louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01612559: Safety Study of Kudiezi (a Chinese Medicine Injection) Used in Hospitals in China
Official title: A Registry Study on Safety Surveillance of Kudiezi (a Chinese Medicine Injection) Used in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Angina Pectoris
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Dongfang Hospital Beijing University of Chinese Medicine
First posted: 2012-06-06
Enrollment: 30000
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: An anticipated sample size was caculated in this study, about 30000. Patients using Kudiezi injection from 2012 to 2014 in more than 20 hospitals.

Brief summary: This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

Kudiezi is kind of Chinese Medicine injection used for treating coronary heart disease and angina pectoris in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.

Detailed description: It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.

A registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from Jan.2012 to Dec.2015.

Eligibility criteria Patients who will use Kudiezi injection in selected hospitals

Data will be collected in four aspects by four different forms as following:

Form A (blue): demographic information Form B (yellow): adverse drug events/reaction Form C (white): extracted information from hospital information system and laboratory information system Form D (red): personalized information

Eligibility criteria: Inclusion Criteria:

* Patients using Kudiezi injection from 2012 to 2014

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of participants with adverse events; incidence of Kudiezi'ADRs and identify factors that contributed to the occurrence of the adverse reaction
timeFrame: to assess Kudiezi's 'adverse event' and 'drug adverse reaction' during patients' hospital stay, administration information of Kudiezi will be registered every day. The registry procedure will last 3 years only for patients using Kudiezi.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yan M Xie, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01659359: The Effect of Virtual Reality Glasses on Pain and Anxiety
Official title: Vice-presidency for Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain and Anxiety
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In recent studies using virtual reality has been proposed as a non pharmacological methods for pain relief but until this time , its effects has not been assessed on pain and anxiety during episiotomy repair. To determine the effectiveness of virtual reality Glasses on pain and anxiety in Primiparity women during episiotomy repair.


Eligibility criteria: Inclusion Criteria:

* Iranian
* low risk pregnancy
* Apgar ≥ 7

Exclusion Criteria:

* vision or ear disorders
* History of motion sickness or headaches
* psychological disease or Addiction
* Prescribe narcotic or sedation 4hour prior to delivery.

Primary outcomes:
measure: Virtual reality glasses decreased pain and anxiety during episiotomy
timeFrame: up to 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04538859: A Prospective Study of Factors Related to Exacerbation and Mortality of Non-cystic Fibrosis Bronchiectasis in Hong Kong
Official title: A Prospective Study of Factors Related to Exacerbation and Mortality of Non-cystic Fibrosis Bronchiectasis in Hong Kong
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiectasis Adult
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 400
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: This is a prospective observational study of patients. We propose to recruit consecutive patients who are under care of the Respiratory Clinic at the Prince of Wales Hospital with the diagnosis of bronchiectasis defined by high-resolution Computed Tomography scan. Patients who recover from a recent admission the Prince of Wales Hospital with exacerbation of bronchiectasis will also be recruited.

Brief summary: Bronchiectasis is associated with repeated exacerbations which occurs at rates of 1.5-6.5 per patients per year, and are associated with an increased risk of admission and readmission to hospital, and high health care costs. In a local study carried out more than 10 years ago, idiopathic disease dominates and patients with bronchiectasis are mainly female with high hospitalization and mortality rates; 21.9 cases per 100,000 and 2.7 cases per 100,000 respectively. Moreover, exacerbation characterized by increases in symptoms requiring antibiotic treatment is associated with disease progression and significant mortality. Updated prevalence of this disease with the characteristics of etiology, clinical presentation and outcomes are needed to guide further management plan.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years or older
2. Clinically stable for at least 4 weeks prior to enrollment (defined as no symptoms of exacerbation, no requirement for supplemental antibiotic therapy)
3. Diagnosis of bronchiectasis defined by high-resolution computed tomography scan

Exclusion Criteria:

1. History of cystic fibrosis; hypogammaglobulinemia; allergic bronchopulmonary aspergilosis
2. Those who are unable to give consent

Primary outcomes:
measure: Number of bronchiectasis exacerbation
timeFrame: 5 years
Secondary outcomes:
measure: Mortality rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong
state: Please Select
Study officials:
References:
Clinical trial NCT03745859: Evaluation of a New Open Source Virtual Bronchoscope Navigation System
Official title: Fraxinus- Assessment of an Open Source Virtual Bronchoscopic Navigation System
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Bronchial Neoplasms
Keywords: Bronchoscopy
Navigation
Feasibility Studies
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: SINTEF Health Research
First posted: 2018-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patents with undiagnosed peripheral pulmonary lesion(s) who have been recommended for bronchoscopy

Brief summary: To evaluate the feasibility of the Fraxinus Virtual Bronchoscope Navigation (VBN) System in the bronchoscopic access to target lesions. The study emphasizes the system´s efficacy in diagnostics of peripheral pulmonary lesions and the ease of use for the operator.

Detailed description: Multi-center study. The study explores Fraxinus which is an open source, software only, simple guiding system for bronchoscopy. The system provides 3D maps with centerline-to-target information extracted from preoperative computed tomography. The ability of the system to guide a user to a peripheral target lesion will be evaluated. During bronchoscopy any established method for diagnostic sampling is allowed. User Evaluation will be essential to decide if the Fraxinus VBN System is beneficial in a clinical setting.

Eligibility criteria: Inclusion Criteria:

* referred to thoracic department in any of the participating hospitals with undiagnosed peripheral pulmonary lesion(s) not visible by bronchoscopy
* voluntary signed an informed consent

Exclusion Criteria:

* pregnancy
* Any patient that the Investigator feels is not appropriate for this study for any reason

Primary outcomes:
measure: Evidence if the Fraxinus VBN System has a role in the assessment of peripheral pulmonary lesions
timeFrame: 48 hours
Secondary outcomes:
measure: Diagnostic yield
timeFrame: 1 week
measure: Duration of procedure
timeFrame: 48 hours
measure: Adverse events
timeFrame: 48 hours
measure: Operators-reported satisfaction
timeFrame: 48 hours
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Hanne Sorger, md phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01986959: Periodontal Dressing After Surgical Crown Lengthening
Official title: Periodontal Dressing After Surgical Crown Lengthening: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Wound Healing Disturbance of
Periodontal Infection
Keywords: Periodontal Dressings
Surgical crown lengthening
Periodontal surgery
Lead sponsor: Franciscan University Center
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: There is controversy regarding the postoperative effects of periodontal dressing on the periodontium, pain and discomfort. The aim of the present study was to compare postoperative pain following surgical crown lengthening with and without the use of periodontal dressing.

Material and Methods: A blind, randomized, clinical trial was carried out with 36 patients. Following surgical crown lengthening, the individuals were randomly allocated to the periodontal dressing group (PDG) and control group (CG - non-placement of periodontal dressing). Pain and discomfort were analyzed using a visual analog scale (VAS), verbal scale (VS) and the number of analgesics consumed in seven days postoperatively. Postoperative infection, stability of the gingival margin and type of healing were also evaluated.


Eligibility criteria: Inclusion Criteria:

* need for surgical crown lengthening on only one tooth with need for proximal osteotomy;
* aged 18 years or older;
* absence of systemic disease;
* absence of periodontal disease at the site of surgical crown lengthening;
* no restrictions regarding the procedure;
* no need for antimicrobial prophylaxis.

Exclusion Criteria:

* failure to return for the postoperative evaluations;
* failure to fill out the charts correctly;
* occurrence of pulp alteration in the operated tooth following the procedure;
* occurrence of partial or total loss of the periodontal dressing;
* allergic reaction to periodontal dressing.

Primary outcomes:
measure: Position of the gingival margin
timeFrame: Seven days
Secondary outcomes:
measure: Local infection
timeFrame: seven Days
measure: Healing
timeFrame: Seven Days
measure: Pain and discomfort
timeFrame: Seven days
measure: Gingival bleeding
timeFrame: Seven days
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: School of Dentistry, Franciscan University Center
state: RS
Study officials:
References:
Clinical trial NCT04718259: The Use of Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.
Official title: Evaluation of the Intraoperative and PO Analgesic Outcome of Using Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Analgesia
Children, Only
Bupivacaine
Midazolam
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study will be carried on children undergoing lower abdominal surgeries. Patients will be randomly categorized into two study groups. Group A will include patients who will receive bupivacaine intrathecal injection without adjuvant. Group B will include patients who will receive bupivacaine and preservative-free midazolam.


Eligibility criteria: Inclusion Criteria:

* All children aged 3-12 years, assigned for lower abdominal and pelvic surgeries and will be ASA grade I after obtaining written fully informed parental consent.

Exclusion Criteria:

* Patients with congenital anomalies especially of the spine, infections in the skin of the back, had coagulopathy, or allergy to the study drugs and those whose parents refused to give the consent .

Primary outcomes:
measure: Duration of postoperative analgesia
timeFrame: 90 days
measure: Duration of analgesia
timeFrame: 90 days
measure: Post operative resolution of motor block
timeFrame: 90 days
measure: The level of Post operative sedation
timeFrame: 90 days
measure: PO hospital stay
timeFrame: 90 days
Secondary outcomes:
measure: The rate of procedural success
timeFrame: 90 days
Other outcomes:
Locations:
city: Jazan
country: Saudi Arabia
facility: Alemeis hospital ksa
Study officials:
References:
Clinical trial NCT05160259: Radial Visualization of the Foramen Arcuale Atlantis
Official title: Radial Visualization of the Foramen Arcuale Atlantis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Patients With Kimmerle's Anomaly
Keywords: Kimmerle anomaly, vertebral artery, craniovertebral insufficiency, computed tomography, transcranial Doppler
Lead sponsor: Samarkand State Medical Institute
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In patients diagnosed with Kimmerle's anomaly manifested themselves in the form of dizziness, various types of headache, mainly localized in the occipital region, nausea or flashing of flies before the eyes, in the rest - only cervicalgia

Brief summary: Hemodynamics in the craniovertebral zone is often disturbed under the influence of a spondylogenic factor A complication of such changes can be from a slight decrease in cerebral circulation to ischemic changes in the vascular bed The patients underwent complex radiation diagnostics of the craniovertebral region of patients with verified Kimmerle's anomaly (N = 62) All examined patients underwent multispiral computed tomography (CT), ultrasound Doppler and transcranial Doppler (TCD) of the vertebral arteries (VA) Studies of the developmental variant of the first cervical vertebra with the presence of a bony bridge have shown that Kimmerle's anomaly can occur in all age groups

Detailed description: The vaulted hole was found in all age groups (more in young and middle age) The detection rate was within 16 3% of cases, that is, it occurs in every 5-6 people According to TCD data, Kimmerle's anomaly affects blood flow and was most often detected on both sides of the atlas In the unilateral variant, the anomaly was noted only on the left side It was found that the main structural change in the cerebral vascular bed, according to ultrasound diagnostics, is a change in the straightness of the vertebral arteries in the transverse processes of the cervical spine, including the atlas It should also be borne in mind that due to the complexity and mobility of the structure, patients with dysfunction of the craniovertebral zone receive therapy from doctors of various profiles, which requires a comprehensive diagnosis of this problem

Eligibility criteria: Inclusion Criteria:

* patients manifested themselves in the form of dizziness, various types of headache, mainly localized in the occipital region, nausea or flashing of flies before the eyes, in the rest - only cervicalgia

Exclusion Criteria:

* acute stroke, brain tumor

Primary outcomes:
measure: Radial visualization of the foramen arcuale atlantis
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Samarkand
country: Uzbekistan
facility: Samarkand State Medical Institute
Study officials:
References:
Clinical trial NCT04238559: Use of the SWAMECO Questionnaire Basel
Official title: Use of the SWAMECO Questionnaire in the General Population to Detect Swallowing Difficulties
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Swallowing Difficulties
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 115
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: The project population is the general population.

Brief summary: A patient self-report questionnaire was developed that assesses subjective swallowing difficulties with medication intake, the SWAMECO questionnaire. It was validated in a highly specific population and will now be tested in the general population.

Detailed description: Based on a systematic literature review, a novel self-report questionnaire was developed in 2016 to assess subjective swallowing difficulties with medication intake and their practical consequences in ambulatory patients, the SWAMECO questionnaire. It consists of 30 items divided into 5 sections Complaints, Intensity, Localization, Coping strategies, and Adherence to medication. It was validated in people suffering from systemic sclerosis (SSc), a rare multisystem autoimmune disease that often leads to swallowing problems with food and liquids with progression. The aim of this study is now to validate the questionnaire in the general population. Patients presenting in the community pharmacy with a prescription of at least 3 different medications for a minimum of 3 months will fill in the questionnaire on site.

Eligibility criteria: Inclusion Criteria:

* aged 18 years or more
* is living in the community setting
* is receiving three or more medications for a period not less than three months, independently of the frequency of the intake

Exclusion Criteria:

* patients who are not able to provide written conformed consent will be excluded

Primary outcomes:
measure: swallowing difficulties assessed by Questionnaire
timeFrame: 5 minutes
Secondary outcomes:
measure: medication adherence assessed by Questionnaire
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel
state: Basel Stadt
Study officials:
affiliation: University of Basel
name: Isabelle Arnet, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02850159: Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease
Official title: Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 32
Sex: ALL
Minimum age (years): 20
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 the effect of dual-mode non-invasive brain stimulation (NIBS) with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex compared with rTMS alone in patients with Parkinson's disease (PD) with freezing of gait (FOG).

Detailed description: Patients in the dual-mode group underwent five consecutive daily sessions of dual-mode NIBS with simultaneous high-frequency rTMS and tDCS, whereas patients in the rTMS group underwent high-frequency rTMS with sham tDCS. Assessments of FOG, motor, ambulatory and cognitive function were performed three times: at baseline before NIBS, immediately after NIBS, and one week after cessation of NIBS.

Eligibility criteria: Inclusion Criteria:

* diagnosed as Parkinson's disease (PD) with freezing of gait
* walk independently without walking devices

Exclusion Criteria:

* pre-existing and active major neurological diseases other than PD
* a previous history of seizures
* implanted metallic objects that would contraindicate rTMS

Primary outcomes:
measure: Change of Freezing of Gait Questionnaire (FOG-Q)
timeFrame: Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chang WH, Kim MS, Park E, Cho JW, Youn J, Kim YK, Kim YH. Effect of Dual-Mode and Dual-Site Noninvasive Brain Stimulation on Freezing of Gait in Patients With Parkinson Disease. Arch Phys Med Rehabil. 2017 Jul;98(7):1283-1290. doi: 10.1016/j.apmr.2017.01.011. Epub 2017 Feb 11.
Clinical trial NCT00482859: Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome
Official title: Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia Syndrome
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2007-06-05
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with Fibromyalgia

Brief summary: The purpose of this week long study is to describe sleep and problems with sleep in women diagnosed with Fibromyalgia syndrome.

Detailed description: At least 50 women over 18 years of age are invited to volunteer in this study. Sleep quality and problems with sleep will be described using several kinds of measures. Questionnaires on sleep and Fibromyalgia will be completed by the volunteer. In addition, the volunteer will complete a sleep diary for at least 7 days and wear an Actiwatch (a wrist watch like device that measures sleep). At completion of the study, participants will be provided a print out of their sleep obtained from the Actiwatch.

Participants may not be in the study if they work night shift (11 pm - 7 am) or have been diagnosed with a condition called sleep apnea.

Participants need not live in Kentucky to participate in this study.

Eligibility criteria: Inclusion Criteria:

* Women 18 years old; diagnosed with Fibromyalgia;

Exclusion Criteria:

* Volunteer works night shift (11PM - 7AM);
* Volunteer has been diagnosed with sleep apnea.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Kentucky
name: Suzette L Sewell, RN MSN
role: PRINCIPAL_INVESTIGATOR
References: