cyrilzakka/clinical-trials huggingface dataset:
Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres

Post operative acute urinary retension or voiding dysfunction are complications after inguinal hernia repair and they cause a great deal of discomfort and stress to patients. Furthermore, they can also increase hospital costs by increasing hospital stay, and by growing the need for outpatient appointments after an elective surgical procedure. Some studies recommend prophylactic alpha blockers to minimizing these adverse effects.

Investigators aimed to determine the changes of uroflowmetric values for male patients following elective inguinal hernia repair.

Inguinal hernia repair is a common procedure performed in general surgery, with an annual rate of 28 per 100,000 of the population in the USA. The incidence of post operative inability voiding in males following open or laparoscopic inguinal hernia repair varies from 3 to 25%. Evaluating risk factors to reduce the occurence of this complications after one of the most commonly performed surgery by general surgeons could help reduce that high rate of that complication. Although some authors recommend prophylactic alpha blockers, there is no consensus on whether these can decrease rate of urinary retention or voiding dysfunction in male patients.

In current study, investigators aimed to determinate the uroflowmetric parametric changes of patients after elective inguinal hernia repair.

Eligibility Criteria:
Inclusion Criteria:

* any type of inguinal hernia

Exclusion Criteria:

* active urinary tract infection,
* previous BPH, neurological disease or significant systemic disease,
* medications that could interfere voiding function
* history of prostate, bladder or urethral surgery or traumatic urethral catheterisation.
Scheme of Limb Warming Blanket Combined With Dexmedetomidine

Objective: To observe the clinical effect of lower limb warming blanket combined with dexmedetomidine (DEX) in preventing postoperative delirium (POD) and chills in elderly patients undergoing spinal surgery. Methods: A total of 160 elderly patients undergoing posterior spinal surgery under general anesthesia were selected and divided into control group (group N), heating group (group T), DEX group (group D) and heating combined with DEX group (group TD) according to the random number table method, 40 cases in each group. T group and TD group routine insulation and lower limb heating blanket. DEX was injected in group D and group TD. The dosage of anesthetics, the changes of body temperature and heart rate at different time points during operation, and the occurrence of postoperative chills and POD were compared among the groups.


Eligibility Criteria:
Inclusion Criteria:

* Age: between 65-80 years old;
* American Society of Anesthesiologists (ASA) grade II-III;
* Normal body temperature before operation;
* the operation time was 2-4 hours

Exclusion Criteria:

* Preoperative fever or hypothermia (body temperature≥37.5 ℃ or≤35.5℃ on the day of operation);
* Body mass index (BMI) \>30 kg/m2;
* The existence of heart, brain, lung, kidney and other important organs and circulatory system, respiratory system, immune system, central nervous system diseases;
* Patients who had taken antipsychotic drugs or β-blockers before surgery would have a greater impact on intraoperative body temperature and other patients who could not effectively cooperate with this study;
* Patients with operation time more than 5 hours
Retrospective Image Analysis of Degenerative Lumbar Disease Patients

The Dynesys dynamic stabilization (DDS) system is considered a motion-preserving device. However, studies addressing the change in the range of motion (ROM) are limited. Therefore, this study aimed to investigate the factors influencing ROM change at the index surgical level, supra-index level, and whole lumbar spine, in addition to the association between ROM preservation and the incidence of screw-loosening.

Decompression with instrumented fusion is an effective surgical intervention for lumbar degenerative spondylolisthesis with spinal stenosis. However, the range of motion (ROM) decreased at the index surgical level may lead to an increased ROM at the non-surgical level, increase biomechanical stress at the transitional adjacent segment, and lead to adjacent segment degeneration (ASD) .

The Dynesys dynamic stabilization (DDS) system is a pedicle screw-based, motion-preserving, and non-fusion stabilization developed as an alternative to the rigid instrumented fusion for degenerative spondylolisthesis. The aim of the DDS is to maintain segmental motion at index levels and to reduce the incidence of ASD. However, the actual impact of ROM has remained elusive. Prior studies have reported an average ROM loss of 1.1º to 17.3º 7 at index surgical level at an average of 24 months follow-up.

The change of ROM at index surgical, supra-index, and whole lumbar spine following DDS remains unclear. This study aims to investigate the factors influencing the ROM change at index surgical level, supra-index level, and whole lumbar spine, and the association between ROM preservation and the incidence of screw-loosening.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Diagnosed with degenerative spondylolisthesis over L4-L5
* Received DDS
* Received a minimum of 2-year follow-up were reviewed.

Exclusion Criteria:

* presence of degenerative scoliosis or spinal deformity,
* prior spine surgery,
* lost to follow-up, or
* failure to complete the questionnaires or radiographic examinations.
Immunoglobulin G Therapy Dose Optimization

The overall goal of this proposal is to investigate effects of obesity on pharmacokinetics of immunoglobulin G (IgG) and to develop strategies for optimization of dosing of IgG in obese patients. There is an ongoing debate regarding the most appropriate dosing of IgG formulations in obese patients. Obesity poses significant health risks; and evidence supporting dosing strategies of IgG in obese patients is inadequate. Some of the adverse reactions have been attributed to a relative overdosing in these patients, due to a limited distribution of IgG into fat tissue.

The estimated prevalence of overweight and obese individuals \>20 years in the US is 154.7 million (nearly double since the early 1960s), and over 1.6 billion people are considered overweight or obese worldwide. Compounding the health risks associated with obesity is the insufficient data supporting dosing strategies for a variety of medication used to treat conditions encountered in obese patients. No consensus on the best dosing strategy for IgG in obese patients has been established. Total (TBW), ideal (IBW), and adjusted (AdjBW) body weight-based dosing are being utilized by different institutions. Thus, there is an urgent need to identify evidence supporting optimal dosing strategies for IgG.

It has been proposed that using TBW to dose IgG in obese patients may increase the risk of thrombosis owing to increased blood viscosity, activation of platelets, or vasospasm; and the increase in blood viscosity has been reported as IgG dose dependent. The use of using IBW or AdjBW has been advocated to reduce the side effect and drug expenditures. It is currently unknown what the clinical impact is of using measures of body weight other than TBW to calculate IgG doses, and the effect of obesity on IgG pharmacokinetics has not been experimentally evaluated.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 75 years
* currently treated with IVIG

Exclusion Criteria:

* liver impairment (elevations in liver enzymes of greater than 3 times the upper limit of normal)
* reduced renal function (CrCl \< 50 mL/min)
* Patients with a pacemaker or an automatic implantable cardioverter-defibrillator
CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression

This study is a randomized controlled trial that tests the effectiveness of cognitive behavior therapy (CBT) for insomnia with comorbid depression in youth aged 12 through 19 who have recently begun selective serotonin re-uptake inhibitor (SSRI) antidepressants. CBT is compared with a control condition of sleep hygiene education.

160 youth with depression and comorbid insomnia who have just initiated a course of SSRI antidepressants will be randomized to insomnia-focused cognitive behavior therapy (CBT-I) or an attention control condition of sleep hygiene (SH) education. All participants will have in-person treatment sessions and will complete sleep diaries and wear an actigraph to record activity levels. Participants will be followed for 12 months.

Primary depression outcomes are score on the Clinical Global Impressions Improvement (CGI-I) and major depressive disorder diagnostic remission; primary sleep outcomes are actigraphy total sleep time and score on the Insomnia Severity Index (ISI). Secondary outcomes include additional sleep and depression outcomes. The study will also include economic analyses.

Eligibility Criteria:
Inclusion Criteria:

* Age 12 to 19
* Major depression based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
* Recent dispense of SSRI antidepressant
* Subjective complaint of insomnia ≥ one month
* Score of ≥ 9 on Insomnia Severity Index

Exclusion Criteria:

* Active, progressive physical illness or neurological degenerative disease
* Sleep apnea, restless legs, or limb movements during sleep
* Diagnosis of delayed sleep phase syndrome (DSPS)
* Mental retardation, autism spectrum disorder (ASD), or other significant pervasive developmental disability (PDD)
* Sleep treatments including over-the-counter (OTC) sleep medication or CBT for insomnia
* Medications known to alter sleep
* Diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder
Evaluating Quebec's Red-Cross Intervention

With the COVID-19 pandemic, elderly people (EP) living at home have seen their health deteriorated, thus increasing their needs in support and care. Indeed, while it was estimated that before the pandemic120 000 unattended living at home EP required care and services (taking bath, access to medication and food, etc.), the number doubled after COVID-19. Therefore, the waiting list for socio-medical services for unattended vulnerable clientele without a family doctor grew from 1300 to 1715 EP in a couple of months during the pandemic. With these numbers, it becomes clear that an intervention is needed. Truly, the Institut National d'Excellence en Santé et Services Sociaux (INESSS) concludes that it was pivotal to first identify the most vulnerable EP and second re-orient them according to their needs.

Thus the principal investigator developed the Évaluation et orientation SOcio-GÉRiatrique (ESOGER) questionnaire available on a secure digital platform enabling both a rapid evaluation and intervention to asses EP needs and provide the adequate ressources. The principal investigator's previous research has demonstrated that ESOGER is one of the rare clinical tools of first contact in telehealth while being global, multidimensional, and equitable.

Hence, the principal investigator hypothesizes that ESOGER is a clinical tool enabling first line care by the Red-Cross to vulnerable EP without a family doctor, which will lead to an improvement in their health, autonomy and quality of life. Moreover, the principal investigator also hypothesizes that for a better deployment, the tool needs to be adapted to Red-Cross' need and EP service providers.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 and more
* Living at home
* Be registered at the waiting list of GACO at the CIUSSS-Centre-Sud de l'île-de-Montréal (CCSMTL)

Exclusion Criteria:

* Principal address outside of the CCSMTL territory
* Participate at another clinical trial, to avoid interferences
* Not understand written or spoken French or English, questionnaires are only available in French and English.
COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications

The purpose of this study is to test whether Fisetin, a senolytic drug can assist in the reduction of complications in patients with COVID-19 infection.

To determine whether short-term treatment with Fisetin reduces the rate of death and long term complications related to COVID-19 and to determine the safety of treatment with Fisetin in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, at least 18 years of age, capable and willing to provide informed consent;
* Patient must have received a diagnosis of COVID-19 infection within the last 3 days;
* Outpatient setting (not currently hospitalized);
* Patient must possess at least one of the following high-risk criteria: 60 years or more of age, obesity (BMI ≥ 30 kg/m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥150 mm Hg), known respiratory disease (including asthma, chronic obstructive pulmonary disease, or present or past smoking), known heart failure, known coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at the time of presentation, the combination of high neutrophil count and low lymphocyte count;
* Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after study completion;
* Patient or their caregiver must be able and willing to comply with the requirements of this study protocol.

Exclusion Criteria:

* Patient currently hospitalized or under immediate consideration for hospitalization;
* Patient currently in shock or with hemodynamic instability;
* Patient with severe hepatic disease (as per clinical judgement) and liver enzymes \>10x the upper limit of normal;
* Female patient who is pregnant, breast-feeding, or is considering becoming pregnant during the study or for 1 day after the last dose of study medication;
* Patient currently taking Sirolimus, Tacrolimus, or other mTOR inhibitors for other indications (mainly chronic indications represented by organ transplantation or autoimmune diseases);
* On Warfarin therapy;
* Patient with a history of an allergic reaction or significant sensitivity to Fisetin;
* Patient undergoing chemotherapy for cancer;
* Patient is considered by the investigator, for any reason, to be an unsuitable study candidate.
Brief Online Cognitive Behavioral Therapy for Indian Expatriates with Excessive Worry: a Pilot Feasibility Study

Background: Expatriates may face challenges through distance from support systems, cultural adjustments, and language barriers, which may be associated with anxiety and elevated worry, particularly in times of ongoing global crises. Brief online cognitive-behavioral therapy (ICBT) is effective for treating excessive worry but has not been adapted for expatriate communities in Sweden.

This pilot study aimed to investigate the feasibility, acceptability, and preliminary treatment effects of a five-week, therapist-guided, culturally adapted ICBT program. The program targeted excessive worry related to ongoing global crises among Indian expatriates.

Eligibility Criteria:
Inclusion Criteria:

* identifying as Indian expatriate currently living in Sweden
* self-reported dysfunctional worry, defined as worrying several times a day and the worry being experienced as difficult to control
* age ≥ 18 years;
* able to provide digital informed consent
* having daily access to a device with internet connection.

Exclusion Criteria:

* non-English speaking
* self-reported severe depression (\>28 points on the Montgomery Åsberg Depression Rating Scale (MADRS-S; (Svanborg \& Åsberg, 1994)
* suicidal risk (5 points on item 9 on the MADRS-S).
Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study

This is a randomized, controlled study to compare Short-term ketogenic diet with conventional long-term trial in refractory infantile spasms.


Eligibility Criteria:
Inclusion Criteria:

1. Patients, who have recalcitrant infantile spasms and undertake the ketogenic diet at Severance Hospital and Sanggye Paik Hospital from 2005 to 2008.
2. Clinical and electroencephalography findings are compatible with infantile spasms
3. Spasms are intractable to the initial combination of vigabatrin (150 mg/kg) and topiramate (10 mg/kg) and/or additional indicated anti-epileptic drugs including prednisolone (2 mg/kg for 2 weeks and an additional 2 weeks for tapering).
4. Study entry requires magnetic resonance imaging to confirm the absence of a progressive cerebral lesion.

Exclusion Criteria:

1. Patients who have a history of hyperlipidaemia and underlying metabolic diseases including acute intermittent porphyria, pyruvate carboxylase deficiency, and fatty acid oxidation defects.
2. Patients who have a history of nephrolithiasis.
Evaluation of the Accuracy of an Implanted Glucose Sensor

The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements The investigation will also evaluate safety of the Senseonics CGM System usage.


Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects, age ≥18 years
2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
3. Subject has signed an informed consent form and is willing to comply with protocol requirements

Exclusion Criteria:

1. History of severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
3. Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study.
4. A condition preventing or complicating the placement, operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition.
5. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic\>160 mm Hg or diastolic \>100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e,g, CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented.
6. Hematocrit \<30% or \>55%
7. History of hepatitis B, hepatitis C, or HIV
8. Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study.
Probiotic BL NCC 2705 and Gluten Sensitivity

The aim of the study is to confirm/prove safety of the probiotic and production of serpin in humans.

This trial is a multicenter, double blind, randomized, placebo controlled, 2 by 2 cross-over design (i.e. 2-sequences, 2-periods, 2-treatments) for each specific population (i.e. self-reported Non Coeliac Gluten Sensitivity and Coeliac Disease subjects).

1 capsule of BL NCC 2705 or placebo will be given twice a day in the morning and in the evening with a meal over 2 periods of 4 days.

On day four a single dose of gluten (3g) will be administered and duodenal fluid will be collected in the following hours through a naso-intestinal catheter. The viability of BL NCC 2705, the production of serpin and its effects on gluten digestion and intestinal enzymatic activity will be determined.

No chronic administration of gluten as a challenge is foreseen in the study.

After a wash out period of minimum 2 weeks, period will be repeated.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to sign written informed consent prior to trial entry
2. Male or female adults \>18 years of age
3. For NCGS: self-reported gluten sensitivity with negative CD serology, on gluten free diet for at least 6 weeks with self-reported significant symptomatic improvement
4. For CD: confirmed serologic and histologic diagnosis of CD and on GFD for at least 12 months with self-reported significant symptomatic improvement
5. Body Mass Index (BMI) within the range \>18 - \<30 kg/m2
6. Willing and able to comply with study procedures and restrictions
7. In good health as determined by a medical history and medical examination

Exclusion Criteria:

1. Documented IgE-mediated food allergy
2. Subjects following an overly imbalanced or restrictive diet as per nutritional advice
3. Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be detrimental for the participants safety or potentially interfering with the study procedures and/or study outcomes
4. Concurrent organic GI pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli
5. Previous abdominal surgery with the exception of hernia repair, appendectomy, caesarian section, tubal ligation, hysterectomy, hemorrhoidectomy
6. Patients who received antibiotics in the previous 2 weeks
7. women of childbearing potential not willing to use an effective contraception method
Vitamin D Levels and Postoperative Pain in Laparoscopic Cholecystectomy

The deficiency of vitamin D is common in patients with gastrointestinal system disorders.

Vitamin D has been associated with chronic non-specific musculoskeletal pain and migraines due to anti-inflammatory effects.

This prospective observational study will undergo elective laparoscopic cholecystectomy surgery between 18 and 65 years, is planned to participate in ASA (American Society of Anesthesiologists) 1-3, 90 volunteer patients.

In preoperative evaluation, the remaining 3 ml of blood was centrifuged from the routine received blood to determine the level of vitamin D will be kept.

Postoperative will be applied to patient controlled analgesia to all patients for 24 hours.

To determine the level of postoperative pain, the visual analog scale (VAS) will be used in the clock unit and at the service 6, 12 and 24 hours.

In this study, the investigators aimed to test the hypothesis of relation to pain and opioid consumption in acute postoperative (24 hours) of perioperative low-vitamin D.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer,
* Between the Ages Of 18-65,
* Least Primary School Graduate,
* Not Using Drugs That May Affect Cognitive Functions,
* Non-Alcohol Substance Use,
* Patients Without Psychiatric and Neurological Disease.

Exclusion Criteria:

* Those with known psychiatric disease and drugs,
* Those with an important cardiovascular or central nervous system disease,
* Patients with pain syndromes or routinely using opioid.

Very urgent patients