cyrilzakka/clinical-trials huggingface dataset:
AirSeal®Insufflation Trocar/CO2 Absorption Study

The purpose of this study is to compare carbon dioxide (CO2) absorption during gynecologic laparoscopy using the AirSeal® valveless trocar system versus standard insufflation trocars at intra-abdominal pressures of 10 and 15 mmHg.

The investigators hypothesize that with the AirSeal® valveless trocar system, gynecologic laparoscopy can be performed at a lower intra-abdominal pressure with a possible resultant decrease in CO2 absorption, while maintaining adequate visualization of the operative field for safe completion of surgery.

Three main factors affect patients' cardiopulmonary status during gynecologic laparoscopy: 1) degree of Trendelenburg tilt (25 - 30°), 2) carbon dioxide (CO2) absorption and 3) increased intra-abdominal pressure (10 -20 mmHg). Slight modifications to any or all of these three factors can lead to a significant decrease in morbidity.

The AirSeal® valveless trocar system reduces CO2 absorption when compared to standard trocars during renal laparoscopy. Also, use of this trocar system provides a more stable intra-abdominal pressure when compared to standard trocars, a feature that could possibly allow for laparoscopic surgery to be performed at lower intra-abdominal pressures.

Eligibility Criteria:
Inclusion Criteria:

* Any woman ≥ 18 years of age undergoing a gynecologic laparoscopic procedure
* Able to understand the consenting process and willing to participate in study

Exclusion Criteria:

* Patient unable to undergo laparoscopic procedure due to size of pathology or medical comorbidities
* Emergent surgery
Drug Use Investigation for Cell-culture Derived Influenza A (H1N1) Emulsion HA Vaccine

This is to evaluate safety of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Japanese

Exclusion Criteria:

1. The person has received any other company's new influenza vaccine (swine-derived A/H1N1) before vaccination with this product.
2. The person has participated in any clinical study of this product or any other company's new influenza vaccine (swine-derived A/H1N1) and received the investigational vaccine.

   The person is regarded as a subject in one of the following items 3) to 6) who is not appropriate to receive preventive vaccination as described in the current package insert.
3. The person shows obvious fever.
4. The person obviously suffers from serious acute disease.
5. The person has obviously shown anaphylaxis due to an ingredient of this vaccine.
6. The person is otherwise in an inappropriate state to receive preventive vaccination.
Effects of Hydrogen Gas Inhalation on Adults of Various Ages

Herein, investigated the effects of 4 weeks of H2 gas inhalation on community-dwelling adults of various ages.

Molecular hydrogen (H2) is a versatile therapeutic agent. H2 gas inhalation is reportedly safe and has a positive impact on a range of illnesses, including Alzheimer's disease (AD). Herein, investigated the effects of 4 weeks of H2 gas inhalation on community-dwelling adults of various ages. Fifty-four participants including those dropped out (5%) were screened and enrolled. The selected participants were treated as a single group without randomization. Evaluated the association between total and differential white blood cell (WBC) counts and AD risk at individual levels after 4 weeks of H2 gas inhalation treatment. Furthermore, evaluation of dementia-related biomarkers such as beta-site APP cleaving enzyme 1 (BACE-1), amyloid beta (Aβ), brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor A (VEGF-A), T-tau, monocyte chemotactic protein-1 (MCP-1), and inflammatory cytokines (interleukin-6).

Eligibility Criteria:
Inclusion

* Age ranges 40-70 years
* Healthy participants
* Patients who are willing or able to follow the doctor's instructions
* Fully understand the purpose and procedure of this clinical trial

Exclusion Criteria

* Participants excluded those who have any disease
* Pregnant and lactating women
Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

Study Rationale: an accurate breast cancer staging has a great impact in the management of a breast cancer. MRI is considered as the most sensible exam for this staging. However it has a low specificity and it may result in extra testing and stress for the patient, add to costs, and delay treatment. By contrast, Tomosynthesis is performed during the same time than mammography and has a good specificity. Although this modality is very promising, it has not been assessed in a population of consecutive patients.

Study objectives: To compare the diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.


Eligibility Criteria:
Inclusion Criteria:

* Women at least 40 years old
* Subject with a new lesion recommended for biopsy, whatever the modality which detected the lesion (clinical examination, mammography, tomosynthesis, US, or MRI)

Exclusion Criteria:

* Subjects with BRCA mutation or at high genetic risk
* Subjects who have breast implants
* Personal history of breast cancer
* Subjects who are pregnant or who think they may be pregnant
* Subjects who are breast-feeding
* Subjects who are unable or unwilling to tolerate study constraints
* Subjects unable or unwilling to undergo informed consent
* Subject with no rights from the national health insurance programme
A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors

This research study aims to explore the feasibility and acceptability of an adapted resiliency group program, called the Relaxation Response Resiliency Program (3RP-AYA), to reduce stress and promote stress-management among adolescents and young adults who have completed treatment for cancer.

The Relaxation Response Resiliency Program, or 3RP, was developed by researchers at the MGH Benson-Henry Institute for Mind Body Medicine. The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being.

The 3RP has not yet been carried out with adolescent or young adult individuals who have recently completed treatment for cancer. As such, the investigators have adapted the original 3RP to target the specific needs of adolescent and young adult patients who are transitioning off active treatment. The investigators are conducting this study to see if the adapted program, the 3RP-AYA, is effective at reducing stress and stress-related symptoms for people of at least age 16 who have completed treatment for cancer within the past five years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with any cancer between ages 14 and 29
* Completed cancer treatment within the past 5 years
* At least 16 years of age at time of enrollment

Exclusion Criteria:

* Unwilling or unable to participate in the study
* Unable to speak or read English
* Is medically or otherwise unable to participate (as determined by a physician or study PI)
* Unwilling or unable to participate in study sessions delivered via the Partners Telehealth videoconferencing software
* Participation in a focus group during Phase 1 (DF/HCC 17-315)
A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza

The purpose of the study is to determine whether Appethyl™, made from spinach, will reduce appetite and hunger given on the same day of testing.

Four hours after breakfast a small amount of liquid to drink will be given to a participant that will contain either the Appethyl™ or placebo. Participants will be given a lunch of about 750 calories and 40% fat prepared by the Metabolic Kitchen and be asked to eat all of it. Participants will have food choice testing performed 4 hours after starting their lunch meal. This will be done in two ways. Participants will be given a list of two foods that are made of carbohydrate like bread and pretzels and be asked which is most preferred. Participants will also be given a list of foods that differ in the amounts of fat, carbohydrate and protein that they contain and will be asked to mark the ones that appeal to them.

Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.

Eligibility Criteria:
Inclusion Criteria:

* You are a male or female aged 18 to 65 years.
* You have a BMI (a number calculated from your height and weight) between 25-35 kg/m2, inclusive.
* Your waist circumference is over 35 inches.

Exclusion Criteria:

* You have been on a diet for weight loss in the last 2 months.
* You are being treated for blood pressure, diabetes, heart disease, rheumatoid arthritis, or blood vessel disease.
* You have a psychotic illness.
* You have other chronic diseases like an inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
* You have a dysfunction of your gastrointestinal tract.
* You have food allergies.
* You have rheumatoid arthritis with inflammation.
* You have chronic constipation.
* You are taking any products to lose weight such as medication for obesity or non-prescription medications for weight loss.
Key to Improve DiagNosis in Aspiration Pneumonia

To evaluate the diagnostic performance of amylase assay performed from bronchial alveolar fluid to differentiate aseptic chemical inhalation pneumonitis from an infectious inhalation pneumonitis in comatose patients with intubated ventilation for less than 24 hours.

Validation of the potential diagnostic performance of amylase assay compared to gold standard in diagnosis of infectious inhalation pneumonia of the comatose patient enabling the realization of a multicentric study using this innovative method in a diagnostic strategy with the objective of reducing the consumption of antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Patient intubated ≤ 24 hours for unconsciousness (stroke, meningitis, drug intoxication, metabolic disorders, epilepticus, cardiac arrest).
* Inhalation table with hypoxemic acute respiratory insufficiency post-consciousness + chest x-ray revealing one or more compatible infiltrates + t °\> 38 ° C).
* Age ≥18 years
* Patient affiliated to the social security system.
* No opposition obtained

Exclusion Criteria:

* Immunocompromised patient.
* Cardiorespiratory arrest requiring therapeutic hypothermia.
* Pneumopathy nosocomiale (pneumopathy beginning\> 48h after hospital admission).
* Infectious Pneumonia in the previous 30 days.
* Previous hospitalization in the previous 30 days.
* Patient under antibiotic at baseline.
* Bacteremia.
* Mechanical ventilation begun before unconsciousness.
* Report Pa02 / FI02 \<80.
* Patient under curatorship and / or guardianship.
Cenobamate Expanded Access Program (EAP)

This Cenobamate Expanded Access Program (EAP) is designed to continue providing treatment with Cenobamate (YKP3089) to patients with partial-onset epilepsy that were enrolled in the SK Life Science clinical trial YKP3089C013, YKP3089C017 or YKP3089C021.

This Expanded Access Program (EAP) is designed to provide access to an unlicensed drug that is approved in the United States for the treatment of a serious or life-threatening condition. This EAP will be sponsored by SK Life Science Inc. and managed by WEP Clinical. Cenobamate is approved for the treatment of partial onset seizures in adults in United States. The attached US Label (appendix 1) provides the most recent guidance for use of cenobamate.

The objective of this EAP is to continue providing treatment with Cenobamate (YKP3089) to patients with partial-onset epilepsy that were enrolled in the SK Life Science clinical trial YKP3089C013, YKP3089C017 or YKP3089C021. Access to Cenobamate under this guideline is considered a treatment scenario and is not a clinical trial.

Epilepsy is a symptom of a neurological problem that causes sudden, brief seizures. It leads to an increased risk of injury from accidents, an increased rate of mortality, and has a significant impact on quality of life. Epilepsy can occur as a result of a neurological injury, a structural brain lesion, as a part of many systemic medical diseases or may be generic in origin. The incidence of having epilepsy during a lifetime is between 2-5%. Available medications control seizures in 50% of patients and decrease seizure incidence in 75%. The remainder continued to have unacceptable number of seizures, side effects, and psychiatric symptoms. The high treatment failure may be the result of inadequate efficacy or intolerable side effects that lead to poor compliance.

Cenobamate is a novel small molecule that is an antiepileptic agent for partial onset seizures. The precise mechanism by which cenobamate exerts its therapeutic effects in patients with partial-onset seizures is unknown. Cenobamate has been demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel.

Eligibility Criteria:
INCLUSION CRITERIA

1. Patients currently enrolled in one of the following SK life science studies: YKP3089C013, YKP3089C017 or YKP3089C021.
2. Patient who is currently pregnant and enrolled in one of the following SK life science studies: YKP3089C013, YKP3089C017 or YKP3089C021 may enter the EAP program.
3. Written informed consent signed by the patient or legal guardian prior to entering the EAP in accordance with the ICH GCP guidelines. If the written informed consent is provided by the legal guardian because the patient is unable to do so, a written or verbal consent from the patient must also be obtained.

EXCLUSION CRITERIA

1. Patients that have previously discontinued for any reason from studies YKP3089C013, YKP3089C017 and YKP3089C021.
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in the United Kingdom, as Part of Local Clinical Practice

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor. Participants will be asked to complete some questionnaires about their diabetes treatment. Participants will complete these during their normally scheduled visits with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* Diagnosed with type 2 diabetes mellitus
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Available glycated haemoglobin (HbA1c) value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (Visit 1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (Visit 1) if in line with local clinical practice
* Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of 14 days or less.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Treatment with any investigational drug within 30 days prior to enrolment into the study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy Subjects

This is a randomized, double-blind, placebo controlled, single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects.

This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects, who have no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations.
* Body Mass Index (BMI) of 18.5-30 kg/m\^2, inclusive. BMI=weight (kg)/\[height(m)\]\^2.
* Males and Females, not of child-bearing potential, ages 21 to 65 years, inclusive. Female subjects must have documented proof that they are not of childbearing potential.
* Male subjects must be willing to use effective birth control and refrain from sperm donation during the entire study and for 200 days after dosing has been completed.

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding.
* Any significant acute or chronic medical illness.
* Any history of cancer within 5 years of enrollment.
* Any major surgery within 4 weeks of study drug administration.
* Donation of blood or serum \> 500 mL to a blood bank or in a clinical study (except screening visit) within 3 months of study drug administration.
* Participation in a clinical study (except a screening visit) within 4 weeks (or 5 half lives, whichever is longer), of study drug administration.
* Inability to be venipunctured and/or tolerate venous access.
* Has smoked or used tobacco products within 6 months prior to study drug administration.
* Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse
Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine

The objective of this study is to evaluate the relevance of Porphyromonas as a biomarker predicting the risk of P. aeruginosa primocolonization in children form 0 to 18 years old with cystic fibrosis.

This is a monocentric study in 3 phases:

* Pre-inclusion: at the first visit to the CRCM (support for a positive screening confirmed by sweat test and genotyping CFTR)
* Inclusion: possible between the 2nd visit to the CRCM (about 2 months old) and the 6th month
* Follow-up: up to 36 months old. The pace of visits will be based on the usual follow-up rate of CF infants Clinical and paraclinical data and samples will be collected as part of the usual follow-up of CF children. Inclusions and follow-up visits will be carried out at the Roscoff CRCM as well as respiratory explorations and biological samples. Dermatological and odontological follow-ups will be scheduled for each patient at the rate of an annual visit to the CHRU in Brest in the relevant departments.

Eligibility Criteria:
Inclusion Criteria:

* Newly screened infants with a confirmed diagnosis of cystic fibrosis in its classic form (clinical symptoms and two positive sweat tests and/or two mutations of the cftr gene from Class I to III)
* Children free of any colonization with P. aeruginosa
* Affiliation with the social security system
* Consent signed by the holders of parental authority or the sole parent holding parental authority

Exclusion Criteria:

* Children colonized with P. aeruginosa according to the cytobacteriological examination and / or molecular test of sputum or pharyngeal specimens
* Children grafted
* Children not affiliated to a social security scheme or not entitled to
* Children whose parent (s) are (are) minor (s)
* Children whose holders of parental authority do not master the French language
* Refusal to participate in the study
Tear Film Evaluation After Phacoemulsification

To compare tear film differences between surgical eyes and nonsurgical eyes in patients who had cataract surgery by phacoemulsification in one eye.

All participants granted their written informed consent to participate in the research protocol.

Eligibility Criteria:
Inclusion Criteria:

age-related cataract without surgery history and dry eye symptoms history

Exclusion Criteria:

diseases influencing tear secretion (such as Sjögren syndrome, Steve-Johnson syndrome, diabetes, thyroid disease, etc.); history of ocular surgeries or nuclear hardness IV and V, which required the use of larger phacoemulsification energy; use of drugs that affect tear secretion and stability (such as glaucoma medications, artificial tears, corticosteroid drugs, etc.); or presence of ocular diseases (such as Pterygium, blepharitis, uveitis, glaucoma, lacrimal apparatus, etc.).
Treatment of Unstable 31.A2 and 31.A3 Trochanteric Fractures. Randomised Comparison of the Proximal Femoral Nail PFN-A Short and the PFN-A Long.

1. Introduction:

   Controversy exists with regard to whether to treat AO/OTA (Orthopaedic Trauma Association) 32.A2 - 32-A3 fractures of the proximal part of the femur with an intramedullary short PFN-A or long PFN-A. A prospective, randomized, controlled trial is performed to compare the outcome treatment of these unstable fractures of the proximal part of the femur with either a short PFN-A (170-240mm) or long PFN-A (300-420mm).
2. Objectives and Hypothesis The hypothesis is that the Short PFN-A would have fewer complications than Long PFN-A

   Main Objective: Is defined as Total number of complications between PFN-A short and PFN-A long. Outcome measures were subdivided into preoperative, perioperative and post-operative. Follow up data at four weeks, three months and one year.

   Secondary objectives: Complete and uneventful radiological and clinical healing of the fracture. Revision operations (related to the failure of primary treatment) and mortality. Baseline characteristics were documented pre-operatively: Outcome measures were subdivided into intra-operative, post-operative and follow up data at four weeks, three months and one year.
3. Methodology: One hundred and eighty eight patients presenting with an AO/OTA 31-A2 and 31-A3 fracture of the proximal part of the femur will be randomized, at the time of the admission, to fixation with use either a short PFN-A or a long PFN-A.


Eligibility Criteria:
Inclusion Criteria:

* Patients 60 years old above.
* Patients with trochanteric fracture 31.A2 and 31.A3 AO classification for long bones
* Patients that accept to participate on the study under consent

Exclusion Criteria:

* Metaphyseal fractures with extension more than 3 cm in reference to lesser trochanter calibrated and analyzed with PreOPlan registered application.
* Combination of fractures in the proximal femur.
* Pathological fractures.
* Diaphyseal femoral fractures.
* Rejection of surgery by the patient.
* Contraindications to the use of either implants studied.
* Patients who do not wish to participate in this study