cyrilzakka/clinical-trials huggingface dataset:
Autologous Bone Marrow Mononuclear Cell Implantation for Moderate to Severe Peripheral Arterial Disease

The purpose of this study is to evaluate the efficacy of dual intramuscular and intra-arterial autologous bone marrow mononuclear cell implantation for the treatment of patients with moderate to severe peripheral arterial disease in whom amputation was considered the only viable treatment option.

Study Hypothesis: Patients with moderate to severe peripheral arterial disease who receive intramuscular and intra-arterial stem cell injections will have improved ankle brachial index (ABI) measurements; relief of rest pain; ulcer healing, if applicable; and absence of major limb amputations.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age.
* Patients with moderate or severe limb-threatening PAD, defined as ankle brachial indices (ABI) less than 0.7 or presence of non-healing ischemic ulcers with stenosis or occlusion of two of the following lower extremity arteries: anterior tibial, posterior tibial, and peroneal.
* Patients with conditions that preclude recommendation of traditional endovascular or open bypass treatments.

Exclusion Criteria:

* Patients younger than 18 years of age.
* Patients who are eligible to undergo traditional endovascular or open bypass for the treatment of PAD.
* Female patients who are or may be pregnant.
* Patients who are prisoners.
* Patients with mental retardation or are unable to consent for participation independently.
Assessment of Variations of The Number of Roots &Amp; Root Canal Configurations of Maxillary Premolars and Their Relation to the Floor of the Maxillary Sinus

Assessment of Variations of The Number of Roots \&amp; Root Canal Configurations of Permanent Maxillary Premolars and their Relation to the Floor of the Maxillary sinus

Assessment of Variations of The Number of Roots \&amp; Root Canal Configurations of Permanent Maxillary Premolars and their Relation to the Floor of the Maxillary sinus in a Sample of Egyptian Population using CBCT: An Observational Cross-Sectional Study

Eligibility Criteria:
Inclusion Criteria:

* Fully maturated and erupted maxillary permanent premolars of Egyptian patients, males or females.
* Intact maxillary premolars' roots without fractures or cracks.
* Maxillary Premolars without posts or previous root canal treatment.
* CBCT scans of different fields of view could be included as long as it shows maxillary premolars.
* CBCT scans of 0.2 mm voxel resolution {the maximum voxel size accepted for endodontic imaging}

Exclusion Criteria:

* Maxillary premolars with:

Developmental anomalies. External or internal root resorption. Root canal calcification. Previous root canal treatment Post restorations. Root caries especially reaching the bifurcation area.

* Evidence of apicectomy or periapical surgery
* CBCT images of poor quality or artifacts interfering with the assessment of the root canals.
Central China Rosai-Dorfman Disease Registry

This is a research study among patients with Rosai-Dorfman disease.

Rosai-Dorfman disease is a rare disorder characterized by overproduction (proliferation) and accumulation of a specific type of white blood cell (histiocyte) in the lymph nodes of the body (lymphadenopathy), most often those of the neck (cervical lymphadenopathy). In some cases, abnormal accumulation of histiocytes may occur in other areas of the body besides the lymph nodes (extranodal). These areas include the skin, central nervous system, kidney, and digestive tract. The symptoms and physical findings associated with Rosai-Dorfman disease vary depending upon the specific areas of the body that are affected. The disorder predominantly affects mainly adolescents or young adults. The exact cause of Rosa Dorfman disease is unknown. The purpose of this research study is to learn the prevalence , therapies and long term prognosis of Rosa Dorfman disease.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of a histiocytic disorder as determined by a corroborating constellation of histopathology, clinical, and/or radiologic findings. All participants will undergo Standard of Care MRA, CTA or imaging examination.

Exclusion Criteria:

Known intracranial involvement of histiocytosis (including dura, leptomeninges and brain parenchyma) Prior stroke or intracranial hemorrhage Other (non-histiocytic) intracranial neoplasm or neurological disorder deemed by the PI or Co-PI to confound neuroimaging studies (e.g., demyelinating disease) Existing diagnosis of a psychiatric disorder or untreated mood disturbance Existing diagnosis of a neurodegenerative disease, such as Alzheimer's disease Chronic or daily excessive alcohol consumption as determined by the PI. History of chronic use of corticosteroids, defined as continuous treatment for six months or longer at any time in the past History of severe claustrophobia or other contraindications to patient SOC brain MRI Prior intravenous cytarabine or cladribine Other current or prior treatments (e.g., high-dose chemotherapy for a different cancer) deemed by the PI or Co-PI to confound imaging studies or cognitive performance
A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough

A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects with Chronic Cough

A Phase 2, multicenter, randomized, double-blind, placebo controlled, two-period crossover trial to evaluate the safety, tolerability, and efficacy of ADX-629 (300 mg) administered orally, twice-a-day to eligible participants with refractory or unexplained chronic cough. Patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 to ≤80 years of age
* History of refractory or unexplained chronic cough
* Historical Chest radiograph or CT scan that does not demonstrate any abnormality considered to be significantly contributing to chronic cough
* Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable
* Agree to discontinue antitussive medications for the trial duration

Exclusion Criteria:

* Current smoker (including cannabis products) or previous smoker having recently given up smoking or has a history of smoking of \>20 pack-years
* History of significant cardiovascular disease or any clinically significant abnormalities in rhythm or conduction
* History or presence of significant hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* History of any malignancy within 5 years of screening except for basal cell or squamous cell in situ skin carcinomas or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
* Recent history of drug or alcohol abuse or a positive urine drug test at screening
* Positive serology test for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or HIV-1 and HIV-2
* Currently taking an angiotensin converting enzyme inhibitor (ACEI) or has used an ACEI within 3 months of Screening.
Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer

This is a prospective study to assess efficacy of the Nevisense device in identifying keratinocyte skin cancer (KC) in patients suspected of having skin cancer based on the initial physician's assessment.

All skin lesions with a suspicion of Basal cell carcinoma (BCC), Invasive Squamos cell Carcinoma (iSCC), Bowen's disease (BD) or actinic keratosis (AK) and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study.


Eligibility Criteria:
Inclusion Criteria:

* All male or female patients of any ethnicity, ≥ 18 years with skin lesions of a clinical uncertain diagnosis suspicious for KC (such as BCC, iSCC, BD or AK)

Exclusion Criteria:

* Metastases of recurrent lesions
* Lesion located on acral skin, e.g. sole or palm
* Lesion located on areas of scars, crusts, psoriasis or similar skin conditions
* Lesion on hair-covered areas, e.g. scalp, beards, moustaches
* 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
* Lesion with foreign matter, e.g. tattoo or splinter
* Lesion and / or reference located on acute sunburn
* Skin surface not measurable, e.g. lesion on a stalk
* Skin surface not accessible, e.g. inside ears, under nails
Systemic Mechanisms in Allergic Rhinitis: Assessment of Metabolomic Outcomes.

This clinical study will use the Environmental Exposure Unit (EEU) to generate allergic rhinitis symptoms in participants under controlled conditions, to collect well-characterized biological samples (urine and blood) before and after they develop these symptoms. The EEU provides the ability to control the timing, duration and levels of allergen exposure, and also other outside environmental factors, yielding ideal biologic samples for analysis with novel, cutting-edge molecular techniques. Results from the analysis of these unique allergic rhinitis samples should help determine if the technique of urine Nuclear Magnetic Resonance analysis could be a useful diagnostic tool in allergic rhinitis. IgE testing will be done on blood samples and compared to spin prick testing and symptoms of allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Participant is a healthy, ambulatory male or female volunteer 18 to 55 years of age.
* Participant has a history of Seasonal Allergic Rhinitis due to ragweed for the last two consecutive ragweed seasons.
* Participant has a positive response (wheal diameter greater than or equal to 3 mm larger than diluent control) to a skin prick test to short ragweed allergen at screening or within 12 months of screening visit.

Exclusion Criteria:

* Participant is a female that is pregnant, lactating or actively trying to become pregnant.
* smokers
* Participant is unable to comply with the washout periods for prohibited medications.
* Participant is currently receiving allergen specific immunotherapy injections.
The Grandmother Study: Grandmother Initiatives in Family Transformation

CWRU Research Study: Looking for grandmothers living with grandchildren, 18 years of age or younger, to take part in a study to compare methods of dealing with the stress of caregiving to grandchildren. Participants need to have daily access to a computer, complete four surveys online, and be willing to write in a journal every day for a month. Participants will be compensated for their time.

This is a randomized clinical trial that will compare two methods of dealing with stress of grandparent caregiving to grandchildren.

Eligibility Criteria:
Inclusion Criteria:

* Grandmother to one or more grandchildren (age 18 or younger) living in the same home (with or without parents)

Exclusion Criteria:

1. Grandmothers to grandchildren who do not share their home
2. Not a grandmother
3. Not living in the United States.
Low vs. Very Low Dose of Prophylactic Tranexamic Acid for Bleeding Reduction During Rhinoplasty

The purpose of this study is to determine whether very low dose of preoperative tranexamic acid (5mg/kg) is as effective as low dose (10mg/kg) for intraoperational bleeding reduction in patients undergoing elective rhinoplasty surgery.

Background

Tranexamic acid is a drug registered for bleeding prevention and reduction. It is on the World Health Organisation (WHO) 'essential drugs list'. Preoperative tranexamic acid efficacy is well proved for doses between 10 and 40 mg/kg and last years and decades publications showed that 'low dose' (10mg/kg) is as efficient as higher doses but connected with less adverse effects.

Objectives

To determine whether 5 mg/kg dose is as effective as commonly used 10mg/kg dose in intraoperational bleeding reduction.

Methodology All patients would be randomised into one of two arms - low and very low dose. Patients, investigators and caregivers would be blinded. Patients would receive intravenous bolus of tranexamic acid at 15 minutes before admission to operation theatre in a dose dependent on the study arm. General, intravenous anesthesia (total intravenous anesthesia) would be performed due to hospital standards. At the end of the surgery total blood volume and adverse effects would be noted. Surgeon would asses surgical field in the Fromm scale.

The survey is planned for a two years timespan or until 50 patients have enrolled (25 for each arm).

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 y.o.
* American Society of Anesthesiologists Physical Status Classification (ASA) 1-2
* signed informed consent form after reading the information about the study and talking with one of the investigators

Exclusion Criteria:

* pregnancy
* known allergies for tranexamic acid or any other substance in Exacyl
* deep vein thrombosis
* Hormone Replacement Therapy or oral contraceptive usage
* anticoagulants usage
* obesity - BMI (body mass index) \>30 kg/m2
* renal disease, as glomerular filtration rate (GFR) \<60 ml/min/1,73 m\*m
* seizures or epilepsy in the past
Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth.

assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary molars with carious pulp exposure in comparison to Formocresol.


Eligibility Criteria:
Inclusion Criteria:

1. healthy children
2. with Asymptomatic primary molars with a deep carious lesion;
3. Exposure of a vital pulp by caries;
4. No clinical or radiographic evidence of pulp degeneration, such as excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction,swelling, or sinus tract;
5. Ability to perform a leakage free restoration of the teeth using stainless steel crown, or amalgam/resin based restoration.
Outcomes of Low-Impact Exercise Program for People with Ankle, Knee, And/or Hip Pain

The primary objective of this study is to study how low-impact group exercise classes affect pain scores in patients with knee, hip, and ankle pain when paired with concurrent standard of care dietitian and behavioral health consults.

Osteoarthritis is estimated to affect at least 10% of men and 13% of women over 60 years old in the United States. It's estimated roughly 1 million total joint replacements are being performed each year. Studies have suggested that for patients with knee pain that have high BMIs, low strength, and/or have not participated in conservative measures, a low-impact exercise plan when paired with diet counseling and behavioral health classes can improve patient reported outcomes scores in both pain and function. This study seeks to build upon this research and will provide low-impact exercise plans that will be paired with standard of care dietician and behavioral health interventions in order to offer patients a full-scope approach to battling osteoarthritis pain, especially for those with high BMIs, low strength, and/or for patients that have not attempted conservative therapy in the past. We will include patients with knee, hip, and ankle pain.

Eligibility Criteria:
Inclusion Criteria:

* 18 and over
* Ability to attend classes 3x weekly for 6 months with at least a 66% attendance rate
* Ability to concurrently attend standard of care dietitian and behavioral health classes for 6 months
* Joint pain (knee, ankle, hip)

Exclusion Criteria:

* Pregnant
* Prisoners
Renal Cysts and Primary Aldosteronism

During routine subtyping of confirmed primary aldosteronism by adrenal vein sampling extra plasma samples are drawn from both renal veins and from inferior vena cava. Plasma renin concentration and renin activity are analysed from these samples. Adrenal computed tomographies are analysed for cysts and other possible pathology by a blinded radiologist. Aim is to evaluate correlation between renal pathology and renin measurements.

Aim of the study is to evaluate the prevalence of renal cysts and their association with renin concentrationand acitivity in samples from renal veins and inferior vena cava (IVC) in patients who undergo an adrenal vein sampling (AVS) because of primary aldosteronism.

In a prospective study up to 200 patients who have been referred to Tampere University Hospital for AVS are recruited during 24 months. Informed consent is taken. Clinical, medication, radiological and laboratory information according to Endcrine Society guidelines is collected. Interventional radiologist will draw venous blood from both renal veins and from IVC for later renin analyses. One, blinded radiologist will record renal pathology of cysts but also other abnormal radiologic features.

An interim analysis will be done when 60-100 patients have been recruited or at 6-12 months from the start of the study. Study will be stopped if significant difference can be found in renin measurement in patients with renal cysts compared with patients without renal cysts.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed primary aldosteronism according to Endocrine Society guidelines
* Adrenal vein sampling performed in Tampere University Hospital
* Informed consent

Exclusion Criteria:

-
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104

A study to look at how radiolabelled NXL104 is taken up, broken down and removed by the body when given as an injection into the blood stream.

An Open Label Single-Dose Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite profile and Metabolite Identification of \[14C\]NXL104.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Healthy male subjects aged 30-65 years inclusive.
* Male subjects should be willing to use an adequate method of contraception (as defined in Section 5.1) from the day of dosing until 3 months after dosing with the investigational product.
* Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.
* Clinically normal physical examination and laboratory findings as judged by the investigator, including negative test results for drug abuse, alcohol, CO breath test and negative test results for Hepatitis B surface antigen, antibodies to Hepatitis C.

Exclusion Criteria:

* Any clinically significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment).
* Any clinically relevant abnormal findings in physical examination, vital signs, clinical chemistry, haematology, urinalysis, which, in the opinion of the investigator, may put the subject at risk because of his participation in the study.
* QTc \> 450 ms or QT \> 500 ms or other ECG abnormality making interpretation more difficult, as judged by the investigator, or a history of additional risk factors for Torsades de Points (eg heart failure, hypokalemia, family history of long QT syndrome).
* Radiation exposure from clinical studies, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last twelve months or 10 mSv in the last five years.
* Participation in another clinical study with an investigational product during the last 3 months.
Dengue Seroprevalence Study in Blood Donors in the French West Indies

Dengue is an infectious disease most prevalent in the world. This disease is endemic in the Caribbean, with an increase in seasonal rains. Several outbreaks have been observed in recent years, in 2001, 2005 and 2007, during which further particularly virulent serotypes have emerged. The clinical expression of dengue fever is variable, ranging from no symptoms to a classical form with fever, and even of severe or lethal bleeding. With the possible existence of silent forms of the disease, there are no data identifying the current level of protection of the population in Martinique / Guadeloupe.

1. Principal objective:

   To estimate the prevalence of the specific antibodies of the dengue (IgG) in blood donors in the French West Indies.
2. Secondary objective:

To specify the serotypic specificity of the anti-dengue antibodies detected during the study.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for blood donation following the French legislation,
* Resident in Martinique /Guadeloupe for at least one year
* Consent signed

Exclusion Criteria:

* Not Eligible for blood donation following the French legislation,
* Not Resident in Martinique / Guadeloupe for at least one year
* Consent not signed
Evaluate Performance of Callisto Eye vs. Wavetec AnalyzOR

The goal of this clinical trial is to evaluate two separate operating room cataract measuring tools in predicting the residual astigmatism (prediction error) in patients with corneal astigmatism.

The main question it aims to answer is:

Show the refractive predictability comparing the use of Operating Room cataract toric lens placement tools against the standard manual technique.

Participants will be implanted with the TECNIS Toric II IOL Lens Model ZCU; the second eye, if applicable, is to be implanted within 45 days of the first-eye surgery.

Researchers will compare two Operating Room cataract lens placement tools: the Zeiss CALLISTO vs. the Wavetec AnalyzOR to determine refractive predictability.

To evaluate two separate operating room cataract measuring tools in predicting the residual astigmatism (prediction error) in patients with corneal astigmatism (maximum allowable up to 3.0D) comparing the ZEISS CALLISTO eye and the Wavetec AnalyzOR at the one-month post-operative visit. Both surgery rooms will be using Veracity, IOL Master and Zeiss Opmi Lumera i Operating Room Microscopes. Operating Room #1 will be utilizing the ZEISS CALLISTO eye for axis alignment, along with Veracity and IOL Master for lens selection, and Operating Room #2 will be utilizing the Wavetec AnalyzOR for lens selection and axis alignment. Procedure times for the ZEISS CALLISTO eye and the Wavetec AnalyzOR will be obtained by using a start/stop watch, including phakic power calculation and toric positioning. In addition, the suction on (start of LenSx), treatment time of LenSx in seconds, suction off (end of LenSx), start time of primary incision, the beginning of Phaco, end of phaco, CDE (Combined Diffused Energy) total and the end time of procedure will all be documented. All times will be analyzed and compared between Operating Room #1 and Operating Room #2.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral cataract extraction with single piece hydrophobic acrylic posterior capsular intraocular lens correcting astigmatism.
* Clear intraocular media other than cataract.
* Willing and able to complete all required postoperative visits.
* Able to comprehend and sign a statement of informed consent in English.

Exclusion Criteria:

* Ocular disease or pathology that, in the opinion of the Investigator, will affect the post-operative visual acuity and manifest refraction.
* Prior intraocular or corneal refractive surgery, corneal transplant, or retinal detachment.