louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06383169: Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction
Official title: Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Investigate the Effect of External Lumbar Cistern Drainage in Preventing Postoperative Hydrocephalus in Patients Who Have Undergone Meningioma Surgery
Lead sponsor: First Hospital of Zhangjiakou City
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study analysed data from 86 patients who developed postoperative hydrocephalus following meningioma surgery, conducted between May 2019 and May 2022. Based on the inclusion and exclusion criteria, patients were divided into two groups. The control group (n = 43) received conventional treatment methods, and the observation group (n = 43) underwent external drainage of the lumbar cistern.

Brief summary: This study aims to investigate the effect of external lumbar cistern drainage in preventing postoperative hydrocephalus in patients who have undergone meningioma surgery and its impact on patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* diagnosis of meningiomas based on established diagnostic criteria and pathological confirmation
* postoperative development of hydrocephalus, specifically communicating hydrocephalus
* absence of other intracranial tumours or contraindications for surgery

Exclusion Criteria:

* concurrent mental disorders, coagulation dysfunction or organic diseases affecting other areas
* hematologic diseases, severe liver or kidney dysfunction
* patients discontinuing treatment or transferring to a higher-level hospital
* a history of hydrocephalus, such as obstructive hydrocephalus

Primary outcomes:
measure: Comparison of general clinical data
timeFrame: 2 weeks
measure: Comparison of the response rate
timeFrame: 2 weeks
measure: Comparison of GCS scores and intracranial pressure
timeFrame: 2 weeks
measure: Comparison of KPS scores and satisfaction
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zhangjiakou
country: China
facility: First Hospital of Zhangjiakou City
Study officials:
References:
Clinical trial NCT06036069: Effect of Whole Body Vibration Versus Core Stability Exercises on Balance and Muscle Strength in Children With Down Syndrome
Official title: Improvement of Whole Body Vibration and Core Stability Exercises on Muscle Strength in Down Syndrome Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Keywords: Children; Core Stability Exercises; Down Syndrome; Whole Body Vibration
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control study
Primary purpose: TREATMENT

Brief summary: Children had Down syndrome often have impaired balance and postural control and result as less active than their peers that can lead to reduced quality of life and movement skills. Effects of physical activity may be important in preventing falling risk and health consequences in those children

Detailed description: Sixty children from both genders (boys and girls) participated in this study, their ages ranged from 10 to 16 years and they were randomized into three groups of same number (A, B and C). Groups (A) received conventional physical therapy program, group (B) received the same conventional physical therapy program of group (A) and core stability exercises while group (C) received the same conventional physical therapy program of group (A and B) and whole body vibration exercise

Eligibility criteria: Inclusion Criteria:

* Aged between 10 to 16 years.
* Able to recognize commands given to them.
* Understand our verbal command and encouragement.
* Stand and walk independently without repeated falling.

Exclusion Criteria:

* Children with any neurological (signs of epilepsy and instability of atlantoaxial joint).
* Musculoskeletal, or mobility disorders.
* Cardiac anomalies.
* Vision or hearing loss.

Primary outcomes:
measure: Biodex Balance System
timeFrame: before intervention and after 12 weeks of intervention
Secondary outcomes:
measure: Hand-held dynamometer
timeFrame: before intervention and after 12 weeks of intervention
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ragaee Saeed Mahmoud
state: Faisal
Study officials:
References:
Clinical trial NCT00230269: The Role of FDG PET in Radiation Treatment Planning for Head and Neck Cancers
Official title: The Role of FDG PET in Radiation Treatment Planning for Head and Neck Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
First posted: 2005-09-30
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: Patients who are scheduled to receive radiation therapy for head and neck cancer at Stanford.

Brief summary: In patients with cancer of the head and neck and rectum, knowing the exact location of the tumor is important for designing the radiation field to ensure delivery of high dose of radiation to the tumor while sparing surrounding normal tissues. A new medical imaging method which is a combination of positron emission tomography (PET) and computed tomography (CT) scan, has shown promise in helping the radiation oncologist in defining the exact location and extent of the tumor in certain cancers such as lung cancers. Therefore the purpose of this study is to determine if these imaging methods can be used in combination with the standard radiation treatment planning procedure to improve the accuracy to targeting your tumor with radiation. In addition the PET-CT scan, similar to the PET scan alone with better resolution, can be used to determine whether the tumor has spread to any part of the body outside of the head and neck sites.


Eligibility criteria: Inclusion Criteria:Patients who are scheduled to receive radiation therapy for head and neck cancer at Stanford.

Exclusion Criteria:Non-Stanford patients.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Quynh-Thu Le
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00378469: Study of the Effects of Muscular Activity on Iron Metabolism
Official title: Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Iron Overload
Iron Deficiency
Keywords: Hepcidin
Hemojuvelin
Iron
Healthy volunteers
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2006-09-20
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will have to pedal on an ergocycle for 45 minutes, and urine and blood samples will be collected regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.

Detailed description: Hemojuvelin has been described as interfering with hepcidin, a key regulator of iron homeostasis. Hemojuvelin is mainly produced by muscle, and the relationship between exercise and iron metabolism can be questioned about.

The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will be investigated at two periods according to a cross-over design after:

1. 45 minutes of exercise on the ergocycle; and
2. no physical exercise.

Urine and blood samples will be collected at both periods regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.

Eligibility criteria: Inclusion Criteria:

* Male individuals aged between 18 and 40 years old
* Body mass index (BMI) between 18 and 25
* Normal at clinical examination
* Normal biological variables
* Written informed consent

Exclusion Criteria:

* Mutation C282Y of the HFE gene
* Iron metabolism abnormality
* Inflammatory syndrome
* Chronic pathology or ongoing treatment
* Tobacco smoking, alcohol consuming more than 30g/day
* History of transfusion or blood-giving within 3 months
* Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.

Primary outcomes:
measure: Pharmacokinetics of urinary hepcidin
measure: Pharmacokinetics of blood hemojuvelin
Secondary outcomes:
measure: Pharmacokinetics of urine and blood iron, transferrin, interleukin-6 (IL-6) and ferritin
Other outcomes:
Locations:
city: Rennes
country: France
facility: Service des Maladies du Foie - Hôpital de Pontchaillou
city: Rennes
country: France
facility: Unité de Biologie et Médecine du Sport - Hôpital de Pontchaillou
Study officials:
affiliation: Rennes University Hospital
name: Pierre Brissot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Bruno Laviolle, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01028469: Artelon Metatarsophalangeal (MTP) Spacer
Official title: Artelon MTP Spacer - Surgical Treatment of Mild to Moderate Hallux Rigidus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis
Hallux Rigidus
Lead sponsor: Artimplant AB
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this prospective, case series is to evaluate the surgical treatment of painful and disabling osteoarthrosis in the MTP-I joint by insertion of an Artelon MTP Spacer.


Eligibility criteria: Inclusion Criteria:

* The patient experiences pain and limitations of the great toe dorsiflexion at the MTP-I joint.
* The patient has a clinically and radiographically verified arthritis in the MTP-I joint indicating the need for surgical treatment.
* The patient reads, understands and is able to complete the study questionnaires in Swedish.
* The patient has received written and oral information regarding the study and has signed the informed consent form.

Exclusion criteria:

* The patient has a pronounced hallux rigidus without mobility in the MTP-I joint (ROM = 0°).
* The patient has previously received surgical treatment affecting the anatomy of the MTP-I joint.
* The patient has a systemic rheumatic disease, ongoing infection, hallux valgus or is seriously ill.

Primary outcomes:
measure: Pain, function and alignment of the treated toe evaluated by the investigator using the American Orthopeadic Foot & Ankle Society (AOFAS) clinical rating system.
timeFrame: pre-treatment and 12 months post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Sahlgrenska Universitetssjukhuset, Område Ortopedi, Mölndal
Study officials:
affiliation: Sahlgrenska University Hospital, Mölndal, Sweden
name: Martin Alund, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01482169: Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)
Official title: Efficacy of Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Left heart catheterization
Fractional flow reserve
Adenoscan®
Regadenoson
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Global Development, Inc.
First posted: 2011-11-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.

Detailed description: This is a prospective open label, single center pilot trial that will evaluate regadenoson compared to Adenoscan® to be given IV in the assessment of Fractional Flow Reserve. Forty eight subjects will be enrolled and get Adenoscan® administered via IV followed by Regadenoson IV.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective left heart catheterization
* Age ≥ 18 years (female not of child bearing potential)
* Able to provide written informed consent

Exclusion Criteria:

* Contraindications to administration of either Adenoscan® or Regadenoson
* High degree AV block, sick sinus syndrome without a functioning pacemaker
* Symptomatic bradycardia
* Recent STEMI (\< 5 days)
* Recent NSTEMI (\<5 days) if the peak CK is \> 1000 IU
* Dipyridamole use within 24 hours
* Adenoscan® is contraindicated (hypersensitivity to Adenoscan®, Regadenoson, or aminophylline
* Known severe bronchoconstrictive lung disease

Primary outcomes:
measure: Comparing Measurement of Fractional Flow Reserve (FFR)
timeFrame: DAY 1
Secondary outcomes:
measure: Duration to Baseline Hyperemia After Aminophylline Injection
timeFrame: seconds
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
Study officials:
affiliation: Ochsner Health System
name: Robert Bober, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02601469: Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis
Official title: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients With Plaque Psoriasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2015-11-10
Enrollment: 26
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open label, safety study to assess the potential for adrenal suppression following maximal use treatment with DSXS administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.

Detailed description: 1. The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe plaque psoriasis
2. To evaluate the efficacy parameters, pharmacokinetics and adverse event (AE) profile of DSXS

Eligibility criteria: Inclusion Criteria:

1. Patients with a confirmed diagnosis of plaque psoriasis, patients 2-17 years of age with ≥ 10% BSA affected and patients age 18 years of age or older with ≥ 20% BSA affected
2. Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
3. Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response

Exclusion Criteria:

1. Patients under 2 years of age.
2. Investigator Global Assessment (IGA) of less than 3 (moderate) or greater than 4 (severe) at baseline.
3. Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e., erythrodermic, exfoliative or pustular psoriasis).
4. Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response

Primary outcomes:
measure: Number of Participants With HPA Axis Suppression
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Taro Pharmaceuticals USA Inc.
state: New York
Study officials:
affiliation: http://www.novumprs.com/contact
name: Novum Pharmaceutical Research Services
role: STUDY_CHAIR
References:
Clinical trial NCT00167869: LACTOPRES:Study on the Effect of Dairy Peptides on Blood Pressure in Untreated Hypertensive Subjects.
Official title: LACTOPRES:Study on the Effect of Dairy Peptides on Blood Pressure in Untreated Hypertensive Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: hypertension
blood pressure
dairy peptides
bioactive peptides
randomized controlled trial
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Unilever R&D
First posted: 2005-09-14
Enrollment: 135
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypertension is an increasingly important medical and public health issue. Literature suggests that there may be a role for dairy foods in the prevention and treatment of hypertension. Recently, it has been suggested that several peptides in milk proteins could have blood pressure lowering properties. LACTOPRES is a randomised, double-blind parallel trial to assess the blood pressure effect of an increased intake of dairy peptides in humans.


Eligibility criteria: Inclusion Criteria:

* systolic blood pressure \>= 140 mmHg
* BMI between 18 and 32 kg/m2
* apparently healthy

Exclusion Criteria:

* antihypertensive medication
* medically prescribed or slimming diet
* lactating, pregnant
* irregular pulse

Primary outcomes:
measure: Blood pressure
Secondary outcomes:
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University, Division of Human Nutrition
Study officials:
affiliation: Wageningen University - Division of Human Nutrition
name: Frans J Kok, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01389869: Appetite Regulation by Human Chemosignals From Tears and Plasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Emotional tears
Postprandial plasma
Chemosignal
Obesity
Appetite
Food intake
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Obesity is closely related to metabolic diseases and its prevalence is sharply increasing. However, there is no safe and effective treatment for obesity so far, the investigators need a breakthrough idea to curtail the constant threat of obesity. It has been recently demonstrated that emotional tears of women can modify sexual responses, one of basic instincts, in men. As appetite and food intake is another basic instinct, chemosignals from tears and plasma may modify appetite and eating behavior in humans.


Eligibility criteria: Inclusion Criteria:

* Woman: Negative for HIV, Syphilis (VDRL), and Hepatitis B and C
* Man: Has a body mass index (BMI) of 18.5 kg/m2 to 27 kg/m2, inclusive.

Exclusion Criteria:

* Woman: Has eyelids inflammation, conjunctivitis, keratitis, lacrimal duct obstruction. Has skin diseases around eyes.
* Man: Has diabetes mellitus or dyslipidemia on medication. Received gastrointestinal surgery except appendectomy and hemorrhoidectomy.

Primary outcomes:
measure: The degree of appetite by visual analogue scale (VAS) and the amount of food intake by standard test meals in male volunteers while sniffing tears, trickled saline (control), and postprandial and fasting plasma in random order.
timeFrame: Visual analogue scale (VAS) will be rated 10 minutes after initial sniffing of tears/plasma just before eating standard test meals. The amount of food intake will be measured by weighing the meals before and after eating.
Secondary outcomes:
measure: Appetite regulating hormones(ghrelin, GLP-1, PYY), glucose, testosterone. Determination of tears, tickled saline, and plasma.
timeFrame: Blood samples for measuring appetite regulating hormones, glucose, testosterone will be collected at -10, 0, and 60 min.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine
name: Young Min Cho, MD, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT05435469: The Changes of Coping With Stressful Events Among Adolescents Under the COVID-19 Pandemic.
Official title: Study on the Changes of Coping Strategies With Stressful Events and Mental Health Level Among Adolescents Before and After COVID-19 Pandemic.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coping Behavior
Mental Health Issue
Keywords: adolescent
pandemic
coping behavior
mental health
stressful life event
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 4300
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General adolescents

Brief summary: This study aims to describe the changes in coping strategies used by adolescents for stressful life events under the background of epidemic normalization; and explore the causes of coping strategy changes of stressful life events under the background of normalization of the epidemic situation among adolescents.

Detailed description: Under the special background of normalization of the epidemic situation, this paper describes and discusses the subjective feelings, changes in coping strategies, and causes of adolescent stressful life events, and puts forward a coping mechanism model of stressful adolescent events, which reflects the psychological changes of adolescent groups in the era of the epidemic situation and provides the basis for subsequent intervention measures.

Eligibility criteria: Inclusion Criteria:

* Aged 14-25
* Chinese nationality, who has lived in China since the outbreak of the COVID-19 epidemic, and has experienced or is experiencing the epidemic and its normalization.
* Have the normal cognitive ability, expression ability, and social participation ability.

Exclusion Criteria:

* Be diagnosed with psychological or mental illness.
* Incapacitated or unable to provide informed consent.
* Patients with severe diseases.

Primary outcomes:
measure: Coping strategies used after the pandemic
timeFrame: Baseline
measure: Coping strategies used before the pandemic
timeFrame: Baseline
measure: Mental health
timeFrame: Baseline
measure: Emotional Intelligence status
timeFrame: Baseline
Secondary outcomes:
measure: Stressful Life Events after pandemic
timeFrame: Baseline
measure: Stressful Life Events before pandemic
timeFrame: Baseline
measure: Social support
timeFrame: Baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: XIAW
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Wei Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References: