cyrilzakka/clinical-trials huggingface dataset:
Children Follow-up of PCOS Women

Polycystic ovary syndrome (PCOS) is a complex and frequent disorder with a heterogeneous clinical presentation varying throughout life, from birth up to post-menopause. Although mostly known for its reproductive consequences, PCOS is associated with metabolic abnormalities related to insulin resistance and obesity. Children born from PCOS mothers are considered to be at risk for early insulin resistance, leading to development of PCOS and metabolic abnormalities in childhood and adolescence. Obesity and insulin resistance are considered as states of low- and pro-inflammation associated with endothelial dysfunction. In addition, it has been shown that endothelial dysfunction develops from the first decade of life in response to genetic and environmental risk factors. Therefore, offspring of women with PCOS may be at increased risk for vascular disease later in life. Moreover, some evidence suggests that early life respiratory disease also contributes to later life cardiovascular consequences. The number of studies on offspring of PCOS mothers is low and a systematic follow up of children born form PCOS mothers has not been performed yet. the investigators propose a systematic evaluation of cardiometabolic and pulmonary health characteristics of children (aged 2,5-8 years) born from mothers diagnosed with PCOS. A saliva sample will be performed to determine the biochemical androgenic status of the children. Mothers of these children have undergone standardized phenotyping prior to conception; the investigators will therefore be able to correlate the metabolic status of the mother around the time of conception and the cardiometabolic and pulmonary health of their offspring.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Children
* Children participating in WHISTLER study or children of PCOS mothers
* Aged 2.5-4 years or 6-8 years

Exclusion Criteria:

* Language barrier
* Children with a history of a heart defect
* Children with a respiratory infection or respiratory infection two weeks previous to the visit are asked to reschedule the appointment.
* Residency outside the Netherlands
* Diabetes Mellitus type I
* Unresolved medical conditions
Implementation and Evaluation of a Rare Disease Algorithm to Identify Persons at Risk of Gaucher Disease Using Data From Electronic Health Records (EHRs) in the United States (Project Searchlight)

This is a three-phase study comprising both retrospective and prospective components, as follows:

Phase I: Deployment of Rare Disease Algorithm:

A diagnostic screening algorithm was developed using advanced analytical methods to identify patients who have an increased likelihood of having Gaucher disease. This tool will be applied to a health system's electronic health records (EHR).

The top 50 active patients per healthcare system will be identified as "highly ranked by the RDA" and moved to Phase II. As three to four healthcare systems are expected to participate in this study, between 150 to 200 persons are expected to be identified and included in Phase II.

Phase II: Retrospective review of medical records of highly ranked persons: The listing of persons highly-ranked by the RDA from phase I will be forwarded to the study team within each participating healthcare system. After reviewing the RDA reports and medical records of each highly ranked person, study site personnel will determine eligibility for Phase III based on the relevant selection criteria listed in the section below.

Phase III: Prospective diagnostic testing: Eligible persons (or their parent/guardian) from Phase II will be contacted and asked to provide consent for inclusion into the study. After consent is received, blood samples will be collected and sent for Gaucher diagnostic testing. Because of overlap in clinical symptoms between Gaucher disease and acid sphingomyelinase deficiency (ASMD), patients will also receive diagnostic testing for ASMD. Results will be shared with study site personnel, who will subsequently inform the study subject (and/or their parent/guardian, where appropriate) of results. It is anticipated that participation of a typical subject will be less than 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Phase I (Model Deployment): All persons within the EHRs of the selected IDNs will be included in this stage.
* Phase II (Case Ascertainment): The 150 to 200 persons with the highest RDA values (i.e., 50 per healthcare system) who are active (any documented interaction with the healthcare system in the previous 18 months) will be included in this stage.
* Phase III (Diagnostic Testing): The subset of persons from Phase II who: (1) have not been diagnosed with GD or ASMD, and (2) have not had GD and ASMD conclusively ruled out, will be asked to provide consent to undergo diagnostic testing. Individuals who meet these criteria and who provide written informed consent (or those whose parents/guardians provide consent as appropriate) will be included in this stage.

Exclusion Criteria:

* There are no exclusion criteria for Phase I or Phase II.
* Phase III (Diagnostic Testing):

  * Patient is unable/unwilling to provide informed consent for diagnostic testing, or
  * Patient is no longer under the care of the IDN

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Imaging Trial With I-124-CLR1404 in Patients With Newly Diagnosed or Recurrent Glioblastoma

The primary objective of this trial is to determine the optimal dose and imaging time point(s) of I-124-CLR1404 in subjects with newly diagnosed and recurrent glioma to be used in future trials.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed glioblastoma or recurrent/suspected recurrent glioblastoma
* scheduled to undergo a clinically-indicated surgery or biopsy (specific cohorts)
* ECOG performance status of 0 to 2 (Appendix C)
* 18 years of age or older
* has the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
* has the ability to read, understand and provide written informed consent for the initiation of any study related procedures (or legal representative)
* if female of childbearing potential must have a negative pregnancy test within 24 hours of enrollment
* Women of childbearing potential and men who are able to father a child, must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device, Norplant, Depo-Provera) during the study and for 45 days following the last dose of the study drug.

Exclusion Criteria:

* ongoing grade 2 or greater toxicities due to previous therapies. However, tolerable grade 2 adverse (e.g. neuropathy) events may be allowed at the discretion of the investigator.
* has following laboratory abnormalities

  * Platelets \< 100,000/μL
  * WBC \< 3000/μL
  * Hematocrit \< 22%
  * Serum creatinine \> 2.5 mg/dL
  * ALT \> 1.5 x ULN
  * Bilirubin \> 1.5 x ULN
* ongoing chronic immunosuppressive therapy
* history of hypersensitivity to iodine
* any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test drug
* women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
* pregnancy or breast-feeding
* inability to comply with the protocol
* use of any investigational drug within 4 weeks of dosing (unless a longer time period is required by local regulations or the investigational agent)
Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

Tanezumab is effective in reducing the pain associated with chronic pancreatitis.

On 23 Dec 2010 the FDA imposed a clinical halt for anti-NGF compounds due to safety reasons, ie, a case of osteonecrosis which occurred in relation to an anti-NGF compound of another company. All indications with the exception of Cancer Pain are affected resulting in termination of all studies in respective indications. Recruitment of Study A4091044 was stopped effective 27 Dec 2010. Two patients recruited so far did not receive further doses and were followed up for safety until LSLV on 22 Mar 2011.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female
* Written informed consent
* Diagnosis of chronic pancreatitis based on imaging studies
* Persistent abdominal pain due to chronic pancreatitis
* Qualifying pain score during the pre-treatment period
* Willing to comply with study visit schedule and study requirements including for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control

Exclusion Criteria:

* Pregnant women, lactating mothers, women suspected of being pregnant and women who wish to become pregnant during the course of the study
* Chronic pancreatitis as a complication of pancreatic cancer or acute pancreatic duct obstruction
* Pancreatic surgery, lithotripsy or endoscopist decompression within 3 months
* History of alcoholism (within 1 year of screening) or concurrent alcohol abuse
* History of cancer in the past years
* Significant cardiac disease within 6 months
* History, diagnosis or signs and symptoms of significant neurologic disease
* Disqualifying laboratory values including Hepatitis B or C, HIV and drug test
* Other medical condition that may interfere with study endpoints or safety of the patient as determined by the Investigator
* Known history of rheumatoid arthritis
* Avascular necrosis of the bone
* History of trauma to a major joint Evidence of osteoarthritis
Memantine for Executive Dysfunction in Adults With ADHD: A Pilot Study

This is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (Namenda) in the treatment of executive function deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD) receiving open-label treatment with OROS-Methylphenidate (OROS-MPH, Concerta). The study aims to examine the effects of treatment with memantine on ADHD symptoms. Following screening procedures, memantine is prescribed in randomized, double-blind fashion (equal chance of medication or placebo) for 12 weeks, along with open-label OROS-MPH (everyone receives medication).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults ages 18-50 years
2. A diagnosis of childhood onset ADHD, according to the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV) based on clinical assessment
3. A score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS)
4. EFDs as established by at least 2 abnormal (\>65) subscales of BRIEF-A

Exclusion Criteria:

1. A history of non-response or intolerance to methylphenidate at adequate doses as determined by the clinician
2. A history of non-response or intolerance to memantine at adequate doses as determined by the clinician
3. Pregnant or nursing females
4. A history of clinically unstable or significant other psychiatric conditions including suicidality, homicidality, bipolar disorder, psychosis, or current tic disorder, as judged by the clinician
5. History of narrow angle glaucoma
6. Current (within 3 months) DSM-IV criteria for substance abuse or dependence
7. Medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including cardiovascular disease, hypertension, history of renal or hepatic impairment, organic brain disorders, or history of seizure disorder.
8. Abnormal hematological or metabolic parameters
9. IQ \< 80
10. Current use of any psychotropic medication
11. Lack of facility with the English language
12. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
Evidence-based Nursing Practice in Surgical Clinics

It is aimed to examine the leadership status and work environments of nurses working in surgical units during the integration of evidence-based practices into the institution.

The study will be conducted with 248 nurses working in surgical units of three centers in Aydın, Isparta and Burdur provinces. Before the data collection begins, nurses will be informed about the study. The study data will be collected by researchers through face-to-face interviews with nurses every weekday between 15:00-16:00, so that the daily operations of the nurses and the institution will not be affected. The purpose of the study will be explained to the nurses who will participate in the study and the nurses who volunteer to participate will be asked to fill out the form. The form will take approximately 15 minutes to fill out. The study will question the sociodemographic characteristics of the nurses, their leadership status in the process of integrating evidence-based practices into the clinic, and the work environment and influencing factors.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Having worked in a surgical unit for at least six months

Exclusion Criteria:

* Not being a graduate of the nursing department
Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel

The almost single disadvantage of conventional polyurethane film dressings, an uncontrolled leakage, is probably as often described as its numerous advantages for split-thickness skin graft (STSG) donor sites. This shortcoming can be overcome by perforating the polyurethane dressing (MPD), which permits a controlled leakage into a secondary absorbent dressing. The study was conducted to compare the MPD-system and Aquacel® (ConvaTec), a hydrofiber wound dressing, which also seems to fulfill all criteria of an ideal donor site dressing.


Eligibility Criteria:
Inclusion Criteria:

* skin graft donor site anterolateral thigh
* men and women \> 18 years

Exclusion Criteria:

* informed consent missing
* repeated skin graft take or prior injury at the observed site
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
* History of hypersensitivity to the investigational products
Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain

This is an observational study aimed at evaluating the responsiveness and minimal important change of two measures of pain intensity in people with low back pain. It consists of a battery of self-administered questionnaires which will be given to individuals with low back pain to complete before and after a rehabilitation treatment. Relationships among the different outcome measures will be also evaluated.

This is an observational study aimed at evaluating the responsiveness and minimal important change of two different graphical ways to assess pain intensity in people with low back pain.

Literature found out that low back pain intensity is commonly assessed by a numerical rating scale ranging from no pain to the worst imaginable pain, once presented to responders horizontally. A different way to assess pain intensity could be to answer a similar numerical rating scale if set vertically.

In Literature there are not studies which head-to-head evaluate the responsiveness and minimal important change of these two ways of assessing pain intensity due to low back pain.

Participants will also have to complete self-reported outcome measures of disability, catastrophizing, fear of movement and self-efficacy, and correlations among these tools and the above two different ways to evaluate pain intensity will be evaluated. Descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample under investigation.

Eligibility Criteria:
Inclusion Criteria:

* Non specific low back pain
* Adult age
* Ability to understand the Italian language

Exclusion Criteria:

* Refuse to adhere to the study
* Definite causes of low back pain
* Central or peripheral neurological signs
* Systemic illness or psychiatric deficits
* Recent myocardial infarction, cerebrovascular events, or chronic lung or renal diseases
A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients

This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).


Eligibility Criteria:
Inclusion Criteria:

- Previously enrolled in the MIV-711-201 study including completion of Visit 8 either by

* Receiving MIV-711 200 mg and had non-significant clinical worsening on the primary endpoint as defined by a Numeric Rating Scale (NRS) increase of ≤2 OR by
* Receiving placebo and had a clinically significant worsening on the primary endpoint as defined by a NRS increase of ≥2

Exclusion Criteria:

* The presence of any inflammatory arthritis
* Any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator.
* Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study.
* Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
Chewing Function in Pediatric Neuromuscular Disorders

We aimed to evaluate chewing function (CF) in children with neuromuscular disorders, and investigate reliability of the Karaduman Chewing Performance Scale (KCPS).

Chewing disorders (CD) can be seen due to muscle weakness in children with neuromuscular disorders neuromuscular disorders (NMD). Normal diet consists of all food consistencies including liquid, pudding and solid foods, and CD causes inability to intake solid food. This condition can affect development, nutritional behavior and child-parent interaction in children. Thus, it is important to determine CD in an early period with appropriate assessment methods and plan appropriate therapies in NMD. We aimed to evaluate chewing function (CF) in children with NMD, and investigate reliability of the Karaduman Chewing Performance Scale (KCPS).

Eligibility Criteria:
Inclusion Criteria:

* Children above the age of 2 years
* Children with neuromuscular disorders

Exclusion Criteria:

* Children under the age of 2 years
* Children without neuromuscular disorders
Impact of Information Campaign's Alongside Maternity Staff About Bedding Infant

It is now well established that infants should be placed on the back only in a SleepSack without coverage or plush or pillow on a firm mattress in a bedroom. Despite these old recommendations of good practice, deviations are observed and some infants are most always lying according to the recommended position. The goal is to assess the impact of an information campaign of staffs maternity of the CHU of Reims on the practices of the sleeping of infants to motherhood, and then at the home of the parents.

Proposal for participation to the holders of parental authority of newborns eligible within 72 hours after the birth of the child. If acceptance of participation, the newborn will be included in the study. Participation in the study will not affect the medical care of the child. Participation in the study will consist of: a collection of data including the child sleeping mode, complete a questionnaire covering the child sleeping habits to motherhood and home during the 1st month of life. Information on the habits of sleeping in the home of the child will be collected via a phone call by an investigator. Inclusions will be held over 2 periods: one before and one after the completion of training of health care personnel regarding the sleeping of infants nursing staff training will consist of oral information by the investigative team and written information...

Eligibility Criteria:
Inclusion Criteria:

* born in reims CHU
* parents are 18 years old or more
* parents accept their participation in the study

Exclusion criteria :

* hospitalization in URIP / kangourou / neonatalogy
* needed baby warmer
X-396 Capsule in Advanced NSCLC Patients With ROS1 Gene Rearrangement

To assess treatment effectiveness and safety of oral X-396 capsule (Ensartinib) administered to Chinese patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a c-ROS Oncogene (ROS1) positive gene mutation (translocation or inversion).

This is a phase II, multicenter, single-arm study in which the efficacy and safety of X-396 capsule (Ensartinib) will be assessed in adult Chinese patients with ROS1-positive (rearrangement or inversion) non-small cell lung cancer (NSCLC). Approximately 69 patients (59 for never-treated, and 10 for previously treated with crizotinib) with locally advanced or metastatic NSCLC carrying ROS1-rearrangement will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Female or male, 18 years of age or older
* Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
* Positive for translocation or inversion events involving the ROS1 gene
* Tyrosine kinase inhibitor (TKI) treatment-naive or have previously received no more than one systemic treatment regimen(s) such as chemotherapy (After a 3-week washout period)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Predicted survival ≥ 3 months
* Drug related toxicities were relieved to grade 1, except for hair loss (based on NCI CTCAE v4.03)
* Adequate organ function
* At least 1 measurable tumor lesion as per RECIST v1.1
* Asymptomatic central nervous system (CNS) metastases do not require the use of steroids or anticonvulsants.
* Signed and dated informed consent
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
* Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment

Exclusion Criteria:

* Current treatment on another systemic anti-cancer therapy
* Prior therapy specifically directed against ROS1 fusion genes (except for the exploratory arm that will enroll patients pretreated with crizotinib)
* Evidence of active malignancy within last 3 years
* Previous therapeutic clinical trial must have completed at least 4 week prior to initiation of study drug
* Prior surgery or immunotherapy must have completed at least 4 weeks, and radiation must have been completed at least 2 weeks prior to initiation of study drug
* Known interstitial fibrosis or interstitial lung disease
* Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medication
* Clinically significant cardiovascular disease
* Patients with a known allergy or delayed hypersensitivity reaction to study drug or its excipient
* Pregnant or breast feeding
* Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers
* Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol
* Other serious illness or medical condition potentially interfering with the study