louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00854230: Pharmacotherapy for HIV Infected Patients With Alcohol Problems
Official title: Pharmacotherapy for HIV Infected Patients With Alcohol Problems
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: HIV Infection
Heavy Alcoholic Consumption
HIV Infections
Keywords: HIV
alcohol
naltrexone
Treatment Experienced
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
Collaborators: name: Yale University
First posted: 2009-03-03
Enrollment: 0
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: This is a randomized double blind clinical trial to test the effect of Naltrexone on HIV infected heavy drinkers. The study will select 40 HIV positive patients who meet criteria for heavy drinking. Treatments include Naltrexone (25-100mg)and placebo. Patients will be treated, followed up, and assessed for a duration of 12 weeks.

The investigators associated hypotheses Hypothesis 1: Naltrexone will reduce the frequency of heavy drinking. Hypothesis 2: Naltrexone will lead to maintenance or improvement in CD4 lymphocyte count and decreased HIV RNA levels.

Hypothesis 3: Naltrexone will lead to a reduction in sexual risk behaviors. Hypothesis 4: Naltrexone will lead to improved adherence to HAART. Hypothesis 5 (Exploratory): Naltrexone will be well-tolerated with minimal side effects and patients will exhibit good treatment retention.


Eligibility criteria: Inclusion Criteria:

1. Be HIV-positive.
2. Report heavy drinking 4 or more times in the past 4 weeks. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on any occasion.
3. Not be abstinent from alcohol for greater than 30 days.
4. Be at least 18 years old.
5. Be able to understand English and provide informed consent

Exclusion Criteria:

1. Be psychotic or severely psychiatrically disabled.
2. Have medical conditions that would preclude completing or be of harm during the course of the study.
3. Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of the normal range) or cirrhosis.
4. Have a known contraindication to naltrexone therapy (e.g. taking opioid medication for pain).
5. Be pregnant, nursing or unable to use an effective method of birth control (women).
6. Subjects who are taking or use narcotics will not be included because naltrexone will precipitate withdrawal.

Primary outcomes:
measure: Frequency of heavy drinking
timeFrame: 12 weeks
Secondary outcomes:
measure: HIV biological markers
timeFrame: 12 weeks
measure: Sexual risk behavior
timeFrame: 12 weeks
measure: Tolerability and retention in alcohol treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: David A Fiellin, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University, West Haven VA hospital
name: Amy Justice, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02347930: Establish and Apply the Evaluation System of Ultrasonic Integrated Technology for Prevention and Treatment of Acute Kidney Injury
Official title: Establish and Apply the Evaluation System of Ultrasonic Integrated Technology for Prevention and Treatment of Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
ultrasound technology
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: National Cheng-Kung University Hospital
First posted: 2015-01-28
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Confirmed acute kidney injury

Brief summary: Establish an integrated evaluation system of ultrasound technology for the prognosis of acute kidney injury, and in order to achieve non-invasive, reliable early diagnosis "gold standard". Set up collabration with the expert in National Cheng Kung University Medical Center of Taiwan who did a lot of excellent work in basic research of prevention the progression of acut kidney injury. Study the experience about prevention progression of kidney disease in clinical and basic field. Establish cooperation with the professional in Hong Kong University of Science and Technology. To set up the system of natural products research and assess the Astragalus medicinal value.


Eligibility criteria: Inclusion Criteria:

* Subjects must satisfy the following criteria to be enrolled in the study:

  1. Clinical diagnosis of acute or chronic kidney injury
  2. Male or female, aged 18-80 years old
  3. signed informed consent
  4. Patients can breathe in, breathe out and hold their breathe with ease, communication without difficulty.

Exclusion Criteria:

* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Refuse to sign informed consent
  2. allergy to micro bubble hexafluoride drug
  3. Patients with cardiopulmonary insufficiency, pleural effusion, pulmonary infections
  4. Patients with asthma, chronic bronchitis
  5. Patients with pregnancy
  6. Patients can't cooperate or have a difficulty in breathing in, breathing out or holding their breathe
  7. Patients beening diagnosed with End-stage kidney disease.

Primary outcomes:
measure: compare the results of kidney ultrasound with biomarkers of acute kidney injury
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of nephrology , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
name: shan mou, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06925230: Arthroscopic Assisted Volar, Dorsal or Combined Capsulodesis in Scapholunate Ligament Injury.
Official title: Arthroscopic Assisted Volar, Dorsal or Combined Capsulodesis in Scapholunate Ligament Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scapholunate Interosseous Ligament Injury
SLLI
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this case series study is to test the efficacy of arthroscopic assisted volar, dorsal or combined scapholunate capsulodesis in the management of scapholunate ligament injuries.

Detailed description: The aim of this case series study is to test the efficacy of arthroscopic assisted volar, dorsal or combined scapholunate capsulodesis in the management of scapholunate ligament injuries. All patients will be assessed preoperatively by careful history taking , full general and local examination and radiological evaluation using wrist plain X-rays (Standard PA, clenched-fist PA , PA in ulnar deviation , lateral projection in neutral ,flexion and extension ) and wrist Magnetic resonance imaging.an informed written consent was taken before any surgery. The procedure starts with a standard radiocarpal and then midcarpal arthroscopy. During the arthroscopic examination ,several factors are assessed, including the location of the SLIL injury (volar, membranous, dorsal, or complete), the condition of the cartilage, the reducibility of the carpus, and other associated pathologies like TFCC injury. Classification is done using Geissler Classification, Garcia Elias Classification and EWAS classification.Volar capsulodesis using Hayman Lui et al or Del Pinal et al method and/or dorsal capsulodesis using original Mathoulin technique or combined capsulodesis were done.

Eligibility criteria: Inclusion Criteria:

* Sex: both sexes.
* Age: above 18 years
* Lesion: subacute or chronic scapholunate ligament injury
* partial and complete SLIL tears

Exclusion Criteria:

* Acute scapholunate ligament injury
* irreducible carpal malalignment
* posttraumatic arthritis
* associated fractures that could affect the functional outcome

Primary outcomes:
measure: wrist range of motion
timeFrame: preoperative and postoperative after 3months , 6months , 9months and 12months
Secondary outcomes:
measure: scapholunate gap
timeFrame: preoperative and postoperative scapholunate gaps after 3months , 6months , 9months and 12months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbassia
Study officials:
References:
Clinical trial NCT03758430: A Study of Technology to Improve Glucose Control in Participants With Type 1 Diabetes
Official title: Technology-supported, Meal-centric, Insulin Dosing for Optimized Post-prandial Glucose Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Joslin Diabetes Center
First posted: 2018-11-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with T1D

Brief summary: The main purpose of this study is to determine whether combining meal, glucose, and insulin data in a web-based system will improve management of type 1 diabetes (T1D). No study drug will be given. The study will last about 18 weeks.


Eligibility criteria: Inclusion Criteria:

* T1D by clinical diagnosis for \> 3 years
* Insulin pump use \> 3 months: must use one of the following pump types: Animas Ping and Vibe, Insulet Omnipod, Medtronic 523/723 and 530G, Tandem t:slim and t:flex
* Continuous Glucose Monitor (CGM) \> 3 months and current use of Dexcom G5 at least 6 out of 7 days per week
* HbA1c 7.0-9.5%
* Must have iPhone (meal-tagging app has been built on iOS)
* Personal computer for uploading of pump and CGM devices
* Willingness to follow study protocol including tagging food data
* Comfort speaking, reading, and writing English

Exclusion Criteria:

* Individuals currently using a hybrid closed-loop system (e.g., Medtronic 670G)
* Individuals planning to follow a specific diet plan for weight loss
* Inability to consume "common meals"
* Gastroparesis;
* Eating disorder
* Evidence of missed insulin meal-time insulin boluses on pump download
* Use of medications that can affect blood glucose levels (such as SGLT inhibitors, steroid, beta agonists)
* Use of medications that affect gastric emptying (such as GLP agonists, pramlinitide)
* Alcohol abuse
* Pre-conception, pregnancy, or lactation

Primary outcomes:
measure: Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02861430: Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology
Official title: Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Lymph Node
Sentinel Node
Keywords: colon cancer
sentinel node
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 48
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: Colon cancer

Brief summary: Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for non metastatic colon cancer.


Eligibility criteria: Inclusion Criteria:

* Colectomy for Non metastatic colon cancer

Exclusion Criteria:

* Tumor T4
* No medical insurance
* Pregnant woman
* Psychiatric disorders

Primary outcomes:
measure: Concordance between immunochemistry and molecular biology
timeFrame: 1 month
Secondary outcomes:
measure: Disease-free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHRU Besancon
Study officials:
References:
Clinical trial NCT06111625: Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL
Official title: Short-term Blinatumomab as a Bridge Therapy for Hematopoietic Stem Cell Transplantation in B-cell Acute Lymphoblastic Leukemia With Low Leukemia Burden
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Leukemia, Lymphoid
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this single-arm, prospective study is to test in low-burden B-cell lymphoblastic leukemia (B-ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:

• The efficacy and safety of short-term blinatumomab as a bridging therapy to allo-HSCT in patients with low-burden B-ALL. Participants will take intravenous blinatumomab prior to allo-HSCT with an initial dosage of 8 μg/day. The dosage gradually escalated to 28 μg/day and continued for 5 to 10 days. Dexamethasone 20mg was administered 1 hour before the onset of blinatumomab infusion.


Eligibility criteria: Inclusion Criteria:

1. patients diagnosed with B-ALL;
2. patients with age ≥ 16 years;
3. Availability of both pre- and post-transplantation disease status records.

Exclusion Criteria:

1. administration of blinatumomab therapy for more than 14 days;
2. patients with leukemia burden ≥ 10% before initiation of treatment;
3. patients with severe organ dysfunctions before treatment, including myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal dysfunction, or gastrointestinal dysfunction;
4. patients with central nervous system leukemia.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 2 years
measure: Relapse rate
timeFrame: 2 years
measure: Cumulative incidence of acute graft versus host disease (aGVHD)
timeFrame: Day +100
measure: Cumulative incidence of chronic graft versus host disease (cGVHD)
timeFrame: 2 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT04992325: AS-OCT Study in Diabetic Retinopathy
Official title: Anterior Segment- Optical Coherence Tomography as Early Biomarker in Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 50 years with previous diagnosis of type 2 diabetes mellitus without signs of diabetic retinopathy.

The participans did not present other ophthalmological diseases

Brief summary: This study evaluates the corneal features using anterior segment - optical coherence tomography in patients affected by type 2 diabetes mellitus

Detailed description: To investigate the potential role of anterior segment-optical coherence tomography (AS-OCT) in identifying the corneal changes (in particular in total corneal, epithelial and stromal thicknesses) in patients affected by type 2 diabetes mellitus, without signs of diabetic retinopathy at fundus examination.

The AS-OCT could represents a valid early biomarker in these patients.

Eligibility criteria: Inclusion Criteria:

* age older than 50 years
* diagnosis of previous type 2 diabetes mellitus
* absence of signs of diabetic retinopathy
* absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* absence of significant lens opacities, low-quality OCT and OCT-A images

Exclusion Criteria:

* age younger than 50 years
* absence of previous diagnosis of type 2 diabetes mellitus
* presence of signs of diabetic retinopathy
* presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* presence of significant lens opacities, low-quality OCT and OCT-A images.

Primary outcomes:
measure: The measurements of corneal features in patients with type 2 diabetes mellitus, using anterior segment-optical coherence tomography
timeFrame: twelve months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: Federico II University
name: Gilda Cennamo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01310725: Evaluation of Graft Material in Coronary Artery Bypass Grafting (CABG)
Official title: Mid-term Patency of Radial Artery and No Touch Saphenous Vein as Grafts in CABG; A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angina Pectoris
Keywords: CABG
LIMA
saphenous vein
radial artery
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Swedish Heart Lung Foundation
name: Regional Clinical Research
First posted: 2011-03-08
Enrollment: 108
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the patency in different kinds of vessels used as graft material in coronary artery bypass grafting.

The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the same, or better, patency compared to radial grafts and that skeletonisation of the left internal mammary artery does not effect the patency for this graft.

Detailed description: Patients undergoing coronary artery bypass grafting are included in the study.

Each patient receive a radial artery graft and a vein graft harvested with a pedicle of surrounding tissue to the right and left side of the heart respectively. The left internal mammary artery is used for the left anterior descending artery in a skeletonised or non-skeletonised fashion.

The evaluation is made with angiography up to 5 years after surgery.

Eligibility criteria: Inclusion Criteria:

* Isolated coronary artery disease embracing all three main branches of the coronary artery tree.

Exclusion Criteria:

* Kidney insufficiency (Creatinine \> 120 µmol/L)
* War-farin anticoagulation therapy
* Ejection fraction \< 40%
* Repeat operation
* Other concurrent sur-gery
* Signs of reduced circulation in non-dominant hand
* Other severe illness, or if the patient declines to participate.

Primary outcomes:
measure: Functional grafts defined as opened or closed.
timeFrame: Up to 5 years after surgery.
Secondary outcomes:
measure: Degree of stenosis in implanted grafts.
timeFrame: Up to 5 years after surgery.
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: Dept of Cardiothoracic Surgery, Orebro University Hospital
Study officials:
affiliation: OREBRO UNIVERSITY
name: Lars Norgren, MD, PhD, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT04116125: Omitting Biopsy of SEntinel Lymph Node With Radiation After Neoadjuvant Chemotherapy in Breast Cancer (OBSERB) Trial
Official title: A Randomized Trial of Sentinel Lymph Node Biopsy vs Radiotherapy Alone After Neoadjuvant Chemotherapy in Patients Undergoing Breast Conserving Surgery With cT1-3N1, ycN0 Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Neoplasm Female
Lymphatic Metastasis
Keywords: Breast cancer
cN1, ycN0
Neoadjuvant cheotherapy
Sentinel Lymph Node
Radiotherapy
Lead sponsor: Kyungpook National University Chilgok Hospital
Sponsor class: OTHER
Collaborators: name: Korean Breast Cancer Study Group
First posted: 2019-10-04
Enrollment: 1380
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The OBSERB study is a multi-center, non-blinded, pragmatic, parallel, randomized controlled trial in which patients with cT1-3N1 and ycN0 breast cancer.

Detailed description: The OBSERB study aims to compare the oncologic outcomes of radiotherapy without sentinel lymph node biopsy versus sentinel lymph node biopsy for the management of breast cancer which showed the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.

To verify whether, the radiotherapy without SLN can be applied, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.

To verify whether, the additional treatment decision can be established based on only the biology of primary tumor without the pathologic information of axillary lymph nodes To verify whether, the patients' quality of life can be improved by a less invasive surgical procedure, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.

Eligibility criteria: Inclusion Criteria:

1. women aged \> 20 years
2. cT1-3N1M0, primary invasive
3. initially confirmed ALN by fine needle aspiration cytology before neoadjuvant chemotherapy
4. completion of neoadjuvant chemotherapy
5. tumors negative for LN metastasis confirmed by imaging after neoadjuvant chemotherapy

Exclusion Criteria:

1. synchronous distant metastases
2. previous other malignancy
3. bilateral breast cancer
4. previous primary systemic therapy
5. pregnancy or breastfeeding
6. pre-operative radiological evidence of multiple involved or suspicious axillary nodes
7. patient with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.

Primary outcomes:
measure: Disease-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Local recurrence
timeFrame: 5 years
measure: Axillary recurrence
timeFrame: 5 years
measure: distant recurrence
timeFrame: 5 years
measure: distant free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Other outcomes:
measure: Quality of life by questionnaire
timeFrame: 5 years
Locations:
Study officials:
References: