cyrilzakka/clinical-trials huggingface dataset:
Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years

Over the past 5-7 years there has been increasing concern about the use of polypropylene tapes in female incontinence surgery. There has been a special focus on pain in the vagina and lower abdomen and pain during sexual intercourse. Some have also asked if the polypropylene tape could cause impairment of the immune system leading to allergy, connective tissue disorders etc. There are still only a few publications on complications after sling surgery.

In Norway it is mandatory to register all incontinence surgery in the National incontinence registry (Norsk Kvinnelig Inkontinens Register (NKIR). In 2019 \>99 % of all procedures were registered in this registry. Data about type and severity of incontinence are registered, as well as complications at surgery. The same data are entered at a 6 months and 3 years follow up. Data for the follow up visits are not complete. The NKIR registry and other similar registries have been criticized for not following the women long enough and therefore missing important information regarding long-term complications. Few studies have followed the women for a longer time after surgery. The main aim of this study is to find the prevalence of women still satisfied with the TVT surgery and the prevalence of long-term complications after 10 and 20 years.


Eligibility Criteria:
Inclusion Criteria:

* had TVT surgery in Norway January 2001-December 2002 (20-years follow-up cohort)
* had TVT surgery in Norway, \< 42 years at the time of surgery in 2011-2012 (10-years follow-up cohort)

Exclusion Criteria:

* Dead
* Not willing to participate
* Moved out of Norway
Dexmedetomidine Improves the Surgical Field and Postoperative Recovery of Nasal Endoscopic Surgery

Studies showed dexmedetomidine (DEX) could improve surgical field, but the effect for functional nasal endoscopic surgery (FESS) was unclear. The investigators explored IV administration of a single loading dose DEX (0.5μg/kg) for FESS, and IV administration of midazolam (0.05mg/kg) as a control with comparision of surgical field, haemodynamics, ventilation parameters and recovery.

The participants received an induction of anesthesia with propofol 2-3 mg/kg, sufentanyl 0.2 μg/kg, and rocuronium 0.6 mg/kg, and then insertion of a flexible laryngeal mask airway was conducted using the index finger insertion technique by anesthesia providers with a minimum of four years endotracheal intubation experience. Mechanical ventilation parameters were as follows: pressure-controlled ventilation mode, ventilation pressure: 12, respiratory rate: 12, oxygen concentration: 50%. The maintenance of general anesthesia was performed with sevoflurane at minimum alveolar concentration of 1.3. After induction, a single loading dose DEX (0.5μg/kg) was IV infusion within 10 minutes, or IV administration of midazolam (0.05mg/kg). Heart rate, blood pressure, tidal volume, ventilation pressure and ETCO2 after insertion of a LMA, 10 minutes, 20 minutes, 30 minutes after drug infusion and transferred to PACU, besides heart rate and blood pressure were recorded before and after induction. Surgical field was evaluated at the time of 10 minutes and 20 minutes after drug infusion. Blood gas analysis was performed just transferred to PACU and before transferred to ward.

Eligibility Criteria:
Inclusion Criteria:

* 120 participants who diagnosed with nasosinusitis
* The participants need undergo functional nasal endoscopic surgery
* The participants signed the informed consent

Exclusion Criteria:

* The participants were excluded with any diseases about respiration, circulation, liver and kidney
* The participants were rejected of the consent
A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain

This is an 11-week randomized, double-blind, placebo-controlled trial of Milnacipran 100 mg/d in patients with idiopathic neuropathic pain. Milnacipran, a dual norepinephrine and serotonin reuptake inhibitor has been a safe and beneficial treatment for patients with fibromyalgia and may be useful to treat patients with painful peripheral neuropathy.

The primary outcome will be assessed by the change in daily averaged weekly 0-10 pain intensity score, from baseline to week 9, by intention to treat analysis. The same analysis will be used on several secondary measures including daily averaged weekly 0-10 pain intensity score the sleep interference scale and the Rand-36 quality of life scale.

Milnacipran helps serotonin and noradrenaline work more effectively on the central nervous system. Serotonin and noradrenaline are molecules made by the brain that affect how your body responds to pain. Milnacipran, a dual norepinephrine and serotonin reuptake inhibitor has been a safe and beneficial treatment for patients with fibromyalgia and may be useful to treat patients with painful peripheral neuropathy. Many clinical trials for neuropathy pain are done in patients with diabetic neuropathy. Idiopathic neuropathy however, is a common cause of neuropathy and accounts for 25% of all neuropathies, and over 50% of small fiber neuropathies. The information in this study will provide information on whether milnacipran also provide benefit as a medication for neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 18 to 80 years
* Patients with signs and symptoms of a peripheral neuropathy, with either abnormal nerve conductions or abnormal epidermal nerve fiber density with neuropathic pain.
* Pain will have been present for at least 6 months
* Patients may be on other medications for neuropathic pain (eg, antiepileptic medications, opiates or non steroidal antiinflammatories); however they must be on a stable dose for 4 weeks prior to, with no plan to change during the study
* All patients must have had a normal fasting glucose or B12, thyroid stimulating hormone, and serum protein electrophoresis, since the onset of their symptoms.

Exclusion Criteria:

* Other cause of neuropathy (eg, diabetic neuropathy, toxic neuropathy, HIV neuropathy, celiac neuropathy, inherited neuropathy)
* Unstable angina
* Use of another serotonin and norepinephrine reuptake inhibitors (eg, duloxetine, venlafaxine), tricyclic antidepressants, monoamine oxidase inhibitors (MAOI) or selective serotonin reuptake inhibitors
* Myocardial infarction stroke or life threatening arrhythmia within the last 6 months
* HIV infection
* Hepatic or renal failure
* Pregnancy
* narrow angle glaucoma
* History of epilepsy or a seizure
Music Therapy Experiences in Patients With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)

This study compares different music therapy (MT) experiences and their impact on memory and language in patients with Alzheimer's disease and Mild Cognitive Impairment.

The 12-month study will assess the role of common experiences involving familiar music and other pleasant events (blinded control) to benefit cognition and measure the quality of life for people with Alzheimer's disease and Mild Cognitive Impairment.

Following screening, all participants will meet with a licensed music therapist at the first study visit. Thereafter, each group will have an individualized schedule of follow-up telephone calls and visits.

Screening for the study and participation in the study intervention can be completed in-person or from your home, if you do not live in the area.

Interested participants and their study partner will be enrolled after an evaluation to determine cognitive impairment or mild dementia. The evaluation, either in person or remote, will include cognitive testing, clinical and neurological evaluation, a review medical records and medical history and an examination as deemed necessary by a dementia physician. Eligible participants will undergo baseline testing including linguistic analyses and will be randomly assigned to one of 3 intervention groups. Participants and their study partners will be contacted at least once every three months for cognitive testing and medical review. Contact with the music therapy team will occur up to twice per week but not less than once per month, for the first six months study enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alzheimer's disease or mild cognitive impairment
* Must have study partner
* English speaking
* No verbal impairment
* Community-dwelling
* Must have webcam or smart phone

Exclusion Criteria:

* A diagnosis of dementia other than probable or possible AD
* Probable AD with Down syndrome
* History of a clinically significant stroke with residual deficit
* Current evidence or history in past two years of epilepsy, focal brain lesion, head injury
* Current diagnosis for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
* Participation in another interventional study
* Comorbidity causing disability interfering with intervention such as pain or discomfort or life expectancy less than 1 year
Evaluation of the PrePex Device for Rapid Scale-up of VMMC, Phase 3 Field Implementation Trial With HIV + Adult Males

This study will assess the safety of the PrePex device as applied to HIV positive men by assessing the rate of clinical adverse events. The study will include adult, HIV + men who are eligible to receive the PrePex procedure per the Zimbabwe Ministry of Health and Child Care (MOHCC) eligibility criteria.

According to mathematical modeling, Voluntary Medical Male Circumcision (VMMC) has the potential to have a major impact on reducing HIV incidence in areas with high HIV prevalence and low prevalence of male circumcision, as is the case in Zimbabwe. Male circumcision devices have the potential to accelerate VMMC scale-up as the procedure is faster and simpler and can be safely performed by nurses. However, fear of social stigma and desire to avoid HIV testing remain potential barriers to those HIV+ men who would otherwise seek out VMMC. Study subjects (n=400) are HIV+ males who elect to undergo VMMC with PrePex as a study subject, and healthcare workers involved in implementation of PrePex on HIV+ male subjects. The aim of the study is to determine if PrePex can be used safely among HIV+ men with similar rates of adverse events to HIV-uninfected men. If so, then the barrier of mandatory HIV testing as part of VMMC could be removed, encouraging more men to undergo the procedure. Determining PrePex safety in HIV+ men would also allow both those with unknown status and those with positive status to undergo MC with PrePex. Determining the barriers to performing VMMC among HIV+ men among healthcare workers, if any, would also inform future policy.

Eligibility Criteria:
Inclusion Criteria:

* Agrees to take an HIV test
* HIV sero-positive
* WHO HIV clinical stage 1 or 2
* Age 18 years and above
* Agrees to be circumcised by PrePex
* Able to understand the study procedures and requirements
* Completes VMMC counseling
* Agrees to return to the health care facility for follow-up visits or as instructed after this circumcision until complete healing 7 weeks from device application, or until cleared by a physician
* Able to comprehend and freely give informed consent for study participation

Exclusion Criteria:

* Known bleeding/coagulation abnormality (excessive bleeding from nosebleeds, pulled tooth, or gums)
* Uncontrolled diabetes (frequent treatment in a clinic or recent hospitalization for diabetes, frequent infections, hypertension, or kidney disease)
* Active genital infection, anatomic abnormality or any other condition, which in the opinion of the investigator prevents the subject from undergoing circumcision using PrePex.
* HIV sero-negative
* HIV status unknown
* WHO HIV stage 3 and above
* Does not agree to PrePex
Effectiveness of Large Language Model for Anaesthesia and Procedural Consent

Patient understanding of anaesthesia risks remains inconsistent due to time constraints, language barriers, and variable clinician communication styles. Traditional verbal consent may not consistently ensure comprehension or reduce preoperative anxiety. PEAR (Patient Education of Anesthesia Risks) is a multilingual, AI-driven chatbot developed to enhance patient education and improve the quality of anaesthesia risk counselling.

Study Objective:

To compare PEAR's performance in delivering anaesthesia risk consent against the standard face-to-face verbal method.

This study evaluates the effectiveness of PEAR (Patient Education of Anaesthesia Risks), a conversational AI-based chatbot designed to deliver anaesthesia risk education to patients in a personalized, interactive, and multilingual format. The goal is to support informed consent by improving patient comprehension, satisfaction, and reducing anxiety, while also streamlining clinician workflow.

Participants undergoing elective surgery will be randomly assigned to either receive anaesthesia counselling via PEAR before their consultation with the anaesthetist (intervention group) or undergo the standard face-to-face verbal consent process (control group). The PEAR chatbot is accessed through a secure digital interface and presents information aligned with institutional anaesthesia protocols.

The study will be conducted at hospitals within the SingHealth cluster in Singapore. Following the consent process, patients will complete a short quiz to assess understanding, a survey to evaluate satisfaction, and an anxiety scale. Clinicians will record time taken and perceived workload.

All patients will still meet their anaesthetist, ensuring clinical oversight is maintained. This study does not alter standard care but evaluates a digital adjunct to enhance it. Data will be collected electronically, anonymised, and stored securely. Insights from this trial may inform the wider implementation of digital tools in perioperative patient education.

Eligibility Criteria:
Inclusion Criteria:

- Adults (≥21 years old) undergoing elective surgery requiring anaesthesia

Classified as ASA Physical Status I to III

* Able to provide informed consent
* Able to communicate effectively in English, Chinese (Mandarin), Malay, or Tamil
* Willing and able to complete questionnaires and interact with the PEAR chatbot (intervention arm)

Exclusion Criteria:

* ASA Physical Status IV or above
* Cognitive impairment or psychiatric conditions that may limit comprehension or communication
* Non-literate patients or those unable to understand English, Chinese, Malay, or Tamil
* Emergency surgery cases
* Prior participation in the study (to prevent bias)
Deferred Stent Trial in STEMI

During primary PCI, stent deployment and post-dilatation are associated with no-reflow. The mechanisms for no reflow include distal embolization of thrombus, enhanced thrombus formation and vascular spasm. No reflow is associated with risk factors such as prolonged duration of ischaemia, heavy thrombus burden, persistent ST elevation and long stent length. ACTIVE HYPOTHESIS: once normal antegrade flow has been re-established with initial aspiration thrombectomy and/or balloon angioplasty at the beginning of primary PCI, compared with usual care with direct stenting, a strategy of deferred stenting for 4 -16 hours to permit the beneficial effects of normalized coronary blood flow and anti-thrombotic therapies will reduce the incidence of no reflow in at-risk STEMI patients. DESIGN: In consecutive STEMI patients with risk factors for no reflow and who have given informed consent, when normal flow has been established (TIMI 3) by initial aspiration thrombectomy and/or balloon angioplasty, participants will be randomized to deferred stenting or usual care with direct stenting. All patients will receive dual anti-platelet therapy. Patients who are randomized to deferred stenting will receive intravenous glycoprotein IIbIIIa inhibitor and anti-coagulation with low molecular weight heparin. Patients who are screened and not eligible to be randomized will be prospectively entered into a registry. Study assessments for feasibility, safety and efficacy will be prospectively performed. An independent clinical event committee will review all serious adverse events. Study endpoints will be subject to core laboratory analyses. The study is intended to inform the design of a larger multicentre clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Rescue PCI
* Prolonged ischaemic time (\> 12hours)
* Previous MI
* Age \> 65
* Occluded artery (TIMI 0/1) at initial angiography
* Thrombus burden (TIMI grade 2+)
* Long plaque/ stent length (\> 24 mm)
* Severe coronary artery disease (e.g calcified artery)
* Small reference vessel diameter (\< 2.5 mm)
* Persistent ST-elevation (\> 50%) following reperfusion
* Index of microvascular resistance (IMR) \> 40

Exclusion Criteria:

* Absence of normal coronary flow (TIMI 3)
The Canadian Respiratory Research Network Long COVID-19 Study

Preliminary studies suggest that COVID-19 causes long-term lung damage, even in young, otherwise healthy people who did not need to go to hospital or the ICU.

We seek to know how common long-term lung damage after COVID-19 is, who is most affected by it and what the effects of this damage are on other important aspects of people's lives. We plan to study a large sample of people with a history of COVID-19 infection from across Canada-some who needed hospitalization but most who did not. Through online questionnaires, we will determine their respiratory symptoms, quality of life and medical history. Then we will invite them to one of our thirteen Canadian testing centres to have special, thorough breathing tests.

We hypothesize that COVID-19 leaves a significant proportion of people with measurable respiratory impairment.

The information we learn about the effect of COVID-19 on the lungs will help patients and health care providers manage it better. It will also reveal how different COVID-19 variants affect the lungs. We will use this new knowledge to write a formal guide on what respiratory monitoring and testing should be done after COVID-19 infection. This will ensure that people affected by COVID-19 get the care they need to maintain their lung health.

We will prospectively recruit a representative, random sample of adult (age ≥ 18), community-dwelling patients, who have had a positive PCR test for COVID-19 infection and symptomatic infection five to 12 months previously.

This cross-sectional, observational study will have two phases:

1. Screening:

   Screening for eligibility
2. Observation Period:

   1. Online / telephone visit: All participants will complete a series of questionnaires (either online or by phone with the assistance of research personnel). In the questionnaires they will be asked about respiratory symptoms (the primary outcome), baseline participant data, burden of respiratory symptoms, overall quality of life, mental health issues as well as physical and psychological trauma from COVID-19.
   2. In-person visit: All participants will complete pulmonary function testing including oscillometry.

The study of COVID-19 infection and its long-term effects is constantly evolving. Over the course of this research study, new knowledge may become available that may lead to changes in the study's outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18
* Community dwelling
* First occurrence of a positive diagnostic test for SARS-CoV-2 infection (i.e., PCR or rapid antigen test, including at-home rapid antigen test) and symptomatic infection 5-12 months previously
* Consent provided
* Willing and able to go to study site for pulmonary function testing including oscillometry

Exclusion Criteria:

- Not able to communicate with our research personnel (themselves or through a translator)
The Effects of Mindsets on the Brain's Response to Food Cues

Previous studies have shown that obese individuals exhibit greater reward-related brain activity in response to food cues than lean individuals and our group has shown that successful weight loss maintainers who were previously obese and now maintain a healthy weight have increased control-related activity when viewing food cues. These findings suggest key roles for both reward-related brain areas and inhibitory control regions in eating behavior. However, no studies to date have examined (a) whether the response to food cues (i.e., cue-reactivity) can be changed in obese individuals, (b) which strategies are most effective at altering brain response to food cues, or (c) the neural mechanisms that support such change.

Given the omnipresent environmental cues to eat and the association between heightened reward-responsivity and obesity, it is critical to investigate ways to potentially alter food cue-reactivity in the obese. The most widely employed approach for behavioral weight loss treatment is Cognitive Behavioral Therapy (CBT), which incorporates strategies to control and change cognitions (e.g., avoid desire to eat tempting foods by focusing on something else). This approach is sometimes described as "change- focused" because modifying negative thoughts is assumed to thereby change associated maladaptive emotions and behaviors. Alternatively, emerging evidence suggests Acceptance and Commitment Therapy (ACT), which teaches participants to recognize and accept their cravings as feelings that need not be acted upon, may also be effective in treating obesity. A third strategy often employed in smoking cessation and substance abuse treatment is to focus on the long-term consequences of behaviors, however this form of treatment is not typically used in behavioral weight loss therapy. Thus although each approach is potentially effective, these treatment approaches differ greatly in the cognitive strategies they employ.

The primary aim of the proposed research is to compare a cognitive strategy used in CBT ('CHANGE'), a cognitive strategy emphasized in ACT ('ACCEPT'), and a cognitive strategy used in smoking cessation ('LATER') relative to a control condition ('NOW'), in their effectiveness in altering reward and inhibitory control responses to food cues among obese individuals.


Eligibility Criteria:
Inclusion Criteria:

* MRI compatibility
* 25-55 yrs old
* 25-40 BMI
* weight stable
* right handed

Exclusion Criteria:

* MRI incompatibility
* left handed