louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04912440: Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy
Official title: Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ercp in Altered Anatomy
Keywords: endoscopy
enteroscopy
ercp in altered anatomy
Lead sponsor: Evangelisches Krankenhaus Düsseldorf
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with surgically altered upper gastrointestinal anatomy and indication for endoscopic retrograde cholangio-pancreatography

Brief summary: Patients with surgically altered anatomy receiving Motorized Spiral Eneroscopy (MSE)-assisted ERCP at a single endoscopic reference center for various indications are planned to be retrospectively enrolled

Detailed description: All consecutive patients with altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery and indication for ERCP with biliary and/or pancreatic indication, who underwent routine Enteroscopy-assisted ERCP using MSE, at the study center during the study period, will be enrolled in the analysis.

Primary endpoint of the study will be efficacy and safety of MSE-assisted ERCP.

Retrospective epidemiologic Study (not interventional) was approved by local IRB and ethical committee of the North-Rhine Chamber of Physicians (Düsseldorf, Germany), Reference Number: 177/2021.

Eligibility criteria: Inclusion Criteria:

* altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery
* indication for ERCP with biliary and/or pancreatic indication
* Enteroscopy-assisted ERCP using MSE, at the study center during the study period

Exclusion Criteria:

- due to the retrospective design of the study, no exclusion criteria are defined

Primary outcomes:
measure: Success rate of MSE-ERCP
timeFrame: intraprocedural
measure: Adverse event rate of MSE-ERCP
timeFrame: 3 days
Secondary outcomes:
measure: Success rate of enteroscopy
timeFrame: intraprocedural
measure: Procedural duration
timeFrame: intraprocedural
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: Evangelisches Krankenhaus
Study officials:
affiliation: Evangelisches Krankenhaus Düsseldorf, Department of Gastroenterology and Therapeutic Endoscopy
name: Torsten Beyna, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schneider M, Hollerich J, Gerges C, Balasus N, Neuhaus H, Beyna T. Motorized spiral enteroscopy-assisted ERCP in surgically altered anatomy: early experience from a retrospective cohort study. Endoscopy. 2023 May;55(5):476-481. doi: 10.1055/a-1964-2100. Epub 2022 Oct 19.
Clinical trial NCT03920540: A Study of GC1111 in Hunter Syndrom Patients
Official title: Phase 3, Double-blind, Randomized, Active-controlled (Part 1) and Open-labeled, Historical Placebo Controlled (Part 2) Study to Evaluate the Efficacy of Hunterase (Idursulfase-beta) in Hunter Syndrome (Mucopolysaccharidosis II) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hunter Syndrome
Keywords: GC1111
Mucopolysaccharidosis II
MPS II
idursulfase-beta
IDS
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2019-04-19
Enrollment: 32
Sex: MALE
Minimum age (years): 5
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 is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Hunter syndrome
* Male at the age of ≥ 5
* Adequate abilities (including 6-MWT) to participate in this study in the opinion of the investigator.
* Voluntarily signed written informed consent to participation in this study
* Consent to contraception

Exclusion Criteria:

* Prior treatment with iduronate-2-sulfatase ERT
* History of bronchotomy, bone marrow trasplanation, or cord blood transplanation.
* Known hypersensitivity reactions to any of the components of the invetigational product
* Prior or planned administration of other investigational products within 30 days before treatment with the investigational product in this study or duirng this study.
* Unable to perform 6-MWT.
* Female

Primary outcomes:
measure: Change in 6-MWT
timeFrame: at Week 53 from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsug Medical Center
Study officials:
affiliation: Samsung Medical Center
name: DongKyu Jin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06575140: Associative Peripheral Stimulation for Reduction of Motor Impairment During Acute Period of Stroke Recovery
Official title: Pilot Randomized Controlled Trial Assessing Associative Peripheral Stimulation (APS) for Reduction of Motor Impairment During Acute Period of Stroke Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Stroke, Acute
Stroke, Ischemic
Stroke, Hemorrhagic
Hemiparesis
Hemiparesis;Poststroke/CVA
Weakness of Extremities as Sequela of Stroke
Stroke Sequelae
Upper Extremity Paresis
Keywords: Stroke Rehabilitation
Associative Peripheral Stimulation
Lead sponsor: APS Trial Group
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Associative Peripheral Stimulation (APS) is a non-invasive therapy intended for stroke rehabilitation involving transcutaneous electrical muscle stimulation paired with voluntary movement. This pilot study investigates whether APS applied during the acute phase of stroke recovery may reduce impairment and improve function in the affected upper extremity.


Eligibility criteria: Inclusion Criteria:

1. Confirmed ischemic or hemorrhagic stroke no earlier than 7 days prior to enrollment;
2. Presentation of hemiparesis or paralysis of the upper extremity due to stroke;
3. Ability to comprehend and follow study instructions;
4. Ability to initiate finger extension (≥3°) at least three times per minute;
5. Fugl-Meyer Assessment (Upper Extremity) score of \<47.

Exclusion Criteria:

1. Contraindications, intolerance, or high sensitivity to the experimental protocol;
2. History of upper-extremity disability prior to the index stroke;
3. Neurological conditions (other than stroke) affecting motor function;
4. Treatment of spasticity/increased tone in the affected upper extremity (e.g., with Botox injection);
5. Lack of access to a safe and suitable place of discharge for experimental sessions and follow-up visits.

Primary outcomes:
measure: Maximum Average of Range of Motion (ROM)
timeFrame: 5 weeks
measure: Fugl-Meyer Assessment Upper-Extremity (FMA-UE)
timeFrame: 5 weeks
Secondary outcomes:
measure: Maximum Average of Range of Motion (ROM)
timeFrame: 3 months
measure: Fugl-Meyer Assessment Upper-Extremity (FMA-UE)
timeFrame: 3 months
measure: Action Research Arm Test (ARAT)
timeFrame: 5 weeks
measure: Action Research Arm Test (ARAT)
timeFrame: 3 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: General Hospital of Mexico
city: Mexico City
country: Mexico
facility: La Raza National Medical Center
city: Mexico City
country: Mexico
facility: National Institute of Neurology & Neurosurgery
Study officials:
affiliation: National Institute of Neurology & Neurosurgery
name: Daniel San Juan Orta, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04505540: Start Treatment and Recovery for Opioid Use Disorder
Official title: Effectiveness of Bridge Clinic Following Emergency Department-Initiated Intervention for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Mental Disorder
Opioid Medication Assisted Treatment
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Substance Abuse and Mental Health Services Administration (SAMHSA)
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-08-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is 1) to evaluate whether emergency department-initiated medically assisted treatment with Buprenorphine/Naloxone in patients presenting with opioid use disorder will produce positive outcomes at 1 week, 3 months and 6 months after treatment initiation.

Detailed description: The emergency department is a critical missed opportunity to engage patients with opioid use disorder in medication-assisted treatment, the most effective current treatment for the disorder. Patients presenting at the emergency department with opioid use disorder will be given the opportunity to immediately start medication assisted treatment with Naloxone/Buprenorphine then referred either to a specialized addiction bridge clinic or a local waivered provider for further treatment.

Eligibility criteria: Inclusion Criteria:

* Patient at Emergency Department
* Diagnosis opioid use disorder according to criteria Diagnostic and Statistical Manual (DSM) 5

Exclusion Criteria:

* Participating in alternate treatment program for opioid use disorder
* Prisoner
* Inability to communicate
* Psychosis
* Suicidality
* History of Buprenorphine injection
* Critical Illness

Primary outcomes:
measure: Number of Participants With Self-reported Treatment Retention
timeFrame: 1 week
measure: Number of Participants With Self-reported Treatment Retention
timeFrame: 3 months
measure: Number of Participants With Self-reported Treatment Retention
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Illicit Opioid Use
timeFrame: 1 week
measure: Number of Participants With Illicit Opioid Use
timeFrame: 3 months
measure: Number of Participants With Illicit Opioid Use
timeFrame: 6 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
References:
Clinical trial NCT06196840: Safety and Efficacy of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)
Official title: A Phase 2, Randomized Controlled, Open-Label Study to Establish the Safety and Efficacy of LX102 in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: Age-related macular degeneration
AMD
Neovascular AMD
Neovascular age-related macular degeneration
Lead sponsor: Innostellar Biotherapeutics Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD.

Detailed description: In this Phase 2, multi-center, randomized controlled study, subjects will be randomized to receive one of the two dose levels of LX102 (n=20 for each dose level), or aflibercept (n=10).

Safety, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.

Eligibility criteria: Inclusion Criteria:

1. Willing to sign the informed consent, and willing to attend follow-up visits.
2. Age ≥ 50, and ≤ 89.
3. Diagnosis of active CNV secondary to neovascular AMD.
4. BCVA ETDRS letters between 19 and 73.
5. Demonstrated a meaningful response to anti-VEGF therapy.

Exclusion Criteria:

1. CNV or macular edema in the study eye secondary to diseases other than nAMD.
2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement.
3. Absence of RPE tear at Screening.
4. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months.
5. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg.
6. Uncontrolled diabetes defined as HbA1c \>8.0%.

Primary outcomes:
measure: Mean change from baseline in Best Corrected Visual Acuity (BCVA)
timeFrame: 36 weeks
Secondary outcomes:
measure: Mean change from baseline in Best Corrected Visual Acuity (BCVA)
timeFrame: 52 weeks
measure: Mean change in Central Subfield Thickness (CST) from Baseline
timeFrame: 36 weeks, 52 weeks
measure: Durability of LX102 treatment
timeFrame: 52 weeks
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 36 weeks, 52 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hangzhou
country: China
facility: Zhejiang University Eye Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai General Hospital
Study officials:
References:
Clinical trial NCT01397240: The Safety and Efficacy of Albis®: The Prevention of Aspirin-induced Gastrointestinal Ulcers in Patients
Official title: The Safety and Efficacy of Albis®: The Prevention of Aspirin-induced Gastrointestinal Ulcers in Patients Taking Low-dose Aspirin, A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Patients Taking Low-dose Aspirin
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2011-07-19
Enrollment: 80
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 research the safety and efficacy of Albis® for the prevention of aspirin-induced gastrointestinal ulcers in patients taking low-dose aspirin.

Detailed description: The Safety and Efficacy of Albis®: The Prevention of Aspirin-induced Gastrointestinal Ulcers in Patients taking Low-dose Aspirin, A pilot study Double-Blind, Placebo-Controlled, Randomized, Multicenter, Parallel, Prospective study

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 20 to 80 years
* Subjects identified with at least one of the following diagnosis (Angina, Myocardial Infarction(Old), Cerebrovascular Disease, Peripheral Vascular Disease, Diabetes, Hypertension, Hypercholeseterolemia, Obesity) who are required to take a low dose of Aspirin (100mg/day) for more than 12 weeks.

Exclusion Criteria:

* Females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential
* Peptic ulcer or Reflux oesophagitis
* hemostatic disorder or coagulation disorder
* Known allergy or hypersensitivity to the study medication

Primary outcomes:
measure: Incidence rate of Gastric Ulcer
timeFrame: 2 years
Secondary outcomes:
measure: Incidence rate of gastiritis
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Hyo Jin Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06168240: The Effect of Manual Lymphatic Drainage on Acute and Post-acute Ankle Sprain in Athletes
Official title: THE EFFECT OF MANUAL LYMPHATIC DRAINAGE ON ACUTE AND POST-ACUTE ANKLE SPRAIN IN ATHLETES
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ankle Sprains
Keywords: Ankle sprain
Athletes
Manual lymphatic drainage
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Manual lymphatic drainage techniques (MLDTs) are special techniques in manual therapy used in rehabilitation for treatment of physical dysfunctions and pathologies. Such practices could be done by medical team or clinicians. Theories on MLDTs address functions like stimulating the lymphatic system by increasing lymph circulation, facilitating the removal of waste products from body tissues, reducing edema, and decreasing the responses of sympathetic nervous system while increasing the parasympathetic nervous tone leading to a relaxed body state.

Detailed description: This study will examine the effect of manual lymphatic drainage on pain intensity, ankle swelling, range of motion, static and dynamic functional stability in acute and post-acute ankle sprain in athletes.

Edema treatment includes a variety of techniques; elevation, compression, electrical stimulation, ultrasound, and massage are a few of them. Profound clinical check is required to determine the kind of edema management. However, the effect of these techniques on the lymphatic system and the edema itself is questionable. Manual Lymphatic Drainage mechanism, although still under investigation, is also a valid treatment management that does not cause inflammation, reduces the absorption of waste products and excess fluid and still urges the lymphatic system to work better.

Eligibility criteria: Inclusion Criteria:

1. . Basketball Athletes patients diagnosed as acute and post-acute ankle sprain. 2. Patients within 18 and 30 years old. 3. Patients with grade I, II ankle inversion sprain. 4. All participants complains of pain and moderate swelling in the ankle.

Exclusion Criteria:

1. Previous ankle surgery.
2. Serious pathology.
3. History of fractures in the ankle joint.
4. Vascular disorders.
5. Grade III ankle sprain.

Primary outcomes:
measure: static balance
timeFrame: starting and after 4 weeks
measure: dynamic postural balance
timeFrame: starting and after 4 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: starting and after 4 weeks
measure: swelling
timeFrame: starting and after 4 weeks
measure: range of motion
timeFrame: starting and after 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03962140: CT Assessment of BMI in Endometrial Cancer Patients
Official title: Computed Tomography Assessment of Body Fat Distribution in Endometrial Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Keywords: Endometrial Cancer
CT-scan
Fat distribution
Obesity
Sarcopenia
Lead sponsor: Royal Cornwall Hospitals Trust
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 302
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Endometrial cancer patients

Brief summary: This study is a retrospective study to investigate the association between body fat distribution and sarcopenia on CT-scan and oncological outcomes in endometrial cancer patients


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of endometrial cancer
* Age: 18 years or older
* Abdominal CT-scan as part of pre-operative or post-operative staging work-up (\<1 month after surgery)

Exclusion Criteria:

* Women with concurrent cancer
* Women with unknown body mass index

Primary outcomes:
measure: The Investigation of Patients with High BMI and Survival Rates
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
Study officials:
References:
Clinical trial NCT05622240: 99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer
Official title: 99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: SPECT/CT
HER2
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 30
Sex: FEMALE
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the imaging performance of 99mTc-MIRC213 in breast cancer patients. A single dose of 11.1-14.8Mega-Becquerel (MBq) per kilogram body weight 99mTc-MIRC213 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

Detailed description: 99mTc-MIRC213 is an nano affibody probe targeting HER2. The investigators will determine the use of 99mTc-MIRC213 SPECT/CT in the detection of HER2- positive breast cancer, and to compare its diagnostic value with routine immunohistochemistry (IHC) pathological staining. HER2 imaging, specifically to HER2 receptor expressed on malignant breast cancer cell surface, might help for targeted therapy with monoclonal antibody such as trastuzumab in breast cancer, and may improve the treatment strategy of breast cancer. The investigator will determine the use of 99mTc-MIRC213 SPECT/CT in stratifying breast cancer.

Eligibility criteria: Inclusion Criteria:

* patients in suspicion of breast cancer by mammography or ultrasonography,and being able to provide basic information and sign the written informed consent form

Exclusion Criteria:

* The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with HER2 binding.

Primary outcomes:
measure: Dosimetric distribution of radiopharmaceuticals
timeFrame: 2 months
measure: Standardized uptake value
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events collection
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhaohui Zhu, Dr
role: STUDY_CHAIR
References: