cyrilzakka/clinical-trials huggingface dataset:
Safety of Treatment of Uterine Fibroids With Asoprisnil

The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of asoprisnil 10 and 25 mg administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment
* Otherwise good health
* Premenopausal based on Estrogen and Follicle Stimulating Hormone levels
* Agrees to double-barrier method of contraception
* Adequate endometrial biopsy with no significant histological disorder

Exclusion Criteria:

* Any abnormal lab or procedure result(s) the study-doctor considers important
* History of a blood-clotting disorder
* Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away
* Significant gynecological disorder, such as endometrial polyp
Pilot Study of TearCare System - Long-Term Extension

The objective of the study is to evaluate the long-term clinical utility, safety, and effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye syndrome who had previously been treated with the TearCare System.


Eligibility Criteria:
Inclusion Criteria:

* Previously enrolled in the TearCare arm of the TearCare Pilot Study
* Reports dry eye symptoms within 3 months of the baseline examination with a Standard Patient Evaluation for Dryness (SPEED) score ≥ 6
* TBUT of \<10 seconds in at least one eye
* Willing to comply with the study, procedures, and follow-up
* Willing and able to provide consent

Exclusion Criteria:

* Any active ocular or peri-ocular infection or inflammation
* Recurrent eye inflammation within the past 3 months
* Ocular surgery, oculoplastic surgery, ocular injury, Ocular Herpes Simplex, or Herpes Zoster
* Ocular surface abnormalities that may affect tear film distribution or treatment
* Abnormal eyelid function in either eye
* Diminished or abnormal facial, periocular, ocular or corneal sensation
* Ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal dystrophies
* Systemic diseases resulting in dry eye (e.g. Sjogren's syndrome)
* Allergies to silicone tissue adhesives
* An absence or fibrosis of the Meibomian glands (e.g. ectodermal dysplasia).
* Unwillingness to abstain for the duration of the study from systemic medication known to cause ocular dryness (e.g. Accutane, antihistamines, etc.)
* Anyone who requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within the past 30 days.
* Unwillingness to washout and remain off certain dry eye medications for the duration of the study.
* Participation in another ophthalmic clinical trial within the past 30 days
* Co-existing conditions that could interfere with the assessment of safety or efficacy of treatment (e.g. macular disease, pregnancy, nursing, etc.)
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns

Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants. However, most of them could not proceed enteral feedings due to clinical instability in the first few days. Recent studies supports oropharyngeal administration as a potentially safe and effective delivery method for immunologic benefits and only small amount of colostrum could be administrated for immune therapy for extremely premature babies. The purpose of this study is to determine the beneficial effects of oropharyngeal administration of colostrum for immunologic aspects in extremely low gestational age infants and evaluated the safety of this method to extremely premature infants in the first few days of life.


Eligibility Criteria:
Inclusion Criteria:

* premature infant with a gestational age less than 28 weeks born at Seoul National University Hospital and admit to the Seoul National University Children's Hospital NICU immediately after birth
* parents of the infant signed to the informed consent form with voluntary agreement

Exclusion Criteria:

* infants with major congenital anomalies or chromosomal syndromes
* infants of mothers not willing to provide colostrum in the first week of life
* infants of mothers with known infectious diseases that may be transmitted through the breast milk such as HIV, hepatitis C or active TB
The Investigation of the Depression in Osteoarthritis

Studies have reported that the patient's psychological state such as anxiety, depression and other emotion affect the therapeutic effect of osteoarthritis, also may be the important reason for the poor knee joint osteoarthritis efficacy.

The aim of this study are firstly to investigate the depression status of patients with osteoarthritis. Secondly, the study will aim to assess whether osteoarthritis progression will affect depression status, ultimately, provide reference for clinical.


Eligibility Criteria:
Inclusion Criteria:

Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis and the 2010 Chinese Medical Association clinical criteria for knee osteoarthritis.

Exclusion Criteria:

Patients with rheumatoid arthritis patients with a history of depression before osteoarthritis pathogenesis patients who can't cooperate with related inspection and assessment Patients with mental illness
Screening for Albuminuria at the First Line for Early Identification of CKD

Early detection of kidney disease

Early detection and appropriate treatment of kidney disease is important as this may prevent future cardiovascular complications and end-organ damage more effectively than intervention in more advanced stages of disease. There is a well-established relationship between albuminuria and renal- and cardiovascular disease. Elevated albuminuria has a relatively high prevalence in the general population (5-9%). The prevalence of albuminuria is even higher in high-risk patients with diabetes Mellitus, hypertension, obesity, cardiovascular disease and lipid disorders. Adequate treatment of albuminuria, preferable at early stages can prevent both cardiovascular and renal disease progression. However, scarce epidemiological data show that albuminuria measurements are only conducted in a minority of individuals and disease recognition is suboptimal, even in high-risk groups. The current study aims to evaluate if and how early identification of chronic kidney disease by targeted screening of albuminuria levels is feasible in primary care (pharmacies and general practitioners) to optimally discover and treat patients with elevated albuminuria.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus (diagnosis or prescription for the disease based on the NHG guidelines)
* Adipositas (diagnosis)
* Hypertension (diagnosis or prescription for the disease based on the NHG guidelines)
* Cardiovascular disease (diagnosis, specified in protocol section 5.2.2)
* Lipid disorder (diagnosis or prescription for the disease based on the NHG guidelines)

Exclusion Criteria:

* Inability to understand and sign the informed consent form
* Pregnancy
The Effects of Breakfast on Mental Workload

The aim of the study is to investigate the influence of nutritive (high-protein or high-carbohydrate) and non-nutritive (low energy) breakfast on psychological and physiological responses of mental workload during multitasking in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* eats usually breakfast
* use computer mouse with right hand
* normal sleep-wake rhythm between 9 pm and 8 am
* in females hormonal contraception

Exclusion Criteria:

* gastrointestinal disease, diabetes or any other significant major medical morbidity
* milk allergy
* lactose intolerance
* smoking
* excess use of alcohol, coffee, tea, cola drinks (\> 10 doses/day)
* pregnancy and breast feeding
* no medication or dietary supplements influencing measured responses
* BMI \> 30 kg/m2 or \< 18 kg/m2
Ngenla Subcutaneous Injection Special Investigation

The purpose of this study is to learn about the long-term safety and effects of Ngenla. Ngenla is approved for treatment of GHD (Growth hormone deficiency) without epiphyseal closure under daily medical practice.

Registration criteria of this study are the patients who:

* Have GHD without epiphyseal closure and receiving Ngenla for the first time.
* Are boys less than 15 years or girls less than 13 years of age at the start of treatment with Ngenla.

All patients in this study will receive Ngenla according to the prescriptions. We will examine their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use.

Patients will be followed up from the date of first Ngenla treatment until November 30, 2027.

This is a multi-center cohort study in patients with GHD without epiphyseal closure receiving NGENLA® Subcutaneous Injection. The investigators complete the case report form (CRF) based on the information extracted from the medical record created in daily medical practice.

Eligibility Criteria:
Patients who satisfy all of the registration criteria are subject to this study.

Registration criteria

1. Patients with GHD without epiphyseal closure who receive this drug for the first time after the date of contract for this study.
2. Boys who are less than 15 years and girls who are less than 13 years of chronological age at the start of treatment with this drug.
Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire (NPSI)

Several studies have shown the efficacy of spinal cord stimulation in reducing the intensity of neuropathic pain. This efficacy is defined as obtaining relief of at least 50% of the preoperative pain intensity assessed by the visual analog scale or the digital pain scale. No study has evaluated the efficacy of stimulation specifically on the different components of neuropathic pain, only an overall improvement in pain has been described.

A specific questionnaire for neuropathic pain has been extensively validated in neuropathic pain: the Neuropathic Pain Symptom Inventory (NPSI).

Thanks to the multidimensional structure of this questionnaire, investigators propose to evaluate separately and in a much more specific way the efficacy of spinal cord stimulation in the short and long term on the different components of neuropathic pain and to define responders subgroups.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* With neuropathic pain:

  * confirmed (DN4 score\> 4/10)
  * going back to one year at least
  * refractory to well-conducted medical treatments
* Requiring spinal cord stimulation: the indication is validated by the multidisciplinary meeting (RCP Neuromodulation / Pain at Foch Hospital)
* Having given his non-opposition

Exclusion Criteria:

* Patient with sepsis
* Having no well-conducted prior medical treatment
* With uncontrolled psychiatric disorders (active psychosis, suicidal disorders, severe depression)
* with somatoform disorders
* addicted to alcohol or drugs or withdrawal syndrome
* Deprived of liberty or under guardianship.
Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Muscular Dystrophy.

This Study is single arm, single centre trial to check the safety and efficacy of Bone Marrow derived autologous cell(100 million per dose) for the patient with Duchenne Muscular Dystrophy.

Muscular dystrophy is a group of inherited disorders that involve muscle weakness and loss of muscle tissue, which get worse over time. Duchenne muscular dystrophy is caused by a defective gene for dystrophin (a protein in the muscles). However, it often occurs in people without a known family history of the condition. slowly progress diseases.it causes Muscle weaknesses, Difficulty with motor skills ,Progressive difficulty walking.Breathing difficulties and heart disease,Frequent falls,weak limbs,lose motor Function.Begins in the legs and pelvis, but also occurs less severely in the arms, neck, and other areas of the body.Trouble getting up from a lying position or climbing stairs.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Diagnose of Duchenne Muscular Dystrophy.
* Aged in between 6 to 25 Years.
* Willingness to undergo Bone Marrow derived Autologous cell Therapy.
* Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study.
* Ability and willingness to regular visit to hospital for protocol procedures and follow up

Exclusion Criteria:

* Patient who is not Diagnose of Duchenne Muscular Dystrophy.
* Patient with History of Immunodeficiency HIV+,Hepatitis B ,HBV and TPPA+,Tumor Markers+
* History of Life threatening allergic or immune -Mediated Reaction.
* the site of bone marrow aspiration potentially limiting Procedure.
* Alcohol and drug abuse / dependence.
* Patients with History of Hypertension and Hypersensitive.
Video-based Detection of Atrial Fibrillation

The project focuses on the evaluation of a novel, contactless monitoring technology to measure the blood pulsatile signal based on the video recording of an individual's face. The variability of the pulse rate is computed to identify the presence of atrial fibrillation (AF). We propose to enroll 315 patients with symptomatic AF, paroxysmal or persistent, who go through successful radiofrequency ablation or electrical cardioversion. A computer tablet will be used by the subjects at home during 14 days after their procedure to read emails, browse the internet and watch videos. Facial video recordings will be automatically acquired during these daily activities by the tablet device. The subject will be wearing an ECG patch during the follow-up period. The one-lead continuous ECG will be used as a reference to verify the presence of AF rhythm during facial video recordings. The primary aim of the study is to demonstrate the validity and robustness of the video-based technology to detect the presence of AF when facial videos are acquired by the patients at home.


Eligibility Criteria:
Inclusion Criteria:

* Men and women older than 18 years of age,
* Medically-managed for symptomatic AF (persistent or paroxysmal),
* In sinus rhythm after their ablation procedure,
* In sinus rhythm after trans-thoracic electrical cardioversion.

Exclusion Criteria:

* Implanted with a device (pacemaker, CRT, ICD) and a ventricular pacing requirement superior or equal to 70%,
* Known allergic reaction to adhesives or hydrogels or with a family history of adhesive skin allergies,
* Unable to cooperate with the protocol due to dementia, psychological, or other related reason,
* Refusing to sign the consent for participation,
* Unable to operate the device such as blind patients.
* Patients with Parkinson disease (or other central nervous system disorder/Tremor) who cannot record a stable video signal of their face.
* The subject was previously enrolled in the current study.
* The subject wears clothing covering the face, or uses facial makeup that will interfere with the quality of facial recordings.
* Subject does not have internet access at home and lacks the technology to participate.
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure

This is a feasibility study using a cross-over design to implement and compare a best practice alert (BPA) with an automated in-basket message to inform providers when a patient with heart failure and reduced ejection fraction (HFrEF) is not on appropriate medical therapy. The data from this pilot study will lead to a randomized controlled trial to compare the effectiveness of the BPA versus an automated in-basket message, versus usual care (no intervention).

An estimated 68,000 deaths per year nationwide can be attributed to gaps in care for patients with heart failure and reduced ejection fraction (HFrEF), with the majority being due to lack of mineralocorticoid receptor antagonists (MRA). Despite proven benefits in randomized trials, class I guideline recommendations, and published clinical performance measures, patients with HFrEF are often not on guideline-directed medical therapy (GDMT). While successful interventions for improvement in prescription of GDMT have often included multidisciplinary approaches with dedicated staff, the relatively high cost of hiring additional personnel has led to an interest in electronic health record (EHR)-based interventions. Prior studies on EHR-based interventions in this arena have mainly been conducted in the inpatient setting, which is limited to one encounter during acute hospitalization, a setting often complicated by renal dysfunction or hypotension that can limit prescription of MRA. The development and study of outpatient EHR-based alerts for HFrEF GDMT are needed. Two types of outpatient EHR-based interventions include best practice alerts (BPA) and automated in-basket messages. Both of these methods have limited data, with some studies showing benefit and others demonstrating provider fatigue and burnout. To our knowledge, there is no study that has directly compared these different types of EHR-based interventions.

This is a feasibility study using cross-over design at two outpatient clinics in a large health system to implement and compare a best practice alert (BPA) and an automated in-basket message to inform providers when a patient with heart failure and reduced ejection fraction (HFrEF) is not on appropriate medical therapy. The data from this study will lead to a randomized controlled trial to compare the effectiveness of the BPA versus an automated in-basket message, versus usual care (no intervention).

Eligibility Criteria:
Inclusion Criteria:

* Cardiologist visit
* Transthoracic echocardiogram with the most recent EF \>= 40%

Exclusion Criteria:

* Hypotension: SBP \< 95
* Hyperkalemia: most recent K \> 5.1, or any K \>5.5
* Renal dysfunction: eGFR \< 30
* Ventricular assist device
* Hospice care
Expanded Access for CC-486

This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486.


Eligibility Criteria:
Inclusion Criteria:

-Adult patients with documented acute myelogenous leukemia (AML) in their first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, who seek treatment with CC-486 as monotherapy to maintain their CR or CRi.

Exclusion Criteria:

* Patients with AML in CR/CRi who plan to proceed to or are waiting for a bone marrow transplant
* Patients who have received a bone marrow transplant for the treatment of AML
* Treatment of AML patients with relapse or refractory disease
* Pregnant or breast-feeding females
* Patient meets enrollment criteria and can participate in a disease-specific clinical trial
The Motor Neurological Soft Signs (MNSS) in Persons With Schizophrenia

The aim is to contribute to the knowledge of the relationship between Motor Neurological Soft Signs (MNSS) and schizophrenia, as well as to point out the implications and recommendations for clinical and rehabilitative practices, in order to contribute to the identification of these signs as potential facilitators of prevention and a better follow-up in the psychosocial rehabilitation processes of the person with schizophrenia.

The aim is to contribute to the knowledge of the relationship between Motor Neurological Soft Signs (MNSS) and schizophrenia, as well as to point out the implications and recommendations for clinical and rehabilitative practices, in order to contribute to the identification of these signs as potential facilitators of prevention and a better follow-up in the psychosocial rehabilitation processes of the person with schizophrenia.

It is therefore important to answer the following starting questions:

* How can MNSS be assessed and analysed in the Portuguese population with schizophrenia?
* How does the manifestation of MNSS differ between people with and without schizophrenia?
* Do the MNSS of people with schizophrenia vary according to their functionality level including the following areas of activity (Cognition, Mobility, Self-Care, Interpersonal Relations, Daily Activities and Participation) and their motor experiences?
* How can the information obtained by applying a validated assessment tool for this purpose be made operational as a procedure for psychomotor assessment and intervention with this population?

The following objectives have been defined to answer these questions, which guide the work:

1. Translate, adapt and validate the BMS instrument (Jahn et al., 2006) for the Portuguese population with schizophrenia;
2. Explore the relationship of MNSS with demographic variables (e.g.: age, gender, education), clinical-therapeutic variables (e.g.: age of diagnosis, number of hospitalizations, medication, type of support) and psychosocial variables (e.g.: functionality, satisfaction and well-being, motor experiences);
3. Test a multifactorial model of the relationships between MNSS, demographic variables, functional clinical-therapeutic and psychosocial;
4. Compare MNSS in people with schizophrenia and people from a healthy control group.

Eligibility Criteria:
Inclusion Criteria:

* Have a schizophrenia diagnoses

Exclusion Criteria:

* Have a motor disability
* Drugs consumer
Drug-Drug Interaction Study of TRK-100STP

The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120

Non-blinded, randomized and crossover study to evaluate pharmacokinetic interaction between TRK-100STP and AST-120 in different administration condition. Nonelderly adult volunteers will receive TRK-100STP with or without AS-T120 after meal. Safety parameters will concurrently be measured.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Body Mass Index (BMI) of ≥17.6 to ≤26.4 kg/m2 and weight of ≥50 to ≤80 kg

Exclusion Criteria:

* Clinical abnormal physical findings, including BP, pulse rate, ECG and laboratory assessments
* Receives any investigational medicine within 120 days before screening
* Recent blood donor