cyrilzakka/clinical-trials huggingface dataset:
The Haemodynamic Effects of Mechanical Standard and Active Chest Compression-decompression During Out-of-hospital CPR

The aim of this randomized out-of-hospital cardiopulmonary resuscitation study is to investigate haemodynamics generated by the standard mechanical external chest compression device (LUCAS™ 2) compared to a new version generating chest compressions and active decompression above the initial starting position of the suction cup (LUCAS™ 2AD).

Based on randomization patients will receive standard or active compression decompression chest compression and the haemodynamic effects will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Unexpected adult out-of-hospital non-traumatic cardiac arrest where an attempt of resuscitation is considered appropriate in:
* Patients 18 years or older

Exclusion Criteria:

* Traumatic cardiac arrest
* Age believed to be less than 18 years
* Known pregnancy
* Victim not to be resuscitated (DNR orders)
* Internals in prison
* Included once in the study already
* To Small/Large patients
* Sustained ROSC occurring before the LUCAS™ 2 or LUCAS™ 2-AD can be applied to the patient, such that further CPR is not needed
Combination Chemotherapy for the Treatment of Indian Kala-Azar

The investigators are using a sequential design to combine miltefosine and AmBisome in different doses.

In this sequential design four arm study one arm is a reference arm but the three arms will consist an of initial dose of liposomal amphotericin B on first day followed by miltefosine. Both the drugs will be used in different doses. Reference arm will consist only a single dose of amBisome at 5 mg/kg. After the end of treatment, the post treatment assessment will be done on day 16 (initial cure) and six months (final cure). Safety parameters will be evaluated on day 0, 8 and 16. An arm with an efficacy of less than 75% will be closed. There will be periodical assessment of study results after completion of 5 patients in each arm.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of active VL with consistent signs and symptoms (e.g., fever, splenomegaly).
* Confirmed diagnosis by bone-marrow or splenic aspirate smear showing characteristic amastigotes.
* Male or female.
* Ages 12 to 65 years.
* Both newly diagnosed cases and patients who have received previous treatment (in the latter case a 2-week wash-out will be required before starting the study treatment).
* WBC \> 1,000/mm3.
* Hemoglobin ≥ 4 g/dL

Exclusion Criteria:

* Pregnancy or breast-feeding.
* HIV positive serology.
* ASAT, ALAT, AP ≥ 3 times upper limit of normal range.
* Bilirubin ≥ 2 times upper limit of normal range.
* Prothrombin time ≥ 5 seconds above control.
* Serum creatinine or BUN ≥ 1.5 times upper limit of normal range.
* Any medical condition or situation that compromises compliance with study procedures.
* HIV
Treatment of Periorbital and Perioral Wrinkles With the Applications of the Iluminage Diode Laser

The Diode laser system is being used in this marketing study for the treatment of wrinkles around the eyes and mouth.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are healthy females between 35 and 60 years of age.
2. Subjects who have Fitzpatrick skin type I-VI
3. Subjects who have provided written and verbal informed consent
4. Subjects who are willing and able to comply with study instructions and to return to the clinic for required visits and have photographs of their face taken
5. Subjects who have perioral and periorbital wrinkles, as deemed appropriate by the Investigator or his designees

Exclusion Criteria:

1. Subjects who currently use or have used in the prior 30 days any skin products that contain alpha hydroxy acids (AHA) e.g. glycolic, lactic, citric, or mendelic acid containing products or retinol/tretinoin containing products or exfoliating washes, masks or scrubs or other micro-dermabrasion skin care products. on the laser application areas
2. Subjects who are unwilling to maintain their daily skin care regimen for the duration of the study,
3. Subjects who have any skin pathology or condition that could interfere with the evaluation i.e. personal or family history of skin cancer, rosacea and/or requires the use of interfering topical or systemic therapies.
4. Subjects with synthetic or metal implants or permanent cosmetic tattoos in the test areas
5. Subjects who have a history of abnormal scarring, e.g. keloids or have significant scarring in the areas to be treated
6. Subjects with bleeding disorders or taking anticoagulation medications, including heavy use of aspirin
7. Subjects who have participated in any clinical investigation involving the face within the 30 days prior to the first planned laser application or subjects who plan to participate in concomitant facial studies during this trial
8. Subjects, who are pregnant, were pregnant or gave birth in the last 3 months, are currently breast feeding, or might become pregnant during the course of the study
9. Subjects who have a history of light triggered seizures
10. Subjects with prior use of neurotoxins e.g. Botox®, collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) of the face or having had chemical peels within 6 months of initial laser application or planning to so during the course of the study
11. Subject's use of oral isotretinoin (Accutane®) within 12 months of initial laser application or during the course of the study
12. Subjects having had facial skin treatments with any professional laser, light based, radiofrequency or other devices within the last year
13. Subjects ever having facial skin treatments with home use laser, light based or radiofrequency or other devices, i.e. PaloVia® or Tria®
Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers

Surgery is the primary curative option for patients with cancer, with the overall objective of complete resection of all cancerous tissue while avoiding damage to healthy tissue. In addition, sentinel lymph node (SLN) mapping and resection is an essential step in staging and managing the disease. Even with the latest advancements in imaging technology, incomplete tumor resection in patients with breast cancer is at an alarming rate of 20-25%, with recurrence rates of up to 27%. The clinical need for imaging instruments that provide real-time feedback in the operating room is unmet, largely due to the use of imaging systems based on contemporary technological advances in the semiconductor and optical fields, which have bulky and costly designs with suboptimal sensitivity and co-registration accuracy between multimodal images.

To address these challenges, the investigators have introduced an innovative design comprising a bio-inspired multispectral sensor which can significantly improve image-guided surgery. The objective of this clinical study is to determine the feasibility of using a bio-inspired multispectral imaging system to detect sentinel lymph nodes and cancerous tissue during intraoperative procedures in patients with breast cancer.

Per current standard of care for patients with breast cancer, three different tracers will be injected in the participants: technetium radiocolloid, indocyanine green and methylene blue. Initially, the surgeon will identify the location of the sentinel lymph node per standard of care by using a handheld gamma-probe and by visual inspection of the wound site. While the surgeon is locating the sentinel lymph nodes in the underarm surgical wound site, the investigators will be recording the fluorescent signals from the same site with the bio-inspired multispectral camera.

All resected tissue from the patient will be imaged with the multispectral camera before sending samples for pathology analysis. Results obtained from the multispectral cameras will not be presented to the surgeon during the surgery in order not to influence their surgical decision.

Eligibility Criteria:
Inclusion Criteria:

* early or progressive stage of breast cancer
* able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* inflammatory cancerous tissue
* pregnant women
* history of allergic reactions to iodide or seafood allergy
* sentinel lymph nodes were not detected with radiocolloid and static gamma camera
* patients have previous breast surgery
* patients who were unwilling to enter the study
Short- and Long-term Health Consequences of Workers During Consecutive Days of Heat Stress

The purpose of this study is to measure fatigue and indicators of acute kidney injury during consecutive days of work in a hot environment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Regularly completes aerobic exercise at least 60 min per week

Exclusion Criteria:

* History of cardiovascular, metabolic, respiratory, neural, or renal disease
* Hypertensive or tachycardic during the screening visit (Systolic Blood Pressure \> 139 mmHg, Diastolic Blood Pressure \> 89 mmHg, heart rate \> 100 bpm)
* Current tobacco or nicotine use or previous regular use within the past 2 years
* Current or previous musculoskeletal injury limiting physical activity
* Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
* A positive pregnancy test at any point during the study or currently breastfeeding
* Study physician discretion based on any other medical condition or medication
The Cedars-Sinai Smidt Heart Institute Takotsubo Registry & Proteomic Study

The Cedars-Sinai SHI Takotsubo Registry and Proteomic Study is an observational registry that will collect retrospective and prospective demographic, clinical, hemodynamic, laboratory and other diagnostic parameters, therapy and outcome data from individuals who meet the inclusion/exclusion criteria of Takotsubo Registry protocol. Subjects will also be invited to provide a blood sample utilizing a Mitra kit sent to their homes. Researchers from the Barbra Streisand Women's Heart Center will analyze Registry data to identify Takotsubo phenotypes, improve diagnostic capabilities, better predict recurrence rates, and develop targeted Takotsubo treatments.

Registry outreach will begin with an informational and inspirational website and will utilize social media and patient-driven activism through Facebook, blogs and Twitter modalities that have demonstrated efficiencies in other patient-centered research efforts. Subjects will upload specific clinical materials into Cedar-Sinai's web-enabled cloud storage and which will be screened by trained Smidt Heart Institute physicians. The Registry utilizes on-line, e-consent and enrollment connected to a REDCap database that will allow efficient data input for analysis. All potential subjects who have been diagnosed with Takotsubo or have been informed by their physician that they meet diagnosis criteria, will need to provide information for review that includes: hospitalization records, from the time of Takotsubo event, with laboratory data (particularly -- troponin level), ECG and CTA. Registrants will be asked to respond to annual update surveys.

The goal is to accurately understand the prevalence, recurrence and prospective status of the Takotsubo, to determine which individuals are at risk of reoccurrence or subsequent adverse event and to determine potential treatment targets to develop therapeutic strategies

Primary:

* To establish a large USA-based database for patients with Takotsubo with a convenient and easy to use on-line patient-advocate registry using digital media marketing, Box cloud data access and storage, accurate case adjudication, and automated follow-up.
* Participants will also be offered the option of participating in the Takotsubo Proteomic Registry by providing remote ambulatory Mitra blood samples.

Secondary:

• To establish a clinical trial platform for patient-centered point-of-care trials to improve diagnostics, clinical care and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Have received a diagnosis of Takotsubo from their physician and consent to enroll
* Submit full medical records needed for Takotsubo adjudication

Exclusion Criteria:

* Younger than 18 years
* Unable to provide informed consent
* Unable to provide the necessary documentation needed for screening purposes
Empower@Home: A Feasibility Pilot

This is an open pilot feasibility study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 15 older adults throughout the state of Michigan to better understand the feasibility of the intervention and to probe preliminary effects. The intervention will take approximately 10 weeks to complete. Participants will have lower levels of depression after completing the intervention than before enrollment. Participants will be able to use the internet-based platform with minimal support.

Depression affects up to 40% of homebound seniors. The purpose of this research project is to assess the feasibility, acceptability, and preliminary effects of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. Our team developed Empower@Home collaboratively with older adult stakeholders and social service providers. It is the first iCBT program tailored for low-income racially diverse homebound seniors. It has the potential to reduce access barriers to mental health services among this high-need population. Although Empower@Home is based on an evidence-based mental health treatment (i.e., CBT), it is a novel intervention and has not yet been tested with human subjects. This is a pilot study that involves testing the feasibility, acceptability, and preliminary effects of the intervention with a single group of participants in an open trial. No randomization will occur. All eligible participants who consent will receive the intervention. A total of15 older adults will be recruited to participate in this study. All of them will be recruited through referrals from 2 to 3 social service agencies on this list (The Information Center, Region 2 Area Agency on Aging (AAA), Senior Resources, and A \& D home care). The intervention involves attending up to 10 pre-recorded online therapy sessions and receiving weekly maintenance calls from trained research assistants for up to 12 weeks. Participants will engage in therapy at their private homes. A comprehensive baseline and post-test will be administered either over the phone or via an online survey, depending on the participants' preference. No in-person interaction between the participants and the research team is anticipated during the active treatment phase unless intervention is warranted for subjects' safety. Quantitative and qualitative data will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. ≥60 years
2. have at least mild depressive symptoms, based on PHQ-9 \>=5
3. are willing to participate

Exclusion Criteria:

1. Currently receiving CBT or iCBT
2. Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score \>= 10).
3. They do not speak English
4. have active suicidal ideation (any positive response on the 9th item of PHQ-9)
5. Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months
6. Severe hearing or vision problems that prevent them from using a tablet/computer or viewing online content
Study Evaluating Rapamune in Patients After Kidney Transplantation

The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions


Eligibility Criteria:
Inclusion Criteria:

* Patients having received a renal allograft from a cadaveric or living donor with low or moderate risk of developing acute rejection episodes.

Exclusion Criteria:

* Contraindications according to Summary of the Product Characteristics (SmPC).
Extended-release Injectable Buprenorphine for Individuals at High Risk of Overdose

This pilot study will evaluate the feasibility and clinical utility of extended-release injectable buprenorphine (XR-BUP) for the treatment of opioid use disorder (OUD) among individuals at high-risk for overdose (OD).

FASTER-BUP is a 24-week observational pilot study evaluating the feasibility and clinical utility of XR-BUP (brand name: Sublocade) for the treatment of OUD among individuals at high-risk of OD. Forty participants with moderate to severe OUD starting treatment with XR-BUP as part of standard of care will be followed.

Eligibility Criteria:
Inclusion Criteria:

Participants must meet ALL the following criteria to be eligible to participate for the study:

1. Be above 19 years of age;
2. Be diagnosed with moderate or severe OUD as evidenced by their approval for treatment with XR-BUP (Sublocade);
3. Be at high-risk for recurrent overdose, defined as having experienced a recent non-fatal overdose within the past 6 months (e.g., admission to the emergency department for an overdose OR self-reported OD that required Naloxone administration OR had an overdose where an ambulance arrived at the scene);
4. Have a new prescription for XR-BUP, but have not yet initiated treatment;
5. Be able and willing to follow study procedures;
6. Be able to provide adequate locator information (e.g., phone number and at least one emergency contact);
7. Be able and willing to provide written informed consent;
8. Be able to understand, communicate and speak with the research staff. Non-English speaking individuals will require a translator to be present during all study visits and during all study activities. The translator will be independent (e.g., not known to the participant to prevent the risk for coercion or misrepresentation).

Exclusion Criteria:

Participants will be excluded from the study if ANY of the following criteria are met:

1. Be on OAT other than buprenorphine/naloxone in the 7 days prior to screening;
2. Be on a stable buprenorphine/naloxone dose for more than 27 days prior to screening;
3. Use of an investigational drug in the 30 days prior to screening;
4. Incarcerated, pending legal action or other reasons that might prevent completion of the study.
SciBase International Melanoma Pivotal Study

The purpose of this clinical investigation was to determine the safety and effectiveness of the SciBase III device (Test) designed to help distinguish between malignant melanoma and benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological gold standard (Reference).

The purpose of the study is to collect data to support a Pre-market Application(PMA) to obtain Food and Drug Administration(FDA) approval to market the SciBase III Electrical Impedance Spectrometer.


Eligibility Criteria:
Inclusion Criteria

For inclusion in the study, all subjects had to fulfill all of the following criteria:

* Men or women of any ethnic group aged ≥18 years
* Primary lesions (i.e., not metastases or recurrent lesions) that the physicians choose to excise.
* Lesion ≥ 2 mm in diameter and ≤ 20 mm in diameter
* In subjects with multiple skin lesions, all lesions destined for excision must be identified for purposes of study participation. Note: a subject may only be entered into the study once.
* The subject is willing and able to read, understand and sign the study specific informed consent form.

Exclusion Criteria:

Subjects were excluded from the study if they fulfilled any of the following criteria:

* Skin surface not measurable, e.g. lesion on a stalk
* Skin surface not accessible, e.g. inside ears, under nails
* Lesion located on acral skin, e.g. sole or palms.
* Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions.
* Lesion on hair-covered areas, e.g. scalp, beards, moustaches or whiskers.
* Lesion located on genitalia.
* Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized.
* Lesion located on mucosal surfaces.
* Skin is not intact (measurement area) e.g. bleeding or with clinical noticeable ulceration.
* Lesion with foreign matter, e.g. tattoo, splinter
* Lesion and/or reference located on acute sunburn.
Effect of Intravenous Administration of Mannitol on ONSD in Patients With Raised ICP

Osmotherapy with mannitol has been a common practice in patients with raised ICP. Monitoring its effect on ICP can be performed invasively and non-invasively. Due to a validated correlation between invasive ICP monitoring and ONSD measurement, it can be a tool to monitor acute and long term effects of osmotherapy non-invasively on ICP. This study examines the acute changes in sonographically measured ONSD brought about by the administration of mannitol. This can correlate with the changes in ICP in such patients and can be utilized as a tool for decision making/ point-of-care utility.

This is a prospective cohort based observational study including 40 patients admitted in the adult ICU at our center diagnosed as either a case of TBI/ acute stroke/ intracranial hemorrhages with a mean screening ONSD of more than 5mm under mannitol osmotherapy. ONSD were measured by a high frequency linear array probe (\>10 Hz) at the time of screening. Mannitol was then administered at doses prescribed by the treating physician over 20-30 minutes via a dedicated intravenous line. ONSDs were measured again at 30, 60 and 120 minutes after completion of administration of mannitol. Demographic data, baseline ventilator parameters of patients on mechanical ventilation, GCS and mean arterial pressure at each time points were recorded. Comparison of variables at these time points were made.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* diagnosed as a case of TBI/ acute stroke/ intracranial hemorrhages
* screening mean ONSD \> 5 mm
* under osmotherapy with mannitol in standard doses (0.25 - 1 gm/kg)

Exclusion Criteria:

* baseline ocular pathology like tumors, Graves' disease and sarcoidosis
* previous ocular surgery
* Decompressive cranial surgery
Improving Motor Skills: The Role of Music and Encouragement

This study used a randomised crossover design to analyse the effect of three different experimental interventions - i.e. standard conditions, music and verbal encouragement - on performance in an isometric endurance task, comparing results between untrained and trained individuals. The interval between each intervention was set at seven days. The outcome measures are muscle activity and fatigue, assessed by surface electromyography, and task duration.

Isometric endurance task requires participants to keep their arm flexed at a 90° angle while holding a dumbbell with a supine grip loaded to 80% of 1RM on the dominant side of the body. During execution, the back and head should remain in contact with a vertical wall, with the feet shoulder width apart and firmly planted on the floor. The bar is held with the dominant arm while the other arm remains in a neutral position close to the body. It is imperative to avoid any form of rocking or movement that would make it easier to maintain the position. The test officially begins when the bar is handed to the subject, who is already in the correct position, and ends as soon as the angle of the arm varies by more than five degrees from the starting position.


Eligibility Criteria:
Inclusion Criteria:

To be included in the study, candidates had to be in good general health, with no medical conditions that could interfere with their ability to perform the test safely and effectively. In addition, to be considered trained, participants had to have performed 150 minutes per week of vigorous-intensity aerobic physical activity, in addition to muscle-strengthening activities, on at least two days per week. Those who did not meet this standard were considered untrained.

-

Exclusion Criteria:

Exclusion criteria included a history of surgery to the arm, shoulder, or nearby areas that could limit the ability to perform the test. The use of medications that affect muscle function or pain perception was also a reason for exclusion, so that the test results could not be influenced by external factors.

-