louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00173628: Autoantibodies in Patients With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Evaluate the autoantibodies, such as glutamic acid decarboxylase (GAD65), tyrosine phosphatase (IA-2 or ICA125), islet autoantibodies (IAA) and other associated autoimmune autoantibodies: microsomal antibodies, thyroglobulin antibodies, gastric parietal cell antibodies in patients with type 1 DM.

Detailed description: Type 1 diabetes mellitus (DM) is a common disease in pediatric endocrine clinic and epidemiological studies showed the racial variation in the incidence, with the highest of 35 cases per 100000 in Finland. The incidence of type 1 DM in Taiwan is reported to be 1.5 per 100000 for the population less than 30 years old. While the diagnosis is made, the residual islet cell function is only about 20% of normal population. Therefore, the principle therapy in these patients is insulin therapy lifelong.

The pathogenesis of type 1 diabetes mellitus is multifactorial and controversial, involving the genetic and environmental factors. Type 1 DM is an autoimmune disease, which is T cell mediated islet cell destruction. Ninety percent of patients with type 1 DM express at least one of the autoantibodies to the islet. Antibodies to glutamic acid decarboxylase 65 (GAD65) were observed in 60-80% of such patients, which were considered the most important autoantigens. The autoantibodies disappeared successively after diagnosis and decreased in concentrations over time, but titers of antibodies to GAD65 had been observed fluctuated in patients with type 1 DM.

The prevalence of GAD antibodies, insulin autoantibodies, IA-2 (tyrosine phosphatase) were reported as 45-67%, 23-67% and 49%, respectively in Taiwan. Other associated autoimmune disease, such as autoimmune thyroiditis were reported as 13-24%. Such differences may be caused by the enrolling criteria and different age population. Therefore, we want to elucidate the role of autoantibodies in the pathogenesis of type 1 DM.

Eligibility criteria: Inclusion Criteria:

* pediatric patients with type 1 diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi-Ching Tung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04605328: Cesarean Scar Defect (CSD); Prevalence, Risk Factors And Possible Associated Symptoms
Official title: Cesarean Scar Defect (CSD); Prevalence, Risk Factors And Possible Associated Symptoms: A Cohort Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Section Complications
Keywords: niche
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 225
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to Women Health Hospital for performing CS will be seen on regular visits for ultrasound scan for detection of CSD

Brief summary: The study aims to detect the incidence of Cesarean Scar Defect (CSD) in women undergoing CS in Women Health Hospital (WHH), assiut University, to identify risk factors for development of CSD and identify the possible gynaecological symptoms related to CSD.

Detailed description: All eligible women, who will undergo CS in Women Health Hospital (WHH) will be seen on regular visits to detect the presence of CSD by ultrasound and identify its characters and a questionnaire will be fulfilled by the candidates about the gynecological symptoms related to CSD and appeared after CS.

Eligibility criteria: Inclusion Criteria:

* All women who will undergo transverse lower segment cesarean section after 28 weeks gestational age (electively and Emergency), after counseling and written consent

Exclusion Criteria:

1. Rupture uterus (unscarred or scarred).
2. Upper segment CS.
3. Vertical lower segment CS.

Primary outcomes:
measure: the incidence of CSD in Women health Hospital
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ayman shamaash, PHD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Sherif Badran, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06044428: Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement
Official title: Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Temperature
Postoperative Infection
Pneumonia
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be inpatients at the Medical University of Graz, where the need to have a visceral surgery.

Brief summary: The goal of this observational study is to review whether postoperative infections can be detected earlier by a continuous measurement of body temperature of patients compared to single daily measurements. Within 25 weeks 100 patients, which underwent visceral surgery less than 48h ago, will be included. A patch (Steadytemp ®) will be attached to participants, continuously measuring the body temperature. In addition infection parameters and medication of the participants will be documented.


Eligibility criteria: Inclusion Criteria:

* participant is willing and able to give informed consent for participation in the study
* age 18 years and above
* visceral surgery procedure within the last two days
* inpatient stay on the ICIÜ (Interdisciplinary surgical intensive care unit) or normal ward

Exclusion Criteria:

* allergy to the ingredients of skin patches
* major psychiatric diseases including history of drug or alcohol abuse
* chronic inflammatory disease in the medical history
* predicted inpatient stay is less than 5 days
* operational wound is too close to the patch adhesive site
* the skin at the intended adhesive site of the patch is not intact
* BMI \> 33

Primary outcomes:
measure: Temperature curve (body temperature in °C)
timeFrame: min. 5 days and max. 21 days
measure: wound infection or pneumonia
timeFrame: min. 5 days and max. 21 days
Secondary outcomes:
measure: Inflammation parameter in the blood: PCT (Procalcitonin)
timeFrame: min. 5 days and max. 21 days
measure: Inflammation parameter in the blood: CRP (c-reactive protein)
timeFrame: min. 5 days and max. 21 days
measure: Inflammation parameter in the blood: Leukocytes
timeFrame: min. 5 days and max. 21 days
measure: Use of medication
timeFrame: min. 5 days and max. 21 days
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University Graz, Department of Surgery, Division of general, visceral and transplant surgery
name: Dr. Philipp Stiegler, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06849128: NeuroReAlign Therapy for Cognitive Rehabilitation in Patients with Stroke
Official title: Effects of NeuroReAlign Therapy on Cognition in Patients with Stroke: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Middle East University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to investigate the effects of NeuroReAlign Therapy on cognition in stroke survivors in the chronic stage (\>6 months). The study will include male and female participants aged 18-70 years.

The main questions it aims to answer are:

Does NeuroReAlign Therapy improve cognition in stroke survivors compared to conventional physiotherapy? Researchers will compare NeuroReAlign Therapy to conventional cognitive therapy to determine its effects on cognition.

Participants will:

Undergo NeuroReAlign Therapy or conventional cognitive therapy for 4 weeks. Have their cognition evaluated using the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), Trail Making Test (TMT), Stroop Test, Digit Span Test, and Verbal Fluency Test (VFT).

Complete outcome assessments at baseline and after the intervention (week 4).


Eligibility criteria: Inclusion Criteria:

* Patients with ischemic or hemorrhagic stroke
* Have a stroke more than 6 months
* Age between 18 and 70

Exclusion Criteria:

* Patients with severe cognitive impairments
* Patients cannot walk independently

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: At baseline (week 0) and post-intervention (week 4)
Secondary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: At baseline (week 0) and post-intervention (week 4)
measure: Trail Making Test (TMT)
timeFrame: At baseline (week 0) and post-intervention (week 4)
measure: Stroop Test
timeFrame: At baseline (week 0) and post-intervention (week 4)
measure: Digit Span Test
timeFrame: At baseline (week 0) and post-intervention (week 4)
measure: Verbal Fluency Test (VFT)
timeFrame: At baseline (week 0) and post-intervention (week 4)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00070928: Valerian to Improve Sleep in Patients With Parkinson's Disease
Official title: Polysomnographic Assessment of Alternative Treatments for Sleep Disturbance in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia
Parkinson's Disease
Keywords: Sleep
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-10-13
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to test the short-term effectiveness of valerian, a medicinal herb, to improve sleep in patients with Parkinson's disease (PD).

Detailed description: Patients with PD have exceptionally poor sleep. Sleep in patients with PD is characterized by excessive activity in surface electromyographic (EMG) recordings from many different muscle groups. Despite sleep disturbances, approximately 50% of patients experience a transient (1 to 3 hour) reduction in waking motor symptoms upon arising in the morning. This effect has been termed Sleep Benefit. This study will evaluate the effects of valerian, a medicinal herb, on the sleep of patients with PD.

This is a 17 day study where participants will be evaluated by polysomnography on days one, two, three, sixteen and seventeen.. Polysomnographic measurements will include customary variables such as total sleep time, sleep efficiency, and sleep latency, as well as EMG measures of periodic and isolated muscle activity during sleep. Participants will be required to keep a detailed sleep log of their self reported sleep characteristics across the entire 17 study nights. Outcomes will include measures of both nocturnal sleep and waking motor function. Assessments of motor function will be made the morning immediately following Nights 3 and 17 in order to test for improvement related to improved sleep. On the morning following Night 17, participants are provided with a one-week supply of valerian in an Open Label extension. Participants are provided an additional Sleep Log for this week and asked to return the Sleep Log when they complete the Open Label phase.

Eligibility criteria: Inclusion Criteria

* Idiopathic Parkinson's disease
* Willing to undergo overnight, in-lab polysomnography
* Sufficient literacy to allow completion of sleep logs
* Stable doses and timing of all Parkinsonian medications during the course of the trial

Exclusion Criteria

* Dementia
* Parkinsonism secondary to toxic, infectious, or other medical conditions
* History of stroke, cerebellar disease, or progressive supranuclear palsy
* History of liver or renal disease
* History of duodenal or bladder obstruction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Medical School/Wesley Woods Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Donald L. Bliwise, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03673228: Preventing Smoking Relapse After Total Joint Replacement Surgery
Official title: Preventing Smoking Relapse After Total Joint Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking Cessation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hospitalization for elective knee or hip replacement surgery presents an outstanding opportunity to motivate people to quit smoking, because it provides an opportunity to encourage patients to remain smoke-free as they proactively quit to optimize their surgery outcomes. This study will conduct a comparative effectiveness trial of patients who quit smoking pre-operatively, comparing the current standard of care with a novel comprehensive relapse prevention intervention guided by Marlatt's Relapse Prevention Model.

Detailed description: The specific aims of this study are to evaluate the effectiveness and cost-effectiveness of the relapse prevention intervention and will: 1) compare the effectiveness of standard post-operative cessation treatment with a comprehensive relapse prevention intervention on smoking cessation outcomes; 2) conduct a comparative economic analysis to assess the value of the relapse prevention intervention for patients and the healthcare system; and 3) explore the impact of the interventions on surgical complications and readmissions.

Eligibility criteria: Inclusion Criteria:

Patient Participants

* Received preoperative smoking cessation counseling through Orthopedic Surgery Quit Smoking Program
* Undergoing elective knee or hip arthroplasty surgery
* Have not smoked any cigarettes in the week prior to admission and carbon monoxide 4 ppm46,47
* Have a cell phone (for text messaging)
* Provide informed consent in English

Caregiver participants:

* Age ≥ 18 years
* Be a caregiver of the patient participant
* Provide informed consent in English

Exclusion Criteria:

* Patients will be excluded if they used smokeless tobacco or an electronic cigarette in the last 30 days.

Primary outcomes:
measure: Self Reported Relapse Rate for Usual Care Arm
timeFrame: 3 Months
measure: Self Reported Relapse Rate for Usual Care Arm
timeFrame: 6 Months
measure: Self Reported Relapse Rate for Usual Care Arm
timeFrame: 12 Months
measure: Self Reported Relapse Rate for relapse prevention intervention arm
timeFrame: 3 Months
measure: Self Reported Relapse Rate for relapse prevention intervention arm
timeFrame: 6 Months
measure: Self Reported Relapse Rate for relapse prevention intervention arm
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Scott Sherman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01196728: Single-centre, Randomised, Double-blind, Placebo-controlled, Four-way Crossover Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Doses of CM3.1-AC100 in Patients With Type 2 Diabetes
Official title: Single-centre, Randomised, Double-blind, Placebo-controlled, Four-way Crossover Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Doses of CM3.1-AC100 in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type II Diabetes Mellitus
Lead sponsor: CellMed AG, a subsidiary of BTG plc.
Sponsor class: INDUSTRY
First posted: 2010-09-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of this study is to assess the safety and tolerability of the Glucagon-like peptide-1 (GLP-1) peptide analogue CM3.1-AC100 after single subcutaneous (sc) doses in patients with T2DM.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent prior to any study specific procedures
2. Type 2 diabetes mellitus patient, diagnostically confirmed since at least 6 months
3. Male or female patient aged 18 to 75 years at screening, both inclusive
4. BMI \>22 to ≤40 kg/m2 at screening

Exclusion Criteria:

1. Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, eg Cushings's syndrome and acromegaly
2. Fasting C-peptide \< 500 pM at screening
3. Acute gastrointestinal symptoms at the time of screening and/or Day -1
4. Any clinically relevant history or the presence of cardiovascular, bronchopulmonary, gastrointestinal or neurological diseases inclusive history of chronic pancreatitis or acute pancreatitis

Primary outcomes:
measure: Safety measurements
timeFrame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
Secondary outcomes:
measure: PK samples for CM3.1-AC100
timeFrame: Intense PK-sampling during the 24 hours following administration of CM3.1-AC100
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: CellMed AG, a subsidiary of BTG plc.
name: Peter Geigle, Dr. med.
role: STUDY_CHAIR
References:
Clinical trial NCT03224728: Spherical Aberration on the Optical of Two Different Aspherical Intraocular Lenses
Official title: Effect of Spherical Aberration on the Optical Quality After Implantation of Two Different Aspherical Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Hospital Hietzing
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women between 50 and 85 years with age related cataract

Brief summary: Purpose: To compare the effect of spherical aberration on optical quality in eyes with two different aspherical intraocular lenses Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes an aberration-free aspherical IOL (Aspira-aA; Human Optics) or an aberration-correcting aspherical IOL (Tecnis ZCB00; Abott Medical Optics) were randomly implanted. Three months after surgery visual acuity, contrast sensitivity, wavefront measurements with iTrace as well as tilt and decentration measurements with Visante anterior segment OCT were performed.


Eligibility criteria: Inclusion Criteria:

* Bilateral age-related cataract
* Potential postoperative visual acuity of 1.0 Snellen
* No relevant ocular pathology other than cataract
* Written informed consent to surgery and participation in the study

Exclusion Criteria:

* Amblyopia, diabetic retinopathy, uveitis or other relevant ophthalmic diseases
* Optical media disturbances due to: corneal and vitreal opacity, PEX
* Preceding ocular trauma or ocular surgery within 6 months
* Inability to cooperate
* Pregnancy (a pregnancy test will be performed preoperatively in women of reproductive age)

Primary outcomes:
measure: Modulation transfer function (MTF) at 3 months after surgery
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lasta M, Mihaltz K, Kovacs I, Vecsei-Marlovits PV. Effect of Spherical Aberration on the Optical Quality after Implantation of Two Different Aspherical Intraocular Lenses. J Ophthalmol. 2017;2017:8039719. doi: 10.1155/2017/8039719. Epub 2017 Aug 16.
Clinical trial NCT05768828: Stimulation-evoked Calcitonin Gene-Related Peptide (CGRP) as Biomarker of Migraine
Official title: Calcitonin Gene-Related Peptide (CGRP) and Neurophysiological Biomarkers of Migraine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Migraine
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited through the outpatient headache department and through public adverstisement. Patients are consecutively recruited and inclusion/exclusion criteria are minimzied to avoid selection bias.

Brief summary: This study aims to improve the management migraine by providing a more profound understanding of the interactions of pain disinhibition on the brain stem level and calcitonin gene-related peptide as a main mediator in the generation of migraine headaches. For this purpose, this observational study investigates established neurophysiological and blood biomarkers parameters in association with the clinical phenotype.

Detailed description: The study's focus is the investigation of mechanisms that are directly related to the pain generation in migraine. In this context, the primary endpoint is an enhancement of trigeminal stimulation evoked calcitonin gene-related peptide (CGRP). The stimulation is normalized using an established protocol to elicit the nociceptive blink reflex, which is a brain stem reflex to study the trigemino-spinal system. We expect CGRP levels to rise more in patients affected by migraine as compared to controls, based on the observation that painful stimulation elicits migraine attacks. Furthermore, baseline CGRP levels and their association with markers of brainstem excitability are probed.

Eligibility criteria: Inclusion Criteria:

* Migraine according to ICHD-3 criteria (cases)
* No headaches or tension-type headache frequency \<1x/year (controls)

Exclusion Criteria:

* other chronic pain disorder

Primary outcomes:
measure: Plasma levels of Calcitonin Gene-Related Peptide
timeFrame: cross-sectional, once after stimulation
Secondary outcomes:
measure: Lacrimal fluid levels of Calcitonin Gene-Related Peptide
timeFrame: cross-sectional, once after stimulation
measure: Habituation of the nociceptive blink reflex in correlation with plasma levels of Calcitonin Gene-Related Peptide
timeFrame: cross-sectional, once before stimulation
measure: Habituation of the nociceptive blink reflex in correlation with lacrimal fluid levels of Calcitonin Gene-Related Peptide
timeFrame: cross-sectional, once before stimulation
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
Study officials:
References: