cyrilzakka/clinical-trials huggingface dataset:
Continued Treatment With Docetaxel Versus Switch to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in Patients With Castration-Resistant Metastatic Prostate Cancer

Primary Objective:

* To compare the continuation of treatment with docetaxel versus switching to cabazitaxel regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of docetaxel, have minor PSA response (defined as a reduction between 1% and 49%) or increase of up to 24% in PSA levels.

Secondary Objectives:

* PSA response rate
* Overall survival (OS)
* Incidence of Adverse Events

Screening: 21days (+7 days) Treatment: until PSA progression Post-treatment Follow-up: 2 years

Eligibility Criteria:
Inclusion criteria :

* Documentation of histological prostate cancer;
* Patients with metastatic CRPC (Castration-Resistant Metastatic Prostate Cancer) who progressed with hormone deprivation, including the withdrawal of antiandrogen-class drugs for at least 4 weeks, and 6 weeks for bicalutamide or if documented that PSA did not decrease during 3 months of this therapy;
* Documentation of metastasis by imaging (computerized tomography \[CT\], magnetic resonance imaging \[MRI\] or bone scan), in patients with PSA \< 20 ng/mL at the time of inclusion
* Provide minor PSA response (characterized by a reduction between 1% and 49%) or increase up to 24% in PSA levels, in relation to the value measured before starting docetaxel therapy, measured at least 7 days after the fourth cycle of docetaxel;
* Patient has received 4 cycles of docetaxel at a dose of 75 mg/m2 ;
* ECOG performance status of 0 or 1;
* Marrow, liver and renal function within acceptable values;
* PSA ≥ 2 ng/mL;
* Testosterone level ≤ 50 ng/dL (for patients with no prior history of orchiectomy).

Exclusion criteria:

* Prior use of chemotherapy, except for docetaxel for four cycles;
* Documented disease progression during treatment with docetaxel (first 4 cycles);
* Patients with metastases resulting in neurological damage;
* Inability to continue receiving gonadotropin-releasing hormone agonists in patients with no prior history of orchiectomy;
* Use of recombinant methionyl human granulocyte-colony stimulating factor non-glycosylated (G-CSF) in the 24 hours preceding baseline;
* Any other current neoplasia or over the past 5 years, except for basal cell skin carcinoma or squamous skin cell carcinoma;
* Known seropositivity for HIV (Human immunodeficiency Virus );
* Concomitant diseases, such as significant neurological or psychiatric disease; uncontrolled hypercalcemia or any other serious comorbidity;
* Hypersensitivity or allergy to any of the study treatments.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Effects of Short-term Interventions for a Healthy Lifestyle on the Human Lipidome in Subjects With Metabolic Syndrome

A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now.

"GesundLeben" will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. Standardized metabolic assessment will be covered with routine laboratory parameters and oral glucose tolerance test as well as non-radiologic anthropometric measurements.

A growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. However, data on this issue is still sparse and especially interventional data is not available up to now. We intend to clarify, if the human lipidome is correlating with metabolic state and if changes in this state reflect on the lipidome. Using high-throughput shot-gun technique, we will be able to measure several hundreds of lipid species in one blood sample.

The "GesundLeben" trial will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. The cohort will be designed to include participants from both sexes, but be restricted on subjects without impaired glucose tolerance.

Standardized metabolic assessment will be covered with routine laboratory parameters (e.g. transaminases, HbA1c) and oral glucose tolerance test as well as non-radiologic anthropometric measurements (BMI, WHR, BIA).

Eligibility Criteria:
Inclusion Criteria:

* hypertension
* NAFLD
* obesity
* hyperuricemia
* dyslipoproteinemia

Exclusion Criteria:

* prediabetes / overt diabetes mellitus
* present cancer
* systemic infection
* chronic inflammatory disease
* recent stroke / myocardial infarction (6 months)
* pregnancy
* addiction / severe psychiatric diseases
Influence of the Communication Between Nursing Staff and Patients on the Analgesic Response Following Caesarean Section

Effective management of postoperative pain is a priority for women undergoing cesarean delivery. Despite availability of modern analgesics, postoperative pain management remains a challenge.

One opportunity to enhance the analgesic effect of the pharmacological treatments given to people suffering from pain (and not just pain) is through increasing the expectations for pain relief following treatment. Although much knowledge has been accumulated about the significant effect of expectations on pain, virtually all evidence are based on experimental studies carried out in laboratory settings, and there is a need to investigate how this knowledge could translated into improved clinical care.

The aim of the current study is to examine whether the communication style between the nursing staff and the patient during analgesic administration will affect the results of pain relief treatment in the mother-newborn ward after cesarean section. As another goal, the study will examine whether relevant patient's characteristics will predict the effectiveness of the treatment.

The study will be carried out in the maternity ward at Carmel Hospital. The study population will include patients who are about to undergo an elective caesarean section under spinal anesthesia. The recruitment will be done pre-surgery. Following consent, participants will receive an explanation about how to assess pain and will fill out the research questionnaires. Communication is the independent variable in this study , which has 2 levels - the increased communication arm and the normal communication arm. Each arm will include 40 patients that will be randomly divided between the arms. The dependent variable is the treatment efficacy, based on the changes in the intensity of the patient's pain one hour after the administration of analgesic. The Self-Consciousness Scale (SCS-R) and the Short suggestibility scale (SSS) will be used to assess relevant personality traits.

Eligibility Criteria:
Inclusion Criteria:

* Be able to provide signed and dated written informed consent and to be compliant with the schedule of protocol assessments.
* Females aged 18 till 50
* Undergoing cesarean section

Exclusion Criteria:

\* Mental retardation and cognitive impairment

study.
Using Multifamily Groups to Improve Self-Management of Type 2 Diabetes

The overall objective of this study is to construct an adaptive intervention that integrates family members and patients as partners in care while promoting diabetes self-management for Mexican Americans with Type 2 diabetes. The project incorporates four evidence-based, culturally tailored treatments using a Sequential, Multiple Assignment Randomized Trial to help determine what sequence of intervention strategies work most efficiently and for whom.

The project evaluates four culturally adapted, family-based treatments designed to improve health status, self-management behaviors and self-efficacy among Mexican-Americans with Type 2 diabetes using a Sequential, Multiple Assignment Randomized Trial in a public health setting. In the first phase of the study, subjects will be randomly assigned to six 2.5 hour sessions (three months) of either: 1) Tomando Control de su Diabetes (TC), a culturally tailored, community-based, Diabetes Self-Management program delivered in a group format by community health workers (promotoras) working with individual patients and families; or 2) TC delivered by health professionals (licensed nurses). Evaluations will be made at baseline, three months, six months and 12 months. After six weeks of treatment (at the midway point of the intervention), subjects will be assessed for improvement in diabetes self-management behaviors (the primary outcome). In the second phase of the study, those subjects who have improved their diabetes self-management behaviors by 50% over baseline will be continued in their assigned treatment for the duration of three months. Those subjects who do not meet this target will be re-randomized to receive either: 1) an augmented version of TC that has a specific focus on engaging family members; or 2) a multifamily group treatment led by nurses specially trained in teaching diabetes self-management skills for an additional three months.

Eligibility Criteria:
Inclusion Criteria:

1. Mexican origin and speaks Spanish fluently
2. age 18 years or older
3. medical chart diagnosis of Type 2 diabetes
4. living with at least one adult family member who is willing to participate.

Exclusion Criteria:

1. diagnosis of Type 1 diabetes
2. participation in another Diabetes Self-management education program within the past 12 months
3. pregnancy
4. significant cognitive impairment.
The Effect of Berry Extract Administration on Cognitive Health

The purpose of this study is to investigate the effects of daily supplementation of Brainport for a period of 6 months on cognitive health.


Eligibility Criteria:
Inclusion Criteria:

* healthy individuals
* Age between 40 and 60 years
* BMI 25 - 35 kg/m2

Exclusion Criteria:

* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat). Dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and /or laboratory assessments that might limit participation in or completion of the study protocol.
* Diabetes
* Use of medication that might have influence on endpoints (hypertension medication)
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to the study
* Use of antibiotics in the 30 days prior to the start of the study
* Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
* Pregnancy, lactation
* Abuse of products (\> 20 alcoholic consumptions per week and drugs)
* Smoking
* Weight gain or loss (\> 3 kg in previous 3 months)
* High physical activity (\>4.5 hours of running/week)
* History of any side effects towards intake of berries
Optimal Feeding Tube Placement

A randomized controlled trial comparing current standard blind method to CORTRAK enteral access system (CEAS), an FDA approved electromagnetic device to place enteric tubes.

Patient population would include patients in pediatric intensive care unit, pediatric cardiac unit, intermediate medical care unit and pediatric floor who receives postpyloric feeding tube placements. The study team are going to monitor total time and number attempts required for each successful placement, correlation of findings on x-ray versus CEAS, cost-effectiveness of this new equipment with standard blind method and decrease in radiation exposure with CEAS.

Eligibility Criteria:
Inclusion Criteria: Patient admitted to pediatric floor, intermediate care unit, pediatric intensive care unit, or congenital care unit requiring post-pyloric feeding tube placement of size eight french or more and not meeting any of exclusion criteria

Exclusion Criteria: Under three kilograms, Open chest wall, Open abdominal wall
Drug /Cue Interactions In Alcohol-Tobacco Comorbidity

The purpose of this study is to determine how people react to different combinations of alcohol and nicotine.

The present project will improve and expand upon previously published work in several ways. First, Study 1 will assess reactivity to alcohol and smoking cues in the same session. Second, both studies will include within-subjects design factors to manipulate alcohol and nicotine intake, as well as cue types. Third, craving indices will represent three important response domains: subjective, physiological, and behavioral (e.g., Niaura et al., 1991). Fourth, each study will evaluate a range of drinkers and smokers, which will provide maximal information concerning influences on alcohol and smoking cue reactivity across various subject populations. The proposed studies are not only important from a theory development perspective, but they will provide an excellent foundation for future laboratory-based and clinical research.

Eligibility Criteria:
Inclusion Criteria:

* English speaking persons who exhibit a range of alcohol consumption and smoking patterns.
* Signed written consent form.

Exclusion Criteria:

* Females who are pregnant, nursing, or not using effective methods of birth control will be excluded from participating.
Growth and Development Study of Alglucosidase Alfa

Pompe disease (also known as glycogen storage disease Type II) is a rare autosomal recessive metabolic muscle disease caused by the deficiency of acid α glucosidase (GAA), an enzyme that degrades lysosomal glycogen. As opposed to the exclusively cytoplasmic accumulation of glycogen that occurs in other glycogen storage disorders, Pompe disease is characterized by organelle bound (lysosomal) and extra-lysosomal accumulation of glycogen in many body tissues, ultimately leading to multisystemic pathology. The overall objective of this study was to evaluate the long-term growth and development of participants with infantile-onset Pompe disease with alglucosidase alfa before 1 year of age. Participants were to be followed for a 10-year period.


Eligibility Criteria:
Inclusion Criteria:

* The participant or participant's legal guardian must have provided signed, informed consent prior to performing any study-related procedures.
* The participant must have had a confirmed diagnosis of Pompe disease as determined by deficient endogenous GAA activity or GAA mutation analysis.
* The participant must be less than (\<) 1 year of age at time of study enrollment (and received alglucosidase alfa treatment before 1 year of age), or the participant must be between 1 year and 24 months of age and must have had initiated alglucosidase alfa treatment prior to turning 1 year of age.

Exclusion Criteria:

* The participant was participating in another clinical study using alglucosidase alfa or any investigational therapy.
A Study in Adolescent Females to Explore Cytomegalovirus Infection

The purpose of this study is to estimate the incidence of Cytomegalovirus (CMV) secondary infections (re-infections/re-activations) and the incidence of CMV primary infections in adolescent females.


Eligibility Criteria:
Inclusion Criteria:

* A female adolescent between, and including 10 and 17 years at the time of enrolment regardless of pregnancy status and contraception method used or not used.
* Subjects who the investigator believes that the subject and/or the subject's parent(s)/Legally Acceptable Representative(s) (LAR\[s\]) can and will comply with the requirements of the protocol.
* Written informed assent and/or consent obtained from the subject and/or the parent(s)/LAR(s) of the subject.
* Subject is likely to remain in the area and/or return for required study Site Visits and complete Sample Collection Visits.

Exclusion Criteria:

* Child in care.
* Use or planned use of any investigational or non-registered antiviral drug or vaccine during the study period.
* Known medical history of any recurrent clinical herpes episodes requiring episodic or chronic suppressive treatment with oral or parenteral antiviral treatment such as acyclovir, famciclovir, valacyclovir or any other anti-herpes virus anti-viral during the year preceding enrolment. Topical anti-viral are allowed.
* Subjects with history of previous vaccination against CMV.
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to Visit 1 or planned administration during the study. Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/or any blood products within 3 months prior to Visit 1 or planned administration during the study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition including HIV-infection, based on medical history and physical examination (no laboratory testing required).
* Any major congenital defects, serious chronic illness or organ transplantation.
Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer

This is a first-in-human (FIH), open-label, phase 1 dose-escalation study of KN026 in subjects with HER2 positive advanced breast and Gastric Cancer. The standard "3 + 3" design was used for dose escalation. There are 5 proposed dose levels which are 5, 10, 15, 20 and 30 mg/kg, but dosing interval may be adjusted during the study (such as QW, OR Q2W, OR Q3W) based on emerging data from this trial and/or from phase 1 trial of KN026 in other country. Dose escalation will continue until the maximum tolerated dose (MTD) is reached or if MTD is not found, dose escalation will continue until the MAD of 20 mg / kg is reached. Dose expansion will carried out in 20 mg/kg Q2W and 30 mg/kg Q3W.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject \>= 18 years and =\<75 years.
* Histologically or cytologically confirmed, locally advanced unresectable or metastatic breast cancer or gastric cancer.
* ECOG score 0 or 1.
* Life expectancy \>3 months.
* According to the definition of RECIST1.1, the patient has at least one measurable lesion.
* Adequate organ function prior to start treatment with KN026.
* Able to understand, voluntarily participate and willing to sign the ICF.
* Subjects (women of child-bearing potential and males with fertile female partner) must be willing to use viable contraception method.

Exclusion Criteria:

* Accepted any other anti-tumor drug therapies within 4 weeks before fist dose.
* Accepted radiotherapy within 4 weeks before enrollment(Subjects are eligible, which accepted palliative therapies within 2 weeks before the first dose of KN026 for osseous metastatic and all the AEs recovered).
* An anthracyclines antibiotic treatment, such as doxorubicin (Adriamycin) was received exceeding 300 mg/m² within 90 days before first KN026 dosing, or other equivalent dose antharcyclines.
* Subjects are eligible with clinically controlled and stable neurologic function \>= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible.
* Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study.
* Has not recovered (ie, \>Grade 1) from AEs except alopecia and anemia.
* History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
* Severe chronic and active infection, need to system antibiosis/antiviral treatment.
* Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage. -
Reducing Acute Coronary Syndrome Patient Delay

1. To test the effectiveness of the theory-based interventions (text+visual and text-only BCT-based interventions) against usual care in changing patients' intentions to phone ambulance immediately with symptoms of ACS ≥ 15 minutes duration.
2. To determine the most effective mode of delivery by comparing the text+visual BCT-based intervention with text-only BCT-based intervention.
3. To investigate any unintended consequences of the intervention on intentions to phone an ambulance for non-life-threatening symptoms.

Patient delay means many people do not achieve optimal benefit of time-dependent treatments for Acute Coronary Syndrome (ACS). Reducing delay would reduce mortality and morbidity but to date, interventions to change behaviour have had mixed results. Systematic inclusion of behaviour-change techniques (BCTs) or a visual mode of delivery might improve the efficacy of interventions.

Aim To evaluate the efficacy of a BCT-based intervention and to compare two possible modes of delivery (text+visual and text-only).

Design A 3-arm web-based, parallel randomised, controlled trial of a theory-based intervention.

Methods and analysis The intervention comprises 12 BCTs systematically identified following systematic review and a consensus exercise undertaken with behaviour change experts. We aim to recruit n=177 participants who have experienced ACS in the previous 6 months from a local National Health Service (NHS) Teaching Hospital. Participants will be identified by Cardiac Rehabilitation staff and invited by letter to take part in the study. Those who wish to take part will be asked to access the experiment at a secure web-address and consent re-checked. Consenting participants will be randomly allocated in equal numbers to one of three study groups: i) usual care ii) usual care plus text-only BCT-based intervention or iii) usual care plus text+visual BCT-based intervention. The outcome variable will be the change in intention to phone an ambulance immediately with symptoms of ACS ≥15 minutes duration assessed using two randomised series of 8 scenarios representing varied symptoms before and after delivery of the interventions or control condition (usual care).

Eligibility Criteria:
Inclusion Criteria:

* Adults, aged \> 18 years
* Experience of Acute Coronary Syndrome within the previous six months

Exclusion Criteria:

* Anyone still hospitalised
* People who have experienced ACS within the previous two weeks.
Effect of Contouring Techniques on CMR Assessment of the Right Ventricle in Repaired Tetraology of Fallot

Patients with repaired tetralogy of Fallot (RTOF) develop chronic pulmonary regurgitation and require monitoring for right ventricular dilatation. Pulmonary valve replacement can prevent irreversible right ventricular (RV) dilatation and dysfunction and cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. The investigators sought to determine whether the choice of myocardial contouring technique affects preoperative RV volumetric thresholds for intervention.

Participants with repaired tetralogy of Fallot (RTOF) will be identified using existing patient electronic records who have developed chronic pulmonary regurgitation and are undergoing monitoring for right ventricular dilatation. Cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. Pulmonary valve replacement can prevent irreversible right ventricular (RV) dilatation and dysfunction and cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. There are different post-processing techniques published for measuring RV volumes on cardiac magnetic resonance imaging (detailed vs. smoothed and manual vs. automated). The primary aim of this study is to identify whether the choice of myocardial contouring technique affects the preoperative RV volumetric thresholds for intervention. As a secondary aim, the investigators will determine the reproducibility of different contouring methods.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with repaired Tetralogy of Fallot undergoing routine clinical surveillance at a Level 1 ACHD surgical referral centre.

Exclusion Criteria:

* None