louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01318707: Biomarkers Serum Collection Methodology Pilot Study
Official title: Biomarkers Serum Collection Methodology Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Keywords: Severe Hemophilia A
Hemophilia A Patients
Serum collection vs a method of added FVIII to blood samples
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2011-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe Hemophilia A

Brief summary: The purpose of this study is to compare the standard collection of whole blood in tiger top tubes for serum collection versus a collection method of added FVIII to whole blood samples in the hemophilia population for routine biomarker assays to ensure reliable assay results.

Detailed description: 20 adults with severe Hemophilia A seen in one HTC site for routine blood drawing will be consented for discard blood sampling.

Half of the whole blood discard will be placed in a tiger top test tube, and half of the whole blood discard sample will be placed in a red top test tube containing exogenously added recombinant human FVIII concentrate \[Advate, Baxter immuno\] to assure an end concentration of once IU per CC of whole blood.

Both whole blood specimens will be allowed to coagulate at room temperature and then will be centrifuged to prepare serum. The separated serum from each type of collection test tubes will be aliquoted into eppendorf tubes (a minimum of two aliquots per sample) at a volume of 150 microliters. Aliquoted serum samples will be stored at -70 degrees centigrade and shipped on dry ice to Synarc Labs.

A panel of standard CTX bone resorption assays will be preformed in duplicate on the two differently processed serum specimens obtained from each subject.

Results will be analyzed for inter-subject variability using stored age-matched samples provided by Synarc and intra-subject variability will also be analyzed.

Eligibility criteria: Inclusion Criteria:

* Severe Hemophilia A

Exclusion Criteria:

* If they are not diagnosed with severe hemophilia A.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Lombardi Cancer Center
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Craig Kessler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06555107: Acute Preoperative Pain and Chronic Post-surgical Pain in Emergency Surgery
Official title: Acute Preoperative Pain and Chronic Post-surgical Pain in Emergency Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Postsurgical Pain
Acute Pain
Emergency Surgery
Opioid
Postoperative Pain
Risk Factors
Keywords: risk factors
Chronic Postsurgical Pain
Acute Pain
emergency surgery
opioid
Postoperative Pain
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 693
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Studies evaluating postoperative pain as a risk factor for CPSP are almost exclusively carried out in the context of scheduled surgery. As a result, the preoperative pain studied as a risk factor for chronicity is essentially a state of pain that has persisted for several weeks or even several months.

In emergency surgeries, patients are subject to acute preoperative pain of varying intensity and the duration of which may vary by a few days. A few studies have highlighted the intensity of acute preoperative pain as a factor favouring moderate to severe postoperative pain. At this point, no study has addressed the long-term consequences of this intense preoperative pain the emergency context.

An evaluation in the field of emergency surgery, where the preoperative pain is often intense and limited in time, would enable us to identify more precisely the impact of acute pain on the incidence of CPSP.

The investigators are hypothesising that the occurrence of CPSP at 3 months in patients undergoing emergency orthopaedic or abdominal surgery is associated with acute preoperative pain.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old.
* Emergency orthopaedic and/or abdominal surgery.
* Informed consent.
* Affiliation to a social security scheme

Exclusion Criteria:

* Intraoperative complications that are life-threatening or require the surgical procedure to be discontinued.
* Post-operative intensive care unit admission.
* Ambulatory surgery.
* Endoscopic surgery.
* Repeat surgery at the same site in less that 3months.
* Pregnant or breast-feeding patients.
* Patients under guardianship or deprived of liberty.
* Patients suffering from psychiatric pathologies.
* Patients suffering from neurodegenerative pathologies.
* Patients for whom self-assessment of pain using a numerical scale (0-10) cannot be carried out (non-communicative patients, non-French-speaking patients, and so on).

Primary outcomes:
measure: Frequency of CPSP
timeFrame: at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References:
Clinical trial NCT00949507: Comparison of Two Regimens of Anesthesia for Children Undergoing Magnetic Resonance Imaging (MRI) in General Anesthesia
Official title: Comparison of Two Regimens of Anesthesia for Children Undergoing MRI in General Anesthesia. Advantages, Disadvantages and Time Consumption Regarding the Two Regimens.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Anesthesia
Children
MRI
Sevoflurane
Propofol/Remifentanil
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 children ASA 1-2 aged 1 to 10 yrs. scheduled for MRI in general anesthesia

Brief summary: Comparison of two regimens (Sevorane/LMA ctr. Propofol/Remifentanil) for children undergoing MRI in general anesthesia.


Eligibility criteria: Inclusion Criteria:

* children aged 1 to 10 yrs.
* ASA 1-2

Exclusion Criteria:

* Allergy to soya (propofol)
* Allergy to Pentobarbital
* Allergy to Remifentanil
* Allergy to Sevoflurane
* Children undergoing blood tests or further examinations in conjunction with the MRI
* Children with unexplained fever
* Children which are evaluated not to be able to keep a open airway

Primary outcomes:
measure: postanaesthetic recovery and behavioral score
timeFrame: 0-24 hours hours postoperatively
Secondary outcomes:
measure: Time span of the recovery process
timeFrame: 0-3 hours postoperatively
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup University Hospital, Dept. of Anesthesia
state: Copenhagen
Study officials:
References:
Clinical trial NCT02553707: A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer
Official title: Open-Label Study to Establish the Short Term Efficacy of Intravenous Loading-Doses of Bondronat 6 mg in Patients With Breast Cancer and Skeletal Metastases Experiencing Moderate to Severe Pain, Within 7 Days After Initiation of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-17
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the short term efficacy of ibandronate (6 mg intravenous \[IV\]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and the target sample size is 182 individuals.


Eligibility criteria: Inclusion Criteria:

* Female participants greater than or equal to (\>=) 18 years of age
* Breast cancer with bone metastases
* Pain score of \>=4 on Worst Pain scale of Brief Pain Inventory (BPI)
* Stable analgesic regimen.

Exclusion Criteria:

* Participants who have received a bisphosphonate within 3 weeks of start of trial
* Radiotherapy to bone within 4 weeks of enrolment
* Hypersensitivity to ibandronate
* Central nervous system (CNS) or meningeal metastases

Primary outcomes:
measure: Percentage of participants with >=25% reduction in mean pain
timeFrame: up to Day 6
measure: Percentage of participants with =<35% increase in mean analgesic consumption
timeFrame: up to Days 7
Secondary outcomes:
measure: Change from Baseline in average pain score
timeFrame: Baseline (Days 0), 5, and 7
measure: Analgesic consumption
timeFrame: up to Day 7
measure: Pain response
timeFrame: up to Day 7
measure: Time to pain response
timeFrame: up to Day 7
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Kecskemet
country: Hungary
city: Nyíregyháza
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szombathely
country: Hungary
city: Veszprem
country: Hungary
city: Zalaegerszeg
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT00625807: Comparison of Two Behavioral Treatments for Stress Reduction
Official title: Exploratory Analysis of the Relaxation Response (RR) and Mindfulness Based Stress Reduction (MBSR) for Stress Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Stress
meditation
stress reduction
fMRI
behavioral
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Currently there are 2 popular stress reduction courses that are widely used in the US. Although they use somewhat similar techniques, it is currently unknown whether or not they work the same way, or if they are similarly effective at reducing stress. The study will directly compare these 2 courses. Participants will undergo approximately 4-5 hours of testing before and after each 8-week course.


Eligibility criteria: Inclusion Criteria:

* 25 to 60 years old
* Good general health
* Able to attend all 8 sessions of the course and practice the techniques each night for 25 minutes

Exclusion Criteria:

* Psychiatric medications
* Significant medical or psychological illness
* Metalic implants (such as a pacemaker or artificial joints) that are not MRI compatible.
* Claustrophobia
* Pregnancy
* Previous head trauma or neurological disorder
* Previous experience with yoga or meditation

Primary outcomes:
measure: Brain Activity (fMRI) During the Body Scan Meditation
timeFrame: Week 8
measure: Five Facet Mindfulness Questionnaire
timeFrame: Pre, 8 weeks
measure: Perceived Stress Scale
timeFrame: Pre, 8 weeks
measure: Penn State Worry Questionnaire
timeFrame: Pre, 8 weeks
measure: Anxiety Severity Index
timeFrame: Pre, 8 weeks
Secondary outcomes:
measure: Self Compassion
timeFrame: Pre, week 8
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sara Lazar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06260007: Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia
Official title: Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Oligospermia
Lead sponsor: Herbarium Laboratorio Botanico Ltda
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 204
Sex: MALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety of Products Based on Tribulus terrestris, L. in Men with Oligospermia. It is expected that the benefits of investigational products outweigh the risks that will be mitigated or carefully managed by the study team.


Eligibility criteria: Inclusion Criteria:

1. - Male;
2. - Ages 25 and 60;
3. - Diagnosis of oligospermia;
4. - With sexual partner;
5. - Indication of drug treatment with steroid hormones, precursors or analogues.

Exclusion Criteria:

1. - Severe oligospermia
2. - Anatomical change
3. - Previous treatment for oligospermia or concomitant treatment with steroid, anabolic, hormonal precursors such as testosterone or analogues;
4. - BMI 35;
5. - Participant who presents liver enzyme and creatinine values above the upper limit of normality;
6. - History of testicular cancer, or prostate cancer or any other condition that carries risks in this case increased testosterone;
7. - Hypersensitivity to any ingredient present in the formulation;
8. - Any criteria or clinical history that, in the investigator's opinion, could compromise the well-being and participant safety;
9. - Proven infertility of the partner;
10. - History of genetic disorder;
11. - History of psychiatric disorder, serious or decompensated illness or any situation that, Investigator's discretion, puts the participant's safety at risk;
12. - Active cancer at the discretion of the Investigator;
13. - Participants with pregnant and breastfeeding partners;
14. - Cycling and horse riding more than 3 hours per week;
15. - Alcoholism characterized by the inability to control alcohol consumption according to WHO "drinker excessive, whose dependence on alcohol is accompanied by mental, health and physics, relationships with others and social and economic behavior". Source: https://www.cancer.gov/publications/dictionaries/cancerterms/def/alcoholism;
16. - Smoking greater than half a pack per day or equivalent.

Primary outcomes:
measure: Evaluate the effectiveness of each product in men with changes in their spermogram compared to placebo.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Azidus Brasil Pesquisa Científica E Desenvolvimento Ltda
state: SP
Study officials:
References:
Clinical trial NCT03680807: Power Production in Older Adults With Knee Osteoarthritis
Official title: Power Production in Older Adults With Knee Osteoarthritis Compared to Healthy Counterparts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteo Arthritis Knee
Keywords: Knee osteoarthritis
power production
functional capacity
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults between 50 and 80 years with or without knee osteoarthritis. Subjects are sedentary or recreationally active.

Brief summary: Knee osteoarthritis is an important cause of functional disabilities at old age. Previous research has demonstrated that individuals with knee osteoarthritis have reduced knee-extensor strength in comparison to healthy individuals. However, rapid power production declines more than strength as a consequence of ageing and is more predictive of functional capacity. However, limited research has investigated whether individuals with knee osteoarthritis have reduced ability to develop strength and power rapidly on top of reduced maximal strength capacities, which is the primary aim of the current study.


Eligibility criteria: Inclusion Criteria:

Group with knee osteoarthritis:

- Diagnosed with knee osteoarthritis based on RX.

Exclusion Criteria:

Healthy group:

* Systematic engagement in (resistance) exercise in the 12-months prior to participation
* Cardiovascular disease
* Neurological disorders
* Cognitive malfunctioning
* Severe knee or hip problems

Group with knee osteoarthritis:

* Systematic engagement in (resistance) exercise in the 12-months prior to participation
* Cardiovascular disease
* Neurological disorders
* Cognitive malfunctioning
* Severe hip problems

Primary outcomes:
measure: Rate of power development
timeFrame: up to 3 months
Secondary outcomes:
measure: Maximal isometric strength
timeFrame: up to 3 months
measure: Maximal isokinetic strength
timeFrame: up to 3 months
measure: Stair Climbing performance
timeFrame: up to 3 months
measure: Gait speed
timeFrame: up to 3 months
measure: 5 repetition sit-to-stand test
timeFrame: up to 3 months
measure: Timed-up-and-go
timeFrame: up to 3 months
measure: Handgrip strength
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Movement Sciences
Study officials:
References:
Clinical trial NCT06470607: The Lymphocytic Infiltrate of Lung Tumors.
Official title: Biological Observational Monocentric Study Aimed at Analyzing the Lymphocytic Infiltrate of Lung Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Immune System
Keywords: thoracic tumors
Immune checkpoints
lymphocytes
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is made up of patients diagnosed with thoracic cancer, candidates for surgical resection for the disease.

Brief summary: The study is configured as a monocentric observational transversal biological study.

The main objective of the study is the reconstruction of the molecular organization of tumors of the thoracic cavity, in particular non-small cell lung cancer (NSCLC).

The study involves the collection of clinical data and biological material (blood and tumor tissue) from 70 subjects diagnosed with thoracic tumors.

Detailed description: Inclusion criteria:

The study population will include all patients with the following characteristics:

* Ability to provide informed consent
* Men and women over the age of 18 years old
* Patients candidates for surgical treatment diagnosed with thoracic tumors

The procedures to which the patient will undergo during the study follow the standard of clinical practice for the treatment of pathology.

Exclusion criteria:

* Previous chemotherapy for any cancer within the last 6 months
* Pregnant and/or breastfeeding women
* Immunosuppressive state (states of immunosuppression or ongoing immunosuppressive/immunomodulatory treatments)

The time of observation of the patient for the purposes of the study is limited to the time of hospitalization and the surgical procedure, the patient will therefore perform a single visit to the hospital and there is no provision for the collection of further data following discharge. The study involves a single timepoint of data collection and samples.

The study will have a total duration of 3 years.

Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent;
* Men and women over the age of 18;
* Patients candidates for surgical treatment diagnosed with thoracic tumors

Exclusion Criteria:

* Previous chemotherapy for any cancer within the last 6 months;
* Pregnant and/or breastfeeding women;
* Immunosuppressive state (states of immunosuppression or ongoing immunosuppressive/immunomodulatory treatments)

Primary outcomes:
measure: LYMPHOCYTE ISOLATION
timeFrame: from enrollment in the study to surgery at 15 days
Secondary outcomes:
measure: Lymphocyte gene expression
timeFrame: from surgery to processing within 48 hours
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Scientific Institute Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT04144907: Protein Needs Study
Official title: Innovative Approaches to the Lack of Evidence-based Dietary Protein Requirements for Patients With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Breast Cancer
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Severe muscle loss in patients with cancer has been associated with increased physical disability, extended hospitalization, infectious and noninfectious complications, increased risk of severe toxicity during cancer treatment, poor quality of life and shortened survival. Adequate protein is key to sustain muscle mass and overall health. However, current nutritional recommendations are not specific or evidence-based. The aim of this project is to determine the protein needs of patients with colorectal or breast cancer. Protein needs will be determined using a novel, non-invasive approach. Our results will inform nutritional recommendations and guidelines with the ultimate goal of improving outcomes for people with cancer.


Eligibility criteria: Inclusion Criteria:

* Outpatients age 45-80 years;
* Patients attending the new patient clinic at the Cross Cancer Institute with a diagnosis of colorectal cancer or breast cancer (stages II to III);
* Able to complete baseline visits within approximately 4 weeks of starting chemotherapy OR after a minimum of 4 weeks post-surgery if not undergoing chemotherapy;
* Ambulatory.

Exclusion Criteria:

* Premenopausal women due to impact on protein requirements;
* Received anti-cancer hormone treatment or immunotherapy in the 4 weeks before first baseline visit;
* Renal impairment based on a creatinine clearance for estimated glomerular filtration rate (eGFR) of \<60 mL/min
* Abnormal glucose metabolism based on a fasting glucose level \>6mmol/L and an HbA1c \>5.7% or as reviewed by study team;
* Comorbidities or medications that would interfere with the participants ability to follow the study protocol or the quality of the data(e.g. diabetes, class III obesity, hormone therapy, another active cancer diagnosis);
* Unable/unwilling to provide urine, breath and blood samples (e.g. oxygen tank, catheter, etc.);
* Unable to eat the meals provided (i.e. receiving parenteral or enteral nutrition, severe allergies);
* Substance dependent (e.g. alcohol, cigarettes, illicit drugs) and unable to follow study protocols.

Primary outcomes:
measure: 13C Phenylalanine Oxidation
timeFrame: 8.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Carla Prado, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: