louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06577857: Inferonasal MIMS® Procedure: Long-Term Follow-Up Extension Study
Official title: Minimally Invasive Micro Sclerostomy (MIMS®) Inferonasal Procedure: Long-Term Follow-Up Extension Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Open Angle Glaucoma
Keywords: Intraocular Pressure
MIMS
Inferonasal
Minimally Invasive Glaucoma Surgery
Trabeculectomy
Sclerostomy
MIGS
Lead sponsor: Sanoculis Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 53
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of subjects of Armenian descent that underwent the MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment.

Brief summary: A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).


Eligibility criteria: Inclusion Criteria:

1. Subject who underwent MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment

Primary outcomes:
measure: Intraocular Pressure Change (Baseline to 24 months)
timeFrame: Baseline to 24 months post-MIMS® surgery
measure: Intraocular Pressure Change (Baseline to 30 months)
timeFrame: Baseline to 30 months post-MIMS® surgery
measure: Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 24 Months)
timeFrame: Medicated baseline to 24 months post-MIMS® surgery
measure: Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 30 Months)
timeFrame: Medicated baseline to 30 months post-MIMS® surgery
measure: Surgery Success Rate (24 months)
timeFrame: 24 months post-MIMS® surgery
measure: Surgery Success Rate (30 months)
timeFrame: 30 months post-MIMS® surgery
Secondary outcomes:
measure: Postoperative Complication Safety Outcomes
timeFrame: Baseline to 30 months post-MIMS® surgery
measure: Interventional Safety Outcomes
timeFrame: Baseline to 30 months post-MIMS® surgery
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: S. Malayan Eye Center
Study officials:
References:
Clinical trial NCT03830957: Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
Official title: Randomized Clinical Trial of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
CT Angiography
Ischemic Cardiomyopathy
Non-ischemic Cardiomyopathy
Heart Failure, Systolic
Heart Failure，Congestive
Heart Failure, Diastolic
Heart Rate Low
Lead sponsor: Rajaie Cardiovascular Medical and Research Center
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare the effects of Ivabradine and metoprolol to reduce heart rate prior to coronary CT angiography in patients with advanced heart failure.


Eligibility criteria: Inclusion Criteria:

* Sinus rhythm
* Heart rate \>60/min

Exclusion Criteria:

* Atrial fibrillation
* Any contraindication for beta-blocker use

Primary outcomes:
measure: Heart rate
timeFrame: 30 minutes before and after coronary CT angiography
Secondary outcomes:
measure: Dyspnea
timeFrame: 30 minutes before and after coronary CT angiography and 6 months later
measure: Functional calss
timeFrame: 30 minutes before and after coronary CT angiography and 6 months later
measure: Blood pressure, systolic and diastolic
timeFrame: 30 minutes before and after coronary CT angiography and 6 months later
measure: Sleep quality
timeFrame: Before CT angiography and 6 months later
measure: Appetite
timeFrame: Before CT angiography and 6 months later
measure: Prolonged bradycardia
timeFrame: 30 minutes before and after coronary CT angiography
measure: Hypotension
timeFrame: 30 minutes before and after coronary CT angiography
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ahmad Amin
Study officials:
References:
Clinical trial NCT02263157: Evaluate the Association Between Infection and Thrombocytopenia
Official title: Evaluate the Association Between Blood Stream Infection (BSI) and Thrombocytopenia (Surgical Intensive Care Unit)SICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombocytopenia
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sequential consenting adult patients of either sex were prospectively enrolled into the study.

Brief summary: The study is designed to evaluate the association between nosocomial bloodstream infection and the occurrence of thrombocytopenia in surgical critical ill patients.


Eligibility criteria: Inclusion Criteria:

* Sequential consenting adult patients of either sex were prospectively enrolled into the study.

Exclusion Criteria:

* Patients who passed away within 24 hours after hospitalization would be excluded.

Patients who developed into a bloodstream infection within 48 hours after hospital admission were also excluded.

Primary outcomes:
measure: mortality rate
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04491357: Prophylactic Infusion of Calcium Gluconate Reducing the Rate of Hypocalcaemia After Total Thyroidectomy
Official title: The Use of Prophylactic Infusion of Calcium Gluconate Compared to Placebo in Reducing the Rate of Hypocalcaemia After Total Thyroidectomy: A Double-Blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypocalcemia
Keywords: Hypocalcaemia
Total thyroidectomy
Calcium gluconate
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Post-total thyroidectomy hypocalcaemia is a common complication with the rate ranging from 13-49% in a meta-analysis. However, the rate in UMMC in 2018 and 2019 were 40% and 23% respectively. It lead to prolonged hospital stay and patient dissatisfaction in the event of hypocalcaemia.

Research question: Does prophylactic intravenous calcium infusion reduces the rate of post-total thyroidectomy hypocalcaemia? This study will conduct in UMMC endocrine surgery unit with the target population who scheduled for total thyroidectomy in UMMC between 1/6/2020-1/6/2022.

After obtaining consent from participants, they will be randomised into intervention and placebo group with the ratio of 1:1. Intervention group will receive the intravenous calcium gluconate infusion and placebo group will receive saline infusion within 4 hour of skin closure. Both groups will have their serum calcium measure at 6,12,24,36,48-hour mark post surgery. Both groups will receive same oral calcium supplements.

Detailed description: All participating patients will be randomised into intervention and placebo arm with 1:1 ratio. Intervention group will receive 1 ampoule of intravenous calcium gluconate within 4 hours of post total thyroidectomy, whereas the placebo group will received 100ml of normal saline only. Both groups will receive same oral calcium supplements post surgery. Both groups will have their serum calcium measure at 6,12,24,36,48-hour mark post surgery.

Eligibility criteria: Inclusion Criteria:

* Age between 18-80 years old
* Scheduled for total thyroidectomy in UMMC

Exclusion Criteria:

* Their age outside the range of 18-80
* Have parathyroid disorders or end stage renal failure
* On calcium or vitamin D supplements prior to surgery
* Have deranged calcium homeostasis (outside the normal range of 2.2-2.6 mmol/L)
* Scheduled for total thyroidectomy plus lymph node dissection

Primary outcomes:
measure: Rate of hypocalcaemia after total thyroidectomy
timeFrame: first 48 hours after total thyroidectomy
Secondary outcomes:
measure: Length of hospital stay
timeFrame: first 48 hours after total thyroidectomy
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
Study officials:
affiliation: University of Malaya
name: Kah Seng Khoo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01981057: Clinical Experience With Numeta in Preterm Infants
Official title: Clinical Experience With Numeta- Impact on Intake of Nutrients and Costs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Infants
Keywords: parenteral nutrition
Numeta
prescription software Cato Pan
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: preterm infants

Brief summary: The aim of this prospective noninterventional study is to evaluate the clinical application of Numeta® in preterm infants and critically ill neonates in comparison to individualized prescribed parenteral nutrition. With the prescription software Cato-PAN® (by Cato software solutions) exact valid prescriptions for ordering parenteral nutrition solutions for premature infants are compared. Each PN solution is prescribed individually as well as with Numeta. Prescriptions were mirrored with respect to weight, venous approach, total volume and amount of enteral feeding, 24h medication and flipped vice versa. The key nutrient for calculating Numeta prescriptions was protein. The results of PN prescriptions were compared with each other/ESPGHAN recommendations. The investigators hypothesize that nutrimental content of Numeta prescriptions is equal to individually prescribed .parenteral nutrition solutions


Eligibility criteria: Inclusion Criteria:

* preterm infants \<37 weeks gestational age
* parenteral nutrition therapy

Exclusion Criteria:

* hypersensitivity to egg, soy or peanut proteins or to any of the active substances
* congenital abnormality of the amino acid metabolism
* pathogenically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorous
* severe hyperglycemia
* severe hyperlipidemia
* severe disorders of lipid metabolism characterized by hypertriglyceridemia

Primary outcomes:
measure: Protein
timeFrame: 6 weeks
Secondary outcomes:
measure: Energy
timeFrame: 6 weeks
measure: Carbohydrates
timeFrame: 6 weeks
measure: Fat
timeFrame: 6 weeks
measure: Sodium
timeFrame: 6 weeks
measure: Potassium
timeFrame: 6 weeks
measure: Calcium
timeFrame: 6 weeks
measure: Magnesium
timeFrame: 6 weeks
measure: Phosphorous
timeFrame: 6 weeks
measure: Osmolarity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Nadja Haiden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kreissl A, Repa A, Binder C, Thanhaeuser M, Jilma B, Berger A, Haiden N. Clinical Experience With Numeta in Preterm Infants: Impact on Nutrient Intake and Costs. JPEN J Parenter Enteral Nutr. 2016 May;40(4):536-42. doi: 10.1177/0148607115569733. Epub 2015 Feb 5.
Clinical trial NCT06486857: Accuracy Assessment of a Novel Gas Detection Approach in Dyslipidemia Diagnosis
Official title: Accuracy Validation Study of a Novel Gas Detection Method for Dyslipidemia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dyslipidemias
Gas Detection Method
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteer

Brief summary: This study aims to validate the feasibility and accuracy of a novel gas detection method for dyslipidemia screening by analyzing the lipid profile of human breath metabolites. It explores a simple, rapid, and non-invasive method for screening dyslipidemia. The application prospects of this method are broad; it can be used not only for early screening and monitoring of dyslipidemia in hospitals and communities, providing strong support for the prevention of cardiovascular diseases, but also for the routine monitoring and treatment effectiveness evaluation of patients with hyperlipidemia, offering a scientific basis for personalized treatment plans. This study not only has profound scientific value but also provides a theoretical basis for the development of subsequent new clinical testing methods.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Voluntarily signed the informed consent form

Exclusion Criteria:

1. Patients with lung cancer, asthma, chronic obstructive pulmonary disease, pulmonary cystic fibrosis, or acute respiratory distress syndrome
2. Women who are pregnant or breastfeeding
3. Patients with chronic kidney disease (GFR \< 60 ml/min) or cirrhosis
4. Individuals unable to cooperate with the collection of exhaled gas samples

Primary outcomes:
measure: accuracy of cholesterol testing
timeFrame: within 1 week day of sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03661957: Non Grafted Maxillary Sinus Floor Elevation With Implant Placement Versus the Use of Short Endosseous Implants
Official title: Non Grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Versus the Use of Short Endosseous Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Stability of Implants
Marginal Bone Loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment the need for sinus floor elevation when restoring atrophic posterior maxilla or it will be enough to use of short implant


Eligibility criteria: Inclusion Criteria:

* Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤8 mm length implants.
* Both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Sinus pathology.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
* Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Primary outcomes:
measure: primary stability
timeFrame: 6 months
Secondary outcomes:
measure: marginal bone loss
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Maher Mansour
Study officials:
References:
Clinical trial NCT06983457: Comparative Effects of TherapeuticU and Shockwave Therapy on Pain and QOL in Patients With Chronic Heel Spur Pain
Official title: Comparative Effects of Therapeutics Ultrasound and Shockwave Therapy on Pain and Quality of Life in Patients With Chronic Heel Spur Pain. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heel Spur
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 41
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research aims to compare the effectiveness of therapeutic ultrasound (TUS) and extracorporeal shockwave therapy (ESWT) in managing chronic heel spur pain and improving patients' quality of life. Chronic heel spur pain, often associated with plantar fasciitis, is a debilitating condition that affects mobility and daily activities.

Detailed description: The study will be conducted at Sehat Medical Complex, Lahore, over 10 months, enrolling 60 participants diagnosed with chronic heel spur pain. They will be randomly assigned into two groups: one receiving therapeutic ultrasound (10 sessions over two weeks with a frequency of 1 MHz and intensity between 0.8-2.0 W/cm²) and the other undergoing shockwave therapy (five weekly sessions with 2500 shocks per session at increasing pressure levels from 2.5 to 3.5 bars). The effectiveness of these interventions will be evaluated using the Visual Analog Scale (VAS) for pain intensity, the Foot Function Index (FFI) for functional assessment, and for quality of life. Follow-up assessments will be conducted at baseline, after the intervention (week 4), and at week 8 to evaluate both short-term and sustained treatment effects.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with chronic heel spur pain, confirmed through imaging studies (e.g., X-ray, ultrasound).
* Age range: 30-60 years. Both male and female included
* Chronic heel pain persisting for more than 1 month.
* Individuals with no prior surgical intervention for heel pain.
* Ability to provide informed consent and comply with the treatment protocol.

Exclusion Criteria:

* Presence of systemic inflammatory conditions such as rheumatoid arthritis or gout.
* History of previous steroid injection less than 6 weeks.
* prior NSAID treatment less than 1 week,
* Individuals with contraindications to ultrasound or shockwave therapy, such as pacemakers or implanted devices.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 12 Months
measure: Quality Of Life
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sehat Medical Complex, Hanjarwal campus
state: Punjab
Study officials:
References:
Clinical trial NCT01453257: Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients
Official title: A Phase 2 Study of Target-Guided Personalized Chemotherapy in Metastatic Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Progression Free Survival
Keywords: Molecular Targets
Personalize Treatment
Colon Cancer
Complete Response Rate
Lead sponsor: Grupo Hospital de Madrid
Sponsor class: OTHER
First posted: 2011-10-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment options for patients with colorectal cancer (CRC) have increased in the last years. However, there are no validated prospective molecular markers in CRC to select which agents are better to treat any individual case. The conventional first-line treatment in CRC patients in clinical studies get a proportion of patients free of progression at 12 months ranging from 35-40% with a median of 9 months of free disease progression.

The aim of this study is to demonstrate that the identification of therapeutic targets in real time and their prospectively use to customize the treatment get a proportion of colorectal metastatic patients patients free of progression disease at 12 months of 50%.


Eligibility criteria: Inclusion Criteria:

* Colorectal adenocarcinoma stage IV patients.
* ECOG= 0-1
* Age \> 18 years.
* Fit to receive chemotherapy treatment
* Availability of tumor tissue or possibility of a tumor biopsy to determine therapeutic targets.
* Adequate renal (Cr \< 1,5 mg/d), liver (bilirubin≤1,5 mg/dl, AST and ALT ≤ 3.0 x the upper limit of normal) and normal bone marrow function ( absolute neutrophil count ≥ 1500/µl, hemoglobin ≥ 9.0g/dl and a platelet count of ≥ 100.000/µl)

Exclusion Criteria:

* Contraindication for the administration of any of the drugs used in the study including capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab.
* Previous Chemotherapy treatment

Primary outcomes:
measure: PFS
timeFrame: 12 months
Secondary outcomes:
measure: Complete Response Rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro Integral Oncológico Clara campal
Study officials:
affiliation: Grupo Hospital madrid
name: Antonio Cubillo, Md PhD
role: PRINCIPAL_INVESTIGATOR
References: