louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06009393: Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
Official title: A Single-Arm, Open-Label, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Homozygous Familial Hypercholesterolemia
Lead sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-08-24
Enrollment: 20
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 single-arm, open-label study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia (HoFH).


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol
2. LDL-C ≥2.6mmol/L at the screening visit
3. Body weight ≥40 kg
4. Receiving stable lipid-lowering therapy for at least 28 days before enrollment.

Exclusion Criteria:

1. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%)
2. eGFR \<30ml/min/1.73m2 at the screening visit
3. CK \>5times ULN at the screening visit

Primary outcomes:
measure: Percent change in calculated LDL-C from baseline to week 12
timeFrame: from baseline to week 12
Secondary outcomes:
measure: Change in calculated LDL-C from baseline to week 12
timeFrame: from baseline to week 12
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04379193: Physical Therapy and Neuroactive Steroids Therapy Does Not Modulate Serum Level of Neuroactive Steroids
Official title: Ambulatory Neuroproprioceptive Facilitation and Inhibition Physical Therapy Does Not Modulate Serum Level of Neuroactive Steroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: neuroactive steroids
physical therapy
dehydroepiandrosterone
cortisol
multiple sclerosis
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 63
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: This study describes modulation of neuroproprioceptive facilitation and inhibition physical therapy on serum level of neuroactive steroids in multiple sclerosis.

Detailed description: In the parallel group, single blind, randomized controlled trial, participant underwent two kinds of neuroproprioceptive PT (MPAT and VRL). At baseline and after the end of the two months' therapeutic program, a blinded assessor evaluated clinical outcomes and data from serum level.

Eligibility criteria: Inclusion Criteria:

* prevailed spastic paraparesis, stable clinical status and treatment in the preceding 3 months determined by neurologist,
* Expanded Disability Status Scale score (EDSS) max. 7.5

Exclusion Criteria:

* other neurological disease or conditions disabling movement

Primary outcomes:
measure: serum level of neuroactive steroids
timeFrame: 2 months
Secondary outcomes:
measure: Berg Balance Scale, BBS outcomes
timeFrame: 2 months
measure: Paced Auditory Serial Addition Test
timeFrame: 2 months
measure: the 29-item Multiple Sclerosis Impact Scale, MSIS -29
timeFrame: 2 months
measure: Modified Fatigue Impact Scale
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Third Faculty of Mecicine, Charles Univerzity
name: Kamila Řasová, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Angelova G, Skodova T, Prokopiusova T, Markova M, Hruskova N, Prochazkova M, Pavlikova M, Spanhelova S, Stetkarova I, Bicikova M, Kolatorova L, Rasova K. Ambulatory Neuroproprioceptive Facilitation and Inhibition Physical Therapy Improves Clinical Outcomes in Multiple Sclerosis and Modulates Serum Level of Neuroactive Steroids: A Two-Arm Parallel-Group Exploratory Trial. Life (Basel). 2020 Oct 31;10(11):267. doi: 10.3390/life10110267.
Clinical trial NCT01541293: Intrauterine Lidocaine for Laminaria
Official title: Intrauterine Lidocaine for Pain Control During Laminaria Insertion Prior to Dilation & Evacuation (D&E)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Abortion, Induced
Pain Management
Keywords: Abortion, Induced
Laminaria
Pain management
Cervical preparation
Dilation and Evacuation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 72
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: This is a study to investigate whether instilling a small amount of liquid lidocaine into the uterus will decrease pain felt by women during laminaria insertions done for cervical dilation prior to second trimester abortion.

The investigators hypothesize that women who receive intrauterine lidocaine in addition to a paracervical block will experience less pain than women who receive only a paracervical block.


Eligibility criteria: Inclusion Criteria:

* Can sign informed consent
* Healthy pregnant females
* Weight over 45kg
* Seeking abortion by dilation and evacuation in the second trimester of pregnancy
* Gestational age 14-24 weeks confirmed by clinic ultrasound

Exclusion Criteria:

* Known allergy or previous reaction to lidocaine, bupivicaine or other anesthetic agent
* Known allergy or previous reaction to ibuprofen or other NSAID

Primary outcomes:
measure: Patient self-report of pain score during laminaria insertion, scored on a 100mm Visual Analog Scale
timeFrame: Immediately following laminaria insertion
Secondary outcomes:
measure: Patient self-report of maximum recalled pain during interval between laminaria insertion and abortion procedure, scored on a 100mm Visual Analog Scale
timeFrame: 24-48 hours after laminaria insertion
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Rebecca J Mercier, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.
Clinical trial NCT06382493: Tegoprazan-containing Sequential for H. Pylori
Official title: Efficacy of Tegoprazan-containing Sequential Therapy Compared to Proton Pump Inhibitor-based Eradication in South Korea, a Region With High Antimicrobial Resistance: A Prospective Randomized Single Tertiary Center Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Helicobacter Pylori Infection
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy

Detailed description: Eradication treatment containing potassium-competitive acid blocker has shown acceptable eradication efficacy. In regions such as Korea, where the prevalence of antimicrobial resistance is high, alternative combinations of antibiotics such as sequential or concomitant therapy are needed. This study compared the outcome of sequential therapy containing tegoprazan, a new potassium-competitive acid blocker, with the conventional esomeprazole-containing sequential therapy.

Eligibility criteria: Inclusion Criteria:

Patients who had H. pylori infection proved by positive test result of urea breath test (UBT), rapid urase test or pathologic examination (warthin-giemsa staining)

Exclusion Criteria:

* congestive heart failure, NYHA III or IV
* end-stage renal disease
* alcoholics
* drug abusers
* pregnant or nursing women

Primary outcomes:
measure: Eradication rate
timeFrame: 2 or 3 month
Secondary outcomes:
measure: Adverse events
timeFrame: up to 6 month
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Nayoung Kim, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05857293: PDA Stent in Neonates With PDA Dependent Pulmonary Circulation
Official title: Outcomes for Patent Ductus Arteriosus Stenting in Neonates With Duct-Dependent Pulmonary Circulation: A Prospective Study at Sohag University Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Cyanosis Due to PDA Dependent Pulmonary Circulation
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: After echocardiography confirmation of PDA dependent pulmonary circulation in cyanotic neonates, catheter-guided PDA stent implantation will be done. Under general Anasthesia and after discontinuation of prostaglandin 4-6 hours before procedure, obtain vascular access and unfractionated heparin is given, then duct is accessed via a cut pig-tail or Judkins right \[JR\] catheter, and is crossed by PTCA wire to be carefully placed in the left or right branch pulmonary arteries, choose proper stent diameter and length, place the stent and confirm it's position, NICU admission for the neonate with heparin infusion for 24-48 hrs and acetylsalicylic acid is given then follow up the patient by pulse oximeter and echocardiography


Eligibility criteria: Inclusion Criteria:

Neonates and young infants with duct dependent pulmonary circulation

Exclusion Criteria:

* Untreated sepsis.
* Coagulopathy.
* PDA dependent systemic circulation.

Primary outcomes:
measure: Change in Oxygen saturation
timeFrame: Change in oxygen saturation within 24 hours
measure: Evaluation of duct patency
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Sohag University
name: Somaia S Mahmoud, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02470793: Technique And Results In Endothelial Keratoplasty
Official title: Technique And Results Evaluation In Endothelial Keratoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Endothelial Cell Loss
Fuchs' Endothelial Dystrophy
Keywords: Corneal Endothelial Cell Loss
Fuchs' Endothelial Dystrophy
Lamellar Keratoplasty
Descemet Stripping Endothelial Keratoplasty
Descemet Membrane Endothelial Keratoplasty
Minimal Surgical Procedure
Lead sponsor: Hospital Mutua de Terrassa
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess and compare the complications and results of different lamellar endothelial keratoplasty techniques and its variations.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis with corneal endothelial dysfunction requiring lamellar endothelial corneal transplantation.
2. Free acceptance to be enrolled in the trial, and signature of the informed consent by the subject and/or its legal representatives.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Visual acuity
timeFrame: First six months postoperatively
Secondary outcomes:
measure: Endothelial cell density
timeFrame: First six months postoperatively
measure: Intraoperative complications
timeFrame: First six months postoperatively
measure: Postoperative complications
timeFrame: First six months postoperatively
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua Terrassa
state: Barcelona
Study officials:
affiliation: Hospital Universitari Mútua Terrassa
name: Eduard Pedemonte-Sarrias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05315193: Effect of Exercise Training in Coronary Artery Disease Patients After Stenting
Official title: Effects of Exercise Training on Ankle-brachial Index and Quality of Life in Coronary Artery Disease Patients After Stenting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stent Restenosis
Coronary Artery Disease
Keywords: Ankle-Brachial Index
Coronary artery diseases
Exercise training
Quality of life
Stenting
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effects of exercise training on ankle-brachial index and Quality of Life in coronary artery disease patients after stenting. There is a need to develop strategies, not only to prevent restenosis but also to improve patients' functional status and perception of well-being. In particular, it is not well defined whether exercise training can reduce the restenosis rate and improve the outcome after percutaneous intervention (PCI), and its effects on the Ankle-brachial index are not yet well known.

Detailed description: The existence of PAD in patients with Coronary artery disease (CAD) remarkably increases the risk of cardiovascular morbidity and mortality. Almost half of the patients, after an initial encouraging improvement in functional capacity and quality of life (QOL) after the PCI, deal with recurrent chest pain that requires medical attention, reduces functional capacity, and creates a status of psychological distress.

Eligibility criteria: Inclusion Criteria:

* GCS = 15
* Disease chronicity: 1-3 years Elective / stenting procedure
* Single or Double vessel stunting EF: 35 above

Exclusion Criteria:

* Unwilling to participate in research
* Known cases of Uncontrolled DM or HTN
* Known cases of Cognitive/memory/neurological disorders
* Known cases of any Systemic disease

Primary outcomes:
measure: Ankle-brachial index
timeFrame: 12 weeks
measure: Quality of life index cardiac version -IV
timeFrame: 12 weeks
Secondary outcomes:
measure: Dyspnea
timeFrame: 3-5 days
measure: Rate of perceived exertion (RPE)
timeFrame: 12 weeks
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 12 weeks
measure: Forced vital Capacity (FVC)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Peshawar Institute of cardiology
state: KPK
Study officials:
affiliation: Riphah International University
name: Mehwish Waseem, MSPT(CPPT)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03779893: Clinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars
Official title: Clinical Evaluation of Bioactive Resin Based Pits & Fissures Sealants Versus Conventional Resin Based Pits & Fissures Sealants in Caries Susceptible Fissures in Permanent Molars: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Caries, Dental
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will be conducted to evaluate the performance; in terms of retention and caries inhibition; of the newly introduced bioactive resin based pits and fissure sealant versus conventional resin based pits and fissure sealant in caries susceptible fissures in posterior molars in patients at risk of caries. Evaluation will be done by visual tactile examination \& VistaCAM.

Detailed description: In the investigator's study the comparator material will be BioCoat® by Premier® ; new bioactive resin pits and fissures sealant featuring SmartCap™ Technology. SmartCap™ Technology utilizes patented semi-permeable resin microcapsules. In BioCoat, the rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, which diffuse in and out of the sealant. Greater fluoride uptake in the presence of calcium and phosphate ions is assumed.

With limited evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it was found beneficial to evaluate the newly introduced material using a randomized controlled trial to test the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as conventional resin based pits and fissure sealant in susceptible fissures.

Eligibility criteria: Inclusion Criteria of participants:

* Patients with bilateral caries susceptible fissures in molars showing no signs of caries.
* 19 - 40 years.
* Males or Females.
* Co-operative patients approving to participate in the trial.

Exclusion criteria of participants:

* Patients younger than 19 years old or older than 40 years old.
* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Allergic history concerning methacrylate.
* Rampant caries.
* Heavy smoking.
* Xerostomia.
* Lack of compliance.
* Evidence of severe bruxism, clenching, or tempromandibular joint disorders.

Primary outcomes:
measure: Retention of sealant
timeFrame: one year
Secondary outcomes:
measure: Caries incidence
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04687293: Rehabiliation Using HUBER 360 to Reduce the Risk of Falls
Official title: Investigation of the Effectiveness of Rehabilitation Using the HUBER 360 Tool to Reduce the Risk of Falls in People in Pathological Situations Requiring Functional Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Exercise Therapy
Treatment Outcome
Quality of Life
Fall
Keywords: Huber
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: The aim of the present study was to analyse the effects of training performed on a rotating, motorised platform (the Huber/SpineForce device from LPG Systems, Valence, France) intended to reduce the risk of falls.

Subjects: any patient 1) benefiting from a physiotherapy rehabilitation program at the CHU Liège, CNRF, Belgium; 2) presenting a pathological situation justifying functional rehabilitation with HUBER 360®; 3) presenting any pathology not constituting an exclusion criterion; 4) giving informed consent to research will be include in this 8-week interventional trial.

Design: randomized open-label trial. Patients will be randomized into the intervention group (HUBER trainig, 45 minutes of training, twice a week during 8 weeks) or in the control group (standard care).

Outcomes: the effect of the training will be measured on the Time-Up-and-Go test, on the Short-Physical performance battery test and on quality of life.


Eligibility criteria: Inclusion Criteria:

* Patient benefiting from a physiotherapy rehabilitation program at the CHU Liège, CNRF
* Patient presenting a pathological situation justifying functional rehabilitation with HUBER 360®
* Patient presenting any pathology not constituting an exclusion criterion
* Patient giving informed consent to research.

Exclusion Criteria:

* Cardiac or respiratory or neurological or rheumatological disease incompatible with physical activity ;
* Joint inflammation;
* Rheumatic disease in acute phase;
* Recent trauma, infection of the musculoskeletal system;
* Fever;
* Venous thrombosis ;
* Discopathy in acute phase;
* Neuropsychological problems that do not allow to integrate the instructions or other serious psychological problems;
* Cardiovascular diseases and any progressive, chronic, counter-indicative disease;
* Large anatomical deformities.

Primary outcomes:
measure: Risk of falls, in seconds
timeFrame: 8 weeks
Secondary outcomes:
measure: Physical performance
timeFrame: 8 weeks
measure: Quality of life, measured with the Short Form-36 questionnaire
timeFrame: 8 weeks
measure: Utility score using the EuroQol- 5 Dimension questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tinlot
country: Belgium
facility: CHU Liège, CNRF
state: Liège
Study officials:
affiliation: Centre Hospitalier Universitaire de Liege
name: Jean-François Kaux, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01278693: Effect of Oral L-carnitine Supplement on Lipid Profile, Anemia, and Quality of Life of Patients
Official title: Study of Treatment of Dyslipidemia for Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Complication of Hemodialysis
Keywords: Renal failure, hemodialysis, dyslipidemia, L-carnitine.
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 54
Sex: FEMALE
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 Effect of oral L-carnitine supplement on lipid profile, anemia, and quality of life.

Detailed description: In patients under maintenance hemodialysis several factors reduce the body stored carnitine which in turn affected dyslipidemia, anemia, and general health in these patients. The investigators evaluated the effect of oral L-carnitine supplementation on lipid profiles, anemia, and quality of life in hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

being in the age range of 18-75 having the history of at least 12 weeks of hemodialysis and at least three times a week and each session almost for four hours having serum triglyceride or total cholesterol concentration \>200 mg/dl or serum HDL concentration \>40 mg/dl in the beginning of the study.

Exclusion Criteria:

taking carnitine supplement or the drug that interact with carnation lowering the seizure threshold in the last month being affected by liver function abnormalities, hypothyroidism, chronic infectious diseases (such as hepatitis), inflammatory diseases, CNS mass having the history of seizure.

Primary outcomes:
measure: lipid profile
timeFrame: at sixteen weeks after admission
Secondary outcomes:
measure: anemia
timeFrame: at sixteen weeks after admission
measure: quality of life
timeFrame: at sixteen weeks after admission
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Noor university hospital
Study officials:
affiliation: MD,research comittee
name: Mahnaz Moradi, MD
role: STUDY_CHAIR
References: