louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01351363: Prediction Of Post Operative Pain Following Arthroscopic Shoulder Surgery
Official title: PREDICTION OF POST OPERATIVE PAIN FOLLOWING ARTHROSCOPIC SHOULDER SURGERY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroscopic Shoulder Surgery
Pain Threshold
Keywords: Arthroscopic shoulder surgery
Pain threshold
Lead sponsor: NHS Fife
Sponsor class: OTHER_GOV
First posted: 2011-05-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Following arthroscopic shoulder surgery a small but significant number of people suffer severe postoperative pain.

This study aims to predict which patients are at risk of developing severe post operative pain so that they may be targeted with a more aggressive post operative pain regimen.

Detailed description: Patients presenting for elective (day case) arthroscopic shoulder surgery for either Arthroscopic Subacromial Decompression (ASD Group) or Rotator Cuff Repair (RCR Group) are recruited. Using a Cefar PainMatcher, a pain and sensory threshold assessment tool, consenting patients will have their preoperative pain thresholds recorded. The patients will then have a standard anaesthetic administered with TIVA (propofol/remifentanil) and either a subacromial injection (ASD Group) or interscalene block (RCR Group). Four days following surgery a telephone questionnaire will be completed by the patients recording their worst pain score since surgery.

Eligibility criteria: Inclusion Criteria:

* All patients aged 18 years or older able to give informed consent undergoing arthroscopic shoulder surgery at NHS Fife (ASD or rotator cuff repair)

Exclusion Criteria:

* Unable to give informed consent
* Allergy to remifentanil, propofol or levobupivacaine.
* Absence of contralateral arm (thumb/fingers)
* Documented sensory abnormality (e.g. peripheral neuropathy)
* Those not consenting to subacromial injection or interscalene block intraopertively (part of routine management after surgery).
* Psychiatric disease (documented history in Hospital notes or GP referral summary)
* Drug or alcohol misuse (suspicion of or documented)
* No telephone or unable to communicate in English (no interpreter service available)

Primary outcomes:
measure: Post operative pain level
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kirkcaldy
country: United Kingdom
facility: Victoria Hospital
state: Fife
Study officials:
affiliation: NHS Fife
name: Anthony Davis, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis A, Chinn DJ, Sharma S. Prediction of post-operative pain following arthroscopic subacromial decompression surgery: an observational study. F1000Res. 2013 Feb 4;2:31. doi: 10.12688/f1000research.2-31.v1. eCollection 2013.
Clinical trial NCT01320163: Clinical Acceptability of I-GEL® in Pediatric Patients: Comparison of Clinical Performance With Classic-LMA™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 108
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to determine whether a functional difference exists between the laryngeal mask airway (LMA)-Classic™ and i-gel in anesthetized children who have received neuromuscular blockade.


Eligibility criteria: Inclusion Criteria:

* ASA I-II, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary

Exclusion Criteria:

* Patients will be excluded from the study if they present as Mallampati III or IV, ASA III-V or emergency status
* upper airway abnormality

Primary outcomes:
measure: airway leak pressure
timeFrame: within 5 min of insertion of each device
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
Clinical trial NCT01474863: Citrulline in Severe Sepsis
Official title: Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous Citrulline to Prevent or Mitigate Acute Lung Injury in Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe Sepsis
Acute Lung Injury
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2011-11-18
Enrollment: 72
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate biochemical, clinical, and safety effects of 2 doses of intravenous L-citrulline compared to placebo in patients with severe sepsis at risk for or with acute lung injury. The hypothesis is that intravenous L-citrulline will decreased the development or progression of acute lung injury in patients with severe sepsis compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Severe Sepsis

Exclusion Criteria:

* No Consent
* Malignant or other irreversible condition
* Moribund and not expected to survive 48 hours
* End Stage Liver Disease
* Enrolled in another IND study
* Pregnant or breast feeding female
* Age\<13 years old
* Allergy to citrulline or arginine

Primary outcomes:
measure: Vasopressor Dependency Index
timeFrame: day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Todd Rice, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04871763: Assessment of Bacterial Loads of Essix Retainers in Patients Under Retention Therapy
Official title: A Protocol for the Assessment of the Bacterial Loads of Essix Retainers in Patients Under Retention Therapy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance Complication
Keywords: oral microbiota
essix retainer
periodontal assessment
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the bacterial loads present on essix retainers in patients' contention therapy. Patients are randomly divided into three groups, depending on the product used for the cleansing of the retainers: Geldis, Polident tablets and water. Microbiological samples were taken from the retainers at the baseline, after 1 and after 2 months, together with Bleeding Index, Plaque Index, BEWE Index and Schiff Air Sensitivity test.

Detailed description: The aim of this study is to investigate the bacterial loads present on essix retainers in patients' contention therapy. Patients who wear essix retainers for contention therapy are randomly divided into three groups, depending on the product used for the cleansing of the retainers: Geldis, Polident tablets and water. Periodontal evaluation and microbiological samples are conducted at the baseline, after 1 and after 2 months.

Bacterial loads are collected from essix retainers, whereas Bleeding Index, Plaque Index, BEWE Index and Schiff Air Sensitivity test are assessed from the patients' mouth.

Eligibility criteria: Inclusion Criteria:

* Patients who completed orthodontic treatment and under Essix retainers phase.

Exclusion Criteria:

* Patients under orthodontic treatment with fixed appliances or clear aligners.
* Non-orthodontic patients.

Primary outcomes:
measure: Change in PCR% - Plaque Control Record (percentage)
timeFrame: Study begin, 1 and 2 months
measure: Change in BOP - Bleeding on Probing (percentage)
timeFrame: Study begin, 1 and 2 months
measure: Change in Schiff Air Index - Dental sensitivity test
timeFrame: Study begin, 1 and 2 months
measure: Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)
timeFrame: Study begin, 1 and 2 months
measure: Change in microbiological loads of clear aligners
timeFrame: Study begin, 1 and 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02568163: Influence of Stress on Non Surgical Periodontal Treatment
Official title: Influence of Stress on Non Surgical Periodontal Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Treatment of periodontal diseases is influenced by several risk factors. Psychological stress is considered as one of them. Aim of this study is to assess if stress influences results of non surgical periodontal treatment in severe chronic forms of periodontitis.


Eligibility criteria: Inclusion Criteria:

* Severe generalized chronic periodontitis
* Minimum 15 teeth
* Attachment loss \> 5mm
* 30% of sites affected- 5% of pockets\>5mm
* Bone loss- Bleeding on probing

Exclusion Criteria:

* Patient at risk of endocarditis
* Pregnant women
* Patient under therapy for depression
* Patient treated for periodontal diseases previously

Primary outcomes:
measure: Changing depths of periodontal pockets
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de parodontologie
state: Bas Rhin
Study officials:
References:
Clinical trial NCT02256163: Identification of Genes and Pathogenesis Involved in Familial Thoracic Aortic Aneurysm
Official title: Identification of Genes and Pathogenesis Involved in Familial Thoracic Aortic Aneurysm (TAA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Aortic Aneurysm
Keywords: Thoracic Aortic Aneurysm (TAA)
gene
familial TAA
blood collection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrollement of individuals and families followed in the reference centers and the competence centers,

* search for mutations in one of known genes such as FBN1, TGFBR1, TGFBR2, ACTA2, or MYH11.
* search for new genes in families and individuals with TAA who without mutation in one of the known genes.

Brief summary: The primary objectives of the study are

* to assess the contribution of alteration of each known gene on non-syndromic TAA.
* to map and identify unknown gene involved in the non-syndromic TAA.

Detailed description: The secondary objectives of the study are

* to study the correlation of phenotype-genotype, in particular, to compare the aortic phenotype of non-syndromic TAA patients and TAA syndromic patients.
* to develop national standardized strategies of genetic diagnosis and of clinical management using genetic data.

Eligibility criteria: Inclusion Criteria:

For all:

* Aged \> 18 years.
* Written informed consent obtained.
* People with health insurance.

For individual:

* people ≥ 45 years, thoracic aortic aneurysm without syndrome,
* or people \> 45 years with familial TAA.

For family:

* At least 2 members of family in 2 generations have TAA without syndrome and at least 2 patients of TAA will undergo blood collection.
* All people in family will undergo blood collection, each member should declare at first his (her) status (with or without TAA, unknown), the relationship (direct relative family or family in-law), no limit of age. For the children, only those with TAA will perform blood collection for the study.

Exclusion Criteria:

* Thoracic aortic aneurysm with different syndromes (Marfan syndrome, Ehlers-Danlos syndrome, Loeys-Dietz syndrome, Turner syndrome, Noonan syndrome).
* Arterial hypertension.

Primary outcomes:
measure: Impact of known mutations and research of new genes involved in non syndromic TAA
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Département de Génétique, Hôpital Bichat
state: Ile De France
Study officials:
affiliation: Département de Génétique, Hôpital Bichat, France
name: Catherine Boileau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06646263: Cellular Immune Responses in Triple-negative Breast Cancer - High Throughput Immunogenetic Studies
Official title: Cellular Immune Responses in Triple-negative Breast Cancer - High Throughput Immunogenetic Studies
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Triple Negative Breast Cancer
Keywords: T cells
Tumor-infiltrating lymphocytes
Next-generation sequencing
T cell receptor
Spatial transcriptomics
Neoepitopes
TR beta chain
TRb clonotypes
TRb gene repertoire
Cellular immunity
Lead sponsor: Institute of Applied Biosciences
Sponsor class: OTHER
Collaborators: name: Hellenic Cooperative Oncology Group
First posted: 2024-10-17
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group includes patients diagnosed with TNBC. Each patient provided written informed consent, and paired samples of peripheral blood (PB) and tumor tissue were obtained at the time of diagnosis and before initiating any treatment. The selection of patients will be meticulously carried out by the PI and team members based on comprehensive clinical records, including clinicobiological characteristics. Further refinement of the study group will be contingent upon sample availability and the quality of biological material.

Brief summary: This project introduces a novel methodology for the in-depth immunogenetic characterization of the TR gene repertoire in solid tumors, holding the promise to offer unprecedented insights into the TR anti-tumor specificity and the prognostic/predictive value of TR gene repertoire signatures.

Detailed description: The goal of this observational study is to address the role of T cells in the tumor microenvironment of TNBC.

In detail, this study aims to:

(i) explore the immunogenetic characteristics of the TR gene repertoire as informative prognostic/predictive biomarkers in TNBC (ii) identify immunogenic neoepitopes arising from common tumor-specific non-synonymous gene mutations, as well as the corresponding neoepitope-specific T cells (iii) describe, in single-cell resolution, the spatial organization of the intricate crosstalk between tumor cells and neoepitope specific-T cells, and (iv) delineate the functional properties of T cells within the TME.

All the experimental results, regarding the TR repertoire features and the spatial organization of the TME, will be correlated with clinical outcome measurements (e.g. overall survival, progression time), which are available from the detailed patients medical record.

Eligibility criteria: Inclusion Criteria:

- Confirmed TNBC diagnosis

Exclusion Criteria:

-

Primary outcomes:
measure: T cell receptor profiling as a potential biomarker in Triple-Negative Breast Cancer
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Institute of Applied Biosciences
Study officials:
References:
Clinical trial NCT02884063: Utilizing Free DNA in Embryo Culture for PGT
Official title: Utilizing Free DNA in Embryo Culture Media for Preimplantation Genetic Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chromosome Abnormalities
Genetic Diseases, Inborn
Mutation
Keywords: PGS
PGD
free embryo DNA
NGS
PGT
PGT-a
PGT-m
PGT-HLA
Lead sponsor: Al Baraka Fertility Hospital
Sponsor class: OTHER
Collaborators: name: Ibn Sina Hospital
name: Sadat City University
First posted: 2016-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Embryos arranged for PGS study

Brief summary: In the way for developing and optimizing protocol to be used as non- invasive methodology used as routine testing for PGS.

This protocol is to be adapted to replace the using of life embryo cells for genetic testing and aneuploidy study as well as for any type of genetic testing including single gene disorder or HLA typing or study.

Detailed description: Compare 100 embryos studied using NGS for chromosomal aneuploidies, and compare the results came from free media DNA with this results.

Eligibility criteria: Inclusion Criteria:

* all abnormal/aneuploidy embryos rejected for embryo transfer.

Exclusion Criteria:

* all embryos had unsuccessful diagnosis with blastomere biopsy.

Primary outcomes:
measure: DNA isolation
timeFrame: 2 years
Secondary outcomes:
measure: NGS evaluation
timeFrame: 2 years
measure: Comparison with cell reading using NGS
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Genetic Engineering Institute
name: Omima Khamis, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01233635: Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)
Official title: Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In the present application, we propose to refine and extend current insight into AAF mechanism and therapy by examining the importance of pharmacologic RAAS inhibition, ACE genotype, and their interaction in secondary AF prevention. We have 3 specific aims:

1. To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.
2. To test the hypothesis that the incidence of AF recurrence in the absence of RAAS inhibition therapy is higher among patients with the D allele.
3. To explore the hypothesis that RAAS inhibition therapy is more effective for preventing AF recurrence in patients with the DD genotype than in those with DI or II genotypes.


Eligibility criteria: Inclusion Criteria:

* Subjects must be in atrial fibrillation confirmed by 12 lead EKG.
* blood pressure \> 90 mmHg
* Patient without cardiopulmonary symptoms
* 18+ years of age

Exclusion Criteria:

* Contraindiction to warfarin
* Recent (within 6 months) MI or cardiac revascularization
* Recent (within 6 months) CVA or TIA
* NYHA Class IV CHF
* Active thyroid disease
* Major hepatic dysfunction
* Renal dysfunction (\>2 mg/dL)
* Hyperkalemia (\>4.6 mEq/L)
* Hyponatremia (\<130 mEq/L)
* Currently taking a Vaughn-Williams Type I or III antiarrhythmic drug
* History of ARB intolerance
* Contraindication to ARB therapy
* Pregnancy
* Female of childbearing age
* Age \< 18 years of age
* Inability to give informed consent
* Other medical conditions calling 1 year survival into question

Primary outcomes:
measure: AF burden
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC CVI
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05128435: Coronavirus Pediatric Serological Study
Official title: Coronavirus Pediatric Serological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection
Keywords: SARS-CoV-2
Immune response
Children
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 49
Sex: ALL
Minimum age (years): 0
Maximum age (years): 179
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 15 years old

Brief summary: The Coronavirus Pediatric Serological Study's aim is to provide a better insight of children's immune response after SARS-CoV-2 infection.

Serological tests were conducted on blood samples taken 3 to 5 months after the children's viral infection.

The study was performed in collaboration with the Institute of Medical Immunology, were antibody levels were measured and immunoglobulin subclasses profiles were studied.

Detailed description: The hospital laboratory provided us the list of children under 15 years old tested for SARS-CoV-2 in Saint-Pierre Hospital (Brussels) by PCR on nasopharyngeal swab between March 1 2020 and December 31 2020.

The medical files of all children that were tested positive for SARS-CoV-2 were reviewed and clinical information was collected.

For each positive child, the family was contacted by phone 3 months after the proven viral infection in order to ask permission to take a single blood test.

Covid19 serologies were performed in the hospital laboratory, and blood samples were then sent to the Institute of Medical Immunology, were antibody levels and immunoglobulin subclasses were studied.

Eligibility criteria: Inclusion Criteria:

- Tested positive for SARS-CoV-2 by PCR on naso-pharyngeal swab performed in Saint-Pierre Hospital (Brussels) between March 1 2020 and December 31 2020

Exclusion Criteria:

* /

Primary outcomes:
measure: SARS-CoV-2 antibody levels in asymptomatic patients
timeFrame: 3 to 5 months after SARS-CoV-2 infection
measure: SARS-CoV-2 antibody levels in mildly symptomatic patients
timeFrame: 3 to 5 months after SARS-CoV-2 infection
measure: SARS-CoV-2 antibody levels in hospitalized patients
timeFrame: 3 to 5 months after SARS-CoV-2 infection
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Saint-Pierre Hospital
Study officials:
References: