cyrilzakka/clinical-trials huggingface dataset:
Ultra-sounded Guided Regional Blockade for Lipoma Excision

There is limited information on using the ultrasonography for block placement concerning lipoma excision. A new type of regional blockade, performed under ultrasound, can ensure proper block placement with accurate local anesthetics deposition. Investigators hypothesized that ultrasound guidance can reduce the number of needle passes to complete the block placement. Investigators will compare namely ultrasound guided regional blockade and traditional method regarding the number of needle passes to complete the block placement.

50 patients between the ages of 18 and 60 years with American Society of Anesthesiologists (ASA) physical status I-III, scheduled for superficial subcutaneous lipoma (sized from 5 to 7 cm) excision will be enrolled in prospective comparative randomized clinical study.

Patients will be randomized into two groups: U (n = 25), in whom regional blockade was performed using US-guidance; and C (n = 25), in whom regional block was performed using the traditional method. Patients will be randomly assigned on a one-to-one ratio. Randomization will be performed by means of a computer generated random-numbers table. Group allocation will be concealed in sealed opaque envelopes that will not opened until patient consent had been obtained.

All patients will be pre-medicated with oral diazepam (7.5 mg) 30 min before the procedure, and IV fentanyl (50 ug) will be administered 5 minutes before placement of the block. Before the procedure, an IV access and standard monitoring of electrocardiogram (ECG), noninvasive blood pressure (NIBP), and peripheral oxygen saturation (SPO2) will be established.

Primary outcome includes the number of needle attempts (number of skin punctures and needle redirections) needed to complete the block placement. It will be documented by an investigator blinded to the aim of the study. Patient demographics, duration of surgery, patient's ASA physical status and other study outcomes will be documented by independent investigators who were not involved in the block placement procedure and were blinded to the group assignment.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 60 years
* American Society of Anesthesiologists (ASA) physical status I-III
* Superficial subcutaneous lipoma excision surgery (sized from 5 to 7 cm)
* Able to provide informed consent
* Consent to participates
* Single procedure

Exclusion Criteria:

* Unable to consent
* Do not consent to participate
* Patients with local infections in the skin over lipoma
* Patients with history of allergy to local anesthetics
* More than one procedure is being performed at the same setting
Comparison of Three Different Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury

The purpose of this study is to compare three assisting devices to propel personal wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual wheelchair in patients with spinal cord injury.

The objective of the study is to compare three assisting devices to propel personal wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual wheelchair in patients with spinal cord injury.

The study consists of three distinct and independent phases:

* Phase 1: Performance evaluation on wheelchair ergometer in order to compare the energy expenditure and kinetic characteristics in comparable situations with regard to speed and workload imposed to the wheelchair-patient couple.
* Phase 2: Comparison of maneuverability and ease of crossing usual obstacles in outdoor and indoor paths with standardised obstacles. Trajectories are to be recorded in order to allow analysis by independent experts.
* Phase 3: Comparison of the autonomy of patients afforded by the devices by comparing the patient's ability to transfer from wheelchair to car seat and from car seat to wheelchair, as well as ease of wheelchair packing in car, in the context of a standard city transport involving a car and the wheelchair.

The three phases are to be performed using the standard manual wheelchair and the three assisting devices in a randomized order.

Three different groups of patients are included in the three phases of the study.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 70 years
* Spinal cord injury C5-C8, paraplegic D1-D11, and D11 paraplegic below only for phases 1 and 2 phase 1 and 2
* Spinal cord injury D1 and above only for phase 3
* Having given free and informed consent
* Negative pregnancy test for women of childbearing age

Exclusion Criteria:

* No affiliation to a social security scheme
* Refusal to participate in the clinical trial
* Patient under guardianship
* Major cognitive disorders
* bedsores
* Functional abnormality of the shoulder
* History of cardiovascular disease
* ECG to suspect coronary insufficiency
* Pregnant patients without effective treatment or contraceptive
* Acute complication or systemic organ
Effectiveness of Catheter Reminder and Evaluation Program

The investigators will conduct a cluster randomized controlled trial to evaluate the efficacy of Catheter Reminder and Evaluation program (CARE) in reducing the duration of catheter use and the number of infection relating to catheter use.


Eligibility Criteria:
Inclusion Criteria:

* All hospitalized adults in 6 general medical wards at Siriraj Hospital
* With or Without catheter

Exclusion Criteria:

* None
Perianal Nerval Block in Proctological Interventions

The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.

The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.

All patients will undergo surgery under general or spinal anesthesia. At the end of the surgery, the surgeon will perform a perianal block using the local anesthetic or the placebo upon randomisation. The experimental group will receive a local anesthetics and the control group a normal saline injection. All injections will be perianal, peripheral to the external anal sphincter.

Eligibility Criteria:
Inclusion Criteria:

* Patients with surgical indication for hemorrhoids, fistula-in-ano or anal fissures.
* Age of 18 or above

Exclusion Criteria:

* age under 18.
* Patients unable to understand an informed consent.
* Emergency operations
* Pregnant women.
* Patients with acute perianal infection.
* Patients allergic to any component of the local anesthetic
Rebeccamycin Analogue in Treating Patients With Refractory Stage III or Stage IV Ovarian Epithelial Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating patients who have refractory stage III or stage IV ovarian epithelial cancer.

OBJECTIVES: I. Determine the response rate to rebeccamycin analogue in patients with refractory stage III or IV ovarian epithelial cancer who have failed platinum in combination with paclitaxel chemotherapy. II. Determine the toxicities of this treatment regimen in these patients.

OUTLINE: Patients receive rebeccamycin analogue IV over 60 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients with complete response after receiving 3 courses receive 3-6 additional courses. Patients with partial response or stable disease after receiving 3 courses receive 3-12 additional courses. Patients with complete response are followed every 2 months for 2 years, and then every 3 months thereafter. All other patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-39 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer Platinum resistant disease as defined by disease progression during or within 6 months of receiving prior paclitaxel combined with cisplatin or carboplatin No elevated CA-125 as only evidence of disease recurrence Measurable disease At least 20 mm in diameter by conventional techniques OR At least 10 mm in diameter by spiral CT scan No known brain metastases

PATIENT CHARACTERISTICS: Age: 21 and over Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST and ALT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance greater than 60 mL/min Other: No history of allergic reactions to compounds of similar chemical or biologic composition to rebeccamycin analogue No other prior cancer within the past 5 years except nonmelanomatous skin cancer No other medical problems that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent therapeutic agents for cancer
Erythema Migrans in Elderly

The investigators will focus on elderly patients with early Lyme borreliosis with the aim of assessing clinical course, serological response and treatment outcome of the disease as compared to younger adults. Furthermore, the investigators will compare the prevalence of nonspecific symptoms among patients and among age-matched controls without a history of Lyme borreliosis.


Eligibility Criteria:
Inclusion Criteria:

* erythema migrans

Exclusion Criteria:

* pregnancy or lactation
* immunocompromised
* taking antibiotic with antiborrelial activity within 10 days
* received \<10 days of antibiotic therapy for erythema migrans
* had an intercurrent episode of Lyme borreliosis during follow-up
Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC

Patients will be randomized in a 1:1:1 ratio to receive treatment with MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or Standard of Care (SoC) therapy.

Eligibility Criteria:
Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

* Aged at least 18 years
* Documented evidence of Stage IV NSCLC
* No sensitizing EGFR mutation or ALK rearrangement
* No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
* World Health Organization (WHO) Performance Status of 0 or 1

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
2. Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
3. Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\]
COVID-19 Vaccination AZV 2021-2023

The study is aimed at the clinical and laboratory characteristics of patients with completed vaccination against SARS-CoV-2 admitted to the hospital in the standard ward and intensive care unit due to the severe course of COVID-19.

The high number of patients hospitalized for COVID-19 significantly affects the entire healthcare system, where 70-80% of the total number of patients are unvaccinated, however, approximately 20-30% of patients hospitalized for the disease COVID-19 have undergone vaccination. The investigators assume the existence of several phenotypes of infection even in vaccinated patients, which may differ both in the rate of antibody formation, the dynamics of indicators of persistent virus replication, and the intensity of a potentially self-destructive inflammatory reaction and activation of coagulation. Early identification of patients with completed vaccination who have a higher risk of a severe course of COVID or a demonstrable inadequate immune response will allow individualization of treatment. Finding out the risk characteristics of the patients is a question and the difference in the type of vaccine on the severity of the course of hospitalization and the clinical outcome of the patients can contribute to the optimization of the vaccination strategy of the population and to the early identification of risk groups of vaccinated persons from the point of view of the timely deployment of available post-exposure prophylaxis/treatment procedures.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* COVID-19 positiveness
* vaccination against SARS-CoV-2 (any number of doses)

Exclusion Criteria:

* N/A
Patterns of Care and Outcomes in Patients With Metastatic Bone Tumors (METABONE)

Bone tumors make up about 3-5% of childhood cancers and less than 1% of cancers in adults. Of these, osteosarcoma (OSS) is the most commonly diagnosed primary malignant bone tumor. OSS is a primary mesenchymal malignant tumor of bone characterized by the production of osteoid or immature bone by the malignant cells. Despite its rarity, OSS is the most common primary malignancy of bone in children and adolescents, and the fifth most common malignancy among adolescents and young adults aged 15 to 19 years.

Ewing sarcoma (ES) is the second most frequent bone tumors in children and may arise also in soft tissues. This disease encompasses tumors formerly known as Askin's tumor, Peripheral Neuroectodermal Tumor (PNET) and the Ewing Sarcoma Family of Tumors (ESFT).

Chondrosarcoma are rare sarcoma reputed chemorefractory in the non-operable setting and for which little is known in terms of palliative management with systemic treatments.

Despite adequate loco-regional treatment, up to 40% of patients with sarcoma, soft tissue or bone, will develop metastatic disease. When metastases are detected, the standard of care is based on palliative chemotherapy with a median survival in this setting of only 18 months.

A slight improvement has been obtained over years thank to registration of a couple of drugs such as Trabectedin and Pazopanib, the first antiangiogenic registered for soft tissue sarcoma patients. Pazopanib is routinely prescribed worldwide after failure of first line chemotherapy in soft tissue sarcoma. However, bone tumors have not benefited from these small advances yet and treatment still rely on chemotherapy combining doxorubicine cisplatinum and ifosfamide. There is no standard in relapse and palliative settings, and after failure of these agents the survival is very poor. Bone sarcomas are therefore tumors with very little available data and low level of evidence on palliative systemic treatments in clinical trials and in the real life setting.

The primary objective of the METABONE study is to conduct a retrospective descriptive analysis of clinic-biological profiles, patterns of care and modalities of treatment for a set of patients with malignant bone tumors in a real-life national setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages
* Informed consent obtained for inclusion in the databases
* Histology of Ewing's sarcoma type, osteosarcoma, chondrosarcoma
* Diagnostic between 2007 and 2016
To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥40 and ≤ 80years of age
* Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren \& Lawrene radiographic entry criteria
* Stable osteoarthritis during 3 months
* Score of 100mm pain VAS ≤ 80mm at screening
* Score of 100mm pain VAS ≥ 50mm at baseline
* Written consent form voluntarily

Exclusion Criteria:

* Disease of spine or other Lower limb joints that could affect to evaluate the efficacy
* History of surgery or arthroscopy of the study joint within 6 months
* Trauma of study joint within 12 months
* Medication of constantly(more than 1 week) corticosteroid by oral within 3 months
* Medication of intra-articular injection within 3 months
* Diagnosed with psychical disorder, and taking medication
* History of upper gastrointestinal ulceration within 6 months
* History of upper gastrointestinal bleeding within 12 months
* Serum creatinine, ALT, AST, total bilirubin over UNL X 2.0 at screening test
* History of hypersensitivity to LAYLA, JOINS, or NSAIDs
* Participation in another clinical trials within 4 weeks
* Medication of constantly (more than 1 week) narcotic analgesics within 3 months
* Not consent about using effectual contraception method during trial
* Pregnant or lactating woman
* Investigator's judgment
Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib

The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Phase (CP)-CML Ph+ patients with complete hematologic response (CHR) but without one log BCR-ABL reduction (BCR-ABL level \>10% IS) 3 months of imatinib 400mg treatment. (Imatinib transient dose adjustments due to Adverse Event (AEs) are allowed with a maximum of 2 weeks interruption of treatment with imatinib (cumulative) within the 3 month period before randomization). Imatinib monotherapy must have been started within 6 months of CP-CML diagnosis (Ph + /BCR-ABL detection)
* Currently tolerating imatinib 400mg QD. Patients with prior imatinib treatment interruption or dose reductions are required to be on treatment with 400 mg imatinib for two weeks immediately prior to randomization to ensure tolerance to imatinib
* Eastern Co-Operative Group (ECOG) performance status = 0 - 2
* Adequate renal function defined as serum creatinine ≤3 times the institutional upper limit of normal (ULN)
* Adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the institutional ULN

Exclusion Criteria:

* Previous diagnosis of accelerated phase or blast crisis
* Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases at baseline bone marrow cytogenetic test, unless the same abnormalities were present at diagnosis. Patients with no evidence of clonal evolution, including those patients whose cytogenetic testing fails or bone marrow aspiration is a dry tap at 3 months, are eligible for the study
* Subjects with less than CHR after 3 months of imatinib treatment or lost CHR after initial achievement
* Documented T315I/A, F317L, or V299L mutations (if already available - not required for screening)
* A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
Portal Vein Thrombosis in Cirrhosis

This study evaluates the supervivence of cirrhotic patients that develop portal vein thrombosis in comparison to cirrhotic patients that do not develop portal vein thrombosis.

Patients newly diagnosed with portal vein thrombosis by imaging tests, that evaluate the extent and exclude tumoral origin, will be included (informed consent previously signed).

Anticoagulant treatment will be initiated according to clinical guidelines (if there is no contraindication) first with LMWH (low molecular weight heparin) and later with dicoumarin.

An abdominal CT will be performed to evaluate the extent and exclude tumoral origin; a gastroscopy to evaluate portal hypertension (and do prophylaxis if required) and thrombophilia study.

Patients will be followed by imaging and laboratory tests every 6 months; to evaluate the response to the treatment and detect any cirrhosis complication.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis diagnosed by liver biopsy or non-invasive methods/clinical, analytics or ultrasound usual criteria
* Portal vein thrombosis of newly diagnosed (defined as partial or complete obstruction of splenoportal vessels objectified by imaging with/without symptomatology) ≤ 6 months.
* Over 18 years old
* Want to participate (informed consent)

Exclusion Criteria:

* Pregnant or lactating
* Patients with tumoral vein thrombosis or elevated alpha-fetoprotein or high suspicion of underlying neoplastic disease.
* Thrombocytopenia \< 25.000 .
* Patients with cavernomatosis or portal vein thrombosis already known.
* Patient refusal to participate
* Patients already treated with anticoagulants for other diseases (atrial fibrillation, pulmonary thrombosis...)
Fluid Resuscitation in Septic Shock Patients With BMI Elevation

To explore the safety and feasibility of alternative fluid resuscitation strategies in obese patients with septic shock.

Early, goal-directed therapy with timely achievement of hemodynamic stability has been shown to clearly improve outcomes in patients with septic shock. Although Surviving Sepsis Campaign guidelines recommend a weight-based approach to initial fluid resuscitation (i.e. 30ml/kg),1 at present, there are no robust data to support whether dosing based on actual body weight or an alternative correction formula (ideal body weight, adjusted body weight) is superior.

FRISSBE is a prospective, randomized, three-arm parallel-group pilot trial of alternative resuscitation strategies for obese patients with septic shock, looking at feasibility and safety of different weight-based approaches. Subject treatment assignment will not be blinded. Data will be collected and analyzed on an intent-to-treat basis. The study will enroll 60 subjects, with 20 subjects per treatment arm. Subjects will be randomized to receive one of three weight-based initial fluid resuscitation strategies - 30cc/kg ideal body weight (IBW), 30cc/kg adjusted body weight (AdjBW), or 30cc/kg actual body weight (ABW).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* BMI \> 30
* suspected infection, and either:

  * hypotension (a systolic blood pressure \< 90mmHg) or
  * blood lactate concentration \> 4mmol/L

Exclusion Criteria:

* Pregnant
* Primary diagnosis of acute cerebral vascular event
* Acute coronary syndrome
* Acute pulmonary edema
* Status asthmaticus
* Major cardiac arrhythmia
* Active gastrointestinal hemorrhage
* Seizures
* Drug overdose
* Burns or trauma
* Requirement for immediate surgery
* CD4\<50/mm3
* Do-not-resuscitate order status
* Transferred from another hospital