cyrilzakka/clinical-trials huggingface dataset:
Combination Statin, Acetylsalicylic Acid and Dutasteride Use in Prostate Cancer

The purpose of this study is to assess whether there is any interaction between statins, acetylsalicylic acid (ASA) and dutasteride on protection from prostate cancer, the development of high grade prostate cancer, or lower urinary tract symptoms.

A review of data collected from REDUCE (REduction by DUtasteride of prostate Cancer Events) study participants will be performed. Data required for the analysis includes: ethnicity, prostate specific antigen (PSA) levels, prostate volumes, presence of diabetes, concomitant medication use (for statin and ASA), prostate biopsy results at 2 and 4 years, body mass index (BMI), digital rectal exam (DRE) results, family history of Prostate Cancer and benign prostatic hyperplasia (BPH) outcomes: urinary retention, international prostate symptom score (IPSS), urinary tract infections (UTI)s.

The association of drug interactions with prostate cancer will be explored by using a multivariate logistic regression model including all possible interaction terms between dutasteride, ASA and statins (i.e. statin+ASA+dutasteride, statin+ASA, dutasteride+statin, dutasteride+ASA). Any interaction term found to be insignificant ( i.e. p\>0.05) will be removed from the model. If a statistically significant interaction term is identified, the study cohort will be stratified by drug use, and the relative risk (RR)of prostate cancer among the different drug users will be reported. To control for potential confounders, a multivariate regression model will be constructed adjusting for age, family history of prostate cancer, DRE results and BMI.

Eligibility Criteria:
Inclusion Criteria:

* Participants who received dutasteride or placebo and had at least one post-baseline prostate biopsy

Exclusion Criteria:

* Participants not taking concomitant statins or ASA
Intervention to Increase Physical Activity in Older Adults Using Citizen-science and Modern Technology

To develop and implement a physical activity promotion intervention for older adults with or without chronic disease living in an urban environment.

The World Health organization recommends that all adults should aim for 30 minutes of moderate physical activity on at least five days of the week. The importance of physical activity for promoting heath is complicated when considering inactive older adults and chronic conditions. A problematic cycle emerges where physical inactivity increases the likelihood for developing chronic conditions, and, in turn, many chronic conditions are associated with symptoms that make physical activity more difficult.

The investigators aim to develop and implement a physical activity promotion intervention for older adults with or without chronic disease living in an urban environment that considers individual, interpersonal and environmental factors and makes use of a citizen-science approach and modern PA-monitoring devices.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older
* Living within or \<5km from Wetzikon (Zurich area)
* Understand and speak German
* Number of repetitions in the 1-min sit-to-stand test below the 75th percentile compared to the Swiss population (age and sex-specific reference values)

Exclusion Criteria:

* Symptomatic / unstable cardiovascular disease
* Cardiac surgery within one year
Retrospective Database Study of Real World Abilify Outcomes in Major Depressive Disorder (MDD)

To examine the differences in health care utilization and costs between MDD patients on adjunctive aripiprazole therapy and MDD patients on other augmentation therapies.


Eligibility Criteria:
Inclusion Criteria:

* ≥1 fill for an augmentation therapy medication from Table 1 during the identification period of 01 January 2005 - 30 November 2008.
* 12 months of continuous enrollment with medical and pharmacy benefits each before the index date (pre-index period) and after the index date (post-index period).
* ≥1 medical claim with a primary International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis for MDD (296.2x, 296.3x, 311.xx) during the pre-index period.
* Age ≥18 years as of the year of the pre-index period.

Exclusion Criteria:

* No pharmacy claims for atypical antipsychotics, mood stabilizers, anxiolytics, anticonvulsants, or stimulants, during the pre-index period.
* No medical claims with primary or secondary diagnoses for non-MDD episodic mood disorders or schizophrenia during the pre-index or post-index periods.
A Study of Dose Escalation of IBI321 in Patients With Advanced Solid Tumors

This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
2. Patients with advanced solid tumors who had failed standard treatment.
3. Male or female subjects ≥18 years and ≤75 years.
4. At least one measurable lesion per RECIST version 1.1
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
6. Life expectancy of ≥ 12 weeks.
7. Adequate hematologic and end organ function

Exclusion Criteria:

1. Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, targeted therapy, or immunotherapy.
2. Failure to recover from adverse events from the most recent anti-tumor
3. Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
4. Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs.
5. Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
6. Pregnancy, lactation, breastfeeding.
Lung Ultrasound to Diagnose COVID-19

Covid-19 (English acronym meaning coronavirus disease 2019) is an emerging infectious disease caused by a strain of coronavirus called SARS-CoV-2. The current pandemic has resulted in a significant number of admissions in the emergency room (ER) due to suspicion of COVID-19 infection. Use of lung ultrasound is standard practice to diagnose acute respiratory failure in ER. Recently, typical lung ultrasonographic characteristics of COVID-19 disease has been described. During the COVID-19 pandemic, the use of this tool could be of interest in order to allow an early, simple and reliable triage in patients with suspected COVID-19 infection admitted in ER. In addition, the visualization of early signs in specific areas could be a predictive marker of the severity of the disease. The objective of this project will be to study the association between the signs on lung ultrasound and the result of RT-PCR in patients with suspected COVID-19 infection in the ER.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted to Emergency Room for suspicion of COVID-19 infection with has a SARS-CoV-2 RT-PCR test and for whom the emergency doctor decide to perform a lung ultrasound

Exclusion Criteria:

* patients \< 18 years of age or under guardianship or curators,
* pregnancy
* poor echogenicity due to the presence of an acoustic barrier (pneumothorax, subcutaneous emphysema, etc.)
* patients with a suspected or proven acute lung disease (pneumonitis, acute respiratory distress syndrome (ARDS))
* chronic interstitial lung disease
* patients who will refuse to give their consent.
The Impact of Placental Factors on Fetal Intrauterine Growth and in Intrauterine Programming of the Metabolic Syndrome

Genetic and environmental factors are believed to play a major role in intrauterine growth and intrauterine programming. We intend to study genetic factors such as Telomere homeostasis, senescence, genomic instability and the presence of Genomic copy number variations in placental tissue from pregnancies complicated with Intrauterine growth restriction(IUGR), Gestational and pre gestational Diabetes, placentas from IVF pregnancies and from normal pregnancies. We also intend to assess these factors in cord blood and maternal blood.

Based on the previous data from our group as well as other laboratories, we postulate that there is a correlation between impaired telomere homeostasis, senescence genomic instability and intra-uterine programming in placentas and in fetuses exposed to suboptimal intrauterine conditions such as hypoxia or hyperglycemia. Improved understanding of the mechanisms that produce the genomic changes in IUGR placentas and their influence on later risks of developing the metabolic syndrome should provide basis for future research that might lead into improved outcome of IUGR fetuses.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Intrauterine growth restriction
* A diagnosis of Gestational diabetes
* A diagnosis of pre gestational Diabetes
* IVF pregnancy

Exclusion Criteria:

* chorioamnionitis
* meconium stained amniotic fluid
* A request of the patient for Cord blood retrieval for preservation
.Exercise and Follow-up After a Mastectomy

A Randomized Control Trial (RCT) on the effect of education and Exercise on women after a mastectomy found positive results in range of motion of the affected shoulder and quality of life in the intervention group.

Background: Breast cancer ranks highest in incidence and mortality among females and ranks second when both genders are combined. Lebanon has the second highest rate of breast cancer worldwide for the 35-39 age group and the highest in the 40-49 age group. Mastectomy often results in deceased shoulder and arm mobility, and decreased Quality of Life.

Objective: The objective of this study was to assess the effect of an educational program of therapeutic exercises on the quality of life and functional ability in women after a mastectomy Methods: Sixty women undergoing mastectomy were randomly assigned to an intervention and control group. The intervention group received extensive teaching pre-surgery education as well as training on therapeutic exercises. Follow up phone calls to the Intervention group were made to assure that the exercises were being done. Both groups were visited at home at four and eight to obtain the outcome variables. The Breast Cancer Patient Version was used to asses quality of life and the "Goniometer" was used to assess the range of motion of the affected shoulder.

Eligibility Criteria:
Inclusion criteria included:

* women between 35 and 55 years of age
* diagnosed with breast cancer
* scheduled for modified radical mastectomy. .

Exclusion Criteria included:

* Women who were pregnant,
* not able to communicate,
* had co-morbidities that affected their QoL
Michigan Men's Diabetes Project

The investigators propose to develop a training for male peer leaders facilitating diabetes self-management education and support (DSMES) to specifically encourage conversations regarding beliefs that affect men's health and to allow modeling of alternative views and perspectives that allow for successful disease management to be framed as competence and strength. Given that the life expectancy for Black men in the US is 71, the investigators hypothesize that targeting men in earlier stages of type 2 diabetes (T2D) will assist greatly in facilitating healthy aging and improving diabetes-related health outcomes later in life.

Based on the investigators previous work, the long-term goal of our research is to determine the most effective, practical, and sustainable approach to provide DSMES to older Black men. The objective is to examine the relative effectiveness, feasibility, and acceptability of a peer-leader DSMES intervention for Black men with T2D. To accomplish this, the investigators will engage in a developmental phase and a validation phase \[pilot randomized control trial (RCT)\]. The RCT will be conducted with 60 Black adult male residents of metro Detroit, Michigan. Participants will be randomized to a control group or the tailored peer-leader diabetes self-management support group (PLDSMS). All participants will receive DSME with a certified diabetes care and education specialists. Only participants randomized to the PLDSMS group will also receive an additional 6 weeks of DSMS led by the peer leaders. The investigators hypothesize that 1) participants in the PLDSMS group will have improved outcomes (A1c, blood pressure, weight, diabetes distress, self-management behaviors, etc.) over the control group, and 2) an evaluation of measures will confirm efficacy of the PLDSMS.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 55 or older
* Black/African American
* Diagnosis of type 2 diabetes for a six-month duration or longer.

Exclusion Criteria:

* Non-ambulatory
* Serious health conditions (morbid obesity and severe symptomatic heart disease, visual impairment, renal failure, and peripheral neuropathy)
* Psychiatric illness (severity requiring hospitalization)
* Cognitive deficit
* Serious diabetes complications (e.g. blindness) that would impede meaningful participation.
Sexual Health of Obese Men Before and After Bariatric Surgery.

Compare Male Health Sexual Questionnaire (MHSQ) before and after bariatric surgery to assess the sexual health of the obese men with a recommended and exhaustive tool. There are few data that evaluate the sexual health of this population.

The sexual dysfunctions are more commonly in the obese men population. For example, erectile dysfunction is more than twice as common as in the general population. However, the data on sexuality in the broad sense are rarer. The latter are in favor of an inconsistent improvement and use the Brief Male Sexual Function Inventory. The MHSQ is now recommended by the French Urology Association to evaluate more fully male sexuality. Its relatively recent validation explains the few studies referring to. The investigators believe that one of the major determinants of sexual health in obese men is the self-image.

The investigators will submit to the patients the male heath sexual questionnaire, the Beck Depression Inventory (BDI) and the Multidimensional Body Self Relations Questionnaire - Appearance Scales (MBSRQ-AS) and collect weight, BMI and age during the classic follow up. The data will be collected during the preoperative assessment as well as 6 months and 12 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Any male patient eligible for bariatric surgery, the indication of which was decided at a multidisciplinary consultation meeting.
* not opposed to research.
* benefiting from social security cover.

Exclusion Criteria:

- inclusion criteria not satisfied
Pharmacokinetic Drug-Drug Interaction Study

The purpose of this study is to determine whether benznidazole and E1224 should be administered concomitantly in patients with Chagas Disease as not enough data are available. This study aims to assess cross interactions of these two compounds.

Benznidazole and E1224 are intended to be administered concomitantly in patients with Chagas disease. Thus, an in vivo interaction study in healthy volunteers may be justified as the two drugs are intended to be administered concomitantly in patients and no in vivo nor in vitro data are available.

In addition both interactions (potential for benznidazole to interact on the pharmacokinetic (PK) of E1224 and potential for E1224 on the PK of benznidazole should be studied.

Benznidazole t1/2 is quite short (12 h) whereas E1224 t1/2 is very long (more than 200 h). Therefore it was chosen to study the interaction of E1224 at steady-state while interaction of benznidazole after single dose appears more appropriate instead of a classical randomized cross-over design.

Eligibility Criteria:
Inclusion Criteria:

1. Male healthy volunteers 18 to 45 years of age;
2. Light smokers (less than 5 cigarettes per day) or subjects who are non-smokers;
3. Male subjects with a body weight of at least 50 kg and a body mass index (BMI) calculated as weight in kg/height (in m2) from 18 to 28 kg/m2 at screening;
4. Able to communicate well with the Investigator and research staff and to comply with the requirements of the entire study;
5. Provision of written informed consent to participate as shown by a signature on the volunteer consent form;

Exclusion Criteria:

1. Who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected HIV, hepatites B virus (HBV) or hepatites C virus (HCV) infection;
2. Who has positive diagnosis of T. cruzi infection indicated by Conventional serology;
3. With any clinically significant abnormality following review of pre-study laboratory tests, vital signs, full physical examination and 12-lead ECG;
4. Who forfeit their freedom by administrative or legal award or who were under guardianship;
5. Unwilling to give their informed consent;
6. Who have a positive laboratory test for Hepatitis B surface antigen (HbsAg), or anti-HIV 1/2 or anti- HCV antibodies;
7. Who have a history of allergy (serious or not), allergic skin rash, asthma, intolerance, sensitivity or photosensitivity to any drug;
8. Who are known or suspected alcohol or drug abusers (more than 14 units of alcohol per week, one unit = 8 g or about 10 mL of pure alcohol);
Acute Effects of Cycling Dual-task in Parkinson´s Disease.

Taking into account the process of functional and cognitive evolution that patients with Parkinson's disease experience throughout the pathology, the objective of this study is to evaluate the acute effects of aerobic exercise in forced cycling performed with lower limbs and freecycling of upper limbs combined with cognitive stimuli on attention, exploration skills, and short-term motor skills in people with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease
* Present stage between I and III on the Hoenh and Yarh scale
* Being able to move autonomously

Exclusion Criteria:

* Moderate-severe cognitive impairment (Mini-mental test \> 24)
* Comorbidity that discourages the practice of physical exercise and that allows performing all scheduled assessments
* Severe visual alterations that prevent the development of the session
Melatonin and Glucose Tolerance Among Individuals With a Variant of the MTNR1B Gene

The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants of the melatonin receptor 1B gene will be evaluated. The following will be done at 0 and 3 months:

* OGTT
* questionnaires about sleep and activity
* Actigraph
* Anthropometry
* Blood pressure

http://www.sciencedirect.com/science/article/pii/S1550413116301607

Eligibility Criteria:
Inclusion Criteria:

* signed informed concent
* Known genotype for MTNR1B from the Botnia-ppp study
* Age 18-75 years

Exclusion Criteria:

* Diabetes
* Positive GAD-ab
* Sever dysregulated hypertension
* glaucoma
* severe coronary heart disease or arrythmias
* previous or ongoing severe ventricle or duodenal ulcer
* psychosis or anxiety disorder
* regular use of sleep pills, antidepressants or neuroleptics
* creatinine \> 130 µmol/L
* elevated liver enzymes (ASAT, ALAT, ALP, GT, bilirubin) \> 3 times reference value
* inability to sign informed concent
* other factor with according to the physician may affect treatment or results.
* participation in other clinical study
* allergy to melatonin or other substance in the capsule
* hereditary galactose intolerance or glucose/galactose malabsorption
* intention to become pregnant
A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL)

This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients with previously untreated B-CLL. The length of the controlled portion of the study is two years. The study will be conducted at investigative sites in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Have signed a written informed consent
* B-CLL diagnosis
* Rai Stage 0, I, or II
* Previously untreated
* Be able to watch and wait for approximately 8 months following submission of blood (or tissue) while Id-KLH is being manufactured

Exclusion Criteria:

* Anti-leukemia treatment prior to beginning immunization
* Anti-leukemia treatment other than Id-KLH during immunizations
* Prior malignancy (excluding basal cell carcinoma and cervical carcinoma in situ)
* Pregnant or lactating
* Patients with known autoimmune disease (including previously treated autoimmune hemolytic anemia or immune thrombocytopenia)
* Participation in any other clinical trial in which an investigational agent is administered
Clinical Study Spartan COVID-19 V2 System (Canada Alternate)

This multicentre prospective study will enroll a sufficient number of patients to afford approximately 30 positives and \> 30 negatives (as determined by the SOC - Comparator method) in the United States and/or Canada. One to three sites in the Canada will participate over an approximate 6-week enrolment period. The actual enrolment period will be dependent upon prevalence of Covid-19, and site set up. Once positives sample size is achieved, expected SARC-CoV-2 negative subjects will be permitted.

Once subjects are consented and recruited for the study, up to three (3) study-specific nasopharyngeal samples for each patient will be collected by trained operators at the clinical site: a single SOC swab, and two (2) Spartan swabs where the second swab is optional and used when the first Spartan swab test does not produce a positive or negative result ("inconclusive").

The first swab sample will be tested at the clinical site according to standard of care protocols currently in place for the sites' nasopharyngeal swab-based SARS-CoV-2 RT-PCR testing. The second nasopharyngeal sample will be tested at the site using the Spartan COVID-19 v2 System. A third, optional nasopharyngeal sample, if collected, will be tested using the Spartan COVID-19 v2 System only when the test conducted with the second nasopharyngeal swab does not produce a positive or negative result.


Eligibility Criteria:
Inclusion Criteria:

* Suspected SARS-CoV-2 infection by a healthcare provider, and whose first symptoms presented ≤ 7 days of onset; or
* Suspected SARS-CoV-2 infection from the same household of a person who tested positive for SARS-CoV-2 using an authorized test; or
* Known positive SARS-CoV-2 infection using an authorized test, and whose first symptoms presented ≤ 7 days of onset; or
* Expected negative SARS-CoV-2 infection - individuals with no symptoms or a recent negative result by an authorized test.

Exclusion Criteria:

* Vulnerable populations (e.g., women with pregnancy, institutionalized individual) as deemed inappropriate for study by the site investigator
* Individuals with self-reported nosebleed within 24 hours of presentation