louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04232046: Trigger Point Massage in Chronic Tension Headache
Official title: Efficacy of Trigger Points Massage in Severity of Chronic Tension Headache:An Unmasked, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-Type Headache
Keywords: Massage
Trigger point
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case and control group
Primary purpose: TREATMENT

Brief summary: Patients with IHS criteria of chronic tension headache , considering inclusion and exclusion criteria, enrolled to this study. They will be randomized to intervention or control group by block randomization method, then treat by standard drug( nortriptyline 10 mg daily) or trigger point massage.

They report severity, frequency, duration of headaches and number of analgesic drugs in diary during week 1 and week 4. Then data based on dairy will be analysis.


Eligibility criteria: Inclusion Criteria:

1. Chronic tension type headache according to IHS criteria
2. Finding painful trigger point in physical examination
3. no contraindication for massage
4. no prophylactic treatment
5. written inform consent

Exclusion Criteria:

1. Dementia or severe cognitive impairment
2. Under Treatment with drugs with prophylactic effect
3. History of RA or Cervicocephalic fracture or other skeletal deformity
4. Other complementary treatment

Primary outcomes:
measure: Headache severity change
timeFrame: Mean Visual Analogue Scale sore change in week 4 from the baseline
Secondary outcomes:
measure: Headache frequency change
timeFrame: Change in number of attacks in week 4 from the base line
measure: Headache duration change
timeFrame: Change in Time duration in week 4 from the baseline
measure: Number of analgesic change
timeFrame: Change in Number of analgesic drugs used in week 4 from the baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04967846: Social Media Effects on Mental Health
Official title: How Do We Resolve the Social Dilemma? Facebook Features Use as a Moderator of Mental Health.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health Issue
Mental Health Wellness 1
Mental Health Wellness 2
Social Media Addiction
Internet Addiction
Keywords: Social Media
Facebook
Mental Health
Wellbeing
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 608
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruiting a representative sample of 740 people on the crowdsourcing platform Amazon Mechanical Turk (MTurk).

Brief summary: In the last decade, research on social media and mental health has produced mixed results. Overall, the current findings suggest that the negative effects on mental health are exacerbated by longer and more frequent social media usage, whereas the positive effects are bolstered when social media is used to connect with other people.

With the largest number of global users, Facebook is the most frequently studied social media network. Over the past few years, the increasing concerns about the risks associated with Facebook have even translated to wider pop culture conversations, as exemplified by the 2020 documentary The Social Dilemma. In response, Facebook has rolled out a series of features supposed to mitigate these risks and encourage responsible social media usage. These features include activity trackers and reminders, unfollow and snooze buttons, and data sharing regulators. Currently, there is no research done to address whether (1) these features are used at all, and (2) whether they are successful in moderating the negative mental health consequences of Facebook usage.

This study seeks to address the gap in literature through a survey done on the crowdsourcing platform Amazon Mechanical Turk (MTurk).


Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers, aged 21 and above
* English proficiency
* Facebook users

Exclusion Criteria

* Participants below 21 years old
* Non-Facebook users

Primary outcomes:
measure: Mental Health Scores
timeFrame: Once during the survey.
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yale NUS
Study officials:
affiliation: Yale-NUS College
name: Tamara Barsova
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barsova T, Cheong ZG, Mak AR, Liu JC. Predicting Psychological Symptoms When Facebook's Digital Well-being Features Are Used: Cross-sectional Survey Study. JMIR Form Res. 2022 Aug 29;6(8):e39387. doi: 10.2196/39387.
Clinical trial NCT03103646: Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women
Official title: Interventional, Open-label, One-sequence Crossover Study Evaluating the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics, Safety and Tolerability of Lu AF35700 in Healthy Young Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cytochrome P450 Interaction
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2017-04-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Men, aged ≥18 and ≤55 years. body weight ≥50 kg
* women, aged ≥18 and ≤45 years, body weight ≥50 kg
* Good general health as assessed using detailed medical history, laboratory tests, and physical examination
* Known CYP2D6 and CYP2C19 genotype

Exclusion Criteria:

* Pregnant or lactating
* Subject has previously been dosed with Lu AF35700

Other protocol defined inclusion and exclusion criteria may apply

Primary outcomes:
measure: AUC(0-inf)
timeFrame: Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdose
measure: Cmax
timeFrame: 0-24 hours postdose (Day 1 and day 32)
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance - Dallas
state: Texas
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit Ltd
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT04294446: Post-market Study of the Biodesign Hernia Graft
Official title: Post-market Study of the Biodesign® Hernia Graft
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventral Hernia
Lead sponsor: Cook Biotech Incorporated
Sponsor class: INDUSTRY
First posted: 2020-03-04
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who meet all of the inclusion criteria and none of the exclusion criteria will be invited to participate in this study.

Brief summary: The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.

Detailed description: This multicenter, open-label, prospective clinical study will evaluate the performance of the Biodesign Hernia Graft to reinforce soft tissues during ventral hernia repair.

This post-market study will enroll up to 95 patients at up to 10 clinical sites. Each clinical site will be limited to a maximum of 50 patients to ensure a variety of patients and surgical techniques are represented. There is no minimum enrollment number per site.

This study has been designed as a multicenter, open-label, prospective study to collect data on the performance of the Biodesign Hernia Graft. The inclusion and exclusion criteria for this study have been selected based on the instructions outlined in the IFU so that the results from this study can provide data on the real-world use of the device.

Eligibility criteria: Inclusion Criteria:

1. Primary or recurrent ventral hernia in need of surgical repair utilizing a Biodesign Hernia Graft

Exclusion Criteria:

1. Known sensitivity to porcine material

   For the study, the following patients will also be excluded:
2. Age \< 18 years
3. Unable or unwilling to provide informed consent
4. Life expectancy of less than one year from the date of the index procedure
5. Patients will be excluded from the study if they never receive a Biodesign Hernia Graft during their index procedure.

Primary outcomes:
measure: Hernia recurrence
timeFrame: 1-year
Secondary outcomes:
measure: Device-, procedure-, and hernia-related adverse event rates
timeFrame: 2-year
measure: Hernia recurrence rate through 2-year follow-up
timeFrame: 2-year
measure: Operative times
timeFrame: 2-year
measure: Hospital stay
timeFrame: 2-year
measure: Hospitalization times for related Serious Adverse Events (SAEs)
timeFrame: 2-year
measure: Patient-reported quality of life: questionaire
timeFrame: 2-year
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Hospital
state: Nova Scotia
Study officials:
References:
Clinical trial NCT05139446: Reproductive Outcomes Following Uterine Septum Resection
Official title: Reproductive Outcomes Following Uterine Septum Resection- a Bicentric Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Septum
Keywords: uterine septum
Hysteroscopic septum resection
Metroplasty
Subfertility
Infertility
Preterm delivery
Spontaneous abortion
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major female (≥18 years old) being an operating patient at the strabourg university hospital or Bicetre Hospital between January 2009 and December 2019.

Brief summary: Nowadays, there is little data to validate the performance of surgical hysteroscopies in the case of septate uterus, particularly in the case of incidental discoveries. Clinical practice and the experience of teams leads to propose this procedure, but strong evidence for this recommendation is lacking and there is an urgent need for solid data.

A recent randomized trial contradicts this recommendation, but the methodology is questionable on several points.

Investigators wished to associate 2 reference centers with current practice and expertise on this procedure in order to have a cohort of many patients and to have more powerful results.) Investigators purpose a retrospective observational data-based study. The aim is to describe the profile of patients with a partitioned uterus in terms of obstetrical history and to study the consequences of uterine partition resection in terms of obstetrical prognosis (live births, at term, number of miscarriages or premature births).

The aim of this study is to take into account the evaluation of the surgical hysteroscopy gesture by postoperative imaging with in particular the indication of a resection in several stages in case of residual postoperative septum.


Eligibility criteria: Inclusion criteria:

Major female (≥18 years old) To be an operating patient at the strabourg university hospital or Bicetre Hospital between January 2009 and December 2019.

Exclusion criteria:

Particular clinical forms of the disease, (associated enlargement metroplasties, other uterine maformations) Minor patients, patients under guardianship

Primary outcomes:
measure: Retrospective study of the uterine septum resection technique by operative hysteroscopy
timeFrame: Files analysed retrospectively from January 01, 2009 to December 31, 2019 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT03262246: Cerebral Infarction and White Substance in Angiopathy Cerebral Amyloid
Official title: Cerebral Infarction and White Substance in Angiopathy Cerebral Amyloid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyloid Angiopathy
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 126
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Investigators select medical report of hospitalized patient between 2011/01/01 and 2015/12/31 in CAEN hospital and Paris St Joseph hospital ; these had an MRI for cerebral haemorrhage.

Brief summary: The cerebral amyloïd angiopathy ( AAC) is a disease characterized by deposits of beta-amyloid peptids in the walls of the arteries of young and average calibre of the brain and the leptomeninx. The incidence of the AAC increases strongly with the age and represents a major cause of spontaneous brain haemorrhage to people over 60. The main demonstration is the lobar brain haemorrhage, the other ones are bleedings under arachnoid cortical and microbleedings leading to cognitive decline.

Anatomical studies reported the presence of cortical infarcts in patients having amyloïd deposits suggesting an association between asymptomatic cortical cerebral infarcts and AAC.

However prevalence and meaning of these infarcts in patients having an AAC remain badly known because of studies on low number of patients and the rarity of radiological analyses of these infarcts .A better knowledge of these asymptomatic cortical infarcts would allow to dread better cognitive disorders(confusions) presented by these patients, and to develop preventive strategies.

Besides, the risk factors of severity of the AAC are little studied.


Eligibility criteria: Inclusion Criteria:

* age\>55
* hospitalized in CAEN hospital and Paris St Joseph Hospital between 1st january 2011 and 31 december 2015 for cerebral haemorrhage with MRI images diagnosing cerebral amyloid angiopathy.

Exclusion Criteria:

* Insufficient MRI images quality without FLAI sequence, T2 GRE
* disease with same radiologic and clinical signs that cerebral amyloid angiopathy.

Primary outcomes:
measure: number of patient with cerebral infarction and associated factors in a cohort of cerebral amyloid angiopathy patients
timeFrame: 1day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: HODEL Jérome, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06045546: A (5-5-5-8) Technique for Laparoscopic Cholecystectomy
Official title: A (5-5-5-8) Technique for Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cholecystitis; Gallstone
Cholecystolithiasis
Cholecystitis, Chronic
Lead sponsor: ClinAmygate
Sponsor class: OTHER
Collaborators: name: Aswan University Hospital
First posted: 2023-09-21
Enrollment: 524
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: The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.

Detailed description: More than 50 different LC procedures are described in the literature, mostly as a result of changes made by surgeons to enhance cosmetic and postoperative results. Some adjustments include port size and/or number reductions relative to conventional LC usage. Each of these methods has benefits and drawbacks, and each one is appropriate for usage in particular circumstances.

The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.

The study has two analyses:

1. at 6 month follow up
2. at 24 months follow up

Eligibility criteria: Inclusion Criteria:

* Aged \> 18 years
* Patients eligible for LC during the study period

Exclusion Criteria:

* refused to participate

Primary outcomes:
measure: Duration of the operation
timeFrame: 1 hour
measure: Number of participants with Conversion to open surgery
timeFrame: 1 hour
measure: Incidence of intra operative visceral injury
timeFrame: 2 hours
measure: intra operative amount of blood loss
timeFrame: 2 hours
measure: incidence of intra operative complications
timeFrame: 2 hours
Secondary outcomes:
measure: post operative stay
timeFrame: 1 week
measure: incidence of port site infection
timeFrame: 1 month
measure: Incidence of port site hernia
timeFrame: 6 months
measure: Incidence of port site hernia
timeFrame: 12 months
measure: Incidence of port site hernia
timeFrame: 24 months
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan University Hospital
name: Mohie El-Din M Madani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05320146: A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
Official title: A Phase 1b, Open-Label Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Adult Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonalcoholic Steatohepatitis (NASH)
Keywords: Nonalcoholic Steatohepatitis
NASH
Nonalcoholic Fatty Liver Disease
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have previously enrolled in CORT118335-860 or in CORT118335-861 and have received at least one dose of miricorilant.

Brief summary: This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)

Detailed description: This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH).

All patients who participated in the current study (CORT118335-861) or the Corcept Phase 2a NASH study (CORT118335-860), and who received at least one dose of miricorilant will be eligible for participation in an observational follow-up study; this includes patients who either terminated early or are study completers.

Eligibility criteria: Inclusion Criteria:

* Have participated in either Study CORT118335-861 (current study) or Study CORT118335-860 (Corcept Phase 2a NASH study) and received at least one dose of miricorilant; this includes patients who terminated early from the study or completed the study.
* Have not participated in any other clinical trial following study completion in either Study CORT118335-861 or Study CORT118335-860.

Primary outcomes:
measure: Change in liver-fat content assessed by MRI-PDFF after the last dose of study drug.
timeFrame: Baseline Day 1 up to Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Site 207
state: Arizona
city: Tucson
country: United States
facility: Site 209
state: Arizona
city: Panorama City
country: United States
facility: Site 214
state: California
city: Santa Ana
country: United States
facility: Site 233
state: California
city: Austin
country: United States
facility: Site 211
state: Texas
city: Edinburg
country: United States
facility: Site 213
state: Texas
city: Houston
country: United States
facility: 305
state: Texas
city: San Antonio
country: United States
facility: Site 212
state: Texas
city: Seattle
country: United States
facility: 226
state: Washington
Study officials:
affiliation: Corcept Therapeutics
name: Kavita Juneja, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03364946: High Flow Therapy in ICUs Across Ibero America
Official title: High Flow Nasal Cannula Technique in Iberoamerica
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasal High Flow Therapy
Intensive Care Unit
Ventilatory Failure
Hypoxia
Hypercapnic Respiratory Failure
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years old, admitted to an ICU in the reference centers in Iberoamerica, requiring the use of high nasal flow therapy

Brief summary: The study aims to describe the use of Nasal High Flow (NHF) in the intensive care units of participating centers in Iberoamerica. It will describe the indications for the use, the clinical outcome of patients , and the therapeutic failure of NHF therapy in patients staying in an intensive care unit in the participant centers in Iberoamerica.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Admitted to medical or surgical ICU
* Requirement of high nasal flow therapy

Exclusion Criteria:

* Post-extubation failure
* Patient unable to protect airway
* Diagnosed shock
* Glasgow equal or under 8

Primary outcomes:
measure: Hypoxemia
timeFrame: 15 days
measure: Tachypnea
timeFrame: 15 days
measure: Hypercapnia
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Fundación Santa Fe de Bogotá
state: Bogotá
city: Nariño
country: Colombia
facility: Hospital Departamental de Nariño
state: Pasto
city: Ibague
country: Colombia
facility: Medicina Intensiva del Tolima
state: Tolima
city: Bogota
country: Colombia
facility: Clinica Reina Sofia
city: Santo Domingo
country: Dominican Republic
facility: Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavarez (INCART)
city: Ciudad de mexico
country: Mexico
facility: Fundación Medica Sur
state: Ciudad De México
city: Barcelona
country: Spain
facility: Hospital del Mar - Parc de Salut Mar
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
Study officials:
affiliation: Fundación Santa Fe de Bogotá
name: Leopoldo E Ferrer, MD
role: PRINCIPAL_INVESTIGATOR
References: