cyrilzakka/clinical-trials huggingface dataset:
The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)

To assess the impact of the female genital microbiome on ART outcome.

The main objective of this study is to learn more about which microbial spectra are negatively or positively impacting IVF pregnancy outcome. This information is needed before proceeding to the next step in which an adaptation of the microbiome can be attempted to improve IVF outcome. The study is expected to shed light over the possible influence of the microbiome on causes for subfertility, endometrial receptivity and obstetrical complications. A diagnostic link may be found with entities that are often unexplained today, e.g. (recurrent) miscarriage and repeated implantation failure.

Eligibility Criteria:
Inclusion Criteria:

1. Caucasian women
2. Women undergoing an in-vitro fertilization cycle (for the first or second time)
3. Single embryo transfer
4. Day 5 embryo transfer
5. Gonadotropin-releasing hormone antagonist
6. Anti-mullerian hormone \> 0,69 and \< 3,5 µg/L
7. Body mass index ≤ 30 kg/m2
8. Signed informed consent

Exclusion Criteria:

1. Women suffering of chronic diseases which may impair pregnancy outcome (e.g. diabetes, chronic renal disease).
2. Antibiotics within 3 weeks of sampling
3. Surgical sperm retrieval
4. In-vitro maturation
5. Preimplantation genetic diagnosis
6. Grade 3 or 4 endometriosis
7. Patients unable to comprehend the investigational nature of the proposed study
Defining Volume Status with Extracellular Water Measurement in Patients with Intracranial Hemorrhage

The goal of this observational study is to learn about the influence of extracellular water on volume status in adult patients with intracranial hemorrhage presenting with hemodynamic instability. The main question it aims to answer is:

• Can measurement of extracellular water contribute to the description of hemodynamic instability in adult patients with intracranial hemorrhage. Patients with intracranial hemorrhage admitted to intensive care will receive standard care with the addition of measurement of extracellular water.

Adult patients with intracranial hemorrhage admitted to ICU will be recruited. During the first five days after inclusion blood samples and extended non-invasive monitoring, including monitoring of the microcirculation (CytoCam) and measurement of extracellular water (dielectronic constant), will be added to routine care and monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Adults with intracranial hemorrhage admitted to ICU.

Exclusion Criteria:

* Pregnancy, palliative care.
Registry Study for Talimogene Laherparepvec

A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials

A registry study is to evaluate the overall survival, use of subsequent anti-cancer therapy, and the long-term safety of subjects who have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type. Follow-Up will occur every 3 months.

Eligibility Criteria:
Inclusion Criteria:

All subjects must provide informed consent prior to initiation of any study activities.

All subjects must have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type and must have discontinued treatment and participation, including long-term follow-up (if applicable) in that trial.

Exclusion Criteria:

Subjects currently receiving talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial.

Subject currently participating, including for long-term follow-up (if applicable), in other Amgen-sponsored talimogene laherparepvec clinical trial.
Laparoscopic Segmental Bowel Resection for Deep Infiltrating Colorectal Endometriosis

This study is executed to evaluate the outcome on quality of life, pain, sexuality, pregnancy rate and recurrence rate after a fertility sparing multidisciplinary CO2 laser laparoscopic radical excision of deep infiltrating colorectal endometriosis with a bowel resection.

Patients

All women (n=45) who had undergone fertility sparing CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with bowel resection were selected retrospectively from the list of all patients (n=more than 500, of whom slightly more than 50% with endometriosis) operated at the Leuven University Fertility Centre (LUFc) between September 2004 and September 2006.

Questionnaires

All 45 patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire (27), a sexual activity questionnaire (28), visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, and to answer questions about medication and fertility, to compare their status before surgery and at the moment of the evaluation (December 2008).

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from deep infiltrating endometriosis with colorectal extension
* Who had undergone CO2 laser laparoscopic radical excision of the endometriosis
* with bowel resection performed by the colorectal surgeon
* between September 2004 and July 2006.

Exclusion Criteria:

* Patients without bowel resection
Normal Values for Esophageal High Resolution Manometry in an Advanced Protocol Including Liquid Swallows and a Solid Test Meal

Normal values for measurements of high resolution manometry in a protocol which includes isolated liquid swallows in upright and recumbent position, free drinking of water, a solid test meal and a postprandial observational period will be determined.

The investigators will recruit healthy volunteers and ask for study participation. After providing informed consent, participants will be questioned using standardized questionnaires assessing symptoms of reflux, dysphagia, gastrointestinal symptom burden and depression. Participants will be tested using our advanced protocol for high resolution esophageal manometry. This protocol includes individual liquid swallows, free drinking of water, a standardized test meal (200g rice) and a postprandial observational period. Normal values for liquid and solid swallows will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers without gastrointestinal co-morbidity

Exclusion Criteria:

* Inability or unwillingness to provide informed consent
* Any relevant current or past gastrointestinal morbidity (including diseases relevant previous surgery).
* Relevant gastrointestinal symptoms
* Relevant medication (as specified below) within the last 4 weeks
* Age below 18 years
Fluoroscopy Guided Femoral Arterial Access

The purpose of this study is to compare the use of fluoroscopic guidance, (a commonly used X-ray technique), with the traditional approach, (where the doctors feel for the strongest pulse), to obtain access to the blood vessel in the groin. These two methods are being compared to assess which is faster, safer and more often allows your physician to use an "arterial closure device," a small suture or plug applied at the end of the angiogram where the needle enters your blood vessel if he/she chooses.

Design: A prospective, randomized, controlled clinical trial to study the effectiveness of applying fluoroscopy guided femoral artery access in the cardiac catheterization lab and its effect on the usage of FDA approved femoral artery closure devices. This trial will randomize patients between fluoroscopy guided femoral artery access or femoral artery access using the usual anatomic landmarks and will then study the difference in the ability to use closure devices on the access site.

Purpose: To establish the safety and efficacy of using fluoroscopic assistance to allow access of the common femoral artery rather than its branches and thus increase the ability to use closure devices.

Enrollment: An approximate enrollment of up to 1000 patients (all patients randomized) who will be undergoing cardiac catheterization and who meet all the eligibility criteria at OUMC and VAMC in Oklahoma City.

Duration: The study will be conducted over approximately one year.

Primary Endpoint: Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm.

Secondary Endpoints:

1. Compare the incidence of known major side effects of femoral artery puncture between the two methods of access
2. Compare the time and number of attempts needed to obtain arterial access between the two groups of patients.
3. Compare the ability to puncture the common femoral artery using fluoroscopy vs. anatomical landmarks among different levels of trainees (cardiology fellows) and attending cardiologists.
4. Assess whether fluoroscopic guidance is a superior method to obtain access and thus should be used as a training technique for cardiology fellows.

Analytical Subset: Intention-to-treat sample

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over.
* Patients undergoing elective or urgent left heart cath from the femoral approach.
* Willingness to participate and sign the consent form.

Exclusion Criteria:

* Access from site other than the common femoral artery.
* Creatinine \>= 3.0mg/dl.
* Graft in the common femoral artery or other surgeries at that site that might have changed the anatomy of the groin.
* Unable or refusal to sign a consent form.
* Patients from the Department of Corrections.
* Pregnant Women
* Undetectable femoral artery pulse.
* Patients undergoing emergent cardiac catheterization for ST elevation MI or unstable ACS.
Me & My Wishes: An Efficacy Trial Using Videos

The aim of this study is to determine whether the Me \& My Wishes intervention positively impacts communication of preferences among nursing home residents with dementia and their family caregivers and care team.

Me \& My Wishes are videos of nursing home residents talking about their preferences for care, including four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Knowing what residents want is essential to staff's ability to provide quality care and can inform family caregivers decision making especially in later stages of life as the resident's cognition declines-a time when family caregivers often feel unprepared. Persons with mild to moderate dementia can accurately express their everyday and EOL preferences, however, stereotypes persist about the decision making abilities of people with dementia that often prevent their involvement in conversations about care. The investigators propose to conduct a Stage II efficacy trial of Me \& My Wishes-a novel approach for communicating resident care preferences-by creating videos with 48-54 nursing home residents with mild to moderate dementia and sharing their personalized video with informal (family) and formal (staff) caregivers. The investigators will employ a randomized wait-list control design in which residents in control nursing homes will delay sharing their video. Videos may be viewed two ways: 1) in resident quarterly care conferences; and 2) via a web-based link with resident-identified family members or friends.

Eligibility Criteria:
Resident Inclusion Criteria:

* Identified as having Alzheimer's or related dementia
* Mild to moderate cognitive impairment (BIMS = 8-15, (MDS C0500) (nursing home residents only)
* Makes Self Understood = \<1 (MDS B0700)/present in medical record
* Understood By Others = \<1 (MDS B0800)/present in medical record
* Reside at the facility at least 2 weeks identified as a long-term resident
* Age \>65 years
* Speaks English

Family Inclusion Criteria:

* Speaks English
* Willing and able to watch the videos
* Willing to complete short surveys. Being unable to attend care conference to view the video (e.g. due to distance) will not exclude family from participating.

Staff Inclusion Criteria:

* Speaks English
* Willing to watch the videos
* Willing to complete short surveys

Resident Exclusion Criteria:

* Limited communication capacity (e.g. aphasia)
* Comatose
* Cognitively intact
* Severe cognitive impairment
A Human In Vivo Feeding Study Of The Blood Monocyte Response To Dietary Lipid Intake

The aim of the present study is to identify the effects of different dietary fats on the body's immune system and how different types of cells respond. There will be two rounds of recruitment in order to satisfy different aims of the study. In the first round, volunteers will be asked to undergo five separate 1-day assessments where you will be given diets in the form of milkshakes differing in amounts of fats. Volunteers recruited for this round will also be given the opportunity to participate in the second round of recruitment and feeding. A second round of recruitment will then take place to complete recruitment, if required. In the second round, volunteers will be asked to undergo two separate 1-day assessments in the form of milkshakes with differing fats, one of which will contain a tracking label added to the food during preparation. This label is in the form of is a 'stable isotope' and safe to consume (used commonly in some medical tests - see below for further information) and will allow the researchers to later find the food particles within blood cells. During these 1-day assessments blood samples will be collected to identify the impact different diets have on the immune system, specifically monocyte cells thought to play an important role in the development of atherosclerosis, a primary cause of cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* healthy men
* aged between 18-65 years (inclusive)
* body mass index of between 18.5-25kg/m2

Exclusion Criteria:

* Female
* Undiagnosed metabolic syndrome (assessed at initial screening)
* Current smokers
* Substance abuse
* Excess alcohol intake
* Significant medical illness including: diabetes, established cardiovascular disease, cancer, gastrointestinal disease (e.g. inflammatory bowel disease or irritable bowel syndrome), kidney, liver or pancreatic disease or autoimmune or inflammatory disease processes.
* Taking regular medications
* Major surgery in last 6 months
Survey of Incidence of Respiratory Tract Infections

The purpose of this study is to acquire reliable and current data on the actual incidence (post-COVID) of respiratory tract infections in the general adult population in the absence of any intervention. These data will provide useful background information for designing future studies aimed at assessing whether preventive measures or pharmacological treatments are beneficial in reducing the frequency and severity of infectious episodes.

This multicentric prospective observational survey will be carried out in Italy during the winter and early spring ( December 22nd to April 30th) in two consecutive years on approximately 2750 subjects recruited in the period between November 1st and December 21st in different medical settings and regions.

Investigators from 4 different institutions will be involved:

FIMMG (Federazione Italiana dei Medici di Medicina Generale). Ten general practitioners will recruit approx. 1000 consecutive subjects from the general population.

SIAAIC (Societa' Italiana di Allergologia, Asma e Immunologia Clkinica). Ten allergy specialists will recruit approx.1000 consecutive subjects suffering from allergic diseases.

Fondazione Maugeri (5 Centers) and UCSC (Universita' Cattolica del Sacro Cuore) / Policlinico Gemelli will recruit approx. 750 consecutive subjects suffering from asthma or COPD.

Participants having signed an informed consent at any suspected Respiratory Tract Infection (RTI) during the observation period will be asked to contact (phone call or visit) the investigator to record the relevant clinical information documenting the RTI episode.

At the end of the observation period all subjects will be contacted by the investigators to check for completeness and compliance of the RTI reporting.

The procedure will be repeated in the same way in the second year of survey but including subjects having experienced at least one confirmed RTI during the first year. This will allow assessing intra-individual variability of infectious episodes from year to year.

Eligibility Criteria:
Inclusion Criteria:

Male or female aged from at least 18 years -

Exclusion Criteria:

Minor subjects-
Coordinating Pragmatic Primary Care Population Management for Obesity

The C3PO pilot and feasibility study uses a rigorous, mixed-method research design to provide information needed to refine and implement a technology-mediated primary care outreach intervention approach before conducting a larger and more definitive future intervention trial.

This study will implement and evaluate a pragmatic and generalizable framework for population management of obesity by the primary care sector. With patient and other stakeholder input, the C3PO intervention will be designed to leverage existing primary care professionals and technologies to implement a scalable framework for population obesity management that coordinates primary care services with extant intensive lifestyle interventions in community settings to achieve wider reach and population-level effectiveness. A rigorous, mixed-method pilot and feasibility study will provide critical information needed to optimize the intervention design and prepare us for a larger and definitive future trial.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 27 kg/m2
* ≥ 1 CVD risk condition (hypertension, dyslipidemia, prediabetes or type 2 diabetes)
* Registered in Northwestern Medical Group's EpicCare MyChart patient portal
* Received and completed MyChart survey of weight loss interest
* Affirms interest in weight loss goal setting and receiving additional resource information and electronic Scale.

Exclusion Criteria:

* Evidence of hospitalization in past 30 days
* Most recent blood pressure \>180/105
* Cancer (non-skin) treatment within the past 2 years
* Encounter diagnosis for hypoglycemia in past 30 days
* Actively receiving care from the bariatric surgery service or a bariatric medication order in the past 100 days
Efficacy and Mechanisms of Acupuncture for Patients With Advanced Pancreatic Cancer Pain

This study compares the effect of acupuncture and placebo acupuncture on advanced pancreatic cancer pain and then investigates its potential mechanism of peripheral blood.

Acupuncture may alleviate abdominal or back pain of patients with advanced pancreatic cancer. Acupuncture participants would receive electroacupuncture on Jiaji (Ex-B2) points for 3 times in a week. Placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period. Pain scores on numeric rating scale (NRS) and blood levels of β-endorphin and nerve growth factor are compared.

Eligibility Criteria:
Inclusion Criteria:

* Advanced pancreatic cancer at Ⅲ-Ⅳ stage diagnosed by histological/cytological examination.
* Pain score of abdominal or back pain ≥3 on a numeric rating scale (NRS) graduated from 0 to 10.
* Stable dose of analgesics at least 72 hours before randomization.
* Expected survival time more than 1 month.

Exclusion Criteria:

* Another cause for abdominal or back pain (such as prolapse of lumbar intervertebral disc, ulcer or other intra-abdominal disorder).
* Acupuncture treatment in the past.
* Contraindications for the use of acupuncture (such as severe allergies, bleeding tendency, infectious dermatosis and ulcer or scar at points).
* Unable to give informed consent.
Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib

The purpose of the study is to determine the absorption, metabolism, and excretion of \[14C\]-evobrutinib in healthy participants


Eligibility Criteria:
Inclusion Criteria:

* Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
* Have a body weight within 50.0 to 120.0 kilogram (kg) (inclusive) and body mass index within the range 19.0 - 30.0 kilogram per meter square (kg/m\^2) (inclusive)
* Male participants agree to be consistent with local regulations on contraception methods
* Can give signed informed consent
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
* Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery
* Any surgical or medical condition which might significantly alter the ADME of drugs
* History of any malignancy, chronic or recurrent acute infection
* History of shingles
* History of drug hypersensitivity ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients
* History of alcoholism or drug abuse
* History of residential exposure to tuberculosis, or a positive QuantiFERON test at screening
* Administration of live vaccines or live-attenuated virus vaccines
* Any condition, including findings in the laboratory tests, medical history, or other screening assessments, that in the opinion of the Investigator constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study's objectives, conduct, or evaluation
* Prior/concomitant therapy
* Relevant radiation exposure
* Clinically relevant findings (excluding minor deviations) in biochemistry, hematology, coagulation and urinalysis
* Vital signs (pulse rate and blood pressure) outside the normal range
* Estimated Glomerular Filtration rate according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
* Semi supine systolic blood pressure (SBP) greater than (\>) 140 millimeters of Mercury (mmHg) or less than (\<) 90 mmHg, diastolic blood pressure (DBP) \> 90 mmHg or \< 45 mmHg and pulse rate \>= 100 bpm or =\< 40 bpm, at admission
* 12-Lead electrocardiogram (ECG) showing a QTcF \> 450 millisecond (ms), PR \> 215 ms, or QRS \> 120 ms
* Positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV) I and II tests at screening
* Other protocol defined exclusion criteria could apply