louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01248325: A Study of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline (NaCl 09%) for the Relief of Nasal Obstruction
Official title: Clinical Trial Unicenter, Phase III, Randomized, Double-blind, Comparative to Evaluate the Efficacy, Tolerability and Superiority of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline Solution in the Relief of Nasal Obstruction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rhinitis
Sinusitis
Lead sponsor: Zurita Laboratorio Farmaceutico Ltda.
Sponsor class: INDUSTRY
First posted: 2010-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixty subjects will take part in this study. The subjects will be randomly assigned in a 1:1 ratio between the two arms of study. (Group A: Solution of Luffa Nasal Operculate 5mg/mL, Group B: saline).

The subjects will use the study medication or comparative, according to their randomization, for a treatment period of 3 to 7 days. A follow-up visit will be made 15 days after initiation of treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects of both sexes aged over 18 years.
* Presence of nasal congestion due to colds, rhinitis, influenza, sinusitis and acute or chronic sinusitis
* Sign the Informed Consent Form
* Comply the study requirements and attend to study visits
* Female subjects must have a NEGATIVE urine pregnancy test during the screening.

Exclusion Criteria:

* Known allergy to any study product component
* Subject pregnant, lactating or of childbearing potential and not using adequate and effective contraceptive
* Vasoconstrictor nasal topic or oral
* Use of a decongestant nasal whatever the route of administration
* Use of intranasal corticosteroids
* Use of antiallergic
* Use of medication containing atropine
* Subjects that are participating in another study or who participated in another study, less than 12 months
* Any subjects deemed unsuitable for study by the Principal Investigator
* Abuse of alcohol or illicit drugs

Primary outcomes:
measure: Improvement of nasal congestion
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
Study officials:
affiliation: Universidade Federal de São Paulo/Hospital São Paulo/Escola Paulista de Medicina/UNIFESP
name: Luis Gregório, doctor's
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01876225: Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy
Official title: Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Anxiety
Keywords: cervical biopsy
forced cough
pain
VAS scale
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
Collaborators: name: THERE ARE NO FUNDING SOURCES TO THE STUDY.
First posted: 2013-06-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The use of forced coughing during cervical punch biopsy may reduce pain \& discomfort associated with the procedure.

Detailed description: Pain and anxiety are associated with many medical procedures performed in ambulatory setting. Colposcopically guided punch biopsies are a standard procedure performed in women with abnormal cervical cytology, as a part of the diagnosis and treatment selection.

Coughing is thought to provide a distraction and to cause a momentarily increase in blood pressure, reducing pain perception.

Therefore, the present study is designed to compare pain associated with cervical punch biopsy and the effect of forced coughing on pain and pain perception.

Eligibility criteria: Inclusion Criteria:

- Women undergoing cervical punch biopsy

Exclusion Criteria:

* Women under 18 years old
* Women currently taking prescription pain medications
* Women who consumed pain medication up to 2 hours prior to the scheduled biopsy.
* Women who refuse to take part in the study

Primary outcomes:
measure: The pain associated with cervical biopsy
timeFrame: 10 minutes
Secondary outcomes:
measure: Length of cervical punch biopsy with and without cough intervention
timeFrame: 10 minutes
Other outcomes:
measure: Number of biopsies taken in a single session
timeFrame: 12 minutes
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: Lin Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Efraim Siegler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05728125: Pinpointing the Factors Affecting Clinical Trial Experiences of Glioblastoma Patients
Official title: An In Depth Study Evaluating The Experiences of Patients In Glioblastoma Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glioblastoma
Keywords: Glioblastoma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Glioblastoma patients who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Historically, clinical study participation has been biased toward certain demographics. However, there is a shortage of studies that delve into the underlying factors that influence patient participation, both positively and negatively.

Several people will be invited to enroll in this study so that it may collect a variety of data about glioblastoma clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

The data collected from this study will be analyzed and used to improve the experiences of future glioblastoma patients who are recruited for medical trials.


Eligibility criteria: Inclusion Criteria:

* Patient has self-identified as planning to enroll in a clinical trial
* Patient has been diagnosed with glioblastoma
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant

Primary outcomes:
measure: Number of patients who decide to participate in a glioblastoma clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in glioblastoma clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Wirsching HG, Galanis E, Weller M. Glioblastoma. Handb Clin Neurol. 2016;134:381-97. doi: 10.1016/B978-0-12-802997-8.00023-2.
citation: Omuro A, DeAngelis LM. Glioblastoma and other malignant gliomas: a clinical review. JAMA. 2013 Nov 6;310(17):1842-50. doi: 10.1001/jama.2013.280319.
citation: Luo C, Song K, Wu S, Hameed NUF, Kudulaiti N, Xu H, Qin ZY, Wu JS. The prognosis of glioblastoma: a large, multifactorial study. Br J Neurosurg. 2021 Oct;35(5):555-561. doi: 10.1080/02688697.2021.1907306. Epub 2021 Jul 8.
Clinical trial NCT05812625: Myo-kinetic Stretching Versus Post-isometrics Relaxation Exercise With Traction in Patients of Cervical Radiculopathy
Official title: Effectiveness of Myo-kinetic Stretching Exercises Versus Post-isometrics Relaxation Exercise With Traction in Patients of Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Radiculopathy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 68
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to examine the effectiveness of Myo-kinetic stretching exercises versus post-isometric relaxation exercise in patients with cervical radiculopathy. Convenient sampling technique will be used to enroll the patients. Patients will be screened on the basis of pre formulated eligibility criteria. Written Consent will be taken from each patient for participation in the trial. The calculated Sample size of this study will be 68 calculated through Epitool. Group A will receive conservative baseline treatment consisted of hot pack therapy for 10 minutes and traction for 8 minutes. Myo-kinetic stretching exercises and group B will receive conservative baseline treatment and post-isometric relaxation exercise. The assessment of patients will be done at baseline, 4th and 8th week. The outcomes from patients will be calculated by using Numeric Pain Rating Scale (NPRS), Goniometer and Neck Disability Index. The comparison between pre-treatment and post-treatment data will be done after 8th week. Data will be analyzed through SPSS 25.


Eligibility criteria: Inclusion Criteria:

* Duration of cervical pain more than 4 weeks.
* History of positive Spurling test

Exclusion Criteria:

* History of previous cervical surgery
* Cervical spine tumor.
* Rheumatoid arthritis, prolong steroid use and osteoporosis in cervical region.
* Cervical spine fracture.

Primary outcomes:
measure: Cervical Pain
timeFrame: 8 weeks
measure: Neck Disability
timeFrame: 8 weeks
measure: Cervical Range of motion
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Allied Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sahreen Anwar, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01061125: Implantable Loop Recorders in Post-atrial Fibrillation (AF) Ablation: RPAF-A
Official title: Implantable Loop Recorders in Post-AF Ablation: RPAF-A
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
implantable loop recorder
TTM
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting for atrial fibrillation ablation

Brief summary: This is a randomized pilot study, of post pulmonary vein isolation (PVI) patients to determine the clinical utility of the Implantable Loop Recorder. These type of patients either are monitored with weekly transtelephonic monitoring (TTM) or implantable loop recorder (ILR). The Medtronic Reveal XT loop recorder will be implanted at the time of the PVI or at the 3-4 month PVI follow-up visit and patient care will be managed based on randomization to a blinded or unblinded group. Outcome measures will be compared to aid in decision making regarding anticoagulation and overall post ablation clinical management.

Detailed description: This is a randomized pilot study, of post pulmonary vein isolation (PVI) patients to determine the clinical utility of the Implantable Loop Recorder. The Medtronic Reveal XT implantable Loop Recorder is a market released device indicated for patients with clinical syndromes or situations at increased risk of cardiac arrhythmias, and patients who experience transient symptoms that may suggest a cardiac arrhythmia. These type of patients either are monitored with weekly transtelephonic monitoring (TTM) or implantable loop recorder (ILR). Neither approach has been shown to be superior. As both approaches are currently being performed based on physician preference, the investigators propose to study and compare both approaches in a randomized fashion for evidence based practice. The Medtronic Reveal XT loop recorder will be implanted at the time of the PVI or at the 3-4 month PVI follow-up visit and patient care will be managed based on randomization to a blinded or unblinded group. Outcome measures will be compared to aid in decision making regarding anticoagulation and overall post ablation clinical management.

Eligibility criteria: Inclusion Criteria:

* atrial fibrillation
* Chads score \> or equal to 1

Exclusion Criteria:

* contraindication for ILR
* life expectancy less an 12 months
* pregnant women
* existing cardiac rhythm management (CRM) device

Primary outcomes:
measure: AF Burden Conventional Follow up
timeFrame: Weekly for five months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Walid Saliba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Oussama Wazni, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05041725: The Impact of Remimazolam for Postoperative Sedation on the Left Ventricular Systolic Performance in Cardiac Surgery
Official title: The Impact of Remimazolam on the Left Ventricular Systolic Performance for Cardiac Surgery: a Speckle Tracking Analysis of the Left Ventricular Strain Using Transthoracic Echocardiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study analyzes the impact of intraoperative Remimazolam infusion for postoperative sedation on the left ventricular global longitude strain (LV-GLS) patients undergoing cardiac surgery


Eligibility criteria: Inclusion Criteria:

* elective off-pump coronary artery bypass surgery

Exclusion Criteria:

* arrhythmia
* LV ejection fraction \< 50 %
* preoperative inotropic support

Primary outcomes:
measure: change of the left ventricular global longitudinal strain
timeFrame: 1 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05084625: PACED-digitized Support During Adjuvant Endocrine Therapy
Official title: PACED-Patient-centred Digital Support During Adjuvant Endocrine Breast Cancer Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Treatment Adherence
Quality of Life
Treatment Side Effects
Keywords: Digital support
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: ScientificMed Tech AB
name: AstraZeneca
name: Novartis Sverige AB
name: Bröstcancerförbundet
name: Stockholm South General Hospital
name: Capio St Gorans hospital
name: Karolinska University Hospital
First posted: 2021-10-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research team want to investigate whether digital support, an app under preventive hormonal breast cancer treatment can lead to less late side effects, better quality of life and increased adherence to treatment.

Detailed description: Patients with hormon receptor positive breast cancer and adjuvant endocrine treatment will be invited to participate in the study after adjuvant radiotherapy is completed. Participants will be randomised to 12 months of access to a digital support-an app-in addition to standard follow-up or standard follow-up. Research team want to investigate whether digital support under hormonal breast cancer treatment can lead to less late side effects, better quality of life and increased adherence to treatment.

Eligibility criteria: Inclusion Criteria:

* Hormone receptor positive breast cancer
* On adjuvant endocrine treatment 0-16 weeks ago

Exclusion Criteria:

* Cognitively impaired
* No access to a mobile phone or internet
* Not understanding Swedish

Primary outcomes:
measure: Difference between the two groups with regard to change in quality of life from baseline to 12 months measured by Questionnaires European Organisation for Research and Treatment for Cancer Quality of life C30 (EORTC QLQ C30).
timeFrame: Change from baseline to 12 months
measure: Difference between the two groups with regard to change in quality of life from baseline to 12 months by Questionnaires European Organisation for Research and Treatment for Cancer Quality of life Breast cancerrelated 23 (EORTC QLQ BR23)
timeFrame: Change from baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Oncology department Capio St Gorans Hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: St Gorans Hospital
name: Jenny Bergqvist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02384525: The Assessment of Volume Status by BIA and Lung Ultrasound in Septic AKI Patients Undergoing CRRT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Acute Kidney Injury
Keywords: Septic AKI
CRRT
BIA
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 218
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute kidney injury(AKI) is one of the most common complications that occur up to 35% of critically ill patients. Septic AKI accounts for one third of them. Patients with septic AKI are widely treated with Continuous renal replacement therapy (CRRT). However, previous studies have hardly documented improvement of mortality in septic AKI patients. Otherwise, Fluid overload in septic shock patients who are undergoing CRRT is proven to be a significant predictor for mortality. Recent studies showed efficacy of bioelectrical impedance analysis and lung ultrasound in assessing fluid status of the patients. Thus, hypothesis of the study is that fluid assessment and control of fluid status using BIA and Lung Ultrasound could be related to the outcome of septic AKI patients who undergo CRRT. In this study, the investigators measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound for experimental group, while for control group, fluid status would be determined clinically by the physician. Ultrafiltration rate of experimental group is adjusted to be equal to the value of overhydration measured by BIA.


Eligibility criteria: Inclusion Criteria:

1. body temperature \< 36 °C or \> 38 °C
2. heart rate \> 90 BPM
3. respiratory rate \> 20 or aPaCO2 \< 32 mmHg on ABG
4. White blood cell count \< 4,000 cells/mm3 or \> 12,000 cells/mm3 or band forms (immature white blood cells) ≥10%
5. Evidence of infection
6. WBCs in normally sterile fluid
7. Perforated viscus
8. radiologically proven infection
9. more than Injury stage in AKI according to RIFLE criteria
10. septic AKI which is not explained by other cause
11. patients signed a written informed consent.

Exclusion Criteria:

1. Younger than 19 years old, older than 80 years old
2. Previously undergoing dialysis treatment due to ESRD
3. Underlying malignancy, Life expectancy shorter than 3 month
4. AKI due to other than sepsis
5. patients with intracardiac device such as Pacemaker, CRT, ICD

Primary outcomes:
measure: 28-day all cause mortality
timeFrame: 28th day from CRRT
Secondary outcomes:
measure: Dialysis free rate
timeFrame: 9 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT04338425: Patient Satisfaction With Postoperative Communication Modality
Official title: Patient Satisfaction With Postoperative Communication Modality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Communication between a surgeon and a patient in the immediate postoperative period is thought to influence patient satisfaction. There is currently no standard of care regarding the optimal form of postoperative communication, nor is there a consensus in our department as to which modality is preferred by patients.The purpose of this study is to determine which form of communication, if any, is preferred by patients. Furthermore, this study aims to evaluate the impact that various forms of communication during the immediate postoperative period have on patient (subject) satisfaction. The study hypothesizes that patient (subject) satisfaction with their surgeon will be highest among those who communicate with their surgeons via videotelephony (i.e., videoconferencing) and that the lowest satisfaction will be among patients (subjects) who did not communicate with their surgeon until their regularly scheduled postoperative office visit. The results of this study may help identify low cost methods for increasing patient satisfaction.

Detailed description: This is a prospective, randomized study designed to evaluate the effects of different communication modalities between surgeons and patients (subjects) in the immediate postoperative period. Given the nature of the study, it is not possible for either the surgeons or the subjects to be blinded. To reduce bias that may occur due to each surgeon's personal preference for postoperative communication modality, the surgeons (rather than individual subjects) will be randomized to one of the three communication modality groups (no communication on the day of surgery, voice call, or videoconferencing).

Eligibility criteria: Inclusion Criteria:

* undergoing surgery at the NYU Langone Orthopedic Center

Exclusion Criteria:

* Under the age of 18 years old

Primary outcomes:
measure: Percent of participants' satisfaction with surgeon
timeFrame: post operative office visit (1 week after surgery)
Secondary outcomes:
measure: Percent of participants' satisfaction with hospital experience
timeFrame: post operative office visit (1 week after surgery)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Eric Strauss, MD
role: PRINCIPAL_INVESTIGATOR
References: