louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05600348: Dose-dependent Identification of Unique Biomarkers
Official title: Personalized Pork: Dose-dependent Identification of Unique Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Metabolome
Pork
Metabolite
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 3 conditions, order randomly allocated
Primary purpose: SCREENING

Brief summary: The purpose of the research is to assess the dose-dependent impacts of the consumption of fresh pork on blood-borne metabolites (markers) following the controlled feeding of pork

Detailed description: Eligible participants will follow 3 randomly ordered 4-week feeding periods varying only with the consumption of 0, 3 or 6 oz of pork or a 50:50 blend of chicken and beef (6, 3 and 0 oz for respective trials to ensure similar total poultry/meat intake among trials).

Eligibility criteria: Inclusion Criteria:

* generally healthy (i.e., an absence of diagnosed chronic illnesses and inborn metabolic disorders)
* Age 18-65
* all races
* both sexes
* willingness to comply with the research diet requirements

Exclusion Criteria:

* special dietary needs (e.g., vegetarianism, gluten-free, etc.)
* use of medication known to influence metabolism
* smoking
* substance use

Primary outcomes:
measure: Metabolic biomarker discovery
timeFrame: 4 weeks
Secondary outcomes:
measure: Fasted Glucose
timeFrame: 4 weeks
measure: Insulin
timeFrame: 4 weeks
measure: HDL Cholesterol
timeFrame: 4 weeks
measure: Total Cholesterol
timeFrame: 4 weeks
measure: LDL-Cholesterol
timeFrame: 4 weeks
measure: Triglycerides
timeFrame: 4 weeks
measure: Interleukin-6
timeFrame: 4 weeks
measure: C-Reactive Protein
timeFrame: 4 weeks
measure: Blood Pressure
timeFrame: 4 weeks
measure: Body Composition
timeFrame: 4 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: School of Exercise and Nutritional Sciences
state: California
Study officials:
affiliation: San Diego State University
name: Shirin Hooshmand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01082848: ARIpiprazole in Anorexia NErvosa
Official title: Efficacy of Aripiprazole in the Treatment of Anorexia Nervosa in Teenagers: a Pilot, Randomised, Double Blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anorexia Nervosa
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2010-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evidence is lacking on the effects of different psychotropic drugs in the treatment of anorexia nervosa (AR). However, HVA levels seem to be elevated in this disease, therefore suggesting a role for drugs with a partial agonist profile on dopaminergic receptors. This is a pilot study assessing the effects of aripiprazole in teenagers with AR, compared with a placebo.


Eligibility criteria: Inclusion Criteria:

* age between 12 and 18
* diagnostic criteria for anorexia Nervosa (DSM-IV-TR (includes BMI below 17.5kg/m2 and above 14 kg/m2) confirmed by a Psychiatrist and validated by K-SADS-PL interview
* severity criteria requiring Hospital admission
* Consent given by parents and patients

Exclusion Criteria:

* psychotic illness
* antipsychotic therapy at inclusion
* pregnancy and breastfeeding
* antipsychotic drug allergy
* prior head trauma, malignant neuroleptic syndrome or epilepsy
* relevant comorbidities requiring therapy
* detection of abuse drugs in urine test
* treatment with neuroleptic, antidepressant or mood stabilizers during 2 weeks prior to randomization (4 weeks in case of fluoxetine)
* suicidal or homicidal thoughts
* IQ below 70

Primary outcomes:
measure: Eating Disorder Inventory-2
timeFrame: 6 months
measure: Eating attitudes test (EAT)
timeFrame: 6 months
measure: Brown Assessment of Beliefs Scale (BABS)
timeFrame: 6 months
Secondary outcomes:
measure: BMI
timeFrame: 6 months
measure: BDI
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Catalonia
Study officials:
References:
Clinical trial NCT06264648: Investigation of Palpation Pressure Sensitivity
Official title: Investigation of Palpation Pressure Sensitivity of Physiotherapists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensitivity Training Groups
Keywords: Palpation
Manual therapy
Pressure
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 63
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups of physiotherapists with different fields of experience were attended to study.
Primary purpose: OTHER

Brief summary: The study is planned for searching physiotherapists palpation abilities. There were 2 groups of physiotherapists. They were asked for to push target pressures. After making some exercise, the assesment was done again.

Detailed description: 2 groups of physiotherapists with different fields of experience were attended to study. Fingers are positioned on the marked area at the center point of the scale. Therapists were asked to apply pressure to the scale with estimated weights of 0.5 kg, 1 kg, 2 kg and 4 kg. In each measurements, the value on the scale was recorded without being shown to the participants. After the measurements, the participants were made to experiment when the digital screen can be seen, in order to teach the physiotherapists how much pressure they applied to reach the target weight. Participants were given a total of 10 minutes for the trials. Then, the digital screen was hidden again, and the therapist was asked to apply 0.5 kg, 1 kg, 2 kg and 4 kg weight in a randomized order and maintain that pressure for 5 seconds. The weight fixed by the therapist for 5 seconds was noted by the researcher; the participant was not informed about the values on the digital screen.

Eligibility criteria: Inclusion Criteria:

* Willing to participate,
* Active working patients as a physiotherapists pediatric, neurologic, orthopedic physiotherapy, manual therapy or osteopathy.

Exclusion Criteria:

* Having a neurological disease (multiple sclerosis, polyneuropathy, etc.) -Having a disease that may cause neurological deficit in the upper extremity (cervical myelopathy, carpal tunnel syndrome, pronator teres syndrome, cubital tunnel syndrome, ---
* Guyon canal syndrome)
* Refuse to participate

Primary outcomes:
measure: Measurement Palpation Pressure with Digital Scale
timeFrame: baseline
measure: Measurement Palpation Pressure with Digital Scale
timeFrame: 10 minute after pressure sensitivity education
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Faculty of Health Sciences Bolu Abant İzzet Baysal University
Study officials:
affiliation: Abant Izzet Baysal University
name: Ömer Osman Pala, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01359748: Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO
Official title: Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: Non Invasive Blood Pressure measurement study.
Lead sponsor: Aguiflai Iberica, S.L.
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this trial is to determine the accuracy of the Blood Pressure (BP) measurement of multifunction KEITO devices under test requirements of the Standard American National Standards Institute(ANSI)/Association for the Advancement of Medical Instrumentation(AAMI)/International Organization for Standardization (ISO): ANSI/AAMI/ISO 81060-2:2009.

Detailed description: Nowadays is important controlling our basic health parameters. Due this, the multifunction KEITO Devices was designed to offer to the general public a convenient way to do so easily in the public sites.

One of the most important parameter is the Blood Pressure (BP)measurement. To warrant their efficacity and accuracy, was essential to perform this trial to ensure that the measurements obtained meet with the requirements of the specific U.S. standard about Non-invasive sphygmomanometers.

By Validating with auscultatory reference sphygmomanometer, as defined on the ANSI/AAMI/ISO 81060-2:2009 , we have been intending to demonstrate that the multifunction KEITO devices, particularly about the Blood Pressure (BP) Measurement, have the same efficacy and accuracy as the conventional auscultatory sphygmomanometers.

To include most of the groups of Blood Pressure (BP) measurements types on this clinical trial, a great variety of BP ranges have been selected, always in accordance with the standard.

Eligibility criteria: Inclusion Criteria:

* Wrist circumference: 12 to 20 Cm
* At least 5% of the readings shall have Systolic BP\<=100 mmHg
* At least 5% of the readings shall have Systolic BP\>=160 mmHg
* At least 20% of the readings shall have Systolic BP\>=140 mmHg
* At least 5% of the readings shall have Diastolic BP\<=60 mmHg
* At least 5% of the readings shall have Diastolic BP\>=100 mmHg
* At least 20% of the readings shall have Diastolic BP\>=85 mmHg

Exclusion Criteria:

* Pregnant Women

Primary outcomes:
measure: BP Measurements Using the Reference Auscultatory Sphygmomanometer
timeFrame: Five minutes
measure: BP Measurement Using Multifunction KEITO
timeFrame: 30 seconds
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Angel P Ferre, Engineer
role: STUDY_DIRECTOR
name: Francisco B Contreras, Technician
role: STUDY_CHAIR
References:
Clinical trial NCT02485548: Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent With Radiotherapy for Head and Neck Squamous Cell Cancer
Official title: A Multicenter Phase Ⅲ Trial of Cisplatin Plus Raltitrexed or 5-fluorouracil in Concurrence With Intensity-modulated Radiotherapy (IMRT) for the Treatment of Locoregionally Advanced Head and Neck Squamous Cell Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Head and Neck Squamous Cell Cancer
Lead sponsor: Jiangsu Cancer Institute & Hospital
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Jiangnan University
name: Changzhou Cancer Hospital of Soochow University
name: The First Affiliated Hospital with Nanjing Medical University
name: Northern Jiangsu People's Hospital
name: The Second Hospital of Nanjing Medical University
name: Nanjing BenQ Hospital
First posted: 2015-06-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.

Detailed description: The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed untreated head and neck squamous cell cancer patients
* 18-70 years
* Clinical stage: T3-4N0-3M0 or T1-4N1-3M0
* Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
* Renal function: Cr ≤ 1.25×UNL
* Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
* ECOG ≤ 1
* Woman and man of childbearing age must adopt contraception
* With written consent

Exclusion Criteria:

* Malignant history
* Pregnant or lactating women
* With other severe diseases (blood, liver ,kidney or heart diseases)
* Subjects not suitable for chemo-radiotherapy
* Without written consent

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 36 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 36 months
measure: Locoregional and distant control rate
timeFrame: 36 months
measure: Percentage of participants experiencing grade 3-5 adverse events(AEs)
timeFrame: 36 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
Study officials:
affiliation: Jiangsu Cancer Institute & Hospital
name: Xia He, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04715048: Split-Face Study Comparing Botox and Jeuveau in Treating Glabellar Lines
Official title: Split-Face Study Comparing OnabotulinumtoxinA (Botox) and PrabotulinumtoxinA (Jeuveau) in Treating Glabellar Lines
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Glabellar Frown Lines
Keywords: Botox, Jeuveau
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and side effects of Botox and Jeuveau for glabellar lines.

Detailed description: After being informed about the study and potential risks, all patients given consent will receive Botox on one side of their face and Jueveau on the other. A random number generator will generate a list of 20 combinations of "1,2" or "2,1". "1,2" means the Botox (onabotulinumtoxin A) will be placed on the right side and "2,1" means that the Botox will be placed on the left. The other side will be injected with PrabotulinumtoxinA. 8-10 units will be injected into the designated glabella in 3 sites.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Willingness to participate in the study and able to provide informed consent

Exclusion Criteria:

* Inability to follow up for study duration
* Prior neurotoxin injection in the last 4 months
* Prior surgery to the glabellar area
* Any planned aesthetic procedure to the glabellar area during the study period
* Cardiac Patients

Primary outcomes:
measure: Movement on a 10 point Frown Movement Scale at 3 weeks
timeFrame: 3 weeks
Secondary outcomes:
measure: Days to onset of neurotoxin
timeFrame: Up to 2-4 days
measure: Bruising from the injection on a scale of 1-10
timeFrame: Up to 2-4 days
measure: Pain from the injection on a scale of 1-10
timeFrame: Up to 2-4 days
measure: Headache from the injection on a scale of 1-10
timeFrame: Up to 2-4 days
measure: Movement on a 10 point Frown Movement Scale at 3 weeks
timeFrame: 3 weeks
measure: Change in glabellar lines on the Merz Score (0-4)
timeFrame: At baseline and 3 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Roski Eye Institute
state: California
Study officials:
References:
citation: Rzany BJ, Ascher B, Avelar RL, Bergdahl J, Bertucci V, Bodokh I, Carruthers JA, Cartier H, Delmar H, Denfeld R, Gross JE, Heckmann M, Heden P, Hilton S, Inglefield C, Ogilvie P, Sattler G, Sebastian M, Solish N, Swift A, Trevidic P. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients. Aesthet Surg J. 2020 Mar 23;40(4):413-429. doi: 10.1093/asj/sjz110.
Clinical trial NCT06089148: New Mammographic Techniques Versus MRI in Assessment of Breast Lesions
Official title: Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: FEMALE

Brief summary: Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast lesions

Detailed description: Combined use of contrast-enhanced digital mammography (CEDM), and digital breast tomosynthesis (DBT), may be a reasonable alternative to MRI.

Eligibility criteria: Inclusion criteria

1. Breast Imaging Reporting and Data System (BI-RADS) 3, 4, and 5 breast lesions.
2. Clinical indication for MRI breast imaging.
3. No histologically proven cancer before enrollment. Exclusion criteria

1. Pregnancy or possible pregnancy. 2. History of allergy to an iodinated contrast agent. 3. Renal impairment. 4. Contraindication for MRI examination

Primary outcomes:
measure: sensitivity, specificity of'tomosynthesis and contrast enhanced mammography and MRI breast are measured in assessment of breast lesions and their pre-operative assessment of breast cancer
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01588548: Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
Official title: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients With Advanced Solid Malignancies Including Malignant Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Malignancies
Malignant Lymphoma
Keywords: Advanced solid malignancies
Malignant lymphoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-05-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid malignancies including malignant lymphoma

Detailed description: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients with Advanced Solid Malignancies including Malignant Lymphoma

Eligibility criteria: Inclusion Criteria:

* Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study
* Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for which no standard therapies exist
* Patients with good physical conditions (you can walk and can look after yourself) within the last 2 weeks.
* Patients who have at least one lesion that can be accurately assessed

Exclusion Criteria:

* Patients who have recently received or are receiving prohibited medications or treatments
* Patients who have any unresolved side effects of previous treatments
* Patients who have spinal cord compression or brain metastases
* Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis B, hepatitis C and human immunodeficiency virus \[HIV\] infection)
* Patients with significant abnormal ECG findings

Primary outcomes:
measure: Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
timeFrame: Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1
Secondary outcomes:
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Surrey
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AZ
name: Frank Neumann, MSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01522157: A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes
Official title: A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diet
Low-carbohydrate
Postprandial
Type 2 diabetes mellitus
Lead sponsor: Vårdcentralen Lyckorna
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The trial will study the acute metabolic effects of three different types of diet: low-fat diet, low-carbohydrate diet and Mediterranean diet. About 20 patients with diabetes mellitus type 2 will be recruited and each of them will be given each type of diet on three different days. Menus with the same energy content but with different content of fat, carbohydrate and protein are designed. Breakfast and lunch are served for the patients each day of testing. Laboratory samplings are performed six times during the day. The order of the dietary intervention is randomized for each patient.

The investigators suppose to find different reaction in plasma glucose and lipids depending on the type of diet.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus type 2

Exclusion Criteria:

* Treatment with insulin or sulfonylurea

Primary outcomes:
measure: P-glucose
timeFrame: 6 months
measure: P-Triglycerides
timeFrame: 6 months
Secondary outcomes:
measure: P-Cholesterol
timeFrame: 6 months
measure: P-LDL-Cholesterol
timeFrame: 6 months
measure: P-HDL-Cholesterol
timeFrame: 6 months
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Medical and Health Sciences, Linköping University
Study officials:
affiliation: Department of Endocrinology Linköping University Hospital
name: Fredrik H Nystrom, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernemark H, Jaredsson C, Bunjaku B, Rosenqvist U, Nystrom FH, Guldbrand H. A randomized cross-over trial of the postprandial effects of three different diets in patients with type 2 diabetes. PLoS One. 2013 Nov 27;8(11):e79324. doi: 10.1371/journal.pone.0079324. eCollection 2013.