louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06310252: Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-up
Official title: A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Intrastromal Implantation of the Transform Corneal Allograft (TCA) for Providing Near Vision in Presbyopic Subjects - Long Term Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presbyopia
Lead sponsor: Allotex, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 71
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A maximum of 101 eyes of qualified and consented subjects will undergo long term follow-up after instrastromal implantation of the TCA for presbyopia.

Brief summary: The objective of this clinical study is to evaluate the long term safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for providing near vision in presbyopic subjects.

A maximum of 101 eyes of qualified and consented subjects will undergo long term follow-up after instrastromal implantation of the TCA for presbyopia.


Eligibility criteria: Inclusion Criteria:

* Provide informed consent, have signed the written informed consent form, and been given a copy.
* Subjects must be willing and able to return for one scheduled follow-up examinations.
* Subjects must have undergone implantation with the TCA under study protocol PRO-010 between April 24, 2019 and October 31, 2019.

Exclusion Criteria:

• There are no known exclusion criteria.

Primary outcomes:
measure: An exploratory data collection project with no primary safety or effectiveness endpoints.
timeFrame: 4 years or more after TCA implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Zlín
country: Czechia
facility: Gemini - Oční klinika Zlín
city: Dublin
country: Ireland
facility: Wellington Eye Clinic
city: Istanbul
country: Turkey
facility: Medipol University
city: East Grinstead
country: United Kingdom
facility: Centre For Sight
city: London
country: United Kingdom
facility: Eye Clinic London
city: London
country: United Kingdom
facility: Centre For Sight
city: Oxshott
country: United Kingdom
facility: Centre For Sight
Study officials:
References:
Clinical trial NCT05326152: Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts
Official title: Intralesional or Intramuscular Hepatitis B Vaccine Versus Intralesional Saline in the Treatment of Multiple Common Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-04-13
Enrollment: 75
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of the effectiveness of intralesional and intramuscular hepatitis B vaccine in treatment of multiple common warts.

Detailed description: Recently, intralesional immunotherapy by different antigens, including Candida antigen and purified protein derivative PPD has been proved effective in the treatment of different types of warts. Hepatitis B vaccine is one of the DNA vaccines that are regarded as being potentially safer, relatively cheap and easy to produce with no special storage requirements because they are extremely stable and allow for potential simultaneous immunization against multiple antigens or pathogens via co-expression of multiple epitopes on single plasmid. Hepatitis B vaccine could be a promising immunotherapeutic vaccine in the field of intralesional immunotherapy of warts. Moreover, the efficacy of intramuscular injection of hepatitis B vaccine would be assessed and compared to its intralesional injection.

Eligibility criteria: Inclusion Criteria:

• Adult patients of both sexes with multiple (\> 3 warts) common warts of various sites, sizes and duration, with or without distant warts after taking informed consent from all patients

Exclusion Criteria:

* Pregnancy or lactation.
* Serious systemic or anaphylactic reaction to a prior dose of the vaccine or to any of its components.
* Allergic skin disorders such as generalized eczema and urticaria.
* Moderate or severe acute illness with or without fever.
* Previous wart therapy within 1 month prior to the study.

Primary outcomes:
measure: Efficacy of intralesional versus intramuscular hepatitis B vaccine in the treatment of multiple common warts
timeFrame: up to 3 months after last injection
measure: Immediate adverse effects
timeFrame: up to 20 minutes after intralesional or intramuscular injection of vaccine
Secondary outcomes:
measure: Efficacy of intralesional versus intramuscular hepatitis B vaccine in distant wart response
timeFrame: up to 3 months
measure: Late adverse effects
timeFrame: up to 6 months follow-up period
measure: Recurrence
timeFrame: for 6 months-follow-up
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
state: Sharkia
Study officials:
References:
Clinical trial NCT06210152: Does Radial Extracorporeal Shockwave Therapy Applied to the Achilles Tendon Influence Ankle Functionality?
Official title: Influence of Radial Extracorporeal Shockwave Therapy on Achilles Tendon on Ankle Functionality
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Healthy
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The recruitment of participants for the study is planned to take place in Han-nam-dong and at Sahmyook University in Seoul, Republic of Korea. Potential participants selected through recruitment documents will be enrolled upon meeting the eligibility criteria. After providing a comprehensive explanation of the study, those who voluntarily agree to participate will be recruited.

Brief summary: Radial Extracorporeal Shockwave Therapy has been shown to restore shortened muscles and normalize fibrotic tissues in muscles or fascia. Shockwave therapy can soften fibrotic tissues and alleviate pain. While there are various methods to relax muscles and fascia, radial extracorporeal shockwave therapy can achieve good results in a short treatment time. Although there is research on the pain-related effects of radial extracorporeal shockwave therapy for conditions such as plantar fasciitis and knee osteoarthritis, there is a lack of literature on its functional effects. Therefore, this study aims to investigate the improvement of ankle functionality through the application of radial extracorporeal shockwave therapy.


Eligibility criteria: Inclusion Criteria:

* Individuals who have ankle-related pain scores of 0 to 2 on the Numeric Pain Rating Scale (NPRS).
* Individuals with no functional impairment in the ankle.

Exclusion Criteria:

* Individuals who have undergone surgical procedures such as ankle joint arthrodesis.
* Individuals showing signs of functional impairment in ankle functionality.
* Individuals with ankle-related pain rated above 3 on the NPRS.
* Individuals with acute ankle fractures.

Primary outcomes:
measure: Jump height
timeFrame: Immediate change from baseline after intervention
measure: flying time
timeFrame: Immediate change from baseline after intervention
measure: contact time
timeFrame: Immediate change from baseline after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sahmyook University
Study officials:
References:
Clinical trial NCT05336552: Social Anxiety Disorder in Medical Students in Sohag University
Official title: Social Anxiety Disorder in Medical Students in Sohag University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Anxiety Disorder
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted among medical undergraduate students in Sohag University.

Brief summary: The study will be done in Sohag University to assess the prevalence and associated factors of Social Anxiety Disorder among undergraduate medical students .

Detailed description: Social anxiety disorder (SAD) is highly prevalent and it's the most common anxiety disorder among all types of anxiety disorders and the third most common psychiatric condition after major depression and alcohol dependence.

Social anxiety disorder (SAD) is characterized by persistent fear/anxiety about one or more social or performance situations in social settings.

SAD had a negative impact on learning ability, educational achievement, professional achievement, quality of life and social relationship \& may lead to substance abuse and depressive disorders.

Eligibility criteria: Inclusion Criteria:

* Medical undergraduate students who are still studying for Bachelor of Medicine and Bachelor of Surgery ( M.B.B.Ch ) .

Exclusion Criteria:

* students who will refuse to participate in this study .

Primary outcomes:
measure: Social Phobia Inventory ( SPIN ) questionnaire
timeFrame: It will be measured after completion of the study , approximately in May 2023.
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
affiliation: osama_morad@med.sohag.edu.eg
name: Osama Morad, Lecturer
role: STUDY_DIRECTOR
affiliation: Dr_taher65@yahoo.com
name: Taher Abd-Elraheem-Sayed, Assistant professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05203952: Purify Antigen-specific B Cells From Patients With Rheumatoid Arthritis
Official title: New Therapeutic Approach to Cure Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: B cells
Rheumatoid arthritis
ACPA
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are selected based on the presence of high serum ACPA levels (medical record analyses). Patients treated with Rituximab resulting in total B cell depletion are not selected for this study

Brief summary: Rheumatoid arthritis (RA) is an autoimmune disease characterized by the presence of autoantibodies directed against citrullinated proteins, called ACPAs. These antibodies are very specific to RA, and the severity of the disease is closely correlated with the level of these ACPAs, even though they appear much earlier than the clinical signs. Current treatments by biotherapies are effective but only treat the inflammatory symptoms of the disease or, on the contrary, induce a global immunosuppression with a depletion of all B lymphocytes.

Contrary to the current approaches, the CURE RA project proposes a double innovative character:

* The project aims at specifically destroying B lymphocytes expressing / or secreting ACPAs for a more specific approach to RA, without inducing immunosuppression.
* The new therapeutic molecule is entirely original and has no equivalent at present, it uses the target antigens of autoantibodies, the citrullinated peptides, as tools to destroy the pathogenic B cells that express/produce these autoantibodies.


Eligibility criteria: Inclusion criteria:

- Antibodies anti-CCP + (ACPA +) \> 250 IU/mL

Exclusion criteria:

* Current or past Rituximab (Mabthera) treatment past (\< 9 months)
* Abatacept treatment

Primary outcomes:
measure: Establishment of B cell line
timeFrame: 1 day
Secondary outcomes:
measure: Validation of new therapeutic molecules
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Yves-Marie PERS, MCU-PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01287052: Nitrous Oxide for Acute Migraine Pain in the Emergency Room (ED)
Official title: Nitrous Oxide for Acute Pediatric Migraine Pain Management in the Emergency Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Pain
Keywords: Migraine
Pediatric
Adolescent
Nitrous Oxide
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2011-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: BACKGROUND Migraine headaches account for 8-18% of all headaches seen in pediatric emergency rooms. Standard treatment includes IV pain medications, anti-emetics, and IV fluids. Nitrous oxide has analgesic properties similar to those of opioids and is easy to administer. It has been shown in two small studies to be effective in treating migraine headaches.

RESEARCH QUESTION Does nitrous oxide act as a safe, less invasive, and effective treatment of acute migraine headaches in children and adolescents presenting to an Emergency Department?

DESIGN This is a prospective non-randomized self-controlled study. Repeated measures will be taken to examine change in pain scores before and after nitrous oxide treatment.

METHODS Each participant will be given nitrous oxide until he/she reports a pain score of zero or up to fifteen minutes. Study subjects will be asked to rate their pain on a scale of 0-10 before the treatment and after the treatment at multiple time-points.


Eligibility criteria: Inclusion Criteria:

* During the study enrollment period, eligible subjects will be English-speaking children and adolescents
* Between the ages of 8 - 18 years (inclusive)
* With history of migraine present for at least one year
* With previous migraine headaches conforming to ICHD-II diagnostic criteria
* Able to give assent according to institutional guidelines, and
* Have parental consent to participate.

Exclusion Criteria:

* Any patients will be excluded if he/she
* Has had any neurosurgical interventions
* Has underlying seizure disorders
* Presents with a headache of a different quality than their other migraines
* Has contraindications to nitrous oxide
* Unable to complete the pain assessment
* Does not have a dependable contact number for the follow-up call

Primary outcomes:
measure: Decrease in the acute migraine pain in children and adolescents presenting to an Emergency Department
timeFrame: within 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
Study officials:
affiliation: Children's Hospitals and Clinics of Minnesota
name: Andrea Hoogerland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00166452: A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1
Official title: Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidamide in the Treatment of Complex Regional Pain Syndrome Type1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Complex Regional Pain Syndrome, Type 1
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Elgene Chemical
First posted: 2005-09-14
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).


Eligibility criteria: Inclusion Criteria:

1. Age \> or = to 18 years
2. Signed consent form
3. A diagnosis of CRPS type I for at least one-year duration with unilateral involvement of a distal limb
4. CRPS pain intensity score at least 4 on an 11-point PI-NRS
5. Measurable sural, median sensory, median motor and peroneal motor nerve conductions
6. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting the study drug. They must agree to use adequate contraceptive methods not including steroid-based contraceptives. They must also agree to have pregnancy tests every 4 weeks while on the study drug.

Primary outcomes:
measure: RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Keith A Bengtson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04524052: To Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of DWRX2003 Against COVID-19
Official title: Phase I Study to Evaluate the Safety, Tolerability, Pharmacodynamics (PD) and Pharmacokinetics (PK) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-08-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of Niclosamide (DWRX2003) following escalating doses of DWRX2003 administered as an intramuscular injection in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Normal healthy human adult male and female volunteers between 18-45 years (both ages inclusive) of age.
2. Volunteers who agree to give written informed consent and are willing to participate in the study.
3. Volunteer having bodyweight minimum of 50 kg.
4. Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive).

Exclusion Criteria:

1. Known allergic to Niclosamide or any component of the formulation and to any other related drug.
2. History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
3. Female volunteers who are nursing mothers/lactating women or are found positive in beta hCG test.
4. History/ current use of Alcohol or drug abuse.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: follow-up 48 days after dosing
Secondary outcomes:
measure: pharmacokinetic changes of niclosamide from baseline in each dose group: Cmax
timeFrame: follow-up 48 days after dosing
measure: pharmacokinetic changes of niclosamide from baseline in each dose group: Tmax
timeFrame: follow-up 48 days after dosing
measure: pharmcodynamic analysis of niclosamide from baseline in each dose group and time point: CRP
timeFrame: on Day 3, 7, 10 and 14
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03621852: Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®)
Official title: Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®) in Tumors of the Pancreas, Submucosal Tumors and Lymph Node Disease of the Upper GI Tract
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tumors of the Pancreas
Submucosal Tumor of Gastrointestinal Tract (Disorder)
Lymph Node Disease
Keywords: Endosonography
fine needle biopsy
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing EUS FNB with solid pancreatic tumors, submucosal tumors or lymph node disease of the upper gastrointestinal tract.

Brief summary: The present study investigates the efficacy of a new Endoultrasound guided fine needle biopsy (EUS-FNB) device (AquireTM Boston Scientific= AQUIRE®) for obtaining histological tissue cylinders in the diagnosis of solid pancreatic tumors, submucosal tumors of the upper gastrointestinal tract (esophagus, stomach, duodenum) and lymph node disease..

Detailed description: The AquireTM FNB device uses a triple point tip that is designed to maximize tissue capture and minimize fragmentation.

The efficiency of the 22 Gauge needle is evaluated in a prospective single arm study. The material obtained will be collected for formalin fixation and analyzed by a pathologist blinded for the type of needle device.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Indication for EUS FNB with solid pancreatic tumors, submucosal tumors or lymph node disease of the upper gastrointestinal tract will be included

Exclusion Criteria:

* Cystic pancreatic tumors
* Contraindication for EUS FNB
* Lesion of interest cannot be reached endosonographically

Primary outcomes:
measure: tissue yield
timeFrame: 12 month after FNB
Secondary outcomes:
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Universitätskliniken Gießen und Marburg, Standort Marburg
state: Hessen
Study officials:
References:
Clinical trial NCT04838652: Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma
Official title: Phase II Trial of Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Classical Hodgkin Lymphoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to develop an effective and well-tolerated regimen for treatment of r/r cHL by introducing the anti-PD-1 antibody pembrolizumab and adding it to well-established chemotherapy regimens (ICE, DHAP). Synergistic effects of conventional agents with checkpoint inhibition may facilitate a highly effective therapy with limited toxicity, which might eventually substitute the very toxic high-dose chemotherapy (HDCT).


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed first relapse of cHL or primary refractory cHL

Exclusion Criteria:

* Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma

Primary outcomes:
measure: Complete Metabolic Response Rate (CMR)
timeFrame: after completion of P+chemotherapy, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: 1st Department of Medicine, Cologne University Hospital
Study officials:
affiliation: 1st Department of Medicine, Cologne Universit Hospital
name: Andreas Engert, Prof.
role: PRINCIPAL_INVESTIGATOR
References: