louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01262144: SUV Max as Predictor of Outcome in Cervical Cancer
Official title: A Study to Evaluate the Value of SUV-Max in PET-FDG in Predicting Outcome of Surgery Vis a Vis Need for Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Cervical Cancer
PET CT
SUV Max
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-12-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females age 18-80, diagnosed with cervical cancer

Brief summary: Cervical Cancer is staged clinically, not surgically. Patients in whom an extensive disease is identified are not usually eligible for surgery. PET-CT is used to support staging. However, some patients received surgery after staging and subsequently require radio/chemotherapy due to findings on operation.

This study will attempt to find a correlation between SUV-Max on PET-CT and subsequent outcomes i.e. need for adjuvant therapy.


Eligibility criteria: Inclusion Criteria:

* having stating PET-CT stored on site
* treated with surgery

Exclusion Criteria:

* not eligible for surgery based on PET-CT, clinical stage

Primary outcomes:
measure: Administration of adjuvant therapy
timeFrame: immediately following surgery
Secondary outcomes:
measure: Overall survival
timeFrame: surgery - present day
Other outcomes:
Locations:
city: City
country: Israel
facility: Rambam Medical Center
state: Haifa
Study officials:
affiliation: Rambam Health Care Campus
name: Amnon Amit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01630044: Neurostimulation Device for Treatment of Migraine Headache
Official title: Clinical Pilot Study to Evaluate a Non-Invasive, Neurostimulation Device for Treatment of Migraine Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Headache
Keywords: caloric vestibular stimulation
Lead sponsor: Scion NeuroStim
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 3
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: This is a single-site, prospective, non-randomized and open label study to investigate the feasibility of home-use CVS for the prevention of episodic migraine headache and specifically to better understand what type of waveform to apply.


Eligibility criteria: Inclusion Criteria:

* A history of at least four, and not more than fourteen total monthly headache days of which between four and nine were migraine headache days. (Note: Patients were permitted continued access to migraine abortive medications and were being treated at the Duke University headache clinic.)
* A history of some responsiveness (incomplete) to at least one and a maximum of two prophylactic pharmaceutical therapies (utilized concurrently);
* The investigator must have confidence in the patient's ability to reliably complete and return the Daily Headache Diary.
* Subject must be at least 18 years of age.

Exclusion Criteria:

* Individuals who were pregnant, who had a history of cardiovascular disease, who worked night shifts or who had vestibular migraine, menstrual migraine, post-traumatic migraine, a history of unstable mood disorder or unstable anxiety, moderate or greater hearing loss or a history of traumatic brain injury.
* A history within the last six months of tobacco use, narcotic or barbiturates use or experiencing one or more analgesic rebound headaches.

Primary outcomes:
measure: Number of migraine headache days
timeFrame: Length of the study, about 71 days
measure: Severity of each and of all headaches
timeFrame: Length of study, 71 days
Secondary outcomes:
measure: Total Monthly Headache Pain Score
timeFrame: Length of study, about 71 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Medicine / Neurology
state: North Carolina
Study officials:
affiliation: Duke University
name: Daniel Laskowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Black RD, Rogers LL, Ade KK, Nicoletto HA, Adkins HD, Laskowitz DT. Non-Invasive Neuromodulation Using Time-Varying Caloric Vestibular Stimulation. IEEE J Transl Eng Health Med. 2016 Oct 7;4:2000310. doi: 10.1109/JTEHM.2016.2615899. eCollection 2016.
Clinical trial NCT00287144: Post Partum Thyroiditis 2: Long Term Observations
Official title: Observations of Leng Term Effects From Post Partum Thyroiditis.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypothyroidism
Keywords: Hypothyroidism
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
First posted: 2006-02-06
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long-term follow-up of women who developed post-partum thyroiditis within 6 weeks after birth in 1985

Brief summary: The study tries to determine if post partum thyroiditis has marked long term (20 years after partum) risk for developing hypothyroidism.

Detailed description: This is study where we follow up women who in 1985 were checked for the occurrence of post partum thyroiditis 6 week after labour. The former patients have been invited to participate by answering a questionnaire and by providing results from blood tests.

Eligibility criteria: Inclusion Criteria:

* Defined group of women who tested positive for post partum thyroiditis in 1985.
* Control group randomly picked from those who tested negative.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Skien
country: Norway
facility: Sykehuset Telemark HF
Study officials:
affiliation: Sykehuset Telemark HF, Skien, Norway
name: Janna Berg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06570044: Evaluation of PerioMonitor for Detection of Oral Inflammatory (OI) in Human Subjects in Medical Practice
Official title: Evaluation of PerioMonitor for Detection of Oral Inflammatory (OI) in Human Subjects in Medical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Inflammation
Lead sponsor: Oral Science International Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to evaluate the usability of PerioMonitor™ in a medical clinic environment and to evaluate the effectiveness of a referral system from physicians to dentists for patients identified with high oral inflammation.

PerioMonitor™ is an In Vitro Diagnostic (IVD) device intended as an aid in the detection of oral inflammation in individuals of 18 years and older. This test is intended for use at point-of-care (POC) sites by health care professionals (e.g., physicians, nurses, medical assistants, dentists, dental hygienists, and dental assistants).


Eligibility criteria: Inclusion Criteria:

* subject fluent in English
* subject has signed the ICF

Exclusion Criteria:

* subject with altered mental status/inability to provide informed consent or follow the procedure of the Study
* Previous enrolment into the current Study
* Patients with known severe oral diseases such as oral cancer

Primary outcomes:
measure: Ratio (%) of valid tests/performed tests
timeFrame: Day 0
measure: Ease of Test Performance
timeFrame: Day 0
measure: Use error
timeFrame: Day 0
measure: Comfort to participants
timeFrame: Day 0
Secondary outcomes:
measure: Proportion (%) of participants referred to a Dental Specialist
timeFrame: 6-Month
measure: Proportion (%) participants referred to a Dental Specialist
timeFrame: 12-Month
measure: Proportion (%) of compliant participants with the recommended visit to a Dental Specialist
timeFrame: 6-Month
measure: Proportion (%) of compliant participants with the recommended visit to a Dental Specialist
timeFrame: 12-Month
Other outcomes:
Locations:
city: Buckeye
country: United States
facility: 1st Family Medicine
state: Arizona
Study officials:
affiliation: University of Florida
name: Samuel B Low
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06841744: Effects of Diaphragmatic Breathing on Pain, Function, Balance and Quality of Life in Pregnant Women With Low Back Pain
Official title: Effects of Diaphragmatic Breathing on Pain, Function, Balance and Quality of Life in Pregnant Women With Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Low Back Pain
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study was to investigate the effects of diaphragmatic breathing on pain, function, balance and quality of life in pregnant women with low back pain.

Detailed description: Individuals with pregnancy-related low back pain who present to the Obstetrics and Gynecology Clinic of İzmir Menemen State Hospital are identified as the study population. Patients meeting the eligibility criteria will be included in the study.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Pregnancy between 19-29 weeks
* Low back pain that started with pregnancy (at least 1 week; no previous history of low back pain)
* No treatment for the lumbar region or spine in the last 3 months

Exclusion Criteria:

* History of cardiovascular disease
* Multiple pregnancy
* Medical complications (e.g., bleeding, pre-eclampsia, placenta previa, etc.)
* Diagnosed cognitive disorders
* High-risk pregnancy
* History of abdominal and/or thoracic surgery

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Baseline, 6 weeks
measure: Oswestry Disability Index
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Timed up and go test
timeFrame: Baseline, 6 weeks
measure: The Single Leg Stance Test
timeFrame: Baseline, 6 weeks
measure: Quality of Life in Pregnancy Scale
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İzmir Katip Çelebi University
state: Çigli
Study officials:
References:
Clinical trial NCT03349944: Effect of Training Intensity on Health Outcomes in Diabetes
Official title: Effect of High Intensity Interval Training on Nuclear Orphan Receptor Expression and Adrenergic Signaling in Skeletal Muscle of Persons With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: exercise
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 45
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The project will investigate high intensity interval training on the glucose regulation in type 2 diabetic subjects compared to moderate continuous exercise.


Eligibility criteria: Inclusion Criteria:

Type 2 diabetes Age: 30-70 Non smokers (minimum the last 15 years) Inactive lifestyle (\<2 hours pr. week) BMI \<35 kg/m2

Exclusion Criteria:

Smoking Prior cardiavascular diseases Alcohol intake 14\> units pr. week.

Primary outcomes:
measure: HbA1c
timeFrame: From baseline measure to post test: 10 weeks
Secondary outcomes:
measure: Oral glucose tolerance test
timeFrame: From baseline measure to post test: 10 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
References:
citation: Baasch-Skytte T, Gunnarsson TP, Fiorenza M, Bangsbo J. Skeletal muscle proteins important for work capacity are altered with type 2 diabetes - Effect of 10-20-30 training. Physiol Rep. 2021 Jan;9(1):e14681. doi: 10.14814/phy2.14681.
Clinical trial NCT05155644: Safety of Therapeutic Step-down in Neuromyelitis Optica
Official title: Safety of Therapeutic Step-down in Neuromyelitis Optica
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromyelitis Optica
Keywords: Neuromyelitis Optica
NMO
multiple sclerosis (MS)
Iatrogeny.
Autoimmune diseases
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 947
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major patients who have received long-term treatment for NMO and with a prospectively diagnosed NMO using the 2015 NMO classification criteria (IPND)

Brief summary: Neuromyelitis Optica (NMO) is a neuroinflammatory disease related to multiple sclerosis (MS). It affects young subjects and causes a lot of handicap without treatment. Thus, aggressive treatments are frequently introduced early in the life of patients and maintained over the long term. A long duration of treatment exposes to iatrogenism. Therapeutic de-escalation trials in MS or other autoimmune diseases show rebound phenomena. In the NMO, there are no published data on the tolerance of desescalations to guide such strategies.


Eligibility criteria: Inclusion criteria:

* Major patients who have received long-term treatment for NMO
* Patients with a prospectively diagnosed NMO using the 2015 NMO classification criteria (IPND)
* Patients who retrospectively meet the classification criteria of the 2015 NMO (IPND)
* Patients who have not expressed their opposition, after information, to the reuse of their data for research purposes.

Exclusion criteria:

* Patient who expressed his opposition to participating in the study
* Lack of data on the assay of anti-AQP4 and anti-MOG antibodies
* Less than a year of taking a second-line treatment before the relay
* End of follow-up \<1 year following the transfer, this therefore includes patients whose transfer took place less than one year before the date of data extraction

Primary outcomes:
measure: Retrospective evaluation of the risk of rebound during therapeutic escalations in neuromyelitis optica (NMO)
timeFrame: Files analysed retrospectively from January 01, 2000 to December 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Neurologie - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de Neurologie - Hôpitaux Universitaires de Strasbourg
name: Jérôme DE SÈZE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01444144: Ankle Fracture Treatment in the Elderly
Official title: Ankle Fracture Treatment in the Elderly, at Risk Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Fracture
Keywords: Ankle
Fracture
Elderly
At-risk Population
Ankle Fracture in at-risk elderly population
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-09-30
Enrollment: 118
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At-risk population, at least 55 years of age at time of surgery receiving treatment for ankle fractures.

Brief summary: The purpose of this study is to track surgical outcomes and post-operative course in patients 55 years of age or older treated for ankle fractures.

Detailed description: This study seeks to describe and track surgical outcomes associated with the use of a minimally invasive surgical technique used to treat ankle fractures in at-risk patients 55 years of age or older

Eligibility criteria: Inclusion Criteria:

* at least 55 years of age at time of surgery
* receiving treatment for ankle fractures

Exclusion Criteria:

* none

Primary outcomes:
measure: Status of Fracture Union
timeFrame: Post-operatively until documentation of fracture healing, assessed up to seven months following surgery.
Secondary outcomes:
measure: Post-operative Complications
timeFrame: Post-operatively until documentation that complications resolved, assessed up to seven months following surgery.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF&Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida Department of Orthopaedics and Rehabilitation
name: Kalia K Sadasivan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03555344: Effect of Mantra on Hypertensive Patients
Official title: Immediate Effect of Mantra Chikitsa on Cardiovascular Parameters in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Blood Pressure
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Warwick Research Services
name: Swamigal Trust for Vedic Science, India
First posted: 2018-06-13
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Mantras are specialized energized sound or words, which are defined most important sound therapy in Vedic healing. Present study was undertaken to evaluate the immediate effect of specialized Mantra chant on cardiovascular parameters in high blood pressure patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosed and stable hypertension
* on regular medication

Exclusion Criteria:

* Individuals diagnosed with another lung disease,
* Have psychiatric, musculoskeletal or cardiovascular diseases,
* Being smokers
* Being pregnant

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: Change from baseline to half an hour
measure: Diastolic Blood Pressure
timeFrame: Change from baseline to half an hour
Secondary outcomes:
measure: Supine heart rate (HR)
timeFrame: Change from baseline to half an hour
Other outcomes:
Locations:
city: Jaipur
country: India
facility: NMP Medical Research Institute
state: Rajasthan
Study officials:
affiliation: Warwick Research Services
name: Neha Sharma, PhD
role: STUDY_DIRECTOR
affiliation: Swamigal Trust for Vedic Science, India
name: Ravishankar Ramanathan
role: PRINCIPAL_INVESTIGATOR
affiliation: NMP Medical Research Institute
name: Puneet Sharma
role: STUDY_CHAIR
References:
Clinical trial NCT06362044: A Study to Assess Frequency of Undetectable Minimal Residual Disease (uMRD) in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Venetoclax Tablets ± Intravenously (IV) Infused Rituximab in Routine Clinical Practice in Japan
Official title: The Frequency of uMRD in Japanese Patients With CLL After 24 Months of Treatment With Venetoclax±Rituximab in the 2L+ in the Real-World Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
CLL
Venetoclax
Rituximab
ABT-199
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants diagnosed with chronic lymphocytic leukemia (CLL) treated with Venetoclax±Rituximab and attend to a regular follow up visit at a Japanese participating hospital will be eligible to participate in the study.

Brief summary: Most cases of Chronic lymphocytic leukemia (CLL) remain an incurable disease with the goal of therapy being to improve quality of life and to prolong survival. This study will evaluate the participant's related outcomes and experience of CLL in adult participants who are treated in the Japan.

Study participants will receive oral treatments of Venetoclax±Rituximab for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments Venetoclax±Rituximab will be enrolled. Around 89 participants will be enrolled in the study in sites in Japan.

Participants will receive oral venetoclax tablets ± intravenously (IV) infused rituximab treatments for CLL according to the approved local label. The overall study duration will be 27 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with relapsed/refractory (2 Line \[2L\]+) chronic lymphocytic leukemia (CLL) in Japan based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria at the time of informed consent (IC).
* Treatment with Venetoclax±Rituximab for 24 months who are not treated with any other concurrent CLL treatment.
* Expected to visit the hospital at + 3 months after treatment with Venetoclax±Rituximab for 24 months.

Exclusion Criteria:

* No data on information on the start and end dates or continuation of treatment with Venetoclax.
* Participating in other clinical trials.

Primary outcomes:
measure: Percentage of Participants with Undetectable Minimal Residual Disease (uMRD)
timeFrame: Up to 27 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 265970
state: Chiba
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: