louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02399748: A Long-term Study for the Outcome of Pompe Disease
Official title: A Long-term Study for the Outcome of Pompe Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pompe Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of Pompe disease who under enzyme replacement therapy

Brief summary: Prospectively follow patients with Pompe disease underwent enzyme replacement therapy.


Eligibility criteria: Inclusion Criteria:

Confirm diagnosis with Pompe disease, is or is preparing receiving enzyme replacement therapy

Exclusion Criteria:

No

Primary outcomes:
measure: all cause morbidities
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yin-Hsiu Chien
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04767048: Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy
Official title: Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy: a Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cancer of Head and Neck
Adenopathy
Keywords: mucosectomy
tonsil
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: We are proposing a randomized phase II study to assess the benefit of bilateral robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the assessment of prevalent cervical lymphadenopathy


Eligibility criteria: Inclusion Criteria:

* Patient with a prevalent head and neck lymphadenopathy with positive or non-contributory fine needle aspiration, or having had an adenectomy revealing a metastasis of squamous cell carcinoma, a PET examination, an injected cervico-thoracic CT and an ENT work-up (nasofibroscopy) not finding a primary tumor
* Performance Status \< 2
* Patient aged 18 or over
* Patient affiliated with social security system
* Informed consent signed

Exclusion Criteria:

* History of squamous cell carcinoma of the VADS or skin of the face.
* History of cervico-facial radiotherapy
* Primary tumor discovering during pan-endoscopy
* Inexposable patient lead not to possible mucosectomy
* Uncontrollable hemostasis disorders (contraindication to tonsillectomy and basic bilateral mucosectomy of language)
* Distant metastases
* Lymphadenopathy inoperable
* Patient with a contraindication to radiotherapy
* Pregnant or breastfeeding woman
* Women of childbearing potential without effective contraception
* Patient under guardianship or unable to give informed consent
* Patient unable to undergo the trial follow-up for geographic, social or psychopathological reasons

Primary outcomes:
measure: Detection of primary cancer
timeFrame: At surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: CHU CAEN
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Chru Lille
city: Rouen
country: France
facility: CHU Rouen
Study officials:
References:
Clinical trial NCT01036048: A Meta-analysis of Drug Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Disease
Official title: Drug Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Disease: Insights From a Meta-analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Saphenous Vein Graft Disease
Keywords: saphenous vein graft
stent
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2009-12-21
Enrollment: 5806
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with CABG disease

Brief summary: A meta-analysis to compare outcomes of drug eluting stents (DES) versus bare metal stent (BMS) in saphenous vein graft (SVG) disease.

Detailed description: To compare outcomes (death, myocardial infarction, target vessel revascularization) of drug eluting stent versus bare metal stent in saphenous vein graft disease.

Eligibility criteria: Inclusion Criteria:

* CABG disease
* randomized studies
* not randomized studies

Exclusion Criteria:

* studies reporting composite and not single endpoints, duplicate reporting

Primary outcomes:
measure: death
timeFrame: years depending from studies retrieved
Secondary outcomes:
measure: myocardial infarction
timeFrame: years depending from study retrieved
measure: target vessel revascularization
timeFrame: years depending from study retrieved
Other outcomes:
Locations:
Study officials:
affiliation: OSPEDALE MAGGIORE NOVARA
name: ALESSANDRO LUPI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CATHOLIC UNIVERSITY OF SACRED HEART
name: ELIANO NAVARESE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lupi A, Navarese EP, Lazzero M, Sansa M, De Servi S, Serra A, Bongo AS, Buffon A. Drug-eluting stents vs. bare metal stents in saphenous vein graft disease. Insights from a meta-analysis of 7,090 patients. Circ J. 2011;75(2):280-9. doi: 10.1253/circj.cj-10-0186. Epub 2010 Dec 14.
Clinical trial NCT05379348: Davos Alzheimer's Collaborative Study: Sequential Administration of Digital Testing To Screen For Cognitive Impairment Followed By Blood Based Biomarkers To Assist With Timely Detection And Accurate Diagnosis Of Alzheimer's Disease
Official title: Davos Alzheimer's Collaborative Study: Sequential Administration of Digital Testing To Screen For Cognitive Impairment Followed By Blood Based Biomarkers To Assist With Timely Detection And Accurate Diagnosis Of Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Alzheimer Disease
Lead sponsor: AdventHealth Translational Research Institute
Sponsor class: OTHER
Collaborators: name: Davos Alzheimer's Collaborative
First posted: 2022-05-18
Enrollment: 1423
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy male and females ages \>65 years old.

Brief summary: The purpose of this study is to investigate how we can detect Alzheimer's disease early by using an online memory test and a simple blood test. These new methods for early diagnosis could allow people to begin treatment sooner, with the potential to improve the lives of millions of people.


Eligibility criteria: Inclusion Criteria

Subjects must meet the following criteria for entry into the study:

1. Male or female \> 65 years of age at the time of consent;
2. Understand and voluntarily sign an informed consent form;

Inclusion criteria is assessed at both e-consent (assessed by participant's self-reporting of age and understanding) and in-person consent at TRI (assessed by clinical research coordinators in TRI).

Exclusion Criteria

Subjects who meet any of the following criteria will not be eligible for entry into the study:

1. Subjects who are unable to hear and see well enough to complete the assessments;
2. Prior diagnosis of dementia or Alzheimer's disease documented in their medical record and/or as diagnosed by a physician; Exclusion criteria is assessed by by participant's self-reporting of understanding and not having a prior diagnosis of dementia at the time of e-consentand visit 1 at TRI. ).

Primary outcomes:
measure: Quantify the proportion of individuals at least 65 years old with cognitive impairment
timeFrame: Less than 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Translational Research Institute
state: Florida
Study officials:
affiliation: Study PI
name: Steven Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01446848: Oral Iron Supplementation in Pulmonary Hypertension
Official title: Oral Iron Supplementation in Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Keywords: iron deficiency
pulmonary hypertension
iron supplements
ferrous sulfate
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency.

Detailed description: Pulmonary arterial hypertension (PAH) is a chronic disease associated with upregulation of hypoxia inducible-factor-1alpha (HIF-1alpha) and functional iron deficiency. The investigators are proposing a prospective, single-arm, open-label intervention to determine whether oral iron supplementation in patients with pulmonary arterial hypertension reduces markers of HIF activation and improve clinical parameters of disease. After the baseline visit, patients will be given ferrous sulfate tablets to take orally for 3 months. Outcome data will be collected at the baseline visit and at the end of the 3-month study period.

Eligibility criteria: Inclusion Criteria:

* age 21 and older
* diagnosis of idiopathic pulmonary arterial hypertension
* iron deficiency (transferrin saturation \<20% and serum ferritin \< 100 ug/l)

Exclusion Criteria:

* active infection, malignancy, or bleeding
* hemochromatosis
* chronic inflammatory or autoimmune disease
* currently taking experimental/study medications, erythropoietin, iron supplementation, or immunosuppressants
* allergy to iron

Primary outcomes:
measure: Change in Zinc protoporphyrin from baseline
timeFrame: 3 months
measure: Change in serum ferritin from baseline
timeFrame: 3 months
Secondary outcomes:
measure: Change in serum erythropoietin from baseline
timeFrame: 3 months
measure: Change in transferrin saturation from baseline
timeFrame: 3 months
measure: Change in %CD34+/133+ cells from baseline
timeFrame: 3 months
measure: Change in pulmonary arterial pressure from baseline
timeFrame: 3 months
measure: Change in six minute walk distance from baseline
timeFrame: 3 months
measure: NYHA/WHO classification
timeFrame: 3 months
measure: Side effects of iron supplementation
timeFrame: 3 months
measure: Deaths and hospitalizations greater than 24 hours
timeFrame: 3 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Samar Farha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05805748: Serious Game Therapy in Neglect Patients
Official title: Development of a Therapeutic Serious Game in the Rehabilitation of Stroke Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Unilateral Spatial Neglect
Keywords: rehabilitation
new technology
unilateral spatial neglect
Lead sponsor: Hopitaux de Saint-Maurice
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each patient was assigned to a group who received 2 rehabilitations for 3 weeks, 1) both serious game training and a conventional rehabilitation first and then conventional rehabilitation alone (group 1, G1), or 2) a conventional rehabilitation first and then both serious game training and a conventional rehabilitation (group 2, G2).
Primary purpose: TREATMENT

Brief summary: The growing field of new technologies offers new perspectives for neurorehabilitation. Serious games are a promising solution in the rehabilitation of cognitive impairments, and they may be useful in the rehabilitation of unilateral spatial neglect. Investigators developed a rehabilitation program for visual exploration training with a serious game and investigated its efficiency. Twelve patients with unilateral spatial neglect after a right hemispheric stroke were recruited. Six patients assigned to a group received both serious game training and conventional rehabilitation, and after only conventional rehabilitation; and six patients assigned to another group received first conventional rehabilitation and then serious game training and conventional rehabilitation. The investigators compared the two groups after rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Unilateral spatial neglect syndrome
* Right cerebral lesion

Exclusion Criteria:

* Epilepsia
* General mental deterioration
* Psychiatric disorder
* No prior history of neurological disease

Primary outcomes:
measure: Behavioral Inattention Test (BIT)
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Catherine Bergego Scale (CBS)
timeFrame: up to 6 weeks
measure: Functional Independence Measure (FIM)
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Saint-Maurice
country: France
facility: Hôpitaux de Saint Maurice
Study officials:
References:
Clinical trial NCT00149448: Effectiveness of the TB Contact Priority Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2005-09-08
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The broad purpose of this project, proposed by investigators at the University of Alabama at Birmingham and the State of Alabama Department of Public Health, is to use a behaviorally focused education that has been proven effective to enhance the accuracy and efficiency of the contact investigation process. The behaviorally focused intervention will focus on enabling public health workers to understand and implement a recently published model of TB transmission.

Detailed description: BACKGROUND:

Investigation of contacts of patients with active pulmonary tuberculosis (TB) is an important epidemiological tool in TB control. Unfortunately, due to budgetary and resource constraints, many health departments struggle to fulfill their responsibility of TB control through contact investigation.

DESIGN NARRATIVE:

Primary outcome The primary outcome of this project is to examine the clinical effectiveness of the TB transmission model. This will be done by examining the sensitivity and specificity of the model when used in a field application.

Key secondary outcomes Evaluation of the efficiency of contact investigation (two outcomes: 1) weekly average time to tuberculin skin test placement for high risk contacts, 2) weekly average time to the close of the contact investigation.) Qualitative assessment of individuals who are incorrectly predicted by the model to have a negative tuberculin skin test

Eligibility criteria: B field workers for the Alabama Department of Public Health.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03600948: BIOFLOW-SV All Comers Registry
Official title: BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the SiroLimus Eluting Orsiro Stent Within Daily Clinical Practice in Small Vessels
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: de Novo
Symptomatic Ischemic Heart Disease
Restenoses, Coronary
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 261
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: This registry will include subjects requiring a treatment of coronary artery disease with an Orsiro DES.

Brief summary: Assessment of the clinical safety and performance of the Orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm.

Detailed description: Prospective, single-arm, multi-center, all-comers registry with clinical follow-up visits at the hospital or by phone at 6 and 12 months post-procedure.

A minimum of 1000 patients will be enrolled in approximately 15 sites in Brazil, including at least 415 patients with reference vessel diameter ≤2.75 mm as assessed by online QCA.

Eligibility criteria: Inclusion Criteria:

* Subjects ≥18 years of Age
* Subject must sign a Patient Informed Consent (PIC)
* Subject must agree to undergo all required follow-up visits, either at the hospital or by phone.
* Subject with coronary artery disease requiring treatment with Orsiro Sirolimus eluting stent system

Exclusion Criteria:

* Pregnant and/or breast feeding females at the time of enrolment
* Known allergies to Acetylsalicylic Acid (ASA), clopidogrel, ticlopidine, heparin or any other anticoagulant /antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs, or the stent materials that cannot be adequately pre-medicated
* Currently participating in another study that has not yet reached the primary endpoint.

Primary outcomes:
measure: Target Lesion Failure for the small vessel group
timeFrame: 12 months
Secondary outcomes:
measure: TLF for the overall cohort
timeFrame: at 12 months
measure: Clinically driven Target Lesion Revascularization (TLR)
timeFrame: at 6 and 12 months
measure: Clinically driven Target Vessel Revascularization (TVR)
timeFrame: at 6 and 12 months
measure: Definite and probable stent thrombosis
timeFrame: at 6 and 12 months
measure: Procedure success
timeFrame: 12 months
measure: Device success
timeFrame: 12 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Moinhos de Vento Hospital
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base
Study officials:
affiliation: Moinhos de Vento Hospital
name: Marco Weinstain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06048848: FNB in ACL Recon Under GA
Official title: Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Anterior Cruciate Reconstruction Under General Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Femoral Nerve Block
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for anterior cruciate ligament reconstruction under general anesthesia.

Detailed description: This study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and MRI or ultrasonography, and were diagnosed with anterior cruciate ligament rupture from september 2023 to august 2028. The 100 patients will be assigned to Group I (with femoral nerve block) or Group II (without femoral nerve block) under double-blinded randomization. The randomization will be performed by an independent nurse using a computerized random sequence generator. The operators who participated in the procedure will be blinded to the participant's information. Both group will undergo general anesthesia for arthroscopic anterior cruciate ligament reconstruction. After anesthesia, sono-guided femoral nerve block will be performed. The injection for group1 is 20 mL ropivacaine and for groupII is 20 mL 0.9% saline. A visual analog scale (VAS) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. VAS scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. Injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.

Eligibility criteria: Inclusion Criteria:

* individuals who are scheduled to undergo arthroscopic anterior cruciate ligament reconstruction surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate.

Exclusion Criteria:

* who require simultaneous surgery for concomitant cartilage injury, medial meniscus tear, and lateral collateral ligament tear.
* who have previously undergone surgical treatment within the knee joint.
* who have declined to participate in the research.
* where medical, surgical, or anesthetic complications occurred during surgery.
* other cases deemed necessary by the researchers.

Primary outcomes:
measure: postoperative pain after 24hours
timeFrame: 24hours
Secondary outcomes:
measure: postoperative pain after 1, 3, 6, 12, 18, 48 hours
timeFrame: 1, 3, 6, 12, 18, 48 hours
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Gangwon-do
Study officials:
References: