cyrilzakka/clinical-trials huggingface dataset:
A Study of BMS-986148 in Patients With Select Advanced Solid Tumors

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer, ovarian cancer, pancreatic cancer and gastric cancer.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin
* Expected to have life expectancy of at least 3 months
* Men and women 18 years old or older (or local age of majority)
* Must have measurable tumor per Response Evaluation Criteria In Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma
* ECOG of 0 to 1

Exclusion Criteria:

* Cancer metastases in the brain
* Moderate eye disorders
* Active infection or past hepatitis B or C infection
* Major surgery less than 1 month before the start of the study
* Uncontrolled heart disease
* Impaired liver or bone marrow function
* History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies, nivolumab or related compounds
Evaluation of New Custom Made Hearing Product Technology and Shell Modification

The purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products.

This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa.

The purpose of the studies is to evaluate the strengths and weaknesses of new custom product development in comparison to existing/old products. The results should promote the custom product development, to provide a maximum of benefit and wearing comfort to the hearing aid user.

Eligibility Criteria:
Inclusion Criteria:

* Only adult participants between 18 and 99 years
* lnformed Consent as documented by signature (Appendix lnformed Consent Form)
* Ability to fill in a questionnaire conscientious
* Healthy outer ear (w/o previous surgical procedures)

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product,
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* lnability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist
* Massively limited dexterity
* Psychological problems
* Central hearing problems
HOLT-ED: Holter-monitoring in End-stage Renal Disease

The main objective of this prospective cohort study is to assess arrhythmia burden and glycemic variability in a multicenter cohort of patients with end-stage renal disease using a sufficient observation period in order to identify arrhythmia burden and type and characterize associations with patient characteristics and dialysis treatment, glycemic variability and subsequent risk of adverse outcomes.

Background: The risk of dying of a cardiovascular disease is 10-20 times increased in patients dependent on dialysis treatment compared to the general population. 1/3 of these deaths is caused by arrhythmia and 'sudden cardiac death'.

Purpose: Investigate the prevalence and type of arrhythmia in patients dependent on dialysis treatment, including the association with patient- and dialysis related factors and cardiovascular outcomes.

Methods: 7-days Holter-monitoring with Cortrium C3+ holter-monitor in 540 patients dependent on dialysis treatment in the Capital Region of Denmark. Continous blood glucose monitoring in a subgroup. 1-year follow-up via national registers.

Endpoints:

* Prevalence of atrial fibrillation
* Prevalence of other arrhythmia (tachycardia, bradycardia, AV-block)
* Follow-up outcomes: sudden cardiac death, cardiovascular disease and cardiovascular death

Eligibility Criteria:
Inclusion Criteria:

* Dialysis-treated end-stage renal disease
* Age ≥ 18 years
* Competence to understand the study rationale necessary for written informed consent

Exclusion Criteria:

* Pre-existing pacemaker implantation
A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
* History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]).
* EASI score ≥16
* vIGA-AD score ≥3
* ≥10% body surface area (BSA) of AD involvement
* Worst pruritus numerical rating scale ≥ 4

Exclusion Criteria:

* Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
* Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:

  * Systemic corticosteroids
  * Systemic immunosuppressants
  * Phototherapy
  * Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

  * TCS of any potency
  * TCI
  * Topical phosphodiesterase type 4 inhibitors
  * Other topical immunosuppressive agents
  * Combination topical agents including TCS of any potency, TCI, PDE4 inhibitors, or other topical immunosuppressive agents
Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization

Summary:

Main Objective: to evaluate the efficacy of pelvic gonadal vein embolization with coils in treatment of pelvic congestion syndrome Methods: retrospective study included 25 patients in the University hospital of Brest.

The Primary Outcome Measure: To evaluate (to measure) pain relief using visual analogous scale (VAS) before and after gonadal vein embolization for pelvic congestion syndrome The Secondary Outcome Measures were to assess the impact of the treatment on specific and general symptoms through a survey.

A retrospective, non-invasive monocentric study of our Hospital 10-year registry (including data on MRI angiography and Vascular Doppler Ultrasound) of patients who have already undergone coil embolization of pelvic gonadal vein in treatment of pelvic congestion syndrome. These patients will be contacted by phone to participate in the study. An information letter will be handed out and the study protocol will be explained to the patients. After obtaining their written consent, they will be asked to fill out the study's validated questionnaire at home and return it to us through pre-paid regular mail. A face to face interview with the patient will be scheduled to assess the correlation between patient's clinical symptoms and survey results. There will be no change in patient's routine follow-up care.

All physician investigators of the study are experts in their field of medicine (e.g. interventional MRI angiography, vascular disease).

Eligibility Criteria:
Inclusion Criteria:

* Clinical symptoms of pelvic congestion syndrome documented by Vascular Doppler ultrasound and vascular dynamic MRI
* Failed medical treatment.
* \> 18 years \< 60 years old

Exclusion Criteria:

* \< 18 years old
* Under legal guardian
* Asymptomatic pelvic congestion syndrome
* Psychiatric disorder
* Endometriosis.
* Chronic pelvic disease
* Pregnancy
* Neoplasia
* Acute intermittent porphyria
The Influence of Degree of Head Elevation on Insertion Success for ProSeal Laryngeal Mask Airway Insertion

Background - The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSealTM laryngeal mask airway insertion

Methods

- This prospective randomized, controlled study included 80 adult patients . In the 3 cm (n=40) or 6 cm group (n=40), the PLMA was inserted while the head is placed on the 3 cm or 6 cm height of pillow. The success rate at first and second attempt, insertion time, blood staining on cuff, sore throat and hoarseness were assessed.

Background: The "sniffing position" (i.e., the neck flexed and head extended by means of a pillow) eases tracheal intubation because the three axes, namely, the axis of the mouth, the pharyngeal axis and the laryngeal axis, are put in almost a straight line. The benefit of the sniffing position that align three axis could possibly be applicable when the ProSeal LMA is inserted. For the endotracheal intubation, it has been recommended to elevate the patient's head 8 to 10 cm with pads under the occiput (shoulder remaining on the table) and extend the head at the atlanto-occipital joint to align the oral, pharyngeal, and laryngeal axes such that the passage and line of vision from the lips to the glottic opening are most nearly a straight line.

There have been several clinical studies about the effect of head and neck position including neutral, flexion or extension on the ease of LMA insertion.

However, it has not been much recommended or investigated about the influence of head elevation on the insertion success of PLMA until now. The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSeal laryngeal mask airway insertion in adult patients.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status 1-2
* scheduled for minor surgery in the supine position were enrolled

Exclusion Criteria:

* cardiorespiratory disease patients
* patients were at risk of aspiration
Deformable Image Registration for Breast Adaptive Tomotherapy

The radiotherapy treatment plan (also called dosimetry) used for all treatment sessions is based on the dosimetric scanner. During the sessions, the anatomy of the breast may vary, and these variations may impact the quality of the treatment. Adaptive radiotherapy is a new technique that allows these changes to be taken into account during treatment by automatically rescheduling the treatment for each session. The proposed trial aims to clinically evaluate one of these adaptive radiotherapy tools (PreciseART) based on deformable registration in order to determine if it can be used in daily practice in the treatment of breast cancer by tomotherapy. The trial will also clarify whether factors, such as duration of treatment, impact the quality of this algorithm.

The dosimetric scanner needed to calculate the dose to be delivered to the tissues will be carried out according to the standard practice. The treatment plan will be carried out by the physicist in accordance with the dose constraints and validated by the radiation therapist. Each treatment session is preceded by positioning imaging to ensure high precision in the treated area. During the first session, the acquisition of the positioning scanner will take into account the entire region of the target volume in accordance with the classic treatment protocol. Usually, the positioning scans of the remaining sessions are carried out on a smaller area around the operating bed in order to reduce the acquisition time. However, in the context of this study, mid- and end-of-treatment positioning scans will be acquired over the same exploration range as on the first day. These scanners will make it possible to compare the contouring work carried out manually by the radiotherapist and that obtained by the deformable registration algorithm.

Eligibility Criteria:
Inclusion Criteria:

Female

* With invasive breast carcinoma (or axillary lymphadenopathy whose pathological examination is compatible with the origin of breast cancer but without an identified primary breast tumor)
* Breast surgery (conservative surgery or mastectomy)
* Treated by (neo)adjuvant chemotherapy or hormonotherapy
* eligible to normo-fractionated breast radiotherapy in 25 sessions of 2 Gray or 15 sessions of 2.67 Gray, associated or not to bed irradiation whatever the delivered dose
* eligible to an irradiation of sus-clavicular, inner mammary chain or axillary lymph nodes
* With helicoidal tomotherapy

Exclusion Criteria:

* Absence of indication for breast radiotherapy
* Absence of indication for lymph nodes irradiation
* partial irradiation of breast
* in situ carcinoma
* intranodal isolated tumor cells
* radiotherapy on prosthesis or surgically reconstructed breast
* antecedent of breast irradiation opr homolateral lymh node irradiation
* bilateral breast cancer
Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

Rhinosinusitis disorders are almost regularly associated to Cystic Fibrosis (CF). The basic defect in CF is a dysfunction of chloride channels in exocrine glands which equally concerns upper airway mucosa. It leads to retention of secretions and consecutive chronic inflammation with bacterial superinfection.

In CF rhinosinusitis can restrict quality of life, give cause to repeated ear, nose, and throat (ENT) surgery and accelerate disease progression by bacterial acquisition into the airways.

The multicenter, randomized, double-blind, placebo-controlled, prospective clinical trial aims at the evaluation of a sino-nasal inhalation of sodium chloride 6% compared to isotonic saline with respect to ENT-related quality of life which is influenced by mucus retention and the resulting inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a confirmed diagnosis of cystic fibrosis based on: 2 positive sweat chloride tests and/or genetic characterization
* Subject is 8 years of age or older
* informed consent of the patient or legal representative
* Women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol (failure rate \<1% e.g. implants, combined oral contraceptives, injectables, some intrauterine devices, sexual abstinence or vasectomised partner)

Exclusion Criteria:

* Subject has no chronic rhinosinusitis (European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS-criteria)
* Subject has a critical condition defined as: forced expiratory volume at one second \< 30% and / or arterial oxygen saturation \< 93% without O2-substitution; need of O2-substitution
* Subject had an ENT surgery within 6 months prior to study
* Subject participates in another clinical trial within 30 days prior to study entry
A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products

This study is to see if there's any difference in the amount of facial irritation when two acne products are used together on one side of the face, compared to one acne treatment product used alone on the other side of the face. All people participating in this trial will be required to return to the same study center every weekday for two weeks for the investigator to check for irritation on the face and to have the products applied - on weekends they will have to put them on at home. If one side of the face is more irritated than the other side, a picture will be taken as well.

This is an investigator-blind, randomized, balanced study comparing two treatment regimens in a split-face model. All subjects will apply Retin-A Micro Gel (tretinoin) 0.1 % Pump, and Aczone Gel (dapsone) 5% daily to one side of the face (with 1 hour between applications, applying Aczone Gel first) and Retin-A Micro Gel 0.1 % Pump to the other side of the face in a randomized scheme for two consecutive weeks. Subjects will return to the study center daily for evaluation and for application of both products (weekend applications will be done at home). At each visit the subject will be evaluated and scored for irritation and cutaneous treatment effects. Subjects presenting with differences in irritation between one side of the face and the other will be photographed and have chromometer readings taken. A single treatment center is expected to enroll at least 24 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type I, II or III with healthy skin as judged by the investigator
* Bilateral skin is clear of any confounding irritation, rashes, acne, rosacea, etc., prior to study start
* Subjects are willing to avoid applying emollients or cosmetics to the face 24 hours before they start, and during the study
* If subject is of childbearing potential, subject has been using a protocol-approved method of birth control for a certain amount of time, and is willing to continue using it throughout the study

Exclusion Criteria:

* Subjects who are pregnant or nursing, or intend to be during the study
* Subjects with any condition or medical history, or using any drug or medication, that might negatively affect the subject's safety or the validity of study results, either as listed in the protocol or in the opinion of the investigator
* Subjects who have facial hair that may obstruct or hinder the evaluation of any reactions
* Subjects who use any known photosensitizing agents
Predictive Study on Acute Radiation Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients

Exploring effective risk prediction models for severe Radiation-Induced Oral Mucositis (RIOM/RTOM), providing a research basis for mitigating oral radiation toxicity, and effectively improving the sensitivity of dentists in predicting the risk of severe RIOM in locally advanced nasopharyngeal carcinoma patients.Based on precise radiotherapy, it is proposed to extract OAR using the contour of local oral areas. Explore more accurate RIOM dose-response relationships.Exploring a new type of fusion classifier, by complementing the information between each base classifier, helps to maximize the utilization of the information contained in different factors to build a more objective, reliable, and efficient multi criteria decision-making based risk prediction model for severe RIOM. It use predictive models to identify key risk factors for severe RIOM and further validate the effectiveness of this risk factor in reducing the risk of severe RIOM on risk factors for severe RIOM identified by the predictive mode.

This study investigates the prediction and management of Radiation-Induced Oral Mucositis (RIOM/RTOM) in patients with locally advanced nasopharyngeal carcinoma undergoing radiotherapy. RIOM is a significant concern due to its impact on the quality of life for patients and its potential to disrupt radiotherapy courses, affecting local tumor control rates. We systematically analyzed multifaceted data, including dosimetric parameters, clinical factors, and oral variables, to develop a predictive model for severe RIOM. The effectiveness of key risk factors in mitigating the risk of severe RIOM was further validated to predict and potentially prevent severe RIOM.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed as nasopharyngeal carcinoma through pathological tissue biopsy, AJCC 8th edition bed staging is I-Iva stage, with no distant metastasis
* First time receiving radical radiation therapy and receiving RTOM observation and treatment throughout the entire process in the Department of Stomatology
* Complete information on anti-tumor treatment materials
* No oral mucosal diseases that have not been effectively controlled in the past or still require long-term medication treatment
* Other diseases that do not affect the treatment of nasopharyngeal carcinoma

Exclusion Criteria:

* Failure to complete radiotherapy, or material release time delayed by more than two weeks compared to plan
* There are other diseases that affect the examination and treatment of oral mucosal inflammation, such as restricted mouth opening, Schegren's syndrome, etc
* Expected survival time less than 6 months
* Cases where patients withdraw from clinical trials at any time and for any reason
Accessing Peripheral Occluded LesiOns II (APOLO-II)

The current study is a prospective, single-arm, non-randomized, multi-center study to evaluate the outcome of the ENABLER-P Catheter System for crossing chronic total occlusions during endovascular intervention for femoral-popliteal occlusive disease.


Eligibility Criteria:
Inclusion Criteria:

* Documentation from a previous attempt OR a concurrent reasonable attempt (at least 5 minutes) during this procedure, demonstrating resistance to conventional guidewire crossing;
* Patient must have objective evidence of lower extremity ischemia;
* Totally occlusive lesion in a native femoropopliteal artery classified angiographically as absolute (100% occlusion with no flow), where no antegrade filling beyond the occlusion is visible;
* Target occlusion length is \>1cm and ≤ 30 cm;
* Patient's reference vessel diameter is ≥ 4.0 mm and ≤6.0 mm (by visual angiographic estimation)
* Patient must be an acceptable candidate for PTA, peripheral artery bypass surgery or peripheral artery stent implantation;
* Female patients of child bearing potential must have a negative pregnancy test within 48 hours prior to the study procedure;
* Patient must have been informed of the nature of the study, agree to its provisions, and provide written informed consent;
* Patient is ≥ 21 years of age.

Exclusion Criteria:

* Patient has hypersensitivity or contraindication to aspirin, heparin, Plavix or radiographic contrast agents which cannot be adequately pre-medicated;
* The patient requires immediate treatment in more than one occluded vessel, in any combination of grafts or native vessels;
* Patient has planned femoropopliteal intervention scheduled within 30 days after index procedure;
* The patient is currently participating in another investigational drug or device trial that may conflict with study data collection and has not completed the entire follow-up period;
* Patient has no collateral flow distal to the occlusion;
* Patient's target occlusion has a dissection that occurred within the past 30 days caused by a guidewire attempt;
* Patient has a history of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency;
* Patient suffered recent (within the past 6 months) significant gastrointestinal (GI) bleeding;
* Patient's target lesion or the vessel proximal to the target lesion reveals significant ectasia, dissection, aneurysm or thrombus;
* Patient has other medical illnesses (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with life-expectancy less than 1 year.