louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04707911: Social Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents
Official title: Social Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaping
Keywords: Nicotine Dependence
Social Media
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
name: HopeLab Foundation
name: Rescue Agency
First posted: 2021-01-13
Enrollment: 500
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Social media based intervention to support teens in their efforts to quit vaping.

Detailed description: This study is a randomized controlled trial of a social media intervention to support teens in their efforts to quit vaping.

Eligibility criteria: Inclusion Criteria:

1. English literacy
2. Age between 13-21 years
3. Indicate they use social media "most" (\>= 4) days per week
4. Have vaped at least once per week in the past 30 days (90 percent of participants)
5. Access to a computer or mobile phone with photo capability to verify abstinence from vaping
6. Indicate they are considering quitting or are interested in quitting with the next 6 months or within the next 30 days
7. Currently reside in California

Exclusion Criteria:

1. No English literacy
2. Age under 13 or over 21
3. Insufficient social media use (3 or fewer days per week)
4. Have not vaped at least once per week in past 30 days
5. No access to computer or mobile phone with photo capability to verify abstinence from vaping
6. Not considering or interested in quitting vaping in the next 30 days or 6 months;
7. Not a California resident

Primary outcomes:
measure: Point Prevalent Abstinence (PPA) from vaping
timeFrame: 1 month
measure: Point Prevalent Abstinence (PPA) from vaping
timeFrame: 3 months
measure: Point Prevalent Abstinence (PPA) from vaping
timeFrame: 6 months
Secondary outcomes:
measure: Change in the number of participants with reduction in vaping
timeFrame: Up to 6 months
measure: Change in the number of vape quit attempts
timeFrame: Up to 6 months
measure: Number of participants with at least 1 quit attempt
timeFrame: Up to 6 months
measure: Change in response on Stages of Change Questionnaire
timeFrame: Up to 6 months
measure: Change in the score on the Thoughts About Abstinence (TAA) Questionnaire
timeFrame: Up to 6 months
measure: Change in the scores on the Ways of Quitting questionnaire (WOQ)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Pamela Ling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05933811: Contralateral Testicular Volume in Unilateral Impalpable Testis
Official title: Does the Contralateral Testicular Volume Decide the Need for Diagnostic Laparoscopy in Cases of Unilateral Impalpable Undescended Testis?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric ALL
Keywords: Impalpable testis
volume
Ultrasound
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2023-07-06
Enrollment: 76
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective interventional study aimed at the preoperative sonographic estimation of the testicular volume of the normal side in case of contralateral impalpable maldescended testis in order to predict the condition of the diseased side and hence the need for diagnostic laparoscopy.

Detailed description: Purpose: This study aimed at the evaluation of the value of the estimated volume of a normal testis to predict the status of its contralateral impalpable side and hence decide the importance of laparoscopic exploration. Material \& methods: Patients with unilateral impalpable maldescended testis - as confirmed by clinical and sonographic examination- were enrolled in this prospective interventional study between November 2018 and August 2022 at Elshatby University Hospital, Faculty of Medicine, Alexandria University. The volume and three-dimensional diameter of the normal contralateral testis were measured by the pre-operative US using the formula: Volume = L x W x H x π/6, where L is the length, W is the width, H is the height, and was correlated with the intra-operative laparoscopic findings.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients with unilateral impalpable maldescended testis

Exclusion Criteria:

* Patients with bilateral impalpable maldescended testis and those with post-operative ascended testis

Primary outcomes:
measure: The size of the impalpable testis as examined by laparoscopy
timeFrame: Intraoperative
measure: The presence of testicular vessels of the impalpable testis as examined by laparoscopy
timeFrame: Intraoperative
measure: The presence of the vas deference of the impalpable testis as examined by laparoscopy
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Pediatric Surgery department
name: Ahmed Elrouby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03443011: Diagnostics in Diverticulitis (DIDit)
Official title: Diagnostics in Diverticulitis (DIDit)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diverticulitis
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Centrallasarettet Västerås
name: Mora Hospital, Landstinget Dalarna
First posted: 2018-02-22
Enrollment: 149
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study focuses on if low dose CT without intravenous contrast has a high enough specificity and sensitivity for acute diverticulitis that it can be used as the primary diagnostic method instead of a full dose CT with intravenous contrast which is the standard method in Sweden.

Detailed description: Patients will be recruited from the emergency departments in Mora and Vastmanland hospitals. All patients over the age of 50 with clinically suspected acute diverticulitis that meet inclusions criterium will be asked for participation. A Clinical examination and blood samples will be drawn.

Subjects will be sent to the radiology department where they will undergo computed tomography (CT) of the abdomen. The CT protocol consists of a low dose non contrast enhanced CT followed by a normal dose CT with intravenous contrast. This is needed as randomization of patients is not possible due to the fact that the Clinical diagnosis of diverticulitis is difficult and unreliable. This would lead to the situation that we would not know if a participant in the low dose CT Group has diverticulitis which was not seen with the low dose protocol or if the patient did not have diverticulitis.

The radiologist on call will examine the full dose CT examination and write a report as routine. At a later date Three blinded radiologists will examine first all low dose CT examinations and grade them according to our CT protocol. At a later date the radiologists will evaluate all full dose CT examinations using the same CT protocol.

Findings will then be compared between the two different CT methods and sensitivity and specificity for low dose CT will be calculated.

Eligibility criteria: Inclusion Criteria:

* Over the age of 50
* Clinically suspected acute diverticulitis
* Low abdominal pain
* WBC over 10 x 109/L or raised C-reactive protein levels 25 mg/L

Exclusion Criteria:

* Pregnancy
* Previous allergy to intravenous contrast
* Renal failure or other reasons that the patient cannot undergo CT with iv contrast
* Unable to give informed consent
* Dementia
* Language barrier

Primary outcomes:
measure: Presence of diverticulitis on low dose CT and/or full dose CT
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Vasteras
country: Sweden
facility: Region Vastmanland Hospital
state: Vastmanland
Study officials:
affiliation: Center for Clinical Reasearch Vasteras
name: Kenneth Smedh, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00185328: Efficacy and Tolerability of Angeliq in Thai Women
Official title: A Multi-Center, Open-Label, Non-Comparative Study Investigating the Efficacy and Tolerability of Angeliq® in Postmenopausal Thai Women With Vasomotor Symptoms Over Three 28-Day Treatment Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postmenopause
Keywords: Postmenopause
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 55
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with hot flushes

Exclusion Criteria:

* Women with a contraindication for Hormone Replacement Therapy (HRT)

Primary outcomes:
measure: The relative change in the frequency of hot flushes
timeFrame: At baseline, week 4, 8, 12
Secondary outcomes:
measure: The change in intensity of hot flushes
timeFrame: At baseline, week 4, 8, 12
measure: The relative change in frequency of hot flushes
timeFrame: At baseline, week 4, 8
measure: The change in intensity of hot flushes
timeFrame: At baseline, week 4, 8
measure: The proportions of subjects with urogenital symptoms
timeFrame: At baseline, week 4, 8, 12
measure: Bleeding pattern
timeFrame: At baseline, week 4, 8, 12
measure: Adverse events collection
timeFrame: Collection of AE throughout the study period
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04340128: Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)
Official title: Evaluation of Efficacy of Intra-lesional Injections of Glucantime Once Weekly in Comparison With Twice Weekly in the Treatment of Acute Anthroponotic Cutaneous Leishmaniasis (ACL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cutaneous Leishmaniasis
Keywords: Anthroponotic Cutaneous Leishmaniasis
L. tropica
Meglumine antimoniate (Glucantime)
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Mashad University of Medical Sciences
name: Kerman University of Medical Sciences
First posted: 2020-04-09
Sex: ALL
Minimum age (years): 9
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anthroponotic Cutaneous Leishmaniasis (ACL) is a parasitic disease caused by Leishmania tropica, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a standard treatment for leishmaniasis for last 80 years. Systemic antimonial injection is painful, toxic, not affordable and moreover is not always effective. Many different modalities are used to treat the disease with a limited success. Intra-lesional injections of antimonials are used for the treatment of patients with a few lesions but no data is available on the rate of efficacy. In this study the efficacy of intra-lesional injections of Glucantime weekly is compared with intra-lesional injections of Glucantime twice weekly.


Eligibility criteria: Inclusion Criteria:

* Parasitologically proven cases of CL based on positive smear and/or culture
* Otherwise healthy subjects on the basis of medical history.
* Age 9-70 years
* Willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years).

Exclusion Criteria:

* Pregnant or lactating women
* Duration of lesion more than 6 months
* Number of lesions more than 4
* History of allergy to Glucantime
* Serious systemic illnesses (as judged by the physician)
* Participation in any drug trials in the last 60 days
* No indication for systemic treatment

Primary outcomes:
measure: Complete healing of the lesion(s)
timeFrame: 5 months
Secondary outcomes:
measure: Partiall cure
timeFrame: 5 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: CRTSDL
Study officials:
affiliation: Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences
name: Alireza Khatami, MD MSPH
role: STUDY_DIRECTOR
affiliation: Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences
name: Ali Khamesipour, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kerman University of Medical Sciences
name: Mahdieh Bahrami, MD
role: STUDY_CHAIR
affiliation: Mashhad University of Medical Sciences
name: Mohammad Hossein Ghoorchi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00171028: A Study Of Valsartan Used To Treat Hypertension For Up To 56 Weeks In Children Ages 1 - 5 Years Who Have Hypertension
Official title: A Double-Blind, Randomized, Multi-Center Study Followed By 12 Months Open-Label Treatment To Evaluate The Dose Response And Safety Of Valsartan In Pediatric Hypertension Patients 1 - 5 Years Of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: PEDIATRIC HYPERTENSION
PEDIATRIC
VALSARTAN
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Drugs used to treat hypertension in adults should also be effective in treating high blood pressure in infants and children. This study will test the safety and efficacy of valsartan in lowering blood pressure in children 1 - 5 years old whose parents grant permission to participate.


Eligibility criteria: Inclusion Criteria:

* CHILDREN HAVE BLOOD PRESSURE LEVEL =\>95TH PERCENTILE FOR AGE,GENDER \& HEIGHT
* PARENTAL CONSENT MUST BE GRANTED

Exclusion Criteria:

* BLOOD PESSURE IS =\>25% HIGHER THAN 95TH PERCENTILE FOR AGE, GENDER \& HEIGHT
* SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON EXAMINATION AND LABORATORY OR OTHER ASSESSMENTS

Other protocol-defined exclusion criteria will apply.

Primary outcomes:
measure: Change from baseline systolic blood pressure after 2 and 4 weeks
Secondary outcomes:
measure: Change from baseline systolic blood pressure after 4 weeks
measure: Change from baseline diastolic blood pressure after 2 weeks
measure: Change in 2 week diastolic blood pressure after 2 more weeks
measure: Change in baseline diastolic blood pressure after 4 weeks
measure: Adverse events, serious adverse events, and laboratory values during 4 weeks
Other outcomes:
Locations:
city: E. Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Flynn JT, Meyers KE, Neto JP, de Paula Meneses R, Zurowska A, Bagga A, Mattheyse L, Shi V, Gupte J, Solar-Yohay S, Han G; Pediatric Valsartan Study Group. Efficacy and safety of the Angiotensin receptor blocker valsartan in children with hypertension aged 1 to 5 years. Hypertension. 2008 Aug;52(2):222-8. doi: 10.1161/HYPERTENSIONAHA.108.111054. Epub 2008 Jun 30.
Clinical trial NCT05585528: Informing the Patient on the Type of Management, Surgical or Functional, After Rupture of the Anterior Cruciate Ligament
Official title: Effect of Informing the Patient on the Type of Management, Surgical or Functional, After Rupture of the Anterior Cruciate Ligament : INFO-LCA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ligament Rupture
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2022-10-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, longitudinal, open, non-comparative (single arm), monocentric study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate the proportion of patients after rupture of the anterior cruciate ligament (ACL) of the knee, who will have functional or surgical management (PEC) in 1st intention, after having received appropriate information.

Detailed description: As part of this study, patients will be followed for 1 year with regular functional and quality of life assessments (45 days after inclusion, 3, 6, 9 and 12 months after the start of surgical or non-surgical management). Patients who, during follow-up, will have been redirected towards surgery by the doctor (in the event of functional instability) or who will have chosen to finally move towards surgical PEC, will also be followed.

Eligibility criteria: Inclusion Criteria:

* Rupture, partial or complete, of the anterior cruciate ligament less than 3 months old (confirmed by magnetic resonance imaging);
* Patient with no contraindication to surgery or functional management, according to the medical team;
* Patient able to understand the information related to the study, to read the information leaflet and having consented to participate in the study
* Patient benefiting from a social security scheme;

Exclusion Criteria:

* Grade 3 associated ligament injury on the fibular collateral ligament and/or the tibial collateral ligament;
* Symptomatic meniscal lesion;
* Practice of sport in national or international competition ;
* Recurrence of rupture of the same anterior cruciate ligament;
* Patient with a neurological (motor and/or sensory), vestibular or rheumatic pathology;
* Pregnant woman ;
* Protected adult patient (under guardianship, or under a regime of deprivation of liberty).

Primary outcomes:
measure: Proportion of patients operated at 45 days
timeFrame: 45 days
Secondary outcomes:
measure: Proportion of patients who persist in the choice of non-surgical
timeFrame: 12 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
Study officials:
References:
Clinical trial NCT00415428: A Quality Ensuring Project With Focus On Patients With Cardiovascular Diseases As Well As Type 2 Diabetes.
Official title: Patient And Physician Alliance -Guideline Education Treatment Optimization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Diabetes Mellitus, Type 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-22
Enrollment: 2776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic patients

Brief summary: The overall objective is to increase the adherence to national guidelines for patients with established CVD and/or Type 2 diabetes by means of repeated post-graduate educational meetings and regular evaluation of the optimisation initiatives, demonstrated by improvement of goal attainment in general practice.


Eligibility criteria: Inclusion Criteria:

* Subjects had to meet all of the inclusion criteria to be eligible for enrollment into the study. The following subjects qualify for inclusion in the study:
* Subjects for whom measurement of total cholesterol, low density lipoprotein (LDL) cholesterol, blood pressure (BP) and glycosylated hemoglobin (HbA1c) was planned independently of this observational study and for whom baseline values were or became available.
* Subjects with known CVD diagnosed \> or = 6 months before inclusion
* Previous myocardial infarction
* Ischemic heart disease (stable and unstable angina pectoris)
* Ischemic apoplexy
* Peripheral arterial disease
* And/Or
* Subjects with T2D diagnosed \> or = 6 months before inclusion
* At least 50% of the subjects had to have CVD as the primary diagnosis. It was allowed for a secondary diagnosis to be \<6 months before inclusion.

Exclusion Criteria:

* Subjects presenting with any of the following were not to be included in the study:
* Life expectancy of \< or = 2 years
* Unable/unwilling to understand/follow instructions
* Taking part in a clinical study involving an investigational drug
* Followed by a specialist for their CVD and/or T2D at the time of inclusion in the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02381028: Topical Treatment With Fresh Human Milk Versus Emollient on Atopic Eczema Spots in Young Children
Official title: Topical Treatment With Fresh Human Milk Versus Emollient on Atopic Eczema Spots in Young Children: A Small, Randomized, Split Body, Controlled, Blinded Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Eczema
Keywords: Atopic eczema
Human milk
Topical treatment
Children
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 9
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this small pilot study is to assess the potential effects and risks of applying fresh human milk locally on eczema spots in children with atopic eczema. This is a split body, controlled, randomized and physician blinded pilot study, of children with atopic eczema with two similar contralateral eczema spots having a mother breastfeeding the child or a sibling. Fresh expressed milk and emollient is to be applied on the intervention spot and emollient alone on the control area, three times a day for four weeks. Severity and area of the eczema spots is evaluated weekly, and samples from milk and the spots were analysed weekly with respect to bacterial colonisation.


Eligibility criteria: Inclusion Criteria:

* Children with atopic eczema according to Hanifin and Rajkas criteria with a mother breastfeeding the child or a sibling.
* The eczema spots in the treatment and control areas were to be similar in features and extent as well as being localized on contralateral parts of the body.

Exclusion Criteria:

* Children were excluded if the severity of the eczema spots indicated need for treatment with antibiotics and/or steroids.

Primary outcomes:
measure: Proportional change in area of the eczema spot from baseline
timeFrame: four weeks
Secondary outcomes:
measure: Transmission of bacteria from mother's milk to eczema spots in the child
timeFrame: four weeks
Other outcomes:
Locations:
Study officials:
affiliation: Oslo University Hospital
name: Teresa L Berents, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berents TL, Ronnevig J, Soyland E, Gaustad P, Nylander G, Loland BF. Topical treatment with fresh human milk versus emollient on atopic eczema spots in young children: a small, randomized, split body, controlled, blinded pilot study. BMC Dermatol. 2015 May 4;15:7. doi: 10.1186/s12895-015-0027-9.