louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02397863: Epidiolex and Drug Resistant Epilepsy in Children
Official title: An Open Label, Multi-Center Study to Investigate the Safety of Cannabinoid (GWP42003-P) in Children With Medication Resistant Epilepsy
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Epilepsy
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: State of Georgia
First posted: 2015-03-25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy.

Detailed description: This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy. The study consists of an 8 week baseline, titration, and treatment of Epidiolex in a daily dosage up to 25 mg/kg/day, with an optional secondary titration schedule after 26 weeks of treatment up to a maximal daily dosage up to 50 m/kg/day until End of Treatment, followed by a taper-down period, and a safety follow up. Treatment will be provided for a total of 52 weeks with an interim analysis conducted 12 weeks after achieving maximal dose (either 25 mg/kg/day or optimal dose with regards to safety and tolerability) and at the end of 1 year of treatment with treatment extensions conducted beyond 52 weeks until such time as there is market authorization for Epidiolex, if Epidiolex becomes unavailable, or the study is terminated. Cessation of Epidiolex administration will be concluded with a taper period and follow-up visit 4 weeks after the taper.

Eligibility criteria: Inclusion Criteria:

* Patient should have history of trying at least four antiepileptic drugs (AEDs), including one trial of a combination of two concomitant drugs, without successful seizure control. Vagal nerve stimulation, RNS deep brain stimulation, or the ketogenic diet can be considered equivalent to a drug trial.
* Patient must be taking two or more AEDs at a dose which has been stable for at least four weeks.
* A State of Georgia resident.

Exclusion Criteria:

* Patient is diagnosed as having Dravet Syndrome or Lennox-Gastaut Syndrome and eligible for a GW Pharmaceutical-Sponsored Clinical Trial.
* Patients who have been part of a clinical trial involving another investigational product in the previous six months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
Study officials:
affiliation: Professor
name: Yong D Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01551563: Stavanger University Hospital Inflammatory Bowel Disease Trial
Official title: Management of Inflammatory Bowel Disease in the Stavanger Area - a Prospective Evaluation of Standardized Treatment Regimens on Disease Outcome With Focus on Mucosal Healing and Associations to Fatigue
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IBD
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2012-03-12
Enrollment: 700
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newly diagnosed IBD patients (Crohns and Ulcerative colitis) within Stavanger Univ Hospital catchment area

Brief summary: The study aims at studying the outcomes of a protocol-based handling of newly diagnosed Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a descriptive study and no hypothesis is predefined.

Cytokine studies, QoL and fatigue assessment will be included for hypothesis-generating purposes.

Detailed description: none considered needed

Eligibility criteria: Inclusion Criteria:

* newly diagnosed IBD

Exclusion Criteria:

* previous IBD with specific treatment within 10 year
* inability to consent
* inability to adhere to treatment protocol

Primary outcomes:
measure: Clinical efficacy of IBD drug therapy
timeFrame: 5 years
Secondary outcomes:
measure: Fatigue in patients with coeliac disease - substudy
timeFrame: 1 year
measure: Fatigue in IBD
timeFrame: 5 years
measure: IBD and the intestinal microbiome
timeFrame: 5 years
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: SUS
Study officials:
affiliation: Helse Stavanger HF
name: Tore Grimstad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grimstad T, Skoie IM, Doerner J, Isaksen K, Karlsen L, Aabakken L, Omdal R, Putterman C. TWEAK is not elevated in patients with newly diagnosed inflammatory bowel disease. Scand J Gastroenterol. 2017 Apr;52(4):420-424. doi: 10.1080/00365521.2016.1273382. Epub 2016 Dec 31.
citation: Grimstad T, Norheim KB, Isaksen K, Leitao K, Hetta AK, Carlsen A, Karlsen LN, Skoie IM, Goransson L, Harboe E, Aabakken L, Omdal R. Fatigue in Newly Diagnosed Inflammatory Bowel Disease. J Crohns Colitis. 2015 Sep;9(9):725-30. doi: 10.1093/ecco-jcc/jjv091. Epub 2015 May 19.
Clinical trial NCT00713063: Behavioral Exercise Intervention for Smoking Cessation
Official title: Behavioral Exercise Intervention for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nicotine Dependence
Keywords: smoking cessation
exercise
physical activity
health education
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-07-11
Enrollment: 61
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: The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for smokers interested in quitting smoking. We expect that this project will contribute much needed knowledge about the role of aerobic exercise in smoking cessation. If the efficacy of moderate-intensity, aerobic exercise for smoking can be established, smokers may have a valuable adjunct to more traditional smoking cessation approaches.


Eligibility criteria: Inclusion Criteria:

1. are between 18 and 65 years of age
2. are current smokers (i.e., smoking at least 10 cigarettes per day)
3. are sedentary, i.e., have not participated regularly in aerobic physical exercise (for at least 20 minutes per day, 3 days per week) for the past six months.

Exclusion Criteria:

1. current DSM-IV Axis I psychiatric disorder as assessed by SCID-NP
2. Substance abuse or dependence (excluding nicotine dependence) within the past 6 months
3. lifetime DSM-IV diagnosis of a bipolar disorder as assessed by the SCID-NP
4. lifetime history of a psychotic disorder or current psychotic symptoms as assessed by the SCID-NP
5. current suicidality or homicidality
6. marked organic impairment
7. physical disabilities or medical problems (such as a history of diabetes, hypertension, seizure disorder, coronary heart disease, valvular heart disease, and pulmonary disease) or use of medications (such as beta blockers) that would prevent or hinder participation in a program of moderate intensity exercise
8. current pregnancy of intent to become pregnant during the next 12 weeks, and i) current use of any pharmacotherapy, including transdermal nicotine replacement, for smoking cessation

Primary outcomes:
measure: Self-reported smoking abstinence via Timeline Followback (TLFB)
timeFrame: 12-months
measure: Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Butler Hospital
name: Ana Abrantes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06590363: The Effect of Music on Anxiety in the Appointment Period
Official title: The Effect of Musical Intervention in Anxiety on Patients and Doctors in the Appointment Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: music
anxiety
heart rate
blood pressure
appointment
Lead sponsor: Centro Hospitalar e Universitário de Coimbra, E.P.E.
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 70
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: The goal of this randomized clinical trial is to learn if musical intervention can reduce anxiety on patients and doctors in the appointment period. The main questions it aims to answer are:

Can music reduce the psychological symptoms of anxiety at the end of the appointment? Can music reduce heart rate and blood pressure at the end of the appointment?

Researchers will compare if the presence of zen music during the appointment influences anxiety levels.

Participants in the intervention group will listen to music during the appointment. Those in the control group will not have music in the office during the appointment.


Eligibility criteria: Inclusion Criteria:

* scheduled appointment;
* agree to participate in the clinical trial.

Exclusion Criteria:

* 17 years or younger;
* deaf;
* illiterate.

Primary outcomes:
measure: Anxiety
timeFrame: 16 weeks
Secondary outcomes:
measure: Heart rate
timeFrame: 16 weeks
measure: Blood Pressure
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Cátia Valesca Nunes Solis
Study officials:
References:
Clinical trial NCT05599763: Multicenter, National, Observational, Prospective, Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash
Official title: Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaper Rash
Lead sponsor: Cooperation Pharmaceutique Francaise
Sponsor class: INDUSTRY
Collaborators: name: Clin-Experts
First posted: 2022-10-31
Enrollment: 67
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in consultation by French general practitioners and pediatricians

Brief summary: This study is being conducted to provide updated clinical data on safety and performance (demonstrated previously for CE marking under the Medical Devices Directive) Cooper Aqueous Eosin 2%. This is an observational study conducted under real-life conditions and as part of post-marketing surveillance activity for a device that has been on the market for a long time and a well-established technology, in accordance with the Medical Devices Regulations 2017 /745 (MDR) and MDCG 2020-6 guidelines.

The study will be a multicenter, national, observational, prospective study, with a 7-day follow-up (+/- 2 day). 60 patients are scheduled.


Eligibility criteria: Inclusion Criteria:

* Children under 24 months
* With diaper rash for which a prescription for 2% aqueous eosin in a 50 ml vial is made
* SSDDS score \>= 3/6
* Not requiring hospitalization
* Written consent of one of the parents
* Affiliated with social security
* Acceptance of one of the parents to participate in a visit on day 7 in the office or, in case of impossibility, with video/internet consultation or with consultation by phone and sending a photo in this case by the parent(s).

Exclusion Criteria:

* Antibiotic therapy in progress or prescribed on day 0, or other local therapeutic topicals prescribed on day 0
* Children with wounds or likely to be allergic to 2% aqueous eosin or to one of the components of 2% aqueous eosin.
* Ongoing diarrhoea (change in the consistency of stools (loose or watery) and / or an increase in the number (≥ 3 stools / day).

Primary outcomes:
measure: Percentage of patients with an SSDDS score < 3/6 or an improvement of at least 2 points
timeFrame: at day 7 +-2 days
Secondary outcomes:
measure: Percentage of patients completely cured
timeFrame: at day 7 +/-2 days
measure: Healing time according to parent
timeFrame: up to 9 days
measure: Change of the SSDDS score between day 0 and day 7
timeFrame: at day 7 +/-2 days
measure: Change in associated signs between day 0 and day 7
timeFrame: at day 7 +/-2 days
measure: Assessment of tolerance
timeFrame: at day 7 +/-2 days
measure: Assessment of compliance
timeFrame: at day 7 +/-2 days
Other outcomes:
Locations:
city: Multiple Locations
country: France
facility: Multiple locations
Study officials:
affiliation: CHU DIJON
name: Frédéric HUET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06655363: Anatomo-radiological Study of the Ankle's Lateral Ligament
Official title: Anatomo-radiological Study of the Ankle's Lateral Ligament
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Injuries and Disorders
Keywords: Ankle
Subtalar instability
MRI
Anatomy
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing routine follow-up MRI one year after ankle ligament surgery will be included.

Brief summary: Subtalar instability is found in 30% of cases following a severe ankle sprain. Treatment is conditioned by subtalar involvement, so detection is essential. There is no consensus on the ligament anatomy of the subtalar region, making precise diagnosis of subtalar ligament damage difficult. The aim of this study is to provide a detailed description of the anatomy of the subtalar ligaments of interest, followed by a detailed radiological description (MRI).


Eligibility criteria: Inclusion Criteria:

* Adult patients with no history of sprain on studied ankle

Exclusion Criteria:

* Sprain on studied ankle

Primary outcomes:
measure: Cervical ligament length
timeFrame: Day : 1
Secondary outcomes:
measure: Calcaneo fibular ligament length
timeFrame: Day : 1
measure: Cervical ligament width
timeFrame: Day : 1
measure: Calcaneo fibular ligament width
timeFrame: Day : 1
measure: Calcaneo fibular ligament thickness
timeFrame: Day : 1
measure: Cervical ligament thickness
timeFrame: Day : 1
measure: Interosseus talo-calcaneal ligament length
timeFrame: Day : 1
measure: Interosseus talo-calcaneal ligament width
timeFrame: Day : 1
measure: Interosseus talo-calcaneal ligament thickness
timeFrame: Day : 1
measure: Talo-fibular ligament length
timeFrame: Day : 1
measure: Talo-fibular ligament width
timeFrame: Day : 1
measure: Talo-fibular ligament thickness
timeFrame: Day : 1
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Pierre-Henri VERMOREL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05112263: Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis
Official title: Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis: An Open Label Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
Collaborators: name: All India Institute of Medical Sciences
First posted: 2021-11-08
Enrollment: 96
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: This randomised trial plans to compare oral tofacitinib with intravenous cyclosporine in patients with acute severe ulcerative colitis who have failed to respond to intravenous steroids


Eligibility criteria: Inclusion Criteria:

Patients admitted with Acute severe ulcerative colitis as defined by Modified Truelove and Witts Criteria WITH Failure to respond to intravenous steroids (Hydrocortisone 100 mg IV QID OR IV Methylprednisolone 60 mg IV OD) as defined by

* Day 3 non-response as per Oxford criteria (stool frequency of \> 8/day, OR stool frequency between 3-8 with CRP \> 45 mg/L PLUS
* Ongoing activity as defined by Partial Mayo Score of \> 3 (rectal bleeding sub-score of \>1)
* Decision to start second line therapy (within 5-7 days of starting intravenous steroids)

Exclusion Criteria:

* Age \<18, Age \> 65 years

  * E1 disease (involvement distal to rectosigmoid junction only)
  * Crohn's disease
  * Contraindication to intravenous cyclosporine or oral tofacitinib

    * Renal failure, uncontrolled hypertension, seizure disorder,and uncorrected hypomagnesemia (\<1.5 mg/L)
    * Previous thrombosis, or prothrombotic state, on oral contraceptive, history of herpes zoster, active TB, active hepatitis, past opportunistic infections, h/o diverticulitis, Age \>50 plus at least one cardiac risk factor
  * Patient wants treatment with intravenous infliximab or wants surgery
  * Underlying sepsis or active infection (Enteric infections, Clostridium difficile, active hepatitis B or C, Tuberculosis, zoster, CMV disease)
  * Toxic megacolon, previous dysplasia or any indication of immediate surgery
  * Known malignancy
  * Pregnancy or Lactation
  * Unwilling to provide consent or for follow-up

Primary outcomes:
measure: Treatment failure
timeFrame: 14 weeks
Secondary outcomes:
measure: Clinical response
timeFrame: 7 days
measure: Absence of steroid free remission
timeFrame: day 98
measure: Colectomy free survival
timeFrame: 98 days
measure: Time to clinical response
timeFrame: 98 days
measure: Endoscopic healing
timeFrame: Day 98
measure: Serious adverse effects
timeFrame: 98 days
Other outcomes:
Locations:
Study officials:
affiliation: PGIMER Chandigarh
name: Vishal Sharma
role: PRINCIPAL_INVESTIGATOR
affiliation: AIIMS Delhi
name: Vineet Ahuja
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00082563: Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum
Official title: A Phase II, Randomized, Comparative Trial Of Azithromycin In Combination With Chloroquine Versus Chloroquine In The Eradication Of Asymptomatic Plasmodium Falciparum Infection In Semi-Immune Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malaria, Falciparum
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-05-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Azithromycin in combination with chloroquine is superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in asymptomatic, semi-immune adults in Western Kenya.

Detailed description: The trial was terminated prematurely 9 November 2004 due to the inability to recruit the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Eligibility criteria: Inclusion Criteria:

* Healthy adult: male or female
* Asymptomatic mono-infection with P. falciparum parasitemia with a parasite density of 1000 - 30,000 parasites/Î¼L
* Age 18 years to 60 years
* Willingness to sign and ability to understand consent form
* Willingness and ability to return for scheduled follow up visits

Exclusion Criteria:

* Mixed malaria infection by Giemsa smear
* History of allergy to or hypersensitivity to chloroquine, Azithromycin or other macrolides (e.g. erythromycin, clarithromycin)
* Any of the following: a.) Antimalarial therapy administered in the past 4 weeks, including quinine therapy or an artemisinin derivative; or b.) An antibacterial with known antimalarial activity (including, erythromycin, doxycycline, clindamycin, cotrimoxazole) within one week prior to enrollment into the study
* Fever, history of fever in past 48 hours, or signs/symptoms of malaria (including acute or subacute headache, nausea, or vomiting)
* Inability to swallow oral medication
* Laboratory evidence or history of significant cardiovascular, liver, hematologic or renal functional abnormality
* Any situation which could prevent the patient from returning to follow up visits
* Pregnancy or breast feeding
* Any other concurrent illness that may confound the result
* Any other condition or circumstance that in the opinion of the Investigator may pose a threat to the study participant or study

Primary outcomes:
measure: Parasite clearance
Secondary outcomes:
measure: tolerability
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT07011563: Prepping for The Talk: Helping Trusted Adults and Youth Talk About Sexual Health
Official title: Prepping for The Talk: Helping Trusted Adults and Youth Talk About Sexual Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
Sexual Health
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-06-09
Enrollment: 40
Sex: MALE
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to help young people talk to trusted adults (including their parents, but also other adults) about sexual health more openly and honestly- including how to prevent sexually transmitted diseases like HIV - while also respecting a young person's right to privacy. If youth don't have a parent they can talk to about sexual health, we want to help them find a trusted adult to talk to. We also want to help youth take control of their own health by learning about different ways to protect their health.


Eligibility criteria: Inclusion Criteria:

* Age 14-17
* Assigned male
* Oral OR anal sex with an assigned male
* Live in the United States
* English-speaking

Exclusion Criteria:

* None

Primary outcomes:
measure: Sexual health communication scale score - youth
timeFrame: 4 weeks
measure: Sexual health communication scale score - parent
timeFrame: 4 weeks
Secondary outcomes:
measure: PrEP uptake
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Brown University Health
name: Jack Rusley, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: