cyrilzakka/clinical-trials huggingface dataset:
Treatment of Post Traumatic Stress Disorder in Patients With Other Mental Illnesses

The purpose of this study is to develop an effective treatment for people with Post Traumatic Stress Disorder (PTSD) along with other mental illnesses.

Despite the progress in treating PTSD in the general population and the elevated prevalence of PTSD in people with severe mental illness (SMI), there are no empirically validated treatments designed for patients with comorbid PTSD. The cognitive behavioral treatment provided in this study may improve knowledge of PTSD, decrease distorted beliefs, reduce PTSD symptoms, and improve quality of life.

Participants are randomly assigned to receive either a cognitive behavioral treatment plus standard care for SMI or standard care alone. The cognitive behavioral treatment incorporates several common features, including psychoeducation, relaxation training, and cognitive restructuring. Standard care for SMI includes medication, case management, and psychosocial treatment. PTSD, psychiatric symptoms, health, quality of life, and substance abuse outcomes are measured. Participants' knowledge of PTSD and beliefs about the world are also measured. Participants are assessed at baseline, post-treatment (16 weeks), and at 3- and 6-month follow-ups.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00494650

Eligibility Criteria:
Inclusion Criteria:

* Post Traumatic Stress Disorder
* New Hampshire definition of SMI plus DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression
* Case management services and contact with a case manager at least twice a week

Exclusion Criteria:

* Alcohol or drug dependence
* Hospitalization or suicide attempt in the past 2 months
Influence of Prenatal and Early Childhood Home-Visiting by Nurses on Development of Chronic Disease

This study is a longitudinal cohort study that follows participants in a randomized clinical trial of a program of prenatal and early child home visiting on maternal and offspring risks for chronic disease.

Addressing the unacceptably high rates of chronic disease and premature mortality among low-income African Americans (AA) is a public health imperative. The proposed study addresses this challenge by building upon decades of follow-up of low-income, primarily AA participants in a randomized clinical trial of the Nurse-Family Partnership (NFP), a program of prenatal and infant/toddler nurse home visiting for low-income mothers with no previous live births. It examines NFP effects on risks for cardiovascular disease (CVD), type 2 diabetes (T2D), and chronic kidney disease (CKD), as well as premature mortality among both mothers and their first-born offspring at offspring age 30. It is the first adequately powered study of a very early intervention to examine risks for chronic disease and mortality, assessing both mothers and their first-born offspring.

Please note that for this section of the longitudinal study, just the outcome measures for 30 years after delivery are being measured. The study team also measured these outcome measures at baselines, 12 years, and 18 years after delivery in other studies, but for this specific study, the time frame for the listed outcome measures is 30 years after delivery.

Eligibility Criteria:
Inclusion Criteria:

* Mothers who participated in a randomized clinical trial of nurse home visiting and their first-born offspring.
* Women \< 29 weeks pregnant --\> No previous live births
* No specific chronic illnesses thought to contribute to fetal growth retardation or preterm delivery
* At least two of the following sociodemographic risk conditions: unmarried, less than 12 years of education, and unemployed

Exclusion Criteria:

* Participants who refused assessments at earlier phases of data gathering.
* Women \> 29 weeks pregnant
* Previous live births
* Possessing chronic illnesses like hypertensive disorders requiring medical treatment, severe cardiac disease, large uterine fibroids.
Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship

The investigators conduct this prospective study to investigate the learning curve of digital rectal examination (DRE) for prostate cancer among internship. The investigators want to know how many DRE are usually needed for internship to be performed in urological practice to obtain a stable DRE accuracy.

Digital rectal examination (DRE) is a basic physical examination in routine practice in Urology. The DRE is a very important daily practice for screen prostate cancer, and each internship in Urology is required to perform this for patients suspected of prostate cancer or benign prostate hyperplasia. However, how many DRE are usually needed for a internship to perform so as to obtain a stable accuracy in daily practice is currently unknown. The investigators thus conduct this prospective trial to investigate the learning curve of DRE among internship.

Eligibility Criteria:
Inclusion Criteria:

* Internship just graduate from the medical school, and agree to attend the study.
* Internship have less than 5 DREs of prostate cancer.
* Patients of any age who are included for prostate biopsy are eligible, the indications for prostate biopsy are as follows: PSA\>4ng/ml, fPSA/tPSA\<0.16, with suspected palpable nodes in the prostate by DRE of attending doctor, suspected mass in prostate detected by ultrasound examination, magnetic resonance imaging, or computed tomography.

Exclusion Criteria:

* Internship who are not willing to attend the study.
* Internship stop doing DRE for continuously 3 months after entering the study.
Following the Use of Gel Prosethetics in Breast Reconstruction

Following placement of silicone breast prosthetics for reconstruction

Patients undergoing breast reconstruction will be followed for outcomes after placement of silicone prostheses

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing breast surgery

Exclusion Criteria:

* Collagen vascular disease, Scleroderma
Topical Imiquimod for Bowen's Disease of the Head and Neck

* Double blinded, randomized, placebo controlled trial of imiquimod for the treatment of histologically proven Bowens disease of the head and neck.
* Null hypothesis: No difference in histologic clearance rates of patients with head or neck Bowens treated with imiquimod versus placebo.
* Outcome: Histologic clearance of Bowens disease at T=14 weeks.

Interventional study Enrolling

Inclusion criteria: Military beneficiaries with histologically proven Bowens disease, located on the head and neck, defined as any area superior to the clavicle and anterior to the posterior triangle of the neck

Exclusion Criteria:

* Previous treatment of biopsied lesion Recurrent lesions from previous biopsy-proven Bowen's disease
* Patients younger than 18 years of age
* Pregnancy
* Immunosuppression, including HIV, transplant patients on immune suppressive medications, cancer patients on chemotherapy, and hematologic malignancies (e.g., lymphoma, leukemia)
* Mucous membrane involvement
* Lesions larger than 2 cm

  * Methods: Pts randomized to treatment group (6 weeks of Mon-Friday Imiquimod to Bowens site) or vehicle group (same treatment regimen). All patients undergo surgical excision (Mohs or simple excision) of site where disease is either visible or was present and tissue examined for histologic evidence of residual Bowens disease

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of Bowen's disease (squamous cell carcinoma in situ), defined as full-thickness keratinocyte atypia and architectural disorder limited to the epidermis, with or without involvement of the follicular unit

  * Located on the head and neck, defined as any area superior to the clavicle and anterior to the posterior triangle of the neck
  * Primary Bowen's disease (first diagnosis)

Exclusion Criteria:

* Previous treatment of biopsied lesion
* Recurrent lesions from previous biopsy-proven Bowen's disease
* Patients younger than 18 years of age
* Pregnancy
* Immunosuppression, including HIV, transplant patients on immune suppressive medications, cancer patients on chemotherapy, and hematologic malignancies (e.g., lymphoma, leukemia)
* Mucous membrane involvement
* Lesions larger than 2 cm
A Study Of Early Markers Of Choroidal Neovascularization

Identify early markers of choroidal neovascularization (CNV) in the fellow eye of a patient with CNV in the other eye due to age-related macular degeneration with the expectation of being able to identify patients in need of intervention.

CNV in one eye and dry AMD in the other

Eligibility Criteria:
Inclusion Criteria:

* Sub-, extra- or juxta-foveal choroidal neovascularization (CNV) or macular scar due to AMD in the non-study eye.
* No CNV or geographic atrophy in the study eye.
* Best corrected visual acuity in the study eye of greater than 20/40 or better than 70 ETDRS letters.
* Sufficiently clear ocular media and adequate pupillary dilatation to permit good quality fundus imaging of the study eye.
* Subjects of either sex, aged 50 years.
* Evidence of a signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
* Willing and able to comply with scheduled visits, laboratory tests, and other trial procedures.

Exclusion Criteria:

* Subjects presenting with any of the following will not be included in the study:
* Evidence of manifest CNV by FA, color photography or ICG angiography in the study eye.
* Any prior treatment for CNV to the study eye (excluding vitamins and AREDS formula).
* Significant media opacities, including cataract, which might interfere with visual acuity assessments, or fundus imaging in the study eye. Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 2 years.
* Presence of other causes of choroidal neovascularization in the fellow eye, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
* Any progressive eye disease other than AMD (eg, glaucoma, diabetic retinopathy) in the study eye.
* Presence of subretinal hemorrhage, serous or hemorrhagic pigment epithelial detachments, subretinal fibrosis or pigment epithelial tears or rips in the study eye.
* Any medical condition that would interfere with the patient's ability to complete the trial.
* Concurrent enrollment in any other observational or interventional clinical study.
* Any treatment with an ocular or systemic investigational agent in the past 60 days for any medical condition.
* Known serious allergies to the dye used in fluorescein angiography or ICG.
Impact of Combined Hormonal Contraceptives on UPA

The purpose of this research study is to determine if taking a birth control pill effects how well an emergency contraceptive pill called Ulipristal acetate (UPA) works. This type of emergency contraceptive is the most effective oral method available. However, this medication is an anti-progestin and most regular forms of birth control contain progestin (a female hormone). It is unknown if taking the two close together may make the emergency contraceptive not work well. The overall goal of this research is to improve the effectiveness of contraception for women and to better counsel women.

Emergency contraception (EC) provides women with an additional line of defense against unintended pregnancy during an act of unprotected intercourse. An antiprogestin, ulipristal acetate (UPA; ellaTM), has emerged as one of the most effective oral options. However, there is currently a lack of information regarding the practical use of UPA. Basic science studies have shown that UPA binds to and prevents progesterone receptor from working, leading to the possible concern that hormonal contraceptives, like the birth control pill, would prevent UPA from working. Ideally, women should start their regular method of birth control soon after EC use but by doing this, they may prevent the UPA EC from working. A woman could just delay starting her regular method of birth control but then she is still at risk for pregnancy.

This proposal has been designed to address this gap in knowledge and will focus on the impact of the birth control pill on UPA's ability to delay ovulation (or the release of an egg). Subjects will undergo a referent cycle UPA only (Cycle 1, 1 month), followed by a washout cycle (Cycle 2, 1 month) and finally UPA with combined oral contraceptives (COCs) dosed 2 days later (Cycle 3, 1 month treatment cycle). The hypothesis is that starting the birth control pill shortly after UPA adversely impacts UPA's ability to delay ovulation.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy women aged 18 to 35 with regular menses (every 21-35 days).
* Normal BMI
* Proven ovulation with a screening serum progesterone of \>3ng/mL
* Willing to use condoms (if sexually active with a male partner), willing to not have sex with men during the study, or have had a tubal ligation (or have a partner who has had a vasectomy) or have a copper intrauterine device (IUD).

Exclusion Criteria:

* Known intolerance or allergy to any of the study medication
* Known metabolic disorders including polycystic ovarian syndrome or uncontrolled thyroid disorder
* Overweight or obese BMI
* Any Centers for Disease Control and Prevention (CDC) Medical eligibility criteria category 3 or 4 for combined oral contraception (COC) use 12.
* Pregnancy, breastfeeding, or seeking pregnancy; recent (8 week) use of hormonal contraception
* Current use of drugs that interfere with metabolism of sex steroids
* Smokers.
Effects of Lacticaseibacillus Rhamnosus LRa05 on Bacterial Vaginosis and Ovarian Function in Women

In this study, Lacticaseibacillus rhamnosus LRa05 was selected as test preparations to observe the clinical efficacy in the intervention trial of combined antibiotic therapy, and to evaluate its effects on the cure rate, recurrence rate and vaginal microbiota of patients with bacterial vaginitis.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 65 years old, sexual activity, premenopausal women;
2. Nugent score for diagnosing BV ≥7;
3. Signed informed consent.

Exclusion Criteria:

1. Mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
2. history of systemic organic disease or psychiatric illness;
3. Planning pregnancy, breastfeeding, menstruation;
4. within 5 days of the onset of the disease, any antibiotics have been used;
5. long-term use of contraceptives or immunosuppressants;
6. Allergic constitution or hypersensitivity to known components of the study drug.
Contingency Management to Reduce Alcohol Use in a Soup Kitchen Sample

Alcohol use and alcohol-related disorders are highly prevalent in soup kitchen users, and this population is overrepresented by minorities and disproportionately affected by alcohol-related morbidity and mortality. Contingency management is a behavioral intervention effective in reducing substance use, but few studies have evaluated the efficacy of contingency management in the context of soup kitchens or homeless programs. The investigators found that contingency management, using a twice weekly testing and reinforcement schedule, had benefits for decreasing drinking in individuals receiving services at a homeless shelter. This study will replicate and extend these earlier findings to a soup kitchen population using more sophisticated alcohol monitoring procedures to better assess the extent of drinking in this group and in response to a contingency management intervention reinforcing submission of negative breath samples. Specifically, 40 hazardous drinkers recruited from a soup kitchen will be randomly assigned to one of two conditions: alcohol monitoring or the same plus reinforcement for provision of daily negative breath alcohol samples. The interventions will be in effect for 3 weeks, and all participants will also wear transdermal continuous alcohol monitors during the intervention period. Objective and subjective indices of alcohol consumption will be evaluated and compared between and within the treatment conditions. This pilot project will provide information regarding the effect size of contingency management reinforcing negative breath samples in an important health disparities group, and results from this study will guide subsequent grant applications focusing on methods to decrease drinking in this underserved population.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18
* frequent soup kitchen users who drink alcohol
* willing to wear transdermal alcohol monitor for 3 weeks
* willing to sign a property transfer form and return SCRAMx equipment

Exclusion Criteria:

* uncontrolled, severe psychopathology and/or severe cognitive impairment
* non-English speaking
* in recovery for pathological gambling
* has a medical condition that would interfere with transdermal alcohol readings
* legal charges pending that are likely to lead to incarceration
Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil

The purpose of this study is to provide sildenafil therapy to patients who completed the A1481244 study for the treatment of PAH, and reside in Brazilian States where Revatio™ is not supplied by Health Secretary, and are judged by the Investigator to derive clinical benefit from continued treatment with Sildenafil. It will be supplied until patient gets access to Sildenafil through Brazilian State Health Secretary from where patient resides.


Eligibility Criteria:
Inclusion Criteria:

* Subject who completed the A1481244 study and are judged by the Investigator to derive clinical benefit from continuous treatment with Sildenafil 20 mg therapy.
* Subject who resides in a Brazilian State where Sildenafil is not supplied by State Health Secretary.

Exclusion Criteria:

* Pregnant or lactating women.
* Current participation in other studies and during study participation.
Examining Endogenous Antioxidant Levels in Well Trained Cyclists

This study will investigate whether increased habitual intake of antioxidant supplements effects the concentration of endogenous antioxidants, the response of antioxidants to exercise, and differences in oxidative damage compared to a non-supplemented group.


Eligibility Criteria:
Inclusion Criteria:

* Male,
* BMI 18.8 29.9 kg/m2
* cycle 3-7 times a week for durations longer than 60 minutes
* cycled for a minimum of 3 years
* accustomed to exhaustive cycling protocols
* healthy (no known cardiovascular or metabolic disease)

Exclusion Criteria:

* answering "NO" to any question on the general health questionnaire would result in exclusion from the study
* current participation in another clinical study
* current or recent smoker (last 30 days)
* prescription or non-prescription of anti-inflammatory use \>30 days prior to the experiment commencing or any other medications that in the opinion of the investigator may interfere with redox signalling
The Efficacy of Periarticular Single Drug Compared With Multimodal Drug Injection in Controlling Pain After TKA

The purpose of this study is to determine the periarticular multimodal drug injection has more efficacy for controlling pain after TKA than single anaesthetic drug injection.

Many studies have to determine the efficacy of periarticular multimodal drug injection or single local anaesthetic drug comparing with placebo for pain controlled in TKA. But in this study would like to determine which one of both drugs are more efficacy.

In multimodal drug injection consist of levobupivacaine, morphine, ketorolac and epinephrine while single anaesthetic drug has levobupivacaine and epinephrine.

Eligibility Criteria:
Inclusion Criteria:

* primary osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
* age 50-85 years old

Exclusion Criteria:

* unable to perform spinal anaesthesia
* history of drug allergies; local anaesthesia, Non-steroidal anti-inflammatory drugs, morphine, epinephrine
* cognitive function impairment
* renal impairment (creatinine clearance \< 30 mL/min)
* liver impairment, gastrointestinal bleeding
CArdioversion of Short Duration Atrial Fibrillation

The study is aimed at testing the hypothesis whether atrial fibrillary rate (AFR), as a measure of atrial electrical remodeling assessed from surface ECG, is predictive of sinus rhythm maintenance after electrical cardioversion.

Earlier studies performed in a retrospective fashion suggested that high AFR exceeding 350-360 fibrillations per minute is an independent predictor of AF relapse after cardioversion, particularly in patients with duration of AF episode not exceeding 30 days, however this hypothesis has not been tested in a prospective study.

CASAF is an observational study that will enroll patients with short duration (\< 30 days) AF admitted for electrical cardioversion. Admission ECG will be extracted in a digital format and processed off-line for estimation of AFR. AF relapse will be assessed during 6-weeks long follow-up period during which ECG control will be scheduled at week 1 and 6.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent AF verified by at least one ECG recording prior to the index admission
* Known onset of symptoms within 30 days from index admission.
* Sinus rhythm ECG within 30 days prior to the index admission If onset of symptoms is unknown.
* If duration of the present AF episode \>48 hours then thromboembolic risk should be minimized by either verifying that the patient is adequately anticoagulated according to the hospital routine or TEE performed to verify the lack of contraindications for electrical cardioversion.
* Echocardiography at any time since first onset of AF to verify the lack of significant valvular disease.
* Age older than 18 years.

Exclusion Criteria:

* AF due to reversible cause or significant valvular heart disease
* Treatment with class I or III antiarrhythmic drugs within five half-lives of their elimination period. No amiodarone treatment within six months before admission
* Prior ablation of AF
* Unability to verify onset of symptoms within 30 days prior to the index admission
Use of Preoperative and Postoperative Antimicrobial Treatment

In this study, patients undergoing ear surgery (cochlear implantation, stapedotomy, tympanoplasty) will be randomized to one of two antibiotic treatment groups.

One group will receive a single treatment with an antibiotic at induction

The other group will receive the single intravenous treatment, plus a one week course or oral antibiotic

1. Patients will be asked to participate in the study.
2. Randomization
3. Surgery
4. Follow-up at 1 week, 1 month patients will be asked if they filled their prescription, took the medication as prescribed, experienced any symptoms such as rash, diarrhea, nausea,.. Further the wound will be inspected for any signs of infection. Patients will also be asked if they had noticed discharge, pain, pulsating sensation
5. Follow-up at three months, 1 year and 2 years - patients will again be asked for any signs of infections or necessary visits with their doctor due to infections

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study
* Undergoing standard ear surgery (Stapedotomy, cochlear implantation, tympanoplasty and tympanomastoidectomy)

Exclusion Criteria:

* multiple allergies to antibiotic substances
* therapy with an antibiotic substance within the last 6 weeks
* prior radiation to the head and neck patients undergoing revision surgery
* Any use of post-operative antibiotics (oral, intravenous, topical) for reason which do not include surgical site infection