louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01184430: Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery
Official title: Monocentric Pilot Study of Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Wound Infection
Postoperative Outcome
Keywords: advanced hemodynamic monitoring
goal-directed therapy
cardiac surgery
hemodynamic monitoring
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 40
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: Cardiac surgery patients have a high risk to suffer from postoperative infections. Some studies have shown, that humoral and cellular factors are associated with perioperative immunodysfunction and can increase the risk of postoperative infections. Monocytes in the blood and, especially alveolar macrophages are important for an adequate host defence. In studies the investigators have shown that hemodynamic parameters have a significant influence on the probability to develop postoperative infections. The aim of the study is to investigate, whether cardiac surgery patients have an altered immune function after surgery that is predictive for the latter development of subsequent infections and whether they benefit from a goal-directed volume and hemodynamic therapy.


Eligibility criteria: Inclusion Criteria:

* elective cardiac surgery patient undergoing cardiopulmonary bypass
* signed informed consent

Exclusion Criteria:

* pregnant or breast feeding women
* Age \<18 years
* pulmonary disease with an oxygenation index \<300mmHg
* liver disease (\>Child B)
* HIV-Infection
* Therapy with corticosteroids
* Condition after transplantation
* preexisting infection before operation

Primary outcomes:
measure: HLA-DR Expression on monocytes after surgery
timeFrame: 24 hours
Secondary outcomes:
measure: ICU stay
timeFrame: 24 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Study officials:
affiliation: Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
name: Michael Sander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
name: Claudia Spies, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03468530: Therapeutic Effects of Endoscopic Ablation of Hunner Lesions in Interstitial Cystitis/ Bladder Pain Syndrome Patients
Official title: Therapeutic Effects of Endoscopic Ablation of Hunner Lesions in Interstitial Cystitis/ Bladder Pain Syndrome Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Cystitis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 500
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: tertiary hospital

Brief summary: efficacy of endoscopic ablation of Hunner lesions in patients with IC/BPS and the characteristics of HLs based on a long-term follow-up


Eligibility criteria: Inclusion Criteria:

1. Male and female aged 18 yrs or greater
2. Patients diagnosed with BPS(Bladder Pain Syndrome)
3. Symptom persisted more than 6 months
4. Pain VAS ≥4
5. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) scores 12 or greater with pain and nocturia domain scores \> 2.
6. Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) \>13
7. No history of cystoscopy within 2yrs.

Exclusion Criteria:

1. History of augmentation cystoplasty or previous transurethral coagulation/resection due to BPS
2. Child-bearing potential, pregnant or nursing women.
3. Mean voided volume lesser than 40ml or over than 400ml.
4. Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
5. Urinary tract infection during run-in periods.
6. Genitourinary tuberculosis or bladder,urethral and prostate cancer
7. Recurrent urinary tract infection
8. History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
9. Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.-

Primary outcomes:
measure: change in recurrence-free survival time after ablation treatment
timeFrame: Every three months for one year
Secondary outcomes:
measure: changes in mean number of daytime frequency episodes
timeFrame: Every three months for one year
measure: changes in mean number of nocturia episodes
timeFrame: Every three months for one year
measure: changes in mean number of urgency episodes
timeFrame: Every three months for one year
measure: Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
timeFrame: Every three months for one year
measure: Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score
timeFrame: every 3months for one year
measure: Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
timeFrame: Every three months for one year
measure: Change score of Brief Pain Inventory-short form (BPI-sf)
timeFrame: Every three months for one year
measure: Occurrence of adverse event
timeFrame: Every three months for one year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
References:
Clinical trial NCT00634530: Impact of a Nutritional Intervention Program for Weight Control During Pregnancy
Official title: Impact of a Nutritional Intervention Program for Weight Control During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Complications
Weight Gain
Keywords: Pregnancy
Prenatal Care
Weight
Nutritional Status
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 318
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a randomized clinical trial for evaluate the impact of a nutritional intervention in the weight control of pregnant women according to the nutritional status, and consequently, the reduction of pregnancy complications.

The sample of this study will be composed by 318 pregnant women in the pre-natal care unit of the Health Center in Viamão city / Rio Grande do Sul, including women between the 10th and 25th weeks of gestation, aged up to 35 years old. The eligible pregnant women will be invited by the fieldworks to participated in the trial after be informed about the overall aims of the study. These women willing to participate will be randomly allocated to either the intervention or control group. The intervention group received specific guidelines about feeding practices appropriate to each nutritional status.

Data on pregnant women will be collected through a questionnaire in both groups, and to assess the food intake, three 24-hour food recall will be applied in the interventional group and two recall in the control group, in initial and final gestational period. In all appointments pregnant women of the two groups will be weight and classified according to Body Mass Index of pre-gestational (BMI).

The dietary advices will be elaborated by the author of the project and nutrition graduation students of Federal University of Health Science of Porto Alegre.


Eligibility criteria: Inclusion Criteria:

* Women between the 10th and 25th weeks of gestation
* To concern in the prenatal care group in basic health unit

Exclusion Criteria:

* Pregnant with diseases that require specific treatment at the onset enrollment (HIV, diabetes, hypertension and anemia)
* Women 36 years or older.

Primary outcomes:
measure: Adequated weight gain during pregnancy.
timeFrame: one year
Secondary outcomes:
measure: Prematurity, low birth weight and pregnancy complications.
timeFrame: one year
Other outcomes:
Locations:
city: Viamão
country: Brazil
facility: Health Center
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Health Sciences of Porto Alegre
name: Márcia R Vitolo, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05821530: HFIT Versus TENS Study for Chronic Low Back and Knee Pain
Official title: A Randomized Controlled Clinical Trial Evaluating the Effectiveness of High-frequency Impulse Therapy (HFIT) Versus Transcutaneous Electronic Nerve Stimulator (TENS) for Treatment of Chronic Low Back and Knee Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Knee Pain Chronic
Back Pain, Low
Keywords: musculoskeletal
chronic
pain
knee pain
back pain
Lead sponsor: Hinge Health, Inc
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A high-frequency impulse therapy (HFIT) device (Enso, San Francisco, CA) is a portable device for the treatment of musculoskeletal pain. This three-arm randomized controlled trial study compares a HFIT group to a standard transcutaneous electrical nerve stimulator (TENS) group and a control group.


Eligibility criteria: Inclusion Criteria:

* Age 18 or over and under age 65
* Baseline pain is 40 or more out of 100 on a NPRS
* Member of digital MSK program's chronic back or knee pain program, after January 1, 2023
* Member engaged in the most recent 3 weeks
* Experiencing chronic pain for at least 3 months
* Subject able to understand and provide informed consent
* Has an email account

Exclusion Criteria:

* Diagnosis of cancer/malignant tumors in the last 5 years
* Back or knee surgery in the last 6 months
* Has a cardiac pacemaker, implanted defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other implanted electronic device
* Patients with history of opioid, alcohol, or drug abuse in the last 1 year
* Cognitive, behavioral, neurologic, or psychiatric disorder (e.g., dementia, Parkinson's, schizophrenia, stroke) that may interfere with the study or prevent the subject from complying with the requirements of the protocol
* Pregnant or plan on becoming pregnant in the next year
* Have epilepsy
* Have cardiovascular disease
* Current pain (in the past 24 hours) is less than 40 out of 100 on a NPRS

Primary outcomes:
measure: Pain MCID
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Function MCID (Back)
timeFrame: Baseline and Week 4
measure: Function MCID (Knee)
timeFrame: Baseline and Week 4
measure: Anxiety
timeFrame: Baseline and Week 4
measure: Depression
timeFrame: Baseline and Week 4
measure: Opioid use
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Hinge Health, Inc
state: California
Study officials:
References:
Clinical trial NCT01038830: QuantiFERON Change During Anti-tuberculosis Medication
Official title: The Change in Level of Interferon-gamma Assay in Active Tuberculosis Patients During Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Interferon-gamma Release Assay
Lead sponsor: Armed Forces Capital Hospital, Republic of Korea
Sponsor class: OTHER_GOV
First posted: 2009-12-24
Enrollment: 50
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: Young healthy subjects in Korean military

Brief summary: The aim of this study is to evaluate the change of QuantiFERON-TB gold in tube assay (QFT) during the treatment of active tuberculosis.

Detailed description: Patients with active pulmonary tuberculosis are enrolled and, QFTs are performed for each subjects before treatment and 1, 3, 6 months after treatment. Investigators check the level of interferon-gamma, and reversion and conversion of this test.

Eligibility criteria: Inclusion Criteria:

* All subjects with active tuberculosis

Exclusion Criteria:

* Subjects who cannot complete study
* Subjects who have taken anti-tuberculosis medication for more than a month before visit of our hospital

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Armed Forces Capital Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT06255730: The Effect of Stellate Ganglion Block on Insomnia Patients
Official title: The Effect of Stellate Ganglion Block on Insomnia Patients: a Pre - and Post Control Experiments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 50
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: A prospective study was conducted on Insomnia Patients. All the patients were provided with Stellate Ganglion Block. The quality of sleep was evaluated to see if Stellate Ganglion Block can improve Insomnia.

Detailed description: Insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or experiencing non-restorative sleep, despite having adequate opportunity for sleep. It is a common condition that can significantly impact an individual's quality of life and overall well-being.A prospective study was conducted on Insomnia Patients. All the patients were provided with Stellate Ganglion Block. The quality of sleep was evaluated to see if Stellate Ganglion Block can improve Insomnia.

Eligibility criteria: Inclusion Criteria:

* Insomnia patients with the ages over 18.
* Meeting the diagnostic criteria for chronic insomnia as per the International Classification of Sleep Disorders (ICSD) or the Diagnostic and Statistical Manual of Mental Disorders (DSM).
* Experiencing insomnia symptoms persistently for at least three months.
* Not currently using or ceased using medication for insomnia for at least four weeks.
* Willing to undergo Stellate Ganglion Block treatment and participate in the study.

Exclusion Criteria:

* Patients with severe cardiovascular disease, pulmonary disease, or other serious physical health issues.
* Pregnant or lactating women.
* Patients with mental disorders (such as major depression, anxiety disorders, schizophrenia, etc.) or cognitive impairments.
* Patients with known allergies or contraindications to Stellate Ganglion Block treatment.
* Patients currently participating in other clinical trials or receiving experimental treatments.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: day 1 and day 10
Secondary outcomes:
measure: Anxiety
timeFrame: day 1 and day 10
measure: Sleep Impairment Index
timeFrame: day 1 and day 10
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Center Rehabilitation Hospital
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_CHAIR
References:
Clinical trial NCT05582330: Turkish Version of Telephone Based ABILOCO-Stroke
Official title: Turkish Cultural Adaptation, Validation and Reliability Study of Telephone Based ABILOCO-Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cultural Adaptation
Stroke
Reliability
Validity
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 130
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: NON_PROBABILITY_SAMPLE
Study population: Stroke survivors

Brief summary: The aims of this study were to perform cultural adaptation of the telephone based ABILOCO-stroke instrument and provide information regarding the factor structure, reliability and validity of the instrument in Turkish speaking patients with stroke.


Eligibility criteria: Inclusion Criteria:

* hemiparetic individuals who were ≥ 18 years of age
* were at least 4 weeks after the onset of the stroke
* able to walk with or without assistive devices.

Exclusion Criteria:

* cognitive impairments
* aphasia
* any other non-stroke-related conditions.

Primary outcomes:
measure: Telephone Based ABILOCO-Stroke
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03255330: The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma
Official title: The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Chronic Pain Due to Trauma
Spinal Cord Injuries
Lead sponsor: Masaryk University
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 0
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: Study of the effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma


Eligibility criteria: Inclusion Criteria:

1. Men and women, age 18 - 65 years
2. Signed written informed consent
3. Patients after complete/non-complete spinal lesion, after surgery
4. Patients with spinal cord trauma caused mechanically demanding (due a injury of a bone fragment, a disk, a translation spinal canal)
5. Patient willing and able to comply with the study protocol
6. Male and females with a highly effective method of birth control plus an additional barrier method

Exclusion Criteria:

1. Patients with spinal cord lesion ischemic etiology
2. Pregnant women, nursing or childbearing age with a positive pregnancy test input
3. Patients unable or unwilling to comply with the study protocol
4. Acute pancreatitis in 1 year from the start of the study
5. Chronic pancreatitis in the case history
6. Active or uncontrolled infectious diseases
7. Hypersensitivity to any component of the investigational product
8. Active autoimmune disease
9. Serious neurological disease with the incidence chronic neuropathic pain

Primary outcomes:
measure: Assessment the analgesic effect of gabapentin
timeFrame: in 3 months after initiation of the gabapentin treatment
Secondary outcomes:
measure: The decrease of the incidence of chronic neuropathic pain
timeFrame: in 6., 9. and 12. months after initiation of the gabapentin treatment
measure: The number of painful episodes
timeFrame: in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
measure: The decrease of the consumption of rescue medication
timeFrame: in 3., 6., 9. and 12. months after initiation of the gabapentin treatment
measure: Absolute and percentage change in average pain
timeFrame: in 3., 6., 9. and 12. months
measure: Quality of life
timeFrame: in week 1, 3., 6., 9. and 12. months after initiation of the gabapentin treatment
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Fakultní nemocnice Brno
Study officials:
References:
Clinical trial NCT04936425: Comparison of Stent Suturing Versus OTSC Stentfix
Official title: Comparison of Stent Suturing Versus OTSC Stentfix in Preventing Esophageal Stent Migration in Non-Stricture Esophageal Lesions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Esophageal Stent Fixation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether OTSC stentfix is a feasible, safe, and efficient device that can be used for esophageal stent fixation (to prevent stent migration) in patients with benign, non-stricture esophageal lesions, including leaks, perforation, and fistulae. Currently, self-expandable metal stents (SEMS) have a risk of migration which can lead to adverse events such as bleeding and perforation. There has been clinical experience demonstrating that stent suturing can prevent stent migration. However, stent suturing can significantly increase endoscopic procedural time. The use of OTSC stentfix for stent fixation is promising as it is likely less time-consuming and less technically difficult, with likely a similar rate of fixation and migration. This non-inferiority study aims to investigate how OTSC stentfix functions as compared to stent suturing. If OTSC stentfix is at least comparable to stent suturing, it can reduce endoscopy procedural times, minimize peri-endoscopic risks, and minimize adverse events related to stent migration.


Eligibility criteria: Inclusion Criteria:

* All adults (18+ years)
* Have benign, non-stricture esophageal lesions (i.e. fistulae, perforation, leaks) warranting esophageal stent placement as an inpatient or outpatient
* Ability to consent to stent fixation.

Exclusion Criteria:

* \< 18 years old

Primary outcomes:
measure: Average rate of stent migration
timeFrame: 48 weeks
Secondary outcomes:
measure: Procedural time needed for stent fixation
timeFrame: 120 minutes
measure: Duration of time until stent migration for stents that fail fixation
timeFrame: 48 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Gregory Haber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Lauren Khanna, MD
role: PRINCIPAL_INVESTIGATOR
References: