cyrilzakka/clinical-trials huggingface dataset:
Expression Levels of Nicotinamide Metabolism-related Protein (NMAP) in Newly Diagnosed Renal Cancer and Non-renal Cancer Populations

This study aims to observe the difference between NMAP (nicotinamide metabolism associated protein) serum levels in primary diagnosed renal cancer patients and non-renal cancer patient controls, plot the ROC curve and establish appropriate cut-off values.


Eligibility Criteria:
Inclusion Criteria:

1. The tumor group patients were found to have renal or hepatic mass, plan to receive surgical treatment (except for radiofrequency ablation, cryoablation, etc., which were not available for pathological examination). The control group patients were ruled out of tumor based on radiological tests and commonly used tumor biomarkers
2. Age ≥ 18 years old and able to provide written informed consent;
3. Have not received any systemic or topical treatment for kidney/liver tumors.
4. Cardiopulmonary, liver and kidney functions are able to tolerate surgery and can comply with research requirements.

Exclusion Criteria:

1. The investigators believe that the subject may be unsuitable for inclusion due to severe concurrent diseases, infections, and etc.
2. The subjects is known or suspected of other malignancies.
3. There has been another history of malignancy in the past 5 years.
4. Major surgery (surgery requiring general anesthesia) was performed within 4 weeks prior to screening visits.
Quality Control of CE-Certified Phonak Hearing Aids - 2019_19

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

In this study one CE-labeled Phonak Behind-the-ear (BTE) devices is investigated including CE-labeled compatible accessories. The experimental device will be investigated regarding its performance of speech understanding in noise with and without an accessory existing of an external microphone to pick sound at a certain target. A secondary objective of this study is the investigation of the Overall system stability in daily life situations. The experimental device contains direct connectivity functionality. Another objective of this study is the investigation of the subjective occlusion effect of different acoustic couplings. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility Criteria:
Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss) without hearing aid experience
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature
* owning a compatible smartphone
* Hearing loss in range of N2-N3 (ISO 60118-15)

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Known psychological problems
* Central hearing disorders
Telerehabilitation After Total Knee Arthroplasty

The aim of this study was to assess the function, pain intensity and walking distance in patients prior to and after total knee arthroplasty, who received therapy either in a clinic under direct supervision of a physical therapist and patients who received telerehabilitation.

The study population consisted of 105 patients who had knee arthroplasty due to knee arthrosis followed by 6- weeks physiotherapy, mean age 68.5 ± 7.3 years. The patients were randomly divided into two groups: I - telerehabilitation group (n=54), and II clinical control group (n=51), who received physiotherapy supervised by physiotherapist. All patients were given the following tests: VAS (0-10), 6-Minute Walk Test, and KSS - Knee Society Score.

Eligibility Criteria:
Inclusion Criteria:

* total cemented knee arthroplasty with posterior stability (PS -cruciate sacrificing, posterior stabilized),
* informed consent to participate in the study,
* full medical record,
* patients' regular control visits,
* knee degenerative disorder stage II and III according to Altman classification,
* ability to understand and independently perform the complete physiotherapeutic programme

Exclusion Criteria:

* partial arthroplasty,
* deformation aetiology other knee degenerative disorder,
* cognitive disorders resulting in inability to fill out the study questionnaire, - degenerative disorders of multiple joints,
* poor general health that prevented the patient from understanding or performing the full physiotherapeutic programme,
* intraoperative and postoperative complications preventing the patient from understanding or performing the full physiotherapeutic programme,
* lack of informed consent to participate in the study.
A Comparison of US and Evoked Motor Response-guided Placement of Continuous Femoral Nerve Block Following TKA

The purpose of this study is to determine which technique for catheter placement in continuous femoral nerve block (FNB) is most successful - guidance with (1) ultrasound or (2) nerve stimulation and ultrasound. Sensory and motor assessment scores will be obtained post-FNB. Patient controlled analgesia and opiate consumption is also recorded along with pain scores for the first 48 hour post-FNB.

Continuous femoral nerve block (cFNB) is a widely used regional anesthetic technique for many lower limb operations, such as total knee arthroplasty (TKA), anterior cruciate ligament repair, tibial osteotomy and patellar surgery. It provides superior pain relief, faster ambulation, shorter hospital stays and less risk of side effects in comparison to patient controlled analgesia (PCA), local anesthetic wound infiltration, or single shot femoral nerve block (FNB).

Stimulating catheters were introduced in 1999 to provide an objective end point to guide continuous nerve block catheter position by maintaining the desired evoked muscle response with nerve stimulation (NS). The main advantages of stimulating catheters are faster onset of sensory and motor block and reduction of local anesthetic drugs consumption. In recent years the precise insertion of continuous catheters has improved especially with the introduction of ultrasound (US)-guided imaging to regional anesthesia practice and advances in scanning techniques. That led to a call to reduce cost by switching to non-stimulating catheters. However, most studies comparing both catheters lacked anesthetic technique standardization and adequate sample size.

In this prospective randomized controlled trial, we compared postoperative analgesic efficacy and opioids consumption in patients having cFNB insertion using US alone and that of US combined with NS.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I to III patients
* Aged 18-75 scheduled for unilateral TKA

Exclusion Criteria:

* History of significant psychiatric problems
* BMI \> 40 kg/m\^2
* Prior surgery in the inguinal region
* Neurological disease with sensory or motor deficit
* Diabetic neuropathy
* Contraindication to any study medications
* Daily opioid consumption \>10 mg PO morphine (or equivalent) for 2 weeks prior to surgery
Decisional Regret in Open Partial Horizontal Laryngectomy

Prospective multicentric study to evaluate decisional regret and psychometric and functional outcomes in patient previously treated with Open Horizontal partial Laryngectomy


Eligibility Criteria:
Inclusion Criteria:

* SCC larynx treated with OPEN PARTIAL HORIZONTAL LARYNGECTOMY

Exclusion Criteria:

* Previous surgical treatment of the larynx
* Previous CT-RT of the head and neck district
Stenting of Renal Artery Stenosis in Coronary Artery Disease Study

The Stenting of Renal Artery Stenosis in Coronary Artery Disease (RASCAD) study is a randomized controlled trial designed to evaluate the effect of renal artery stenting+medical therapy versus medical therapy alone on left ventricular mass progression and cardiovascular morbidity and mortality in patients affected by coronary artery disease and renal artery stenosis.

Patients with renal artery stenosis (RAS) have high frequency of alterations of left ventricular mass and function. Whether renal revascularization can improve cardiac function and structure in patients with RAS is not known.

The Stenting of Renal Artery Stenosis in Coronary Artery Disease (RASCAD) study was planned to test whether renal artery revascularization, compared with medical therapy, affects left ventricular hypertrophy progression and clinical outcomes in a high-risk population such as patients with evidence of coronary artery disease and RAS.

Incidental patients affected by ischemic heart disease,undergoing cardiac catheterization at a single institution, are also evaluated for the presence of RAS by renal angiography at the end of coronarography. Patients with RAS \>50% and ≤80% are randomly assigned to stenting angioplasty plus medical therapy (angioplasty group) or to medical therapy alone (drug therapy group)and followed up. Patients, randomly assigned to the angioplasty group, are revascularized by stenting. All randomized patients receive antihypertensive, statin or antiplatelet drugs according to clinical indications. The planned duration of follow-up is 5 years.

The health profile of patients is described in full at study entry. Cardiovascular events (AMI, re-PTCA, cardiac heart failure, stroke,peripheral vascular disease),death, hospitalizations and medications are carefully registered throughout the study.

Standard echocardiography and renal ultrasound studies are performed at baseline and repeated every year. Echocardiography is performed following American Society of Echocardiography guidelines. LV mass is estimated using the Devereux formula and indexed to body surface area.

Eligibility Criteria:
Inclusion Criteria:

* ischemic heart disease
* angiographic diagnosis of atherosclerotic RAS \>50% and ≤80%

Exclusion Criteria:

* Atherosclerotic RAS\>80%
* RAS secondary to fibromuscular dysplasia
* AMI
* single functioning kidney and/or sCr \>4 mg/dl
* severe aortic valve stenosis
* aortic aneurism necessitating surgery
Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)

The purpose of this study was to evaluate the efficacy and safety of different doses of pramipexole (Sifrol) on subjective and objective symptoms of idiopathic Restless Legs Syndrome (RLS) and also to determine the optimal dose of pramipexole in patients with RLS by polysomnography and evaluation of clinical improvement.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female 18-80 years
2. Confident diagnosis of RLS according to International RLS Study Group criteria
3. RLS rating scale for severity score \>15
4. PLM (during time in bed ) index at least 5 per hour
5. Weekly presence of RLS symptoms within last three months
6. Written Informed consent

Exclusion Criteria:

1. Women of childbearing potential, who do not use adequate protection such as barrier protection, intrauterine device, or hormonal (oral or subcutaneous) contraception
2. Postmenopausal women less than 6 months after last menses, surgically sterilised, oophorectomised or hysterectomised less than 3 months after operation and not using adequate protection
3. Women neither using adequate protection nor being postmenopausal and their partner is not sterilised at least 6 months post operation or does not use condom
4. Any women not having negative serum pregnancy test at screening
Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory

In order to more accurately discover the cause of drug resistance in tumor treatment, and to provide a new basis for precise treatment.

Therefore, based on the umbrella theory of precision medicine, we carried out this single-center, prospective, and observational study to include patients with liver metastases from colorectal cancer. By combining genome, transcriptome, and proteomic sequencing data, we established a basis for colorectal cancer liver Transfer the multi-omics data of the sample, describe the reason for the resistance of the first-line treatment, and search for new therapeutic targets.


Eligibility Criteria:
Inclusion Criteria:

* ECOG score 0-2 points
* Pathologically diagnosed patients with colorectal cancer
* Combined with liver metastases confirmed by imaging, and the lesion is measurable (RECIST standard)
* The lesion is available
* First-line treatment failed; hematology, liver and kidney function tests are suitable for back-line treatment
* Informed consent

Exclusion Criteria:

* With brain metastases
* History of other malignancies
* Pregnancy or breastfeeding
* Have received other drug clinical studies within 30 days before the start of this study
Laryngomalacia Exposed

Laryngomalacia is the most common congenital laryngeal anomaly and the most frequent cause of stridor in infants and children. Symptoms usually appear within the first 2 weeks of life. Its severity increases up to 6 months. 15-60% of infants with laryngomalacia have synchronous airway anomalies.

The most common health complications associated with laryngomalacia were: 1. Gastroesophageal reflux which was presented by arching, choking, gagging, feeding aversion and continuous crying 2. Frequent unilateral eye infections 3. Repeated choking, frequent vomiting and poor weight gain 4. Repeated upper respiratory tract infections (viral and bacterial), coughing and cyanosis 5. Repeated secretory otitis media 6. Aspiration pneumonia

Eligibility Criteria:
Inclusion Criteria:

* 500 full term babies ≥ 37 weeks of both sexes were delivered by different modes of delivery, with birth weights of ≥ 2.5 kg, with no history of natal complications and from the same community.
* Mothers of these babies are from different socioeconomic standards with different educational levels.
Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* History T2DM
* Moderate or Severe Renal Impairment

Exclusion Criteria:

* Glucose \> 270 mg/dL (\>15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply.
Trauma Registry in Villavicencio, Colombia

Introduction: Injuries are a leading cause of mortality worldwide. It is necessary to know the incidence of injuries, mechanisms of wounds, therapy provided, and outcomes. Trauma registries are useful to describe the population served in specialized centers. Nevertheless, it is necessary also to identify the peculiarities of the event in the province and institutions non-dedicated to trauma attention.

Objective: The study aims to describe the initial experience with a trauma register in a general hospital in the Colombian Orinoquia.

Methodology: The investigators designed an observational retrospective study to analyze the admission database and revision of history charts of patients older than 15 years admitted for trauma from January to June 2023 in a hospital from Villavicencio, Colombia. The information will be exported to Excel for debugging and analysis. A description of the frequency and proportion of categorical variables will be performed; the central distribution and dispersion of quantitative variables will be reported. U of Mann-Whitney and Chi-square tests will be used to compare the variables by outcome; a p\<0.05 was selected as a significant value.

Conclusions: It will be a pioneer study in this region, and it is necessary to evaluate the incidence of patients admitted by trauma, the mechanisms and type of injury, the care provided, and the outcomes.

Trauma is a leading cause of global mortality or incapacitation in survivors. The population involved is mainly young adult men affected by preventable injuries. Knowing the incidence of injuries, mechanisms of wounds, approaching strategies, and outcomes is essential to review individual interventions and collective policies to improve prevention.

Casualties in Colombia had a high incidence in previous decades; injuries and attributable deaths have recently decreased, but they are still the third cause of mortality. Contrary to high-income countries, interpersonal violence is the predominant mechanism involved.

Data registries are used worldwide in specialized centers that focus on providing healthcare in trauma. Nevertheless, it is necessary also to know the incidence in community and non-dedicated general hospitals.

Determining the characteristics of patients admitted to the emergency ward by injuries will provide essential information on the severity, mechanisms, type of population affected, immediate or consequential care delivered, and outcomes. Such an analysis will give knowledge to prioritize policies, resources, upgrade clinical practice guidelines, and improve results.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the emergency ward by trauma.

Exclusion Criteria:

* None.
Evaluation of Modified Minimally Invasive Surgical Technique and Platelet Rich Fibrin With or Without Vitamin Pool A and C for Management of Periodontal Intrabony Defects

This study aims to assess clinical and radiographic outcomes after the use of vitamins A and C with PRF versus PRF alone in the treatment of periodontal intrabony defect.

Sites with deep intrabony defects were considered to be at a higher risk of disease progression if patients did not receive any systematic periodontal therapy. Treatment of intrabony defects is an important therapeutic goal of periodontal therapy. The optimal outcome of treatment in intrabony defects is considered to be the absence of bleeding on probing, the presence of shallow pockets associated with periodontal regeneration and limited soft tissue recession.The minimally invasive surgical technique is designed to mobilize just the defect-associated papilla and to reduce flap extension as much as possible. The modified minimally invasive surgical technique has been proposed to further reduce invasiveness and patient side effects by limiting the incision line to the buccal side. This technique fulfilled the maintenance of the interdental papillary height by minimizing its tendency to collapse, increased the likelihood of primary wound closure and reduced the chances of gingival recession.

Platelet-rich fibrin is a powerful healing biomaterial with inherent regenerative capacity and can be used in the treatment of periodontal intrabony defects.

Vitamin C is found to be able to induce osteogenic differentiation and maturation of progenitor cells of PDL without using osteogenic filling material. Also, Vitamin A has a unique property of de-differentiating adult cells into pluripotent cells.

Since combination therapies have been shown to be effective in the regeneration of periodontal defects, this study will evaluate the synergetic effect of vitamins A and C on the periodontal regeneration, together with the most widely used regenerative biomaterial; Platelet-rich fibrin, as an attempt for finding the gold standard in the treatment of intra-bony defects.

Eligibility Criteria:
Inclusion Criteria:

* Patient-related criteria:

  * Patient consulting in the outpatient clinic with periodontitis stage III
  * Able to tolerate surgical periodontal procedures.
  * Patient ready to perform oral hygiene instructions.
  * Compliance with the maintenance program.
  * Provide informed consent.
  * Accepts the 6 months follow-up period.

Teeth related criteria:

* Mature permanent tooth.
* Tooth with two or three-walled intra-bony defect, with CAL ≥ 5mm and intra osseous defect ≥ 3mm.

Exclusion Criteria:

* Patient-related criteria:

  * Medically compromised patients.
  * Pregnant or nursing women.
  * Uncooperative patients.
  * Smokers.

Teeth related criteria:

* Teeth with one wall intra-bony defect.
* Teeth with supra-bony defects.
* Teeth with grade III mobility.
Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block

This study is a multicenter, prospective, randomized study to assess if cardiac dysfunction patients with LVEF \<50% and the estimated ventricular pacing percentage \>40% with LBBP have the non-inferior safety and efficacy than CRT on patients' cardiac function and prognosis

Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, patients with cardiac dysfunction who met the enrollment criteria and will agree to participate in this trial will be 1:1 randomized to the LBBP group and the CRT group. Patients who were successfully implanted were enrolled for evaluation and follow-up. The primary end points of the study is the change of LVEF within 12 months post-implant in both LBBP Treatment Group and CRT Treatment Group

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* Agree to participate in trial and sign informed consent
* NYHA cardiac function class I-III
* LVEF\<50%
* Second or complete atrioventricular block with pacing indication or ventricular pacing dependent with ventricular pacing percentage \>40%
* Patients who are willing to take the de-novo implant or device replacement or upgrade.

Exclusion Criteria:

* Life expectancy \<1 year
* Patients with severe tricuspid valvular disease1 or who have undergone mechanical valve or bioprosthetic valve surgery
* Acute myocardial infarction within 1 month
* Women of childbearing age who are pregnant or becoming pregnant during the study period
* Severe liver and kidney dysfunction2
* Have been enrolled in another clinical studies that may interferes with the current trial objectives
* Evidence of severe pulmonary hypertension (PASP\>70mmHg)
* Evidence of hypertrophic cardiomyopathy which shall affect the prognosis of patients.
* The investigator believes that subject's physical condition is not suitable for participation in the trial