cyrilzakka/clinical-trials huggingface dataset:
Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis

The objective of the study is to evaluate the effect of spironolactone on 16 patients presenting with chronic non-resolutive central serous chorioretinitis (CSCR) and to evaluate whether spironolactone can resolve sub retinal fluid in these patients.

CSCR is a major cause of visual loss in the young population. It is characterized by sub retinal fluid under the retina and retinal pigment epithelial detachments. The exact causes of the disease remain unknown but a choroidopathy has been suggested. Moreover, corticotherapy and stress are known risk factors of CSCR.

Our preclinical studies have demonstrated that the mineralocorticoid pathway could be involved in the control of choroidal blood flow.

The investigators propose to evaluate the mineralocorticoid receptors antagonist spironolactone in the treatment of CSCR.

Criteria of efficacy Endpoint: reduction of subretinal fluid ≥ 40 microns Secondary endpoint: visual acuity gain ≥ 15 EDTRS letters

This is a prospective placebo controlled cross over study including 16 patients

Eligibility Criteria:
Inclusion Criteria:

* Patient between 18 and 60 years
* CSCR affecting the macula and non-resolutive for at least 3 months
* Patients having given and signed informed consent
* Vital prognosis non engaged for the next 6 months.

Exclusion Criteria:

* Other ocular pathology
* Neovascularization,
* Diabetes
* Uveitis
* Ocular surgery in the last 3 months
* Allergy to fluorescein or indocyanine green
* Pregnancy or no contraception
* Renal or liver insufficiency
* Kaliemia ≥ 5.5 mmol/l Criteria of efficacy
Relationship Between The Quadriceps Muscle Stiffness And Patellar Alignment For Healthy People

Patellofemoral pain is a common disease, and it often couples with patellar malalignment. Previously, imbalance of the different quadriceps muscle heads was believed to be a causative factor of patellar malignment. However, findings from electromyography studies on quadriceps activities and patellar alignment in the last two decades were inconsistent. In order to better understand the relationship between quadriceps muscle imbalance and patellar malalignment, shear wave elastography (SWE), which can measure the passive and active muscle stiffness, may shed some new lights to this area. This study aims to examine whether the quadriceps muscle stiffness can predict the patellar position. The healthy young adult will be recruited in this study. Active and passive quadriceps muscle stiffness will be measured with the SWE in different conditions and the result will be correlated with the patellar position measured with magnetic resonance imaging (MRI). Also, electromyography (EMG) activity will be measured during the active stiffness measurement so as to establish the level of agreement between the EMG and SWE data. Linear regression will be used to calculate the relationship between different factors. The total number of subjects needed will be 55 by setting an effect size of 0.15 with two predictors, 80% power, and α at 0.05 in the linear regression.

This project will be conducted at PolyU campus and an MRI clinic in Hong Kong. Hopefully, it could be started in July 2021 and will last for 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and in the range between 18 and 45 years.

Exclusion Criteria:

* Knee pain in the last 3 months;
* Previous history of knee surgery;
* People with contraindications to having MRI scanning.
LBBAP Data Collection Registry

The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.

This registry is a retrospective, observational, non-controlled chart review conducted to support an indication expansion of the Tendril STS 2088 lead to include pacing/sensing in the left bundle branch area.

Data from a minimum of 220 attempted subjects will be included in order to have 190 evaluable subjects in this registry. The chart review will be conducted at up to 20 participating centers worldwide.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has a de novo attempted implant of the TendrilTM STS 2088 lead in the Left Bundle Branch Area on or before January 31, 2023 and subject's medical records contain data through at least 6 months (+/- 3 months) after LBBAP implant attempt
2. Subject is ≥ 18 years of age or the legal age, whichever age is greater
3. For sites where the governing IRB/EC has not granted a waiver of informed consent, subject has either been informed of the nature of the clinical investigation using a privacy notice or has provided a signed written informed consent, as approved by the IRB/EC (Note: This inclusion criterion is not applicable for sites where the governing IRB/EC or applicable regulation has granted a waiver of patient consent)

Exclusion Criteria:

1. Subject was enrolled in another clinical trial during this data collection period that might impact the outcomes of the present registry
Modification of Endometrial Receptivity After Vaginal Seminal Plasma Application

The aim of the project is to investigate the effect of seminal plasma on the endometrium and to evaluate changes in the endometrial receptivity after exposure to seminal plasma.

Implantation is still an important limiting factor for the improvement of pregnancy rate in the Assisted Reproductive Technology (ART). Usually, in fertility clinics, only the spermatozoa are used for the treatments while the rest of the seminal fluid is discarded. However, the importance of seminal fluid in fertility has gained interest in the last years but no conclusive that has been obtained yet.

Experimental group:

We decided to focus our attention on lesbian couples and single women undergoing ART procedures because they could benefice the most from this treatment since they usually do not have contact with seminal plasma. Moreover, to the best of our knowledge, they have more problems in achieving a pregnancy than heterosexual couples. Our observation is supported by a preliminary analysis of data from the Dansk fertilitetsselskab.

Design Randomized, double-blinded, placebo-controlled study

* Group 1 treated: 20 healthy lesbian or single women receiving assisted reproduction
* Group 2 control: 20 healthy lesbian or single women receiving assisted reproduction

Treatment

* One month before the IVF procedure: First seminal plasma/placebo application during ovulation period
* Same month of the IVF procedure: second seminal plasma/placebo application after ovum pick up

  5 days after the first application an endometrial biopsy and one blood sample will be taken for analysis.

Analysis:

Endometrial transcriptome microarray analysis that will be verified through protein analysis.

Differences in the transcriptome between the two groups will be compared with data in literature for an optimal endometrial receptivity. Moreover, clinical pregnancy rate and pregnancy outcome will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Healthy lesbian and single women receiving IVF assisted reproduction treatment at OUH Fertility Clinic

Exclusion Criteria:

* Language problems to such an extent that subjects do not understand the scope of the study.
* Abnormal high follicle-stimulating hormone
* severe endometriosis,
* severe polycystic ovarian syndrome
* chronic diseases
Prospective Validation Study of High Volume Urine DNA Testing in Individuals with Suspicion of Urothelial Cancer

Urothelial cancers of the bladder and upper urinary tract account for over 200,000 deaths and 600,000 diagnoses annually worldwide. The most common presenting symptom is hematuria (blood in urine), triggering a cascade of tests, including an invasive examination of the bladder using a flexible scope (cystoscopy). Millions of cystoscopies are performed every year worldwide for patients presenting with hematuria, but only 10% result in a cancer diagnosis. The UROSCOUT-1 trial is a prospective multicenter observational study that explores the potential of urine tumor DNA (utDNA) testing to replace a significant portion of cystoscopies in the diagnostic setting for hematuria or other reasons to rule out urothelial cancer. The goal is to enhance patient quality of life, reduce healthcare costs, and address increased workloads in urology centers. Sample collection will be conducted by mail, and the samples will be analyzed in a blinded manner, without knowledge of which patients are diagnosed with cancer. Random subsampling will be applied to cancer-negative patients to achieve an approximate 1:1 ratio between cancer-positive and -negative patients.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Patient has been scheduled for cystoscopy to rule out urothelial cancer

Exclusion Criteria:

* Prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)
Telerehabilitation for Visually Impaired

the purpose of the study is to evaluate the software usability and patient's adherence from five vision rehabilitation centres. In addition, the effect and benefits of a customizable telerehabilitation program were tested.

The software is used in our practice for every day vision rehabilitation training.

So it is part of our routine medical care, and a we are going to study studies the effect of the intervention in several different centers.

Eligibility Criteria:
Inclusion Criteria:

* All patients were eligible if they were over 18 years old and had a best corrected visual acuity (BCVA) between 1.3 logMAR and 0.4 LogMAR and/or a visual field of less than 60%, according to the WHO classification.

Exclusion Criteria:

* Subjects were excluded if they had a cognitive/psychiatric impairment or a motor disability that prevents the use of a computer pointing device (mouse).
Effects of Early Time Restricted Eating on Muscle Performance in Resistance Trained Individuals

A randomized controlled trial to determine the effectiveness of early time-restricted eating on muscle performance and body composition in active, resistance trained adults. Two parallel groups will be randomly assigned to either the early time-restricted eating or a control group. All participants will be asked to maintain their usual exercise routines during the 6 week intervention period. Muscle strength and endurance are the primary outcomes. Body composition (body weight, fat mass, fat-free mass and percent body fat), hunger and satiety ratings, sleep quality, energy intake, diet quality, macronutrient composition and adherence are secondary outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 - 50 years
* Performing resistance training at least twice per week (for ≥1 yr)
* BMI ≥ 18.5

Exclusion Criteria:

* Currently sedentary or not engaged in resistance training.
* Major surgeries in muscles/joints during the past 3 months
* BMI \< 18.5
* Ineligible to engage in physical activity according to 2022 Physical Activity Readiness Questionnaire for everyone (PAR-Q+)
* Take anabolic steroids or on hormone replacement therapy.
* Current smoker.
* Following restrictive diets (Vegan, vegetarian, intermittent fasting, Paleo, calorie restriction, keto/ low carbohydrate diet or any other restrictive diets)
* Active cancer or cancer requiring treatment in the past 2 years (except non-melanoma skin cancer).
* Musculoskeletal disorders
* Diagnosed with cardiovascular disease including myocardial infarction, heart surgery, heart failure and had a heart transplant.
* Have pacemaker or metal implants
* Diagnosed diabetes (type 1 or 2).
* Diagnosed hypertension or high blood pressure (\>130/90).
* Diagnosed eating disorder or score ≥ 20 on Eating Attitudes Test -26 (EAT26) survey
* Missing limbs/ have prosthetics
* Had surgery in joints/muscle in the past year.
* Received medical advise against exercising due to medical reasons.
* On medication for conditions related to the thyroid gland
* Unwilling to commit for a 7-week study
* Likely to move away from participating clinic before trial completed
* Unable or unwilling to give informed consent
* Another household member is a participant or staff member in the trial
* Unwilling to accept treatment assignment by randomization
* Current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial
* Pregnant or \< 6 months since giving birth.
* Any other condition which, in opinion of investigators, that would adversely affect conduct of the trial.
Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to IUD Insertion

This prospective, open label, double arm, feasibility group study will recruit participants planning to undergo office intrauterine device (IUD) placement without sedation or anxiolysis at the Center for Women's Health. Participants will self-administer a topical anesthetic using a contraceptive cervical cap or menstrual disc.

Twenty-four nulliparous women will be recruited to receive one of two administration methods immediately prior to IUD placement (12 subjects in each arm): 1) menstrual disc filled with 5g eutectic mixture of local anesthetics (EMLA) cream or 2) cervical cap filled with 5g EMLA cream.

Nulliparous patients undergoing IUD insertion will administer EMLA cream by menstrual disc or cervical cap prior to insertion. The medical provider will ensure proper placement of the cap or disc and perform a bi-manual exam to assess the patient's uterine position. A seven minute timer will be set, the cap/disc will be removed, and the provider will proceed with the IUD insertion according to manufacturer technique.

Visual Analog Scale (VAS) scores will be used throughout the procedure to assess participant pain throughout insertion. Participants and providers will report on pain, side effects, and procedure complications immediately after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for IUD placement at the Center for Women's Health in Complex Family Planning clinic
* Able to review and sign study consents in English
* Generally healthy

Exclusion Criteria:

* History of any prior births, miscarriages, or abortions after 16 weeks' gestation
* Currently pregnant, known or suspected
* Current stringless IUD in place
* Participants premedicated with misoprostol
* History of chronic pelvic pain which patients take daily medication for
* History of endometriosis, fibroids, adenomyosis, prior cervical procedures (such as Loop Electrosurgical Excision Procedure (LEEP) or cold knife cone)
* Any contraindications to IUD placement (per current labeling including pregnancy, fibroids that distort the uterine cavity, exam consistent with pelvic inflammatory disease, allergy to any component of the levonorgestrel intrauterine system (LNG-IUS), etc.)
* Known allergy to eutectic mixture of local anesthetics (EMLA) or lidocaine cream, silicone, menstrual disc, or cervical cap
* Any contraindication to EMLA or lidocaine cream, menstrual disc, or cervical cap
* Previous IUD placement or failed attempt of an IUD placement
* Weight \< 54.4kg (120 lbs)
* Plan for use of oral anxiolysis, moderate/deep sedation, or narcotics for procedure
* Patient requesting or patient use in the past 24 hours of oral anxiolysis, moderate/deep sedation, or narcotics
* Any planned concomitant procedures, such as dilation and curettage (D\&C), endometrial biopsy, colposcopy, hysteroscopy, etc.
* Illicit drug use
Study of the Effect of SR57667B on 18F-Dopa PET Imaging in Patients With Parkinson's Disease

* The primary objective is to study the effect of SR57667B at the dose of 4 mg/d on progression of dopaminergic nigro-striatal lesions assessed by 18F-Dopa PET imaging.
* Secondary objectives are to assess the effect of SR57667B on symptomatic decline in patients with early PD, to assess the safety/tolerability of SR57667B in patients with early PD and to document plasma concentrations of SR57667 in patients with early PD.

Multinational, multicenter, randomized, parallel-group, double-blind, phase II study.Randomization stratified on the dopaminergic treatment, in two strata: treatment by levodopa or dopamine agonist.

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients.
* Age \>=35 years at screening.
* Diagnosis of Parkinson's syndrome, on at least two of the three key Parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity.
* Duration of the disease of less than 3 years since diagnosis.
* Modified Hoehn and Yahr stage \<= 2.5.
* Patient optimized on monotherapy by levodopa or a dopamine agonist·
* Generally healthy and ambulatory.
* Patient has given his informed written consent and is capable of following study procedures.

Exclusion Criteria:

* Any indication of forms of parkinsonism other than PD.
* Severe resting tremor. Presence of either dyskinesia, fluctuations, or loss of postural reflexes·
* Treatment with amantadine, anticholinergics, catechol-o-methyltransferase (COMT ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa. Electroconvulsive therapy (ECT).Use of CYP3A4 strong, and moderate inducers or inhibitors. Participation in another clinical trial with an investigational drug within two months prior to randomization.
* Dementia, uncontrolled depression, psychotic disorder. History of substance-related disorders including alcohol or other substance use disorders.
* Females of child bearing potential.
* Evidence (detected by history, physical examination and/or laboratory/ECG tests) of any clinically significant or unstable medical disorder that could interfere with the patient's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. Alterations of laboratory tests or ECG findings of potential clinical significance.
Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C

The aim of this study is to prove the efficacy of peginterferon in HIV infected patients with liver disease caused by hepatitis C virus (HCV) when the treatment to eradicate the virus failed. This scientific proof needs a comparative study to be done including two groups of patients randomly allocated: one with the treatment (peginterferon) and the other without any treatment against HCV with a duration of 2 years. To conclude, two liver biopsies are needed; one before the study and a second 2 years after.

C hepatitis in HIV infected patient becomes a major issue although the survival of patients, has improved in the last decades regarding to the advent of HAART, the mortality related to liver disease has increased in this population. Sustained virological response for HCV can be obtained with peg-interferon and ribavirin treatment but more or less 50% of patients experienced failure to this treatment and liver fibrosis due to HCV infection progress and may lead to cirrhosis and hepato-carcinoma. To demonstrate the efficacy of peginterferon therapy to reduce the liver damage causes by HCV infection, a randomised controlled study is needed comparing one group of patient treated by peginterferon and one group without any treatment against HCV infection. In order to show 30% difference between the two groups in reducing one point of fibrosis score (METAVIR scale), 150 patients are needed. The duration of the study is 96 weeks

Eligibility Criteria:
Inclusion Criteria:

* HIV infection (Western Blot +)
* C hepatitis (RNA viral hepatitis C \[VHC\] +)
* Chronic active C hepatitis on liver histological score METAVIR (A over or equal to 1 and F over or equal to 2) on biopsy performed at least 18 months before the expected date of inclusion
* Previous treatment for C hepatitis for at least 3 months including peg-interferon and ribavirin or peg-interferon alone if counterindication for ribavirin occurred
* Failure to eradicate C hepatitis virus after well conducted treatment
* The liver biopsy should have been realised at least 18 months before inclusion :

Either before treatment for C hepatitis in patients treated at most 7 months Or at least 6 months after anti HCV treatment in patient treated for more than 7 months (wash out period)

* Regular follow up in an outpatient clinic for HIV
* Unchanged antiretroviral treatment the last 3 months before inclusion
* Inform consent

Exclusion Criteria:

* History of transplantation or clinical hepatic failure
* Opportunistic infection in the past three months before inclusion
* Any hepatic disease not related to HCV (B hepatitis, hemochromatosis, Wilson disease)
* Diabetes mellitus
* Immunocompromised treatment
* Active intravenous drug addiction
* Alcohol consumption of more than 50 g per day
* Counterindication for the use of interferon
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers

The purpose of the study is to collect different samples for molecular characterization of inflammatory skin diseases.

This study is being conducted to collect samples from subjects with various skin conditions as well as healthy volunteers. Collected samples may be used for different analyses including, but not limited to, biomarker and gene expression analyses.

Eligibility Criteria:
Inclusion Criteria:

All subjects:

1. Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
2. Subject must be willing to comply with all study procedures and must be available for the duration of the study.

   Healthy volunteers:
3. Male or female subject aged 18 years or older, at the time of consent.
4. Subject is in good general health, according to the investigator's judgment.

   Subjects with Acne:
5. Male or female subject aged 18 to 45 years old, inclusive, at the time of consent.

   Subjects with AD:
6. Male or female subject aged 18 years or older, at the time of consent.
7. Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.

   Subjects with CHE:
8. Male or female subject aged 18 years or older, at the time of consent.
9. Subject has at least a 6-month history of CHE before Screening (information obtained from medical chart or subject's physician, or directly from the subject).

   Subjects with HS:
10. Male or female subject aged 18 years or older, at the time of consent.
11. Subject has a clinically confirmed diagnosis of active HS with a disease duration of ≥ 6 months before screening as determined by the investigator through subject interview and/or review of the medical history.

    Subjects with PPP:
12. Male or female subject aged 18 years or older at the time of consent.
13. Subject has at least a 6-month history of PPP as defined by the presence of pustules on palms and/or soles, but without evidence of infection on palms and soles (information obtained from medical chart or subject's physician, or directly from the subject).

    Subjects with psoriasis:
14. Male or female subject aged 18 years or older, at the time of consent.

Exclusion Criteria:

All subjects:

1. Subject is a female who is pregnant or who is planning to become pregnant during the study.
2. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.