cyrilzakka/clinical-trials huggingface dataset:
Vibro-Acoustography Imaging in Finding Breast Microcalcifications and Lesions in Women

RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of finding microcalcifications and lesions in the breast.

PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in finding breast microcalcifications and lesions in women.

OBJECTIVES:

* To further develop a new method of in vivo imaging of the breast using vibro-acoustography (VA) imaging.
* To demonstrate and evaluate the capability of VA imaging in detecting microcalcifications and lesions inside the human breast.

OUTLINE: Participants undergo vibro-acoustography (VA) imaging of the breast using ultrasonography over 90 minutes. Participants may also undergo further imaging using clinical ultrasonography.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets one of the following criteria:

  * Healthy participant
  * Proven microcalcifications and/or lesions in the breast
* Hormone status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified
* Not pregnant or nursing
* No condition that does not allow proper use of study imaging devices

PRIOR CONCURRENT THERAPY:

* Not specified
Intervention Development for Syndemics Among PWH in SA

In South Africa, the country with the highest HIV prevalence (19%), co-occurring problems such as depression, post-traumatic stress, and food insecurity interact to enhance one another (i.e., syndemic problems) and are associated with worse HIV outcomes such as worse antiretroviral therapy (ART) adherence and worse viral load. This study proposes to: 1) explore how syndemic problems work together to make health worse for people with HIV (PWH) and explore what people think about a potential treatment; 2) develop a treatment to address syndemic problems and improve ART adherence (CBT-SA); 3a) assess whether people are willing to receive the CBT-SA we it can actually be done; and 3b) identify factors that make it easier or more difficult to receive CBT-SA.

South Africa (SA) has a generalized HIV epidemic, and the highest HIV prevalence rate (19%). Psychosocial (e.g., depression, post-traumatic stress) and structural problems (e.g., food insecurity) are associated with worse antiretroviral therapy (ART) adherence and higher viral load. Depression, post-traumatic stress, and food insecurity are also highly comorbid and are thought to interact synergistically to confer greater risk for worse HIV outcomes (i.e., syndemic problems). The proposed specific aims are to: 1) explore the complex interrelationships between food insecurity, depression, and post-traumatic stress, as they relate to engagement in HIV care, and explore attitudes to potential intervention components; 2) develop a multilevel intervention to address syndemic problems and improve adherence (CBT-SA) and conduct an iterative proof-of-concept pilot trial use syndemic theory; 3a) assess the feasibility and acceptability of CBT-SA in a pilot RCT; and 3b) identify barriers and facilitators of CBT-SA engagement among PWH and uptake among care providers and other key local partners to inform a future hybrid effectiveness/implementation R01 trial. If successful, this intervention would be further tested for effectiveness and implementation in a future application.

Eligibility Criteria:
Inclusion Criteria:

1. Patient receiving HIV care in Khayelitsha (confirmed by medical record)
2. Currently prescribed TDF-based ART, with recent difficulties with ART adherence (self-reported in past 30 days / confirmed by pharmacy refill data)
3. Mild, moderate, or severe food insecurity (measured by HFIAS categories) AND ≥1 of the following:

   * Clinically significant depressive symptoms (CES-D ≥ 16)
   * Clinically significant post-traumatic stress symptoms (SPAN ≥ 5)
4. 18 years of age or older

Exclusion Criteria:

1. Unable or unwilling to provide informed consent
2. In the past year: received CBT for depression or PTSD, or received supplemental food parcels or nutritional counseling
3. Current untreated or undertreated serious mental health issue that would interfere with participation
Muco Smartphone Exacerbation

Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity. Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present health costs burden leading to important physical psychological and social impact. Preventing exacerbation and early detection of these exacerbations may decrease intensity and freqauency of exacerbation leading to increase clinical status and QoLwith a decreased health cost.

Patients actually follow in CRCM track exacerbations when visits out patient clinic and during phone call. If patients did not call or did not present regularly to out patient clinic, exacerbation detection came later and so increasde the burden and therapeutic pressure.

The objective of our study is to identify earlier the potential exacerbations and so decreased the health costs and increased the patient's QoL. Forthis purpose we propose to use modern technologiessuch as smartphone in order to create alert when patients report weekly health satatus. We will compra patients randomize in control group with standart follow-up to patients randomize in the smartphone group.Moreover we will study the compliance and satisfactory degree of the use of this device in the interventional arm.

Exacerbation in cystic fibrosis play an important role in terms of mortality and morbidity. Exacerbation frequencies is relatedto FEV1 decline and mortality. There is a relationship between exacerbation frequency and QoLdeterioration. Moreover exacerbation treatments present health costs burden leading to important physical psychological and social impact. Preventing exacerbation and early detection of these exacerbations may decrease intensity and freqauency of exacerbation leading to increase clinical status and QoLwith a decreased health cost.

Eligibility Criteria:
Inclusion criteria:

* CF diagnosis
* Patient able to receive phone call
* Patient who use regulary a smartphone
* age from 14 to 25
* Patients with at least 2 exacerbations before the entry.
* Stable patient at V1

Exclusion criteria:

* Patients who are include in an interventional study
* Patient who is not able to read French language
* Patients with psychological disorder
A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Sitagliptin When Given Together to Healthy Subjects

The purpose of the study is to evaluate pharmacokinetics, pharmacodynamics and safety following the administration of ASP1941 and sitagliptin in single and multiple doses.

All subjects will be enrolled at one center and confined to the unit for up to 17 days. Subjects will be dosed in the fasting state in one of the four groups.

Eligibility Criteria:
Inclusion Criteria:

* The subject weighs at least 50 kg, and has a body mass index (BMI) of 18 to 32 kg/m2 inclusive
* The subject's 12-lead electrocardiogram (ECG) results are normal
* The female subject must be at least two years postmenopausal, surgically sterile or practicing effective birth control and not pregnant or lactating
* The male or female subject agrees to practice highly effective birth control from Screening until 7 days post last dose

Exclusion Criteria:

* The subject has a history or evidence of any clinically significant cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
* The subject has evidence of renal insufficiency (serum creatinine ≥ 1.5 in men and ≥ 1.3 in women)
* The subject has a history of cholelithiasis or acute pancreatitis
* The subject has any condition possibly affecting drug absorption (e.g., gastrectomy)
* The subject has history of consuming more than 14 units of alcoholic beverages per week within last 6 months or has a history of alcoholism or drug/chemical/substance abuse within past 2 years or the subject tests positive for alcohol or drugs of abuse
* The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check-in
* The subject has a supine mean systolic blood pressure \<90 or \>160 mm/Hg and a mean diastolic blood pressure \<50 or \>90, or pulse rate higher than 100 beats per min (bpm)
* The subject has a 12-lead ECG demonstrating QTcF \>470 msec (female) or \>450 msec (male)
* The subject is known positive for human immunodeficiency virus (HIV) antibody
* The subject has a positive test for tuberculosis (TB), hepatitis C antibody, or positive for hepatitis B surface antigen (HGsAg)
* The subject has used prescription or non-prescription drugs within 14 days or 5 half-lives (whichever is longer) or complementary and alternative medicines (CAM) within 14 days prior to study drug administration (excluding oral contraceptives, hormone replacement therapy \[HRT\], and acetaminophen)
* The subject has been vaccinated within the last 7 days
* The subject has had any significant blood loss, donated one unit (450 mL) or blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Spondyloarthritis

Biological therapies should be considered in patients with high disease activity despite nonsteroid antiinflammatory drug treatment. The first option among biological therapies is anti-Tumor Necrosis Factor (anti-TNF) drugs. In recent years, anti-TNF treatments have shown that clinical and ultrasonographic enthesitis may improve as well as disease activity, quality of life and acute phase reactants. In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.


Eligibility Criteria:
Inclusion Criteria:

* Spondyloarthritis patients were diagnosed according to 2009 Assessment of Spondyloarthritis International Society (ASAS) criteria

Exclusion Criteria:

* Severe cardiovascular and respiratory diseases,
* Severe liver and kidney failure,
* Pregnancy and lactation,
* Active infection,
* Malignancy,
* Demyelinating diseases,
* Systemic lupus erythematosus,
* History of knee, elbow, foot and ankle surgery,
* Fluoroquinolone, retinoid and fluoride use,
* Local corticosteroid injection at the examination sites within the six weeks before evaluation
* Peripheral neuropathy
Volume Versus Pressure Ventilation on Lung Atelectasis

This prospective randomized comparative study, to assess post-operative lung atelectasis by comparing calculated lung score using ultrasound between pediatric patients intubated with LMA (laryngeal mask airway) under volume versus pressure controlled modes of ventilation.

The initial US scanning will be done prior to the induction of anesthesia. Induction of anesthesia using 4% sevoflurane. Adequate size LMA will be inserted after adequate depth of anesthesia adjusted.

Group A (n=25): will receive pressure-controlled ventilation (PCV). Group B (n=25): will receive volume-controlled ventilation (VCV).

US scanning and Arterial blood gases at the following:

* T1(After maintenance of anesthesia).
* T2 (One minute after applying groin bandage and before extubation).
* T3 (10 minutes after extubation and resumption of adequate regular breathing).
* T4 (30 min post extubation).

Eligibility Criteria:
Inclusion Criteria:

Pediatric patients undergoing cardiac catheterization procedures. Age from 2 years to 6 years of both sexes.

Exclusion Criteria:

* Lung score at different times.
* Age \&lt;2 years and \&gt;6 years.
* Preoperative mechanical ventilation.
* Heart failure (any inotropic support infusion).
* Patients with any lung diseases( acute respiratory disease, pulmonary or lung
* diseases).
* Lung consolidation score ≥ 2 before insertion of LMA.
* Any contraindication for LMA insertion (risk for aspiration, and/or airway
* obstruction below the larynx.)
* Procedures exceeding 120 mins duration.
Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension

To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years;
* IOP=16-30mmHg
* OH or OAG with visual filed abnormality:

  1. ≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p \<5% on the prepapillary diameter plot, one of which must have p \<1%,
  2. Glaucoma Hemifield Test outside normal limits,
  3. Corrected Pattern Standard Deviation with p \<5%

Exclusion Criteria:

* Previous damage of anterior chamber angle;
* ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) \<1.0;
* contact lens wearer;
* severe central field loss;
* uncontrolled cardiovascular, hepatic or renal disease;
* any medication within past 1 month.
Sun Protection of Kidney Transplant Recipients

This study is being done to evaluate the effectiveness of a Sun Protection Strategies internet-based program for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at increased risk of developing a sunburn as well a skin cancer, the program will help people learn how to practice effective sun protection for their condition.

Cognitive interviews about an internet-based sun protection strategies program will be performed with up to 45 kidney transplant recipients (KTRs) who have participated in past surveys. A second group of 150 KTRs will be asked to evaluate the internet-based module for the effectiveness of information. A third group of 12 KTRs will be asked to evaluate the internet-based module for usability. A fourth group of 160 KTRs will be asked to take part in a randomized controlled trial evaluating the fully developed internet-based sun protection strategies program.

Kidney transplant recipients (KTRs) are at risk to develop skin cancer. Adequate sun protection after transplantation can reduce the risk of developing skin cancer. In 2006, the National Kidney Foundation (NKF) found that sun protection education delivery and content varied among transplantation centers. Clinicians rarely knew when to initiate education about skin cancer risks and prevention including timing and scope, and rarely demonstrated understanding of the importance of reminders for and repeated education of patients. (National Kidney Foundation 2006) The NKF supported standard, formal, well timed skin cancer prevention information and sending reminders to KTRs at the beginning of summer.

Aims:

1. To explore culturally sensitive use of terms describing ethnic cultural perceptions of sun burning, pigment darkening after sun exposure and description of skin color by the amount of photoprotective pigment in the skin.
2. To pilot test the internet-based sun protection brochure with English speaking KTRs representing 3 ethnic groups: White, Black and Hispanic.
3. To explore understanding of the importance of sun protection and the KTRs' confidence in their being able to practice sun protection.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of kidney transplantation within the last 5 years
* Speaks English
* Can see to read
* Lives in the greater Chicago area and can attend a cognitive interview session
* 18-85 years old

Exclusion Criteria:

* Unable to speak English
* Cognitive impairment or neurologic disease
* Dementia or insufficient cognitive skills to follow instructions provided at a sixth grade language level
* Has had a skin cancer
EVALUATION OF EFFICACY OF SAMEUP IN SUBJECTS WITH DEPRESSION SYMPTOMS: A RANDOMIZED STUDY

This study is planned to assess the efficacy of SAMEUp versus placebo after six weeks of treatment in subjects characterized by depression symptoms according to ICD-10 (International Classification of Diseases - 10th revision) diagnostic criteria and confirmed by mean of Zung's Self-Rating Depression Scale.

Depression is a common condition of low mood and aversion to activity that can affect a person's thoughts, behaviour, tendencies, feelings, and sense of well-being.

Several literature findings suggest that an oral combination of the two food supplements SAMe (S-adenosyl-L-methionine) and probiotic Lactobacillus plantarum might be favourable in relieving some of symptoms of depression, particularly in the mild to moderate forms of this condition. This double blind placebo controlled clinical study aims to evaluate this hypothesis. In particular, the primary objective is to assess, versus placebo, the efficacy of SAMEUp in improving the overall symptomology of depression after 6 weeks of treatment. Subjects with mild to moderate depression were identified according to ICD-10 diagnostic criteria and confirmed by mean of Zung's Self-Rating Depression Scale.

SAMEUp, the investigational food supplement, is an oral formulation (tablet) containing S-adenosyl methionine (SAMe) 200 mg and Lactobacillus plantarum HEAL9 1x109 CFU, already notified to the Ministry of Health as food supplement.

Placebo is an oral formulation of inert tablet. Placebo and SAMEUp are indistinguishable.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent, personally signed and dated by the subject.
2. Males and females, aging 18-60 years old (limits included).
3. Diagnosis of mild to moderate recurrent depressive disorder according to the ICD-10 / F33 criteria (World Health Organization, 2004).
4. Subject who, having completed the Z-SDS depression questionnaire, has a raw score between 41 and 55 (including limits).
5. Subject able to comprehend the full nature and purpose of the study, available to cooperate with the Investigator and to comply with the requirements of the entire study.

Exclusion Criteria:

1. Pregnant or breast-feeding woman.
2. Subject with one or more psychiatric disturbances, such as: alcoholism, substance abuse or dependency disorder, bipolar disorder, schizophrenia, or other personality disorder.
3. Subject with known or potential hypersensitivity to any ingredient in the study product.
4. Subject in treatment with psycholeptic drug, such as: antipsychotics, anxiolytics, hypnotics and sedatives.
5. Subject who has taken during the 2 weeks prior to inclusion, who is currently taking or plans to take other orally administered food supplements except the study product. Only multivitamins, salts and trace elements are accepted
Prolift Versus IVS for Pelvic Floor Prolapse

* Women who underwent mesh or sling procedures to correct pelvic organ prolapse will be enrolled.
* Their data will be collected from the files.
* Comparison between two groups will be carried our: Those who underwent a posterior IVS and those who underwent posterior prolift procedure.
* The data will be obtained by questionaires by a telephone interview by a physician who did not participate in the surgery.
* Follow-up physical examination data will also be obtained.


Eligibility Criteria:
Inclusion Criteria:

* Women who previously underwent surgery for pelvic floor prolapse at least a year before

Exclusion Criteria:

* Women who did not have surgery for pelvic floor prolapse
Replicative Stress in Hair Follicle Stem Cells and Pathogeny of Hidradenitis Suppurativa

Hidradenitis Suppurativa is a recurrent chronic inflammatory follicular occlusive disease affecting hair follicles. HS is notoriously difficult and challenging to treat with a high morbidity impact and could be classified as an unmet medical need with no efficient therapeutic options.

Objective:

Investigators previously showed that Outer Root Sheath Cells (ORS) isolated from hair follicle of HS patients (HS-ORS) have a pro-inflammatory phenotype and secrete spontaneously IP-10 and RANTES. To identify the mechanisms involved in the pro-inflammatory phenotype of HS-ORS, investigators performed a transcriptomic analysis in healthy and HS patients. This revealed: (i) an IFN signature, (i) a dysregulation of genes involved in cell proliferation and differentiation, and (iii) an upregulation of DNA damage response and cell cycle G2/M checkpoint pathways in HS-ORS. These findings support the notion that, in HS patients, a perturbation of HF-SC homeostasis leading to an increased proliferation induces a replicative stress and an accumulation of cytoplasmic ssDNA, stimulating IFN synthesis through IFI16-STING pathway. Interestingly, replicative stress in ORS were present in some but not all patients with Hidradenitis Suppurativa. The goal of study is to determine replicative stress in ORS in a large cohort of HS patients.

Method Patients will be enrolled in the Mondor Dermatology department, during routine care. A dermatologist will check all inclusion and exclusion criteria with the technical support of a research technician of the Henri Mondor Clinical Investigation Center. Medical history, clinical data, comorbidities and concomitant therapies will be prospectively recorded in a dedicated case report form. Skin biopsies will be performed in perilesional zone rich in hair follicles. mRNA will be extracted from freshly isolated hair follicle cells and some slides will be prepared and stored at -80°C to perform immunohistochemistry analysis on freshly isolated hair follicle cells. PBMC and serum will be collected.

All these biological samples will allow us to quantify the replicative stress in HS-ORS of each patient, and to quantify several cytokine of interest : IFN de type 1, IL-17, IL-6, TNF-α, IL-10

This study will allow investigators to evaluate the rate of patients with replicative stress in hair follicle stem cells in Hidradenitis Suppurativa. The investigator will also determine whether HF-SC replication stress correlates with clinical characteristics and/or with clinical course and/or comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the consultation of dermatology of Henri Mondor Hospital
* Diagnosis of Hidradenitis Suppurativa
* Age\> 18 y.o.
* Affiliation to a social security system

Exclusion Criteria:

* Patient under tutorship or curatorship
* Breastfeeding or pregnant women
* Refusal to sign the consent letter
* Patients benefiting from State Medical Aid
Effect of Peripheral Electrical Stimulation (PES) on Brain Response to Glucose Stimuli

The aims of this study are twofold: (1) to develop an innovative approach for studying brain glucose metabolism using functional diffusion weighted imaging (DWI) and BOLD fMRI in humans; (2) to evaluate the effect of short peripheral electrical stimulation (PES) treatment on brain and brain-stem targets, associated with control of food intake and energy expenditure, in response to glucose stimuli, in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age 18-65 years old.
* Body mass index 18 to 25 kg/m2
* Capable of giving informed consent

Exclusion Criteria:

* Pregnancy, or nursing
* Permanent pacemakers
* Metal prosthesis
* Skin disease
* Claustrophobia
* History of neurological disorders