cyrilzakka/clinical-trials huggingface dataset:
Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery

This clinical study is a prospective, post-market-clinical-follow-up study to investigate the long-term (3 months) safety of femtosecond laser assisted cataract surgery as a study follow-up extension to the Study #1304 titled as "A Multi-centre, Multi-surgeon, Randomized, Controlled, Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Impact of Cataract Grade on the Efficacy and Safety of Femtosecond-laser Assisted Lens Fragmentation Procedure".


Eligibility Criteria:
Only the patients who were successfully enrolled in Study #1304 are eligible for this follow-up extension study.
Extension Study of MT-1303

To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).


Eligibility Criteria:
Inclusion Criteria:

* Completion of the 24-week treatment period in MT-1303-E04 as per protocol
* Able to provide written informed consent and to comply with the requirements of the protocol
* For males and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.

Exclusion Criteria:

* Permanent discontinuation of study medication prior to the end of treatment (EOT) visit in MT-1303-E04
* Newly diagnosed diabetes mellitus during MT-1303-E04
Auricular Acupuncture in Postoperative Pain

The effect of acupuncture for postoperative pain control remains controversial. We therefore studied the effects of electrical auricular acupuncture (AA) on postoperative opioid consumption in a randomized, patient-blinded clinical trial.

40 female patients undergoing laparoscopy were included. Anaesthetized patients were randomly assigned to receive AA (shen men, thalamus and one segmental organ-specific point) or electrodes and electrical stimulation for 72 hours. Postoperatively patients received 1 g paracetamol every 6 hours and additional piritramide on demand. A blinded observer obtained the doses of piritramide and the visual analogue pain scores (VAS) at 0, 2, 24, 48, and 72 hours.

It was the aim of our study to find out, whether auricular acupuncture reduces postoperative pain.

Postoperative pain treatment is a major issue in management of surgical patients. Goal of the treatment is a maximal effect with minimal side effects. There are various treatment options, including conventional pharmacological and complementary approaches. Acupuncture is a system with an empirical basis, which has been used in the treatment for centuries. The mechanisms can be partly explained in terms of endogenous pain inhibitory systems. Its use for pain relief has been supported by clinical trials and this has facilitated its use in pain clinics in most countries. Needle acupuncture and other forms of sensory stimulation produce similar physiological changes in humans and mammals, e.g. rhythmic discharges in nerve fibres, and the release of endogenous opioids. Besides acupuncture points located on "meridians" all over the body acupuncture points are also described on the ear. The stimulation of acupuncture points can be achieved by pressure, a mechanical action of needling, or electrical point stimulation. In chronic pain treatment acupuncture has been found to be more effective than other non-pharmacological therapies. Furthermore, continuous electrical stimulation of auricular acupuncture points improves the treatment of chronic cervical pain patients. Finally, acupuncture represents not only a therapeutically beneficial, but also a cost-effective treatment option. Auricular acupuncture is also known to be effective in treatment of acute postoperative pain.

The aim of our study is to investigate in a randomized, prospective, double - blind, and controlled design whether continuous electrical stimulation of auricular acupuncture points results in reduction of postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* female ASA physical status I-III patients undergoing elective gynaecological laparoscopy

  * (surgery in cases of infertility, ovarian cyst removal, adhesiolysis, adnexal surgery,endometriosis, or hysterectomy),
* aged from 18-60 years.

Exclusion Criteria:

* patients with a history of drug abuse,
* regular use of sedatives,
* chronic analgesic medication,
* neurological or psychiatric diseases,
* adverse reaction to sevoflurane or paracetamol,
* ASA physical status \> III,
* pacemaker, or a history of acupuncture treatment.
McGrath Series 5 Videolaryngoscope for Double-lumen Tube Intubation

1. Double-lumen tube intubation is difficult, compared with single lume tube.
2. McGrath Series 5 videolaryngoscope hase been used in difficult airway management, both in anesthetized and awake patients.
3. But there was little information about McGrath Series 5 videolaryngoscope for double-lumen tube intubation.

In this study, the purpose was to evaluate the success rate and intubation time of McGrath Series 5 videolaryngoscope for double-lumen tube intubation in patients without predictors of difficult intubation.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* thoracic surgery
* ASA classification 1-3

Exclusion Criteria:

* Emergent operation
* predicted difficult airway
* difficult ventilation
* limited mouth opening
Diabetes Mellitus With Pregnancy in Benisuef Localities

The aim of this work is to demonstrate the variation of Diabetes mellitus either preexisting or gestational Diabetes mellitus among pregnant ladies in our localities, detect maternal \& fetal complications and to predict the risk factors for poor maternal, fetal \& neonatal outcomes


Eligibility Criteria:
Inclusion Criteria:

* all pregnant ladies with Diabetes mellitus either type 1 or type 2
* all pregnant ladies with glucose intolerance which is first diagnosed during current pregnancy

Exclusion Criteria:

* ladies age less than 18 year or above 45
Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma

The purpose of this study is to determine the feasibility and preliminary effects of a novel treatment approach to improve arm function in patients with scleroderma who have upper extremity contractures. It is a Phase 1, one arm trial in which participants will be assessed at baseline, 4 weeks, and 8 weeks. The rehabilitation intervention will involve 8 individual sessions with an occupational therapist. Feasibility of the procedures is a major focus of this project.

Our specific aims are to:

1. Determine the feasibility of a novel rehabilitation strategy provided at the University of Michigan Scleroderma Clinic to scleroderma patients who have upper extremity contractures.

   Investigators will assess 3 main aspects of the process that are key to the success of a larger study including the proportion of eligible people who enroll in the study, rate of adherence to the treatment protocol, and the time it takes to conduct sessions including treatment and outcome assessment completion. Based on a framework of recommendations for well-designed pilot studies \[1\], investigators have set the following criteria for success to examine these aspects:
   1. At least 50% of participants who are eligible for the study will enroll.
   2. At least 80% of participants will attend all treatment sessions.
   3. The 3 sessions involving both treatment and outcome assessments will not last on average more than 2 hours.
2. Develop a standardized treatment manual to train therapists to provide this treatment to their patients.

   A standardized treatment manual for therapists is a critical component needed to ensure consistency in a larger multi-site trial. This manual will be drafted for use in this study and refined as needed.
3. Establish preliminary effects of this 8-week rehabilitation program on improving arm function.

Investigators hypothesize that participants with scleroderma will have significant improvements in the QuickDASH disability measure at post test. Although the investigators think large effects will be shown, this study will allow us to determine estimates of the effects and the variability for power calculations in a multi-site trial.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of scleroderma (localized or generalized morphea)
* Have a contracture of the hand and other joint in at least one arm, such as wrist, elbow, or shoulder, with the ability to demonstrate active range of motion in that arm
* Willing to travel to participate in therapy and outcome assessments.
* English speaking

Exclusion Criteria:

* active hand ulcers
NIPE Monitoring Values During Routine Pediatric Anesthesia

Description of the standard values and fluctuations of the new NIPE index during routine pediatric anesthesia. NIPE monitor connected to anesthesia monitor, displays an instantaneous value ranging from 0 to 100. NIPE values described at different time points during anesthesia: beginning of induction, intubation, extubation, skin incision, opioid administration, vasopressors or atropine administration, transfusion, volume expansion. In addition, NIPE values during hemodynamic events (heart rate or blood pressure increase greater than 20%) will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Surgery under general anesthesia
* Absence of analgesic treatment in the 24 hours before the intervention

Exclusion Criteria:

* Central or peripheral neuropathy
* Non sinus arrythmia, pace maker
* Cardiac surgery
* Analgesic medication within 24 hours before surgery
* Anti cholinergic or anti arrythmic chronic medication
* Opposition of the legal tutor or of the child
Evaluation of Pain in Urinary Collections in Pediatric Emergencies in Children Who Have Not Acquired Cleanliness

Observational study.

Febrile urinary infections account for 5% of unexplained causes of fever in children up to 2 years of age. Urinary samples are therefore very common in pediatric emergencies. In children who have not acquired cleanliness, the most used method of collection is the placement of a sterile urine bag on the perineum. It allows a noninvasive urinary collection. However from a bacteriological point of view this method is debatable because the rate of contamination of the collections is important. This mode of collection is of interest only to exclude a urinary infection, by the realization of a urinary strip.

Pocket-collected urine is not reliable for bacteriological analysis in culture. For example, if the urine strip is positive, the American Academy of Pediatrics recommends urine sampling by urine sampling (or other invasive methods) for culture.

The urine bag should be changed every 30 minutes to avoid the risk of contamination. The technique is wait-and-see, the installation of several pockets is often necessary before obtaining urine.

A study carried out in 2014 shows that in 39.4% of the cases the withdrawal of the urinary pouch was as much more painful than the urinary sounding, in the same patient. To our knowledge there is no other study dealing with the difference in pain engendered by these two methods.

Since the urinary catheterization is faster, bacteriologically justified and necessary if the pocket collection is positive, it seems legitimate to ask ourselves if we should not aim at a generalization of the urinary catheterization, as first intention, Having not acquired cleanliness, requiring a withdrawal of urine for suspicion of urinary infection.

Many centers continue to use urinary pocket collection mainly, as the survey technique seems too invasive and painful.

Eligibility Criteria:
Inclusion Criteria:

Children under 3 years of age who have not acquired the cleanliness present at the pediatric emergency department in Rennes, where urine sampling is necessary in case of suspected urinary tract infection.
Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.

At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression.

In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological.

The question is to know if this strategy is feasible in lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Non squamous non small cell lung cancer histologically or cytologically confirmed with no EGFR mutation.
* Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is asymptomatic.
* Measurable disease (recist criteria)
* Age ≥18 years
* PS0 or 1

Exclusion Criteria:

* Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated cancer
* History of malignant tumour excepted cervical and basocellular cancer and cancer cured for at least 5 years.
* Tumor invaded the big vessels or the proximal visible in TDM.
* History of adjuvant or neoadjuvant chemotherapy
Cardiac Biomarkers in Patients With Single Ventricle Physiology

All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.

These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.

All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.

These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Hypoplastic Left Heart Syndrome as congenital heart disease as a neonate

Exclusion Criteria:

Other diagnosis of congenital heart disease than Hypoplastic Left Heart Syndrome Patients older than 30 days
Impact of the Relaxation Response Resiliency Program on Patients With Atrial Fibrillation

The purpose of this study is to determine if an eight week multimodal Relaxation Response Resiliency Program (3RP) intervention can effectively improve symptom severity, frequency and quality of life (Q.O.L) in atrial fibrillation (AF) patients. This will be measured by a reduction in AF symptom score, perceived stress, anxiety, hostility and depression.

Atrial fibrillation (AF) is a very common cardiovascular disease. Symptoms include dizziness, palpitations, lightheadedness, shortness of breath, fatigue and exercise intolerance. AF is also associated with a high risk of complications like thrombo-embolism and stroke, heart failure, dementia. The presence and severity of these symptoms and complications adversely affect a patient's health related quality of life. Improvement in quality of life (QOL) is an important measure for evaluating response to treatment in AF patients. Depression and anxiety are significant part of the psychosocial burden faced by approximately one-third of AF patients, and are important components that effect QOL in these patients. In this study the investigators will apply the 3RP (Relaxation Response Resiliency Program - developed at the Benson Henry Institute at Massachusetts General Hospital) intervention among AF patients to assess the reduction in their stress, anxiety and depression levels and the reduction in AF symptom burden and severity.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-90 years
2. Diagnosed with documented recurrent symptomatic paroxysmal atrial fibrillation
3. Currently on stable medical therapy for AF and willing to continue on the same treatment regimen for 8 weeks while participating in the study.
4. No current or prior practice of yoga, meditation, guided imagery or other techniques that elicit relaxation response (RR).
5. Able to provide informed consent and to understand written and spoken English.

Exclusion Criteria:

1. End Stage renal failure or heart failure, severe unstable medical or psychiatric disease
2. Patients deemed unable to complete protocol due to cognitive or other reasons.
3. Patients on psychoactive medications will have eligibility determined by the PI or MD co-investigator on a case-by-case basis, and will be admitted to the study if medication is deemed stable
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects

This phase 1, randomized, double-blind, placebo-controlled study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of CSL730 administered by subcutaneous (SC) injection or SC infusion in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female adult subjects aged ≥ 18 to ≤ 55 years
* Females must be either postmenopausal or sterile
* Body weight between ≥ 50 and ≤ 110 kg and body mass index between ≥ 18.0 kg/m2 and ≤ 30 kg/m2

Exclusion Criteria:

* History or current evidence of a clinically significant medical condition, disorder, or disease, including but not limited to any of the following: hepatic (hepatitis, cirrhosis, or history of liver disease, drug reaction, or aminotransaminase elevations, if known); biliary; renal; cardiac; bronchopulmonary; vascular; hematologic; gastrointestinal; allergy; endocrine / metabolic (diabetes, thyroid disorders, adrenal disease); neurologic (including history of migraine); psychiatric; immunologic; dermatologic; oncologic (subjects with resected cervical or skin cancer \[except melanoma\] who have had no evidence of disease in the last 5 years are eligible), that precludes designation of healthy subjects as judged by the Investigator
* History or evidence of congenital or acquired immunosuppressive condition(s), including positive serology for human immunodeficiency virus infection or taking immunosuppressive agents.
* Evidence of active or latent tuberculosis
* Hospitalization within 3 months before IP administration or planned hospitalization at any time during the study.
* History of any drug allergy, hypersensitivity (excluding hay fever) or intolerance to latex or any drug product
* A positive test result for drugs of abuse.
* Smokers within 3 months before Screening.
Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair

Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal pelvic organ prolapse repair in women with anterior POP with or without apical vaginal involvement

Calistar S Single Incision Pelvic Organ Prolapse (POP) Repair System is intended for transvaginal reestablishment and reinforcement of the physiologic anatomy of the female pelvic floor in non-fertile women with anterior pelvic organ prolapse with or without apical vaginal wall involvement in both, recurrent pelvic organ prolapse and primary pelvic organ prolapse when other surgical procedures are expected to fail (i.e. complex primary prolapse).

The treatment kit consists of the lightweight mesh, two single-use introducers and 3 tissue anchoring system (TAS) anchors for fixation to the sacrospinous ligament. The product is approved in accordance with the CE Directive 93/42/EEC.

The utilization of synthetic implants in POP repair became increasingly popular in the last decade. The cumulative success rate of synthetic implants in anterior compartment repair is as high as up to 93%.However, meshes have been recently scrutinized due to high adverse event reporting after unreflected utilization of meshes which raised concerns of patients safety; furthermore taking into account the complexity of adverse event mesh management. This led to a vanishing of various meshes in transvaginal POP repair. Nevertheless, the further development of light weight meshes, the experience of the surgeon and the assessment and patients selection are well known factors reducing the rate of adverse events significantly.

Therefore, in the current trial the efficacy and safety of calistar S in a highly selected patient population will be evaluated.

Eligibility Criteria:
Inclusion criteria Non-fertile women \> 18 years1 2. Symtomatic anterior prolapse with or without apical vaginal wall involvement according POP-Q score ≥ 2. (Corresponding to Aa, Ba ≥ -1 and where applicable C ≥ -1/2 TVL ).

3. Subjects with recurrent prolapse or complex primary prolapse are eligible for the study.

4. Scheduled mesh-augmented anterior POP repair with Calistar S 5. Signed inform consent

Exclusion criteria

1. Fertile women
2. Patients with active or latent infection of the vagina, cervix or uterus
3. Patients with previous or current vaginal, cervical or uterine cancer
4. Previous, current or planned pelvic radiation therapy
5. Known allergy to polypropylene

7. Subject is unable or unwilling to complete questionnaires (either self-administered, assisted or interviewed) and/or to follow scheduled visits and/or to sign informed consent
Study of the Incidence of Surgical Site Infections Developed by Patients Hospitalized in the Wards of a Large Teaching Hospital in Rome, Italy

The surgical departments of the hospital were included in the study on a rotational basis over a period of 5 months. All patients undergoing surgery during this period were enrolled in the study.

The data collection in each department lasted 6 months (8 in the case of the use of prostheses) of which:

* 5 months of continuous survey of hospitalized patients
* 30 days of post-operative surveillance for all operations, 90 days for operations involving the use of prosthetic material Surveillance ends when a surgical site infection occurs, even if the event is prior to 30 or 90 days.

For each surgery, information was recorded such as the type of surgery, duration, ASA score, prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* patient undergoing surgery

Exclusion Criteria:

-