cyrilzakka/clinical-trials huggingface dataset:
Atherosclerosis Monitoring and Atherogenicity Reduction Study

This study was designed to estimate the effect of two-year treatment with time-released garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded placebo-controlled randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 40 to 74 years
* Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1100-2000 mcm)
* Arterial normotension or mild arterial hypertension (systolic blood pressure \<160 mm Hg, diastolic blood pressure \<90 mm Hg)
* Absence of chronic diseases demanding permanent drug administration (more than 2 month per year)

Exclusion Criteria:

* Personal history or diagnostic of following diseases:

  1. Transient ischemic attacks
  2. Presence of chronic diseases demanding permanent drug administration (more than 2 month per year)
  3. Condition of patients moderate to severe
* Indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system.
* Individual intolerance of Allicor or appearance of side effects
Yellow Pea Fractions and Short-term Food Intake, Subjective Appetite and Glycemic Response

It is hypothesized that yellow pea protein and fiber will reduce short-term food intake, subjective appetite and glycemic response.

A within-subject, randomized study was conducted. Each subject returned 5 times, 1 week apart, and received 1 of the 5 treatments per week. The 5 treatments were tomato soup with 10 or 20 g of isolated yellow pea fibre or protein, or a control soup with no added pea fractions. Food intake was measured at an ad libitum pizza meal served 2 hours after treatment. Satiety and blood glucose (via finger prick) were measured throughout the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* male 20-30 years old healthy weight

Exclusion Criteria:

* smoking restrictive eating metabolic diseases breakfast skippers dieters
e-BioMatrix 6 Month DAPT France

Prospective, multi-center observational study to be conducted in up to 30 French interventional cardiology centers. The purpose of this observational study is to capture, in French Centers, clinical data of the BioMatrix Flex™ and BioMatrix NeoFlex™ Drug Eluting Coronary Stents System (Biolimus A9, BA9™-) in normal practice, in patients treated with 6-month DAPT, and to compare the outcomes to those of previous e-biomatrix registries with longer DAPT durations. The patients will be followed up for 2 years for data collection.


Eligibility Criteria:
Inclusion Criteria:

* "Real world, all comer" patients

  1. Age ≥18 years;
  2. Patients that need a treatment with a BioMatrix Flex™ drug- eluting stent or a BioMatrix NeoFlex™drug-eluting stent;
  3. Presence of one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents;
  4. No limitation on the number of treated lesions, vessels, and lesion length, within the limits of social security reimbursements;
  5. Patient with DAPT indication after PCI.

Exclusion Criteria:

1. Inability to provide informed consent;
2. Patients needing additional stent NOT of the BioMatrix Flex™ or NeoFlex™ types;
3. Patients receiving next to the BioMatrix Flex™ or BioMatrix NeoFlex™ also other coronary vascular interventions, for example, balloon dilation;
4. Pregnant or planning to become pregnant patient;
5. DES and BMS implantation less than 6 months before screening;
Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.

The purpose of the study is to determine whether T900607-sodium is effective and safe in treating hepatocellular carcinoma, a type of liver cancer.


Eligibility Criteria:
Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of HCC
* Child-Pugh liver classification of A or B
* Subjects must not have received prior chemotherapy or radiotherapy for their HCC
* At least 18 years of age
* Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size.
* Karnofsky performance status of at least 70%
* Estimated life expectancy of at least 12 weeks
* Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive
* Subject must be able to comply with study procedures and follow-up examinations.
* Signed written informed consent
* Lab Values (obtained ≤ 7 days prior to study enrollment):
* ANC at least 1.5x10e9/L,
* Platelet count at least 100x10e9/L,
* Creatinine within 2 times upper limit of normal
* AST and ALT within 5 times upper limit of normal
* Bilirubin within 1.5 times upper limit of normal
* Albumin great than 2.8 g/dL

Exclusion Criteria

* Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment
* NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of \<50%, or acute anginal symptoms
* Patients who have received any investigational agent within 4 weeks of enrollment
* Patients who are pregnant or breast-feeding
* History of prior malignancy other than cancer studied within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* History of central nervous system metastases or carcinomatous meningitis
* Major surgery within 4 weeks of enrollment
* Patients who have received prior chemotherapy, chemoembolization, immunotherapy, or radiotherapy for their HCC. Prior surgical resection, intratumoral ethanol injection, hormonal therapy, cryosurgery, radiofrequency ablation, selective internal radiation or embolization, is permitted ONLY if \> 6 weeks has passed since therapy and there is an indicator lesion (\> 1 x 1 cm) outside the area of prior treatment (recurrence at the margin or resection is allowed)
Risk Factors of Porphyria Cutanea Tarda (PCT)

Comparison of patients with documented PCT and HCV infection, documented PCT without HCV, HCV infection without PCT and controls without HCV or PCT.

Single blood + urine sample uptake to investigate : mutations in HFE gene, uroporphyrinogen decarboxylase activity, HCV genotye, history of disease.


Eligibility Criteria:
Inclusion Criteria:

* Porphyria cutanea tarda /HCV negative Porphyria cutanea tarda/ HCV positive HCV positive HCV negative controls
Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury

In the case of spinal cord injury, rehabilitation is particularly focused on motor skills. Non-motor impairments such as thinking difficulties did not receive a lot of attention to date.

In this research project, the investigators want to find out how thinking difficulties become noticeable in the brain with spinal cord injury.

Participation procedure: Participants who take part will be asked to come to an examination once. The duration of the examination is between 2 and 2.5 hours (including around 55 minutes in the magnetic resonance imaging scanner, including preparation and follow-up).


Eligibility Criteria:
Inclusion criteria (with and without spinal cord injury):

* Male or Female
* Age between 18 and 60
* German native speaker
* Normal or corrected-to-normal visual acuity

Additional inclusion criteria (spinal cord injury only):

* A diagnosis of traumatic spinal cord injury (SCI)
* Time since injury 12 months or longer
* American Spinal Injury Association Impairment Scale (AIS) grade A, B, C and D

Exclusion criteria (with and without spinal cord injury):

* Contraindication for magnetic resonance imaging examinations (e.g., cardiac pacemaker etc.)
* Pregnancy
* Diagnosis of other psychiatric or neurological disorders (including tumor in the central nervous system)
* Alcohol and/or drug abuse
* Confirmed diagnosis of traumatic brain injury
* Insufficient hand function (not able to hold a pen due to the restricted motor abilities)
A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters

To evaluate the performance of GentleCath Glide™ Intermittent Catheters


Eligibility Criteria:
Inclusion Criteria:

* Subjects of 18 years old and above who require intermittent bladder drainage may be recruited into the study
* Subjects must be willing and able to provide written informed consent
* Subjects may be either inpatients or outpatients but must all be capable of completing a patient diary card to record study data
* Subjects must currently use intermittent catheters and have been using intermittent catheters for the last six months
* Patients who self-catheterise at least three times per day
* Able to attend final assessment visit at day 14

Exclusion Criteria

* Subjects who require intermittent catheterisation to administer irrigation or instillation.
* Subjects who are presently participating in another clinical trial.
* Subjects exhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study
* Subjects with known sensitivity to the device components
Balloon Catheter vs. Basket Catheter in Pancreatic Duct Stone Clearance

The aim of the study is to compare the safety and efficacy of the basket catheter with that of the balloon catheter for endoscopic extraction of pancreatic stones.

This is a retrospective cohort study. Patients with chronic pancreatitis who underwent ERCP for pancreatic duct stone extraction using either a basket or a balloon catheter were enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* CP patients with main pancreatic duct (MPD) stones who underwent ERCP

Exclusion Criteria:

* Patients had undergone pancreatic surgery or gastrectomy with Billroth II reconstruction prior to the ERCP procedure
* Patients were suspected of having a malignant tumor
* Patients combined with bile duct stones
* Patients had severe pancreatic duct structure
* Patients with insufficient clinical data
* Patients with previous ERCP treatment
* Patients had received both catheters
International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global)

The International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global), is an international registry of approximately 10,000 healthcare workers in low- and middle-income countries experiencing increasing numbers of COVID-19 cases and commensurate increased exposure to the SARS-CoV-2 virus among their healthcare worker populations.

The registry will enrol HCWs who are experiencing or are expected to experience ongoing and recurrent close contact with confirmed or clinically diagnosed COVID-19 patients. Recruitment for the registry will aim to enrol a representative distribution of HCWs on the front lines of diagnosing and caring for COVID-19 patients in both hospitals and community settings, as well as a balanced sample of HCWs receiving the most commonly administered putatively prophylactic drug regimens.

The registry will collect information on a weekly basis from HCWs across a 12-week period following their first known exposure to confirmed or clinically diagnosed COVID-19 patients prior to or within 30 days after enrollment. Data collection will include the drug regimens being taken by the HCWs, information about their level of exposure to COVID-19 patients, their personal health status, and other factors such as the use of PPE which would likely impact their risk of developing a SARS-CoV-2 infection.

A standard pharmaco-epidemiological inferential analysis will be conducted treating the registry data as a cohort with dynamic exposure to both prophylactic treatment and to COVID-19 infected patients and adjusting for potential confounding. Crude and adjusted hazards ratios will be estimated for each of the prophylactic regimens of interest and any observed impact on the risk of infection among HCWs based on all statistical inferential models will be reported

Eligibility Criteria:
Inclusion Criteria:

Healthcare workers will be entered into this study only if they meet ALL the following criteria:

* Healthcare workers aged ≥ 18 years.
* Healthcare workers must be exposed through ongoing and recurrent contact to a confirmed or clinically diagnosed COVID-19 patient prior to enrollment, or anticipated within 30 days after enrollment.
* Healthcare workers must consent to provide data for the registry and must be willing to be contacted/reminded about data entry at each follow-up time point.
* Healthcare workers must agree to provide a secondary contact for follow-up.

Exclusion Criteria:

* A confirmed SARS-CoV-2 infection or clinically diagnosed COVID-19 prior to the first known exposure to confirmed or clinically diagnosed COVID-19 patient (Index Date).
* Participation in a 'blinded' clinical trial, i.e. unaware of exact treatment received as part of the clinical trial.
Teen Marijuana Check-Up

This study will test a behavioral intervention tailored for adolescents who smoke marijuana and have concerns about their use. The study's purpose is to determine whether this intervention (two-sessions of motivational enhancement intervention followed by 12 months of optional skills training) will be more effective in reducing the use of this drug if augmented by three periodic motivational enhancement treatment check-in sessions as compared to three periodic computer-based check-in sessions.

HYPOTHESES: (1) Participants in the motivational enhancement treatment check-ins (MCI) condition will reduce their use of marijuana more than participants in the computer based (Comp) condition and report fewer negative consequences. These differences are expected to be greater at later follow-ups (i.e, 9, 12, and 15 months) after repeated check-ins exert a cumulative effect. (2)Engagement in CBT sessions will be greater for those in the MCI condition and will partially mediate the effect on marijuana related outcome indices. (3) The MCI intervention will lead to increased self-efficacy, and decreased normative perceptions of marijuana use by other teens that will also partially mediate the effect of the intervention.

The goal of this trial is to evaluate the efficacy of an enhanced Teen Marijuana Check-Up protocol to reach and intervene with non-treatment seeking adolescents who use marijuana heavily. Two hundred fifty adolescents who use marijuana heavily will receive a 2-session individual motivational enhancement therapy. All participants will also be offered the opportunity, over a 12-month period, to repeatedly re-initiate marijuana counseling. Participants will be randomly assigned to receive one of two types of periodic follow-up contacts: Motivational interviewing-based Marijuana Check-Ins (MCI) or Computer Based Control (Comp) sessions.

All participants will be reassessed at the 6, 9, 12, and 15-month anniversaries of enrollment. Following their initial motivational enhancement therapy, the 125 experimental condition participants will additionally have a motivational enhancement treatment "check-in" session with their counselor at the 4, 7, and 10-month anniversaries of enrollment intended to reinforce the maintenance of treatment gains and motivate continued success, increase motivation to change for participants who did not meet their marijuana use goals, and/or prompt utilization of cognitive-behavioral treatment (CBT) sessions as needed. The 125 comparison participants will complete a computer based questionnaire at the same time intervals to serve as an attentional control.

Eligibility Criteria:
Inclusion Criteria:

1. age (14-19 years old),
2. grade level (9th through 11th) and
3. marijuana use.

Exclusion Criteria:

Individuals will be excluded if:

1. they are not fluent in English,
2. they have a thought disorder that precludes full participation,
3. they refuse to accept randomization to condition,
4. they are high school seniors.
A Phase 1 Dose Escalation and Expansion Study Of SHR7280 In Subjects With Hormone Sensitive Prostate Cancer

This is an open-label, multicenter, dose escalation and expansion Phase 1 study of SHR7280 in adult patients with hormone sensitive prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent document；
2. Age ≥18 years old;
3. Histologically or cytologically confirmed prostate adenocarcinoma;
4. Candidate for androgen deprivation therapy (ADT) for the management of hormone-sensitive prostate cancer；
5. Appropriate serum testosterone and serum PSA concentration at screening as specified in the protocol；
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
7. Adequate organ performance based on laboratory blood tests;
8. Agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

1. Previously received gonadotropin-releasing hormone analogues (GnRH-a) for more than 12 months total duration (if GnRH-a was received for 12 months or less, then that GnRH-a must have been completed washout period prior to the first dose of study drug).
2. Patients who have received chemotherapy for prostate cancer;
3. History of surgical castration;
4. Received Abiraterone acetate with 3 months prior to the first dose of study drug;
5. Receieved molecular target therapy, immunotherapy, androgen receptor blockade, 5-alpha reductase inhibitors, estrogen, and other investigational compound with 4 weeks prior to the first dose of study drug;
6. Patients with known or suspected brain metastasis；
7. Diagnosis or treatment for another systemic malignancy within 5 years before study treatment initiation;
8. Patients with uncontrolled and clinically significant hypertension and diabetes;
9. Known hypersensitivity to SHR7280, SHR7280 excipients,；
10. History of immunodeficiency (including HIV infection) or organ transplantation;
11. Known active hepatitis B or C infection;
12. Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
A Study to Test the Performance of the CogState Computerized Neuropsychological Battery in Patients With Alzheimer's Disease (0000-086)(COMPLETED)

This study will evaluate the performance of the CogState computerized neuropsychological battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with mild-to-moderate Alzheimer's disease (AD).


Eligibility Criteria:
Inclusion Criteria:

* Participant is ambulatory, male or female and 55 years of age or older
* Participant has reliable informant/caregiver who can communicate effectively with the study site and personnel

Exclusion Criteria:

* Participant has a history within the last 6 months or current evidence of a psychotic disorder or an active major depressive disorder or participant has any history of schizophrenia
* Participant has a history of multiple and/or serious allergies to drugs or food or a history of an allergic reaction to more than 3 drug classes
Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer

RATIONALE: Giving an infusion of natural killer cells from a donor after a donor stem cell transplant may help kill any remaining cancer cells after the transplant.

PURPOSE: This phase I/II trial is studying the side effects and best dose of donor natural killer cells when given after a donor stem cell transplant in treating patients with advanced cancer.

OBJECTIVES:

Primary

* To assess the safety of donor natural killer (NK) cell infusion after HLA-mismatched/haploidentical allogeneic hematopoietic stem cell transplantation from a familial donor in patients with advanced malignant disorders.
* To determine the maximum number of donor NK cells that can be safely given to these patients.

Secondary

* To assess the clinical efficacy donor NK cell infusion, in terms of tumor response, response duration, and survival, in patients with progressive or recurrent malignant disorders.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

* Phase I: Patients receive an infusion of donor natural killer (NK) cells on days 18 and 21.
* Phase II: Patients receive an infusion of donor NK cells on days 14 and 21. After completion of study treatment, patients are followed periodically.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of a malignant disorder (hematologic malignancies or solid tumors)

  * Advanced disease
* Has undergone prior allogeneic hematopoietic stem cell transplantation (HSCT) from an HLA-mismatched/haploidentical familial donor
* Progressive or recurrent disease, as defined by any of the following (phase II):

  * Peripheral blood blast \> 20% with bone marrow aspirate showing \> 5% leukemic cells (in patients with acute leukemia)
  * Detection of metaphases in the marrow with the same clonal cytogenetic abnormalities as identified before HSCT (or by FISH markers, if appropriate) (in patients with acute leukemia or high-risk myelodysplastic syndromes \[MDS\])
  * Persistent cytopenia with bone marrow aspirate showing various degrees of dysplasia involving ≥ 1 cell lineage (in patients with high-risk MDS)
  * Enlargement of pre-existing measurable lesions by 20% according to RECIST criteria (in patients with solid tumors or lymphoma)
  * Appearance of new metastatic lesions, including pleural effusion or ascites, radiologically typical for metastases or confirmed as such by cytology (in patients with solid tumors or lymphoma)
* Measurable disease (phase II)

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Total bilirubin \< 3.0 mg/dL
* AST \< 5 times upper limit of normal
* Creatinine \< 3 mg/dL
* Not pregnant or nursing
* No clinically evident cardiac or pulmonary failure

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Accuracy of Corneal Astigmatism in Different Region Modes

To analyze the difference between measured total corneal astigmatism and actual corneal astigmatism under different region modes and optimize the region setting.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients who had received phacoemulsification surgery with or without implantation of toric IOL are with a certain amount of corneal astigmatism.
* Best corrected visual acuity ≥ 0.66 (20/30 Snellen)

Exclusion Criteria:

* Corneal diseases or severe irregular astigmatism (e.g., pterygium, keratoconus), existence of corneal opacification;
* Ocular disease which may affect visual acuity (e.g., glaucoma, uveitis, retinal disease, pathologic myopia);
* History of ocular surgery or ocular trauma before this cataract surgery;
* Decentration of IOL \> 0.3mm or tilt \> 5°
* Implantation of multifocal IOL
* history of wearing of rigid contact lens within the past 4 weeks or soft contact lens within 1 week;
Tumour Registry Lung Cancer (TLK)

Overview of treatment reality in patients with bronchial carcinoma requiring systemic treatment and being treated by office-based oncologists in Germany.

The TLK is a prospective, longitudinal, nation wide cohort study that collects data on the treatment reality of patients with NSCLC and SCLC. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Patients are followed until death or for a maximum of 3 years.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed Small Cell Lung Cancer (SCLC), Non Small Lung Cancer (NSCLC) or neuroendocrine tumors receiving therapy
* written informed consent
* start of neoadjuvant, adjuvant or first-line therapy no longer than 4 weeks before informed consent

Exclusion Criteria:

* patients not receiving any systemic therapy