cyrilzakka/clinical-trials huggingface dataset:
Near Infrared Transillumination of the Paranasal Sinuses

This research project designed to diagnose sinusitis using a simple and low-cost optical tool. Healthy sinuses are typically filled with air, and show up as bright spots on the camera. Infected sinuses are filled with fluid and show up dark spots on the camera. Images of infected sinuses could be used to diagnose sinusitis, or to check if surgical treatments on the sinuses have been successful.

This device consists of a specialized flashlight that uses mostly non-visible light, and a small camera to record the light. The tool is the size and shape of spoon. The technique of shining light into the mouth, face, and sinuses is known as "transillumination" and has been used for nearly a century to aid in the diagnosis of sinusitis. The tool described in this study is a custom made device that uses light that is invisible to the eye.

Eligibility Criteria:
Inclusion Criteria:

* male and female age of 15 years or older.
* Has diagnose of sinusitis, nasal allergies,nasal breathing problem, and tumors.

Exclusion Criteria:

* Age less than 15 year sold
The Biology of Claudin 3 in Primary Human Mammary Epithelial Cell Culture

The objective of the present study is to determine whether or not primary human mammary epithelial cells are competent for use in molecular studies of transepithelial electrophysiology focusing on the function of the tight junction protein claudin 3.

Human breast Tissue will be removed from mastectomy specimens and used as a source to generate epithelial cells for study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of this pilot study are limited to those female patients who are undergoing therapeutic or prophylactic mastectomy procedures conducted by the department of Surgery at HUMC.

Exclusion Criteria:

* From within this population, no exclusion criteria shall be applied based on age, race, ethnicity, gender, HIV status, or menopause.
Preemptive Dexamethasone , Paracetamol on Postoperative Period Following Adeno-tonsillectomy in Pediatric .

Tonsillectomy is one of the most common surgical operations performed on children, and it is frequently linked with an increased risk of complications such as acute discomfort when swallowing and postoperative nausea and vomiting (PONV).The most prevalent causes for postponing discharge home are poorly managed pain and PONV.

Tonsillectomy is one of the most common surgical operations performed on children, and it is frequently linked with an increased risk of complications such as acute discomfort when swallowing and postoperative nausea and vomiting (PONV). The most prevalent causes for postponing discharge home are poorly managed pain and PONV. As a result, these occurrences should be avoided and managed utilizing a multimodal strategy Because of its low cost and adequate safety profile in the treatment of post-tonsillectomy pain, acetaminophen is presently regarded the fundamental analgesic in this situation. Furthermore, acetaminophen has been recommended for use in children, and its pharmacological safety in this age group has been shown. Dexamethasone is another medication that is used to reduce postoperative pain and PONV in various procedures.

Eligibility Criteria:
Inclusion Criteria:

* children aged between 3 and 16 years.
* All patients are ASA physical status I or II scheduled to undergo a tonsillectomy with or without adenoidectomy using sharp dissection technique.

Exclusion Criteria:

* psychiatric illness.
* cardiac disease.
* renal or hepatic impairment.
* allergy dexamethasone , paracetamol and opioids.
Treatment of Participants With Advanced and/or Refractory Solid Tumors (MK-5108-001)

This study will investigate the safety, side effects and how well the body tolerates MK-5108 as well as determine different doses of MK-5108 in participants with advanced and/or refractory solid tumors. The corresponding primary hypotheses of this study are that 1) administration of oral MK-5108 (twice daily for 2 out of 14-21 days) to participants with advanced and/or refractory solid tumors will be safe and tolerable, and that 2) the spectrum of side effects observed in these participants after administration of oral MK-5108 alone and in combination with docetaxel will be dose-dependent and allow for definition of a maximum tolerated dose (MTD).


Eligibility Criteria:
Inclusion Criteria:

- Participant has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy or progressed with standard therapy

Exclusion Criteria:

* Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks prior to study start or has not recovered from adverse events caused by therapy more than 4 weeks earlier
* Participant is currently participating or has participated in a study with an investigational compound or device within 4 weeks prior to signing informed consent
* Participant has received more than 2 courses of chemotherapy for metastatic disease
* Participant has had prolonged neutropenia or neutropenia with fever from previous chemotherapy treatment
* Participant has a primary central nervous system tumor
* Participant is a regular or recreational user of any illicit drugs or has a recent history within the last year of drug or alcohol abuse
* Participant is pregnant, breastfeeding or planning to have children during the study
* Participant is Human Immunodeficiency Virus (HIV) positive
* Participant has a history of Hepatitis B or C
COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection

The primary objective of the study is to assess the virologic efficacy of REGN10933+REGN10987 across different intravenous and subcutaneous doses compared to placebo.

The secondary objectives of the study are:

* To evaluate additional indicators of virologic efficacy of REGN10933+REGN10987 compared to placebo
* To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
* To assess the concentrations of REGN10933 and REGN10987 in serum over time
* To assess the immunogenicity of REGN10933 and REGN10987


Eligibility Criteria:
Key Inclusion Criteria:

* Has SARS-CoV-2-positive diagnostic test from a sample collected ≤72 hours prior to randomization, as defined by the protocol
* Low-risk symptomatic patient: Has symptoms consistent with COVID-19 (as determined by the investigator) with onset ≤7 days before randomization, and meets all of the following 8 criteria:

  1. Age ≤50
  2. No obesity, with obesity defined as BMI ≥30 kg/m2
  3. Does not have cardiovascular disease or hypertension
  4. Does not have chronic lung disease or asthma
  5. Does not have type 1 or type 2 diabetes mellitus
  6. Does not have chronic kidney disease, with or without dialysis
  7. Does not have chronic liver disease
  8. Is not pregnant or
* Asymptomatic patient: Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time \<2 months prior to randomization
* Maintains O2 saturation ≥93% on room air

Key Exclusion Criteria:

* Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization
* Has a known positive SARS-CoV-2 serologic test
* Has a positive SARS-CoV-2 antigen or molecular diagnostic test from a sample collected \>72 hours prior to randomization
* Is immunosuppressed, based on investigator's assessment
* Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
* Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, (eg, bamlanivimab), IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)
* Prior use (prior to randomization), current use (at randomization), or planned use (within time period given per CDC guidance but no sooner than 22 days of study drug administration) of any authorized or approved vaccine for COVID-19
* Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test
* Has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational vaccine for COVID-19

NOTE: Other protocol defined inclusion/exclusion criteria apply
Peripheral Sensory Input in Central Post Stroke Pain (CPSP)

Prospective, open-label study in 10 patients with Central Post Stroke Pain (CPSP). The study will evaluate the effects of peripheral nerve blockade on spontaneous pain and evoked thermal and mechanical responses in CPSP, and assesses the associated local anesthetic pharmacokinetics.


Eligibility Criteria:
Each subject must meet all of the following criteria:

* Age ≥18;
* CPSP affecting an upper or a lower limb, in a distribution that may be completely covered by a peripheral nerve block;
* Patient fulfills all mandatory criteria for CPSP, fulfills at least one supportive criteria, and has definite CPSP by probability grading.
* Pain duration at least 3 months;
* Spontaneous pain intensity (average pain in past week) of ≥ 4 on 0-10 Numerical Rating Scale (NRS).

Exclusion Criteria

Subjects will not be enrolled if any of the following criteria exist:

* Not giving consent to participate in the study;
* Significant psychiatric or cognitive impairment;
* Moderate to severe renal or liver failure;
* Concomitant treatment with warfarin or other anticoagulants;
* Pregnancy or lactation.
Syringe Service Based Telemedicine and Social Network Driven HIV Prevention Service Implementation

The goal of this clinical trial is to evaluate the effectiveness of a social network intervention to recruit people who inject drugs and their networks for HIV testing and linkage to HIV prevention and treatment services in Maryland. Study aims are to determine the effectiveness of a social network driven intervention to increase:

* HIV testing (primary);
* PrEP knowledge;
* Uptake of HIV services and pre-exposure prophylaxis (PrEP);
* Uptake of medication for opioid use disorder (MOUD) initiation.

Eligible participants who access syringe service programs (SSPs) serving two counties in Maryland and their risk network members (NMs) will be recruited using an established network inventory and coupon recruitment method. When an index successfully recruits NMs, the index-NM cluster will be randomized to either a peer-educator intervention arm or an equal-attention control arm. Index participants randomized to the peer-educator intervention arm will complete a training program adapted with stakeholder input to context that emphasizes effective communication, frequent HIV testing, and awareness of evidence-based HIV prevention and treatment services. An important innovation to the network intervention will be training indexes to use and distribute HIV self-test kits and naloxone to their NMs. Index participants randomized to the equal-attention control arm will receive training sessions focused on the opioid overdose epidemic and will not include any training to serve as a peer educator. All participants (indexes and NMs) will complete study assessments at baseline and at 3 and 9 months. We will compare the peer-educator intervention group and the equal-attention control group on rates of HIV testing, knowledge of PrEP options and resources, and rates of initiation of HIV treatment, PrEP, and MOUD treatment since the previous assessment (past 3 or 6 months).


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for index participants:

* Aged 18 or older
* Self-reported injection drug use in the prior month
* Accessed services at the SSP in the prior 3 months
* Willing to undergo training and attend weekly booster group sessions
* Able to recruit at least 1 drug use Network Member (NM) into study
* Willing to talk with peers about PWID topics such as HIV prevention and care
* Not previously enrolled in the study as index or NM
* English-speaking

Inclusion criteria for network member participants:

* Aged 18 or older
* Self-reported injection drug use in the prior month
* Have a valid coupon or able to recall the 3-digit ID number
* Not previously enrolled in the study as index or NM
* English-speaking

Exclusion criteria:

• Individuals lacking the capacity to consent
Evaluation of a Psychoeducational Intervention for People With Suicidal Behaviour in the Penitentiary Environment. N'VIU Project

Objective. The main objective is to determine the effectiveness of a psychoeducational program conducted by rehabilitation professionals to reduce the number of suicidal behaviors in prisons.

Methodology. The design of the study will be a multicenter, randomized, two-group clinical trial with blind evaluation of response variables, one year follow-up. The study population will be a male and female prison population of a total of two Catalan prisons. As a dependent or outcome variable, the total number of suicidal behaviors recorded for 12 months after the intervention will be determined. As independent variables, socio-demographic, clinical and prison situation variables will be collected. The suicidal ideation will be measured with the Columbia-Suicide Severity Rating Scale (C-SSRS). The anxiety and depression with Hamilton scale for assessing anxiety (HDRS) and the Hamilton scale for assessing severity of depressive symptoms (HAM-D). The EuroQoL-5D Health Questionnaire (EQ-5D) to measure quality of life. And a satisfaction survey of psychoeducational group intervention. Participants who meet the inclusion criteria will be divided into two groups, an intervention group that will conduct group sessions with a frequency of two per week and duration of 90 minutes for a total of 13 sessions, and a control group that will receive information on suicide counseling.

Discussion. Mortality from suicide is higher in the prison population than in the general population. This project aims to evaluate the effect of a psychoeducational intervention on reducing the number of suicidal behaviors in prison, in order to evaluate their implementation at the level of the entire prison network.


Eligibility Criteria:
Inclusion Criteria:

-People who have attempted suicide or a risk of suicide moderate to high.

Exclusion Criteria:

* People with a mental disorder in a state of acute exacerbation
* Intellectual disability
* Cognitive impairment
Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for a Single Male Patient With Duchenne Muscular Dystrophy (DMD)

This research study is designed to evaluate the effects of human umbilical cord mesenchymal stem cells (UC-MSCs), on Duchenne's muscular dystrophy (DMD). The potential muscle regenerative and anti-inflammatory properties of UC MSCs position them as a possible treatment option for DMD. Both of these properties could lead to potential benefits for a DMD patient.


Eligibility Criteria:
Inclusion Criteria:

* Duchenne's Muscular Dystrophy

Exclusion Criteria:

* None
NIT-OCCLUD PDA Phase II Sentinel Trial

The purpose of this study is to evaluate the safety and efficacy of the Nit-Occlud -PDA Occlusion System for transcatheter closure of PDA with minimum angiographic diameter less than 4 mm, and to compare one year safety and efficacy outcomes with recommended OPCs.

The purpose of this clinical investigation is to evaluate whether transcatheter occlusion of PDAs with a minimum vessel diameter of 4 mm or smaller, by means of permanent implantation of the Nit-Occlud Spiral Coil for PDA Occlusion, is safe and effective.

The device used for this purpose is a set of two items named "Nit-Occlud - PDA Occlusion System":

* Nit-Occlud coils, 2 types: flexible (3 sizes) and medium (3 sizes)
* Introducer Sheath, F4 or F5 85cm.

The intended use of the device is the percutaneous, transluminal closure of PDA with an internal diameter or 4mm and smaller in patients who comply with the selection criteria.

The investigation will continue until the sponsor receives FDA approval for commercial distribution and implantation of the system, or until the project is terminated by the sponsor or by the investigators.

The objectives of this study are:

1. To determine the safety of the spiral coil by monitoring and reporting deaths and adverse events associated with the device and device placement.
2. To determine the effectiveness of the spiral coil by evaluating clinical and echocardiographic occlusion rates.

Eligibility Criteria:
Inclusion Criteria:

* PDA with 4 mm or smaller minimum diameter by color Doppler
* Patent weight \> 5 Kg, Age 6 months to 21 years (Patients older than 21 years may have device implant and be included in a study registry.)
* Previous treatment by surgery or Nit-Occlud device with residual PDA noted at least 6 months after the procedure
* Angiographic minimum PDA diameter (D1) less than 4 mm. (Patients with angiographic diameters larger than 4 mm and smaller or equal to 5 mm may have device implant and be included in a study registry.)

Exclusion Criteria:

* Associated cardiac anomalies requiring surgery
* Known bleeding or blood clotting disorders
* Ongoing febrile illness
* Pregnancy
* Pulmonary hypertension/increased pulmonary vascular resistance (\>5 Wood Units)
* Known hypersensitivity to contrast medium
Intravascular Access in Suspected/Confirmed COVID-19 Patient

The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC medical personnel should be equipped with full personal protective equipment (PPE) for AGP in contact with suspected/confirmed COVID-19 patient. Therefore, it is reasonable to search for the most effective methods of intravascular access in those conditions.


Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital cardiac arrest (OHCA)
* Adult ≥ 18 years old
* Non-traumatic cause of cardiac arrest

Exclusion Criteria:

* Existing do-not-attempt-resuscitation order
* OHCA patients with contraindications to IO access or IV access
* Patients with signs of obvious death, e.g. rigor mortis
Conditioned Placebo Effects and Treatment of Hypertension

To compare the unconditioned and conditioned effects of placebo capsules in the treatment of patients with borderline hypertension (BH).

DESIGN NARRATIVE:

This study will compare the unconditioned and conditioned effects of placebo capsules in the treatment of patients with borderline hypertension (BH). The use of placebos is routine in trials of antihypertensive medication, but the placebo is nearly always given before the active drug, and most studies have relied on traditional clinic measurement of blood pressure (BP). However, ambulatory BP monitoring (ABPM) is the gold standard for evaluating the effectiveness of any antihypertensive treatment, and placebo effects on ABP have mostly been negligible. However, there is also evidence that when a placebo is given after the active drug, there may be a more profound effect. A long series of both animal and human studies by the co-principal investigator (Dr. Ader) have shown that such learned or classically conditioned placebo effects may have genuinely therapeutic effects. One such study, which will provide the basis for the current study, found that placebo given after the active drug lowered home BP, but ABP was not evaluated. The current study will extend the previous one, and will be performed in Community Health Centers, in a culturally diverse, economically disadvantaged population. 120 patients with untreated BH will have their BPs monitored by clinic, home, and ABP recording. After a 4-week run-in period of telephone-linked home monitoring (continued throughout the study) they will be randomized to 3 groups: no drug, active drug (a beta blocker-diuretic combination), or matching placebo. This will enable evaluation of the unconditioned placebo effect. For the next 4 weeks all 3 groups will receive active drug. ABPM and clinic BP will be measured at the end of each period. For the final period patients in each group will be randomized to no drug or placebo. ABPM and clinic BP will be measured after 2 weeks, but home BP will continue until BP returns to 140/90 mmHg. It is hypothesized that the conditioned placebo effect will result in a delayed return of BP to pretreatment levels, and the inclusion of the No Drug group will distinguish this from the effects of drug washout. To promote and assess compliance with the medications, electronic containers (MEMscaps) will be used. The demonstration of a conditioned placebo effect that produces a sustained reduction of BP could result in more economical treatment with fewer side effects.

Eligibility Criteria:
No eligibility criteria
Tailored to You (TTY) Pilot Study

The purpose of this research study is to use a test called impedance cardiography (ICG) to provide more information about how to improve the control of blood pressure. Participants will be given this test so investigators can get more information about what is going on inside the heart and blood vessels that is contributing to high blood pressure. ICG is a lot like an EKG (electrocardiogram) in that it uses electrodes and a computer to make a report. Participants will lie down on the exam table and two electrodes go on the right ankle and two electrodes go on the left wrist. The process takes about 5 minutes and is painless and not invasive.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of hypertension
* Most recent office systolic BP average measured using automated office BP (AOBP) is ≥140 mmHg systolic or ≥90 mmHg diastolic
* Currently prescribed at least one BP-lowering medication
* Under the care of a primary care clinician

Exclusion Criteria:

-
Vaginal Microbiome-host Interaction in Mesh Exposure After TVM Surgery

Transvaginal pelvic mesh implantation（TVM） is a foreign body implantation operation with intraoperative colonization of vaginal bacteria. However, the vaginal microbiome-host interaction and its influence in the mechanism of mesh exposure after TVM remains unclear. This study will enroll post-TVM patients with and without mesh exposure and use their vaginal swabs to perform TRACE-seq and cytokine analysis. The microbiome-host interactions related with mesh exposure and the changes in protein expression will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with "III-IV degree uterine/apex/anterior vaginal wall prolapse and I-II degree of posterior vaginal wall prolapse" who agree to be treated by transvaginal pelvic mesh implantation.
* All surgeries were performed by surgeons with extensive experience in transvaginal mesh implantation (\>20 vaginal mesh implantation per year) using macroporous, monofilament, polypropylene mesh.

Exclusion Criteria:

* 1. Have had sex in the past 5 days or had vaginal irrigation;
* 2. Use oral or vaginal antibiotics, antifungal, immunosuppressant, hormone drugs or probiotics for the last 30 days.
* 3. Combined with immunosuppressive diseases, diseases with contraindication of vaginal estrogen such as breast cancer, endometrial cancer.
* 4. If the patient has a uterus before surgery and does not undergo total transvaginal hysterectomy during surgery,
* 5. Intraoperative bladder injury or intraoperative hemorrhage \>500ml or postoperative hematoma.