louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02756598: Stress, Anxiety and Type A Personality and Analgesics
Official title: Stress, Anxiety and Type A Personality and Analgesics. Impact on Induction Time and Consumption of Analgesics During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative; Dysfunction Following Cardiac Surgery
Keywords: sufentanil
propofol
personality/stress test
fast-track
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 60
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients scheduled for elective cardiac surgery are preoperative evaluated using different personality type, stress and anxiety tests.

Patient are randomized to receive the investigators' standard moderate dose sufentanil (bolus 1microgram/kg and propofol 0.03 mg/kg/min) or low dose sufentanil (bolus 0.5 microgram/kg and propofol 0.06 mg/kg/min).

Detailed description: Patients randomized and the type of induction informed to the anaesthetist 30 minutes before surgery.

Patients are monitored before induction of anesthesia. Propofol is started on the randomized infusion rate. Sufentanil bolus are given according to randomization. BIS level is followed. Time to reach BIS \< 50 is monitored. BIS after 30, 60 and 90 minutes are registered. Lowest BIS during surgery are registered. Total amounts of sufentanil and propofol recorded.

Eligibility criteria: Inclusion Criteria:

* All elective cardiac surgery patients

Exclusion Criteria:

* Patients requiring special attention or monitoring during induction
* Patients with expected longer postoperative ventilation time
* Patients allergic to sufentanil and or propofol
* Participation in other projects
* Pregnancy

Primary outcomes:
measure: Association between preoperative personality/stress/anxiety and time (minutes) to reach anaesthetic depth goal by bi-spectral index (BIS)
timeFrame: Up to 30 minutes
measure: Potential of sufentanil regime on fast-track measured by ventilation time and association with eligible discharge from intensive care unit.
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Sufentanil regime and association to haemodynamic parameters (blood pressures, heart rate, cardiac output, oxygenation)
timeFrame: up to 24 hours
measure: Association between preoperative personality/stress/anxiety tests and postoperative care using postoperative quality score
timeFrame: up to 24 hours
measure: Association between preoperative personality/stress/anxiety and total amounts of sufentanil and propofol
timeFrame: Up to 12 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01914198: Revisiting Parental Survey for Screening for Obstructive Sleep Apnea in Patients Undergoing Polysomnography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Keywords: sleep study
NCH
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 948
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are having a sleep study at NCH.

Brief summary: The investigators are proposing a study where the investigators would give a survey to the parents of patients having a sleep study. The survey would contain questions relating to symptoms of sleep apnea and then the investigators would correlate the parent answers to the results of the sleep study.


Eligibility criteria: Inclusion Criteria:

* Any patient coming for sleep study at Nationwide Children's Hospital and parent willing to fill out questionnaire.
* Children ages 3-18 years old regardless of sex or race.

Exclusion Criteria:

* Parental refusal.

Primary outcomes:
measure: Sleep apnea symptoms
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT06443398: Spine of Caregivers of Children with Cerebral Palsy
Official title: Evaluation of the Spine of Primary Caregivers of Children with Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Spine Deformity
Keywords: Primary Caregivers
Pain
Disability
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 164
Sex: ALL
Minimum age (years): 25
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It was conducted with caregivers of children with Cerebral Palsy who were receiving physiotherapy at Kırşehir Training and Research Hospital Physical Therapy and Rehabilitation Center and who met the exclusion-inclusion criteria.

Brief summary: The purpose of this study was to assess pain (rest, activity, and night pain using the Visual Analog Scale), disability (neck using the Neck Disability Index; lumbar using the Oswestry Disability Index), and curvature (cervical, thoracic, and lumbar using the Spinal Mouse) in primary caregivers of children with cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* Primary caregiver between the ages of 25-54
* Has a child diagnosed with Cerebral Palsy between the ages of 0-18
* Does not have inflammatory pain
* Without pain originating from abdominal-pelvic organs
* Volunteer caregivers were included

Exclusion Criteria:

* Having acute fracture and malignancy
* Had a surgical operation (related to spine disorders)
* Having a care burden for more than one disabled individual
* Caregivers with chronic illnesses (such as neurological, psychological disorders) were excluded

Primary outcomes:
measure: Life Quality
timeFrame: 16 week
measure: Disability
timeFrame: 16 week
measure: Disability
timeFrame: 16 week
measure: Spine
timeFrame: 16 week
Secondary outcomes:
measure: Socio-demographic Form
timeFrame: 16 week
measure: Pain Intensity
timeFrame: 16 week
measure: Gross Motor Function Classification
timeFrame: 16 week
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center
Study officials:
References:
Clinical trial NCT00006498: Chronic Life Stress and Incident Asthma in Adult Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-11-17
Sex: FEMALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To prospectively examine the association between a specific chronic life stressor (i.e., intimate violence exposure) and adult asthma in women.

Detailed description: BACKGROUND:

Etiologies of the rising prevalence and morbidity of asthma are not well understood. Knowledge gaps are particularly significant with respect to adult-onset asthma. The role of stress in the expression of asthma is largely unexplored in large-scale, prospective, epidemiologic studies and such investigation has been identified as a priority by a recent NHLBI expert panel.

DESIGN NARRATIVE:

The study prospectively examines the association between a specific chronic life stressor (i.e., intimate violence exposure) and adult asthma in women participating in the Nurses' Health Study II cohort. Emerging epidemiologic data suggest that exposure to intimate violence is a pervasive chronic life stressor associated with adverse impact on womens' psychological and physical health. Traumatic stress such as that related to intimate violence exposure has been associated with neuroendocrine changes known to cause alterations in neuroendocrine and immune functions important to the pathophysiology of inflammatory diseases including asthma. The investigators are testing the hypothesis that women exposed to high-level chronic stress (violence) will be at greater risk for asthma development than women with low-level stress (violence) exposure. The influence of chronic stress on neuroendocrine and immune function as reflected in morning cortisol expression, for the former, and cytokine profiles and IgE production (T-helper cell polarization), for the latter, will also be examined in a nested case control fashion among these women.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Rosalind Wright
References:
Clinical trial NCT01645098: Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
Official title: Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 53
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an interventional study on Duchenne muscular dystrophy patients who will be receiving sedation for a muscle biopsy as part of another study.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing a muscle biopsy for IRB11-00203.

Primary outcomes:
measure: Time to Sedation Score of 3-4
timeFrame: Immediately prior to incision
Secondary outcomes:
measure: Heart Rate Change After Dexmedetomidine Loading Dose
timeFrame: Baseline to immediately post dexmedetomidine infusion.
measure: Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose
timeFrame: Baseline to immediately post dexmedetomidine infusion.
measure: Oxygen Saturation Change After Dexmedetomidine Loading Dose
timeFrame: Baseline to immediately post dexmedetomidine infusion.
measure: EtCO2 Change After Dexmedetomidine Loading Dose
timeFrame: Baseline to immediately post dexmedetomidine infusion.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph D Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03319498: Postpartum Urinary Retention With Essential Oils (PURE)
Official title: Postpartum Urinary Retention With Essential Oils (PURE): A Randomized Control Trial of Essential Oil Vapor to Reduce Urinary Catheterization in Postpartum Women
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Urinary Retention
Lead sponsor: Mount Carmel Health System
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 390
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of peppermint oil to promote voiding and reduce urinary catheterization among postpartum women.


Eligibility criteria: Inclusion Criteria:

* postpartum patients at Mount Carmel East, Mount Carmel West, and Mount Carmel St. Ann's Hospital
* 18 years or older
* able to read and understand English
* unable to spontaneously void within 6 hours after vaginal delivery or within 6 hours after straight catheter or within 6 hours after catheter removal for cesarean delivery.

Exclusion Criteria:

* patients who have an allergy to peppermint oil
* patients who have asthma
* patients who report sensitivity to smells
* patients who have a clinical condition which precludes walking/use of standard toilet

Primary outcomes:
measure: Resolution of Postpartum Urinary Retention
timeFrame: within 10 minutes after administering study intervention
Secondary outcomes:
measure: Time to resolution of urinary retention
timeFrame: Within 6 hours of postpartum urinary retention
measure: Volume of urine voided
timeFrame: Within 6 hours of postpartum urinary retention
measure: Patient Satisfaction Level
timeFrame: Within one hour of study intervention administration
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Mount Carmel Health System
state: Ohio
Study officials:
affiliation: Mount Carmel Health System
name: Robin L Driver, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06327698: Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure
Official title: Efficacy and Safety of Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure: A Single-arm, Open-label, Multicenter Phase II Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Melanoma
Keywords: locally advanced or metastatic melanoma
cadonilimab
anlotinib
First-Line Therapy Failure
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of cadonilimab (AK104) in combination with anlotinib in the treatment of locally advanced or metastatic melanoma.


Eligibility criteria: Inclusion Criteria:

1. Age \>18 years and ≤ 75 years
2. Has a histologically confrmed diagnosis of malignant melanoma
3. Previously received failed first-line treatment for melanoma
4. Patients may have a history of liver metastases, but the metastases should be less than 3
5. Patients with treatment-asymptomatic brain metastases may be included, must be free of disease progression on computed tomography (CT) or magnetic resonance imaging (MRI), stable for at least 3 months, and free of steroid medication for at least 4 weeks
6. Those with at least 1 measurable lesion (RECIST version 1.1)
7. ECOG 0-1
8. Non-lactating patients
9. Good organ function

Exclusion Criteria:

1. Previous (within 5 years) or concurrent other malignant tumors, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer without recurrence \> 3 years after radical resection
2. Has an active or potentially recurrent autoimmune disease
3. History of severe allergic reaction to any monoclonal antibody and/or component of the study drug
4. Known presence of active tuberculosis TB
5. Currently receiving cancer treatment (chemotherapy, radiotherapy, immunotherapy, or biologic therapy)
6. Received a live vaccine within 30 days prior to the first dose, or plans to receive a live vaccine during the study
7. Known history of psychiatric illness, substance abuse, alcoholism, or drug abuse

Primary outcomes:
measure: Response Rate
timeFrame: from the frst drug administration up to two years
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: from the frst drug administration up to two years
measure: Disease Control Rate (DCR)
timeFrame: from the frst drug administration up to two years
measure: Safety and tolerability
timeFrame: from the frst drug administration up to two years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03979898: Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP
Official title: Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Cerebral Palsy (CP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cerebral Palsy
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
Collaborators: name: Kyung Hee University Hospital at Gangdong
First posted: 2019-06-07
Enrollment: 1
Sex: ALL
Minimum age (years): 36
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP

Detailed description: The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Cerebral Palsy(CP)

Eligibility criteria: Inclusion Criteria:

* Children with spastic cerebral palsy of spastic paraplegia or quadriplegia involving the two side occurred at birth or before birth
* Age : 36 months - 12 year, males and females
* Subjects who understand and sign the consent form for this study
* Kaufman Assessment Battery for Children 50\<K-ABC\<100

Exclusion Criteria:

* The last three months had seizures or epilepsy patients taking the durg
* Genetic Diseases
* Recent cancer patients within 1 year
* patients witn a psychiatric disorder that may interfere in the clinical trial
* participating another clinical trials within 3 months
* Recently there is a change of the abrupt symptoms within three months of the patient
* Subjects with a infectious disease include HIV and VDRL
* Patients who penicillin hypersensitivity reactions
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Primary outcomes:
measure: Kaufman Assessment Battery for Children (K-ABC)
timeFrame: Baseline and 12 month
Secondary outcomes:
measure: Blood concentration test
timeFrame: Baseline, 1, 3, 6 and 12 month
measure: Gross Motor Function Measurement (GMFM)
timeFrame: Baseline, 3, 6 and 12 month
measure: Box and Block Test
timeFrame: Baseline, 3, 6 and 12 month
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline, 3, 6 and 12 month
measure: SF-36
timeFrame: Baseline, 3, 6 and 12 month
measure: Verification of ASTROSTEM's effect on the brain through fMRI & MRS (Magnetic Resonance Spectroscopy) scan
timeFrame: Baseline, 6 and 12 month
measure: Kaufman Assessment Battery for Children (K-ABC)
timeFrame: Baseline and 6 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KyungHee University Gandong Hospital
Study officials:
References:
Clinical trial NCT06159998: New Markers for Treatment Response to Radiotherapy in Prostate Cancer
Official title: New Markers for Treatment Response to Radiotherapy in Prostate Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Keywords: radiotherapy
markers
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men undergoing definite radiotherapy for prostate cancer.

Brief summary: The actual follow-up of patients undergoing definite radiotherapy for prostate cancer includes regular measurements of prostate specific antigen (PSA). Successful radiotherapy is critically dependent on local control of cancer; however, PSA takes 2-3 years to reach a nadir after therapy. We aim at collecting blood/urine after prostate massage before, and after radiotherapy in order to define new markers predicting local control earlier and more precisely than PSA.

Detailed description: Patients will be closely followed for 5 years (weeks 0, 2, 4, 6, and months 2, 3, 6, 9, 12, 18, 24, and then yearly). Each assessment includes PSA measurement, urine collection after prostatic massage, and blood collection.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing radiotherapy of biopsy confirmed clinically localised adenocarcinoma of the prostate

Exclusion Criteria:

* patients with inflammatory processes of the rectum
* patients with no rectum due to previous surgery

Primary outcomes:
measure: Bio-repository
timeFrame: first assessment using predifined markers after recruitment of 15 patients followed for 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Urology, University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Cyrill A Rentsch, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05278598: 3 Ultrasound Guided Plane Blocks for Perioperative Analgesia in Patients Undergoing Radical Cystectomy
Official title: Comparative Assessment of 3 Ultrasound Guided Plane Blocks for Perioperative Analgesia in Patients Undergoing Radical Cystectomy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Bladder
Surgery
Anesthesia
Analgesia
Block
Keywords: Erector spinae plane block
Quadratus lumborum plane block
Paravertebral block
Ultrasound-guided
Radical cystectomy
Analgesia
Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Radical cystectomy is the gold standard treatment for muscle invasive bladder cancer as well as some T1 and non-invasive disease. It is a major operation with significant perioperative morbidity and complications. Pain is one of the most important complications to be managed.

Regional blocks as a part of multi-modal analgesia are considered main strategies of Enhanced Recovery after Surgery (ERAS) decreasing post-operative complications including post-operative pain and post-operative hospital stay. They also have an upper hand over systemic intravenous opioids decreasing the risk for post-operative delirium specially in old age patients. Thoracic paravertebral plane block (TPVPB), intra muscular quadratus lumborum plane block (QLPB) and erector spinae plane block (ESPB) are among these regional anesthesia techniques for pain management.

Erector spinae plane block is an emerging block, with low risk and more feasibility, but efficacy hasn't been compared to quadratus lumborum and paravertebral plane blocks altogether in radical cystectomy surgeries.

All these blocks are effective in reducing postoperative pain and the need of analgesia in radical cystectomy surgery; this is a comparative study between the three blocks in this population.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class II - III.
* Adult patients scheduled for radical cystectomy.

Exclusion Criteria:

* Patient refusal.
* Uncooperative patients.
* Patients with known allergies to local anesthetics.
* Bleeding disorders or coagulopathy.
* Anatomical abnormality or infection at injection site.
* Patients receiving opioids for chronic analgesic therapy.
* Spinal anesthesia or any other regional anesthesia.

Primary outcomes:
measure: Morphine consumption.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
name: Moustafa M Zalat, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
name: Nazmy S Michael, MD
role: STUDY_DIRECTOR
References: