louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01823094: CTP Imaging of Lung Cancer
Official title: CTP (Computed Tomography Perfusion) Imaging of Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: lung cancer
computed tomography
blood flow
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Radiological Society of North America
First posted: 2013-04-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with non small cell lung cancer who are planned to receive systemic therapy

Brief summary: Investigators hope to learn more about how to use computed tomography (CT) scans to measure blood flow in lung tumors and how it may change in response to treatment. This measurement technique is called computed tomography perfusion (CTP). CT scanners use X-rays to produce 3-dimensional images of the body.

Currently, doctors determine the response to treatment by measuring the size of the tumor. Investigators are trying to find out if measuring the blood flow in the tumor is equal to or better than measuring the size of the tumor.

Detailed description: This is an experimental study of CT perfusion (CTP) imaging in subjects with non-small cell lung cancer. The objectives of this study are to demonstrate the feasibility of CT blood flow measurements in lung cancer, to develop a foundation for the use of CT blood flow measurements in lung cancer to assess the response to treatment, and to develop an optimized CTP imaging protocol for evaluating blood flow in solid body tumors. In this study, tumor blood flow will be evaluated at baseline and follow-up routine CT examinations of patients with non-small cell lung cancer, and the response of tumor blood flow will be recorded as a secondary endpoint. This research study will entail two study visits - one required and one optional - which will coincide with regularly scheduled standard of care CT scans.

Eligibility criteria: Inclusion Criteria:

adult patients with non small cell lung cancer who receive, or are considered for, systemic therapy

Exclusion Criteria:

renal failure pregnancy known contrast allergy

-

Primary outcomes:
measure: Yield of conducting CTP studies
timeFrame: 2 years
Secondary outcomes:
measure: Variability of CTP measurements
timeFrame: 2 years
measure: Magnitude of treatment induced changes in tumor blood flow
timeFrame: 2 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: Univeristy of California, Davis
name: Friedrich Knollmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06850194: Vertical Ramus Osteotomy With Iliac Graft Versus Sagittal Split Osteotomy
Official title: Evaluating the Efficacy of Vertical Ramus Osteotomy With Iliac Graft Versus Bilateral Sagittal Split Osteotomy for the Correction of Mandibular Deficiency in Skeletal Class II Cases Management. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mandibular Deficiency
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 20
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: * Patients will be collected from faculty of dentistry
* bilateral vertical ramus osteotomy (VRO )with iliac graft group (group I):- 10 patients will be treated via VRO and iliac crest or
* bilateral sagital spilt osteotomy (BSSO) group (group II):- 10 patients will be treated via BSSO
* All patients will be studied by comprehensive clinical oral and maxillofacial examination and lateral cephalometric radiographic analyses, within 1 week before the surgery (T0), immediately after the surgery (T1), and 6 months after surgery (T2).
* All lateral cephalometric radiographs and clinical photographs must be standardized for all cases.
* After pre-surgical orthodontic treatment , a lateral cephalograph Will be obtained for planning the surgical movement of both jaws
* Surgical models and surgical stent will be fabricated.
* All surgical procedures will be performed under nasal intubation and general anesthesia to surgically reposition the maxilla in standard LeFort I setback fosteotomy; the BSSO group will be underwent BSSO, and VRO group will be underwent VRO
* The bony segments will be fixed in the new position with the use of custom made plates (specific for each patient )


Eligibility criteria: Inclusion Criteria:

* patients with age above 18 years old suffered from skeletal class II with severe mandibular deficiency

Exclusion Criteria:

* patients with chin deviation,
* severe temporomandibular joint (TMJ) symptoms.
* Sever periodontal disease
* pregnancy,
* previous mandibular surgery,
* inability to follow-up for the study protocol

Primary outcomes:
measure: skeletal stability
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beni-seuf
country: Egypt
facility: Beni-Suief University
Study officials:
References:
Clinical trial NCT03344094: Mechanism of Action of Ocrelizumab in Multiple Sclerosis
Official title: Mechanism of Action of Ocrelizumab in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Immune System Diseases
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MS and healthy controls from the U of Chicago Neurology Clinic population

Brief summary: Ocrelizumab is FDA approved for therapy of multiple sclerosis (MS). It depletes B cells and stops MS inflammation.

Detailed description: The study will investigate immune cell subsets, and how the cells are modified by this therapy over a 1-year period in 25 subjects. Blood will be drawn at baseline, 2 weeks, 6 mo, and 12 mo.

Immune subsets will be analyzed by flow cytometry. Data are analyzed with ANOVA with repeated measures.

Eligibility criteria: Inclusion Criteria:

* All patients who are eligible for Ocrelizumab therapy based on FDA criteria

Exclusion Criteria:

* All patients who are ineligible for Ocrelizumab therapy based on FDA criteria.
* Prior treatment with Alemtuzumab or stem cell therapy, or immune abnormalities that would interfere with planned tests.
* Hepatitis B and HIV infections.
* Pregnant or lactating women.
* Hypersensitivity to trial medications.

Primary outcomes:
measure: Number of Participants With Complete Depletion of B Cells
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: anthony t reder, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01037894: Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?
Official title: Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: Acupuncture,Intracerebral hemorrhage, Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to establish whether acupuncture in addition to conventional rehabilitation programme can improve the functional outcome and quality of life of surgical patients with haemorrhagic stroke, as compared to conventional rehabilitation programme alone.

Detailed description: The investigators aim to recruit 60 patients over a 30 month period. Each patient will have six week of acupuncture treatment (either early within the first six week, or delayed after the first six week of observation and assessment of primary outcome).

Primary outcome measures:

Clinical outcome at the end of week 6 acupuncture treatment: Glasgow Outcome Score extended.

Secondary outcome measures:

Modified Rankin Score, Functional Independence Measure (FIM) score, Modified Aschoff Score, Neurocognitive State Examination (NCSE) score, Barthel index, Modified Rivermead Mobility Index (MRMI), Modified Functional Ambulation Category (MFAC) and motor scores of upper limb and lower limb with Fugl-Meyer Scale at the end of week six acupuncture treatment.

Eligibility criteria: Patient inclusion Criteria:

1. Patients after acute hemorrhagic stroke;
2. Within the first month after acute presentation;
3. Premorbid mobility level: Independent Indoor or Outdoor Walker;
4. Co-operative and willing to comply with the rehabilitation program;

Patient exclusion Criteria:

1. Cardiac Pacemaker;
2. Patient who is apprehensive to acupuncture;
3. Clotting abnormality;
4. Poor local skin conditions.

Primary outcomes:
measure: Glasgow Outcome Scale Extended
timeFrame: Six week
Secondary outcomes:
measure: Functional Independence Measure (FIM) score
timeFrame: Six week
measure: Modified Aschoff Score
timeFrame: Six week
measure: Neurocognitive State Examination(NCSE)score
timeFrame: Six week
measure: Motor scores of upper limb and lower limb with Fugl-Meyer Scale
timeFrame: six week
measure: Modified Functional Ambulation Category (MFAC)
timeFrame: Six week
measure: Modified Rivermead Mobility Index (MRMI)
timeFrame: Six week
measure: Barthel Index
timeFrame: Six week
measure: Modified Rankin Scale
timeFrame: Six week
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
state: Hong Kong
Study officials:
affiliation: Division of Neurosurgery, CUHK
name: George KC Wong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02050594: Ipilimumab 12-month Intensive Pharmacovigilance Protocol
Official title: Ipilimumab 12-month Intensive Pharmacovigilance Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: JSS Medical Research Inc.
First posted: 2014-01-31
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bristol Myers de Venezuela S.A.C. has in place a Customer Model registry, which tracks every Ipilimumab prescription in Venezuela. Therefore, any oncologist who treats a patient with Ipilimumab will be identified by BMS. Use of this registry will ensure all patients who are infused with Ipilimumab are included in this study

Brief summary: The primary objective of the protocol is to identify and describe observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study period


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Age of 18 years or older on date of first dose of Ipilimumab
* Subjects who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or metastatic melanoma in Venezuela

Exclusion Criteria:

* Subjects who received Ipilimumab as part of a clinical trial
* Subjects who received Ipilimumab for any indication other than local approval (ie, unresectable or metastatic melanoma)

Primary outcomes:
measure: Descriptive statistics of observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela
timeFrame: Up to 12 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06560294: Glue Embolization vs Conservative Treatment for Pelvic Congestion Syndrome
Official title: Glue Embolization Versus Conservative Treatment for Pelvic Congestion Syndrome: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glue Embolization
Pelvic Congestion Syndrome
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare glue embolization and conservative treatment for pelvic congestion syndrome regarding safety and efficacy.

Detailed description: Pelvic congestion syndrome (PCS) is a common cause of chronic lower abdominal/pelvic pain, estimated to affect about 40 % of women, predominantly between the ages of 30 and 45.The treatment of PCS depends mainly on the severity of the pain. Non-steroid anti-inflammatory drugs are often used, and contraceptives have a role in cases of pain associated predominantly with menstruation.

Traditionally, conservative approaches, such as pharmacotherapy with venoactive drugs like micronized purified flavonoid fraction (Daflon), have been utilized to address the symptoms of PCS. Daflon has been used to treat venous insufficiency and has demonstrated efficacy in reducing symptoms and improving the quality of life in patients with PCS. Its mechanism of action includes improving venous tone, reducing venous stasis, and exerting anti-inflammatory effects. Endovascular treatment of PCS is challenging and requires occlusion of incompetent pelvic veins.

Eligibility criteria: Inclusion Criteria:

* Women aged from 30 to 50 years.
* Complaining from pelvic congestion syndrome.

Exclusion Criteria:

* Pregnant women at any gestational age, women who gave birth less than 12 months ago, and breastfeeding mothers.
* Patients who are treated with opiates to reduce pelvic pain in the period before the study.
* Patient with history of contrast allergy
* Patient with renal impairment
* Patient has alternative gynecological cause of chronic pelvic pain as pelvic inflammatory disease (PID), endometriosis, fibroid, adenomyosis, ovarian cyst
* Patient underwent any previous intervention for pelvic congestion syndrome as laparoscopy or surgery.

Primary outcomes:
measure: Degree of pain
timeFrame: Post intervention for 3 months
Secondary outcomes:
measure: Incidence of recurrence of pain
timeFrame: Post intervention for 3 months
measure: Pelvic Venous Clinical Severity Score (PVCSS)
timeFrame: Post intervention for 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: ElGharbia
Study officials:
References:
Clinical trial NCT04852094: Family-centered Round in Neonatology
Official title: Family-centered Round in Neonatal Units : Process Development and Implementation Using the Intervention Mapping
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prematurity
Keywords: Newborn
Preterm
medical round
family-centered care
NICU
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents group: age, parity, education and income level Staff group: age, gender, years of experience in the NICU, profession

Brief summary: The family-centered care is based on dignity and respect, information sharing, collaboration and participation in care and decision-making. In a neonatal unit, the medical round by the attending physician is an important moment for shairing information with the medical and nursing staff and for the decision making process. In France, parents are rarely actively involved in the medical round. The aim of this study is to plan the implantation of the Family-centered round in a neonatal department using the 6 steps of the "Intervention mapping": 1/needs assessment; 2/ performance and change objectives; 3/ theory-based framework; Curriculum development; 5- adoption and implementation; 6- evaluation and dissemination


Eligibility criteria: Parents Group:

Inclusion Criteria:

* French speaking
* voluntary to participate
* parents of an hospitalized newborn

Exclusion Criteria:

* not fluent in French speaking
* mental health problems

Professional group:

* any staff member
* voluntary to participate

Primary outcomes:
measure: Experience of participating to a Family-Centered Care (FCR)
timeFrame: 1 day during the last week of their newborn 'hospitalisation
Secondary outcomes:
measure: Experience of staff members in participating to a (FCR)
timeFrame: 1 day after 3 months of FCR experience
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: University Hospital, Brest
name: Jacques Sizun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00931294: Saliva Testosterone Increases in Irritable Bowel Syndrome (IBS) Patients Beginning Choir Singing
Official title: Saliva Testosterone Increases in Choir Singer Beginners: a Randomised Controlled Trial to Test the Efficacy of Choir Singing in Irritable Bowel Syndrome (IBS) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Stockholm University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Region Stockholm
First posted: 2009-07-02
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis was that a one-year experience of choir singing once a week is more beneficial than group discussions to saliva concentration of testosterone.

Detailed description: The project aimed to study the health effects of regular choir singing for persons who are in a psychosomatic condition (Irritable Bowel syndrome - IBS). A group of IBS patients were randomized to choir singing or an information group were followed during one year with biological and psychosocial assessments. The choir group participated in various relaxation, breathing and vocal exercises with the choir leader, and received the material "To live with IBS" for home studies. At the same time a comparison group with IBS patients meet in groups, studying and discussing on the same materials under the direction of a group leader. Both groups meet once per week.

Eligibility criteria: Inclusion Criteria:

* IBS according to physician certificates.
* Wish to start choir singing but no such experience during past ten years.
* Acceptance of randomisation condition.

Exclusion Criteria:

* No serious somatic diseases.
* No abuse of alcohol or drugs.
* No ongoing acute psychiatric condition.

Primary outcomes:
measure: More reduction in bowel pain according to standardised international IBS questionnaire in choir group than in study group after one year.
timeFrame: 1 year
Secondary outcomes:
measure: Significant increase in saliva testosterone concentration during study period in choir group.
timeFrame: 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
Study officials:
affiliation: Stress Research Institute at Stockholm University
name: Töres Theorell, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christina Grape RN, Theorell T, Wikstrom BM, Ekman R. Choir singing and fibrinogen. VEGF, cholecystokinin and motilin in IBS patients. Med Hypotheses. 2009 Feb;72(2):223-5. doi: 10.1016/j.mehy.2008.09.019. Epub 2008 Oct 31. No abstract available.
Clinical trial NCT02968394: Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions
Official title: Influence of Omalizumab Co-treatment on Honey-bee Venom Immunotherapy Failure Due to Systemic Reactions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergy
Bee Venom
Immunotherapy
Omalizumab
Lead sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 11
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: The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to systemic reactions.

Detailed description: Some honey bee venom allergic patients cannot be treated with venom immunotherapy due to systemic reactions during immunotherapy - immunotherapy failure due to systemic reactions. High basophil allergen sensitivity is a risk factor for venom immunotherapy failure due to systemic reactions. Omalizumab decreases basophil sensitivity. Venom immunotherapy failure patients will be co-treated with omalizumab during another attempt of immunotherapy introduction. Patients will be clinically and immunologically followed up after the introduction.

Eligibility criteria: Inclusion Criteria:

* severe anaphylactic reaction after honey-bee sting (Mueller grade III or IV) confirmed sensitization to honey-bee venom,
* honey-bee venom immunotherapy treatment failure due to systemic reactions.

Exclusion Criteria:

* systemic mastocytosis,
* pregnancy,
* use of beta-adrenergic blocking agents.

Primary outcomes:
measure: Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment.
timeFrame: 2 months
Secondary outcomes:
measure: Changes in basophil sensitivity during omalizumab co-treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: Golnik
country: Slovenia
facility: University Clinic of Pulmonary and Allergic Diseases Golnik
Study officials:
affiliation: University Clinic of Pulmonary and Allergic Diseases Golnik
name: Mitja Košnik, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04321694: Expanded Access for KHK2455
Official title: Expanded Access for KHK2455
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Glioblastoma Multiforme
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of New Mexico Cancer Center
First posted: 2020-03-25
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access program for eligible participants. This program is designed to provide access to KHK2455 in combination with Mogamulizumab prior to the approval by the local regulatory agency. A medical doctor must decide whether the potential benefit outweighs the risk of receiving this investigational therapy based on the individual patients medical history and eligibility criteria.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: