cyrilzakka/clinical-trials huggingface dataset:
Whole Body Vibration - a New Therapeutic Approach to Improve Muscle Function in CF

The purpose of this study is to evaluate the effects of whole body vibration (WBV) on muscle function in adult CF-patients.

Cystic Fibrosis (CF) is the most common chronic hereditary disease in Caucasians. Due to improved therapy and better understanding of the disease, life expectancy has risen to an average of 38 years and is continuing to rise. With the increased life-expectancy it becomes even more important to maintain functional activity as part of quality of life. Mechanical stimulation in form of whole body vibration (WBV) is a new type of exercise currently tested in sports, geriatrics and rehabilitation. It has recently been found to be a safe and efficient method to activate muscular activity via stretch reflexes leading to improvement of muscular performance, body balance and physical functioning.

10 patients of the CF Center Cologne, Germany, took part in the Galileo study. They were provided by the vibrating platform (Galileo 2000)for whole body vibration training at home. The patients were standing in an upright position receiving vertical vibration of frequencies between 20-25 Hz. This vibration exercise evokes muscle contractions via stretch reflexes improving muscular activity. The training schedule consisted of three 3-minute sessions twice a day 5 days per week for 3 months.

Every 4 weeks the patients were seen for assessment of muscle function to evaluate the effects of this new intervention.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Cystic Fibrosis
* age older than 18 years

Exclusion Criteria:

* hypersplenic syndrome
* acute arthritis or osteomyelitis
Preoperative Information With Storybook for Pediatric Anesthesia

Impacts of non-pharmacologic methods that help patients get prepared cognitively for processes of surgery and anesthesia on pediatric surgery patients' preoperational stress levels and anxiety levels had been examined in the scope of this comprehensive research project. In this project, a goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric surgery patient including inguinal hernia repair, circumcision and tonsillectomy.
* without having previous emergency surgery and anesthetic experience,

Exclusion Criteria:

* Their parents reported developmental delays, mental retardation, or chronic illnesses of the children
* Emergency surgery
A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)

This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement therapy (ERT) for mucopolysaccharidosis type II (MPS II).

Participants may also qualify to enter an open-label treatment phase with DNL310 or idursulfase based on pre-specified criteria.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants aged ≥2 to \<6 years (Cohort A) or ≥6 to \<26 years (Cohort B)
* Confirmed diagnosis of MPS II (for Cohort A, nMPS II; for Cohort B, nnMPS II)
* Have no history of treatment with enzyme replacement therapy (ERT) OR not have received continuous ERT for 4 months prior to screening OR be on maintenance ERT and have tolerated idursulfase for a minimum of 4 months prior to screening

Key Exclusion Criteria:

* Have a documented mutation of other genes or genetic diagnosis accounting for developmental delay
* Previously received an iduronate 2-sulfatase (IDS) gene therapy or stem cell therapy
* Received any CNS-targeted MPS ERT within 6 months prior to screening
* Have a contraindication for lumbar punctures and/or magnetic resonance imaging (MRI)
* Participated in any other investigational drug study or used an investigational drug within 60 days prior to screening or intend to receive another investigational drug during the study
Chart Review Study of Medical Abortion

The primary objective of this study is to document the rates of success and serious complications among women having outpatient medical abortions with 200 mg mifepristone + 800 buccal misoprostol at 64-70 days of gestation.

The study will be conducted at US abortion clinics that have offered medical abortion with 200 mg mifepristone + 800 mcg buccal misoprostol to at least 20 women at 64-70 days of gestation. Designated staff at each site will review clinic records to identify and record data from every patient treated in that gestational week. Once data collection is completed, if the rate of success or serious complications at any clinic is substantially discordant from rates documented in the published literature, we may collect additional data on patients seeking medical abortion at 57-63 days, to aid in explaining results found in the 64-70 days group. In this situation, for each patient in the 64-70 days group, site staff will identify and record data from the next consecutive patient treated with this regimen at 57-63 days.

Eligibility Criteria:
Inclusion Criteria:

* Women at 64-70 days of gestation
* Received 200 mg mifepristone + 800 mcg buccal misoprostol for a medical abortion

Exclusion Criteria:

* Does not meet the inclusion criteria
Evaluation of the Surgical Pleth Index During Spinal and General Anesthesia

The Surgical Pleth index (SPI) has been introduced as a non invasive tool to "measure" stress and pain during surgery. Preliminary studies were performed in patients under general anaesthesia with propofol and remifentanil. These trials showed a good correlation between SPI and aching procedures and a negative correlation between SPI and the remifentanil dosage. Hence, it was concluded that SPI may be a bedside tool to measure 'pain' during surgery. So far, no study investigated SPI during regional anaesthesia.

1. Spinal anaesthesia secures full pain relieve and muscle relaxation usually in the lower part of the body. Thus, SPI - a measure that reflects pain during surgery - may not exceed significantly compared to baseline. It may slightly increase only during administration of the block.
2. Increasing SPI values due to surgery under subarachnoid block may reflect intraoperative patient's stress mediated by activation of the autonomic nervous system, specifically sympathetic activation.
3. In consistence with previously published data no changes of SPI should occur due to standardized sedation with propofol.

Eligibility Criteria:
Inclusion Criteria:

* surgical procedures feasible under general or spinal anesthesia
* duration between 30 and 90 min
* ASA status I,II or III

Exclusion Criteria:

* contraindications against one of the anesthesia methods
* age under 18
* emergencies
* chronical pain history
* lack of sinus rhythm
Whole Body Vibration and Unstable Shoes on Balance in Healthy Young People

Aim: To compare the effect of different type of shoes (unstable or stable) combined with a whole body vibration training on balance.

Design: Randomized controlled trial.

Setting: Laboratory of biomechanics.

Population: Healthy young people.

Background: The use of whole body vibration to train strength and balance has increased in the last years. Last studies have shown that adding an unstable device increased electromyographic activity of the lower limb and the trunk muscles. However, no studies have investigated the effects of wearing unstable shoes during a whole-body vibration training on balance in healthy young people.

Aim: To compare the effects of different type of shoes (unstable \[Intervention group\] or stable \[Control group\]) combined with a 12-weeks whole body vibration training on balance.

Setting: Laboratory of biomechanics.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \< 35.

Exclusion Criteria:

* Cardiovascular disease, incapacity to practice a physical activity, musculoskeletal pathologies, neurologic diseases, previous experience with unstable shoes, previous experience with whole-body vibration.
Robot-assisted Laparoscopic Partial Nephrectomy Via the Extraperitoneal Approach in the Prone Position Versus the Lateral Position

The goal of this clinical trial is to investigate whether robot-assisted laparoscopic partial nephrectomy by extraperitoneal approach in the prone position had any advantages over the traditional lateral position. The main questions it aims to answer are:

Is prone surgery safe and feasible, and what are the advantages over the traditional lateral position? Does surgery in the prone position have an impact on the patients\&#39; prognosis? Researchers will compare prone position to lateral position to see if robot-assisted laparoscopic partial nephrectomy by extraperitoneal approach in the prone position has any advantages over the traditional lateral position and whether it has any significant effect on the prognosis of the patients.

Participants will be randomly allocated 1:1 to two groups: prone position group and lateral position group. The enrolled patients will be underwent robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach according to the corresponding positions of their groups. Demographic indicators and perioperative-related indicators will be counted and recorded. CT or MRI and related biochemical examinations will be reviewed at 1 month, 3 months, 6 months and 1 year after surgery, and every 1 year thereafter. The similarities and differences of the indicators in different positions will be analysed, and subgroup analyses will be performed according to the corresponding results.


Eligibility Criteria:
Inclusion Criteria:

1. . Patients with preoperative imaging suggestive of renal occupancy;
2. . Sex is not limited;
3. . Age ≥18 years;
4. . Clinical staging consistent with indications for partial nephrectomy;
5. . Suitable for robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach as judged by relevant preoperative clinical data;
6. . Agree to provide basic clinical information and pathological and imaging data for scientific research and sign an informed consent form;
7. . Agree to provide monitoring results during the follow-up recurrence monitoring process.

Exclusion Criteria:

1. . Patients who did not meet the indications for partial nephrectomy and did not undergo robotic-assisted laparoscopic partial nephrectomy via extraperitoneal approach;
2. . Patients who refuse to undergo or cannot tolerate surgery in the appropriate position;
3. . Patients with incomplete documentation of relevant data to provide accurate demographic, perioperative, and prognostic data;
4. . Any condition which, in the opinion of the investigator, may be detrimental to the subject or result in the inability of the subject to meet or perform the requirements of the study;
5. . Patients who are unable to provide written informed consent;
Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

This study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, within age limits as defined by local regulations and local product label, who have previously been treated with, who are currently being treated with or initiating treatment with ranibizumab for any approved indication included in the local product label
* Willing and able to provide informed written consent personally or by legal proxy

Exclusion Criteria:

* Simultaneous participation in a study that includes administration of any investigational drug or procedure
* Systemic or ocular treatment with any VEGF inhibitor other than ranibizumab in the 90 days prior to enrollment
* Other protocol-defined inclusion/exclusion criteria may apply
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants

Hypothesis to be Tested:

Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to tolerate enteral feeds such as Short Bowel Syndrome, Chronic Intestinal Pseudoobstruction, Microvillus Inclusion Disease, Crohn's disease, multi-organ failure and prematurity. Parenteral Nutrition-Associated Liver Disease (PNALD) encompasses a spectrum of disease including cholestasis, hepatitis, steatosis and gallbladder sludge/stones which may progress to liver cirrhosis and even failure.

There is a direct correlation between duration of parenteral nutrition and development of cholestasis in infants. There is evidence in animals and humans that cycling of parental nutrition, defined as infusing nutrients over a time period shorter than 24 hours, reduces cholestasis. There is also data that premature infants with gestational age (GA) \< 32 weeks and birth weight \<1500g, as well as infants with congenital anomalies of the gastrointestinal tract, are among those at highest risk of developing Parenteral Nutrition-Associated Cholestasis (PNAC).

We therefore hypothesize that infants with gestational age (GA) \<32 weeks and birth weight (BW) between \<1500g, or with congenital anomaly of the gastrointestinal tract regardless of GA or BW, receiving PN over a period of 20 hours will have a decrease severity of PNAC, demonstrated by a lower peak direct bilirubin, compared to a similar control population receiving standard 24 hour infusion.


Eligibility Criteria:
Inclusion Criteria:

1. Infants expected to need prolonged PN (receiving \>75% PN on dol 7) with the following risk factors:

   1. Prematurity with gestational age (GA) \<32 weeks AND birth weight \<1500g. OR
   2. Congenital anomaly of the gastrointestinal tract regardless of GA or BW
2. Screening direct bilirubin prior to the initiation of parenteral nutrition \<2mg/dL.

Exclusion Criteria:

1. Infants with major congenital anomalies, other than those of the gastrointestinal tract.
2. Infants with known obstruction of the hepatobiliary tract.
3. Infants with suspected congenital infection or suspected genetic/metabolic syndrome predisposing them to cholestasis based on direct bilirubin \> 2mg/dL prior to instituting PN.
Acetaminophen Randomized Controlled Trial

Patients that are to undergo isolated meniscectomy will be randomized to 2 cohorts: one will take the FDA recommended dose of acetominophen (1000mg) 24hrs before surgery, one will be given a similarly looking placebo pill. A multitude of post-op variables will be included, mainly pain scores and morphine equivalent doses at different time points.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* ASA Class I-II
* Patients scheduled for meniscectomy

Exclusion Criteria:

* Contraindication to acetaminophen (hypersensitivity, extensive alcohol history, liver disease, actively breastfeeding)
* Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age or older than 65
* Any patient considered a vulnerable subject
* Patients on pain medication prior to surgery
Comparison of Two Ventilation Modes With Laryngeal Mask Airway Guardian

The purpose of this study is to compare volume- and pressure- controlled ventilation with laryngeal mask airway Guardian in obese patients undergoing laparoscopic gynecologic surgery in terms of ventilatory efficacy, airway leak pressure (airway protection), ease-of-use and complications.

The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. The aim of the following perspective, randomized, blind trial study id to compare how the volume-controlled ventilation and pressure-controlled ventilation modes using the Laryngeal Mask Guardian affect the pulmonary mechanics, the gas exchange and the cardiovascular responses particularly in obese patients undergoing gynecological laparoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients scheduled to undergo laparoscopic gynecologic surgery under a short general paralysed anesthesia of less than 2 hours (ASA physical status I-II)
* 18 to 65 years of age
* A body mass index \<40 kg • m-2

Exclusion Criteria:

* Difficult airway
* Recent history of upper respiratory tract infection and sore throats
* A history of esophageal reflux disease
* Kinesia patients
* Inability to understand the Study Information Sheet and provide a written consent to take part in the study
Impact of Supra-renal Fixation of EVAR on Hemodynamics of Renal Arteries

The investigators conducted a bicentric prospective study to quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation EVAR with suprarenal fixation immediately postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* elective EVAR with supra renal fixation
* women who have been postmenopausal for at least 24 months or are surgically sterilized, or for women of childbearing potential, use of an effective method of contraception
* consent to participate
* Affiliation to a French social security

Exclusion Criteria:

* stenosis of at least one renal artery
* dialysis
* rupture of abdominal aortic aneurysm
* renal stenting during the procedure
* fenestrated EVAR
* legal incapacity or limited legal capacity
* subject being in the exclusion period of another study
* pregnant woman
The EUS ShearWave Elastography Liver Fibrosis Study

The study objective is to demonstrate the clinical performance of ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS) when compared to FibroScan for evaluation of liver fibrosis.

This study has been designed as prospective, single center, single arm, consecutive, blinded, pilot study conducted in a post-market setting using commercially available devices to evaluate the effectiveness of Endoscopic Ultrasound with ShearWave Elastography to estimate hepatic fibrosis in patients with chronic liver disease. It is anticipated that the data from this study will support the need for additional clinical trials. All consenting, eligible patients reporting for an ultrasound and/or liver biopsy for evaluation of fibrosis meeting the inclusion criteria will be consecutively enrolled into the study and assigned a unique study identification number. A total of 52 subjects will be enrolled and treated at a single study site in the US. Enrollment is expected to be completed within 6 months. Each subject will undergo both procedures (FibroScan and EUS with SW Elastography), End of study will be reached after pathology results have been obtained (within a week of the initial procedure).

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Willing and able to provide informed consent
3. Undergoing diagnostic EUS procedure with liver biopsy
4. Baseline CBC, CMP, INR within 3 months

Exclusion Criteria:

1. Contraindication to EUS-guided liver biopsy
2. Baseline platelet count \<50,000
3. Baseline INR \>1.5
4. Patient is a prisoner
Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid

Melasma is an acquired discoloration of the skin characterized by brown patches. Chemical peels using agents such as Jessner's solution and trichloroacetic acid (TCA) are commonly used to treat melasma. A chemical peel involves applying the peeling agent to the skin for a short period. The skin will peel similar to a sunburn, and moisturizers are applied to the skin. Although both agents are well-accepted, there have been no good comparisons of the two agents. The purpose of this study is determine if there is a difference in the effectiveness of these two agents.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years old
* Clinical diagnosis of melasma
* Mental capacity to give informed consent

Exclusion Criteria:

* Pregnancy
* H/o allergy to Jessner's solution, tricholoracetetic acid, tretinoin, or hydroquinone
* Active dermatitis
* Presence of cutaneous infection
Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

The participants included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan.The objective of this study is to estimate the rate of serious infections, tuberculosis, malignancies, and other outcomes in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients treated with golimumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic non-biological treatments.

The participants included in this study will be drawn from the Ingenix Normative Health Informatics Database, a proprietary research database containing claims and enrollment data dating back to 1993 for members of a large, geographically diverse US health plan. This study will include cohorts of participants who have claims consistent with a diagnosis of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis and who initiate golimumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological treatments. Participants will be identified by claims bearing codes for dispensed drugs, procedures or diagnoses and followed after the launch of golimumab for up to 8 years. A sample of enrolled health plan members without claims evidence of diagnosis or treatment of Rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis will also be selected. The claims database will be used to estimate the incidence of the primary outcomes of serious infections, tuberculosis (TB) and non-TB mycobacterial infections, malignancies such as lymphoma, and other selected outcomes. No study agents will be administered in this study. All participants will receive standard-of-care treatment as prescribed by their physician

Eligibility Criteria:
Inclusion Criteria:

* Complete medical coverage and pharmacy benefits
* Six months of continuous enrollment prior to the date of cohort entry

Exclusion Criteria:

* Participants will be excluded if they do not have information on age, gender or enrollment