louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00552006: Treatment of Formerly Abducted Children (FAC) in Uganda
Official title: A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus an Attention Control Condition (AC) in Reducing Trauma Related Symptoms in Formerly Abducted Children and Former Child Soldiers Suffering From Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: PTSD
Treatment
Randomized Controlled Clinical Trial
Combat
Child Soldiers
Dissemination
Narrative Exposure Therapy
Africa
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2007-11-01
Enrollment: 85
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the aftermath of traumatic experiences like natural disasters or man-caused traumatic events, such as war experiences, a substantial part of the affected individuals develop a number of psychological symptoms. The characteristic symptom pattern occurring in the aftermath of traumatic events is called posttraumatic stress disorder (PTSD) and includes functional impairment of the affected individuals. The investigators want to test whether Narrative Exposure Therapy (NET) is an effective tool in reducing trauma related symptoms in formerly abducted children and youths and former child soldiers, when applied by lay personnel.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of PTSD (Post-Traumatic Stress Disorder) derived from expert interviews
* member of the group of formerly abducted people or former child soldiers

Exclusion Criteria:

* current substance dependence
* mental retardation
* psychotic disorder

Primary outcomes:
measure: Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale)
timeFrame: 3 months, 6 months and 1 year after completion of treatment
Secondary outcomes:
measure: Load of depressive symptoms measured via the MINI, strength of suicidal ideation measured via the MINI, functionality measured via the CAPS, feelings of guilt measured via the CAPS, stigmatization measured via an adapted version of the PSQ
timeFrame: 3 months, 6 months and 1 year after completion of treatment
Other outcomes:
Locations:
city: Anaka
country: Uganda
facility: Vivo Counselling Centre
state: Amuru
Study officials:
affiliation: Bielefeld University
name: Frank Neuner, Univ.-Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Konstanz
name: Thomas Elbert, Univ.-Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bielefeld University
name: Verena Ertl, Dipl.-Psych. (MSc)
role: STUDY_DIRECTOR
References:
citation: Ertl V, Pfeiffer A, Schauer E, Elbert T, Neuner F. Community-implemented trauma therapy for former child soldiers in Northern Uganda: a randomized controlled trial. JAMA. 2011 Aug 3;306(5):503-12. doi: 10.1001/jama.2011.1060.
Clinical trial NCT03480906: Eyenovia MiDD Usability Study
Official title: An Evaluation of the Usability and Patient Tolerability for Microtherapeutic Dosing of Commercially Available Ocular Medication Via the Eyenovia Microdose Delivery System (MiDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Lead sponsor: Eyenovia Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study is to evaluate the usability and patient tolerability for microtherapeutic dosing of commercially available ocular medication via the Eyenovia microdose delivery system (MiDD)


Eligibility criteria: Inclusion Criteria:

* Healthy patients without significant ocular pathology and mean unmedicated diurnal intraocular pressure (IOP) in the range of of 17-27 mmHg
* Willing to forego use of contact lenses during study period
* Presence of cognition an dexterity necessary to follow MiDD drug administration instructions
* Female subjects must be 1-year postmenopausal, surgically sterilized, or if of childbearing potential, have a negative serum pregnancy test

Exclusion Criteria:

* Prior clinically significant ocular history or abnormal eye exam
* Use of ocular medication within 30 days of screening
* Use of oral steroid within 30 days of screening, or anticipated need for ocular steroid treatment during study period
* History of drug or alcohol abuse within 1 year of screening
* Lid squeezer
* Presence of disabling arthritis or limited motor coordination that would limit self-handling of the MiDD
* Participation in any interventional study of an investigational drug or device within 30 days of screening

Primary outcomes:
measure: Successful microtherapeutic administration to the ocular surface
timeFrame: Treatment Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Panama City
country: Panama
facility: Clinica de Ojos Orillac-Calvo
Study officials:
affiliation: Clinica de Ojos Orillac-Calvo
name: Reuben Orillac, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica de Ojos Orillac-Calvo
name: Ernesto Calvo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06938906: Multimodal Therapy Impact on Pancreatic Cancer Survival
Official title: Survival Outcome Analysis on the Strategy Shift Integrating a Multimodal Therapy of Neoadjuvant Chemotherapy and Extended Pancreatectomy in Pancreatic Cancer: A Clinical Study From a Retrospective Cohort in a Single Institute
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Cancer
Neoadjuvant Chemotherapy
Pancreatectomy
Keywords: pancreatic cancer
neoadjuvant chemotherapy
extended pancreatectomy
multimodal therapy
paradigm shift
survival outcomes
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 405
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 with pancreatic cancer who lived in southern Taiwan.

Brief summary: The goal of this retrospective cohort study is to analyze change of treatment strategies affect the survival outcomes in patients of pancreatic cancer who received curative-intent treatment. The main question it aims to answer is:

Hypothesis: Change of treatment strategies involving increased utility of neoadjuvant chemotherapy and aggressive surgical approaches of extended pancreatectomy improved the overall and progression free survival in the patients with pancreatic cancer.

Participants received curative treatment for pancreatic cancer.

Detailed description: This study is to analyze the change of treatment strategies and shift of the paradigm over time in a single center. Researchers plan to see the impact of the evolvement to the survival outcomes in pancreatic cancer.

Eligibility criteria: Inclusion Criteria:

* Pancreatic adenocarcinoma
* Received curative surgery

Exclusion Criteria:

* Other subtypes of pancreatic cancer including acinar cell carcinoma, mucinous carcinoma, undifferentiated carcinoma and intraductal papillary mucinous neoplasm with associated adenocarcinoma
* Cases with palliative or R2 resection were also excluded from the analysis.

Primary outcomes:
measure: Overall survival and Progression-free survival
timeFrame: From enrollment to two years after the end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: Department of Surgery, National Cheng Kung University Hospital
name: Yan-Shen Shan, MD., PhD.
role: STUDY_CHAIR
affiliation: National Cheng-Kung University Hospital
name: Ting-Kai Liao, MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06776406: Head Stabilization in Whole Brain RT
Official title: Real-Time Head Stabilization of Patients Undergoing Radiation Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-center, single-arm observational study in which the investigators aim to develop an advanced motion control system for head stabilization in patients undergoing whole brain radiation therapy.

Detailed description: Standard of care treatment is to be immobilized with a mask for whole brain radiation therapy. The purpose of this study is to develop a process to track and correct a person's head movements in real time during radiation treatment. To do this, the investigators will use a mask and head holder connected to a robotic support platform which can make small movements of the head holder.

Eligibility criteria: Inclusion Criteria:

* Patients 18 and older undergoing whole brain radiation therapy
* Participants must sign the informed consent form

Exclusion Criteria:

All patients not meeting the above inclusion criteria will not be considered for this study.

Primary outcomes:
measure: Robotic Head Holder Stabilization During Radiation Therapy
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michelle Alonso-Basanta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01675206: Dose Defining Study for the Administration of Vitamin K2 Supplements in Hemodialysis Patients
Official title: Randomized Prospective Open Interventional Multi-centre Study on Finding the Optimal Dose of Vitamin K2 Supplements for Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vascular Calcification
Keywords: Vascular calcification
Hemodialysis
Matrix Gla Protein
Vitamin K2
Lead sponsor: Onze Lieve Vrouw Hospital
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis patients.

Detailed description: During the past few years evidence is emerging for a role of Matrix Gla Protein (MGP) as one of the most powerful inhibitors of vascular calcification (Shurgers LJ et al. Thromb Haemost 2008; 100: 593-603). MGP is a Vitamin K dependent protein. This means that he presence of Vitamin K2 is required to promote the gamma-carboxylation process turning MGP in its carboxylated and active form. Recent data show that dp-uc MGP correlates well with Vitamin K status (Cranenburg CM et al. Thrombosis and Haemostasis 2010; 104/4: 811-822).

It is widely recognized that patients with renal insufficiency treated with hemodialysis are prone to accelerated vascular calcification resulting in excess cardiovascular morbidity and mortality (Goodman WG et al. N Engl J Med 2000; 342: 1478-1483).

Consequently, the administration of Vitamin K2 supplements may protect hemodialysis patients against accelerated vascular calcification by enhancing the gamma-carboxylation process of MGP. However, the optimal dose of Vitamin K2 required to achieve these results remains to be defined

Eligibility criteria: Inclusion Criteria:

* age ≥18 year
* signed informed consent
* end stage renal disease treated with chronic hemodialysis at least three times a week

Exclusion Criteria:

* coumarin treatment
* known intestinal malabsorption
* inability to take oral medication
* medical conditions with a considerable probability for death within 2 months

Primary outcomes:
measure: percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation
timeFrame: 8 weeks
Secondary outcomes:
measure: Assessment of adverse reactions associated with Vitamin K2 intake
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: OLV Hospital Aalst Belgium
name: Rogier Caluwé, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: OLV Hospital Aalst Belgium
name: Bruno Van Vlem, MD, PhD
role: STUDY_CHAIR
affiliation: AZ St.-Jan Brugge Belgium
name: An Devriese, MD, PhD
role: STUDY_CHAIR
affiliation: AZ St.-Jan Brugge Belgium
name: Stefaan Vandecasteele, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05250206: Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes
Official title: Evaluation of Ophthalmic Lenses for Myopia Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Indizen Optical Technologies, S.L.U.
Sponsor class: INDUSTRY
Collaborators: name: Universidad Europea de Madrid
First posted: 2022-02-22
Enrollment: 92
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.

Detailed description: A prospective, double-blind, randomized clinical trial (RCT) to analyze the effect of a new ophthalmic lens prototype on myopia progression. The follow-up period to evaluate the efficacy of the lens will be 3 years including a total of 5 visits.

The sample will consist of a group of 92 myopic children who will be randomly assigned to one of the treatment groups:

* Control group who will receive standard monofocal lenses.
* Treatment group who will wear a prototype lens based on peripheral positive defocus.

Eligibility criteria: Inclusion Criteria:

* Age: 5 to 12 years old
* Myopia (spherical equivalent with cycloplegic) ≤ -0.50D
* Astigmatism \< 1.50D
* Anisometropia \< 1.50D
* Best-corrected visual acuity ≥ 20/20

Exclusion Criteria:

* Patients who have received any previous treatment for myopia control, including the use of RPG contact lenses.
* Participants with ocular pathology such as retinal detachment.
* Participants using drugs that may affect pupillary size and accommodation or that produce effects on the ocular surface.
* Participants with systemic diseases that may affect vision.

Primary outcomes:
measure: Axial Lenght Increase
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Europea of Madrid
Study officials:
References:
citation: Hasebe S, Jun J, Varnas SR. Myopia control with positively aspherized progressive addition lenses: a 2-year, multicenter, randomized, controlled trial. Invest Ophthalmol Vis Sci. 2014 Sep 30;55(11):7177-88. doi: 10.1167/iovs.12-11462.
citation: Kanda H, Oshika T, Hiraoka T, Hasebe S, Ohno-Matsui K, Ishiko S, Hieda O, Torii H, Varnas SR, Fujikado T. Effect of spectacle lenses designed to reduce relative peripheral hyperopia on myopia progression in Japanese children: a 2-year multicenter randomized controlled trial. Jpn J Ophthalmol. 2018 Sep;62(5):537-543. doi: 10.1007/s10384-018-0616-3. Epub 2018 Aug 6.
citation: Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet. 2012 May 5;379(9827):1739-48. doi: 10.1016/S0140-6736(12)60272-4.
Clinical trial NCT03939806: Effects of Oxytocin and Carbetocin on Renal System in Cesarean Sections
Official title: Renal Effects of Carbetocin and Oxytocin in Cesarean Section for Preventing Post-partum Haemorrhage: a Prospective Randomized Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postpartum Hemorrhage
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of term (gestational age greater than 37 weeks) pregnant women scheduled to undergo elective cesarean section.

Brief summary: The aim of this study is to evaluate the renal outcome of patients undergoing elective C/S where oxytocin or carbetocin is used for postpartum hemorrhage prophylaxis.


Eligibility criteria: Inclusion Criteria:

* Term (\>37 weeks of gestation) uncomplicated pregnant women undergoing elective cesarean section

Exclusion Criteria:

* Patients refusing to participate in the study
* Complicated pregnancies
* Patients with risk factors for postpartum hemorrhage
* Contraindications for oxytocin or carbetocin usage
* Patients with known renal diseases
* Preterm births (\<37 weeks of gestation)

Primary outcomes:
measure: Urine volume
timeFrame: Intraoperative period
measure: Urinary sodium
timeFrame: Preoperative, Postoperative 2nd, 4th, 24th hours
measure: Blood sodium
timeFrame: Preoperative, Postoperative 2nd, 4th, 24th hours
Secondary outcomes:
measure: Blood osmolality
timeFrame: Preoperative, Postoperative 2nd, 4th, 24th hours
measure: Blood loss
timeFrame: Intraoperative period
measure: Need for additional uterotonics
timeFrame: Starting from the preoperative period, ending at the 24th postoperative hour
measure: Blood transfusion
timeFrame: Starting from the clamping of the umbilical cord, ending at the 24th postoperative hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University Faculty of Medicine Hospital
state: Balgat
Study officials:
References:
citation: Larciprete G, Montagnoli C, Frigo M, Panetta V, Todde C, Zuppani B, Centonze C, Bompiani A, Malandrenis I, Cirese A, Valensise H. Carbetocin versus oxytocin in caesarean section with high risk of post-partum haemorrhage. J Prenat Med. 2013 Jan;7(1):12-8.
citation: Engstrom T, Barth T, Melin P, Vilhardt H. Oxytocin receptor binding and uterotonic activity of carbetocin and its metabolites following enzymatic degradation. Eur J Pharmacol. 1998 Aug 21;355(2-3):203-10. doi: 10.1016/s0014-2999(98)00513-5.
Clinical trial NCT02327806: The Effect of Pullsed Magnetic Field Induction on Improving the Forearm Tissue Muscle Performance
Official title: The Effect of Pullsed Magnetic Field Induction on Improving the Forearm Tissue Muscle Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medical Oncology
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pulsed electromagnetic field therapy (PEMFT) is a reparative technique most commonly used in the field of orthopedics for the treatment of non-union fractures. The aim is to test the effect of the magnetic induction on brute force of treated muscle in oncological patients. Oncology patients were chosen as we assume that the ipmrovement will be more noticable in oncology patients than in a non-oncology, healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Patiant from the oncology clinic

Exclusion Criteria:

* Known bone disease
* Pregnancy
* Birth defects or acquired uper extremity
* Neurology disease
* Medical history in the forehand
* Pacemaker neural modulation pacer.

Primary outcomes:
measure: Brute force
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Clinical Nutrition Unit, Sourasky Medical Center
Study officials:
References:
Clinical trial NCT03716713: CeraShield™ Endotracheal Tube Feasibility Study
Official title: CeraShield™ Endotracheal Tube Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation, Intratracheal
Lead sponsor: N8 Medical, LLC
Sponsor class: INDUSTRY
First posted: 2018-10-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Single-arm, feasibility study to evaluate the Ceragenin Coated Endotracheal Tube (the CeraShield ETT) in adults who require intubation and are expected to be mechanically ventilated for ≥ 24 hours.


Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older;
* Patients requiring a 7.0mm, 7.5mm, 8.0mm or 8.5mm endotracheal tube;
* Expected to be mechanically ventilated for ≥24 hours.

Exclusion Criteria:

* Currently participating in another clinical trial which conflicts with this trial's design.
* Patients with a pre-existing respiratory infection, i.e., pneumonia.
* Patients with pulmonary contusions.
* Patients with cystic fibrosis.
* Patients demonstrating symptoms of bronchiectasis.
* Patients demonstrating symptoms of severe or massive hemoptysis. Severe or massive hemoptysis defined as greater than 500 ml of blood per day, or greater than 200 ml in six hours.
* Patients who have been intubated within the last 30 days requiring reintubation.
* Women of child-bearing potential who have not undergone a pregnancy test will be excluded from the study.
* Patient is pregnant.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: Up to 30 days post enrollment or hospital discharge, whichever comes first
Secondary outcomes:
measure: Positive QEA
timeFrame: 10 days post intubation
measure: Positive ETT colonization
timeFrame: 10 days post intubation
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
References: