louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06515743: Rehabilitation With an Obturator in Maxillary Defects
Official title: Comparison of Quality of Life After Rehabilitation With an Obturator in Maxillary Defects Due to COVID-19 Associated Mucormycosis and Oral Cancer.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mucormycosis
Lead sponsor: Menoufia University
Sponsor class: OTHER
Collaborators: name: Mansoura University
First posted: 2024-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted on 60 patients who underwent maxillectomies between 2020 and 2023. All the patients of 25 years and above who consented for the study were included.

Brief summary: During the COVID-19 pandemic, there was a lot of reporting of COVID-19-associated mucormycosis cases. Managing this condition posed a new challenge to clinicians. Management includes therapeutic drugs and aggressive surgical debridement. Due to the unpredictability of disease prognosis and the possible recurrence of the disease, rehabilitation with delayed surgical obturators is beneficial for patients. Hence, the current study aimed to evaluate the impact of delayed surgical obturators on quality of life of COVID-19-associated mucormycosis patients post-maxillectomies

Detailed description: Globally, the prevalence of mucormycosis varied from 0.005 to 1.7 per million population, while its prevalence is nearly 80 times higher (0.14 per 1000) in India compared to developed countries, in a recent estimate of year 2019-2020.

Among the medical professionals involved in managing patients with mucormycosis, maxillofacial prosthodontists are responsible for prosthetic restoration of lost oral and maxillofacial structures, helping patients to socialize and have an acceptable quality of life after surgical treatment

Eligibility criteria: Inclusion Criteria:

\*Patients who underwent partial, subtotal and hemi-maxillectomy due to COVID-19-associated mucormycosis and who needed the prosthetic rehabilitation with delayed surgical obturator.

Exclusion Criteria:

* Patients who are unwilling for the study.
* Patients who underwent which bilateral maxillectomies.
* Patients having extensive palatal mucosal loss.

Primary outcomes:
measure: Oral healthy related quality of life (oral health impact profile-49)) (OHIP-49)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mohammed A. El-Sawy
Study officials:
affiliation: Menoufia University
name: Mohammed A. Elsawy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01453543: The Effect of Deep Friction Massage on the Achilles Tendon Blood Flow
Official title: The Effect of Deep Friction Massage on the Achilles Tendon Blood Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Situation
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: There is a hypothesis in literature that the mechanical action of deep transverse friction massage (DTF) produces vasodilatation and increases blood flow. But as yet, no experimental study has confirmed the effect of DTF on blood flow in the Achilles tendon. Objective: The purpose of the present study was to investigate whether one session of DTF can influence the Achilles tendon blood flow.

Design: a randomized pre- posttest trial was set up. Patients: Sixty-two healthy participants volunteered. Each person underwent the following four steps of the procedure: 1. Measuring the tendon blood flow (PRE), 2.fifteen minutes of DTF on the Achilles tendon, 3. Measuring of the tendon blood flow (POST), 4.follow - up measurement after 20 minutes of rest (POST20).

Intervention: one leg of each person was randomly assigned to deep transverse friction session, the other leg was used as a control leg. Friction was applied continuously for a total of 15 minutes. Measurements: the microcirculation was determined at 2 and 8 tissue depths at the distal and the proximal midportion of the Achilles tendon. For each level, the capillary blood flow, the tissue oxygen saturation, and the postcapillary venous filling pressure was registered.


Eligibility criteria: Exclusion Criteria:

* a history of lower leg injury
* systematic disease
* persons using drugs
* subjects with circulatory disorders or cardiovascular diseases

Primary outcomes:
measure: Blood flow of the Achilles tendon
timeFrame: after 15 minutes of friction
measure: Blood flow of the Achilles tendon
timeFrame: After 20 minutes of rest.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Erik Witvrouw, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02198443: Comparison of Two Combinations in Antiretroviral Post-Exposure Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open.
Official title: Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this study is to compare the tolerability and adherence to a new drug regimen of post-exposure prophylaxis (PEP) for HIV,


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Have been exposed to HIV, non-occupational and meets the requirements of current recommendations to start with three antiretroviral drugs PEP
* that adequately informed consent in writing to participate in the study and undergo testing and exploration that entails

Exclusion Criteria:

* pregnant women, lactating, or those intend become pregnant during the study period.
* subjects who are known or suspected case presents the source resistors to one of the drugs of the pattern of study
* contraindicated treatment with the study drugs, or products under investigation

Primary outcomes:
measure: Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason
timeFrame: Twenty Eigth days
Secondary outcomes:
measure: Incidence of clinical adverse events and / or laboratory alterations.
timeFrame: twenty-four weeks
measure: Proportion of patients who discontinued treatment due to toxicity or intolerance in each of the treatment arms at 24 weeks follow-up
timeFrame: twenty four weeks
measure: degree of adhesion during the treatment period
timeFrame: twenty eight days
measure: time to loss of adherence to TARV
timeFrame: twenty eight days
measure: Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up.
timeFrame: twenty four weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital clínico y provincial de Barcelona
Study officials:
affiliation: Hospital clínic y provincial de Barcelona
name: Felipe García, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03390543: The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Cardiac Surgical Patients
Official title: The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Cardiac Surgical Patients: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiac Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. sono with simple needle guide device group
2. sono only group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effect of simple needle guide device for ultrasound-guided internal jugular vein catheterization in cardiac surgical patients


Eligibility criteria: Inclusion Criteria:

1. adult ( ≧19 years old)
2. patients undergoing elective cardiac surgery

Exclusion Criteria:

1. emergency surgery
2. patients under cervical immobilization
3. anatomical abnormality
4. infection or hematoma at puncture site
5. patients who did not need internal jugular vein catheterization

Primary outcomes:
measure: First access success rate
timeFrame: up to 5 minutes after insertion of puncture needle
Secondary outcomes:
measure: insertion time
timeFrame: 10 minutes after the beginning of the procedure
measure: complication rate
timeFrame: 24 hours after surgery
measure: ease of procedure
timeFrame: 10 minutes after the beginning of the procedure
measure: The number of attempts
timeFrame: 10 minutes after the beginning of the procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
state: Korea
Study officials:
References:
Clinical trial NCT06731543: Development of an AF Specific Quality of Life Questionnaire: AF-PROMS
Official title: Development of a Condition Specific Quality of Life Scale for Atrial Fibrillation: AF-PROMS
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: City, University of London
First posted: 2024-12-12
Enrollment: 206
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation (AF)

Brief summary: This study is aiming to develop a Health Related Quality of Life (HRQoL) scale for patients who have atrial fibrillation (AF).

Detailed description: This study is aiming to develop and validate a Health Related Quality of Life (HRQoL) scale for patients who have atrial fibrillation (AF). As this questionnaire is currently under development, it is anticipated this measure will be a short questionnaire which will measure various aspects of quality of life. Once the questionnaire has been validated further details of the final metric used and aspects of quality of life covered in the questionnaire can be provided.

Eligibility criteria: Inclusion Criteria:

* Patients with atrial fibrillation (AF)

Exclusion Criteria:

* Exclude any participants who it is felt participation will cause distress.
* Exclude participants who do not give consent to take part in the study

Primary outcomes:
measure: No primary outcomes will be measured
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
Study officials:
References:
Clinical trial NCT01447238: Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy-A Pilot Study
Official title: Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy-A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cysts
Keywords: pancreatic cysts
EUS/FNA
Needle-based Confocal Laser Endomicroscopy (nCLE)
fiber optic imaging
EUS/FNA of pancreatic cysts
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underoing EUS-FNA procedure for pancreatic cyst.

Brief summary: The purpose of this study is to assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE).

Detailed description: Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for an EUS-FNA procedure of a pancreatic cyst,
* Aged above 18 years
* Granted written informed consent for the study can be included in the study.

Exclusion Criteria:

* Contraindication for undergoing EUS/FNA procedure (such as unwilling or medically unstable patients, patients with severe coagulopathy, patients with poor visualization on EUS for various reasons, etc)
* Pregnant or breastfeeding
* Allergy to fluorescein
* Renal insufficiency

Primary outcomes:
measure: Assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE)
timeFrame: From the date of imaging until follow up for 6 months to two years.
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Kenneth J Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nakai Y, Iwashita T, Park DH, Samarasena JB, Lee JG, Chang KJ. Diagnosis of pancreatic cysts: EUS-guided, through-the-needle confocal laser-induced endomicroscopy and cystoscopy trial: DETECT study. Gastrointest Endosc. 2015 May;81(5):1204-14. doi: 10.1016/j.gie.2014.10.025. Epub 2015 Jan 26.
Clinical trial NCT05378438: Impact of Microbe Literacy Initiative on Improved Vaccine Uptake in Peri-urban Slum Areas in Kathmandu, Nepal
Official title: Impact of Microbe Literacy Initiative on Improved Vaccine Uptake in Peri-urban Slum Areas in Kathmandu, Nepal: A Community Based Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaccine Acceptance
Lead sponsor: Nepal Health Research Council
Sponsor class: OTHER_GOV
Collaborators: name: Microbe Literacy Initiative
name: Partnership for Sustainable Development Nepal (PSDNepal)
First posted: 2022-05-18
Enrollment: 1252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is designed to assess the impact of the first introduction of microscope-based health education on people's attitude and practice towards disease prevention in Nepal, measured by vaccine acceptance rate. Such health education has an important role to play in communities where vaccine acceptance is low.


Eligibility criteria: Inclusion Criteria:

* People aged 18 years or older who are resident of the study target area
* People who stayed at least for 6 months on the area of study
* People who agrees with the procedure of study and follow ups visits
* People who provide consent for their participation will be recruited in the study.

Exclusion Criteria:

* People under 18 years of age will not be enrolled into study due to their limitation of understanding and implementation of the content of workshop given as intervention.
* People who do not wish to participate in the trial
* Those with currently ongoing court hearing and deprive of freedom will not be enrolled for the study.

Primary outcomes:
measure: Differential vaccine acceptance rates between intervention and control group
timeFrame: Within 3 months of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Nepal Health Research Council
state: Bagmati
Study officials:
References:
Clinical trial NCT01347190: Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis
Official title: A Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2011-05-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.


Eligibility criteria: Inclusion Criteria:

* Have a confirmed diagnosis of CF: one or more clinical findings consistent with CF and at least one of the following:

  1. Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
  2. A genotype with two identifiable mutations consistent with CF (∆F508 homozygous or two alleles known to cause a class I, II, or III mutation)
* Have an FEV1 ≥30% of predicted normal as defined by age, gender, and height

Exclusion Criteria:

* Oxygen saturation \<90%
* Changed in treatment regimen within 2 weeks prior to screening
* Antibiotics regimen change \< 4 weeks before screening
* Persistent colonization with Burkholderia cepacia
* Serum IgA \< 50% of lower level of normal

Primary outcomes:
measure: Frequency of Adverse events
timeFrame: 44 Days (Day -21 to Day 22)
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Site 11
city: Varna
country: Bulgaria
facility: Site 12
city: Debrecen
country: Hungary
facility: Site 30
city: Bialystok
country: Poland
facility: Site 24
city: Gdansk
country: Poland
facility: Site 22
city: Poznan
country: Poland
facility: Site 21
city: Rabka Zdroj
country: Poland
facility: Site 20
city: Warszawa
country: Poland
facility: Site 23
city: Papworth Hospital
country: United Kingdom
facility: Site 42
city: Penarth
country: United Kingdom
facility: Site 40
city: Southampton
country: United Kingdom
facility: Site 41
Study officials:
affiliation: CSL Behring
name: Program director Clinical R&D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06942390: Topical Metformin Versus Topical Ketotifen in Melasma Treatment
Official title: Topical Metfotmin Versus Topical Ketotifen (Alone or in Combination With Microneddling)in Melasma Treatment :Comparative Split Face Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Melasma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 60
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 study aims to evaluate and compare the efficacy and safety of a new formulation of topical metformin (nanoparticles) versus topical ketotifen (nanoparticles), both alone and combined with micro-needling, for the treatment of melasma. It is a double-blinded, randomized, split-face controlled clinical study involving 102 female patients diagnosed with bilateral melasma.

Detailed description: This research investigates the therapeutic effects of two nanoparticle-based topical treatments-metformin and ketotifen-on melasma. The study employs a split-face design where each patient receives different treatments on each half of their face. Patients are divided into two groups:

Group 1: Undergoes micro-needling sessions for the entire face, followed by the application of topical ketotifen on one half and topical metformin on the other half.

Group 2: Receives only topical applications of ketotifen on one half of the face and metformin on the other half without micro-needling.

The study includes detailed pre-procedure preparation (cleaning and anesthetizing the face) and post-procedure care (application of SPF 50+ sunblock). Clinical assessments include photographic documentation, H-MASI and mH-MASI scoring for melasma severity, patient satisfaction surveys, MELASQOL questionnaires to assess quality-of-life impacts, and monitoring for side effects. Assessments are conducted at baseline, monthly during treatment, and one month after the final session.

Eligibility criteria: Inclusion Criteria:

* Female adults of 18 years and above with bilateral melasma .
* Clinical diagnosis of melasma.
* Mental capacity to give informed consent.

Exclusion Criteria:

* Pregnant or nursing women.
* Current use of hormonal birth control medication or any hormonal therapy.
* Current or previous treatment by depigmenting agents within 3 months
* History of laser or MN to the face within 3 months of study enrollment.
* Patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar/keloids.
* Photosensitivity.
* Patients with unrealistic expectations.

Primary outcomes:
measure: Reduction in Melasma Severity Index (MASI) Score
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiot university
name: Radwa Bakr, Assistant professor
role: STUDY_DIRECTOR
References: