louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00889460: Safety and Tolerability Study of rBet v1 SLIT Tablets
Official title: Phase I Study to re-Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Multi Dose Regimens to Subjects Sensitised to Birch Pollen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Birch Pollen-Related Rhinoconjunctivitis
Rhinitis, Allergic, Seasonal
Keywords: rBet v 1
Birch pollen allergy
Sublingual Immunotherapy
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2009-04-29
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.


Eligibility criteria: Inclusion Criteria:

* written consent
* Male or female subject from 18 to 60 years old and in general good health
* For woman of child bearing potential:
* Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
* Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) \>0.70 kU/L at screening.
* FEV1 at least of 80% of predicted values at screening.
* Subject accepting to comply fully with the protocol.

Exclusion Criteria:

* Past or current disease which as judged by the Investigator, may affect the outcome of this study.
* History of life-threatening asthma,
* Asthma requiring daily treatment (whatever the pharmaceutical class).
* Pregnant or lactating woman.
* Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.
* Subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) or who plan to start desensitisation treatment during this study.
* Symptoms during the treatment phase due to a sensitivity to a second allergen.
* Subjects treated with ongoing immunotherapy with another allergen

Primary outcomes:
measure: Local tolerability
timeFrame: Assessed every day over 2 weeks
measure: Global safety
timeFrame: Assessed every day over 2 weeks
Secondary outcomes:
measure: Immunological markers (IgE and IgG4)
timeFrame: Between selection and follow-up visit (up to 18 weeks)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National University Hospital - Allergy Unit 4222
Study officials:
affiliation: National University Hospital - Copenhagen - DENMARK
name: Hans-Jorgen MALLING, Pr. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: L. Winther, L.K. Poulsen, B. Robin, M. Mélac, H. Malling Safety and Tolerability of Recombinant Bet v 1 (rBet v 1) Tablets in Sublingual Immunotherapy (SLIT) The Journal of Allergy and Clinical Immunology February 2009 (Vol. 123, Issue 2, Page S215)
Clinical trial NCT01595360: Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction
Official title: A Phase 1, Randomized, Open, Controlled, Comparative Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tooth Extraction
Keywords: TT-173
Topical Hemostatics
Hemostasis
Lead sponsor: Thrombotargets Europe S.L
Sponsor class: INDUSTRY
First posted: 2012-05-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in healthy volunteers after tooth extraction.

Detailed description: As the TT-113 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety, tolerability and efficacy of TT-113 in healthy volunteers after tooth extraction.

Eligibility criteria: Inclusion Criteria:

* Subjects to be undertaken for the simple extraction of at least one tooth (incisor, canine, premolar, molar different of third molar) that cause bloody wound, located in the upper or inferior maxillary area of the mouth either
* Subjects who are able and willing to provide written and signed informed consent
* All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits. Negative pregnancy test result in the screening visit.

Exclusion Criteria:

* Subjects with personal and family history that could affect correct hemostasis
* Subjects with any clinically-significant coagulation disorder including including deficiencies in any of coagulation factors, thrombocytopenia and vascular purpura
* Subject with hipersensivity of TT-173 of any of its components or has a known allergy.
* Subjects who are unable to adequately follow or understand the instructions and requirements of the study.
* Subjects that are not fully free to give informed consent, or any other obstacle in the opinion of investigator support the conclusion that the subject is not fully reasoned.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 4 months
Secondary outcomes:
measure: Cmax, Tmax, AUC and bioavailability
timeFrame: 48 h
measure: Determine the presence of coagulation disorders
timeFrame: 4 months
measure: Determine the immune responses to TT-173
timeFrame: 4 months
measure: Time to hemostasis until cessation of bleeding
timeFrame: time 0 until cessation of bleeding
Other outcomes:
Locations:
city: Castelldefels
country: Spain
facility: Thrombotargets Europe SL
state: Barcelona
Study officials:
References:
Clinical trial NCT02104960: Study of Skin Parameters in the PROOF Cohort
Official title: Study of Skin Parameters in the PROOF Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Aging
Keywords: Skin Surface Microscopy
Skin Aging
PROOF
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 209
Sex: ALL
Minimum age (years): 75
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PROOF cohort (NCT00759304)

Brief summary: This study aims to evaluate skin aging of an homogeneous population of 77 years old patient selected among the PROOF cohort who has been continuously investigated by cardiological examination.

Skin aging will be explored by macroscopic and microscopic evaluation. In particular, skin aging will be measured by an index of clinical aging (SCINEXA) and other complementary measures such as facial photos, standard and High Definition dermoscopy, elastography, sebumetry, in vivo and ex vivo confocal microscopy, and classical histological examinations.


Eligibility criteria: Inclusion Criteria:

* included in the PROOF cohort
* Form consent signed

Exclusion Criteria:

* Past history of surgery and / or treatment of aesthetic medicine
* neurological disorders
* insulin-dependent diabetes,
* corticosteroids or retinoids (isotretinoin, ...) \> 1 year

Primary outcomes:
measure: SCINEXA score
timeFrame: Day 1
Secondary outcomes:
measure: in vivo confocal microscopy
timeFrame: Day 1
measure: ex vivo confocal microscopy
timeFrame: Day 1
measure: histology
timeFrame: Day 1
measure: RAMAN
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Elisa CINOTTI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00576160: Improving Medication Adherence in Post-ACS Patients
Official title: Improving Med Adherence in Post-ACS Patients: Phase 1B Dose-Finding RCT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Medication Adherence
Acute Coronary Syndrome
Keywords: medication adherence
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-12-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Many post Acute Coronary Syndrome(ACS) patients do not take their medications (including aspirin) as prescribed, leading to an increase in mortality. Patients enrolled in this study will be enrolled into one of two groups. Patients in the first group will have their medication adherence measured, but will receive all other care as usual. Patients in the second group will also have their medication adherence measured, but they will receive telephone-delivered problem solving therapy (PST) in addition to their usual care. The two groups will be combined to determine the Minimally Effective Dose (MED) and the Maximally Tolerated Dose (MTD) for adherence to aspirin. The medication adherence of the PST group will improve by 20% (\<55% to \>75%).


Eligibility criteria: Inclusion Criteria:

1. Medical eligibility:

   1. Patient presenting for staged intervention with positive cardiac history OR
   2. Patient with stable CAD who received cardiac admission but does not report chest pain. OR
   3. Patient with stable CAD who has had a cardiac admission in the past.
2. Patient is non-adherent to prescribed medication.

The following exclusion criteria have been set for either safety concerns or concerns that patients will not be able to complete the protocol:

1. inability to communicate in English or Spanish
2. unwilling to be randomized or to have aspirin in a separate bottle if they use a pill box
3. unavailability for the 1 month period of the study (including being unavailable by phone and/or traveling out of the country)
4. medically unable to receive aspirin (e.g. allergy, contra-indicated, etc)
5. deemed unable to comply with the protocol (either self selected or by indicating during screening that s/he could not complete all requested tasks). This includes patients with a level of cognitive impairment indicative of dementia, and patients with current alcohol or substance abuse.
6. deemed to need immediate psychiatric assessment (e.g., must be hospitalized, or have some other psychiatric intervention conducted within 72 hours).
7. active psychosis, bipolar disorder, or any overt personality disorder

Primary outcomes:
measure: Prevalence of medication adherence
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Karina W. Davidson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02851160: Perceptions and Representations of Cancer Chemotherapy
Official title: Perceptions and Representations of Cancer Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * 30 major Patients with lung cancer requiring chemotherapy either as palliative or adjuvant as surgical treatment
* 30 significant others (relatives) major applicant lung cancer patients chemotherapy either palliation or as adjuvant to surgery
* 15 Doctors oncologists performing either chemotherapy as palliative or adjuvant as surgical treatment

Brief summary: Qualitative study on data from interviews such patients, relatives and doctors involved in the implementation of cancer care. Framework type of method using grounded theory

Detailed description: The word chemotherapy itself, because it belongs to the secular knowledge and therefore Doxa is a hard word, which stores what it is stable, common and therefore impersonal. It has the properties of a symbol, that is to say that joint several meanings, some of which are contradictory.

The objective of the research:

To determine the perceptions and representations of chemotherapy, its physical impacts, psychological and relational.

To qualitatively compare the performances of chemotherapy as it has an end as scheduled for adjuvant chemotherapy, or endless precise as in the palliative chemotherapy

Eligibility criteria: Inclusion Criteria:

* 30 major Patients with lung cancer requiring chemotherapy either as palliative or adjuvant as surgical treatment
* 30 significant others (relatives) major applicant lung cancer patients chemotherapy either palliation or as adjuvant to surgery
* 15 Doctors oncologists performing either chemotherapy as palliative or adjuvant as surgical treatment

Exclusion Criteria:

* NA

Primary outcomes:
measure: The semi-structured interview
timeFrame: 1 day (day of inclusion)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04598360: Release of Epoxyeicosatrienoic Acids From Erythrocytes During the Use of Extracorporeal Procedures (Heart-lung Machine)
Official title: A Lipidomics Study: Release of Epoxyeicosatrienoic Acids From Erythrocytes During the Use of Extracorporeal Procedures (Heart-lung Machine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Arteriosclerosis
Valve Heart Disease
Keywords: Fatty Acid Metabolism
Erythrocytes
Lipidomics
Heart-Lung-Machine
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Hypotension with potentially serious consequences for organ perfusion is a common complication in extracorporeal procedures such as heart-lung-machine. The exact reasons for this are still insufficiently clarified. Probably periinterventional vasorelaxant released substances play a crucial role in these procedures. These substances could be due to contact of blood cells with the Membrane in the HLM arise. In this project the hypothesis will be checked, if EETs / DHETs are released by Erythrocytes during this extracorporeal procedure and thus act as potential candidate products for the result of hypotonic phases during usage of heart-lung-machine.

We will determine differences in RBC fatty acids profiling in patients before and after heart-lung-machine intervention. RBC fatty acids profiling will be achieved by using targeted HPLC-MS mass spectrometry.

It is believed that during HLM there is an increase in EETs / DHETs in the serum and in the erythrocytes. It is believed that shear forces play an important role in the release of erythrocyte EETs / DHETs.


Eligibility criteria: Inclusion Criteria:

* Patients who are undergoing an operation with the aid of the heart-lung machine for cardiac surgery
* Age over 18 years
* Ability to consent
* There is a written consent of the study participant

Exclusion Criteria:

•none

Primary outcomes:
measure: Coefficient of variation of relative quantities of erythrocyte fatty-acid parameters related to its dynamic during HLM, using LC-MS / MS.
timeFrame: 4-5months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Experimental & Clinical Research Center
Study officials:
References:
Clinical trial NCT04403360: Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery
Official title: Impact of the Erector Spinae Plane Block on the Postoperative Pain After Lumbar Spinal Stenosis Surgery: Single Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spinal Stenosis
Erector Spinae Plane Block
Lead sponsor: Clinique Saint Pierre Ottignies
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lumbar spinae stenosis surgery is a frequent intervention resulting in important postoperative pain. Management of this postoperative pain is thus important. Different pain management therapies exist. The erector spinae plane (ESP) block was described in 2016. It involves the injection of local anesthetics into the interfascial plane, deep to erector spinae muscle, allowing the blockade of the dorsal and ventral rami of the thoracic spinal nerves. It was initially proposed for analgesia of costal fractures, pulmonary lobectomy and thoracic vertebrae. The ESP block (ESPB) could probably be extended to a large number of surgical procedures. ESPB has so far not been investigated in lumbar spinae stenosis surgery.


Eligibility criteria: Inclusion Criteria:

- Any lumbar spinae surgery on 2 or more lumbar levels

Exclusion Criteria:

* Contraindication to NSAID
* Allergy to any local anesthetics

Primary outcomes:
measure: Total 24 h Piritramide consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Quebec back pain disability scale (QBPDS)
timeFrame: At 2 months]
Other outcomes:
Locations:
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
state: Brabant Wallon
Study officials:
affiliation: Clinique Saint Pierre Ottignies
name: Georges SAMOURI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Clinical trial NCT07016360: Comparison of Effectiveness of Topical Retinoids Versus Liquid Nitrogen in Treatment of Plantar Warts(Viral Infection)
Official title: Comparison of Efficacy of Topical Adapalene Gel Versus Cryotherapy in Recurrent Plantar Warts
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Viral Warts
Keywords: Plantar warts
Topical adapalene gel
Cryotherapy
Lead sponsor: Khyber Teaching Hospital
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a comparative study between two treatment options for skin viral infection.

Detailed description: This is a comparative study between two treatment for viral infection in epidermal layer of skin that proliferates slowly forming thick, growths. This study will compare and evaluate the differences in efficacy between topical liquid nitrogen and topical retinoids.

Eligibility criteria: Inclusion Criteria:

-

Patients age limit 18-60 Years Patients with either gender (Male/Female) Patients with recurrent plantar warts

Exclusion Criteria:

* Pregnancy/lactation. Pt on topical or systemic therapy in last 6 months. On immunosuppressants. \> 5 lesions. Pts with local secondary infections.

Primary outcomes:
measure: Efficacy of Treatment
timeFrame: 06 months
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Khyber Teaching Hospital
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Khyber Teaching Hospital
name: Saba Naz, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01961960: A Study to Evaluate Intramuscular ASP7374
Official title: Phase 3 Study of ASP7374 -Open-label Study of Intramuscular ASP7374 in Adults ≥61 Years of Age-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Vaccine
Keywords: ASP7374
Prevention of seasonal influenza
Lead sponsor: UMN Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-14
Enrollment: 55
Sex: ALL
Minimum age (years): 61
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate safety and immunogenicity of intramuscular ASP7374 in adults ≥61 years of age.


Eligibility criteria: Inclusion Criteria:

* Healthy or medically stable, as judged on the basis of history and concurrent diseases.
* Subject understands procedure of the protocol and is willing to comply with the protocol.
* Written informed consent has been obtained.

Exclusion Criteria:

* Scheduled to receive another vaccine during the study.
* Received influenza HA vaccine within 180 days prior to screening.
* Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine.
* Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome.
* Received one of the following medications or treatment prior to vaccination with the study vaccine: Interferon formulation, Drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, Human immunoglobulin products, Blood products, Blood transfusion
* History of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
* History of seizures, except for febrile seizures in childhood

Primary outcomes:
measure: hemagglutination inhibition (HI) antibody titer
timeFrame: Day 1 and Day 29
Secondary outcomes:
measure: neutralizing antibody titer
timeFrame: Day 1 and Day 29
measure: Local and systemic reactions associated with the vaccination
timeFrame: Day 1 through Day 8
Other outcomes:
Locations:
city: Kanto
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: PRINCIPAL_INVESTIGATOR
References: