louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02823964: EASY: Extended Access to Sollpura Over Years
Official title: An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Exocrine Pancreatic Insufficiency
Cystic Fibrosis
Keywords: exocrine pancreatic insufficiency
cystic fibrosis
pancreatic enzyme replacement therapy
Lead sponsor: Anthera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-07-06
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice.

Detailed description: The purpose of the present study is to evaluate the safety of long-term use of liprotamase in the management of cystic fibrosis-related exocrine pancreatic insufficiency

Eligibility criteria: Inclusion Criteria:

* Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis)

Exclusion Criteria:

* Any medical, psychological, or social condition that may put the subject at increased risk by participating in this study.
* Females who are nursing, pregnant, intending to become pregnant, or intending to nurse during the time of the study.

Primary outcomes:
measure: Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Investigator Site 114
state: Colorado
city: Jackson
country: United States
facility: Investigator Site 134
state: Mississippi
city: Burlington
country: United States
facility: Investigator Site 121
state: Vermont
city: Brno
country: Czechia
facility: Investigator Site 501
city: Debrecen
country: Hungary
facility: Investigator Site 303
state: Hajdu-Bihar
city: Torokbalint
country: Hungary
facility: Investigator Site 302
state: Pest County
city: Mosdos
country: Hungary
facility: Investigator Site 304
state: Somogy County
city: Ajka
country: Hungary
facility: Investigator Site 301
state: Veszprem County
city: Jerusalem
country: Israel
facility: Investigator Site 601
city: Karpacz
country: Poland
facility: Investigator Site 203
city: Lodz
country: Poland
facility: Investigator Site 206
city: Lublin
country: Poland
facility: Investigator Site 205
city: Rabka-Zdroj
country: Poland
facility: Investigator Site 202
city: Rzeszow
country: Poland
facility: Investigator Site 209
city: Madrid
country: Spain
facility: Investigator Site 401
Study officials:
References:
Clinical trial NCT03555864: Intravenous Access Using Infrared Laser
Official title: Peripheral Intravenous Cannulation With Support of Infrared Laser Vein Viewing System in Obese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Obstetric Anesthesia Problems
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that need second intravenous access for surgery or obstetric

Brief summary: Peripheral venous access is a prerequisite for anesthesiological for surgical patients.It is often difficult to establish and potentially painful in obese patients (Body mass Index \> 35). AV300 uses near infrared laser light to improve visibility of peripheral veins and could help cannulating them. The aim of this study was to examine if use of Accuvein(®) AV300 vein viewer could facilitate venous cannulation in obese patients (surgical and obstetric).


Eligibility criteria: Inclusion Criteria

* \> 18 years
* surgery that need double intravenous perfusion

Exclusion Criteria:

* \< 18 years
* body mass index\< 35
* refusal
* minor surgery that need only one intravenous access

Primary outcomes:
measure: success for second intravenous line using infra red
timeFrame: 1 day
Secondary outcomes:
measure: time
timeFrame: 1 day
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: jean-yves Lefrant, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03744364: Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor
Official title: Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor Beyond 41st Week: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Induced Labor
Cervical Ripening
Obstetric Labor
Pregnancy
Keywords: Dinoprostone
Misoprostol
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose:

To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies.

Methods:

The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable.


Eligibility criteria: Inclusion Criteria:

* Singleton uncomplicated pregnancy
* Nulliparity
* Live fetus
* 286 days of gestational age or above
* Abscence of contraindication for vaginal delivery
* Bishop score lower than 6

Exclusion Criteria:

* Multiple pregnancy
* Multiparity
* Stillbirth
* Oligohydramnios
* Suspected fetal distress
* Severe asthma
* Intolerance/allergy to prostaglandins
* Contraindication for vaginal birth

Primary outcomes:
measure: Successful vaginal delivery within 24 hours
timeFrame: 24 hours since induction was started
Secondary outcomes:
measure: Successful cervical ripening within 24 hours
timeFrame: 24 hours since induction was started
measure: Interval time from induction to delivery
timeFrame: Hours passed between induction of labor until delivery within 72 hours
measure: Need for a second induction
timeFrame: Assessed 24 hours since induction of labor was started
measure: Vaginal delivery rate
timeFrame: Since labor induction had started until delivery had ocurred within 72 hours
Other outcomes:
Locations:
Study officials:
References:
citation: De Bonrostro Torralba C, Tejero Cabrejas EL, Envid Lazaro BM, Franco Royo MJ, Roca Arquillue M, Campillos Maza JM. Low-dose vaginal misoprostol vs vaginal dinoprostone insert for induction of labor beyond 41st week: A randomized trial. Acta Obstet Gynecol Scand. 2019 Jul;98(7):913-919. doi: 10.1111/aogs.13556. Epub 2019 Feb 24.
Clinical trial NCT00140764: Intravaginal Treatment of Disturbances of Vaginal Flora Among HIV Infected and Uninfected Women in Malawi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Vaginosis
Trichomonas Vaginitis
Urogenital Diseases
Keywords: Genitourinary symptoms
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2005-09-01
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this intervention is to find out whether intravaginal treatment with a gel containing an antibiotic (metronidazole), compared to a similar placebo gel (without antibiotic), can reduce the frequency of bacterial vaginosis, a common vaginal infection among African women who are HIV uninfected or HIV infected. The study will also determine the effect of these vaginal gels on genitourinary symptoms.

Detailed description: This is a phase 3, randomized, double masked, two arms study conducted in Malawi, Southeast Africa. The study is conducted among nonpregnant HIV infected or uninfected women of reproductive age. Intermittent mass treatment approaches are followed where women are randomized to antibiotic intravaginal treatment or placebo at enrollment. Women receive assigned product every three months for one year.

Eligibility criteria: Inclusion Criteria:

Nonpregnant HIV-Uninfected HIV-Infected

Exclusion Criteria:

Pregnant

Primary outcomes:
measure: Prevalence of bacterial vaginosis
measure: Reported genitourinary symptoms
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Taha E Taha, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aizire J, Dadabhai S, Taulo F, Makanani B, Gadama L, Sun J, Tsui A, Taha TE. Use of effective family planning methods and frequency of sex among HIV-infected and HIV-uninfected African women. Contracept Reprod Med. 2018 Jul 9;3:10. doi: 10.1186/s40834-018-0063-z. eCollection 2018.
Clinical trial NCT05888064: Multi-parametric Imaging in Personalized Radiotherapy
Official title: A Technical Framework for Combining Multi-parametric Imaging With Advanced Modelling in Personalized Radiotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skull Base Chordoma
Lead sponsor: CNAO National Center of Oncological Hadrontherapy
Sponsor class: OTHER
Collaborators: name: Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy
First posted: 2023-06-05
Enrollment: 35
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: skull-based chordoma patients treated with particle therapy at the National Center for Oncological Hadrontherapy (CNAO, Pavia, Italy).

Brief summary: The study consists in the retrospective and prospective collection of imaging data (along with clinical information related to treatment) of skull-base chordoma patients treated with particle therapy, to derive imaging biomarkers which, integrated with advanced mathematical models, will allow predicting treatment outcome on a multi-scale basis.

Detailed description: The study design consists of the retrospective collection of routinely-acquired data (CT, MRI and dose maps, along with relevant clinical information) and the prospective acquisition of optimized non-invasive MR imaging data, of skull-based chordoma patients treated with particle therapy (PT) at the National Center for Oncological Hadrontherapy (CNAO, Pavia, Italy).

This data will be stored in a proper repository under CNAO's control, shared with Politecnico di Milano through encrypted channels, and it will be used to implement mathematical models able to predict treatment outcome at different scales (macroscopic, microscopic and radiobiological).

Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed diagnosis of chordoma of the skull base
* Particle therapy with curative intent
* Karnofsky Performance status greater than or equal to 60
* Patients with macroscopic disease detectable at pre-radiotherapy imaging
* Patients undergoing PT with standardized treatment procedures
* Patients who have signed the written informed consent for research

Exclusion Criteria:

* Metastatic disease
* Palliative treatment
* Other malignancies with disease-free interval \< 5 years (excepting pre- cancerous lesions)
* Pregnancy
* Simultaneous CHT or Immunotherapy
* Extensive metal instrumentation/implants
* Patients with autoimmune diseases (ADs) -including collagen-vascular (CVD) and inflammatory bowel (IBD)

Primary outcomes:
measure: collect data from MRI acquisition
timeFrame: 1 year from the treatment provided in routine clinical setting
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: CNAO
state: Pv
Study officials:
affiliation: CNAO National Center of Oncological Hadrontherapy
name: Alberto Iannalfi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03333564: Effect of Vitamin D3 and Omega-3FA on Estradiol
Official title: Effect of Vitamin D3 and Omega-3FA on Estradiol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D3
Vitamin D deficiency
estradiol
omega-3 fatty acids
menopausal
Lead sponsor: Applied Science Private University
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 116
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The effect of vitamin D3 and omega-3 Fatty acids on estradiol levels.

Detailed description: The data about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum levels of estradiol (E2) are scarce and conflicting and nothing is published in the literature about the effect of the combination of VD3 and omega-3FA on the E2 levels.

This study was conducted to investigate effect of VD3 and omega-3FA alone and with each other on serum E2 levels in premenopausal females with vitamin D deficiency (VDD).

This randomized, placebo-controlled clinical trial was designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks, separately and with each other, on the mid-follicular serum levels of E2 and 25-hydroxy vitamin D (25OHD). This study was conducted during winter in 86 healthy premenopausal Jordanian females with VDD with a mean age of (32.8 ± 8.9) years. Fasting serum levels for 25OHD, E2, PTH (parathyroid hormon), calcium, phosphate, ALT (alanine aminotransferase), and urea were assessed at baseline and the end of the trial.

Eligibility criteria: Inclusion Criteria:

* Premenopausal females
* Medical diagnosis of vitamin D deficiency (VD \< 30 ng / ml)

Exclusion Criteria:

* Women previously diagnosed with any chronic disease such as kidney diseases were excluded from the study due to the effect of prolonged administration of VD3 on kidney stones formation. Women who are pregnant, breastfeeding or using hormonal contraceptives were also excluded.

Primary outcomes:
measure: Plasma concentrations of 25-hydroxyvitamin D, estradiol
timeFrame: 8 weeks
Secondary outcomes:
measure: Plasma concentrations of PTH, Ca
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Applied Science Private University
name: Mahmoud S Abu-Samak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.
citation: Al-Shaer AH, Abu-Samak MS, Hasoun LZ, Mohammad BA, Basheti IA. Assessing the effect of omega-3 fatty acid combined with vitamin D3 versus vitamin D3 alone on estradiol levels: a randomized, placebo-controlled trial in females with vitamin D deficiency. Clin Pharmacol. 2019 Feb 4;11:25-37. doi: 10.2147/CPAA.S182927. eCollection 2019.
Clinical trial NCT06596564: Using Nudge Strategies to Promote Healthier Beverage Intake Among College Students
Official title: A Study on Nudge Interventions to Promote Changes in Sugar-Sweetened Beverage Consumption Behaviors Among College Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Food Selection
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to investigate whether three nudging interventions would affect the beverage selection and consumption behaviors of Chinese university students. These interventions encompass providing information on the sugar content of sugar-sweetened beverages (SSBs), disseminating harmful information about SSBs, and showcasing the social norm that the majority of students opt for mineral water. Through a single-factor between-subjects experiment, we aim to examine the impact of these nudge interventions on the proportion of students choosing sugary drinks versus mineral water, thereby assessing their effectiveness in guiding healthier beverage choices.

Detailed description: As the prevalence of overweight, obesity, and chronic diseases continues to escalate, excessive consumption of sugar-sweetened beverages (SSBs) has emerged as a growing public health concern globally. One approach to reducing beverage intake while conserving resources is the utilization of nudge strategies. Nudge strategies, characterized by their low cost and ease of implementation, facilitate individuals in making more accurate and beneficial choices in a predictable manner, through subtle interventions that do not prohibit any options or significantly alter incentives. This nudge experiment will be conducted in a classroom setting, where participants will be randomly assigned to four groups for beverage selection: No Nudge Intervention Group, Sugar Content Information Nudge Group, Sugar Harmful information Nudge Group and Social Norm Nudge Group. Participants will access the nudge content specific to their respective groups via the professional survey platform of Questionnaire Star and make a choice between cola and mineral water.

Eligibility criteria: Inclusion Criteria:

* college students
* 18 years or above of age
* willing to participate

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of students who chose cola
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00985764: Venous Air Embolism in Cesarean Delivery, Especially Placental Previa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Delivery With Placental Previa
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-09-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cesarean delivery with placental previa

Brief summary: Effects of placenta previa on incidence and severity of venous air embolism in patients during cesarean delivery


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteer with cesarean delivery

Exclusion Criteria:

* the one who rejects to participate

Primary outcomes:
measure: read sonography records during the surgery
timeFrame: After 1 or 2 weeks of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT00701064: Bright Light: An Adjunct Treatment for Combat Posttraumatic Stress Disorder (PTSD)
Official title: Bright Light: An Adjunct Treatment for Combat PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: posttraumatic stress disorder
phototherapy
anxiety
depression
sleep
negative ion generator
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Arizona State University
First posted: 2008-06-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are testing novel treatments for combat PTSD: bright light exposure and negation ion exposure.

Detailed description: Seventy Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with posttraumatic stress disorders (PTSD) will be randomly assigned to one of two 4-week treatments (45 min/day): (1) bright light exposure or (2) a negative ion generator. Clinical assessments ,as well as self-reported measures of PTSD, anxiety, depression, and sleep will be assessed

Eligibility criteria: Inclusion Criteria:

* Veteran of Operation Iraqi Freedom or Operation Enduring Freedom with Posttraumatic Stress Disorder
* receiving other treatment or stopped other treatment prior to study

Exclusion Criteria:

* bipolar disorder
* psychosis
* alcohol/drug abuse

Primary outcomes:
measure: Clinical Assessed PTSD Scale (CAPS-2)
timeFrame: Mean change from baseline to post-treatment (5-6 weeks later)
measure: Clinical Global Impressions Scale (CGI)
timeFrame: Baseline severity to post-treatment (4 weeks later) Change
Secondary outcomes:
measure: Posttraumatic Stress Disorder Checklist (PCL-M)
timeFrame: Baseline to following 4-week treatment
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
state: Arizona
Study officials:
affiliation: Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
name: Shawn D. Youngstedt, PhD
role: PRINCIPAL_INVESTIGATOR
References: