cyrilzakka/clinical-trials huggingface dataset:
Pain in Carpal Tunnel Release Wide-awake Local Anesthesia With no Tourniquet vs Local Anesthesia With Tourniquet

The aim of this study is to compare pain, satisfaction, and experience between patients who underwent Carpal Tunnel Release with wide-awake local anesthesia no tourniquet technique and local anesthesia with a tourniquet.

The surgical pathology of the hand has grown exponentially. In most cases, the resolution is performed in outpatients with short surgical times. Given the increased demand for this type of surgery, surgeons have sought different variables to reduce the costs and human resources. Thus, the wide-awake local anesthesia no tourniquet procedure (WALANT). It deals with the non-need for anesthetic monitoring and with the regional use of anesthesia with epinephrine.

Its use avoids placing a pneumatic cuff on the arm owing to the vasoconstrictive action of epinephrine. However, the drug takes 25-30 minutes to achieve the maximum hemostatic effect, and adverse effects, such as distal necrosis, have been reported.

Therefore, the technique of local anesthesia without epinephrine with a tourniquet (LA-T) is also used daily by hand surgeons.

The use of a tourniquet, a pneumatic cuff, for less than 20 minutes has been associated with the same or lower pain profiles than the wide-awake local anesthesia no tourniquet without running the risk of adverse effects of epinephrine.

The objective of this study is to compare and assess pain and patient experience after short-duration hand surgery using the WALANT and LA-T techniques. The investigators hypothesized that both types of procedures had a similar level of satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Carpal tunnel syndrome with surgical resolution
* Surgical procedures takes less than 30 minutes

Exclusion Criteria:

* Lost follow-up
PA Tolerability, Safety and Pharmacokinetics in Healthy Volunteers

This is a first-in-human (FIH) study to explore the safety, tolerability and pharmacokinetics of PA after oral ascending dose administration to healthy male volunteers.

The first-in-human dose (FHD) trial is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing safety, tolerability and pharmacokinetics (PK) of single and multiple oral doses of PA in healthy male subjects.

The study consists of two stages: single dose administration and multiple dose administration.

The single dose administration stage includes 5 cohorts, multiple dose administration stage includes at least 4 cohorts (groups). Each cohort includes 8 subjects (6 active drugs and 2 placebos). Cohorts intake ascending doses of study drug. The dose of 1st cohort is 1,0 mg/ml, the doses for the following cohorts will be estimated by the Data Monitoring Committee based on pharmacokinetics and safety results of previous group.

For each subject study includes screening period, one baseline period on Day -1, a treatment period (1 day - at single dose stage; 14 days - at multiple dose stage), followed by safety, PK, assessments up to 72-96 hours post dose. Follow-up visits will take place on Day 7 ; 30; 60 (single dose stage) and 30; 60; 90 (multiple dose stage).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 55 years
* Body mass index 16 to 30
* Subjects should be in good physical and mental health based on medical history, clinical examination and laboratory investigations
* Subjects should have signed informed consent prior to screening and the clinical study after they have read and understood the objective, conduct, risks related to the study, and their rights as study participants
* Subjects should have signed informed consent for being tested for HIV
* Subjects should have signed informed consent to be tested for alcoholemia, use of cannabinoids, cocaine, morphine, benzodiazepines, barbiturates and amphetamine

Exclusion Criteria:

* Subjects should not have evidence of any physical and/or mental health issues at screening and/or results of any clinical, laboratory and/or technical procedures at screening outside of the normal range
* Subjects should not be taking any concomitant medication
* Subjects should not have a history of allergies, hypersensitivity or intolerance to iodine or iodide or to medicines containing iodine such as contrast media used for radiologic examinations
* Subjects should not have a history of addiction or abuse of drugs or alcohol
* Subjects should not be in a position of subordination or other dependence on persons involved in the study such as sponsor, investigators, or any other person or institution interested in its results
* Subjects should not be members of the armed forces or prison inmates
* Subjects should not have positive serology for Hepatitis B, Hepatitis C or HIV
* Subjects should not have any apparent functional and/or physical defects which may or interfere with the study or distort results
Aphakia Versus Pseudophakia in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery

The purpose of this study is to document the safety and efficacy of primary IOL implantation in children below 2 years of age undergoing congenital cataract surgery.

The use of IOLs in pediatric patients has become increasingly popular in recent years and may represent a standard of care for older children. The refinements in surgical techniques attained in adult cataract surgery have been translated to pediatric cataract surgery to produce a technically safe eye. Nevertheless, the use of IOLs in children younger than 2 years remains controversial. Exaggerated inflammation, capsular opacification and changing refractive status of the developing eye should be considered before the use of IOLs in the first two years of life. Further more, there is concern about the unknown risks of an IOL over the long life span.

Currently, there are 3 methods of optical rehabilitation following congenital cataract surgery :

1. Primary IOL implantation.
2. Aphakic glasses.
3. Contact lenses.

At present, there is no randomized clinical trial reported to document the safety and efficacy of IOL implantation in children less than 2 years.

Aim : To compare the technical outcome (safety) and functional outcome (benefits) following primary IOL implantation and aphakia in children less than 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Children less than 2 years
* Congenital cataract
* Bilateral cataracts
* IOL fixation - Bag/Ciliary fixated

Exclusion Criteria:

* Microphthalmos (Mean axial length 2 SDs less than normal for age)
* Microcornea (Horizontal corneal diameter \<9.5 mm-asper that particular age)
* Iris coloboma
* PHPV
* Aniridia
* \*Glaucoma - IOP more than or equal to 25 mmHg

  * One eyed
  * Cataract surgery already performed in fellow eye
Multicentric Comparative Prospective Study of the Benefits and Risks of Biopsy Prostate Using Transrectal or Transperineal Procedure for the Prostate Cancer Diagnostic

The performance of prostatic biopsies is an essential element to confirm the diagnosis of prostate cancer and to specify the characteristics of the tumor in terms of stage and grade.

The first route of prostatic biopsies is mainly transrectal with passage of a needle introduced into the guide fixed on the endorectal ultrasound probe. There is another possible access route, transperineal, with prostatic puncture by a needle introduced transcutaneously, guided by an endorectal ultrasound image. The first transperineal route would offer the first benefit for the patient, to reduce the infectious risk inherent in the endorectal way. It would also reduce the risk of rectal bleeding.

In addition, the transperineal pathway appears to be able to improve the detection threshold of prostatic tumours located on the anterior part of the gland due to the angle of penetration of the needle and its more anterior positioning relative to the prostate.

There is currently no randomized comparison study of the transperineal versus transrectal procedure on infectious risk. The aim of the project is to enable this comparative study, within our institution where experienced urologist surgeons practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected prostate cancer with at least one of the following criteria met :

  1. MRI Staging: T2 or T3a,
  2. MRI Grading: Pirads greater than or equal to 3
  3. MRI tumor volume greater than or equal to 0.5 cm3

  e.Patient without tumor lesion detected by prostate MRI less than 3 months old with PSA \> 4 ng/ml, or an observed suspicious induration to the rectal exam
* Voluntarily signed and dated written informed consents prior to any study specific procedure,

Exclusion Criteria:

* Other medical conditions may interfere with the conduct of the study and, in the judgment of the investigator, would make the patient inappropriate for entry into this study,
* Individuals deprived of liberty or placed under legal guardianship,
* Unwillingness or inability to comply with the study protocol for any reason.
* Patients without a health insurance
Intraoperative Local Anaesthetic and Postoperative Pain

Background: Intraoperative wound infiltration with local anaesthetic is commonly used. Apart from the obvious immediate action it has been supported that a possible down regulation of pain receptors may lead to longer effects. Our aim was to compare the use of local anaesthetic versus placebo in order to assess if indeed there is a late beneficial effect.

Materials and methods: We will conduct a RCT involving 400 consecutive general surgery patients randomized in 2 groups: Group A= placebo, Group B= wound infiltration with ropivacaine 10%. We will record the preoperative and postoperative pain for the 1st week as well as the type and quantity of the analgesia used during the study period.

Hypothesis : patients who receive intraoperatively wound infiltration with local anaesthetic have lower pain during the 1st postoperative week and require less pain killers .


Eligibility Criteria:
Inclusion Criteria:

* Patients with conditions that require surgery ( general surgery)
* Must be able to comprehent the questions , fill documents, communicate well with the doctors
* Patients who will have at least one surgical incision under general or regional anaesthesia

Exclusion Criteria:

* Patients who could not comprehend well
* patients who remained intubated even for one postoperative day
* Patients who were discharged the day of the operation
TVT-SECUR as an Office-based Procedure

This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires.

This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 3 years.

The study will include 50 patients who would meet the inclusion/exclusion criteria and who sign the informed consent. Subjects are diagnosed with Stress urinary incontinence resulting from urethral hypermobility with no prior urinary incontinence surgery. Subjects are women who no longer intend to bear children and who do not require any other concomitant surgery.

Eligibility Criteria:
Inclusion Criteria:

* Stress urinary incontinence with hypermobility of the UV junction
* ASA I or II
* Age 21-89

Exclusion Criteria:

* Prior anti-incontinence surgery
* Not completed childbearing
* ASA III or higher
* Need concomitant surgery
* Poor compliance for office based approach
Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001

Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001

Provides up to six months treatment with CuATSM for subjects who have successffulyl completed study CMD-2019-001. \[This allows subjects randomized to placebo on study CMD-2019-001 to receive up to six months treatment with CuATSM and provides an up to an additional six months treatment with CuATSM for subjects randomized to CuATSM on study CMD-2019-001\]

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent prior to initiation of any study-specific procedures and treatment
* documented completion of protocol-specified assessments following completion of 24 weeks treatment on study CMD-2019-002
* Investigator considers patient has been tolerating treatment on study CMD-2019-001 and may benefit from continued treatment with CuATSM

Exclusion Criteria:

* not dependent on mechanical ventilation
Study to Learn More About the Effect of Itraconazole (ITZ) Given Repeatedly by Mouth on the Way How the Study Drug BAY1902607 Given One Time by Mouth Acts in the Human Body of Healthy Male Participants

BAY1902607 is a new type of drug under clinical development for different conditions including the treatment of endometriosis, i.e. a condition where the tissue that usually grows inside the womb grows outside of the womb.

Itraconazole (ITZ) is an approved drug often used for the treatment of fungal infections and possibly inhibits the breakdown of BAY1902607. In this clinical study, BAY1902607 is given alone by mouth or in combination with ITZ. Researchers want to learn more how quickly and to what extent the study drug BAY1902607 given by mouth to healthy male participants is absorbed by the human body, reaches the blood stream and is excreted again. In addition they want to find out whether the elimination of the study drug BAY1902607 is influenced by ITZ given at the same time.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, male adults
* Body mass index ≥ 18 and ≤ 30.0 kg/m²
* Body weight ≥ 50 kg

Exclusion Criteria:

* Known or suspected allergy or hypersensitivity to BAY1902607, itraconazole or any of their excipients
* Contraindications to itraconazole (symptoms or history of ventricular dysfunction, heart failure, liver disease).
* Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, within 1 week prior to the first drug administration or during the trial until follow-up (occasional use of ibuprofen is permissible). Particularly, this includes drugs that might affect the pharmacokinetics (PK) of BAY1902607, e.g. laxatives, loperamide, metoclopramide, antacids, H2-receptor antagonists, CYP3A4 inhibitors or inducers.
Internet and Telephone Counseling for Smoking Cessation

RATIONALE: Computer-assisted stop-smoking plans and telephone counseling may help people stop smoking. It is not yet known which computer-based smoking cessation program is more effective with or without telephone counseling in helping smokers quit smoking.

PURPOSE: This randomized clinical trial is studying two different computer-based smoking cessation programs to compare how well they work with or without telephone counseling in helping smokers quit smoking.

OBJECTIVES:

* Compare the efficacy of premium internet intervention vs premium internet with telephone intervention vs basic internet intervention, as determined by 7-day point prevalence abstinence at 12 months, in adult smokers.
* Compare the cost-effectiveness of these interventions in promoting smoking cessation.
* Determine the effects of internet-based interventions on measured use of the intervention (frequency and duration of use, utilization of behavioral coping, expert advices, and e-mail) in these patients.
* Determine the effects of internet-based interventions on variables important for behavior change including mediators (e.g., self-efficacy, use of internet social support) and moderators (e.g., gender, baseline motivation) of outcomes in these patients.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to gender and baseline motivation level. Patients are randomized to 1 of 3 intervention arms.

* Arm I (basic internet program): Patients are directed to a website of existing QuitNet™ smoking cessation materials. These materials are not tailored and have no interactive features.
* Arm II (premium internet program): Patients receive free 6-month access to the QuitNet™ website including interactive and individualized intervention features.
* Arm III (premium internet program plus telephone counseling): Patients receive free access to the QuitNet™ website as in arm II. Patients also receive up to 5 telephone counseling sessions, scheduled at their convenience.

All patients are assessed at baseline and then at 3, 6, 12, and 18 months.

PROJECTED ACCRUAL: A total of 2,205 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Smokes at least 5 cigarettes a day
* No prior use of QuitNet website
* Must have access to the internet and a telephone at home or work

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Combining Objective and Subjective Sedation Assessment Tools

The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation.

Patients in the intensive care unit (ICU) who require a ventilator to help them breathe also require sedation in order to keep them comfortable and prevent injury. The national guidelines for sedation management include a daily interruption of sedation performed once each morning. To determine the amount of sedation needed, the current standard practice is to use a system called the Richmond Agitation-Sedation Scale (RASS). The patient is stimulated by calling their name or by tapping their shoulder until the patient's responses indicate that a satisfactory level of sedation has been achieved.

The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the RASS will give better assessment of a subject's level of sedation. The BIS monitor is a sensor strip taped to the forehead and attached to a device that reads electrical activity from the brain. It is approved by the U.S. Food and Drug Administration (FDA) for monitoring patients under sedation.

Eligibility Criteria:
Inclusion Criteria:

* patient in the ICU
* continuous IV sedation with propofol midazolam or dexmedetomidine
* age \> 18
* expected to require mechanical ventilation for \>=48 hours

Exclusion Criteria:

* prisoners
* no available space on forehead
* continuous electroencephalography(EEG) monitoring
* bifrontal brain injury
* barbiturate coma therapy
* known hypersensitivity to study medications
* high risk for ethanol (ETOH) withdrawal
* resuscitation from cardiac arrest without recovery of mental status
* moribund clinical state (death expected within 48 hours)
Passive Heat Therapy for People With COPD

People with Chronic Obstructive Pulmonary Disease (COPD) often develop high blood pressure and heart disease due to their sedentary lifestyle and difficulty exercising. The investigators will test if heating can mimic the health benefits of exercise by monitoring the increase in leg blood-flow using ultrasound during a 45-minute hot-water footbath. The patients will then undergo 6-weeks of hot-water footbaths to examine whether the changes to blood-flow lead to improvements in blood pressure and other indicators of heart disease risk.

People with COPD are at higher risk of developing cardiovascular disease (CVD). While exercise training is a potent therapy for CVD, people with COPD have a low tolerance for exercise due to dyspnea and premature muscle fatigue. Thus, there is a need to develop more effective strategies to improve CVD risk in people with COPD. A novel way to reduce blood pressure and enhance arterial health is with passive heat therapy (PHT). An acute 45-min bout of lower limb hot-water immersion has been shown to increase leg blood flow and reduce blood pressure in healthy older adults, suggesting that PHT could have similar hypotensive and anti-atherosclerotic effects as exercise. Augmenting leg blood flow with PHT may also have functional benefits by reducing peripheral muscle fatigue and improving exercise tolerance. No study to date has looked at the acute and chronic hemodynamic and vascular responses to PHT in people with COPD, nor whether it can acutely or chronically improve exercise tolerance.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking individuals
* \>40 years of age
* Stable (exacerbation free for \>6 weeks), moderate-to-severe COPD (post bronchodilator FEV1/FVC \<lower limit of normal and FEV1 z-score \<2.51)

Exclusion Criteria:

* Performing structured exercise training (i.e. pulmonary rehabilitation)
* Have advanced cardiac or cerebrovascular disease (i.e. a history of heart failure, previous stroke or myocardial infarction)
* Have uncontrolled hypertension (\>160/95 mmHg at rest)
* Have hypotension (\<110/60 mmHg)
* Are taking Beta Blockers
* Regularly (\>1/week) have hot baths (\>30 min) or use a hot tub or sauna.

Exclusion Criteria for exercise outcomes:

* Have resting blood pressure \> 150/95 mmHg
* On supplemental oxygen for hypoxemia.
* Musculoskeletal pain that limits their ability to perform stationary cycling.