louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01689922: The Effectiveness of Anti-Gravity Treadmill Training
Official title: The Effectiveness of Anti-Gravity Treadmill Training in Patients After Lumbar Microdiscectomy and Fusion Surgeries
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lumbar Degenerative Disc Disease
Lead sponsor: Justin Parker Neurological Institute
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing one-level microdiscectomy or fusion surgeries

Brief summary: The primary objective of this study is to compare the effectiveness of standard for our practice postoperative physical therapy (PT) program to a PT program that incorporates lower body positive pressure (LBPP) treadmill training for the patients after lumbar discectomy and fusion surgeries.

Detailed description: A prospective, randomized, parallel group controlled clinical study is proposed. The patients will be divided into the two study groups according to the surgical procedure:

1. patients undergoing one-level microdiscectomy for lumbar herniated disc
2. patients undergoing one-level lumbar fusion for degenerative disc disease without notable spinal stenosis.

Each group will consist of 60 patients (see sample size calculations below) who will be randomized into the two equal groups to undergo:

1. Standard postoperative rehabilitation program
2. Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training

Eligibility criteria: Inclusion Criteria:

* Adults between 18 and 65 years old
* Willing and able to comply with protocol and PT requirements
* Patients with primarily radicular and back pain due to degenerative disc disease requiring one-level discectomy for herniated disc or lumbar fusion between L2 and S1
* Willing and able to sign a study specific informed consent

Exclusion Criteria:

* Require more than one-level surgery
* No previous lumbar surgery
* Any ongoing health condition that would make it difficult to adhere to postoperative PT requirements
* Peri-operative or post-operative complications (infection, pneumonia, nerve injury, dural tear, etc.) that would constraint or delay the ability to participate in postoperative PT
* BMI greater than 40
* Active local or systemic infection

Primary outcomes:
measure: Oswestry Disability Questionnaire
timeFrame: 24 months
Secondary outcomes:
measure: Patient Global Outcome Ratings and Health Quality Improvement
timeFrame: 24 months
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Boulder Neurosurgical Associates
state: Colorado
Study officials:
affiliation: Boulder Neurosurgical Associates
name: Alan T Villavicencio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01558622: Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication
Official title: Intraoperative Use of Dexketoprofen Trometamol, Tramadol Hcl, Pethidine Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Laparoscopic Nissen Fundoplication
Keywords: postoperative analgesia
dexketoprofen trometamol
tramadol hydrochloride
pethidine
laparoscopic Nissen fundoplication
Lead sponsor: Kavaklıdere Umut Hospital
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic Nissen fundoplication.


Eligibility criteria: Inclusion Criteria:

* 18-60 years old ASA I-II patients
* Clinical diagnosis of gastroesophageal reflux patients

Exclusion Criteria:

* Allergic reactions to NSAIDs or opioid analgesics
* Body mass index exceeding 35
* Pregnancy

Primary outcomes:
measure: Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35
timeFrame: postoperative 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Kavaklidere Umut Hospital
Study officials:
name: GOKHAN GOKMEN, Specialist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02995122: Sun Protection Factor Assay (339/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-12-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT01949922: Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter
Official title: Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter - a Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fecal Incontinence
Anal Incontinence
Keywords: regenerative medicine
fecal incontinence
muscle fiber injection
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim:

To investigate efficacy and safety in a new treatment with injection of autologous muscle fibers into the anal sphincter in patients with fecal incontinence.

Method:

Patients with fecal incontinence after obstetric anal sphincter rupture will be included. After inclusion, they will be offered 3 months of pelvic floor muscle training. If the patients after completion of pelvic floor muscle training still suffer from fecal incontinence, the patients will be offered treatment with autologous muscle fiber injection into the anal sphincter. The patients will be followed one year after the injection. The autologous muscle fibers are harvested at the patients leg muscle, cut into small pieces and injected into the anal sphincter. A small part of the fibers are used for analysing number of muscle stem cells and thereby the regenerative potential of the sample.

The study is a pilot study.


Eligibility criteria: Inclusion Criteria:

* fecal incontinence
* Wexner score \>= 9 or affected quality of life.
* Understanding and speaking danish
* Informed consent

Exclusion Criteria:

* Ongoing pregnancy
* Delivery in the last 12 months
* colostomy
* chronic inflammatory bowel disease (mb. crohn, colitis ulcerosa)
* improvement after pelvic floor muscle training in an extent that makes autologous muscle fiber injection unnecessary.

Primary outcomes:
measure: Efficacy of the treatment using fecal incontinence score: Wexner score.
timeFrame: 1 year
Secondary outcomes:
measure: Safety
timeFrame: 1 year
Other outcomes:
measure: Improvement of life quality
timeFrame: 1 year
measure: Improvement of anal sphincter functioning assessed by anal reflectometry
timeFrame: 1 year.
measure: Improvement of fecal incontinence after pelvic floor muscle training.
timeFrame: 3 months
measure: Improvement of the anal sphincter by 3D ultrasound.
timeFrame: 1 year
measure: Correlation between the tissue samples regenerative potential and effect of treatment.
timeFrame: 1 year
Locations:
city: Copenhagen
country: Denmark
facility: Department of Obstetrics and Gynaecology, Herlev University Hospital
state: Herlev
Study officials:
References:
Clinical trial NCT01325922: 50/50% Tilt and Tuned Defibrillation Waveform
Official title: 50/50% Tilt and Tune Defibrillation Waveforms Utilizing High Voltage Lead Integrity Check Impedance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DFT Testing
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-03-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Study Description The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform utilizing High Voltage Lead Integrity Check (HVLIC) impedance.

Hypothesis The Tuned waveform reduces defibrillation thresholds (DFTs) when compared to the 50/50% tilt waveform.

Study Methods

* This is an acute, paired-sample, randomized (waveform testing sequence) study
* Patients are implanted with an Food and Drug Administration (FDA) approved St. Jude Medical (SJM) EpicTM+ DR/VR Implantable Cardioverter Defibrillator (or any other standard output ICD after Epic+) and defibrillation lead system.
* All study testing is completed at implant.
* Patients are randomized to begin DFT testing with either the 50/50% tilt or Tuned waveform.
* The HVLIC feature is used to measure the high voltage lead impedance and to program the Tuned and 50/50% tilt waveform pulse widths.
* The DFT is determined by an optimized binary search method that is designed to reduce the overall number of VF inductions to an average of 5.13 while maintaining very high resolution and accuracy.
* Total # of centers - 15 centers
* Sample size - 60 patients


Eligibility criteria: Inclusion Criteria:

* Patient is a candidate for ICD implantation.
* Patient is able to tolerate DFT testing.

Exclusion Criteria:

* Patient has a mechanical valve in the tricuspid position.
* Patient is pregnant.
* Patient is less than 18 years old.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05661422: Analysis of Lung Sounds Collected by RESP Biosensor to Support Decision Making in Monitored Hospitalized Pediatric Patients
Official title: Spectrographic and Acoustic Analysis of Lung Sounds Collected by RESP™ Biosensor to Support of Cardiorespiratory Therapeutic Decision Making in Monitored Hospitalized Pediatric Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pediatric Respiratory Diseases
Asthma
RSV Infection
COVID-19
Lead sponsor: Strados Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-22
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric subjects who are admitted to the hospital with respiratory disease, including exacerbation of chronic respiratory disease and infection of RSV or COVID-19

Brief summary: This observational clinical trial is designed to confirm whether RESP™ Biosensor could be deployed to support clinical decision making in challenging pediatric cases, minimize clinician-to-clinician variability in lung sound interpretation, obviate the need to disrupt change of shift or chart rounds with physicians, and create a durable archive of the patient's lung sounds for longitudinal comparison within or across hospitalizations.


Eligibility criteria: Inclusion Criteria:

1. Children between the ages of 4 and 17 with documented physician-diagnosed respiratory disease including infection such as RSV or COVID
2. Hospitalization projected for at least 24 hours after device placement
3. Patient and parent/guardian able and willing to provide informed consent/assent.

Exclusion Criteria:

1. Patient and parent/guardian unable or unwilling to provide informed consent
2. Patient expected to undergo prolonged invasive radiology procedure(s)
3. Plan for discharge within 24 hours
4. Patient expected to undergo major thoracic surgery
5. History of adverse reaction or allergy to TegaDerm ® or similar product

Primary outcomes:
measure: Qualification and verification of lung sounds in pediatric population using RESP Biosensor
timeFrame: Periodic recording over 24 hours for inpatient stay
Secondary outcomes:
measure: Acceptability and utilization of RESP Biosensor in clinicians, healthcare staff and patient families
timeFrame: Periodic recording over 24 hours for inpatient stay
measure: Limitations such as age in pediatric patients
timeFrame: Periodic recording over 24 hours for inpatient stay
Other outcomes:
Locations:
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
Study officials:
References:
Clinical trial NCT03142022: Sleep-disordered Breathing After Solid Organ Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Transplantation
Sleep-disordered Breathing
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 1 year after lung transplantation are systematically evaluated by polysomnography.

Brief summary: Sleep-disordered breathing (SDB) describes a group of disorders in which partial or complete cessation of breathing occurs many times throughout the night, resulting in daytime sleepiness or fatigue that interferes with a person's ability to function and reduces quality of life. Transplantation has become an important treatment modality for end-stage organ failure. Transplant recipients are now living longer and, hence, develop chronic adverse medical conditions. Furthermore, transplantation is associated with weight gain. Despite the high prevalence of poor sleep and cardiovascular conditions among transplant patients, SDB is not well studied in these patients.

Detailed description: The primary research objective is to evaluate the prevalence, incidence and type (central or obstructive) of SDB in patients after lung transplantation.

Secondary research objectives are the evaluation of correlations between severity of SDB and clinical findings (weight, medical therapy, heart function, lung function, renal function, graft failure, ...). Furthermore, the investigators will evaluate the relationship between SDB and cardiovascular morbidity.

Eligibility criteria: Inclusion Criteria:

* Patients 1 year after lung transplantation

Exclusion Criteria:

* Refusal of PSG
* Medical contra-indication to perform PSG

Primary outcomes:
measure: Number of participants with SDB and type (central or obstructive) of SDB
timeFrame: 1 year after lung transplantation
Secondary outcomes:
measure: Echocardiography
timeFrame: 1 year after lung transplantation
measure: Lung function measurement
timeFrame: 1 year after lung transplantation
measure: Blood analysis
timeFrame: 1 year after lung transplantation
measure: 24h blood pressure
timeFrame: 1 year after lung transplantation
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Dries Testelmans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06834022: Comparison of Neuromodulatory Treatment of Migraine Headache with Acupuncture and Transcranial Direct Current Stimulation
Official title: Comparison of Neuromodulatory Treatment of Migraine Headache with Acupuncture and Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Migraine
Keywords: tDCS
acupuncture
CGRP
inflammatory biomarkers
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 120
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 goal of this clinical trial is to compare effects of the treatment with acupuncture and transcranial direct current stimulation (tDCS) in patients with migraine headache. The main questions it aims to answer are:

* is tDCS more effective than acupuncture/placebo?
* is there any difference in venous blood inflammatory parameters (CGRP (calcitonin gene related peptide), IL (interleukine) -6, IL-8. IL-10, SAA (serum amyloid A) and ESR (erythrocyte sedimentation rate) before/after treatment?
* could these inflammatory parameters function as biomarkers of disease and/or indicators of treatment's efficacy?

Participants will regularly fill out questionnaires (migraine diary) and their venous blood before/after treatment will be taken for analysis.

Researchers will compare the effects of sham and verus treatment of both methods before and after treatment.


Eligibility criteria: Inclusion Criteria:

* 4 migraine days per month
* no acupuncture in the past
* understanding of study design and ability to give informed consent

Exclusion Criteria:

* severe psychiatric disorders
* pacemaker
* status post brain surgery with open skull
* brain stimulators
* metal implants
* biologic drugs
* pregnancy

Primary outcomes:
measure: Number of days with migraine headache per month
timeFrame: 4 months
Secondary outcomes:
measure: Severity of migraine headache
timeFrame: 4 months
measure: Change of inflammatory parameters
timeFrame: 4 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Hospital dr. Petra Držaja
Study officials:
affiliation: University of Ljubljana
name: Manja Mlakar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01032122: Rituximab in Metastatic Melanoma
Official title: Efficacy and Safety of Rituximab, an Anti-CD20 (Cluster of Differentiation Antigen 20) Therapeutic Agent, in Metastatic Melanoma: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metastatic Melanoma
Keywords: melanoma
rituximab
metastatic
stage IIIc/IV
stem cell
overall survival
disease free interval
anti-CD20 therapy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 9
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 determine whether rituximab as an adjuvant therapy in clinical stage IIIc / IV (no evidence of disease, AJCC (American Joint Committee on Cancer) 2002) melanoma patients is safe and prolongs overall survival and disease-free interval.


Eligibility criteria: Inclusion Criteria:

* Histologically verified non-ocular melanoma stage IIIc/IV, no evidence of disease

Exclusion Criteria:

* ECOG (Eastern Cooperative Oncology Group) performance status \> 2
* Ocular melanoma
* Immunodeficiency syndromes or hypogammaglobulinaemia
* Active autoimmune diseases
* Treatment with immunosuppressive agents other than steroids
* Depressed bone marrow function (Leukopenia \<3000, platelet count \<100.000)
* Cardiac insufficiency NYHA (New York Heart Association) IV
* active Hepatitis B,C, or HIV infection
* Pregnancy or lactation
* Interstitial pulmonary disease
* Former treatment with anti-CD20 antibody

Primary outcomes:
measure: disease-free interval
timeFrame: 42 months
Secondary outcomes:
measure: overall survival
timeFrame: 42 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: General Hospital Vienna, Dep. of Dermatology, Division of Immunology and Infectious Diseases
Study officials:
affiliation: Med Univ Vienna
name: Stephan Wagner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Univ Vienna
name: Alice Pinc, MD
role: PRINCIPAL_INVESTIGATOR
References: