cyrilzakka/clinical-trials huggingface dataset:
St.Jude Medical Cardiac Lead Assessment Study

The Cardiac Lead Assessment Study (CLAS) is designed as a prospective, non-randomized, multi-center, international postmarket surveillance study under 522 Order PS120111 (August 16, 2012).

The objective of this study was to determine the prevalence and incidence of externalized conductors and other visual lead anomalies (as evidenced by imaging) and the risk of progression to electrical dysfunction in subjects with one or more of the following St. Jude Medical (SJM) cardiac leads: Riata leads, Riata ST leads, Durata and/or QuickSite/QuickFlex Cardiac Resynchronization Therapy (CRT) leads.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has a market released SJM Implantable Cardioverter Defibrillator (ICD), CRT-D or CRT-P already implanted.
2. Patient has at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted in which the lead model number and lead implant date is indicated in Table 1 (see protocol attached.)
3. Have the ability to provide informed consent for study participation and be willing to comply with the prescribed evaluations as detailed in this study plan.
4. Are 18 years or above

Exclusion Criteria:

1. Patient is currently pregnant.
2. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study
Clinical Study of Genakumab for Injection in Chinese Healthy Volunteers

To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in Chinese healthy adult volunteers

There are 5 dose groups with 8 participants in each group, including 6 participants in the experimental group and 2 participants in the placebo control group.

Since the strength of experimental drug is 150mg/1ml/ bottle, participants with a single dose of more than 150mg need to be given subcutaneously at different sites in two or more times

Eligibility Criteria:
Inclusion Criteria:

* 18 years ≤ age ≤50 years, and in good health;
* 40kg ≤ weight ≤100kg , and body mass index is within the range of 18 - 28 kg/m\^2 (including 18 kg/m\^2 and 28 kg/m\^2);
* No parental scheme from the screening period to 6 months after the study period.

Exclusion Criteria:

* Participants have abnormal physical and auxiliary examination results with clinical significance;
* History of cardiovascular, liver, kidney, digestive, blood, nervous system and allergic diseases, mental and metabolic disorders, acute or chronic bronchospastic disease;
* Smoking more than 5 cigarettes per day;
* Participants who use any prescription drugs within 4 weeks prior dosing, or over-the-counter medication within 2 weeks prior to dosing. Participants who receive treatment of any biologics within three months prior to dosing. Participants who receive (attenuated) live vaccines within six months prior to dosing;
* Participation in any clinical investigation within 3 months prior to dosing;
* Donation or loss of 400 mL or more of blood within 3 months prior to dosing; donation or loss of 200 mL or more of blood within 4 weeks prior to dosing; or donation of component blood within 2 weeks prior to dosing;
* Tuberculosis symptoms, contact with patients with suspected tuberculosis symptoms
* Positive results in Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, Syphilis antibody or HIV antibody;
* Clinically significant acute infection within 2 weeks prior to dosing;
* Current or previous drug or alcohol abuse;
* Other conditions in which the investigator preclude enrollment into the study.
Interest of the SPECT-CT Scan SUVspect in the New Generation of Gamma-cameras With Semiconductor

Since 2017, a revolution began in the departments of nuclear medicine, with the routine use of gamma-cameras with semiconductor. These gamma-cameras (which obtained the CE-marking in 2016), offer a technological breakthrough by providing an additional information. They allow "to quantify" for the 1st time in clinical routine conditions, the quantity of radioactivity, by means of a "SUVspect", in a volume of interest, while respecting the recommendations of best practice of the learned societies of French nuclear medicine (SFMN), European (EANM) and American (SNM), without injection of tracer nor acquisition or additional irradiation. The SUVspect is therefore an indicator of the quantity of tracer in a given volume of acquisition.

Until now, the interpretation criteria of scintigraphies are based on the homogeneity of distribution of a tracer in the explored organ (for single organs such as the heart or the thyroid, for example) or in the asymmetry of distribution of the tracer (for the double organs, such as the kidney or the joints).

This new gamma-camera allows to study the distribution of the radio-tracers in "list" mode, allowing to retrospectively reconstruct the images in various ways (for example, by modifying the size of the matrix of acquisition, the energy windows, the time of acquisition). Therefore, we can simulate and propose modifications in current procedures.

Every patient referred to our department of nuclear medicine to undergo a scintigraphy with a tracer of nuclear medicine (with a marketing authorization) can, while benefiting from an examination by this gamma-camera, to be the object of this study, and to profit from this additional information.

So, without changing the diagnosis or the usual care, we wish to take advantage of this additional information to improve the criteria of interpretation of our examinations.

This possibility being new, there is no available bibliography (our department is the 5th department of nuclear medicine in Europe to equip itself with this large field-of-view gamma-camera CZT, the DNM 670, made by General Electric), while 2961 articles speak about the SUVmax (in PET) in Pubmed.


Eligibility Criteria:
Inclusion Criteria:

- informed adult patients referred to our department of nuclear medicine for a nuclear medicine exploration

Exclusion Criteria:

* Refusal to participate
* Patient under guardianship
Surgical Sample Collection- Sampling During Uterine Surgery

The goal of this clinical trial is to evaluate anatomical locations for sample collection for future decisions for diagnostic test development.


Eligibility Criteria:
Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent form (ICF) indicating that the participant has been informed of all pertinent aspects of the study.
2. Willing and able to comply with scheduled visits, investigational plan, and other procedures.
3. Females:

   1. Aged \>45 for benign and pre-malignant cases
   2. Aged \>18 with positive biopsies.
4. Presence of uterus.
5. Scheduled for hysterectomy.

Exclusion Criteria:

1. Investigator site staff members directly involved in the conduct of the study and their family members or participants who are Pink Dx, Inc. employees or their family members.
2. Other acute or chronic medical or psychiatric conditions that would increase the risk associated with study participation in the judgement of the investigator.
3. Women who have undergone a hysterectomy.
4. Inability or unwillingness to sign informed consent.
5. Contraindication to surgery, including pregnancy.
6. Women who have used a tampon within 7 days of surgery.
Phase 2b/3 Trial of NuSepin® in COVID-19 Pneumonia Patients

A Randomized, Double-blinded, Placebo-controlled, Parallel-treatment Group, Adaptive Design, Multi-center, Phase 2b/3 Trial to Evaluate Efficacy and Safety of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients


Eligibility Criteria:
Inclusion Criteria:

1. An individual who or whose legally authorized representative has fully informed of all pertinent aspect of the trial and IMP, voluntarily decided to participate in the trial and adherence to the trial-related requirements, and provided a written informed consent
2. An adult man or woman aged between 19 years (or age of majority in his/her country) and 80 years.
3. A hospitalized patient with laboratory-confirmed SARS-CoV-2 infection by PCR test within 10 days (240 hours) prior to randomization.
4. At the time of randomization; whose clinical status is stage 4 (oxygenation by facial mask or nasal cannula) or 5 (non-invasive ventilation or high flow oxygen) on WHO 8-point ordinal scale
5. Pneumonia that satisfies all the following criteria at the time of randomization
6. Planned first dosing of the IMP not later than 2 days after the initiation of standard of care (SOC), when given in combination with SOC for severe Illness (according to NIH Clinical Spectrum of SARS-CoV-2 Infection)
7. A score of 5 points or more ("think sepsis") on the NEWS 2 scale at the time of randomization

Exclusion Criteria:

1. A patient whose clinical status is stage 3 or lower on the WHO 8-point ordinal scale (WHO 8-OS) at the time of randomization
2. An individual who requires endotracheal intubation, mechanical ventilation (WHO 8-OS stage 6), or extracorporeal membrane oxygen therapy (stage 7) at the time of randomization
3. A patient with multiorgan failure, shock, acute respiratory syndrome (ARDS)
4. A patient with renal dysfunction defined by eGFR less than 30mL/min/1.73m², or the use of hemodialysis or hemofiltration
5. Cholestatic liver disease (example: biliary obstruction, cholangitis, etc.) or hepatic dysfunction
6. Any of the following laboratory test results at the time of screening:
7. An individual with HIV-positive results or who requires antiviral treatments against active hepatitis (HBV, HCV) and etc.
Intelligent-C Endoscopy Module for Real-time Detection of Colonic Lesions

To conduct an single blinded, non-randomized, prospective, single center trial to validate the performance of a novel state-of-the-art Artificial Intelligence model (AI-Model) for colorectal lesion detection during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Consecutive patients referred for a screening, surveillance or diagnostic colonoscopy will be included

All procedures will be performed with high-definition endoscopes; Bowel preparation will be conducted according to usual local practices. During colonoscopy, the colonoscope will be first advanced to the cecum in all patients as confirmed by identification of the appendicular orifice and ileocecal valve or by intubation of the ileum, as per the standard of care by experienced endoscopists. During the insertion, no action will be taken. After cecal intubation is performed, the colonoscope will be slowly withdrawn to the splenic flexure by the primary endoscopists. Real time AI detection model will be activated with the output displayed in real time on a separate monitor and will be only viewed by an independent investigator, who is an experienced endoscopists (or a person trained in polyp recognition). The primary endoscopists will be blinded to the AI real time detection result

All detected polyps will be removed or with biopsy taken during this examination and sent for histopathology examination.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing colonoscopy of age 18 to 80 years.
2. Patient who has read the informed consent form, has understood the relevant aspects of the study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the study and the performance of any procedure
3. Consecutive adult patients scheduled to undergo routine colonoscopy at AIG

Exclusion Criteria:

1. Females who are pregnant
2. Patients who are unsuitable for any other reason to participate in the study in the opinion of the investigator
3. Recent colonoscopy within past 12 month
4. History of inflammatory bowel disease
5. History of colorectal cancer
6. Previous bowel resection (apart from appendectomy)
7. Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
8. Bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe.
Lutein Bioavailability From Fresh and Dried Beverages

Macular pigment is composed primarily of the xanthophylls lutein and zeaxanthin, which are members of the carotenoid family. Epidemiological evidence indicates that a higher intake of lutein and zeaxanthin is associated with a lower risk to develop age-related macular degeneration (AMD). The lipid matrix of an egg yolk is an excellent vehicle for the efficient absorption of dietary lutein and it is possible to increase the natural lutein concentration in an egg yolk. A fresh lutein-enriched egg yolk beverage has been produced using these lutein-enriched egg-yolks. However, this beverage has a limited shelf life of maximum three weeks. Drying this fresh beverage extents the shelf live, however, this should be without loosing its functional properties concerning lutein bioavailability. At WUR-FBR two types of drying procedures have been evaluated resulting in two different dried product formulations, which need to be tested. The question is, whether the lutein bioavailability is not affected by different drying procedures.


Eligibility Criteria:
Inclusion Criteria:

* age 18-35 years
* BMI 18-25 kg/m2
* body weight should be stable for ≥6 months (with no weight gain/loss \> 3 kg)

Exclusion Criteria:

* use of medication except incidental use of pain killers
* pulmonary inhalation medication and except usage of the contraceptive pill
* chronic diseases such as IBD or other stomach or bowel diseases
* not willing to discontinue consumption of vitamin supplements
* allergic to cow milk / dairy products/ eggs/ egg-rich products
* vegetarians
* smoking
* pregnant or breastfeeding women
* having donated blood (as blood donor) within 1 month prior to the screening
* visit or planning to do so during the study
* impossible or difficult venapuncture
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 10773 in Healthy Male Subjects

Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses of BI 10773 to healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males according to the following criteria:

   Based upon a complete medical history, including the physical examination, vital signs ((blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
2. Age ≥ 18 and Age ≤ 50 years
3. BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

1. Any finding of the medical examination including ((blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (ECG)) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
6. History of relevant orthostatic hypotension, fainting spells or blackouts.
7. Chronic or relevant acute infections
8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
9. Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
10. Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
11. Participation in another trial with an investigational drug within two months prior to administration or during the trial
12. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
13. Inability to refrain from smoking on trial days
14. Alcohol abuse (more than 60 g/day)
15. Drug abuse
16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
17. Excessive physical activities (within one week prior to administration or during the trial)
18. Any laboratory value outside the reference range that is of clinical relevance
19. Inability to comply with the dietary regimen of trial site
20. A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval \>450 ms);
21. A history of additional risk factors for torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome);

    Exclusion criteria specific for this study:
22. Elevated urinary glucose levels at screening (\> 15 mg/dl; \> 0.83 mmol/L)
Study in Healthy Volunteers to Document Safety and Tolerability of Increasing Doses Pemirolast

This study is a single-centre, open-label, dose escalation , safety, tolerability and pharmacokinetics (PK) study in healthy male and female subjects. The study include a screening day and a 5-day dosing period. Subjects will be enrolled in sequential cohorts and each cohort will include 8 subjects. there will be 24 subjects total included in the study. The duration of the clinical part of the study will be approximately 2 months.

Subjects meeting the eligibility criteria at screening will remain in the clinic from the evening preceding the first day of dosing (Day - 1) of the investigational medical product (IMP) and check out from the clinic 24 hours after the first dose administration of the IMP (in the morning of Day 2). Dose administration of the IMP in the evening of Day 2 and morning and evening dose for Days 3 and 4 will be performed at home. The subjects will check-in again in the morning of Day 5 and receive the last dose administration of the IMP and stay in the clinic 12 hours post dose. All subjects within the same cohort will receive the same dose of the IMP.

There will be 3 cohorts (dose-levels) with 8 subjects in each cohort corresponding to 24 subjects in total. Within a cohort the subjects will be dosed in groups of 4. There will be 24 hours between the dosing of the groups and 15 minutes between the dosing of the subjects in a group.

There will be an interval of approximately at least 1-week interval between the cohorts to allow time for compilation and evaluation of data for the Internal Safety Review Committee meeting.

Subsequent cohorts will be administered increasing doses until either the maximum tolerated dose (MTD) or the study maximum dose (SMD) has been reached.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent, healthy subjects aged 19-65 years

Exclusion Criteria:

* Significant concurrent disease or medical conditions that are deemed to interfere with the safety or pharmacokinetics of CRD007 conduct of the trial
First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery

The enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. This type of approach has led to an earlier hospital discharge of patients with a low rate of postoperative complications.

Purpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital discharge and domiciliary follow-up for minimal invasive colectomy.

Method: unicenter pilot study of patients with indication of minimally invasive right colectomy or sigmidectomy who will follow an ERAS protocol according to international guidelines and will be discharged the first day of surgery with a domiciliary follow-up. Hospital readmission is considered as the primary outcome. A total sample of 40 cases is considered, with 20 right colectomies and 20 sigmoidectomies. An independent analysis of both techniques will be performed.

Introduction: the enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. The key elements of ERAS protocols include preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization. This type of approach has led to an earlier hospital discharge of patients with a low rate of postoperative complications.

Purpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital discharge and domiciliary follow-up for minimal invasive colectomy.

Method: unicenter pilot study of patients with indication of minimally invasive right colectomy or sigmidectomy who will follow an ERAS protocol according to international guidelines and will be discharged the first day of surgery with a domiciliary follow-up.

Outcomes:

* Primary: hospital readmission
* Secondary: postoperative complications (Clavien-Dindo), domiciliary follow-up mean time before final postoperative discharge, emergency department re-consulting.

Sample: a total sample of 40 cases is considered, with 20 right colectomies and 20 sigmoidectomies.

Analysis: an independent analysis of both techniques will be performed. Pilot study without control branch.

Eligibility Criteria:
Inclusion Criteria:

* Pacients who undergo a minimal invasive sigmoidectomy or right colectomy.
* Benign or malignant desease.
* No expected stoma
* ASA ≤ III
* Family support

Exclusion Criteria:

* Emergency surgery
* Anticoagulant therapy
* Recent immunosupresor therapy (less than one month)
* Anemia (Male Hb \>120 g/L, Female Hb \>110 g/L)
* Malnutrition (Albumine \>35 g/L)
* Dementia
* Moderate or high frailty
* Syncronic neoplasia
* Previous colorectal surgery
The Nutritional Effect of Parental Use of Food as a Reward

Control rules are common parental practices that use food as reward to encourage children to conduct parents' preferred behaviors. This field observational study aims to examine whether control rules are associated with children's increased fat, carbohydrate and total energy intake in everyday eating, and whether this effect is moderated by individual differences in sensitivity to reward, and by gender differences.

Control rules are parental practices that use food as an instrumental reinforcer to encourage children to behave in a normative manner in non-food domains. Since food high in fat or sugar is usually chosen as a reinforcer for control rules, these rules may lead to children's increased preference and every day intake of food high in sugar/fat. Research propositions were examined in 207 six to twelve-year-old children (97 boys and 110 girls). Their parents reported the children's everyday dietary intake through a food frequency questionnaire, and provided information regarding the children's sensitivity to rewards as well as an indication of how frequently they enforce family control rules.

Eligibility Criteria:
Inclusion Criteria:

* participants have 6-12 years old children

Exclusion Criteria:

* N.A.
A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)

This study is to evaluate and compare the effects of Alendronate and Risedronate to treat women with postmenopausal osteoporosis. The primary hypothesis for this study is that in postmenopausal women with osteoporosis, treatment with oral alendronate 70 mg once weekly will produce a mean percent increase from baseline in hip trochanter bone mineral density (BMD) at 12 and 24 months which is greater than that observed with oral risedronate 35 mg once weekly.


Eligibility Criteria:
Inclusion Criteria:

* Women with postmenopausal osteoporosis

Exclusion Criteria:

* Bilateral hip replacements
* Esophageal abnormalities
* Metabolic bone disease (example - Vitamin D deficiency)
* Medications that would affect the breakdown or build-up of bone turnover