cyrilzakka/clinical-trials huggingface dataset:
Autosomal Dominant Polycystic Kidney Disease (ADPKD) Study

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of renal failure. For several decades, ADPKD was regarded as an adult-onset disease. In the last decade, it has become more widely appreciated that the disease course begins in childhood. However, evidence-based guidelines on how to manage and approach children diagnosed with or at-risk for of ADPKD are lacking. Overall, there is insufficient data on the clinical course during childhood. The study intends to get more information on Autosomal Dominant Polycystic Kidney Disease (ADPKD) and other hepato/renal fibrocystic diseases. Additionally, the study intends to expand web-based resources so anyone can learn about ADPKD or other hepato/renal fibrocystic diseases. Individuals diagnosed with the dominant form of a hepato/renal fibrocystic condition are invited to be in the study.

This study will ask the subject's permission to see past, current, and future medical information related to the disease. Some information that is collected, would be clinic notes, lab results, and physician consult reports. The subject will be asked to sign a release of medical information form to allow the study team access to medical information.This study does not require a clinic visit to the center.

When the research study receives the information, the research study team will be able to enter the medical data into the Hepato/Renal Fibrocystic Diseases clinical database.

There will be initial data entry in the database and follow up data entries lasting for the duration of this study or until the subject chooses to not participate in the study anymore. The study team will remove the subject's name or any other identifiable health information from the received records before entering medical data into the Hepato/Renal Fibrocystic Diseases clinical database.

Eligibility Criteria:
Inclusion Criteria:

* Demonstration of ADPKD by clinical information, imaging studies, biopsy, autopsy, or genetic testing.

Exclusion Criteria:

* Patients with Autosomal Recessive Polycystic Kidney disease (ARPKD), urinary tract malformations or major congenital anomalies of other systems suggesting a diagnosis other than recessive hepato-renal fibrocystic diseases.
Safety and Efficacy of QAX576 in Adults With Moderate Persistent Allergic Asthma

This study will evaluate the safety and efficacy of QAX576 against asthma attacks in adults with moderate persistent allergic asthma


Eligibility Criteria:
Inclusion Criteria:

* History of asthma attacks
* Taking inhaled corticosteroids
* Non-smoking

Exclusion Criteria:

* Women of child-bearing potential
* History of respiratory disease other than asthma
* History of severe allergy to food or drugs
* Previous use of monoclonal antibodies
* Very low or high body weight

Other protocol-defined inclusion/exclusion criteria may apply.
Mindfulness-based Stress Reduction for Multiple Sclerosis

The primary purpose of this study is to assess the feasibility of mindfulness-based stress reduction (MBSR) for adults with any type of multiple sclerosis. The secondary objectives are to: 1) Explore the ability of MBSR to improve perceived stress and quality of life compared to an education control group; and 2) Explore the durability of the effects of MBSR over one year.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years of age or older
* Definite relapsing remitting, secondary progressive, or primary progressive MS by revised McDonald criteria;
* Expanded Disability Severity Scale ≤ 8 at baseline;
* Stable on MS disease modifying, anxiolytic, or antidepressant medications for three months prior to baseline visit;
* Mild to moderate stress defined by a score of ≥ 10 on the Perceived Stress Scale at screening;
* Ability to read and write in English;
* Willingness to provide informed consent and comply with study activities, including weekly MBSR sessions and daily practice or weekly Education Control classes.

Exclusion Criteria:

* MBSR or cognitive behavioral therapy training within the last 5 years;
* Current regular meditation or yoga practice (weekly or more often);
* MS exacerbation within 30 days of Baseline Visit;
* Mini-Mental Status Examination (MMSE) score of ≤ 26 at Screening Visit;
* Active suicidal ideation (Beck Depression Inventory) at Screening Visit;
* Reported or medically recorded diagnoses of current serious psychological disorders other than depression and anxiety;
* Other current life-threatening or severely disabling physical disorders;
* Positive pregnancy urine test at Baseline and women planning pregnancy during the study period (contraception not required);
* Cancer, other than basal or squamous skin cancers; or
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

This study will measure plasma concentrations of bivalirudin in pediatric patients undergoing cardiac catheterization, cardiac surgical procedures utilizing cardiopulmonary bypass (CPB), or extracorporeal support with ECMO, ventricular support devices (VAD) or lung-assist devices (LAD). The aim is to understand the pharmacokinetics of bivalirudin in these settings.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patient (age less than 18 years)
* weight \> 3kg
* scheduled to undergo 1) cardiac catheterization, 2)cardiac surgical procedure utilizing CPB, and/or 3) the institution of extracorporeal support
* must already require the administration of bivalirudin as part of their treatment plan

Exclusion Criteria:

* Age equal to or greater than 18 years,
* weight less than 3kg
* end-stage renal failure requiring renal replacement therapy.
Prophylactic Sodium Supplementation for Children Hospitalized With Pneumonia

The goal of this clinical trial is to study the impact of sodium supplementation on hospital outcomes of children with pneumonia.

It aims to answer:

* Does sodium supplementation lower the length of hospital stay in children with pneumonia?
* Does potassium supplementation lower the length of hospital stay in children with pneumonia?

Researchers will compare the intervention arm to a placebo arm to see if the intervention lowers the length of hospital stay.

Participants will:

• Take one sachet of oral rehydration solution (ORS) every day for 3 days.

The study is a randomized clinical trial that will be conducted on hospitalized children with pneumonia after considering exclusion criteria.

The enrolled children will be randomly divided into two groups. The intervention group will receive oral rehydration solution (ORS), and the placebo group will receive a placebo. Children will receive either the ORS or the placebo daily for 3 days.

All children will be followed until discharge from the hospital, and their clinical outcomes will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children aged between 1 month and 5 years.
* Patients diagnosed with pneumonia according to World Health Organization (WHO) criteria.

Exclusion Criteria:

* Children with other comorbidities.
* Those whose parents will show disapproval for the participation of the study.
* Children on medications that affect sodium and potassium levels.
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA

Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. More data is needed regarding emergency contraception containing ulipristal acetate. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but this protocol registration is for the UPA aspect of the study procedures.

Emergency contraception (EC) provides a woman with an additional line of defense against unintended pregnancy following an act of unprotected intercourse. Orally-dosed EC works by delaying ovulation and reduces the risk of pregnancy for a single act of unprotected intercourse by 50-70%. Unfortunately, obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed EC and in some instances EC is equivalent to placebo.

Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed EC in obese women. We hypothesize that increasing the dose of orally-dosed EC agents will normalize the pharmacokinetics resulting in the expected treatment effect (delay in follicle rupture) in obese women. In the overall proposal, we plan to perform detailed pharmacokinetic and pharmacodynamic studies of UPA-based EC in obese women and expand upon our preliminary findings of LNG-based EC. This protocol registration is for the UPA aspect of the study procedures focused on the pharmacokinetics and pharmacodynamics of UPA and will include a dose escalation intervention.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy women
* Aged 18-35 years old
* Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3 ng/mL or greater
* Subjects must have a BMI of \>30kg/m2 and weight at least 80kg or more OR a BMI \<25kg/m2 and a weight of less than 80kg.

Exclusion Criteria:

* Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
* Impaired liver or renal function
* Actively seeking or involved in a weight loss program (must be weight stable) pregnancy, breastfeeding, or seeking pregnancy
* Recent (within last 8 weeks) use of hormonal contraception
* Current use of drugs that interfere with metabolism of sex steroids
* Smokers.
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study II

The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

To characterize the acute effects of vaporized THC in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Eligibility Criteria:
Inclusion Criteria:

* At least one lifetime exposure to cannabis
* Good physical and mental health

Exclusion Criteria:

* Cannabis naïve individuals
* Major current or recent stressors
Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS)

This is an open label expanded access protocol for the treatment of up to approximately 250 adult patients with amyotrophic lateral sclerosis (ALS) who have difficulty swallowing oral riluzole tablets and may be able to derive benefit from treatment with an alternative oral formulation of riluzole.

Riluzole is indicated in the U.S. for the treatment of patients with amyotrophic lateral sclerosis (ALS). The commercially available dosage form is a 50mg oral tablet. This expanded access protocol (EAP) is designed to provide access to a dissolving tablet formulation of riluzole designed for sublingual (SL) administration, in patients with ALS who, in the opinion and clinical judgement of the treating physician, would benefit from treatment with BHV-0223.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed ALS of any type or duration
* Current or previous treatment with oral riluzole tablets, or patients who have never taken riluzole oral tablets, or patients who have successfully completed a clinical trial with BHV-0223 and were not withdrawn prematurely due to adverse events
* Swallowing difficulties, or patient or caregiver report choking one or more times per week, or investigator deems appropriate to treat with sublingual BHV-0223 because (s)he deems the patient cannot be satisfactorily treated with Rilutek®
* Adequate hepatic function

Exclusion Criteria:

* Patient with history of severe hypersensitivity reaction to riluzole oral tablets or BHV-0223
* Patient is known to have any other acute or chronic liver disease
Preterm Newborn's Behavioral Responses During Feeding With Gastric Tube

Preterm infants need aims of a tube named oral or naso gastric to grow until they acquire autonomy in suction-swallowing.

In fact, several modes feed by a gastric tube exist : using an electric syringe pump (continuous administration), or manual and individualization administration. In this second case, milk can be delivered by gravity, depending on the height the syringe is placed above the infant, or by manually pushing on the syringe. Milk can be administrated by nurses or by the parents after a learning period.

In this observational study, we would like to compare the preterm infants' behavioral during these different naso or oro gastric feeding modes by observing well-being signs and withdrawal signs (Dsilna grid) on video settings.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized at the University Hospitals of Strasbourg during October 2024 and October 2025
* Needing nasogastric tube feeding during at least 4 days
* With parents (legal representants) having expressed their agreement with the use of video recording in the framework of the current study

Exclusion Criteria:

* ORL malformations
* Neurological dysfunction
* Sedated infant
Test-Retest Reliability in DETECT

Healthy volunteers without concussion, currently participating in non-or-limited contact sports teams at Emory University will undergo Display Enhanced Testing for Concussion and mild traumatic brain injury (mTBI) (DETECT) on three separate days: at baseline, day 50, and day 90. Prior to enrollment participants will be allocated to the test-retest arm or the exercise arm.


Eligibility Criteria:
Inclusion Criteria:

* age \> or = 16
* eligible for active participation during the National Collegiate Athletic Association (NCAA) season or member of the 2011 - 2012 or 2012-2013 club team
* Participation in a non or minimal contact sport

Exclusion Criteria:

* \< age 16
* history of concussion in the previous 6 months
* any of the following: learning disabilities, attention deficient disorder, attention deficit hyperactivity disorder, depression or other psychiatric disorder, sleep apnea, seizure disorder, migraine headaches, previous central nervous system (CNS) surgery
* chronic drug or alcohol use; or drug or alcohol use with the previous 24 hours
* inability to complete the study protocol (90 days)
Early Movements as a Predictor of Future Developmental Delay

Cerebral Palsy (CP) is a major developmental problem. Major risk groups of CP, are preterm infants and multiple pregnancies. Previous studies using the General Movements methodology demonstrated early identification of CP, as early as 3 month of age. This method was implemented mainly on preterm infants this study goal is to enlarge the scope of the methodology to infants of multiple pregnancies. A second goal is to study early motor development and its future consequences by comparing the development of the infants of the same multiple pregnancy.

Cerebral Palsy (CP) is a motor development problem with a prevalence of 2 per 1000 live birth. There are many etiologies to the syndrome such as: brain malformations, infections during pregnancy, pre and perinatal, anoxic brain damage etc. A high risk group for these causes is preterm infants and infants of multiple pregnancies.

Major motor deficits or brain insults are recognizable at early weeks but most of them are more subtle and are recognized at the age of one to two years. The General Movements methodology was developed by Prechtl HF is aimed to identify motor development deficits as early as 3 month. The methodology is using video recording to describe a trajectory of the development of spontaneous movements between birth and 3 month. Deviation from the trajectory was highly correlated with future motor mal-development.

In our work we will study the motor development of infants of multiple pregnancies. These infants are one of the risk groups to develop CP. We will use the General movements methodology to identify CP as early as possible. It will generalize its predicative power to this risk group. Moreover, we will enlarge our knowledge of motor development by comparing the development of infants of the same pregnancy.

Eligibility Criteria:
Inclusion Criteria for preterm infants:

* preterm infant under 37 weeks
* Normal or intraventricular hemorrhage grade I at U/S examination
* No neurological family history
* No maternal drug use with neurological effect during pregnancy
* Normal prenatal history such as: no evidence of hypoxic ischemic encephalopathy
* No convulsions
* Normal karyotype
* No major congenital heart defect
* Dizygotic twins

Inclusion Criteria for full term infants:

* Normal physiological examination
* No neurological family history
* No maternal drug use with neurological effect during pregnancy
Pain Diabetic Peripheral Neuropathy（DPN) in China

To understand the clinical characteristics of DPN patients in China; To investigate the distribution of DPN patients with depression and anxiety symptoms; To investigate the related factors of moderate and severe pain in DPN patients; To investigate the treatment of pain and depression and/or anxiety in DPN patients.

Pain diabetic peripheral neuropathy (DPN) is a heavy global economic burden. An American observational study in 2013 showed that the total average annual adjusted direct medical cost/person for DPN patients was $4,841, and the total average annual adjusted indirect medical cost/person was $9,730. A retrospective study in the United States in 2015 showed that the total annual direct medical cost per person for diabetes was $6,632, DPN ($12,492), DPN ($27,931), and severe DPN ($30,755) were 4.6 times higher than those for patients with diabetes alone. According to the 2015 European survey, the total annual direct medical cost per person for DPN patients in the United Kingdom was €2,963 (£2,511), of which 40% was used for hospitalization.

At present, there are no studies on the population epidemiology, depression and drug use of DPN in China. This study mainly investigates the above problems.

Eligibility Criteria:
Inclusion Criteria:

* outpatients who are elder than 18 years old with history of type 1or type 2 diabetes
* The presence of symptoms, signs and/or electrophysiological evidence of diabetic peripheral neuropathy
* The patient presents spontaneous pain (continuous or intermittent acupuncture pain, electric shock pain, burning pain, etc.) or induced pain (sensory hypersensitivity, paresthesia, etc.)
* The pain lasts for at least 3 months
* Informed consent has been signed

Exclusion Criteria:

* Patients with other causes of neuropathic, non-neuropathic, or mixed pain: for example, cervical/lumbar degenerative diseases, arthritis, nerve root compression, paraneoplastic syndromes, cerebrovascular diseases, spinal diseases, other peripheral neuropathies (immunological, toxic, nutritional peripheral neuropathies, etc.)
* Dementia, substance abuse, etc., severely affect cognitive and communication skills
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems

Single center, prospective follow-up of previously implanted subjects

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems

Eligibility Criteria:
Inclusion Criteria:

1. Has undergone a revision for nonunion and/or hardware removal (i.e. all conditions resulting in poor quality proximal bone).
2. Subject is implanted with the PROFEMUR® Z Revision Femoral Stem at the time of their revision THA.
3. Subject is willing and able to complete required study visits or assessments.
4. Plans to be available through the 10 year postoperative follow-up visit.

Previously implanted bilateral subjects can have both THAs enrolled in the study provided:

1. the PROFEMUR Z Revision Femoral Stem was implanted in both,
2. all other aspects of the Inclusion/Exclusion Criteria are satisfied,
3. enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
4. the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study.

Exclusion Criteria:

1. Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol.
2. Subject has a PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 implanted in the enrolled THA.
3. Has or had an overt infection at the time of implantation.
4. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation.
5. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation.
6. Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable.
7. Subjects unwilling to sign the Informed Consent document.
8. Subjects with substance abuse issues.
9. Subjects with an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
10. Subjects who are incarcerated or have pending incarceration.
Clinical Evaluation of Laser Therapy Used as an Adjunct to Non-Surgical Treatment of Gum Disease

The use of lasers to treat various problems in dentistry is growing as it has in medicine. One application is the use of lasers to treat periodontal disease. It has been suggested that the laser may reduce the need for surgical treatment by reducing pockets. The goal of this study is to evaluate the effectiveness of laser treatment for periodontal disease. Laser therapy will be used in addition to traditional non-surgical scaling and root planing (deep cleaning). The information obtained from this study will provide an objective assessment of adjunctive laser therapy compared to conventional periodontal therapy and will attempt to show the benefits, if any, lasers can provide in the treatment of chronic periodontal disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or older (male or female)
* Healthy without systemic diseases that may adversely effect healing
* Not pregnant and no current plans to become pregnant
* No periodontal treatment in the previous 12 months
* No systemic antibiotic therapy in the previous 6 months
* At least two quadrants with periodontitis (ideally opposite side same jaw)
* Each quadrant must have two or more sites with probing pocket depths ≥ 5mm
* Each quadrant should include interproximal intrabony defect(s)

Exclusion criteria:

* Any systemic disease, medication, or habit known to adversely influence bone metabolism and/or wound healing:
* Poorly controlled diabetes (HbA1c \> 7%)
* History of bisphosphonate medications
* History of radiation therapy affecting the proposed treatment site(s)
* History of immunosuppressive medications (e.g. corticosteroids)
* History of tobacco use (current or past tobacco use within the past 1 year)
* Immune compromise caused by disease, treatment or other condition
* Recent history of periodontal surgery (within the previous 2 years)
* Recent history of scaling and root planing (within the previous 12 months)
* Any condition that contraindicates periodontal therapy including surgery