cyrilzakka/clinical-trials huggingface dataset:
Comparison of ESP Block and M-TAPA Block Efficiency in Postoperative Analgesia Management in Nephrectomy Cases

Relieving postoperative nephrectomy pain requires multimodal approaches. Peripheral blocks such as ESP block and M-TAPA block and multimodal analgesics reduce side effects by reducing the use of other analgesics. This study aimed to compare the effectiveness of erector spinae plane block (ESP block) and modified thoracoabdominal nerve blocking with perichondrial approach (M-TAPA block) in postoperative analgesia management in nephrectomy cases.

Relieving postoperative nephrectomy pain requires multimodal approaches. The most commonly used in the treatment of pain are nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and infiltration of local anesthetics. Due to the side effects of NSAIDs and opioids, the application of regional analgesia techniques can reduce complications while providing better analgesia quality. Peripheral blocks such as ESP block and M-TAPA block and multimodal analgesics reduce side effects by reducing the use of other analgesics. Pain is considered one of the most important factors affecting the quality of healing. Postoperative pain delays the postanesthesia care unit, hospital stay, early ambulation, increases resource utilization, and negatively affects patient satisfaction. If postoperative analgesia is provided, all these negativities will be eliminated. This study aimed to compare the effectiveness of erector spinae plane block (ESP block) and modified thoracoabdominal nerve blocking with perichondrial approach (M-TAPA block) in postoperative analgesia management in nephrectomy cases.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 and over with ASA1-2 who underwent elective nephrectomy

Exclusion Criteria:

* ASA ≥3
* Body mass index\>35 kg/ m²
* Infection in the block area
* Coagulation disorder,
* Known allergy to local anesthetics
* Pregnant
* Patient with neuropathy
* Patient without cooperation
* Patient who refuses to participate in the study
* Patients under 18 years of age
Study of Ischemic Colitis Compared to Other Diagnoses in Patients With Lower Gastrointestinal Bleeding

The purpose of this study is to study the demographic,laboratory,endoscopic, and outcomes of ischemic colitis patient presented with severe lower gastrointestinal bleeding compared to other diagnoses.

Secondary purpose of this study is to assess the risk factors for predicting diverticulosis versus ischemic colitis.

Eligibility Criteria:
Inclusion Criteria:

* bright red blood clots or burgundy colored stool documented by a health care worker
* clinical or laboratory evidence of significant blood loss, manifested by any one of the following: (a) more than three bloody bowel movements in eight hours (b) a decrease of two grams of hemoglobin (Hgb) from baseline, or (c) transfusion of more than three units of red blood cell (URBC).

Exclusion Criteria:

* age less than 18 year
* history of inflammatory bowel disease
* hypotension or shock refractory to resuscitation
* severe coagulopathy refractory to resuscitation (platelet count \< 30,000; prothrombin time \[PT\]- more than 2 times normal; partial thromboplastin time \[PTT\]- more than 2 times normal)
* acquired immune deficiency syndrome or neutropenia
* the inability to provide informed consent
* documentation of anal disorders as a cause of bleeding such as internal hemorrhoids, anal fissures, polyps or cancer of the anal canal, and fistulae
Trial to Evaluate Safety and Tolerability of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C)

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-PCS02 in subjects with Elevated LDL-Cholesterol (LDL-C).


Eligibility Criteria:
Inclusion Criteria:

* Elevated LDL-C of \>3.0 mmol/L and \<5.7 mmol/L
* Fasting triglyceride concentration ≤2.8 mmol/L
* Body weight \>60.0 kg; body mass index (BMI) between 19.00 kg/m2 and \<35.00 kg/m2
* Adequate blood counts, liver and renal function
* May not received any lipid lowering drug/agent within the 30 days prior to the screening
* Non-smokers for at least 3 months
* Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must use an adequate method of birth control
* Males agree to use appropriate contraception
* Willing and able to comply with protocol-required visit schedule and visit requirements and provide written informed consent

Exclusion Criteria:

* Known hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection
* Multiple drug allergies or know sensitivity to oligonucleotide
* History of drug abuse and/or alcohol abuse
* Receiving an investigational agent within 3 months prior to study drug administration
* Subjects with safety laboratory test results deemed clinical significant by the Investigator;
* Received prescription drugs within 4 weeks of first dosing
* Subjects who have donated more than 500 mL of blood within the 3 months prior to ALN-PCS02 or placebo administration;
* Received megadose vitamin therapy or dietary supplements within 4 weeks prior to screening
* Subjects who have used prescription drugs within 4 weeks of first dosing
* Considered unfit for the study by the Principal Investigator
* Employee or family member of the sponsor or the clinical study site personnel
Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai

The prognostic implication of left atrial appendage occlusion (LAAO) procedure in non-valvular atrial fibrillation (NVAF) patients from China is still unclear. We aim to investigate the impact of LAAO procedure on subsequent clinical outcomes in patients from China.

Although the left atrial appendage occlusion (LAAO) procedure has increasingly been performed to prevent the occurrence of ischemic stroke events among patients with non-valvular atrial fibrillation (NVAF), the clinical benefits and prognostic implications of which have not been well characterized in patients from China. As a result, we aim to conduct an observational study to explore the prognostic impact of LAAO in patient with NVAF who are hospitalized in Shanghai Tenth People's Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were admitted for NVAF undergoing LAAO procedure between January 2014 and December 2017 in the Cardiology Department of Shanghai Tenth People's Hospital;
* Adult patients (\>18 years old).

Exclusion Criteria:

* Patients with rheumatic valvular disease;
* Patients with sick sinus syndrome;
* Patients who had a history of cardiac surgery (i.e., CABG);
* patients who had received the catheter radiofrequency ablation procedure.
A Study of the Telerehabiliation Intervention Effect of the Tai Chi Exercise on Elderly With Sarcopenia

Sarcopenia is an age-related disease characterized by a progressive decrease in skeletal muscle content and loss of muscle function. Tai Chi exercises have been shown to improve skeletal muscle mass in elderly people suffering from sarcopenia. However, offline interventions are a very labor- and financial-intensive approach. Therefore, researchers designed an artificial intelligence-assisted program and Tai Chi exercise format to investigate whether a remote rehabilitation approach could replace face-to-face interventions


Eligibility Criteria:
Inclusion Criteria:

(1) Patients between the ages of 60-75 years; (2) who meet the screening criteria for sarcopenia in Asia established by AWGS 2019; (3) who have a computer at home (4) who can use a computer or was accompanied by family number who can use a computer.

Exclusion Criteria:

(1) participants taking medications that significantly impact musculoskeletal function (2) participants suffering from respiratory failure or other bodily problems; (3) participants with mental disorders or neurological disorders; (4) patients who participate in other training programs on a regular basis.
Surgical Intervention for the Treatment of Diabetes in Overweight Non-responders-1

The SIT-DOWN study is a single centered retrospective study in which a total of 90 (ninety) participants who are overweight (BMI: 25-29.9 kg/m2) and have type 2 diabetes mellitus (T2DM) will be evaluated for the efficacy of surgical intervention in comparison with medical treatment. Primary endpoint of the study will be the change in glycemic regulation by the end of 12 months.

Use of bariatric/metabolic surgery has conventionally been reserved for those whose body-mass index (BMI) is 35 kg/m2 or greater. Trials in these morbidly obese patients confirmed the benefits in terms of weight loss and provide evidence that surgery can result in remission of diabetes, and as a result lead to improvement in cardiovascular risk factors. Within the light of these data, there appear to be a shift towards lower BMI, with many advocating it as a reasonable option for diabetics with a lower BMI (\<30) who have failed other attempts of medical treatment. But this approach is limited because of lack of data on the effects of surgical outcomes in this group of patients which is the main rationale for this retrospective study.

Eligibility Criteria:
Inclusion Criteria:

* Overweight, type 2 diabetic: Type 2 diabetes diagnosis longer than 3 years; BMI= 25-29.9 kg/m2
* Participants with baseline HbA1c ≥ % 7.5, not achieved HbA1c \< % 7.3 at 3 months on therapy
* Absence of co-morbidities (neuropathy, retinopathy, cardiovascular disease, stroke events or lower extremity amputation).

Exclusion Criteria:

* Liver cirrhosis, severe renal failure, collagen diseases, severe endocrinopathies, blindness.
* Heart failure, acute myocardial infarction, stroke or transient ischemic attack, unstable angina pectoris.
* History of malignancy or malignant neoplasm in place, severe inflammatory complications, neurological or cardiovascular in act.
* Pregnancy
* Any conditions that at the discretion of the head of the study can represent risk to the participant or could affect the protocol results.
Study of NPO-11 in Patients Undergoing Gastrointestinal Endoscopy

Chinese patients who require gastrointestinal endoscopy will receive an intra-gastric single dose of NPO-11 20ml. The superiority of NPO-11 compared to placebo as a premedication for endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients having no gastric peristalsis.

The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions observed between informed consent and 7 days after administration in comparison with the placebo group.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are capable of understanding and complying with protocol requirements in the opinion of the investigator or the sub-investigator.
2. Patients who are able to fill in the informed consent form.
3. Patients who require gastrointestinal endoscopy using a scope of 9mm or greater diameter for follow-up of confirmed or investigation of a suspected upper gastrointestinal disease. (except for transnasal endoscopy and emergency endoscopy)
4. Male or female chinese patients aged _18_ to _80
5. Patients who agree to use routinely adequate contraception from signing of informed consent to follow-up.

Exclusion Criteria:

1. Patients have received any investigational drug of other study within 120 days prior to providing their informed consent.
2. Patients had been administered NPO-11 in the past.
3. Patients who are the study site investigator or sub-investigator, an immediate family member (eg, spouse,parent, child, sibling), or may consent under duress.
4. Patients have a history of upper gastrointestinal tract surgery.
5. Patients have gastric stenosis or deformity that would make observation of peristaltic movement difficult.
6. Patients have bleeding in the upper gastrointestinal tract and require hemostatic intervention.
7. Patients have reflux esophagitis (defined as Los Angeles Class: B, C or D)
8. Patients have an active gastric or duodenal ulcer (defined as Sakita-Miwa class: A1 or A2)
9. Patients are on treatment (radiotherapy or chemotherapy) for cancer.
10. Patient have decreased heart function (NYHA heart function class: III or more)
11. Patients have a history of shock, hypersensitivity or allergies to l-menthol or peppermint oil.
12. Patients have a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 12 months prior to the screening visit.
13. Patients are required to take excluded medications.
14. If female, patients are pregnant or lactating or intending to become pregnant from signing of informed consent to follow-up.
15. Any subject who, in the opinion of the investigator or the sub-investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With Dacarbazine

This is a Phase I, open-label, dose-escalating, study of the safety and tolerability of KU-0059436 in combination with DTIC in the treatment of patients with advanced melanoma who have not previously received systemic cytotoxic chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have:

  1. Unresectable stage 3 or stage 4 cutaneous melanoma or unknown primary melanoma with metastases.
  2. Histological or cytological confirmation of melanoma. Histological confirmation of melanoma from the primary site will suffice, unless the primary site is unknown.

Exclusion Criteria:

* Previous treatment with cytotoxic chemotherapy for advanced melanoma, apart from treatment for melanoma with isolated limb perfusion.
* Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or use of other investigational agents within 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).
* Major surgery within 4 weeks of starting the study.
Exparel vs Exparel Plus ACB in TKAs

Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block, standard of care for this procedure, or Exparel alone for pain management after surgery. They will also be asked to complete questionnaires before surgery, during their stay at the hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain and/or function levels, as well as the amount of pain medicine patients have used after surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6 and 12 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 80 years at the time of surgery.
* Willing and able to give voluntary informed consent to participate in this investigation.
* Candidate for total knee arthroplasty.
* BMI \< 35.

Exclusion Criteria:

* Subject has had previous arthroplasty or fracture procedure(s) on the operative knee.
* Creatine level ≥ 1.5
* Pre-existing gait disturbance or neuropathy.
* Allergy to local anesthetics.
* Inflammatory arthropathies.
* Female patient who is pregnant or nursing.
* Chronic use of narcotics
* Any other reason (in the judgment of the investigator).
A Study of Ultrasonography With Elastography in Skin Neoplasms

This study will look at high frequency ultrasound as a medical imaging modality and apply it to skin lesions. Elastography is an ultrasonic method of looking at the hardness of an area. We will use this to try and differentiate between benign and cancerous skin lesions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with skin lesions undergoing biopsy for diagnosis.

Exclusion Criteria:

* Patients with skin lesions which do not require biopsy for diagnosis.
Tenofovir-DF Versus Hydroxychloroquine in the Treatment of Hospitalized Patients With COVID-19 (TEDHICOV)

Although several therapeutic agents have been suggested for the treatment of the disease caused by the Coronavirus of the year 2019 (COVID-19), no antiviral has yet demonstrated consistent efficacy.

This is an observational study comparing Tenofovir-DF (disoproxil fumarate) (TDF) with Hydroxychloroquine (HCQ) in the treatment of hospitalized patients with COVID-19 with evidence of pulmonary compromise and with supplemental oxygen required.

All hospitalized patients with COVID-19 from March 2020 to May 30, 2020 at the "Hospital Nacional Carlos Alberto Seguín Escobedo (CASE)-EsSalud" (Arequipa, Peru) with a PCR-confirmed diagnosis of SARS-CoV-2 will be included.

The primary outcomes to be compared will be mortality, the need for admission to the Intensive Care Unit (ICU) and / or Mechanical Ventilation, and LOS (length of stay) in both groups.

Furthermore, demographic factors, risk factors, vital / respiratory functions, and laboratory results of both groups will be compared. The tests closest to the time of admission to the hospital will be taken into consideration.

Statistical Analysis: quantitative variables will be expressed as mean ± standard deviation, qualitative variables will be expressed as percentages (%). In the univariate analysis, the Student's t test will be used for the means and the chi2 test for nominal or ordinal variables. Kaplan-Meier survival curves will be evaluated 30 days after admission to the hospital to assess mortality. The multivariate analysis of the variables that result significant in the univariate analysis will be carried out by the Cox regression model in the evaluation of mortality; the multivariate linear regression model for the evaluation of the stay and the "log rank" model for the evaluation of admission to the Intensive Care Unit (ICU) or the need for mechanical ventilation (MV). In addition, models will be developed to estimate the effects of TDF treatment by regression adjustment for the primary outcomes of this observational study: hospital stay, need for ICU (intensive care unit) and / or MV (mechanical ventilation) and mortality. The Stata® software version 14 will be used and p \<o.o5 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adults over 18 years of age
* Positive molecular test for SARS-CoV-2
* Computed tomography (TC scan) compatible with "COVID pneumonia" and / or in need of supplemental oxygen
* Therapy with Tenofovir-DF (TDF) or Hydroxychloroquine (HCQ) at least 3 days
* Signed informed consent

Exclusion Criteria:

* Negative molecular test for SARS-CoV-2
* No need for hospitalization
* Negative CT scan for "COVID pneumonia" and / or no supplemental oxygen requirement for COVID-19
* Had not received either HCQ or TDF, or both drugs at the same time, or had received HCQ or TDF for two days or less
* No signed informed consent
Combination of QLS31905, QL2107 and Chemotherapy as First-line Therapy in CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

QLS31905 is a bispecific antibody targeting CD3 and CLDN18.2 independently developed by Qilu Pharmaceutical Co., Ltd.

QL2107 is a biosimilar of pembrolizumab (Keytruda®) developed by Qilu Pharmaceutical Co., Ltd.

This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histopathological or cytological examination;
* Subjects with at least one measurable lesion designated as a target lesion, as assessed by the investigator according to RECIST v1.1. Lesions that have received radiotherapy or other local treatments may be considered measurable if they demonstrate imaging PD;
* No prior systemic anti-tumor treatment for locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Exclusion Criteria:

* Subjects with a known history of severe or repeated allergy, intolerance, or contraindication to QLS31905, QL2107, or other large molecule protein preparations, as well as Oxaliplatin Injection or Capecitabine Tablets and any components in their preparations;
* Subjects had other second primary malignancies within 5 years prior to the first dose;
* Subjects with clinically significant hemorrhage within 3 months before the first dose
The Safety of Thoracentesis, Tunneled Pleural Catheter, and Chest Tubes in Patients Taking Novel Oral Anti-Coagulants

To assess risks of bleeding in those individuals receiving Novel Oral Anti-Coagulant (NOAC) medications, admitted to the hospital and require thoracentesis, chest tube or tunneled pleural catheter placement.

The research component of this study simply observes and documents the outcomes of these procedures. Patients will undergo an analysis of their pre-procedural hematocrit and this will be compared to their post-procedural (next day) hematocrit.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 y/o
2. Unilateral or bilateral pleural effusion
3. Ability to provide consent or consent given for the procedure and research study

Exclusion Criteria:

Adults who refuse to provide consent.
High-Risk prostatE Cancer radiatiOn Versus surgERy

Prospective cohort study comparing robot-assisted radical prostatectomy and external beam radiotherapy combined with androgen deprivation therapy for high-risk non-metastatic prostate cancer in terms of health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival and distant metastasis-free survival.

Detailed description: Robot assisted radical prostatectomy (RARP) and external beam radiotherapy (EBRT) combined with Androgen Deprivation Therapy (ADT) are widely used treatment modalities for high-risk non-metastatic prostate cancer (HR-PCa). Both treatments are associated with adverse effects and can have a great impact on health-related quality of life (HRQoL). To date there is no consensus on which of both is the optimal treatment for men with HR-PCa, as it is unclear which treatment is superior in terms of HRQoL, cost-effectiveness, progression-free survival (PFS) and distant metastases-free survival (DMFS). This is reflected in substantial variation between individual hospitals in the utilization of both treatment options that is not explained by patient- and tumor characteristics or patient preferences. In the RECOVER study we aim to address this knowledge gap. The insights gained can be used to tailor recommendations in (national) guidelines and in shared decision-making tools. This allows healthcare professionals to better inform their patients and allows patients to make well-informed choices.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed de novo non-metastatic high-risk prostate cancer.
* cT3a-bN0M0, according to the 8th edition of the Tumour, Node, Metastasis (TNM) classification, with the exception that clinical T-stage will be based on digital rectal examination and magnetic resonance imaging (the highest stage will be used) and/or
* International Society of Urological Pathology (ISUP) grade ≥4 and/or
* Prostate-Specific Antigen (PSA) value at diagnosis greater than 20 ng/mL
* Fit for treatment with either RARP or EBRT and ADT (WHO performance status 0-1)
* Living in the Netherlands
* Able to read and understand the Dutch language

Exclusion Criteria:

* Histological types other than adenocarcinoma
* Diagnosis and/or treatment in a hospital abroad
* Treatment with Androgen Receptor Targeted Agents (ARTA) as part of the initial treatment plan