louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04618575: Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
Official title: A Randomized Controlled Open-label Clinical Trial of Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis
Primary Biliary Cholangitis
Autoimmune
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of PBC with AIH features 1


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18-75 years;
2. The diagnosis of PBC is clear and does not meet the Paris criteria for diagnosing PBC overlap AIH, but it needs to meet 1.0xULN \< ALT ≤ 3.0xULN or 1.0xULN \< AST ≤ 3.0xULN or 1.0xULN \< IgG ≤ 1.3xULN, and liver pathological biopsy excludes moderate or higher interface inflammation;
3. Agreed to participate in the trial, and assigned informed consent.

Exclusion Criteria:

1. The presence of hepatitis A, B, C, D, or E virus infection;
2. Patients with presence of cirrhosis;
3. Patients with presence of fulminant liver failure;
4. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease;
5. Pregnant and breeding women and women of childbearing age in need of reproduction;
6. Severe disorders of other vital organs, such as severe heart failure, cancer;
7. Parenteral administration of blood or blood products within 6 months before screening;
8. Recent treatment with drugs having known liver toxicity;
9. Taken part in other clinic trials within 6 months before enrollment.

Primary outcomes:
measure: Biochemical remission
timeFrame: up to 12 months
Secondary outcomes:
measure: Partial remission
timeFrame: up to 12 months
measure: Minimal response
timeFrame: up to 12 months
measure: Treatment failure
timeFrame: up to 12 months
measure: Side-effects
timeFrame: up to 12 months
measure: Clinical symptoms
timeFrame: up to 12 months
measure: Changes in the proportion of blood immune cells
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Li Yang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04391075: Analgesia in the Second Stage of Labour
Official title: Analgesia in the Second Stage of Labour - With Special Focus on Pudendal Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childbirth Experience
Urinary Retention
Satisfaction, Personal
Pain, Obstetric
Keywords: Pudendal nerve block
Urine and urination
Anesthetics
Peripheral nervous system agents
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 1007
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants is selected from 2 delivery units at Oslo Univeristy Hospital (OUH) in Oslo, Norway. OUH is a third referral hospital, the largest Obstetrics Dept. in Norway, and accounting for 1/6 of all deliveries in Norway (9600 deliveries/year).

Brief summary: This study investigates efficacy, safety and childbirth experience in women receiving pudendal block during the final stage of delivery. It is an observational study and half of included primarous women recieve a pudendal block.

Detailed description: Pudendal block is used when there is a need to alleviate pain in the final stage of labour:

* From fully dilated cervix to delivery of the child.
* Associated with pain as the foetus rotates and descends through the pelvis.
* End of second stage: the perineum dilates as the child is being born.

Pudendal block is provided by inserting a needle close to the pudendal nerve that runs through the pelvis and innervates the perineal area.Pudendal block is an old and relatively simple method, but not well studied. The main aim is to study pudendal nerve block as pain relief in final stage of labour for primiparous women delivering vaginally.

The investigators aim to investigate whether possible adverse effects may outweigh the positive analgesic effect in the final stage of labour, or the opposite. The ASL (Analgesia in the Second stage of Labour) study may fill knowledge gaps and add important knowledge regarding pain relief during the final stage of childbirth.

Eligibility criteria: Inclusion Criteria:

* Norwegian-speaking/reading
* Primiparity
* Single pregnancy
* Vaginal birth
* Cephalic presentation
* ≥37+0
* Age ≥18 years

Exclusion Criteria:

* Transferre from midwifery-led birth unit
* Allergy to local anaesthesia
* Not valid data on pudendal block

Primary outcomes:
measure: Childbirth experience
timeFrame: Responds to questionnaire 4-12 weeks after delivery.
measure: Urinary retention
timeFrame: 3 hours
Secondary outcomes:
measure: Pain, obstetric
timeFrame: Responds to questionnaire 4-12 weeks after delivery.
Other outcomes:
Locations:
Study officials:
affiliation: Univeristy of Oslo
name: Anne Flem Jacobsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04842175: Evaluation of Education and Equipment in the Prehospital Setting
Official title: Evaluation of Education and Equipment of Paramedics in the Prehospital Setting. A Online Based Survey. The EVAIR-Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Disease
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 1400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy paramedics in Germany

Brief summary: In a national online based survey the investigators are targeting paramedics for these survey that are involved in prehospital setting. In this study the investigators want to get more information about the current standard or levels of education in prehospital emergency medicine (e.g. airway management) and the incidence of the independently application in daily practice. Furthermore the investigators want to know the current hygiene concepts especially in the actual SARS-CoV-2 Pandemic.

Detailed description: Every participant can answer the survey just once.

Eligibility criteria: Inclusion Criteria:

* Male and Female participants/paramedics

Exclusion Criteria:

* None

Primary outcomes:
measure: Perception of intubation success
timeFrame: through study completion, on average 1 Month
Secondary outcomes:
measure: Perception of hygiene concepts in SARS-CoV-2 Pandemic
timeFrame: through study completion, on average 1 Month
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
state: Rhineland-Palatinate
Study officials:
affiliation: University JG, Mainz
name: Marc Kriege, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03507075: Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility
Official title: Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. The goal of this feasibility study is to determine if using technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed breathalyzer is an effective treatment that is acceptable to participants. If validated, this treatment approach has the potential to facilitate the dissemination of an effective, evidence-based treatment for alcohol dependence to a broader population whose treatment needs are not currently being adequately met.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Provide written informed consent
* Meet Diagnostic and Statistical Manual criteria for alcohol use disorder
* Express a desire to cut down or quit drinking

Exclusion Criteria:

* Pregnant or lactating
* Meet Diagnostic and Statistical Manual criteria for other substance use disorder (except caffeine or nicotine)
* Score 23 or greater on the Alcohol Withdrawal Symptom Checklist
* Have immediate plans to move out of the area

Primary outcomes:
measure: Percent days abstinent from alcohol during intervention
timeFrame: Percent days abstinent is the aggregate measure throughout the 21-day intervention period
measure: Treatment acceptability
timeFrame: Baseline, one day after treatment end, and at a one-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04444375: Plantar Pain, Balance and Foot Function in Individuals With Diabetes Mellitus
Official title: Plantar Pain, Balance and Foot Function in Individuals With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
plantar pain
body mass index
obesity
balance
foot pain
disability
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 54
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetes Mellitus

Brief summary: Diabetes Mellitus (DM) and increase of body mass index (BMI) are two one of the most common risk factors for plantar pain and related disability. The aim of our study was to evaluate the relationship between plantar pain, balance and foot function in diabetic DM patients has with different BMI.


Eligibility criteria: Inclusion Criteria:

* having plantar pain
* and no change in BMI by more than 10% for at least 3 months
* being volunteer to participate to the study

Exclusion Criteria:

* having musculoskeletal surgery for foot
* having neurological, orthopedic, and cardiovascular diseases
* vision and hearing problems that may cause balance disorder

Primary outcomes:
measure: the Portable Computerized Kinesthetic Equilibrium Device (SportKAT 550)
timeFrame: 6 months
measure: Foot Function Index
timeFrame: 6 months
measure: Manchester Foot Pain and Disability Index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Mehmet Duray
Study officials:
affiliation: Suleyman Demirel University
name: Mehmet Duray
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06302075: Functional Recovery After Medial Monocompartmental Knee Prosthesis: One Day Protocol Versus Fast Protocol
Official title: Evaluation of Functional Recovery of Patients Undergoing Medial Monocompartmental Knee Prosthesis With One Day Protocol Versus Fast Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gonarthrosis
Keywords: Gonarthrosis
rehabilitation
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B).

Detailed description: The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B).

The difference will be evaluated with the Knee Society Scopre (KSS) questionnaire at 1 month after the operation.

The population is made up of two groups of patients:

25 patients Group A: one day protocol; experimental group discharged home the day (24h) after the operation and carrying out rehabilitation according to the clinical standard 25 patients Group B: fast protocol; control group discharged to the rehabilitation department of the Institute 48 hours after surgery which carries out rehabilitation during the hospital stay according to the clinical standard

The subjects will undergo the following assessments:

* Pre-admission
* Knee replacement surgery
* Rehabilitation
* Questionnaires and evaluation scales at 7 and 15 days (+/- 2 days), at 1, 3, 6 months (+/- 7 days) and 12 months (+/- 1 month) after surgery. If necessary, they can be collected by telephone.

Eligibility criteria: Inclusion Criteria:

* Age 40\<x\<85 included
* Medial monocompartmental gonarthrosis grade 3-4 sec Kellgren-Lawrence
* Primary medial gonarthrosis
* Signing of the Informed Consent and consent to collaborate in all study procedures.

Exclusion Criteria:

* Cognitive decline
* Psychiatric disorders
* Neuromuscular disorders
* Age \> 85 years or \<40
* Lateral gonarthrosis grade 3-4 sec Kellgren-Lawrence
* Patella symptoms
* Secondary medial gonarthrosis
* Minor age
* Pregnant women (self-declaration)

Primary outcomes:
measure: Knee Society Score (KSS) from 0 to 100 (whether higher scores mean a better outcome)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Clinico San Siro
state: Italia
Study officials:
References:
Clinical trial NCT06256575: Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis
Official title: Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Scleroderma, Systemic
Digital Ulcer
Keywords: SSc
Digital Ulcers
Sclerosis
Scleroderma
Lead sponsor: Primus Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2024-02-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a parallel study of two (2) arms in which participants receive different interventions. Participants are randomized and assigned to the treatment or placebo arm at the beginning of the trial. They continue in that arm throughout the length of the trial.
Primary purpose: TREATMENT

Brief summary: This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). Two (2) out of three (3) participants will receive active product. The participants will have four (4) visits over eight (8) weeks. Physical exams and photos will be performed. A variety of questions will be asked describing level of pain and lifestyle changes.

Detailed description: This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). The study will include 21-45 participants randomly given active product or inactive product (placebo). Two (2) out of every three (3) participants enrolled will receive active product. The participants will have four (4) visits over eight (8) weeks. At each visit physical exams and photos will be performed. Each person will also be asked a variety of questions describing level of pain and any changes to their lifestyle.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of systemic sclerosis (scleroderma)
* At least one "active" digital ulcer
* Medication for systemic sclerosis unchanged for 30 days

Exclusion Criteria:

* Infection or gangrene in ulcer
* Citrus allergy
* Unstable heart, kidney, or liver disease
* Active infection of any type
* Current cancer treatment or uncured cancer
* Pregnancy or breast feeding

Primary outcomes:
measure: Efficacy - Number (%) of healed baseline ulcers
timeFrame: Screening, Day 1, Day 28, Day 56
Secondary outcomes:
measure: Safety - number of adverse events
timeFrame: Screening, Day 1, Day 28, Day 56
Other outcomes:
Locations:
Study officials:
affiliation: Primus Pharmaceuticals
name: Lukban
role: STUDY_DIRECTOR
References:
Clinical trial NCT02957175: Immunophenotyping of Patients With Postoperative SIRS
Official title: Immunophenotyping of Patients Undergoing Open Heart Surgery to Assess Their Susceptibility of Developing a Systemic Inflammatory Response Syndrome (SIRS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Inflammatory Response Syndrome
Keywords: Immunophenotyping
Perioperative Care
Innate Immunity
Cardiac Surgical Procedures
Lead sponsor: University of Bonn
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing open heart surgery.

Brief summary: The purpose of this study is to develop an immune-phenotype based prediction of postoperative SIRS in patients undergoing open heart surgery.

Detailed description: The study will have a pre-, intra and postoperative phase in which several demographic and clinical variables will be assessed. The samples for the immunophenotypic analysis will be drawn directly after induction of anesthesia and at various time points after end of surgery. The diagnosis of SIRS will be made during routine clinical visits on the first seven postoperative days using the Sepsis-related Organ Failure Assessment score (SOFA-score). The patients will be followed up for 30 days.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Informed consent of the patient
* Patient undergoing a open heart surgery using a cardiopulmonary bypass

Exclusion Criteria:

* Age \< 18 years
* Missing informed consent
* Renal failure
* Liver failure
* Neurodegenerative disease
* Malignancies
* Immune therapy

Primary outcomes:
measure: Number of participants with SIRS as assessed by SOFA-Score
timeFrame: 30 days
Secondary outcomes:
measure: Number of participants with need for renal replacement therapy because of acute kidney failure (AKIN classification)
timeFrame: 30 days
measure: Number of participants with infection as assessed by microbiological, serological and radiological examination
timeFrame: 30 days
measure: Number of participants with postoperative delir as assessed by CAM-ICU
timeFrame: 30 days
measure: Number of participants with myocardial injury as assessed by troponine and CK-MB serum levels
timeFrame: 30 days
measure: Number of participants with new atrial fibrillation as assessed by ECG
timeFrame: 30 days
measure: Length of stay in ICU
timeFrame: 30 days
measure: Length of stay in hospital
timeFrame: 30 days
measure: In-hospital mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
Study officials:
affiliation: Institute of Innate Immunity
name: Eicke Latz, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Anesthesia and Critical Care Medicine
name: Christian Bode, MD
role: STUDY_CHAIR
affiliation: Department of Anesthesia and Critical Care Medicine
name: Folkert M Steinhagen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01746875: A Study Testing if Medicine Can Make Pigment Epithelium Detachments Regress and Stabilize the Vision in Eyes
Official title: Pigment Epithelium Detachment - a Prospective Clinical Study. PED-study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Macular Degeneration
Retinal Detachment
Keywords: Angiogenesis inhibitors
Photochemotherapy
Vascular Endothelium Growth Factors
Aflibercept
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 9
Sex: ALL
Minimum age (years): 50
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 determine treatment effects in patients with retinal pigment epithelium detachment (PED) in relation to Age Related Maculopathy (AMD). Patients with newly diagnosed PED without choroidal neovascularisations (CNV), will be randomized to either treatment or observation. The treatment group will first be given injections with anti Vascular Endothelium Growth Factor (anti-VEGF). If the injections do not have any effect, Verteporfin Photodynamic Therapy (PDT) will be given. All patients will be followed for a period of 2 years. It is hypothesized that treatment stops the progression of the disease and stabilizes the vision in this subgroup of patients with AMD.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 50 years
* Pigment epithelium detachment in an eye not earlier treated with anti-VEGF or verteporfin PDT.
* ETDRS Best Corrected Visual acuity 20/32 - 20/400

Exclusion Criteria:

* Prior treatment with verteporfin, or external-beam radiation therapy, or transpupillary thermotherapy, Previous subfoveal focal laser photocoagulation involving the foveal center, History of vitrectomy, submacular surgery, or other surgical intervention for AMD.
* CNV, Subfoveal fibrosis or atrophy in study eye.
* Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma) or require medical or surgical intervention during the study. Active intraocular inflammation in the study eye.

Primary outcomes:
measure: Mean change in visual acuity from baseline to 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Visual acuity from baseline to 6 months
timeFrame: 6 months
measure: Visual acuity from baseline to 12 months
timeFrame: 12 months
measure: Safety
timeFrame: 24 months
measure: Change in Optical Coherence Tomography (OCT) measurements from baseline through 24 months
timeFrame: 24 months
measure: Development of choroidal neovascularisations (CNV)
timeFrame: 24 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Neuroscience, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Tor Elsaas, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: