louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01528436: Umbilical Cord Blood Therapy for Cerebral Palsy
Official title: Umbilical Cord Blood Therapy for Cerebral Palsy: a Randomized,Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Umbilical Cord Blood
Rehabilitation
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 37
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy.

Detailed description: Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.

Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain.

On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.

Eligibility criteria: Inclusion Criteria:

* Cerebral Palsy with abnormal muscle tone
* Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
* Willing to comply with all study procedure

Exclusion Criteria:

* Medical instability including pneumonia or renal function at enrollment
* Presence of known genetic disease
* Presence of drug hypersensitivity which is related to this study remedy
* Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
* Decision by the principal investigator when there are unexpected events including brain surgery, that may affect the outcome

Primary outcomes:
measure: Changes in Motor Performance
timeFrame: Baseline - 1 month - 3 months
measure: Changes in Standardized Gross Motor Function
timeFrame: Baseline - 1 month - 3 months
Secondary outcomes:
measure: Changes in Cognitive Neurodevelopmental Outcome
timeFrame: Baseline - 1 month - 3 months
measure: Changes in Motor Neurodevelopmental Outcome
timeFrame: Baseline - 1 month - 3 months
measure: Changes in Functional Independence in Daily Activities
timeFrame: Baseline - 1 month - 3 months
measure: Changes in Visual Perception Test
timeFrame: Baseline - 1 month - 3 months
measure: Changes in Muscle Strength
timeFrame: Baseline - 1 month - 3 months
measure: Changes in Functional Performance in Daily Activities
timeFrame: Baseline - 1 month - 3 months
measure: Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET
timeFrame: Baseline - 2 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
affiliation: CHA University
name: Minyoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06425536: Efficacy of Remineralizing Products Used in Molar Grooves: Evaluation With Diagnodent Pen and Diagnocam
Official title: Efficacy of Remineralizing Products Used in Molar Grooves: RCT With Evaluation With Diagnodent Pen and Diagnocam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enamel Caries
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the efficacy of enamel remineralization by biomimetic hydroxyapatite contained in microRepair-based Biorepair Total Protection toothpaste compared to the use of Bio Enamel Caries and Erosion toothpaste based on Fluoro-Hydroxyapatite and BioActive Complex, evaluated with Diagnodent Pen and Diagnocam.

Detailed description: The recruited patients will be divided into:

Group 1: Active group 20 patients undergoing quarterly oral hygiene sessions and home treatment using Biorepair Total Protection toothpaste 2 times/day

Gruppo 2: Active group 20 patients undergoing quarterly oral hygiene sessions and home treatment using Curasept Biosmalto Caries and Erosion toothpaste 2 times/day

For both groups, Diagnodent Pen will be used to evaluate the degree of demineralization, while Diagnocam will be used as qualitative evaluation.

Other clinical indices to be collected are: plaque index (PI), bleeding index (BOP), basic erosive wear examination (BEWE), Schiff Air Index (SAI).

The time frames of the study are:

* T0: baseline
* T1: after 1 month
* T2: after 3 months
* T3: after 6 months

Eligibility criteria: Inclusion Criteria:

* First permanent molars erupted and completely healthy
* Patients presenting C1 values 0-12 and C2 values 13-24 of the Diagnodent Pen

Exclusion Criteria:

* Patients with Diagnodent-stimulated value \> 25
* Patients with groove sealings of sealed permanent first molars or composite restorations
* First molars with extensive demineralizations (Molar Incisor Hypomineralization, fluorosis, white/brown spots)

Primary outcomes:
measure: Change in Diagnodent Pen value
timeFrame: Study begin, 1, 3 and 6 months after the baseline
measure: Change in Diagnocam value
timeFrame: Study begin, 1, 3 and 6 months after the baseline
measure: Change in Schiff Air Index
timeFrame: Study begin, 1, 3 and 6 months after the baseline
measure: Change in Bleeding on Probing
timeFrame: Study begin, 1, 3 and 6 months after the baseline
measure: Change in Plaque Index
timeFrame: Study begin, 1, 3 and 6 months after the baseline
measure: Change in Basic Erosive Wear Examination
timeFrame: Study begin, 1, 3 and 6 months after the baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05120336: tVNS Effects on Motivation in Depression
Official title: The Effects of Transcutaneous Vagus Nerve Stimulation on Motivation in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: vagus nerve stimulation
food reward
anhedonia
vigor
reward learning
mood
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Universität Tübingen
First posted: 2021-11-15
Enrollment: 67
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: BASIC_SCIENCE

Brief summary: Attaining goals or rewards commonly entails response costs. In light of cost and benefits, how do participants decide what effort should be put in to give it a shot? Figuratively, you may "go with your gut", but the literal contribution of the gut-brain axis in allocating effort is poorly understood to date. Here, the investigators propose to investigate non-invasive transcutaneous vagal nerve stimulation (tVNS) as a potential modulator of energy metabolism and response vigor. Since the neural mechanisms causing the diverse cognitive and behavioral effects of the stimulation remain largely elusive, the investigators will use computational modeling of instrumental behavior and determine the primary metabolic effects of the stimulation. The investigators hypothesize that tVNS will lead to activation of afferent targets in the brain. In turn, the elicited brain activation is expected to mediate the cognitive effects of the stimulation. This may affect both sides of the utility equation because anti-depressive effects may correspond to boosting the benefit of effort whereas anti-nociceptive effects may reduce perceived costs of effort. Collectively, dissecting the cognitive effects of non-invasive tVNS in healthy individuals may facilitate the more widespread use as a treatment in mental disorders that are characterized by metabolic alterations such as depression.


Eligibility criteria: Inclusion Criteria:

* 30 kg/m\^2 \> BMI \> 18.5 kg/m\^2

Exclusion Criteria:

lifetime

* brain injury
* coronary heart disease and occurred apoplexy
* schizophrenia
* bipolar disorder
* implants (e.g., cochlea implant)
* asthma

  12 month
* severe substance use disorders (DSM-V), except tobacco
* obessive compulsive disorder
* somatic symptom disorder
* eating disorder

Primary outcomes:
measure: Food reward ratings
timeFrame: during stimulation (compared to sham)
measure: Motivation to work for rewards: frequency of button presses to gain food an monetary rewards
timeFrame: during stimulation (compared to sham)
measure: Reward learning: correct choices
timeFrame: during stimulation (compared to sham)
measure: Positive and negative mood
timeFrame: Pre stimulation and 20 minutes post stimulation (compared to sham)
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department of Psychiatry & Psychotherapy, University of Tübingen
state: BW
Study officials:
References:
Clinical trial NCT00728936: Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
Official title: A Phase 1, Multi-center, Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 in Hepatitis C-infected Patients Unresponsive to Standard Treatment With Pegylated Interferon and Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: Hepatitis C
unresponsive to pegylated interferon and ribavirin therapy
hepatitis C virus
Lead sponsor: Idera Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.

Detailed description: First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125. Patients will proceed through a screening period, treatment period, and follow-up period of approximately 4 months' duration. There will be 4 dose cohorts including active drug and placebo dosing.

Eligibility criteria: Inclusion Criteria:

* HCV-positive
* Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin

Exclusion Criteria:

* Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg)
* Inadequate bone marrow, liver, and renal function
* Treatment with any IFN (interferon)-based or other experimental or antiviral therapies within 30 days
* Other significant medical diseases
* Known alcohol or drug abuse within the past 12 months

Primary outcomes:
measure: Evaluation of Safety.
timeFrame: From screening through study completion, 86 to 115 days in total
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Marietta
country: United States
facility: Gastoenterstinal Specialist of Georgia, PA
state: Georgia
city: Novi
country: United States
facility: Henry Ford Med Ctr- Columbus
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Dallas
country: United States
facility: The Liver Institute
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Santurce
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Idera Pharmaceuticals
name: Alice Bexon, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01230736: Safety and Efficacy of Changing to DuoTrav From Prior Therapy
Official title: Assessing the Safety and Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients Uncontrolled on Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-10-29
Enrollment: 105
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 to assess the safety and efficacy of changing to DuoTrav® from prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination) pharmacotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
* Must have an IOP of between 19 to 35 millimeters mercury (mmHg) (at any time of the day) in at least one eye (which would be designated as the study eye).
* Must be willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
* Women who are pregnant or lactating.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
* Corneal dystrophies in either eye.
* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
* Bronchial asthma or a history of bronchial asthma, bronchial hyper-reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
* History of severe allergic rhinitis.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change in Intraocular Pressure (IOP) at 8 weeks from prior therapy (baseline)
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of subjects who reach target IOP (≤18 mmHg)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Schweinfurt
country: Germany
Study officials:
References:
citation: Scherzer ML, Liehneova I, Negrete FJ, Schnober D. Travoprost 0.004%/timolol 0.5% fixed combination in patients transitioning from fixed or unfixed bimatoprost 0.03%/timolol 0.5%. Adv Ther. 2011 Aug;28(8):661-70. doi: 10.1007/s12325-011-0043-z. Epub 2011 Jul 15.
Clinical trial NCT06952036: The Epidemic Status and Development Trend of Hepatitis C Virus Infection in Pregnant Women in Xi'an
Official title: The Epidemic Status and Development Trend of Hepatitis C Virus Infection in Pregnant Women in Xi'an: A 10-Year Retrospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HCV Infection
HCV Elimination
Keywords: Hepatitis C
HCV elimination
Women of childbearing age
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 200000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who had an antenatal visit or gave birth between 2014 and 2023.

Brief summary: The objectives of this study are to improve HCV linkage-to-care in Chinese women and provide theoretical basis for the scientific formulation of HCV prevention and control strategies for pregnant women.

To understand the epidemiological changes and status of hepatitis C virus (HCV) infection in pregnant women in Shaanxi province in recent 10 years, and to analyze the main influencing factors of hepatitis C infection in pregnant women.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women or parturient women confirmed by blood HCG test.
2. Patients aged 18 years old and above.
3. Patients with HCV antibody seropositive or HCV RNA positive from 2014-2023.

Exclusion Criteria:

1. Patients without valid telephone numbers.
2. Duplicate records: For duplicate records of the same pregnant woman, only one record should be kept.

Primary outcomes:
measure: Relink rate
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05627336: Tokophobia ; Our Clinical Experience
Official title: Causes and Frequency of Tokophobia, Its Effect on Cesarean Delivery Rates: Our Clinical Experience
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Tocophobia
Pregnancy Complications
Keywords: vaginal birth
cesarean delivery
fear of childbirth
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3rd trimester pregnant women who are followed up in our clinic and will give birth in our clinic. Pregnant women between the ages of 18 and 40

Brief summary: Fear of childbirth, or what has historically been called tokophobia, is often described as a severe fear of birth and pathological fear of childbirth. The reasons for fear of childbirth are stated as biological reasons, psychological reasons and lack of social support. However, it is still not possible to clearly explain the reasons for the fear of childbirth in pregnant women and the risk factors affecting them. The reasons for the fear of childbirth and the affecting factors have not been fully explained.

Detailed description: The aim of this study is to examine the relationship between fear of childbirth and anxiety sensitivity in pregnant women, and whether the mode of delivery changes depending on this fear and these data. The aim of the authors is to reveal the frequency and causes of tokophobia in pregnant women followed in their clinics and to show the birth patterns of these patients.

Eligibility criteria: Inclusion Criteria:

* 3rd trimester pregnant women who are followed up in our clinic and will give birth in our clinic.
* Pregnant women between the ages of 18 and 40

Exclusion Criteria:

* Those in the risky pregnancy category (preeclampsia, gdm, iugr... etc.)
* Known to have fetal anomaly during follow-ups
* Those with chronic disease
* Those with sexually transmitted diseases
* Those with a history of cesarean section

Primary outcomes:
measure: diagnosis of tokophobia
timeFrame: 2 months
measure: type of birth
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem University Atakent Hospital, Department of Obstetrics and Gynecology,
Study officials:
References:
Clinical trial NCT00286936: Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo
Official title: Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hip Fracture
Delirium
Keywords: Hip fracture
delirium
sleep disturbance
hypnotic
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: IMK Fonden
First posted: 2006-02-06
Enrollment: 96
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture surgery

Detailed description: Delirium is prevalent after hip fracture surgery. Delirium has been linked to postoperative sleep disturbances. Zolpidem is a non-benzodiazepine hypnotic that preserves REM sleep. The present study investigates the incidence of delirium in hip fracture patients randomized to Zolpidem treatment 5 mg vs placebo in the perioperative phase.

Eligibility criteria: Inclusion Criteria:

* Primary hip fracture, no substance abuse, no regular opioid, corticosteroid or benzodiazepine therapy, hepatic insufficiency, myastenia gravis, allergies to drug components

Exclusion Criteria:

* Severe respiratory insufficiency

Primary outcomes:
measure: Incidence and severity of postoperative delirium
Secondary outcomes:
measure: Sleep quality
measure: mobilization
measure: loss of functional ability
measure: length of stay
measure: sedation
measure: nocturnal nursing events
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Nicolai B Foss, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04795336: Melatonin Use After Primary Total Joint Arthroplasty
Official title: Melatonin Use After Primary Total Joint Arthroplasty: A Randomized, Double Blind Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteo Arthritis Knee
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of melatonin supplementation on patient sleep quality, length of stay, and opioid consumption following primary, unilateral, elective total hip or knee arthroplasty.

Detailed description: This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing primary elective total hip and the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.

Eligibility criteria: Inclusion Criteria:

* Patient are current candidates for elective primary total hip and total knee arthroplasty.
* Patients ≥18 years of age but ≤ 95
* Patients have been medically cleared and scheduled for surgery

Exclusion Criteria:

* Non-elective conversion arthroplasty
* Bilateral total joint arthroplasty
* Contraindications to use of melatonin (diabetes, calcium channel blocker use, depression)
* Conditions and medications likely to confound results due to impact on subjective and/or objective sleep quality (insomnia, drug/alcohol abuse, and use of benzodiazepines, and prescription sleep aids)
* Conditions likely to impair capacity to adhere to protocol (mental impairment, psychiatric disorders other than anxiety/depression)

Primary outcomes:
measure: Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS)
timeFrame: Visit 1 (Screening Visit), Visit 2 (2 months post surgery)
Secondary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
timeFrame: Visit 1 (Screening Visit), 14 days after surgery visit
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Joshua C Rozell, MD
role: PRINCIPAL_INVESTIGATOR
References: