louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01391637: Long-Term Follow-Up Study of Human Stem Cells Transplanted in Subjects With Connatal Pelizaeus-Merzbacher Disease (PMD)
Official title: Long-Term Follow-Up Safety and Preliminary Efficacy Study of Human Central Nervous System Stem Cell (HuCNS-SC®) Transplantation in Subjects With Connatal Pelizaeus-Merzbacher Disease (PMD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelizaeus-Merzbacher Disease
PMD
Keywords: Long term follow-up
HuCNS-SC cells
human central nervous system stem cells
Lead sponsor: StemCells, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 4
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PMD Subjects who underwent transplantation of HuCNS-SC cells under CL-N01-PMD study

Brief summary: The purpose of this study is to determine the long term safety and preliminary effect of HuCNS-SC cells transplanted in subjects with Connatal Pelizaeus-Merzbacher Disease (PMD).

Detailed description: Only subjects who underwent HuCNS-SC transplantation under Protocol CL-N01-PMD will be enrolled in this long term follow-up study.

Subjects will return to the site six months and one year after completion of the Phase I study and then annually for a total study duration of four years. Phone calls will also be made by the Investigator to the subject's parent/legal guardian bi-annually to conduct a phone visit through the four-year duration of the study.

Eligibility criteria: Inclusion Criteria:

* Subjects who received HuCNS-SC cells under Protocol CL-N01-PMD

Exclusion Criteria:

* Subjects who received off-protocol immunosuppressive medications.
* Subjects who are concurrently enrolled in another investigational study.

Primary outcomes:
measure: Incidence of serious adverse events (SAEs), results of physical and neurological examination, laboratory tests and vital signs.
timeFrame: 4 years
Secondary outcomes:
measure: Preliminary efficacy using Bayley-III and Callier-Azusa Scale.
timeFrame: 4 years
measure: Changes in brain magnetic resonance imaging (MRI), electroencephalogram (EEG), seizure frequency and somato-sensory evoked potentials (SSEP).
timeFrame: 4 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
Study officials:
affiliation: StemCells, Inc.
name: Stephen Huhn, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04668937: Conséquences of the COVID-19 Lockdown Measures on the CHRU Nancy Pediatric Emergency Services
Official title: Conséquences of the COVID-19 Lockdown Measures on the CHRU Nancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Number of Patients During the Studying Period
Reason for Consultation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 11000
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children who came to the Nancy's Pediatric emergencies during the period of the 18 march to the 30 June 2019 and 2020

Brief summary: The first period of COVID 19 Lockdown Measures (From 18 March to 11 may 2020) change the French people way of life and their medicine knowledges. A study which evaluates the Nancy's Pediatric emergencies population utilization during this time could detect pathological changes. The medical impact of Home Confinement will show an increase (trauma, maltreatment) or decrease (virus disease) of several pathology. The study aims to help clinicians to the children care if another time of Home Confinement happened. The main objective is to evaluate the behavioural changes and the reason consultation in Nancy's Pediatric Emergencies from 18 March to 30 June 2020 comparate to the same time in 2019. We will continue the search after the end of Home Confinement until 30 June 2020 to evaluate what happened just after.


Eligibility criteria: Inclusion Criteria:

* children who are cared during the study period to the Nancy's pediatric emergencies

Exclusion Criteria:

* be more than 18 years old
* Not being seen by a doctor

Primary outcomes:
measure: Number of patient who came to Nancy's pediatric emergencies during the study period
timeFrame: from 18 March to 30 June 2019 and 2020
measure: Reason of consultation during the study period
timeFrame: from 18 March to 30 June 2019 and 2020
Secondary outcomes:
measure: Number of children who was send by a General practician
timeFrame: from 18 March to 30 June 2019 and 2020
measure: Medical reason to be sending by a General practician
timeFrame: from 18 March to 30 June 2019 and 2020
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy's Pediatric Emergencies
state: Lorraine
Study officials:
References:
Clinical trial NCT05946837: Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device
Official title: Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neck Pain
Back Pain
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Eva MedTech, Inc.
First posted: 2023-07-14
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to objectively assess lymphatic function before, during, and immediately after Neuroglide treatment in lower trunk and leg lymphatic vessels, torso, axillary regions, inguinal regions, upper extremities, and cervical/neck and to determine any VAS (Visual Analog Scale, a commonly used measure of pain perception) score change after Neuroglide treatment.


Eligibility criteria: Inclusion Criteria:

* ambulatory and possess all four limbs
* Female participants of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration
* Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month following each imaging session in the study
* Weight less than 400 lbs

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Persons who are allergic to iodine or indocyanine green
* Heart failure, poorly controlled kidney disease (glomerular filtration rate \<30 mls per minute), hypoproteinemia, pulmonary hypertension, or hypothyroidism
* Any circumstance where increased lymphatic or venous return is undesirable

Primary outcomes:
measure: Change in frequency of lymphatic pulsing as assessed by the number of lymphatic pulses per minute in each region imaged
timeFrame: Baseline, during Neuroglide treatment ( 1 hour after NIRF-LI imaging ), 1 hour after PCT treatment
Secondary outcomes:
measure: Change in pain as assessed by the Visual Analog Scale (VAS)
timeFrame: Baseline, 1 hour after PCT treatment, 4-8 weeks after imaging for data analysis completion
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Melissa B Aldrich, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03383315: Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients
Official title: Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients: A Randomised, Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trauma
Opioid Analgesic Adverse Reaction
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized into two groups. One group receives tramadol and metoclopramide, while another group receives tramadol and placebo (normal saline).
Primary purpose: PREVENTION

Brief summary: Tramadol is widely used as analgesic in trauma patients. However, it causes side effects, most notably nausea and vomiting. This study aim to determine the role of prophylactic metoclopramide in preventing tramadol induced nausea and vomiting.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older on day of presentation to ETD SGH
* Sustained from traumatic injuries of extremities (Fracture of hand \& wrist, radius, ulna, humerus, femur, tibia, fibula and/or foot \& ankle; laceration wounds of extremities; soft tissue injury)
* Patient who is able to give consent

Exclusion Criteria:

* Known allergy to metoclopramide
* Concurrently taking medication with anti-emetic effect, including antihistamines, phenothiazines and dopamine antagonists.
* A history of vomiting since time of injury
* Patients who had already received tramadol or metoclopramide in the previous 8 hours prior to arrival at ETD
* Below age of 18 on day of presentation, or patients who could not consent to the study
* Any alteration in level of consciousness
* Hemodynamic instability or primary diagnosis requiring time critical intervention
* Pregnancy or lactation
* History or known case of vertiginous disorder
* Currently undergoing chemotherapy or radiotherapy

Primary outcomes:
measure: Nausea severity scale
timeFrame: One hour
Secondary outcomes:
measure: Vomiting
timeFrame: One hour
Other outcomes:
Locations:
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
Study officials:
References:
Clinical trial NCT05321615: Feasibility and Safety of a Wireless Palpator
Official title: A Prospective Study to Assess the Feasibility and Safety of a Wireless Palpator to Detect Occult Subpleural Lung Tumours in Humans During Minimally Invasive (VATS) Lung Resection.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer
Thoracic Neoplasm
Keywords: Palpation
Tactile image sensor
Lung ultrasound
VATS procedures
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of the ability of the Palpator to detect hidden (occult) lung tumours that cannot be visualized or palpated using the traditional methods of visual inspection, grasper palpation, and VATS ultrasound.

Detailed description: All procedures will be performed with the patient under general anesthesia with single lung ventilation through double-lumen endotracheal intubation. Three to four thoracoports, no larger than 12 mm, will be inserted in the intercostal spaces as needed. After VATS port placement, the pleural cavity will be insufflated with CO2 to a maximum pressure of 8 mm Hg to assist with lung deflation. A standard VATS pleuroscopy will be performed to visually search for the nodule and its position confirmed with sequential assessment using a grasper, the Palpator, the VATS ultrasound probe, and then finger palpation. This will ensure that all patients will have the opportunity to avoid a large thoracotomy if the lesion can't be identified by the Palpator. If the lesion can be detected either visually or by grasper palpation, this information will be recorded, but will be excluded from the analysis of Palpator feasibility.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Peripheral occult sub-pleural (\>5 mm) solitary lung nodule \< 50 mm on CT scan scheduled for surgical removal using a VATS approach

Exclusion Criteria:

* Semi-solid nodules (ground glass nodule).
* Pregnancy or potentially pregnant women.
* Mentally challenged.
* Inability to consent for the study.
* Patients less than 18 years old.
* Patients with pulmonary nodules easily located during VATS (\> 50 mm, pleural puckering, invading chest wall)
* Patients who have chest anatomy precluding VATS resection.

Primary outcomes:
measure: Tumour detection
timeFrame: 1 day
Secondary outcomes:
measure: Prevention of thoracotomy
timeFrame: 1 day
measure: Adverse events
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00827515: Relative Bioavailability and Food Effect Study
Official title: A Phase 1, Randomized, Open-Label, Single Dose, 4-Way Crossover Study In Healthy Volunteers To Assess The Relative Bioavailability Of The Oral Powder In Capsule (PIC) And An Immediate Release (IR) Film-Coated Tablet Of PH-797804 In The Fed And Fasted State
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Pain
Keywords: Relative Bioavailability Effect of food
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Initial studies have used a powder in capsule formulation of PH797804. In future studies an immediate release tablet will be used. The purpose of this study is to compare blood levels of PH797804 following an oral dose of the powder in capsule formulation and the tablet formulation. In addition the effect of food blood levels of PH797804 will be investigated


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects aged 21 to 55 years
* Healthy is defined as no clinical relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests
* Willing to use acceptable methods of contraception as outlined in the study protocol
* Body mass index between 18 to 30 kg/m2
* Subjects who are willing and able to comply with the scheduled visits, treatment plan and other study procedures

Exclusion Criteria:

* Subjects with evidence or history of clinically significant disease
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to the first dose until day 15 of period 4
* Subjects with conditions possibly affecting drug absorption (eg gastrectomy)
* A positive approved immunoassay/ELISA blood test for TB
* Subjects with a history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men
* Subjects who have use prescription or nonprescription drugs, vitamins and/or dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
* Subjects who have been administered medications capable of inducing hepatic enzyme metabolism (eg barbiturates, rifampin, carbamazepine, phenytoin or primidone) within 14 days (or 5 half-lives of the inducing agent, whichever is longer) of day 1 or within 28 days of administration of St John's wort

Primary outcomes:
measure: Blood levels of PH797804 up to 336 hours after dosing in each treatment period
timeFrame: 336 hours
Secondary outcomes:
measure: Safety and tolerability of PH797804 in each treatment period up to 336 hours post-dose
timeFrame: 336 hours
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00915915: Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)
Official title: Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol and Either 1.05 or 2.1 mg Gestodene in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Ovulation Inhibition
Keywords: Female contraception
Ovulation inhibition
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-08
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers


Eligibility criteria: Inclusion Criteria:

* BMI: 18 BMI 30 kg/m²
* Healthy female volunteers
* Age 18-35 years (smoker not older than 30 years, inclusive)
* Ovulatory pre-treatment cycle, at least 3 month since delivery
* Abortion or lactation before the first screening examination
* Willingness to use non-hormonal methods of contraception during entire study

Exclusion Criteria:

* Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/artial thromboembolic disease
* Regular intake of medication other than OCs
* Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle

Primary outcomes:
measure: The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3
timeFrame: 4 months
Secondary outcomes:
measure: The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3
timeFrame: 4 months
measure: Course of gonadotropins (FSH, LH, P, E2)
timeFrame: 4 months
measure: Endometrial thickness and Follicle size
timeFrame: 4 months
measure: Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3
timeFrame: 4 Months
measure: Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3
timeFrame: 4 Months
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05163015: Impact of Oncogeriatric Consultation on Quality of Life of Patients Aged 75 and More With Cancer
Official title: Impact of Oncogeriatric Consultation on Quality of Life of Patients Aged 75 and More With Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Cancers
aged patients
oncogeriatric consultation
quality of life
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged of 75 and more with cancer

Brief summary: Among patients with cancer, 6 in 10 are over 65 years of age. In order to improve quality of life of aged cancer patients, the oncogeriatric consultation has been created. Oncogeriatric consultation aim to help oncologists determine the best solutions to combine therapy and quality of life. Factors influencing quality of life of cancer patients have been studied previously. However, these studies always focus on one specific cancer.

Detailed description: The aim of the study is to study factors associated with quality of life in patients aged 75 and more with cancer, notably the oncogeriatric consultation.

Eligibility criteria: Inclusion Criteria:

* male or female
* aged of 75 and more
* with cancer
* with indication of oncogeriatric consultation according G8
* agreeing to participate in the study

Exclusion Criteria:

-less than 75 years old

Primary outcomes:
measure: EORTC QLQ-C30
timeFrame: Day 0
measure: EORTC QLQ-C30
timeFrame: Day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Institut Godinot
state: Grand-Est
Study officials:
References:
Clinical trial NCT02868515: The Effect of Hot Cereal on Digestive Health in Children
Official title: A Clinical Trial to Assess the Effect of Hot Cereal on Digestive Health in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Measures of Digestive Health Post Consumption
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2016-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to examine the effects of 2 servings of hot cereal per day over 2 weeks on digestive health in children that typically eat low fiber diets.

Detailed description: Participant eligibility will be screened at visit 1. The study will be a single-arm intervention design. The study procedures will include a pre-study visit, a pre-intervention baseline data collection period, a 14 day intervention period, and an end of study visit.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 7-12 yrs.
* Low fiber eater (\<14 g/d)
* Accustomed to eating breakfast at home
* Demonstrates spoken and written English literacy
* Parent/or legal guardian has experience using a cell phone camera
* Parent/or legal guardian is capable of emailing and texting photos by using cell phone features that enable this such as the select and attach option
* Able to provide assent with parent and/or legal guardian after review of study protocol and procedures
* Parent and/or legal guardian will also be required to provide consent on behalf of the child after reviewing study protocol and procedures

Exclusion Criteria:

* Use of enemas, laxatives, proton pump inhibitors, or antibiotics within the past 3 months
* Use of fiber supplements such as fiber gummies (inulin/chicory root), or Metamucil or Citrucel
* Use of vitamin/mineral supplements, multivitamins, or herbal supplements.
* Participation in any other clinical trial up to 6 months before day 1 of participation in this study
* History of medical or surgical events that may significantly affect the study outcomes including diagnosed gastric or digestive diseases
* Not a regular breakfast eater at home
* High-fiber eater (\>14 g of fiber per day)
* Allergies to any of the ingredients in the test products
* Children taking medication that affects appetite (i.e. certain ADHD medications that depress appetite)

Primary outcomes:
measure: Self reported frequency scales to questionnaire regarding digestive regularity
timeFrame: 2 weeks
Secondary outcomes:
measure: Gastrointestinal tolerance
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paruzynski H, Korczak R, Wang Q, Slavin J. A Pilot and Feasibility Study of Oatmeal Consumption in Children to Assess Markers of Bowel Function. J Med Food. 2020 May;23(5):554-559. doi: 10.1089/jmf.2019.0158. Epub 2019 Oct 14.