cyrilzakka/clinical-trials huggingface dataset:
Optimizing a Multi-Modal Intervention to Reduce Health-Risking Sexual Behaviors: Component Selection

The goal of this project is to evaluate the components of the app-based intervention Mission Wellness to reduce health-risking sexual behaviors (HRSBs; e.g., condom non-use, multiple sexual partners) in active-duty members of the US Military to improve their sexual and reproductive health (SRH) and readiness to serve. Following the multiphase optimization strategy (MOST) framework, factorial component selection experiments (CSEs) will be conducted to evaluate which five experimental intervention components (i.e., Narratives, Skills, Scenarios, Future, and Risk) elicit the greatest improvements in the outcomes of interest given key constraints.

Negative SRH outcomes (e.g., sexually transmitted infections \[STIs\], unintended pregnancy, STI-related cancers) reduce human performance and undermine military readiness. Service members face unique challenges to maintaining SRH during their military service. HRSBs (e.g., multiple sexual partners, unprotected sexual behavior) offer potential intervention targets to improve SRH. Electronic-health interventions are cost-effective and dynamic, and have the potential to reach millions of users as part of an overall strategy for individual behavior and systems change. In civilian populations, e-health interventions have demonstrated success in reducing HRSBs. However, effective HRSB-prevention interventions must consider the specific values, mission, and context of military populations and settings. The MOST framework is used to develop highly effective, efficient, and economic behavioral interventions that is particularly well suited to be used in this context.

This project aims to address this problem by delivering an optimized app-based prevention intervention package ready for evaluation via a subsequent randomized controlled trial (RCT). The specific purpose of this project is to determine which component(s) should be included in the packaged app-based intervention Mission Wellness for US service members based on their effects on the outcomes of interest (i.e., improved knowledge, motivation, and behavior skills related to SRH and reduced HRSBs) in no more than 25 minutes of content. The components tested in the factorial CSEs include: Narratives; Skills; Scenarios; Future; and Risk. Each component has two levels: "on" (included) or "off" (not included). Main and interaction effects of components will be measured to determine the components constituting the packaged intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Age 17 or older,
2. currently serving as active duty in the US military, and
3. willing to participate in all study activities if eligible and enrolled

Exclusion Criteria:

1. Does not meet eligibility criteria,
2. unable to read, speak, or comprehend English, or
3. unable or unwilling to give informed consent
Effect of Udenafil on Spermatogenesis

Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects on semen characteristics.

Safety Study in male subjects with no or mild ED (erectile dysfunction)

Eligibility Criteria:
Inclusion Criteria:

* No or mild ED (erectile dysfunction) willing \& able to provide 2 semen samples without the use of PDE-5 inhibitor or other excluded medication or devices on 2 separate days during screening and at Weeks 12 \& 26
* BMI (body mass index) between 19 and 31 kilogram/meter squared

Exclusion Criteria:

* New onset coronary artery disease within last 3 months, history of myocardial infarction or cardiac surgical procedure within last 6 months or sudden cardiac arrest
* Nitrate medications for angina pectoris
* Used of anti-arrhythmic drug treatment or device
* Congestive heart failure
* Uncontrolled diabetes
* Stroke or transient ischemic attack (TIA) within last 6 months
* Bleeding disorder or history of GI bleeding within last 12 months
* Cancer chemotherapy
* History of alcohol or drug abuse
The EarLens Contact Hearing Device (CHD) Spectrum Study

The EarLens System is an assistive hearing device that is intended to provide amplification for the treatment of patients with sensorineural hearing impairment. The purpose of the proposed study (Extended Investigation under the Continued Access Policy) is to continue to allow access to the investigational medical device with the collection of device utility and clinic process-flow data while the marketing application is under review at the FDA.

The study is designed to obtain observational data and as such no primary safety or efficacy endpoints or sample sizes are computed. Information gathered about device utility and clinic procedures from the physician, audiologist as well as subject questionnaires will be analyzed for the purpose of optimizing the process flow in different types of practice settings. A subset of relevant safety and efficacy measures from the Definitive Study (DEN150002) will be collected and adverse events will be tracked and reported per applicable regulations.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 85 years.
2. Mild to severe hearing impairment between 125 to 8000 Hz.
3. Asymptomatic of retro-cochlear lesions or cleared of retro-cochlear lesion by MRI.
4. No significant conductive hearing impairment;

   * No more than a 10 dB air-bone gap at 3 of 4 tested frequencies (500, 1000, 2000, or 4000 Hz)
   * Normal Type A tympanometry (indicating normal mobility of the tympanic membrane and middle ear bones)
5. Greater than or equal to 50% on clinical speech discrimination demonstrating an ability to benefit from amplification;
6. Able and willing to commit to the travel and time demands of the study (available for 5 months or longer) and able to comprehend and comply with the study materials and instructions
7. Experience with 1 or 2 air conduction hearing aids or previously evaluated for use with hearing aids;
8. Fluent speaker of American English due to use of American English study materials

Exclusion Criteria:

1. The Subject must not have known or active medical issues that would preclude having a hearing device, including:

   * an abnormal TM (deemed perforated, inflamed or has a dimeric or monomeric area, or in any other way abnormal);
   * an abnormal middle ear or a history of prior middle ear surgery other than tympanostomy tubes;
   * an ear canal anatomy that prevents the physician from seeing an adequate amount of the tympanic membrane.
   * an anatomical configuration of the external auditory canal that prevents satisfactory placement of the TMT
   * a history of chronic and recurrent ear infections in the past 24 months;
   * a rapidly progressive or fluctuating hearing impairment;
   * diagnosed with having a compromised immune system which may impact the tissue of the auricle or ear canal, such as keratosis obturans, ichthyosis, eczema of the auricle or ear canal, or received radiation of the head ever or chemotherapy for cancer within the last six years.
2. Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
Prostate Health Index for Prostate Cancer Diagnosis

Prostate biopsies are the gold standard for prostate cancer (PCa) diagnosis. They are performed according to the results of the measurement of prostate-specific antigen (PSA) in the serum of patients with PCa suspicion. More than half of the prostate biopsies reveal eventually negative because of the poor specificity of prostate-specific antigen assay. The Prostate Health Index (PHI) is a new diagnostic tool that has been described as a good predictor of prostate biopsy outcome. No large study has been performed so far in France. This study aim to evaluate Prostate Health Index diagnostic performances in a large multicentric French cohort of patients undergoing prostate biopsies because of clinical and/or biological suspicion of prostate cancer.

Prostate Health Index will be measured in patients directed to prostate biopsies according to usual practices. Inclusion of 400 patients within 6 months in 12 French centers is expected. The ability of Prostate Health Index to predict prostate cancer at biopsy will be evaluated in terms of intrinsic and extrinsic diagnostic performances including sensitivity, specificity, predictive values, diagnostic accuracy, area under receiver operating curves and decision curve analyses.


Eligibility Criteria:
Inclusion Criteria:

* Man ≥ 18 years old
* Addressed for prostate biopsy because of serum total Prostate Specific Antigen ≥ 4 ng/mL and/or abnormal digital rectal examination and/or first degree familial history of prostate cancer
* Agreeing to participate to the study

Exclusion Criteria:

* Personal history of positive prostate biopsy (evidence of prostate cancer)
* Personal history or evidence of prostate cancer based on clinical data (highly suspicious digital rectal examination (≥cT3) and/or serum total PSA ≥ 20 ng/mL and/or evidence for lymph node or bone metastases (retroperitoneal lymph nodes, bone lesions ...)
* Evidence for synchronous non-prostate cancer (current active treatment)
* Adult protected by law
The Effectiveness of the Microfracture Technique in the Meniscal Healing

Meniscus injuries are a very common cause of knee pain. The meniscus is a semilunar fibrocartilage structure found on the medial and lateral sides of the knee. The meniscus serves to absorb impact and protect the articular cartilage during weight-bearing activities, joint stability, proprioception, and nutrition. This has a significant effect on knee biomechanics.

After the menisci are injured, the biomechanics of the knee change so that degenerative changes occur more frequently in the tibiofemoral compartment. Improvement of tibiofemoral arthrosis after meniscectomy surgery has been demonstrated in several long-term clinical studies. With increasing awareness of the importance of the meniscus in knee biomechanics, various meniscus repair techniques have been developed. In addition, several adjuvants for healing have been proposed to enhance meniscus healing. However, a study showed the meniscal repair failure rate increased from 22% to 24% at 5 years.

Study found the healing rate of meniscus repair, which was accompanied by ACL repair, had a greater healing rate, 93% vs. 50%. Hemarthrosis that occurs after bony tunneling during ACL reconstruction provides a fibrin clot and an environment rich in factors that promote healing of the newly repaired meniscus. The fibrin clot provides the structural foundation for meniscus healing. Transmission factors, such as fibronectin and growth factors, are also present.

Microfracture is a common procedure used for the treatment of damage to the articular cartilage in the knee. This procedure is used to stimulate the production of fibrocartilage in areas of injured cartilage. Microfractures are performed by creating 1 or more small channels (1 to 3 mm in size) that pierce the subchondral bone and release bone-forming components into the joint. Microfractures serve to promote the formation of fibrocartilage over damaged cartilage. Research in 2016 used an animal model (Capra hircus) to investigate the effectiveness of the microfracture technique on meniscus tear healing rates. They found significant healing in meniscal repair accompanied by microfracture technique (65% vs 12%).

However there is still not enough research regarding the efficacy of microfracture in meniscal healing, especially among Indonesian. Therefore, the investigators aim to investigate its efficacy.


Eligibility Criteria:
Inclusion Criteria

1. Patients with meniscus tears
2. The patient underwent meniscus repair surgery using arthroscopy.
3. Have an MRI examination before and after surgery within 6 months post-surgery.

B. Exclusion Criteria

1. Patients with meniscus tears in the white-white area
2. The patient underwent meniscus repair surgery without using arthroscopy
3. The patient did not perform an MRI examination before after surgery within 6 months post-surgery.
Safety Study of Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies

In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile.

MGCD265 belongs to a new class of drugs with anticancer potential, known as tyrosine kinase inhibitors. MGCD265 was shown to slow down the growth of human cancer cells in mice. Clinical studies are being pursued to evaluate the safety of MGCD265 in cancer patients.

In this study, MGCD265 is orally administered on a daily basis to patients with advanced malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Advanced metastatic or unresectable malignancy that is refractory to standard therapy and/or existing therapies are not likely to achieve clinical benefit, and/or the patient declines to receive standard treatment such as chemotherapy.
* Evaluable disease;
* Last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy;
* Recovery from the adverse effects ≤ grade 1;
* Acceptable ECOG status 0, 1, or 2;
* Life expectancy greater than 3 months following study entry;
* Adequate laboratory values;
* For patients enrolling in the four expansion cohorts:

  * NSCLC patients must meet criteria for MET and/or Axl expression or,
  * HNSCC patients must meet criteria for MET and/or Axl expression or,
  * NSCLC patients must meet criteria for amplification of the MET gene locus, defined MET mutations, or rearrangements involving the AXL or MET gene locus or;
  * Patients with tumor types such as HNSCC, papillary renal carcinoma, gastric adenocarcinoma, and other solid tumors must meet criteria for amplification of the MET gene locus, defined MET mutations, or rearrangements involving the AXL or MET gene locus

Exclusion Criteria:

* Uncontrolled concurrent illness;
* History of cardiovascular illness;
* QTc \> 470 msec (including subjects on medication);
* Left ventricular ejection fraction (LVEF) \< 50%;
* Immunocompromised subjects;
* History of bone marrow transplant;
* Lung tumor lesions with increased likelihood of bleeding;
* Symptomatic or uncontrolled brain metastases;
* Unable to swallow oral medications or with pre-existing gastrointestinal disorders.
Repetitive Transcranial Magnetic Stimulation in Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts

Even in the absence of a preliminary diagnosis of Attention Deficit Hyperactivity Disorder, symptoms of attention deficit, hyperactivity and cognitive impairment are common in cocaine addicts.

Several factors indicate that repetitive transcranial magnetic stimulation might be a strategy to aid in the treatment of symptoms of attention deficit hyperactivity disorder and cognitive function in cocaine addicts.

However, up to current days there have been no studies evaluating the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on neurocognitive performance of individuals suffering from the ADHD.

Transcranial Magnetic Stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.

The treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 4 consecutive weeks. Each session lasts up to 30 minutes.

Side effects include scalp discomfort and mild headache. No anesthesia is required.

Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results.

The present technique has never been employed in previous studies, but risks are insignificant.

Eligibility Criteria:
Inclusion Criteria:

* Cocaine Dependence Syndrome (alone or in combination with alcohol and/or nicotine dependence with symptoms of ADHD, according to the criteria of the DSM-IV-R (APA, 2000), as well as through a structured clinical interview (SCID-1/P v 2.0)
* Minimum age of 18
* Maximum age of 40
* 20 days or less abstinence.
* any psychopharmacological treatment other than clonazepam (4 mg/day)

Exclusion Criteria:

* Metallic Cerebral Implant
* Pacemakers
* History of Severe Brain trauma or injury
* Organic Brain Disease
* Previous neurosurgery
* History of seizures
* Epilepsy
* Severe Somatic Disease
* History of other actual or past psychiatric diagnostics
* Clinically significant changes in laboratory test
* Any psychiatric or neurological disorder other than Cocaine Dependence with symptoms of ADHD
* Psychotic depression
* Suicidal propensities
To Evaluate Success of Cement Treatment of Spinal Compression Fractures

Patients with vertebral compression fracture will be treated cement injection into the spine and monitored using standard evaluations.

Patients with vertebral compression fracture will be diagnosed and treated with balloon kyphoplasty. Pain and functional status will be assessed at baseline, 1-, 12-, and 24-months post-operatively using VAS pain scale, Oswestry Disability Index, and SF-36.

Eligibility Criteria:
vertebral compression fracture
Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics

The purpose of this study is to investigate the feasibility of conducting a multicomponent lifestyle intervention research study within the UAB Family Medicine Clinic at Highlands and to obtain preliminary data on the effectiveness of the adaptive treatment strategies being investigated to produce improvements in insulin resistance. This study is a Sequential Multiple Assignment Randomized Trial (SMART) with initial randomization groups of individualized nutrition counseling vs. individualized exercise counseling. Note that these initial nutrition or exercise interventions are NOT intended to produce significant weight loss. Participants that do not sufficiently improve their insulin resistance score after 8 weeks will be re-randomized to 2nd stage interventions of either receiving dietary counseling for weight loss or receiving a prescription for metformin. We will collect data on the effectiveness of the intervention to improve insulin resistance/metabolic health in the family medicine clinic as well as potential predictors or moderators of treatment success.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Any race or ethnicity
* BMI \>27 kg/m2
* Presence of 1 or more mild-to-moderate obesity-associated metabolic complications (i.e., Stage 1 Obesity)
* Prediabetes, type 2 diabetes (see exclusion criteria for additional details), metabolic syndrome, dyslipidemia, hypertension, non-alcoholic fatty liver disease
* Stable medication type and dosage for ≥3 months

Exclusion Criteria:

* If type 2 diabetes,
* Currently prescribed metformin or prescribed within previous 3 months
* HbA1c concentration of \>12%
* Using exogenous insulin
* Pregnant or lactating within the past 6 months or trying to become pregnant
* Prescription for weight loss medications within the past 3 months
* Severe obesity-related complications that require immediate and more intensive clinical therapy (e.g., pharmacotherapy and/or bariatric surgery) as determined by study physician and/or referring practitioner at UAB Family Medicine Clinic.
* History of kidney disease that may increase the risk of lactic acidosis with metformin.
* Currently prescribed the following medications that may increase the risk of lactic acidosis with metformin: acetazolamide (Diamox), dichlorphenamide (Keveyis), methazolamide, topiramate (Topamax, in Qsymia), or zonisamide (Zonegran).
* Does not have a life-sustaining medical implant such as a pacemaker.
Register Kardialer Computertomographie

The aim of this Heidelberg Cardiac CT Registry (Register kardiale Computertomographie) is to assess the diagnostic and prognostic perfomance of cardiac CT exminations in a real-world patient population.

Anthropometric data, medical history and results of the CT examinations are collected in a database in order to adressing various scientific questions.

Eligibility Criteria:
Inclusion Criteria:

• Subjects referred for cardiac CT examination by their physician

Exclusion Criteria:

• none
Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection

Background:

Patients who undergo laparoscopic surgical resection of colorectal cancer may experience various post-operative symptoms (e.g., pain, nausea and vomiting, and anxiety) and limitation of daily activities (e.g., walking capacity). There is also a risk of post-operative complications and a prolonged hospital stay due to complications. Patients who underwent surgical resection may have experienced chronic pain, anxiety/depression, or diminished quality of life. The physical, psychological, and functional aspects of patients' disorders imply the necessity of multidisciplinary care, including complementary or traditional medicines such as acupuncture. This study aims to assess whether acupuncture treatment, combined with an enhanced recovery program after surgery in an inpatient care setting is effective than only an enhanced recovery program after surgery.

Objective:

To assess the effectiveness and safety of acupuncture combined with an enhanced recovery program after surgery to reduce postoperative symptoms and improve functional recovery and the patients' quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective laparoscopic surgery of colorectal cancer resection (right hemicolectomy, left hemicolectomy, anterior resection with primary anastomosis, and low anterior resection with loop ileostomy for fecal diversion)
* Patients aged 18 to 75
* American Society of Anesthesiologists Grade 1 to 2
* Eastern Cooperative Oncology Group Grade 0 to 2
* Written informed consents

Exclusion Criteria:

* Pregnancy
* Inflammatory bowel disease
* Comorbidities that may affect outcomes of surgery (e.g., chronic kidney disease, chronic liver disease, cardiopulmonary failure, and diabetes with complications)
* Resection of other organs for radical removal of colorectal cancer
* Patients requiring enterolysis due to previous history of abdominal surgery
* Obstructive colorectal cancer
* Metastatic colorectal cancer
* Cognitive impairment that may affect the patient's ability to complete the outcome assessments
* Previous history of stroke
* Previous history of sensitive reaction to acupuncture
* Patients unable to cooperate with acupuncture treatments
* Pacemaker implantation
* Previous history of epilepsy
* Patients who have received Korean medicine treatments (acupuncture, moxibustion, cupping, or herbal medicine) within 2 weeks
* Patients who have participated in other trials within 3 months