cyrilzakka/clinical-trials huggingface dataset:
Dapivirine Gel Rectal Safety and PK Study

Dapivirine Gel Rectal Safety and PK Study

A Randomized, Double Blind, Placebo-Controlled Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 - 45 years (inclusive), verified per site SOP
* Able and willing to provide written informed consent
* HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II and willing to receive HIV test results
* Able and willing to provide adequate locator information, as defined in site SOP
* Available to return for all study visits and willing to comply with study participation requirements
* In general good health at Screening and Enrollment, as determined by the site IoR or designee
* Per participant report, a history of consensual RAI at least once in the past calendar year
* Willing to not take part in other research studies involving drugs, medical devices, genital products, or vaccines for the duration of study participation, including the time between Screening and Enrollment

Exclusion Criteria: At Screening:

* Hemoglobin Grade 1 or higher\*
* Platelet count Grade 1 or higher\*
* White blood count Grade 2 or higher\*
* Serum creatinine 1.3 the site laboratory upper limit of normal (ULN)
* International normalized ratio (INR) 1.5 the site laboratory ULN
* Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher\*
* Positive for hepatitis C antibody
* Positive for hepatitis B surface antigen
* History of inflammatory bowel disease by participant report
Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia

Fluid management is a fundamental aspect of anesthesia. Several monitorization methods have been introduced to optimize fuid management.

To date neither of them were ideal. Corrected flow time measurement (FTc) in the carotid artery was recently introduced to detect fluid responsiveness.

Spinal anesthesia causes hypotension and fluid preloading is suggested to overcome this problem.

The aim of this study is to evaluate the effect of FTc guided fluid loading on spinal anesthesia induced hypotension.

Patients will be randomly allocated into 3 groups. Group C (Control) will receive spinal anesthesia after initiation of intravenous (iv) access without fluid preloading and will receive 2 ml/kg Ringer's lactate during anesthesia..

Group P (preloading) will receive 10 ml/kg Ringer's lactate before spinal block.

In Group FTc, ultrasonographic measurement of corrected flow time in carotid artery will be measured using 10-5 megahertz linear probe. On the two-dimensional image, the optimal image of the long-axis view will be obtained at the left common carotid artery. The sample volume will be placed on the center of the lumen, 2 cm proximal to the bulb, and a pulsed wave Doppler examination will be performed. Cardiac cycle time and carotid flow time will be measured. Carotid flow time will be measured between the upstroke of the flow tracing and the dicrotic notch, and it will be corrected for pulse rate by dividing flow time by the square root of the cardiac cycle time to calculate corrected carotid artery flow time (flow time/√cycle time).

The blood pressure will be measured 5 minutes before spinal anesthesia is commenced (baseline) and every minute afterwards until end of surgery.

Group FTc will receive a 500 mL Ringer's lactate bolus if the FTc is \<349 ms (fluid responder); the FTc measurement will be repeated 15 minutes later and additional 500 mL Ringer's lactate bolus will be applied if the patient is still considered fluid responder; this sequence will be repeated until the patient's FTc is \> 349 ms (non responder).

Ephedrine bolus will be used in allh groups if the mean arterial pressure drops below 30% of the baseline value.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (19-80 years of age) who were scheduled to undergo arthroscopic knee surgery under spinal anesthesia

Exclusion Criteria:

* Mean blood pressure \< 70 mmHg before induction of general anesthesia
* Patients who have currently taken angiotensin-converting enzyme inhibitor
* Patients who have currently taken angiotensin receptor blocker
* the presence of carotid artery stenosis \> 50%
* cardiac rhythm other than sinus
* unstable angina
* a left ventricular ejection fraction of \< 40%
* severe vascular disease
* implanted pacemaker/cardioverter
* autonomic nervous system disorders
* pregnancy
Genomic Grade Index (GGI): Feasibility in Routine Practice and Impact on Treatment Decisions in Early Breast Cancer

In this prospective study the investigators sought to evaluate the feasibility of using the genomic signature - Genomic Grade Index (GGI) - in routine clinical practice and its impact on treatment recommendations.

The primary objective of this study was to evaluate the feasibility of implementing Genomic Grade Index (GGI) in community hospitals in Belgium for breast cancer patients with node negative and 1-3 node positive early breast cancer. GGI would be considered a feasible genomic test if results were obtained in \> 70% of evaluated patients.

Eligibility Criteria:
Inclusion Criteria:

Histologically confirmed invasive breast cancer meeting the following criteria:

* T1, T2, or operable T3 disease
* Zero to three positive lymph nodes and no distant metastases
* Operable disease - Must have undergone breast-conserving surgery or mastectomy with either a sentinel node procedure or full axillary clearance

Exclusion Criteria:

* No other invasive cancer within the past 5 years except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude entering into a clinical study
The Investigation of Public Awareness of Core Stroke Symptoms

To investigate public awareness of core stroke symptoms in more than 40 years old population and its related factors.


Eligibility Criteria:
Inclusion Criteria:

* More than 40 years old (born before December 31st 1976) without specific requirements.
* Be able to finish the questionnaire.

Exclusion Criteria:

* Participants with disturbance of consciousness.
Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy

Neonatal hypoxic ischemic encephalopathy (HIE) is a serious neurological condition characterised by acute or subacute brain injury arising from perinatal hypoxia. HIE is thought to affect approximately 0.2% of live births, and is associated with a high risk of mortality or long-term neurological disability.

Accurate biomarkers for long-term neuro-developmental outcome following HIE are extremely important both for clinical management and the evaluation of therapeutic approaches. According to a recent meta-analysis, the ratio of the cerebral concentrations of lactate and N-acetyl aspartate (NAA), two neuro-metabolites detectable with magnetic resonance spectroscopy (MRS), currently represents the most accurate prognostic indicator of outcome following HIE. However, for various technical reasons standard MRS methods do not offer optimal sensitivity for detecting lactate, which may potentially be improved with a custom lactate editing MRS sequence. In addition, while perfusion has also been suggested as a potential biomarker for neuro-developmental outcome following HIE, due to a paucity of MR perfusion imaging studies in neonates, the prognostic accuracy of perfusion MR measures has not been evaluated in comparison with more established MR biomarkers. The aims of this study are:

1. to evaluate the relative sensitivity of a custom lactate editing MRS pulse sequence (specialist software) relative to the standard point resolved (PRESS) MRS sequence for detecting lactate in neonates with suspected HIE.
2. to evaluate the sensitivity and specificity of MR perfusion measures in comparison to MRS measures as predictors of neuro-developmental outcome at 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Newborn infants (born at \>36 weeks) with suspected perinatal asphyxia. Written informed consent from both parents.

Exclusion Criteria:

* Prematurity (born at \< 36 weeks). Lack of written informed consent from both parents.
Identification of Modifying Factors in Hereditary Spastic Paraplegia

A first questionnaire - MODIFSPA conducted in 2014 - identified several environmental factors influencing spasticity in HSP: cold, fatigue, and especially physical activity. In order to improve the care of patients with HSP, The investigator team are looking to deepen the knowledge on physical exercises relieving spasticity as well as to better know the frequency of symptoms requiring additional medical care: fatigue and vesico-sphincter disorders. A new questionnaire was therefore created to collect additional information to optimize the care of patients with HSP.

The only common symptom of hereditary spastic paraplegia (HSP) is the presence of spasticity in the lower limbs, associated with a great clinical and genetic heterogeneity.

A first MODIFSPA study carried out by the team identified environmental factors influencing spasticity: stress, fatigue, physical activity. In this first study, only spasticity was studied but several symptoms appeared to require medical management according to the patients: fatigue and vesico-sphincter disorders.

Following this first study, MODIFSPA2 aims to deepen our knowledge of HSP, via the expertise of patients, to propose a care in adequacy with their needs/demands.

Validated scales are included in the questionnaire to evaluate the frequency and intensity of the symptoms most reported by patients (fatigue, pain and mood disorders). Questions are asked to better know the frequency of symptoms requiring additional medical care: fatigue and vesico-sphincter disorders.

Eligibility Criteria:
Inclusion Criteria:

* French-speaking adult patients aware of their PSH diagnosis coming to the genetic consultation at the Pitié-Salpêtrière Hospital or informed via an association / website of the BRAINTEAM study network
* Affiliated with social security

Exclusion Criteria:

* NA
The Effect of Perioperative and Postoperative Music Reduces Pain Perception After Anterior Cruciate Ligament Reconstruction

study the effect of music therapy in pre-operative and post operative period and measure the out come by the visual analog scale (pain score) and analgesic drug use such as morphine and the anxiety score

Objectives Primary Objective : To study and compare pain symptoms between the group of patients after undergoing Anterior Cruciate Ligament reconstruction surgery and the control group, using pain relievers along with listening to music perioperatively and postoperatively.

Secondary Objective : To study and compare the levels of anxiety and changes in the circulatory system among patients after undergoing Anterior Cruciate Ligament reconstruction surgery and the control group, from listening to music perioperatively and postoperatively.

Research Questions Does listening to music perioperatively and postoperatively during Arthroscopic Anterior Cruciate Ligament reconstruction surgery help reduce postoperative pain?

Hypothesis The group of patients who listened to music perioperatively and postoperatively during Arthroscopic Anterior Cruciate Ligament reconstruction surgery will experience reduced postoperative pain compared to the group that did not listen to music.

Methodology Randomized Controlled Trial (RCT) Sample Size Calculation The calculation of the sample size for testing two independent means, using the method referenced from the study by Xavier C. Simcock and colleagues on "Intraoperative Music Reduces Perceived Pain After Total Knee Arthroplasty total 38 and add 20% for dropout rate

Inclusion criteria

1. Patient age : More than 18 years old
2. The patient have diagnosis ACL injury by MRI and go on surgery by arthroscopic surgery Exclusion criteria

1. History of knee surgery before this visit 2. ACL injury with multiple ligament injury 3. Hearing loss 4. Denial to surgery or include to study

Study Design \& Method This study was a randomized control trial of patient knowns ACL injury and undergoing arthroscopic ACL reconstruction surgery between 2022 to 2023. A total 46 patients were included 23 patients in intervention and 23patients in control group. All patients were evaluated using VAS and anxiety scale preoperative and postoperative and intravenous analgesic drug use at 1,3,12,24,48,72 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis Anterior cruciate ligament tear from MRI
* Plan to surgery by arthroscopic ACL reconstruction
* must able to listening music from headphone

Exclusion Criteria:

* Hearing problem
* History of morphine and pethidine allergy
* History of previous knee surgery
* intraoperative finding multiple ligament injury
An Interaction Study of LY3200882 in Healthy Participants

The main purpose of this study is to evaluate the effect of itraconazole on the amount of LY3200882 in the blood stream and how long the body takes to get rid of LY3200882. The safety and tolerability of LY3200882 when given with itraconazole will be evaluated. The study is expected to last up to 19 days from the first dose to follow-up (inclusive). Screening will occur up to 28 days prior to enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or postmenopausal females, as determined by medical history and physical examination

Exclusion Criteria:

* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Have used or intend to use over-the-counter or prescription medication including herbal medications within 14 days prior to dosing and during the study (with the exception of vitamins and occasional acetaminophen or ibuprofen, which will be permitted at the discretion of the investigator). Drugs that are known substrates, inducers, or inhibitors of CYP3A4 are specifically excluded within 30 days of dosing and throughout the study
Effectiveness of Egg Versus Whey Protein Powder During Resistance Training

Consumption of whole eggs has recently been shown to stimulate muscle protein synthesis to a greater degree than consumption of egg whites after a resistance training session. It is theorized that the egg yoke contains bio-active nutrients that enhance the protein provided by egg whites. The study will evaluate the effect of whole egg powder compared to whey protein powder and placebo over 12 weeks of resistance training in men and women who are participating in resistance training programs.

Consuming whole eggs after resistance training sessions appears to be more effective for simulating muscle protein synthesis that simply consuming egg whites. The egg yolks might enhance the effect of protein derived from egg whites. The study will compare post-exercise supplementation with about 30 grams of protein derived from whole egg powder versus whey protein powder and placebo (maltodextrin) over a 12-week resistance training program. Resistance-trained men and women (n=120) will be randomized to consume either the whole-egg powder, whey protein powder or maltodextrin after resistance training 6 times per week for 12 weeks. The primary outcome measure is change in lean tissue mass. Secondary measures include change in fat mass, change in arm and leg muscle thickness, change in bench press, squat, and knee extension strength, and change in fasting blood glucose.

Eligibility Criteria:
Inclusion Criteria:

* Resistance training experience for at least one year

Exclusion Criteria:

* Having taken any nutritional supplements the past 30 days
* Currently using anabolic steroids
* Currently taking corticosteroids
* Allergies to dairy or egg products
* Identifying any medical conditions as determined by the "Get Active Questionnaire"
Safety and Feasibility Evaluation of the APS APP

This clinical trial is a safety and feasibility study to assess the performance of artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the APS APP platform.

The system will be evaluated on up to 10 adult subjects with type 1 diabetes age 18-75 years old at a single clinical site (Sansum Diabetes Research Institute), who will complete a 48-hour closed-loop (CL) session in an observed CRC environment with medical staff present. During the session subjects will bolus for all meals and snacks and perform a 45-minute walking session while supervised by medical staff. The AP system used consists of an insulin pump, a CGM sensor, and a phone app (the Artificial Pancreas System \[APS\] phone app).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 75 years at the time of screening.
* Clinical diagnosis of type 1 diabetes for at least one year.
* Has been using an insulin pump for at least 6 months at the time of screening.
* HbA1c \< 10.5%.
* Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate.
* Willing to perform at least 7 fingerstick blood glucose tests a day.
* If using Apidra (insulin glulisine) at home and planning to use the Tandem t:AP pump for the closed-loop session, willing to switch to Novolog or Humalog for the closed-loop session.
* Willing to refrain from taking acetaminophen products for the duration of the clinical trial.
* Willing to abide by the study protocol and use study-provided devices, including the Omnipod OR Tandem Pump, Dexcom CGM, glucometer, ketone meter and APS APP on the study phone device.

Exclusion Criteria:

* Pregnancy
* One or more episodes of hypoglycemia requiring an emergency room visit or hospitalization in the past 6 months.
* One or more episodes of hyperglycemia requiring an emergency room visit or hospitalization in the past 6 months.
* Known unstable cardiac disease or untreated cardiac disease, as revealed by history or physical examination.
* Dermatological conditions that would preclude wearing a CGM sensor or Pod/infusion site.
* One or more seizures in the past year.
* Any condition that could interfere with participating in the trial, based on investigator judgment.
* Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer

This phase II trial investigates how well oral cryotherapy plus acupressure and acupuncture compared with oral cryotherapy alone work in decreasing chemotherapy-induced peripheral neuropathy in patients with gastrointestinal cancer who are receiving oxaliplatin-based chemotherapy. Acupressure is the application of pressure or localized massage to specific sites on the body to control symptoms such as pain or nausea. Acupuncture is the technique of inserting thin needles through the skin at specific points on the body to control pain and other symptoms. Cryotherapy uses cold temperature such as oral ice chips to prevent abnormally increased pain sensation. Giving oral cryotherapy with acupressure and acupuncture may work better in decreasing chemotherapy-induced peripheral neuropathy from oxaliplatin-based chemotherapy in patients with gastrointestinal cancer compared to oral cryotherapy alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy.

ARM II: Patients undergo standard of care oral cryotherapy.

Eligibility Criteria:
Inclusion Criteria:

* GI cancer (primary esophagus, gastric, pancreas, biliary, liver, small bowel, appendix, colon, rectal, anal, or gastrointestinal/pancreatic neuroendocrine tumor) scheduled to receive a new start of fluorouracil (5-FU), oxaliplatin, +/- irinotecan (fluorouracil/leucovorin calcium/oxaliplatin \[FOLFOX\], fluorouracil/irinotecan/leucovorin calcium/oxaliplatin \[FOLFIRINOX\], leucovorin/fluorouracil/oxaliplatin/irinotecan \[FOLFOXIRI\] regimens) with plan for \>= 3 months of therapy with the regimen. Chemotherapy can be given for neoadjuvant, adjuvant, or palliative intent. 1 dose (cycle) of the intended regimen is permitted prior to study enrollment.

  \*\*There is no limitation on the addition of a biologic agent to one of the above chemotherapy regimens, including, but not limited to: bevacizumab, cetuximab, panitumumab, trastuzumab, or the biosimilars of these agents
* Age \>=18 years
* Absolute neutrophil count \> 0.5 thousand/microL
* Platelet count \> 20 thousand/microL
* Not currently pregnant
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Baseline peripheral neuropathy from any cause
* Planned oxaliplatin with capecitabine
* Planned initial dose of oxaliplatin \< 100% of the standard regimen-specified dose. For most regimens, this would be 85 mg/m\^2 intravenously (IV) dosed every 14 days
* Receipt of acupuncture treatment in the prior 3 months
* Use of concomitant duloxetine for minimization of neuropathy
* Psychiatric illness/social situations that would limit compliance with study requirements