louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00580918: Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients
Official title: Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Mild Traumatic Brain Injury
Keywords: Mild Traumatic Brain Injury
fMRI
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mild Traumatic Brain Injury Normal health controls

Brief summary: The purpose of this study will be to assess the attentional ability of patients with mild to moderate traumatic brain injury (TBI) using the functional Magnetic Resonance Imaging (fMRI) technique. Methodology for specific aim 1: sagittal pilot scan, 3-D anatomical MRI, Whole brain echo-planar imaging (EPI), and functional MRI techniques with traumatic brain injured subjects doing a Continuous Performance Test (CPT) attention task and compare the pattern of activation with those of normal controls to see if there is a failure to activate frontal lobes in the traumatic brain injured subjects.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate brain injury patients referred to the UCI Brain Imaging Center.

  * Mild brain injury patients will be defined as having a Glascow Coma Scale (GCS) scale of 13-15.
  * Moderate brain injury brain injury patients will be defined as having a Glascow Coma Scale (GCS) scale of 9-12 .
* Normal healthy control subjects (20)

Exclusion Criteria:

* Pre-accident neuropathology, psychopathology, or secondary neuropathological complications, or chemical abuse
* Patients who required intracranial surgical intervention
* Children, pregnant women, or institutionalized individuals unable to freely give consent
* Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material
* Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities
* Patients with permanent (tattoo) eye-liner or with facial make-up (severe eye irritation has been reported)
* Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion
* Patients with implanted prosthetic heart valves
* Patients with pacemakers, neuro-stimulation devices
* Subjects who have severe claustrophobia.

Primary outcomes:
measure: fMRI scans
timeFrame: three to four years post injury
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Joseph C Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06074718: Clinical Value of Prick Therapy Combined With Wheat Grain Moxibustion in the Treatment of Spleen Deficiency and Dampness Obstructed Cancer
Official title: Exploring the Therapeutic Effect of Pricking Therapy Combined With Wheat Grain Moxibustion on Malignant Tumors of Spleen Deficiency and Dampness Resistance Type
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pricking Therapy on the Back Shu Points
Wheat Grain Moxibustion on the Back Shu Points
Keywords: spleen deficiency and dampness obstructed
cancer
Lead sponsor: Jiangsu Taizhou People's Hospital
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the clinical efficacy and associated immune and inflammatory mechanisms in patients with malignant tumors of spleen deficiency and dampness resistance type, by applying pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Western medicine and traditional Chinese medicine for malignant tumors;
* Clinical diagnosis of spleen deficiency dampness obstruction in traditional Chinese medicine;
* Good compliance and signed informed consent form.

Exclusion Criteria:

* Patients who cannot lie prone for a long time;
* Pregnant women;
* Lactating women

Primary outcomes:
measure: Progression-Free Survival (ORR)
timeFrame: 3 years
Secondary outcomes:
measure: progression free survival (PFS),
timeFrame: 5 years
measure: overall survival (OS)
timeFrame: 5 years
measure: duration of remission (DOR)
timeFrame: 5 years
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Qingtao Ni
state: Jiangsu
Study officials:
References:
Clinical trial NCT04846218: Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle
Official title: Comparison Between Agonist Trigger With HCG Luteal Phase Supplementation vs HCG Trigger With Progesterone Luteal Phase Supplementation in Antagonist Controlled HyperstimulationCycle Regarding Clinical Pregnancy Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to compare agonist trigger and HCG luteal support vs standard HCG trigger and progesterone luteal supplementation in antagonist controlled hyperstimulation cycle as regards to clinical pregnancy rate.

Detailed description: Prospective Interventional randomized pilotstudy on patients undergoing controlled ovarian hyperstimulation.

All patients will receive a fixed dose of 150-300 IU recombinant FSH (Gonal-F; Sereno Laboratories,Madrid, Spain) for ovarian stimulation according to age, BMI and antral follicle count (AFC).

After 6 days of stimulation, FSH will be adjusted according to ovarian response.

Premature LH surge will be prevented with 0.25 mg of a GnRH antagonist (Cetrotide; Serono International, Geneva, Switzerland) starting on day 6 when two or more follicles reach a size of 18-20 mm, trigger of ovulation will be done and followed by luteal phase support according to the protocol assigned for each group.

Group 1:

A single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections

Group 2:

A single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).

Eligibility criteria: Inclusion Criteria:

* Age between 20 and 39 years.
* Body mass index between 18 and 30.
* Unexplained infertility or male factor infertility

Exclusion Criteria:

* Endocrinological disorder eg.:hyperprolactenemia, Hypo or hyper thyrodism
* More than 2 previous attemptsof IVF
* Any uterine anatomical anomaly.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams Maternity Hospital
Study officials:
References:
Clinical trial NCT02196818: A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup
Official title: A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Arthritis
Avascular Necrosis
Fracture of the Femoral Neck or Head
Congenital Hip Dysplasia
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2014-07-22
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary total hip arthroplasty

Brief summary: This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
* Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use).
* Patients must be willing to comply with the pre and post-operative evaluation schedule.

Exclusion Criteria:

* Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.

Primary outcomes:
measure: The Kaplan-Meier analysis as a measure of implant performance.
timeFrame: 5 years
Secondary outcomes:
measure: The Harris Hip Score.
timeFrame: pre-op, 3/6 months, 1,2 and 5 years
measure: Radiological analysis as a meausure of safety.
timeFrame: 3/6 months, 1,2 and 5 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: Vail Orthopedics, P.C.
state: Colorado
city: Boise
country: United States
facility: Saint Alphonsus Regional Medical Center
state: Idaho
city: Libertyville
country: United States
facility: Illinois Bone & Joint Institute, LLC
state: Illinois
city: West Jordan
country: United States
facility: Jordan Valley Medical Center
state: Utah
Study officials:
References:
Clinical trial NCT00092118: The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-24
Enrollment: 1992
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Non-smoker with a 2-year documented history of perennial allergic (symptoms that persist throughout the year) rhinitis symptoms and positive allergy testing

Exclusion Criteria:

* Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection

Primary outcomes:
measure: Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis
timeFrame: 6 week treatment period (from baseline though the end of week 6)
Secondary outcomes:
measure: Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period
timeFrame: At the end of the 6 week treatment period
measure: Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Patel P, Philip G, Yang W, Call R, Horak F, LaForce C, Gilles L, Garrett GC, Dass SB, Knorr BA, Reiss TF. Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2005 Dec;95(6):551-7. doi: 10.1016/S1081-1206(10)61018-6.
Clinical trial NCT06460818: Surgical Sample Collection- Sampling During Uterine Surgery
Official title: Surgical Sample Collection- Sampling During Uterine Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Women's Health
Lead sponsor: PinkDx, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-14
Enrollment: 234
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing hysterectomy.

Brief summary: The goal of this clinical trial is to evaluate anatomical locations for sample collection for future decisions for diagnostic test development.


Eligibility criteria: Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent form (ICF) indicating that the participant has been informed of all pertinent aspects of the study.
2. Willing and able to comply with scheduled visits, investigational plan, and other procedures.
3. Females:

   1. Aged \>45 for benign and pre-malignant cases
   2. Aged \>18 with positive biopsies.
4. Presence of uterus.
5. Scheduled for hysterectomy.

Exclusion Criteria:

1. Investigator site staff members directly involved in the conduct of the study and their family members or participants who are Pink Dx, Inc. employees or their family members.
2. Other acute or chronic medical or psychiatric conditions that would increase the risk associated with study participation in the judgement of the investigator.
3. Women who have undergone a hysterectomy.
4. Inability or unwillingness to sign informed consent.
5. Contraindication to surgery, including pregnancy.
6. Women who have used a tampon within 7 days of surgery.

Primary outcomes:
measure: Number of participants with optimal vaginal samples obtained during the collection process
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Columbia University
state: New York
city: Houston
country: United States
facility: Houston Methodist
state: Texas
Study officials:
affiliation: Mayo Clinic
name: Andrea Mariani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00596518: A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
Official title: A Phase 1, Open-Label Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PF-00734200 Administered To Subjects With Various Degrees Of Renal Impairment And Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency, Chronic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.


Eligibility criteria: Inclusion Criteria:

1. Subjects must meet one of the following renal function categories Normal renal function Mild renal impairment Moderate renal impairment End stage renal disease requiring chronic hemodialysis
2. Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg
3. Subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications

Exclusion Criteria:

1. Women who are pregnant, nursing or women of childbearing potential
2. Subjects with acute renal disease.

Primary outcomes:
measure: Area under the curve from time 0 until last observation (AUCtlast)
timeFrame: 3-6 days
measure: Maximum serum concentration (Cmax)
timeFrame: 3-6 days
Secondary outcomes:
measure: AUC extrapolated to infinity (AUCinf)
timeFrame: 3-6 days
measure: Time of Cmax (Tmax)
timeFrame: 3-6 days
measure: Half life (T1/2)
timeFrame: 3-6 days
measure: Renal clearance (CLr)
timeFrame: 3-6 days
measure: Hemodialysis clearance (CLd)
timeFrame: 3 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06780618: The Effects of Brown Rice Compared to White Rice on Postprandial Changes in IL-6 and MDA Levels in Sedentary Workers
Official title: The Effects of Brown Rice Consumption Compared to White Rice on Postprandial Changes in Interleukin-6 and Malondialdehyde Levels in Sedentary Workers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sedentary Employees
Postprandial Oxidation and inﬂammation
Keywords: brown rice
white rice
interleukin-6
malondialdehyde
sedentary
inflammation
oxidative stress
postprandial
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if brown rice and white rice affect oxidative stress and inflammation in office workers who don't exercise much. The main question it aims to answer is:

Does eating brown rice change MDA and IL-6 levels differently than eating white rice in people who don't exercise much?

Participants will:

Be interviewed to collect personal data, medical history, lifestyle habits, and dietary patterns.

Be measured to calculate Body Mass Index (BMI). Be interviewed to complete a questionnaire to assess their physical activity level in the past week.

Be interviewed to record all food and beverages consumed in the past 24 hours. Blood samples will be drawn twice, before and after consuming the research meal.

Be provided with a research meal consisting of rice (either brown or white), scrambled eggs, and tofu stew that must be finished within 15 to 20 minutes.


Eligibility criteria: Inclusion Criteria:

* healthy administrative employees,
* age 21-59 years,
* normal body mass index (18.5-22.9 kg/m2),
* low physical activity (≤600 METs minutes/week),
* assign for informed consent

Exclusion Criteria:

* being pregnant/breastfed/menopause,
* consumption of herbal medicines and/or supplements within 24 hours before data collection,
* having history of DM, CVD, cancer, and autoimmune disease,
* being vegan,
* smoking/alcohol drinking,
* allergic to research food's ingredients

Primary outcomes:
measure: The Effects of Brown Rice Consumption Compared to White Rice on Postprandial Changes in Interleukin-6 and Malondialdehyde Levels in Sedentary Workers
timeFrame: Enrollment process to fullfil sample size at 2 weeks. The intervention will be completed in 1 day.
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Faculty of Medicine University of Indonesia
Study officials:
affiliation: Department of Nutrition Faculty of Medicine University of Indonesia
name: Wulandari Taradita, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04181918: Action Observation Treatment in Parkinson's Patients
Official title: Action Observation Treatment and Motor Imagery as Rehabilitation Tools in Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson
Keywords: Action Observation Treatment
Motor Imagery
Randomized Controlled Study
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the role of Action Observation Treatment (AOT) and Motor Imagery (MI) in the rehabilitation of Parkinson's disease patients, as compared to a control condition. Main outcome measures will be the results in two functional scales (FIM, UPDRS) and kinematics parameters obtained from gait analysis. Data at two months and six months follow up, respectively, will be also collected.


Eligibility criteria: Inclusion Criteria:

* Parkinson disease patients on Hoehn and Yahr 3-4

Exclusion Criteria:

* Mini-Mental State Examination \< 24
* Fluent aphasic patients
* Apraxia
* Neglect
* major neuropsychiatric disorders

Primary outcomes:
measure: change in the functional status of the patient
timeFrame: Before treatment, within one week after treatment, two months' follow up
measure: change in Parkinson disease motor symptoms
timeFrame: Before treatment, within one week after treatment, two months' follow up
measure: change in kinematic parameters of the gait (velocity, footing, pace, step length)
timeFrame: Before treatment, within one week after treatment, two months' follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Fondazione Don Carlo Gnocchi
Study officials:
affiliation: Istituto Don Gnocchi
name: Giovanni Buccino
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Don Gnocchi
name: Claudio Rovacchi
role: STUDY_CHAIR
References: