cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study to Assess Novel Ointment in a Psoriasis Plaque Test

To investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris

The study will be performed in 12 male subjects with stable psoriatic plaques. The study preparations and the comparators will be tested observer-blind. Treatments will be randomly assigned to the test fields. All subjects will receive all treatments, with intraindividual comparison of the treatments.

Altogether six test fields will be examined per subject (three active AN2728 ointments of different concentrations: 5 %, 2 % and 0.5 %, the active ingredient-free vehicle, a marketed corticoid preparation and a marketed topical immunomodulator). The test fields will be treated occlusively over a study period of 12 days. A topical application of approximately 200 uL of each assigned intervention will be administered per treatment, for a total of 10 treatments over a 12-day treatment period.

Eligibility Criteria:
Inclusion Criteria:

* male subjects aged 18 years or older;
* subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with an area sufficient for six treatment fields;
* the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
* written informed consent obtained.

Exclusion Criteria:

* subjects who require systemically acting medications for the treatment of psoriasis, which might counter or influence the study objectives, e.g. corticosteroids, cytostatics;
* local treatment with antipsoriatics (except for salicylic acid in vaseline) in the 4 weeks preceding and during the study (corticosteroids 8 weeks);
* systemic treatment with antipsoriatics in the three months preceding and during the study;
* treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, e.g. β-blocker, antimalarial drugs within two weeks before the beginning of the study and during the study;
* known allergic reactions to the active ingredients or other components of the study preparations or comparators;
* evidence of drug abuse;
* UV-therapy within four weeks before beginning and during the study;
* symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
* participation in another clinical trial involving pharmaceutical products in the four weeks preceding and during the study;
* in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent.
* subject is institutionalized because of legal or regulatory order.
Is There Intravascular Hemolysis in Patients With Pulmonary Hypertension?

Patients with hemolytic disorders (e.g. sickle cell anemia or thalassemia) are known to develop pulmonary hypertension. Hemolysis is where red blood cells are destroyed and their contents released into the circulation. It is thought that these red-cell contents cause constriction and thrombosis of the blood vessels in the lungs. Conversely, it is possible that patients with pulmonary hypertension have hemolysis.

In this study we will be drawing blood from a range of patients and normal controls for a panel of blood tests related to hemolysis.


Eligibility Criteria:
Inclusion Criteria:

One of the following four conditions :

* Pulmonary artery hypertension
* Obstructive sleep apnea with pulmonary hypertension
* Lung transplant candidates without pulmonary hypertension
* Normal Controls

Exclusion Criteria:

* Known hemolytic disorder
* Recent blood loss (\<3 months)
* Recent blood transfusion (\<3 months)
* Liver disease
An Intervention to Preserve Functional Status and Independence Among Community Dwelling Elderly

This is a study aimed at identifying Olmsted County senior citizens who are at risk for vulnerability. Those elders who screen "affirmatively" for vulnerability will be offered participation in a pilot intervention aimed at keeping seniors independent in the community. This intervention consists of a comprehensive geriatric home visit and the development of an individualized action plan aimed at preservation of function and independence. Participants will be followed for several months after their baseline assessment to evaluate implementation of recommendations.


Eligibility Criteria:
Age 65 or older Olmsted County Resident Able to provide own consent English speaking or with available translator
Effectiveness of a Paleolithic Based Diet Compared to MyPlate Guidelines, With and Without Exercise, in Women.

The purpose of this study is to determine the effectiveness of recommending either a Paleolithic based diet or the United States Department of Agriculture MyPlate guidelines with or without exercise on physical conditioning, hormones related to energy metabolism, body composition, resting energy expenditure, blood biomarkers, and urine in young, adult females.


Eligibility Criteria:
Inclusion Criteria:

* body fat percent between 20 and 38
* less than 150 minutes of exercise per week at 4.5 or greater Metabolic Equivalent of Task
* not pregnant, trying to become pregnant or lactating
* non-smoker
* no previous resistance training
* have not been on a diet in the past three months
* no dietary restrictions (food allergies, disease conditions, etc)
* have not lost more than 10 lbs. in the past three months

Exclusion Criteria:

* taking any medication
* women who have had a left breast mastectomy
* do not meet criteria of PAR-Q
The Application Value of Non-contact Infrared Thermometers in Temperature Screening in the General Population

The first epidemic of 2019 novel coronavirus (2019-nCoV)-infected pneumonia(NCIP) in Wuhan, China, has attracted global attention because of its strong transmission ability and certain fatality. Analyzing the clinical data of hospitalized patients with 2019-nCoV infection, the current studies found that fever, fatigue and dry cough were common symptoms, and 43.8% of the patients showed fever before admission. Some scholars emphasize that the most effective means to control the outbreak are early detection, early isolation, early diagnosis and early treatment. In the face of the pressure that a large number of people need rapid screening and the deficiency that the forehead temperature measurement is easily affected by the environment, the investigators would like to explore the accuracy and advantages of wrist temperature measurement in different environments and conditions in this period. And determine the thresholds of non-contact infrared thermometer for the screening of patients with fever, in order to provide clinical indicators for further detection of patients with suspected fever.


Eligibility Criteria:
Inclusion Criteria:

* patients, family members of patients, and medical staff

Exclusion Criteria:

* age \<= 18 years
* Wearing hearing aid, having a cerumen
* Soft tissue infection, trauma patients
* Missing data
Auto Control of Volume Management for Limb Loss

The aim of this research is to create a prosthetic system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using their prosthesis.

People with lower limb amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb health problems including skin breakdown and injury to deeper tissues. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day.

The objective of this research is to develop and test an automatically-adjusting prosthetic socket system for prosthesis users. The system integrates with a range of adjustable socket technologies, including those that are commercially available. The system allows small size adjustments for both tightening and loosening the socket. In early aims of the study, the prosthesis will be adjusted manually, but can be controlled remotely, eliminating the need to remove the prosthesis or bend down to make adjustments. The system will later be enhanced to automatically change the fit of an adjustable socket at the appropriate times, without distracting the user. We hypothesize that this system will help to maintain consistent limb fluid volume while the prosthesis user is wearing the socket and that socket fit will be improved. The system functions by continuously collecting measurements from sensors within the socket and uses small motors to control adjustable panels in the socket wall.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Unilateral transtibial amputee
* At least 6 months post-amputation
* Wear prosthesis at least 3 hours per day
* Use an elastomeric (i.e. gel) liner
* K3 or higher Medicare Functional Classification Level
* Able to walk continuously with prosthesis for at least 5 minutes at a time, sit, stand, and step up a height of 5.0 cm.
* Residual limb of 9.0 cm or longer
* Experience problems with volume fluctuations that affect their prosthetic socket fit

Exclusion Criteria:

* Participants experiencing skin breakdown on enrollment will be excluded, but can enter after having been free of clinically visually-apparent skin breakdown for two weeks.
Gather mHealth India RCT for Behavior and Health Outcomes

The purpose of this trial is to explore the impact of the Gather Health diabetes management platform diabetics' health behaviors and health outcomes and how providers and diabetics interact with the Gather Health platform.

The overall aim of the study is to estimate the impact of the Gather Health diabetes management platform on HbA1c, glycemic control, patient behavior, and physical and psychosocial measures. Additionally, this study will investigate patient and provider satisfaction with the platform.

Primary Objective:

Estimate the impact of the Gather Health diabetes management platform on HbA1c among diabetics in 3 cities in India.

Secondary Objective:

1. Estimate the impact of the Gather Health diabetes management platform on medication adherence, blood glucose (BG) control, body mass index (BMI), blood pressure (BP), and other behavior and health measures among diabetics in 3 cities in India.
2. Estimate patient and provider's satisfaction with the platform and the perceived usability and time spent on the platform
3. Generate ideas for future changes to the platform to make it more effective and user-friendly

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus, diagnosis for \> 6 months.
* Age 18-65, participants of either gender- males or females.
* HbA1c between 7.5% and 12.5% within last 6 months (inclusive).
* On stable diabetes therapy for \>3 months prior to enrollment.
* Own an Android Smartphone.
* Participant willing to sign and date written Informed Consent Form to participate in the study.
* Willing to comply with the study schedule and procedures including randomization.

Exclusion Criteria:

* Previously used Gather Health
* Currently using an insulin pump or continuous glucose monitor.
* Pregnant or planning to become pregnant in the next 12 months.
* Severe hearing or visual impairment.
* Active substance, alcohol, or drug abuser (sober \<1 year).
* Any psychiatric illness including psychosis or schizophrenia that will impair the patient's ability to complete the study or follow study protocol.
* Recent major surgery or planning to have major surgery
* Significant renal, hepatic, or other disease that may impair patient's ability to complete the study or follow study protocol
* Using glucocorticoids
* Patients who have received or are planning to receive an organ transplant
Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars

The aim of the study is to assess the efficacy and safety of the combination of intralesional triamcinolone (at doses of 4mg / cm2 at intervals of 4 weeks) and topical pirfenidone 8% (every 8 hours continuously) compared with their isolated application, in the treatment of keloid scars in adults. The duration of this three-arm clinical trial will be 12 months, a 6-month period for treatment and a follow-up of 6 months to assess recurrences. The estimated number of persons to be recruited and randomized for the study is 102.

Individuals with keloid scars will be randomized to 3 arms of treatment in order to assess the efficacy of combining intralesional triamcinolone and topical pirfenidone compared with the isolated application of these drugs. The interventions will last 6 months but the individuals will be assessed monthly to determine recurrences for 6 more months. The scar size will be measure at weeks 12, 24 and 52.

Eligibility Criteria:
Inclusion Criteria:

* Keloids size equal or major than 1 cm
* Keloids less than 5 years old
* Keloids in trunk

Exclusion Criteria:

* Keloid with a surgical indication
* Hypertrophic scars
* Scars after burn wounds
* Pregnancy
* Lactation
* Use of systemic chemotherapeutics or chronic use of systemic corticosteroids or immunosuppressive medication
* Known hypersensitivity for triamcinolone or pirfenidone
* Severe comorbidity not controlled
* Inflammatory acne
* Diabetes Mellitus
* Hypertension
* Renal, hepatic or respiratory failure
* Topical treatment 4 weeks before recruitment
* Previous treatment with intralesional steroids
Impact of Vascular Calcification and CASR Expression by Monocytes in Septic Shock

In septic shock, bacterial LPS is able to activate the CaSR of cardiomyocytes inducing their apoptosis in vitro. CaSR activation in monocytes is responsible for activation of the NLRP3 inflammasome and macropinocytosis. In front of this immune axis, a variation in the monocyte expression of the CaSR is expected in the state of shock. This is already observed in other pathologies such as renal failure or in animal models of severe burns. If this is considered as an overall reflection of CaSR expression in the body, it would be consistent with the phosphocalcic disturbances associated with septic shock. The phosphocalcic balance is often modified, and not treated during the acute episode, with in particular hypocalcaemia which could be consecutive to a hyperactivation or overexpression of the CaSR. This study proposes to explore for the first time the expression of monocytic CaSR in patients in a state of shock, with possible therapeutic perspectives by the existence of calcimimetics and calcilytics. In this study, the investigators propose to explore the CasR and its implication in septic shock in a three - part protocol : measurement by flow cytometry of monocyte expression of CASR (primary objective) and CD33, CD14, CD163, CD16 and HLA-DR), survey of clinical and biological parameters in patients with septic shock and healthy volunteers and acquisition of calcium score in patients with septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients over the age of 18,
* patients who have not participated in a study evaluating an investigational drug in the 30 days preceding the samples,
* intensive care patients in a state of septic shock within the first 24 hours of the introduction of pressor amines,
* French resident year-round,
* lactate \> 2mmol/L,
* patients with social security coverage.

Exclusion Criteria:

* Patients in hemorrhagic shock,
* history of parathyroidectomy, patient with hypersecretion of PTHrp,
* sarcoidosis,
* genetic disturbance of CaSR including familial hypocalciuric hypercalcaemia,
* current immunosuppressant treatment (anticalcineurin, mTOR inhibitor, methotrexate, high-dose corticosteroids excluding hydrocortisone and fludrocortisone),
* chronic myelomonocytic leukemia,
* patients with febrile neutropenia,
* patients with acquired or constitutional immune system,
* pregnant or breastfeeding patient,
* patients under curators, guardianship or safeguard of justice.
ALgorithms Adapted From Remote Monitoring

Through the aid of remote monitoring and early symptom detection, a patient's response to stress and normalization to their individual baseline can better contribute towards algorithms which are predictive of clinical decline.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Scheduled to undergo surgery resulting in a complex recovery as evaluated by the treating Department of Surgery surgeon. This includes but is not limited to the following inpatient elective surgery procedures: esophagectomy, pancreatectomy, major liver resections, open vascular surgery, lower extremity bypass, colectomy, and complex pulmonary resections (lobes and above).
* Subjects are committed to daily exercise as outlined in the protocol.

Exclusion Criteria:

* \<18 years of age
* Subject is pregnant
* Subject is dismissed from the hospital to a nursing home or long term care facility.
* Subject cannot commitment to daily exercise as outlined in the protocol.
* Subjects enrolled in another device or drug study does not necessarily preclude them from participating in this study. Please check with the PI for inclusion if the subject is on another device or drug study.
Comparison of Erector Spina Plane Block and Thoracic Epidural Block

The aim of this randomised controlled and double-blind study, is to compare the effects of erector spinae plane (ESP) and thoracic epidural (TEA) blocks on peri-operative hemodynamics and analgesia in patients undergoing unilateral mastectomies due to malignancy.

Patients will be randomised into two groups as Group E (those who received general anesthesia after the erector spina plan block) and Group T (those who received general anesthesia after thoracic epidural block).

After the block skin conductivity (galvanic skin response - GSR), body temperature changes, sympathetic and sensory block levels, peri-operative hemodynamic data, postoperative pain scores and analgesic consumption will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA(American Society of Anesthesiologist) physical classification I-III
* Patients undergoing unilateral mastectomies due to malignancy

Exclusion Criteria:

* Active infection at the intervention site
* History of coagulopathy or anticoagulant use (less time has passed before peripheral and central blocks)
* Major cardiac, pulmonary, renal and neurological diseases
* Autonomic neuropathy or use of drugs that affect autonomic function
* Patients with type 1 diabetes or insulin dependent type 2 diabetes over 10 years
* Allergic to local anesthetics;
* Patients who are uncooperative or have psychiatric problems
* Morbidly obese (body mass index \> 35 kg/m2)
Evaluating Mental Health Improvements After Using Home Phototherapy Device With UVB LEDs

The primary objective of this study is to evaluate the satisfaction of users with the MySOLIUS device by a non-professional in a home use environment. The secondary objective of this study is to demonstrate the safety and effectiveness of the MySOLIUS device in the improvement of mood/quality of life score.

After being informed about the study and potential risks, all patients giving written informed consent will be screened to determine eligibility for study entry. Participants who meet the eligibility requirements will be sent a study device to use in their home environment. Prior to beginning treatment with the device, participants will fill out a quality of life questionnaire. Participants will use the device twice per week, once for treatment on the front side and once for treatment on the back side of the body. Participants will use the device twice a week for 16 weeks, for a total of 32 treatments. After the 16 week treatment duration, participants will fill out a final quality of life questionnaire and a device usability questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age 18 years or older with Fitzpatrick skin types 1,2,3,4,5 and 6.
* The patient can understand the information provided to them and who have given written informed consent to the study.
* The patient can understand and complete self-administered questionnaires.
* The patient is able and willing to follow study procedures.
* Women of child-bearing potential must confirm use of an effective contraceptive for 30 days prior to enrolling and continued use throughout the study or have a negative pregnancy test.

Exclusion Criteria:

* History of underlying photosensitivity.
* Subjects who are pregnant
* Patients that have granulomatous disorders (such as sarcoidosis).
* Use of medications that cause a photosensitivity reaction.
* History of skin cancer in the last 5 years.
* Patients with history of hypocalcemia (calcium \<8.6mg%), hypercalcemia(calcium \>10.6mg%).
* Taking drugs known to influence vitamin D metabolism, such as glucocorticoids,antiseizure medications, or HIV/AIDS medications.
* Patients with a history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease within 3 months.
* Intentional artificial UV exposure (e.g. tanning bed, UVB phototherapy use) in the last 60 days or planned use while participating in the study.
* Participation in an investigational drug study within 30 days of the screening.
* Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.