louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05930457: Study of 64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors
Official title: Study of 64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Solid Tumors
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Sinotau Pharmaceutical Group
First posted: 2023-07-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is the study of 64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.


Eligibility criteria: Inclusion Criteria:

* 1. signed the informed consent
* 2. ≥18 years old
* 3. confirmed as malignant solid tumor by histopathology or clinical judgment
* 4. Patients will undergo 18F-FDG PET/CT examination

Exclusion Criteria:

* 1. Known allergy to components of the investigational drug or its analogues
* 2. suspected to have a certain disease or condition that is not suitable for the study drug
* 3. Known pregnant or lactating women

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 7 days following injection]
Secondary outcomes:
measure: The diagnostic efficacy of 64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor
timeFrame: 2 months following injection
measure: Change in 'treatment strategy questionnaire'
timeFrame: 2 months following injection
Other outcomes:
measure: Uptake of the 64Cu-FAPI-XT and optimal scanning specifications for future studies
timeFrame: From first dose of imaging study drug through two hours post dose
measure: Determine impact of administered dose of 64Cu-FAPI-XT on image quality
timeFrame: From first dose of imaging study drug through two hours post dose
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
Study officials:
References:
Clinical trial NCT00816257: Lung Transplant Specimen Repository and Data Registry Protocol
Official title: Lung Transplant Specimen Repository and Data Registry Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplantation
Keywords: lung tissue repository
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2009-01-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lung transplant recipients

Brief summary: All patients enrolled in the registry will be recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts). During the routine management of lung recipients frequent surveillance of the lung allograft is necessary. This routinely involves: measurement of pulmonary functions, chest radiography, collection of peripheral blood to assess other organ function and monitor therapeutic drug levels, and bronchoscopic evaluation allowing for collection of lung lavage fluid and lung tissue biopsy. This surveillance normally follows a set schedule during the first one to two years following the transplant procedure. Surveillance is routinely performed at weeks 2, 8, 12, 24, 36, and 52 during the first year following the transplant procedure. Additional surveillance may be performed at any time when clinically indicated for the optimal management of the recipient. Information and specimens collected from each of these encounters will be entered in the data registry and specimen repository.

Detailed description: The collection of disposable lung allograft (transplant tissue samples), blood samples and information from medical records for storage, future analysis and research. Stored samples will be available to other researchers who have obtained separate review and approval from an ethics committee called an Institutional Review Board.

Immediately prior to the transplant surgery, the surgeon or pulmonologist will routinely examine the lungs via bronchoscopy during which subjects will be medicated for pain.

The samples that are obtained during this and post-surgery (clinically scheduled) bronchoscopies, including bronchial lavage, are either sent to pathology or are discarded if they do not qualify to go to pathology. For this research, the researchers are asking that the samples that do not qualify for pathology be placed into the repository instead of being thrown away.

Eligibility criteria: Inclusion Criteria:

* recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts).

Primary outcomes:
measure: data registry and lung tissue repository
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: David Nunley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04696757: Non-OpeRative MANagement of Rectal Cancer Patients
Official title: Non-OpeRative MANagement of Rectal Cancer Patients Who Had Clinical Complete Response After Pre-operative Chemo-raDiotherapY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Chemoradiotherapy
Watch & Wait
Keywords: Rectal Cancer
Chemoradiotherapy
Watch & wait
Capecitabine
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Aim: 1) to analyze the treatment results after receiving capecitabine adjuvant chemotherapy for 4 months after non-surgical treatment in patients who had completed and could have clinical complete remission with capecitabine preoperative chemoradiotherapy with capecitabine for mid-to-lower rectal cancer 2) to investigate the feasibility of non-surgical treatment.
Primary purpose: TREATMENT

Brief summary: This study is a single-center, open, prospective, single-treatment trial (pilot study). This study aims to analyze the treatment results after receiving capecitabine adjuvant chemotherapy for 4 months after non-surgical treatment in patients who had completed and could have clinical complete remission with capecitabine preoperative chemoradiotherapy with capecitabine for mid-to-lower rectal cancer and to investigate the feasibility of non-surgical treatment.

Detailed description: Indication:

1. mid-to-lower rectal cancer was diagnosed histologically as adenocarcinoma in preoperative examination,
2. the tumor was located at the lower boundary of the tumor spans the anorectal junction, and the clinical stage is stage 2 or 3, and
3. clinical complete remission was confirmed after the treatment response evaluation at 8 weeks after completion of preoperative chemoradiotherapy according to MR/SFS and biopsy.

Aim:

1. to analyze the treatment results after receiving capecitabine adjuvant chemotherapy for 4 months after non-surgical treatment in patients who had completed and could have clinical complete remission with capecitabine preoperative chemoradiotherapy with capecitabine for mid-to-lower rectal cancer
2. to investigate the feasibility of non-surgical treatment.

Eligibility criteria: Inclusion Criteria:

* Clinical CR after pre-operative CRT for Rectal cancer

Exclusion Criteria:

-

Primary outcomes:
measure: DFS
timeFrame: Duration from Pre-operative CRT
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
name: Dong-Hoe Koo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04844957: Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope Child and it 's RAAS
Official title: Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope（NMS） Child and it 's RAAS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Vitamin D
Keywords: children ; VVS； vitamin D ; symptom score ; RAAS
Lead sponsor: LanZhou University
Sponsor class: OTHER
Collaborators: name: LanZhou University
First posted: 2021-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: children ; autonomic nervous mediated syncope； vitamin D ; symptom score ; renin-angiotensin-aldosterone-system

Detailed description: children with autonomic nervous mediated syncope have seriously affects children's physical and mental health and quality of life, and the incidence rate is also increasing year by year. But the current treatment measures are not ideal, Therefore, we need to look for new biological indicators, according to different biological indicators to develop different treatment options, so as to improve the current situation of poor treatment of children with NMS

Eligibility criteria: Inclusion Criteria:

* Children diagnosed with OI;
* Compliance with the diagnostic guidelines for Syncope in children (2016 edition) and 2018 syncope in children and adolescents in the cardiovascular group of the Society of Pediatrics, Chinese Medical Association The diagnostic criteria of Oi in the Diagnostic and therapeutic guidelines.

Exclusion Criteria:

* Taken 3 months prior to admission Vitamin D or hormone drugs;
* Heart, brain, nerves, metabolism, blood and other apparatus Syncope or aura of syncope caused by a qualitative disease;

Primary outcomes:
measure: Vitamin D levels
timeFrame: 3 months after taking the drug
Secondary outcomes:
measure: RAAS levels
timeFrame: 3 months after taking the drug
Other outcomes:
measure: OI symptom scores
timeFrame: 3 months after taking the drug
Locations:
city: Lanzhou
country: China
facility: Kongyujie
state: Gansu
Study officials:
affiliation: LanZhou University
name: xiangyu Dong, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01130857: Diagnostic Study of Temporal Arteritis
Official title: Diagnostic Tools in Temporal Arteritis - Towards the Development of a Diagnostic Algorithm
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Temporal Arteritis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-05-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients suspected of temporal arteritis and referred to temporal artery biopsy

Brief summary: Despite a large and growing body of knowledge concerning the diagnosis of temporal arteritis, this potentially crippling disease still requires pathological diagnosis in practically every case. It seems likely that a correctly estimated clinical probability could help in evaluating imaging results in a way that might safely obviate temporal biopsy in a large segment of suspect cases.

With this aim in view, we intend to identify useful clinical items and integrate them in an appropriate diagnostic pathway.


Eligibility criteria: Inclusion Criteria:

* Patients suspected of temporal arteritis and referred by their physicians to biopsy of a temporal artery.

Exclusion Criteria:

* Pregnancy; age \> 80 or \< 18; unable to answer study questions

Primary outcomes:
measure: Percent decrease in future biopsy use.
timeFrame: 2 years
Secondary outcomes:
measure: No secondary outcome.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center, Tel Aviv, ISRAEL
name: Israel SA Heller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184457: Maximal Leg Press Strength Training Study for Coronary Artery Disease Patients
Official title: Maximal Leg Press Strength Training for Coronary Artery Disease Patients. Training Effect on Serum Testosterone and Work Economy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Coronary Artery Disease
Keywords: Cardiac heart failure
Leg press
Maximal strength training
Serum testosterone
Work economy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2005-09-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Maximal strength training has been shown to increase muscular strength, muscular volume and work economy. An 8 week maximal leg press training regime will be conducted on cardiac heart failure patients to evaluate whether they increase their maximal leg press strength, work economy, serum testosterone and quality of life. The study hypotheses are that:

1. Aerobic work capacity will increase due to increased work economy, without increases in maximal oxygen uptake.
2. Strength training will increase serum testosterone.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed coronary artery disease
* Stable coronary artery disease
* 1.5 mm depression in ST segment during a cycling strain test
* Between 18-70 years of age

Exclusion Criteria:

* Unstable coronary artery disease
* Other limitations to exercise than coronary artery disease
* Participants in other study interventions

Primary outcomes:
measure: Maximal leg press strength
measure: Work economy
measure: Serum testosterone
measure: Quality of life
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Asbjørn Støylen, MD
role: STUDY_DIRECTOR
References:
citation: Karlsen T, Helgerud J, Stoylen A, Lauritsen N, Hoff J. Maximal strength training restores walking mechanical efficiency in heart patients. Int J Sports Med. 2009 May;30(5):337-42. doi: 10.1055/s-0028-1105946. Epub 2009 Feb 6.
Clinical trial NCT01661257: Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-α Therapy
Official title: Expression of T-cell Immunoglobulin- and Mucin-domain-containing Molecule 3 (TIM-3)and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-α Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's disease
Infliximab
T-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3)
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigated the expression of T-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3) in the colonic mucosa and/or the peripheral blood of children with Crohn's disease during anti TNF-α (infliximab) therapy.

Detailed description: The immunoregulatory effects of TIM-3 on patients with Crohn's disease according to the treatment have not yet been investigated.

Eligibility criteria: Inclusion Criteria:

* •Pediatric patients who were diagnosed with severe Crohn's disease who require infliximab treatment

  * confirmed diagnostic of Crohn's disease in clinical, endoscopic and histological findings

Exclusion Criteria:

* •patients who has proven to have infliximab antibody

Primary outcomes:
measure: Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease with anti TNF-α Therapy
timeFrame: 1-year treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT05188157: Mirror Therapy for Impingement Syndrome
Official title: Mirror Therapy is an Adjuvant Treatment Option Based on Shoulder Impingement Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impingement Syndrome
Mirror Movements 2
Keywords: mirror therapy
Impingement Syndrome
shoulder
adjuvant treatment
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Mirror therapy is an adjuvant treatment option based on shoulder impingement Syndrome Objective:To investigate the effect of mirror theraphy on shoulder impingement Syndrome Methods: The study included 62 participants, including cases in the intervention group (IG) (± years) and 20 cases in the control group (CG) (years) who met the selection criteria. IG received mirror theraphy with regular physiotherapy while CG received only regular physiotherapy. The patients were evaluated with the before treatment, immediately after treatment (post-treatment).


Eligibility criteria: Inclusion Criteria:

* Being aged 18-75 years
* Being diagnosed with shoulder impingement syndrome

Exclusion Criteria:

* Being uncooperative
* Having an additional systemic disease
* Having uncontrolled hypertension
* Presence of heart failure
* Having hearing or vision problems
* Having a balance disorder
* Diagnosis of heart disease and lung disease so advanced that exercise is contraindicated
* History of shoulder surgery
* Have any pathology that may cause referred pain (eg, cervical radiculopathy)
* Shoulder trauma, previous humeral fracture history
* Steroid injection to the shoulder joint or subacromial bursa in the last 6 months

Primary outcomes:
measure: goniometer
timeFrame: 10 minutes
measure: Hawkins test
timeFrame: 5 minutes
measure: Neer test
timeFrame: 5 minutes
measure: Jobe Test
timeFrame: 5 minutes
measure: Constant Murley Score
timeFrame: 10 minutes
measure: Tampa Kinesiophobia Scale
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
References:
Clinical trial NCT05383157: Brief Mindfulness Intervention for Chronic Pain in Ukraine
Official title: Brief Mindfulness Intervention for Chronic Pain in Ukraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Vinnitsa National Medical University
First posted: 2022-05-19
Enrollment: 150
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: This is a pragmatic randomized controlled trial comparing a single 15-minute mindfulness-based intervention to usual care for patients with chronic pain in Ukraine being seen in a pain clinic.


Eligibility criteria: Inclusion Criteria:

* Physician-confirmed chronic pain-related diagnosis

Exclusion Criteria:

* Cognitive impairment preventing completion of study procedures.
* Other unstable illness judged by medical staff to interfere with study treatment.

Primary outcomes:
measure: Pain intensity
timeFrame: Change from baseline to 20 minutes later.
Secondary outcomes:
measure: Pain unpleasantness
timeFrame: Change from baseline to 20 minutes later.
measure: Positive affect
timeFrame: Change from baseline to 20 minutes later.
measure: Desire for analgesic medication
timeFrame: Change from baseline to 20 minutes later.
measure: Anxiety
timeFrame: Change from baseline to 20 minutes later.
measure: Depression
timeFrame: Change from baseline to 20 minutes later.
Other outcomes:
measure: Decentering
timeFrame: Change from baseline to 20 minutes later.
measure: Self-transcendence
timeFrame: Change from baseline to 20 minutes later.
Locations:
city: Vinnitsa
country: Ukraine
facility: Vinnitsa National Medical University
Study officials:
References:
Clinical trial NCT01383057: Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery
Official title: Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataracts
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2011-06-28
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Study participants must have a cataract for which phacoemulsification extraction and posterior IOL implantation has been planned in at least one eye.
* Study participants should be capable of achieving better than 20/30 Snellen best corrected distance vision after cataract extraction and IOL implantation.

  * The surgeon may use the Mentor Potential Acuity Meter (PAM) laser interferometer, McIntyre Pinhole, or his/her judgment to estimate the patient's potential acuity.

Exclusion Criteria:

* Concurrent participation or participation in the last thirty days in any other clinical trial.
* Known steroid IOP responder
* Taking medications that may affect vision, IOP or ease of cataract surgery (e.g., Flomax, Glaucoma mediations, etc.)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
* Uncontrolled systemic or ocular disease
* Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies)
* Pseudoexfoliation
* Ocular hypertension IOP \>25 mmHg by tonometry or glaucomatous changes in the optic nerve

Primary outcomes:
measure: Intraocular Pressure
timeFrame: 3 months
measure: Uncorrected and Best corrected Visual Acuity
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Goodlettsville
country: United States
facility: Loden Vision Centers
state: Tennessee
Study officials:
References: