louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06540651: Efficacy of Light Therapy in Treatment of Chronic Cluster Headache
Official title: Proof-of-concept Study on the Efficacy of Light Therapy in the Prophylactic Treatment of Chronic Cluster Headache
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cluster Headache
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 48
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: Cluster headache is a primary headache. The chronic form of the disease is often difficult to treat. It is now considered a chronobiological disease. This chronobiological character is based on clinical, biological and radiological arguments.

This study focuses on the use of light therapy in cluster headache. Light therapy has already been used in the treatment of other chronobiological diseases, such as seasonal depression, but also recently in the therapy of other primary headaches (such as migraine). Its aim is to re-adjust chronobiological rhythms, and it therefore seems worth testing in the chronic form of cluster headache.

Light therapy is delivered to the patient using a consumer electronics device.The main objective is to evaluate the prophylactic efficacy of light therapy in patients with chronic cluster headache.


Eligibility criteria: Inclusion Criteria:

* Male or female, of 18 years years old or more;
* Diagnosis of chronic cluster headache according to ICHD-3 criteria;
* Number of seizures during baseline equal to at least 24;
* Stability of prophylactic treatment for at least 1 month and commitment not to change it for the duration of the study;
* Patient affiliated to the French social security system.
* Patient who understands and speaks French correctly;
* Patient who has given free and informed written consent.

Exclusion Criteria:

* Contraindication to the use of light therapy: use of a photosensitizing treatment;
* Ophthalmological history: cataract, macular degeneration, glaucoma, retinitis pigmentosa;
* Patients who work at night;
* Other neurological, psychiatric or developmental pathologies considered incompatible with the study;
* Background treatment of cluster headache with melatonin;
* Persons protected by articles L1121-5, L1121-6 and L1121-8 of the French Public Health Code (pregnant or breast-feeding women, persons deprived of their liberty by judicial decision, socially vulnerable persons, adults incapable or unable to express their consent).

Primary outcomes:
measure: The median weekly number of cluster headache attacks
timeFrame: At day 28
Secondary outcomes:
measure: Incidence and nature of adverse reactions
timeFrame: Daily
measure: Intensity of cluster headache
timeFrame: Daily
measure: Use of acute treatments
timeFrame: Daily
measure: Patient's Global Impression of Change (PGIC) score
timeFrame: At day 28
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital La Timone
city: Nice
country: France
facility: Hôpital de Cimiez
Study officials:
References:
Clinical trial NCT02708251: Glyceryl Trinitrate Versus Lidocaine Cream for IUD Insertion
Official title: Topical Glyceryl Trinitrate Versus Lidocaine Cream as Analgesia for IUD Insertion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: IUD Insertion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive method that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method.


Eligibility criteria: Inclusion criteria:

1. Women not taken analgesics or anxiolytics in the 24 hours prior insertion
2. Women not taken misoprostol prior to IUD insertion
3. No contraindication to or history of allergic reaction to lidocaine or NO donors.
4. Women who will accept to participate in the study

Exclusion criteria:

1. Lidocaine allergy
2. History of migraine or chronic headache
3. Any contraindication to IUD placement

Primary outcomes:
measure: Mean pain score during IUD insertion
timeFrame: 3 minutes
Secondary outcomes:
measure: Patient satisfaction score after the procedure
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
citation: Abbas AM, Ragab E, Abd Ellah NH, Sabra A, Ali SS, Mohamed A, Yosef AH. Effect of topical glyceryl trinitrate cream on pain perception during intrauterine device insertion in multiparous women: A randomized double-blinded placebo-controlled study. J Gynecol Obstet Hum Reprod. 2019 Nov;48(9):715-718. doi: 10.1016/j.jogoh.2019.03.007. Epub 2019 Mar 18.
Clinical trial NCT03927651: ICG to Assess Ovarian Perfusion
Official title: Intraoperative Use of Intravenous Indocyanine Green (ICG) to Assess Ovarian Perfusion Using Infrared Imaging: A Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fibroid Uterus
Endometriosis
Uterus Myoma
Uterine Fibroid
Uterine Adenomyosis
Endometrial Cyst
Uterine Cyst
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To assess the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries during gynecologic surgery

Detailed description: The purpose of this study is to determine the feasibility of intravenous ICG administration to facilitate assessments of ovarian vascular perfusion. Historically, assessment of ovarian perfusion has been performed visually or via ultrasound with Doppler evaluation. In patients with ovarian endometriomas, evidence of ovarian interstitial microvascular injury has been demonstrated similarly by the presence of low flow and high RI. The use of ICG to evaluate ovarian perfusion specifically has not been reported. The use of ICG for intraoperative perfusion assessment of the ovary could provide more information about the health of the ovary and inform the surgical approach to ovarian pathology.

ICG will be injected intravenously to assess ovarian perfusion in the presence or absence (control) of pathology. Near infrared fluorescence imaging will be used to illuminate the ICG. The extent of perfusion will be determined using digital imaging software.

Eligibility criteria: Inclusion Criteria:

* Patients attending a preoperative visit at the Center for Comprehensive Gynecology who will undergo surgery.

Exclusion Criteria:

* Not able to comprehend and sign a written consent
* Patients with a history of allergy to iodides
* Patients history of renal failure or uremia, and those on dialysis

Primary outcomes:
measure: Assessment of ovarian perfusion after ICG administration via fluorescent imaging
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: 259 E Erie - Northwestern
state: Illinois
Study officials:
affiliation: Northwestern University
name: Magdy Milad, MD,MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04578951: Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range.
Official title: Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range and Followed for 2 Years.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Disease
Keywords: Knee
Arthroplasty
Replacement
Lead sponsor: FH ORTHO
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from participating hospitals will be enrolled as part of their clinical routine care

Brief summary: As part of Medical Devices CE marking regulatory process, an appropriate post-market clinical follow-up (PMCF) is required. This PMCF study is in the framework of CE mark renew of FHK® total knee prosthesis, it aims to answer specific questions related to safety and performance of the device, when used in accordance with the approved instructions for use.

This study is based on a quality of life self-assessment from the preoperative to postoperative phases and up to two years of follow-up.

Detailed description: The primary objective of this study is to evaluate the quality of life in patients operated with a FHK® total knee prosthesis up to 2 years of follow-up.

The secondary objectives are to evaluate the security and performance of the devices by gathering complications, revision rate of the devices (survival analysis) and functional score up to 2 years of follow-up.

Eligibility criteria: Inclusion Criteria:

* Subject implanted with FHK® prosthesis in one of the following indication according to the instructions for use: knee disorders; Aseptic condylar necrosis.
* Subject who received an information form and is willing to participate in the study.
* Adults subjects (≥18 years old).
* Access to an internet connection allowing to complete the questionnaires on the online platform

Exclusion Criteria:

* Contraindications described in the instructions for use
* Subject who is not able to express his/her non-opposition

Primary outcomes:
measure: Quality of life EQ-5D-5L score
timeFrame: 14 days preoperative ; 70 days post-op, 177 days post-op, 357 days post-op, 717 days post-op
Secondary outcomes:
measure: Survival rate
timeFrame: 2 years post-op
measure: Evolution of parameters describing pain, stability, knee mobility and patient autonomy
timeFrame: From the preoperative visit to 2 years postoperative.
measure: Rate of complications
timeFrame: All complications will be gathered during intervention and up to 2 years postoperatively.
Other outcomes:
Locations:
city: Laval
country: France
facility: Clinique du Maine
Study officials:
References:
Clinical trial NCT04651751: Exercise Habit & MPAC
Official title: Facilitating an Exercise Habit and Identity Via the Multi-Process Action Control Model- A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Public Health
Lead sponsor: University of Victoria
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The limitations of applying social cognitive models to understand physical activity (PA) have led to the emergence of several new PA models within the past decade. The Multi-Process Action Control (M-PAC) is a comprehensive PA model that proposes intention is established from outcome expectations, perceived capability, and opportunity, then the success of translating this to behavior depends on affective judgments and behavioral-regulation. Over time, M-PAC proposes that behavior is can become maintained through the formation of identity and habit. The purpose of this study was to investigate the trajectory of change of these M-PAC constructs across time in a randomized controlled trial. Participants (n=85) were inactive new gym members and were randomized into a control (n=41) or intervention (n=44) group. The intervention group attended a workshop and received a booster phone call follow-up at week four. Measures for both groups included accelerometry and M-PAC at baseline and eight week follow-up.


Eligibility criteria: Inclusion Criteria:

* adults 18-65
* new gym members
* exercising \< 150 minutes/week at a moderate to vigorous level

Exclusion Criteria:

* not affiliated with a gym or recreation center
* exercising \> 150 minutes/week at a moderate to vigorous level
* clinical health conditions (assessed by the PAR-Q)

Primary outcomes:
measure: GT3X+ Actigraph Activity Monitors (for measuring physical activity)
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: 1.Self-Report Behavioural Automaticity Index (self report, survey question
timeFrame: Baseline, week four, week eight
Other outcomes:
measure: Environmental Cues (self report, survey question)
timeFrame: Baseline, week four, week eight
measure: Temporal Consistency (self report, survey question)
timeFrame: Baseline, week four, week eight
Locations:
Study officials:
affiliation: University of Victoria
name: Ryan E Rhodes, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01410851: Pulses, Satiation, Food Intake and Blood Glucose
Official title: The Acute Effects of Pulse Consumption on Glycaemic Responses and Measures of Satiety and Satiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
First posted: 2011-08-05
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Pulses have the potential to be positioned as a food for body weight and metabolic control based on their composition, effects on rate of digestion and absorption of fat and carbohydrates, and effects on satiety. However, the role of individual pulses incorporated into a mixed meal on regulation of food intake, satiety and glycaemic control remains unclear. Therefore, the objective of our study was to determine the effects of ad libitum consumption of pulse meals (treatments) on food intake at an ad libitum pulse meal, food intake at an ad libitum pizza meal at four hours, subjective appetite and blood glucose.


Eligibility criteria: Inclusion Criteria:

* Healthy young males with BMI of 20-24.9 kg/m2

Exclusion Criteria:

* Females
* Smokers
* Breakfast skippers
* Individuals with diabetes or other metabolic diseases
* Those scoring ≥ 11 on an Eating Habit Questionnaire

Primary outcomes:
measure: Short-term energy intake
timeFrame: over 280 min
Secondary outcomes:
measure: Blood glucose and satiety
timeFrame: 20, 40, 60, 110, 140, 200, 260, 280, 300, 320 and 340 min
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Nutritional Sciences, University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: G. Harvey Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01466751: Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits
Official title: Neurobehavioral Intervention as a Novel Treatment Approach for Emotion-Regulatory Deficits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: Computerized neurobehavioral intervention
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 28
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: BASIC_SCIENCE

Brief summary: The present study will explore the effectiveness of a computer based neurobehavioral intervention in alleviating symptoms and improving emotion regulation in psychiatric populations. It will increase understanding of psychopathology at a neural-circuit level and aid development of new non-pharmacological treatment for emotion regulatory deficits.


Eligibility criteria: Inclusion Criteria:

* current anxiety or depression symptoms
* internet access

Exclusion Criteria:

* lifetime psychotic disorder, past-year substance dependence

Primary outcomes:
measure: Reaction Time to Facial Affect Identification During Emotional Conflict
timeFrame: Baseline, 3-month
measure: Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict
timeFrame: Baseline, 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, Department of Psychiatry and Behavioral Sciences
state: California
Study officials:
affiliation: Stanford University
name: Greg Fonzo, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06710951: Effect of Povidone-iodine 5% Vs 1% on the Ocular Surface in Intravitreal Injections of Anti-VEGF
Official title: Effect of Povidone-iodine 5% Vs 1% on the Ocular Surface As Antiseptic for Anti Vascular Endothelial Growth Factor Intravitreal Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Povidone-iodine
Pain
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 88
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical, prospective, randomized trial. Pre anti-VEGF intravitreal injection, with OCULUS Keratopgrapph 5M topograph, non invasive tear breaking time, bulbar redness, and Oxford scale with fluorescein staining were measured. During anti-VEGF injection, tetracaíne was use as anestetic. Povidone-iodine 1% or 5% was randomized as antiseptic. After anti-VEGF intravitreal injection, patients were examined again for tear bkreaking time, bulbar redness and Oxford sacle, plus pain 15 minutes after injection. Finally, two days after the injection, patients were interviwed by telephone about their pain.
Primary purpose: OTHER

Brief summary: Objective and subjective comparison between the use of povidone-iodine 1% vs 5% as antiseptic in patients that need anti-VEGF intravitreal injection

Detailed description: Randomized, prospective clinical trial. One group was intervened with povidone-iodine at 5% and the other at 1% as antiseptic for anti-VEGF intravitreal injection. Each patient was evaluated before and after the injection of anti-VEGF for tear break up time, bulbar redness and ocular surface satining with fluorescein. Pain perception was also evaluated 15 minutes after the injection and 48 hours after.

Eligibility criteria: Inclusion Criteria

* Having anti-VGEF intravitreal injection scheduled
* Informed consent signed

Exclusion Criteria

* Under 45 years
* Opacity that prevents ophthalmological evaluation and fixation
* Patients with severe dry eye
* Patients with signs of infection on the ocular surface
* Allergy to iodine
* Pregnancy

Primary outcomes:
measure: Tear breaking rupture
timeFrame: Change from baseline measured to 15 minutes post-injection
measure: Bulbar redness
timeFrame: Change from baseline measured to 15 minutes post-injection
Secondary outcomes:
measure: Oxford scale
timeFrame: Change from baseline measured to 15 minutes post-injection
measure: Pain analog scale
timeFrame: Change from baseline measured to 15 minutes post-injection
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociación para Evitar la Ceguera en México I.A.P.
Study officials:
affiliation: Asociación para Evitar la Ceguera en México I.A.P.
name: José Gerardo García-Aguirre
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00134251: Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Parallel Group Study Exploring Effects of SLV308 up to 42 mg/Day Administered as an Adjunctive Therapy to L-Dopa in Patients With Advanced Stage Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
adjunctive to L-dopa therapy
Advanced stage Parkinson's disease
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-08-24
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, randomized, double-blind, placebo controlled, parallel group study of a seven-week ascending dose period of SLV308 adjunctive to L-dopa treatment in patients with advanced stage Parkinson's disease (PD) and dose-dependent motor fluctuations. Patients (outpatients) will be randomized to one of three different treatment arms.


Eligibility criteria: Inclusion Criteria:

* Patients who have signed an informed consent; diagnosis of idiopathic PD.
* Presence of recognizable "on" and "off" stages
* Minimum hours of "off" time per day of 2.5 hours
* Able to keep diaries.

Exclusion Criteria:

* Unclear diagnosis or a suspicion of other parkinsonian syndromes
* Have undergone surgical treatment for PD
* History of non-response to L-dopa.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Site 16
city: Sofia
country: Bulgaria
facility: Site 11
city: Sofia
country: Bulgaria
facility: Site 12
city: Sofia
country: Bulgaria
facility: Site 13
city: Sofia
country: Bulgaria
facility: Site 14
city: Sofia
country: Bulgaria
facility: Site 15
city: Guardamangia
country: Malta
facility: Site 21
city: Belgrade
country: Serbia
facility: Site 31
city: Belgrade
country: Serbia
facility: Site 34
city: Nis
country: Serbia
facility: Site 33
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: