louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04039425: Effects of Chemotherapy on the Concentration of Minerals in Hair
Official title: Effects of Chemotherapy on the Concentration of Minerals in Hair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 5
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: Subjects diagnosed with any type of cancer, Stages 1, 2 or 3, assigned to receive immunosupressive chemotherapy treatment.

Brief summary: The purpose of the investigator's graduate student research study is to investigate if there are significant changes in hair mineral levels in cancer patients undergoing chemotherapy.

Detailed description: Visit 1 - Before the start of chemotherapy

* Complete a questionnaire about demographics, health, and diet.
* Weight and height will be measured.
* A small sample of the participant's hair will be collected from the back side of the head near the base of the neck. Only the hair in the first inch closest to the scalp will be included in the sample. This hair sample will weigh 0.25g to 1g, which is about the same weight as one to two regular paper clips.
* The participant will be given a food frequency questionnaire

Visit 2- Approximately 2 months after start of chemotherapy

* The participant will complete a questionnaire about their health and diet.
* weight and height will be measured
* A small sample of the participant's hair will be collected from the back side of the head near the base of the neck. Only the hair in the first inch closest to the scalp will be included in the sample. This hair sample will weigh 0.25g to 1g, which is about the same weight as one to two regular paper clips.
* The participant will be given a food frequency questionnaire.

Eligibility criteria: Inclusion Criteria:

* Are 18 years and older
* Recently diagnosed cancer stage 1, 2, or 3
* Assigned to receive immunosuppressive chemotherapy treatment
* Natural hair that has not been dyed or permed in the past 3 months

Exclusion Criteria:

• Prior chemotherapy treatment for cancer

Primary outcomes:
measure: hair mineral levels(ug/g)
timeFrame: change between visit 1(baseline/start of chemotherapy) and visit 2 (about 2 months after visit 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Edward Bitok, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05149625: Comparison of the Efficacy and Satisfaction of Blood Glucose Management Between Continuous Glucose Monitoring Versus Traditional Self-blood Glucose Measurement in Diabetic Patients After Pancreatectomy
Official title: Comparison of the Efficacy and Satisfaction of Blood Glucose Management Between Continuous Glucose Monitoring Versus Traditional Self-blood Glucose Measurement in Diabetic Patients After Pancreatectomy : A Randomized Controlled Open Labeled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 172
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to compare the efficacy and satisfaction of blood glucose management between continuous glucose monitoring versus traditional self blood glucose measurement in diabetic patients after pancreatectomy.

Detailed description: Patients will be enrolled after the 75g oral glucose tolerance test performed 7 days after pancreatectomy. Patients will be divided into two groups by randomization (continuous glucose measurement method vs. traditional self blood glucose measurement method), and 3months after surgery, HbA1c, hypoglycemic events, and satisfaction would be compared.

Eligibility criteria: Inclusion Criteria:

* Patients over 19 years of age
* Preoperative diabetes history
* Patients who underwent subtotal or total pancreatectomy
* Patients who were diagnosed with diabetes mellitus in the evaluation of endocrine function test on the 7th day after pancreaticoduodenectomy, central pancreatectomy, or distal pancreatectomy

Exclusion Criteria:

* Patients who have used continuous blood glucose measurement device more than once before.
* Elderly patients who are not accustomed to using the smartphone applications
* Serious systemic diseases that can affect diabetes (chronic kidney disease, heart failure, decompensated liver cirrhosis, etc.)
* Steroid user during the study period
* Major medical or psychiatric condition that will affect response to treatment

Primary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: postoperative 3months
Secondary outcomes:
measure: Hypoglycemic events
timeFrame: postoperative 3months
measure: satisfaction survey
timeFrame: postoperative 3months
measure: Fasting, postprandial plasma glucose
timeFrame: postoperative 3months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Seoul National University College of Medicine
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Young Jang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05564325: Real-time Deflectable Guidewire in Neuro-interventions Study
Official title: Real-time Deflectable Guidewire in Neuro-interventions Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unruptured Cerebral Aneurysm
Lead sponsor: Artiria Medical
Sponsor class: INDUSTRY
First posted: 2022-10-03
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to assess the safe and successful use of the SmartGUIDE guidewire in neuro interventions and to compare to standard of care guidewires on the market.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Informed consent signed by patient
* Confirmed cerebral unruptured aneurysm treatable via transcatheter approach

Exclusion Criteria:

* Pregnancy or lactation
* Known disorder of vascular fragility with propensity to vascular injury (e.g., Ehlers-Danlos syndrome)
* Known prior vascular stenosis or dissection or injury to vessels intended to be catheterized during study procedures
* Acute phase myocardial infarction or uncontrolled cardiac arrhythmia
* Uncontrolled serum electrolyte imbalance
* Bleeding disorder which limits the use of antiplatelet and/or anticoagulant therapy
* Known contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
* Known hypersensitivity to Nickel
* Subjects currently enrolled in another investigational device or drug study that clinically interferes with the current study endpoints

Primary outcomes:
measure: Performance
timeFrame: During index procedure
Secondary outcomes:
measure: Usability
timeFrame: During index procedure
measure: Procedural times
timeFrame: During index procedure
measure: Safety - intra- and postprocedural
timeFrame: During index procedure and up to 48 hours post procedure
measure: Device Deficiencies
timeFrame: During index procedure
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital - HUG
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
Study officials:
affiliation: Geneva University Hospital - HUG
name: Paolo Machi, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05833425: Is Respiratory Muscle Strength, Peripheral Muscle Strength and Postural Control Affected in Scoliosis?
Official title: Is Respiratory Muscle Strength, Peripheral Muscle Strength and Postural Control Affected in Adolescent Idiopathic Scoliosis?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Scoliosis
Adolescent Idiopathic Scoliosis
Respiratory Muscle Strength
Peripheral Muscle Strength
Postural Control
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 36
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It was calculated that at least 36 patients in total, 18 patients in the scoliosis and healthy groups, should be included in the study.

Brief summary: The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates.

Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. Children with adolescent idiopathic scoliosis have inadequate respiratory function. At the same time, these children show muscle weakness in certain parts of the body.

The aim of this study is to compare young adolescents with scoliosis with their healthy peers and examine whether respiratory muscle strength, peripheral muscle strength and postural control are affected.


Eligibility criteria: Inclusion Criteria:

* Individuals agreeing to participate in the study
* In the age range of 10-20
* Patients with scoliosis with a Cobb angle of 15-40 degrees measured on X-Ray

Exclusion Criteria:

* Surgical operation in the last 3 months
* Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises.

Primary outcomes:
measure: Respiratory Muscle Strength
timeFrame: Baseline
measure: Peripheral Muscle Strength
timeFrame: Baseline
measure: Postural Control
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
state: Eyüp
Study officials:
References:
Clinical trial NCT01777425: Long-term Control in Rhinosinusitis After Functional Endoscopic Sinus Surgery (FESS)
Official title: Long-term Control in Rhinosinusitis After FESS: Cross-sectional Observational Study on Control in Rhinosinusitis at a Mean Interval of 3 Years After FESS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Condition of Patient 3 Years After FESS-operation
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 389
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: rhinosinusitis patients

Brief summary: State-of-the-art documents like ARIA and european position paper on rhinosinusitis (EPOS) provide clinicians with evidence-based treatment algorithms for allergic rhinitis (AR) and chronic rhinosinusitis (CRS) respectively (1)(2) . The currently available medications can alleviate symptoms associated with AR and RS, and most patients with RS benefit from endoscopic sinus surgery (ESS). In real life, a significant percentage of patients with AR and CRS continue to experience bothersome symptoms despite adequate treatment. This group with so-called severe chronic upper airway disease (SCUAD) represents a therapeutic challenge (3).


Eligibility criteria: Inclusion Criteria:

1. Patients that have undergone bilateral ESS for inflammatory sinonasal disease, without additional sino-nasal surgery after the ESS.
2. Age \> 18 and \< 75 years.
3. Written informed consent
4. Dutch, French or English speaking patients

Exclusion Criteria:

1. Unilateral ESS
2. Benign and malignant tumor disease
3. Patient with a psychiatric, addictive, or any disorder of which the investigators feel at the time of evaluation for participation in the study that this may compromise the ability to give truly informed consent for participation in this study or provide reliable information on the questionnaire
4. Lack of knowledge of Dutch, French or English

Primary outcomes:
measure: Control Status of Patients With Rhinosinusitis
timeFrame: 3 years after FESS
Secondary outcomes:
measure: Control Nasal Endoscopy
timeFrame: 3 years after ESS
Other outcomes:
measure: Visual Analogue Scale (VAS), Sinonasal Outcome Test (SNOT22) and Short Form (36) Health Survey (SF36) Score Three Years After ESS in Controlled, Partially Controlled and Uncontrolled Group
timeFrame: three years after ESS
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven ORL
state: Vlaams Brabant
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Peter Hellings, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01933425: Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade
Official title: Optimizing Surgical Conditions: Intraabdominal Distance During Gynecologic Laparoscopic Surgery With and Without Muscle Relaxation (The Measurement Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Keywords: surgical conditions
laparoscopy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2013-09-02
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg.

Hypothesis:

Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.


Eligibility criteria: Inclusion Criteria:

* patients \> 18 years old
* elective laparoscopic operation
* can read and understand Danish
* informed consent

Exclusion Criteria:

* BMI \> 30 kg/cm2
* known allergy to medications that are included in the project,
* severe renal disease, defined by S-creatinine\> 0,200 mmol/L, GFR \< 30ml/min or hemodialysis),
* neuromuscular disease that may interfere with neuromuscular data,
* lactating or pregnant,
* impaired liver function,
* converting to laparotomy,
* perioperative use of neuromuscular blocking agents before randomization,
* pneumoperitoneum set to \>12 mmHg on the insufflator

Primary outcomes:
measure: Intraabdominal Distance (Centimeters)
timeFrame: 1 hour
Secondary outcomes:
measure: Intraabdominal Distance (Centimeters)
timeFrame: 1 hour
measure: Surgical Conditions During Suturing of the Abdominal Fascia
timeFrame: 1 hour
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of minimal invasive gynecology Aleris-Hamlet Private Hospital
state: Søborg
Study officials:
affiliation: Department of Anesthesiology Herlev Hospital
name: Matias Vested Madsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of minimal invasive gynecology, Aleris-Hamlet, Copenhagen
name: Olav Istre, MD, DMSc, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06688825: Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program
Official title: Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Transplant; Complications
Obesity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: American Society of Health-System Pharmacists Research and Education Foundation
First posted: 2024-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) patient education using a proven weight loss curriculum, and (2) technology tools for making healthy lifestyle choices.
Primary purpose: TREATMENT

Brief summary: This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) patient education using a proven weight loss curriculum, and (2) technology tools for making healthy lifestyle choices.

Detailed description: To optimize care for overweight/obese patients who are awaiting kidney transplants by implementing a referral process and a multi-pronged, team-based nurse/pharmacist/dietitian weight loss treatment intervention to help these patients achieve transplant criteria. Obesity, hypertension, and ESRD disproportionately affect the Black community, and Black patients have been historically disadvantaged by race-inclusive calculations that overestimated their kidney function. Effective January 5, 2023, the Organ Procurement and Transplantation Network Board of Directors requires use of a race-neutral estimated glomerular filtration rate (eGFR) to qualify candidates for kidney transplant. They also required transplant programs to identify Black candidates who may have been wrongly denied qualification

Eligibility criteria: Inclusion Criteria:

* on the waiting list for kidney transplant at VCUHS
* BMI greater than 35 kg/m2

Exclusion Criteria:

* Children, prisoners, pregnant women

Primary outcomes:
measure: Quality of Life-Lite survey
timeFrame: Only completed at baseline and week 40
measure: Meal recall survey
timeFrame: completed at weeks 1, 4, 8, 12, 20 and 28
measure: PrevenT2 education T
timeFrame: Weekly for weeks 1-12, then monthly on weeks 16, 24, 28, 32 and 36
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Evan Sisson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00808925: The Impact of Heat Acclimation on Pro- and Anti- Inflammatory Cytokine Response
Official title: The Impact of Heat Acclimation on Pro- and Anti- Inflammatory Cytokine Response
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: "Exposure to Heat"
Keywords: acclimation
heat
cytokines
stress
inflammation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Medical Corps, Israel Defense Force
First posted: 2008-12-16
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: There is growing evidence to conclude that part of the cascade leading to heatstroke is related to an inflammatory reaction triggered by the heat stress. The reduced ability to sustain heat stress - "heat intolerance" is also attributed to over-expression of inflammatory cytokines. Acclimation to heat improves human sustainability to heat and is a leading protective factor against heat stroke. The investigators hypothesize that the lower stress encountered during the process of acclimation to heat will be reflected by an over-ride in the expression of anti-inflammatory over the pro-inflammatory cytokines. This, in turn will attenuate the pathological cascade leading to heat stroke.


Eligibility criteria: Inclusion Criteria:

* age:18-25
* medically screened (healthy)

Exclusion Criteria:

* BMI over 22 kg/m2
* systolic blood pressure over 120 mmHg
* any febrile illness during the last week preceding the study
* any skin disease
* diabetes
* any heart conditions.

Primary outcomes:
measure: Investigating the variability in the levels of different cytokine and the kinetics in cytokine levels during the process of acclimation to heat.
timeFrame: 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Heller Institute of Medical Reachearch, Sheba Medical Center
Study officials:
affiliation: Institute of Military Physiology, IDF Medical Corps
name: Daniel S Moran, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04941222: Cost-utility Analysis of the Use of the Paro Robotic Seal by Elderly Patients With Moderate or Severe Cognitive Disorders in Institutions: a Randomised Study.
Official title: Cost-utility Analysis of the Use of the Paro Robotic Seal by Elderly Patients With Moderate or Severe Cognitive Disorders in Institutions: a Randomised Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cognitive Impairment
Keywords: PARO
non-pharmacological intervention
economic evaluation
Cognitive Impairment
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 33
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Many residents from establishments for dependent elderly people (EHPAD) have memory disorders with behavioural problems such as agitation, aggression and anxiety, which make it difficult to assist them on a daily basis.

Studies have proven the beneficial effect of the therapeutic seal robot PARO® in behavioural disorders. The present project aims to complement these data with a medico-economic study. At present, the only study of this type has been carried out in Australia, and is not transposable to France.


Eligibility criteria: Inclusion Criteria:

* Patients over 70 years of age
* With moderate or severe neurocognitive disorders of any etiology (Mini Mental State Examination (MMSE) less than or equal to 20, or not feasible)
* Resident in EHPAD (establishment for dependent elderly people) or USLD (long-term care unit ) in permanent accommodation for more than 1 month at inclusion

Exclusion Criteria:

* Patient with presumed life expectancy of less than 3 months
* Mini Mental State Examination (MMSE) not feasible for any reason other than cognitive impairment (e.g. stroke aphasia), without dementia
* Known carrier of multi-drug resistant bacteria
* Carrier of Pace-maker (precautionary advice from manufacturer)
* Refusal to participate to the study (trusted person, guardian or curator or patient depending on the patient's mental state)
* Patient under court protection
* Prior inclusion in an interventional study that may alter the interpretation of the results of the analysis
* Patient not affiliated to a social security system or beneficiary of such a system

Primary outcomes:
measure: Incremental cost-utility ratio
timeFrame: 16 weeks after implementation of toilets with/without PARO
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: CHD Vendee
Study officials:
affiliation: CHD Vendée
name: stéphanie CHENEAU
role: PRINCIPAL_INVESTIGATOR
References: