cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.

Eligible participants, with both a history of recurrent BV and a current episode of BV, will receive a seven-day course of oral metronidazole. Participants who are successfully treated for their BV, and continue to be eligible, will be randomly assigned to receive either 1% SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks.

The primary endpoint will be determined at the conclusion of this 16 week treatment phase.

Participants who experience a BV recurrence will be considered to have completed the study. Such participants will receive BV treatment in line with local practice and will not attend any further study visits.

Participants who successfully reach Week 16 without a BV recurrence will enter a 12-week follow-up phase to Week 28.

Participants will attend a study visit at 4-weekly intervals throughout the duration of the study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Current active episode of BV (diagnosis defined as: At least 3 of the 4 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms)
* History of recurrent BV (at least 3 episodes in previous year including current episode)
* Using an effective method of contraception

Exclusion Criteria:

* Test positive for a sexually transmitted infection
* Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment
* Abnormal pelvic exam, including presence of other vaginal or urinary tract infections
* Pregnancy
Discovering the Effect of Venous Insufficiency on Nocturia

With this prospective controlled trial, we hope to obtain more information about the coexistence between venous insufficiency and nocturia.

In our opinion, venous insufficiency (CEAP 2-3a) leads to an increase in fluid accumulation in the lower limbs due to moving around all day. When laying down during nighttime, this fluid is reabsorbed into the systimic fluid pool, leading to an increase in diuresis and thus an increase in nocturnal voiding. Aim of this study is observe difference in nocturnal frequency and urine production before and after surgical treatment of venous insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* CEAP 2 till 4A

Exclusion Criteria:

* BMI higher than 30
* Previous surgery due to venous insufficiency at the lower limbs
* Cronic edema (Cronic heart failure, liver cirrosis, nefrotic syndrome)
* Pregnant patient
* Patients on the following medication: Calcium-antagonists, lithium, NSAID's or corticosteroids, glitazones, insuline, diuretics, sartans, ACE-inhibitors, desmopressine,
Individual Factors of CBT Underlying Success

The purpose of this study is to understand why some individuals respond fully to cognitive behavioral therapy and others do not, based on multiple sources of data such as neural, neurocognitive, clinical, and self-report data.

The investigators are conducting this research to evaluate the reliability and construct validity of measures of self-focused attention (SFA) across neural, neurocognitive, and self-report levels of analysis as well as examine whether early changes in the SFA biomarker are associated with CBT non-response.

This will be looked at in a clinical population consisting of individuals with social anxiety disorder (SAD) and body dysmorphic disorder (BDD) compared to healthy volunteers. This study employs an open clinical trial for cognitive behavioral therapy with pre-, mid- and post-treatment neuroimaging scans, clinical interviews, neurocognitive, behavioral, and self-report assessments. Clinical participants will be invovled for 3.5 months and complete 12 CBT sessions and 4 fMRI scans. Control participants will not participate in CBT treatment and will complete 3 fMRI scans across a 3.5 month period. About 160 people will take part in this research study, all at the University of Washington (UW). This will include 110 clinical participants and 50 healthy control participants.

Eligibility Criteria:
Inclusion Criteria:

Clinical sample (N=110):

1. Men and women, age 18-45
2. Treatment-seeking individuals who meet criteria for a primary DSM-5 diagnosis of primary social anxiety disorder (SAD) or body dysmorphic disorder (BDD) based on the SCID-5-RV
3. Fluent in English and willing to provide informed consent.

Control sample (N=50):

1. Men and women, age 18-45
2. No current or lifetime history of psychiatric disorders, as assessed using the SCID-5-RV
3. Meet criteria for low levels of anxiety (GAD-7 score of \<8) and depression (PHQ-9 score \<10)
4. Fluent in English and willing to provide informed consent

Exclusion Criteria:

All groups:

1. Score \< 80 based on WRAT5 Word Reading Subtest
2. fMRI contraindications (e.g., electronic medical devices such as pacemakers, implanted defibrillators, etc.; metal implants not approved for MRI; pregnancy; claustrophobia)

2. Active suicidal or homicidal ideation, or any features requiring a higher level of care 3. Lifetime history of manic or hypomanic episode, psychotic symptoms, traumatic brain injury, neurological disorder, pervasive developmental disorder, or attention deficit-hyperactivity disorder; active alcohol or substance use disorder in the past 6 months 4. Current use of psychotropic medications, except antidepressants taken at a stable dose for 3 months prior to study baseline 5. Previous CBT non-responder or current CBT
Vascular CT Assessment of Structural Autograft and Allograft Healing

The purpose of this study is to determine the ability of a cone beam CT to measure bone healing.

The purpose of this study is to investigate quantitative vascular cone beam CT(CBCT) in a clinical pilot of patients that have received a structural allograft for bone cancer or a vascularized structural autograft for bone cancer or traumatic injury. Development of a minimally invasive, longitudinal outcome measure to quantify intramedullary vascular volume and cortical bone volume of structural allografts in patients is required to translate "revitalizing" structural allograft in clinical trials. Our novel vascular CBCT will be able to demonstrate the significant differences between vascularized fibular autografts vs. structural allografts in patients that will undergo structural grafting. These data will be used to devise a power calculation for a definitive clinical trial to evaluate the efficacy of the revitalizing allograft.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* all races will be included
* autograft or allograft of long bone as part of treatment for bone tumor

Exclusion Criteria:

* pregnancy
* patients with a history of IV contrast reactions
* contraindication to use of epinephrine or diphenhydramine
* hypertyroidism or history of sensitivity to iodine
* kidney disease (abnormal urinalysis or calculaged GFR) or poor hydration due to poor intake or other causes
Effects of Genicular Nerve Block in Knee Osteoarthritis

Genicular nerve block is a safe and effective therapeutic procedure for intractable pain associated with chronic knee osteoarthritis (OA). There is increasing support for the neuropathic component to the knee OA pain. Investigators proposed that targeting treatment to the underlying pain mechanism can improve pain management in knee OA. There is a debate on injectable solutions used in nerve blocks. Investigators aimed to investigate the efficacy of genicular nerve block and to determine which solution should be appropriate for patients with knee osteoarthritis who have neuropathic or nociceptive pain.

The patients who participated in this study were selected from outpatients who attended our hospital for knee pain. These 90 patients were who matched the following criteria. All patients had knee pain for more than 3 months.

The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves. This method was used to inject a total of 6 mL of lidocaine or 6 mL dextrose or 6 mL saline at 3 separate target sites: the superior lateral, superior medial, and inferior medial genicular nerves.

Pain was evaluated with Analog Analogue Scale (VAS), daily living activities with Western Ontario and McMaster Universities Arthritis Index (WOMAC), maximum distance walked with Lequesne Score, and neuropathic pain was evaluated with painDETECT inquiry form. Outcome measures were assessed at baseline and at 1st, 4th weeks, and 3rd months after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* knee pain for more than 3 month.
* radiological tibiofemoral OA (Kellgren-Lawrence grade 2-4 )

Exclusion Criteria:

* acute knee pain, prior knee surgery, other connective tissue diseases that affected the knee, serious neurological or psychiatric disorders, steroid or hyaluronic acid injection therapy during the previous 3 months, sciatic pain, patients with polyneuropathy, anticoagulant medication use, pacemaker use, prior electroacupuncture treatment and physical treatment.
The Effect of the Prostate Cancer Foundation Screening Guidelines for Black Men on Intention to Screen in Faith-based Communities

To learn about barriers to prostate cancer screening in Black, faith-based communities. Investigators will use the information collected in this study to create a prostate cancer education program that is relevant to Black men within the church and improve prostate cancer screening.

Primary Objective To determine barriers to prostate cancer screening in Black faith-based communities through focus group assessments which will inform a culturally relevant prostate cancer education and early detection program.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported identification of Black/ African American
* Willingness to participate in the study with signed and dated informed consent

Exclusion Criteria:

* Non-english proficiency
* Unwillingness to participate in the study or inability to sign and date an informed consent
Proyecto SOL: A Risk Reduction Intervention for Hispanic Men Who Have Sex With Men (MSM)

The purpose of this project is to determine the acceptability, feasibility, and the preliminary efficacy of an HIV prevention behavioral intervention (Proyecto SOL) to reduce behaviors associated with HIV acquisition among Hispanic men who have sex with men (HMSM). The primary goal of the intervention is to motivate and assist participants in forming and carrying out a "Safer Options for Life" plan, thereby reducing their risk of HIV acquisition or transmission.


Eligibility Criteria:
Inclusion Criteria:

* self-identify as Hispanic or Latino;
* be between 18 and 49 years of age;
* be a resident of South Florida (Miami-Dade, Broward or Palm Beach counties) and not planning to move out of the area for the next 9 months;
* self-identify as male;
* have had at least one episode of unprotected anal sex with a man in the preceding 3 months;
* have had 2 or more male sex partners in the preceding 3 months;
* be HIV negative or of unknown serostatus;
* speak English and/or Spanish;
* provide informed consent.

Exclusion Criteria:

* have previously participated in any Phase of this study;
* self-identify as transgender;
* not being a resident of South Florida.
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Multiple Sclerosis

This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to Multiple Sclerosis.

The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to Multiple Sclerosis.

This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™ treatment for control of pain due MS. The study has two phases: a Pretreatment Phase and a Treatment Phase.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with MS
* Chronic daily pain present for at least 2 months.
* On stable analgesic regimen for one month
* Baseline pain score greater than 40mm on a visual analog scale.

Exclusion Criteria:

* Hypersensitivity to compounds in study drug or similar drugs
* Pregnant or lactating females
* Drug or alcohol abuse
* Unstable medical condition
A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.


Eligibility Criteria:
Inclusion Criteria:

Main Inclusion at Screening (Visit 1):

* Subject had completed study 178-CL-101 or study 905-EC-012 (This inclusion criterion would no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012 had been completed. In that case the subject had to have symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months);
* Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;

Main Inclusion at Randomization (Visit 2):

* Subject had a micturition frequency of on average ≥ 8 times per 24-hour period during the last 7 days of the micturition diary period (incontinence episode should not be counted as a micturition).
* Subject had experienced at least 3 incontinence episodes during the last 7 days of the micturition diary period.
* Subject had experienced on average at least 1 urgency episode (grade 3 or 4 on Patient Perception of Intensity of Urgency Scale \[PPIUS\]) per 24-hour period during the 7-day micturition diary period.

Exclusion Criteria:

Main Exclusion at Screening (Visit 1):

* Subject had clinically significant bladder outflow obstruction at risk of urinary retention;
* Subject had significant PVR volume (\> 150 mL);
* Subject had significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor;
* Subject has an indwelling catheter or practices intermittent self-catheterization;
* Subject had evidence of a UTI (urine culture containing \> 100,000 cfu/mL), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
* Subject had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;

Main Exclusion at Randomization (Visit 2):

* Subject had evidence of a urinary tract infection (UTI) (urine culture containing \> 100,000 cfu/mL) as assessed in the Screening visit (V1) samples. The subject could be rescreened after successful treatment of the UTI (confirmed by a dipstick negative for nitrite).
* Subject had an average total daily urine volume \> 3000 mL as recorded in the micturition diary period.
Evaluation of the Safety and Performance of Centaflow

The aim of this study is to evaluate the safety and performance of an acoustic approach based on skin-contact microphones as a routine assessment of placental vascular function as predictor of fetal growth restriction.

Evaluation of the safety and performance of Centaflow as routine antenatal assessment of placental vascular function as predictor of fetal growth restriction is performed by randomizing singleton pregnant women with ultrasound-based gestations for either standard care (SC) or SC and Centaflow (CF).

The subjects will be randomized in ratio 1:1 in both groups and examined in pregnancy weeks 27-29, 34-36 and 37-39.

Eligibility Criteria:
Inclusion Criteria

* Female subjects over the age of 18 years.
* Subejct is pregnant, carries only one fetus and has been pregnancy dated by ultrasound scan (Hadlock reference).

Exclusion Criteria

* Fetal abnormality known to affect growth, diagnosed in-utero or through 12 days postnatally.
Validity of SOFA Score as Predictor of Mortality in Critically-ill Burn Patients

SOFA score is valid for mortality predictor for critically-ill patient in high care and intensive care burn unit


Eligibility Criteria:
Inclusion Criteria:

* adult patients (age 18 and above) who admitted to burn unit during sampling period

Exclusion Criteria:

* patients discharged or deceased less than 24 hours of admission
* patients referred to other hospital within 30 days admission
An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients

We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in patients after cardiac surgery who are mechanically ventilated leads to a significant decrease in the amount of fluid given to such patients in the first 24 hours after surgery

1. The investigators will study patients after cardiac surgery
2. The investigators will collect data on standard care in pre-intervention population
3. The investigators will collect demographic and clinical data
4. The investigators will collect biochemical data in the first 24 hours after surgery
5. The investigators will collect biochemical, physiological and clinical outcome data
6. The investigators will compare the standard care and intervention period data

Eligibility Criteria:
Inclusion Criteria:

1. immediately after ICU admission after cardiac surgery
2. mandatory mechanical ventilation -

Exclusion Criteria:

1. Pressure support ventilation
2. ECMO
3. Intra-aortic balloon counterpulsation
Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants

The purpose of this study is to evaluate the effect of vanilla odor on hypoxic intermittent events in premature infants born between 32.0 and 33.6 weeks of gestational age.

A weekly screening will be done on all new hospitalized infants at the neonatal care unit of the CHUS born between 32.0 and 33.6 weeks of gestational age. At the beginning of their 2nd week in the neonatal care unit, infant's medical record will be consulted for inclusion and exclusion criteria. At this moment, no information will be noted. Then, team research will discuss with neonatologist to have their opinion concerning the inclusion of a patient in the study. If they agree, the doctor or the nurse having a therapeutic link with the infant will ask parents' infant if they agree to meet the research team to discuss about the research project. Once the agreement will be obtained, parents will be approached by a member of the research team. Project will be explained, questions will be answered and consent form will be obtained. When an infant will be enrolled in the study, a code will be attributed to him and a randomization will established the order of the intervention.

Option A) night 1: a 12h cardiorespiratory recording with vanilla, night 2: no recording and night 3: a 12h cardiorespiratory recording without vanilla OR Option B): night 1: a 12h cardiorespiratory recording without vanilla, night 2: no recording and night 3: a 12h cardiorespiratory recording recording with vanilla.

All data will be entered in a secured database and a double checked will be done by team members to assess the accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Infants born between 30.0 and 34.0 weeks of gestational age;
* Postnatal age between 3 and 4 weeks;
* No current respiratory or ventilatory support;
* Stable state for at least the last 48 hours;
* Parental consent to enroll in the study.

Exclusion Criteria:

* Respiratory diseases other than apnea;
* Intraventricular hemorrhage grade 3 or 4 OR leukomalacia;
* Chromosomal abnormality;
* Congenital malformations which may result in cardiorespiratory or neurodevelopmental abnormality;
* Clinical deterioration during the study.
Pilot Study Evaluating Neuro-Imaging Correlates of Epigenetic Finding in Prediction of Chronic Postsurgical Pain

This pilot research study is being performed to learn more about pain and look at how pain changes brain chemistry and function. The research team would like to learn new information to better control chronic pain after surgery. This information collected in this research will be used to plan possible future visits. Participants in this study are being asked to participate because they are scheduled for an upcoming surgery. The research team would like to observe them before and after their surgery.

This study is a pilot feasibility study in 30 healthy, preoperative children and young adults undergoing major surgery with high risk for chronic post-surgical pain (CPSP) to characterize the brain metabolite status of the Anterior cingulate cortices (ACC) and insula in pre-surgical adolescents and to understand the relationship between metabolite levels and CPSP. The investigators will also examine whether neurochemical tone in these regions is related to resting state functional connectivity with other brain regions. Correlations between differentially methylated CpG sites in genes enriching gamma aminobutyric acid (GABA) and Dopamine-DARPP-32 pathways and Glu/GABA levels in insula/ACC will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥ 8 yrs of age
2. English speaking;
3. Healthy (Defined as American Society of Anesthesiologists Physical Status 1 or 2)
4. Ability to provide assent/consent/parent permission.
5. Scheduled to undergo chest surgery (thoracotomy, thoracoscopy, Nuss procedure, pectus surgery, mastectomy), spine surgery, amputation, hernia repair or hip/knee replacement.

Exclusion Criteria:

1. History of chronic pain conditions including migraines
2. Use of opioids chronically or for major surgery within the 6 months prior to enrollment
3. Severe obesity (BMI\>35 kg/m2)
4. Taking no more than two concomitant medications known to induce or inhibit CYP2D6 activity, including paroxetine, fluoxetine, cimetidine, and duloxetine or other medications used to treat attention deficit hyperactivity disorder (medications containing amphetamine or methylphenidate).
5. Use of hormonal contraceptives
6. Use of medications that may alter pain sensitivity (e.g. gabapentin,/pregabalin amitryptiline/other antidepressants, clonidine).
7. Active or history of renal/liver problems or congenital cardiac disease
8. Diagnosed developmental delay
9. Pregnant or lactating females
10. Any skin condition that prevents cuff application
11. History of seizures
12. Claustrophobia
13. Metallic implants/orthodontics/braces or other MRI exclusion (MRI safety screening will be conducted prior to enrollment and prior to each MRI scan)