cyrilzakka/clinical-trials huggingface dataset:
Rudolph: Nasal Microbiota With Red and Sore Nose

This pilot study will utilize the experimental rhinovirus infection model to study changes in skin microbiota in relation to skin erythema and soreness.


Eligibility Criteria:
Inclusion Criteria:

* self reported proneness to developing symptoms of nose redness and/or soreness
* sero-negative to HRV-16 at screening

Exclusion Criteria:

* confirmed or self-reported allergic rhinitis
* history of nasal or otologic surgery
* use of anti-inflammatory medication, recent antibiotics or anti-histamines
A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer

The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Have ED-SCLC and have received a prior platinum-based regimen
* Participants in Cohort 1 and in the addendum must have had an objective response to prior platinum-based therapy with subsequent progression ≥90 days after the last dose of platinum
* Participants in Cohort 2 must have either not had an objective response to prior platinum based therapy or had progression \<90 days after the last dose of platinum
* Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale

Exclusion Criteria:

* Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)
* Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids to treat CNS metastases
* Have previously completed or withdrawn from this study or any other study investigating prexasertib or a checkpoint kinase I (CHK1) inhibitor or have shown hypersensitivity to any of the components of the prexasertib formulation
* Have a serious cardiac condition
Prehospital Prediction of Large Anterior Vessel Occlusion

For the clinical benefit of intravenous thrombolysis "IVT" or intra-arterial thrombectomy "IAT" time is the most crucial factor. Reducing the time between stroke onset en treatment is therefore a major goal. Since IAT is only suitable for stroke due to large anterior vessel occlusion "LAVO" which is only performed in specialized comprehensive stroke centers "CSC", triage of LAVO-patients in the prehospital phase (i.e. in the ambulance) in order to directly allocate them to such a specialized CSC will save vital time (time=brain!). Several LAVO-prediction scales for clinical triage have been developed but most were tested in- hospital by experienced neurologists. Consequently, there is a great need for validation of these scales in the prehospital setting by Emergency Medical Services "EMS" personnel.

Objective: to recalibrate, validate performance and assess feasibility of several existing LAVO-prediction scales in the prehospital phase (i.e. assessment by EMS personnel).

Study design: multiregional, multicenter observational cohort study to investigate performance and feasibility of LAVO-prediction scales a.

Study population: all patients potentially eligible for IVTIAT according to the protocol used by EMS personnel except for when younger than 18 years.

The study will be conducted in two EMS regions: Hollands Midden and Haaglanden. In addition, all hospitals in these regions that treat over 30 patients per year with IVT will participate, including at least 1 CSC with IAT-availability per region. These hospitals are: Leiden University Medical Center "LUMC"; Alrijne hospital (location Leiderdorp); Haaglanden Medical Center (HMC+); Haga hospital; LangeLand hospital (LLZ) and Reinier de Graaf hospital (RdGG).

The observational design is pragmatic and reflects standard practice for acute stroke care.

inclusion: All patients with suspected stroke potentially eligible for IVT/IAT as estimated by the on-site EMS nurse.

A web based application is used that merely structures observations that are currently noted on transport charts. EMS personnel will have access to the web-based application via the iPad/tablet/smartphone/computer on which the EMS transport chart is already filled out as part of standard care. Or via their patient record as used in the ambulance.

The application will consist of the following items:

* EMS transport number
* time of symptom onset
* probability of LAVO estimated by EMS nurse
* 9-12 questions to structure clinical observations made by the EMS nurse.

The application will be straightforward and designed in close co-operation with EMS personnel. With the items acquired all prediction scales can be reconstructed.

Data of the application will be retrieved retrospectively and coupled with retrospectively collected data from the participating hospitals by a trusted third party

Eligibility Criteria:
Inclusion Criteria:

* Acute stroke code activated by EMS personnel

Exclusion Criteria:

* Age \<18 years
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study

The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.


Eligibility Criteria:
Key Inclusion Criteria:

* Subject is 22 years of age or older
* Subject has chronic low back and leg pain secondary to Failed Back Surgery Syndrome (FBSS)
* Subject has an average score of 6 or higher for average daily overall pain on the Numerical Rating Scale (NRS) based on the 7 day pain diary
* Subject has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes
* Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
* Subject agrees not to add or increase pain-related medication throughout the 12 week randomized evaluation phase of the study (starting at activation)

Key Exclusion Criteria:

* Subject currently participating in a clinical investigation that includes an active treatment arm
* Subject has been implanted with a previous neuromodulation system (PNfS, SCS-PNfS or SCS) or participated in a trial for a neuromodulation system
* Subject's overall Beck Depression Inventory II Score is \> 24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the baseline visit
* Subject with an infusion pump or any implantable neurostimulator device
* Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor)
* Subject has an existing medical condition that is likely to require the use of diathermy in the future
* Subject has peripheral vascular disease
* Subject is immunocompromised
* Subject has documented history of allergic response to titanium or silicone
* Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
* Female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)
The Sanderson Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening

This protocol is a prospective, case-control multi-center diagnostic study to assess the sensitivity and specificity of blood-based screening tests for the early detection of multiple cancers.


Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥30 years within 30 days of enrollment
* Able and willing to provide blood samples per protocol
* Able to comprehend and willing to sign and date the informed consent and HIPAA
* Authorization documents
* Able and willing to allow existing health data to be utilized for study purposes

Key Exclusion Criteria:

* Any history of solid organ or bone marrow transplantation
* Any physical trauma or surgery requiring inpatient overnight hospitalization in the 30 days preceding enrollment
* Received a blood transfusion in the 30 days preceding enrollment
* A medical condition that, in the opinion of the Investigator, should preclude enrollment in the study
* Known to be pregnant
* Any therapy for cancer, including but not limited to surgery, chemotherapy, biologic therapy, immunotherapy, and/or radiation therapy in the 5 years preceding enrollment
* Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 30 days preceding enrollment
* Participated or currently participating in another Freenome-sponsored clinical study
* For non-cancer groups: Any previous cancer diagnosis in the 5 years preceding enrollment; OR recurrence of the same primary cancer within any timeframe; OR concurrent diagnosis of multiple primary cancers within any timeframe
* For the cancer groups: Any previous cancer diagnosis in the 5 years preceding enrollment, apart from the current cancer diagnosis; OR recurrence of the same primary cancer within any timeframe; OR concurrent diagnosis of multiple primary cancers within any timeframe
Comparison of Two Gait Re-training Modalities During a Cardiac Rehabilitation Stay: Benefit of Orienteering Walking

Cardiovascular disease (CVD) is the leading cause of death in France for women and the second leading cause of death for men after cancer. They cause around 140,000 deaths every year, or almost 400 people every day throughout France. CVD also accounts for over a million hospital admissions a year, 160,000 of which are attributable to heart failure.

At present, cardiovascular rehabilitation centres mainly use exercise training methods based on sessions on cycloergometers and active walking (walking on a track and/or treadmill). Convinced of the added value of Orienteering, we have included it in our routine treatment as part of our Cardiac Rehabilitation programme, in addition to sessions on cycloergometers and active walking since 2021. As there is little literature on the subject in our population of interest, the aim of this study is to provide evidence of the relevance of orienteering in the cardiac rehabilitation programme.

We hypothesise that orienteering induces a similar cardiac response, amount of physical activity and perception of symptoms compared with an active walking session, while providing greater enjoyment of the activity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stabilised heart disease, coronary artery disease, heart failure, post-operative stay after cardiac surgery, congenital heart disease, patients at high cardiovascular risk and obliterative arteritis of the lower limbs;
* Who have been informed and do not object to the study;
* Over 18 years of age;
* Participating in a cardiac rehabilitation programme;
* With a walking distance of less than 3,600 metres;
* Able to understand and comply with the requirements of the protocol.

Exclusion Criteria:

* Pregnant or breast-feeding women
* Persons under guardianship or trusteeship
S100B Kinetic During the Occurrence and Treatment of Delayed Cerebral Ischaemia After a Subarachnoid Haemorrhage.

Nearly half of the survivors of subarachnoid haemorrhage (SAH) retain irreversible neurological damage resulting from the early lesions associated with the initial bleeding, and the occurrence of possible delayed cerebral ischaemia (DCI). The early diagnosis of the occurrence of an DCI is therefore a major challenge in order to optimise management before irreversible lesions are formed. However, the means of diagnosis are often not available, and up to a third of DCI are discovered on follow-up images when the lesions are already present. Among the markers of brain injury, S100 calcium-binding protein B (S100B) is an astrocyte protein released into the bloodstream at the time of the appearance of a brain lesion. Its short half-life makes it a prime candidate for patient follow-up to diagnose a new ischemic lesion and assess the effectiveness of its management.

Among the elements at the origin of DCI, the occurrence of proximal vasospasm is the main element on which we can have a therapeutic action. The strategy implemented in the department consists of performing a mechanical angioplasty when proximal vasospasm is detected with a decrease in downstream cerebral perfusion. Nevertheless the benefit of this therapeutic action is discussed and there is currently no early marker of the effectiveness of this procedure.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Patient hospitalised in the neurological intensive care unit for a subarachnoid haemorrhage.
* Delayed cerebral ischaemia suspected during routine care.
* Presence of a catheter (arterial or venous) for repeated sampling.
* Patient having been informed and having formulated his non-opposition or close to the patient having been informed and having formulated his non-opposition. In this case, the patient's non-opposition will be collected as soon as his condition allows it.

Exclusion Criteria:

* Pregnant or breastfeeding women in class.
* Patients under legal protection, guardianship, curatorship, under judicial safeguard.
* Patients participating in a study that may interfere with this study.
* Persons under psychiatric care under duress
Incontinence Surgery and Urodynamics Parameters

In patients who have previously had incontinence surgery due to stress incontinence (Midurethral slings (tvt, tot, etc.)), the symptoms may return in the following years and the patient can reapply with urinary incontinence. Urodynamic evaluation is important before stress incontinence surgery to confirm clinical diagnosis based on symptoms and findings and to determine the factors that may affect the effectiveness of surgery and the possibility of complications. Urodynamics evaluation is performed in the preoperative period in patients scheduled for incontinence. Urodynamics evaluation is performed again in patients who applied with post-operative recurrence due to surgery failure or different reasons.

It is aimed to show whether there is a difference between the urodynamics parameters of these patients who were examined preoperatively and the urodynamics parameters examined in case of postoperative failure. Thus, the primary goal; to show which of these parameters has deterioration or if the surgical method is insufficient if it is within certain limits or urinary incontinence may recur.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have previously undergone surgery for stress incontinence
* Those who are symptomatic again in their post-operative follow-up (urinary incontinence),
* Patients who underwent preoperative and postoperative urodynamics

Exclusion Criteria:

* Those with chronic diseases or medications that may cause urinary incontinence
* Patients with mixed or urge incontinence
* Patients who are not symptomatic postoperatively
Theatre in Adolescents With Chronic Medical Conditions (CMCs)

Investigators are building a program that uses improvisation to teach kids and teens with medical issues healthy ways to cope. Medical issues have been linked to anxiety and depression. Doing theatre can prevent these complications. Participants will meet in groups of about ten for ten weeks to do improvisation that is fun and supportive. Participants will meet with a study team member before the program starts, after the program ends, six months after the program ends, and twelve months after the program ends. At these visits, participants will be screened for anxiety, depression, quality of life, and will be given a short interview.

Adolescents with chronic medical conditions are at increased risk for anxiety and depression compared to other people their age. Therapies that use role-play prevent anxiety and depression. However, often these studies do not have an underlying psychological framework, or there is not enough information to replicate the program. Investigators designed an intervention using role-play based on Integrative Community Therapy, developed in the 1980s by Dr. Adalberto Barreto. This program will help adolescents with chronic medical conditions explore their feelings about issues related to having a chronic condition, learn new coping strategies, and help one another find support among peers.

This treatment will take place once a week for 10 weeks and investigators will compare the effects to those derived from improvisational theatre alone. To evaluate this new treatment, the study team will screen participants for anxiety, depression, quality of life, and will give a short qualitative interview. This will occur before and after the intervention, 6 months after the intervention, and 1 year after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Identify as having a CMC
* In grades kindergarten to 12th grade during the year recruited for the study

  * 5 years of age and ≤ 19 years of age at the start of the intervention
* Able and willing to participate in improvisational theatre in spoken English
* Able to understand and answer standard questionnaires used for evaluation in English (with or without accommodation)

Exclusion Criteria:

* None
Effect of Ankle Position and Pelvic Floor Muscle Force With Relaxation of Pelvic Floor Muscles Syndrome

Strengthening exercises of Pelvic Floor Muscles (PFM) is the first line treatment for female pelvic floor dysfunction. Actually the best position to facilitate PFM force is controversial in different studies. The aim of this study is to assess the effect of ankle positions on pelvic ﬂoor muscle force during PFM exercises.

This clinical trial study was carried out on 58 women aged 25-55 years with relaxation of pelvic floor muscles who referred to women's clinic of educational hospitals of Mashhad University of Medical Sciences in 1389. After clinical examination and confirmation of pelvic floor muscle relaxation, women were randomize divided into 3 groups, doing strengthening exercises of PFM in standing position with passive ankle dorsi ﬂexion (on wooden surface with 15 degree angle)(n=20), active ankle plantar ﬂexion with arm up (standing on toe)(n=20) and horizontal standing position (n=19) for 8 weeks. PFM exercises were instructed to women by using a pamphlet and face to face education. They were followed up every two week by telephone call and were asked to refer to women's clinic after 4 \& 8 weeks. Pelvic floor muscles strength was assessed with brink score before and after intervention. Data analyzed by using analytic-descriptive statistics.


Eligibility Criteria:
Inclusion Criteria:

* age 25-55
* bma 20-30
* women with relaxation of pelvic floor muscles syndrome in ph.ex and inspection

Exclusion Criteria:

* severe deformity in knee joint and ankle
* regular exercise or yoga
* severe or moderate vaginal atrophy
A Study to Evaluate the Efficacy and Safety of Meptin® Swinghaler® and Ventolin® MDI in Stable Asthma Patients

This is an open-label, randomized, cross-over, active-controlled study to evaluate the efficacy and safety effects using Meptin® Swinghaler and Ventolin® MDI in stable asthma patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male or females outpatients aged ≥ 16 years old with stable mild to moderate persistent asthma; Stability was assessed the patient remained in the same severity class (mild, moderate) and had no acute exacerbations by investigator judgment during the past 14 days;
2. Pulmonary function test:

   * Improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist before the study or ;
   * Positive result of Broncho-provocation test (PC20 ≤ 32 mg/ml) before the study.
3. Baseline forced expiratory volume in one second 60% ≤(FEV1)≤ 90% of predicted value on entry of the study;

Exclusion Criteria:

1. Hypersensitivity to β2-agonist or lactose;
2. Hospitalization due to asthma during the previous 3months;
3. Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
4. Oral or systemic corticosteroids in the previous 4weeks;
5. Inadequately controlled hyperthyroidism;
6. Severe hepatic or renal or cardiovascular disease as judged by the investigator;
7. Patients receive an investigational drug within 30 days prior to admission to the study;
8. Patients with significant alcohol, drug or medication abuse as judged by the investigator;
9. Females who are pregnant or breast-feeding; (exception: Females of child-bearing age might be included, if in the opinion of the investigator, they are using adequate contraceptive precautions).
Improvement in Quality of Life and Pain Scores After Laparoscopic Management of Deep Infiltrating Endometriosis

This is a retrospective cohort study that evaluates the postoperative pain findings of a consecutive series of laparoscopic surgeries for deep infiltrating endometriosis (DIE).

The study was carried out in university hospitals (Istanbul, Turkey). Patients diagnosed through bimanual gynecologic examination, gynecologic ultrasound or magnetic resonance imaging-confirmed endometrioma and DIE together; who underwent a laparoscopic surgery by a team of gynecologists, colorectal surgeons, and a urologist were retrospectively evaluated. The data were collected in a specific database and analyzed for postoperative pain outcomes through a comparison with preoperative symptoms scored using a visual analogue score (VAS), and the British Society of Gynecologic Endoscopy (BSGE) pelvic pain questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients with deep infiltration endometriosis and endometrioma diagnosed through bimanual gynecologic examination, gynecologic ultrasound or through laparoscopically confirmed endometrioma and DIE together;
* DIE with bowel involvement that required shaving or segmental resection for colorectal lesions and nodules;
* Who completed the VAS score and BSGE questionnaire;
* Follow-up period of at least 3 months;
* Patients resistant to medical therapy (NSAIDs, OCPs, levonorgestrel-releasing intrauterine device (IUD), and progesterone) or refuse to use medical therapy.

Exclusion Criteria:

\*Any other endometriosis patient that do no meet the inclusion criteria