louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03476668: Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.
Official title: Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Attention Disturbances
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The researchers aimed to investigate the relationship between the asymmetric dopaminergic degeneration and the attentional resources in a group of patients with Parkinson's disease (PD).

Detailed description: To bypass the impaired habitual motor-behavioural control, Parkinson's disease (PD) patients may exploit the network of goal-directed mode of action. The frontostriatal connections underline this functioning, that is based on attention. Since the cognitive processes are related with dopamine, the asymmetrical degeneration of the dopaminergic system affects differently the right side affected (RPD) and the left side affected (LPD) PD patients.

The aim of the study was to investigate the relationship between the asymmetric dopaminergic degeneration and the attentional resources in a group of patients with PD.

Eligibility criteria: Inclusion Criteria:

* Stage 2.5-3 according to the Hoehn and Yahr scale (H\&Y);
* Stable pharmacological treatment for the last 6 weeks before the enrolment and during the hospitalization;
* Mini Mental State Examination (MMSE) ≥ 24;
* No evidences of dysexecutive syndrome.

Exclusion Criteria:

* Any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous 12 months;
* Drug-induced dyskinesias;
* Disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of UPDRS III;
* Behavioral disturbances (evaluated with Neuropsychiatric Inventory);
* Visual and auditory dysfunctions according to the general clinical evaluation and medical history;
* Equivocal report about the side of disease onset or bilateral motor involvement.

Primary outcomes:
measure: Visual Reaction Times (V RTs)
timeFrame: 4 weeks
measure: Auditory Reaction Times (A RTs)
timeFrame: 4 weeks
measure: Multiple Choices RTs (MC RTs)
timeFrame: 4 weeks
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 4 weeks
measure: Timed Up and Go Test (TUG)
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: epartment of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
name: Giuseppe Frazzitta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04208568: Comparison of Postoperative Pain After Gallbladder Retrieval From Umbilical and Epigastric Ports.
Official title: Gallbladder Counting on Epigastric Site;A Randomized Trial Comparing Postoperative Pain After Gallbladder Retrieval From Umblical and Epigastric Port Site in Laproscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholelithiasis
Lead sponsor: Baqai Medical University
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To know the association of postoperative pain after gallbladder removal from umbilical port site versus epigastric portsite, after four ports laparoscopic cholecystectomy,and the epigastric port site was found to be friendly for the patients in terms of less pain after gallbladder removal from this site after surgery.

Detailed description: Objective: To know the association of postoperative pain after gallbladder removal from umbilical port site versus epigastric port site, after four ports laparoscopic cholecystectomy.

Randomized controlled trial was performed during 1-year period from January 2017 till January 2018, at a private hospital setup. Both male and female patients, with age group 18 and above, in years, were considered, who were planned four ports laparoscopic cholecystectomy after typical cholelithiasis. Those patients with polyps , mucocele or empyema in gallbladder or perforated gallbladder requiring emergency surgery were omitted from the study. The patients were randomly selected, 65 in which gallbladder was removed from umbilical region (group A) and 65 from epigastric region (group B) respectively. Determination of postoperative pain was done on day one, at the time of release from the hospital and at follow-up time one-month post-surgery, with the help of Numerical Analogue Scale (NAS).

Eligibility criteria: Inclusion Criteria:

* All healthy patients without cholecystitis

Exclusion Criteria:

* Acute cholecystits, mucocoele, empyema, carcinoma, peritonitis, ASA 3 and 4

Primary outcomes:
measure: comparison of postoperative pain after laparoscopic cholecystectomy between umbilical and epigastric port sites, using Numerical Analogue Scale (NAS).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05724368: Efficacy of Calprotectin as A Marker For the Pathogenicity of Blastocystis Infection
Official title: Efficacy of Calprotectin as A Marker For the Pathogenicity of Blastocystis Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blastocystis Infections
Keywords: Blastocystis
Calprotectin
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: samples will be collected from outpatients with any age \& sex groups from different locations (cities and villages).

Brief summary: Blastocystis which is commonly found in the gastro-intestinal tract, has been recognized as a non-pathogenic organism for a few decades. It has a variable distribution. A high prevalence has been reported in developing countries (22.1-100%).

In developed countries, the prevalence ranges from 0.5% to 23.1%. The high prevalence noted in developing countries is related to poor hygiene and lack of safe water and food .

Detailed description: Blastocystis which is commonly found in the gastro-intestinal tract, has been recognized as a non-pathogenic organism for a few decades. It has a variable distribution. A high prevalence has been reported in developing countries (22.1-100%).

In developed countries, the prevalence ranges from 0.5% to 23.1%. The high prevalence noted in developing countries is related to poor hygiene and lack of safe water and food. The pathogenicity of Blastocystis is controversial because most patients carrying this parasite are asymptomatic. Several studies have considered Blastocystis sp. as a commensal micro-organism, while other results have showed the pathogenicity of the parasite.

Calprotectin (CP), a calcium-binding protein, comprises 60% of cytosolic protein found in neutrophils. Fecal calprotectin (F-CP) concentration is an indicator of neutrophil migration into the intestinal lumen and is associated with intestinal inflammation.

Eligibility criteria: Inclusion Criteria:

* Patients from outpatient clinics, Sohag hospitals.

Exclusion Criteria:

* Patients taking antibiotics within the previous four weeks, and anti-parasitic drugs within the previous two weeks.

Primary outcomes:
measure: level of fecal calprotectin
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03992768: Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
Official title: Clinical Validation for Feature Detection Precision by WSI Using Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pathology
Lead sponsor: Hamamatsu Photonics K.K.
Sponsor class: INDUSTRY
First posted: 2019-06-20
Enrollment: 540
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging

Detailed description: The study will be conducted under the following 3 sub-studies:

1. Scans within Scanner (Intra-scanner precision substudy),
2. Scanners within a site (Inter-scanner precision substudy),
3. Scanners between sites (Inter-site precision substudy)

Eligibility criteria: Inclusion Criteria:

Glass slides are screened for the known features and will be considered eligible for the study only if all of the following criteria apply:

* Slides are selected from cases in a consecutive manner starting with cases at least 1 year old since accessioning
* Slide is a glass cover-slipped surgical pathology slide of human tissue
* Slide is stained with hematoxylin and eosin (H\&E) or other stains
* Slide has the designated primary feature in the FOV, which is readily observable in its natural environment although the slide may also have one or more secondary features from the same magnification group in the FOV.
* Slide is available in the archives for use, or purchased commercially, is not damaged, has tissue on the slide which is still in good condition, has a stain that is not faded and otherwise passes all quality checks

Exclusion Criteria:

Slides are to be excluded from the study if any of the following criteria apply:

* Slide is unable to be scanned, contains damaged tissue or has indelible markings
* Slide comes from an active (less than 1 year old) case
* Slide is from a patient who already has a slide enrolled in the study, only 1 slide per patient to be enrolled

Primary outcomes:
measure: Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Anil Parwani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04225468: Safe Options for ACL Recovery
Official title: Safe Options for ACL Recovery: An Opioid Exposure Reduction Program for Anterior Cruciate Ligament Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Opioid Use
Keywords: prevention
opioid exposure
exposure reduction
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: University of Memphis
name: Campbell Clinic
First posted: 2020-01-13
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the proposed work is to test a brief opioid exposure reduction program (ACL-OERP) designed to improve health literacy about opioid use following surgeries. This intervention is specifically designed to be used with patients (or for patients under 18, the patient and caregiver) undergoing Anterior Cruciate Ligament (ACL) reconstruction, a painful surgery that is often followed by at least 7 days of opioid medication.

Detailed description: The goal of this study is to test whether the ACL-OERP intervention (vs. a treatment as usual \[TAU\] comparison) improves knowledge of (1) risks associated with opioid self-administration (development of tolerance, dangers of concomitant sedative use, taking as prescribed for safety), (2) expected pain following ACL reconstruction, (3) accurate pain assessment, (4) and weaning from opioid to non-narcotic analgesics.

There will be one control arm (TAU) and two intervention arms, both of which are experimental. Both will receive the ACL-OERP before surgery, and the second arm will also receive a "booster" intervention session of the intervention 3 days after surgery.

In addition, investigators wish to compare the amount of opioid self-administered in the intervention groups (vs. TAU comparison) to assess whether this knowledge reduces self-administration of opioid. The project will also examine whether the implementation of the booster intervention session in the third arm improves these outcomes compared to the other intervention arm.

Eligibility criteria: Inclusion Criteria:

* Presenting for a pre-operatory appointment at the study site for ACL reconstruction with patellar tendon autograft surgery.
* Be able to return to the clinic at least one time within the first 10 days post-op.

Exclusion Criteria:

* Under 12 years of age
* Contraindication to opioids
* Unable to understand intervention material in English

Primary outcomes:
measure: Total morphine milligram equivalents administered
timeFrame: Assessed at 30 days post surgery
Secondary outcomes:
measure: Knowledge of safe opioid use
timeFrame: Assessed at baseline and 7-days post surgery
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
References:
Clinical trial NCT05474768: Expectations and Beliefs of Transgender People Regarding Hormonal Treatment
Official title: Expectations and Beliefs of Transgender People Regarding Hormonal Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transgenderism
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults with gender dysphoria and parent of adolescent/child presenting gender dysphoria, who are followed un the university hospital of Nancy

Brief summary: Hormonal treatment of gender dysphoria can have repercussions on metabolism, cardiovascular system and fertility and represents à potential oncological risk. According to the recommendations of the Endocrine society. Therefore, initial assessment and follow-up visits are necessary and must be carried out to avoid the apparition of potentially undesirable effects.


Eligibility criteria: Inclusion Criteria:

* being a parent of adolescent/child presenting Gender dysphoria
* adult subject (age \> 18 years) presenting Gender dysphoria

non-inclusion criteria

* Severe, uncontrolled psychiatric or somatic illness
* Chronic alcoholism
* Substance abuse
* Refusal or linguistic, physical or psychological incapacity to participate in the study
* Ongoing pregnancy

Primary outcomes:
measure: Describe expectations and beliefs of transgener people about hormonal therapy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
References:
Clinical trial NCT01379768: Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear
Official title: Polymorphonuclear Leukocyte Response During Overnight Lens Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Blood Cells
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: University of Waterloo
First posted: 2011-06-23
Enrollment: 65
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study was to count and analyze the white blood cells in tear samples collected from study participants following sleep. The results from contact lens wearers were compared with the results from non-contact lens wearers.

Detailed description: The objective of the study was to determine and compare the relative oxidative response of polymorphonuclear neutrophils (PMNs), the relative cell adhesion response of PMNs, and the leukocyte population in tear samples collected from contact lens wearers and non-contact lens wearers. Tear samples were collected via a binocular eye-wash. The samples were processed, and a cell count was performed using a hemacytometer. Flow cytometry was used to determine the expression of different PMN cell markers before and after stimulation with bacterial lipopolysaccharide (LPS).

Eligibility criteria: Inclusion Criteria:

* 17 years of age or older.
* Ocular examination in the last two years.
* Has up-to-date spectacles.
* Falls into one of the following three categories:

  * Adapted wearer of Lotrafilcon A contact lenses
  * Adapted wearer of Lotrafilcon B contact lenses
  * Does not wear contact lenses
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Ocular disease
* Systemic or topical medications that may affect ocular health.
* Known sensitivity to diagnostic pharmaceuticals used in study.
* Uses artificial tears and/or rewetting drops.
* Wears contact lenses on an overnight basis for more than one night per week.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Leukocyte Population
timeFrame: Week 5
measure: Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)
timeFrame: Week 5
measure: Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)
timeFrame: Week 5
measure: Change From Week 1 in Leukocyte Population at Week 5
timeFrame: Week 1, Week 5
measure: Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5
timeFrame: Week 1, Week 5
measure: Change From Week 1 in Relative Oxidative Response of PMNs at Week 5
timeFrame: Week 1, Week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo Centre for Contact Lens Research
state: Ontario
Study officials:
affiliation: Centre for Contact Lens Research, School of Optometry, University of Waterloo
name: Lyndon Jones, PhD FCOptom FAAO, Director
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01254968: Influence of Direction of Movement While Walking
Official title: Influence of Direction of Movement While Walking Upon the Blood Flow Rate Through Brain, Examined by Transcranial Doppler Sonography in Young Healthy Subjects.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Changes in Blood Flow to the Brain
Changes Depending on the Form of Walking
Keywords: blood flow in the middle cerebral artery of brain
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 healthy subjects (11 men, 9 women, average age 23.94) participated in a study measuring the speed of blood flow in middle cerebral arteries using transcranial Doppler (transcranial Doppler Sonography) while walking on a treadmill.

Brief summary: The aim of the study is evaluation of cerebral blood flow (based on testing the rate of flow in middle cerebral arteries by transcranial Doppler ultrasound) during different forms of walking training - walk forwards and backwards, with closed and open eyes.

Detailed description: In the third minute of training walking a significant increase in blood flow velocity was recorded, both in right and left middle cerebral arteries. It was observed in the left artery during all forms of training. In the right artery it occurred only during three forms of difficult training, and was preceded by significant decrease in blood flow in the first minute of the gait with eyes closed. The output values of the rate of blood flow in both right and left middle cerebral arteries became progressively reduced in the successive stages of gait. Pressure and pulse rates did not correlate with the variables of blood flow velocity in middle cerebral arteries.

Eligibility criteria: Inclusion Criteria:

* healthy subjects without brain disease

Exclusion Criteria:

* brain disease and walking disfunctions

Primary outcomes:
measure: Transcranial Doppler sonography in young healthy subjects.
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Medical University of Silesia
state: Silesia
Study officials:
References:
Clinical trial NCT02454868: Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade
Official title: Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Underdosing of Unspecified General Anesthetics
Keywords: Remifentanil
Intubation
Children
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
Collaborators: name: University of Brasilia
First posted: 2015-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction: remifentanil's optimal dose for children intubation without neuromuscular blockade is unknown. Method: phase IV adaptative trial using Dixon's up-and-down method for modeling remifentanil's dose-response curve for adequate intubation conditions as defined by previous studies.

Detailed description: Introduction: remifentanil's optimal dose for children intubation without neuromuscular blockade is unknown.

Method: phase IV adaptative trial using Dixon's up-and-down method for modeling remifentanil's dose-response curve for adequate intubation conditions as defined by previous studies. Remifentanil doses starting from 2mg/kg will be infused before intubation. When a success occurs next patient's dose will be decreased by 0.25mg/kg/h. When a success does not occur the next patient's dose will be increased by 0.25mg/kg/h. Intubation will be considered adequate if patient does not cough, does not move, if vocal cords are open, if larigocsocpic Cormack grade I or II.

Eligibility criteria: Inclusion Criteria:

* ASA I or II
* Scheduled for surgery under general anesthesia.

Exclusion Criteria:

* Predicted difficult airway
* Severe neurologic or cardiologic conditions
* Recent upper airway infectious diseases

Primary outcomes:
measure: Incidence of Adequate intubation condition (dichotomic) as an assessment of success rate
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Brasilia
name: Catia S Goveia, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ono AH, Moura TR, Goveia CS, Guimaraes GMN, de Araujo Ladeira LC, da Silva HBG. ED50 of remifentanil for providing excellent intubating conditions when co-administered with a single standard dose of propofol without the use of muscle relaxants in children: dose-finding clinical trial. J Anesth. 2018 Aug;32(4):493-498. doi: 10.1007/s00540-018-2502-z. Epub 2018 May 4.