cyrilzakka/clinical-trials huggingface dataset:
Education Program to Promote Female Condom Use

The female condom offers women a potentially important option for HIV prevention. This study will develop and evaluate a health education program to increase female condom use among ethnically diverse women.

AIDS incidence among women has grown at alarming rates since 1985. Heterosexual contact is now the greatest risk for HIV infection in women. Women in the United States urgently need more options to protect themselves against HIV. Nonetheless, limited prevention efforts have targeted women. The female condom is a potentially important option for HIV prevention in women. However, little research has been conducted to identify effective approaches to promote the female condom as the only female-controlled barrier method available to date. This study will develop a theoretically and empirically based intervention to increase female condom use among ethnically diverse women who engage in multiple sexual partnerships.

The proposed female condom skills training intervention applies social cognitive theory. It also incorporates our extensive previous research that examined female condom acceptability and identified the attitudinal, interpersonal, and sociocultural factors affecting female condom use. The intervention consists of four sessions: 1) individual safer sex education and condom use skills training; 2) group discussion of barriers to female condom use; 3) group condom negotiation skills training; and 4) individual condom use counseling. The efficacy of the intervention will be assessed by comparing it to a control condition intervention that focuses on women's general health issues unrelated to HIV/AIDS. The control condition intervention has four sessions: 1) individual health education; 2) group discussion of women's health problems and related risk behaviors; 3) group discussion of healthy living; and 4) individual health risk reduction counseling.

This study will use a randomized clinical trial design. Study participants will be randomly assigned to one of two conditions: female condom skills training or women's general health promotion. All participants will be interviewed at study entry, 3 months, and 6 months. Attitudinal, psychosexual, and behavioral data will be collected to evaluate the intervention.

Eligibility Criteria:
Inclusion Criteria

* African American, Asian American, Latina, or White
* Two or more male sexual partners in the year prior to study entry
* English speaking

Exclusion Criteria

* Commercial sex workers
* Planning to move within 6 months of study entry
* Allergic to polyurethane, latex, or lubricants
Effect of the Consumption of Alcohol-free Beers With Different Carbohydrates Composition on Postprandial Metabolic Response

The overall objective of this study is to explore the glycemic index and glycemic load induced by an alcohol-free beer with modified composition (including almost full fermentation of carbohydrates and the addition of isomaltulose and a resistant maltodextrin), as well as its postprandial metabolic response, compared to the effect induced by: a) an alcohol-free beer with a usual composition; b) an alcohol-free beer with modified composition (including almost full fermentation of carbohydrates and the addition of a resistant maltodextrin). This study includes two cross-over sub-studies recruiting healthy participants. In the first one, 10 healthy volunteers receive 25 g of carbohydrates coming from: regular alcohol-free beer (RB), alcohol-free beer with almost completely eliminated maltose and enriched with isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB), alcohol-free beer with the same maltose removal enriched with resistant maltodextrin (2.0 g/100 mL) (MB) and glucose solution. In the second study, 20 healthy volunteers are provided with 50 g of carbohydrates from white bread and water and the same meal plus 14.3 g of carbohydrates coming from: RB, IMB, MB and extra white bread. Blood is sampled at baseline and for 2 h, every 15 min, after ingestion.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 and 27.5 kg/m2.

Exclusion Criteria:

* Presence of cardiometabolic pathology such as dyslipemia (total cholesterol \> 200 mg/dL and/or triglycerides \> 150 mg/dL, and/or taking lipid-lowering drugs), prediabetes or type 1 or 2 diabetes mellitus (glucose ≥ 100 mg/dL and/or glycosylated hemoglobin ≥ 5.7% and/or taking hypoglycemic drugs) or high blood pressure without drug treatment.
* Presence of other chronic pathologies that could interfere with the results of the study such as cardiovascular disease, kidney disease, thyroid disease or liver disease.
* Presence of intestinal malabsorption syndromes and/or presence of Chron disease or ulcerative colitis.
* Use of drugs that may interfere with lipid and/or glycidic metabolism.
* Presence of some analytical alteration that could interfere with the results of the study.
* Increased or decreased body weight of ≥ 5 kg in the last 6 months.
* Gluten intolerance.
* Regular intake of functional foods such as phytosterols or red rice yeast, which have a significant effect on lipid or glycidic metabolism, in the last 6 weeks.
* Intake of vitamin supplements.
* Hormone replacement therapy.
Efficacy of Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Obesity: A Randomized Clinical Trial

The aim of this study is to observe the efficacy of electrical vestibular nerve stimulation in the management of obesity.

Allocation: Active device (participants act as their own self-control) Endpoint classification: Efficacy Study. The study provides further evidence for the efficacy of electrical vestibular nerve stimulation in the management of obesity.


Eligibility Criteria:
Inclusion Criteria:

* BMI 30 to 40 kg/m2
* Aged above 18 years

Exclusion Criteria:

* Current use of any medications or therapy including use of oral contraceptives
* Use of dietary supplements known to affect the BMI
* Ear problems (assessed during physical examination)
* Any severe complications
* Unwilling participants
Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ

Evaluation of the sexual quality of life of women who had a sub-urethral sling several years ago, using a recently validated questionnaire: the PPSSQ (Pelvi-Perineal Surgery Sexuality Questionnaire).

This questionnaire is specifically oriented for women who have undergone surgery for stress urinary incontinence or prolapse. It contains questions specific to post-surgical issues that are not present in other sexual quality of life questionnaires. The questionnaire will also be administered to a group of control women who have not had suburethral sling surgery in order to compare their responses to those of women who have had surgery.

The hypothesis is that the placement of a suburethral sling for stress urinary incontinence increases the quality of sexual life of the women.


Eligibility Criteria:
Inclusion Criteria:

Patient group

* Women who have received a suburethral sling at CHUGA in the gynecology or urology departments between January 2015 and June 2020.
* Women who agreed to complete the PPSSQ

Healthy volunteers group

* Adult women matched on age and menopausal status to the patient group
* Women who have never undergone surgery for stress urinary incontinence by placing a sub-urethral tape.
* Women who agreed to complete the PPSSQ

Exclusion Criteria:

Patient group

* Tape removal.
* Death since surgery.
* Factors that make it impossible to understand the questionnaires: neurological or psychiatric pathology that limits the understanding of the questions, lack of mastery of the French language, illiteracy.
* Absence of perineal sensation.
* Persons referred to in articles L1121-5 to L1121-8 of the CSP.

Healthy volunteers group

* Factors that make it impossible to understand the questionnaires: neurological or psychiatric pathology that limits the understanding of the questions, lack of mastery of the French language, illiteracy.
* Absence of perineal sensation.
* Persons referred to in articles L1121-5 to L1121-8 of the CSP.
Microcirculation in Cardiac Surgery

The purpose of this study is to determine whether cardiopulmonary bypass affects mesenteric microcirculatory function, using sublingual evaluation, in cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years old
* aortic valvular disease needing aortic valve replacement

Exclusion Criteria:

* Age\<18 years old
* emergent cardiac surgery
* other cardiac surgery
Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies

This project will optimise the management of chemotherapy-induced nausea and vomiting, with improvements in nausea and vomiting scores, quality of life and appetite expected in participants benefiting from the intervention. In all cases, the use of complementary methods is recommended and improves the management of people with cancer because they offer a person-centred approach.

The aim is to evaluate the efficacy of inhalation of a mixture of ginger and lemon Essential Oils (EO) versus placebo in addition to conventional antiemetic treatments on the intensity of chemo-induced nausea during the acute phase D1 (H24) of its onset in patients with C1 haematological malignancies.

This multicentre study will be carried out in 5 establishments (haematology and oncology care sectors), which represents a very high potential for inclusion.

In addition, the investigator expect a very high acceptance rate for this study. In fact, in the context of CINV, this care strategy may meet a patient's expectation of symptoms (nausea, vomiting) that they find difficult to manage. Finally, it is known that patients in these care sectors are very keen on supportive care to improve their quality of life, so this is a potentially very interesting opportunity without any particular risk that is offered to participants in this study.

A nurse and a doctor with a postgraduate diploma in aromatherapy are coordinating the team, with the support of a nurse trained in evidence-based practice research methodology. Institutional procedures drawn up by the team at Limoges University Hospital describe the general procedure for using aromatherapy in a scientific and safe way, the protocols that can be used to describe the operating methods, the traceability of the manufacture of the mixtures and their administration, and the evaluation of their effectiveness. Supporting documents, an information note and a monitoring sheet have been created and are being used.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years,
* Chemo-naive patients at inclusion,
* Patients with haematological malignancies treated treated with chemotherapy,
* Patients physically and mentally able to use the aromastick,
* Patients who speak, read and write French,
* Patients who have given signed consent,
* Patients with social security cover.

Exclusion Criteria:

* Asthmatic patients.
* Patients with anosmia.
* Patients allergic to EO, lemon or ginger.
* Patients who have already received aromatherapy to treat chemotherapy-induced nausea and vomiting,
* Patients practising herbal medicine or acupuncture,
* Pregnant and breast-feeding women,
* Patients under guardianship, tutorship or curatorship,
* Patients taking part in interventional studies involving antiemetic drugs or nutritional products,
* Patients who have already had cancer.
THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence

The purpose of this study is to pilot and refine an online behavioral intervention based on Positive Affect Training (PAT) that aims to increase positive emotional attitudes and decrease negative emotional attitudes toward endocrine therapy (ET, i.e., anti-hormonal medication) and to increase positive affect and decrease negative affect more generally, among post-treatment breast cancer survivors who are prescribed ET to prevent recurrence of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* hormone receptor-positive breast cancer stages 0-3
* have finished primary treatment (chemotherapy/radiation/surgery)
* are prescribed endocrine therapy (ET) currently or within the last two years
* score above specified cut off (range, 0-10) on any of three questions:

  1. How upset are you by having to take anti-hormonal therapy
  2. How bothered are you by the side effects?
  3. How difficult is it for you to take your anti-hormonal medication every day?
* have internet access to complete online assessments and intervention components or agree to use and return a study wifi-activated iPad.

Exclusion Criteria:

* metastatic disease
* Individuals who are unable to interact with the intervention as needed. This includes those who are extremely visually impaired to the degree that they cannot see the screen and interact as required and individuals who cannot read and/or write in English. This is due to the nature of the intervention itself. If a participant is unable to interact with THRIVE as required, they are unlikely to benefit from the intervention or offer insightful feedback that can be used in refining the program.
The Objectives of the Cartilage Repair Registry is to Report Long Term Efficacy and Safety of Cartilage Repair Procedures in Registry Patients

The objectives of the Cartilage Repair Registry is to report the long term efficacy and safety of cartilage repair procedures in Registry patients.


Eligibility Criteria:
Inclusion Criteria:

* All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort

Exclusion Criteria:

* All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort
Submacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm

Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial macroanuerysms.


Eligibility Criteria:
Inclusion Criteria:

* The patients with sub macular hemorrhage associated with ruptured retinal arterial macro aneurysms

Exclusion Criteria:

* The eyes with preretinal or intraretinal hemorrhage at the fovea
* The patients with follow-up less than 3 months
OMNIA Efficacy on Body Fat Mass Reduction

The purpose of this clinical trial is to evaluate the safety and efficacy of a food supplement OMNIA compared to a placebo in reducing the body fat mass in 70 overweight subjects during 12 weeks treatment.

Overweight and obesity represent a serious public health issue. These conditions are characterized by an abnormal or excessive accumulation of body fat mass and they are related to an increase risk of developing chronic diseases such as cardiovascular, diabetes, arthrosis and certain kind of cancer (breast; colon). It's thus necessary to find new products able to counteract both overweight and obesity.

Omnia is a food supplement based on a Phaseolus vulgaris extract. It has pancreatic amylase inhibition properties.

In the following clinical trial, OMNIA will be administrated to a group of overweight subjects in order to evaluate its efficacy on reducing the body fat mass. Its action will be compared to a placebo administered to a second group of overweight volunteers with the same modalities as OMNIA.

Eligibility Criteria:
Inclusion Criteria:

* 25≤ BMI\<30 kg/m2
* excess of fat mass
* food habits : 3 meals a day and a glucides intake equivalent to at least 40% of daily energy (i.e.: glucides intake at each meal)
* Able to give a written or verbal informed consent
* Affiliated or beneficiary of social security

Exclusion Criteria:

* Weight loss/gain \> 2kg within the preselection period (2 weeks)
* Abnormal blood results at V0
* Physical activity (sport; lifestyle) modification planned or ongoing during the trial
* Severe pathologies/disorders (bulimia; anorexia; diabetes; cancer...) emerging
* Pregnancy during the study
* Consent withdrawal
* Allergy to Omnia
* observance \<60%
* Investigator or promotor decision
Home-based Leg Heat Therapy

The objective of this study is to evaluate the benefits of participating for 8 weeks in a home-based daily treatment with heat therapy (HT) or a thermoneutral control intervention, as assessed by vascular function, walking tolerance and quality of life.

Heat therapy (HT) is an emerging non-invasive approach that has been shown to enhance vascular function of the leg in old individuals. The objective of this randomized, controlled study is to evaluate the benefits of participating for 8 weeks in a home-based daily treatment with heat therapy (HT) or a thermoneutral control intervention, as assessed by vascular function, walking tolerance and quality of life. The central hypothesis of this study, based on preliminary data, is that exposure to HT will enhance the oxygenation of calf muscles during exercise and as a result, the onset of pain will be delayed and walking performance will be enhanced. The duration (8 weeks) was chosen based on the recent report of Brunt and co-workers that the improvement in endothelial function promoted by repeat HT in sedentary individuals peaks at 8 weeks following the onset of treatment. Heat Therapy will be applied daily for 90 minutes using water-circulating 'pants' connected to a water pump. Outcomes will be assessed at the halfway point (end of week 4), at the completion of the intervention (end of week 8) and 4 weeks after the end of the intervention (week 12).

Eligibility Criteria:
Inclusion Criteria:

* Men and women with a stable symptomatic PAD for ≥6 months
* Ankle brachial index \<0.9 in at least one leg
* Age between 40 and 80 years

Exclusion Criteria:

* Uncontrolled Diabetes (HbA1C \> 8.5 measured within 3 months prior to date of consent)
* Wheelchair bound
* Use of a walking aid (i.e. cane, crutches, walker, motorized chair)
* Critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or tissue loss
* Impaired thermal sensation in the legs
* Exercise-limiting comorbidity
* Chronic Heart Failure stages C and stage D (Stage C: structural heart disease is present and symptoms have occurred; Stage D: presence of advanced heart disease with continued heart failure symptoms requiring aggressive medical therapy)
* Morbid obesity BMI \> 35 or unable to fit into water-circulating pants
* Open wounds or ulcers on the extremity
* Prior amputation
* Lower extremity revascularization, major orthopedic surgery, cardiovascular event, or coronary revascularization in the previous three months
* Planned revascularization or major surgery during the next six months
* Plans to change medical therapy during the duration of the study
* Active treatment for cancer
* Chronic kidney disease (eGFR \<30 by MDRD or Mayo or Cockcroft-Gault formula).
* HIV positive, active HBV or HCV disease.
* Presence of any clinical condition that makes the patient not suitable to participate in the trial.
* Unable to walk on the treadmill
Serum Tryptase Concentration During General Anaesthesia With Rocuronium

Rocuronium is a aminosteroid structured, non-depolarizing neuromuscular blocking agents (NMB). Epidemiological data presents that the frequency of hypersensitivity reactions caused by rocuronium have been increased. Determinations of serum tryptase concentrations are interdisciplinary recommended in diagnosis of its adverse reactions. No studies have been performed to explain specific role of rocuronium doses on serum tryptase values. The aim of this study was to investigate the potential effect of rocuronium on serum tryptase concentrations.

The greatest risk of hypersensitivity occurs during anesthesia for female patients and it is connected with the induction phase using skeletal muscle relaxants . Epidemiological data presents that the frequency of hypersensitivity reactions caused by rocuronium have been increased. Due to the multiple advantages reports of triggering allergic or hypersensitivity reactions caused by rocuronium create doubts about the safety of application .

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2, no allergy and perioperative hypersensitivity reactions during anaesthesia

Exclusion Criteria:

* steroid therapy, allergy in medical history, mastocytosis
EngageRx With Integrated Self-Measurement of Blood Pressure

This pilot study will support use of EngageRx_SMBP for 70 patients in the UCSF General Internal Medicine practice. The goals of the pilot will be to assess usability and satisfaction of both patients and clinicians, and to describe BP-related process metrics and outcomes including time to intensification of BP medications and/or BP control.

EngageRx is a programmable clinical decision support app that clinicians can access within the context of their electronic health record (EHR), and it can be connected with other technologies. We are integrating EngageRx with CareSimple, a company that provides a cellular-enabled BP device that patients can use for SMBP. CareSimple devices are FDA-cleared, can be shipped directly to patients, used by patients right out of the box (after installing batteries), and then deliver the SMBP measurements directly to the CareSimple cloud platform. There is no requirement to "sync" the device, and no need for patients to have a smartphone or set up an account or sign into anything. CareSimple supports a dashboard and portal that allows authorized users to sign in and access measurements for a patient, but this amounts to another barrier for clinicians to access the measurements; our integration with EngageRx will 1) allow clinicians to initiate SMBP monitoring for a patient with the click of a button (after confirming their shipping address and preferred language); 2) automatically register the patient in the CareSimple system, which triggers CareSimple to mail the patient the BP monitor device with instructions; and 3) automatically push the CareSimple SMBP measurements to EngageRx so they are available the next time the clinician opens EngageRx. The SMBP measurements will be used with EngageRx's internal algorithm, along with office BP measurements, to recommend BP management decisions to clinicians. We believe this integrated system, which we will refer to as EngageRx_SMBP, will make SMBP easy for clinicians and patients. We would like to determine if this system is truly easy to use for clinicians and providers, and whether it appears to facilitate the BP-related processes of care required for controlling hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (18+ years old) with uncontrolled BP in an office visit
* Lowest SBP\>140 or lowest DBP\>90 during the visit at one of the Mt. Zion General Internal Medicine practices
* Speaks English or Spanish

Exclusion Criteria:

* If patient is unlikely to be able to use a home BP monitor
* Cannot understand the verbal consent