louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03487315: Major Allergen in Wheat Anaphylaxis in Thai Population
Official title: Major Allergen in Wheat Anaphylaxis in Thai Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wheat Allergy
Anaphylaxis Food
Anaphylaxis Exercise
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 36
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: * To study Major allergen in Wheat anaphylaxis in Thai population
* To study and compare demographic data between group of wheat anaphylaxis

Detailed description: Wheat is one of the most common causes in food-induced anaphylaxis and food dependent, exercised induced anaphylaxis. Gold standard for diagnose food allergy is double blind placebo control food challenge, but it is a high risk procedure. The accuracy of skin prick test and specific IgE assay showed unsatisfactory results. It might be explained by these tests may not detect all of the major allergens in wheat allergic patients. Previous studies showed that the major allergens of wheat dependent, exercised induced anaphylaxis are omega5 gliadin, followed by high molecular weight glutenin. For IgE-mediated wheat allergy, the major allergens varied among studies, including omega5 gliadin, glutenin, alpha/beta/gamma gliadin, and the water-soluble part of wheat allergens. There is no study to direct compare the major allergen between patients who have low wheat specific IgE and very high wheat specific IgE. Also, there is no data about the major allergens of wheat anaphylaxis in Thai population.

Eligibility criteria: Inclusion Criteria:

* Wheat anaphylaxis patient aged 1-60 years, who received treatment at division of allergy, department of Pediatrics and Medicine, Siriraj Hospital from 2001 to 2016

Exclusion Criteria:

* Loss follow up
* No consent form
* Celiac disease, Autoimmune disease was diagnosed

Primary outcomes:
measure: Major allergen sensitized by Thai Patients with Wheat anaphylaxis
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Punchama Pacharn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsson N, Sjolander S, Baar A, Berthold M, Pahr S, Vrtala S, Valenta R, Morita E, Hedlin G, Borres MP, Nilsson C. Wheat allergy in children evaluated with challenge and IgE antibodies to wheat components. Pediatr Allergy Immunol. 2015 Mar;26(2):119-25. doi: 10.1111/pai.12334.
Clinical trial NCT01094015: Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice
Official title: Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice: a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: hysteroscopy
local anaesthetic
pain relief
gynecological pathology
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2010-03-26
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysteroscopy diagnostic practice.


Eligibility criteria: Inclusion Criteria:

* patients that he must perform a diagnostic hysteroscopy
* acceptance to participate in the study signed informed consent

Exclusion Criteria prerandomization:

* hypersensitivity or allergy to anesthetics
* refusal of the patient
* patients under age 18 and pregnant

Exclusion Criteria postrandomization:

* dropout
* unbearable pain that involves other analgesic measures
* allergic reactions to topical anesthetics

Primary outcomes:
measure: pain reduction in the performance of hysteroscopy
timeFrame: after hysteroscopy and a month later
Secondary outcomes:
measure: sense of discomfort experience during the procedure
timeFrame: a month after hysteroscopy
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Baldomero Arnau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05213052: Effects of Topical Cream for Pain Relief
Official title: Document Magnitude and Timing for Pain Relief of Topical Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An open-label study design where all study participants will receive the active test product and no placebo is used.
Primary purpose: BASIC_SCIENCE

Brief summary: To perform a clinical proof-of-concept study on a novel topical formula for pain relief.

Detailed description: An open-label study where each participant will be involved in the study for 4 weeks. During the study participants will use the topical cream 1-2 times daily on the anatomical area(s) causing the most pain.

Eligibility criteria: Inclusion Criteria:

* BMI between 18.5 and 34.9 kg/m2 (inclusive)
* Chronic joint/muscle related pain for at least past 6 months
* Experiencing chronic pain in at least one specific anatomical area for more than 6 months.

Exclusion Criteria:

* Cancer during past 12 months
* Chemotherapy during past 12 months
* Currently taking prescription pain medications
* Getting regular joint injections (such as cortisone shots);
* Immunization during last month
* Participation in another clinical trial study during this trial, involving an investigational product or lifestyle change
* Regularly experiencing headaches, including migraines
* Serious active illness within past 6 months
* Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure).
* Skin allergies related to ingredients in test product.

Primary outcomes:
measure: Change in degree of pain
timeFrame: 4 weeks
Secondary outcomes:
measure: Activity level
timeFrame: 4 weeks
Other outcomes:
measure: Wellness
timeFrame: 4 weeks
Locations:
city: Klamath Falls
country: United States
facility: Gitte Jensen
state: Oregon
Study officials:
References:
Clinical trial NCT04659252: CORONADO (Circulating tumOur pROtein quaNtification cApillary blooD cOvid-19)
Official title: Circulating Tumour Protein Quantification From Capillary Blood for Patient Selfsampling and Safe Remote Monitoring of Multiple Myeloma During COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: Royal Marsden NHS Foundation Trust
First posted: 2020-12-09
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple myeloma patients attending routine phlebotomy clinic.

Brief summary: The coronavirus (COVID-19) pandemic has brought severe challenges for myeloma patients. Myeloma patients are considered ultra-high risk for COVID-19 and fall into the strictest group for shielding. When on treatment, but also during times of active surveillance, patients have to regularly and frequently leave shielding and visit the hospital for blood tests to monitor their disese. This is specifically for quantification of circulating tumour protein biomarker tests for paraprotein (PP) and/or serum free light chains (sFLCs) by specialised biochemistry units.

This research aims to evaluate the potential use of an at-home patient administered technique to sample blood. The purpose of the blood sampling technique is to monitor your disease status. We want to test if it is possible to monitor a patient's disease status using this alternative blood collection method when compared to monitoring disease status using the traditional blood collection methods (venous blood sampling).

The new VAMS method is not intended to be used interchangeably or will not replace the current method. This study is to evaluate an alternative sample type that may be used to improve the patient pathway, especially during these uncertain times.


Eligibility criteria: Inclusion Criteria:

1. A diagnosis of a B-cell dyscrasia
2. Measurable disease by serum free light chain assay
3. Signed informed consent

Exclusion Criteria:

1. Patients \<21 years of age
2. Cognitive impairment
3. Non-B Cell Dyscrasia patients

Primary outcomes:
measure: Validated FLC
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Kevin Boyd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05710952: Impact of Orthodontic Treatment on the Temporomandibular Joints (TMJ) Assessed by Modjaw
Official title: Impact of Orthodontic Treatment on the Temporomandibular Joints (TMJ) Assessed by Modjaw in Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: Temporomandibular joint
Orthodontic
Modjaw
Orthodontic braces
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to assess the correlation between orthodontic treatment and temporomandibular joint (TMJ). For that, an evaluation with a virtual articulator (Modjaw) is carried out before and after the treatment. The condylar course are compared. Furthermore, the eventual TMJ symptoms are also compared before and after.


Eligibility criteria: Inclusion Criteria:

* Major patient (≥18 years)
* First dentofacial orthopedic consultation at the dental clinic of Montpellier
* Patient requiring multi-attachment orthodontic treatment (vestibular or lingual) for a duration ≤2 years
* Signed informed consent

Exclusion Criteria:

* Syndromic patient
* Orthodontic treatment with aligners
* General joint or bone pathology
* Patients with oral hygiene incompatible with orthodontic treatment

Primary outcomes:
measure: Gap reduction between the interincisive point in mouth opening and the ordinate axis
timeFrame: Up to 24 months
Secondary outcomes:
measure: Condylar courses homogeneity
timeFrame: Up to 24 months
measure: Condylar courses symmetry
timeFrame: Up to 24 months
measure: Condylar courses straightness
timeFrame: Up to 24 months
measure: Amplitude of the condylar path
timeFrame: Up to 24 months
measure: Straightness of the condylar path
timeFrame: Up to 24 months
measure: Adverses events
timeFrame: Up to 24 months
measure: Pain assessment
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre de soins dentaires
Study officials:
References:
Clinical trial NCT03716752: Modified Connective Tissue Graft Wall With Wing Technique for Posterior Teeth
Official title: Modified Connective Tissue Graft Wall With Wing Technique for Posterior Teeth in Treating One Wall Vertical Bone Defects With Class III Gingival Recession: A 12 Months Follow up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recession
Keywords: connective tissue wall technique
modified connective tissue wall technique with a wing
recession defects in posterior teeth
recession defects with infrabony defects
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: October University for Modern Sciences and Arts
First posted: 2018-10-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators reported here the application of usage modified connective tissue graft wall technique for posterior teeth. The treatment outcomes suggested the efficacy of the used technique in treating recession defects accompanied by infrabony defects in molars.

Detailed description: Gingival recession is defined as the apical migration of the gingival margin leaving the root surface denuded. Treatment of Class III and IV defects and achievement good of results seems to be quite difficult due to the advanced loss of the soft and hard tissues supporting the affected teeth. Furthermore, partial to total loss of the interproximal papilla is one of the main challenges that contribute for achieving higher levels of esthetics especially in anterior zone. In such a case, conventional techniques of root coverage results usually in poor prognosis.

Eligibility criteria: Inclusion Criteria:

* recession defects in posterior teeth
* vertical infrabony defects in relation to the same recession defect

Exclusion Criteria:

* smokers
* suystemic diseases
* pregnency and lactating mothers

Primary outcomes:
measure: recession defect dimensions
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Octobar University of Modern Sciences and Arts
Study officials:
References:
Clinical trial NCT00604552: AneuRx Post Market Study in the Treatment of AAA
Official title: AneuRx Post Market Surveillance Registry
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abdominal Aneurysm
Keywords: Abdominal Aneurysm
Endovascular Aortic Repair (EVAR)
Endovascular Stent Graft
Endograft
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2008-01-30
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. Abdominal aortic aneurysm (AAA) is a life-threatening lesion that has been treated in recent year via endovascular repair.

The purpose of this study is to monitor the long term performance of the AneuRx Stent Graft Systems.


Eligibility criteria: Inclusion Criteria:

* Patients implanted with an AneuRx Stent Graft per Instructions for Use
* Patients must provide written informed consent and agree to be accessible for follow-up at the study center.

Primary outcomes:
measure: Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion
timeFrame: 5 year
Secondary outcomes:
measure: Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events
timeFrame: 5 years
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Royal Oak
country: United States
state: Michigan
city: Morristown
country: United States
state: New Jersey
city: Asheville
country: United States
state: North Carolina
city: Chapel Hill
country: United States
state: North Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Memphis
country: United States
state: Tennessee
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Medtronic
name: Medtronic Cardiovascular
role: STUDY_CHAIR
References:
Clinical trial NCT04225052: Clinical Trial to Evaluate the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers
Official title: A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Pharmacokinetics
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
Collaborators: name: Chonbuk National University Hospital
First posted: 2020-01-13
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single dose, crossover clinical trial to evaluate the safety and pharmacokinetics of YHP1903 in healthy volunteers

Detailed description: 32 healthy subjects wil be randomized one of 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP1903" by cross-over design on day1, 8.

Subjects in group 2 will be administered "YHP1903" and "comparator" by cross-over design on day1, 8.

Eligibility criteria: Inclusion Criteria:

1. Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
2. Acceptable medical history, physical examination, laboratory tests and EKG, during screening
3. Subjects who has signed a written informed consent voluntarily,prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug

Exclusion Criteria:

1. History of clinically significant disease
2. Sitting blood pressure meeting the following criteria at screening:

   * 140 ≤ systolic blood pressure ≤90 (mmHg)
   * 90 ≤ diastolic blood pressure ≤ 60 (mmHg)
3. Have AST(SGOT) or/and ALT(SGPT) \> 1.5 times of normal upper limit or Total bilirubin \> 2.0 mg/dl at the time of screening
4. Volunteers considered not eligible for the clinical trial by the investigator
5. Administration of other investigational products within 6 month prior to the first dosing.

Primary outcomes:
measure: AUCt
timeFrame: 0-96 hours
measure: Cmax
timeFrame: 0-96 hours
Secondary outcomes:
measure: AUCinf
timeFrame: 0-96 hours
measure: Tmax
timeFrame: 0-96 hours
measure: t1/2
timeFrame: 0-96 hours
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk national university hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Mingul Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05419752: Clinical Assessment of 3 Differant Obturation Sealers on Postoprative Pain and Swelling
Official title: Assessment of 3 Different Root Canal Obturating Sealers on Postoperative Pain and Swelling in Single Canal Necrotic Teeth With a Single Visit .a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Necrotic Pulp
Single Root Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: aim of the study will be conducted to compare the effect of MTA fill apex sealer and endo sequence bioceramic sealer in obturation on the intenisty of postoperative pain and the incidence of post operative swelling in patient with necrotic teeth .


Eligibility criteria: Inclusion Criteria:

* Patients requiring root canal treatment of single canal necrotic teeth.
* Patient from 18 to 60 years old
* Patients with Asymptomatic apical periodontitis.
* Teeth presenting with no clinical symptoms and with a periapical score from 2 to 4 according to Orstavik et al

Exclusion Criteria:

* Teeth with incompletely formed apex

  * Teeth requiring retreatment
  * Patients having complicating systemic disease such as diabetes, malignancy, pregnancy, central nervous system disorders, Cardiovascular system disorders, respiratory disorders, asthma patients, psychiatric disorders, immunocompromised patients
  * Patients taking anti-inflammatory or antibiotics
  * Patients giving history of analgesic or antibiotic intake 1 week before treatment
  * Patients below 18 years of age
* Patients above 65 years of age

  * Patients having history of peptic ulcer or gastrointestinal bleeding
  * Teeth affected with periodontal disease

Primary outcomes:
measure: Intensity of post-operative pain
timeFrame: 6 hours
measure: Intensity of post-operative pain
timeFrame: 12 hours
measure: Intensity of post-operative pain
timeFrame: 24 hours
measure: Intensity of post-operative pain
timeFrame: 48 hours
measure: Intensity of post-operative pain
timeFrame: 72 hours
Secondary outcomes:
measure: post operative swelling
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02142452: Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain
Official title: Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Weight Gain
Keywords: Pregnancy
Obesity/Overweight
postpartum
mobile health
cardiovascular disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will test the efficacy of a tailored behavioral lifestyle modification program to support cardiovascular health in postpartum women with excessive gestational weight gain. This program will include a mobile health texting component postpartum to support changes in nutrition and physical activity. The investigators will randomize women into either the control arm (usual care) or the intervention (usual care + mobile health program postpartum). The women will be recruited during their 3rd trimester once they have been identified as gaining too much weight according to the 2009 IOM guidelines during pregnancy.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman diagnosed with excessive gestational weight at 24 weeks gestation or later
* Age 18 years or older
* English-speaking, and willing and able to participate in the proposed intervention.

Exclusion Criteria:

* Inability to provide informed consent and/or an inability to speak, read, or understand English
* Primary residence is outside of the immediate catchment area of 10 miles
* Physical or mental challenges that precludes them from exercising or returning for scheduled study follow ups
* Concurrent enrollment in another behavior modification program

Primary outcomes:
measure: BMI (body mass index)
timeFrame: 4 months postpartum
Secondary outcomes:
measure: Cardiovascular health metrics
timeFrame: 4 months postpartum
measure: Change in self efficacy score based on behavioral self-efficacy scale
timeFrame: 4 months postpartum
measure: Cardiovascular health metrics
timeFrame: 4 months postpartum
measure: Cardiovascular health metric
timeFrame: 4 months postpartum
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Sandra A Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References: