louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04310033: Impact of ICU on the Quality of Life in Cancer Patients
Official title: Impact of ICU on the Quality of Life and Oncological Care of Patients With Solid Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumor, Adult
Keywords: Quality of life
Oncological care
intensive care unit
solid tumor
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lung, head and neck or colorectal cancer admitted in ICU (cases) or not (controls)

Brief summary: This is an observational, prospective, monocentric, case-control study. Investigators aim to compare the quality of life and oncological treatment strategy in cancer patients admitted or not in ICU.

Detailed description: Inclusion of cancer patients (cases) at discharge of surgical, cardiovascular and thoracic and medical ICU of the Grenoble Alpes University Hospital.

Cases will be matched with cancer patients identified in oncologist's consultation.

Inclusion of controls from oncologist consultations (2 controls for 1 case) For cases and controls, medical data will be collected at inclusion, 3 and 6 months.

Eligibility criteria: Inclusion Criteria:

* \> 18 ans
* Non-opposition of the patient or relatives
* Lung, head and neck or colorectal cancer
* Non scheduled ICU admission
* At least 24 hours of ICU stay
* Alive at ICU discharge
* Able to answer by phone to quality of life questionary

Exclusion Criteria:

* Unable to answer by phone to quality of life questionary
* Patient participating in another clinical study that could interfere with the results of the study

Primary outcomes:
measure: quality of life questionary 36-item short form survey instrument (36-SF)
timeFrame: 3 months
Secondary outcomes:
measure: intensity of antitumoral treatment compared to standard treatment
timeFrame: 3 months
measure: quality of life questionary 36-item short form survey instrument (36-SF)
timeFrame: 6 months
measure: intensity of antitumoral treatment compared to standard treatment
timeFrame: 6 months
measure: ECOG - Performance status
timeFrame: 3 months and 6 months
measure: Activities of Daily Living
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Grenoble Cedex 9
country: France
facility: Chu Grenoble Alpes
Study officials:
References:
Clinical trial NCT00412633: Clinical & Web-based Diet & Activity Counseling for Men
Official title: Clinical & Web-based Diet & Activity Counseling for Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Men
Overweight
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2006-12-18
Enrollment: 442
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PACE Project researchers at UCSD are conducting a 2-year study to test the Men in Motion program. The study aims to learn more about how to help men lose weight, become more physically active, and improve their dietary habits. The study is sponsored by the National Institutes of Health.

Detailed description: This is a randomized controlled trial that will evaluate the effects of a Web-based intervention to improve physical activity and dietary behaviors in overweight and moderately obese men age 25 through 55 years. The study will complement our currently funded NCI project evaluating a similar intervention among overweight female primary care patients. Overweight is related to multiple cancers, CVD, and NIDDM, and the prevalence of overweight is increasing rapidly (NIH 1998). Patient-centered Assessment and Counseling for Exercise plus Nutrition - Internet (PACEi) targets weight-related behaviors and gives patients a tool for addressing these behaviors with their primary care practitioners should they choose to do so. PACEi includes a web-based assessment and progress planning tool, and 12 months of tailored Internet and telephone contact. The components are integrated through a common theoretical framework. Subjects will be randomized to PACEi or to a low intensity intervention.

Eligibility criteria: Inclusion Criteria:

* Subjects will be 360 men age 25 through 55 years with BMIs of 25 to 39.9 (those characterized as "overweight" or "obese I" in the recent NIH report on Obesity).

Exclusion Criteria:

* More severely obese participants will be excluded because they may need more intense behavioral, pharmacological or surgical intervention.

Primary outcomes:
measure: The effect of the intervention on 3 behavioral outcomes: energy expended in moderate and vigorous physical activity during leisure, (b) fruit and vegetable intake, and (c) decreased saturated fat as a percent of energy consumed
timeFrame: 12 Months
Secondary outcomes:
measure: evaluate at 12 months the impact of the intervention on three additional dietary behavior outcomes: (a)fiber intake (b)total energy intake, and (c) total fat as a percent of energy consumed.
timeFrame: 12 months
measure: evaluate the impact of the intervention on physical activity
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: UCSD
name: Kevin Patrick, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04458233: FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study
Official title: FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Nodule
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2020-07-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Ultrasound-guided fine needle aspiration cytology (FNAC) has been proven to be an accurate and efficient tool in thyroid nodule evaluation. Thyroid nodule aspiration is performed by the use of either two techniques; the short axis approach by which only the tip of the needle is observed, or the long axis approach by which the entire needle is observed. Controversial remains of which approach produces better diagnostic adequacy and less non-diagnostic (Bethesda category I) results.

Detailed description: 200 patients presenting electively for thyroid FNA will recruited. Patients will be randomly assigned to two groups: short axis or long axis FNA. FNA will be performed by a single physician at the Ziv medical center ENT clinics.

patient group randomization will be performed according to a random number sequence generated by the SPSS system. Randomization will be performed on admission prior to the procedure.

FNAC sample diagnosis will be performed according to the regular protocol. Laboratory personnel will be blinded to the sample group.

sample results will be compared and analyzed. A P value of less than 0.05 will be regarded as significant.

Eligibility criteria: Inclusion Criteria:

* suspected thyroid nodule requiring diagnostic FNA,

Exclusion Criteria:

* under or above age limit, no informed consent

Primary outcomes:
measure: amount of FNAC non diagnostic Bethesda 1 results
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zefat
country: Israel
facility: Ziv Medical Center
Study officials:
References:
Clinical trial NCT04796233: Patient Perspectives on Advance Care Planning Discussions Prior to Cardiac Surgery
Official title: Patient Perspectives on Advance Care Planning Discussions Prior to Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Surgery
Keywords: Advance Care Planning
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
First posted: 2021-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll patients at Toronto General Hospital, a tertiary cardiac surgery centre in Toronto. We will include patients undergoing any cardiac surgery procedures that involve cardiopulmonary bypass, as well as patients undergoing off-pump coronary bypass procedures and any other high-risk cardiac surgery patients, for example, those undergoing ventricular assist device insertion or pericardectomy.

Brief summary: The purpose of this study is to explore patient perspectives on Advance Care Planning (ACP) prior to cardiac surgery, including perceptions of benefits, drawbacks, and barriers to ACP.

Detailed description: In this study, we plan to interview 40 patients who are scheduled to undergo cardiac surgery about their perspectives on preoperative ACP and discussion of their values, goals of care, and preferences for prolonged care in hospital prior to having surgery. We plan to conduct and audio record one-on-one interviews that are structured around standard questions about ACP. After recordings are completed, we plan to conduct an analysis of the interviews to find common themes and ideas that participants have about preoperative advance care planning. These results will help us understand whether patients value and wish to participate in advance care planning prior to major surgery, and will help to guide the structure and content of preoperative advance care plan programs in the future.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing cardiac surgical procedures that involve a sternotomy, thoracotomy, or cardiopulmonary bypass for any indication.
* Age \> 18
* English-speaking

Exclusion Criteria:

* Emergency surgery, regardless of indication or procedure
* Minor/percutaneous cardiac procedure
* Lack of decisional capacity due to dementia or other neurocognitive dysfunction
* Previously decided upon advance care directives
* Still considering surgery or not yet booked for an operation

Primary outcomes:
measure: Interview
timeFrame: 30-35 Minute interview
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital - University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Michael Tylee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04206033: Hemophilia and Bone Metabolism: Study of Monocytic Populations and Inflammatory Proteins
Official title: Hemophilia and Bone Metabolism: Study of Monocytic Populations and Inflammatory Proteins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia
Osteopenia
Arthropathy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 73
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It will include adult male patients with hemophilia A or B, severe, moderate or minor.

In addition, the investigators will include patients with Hemophilia A with an inhibitor.

Brief summary: The investigators propose, as part of the study, to carry out for each patient:

* An analysis of monocytic populations by flow cytometry (CD14, CD16, CD45, CD68, CD115, CCR2, CX3CR1, CD163 and CD206).
* A population assessment of Myeloid-Derived Suppressor Cells (MDSC).
* Assays of cytokines and chemokines involved in inflammation by multiplex analyzes: Il-1 (α and β), Il-4, Il-6, Il-10, Il-13, TNF- α, TGF- β, CRP , leptin, IFN- β.
* Specialized dosages of proteins involved in bone metabolism. RANKL, osteoprotegerin, M-CSF, TRAPCP5.


Eligibility criteria: Inclusion Criteria:

* Major patients followed at the hemophilia treatment reference center,
* Presenting the diagnosis of severe, moderate or minor Hemophilia A / B,
* Having a social security system,
* Obtaining the oral non-objection collection from the patient after information.

Exclusion Criteria:

* Minor patients, under guardianship or curatorship.
* Causes of secondary osteoporosis:

  * Systemic corticosteroid therapy in progress (≥ 3 consecutive months, at a dosage ≥ 7.5 mg / d of prednisone equivalent).
  * other treatment or condition responsible for osteoporosis: prolonged or medicated hypogonadism, untreated active hyperthyroidism, hypercorticism, primary hyperparathyroidism.
* Treatment with biphosphonates, biotherapies or hormone therapy in the treatment of prostate cancer.

Primary outcomes:
measure: To study the monocytic populations possibly involved in bone metabolism in hemophiliac patients.
timeFrame: 1 year
Secondary outcomes:
measure: Find a correlation between the main objective and the measurement of bone density
timeFrame: 1 year
measure: Find a correlation between the main objective and the measurement of bone density
timeFrame: 1 year
measure: Look for a correlation between the main objective and physical activity
timeFrame: 1 year
measure: Look for a correlation between the main objective and the inflammatory profile in hemophiliac patients.
timeFrame: 1 year
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References:
Clinical trial NCT05412433: Clinic-based HIV Identification and Prevention Project Using Electronic Resources
Official title: Clinic-based HIV Identification and Prevention Project Using Electronic Resources
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
Primary Care
PrEP
Keywords: HIV prevention
PrEP
Cis-gender women
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: National Institute of Mental Health (NIMH)
First posted: 2022-06-09
Enrollment: 1170
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.

Detailed description: Forty-two Obgyn providers will be randomized into 1 of three arms. Patients of enrolled providers who attend an ObGyn clinic for any preventative visit will complete an electronic history form (eHxForm) before clinic through a message sent through the patient portal (MyChart), email, or secure text messaging. The sexual history questions will be scored and categorized into 3 categories. Patients with a low score (0-3) will receive an electronic message offering a laboratory HIV test per USPSTF guidelines. If she accepts, then an automated Epic order will be placed for the provider to sign during the office visit.

Patients with a medium/high score (4-10) will be assigned a study arm based on their provider's group (arm 1: control, arm 2: patient will view score and a PrEP video, arm 3: procedures in arm 2 PLUS providers will receive an electronic health record alert that the patient may have HIV risk factors. This will occur automatically via programming integrated into the electronic health record. The primary outcome is PrEP uptake. The implementation strategy will be evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Eligibility criteria: Inclusion Criteria:

* Patients of enrolled providers aged 15-65 years
* Presenting for preventive care (i.e., well-woman exam, sexually transmitted infection testing, pre-conception counseling, or birth control).

Exclusion Criteria:

* Pregnant and has established prenatal care, i.e., visit is for prenatal care
* Non-English or non-Spanish speaking
* Living with HIV
* Unable to complete the eHxForm

Primary outcomes:
measure: Number of PrEP prescriptions written for each patient
timeFrame: 4 weeks
measure: Adoption of Electronic History Form
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Health System
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jenell Coleman, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00631033: DZX Mediated Insulin Suppression in Obese Men
Official title: Diazoxide-mediated Insulin Suppression in Hyperinsulinemic Obese Men, Part III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: obesity
hyperinsulinism
diazoxide
metformin
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2008-03-07
Enrollment: 51
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether there is an additive effect of metformine on the weight reduction of obese hyperinsulinemic men who are treated with diazoxide.


Eligibility criteria: Inclusion Criteria:

* male
* age 25-50 years
* BMI 30-35 kg/m2
* stable body weight during 3 months before the start of the study
* glucose \<= 6.0 mmol/L
* C-peptide \>= 1.0 nmol/L
* HbA1c \<= 6.0%

Exclusion Criteria:

* comorbidity
* medication
* serum creatinine \> 120 micromol/L
* liver enzymes \> 2 times upper limits of normal
* gout
* alcohol use \> 2 alcoholic drinks a day
* drug abuse
* cessation of smoking less than 6 months ago

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
References:
citation: Loves S, van Groningen L, Filius M, Mekking M, Brandon T, Tack CJ, Hermus A, de Boer H. High-Dose, Diazoxide-Mediated Insulin Suppression Boosts Weight Loss Induced by Lifestyle Intervention. J Clin Endocrinol Metab. 2018 Nov 1;103(11):4014-4022. doi: 10.1210/jc.2018-01147.
citation: Loves S, van Groningen L, Filius M, Mekking M, Brandon T, Tack CJ, Hermus A, de Boer H. Effects of Diazoxide-Mediated Insulin Suppression on Glucose and Lipid Metabolism in Nondiabetic Obese Men. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2346-2353. doi: 10.1210/jc.2018-00161.
Clinical trial NCT02010333: A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation
Official title: A Pediatric Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head Lice Infestation
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2013-12-12
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is to evaluate safety and tolerability of a single application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric population.


Eligibility criteria: Inclusion Criteria:

1. Male or female, 6months \< 3years of age
2. Good health
3. Active head lice infestation defined as the presence of at least 3 live lice
4. Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation)
5. Parent/guardian agrees to allow PK samples collected
6. Signed Informed Consent Form

Exclusion Criteria:

1. Condition or illness that in the opinion of the investigator may interfere with the study results.
2. Current dermatological disease that may compromise the health of subject or the assessment of safety. Subjects with scalp ulceration or evidence of scalp infection should not be enrolled.
3. Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
4. Receiving systemic or topical medication that may interfere the study results.
5. Received an investigational agent within 30 days prior to Day 0.

Primary outcomes:
measure: Safety and tolerability of Ha44 Gel
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dinuba
country: United States
facility: Universal Biopharma Research Institute
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
Study officials:
References:
Clinical trial NCT04536233: Effects of MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries
Official title: The Safety and Effectiveness of Mesenchymal Stem Cell-derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nasal trauma, deviated nasal septum, sinusitis, nasal polyps and other nasal benign diseases are common clinical diseases and require endoscopic sinus surgery. The proper application of the surgical procedure as well as ensuring high quality of wound healing, is also important to achieve successful results in endoscopic sinus surgery. If good quality wound healing cannot be achieved in the surgical field,synechiae and anatomic defects can occur that may require revision surgeries.

Mesenchymal stem cells play an active role in the treatment of many diseases. it primarily exerts therapeutic effects through paracrine. In this study, the effect of mesenchymal stem cell-derived multipotent factors on mucosal repair after nasal surgery was evaluated.


Eligibility criteria: Inclusion Criteria:

1. 18 to 60 years old;
2. The clinical diagnosis is nasal trauma, nasal septum deviation, sinusitis, and nasal polyps requiring endoscopic surgery;
3. The patient's physical and mental state is stable, and he can return to the hospital regularly for follow-up examinations and cooperate to complete the experiment;

Exclusion Criteria:

1. Younger than 18 or older than 60;
2. Clinical diagnosis of nasal malignancies, or uncontrolled severe infectious diseases;
3. Past medical history of mental illness, malignant tumor, nose surgery;
4. People with serious underlying diseases (hypertension, diabetes, rheumatism, asthma) require long-term medication;
5. Long-term smoking, more than 5 cigarettes per day;
6. Work or daily life environment is exposed to large amounts of dust and chemical raw materials;

Primary outcomes:
measure: Wound healing evaluation
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: