louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06648317: Radiolabelled Nectin-4 Targeted LMW Probe PET/CT in Patients With Lung Lesions
Official title: Radiolabelled Nectin-4 Targeted LMW Probe PET/CT in Patients With Lung Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer, Non-Small Cell
Lung Infection
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with lung lesions

Brief summary: To evaluate the ability of \[68Ga\]N188 to detect nectin-4 overexpression in patients with lung lesions.

Detailed description: To evaluate the ability of \[68Ga\]N188 to detect nectin-4 overexpression in patients with different lung lesions, such as inflammation and lung cancer.

Eligibility criteria: Inclusion Criteria:

1. 18-75 years old, male or female;
2. Heart function is normal;
3. Normal heart function;
4. Estimated survival ≥12 weeks;
5. Good follow-up compliance;
6. presence of at least one measurable target lesion according to RECIST1.1 criteria;
7. Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test;
8. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;
9. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.

Exclusion Criteria:

1. Serious abnormality of liver, kidney and blood;
2. Pregnant patients;
3. Pregnant and lactation women;

3) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.

Primary outcomes:
measure: Standardized uptake value（SUV）
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
Study officials:
affiliation: Peking University Cnacer Hospital & Institute
name: Nan Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04019717: Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection
Official title: A Phase 2 Study Assessing the Safety and Efficacy of AT-527 in Combination With Daclatasvir in Subjects With Chronic HCV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Hepatitis C, Chronic
Chronic Hepatitis C
Hepatitis C Virus Infection
HCV Infection
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will receive 8 or 12 weeks of treatment, based on treatment response.
Primary purpose: TREATMENT

Brief summary: The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after 8 or 12 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) of 18-35 kg/m2
* Must agree to use protocol-specified methods of contraception
* Negative pregnancy test
* HCV genotype 1
* Documented history compatible with chronic hepatitis C
* HCV RNA ≥ 10,000 IU/mL at Screening.
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus or HIV
* Abuse of alcohol or drugs
* Prior exposure to any HCV NS5A inhibitor
* Cirrhosis
* Use of other investigational drugs within 30 days of dosing
* Other clinically significant medical conditions or contraindications to daclatasvir

Primary outcomes:
measure: Proportion of subjects achieving sustained virologic response (SVR)
timeFrame: 12 weeks after end of treatment
measure: Incidence of treatment-emergent adverse events
timeFrame: Through 4 weeks after end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Clinical Trial Site
city: Phoenix
country: Mauritius
facility: Clinical Trial Site
city: Chisinau
country: Moldova, Republic of
facility: Clinical Trial Site
Study officials:
affiliation: Atea Pharmaceuticals, Inc.
name: Xiao-Jian Zhou, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03806517: Bone Mineral Density Changes Among Clinical Subtypes of Parkinson's Disease
Official title: Bone Mineral Density in Tremor Dominant Type Compared to Postural Instability Gait Difficulty Type Parkinson's Disease: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Bone Loss
Keywords: bone mineral density
Parkinson's disease
tremor
postural instability and gait difficulty
akinetic-rigid
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The PD group will be selcted from Neurology Department, Movement Disorders Clinic.

The control group will be selected from community population.

Brief summary: The bone loss in Parkinson's disease (PD) emerges as a non-motor symptom with motor and non-motor outcomes, such as fracture and musculoskeletal pain. Bone mineral density (BMD) is decreasing in patients with PD when compared to sex and age-matched healthy controls. The changes in BMD according to clinical subtypes of PD is unknown. The investigators are planning to compare the BMD status between the tremor dominant and postural instability and gait difficulty type of PD.

Detailed description: The investigators are planning to complete this study between January and February 2019. This study will be performed at Ordu University Education and Research Hospital, Neurology Department.

All patients admitted to the outpatient clinic will be evaluated in terms of inclusion criteria. The control group consisted of people who do not have any orthopedic, neurological or metabolic disorders which may affect the BMD.

Eligibility criteria: For TDT and PIGDT PD group

Inclusion Criteria:

Clinical diagnosis of idiopathic Parkinson's disease Age of 40-85 years

Exclusion Criteria:

Having additional orthopedic and neurological disorders Having metabolic disease, Having steroid drug use

For Control group

The similar age and sex-matched healthy individuals who have no orthopedic, metabolic and neurological disorders, and steroid use will be included in the study.

Primary outcomes:
measure: Dual-energy X-ray absorptiometry (DEXA)
timeFrame: 10-15 minutes
Secondary outcomes:
measure: Hoehn and Yahr Scale
timeFrame: 2 minutes
measure: Unified Parkinson's Disease Rating Scale (UPDRS) - Section of Activities of Daily Living (ADL)
timeFrame: 10 minutes
measure: Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Section
timeFrame: 10 minutes
measure: Unified Parkinson's Disease Rating Scale (UPDRS) - non-motor Section
timeFrame: 5 minutes
measure: Unified Parkinson's Disease Rating Scale (UPDRS) - complications Section
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Sevim ACARÖZ CANDAN
state: Altinordu
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Sevim ACARÖZ CANDAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06500741: Experiment to Assess Preferences for Novel Hormonal Therapy and Androgen-deprivation Therapy in Prostate Cancer Patients
Official title: Discrete Choice Experiment to Assess the Preferences for Novel Hormonal Therapy and Androgen-deprivation Therapy in Patients With Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Novel hormonal therapy
Androgen-deprivation therapy
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2024-07-15
Enrollment: 374
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult prostate cancer patients and urologists or oncologists who have cared for at least ten non-metastatic hormone-sensitive prostate cancer (nmHSPC) patients in the past year.

Brief summary: The purpose of this study is to quantify the preferences for novel hormonal therapy (NHT) +/- androgen-deprivation therapy (ADT) vs ADT monotherapy among patients with non-metastatic hormone-sensitive prostate cancer (PC) in the United States (US), Germany, Spain, France, Italy, the United Kingdom (UK), South Korea, Australia, and Brazil, using a discrete choice experiment (DCE).

Detailed description: The study will collect data from eligible patients (six total) and physicians (six total) from one-on-one qualitative interviews and eligible patients from online surveys. Approximately 330 patients with PC will be recruited to complete the online DCE survey.

Eligibility criteria: Inclusion Criteria:

Physician inclusion criteria

* The physician is a certified urologist or oncologist. The final selection will be adjusted to local practice.
* The physician has cared for at least ten nmHSPC patients in the past year.
* The physician has experience prescribing NHT and ADT. Patient inclusion criteria
* The patient has nmHSPC after radiotheraphy (RT) and/or radical prostatectomy (RP), defined as an adult patient with nmPC who had RT and/or RP.

Exclusion Criteria:

Physician exclusion criteria

* None Patient exclusion criteria
* The patient is castration resistant.
* The patient has metastatic PC.

Primary outcomes:
measure: Patients' Preference weights for different treatment attributes
timeFrame: Up to 1 day
measure: Patients' Overall Preference for a specific treatment profile (NHT +/- ADT or ADT monotherapy)
timeFrame: Up to 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Analysis Group, Inc.
state: Massachusetts
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01872741: Minipterional Versus Pterional Craniotomy
Official title: Prospective Randomized Study Comparing Clinical, Functional and Aesthetics Results of "Classical" Pterional and Minipterional Craniotomies.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Aneurysm
Muscular Atrophy
Keywords: craniotomy,
intracerebral aneurysms,
atrophy,
temporal muscle,
outcome
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized prospective study was designed to compare the clinical, functional and aesthetic results of two surgical techniques for microsurgical clipping of anterior circulation aneurysms

Detailed description: This randomized prospective study was designed to compare the clinical, functional and aesthetic results of two surgical techniques for microsurgical clipping of anterior circulation aneurysms. Overall, 60 eligible patients admitted with ruptured and unruptured anterior circulation aneurysms will enrolled in the study.

The aesthetic results will be analyzed with 2 methods. In the first, the patients will be showed to a rule, with a scale from 0 to 100, in which 0 mean the best result and 100 the worst result. Photos will be taken and showed to two independent observers, the results will be classified as excellent, good, regular or poor. The degree of atrophy will be measured with three methods. In the first one, the authors wiil observes the percentage of thick reduction in the temporal muscle, subcutaneous tissue and skin. In the second method the percentage thick reduction of the isolated temporal muscle will be measured and the third the volumetric analysis of the temporal muscle, subcutaneous tissue and skin will be calculated from the superior edge of zygomatic arch to superior temporal line. The functional results wiil be compared using the Modified Rankin Score. Others variables such frontal facial palsy, post-operative hemorrhage, cerebrospinal fistulas, hydrocephalus and mortality will be also analyzed

Eligibility criteria: Inclusion Criteria:

Diagnosis of intracranial aneurysms

Exclusion Criteria:

Giant aneurysms Intracranial hematomas

Primary outcomes:
measure: Atrophy degree measurement (temporal muscle)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Leonardo C Welling, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Welling LC, Figueiredo EG, Wen HT, Gomes MQ, Bor-Seng-Shu E, Casarolli C, Guirado VM, Teixeira MJ. Prospective randomized study comparing clinical, functional, and aesthetic results of minipterional and classic pterional craniotomies. J Neurosurg. 2015 May;122(5):1012-9. doi: 10.3171/2014.11.JNS146. Epub 2014 Dec 19.
Clinical trial NCT00956241: J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer
Official title: J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer: a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: rectal cancer
colonic pouch
side-to-end anastomosis
preoperative radiotherapy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Dutch Digestive Diseases Foundation
name: Commission of Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek: CKTO).
First posted: 2009-08-11
Enrollment: 127
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to compare the functional and surgical results of the J-pouch with those of the side-to-end anastomosis and their impact on quality of life.

Detailed description: Invalidating anorectal dysfunctions are common after restorative rectal surgery. Improvement of functional results by the technically more demanding J-pouch has been demonstrated in comparison with the straight coloanal anastomosis. In the present multicenter randomized trial we assessed whether the J-pouch is also superior to the side-to-end coloanal anastomosis.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria comprised a histologically proven rectal cancer located in the middle or distal part of the rectum (≤ 10cm from the anal verge), and a WHO performance status ≤ 2.

Exclusion Criteria:

* Patients with a T1 or T4 tumor were excluded
* Patients diagnosed with distant metastases
* A medical history of colonic resection
* Anorectal surgery or chemo- radiotherapy
* Pre-existing fecal incontinence grade III or IV according to Parks10
* Life expectancy of less than one year.

Primary outcomes:
measure: Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months.
timeFrame: 4 months
Secondary outcomes:
measure: Function of the neo-rectum as assessed by the functional outcome questionnaire
timeFrame: 12 months
measure: Surgical results
timeFrame: 4 and 12 months
measure: Quality of life
timeFrame: 4 and 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
References:
citation: Doeksen A, Bakx R, Vincent A, van Tets WF, Sprangers MA, Gerhards MF, Bemelman WA, van Lanschot JJ. J-pouch vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision for rectal cancer: a multicentre randomized trial. Colorectal Dis. 2012 Jun;14(6):705-13. doi: 10.1111/j.1463-1318.2011.02725.x.
Clinical trial NCT01131741: Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate
Official title: Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate as an Indicator for Detecting Intravascular Injection of Epinephrine Containing Test Dose During Operation in Anesthetized Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Injections, Intravenous
Keywords: anesthesia, general
blood pressure
epinephrine
heart rate
injections, intravenous
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
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 whether changes in perfusion index can be used for detecting intravascular injection of an epinephrine in anesthetized adults and to compare its reliability with criteria using changes in heart rate, systolic blood pressure or T-wave amplitude.

Detailed description: Intravenous injection of local anesthetics could result in life-threatening complications during general anesthesia. Physicians usually use local anesthetics containing epinephrine to detect intravascular injection. Existing methods including heart rate, systolic blood pressure and T-wave amplitude are unreliable to detect intravascular injection during anesthesia and a method using changes in perfusion index was recently suggested. This study was designed to determine whether perfusion index is a reliable method to detect intravascular injection of epinephrine containing local anesthetics and to compare its reliability with conventional criteria in sevoflurane anesthetized adults.

We will randomize patients to 2 groups: a saline group and an epinephrine group. Changes in perfusion index, systolic blood pressure, heart rate and T-wave amplitude will be measured during 5 minutes after injection of 3 mL of saline or 1% lidocaine containing epinephrine. we will determine sensitivity, specificity, positive predictive value and negative predictive value.

Eligibility criteria: Inclusion Criteria:

* ASA physical status 1 patients undergoing general anesthesia for elective surgery

Exclusion Criteria:

* emergent operation
* those who are taking anticoagulant medication, calcium channel blockers, or b-blockers
* laparoscopic operation
* history of smoking

Primary outcomes:
measure: change of perfusion index from baseline
timeFrame: during 5 min after injection of epinephrine containing test dose or saline
Secondary outcomes:
measure: change of systolic blood pressure, heart rate, T-wave amplitude from baseline
timeFrame: during 5 min after injection of epinephrine containing test dose or saline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin Huh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03951441: Construct Validity and Reliability SCALE
Official title: Construct Validity and Reliability of the Selective Control Assessment of the Lower Extremity in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Keywords: lower limb
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 52
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with Spastic Cerebral Palsy

Brief summary: The aim of the study was to determine construct validity, discriminant validity and intra- and interrater reliability of the Selective Control Assessment of the Lower Extremity ( SCALE).


Eligibility criteria: Inclusion Criteria:

* diagnosis of spastic cerebral palsy,
* age between 4 and 18 years,
* ability to follow simple instructions.
* ability to walk (GMFCS levels I-IV),

Exclusion Criteria:

* unstable situation regarding their tonus-regulating medications
* orthopedic intervention or surgical correction within the last year,
* botulinum toxin injection within the last 6 months

Primary outcomes:
measure: Selective Control Assessment of the Lower Extremity
timeFrame: 15 minutes
Secondary outcomes:
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: 2 minutes
measure: Gross Motor Function Measurement (GMFM)
timeFrame: 15 minutes
measure: Modified Ashworth Scale (MAS)
timeFrame: 5 minutes
measure: The Physicians' Rating Scale (PRS)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
References:
Clinical trial NCT02878941: Synovial Fluid Analysis of Intraarticular Elbow Fracture
Official title: Synovial Fluid Analysis of Intraarticular Elbow Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elbow Fracture
Joint Contracture
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to obtain and compare bilateral elbow joint synovial fluid from patients with unilateral intraarticular elbow fracture and a contralateral healthy appearing elbow joint. The synovial fluid samples will undergo several forms of analysis for metabolites and proteins. Matched-pair statistical analysis will be performed to determine the metabolites and proteins that may play the greatest role in development of joint contracture.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Intraarticular elbow fracture (humerus, radial head and/or ulna fracture)

Exclusion Criteria:

* Age \<18 years
* Open elbow fracture
* Bilateral elbow fractures
* Patients with history of osteomyelitis of elbow
* Inflammatory arthropathy (ie. Rheumatoid arthritis)
* Prior surgery on fractured elbow

Primary outcomes:
measure: metabolite composition of synovial fluid
timeFrame: time of fracture until surgical fixation (up to 5 weeks after injury)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References: