cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effects of Saffron Extract on Sleep Quality and Stress

Therefore, the aim of this study was to confirm by a randomized double-blind controlled study the beneficial effects of saffron extract (Saffr'activ®) on sleep quality in subjects presenting mild to moderate sleep disorder associated with anxiety.

This study has been designed as a randomized double-blind placebo-controlled interventional study.

Sixty-six subjects were randomly allocated to the control (placebo) or test (Saffr'activ®) group.

A screening visit was scheduled within 4 weeks before Day -7 (study inclusion). At Day -7 and Day 0, questionnaires were completed to evaluate sleep quality, stress level and quality of life. Between Day -7 and Day 0 baseline data for actimeter and sleep diary were registered. Then, subjects were supplemented during 6 weeks with the placebo or saffron (Saffr'activ®) product, depending on their group. Following the baseline period, two other periods of one week were scheduled to collect actigraphy data: between 2 and 3 (from Day 14 to Day 21) weeks and between 5 and 6 (from Day 35 to Day 42) weeks after the beginning of the intervention. At the middle (Day 21) and at the end of the study (Day 42), questionnaires were completed to evaluate sleep quality, stress level and/or quality of life.

Eligibility Criteria:
Inclusion Criteria:

* In good general health as evidenced by medical history and physical examination;
* Presenting mild to moderate chronic primary sleep disorder (evaluated by Insomnia Severity Index - ISI, score between 7 and 21);
* Presenting mild to moderate anxiety (evaluated by Perceived Stress Scale - PSS, score between 6 and 29);
* For women: use of effective contraception;
* Fluent French speaking;
* Provision of signed and dated informed consent form;
* Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

* Sleep disorders secondary to another health problem;
* Lifestyle habits which would modify the wake-sleep rhythm (e.g. night work) or which would be modified during the study period;
* Pharmacological resistance to common hypnotic drugs or consumption of hypnotic drugs (\< 3 months before the inclusion);
* Subjects presenting gastro-intestinal, hepatic, respiratory, psychiatric, kidney or cardiovascular disorders (\< 3 months before the inclusion);
* Abnormal blood sampling;
* Subjects presenting depressive disorder (BDI score \> 30);
* Recent (\< 3 months before the inclusion) change in lifestyle (food, body weight \> 5kg, sport);
* Within 3 months before the inclusion, chronic (\> 7 days in a row) intake or dosage change of drug(s) or food supplement(s);
* Addict subjects or with historical addiction;
* Subjects who drink more than 3 glasses of alcohol per day (\> 30g of alcohol per day);
* Exaggerated consumption of theine (≥ 500ml per day) and caffeine-rich (≥ 400ml per day) beverages and energy drink (≥ 250ml per day);
* Pregnant or lactating woman;
* Known allergy to saffron and/or olives;
* Subjects having participated to another clinical trial one month before the selection visit.
A Study of the Effectiveness of an Early Intervention on Adolescent Hazardous Gaming

The investigators established a mobile-based early intervention on adolescent hazardous gaming and verified its effectiveness.

Hazardous gaming is the precursor of gaming disorder. Early intervention on hazardous gaming is an effective strategy to prevent gaming disorder. Currently, there are few evidence-based early interventions, particularly the technology-based approaches with the advantage of user-friendliness. This study developed a mobile-based early intervention program based on cognitive-behavioral therapy (CBT) for adolescent hazardous gaming. In order to verify the effectiveness of the intervention, adolescent participants were recruited and divided into two groups. The intervention group received the one-month intervention, while the control group did not. Both groups accepted the assessments at baseline and two months after the intervention. Comparative analysis was carried out between the two groups and two time points, primarily on the severity of gaming disorder, gaming hours, gaming frequency, anxiety, depression and self-esteem.

Eligibility Criteria:
Inclusion Criteria:

* (1) Clinical diagnosis of hazardous gaming defined in the ICD-11 (2) Fully comprehending the research's purpose and procedures and signing the informed consent

Exclusion Criteria:

* (1)Serious physical illness or intellectual disability (2) Clinical diagnosis of gaming disorder (3) Not completing all the interventions or assessments
Neobladder Posterior Wall Suspended With Round Ligament of Uterus

Objective: to evaluate if the Neobladder posterior wall suspended with round ligament of uterus could improve neobladder empty after radical cystectomy in female patients with bladder cancer compared to present standard neobladder

The investigators developed a technical modification which to aim to provide an posterior support to the ideal neobladder and obtain the anatomy recovered neobladder by posterior wall of neobladder suspended with round ligament. In this study the investigators designed the prospective random trial to evaluate whether this technique improves the neobladder empty compared to a current standard neobladder reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for the study were bladder cancer (Stage T1G3, T2-3N0-NxM0), female (age between 40 and 70 years old), no history of urethral trauma or urethral stricture; and a desire to obtain an orthotopic neobladder

Exclusion Criteria:

* The exclusion criteria were male sex, posterior urethral margin confirmed as cancer invasive by pathology; and enteritis. The indications and contraindications for orthotopic reconstruction in this study conformed to the criteria set by the guidelines of the European Association of Urology on bladder cancer
Effect of Repeated Botulinum Toxin Injection on Gait Pattern in Stroke Patients

Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved kinematic gait parameters(GP) but surprisingly none of them assessed the effects of repetitive multifocal BTI on patient's gait pattern and their duration.

The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic stroke patients. To that end, gait of patients will be compared using 3D-gait analysis after 3 consecutives BTI sessions.

All the patients will be treated with BTI . These injections will be performed under electrical stimulation control (\~5mA). The dose, the number of site of injection per muscle is at the discretion of the physician according to patients' needs and physicians' routine clinical practice. The dilution the most commonly used will be 100 U for 2.5ml (XEOMIN®)

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* a single hemispheric cerebral vascular lesion more than 6 months previously
* able to walk 10 meters without any assistance
* having benefited of at least 2 consecutive BTI sessions, second 3D gait analysis performed at least 3 months after the last BTI.

Exclusion Criteria:

* patient's refusal to participate to the study
* Inability to read the selected text
* Inability to cooperate
* No affiliation to social security
Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide

Primary Trial objectives:

To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on verum per dose level, 10 subjects receiving placebo)

Secondary objectives:

To evaluate safety and tolerability by using adverse events (AEs) and vital signs

Primary Trial objective:

To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in healthy, male volunteers after single intravenous administration

Secondary objectives:

To evaluate safety and tolerability by using adverse events (AEs), vital signs including blood pressure/pulse rate (BP/PR), electrocardiographic examinations (12 lead ECG), evaluation of antibody titer and safety laboratory tests (biochemistry, hematology, coagulation, urinalysis)

Methodology:

Mono-center, single-blind, dose escalating study with five dose levels (8 subjects on verum per dose level, 2 subjects receiving placebo) in a total of 50 volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, male Caucasians between 18 and 45 years of age, inclusive
* Normotensive subjects (systolic BP \<140 mmHg and diastolic BP \<90 mmHg)
* Body mass index (BMI) 19-27, minimal weight 60 kg
* Negative results in HIV antibody, HBs antigen (HBsAg) and HCV tests, and negative result in anti-ß1-receptor-autoantibody screening
* Signed Informed Consent Form
* Normal or clinically irrelevant laboratory findings

Exclusion Criteria:

* Autoimmune disorders
* Kidney diseases
* Liver diseases, liver function impairments
PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study

The purpose of this single institution, pilot study is to explore the out of pocket (OOP)costs and financial toxicity of cancer care for patients during definitive treatment of head and neck cancer with radiation therapy with or without chemotherapy and surgical resection. The study team will assess how the financial burden of cancer care impacts quality of life as well as treatment-related decision-making from a patient perspective.

This is a prospective, single institution, survey-based study to assess OOP costs, financial toxicity and pateint reported outcomes (PROs') (including QOL, quality of care, and attitudes/perspectives on the role of cost in treatment decisions). Potential participants are new patient consults in Radiation Oncology Head and Neck Cancer Clinic. Patients with an indication for definitive treatment involving radiation therapy will be approached by study staff and, if amenable, enrolled in the study. After signing informed consent, they will complete a baseline survey assessing socioeconomic household information, baseline symptoms/QOL and baseline costs/financial toxicity. They will be followed prospectively and re-surveyed at 3 and 6 months after completion of radiation therapy. Repeat assessments will document treatment costs and PRO including QOL, financial toxicity, and self-reported quality of care. Patients will be asked to collect all treatment-related bills in a provided binder, which will be reviewed at each survey date. Basic demographic data (including age, sex, race, marital status, zip code, and insurance coverage), comorbidities, smoking status, cancer characteristics (stage, site, histology), treatments received, emergency department visits and hospitalization rates at baseline, end of treatment, 3 months and 6 months after radiation treatment will be collected as part of this study. Disease status and survival will also be assessed from standard of care follow-up visits up to five years after completion of radiation treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (18 years or older) patients
2. Diagnosed with HNC with treatment plan including definitive radiation therapy or chemotherapy/radiation therapy
3. Be able to read and write in English
4. Able to give informed consent and complete survey materials

Exclusion Criteria:

1. Recurrent disease
2. Metastatic disease
3. Prior radiation courses must be approved by PI prior to approaching patient for enrollment (prior systemic therapy is not an exclusion to study enrollment).
Clinical Evaluation of Daptomycin Bone Penetration

Bone and joint infections are commonly due to Gram-positive bacteria. Treatment of these infections is difficult because of the need of prolonged duration of antimicrobial agents in combination with surgical procedure. Moreover, in recent years, a growing resistance pattern to various antimicrobial agents has been observed for Gram-positive bacteria. Consequently, there is an urgent need for new drugs with high bone penetration for the treatment of those infections. The investigators hypothesized that daptomycin allow to achieve high concentrations in bone compartments.


Eligibility Criteria:
Inclusion criteria:

* Patient under treatment with daptomycin for more than 3 days with dosage at 6 mg/kg
* Patient undergoing imperative surgery with bone withdrawal
* Signed, and dated informed consent as defined by the Institutional Review Board
* Male and female patients older than 18 years of age
* Patients with social insurance
* Patient with information on previous mandatory medical examination

Exclusion criteria :

* Patient with no treatment by daptomycin or with a dosage \< 6mg/kg or with less than 3 doses of daptomycine
* Patient with no need for surgery
* Patient younger than 18 years of age
* Pregnant and nursing women
* Patient refusal for inclusion
* Patients with deprived liberty
* Inability to complete the informed consent process because of problems with mental capacity
A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions

The Dermacorder measures the electric field in the skin. Malignant skin lesions disrupt the skin's normal electric field and this abnormal electric field can be detected by the Dermacorder. Therefore the investigators are testing the hypothesis that the Dermacorder can provide useful data to guide in the diagnosis of skin disease.

The Dermacorder is a non-invasive medical device that scans a probe over the skin about 200 microns away from it and detects the electric field in the skin using capacitative coupling. Measurements of hundreds of malignant melanomas in mice indicated that these lesions generate an electric field that is easily detected. One previous clinical trial at the VA Medical Center in Hampton VA indicated an 80% reliability in predicting malignant lesions by their electric field. We have improved the Dermacorder over the past two years by enhancing its sensitivity and stability and must now determine if these improvements have improved its ability to detect malignant lesions. If the Dermacorder provides a reliable diagnosis of malignant lesions, its use could dramatically reduce the number of biopsies performed and this would significantly improve the quality of life for hundreds of thousands of Americans seeking the advice of dermatologists regarding suspicious lesions each year

Eligibility Criteria:
Inclusion Criteria:

* Study subjects must have had diagnosed at least one benign or malignant skin lesion;
* Subject is from 18-75 years of age, inclusive;
* Subject must sign and date all informed consent statements.

Exclusion Criteria:

* Subject is exhibiting signs of a bacterial or viral infection, including fever;
* Subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.
Procalcitonin Level and the High Risk of Mortality in 30 Days in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patient , Cases Series.

Background:

Procalcitonin (PCT) is a biomarker that has been proposed as a helpful tool in inflammatory Clinique cases specially patient with pulmonary bacterienne infection .

Materials and methods the investigatore had retrospectively reviewed the electronic records and lists of all 582 COVID-19 patients admitted on the ICU of Hospital university Mohammed VI , Oujda. Between 01 juin 2020 and 31juanary 2021 , and analyzed the relation of PCT value and mortality at 30 days until we can defined a cut off Procalcitonine to use as a marker of severity and high mortality .

Our objective is to assess the relationship between Procalcitonin and 30-day mortality in patients admitted to the resuscitation department of the Mohammed VI University Hospital Center, Oujda, Morocco, infected by the SARS COV 2 Virus .

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of SARS COV2 infection needed admission in ICU .

Exclusion Criteria:

* patient under 15 ans
CARBON: UAB Cardiovascular Research Biobank

The UAB Cardiovascular Research Biobank (CARBON) will be a resource that contains biological materials, such as DNA samples, in addition to health and personal information on a large number of people over time. It will be set up so that it can be used in the future as a resource for researchers undertaking a wide range of medical research.

The UAB Cardiovascular Research Biobank (CARBON) will be a resource that contains pertinent genetic, health, and biological samples such as blood derived from a large-scale population. Researchers may use disease correlates and predictors identified from the genetic, health, and personal information contained in the Biobank as a resource to investigate cardiovascular disease, hypertension, diabetes, and a myriad of other disorders. Through these studies, researchers may identify the progression of risk factors in certain diseases and help develop novel strategies to detect, treat, or prevent such diseases. In addition, the Biobank serves as a valuable tool to assess how certain treatments may respond differently to individuals as a result of genotypic differences.

The investigators have demonstrated that lower natriuretic peptide (NP) levels are associated with a decreased insulin sensitivity and have a causal role in the development of diabetes and have also shown that certain populations, such as African Americans, have relatively low NP levels, which may contribute to their underlying risk for insulin resistance. Since NPs play an important role in the regulation of insulin sensitivity, one can infer that relatively low NP levels are an important biological contributor to the high prevalence rates of cardiometabolic disease in African Americans. The Biobank will contain genetic information concerning the presence of gene variants that encode NPs.

Eligibility Criteria:
Inclusion Criteria:

* Age more than or equal to 18

Exclusion Criteria:

* Age \<18, at screening
* Employees or students associated with the Division of Cardiovascular Disease at UAB will not be recruited due to their vulnerable status and susceptibility to coercion.
* Women who are pregnant or who can become pregnant and not practicing an acceptable method of birth control.
Acetaminophen vs Placebo in the Pre-operative Setting and Outcomes on Post-operative Pain, Nausea and Vomiting

The purpose of this study is to determine whether a single dose of IV acetaminophen can improve post-operative pain, nausea, and vomiting in the outpatient setting. Patient satisfaction, time to readiness of discharge, and the amount of opiates post operatively will also be measured.

The purpose of this study is to determine if using a one time pre-operative dose of IV acetaminophen has an effect on post-operative nausea, vomiting, and pain. This is a randomized, double-blind, placebo-controlled prospective study on patients from the Katzmann Breast Center undergoing outpatient breast surgery (including excisional biopsy, lumpectomy, sentinel lymph node biopsy, axillary node dissection, or ductal excision).

IV acetaminophen (paracetamol) has been in Europe and other countries. In the U.S. the FDA approved IV acetaminophen (Ofirmev) in November of 2010. Since then, it has been used in many different ways, but most commonly in the first 24 hours post operative recovery period.

There will be two arms included in this study. Patients in Arm One will receive a one gram dose of IV acetaminophen in the pre-operative area. Patients in Arm Two will receive a dose of the placebo (IV normal saline). The medication will be disguised in the same bag as the normal saline, so no one (including the patient) in the pre-operative area will know which arm the patient is in. This prospective, randomized, double blind study will compare post-operative nausea, vomiting, and pain rates in patients from both arms.

The primary endpoint of this study will be to compare post-operative pain in patients receiving a pre-operative dose of IV acetaminophen to patients receiving the normal saline placebo. Secondary endpoints will include post-operative nausea and vomiting, recovery times, and overall satisfaction of pain management throughout their experience (assessed on post operative day one). If this study shows that IV acetaminophen given in the pre-operative setting decreases post-operative nausea, vomiting, and/or pain and/or shortens recovery time, and improves patient satisfaction in regards to their pain management, it could also become a routine medication given to all patients in the pre-operative setting.

Eligibility Criteria:
Inclusion Criteria:

Each of the following must be met:

* Greater than or equal to 18 years of age.
* Female
* Undergoing outpatient breast surgery (unilateral or bilateral surgery)

Exclusion Criteria:

If ANY of the following apply:

* History of an allergy or hypersensitivity to acetaminophen (oral, rectal, or IV)
* Chronic alcoholism
* Severe deficiency of liver and/or kidney
* Any patient unable to sign informed consent
* Pregnancy
* Any patient currently enrolled in another experimental protocol
Safety and Efficacy Study of NGGT001 in Bietti Crystalline Corneoretinal Dystrophy

Evaluate the safety and tolerability of NGGT001 subretinal injection for the treatment of crystalline retinal degeneration (BCD)


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old;
2. Gender unlimited.
3. Diagnosed as crystalline retinal degeneration (BCD).
4. Molecular diagnosis confirms CYP4V2 mutation.
5. The best corrected visual acuity is less than 20/60.
6. Agree to take contraceptive measures within 1 year from the start of the study until administration.
7. Voluntarily sign an informed consent form.

Exclusion Criteria:

1. Insufficient number of photoreceptor cells in the retina, such as retinal thickness less than 100 μ m. Or no atrophy or pigmentation in the posterior pole area\&amp;amp;lt;3- Retinal disc.
2. The presence of choroidal neovascularization or other eye lesions caused by BCD, which researchers believe may affect surgical procedures or interfere with the interpretation of clinical endpoints.
3. The use of therapeutic drugs within the first 6 months of enrollment may affect experimental observation, such as Lucentis, Avastin, Conbercept, Triamcinolone acetonide, steroids, etc;
4. The treatment eye has undergone intraocular surgery, such as PDT, vitrectomy, periocular vascular bypass surgery, etc., or requires intraocular surgery during clinical research, such as cataract surgery, retinal laser therapy, etc;
5. Used or may use systemic medications that may cause eye damage, such as psoralen, tamoxifen, etc;
6. Highly sensitive or allergic to the ingredients in the experimental drug (with a history of allergies to two or more drugs or foods);
7. Abnormal and clinically significant physical examination, vital signs, laboratory tests (such as blood routine, urine routine, blood biochemistry, coagulation function, immunological tests, etc.), or abnormal indicators deemed clinically significant by researchers;
8. There are diseases or medical histories that may affect drug safety or internal processes, especially cardiovascular, liver, kidney, endocrine, digestive, lung, neurological, hematological, tumor, immune or metabolic disorders that researchers consider clinically significant.
9. Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment;
10. Female patients during pregnancy or lactation;
11. Other researchers believe that it is not suitable to participate in the study.