cyrilzakka/clinical-trials huggingface dataset:
Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy

Nowadays, TRUS biopsy become one of the most popular tests for diagnosis of prostate cancer. This procedure causes pain to the patients who does not received the sedative drugs or analgesic drugs. There are many ways to reduce pain and inconvenience for the patients, such as intravenous propofol, intravenous fentanyl etc. In Siriraj hospital, anesthesiologists usually give intravenous propofol with intravenous opioids but the visual analogue score after this procedure was average at 0.9-2.9. Furthermore, some systematic reviews have shown that there was no difference in pain score between periprostatic nerve block plus opioid and periprostatic nerve block only. So, this study is to find out whether opioids is need for TRUS biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 year
* Patient American society of anesthesiology physical status I-III.
* Scheduled for Transrectal ultrasound-guided prostate biopsy
* BMI equal to or less than 30 kg/cm2

Exclusion Criteria:

* Known hypersensitivity to propofol or fentanyl
* History of bleeding tendency
* Known case of active anal or rectal disease
* Unable to rate pain score
* History of drug abuse
* Chronic opioid use
War Impact on the Final Year Ukrainian Resident's Competence Acquisition

The study to identify the war impact on the second (final) year residents-anaesthesiologists' education quality and their ability to get necessary competencies.

The study was conducted at the postgraduate surgery, anesthesiology and intensive care department of Bogomolets National Medical University (Bogomolets NMU).

It started before the war to assess the education quality and residents-anesthesiologists readiness for independent work after two years of residency. When the war started, the study was continued and then results 2021 compared against 2022.

In Ukraine we have a 2-year residency program in anaesthesiology and intensive care, it includes 12 months of a so-called theoretical part, which is provided by postgraduate faculties with rotation on different clinical departments of the faculty (like obstetric anaesthesiology, cardio anaesthesiology, intensive care, transplantology, thoracic anesthesiology etc.), and 10 months of practical part - in one of the major acute hospitals. When Russia invaded Ukraine, 41 final-year residents were studying at the postgraduate department of surgery, anesthesiology and intensive care at Bogomolets NMU. From the 5th day of the war education program was changed to online-based, including an interactive platform for distance learning, ZOOM-meeting for lectures and seminars, and individual work with teachers through online messengers and video calls. 30 (73%) residents and 3 (20%) teachers left Kyiv for 1,5-2 months due to the direct attack of the artillery, missile and troops, with occupied and destroyed Kyiv suburbs, where part of them was living. Those residents, who have left Kyiv, were distributed to hospitals in the Western part of Ukraine to continue their practice in anesthesiology and intensive care departments. Residents, who stayed in Kyiv, were distributed to trauma and military hospitals, which had a lot of patients due to the ongoing war in the city.

After Ukrainian counter offences and Russian withdrawal from the Kyiv district, most of the residents (39) and all teachers came back in April 2022. As a result, live practical sessions and master classes were restored to overtake the program, although we continued online learning with lectures, seminars and other activities.

On the 22nd of June, all residents had an OSCE exam. After passing the OSCE exam, investigators send questionaries' to all residents to reflect on the education quality, competence acquisition and readiness to work as an independent anesthesiologist.

Other questionaries' were sent to all teachers to assess the educational outcomes and war impact, efficacy of the different types of learning and reflection on what needs to be improved.

Eligibility Criteria:
Inclusion Criteria:

* residents-anesthesiologists of the second year

Exclusion Criteria:

* residents-anesthesiologists, who didn't pass final exams
Building Collaborations to Address Drug Problems in the United States and China

The purpose of this study is to evaluate the impact of a Cognitive Behavioral Therapy (CBT) intervention on the distribution and variability of pain level before and after intervention receipt among people with co-occurring chronic pain and Substance Use Disorders (SUDs) over a three-month follow-up period.

The project is an open trial of the CBT intervention for 20 adults receiving detoxification treatment with comorbid pain. Participants will be screened for pain and other conditions by completing a self-report survey questionnaire. Eligible participants will be asked to complete a baseline assessment. A trained research therapist will conduct individual therapy with participants twice a week for 2-4 weeks. Participants will be re-assessed at 1- and 3-month post-intervention follow-ups to track changes in their pain, functioning, and substance use.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Currently receiving detoxification treatment
* Report pain of at least moderate or greater intensity over the three months prior to baseline assessment as indicated by an average score of four or greater on the Numeric Rating Scale (NRS)
* Have access to a phone for confidential personal therapy after the completion of detoxification treatment. For individuals who enter the residential treatment at the facility following the detoxification treatment, a research therapist will meet with them in person at a private office at the facility during their stay due to program's restriction on phone usage.

Exclusion Criteria:

* Inability to speak and understand English
* Inability to give informed, voluntary, written consent
Treatment Use of 3,4-Diaminopyridine

This protocol provided 3,4 diaminopyridine (DAP) under a treatment-use IND to patients with congenital myasthenic syndrome (CMS). It is now closed.

CMS diagnoses were made based on clinical, electrophysiologic and molecular genetic findings. All patients were referred to the PI for DAP treatment. This study enrolled minors and adults.

CMS patients under age 18 years were included if their parent or guardian gave written permission. Minors who turned 18 while in the program were re-consented as adults.

The dose of DAP was determined individually for each patient. Adults were started with a dose of 10 mg 3-4 times daily, increased over several weeks to the dose that produced the maximum symptomatic response, not to exceed 100 mg daily. Pyridostigmine bromide (PB) was often added at low doses and increased to the dose that produced the best response, not to exceed 360 mg daily. In children, equivalent doses of these medications were calculated on a surface area basis. The doses of DAP and PB were periodically adjusted to assure that the smallest effective doses are used.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of congenital myasthenic syndrome (CMS)
* Women of childbearing potential must have negative pregnancy test and agree to practice adequate contraception while taking DAP
* Must be competent to give consent

Exclusion Criteria:

* Known seizure disorder
* Pregnancy
* Known cardiac arrhythmia or evidence of significant arrhythmia on screening ECG
* Known hepatic, renal or hematologic disease
Post-Market Clinical Follow-Up onTVT EXACT® Continence System

The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).


Eligibility Criteria:
Inclusion Criteria:

Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:

1. Stress urinary incontinence symptoms
2. Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test
3. Female subjects ≥ 21 years of age requiring treatment of SUI
4. Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling
5. Planned surgery for primary stress incontinence without concomitant prolapse surgery
6. Patient able and willing to participate in follow-up
7. Subject or authorized representative has signed the approved informed consent

Exclusion Criteria:

Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:

1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits and are unable to complete the questionnaires
2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
3. History of previous synthetic, biologic or fascial pubo-urethral sling
4. Pregnancy or plans for future pregnancy
5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.
6. Current genitourinary fistula or urethral diverticulum
7. Reversible cause of incontinence (i.e. drug effect)
8. Contraindication to surgery
Comparison of Hybrid and Bismuth Quadruple Therapies for Helicobacter Pylori Eradication

According the Maastricht IV consensus report publish in the Gut 2012, bismuth containing quadruple therapy was suggested to be the first choice for eradication therapy of Helicobacter pylori in the area with high clarithromycin resistance. Whether hybrid therapy or 14-day bismuth containing quadruple therapy can replace standard triple therapy as the recommended first-line treatment is unknown. The investigators compared the efficacy of 14-day hybrid therapy and 14-day bismuth containing quadruple therapy in first-line treatment.

For this randomly assigned to receive either a 14-day hybrid therapy (a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days) or a 14-day bismuth containing quadruple therapies (pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days).at a 1:1 ratio. Our primary outcomes was the eradication rate by intention-to-treat and per- protocol analyses

Eligibility Criteria:
Inclusion Criteria:

* Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

* previous H pylori-eradication therapy
* ingestion of antibiotics or bismuth within the prior 4 weeks
* patients with allergic history to the medications used
* patients with previous gastric surgery
* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
* pregnant women
"Effect of Screening Using Imaging (CT/ EUS) on Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With New Onset Diabetes (NOD)" - A Prospective Pilot Observational Study

To assess whether EUS (Endoscopic Ultrasound) can serve as a valuable diagnostic tool for identifying PDAC at an early stage in individuals who have recently been diagnosed with diabetes.

Purpose: To improve the rates of early detection of pancreatic cancer.

Pancreatic ductal adenocarcinoma (PDAC) is a type of cancer that starts in the pancreas, a gland located in your abdomen. It happens when some cells in the pancreas start growing abnormally and form a cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Patients diagnosed with diabetes based on FBS/ PPBS/ HbA1C
* Presence of atleast 1 FBS parameter measured in the past 6-18 months which was not \> 125 mg/dl
* END-PDAC score \> 2

Exclusion Criteria:

* Known or newly detected chronic pancreatitis
* Past history of pancreatic cancer
* History of steroid use
* Contraindications for EUS
PICC Asymptomatic Thrombosis Study: A Pilot Study

The study purpose is to perform a preliminary, comparative evaluation of the Hydrophilic Biomaterial technology to confirm the performance of the catheter, by using UltraSound technology in-vivo.

This study will compare two different materials to evaluate asymptomatic thrombosis using ultrasound technology.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is indicated for a medically necessary PICC for therapeutic delivery medication
2. Patient is eligible to receive a single lumen PICC
3. Patient is an adult who is prescribed a PICC line
4. Patient's expected duration of treatment requiring a PICC for a minimum of 16 days post device implantation
5. Patient understands and is willing to comply with all study requirements and has voluntarily signed the Informed Consent Form (ICF).

Exclusion Criteria:

1. Is pregnant, lactating, or is planning to become pregnant during the time of the study
2. Has been previously enrolled in this post market clinical evaluation, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation
3. Venous thrombosis in any portion of the vein to be catheterized
4. Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
5. Orthopedic or neurological conditions affecting the extremity
6. Anticipation or presence of dialysis grafts or other intraluminal devices, including pacemakers, within a month of patient enrollment start
7. Patients who are on anticoagulation therapy prior to the study (10-14 days). Note: (If patients are placed on anticoagulation (low dose) therapy while hospitalized, these patients are allowed.)
8. Patient has relinquished control of care to a guardian and/or facility
9. Patient has any significant medical or physical condition that, in the opinion of the PI, would make the subject unsuitable for participation in the post market clinical evaluation
10. Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for Infraorbital Neuralgia

This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of PRP injections combined with PRF treatment with PRF alone in patients with IONa who are responded poorly to conventional therapies and are reluctant to receive destructive therapies for seeking a better minimally invasive treatment strategy.

Infraorbital neuralgia (IONa) is one of a rare but devastating type of facial pain and lack of current consensus on the management. Previously, we have proved the efficacy of pulsed radiofrequency (PRF) in treatment of IONa. However, refractory patients have not received more ideal treatment until now. Platelet-rich plasma (PRP), as supraphysiological concentration of platelets, can provide prolonged neuropathic pain relief with almost no complications. To date, the efficacy of PRP combined with PRF in the treatment of IONa has not yet been proved. We will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of PRP combined with PRF in treating refractory IONa patients who were reluctant to receive destructive therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 75 years;
2. Paroxysmal or persistent stabbing pain in the distribution area of the infraorbital nerve and positive response to diagnostic block (1 ml of 2% lidocaine) prior to treatment;
3. NRS score≥7;
4. Scheduled for PRF treatment for IONa；
5. Signed informed consent.

Exclusion Criteria:

1. Platelet count \<105\*109/L, ongoing anticoagulation therapy or antiplatelets treatment, coagulation disorders or bleeding disorders;
2. Severe cardiopulmonary or hepatorenal dysfunction;
3. Infection at the puncture site; .
4. Neuralgia secondary to tissue damage around the infraorbital foramen from causes such as maxillary sinusitis or tumor;
5. History of destructive treatments such as radiofrequency thermocoagulation, chemical ablation, infraorbital neurectomy, infraorbital nerve avulsion, etc;
6. History of mental disorders；
7. History of narcotic drug abuse;
8. Unable to cooperation.
A Survey To Elicit The Relationship Between Literacy And Glycemic Control In Pediatric Diabetes

The purpose of this study is to see if a patient's ability (and/ or parent) to read, write, and do basic math problems affects blood sugar control in children with type 1 diabetes mellitus.

"Literacy" is defined as an individual's ability to read, write, and speak English, and compute and solve problems at levels of proficiency necessary to function on the job and in society, to achieve one's goals, and develop one's knowledge and potential, according to the National Literacy Act of 1991. The National Work Group on Health and Literacy reported that between 40 and 44 million persons in the United States have rudimentary literacy skills, and are unable to understand written materials that require only basic reading proficiency. Illiteracy has become an increasingly important problem, especially as it relates to healthcare. Literacy skills are paramount to effective self-management of type 1 and type 2 diabetes mellitus. And, "Diabetes Self-Management Education" is the cornerstone of care for all individuals with diabetes who want to achieve successful health-related outcomes. Self care of diabetes plays a major role in achieving DCCT recommended level of hemoglobin A1C. Deficient self-management will lead to uncontrolled diabetes, resulting in multisystem complications, increasing exponentially the burden on our healthcare system. Structured education of individuals tailored to combat poor literacy skills is imperative in helping these individuals achieve good glycemic control. Hence we would like to evaluate literacy in our clinic so appropriate educational material can be developed to help patient with T1DM who have low literacy.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus
* Parent/ legal guardian must be present if child is less than 18 years of age.
* Diagnosis of type 1 or type 2 diabetes mellitus must have been made at least 1 year earlier.
* Parent/ legal guardian and/ or child must have completed all 3 mandatory diabetes education classes.
* English and/or Spanish speaking only.

Exclusion Criteria:

* Any form of mental retardation or cognitive disorder in parent/ legal guardian.
* Mental retardation or cognitive disorder in a child who is in Grade 6 or higher.
To Compare the Safety and Efficacy of Balloon Occluded/Plug Assisted Retrograde Transvenous Obliteration With Endoscopic Variceal Obturation for Primary Prophylaxis of Gastric Varices With Large Spontaneous Shunt

Study population: All the consecutive patients of cirrhosis who are diagnosed to have large gastric varices without prior history of bleeding from GV, who came to OPD or endoscopy in Hepatology department of ILBS will be evaluated for inclusion.

Study design: Prospective interventional study. The study will be conducted in the Department of Hepatology ILBS.

Study period: 1.0 years

Sample size: 42


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years
2. Cirrhotic patients, with GV (GOV2 or IGV1) with eradicated or small low risk esophageal varices with gastrorenal shunt of \>10 mm size amenable for BRTO/PARTO.

Exclusion Criteria:

1. Non-cirrhotic portal hypertension,
2. History of bleeding from GV
3. Hepatic encephalopathy grade III/IV,
4. Acute kidney injury
5. Patients on beta blocker therapy for \> 6 months prior to enrollment in study
6. Hepatocellular carcinoma
7. Portal venous thrombosis
8. Presence of jaundice (bilirubin \>3 mg/dl), ascites, Child C, MELD \> 18
9. Advanced cardiac or pulmonary diseases
10. Pregnancy
11. Patients not giving informed consent
Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6

Evaluation of preference for three female condoms (FC).

The primary goal of this study was to identify the female condom most preferred by study participants. This provided USAID with data to make informed decisions regarding female condom purchases. The study was conducted in three parts. The objective of Part 1 was to familiarize each participant with the three FC types, to minimize learning curve effect in subsequent phases of study, and to gather information on participant demographics, FC acceptability, device function, safety, preference for each of the condom types, and use of male condoms during the same time period. The objective of Part 2 was to determine actual, "unstated" and "unbiased" preference for a particular type of FC. The objective of Part 3 was to identify reasons for preference of a particular FC type and to document details surrounding product use/non-use.

Eligibility Criteria:
Inclusion Criteria:

* All women enrolled in this research must meet the following selection criteria:

  1. must be at least 18 years of age.
  2. must be literate (able to read a newspaper or letter easily).
  3. must be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrollment).
  4. must be in an exclusive (monogamous) sexual relationship with her spouse or partner while participating in this research study.
  5. must have been in a sexual relationship with this partner for at least 6 months.
  6. must be without evidence of STI as determined through syndromic diagnosis and vaginal examination.
  7. must be on hormonal or other non-barrier contraception (e.g. OCs, injectables, IUD, or have had a tubal sterilization or be post-menopausal-defined as 12 months with no period).
  8. must be willing to give informed consent.
  9. must be able to complete condom use log.
  10. must be willing to use the study condoms as directed.
  11. must be willing to adhere to the follow-up schedule and all study procedures.
  12. must have successfully completed a given phase of study before advancing into subsequent phases (e.g. successfully completing Part 1 before advancing to Part 2, etc.).
  13. must be willing to provide research study staff with an address, phone number or other locator information while participating in the study.
  14. must be willing to participate in the study for up to six months.
* Exclusion Criteria:

  1. must not be a sex worker.
  2. must not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study.
  3. must not be breastfeeding.
  4. must not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms.
Validity And Reliability Of The Short Physical Performance Battery In Patients Undergoing Total Knee Arthroplasty

Objectives: Practical, applicable, valid, and reliable tools are needed to assess physical performance in patients with Total Knee Arthroplasty(TKA) in a variety of settings, including routine clinical assessment, research studies, and community-based programs. Therefore, the aim of this study is to evaluate the validity and reliability of the Short Physical Performance Battery (SPPB) among patients with TKA.

Methods: We included patients who underwent TKA surgery. The SPPB, Timed up and go(TUG) test and, Hospital for Special Surgery (HSS) Knee Score were administered to the patients. SPPB was performed twice on the same day with 1 h rest.


Eligibility Criteria:
Inclusion Criteria:

* patients who had primary TKA surgery at six months ago, were diagnosed with preoperative knee OA, and were willing to participate in the research

Exclusion Criteria:

* a previous orthopedic, neurological, or systemic disease that effected walking or standing, body mass index of 40 kg / m2 and over and having any other surgery on the same limb that effected walking.