louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04351542: Ayurveda for Flu Like Illness During Covid-19 Outbreak
Official title: Ayurveda for Flu-like Illness During the Covid 19 Outbreak: Non Randomised Single-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flu Like Illness
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to evaluate the efficacy and safety of Ayurveda in reducing symptoms of flu like illness during the Covid 19 outbreak.


Eligibility criteria: Inclusion Criteria:

* Patients with fu like symptoms within 48 hours of onset during March2020
* Mild to moderate symptoms who were advised to self isolate at home for 7-14 days
* Flu like symptoms present at least one respiratory symptom (e.g. cough, nasal obstruction, sore throat) and at least one constitutional symptom other than fever (e.g. fatigue, headache, myalgias) of less than 48-hour duration
* Willing to consent and follow up

Exclusion Criteria:

* Pregnant/lactating

  * Participants with chronic pulmonary diseases or critical condition or already developed severe respiratory distress
  * Clinically malignancies, systemic infection, other medical or psychiatric condition which places the subject at unacceptable risk to participate in the study - Known hypersensitivity to any ayurveda herbal substances
* Severe symptoms of respiratory distress patients deemed to require intensive care immediately

Primary outcomes:
measure: Time to achieve afebrile
timeFrame: Change from baseline to 3rd and 7th-day
measure: Severity of symptom score
timeFrame: Change from baseline to 3rd and 7th day
Secondary outcomes:
measure: Patient reported improvement
timeFrame: Change from baseline to 3rd and 7th-day
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Aarogyam
Study officials:
affiliation: Aarogyam UK
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Jaydeep Joshi, BAMS
role: STUDY_DIRECTOR
References:
Clinical trial NCT05762042: Comparison of the Efficacy and Tolerability of Femal Versus Placebo
Official title: Comparison of the Efficacy and Tolerability of Femal Versus Placebo in the Treatment of Hot Flashes in Patients With Previous Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Menopause
Lead sponsor: Azienda Ospedaliera Ordine Mauriziano di Torino
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 34
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Femal, a food supplement based on pollen extracts introduced in Europe in 1999, is a non-estrogenic alternative to hormone replacement therapy in women with vasomotor symptoms.

Patients with prior breast cancer, spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by GNRH analogue and experiencing severe vasomotor symptoms (at least 20 hot flashes per week) will be included.

Patients who are on tamoxifen or anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry.

Patients on SSRI or SNRI antidepressant therapy are excluded. Eligible patients will be randomly assigned to either Femal (2 cp/day) or placebo (2 cp/day) for 3 months (double-blind study).


Eligibility criteria: Inclusion Criteria:

- patients with a history of breast cancer, in spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by GNRH analogue and experiencing severe vasomotor symptoms (at least 20 hot flushes per week).

Patients who are on tamoxifen or aromatase anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry

Exclusion Criteria:

* Patients on SSRI or SNRI antidepressant therapy are excluded

Primary outcomes:
measure: efficacy of Femal in reducing the mean score of vasomotor symptoms between baseline (T0) and month 3 (T2).
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Roma
country: Italy
facility: Policlinico Gemelli di Roma
Study officials:
References:
Clinical trial NCT05469542: Everbeat Ring ECG Clinical Concordance Study
Official title: Correlation of Electrocardiographic Signals Acquired by a Finger-worn ECG Sensor With a Standard 12-Lead ECG
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Keywords: ECG
Wearables
Electrocardiography
Lead sponsor: Grektek Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-21
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-90 presenting for a routine internal medicine or cardiology clinic visit

Brief summary: This study is a cross-sectional observational study conducted in patients referred for routine ECG, to compare output from the everbeat finger-worn ECG device to standard of care (SOC) 12-lead electrocardiography. No intervention is involved in this study. Patients visiting the study site during the study period will be assessed for eligibility on a convenience basis, and observational data will be recorded on those eligible.


Eligibility criteria: Inclusion Criteria:

* Males or females aged 18 to 90 years.
* Under the care of a board-certified physician and referred for a routine electrocardiogram (ECG)
* Resting heart rate between 50 to 120 beats per minute (BPM).

Exclusion Criteria:

* Inability to wear the everbeat ring.
* Prior history of movement disorders including Parkinson's or benign tremors.
* Prior history of allergic skin reactions to metal including stainless steel.

Primary outcomes:
measure: R-wave Amplitude
timeFrame: 50 days
measure: ST-segment
timeFrame: 50 Days
measure: Blinded Cardiologist Review
timeFrame: 50 Days
Secondary outcomes:
measure: User acceptance survey
timeFrame: 50 days
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: BKLYNCardio
state: New York
Study officials:
References:
Clinical trial NCT06776042: Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery
Official title: Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to understand the mechanisms leading to olfactory dysfunction (OD) in chronic rhinosinusitis (CRS). The main questions it aims to answer are:

* Is the type 2 inflammation impacting the olfactory epithelium regeneration, leading to OD?
* Does a treatment interfering with one of the major T2 inflammatory cytokines, have an impact on the mechanisms of OD in CRS?

Participants will undergo olfactory testing and nasal brushing before and after 3 months of treatment.


Eligibility criteria: Inclusion Criteria:

* At least two of the following symptoms: nasal obstruction, rhinorrhoea, smell loss, facial pain for 12 weeks.
* Endoscopic visualisation of bilateral sinonasal polyps
* SSI (TDI) \< 30.75 and decreased sense of smell subjectively
* Eosinophilia \> 300/μl of blood Ku/l
* On a stable nasal steroid treatment for at least 4 weeks

Exclusion Criteria:

* Active smoking
* Primary and secondary immune deficiencies
* Ciliary diseases (cystic fibrosis, primary ciliary diskinesia)
* History of or current nasal malignancies
* \< 18 years and \> 70 years
* Patients unable to express consent
* Use of systemic corticosteroids for \< 4 weeks before visit 1 • Use of systemic or local antibiotics for \< 4 weeks before visit 1

Primary outcomes:
measure: Genetic profile comparison after single-cell RNA sequencing
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Functional characterization of olfactory epithelium
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Valérie Hox, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02361242: 24-week Open-label Extension Study Evaluating PXT00864 Effect in Mild AD Patients Further to PLEODIAL-I Completion
Official title: 24-week Open-label Extension Study Evaluating the Effect of PXT00864 in Mild Alzheimer's Disease Patients Further to PLEODIAL-I Completion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: PXT00864
mild AD
phase 2a
Lead sponsor: Pharnext S.C.A.
Sponsor class: OTHER
Collaborators: name: Ascopharm Groupe Novasco
First posted: 2015-02-11
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PLEODIAL-II study is an extension of the previous pilot PLEODIAL-I study (CLN-PXT00864-03 protocol) and is designed for the descriptive analysis of patients with mild AD who are exposed to PXT00864 over an additional 24-week period.

Detailed description: Patients having completed the previous 12-week PLEODIAL-I study were eligible to receive PXT00864 in this 24-week open-label extension PLEODIAL-II study in order to collect some additional long-term data regarding the safety and the potential effect of PXT00864 on cognitive and behavioural impairments.

Eligibility criteria: Main Inclusion Criteria:

* Mild Alzheimer's Disease patient who was included in PLEODIAL-I study
* Mini Mental State Examination (MMSE) score greater or equal to 20

Main Exclusion Criteria:

* Patient who was not compliant with the previous PLEODIAL-I study protocol
* Patient who experienced significant adverse events which necessitated treatment discontinuation during the PLEODIAL-I study

Primary outcomes:
measure: Change from Baseline in the total score of the 11-items Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
timeFrame: V5 (study entry), V6 (after 12 weeks), V7 (after 24 weeks)
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: throughout the 24-week study period
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CMRR
Study officials:
affiliation: Hospital Pellegrin, Bordeaux, France
name: Jean-Marc Orgogozo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02357342: Sirolimus Versus Anti-Vascular Endothelial Growth Factor (antiVEGF) for Wet AMD
Official title: Sirolimus Versus AntiVEGF for Wet AMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Lead sponsor: Maturi, Raj K., M.D., P.C.
Sponsor class: INDIV
First posted: 2015-02-06
Enrollment: 40
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: Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous AntiVEGF treatment.

Detailed description: Forty subjects will be randomized to receive intravitreal Sirolimus or standard of care treatment in a 1:1 ratio. Over the course of the six month trial plus a 6 month optional extension, subjects will be evaluated monthly. Treatment with Sirolimus will be given at baseline, month 2 and month 4 with sham injections given at months 1, 3 and 5. For subjects in the extension Sirolimus will also be given at months 6, 8 and 10 with sham at month 7, 9, and 11. Subjects in the standard of care group will receive anti-VEGF injections or sham monthly. Retreatment criteria will be based upon continued subretinal edema, intraretinal edema or active chorioretinal neovascularization (CNV)

Eligibility criteria: Inclusion Criteria:

* best corrected visual acuity of 5-65, inclusive, in study eye
* presence of choroid neovascularization secondary to AMD
* persistent edema despite at least 3 previous intravitreal anti-VEGF injections in the past 5 months

Exclusion Criteria:

* greater than 100 micron decrease in central subfield thickness on Optical Coherence Topography (OCT) since last standard of care visit
* history of major ophthalmic surgery in the study eye in the past 3 months
* history of significant ocular disease or condition other than exudative AMD that may confound results

Primary outcomes:
measure: Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography
timeFrame: Baseline to 6 months
measure: Visual Acuity
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Visual Acuity (Best Corrected Visual Acuity)
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Raj K Maturi MD PC
state: Indiana
Study officials:
affiliation: Raj K. Maturi, MD, PC
name: Raj K Maturi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Minturn RJ, Bracha P, Klein MJ, Chhablani J, Harless AM, Maturi RK. Intravitreal sirolimus for persistent, exudative age-related macular degeneration: a Pilot Study. Int J Retina Vitreous. 2021 Feb 16;7(1):11. doi: 10.1186/s40942-021-00281-0.
Clinical trial NCT02959242: Dresden Glaucoma and Treatment Study (DGTS)
Official title: Dresden Glaucoma and Treatment Study: Analysis to Assure the Quality of Follow-up and Therapy of Glaucoma Patients in a Tertiary University Hospital Glaucoma Service.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glaucoma
Glaucoma, Open-Angle
Glaucoma, Angle-Closure
Glaucoma, Low Tension
Keywords: Follow-up intervals
Treatment Efficiency
Laser Therapy
Glaucoma Surgery
Minimal Invasive Glaucoma Surgery (MIGS)
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma patients attending a tertiary University Hospital glaucoma Service.

Brief summary: To assure the quality of follow-up and treatment, data of glaucoma patients are stored and evaluated after anonymisation.

Detailed description: The aim of the study is to evaluate the quality of follow-up and treatment by means of consecutive data collection and anonymised analysis of all glaucoma patients of a tertiary university hospital glaucoma service.

Parameters being analyzed are:

Age, sex, refraction, family history, known duration of glaucoma, highest intraocular pressure before treatment, systemic and topical medication, previous ocular surgery.

24h Goldmann-applanation tonometry, biomicroscopy, gonioscopy, Heidelberg Retinal Tomograph (HRT), glaucoma diagnosis with Scanning-Laser-Polarimetry (GDx), optical coherence tomography (OCT), Pentacam, Ocular Response Analyzer (ORA), Corvis ST (Corneal Visualization with the Scheimpflug Technology), perimetry

Eligibility criteria: Inclusion Criteria:

* manifest glaucoma, ocular Hypertension, glaucoma suspect

Exclusion Criteria:

* under 18 years of age, corneal diseases

Primary outcomes:
measure: Follow-up intervals
timeFrame: 20 years
Secondary outcomes:
measure: Assessment of treatment quality
timeFrame: 20 years
measure: Assessment of intraocular pressure-lowering efficacy and number of participants with treatment-related adverse events as assessed by CTCAE v4.0 of glaucoma laser therapy
timeFrame: 20 years
measure: Assessment of intraocular pressure-lowering efficacy and number of participants with treatment-related adverse events as assessed by CTCAE v4.0 of glaucoma laser therapy of glaucoma surgery
timeFrame: 20 years
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Eye Hospital, Medical Faculty, Technical University Dresden
state: Saxony
Study officials:
affiliation: Medical faculty of the Technical University of Dresden, Germany
name: Lutz E Pillunat, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02281942: Behavioral Interventions to Target Self-Control
Official title: Behavioral Interventions to Target Self-Control in Abstinent Nicotine Dependent Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low self-control has been associated with a number of unhealthy behaviors with low treatment success. Alternative non-pharmacological approaches have the potential for enhancing self-control. This pilot study will investigate if the practice of yoga and/or health and wellness education improve self-control in the context of nicotine addiction, and will set the stage for larger clinical trials using behavioral interventions to supplement or replace existing treatments and increase the rates of recovery from disorders in which low self-control is a susceptibility factor.


Eligibility criteria: Inclusion Criteria:

* should smoke a minimum of 10 cigarettes/day
* be fluent speaking and reading English
* in good physical health
* intend to quit smoking
* capable of abstaining from smoking for 12-14 hours
* should have easy daily access to a computer and/or other internet-enabled device

Exclusion Criteria:

* current alcohol or substance use disorder (except nicotine)
* pregnancy
* history of psychosis or bipolar disorder
* current use of a behavioral or pharmacologic tobacco treatment
* any untreated medical or psychiatric condition that might compromise their safety during participation in the study (e.g. high blood pressure, diabetes, BMI \>35)

Primary outcomes:
measure: Time (minutes) to first smoke after 12-hour abstinence
timeFrame: Assessed 1 week after visit 1 during a 2-hour abstinence reinforcement session
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Laura Carim Todd, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00738842: Uric Acid Study in Healthy Male Volunteers
Official title: A Randomised, Double-Blind, Two-Period Crossover Study to Assess the Effect of AZD6140 on Uric Acid Levels in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Coronary Artery Disease
Keywords: Uric
Acid
Level
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-21
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being conducted to examine the effect of AZD6140 on the levels of certain chemicals in subjects' blood and urine.


Eligibility criteria: Inclusion Criteria:

* Normal physical examination, vital signs, electrocardiogram (ECG) and laboratory values (unless the investigator considers an abnormality not to be clinically significant)
* Normal laboratory tests at screening
* Non-smoker (no cigarette/tobacco use for at least 6 months)

Exclusion Criteria:

* Personal or family history of gout, gouty arthritis, or renal stones

Primary outcomes:
measure: The effect of AZD6140 on the levels of certain chemicals in subjects' blood and urine.
timeFrame: Levels or certain chemicals in subjects' blood and urine will be measured at scheduled times during the first 7 days of the study.
Secondary outcomes:
measure: The blood levels of AZD6140 in various subjects on the same diet.
timeFrame: following dosing during the first 5 days of the study
measure: The effect of taking AZD6140 on the levels of certain hormones in urine
timeFrame: during the first 5 days of the study
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Kathleen Butler, MD
role: STUDY_DIRECTOR
affiliation: SeaView Research
name: Stuart Harris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03371342: Treatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder
Official title: A Randomized, Double-blind, Active Controlled, Multi-center, Phase 1 Study to Investigate the Safety of MEDITOXIN® in Female Subjects With Idiopathic Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overactive Bladder
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2017-12-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the safety of MEDITOXIN in female subjects with idiopathic overactive bladder compared with BOTOX


Eligibility criteria: Inclusion Criteria:

* Female aged more than 20 years
* Subject who has symptoms of Overactive Bladder for a period of at least 6 months immediately prior to screening

Exclusion Criteria:

- Patient not appropriate for participating in this study according to the investigator's opinion

Primary outcomes:
measure: Change from baseline in adverse events of MEDITOXIN at 12 week
timeFrame: baseline, week 12 follow up visits
Secondary outcomes:
measure: Change from baseline in the daily average number of episodes of urinary incontinence
timeFrame: baseline, week 12 follow up visits
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: