louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06392217: clinIcal Efficacy and Safety of Incadronate in Breast Cancer With Bone Metastases
Official title: Real-world Study of Incadronate in Breast Cancer Patients With Metastatic Bone Disease: clinIcal Efficacy and Safety
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Bone Metastases
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: breast cancer patients with bone metastases

Brief summary: This is a real-world study to explore the efficacy and safety of incadronate in the treatment of breast cancer patients with bone metastases.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18 years or above;
2. Can understand the purpose of clinical trials and the benefits and risks, voluntarily participate in and sign the informed consent
3. The physical status score of the Eastern Cooperative Oncology Group (ECOG) was ≤3;
4. Histologically or cytologically confirmed breast cancer;
5. Imaging or histocytology confirmed bone metastases;
6. There were indications of useing Incadronate and no contraindications in the use of Incadronate;
7. New York Heart Association（NYHA）cardiac function grade ≤II, No serious heart disease;
8. All women of childbearing age, fertile men or their spouses did not plan to have children or donate sperm throughout the trial period until 6 months after the last dose, or voluntarily took effective contraceptive measures.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Patients with acute and chronic infections, or with other serious diseases at the same time, were judged not suitable for this study;
3. Other malignant tumors within 5 years (except the following cases: cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma; A second primary cancer that has been eradicated and has not recurred within five years; Investigators have identified the primary tumor source of the metastases);
4. Mental illness or mental disorder, poor compliance can not cooperate with and describe treatment response;
5. There are serious organic diseases or major organ failure, such as decompensated heart, lung, liver, kidney failure, which can not tolerate treatment;
6. Patients with bleeding tendency;
7. The researcher believes that the patient has other conditions that are not suitable for participating in this study.

Primary outcomes:
measure: The proportion of patients who had at least one Skeletal-related event（SRE）
timeFrame: 12 months
measure: the time to first SRE
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT00287417: Early Ultrasound and Maternal Biochemical Markers to Evaluate the Risk of Down Syndrome During the First Trimester
Official title: Nuchal Translucency Study - PAPP-A
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Down Syndrome
Keywords: Nucal translucency
Down syndrome
MSS
Risk assessment
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-02-06
Enrollment: 20000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinics, public hospitals

Brief summary: The aim of the study is to evaluate the risk of Down syndrome during the first trimester of the pregnancy. The risk assessment is evaluated using early ultrasound and maternal biochemical markers.


Eligibility criteria: Inclusion Criteria:

* Female \> 18 years old
* Pregnant

Exclusion Criteria:

* Maternal age \< 18 years old, twin pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Département de Gynécologie-Obstétrique, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
state: Alsace
city: Strasbourg
country: France
facility: Service de Gynécologie-Obstétrique, SIHCUS, CMCO
state: Alsace
city: Belfort
country: France
facility: Centre Hospitalier
city: Colmar
country: France
facility: Centre Mère et Enfant LE PARC, Service de Gynécologie Obstétrique
city: Guebwiller
country: France
facility: Centre de Périnatalité, Hôpital Civil
city: Mulhouse
country: France
facility: Centre Hospitalier du Hasenrain
city: Strasbourg
country: France
facility: Clinique ADASSA
Study officials:
affiliation: Hopitaux Universitaires de Strasbourg
name: Israel Nisand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01553617: VolulyteTM in Cardiac Surgery
Official title: Efficacy and Safety of Perioperative Infusion of 6 % Hydroxyethyl Starch 130/0.4 in an Isotonic Electrolyte Solution (VolulyteTM) vs. 5% HSA as Volume Replacement Therapy During Cardiac Surgery for Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2012-03-14
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.


Eligibility criteria: Inclusion Criteria:

* male or female adult patients
* undergoing primary elective cardiac surgery applying extracorporeal circulation
* signed written informed consent

Exclusion Criteria:

* known contraindication against scheduled medication
* pre-operative acute normovolaemic haemodilution or preoperative autologous blood donation
* planned systemic hypothermia (body temperature \< 30°C)
* expected time on ECC ≥ 2 hours

Primary outcomes:
measure: Calculated red blood cell loss
timeFrame: up to 3rd postoperative day
Secondary outcomes:
measure: Haemodynamics
timeFrame: up to 3rd postoperative day
measure: Fluid input/output
timeFrame: up to 3rd postoperative day
measure: Use of vasoactive and inotropic drugs
timeFrame: up to 3rd postoperative day
measure: Laboratory parameters
timeFrame: up to day 28 after surgery
measure: Laboratory parameters
timeFrame: up to 3rd postoperative day
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: St. Michael's Hospital, Department of Anaesthesia, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada
name: David C Mazer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03410017: FLI Normative Study
Official title: Normative Data for the Functional Listening Index - Paediatric
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Keywords: Functional Listening Index
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: The Hearing Cooperative Research Centre
name: The Shepherd Centre
First posted: 2018-01-25
Enrollment: 536
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 700 normally-hearing children aged between 0 to 6 years of age.

Brief summary: Single center, cross sectional observational research design to collect normative data on the acquisition of listening skills in normally-hearing children aged 0-6 years of age.

Detailed description: The primary objective is the assessment of listening skill acquisition in normally-hearing children aged between 0 and 6 years with the Functional Listening Index - Paediatric (FLI-P). The FLI-P has been developed to address a substantial gap in the current tools available to measure the development of auditory skills in children. The FLI-P provides a measure of listening skills acquisition in children from birth to six years of age (0 - 72 months). The FLI-P will be administered by an investigator who has received appropriate training in its use or completed by parents/caregivers themselves. The FLI-P assessment will be conducted using an application running on a Personal Computer, tablet or online device. There are no specific medical or surgical procedures involved in this clinical investigation and the FLI-P is a non-interventional application.

Eligibility criteria: Inclusion Criteria:

* Children aged between 0 and 6 years of age.
* Pass on the Newborn Hearing Screen Status conducted during the New South Wales Statewide Infant Screening - Hearing (SWISH) Program.
* No current parental or professional concern regarding hearing status.

Exclusion Criteria:

* Pre-existing diagnosis of additional needs.
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations of the study.
* Unwillingness or inability of the subject to comply with all investigational requirements.

Primary outcomes:
measure: Functional Listening Index
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Milperra
country: Australia
facility: The MARCS Institute Western Sydney University
state: New South Wales
Study officials:
affiliation: The Hearing Cooperative Research Centre
name: Aleisha Davis, MLSP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04005417: Meta-analysis of Stannous Fluoride Dentifrice and the Effects on Dentine Hypersensitivity
Official title: Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dentine Hypersensitivity
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2019-07-02
Enrollment: 1036
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This meta-analysis includes healthy adult male and females.

Brief summary: The aim of this 11 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) on dentine hypersensitivity versus a positive or negative control dentifrice.


Eligibility criteria: Subjects were excluded from this study for the following reasons;

* severe periodontitis
* at discretionary of the Principal Investigator

Primary outcomes:
measure: Change from Baseline Air Challenge
timeFrame: Up to 8 weeks
measure: Change from Baseline in Tactile Threshold
timeFrame: Up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Multiple P&G Investigation Clinical Sites
state: Ohio
Study officials:
References:
Clinical trial NCT00856817: Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atherosclerotic Cardiovascular Disease
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Diabetes Research Foundation
First posted: 2009-03-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether heme oxygenase 1 induction by heme arginate treatment is of influence on adenosine induced vasodilation in healthy individuals.


Eligibility criteria: Inclusion Criteria:

* at least 18 and no older than 65 on the day of first dosing
* healthy
* Quetelet Index (Body Mass Index) of 18 to 30 kg/m2
* In general, results of haematology and chemistry should be within the laboratory's reference ranges. Determinants of renal and hepatic function should be within twice the upper limit of normal range.

Exclusion Criteria:

* Documented history of sensitivity / idiosyncrasy to medicinal products or excipients
* history of smoking within the past year
* history of or current abuse of drugs, alcohol and/or solvents
* Current use of any (over the counter) medication potentially influencing heme oxygenase or the cardiovascular system
* Inability to understand the nature and extent of the trial and the procedures required
* Participation to a drug trial within 60 days prior to the first dose
* Febrile illness within 3 days before the first dose
* Heterozygosity (LS) or homozygosity (LL) with regard to the number of GT repeats in the HO-1 promoter region

Primary outcomes:
measure: Adenosine induced vasodilation
timeFrame: following a three day treatment with either heme arginate or L arginine
Secondary outcomes:
measure: heme oxygenase expression and activity
timeFrame: assessed during and following a three day treatment with either heme arginate or L-arginine
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
References:
Clinical trial NCT02609217: Parents' Expectations and Experiences Around Cesarean Section in Belgium
Official title: Parents' Expectations and Experiences Around Cesarean Section in Belgium
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Section
Keywords: elective
cesarean
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women planned to undergo term elective cesarean section selected from antenatal low-risk clinic.

Brief summary: The aim of this study is to gain insight in the experiences and expectations of Belgian parents concerning primary cesarean section. This will be achieved by structured patient interviews and questionnaires in 24 women undergoing the procedure and their partners. This group will be divided into two subgroups of 12 multiparous and 12 nulliparous women and their partners.

Detailed description: The subjects in both groups will be interviewed twice and will receive three questionnaires. One to two weeks prior to the scheduled cesarean section and during a scheduled obstetric outpatient visit, the first interview and questionnaire will be administered to the couple. A second questionnaire will be provided while still hospitalized (5 days post partum), to both mother and partner. Six weeks post partum, during a scheduled obstetric outpatient visit, the couple will be interviewed for the last time and will be asked to complete the third and last questionnaire.

Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Partner available
* 18-50 years of age
* Singleton pregnancy
* Booked for planned cesarean section ≥37 weeks of gestation
* Dutch-speaking
* Informed consent given

Exclusion Criteria:

* Emergency cesarean section
* \<18 years of age or \>50 years of age
* Multiple pregnancy
* Inability to provide consent (language, etc.)
* Partner not consenting
* BMI \>35 kg/m2
* Maternal or fetal pathologies expected to affect pre and postnatal maternal/neonatal management

Primary outcomes:
measure: Information on parents' fears and expectations around cesarean section
timeFrame: 6 weeks post partum
Secondary outcomes:
measure: Quantitative data on postoperative pain after cesarean section
timeFrame: 6 weeks post partum
measure: Data on the experience of postoperative pain after cesarean section
timeFrame: 6 weeks postpartum
measure: Data on frequency of breastfeeding after cesarean section
timeFrame: 6 weeks postpartum
measure: Qualitative data of breastfeeding after cesarean section
timeFrame: 6 weeks postpartum
measure: Data on the experience of breastfeeding after cesarean section
timeFrame: 6 weeks postpartum
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT04388917: Does the Use of Hemostatic Clips During the Tumor Resection Step Reduce Blood Loss During Robot-assisted Partial Nephrectomy?
Official title: Does the Use of Hemostatic Clips During the Tumor Resection Step Reduce Blood Loss During Robot-assisted Partial Nephrectomy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cancer
Kidney Cancer
Blood Loss
Keywords: robot assisted partial nephrectomy
tips
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consecutive patients who underwent Robot Assisted Partial Nephrectomy

Brief summary: One challenge of robot-assisted partial nephrectomy (RAPN) is to reduce operative blood loss. Partial nephrectomy (PN) is a complex surgery that is being made easier by robotic assistance. In this study, we determined whether the use of hemostatic clips during the tumor resection step reduced blood loss during robot-assisted partial nephrectomy. Methods: In this retrospective study, we included all consecutive patients who underwent RAPN in our university hospital from 2017 to 2019. Three experienced surgeons performed the surgery. One surgeon used Hemo-lock hemostatic clips during tumor resection to prevent bleeding, and two did not. Blood loss in the two groups was compared as the primary endpoint. The duration of clamping, operative time, complications, surgical margins, transfusions, serum creatinine and hemoglobin were compared as secondary endpoints. Results: 53 patients were included, 36 in the No-clip group and 17 in the Clip group. Our two groups were comparable for age, weight, Charlson score, tumor size and RENAL score. There was a significant difference between the two groups for median blood loss 50 mL in the Clip group versus 300 mL in the No-clip group (p = 0.0001), whereas median operating time was shorter in the No-clip group, 140 min versus 180 min for the Clip group (p = 0.044). No other criterion showed a significant difference. The use of Hemo-lock during the tumor resection step in RAPN reduced blood loss without impairing renal function. Larger studies are still needed to confirm our findings.


Eligibility criteria: Inclusion Criteria:

* all consecutive patients who underwent Robot Assisted Partial Nephrectomy

Exclusion Criteria:

* patient off clamping or partial clamping

Primary outcomes:
measure: Blood loss in the two groups was compared
timeFrame: 3 years
Secondary outcomes:
measure: operative time
timeFrame: 3 years
measure: duration of clamping
timeFrame: 3 years
measure: incidence of complications
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03978117: Clinical Trial of Two Study Drinks in Detoxification of Environmental Toxicants and Carcinogens
Official title: Clinical Trial of Two Study Drinks in Detoxification of Environmental Toxicants and Carcinogens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-06
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this research is to determine if consuming one of two study drinks will help enhance the detoxification of multiple environmental toxicants and cancer causing agents, particularly in subjects who are null for glutathione-S-transferase M1 (GSTM1), glutathione-S-transferase T1 (GSTT1), or both. If our research supports this idea, this drink could be an inexpensive dietary component, which could promote good health.


Eligibility criteria: Inclusion Criteria:

* Adult Male or female. Participants can be smokers or non-smokers
* In good physical health
* In stable and good mental health
* Not using any medications that may affect the Nrf2 pathway
* Women who are not pregnant or nursing or planning to become pregnant
* Participants have provided written informed consent to participate in the study

Exclusion Criteria:

* Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
* Vital signs outside of the allotted range
* Not willing to abstain from eating cruciferous vegetables during the course of the study

Primary outcomes:
measure: Effect of study drink Preparation on toxins
timeFrame: 2 Months
measure: Effect of study drink Preparation on carcinogens
timeFrame: 2 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Laboratory Medicine and Pathology, University of Minnesota
name: Stephen Hecht, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00602017: Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 10 mg Amlodipine Besylate Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Chronic Stable Angina
Vasospastic Angina
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Amlodipine Besylate or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Twenty-one day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Charles
country: United States
facility: Gateway Medical Research, Inc.
state: Missouri
Study officials:
affiliation: Cetero Research, San Antonio
name: Steven Herrmann, MD
role: PRINCIPAL_INVESTIGATOR
References: