louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06287606: A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy
Official title: A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Preparation
Keywords: bowel preparation
Lead sponsor: Taejoon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-01
Enrollment: 161
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy

Detailed description: This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Patients must provide written informed consent.
* Male and female outpatients and inpatients aged: ≥19
* Patients BMI shoule be ≤ 30

Exclusion Criteria:

* Patients with past history of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
* Patients with ongoing severe acute Inflammatory Bowel Disease.
* Patients who have had previous significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection, defunctioning colostomy.
* Pregnant women or pregnant women or pregnant women
* Severe heart disease (cardiac failure (NYHA class 3 and 4))
* Acute coronary artery disease within 24 weeks before screening (an unstable angina pectoris, acute myocardial infarction), clinically significant arrhythmia, hypertrophic obstruction Cardiomyopathy, valvular disease, aortic and peripheral vascular diseases.
* People who have hypersensitivity or allergies to clinical trial drug components.

Primary outcomes:
measure: Ratio of subjects With successful Bowel Cleansing
timeFrame: 1 day of scheduled colonoscopy
Secondary outcomes:
measure: Each segments ratio of subject with successful Bowel Cleansing
timeFrame: 1 day of scheduled colonoscopy
Other outcomes:
measure: Comparison of Acute gastropathy probability score
timeFrame: 1 day of scheduled colonoscopy
Locations:
city: Seoul
country: Korea, Republic of
facility: Taejoon Pharmaceutical Co., Ltd.
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong
name: Jaemyung Cha, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06409806: Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)
Official title: Electrocorticography As a Neurophysiological Marker for Intraoperative Monitoring for Brain Retraction: an IDEAL Stage 1 Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Injury
Neurosurgery
Brain Ischemia
Keywords: Brain retraction
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 6
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A single centre IDEAL Stage 1 feasibility study using novel electrophysiological recording techniques in adult participants undergoing neurosurgery. This is a first in human study, building upon previous preclinical mice experiments.

Participants will undergo their planned neurosurgical procedure as normal. In addition to their standard treatment neurophysiological monitoring including an electrocorticography electrode placed on the brain deep to the retractor will be used to monitor for signs of brain retraction injury.


Eligibility criteria: Inclusion Criteria:

* Patients aged 16 or older undergoing intracranial surgery where it is anticipated fixed brain retraction will be used.

Exclusion Criteria:

* Patients without capacity to give consent at time of recruitment

Primary outcomes:
measure: Evaluate the feasibility of integrating the ECoG brain retractor into standard traditional neurosurgical operative workflow.
timeFrame: Over a 28 month period from November 2022 to March 2026
Secondary outcomes:
measure: Analyse the captured electrophysiological data to investigate any correlation between the electrophysiological signature and duration of retraction.
timeFrame: Over a 28 month period from November 2022 to March 2026
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: National Hospital Neurology and Neurosurgery
state: Greater London
Study officials:
References:
Clinical trial NCT01927406: The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
Official title: The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Thyroid Eye Disease
Ocular Hypertension
Glaucoma
Keywords: Thyroid Eye Disease
Graves' Disease
Prostaglandin Analogues
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-08-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the potential secondary beneficial effect of prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims to determine if PA would change the course of the orbitopathy in TED patients by altering the progression of the common features of TED, including fatty hypertrophy, proptosis, eyelid retraction and optic nerve compression. The eyes with thyroid eye disease and elevated intraocular pressure will be randomised to the PA treatment and the other eye will serve as a control eye and will be treated with Timolol.


Eligibility criteria: Inclusion Criteria:

* mild or moderate to severe thyroid eye disease in one or both eyes
* age \> 18 years
* informed consent
* intraocular pressure \> 21 mmHg or glaucoma suspect or glaucoma diagnosed in one or both eyes
* not on current prostaglandin analog intraocular pressure lowering therapy

Exclusion Criteria:

* sight threatening thyroid eye disease
* children \< 18 years old
* patients that are not compliant with treatment or follow-up
* patients already on prostaglandin analog treatment
* patients that undergo cosmetic periocular procedures during the study will be excluded from further follow up
* patients that cannot tolerate prostaglandin analog treatment.
* patients with bilateral thyroid eye disease and elevated intraocular pressures that cannot tolerate treatment with timolol or an alternative intraocular pressure lowering medication such as trusopt, combigan, cosopt.

Primary outcomes:
measure: Change from baseline in appearance of facial periorbital region at 6 months.
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change from baseline in Hertel exophthalmometry at 3, 6, 9 and 12 months.
timeFrame: Baseline and 3, 6, 9 and 12 months
measure: Change from baseline in intraocular pressure at 3, 6, 9 and 12 months.
timeFrame: Baseline and 3, 6, 9 and 12 months
measure: Change from baseline in appearance of facial periorbital region at 3, 6, 9 and 12 months.
timeFrame: Baseline and 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Andrea L. Kossler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00266006: Factor VIIa in Acute Intracerebral Haemorrhage
Official title: Safety of Eptacog Alfa (Activated) (Genetical Recombination) on Adverse Events and Serious Adverse Events in Patients With Acute Intracerebral Haemorrhage.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acquired Bleeding Disorder
Intracerebral Haemorrhage
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-12-15
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute intracerebral haemorrhage.


Eligibility criteria: Inclusion Criteria:

* Spontaneous ICH

Exclusion Criteria:

* Time of ICH onset \> 3 hours
* Patients with secondary ICH
* Pre-existing disability
* Hemophilia

Primary outcomes:
measure: The Occurrence of thromboembolic serious adverse event
timeFrame: Until 90 days
Secondary outcomes:
measure: Reducing disability and improving clinical outcome
measure: Reducing haematoma growth
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02235506: A Comparison of Epidural Block With Adding Sciatic Block to Continuous Femoral Block in Total Knee Arthroplasty
Official title: A Comparison of Epidural Analgesia With Adding Sciatic Nerve Block to Continuous Femoral Nerve Block for Post-operative Pain Management Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators compared continuous epidural infusion with combined continuous femoral and single-shot sciatic nerve blocks. The primary outcome was the incidence of side effects, and secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation indices.

Detailed description: The parcicipants were randomly assingned to epidural infusion group and femoral sciatic block. In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation. In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr. The incidence of side effects is measured.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Physical Status Classification I-II
* total knee arthroplasty
* 18-90 years

Exclusion Criteria:

* allergic to the local anesthetics
* cognitive impairment such as dementia
* coagulopathy
* motor and sensory impairment
* patient refusal
* BMI \>39

Primary outcomes:
measure: the incidence of side effects
timeFrame: during 5 days after the end of operation
Secondary outcomes:
measure: Pain
timeFrame: during 5 days after the end of operation
measure: Motor blockade at rest and on mobilization
timeFrame: during 5 days after the end of operation
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
name: Sangjin Park, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04247906: Single Patient Expanded Access Treatment Plan For The Investigational Product Narsoplimab
Official title: Single Patient Expanded Access Treatment Plan (EAP; Also Known As A Compassionate Use Plan) To Provide Patients Access To The Investigational Product Narsoplimab
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Hematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA)
Lead sponsor: Omeros Corporation
Sponsor class: INDUSTRY
Collaborators: name: Impatients N.V. trading as myTomorrows
First posted: 2020-01-30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of the EAP is to provide access to hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) patients who may benefit from treatment with narsoplimab based on the medical judgement of their respective physicians.


Eligibility criteria: * Patient (adult or pediatric) must have undergone allogeneic or autologous hematopoietic stem cell transplant (HSCT)
* Patient must be capable of understanding an informed consent form (ICF) or the parent or legal guardian of the patient is able to understand and sign a written ICF prior to the initiation of any treatment procedures.
* Patient must have HSCT- TMA defined as having thrombocytopenia and evidence of microangiopathic hemolytic anemia.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01560806: Intervention Study on Hypertension Management Combined With Health Promotion at Commune Level
Official title: Quasi-experimental Intervention Study on Hypertension Management Combined With Comprehensive Healthy Lifestyle Promotion at Commune Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Risk Factor
Lifestyle
Keywords: hypertension
cardiovascular risk factor
lifestyle
Lead sponsor: Vietnam National Heart Institute
Sponsor class: OTHER_GOV
First posted: 2012-03-22
Enrollment: 2400
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A quasi-experimental study design was chosen to compare the model of hypertension management at commune-level with conventional management for people with high blood pressure in two communes (one for intervention versus one for reference).

A intervention model included the commune-based programme on hypertension management combined with comprehensive health promotion campaigns

Detailed description: A quasi-experimental study design was chosen: two communes were purposively selected from Ba-Vi setting: Phu-Phuong for reference and Phu-Cuong for intervention communes A hypertension management programme and the nested comprehensive health promotion campaigns were implemented simultaneously in Phu-Cuong while nothing performed in Phu-Phuong except for local conventional healthcare services.

The health promotion campaigns aimed at smoking cessation, reduction of alcohol consumption, encourage of unsalted diet and physical activity, all of which targeted to every local inhabitants.

The hypertension management programme focused on monthly check-ups, drug delivery and individual lifestyle consultation, all of which targeted to hypertensives only.

Baseline cross-sectional survey was used to assess cardiovascular pattern in local community before intervention and recruit people with high blood pressure for the management programme in intervention commune Repeated cross-sectional surveys were used to evaluate the impacts of health promotion.

Cohort study on hypertensives was used to evaluate the impacts of the management programme.

Eligibility criteria: Inclusion Criteria:

* Adult people above 25

Exclusion Criteria:

* People deny to join the study

Primary outcomes:
measure: Proportion of people with high blood pressure receiving treatment and being controlled in intervention commune
timeFrame: Baseline and after 3-year
Secondary outcomes:
measure: Changes in prevalences of behavioral cardiovascular risk factors in intervention commune
timeFrame: Baseline and after 3-year
measure: Changes in average blood pressure in the population in intervention commune
timeFrame: Baseline and after 3 years
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vietnam National Heart Institute
Study officials:
affiliation: Vietnam National Heart Institute
name: Son T. Pham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01303406: Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI)
Official title: A Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study of Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Friedreich's Ataxia
Keywords: randomized withdrawal
idebenone
friedreich's ataxia
Miconos
Patient reported outcome
ICARS
Lead sponsor: Santhera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-02-24
Enrollment: 29
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study. The aim is to further investigate the effects of idebenone in patients with Friedreich's ataxia.

The objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment (placebo or idebenone) they received during the randomised phase of the trial, and identify any potential changes on symptoms or activities.


Eligibility criteria: Inclusion Criteria:

* Completion of V5 (Month 12), V6 (Month 18), or V7 (Month 24) in the MICONOS extension study
* Patients who in the opinion of the investigator are able to comply with the requirements of the study
* Body weight ≥ 25kg
* Negative urine pregnancy test

Exclusion Criteria:

* AE during the course of the MICONOS extension study which in the opinion of the investigator is attributable to idebenone and precludes further treatment with idebenone
* Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal SGOT, SGPT or creatinine
* Parallel participation in another clinical drug trial
* Pregnancy or breast-feeding
* Abuse of drugs or alcohol
* Any change of concomitant medication within the last 30 days that in the opinion of the investigator the intake could negatively impact the study

Primary outcomes:
measure: Patient Assessment of Treatment Assignment: Comparison of the Proportions of Patients Randomised to Idebenone and Placebo Who Assessed That They Received Idebenone
timeFrame: At 2 months after study start
Secondary outcomes:
measure: Comparison of the Percentage of Participants Randomised to Idebenone and Placebo Who Withdrew Early Due to Recurrence or Worsening of FRDA Symptoms
timeFrame: Within 2 months (i.e. Early withdrawal visit)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Bonn
country: Germany
city: München
country: Germany
city: Tübingen
country: Germany
city: Groningen
country: Netherlands
city: London
country: United Kingdom
facility: The National Hospital, University College London
Study officials:
affiliation: Institute of Neurology, The National Hospital, University College London
name: Paola Giunti, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06837506: Ultrasound Guided Rectus Sheath Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Open Total Abdominal Hysterectomy
Official title: Ultrasound Guided Rectus Sheath Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Open Total Abdominal Hysterectomy: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ultrasound
Rectus Sheath Block
Intrathecal Morphine
Postoperative Analgesia
Total Abdominal Hysterectomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 80
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 aims to compare the effectiveness and safety of ultrasound-guided rectus sheath block versus intrathecal morphine for postoperative analgesia in patients undergoing open total abdominal hysterectomy.

Detailed description: Effective postoperative analgesia is crucial for enhancing recovery and patient satisfaction following major surgical procedures, such as total abdominal hysterectomy (TAH).

Rectus sheath block (RSB), an ultrasound-guided regional anesthesia technique, involves the injection of local anesthetic into the rectus sheath, providing analgesia to the anterior abdominal wall. RSB is used to block the sensory nerves of the anterior abdominal wall and thereby contributing to pain relief after lower abdominal surgeries.

Intrathecal morphine (ITM) provides a highly effective method of analgesia by delivering the medication directly into the cerebrospinal fluid (CSF).

Eligibility criteria: Inclusion Criteria:

* Age: 18 - 65 years old.
* American Society of Anesthesiologists (ASA) physical status (I -II).
* Patients undergoing open total abdominal hysterectomy.

Exclusion Criteria:

* Hepatic, renal, or cardiac disease.
* Any known allergy to local anesthetic.
* Physical or mental conditions which may vague measuring postoperative pain following surgery.
* History of chronic use of analgesic as nonsteroidal anti-inflammatory drugs (NSAIDs) or central nervous system (CNS) depressants as antiepileptic, and bleeding disorders.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Time to the first request for the rescue analgesia
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Degree of sedation
timeFrame: Intraoperatively
measure: Degree of patient satisfaction
timeFrame: 24 hours postoperatively
measure: Time of hospital discharge
timeFrame: 28 days postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: