louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02333877: Comparison of Skinlink With Suture for ED Patients
Official title: Comparison of Skinlink With Suture for ED Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds and Injuries
Lacerations
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether suture using the Device of "Leukosan Skinlink" is more faster and safer than that of "nylon" in the treatment of simple wound for ED patients.


Eligibility criteria: The inclusion criteria were age 18-75 years,presence of a partial thickness laceration, generally good health without systemic abnormalities,agreement to return for a 14-day follow-up, and written informed consent. The exclusion criteria were previous diagnosis of diabetes mellitus, peripheral vascular disease, or bleeding disorders; history of keloid formation or scar hypertrophy; and allergy to cyanoacrylate compounds or formaldehyde

Primary outcomes:
measure: Time required to complete suture
timeFrame: 1year
Secondary outcomes:
measure: Dehiscence
timeFrame: 1year
measure: Infection rate
timeFrame: 1year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
Study officials:
References:
citation: Kim H, Kim W, Kang GH, Jang YS, Choi HY, Kim JG, Kim IY, Kim M. Comparison of Leukosan SkinLink with surgical suture for traumatic laceration repair: A randomized controlled trial. Medicine (Baltimore). 2018 Jun;97(25):e10918. doi: 10.1097/MD.0000000000010918.
Clinical trial NCT06976177: Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis
Official title: A Multi-center, Open, Single-arm Phase IIb Clinical Study to Evaluate the Safety and Efficacy of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
Lead sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open, single-arm phase IIb clinical study comprising 2 parts, which Part A will enroll about 110 subjects, and Part B will enroll about 190 subjects to investigate long-term efficacy and safety of MT1013 after treatment.The treatment duration for Part A MAD study is 52 weeks and the duration for Part B study is 26 weeks.


Eligibility criteria: Inclusion Criteria:

* 1. Subject capable of understanding written information ,willing to participate in, and provide a written informed consent; 2.Male or female subjects must be at least 18 years old when signing the informed consent; 3.The subjects must undergo maintenance hemodialysis three times a week or five times two weeks for at least three months； 4.Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L); 5.Diagnosed of Secondary Hyperparathyroidism (SHPT);

Exclusion Criteria:

* 1.Primary hyperparathyroidism; 2.Refusal to discontinue cinacalcet, etelcalcetide, or other calcimimetics during the study; 3.Has used RANKL inhibitors such as denosumab within 6 months before screening. 4.Diagnosed with gastrointestinal bleeding within 6 months prior to screening; 5.Subjects with severe uncontrolled hypertension, defined as systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg, despite optimal drug treatment prior to enrollment; 6.The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy during the study; 7.Subjects are allergic or intolerant to any component of the investigational drug； 8.History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;

Primary outcomes:
measure: The occurrence of adverse events within 26 weeks
timeFrame: Baseline up to 26 weeks
Secondary outcomes:
measure: Percentage of participants with iPTH during 150-300pg/mL at week 26
timeFrame: at week 26
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01283477: Efficacy of Acupuncture for Prophylaxis of Intrathecal Morphine Induced Pruritis in Patients Undergoing Caesarean Delivery
Official title: Efficacy of Acupuncture for Prophylaxis of Intrathecal Morphine Induced Pruritis in Patients Undergoing Caesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture
Morphine Induced Pruritis
Keywords: Caesarean Delivery
Pruritis
Intrathecal Morphine
Acupuncture At LI11
Lead sponsor: Letterkenny General Hospital
Sponsor class: OTHER_GOV
First posted: 2011-01-26
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intrathecal morphine is commonly used for pain relief in caesarean delivery. Side effects such as itch (pruritis) and nausea \& vomiting are common and have been shown to be the most common cause for dissatisfaction. The incidence of pruritis is 74% even with current available medications. Acupuncture has been shown to be effective for morphine related side effects but has not been evaluated for prophylaxis of itch in pregnant population.

PRIMARY OBJECTIVE:

Acupuncture at LI 11 reduces the incidence of pruritis after elective caesarean section under spinal with intrathecal morphine


Eligibility criteria: Inclusion criteria:

* ASA I \& II patients undergoing elective caesarean delivery under spinal with intrathecal morphine

Exclusion criteria:

* Patient refusal
* ASA III \& IV patients
* Pre-existing pruritis
* Eczema
* Bleeding tendencies
* Known allergy to any of medications used
* Any contra indication to spinal anaesthesia

Primary outcomes:
measure: Incidence of pruritis
timeFrame: First 24 hr post intrathecal morphine
Secondary outcomes:
measure: Severity of pruritis
timeFrame: 1, 4, 8, 24 hr post intrathecal morphine
Other outcomes:
Locations:
city: Letterkenny
country: Ireland
facility: Letterkenny General Hospital
state: Donegal
Study officials:
affiliation: Letterkenny General Hospital
name: KARTHIK G RAMAMOORTHY, MBBS, DA,DAc,FCARCSI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jiang YH, Jiang W, Jiang LM, Lin GX, Yang H, Tan Y, Xiong WW. Clinical efficacy of acupuncture on the morphine-related side effects in patients undergoing spinal-epidural anesthesia and analgesia. Chin J Integr Med. 2010 Feb;16(1):71-4. doi: 10.1007/s11655-010-0070-7. Epub 2010 Feb 4.
citation: Che-Yi C, Wen CY, Min-Tsung K, Chiu-Ching H. Acupuncture in haemodialysis patients at the Quchi (LI11) acupoint for refractory uraemic pruritus. Nephrol Dial Transplant. 2005 Sep;20(9):1912-5. doi: 10.1093/ndt/gfh955. Epub 2005 Jun 28.
citation: Bonnet MP, Marret E, Josserand J, Mercier FJ. Effect of prophylactic 5-HT3 receptor antagonists on pruritus induced by neuraxial opioids: a quantitative systematic review. Br J Anaesth. 2008 Sep;101(3):311-9. doi: 10.1093/bja/aen202. Epub 2008 Jul 7.
Clinical trial NCT04730245: Microbiota Modification for the Treatment of Motor Complication of Parkinson´s Disease
Official title: Targeting Gut Microbiota for Motor Complications in Parkinson´s Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease Aggravated
Keywords: Parkinson´s disease
Constipation
Dyskinesia
Microbiota
Lead sponsor: Torre Médica Santé
Sponsor class: NETWORK
First posted: 2021-01-29
Enrollment: 14
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: In recent years, abnormalities in gut microbiota have been identified in patients with Parkinson´s disease having a possible role in motor manifestations. Among 80 patients with PD, we selected 14 with LID and motor fluctuations with limited response to pharmacological therapy to receive treatment with sodium phosphate enema, oral rifaximin and polyethylene glycol to improve motor complications.

Detailed description: We studied consecutive patients diagnosed with PD according to the Queen Square Brain Bank Criteria \[Hughes et al 1992\] in a tertiary care center for movement disorders, from June 2018 to March 2020.

Eligibility criteria: Inclusion Criteria:

- patients aged 18-years old or older with moderate to severe dyskinesia and/or motor fluctuations with incomplete or poor response to adjustments in time and dose of levodopa and other anti-parkinsonian agents such as entacapone, rasagiline, dopamine receptor agonists and amantadine in 1-2 months prior to enrollment; defined by a Movement Disorders Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) part IV score equal or higher than 8 following pharmacological adjustments.

Exclusion Criteria:

* patients with chronic renal failure, decompensated heart failure, colonic abnormalities precluding the use of evacuating enema, known allergies to prescribed medications to reduce microbiota load and patients who declined to participate in the study.

Primary outcomes:
measure: Improvement in MDS-UPDRS-IV score
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: Torre Medica Sante
state: Guanajuato
Study officials:
affiliation: Torre Médica Sante
name: José Fidel Baizabal-Carvallo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02801045: Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient
Official title: Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Suffering
Advanced Cancers
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates from the patient's perspective which elements of the own artistic creative process are the source of a beneficial change for him/her and how those elements influence in their end of life experience.

Detailed description: In previous quantitative studies about the effect of an art therapy intervention in adult cancer inpatients of the Palliative Care Unit, the investigators evidenced significant improvements in the symptom control of malaise, anxiety, depression and pain.

This study is designed to deepen the understanding of specific action mechanisms which lead to those therapeutic benefits and quality of life implications for patients with life-threatening illness in which a situation of suffering is frequently detected.

The investigators will determine from the subjective patient's experience which specific elements of the artistic creative process (including production of art and art products) may lead to changes in the symptom perception, in meaning and healing process and in the personal perspective about the end of life situation.

Eligibility criteria: Inclusion Criteria:

* advanced-cancer adult inpatients of the Palliative Care Unit
* informed consent

Exclusion Criteria:

* altered cognitive function (Mini-Mental Test \< 24)
* physical decline (palliative care team's criteria) that impedes the art therapy process

Primary outcomes:
measure: Reflect Interview (RI) using audio recording.
timeFrame: After the making of a minimum of 5 art pieces, an average of 2 weeks
Secondary outcomes:
measure: Art therapy process from the art therapist perspective.
timeFrame: Every day of art therapy session, with an average of 2 sessions a week, over a period of 2 years.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Pau
Study officials:
affiliation: Palliative Care Unit, Sant Pau Hospital, Barcelona, Spain.
name: Antonio Pascual, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05538845: Comparison of Screw and Suture Button Technique Results in Ankle Syndesmosis Injuries
Official title: Comparison of Screw and Suture Button Technique Results in Ankle Syndesmosis Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Injuries
Syndesmotic Injuries
Tibiofibular; Dislocation Distal
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Maximum age (years): 91
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Comparison of 110 patients with screw or suture button method.

Brief summary: In this study, syndesmosis injuries were detected in 143 of the patients who came to Atatürk University Faculty of Medicine, Orthopedics and Traumatology clinic from October 2017 to October 2021 with ankle fractures. 33 of these patients couldn't followed for various reasons. Screw or suture buttone method was applied on 110 patients. And patients were examined with lots of data to compare their results. A retrospective study was conducted.


Eligibility criteria: Inclusion Criteria:

* Ankle fractures associated with syndesmotic injury
* Age group 19-91 years
* Dislocation or non-dislocation ankle fractures
* Fractures due to acute injury (less than 3 weeks)
* Patient compliance with follow-up

Exclusion Criteria:

* Patients younger than 18 years of age
* Conservative treatment
* Pathological and neglected fractures
* Patient's non-compliance with follow-up

Primary outcomes:
measure: angles of the joint range of motion
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University School of Medicine
Study officials:
References:
citation: Hennings R, Fuchs C, Spiegl UJ, Theopold J, Souleiman F, Kleber C, Ahrberg AB. "Flexible nature of fixation" in syndesmotic stabilization of the inferior tibiofibular joint affects the radiological reduction outcome. Int Orthop. 2022 Nov;46(11):2649-2657. doi: 10.1007/s00264-022-05550-7. Epub 2022 Aug 19.
citation: Hakverdiyev Y, McFarland EG, Kaymakoglu M, Ozdemir E, Akpinar S, Huri P, Costouros JG, Huri G. Biomechanical Strength of Screw Versus Suture Button Fixation in the Latarjet Procedure: A Cadaver Study. Orthopedics. 2022 Nov-Dec;45(6):e321-e325. doi: 10.3928/01477447-20220805-01. Epub 2022 Aug 10.
Clinical trial NCT06858345: Study of Maternal and Fetal Cardiovascular Function in Hypertensive States of Pregnancy
Official title: Study of Maternal and Fetal Cardiovascular Function in Hypertensive States of Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preeclampsia
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant patients undergoing regular hospital follow-up

Brief summary: The pharmacological treatment strategy is then tailored to the underlying hemodynamic phenotype of each patient. That is, rather than applying a one-size-fits-all treatment for all patients, therapy is tailored to the specific characteristics of how the cardiovascular system functions in each patient (e.g., whether the problem is more related to blood volume, vascular resistance, cardiac output, etc.). The goal is to personalize therapy to more effectively treat hypertensive states of pregnancy.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Women with singleton and twin pregnancies complicated by hypertensive states of pregnancy.

Exclusion Criteria:

* Minors under 18 years of age.
* Women with mental disabilities.
* Major congenital fetal anomaly.

Primary outcomes:
measure: Prolongation of at least one week of gestation in pregnancy complicated by hypertensive state of pregnancy with antihypertensive therapy guided by hemodynamic phenotypes
timeFrame: Up to 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: El Palmar
country: Spain
facility: HCUVA
state: Murcia
Study officials:
References:
Clinical trial NCT06684145: The Effect Of Kinesiotape Application In Chronic Low Back Pain
Official title: The Effect Of Kinesiotape Application On Clinical Parameters In Postmenopausal Women With Chronic Low Back Pain: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain (cLBP)
Keywords: Chronic low back pain
Kinesiotape
Sleep quality
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 60
Sex: FEMALE
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: This study was conducted to determine the effects of kinesiotaping (KT) and sham KT applied with exercise program on clinical parameters such as pain, sleep, and quality of life in postmenopausal women with chronic low back pain. A randomized controlled experimental design, characteristic of quantitative research, was utilized. The subjects consisted of 60 postmenopausal women. The Visual Analog Scale (VAS), Roland Morris Disability Questionnaire (RMDQ) and Pittsburgh Sleep Quality Index (PSQI) were used as data collection tools.

Detailed description: With rising life expectancy, women are expected to spend a third of their lives in the postmenopausal stage. Consequently, focusing research on postmenopausal women is considered crucial. This study was conducted to determine the effects of kinesiotaping (KT) and sham KT applied with exercise program on clinical parameters such as pain, sleep, and quality of life in postmenopausal women with chronic low back pain. A randomized controlled experimental design, characteristic of quantitative research, was utilized. The subjects consisted of 60 postmenopausal women. The Visual Analog Scale (VAS), Roland Morris Disability Questionnaire (RMDQ) and Pittsburgh Sleep Quality Index (PSQI) were used as data collection tools.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal patients with chronic nonspecific mechanical low back pain for at least three months
* VAS score of at least 3

Exclusion Criteria:

* Patients with a neurologic deficit, history of lumbar surgery, inflammatory low back pain, spinal stenosis, spondylolisthesis, a history of cardiopulmonary disease preventing exercise, severe osteoporosis, or a skin infection in the application area

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: up to 48 hours
Secondary outcomes:
measure: Pittsburgh sleep quality index
timeFrame: up to 48 hours
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Muhammet Şahin Elbastı
state: Elazig
Study officials:
References:
Clinical trial NCT03566745: Elucidating the Molecular and Biochemical Basis of the Human AhR-mutation Disease
Official title: Elucidating the Molecular and Biochemical Basis of the Human AhR-mutation Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mutation, Point
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-06-25
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Everyone

Brief summary: In a previous study, we have identified a consanguineous family from Northern Israel with three children affected by idiopathic infantile nystagmus (IIN) and foveal hypoplasia, which follow an autosomal recessive mode of inheritance of AhR gene. in this study we will determine whether the disease phenotype is the consequence of a decrease in or absence of AHR-induced AHH activity

Detailed description: In a previous study, we have identified a consanguineous family from Northern Israel with three children affected by idiopathic infantile nystagmus (IIN) and foveal hypoplasia, which follow an autosomal recessive mode of inheritance of AhR gene. in this study we will:

1. To determine whether the disease phenotype is the consequence of a decrease in or absence of AHR-induced AHH activity. To this end, basal and ligand-mediated AHH enzyme activity will be compared in heterozygotic and homozygotic family members versus healthy volunteers.
2. To examine steady state protein levels of the AHR protein in cells of homo- and heterozygotic patients versus those of healthy volunteers. If no mutant protein is detected, we will determine the effect of the mutation on mRNA stability.
3. To analyze steady state levels of related partner proteins (such as ANRT) and proteins levels of transcriptional targets (AHH) in heterozygotic and homozygotic family members versus healthy volunteers.
4. To investigate the ability of the mutant allele to induce transcriptional activation in an engineered yeast test system. We will use a yeast strain engineered to contain human AHR and AHR nuclear translocator together with a reporter gene to investigate whether the mutation interferes with transcription activation.

Eligibility criteria: Inclusion Criteria:

* patients with mutation in AhR gene

Exclusion Criteria:

* None

Primary outcomes:
measure: Low protein activity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hillel Yaffe mediacl center
name: Muhammad Mahajnah, MD PhD
role: STUDY_CHAIR
References:
citation: Juricek L, Carcaud J, Pelhaitre A, Riday TT, Chevallier A, Lanzini J, Auzeil N, Laprevote O, Dumont F, Jacques S, Letourneur F, Massaad C, Agulhon C, Barouki R, Beraneck M, Coumoul X. AhR-deficiency as a cause of demyelinating disease and inflammation. Sci Rep. 2017 Aug 29;7(1):9794. doi: 10.1038/s41598-017-09621-3.