louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05588037: Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery
Official title: Clinical Assessment of Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Disease
Rhegmatogenous Retinal Detachment
Epiretinal Membrane
Cataract
Vitreous Hemorrhage
Vitreomacular Traction
Vitreous Cloudy
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Based on the progress of cataract surgery, intraocular lens development, vitreoretinal surgery and anesthesia technology in recent years, the purpose of this study is to develop a new type of more accurate and minimally invasive combined surgery for cataract and fundus diseases, and to evaluate the advantages and value of the surgery as well as related complications, so as to minimize the surgical trauma and obtain faster visual function recovery and better patient comfort. To provide new solutions for the growing demand of eye health care.

Detailed description: To evaluate the efficacy and complications of a new type of minimally invasive femtosecond laser assisted-cataract surgery (FLACS) combined with pars plana vitrectomy (PPV) with two-step anesthesia in the treatment of various common fundus diseases such as rhegmatogenous retinal detachment (RRD), epiretinal membrane (ERM), macular hole (MH), and vitreous opacity, complicated with cataract. It is mainly aimed at the following kinds of common fundus diseases with cataract performing PPV and cataract removal combined with monofocal or premium intraocular lens (IOL) implantation： RRD complicated with cataract: FLACS +PPV + IOL+air; ERM complicated with cataract: FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex; MH complicated with cataract: FLACS + PPV+ IOL + internal limiting membrane peeling + air; Vitreous opacity with cataract: FLACS + PPV+ IOL.

Eligibility criteria: Inclusion Criteria: clinical diagnosis of following disease

* RRD with cataract
* ERM with cataract
* MH with cataract
* Vitreous opacity with cataract

Exclusion Criteria: patients with history of following condition

* intraocular surgery
* ocular trauma
* endophthalmitis
* uveitis
* glaucoma

Primary outcomes:
measure: visual acuity
timeFrame: Change from baseline best-corrected visual acuity at 6 months.
Secondary outcomes:
measure: complications
timeFrame: through study completion, an average of 6 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Jiasong Yang
Study officials:
affiliation: Aier Ophthalmology School of Central South University; Shanghai Aier Eye Hospital
name: Wensheng Li
role: STUDY_CHAIR
References:
Clinical trial NCT01925937: Atorvastatin/CoenzymeQ10 in Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Coenzyme Q10
Atorvastatin
clinical trial
congestive heart failure
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effect of addition of combination of Atorvastatin/CoenzymeQ10 to standard congestive heart failure (CHF) treatment versus addition of Atorvastatin alone on CHF outcomes.


Eligibility criteria: Inclusion Criteria:

* Documented Congestive hear failure
* Ejection Fraction less than 40 percent
* Compensated heart failure without hospital admission during previous three months
* No change in type and dose of medications in the last months
* New York Heart Association Function Class 2 to 4

Exclusion Criteria:

* Acute coronary syndrome developing in the last month
* Active myocarditis
* Active pericarditis
* Uncontrolled hypertension
* Hepatic failure(Child B,C)
* Pulmonary failure
* Renal failure
* Heart failure with KILLIP classification 3 and 4

Primary outcomes:
measure: Change in cardiac Ejection Fraction (EF)
timeFrame: Baseline for the first time and after 4 months for the second time
Secondary outcomes:
measure: Change in New York Heart Association Function Class
timeFrame: Baseline for the first time and after 4 months for the second time
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran
Study officials:
affiliation: Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
name: Masoud Pourmoghaddas, cardiologist
role: STUDY_DIRECTOR
References:
Clinical trial NCT06126237: A Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma
Official title: A Phase I/II, Multiple Center, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-label, Phase 1/2 study to evaluate the safety, tolerability, Pharmacokinetics, pharmacodynamics and Preliminary Efficacy of CM313 in Subjects with Relapsed or Refractory Multiple Myeloma.


Eligibility criteria: Inclusion Criteria:

* Subjects age ≥ 18 years.
* Subjects diagnosed with multiple myeloma.
* Subjects with measurable lesions.
* Women of childbearing potential with negative pregnancy testing.
* Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.

Exclusion Criteria:

* Previous treatment with any anti-CD38 therapy.
* Vaccinated with live, attenuated vaccine within 4 weeks prior to the first dose.
* Positive for human immunodeficiency virus (HIV) antibodies.
* Syphilis antibody positive.

Primary outcomes:
measure: Adverse event
timeFrame: up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06837337: The Effect of Turkish Music on Pain and Anxiety During Childbirth
Official title: The Effect of Turkish Music
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childbirth
Pain
Anxiety
Keywords: Nursing Caries
childbirth pain
music
anxiety
Lead sponsor: Sinop University
Sponsor class: OTHER
Collaborators: name: Karamanoğlu Mehmetbey University
First posted: 2025-02-20
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Nurses and midwives stand at the forefront during childbirth; their expertise in using natural pain relief techniques not only lessens the sensation of labor pain but also helps in calming the nerves of expectant mothers. These techniques are not only safe and easy to use but also kind on the pocket and devoid of any adverse effects. Such methods can make childbirth experiences as positive and comfortable as possible. Research has delved deeper into how music shaped by cultural tastes can significantly affect individuals, leading to a closer examination of how Turkish tunes influence discomfort and nervousness during labor. The goal of this research was to explore how Turkish melodies impact pain and anxiety feelings among women going through childbirth for the first time.


Eligibility criteria: Inclusion Criteria:

* primigravida women with term pregnancies (38-40 weeks) in the early active phase of labor
* cervical dilatation between 4 and 6 cm

Exclusion Criteria:

* Women who used narcotic analgesics or sedatives during labor
* listened to music during childbirth
* underwent induction
* delivered via cesarean section

Primary outcomes:
measure: Angle Labor Pain Questionnaire
timeFrame: Approximately one hour after admission to the delivery room, change from the initial pain level in 30 minutes. Scores of Angle Labor Pain Questionnaire ranged from 0 to 220, with higher values indicating greater pain intensity.
measure: Visual Analog Scale (VAS)
timeFrame: Approximately one hour after admission to the delivery room, change from the initial pain level in 30 minutes. VAS is a 10 cm line used to measure perceived pain intensity, with endpoints labeled "No Pain" and "Worst Pain Imaginable."
measure: The State Anxiety Scale (SAS)
timeFrame: Approximately one hour after admission to the delivery room, change from the initial anxiety level in 30 minutes. The total scores range from 20 to 80, with higher scores indicating greater anxiety.
Secondary outcomes:
Other outcomes:
Locations:
city: Sinop
country: Turkey
facility: Sinop University
Study officials:
References:
citation: Guo H, Que M, Shen J, Nie Q, Chen Y, Huang Q, Jin A. Effect of Music Therapy Combined with Free Position Delivery on Labor Pain and Birth Outcomes. Appl Bionics Biomech. 2022 May 11;2022:8963656. doi: 10.1155/2022/8963656. eCollection 2022.
Clinical trial NCT00221559: Serum Zn Status of Patients With Cystic Fibrosis at Diagnosis and One Year Later, Compared to a Healthy Control Group
Official title: Serum Zn Status of Patients With Cystic Fibrosis at Diagnosis and One Year Later, Compared to a Healthy Control Group
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Scientific research fund Bruges
First posted: 2005-09-22
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Serum Zn status of patients with cystic fibrosis at diagnosis and one year later, compared to a healthy control group

Detailed description: Serum Zn status of patients with cystic fibrosis at diagnosis and one year later, compared to a healthy control group

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cystic fibrosis

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Stephanie Van Biervliet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Biervliet S, Van Biervliet JP, Robberecht E. Serum zinc in patients with cystic fibrosis at diagnosis and after one year of therapy. Biol Trace Elem Res. 2006 Sep;112(3):205-11. doi: 10.1385/BTER:112:3:205.
Clinical trial NCT00741559: Combined Role of Position Emission Tomography (PET) and Magnetoencephalography (MEG) in Nonlesional Epilepsy
Official title: Combined Role of PET and MEG in Nonlesional Epilepsy in Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: epilepsy
pediatrics
magnetoencephalography
electroencephalography
positron emission tomography
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2008-08-26
Enrollment: 59
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The first aim of this study are to evaluate the lobar concordance of FDG-PET and MEG with intracranial electrographic study in children with intractable partial epilepsy. The second aim is to determine if the combined role of FDG-PET and MEG improve detection of epileptogenic zone as defined by invasive intracranial recordings.

Detailed description: Children with poorly controlled epilepsy are extensively investigated with various tools including MR brain, electroencephalography (EEG), magnetoencephalography (MEG) or position emission tomography (PET) scans. When MR brain does not show an abnormality, the patient is said to have nonlesional epilepsy. In these cases, it is even more crucial to be able to identify the epileptogenic zone, depending on availability of investigative tool.

Recognizing that individual modalities have limitations, the aim of this study is to determine if combining non-invasive investigations with MEG and PET, which respectively evaluate the electrical and metabolic activity of the brain, could improve the children with intractable nonlesional epilepsy with MEG and PET and compared this with invasive intracranial monitoring. The endpoint of the study being agreement on localizations of epileptogenic zone using PET and MEG individually and in combination and comparing this with invasive intracranial monitoring.

Eligibility criteria: Inclusion Criteria:

* Children between the ages 0-18 years with (1) nonlesional intractable focal epilepsy and (2) those with discordant clinical and EEG findings, who are potential surgical candidates

Exclusion Criteria:

* Patients who are pregnant

Primary outcomes:
measure: The concordance rate of FDG-PET and MEG with video EEG
timeFrame: 3 years
Secondary outcomes:
measure: The positive and negative predictive values of each modality and combined modalities in assessing the epileptogenic zone.
timeFrame: 3 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Martin Charron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06319859: Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries
Official title: Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pain, Postoperative
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 50
Sex: ALL
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 will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-65 years old.
* Both genders.
* ASA I and II class.

Exclusion Criteria:

* Patient refusal.
* Known local anesthetic (LA) allergy.
* Skin lesions or infections at the site of needle insertion.
* Contraindications to spinal anesthesia.
* Failure of spinal anesthesia.
* ASA III and VI class.
* Central or peripheral neuropathies.
* Severe respiratory or cardiac diseases.

Primary outcomes:
measure: Time to first analgesic requirement
timeFrame: 48 hours post-operatively
Secondary outcomes:
measure: Nalbuphine consumption
timeFrame: 48 hours post-operatively
measure: Postoperative pain
timeFrame: at 2, 4,8,12,18,24,30,36,42, and 48 hours post-operatively
measure: The incidence of other adverse effects
timeFrame: 14 days post-operatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alaini hospital
Study officials:
References:
Clinical trial NCT01589159: A Phase Ⅱ Study of an All-Oral Combination of Low-dose Etoposide/Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and/or Taxanes
Official title: A Phase Ⅱ Study of an All-Oral Combination of Low-dose Etoposide/Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and/or Taxanes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-center, open-lable, non-comparative, prospective, phase Ⅱ efficacy and safety study. Eligible patients are enrolled in a single group. The investigators propose to determine the efficacy and safety of low-dose metronomic chemotherapy with Etoposide/Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and/or Taxanes.


Eligibility criteria: Inclusion Criteria:

* female patients between 18 and 65 years old
* patients with metastatic breast cancer previousely treated with A/T
* able and willing to give consent to participate in the study

Exclusion Criteria:

* pregnant or lactating females
* other tumor history
* instable complication (e.g., myocardial infarction within 6 months,arrhythmia, unstable diabetes, hypercalcemia) or uncontrolled infection
* concurrent disease or condition that would make the patient inappropriate for study participation
* resist to participate in the study

Primary outcomes:
measure: Clinical benefit rate
timeFrame: 24 weeks after the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Yan Wei, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT06924359: Multimodal Ophthalmic Imaging and Plasma Biomarkers for the Early Detection of Alzheimer's Disease
Official title: Multimodal Ophthalmic Imaging and Plasma Biomarkers for the Early Detection of Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer&#39;s Disease (AD)
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AD, MCI, SCD and CN

Brief summary: With the accelerating global aging population, dementia has become a pressing worldwide issue. This project aims to identify specific plasma biomarkers and ocular indicators for the early detection of Alzheimer's disease (AD).


Eligibility criteria: Inclusion Criteria:

* Male or female participants aged ≥ 50 years;
* Participants diagnosed with Alzheimer's Disease (AD), mild cognitive decline (MCI), subjective cognitive decline (SCD), or cognitively normal (CN);
* Signed informed consent form

Exclusion Criteria:

* Presence of other neurological disorders and systemic diseases that may cause cognitive impairment;
* Inability to cooperate with cognitive assessments;
* Refusal to undergo blood sampling.

Primary outcomes:
measure: Differences in Multimodal Ophthalmic Imaging parameter values among groups
timeFrame: Baseline
Secondary outcomes:
measure: Concentration difference of plasma biomarkers (Aβ42/40, p - tau181, p - tau217, NfL and GFAP） among groups
timeFrame: Baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References:
Clinical trial NCT02955459: VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers
Official title: VNRX-5133-101/102: A Randomized, Double Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of VNRX-5133 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infections
Keywords: Healthy volunteers
Pharmacokinetics
Lead sponsor: Venatorx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-11-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.


Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Males or non-pregnant, non-lactating females
* Body Mass Index (BMI) between 18.5 - 32.0, inclusive.
* Suitable veins for cannulation

Exclusion Criteria:

* Employee of site or the sponsor
* Any disease that poses an unacceptable risk to participants
* Abnormal ECG
* Abnormal labs
* Abnormal vital signs
* Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
* Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1
* Current smokers or history of smoking within 30 days

Primary outcomes:
measure: Number of subjects with adverse events; assessed by patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
timeFrame: Part 1: 8 days. Part 2: 17 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
state: Kansas
Study officials:
References:
citation: Dowell JA, Dickerson D, Henkel T. Safety and Pharmacokinetics in Human Volunteers of Taniborbactam (VNRX-5133), a Novel Intravenous beta-Lactamase Inhibitor. Antimicrob Agents Chemother. 2021 Oct 18;65(11):e0105321. doi: 10.1128/AAC.01053-21. Epub 2021 Aug 9.