louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04958317: Night Time Walking to Improve Glycaemic Control in Healthy Adults
Official title: The Effect of Exercise Timing on Postprandial Glycaemic Control: a Randomised Crossover Trial in Healthy Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postprandial Hyperglycemia
Insulin Resistance
Keywords: glucose tolerance
meal timing
insulin
postprandial
walking
Lead sponsor: Monash University
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 0
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: PREVENTION

Brief summary: Randomised crossover trial to compare early vs late walking on postprandial glycaemic response at night time.

Detailed description: In this crossover trial, eligible participants will be randomised to a 30-minute bout of physical activity (30 minute walk) either during the day or after an evening meal. The postprandial response to the evening meal will be analysed.

Eligibility criteria: Inclusion criteria

* Men and Women aged 18 to 65 years of age
* Waist circumference of \<94cm and \<80cm for Caucasian males and females, respectively
* Waist circumference of \<90cm and \<80 cm for Asian males and females, respectively
* Willingness to provide written informed consent and willingness to participate and comply with the study

Exclusion criteria

* Current or recent treatment (within 6 months) with medications that influence blood glucose
* Fasting blood glucose ≥ 7 mmol/L
* Individuals diagnosed with type 1 or type 2 diabetes mellitus, chronic gastrointestinal disorders (including inflammatory bowel disease and celiac) or any other condition deemed unstable
* Serious health conditions that may affect participation e.g. liver or thyroid dysfunction, recent major surgery
* Not able to walk for 30 mins at 5-5.5 km/hr
* Women planning pregnancy, pregnant or lactating.

Primary outcomes:
measure: Postprandial glucose
timeFrame: Three hour glucose iAUC will be calculated at nine time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 mins) after beginning consumption of the test meal.
Secondary outcomes:
measure: Postprandial insulin
timeFrame: Three hour insulin iAUC will be calculated at six time points (0, 30, 60, 90, 120 and 180 mins) after beginning consumption of the test meal.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04007224: Umbilical Cord Blood vs Personalized Treatments for Improving Autistic Disorder
Official title: Comparison of Umbilical Cord Blood vs Personalized Treatment for Improving Autistic Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autistic Spectrum Disorder
Lead sponsor: Fundatia Bio-Forum
Sponsor class: OTHER
Collaborators: name: Spitalul Angiomedica
First posted: 2019-07-05
Enrollment: 35
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical study evaluates in an open-label, crossover design the comparative efficacy and safety of intranasal oxytocin and autologous umbilical cord blood for improving the functioning of children with autistic spectrum disorder

Detailed description: Children aged 3-7 years diagnosed with autistic spectrum disorder and who did not previously receive oxytocin or umbilical cord blood treatments, will be enrolled to receive both treatments in random order. Assessment of functioning impairment will be done with QCHAT/M-CHAT/CAST questionnaires initially, at 2 months, 6 months and 1 year after first treatments. Either oxytocin or cord blood will be administered initially and at visit 2, which will take place at 2 months. All children will receive both treatments. A total of 25-40 children are expected to enroll and complete the study.

Eligibility criteria: Inclusion Criteria:

* diagnosis of autistic spectrum disorder

Exclusion Criteria:

* metabolic or genetic disorder (ex storage disease, Down, etc),

Primary outcomes:
measure: Improvement in behaviour, interaction with family and peers
timeFrame: At 2 months after administration of either treatment
measure: Improvement in behavior and social interaction
timeFrame: At 2 months after administration of either treatment
measure: Improvement in overall functioning of the child
timeFrame: At 2 months after administration of either treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Spitalul Angiomedica
state: Bucuresti
city: Bucharest
country: Romania
facility: Medicover Hospital
Study officials:
affiliation: Fundatia Bio-Forum
name: Felician Stancioiu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stancioiu F, Bogdan R, Bulumac B, Ivanescu B, Dumitrescu R. Decontamination of Two Umbilical Cord Blood Grafts Prior to Autologous Administration. Maedica (Bucur). 2022 Dec;17(4):885-892. doi: 10.26574/maedica.2022.17.4.885.
Clinical trial NCT06069024: Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide
Official title: Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Myelodysplastic Syndromes
Lymphoma
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with different diagnosis are eligible if they were above the age of 18 and received lenalidomide treatment.

Brief summary: This is a non-intervention, prospective, open-label and observational clinical trial. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study was to establish a population pharmacokinetic(PPK) model of lenalidomide and explore factors associated with the adverse events of lenalidomide from a pharmacokinetic(PK) perspective.

Detailed description: Studies have found that there is significant interpatient variability in the plasma concentration of lenalidomide, and the PK parameters of lenalidomide do not affect its efficacy but may be correlated with its toxicity. Therefore, the investigators plan to conduct a PPK study on lenalidomide to identify factors contributing to interpatient PK differences, thus refining regimens to mitigate its adverse reactions, in the hope of optimizing the clinical application of lenalidomide. At least 50 patients are planned to be included. It should be noted that the study does not interfere with the patients' treatment plans. Except for the discomfort during blood sampling, patients will not be exposed to any risks.

Eligibility criteria: Inclusion Criteria:

* Patients who are above the age of 18
* Patients who receive lenalidomide treatment

Exclusion Criteria:

* Patients have received other investigational systemic drugs
* The clinical data are deemed insufficient
* There appear other factors that rendered them ineligible.

Primary outcomes:
measure: drug blood concentration
timeFrame: 2 years
measure: genotype
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: the First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
References:
Clinical trial NCT04392024: Clinical Outcome of Extended-depth-of-focus Trifocal Intraocualr Lens (Triumf) Implantation
Official title: Clinical Outcome of Extended-depth-of-focus Trifocal Intraocualr Lens (Triumf) Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Depth and focus
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical outcome of extended-depth-of-focus trifocal intraocualr lens (Triumf) implantation


Eligibility criteria: Inclusion Criteria:

1. Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye
2. Age-related cataract
3. A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
4. A patient want presbyopia correction at the same time as cataract surgery
5. A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
6. Written informed consent to surgery and participation in the study

Exclusion Criteria:

1. Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract
2. Pregnant woman and lactating woman
3. A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
4. A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye
5. If expectations for presbyopia correction are too high
6. Those who are not able to read and understand the informed consent (illiterate or foreigners)

Primary outcomes:
measure: Uncorrected distant visual acuity
timeFrame: 3 months
measure: Uncorrected near visual acuity
timeFrame: 3 months
Secondary outcomes:
measure: Contrast sensitivity
timeFrame: 3 months
measure: Quality of Vision
timeFrame: 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Tae-Young Chung, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04276324: Effects of Ten-Weeks Power Training on Neuromuscular Performance, Heart Rate Variability, Sleep Quality and Mobility in Persons With Multiple Sclerosis
Official title: Effects of Ten-Weeks Resistance Training on Neuromuscular Performance, Heart Rate Variability, Sleep Quality and Mobility in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease of the central nervous system, characterized by demyelination due to inflammation and degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter, brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems. Strength training has been shown to improve strength and mobility in persons with MS.


Eligibility criteria: Inclusion Criteria:

* mild or moderate disability with clinical mild spastic-ataxic gait disorder.
* stable phase of the disease.

Exclusion Criteria:

* Expanded Disability Status Scale (EDSS) \< 6.
* relapsing disease within the preceding 12 months.
* corticosteroid treatment within the last months before study inclusion.

Primary outcomes:
measure: Maximal Voluntary Isometric Contraction of Knee Extension
timeFrame: Before the program training
measure: Maximal Voluntary Isometric Contraction of Knee Extension
timeFrame: After 10 weeks
measure: Rate of Force Development
timeFrame: Before the program training
measure: Rate of Force Development
timeFrame: After 10 weeks
measure: Central Activation Ratio
timeFrame: Before the program training
measure: Central Activation Ratio
timeFrame: After 10 weeks
measure: Spasticity
timeFrame: Before the program training
measure: Spasticity
timeFrame: After 10 weeks
Secondary outcomes:
measure: Walking speed
timeFrame: Before the program training
measure: Walking speed
timeFrame: After 10 weeks
measure: Static balance
timeFrame: Before the program training
measure: Static balance
timeFrame: After 10 weeks
measure: Functional capacity
timeFrame: Before the program training
measure: Functional capacity
timeFrame: After 10 weeks
measure: Heart Rate Variability
timeFrame: Before the program training
measure: Heart Rate Variability
timeFrame: After 10 weeks
measure: Sleep Quality
timeFrame: Before the program training
measure: Sleep Quality
timeFrame: After 10 weeks
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio
Study officials:
affiliation: Universidad Católica San Antonio de Murcia
name: Jacobo Á Rubio-Arias, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05051124: Peers and Technology for Adherence, Access, Accountability, and Analytics
Official title: PT4A (Peers and Technology for Adherence, Access, Accountability, and Analytics) - A Qualitative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Medication Adherence
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-09-21
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall objective of this project is to utilize the PRECEDE-PROCEED framework to conduct transdisciplinary, translational implementation research focused on improving medication adherence for hypertension control. The central hypothesis is that peer delivery of medications integrated with HIT (PT4A) will be effective in improving hypertension medication adherence, contributing to improved blood pressure among patients with uncontrolled hypertension in western Kenya. This study record will focus on Sub-Aim 2.2: a pilot of the intervention and a survey questionnaire with patients, peers, and clinical staff to evaluate feasibility. The investigators will evaluate impact on systolic blood pressure, medication adherence, and fidelity of implementation. The investigators will also create a retrospective comparator (control) group of CDM patients, through querying AMRS, matched by sex, age, location and initial blood pressure level. The investigators will then use their recorded blood pressure over a comparable period of up to 1 year and to allow for comparison to the blood pressure changes observed in the patients enrolled in the PT4A program to help understand the magnitude and variance of the intervention effects.


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years old
* Enrolled in the AMPATH CDM PRogram
* Have uncontrolled hypertension (defined as systolic blood pressures ≥ 140 or diastolic blood pressure ≥ 90)

Exclusion Criteria:

* Acute illness requiring immediate medical attention
* Terminal illness
* Inability to provide informed consent

Primary outcomes:
measure: Absolute Mean Change in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Month 12
measure: Pill Count Adherence Ratio
timeFrame: Month 12
measure: Number of Confirmed Medication Deliveries
timeFrame: Month 12
measure: Number of Peer Completions of HIT Form
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Rajesh Vedanthan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07016724: Neoadjuvant Radiochemotherapy Combined With Cadonilizumab for Local Advanced Esophageal Squamous Cell Cancer
Official title: Neoadjuvant Radiochemotherapy Combined With Cadonilizumab for Local Advanced Esophageal Squamous Cell Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Esophageal squamous cell cancer (ESCC) has a high incidence in China. Although the fast development of immune check point inhibitors (ICIs), the rate of pCR is limited with the mode of ICIs combined with neoadjuvant radiochemotherapy. The rate of pCR under ICIs combined with neoadjuvant radiochemotherapy was reported around 50%, which means more than half of those patients could not obtain pCR in reality. In order to explore a more effective mode of neoadjuvant therapy for ESCC, we designed this study to evaluate the effect of PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy in local advanced ESCC.


Eligibility criteria: Inclusion Criteria:

* diagnosed with esophageal squamous cell cancer;
* staged with cT1N+M0/cT2-3N0-3M0;
* experienced no cancer-related treatment;
* ECOG 0-1;
* Expected survival more than 6 months;
* aimed at neoadjuvant therapy for surger;
* have adquate organ function.

Exclusion Criteria:

* diagnosed with other types of cancer during last five years;
* have a tendency to bleed;
* accepted any type of cancer-related therapy.

Primary outcomes:
measure: pCR
timeFrame: perioperative
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: the First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Xiangbo Wan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06594224: Comparison of IV Nalbuphine Versus Ibuprofen for Postoperative Pain Control in Cesarean Section
Official title: Comparison of IV Nalbuphine Versus Ibuprofen for Postoperative Pain Control in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The local data is insufficient to directly compare IV nalbuphine versus ibuprofen among people in this region. The findings of this study would add to the existing data and would be helpful for health providers to opt for a better option for postoperative pain relief following a cesarean section under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Parturient females
* Aged between 18-45 years
* Gestational age above 32 weeks
* ASA class I to II
* Anticipated hospital stay for at least 24 hours

Exclusion Criteria:

* Known allergy to the drugs being evaluated in this study
* Renal and/or hepatic impairment (as per medical record)
* History of bronchial asthma or history or risk of intracranial hemorrhage (as per medical record)
* Low platelets count (\&lt;70000) or with bleeding diathesis
* BMI above 30 kg/m2

Primary outcomes:
measure: Efficacy in pain control
timeFrame: At 1 hour, 3 hours, and 6 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Nishtar Hospital
state: Punjab
city: Multan
country: Pakistan
facility: Nishtar Medical University
state: Punjab
Study officials:
affiliation: Department of Obstetric and Gynecology Nishtar Medical University, Multan
name: Mehnaz Khakwani, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetric and Gynecology Nishtar Medical University, Multan
name: Hajra Sultana, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04947124: A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101
Official title: Masked, Randomized, Single-site, Crossover Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 Dosed for 14 Days in Adult Subjects With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sturge-Weber Syndrome (SWS)
Glaucoma
Glaucoma Congenital
Ocular Hypertension
Keywords: Sturge-Weber Syndrome
Glaucoma
Elevated Intraocular pressure (IOP)
Lead sponsor: Qlaris Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients take 2 different doses of investigational product at distinct treatment periods. Dose is masked.
Primary purpose: TREATMENT

Brief summary: Safety and tolerability study of 2 concentrations of QLS-101 for adult subjects with Sturge Weber Syndrome (SWS)-related glaucoma due to elevated episcleral venous pressure (EVP).

Detailed description: Masked, randomized, single site, crossover study to compare 2 concentrations of QLS-101. Subjects will be randomized to one of 2 concentrations of QLS-101 for the first 14 days of daily dosing, and after a 14-day washout period they will be crossed over to the other concentration for another 14 days of daily dosing. Dose assignment is masked to patient and investigator.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with SWS.
* Elevated intraocular pressure (IOP)
* Willing to continue current dosing regimen of IOP-lowering medications
* Willing to refrain from contact lens use in the study eye.

Exclusion Criteria:

* IOP with variability of \> 4 mm Hg
* Expected to undergo IOP-lowering surgery
* Incisional or laser surgery of any type
* Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis
* A history of herpes simplex keratitis in either eye.
* History of or active clinically significant ocular disease
* Use of topical ocular corticosteroids in the 6 weeks prior to Visit 1

Primary outcomes:
measure: Ocular adverse events (AEs)
timeFrame: 56 days, including a 14-day washout
measure: Visual acuity
timeFrame: 56 days, including a 14-day washout
measure: Enhance depth imaging optical coherence tomography (EDI-OCT)
timeFrame: 56 days, including a 14-day washout
measure: Slit lamp exam
timeFrame: 56 days, including a 14-day washout
measure: Dilated fundus exam
timeFrame: 56 days, including a 14-day washout
Secondary outcomes:
measure: Ocular hypotensive efficacy
timeFrame: 14 days after each dosing timepoint is completed
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Qlaris Bio, Inc.
name: B. Wirostko, M.D.
role: STUDY_DIRECTOR
References: