louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03168048: Oncologic Therapy Support Via Means of a Dedicated Mobile App
Official title: Oncologic Therapy Support Via Means of a Dedicated Mobile App - a Prospective Feasibility Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Neoplasm
Pelvic Neoplasm
Radiotherapy; Complications
Oncologic Disorders
Breast Cancer
Satisfaction
Quality of Life
Keywords: mobile application
radiotherapy
patient-care
mhealth
follow-up
patient satisfaction
quality of life
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-center prospective exploratory study
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The present single-center prospective exploratory study, conducted at Heidelberg University Hospital, assesses the feasibility of introducing a concept for additional patient care based on a mobile application for patients undergoing radiotherapy. Patients presenting themselves for the irradiation of thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related Quality of Life (QoL) and symptoms and their need to personally consult a physician on a treatment-daily basis by means of a mobile application. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and diagnosis-related QoL is assessed by PSQ-18 and EORTC questionnaires at the end of radiotherapy and at the first follow-up.


Eligibility criteria: Inclusion Criteria:

* Indication for radiotherapy with potentially curative intent of a primarily thoracic or pelvic target
* Karnofsky performance score (KPS) ≥ 70%,
* Ability to initiate the therapy as an outpatient
* ≥ 18 years of age

Exclusion Criteria:

* Inability to give informed consent

Primary outcomes:
measure: Feasibility judged by number of questions answered by each patient on each treatment day
timeFrame: 12-14 weeks
Secondary outcomes:
measure: Treatment-related patient satisfaction
timeFrame: 12-14 weeks
measure: Diagnosis-related Quality of Life
timeFrame: 12-14 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Dept of Radiation Oncology, University of Heidelberg, Germany
Study officials:
affiliation: Heidelberg Institute of Radiation Oncology (HIRO)
name: Nils Nicolay, PD Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: El Shafie RA, Bougatf N, Sprave T, Weber D, Oetzel D, Machmer T, Huber PE, Debus J, Nicolay NH. Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial. JMIR Res Protoc. 2018 Mar 6;7(3):e70. doi: 10.2196/resprot.8915.
Clinical trial NCT00921648: Clinical Findings in General Paresis
Official title: Xijing HOSPITAL, Fourth Military Medical University, China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Paresis
Keywords: EEG
general paresis
MRI
neurosyphilis
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2009-06-16
Enrollment: 6
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 6 cases

Brief summary: This is a study of the clinical and neuroimaging of general paresis. The investigators studied six patients with general paresis.

Detailed description: Inclusion Criteria:

* Mental disorders
* positive TPHA in CSF and sera
* HIV-negative serology by ELISA

Exclusion Criteria:

* Negative TPHA in CSF and sera
* No image data

Eligibility criteria: Inclusion Criteria:

* EEG MR

Exclusion Criteria:

* Serological test

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: department of neurology ,xijing hospital
name: yuangui huang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04388748: Stress Management and Resiliency Training for Depression vs Treatment as Usual in the Treatment of Major Depression
Official title: Randomized Controlled Trial of Stress Management and Resiliency Training for Depression (SMART-D) vs Treatment as Usual in the Treatment of Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 27
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Researchers are trying to find out if a Stress Management and Resiliency Training (SMART-D) therapy will help with major depression treatment.


Eligibility criteria: Inclusion Criteria:

* Participants will be enrolled for this study from patients attending the Mayo Clinic Depression Center, Mayo Clinic Family Medicine clinics, Behavioral Health and Primary Care Clinic at Mayo Clinic Health System, Austin, MN, with a diagnosis of major depression, in partial or near remission with PHQ-9 scores ≤14
* Participants will be required to be between 25 and 80 years old
* Able to speak English
* Able to provide written informed consent to participate in the study
* Participants must have DSM-V diagnostic confirmation of major depressive disorder (MDD) (American Psychiatric Association 2013).
* Participants will continue taking any prescribed medications from their clinical treatment team.
* Participants with co-morbid secondary diagnoses of persistent depressive disorder and generalized anxiety disorders will be included in the study.
* Participants must consent to audio recording of random group sessions which will be disclosed at the final study session.

Exclusion Criteria:

* Participants with bipolar disorder, active psychosis, active suicidal ideations, and active substance abuse meeting criteria for substance use disorders except nicotine, obsessive compulsive disorder, active panic disorder with agoraphobia or other phobic disorder, active posttraumatic stress disorder, active severe personality disorders will be excluded.
* Pregnant women - because of time duration of the study.

Primary outcomes:
measure: Change in patient health questionnaire depression assessment
timeFrame: Baseline, week 1, week 8, 3 months, 6 months
measure: Change in severity of depression
timeFrame: Baseline, week 1, week 8, 3 months, 6 months
Secondary outcomes:
measure: Change in measures of resilience
timeFrame: 1 week, 8 week, 3 month, 6 month
measure: Changed in perceived stress scale
timeFrame: 1 week, 8 week, 3 month, 6 month
Other outcomes:
Locations:
city: Albert Lea
country: United States
facility: Mayo Clinic Health System in Albert Lea
state: Minnesota
city: Austin
country: United States
facility: Mayo Clinic Health System in Austin
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ashok Seshadri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04765748: Cytokine Filter Usage During Open Thoracoabdominal Aortic Aneurysm Repair- a Single-center Randomized Prospective Trial
Official title: Cytokine Filter Usage During Open Thoracoabdominal Aortic Aneurysm Repair- a Single-center Randomized Prospective Trial- Cytosorb and Its Imapct on Open TAAA Repair Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Inflammatory Response
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated by open TAAA repair

Brief summary: Prospecrtive study including 20-30 randomized patients treated by open repair because of an TAAA larger than 55 mm During the surgery, a heart lung machine is applied for distal perfusion during aortic cross clamping to enable distal organ perfusion.

Regardless an intensive inflammatory reaction is a well known effect after reperfusion, leading to a uncontrolled inflammation during th first days after surgery. This may be associated to bad outcome and decreased survival rates. By the application of a intraoperative cytokine and DAMP filter this negative ffect could be reduced, resulting in a better outcome after surgery.

Detailed description: Prospecrtive study including 20-30 randomized patients treated by open repair because of an TAAA larger than 55 mm During the surgery, a heart lung machine is applied for distal perfusion during aortic cross clamping to enable distal organ perfusion.

Regardless an intensive inflammatory reaction is a well known effect after reperfusion, leading to a uncontrolled inflammation during th first days after surgery. This may be associated to bad outcome and decreased survival rates. By the application of a intraoperative cytokine and DAMP filter this negative ffect could be reduced, resulting in a better outcome after surgery.

Eligibility criteria: Inclusion Criteria:

Suffering from a TAAA larger than 55mm

Exclusion Criteria:

immunosupprive therapy pregnancy

-

Primary outcomes:
measure: Amount of perioperative catecholamine usage in mg/dl for the first seven days after surgery
timeFrame: 7 days perioperatively -10 day postoperatively
measure: Amount of transfusion required during and after the surgery, assessed in transfusion more or less than 5 blood bags
timeFrame: 7 days perioperatively 5-10 day postoperatively
Secondary outcomes:
measure: Acute kidney injury, measured using serum creatinine in mg/dl
timeFrame: 7 days perioperatively, -10 day postoperatively
measure: Patients survival for the first 12 months after surgery
timeFrame: 12 months 10-14 months postopertaibely
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Alexander Gombert
state: NRW
Study officials:
References:
Clinical trial NCT00938548: Perioperative Administration of Pregabalin for Pain After Mastectomy
Official title: Perioperative Administration of Pregabalin for Pain After Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: mastectomy
pain, postoperative
pregabalin
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2009-07-14
Enrollment: 70
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following total mastectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be VNRS at 1 week and 1 month after operation.


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesia physical status class I \& II
2. Age \> 20 and \< 70 years
3. Robot- assisted endoscopic thyroidectomy

Exclusion Criteria:

1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications
2. Body mass index ≥ 40 kg/m2
3. History of seizure disorder
4. Current therapy with pregabalin, gabapentin, or any opioid
5. Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
6. Insulin-dependent diabetes mellitus
7. Renal insufficiency (estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2)

Primary outcomes:
measure: Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours.
timeFrame: 1, 6, 24, 48 hour
measure: Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.
timeFrame: 1, 6, 24, 48 hour
Secondary outcomes:
measure: Pain Scores (VNRS) at 1 Week and 1 Month After Operation
timeFrame: 1 week, 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia
Study officials:
References:
citation: Kim SY, Song JW, Park B, Park S, An YJ, Shim YH. Pregabalin reduces post-operative pain after mastectomy: a double-blind, randomized, placebo-controlled study. Acta Anaesthesiol Scand. 2011 Mar;55(3):290-6. doi: 10.1111/j.1399-6576.2010.02374.x.
Clinical trial NCT02750748: Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers
Official title: Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2016-04-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.


Eligibility criteria: Inclusion Criteria:

* Males and females 18 to 55 years of age, inclusive.
* Provide written informed consent.
* BMI ranging from 18 to 30 kg/m2, inclusive.
* Adequate venous access.
* No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
* Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration. Female subject of childbearing potential must agree to use an acceptable method of birth control throughout the study and for 30 days after the last study drug administration. Oral contraceptives are prohibited.
* Agree not to ingest alcohol, drinks containing xanthine \>500 mg/day (e.g., Coca Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice.
* Participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.

Exclusion Criteria:

* Please contact site for more information

Primary outcomes:
measure: Plasma Concentration (Cmax)
timeFrame: 48 hours
measure: Plasma Concentration (Tmax)
timeFrame: 48 hours
measure: Plasma Concentration (AUC 0-t)
timeFrame: 48 hours
measure: Plasma Concentration (AUC 0-inf)
timeFrame: 48 hours
Secondary outcomes:
measure: Adverse Events
timeFrame: Maximum of 18 days
measure: Vital Signs
timeFrame: 12 days
measure: 12-lead electrocardiogram
timeFrame: 12 days
measure: Nasal Irritation Scoring
timeFrame: 5 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research, Inc.
state: Kansas
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Nora Chiang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02531048: Normative Values Laser Nociceptive Evoked Potentials Depending on the Age
Official title: Normative Values Laser Nociceptive Evoked Potentials Depending on the Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy volunteers
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Different neurological damage may alter the pain conduction systems centrally (spinothalamic pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal stimulation selectively stimulates the pain pathways and generates nociceptive signals conveyed to the cortex. Registering these cortical responses constitute the technical laser nociceptive evoked potentials. If these tests are routinely used, their interpretation must remain cautious especially in the elderly.

Detailed description: Different neurological damage may alter the pain conduction systems centrally (spinothalamic pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal stimulation selectively stimulates the pain pathways and generates nociceptive signals conveyed to the cortex. Registering these cortical responses constitute the technical laser nociceptive evoked potentials. If these tests are routinely used, their interpretation must remain cautious especially in the elderly. Normal values that are available have been obtained in young subjects. However, various studies have shown that the integration of nociceptive messages depended on age. The aim of this study was to establish normal values of nociceptive evoked potentials for each age group of 18 to 75 years.

Eligibility criteria: Inclusion Criteria:

* major

Exclusion Criteria:

* Neurological history
* Neuralgia history (\> 3 months)
* Pathology can cause neuropathy (unbalanced thyroid dysfunction, diabetes, kidney failure, chronic hepatitis, HIV ...)
* Dermatological disorder known type of Lucite or photosensitivity
* Medical treatment analgesic, psychotropic or anti-epileptic underway
* Toxic acquired in the last 72 hours (alcohol, cannabis, other toxic ...)
* Pregnant women
* Incapacitate to stand still
* Participation in another biomedical research in the field of pain in the three months prior to inclusion.

Primary outcomes:
measure: composite outcomes : latencies (ms) and amplitudes (μV) of nociceptive evoked potential
timeFrame: Day 0
Secondary outcomes:
measure: detection threshold (mJ/mm2)
timeFrame: Day 0
measure: nociceptive threshold (mJ/mm2)
timeFrame: day 0
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Chu de Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Christelle Creac'h, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04982848: Korea Post Marketing Surveillance (PMS) Study of Talzenna®
Official title: A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Talzenna(Registered)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Neoplasms
Keywords: gBRCA
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Talzenna® is indicated as monotherapy for the treatment of adult patients with breast cancer susceptibility gene (BRCA) mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or advanced setting.

Brief summary: Talzenna will be approved for the treatment of gBRCA advanced breast cancer in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Talzenna after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Talzenna will be observed.


Eligibility criteria: Inclusion Criteria:

1. Patient scheduled to start treatment with Talzenna® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (local label)
2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

1. Patients with known hypersensitivity to Talzenna®, or to any of the excipients.
2. Breastfeeding
3. Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.

Primary outcomes:
measure: Incidence of adverse events categorized according to physical organ and disease/symptom
timeFrame: From date of randomization until the 28 calendar days following the last administration of a drug under study
Secondary outcomes:
measure: Overal response (Effectiveness outcome) by Response Evaluation Criteria In Solid Tumors (RECIST) critera
timeFrame: through study completion, an expected average of 8 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00262548: C-Reactive Protein (CRP) in Obese Diabetic Women
Official title: Interventions Study for the Control of Diabetes Mellitus Type 2 in Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Obesity
Menopause
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Mexican National Institute of Public Health
First posted: 2005-12-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
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 determine whether treatment with rosuvastatin for 6 months in obese type 2 diabetic women will improve their lipid profiles and thus prevent the progression to cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* Menopausal
* Diagnosed diabetes mellitus type 2
* Obese (body mass index \[BMI\] \> 25 ≤ 30)

Exclusion Criteria:

* Fasting blood glucose ≥ 200 mg/dl
* CRP \< 2 mg/L and \> 10 mg/L

Primary outcomes:
measure: Patients will be receiving rosuvastatin/placebo for 6 months
measure: They will have baseline laboratory parameters taken such as glycemia
measure: HbA1c (glycosylated hemoglobin), low-density lipoprotein cholesterol (LDL-C), computed tomography (CT), high-density lipoprotein cholesterol (HDL-C), C-reactive protein (CRP), and retaken every 3 months
measure: Every month, patients will be evaluated at the clinic
measure: All participants will receive an intervention on diet and physical activity counseling, which will be carefully monitored.
Secondary outcomes:
measure: Other variables will be: proinflammatory cytokines - tumor necrosis factor (TNF)-alpha, interleukin-6 (IL-6), IL-12, Th2/Th3 cytokines -IL-4, IL-10 and transforming growth factor beta (TGF-beta)
Other outcomes:
Locations:
city: Cuernavaca
country: Mexico
facility: Research site
state: Morelos
Study officials:
affiliation: AstraZeneca
name: Astra Zeneca Mexico Medical Director, MD
role: STUDY_DIRECTOR
affiliation: Mexican National Institute of Public Health
name: Simón Barquera Cervera, MD
role: PRINCIPAL_INVESTIGATOR
References: