louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02708485: Effect of Walking on Brain Fuel Consumption in Mild Alzheimer's Disease
Official title: Evaluating the Impact of Physical Exercise on Mild Alzheimer's Disease in a Randomized Clinical Trial: Quantification With 18F -FDG and 11C- AcAc PET Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of a 3-month walking program on brain energy metabolism in patient with mild Alzheimer's disease (AD). Two groups of sedentary patients with mild AD are followed and compared over a 3-month period of time: Control (non-active) and walking (from 15 to 45 minutes of exercise on a treadmill, 3 times a week for 12 weeks) groups. All the participants are evaluated on their cognition, brain volumes (MRI) and brain fuel consumption (PET scan with 18-FDG and 11C-AcAc) at the beginning and at the end of the study.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild Alzheimer's disease (NINCDS-ADRDA criteria)
* Taking cholinesterase inhibitors
* Sedentary
* Ability to do physical exercise

Exclusion Criteria:

* Parkinson disease
* Down syndrome
* Epilepsy or concussion
* Drug or alcohol abuse
* Past psychiatric history
* Vitamin B12 Deficiency
* Uncontrolled diabetes or thyroid function

Primary outcomes:
measure: Brain Glucose Consumption
timeFrame: 3 months
measure: Brain Acetoacetate Consumption
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
state: Quebec
Study officials:
affiliation: Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
name: Nancy Paquet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CDRV - CSSS-IUGS - CIUSSS de l'Estrie - CHUS
name: Stephen Cunnane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02097485: Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
Official title: A Randomised, Double-Blind, Vehicle-Controlled Study of Ovicidal Efficacy and Safety of Abametapir 0.74% Administered 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: 2014-03-27
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to evaluate ovicidal efficacy of a single application of abametapir lotion 0.74% w/w intended for the treatment of head lice.

Detailed description: This was a double-blind, randomised, vehicle-controlled, parallel group study in males and females, aged three years and older with active head lice infestation. The study was designed to assess the ovicidal efficacy of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at the study site. This study used an ex vivo method of assessment for ovicidal efficacy.

Eligibility criteria: Inclusion Criteria:

1. Healthy male or female based on medical history
2. Six months of age or older.
3. Has an active head lice infestation with a minimum of 3 live head lice and at least 10 undamaged and unhatched head lice eggs in their hair.
4. Agrees to an examination for head lice and compliance with the study procedures.
5. All adult subjects must sign a written voluntary informed consent. For minors, the parent/ legal guardian agrees to the subject participating in the study as determined by the signing of an assent of informed consent.

Exclusion Criteria:

1. Has scalp disease or a history of allergies or prior reactions to any head lice products.
2. Has a condition that, in the opinion of the Investigator, may interfere with the study.
3. Is receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
4. Had treatment (over-the-counter (OTC) or home remedy medication) for head lice within 14 days prior to Day 0.
5. Has received an investigational agent within 30 days prior to Day 0.

Primary outcomes:
measure: Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ringwood East
country: Australia
facility: National Head Lice Treatment Centre
state: Victoria
Study officials:
affiliation: National Head Lice Treatment Centre, Ringwood East, Victoria, Australia, 3135
name: Scott Arnold, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05795985: Role of Faecal Calprotectin in Patients With Abdominal Pain
Official title: Role of Faecal Calprotectin in Patients Presenting to the Emergency Department With Abdominal Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with abdominal pain and/or diarrhea and/or rectal bleeding accessing the emergency department

Brief summary: The evaluation of patients with abdominal pain is a challenge for the emergency physician and the selection of patients for second-level radiological examinations or endoscopic procedures is not always easy to perform. Faecal calprotectin could be a useful diagnostic marker to distinguish between "organic" or "functional" form and its determination could be helpful to select patients for further examinations, in the context of emergency setting.


Eligibility criteria: Inclusion Criteria:

* patients with abdominal pain and/or diarrhea and/or rectal bleeding

Exclusion Criteria:

* patients with age \< 18 years
* pregnant women;
* patients with oncological, cardiological, nephrological terminal diseases;
* patients on antibiotic therapy or who have taken it during the last month;
* patients with a history of colic resection or gastrointestinal surgery;
* patients with a previous diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis)

Primary outcomes:
measure: inflammation
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
References:
Clinical trial NCT05561985: Expanded Access Use of Itacitinib to Treat a Single Patient With STAT1 Gain of Function (GOF) Disease
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: STAT1 Gain-of-Function Disease
Keywords: STAT1 GOF disease
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-09-30
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access use of Itacitinib to treat a single patient with aplastic anemia.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baylor College of Medicine - Texas Children's Hospital
name: Lisa Forbes Satter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02457585: Clinical Study of Anti-tumor Necrosis Factor Therapy in Patients With Takayasu Arteritis
Official title: Anti-tumor Necrosis Factor Therapy Effect on Takayasu Arteritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Takayasu's Arteritis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical study of anti-tumor necrosis factor therapy in patients with Takayasu arteritis.

This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled patients will be 11

Detailed description: Clinical study of anti-tumor necrosis factor therapy in patients with Takayasu arteritis.

This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled patients will be 11 patients with active takayasu's arteritis

Eligibility criteria: Inclusion Criteria:

* active takayasu's arteritis

Exclusion Criteria:

* active Tuberculosis
* Liver function abnormality
* heart failure ( New York Heart Association III - IV)
* patients were not consented

Primary outcomes:
measure: remission induction at 30 weeks
timeFrame: 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yeong Wook Song, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park EH, Lee EY, Lee YJ, Ha YJ, Yoo WH, Choi BY, Paeng JC, Suh HY, Song YW. Infliximab biosimilar CT-P13 therapy in patients with Takayasu arteritis with low dose of glucocorticoids: a prospective single-arm study. Rheumatol Int. 2018 Dec;38(12):2233-2242. doi: 10.1007/s00296-018-4159-1. Epub 2018 Sep 18.
Clinical trial NCT03238885: Predicting Pathological Complete Response of Rectal Cancer With Magnetic Resonance(MR) Radiomics
Official title: Predicting Pathological Complete Response of Rectal Cancer to Neoadjuvant Chemoradiotherapy With MR Radiomics Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced Rectal Cancer
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 538
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: LARC patients who will undergo neoadiuvant CRT before surgery.

Brief summary: This study plans to construct a MR radiomics model for predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC) patients.

Detailed description: We propose to develop and validate a radiomics model for individualized pCR evaluation after CRT in patients with LARC. We plan to use both pre- and post-CRT MRI data to construct the predictive radiomics model for evaluating if LARC patients achieve pCR after CRT. The ultimate aim is to select appropriate LARC patients for omission of surgery.

Eligibility criteria: Inclusion Criteria:

* pathologically proved rectal cancer
* locally advanced rectal cancer (≥T3 or N+)
* a distance less than 12cm between the lower edge of tumor and the anal margin
* no evidence of distant metastases
* no prior anti-cancer therapy before treatment
* scheduled to receive preoperative CRT

Exclusion Criteria:

* history or concurrent of other malignancy
* incomplete preoperative CRT
* failed to receive surgery or unavailable pCR assessment
* poor quality of MR images for measurement
* patient quit

Primary outcomes:
measure: Pathological complete response(pCR)
timeFrame: within one week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Ying-Shi Sun
role: STUDY_CHAIR
References:
Clinical trial NCT03907085: The Effect of High Intensity Laser Therapy in the Management of Painful Calcaneal Spur
Official title: The Effect of High Intensity Laser Therapy in the Management of Painful Calcaneal Spur: a Double Blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcaneal Spur
Keywords: HILT
calcaneal spur
placebo
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The effect of high intensity laser therapy in the management of painful calcaneal spur: a double blind, placebo-controlled study

Detailed description: The objective of this study was to evaluate the effect of high-intensity laser therapy (HILT) and exercise in patients with calcaneal spur. The patients were randomly assigned to receive either HILT + exercise (n=21) or placebo HILT + exercise (n=21). Pain severity (with visual analog scale (VAS) and with Roles and Maudsley score (RMS) ), functionality (with Foot and Ankle Outcome Score (FAOS)), plantar pressure measurement (with pedobarographic assesment), and quality of life (with short form-36 (SF-36)) of the patients were evaluated at baseline, at 4 weeks, and 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Eligible patients aged 30-75 years old with pain in the plantar region lasting for at least one month, who were sensitive to palpation and who were diagnosed with a calcaneal spur in the subcalcaneal region as shown in a lateral x-ray of the foot were included in the study.

Exclusion Criteria:

* Patients with any sign of pathology in the blood count, with an increased sedimentation rate, having undergone any physical therapy for calcaneal spur within the past six months and/or local anesthesia and/or steroid injection in the region of pain, with the presence of a pathology on the x-ray apart from calcaneal spur, pregnancy, with the presence of systemic inflammatory disease, and with a history of local trauma or a history previous HILT therapy were excluded from the study

Primary outcomes:
measure: Change from baseline visual analog scale (VAS) at 4th and 12th week.
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks.
timeFrame: Up to12 weeks
measure: Change from baseline Foot and Ankle Outcome Score (FAOS) at 4th and 12th weeks
timeFrame: Up to12 weeks
measure: Change from baseline Roles and Maudsley Pain Score at 4th and 12th weeks.
timeFrame: up to 12 weeks
measure: Change from baseline static and dynamic pedobarographic evaluations at 4th and 12th weeks.
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Afyon
country: Turkey
facility: Hilal Yesil
state: Eyalet/Yerleşke
Study officials:
References:
Clinical trial NCT02926885: Efficacy Evaluation of the Esophagogastric Junction Exposure Obtained by the Flexible Liver Retractor in Gastroplasty
Official title: Efficacy Evaluation of the Esophagogastric Junction Exposure Obtained by the Flexible Liver Retractor in Gastroplasty for Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: liver
laparoscopy
Bariatric Surgery
Esophagogastric Junction
obesity
Lead sponsor: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Evaluation of a new technique of liver retraction for the exposure of the His angle in gastric bypass Roux-en-Y surgery.

Detailed description: Obesity is a chronic disease of clinical treatment initially, but with precise surgical indications regulated by national and international health organizations. Among the surgical techniques, the gastric bypass Roux-en-Y is considered the "gold standard" for its efficiency and low morbidity and mortality. In gastric laparoscopic surgery it is necessary to move the liver in order to ensure adequate working space and a good view. Conventional laparoscopic retractors surgery are generally coarse, require an additional incision for its installation, or handling by an assistant during surgery and involve risk of liver injury. The objective of this study was to evaluate the efficacy of a flexible liver retractor in the exposure of the His angle in Roux-en-Y gastric bypass for morbid obesity. This was a prospective, controlled, open and comparative study, with 100 patients randomly divided into two groups (conventional and flexible retractor), with medical indication for bariatric surgery. Data were recorded during surgery in both groups for comparison of the two hepatic retraction techniques.

Eligibility criteria: Inclusion Criteria:

* Between 18 - 65 years, both genders, with indication of bariatric surgery according to IFSO criteria.
* Agreed to participate and signed informed consent form.

Exclusion Criteria:

* Patients who did not agree to participate and / or any other condition that the investigator judged relevant for not participating in the study were excluded.

Primary outcomes:
measure: Number of incisions made during laparoscopic surgery using flexible retractor when compared to conventional retractor
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Nucleo de Pesquisa e Desenvolvimento da Universidade Federal do Ceara
state: CE
Study officials:
affiliation: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
name: Rodrigo Babadopulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00476385: Practicability and Acceptability of Stylomax® in Children
Official title: Usability and Acceptability of Stylomax® in Growth Hormone Deficient Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Deficiency
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-05-22
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective:

to evaluate the practicability and acceptability of STYLOMAX®, a new injection device for MAXOMAT®, in children, for 1 year.


Eligibility criteria: Inclusion Criteria:

* Children over 3 years of age with growth hormone deficiency, requiring treatment with MAXOMAT® according to the criteria of the MA.

Exclusion Criteria:

* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: practicability/acceptability of the Stylomax pen
timeFrame: at each visit
Secondary outcomes:
measure: tolerability : pain (evaluation on pain scale)
timeFrame: at each visit
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Marie SEBILLE, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT03860285: Objective and Perceived Quality Study in Patients Undergoing Elective Groin Hernia Surgery
Official title: Objective and Perceived Quality Study in Patients Undergoing Elective Groin Hernia Surgery by the Abdominal Wall Surgery Unit of the Hospital Complex of Navarra
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Inguinal Hernia
Quality of Life
Surgery
Survey
Keywords: inguinal hernia
quality of life
survey
surgery
pamplona
prospective
observational
cohorts
Lead sponsor: Hospital of Navarra
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 850
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective inguinal hernia surgery en Pamplona

Brief summary: This is a prospective non-comparative observational study of cohorts. Consists on offering surveys to every patient undergoing groin hernia surgery in our Abdominal Wall Surgery Unit, in Hospital of Navarra.

Detailed description: HYPOTHESIS:

The objective and perceived quality data of the patients under study (adult patients undergoing scheduled inguinal hernia without complications) in Pamplona are within the international quality standards.

OBJECTIVES

Primary objective:

-Obtaining data of objective and perceived quality of patients undergoing elective groin hernia surgery in Pamplona durinag a year to compare them with international quality standards.

Secondary objectives:

* Obtaining data on duration of sick leave (temporary disability due to common contingency) associated with the referred procedures, as well as their possible complications.
* Assess the costs associated with the intervention and its possible complications.
* Raise options (if necessary and feasible) to improve the results exposed obtained by our service.

Eligibility criteria: Inclusion Criteria:

* Patients entering surgical waiting list during a year (from March 1st, 2018, to February 28th, 2019).
* Elective surgery.

Exclusion Criteria:

* Age below 16.
* Mental diseases.
* Patients not capable of understanding the study.
* Patients that reject entering the study.

Primary outcomes:
measure: Obtaining objective and perceived quality of life
timeFrame: 4 years
Secondary outcomes:
measure: Knowing patients' pain
timeFrame: 4 years
measure: Registering hernia recurrence
timeFrame: 4 years
measure: Controlling presence or not of complications
timeFrame: 4 years
measure: Knowing patient satisfaction
timeFrame: 4 years
measure: Knowing duration of sick leave
timeFrame: 4 years
measure: Knowing waiting time for surgery
timeFrame: 4 years
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Hospital de navarra
state: Navarra
Study officials:
affiliation: Hospital de Navarra
name: Concepción Yárnoz-Irazabal, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05468385: The Effects of taVNS on Inhibitory Control
Official title: Transcutaneous Auricular Vagus Nerve Stimulation Improves Inhibitory Control in Emotional Go-Nogo Task
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of the study is to investigate whether the transcutaneous vagus nerve stimulation(tVNS) improves the ability of inhibitory control in an emotional Go-Nogo task.

Detailed description: A randomized, sham-controlled, between-subject design will be employed in this study. A total of 87 healthy subjects will receive either transcutaneous vagus nerve stimulation via tragus or sham stimulation via the earlobe in the left ear. Brain activity and behavioral data for an emotional Go-Nogo task will be recorded and saliva samples will be collected before, during, and after stimulation.

Some personal traits will be assessed using different kinds of questionnaires, such as the State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory(BDI), Autism Spectrum Quotient (ASQ) et al.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* pregnant, menstruating, taking oral contraceptives;
* medical or psychiatric illness.

Primary outcomes:
measure: The ability of inhibitory control in an emotional Go-Nogo task
timeFrame: After 30 minutes stimulation
measure: Oxytocin release
timeFrame: within 5 minutes after taVNS via tragus and earlobe
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China
state: Sichuan
Study officials:
References: