cyrilzakka/clinical-trials huggingface dataset:
Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

Diagnostic esophagogastroduodenoscopy is an uncomfortable and stressful procedure for most of the patients. Various methods are available for sedation during this procedure. Because of some side effects related to intravenous administration of sedatives, oral administration of these drugs is under attention. Alprazolam is a benzodiazepine which is used mainly in treatment of anxiety. Hence, we determine the efficacy of oral and sublingual alprazolam as for sedation during this procedure. We hypothesize that sublingual alprazolam is more effective than that oral form and both forms more effective than placebo in reducing anxiety and pain/discomfort related to the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Referring for upper GI endoscopy
* Age 18 to 65 years
* First experience of upper GI endoscopy
* Class I or II of American Anesthesiology Association
* Willingness to participate

Exclusion Criteria:

* Severe psychiatric, neurological, cardio-vascular, or renal disorders
* History of allergy or intolerance to benzodiazepines or lidocaine
* History of upper GI surgery
* Pregnancy or lactation
* GI anomalia during endoscopy
* Need for therapeutic procedures during endoscopy
* Active bleeding
Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial

The aim of this study is to compare two physical therapy training consisting of gait training that are distinguished by one being associated with tasks that require handling of the main executive functions, performed by individuals with Parkinson's Disease.

The investigators hypothesis is that the experimental group (EG), which hold gait training with higher cognitive demands (dual-task condition), will make improvements in the parameters measured (functionality of gait and cognitive ability) to a greater extent compared to the control group (CG), which hold gait training without executive tasks (single-task condition).

The aim of this study is to compare two physical therapy training consisting of a gait training that are distinguished by one being associated with tasks that require handling of the main executive functions (protocol designed by the same team), performed by individuals with Parkinson's Disease.

Both training consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, with the following difference:

* the experimental group (EG) will hold another 30 minutes of gait training in a dual-task condition associated with distracting tasks that require handling of the main executive functions;
* the control group (CG) will hold an additional 30 minutes of gait training without associated tasks.

It will be a prospective study, single blind, randomized, where 30 patients with PD in stages 1 to 3 on Hoehn \& Yahr scale will participate in the study, to be held in Brazil Parkinson Association. Patients will be randomized into an experimental and control group, 15 in each one.

The training will consist of 10 sessions, two times per week for five weeks. The executive tasks concomitant with gait training cover the following executive functions: volition, self-awareness, planning, response inhibition, response monitoring and attention.

The main outcome measures are: (1) Dynamic Gait Index (DGI), (2) Montreal Cognitive Assessment (MoCA), (3) Trail Making Test A and B, (4) Unified Parkinson's Disease Rating Scale (UPDRS) and (5) Falls Efficacy Scale (FES).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Idiopathic PD performed by a neurologist specialist in movement disorders;
* In use of dopaminergic medication;
* Disease severity of 1 to 3 according to Hoehn \& Yahr scale;
* Absence of other neurological disorders or co-morbidities that may affect gait;
* Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE);
* Vision and hearing adequate or corrected to normal;
* Ability to walk independently;
* Absence of prolonged off state;
* Age 50 to 85 years.

Exclusion Criteria:

* Biomechanical alterations (other pathologies) that could compromise the completion of training;
* Presence of depression, detected by the Geriatric Depression Scale (GDS-15);
* Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during gait training;
* Any changes in drug treatment for PD.
Effectiveness of Echogenic and Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block

In this prospective, randomized, double blinded study, the needle tip and needle shaft visibility of echogenic and nonechogenic needle were compared in ultrasound guided infraclavicular brachial plexus block. Sixty patients scheduled for upper extremity surgery were included in the study. Patients were randomised into two groups, group E (Echogenic) and group NE (Nonechogenic) with 30 subjects in each group. Under ultrasound guidance infraclavicular brachial plexus block was performed. In Group E, Pajunk Sonoplex echogenic needle was used and in Group NE, Stimuplex Braun nonechogenic needle was used. The subjective assessment for needle tip/shaft visibility as scored by the performer and the objective assessment from the recorded block procedure video were noted.

The aim of the investigators study was to find out the better among the echogenic and nonechogenic needle in needle tip/shaft visibility and the block success rate in ultrasound guided infraclavicular brachial plexus block. Sixty patients were randomized into two groups, Group E (echogenic group) and Group NE (nonechogenic group) with thirty patients in each group. The ultrasound imaging of each nerve block was video recorded for later analysis. Recording commenced from skin puncture and stopped at the time of final needle removal (total block time). After each block the performer was asked to subjectively score the percentage time he had visualized the needle tip and needle shaft on a 5 point scale (1 = 0%-20%, 2 = 20%-40%, 3 = 40%- 60%, 4 = 60%-80%, 5 = 80%-100%). The recorded video was later analysed by an investigator. An objective measurement of percentage needle tip visibility and needle shaft visibility was calculated for each nerve block using the formula,

Time in view (needle tip) / total block time x 100

Time in view (needle shaft) / total block time x 100

The subjective assessment for needle tip/shaft visibility as scored by the performer and the objective assessment from the recorded block procedure video were noted. Other block parameters were also compared.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years, both male and female scheduled for upper extremity surgery

Exclusion Criteria:

* Clinically significant coagulopathy
* Local anesthetic allergy
* Preexisting motor or sensory deficit in the operative limb
* Uncontrolled hypertension and unstable Ischemic Heart disease
* Body mass index \> 35
* Patients who needs general anaesthesia for surgery
Observational Study of Efficacy and Safety of Travogen Cream and Travocort Cream in the Treatment of Mycoses

An assessment of the efficacy and safety of Travogen cream and Travocort cream in the treatment of local skin mycoses


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of skin mycosis

Exclusion Criteria:

* Allergies to study medication
Effect of Inspiratory Muscle Training on Cardiopulmonary Capacity in Wheelchair Rugby Athletes

The goal of this clinical trial is to learn about in inspiratory muscle training on cardiorespiratory capacity, pulmonary function, respiratory muscle strength, sports skills, and quality of life of wheelchair rugby athletes. The main question\[s\] it aims to answer are:

* Are the wheelchair rugby athletes show better results in cardiopulmonary assessment tests in safety and effort, in the post- inspiratory muscle training period, when compared to their results in the pre-inspiratory muscle training period?
* Is inspiratory muscle training capable of increasing ventilatory capacity at rest and during exertion?

Participants will be evaluated through questionnaires, laboratory and field tests, such as:

* Pulmonary function (spirometry),
* Inspiratory muscle strength (manovacuometry),
* Cardiorespiratory capacity under exertion (cardiopulmonary exercise test),
* Wheelchair rugby specific skills (Beck Battery)
* Quality of life (WHOQOL-DIS) .

People with physical-motor disabilities, dependent on wheelchairs, have less mobility compared to people without disabilities, which can, in turn, have a direct and negative impact on the aerobic capacity and health of these individuals. Wheelchair Rugby (WCR) practitioners, as well as other sports, seek constant performance improvement, given the need to achieve better results in competitions. There has been an increase in the evaluation of parameters that may be related to better sports performance, as well as interventions that improve such performance. In relation to collective sports, such as WCR, the evaluation of important parameters such as maximum oxygen consumption during effort, maximum heart rate achieved and anaerobic limits, which enable adequate training adjustment, has gained prominence. Different interventions, such as inspiratory muscle training (IMT), aim to improve respiratory capacity and, consequently, cardiopulmonary capacity in savings and maximum effort. Therefore, this is a clinical study, with the objective of verifying the impact of IMT on cardiopulmonary performance, spirometric variables at rest and during effort, performance in field tests (Beck Battery) and quality of life in WCR athletes. Rugby athletes will be recruited in wheelchairs from teams in Rio de Janeiro, to perform two daily sessions of 30 forced inspirations followed by long, but not maximum, expirations, with a load adjusted between 50% and 60% of maximum inspiratory muscle strength, five times a week for six weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male gender,
* Age equal to or greater than 18 years,
* Presence of quadriplegia or tetra-equivalence,
* Wheelchair Rugby training time equal to or greater than six months,
* Participation in at least one official competition in the previous year the search.

Exclusion Criteria:

* The presence of musculoskeletal injury or pain that could interfere with the performance of movements in the wheelchair,
* Respiratory infections in the three weeks before the evaluations.
Evaluation of Comfort in Subjects With Moderate Dry Eye Disease

The purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. This study will be conducted in Canada and Australia.


Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an information consent letter
* Willing and able to follow instructions and maintain the appointment schedule
* Has dry eye symptoms

Key Exclusion Criteria:

* Has suffered any ocular injury to either eye in the past 12 weeks
* Is pregnant or lactating at the time of enrollment

Other protocol-specified inclusion/exclusion criteria may apply.
Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?

Clonidine is widely used off-label in children for several indications. Clonidine is used for treatment and/or prevention of postoperative agitation in children anaesthetised with Sevoflurane. The investigators don´t have solid evidence for the effect and the investigators don´t have data for characterization of the pharmacokinetic profile among age-groups for children 1-6 years.

In this study the investigators want to investigate if IV Clonidine administered at the end of surgery can prevent/reduce postoperative agitation. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.

BACKGROUND:

Clonidine is widely used off-label in children for several indications such as treatment and/or prevention of postoperative agitation when anaesthetised with Sevoflurane. However, the current level of evidence in support of Clonidine treatment for postoperative agitation in children remains limited. In addition, the pharmacokinetic profile of intravenous Clonidine in children is not well characterized for age-groups.

METHODS/DESIGN:

In this prospective multicentre double-blinded randomized clinical trial, the investigators aim to investigate the impact of intravenous (IV) Clonidine administered at the end of surgery, on the incidence and degree of postoperative agitation. Children will be assigned to either the intervention or the placebo group. The allocation will be carried out centrally and stratified based on age and trial-site, with152 patients allocated to each group. In the intervention group, 3 micrograms per kg of IV clonidine is administered approximately 20 minutes before the expected completion of the surgery (as assessed by the surgeon). In the control group; Saline (placebo) is injected in equal quantity during surgery at the same time. The drugs are concealed in identical blinded ampoules.

The primary outcome is postoperative agitation measured on the Watcha scale. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including 30-day follow-up.

Twenty of the patients age 1-2 years and twenty age \>2 years, with a peripheral venous access in place, will be allocated to drug assay sampling; enabling a compartmental PK analysis based on age group, using non-linear mixed effects models.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for surgery with Sevoflurane as the choice of anesthesia.

Exclusion Criteria:

* ASA classification \>2
* Premedication with Clonidine
* Ex-premature (born before week 37+0 AND \<60 weeks old)
* Intubated before anaesthesia and/or no plans for extubation after anaesthesia.
* Critical illness with haemodynamic instability.
* Active bleeding.
* Cancer.
* Cardiac diseases including arrhythmias.
* Malignant hyperthermia.
* Mental retardation.
* Neurological illness with agitation-like symptoms.
* Weight \>50 kg.
* Allergy to Clonidine.
* Patients treated with methylphenidate / Concerta.
Endoscopic Abraxane Injection Into Pancreatic Cysts

This research study is a pilot study. In this pilot study we are testing the safety of a procedure. "Investigational" means that the Albumin bound paclitaxel (Abraxane) is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved Abraxane injection for your type of medical condition. Treatment of pancreatic cysts often requires follow-up imaging studies and surgical resection of the cysts. As part of standard medical care, you will be undergoing a diagnostic endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in order to evaluate type of the cyst. During the EUS and just after the cyst fluid aspiration, you will undergo the injection of the drug into the cyst cavity if your cyst is thought to be cancerous or precancerous. Cyst fluid will be analyzed for further diagnosis.

You will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. Screening tests include the following: medical history, performance status, assessment of pancreatic cyst by CT, MRI or EUS, blood tests and a pregnancy test.

If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria you will not be able to participate in this research study.

As part of your medical care you will be undergoing an endoscopic procedure EUS-FNA (Endoscopic Ultrasound Fine Needle Aspiration) in order to evaluate and evacuate the cyst fluid. During the EUS-FNA and just after the cyst fluid aspiration, albumin bound paclitaxel will be injected into the cyst cavity.

The study procedure (injection of drug into cyst cavity) takes place over 5 minutes during the EUS-FNA. 2 days after the procedure you will receive a phone call from the research coordinator to check on how you are feeling. 3 months after study procedure participants will undergo a follow up CT to see what happened to the cyst. You will continue to have routine follow up for your medical problems.

Eligibility Criteria:
Inclusion Criteria:

* Mucinous cysts (premalignant or malignant cysts of the pancreas)
* Normal organ and marrow function
* Baseline CT within 6 months of enrollment

Exclusion Criteria:

* Pregnant or breastfeeding
* Acute active pancreatitis
* Complicated pancreatic cysts
* Subjects who do not speak English
Midterm (Min. 3yr) Follow-up of Patients With Single Spiral/Oblique Finger Metacarpal Fracture

Spiral metacarpal fractures (metacarpal II-V) can be treated conservatively or with operation. With minimal displacement this fracture is usually treated with immobilisation or early mobilisation. With appreciable displacement especially any malrotation the patient usually is treated with an operation. This usually includes an open reduction of the fracture and fixation with plates and screws or just screws.

The hypothesis that nonoperative treatment (using early mobilization without splintage) will result in similar outcomes to operative treatment was previously tested by this research group (Peyronson et al. JBJS American 2023). Over a 1-year follow-up the primary outcome of grip strength was found to be noninferior.

This trial will extend the follow-up period and re-evaluate the patients included in the original cohort to identify any difference over a 3-6 year follow up.

The original trial was a noninferiority randomized controlled trial evaluating 42 patients. Randomization was performed 1:1 to either nonoperative treatment with mobilization initiated immediately following recruitment or operative treatment using ORIF with cortical screws or locking compression plate (LCP) and screw fixation.

The non-inferiority margin (NIM) was defined as -15% grip strength of the injured hand relative to the contralateral hand. The same NIM will be used for this trial.

Because subtle biomechanical changes (mainly metacarpal bone shortening) could theoretically cause problems not evident at 1-year follow-up (such as joint degeneration from changes in load distribution), the investigators plan to re-evaluate the patients for a longer-term follow-up.

Only patients included in the original trial will be eligible for inclusion in this extended follow-up. Participation will be offered via mail invitation, and participants will be offered financial compensation in the form of a single payment of 500SEK.

Data collection will be performed in a single outpatient hospital visit where patient history, subjective outcome data and bilateral plain radiography of the hands will be obtained.

Eligibility Criteria:
Inclusion Criteria:

Previous inclusion in the original study population, i.e.:

* Diaphyseal, single spiral, and oblique fractures of the index to little finger metacarpals
* Fracture line length at least twice the diameter of the bone at the level of the fracture
* At least 2-mm displacement and/or shortening of the fracture or malrotation
* Normal hand function before the injury
* Fracture \<10 days old

Exclusion Criteria:

* Multiple metacarpal fractures
* Open fractures
* Inability to follow instructions
* Fracture line length less than twice the diameter of the bone at the level of the fracture
* Abnormal hand function before the injury
* Previous ipsilateral hand fractures
* Fracture ≥10 days old at possible randomization
A Pilot Trial to Evaluate the Effect of Diet and Exercise in Renal Transplant Recipients on Tacrolimus

The purpose of this trial is to investigate whether a combined dietary and exercise intervention, added to standard care, reduces the expected frequency of insulin resistance in renal (kidney) transplant recipients on tacrolimus.

This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single-arm, multi-center (conducted in more than 1 center), interventional pilot study of the effects of a combined dietary and exercise intervention on glucose metabolism. The duration of this study will be 6 months and will include following visits: Baseline, Week 4, Week 12, and Week 24. Dietary compliance will be evaluated with a 3-day food record and during weekly telephone conversations and face-to-face visits with a dietician. Exercise compliance will be measured using an exercise log presented to the co-ordinator at the end of each month. Primarily, participants with insulin resistance will be assessed by Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) of greater than 1 at 6 months. Participants' safety and tolerability will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who has sufficiently recovered from surgery to tolerate an intensive exercise evaluation
* Participants who have received a living-donor or cadaveric (from dead donor) renal transplant
* Participants who has been initiated tacrolimus as first-line immunosuppressive agent
* Participants who has given informed consent forms

Exclusion Criteria:

* Participants with significant disease or disability that prevents taking part in a diet or exercise regime (e.g. cardiac instability, including unstable angina \[chest pain due to decreased oxygen being supplied to the heart\] and/or other unstable disease, severe cognitive \[mental functioning\] impairment)
* Participants with significant post-surgical complications that prevent participation in the exercise component of the study (e.g. wound dehiscence \[pathologic process consisting of a partial or complete disruption of the layers of a surgical wound\] or infection)
* Participants with contraindications to maximal exercise testing or high-intensity progressive resistance training (e.g. proliferative diabetic or hypertensive retinopathy, un-repaired aneurysm, critical aortic stenosis, recurrent symptomatic hernias, New York Heart Association (NYHA) class-IV congestive heart failure)
* Participants with non-ambulatory (mobility) status
* Participants who require ongoing systemic immunosuppressive therapy for an indication other than renal transplant and this therapy is higher than that required for their kidney disease