cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Guided Sacral Erector Spina Plane Block as a Main Anesthetic Method

The goal of this retrospective observational study is to demonstrate investigators' experience of Ultrasound guided Sacral Erector Spina Plane Block as an anesthetic technique in patients underwent sacral plastic and reconstructive surgeries.

The main question\[s\] it aims to answer are:

* block indication, level
* results, side effects and complications

Erector Spina Plane Block is an interfascial plane block that is performed by injecting the local anesthetic solution between transverse process of the vertebra and erector spina muscle. It is found to be an inexpensive,easily applied, effective and safe technique for chronic pain.(1) Ultrasound guided Erector Spina Plane Block(ESP) is getting more and more widely used for analgesia and as an anesthetic technique.(2,3) Regional anesthesia techniques provide safer, more stable and advantageous anesthetic management, especially in high-risk patients. Ultrasound guided Sacral ESP is described by Tulgar et all.in 2019 and can be used either for analgesia or as an anesthetic technique. (4) In this retrospective study investigators planed to demonstrate one year of experience of this block for sacral plastic and reconstructive surgery. Demographic data of patients who underwent sacral surgery with sacral ESP block, indication of block, level of block, drug dose concentration, effect, side effect and results that were recorded will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* being going for a sacral surgery
* American Society of Anesthesiology status (ASA) 1 - 4

Exclusion Criteria:

* emergency
* ASA-5
Documentation of In-flight Medical Emergencies With Medical Incident Report Forms.

The purpose of this study is to perform a descriptive, content-based analysis on the different forms of documentation for in-flight medical emergencies that are currently provided in the emergency medical kits on board commercial airlines.


Eligibility Criteria:
Inclusion Criteria:

* medical incident report form

Exclusion Criteria:

* no medical incident report form
Mental Health Assessment Project on the Thailand-Burma Border

The aim of the study is to determine the effectiveness of a transdiagnostic psychotherapy intervention - namely, Common Elements Treatment Approach (CETA) - in reducing the severity of mental health symptoms experienced by torture and violence survivors displaced from Burma into Thailand. Specifically, the intervention seeks to measure reductions (if any) in symptoms of depression and trauma.

The study is part of an award by the USAID Victims of Torture Fund (USAID/VTF) to JHU to work with local and international organizations serving survivors of torture and systematic violence. For this study, the intent is to assist in the design, implementation, monitoring, and evaluation of programming to understand and address the psychosocial needs of Burmese displaced across the Thai/Burma border who are living in the area of Mae Sot, Tak Province in Thailand. Specifically this project involves collaboration with the Burma Border Projects (BBP), the Mae Tao Clinic (MTC), the Assistance Association for Political Prisoners (AAPP), and Social Action for Women (SAW), to help improve the quality and effectiveness of psychosocial and mental health programs.

The Common Elements Treatment Approach (CETA) is a transdiagnostic treatment approach developed for delivery by lay counselors in low and middle income countries (LMIC) with few mental health professionals. CETA was designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety, and to provide skills to deal with life stressors. includes engagement, psychoeducation, anxiety management strategies, behavioral activation, cognitive coping/restructuring, imaginal gradual exposure, suicide/homicide/danger assessment and planning, and screening and brief intervention for alcohol.

Eligibility Criteria:
Inclusion Criteria:

* Burmese national, 18 or over, living in Thailand outside of refugee camps, meets or exceed the algorithm for the Hopkins Symptoms Checklist 25 (HSCL-25) depression subscale and/or the algorithm for the Harvard Trauma Questionnaire (HTQ) posttraumatic stress scale.

Exclusion Criteria:

* not Burmese national, under 18, not living in Thailand outside of refugee camps, does not meet meet or exceed the algorithm for the Hopkins Symptoms Checklist 25 (HSCL-25) depression subscale and/or the algorithm for the Harvard Trauma Questionnaire (HTQ) posttraumatic stress scale; active psychosis
Phase I/II Study of Linperlisib Plus Chidamide for R/R Peripheral T-cell Lymphoma: a Prospective, Multi-center Study

HDAC inhibitor chidamide and PI3K inhibitor linperlisib has shown clinical activity as mono-therapy in PTCL. The combination of duvelisib and romidepsin is highly active for relapsed and refractory PTCLs. The aim of this study is to further explore the efficacy and safety of HDAC inhibitor chidamide combined with PI3K inhibitor linperlisib in the treatment of relapsed and refractory PTCLs.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-75;
* Pathologically confirmed diagnosis of PTCL, not otherwise specified (PTCL, NOS), anaplastic large cell lymphoma (ALCL), angioimmunoblastic T-cell lymphoma (AITL), or other PTCL subtypes that the researchers considered to be eligible;
* Fulfills the criteria for relapsed/refractory lymphoma;
* There must be at least one measurable lesion: for measurable lymph node, the longest diameter should be \> 1.5cm, for measurable extranodal lesion, the longest diameter should be \> 1.0cm;
* ECOG score of 0-2;
* Adequate bone marrow hematopoietic function: neutrophil count (ANC)

  ≥1.5×109/L, platelet count (PLT) ≥80×109/L, hemoglobin (HGB) ≥90g/L;
* Adequate organ function: NYHA grade 1-2, LVEF≥50%, ALT\<3UNL, TBil\<2ULN, SPO2 \> 93%@RA, SCr\>60ml/(min·1.73m2);

Exclusion Criteria:

* Extranodal natural killer/T cell lymphoma;
* Previously treated with PI3K inhibitors;
* Acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmia, and significantly prolonged QT interval (\> 450ms in men and \> 470ms in women) within 6 months;
* Uncontrolled active infections;
* Active hepatitis B and C infection (hepatitis B virus DNA over 1×103 copies /mL is excluded, hepatitis C virus RNA over 1×103 copies /mL is excluded);
* Pregnant or lactating women;
S9925: Collecting and Storing Samples From Patients With Lung Cancer

RATIONALE: Collecting and storing samples of tissue, blood, and sputum from patients with cancer to study in the laboratory may help the study of cancer in the future.

PURPOSE: The purpose of this study is to collect and store tissue, blood, and sputum samples from patients with lung cancer to be tested in the laboratory.

OBJECTIVES:

* Establish a central lung cancer specimen repository to serve as a resource for current and future scientific studies.
* Correlate clinicopathologic information in the Southwest Oncology Group clinical data base with results of studies using the repository.
* Test new hypotheses with the specimens in the repository.

OUTLINE: Peripheral blood, sputum, and biopsy specimens are collected from patients. Tissue samples are frozen and stored in a lung cancer specimen repository for later use in correlative studies.

PROJECTED ACCRUAL: Not specified

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Enrolled on one of the following Southwest Oncology Group protocols:

  * SWOG-8805, SWOG-9019, SWOG-9416, SWOG-9509, SWOG-S9900, SWOG-S0003, SWOG-S0023, SWOG-S0126, SWOG-S0435, SWOG-S0220, SWOG-S0222, SWOG-S0327, SWOG-S0310, SWOG-S0339, SWOG-S0342, SWOG-S0341, SWOG-S0509, SWOG-S0429, or SWOG-S0124

PATIENT CHARACTERISTICS: Not specified

PRIOR CONCURRENT THERAPY: Not specified
Long-Term Efficacy and Safety of Asenapine Using Haloperidol as a Positive Control (41513)(COMPLETED)(P05785)

Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other.

The clinical development of asenapine, as described in the 2007 IDB appears to have antipsychotic activity with superior symptomatic control compared to placebo and an improved safety profile compared to currently available neuroleptics. Its fast dissolving formulation may further add to treatment compliance. While various titration schedules have been used in previous studies, dose increases at 5 mg BID (twice daily) up to 10 mg BID have been well tolerated. Therefore, further exploration in a larger group of subjects with acute exacerbation of schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID) will mimic actual clinical practice in a long-term 52-week extension trial.


Eligibility Criteria:
Inclusion Criteria:

* Completed the short-term 041023 trial (NCT00156104)
* Continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial
* Sign a written informed consent for the 041513 trial.
* Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator

Exclusion Criteria:

* CGI-S (Clinical Global Impressions of Severity of Illness) score of greater than or equal to 6 (severely psychotic)
* Occurrence(s) of AEs (adverse events) or other clinically significant findings that would prohibit their continuation
* Met any of exclusion criteria regarding medical/psychiatric status listed in the 041023 short-term trial
* Met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.
Malnutrition Using GLIM Criteria and Comparing CT and BIA for Muscle Mass Measurement

Evaluation of malnutrition with the help of the GLIM criteria. Muscle mass measurement, as recommended in the GLIM criteria was done with the help of abdominal CT scan and BIA. Both methods were compared and their association to the clinical outcome was assessed.

We retrospectively analysed 260 patients undergoing major abdominal surgery between January 2017 and December 2019. Patients were prospectively screened and assessed for malnutrition with Nutritional Risk Score (NRS) and Subjective Global assessment (SGA). Body composition was analysed with CT scan and BIA within 30 days before surgery. GLIM criteria were retrospectively determined referring to the Fat free Mass from BIA (FFMBIA) and Muscle Mass from axial CT scan at lumbar level 3 (MMCT). The prevalence of GLIM - malnutrition according to BIA and CT was evaluated. Multivariate logistic regression analysis was used to determine association between malnutrition and outcome parameters. ROC-curves specified sensitivity and specificity of the different tools and areas under the curve were calculated.

Eligibility Criteria:
Inclusion Criteria:

* age above 18 years
* BIA and CT scan was available within 31 days before surgery
* patients undergoing major abdominal surgery for gastrointestinal cancer

Exclusion Criteria:

* patients who were not able to agree to the participation
* missing assessment of the nutritional status
* leck of quality of the CT scan
GI Complications in Cancer Immunotherapy Patients

The purpose of this study is to establish a prospective observational cohort of cancer immunotherapy patients with GI side effects in order to identify biomarkers that predict GI complications due to treatment.

Primary objective

* To create a data and bio-specimen repository to enhance both safety and efficacy of immunotherapy

Secondary objective

* Identify biomarkers that may predict GI toxicity in cancer patients undergoing immunotherapy
* Define the clinical course of intestinal inflammation and identify genetic factors of therapeutic response to GI medications
* Analyze genotype-phenotype correlations in GI side effects in patients undergoing cancer immunotherapy

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cancer
* Currently undergoing or have undergone immunotherapy

Exclusion Criteria:

* History of a total colectomy
* History of inflammatory bowel disease (either ulcerative colitis or Crohn's disease)
* History of colitis on chemotherapy
Acetazolamide to Prevent Post Operative CSF Leak

The purpose of this research is to test the use of Acetazolamide in preventing post-operative cerebrospinal fluid leak in patients having endoscopic skull base surgery (it is a surgery performed through the nose and sinus).


Eligibility Criteria:
Inclusion Criteria:

* Elective transsphenoidal resection of a tumor expected to result in an intraoperative high flow CSF leak; such tumors include craniopharyngioma, meningioma, and Rathke cleft cyst.
* Elective transsphenoidal resection of a pituitary adenoma, with BMI \>25, or with observed low or high flow CSF leak during surgery, conferring an elevated risk of postoperative CSF leak.
* Patients who voluntarily sign Informed Consent
* Male subjects and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception during study treatment and for at least 1 month after stopping study treatment. Male subjects should refrain from donating semen during treatment and 1 month after stopping treatment.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Patients with prior adverse reactions to acetazolamide or who are taking aspirin concomitantly (which may increase the risk of adverse reactions to acetazolamide)
* Patients with moderate to severe chronic obstructive pulmonary disease (which may increase the risk of adverse effects of acetazolamide)
* Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis.
* It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy
* Sulfonamide allergy
* Pregnant females, breastfeeding females, and males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception
The Opioid-sparing Effect and Reduced PONV Using Propacetamol in PCA Among Patients With High Risk of PONV

While Patient-controlled analgesia (PCA) has the advantage of effectively reducing the degree of postoperative pain, it can also affect the patient's outcome by several adverse effects such as postoperative nausea and vomiting (PONV). Especially for high risk group of patients for PONV, the ideal regimen for sufficient analgesia with minimal adverse effect needs to be sought. Propacetamol is known for its effective, rapid analgesia, opioid-sparing effect, and is used widely for post operative pain management. This study aims to see the opioid-sparing effect and the degree of PONV when propacetamol is added to PCA for high risk PONV patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for either 1-2 level spine fusion or laminectomy
2. ASA (American Society of Anesthesiology) physical status 1 or 2
3. Non-smoking female patients, between the age 20 and 65

Exclusion Criteria:

1. Administration of any anti-emetic agents within 24 hours prior to surgery
2. Administration of any opioid agents within 7 days prior to surgery
3. Regular administration of any steroid agents
4. Drug or alcohol-abuser
5. Patients with bowel movement disorder, liver or renal impairment, insulin-dependent diabetes. Patients who are pregnant, illiterate, or foreign.
6. Patients administered to Intensive Care Unit after surgery
Methods of Computed Tomography Screening and Management of Lung Cancer

European lung cancer screening studies using computed tomography (CT) have shown that a management protocol based on measuring lung nodule volume and volume doubling time (VDT) is more specific for early lung cancer detection than a diameter-based protocol. However, whether this also applies to a Chinese population is unclear. The aim of this study is to compare the diagnostic performance of a volume-based protocol with a diameter-based protocol for lung cancer detection and optimize the nodule management criteria for a Chinese population.

In this population-based study, participants will undergo a low-dose chest CT scan for two rounds. At baseline, the first CT scan will be performed in all participants and their data will be collected. One-year after the baseline, a second CT scan will be performed and data will be collected again. CT images of each participant will be read twice independently by two groups of readers after the baseline and 1-year follow-up scans. In the first reading, the detected lung nodules are evaluated for diameter and managed according to a routine diameter-based protocol. The clinical management of participants are based on the first reading. In the second reading, each scan will be interpreted again by radiologists, blinded to the first reading. Semi-automated volumetry software will be used. The lung nodules will be evaluated for volume and management will be simulated according to a European volume-based protocol. Participants will be followed up and any diagnosis of lung cancer and related information will be collected at the fourth year through the hospital information system and by contacting the participants or their relatives.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40-74 years;
* Resident in the Hexi district of Tianjin city for at least 3 years;
* Having no self-reported history of any malignant tumor.

Exclusion Criteria:

* Pregnant woman will be excluded.
Botulinum Toxin for Carpal Tunnel Syndrome

To compare local steroid injections to local Botulinum toxin A injection in a double-blinded study.

To compare local steroid injections to local Botulinum toxin A injection in a double-blinded study. The goal is to investigate if Botulinum toxin A injections are effective for Carpal Tunnel Syndrome compared to steroid injections in terms of pain relief and length of symptom alleviation.

Eligibility Criteria:
Inclusion Criteria:

* Any individual with symptoms of carpal tunnel syndrome and a diagnosis of CTS either clinically or via EMG will be included into this study. There will be a total of 20 subjects displaying symptoms of CTS. The gender of the subjects will not determine enrollment. There is no requirement of male to female ratio for this study. There is no age cut-off or minimal age requirement to enroll in the study. No specific Racial or ethnic restrictions will be present for this study. Female subjects of childbearing potential (not surgically sterile or postmenopausal for at least 2 years) must have a negative pregnancy test at screening.

Exclusion Criteria:

1. Any individual who has a diagnosis of CTS (by EMG or other means) but no symptoms of CTS will be excluded from this study.
2. Vulnerable subjects as defined as children, pregnant women, those with limited autonomy, decisional incapacity and prisoners will not be enrolled in this study.
3. Individuals with any history of carpal tunnel release surgery and recurrent or persistent symptoms will be excluded form this study.
4. Subject is pregnant or lactating.
Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand

The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of inflammatory erosive osteoarthritis of the hand.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hand osteoarthritis
* Joint tenderness and/or redness
* At least one erosion by X-ray (as determined by the central reader)
* Contraceptive measures adequate to prevent pregnancy during the study

Exclusion Criteria:

* History of inflammatory disease other than hand EOA including: secondary post-traumatic OA; rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia
* History of gout, pseudogout, or hemochromatosis
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of recurrent or chronic systemic infections
* Known allergy to acetaminophen
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply
Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar

Thirty seven percent of adult male population smoke cigarettes in Qatar. The Global Youth Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar smoke cigarettes. Smoking cessation is a key to reducing smoking related diseases and deaths. Health care providers are in an ideal position to encourage smoking cessation. Pharmacists are the most accessible health care providers and are uniquely situated to initiate behavior change among patients. Many western studies have shown that pharmacists can be successful in helping patients quit smoking. Studies demonstrating the effectiveness of pharmacist delivered smoking cessation programs are lacking in Qatar. This proposal aims to test the effect of a structured smoking cessation program delivered by trained ambulatory pharmacists in Qatar. A prospective, randomized, controlled trial will be conducted at 8 ambulatory pharmacies in Qatar. Participants will be randomly assigned to receive a 4-session face-to-face structured patient-specific smoking cessation program conducted by the pharmacist or 5 to 10 minutes of unstructured brief smoking cessation advice given by the pharmacist. Both groups will be offered nicotine therapy if feasible. The primary outcome of smoking cessation will be confirmed by exhaled carbon monoxide test at 12 months. If proven to be effective, this smoking cessation program will be considered as a model that Qatar and the region can apply to decrease smoking burden.


Eligibility Criteria:
Eligible participants are:

* patients aged 18 years and older who currently smoke one or more cigarettes daily for 7 days, are motivated to quit i.e.: in the preparation stage of the stage-of-change model, able to communicate in Arabic or English and are willing and capable of attending the scheduled sessions at the study pharmacies.

Exclusion criteria are:

* use of other nicotine or tobacco products
* current use or use in the last 30 days of quit smoking aids or medications
* plan to leave Qatar in the next 12 months
* presence of any major medical condition that would prevent use of the nicotine replacement therapy including hypersensitivity to the products, history of or recent myocardial infarction, life-threatening arrhythmias, severe or worsening angina, uncontrolled hypertension and temporomandibular joint disease (in case of nicotine gum)
* pregnancy
* psychiatric illness or other debilitating condition that would interfere with participation in the study.