cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015 and Co-administration of BR1015-3 and BR1015-2 Under Fed Conditions

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of BR1015 and co-administration of BR1015-3 and BR1015-2 in healthy volunteers under fed conditions


Eligibility Criteria:
Inclusion Criteria:

* Those weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(Except for hormone drugs) from the date of consent to 14 days after the last administration and disagrees to provide their sperm or ovum.

  * Methods of contraception accepted in clinical trial: Combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.


Eligibility Criteria:
Inclusion Criteria:

* Naturally or surgically menopausal
* Vaginal pH greater than 5.0
* 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

* Evidence of endometrial hyperplasia, cancer or other pathology
* Abnormal PAP smear
* Uterine bleeding of unknown origin or uterine polyps
* Current vaginal infection requiring medication
* Use of hormonal medications
* Clinically significant abnormal gynecological findings other than signs of vaginal atrophy
Pre and Post Muscular Fatigue - DROP-JUMP TEST

Many studies have related the presence of dynamic valgus with several musculoskeletal injuries of the hip, knee and ankle. The weakness of the hip abductors is cited as one of the factors linked to this poor dynamic alignment of the lower limb, however, motor control can also be one of the factors responsible for the poor alignment of the lower limbs.


Eligibility Criteria:
Inclusion Criteria:

Women aged between 18 and 29 years body mass index between 18.5 and 24.99 sedentary irregularly active no pain no injuries (hip, knee, foot, ankle or lumbar spine) no neurological sequelae

Exclusion Criteria:

pain during the test
Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment

The present study is a double-blinded randomized clinical trial with a duration of 12 weeks.

The present study is a double-blinded randomized clinical trial with a duration of 12 weeks

. 60 patients with periodontitis stage 2-3, grade B-C, generalized will be allocated in the test (probiotic) and the control (placebo) group at baseline.

The intervention is non-surgical periodontal treatment, which will be applied at baseline and followed for 12 weeks.

Clinical measurements and sampling will be performed at baseline, week 6 and week 12.

Primary endpoint: Changes in microbial composition.

Secondary endpoints: Changes in clinical and immunological parameters

Eligibility Criteria:
Inclusion Criteria:

* Periodontitis stage 2-3, Grade B-C, generalized

Exclusion Criteria:

* • Use of systemic antibiotics within the latest three months.
Pilot Study: Hypovitaminosis D, Hyperparathyroidism and Hypomagnesemia in Patients With Congestive Heart Failure

People with heart failure may have low magnesium and low vitamin D levels. They may also have abnormally high levels of parathyroid hormones. Magnesium and vitamin D are important chemicals that are not routinely measured in blood tests. We are studying how many people with heart failure have low levels of magnesium and vitamin D. We are also studying how many people with heart failure have overactive parathyroid glands and if that is related to their vitamin D levels.

This is a single-encounter crossectional prevalence study in which demographic information, health opinion surveys and labwork are all obtained at one visit. There are no follow up visits, however, if abnormal lab results are discovered, participants will be notified via US mail.

Eligibility Criteria:
Inclusion Criteria:

* congestive heart failure

Exclusion Criteria:

* pregnant
* hospitalized within one month
* taking calcium, vitamin D or magnesium supplements
* proteinuria \> 1g/24h
* creatinine clearance \<35 (MDRD)
Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique

The main objective of the study is the comparison of the effective duration of hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical technique versus an conventional multi-port technique.

The secondary objectives are to compare the following between the two arms of the study:

1. the difference between the real discharge date and the theoretical discharge date
2. measures related to intraoperative bleeding
3. operating time
4. postoperative pain
5. quality of life
6. abdominal wall complication rates
7. rates of further surgery and rehospitalization
8. use of material resources in the operating room
9. average costs of hospital stay
10. Costs of rehospitalization at 1 year
11. Indirect costs

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up
* The patient is declared fit by the anesthetist for an intervention by laparoscopy

Exclusion Criteria:

* The patient is not available for 12 months of follow-up
* The patient is participating in another study or is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient is not insured or beneficiary of a health insurance plan
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient cannot read French
* Patient with a history of pelvic radiotherapy
* Patient with a history of pelvic surgery or serious risk of major adhesions
* The patient is pregnant
* Contraindications for anesthesia for either surgical technique
* Promontofixation or lymphadenectomy
* No associated procedure other than morcellation or vaginal suture for extracting the hysterectomy specimen, unilateral or bilateral oophorectomy
* The patient has a known or suspected allergy to polyurethane
* Extended hysterectomy for neoplastic disease
Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion of Esreboxetine

The purpose of the study is to learn more about how esreboxetine is handled by the body i.e. the absorption, metabolism and excretion of esreboxetine.


Eligibility Criteria:
Inclusion Criteria:

Healthy male subjects aged 45 to 65 years Body mass index (BMI=weight/height2) 18 to 30 kg/m2

Exclusion Criteria:

Any clinically relevant abnormality identified on the screening medical assessment Any condition possibly affecting drug absorption Subjects with exposure to significant radiation (eg serial Xray or CT scans, barium meal etc)or who have participated in a radiolabelled study in the past 12 months, or who have occupational exposure to radioactivity History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5ounces (150ml) of wine or 12 ounces (360ml) of beer or 1.5 ounces (45ml) of hard liquor) within 6 months of screening 12-lead ECG demonstrating QTc\>450mses at screening Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication
Evaluation of Screen Time and Digital Media on ADHD

1. Assess how different types of digital media influence inattention, impulsivity, and hyperactivity in children with ADHD.
2. Analyze the role of screen time duration, content type, parental supervision, and socioeconomic status in ADHD symptom severity.

Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most prevalent neurodevelopmental disorders in children, characterized by persistent patterns of inattention, hyperactivity, and impulsivity. Studies suggest that its prevalence has risen due to improved recognition and changing diagnostic criteria. Children with ADHD experience significant challenges in school performance, including difficulty sustaining attention, frequent careless mistakes, and trouble following instructions, all of which contribute to lower academic achievement and increased need for special education support. ADHD is linked to problematic eating behaviors, as irregular meal patterns, increased consumption of unhealthy foods, and a higher risk of obesity due to impulsivity and poor self-regulation. Beyond academics and nutrition, ADHD also affects sleep quality, emotional regulation, and social interactions, leading to increased behavioral issues and conflicts with peers and family members. The widespread use of digital media further complicates these challenges, as excessive screen time has been associated with exacerbating ADHD symptoms and negatively impacting cognitive and emotional development. These findings highlight the urgent need for targeted interventions to support children with ADHD across multiple aspects of their daily lives

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed children with ADHD, confirmed by DSM-5 and Gilliam ADHD rating scale. • Parental consent for participation.

Exclusion Criteria:

* Comorbid neurodevelopmental disorders (e.g., autism, intellectual disability). • Chronic medical conditions affecting cognitive or behavioral function.
Retrospective Multicentre Observational Study on the Incidence of Hyperoxia in Non-intubated Patients in Intensive Care in Belgium Study OxSIZgen

Oxygen is the most widely prescribed therapy in the ICU (intensive care unit) and can save lives in critical patients. While the deleterious effects of hypoxia are apparent and must be actively avoided, hyperoxia also has adverse effects. These include systemic, coronary and cerebral vasoconstriction; decreased coronary blood flow; pulmonary atelectasis and increased free radicals. Despite these deleterious effects, hyperoxia is common and frequent in the ICU (from 22% to 74%).

A recent meta-analysis published in "The Lancet" with more than 16,000 patients demonstrated an association between liberal oxygen therapy and mortality in critical patients. Other meta-analyses confirm its results with high quality data according to the authors.

A randomized controlled trial published in "The New England Journal of Medicine" comparing liberal versus conservative oxygen therapy showed no difference in mechanical ventilation days and mortality (The ICU-ROX, 2019). However, the difference in PaO2 between the two groups was very small and the PaO2 in the liberal group did not exceed 100 mmHg. In any case, conservative oxygen therapy is safe for critical patients.

The recommendations therefore recommend an oxygen saturation between 94-97% in critical patients and 88-92% in patients with COPD (Chronic Obstructive Pulmonary Disease) .

However, to our knowledge, no study has described the incidence of hyperoxia in non-intubated patients in the intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Patient having oxygen
* Not to be ventilated
* Being over 18 years old

Exclusion Criteria:

* Sickle cell disease patient
* Patient with pneumo/hemothorax
* Pregnant women, prisoners, denial of informed consent
* Patients who are related to an investigator
* Patients undergoing hyperbaric chamber therapy
* Patients with CO
* Patients on ECMO
* Patients with paracoate poisoning...
* Patients included in other interventional studies
Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which type of radiation therapy is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying different types of radiation therapy to compare how well they work in treating patients with stage I, stage II, or stage III prostate cancer.

OBJECTIVES:

* Compare the efficacy of neutron and photon radiotherapy vs hypofractionated intensity modulated radiation, in terms of a lower frequency of chronic complication rate (chronic toxicity and disease-free survival), in patients with favorable to intermediate prognosis, stage I-III adenocarcinoma of the prostate.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of disease (T1 vs T2 vs T3). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo neutron radiotherapy over 15-45 minutes 5 days a week for 2 weeks followed by photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks.
* Arm II: Patients undergo photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks followed by hypofractionated photon irradiation over 15-45 minutes 5 days a week for 2 weeks.

After completion of study treatment, patients are followed periodically for 5 years and then yearly thereafter.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

  * Stage I-III disease (T1-T3, N0, M0)
  * No clinical or radiographic evidence of metastasis

    * If prostate-specific antigen (PSA) ≥ 10.0 ng/mL and Gleason score is 7, a radioisotope bone scan must show no evidence of metastasis
    * No evidence of lymphatic or visceral metastases of the abdomen or pelvis on CT scan or MRI
* PSA ≤ 20 ng/mL
* Gleason score ≤ 7 (if stage T3 , score must be \< 7)

PATIENT CHARACTERISTICS:

Performance status

* Not specified

Life expectancy

* More than 10 years

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Endocrine therapy

* Prior hormonal therapy allowed provided it was initiated no more than 2 months ago, and may include the following:

  * Luteinizing hormone-releasing hormone agonists (e.g., goserelin, leuprolide)
  * Anti-androgens (e.g., flutamide, bicalutamide)

Radiotherapy

* No prior pelvic irradiation

Surgery

* No prior radical prostatectomy
Genomic Study for the Prediction of Efficacy and Adverse Effects of CD11a Monoclonal Antibodies(Raptiva)

The pathogenesis of psoriasis has evolved from epidermal hyperproliferation to immune dysregulation in recent years. A Th1 cytokine profile is universally found is psoriasis. Biologics targeting the immune system have become the focus of study. Raptiva (Efalizumab) is one of biologics indicated for the treatment of psoriasis, and is the first biologic approved for use in psoriasis in the EU (EMEA). In USA, it is the second biologic drug (after Amevive) for psoriasis. Raptiva is a humanized chimeric antibody of CD11a (LFA-1), which blocks the interaction of CD11and ICAM-1, thus preventing lymphocyte trafficking. It is used for moderate to severe chronic plaque type psoraisis. The first clinical trial of Raptiva in Asians iscurrently done in the department of Dermatology, National Taiwan University Hospital and the incidence of psoriatic arthritis (either de novo or aggravation of preexisting psoriatic arthritis) is significantly higher than previously reported in Western countries（30％ versus 7%，and personal communication with doctors in Hong-Kong and Singapore also reveals a similar safety profile. It seems likely that a racial difference is present. Monocytes play a central role in the pathogenesis of psoriatic arthritis. It is thus intriguing to study the pathogenesis of Raptiva-induced aggravation of psoriatic arthritis by comparing the difference of monocyes response in the presence of Raptiva between patients with and without Raptiva-induced psoriatic arthritis. In further study, the CD11a genomic polymorphism will also be investigated. The suudy can provide us with important information on how a novel monoclonal antibody like Raptiva can have both therapeutic and detrimental actions on psoriasis. The short term benefit of the study will be in pharmacogenomics and pharmacoeconomics, finding the best candidates for the expensive drug. The long term goal will be the clarification of the pathogenesis of psoriasis and psoriatic arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of psoriasis
Parents' Knowledge Toward Pediatric Dentistry

The aim of the study is to assess the Parents' Knowledge, Attitudes \&Awareness toward Pediatric Dentistry.

Primary teeth are the valuable assets of a child. In children, milk teeth/primary teeth play a vital role for eating, phonetics and esthetics. Primary teeth are also essential in the development of the mouth. They maintain the arch length within the jaw and provide guides for the eruption pathway of the permanent teeth.

Problems in primary teeth in the form of pain and swelling can cause distress to the child, leading to inability to chew or speak properly and even may affect the appearance of a child. Premature loss of primary teeth can cause an earlier eruption of permanent successors and interfere with the harmony of adult dentition resulting in crowding caused by shifting and or drifting of the teeth toward the extraction space. Moreover, psychological, morphological and functional problems may result from premature loss of primary teeth.

Most parents are unaware of the role a pediatric dentist plays in their child's life, and the importance of dental visits at an early age is underestimated as most believe that the milk teeth are going to exfoliate and it not worth paying much attention to. Even if a parent is recommended to take the child to a pediatric dentist, many may not consider doing the same since awareness of importance of primary teeth is less.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children aged 3 years- 12 years.
* Children with no previous dental treatment.
* Healthy children without any systemic diseases.

Exclusion Criteria:

* Refusal of participations.
Effects of Arts Engagement on Physical Performance, Cognition, Social Isolation, and Self-Perception in Older Adults

The purpose of this community-engaged project is to examine how taking part in different arts (dance \& music), compared to control (no arts) affects older adults' Health-Related Quality of Life (HRQoL using the Short Form-20(SF) form), physical performance (Short Physical Performance Battery-SPPB), cognition (using the Montreal Cognitive Assessment-MoCA), social engagement (National Social Life, Health, \& Aging Project-NSHAP survey), and perceptions of self (focus interviews).

In this Randomized-Controlled-Trial, 60 adults (20/condition) will take part in 20, 45-minute sessions (ballroom dance, ukulele/guitar playing, or control- i.e. social conversation), 2 times/week for 10 weeks.

While the investigators know that arts participation improves function in older adults, exact effects of different arts programs on health outcomes remains unclear.

The investigators plan to fill this gap by studying how different arts participation affect health outcomes.

The overall aim is to study how arts engagement helps older adults remain active and influences physical, psychological, and emotional functioning.

Eligibility Criteria:
Inclusion Criteria:

* Be healthy,
* \> 65 years of age and able to take part in learning music, or ballroom dance.

Exclusion Criteria:

* Presence of a co-morbid mental health diagnosis or other physical or behavioral challenges that the study staff assess as rendering the participant unable or unsafe to participate in the study.
Hip Fracture Impact on Vascular Events In Noncardiac Surgery patIents: a cOhort evaluatioN (Hip VISION): Pilot Study

Hip VISION (Pilot Study) is a Prospective Observational Cohort Study to evaluate the incidence of overall and cause-specific mortality among consecutive patients aged ≥ 18 years presenting with hip fracture to the Juravinski Hospital of the Hamilton Health Sciences. This pilot study will assess the feasibility of a larger prospective international cohort study. After eligibility has been confirmed and informed consent has been obtained, participants will be registered in the study. Troponin level, complete blood counts and serum creatinine level will be collected at day 1 through day 10 post admission. CAM instrument will be employed at admission and once daily post admission day 1 through day 10. FIM Instrument will be administered within 72 hours of admission to establish pre-fracture functional independence and disability. Patients will be contacted by research personnel by telephone 30 days after study registration.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 18 years with hip fractures (i.e. fractures involving the subcapital, femoral neck, or intertrochanteric regions), treated either operatively or non-operatively
2. Mechanism of injury consistent with either:

   1. A fall from a standing height or;
   2. Another mechanism of injury which, in the clinical judgment of an orthopedic surgeon, would impart the same or less traumatic energy as a fall from a standing height

Exclusion Criteria:

1. Patients with fractures isolated to the proximal femoral shaft, with no involvement of the intertrochanteric, femoral neck, or subcapital region
2. Patients with hip fractures resulting from high energy mechanisms, such as motor vehicle accidents or falls from a substantial height
3. Patient who refuse 30-day or 6-month follow up
4. Patients who refuse to consent either by themselves or through a substitute decision-maker (for patients unable to consent, we will use a deferred consent process, as described below).