louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03383497: The Clinical Profile of Parkinson Disease in Egypt
Official title: The Clinical Profile of Parkinson Disease in Egypt: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 1237
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinsonian syndromes

Brief summary: Multi-center, retrospective observational cohort study in 4 tertiary referral centers in Cairo over the period from 2004 to 2016.

Study population. including all patients with idiopathic Parkinson disease attending. Patients were diagnosed in accordance to the United Kingdom - Parkinson Disease Society Brain Bank criteria.

Detailed description: Retrospective, observational study that involve Medical Record Review (MRR). Data extraction and collection from medical records was organized through an electronic structured data collection form by two of authors (H.S and N.S).

The abstraction documents included; patient's age, sex, family history, age at onset, type and side of motor symptoms onset, associated non-motor manifestations. Moreover; management plan, drug history, outcome and disease progression were also verified and recorded.

During medical record reviewing (MRR); any missing documentation or poorly recorded information was managed by deleting the case.

Eligibility criteria: Inclusion Criteria:

* All patients with Parkinsonian syndromes

Exclusion Criteria:

* Records with missing operationalized variables from patient records

Primary outcomes:
measure: time to L-Dopa start
timeFrame: 6 - 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04094597: Safety and Efficacy of Oral Bovine Lactoferrin
Official title: Effectivness and Safety of Oral Bovine Lactoferrin in Neonatal Sepsis and Necrotizing Enterocolitis and Its Effect on Anaemia of Prematurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Neonatal SEPSIS
Keywords: lactoferrin
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
First posted: 2019-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo group 100 patient will receive 2 ml saline for one month in comparison with oral lactoferrin for the same period to another 100 patient
Primary purpose: PREVENTION

Brief summary: Oral lactoferrin versus Placebo will be given to preterm neonates

Detailed description: 200 patient were included in the study , one hundred received oral placebo in the form of 2 ml saline , the other 100 preterm neonates received oral lactoferrin with monitoring of C-reactive protein , different cultures, complete blood count on day 7 and after one month.

Eligibility criteria: Inclusion Criteria:

All neonates born at Cairo university hospital NICU

Exclusion Criteria:

* Neonatal deaths before 3 days postnatal .
* Neonates with underlying gastrointestinal problems that prevent oral intake.
* Neonates with major congenital anomalies .
* Neonates with severe hypoxic ischemic encephaloapathy .
* Neonates whose parents refuse to participate.

Primary outcomes:
measure: Change in mortality rate of neonatal sepsis in preterm neonate
timeFrame: one year
measure: Number of Preterm Neonates who will have long term Complication after one month of regular use of Lactoferrin
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ayman
state: Assuit
Study officials:
affiliation: Cairo University
name: ayman zaher, bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02881697: mTOR and Adipose Tissue Inflammation
Official title: mTOR and Adipose Tissue Inflammation in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients (BMI \>35 kg/m2) with insulin resistance and lean controls (BMI \< 27kg/m2) scheduled for elective surgery for non-inflammatory conditions such as gallstone disease, diverticular disease or - in the case of obese subjects - bariatric surgery

Brief summary: The target of rapamycin complex 2 (TORC2) is an evolutionarily conserved serine/threonine protein kinase that controls growth and metabolism. In mammals (including humans), mammalian TOR complex 2(mTORC2) contains mammalian TOR (mTOR), RICTOR, mSIN1 protein, and mLST8 gene. In an animal model, the adipose-specific rictor knockout (AdRiKO) mouse, systemic insulin resistance, hepatic steatosis, and cardiovascular dysfunction develop upon high fat diet (HFD)-induced obesity or aging. To find a molecular link between adipose mTORC2 and systemic insulin resistance, investigators have already performed transcriptomics and proteomics analysis on visceral white adipose tissue in a mouse model. The aim of the study is to confirm a molecular link between adipose mTORC2 and systemic insulin resistance in humans.


Eligibility criteria: Inclusion Criteria:

* Obese volunteers (BMI \> 35kg/m2) aged 18 to a maximum of 60 years, males and females; insulin-resistant, scheduled for elective bariatric surgery.
* Normal weight patients (BMI \< 27kg/m2) aged 18- max. 60 years, males and females; insulin-sensitive, scheduled for elective surgery.

Exclusion Criteria:

* Known diabetes mellitus
* Chronic inflammatory disease (inflammatory bowel disease, rheumatoid disease, cancer)
* Acute inflammatory disease
* Known renal disease: kidney failure
* Pregnancy:
* history of gastrointestinal surgery with major changes to the gastrointestinal tract (removal of stomach, any GI-bypass)
* Substance abuse, alcohol abuse
* Inability to follow procedures due to psychological disorders, dementia
* insufficient knowledge of project language (German)

Primary outcomes:
measure: mTORC2 activity in adipose tissue measured by immunoblot
timeFrame: single time point at surgery
Secondary outcomes:
measure: Mcp1 messenger ribonucleic acid (mRNA) level in adipose tissue measured by quantitative polymerase chain reaction (PCR)
timeFrame: single time point at surgery
Other outcomes:
measure: Insulin resistance measured with fasting plasma insulin and fasting glucose
timeFrame: single time point at surgery
Locations:
Study officials:
affiliation: St. Claraspital klinische Forschungsabteilung
name: Christoph Beglinger, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01038297: Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
Official title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED, DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF EXC 001 FOR THE TREATMENT OF INCISION SCARS IN THE PANNUS OF SUBJECTS UNDERGOING AN ELECTIVE ABDOMINOPLASTY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scar Prevention
Keywords: Scarring
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects must have sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty
* Subject has chosen to have an elective abdominoplasty
* Medically healthy with normal screening results
* Subjects must not be pregnant or lactating

Exclusion Criteria:

* Subjects with existing scars or significant striae on the abdominal pannus
* Females who are currently pregnant or pregnant during the 12 months prior to inclusion in the study, or lactating
* Participation in another clinical trial within 30 days prior to the start of the study
* Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study

Primary outcomes:
measure: Part B: Expert Panel Scar Assessment Score
timeFrame: Week 13 of Part B
Secondary outcomes:
measure: Part B: Physician Observer Global Assessment Scar Score
timeFrame: Week 13 of Part B
measure: Part B: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Part B: Day 1 up to Week 14
measure: Part B: Number of Participants With Clinically Significant Changes in Physical Examination Findings
timeFrame: Part B: Day 1 up to Week 14
measure: Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings
timeFrame: Week 13 of Part B
measure: Part B: Number of Participants With Clinically Significant Abnormal Laboratory Findings
timeFrame: Part B: Day 1 up to Week 13
measure: Part A and B: Number of Participants With Positive Skin Sensitivity Reaction
timeFrame: From Day 21 of Part A up to Week 2 of Part B
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University,Division of Plastic Surgery
state: Illinois
city: Saint Louis
country: United States
facility: Body Aesthetic Plastic Surgery
state: Missouri
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03824197: Auburn University Research on Olive Oil for Alzheimer's Disease (AU-ROOAD)
Official title: Extra-virgin Olive Oil Prevents Mild Cognitive Impairment Conversion to Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Cerebral Amyloid Angiopathy
Lead sponsor: Auburn University
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 25
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Until now there is no medical treatment and/or intervention that can slow, stop or reverse the underlying neurodegenerative of Alzheimer's disease (AD). The goal of this study is to demonstrate "Oleocanthal rich-extra-virgin olive oil (EVOO) consumption stops or delay mild cognitive impairment conversion to AD by restoring the blood-brain barrier (BBB) function in humans".

Specific Aims:

1. Evaluate effect of EVOO on the brain function by functional MRI (fMRI) imaging, and BBB function by dynamic contrast-enhanced MRI (DCE-MRI).
2. Evaluate effect of EVOO on cognitive function and on selected biomarkers


Eligibility criteria: Inclusion Criteria:

Men and women, experiencing mild cognitive impairment with:

1. Mini-Mental State Exam (MMSE) scores between 18-30 (based on education level
2. memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory VI
3. Clinical Dementia Rating (CDR) score 0.5.

Exclusion Criteria:

1. Subjects with contradictions for MRI include: the presence of metal or electronic devices such as metallic joint prostheses, artificial heart valves, an implantable heart defibrillator, a pacemaker, metal clips, cochlear implants, a bullet, shrapnel or any other type of metal fragment; breathing problems or disorders, claustrophobia, inner ear disorders, vertigo or dizziness, tattoos or permanent makeup that contains metal, and body piercing jewelry that cannot be removed.
2. Subjects will be excluded if they are smokers
3. Subjects who have have clinically important medical or neuropsychiatric comorbidity.
4. Subjects who have renal problems or are allergic to the MRI contrast agent.

Primary outcomes:
measure: Effect of olive oil on the BBB intactness
timeFrame: 6 months
measure: Effect of olive oil on the brain activity
timeFrame: 6 months
Secondary outcomes:
measure: Cognitive function
timeFrame: 6 months
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
affiliation: Auburn University
name: Amal Kaddoumi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06961097: The Effect of Virtual Reality on Women Undergoing Endometrial Biopsy
Official title: The Effect of Virtual Reality Glasess Application on Pain and Anxiety in Women Undergoing Endometrial Biopsy:A Randomized Controlled Research
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometrial Biopsy
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim was to determine the effect of nature sounds and images that will be shown to women who underwent endometrial biopsy by using virtual reality glasses on pain and anxiety.

Hypotheses H0: Virtual reality glasses have no effect on women's pain and anxiety during endometrial biopsy.

H1: Virtual reality glasses have an effect on women's pain and anxiety during endometrial biopsy.

The study will be carried out in two different groups. The practice will start with meeting the women who apply to the Radiology clinic for an endometrial biopsy. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Virtual Reality Group In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After being taken to the gynecological table for the HSG procedure, the women included in the experimental group will be made to watch a video lasting an average of 15 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing nature sounds music of the video will be played in the practice room with a bluetooth speaker.

Control Group Patients in the control group of the study will not be subjected to any treatment other than the routine procedure.


Eligibility criteria: Inclusion Criteria:

* \*Being over 18 years old

  * Speaking and understanding Turkish
  * Being willing to participate in the research

Exclusion Criteria:

* Not volunteering to participate in research \* Not speaking or understanding Turkish

Primary outcomes:
measure: Numerical Pain Scale
timeFrame: immediately before the endometrial biopsy procedure and immediately after the endometrial biopsyprocedure
measure: Change in anxiety
timeFrame: immediately before the endometrial biopsy procedure and immediately after the endometrial biopsyprocedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01640197: Chronic Resveratrol Supplementation in Healthy Humans
Official title: The Effects of Chronic Trans- Resveratrol Supplementation on Aspects of Cognitive Performance, Mood, Sleep, Health and Cerebral Blood Flow in Healthy, Young Humans.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Cognitive performance
Cerebral blood flow
Subjective sleep
Subjective mood
Subjective health
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Biotivia Longevity Bioceuticals
First posted: 2012-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The effects of chronic resveratrol supplementation have yet to be investigated in healthy humans. It is hypothesised that the effects will be different to those seen in acute supplementation. This study will look specifically at cognitive performance, cerebral blood flow, subjective sleep, mood and health, blood pressure and plasma levels of resveratrol. It is hypothesized that these measures will be affected differently by acute and chronic supplementation.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Between 18-35
* At least enrolled on undergraduate degree programme
* Native English speaker

Exclusion Criteria:

* Smoking
* Taking other medication/ supplements
* Pregnant/ breast feeding
* High caffeine consumers
* Migraine sufferers

Primary outcomes:
measure: Chronic Modulation of Cerebral Blood Flow
timeFrame: 40- 80 minutes post- dose on day 28 of supplementation
Secondary outcomes:
measure: Number of Participants With Modulated Mood
timeFrame: 28 days
measure: Number of Participants With Modulated Cognitive Performance
timeFrame: 28 days
measure: Number of Participants With Significant Modulation of Sleep
timeFrame: Day 28
measure: Number of Participants With Significant Modulation of Health
timeFrame: Day 28
measure: Number of Participants With Significant Modulation of Blood Pressure
timeFrame: 28 days
measure: Number of Participants With Significant Modulation of CBF in MCA
timeFrame: 28 days
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Brain performance and nutrition research centre, Northumbria university
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: David O Kennedy, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05606705: A Study of Baked Milk Tolerance to Treat Eosinophilic Esophagtis
Official title: A Pilot Trial of Baked Milk Introduction in Patients with Milk-triggered Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Eosinophilic Esophagitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research is being done to see if patients with milk-triggered EoE are able to tolerate baked milk in their diet and if there is a threshold amount of straight milk that is tolerable.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Eosinophilic esophagitis ≥ 15 eosinophils per HPF
* Going through or completed the six-food elimination diet, with milk only or milk plus one additional food identified as a trigger

Exclusion Criteria:

* Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
* Topical swallowed steroids within 8 weeks of study enrollment
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Primary outcomes:
measure: Histological remission
timeFrame: 6 weeks
Secondary outcomes:
measure: Symptomatic remission
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Karthik Ravi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01008605: Caverject User Study
Official title: Representative Users Study Of Operating Characteristics Of The Caverject Delivery System.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 48
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to demonstrate the usability of the system.

Detailed description: demonstrate usability

Eligibility criteria: Inclusion Criteria:

Age 40 to 70

Exclusion Criteria:

Prior syringe skills

Primary outcomes:
measure: Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System
timeFrame: Day 1
Secondary outcomes:
measure: Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1
timeFrame: Day 1
measure: Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2
timeFrame: Day 1
measure: Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3
timeFrame: Day 1
measure: Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4
timeFrame: Day 1
measure: Time Required to Perform Each Step While Using the Caverject Impulse Delivery System
timeFrame: Day 1
measure: Number of Participants Providing Comments to Any Question on the Participant Assessment Tool
timeFrame: Day 1
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05058105: Safety, Tolerability, Pharmacokinetics of Intravenous FL058 and Meropenem in Healthy Subjects(SAD/MAD)
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous FL058 and Meropenem Alone and in Combination in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy adults aged between 18 and 45 years (inclusive).
2. Body mass index (BMI) ranges from 19 to 26 kg/m2 (inclusive), and the body weight is ≥50kg.
3. Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests.
4. Provide voluntary written informed consent prior to any study procedures and are willing and able to comply with the prescribed treatment protocol and evaluations.

Exclusion Criteria:

1. Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders.
2. Positive screen result for HBsAg, HCV-Ab, or HIV-Ab at screening.
3. History of clinically significant food or drug allergy.
4. A QT interval corrected using Fridericia's formula \>450 msec.
5. eGFR\<90mL/min/1.73m2.

Primary outcomes:
measure: Number of patients with adverse events [Safety and Tolerability]
timeFrame: Day 1 to Day 24
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
Study officials:
References: