louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02031211: TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial
Official title: Etanercept for the Treatment of Chronic Regional Pain Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: CRPS
Chronic Regional Pain Syndrome
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studying the effects of Etanercept (an anti-Tumor Necrosis Factor alpha) on early Chronic Regional Pain Syndrome (CRPS). Our hypothesis is that Etanercept will improve patient symptoms if given in early CRPS.


Eligibility criteria: Inclusion Criteria:

1. Female pediatric Chronic Regional Pain Syndrome (CRPS) patients with unilateral CRPS of the lower extremity, ages 10-17 years of age.
2. Patients must meet CRPS Type I diagnostic criteria and have current evidence of edema, and a temperature difference between the affected and contralateral limb ≥1.0°C.
3. Duration of symptoms less than 4 months.

Exclusion Criteria:

1. Active malignancy or history of malignancy.
2. Active infection.
3. History of Tuberculosis (TB) or TB exposure.
4. Pregnancy.
5. Concomitant disease causing immunocompromise.
6. Concomitant autoimmune disease such as rheumatoid arthritis, psoriasis, ankylosing spondylitis or Crohn's Disease.
7. Poorly controlled psychiatric disease including anxiety, depression or attention deficit hyperactivity disorder.
8. Hepatic or renal impairment as indicated by serum transaminases and/or creatinine ≥ 150% normal value for age.
9. Evidence of or history of demyelinating disease.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Adolescent Pediatric Pain Tool
timeFrame: At end of each week of treatment
measure: Skin Temperature and Volume of Affected Limb
timeFrame: At beginning and end of study
measure: Hospital Anxiety and Depression Scale
timeFrame: Beginning and end of study
measure: Sleep Disturbance Scale for Children
timeFrame: Beginning and end of the study
measure: Sleep pattern and quality
timeFrame: Daily
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT00276211: Diffusion Weighted MRI for Lymphnodes in the Axilla
Official title: Diffusionsvægtet MR Skanning Med Henblik på axillære Lymfeknudemetastaser Hos Patienter Med primær Mammacancer - et Pilotstudie
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: MRI diffusion mamma cancer
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2006-01-13
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: This study is going to compare diffusionweigthed MRI scanning to the result of surgey in patients with metastasis from brestcancer in the axilla


Eligibility criteria: Inclusion Criteria:

Newly diagnosed breast cancer patients, where ultrasound and cytologi has proved one or more malignant lymphnodes in the axilla.

Exclusion Criteria:

Pacemaker metal in the body claustrphobia psychiatry patients pregnancy age below 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Radiology, Herlev University Hospital
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Jakob M Møller, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02705911: TeleRehabilitation in Hypertension
Official title: Isometric Handgrip Exercise: a New Non-pharmacological Tool in the Management of High Blood Pressure?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Pre-hypertension
Healthy
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2016-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this RCT which will be performed in 60 healthy adults is I. To assess the training effects of 8 weeks of isometric handgrip exercise on BP; and to test whether it yields at least similar effects on BP compared to current exercise recommendations.

II. To assess whether isometric handgrip training yields larger BP reductions beyond the supervised training period at 6 months of follow-up.

III. To determine whether changes in BP following acute exercise and chronic training can be explained by changes in important physiological mechanisms known to mediate or to be associated with BP?


Eligibility criteria: Inclusion Criteria:

* not physically active (\< 3 hours of moderate to high levels of PA/week) low cardiovascular risk according to current guidelines (Mancia et al J Hypertens 2013) will be recruited through advertisements. The latter is defined as:
* \>115 mmHg \< systolic BP \< 139 mmHg and/or 75 mmHg\< diastolic BP\<90mmHg in the presence of 0 to a maximum of three other cardiovascular risk factors, excluding diabetes Or
* 139 mmHg \< systolic BP \< 160 mmHg and/or 90 mmHg\<DBP\< 100 mmHg in the absence of other cardiovascular risk factors

Exclusion Criteria:

* current smoker
* pregnancy
* presence of other cardiovascular disease, pulmonary disease or metabolic disease
* inability to perform a standard exercise program due to mental/physical disability.
* use of antihypertensive drugs

Primary outcomes:
measure: change in office blood pressure at 8 weeks of follow-up
timeFrame: 8 weeks - 6 months
Secondary outcomes:
measure: change in exercise tolerance (peakVO2 in ml/min/kg) at 8 weeks of follow-up
timeFrame: 8 weeks - 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References:
Clinical trial NCT03021811: EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management
Official title: EUREKA Italy - The Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management: a Reproducibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Diabetic Foot Ulcer
Pressure Ulcer
Lead sponsor: KLOX Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-16
Enrollment: 100
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: Multi-center, prospective, interventional, uncontrolled open-label study evaluating the real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg ulcers, diabetic foot ulcers, pressure ulcers).


Eligibility criteria: Inclusion Criteria:

* Signed and dated written informed consent form;
* Adult patient (at least 18 years old) having received a diagnosis of venous leg ulcer, diabetic foot ulcer or pressure ulcer by the Investigator;
* The treating physician (investigator) believes the KLOX LumiHeal BioPhotonic System would be an appropriate option;
* Both male and female patients must be willing to adhere to a medically-accepted birth control method during the course of the study;
* Willingness to comply with study requirements (visits, treatments, etc.).

Exclusion Criteria:

* Female pregnant patient (by medical history or as ascertained by a pregnancy test);
* Breast-feeding female patient;
* Patients taking drugs/products (e.g., methotrexate, chemotherapy agents) or with conditions (e.g., porphyria) known to induce severe photosensitivity reactions;
* Patients with known skin hypersensitivity.

Primary outcomes:
measure: Adverse events, Serious Adverse Events and Device Incidents
timeFrame: Up to 34 weeks
measure: Rate of complete wound closure
timeFrame: Up to 34 weeks
Secondary outcomes:
measure: Wound area reduction over time
timeFrame: Up to 34 weeks
measure: Time to complete wound closure
timeFrame: Up to 34 weeks
measure: Incidence of wound breakdown, following wound closure
timeFrame: Up to 34 weeks
measure: Ease of use by healthcare professionals (questionnaire)
timeFrame: Up to 34 weeks
measure: Impact of treatment on Health-related Quality of Life (CWIS questionnaire)
timeFrame: Up to 34 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04366011: Efficacy and Mechanisms of Psychosocial Treatments for Panic Disorder
Official title: Efficacy and Mechanisms of Psychosocial Treatments for Panic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to a) determine the comparative efficacy of the brief capnometry-assisted respiratory therapy (CART) and standard cognitive behavioural therapy (CBT), and b) to determine moderators and mediators.

With the data collected from the study, the investigators will test the following hypotheses: (a) CART will be as effective in treating PD/A as CBT, albeit in shorter time, b) patients with greater respiratory dysregulations, especially hyperventilation, at pretreatment will benefit more from CART, whereas patients with greater cognitive dysregulation will benefit more from CBT. CART, but not CBT, will result in reversal of hyperventilation.


Eligibility criteria: Inclusion Criteria:

1. A current DSM-IV (Diagnostic and Statistical Manual IV) diagnosis of panic disorder with or without agoraphobia that is designated by the patient as the most important source of current distress
2. Patients must be willing to engage in exposure to fearful situations and sensations.

Exclusion Criteria:

Diagnostic Exclusion Criteria:

1) A history of bipolar disorder, psychosis or delusional disorders (as evaluated by the SCID-IV-L (Structured Clinical Interview for the DSM IV) screening questions), substance abuse or dependence or alcohol abuse or dependence (other than nicotine in the last 3 months)

Medical exclusion factors:

1. Patients with severe unstable medical illness, clinically significant laboratory findings, or serious medical illness for which hospitalization may be likely within the next three months
2. Patients with a history of seizures, angina, myocardial infarction, congestive heart failure, clinically significant arrhythmias, transient ischemic attacks, cerebrovascular accidents, diabetes mellitus, significant asthma, emphysema, or chronic obstructive pulmonary disease

Primary outcomes:
measure: Panic Disorder Symptoms Severity change
timeFrame: During treatment (weeks 1- 12) and 2-months and 6-months follow-ups
Secondary outcomes:
measure: End-tidal PCO2 (carbon dioxide partial pressure) change
timeFrame: during treatment (weeks 1-12), 2 -and 6 months follow-up
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Stress, Anxiety, and Chronic Disease Research Program, Southern Methodist University
state: Texas
Study officials:
affiliation: Southern Methodist University
name: Alicia E Meuret, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05216211: The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients
Official title: The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Intracranial Hypertension
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Caudal epidural block has been a widely used regional anesthesia method, especially in pediatric surgery, to provide intraoperative and postoperative analgesia. Studies on non-invasive methods used for intracranial pressure measurement have shown that optic nerve sheath diameter is related to intracranial pressure. Optic nerve sheath diameter measurement has high diagnostic accuracy for detecting increased intracranial pressure in children. The aim of the study is to investigate the effect of the caudal block on optic nerve sheath diameter in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* circumcision,
* inguinal hernia,
* undescended testis,
* hydrocele operation

Exclusion Criteria:

* neurological or spinal anomaly,
* coagulopathy
* allergy to local anesthetics,
* local infection in the area to be intervention,
* with increased intracranial pressure
* children with any ophthalmic pathology

Primary outcomes:
measure: Optic Nerve Diameter
timeFrame: First minute
measure: Optic Nerve Diameter
timeFrame: 5th minutes
measure: Optic Nerve Diameter
timeFrame: 15th minutes
measure: Optic Nerve Diameter
timeFrame: 30th minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University School of Medicine
state: Yakutiye
Study officials:
References:
Clinical trial NCT05036811: HIV and Inflammatory or Autoimmune Disease: Rare Patients, Many Questions (MAIVIH)
Official title: HIV and Inflammatory or Autoimmune Disease: Rare Patients, Many Questions (MAIVIH)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hiv
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HIV and an inflammatory or autoimmune disease

Brief summary: Follow-up registry of patients living with HIV who also have various inflammatory and autoimmune pathologies that may require immunosuppressive treatment.


Eligibility criteria: Inclusion Criteria:

* Patient living with HIV
* Carrier of one or more of the following diseases:

Sarcoidosis Multiple sclerosis Myasthenia gravis Crohn's disease Hemorrhagic rectocolitis Autoimmune hepatitis Arthropathic psoriasis Still's disease, other rheumatoid arthritides, juvenile polyarthritides, Rheumatoid arthritis Vasculitides: periarteritis nodosa and related conditions, other necrotizing vasculopathies (periarteritis nodosa, juvenile periarteritis, Churg-Strauss disease, polyangiitis, Kawasaki disease, Horton's disease, Wegener's disease, thrombotic microangiopathy, Takayashu syndrome, Good-Pasture's syndrome, thrombocytopenic purpura) Lupus Polymyositis or dermatopolymyositis Connectivitis (Behcet's disease, Gougerot-Sjöogren syndrome) Inflammatory spondyloarthropathies (APS, spondyloarthritis, other spondyloarthropathies)

Exclusion Criteria:

* Opposition of the person
* Minor patients
* Patients under judicial protection

Primary outcomes:
measure: Number of patients living with HIV who have an inflammatory or autoimmune disease
timeFrame: At the end of the study an average of 18 months
Secondary outcomes:
measure: Number of patients on immunosuppressive treatment,
timeFrame: At the end of the study an average of 18 months
measure: Occurrence of infectious complications
timeFrame: At the end of the study an average of 18 months
measure: Number of patients on remission
timeFrame: At the end of the study an average of 18 months
measure: Evolution of CD4 and HIV viral load
timeFrame: At the end of the study an average of 18 months
Other outcomes:
Locations:
city: Tourcoing
country: France
facility: CH Tourcoing
Study officials:
affiliation: CH TOURCOING
name: Nathalie VIGET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05328011: Targeting Microbiota in Female Overactive Bladder Syndrome
Official title: Targeting Microbiota in Female Overactive Bladder Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbiota
Urinary Bladder, Overactive
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients bothering for OAB, who present themselves at the urogynecological outpatient clinic, are considered to be eligible for inclusion in this study.

Brief summary: The aim of this study is to compare the urinary viral microbiome and bacterial microbiome between overactive bladder syndrome (OAB) patients and healthy controls in order to determine a possible alteration in the urinary microbiome which may predispose women for OAB, and also in order to determine a possible influence of the urinary viral microbiome on the urinary bacterial microbiome which may predispose the individual to OAB. Furthermore, we aim to compare the urinary bacterial microbiome to the vaginal, rectal, urethral and salivary bacterial microbiome within the same individual and between the two groups in order to determine a possible route of colonization of the urinary bladder.


Eligibility criteria: Inclusion Criteria (case group):

* symptoms of overactive bladder (urgency with or without urinary leakage, usually with frequency and nocturia)

Exclusion Criteria (case group):

* Pregnant or lactating females

  * Neurological conditions (such as MS, Parkinson, spinal cord injury, stroke..)
  * Pelvic Organ Prolapse (stage ≥ 3)
  * Lower Urinary Tract surgery within past 6 months
  * Known history of interstitial cystitis or pain associated with OAB
  * Recurrent urinary tract infections \> 3/year
  * Acute urinary tract infection
  * Urinary retention (with or without required self- catheterization)
  * Stress urinary incontinence or mixed urinary incontinence
  * Bladder cancer
  * Renal insufficiency
  * Urinary tract stones

Inclusion Criteria (control group):

without symptoms of overactive bladder or any other form of lower urinary tract symptoms

* Age-matched to case group (+/- 5 years)
* BMI-matched to case group (18,5- 24,9 kg/m2 normal weight; 25- 29,9 kg/m2 overweight; 30- 34,9 kg/m2 obesity grade I)

Exclusion criteria (control group):

As case group plus any form of lower urinary tract symptoms including OAB

Primary outcomes:
measure: urinary bacterial and viral microbiome
timeFrame: 1 day
Secondary outcomes:
measure: bacterial and viral microbiome of vagina, urethra, feces and oral cavity
timeFrame: 1 day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT01389011: Perfusion Index (PI) and Pleth Variability Index (PVI) in Patients With Interscalene Blocks in Orthopedic Surgery
Official title: An Evaluation of PI and PVI (Masimo) in Patients With Interscalene Blocks in Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perfusion Index and Pleth Variability Index
Interscalene Blocks
Orthopedic Surgery
Keywords: PI
PVI
Interscalene block
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for surgery of the shoulder and the upper arm.

Brief summary: The purpose of this study is to:

1. To describe effects of interscalene nerve blocks on perfusion index (PI) and pleth variability index (PVI) (Radical 7, Masimo Cooperation, Irvine, CA) before and after induction of general anesthesia.
2. To compare effects of fluid-bolusing on PI and PVI of the anesthetized and non-anesthetized limb.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for shoulder or upper arm surgery
* ASA 1-3
* written informed consent
* approval from the local ethics committee

Exclusion Criteria:

* arrhythmia
* patients suffering from severe vascular disease, coronary artery (CCS IV) disease
* anaemia (haemoglobin \< 7mg/dl)
* patients in whom a tidal volume of 8ml/kg cannot be delivered safely

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology, Johannes Gutenberg-University Mainz
state: Rheinland-Pfalz
Study officials:
References:
citation: Sebastiani A, Philippi L, Boehme S, Closhen D, Schmidtmann I, Scherhag A, Markstaller K, Engelhard K, Pestel G. Perfusion index and plethysmographic variability index in patients with interscalene nerve catheters. Can J Anaesth. 2012 Dec;59(12):1095-101. doi: 10.1007/s12630-012-9796-3. Epub 2012 Oct 2.
Clinical trial NCT05794711: Intraoperative Frozen Section Pathology to Guide Surgical Treatment for Lung Adenocarcinoma (ECTOP-1015)
Official title: Concordance Between Intraoperative Frozen Section Pathology and Postoperative Paraffin-embedded Pathology in Diagnosing the IASLC Grade of Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Adenocarcinoma
Surgical Procedure, Unspecified
Pathology
Keywords: Intraoperative frozen section pathology
Surgical treatment
Lung adenocarcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 1063
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical stage T1N0M0 lung adenocarcinoma patients who are going to undergo surgical resection.

Brief summary: This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1015). The goal of this clinical trial is to confirm the concordance rate between intra-operative frozen section pathological diagnosis and post-operative paraffin embedded pathological diagnosis, and use this result to guide surgical treatment for early stage (cT1N0M0) lung adenocarcinomas.


Eligibility criteria: Inclusion Criteria:

* Patients who sign the informed consent form and are willing to complete the study according to the study protocol;
* No previous history of cancer or pulmonary surgery;
* Solitary lesions or multiple lesions with only one not manifesting as pure ground-glass opacity (GGO) on CT scan;
* Peripheral clinical T1N0M0 patients that are eligible for surgery;
* Non-small cell lung cancer is pathologically diagnosed before or at surgery;
* No radiation therapy or chemotherapy before surgery.

Exclusion Criteria:

* Patients with clinical stages other than T1N0M0;
* The lesion cannot be completely resected;
* Previous history of cancer;
* Patients having received radiation therapy or chemotherapy.

Primary outcomes:
measure: Concordance rate
timeFrame: 2 years
Secondary outcomes:
measure: Concordance rate
timeFrame: 2 years
measure: Concordance rate
timeFrame: 2 years
measure: Concordance rate
timeFrame: 2 years
measure: Recurrence-free survival (RFS)
timeFrame: 5 years
measure: Overall survival (OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Center
state: Shanghai
Study officials:
References: