cyrilzakka/clinical-trials huggingface dataset:
Development of an Algorithm to Denoise HFNO-generated Tracheal Sound

This study aims to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.

During deep sedation without intubation, anesthesia respiratory care and monitoring are of utmost importance. Anesthesia can lead to adverse respiratory effects, increasing the risk of airway obstruction and respiratory depression. High-flow nasal oxygen (HFNO) systems are often used to mitigate these risks. Monitoring tracheal breathing sounds directly using amplification provides better detection accuracy. However, traditional auscultation instruments have limitations, including noise interference and lack of visual functionality. The Airmod Smart Respiratory Monitoring System, with FDA approval in the United States and Taiwan, addresses these issues. It offers respiratory sound recording, noise filtering, event logging, and respiratory rate analysis. Currently, no digital stethoscope on the market can filter out HFNO noise. Therefore, the current study is to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective gastroinestinal endoscoy requiring deep sedation

Exclusion Criteria:

* Histories of sleep apnea, chronic obstructive pulmonary disease, or oropharyngeal tumor
* Patient who has a hisotry of previous intraoral surgery, tracheal surgery or pulmonary resection surgery
Cognitive Bias Modification for OCD

This study will conduct the development and preliminary evaluation of Cognitive Bias Modification for Interpretation (CBM-I) and Approach Avoidance Training (AAT) as augmentations to treatment as usual for OCD and related disorders. CBM-I refers to computerized interventions designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. In AAT, automatic approach tendencies toward feared stimuli are re-trained. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I and AAT.

Adults with obsessive compulsive disorder (OCD) and related disorders will be recruited from a treatment program for these disorders and participants will be randomly assigned to either receive: 1) eight sessions of CBM-I or eight sessions of psychoeducation as a control condition, or 2) AAT or eight sessions of an inactive (sham) version of the AAT training.


Eligibility Criteria:
Inclusion Criteria:

* Currently receiving treatment at the McLean Hospital OCD Institute
* For CBM-I condition only: report a score of at least 131 on the Obsessive Beliefs Questionnaire-44 upon admission to the OCD Institute
* For AAT condition only: endorse score of at least 7 on the DOCS subscale #1 (contamination subscale) upon admission to the OCD Institute
* Able to complete a computer task for 20 minutes
* Consent to main OCD Institute study protocol

Exclusion Criteria:

* Currently undergoing electroconvulsive therapy (ECT)
* Current symptoms of acute mania or psychosis
* A reported diagnosis at admission of a psychotic disorder
* History of traumatic brain injury
A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers

The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects.

This is a Phase Ia study of CUG252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.

Eligibility Criteria:
For healthy subject cohorts,

Inclusion Criteria:

* Non-smoking adult healthy male and female, aged 18 to 65 years (inclusive), at the time of consent with a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive), at Screening.
* Healthy as determined by medical history, physical examination, vital signs, clinical laboratory safety tests, ECG, and chest X-ray

Exclusion Criteria:

* Active bacterial, viral, fungal infection or known inflammatory process, infection or antibiotic treatment
* Laboratory test results outside the local reference range and deemed clinically significant
* History of chronic medications, immunosuppressant or steroids
* History of malignant neoplasm
* History of relevant atopy
* History of hypersensitivity to biologic agents or any of the excipients in the formulation.
* Excessive xanthine consumption
* History of drug or alcohol addiction or dependence within 1 year
* Positive of a tuberculosis test or a history of tuberculosis
* Abnormal blood pressure and/or ECG parameters
* Any prescribed medications within 28 days or nonprescription drugs within 7 days
* Previously received aldesleukin or any other IL-2 derivative
Part-time Versus Full-time Spectacles for Myopia Control (ParMA Study)

The purpose is to assess the effect of part-time compared to full-time spectacle use in juvenile myopia control.

A prospective, randomized, controlled clinical trial was designed for assessing the effect of single-vision spectacles on myopic progression. 30 myopic subjects, aged 6-16 years old, with a spherical equivalent refraction between -0.50D and -6.00D, were recruited. A random number table was used to allocate participants into either a) part-time use of single-vision spectacles, or b) full-time use of single-vision spectacles. Part-time use was for 4-6 hours a day, 7 days a week for a year. Clinical assessment included follow-up at 6 months and at 12 months upon allocation. The primary outcomes were a) change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction, and b) change in axial eye length (AL). The secondary outcomes were a) change in choroidal thickness (ChT), and b) assessment of the subjective tolerance.

Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 16 years old at the time of enrollment.
* Best-corrected visual acuity (BCVA) LogMAR 0.1 or better, in each eye.
* Cycloplegic Autorefraction: Myopia, SER between -0.50D and -6.00D, in each eye. Astigmatism less than or equal to 1.50D, in each eye. Anisometropia less than or equal to 1.50D between the two eyes.
* Absence of any ocular or systemic condition that could influence refractive development, other than myopia.
* Eagerness to participate in this study and receive myopia treatment in a randomized fashion. Availability for at least 1-year follow-up. Subject parent's or guardian's understanding of the protocol and acceptance to participate, providing a signed consent on behalf of the subject.

Exclusion Criteria:

* Presence of strabismus.
* Presence of amblyopia.
* Prematurity (gestational age less than 37 weeks).
* Presence of an ocular condition affecting refraction (ie. cataract, dislocated lens).
* Presence of a systemic condition affecting refraction (ie. Down syndrome, Marfan syndrome).
* Allergy to cyclopentolate. Severe ocular or systemic allergies.
TOPIC Trial for COPD

The study is a randomized, double-blind, placebo-controlled, multiple-dose, pilot study of orally-administered ivacaftor in subjects with chronic obstructive pulmonary disease. Subjects will be administered the study drug ivacaftor 150 mg (or placebo) twice daily (BID).


Eligibility Criteria:
Inclusion Criteria:

* Male or Female age 40-65
* A clinical diagnosis of COPD as defined by GOLD
* At Least a 10 pack year smoking history
* Exhibit symptoms of chronic bronchitis defined by MRC
* FEV1% predicted ≥ 35% and ≤70% Post Bronchodilator
* Clinically stable in the last 4 weeks with no evidence of COPD exacerbation
* Weight of 40 kg-120 kg
* Willingness to use at least one form of acceptable birth control including abstinence, condom with spermicide, or hormonal contraceptives
* Willing to monitor blood glucose if known history of diabetes mellitus requiring insulin or medical therapy

Exclusion Criteria:

* Current Diagnosis of Asthma
* Daytime use of Oxygen Therapy
* Documented history of drug abuse within the last year
* Subjects should not have a pulmonary exacerbation or changes in therapy for pulmonary disease within 28 days before receiving the first dose of study drug.
* Cirrhosis or elevated liver transaminases \> 3X ULN
* GFR \< 50 estimated by Cockcroft-Gault
* Any illness of abnormal lab finding that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug to the subject.
* Pregnant or Breastfeeding
* Subjects taking any inhibitors or inducers of CYP3A4, including certain herbal medications and grapefruit/grapefruit juice.
* Uncontrolled Diabetes
* Excluded medications and foods include the drugs and foods provided in the appendix document.
* Clinically significant arrhythmias or conduction abnormalities that in the opinion of the investigator affect patient safety have been added as exclusion criteria and criteria for withdrawal.

Patients who have not been stable or have been hospitalized in the past 3 months with any clinically significant cardiac conditions.

Subjects with history of cancer (current or past, unless remote (\>5years))except for localized non-melanomatous skin cancers History of Stroke/CVA History of myocardial infarction/acute coronary syndrome Cardiac Failure NYHC grade III-IV Diabetes Type I Uncontrolled Hypertension Primary or secondary pulmonary hypertension

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LBH589 in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma

The phase I study will evaluate the safety, efficacy and pharmacokinetics of LBH589B in adult patients with advanced solid tumors or Cutaneous T-cell lymphoma


Eligibility Criteria:
Inclusion Criteria:

* Patients with either a) histologically-confirmed, advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists, or b) cytopathologically confirmed cutaneous T-cell lymphoma (CTCL) whose disease has progressed despite standard therapy or for whom no standard therapy exists. Inclusion is irrespective of stage of disease or extent of prior therapy.
* World Health Organization (WHO) Performance Status of ≤ 2
* Patients must have the adequate laboratory values

Exclusion Criteria:

* Patients with a history of primary CNS tumors
* Patients with any history of brain metastases
* Patients with any peripheral neuropathy ≥ CTCAE grade 2
* Patients with unresolved diarrhea ≥ CTCAE grade 2
* Impairment of cardiac function
* Impairment of gastrointestinal (GI) function or GI disease
* Liver or renal disease

Other protocol-defined inclusion/exclusion criteria may apply
Early Gastric Decompression During Advanced Cardiopulmonary Resuscitation (EGD_ACLS)

This study aimed to identify the effect of early gastric decompression on the improvement of circulation in arrest patients during cardiopulmonary resuscitation at the clinical setting of emergency department.

Subjects and setting : adult sudden cardiac arrest patients in out of hospital, and transported to emergency department for advanced resuscitation treatment Interventions: first step, establish the advanced airway, after then insertion the naso (or oro)-gastric tube during CPR Data collection: live observation and review the automatically recoding data Missing or failed data should be collected and descriped Study period and sample size: numbers of participants necessary to identify the effect of interventions; 12 months or lesser were anticipated Analysis: All collected data can be analysed by Statistical programs

Eligibility Criteria:
Inclusion Criteria:

* Out of cardiac arrest patients who was transported to the emergency department for advanced resuscitation care

Exclusion Criteria:

* Do not attempted
* Inevitable death cofirmed at Emergency department
* Early recovery of spontaneous circulation before the intervention or sufficient collections of outcome data
* data loss
* others
Investigation of Endemic and Emerging Diseases in Populations of Homeless Households in Marseille.

Hypothesis:

Homeless people have infections not diagnosed with a potential impact on their health status.

Main Purpose: Improve the etiological diagnosis of endemic and/or emerging pathologies among homeless people.

In Marseilles, the population of homeless is estimated at 1500 individuals, including 800 usually sleeping in the street, 600 in foster homes and a hundred in the structures of care. The precarious living conditions of homeless persons promote the emergence or re-emergence of many communicable infectious diseases homeless people whose symptoms are often overlooked by the subject and rarely established etiologic diagnosis.

Among these diseases, frequently described in the literature are infestation by lice and infectious diseases that they transmit (Bartonella quintana), skin infections, hepatitis E and C and finally the infection with Tropheryma Whipplei. In this study we propose to systematically in homeless subject an etiological diagnosis of pathogens at the origin of these diseases (i) to improve knowledge (ii) to improve their management, (iii) to limit the contagion.

Eligibility Criteria:
Inclusion Criteria:

* Homeless Subject on the day of the study in one of two shelters for homeless Marseille ( Madrague City and Forbin )
* Major subject ( \> or equal to 18 years)
* Freely about having signed the written informed consent,
* About affiliated with a social security scheme

Exclusion Criteria:

* Minor Subjects ( \< 18 years )
* Major subject under guardianship (L. 1121-8 )
* Subject privated of freedom or under court order (L. 1121-6 )
* Subject refusing to sign the informed consent form ,
* Subject not affiliated with a social security insurance
* Pregnant women , parturient or nursing (L. 1121-7 ) .
Postmarketing Clinical Trial of tDCS to Evaluate Cognitive Ability in Depression Patients

This study is a multicenter, double-blind, randomized, and confirmed clinical trial in patients taking antidepressants during the 6-week stimulation period , sham stimulation group, low real stimulation group (1mA), high real stimulation group (2mA) and treatment every day for 6 weeks (a total of 42 times). As a primary outcome, the investigator analyze the improvement effect of working memory ability, and confirm whether the effects of anxiety and depression are improved by the secondary outcome, together with the quality of life evaluation.

During the clinical trial period, a total of 4 to 5 outpatient visits are made, and changes are evaluated through neuropsychological examination by visiting at 2, 4 and 6 weeks based on the baseline time point. In addition, in the case of patients who agree after 6 weeks of participation, an additional 6 weeks of high real stimulation is used to conduct an open extension study.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of major depressive disorder
2. CGI severity (severity of Illness) score of 3 or higher
3. Patients receiving medication for depression at the time of study participation
4. Those who can read and understand the subject's explanation and consent form and who can respond to questionnaires

Exclusion Criteria:

1. History of clinically significant medical neurological disease or history of head injury
2. In case of mental retardation or cognitive impairment enough to affect the writing of consent form or conducting research
3. Severe suicidal risk or psychotic symptoms determined by the clinician
4. In the case of a contraindication to the implementation of tDCS (when a metallic auxiliary tool is inserted in the head)
5. Those who are judged to have problems with the attachment of EEG and DC stimulation electrodes due to deformities, inflammatory reactions, or other dermatological problems at the electrode attachment site
6. Among female subjects who are likely to become pregnant, those who do not agree to contraception by a medically acceptable method for up to 24 weeks after application of the investigational medical device in this clinical trial
7. Pregnant women
8. Any other person who has reasons to judge that the investigator is unsuitable for participation in the clinical trial
Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism

The Objectives of this study is to determine the effect(s) of daily non-caloric artificial sweetener (NAS) consumption (sucralose or aspartame) on the composition of the bacteria and also to determine the changes in glucose metabolism.

The trial will be 12 weeks randomized, cross-over and double blinded with 2 treatment intervention ( sucralose and aspartame) , there will be a run in period (4 weeks), then phase 1 treatment period for two weeks followed by four weeks washout period then phase 2 treatment period(2 weeks). Healthy, normglycemic (\<5.6 mmol/L) males and females ( 17 total) of age 18-45 y with a body mass index (BMI) 20-25 kg/m2 will be recruited.

Each participants will be given the dose of sweetener aspartame or sucralose during the treatment phase in a double-blind procedure.

the participant will be asked to consume the sweetener in a mixed flavoured beverage during each visit in the treatment phase.

Blood and stool sample collection will take place before after the run-in period, and after the washout period, as well as after each two-week treatment period.

glucose measurement: Capillary blood will be collected during each visit by registered nurse. Blood will be collected at fasting and at 12,30,45,60,90 and 120 minutes after the participants drink a glucose drink (75g glucose) for Oral glucose tolerance test.

a food frequency questionnaire will be given to each participant in order to estimate how often each sweetener is consumed on a daily basis.

Participants will also be asked to complete weekly food diaries of food and drink consumption.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 20-25 kg/m2
* Fasting blood glucose (FBG) \< 5.7 mmol/L
* women with regular menstrual cycle.

Exclusion Criteria:

* probiotic or antibiotic use within 6 months prior to the start of the study
* metabolic or gastrointestinal disorders (diabetes mellitus types 1 and 2, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, phenylketonuria)
* pregnant or lactating women
Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer

This main purpose of this clinical study is to learn about the safety and activity of margetuximab and pembrolizumab combination treatment in patients with HER2+ gastric and gastroesophageal junction cancer.

Detailed Description: Both margetuximab and pembrolizumab are monoclonal antibodies used in combination to treat HER2+ gastric and gastroesophageal junction cancer. This study has two parts: Dose Escalation and Dose Expansion. The Dose Escalation phase of the study will evaluate safety of escalating doses of the combination treatment. The Dose Expansion phase will evaluate safety and activity of the combination in patients with gastric or gastroesophageal cancer once the final dose and schedule are defined. In addition, a cohort of patients with HER2+ 3+ gastric cancer patients will be enrolled in the Dose Expansion Phase.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent.
2. Age ≥ 18 years old (or minimum age based upon local regulations)
3. Unresectable locally advanced or metastatic histologically proven HER2+ gastroesophageal junction (GEJ) or gastric cancer. Gastric Cancer Expansion Phase will include only gastric cancer patients with 3+ HER2 positivity.
4. HER2+ as 3+ (as defined in AJCC staging manual 8th edition) by IHC or in-situ hybridation (ISH) amplified.
5. Have received prior treatment with trastuzumab.
6. Have received treatment with at least one or more lines of cytotoxic chemotherapy in the metastatic setting.
7. Resolution of chemotherapy, immunotherapy or radiation-related toxicities.
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
9. Life expectancy ≥ 12 weeks.
10. Measurable disease as per RECIST 1.1 criteria.

Exclusion Criteria:

1. Patients with symptomatic central nervous system (CNS) metastases.
2. Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment.
3. History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.
4. Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 3 weeks prior to the initiation of study drug.
5. Treatment with radiation therapy within 3 weeks prior to the initiation of study drug administration.
6. Treatment with corticosteroids (≥10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of study drug administration.
7. History of clinically-significant cardiovascular disease.
8. Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
9. History of (non-infectious) pneumonitis that required steroids or presence of active pneumonitis
10. Clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis.
11. Evidence of active viral, bacterial, or systemic fungal infection.
Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males

To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.

To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.

Eligibility Criteria:
Inclusion Criteria

1. Hypogonadal males
2. Screening testosterone \<300 ng/dL

Exclusion Criteria

1. Smokers
2. Previous history of or current or suspected prostate or breast cancer
Treatment With Pyrotinib-Based Therapy in Lapatinib Resistant HER2-Positive Metastatic Breast Cancer

This is a multicenter, observational, single-arm real world study to evaluate the efficacy and safety of pyrotinib after lapatinib progression.

HER2-positive breast cancers account for 15%-20% of all breast cancers. The development of HER2 targeted therapies have greatly improved the survival of HER2-positive breast cancer patients. Lapatinib has shown effectiveness in treating HER2-positive metastatic breast cancers, but therapies after lapatinib progression are still controversial. This study is aimed to evaluate the efficacy and safety of pyrotinib after lapatinib progression.

Eligibility Criteria:
Inclusion Criteria:

* Female and 18-70 years old
* Metastatic or locally recurrent HER2-positive breast cancer
* Patients received pyrotinib-based therapy after lapatinib failure in treatment for metastasis
* Complete and accurate medical data

Exclusion Criteria:

- Incomplete medical data