louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00763932: Extension Study of Long-term Safety and Efficacy of Myozyme in Patients With Pompe Disease Who Were Previously Enrolled in Genzyme Sponsored Enzyme Replacement Therapy (ERT) Studies
Official title: A Multicenter, Open-Label Extension Study of the Long-Term Safety and Efficacy of Recombinant Human Acid α-Glucosidase (rhGAA) in Patients With Pompe Disease (Glycogen Storage Disease Type II) Who Were Previously Enrolled in Genzyme-Sponsored Enzyme Replacement Therapy Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pompe Disease Infantile-Onset
Glycogen Storage Disease Type II
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-01
Enrollment: 7
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: This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in patients with infantile-onset Pompe disease who were previously treated with rhGAA derived from the Synpac cell line


Eligibility criteria: Inclusion Criteria:

* The patient was enrolled in Protocol AGLU-008-01, AGLU-009-02, or AGLU01502
* The patient's legal guardian(s) provided written informed consent prior to any study related procedures being performed
* The patient and his/her guardian(s) were able to comply with the clinical protocol, which required extensive clinical evaluations for an extended period of time.

Exclusion Criteria:

* Patients were excluded from this study if they did not meet the specific inclusion criteria, or if the patient experienced any unmanageable AE in Protocol AGLU-008-01, AGLU-009-02, or AGLU01502 (as determined and agreed upon by the Principal Investigator and Genzyme Corporation), due to Synpac rhGAA therapy, that would preclude continuing therapy

Primary outcomes:
measure: The objective of this extension study was to monitor the long-term safety and efficacy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Children's Hospital of Oakland
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange Country
state: California
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New Brunswick
country: United States
facility: Institute for Genetic Medicine, Saint Peter's University Hospital
state: New Jersey
city: New York
country: United States
facility: New York University [NYU] School of Medicine
state: New York
city: Lyon
country: France
facility: Pediatrique Hospital Debrousse
city: Orleans
country: France
facility: Hôpital Porte Madeleine
city: Johannesburg
country: South Africa
facility: The Morningside Clinic
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04500132: To Evaluate Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia
Official title: Phase 2, Multi-center, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Enzychem Lifesciences Corporation
Sponsor class: INDUSTRY
First posted: 2020-08-05
Enrollment: 63
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prevention of COVID-19 infection to severe pneumonea or ARDS


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Male or female age 19 years or older
* Pathologically confirmed diagnosis of COVID-19 Infection to Pneumonia

Exclusion Criteria:

* Pathologically confirmed diagnosis of bacterial pneumonia or viral pneumonia
* Pregnant or nursing at the time of signing informed consent
* Known sensitivity to any study medication
* Unwilling or unable to complete study diary
* Any other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the protocol

Primary outcomes:
measure: Rate of transition to ARDS
timeFrame: 14 days after starting IP administration
Secondary outcomes:
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
Study officials:
affiliation: Chungbuk National University Hospital
name: Hyewon Jeong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06353737: Looking for Asymptomatic Mpox in a Population at High Risk
Official title: Looking for Asymptomatic Mpox in a Population at High Risk
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mpox (Monkeypox)
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 450
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants need to have been enrolled in an existing randomized clinical trial (NCT04762134)

Brief summary: Mpox is caused by a virus that can be spread through touching the affected skin of someone who has the infection, touching sheets or clothes that has been used by someone with the infection, or breathing in particles of virus from someone who has the infection. Mpox infection can cause skin and flu-like symptoms, but can also cause very few symptoms, or no symptoms at all. While the number of participants with mpox symptoms can be tracked, little is known about how many people have mpox, but experience few or no symptoms at all. To do this, a Canadian sample of gay, bisexual and other men who have sex with men (GBMSM) who are participating in a randomized controlled trial will be screened for mpox symptoms. Screening will include questions about whether they may be experiencing any mpox symptoms, history of past diagnosis of mpox, sexual history, and vaccination history and awareness. Swabs will be taken to test for the presence of mpox virus, and a blood sample will be taken to test for antibodies. Approximately 450 individuals will be recruited. The results will be descriptive in nature.


Eligibility criteria: Inclusion criteria:

- Participants need to have been enrolled in an existing randomized clinical trial (NCT04762134)

Exclusion criteria:

- None

Primary outcomes:
measure: Asymptomatic prevalence
timeFrame: 2 weeks
Secondary outcomes:
measure: Symptomatic prevalence
timeFrame: 2 weeks
measure: Mpox seropositivity
timeFrame: 2 weeks
measure: Characteristics
timeFrame: 2 weeks
measure: Characteristics of seropositivity
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Unity Health Toronto
state: Ontario
Study officials:
References:
Clinical trial NCT03284632: e-Cigarette - DNA Adducts
Official title: e-Cigarettes: Formaldehyde DNA Adducts, Oxidative Damage, and Potential Toxicity and Carcinogenesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Cigarette Smoking
Electronic Cigarettes
Keywords: Tobacco
E-Cigarettes
Toxicants
Formaldehyde DNA Adducts
Oxidative Damage
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2017-09-15
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited locally within reasonable distance from the University of Minnesota.

Brief summary: This study will examine the level of toxicity of e-cigarette use compared to smokers and nonsmokers including inflammation markers, toxicant and carcinogen exposure. Additionally, the study will look at the effect of varying voltage levels for e-cigarette users.

Detailed description: In this observational study, e-cigarette users, smokers, and non-users of e-cigarette or tobacco products (up to 134 per group) will be recruited from the Minneapolis-St. Paul area. This research will be conducted at the Tobacco Research Programs at the University of Minnesota. Subjects are screened for eligibility over the phone. If eligible after the phone screen, participants will be invited to attend orientation screening visit in the clinic where consent will be obtained and subjects will complete forms about their tobacco and e-cigarette use and medical history. Subjects who eligible will be asked to return for six visits over the course of six months.

At these appointments, subjects will provide biological specimen samples (buccal cells, urine and blood). Saliva will be collected before and after a smoking or vaping session. Non-users will only have 1 saliva collection.

Subjects will be asked for information pertaining to and e-cigarette and tobacco use and overall health.

Eligibility criteria: Inclusion Criteria:

* Good physical health with no unstable medical conditions; Able to provide written informed consent; Stable and good mental health;

Meet criteria for 1 of three groups:

1. Regular smokers confirmed by CO;
2. E-cigarette users (exclusive e-cigarette use for 3 months); Non-Tobacco Users
3. Non-smokers

Exclusion Criteria:

* Unstable medical condition Not willing to attend visits

Primary outcomes:
measure: DNA Adducts
timeFrame: 6 months
Secondary outcomes:
measure: Urinary 8-iso-PGF-2α
timeFrame: 6 months
measure: Urinary PGEM
timeFrame: 6 months
measure: C-reactive protein
timeFrame: 6 months
measure: TNE
timeFrame: 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Stephen Hecht, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04919837: The Efficacy of an Artificial Intelligence Platform to Adapt Visual Aids for Patients With Low Vision: a Randomised Controlled Trial
Official title: The Efficacy of an Artificial Intelligence Platform to Adapt Visual Aids for Patients With Low Vision: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ophthalmology
Low Vision Aids
Artificial Intelligence
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: 2nd Affilliated Hospital of Fujian Medical University
First posted: 2021-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 105
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: According to the WHO's definition of visual impairment, as of 2018, there were approximately 1.3 billion people with visual impairment in the world, and only 10% of countries can provide assisting services for the rehabilitation of visual impairment. Although China is one of the countries that can provide rehabilitation services for patients with visual impairment, due to restrictions on the number of professionals in various regions, uneven diagnosis and treatment, and regional differences in economic conditions, not all visually impaired patients can get the rehabilitation of assisting device fitting.

Traditional statistical methods were not enough to solve the problem of intelligent fitting of assisting devices. At present, there are almost no intelligent fitting models of assisting devices in the world. Therefore, in order to allow more low-vision patients to receive accurate and rapid rehabilitation services, we conducted a cross-sectional study on the assisting devices fitting for low-vision patients in Fujian Province, China in the past five years, and at the same time constructed a machine learning model to intelligently predict the adaptation result of the basic assisting devices for low vision patients.


Eligibility criteria: Inclusion Criteria:

* Low vision Aged 3 to 105

Exclusion Criteria:

* Severe systemic diseases Failure to sign informed consent or unwilling to participate

Primary outcomes:
measure: The proportion of giving up assisting devices
timeFrame: Baseline
Secondary outcomes:
measure: Time cost of using assisting devices of patients
timeFrame: Baseline
Other outcomes:
Locations:
city: Quanzhou
country: China
facility: 2nd Affilliated Hospital of Jujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT05009537: Optical Genome Mapping in Hematological Malignancies
Official title: Optical Genome Mapping in Hematological Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: MDS
ALL
Other Hematologic Malignant Neoplasms
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected hemopathies

Brief summary: Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer


Eligibility criteria: Inclusion Criteria:

* Minor/Major Patients
* Patients with suspected hemopathies for whom we receive a sample for diagnosis in the chromosomal genetics laboratory or for whom a diagnosis of hemopathy has already been made.
* No objection made or consent given

Exclusion Criteria:

* Patients under judicial protection (guardianship, curatorship, ...),
* Refusal to participate

Primary outcomes:
measure: Establish the diagnostic potential of optical genome mapping in patients with suspected hematologic cancer
timeFrame: 2021-2026
Secondary outcomes:
measure: identification of new chromosomal abnormalities of clinical relevance.
timeFrame: 2021-2026
measure: identification of new chromosomal anomalies involved in oncogenic pathways
timeFrame: 2021-2026
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Morlaix
country: France
facility: CH Morlaix, service d'hémato clinique
city: Quimper
country: France
facility: CHIC, service d'hémato clinique
city: Saint-Brieuc
country: France
facility: CH St Brieuc, service d'hémato clinique
Study officials:
References:
Clinical trial NCT04087837: The Effectiveness of Using Bougie or Cooled Nasogastric Tube to Facilitate Nasotracheal Intubation
Official title: Using Bougie or Cooled Nasogastric Tube to Facilitate Nasotracheal Tube Advancement Into Trachea Under Video-laryngoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Complication
Keywords: bougie, nasotracheal tube
Endotracheal Tube intubation General Anesthesia (ETGA)
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: bougie or nasogastric tube
Primary purpose: PREVENTION

Brief summary: either uses a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx and advanced into the trachea

Detailed description: In oro-maxillo-facial surgery, it is a common practice for patients receiving general anesthesia with nasotracheal intubation to widen the surgical field and to ease undergoing surgery. However, a nasotracheal tube blindly passing through the nasal cavity may easily result in nasal cavity and oropharynx damages. In addition, the advancement of the tube from oropharynx into trachea may assist by either using magic forceps or cuff inflation technique.

The aim of the study is to investigate either use a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx, and advanced into the trachea.

Patients were randomized into three groups by using either bougie or nasogastric tube to facilitate nasotracheal tube sliding through into trachea from assigned nostril and compared with the control group with a conventional technique.

Hemodynamic changes in each time interval, each time taken of tube going through the nasal cavity, tube advanced from oropharynx into trachea were recorded. The incidence of using Magill Forceps to accurately place tube tip into trachea, intubation related side effects and complications were recorded at postoperative time stages.

Eligibility criteria: Inclusion Criteria:

* Age:20-65 years
* Undergoing oro-maxillofacial surgery
* Opening mouth \> 3 cm
* Denied any systemic disease.
* American Society of Anesthesiologists (ASA) class:I-III

Exclusion Criteria:

* Difficult airway assessed (limited mouth opening, limited neck motion, and thyromental distance \< 6cm)
* Previous head and neck surgery history
* Upper abnormal airway diagnosed
* Easily epistaxis
* Both sides nasal cavities obstruction

Primary outcomes:
measure: success rate of tube advancement and successful first tube attempt
timeFrame: 10 minutes
measure: time taken in tube advancement
timeFrame: 10 minutes
Secondary outcomes:
measure: post-intubation induced hoarseness and sore throat
timeFrame: 2 days
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References:
Clinical trial NCT01056237: Long-Term Study of Multi-target Therapy as Maintenance Treatment for Lupus Nephritis
Official title: Research Institute of Nephrology, Jinling Hospital,
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lupus Nephritis
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An multi-site, randomized, prospective study to compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment versus CTX- Aza therapy.

Detailed description: Azathioprine (AZA) has been used for maintenance therapy of lupus nephritis for many years. We compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment vs CTX-Aza.

Eligibility criteria: Inclusion Criteria:

1. Patients who signed written informed consent form
2. SLE patient, aged between 18-65 years, female or male;
3. Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy
4. All patients had received induction therapy for 6 months with multi-therapy (FK506 + MMF) or intravenous CTX pulses.
5. Patients were recruited when received partial remission or complete remission after 6 months induction therapy.

Complete remission: proteinuria \<0.4 g/24h, negative urine sediment, serum albumin \>35 g/L, elevated scr \<0.3mg/dl, no extra-renal complications; Partial remission: proteinuria \<1.0 g/24h, urine RBC \<50X104/ml without casts, serum albumin \> 30 g/L, elevated Scr \<0.3mg/dl,no extra-renal complications.

Exclusion Criteria:

1. Patients who didn't sign written informed consent form or could not obey the protocol.
2. Patients who didn't received the CR or PR criterion.
3. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
4. WBC \<3000/mm3 in peripheral blood .
5. Patients with central nervous system symptoms. -

Primary outcomes:
measure: To compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology, Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Research Institute of Nephrology, Jinling Hospital
name: zhihong Liu, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03874637: FemPulse Therapy First-in-Human Experience
Official title: Evaluation of a Wearable Electrical Incontinence Device in Subjects: A Non-significant Risk Clinical Evaluation of FemPulse Therapy in Women With OAB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Bladder, Overactive
Keywords: Overactive Bladder
Women
Neuromodulation
Bioelectronic Medicine
Non-significant Risk
Lead sponsor: FemPulse Corporation
Sponsor class: INDUSTRY
First posted: 2019-03-14
Enrollment: 15
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will be treated at 2 different device settings (one of which is Off) in random sequence during two 6-hour periods at least one week apart.
Primary purpose: OTHER

Brief summary: The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

Detailed description: The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves in the lower abdomen that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Eligibility criteria: Inclusion Criteria:

* Females ≥21 yrs with Overactive Bladder

Exclusion Criteria:

* Is or was recently pregnant
* Has a metal pelvic implant or any electrically active implanted medical device
* Has a urinary tract or vaginal infection
* Had a previous hysterectomy, pelvic radiation or pelvic cancer
* Has significant pelvic organ prolapse
* Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days
* Has a significant heart condition or a history of vasovagal reaction or low blood pressure

Primary outcomes:
measure: Adverse Events
timeFrame: 3 days in total
measure: Placeability and comfort of the device
timeFrame: 3 days in total
Secondary outcomes:
measure: Frequency of urinary voids
timeFrame: 3 days in total
measure: Intervals between urinary voids
timeFrame: 3 days in total
measure: Urge urinary incontinence (UUI)
timeFrame: 3 days in total
Other outcomes:
Locations:
city: Woodbury
country: United States
facility: Minnesota Urology
state: Minnesota
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
References: