cyrilzakka/clinical-trials huggingface dataset:
Male Hormonal Contraceptive Development-ACY-5

The purpose of this research study is to help in the development of male contraception (birth control).

The objective is to conduct a male contraceptive trial in which we will evaluate the suppressive effects of acyline when administered in combination with Testosterone (T) and the progestin depo-medroxyprogesterone acetate (DMPA).

We will be administering combinations of three drugs: Testosterone (T) by gel, Depot Medroxyprogesterone acetate (DMPA) and Acyline to see their effects on sperm production. The T/DMPA/Acyline combination will allow us to determine if the more rapid and complete gonadotropin suppression mediated by the early addition of a GnRH antagonist will accelerate and enhance suppression of spermatogenesis.

In prior studies with testosterone and DMPA these drug, which are hormones, have been found to be safe, and to reversibly suppress sperm counts to zero in about 80% of men. We hope to improve this to 100% of men by adding another drug, Acyline.

Acyline is an GnRH antagonist which blocks the release of LH and FSH from the pituitary. DMPA is approved by the FDA for use as a female contraceptive. The endpoint will be suppression of spermatogenesis to zero (azoospermia) by the end of the treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* Males between 18-55
* In good general health
* With normal sperm counts
* Willing to use an acceptable form of contraception

Exclusion Criteria:

* Men in poor health
* Significant chronic or acute medical illness
* Skin conditions that might interfere with or be exacerbated by testosterone gel
* Known history of alcohol, illicit drug or anabolic steroid abuse
* Abnormal reproductive function
* Participation in a long-term male contraceptive study within past three months
The Clinical Feasibilityof a Multi-modal Photoacoustic/Ultrasonic Imaging System in Rheumatoid Arthritis

New type of imaging method is in demand clinically for early detection and treatment guiding of RA. Photoacoustic imaging (PAI), a hot spot in medical imaging society, which combines the merits of optical imaging and US and has a capacity in morphological, functional and molecular imaging, has shown potential in visualizing superficial organs, including small joints. The investigators developed a multi-modal photoacoustic/ultrasound (PA/US) imaging system, equipped with a handheld 3D PA/US probe, which wass able to provide 3D volume data of dual-wavelength PA imaging of small joints, in addition to real-time 2D PA/US imaging. The investigators plan to recruit RA patients in different disease conditions and healthy volunteers to receive the 2D and 3D PA/US examination on the 2nd and 3rd MCP, PIP joints and wrist joints using this imaging system, and to evaluate the potential clinical role of the imaging system in RA, and its added value to current imaging methods.

The multi-modal PA/US imaging system was built on a high-end commercial US platform, and allowed real-time imaging of grey-scale US imaging, Color-Doppler US (CDUS) imaging and dual-wavelength PA imaging. The PA/US images were acquired using a hand-held probe integrated optical devices and US transducers. 3D volume data of the selected joint of each participant was collected using an automatic scanning device after the dual-modal imaging. The investigators plan to recruit RA patients from the outpatient department of Rheumatology of our hospital, who have been diagnosed as RA by experienced rheumatologists. The patients and healthy volunteers will receive multi-modal imaging examinations using the novel imaging system. The MCP 2 and 3, PIP 2 and 3, and wrist of bilateral hand were chosen for the multi-modal imaging. Conventional US scanning of the joints, including grey-scale US, CDUS, and PDUS, will be carried out by an experienced US operator. Afterwards, 2D and 3D PA/US imaging will be implemented for each joint by the same operator. All of the imaging data will be analysed by the Matlab software.

Eligibility Criteria:
The inclusion criteria

1. The patients were above 18 years-old;
2. The patients were diagnosed with RA according to the American College of Rheumatology (ACR) criteria, and the current clinical state was in-active or relapse;
3. The patients were consent to receive examinations of photoacoustic imaging.

The exclusion criteria

1. The patients had mental disease or other severe diseases, and were not capable of receiving imaging examinations;
2. The patients had strong reaction to laser light.
Whole Genome Sequencing Versus Whole Exome Sequencing for Congenital Diarrhea and Enteropahty

This study will seek to determine if whole genome sequencing (WGS) improves diagnostic rates, and outcomes for congenital diarrhea and enteropathy (CODE) patients. The investigator will enroll 180 patients in a randomized controlled study to either WGS or whole exome sequencing (WES). This study is designed to evaluate whether CODE patients would benefit from WGS guided precision medicine.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic diarrhea lasting greater than 2 months
* Patients with consent from parents or legal guardians
* Biological relative of a patient enrolled in this study.

Exclusion Criteria:

* Chronic diarrhea caused by specific infections, i.e. CMV, Clostridioides difficile
* Chronic diarrhea with necrotizing enterocolitis, short bowel syndrome
* Functional diarrhea
* Patients with previously confirmed monogenic diarrhea
* Patients with poor compliance
Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department

The purpose of this study is to determine if there is a difference between an antibiotic, trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses following incision and drainage.


Eligibility Criteria:
Inclusion Criteria:

* Age 3 months to 17 years
* Single, localized soft tissue abscesses requiring incision and drainage with purulent material obtained
* Diameter of the abscess less than 5cm as measured by the treating physician

Exclusion Criteria:

* Signs of systemic illness or ill-appearing, as determined by the treating physician
* Admission to the hospital following treatment in the Emergency Department
* Known sulfa allergy
* Immunocompromised patients
* Soft tissue abscesses involving the perineum (labia, scrotum, penis, perirectal)
* Previous antibiotic use (for any reason) in the past seven days
* Non-English speaking patients and families
Cardiovascular Toxicity Induced by Antitumoral Drugs: Risk Assessment and Early Diagnosis. CARDIOTOX Registry

The study is multicenter, post-authorization, observational and ambispective

Cardiovascular toxicity produced by antitumoral drugs has a considerable impact in life wellness and prognosis of cancer patients, which can imply the suspension of the desired antitumoral treatment or even risk the patient´s life. The development of a risk score for these patients, as well as specific methodology for early detection of cardiotoxicity would therefore be a great outcome to trigger new strategies for the monitoring of these patients. Currently there is a lack of a clinical score to predict cardiotoxicity risk. Therefore, there is an urgent need to identify new myocardial injury biomarkers and novel imaging parameters for measuring ventricular function that would increase the sensitivity of the traditional methods used for the early detection of cardiotoxicity.

The objectives of the present study are the following:

* Identify the factors related with cardiotoxicity risk produced by antitumoral drugs.
* Assess the utility of clinical, biological and functional parameters for the early detection of cardiotoxicity produced by antitumoral drugs.

The study is a multicenter one, observational and ambispective. We will include all the patients assessed by the Oncology and Haematology Departments in each participant hospital that are about to initiate or are undergoing chemotherapy with any of the drugs specified in the study protocol. Patients will be monitorized during the treatment, undergoing an echocardiography study and a blood sample collection in each clinical timepoint. All these parameters will hopefully shed some light for the development of a clinical risk score as well as identifying new early biomarkers for cardiotoxicity.

The initial follow-up in this phase of the study will be 2 years

Eligibility Criteria:
Inclusion Criteria:

* Patients\> 18 years with indicated antitumor chemotherapy.
* Estimated survival ≥ 6 months
* No oxygen dependence
* No contraindication for taking the study target antitumor agents.
* No exclusion of patients with risk factors or previous heart disease.
* No exclusion of patients with previous cancer, previous antitumor treatment, current antitumor treatment, previous or current radiotherapy.
* No exclusion of patients with previous cardiovascular toxicity

Exclusion Criteria:

* No exclusion criteria.
Targeted Intervention for Bipolar Smokers

The purpose of this research is to develop and test a new type of smoking cessation counseling for individuals with bipolar disorder.

All participants will receive the nicotine patch, an FDA-approved smoking cessation medication, in an open-label fashion. In addition to the nicotine patch, participants will be randomized to receive one of the two types of counseling for smoking cessation. Participants will be in the research study for approximately 18 weeks. The total number of study visits is 15.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are motivated to quit smoking
* Male or female
* 18 years of age or older
* Diagnosed with bipolar disorder according to DSM-IV criteria
* Stable on medication with no significant changes in the last 3 months before enrollment.
* Smoking 10 cigarettes/day for the past 90 days

Exclusion Criteria:

* Healthy volunteers
* Patients not meeting the criteria for the diagnosis of Bipolar Disorder according to DSM-IV criteria
* Not being and being treated with medication for the bipolar disorder
Protocol to Obtain Bone Marrow for Research

Potential donors who are undergoing bone marrow biopsy or bone marrow donation as part of clinical care will be asked by the principal investigator (PI) if they might be interested in donating marrow for this research project. If they are interested, the PI will meet with the prospective donor to review the information contained in the informed consent document and to answer any questions the potential subject may have. Bone marrow aspirates of approximately 5cc will be obtained from the posterior iliac crest of subjects using standard techniques.

The purpose of this study is to determine the mechanisms that regulate human globin gene expression by analyzing the function of cell signaling pathways and the expression of other related genes and their protein products in the bone marrow cells of people without blood diseases. This includes the effects of drugs and other in vitro manipulations of the cells once they are removed from donors. These assays will include, but are not limited to, determinations of DNA methylation status, histone acetylation profiles, DNAse sensitivity, transcription factor binding to DNA, levels of various proteins, messenger RNAs and miRNAs in the cells of the marrow samples. By understanding how this process occurs in people without blood diseases, we hope to to design future treatments for people with diseases such as sickle cell disease and B-thalassemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing diagnostic bone marrow biopsies at the Norris Cotton Cancer Center of DHMC.
* Patients undergoing bone marrow harvesting for autologous bone marrow transplantation.
* Normal donors undergoing bone marrow harvesting for autologous bone marrow transplantation.
* Normal persons over the age of 17 who volunteer to undergo bone marrow aspiration.

Exclusion Criteria:

* Normal volunteers with known allergies to lidocaine (or similar analgesics)or betadine.
"Recovery 4 US" - A Photovoice-based Social Media Program

This study is a randomized trial evaluating "Recovery 4 US", a social media program aimed at the enhancement of community participation and overall recovery of individuals with psychiatric disabilities.This innovative e-mental health program integrates Internet and mobile technologies and is designed to be a self-sustaining recovery-oriented virtual community for individuals living with a disabling mental illness based on the principles of Photovoice.

This study is a randomized trial evaluating "Recovery 4 US", a social media program aimed at the enhancement of community participation and overall recovery of individuals with psychiatric disabilities.This innovative e-mental health program integrates Internet and mobile technologies and is designed to be a self-sustaining recovery-oriented virtual community for individuals living with a disabling mental illness based on the principles of Photovoice.

The "Recovery 4 US" program which includes a mobile phone application and a password protected website, has three main components: 1) receipt of daily hope-inspiring message, paired with a corresponding visual image; 2) creation and viewing of recovery-oriented Photovoice works; and 3) opportunity to attend community events initiated by members of the "Recovery 4 US" community.

The benefits of the "Recovery 4 US" program will be evaluated through a randomized trial with n=60 participants. The study will take place at the Boston University Center for Psychiatric Rehabilitation. Participants will be randomized to the experimental group (provided with a smartphone and access to "Recovery 4 US" application and website) or the control group (provided with a smartphone but without access to the "Recovery 4 US" app or website). We anticipate participation in the program will be associated with reduced loneliness, increased hopefulness, community participation, and overall recovery.

The recruitment goal for this study was amended to n=70.

Eligibility Criteria:
Inclusion Criteria:

* are 18 or older
* have been recipients of services at the BU CPR Recovery Center due to having a DSM-V diagnosis of mental illness, including dual diagnosis (dual diagnosis refers to co-occurring mental illness and alcohol/ substance use disorder) as indicated in their records
* are interested in participating in a social media program
* are fluent in English
* have a basic ability to use a mobile phone

Exclusion Criteria:

* Inability to give full and knowing consent
Research About Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection

Clinically, patients with persistent HR-HPV infection for more than 18 months or HR-HPV infection with CIN2 + need regular colposcopic biopsy to assess the outcome and progression of the disease. A total of 1000 participants with persistent HR-HPV infection (100 cases/center) were recruited from multiple centers, and HPV integration status and vaginal flora diversity were sequenced at baseline, 6th month, 12th month and 24th month, respectively, through prospective cohort studies. And to evaluate the influence of HPV integration status and flora changes on the prognosis of women with persistent HR-HPV infection.

This study aims to: 1) determine the association between HPV integration and natural outcome in women with persistent HR-HPV infection. 2) determine the prognostic value of different HPV integration status in women with persistent HR-HPV infection. 3) determine the relationship between the integration status of different HPV genes in the cervix and the diversity of vaginal flora in women with persistent HR-HPV infection, and its prognostic value in women with LSIL and HSIL.

Eligibility Criteria:
Inclusion Criteria:

* Non pregnant people with sexual history；
* Persistent infection of the same type of HR-HPV for more than 18 months or HR-HPV infection with CIN2 +;
* No history of previous surgery at the cervical site.
* Asexual life, no vaginal medication or flushing before 72 hours of sampling.

Exclusion Criteria:

* Within 8 weeks after pregnancy or postpartum.
* Patients with history of genital tract tumor.
* History of HPV vaccination.
* Previous history of hysterectomy, cervical surgery, pelvic radiotherapy Historical.
* In recent one month, she has received genital tract infection, HPV or other STDs treatment related to the infection of mycoplasma.
* Use antibiotics or vaginal microecological improvement products in recent 1 month.
Remote Monitoring of COVID-19 Positive Outpatients

This study seeks to evaluate how secondary data retrieved from remote physiological monitoring performed during routine outpatient/at-home care periods can allow for the discovery of novel physiomarkers that predict acute deterioration or hospitalization among people testing positive for Coronavirus Disease 2019 (COVID-19).

Most recent research publications and clinical trials have exclusively focused on the hospital and intensive care unit (ICU) care of COVID-19 patients. Few have focused on how to direct care delivered at home, where the majority of coronavirus infected will recover, and how and when to rescue those who are at immediate risk for poor outcomes. To standardize the home monitoring process and offer guidance in this uncharted territory, the researchers have created a method for outpatient management of COVID-19 patients and high suspicion influenza-like illness (ILI) for Emory University Hospital. This includes the newly implemented model of clinics including in-person ambulatory management in the Acute Respiratory Clinic (ARC), the Virtual Outpatient Management Clinic (VOMC), and the Emory COVID-19 Outpatient Remote Monitoring Registry (E-CORMR). Initial analysis of the management system, particularly in risk tier assignment, has shown that assigning risk tiers early can help to identify patients at risk for clinical deterioration. The researchers have also demonstrated symptom profiles and durations of the "typical" outpatient disease course. The E-CORMR was used to create a dashboard for improved management of these frequently complex patients. It was determined after its creation that it could also be used for research purposes to store data collected from physiologic parameters.

The goal of this study is to develop algorithms using secondary data abstracted from remote monitoring devices that were collected within the E-CORMR. The researchers propose to derive robust algorithms through the analysis of that data that identify a potential hospitalization. The findings will not only improve the management of patients with known or suspected COVID-19 but also provide information that allows early intervention on patients at risk of decompensation. This information can then be used by other healthcare systems to care for patients more safely at home, thus reducing the impact of COVID-19 on overburdened acute care settings and preventing poor outcomes.

Eligibility Criteria:
Inclusion Criteria:

* identified to be positive for COVID-19 by Quantitative Reverse Transcription polymerase chain reaction (qRT-PCR)
* demonstrate symptoms of COVID-19
* symptom onset within 7 days
* completed 21 days of remote monitoring with a Medtronic remote pulse oximeter device

Exclusion Criteria:

* none
UCon Treatment of Overactive Bladder (OAB) in Males

UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. This clinical investigation is a randomized, cross-over, single-site, prospective, early feasibility study, which is used to evaluate Ucon with respect to its initial clinical safety and device performance in a small number of males with OAB.

The purpose of the current investigation is to obtain information about the type of stimulation that Ucon provide (time limited vs. urge stimulation), would be the most effective and feasible for the treatment of non-neurogenic OAB symptoms in males.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years of age.
2. Subject is male.
3. Subject is diagnosed with OAB
4. Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation.

Exclusion Criteria:

1. Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the investigation).
2. Subject has a Post Void Residual (PVR) of more than 100 ml or a Bladder Voiding Efficiency (BVE) of less than 75% (measured by uroflowmetry as the ratio of voided volume (VV) and total bladder capacity (VV+PVR)).
3. Subject has an active infection in the genital area incl. skin infections and urinary tract infection.
4. Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.
5. Subject has used antimuscarinics or β3 agonists within 14 days weeks\*.
6. Subject has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function).
7. Subject is enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug study or medical device investigation within four weeks to enrolment.
8. Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
9. Subject has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has radiation-induced damage to the pelvic region.
10. Subject has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
11. Subject does not speak and understand Dutch.

    * If a subject is currently being treated with antimuscarinics or β3 agonists, he is allowed to be included in the investigation, however, a washout period of 14 days is required before baseline can be established.
Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions

The purpose of the research is to determine whether a noninvasive hearing test may be used to predict blood glucose in people with diabetes.

Participation in the study will involve listening to sounds through earphones while blood glucose levels are measured by taking blood samples using a lancet. During the study, blood glucose levels will be increased by drinking a beverage containing sugar.

Up to five visits to the NCRAR will be needed over a six-month period to complete the study. Each visit lasts either two or four hours, and will be scheduled at your convenience. You will be paid $20 for the first 2-hour screening visit and $50 for each 4-hour visit. You will be paid $30 if you are selected to participate in a 2-hour Attention Correlation Test that a sub-set of 10 participants will complete.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diabetes
* Normal hearing
* Hemoglobin A1C of 5.5-8%

Exclusion Criteria:

* Volunteers may not participate if they have peripheral neuropathy

  * visual impairment due to diabetic retinopathy
  * organ failure (kidney, liver heart, or lungs)
  * severe or unstable cardiovascular disease
  * active alcohol or drug abuse
  * schizophrenia
  * bipolar disorder
  * active major depressive disorder
  * active foot ulcerations
  * active viral or other infections such as HIV
  * hepatitis, or pneumonia
  * serious renal
  * cardiac or cognitive dysfunction.