louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04169191: Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia
Official title: Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia: An Open-label Dose-finding Clinical Trial (Phase Ib Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Birth Asphyxia
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 3+3 design to escalate the sildenafil dose up to 6 mg/kg/day (3mg/kg/dose q12h)
Primary purpose: TREATMENT

Brief summary: The investigators will determine the maximum tolerable dose of sildenafil and establish the pharmacokinetic and pharmacodynamic profile of sildenafil in human asphyxiated neonates treated with hypothermia. They will use a 3+3 design to escalate the sildenafil dose up to 6 mg/kg/day (3mg/kg/dose q12h) in asphyxiated neonates demonstrating brain injury despite hypothermia treatment and assess whether we observe any beneficial effects of sildenafil on their brain and cardiopulmonary hemodynamics, without causing serious adverse events


Eligibility criteria: Inclusion Criteria:

* Male and female neonates meeting the criteria for induced hypothermia:

  * Gestational age ≥ 36 weeks and birth weight ≥ 1800 g;
  * Evidence of fetal distress, i.e., history of an acute perinatal event, cord pH ≤ 7.0 or base deficit ≤ - 16 mEq/L;
  * Evidence of neonatal distress, such as an Apgar score ≤ 5 at 10 minutes, postnatal blood gas pH obtained within the first hour of life ≤ 7.0 or base deficit ≤ - 16 mEq/L, or a continued need for ventilation initiated at birth and continued for at least 10 minutes;
  * Evidence of moderate to severe neonatal encephalopathy by an abnormal neurological exam and/or an amplitude-integrated electroencephalogram (aEEG).
* Evidence of brain injury on a brain magnetic resonance imaging (MRI) performed on day 2 of life.

Exclusion Criteria:

* Neonates with complex congenital heart disease
* Neonates with cerebral malformations
* Neonates with genetic syndrome
* Neonates with intraventricular and/or intraparenchymal hemorrhage on MRI performed on day 2 of life

Primary outcomes:
measure: Death
timeFrame: within first 10 days of life
measure: Hypotension
timeFrame: within first 10 days of life
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: within first 10 days of life
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT01587391: Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 163538 XX
Official title: A Randomised, Double-blind, Placebo-controlled Trial in Healthy Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 2.5 mg to 160 mg of BI 163538 XX
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-04-30
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 163538 XX within a predefined dose range


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects
2. overweight or obese

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: up to 15 days postdose
Secondary outcomes:
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: up to 96 hours postdose
measure: AUC0-∞ (area under the concentration-time curve of the in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 96 hours postdose
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
timeFrame: up to 96 hours postdose
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: 1291.1.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT06619691: HOFOT Fine Motor Program
Official title: Hands on Fun Occupational Therapy Fine Motor Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fine Motor Skills
Keywords: Preschool
fine motor program
fine motor skills
early childhood development
Lead sponsor: Mercy University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine if an 8 week fine motor intervention program will lead to improve fine motor skills as measured by a standardized assessment (PDMS-3) in pre- and post-test.

Detailed description: The aim of this study is to determine if an 8 week fine motor intervention program will lead to improve fine motor skills as measured by a standardized assessment (Peabody Developmental Motor Scale, 3rd edition) in pre- and post-test. The hypothesis is that a daily fine motor program will improve overall fine motor skills within 8 weeks.

Eligibility criteria: Inclusion Criteria:

* preschooler aged 3-5 years old enrolled in local preschool

Exclusion Criteria:

* None other than denial of parent consent or lack of child assent

Primary outcomes:
measure: Peabody Developmental Motor Scale, 3rd Edition
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dobbs Ferry
country: United States
facility: Mercy University
state: New York
Study officials:
References:
Clinical trial NCT02951091: Biomarker-Integrated Umbrella, Advanced Gastric Cancer
Official title: The Master Protocol for Biomarker-Integrated Umbrella Trial in Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Biomarker-integrated multi-arm with shared standard of care (SOC) control arm
Primary purpose: DIAGNOSTIC

Brief summary: In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment.

The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.

Detailed description: In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment.The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
2. Eastern Cooperative Oncology Group performance status of 0 to 1
3. Male or female; ≥ 19 years of age
4. On or progression after 1st line palliative chemotherapy
5. Subjects with evaluable lesion (using RECIST 1.1 criteria)
6. Subjects who meet the following criteria:

   * Absolute neutrophil count ≥ 1000 /µL
   * Platelet count ≥ 75,000/ µL
   * Serum creatinine \< 1.5 x upper limit of normal or Creatinine clearance ≥60 mL/min
   * aspartate aminotransferase and alanine transaminase 3 x upper limit of normal

Exclusion Criteria:

* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Primary outcomes:
measure: progression free survival
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System, Yonsei Cancer Center
Study officials:
affiliation: Severance Hospital
name: Sun Young Rha, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02005991: A Study To Examine The Distribution Of PF-05212377 In The Brain Of Healthy Volunteer Subjects Using Positron Emission Tomography And A Radioactive Tracer Following Oral Administration Of One Dose Of PF-05212377
Official title: A Phase 1, Open-Label Study To Evaluate 5-HT2a Receptor Occupancy As Measured By Positron Emission Tomography (PET) With Ligand [11C]MDL100907 Following Single Oral Dose Administration Of PP-05212377 (SAM-760) In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PF-05212377
phase 1
open-label
5-HT2a receptor occupancy
positron emission tomography
healthy subjects
brain
cortex
alzheimers disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will see how PF-05212377, an experimental drug to treat symptoms from Alzheimer's Disease, distributes in the brain after one dose of PF-05212377 is administered orally to healthy volunteer subjects. The study will also evaluate the safety and tolerability of PF-05212377 in these subjects and will measure the level of PF-05212377 in the blood.


Eligibility criteria: Inclusion Criteria:

* Males and females must be at least 18 years of age and no older than 55 years of age with a Body Mass Index (BMI) must be between 17.5 and 30.5.
* Subjects must sign a consent form and comply with all scheduled visits, treatment plan, lab tests and other study procedures.

Exclusion Criteria:

* Females must not be pregnant, breastfeeding, or able to have children.
* Subjects must not have a severe acute or chronic medical or psychiatric condition history or evidence of blood, kidney, glandular, lung, stomach, intestine, heart, blood vessel, liver, psychiatric, nerve, or allergic problems (including drug allergies), except mild seasonal allergies.
* Subjects must not drink alcohol excessively or take illicit drugs.
* Male subjects use condoms to prevent the potential transfer of drug through the semen to their partner beginning with the dose of study drug and use a highly effective method of birth control with any partner(s) of childbearing potential through 28 days after the last dose.

Primary outcomes:
measure: 5-HT2a receptor occupancy of PF-05212377 in the frontal cortex using PET
timeFrame: Days 1 and 2
measure: Plasma PF-05212377 exposure associated with PF-05212377 5-HT2a receptor occupancy
timeFrame: Days 1 and 2
Secondary outcomes:
measure: 5-HT2a receptor occupancy of PF-05212377 in other cortical regions
timeFrame: Day 1 and 2
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05566691: Strategies for Coping With Negative Thoughts
Official title: Strategies for Coping With Negative Thoughts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Negative Thinking
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the impact of two strategies for coping with negative automatic thoughts (positive thinking and cognitive restructuring) on one's belief in negative thoughts and one's affect. Another main objective is to assess whether participating in a positive mood induction (versus no mood induction) prior to using one of the two coping strategies impacts belief in negative thoughts and affect. We will also explore the interaction between strategy condition and mood induction condition. As secondary outcomes, we will evaluate whether there are changes in positive thinking skills and cognitive restructuring skills and depressive symptoms after one week of using the strategy.

Detailed description: Participants will be randomized to learn about positive thinking or cognitive restructuring, which will involve watching brief videos, being presented with examples of how one might apply the strategy when experiencing negative thoughts, and practicing with a personal example using a worksheet. Participants will also be randomized to positive mood induction, which is comprised of an autobiographical recall exercise in which participants are asked to recall a pleasant memory before filling out the worksheet. Participants will be asked to use the strategy and complete a worksheet online once per day for six days. Participants will respond to questionnaires at baseline and after 6 days of strategy use.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older.

Exclusion Criteria:

* A level of visual impairment that would prevent them from being able to answer questions on an electronic screen.

Primary outcomes:
measure: Change in Positive and Negative Affect Schedule
timeFrame: Assessed at baseline, each day for 6 days, and one week post-baseline.
measure: Change in belief in negative thought
timeFrame: Assessed at baseline, each day for 6 days, and one week post-baseline.
measure: Change in mood
timeFrame: Assessed at baseline, each day for 6 days, and one week post-baseline.
Secondary outcomes:
measure: Change in positive thinking and cognitive restructuring skills
timeFrame: Assessed at baseline and one week post-baseline.
measure: Change in Quick Inventory of Depressive Symptoms Self-Report
timeFrame: Assessed at baseline and one week post-baseline.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References:
Clinical trial NCT04249791: Laparoscopic-robotic Hysterectomy for Uterine Transplantation in Live-donor Patient.
Official title: Feasibility Assessment of Assisted Laparoscopic-robotic Hysterectomy for Uterine Transplantation in Live-donor Patient. Description of the Donor and Recipient Surgical Technique.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Anomaly
Keywords: uterine transplant
robotic surgery
donor
recipient
uterine anomaly
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2020-01-31
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Currently, there is no standard and indicated standard access route for uterine removal in the uterine transplant donor patient. The aim of the study is to show the feasibility of performing this procedure by replicating in our center the results found in other recent studies and to try to reduce the surgery time for both the donor and recipient patients.

Detailed description: Few cases have been performed worldwide by laparotomic and, more recently, laparoscopic and assisted robotic access pathways. This is a clinical trial with 6 participants (3 donors and 3 recipients) to investigate the feasibility of an assisted laparoscopic-robotic surgical access route for uterine removal in the donor patient in uterine transplants. In the receiving patient, conventional surgery (midline incision) will be performed for uterine transplantation and vascular anastomoses.

Eligibility criteria: Inclusion Criteria:

* Desire for uterine transplantation as a donor of the uterus (with family relationship with the donor patient);
* At least one pregnancy before

Exclusion Criteria:

* comorbidities that contraindicate a surgical procedure
* Women who do not understand the study;
* Women subject to the regime that determines significant vulnerability to the participant (eg prisoners, indigenous, etc.)
* ABO blood test mismatch between donor and recipient patient.

Primary outcomes:
measure: transplant sucess rate
timeFrame: 2 years after transplantation
Secondary outcomes:
measure: Live births after uterus transplantion
timeFrame: 2 years after transplantation
measure: Pregnancy rate
timeFrame: 2 years after transplantation
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: São Paulo
Study officials:
affiliation: Barretos Cancer Hospital
name: MARCELO DE A VIEIRA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vieira MA, Souza C, Nobrega L, Reis R, Andrade C, Schmidt R, Carvalho L. Uterine Transplantation with Robot-assisted Uterus Retrieval from Living Donor: First Case in Brazil. J Minim Invasive Gynecol. 2021 Nov;28(11):1817. doi: 10.1016/j.jmig.2021.08.028. Epub 2021 Sep 4.
Clinical trial NCT02164591: Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis
Official title: Escalating Temporary Gastric Electrical Stimulation for Severe Gastroparesis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gastroparesis
Keywords: gastroparesis
gastric electrical stimulator
GES
vomiting
nausea
bloating
postprandial fullness
epigastric pain
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have been diagnosed with gatroparesis.

Brief summary: The purpose of this study is to determine the physiologic effects of temporary gastric electrical stimulation in subjects with severe gastroparesis.

Detailed description: This study will look to determine the clinical benefit placing temporary gastric electrical stimulation, the ability to predict the clinical response to surgical implantation of GES, and the feasibility and patient tolerability of endoscopic placement of temporary Gastric Electrical Stimulator (t-GES),

Eligibility criteria: Inclusion Criteria:

* At least 3 months of gastroparesis-related symptoms, such as nausea, emesis, and/or retching
* Solid phase 4-hr gastric scintigraphy is consistent with gastroparesis within 3 months of study enrollment\*

  * retention at 2 hr: \>60% or
  * retention at 4 hr: \>10% \*Based on International consensus on gastric scintigraphy

Exclusion Criteria:

* Gastric outlet, small bowel, or colon obstruction.
* Small bowel malrotation
* Inflammatory bowel disease
* Contraindication for surgical implantation of GES
* Presence of illness that may require MRI during the study; such as pituitary tumor, herniated disc, spinal stenosis, multiple sclerosis, etc.
* Significant comorbidity due to sever cardiovascular, renal, pulmonary, or liver disease.
* Significant coagulopathy
* Non-ambulatory patients: bed-ridden, nursing home resident, etc.
* Pregnancy
* Unable to give own informed consent
* Prisoners

Primary outcomes:
measure: Improvement in the symptoms of gastroparesis by t-GES in patients with severe gastroparesis.
timeFrame: 1 month
Secondary outcomes:
measure: Clinical response to t-GES placement as measured by questionnaires
timeFrame: 1 year
measure: Develop a prospective registry in patients undergoing escalating t-GES
timeFrame: 1 year
measure: determine the feasibility and patient tolerability of endoscopic placement of t-GES
timeFrame: 1 year
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hosptial
state: Indiana
Study officials:
affiliation: Indiana University
name: John M Wo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03746691: Effect of Citalopram on Reflux Episodes in Healthy Volunteers
Official title: Effect of Citalopram on Fasting and Postprandial Lower Esophageal Sphincter Function in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastro Esophageal Reflux
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Citalopram is sometimes used in the treatment for gastro-esophageal reflux disease, however, there are no empirical data to support this. The investigators would like to know if citalopram has an effect on the lower esophageal sphincter pressure, transient lower esophageal sphincter relaxations and reflux episodes. The investigators will investigate this by performing high resolution impedance manometry in healthy volunteers before and after a solid meal. This will be compared to placebo, in a cross-over, randomized, double-blind condition.


Eligibility criteria: Inclusion Criteria:

* between 18 and 65 years

Exclusion Criteria:

* history of upper GI symptoms
* history of upper GI surgery
* psychological disorders
* any drug history
* use of medication altering GI motility
* nursing and pregnant woman

Primary outcomes:
measure: Change in LES pressure
timeFrame: LES pressure will be measured for 4 times (a 5 sec time window) per hour. The average of the first hour will be taken as the LES pressure for the first hour postprandially.
measure: Change in the number of reflux episodes
timeFrame: The number of reflux episodes will be counted in a 3 hour time period, to have 1 number of reflux episodes.
measure: Change in the number of TLESRs
timeFrame: The total number of TLESRs will be counted in a 3 hour time period, to have 1 number of TLESRs.
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jan Tack, Prof.
role: PRINCIPAL_INVESTIGATOR
References: