cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation

As study to investigate the efficacy and safety of daily doses of paroxetine of 15 and 20 mg for the treatment of premature ejaculation

Randomized, double blind, placebo controlled, prospective and parallel trial. Men with premature ejaculation using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for at least 6 months, with an intravaginal ejaculatory latency time (IELT) ≤ 3 minutes. Three treatments are to be compared: placebo, 15 mg or 20 mg paroxetine for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* men between 20 and 70 years of age
* with a stable relationship with a female partner
* with the intention to continue with the same partner for the duration of the study
* with diagnosis of premature ejaculation according to the criteria established in the Diagnostic and Statistical Manual of Mental Disorders IV edition, Revised Text for at least 6 months before inclusion
* with an Intravaginal Ejaculatory Latency Time (IELT) ≤ 3 minutes in at least 75 % of a minimum of three sexual encounters, elapsing between them at least 18 hours during the selection phase of the study
* with agreement to avoid pregnancy or planned surgery during the study,
* female participants should not be pregnant at the inclusion
* both male and female partners had to agree to participate and to sign the informed consent form

Exclusion Criteria:

* any medical or surgical condition that could be associated with the initiation of premature ejaculation for secondary PE
* history of myocardial infarction or stroke in the last 6 months
* hemorrhagic disorder, hepatitis B or C, HIV infection, penile implant surgery at any time
* alcohol or drug abuse in the last 2 years
* any medical or psychiatric condition that could interfere with study procedures and evaluations
* uncontrolled diabetes
* hypotension (defined as systolic/diastolic blood pressure \< 90/50 mm Hg)
* uncontrolled hypertension
* diagnosis of erectile dysfunction or a score ≤ 21 in the erectile function domain of the International Index of Erectile Function (IIEF) at inclusion
* treatment with any investigational drug in the last month or 5 times the half life of the drug
* use of medications that could enhance the effect of paroxetine,
* known intolerance to selective serotonin recapture inhibitors
* hypoactive sexual desire not caused by PE
* sexual dysfunction in the female partner that could interfere with participation
* any other significant clinical conditions that could interfere with study procedures
* employees of research sites and relatives of researchers
Pulmonary Rehabilitation Combined With Speleotherapy in Children With Bronchial Asthma

The goal of this retrospective study is to learn about the effects of rehabilitation and treatment stays combined with speleotherapy in children with asthma. Medical records of 415 patients with this clinical diagnosis were analyzed and the main question was:

• Does speleotherapeutic intervention increase distance in 6-Minute Walk Test (6MWT) and influence spirometry parameters and fractional exhaled nitric oxide concentration (FeNO) in children with asthma?

Background: Bronchial asthma is the leading cause of chronic disease and missed school days in children. The aim of the study was to evaluate pulmonary function and exercise tolerance in children with asthma who underwent speleotherapeutic intervention (STI) between January 2022 and October 2023 at Sanatorium Edel in Zlaté Hory.

Methods: Medical records of 415 patients with clinical diagnosis of bronchial asthma (J45.9, J45.0, J45, J45.8, J45.1) were analysed. The patients attended rehabilitation and treatment stays with a median length of 32 days combined with an average number of 15 speleotherapy sessions. The spirometry parameters, fractional exhaled nitric oxide concentration (FeNO), and 6-Minute Walk Test (6MWT) distance were measured before and after STI.

Eligibility Criteria:
Inclusion Criteria:

- Children with asthma who partcipated in speleotherapeutic intervention in Sanatorium Edel in Zlate Hory

Exclusion Criteria:

* Patients with incomplete data
Yoga as a Therapy for Traumatic Experiences

The purpose of the proposed research is to conduct a feasibility study of yoga as an adjunctive therapy for the treatment of posttraumatic stress disorder (PTSD) in 15 military personnel at the Walter Reed Army Medical Center (WRAMC) in Washington, DC. Participants will complete 10 weeks of yoga training, in addition to the continuing their usual and customary care for PTSD at WRAMC. The style of yoga chosen for this study, Yoga Nidra, uses deep relaxation, deep breathing and meditation to systematically reduce physical, emotional, mental, and even subconscious tension. After a diagnostic mental health assessment at baseline, participants will attend a total of 18 classes taught over a 10-week period and will practice daily at home using a compact disk provided by the instructor. Baseline measures will include the Patient Health Questionnaire, PD-HAT Trauma Questions, PTSD Symptom Scale - Interview, Fear of Loss of Vigilance Scale, and expectation of efficacy. The primary outcome measure will be the PTSD Checklist. Changes in health status, locus of control, and pain will be assessed over the course of the study. An additional goal of this study is to gather preliminary data on the anticipated effect size and feasibility of conducting a larger clinical study of the adjunctive use of yoga for the treatment of PTSD symptoms in enlisted military personnel.


Eligibility Criteria:
Inclusion Criteria:

* Active Duty military personnel
* Aged 18 and over
* A minimum score of 40 on the Posttraumatic Stress Disorder Checklist (PCL-M), a brief, self-report instrument used to assess PTSD severity.

Exclusion Criteria:

* Active suicidal or homicidal ideation
* Severe cognitive impairment or history of cognitive disorder
* Serious surgical procedures within the last two months or planned
* Treatment for refractory pain
* New or dose adjusted psychotropic medication (i.e. SSRIs and anxiolytics) in last month
* Unwilling or unable to practice Yoga Nidra at home
* Amputation of any body part
Prebiotic and Anti-inflammatory Effects of a Pectin Polysaccharide

The aim of this study is to determine, quantify and understand the potential prebiotic and anti-inflammatory effects of the pecticpolysaccharide rhamnogalacturonan I (RG-I). The effects of these dietary fibre fractions on barrier function will also be investigated.

The dietary fibre fractions from RG-I will be tested first for their prebiotic potential. Batch culture fermentation systems containing basal growth medium will be inoculated with faecal homogenates obtained from different time points (Task I) and will be used for analyzing microbiota composition and microbiota-associated metabolites. Subsequently, the collection of colon biopsies through sigmoidoscopy procedure of the same subjects will take place and the collected biopsies will be mounted in Ussing Chambers. Supernatants collected from Task I will be added to the mucosal side of the biopsy together with a stressor and two permeability markers, in order to investigate the effects of the fibre fractions on both paracellular and transcellular permeability.Throughout the study subjects will complete questionnaires related to their gastrointestinal health and dietary habits

Eligibility Criteria:
Inclusion Criteria:

1. Signed consent prior to any study related procedures
2. Age 18-65 years
3. Willing to abstain from regular consumption of prebiotics/probiotics products or medication known to alter gastrointestinal functions at least 4 weeks prior to the study visits

Exclusion Criteria:

1. Previous complicated gastrointestinal surgery
2. Presence of gastrointestinal disorder or any disorder which the principal investigator considers to affect the results of the study
3. Current diagnosis of psychiatric disease
4. Current and past diagnosis inflammatory gastrointestinal disease (e.g. Irritable Bowel Disease)
5. Systemic use of antibiotics or steroids medications in the last 3 months
6. Frequent use of NSAID (Non Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits
7. Regular consumption of prebiotic/probiotic products for the past 4 weeks
8. Abuse of alcohol or drugs
9. Frequent use of laxatives, anti-diarrheal, anti-cholinergic within last 12 weeks prior to study visits
10. Pregnancy and breast-feeding
Barrett's Esophagus Patient Registry

The ultimate goal of the Barrett's Esophagus Patient Registry is to help develop more effective targeted screening strategies and treatment options for Barrett's esophagus and esophageal adenocarcinoma (EAC). We plan to do by developing a registry that will serve as a platform. Examples of analyses could include identifying genetic determinants and biomarkers that predict BE, progression of BE to EAC, as well as the response to therapies.


Eligibility Criteria:
Inclusion Criteria:

* Barrett's (BE): Patients who have Barrett's esophagus (all stages: Barrett's metaplasia, low-grade dysplasia, high-grade dysplasia) based upon standard endoscopic and histologic criteria.
* Adenocarcinoma (EAC): Patients who have esophageal adenocarcinoma.
* The control cohort will include patients ages 18 and older with no prior history of BE and EAC. These may include patients who are being seen or have been previously seen at MGH GI Associates for conditions including gastroesophageal reflux disease, peptic esophagitis, eosinophilic esophagitis, esophageal motility disorders such as achalasia and nutcracker esophagus.

Exclusion Criteria:

* Inability or unwillingness to provide blood samples.
* History of known bleeding disorders.
* Currently awaiting organ transplantation.
* Having an acute or severe chronic illness such as congestive heart failure or any other condition that would prohibit performing the endoscopy.
Postpartum Quality of Recovery & Maternal Satisfaction After C/S

Measuring patient-oriented outcomes and satisfaction is important to guide meaningful changes in obstetric anesthesia care. Quality of Recovery (QoR) scores are patient rated measures, which provide a global measure of recovery after surgery. They go beyond the measure of physiological variables to include, physical, cognitive, emotive and functional outcomes. Satisfaction, in addition to QoR scores after anaesthesia is an important quality marker. Measuring satisfaction after the birth of a child is a complex and emotive subject. Understanding the factors that can influence maternal satisfaction may improve patient-centred care. Studies have shown that despite favorable clinical outcomes, many women undergoing caesarean deliveries continue to have poor experience with anaesthesia. These poor experiences go beyond inadequate pain control; many are due to poor communication with clinicians, lack of involvement in decision making, lack of provision of high quality education and information and a feeling of inadequate choice and control relating to decisions of the birth of their babies. In non-obstetric studies, satisfaction after anaesthesia has consistently been shown to be dependent on the information patient has received along with the quality of the communication and the quality of the anaesthetist-patient relationship.


Eligibility Criteria:
Inclusion Criteria:

* Fluent English speaker
* Older than 19 years of age
* Received a cesarean delivery
* Received a cesarean delivery 24-48 hours prior to time of recruitment

Exclusion Criteria:

* Non-English speaker
* Below the age of 19 years
* Did not receive a cesarean delivery
* Received a cesarean delivery more than 48hrs after time of recruitment
MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy

The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS).

Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Clinically confirmed viable pregnancy at the time of enrollment
* Clinically determined gestational age between 8 wks, 0 days and 22 wks, 0 days
* Referred or planning to undergo CVS or amniocentesis procedure due to risk of fetal aneuploidy based on protocol-specified clinical indicators
* Able to provide consent for participation using language appropriate forms and consent process

Exclusion Criteria:

- Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment
A Brief Parent-based Sleep Intervention for ADHD Children

Sleep problems are very common in children with ADHD, with a prevalence rate as high as 73%, and often pose significant challenges and stress to the families. Sleep problems in ADHD children are strongly associated with the exacerbation of daytime symptoms, impaired physical health, and poor parental mental health. The present study is a randomised controlled trial to compare the effects of a parent-based sleep intervention for children with ADHD (aged 6-12). Eligible participants will be randomised to either intervention (two face-to-face consultation sessions and one follow-up phone call) or waiting-list control condition. Assessments will be conducted at pre-treatment (baseline), one-week after the intervention (post-treatment), and 3 months after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Aged 6-12 years old;
* With a clinical diagnosis of ADHD (any subtype), as confirmed by the Diagnostic Interview Schedule for Children-version-IV (DISC-IV);
* With parent-reported insomnia (difficulty initiating sleep and/or maintaining sleep).

Exclusion Criteria:

* Children with a serious medical condition (e.g. severe cerebral palsy) or intellectual disability (IQ\<70);
* Children with a neurological and/or medical condition that may lead to disordered sleep;
* Suspected clinical sleep disorders (e.g. obstructive sleep apnea, OSA) that may potentially contribute to a disruption in sleep continuity and quality, as assessed by the Children's Sleep Habits Questionnaire (CSHQ). If the child is suspected of a clinical sleep disorder, he/she will be referred to appropriate services;
* Children who are already receiving specialised help (behavioural intervention) for their sleep from a psychologist or at a specialized sleep clinic.
The Effect of Guided Narrative Technique on Child Post-traumatic Stress Symptoms Related to Teachers' Improper Criticism

Teachers' improper criticism may lead to posttraumatic stress symptoms (PTSS) in children. This cluster randomized controlled trial examined the effect of guided narrative technique (GNT) on child PTSS caused by teachers' improper criticism in school settings.


Eligibility Criteria:
Inclusion Criteria:

* 5th grade students
* 7-13 years old
* with the ability to read and write

Exclusion Criteria:

* younger than 7 years old or older than 13 years old
* having psychotic disorders
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies

This study will evaluate the long-term safety of ARD103 cellular therapies

Participants who receive administration of ARD103 (i.e., a partial dose or a full dose) will roll into the LTFU study upon completion of the 24-month interventional study period (Study: ARD103_ARCE-CL-P-001), or after early discontinuation from the interventional study protocol. The LTFU study is a study intended to characterize long-term safety for 15 years post-ARD103 administration. Participants who complete the full 24-month interventional study period will undergo an additional 13 years of monitoring under the LTFU study. No IP will be administered during the LTFU study. The number and percentage of participants with ARD103 CAR-T cell therapy related AEs, SAEs, and AESIs will be recorded throughout the LTFU Period.

Eligibility Criteria:
Inclusion Criteria:

* The participant has R/R AML or MDS and has previously received ARD103 CAR-T cell therapies in the parent study.
* The participant is able to understand and comply with protocol-required study procedures and has provided a written informed consent document.

Exclusion Criteria:

* There are no specific exclusion criteria for this study
Phase II Study of Pre-Operative Chemotherapy in Patients With Resectable Local-Regional Carcinoma of Esophagus

This study is designed pre-operative for patients with resectable, local-regional carcinoma of the esophagus.

This study is designed for patients with resectable, local-regional carcinoma of the esophagus. In a pre-operative setting, chemotherapy with Taxol, Cisplatin, and 5-Fluorouracil will be administered followed by G-CSF.

Eligibility Criteria:
Inclusion Criteria:

* Measurable disease with resectable local-regional carcinoma of the esophagus. 18 years of age or older.

Exclusion Criteria:

* Pregnant or lactating. Non-resectable local-regional carcinoma of the esophagus.
No Stoma VS Ghost Stoma in Patients Undergoing Total Mesorectal Excision for Rectal Cancer

This study aimed at comparing the Comprehensive Complication Index (CCI), readmission rates, postoperative hospitalization days, duration of bearing the stoma (months), hospitalization costs, the number of hospitalizations with ghost ileostomy group versus no ileostomy group after total mesorectal excision for rectal cancer.

So far, there are no relevant reports on ghost ileostomy among the Asian population, and all studies are small sample studies.In the past decades, with the advent of circular stapling devices, many middle and low rectal cancers have chosen new sphincter-saving procedures (such as ISR and Ta TME). Nevertheless, when the incidence rate of AL remains high, is diverting ileostomy applicable? Is ghost ileostomy applicable to rectal cancer in the context of new surgical procedures such as pelvic floor reconstruction, perineal drainage, anastomotic reinforcement and robotic surgery? Is this delayed stoma safe and feasible with the increase of preoperative neoadjuvant therapy? Therefore, our study proposes to summarize the review of the complications of GI and no stoma to explore the safety and effectiveness of GI in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed rectal cancer.
* age ≥18 years and ≤80 years.
* intraoperative ghost ileostomy or no stoma was performed.

Exclusion Criteria:

* ASA score \>3.
* Patients with coexisting complete intestinal obstruction.
* History of long-term use of immunosuppressive drugs or glucocorticoids.
* Combined severe cardiac disease: with congestive heart failure or NYHA cardiac function ≥ grade 2.
* Patients with a history of myocardial infarction or coronary artery surgery within 6 months before the procedure.
* chronic renal failure (requiring dialysis or glomerular filtration rate \<30 mL/min).

Intraoperative combined multi-organ resection.

* Combined cirrhosis of the liver.
* Intraoperative findings of incomplete anastomosis and positive insufflation test.
Closure of the Appendix Stump in Laparoscopic Appendectomy

Aimed to the study evaluate the superiority of intracorporal sutures and Hem-o-lok clips in terms of efficiency.

Performed laparoscopic surgery for acute appendicitis. Appendiceal stump was closed by Hem-o-lok clips (Group I) and intracorporal knotting (Group II) in a randomize manner. Groups were compared for cost effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute appendicitis

Exclusion Criteria:

* under 18 years of age
* other patology in addition to appendiceal pathology
A First Time in Man Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1979 in Healthy Males

This is a first time in human study to assess the safety and tolerability of AZD1979 following oral administration of single ascending doses in healthy male volunteers. Pharmacokinetics (what the body does to the drug) parameters will also be assessed as secondary objectives.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male volunteer aged 18 to 50 years
* Have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive

Exclusion Criteria:

* History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP
* Any clinically important abnormalities in clinical chemistry, endocrine hormones, hematology, or urinalysis results as judged by the Investigator
Polypharmacy and Outcomes After Elective Noncardiac Surgery

This study investigates the association of preoperative polypharmacy with outcomes and healthcare resource utilization in a population-based sample of older patients enrolled in a universal pharmacare program

Multilevel multivariable regression analysis will be used to investigate the adjusted association between preoperative polypharmacy and postoperative outcomes and healthcare resource utilization. Sensitivity analyses will be used to evaluate the robustness of the primary analysis.

Eligibility Criteria:
Inclusion Criteria:

* Intermediate to high risk elective non-cardiac surgery
* Age \>=66 on day of surgery

Exclusion Criteria:

-
Reduced Intensity Transplant Conditioning Regimen for Severe Thalassemia

This study is being done to determine if blood cell transplants, with either bone marrow or cord blood from unrelated donors, are effective in children with severe thalassemia and if this treatment approach has acceptable risks and side effects.

This study includes a preparative regimen with Hydroxyurea, Alemtuzumab, Fludarabine, Thiotepa and Melphalan that provides intense host immunosuppression without myeloablation. The primary hypothesis is that this regimen will promote stable engraftment of unrelated donor hematopoietic cells, support normal erythropoiesis, and result in an event free survival of \> 75% of children with thalassemia major.


Eligibility Criteria:
Inclusion Criteria:

* 1-16.00 years old
* Have transfusion dependent thalassemia major
* Shall not have an HLA-matched family donor
* Must have a suitably matched unrelated marrow donor or UCB product
* Lansky score \>/= 70
* Adequate pulmonary, renal, liver, and other organ function as defined in protocol
* Negative pregnancy test
* Adequate total nucleated cell or CD34+ dose of product as defined in protocol
* Iron chelation must be discontinued \>/= 48 hours prior to conditioning regimen

Exclusion Criteria:

* Pregnant or breastfeeding
* HIV positive
* Prior allogeneic marrow or stem cell transplantation
Evaluation of the Consequences of Poly Vaccination on Innate Immunity : Applications to a Military Population

In this study, the poly vaccination of military personnel prior to deployment will be analyzed in terms of central, peripheral and long-lasting changes in innate immunity.

Analysis of monocyte immune training induced by vaccination will provide a better understanding of the indirect effects of vaccination and their persistence over time.


Eligibility Criteria:
Inclusion Criteria:

* french military personnel
* \>18yo
* overseas deployment scheduled between 30 and 60 days after vaccination session
* adult
* able to give consent

Exclusion Criteria:

* unrectified military personnel
* having received a live vaccine within 6 months prior to inclusion
* having received an attenuated vaccine within 3 months prior to inclusion
* pregnancy or breastfeeding
* vaccine contraindication
* major incapacity