cyrilzakka/clinical-trials huggingface dataset:
Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep

The cataract surgery (550 000 operations per year in France) is to replace the cloudy lens with a refractive implant. Two colors of implants are available: white implants, filtering out ultraviolet and yellow implants, filtering and more blue light. No clinical data are available to assert the superiority of an implant according to its color and the choice is made according to the preference of the surgeon and / or "markets".

It is established in humans that blue light has an important role on the secretion of melanopsin, a key mediator of the circadian cycle. This "clock" regulates most neuroendocrine functions in the nycthémère (sleep, mood, temperature, cortisol, ..). The question of the impact of these neuro endocrine functions of the installation of a blue light filter into the eyes of patients operated thus arises.


Eligibility Criteria:
Inclusion Criteria:

* female or male subject
* subject between 60 and 90 years old
* Visual acuteness \< or = with 2 eyes
* Indication operating of the cataract

Exclusion Criteria:

* NA
A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018)

The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin for Type 2 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Participant has Type 2 Diabetes Mellitus

Exclusion Criteria:

* Participant has a history of Type 1 Diabetes Mellitus or ketoacidosis
* Participant is on a weight loss program and is not in the maintenance phase or is taking a weight loss medication
* Participant has had surgery within 30 days of starting the study or has planned major surgery
Effects of EPA on Prostate Cancer Cells Proliferation and Quality of Life

Prostate cancer, the most frequently diagnosed cancer among occidental men, is associated with a major individual and societal burden. Although still controversial, the literature suggests that a high consumption of omega-3 fatty acids (ω3) has protective effects against prostate cancer. One of the proposed mechanisms of action of ω3 lies in their anti-inflammatory properties. In addition, there are some observational evidences suggesting an association of ω3 intake with a lower rate of depression in cancer patients. However, no clinical study has tested the efficacy of ω3 supplementation on psychological and quality of life outcomes in that population. Several evidences point to a possible involvement of inflammation in psychological issues. Reducing the systemic inflammatory state may have beneficial impact on the quality of life of these patients. Preliminary work from this team of investigators, in a cohort of patients managed with active surveillance for their low-grade prostate cancer, show a strong inverse association between the risk of prostate cancer progression (to high-grade) and the level of prostatic eicosapentanoic acid (EPA- a type of ω3).

HYPOTHESIS: EPA-rich monoglycerides fish oil (MAG-EPA) has global positive effects on prostate cancer cell proliferation, inflammation and on the patient's psychosocial functioning and quality of life.

The investigators propose a double blind, randomized controlled clinical trial. 130 consecutive patients suffering from high-risk prostate cancer who choose to be treated by radical prostatectomy will be eligible to this study. The presence of high-grade cancer will be mandatory.

The intervention, a daily supplementation with 3g supplement of fish oil monoglycerides rich in EPA, vs. placebo capsules containing high oleic sunflower oil, will start six weeks before the prostatectomy and will continue for one year after surgery. The potential confounding variables will be measured before the start of the intervention: age, anthropometric parameters, stage and clinical and pathological tumor grade (Gleason score), pre-operative level of prostate specific antigen and diet.

This project proposes a simple intervention by dietary supplementation that could eventually help to reduce the incidence and/or progression of prostate cancer, and the consequences of its treatment, and thus could contribute to diminish the heavy individual and societal burden of prostate cancer. The clinical data generated by this trial will serve as solid basis for a large-scale phase III clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer (Gleason score \>= 7)
* Patient has chosen to undergo radical prostatectomy
* Patient agrees to stop taking any omega-3 supplements at least 3 months before the start of the study
* Patient has provided informed consent

Exclusion Criteria:

* Allergy to fish and sunflower
* Suffering from a bipolar disorder
Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis

To assess the efficacy and safety of the Ginkgo biloba extract in patients with Knee OA.


Eligibility Criteria:
Inclusion Criteria:

* patients 40-75 years old with knee OA.
* Grade II and Grade III according to the Kellgrenn-Lawrence (KL) grading system of radiographic OA.

Exclusion Criteria:

* Pregnancy, breastfeeding
* Liver or renal problems
* Patient taking any drug that might interact with Ginkgo extract (eg. warfarin, etc.)
* patient with cardiovascular or cerebral vascular disorders, uncontrolled diabetes, allergic to ginkgo, recent surgery or hospital admission, \>75 years old.
* Allergic or contraindicated to using NSAIDs
Development of a New Diagnosis and Intervention Method for Developmental Disorders

The purpose of this study is to develop a new diagnostic method for developmental disorders based on behavior recording during the interview of the subjects by medical staff as well anonymous persons. The behavior recording by video camera will be accompanied by non-invasive physiological recordings, including electroencephalogram (EEG), electrocardiogram (ECG), electromyogram (EMG), and body temperature using infrared (IR) thermograph. Thus, the physiologically relevant and the disorder correlated behavior parameters could be extracted and used as new diagnostic markers. If necessary, the medical staff may take blood sample from the subject before and after the interview. For the longitudinal study, the similar interview and the recording of the same subject will be planned to evaluate the effect of the medical and educational intervention. The investigators also examine the synergistic effect of the intervention and the administration of the supplement (e.g., vitamin D, arachidonic acid, coenzyme Q10 (CoQ-10)). The clinician may use Risperidone.

Case 1:The investigators started the intervention and supplementation of arachidonic acid for 3 patients diagnosed as autistic spectrum disorders (ASD) from September 4, 2010 at Sawa hospital (Osaka, Japan). Another ASD patients (n=5) at Sawa hospital were treated by administration of Risperidone as medicinal drink from January 14, 2011. The supplementation as well as Risperidone administration followed double-blind placebo controlled cross-over protocol to access the effect of the treatment. These trials will continue until November 2011. Final outcome will be evaluated by clinical diagnosis and behavior parameters measurement as described under Brief Summary.

Case 2: The investigators started the intervention and supplementation of reduced form of CoQ10 for learning disability children (n=20) at small private cramming school (JIZAI-ken, Tokyo) from February 5, 2011. This trial will continue until October 2011. The effect of the intervention and supplementation will be evaluated by behavior parameter measurement as described above.

Eligibility Criteria:
Inclusion Criteria:

* Developmental disorders

Exclusion Criteria:

* Mental retardation
Intraocular Pressure During Robotic Assisted Laparoscopic Procedures Utilizing Steep Trendelenburg Positioning

The purpose of this study is to measure pressures within the eye (during surgery to remove the prostate or abdominopelvic masses) as the body position required for these laparoscopic procedures has been associated with increases in pressure within the eye.

The National Cancer Institute estimates that 218,890 new cases of prostate cancer will have been diagnosed in 2007. The three most commonly chosen options for localized prostate cancer are radical prostatectomy (RP), external radiation therapy (XRT), and interstitial brachytherapy (BT). A variety of surgical approaches are available, including open, laparoscopic, and robotic prostatectomy. With the current trend towards "minimally invasive" techniques, laparoscopic prostatectomy (LP) and, in particular, robotic assisted LP are on the rise. Since gaining FDA approval in 2001, the robotic procedure has gained over 1/3 of the market share. Preliminary data suggests this number may now have grown to over 50% of all prostatectomies for cancer performed in the United States.

The minimally invasive procedures offer some advantages relative to the open alternative: smaller incisions, improved pain control, decreased blood loss, and faster recovery have been well documented. Cancer specific and quality of life (sexual function, continence) outcomes will need more long term evaluation before definitive advantages with the minimally invasive techniques are stated. Furthermore, there are potential risks with these minimally invasive methods that have not been fully elucidated.

During a laparoscopic or robotic prostatectomy, patients are subjected to a marked Trendelenberg position throughout the majority of the procedure. The effect of body positioning has been shown previously to affect intraocular pressure (IOP). However, the effect of surgical positioning on IOP during prostatectomies has not been well studied and is not definitively known. Anecdotal reports of postoperative vision loss following robotic assisted laparoscopic prostatectomy have surfaced thus further research is required to study the effect that these procedures for prostate cancer may have on IOP and vision.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients choosing to undergo surgical treatment for prostate cancer

Exclusion Criteria:

* Prior treatment of prostate cancer by any means
* History of glaucoma, macular degeneration, or diabetic retinopathy
* History of eye trauma/injury
* History of non-refractive eye surgery
* Allergy to topical anesthetic (this will be used during the eye exam)
Investigation of Human Alpha-fetoprotein Genes

Studies revealed that patients with hereditary persistence of AFP also had persistent abnormal AFP. Therefore, this study will recruit the patients and their family with elevated AFP (\>20 ng/mL) and normal AFP patients being control groups. Then, their AFP genes extracted from the blood will be analyzed.

Abnormal AFP elevation was usually noted in liver regeneration, HCC, nonseminomatous germ cell tumors or other malignant tumors. However, some studies revealed that patients with hereditary persistence of AFP also had persistent abnormal AFP. Therefore, we study will recruit the patients and their family with elevated AFP (\>20 ng/mL) and normal AFP patients being control groups. Then, their AFP genes extracted from the blood will be analyzed. The hypothesis of this study is that the mutation of AFP gene might be one of the causes of abnormal AFP.

Eligibility Criteria:
Inclusion Criteria:

* The patients and their family with elevated AFP (\>20 ng/mL) and normal AFP patients being control groups. More than 20 years old

Exclusion Criteria:

* Pregnancy
Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.


Eligibility Criteria:
Eligibility Criteria

- Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)
A Phase 2 Study of ELX-02 in Patients With Nephropathic Cystinosis

This is a Phase 2 open label study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 in patients with cystinosis with nonsense mutation in at least one allele.

Six patients will be enrolled in the trial.

The study will comprise of the following periods for each patient:

* A screening period of up to 6 weeks
* A total treatment period of 4 weeks
* A safety follow-up period of 4 weeks after the last treatment

Each patient will receive three escalating doses as follows:

* Treatment period 1: ELX-02 0.5 mg/kg SC daily for 7 days (total dose not to exceed 3.5 mg/kg for this week; the daily dose will be individualized to achieve the target weekly exposure of about 47.5 µg\*h/mL)
* Treatment period 2: ELX-02 1.0 mg/kg SC daily for 7 days (total dose not to exceed 7.0 mg/kg for this week; the daily dose will be individualized to achieve the target weekly exposure of about 95 µg\*h/mL)
* Treatment period 3: ELX-02 2.0 mg/kg SC daily for 14 days (total dose not to exceed 14 mg/kg for these two weeks; the daily dose will be individualized to achieve the target weekly exposure of about 190 µg\*h/mL)


Eligibility Criteria:
Patients must meet all of the following criteria to participate in this study:

1. Male or female patients who, at the time of screening, are 18 years of age or older (Cohort 1) or ≥12 years of age (Cohort 2)
2. A diagnosis of nephropathic cystinosis and biallelic CTNS mutations, including at least one nonsense mutation
3. Patients should have a mild to moderate disease estimated glomerular filtration rate ≥40 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula
4. Body mass index of 19.0 to 30.0 kg/m2. Patients with a lower BMI may be entered into the study at the discretion of the Investigator following consultation with the Sponsor
5. Renal transplant permitted with stable graft function (serum creatinine) for 3 months prior to Screening

Patients with any of the following characteristics/conditions will not be included in the study:

1. Participation in clinical study including administration of any investigational drug or device in the last 30 days or 5 half-lives (whichever is longer) prior to investigational product dosing in the current study
2. Concomitant use of cysteamine bitartrate from 7 days prior to baseline until 7 days following final administration ELX-02
3. An average systolic blood pressure and/or diastolic blood pressure ≥95th percentile for sex, age, and height on 3 or more occasions during the screening period
4. Patients without documented prior aminoglycoside exposure who have a mitochondrial mutation that has been shown to increase sensitivity to aminoglycosides
5. Known relevant allergy or hypersensitivity to aminoglycosides
Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 1

The purpose is to evaluate implementation of a community-based prevention project aimed at increasing early detection and prevention of breast and cervical cancer through education and navigation and to increase breast and cervical cancer screening and Human Papillomavirus (HPV) vaccination in underserved Latinas.

This is an evaluation of the Salud en Mis Manos community health worker-delivered breast and cervical cancer screening promotion program. The investigators evaluate the effect of the program on increasing participant breast and cervical cancer screening and HPV vaccination, using a one-group pre-post study design (March 2017 - May 2019). The investigators also describe the implementation of the program during a longer time period (November 2016 - May 2019).

Eligibility Criteria:
Inclusion Criteria:

* Self identifies as Hispanic or Latina
* Lives in Texas
* Breast cancer screening group: have not had a mammogram in the past 2 years, and are 40 years of age and older
* Cervical cancer screening group: have not had a Pap test in the past 3 years and are 21 years of age and older
* HPV vaccination group: are women 21-26 years of age, and have not initiated the HPV vaccine series
* Age limit for breast cancer screening group: 40 years and older
* Age limit for cervical cancer screening group (Pap test): 21 years and older
* Age limit for HPV vaccination group: 21-26 years

Exclusion Criteria:

* Current pregnancy
* Current or prior cancer diagnosis
Chair-bound Exergaming in Pre-frail/ Frail Older Adults in Nursing Home

This pilot randomized controlled trial is designed to investigate the effectiveness of chair-bound exergaming on improving physical and cognitive function in pre-frail/ frail nursing home residents

Objective To evaluate the effects of the chair-bound exergaming in improving physical and cognitive function in pre-frail/ frail nursing home residents.

Research plan and methodology Thirty nursing home residents will be recruited from the nursing homes.

All the eligible participant will be randomly allocated to either one of the following 2 groups (i) Exergaming (intervention group), or (ii) wait list control.

1. Intervention group (exergaming group, ERG) Those allocated to the ERG will receive supervised chair-bound exercise programme for 12 weeks.
2. Control group (wait list control, CG) Those allocated to the CG will receive supervised chair-bound exercise programme for 12 weeks after post-assessment.

Eligibility Criteria:
Inclusion Criteria:

* older adults aged 60 years or older living in the nursing homes;
* pre-frail or frail according to the Fried Frailty Phenotypes;
* ability to understand and execute instructions; and
* ability to sit unassisted on a chair or in a wheelchair.

Exclusion Criteria:

* no controlled medical diagnosed of severe cardiometabolic, respiratory and musculoskeletal disorders;
* any conditions that hinder the participation of intervention and assessment; and
* being involved in any other clinical trials.
A Study of SDI-118 in Participants in Remission From Depression

This is a multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on male and female study participants reporting with cogntive decline and who in remission from depression.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants between 25 and 55 years of age (inclusive) at screening.
* Are remitted from depression.
* Have received prescribed treatment with an antidepressant or a recognised psychotherapy for depression (e.g. cognitive behaviour therapy) for a previous MDE
* Report present subjective cognitive impairment (such as difficulty concentrating, slow thinking, and difficulty in learning new things or remembering things).
* Have not been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to Screening Visit 1.
* Otherwise healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, haematologic assessments, and urinalysis, measurement of vital signs, and Electrocardiogram (ECG).
* Negative serology test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at screening.
* Have a body mass index (BMI) of 18 to 36 inclusive.
* Agree not to use herbal medications (including herbal tea, St. John's Wort), within 14 days prior to study agent administration through to the final follow-up visit.
* Participants must be able and willing to give written, informed consent, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
* The participant, in the opinion of the investigator, is willing and able to adhere to the study visit schedule and other requirements, prohibitions and restrictions of the study.

Exclusion Criteria:

* They are left-handed.
* Have immediate recall of greater than 22 words from the International Shopping List Test (ISLT) and have delayed recall of greater than 8 words from the ISLT 15 mins after the presentation of the word list.
* Positive urine drug screen or alcohol breath test at screening or assessment visits.
* History or presence of significant neurological or psychiatric conditions except those related to MDD.
* Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 3 months prior to screening or at screening or baseline visit.
* Has a known clinically relevant structural brain abnormality as determined by e.g. previous MRI, or, persistent MRI imaging artefact which is judged to produce extensive imaging distortions.
* Has a disease or takes medication that could, in the investigator's and/or sponsor's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
Mastocytosis Registry (of Zurich)

The study aims to summarize patients with mastocytosis and hypertryptasämia (without underlying mastocytosis or no bone marrow biopsy) in relation to demographic information, clinical progress and treatment courses. Biologic samples are collected from available routine diagnostics (serum, skin tissue, gut mucosa, bone marrow, and others) for further use in experimental research.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with mastocytsis/hypertryptasemia which are treated at the university hospital of Zurich
* available informed consent

Exclusion Criteria:

* denied consent
A Comparison of the Ambu®AuraGain™ and the Laryngeal Mask Airway Supreme™ in Normal Airway Patients

The study is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway and LMA Supreme in normal airway patients.

Ambu AuraGain Laryngeal Mask Airway is a newly designed supraglottic device. We design this study to test its clinical performance in normal airway patients, in comparison with LMA Supreme.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Ⅰ-Ⅲ classification
* Patients evaluated as eligible for a LMA
* Body Mass Index ≤35kg/m2

Exclusion Criteria:

* Patients with known or predicted difficult airway
* Active respiratory infection
* Risk of aspiration
* Head and neck surgery
* Emergent surgery