cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor

This study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects as defined in the protocol
* Subjects who weigh \>50 kg at Screening

Exclusion Criteria:

* History of any illness or condition that might confound the results of the study or pose an additional risk to the subject upon administration of study drug - Positive for hepatitis B,C, or HIV
* Standard 12-lead ECG demonstrating QTc \>450 msec for male subjects and \>480 msec for female subjects at the Screening Visit
* Abnormal renal function as defined in the protocol at Screening
* Forced expiratory volume in 1 second (FEV1) \<80% predicted at the Screening Visit
* Blood donation (of approximately 1 pint \[500 mL\] or more) within 56 days before the first dose of study drug
* Treatment with an investigational drug or device within 30 days or 5 half-lives preceding the first dose of study drug
Clinical Usefulness of Cortisol, Antinuclear Antibodies and High-sensitivity C-reactive Protein in Acute Pancreatitis

Acute pancreatitis (AP) is a potentially life-threatening disease with varying severity of presentation. Nearly 60%-80% of all cases of AP in developed countries are attributable to either gallstone disease or alcohol abuse. The incidence is similar in both sexes, although alcohol abuse is the more common cause in men and gallstones is the more common cause in women.

Severe acute pancreatitis is one of the most common acute abdomens in clinical practice. Owing to its acute onset, rapid progress, and high mortality, it has become a hot clinical study spot and one of the toughest medical problems. Markers of inflammation, such as high-sensitivity CRP (hs-CRP), are predictive of the severity of acute pancreatitis and may be useful in identifying patients with severe acute pancreatitis in the early phase after onset.

Antinuclear antibodies (ANA) are important biomarkers for the autoimmune disorder. ANA may contribute to the pathogenesis of pancreatitis and ANA positivity is associated with the presence of autoimmune pancreatitis. Cortisol is released into the blood due to stimulation of corticotrophin receptors in the adrenal cortex. Thus, serum cortisol can be measured. Although the association between serum levels of some inflammatory marker and acute pancreatitis revealed, the relationship between ANA, cortisol, hs-CRP and with the severity of acute pancreatic lesions have not evaluated yet.

Eligibility Criteria:
Inclusion Criteria:

* abdominal pain consistent with AP
* serum amylase activity at least 3 times greater than the upper limit of normal
* Patients of age 18 years or more who are willing to participate in the study and give their consent for same.

Exclusion Criteria:

* Patients with severe liver disease, pulmonary embolus, sepsis, and renal failure were excluded from the study.
Motor Performance in Children With Attention Deficit Hyperactivity Disorder

Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in children. Children with ADHD have difficulties with co-contraction, producing muscle force, and regulating movement velocity, and physical fitness. The purpose of this study was to compare the gross and fine motor abilities in children with ADHD and children with typical development.

Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in children worldwide with a prevalence of 2.6-4.5% between the ages of 6 and 18 years. When compared to children with typical development, children with ADHD have lower scores in 9-12% of gross motor abilities, 9-36% of balance and postural control, 9-19% of fine motor abilities, and 19-22 % of manual and body coordination. Furthermore, children with ADHD have difficulties with co-contraction, producing muscle force, and regulating movement velocity, and physical fitness. As a consequence of the core symptoms of ADHD, such as inattention, impulsivity, and hyperactivity, over 30-50% of children with ADHD may have impaired motor ability. The purpose of this study was to compare the gross and fine motor abilities in children with ADHD and children with typical development.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of children with attention deficit hyperactivity disorder
* aged at 6 -15 years old
* able to understand and accept verbal instructions.

Exclusion Criteria:

* Clinical diagnosis of children with another psychiatric including autism spectrum disorder, psychotic symptoms, depression
* Clinical diagnosis of children with neurological disorder including cerebral palsy, epilepsy, or speech impairments
* the parents declined to participate in the study.
Investigation of Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness

The objective of the clinical investigation is to evaluate the efficacy and tolerability of WO 2707, a MoistCream Cremolum, with respect to the application in postmenopausal women with symptoms of vaginal dryness.


Eligibility Criteria:
Inclusion Criteria:

1. Post-menopausal women with the subjective symptomatology of vulvovaginal atrophy with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a score of at least "2" (moderate) for the parameter dryness at screening and visit 1 (day 1)

   * Thereof at least for 48 included patients: sexual activity with dyspareunia
   * Thereof at least 32 included sexually active patients with at least moderate (score of "2") dyspareunia
2. Natural cessation of last menstruation more than 12 months before screening OR bilateral oophorectomy with or without hysterectomy more than 3 months before screening
3. Signed written informed consent before participation in the clinical investigation

Exclusion Criteria:

1. Vaginal inflammation which is not caused by vulvovaginal atrophy
2. Non-healed vaginal surgery
3. Systemic hormonal replacement therapy (tablets, patches, injections, dermal products), or phytohormonal therapy or use of SERMs (selective estrogen receptor modulators) within 3 months before visit 1 (day 1) and / or during the conduct of this clinical investigation
4. Local hormonal therapy (vagina/vulva) within 3 months before Screening (also when used for the brightening/pretreatment of cytological smears)
5. Any use of products (including lubricants), other than the investigational medicinal device, applied intravaginally or on the vulva during the clinical investigation (except usual cleansing products)
6. Systemic corticosteroids within 21 days before visit 1 (day 1) and during the conduct of this clinical investigation (corticoid asthma sprays are allowed)
7. Use of antibiotics, antiseptics or antimycotics with expected or suspected systemic or vaginal/vulvar bioavailability within 21 days before visit 1 (day 1) and / or during this clinical investigation
8. Known hypersensitivity against any of the ingredients of the investigational medical device
9. Employees of the investigation sites who are directly involved in this clinical investigation or employees of the sponsor's company
Phase 3 Efficacy and Safety Study of GTX-102 in Pediatric Subjects With AS

The primary objective of this study is to evaluate the effect of GTX-102 in cognitive function in participants with deletion-type Angelman Syndrome (AS).


Eligibility Criteria:
Key Inclusion Criteria:

* Signed informed consent from parent(s) or legal guardian(s)
* Confirmed diagnosis of AS with genetic confirmation of full maternal ubiquitin-protein ligase E3A (UBE3A) gene deletion causing AS in the region of 15q11.2 q13
* Able to ambulate independently, or with assistance at the Screening Visit (note, a child whose primary means of mobility is by wheelchair is excluded from the study)
* Platelet count, prothrombin time / international normalized ratio, and partial thromboplastin time within 1.5x the normal limits at the Screening Visit
* Willing and able to comply with scheduled visits, drug administration plan, laboratory tests, and all study procedures, including LP procedure, MRI, and tolerating anesthesia without intubation
* From the time of informed consent through to at least 6 months after the final dose of GTX-102, females of childbearing potential who are sexually active must use highly effective contraception or abstinence. Males are able to participate if they agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the study and for at least 3 months after the final dose of GTX-102

Key Exclusion Criteria:

* Any change in medications or diet/supplements intended to treat symptoms of AS (eg, sleeping aids, antiseizure medications, supplements, dietary change including ketogenic or low-glycemic index diet, other) within the month prior to the Screening Visit (excluding weight-based adjustments)
* Any condition that creates an increased risk of unsuccessful LP
* Current or expected concomitant use of drugs that increase the risk of bleeding (eg, heparin, low molecular weight heparin, platelet inhibitors)
* Known hypersensitivity to GTX-102 or its excipients that, in the judgment of the Investigator, places the subject at increased risk for adverse effects
* Presence or history of any condition, lab abnormality, or infection, that, in the judgement of the Investigator, would interfere with participation, pose undue safety risk, or would confound interpretation of results
* Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study
* Use of any investigational product or investigational medical device within 6 months or 5 half-lives prior to the Screening Visit or any prior use of gene therapy or ASO regardless of duration since last administration
* Concurrent participation in any interventional study
Effect of LY333531 on Vascular and Neural Functions

To determine if protein kinase C beta plays a significant role in vascular endothelial dysfunction, small fiber neural dysfunction, and oxidative stress associated with diabetes mellitus.

32mg Ruboxistaurin; 4 week cross-over treatment.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosed for at least 1 mo and less than 10 yrs prior to visit 1
* HbA1c less than 9% and fasting plasma glucose less than 260mg/dl
* Blood pressure less than 160/100 mmHg
* Total cholesterol less than 300 mg/dl and/or triglycerides less than 600 mg/dl

Exclusion Criteria:

* Subjects treated with a thiazolidinedione (TZD) in 12 weeks prior to visit 1.
* History of heart disease (MI, unstable angina, CVA, TIA, CABG, or percutaneous transluminal coronary angioplasty) w/in 6 months of visit 1 or subjects with BYHA class III or IV congestive heart failure.
* Female subjects of child-bearing potential that are pregnant or intend to become pregnant (i.e. not practicing an acceptable method of birth control)
* TSH greater than 1.5 times upper limit of normal at V1 or other endocrine disease.
* ALT greater than 1.5 times upper limit of normal at V1; Serum creatinine greater than 2.0mg/dl at V1; micro-albumin greater than 300.
Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension

Sacrospinous ligament suspension (SSLS) was first described in 1958. It is commonly performed for correction of apical prolapse. A combination of delayed absorbable and/or permanent sutures are commonly used for the procedure. When permanent sutures are used, risk of suture-related complications is present and patients may require suture removal. In available literature, there is limited data comparing the efficacy and suture-related complications when using different types of sutures. A previous randomized controlled trial demonstrated that using an absorbable suture is equally efficacious as delayed absorbable sutures in SSLS. However, there is no comparison to absorbable versus permanent suture. Our aim is to compare the absorbable suture versus permanent suture for treating pelvic organ prolapse and to compare suture-related complications.

Our primary outcome is comparing POPQ point C at 12 month follow up for absorbable vs permanent suture.

Participants will be randomized 1:1 to absorbable or permanent suture. Follow up will occur at 2-4 weeks, 12 weeks and 12 months after the surgery.

Patient demographics, previous medical and surgical history, baseline physical exam including POP-Q will be collected from the electronic medical record following enrollment. This information will be stored in REDCap which is a secure database system.

Patients will be randomized by in REDCap system with the sequence of 1:1 with blocks of 6.

Patients and assessors will be blinded to the type of suture that was used. The surgeons will not be blinded.

All procedures will be performed by a fellowship-trained, Female Pelvic Medicine and Reconstructive Surgery board-certified surgeon.

Sacrospinous ligament suspension (SSLS) procedure with the assigned suture and any scheduled concomitant prolapse and anti-incontinence procedures will be performed.

Follow up exams will occur at 2-4 weeks, 12 weeks and 12 months post-operatively. The follow up visits will include a POP-Q exam at 12 weeks and 12 months. The 12 months follow up visit will include a PGI-I questionnaire. All participants will also be assessed for any suture-related complications. 12 month POP-Q exam will be completed by one of the providers who will be blinded to the suture type.

There will be no additional follow up visits for participation in the study. The follow up appointments at 2-4 weeks, 12 weeks and 12 months are the times of usually scheduled post-operative follow up.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Females
* Patients of Atlantic Urogynecology Associates undergoing sacrospinous ligament suspension procedure at Morristown and Overlook Medical Centers

Exclusion Criteria:

* Patients who did not undergo sacrospinous ligament suspension procedure based on surgeon's intraoperative decision
* Patients with current gynecologic malignancies
* Patients with history of pelvic radiation
* Patients with history of prolapse repair surgery
Prevalence of Intracranial Aneurysm in Hong Kong Chinese

Intracranial aneurysm (localized dilatation in weakened blood vessel wall) rupture is a catastrophic disease, with half of the victims died and many of the survivors disabled. There is currently no data in the literature for the Chinese population concerning the prevalence, characteristics (location and size) and risk of harboring an unruptured intracranial aneurysm. In this study, the investigators aim to study the population prevalence and characteristics (location and size) of intracranial aneurysm in Hong Kong Chinese, and its cost-effectiveness. The screening is carried out using magnetic resonance angiography (MRA), with a 3-T magnetic resonance system, which is a well-established non-invasive method for intracranial aneurysm detection.

As charted below.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged between 21 and 65 years

Exclusion Criteria:

* Contraindications to MRI
* History of known intracranial pathologies
Clinical Retrospective Study Analysis of Postoperative Complications Following Hepatectomy

Hepatectomy is a crucial surgical method for treating liver diseases such as liver cancer, hepatic hemangiomas, and biliary stones. Although hepatectomy has achieved significant therapeutic effects, postoperative complications remain an inevitable issue. Complications following hepatectomy include liver failure, hepatic vascular thrombosis, wound infection at the hepatic incision, and bile leakage, among others. These complications pose a serious threat to patients' health and life, and also increase the waste of medical resources and the cost of treatment. Currently, research on postoperative complications of hepatectomy mainly focuses on small sample studies from a single center, and most studies only focus on a specific complication, lacking comprehensive and systematic analysis. Therefore, it is necessary to conduct a retrospective study analysis of complications related to hepatectomy to more comprehensively and objectively understand the incidence, risk factors, prevention, and treatment of postoperative complications, providing clinical doctors with more scientific treatment plans and guidance.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients aged 18-80 years 2.Patients who underwent liver resection surgery at the participating centers

Exclusion Criteria:

* Exclusion criteria are as follows:

  1. Prior cancer treatments such as transarterial chemoembolization, ablation, or targeted therapy.
  2. Repeat liver resection surgeries.
  3. Presence of other malignancies.
  4. Concurrent end-stage diseases including active infections, respiratory failure, decompensated heart failure, and autoimmune disease exacerbations.
  5. Inadequate clinical data availability in medical records.
Effectiveness of Child Centered Counseling on Child Nutrition Status

Hypothesis N°1: The "children growth promotion based on approach centered on their specific needs" enhances caretakers and health workers skills, knowledge and practices on breastfeeding, complementary feeding and child care.

Hypothesis N°1: children growth promotion based on approach centered on their specific needs" approach improves children growth and health.


Eligibility Criteria:
-Inclusion Criteria: all women of childbearing age in the third trimester of pregnancy, living in the study area for at least one year at the time of the inclusion and who gave informed consent.

Exclusion Criteria:
Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study

There is no accurate diagnosis method for bruxism for now. Consequences of bruxism over teeth, muscles and articulation of the jaw are important.

This study aims to develop a innovative tool in order to accurately rapidly diagnose bruxism in ambulatory evaluation.


Eligibility Criteria:
Inclusion Criteria:

* adult from 18-70
* patients diagnosed with bruxism according to the following criteria:
* positive question at one of the following question:

  * are you aware of your grinding?
  * does your partner hear you grinding?
  * are you aware that you are frequently tighten your jaws during the day and/or the night?
  * are you tired and/or do experience jaws 'muscular pain in the morning.
* presence of at least one criteria:

  * abnormal tooth wear or tooth prosthesis damages
  * Hypertrophy of the masseter muscles
* patients agreeing to participate
* patient able to understand and follow the protocol
* patient with health insurance

Exclusion Criteria:

* patients with more than 2 missing tooth
* Severe troubles to correctly close the mouth.
* neurological disorder (Parkinson, Alzheimer) or psychiatric disorder
* Sleep disorder (insomnia, narcolepsy, sleep apnea, restless leg disorder)
* use of drugs that potentially impair sleep (benzodiazepines, neuroleptics, tricyclic antidepressants) alcohol or narcotics.
* complete or partial removal dental prosthesis or orthodontic device
* Patient under legal protection
* pregnant women
* Patients deprived of their freedom by a judicial or administrative decision
Toileting at Night in Older Adults: Light to Maximize Balance, Minimize Insomnia

To examine the change in balance that occurs in older individuals when exposed to different colored lights at night.


Eligibility Criteria:
Inclusion Criteria:

* Aged 55-85
* Stable health
* Normal color vision

Exclusion Criteria:

* Alcohol abuse
* Depression
* Sleep disorders
* Smoking
* Use of illegal drugs
Tolerance and Effect on Intraocular Pressure After Administration of SYL040012

The purpose of this study is to determine whether SYL040012 is safe for the treatment of ocular hypertension and glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, any gender
* 18 to 45 years of age,
* Subjects must provide signed informed consent prior to participation in any study-related procedures
* Body Mass Index between 19,5 and 29 kg/m2
* IOP \</= 21 mmHg in both eyes
* Have a BCVA (Best corrected visual acuity) of \>/= 0.8 (20/25) (Snellen scale), or \</= 0.1 (LogMar units)in both eyes
* Normal Fluorescein Clearance Test in both eyes
* Normal funduscopy in both eyes

Exclusion Criteria:

* Pregnant or breastfeeding females or those with a positive pregnancy test. Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the hole study.
* Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplastic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes
* Previous chronic processes or with rebound characteristics that could interfere with study according to the investigator's judgment.
* Volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study.
* Having used anti-cholinergics, betablockers and corticoids sporadically in the last 30 days whichever the route of administration, or any med by ocular or nasal administration route.
* Case history of hypersensitivity to meds or any other allergic process
* Visual alterations: Previous eye surgery, glaucoma, uveitis or ocular surface pathology (dry eye, blepharitis).
* Volunteers with visual alteration with more than 3 dioptres in either eye
* Use of contact lenses
* Volunteer who has participated in a clinical trial during the past four months before study entry.
* Blood or derivate transfusion during the six previous months to study entry
* Case history of drug or alcohol abuse or dependence.
* Positive result in test drug abuse during selection period
* Positive serology results to hepatitis B virus (HbsAg), virus C or HIV
* Analytic alterations medically relevant, at investigator's judgement.
Jena Sepsis Registry

Despite the burden of severe sepsis and septic shock deficiencies in the quality of sepsis management are recognized. Investigators present a population-based registry with easy feasibility as part of German Center for Sepsis Control \& Care (CSCC). All ICU patients of the Jena University Hospital, Germany will be screened for inclusion (severe sepsis or septic shock). Baseline data on ICU- and hospital care will be extracted from patient records at ICU discharge. The primary outcome is change in all-cause mortality from baseline to follow up at 6, 12, 24, 36, 48 and 60 months after diagnosis of sepsis. Follow-up data will be collected from the primary care provider of the patient. The registry may provide valid data on quality in sepsis care.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated in one of the ICUs will be enrolled if they were 18 years or older and fulfill the diagnostic criteria of severe sepsis or septic shock (ICD-10-GM, R65.0, R65.1) (19), (20).
* Diagnosis of severe sepsis or septic shock requires the following criteria: a microbiologically documented and/or clinically evident infection, at least two of the four criteria of the systemic inflammatory response syndrome (SIRS) and at least one new organ dysfunction, remote from the site of infection.

Exclusion Criteria:

-