louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00243971: A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease
Official title: A Phase 3, Randomized, Open-Label, Two-Arm, Parallel-Group, Multicenter, Multinational Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: EARLY-STAGE, IDIOPATHIC PARKINSON'S DISEASE
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-10-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to compare the effect of rotigotine (SPM 962) and ropinirole on the control of early morning motor impairment and sleep disorders in subjects with early-stage PD.

Subjects who meet eligibility criteria will be randomly assigned either to rotigotine transdermal patch or ropinirole tablets. Trial medication will be titrated for rotigotine and ropinirole until an individual optimal dose is achieved. Following a Titration period of up to 4 weeks in the rotigotine arm and 6 weeks in the ropinirole arm, subjects will be maintained on the optimal or maximal dose for 4 weeks. At the end of the Maintenance period, subjects will be given the opportunity to enter a 2-year rotigotine patch extension trial.

The first subject was enrolled in December 2004. The last subject was enrolled in June 2005. Last subject out is expected for October 2005. The trial is still ongoing.


Eligibility criteria: Inclusion Criteria:

* Early-stage, idiopathic Parkinson's disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Monheim
country: Germany
facility: Schwarz
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02074371: Postoperative Respiratory Depression After Cardiac Surgery
Official title: Perioperative Parameters to Predict Postoperative Respiratory Depression After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: coronary artery bypass surgery
cardiopulmonary bypass
ICU
postoperative respiratory depression
Lead sponsor: Universidade Camilo Castelo Branco
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease submitted to elective CABG with CPB.

Brief summary: Coronary artery bypass graft surgery (CABG) is associated with postoperative respiratory depression. In this study we aimed at investigating perioperative parameters that could predict the nadir of postoperative respiratory function impairment.

Detailed description: Coronary artery bypass graft (CABG) surgery is a principal revascularization option for ischemic heart disease and the principal modality for invasive treatment of coronary artery disease. Postoperative pulmonary complications are the most frequent and significant contributor to length of hospitalization, morbidity and mortality. The objective of this study is to search for perioperative parameters that could predict the degree of impairment of respiratory function after CABG with cardiopulmonary bypass (CPB).

Eligibility criteria: Inclusion Criteria:

* patients of both sexes older than 18 years submitted to CABG with CPB, presence of coronary disease confirmed by coronary angiography, use of the left internal thoracic artery and/or saphena, patients who remained in spontaneous ventilation on the first postoperative day, absence of chronic or acute pulmonary disease, and giving written informed consent to participate in the study.

Exclusion Criteria:

* intraoperative change of the surgical technique, surgical complications or complications occurring in the ICU, emergency reoperation, renal failure, failure to agree to continue in the study, presence of other types of heart disease, and presence of pulmonary diseases.

Primary outcomes:
measure: Postoperative Respiratory Depression After Cardiac Surgery
timeFrame: 9 days
Secondary outcomes:
measure: Intraoperative parameters after coronary artery bypass graft surgery (CABG)
timeFrame: 1 day
measure: Perioperative parameters after coronary artery bypass graft surgery (CABG)
timeFrame: 3 days
Other outcomes:
Locations:
city: Teresina
country: Brazil
facility: Hospital Sao Marcos
state: Piauí
Study officials:
affiliation: Camilo Castelo Branco University (UNICASTELO)
name: Ovidiu C Baltatu, MD PhD
role: STUDY_CHAIR
References:
citation: Costa AS, Costa PH, de Lima CE, Padua LE, Campos LA, Baltatu OC. ICU Blood Pressure Variability May Predict Nadir of Respiratory Depression After Coronary Artery Bypass Surgery. Front Neurosci. 2016 Jan 11;9:506. doi: 10.3389/fnins.2015.00506. eCollection 2015.
Clinical trial NCT00119171: Ispinesib In Combination With Capecitabine In Patients With Solid Tumors
Official title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination With Capecitabine on an Every 21-Day Schedule in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor Cancer
Keywords: Safety
tolerability
dose limiting toxicity
solid tumors
capecitabine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the dose regimen of Ispinesib in combination with capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest period. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.


Eligibility criteria: Inclusion criteria:

* Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.
* ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
* Bone marrow function: - ANC greater than 1500/mm3.
* Platelet count greater than or equal to 100,000/mm3.
* Hemoglobin greater than 9 g/dL.
* Renal function: - Calculated creatinine clearance greater than or equal to 50 mL.min.
* Total bilirubin greater than 1.5 mg/dL.
* AST/ALT less than 2.5 X upper limit of normal.

Exclusion criteria:

* Females who are pregnant or nursing.
* Pre-existing hemolytic anemia.
* Pre-existing peripheral neuropathy greater than or equal grade 2.
* Known deficiency in dihydropyrimidine dehydrogenase (DSD).

Primary outcomes:
measure: Plasma levels for SB-715992 and Capecitabine
timeFrame: will be checked at Day 1 for Cycle 1.
Secondary outcomes:
measure: - Medical history
timeFrame: at screening
measure: - ECOG Performance Status, Physical Exam, vitals, & labs
timeFrame: done at screening, Week 1 (each cycle), & follow-up (f/u)
measure: - Continuous Adverse Event monitoring
timeFrame: throughout the study
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04683471: Pilot Trial of a System for Motor Function Recovery
Official title: Pilot Feasibility Clinical Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Diseases
Lead sponsor: Niche Biomedical, Inc. dba ANEUVO
Sponsor class: INDUSTRY
First posted: 2020-12-24
Enrollment: 12
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a multi-center, prospective, blinded, pilot feasibility study to evaluate improvement in sensory and motor function with sham.


Eligibility criteria: Inclusion Criteria:

* Traumatic chronic spinal cord injury

Exclusion Criteria:

* Active implanted medical device
* Internal metallic objects of unknown or foreign origin
* Implanted anti-spasticity pumps, Botox injections in prior 3 months or other current anti-spasticity regimen
* BMI \> 40.0
* Acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds
* Pregnancy or planned pregnancy
* Unhealed bone fractures, peripheral neuropathies or painful musculoskeletal dysfunction
* Cardiopulmonary disease or ventilator dependency
* Uncontrolled epilepsy or seizures
* Clinically significant depression, psychiatric disorders or ongoing substance abuse

Primary outcomes:
measure: Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
timeFrame: Biweekly through study completion up to 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
Study officials:
References:
Clinical trial NCT05885971: Detection of Eating Disorders in Pregnant Women
Official title: Detection of Eating Disorders in Pregnant Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Disorders
Pregnancy Related
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Eating disorders (ED) are insufficiently detected and belatedly or not treated during pregnancy.

There are many screening questionnaires for eating disorders in the literature, but we note the absence of a specific and validated tool for their screening during pregnancy, which would make it possible to differentiate maternal dietary concerns related to pregnancy from symptoms linked to a proven eating disorder.

The main objective of the study is to evaluate which items of the Sick Control One stone Fat Food (SCOFF-F) and Eating disorders examination questionnaire (EDE-Q) questionnaires could be specific to an ED during pregnancy and not related to the simple state of pregnancy, by comparing the answers of pregnant women, for whom the diagnosis of ED has been made, to those of pregnant women without an ED.


Eligibility criteria: Inclusion Criteria:

* Adult pregnant woman
* Woman with current diagnosed Eating Disorders or without Eating Disorders
* Having a good command of the French language
* Having given their consent for their participation in the research

Exclusion Criteria:

* Underage pregnant woman
* Woman who does not have a good command of the French language.
* Woman with past Eating Disorders

Primary outcomes:
measure: Specific Eating Disorders items in pregnant women
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
References:
Clinical trial NCT05827471: Clinical Study of QSOX1 as a Biomarker for Colon Cancer
Official title: Clinical Application of Sulfhydryl Oxidase QSOX1 as a New Biomarker of Colon Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colon Cancer
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The patients diagnosed with colon cancer for the first time admitted to the First Affiliated Hospital of Shandong First Medical University.

Brief summary: The goal of this observational study is to determine whether the secreted protein QSOX1 can be used as a molecular marker for early rapid diagnosis and accurate treatment of colon cancer.

Detailed description: The project mainly selects the tumor group represented by colon cancer and the corresponding healthy people as the control group, with about 100 cases in each of the two groups. Mainly collect blood and tumor tissue samples of patients, detect the expression of QSOX1 in the above samples, and explore the role in the diagnosis and prognosis evaluation of colon cancer.

Eligibility criteria: Inclusion Criteria:

* Colon cancer was confirmed by colonoscopic pathology.
* No local or systemic treatment was performed before operation.
* Complete clinical data.

Exclusion Criteria:

* Combined with benign diseases of colon, such as ulcerative colitis, colon adenoma and colon polyp.
* Other tumors other than colon cancer.

Primary outcomes:
measure: Detection of RNA for early rapid diagnosis of colon cancer.
timeFrame: 6 months
measure: Detection of protein for early rapid diagnosis of colon cancer.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04151771: Low-load Blood Flow Restriction Training in COPD
Official title: Low-load Blood Flow Restriction Training in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Muscle Weakness
Keywords: blood flow restriction training
pulmonary rehabilitation
COPD
muscle weakness
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peripheral muscle weakness is a predominant problem in patients with COPD and treated using exercise training in pulmonary rehabilitation. Despite pulmonary rehabilitation being an effective intervention, muscle strength impairment is a persisting problem in COPD patients. Patients have problems to tolerate the high training loads, which are necessary to develop strength. Low-load blood flow restriction training (LL-BFRT) might therefore be an option to enhance muscular response of patients with COPD to strength training. Up to now, no studies investigating LL-BFRT in respiratory diseases are available.

The primary outcome of this randomized pilot study is knee extensor muscle strength. Secondary, the study will evaluate if LL-BFRT is well tolerated and feasible in COPD patients attending outpatient pulmonary rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Diagnosed COPD according to GOLD-guidelines
* Assigned to outpatient pulmonary rehabilitation by the treating physician

Exclusion Criteria:

* Physical or intellectual impairment precluding informed consent or protocol adherence
* Non-German speaking (precluding informed consent)
* Acute or recent (within the last 6 weeks) exacerbation of COPD
* Attending a pulmonary rehabilitation program within the last 3 months
* Pregnant patients
* History of thromboembolic event in the lower extremity
* Diagnosis of polyneuropathy
* Resting systolic blood pressure \<100 mmHg

Primary outcomes:
measure: Knee extensor strength
timeFrame: during 12 weeks (24 exercise sessions)
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
Clinical trial NCT00435071: The Effect of Surgical Incision Size on Carpal Tunnel Surgery
Official title: The Effect of Surgical Incision Size on Carpal Tunnel Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2007-02-14
Enrollment: 100
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: This study will investigate the postoperative recovery advantages from having a smaller incision to a larger incision.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing open carpal tunnel release will be included in this study.
* Patients must have clinical evidence of Carpal Tunnel Syndrome
* Patients must have positive EMG results

Patient selection factors include:

1. Ability and willingness to follow instructions
2. Patients who are able and willing to return for follow-up evaluations.
3. Patients of all races and genders.
4. Patients who are able to follow care instructions.

Exclusion Criteria:

* Patients less than 18 years old
* Patients unwillingly or unable to comply with a rehabilitation program for carpal tunnel release who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
* Patients who qualify for inclusion in the study, but refuse consent to participate in the study.

Primary outcomes:
measure: Function questionnaires, pain assessment questionnaires, and clinical measurements will be used to determine the outcome of this study.
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Orthopaedic Institute
state: Tennessee
Study officials:
affiliation: VUMC
name: Julie Daniels
role: STUDY_DIRECTOR
References:
Clinical trial NCT02132871: Preload Dependency by Impedance Cardiography After Cardiac Surgery
Official title: Noninvasive Assessment of Preload Dependency by Passive Leg Raising Test and Impedance Cardiography Compared to Echocardiographic Measurements After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery With Extracorporeal Circulation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 65
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: Patients requiring cardiac surgery

Brief summary: The primary purpose of this study is to investigate wether the measure of stroke volume (SV) variations by impedance cardiography during passive leg raising (PLR) can reliably predict preload dependency after cardiac surgery, in comparison to a reference parameter : velocity time integral (VTI) variation measured by transthoracical echocardiography.


Eligibility criteria: Inclusion Criteria:

* Men or women over 18 years
* Affiliated to a social protection
* Signed written consent
* Informed about the results of the medical visit
* All type of cardiac surgery with extracorporeal circulation performed at University Hospital of Strasbourg
* Sedated and under mechanical ventilation

Exclusion Criteria:

* Cardiac arrhythmia
* Contraindication to PLR maneuver
* Exclusion period due to inclusion in a previous or ongoing study
* Impossibility to provide enlightened information
* Patient deprived of liberty, under judicial protection, trusteeship or guardianship
* Pregnancy, lactation

Primary outcomes:
measure: Area under ROC curve comparing SV variation (impedance cardiography) and VTI variation after PLR
timeFrame: Within the 6 first hours after cardiac surgery
Secondary outcomes:
measure: Variation of central veinous pressure, left auricular pressure and left ventricular filling pressures after PLR (ROC curves, correlation tests)
timeFrame: Within the 6 first hours after cardiac surgery
measure: Respiratory variation of inferior vena cava
timeFrame: Within the 6 first hours after cardiac surgery
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésiologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Nassim HESHMATI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04242771: Mindfulness Meditation for Insomnia
Official title: Neurophysiological Patterns of Mindfulness Meditation for Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a pilot study evaluating the feasibility and acceptability of a non-pharmacological, mind-body intervention to improve sleep quality, including a preliminary evaluation of neurophysiological signals. The study involves 4 weeks of guided mind-body practice at home using a smartphone app during bedtime and pre/post in-lab sleep study visits.


Eligibility criteria: Inclusion Criteria:

* 1. age 20 - 50 years\*
* 2. chronic insomnia (defined by Diagnostic and Statistical Manual Diploma in Social Medicine, DSM-V or International Classification of Sleep Disorders - Third Edition, ICSD-3) with sleep latency \>20 minutes
* 3. speak and understand English
* 4. have a smart phone for mobile app installation

Exclusion Criteria:

* 1. sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, sleep deprivation, jet lag, etc)
* 2. shift worker or routine night shifts
* 3. women with pregnancy or breast feeding
* 4. history of head trauma or surgery
* 5. regular (defined as twice a week or more) practice of mind-body interventions
* 6. neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.)
* 7. current use of neurologic, psychiatric, or cardiovascular medications that have expected neuropsychiatric or cardiovascular effects (i.e., beta-blockers, hypnotics, antidepressants).

Primary outcomes:
measure: Feasibility (i.e., subject retention at initial follow-up assessment)
timeFrame: At one month follow up visit
Secondary outcomes:
measure: Acceptability
timeFrame: At completion of the 4 week program
Other outcomes:
measure: Insomnia Severity Index
timeFrame: At baseline and at the end of 4-week program
measure: Polysomnogram-derived sleep onset latency
timeFrame: At baseline and at the end of 4-week program
measure: Polysomnogram-derived sleep efficiency
timeFrame: At baseline and at the end of 4-week program
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: