cyrilzakka/clinical-trials huggingface dataset:
Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis

This study will look at participants body weight from the start to the end of the study. It will also look at how much pain participants have in participants knee from the start to the end of the study and how this affects participants daily life. This is to compare the effect on body weight and pain in the knee in people taking semaglutide with people taking "dummy" medicine. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance.

Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study, participants will have talks with study staff about how to eat healthy food and how to be more physically active. The study will last for about 1 ½ years. Participants will have 14 clinic visits with the study staff. At the first clinic visit participants will have a blood sample taken. Participants will have an X-ray of participants knee taken at the first visit. If participants have had an X-ray recently, this may not be needed.

At 6 of the clinic visits participants cannot take pain medications for 3 days before the visit. Participants cannot take part if participants have had a joint replacement surgery in participants knee. Participants cannot take part if participants have or have had diabetes. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age above or equal to 18 years at the time of signing informed consent
* Body Mass Index (BMI) equal to or greater than 30.0 kg/m\^2
* Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) with moderate radiographic changes (Kellgren-Lawrence (KL) grades 2 or 3 as per central reading) in target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees are equal target knee joint will be in the most dominant leg.
* Pain due to knee OA

Exclusion Criteria:

* Joint replacement in target knee
* Arthroscopy or injections into target knee within last 3 months prior to enrolment
* Any other joint disease in the target knee
To Demonstrate the Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-Fasting Conditions

To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under non-fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder

The primary objective of this study is to compare the efficacy of unilateral and bilateral neuromodulation tests at 1 month.

The secondary objectives of this study are to compare the following elements between a group of patients undergoing unilater modulation tests (standard procedure) and a group of patients undergoing bilateral neuromodulation tests (experimental procedure) (at 1 month): Pollakiuria, pad use, urge incontinence, symptom severity, % of patients not eligible for an implant, debimetry, tolerance, complications, quality of life.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 1 month of follow-up
* The patient understands and reads French
* The patient has symptoms of overactive bladder resistant to first-line treatments (physiotherapy, anticholinergics)
* The patient suffers from an overactive bladder confirmed by a urodynamic panel
* The patient suffers from an overactive bladder unassociated with bladder obstruction as confirmed by flowmetry
* The patient has primary (idiopathic) overactive bladder primary with normal urinalysis, abdominal and pelvic ultrasound, urine cytology + / - cystoscopy
* The patient has no bleeding disorders, or the disorder is properly controlled after treatment

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* Overactive bladder associated with bladder obstruction as determined by flowmetry
* Overactive bladder unconfirmed by urodynamic panel
* Overactive bladder secondary to another condition:
* vesical: urolithiasis, bladder polyp, interstitial cystitis
* pelivienne: tumor or inflammatory
* neurological: multiple sclerosis, brain tumor, epilepsy
* the patient has an uncorrectable bleeding disorder
Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants

We hypothesize that inhaled Furosemide will be an effective treatment in infants with acute bronchiolitis.


Eligibility Criteria:
Inclusion Criteria:

* Age: 0-12 months.
* Infants who are otherwise healthy
* Infants with chronic lung disease of prematurity (BPD) will be included, but will be analyzed separately.
* Parents signed a written informed consent.

Exclusion Criteria:

* • Other previous or co-morbidity, specifically: respiratory (other than BPD, like Asthma or Cystic Fibrosis), cardiac or renal disease or anomaly.
The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer

The primary objective of this study is to determine the percentage of patients with a plasma concentration of sunitinib remaining at equilibrium (\[Suni\]REq) greater than 100 ng / ml (effective concentration according to the current literature).

The secondary objectives of this study are:

* To describe the distribution of constitutional genetic determinants related to sunitinib pharmacokinetics, and to study their correlation with

  * the \[Suni\]REq,
  * the advent of toxicity,
  * the tumor response.
* To describe the variation in the \[Suni\]REq and the plasma concentration of the active entity remaining at equilibrium (\[ActEnt\]REq) at:

  * the interindividual level,
  * overtime, between chemotherapy cycles.
* To describe the variation in the ratio of the plasma concentration of the metabolite remaining at equilibrium (\[Metab\]REq) to the \[Suni\]REq at:

  * the interindividual level,
  * overtime, between chemotherapy cycles.
* To explore potential correlations between the \[Suni\]REq and

  * toxicity,
  * tumor response.
* To explore potential correlations between the \[ActEnt\]REq and

  * toxicity,
  * tumor response.
* To explore potential correlations between the ratio \[Metab\]REq / \[Suni\]REq and

  * toxicity,
  * tumor response.

Eligibility Criteria:
Inclusion Criteria:

* The patient was correctly informed concerning the implementation of the study, its objectives, constraints and patient rights
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has kidney cancer and should begin treatment with sunitinib (Sutent) at the time of inclusion

Exclusion Criteria:

* The patient started treatment with sunitinib (Sutent) before inclusion
* The patient is participating in another interventional study
* The patient has participated in another interventional study within the last month
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has a contraindication (or an incompatible drug combination) for a treatment used in this study
Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes

The purpose of this observational study is to assess the treatment and outcomes of patients with prediabetes in community-based clinical practices.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Diagnosis of prediabetes based on hemoglobin A1C and/or fasting plasma glucose
* Established patient of Principal Investigator's clinical practice
* BMI greater than or equal to 25 kg/m2
* Physically able to participate in a diabetes prevention program

Exclusion Criteria:

* Has prior diagnosis of diabetes
* Is pregnant or is planning to become pregnant in the next 6 months
* Is currently taking a medication prescribed for diabetes prevention
* Is currently enrolled in a formal diabetes prevention or weight loss program
Osteochondritis Dissecans of Knee Prospective Cohort

The Cohort is a multi-site prospective data collection study that will enroll any patient with diagnosis of knee OCD (confirmed by a standard of care x-ray or MRI). Patients will be followed for up to the next 50 years of their lives to study courses of care, disease progression, treatment/surgical options/results, and specific sports-related outcomes in athletic patients. Subjects will complete quality of life surveys as part of the Cohort. Course of care will not be affected.

Patients will be recruited and consented at the visit in which their eligibility is determined. Once a patient is eligible and provides informed consent, he or she will be in the study for up to 50 years, or until his or her OCD lesion is healed successfully.

At the initial visit, a subject will complete a basic medical history form, and three questionnaires: the IKDC Subjective questionnaire (ages over 18) or the PEDI-IKDC Subjective questionnaire (ages under 18); the KOOS questionnaire; and the Marx Activity Scale (adult) or Pedi-FABS Scale (pediatric). Patients will then continue with their normal course of care as determined by their surgeon and care team.

Mandatory surveys (same as above) will be collected from patients at 2 years, 5 years, 10 years, and 25 years. Patients who cannot return to clinic will have the option to complete the assessments and return in pre-stamped and addressed return envelopes provided by the clinical site the subject is a patient at. Any other follow-up visits between these time intervals will also be options for patients to complete these assessments, however patients will not complete them any closer than intervals 12 weeks apart in order to prevent redundancy.

Additionally, at the initial visit, the surgeon will complete a routine patient history and physical exam, which will be collected. Any surgical procedures or physical therapy a patient undergoes for treatment of his or her OCD lesion will also be documented and collected. At follow-up visits, surgeons will complete their own physical exam follow-up assessment forms, which will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of osteochondritis dissecans or focal articular cartilage defects as confirmed by x-ray or MRI

Exclusion Criteria:

* Non-confirmed diagnosis (i.e. patient does not yet have imaging confirmation)
Samsca PMS in ADPKD Patients

This is a Post-Marketing Surveillance study(PMS) of Samsca® tablets in actual use in cases to slow the progression of cyst development and renal insufficiency in accordance with Korean regulations on Risk Management Plan(RMP) and New Drug Re-examination. This survey is a post-marketing, prospective, single-arm, all-cases survey conducted on approved indication, usage, dosage.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older patients with CKD(chronic kidney disease) stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease.
2. Patients who need to be prescribed by Investigators who got registered in Risk Management Plan.
3. Patients who have agreed and signed on conditions specified in Risk Management Plan.

Exclusion Criteria:

1. Patients with known or suspected hypersensitivity to tolvaptan or chemically related structures such as benzazepines or to any ingredient of the drug
2. Patients requiring urgent intervention to raise serum sodium acutely.
3. Inability of the patient to sense or appropriately respond to thirst.
4. Hypovolemic hyponatremia
5. Concomitant use of strong CYP3A(Cytochrome P450, family3, subfamily A) inhibitors
6. Anuric patients
7. Volume depletion patients
8. Hypernatremia patients
9. Women who are pregnant or possibly pregnant and lactation
10. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
11. Patients who are applicable to permanent discontinuation criteria prior to initiation of Samsca® Tablets
Use of Melatonin for Neuroprotection in Asphyxiated Newborns

Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Hypoxic-Ischemic Encephalopathy (HIE) occurs in 3-5 per 1000 births. Only 47% of neonates have normal outcomes. The neurodevelopmental consequences of brain injury for asphyxiated term infants include cerebral palsy, severe intellectual disabilities and also a number of minor behavioural and cognitive deficits. However, there are very few therapeutic strategies for the prevention or treatment of brain damage. The gold standard is hypothermic treatment but, according to the literature, melatonin potentially acts in synergy with hypothermia for neuroprotection and to improve neurologic outcomes. Melatonin appears to be a good candidate because of its different protective effects including reactive oxygen species scavenging, excitotoxic cascade blockade, modulation of neuroinflammatory pathways.

The research study will evaluate the neuroprotective properties and the effects of Melatonin in association with therapeutic hypothermia for hypoxic ischemic encephalopathy.

It is a randomized double blind, placebo controlled trial on 100 neonates with moderate to moderately to severe hypoxic ischemic encephalopathy (HIE) . HIE infants are randomized into two groups: Whole body cooling group (N = 50 receive 72 hours of whole body hypothermia) and melatonin/ hypothermia group (N = 50; receive hypothermia and 5 daily enteral doses of melatonin 10 mg/kg). Serum melatonin and autophagy levels are measured at enrollment, daily during the hypothermic treatment, at day 5 and 7 for the two HIE groups.

aEEG will be performed for 72 hrs during the hypothermic treatment and the re-warming. MRI and Spectroscopy analysis will be performed between day 5 and 7 of. After hospital discharge the infants will enter a follow-up program consisting in periodic clinical and developmental assessments until 2 years of age corrected for prematurity. An expert psychologist and a neonatologist will assess neurodevelopmental outcome using the Bayley Scales III at 6-12-24 months of corrected age.

Eligibility Criteria:
Inclusion Criteria:

* gestational age \> 35 weeks and weight \> 1800 gr
* Apgar score \< 5 at 10 minutes o need for cardiopulmonary resuscitation at 10 minutes or evidence of base excess \> 12 mmol/L or pH \< 7,0 at initial blood gas analyses
* evidence of moderate or severa encephalopathy graded according to Sarnat\&Sarnat neurological evaluation
* abnormal amplitude integrated electroencephalography

Exclusion Criteria:

* suspected inborn errors of metabolism
* major chromosomal congenital defects
Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan

To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have the major site of the low back pain at the 12th thoracic vertebra or lower
* Patients who have had low back pain for at least two weeks

Exclusion Criteria:

* Patients who have a previous history or complication of rheumatoid arthritis, spondylarthrosis with negative serum reaction (ankylosing spondylarthritis, psoriatic arthritis), metastasis of tumor, Paget's disease, fibromyalgia, tumor or infection of spinal cord or intervertebral disc, or any other disease which can cause systemic pain
Surgical Intervention for Morbidly Obese Adolescents

The purpose is to study whether the positive effects from obesity surgery in adults also can be achieved when adolescent subjects are operated.

Our hypothesis is that the effects concerning weight loss, health improvement and improved quality of life will be as good in adolescents as in adults.

Severe obesity in the adolescence is a major concern since there is a constant rise in prevalence worldwide. There is a need of effective tools to treat those patients since the natural course with conservative treatment is very pessimistic. I. e. most of the subjects having a BMI \>40kg/m2 in the adolescence will remain morbidly obese also in their adult life.

The three largest centres in Sweden treating obese children (Stockholm, Gothenburg and Malmö) will offer patients fulfilling the inclusion criteria to be operated with laparoscopic gastric bypass. If not willing to be operated they could join the study as a control case.

Subjects will be investigated at the baseline concerning physical health status and existence of medical risk factors but also regarding their quality of life, eating habits and physical activity. They will subsequently be follow over a ten year period regarding these variables.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>40 kg/m2 or BMI\>35 with comorbidity
* Pass psychological evaluation
* Puberty status Tanner 4-5
* At least one year with active conservative treatment that failed

Exclusion Criteria:

* Lack of compliance
* Specific obesity syndrome as Praeder Willis
* Obesity due to brain injury
* Severe general disease
* Specific genetic defect (MC4R, Leptin deficiency)
Visual Attention Span Mobilisation for Dyslexia

The aim of the study is to evaluate the efficiency of the medical device MAEVAD in improving the reading skills of children with dyslexia.

MAEVAD is a digital therapy specifically designed to improve the visual attention (VA) span of children with dyslexia. Dyslexia is characterized by a specific and significant impairment in reading and/or writing production and spelling. Some profiles of children with dyslexia show a deficit in VA span, characterized by a decrease in the number of distinct visual elements that can be processed simultaneously. VA span plays a critical role in the acquisition of reading skills and specific knowledge of word spelling. Brain regions involved in visual-attentional skills are under-activated in dyslexic children with VA deficits and can be reactivated following specific and intensive VA span training.

In this study 150 children with dyslexia will be randomized in tow groups. On the first group children will be trained first with MAEVAD then with a control training that does not stimulate the VA span. On contrary, on the second group children will first perform the control training and then MAEVAD.

For each intervention the sessions will lasts 15 minutes. 5 sessions are planned per weeks for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* School children from CE2 to CM2, aged 8 to 11 years
* Dyslexic children with a VA span deficit (composite visual-attention span below the fifteenth percentile and a letter threshold above or equal to the twentieth percentile with the - - - Evadys(c) battery)
* Established diagnosis of Dyslexia
* Children whose parents/legal guardians have signed informed consent and agree to participate in the study
* Children whose first language is French or who have been educated in French since kindergarten
* Raven's Progressive Matrices score above the 20th percentile or a WISC IV or V Verbal Comprehension Index or WISC IV or V Perceptual/Fluid Reasoning Index above 85 or documented/objectifiable absence of intellectual deficit
* Child with access to a computer
* Normal or corrected vision and audition

Exclusion Criteria:

* Attention deficit hyperactivity disorder,dysphasia, dyspraxia, Autism Spectrum Disorder
* Neurological disorders
* Children who have missed 3 months or more of school in the current or previous year (excluding lockdown)
* Children not affiliated to a social security scheme
The Effectiveness of Clear Aligner and Traditional Fixed Appliances in Achieving Good Occlusion in Complex Orthodontic Cases

Patients who have severe crowding that requires four premolars extraction will be treated in this study. The efficacy and effectiveness of in-house clear aligners therapy compared with vestibular fixed appliances in the treatment of severe crowding malocclusion cases requiring the extraction of first premolars will be evaluated using Little's irregularity index (LII), Peer assessment rating index (PAR), and treatment duration.

There are two groups:

First group (Experimental): the patients in this group will be treated using clear aligners.

Second group (Control): the patients in this group will be treated using fixed appliances.

For years, orthodontists and dentists have used removable appliances for orthodontic treatment. With the CAD/CAM technology, clear aligners treat a broader range of cases with greater precision. They consist of a series of plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom-manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved.

Eligibility Criteria:
Inclusion Criteria:

* Class I skeletal and dental malocclusion
* severe crowding (more than 6 mm of tooth size-arch length discrepancy)
* Good oral hygiene and periodontal health.
* No congenitally missing or extracted teeth (except for the third molars).
* No history of previous trauma to the maxillofacial region or surgical interventions.

Exclusion Criteria:

* Subject with psychological abnormalities.
* Subject with systemic diseases.
* Previous orthodontic treatment.
* Subject has known allergy to latex and plastic
A Pharmacokinetic Study of CVX-096 (PF-04856883) in Healthy Volunteers

The purpose of the study is to further evaluate the PK characteristics of PF-04856883.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-