louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06903637: Identification of Priority Clinical Variables in Rehabilitation of Lower Extremity Amputation
Official title: Personalized Rehabilitation for Lower Limb Amputation: the Role of Hierarchical Cluster Analysis in Identifying Priority Clinical Variables
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Limb Amputation
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2025-03-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with lower limb amputation

Brief summary: Background: Identifying which variables influence the personalized rehabilitation of patients with lower limb amputation and understanding their interrelationships optimizes resource allocation. This study aims to identify priority variables that influence clinical follow-up using hierarchical cluster analysis (HCA).

Methods: Data on 26 variables were collected from 70 patients diagnosed with lower limb amputation; (age, gender, body mass index(BMI), marital status, education, occupation, smoking and alcohol use, amputation - level/duration/lateral/etiology, prosthesis type, type of additional prosthesis, Kellgren Lawrence Classification(KLC) - right/left knee, Houghton Scale(HS), Timed-Up\&Go(TUG) Test, Trinity Amputation and Prosthesis Experience Scales(TAPES)-prosthesis satisfaction/psychosocial adjustment/activity limitation, Using the 12-item Short Form Health Questionnaire(SF-12)-physical score(PS)/mental score(MS), Locomotor Capabilities Index-5(LCI-5), Medicare Functional Classification Level(MFCL) and Falls Efficacy Scale(FES)). From the collected data, dendrograms were formed by using HCA with Ward linkage method.


Eligibility criteria: Inclusion Criteria:

1. having been diagnosis of lower limb amputation,
2. sufficient perceptual acuity to complete the tasks,
3. no head injury within the last 2 years, and
4. being a native Turkish speaker.

Exclusion Criteria:

1. being unable to complete the study,
2. having a history of severe psychiatric illness.

Primary outcomes:
measure: Houghton Scale
timeFrame: 10 minutes
measure: Timed Up and Go (TUG) Test
timeFrame: 5 minutes
measure: Trinity Amputation and Prosthesis Experience Scales
timeFrame: 10 minutes
measure: Short-Form Health Survey score
timeFrame: 10 minutes
measure: The Locomotor Capabilities Index-5
timeFrame: 10 minutes
measure: Medicare Functional Classification Level
timeFrame: 10 minutes
measure: Falls Efficacy Scale
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University Hospital
Study officials:
References:
citation: Wade DT. What is rehabilitation? An empirical investigation leading to an evidence-based description. Clin Rehabil. 2020 May;34(5):571-583. doi: 10.1177/0269215520905112. Epub 2020 Feb 10.
Clinical trial NCT03140137: Immune Checkpoint Inhibitors and Pre-existing Autoimmune Diseases
Official title: Retrospective Observational Study on the Safety of Immune Checkpoint Inhibitors in the Treatment of Advanced Melanoma and Lung Cancers in Patients With Pre-Existing Autoimmune Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Diseases
Advanced Cancer
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a pre-existing autoimmune disease who received immune checkpoint inhibitors for the treatment of an advanced cancer in clinical practice.

Brief summary: The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing autoimmune conditions. This retrospective nation-wide study will assess their tolerance in patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors for an advanced cancer in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Pre-existing autoimmune disease as diagnosed by the physician
* Immune checkpoint inhibitor therapy for an advanced cancer

Exclusion Criteria:

* Auto-immune disease developed only after the start of the immune checkpoint inhibitor therapy
* Absence of follow-up

Primary outcomes:
measure: Autoimmune disease flare
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Other immune/inflammatory complications
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: AIX en PROVENCE
country: France
facility: CH d'AIX
city: Dijon
country: France
facility: CHU de DIJON
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Le Mans
country: France
facility: Ch Le Mans
city: Macon
country: France
facility: CH de MACON
Study officials:
affiliation: CHRU de Brest
name: Divi CORNEC
role: STUDY_DIRECTOR
References:
Clinical trial NCT02122237: Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
Official title: Cathodal Transcranial Direct Current Stimulation in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Migraine
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cathodal tDCS decreases the excitability of the cerebral cortex and its daily application during intercritical phase, may have a therapeutic effect in chronic migraine.

Detailed description: During the interictal phase, the cerebral cortex is characterised by a hyperresponsiveness to repeated sensory stimuli, manifested by a lack of habituation or adaptation of cortical responses. Lack of habituation has been shown in the visual cortex in studies of visual evoked potentials (VEP) during the interictal period and it is possibly explained by a reduction in the cortical pre-activation level due to thalamo-cortical dysrhythmia. Just before and during the migraine attack, cortical reactivity changes drastically: habituation is restored and the amplitude increases. In chronic migraine (headache occurring on 15 or more days per month for more than 3 months with features of migraine headache on at least 8 days per month), VEPs habituate normally like those recorded during attacks of episodic migraine, but have in addition an increased amplitude in the 1st block of responses. Chronic migraine was therefore compared to a "never ending migraine attack" accompanied by cortical hypersensitivity.

In this study the investigators aim to demonstrate that cathodal tDCS over the visual cortex with simultaneous anodal tDCS over the left dorsolateral prefrontal cortex is able: 1) to reduce cortical hypersensitivity and habituation as assessed by VEPs and contact heat evoked nociceptive potentials (CHEPS), as well as to decrease pain perception assessed by quantitative sensory testing (QST) and the nociceptive blink reflex (nBR); 2) to decrease headache and migraine frequency.

Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse

Exclusion Criteria:

* others diseases or contraindications to tDCS (epilepsy, pacemaker, metal prosthetics)

Primary outcomes:
measure: Migraine frequency
timeFrame: 6 months
Secondary outcomes:
measure: Migraine intensity
timeFrame: 6 months
measure: Acute medication intake
timeFrame: 6 months
measure: Attack duration
timeFrame: 6 months
measure: Scores at psychological scales
timeFrame: 6 months
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Roberta Baschi
Study officials:
affiliation: University of Liege
name: Delphine Magis, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Liege
name: Jean Schoenen, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05304637: Usability, Immediate, and 30 Day Effect of External Neuromodulation With iTEAR100 Generation 2 in Dry Eye Patients
Official title: Usability, Immediate, and 30 Day Effect of External Neuromodulation With iTEAR100 Generation 2 in Dry Eye Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Olympic Ophthalmics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open labe therapeutic study
Primary purpose: TREATMENT

Brief summary: iTEAR generation 2 will be supplied t eligible subjects at Day 0. At Day 30, symptom questionnaires and ophthalmic exam will be performed.

Detailed description: TEAR generation 2 will be supplied t eligible subjects at Day 0. At Day 30, symptom questionnaires and ophthalmic exam will be performed. At both exam days, a Schirmer test before and after will be performed as well as parameters which indicate immediate effect of treatment and treatment over the 30 days.

Eligibility criteria: Inclusion Criteria:

* Dry eye

Exclusion Criteria:

* unable to read consent
* investigator discretion

Primary outcomes:
measure: Schirmer score
timeFrame: within 5 minutes of stimulation
Secondary outcomes:
measure: Symptom Scores
timeFrame: 30 days
Other outcomes:
Locations:
city: Issaquah
country: United States
facility: Olympic Ophthalmics
state: Washington
city: Seattle
country: United States
facility: Periman Eye Institute
state: Washington
Study officials:
References:
Clinical trial NCT02113852: Study of Blood, Tumor and Adjacent Normal Tissue Samples From Chinese Smoking Induced Lung Cancer Patients
Official title: Study of Blood, Tumor and Adjacent Normal Tissue Samples From Chinese Smoking Induced Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: Non small cell Lung Cancer
Heavy smokers
Treatment naive patients
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study aims to collect approximately 250 smoking induced lung cancer(NSCLC) samples.Approximately 200 cases of treatment naive samples will be required. Samples will be collected mainly from the investigational sites in Guangzhou, Shanghai and Beijing that have expertise in lung cancer diagnosis.

Brief summary: This is an epidemiological,multicenter study of genomic and expression profiles of patients with newly diagnosed NSCLC.Two hundred and fifty NSCLC patients who fulfill the criteria are to be recruited by investigational sites.Approximately 100 of them will be from retrospectively collected samples with detailed clinical and 2-year follow-up information after surgeries.The demographics,cancer/adjacent normal tissue and matched blood sample will be collected after the patient had provided informed consent.All tissue samples will be analyzed for somatic mutations by exome deep sequencing,mRNA expression profiling by RNA sequencing and chromosome copy number variation by SNP array at the designated laboratories.

Detailed description: The 2-year follow-up information of all enrolled patients will be collected every 6 months.

Eligibility criteria: Inclusion Criteria:

1. Provision of written informed consent.
2. Male or female aged≥18 years.
3. .Histological or cytologically confirmed primary NSCLC，including histological subtypes:adenocarcinoma,squamous cell carcinoma and large cell carcinoma etc.
4. .Provision of surgical specimen and blood sample.The retrospective samples will be collected between 2006and 2012 from the bio-bank.
5. Patients must be willing to provide detailed clinical information (sex,age,geographic place,tumor stage,grade,size,smoking history,treatment history if any and outcome data).
6. Heavy smokers(defined as having smoked 20 pack-years or more).
7. Treatment naive patients:No prior chemotherapy,biological,immunological therapy or radical radiotherapy is permitted.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: whole genome copy number variation in NSCLC patients
timeFrame: 2 years
Secondary outcomes:
measure: Establish more effective therapy for lung cancer treatment in the future
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
name: Yi-Long Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02850952: Rehab MATRIX: Impact of a Nursing-Led Acuity Algorithm on Patient Safety and Healthcare Quality
Official title: Rehab MATRIX: Impact of a Nursing-Led Acuity Algorithm on Patient Safety and Healthcare Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Nurse-Patient Relations
Satisfaction
Patient Fall
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Memorial Hermann Texas Medical Center
name: Memorial Hermann Health System
First posted: 2016-08-01
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine whether implementation of Rehab MATRIX will improve patient safety, patient satisfaction and nursing indices.

Detailed description: The provision of efficient and conscientious nursing care is at the forefront of health care quality. Unfortunately, a lack of objectivity in the assignment of patients to nurses can lead to inequalities of care. Such inequalities translate to poor patient outcomes and diminished patient satisfaction. Furthermore, staff attrition related to nursing fatigue increases the cost of care due to a reliance on supplemental nurses. Rehab MATRIX is a patient assignment tool that objectively categorizes patients undergoing inpatient rehabilitation based on nurse identified acuity variables.

Eligibility criteria: Inclusion Criteria:

* Rehabilitation Nursing Staff within Six Study Centers
* Patient hospitalized within the Rehabilitation Unit during the study period

Exclusion Criteria:

* Other Nursing Staff
* Patients hospitalized on non-rehabilitation units

Primary outcomes:
measure: Change in the number of falls per 1000 patient days (falls per 100 patient days is a standardized proportion)
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
Secondary outcomes:
measure: Change in Patient Satisfaction as assessed by the Press Ganey Survey
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
measure: Change in Nursing Fatigue as assessed by number of unexcused nurse absences
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
measure: Change in Nursing Satisfaction as assessed by a survey
timeFrame: Two weeks prior to initiation, 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nneka L Ifejika, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ifejika NL, Okpala MN, Moser HA, Watkins JN, Noser EA. Rehab MATRIX: Content Validity of a Nursing-Led Patient Assignment Algorithm. J Neurosci Nurs. 2019 Feb;51(1):33-36. doi: 10.1097/JNN.0000000000000418.
Clinical trial NCT06333652: Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
Official title: Clinical Trial on the Use of Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Preeclampsia
Keywords: Hemolysis
Elevated Liver enzymes
Low Platelets
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome.


Eligibility criteria: Inclusion Criteria:

* Individuals with \< 34 0/7 weeks of gestation.
* Individuals with severe preeclampsia or HELLP features.

Exclusion Criteria:

* Pregnant female patients presenting with disseminated intravascular coagulopathy (DIC).
* Individuals with non-reassuring fetal status requiring delivery, non-viable fetuses, previable pregnancy (\<23 0/7 weeks gestation), stroke, in utero fetal demise, known atypical hemolytic uremic syndrome, familial or acquired thrombocytopenia purpura, paroxysmal nocturnal hemoglobinuria, allergy to Ravulizumab, inability or unwillingness to sign informed consent.

Primary outcomes:
measure: Alternative Complement Pathway Biomarkers at time of delivery
timeFrame: Baseline
Secondary outcomes:
measure: Pregnancy duration
timeFrame: Approximately 40 weeks
measure: Clinical biomarkers of severe features of preeclampsia and HELLP syndrome
timeFrame: 72 hours after Ravulizumab infusion
measure: Hospitalization length in the postpartum period
timeFrame: Approximately 3-5 days, it may vary
measure: Meningococcal infection after use of ravulizumab
timeFrame: 72 hours up to 3 weeks after Ravulizumab infusion
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Maria Lourdes Gonzalez Suarez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03295552: Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC
Official title: Decitabine Plus Carboplatin in the Treatment of Metastatic Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Neoplasm
Keywords: decitabine
triple negative breast cancer
carboplatin
metastatic
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC


Eligibility criteria: Inclusion Criteria:

* Female aged between 18 years and 70 years old.
* Pathologically confirmed metastatic triple negative breast cancer (TNBC). Paraffin-embedded tissue were available from metastatic or primary sites to confirm its TNBC status or for further translational research. TNBC was defined as ER-, PR-, and HER2-.
* Metastatic TNBC should not be treated with more than 1-line for metastatic disease.
* Patients can not be treated with carboplatin in the metastatic setting.
* For patients received carboplatin treatment in the adjuvant setting, they should have at least one year disease interval between last dosage of carboplatin and trial recruiting.
* Patients had at least one measurable lesion according to RECIST criteria version 1.1.
* ECOG Performance Status (PS) of 0-1.
* Adequate liver and renal organ function.
* Dated and signed IEC/IRB-approved informed consent.

Exclusion Criteria:

* More than 1 one therapy for metastatic TNBC, Patients may receive bisphosphonates and other therapies to treat bone metastases.
* Less than four weeks since last radiotherapy.
* Pregnancy or lactation or unwillingness to use adequate method of birth control.
* Active or uncontrolled infection.
* Hypersensitivity to carboplatin or decitabine
* Male breast cancer.
* Treated with any DNA demethylating agents
* Young patients with pregnancy or lactation or unwillingness to use adequate method of birth control.

Primary outcomes:
measure: Overall response rate
timeFrame: At the end of Cycle 6 (each cycle is 21 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine
name: Kunwei Shen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital, Shanghai Jiaotong Univeristy School of Medicine
name: Min Lu, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02037152: Smartphone-based Mindfulness Training for Chronic Pain
Official title: Smartphone-based Mindfulness Training for Chronic Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Mobile applications
Mindfulness
Meditation
Telemedicine
Cellular phone
Pain Management
Therapy, computer-assisted
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 0
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: The purpose of this study is to test a smartphone-based mindfulness training program for chronic pain. Research participants use a 20 minute app-guided audio program six days per week. The study hypothesis is that training in this technique over a period of four weeks will reduce pain interference with daily life activities. This study does not require any travel or in-person contact with research staff-- all elements of the study are completed on the participant's smartphone.

Detailed description: This is a randomized, waitlist controlled trial. Smartphone users who download the research app complete an electronic informed consent before the app content is made available. Subjects meeting inclusion criteria are then prompted to complete baseline questionnaires. Submission of questionaires triggers randomization to one of two groups-- active treatment or waitlist. Subjects have equal chance of entering either group.

The active treatment group is instructed to use the app-guided "body scan" exercise daily for six days per week. The waitlist group is instructed that the research intervention will be made available to them in four weeks time. On a weekly basis, all subjects complete a Brief Pain Inventory scale. At the end of four weeks, subjects again complete a Brief Pain Inventory as well as the questionnaires measuring secondary outcomes. Upon completion of the control condition, waitlist subjects are invited to begin using the "body scan" exercise as described above. From this point forward, subjects receive the same protocol as the active treatment group. This study involves no face-to-face contact between participants and study investigators/staff.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Pain duration at least 3 months
* Access to smartphone

Exclusion Criteria:

* Pain from active cancer
* Pain from active cardiac disease

Primary outcomes:
measure: Pain functional interference index
timeFrame: 4 weeks
Secondary outcomes:
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: Ida Sim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: