louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03909633: Effects of Intravenous Anesthesia on Postoperative Cognitive Function in Patients Accepted Painless Gastroenteroscopy
Official title: Effects of Intravenous Anesthesia on Postoperative Cognitive Function in Patients Accepted Painless Gastroenteroscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Cognitive Function
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients will undergoing endoscopy check for all kinds of reasons

Brief summary: The investigators want to study the effect of intravenous anesthesia on postoperative cognitive function in patients accepted gastroenteroscopy ,no additional medication or operation is involved

Detailed description: The investigators want to study the effect of intravenous anesthesia on postoperative cognitive function in patients accepted gastroenteroscopy ,no additional medication or operation is involved.The investigators assess cognitive function through a series of tests for 4 times( within 3 days before the endoscopy ,2 hours after the endoscopy finished,1 week after the endoscopy,3 months after the endoscopy),including WCST、DSST、DST、HADS、MoCA,through self - contrast,the investigators will conclude whether intravenous anesthesia has bad impact on cognitive function or not .

Eligibility criteria: Inclusion Criteria:

* voluntary to participate in
* Vital signs are stable
* no drug or alcohol abuse
* no mental illness
* no severe central system diseases such as brain infarction
* between 18 and 80
* no liver or kidney dysfunction
* will perform endoscopy for various reasons

Exclusion Criteria:

* illiteracy
* color blindness
* can't write or refused to sign informed consent
* unable to follow up regularly or cooperate with the examination
* drug or alcohol abuse
* hearing or visual serious impairment
* has severe central nervous system diseases such as shoke ,neurosyphilis
* uncontrolled high blood pressure or hyperglycemia
* neurosyphilis
* history of craniotomy for various reasons
* liver and kidney dysfunction
* non-digestive tumors
* history of intravenous or general anesthesia for other causes in the last 3 months

Primary outcomes:
measure: Change in patient's cognitive dysfunction evaluated by WCST
timeFrame: 4 months
measure: Change in patient's cognitive dysfunction evaluated by DST
timeFrame: 4 months
measure: Change in patient's cognitive dysfunction evaluated by DSST
timeFrame: 4 months
measure: Change in patient's cognitive dysfunction evaluated by MoCA
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Cai Jian Ting
state: Zhejiang
Study officials:
affiliation: Second affiliated hospital of school of medicine, zhejiang university
name: Cai J Ting
role: STUDY_CHAIR
References:
Clinical trial NCT04080687: Effect of Ankle-foot Orthoses on Balance Confidence
Official title: Effect of Ankle-foot Orthoses on Patients' Confidence in Balance-related Activities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Nerve Disease
Peripheral Nerve Injury Lower Limb
Poliomyelitis
Cerebral Palsy
Multiple Sclerosis
Keywords: ankle-foot orthoses
lower limbs
rehabilitation outpatients
balance confidence
falls
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients of our Prosthetics and Orthotics Outpatient Clinic who have had an ankle-foot orthosis for at least 1 year and able to fill in the ABC Scale

Brief summary: The patients at our Prosthetics and Orthotics Outpatient Clinic who have had an ankle-foot orthosis for at least one year will fill in the Activities-Specific Balance Confidence Scale (ABC Scale) for wearing the orthosis and for not wearing the orthosis. They will also answer a mini survey about falls in order to determine whether they have fallen within the last 6 months.

Detailed description: The effect of the orthosis will be estimated as the difference between the two ABC Scale scores. The ABC Scale score and individual items will be compared between the fallers and the non-fallers.

Eligibility criteria: Inclusion Criteria:

* patients at our Prosthetics and Orthotics Outpatient Clinic having an ankle-foot orthosis for at least 1 year

Exclusion Criteria:

* insufficient cognitive ability to fill in the ABC Scale

Primary outcomes:
measure: ABC Scale
timeFrame: At day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Republic of Slovenia
name: Helena Burger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01228487: Influence of Oxidative Dysbalance on Secondary Osteoarthritis
Official title: Biomechanical Factors of Secondary Osteoarthritis: Oxidative and Nitrosative Stress as Predictive Factors of Joint Destruction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Keywords: Oxidative Dysbalance
Oxidative Stress
Biomarker
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2010-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University clinic, patients, residents of Düsseldorf, Germany and surrounding cities

Brief summary: The important role of mechanical joint stress for the insert and progress of osteoarthritis (OA) is supported by recent studies. The degeneration of joint cartilage is caused either by unphysiological load of a healthy joint or physiological load of a damaged joint. The exact mechanisms leading from increased weight bearing and overuse to cartilage degeneration are mostly unknown.

The hypothesis of the study is that parameters of oxidative stress in the joint synovial space reflect damages possibly leading to OA. These parameters correlate with parameters of oxidative stress in the peripheral blood. Aim of the study is the identification of such non- invasive obtainable biomarkers which represent the degenerative and regenerative changes in joint.

Detailed description: Patients with clinically manifest OA typically consult the physician at time of irreversible cartilage destruction. This is due to the long time clinically silent progress of the disease. A biomarker screening profile for joint damage is a valuable tool for the detection of over use and joint damaging conditions especially in competitive sports. This would provide a method for OA risk assessment for the patient before clinical symptoms occur. For this the first step is the identification of biological substances reflecting pathologic changes in the joint.

Since preterm chondrocyte senescence, apoptosis and ageing related changes are key factors in OA pathophysiology and each of these factors is closely related to oxidative dysbalance the measurement of these factors and correlation with the amount of joint damage is promising.

Eligibility criteria: Inclusion Criteria:

* Planned knee joint arthroscopy
* No history of trauma

Exclusion Criteria:

* Neoplasia
* Rheumatoid arthritis
* Intake of Steroids, cytostatic drugs,immunosuppression
* Pregnancy or lactation
* Addiction
* Participation in other clinical trials

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Orthopedic Department, Heinrich-Heine University Medical School
state: NRW
Study officials:
References:
Clinical trial NCT05887687: 68Ga-P3 PET/CT Imaging in Malignancy
Official title: A Study to Evaluate 68Ga-P3 PET/CT Imaging of PSMA Expression in Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Keywords: [68Ga]P3
PSMA
PET/CT
Neoplasms
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.

\[68Ga\]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.

Detailed description: Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that consists of 750 amino acids. It is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making PSMA a highly specific and significant imaging target for malignancies.\[68Ga\]P3, a novel molecular probe of PET imaging agent that targets PSMA, can be used in the diagnosis and research of a wide variety of PSMA high-expression malignanciesr.

Eligibility criteria: Inclusion Criteria:

patients with confirmed or suspected cancer; 18F-FDG PET/CT within 1 week; Signed written informed consent

Exclusion Criteria:

Pregnant and lactating women; Female patients plan to become pregnant within 6 months.

Primary outcomes:
measure: The diagnostic efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors
timeFrame: 1 year
measure: The detection efficacy of 68Ga-P3 PET/CT in the evaluation of malignant tumors
timeFrame: 1 year
Secondary outcomes:
measure: The dosimetry of 68Ga-P3
timeFrame: 1 year
measure: Quantitative evaluation of 68Ga-P3
timeFrame: 1 year
measure: Correlation with pathological expression
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03993587: The Effect of Head and Shoulder Positioning on the Cross-sectional Area of the Subclavian Vein in Obese Adults
Official title: The Effect of Head and Shoulder Positioning on the Cross-sectional Area and Location of the Subclavian Vein in Obese Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Volunteers
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy obese adults (BMI ≥ 30)

Brief summary: In the present study, the cross-sectional area of subclavian vein, and the depth of the SCV from the skin are assessed in different head positions (neutral, rotation to ipsilateral or contralateral sides) and different shoulder positions (neutral or lowered) in spontaneous breathing obese adults.


Eligibility criteria: Inclusion Criteria:

* Healthy obese adults (BMI ≥ 30)

Exclusion Criteria:

* Medication affecting vascular elasticity History of central venous catheterization or clavicle fracture History of lung surgery, operation of chest cage

Primary outcomes:
measure: Cross-sectional area of subclavian vein
timeFrame: through the completion of assessment, an average of 1 hr
Secondary outcomes:
measure: Depth of subclavian vein from skin
timeFrame: through the completion of assessment, an average of 1 hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jin-Young Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05599087: Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration
Official title: Encapsulated Acellular System From Mesenchymal Stem Cells for Endodontic Treatment of Patients With Apical Periodontitis: Phase I Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Periapical Periodontitis
Keywords: mesenchymal stem cells
regenerative procedures
dental pulp
pulp regeneration
allogenic acellular system
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
Collaborators: name: Cells for Cells
First posted: 2022-10-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the security and efficacy in the administration of encapsulated acellular system derived from Mesenchymal Stem Cells as a novel regenerative endodontic procedure which to promote the pulpar regenration.


Eligibility criteria: Inclusion Criteria:

* Systemically healthy patients (ASA I).
* Patient presenting with a maxillary or mandibular incisor/canine and mandibular premolar with mature apex, pulpal necrosis, and apical radiographic evidence of apical periodontitis (PAI ≥2 and CBCTPAI ≥1).
* Patient presents with a tooth that does not respond to electrical and thermal pulp testing.
* Patients with restorable teeth (considering the definition of class A or B, according to Samet and Jotkowitz classification) without the need for a single fine prosthesis (crown) or major restoration.

Exclusion Criteria:

* Patients not available for the follow-up period (27 weeks).
* Patients who will undergo orthodontic treatment in the next six months.
* Patients with reports of allergies to any material or medication used in the study.
* Pregnant patients.
* Heavy smokers (more than 10 cigarettes per day).
* Patients with a history of systemic diseases that impair immune function, such as diabetes mellitus, immunodeficiency, leukemia, Addison's and Cushing's disease.
* Patients who have used immunosuppressive drugs or chemotherapy, 3 months before the study. Or that they will be irradiated or undergo chemotherapy.
* Patients who have endodontically treated teeth.
* Patients who have teeth with signs of severe root resorption.
* Patients who have teeth with mobility class III or Dens invaginatus.
* Patients who have teeth with a history of avulsion-type dentoalveolar trauma.
* Patients who have teeth with clinical and/or radiographic evidence of root fracture.
* Patients who have teeth that cannot be completely isolated with rubber dam.
* Patients who have teeth with more than one root or root canal.

Primary outcomes:
measure: Regeneration of dental pulp
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Las Condes
country: Chile
facility: Universidad de los Andes
state: Region Metropolitana
Study officials:
References:
Clinical trial NCT02720887: Presence of Nanoparticles in the Amniotic Fluid
Official title: Single-center Prospective Descriptive Study Evaluating the Presence of Nanoparticles in the Amniotic Fluid in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrauterine Disorder
Keywords: pregnant women
nanoparticles
amniotic fluid
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: SAINBIOSE
First posted: 2016-03-28
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who receive an amniocentesis for medical reasons other than study

Brief summary: The nanoparticles (NP) are defined as particles whose size is no greater than 100 nanometers. However, their impact on health remains little evaluated.

Placental transfer of NP has been proven in many studies in vitro and in vivo in animals, and toxicity in the fetus has been studied in many animals. The investigators seem interesting at first to establish the mineralogical load in the amniotic fluid in humans.

The first objective of this study is to determine the mineralogical NP load, quantity and composition, in the amniotic fluid in pregnant women.

Detailed description: The analysis will be done on 100 amniotic fluid samples and 100 blood samples. Particle size analysis will be performed by a technique of dynamic light scattering, which permits the distribution by volume or by number of NP according to their size. Parallel to the different chemical species present in the sample must be measured by atomic emission spectrometry with inductively coupled plasma.

The results of this study will be useful for further studies on the fetal toxicity of NP in humans.

Eligibility criteria: Inclusion Criteria:

* Patient major
* Patient to receive an amniocentesis for medical reasons other than study (serum marker of the first quarter with an increased risk of trisomy 21 greater than 1/250, amniodrainage, sonographic sign of call)
* Patient who have given their free, informed and signed

Exclusion Criteria:

* Inability to make withdrawals

Primary outcomes:
measure: Percentage of nanoparticles in amniotic fluid (%)
timeFrame: day 1
Secondary outcomes:
measure: Percentage of nanoparticles in blood
timeFrame: day 1
measure: Correlation Nanoparticles between blood and amniotic fluid
timeFrame: day 1
Other outcomes:
Locations:
city: St Etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Celine CHAULEUR, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raia-Barjat T, Prieux C, Leclerc L, Sarry G, Grimal L, Chauleur C, Pourchez J, Forest V. Elemental fingerprint of human amniotic fluids and relationship with potential sources of maternal exposure. J Trace Elem Med Biol. 2020 Jul;60:126477. doi: 10.1016/j.jtemb.2020.126477. Epub 2020 Feb 27.
Clinical trial NCT04898387: Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
Official title: Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension Glaucoma
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2021-05-24
Enrollment: 554
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: To demonstrate the non-inferiority of T4030 unpreserved eye drops compared to Ganfort® UD in terms of efficacy.

Detailed description: Efficacy Parameters IOP assessment in each eye

Eligibility criteria: Inclusion Criteria:

* Informed consent signed and dated\*
* Patient aged ≥18 years old
* Both eyes with a central corneal thickness assessment ≥500 µm and ≤600 μm a
* Both eyes with diagnosed ocular hypertension or open angle glaucoma

Exclusion Criteria:

* History of narrow angle and/or angle closure glaucoma
* Advanced stage of glaucoma

Primary outcomes:
measure: IOP assessment
timeFrame: Week 12
Secondary outcomes:
measure: Ocular Sign
timeFrame: Week 6 Week 12
Other outcomes:
Locations:
city: Stara Zagora
country: Bulgaria
facility: Medical Center Vereya EOOD
Study officials:
affiliation: Laboratoires Thea
name: CORENTIN LECAMUS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00010387: Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia, Hemolytic, Autoimmune
Felty Syndrome
Purpura, Thrombocytopenic
Autoimmune Diseases
Keywords: Felty syndrome
autoimmune hemolytic anemia
autoimmune neutropenia
hematologic disorders
immune thrombocytopenic purpura
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 2001-02-02
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.

Detailed description: PROTOCOL OUTLINE: Patients receive high-dose cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) starting on day 10 and continuing until blood counts recover.

Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of severe autoimmune hematologic disease Autoimmune hemolytic anemia OR Immune thrombocytopenia
* Failure of at least 2 standard treatment approaches (e.g., prednisone therapy, splenectomy, intravenous immunoglobulin, or other immunosuppressants)
* Inability to taper prednisone dose to less than 10 mg/day OR Autoimmune neutropenia including the following: Felty's syndrome OR Disorders of large granular lymphocytes with recurrent infections or absolute neutrophil count less than 200/mm3

--Prior/Concurrent Therapy--

* See Disease Characteristics

--Patient Characteristics--

* Age: Not specified
* Performance status: Not specified
* Hematopoietic: See Disease Characteristics
* Hepatic: Not specified
* Renal: Creatinine no greater than 2.5 mg/dL
* Cardiovascular: Ejection fraction at least 40%
* Pulmonary: FVC, FEV1, or DLCO at least 50% predicted

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Not preterminal or moribund

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Robert A. Brodsky
role: STUDY_CHAIR
References: