louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03408106: Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
Official title: Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV+ patients 21 years of age or older

Brief summary: Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients

Detailed description: This is a prospective study to evaluate the safety of donor nephrectomy in HIV+ individuals who donate kidneys to HIV+ candidates in need of transplant . The study will assess potential complications of HIV + living donors - including adverse events related to nephrectomy, development of chronic kidney disease, hypertension, and HIV-related complications.

Eligibility criteria: Inclusion Criteria:

* Able to understand and provide consent
* Age 21 years or older
* Meets standard clinical criteria for living donation per Johns Hopkins University (JHU) Comprehensive Transplant Center Policy
* Documented HIV infection (by any licensed Enzyme-linked Immunosorbent Assay (ELISA) and confirmation by Western Blot, positive HIV Ab Immunofluorescent Assay (IFA), or documented history of detectable HIV-1 RNA)
* CD4+ T-cell count ≥ 500/µL for 6 months prior to donation
* HIV-1 RNA below 50 copies RNA/mL (viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \>200 copies/mL)

Exclusion Criteria:

* Two high risk alleles of APOL1 (G1 or G2 variants)
* Hypertension
* Diabetes
* Chronic active hepatitis C (detectable HCV RNA in plasma)
* Evidence of invasive opportunistic complications from HIV infection
* Mentally incompetent and/or inability to provide informed consent
* Other medical conditions, as determined by the provider, that would preclude donation

Primary outcomes:
measure: Adverse events
timeFrame: at 1 year
Secondary outcomes:
measure: chronic kidney disease
timeFrame: through to study completion, up to 4 years
measure: hypertension
timeFrame: through to study completion, up to 4 years
measure: change in antiretroviral therapy
timeFrame: through to study completion, up to 4 years
measure: HIV virologic control
timeFrame: through to study completion, up to 4 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Christine Durand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03314506: Adipose Tissue Cellular Response to Exercise in Healthy Humans
Official title: Adipose Tissue Cellular Response to Exercise in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disease
Adipose Tissue
Keywords: exercise
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure the effects of a single session of exercise on changes in the cellular composition of the body fat of humans.

Detailed description: Fat tissue is far more than just a place where humans store body fat. Fat tissue contains many different types of cells, such as immune cells, endothelial cells, and fat precursor cells. Differences or changes in the number of immune cells, endothelial cells, and fat precursor cells in fat tissue can have a great impact on metabolic health. The abundance of all immune cells, endothelial cells, and fat precursor cell types are known to change when a person loses or gains weight. For example, the abundance of inflammatory cells is often found to decrease markedly with weight loss - and this change has been linked to the profound improvements in metabolic health that occur with weight loss. In contrast, the effects of exercise on immune cells, endothelial cells, and fat precursor cells in fat tissue is not known. Determining the effects of exercise on changes in the cellular composition within fat tissue will provide important information for optimizing lifestyle interventions aimed at improving metabolic health.

Eligibility criteria: Inclusion Criteria:

* Age: 18-40
* Body Mass Index: 20-27 kg/m2
* Regular exercise (less than or equal to 3 days/week of aerobic exercise; 30-60 minutes/session at moderate and vigorous intensities)
* Women must have regularly occurring menses and must be premenopausal

Exclusion Criteria:

* Blood pressure greater than 140/90 mm Hg
* Pregnant or lactating
* Evidence/history of cardiovascular or metabolic disease
* Medications known to affect lipid or glucose metabolism, or inflammation

Primary outcomes:
measure: Quantifying the change in markers of macrophage abundance in adipose tissue
timeFrame: 1 day
Secondary outcomes:
measure: Quantifying the change in markers of endothelial cell and pre-adipocytes in adipose tissue
timeFrame: 1 day
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeffrey F Horowitz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06834906: Usability User Testing of the Easy-EyeFM AI Platform
Official title: Usability User Testing of the Easy-EyeFM AI Platform
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ocular Diseases
Lead sponsor: Tsinghua University
Sponsor class: OTHER
Collaborators: name: First Hospital of Tsinghua University
name: Beijing Tsinghua Changgeng Hospital
name: University of Warmia and Mazury
name: University of Ghana
name: Augenarzt-Praxisgemeinschaft Gutblick AG
name: Huadong Sanatorium
name: University of Melbourne
name: Chinese University of Hong Kong
name: Sankara Nethralaya
name: Hanyang University Guri Hospitall
name: Department of Medical Services Ministry of Public Health of Thailand
name: Moorfields Eye Hospital NHS Foundation Trust
First posted: 2025-02-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Easy-EyeFM is a code-free artificial intelligence platform designed for ophthalmologists to provide diagnostic and treatment recommendations and help doctors develop customized diagnostic models.

This project aims to evaluate the usability and user-friendliness of the Easy-EyeFM platform for physicians. The study will gather feedback from medical professionals to evaluate the intuitiveness and effectiveness of the platform in supporting model customization and medical image analysis tasks.

Subjects will participate in the trial of the Easy-EyeFM platform and the comparison with the existing commercial platform (AutoML) at the appointed time. The researchers will inform subjects of relevant precautions and assist them to read the user manual before the test. Subjects will complete model customization and picture diagnosis within the prescribed test time, and according to the test results, Score the human-computer interaction experience of the AI platform, fill in the questionnaire, and finally complete the evaluation content.


Eligibility criteria: Inclusion Criteria:

* Medical students or doctors
* Have enough time to participate in this program, about 1 hour continuous assessment
* Agree to sign the informed consent form

Exclusion Criteria:

* Poor computer and mobile phone use and reading ability
* Poor language expression or dialect category is not included in the speech recognition function of the platform

Primary outcomes:
measure: System Usability Scale
timeFrame: 1 day
Secondary outcomes:
measure: Usage Time
timeFrame: 1 day
measure: Users Assistance Requests Times
timeFrame: 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tsinghua University
Study officials:
affiliation: Tsinghua University
name: Tien Yin Wong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03218306: Surgical Pleth Index (SPI) Versus Standard Clinical Approach Analgesia
Official title: Surgical Pleth Index Guided Intraoperative Analgesia Versus Standard Clinical Approach During Desflurane Based General Anesthesia for Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Pain
Surgery
Keywords: SPI
Remifentanil
Target controlled infusion
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is aimed at confronting a surgical pleth index based protocol for intraoperative analgesia in a desflurane based general anesthesia for thyroidectomy, versus a standard clinical approach. A reduction in analgesic consumption and improvement in hemodynamics are expected.


Eligibility criteria: Inclusion Criteria:

* 18\<age\<80 years
* American society of anesthesiology (ASA) physical status I -II
* 6 hrs fasting

Exclusion Criteria:

* Arrhythmia or Pacemaker
* Central or peripheral nervous system or muscular disease
* Drugs active on autonomous nervous system (eg clonidine)
* Obesity (BMI \>35)
* Chronic Pain
* Addictions or central nervous acting drugs use
* Hypertension (if not treated)
* Connective tissue disease
* Pregnancy
* Allergy or hypersensitivity to study drugs
* QT prolongation
* Absence of inclusion criteria

Primary outcomes:
measure: Remifentanil consumption
timeFrame: Intraoperative
Secondary outcomes:
measure: Hemodynamics
timeFrame: intraoperative
measure: Desflurane
timeFrame: intraoperative
measure: Extubation delay
timeFrame: intraoperative
measure: Post-operative analgesia 1
timeFrame: 24 hr post operative
measure: Post-operative analgesia 2
timeFrame: 24 hr post operative
measure: Adverse reactions
timeFrame: 24 hr post operative
measure: Patient satisfaction
timeFrame: 24 hr post operative
Other outcomes:
Locations:
city: Monserrato
country: Italy
facility: Policlinico Duilio Casula
state: Cagliari
Study officials:
affiliation: University of Cagliari
name: Gabriele Finco, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02197806: Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Presbyopia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-07-23
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus for near vision).


Eligibility criteria: Inclusion Criteria:

-Presbyopia in each eye that impacts daily activities.

Exclusion Criteria:

* Use of any topical ophthalmic medications, including artificial tears
* Contact lens use in either eye within 14 days or planned use during the study
* History of eye surgery
* Diagnosis of any type of glaucoma or ocular hypertension

Primary outcomes:
measure: Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye
timeFrame: Baseline, Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01759706: Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy
Official title: Safety and Feasibility Study of an Enhanced Recovery After Surgery Protocol in Patients Undergoing Elective Pancreaticoduodenectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasms
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
Collaborators: name: Ospedale San Raffaele
First posted: 2013-01-03
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the adherence to an enhanced recovery after surgery (ERAS) pathway and the impact of the ERAS protocol on postoperative short-term outcome in patients undergoing pancreaticoduodenectomy (PD).

Detailed description: A specific enhanced recovery after surgery (ERAS) protocol has been applied since October 2010 in consecutive patients undergoing pancreaticoduodenectomy (PD) in a high volume Institution. Patient compliance for each item has been assessed. Each ERAS patient was matched with a patient who received standard perioperative care. Match criteria were age, gender, malignant / benign disease, and PD prognostic score.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing elective pancreaticoduodenectomy

Exclusion Criteria:

* Intraoperative detection of metastatic disease (non-operability)

Primary outcomes:
measure: Adherence to the pathway
timeFrame: Participants will be followed from two weeks before surgery, for the duration of hospital stay, and for 30 days after discharge, an expected average of 8 weeks.
Secondary outcomes:
measure: Postoperative outcome
timeFrame: The outcomes will be assessed for the duration of hospital stay and for 30 days after discharge
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
state: MI
Study officials:
affiliation: Università Vita-Salute San Raffaele
name: Marco Braga, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balzano G, Zerbi A, Braga M, Rocchetti S, Beneduce AA, Di Carlo V. Fast-track recovery programme after pancreatico- duodenectomy reduces delayed gastric emptying. Br J Surg. 2008 Nov;95(11):1387-93. doi: 10.1002/bjs.6324.
citation: Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schafer M, Parks RW, Fearon KC, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CH; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. World J Surg. 2013 Feb;37(2):240-58. doi: 10.1007/s00268-012-1771-1. No abstract available.
Clinical trial NCT00572806: Initiation of Insulin Aspart in Type 2 Diabetes
Official title: Evaluation of the Initiation of Insulin Treatment Using Insulin Aspart on Blood Glucose Profile in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-12-13
Enrollment: 6
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate if using insulin aspart as start therapy will improve the efficacy on daytime blood glucose cycle profile in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes for at least 3 years
* HbA1c greater than 8.0%
* Body Mass Index (BMI) below 40.0 kg/m2
* Inadequate treatment with diet and OADs
* Never received treatment with insulin

Exclusion Criteria:

* Type 1 diabetes
* Known or suspected allergy to investigational product

Primary outcomes:
measure: Blood glucose value
timeFrame: at 5 pm in a daytime blood glucose cycle profile
Secondary outcomes:
measure: Evaluation of 24-hour blood glucose cycle
measure: HbA1c
measure: Hypoglycaemic episodes
Other outcomes:
Locations:
city: MONTPELLIER cedex 5
country: France
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06451406: Hyaluronic Acid Injection in the Glans Penis Versus Selective Serotonin Reuptake Inhibitors for Lifelong Premature
Official title: Hyaluronic Acid Injection in the Glans Penis Versus Selective Serotonin Reuptake Inhibitors for Lifelong Premature: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Selective Serotonin Reuptake Inhibitor
Hyaluronic Acid
Glans Penis
Lifelong Premature
Lead sponsor: New Valley University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the effectiveness and safety of selective serotonin reuptake inhibitors (dapoxetine) and hyaluronic acid gel injection in the glans penis for lifelong premature.

Detailed description: Over the past 30 years, the common knowledge of Premature ejaculation (PE) has advanced strikingly. PE is a very common and upsetting sexual male dysfunction. It is disturbing for both partners affecting their sexual experience, reducing their quality of life up to sexual abstinence, causing lack of self-confidence and even depression. It has a prevalence of a variable range, yet it is thought that one third of all males might complain of PE at a certain point throughout their lives and the incidence is rising.

Many treatment modalities have been currently used for PE varying from behavioral therapy to medical treatment and finally surgical therapy. Methods of behavioral therapy are: Squeeze technique and Start/stop technique. Pharmacological therapies include: nonselective and selective SSRIs, topical therapy with anesthetics, PDE5 inhibitors, opioid agonists and others. As for surgical modalities for PE there are several techniques including: glans augmentation, frenectomy, dorsal selective neurectomy, pulsed radiofrequency neuromodulation, removal of foreskin remnants and varicocelectomy.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old.
* Males.
* Suffering from lifelong premature ejaculation not responding to the behavioral therapy.

Exclusion Criteria:

* Erectile dysfunction.
* Prostatitis.
* Acquired premature ejaculation.
* Addiction.
* Psychiatric disorders (e.g., schizophrenia, bipolar disorder, and other psychoses).
* Historical use of ejaculatory medication within the previous three months.

Primary outcomes:
measure: Intravaginal ejaculation latency time (IELT)
timeFrame: 6 months following treatment
Secondary outcomes:
measure: International index of erectile function-5 (IIEF-5)
timeFrame: 6 months following treatment
measure: Index of premature ejaculation (IPE)
timeFrame: 6 months following treatment
measure: Patient satisfaction
timeFrame: 6 months following treatment
measure: Incidence of side effects
timeFrame: 6 months following treatment
Other outcomes:
Locations:
city: New Valley
country: Egypt
facility: New Valley University
Study officials:
References:
Clinical trial NCT01104506: Elaboration of a Pre-surgery Mapping Protocol of Primary Motor Cortex, Prior to an Implementation of a Stimulation of Primary Motor Cortex for Patients With Deafferentiation of Brachial Plexus Pain
Official title: Elaboration of a Pre-surgery Mapping Protocol of Primary Motor Cortex, Prior to an Implementation of a Stimulation of Primary Motor Cortex for Patients With Deafferentiation of Brachial Plexus Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Painful Avulsion of Brachial Plexus
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In the context of an insufficiency of clinical results for cortical stimulation in treatment of brachial plexus post-avulsion pains, one of the possibility for failure is the bad pre-surgery mapping of the area to stimulated bu the usual methods (PEM et fMRI). This purpose of this study is to realise a precise mapping of the primary motor cortex post brachial plexus avulsion.

The principal endpoints is to identify and test the reliability of a muscular marker for which the cortical representation is localized immediately next to the superior member area. Several muscles of cephalic, cervical and chest area will be investigate.

The methods used will be mono-shock transcranial magnetic stimulation (mTMS) and functional MRI.

Concerning mTMS, several methods will be tested: best position on the scalp, realisation of outputs maps with extreme points average method, with mass center method.

Concerning fMRI studies, the above paradigms will be checked: imaginary movements of hand, blow up and down abdomen, eyes winking.

Statistical tests will confirm the best muscle candidate and will permit to evaluate the reliability of the method.


Eligibility criteria: Inclusion Criteria:

* For all groups: informed consent, social insurance
* For group 1 "painful BPA": consulting to the Nantes'UH for pain of BPA, EVA≥4, neurological deficiency partial or total
* For group 2 "painless BPA": EVA\<4, neurological deficiency partial or total, matching with group 1 on the neurological deficiency
* For group 3 "Healthy": matching with group 1 on age ±10 years

Exclusion Criteria:

* No informed consent
* Medical history of epilepsy
* Pregnant women
* Contra-indication to MRI

Primary outcomes:
measure: Identify the 2 muscles (lateral and medial) lining the representation of superior member according to Penfield's homunculus.
Secondary outcomes:
measure: Evaluation of primary outcome depending on cortical center
measure: Evaluation of primary outcome depending on the center of cortical area
measure: Evaluation of primary outcome depending on cortical surface
measure: Pain intensity
measure: Ghost sensations intensity
measure: Amplitude of PEM
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes UH
Study officials:
References: