parallel-controlled study. A total of 600 Hp-positive patients who had not received Hp eradication therapy before or who had previously eradicated Hp but had not undergone eradication therapy in the past six months were recruited, and the basic clinical data of the patients (age, gender, drug allergy history, diagnosis and treatment, etc.) were recorded, and they were randomly divided into two groups according to the ratio of 1:1. Group A subjects received oral Tegoprazan 50mg, bid + amoxicillin 1000mg, tid; Group B subjects received oral Tegoprazan 50 mg, bid + amoxicillin 1000 mg, bid + furazolidone 100 mg, bid + colloidal pectin bismuth 300 mg, bid. The duration of treatment is 14 days.

During the 14-day eradication treatment period, all participants were asked to record their adverse reactions and adherence to the medication. On the 7th and 14th days of medication, the researchers will conduct follow-up visits through WeChat or telephone to determine the adverse reactions and compliance of the patients, and observe and record whether the subjects have nausea, diarrhea, dizziness, bitter mouth, rash, constipation and other adverse reactions. In addition, subjects returned to the hospital 4-6 weeks after the end of treatment to check for H. pylori eradication by 13C-UBT or 14C-UBT.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old;
2. Patients who have had a positive 13C or 14C breath test and have not received Helicobacter pylori eradication therapy before, or who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
3. Voluntarily join this trial and sign the informed consent form.

Exclusion Criteria:

1. Allergy to the study drug (penicillin, amoxicillin, furazolidone, Tegoprazan, etc.);
2. Patients with active peptic ulcer disease;
3. Patients who have received Helicobacter pylori eradication therapy within half a year;
4. Use of antibiotics, bismuth, histamine H2 receptor antagonists or PPIs for 4 weeks before starting study treatment;
5. use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs or anticoagulants;
6. History of esophageal or gastric surgery;
7. Pregnant or lactating women;
8. Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
9. Alcoholism.
10. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.
Advanced Cardiovascular Imaging of the Systemic Effects of Inflammasome Activation

Subjects with urgently reperfused type I myocardial infarction (MI) will be recruited and randomized to receive either placebo or the oral inflammasome (NLRP3) inhibitor dapansutrile. The primarily outcome measure will be carotid plaque volume change over 6 months; secondary outcome measures will be plaque inflammatory activity and coronary microvascular function.


Eligibility Criteria:
Inclusion Criteria:

* Acute type I myocardial infarction (NSTEMI or STEMI)
* Reperfusion therapy planned or performed within prior 48 hrs
* Carotid or femoral artery plaque at baseline, or carotid intima media thickness \>1.5 mm

Exclusion Criteria:

* Type II MI
* Failed primary PCI or need for emergent bypass surgery
* Severe heart failure (NYHA class IV)
* Life-threatening complication of MI (myocardial rupture, ischemic VSD, papillary muscle rupture)
* Refractory ventricular arrhythmias
* Allergy to dapansutril, OLT177, or drugs in the same class
* Co-morbidity limiting 6 month survival
* Active malignancy or recent malignancy with any systemic anti-cancer treatment
* Active infection
* Use of immunosuppressive medications or immunodeficiency disorder
* Neutropenia (ANC \<2,000)
* Moderate or severe renal impairment (GFR \<30 ml/min)
* Recent stroke (within previous 3 months)
* Allergy to ultrasound enhancing agents or polyethylene glycol
* Pregnancy or breastfeeding