cyrilzakka/clinical-trials huggingface dataset:
Effectiveness and Safety of TENS Therapy for Premature Ejaculation

The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. The main question to answer is:

Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation, compared to standard pharmacological treatment with dapoxetine?

Patients will:

Be randomized in acontrolled clinical trial. Patients with a diagnosis of premature ejaculation who attend Boston Medical Group clinics in Mexico City will be included.

Be assigned by randomization to one of three treatment groups:

* Group 1: Tens therapy + dapoxetine placebo on demand.
* Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.
* Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).


Eligibility Criteria:
Inclusion Criteria:

* Primary premature ejaculation according to the definition of the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation always or almost always occurs within the first minute after penetration, b) inability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, annoyance, frustration and/or avoidance of sexual intimacy.
* Age between 18 and 62 years.
* PEDT score greater than 11.
* Stable heterosexual relationship for at least 6 months with interest in maintaining it for at least the duration of the study.
* Sexual activity at least once a week.
* Minimum chronicity of PD of 6 months.
* Voluntary participation in the study.
* Signing of the informed consent prior to participation in the study.

Exclusion Criteria:

* IIEF-EF score less than 26.
* Glaucoma
* Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotor, endocrine, oncological, renal or rheumatological.
* History of retroperitoneal surgery, radiotherapy or multiple sclerosis.
* History of mental illness: depression, anxiety, suicidal behavior, bipolar disorder, agoraphobia, dysthymia, social phobia, obsessive-compulsive disorder, post-traumatic stress disorder, psychiatric disorder, reported by the patient or due to the use of a medication for one of these conditions.
* Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
* Treatment for PE in the last 3 months.
* Treatment for epileptic syndromes or Parkinson's disease.
* Use of pacemaker or cardiac defibrillator.
* Skin lesions in the area where the electrodes are placed.
* Abuse or dependence on psychoactive substances: alcohol, hallucinogenic drugs.
* Couple who are pregnant or interested in conceiving a pregnancy in the next 3 months.
Accelerated Rehabilitation After Arthroscopic Bankart Repair Surgery

The aim of this study was to prospectively evaluate the efficacy of an accelerated rehabilitation regime for patients undergoing early arthroscopic stabilization for first-time anterior dislocation in terms of clinical outcome, return to play data and recurrence rates.

Traditional rehabilitation regimes post arthroscopic stabilization commonly stipulate a period of immobilization of between 2 weeks and 6 weeks.This is apparently embedded in practice and is reportedly based on tissue healing times. However early mobilisation would allow good clinical results in terms of clinical outcome, return to play data and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

* Patient were included based on their history of a clear mechanism of injury resulting in traumatic anterior dislocation, with clear evidence of labral injury confirmed on magnetic resonance imaging.

Exclusion Criteria:

* patients with inflammatory, autoimmune, endocrine or kidney diseases
* Recurrence
* Bony Bankart Lesion
A Pilot Study Investigating the Impact of Different IOL Designs on Subjective 2D and 3D Image Quality

The WHO, states that age related cataracts account for 51 percent of worldwide blindness and affect about 20 million people. Surgery with intraocular lens (IOL) implantation is the first line treatment for cataracts, thus there is an on going effort to improve IOL design and performance.

It is planned to compare three different IOL designs in a psychophysical test setting. Most IOL testing is done in 2D scenarios such as Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity or contrast sensitivity testing. The use of 3D scenario would allow testing a more real-life situation.

As various downsides of different IOL designs have been reported, testing of IOLs before surgical implantation is a promising approach to maximise patient satisfaction. Known deficiencies include amongst others reduced contrast sensitivity or light intensity.

To test three different IOL designs, it is planned to have 2D healthy young subjects look through a stable, table mounted spectacle frame, in which the different IOLs can be inserted. This allows for subjective testing of IOL's in a 2D and 3D scenario.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings
* Refractive spherical error between between -1 and +1 diopters, refractive cylindrical error between -0,25 and +0,25 diopters
* Dominant eye : right eye ( used as study eye)

Exclusion Criteria:

* Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
Spiking-and-Recovery Experiment DOREMI Study

The purpose of this study is to test the validity of our in-house chemiluminescence assay for measurement of folliclestimulating hormone (FSH) serum levels before and during exogenous recombinant FSH (rFSH) administration.

Study question Does our in-house Beckman-Coulter Unicel DXi800 (Woerden, the Netherlands) chemiluminescence assay completely and consistently recover added known quantities of FSH on top of a known basal serum FSH concentration?

Spiking-recovery experiment The investigators propose a spiking-recovery experiment in which 30 serum samples of different women with basal FSH concentration varying between 0-14 IU/L will be divided into two equal volume parts and spiked with a specific concentration of rFSH (Gonal-F, follitropin alpha; Merck Serono) which will provide a calculated rise in FSH concentration similar to in vivo serum levels.

To perform more reliable testing, the samples will be tested over multiple days.

Basal FSH spiking experiment In the table below an example is given of different basal FSH levels spiked with rFSH diluted 2000 times and the theoretical rise in serum that should be established.

Gonal F concentration is 600 U/L but this concentration unit cannot directly be compared to the units used for the for the routine serum FSH measurement (IU/L). From a pilot experiment the investigators know that on average 60% of rFSH is picked up by the Beckman-Coulter assay.

Buffer spiking In order to determine whether recovery is also influenced by properties of blood serum, the investigators will conduct another spiking experiment in which different concentrations of rFSH will be added to an amount of buffer, with no basal \[FSH\]; 0,1 M phosphate buffer, pH 7.4 with 1-2% of bovine serum albumin (BSA). A calibration line will be constructed with 6 concentrations of recF: range 0-40 U/L.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Basal FSH concentration varying between 0-14 IU/L

Exclusion Criteria:

* None
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin

To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period


Eligibility Criteria:
Inclusion Criteria:

* The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female \>=20 to \<80 years of age at Visit 1.
* The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP \>=140 mmHg and \<180 mmHg,
* LDL-C \>=140 mg/dL and \<250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).

Exclusion Criteria:

* Subjects who had experienced the following coronary artery disease within the past 3 months.
* Myocardial infarction
* Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting)
* Any clinically meaningful valvular disease
* Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.
Micromegaly and Discrepancy Between Growth Hormone and IGF1 at the Diagnosis and Follow-up of Acromegalic Patients

The diagnosis and the follow-up of acromegalic patients are based on the mesurement of Growth hormone (GH) and IGF1 rates. However, the literature described some cases of patient for whom the investigators observed a discrepancy between GH and IGF1 rates. Since the acromegaly is a rare disease and this phenomenon concerns about 30% of these patients, there is a lack of investigations about consequences that this discordance may induces. In this study, the investigators aimed at assessing if patients with discordance between GH and IGF1 rates present a different risk of recurrence and complications related to acromegaly, from patients with concordant results.


Eligibility Criteria:
Inclusion criteria:

* Acromegaly followed up in one of the center (Montpellier, Nimes or Béziers hospital, independent endocrinologist) between 2010 and 2021
* Age over 18 years old
* Measurement of GH and IGF1 rates at the last visit control available

Exclusion criteria:

* Lost to follow-up
* Status about complications related to acromegaly unknown
A Smoking Prevention Program (ASPIRE) and Mentoring for Preventing Smoking Among High School Youths

This early phase I trial studies how well A Smoking Prevention Interactive Experience (ASPIRE) program and mentorship works in preventing smoking in high school students. ASPIRE is an online-based, youth-centered tobacco prevention and cessation program. The goal of this research study is to learn if training eleventh grade high school students to be tobacco-free role models and mentors for ninth grade high school students is possible and will positively influence the younger peers.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of training selected eleventh grade high school student volunteers to provide an intervention involving mentoring combined with social support activities.

II. To increase ninth grade high school student well-being, which would ultimately influence tobacco related knowledge and resistance skills regarding tobacco uptake among ninth grade high school program participants.

EXPLORATORY OBJECTIVES:

I. Mentor ability, confidence, and intention (ACI) to address tobacco use and dependence and providing anti-tobacco advice to mentees.

II. To determine the scores on mentoring competencies. III. To determine the influences of social support and self-esteem by mentors. IV. To determine the quality and satisfaction with the relationships among mentors and mentees.

V. To determine level of knowledge about nicotine and tobacco products among mentees.

VI. To determine susceptibility to tobacco use among non-smokers. VII. To determine progression through stages of change among smokers.

OUTLINE:

Participants complete online ASPIRE course over 3.5-4 hours.

HIGH SCHOOL MENTORS: Eleventh grade high school students receive mentor training over 4-5 hours on how to mentor ninth grade students.

ALL STUDENTS: Mentors and mentees are paired up so that eleventh grade high school students mentor the ninth grade high school students over 30 minutes for 7 sessions about the different types of tobacco products (such as cigarettes, cigars, hookah, and so on) and the dangers of these products.

Eligibility Criteria:
Inclusion Criteria:

* Ages 13-18
* Enrolled in grades nine or eleven
* Speaks and understands English
* Parent or legally authorized guardian (LAR) provide written consent for study participation
* Student provides written assent for study participation

Exclusion Criteria

* Unable to speak and understand English
* Lives in the same household with another participant in the study
Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry

The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.

Pregnant women will be enrolled in the registry prospectively (after exposure to QIV in routine clinical settings but before knowledge of the pregnancy outcome). Women exposed to QIV with or without adverse events will be recorded in the Global Pharmacovigilance Database and medically reviewed. Pregnancy outcomes will be sought via questionnaires sent to the reporter at enrollment, estimated time of delivery, and six months after delivery. Descriptive statistical methods will be the primary approach for summarizing data.

No vaccine products will be provided or administered as part of this registry protocol.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women will be enrolled in the registry prospectively (after exposure to Quadrivalent Influenza Vaccine (QIV) but before the conduct of any prenatal tests that could provide knowledge of the outcome of pregnancy). If the condition of the fetus has already been assessed through prenatal testing (e.g., targeted ultrasound, amniocentesis, etc.), such reports will be considered retrospective reports. Retrospective reports are also eligible for the registry but they will be analyzed separately from prospective reports.

Exclusion Criteria:

* N/A
Long-Term Treatment Effect With Tildrakizumab in Participants With Plaque Psoriasis

The purpose of this study is to evaluate the psoriasis disease control over time in participants who had received Tildrakizumab for at least the last 5 years and have discontinued it and to describe blood and skin inflammatory biomarkers and its correlation disease relapse.


Eligibility Criteria:
Inclusion Criteria:

* Participants provide signed written informed consent prior to perform any study-related activity
* Participants has completed the long-term extension of the reSURFACE 2 study

Exclusion Criteria:

* Participants unable to comply with the requirements of the study
* Participants who in the opinion of the investigator should not participate in the study
Biomarkers Trajectories of Early Intervention in Siblings of Children with Autism Spectrum Disorder

This project deals with essential challenges in the context of Autism Spectrum Disorder benefiting from a prospective design in childhood, early intervention and a cutting-edge experimental techniques. The present study tests the potential effect of early intervention on neural and behavioral responses in toddlers at elevated likelihood of developing autism (siblings of children with autism) who show clinical autistic signs. Four comparison groups were included in the study: (1) toddlers at elevated likelihood of developing autism with clinical autistic signs who receive early intervention from 18 to 24 months (2) toddlers at elevated likelihood of developing autism with clinical autistic signs who do not receive early intervention (3) toddlers at elevated likelihood of developing autism without clinical autistic signs who only received assessment and monitoring, and (4) typically developing toddlers who only received assessment and monitoring.

This study focuses on social and nonsocial sensory integration skills (measured by electroencephalographic and eyetracking recordings) to identify reliable biomarkers for early detection and intervention of autism during a critical period of development.

The characterization of biomarkers will guide the detection of the most vulnerable children that will benefit from early intervention, with the long-term aim of reducing the impact of autism on the National Health System.


Eligibility Criteria:
Inclusion Criteria:

* Toddlers aged between 18 and 24 months
* Toddlers at elevated likelihood of developing autism, because siblings of children with a diagnosis of autism (for group 1, 2, and 3)

Exclusion Criteria:

* Gestational age \<36 weeks and/or birthweight \< 2000 grams
* Griffiths general quotient at 18 months \< 70
* presence of major complications in pregnancy and/or delivery likely to affect brain development
* presence of neurological deficits, dysmorphic markers, or other medical conditions.
Risk Factors for Morbidity After Parastomal Hernia Repair

The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DVHD to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after parastomal hernia repair.

All principal parastomal hernias registered in the Danish Ventral Hernia Database are included in the study. The included patients will be followed in up to 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

Eligibility Criteria:
Inclusion Criteria:

* All parastomal hernia repairs registered in the Danish National Ventral Hernia Database
Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

Patients in the intensive care unit are at risk for many infections because the severity of illness and the procedures necessary to care for them. This study is designed to look at a change in bathing procedure as a method to reduce infections. Currently, patients at John H. Stroger Hospital are cleansed with soap and water. However, preliminary data from a previous study at Rush University Medical Center showed that a chlorhexidine (CHG)-impregnated cloth (2% CHG Antiseptic Cloth system, Sage Products, Inc.) decreased skin bacteria and may lessen bacteria in the blood stream. The 2% CHG Antiseptic Cloth system is a non-irritating, no-rinse, cleansing and moisturizing product that contains 2% chlorhexidine gluconate. The goal of this proposed study is to further evaluate the effectiveness of the 2% CHG Antiseptic Cloth system compared with soap and water in cleansing the skin and preventing bacteria from entering the bloodstream.

Patients admitted to the medical intensive care unit at John H Stroger Hospital are randomly assigned to Unit A or B. Unit B was randomly selected as the intervention unit. For 6 months, all patients in Unit B will be bathed with the 2% CHG Antiseptic Cloth system and all patients in Unit A will receive soap and water baths. After this 6 month period, there will be a 2 to 4 week washout period and the interventions will cross over, with Unit A receiving Chlorhexidine baths and unit B receiving soap and water for 6 months.

Each week, two randomly selected patients will have cultures of the inguinal area, neck/subclavian region, and endotracheal aspirates. A comparison of the colonization of the skin and sputum will be done between the two intervention groups.

Daily infection surveillance will be done on all patients in the intensive care unit. A comparison of blood stream infections, clinical sepsis, and other nosocomial infections will be done between the two intervention groups.

Eligibility Criteria:
Inclusion Criteria:

* Data collection will be compiled from all the participants admitted to the Medical Intensive Care Unit (MICU).
* For skin cultures: One randomly selected (intubated or non-intubated) patient in each intervention group

Exclusion Criteria:

* Patients with greater than 20% of body surface area disruption in skin integrity will be excluded from participation in the 2% CHG Antiseptic Cloths arm of the study
A Study to Investigate the Safety, Efficacy and PK of Multiple Doses of QL-007 in Chronic Hepatitis B Patients in CHINA

This is a randomized, open-label, positive-control, dose-escalation Phase 1b trial in 60 patients with chronic HBV infection to determine the safety, preliminary efficacy, and pharmacokinetics (PK) of QL-007 after administration over 28 days of multiple oral doses in a fasted state at the following planned dose levels: 200, 400, and then 600 mg.

This is a randomized, open-label, positive-control, dose-escalation Phase 1b trial in 60 patients with chronic HBV infection to determine the safety, preliminary efficacy, and pharmacokinetics (PK) of QL-007 after administration over 28 days of multiple oral doses in a fasted state at the following planned dose levels: 200, 400, and then 600 mg.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Hepatitis B infection, defined as positive test for Hepatitis B surface antigen (HBsAg) for more than 6 months prior to randomization
* HBV DNA at screening greater than or equal to (\>/=) 2 × 10\^4 international units per milliliter (IU/mL) for Hepatitis B e antigen (HBeAg) positive participants, or \>/=2 × 10\^3 IU/mL for HBeAg-negative participants
* ALT\> 1 x upper limit of normal (ULN) and \< 10 x upper limit of normal (ULN)
* Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥4 weeks prior to screening are also eligible.
* Signed informed consent.

Exclusion Criteria:

* Known co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
* Presence of autoimmune disorders
* History of liver disease other than Hepatitis B
* History of Gilbert's Disease
* Any sign of decompensated liver disease
* Known or suspected cirrhosis
* Evidence of hepatocellular carcinoma
* Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months)
* Pregnant or lactating females
* Diabetes
* Alcohol or substance abuse
* History of bleeding diathesis
* Patients with a history of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator.
* History of clinically significant gastrointestinal, cardiovascular, endocrine, renal, ocular, pulmonary, psychiatric or neurological disease.