cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer

The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified.


Eligibility Criteria:
Inclusion Criteria:

* Women at least 18 years of age;
* Advanced AR+ TNBC;
* Availability of a representative tumor specimen:
* Either measurable disease or bone only nonmeasurable disease;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Any severe concurrent disease, infection, or comorbid condition;
* Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data;
* Current or previously treated brain metastasis or active leptomeningeal disease;
* Current hormone replacement therapy;
* Local palliative radiation therapy within 7 days before day 1;
* History of another invasive cancer within 5 years of day 1;
* Absolute neutrophil count \< 1500/µL, platelet count \< 75,000/µL, or hemoglobin \< 9 g/dL (5.6 mmol/L) at the screening visit;
* Creatinine \> 1.5 times upper limit of normal (ULN) at the screening visit;
* History of seizure or any condition that may predispose to seizure;
* Clinically significant cardiovascular disease;
* Active gastrointestinal disorder affecting absorption;
* Major surgery within 4 weeks before day 1;
* Treatment with any commercially available anticancer agent within 14 days before day 1;
* Treatment with any investigational agent within 2 weeks before day 1;
* Treatment with any of the following medications within 2 weeks before day 1: Estrogens, including hormone replacement therapy; Androgens (testosterone, dihydroepiandrosterone, etc);Systemic radionuclides (eg, samarium or strontium);Vaccine therapy;
* Hypoglycemic episode requiring medical intervention while on insulin treatment within 12 months before day 1;
* Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.
Effects of FES-Rowing in Neurological Disorders (FES-ROW)

The main objective of this project is to measure the increase in aerobic physical and metabolic capacities with a 6-month training on a rower assisted by electrostimulation of lower limbs in a population of adults with traumatic paraplegia.

Beyond the inability to walk, chronic paraplegic patients show an increase in their mortality from cardiovascular pathologies, compared to the same age groups of the general population. It is the hypoactivity induced by neurological impairment that is implicated in the first place in the pathogenesis of these abnormalities. The search for training methods adapted to these patients is justified to limit cardiovascular morbidity and mortality.

The aim of this project is to measure the increase in aerobic physical and metabolic capacities with a 6-month training on a rower assisted by electrostimulation of lower limbs in a population of adults with stabilized paraplegia (non-walkers), of traumatic origin.

Study is divided in two 3-month phases. The first consists on a training on a rowing machine with solicitation of the electrostimulated lower limbs only for a period of 3 months at the rate of 3 sessions of 30 minutes per week. The second consists on a training on a rowing machine with solicitation of the electrostimulated lower limbs and upper for a period of 3 months at the rate of 3 sessions of 30 minutes per week. The evaluations are composed of the measurement of maximum oxygen consumption, muscle and neurological parameters

Eligibility Criteria:
Inclusion Criteria:

* Paraplegia with traumatic origin
* Spinal cord injury AIS (ASIA Impairment Scale) score A and B at least 12 months old
* Patient having given written consent
* Patient with social security scheme
* Ability to obtain a leg extension with a 30-minute electrostimulation program

Exclusion Criteria:

* Protected adults (person in guardianship, curators or legal protection)
* Presence of contraindication criteria to carrying out a stress test or sustained physical activity decided by the doctor following the person with spinal cord injury.
* Drug treatment with cardiovascular or antidepressant effect
* Pressure sore
* Other associated neurological pathologies (stroke, peripheral neuropathy, myopathy, head trauma, ...)
* Affection of the shoulders of any etiology that could compromise the ability to use the rower.
* Spasticity of the lower limbs: Modified Ashworth Scale (MAS) greater than or equal to 2/4 (specifically quadriceps / Hamstrings)
* Participation in another study
The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical Procedure in Invasive Interventions

This study was conducted on the effects of visual and/or auditory distraction techniques applied to children aged 7-12 years who applied to Çanakkale Mehmet Akif Ersoy State Hospital Gynecology and Pediatric Emergency Service during invasive procedures (blood sampling, intravenous access or intramuscular injection in the deltoid region). Kaleidoscope, music concert, virtual reality glasses) is a randomized controlled experimental study to determine the effect of children on pain, anxiety and fear of medical procedures.


Eligibility Criteria:
Inclusion Criteria:

* The child is between the ages of 7 and 12
* Admission of the child to the pediatric emergency service for diagnosis and treatment
* The child's general condition is stable
* Deciding on one of the interventions such as blood collection, vascular access, deltoid region intramuscular injection after the examination, and the absence of any other invasive intervention planning
* The fact that the invasive intervention was performed in one go
* The child does not have vision and hearing problems
* The child has no pain (due to the disease, drug side effects, distension)
* The child does not have a chronic disease (kidney, diabetes, etc.) that will require frequent invasive procedures.
* The child's mental development level to be able to answer the questions asked
* The child and parent speak and understand Turkish comfortably
* The children and their parents are willing to participate in the research.
* Parents give written consent

Exclusion Criteria:

* The child has a history of epilepsy, vertigo and neurological disease
* Having a history of fainting during blood draw
* Having a disease that causes chronic pain
* Wearing glasses or hearing aids
* Complication development during invasive intervention (allergy, syncope, etc.)
* If the child is in danger of life and is taken to the very urgent patient examination room (resuscitation room)
* Deciding that the child is a forensic case after the examination
Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China

The objective of the study is to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients within 4.5 hours of symptom onset in a real-world clinical setting.

Recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has the logistic advantage of a single bolus infusion over recombinant tissue plasminogen activator (rt-PA) which needs a 1-hour infusion. The non-inferiority of rhTNK-tPA compared to rt-PA was proved by two recent randomized controlled clinical trials but the evidence is lacking regarding the real-world effectiveness and safety of rhTNK-tPA.

This is a multi-center, observational, retrospective study that enrolled acute ischemic stroke patients treated with rhTNK-tPA thrombolysis in China.

Eligibility Criteria:
Inclusion Criteria:

* all acute ischaemic stroke patients who met eligibility for thrombolysis with intravenous alteplase or TNK and presenting within 4·5 hours of symptom onset.

Exclusion Criteria:

* variables with a missing rate \> 40%
Soluble Corn Fiber Supplementation for Asthma

Studies of the importance of the human microbiome have demonstrated that microbial metabolites of fermentation of our dietary products (e.g. dietary fiber) have a multitude of health benefits. The investigators aim to determine whether supplementation of asthmatic children with soluble corn fiber alongside standard of care reduces airway inflammation driven by the gut microbial metabolites acetate, propionate, or butyrate (short chain fatty acids).

Asthma is a complex inflammatory disease of the airways that is estimated to affect 300 million people worldwide. Incidence of asthma is steadily increasing in Western populations; an additional 100 million asthma diagnoses are anticipated by the year 2025. Asthma is a multifactorial disease affected by genetic and environmental factors. One major and potentially modifiable environmental factor is the Western diet. The Western diet influences the microbiome, which in turn, may influence inflammatory airway diseases via a gut microbiome-airway connection. The investigators hypothesize that prebiotic dietary fiber supplementation leads to increased circulating short chain fatty acid production and improvement in asthma disease activity. The investigators will recruit 20 children, ages 6-17 years old, with asthma from the Severe Asthma Clinic or General Pulmonary Clinic at Phoenix Children's Hospital. Participants will be randomly assigned (1:1) using a random number generator to ingest PROMOTIR soluble corn fiber (85% fiber, 12 g/day) in a fruit-flavored beverage or placebo (malodextrin in a similar fruit-flavored beverage) as previously described. Participants will be asked to consume the prebiotic soluble corn fiber (or placebo) for 4 weeks alongside their normal diet and normal asthma treatments. Blood will be collected pre- and post-fiber intervention to measure baseline and post-intervention circulating SCFAs. Stool samples and nasal wash will be collected for microbiome and immune analysis pre- and post- fiber consumption. Nasal washes will be collected pre- and post-fiber consumption to measure inflammatory patterns.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of asthma
* Fractional excretion of exhaled nitric oxide (FeNO) \> 50 ppb OR a history of environmental allergies
* No emergency department or hospital visits for asthma in the past 3 months
* No systemic corticosteroids in the past 1 month
* Ability to consume a liquid drink of SCF or placebo
* Ability to return for a 4-6 week follow-up visit
* No special or unique diet as determined by PI/CO-Is.

Exclusion Criteria:

* Cystic fibrosis
* Bronchiectasis
* Change in asthma medicines other than short acting bronchodilators planned over the next 4-6 weeks.
Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS).

RATIONAL is a multinational, multicentre, observational, cross sectional study of adult patients in treatment with NSAID therapy for OA, RA or AS during for at least 2 weeks before study visit (at least one dose).

Prevalence study of gastrointestinal risk factors in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving treatment with non- steroidal anti- inflammatory drugs.

Eligibility Criteria:
Inclusion Criteria:

* Provision of subject informed consent.
* Female and/or male, aged \> 21 years.
* Patients diagnosis with RA (ACR 1987 or ACR/EULAR 2010 criteria), OA (ACR 1986, 1990 and 1991 criteria) or AS (New York 1984 criteria or ESSG 2002 criteria) (documented in the medical record).
* Patients receiving at least one dose of NSAIDs.

Exclusion Criteria:

* Participation in any interventional study involving investigational drugs.
* Patient refuses to fill in the study questionnaires.
* Pregnant or breastfeeding women.
* Patients with active neoplastic disease in the last 5 years, except basal-cell carcinoma.
Evaluation of the Use of the Atalante Exoskeleton in Patients Presenting an Hemiplegia Due to Cerebrovascular Accident

The INSPIRE study is interventional, European, prospective, open, multicentric, each patient being his/her own control.

It is conducted to assess the safety and performance of the Atalante exoskeleton system in patients presenting an hemiplegia due to cerebrovascular accident. The primary endpoint is defined by the reported adverse events.

The study will include 40 patients and takes place in six rehabilitation centers (4 in France, 1 in Luxembourg, 1 in Belgium).


Eligibility Criteria:
Inclusion Criteria:

* Patient with hemiplegia due to cerebrovascular accident, occurred two weeks ago or more, follow up in a rehabilitation center or in a hospital (inpatient or outpatient),
* Patient presenting a FAC score of 0, 1, 2 or 3,
* Patient whose etiological evaluation of the stroke has been complete,
* Adult patient ≥18 years old,
* Patient able to read and write in at least one of the languages of the country and who have signed an informed consent form.

Exclusion Criteria:

* Individuals with severe spasticity of adductor muscles, hamstring, quadriceps and triceps surae. Severe spasticity is defined by a score greater than 3 on the modified Ashworth scale,
* Pregnant women
* Individuals with history of osteoporotic fracture and pathology or treatment causing secondary osteoporosis,
* Pressure Ulcer of Grade I or higher according to the National Pressure Ulcer Advisory Panel (NPUAP) International Pressure Ulcer Classification System- European Pressure Ulcer Advisory Panel (EPUAP), in areas of contact with the Atalante system,
* Severe aphasia limiting ability to express needs or to fulfil questionnaires, at the discretion of the physician.
* Patient with a cardiac or respiratory contraindication to physical exertion,
* Patient with a score below 18 on the Mini Mental State test,
* Patient unable to deliver his/her consent,
* Patient under legal protection,
* Patient participating at the same time in another study,
* Patients with morphological contraindications to the use of the Atalante exoskeleton.
Laryngomicrosurgery Under NIDP General Anesthesia Supported by THRIVE

Laryngomicrosurgery requires deep paralysis and general anesthesia to finish the procedure. After the procedure, patients need a long time to recover. In the present study, with the support of the transnasal humidified rapid-insufflation ventilatory exchange, laryngomicrosurgery would be finished under nonintubated deep paralysis (NIDP) general anesthesia. In this case series study, the investigators will test the safety and feasibility of such a technique.


Eligibility Criteria:
Inclusion Criteria:

* elective polypectomy of unilateral vocal cord
* age between 18 to 40
* be able to communicate
* estimated operation time less than 15min
* ASA I-II
* Agree to sign written informed consent

Exclusion Criteria:

* pregnancy or breastfeeding women
* severe gastrointestinal reflex disease
* neuromuscular disease
* body mass index(BMI)\>30
* predictable difficult airway.
* allergy to medicine would be used in the present study including propofol, remifentanil or sugammadex
Smart Digital Denture Conversion (SDDC), a Technique for Full Arch Immediate Loading

This study presents a smart digital approach to design and construct a screw retained immediately loaded full arch implant supported bridge based on the pre-treatment complete denture.

After intra oral scanning of the ridge form, implant positions, the denture is used to scan the intermaxillary relation and tooth positions and the fixed interim is designed and milled from PMMA. This technique is applicable when a single arch is treated or for bimaxillary implant rehabilitation cases. In this study 30 patients were grouped into two groups; group I in which a converted denture was made conventionally and Group II in which a converted denture was made digitally. General satisfaction, chair side working time, and esthetic outcome of the prostheses were recorded and quantified with a verbal rating scale following insertion of implant-supported prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* -Nonsmokers
* Free from any systemic disease
* Non-bruxers
* With sufficient quality and quantity of bone
* Prepared to comply with the follow-up and maintenance program

Exclusion Criteria:

* - Patients with bad oral hygiene.
* Patients with limited mouth opening.
* Vulnerable groups.
* Uncooperative patients.
Evaluation of Osseo-integration After Placement of Dental Implants With Patients Receiving Radiotherapy for Buccopharyngeal Oncology

Follow up of implants with patients receiving radiotherapy for buccopharyngeal oncology. Implants will be placed 6 weeks before start of the radiotherapy or at least 3 months after the end of the radiotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving radiotherapy (6 weeks later or at least 3 months before) for buccopharyngeal oncology
Value of Anorectal Manometry Before Ileo- or Sigmoidostomy Closure After Rectal Resection

Background: High prevalence of fecal incontinence after rectal resection in patients with rectal carcinoma.

Hypothesis: Anorectal manometry done before ileostomy or sigmoidostomy closure can predict fecal incontinence.

Methods: Anorectal manometry before, 1 month and 6 month after closure. Anorectal endosonography before and 1 month after closure. Prediction of postoperative incontinence by the surgeon (digital sphincter examination). Visual analog scales for continence, subjective success of operation, and global well being; Wexner and Vaizey incontinence score; Parks incontinence classification; Rockwood fecal incontinence quality of life score; each before, 1 and 6 month after closure.


Eligibility Criteria:
Inclusion Criteria:

* all patients planned for ileo- or sigmoidostomy closure after rectal resection for rectal carcinoma

Exclusion Criteria:

* preoperative incontinence for solid stool
* dementia
* pregnancy
* latex allergy
Effects of COVID-19 Infection on Pregnancy Outcomes and Offspring Health

This is a large observational cohort study to assess the impact of COVID-19 infection on pregnancy outcomes and offspring health.

The influence of SARS-CoV-2 infection on reproductive outcomes has been uncertain. The goal of this observational study is to assess the impact of COVID-19 infection on pregnancy outcomes and offspring health for patients with childbearing needs.

Participants will:

1. Undergo a questionnaire to gather details on COVID-19 infection history.
2. Provide data about reproductive history.
3. Be invited for physical examination, laboratory tests and ultrasound scans.
4. Undergo a long-term follow up for pregnancy outcome and offspring health.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged between 18-50 years old.
2. Patients with signed informed consent.
3. Patients with complete COVID-19 infection information.

Exclusion Criteria:

1. Patients with abnormal karyotype
2. Recipients of oocyte donation.
Safety and Tolerability of Odanacatib (0822-059)

This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib


Eligibility Criteria:
Inclusion Criteria:

* male subject between the ages of 50 and 75 years; post menopausal female subjects between the ages of 45 and 75 years
* Subject is in good general health
* Subject has no evidence of metabolic bone disorder other than osteopenia or osteoporosis
* Subject is a non-smoker

Exclusion Criteria:

* Subject works night shift and is unable to avoid nightshift work during the study
* Subject has had major surgery, donated blood or participated in another investigational study with in the past 4 weeks
* Subject has a history of stroke, chronic seizures, or major neurological disease
* Subject has a history of cancer
* Subject consumes excessive amounts of alcohol or caffeine
Network Connectivity and Inhibitory Control Under Atomoxetin Challenge- A Pharmacological 'Resting State' and 'Inhibiton Task' Study in Patients With ADHD

Attention deficit /hyperactivity disorder (ADHD) is a disorder which manifests in childhood but often persists through adulthood. The most prominent symptoms in adults are inattention, emotional instability, disorganized behavior, impulsivity and restlessness, which cause several restrictions in different areas of life. It is suggested that those symptoms can be attributed to a general deficit in inhibitory control. This hypothesis is supported by several studies revealing that patients with ADHD show poor performance completing inhibitory control tasks.

Furthermore, studies showed that a unique administration of atomoxetin (ATX) significantly improves inhibitory control in patients with ADHD as well as in healthy participtants. In contrast to other medication authorized for the treatment of patients with ADHD, does ATX has no risk for potential addiction. Due its indirect mode of action, ATX has a delayed effect occurence taking up to 2 weeks. However, this apects was unconsidered in those studies.

Although we directly often associate failures in cognitive control with disruptions at prefrontal areas of the brain, there exists a specific brain network which is called the default mode network (DMN), which is suggested to be at least partly responsibe for the ADHD symptomatic.

The following study is interested in which way a 2- week intake of ATX affects the DMN and surrounding networks in their connectivity during a inhibitory control task and during rest in patients with ADHD vs controls.


Eligibility Criteria:
Inclusion Criteria:

* Male Age 18-45 years Diagnosis of ADHD (patients) or no axis I disorder (controls) according the DSM IV No substance abuse/ dependency Understanding of the study information and declaration of agreement Ability to read, understand and speak German No severe medical disorders No risk for suicide

Exclusion Criteria:

* Drug dependence or the a positive drug screening Other Severe physical disorders Current pharmacological therapy because of another psychiatric disorder Risk for seizure or cardiac problems Impaired liver and renal function Significant deviations in regard to clinical chemistry, haematology or EKG Relationship of dependency with the sponsor or the investigator Unable to keep to the study protocol Known Intolerance of the study medication fMRI scanner incompatibility
Clinical Assessment of Indirect Restoration Fabricated From Nano Hybrid Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth One Year Follow up

The aim of the study is to compare one-year clinical performance of indirect restoration fabricated from nano hybrid composite CAD CAM blocks and ceramic blocks

This research is conducted for comparing the clinical efficacy of nano hybrid composite blocks and ceramic blocks ., the choice of nano hybrid composite blocks based on the claim of the manufacturer, as it's considered to be promising , nano hybrid composite blocks has the highest fillers content (86% by weight), resembles natural teeth perfectly , Excellent physical values for flexural strength and abrasion, No firing required (a real one step ), can be processed using any conventional milling unit, can be finished and polished optimally, Ideal for grinding even in cases with thin edges.

Eligibility Criteria:
Inclusion Criteria:

* Patients with badly broken vital teeth
* Young adult Males or female
* Good oral hygiene measures
* Cooperative patients approving to participate in the study

Exclusion Criteria:

* Patients with a compromised medical history.
* Severe or active periodontal disease
* Severe medical complications
* Lack of compliance
* Endodontically treated teeth