cyrilzakka/clinical-trials huggingface dataset:
Plant Versus Animal Dietary Protein and the Effect on Proteinuria

The purpose of this study is to investigate if a diet high in plant protein improves kidney function in patients with kidney insufficiency and diabetes and/or hypertension and/or glomerulonephritis. The study is a non-blinded, randomized, controlled, cross-over-design with two intervention periods of each 14 days. Between the two interventions periods there is a washout period of 14 days. The participants are randomized to start with an individualized diet plan containing either high amounts of animal protein or high amounts of plant protein.

The purpose of this study is to investigate if a diet high in protein (2,0 g/kg/d) of plant origin, decreases proteinuria amongst patients with diabetes, hypertension and/or glomerulonephritis with presence of micro- or mild macro albuminuria, compared to a diet high in protein of animal origin.

Kidney insufficiency is associated with increased morbidity and mortality, decreased quality of life and large financial costs for the health care system.

Evidence suggest that the source of protein may inflect the progression of the kidney disease where soy protein has shown a positive effect on estimated glomerular filtration rate and proteinuria amongst both diabetic and non-diabetic patients with nephropathy.

The study design is a 6-week, non-blinded cluster randomized, controlled, cross-over study with two intervention periods of each 14 days. Between interventions there is a washout period of 14 days. The participants are randomized to follow either a diet high in plant protein (HPPD) or a diet high in animal protein (HAPD). The diet plans are individualized to accommodate the participants energy requirements. Given the high amount of protein in the diets they are supplemented with either soy protein powder or beef protein powder. To measure primary and secondary endpoint, the participants are instructed to collect two times 24-hour urine sample at the first baseline, after 14 days and after 42 days. Blood samples are collected at the first baseline, after 14 days, at the second baseline and after 42 days.

To gain enough statistical power a minimum of 16 participants should be included. To accommodate a drop-out rate of 25%, 20 participants should be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* UACR between 30 and 800 mg/g in minimum two spot urine samples.
* Estimated Glomerular Filtration Rate (eGFR) \>30 ml/min. eGFR must have been stabil over the past 6 months defined by a maximal fluctuation in eGFR of 10 ml/min.
* Minimum 30 years of age.
* Danish speaking and writing
* No changes in blood pressure medication for the past three months.

Exclusion Criteria:

* Vegetarianism or veganism
* Pregnancy
Study Evaluating Vaccine in Adults With HIV

The purpose of this study is to learn whether the study vaccine and adjuvants (drugs that are used to help improve immune responses) have an acceptable safety profile in treating individuals with HIV.

A second purpose of this study is to understand how the immune system responds to the study vaccine and adjuvants.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age diagnosed with HIV and on stable HAART for a minimum of six months
* CD4 T-cell count greater than and equal to 350/mm3 at screening
* No reported CD4 T-cell count less than 350/mm3 at any time before screening
* Viral load less than 50 copies/mL at screening and no viral load greater than 400 copies/mL for a minimum of six months prior to screening

Exclusion Criteria:

* Any chronic symptomatic infection other than HIV
* Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening
* Any malignancy that may require systemic therapy
* Use of any investigational treatment within six months before screening or planned during study enrollment, except for investigational retrovirals obtained through ACTG
Clinical Trial to Assess the Efficacy and Safety of EASYDEW MD REGEN Cream Containing Neopop-S.

The purpose of this clinical study is to evaluate the effect on skin regeneration after applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, to patients who have undergone picosure picosure laser skin treatment as needed.

This clinical study is a researcher-led randomized control group comparative clinical study that is conducted prospectively for one month after applying medical devices for clinical research.

The subjects are those who have undergone a picosure laser procedure for therapeutic purposes on the skin tissue of the face or body, and a screening test is conducted after the subject (and/or legal representative) agrees in writing to participate in the clinical study.

The screening test results are evaluated, and subjects who meet the selection criteria and do not meet the exclusion criteria are registered in clinical research.

Participating subjects are randomly assigned to the control group and the study group using a random number table at a 5:5 ratio.

* Control group: 10 people without treatment
* Study Group: 10 People Applying EasyDu Regen MD Cream Clinical study subjects are randomly assigned to control and study groups. In the case of the study group, the Easy Dew Regen MD cream provided through prescription is applied twice a day (morning and evening) to the skin of the area where the picosure laser treatment has been performed and absorbed well. The control group is the non-chalant group. However, general moisturizers that were used at home rather than medical devices for one month after the procedure can be used, and they are applied twice a day (morning and evening) to the skin of the area where the laser treatment has been performed and absorbed well.

One month of clinical research medical device application will be observed, and subjects will regularly visit the research institution to evaluate its validity and safety during screening visits (Visit1), treatment (Visit2), 2 weeks after treatment (Visit3), and 1 month after treatment (Visit3) You will receive it.

Eligibility Criteria:
Inclusion Criteria:

* Those aged 19 to 65 who have undergone picosure laser treatment on facial and body skin tissues
* Decided to participate in this clinical study and signed a written informed consent the subject

Exclusion Criteria:

* Subjects with uncontrolled diabetes
* Subjects with uncontrolled hypertension and cardiovascular disease
* Subjects with hemorrhagic diseases such as hemophilia
* Immunosuppressants, corticosteroids, cytotoxic agents, and anticoagulants can affect the results Subjects who are or are scheduled to receive medication for an extended period of time
* Acute or chronic skin disease causes stage progression or active bacteria in the application area Who has a virus infection
* When the researcher's judgment determines that participation in the study is inappropriate (e.g. keloid constitution)
Evaluation of the Progression of Disease and Health-related Quality of Life in Patients With Pulmonary Hypertension: A Local Clinic-based Registry

Pulmonary Hypertension (PH) is a multifaceted disease and is associated with significant morbidity and mortality if untreated1. Diagnosing PH can be challenging and often delayed2. Multiple international registries included REVEAL3 and COMPERA4 have all demonstrated that diagnostic delay and suboptimal treatment prescription led poor 1 year-survival in patient with PH. In recent years, significant progress has been made in diagnosing, risk stratification, and treatment for patients with PH1. A dedicated PH service has been established in ambulatory clinic to streamline the management of these complex patients. This registry therefore aims to investigate the progression disease and its impact on the quality of life (QoL) of the patients who are managed at the dedicated PH clinic.

Pulmonary Hypertension (PH) is a multifaceted disease and is associated with significant morbidity and mortality if untreated1. Diagnosing PH can be challenging and often delayed2. Multiple international registries included REVEAL3 and COMPERA4 have all demonstrated that diagnostic delay and suboptimal treatment prescription led poor 1 year-survival in patient with PH. In recent years, significant progress has been made in diagnosing, risk stratification, and treatment for patients with PH1. A dedicated PH service has been established in ambulatory clinic to streamline the management of these complex patients. This registry therefore aims to investigate the progression disease and its impact on the quality of life (QoL) of the patients who are managed at the dedicated PH clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patients age \> 18 with echocardiographic confirmation of increased pulmonary pressure (eg. estimated RVSP \>40mmHg, evidence of RV dilatation etc), and no apparent reversible causes.
* Patients with reasonable pre-morbids and is able to attend ambulatory clinic.

Exclusion Criteria:

* Inability to provide valid consent by the patient or his legal guardian
CLINICAL INVESTIGATION for the EVALUATION of EFFICACY and SAFETY of TWO PRODUCTS for the TREATMENT of ONYCHOMYCOSIS

The efficacy and safety of ENRICHED (X92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients.

Subjects will be treated with either the test medical device (ENRICHED X92001591) or the reference product (Loceryl, 5% amorolfine) for a period of 9 months. The primary objective of the investigation will be increase of % of healthy nail surface versus baseline, as evaluated by a blinded investigator. Subjects will be followed up for a period of 9 months, with visits at D0 (baseline), D90 (month 3), D180 (month 6) and D270 (month 9).

Eligibility Criteria:
Inclusion Criteria:

* 1. Patient having given freely her/his informed, written consent. 2. Patient having a good general health. 3. Age: between 18 and 70 years; 4. Patient with superficial onychomycosis on at least one great toenail or fingernail (for at least 10% in each arm) or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \&lt;2/3 of the tablets).

  5. Patient with positive KOH staining. 6. Patient cooperative and aware of the products modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.

  7. Patient being psychologically able to understand information and to give their/his/her consent.

  8. Patient having stopped any systemic antifungal treatment since at least 6 months before screening and/or any topical antifungal treatment since at least 3 months before screening.

  9. Patient who agree to refrain from receiving pedicure/manicure, artificial nails and/or cosmetic nail varnish or other medication on the nail being treated for the entire study duration.

  10. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after study end.

Exclusion Criteria:

- 1. Pregnant, breastfeeding woman or woman planning a pregnancy during the study; 2. Patient considered by the investigator likely to be non-compliant with the protocol. 3. Patient enrolled in another clinical trial or which exclusion period is not over. 4. Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk; 5. Patient suffering from a severe or progressive disease (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology... 6. Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.

7. Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).
Low-level Laser Therapy in Genitourinary Symptoms of Menopause

The study will employ a prospective single-arm design involving menopausal women who present with genitourinary symptoms of menopause (GSM). Due to the preliminary nature of this study and the absence of a control group, the primary objective is to evaluate the feasibility and potential efficacy of low-level laser therapy in alleviating GSM in this population.

A convenience sample of menopausal women aged more or equal to 45 years will be recruited from the gynecology clinic in our hospital and its branches. Participants will undergo an initial screening to confirm the presence of genitourinary symptoms associated with menopause. Inclusion criteria will encompass women experiencing symptoms such as urinary incontinence, vaginal dryness, dyspareunia, and decreased sexual satisfaction. The exclusion criteria will be diagnosed with advanced pelvic organ prolapse (more or equal to stage 2 prolapse by pelvic organ prolapse quantification system).

All participants will receive low-level laser therapy (LLLT) as the intervention. LLLT sessions will be conducted once a week for eight weeks. The laser therapy will be administered by a trained healthcare professional using a standard protocol, targeting the genitourinary area. The laser device will emit low-energy laser light, which is hypothesized to stimulate tissue regeneration, improve blood circulation, and alleviate symptoms in the genitourinary region.

Baseline assessments will be conducted prior to the initiation of LLLT, including demographic data collection and validated outcome measures to evaluate GSM and quality of life. These measures may include the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), Female Sexual Function Index (FSFI), Vaginal Health Index (VHI), Incontinence Impact Questionnaire-7 (IIQ-7), Overactive Bladder Symptom Score (OABSS), Urogenital Distress Inventory-6 (UDI-6), Urgency Severity Scale (USS), King's Health Questionnaire (KHQ), and a urodynamic study with a 20-minute pad test. Follow-up assessments will be conducted immediately after the fourth- and eighth-week treatment period and at a three-month post-treatment follow-up. During these assessments, participants will complete the same validated outcome measures as the baseline assessment to evaluate changes in genitourinary symptoms and quality of life following LLLT.

Eligibility Criteria:
Inclusion Criteria:

* Menopause women
* With genitourinary symptoms of menopause

Exclusion Criteria:

* Acute or chronic infection of the genitourinary tract
* Advanced pelvic organ prolapse (\>= stage 2 on pelvic organ prolapse quantification system)
* History of pelvic malignancy
* Unstable blood pressure
* Fever
* Abnormal sensory nerve
* Abnormal coagulation
NeuroControl of Nicotine Dependence

The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours.


Eligibility Criteria:
Inclusion Criteria:

1. Nicotine Dependence as measured by: Smoke ≥ 8 cigarettes/day for ≥ 2 yrs, expired carbon monoxide (CO) concentration of ≥ 10 ppm, positive urine cotinine test and FTND score ≥ 3 Or ≥ 15 uses of electronic cigarette/day for ≥ 1 year, positive urine cotinine test, and PS-ECDI score ≥ 3
2. English Fluency
3. Functional Vision (with corrective lenses as needed)

Exclusion Criteria:

1. Use of psychotropic and antiepileptic medications in the last month
2. Presence of an untreated illness or serious medical condition
3. History of major neurological illness
4. Contraindication to TMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \>15 min., implanted electronic device, metal in the head) or MRI.
5. Any use of substances that lower seizure threshold.
6. Current or past psychosis
7. Electroconvulsive therapy in the past 6 months
8. Unstable cardiac disease or hypertension, severe renal or liver insufficiency, or sleep apnea
9. BAC greater than 0.0.
10. Positive urine pregnancy test
11. Any other concern that in the investigator's opinion would impact participant safety, study instruction compliance, or confound the interpretation of the study results.
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children

The primary objective of this study is to determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after thoracic surgery.

We hypothesize that patients who are given gabapentin will need fewer morphine equivalents postoperatively than those who were not given gabapentin

This study is a double-blind, placebo controlled, randomized study to explore the effects of gabapentin peri and post operatively. Physician and families will be blinded to the treatment.

60 subjects will be randomized in a 1:1 ratio to either:

* Gabapentin treatment group
* Placebo - control group

We aim to understand the impact that gabapentin use peri and post operatively has on:

1. opioid use based of IV morphine
2. pain scores
3. opioid related complications such as withdrawal
4. effects on the level of sedation
5. Possible adverse effects associated with use of gabapentin
6. Time to extubating

The duration of an individual subject's participation in the study will be 7 days or until the patient is discharged from UC Davis Hospital, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

1. Age newborn to \< 18 years.
2. Gestational age to be minimum 38 weeks.
3. Undergo cardiac surgery via a sternotomy or thoracotomy.
4. Any Thoracic Surgery
5. Planned noncardiac surgery via a thoracotomy or Video Assisted Thoracotomy (VATS).
6. Surgery will result in an inpatient stay of at least 48 hours.

Exclusion Criteria:

1. Use of opioids within 30 days prior to study entry.
2. Renal Failure as defined by RIFLE Criteria.
3. History of seizures requiring active treatment.
4. History of chronic pain treated medically.
5. Diagnosis of Autism.
6. Unable to tolerate enteral medications.
7. Hematology/Oncology patients.
8. Parents/legal guardians unable to consent.
9. Participation in another clinical study presently or within the last 30 days
10. Pregnancy
11. Prisoners
Influence of Sodium Intake on Left Ventricular-arterial Coupling

The objective of the present study is to asses the effectiveness of the aorta-ventricular coupling according to low and high sodium intake in 28 controled hypertensive patients.

Comparison of left ventricular function in two groups of 13 patients according to their different salt's consumption in double blind and crossover study. Performance estimation of the left ventricle by echocardiographic and central arterial pressure by tonometry.

Eligibility Criteria:
Inclusion Criteria:

* Hypertension stage 1, with medium or high risk, when the treatment (mono or therapy without diuretics) is efficient, when the great pressure is reached (\<140/90 mmHg)
* High sodium intake (sodium urinary excretion for 24h (UNaV) \> or = 170 mmol/24h before visit 0
* Limited sodium intake objective (UNaV\<85 mmol/24h)attempted at the end of the limited sodium intake period of 2 weeks
* Patients aged between 18 and 80 years
* Subject has given written informed consent
* Subject has subscribed a health care insurance

Exclusion Criteria:

* Secondary hypertension
* Complications associated with the arterial hypertension : history of cardiovascular diseases or myocardial infarction, cerebrovascular accident, coronary disease, ...
* Arterial hypertension associated with cardiopathy
* Arterial hypertension associated with nephropathy
* Arterial hypertension associated with diabetes
* Measure of central arterial pressure by tonometry is impossible
* Cardiac echogenicity is not satisfactory for the analysis of left ventricular loop analysis
* Patient refuses informed consent
* Follow-up impossible for 15 weeks
* Pregnant or women without efficacy contraception
* Patient without freedom by administration decision
* Patient in exclusion period
* Patient without french insurance
* Adult protected by the law
Advancing Understanding of Transportation Options

This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will (1) test the driving decision aid (DDA) in improving decision making and quality (knowledge, decision conflict, values concordance and behavior intent); and (2) determine its effects on specific subpopulations of older drivers (stratified for cognitive function, decisional capacity, and attitudinally readiness for a mobility transition). The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.

The investigators will use a multi-site, two-armed randomized controlled trial of older drivers (n=300; ≥70 years) from clinical settings, and one family member each (n=up to 300), with longitudinal follow-up. Study goals are to test how much the DDA improves outcomes and identify who benefits most from the DDA. Evaluation of the DDA's efficacy (Aim 1) and its relative effect in subgroups (Aim 2) corresponds to Stage II in the NIH Stage Model for Behavioral Intervention Development. Findings from Aims 1 \& 2 could identify necessary refinements (Stage I) and inform future efficacy, effectiveness or implementation trials.

Eligibility Criteria:
Inclusion Criteria for drivers:

* 70 years or older
* Fluent in English
* At least one medical condition linked in driving cessation
* Drive at least one time per week
* Have a study partner\* (\*drivers interested in participating in the study without a study partner will be placed on a wait list; they may be contacted as a later date for enrollment once 200 driver-study partner dyads have been enrolled across all sites)
* 5-minute MoCA score greater or equal to 21

Exclusion Criteria for drivers:

* In legal custody or institutionalized
* Significant cognitive impairment as measured by 5-minute Montreal Cognitive Assessment (MoCA)
* Since the last time they had their license renewed, has had at least one major change to health, vision, or hearing that has seriously impaired driving (based on potential participant self-report)
* Feels the Department of Motor Vehicles would have serious concerns about their driving (based on potential participant self-report)

Inclusion Criteria for study partners:

* 18 years or older
* Fluent in English
* Identified by Driver participant to contact for potential participation, i.e., part of a driver-study partner dyad
* 5-minute MoCA score greater or equal to 21

Exclusion Criteria for study partners:

* In legal custody or institutionalized
* Significant cognitive impairment as measured by 5-minute Montreal Cognitive Assessment (MoCA)