cyrilzakka/clinical-trials huggingface dataset:
Comparing Efficacy and Safety of Inhaled SNG001 to Placebo

When people with asthma get respiratory virus such as a cold or flu it often increases asthma symptoms. The investigators will test the study medication to find out if it can prevent the virus spreading from the nose to the lungs.

SNG001 contains Interferon-beta that occurs naturally in the body. In this study, SNG001 will be given by a nebuliser.

The study will consist of a Pre-Treatment Phase into which subjects potentially eligible for the Treatment Phase will be recruited. Subjects will remain in the Pre-Treatment Phase until they experience respiratory virus symptoms at which time they will be further screened for eligibility for entry into the Treatment Phase. If eligible, subjects will be randomised 1:1 to receive SNG001 or placebo once daily for 14 days. Doses will be delivered by a CE marked breath actuated nebuliser (I-neb Philips Respironics). Subjects will be assessed for changes in changes in respiratory virus symptoms and asthma symptoms at home using a text message system, and via telephone questionnaire. Lung function will be measured both at home by the subjects (PEFR only) and in the clinic. Efficacy and safety will be monitored until at least 30 days post treatment.

Eligibility Criteria:
1. Male or female aged 18 to 65 years of age at the time of screening.
2. Symptoms of asthma for at least 2 years pri or to the Screening Visit, confirmed by a medical history and:

   1. ≥12% and 200mL bronchodilator reversibility at screening or documented in the past, OR,
   2. evidence of bronchial hyper-responsiveness at screening or documented in the past, OR,
   3. a documented hospital admission (including an Accident and Emergency admission) for asthma since the age of 18, OR.
   4. documented evidence that they have attended their GP surgery, out-of-hours clinic (or alternative health care provider) for worsening of asthma symptoms, since the age of 18
3. Must answer "Yes" to the question "Does a cold make your asthma worse?"
4. To have had at least one asthma exacerbation suspected to have been caused by a respiratory virus in the last 24 months which required the use of oral steroids and/or additional treatment with antibiotics on one or more occasion.
5. Must be taking regular inhaled corticosteroids.
6. Pre-bronchodilator FEV1 ≥ 40 % predicted at screening.
7. Post-bronchodilator FEV1 ≥ 50 % predicted at screening.
8. Provide written informed consent.
9. Females of childbearing potential must be using a medically acceptable adequate form of birth control and agree to maintain this usage throughout the duration of and four weeks post the Treatment Phase of the study.
10. Motivation (in the Investigator"s opinion) to complete all study visits, the ability to communicate well with the Investigator and be capable of understanding the nature of the research and its treatment including its risks and benefits.
PROMUS PREMIER™ China Post-Approval Study

To compile real-world clinical outcome data for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System (Promus PREMIERTM Stent System) in routine clinical practice in China.

Each site will be allowed to enroll up to a maximum of 300 subjects. The scheduled follow up will occur at 30 days, 6 months, 12 months and then annually through 5 years post stent implant, for all enrolled subjects. Follow-up will be conducted via telephone contact or clinic visit

Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 18 years of age
* Subject understands and provides written informed consent
* Subject who is clinically indicated and will have an attempt of at least one Promus PREMIERTM Stent OR Subject who is clinically indicated and was implanted with at least one Promus PREMIERTM Stent
* Subject is willing to comply with all protocol-required follow-up evaluation

Exclusion Criteria:

* Exclusion criteria are not required in the PE PREMIERTM China Post-Approval Study which is an "all comers" study.
How Does the Mood of the Patients Change Before and After the Invasive Urodynamic Study?

The goal of this study is to learn about the patient's perspective regarding to psychological mood before and after an invasive urodynamic study.

The participants have already had an indication of an invasive urodynamic study. All patients will be given STAI, perceived stress scale and VAS forms just before, after and 1-week following an invasive urodynamic study. The scores will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an invasive urodynamic study indication

Exclusion Criteria:

* Non-Turkish speakers
* Poor conscious state
Stiffness of the Skin and Joints in Relation to Carpal Tunnel Syndrome

The exact etiology of CTS remains yet unknown. A rise in carpal tunnel pressure is well documented, but why this phenomenon occurs is yet unknown in most patients. There is an absolute or relative narrowing of the carpal tunnel, which results in a compression of the median nerve.

The investigators postulate, that a stiffer flexor retinaculum (roof of carpal tunnel) will be less compliant. As a consequence of this stiffer retinaculum the pressure in the carpal tunnel will rise more quickly in stiff patients resulting in CTS-complaints.

A relation between connective tissue composition and joint stiffness is proven. This relationship possibly extends to a relation between stiffness of the skin, joint stiffness and the prevalence of CTS.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* Carpal tunnel release OR Trigger finger OR Dupuytren OR an acute trauma to the hand

Exclusion Criteria:

* Hypo-/hyperthyroidism
* Diabetes
* Arthritis
* Pregnancy
* Obesity (BMI \>30)
* Anatomical anomalies
Study to Improve Partner Services for STD Prevention

The goal of this study was to examine the efficacy of patient-delivered partner treatment (PDPT) compared to standard partner referral (PR) and booklet enhanced partner referral (BEPR).

For partner treatment, index women who were diagnosed with trichomonas vaginalis and index men who were diagnosed with urethritis were randomized to one of three study arms:

Standard partner referral (PR) - index patients were instructed to tell their partners that they need to go to a clinic for STI evaluation and treatment.

Booklet-enhanced partner referral (BEPR) - index patients were given a wallet-sized booklet containing 4 tear-out cards with information for the partner and treatment guidelines for the providers that would see the partners. The partners could then present this card at a clinic to help the clinician better treat them. If index patients had more than 4 partners, they were given additional booklets.

Patient delivered partner treatment (PDPT) - index patients were given packages containing 2 gram metronidazole (for TV patients) or azithromycin 1 gram and cefixime 400 mg (for urethritis patients) for up to 4 identified sex partners. When cefixime was no longer available, ciprofloxacin 500 mg was used. These packages contained written instructions about how to take the medication, warnings about side effects and a nurse's pager number to call if there were any questions or if the partner encountered any problems. All medications were distributed in containers with childproof caps and the partner's initial and birthdates were written on the bottle. This was a requirement of the Louisiana State Pharmacy Board. Names were not documented on the index patient's study or medical records.

Eligibility Criteria:
Inclusion Criteria:

* Woman attending Family Planning Clinic or men attending STD clinic
* Aged 16-44
* (non-pregnant women) - positive InPouch for trichomonas, or
* (pregnant women) - positive wet mount or InPouch for Trichomonas vaginalis
* (men) a complaint of urethritis which is verified on examination
* Report having \>= 1sex partners in past 60 days
* Not presumptively treated for trichomonas (women) or urethritis (men)
* Provide informed consent to be re-contacted by telephone or in person in 14-28 days for a follow-up interview and T vaginalis or CT/GC rescreening

Exclusion Criteria:

Men

* Prisoner
* Has taken cefixime or azithromycin in last two weeks
* Has previously participated in the study
* All female partners are pregnant and did not have male partners Women
* client has taken metronidazole in the last two weeks
* client has been in this study previously
* women who are asymptomatic and in their first trimester of pregnancy
Role of Methylation Test Triage in HPV Positive Women

The pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status (ASTN1 DLX1, ITGA4, RXFP3, SOX17, ZNF671) in triaging high-risk human papillomavirus infection. The sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening.

The study is divided into two phases, a baseline (cross-sectional) phase and a 1-year follow-up phase. Women who meet the clinical endpoint (i.e. histopathologically confirmed ≥CIN2 after baseline colposcopy/biopsy) are withdrawn from the study. Participants who do not meet the primary endpoint/treat at baseline will invited to participate in the follow-up phase of the trial. Participants included in the follow-up phase are underwent HPV, cytology, and methylation tests at 6 months and 1 year after baseline.Similar to the baseline phase,participants were referred to colposcopy/biopsy if any of the cytology and HPV tests result is positive.

Eligibility Criteria:
Inclusion Criteria:

* aged 25\~65 years undergoing cervical cancer screening
* normal for cytology and positive for hrHPV
* informed consent was obtained

Exclusion Criteria:

* pregnant
* with a known history of ablation or treatment with cervical excision within 12 months
* hysterectomy
* chemoradiotherapy
* planning to participate or taking part in another cancer screening, treatment, or vaccination study
* do not meet the inclusion criteria
* give up the trial or naturally dropped out of the follow-up during the observation process
* people who asked to withdraw
Cognitive Function in Patients With Persisted Atrial Fibrillation

Compare the difference of cognitive function between different treatment strategy in patients with persistent atrial fibrillation

The prevalence of atrial fibrillation (AF) had been increasing for the past decade. The increase of AF was attributed to the aging of the population and the increased awareness of the disease among people and the primary physicians. However, we have not achieved the consensus whether aggressive rhythm control or conservative rate control is better in a patient with asymptomatic persisted AF. We do prescribe anti-coagulant for stroke prevention, but which treatment strategy is best for the patients is uncertain.

The clinical trial of catheter-based ablation for rhythm control compared to traditional medication control has not shown the benefit of reducing all-cause mortality, but it did show a reduction of re-hospitalization and the recurrence of AF. On the contrary, the study in heart failure patients had shown a significant benefit applying catheter-based rhythm control strategy to reduce all-cause mortality. The different results of these two trials told us the benefit of rhythm control is not easily to be seen in a short-term, but could be seen in a long term or in high risk patients. The association between AF and cognitive impairment has also been reported in observation cohort. However, there is no sold evidence in clinical trials to show the improvement of cognitive function by treating atrial fibrillation. One study did show improvement of cognitive function with questionnaire, but the other showed new lesion detected by traditional magnetic resonance imaging (MRI) after ablation, though the lesion resolved after one year of follow-up. There is no clear answer to which treatment strategy is better for the patients' cognitive function。 Therefore, we designe a prospective, randomized, blind endpointtrial. We will enroll the patients with persisted AF, and use advanced MRI (DTI/SWI) and questionnaire to longitudinally study the cognitive function change of the patients before and after the initiation of anti-coagulant agents, before and after the catheter-based ablation, and use this as a surrogate to understand the best treatment strategy for these AF patients.

Eligibility Criteria:
Inclusion Criteria:

1. Those who meet the diagnosis of persistent atrial fibrillation, meet one of the following conditions:

   * The twelve-lead electrocardiogram is used to diagnose atrial fibrillation, and to cooperate with clinical diagnosis.
   * 24 hours ECG diagnosis 100% atrial fibrillation, with clinical diagnosis.
   * The seven-day ECG recorder diagnosed 100% atrial fibrillation.
2. Willing to accept treatment recommended by doctors, containing anticoagulant, and cooperate with examination and treatment in the coming year.

Exclusion Criteria:

1. Unwilling to sign the clinical trial consent form.
2. Unable to complete the cognitive function questionnaire.
3. Unable to complete brain MRI examination due to various reasons
BEOVU in the Treatment of Dystrophy-related Macular Neovascular Degeneration

Dystrophy-Related macular neovascularization degeneration occur is a vision threatening condition.The investigators evaluate the efficacy of BEOVU intravitreal treatment.

Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done.

Procedure included intravitreal injection of Brolucizumab (BEOVU®, Genen-tech, South Francisco, CA)

Eligibility Criteria:
Inclusion Criteria:

* Dystrophy-Related macular neovascularization degeneration

Exclusion Criteria:

* age related macular degeneration , other causes of macular neovascularization degeneration
US-CT Fusion for Post Implant Dosimetry

Post implant dosimetry is an essential part of quality assurance after permanent seed prostate brachytherapy. CT imaging is the standard of assessment but due to contouring uncertainties, MR-CT fusion is preferred. This is not always available due to financial restrictions. This study explores the possibility of post implant US-CT fusion to improve contouring accuracy and potentially replace the use of MR-CT fusion.

25 participants undergoing permanent seed prostate brachytherapy will be approached to undergo collection of prostate US images at the completion of their procedure. This will add approximately 5 minutes to the duration of their brachytherapy procedure. The US study will not entail any discomfort or risk to participants as they are still under anesthesia for the implant procedure. The institution standard of care for quality assurance will be complied with, obtaining a CT and MRI of the prostate at 30 days after the procedure. These will be co-registered and analyzed in the normal fashion. In addition, the post implant US images will also be co-registered with the CT and the resulting dosimetric parameters compared.

Eligibility Criteria:
Inclusion Criteria:

* localized prostate cancer suitable for permanent seed implant brachytherapy as either monotherapy or as a boost

Exclusion Criteria:

* Unable to undergo MRI
Randomized Controlled Study Comparing Colon Evaluation With The Pure-Vu System To A Standard Colonoscopy In Patients Who Are High Risk For Inadequate Bowel Preparation

The primary objective of this multi-center, prospective, randomized controlled trial is to evaluate the bowel cleansing after Pure-Vu use in outpatient subjects at high risk for inadequate colon preparation as compare to standard of care.

Total of 88 subjects (44 per arm) at high risk for inadequate colon preparation will be randomized and undergo procedure either in the Control arm (standard of care) or with the Pure-Vu System.

Subjects will be enrolled at up to 4 clinical sites in the United States.

primary endpoint- A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS \>2 in each segment)

The following secondary endpoints will be determined:

1. Assess the willingness of consented subjects to pay for Pure-Vu prior to colonoscopy
2. Colonoscopy procedural measures for Intervention and Control arms
3. Endoscopists' experience
4. Safety assessment for all subjects on the day of procedure per endoscopist
5. Post-colonoscopy patient experience and safety check with scripted phone call 1-3 days after colonoscopy
6. Assess the willingness of consented subjects to pay for the Pure-Vu System 1-3 days after colonoscopy

Follow-up call will be conducted 1-3 business days after the procedure to verify that there has been no change in their clinical status and record their willingness to use the Pure-Vu System in the future.

Eligibility Criteria:
Inclusion Criteria:

1. Adults \> age 22
2. Elective outpatient colonoscopy by participating gastroenterologist
3. Stool clarity grade 1-3 at presentation for colonoscopy

Exclusion Criteria:

1. Not competent to consent
2. Bleeding disorder - known or suspected
3. Hereditary Gastrointestinal Cancer syndrome
4. Known PT INR \> 1.5
5. Know elevated PTT
6. Anti-platelet agent or anticoagulant (other than aspirin or nonsteroidal agent) which has not been stopped for the colonoscopy
7. Known platelet count \< 50,000
8. Known absolute neutrophil count \< 1,000
9. History of surgical colon resection
10. Pre-colonoscopy intent to enter terminal ileum
11. Prior incomplete colonoscopy due to technical \& non-bowel preparation related reasons
12. Regular use of non-topical steroid
13. Pregnant
14. Prisoner or institutionalized for any reason
15. Psychiatric illness greater than mild
16. Colonoscopy without anesthesia administered (MAC) sedation
17. Diverticulitis
18. Active inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)
19. Known or suspected colon stricture
Hydrogen-Rich Water and Exercise-Related Biomarkers in Men and Women Over 50 Years

The study investigates the impact of consuming hydrogen-rich water over a six-week period on exercise-related biomarkers among individuals aged over 50, both men and women, who undergo a resistance training program. This research aims to discern the potential benefits of hydrogen-infused water consumption concerning exercise-related markers in an aging demographic post-resistance training.


Eligibility Criteria:
Inclusion Criteria:

* Age 50 - 65 years (at least 50% would be over 60 years)
* Body mass index 18.5 - 29.9 kg/m2
* Free of major chronic diseases or acute disorders
* Resistance exercise naïve (no resistance traiing during 6 months before study commences)

Exclusion Criteria:

* History of dietary supplement use during the 4 weeks before study commences
* Unwillingness to return for follow-up analysis
Risk of Recurrence of Cervical Artery Dissection During Pregnancy and Puerperium

Cervical artery dissection (CAD) accounts for about 2% of all strokes, and is a major cause of stroke in young people (about 15%). Many cases of CAD during pregnancy and puerperium have been described, suggesting that pregnancy and puerperium may be potential risk factors for CAD. The purpose of this study is to determine whether pregnancy and puerperium are also recurrence risk factors for CAD.

In this study, all women of childbearing age who had had a CAD between 2005 and 2017 are selected. Women are identified using the ICD10 diagnostic coding system. In addition, a text search with key words ("cervical or carotid or vertebral dissection") has been created in a data warehouse of the University Hospital of Nantes.

To determine the recurrence of CAD during pregnancy and puerperium, the participating women will be asked to answer to a questionnaire, by phone or mail. The questionnaire will be conducted by the same investigator, an experienced neurologist. Information about recurrence of CAD, number of pregnancies before and after the event will be recorded, as well as, the site of obstetrical monitoring, way of delivery, and management of antithrombotics, in case of further pregnancy. In case of no further pregnancy after the dissection, the reason will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Extracranial carotid or vertebral dissection
* Symptomatic dissection (with symptom onset within the last four weeks)
* Spontaneous dissection
* Imaging evidence of dissection on MRI/MRA, CTA or ultrasound.

Exclusion Criteria:

* Minors or adults under guardianship
* Intracranial artery dissection
* Traumatic or iatrogenic dissection
* Patient refusal to participate
Contralateral Testicular Volume in Unilateral Impalpable Testis

This prospective interventional study aimed at the preoperative sonographic estimation of the testicular volume of the normal side in case of contralateral impalpable maldescended testis in order to predict the condition of the diseased side and hence the need for diagnostic laparoscopy.

Purpose: This study aimed at the evaluation of the value of the estimated volume of a normal testis to predict the status of its contralateral impalpable side and hence decide the importance of laparoscopic exploration. Material \& methods: Patients with unilateral impalpable maldescended testis - as confirmed by clinical and sonographic examination- were enrolled in this prospective interventional study between November 2018 and August 2022 at Elshatby University Hospital, Faculty of Medicine, Alexandria University. The volume and three-dimensional diameter of the normal contralateral testis were measured by the pre-operative US using the formula: Volume = L x W x H x π/6, where L is the length, W is the width, H is the height, and was correlated with the intra-operative laparoscopic findings.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with unilateral impalpable maldescended testis

Exclusion Criteria:

* Patients with bilateral impalpable maldescended testis and those with post-operative ascended testis