louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06012539: Nurses Caring for Patients With Covid-19
Official title: A Longitudinal Study of Clinical Nurses Caring for Hospitalized Adults With Covid -19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nurse
in Northern New Jersey
Providing Care to Adults With Covid-19
Keywords: nurses, interviews, caring for patients with Covid-19
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: RNs employed at the participating facility, cared for adult patients with Covid-19 in March-April 2020, consenting, participated in three private interviews (taped) over a period of 18 months.

Brief summary: The main goal of this study was to understand the perceptions of nurses who cared for patients with Covid-19 at the onset of the pandemic in Northeast USA. Private interviews were held three times with each participant, over the period of 18 months. The interviews were examined for common themes and expressions used by nurses to describe such topics as their professional image, memories, and advise to other nurses.

Detailed description: This study was conducted in a single institution. Forty-one (41) nurses were recruited from various units in the medical center. An effort was made to invite nurses from different clinical units, as well as inexperienced and experienced nurses, and males as well as females. To obtain variety in the participants a randomization list (list of names placed in order by a computer) was used to invite nurses. Participants consented and were aware that they would be interviewed three times. The interviews were recorded for transcription and subsequent analysis.

Eligibility criteria: Inclusion Criteria:

* RN employed by facility; cared for adult patients with Covid-19 from March - April 2000, consenting

Exclusion Criteria:

* not employed as an RN; did not care for patients with Covid-19 from March-April 2000 at designated facility, does not agree to consent

Primary outcomes:
measure: A longitudinal study of clinical nurses caring for hospitalized adults with Covid -19
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
Study officials:
References:
Clinical trial NCT00465439: Safety/Efficacy Study of Local Anesthetic Prior to Femoral Artery Sheath Removal
Official title: Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope, Vasovagal
Pain Intensity
Keywords: femoral artery sheath
vasovagal reaction
pain
perception
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2007-04-25
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial will examine the impact of local anesthetic on the frequency of vasovagal reactions and the patients perception of pain during femoral arterial sheath removal after percutaneous coronary intervention.

Detailed description: Patients undergoing percutaneous coronary intervention(PCI) will be randomized to receive subcutaneous local anesthetic (Lidocaine 2% without epinephrine)or no local prior to removal of femoral arterial sheath. They will be assessed for vasovagal reactions and pain intensity during the sheath removal.The incidence of vasovagal reactions and pain intensity scores will be compared between the groups. 200 patients will be enrolled over the course of 2 months.

Eligibility criteria: Inclusion Criteria:

* Percutaneous Coronary Intervention
* Femoral arterial sheath

Exclusion Criteria:

* Less than 18 years old
* Emergency procedure
* Transferred out of heart investigation unit prior to sheath removal
* Radial or brachial sheath
* Closure devise
* Venous sheath insitu
* Intra-aortic balloon pump insitu
* Tranvenous pacing
* Mechanical ventilation
* Cognitive impairment
* Unable to read English
* Lidocaine allergy

Primary outcomes:
measure: Incidence of vasovagal reaction during femoral sheath removal
timeFrame: During sheath removal
measure: Pain intensity during femoral sheath removal
timeFrame: During sheath removal
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Science-Heart Investigation Unit
state: Ontario
Study officials:
affiliation: Hamilton Health Science
name: Allison Cook, BScN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02069639: TARC After alloSCT in Hodgkin's Lymphoma
Official title: Serum Thymus and Activation-regulated Chemokine (TARC) Level Monitoring May Predict Disease Relapse Detected by PET Scan After Reduced Intensity Allogeneic Stem Cell Transplantation in Hodgkin's Lymphoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin's Lymphoma Patients Who Underwent an Allogeneic Stem Cell Transplantation
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included 22 consecutive Hodgkin's lymphoma patients who underwent an alloSCT at Fondazione IRCCS Istituto Nazionale dei Tumori and who were monitored by PET and TARC before and after alloSCT.

Brief summary: Relapsed and refractory Hodgkin's lymphoma (HL) patients may experience long-term survival after allogeneic transplant (alloSCT), but disease recurrence represents the main cause of treatment failure. PET (positron-emission tomography) -positive patients after alloSCT have a dismal outcome. Serum TARC (thymus and activation-regulated chemokine) is produced by Reed-Sternberg cells and may be a marker of disease. Our study was aimed at assessing whether TARC levels after alloSCT were correlated to disease status and whether TARC monitoring could increase the ability to predict relapse.


Eligibility criteria: Inclusion Criteria:

* Hodgkin's lymphoma patients who underwent an alloSCT at Fondazione IRCCS Istituto Nazionale dei Tumori and who were monitored by PET and TARC before and after alloSCT from 2009

Exclusion Criteria:

* Hodgkin's lymphoma patients who underwent an alloSCT who were not monitored by PET or/and TARC

Primary outcomes:
measure: Correlation between disease status and serum TARC level
timeFrame: One year after transplant
Secondary outcomes:
measure: The correlation between TARC levels and PET results after alloSCT
timeFrame: Before alloSCT, monthly during the first 6 months after alloSCT and every 2 months until 2 years of follow-up, then at the time of clinical check-up (usually every 6 months)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
References:
Clinical trial NCT01935739: Discordant HER2/Neu Status of Breast Cancer.
Official title: Discordant HER2/Neu Status Between Primary Tumor and Axillary Lymph Node in Breast Cancer Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm of Breast.
Lead sponsor: National Cancer Institute, Thailand
Sponsor class: OTHER_GOV
First posted: 2013-09-05
Enrollment: 105
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast Cancer Patients Stage I,II and III.

Brief summary: The purpose of this study is to determine discordant HER2/neu status of primary breast tumor and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer patients.

Detailed description: HER2/neu status of primary breast tumor and axillary lymph nodes were tested by IHC staining. In the cases of equivocal result of IHC, FISH test were performed.

The result of HER2/neu status between primary breast tumor and axillary lymph node were analyzed.

Eligibility criteria: Inclusion Criteria:

* Breast cancer patients stage I,II and III with axillary lymph nodes metastasis.

Exclusion Criteria:

* Breast cancer patients stage I,II and III without axillary lymph nodes metastasis.

Primary outcomes:
measure: Association of HER2/neu status between primary breast tumor and axillary lymph nodes
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: National Cancer Institute , Thailand.
state: Bangkok
Study officials:
affiliation: National Cancer Institute, Thailand
name: AKANIST PIYAPANT, MD.,FRCST.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.
citation: Cristofanilli M. The biological information obtainable from circulating tumor cells. Breast. 2009 Oct;18 Suppl 3:S38-40. doi: 10.1016/S0960-9776(09)70270-X.
Clinical trial NCT00764439: Pilot Study of a New Nicotine Replacement Therapy
Official title: Pilot Study on Usage Patterns of a Novel Nicotine Replacement Therapy - A Multi-Center, Open, 3-Week Randomized Low Intervention Study of Two Different Directions for Use in Smokers Motivated to Quit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 258
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: Pilot study of a new nicotine replacement therapy for smoking cessation.

Detailed description: This will be a pilot study of a new nicotine replacement therapy with two different directions for use in smoking cessation.

Eligibility criteria: Inclusion Criteria:

* 18 years or older male and female cigarette smokers motivated and willing to stop smoking
* female participants of child-bearing potential should use a medically acceptable means of birth control
* evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate

Exclusion Criteria:

* unstable angina pectoris or myocardial infarction during the previous 3 months
* pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential)
* participation in other clinical trials within the previous three months and during study participation

Primary outcomes:
measure: Mean hourly and daily number of doses used
timeFrame: throughout study
Secondary outcomes:
measure: Mean number of NRT use occasions per day
timeFrame: Week 1, 2, and 3
measure: Ratings of craving/urge to smoke and withdrawal symptoms
timeFrame: Day 1-14, and Day 20
measure: Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm
timeFrame: Day 1-21
measure: Cotinine levels
timeFrame: At baseline and week 3
measure: Product acceptability
timeFrame: At week 3 visit
measure: Safety Assessments will consist of monitoring and recording all non-serious Adverse Events and Serious Adverse Events , their frequency, severity, seriousness, and relationship to the investigational product.
timeFrame: throughout duration of the study (+ 30 days for spontaneous SAEs)
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Department of Primary Care and General Practice, University of Birmingham
city: London
country: United Kingdom
facility: Tobacco Dependence Research Centre at Barts and The London Queen Mary's School of Medicine and Dentistry
Study officials:
affiliation: Global Medical Affairs & Clinical Research, McNeil AB, Sweden
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00447239: The Effect of Intensive Insulin Therapy
Official title: The Effect of Intensive Insulin Therapy on the Incidence of Ventilator-Associated Pneumonia in Surgical Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: the Maintenance of Normoglycemia
the Incidence of Ventilator Associated Pneumonia (VAP)
Treatment Period in the Intensive Care Unit
Keywords: mechanical ventilated
surgical patients
pneumonia
blood glucose
insulin infusion
hospital stay
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2007-03-14
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim. To determine whether the maintenance of normoglycemia decreases the incidence of ventilator associated pneumonia (VAP), reduces its treatment period and the length of stay in the intensive care unit.

Methods. Prospective, randomized, controlled trial. We enrolled 117 mechanically ventilated trauma (71) and abdominal (46) surgical patients, older than 18, of both sex. In 57 patients (strict glucose control group) we aimed to maintain the blood glucose level between 4.4 and 6. 1 mmol/L, while in 60 patients (standard glucose control group) it was maintained between 7.8 and 10.0 mmol/L, with the use of continues insulin infusion. Insulin dose adjustments were based on measurements of glucose in capillary blood sample.

Key words: surgical patients; mechanical ventilation; pneumonia; blood glucose; insulin infusion; hospital stay

Detailed description: see brief summary

Eligibility criteria: Inclusion Criteria:

* surgical patients
* mechanical ventilated
* both sex
* older than 18

Exclusion Criteria:

* non-surgical patients
* non mechanical ventilated
* younger than 18
* pregnant women

Primary outcomes:
measure: measurements of glucose in capillary blood sample
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Clinical Centre Ljubljana
Study officials:
affiliation: Clinical Centre Ljubljana
name: Adela Stecher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05306639: Treatment of Monosymptomatic Nocturnal Enuresis
Official title: Effect of Spinal Magnetic Stimulation Versus Posterior Tibial Neuromodulation in Treatment of Monosymptomatic Nocturnal Enuresis: a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nocturnal Enuresis
Keywords: spinal magnetic stimulation, nocturnal enuresis, neuromodulation
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized trial to study the effect of spinal magnetic stimulation versus posterior tibial neuromodulation in the treatment of monosymptomatic nocturnal enuresis.

Detailed description: Nocturnal enuresis is defined as "nighttime bedwetting in children aged five years or older.Currently available treatment options for nocturnal enuresis include medication, wetting alarms, lifestyle changes, sacral magnetic stimulation, and posterior tibial neurmodulation.

Magnetic stimulation is a valid method for stimulation of sacral as functional electrical stimulation. It generates a more powerful and deeper electrical field than that produced by conventional electrical stimulators. So, magnetic stimulation could be considered an attractive form of electrical therapy, being relatively painless, non-invasive and free from side effects.Peripheral neuromodulation is the modulation of the physiologic behavior of the nerve by electrical stimulation. Posterior tibial neuromodulation is an effective method in treatment of urinary incontinence

Eligibility criteria: Inclusion Criteria:

* All subjects were diagnosed as patients with MNE according to the Diagnostic and statistical manual of mental disorders, 4th revised edition (DSM-IV) (American Psychiatric Association's DSM-IV, 1994): bed-wetting ≥3 times a week; lasting more than 6 months; can control urination during the day but cannot control urination after falling asleep.

Exclusion Criteria:

* - Patients younger than 5 years old.
* Patients who have any abnormality in blood or urine biochemistry.
* Patients with other urinary symptoms.
* Patients with neurological or endocrinal abnormalities (such as cerebral palsy, spinal cord lesion, peripheral neuropathy or diabetes mellitus)

Primary outcomes:
measure: Frequency of bed wetting
timeFrame: one month
measure: Visual analogue scale to determine how much the enuresis affected his/her life.
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Nehad ElShatby
Study officials:
affiliation: Alexandria University
name: Nehad ElShatby
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02749539: Post Mastectomy Shoulder Problems and Kinesio Taping
Official title: Investigating the Effect of Kinesio Tape Over the Conventional Physical Therapy Management of Shoulder Related Complications in Post-mastectomy Peri-menopausal Females: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Mastectomy Complications
Keywords: Mastectomy
Shoulder Pain
ROM
Kinesio Tape
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 70
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Applications of new treatment modality which is Kinesio tape in post mastectomy shoulder problems.

Detailed description: Post-mastectomy complications are often noted and complaints by breast cancer survivors. It often involves the development of chronic arm pain with accompanying limitation of shoulder motion. Aim of the study was to investigate the effect of the kinesio tape (KT) on the shoulder pain and range of motion (ROM).

Method: 74 female patients underwent modified radical mastectomy were involved in this study. They were randomly divided into two groups, experimental who received KT for shoulder joint in addition to conventional physiotherapy program while, the control group received the physiotherapy program only. Outcome measures were visual analogues scale, shoulder ROM and shoulder Pain and Disability Index.

Eligibility criteria: Inclusion Criteria:

* Underwent modified radical mastectomy for at least 2 weeks and taking chemotherapy and radiation therapy for stage 1 or II breast cancer.
* Presence of shoulder pain with associated limitation of motion of the shoulder.
* Good compliance and willingness to participate in kinesio taping sessions with a written consent

Exclusion Criteria:

* Still diagnosed with active breast CA at the time of the study.
* Presence of skin hypersensitivity to kinesio tape material.
* Presence of treatment contraindications including the presence of a pacemaker, heart disease, pregnancy, infectious disease, epilepsy thrombophlebitis, arterial hypertension or metastatic cancer .
* Presence of mental disturbances of the sensorium or language problems which can make communication and cooperation problematic.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 2 weeks change from the baseline scores
Secondary outcomes:
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: 2 weeks change from the baseline scores
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03732339: CTC in Predicting Neoadjuvant Chemotherapy Among LABC Patients: a Single-center, Prospective, Exploratory Clinical Trial
Official title: Predictive Value of Circulating Tumor Cells in Neoadjuvant Chemotherapy Among Locally Advanced Breast Cancer Patients: a Single-center, Prospective, Exploratory Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Locally Advanced Breast Cancer
Circulating Tumor Cell
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Viroad Biotechnology Co., Ltd.
First posted: 2018-11-06
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. The purpose of this clinical trial is to evaluate the predictive value of CTC in neoadjuvant chemotherapy among locally advanced breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed primary invasive breast adenocarcinoma, anatomic stage T2-4N0-3M0 or T1N1-3M0 before neoadjuvant chemotherapy
* ECOG 0-1
* Adequate organ function
* Consent to undergo CTC analysis in vivo

Exclusion Criteria:

* Pregnant or breastfeeding patients
* Metastatic or recurrent patients
* Uncontrollable infection

Primary outcomes:
measure: Predictive value of CTC in ypT0 ypN0
timeFrame: Change from pre-chemotherapy to 22-28(±7) days after first dose of neoadjuvant chemotherapy
Secondary outcomes:
measure: Predictive value of CTC in ypT0, ypT0/is ypN0, near pCR
timeFrame: before and 22-28(±7) days after first dose of neoadjuvant chemotherapy
measure: hypersensitivity
timeFrame: up to 1 year
measure: Detection rate of GILUPI CellCollector®
timeFrame: before and 22-28(±7) days after first dose of neoadjuvant chemotherapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Jinsong Lu
role: PRINCIPAL_INVESTIGATOR
References: