cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Lithium and It's Effect on Clinically Localized Prostate Cancer

Laboratory testing has suggested that lithium may decrease the incidence of certain types of cancer, including prostate cancer. Additional research has suggested that lithium decreases prostate cancer tumor size over time. This study will investigate the effect of lithium on men with prostate cancer.

As lithium has been shown in an in vitro model to suppress cellular proliferation, and suppress tumor growth in an in vivo xenograft model, we propose to determine its effect on prostate cancer cells in human patients undergoing radical prostatectomy. In this pilot study we plan to assess the toxicity of lithium administration in patients prior to radical prostatectomy. This will include any clinical toxicity as well as any increase in intra-, peri- or postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent form.
* Subjects with histologically confirmed local adenocarcinoma of the prostate who have elected to proceed with radical prostatectomy as primary curative therapy.
* Subjects having no prior administration of lithium or lithium containing medications within 90 days of study enrollment.
* Subjects \>/= 18 years of age.
* ECOG (Eastern Cooperative Oncology Group) performance status of \</= 1.
* Adequate renal function defined as GFR (Glomerular Filtration Rate) \>/= 50 mL/min.
* Use of adequate contraception
* ECG (Electrocardiogram) within normal limits.
* Subjects must agree not to take any new vitamin supplements or herbal remedy during the study period.
* Subjects must be able to safety take lithium carbonate for at least 4 weeks before scheduled prostatectomy.

Exclusion Criteria:

* Subjects who have received any investigational medication within 30 days of first lithium dose.
* Subjects currently receiving, or who have had previous hormonal, chemotherapy or radiotherapy for prostate cancer.
* Subjects with known brain metastases.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to lithium carbonate.
* Uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.
Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

The purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.

Subjects will be expected to attend 7 office visits for an individual duration of participation of 28 to 40 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Current wearer of biweekly/monthly replacement multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 months.
* Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
* Able to wear contact lenses within the available power range with a near ADD of +0.75 D to +2.50 D in each eye.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Currently pregnant or lactating.
* History of amblyopia, strabismus, or binocular vision abnormalities.
* Habitual Oasys MF contact lens wearers or daily disposable contact lens wearers.
* Monovision contact lens wearers and wearers of contact lens in one eye only.
* Other protocol-defined exclusion criteria may apply.
Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about nutrition-related changes that identify biomarkers related to cancer. It may also help doctors predict a woman's risk of developing breast cancer.

PURPOSE: This laboratory study is looking at nutrition-related biomarkers in predicting breast cancer risk in women.

OBJECTIVES:

* To complete characterization of metabolic serotypes based on the metabolome, and to adapt these profiles for human epidemiological studies.
* To determine the extent to which metabolic profiles that are reflective of or independent of long-term caloric intake predict breast cancer risk in nested case-control studies.
* To identify critical serum metabolites.

OUTLINE: Laboratory studies, including metabolome profiling by high performance liquid chromatography; and small molecule identification by mass spectroscopy, are performed on previously collected blood samples.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Confirmed breast cancer that was diagnosed at least 2 years after blood sample collection (case)

    * No prior diagnosis of cancer
  * Healthy participant (control)
* Enrolled in the Nurses' Health Study
* Banked blood samples available
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Laser Therapy for Patients With Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease that has detrimental effects on connective tissue and other organs. The musculoskeletal system is one of the most affected systems in this group of patients including the temporomandibular joint. The most common symptoms when muscle involvement in SLE are muscle atrophy decreased muscle strength and myopathy. SLE activity and long-term corticosteroid use are thought to be responsible for these symptoms, thus, SLE patients are accepted to be at higher risk for temporomandibular joint disorders (TMD). Low-level laser therapy(LLLT) is frequently used in the treatment of TMD due to its pain relief and anti-inflammatory effect. Thus, in this study, LLLT has been used to evaluate this treatment modality on the chewing function and pain values of SLE patients with myogenic TMD.


Eligibility Criteria:
Inclusion Criteria:

* Having myogenic temporomandibular joint disorder,
* Following a stable medical regime,
* Showing minimum pain intensity of 50 mm on the visual analog scale.

Exclusion Criteria:

* Having concurrent systemic diseases,
* Using antimalarial drugs,
* Wearing removable prosthesis,
* History of facial trauma.
Single and Multiple Ascending Dose Study of TD-8236 by Inhalation

This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 3 parts: Part A is a single ascending dose (SAD) study in healthy subjects, Part B is a multiple ascending dose (MAD) study in subjects with stable, mild asthma, and Part C (Biomarker) is a multiple dose study in subjects with stable, moderate-to-severe asthma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 - 60 years old
* Willing and able to give informed consent and comply with the study
* Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
* Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
* Pre-bronchodilator FEV ≥ 70% predicted for MAD cohorts and \>40% predicted for biomarker cohorts
* Treatment with inhaled corticosteroids with or without long acting beta agonists
* Additional inclusion criteria apply

Exclusion Criteria:

* Positive for hepatitis A, B or C, HIV or tuberculosis
* Clinically significant abnormalities of laboratory evaluations
* Have abnormal ECG measurements
* Any sign of respiratory tract infection within 6 weeks of screening
* Have a current bacterial, parasitic, fungal or viral infection
* Uses or have used tobacco or nicotine-containing products within 6 months prior to screening
* Additional exclusion criteria apply
Supplementation With Omega-3: Mechanism of Action

This is a trial of two marketed fish oil supplements, one with a high EPA:DHA ratio and the other with a high DHA:EPA ratio, to examine differential effects on platelet function, blood pressure, and fasting triglyceride levels.

Observational studies have shown that fish consumption is associated with a lower risk of cardiovascular disease, and clinical trials have demonstrated that fish oil nutritional supplementation is associated with improvement in cardiometabolic risk factor profiles including fasting triglycerides and blood pressure. However, the mechanisms of action of fish oils are not well understood. Specifically, the effects of different compositions in terms of the ratio of the fatty acids EPA and DHA are not known. We are proposing a pilot and feasibility study of fish oil nutritional supplementation in 40 healthy adult participants with two different commercially available fish oil (high EPA/DHA ratio, high DHA/EPA ratio, sample of 20 per group) with the hypothesis that 4 weeks of supplementation with fish oil results in differential changes in platelet function, blood pressure and fasting triglyceride levels . We will also bank blood and urine for future mechanistic studies. This pilot study will allow us to collect preliminary data for definitive mechanistic studies of the effects of fish oil supplementation and to demonstrate the feasibility of this protocol.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 20-75 years of age.
* Participant of the Principal Investigator's prior studies studies who have agreed to be contacted for future studies.

Exclusion Criteria:

* Current user of fish oil supplements
* Current user of statins
* Allergy to fish or seafood products
* Diagnosed/treated diabetes mellitus
* Using aspirin or NSAIDS or other "blood-thinning medication"
Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

1. Ruptured saccular aneurysm confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling
2. External ventricular drain in place
3. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fisher scale
4. WFNS grade 2, 3, or 4

Exclusion Criteria:

1. Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm
2. Angiographic vasospasm prior to randomization
3. Evidence of a cerebral infarction with neurological deficit
COVID-19 Serological Status of Hospital Staff Working or Not in the COVID-19 Sector

Hospital staff, on the front line in the COVID-19 crisis, have many questions about the risk that they have been infected with this potentially fatal virus. These questions of course primarily concern caregivers working in sectors dedicated to COVID-19 patients, whether they are resuscitating or not, but also those in non-COVID-19 sectors, or even staff without direct contact with patients. In addition, depending on the suddenness and intensity of this "COVID-19 wave", these personnel have been more or less trained and sometimes exposed due to the dire lack of protective equipment. In some countries such as Great Britain, this has resulted in significant absenteeism, a source of deepening the shortage of caregivers.

This proportion of contaminated caregivers has not been evaluated on the whole of French territory. Studies from other countries suggest figures ranging from 1.5% in China to 20% in Italy. It is therefore impossible to rely on such variable data to have a reliable estimate.

Since june 2020, all staff in French health establishments could benefit a serological test.

Thus, in this epidemiological study, we propose to rely on this institutional serological screening to describe the link between seroconversion of hospital staff, regional intensity of the epidemic, and sectors of activity (COVID-19 sectors, non-COVID-19 caregivers , non-COVID-19 non-caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Hospital staff from Argenteuil, Belfort, Dijon and Limoges hospitals.
* Age ≥ 18 years old
* Participation agreement

Exclusion Criteria:

* Protected persons
* Refusal of participation
Efficacy of Spontaneous Laughter in the Postoperative Treatment of Children

The purpose of this study is to determine the efficacy of laughter therapy in children to improve postoperative, evaluating the intensity of postoperative pain, anxiety and hospital stay.

The therapeutic efficacy of laughter is supported in several research which have shown to have preventive and therapeutic effects that contribute to a better quality of life. In addition, laughter can optimize strategies to increase pain tolerance and combat stress, reducing the negative impact such as increased blood pressure, decreases simultaneously perfusion of organs not needed for the motor function, increased metabolism rates cell with increased serum cortisol and increased risk of infections. Nevertheless the upswing in research on these effects, there is still a necessity to have evidence-based medicine as most of the available studies are limited by various problems such as lack of objectivity in the assessment and measurement, distinction between laughter and mood, establishment dosing therapies (frequency and time).

The aim of our study is to determine the efficacy of spontaneous laughter in children to improve postoperative pain, anxiety and length of hospital stay.

Methods: A controlled, randomized, open label trial with an experimental group exposed to the conventional pain treatment with laughter therapy; 2 control group, a group with accompaniment without causing the laughter of children to control the effect of a companion instead of the clown and a conventional treatment group to contrast with experimental group.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients between 6 and 14
* I hospitalized with uncomplicated surgical procedure
* Minimum period of hospitalization of 48 hours
* Patients with informed consent letter signed by parents or guardians
* In patients older than 10 years, a letter of agreement

Exclusion Criteria:

* Endocrinopathies carriers, cancer, abnormalities of central nervous system immune disorders patients.
* Patients treated with both topical and systemic steroids
Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis

This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2 study evaluating the safety and tolerability of NCX 4251 (fluticasone propionate nanocrystal) Ophthalmic Suspension 0.1% QD and BID for the treatment of acute exacerbations of blepharitis. The study will be performed in two sequential dose escalating cohorts.

The study is designed to select the dose(s) of NCX 4251 to advance into the next stage of development, and to assess the safety and tolerability of NCX 4251 Ophthalmic Suspension.


Eligibility Criteria:
Inclusion Criteria:

* history of blepharitis and meet qualifying criteria for an acute exacerbation of blepharitis in both eyes at Screening and Baseline/Day 1 Visits
* have a qualifying best-corrected visual acuity

Exclusion Criteria:

* abnormality of the eyelids or lashes (other than blepharitis), or previous eyelid surgery
* IOP \> 21 mmHg at Screening or Baseline/Day 1 Visits
* use of steroids in the past 30 days or retinoids in the past 12 months
* uncontrolled systemic disease
A Study of Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir and Raltegravir in Healthy Volunteers

This open-label, multiple dose, single sequence crossover study will evaluate the drug-drug interaction between danoprevir/low-dose ritonavir and raltegravir in healthy volunteers. Subjects will receive raltegravir on Days 1-4 and, after a washout period of 3 days, danoprevir and low-dose ritonavir on Days 8-21, in combination with raltegravir on Days 18-21.


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking male and female adults, 18 - 55 years of age, inclusive
* Healthy status defined by absence of evidence of any active or chronic disease
* Medical history without major, recent, or ongoing pathology
* Weight \>/= 50.0 kg
* Body mass index (BMI) 18.0 - 32-0 kg/m2
* Willingness to abstain from alcohol, xanthine-containing beverages or food (e.g. coffee, tea, cola, chocolate, "energy drinks") from 48 hours prior to entry in the clinical site until discharge
* Females of child-bearing potential and males and their female partners of child-bearing potential must agree to use 2 forms of contraception, one of which must be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom and diaphragm; acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device (IUD) and/or spermicide

Exclusion Criteria:

* Pregnant or lactating females or males with female partners who are pregnant or lactating
* Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections
* Positive test for drugs of abuse at screening or prior to admission to the clinical site during any study period
* Positive for hepatitis B, hepatitis C or HIV infection
* Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
* Use of hormonal contraceptives within 30 days before the first dose of study medication
* History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for Pericapsular Nerve Group Block in Hip Arthroplasty (PENG)

The goal of this clinical trial is to study the analgesic effect of liposomal bupivacaine plus bupivacaine for Pericapsular Nerve Group (PENG) block in postoperative pain management following hip replacement surgery. It will also assess the safety of liposomal bupivacaine for this purpose. The main questions it aims to answer are:

1. Is liposomal bupivacaine plus bupivacaine superior to ropivacaine in terms of analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction?
2. What medical problems do participants encounter when using liposomal bupivacaine plus bupivacaine for PENG block in postoperative pain management following hip replacement surgery?

Researchers will compare liposomal bupivacaine plus bupivacaine to ropivacaine (a routinely used regional anesthetic in clinical practice) to determine if liposomal bupivacaine plus bupivacaine is more effective for pain management following hip replacement surgery.

Participants will:

1. Receive liposomal bupivacaine plus bupivacaine or ropivacaine as a regional anesthetic for PENG block under ultrasound guidance.
2. Undergo hip replacement surgery under spinal anesthesia.
3. Have pain relief, opioid analgesic consumption, and incidence of complications assessed at multiple time points within 72 hours after surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists(ASA) I\~II
* Normal coagulation
* Clinical diagnosis of hip fracture

Exclusion Criteria:

* Presence of severe systemic diseases or ASA grade III or higher
* Allergy to amide local anesthetics
Almond Intervention in Type 2 Diabetes Mellitus

This prospective cohort study of an almond-enriched diet (within the overall context of Asian Indian dietary guidelines) was conducted to test the hypothesis that in patients with T2DM almond-enriched balanced diet improves glycemic measures and CVD risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the age range of 25-65 years
* on stable doses of metformin from past 3 months
* having HbA1C less than 9%
* LDL-c ≥100 mg/dl were recruited

Exclusion Criteria:

* Patients on insulin therapy, plioglitazone, insulin secretagogues, beta blockers or steroids or suffering from diabetes for more than 10 years
* having high uric acid levels (≥ 8 mg/dl),
* with accelerated hypertension (stage 2 hypertension according to JNC guidelines) , hypothyroidism, suffering from acute infection or any debilitating disease or with renal failure,
* appreciable weight loss (more than 10%) during past 6 months
* Patients with known food allergy, lipid altering medication or extraneous factors that can affect glycemic or lipid parameters
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants.

The purpose of this study is to understand if the study drugs of interest are found in breastmilk and how much; to estimate the amount of drug that is consumed by breastfed infants and what effect this may have on infants; and to share what we learn with other researchers. The study drugs of interest have Food and Drug Administration (FDA) approval, but there is little or no information about the amount of drug found in the breastmilk of mothers who take them; the amount of drug that may be transferred to their infant's through breastmilk; or the effects this transfer may have on their infants. During this study we will ask to collect breastmilk and blood from mothers, and blood from infants, to measure the amount of study drug of interest in these body fluids. Results from this study will help researchers better understand how much of the study drug of interest is in your blood and breastmilk, and how much of the study drug of interest may be in your infant's blood because of breastfeeding.

Eligibility Criteria:
Inclusion Criteria:

* Lactating women who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.
* Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines.

Exclusion Criteria:

* Any concomitant condition which, in the opinion of the physicians providing patient care or the principal investigator conducting the study, would preclude a subject's participation in the study.
* Known pregnancy during PK sampling.
tVNS for Depression

This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as primary objective to evaluate changes in depressive symptoms of a transcutaneous Vagus Nerve Stimulation (tVNS) treatment protocol for patients with moderate / severe depressive episode.


Eligibility Criteria:
Inclusion Criteria:

1. patients between 18 and 69 years
2. patients with a diagnosis of depression according to the SCID
3. score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode)
4. agreement to participate in the study as recommended in the IC.

Exclusion Criteria:

1. patients with psychiatric indication for hospitalization
2. patients with psychiatric comorbidity
3. patients with a diagnosis of personality disorder
4. presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.