louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01525732: Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Esophageal Motility Disorders
Official title: Prospective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achalasia
Hypertensive LES
Keywords: Achalasia, Hypertensive LES
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.


Eligibility criteria: Inclusion Criteria:

* All patients with age ranged 18 to 80 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.

Exclusion Criteria:

* Patients will be excluded from this study with the followings -

  1. Pregnancy
  2. Informed consent not available
  3. Previous history of esophagectomy or mediastinal surgery
  4. Previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection
  5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow

Primary outcomes:
measure: Dysphagia score before and after P.O.E.M.
timeFrame: From 1st day after POEM to within 2 weeks after POEM
Secondary outcomes:
measure: Eckardt score before and after P.O.E.M.
timeFrame: Before and 1 month after POEM
measure: Post-operative pain
timeFrame: From Day 1 to until 2 weeks after POEM
measure: Operative time
timeFrame: Up to 24 hours
measure: Hospital stay
timeFrame: From day of admission till up to 30 days
measure: Perioperative complication
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
References:
citation: Chiu PW, Wu JC, Teoh AY, Chan Y, Wong SK, Liu SY, Yung MY, Lam CC, Sung JJ, Chan FK, Lau JY, Ng EK. Peroral endoscopic myotomy for treatment of achalasia: from bench to bedside (with video). Gastrointest Endosc. 2013 Jan;77(1):29-38. doi: 10.1016/j.gie.2012.08.018. Epub 2012 Oct 6.
Clinical trial NCT00220532: Folate and Protection Against Cervical Cancer
Official title: A Randomised Placebo-Controlled Trial to Evaluate Interactions Between Riboflavin and Folate Intake and Genotype in Reducing Risk of Cervical Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Cervical Cancer
Keywords: Randomised placebo controlled intervention trial
Folic acid
Riboflavin
cervical cancer
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: World Cancer Research Fund International
First posted: 2005-09-22
Enrollment: 180
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomised double-blind placebo-controlled trial to see whether giving a low dose of the vitamins folic acid and riboflavin is beneficial to women who have very low grade abnormalities of the cervical cells.

Detailed description: The overall aim of the study is to evaluate interactions between intakes of folic acid and riboflavin with a common polymorphism relevant to folate metabolism, in determining the risk of cervical cancer in women who carry high risk human papillomavirus.

We will test the following hypotheses:

Supplements of riboflavin and folic acid will increase the rate of regression of low grade cervical intra epithelial neoplasia (CIN1).

Effects of supplemental folic acid and riboflavin on CIN1 regression are modulated by a common polymorphism in the MTHFRC677T gene.

We will recruit women with biopsy-proven CIN1 and carrying high risk HPV infection, and randomise to a 12month intervention of 1.2mg folic acid and 5mg riboflavin or placebo. The primary outcome will be regression of biopsy-proven CIN1, and secondary outcomes will include measures of DNA stability.

Eligibility criteria: Inclusion Criteria:

* biopsy-diagnosed CIN1 infection with oncogenic HPV

Exclusion Criteria:

Any other stage of cervical abnormality pregnant or planning a pregnancy diabetic taking B vitamin supplements taking anti-epileptic treatment taking methotrexate bleeding after intercourse abnormal GI function infection with chlamydia, HIV or other agent

Primary outcomes:
measure: Rate of regression of CIN1 to normal over a 12 month intervention
Secondary outcomes:
measure: DNA strand breakage, in cervical cells
measure: DNA hypomethylation, in cervical cells
measure: Cervical cell folic acid
measure: HPV persistence over 12 months of intervention
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: University of Sheffield
state: South Yorkshire
Study officials:
affiliation: Human Nutrition Unit, University of Sheffield
name: Hilary J Powers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05596032: Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2
Official title: Prospective Field Study to Validate the Diagnostic Performance of the IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2 on abioSCOPE®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
COVID-19 Pandemic
Lead sponsor: Abionic SA
Sponsor class: INDUSTRY
First posted: 2022-10-27
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes unselected participants\*, symptomatic, asymptomatic having had close contact with positive patients, and asymptomatic with no known exposure to SARS-CoV-2.

Brief summary: The purpose of the study is to conduct a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for antigenic determination of SARS-CoV-2 virus on the abioSCOPE® instrument.

The objective of the clinical study is to demonstrate that the IVD CAPSULE COVID-19-NP test:

1. shows sensitivity:

   * ≥ 80% when testing unselected symptomatic participants within the first seven days of symptom onset or asymptomatic participants when diagnosis is confirmed by RT-PCR; Or
   * ≥ 90% for subjects with Ct ≤ 25.
2. show ≥ 98% specificity.


Eligibility criteria: Inclusion Criteria:

* provide valid informed consent before taking the tests;
* in the case of symptomatic patients, be tested within the first seven days after the onset of symptoms.
* Male or female, aged equal to or older than 18 years of age.

Exclusion Criteria:

* Symptomatic participants who take the test after seven days after the onset of symptoms are excluded from the study

Primary outcomes:
measure: Diagnostic performance of the IVD CAPSULE COVID-19-NP antigenic test
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: A.O Mauriziano di Torino
Study officials:
References:
Clinical trial NCT02344732: Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy
Official title: Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Diseases
Keywords: epithelium, cornea, diabetes, vitrectomy, oxygen
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To compare the corneal epithelial defect healing time between diabetic patients receiving and not receiving supplementary oxygen after vitrectomy.
2. To determine whether factors such as age, duration of diabetes, duration of surgery and level of glycemic control have any influence on corneal epithelial wound healing time in diabetic patients receiving and not receiving supplementary oxygen post-vitrectomy.

Detailed description: This study aims to determine whether systemic oxygen therapy delivered through face mask would have beneficial effects on the healing of corneal epithelial wound in post-vitrectomy diabetic patients. It will be a prospective, randomised interventional clinical study conducted on diabetic patients indicated for vitrectomy. Rationale of this study is to see if systemic oxygen delivered via face mask will hasten the resolution of corneal epithelial defects, which may either be iatrogenic (surgically-induced intra-operatively to enable clearer visualisation for the surgeon) or spontaneous (due to corneal epithelial fragility which is commoner in diabetics)

Eligibility criteria: Inclusion Criteria:

* diabetic patients aged 18 years and above planned for pars plana vitrectomy that required intra-operative corneal epithelial debridement to allow better surgical visualisation of the fundus were recruited within the study duration

Exclusion Criteria:

* pre-existing ocular surface or corneal disease, recent eye surgery within one month from the vitrectomy, glaucoma and if the patients have any contraindications to oxygen therapy (e.g. chronic obstructive pulmonary disease).

Primary outcomes:
measure: Mean corneal epithelial wound healing time (in days)
timeFrame: 1 to 7 days
Secondary outcomes:
measure: Age of subject as a factor influencing wound healing time
timeFrame: 1-7 days
measure: Glycemic control of subject (measured by glycated hemoglobin, HbA1c)
timeFrame: 1-7 days
measure: Duration of surgery and its influence on wound healing time
timeFrame: 1-7 days
measure: Duration of diabetes mellitus (measured in years) and its influence on wound healing time
timeFrame: 1-7 days
Other outcomes:
Locations:
Study officials:
affiliation: Universiti Sains Malaysia
name: Wee-Min Teh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05252832: Superficial Cervical Plexus Block for IJCL Pain Management
Official title: Evaluation of the Efficacy of the Superficial Cervical Plexus Block in Reducing Pain Associated With Internal Jugular Central Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Superficial Cervical Plexus Block
Pain
Keywords: Superficial Cervical Plexus Block
Pain Management
Lead sponsor: Cleveland Clinic Akron General
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participant blinded block randomization of the control local infitrate (Arm 1) and the experimental SCPB (Arm 2).
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized trial evaluating the effect of SCPB on reported patient pain following IJCL placement as compared to local infiltrate.

Detailed description: The goal of this study is to determine if SCPBs provide more pain control than local infiltrate of anesthetic for internal jugular venous cannulation. The investigators hypothesis that patients who receive the SCPB will have a lower VAS rating on average than those who receive local infiltration following internal jugular venous cannulation. To test this, the investigators will be approaching eligible patients for inclusion in a research study. If the patients consent, the patients will be randomly assigned the standard of care treatment or the SCPB. The investigators will then ask the patients to rate pain following insertion of the central line. The investigators will also evaluate different aspects of the patient's hospital course to evaluate their outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients who are 18 years and older, and;
* Present to the Akron General Emergency Department (Main) between March 1, 2021 and December 1, 2022, and;
* Require IJVC as a part of their clinical care.

Exclusion Criteria:

* Patients who are intubated; or
* Patients who undergo CPR; or
* Patients who have an allergy to lidocaine or bupivacaine; or
* Patients who have a contraindication to receiving a superficial cervical plexus block such as cellulitis over Erb's point or the internal jugular vein, abnormal anatomy, or prior surgery to the area.

Primary outcomes:
measure: Visual Analog Scale Rating
timeFrame: 30 minutes post central line placement
Secondary outcomes:
measure: Complications
timeFrame: Duration of emergency department and inpatient encounter, typically no more than 7 days.
Other outcomes:
Locations:
city: Akron
country: United States
facility: Cleveland Clinic Akron General
state: Ohio
Study officials:
affiliation: Cleveland Clinic Akron General
name: Robert Stenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03116932: Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part A
Official title: Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part A
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV/AIDS
Keywords: HIV prevention, high risk MSM, PrEP
Lead sponsor: Puerto Rico Community Network for Clinical Research on AIDS
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2017-04-17
Enrollment: 225
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 225 high risk men who have sex with men, HIV- subjects, 21 years or older , will be enrolled in Part A

Brief summary: The target population for this project will be men-who-have-sex-with-men (MSM) at high risk of HIV acquisition

Detailed description: 225 high risk MSM will be interviewed to understand the knowledge and acceptability of pre-exposure prophylaxis (PrEP) in this population in Puerto Rico. A 187 item questionnaire will administered which will evaluate socio-demographic information, sexual conducts, PrEP knowledge and PrEP acceptability.

Eligibility criteria: INCLUSION CRITERIA;

Study subjects who meet the following inclusion criteria will be considered for enrollment for Part A:

1. age 21 years or older
2. understand and sign the informed consent form and willing to participate in the study
3. male or transgender female
4. has one of the following risk factors:

   * a high risk MSM as defined by:
   * having unprotected sexual intercourse with at least two male partners in the past 6 months, or
   * diagnosed with an STI in the past 6 months.

PART A - EXCLUSION CRITERIA:

Subjects with any of the following will not be considered for enrollment in Part A:

1. Age younger than 21 years old
2. Unable or unwilling to provide an informed consent
3. Female gender at birth
4. Do not meet the high risk criteria

Primary outcomes:
measure: PrEP acceptability using a PrEP knowledge and acceptability questionnaire.
timeFrame: One visit
measure: PrEP knowledge using a PrEP knowledge and acceptability questionnaire.
timeFrame: One visit
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA)
Study officials:
affiliation: 787-753-9443
name: Vivian Tamayo-Agrait, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05319132: Evaluate DF-003 in ex Vivo Assays Using Peripheral Blood Mononuclear Cell From Subjects With ROSAH Syndrome
Official title: A Phase 0 Study to Evaluate DF-003 in ex Vivo Assays Using Peripheral Blood Mononuclear Cells (PBMC) From Subjects With Retinal Dystrophy, Optic Nerve Edema, Splenomegaly, Anhidrosis and Headache (ROSAH) Syndrome.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Unrecognized Condition
Keywords: ROSAH Syndrome.
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 4
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 study concerns adult subjects with ROSAH syndrome

Brief summary: Alpha-1 kinase (ALPK1) has been reported as a potential causative gene for ROSAH Syndrome.

Genetic variants including T237M have been found in ROSAH Syndrome patients. Our in-house study has found that T237M mutation leads to hyperactivity of ALPK1, which may be the cause of the inflammatory syndromes found in ROSAH Syndrome patients. We hypothesize that T237M mutation ALPK1 cause ROSAH Syndrome and an ALPK1 inhibitor can be a potential therapy for treating this disease. To test our hypothesis, we designed an experiment in which ex vivo peripheral blood mononuclear cells (PBMCs) from ROSAH Syndrome patients will be exposed to a potent ALPK1 inhibitor (DF-003) or placebo. We expect to see downregulation of activated inflammatory genes, chemokine/cytokines and acute phase proteins in the ROSAH Syndrome patient samples that are exposed DF-003.


Eligibility criteria: Inclusion Criteria:

* Male or female aged over 18
* Patient with ROSAH syndrome with the confirm T237M mutation

Exclusion Criteria:

* person under legal protection or under protectives measures
* person unable to express consent
* person in emergency situation (vital or not)
* person infected by Human Immunodeficiency Virus and/or Hepatitis B Virus and/or Hepatitis C Virus

Primary outcomes:
measure: Cytokine release assays
timeFrame: At day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Nord Croix Rousse
state: Rhône-Alpes
city: Angers
country: France
facility: service de Genetique - Institut de Biologie Santé PBH-IBS
city: Paris
country: France
facility: Hôpital de la Pitié Salpétrière
city: Reims
country: France
facility: Service D'ophtalmologie
city: Rennes
country: France
facility: Service de médecine interne et immunologie clinique
Study officials:
affiliation: Service de medecine interne - Hôpital de la Croix Rousse
name: YVAN JAMILLOUX
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01974232: A Retrospective Chart Review of Thirty Three Children Who Have Received Clinical Treatment With Either Romiplostim or Eltrombopag From 2009-2013
Official title: A Retrospective Chart Review of Thirty Three Children Who Have Received Clinical Treatment With Either Romiplostim or Eltrombopag From 2009-2013
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Thrombocytopenia
Keywords: Immune Thrombocytopenia (ITP), Thrombopoietin (TPO) agents, children, romiplostim and eltrombopag
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Orange County
First posted: 2013-11-01
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients eligible for this study included both males and females ≤ 21 years old (actual range 19 months - 19 years) with persistent/chronic ITP lasting \>6 months and were diagnosed according to the clinical practice guidelines from the American Society of Hematology.

Brief summary: This is a retrospective analysis of children (≤21years old) who received clinical treatment with either Romiplostim or Eltrombopag at 2 medical centers from 2009-2013. The children included in this study were from Weill Medical College of Cornell University, New York, New York and Children's Hospital Orange County, Orange, California


Eligibility criteria: Inclusion Criteria:

1. All patients in this study had received prior treatments before the start of TPO treatment including corticosteroids, IVIG, IV anti-D, and/or Rituximab.

Exclusion Criteria:

1. Children who do not have ITP

Primary outcomes:
measure: Platelet count greater than or = to 50,000
timeFrame: on two consecutive weeks
Secondary outcomes:
measure: An increase in platelets greater than or = to 20,000 over baseline.
timeFrame: On two consecutive weeks
Other outcomes:
measure: Percentage of weeks with platelet counts greater than or = to 50,000 independent of rescue therapy.
timeFrame: For Rescue therapy is defined as receiving Intravenous Immunoglobulin (IVIG) increased dose steroids or platelet transfusions . When given this resulted in exclusion of platelet counts for 2 full weeks after indication of rescue therapy ..
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: James B Bussel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04955132: Impact of E-learning on Parental Confidence in Managing Food Allergy
Official title: Impact of E-learning on Parental Confidence in Managing Food Allergy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Allergy in Children
Food Allergy in Infants
Keywords: Food allergy
Milk
Egg
Wheat
Children
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Education and dietary support are integral in managing food allergy in children. The study aim is to analyze the impact of E-learning on parental confidence in managing their child's food allergy.

Detailed description: Food allergy is a common childhood morbidity, that has increased in prevalence over the last few decades. Education and dietary support is integral in managing food allergy in children; however it is labor intensive and requires financial resources, which places an economic burden on the healthcare system. The study aim is analyze the impact of E-learning on parental confidence in managing their child's food allergy.

Eligibility criteria: Inclusion Criteria:

* Legal caregivers of a child that is allergic (confirmed by an allergist) to at least one of the main food allergens (cow's milk, egg or wheat) and is following an elimination diet to at least one of these allergens.
* Internet access available.

Exclusion Criteria:

* Participant non proficient in Lithuanian.

Primary outcomes:
measure: Parental confidence in managing food allergy
timeFrame: After 1 month.
Secondary outcomes:
measure: Parental satisfaction
timeFrame: After 1 month.
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Clinics
Study officials:
affiliation: Vilnius University Faculty of Medicine
name: Ieva Adomaite
role: PRINCIPAL_INVESTIGATOR
References: