cyrilzakka/clinical-trials huggingface dataset:
Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy

The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal). We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.

This study is designed to determine the clinical utility of intravenous indocyanine green (ICG) injection pre-operatively for cholecystectomy, followed by visualizuation of the biliary tree with a near-infrared light source and camera. Testing will be done during an abdominal surgery which requires gallbladder removal. Subjects will be recruited during consult for their surgical procedure. The study itself will take an estimated 5 minutes during the procedure. 2.5mg of ICG will be injected intravenously 60-30 minutes before surgery, and following perfusion of the biliary tree, images will be recorded and visibility of the appropriate anatomy will be assessed using a near-infrared light source and camera. If fluorescence has faded prior to adequate visualization, a repeat dose of 2.5mg IV ICG may be given. Following the completion of imaging, the standard procedure for cholecystectomy will be performed including intraoperative cholangiography (IOC), which is standard of care. Subject post-operative recovery will be monitored for the duration of their hospital stay. Adverse events will be monitored at the patient's routine follow up visit.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-89
* Planned laparoscopic cholecystectomy

Exclusion Criteria:

* Inability to provide informed consent
* Pregnant
* Allergy to ICG, iodine, and/or shellfish
* Acute cholecystitis, cholangitis, and/or cirrhosis (main study)
* Lactating
Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing Therapy Regimen

Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients with HIV type 1 infection

Exclusion Criteria:

* Counter-indications according to summary of product characteristics (SPC) for Viramune tablets
* No persons under 18
* Pregnancy and breast-feeding
* Use of oral contraceptives
* Use of drugs affecting CYP450 3A metabolism
Acute Sleep Deprivation on Whole-body Heat Exchange During Exercise-heat Stress in Young and Older Men

Sleep deprivation has long been thought to modulate thermoregulatory function. Seminal work on sleep deprivation and thermoregulation has demonstrated that sleep-deprived individuals experience greater elevations in core temperature during exercise-heat stress due to reductions in the activation of local heat loss responses of cutaneous vasodilation and sweating. However, it remains unclear 1) if reductions in local heat loss responses would compromise whole-body heat loss (evaporative + dry heat exchange) and 2) if differences exist, are they dependent on the heat load generated by exercise (increases in metabolic rate augments the rate that heat must be dissipated by the body). Further, much of the understanding of the effects of sleep deprivation on thermoregulation has been limited to assessments in young adults. Studies show that aging is associated with reduction in cutaneous vasodilation and sweating that compromise whole-body heat loss exacerbating body heat storage during moderate- and especially more vigorous-intensity exercise in the heat. However, it remains unclear if sleep deprivation may worsen this response in older adults.

The purpose of this study is therefore to evaluate the effects of sleep-deprivation on whole-body total heat loss during light, moderate, and vigorous exercise-heat stress and to assess if aging may mediate this response. To achieve this objective, direct calorimetry will be employed to measure whole-body total heat loss in young (18-30 years) and older (50-65 years) men during exercise at increasing, fixed rates of metabolic heat production of 150 (light), 200 (moderate), and 250 W/m2 (vigorous) in dry heat (40°C, \~15% relative humidity) with and without 24 hours of sleep deprivation.


Eligibility Criteria:
Inclusion Criteria:

* healthy young (18-30 years) and older males (50-65 years)
* non-smoking
* English or French speaking
* ability to provide informed consent

Exclusion Criteria:

* presence of chronic diseases (e.g., hypertension, diabetes)
* acute illness (e.g., flu, COVID-19)
* physical restriction limiting physical activity (e.g., severe arthritis, etc.)
* use of medication judged by the patient or investigators to make participation in this study inadvisable
* engaged in regular endurance training
Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke

Fundoscopy, optical coherence tomography (OCT) and OCT-angiography (OCTA) are established examinations and bear minimal risks. The recognition of retinal microvascular signs will enhance the pathophysiological understanding of the vasculopathy in patients with intracerebral haemorrhage (ICH) and aneurysmatic subarachnoid hemorrhage (aSAH) and might serve as prognostic and diagnostic indicators.

The purpose of the study is to

* To evaluate the feasibility of fundoscopy, OCT and OCTA imaging in the environment of a Neurocritical Care Unit (NCCU)
* To detect, quantify and associate microvascular changes in the retina with signs of micro-vessel disease in ICH and DCI in aSAH

Eligibility Criteria:
Inclusion Criteria:

* All groups

  * Primary ICH or aSAH with symptoms onset \< 3 days
  * 18 to unlimited years of age
  * Signed informed consent obtained from legal representative or patient ICH group
  * Primary ICH localized either in basal ganglia, thalamus, pons or cerebellum aSAH group
  * Ruptured aneurysm visualized in contrast-enhanced computed tomography (angio-CT), MRI or cerebral angiography Control group
  * Stroke due to perimesencepahlic subarachnoid hemorrhage, arteriovenous malformation or isolated traumatic brain injury

Exclusion Criteria:

* All groups

  * Cerebral amyloid angiopathy or other neurodegenerative disease
  * History of migraine with aura or ischemic stroke
  * Contraindication for pupil dilation (intracranial hypertension, allergy against mydriatics, angle closure glaucoma)
  * Any pre-existing or manifest ocular condition affecting either the integrity of retinal vessels, transparency of optical media or the risk of acute angle closure glaucoma
  * Concomitant instable critical illness (e.g. sepsis, multi-organ failure)
  * Intracranial pressure \> 20mmHg and refractory to cerebrospinal fluid drainage
  * Pregnancy
The Effect of Arista on Post-Operative Bleeding and Wound Drainage Following Mastectomy

Study aim was to evaluate topical MPH on the risk of post-mastectomy seroma formation as measured by total drain output and total drain days.

Seroma formation is the most common complication after mastectomy and places patients at risk of associated morbidities. Microporous Polysaccharide Hemospheres (MPH) consists of hydrophilic, plant based, polysaccharide particles and is currently used as an absorbable hemostatic agent. An animal model evaluating MPH and seroma formation after mastectomy with axillary lymph node dissection showed a significant decrease in seroma volume. Study aim was to evaluate topical MPH on the risk of post-mastectomy seroma formation as measured by total drain output and total drain days.

Prospective randomized single-blinded clinical trial of patients undergoing mastectomy for the treatment of breast cancer. MPH was applied to the surgical site in the study group and no application in the control group.

Fifty patients were enrolled; eight were excluded due to missing data. Forty-two patients were evaluated, control (n=21) vs. MPH (n=21). No difference was identified between the two groups regarding demographics, tumor stage, total drain days, total drain output, number of clinic visits, or complication rates. On a subset analysis, body mass index (BMI) greater than 30 was identified as an independent risk factor for high drain output. Post hoc analyses of MPH controlling for BMI also revealed no statistical difference.

Unlike the data presented in an animal model, no difference was demonstrated in the duration and quantity of serosanguinous drainage related to the use of MPH in patients undergoing mastectomy for the treatment of breast cancer. BMI greater than 30 was identified as an independent risk factor for high drain output and this risk was not affected by MPH use.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Undergoing simple mastectomy with or without sentinel lymph nodes biopsy OR modified radical mastectomy for the treatment of breast cancer

Exclusion Criteria:

* Undergoing partial mastectomy
* Sentinel lymph node biopsy requiring conversion to axillary lymph node dissection
* Immediate reconstructive surgery
* Systemic anticoagulation
* Choosing not to participate in the study
Monitoring Response to Neoadjuvant Chemotherapy by the Use of Breast Proton MR Spectroscopy

This study is being done to evaluate if MR spectroscopy will give us more information about whether or not your chemotherapy will work for you. Spectroscopy is a special set of pictures taken with Magnetic Resonance Imaging (MRI) that gives us information about the chemical composition of your breast cancer.

The study aim is to perform MR Spectroscopy (1H MRS) on 1.5 Tesla (1.5T), using a software package from General Electric Medical Systems, Milwaukee, WI on 115 patients with biopsy proven adenocarcinoma of the breast, who will be receiving neoadjuvant chemotherapy as per standard therapeutic protocol, prior to surgical management. The spectroscopic data will be analyzed to determine whether this can enable early prediction of therapeutic response as assessed by RECIST and ultimately surgical pathology after the completion of the full course of drug treatment. The 1H MRS, which is performed at baseline, prior to treatment, halfway through and at the end of the chemotherapy course, just prior to surgery, will be added to the routine MRI examination for the affected breast. Since chemotherapy courses vary in length, the exact timeline will depend on the specific course given. 1H MRS will add 10 minutes to the routine MRI examination, but will not involve additional injections of contrast. In addition, we will perform two extra MRIs combined with 1H MRS examinations for the affected breast, one set the day after and the second set one week after the initiation of chemotherapy. The MRI and 1H MRS will be performed at Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, NY, NY 10021 or at any offsite of MSKCC.

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be ≥ 18 years of age
* Patients with biopsy confirmed adenocarcinoma of the breast, scheduled to receive neoadjuvant chemotherapy prior to surgical management.

Exclusion Criteria:

* Patients who would normally be excluded from undergoing an MRI examination include:

  * Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
  * Patients who are pregnant
* Patients who are unable to comply or complete the MRI exam such as patients with claustrophobia and patients who have electrically, magnetically, or mechanically activated implants, such as heart pacemakers, certain types of artificial joints, inner ear implants, eye implants, or certain surgical clips used in vascular surgery.
* Patients who are not candidates for neoadjuvant chemotherapy
Heart-Focused Breathing in Alzheimer's Disease Caregivers

This research study will explore the effects of an online heart-focused breathing intervention on 20 informal caregivers of patients with Alzheimer's Disease (AD) over a period of two weeks.

Informal caregivers are often live-in, unpaid spouses, relatives, partners, or friends that help with a loved one's activities of daily living. As a result of caring for a person with Alzheimer's Disease (AD), many informal caregivers experience caregiver burden. The demanding physical, emotional, and financial responsibilities to care for an AD patient can be detrimental to the caregiver's health.

A group of 20 men and women who consider themselves the primary caregiver of a person with AD will be recruited and enrolled into the study. Participants will be randomized into one of two study arms, (a) the modified-waitlist control arm or (b) the intervention arm. The study will explore the effects of an online heart-focused breathing intervention on heart rate variability (measured by the Welltory app on their smart device), perceived burden, stress, and quality of life in the intervention arm over a two-week period.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 years of age or older
* Live-in and unpaid informal caregiver to a loved one with Alzheimer's Disease
* Provides care or supervision for at least 4 hours per day for more than 6 months
* Experiencing stress

Exclusion Criteria:

* Caregivers who report a low risk assessment score and/or report a medically diagnosed arrhythmia or have a pacemaker will be excluded
Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects ,18-65 years of age, agreed and signed the informed consent
2. Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.
3. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
4. HbA1c 7.5-10.5% (both inclusive) at screening visit.

Exclusion Criteria:

1. Presence of any clinically significant results in examination at screening visit.
2. Uncontrollable hypertension.
3. A history of type 1 diabetes, specific diabetes, or secondary diabetes.
4. Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening.
5. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
6. Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
7. Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness.
8. Surgery is planned during the trial.
9. Mentally incapacitated or speech-impaired.
10. Pregnant or lactating woman.
11. In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
Metabolic Effects of Plant-based Diet

The purpose of this study is to assess the metabolic effects of plant based diet on healthy young adults.

An internet announcement will be made and 60 participants who meet the eligibility requirements will be randomly selected. After being informed about study, all participants (60 omnivores) giving written informed consent will be assigned to the vegan and vegetarian groups of the study according to their preferences, while 20 participants will continue to be omnivores as the control group. At week 0 and 24, blood samples, urine samples, proton density fat fraction MRI evaluations and body composition analyze will be completed.

Eligibility Criteria:
Inclusion Criteria:

1. Being 18-40 years old,
2. BMI is 18-30 kg/m2,
3. Having no chronic diseases,
4. Not smoking

Exclusion Criteria:

1. Having chronic disease,
2. Being older than 40 years old or younger than 18 years old,
3. Smoking,
4. Alcoholism or drinking more than 140 gr/week of alcohol,
Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema

The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.


Eligibility Criteria:
Inclusion Criteria:

* stable medication for the management of diabetes within 3 months
* visual impairment due to focal or diffuse diabetic macula edema
* decreased vision due to diabetic macula edema and not other causes

Exclusion Criteria:

* concomitant conditions in the study eye that could prevent the improvement in VA on the study
* active intraocular inflammation or infection in either eye
* uncontrolled glaucoma in either eye
* treatment with antiangiogenic drugs in the study eye within 3 months
* history of stroke and uncontrolled hypertension
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months

The purpose of this study is to learn about the safety of 20-valent Pneumococcal Conjugate Vaccine (PREVENAR 20) under actual clinical practice in Japan.

This study is seeking for infants aged between two months to six months who are vaccinated with PREVENAR 20 for the first time.

Infants aged between two months and six months are normally given four vaccinations. The first three vaccinations are called primary vaccinations and are given with an interval of one month between each vaccination. The fourth vaccination is called the booster and is given between 12 and 15 months of age.

Participants will take part in this study from the day of first vaccination to 28 days after fourth vaccination.

The side effects observed in the participants will be recorded and looked into.


Eligibility Criteria:
Inclusion Criteria:

1. Infants aged 2 months, inclusive, to 7 months, exclusive
2. Those without a history of pneumococcal vaccination including PREVENAR 20
3. Those who are expected to receive 4 doses
4. Those whose parent or legal guardian understands the details of the study and provides consent to provision of information collected in the study to third parties and use of the information for other purposes.

Exclusion Criteria:There are no exclusion criteria for this study.
Biological Standardization of Allergen Extracts of Pollens of Betula Pendula, Phleum Pratense and Mite Extract of Dermatophagoides Pteronyssinus

Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. Many factors such as the biovariability, differences in extraction process and subsequent handling of allergens can affect the final composition, potency, and stability of allergen preparations. Genetic diversity of affected people adds another level of complexity. In order to control variability and to achieve consistency and reproducibility for optimal safety and sensitivity/specificity, it is essential to standardize the amount of allergen used in prick tests. Therefore, the system for biological standardization mainly used in Europe still is the biological calibration of in-House Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT) value. The aim of this procedure is to estimate the biological activity of allergen extracts. The activity of an allergen extract is defined as 10,000 Diagnostic Biological Units (DBU) per ml (1 SPT per ml), when the extract provokes a specific skin reaction with a wheal of the same size as a wheal provoked by reference histamine at a concentration of 10 mg/ml, when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are clinically allergic and cutaneously reactive to the allergen concerned.

The present study aims to standardize the allergen extracts of Betula pendula, Phleum pratense and Dermatophagoides pteronyssinus by using this method.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* Positive clinical history with inhalant allergy to at least one of the allergen to be standardized.
* At least one positive prick test (mean wheal diameter = 3mm) when tested with already standardized extracts of the allergens under investigation.
* Positive prick test (wheal diameter =3 mm) to Histamine 10 mg/ml
* Age: 18-60 years
* Written informed consent

Exclusion criteria:

* Diseases or medications, influencing the skin tests or that contradict the correct conduct and evaluation of the study.
* Pregnancy, skin irritations, drug and alcohol abuse and participation in another clinical trial within the last 30 days
Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome

The objective of the study is to provide preliminary evidence for the safety and effectiveness of the AblaCare System in transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome (PCOS) who have not responded to first-line ovulation induction treatment or are contraindicated for or decline such treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥ 18 to ≤ 40 years
2. Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria: Infertility associated with chronic anovulation or oligomenorrhea, AND EITHER:

   2.1. Ultrasonographic evidence of PCOS (ovarian volume ≥ 10ml and/or ovarian antral follicle count per ovary ≥ 20) OR 2.2. Evidence of hyperandrogenaemia: either clinical (hirsutism defined as mFG level ≥ 4-6 depending on ethnicity) or biochemical (raised serum concentration of androgens (testosterone ≥ 2.5nmol/l, or FAI \> 4)
3. At least one ovary with ovarian volume ≥ 10ml
4. Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
5. Failure to respond to first-line pharmacological treatment or is contraindicated for or decline such treatment.
6. At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
7. Willing to comply with Clinical Investigation Plan-specified follow-up evaluation
8. Ability to understand study requirements and has sufficient fluency in one of the IRB-approved written translation of the Patient Information and Informed consent form
9. Signed informed consent
10. Normal sperm parameters based on WHO 2010 criteria (concentration ≥ 15 million/mL, total motility ≥ 40%, normal morphology ≥ 4%) within the last year
11. Ability to have regular vaginal intercourse during the study
12. No previous sterilization procedures (vasectomy, tubal ligation) that have been reversed

Exclusion Criteria:

1. Current pregnancy
2. Marked obesity, BMI \> 40
3. Marked hyperandrogenism (FAI \> 15)
4. Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
5. Patient not willing to stop all concomitant first-line oral medications at least 6 weeks prior to study procedure and until the 3-month endpoint is reached, and all other forms of ovulation-induction treatment until the 6-month endpoint is reached
6. Lack of capacity to give informed consent
7. Lack of capacity to follow Clinical Investigation Plan and study requirements including all study follow-up visits
8. Previous ovarian surgery: laparoscopic ovarian drilling, endometriosis surgery, ovarian cysts surgery
9. Patient with known or suspected periovarian adhesions
10. Transvaginal ultrasound transducer cannot be brought into proximity of both ovaries