cyrilzakka/clinical-trials huggingface dataset:
Biomarkers in First Episode Schizophrenia

This study will identify and evaluate relevant biomarkers and structural brain imaging for understanding potential biological illness related mechanisms in medication-naïve subjects with early psychosis before and after initiation of antipsychotic medication

It is currently unknown whether deterioration early in the course of psychotic illness represents medication toxicity or the natural course of the illness. The study will help clarify this issue in observing 70 schizophrenic patients before and after they are prescribed an antipsychotic via standard of care.

In addition, schizophrenia is a heterogeneous disorder and a putative brain-derived neurotrophic factor (BDNF) deficit, while possibly a common pathway, may not fully capture the biological diversity-the supplemental biomarkers will allow us to perform a more comprehensive assessment of factors contributing to clinical course. Taken together analysis of these biomarkers in relation to clinical course and in relation to healthy subjects will inform us about biological mechanisms contributing to illness onset, effects of antipsychotic medication on these mechanisms, and the predictive value of the biomarkers for clinical course. This information will provide the foundation for future early intervention trials targeting biological mechanisms utilizing a personalized medicine approach.

The baseline visit for 70 schizophrenic patients and 70 healthy age and gender matched controls consists of structural and functional MRI in addition to a blood draw for biomarkers including BDNF, inflammation markers, DNA, oxidative stress, and folate status and additionally a salivary cortisol sample collection. Biomarkers and imaging will be repeated after 8 weeks of antipsychotic treatment in patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Ages 15-40 years
3. Schizophrenia, any subtype or Schizophreniform disorder
4. Sufficient proficiency in English or Spanish to complete assessments (US)

Exclusion Criteria:

1. Major depression by the Diagnostic and Statistical Manual of Mental Disorders IV criteria
2. Calgary Depression Scale for Schizophrenia (CDSS) score of 7 or greater.
3. Clinical Global Assessment of Severity of Suicidality of 3 (moderate) or greater.
4. Serious suicide attempt within three years
5. Treatment with an antipsychotic or antidepressant within the last six months
6. Active alcohol or other substance abuse or dependence within one month
7. Unstable medical illness
Quantitative Neuromuscular Ultrasonography in Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis (ALS) is a progressive and fatal neurological disease. Nonspecific symptoms lead to a delay in the diagnosis, only confirmed by the electrophysiologic study.

Objectives.

1. To establish the diagnostic value of ultrasonography in ALS.
2. To evaluate the rate of muscle and nerve degeneration by ultrasonography in patients with ALS.
3. To check the relationship between ultrasound, clinical variables and functional tests in patients with ALS.

Methods. A longitudinal observational study in a consecutive sample of patients diagnosed with ALS will be realized. All the patients will be examined 3 times during 6 months and capabilities associated with ALS and muscle strength will be assessed. Bilateral and cross sectional ultrasonography of several muscles and also median and tibial nerves will be performed. All the images will be processed and analyzed for obtaining morphometric variables (muscle thickness and nerve area) and textural ones (echogenic variation, entropy, homogeneity, textural contrast and correlation). Frequency of twitches will be also recorded. After longitudinal study, a survival study will be performed in relation to functional and sonographic variables.


Eligibility Criteria:
Inclusion Criteria:

* Definite ALS.

Exclusion Criteria:

* Primary Lateral Sclerosis (PLS)
* Other forms of motor neuron disorders.
Benefit of DAA Therapy in HCV Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia

Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%. The objective of this study was to investigate the impact of DAA therapy on cryoglobulin clearance in patients with HCV-associated MC.

We focused on HCV patients with or without HIV with MC who had at least one cryoglobulin level assessment before and after DAA therapy and investigated the impact of DAA therapy on cryoglobulin clearance.

Eligibility Criteria:
Inclusion Criteria:

* hepatitis C virus (HCV) infected patients
* symptomatic or asymptomatic mixed cryoglobulinemia
* coinfected or not with HIV
* treated by direct-acting antiviral (DAA) treatment
* at least one cryoglobulin measurement before and after DAA

Exclusion Criteria:

-
First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study

The non-invasive bladder emptying device (NIBED) is a handheld medical device that is applied to the penis during urinating to aid bladder emptying in urinary retention patients with increased residual urine volume.

This pilot study primarily seeks to determine the safety of the NIBED. Secondary objectives are to assess the efficacy of the NIBED, which is defined as the ability of the medical device to aid or improve bladder emptying, i.e. leads to less residual urine compared to not using the NIBED.

During the intervention, the study participant will urinate with and without the NIBED. Safety variables such as penile pain, penile lesions and hematuria will be recorded. Efficacy will be assessed by measuring voided volume, residual volume, voiding time and urine flow rate.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Age 18 years or older
* Sex: male
* Diagnosed with underactive bladder (UAB) (confirmed with urodynamic testing)

Exclusion Criteria:

* Acute urinary tract infection
* Patients on anti-coagulants (exception Aspirin)
* Penile pain (NPRS score \>2)
* Pain during voiding (NPRS \>2)
* Penile lesions (NRS score \>2)
* Hematuria \>2+
* Mechanical subvesical obstruction (confirmed by cystoscopy) (exception BPO)
* Transurethral resection of the prostate (TURP) less than three months before visit 2
* Penile abnormalities (Buried penis, Peyronie's disease, skin lesions)
* Asensitive bladder (no sensation of bladder fullness)
* Shy bladder
* Indwelling transurethral catheter
* Inability to understand and follow the study protocol
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Participation in another interventional clinical trial within 3 months prior to visit 2 or planned participation during the trial
* Lacking capacity for consent
Natural History Study of Retinitis Pigmentosa Type 11

Observational study of patients with retinitis pigmentosa type 11

Natural history study with clinical examination every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of retinitis pigmentosa caused by a disease-causing mutation involving the PRPF31 gene
* Or disease-causing mutation involving the PRPF31 gene without the clinical diagnosis of retinitis pigmentosa

Exclusion Criteria:

* Under 18 years
* Other types of retinitis pigmentosa
Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors

The purpose of the study is to determine the effect of fluvastatin on penile arterial blood flow and erectile function in patients with arteriogenic ED and cardiovascular risk factors.

Physiology of erection is mainly dependent on endothelial NO-production with consecutive activation of guanylate-cyclase. Pleiotropic effects of statins are well known regarding the increase of endothelial function. Thus, activation of endothelial NO-synthase could raise the activation of guanylate-cyclase with a consecutive relaxation of smooth muscle cells in the penile arteries and the corpus cavernosum leading to an improvement of erectile function. Therefore, statins are supposed to be effective in the treatment of erectile dysfunction, especially in patients with cardiovascular risk-factors with underlying endothelial dysfunction.

The effect of fluvastatin on penile blood-flow and erectile function in patients with arteriogenic erectile dysfunction and cardiovascular risk factors will be determined in a cross-over design. Patients were either treated with fluvastatin-sodium 80mg or placebo for 8 weeks. After a wash-out of 4 weeks, treatment will be switched (placebo / fluvastatin-sodium). Penile blood flow measurement and assessment of erectile function with the IIEF-5-score and the KEED-score will be performed at baseline, after 8 weeks of treatment, after 4 weeks wash-out and after cross-over treatment (8 weeks).

Eligibility Criteria:
Inclusion Criteria:

* male
* age \> 18 years
* arteriogenic erectile dysfunction (penile blood flow - peak systolic velocity\<30cm/s, diastolic velocity\<5cm/s)
* two or more cardiovascular risk factors (smoking, hypertension, hyperlipoproteinaemia, family history of atherosclerosis, oral treated diabetes mellitus with a HbA1c\<7%)
* stable course of disease without expected changes in medical treatment during the next 3 months
* written informed consent
* no statin-treatment so far

Exclusion Criteria:

* known hypersensitivity or anaphylaxis against a statin
* active liver disease or unclear increase of transaminases, cholestasis or myopathy
* acute cardiovascular event (myocardial infarction, stroke, PTCA, vascular surgery) within 3 months before randomization
* clinical signs of heart failure or reduced left ventricular function
* current treatment with lipid lowering drugs
* insulin dependent diabetes mellitus or orally treated diabetes mellitus with a HbA1c-value \>6.9%
* erectile dysfunction due to hormone disorders
* known malignant tumor
* known disposition to priapism
* patients with morphological changes of the penis (i.e. deviation) or penis-prosthesis
* current treatment with anticoagulants
* current treatment with immunosuppressive drugs, phenytoin, erythromycin, gemfibrozil or nicotinic acid derivates
* absence or inability of written informed consent
Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer

This study will evaluate whether patients who are intolerant and discontinue anastrozole due to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking letrozole

This is a multi-center prospective non-randomized single arm, open label trial in postmenopausal HR positive early breast cancer patients who experience grade 2-3 arthralgia-myalgia while on anastrozole, resulting in the discontinuation of anastrozole. After a 2-3 week period without any aromatase inhibitor treatment, eligible patients will initiate letrozole treatment at a dose of 2.5mg per day for a duration of 24 weeks. If a patient has breast cancer recurrence or is intolerant to letrozole during the 24 week period, the drug will be discontinued.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women with HR+ early stage breast cancer at the time of initial diagnosis. For study purposes, postmenopausal is defined as:

   * Age ≥ 50 y and amenorrheic for 12 or more months.
   * Age ≥ 50 y and amenorrheic for 3 or more months after receiving adjuvant chemotherapy.
   * Age \< 50 y and amenorrheic for 12 or more months.
   * Prior bilateral oophorectomy.
   * Prior hysterectomy and has postmenopausal levels of FSH, LH, and estradiol as per local institutional standards.
   * Age \> 55 y and prior hysterectomy.
2. Patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study entry when given as adjuvant treatment for HR+ early stage breast cancer due to grade 2-3 (NCI-CTCAE V3) arthralgia-myalgia.
3. Hormone receptor-positive tumors as defined by institutional standards.
4. ECOG performance status of 0, 1, or 2
5. Consent to participate in the trial. -

Exclusion Criteria:

1. Postmenopausal women with HR+ metastatic or locally relapsed breast cancer excluding chest wall recurrence with no evidence of systemic disease.
2. Recent history of pain associated with non-traumatic bone fracture.
3. Pain requiring chronic use of analgesics (due to any reason).
4. History of rheumatological disease except osteoarthritis.
5. Prior hormonal therapy with AIs other than anastrozole.
6. Systemic hormone replacement therapy (HRT) less than 4 weeks before study entry other than Estring®, Vagifem® or low dose estrogen vaginal cream.
7. Concomitant disease which significantly affects quality of life.
8. Patient unable to complete self administered questionnaire.
9. Patients unable to sign consent form.

Other protocol-defined inclusion/exclusion criteria may apply
A Brain Imaging Study of Opioid (Morphine) and Non-opioid (Ketorolac) Conditioning Effects

Healthy right-handed volunteers aged 21 to 50 needed for a research study of the effects of morphine and ketorolac on brain activity in response to pain stimuli as measured by functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET). Study will be conducted on six separate days not requiring an overnight stay in the hospital.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female adults, aged 21-50
2. No contraindications to fMRI scanning
3. Within 15% of normal BMI
4. Right handed (dominant hand is right hand)
5. Have taken an opioid drug at least once in the past (for example, after a surgery)

Exclusion Criteria:

1. Current or past history of major medical, neurological, or psychiatric illness
2. Women who are pregnant or breast feeding, have gone through menopause, or have irregular menstrual cycles (length of cycle must be within 26 to 32 days)
3. Contraindications to morphine administration:

   * i) Hypersensitivity to morphine or other phenanthrene-derivative opioid agonists (codeine, oxycodone, etc.), morphine salts, or any component of the product
   * ii) Concomitant use of other CNS depressants including antihistamines or alcohol
   * iii) History of drug or alcohol abuse
   * iv) History of head trauma
   * v) History of liver problems
   * vi) Pre-existing respiratory conditions (ex. COPD, asthma)
   * vii) Current use of any drugs that interact with morphine
4. Contraindications to ketorolac administration

   * i) Allergic-type reaction, or urticaria in response to exposure to aspirin or other NSAIDS
   * ii) Concomitant aspirin or NSAID use
   * iii) Hypersensitivity previously demonstrated to ketorolac tromethamine or to any product component
   * iv) Peptic ulcer disease (active or history), or other gastrointestinal problems
   * vi) Current use of any drugs that interact with ketorolac (ex. heparin/warfarin)
   * vii) History of bleeding disorder
   * viii) Low body weight, under 50 kg
5. Contraindications to fMRI scanning (including cardiac pacemaker, metal implants, claustrophobia, pregnancy)
6. Contraindications to either of the emergency medications (Ondansetron or Narcan)
7. History of head trauma
8. High blood pressure (\>140 systolic, \>90 diastolic)
9. History of impaired urinary elimination
10. Major kidney problems, bleeding problems, severe dehydration, or recovering from a recent surgery (within past year).
11. Instability of responses to experimental pain (see Study Procedures Section)
12. History of asthma
13. History of diabetes
14. Liver Function Test results greater than 2.5 times the upper limit of normal (ULN) at Screening
15. History of smoking (past or current)
16. Use of psychotropic drugs, hormone treatments (including hormonal birth control) within 1 year
17. Non-fluent speaker of English
18. Positive urine drug screen (i.e. positive on any of the 10 measures tested, including cocaine, marijuana, opiates, amphetamines, methamphetamines, phencyclidine, barbiturates, benzodiazepines, methadone, and tricyclic antidepressants)
Evaluation of the Impact of Mobile Phone Messages on ART and PMTCT Adherence in Mozambique

Mobile phone SMS are increasingly used to promote positive health behaviour with an aim to improve health outcomes. However, robust data on the efficacy of SMS on health seeking behaviour and patient outcomes in resource-limited settings is sparse. The SMSaude study aims to assess whether regular SMS-reminders improve retention on antiretroviral therapy (ART) and prevention of mother to child transmission of HIV (PMTCT) programmes in Mozambique.

SMSaúde is a multisite randomised clinical trial of HIV-infected adults on ART and HIV-infected pregnant women in six clinics in Maputo Province, Mozambique. Eligibility criteria include: currently residing in the province; no plans to move for 12+ months; have own cell-phone; literate; 8-28 weeks pregnant (PMTCT cohort); on first line ART and on ART for \>15 days (ART cohort). Patients were interviewed for eligibility, and then randomized (1:1). SMS reminders are sent to the intervention group using software that picks up the patient's next appointment from the electronic patient database. Primary outcomes tested were improved retention in ART care and uptake of all PMTCT services.

Eligibility Criteria:
Inclusion Criteria:

* On ART for \>15 days (for ART only)
* Live in province and plan to stay for 12+ months
* Have cell phone
* Literate

For PMTCT (in addition to above criteria):

- pregnant between 8-28 weeks

Exclusion Criteria:

-
Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients

First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.

First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125. Patients will proceed through a screening period, treatment period, and follow-up period of approximately 4 months' duration. There will be 4 dose cohorts including active drug and placebo dosing.

Eligibility Criteria:
Inclusion Criteria:

* HCV-positive
* Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin

Exclusion Criteria:

* Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg)
* Inadequate bone marrow, liver, and renal function
* Treatment with any IFN (interferon)-based or other experimental or antiviral therapies within 30 days
* Other significant medical diseases
* Known alcohol or drug abuse within the past 12 months
Identification of Elderly Patients in Need of Palliative Care by Family Physicians

In the last decades, the number of people living with chronic diseases had increased, mainly due to the aging of the population. Such chronic, progressive, life threatening and burdening diseases, play an important role in this new era of palliative care.

Despite the growing scientific and social interest in palliative care, there is still a delay in the identification of patients with palliative care needs. This leads to a late integration in a palliative care network and consequent deprivation of the major advantages of an early and progressive integration.

The aim of this study is to evaluate the role of palliative care training and the use of a structured tool, in the identification of the elderly population in need of palliative care by family physicians. And also to conduct a prevalence study to further the knowledge about how many elder people in primary care have the need of a palliative care approach.

The study consists of two phases:

1. Randomized trial with General Practitioners (GP) to determine the role of two different training programs and a structured tool in the identification of geriatric patients with palliative care needs.
2. Cross-sectional, analytical study of the prevalence and patterns of geriatric patients with Palliative Care (PC) needs, managed in primary care in Portugal's Center Healthcare Administrative Region.

Eligibility Criteria:
Inclusion Criteria:

* GPs (fellows and specialists) from Center Healthcare Administrative Region

Exclusion Criteria:

* Previous palliative care training.
* Refuse to participate
Olmesartan Comparison to Losartan in Hypertensive Subjects

This study will evaluate the efficacy and safety of the FDA approved blood pressure medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged \> 18 years who are not institutionalized and have signed informed consent.
* Mean cuff seated diastolic blood pressure (BP) must be \> 95 mmHg and \< 115 mmHg and a mean cuff seated systolic BP must be \< 180 mmHg when measured at two consecutive qualification study visits during the placebo run-in phase.
* The difference in mean cuff seated diastolic BP must be \< 7 mmHg between two consecutive qualification study visits during the placebo run-in phase.

Exclusion Criteria:

* Subjects with type 2 diabetes mellitus with an HbA1c ≥ 9.5% at Screening.
* Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of olmesartan medoxomil and losartan potassium, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic (with the exception of non-insulin, dependent type 2 diabetes mellitus with HbA1c \< 9.5% at Screening), hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
* Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or heart failure within the last 12 months.
* Subjects with any history of New York Heart Association Class III or IV congestive heart failure (CHF). A history of New York Heart Association Class I or II CHF may be exclusionary at the discretion of the Investigator.
* Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
* Subjects with clinically significant cardiac conduction defects, including second or third degree atrioventricular (AV) block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.
Evaluation of Effectiveness of Virtual Reality-based Dispatcher Assisted Cardiopulmonary Resuscitation Training

This study aims to compare the effect of conventional cardiopulmonary resuscitation (CPR) training and CPR training with added virtual reality (VR) on trainee self-efficacy.

This study aims to compare the conventional cardiopulmonary resuscitation (CPR) training program (HEROS CPR training program) with the HEROS VR (virtual reality) CPR training program to which the newly developed VR curriculum was added. The experimental group is the HEROS VR training group, and CPR training is conducted for approximately 60 minutes for 6 to 8 trainees per training. At the start and the end of the training, students are taught about cardiac arrest, recognition of emergency situations, and reporting to 119 by watching VR, and in the middle part, they practice chest compressions by watching conventional HEROS video. The control group is the existing HEROS training group. To control variables, the number of trainees per training was limited to 6 to 8, and the existing video-based CPR training was implemented. The investigators will conduct a Modified Basic Resuscitation Skills Self-Efficacy scale survey before and after training to compare the difference in the improvement of trainees' self-efficacy evaluation of CPR after CPR training in the HEROS VR curriculum and the existing HEROS curriculum.

Eligibility Criteria:
Inclusion Criteria:

* Non-medical personnel aged 18\~65

Exclusion Criteria:

* Who have received CPR training within the past 1 year.
* For whom it is difficult to wear the VR equipment due to a history of side effects or problems such as head trauma.