louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06619613: A Study of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease
Official title: A Randomized, Double-blind, Placebo-controlled and Multiple Dose Escalation Phase Ib Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled and multiple dose escalation phase Ib study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in patients with Alzheimer's disease related mild cognitive impairment and mild Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Voluntarily participate and have the subject and their legal guardian jointly sign the Informed Consent Form.
* The age of the subjects is between 50 and 85 years old.
* BMI≥19kg/m2 and ≤32.5 kg/m2, weight ≥45 kg and ≤100 kg at screening or baseline.

Exclusion Criteria:

* Cognitive impairment of subjects due to other medical or neurological factors (other than AD)
* History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year
* With any mental illness that may interfere with the cognitive assessment of the subjects.
* With history of moderate or severe renal dysfunction.
* With Uncontrolled stable hypertension.
* With history of severe trauma or major surgery in the 6 months prior to the screening period, or planned surgery during the study.
* History of malignancy within 5 years prior to screening.

Primary outcomes:
measure: Adverse event
timeFrame: Up to Week 26
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China
Study officials:
affiliation: The First Affiliated Hospital of University of Science and Technology of China
name: Jiong Shi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06897813: A Phase I Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of WD-910 in Healthy Participants
Official title: A Phase I Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of WD-910 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Zhejiang Wenda Medical Technology Co., Ltd.
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This is a phase I, randomised, double-blind, placebo-controlled, 3-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of WD-910 in in Healthy Participants Detailed


Eligibility criteria: Inclusion Criteria:

* Aged 18 to 55 years (inclusive) at the time of informed consent.
* Body mass index (BMI) between 18 to 32 kg/m2 and male participant with body weight of ≥ 50.0 kg, female participant with body weight ≥ 45.0 kg

Exclusion Criteria:

* Any major surgery within 12 weeks prior to Day 1, or any planned surgery during the study.
* Poor pill swallowing ability

Primary outcomes:
measure: The incidence of adverse events (AEs)
timeFrame: A single-ascending dose (SAD) study ：up to 1week; multiple-ascending dose (MAD) study and food effect (FE) study : up to2weeks
measure: Number of participants with abnormal lab values
timeFrame: SAD ：up to 1week; MAD and FE : up to2weeks
measure: Single Ascending Dose Cohorts : Cmax
timeFrame: From Day1 to Day3
measure: Single Ascending Dose Cohorts : AUC0-∞
timeFrame: From Day1 to Day3
measure: Single Ascending Dose Cohorts : Tmax
timeFrame: From Day1 to Day3
measure: Single Ascending Dose Cohorts : t½
timeFrame: From Day1 to Day3
measure: Multiple Ascending Dose Cohorts: Cmax,ss
timeFrame: Day1 , Day10
measure: Multiple Ascending Dose Cohorts: Cmin,ss
timeFrame: Day1 , Day10
measure: Multiple Ascending Dose Cohorts: Cavg,ss
timeFrame: Day1 , Day10
measure: Multiple Ascending Dose Cohorts: Tmax,ss
timeFrame: Day1 , Day10
measure: Multiple Ascending Dose Cohorts: AUC0-τ
timeFrame: Day1 , Day10
measure: Multiple Ascending Dose Cohorts: t½,
timeFrame: Day1 , Day10
measure: Food Effect Cohorts: Cmax
timeFrame: From Day1 to Day4 ， From Day8 to Day11
measure: Food Effect Cohorts: Tmax
timeFrame: From Day1 to Day4 ， From Day8 to Day11
measure: Food Effect Cohorts: AUC0-t
timeFrame: From Day1 to Day4 ， From Day8 to Day11
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd
state: Victoria
Study officials:
References:
Clinical trial NCT00033813: KUL0401: An Open-label Pilot Study of Oxatomide in Steroid-Naive Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscular Dystrophy, Duchenne
Keywords: Duchenne
muscular
dystrophy
controlled clinical trial
CINRG
Lead sponsor: Cooperative International Neuromuscular Research Group
Sponsor class: NETWORK
First posted: 2002-04-11
Enrollment: 15
Sex: MALE
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will help to determine the safety and efficacy of the mast cell stabilizer Oxatomide as a treatment for Duchenne muscular dystrophy (DMD). Boys with DMD who are enrolled in this study will should not have taken steroids to treat DMD for at least twelve months, and should not have taken any nutritional supplements for at least three months. Subjects will complete a two screening visits within a one-week period, and if enrolled will then have their strength tested monthly for three months before beginning therapy with Oxatomide. Once Oxatomide therapy is started, participants will have their strength tested monthly for six months. Following the six month treatment period, participants will be given the option to remain on Oxatomide until the study is completed.


Eligibility criteria: Subject Inclusion Criteria

1. 5 to 10 years of age
2. ambulatory
3. diagnosis of DMD confirmed by at least one of the following:

   * Positive x-linked family history of DMD in older male relatives (onset by 5 years, wheelchair bound by 12 years), or;
   * Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical DMD, or;
   * Gene deletion test positive (missing one or more exons) in the central rod domain (exons 25-60) of dystrophin, where reading frame can be predicted as 'out of frame', and clinical picture consistent with typical DMD.
4. glucocorticosteroid-naive (i.e. has not been treated with prednisone or deflazacort within the past year)
5. Evidence of muscle weakness by MRC score or clinical functional evaluation
6. QMT biceps score variability no greater than 10% between screening visits

Subject Exclusion Criteria

1. Failure to achieve one or more of the inclusion criteria listed above
2. Inability to suitably cooperate with strength assessments
3. Symptomatic DMD carrier
4. Use of oxatomide (or other anti-histamine drugs) within the last 6 months for DMD or any other disease
5. Use of creatine monohydrate or glutamine within the last 6 months
6. Use of carnitine, Coenzyme Q10, other amino acids or any herbal medications within the last 3 months
7. History of symptomatic cardiomyopathy
8. History of impairment of hepatic function
9. History of significant concomitant illness or significant impairment of renal function.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
References:
Clinical trial NCT01199913: POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia
Official title: Incidence of Postoperative Cognitive Dysfunction in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia: A Randomized, Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 1. Postoperative Cognitive Dysfunction
Keywords: problems with thinking after surgery;
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients, male and female, 65 years or older scheduled for elective surgery requiring general anesthesia.

Brief summary: The use of desflurane in elderly subjects (\>65 years old) undergoing general anesthesia with endotracheal intubation will result in decreased POCD compared to sevoflurane if the patient's MAP is within 20% of the patient's baseline and the cerebral suppression state index stays within the moderately anesthetized range during general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Adult patients (\>65 years old)
* Scheduled for elective surgery requiring general anesthesia at LLUMC HSH
* Airway management expected to include endotracheal intubation
* Expected surgical duration 120 to 240 minutes

Exclusion Criteria:

* Pre-existing significant psychiatric disease or mental status changes
* Clinically significant cardiovascular, respiratory, hepatic, renal,neurological, psychiatric, or metabolic disease
* Patient's weighing \>50% ideal body weight

  * Men: Ideal Body Weight (in kilograms) = 50 + 2.3 kg per inch over 5 feet
  * Women: Ideal Body Weight (in kilograms) = 45.5 + 2.3kg per inch over 5 feet
* Patients who have undergone a general anesthetic within the past 7 days
* Patient refusal

Primary outcomes:
measure: POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia
timeFrame: Both groups will complete the MMSE at 1, 6, and 24 hours after the end of anesthesia or to disharge up to 7 days.
Secondary outcomes:
measure: Secondary outcome measures will include: 1) time to extubation, anesthetic complications (e.g. coughing during extubation), 2) time to readiness for discharge from PACU, 3) length of hospital stay, and 4) any postoperative complications.
timeFrame: 24 hours to 7 days
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
References:
citation: Meineke M, Applegate RL 2nd, Rasmussen T, Anderson D, Azer S, Mehdizadeh A, Kim A, Allard M. Cognitive dysfunction following desflurane versus sevoflurane general anesthesia in elderly patients: a randomized controlled trial. Med Gas Res. 2014 Mar 25;4(1):6. doi: 10.1186/2045-9912-4-6.
Clinical trial NCT05164913: Study of the Effect of General Anesthesia on Children's Behavior
Official title: A Retrospective Study of the Effect of General Anesthesia on Children's Behavior
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Behavior
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 1140
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children without basic behavioral abnormalities who have undergone surgery in this hospital

Brief summary: This topic speculates that there is an interaction between family environment and anesthetic drug exposure on children's behavior. Different family environments have different response to anesthetic drug exposure. Children living in a specific family environment may be more susceptible to the effects of anesthetic drugs. People who are susceptible to exposure to narcotic drugs. In order to clarify this hypothesis and discover specific family environment factors that interact with anesthetic drug exposure, this project intends to establish a retrospective cohort study, through hierarchical analysis and other means, to clarify the behavioral changes of children in different family environments after exposure to anesthetic drugs. Provide theoretical support for the safe application of clinical children's anesthetics.


Eligibility criteria: Inclusion Criteria:

* Children aged 0-5 who underwent surgery at Shanghai Ninth People's Hospital
* Current age is less than 18 years old
* No surgical complications such as acute infectious diseases, systemic diseases

Exclusion Criteria:

* History of neonatal hypoxic ischemic encephalopathy and bilirubin encephalopathy
* There are genetic diseases or chromosomal diseases, neurological diseases (including epilepsy, congenital diseases), or a history of head trauma, a history of central nervous system infectious diseases, high fever convulsions, congenital heart disease, tumor diseases, and Patients with blood diseases
* People who have autism, attention deficit hyperactivity disorder, or have received behavioral related treatments and interventions
* Those who have undergone cardiovascular surgery, neurosurgery, or those with unstable hemodynamics during surgery
* Those who cannot be contacted, refused to join the group, the questionnaire information does not match the medical records, or the complete medical records cannot be obtained

Primary outcomes:
measure: Achenbach Child Behavior Checklist （CBCL）scale
timeFrame: immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06715813: Additional Effects of Transversus Abdominial Strengthening Along With Pelvic Floor Muscle Strengthening on Stress Urinary Incontinence Among Multiparous Women
Official title: Additional Effects of Transversus Abdominial Strengthening Along With Pelvic Floor Muscle Strengthening on Stress Urinary Incontinence Among Multiparous Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial having two groups. One group will receive SNAGs and the second will receive Sternocleidomastoid Release along with SNAGS. Both groups will be recruited concurrently.
Primary purpose: TREATMENT

Brief summary: SUI stands for stress urinary incontinence. A common condition seen among multiparous women associated with physical strain like bending, coughing, sneezing that put strain on the pelvic floor muscles.


Eligibility criteria: Inclusion Criteria:

* Age group: multiparous women ( 30-50 yrs)
* females only
* all modes of delivery of childbirth
* diagnosed cases of SUI from fauji foundation hospital.
* patient without any medical contraindications and limitations (Sign and Symptoms of SUI)
* accordances with the michigan incontinence index

Exclusion Criteria:

* pregnancy or recent childbirth
* any history of pelvic organ prolapse or surgical intervention
* metabolic diseases, uncontrolled hypertension as well as neurological intervention
* any kind of malignancy in lower abdomen

Primary outcomes:
measure: stress urinary incontinence
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References:
Clinical trial NCT03156413: The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea
Official title: The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2017-05-17
Enrollment: 12
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: This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.

Detailed description: A maximum of 12 OSA participants who currently use a nasal mask will be recruited for the trial. Participant will be on the trial for 1 night (in-lab)

Eligibility criteria: Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
* Prescribed PAP for OSA
* Existing nasal mask user

Exclusion Criteria:

* Inability to give consent
* Patients who are in a coma or a decreased level of consciousness
* Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency
* Current diagnosis of carbon dioxide (CO2) retention
* Pregnant or may think they are pregnant

Primary outcomes:
measure: Ease of use
timeFrame: 1 night
measure: Acceptability
timeFrame: 1 night
Secondary outcomes:
measure: Objective leak data
timeFrame: 1 night
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher and Paykel Healthcare
Study officials:
affiliation: Sponsor Employee
name: Sarah Gunson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00995813: Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure
Official title: Pilot Study of the Safety and Immunogenicity of the Rotavirus Vaccine in Infants With Intestinal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intestinal Failure
Rotavirus Vaccines
Keywords: Intestinal failure
Rotavirus vaccine
Infants
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
name: National Center for Research Resources (NCRR)
First posted: 2009-10-15
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety and immune response of the rotavirus vaccine in infants who have undergone abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Infants with one of the following diagnoses:

  * necrotizing enterocolitis requiring operation;
  * congenital atresia of the intestine;
  * gastroschisis;
  * midgut volvulus requiring bowel resection; or
  * long-segment intestinal aganglionosis
* Minimum gestational age of 35 weeks at time of first vaccine dose

Exclusion Criteria:

* immunocompromise secondary to HIV infection or immunodeficiency state
* active use of corticosteroid or other immunosuppressive agents
* active infection as defined by fever \> 38°C within 24 hours, positive blood culture within 7 days, or positive urine culture within 3 days of enrollment
* severe malnutrition as defined by serum albumin \< 2.0 mg/dL or serum prealbumin \< 6 mg/dL.

Primary outcomes:
measure: The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable.
timeFrame: 1-12 weeks following vaccine administration
Secondary outcomes:
measure: The secondary outcome measure is the preliminary measurement of the immunogenicity of the rotavirus vaccine in infants with intestinal failure.
timeFrame: 1-12 weeks following vaccine administration
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital and The University of Washington
name: Patrick J Javid, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital and The University of Washington
name: Simon Horslen, M.B., ChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital and The University of Washington
name: Janet Englund, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02258113: Measuring of Neuro-visual Functionality With Ocusweep
Official title: Measuring of Neuro-visual Functionality With New Human Visual System Device Ocusweep
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Visual Impairment
Lead sponsor: Ocuspecto Oy
Sponsor class: INDUSTRY
First posted: 2014-10-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to measure visual acuity, contrast sensitivity and visual field by SAP-method using a novel device Ocusweep compared to currently widely used methods. Addition to that, the aim is to validate a novel perimetry method (Visual Search Test, VST) which is based on reaction times in visual decision- making task, where the subject is allowed to move eyes and where the fixation is verified by the subject himself in contrast to standard automatic perimetry (SAP) where prolonged stationary fixation and external fixation monitoring apparatus is required. Reaction-time based visual field device Ocusweep is compared to generally used SAP methods. Those tests will be done for healthy volunteers and for persons with diagnosed eye or brain disease.

Ocusweep OcuRT vision based choice reaction time test is validated for test repeatability and compared to Trail Making Test (TMT), Useful Field of View (UFOV) and Vienna Test System (VTS) reaction time tests. To evaluate the ability to detect unreliable results, OcuRT test is also done under cognitive load and with instructions to cheat the test.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Persons suffering diagnosed eye disease
* Persons suffering diagnosed brain disease

Exclusion Criteria:

* No diabetes
* Only one diagnosed disease

Primary outcomes:
measure: Visual acuity
timeFrame: One visit per one patient (1h/visit)
Secondary outcomes:
measure: Contrast sensitivity
timeFrame: One visit per one patient (1h/visit)
measure: Reaction time visual field
timeFrame: One visit per one patient (1h/visit)
measure: Vision based choice reaction time
timeFrame: One visit per one test subject (1h/visit)
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Ocuspecto Oy
Study officials:
References: