louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02373696: Chronic Pain Dynamic Psychophysical Tests and Genetic Screening
Official title: Prediction of Chronic Pain in the Asian Population- Comprehensive Programme Encompassing Dynamic Psychophysical Tests and Genetic Screening to Determine and Prevent Persistent Post-caesarean Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Pain
Caesarean section
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2015-02-27
Enrollment: 178
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing spinal anaesthesia for Caesarean section

Brief summary: Incidence and risk factors for persistent post surgical pain after Caesarean section are investigated. Demographic, psychophysical testing and genetic screening factors are performed in the perioperative period. Phone survey is performed to investigate the incidence of persistent post surgical pain after Caesarean section.

Detailed description: Persistent post surgical pain after Caesarean section may lead to functional limitation and pain during activities of daily living. Demographic factors, psychophysical factors (mechanical temporal summation, diffuse noxious inhibitory control, state trait anxiety inventory) and genetic screening are used to predict the association with persistent post surgical pain. Phone survey follow up is performed to investigate the incidence of persistent post surgical pain and functional limitations due to pain experienced.

Eligibility criteria: Inclusion Criteria:

* Women undergoing spinal anaesthesia for Caesarean section

Exclusion Criteria:

* Failed spinal anaesthesia, Unable to perform psychophysical testing.

Primary outcomes:
measure: Persistent Postsurgical Pain
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban L Sng, FANZCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02176096: Comparison of the Effect of a Novel Starch (Glycosade) Versus Gastrostomy Tube-Dextrose Infusion on Overnight Euglycaemia Control in Children With Glycogen Storage Disease Type I: Open Label Demonstration Trial
Official title: Comparison of the Effect of a Novel Starch (Glycosade) Versus Gastrostomy Tube-Dextrose Infusion on Overnight Euglycaemia Control in Children With Glycogen Storage Disease Type I: Open Label Demonstration Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycogen Storage Disorder Type 1
Hypoglycemia
Cornstarch
Glycosade
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Co-Investigator - Dr. Cheryl Rockman-Greenberg
First posted: 2014-06-26
Enrollment: 4
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this demonstration project is to compare a novel long-acting starch, Glycosade, a hydrothermally processed high amylopectin maize starch, versus gastrostomy tube-dextrose infusion in maintaining euglycaemia overnight in children with GSD-I. Glycosade has been reported to increase the duration of euglycaemia. Its slow release and longer periods of normal blood sugar achieved would preclude the need for the overnight dextrose infusion and eliminate the need for the surgical insertion of a gastrostomy tube for this purpose. Glycosade also reportedly causes fewer gastrointestinal side effects, thus potentially improving compliance to therapy. The investigators intend to evaluate Glycosade in our patients and determine its efficacy on glucose control, on the length of normoglycemia achieved and to determine if there are reduced side effects in our patients with GSD-I. This will be accomplished by an open label study of Glycosade in GSD-I patients who consent to the protocol.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of GSD Type 1
* Age \>5 years

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Normal Blood Glucose
timeFrame: Overnight
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Chrildren's Hospital Research Institute of Manitoba
state: Manitoba
Study officials:
References:
Clinical trial NCT06131996: The Effect of Splints in Pregnant Women With Carpal Tunnel Syndrome
Official title: Comparison of the Effects of Volar-assisted and Elastic Wrist Splints on Edema, Pain, Grip Strength and Functionality in Pregnant Women With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Pregnancy Related
Splints
Lead sponsor: Mardin Artuklu University
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is aimed to compare the effect of two different splints on carpal tunnel syndrome in pregnant individuals after 4 weeks of use.

Detailed description: Carpal tunnel syndrome (CTS) is a common musculoskeletal problem in pregnancy. The aim of this study is to compare the effects of rigid and elastic wrist splints on edema, pain levels, grip strength, and upper extremity functionality in pregnant women with CTS.

Pregnant women in the last trimester of pregnancy who were diagnosed with CTS were included in the study.

Eligibility criteria: Inclusion Criteria:

* Being in the last trimester of pregnancy,
* Having a diagnosis of CTS,
* Positive Tinnel and Phalen tests,
* Pain, tenderness, and numbness symptoms in the median nerve neurodynamic test,
* pain of at least 4 severity according to VAS,
* Edema due to pregnancy

Exclusion Criteria:

* Individuals in the 1st or 2nd trimester of pregnancy,
* Those with pain complaints below 4 according to VAS,
* Those with a history of CTS before pregnancy,
* Those who had undergone surgery in the hand-wrist region
* Those diagnosed with cervical disc herniation

Primary outcomes:
measure: Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)
timeFrame: before intervention and 4 weeks after intervention
measure: The Boston Questionnaire (BA)
timeFrame: before intervention and 4 weeks after intervention
measure: Grip strength
timeFrame: before intervention and 4 weeks after intervention
measure: Volumetric measurement
timeFrame: before intervention and 4 weeks after intervention
measure: Visual Analog Scale (VAS)
timeFrame: before intervention and 4 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Mardin
country: Turkey
facility: Mardin Artuklu University
Study officials:
affiliation: MARDİN ARTUKLU UNİVERSİTY, VOCATIONAL SCHOOL OF HEALTH SERVICES,
name: Funda CAVUS
role: STUDY_DIRECTOR
References:
Clinical trial NCT02676596: Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemia
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the safety tolerability, and PK profile of K-312 and its metabolites in healthy Japanese and non-Japanese adults.


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is a healthy adult male or a female of non-childbearing potential between the ages of 18 and 45 years, inclusive.
* Subject has a body mass index of 18.5 to 30 kg/m2, inclusive.
* Subject has hematology, coagulation, serum chemistry, and urinalysis test results within the reference ranges or showing no clinically relevant deviations, as judged by the Investigator.

Exclusion Criteria:

* Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
* Subject has any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-312. Cholecystectomy is permitted if there are no postcholecystectomy gastrointestinal symptoms.
* Subject has clinically relevant abnormalities in clinical laboratory parameters.

Primary outcomes:
measure: CETP activity
timeFrame: Days 1, 3, 6, 11, 16, 21, 27 and 30
measure: Area under the plasma concentration
timeFrame: Days 1 and 21
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
References:
Clinical trial NCT00742196: Retinal Nerve Fiber Layer Thickness Measurement on Parapapillary Atrophy With the Cirrus High-Definition (HD) Optical Coherence Tomography (OCT)
Official title: Retinal Nerve Fiber Layer Thickness Measurement on Parapapillary Atrophy With
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Keywords: Parapapillary atrophy
Retinal nerve fiber layer thickness
Glaucoma
Cirrus OCT
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2008-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with or without parapapillary atrophy

Brief summary: Retinal nerve fiber layer (RNFL) thickness measurement on the parapapillary atrophy is incorrect. Because a new spectral domain OCT, the Cirrus HD OCT, uses a movable circle to analyze the RNFL thickness, we may suggest a new analysis strategy for the parapapillary atrophy.

Detailed description: Recently, the retinal nerve fiber layer (RNFL) thickness measurement using the optical coherence tomography (OCT) becomes very useful to detect such a glaucomatous damage. However, there are some difficult cases including parapapillary atrophy to perform this measurement. Because the RNFL thickness is so sensitive to the position of measurement and the measurement of RNFL thickness on parapapillary atrophy is incorrect, it is difficult to determine exact RNFL thickness in patients with a large parapapillary atrophy. In the present study, we want to find the proper method to analyze the RNFL thickness on parapapillary atrophy. The previous OCT used a fixed circle to measure the RNFL thickness, but the new spectral domain OCT, the Cirrus HD OCT, uses a movable one. Therefore, we may suggest a new analysis strategy for the parapapillary atrophy.

Eligibility criteria: Inclusion Criteria:

* Qualified OCT images (signal strength \> or = 8)

Exclusion Criteria:

* Previous intraocular surgery history
* Media opacity
* DM

Primary outcomes:
measure: Retinal nerve fiber layer thickness
timeFrame: when the OCT images are taking
measure: Size of parapapillary atrophy
timeFrame: when the OCT images are taking
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gong Je Seong
Study officials:
affiliation: Yonsei University
name: Gong Je Seong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06710496: HISTOLOGICAL RESULTS IN TRANSGENDER INDIVIDUALS ASSIGNED TO FEMALES AT BIRTH UNDERGOING GENDER AFFIRMATION SURGERY AND IN TESTOSTERONE THERAPY
Official title: HISTOLOGICAL RESULTS IN TRANSGENDER INDIVIDUALS ASSIGNED TO FEMALES AT BIRTH UNDERGOING GENDER AFFIRMATION SURGERY AND IN TESTOSTERONE THERAPY
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnancy
Smoking Behavior
Testosterone Replacement Therapy
Drugs
Comorbidities and Coexisting Conditions
Gynecological Surgery
Transgender Men
Gender Affirmation Surgery
Hormone Replacement Therapy
Gynecological Disorders
Keywords: transgender
afab
histology
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: transgender people assigned female at birth undergoing gender affirming surgery with hysterectomy and on testosterone therapy

Brief summary: The aim of this study is to report histological results of genital organs removed during gender affirmg surgery in transgender people assigned female at birth (AFAB), to increase the knowledge about the long-term effects of gender affirming hormone therapy with testosterone on these organs and to evaluate the incidence of benign and malign gynecological pathology in AFAB transgender people.

Detailed description: This retrospective, observational, single-center study aims to analyze histological data obtained from the analysis of ovaries, fallopian tubes, uterine body, endometrium, and cervix of assigned female at birth (AFAB) transgender individuals who underwent gender affirming surgey (GAS) with hysterectomy and bilateral adnexectomy or hysterectomy alone following the administration of exogenous Testosterone (T). Histological results of the genital organs removed during GAS can provide important information about the effects and safety of loong term T treatment on these organs. Data on this subject is scarce in the literature. For this reason, even today, pathologists have not been able to establish guidelines for describing the histological results obtained from these patients.Furthermore, this analysis will evaluate the incidence of benign and malignant gynecological pathology in AFAB transgender people.

Eligibility criteria: Inclusion Criteria:

* gender incongruence diagnosis
* people assigned female at birth
* age \>18 years
* gender affirming surgery with hysterectomy
* testosterone therapy

Exclusion Criteria:

* previous gynecological surgery
* previous gynecological disorder diagnosis

Primary outcomes:
measure: histological description of genital organs
timeFrame: 6 months
Secondary outcomes:
measure: prevalence of malignant and benign gynecological pathology
timeFrame: 6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: irccs azienda ospedaliero universitaria di Bologna
state: Emilia Romagna
Study officials:
References:
Clinical trial NCT05508516: Shugan Dingtong Decoction in the Treatment of Fibromyalgia
Official title: The Efficacy and Safety of the Shugan Dingtong Decoction in the Treatment of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fibromyalgia
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 72
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: Fibromyalgia (FM) is a syndrome characterized by chronic and widespread musculoskeletal pain, fatigue sleep disturbances and cognitive and somatic symptoms. It is commonly conjectured that central sensitization is physiological hallmark of FM. Therefore, centrally acting medications including antidepressants and anticonvulsants are used to treat FM via downregulating dorsal horn sensitization and systemic hyperexcitability.However, those drugs are limited in clinical practice resulting from dose-limiting adverse effects and incomplete drug efficacy.Shugan Dingtong decoction(SGDTD) is a Chinese herbal formula and has been used for treatment of FM in clinical practice many years. However, few research can provide high-quality evidence on the efficacy and safety of SGDTD for the treatment of FM. Therefore, a parallel-group randomized controlled trial was designed to evaluate the efficacy and safety of SGDTD on FM.


Eligibility criteria: Inclusion Criteria:

* patients aged 18-70 years old.
* patients who meet the diagnostic criteria of American College of Rheumatology in 2016.
* patients who meet the diagnostic criteria of Syndrome of stagnation of liver qi.
* pain scores between3 and 7 on visual analogue scale.
* patients sign the informed consent forms.

Exclusion Criteria:

* pregnant and lactating women.
* patients with serious primary diseases of respiratory, digestive, urinary, cardiovascular and immune system.
* patients with mental and psychological disorders including cognitive im-pairment, severe depression, somatoform disorders.
* patients with secondary fibromyalgia resulted from osteoarthritis, rheumatoid arthritis, trauma, hypothyroidism, malignant tumor.
* patients with severe pain resulted from diabetic and postherpetic neuralgia.
* patients who are allergic to the drugs used in this study.
* patients are participation in any other clinical trials or receive other drugs for the treatment of fibromyalgia.

Primary outcomes:
measure: Visual analogue scale pain scores
timeFrame: 12 Weeks
Secondary outcomes:
measure: Fibromyalgia impact questionnaire
timeFrame: 12 Weeks
measure: Fatigue scale-14
timeFrame: 12 Weeks
measure: Pittsburgh sleep quality index
timeFrame: 12 Weeks
measure: Traditional Chinses medicine symptom score
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04491916: Iron Therapy in Patients With End-Stage Renal Disease
Official title: A Cross-over Trial to Evaluate the Efficacy and Safety Between Increasing the Dose of Iron and Original Iron Dosage in Patients With Maintenance Hemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End-stage Renal Disease
Anemia
Cardiovascular Risk Factor
Inflammation
Keywords: iron
End-Stage Renal Disease
Anemia
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will compare the clinical outcome of patients with maintenance dialysis room after changing the iron treatment guidelines from original upper limit with ferritin\>500ng/ml, or TSAT\>20% to Ferritin\> 800ng / ml, or TSAT\> 50%.

Detailed description: After two years of treatments, we will compare the incidence of clinical events, monthly blood, and biochemical examination data for the two years before and after the change.

Eligibility criteria: Inclusion Criteria:

* patients receiving maintenance dialysis

Exclusion Criteria:

* less than 20 year-old, oncological patients undergoing chemotherapy, abnormal liver function, infection

Primary outcomes:
measure: Mortality
timeFrame: 2 years
measure: coronary artery disease
timeFrame: 2 years
measure: coronary artery disease
timeFrame: 2 years
measure: coronary artery disease
timeFrame: 2 years
measure: congestive heart failure
timeFrame: 2 years
measure: congestive heart failure
timeFrame: 2 years
measure: congestive heart failure
timeFrame: 2 years
measure: congestive heart failure
timeFrame: 2 yearts
Secondary outcomes:
measure: diabetes
timeFrame: 2 years
measure: diabetes
timeFrame: 2 years
measure: diabetes
timeFrame: 2 years
measure: anemia
timeFrame: 2 years
measure: calcium
timeFrame: 2 years
measure: phospate
timeFrame: 2 years
measure: nutrition status
timeFrame: 2 years
measure: liver function
timeFrame: 2 years
measure: liver function
timeFrame: 2 years
measure: sodium
timeFrame: 2 years
measure: potassium
timeFrame: 2 years
measure: parathyroid function
timeFrame: 2 years
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: Hugo Y Lin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaohsiung Municipal Ta-Tung Hospital
name: Hugo Y Lin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05047016: Study to Evaluate the Dynamic Consent Model Based on the Blockchain-based Clinical Trial Platform METORY
Official title: A Virtual Clinical Trial to Implement and Evaluate the Dynamic Consent Model Based on the Blockchain-based Next-generation Clinical Trial Platform METORY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19 Pneumonia
Keywords: blockchain, dynamic consent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Blockchain technology has gained attention for its decentralized feature and data integrity. The study aims to apply blockchain technology to implement dynamic consent model and evaluate the real-world experience as a form of virtual clinical trial.

Detailed description: The study will simulate a clinical trial that implements dynamic consent module. In this study, two major and three minor protocol amendments will be conducted on the scheduled date. Each subjects will give consent using the dynamic consent platform, METORY, and will be informed when the protocol is amended. The communication only be conducted under the METORY and the real-world experience of METORY would be evaluated.

Eligibility criteria: Inclusion Criteria:

* Subjects who can use METORY (application platform)
* Subjects who completely understand the study and voluntarily decide to participate in the study

Exclusion Criteria:

* Subjects who are not able to use the web or application due to cognitive dysfunction or other reasons
* Subjects who are not able to measure body temperature by themselves
* Subjects who investigators decide not be appropriate for the study for other reasons

Primary outcomes:
measure: Response time
timeFrame: Study Period of 4 weeks
Secondary outcomes:
measure: Study completion rate
timeFrame: Study Period of 4 weeks
measure: Dropout rate
timeFrame: Study Period of 4 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
state: Jeollabuk-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: SeungHwan Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: