louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03738930: Effectiveness of Artificial Intelligent Based mHealth System to Reduce ACS Patients Bleeding Events After PCI
Official title: Effectiveness of Artificial Intelligent Based mHealth System(Chronic Disease Management System) to Reduce ACS Patients Bleeding Events After PCI: Parallel Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Bleeding
Keywords: Acute Coronary Syndrome
Percutaneous coronary intervention
Bleeding
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 420
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: The present study was designed to observe the effectiveness of artificial intelligent based mHealth system(Chronic disease management system) to reduce bleeding events in ACS patients undergoing PCI.


Eligibility criteria: Inclusion Criteria:

age≥18 years, male or female; confirmed acute coronary syndrome patients; undergo percutaneous coronary intervention (PCI) treatment; good command of smart phones agree to participate in this clinical study and sign a written consent form.

Exclusion Criteria:

ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure; patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements; pregnant women or lactating women; investigators consider patients who were not suitable for participation with other reasons

Primary outcomes:
measure: the incidence of major bleeding during each visit between normal group and smartphone based group
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: The General Hospital of PLA
state: Beijing
Study officials:
affiliation: The General Hospital of PLA
name: Yundai Chen, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000830: Intracellular Pharmacokinetics of Zidovudine Triphosphate in Maternal and Infant Cord Blood Mononuclear Cells.
Official title: Intracellular Pharmacokinetics of Zidovudine Triphosphate in Maternal and Infant Cord Blood Mononuclear Cells.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Pregnancy
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY

Brief summary: To determine the levels of zidovudine triphosphate ( AZT-TP ) in maternal and fetal cord blood mononuclear cells. To determine the ratio of AZT-TP to endogenous nucleoside triphosphate levels in maternal and fetal cells. To determine the extent of drug transfer through the feto/placental unit.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Univ of Medicine & Dentistry of New Jersey / Univ Hosp
state: New Jersey
city: New York
country: United States
facility: Bellevue Hosp / New York Univ Med Ctr
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr / Pediatrics
state: New York
city: Memphis
country: United States
facility: Regional Med Ctr at Memphis
state: Tennessee
city: Memphis
country: United States
facility: Saint Jude Children's Research Hosp of Memphis
state: Tennessee
city: San Juan
country: Puerto Rico
facility: San Juan City Hosp
Study officials:
name: Fridland A
role: STUDY_CHAIR
name: Flynn P
role: STUDY_CHAIR
References:
citation: Rodman JH, Flynn PM, Robbins BL, Blanchard S, Jimenez E, Rodriguez J, Fridland A. Zidovudine pharmacokinetics and intracellular pharmacology of zidovudine in HIV-infected women and newborn infants. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:146 (abstract no 419)
Clinical trial NCT02916030: Vitamin D and Stroke
Official title: Vitamin D and Stroke: A Comparative Study to Risk Factors and Stroke Type
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Vitamin D
Stroke
Parathormone
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with first -ever acute onset stroke within seven days

Brief summary: Stroke remains one of the most devastating neurological diseases, often causing death, or gross physical impairment. It is the second most common cause of death worldwide and a major cause of acquired disability in adults.Vitamin D deficiency has been reported to contribute to the risk of cardiovascular disease especially stroke.

Detailed description: This case -control observational prospective study will conducted on fifty patients with first -ever acute onset stroke within seven days (25 patients with hemorrhagic stroke and 25 patients with ischemic stroke )

Eligibility criteria: Inclusion Criteria:

* Onset is within one week
* Confirmed stroke by brain CAT and / or MRI scan either haemorrhage or infarction

Exclusion Criteria:

* Cognitive and mental changes
* Recurrent stroke
* Hepatic and renal impairment
* Endocrinal diseases
* Steroid therapy
* Vitamin D or Ca supplementation
* Previous fractures
* Bone diseases
* brain neoplasm,
* Autoimmune diseases
* History of acute and chronic inflammatory diseases
* Malignancy,
* Trauma
* Surgery
* Acute vascular diseases that occurred within four weeks prior the onset of stroke
* History myocardial infarction ˂3 months.

Primary outcomes:
measure: serum 25 (OH) D levels
timeFrame: Within the first 24 hours
Secondary outcomes:
measure: Stroke severity
timeFrame: Within the first 24 hours
measure: Stroke etiology
timeFrame: Within the first 24 hours
measure: Stroke risk factors
timeFrame: Within the first 24 hours
measure: Stroke subtypes
timeFrame: Within the first 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: associate professor of anesthesia and critical care
name: sayed abd elshafy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04712630: Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft
Official title: Clinical and Radiographic Outcomes of the Apical Approach in Periodontal Surgery Reconstruction With and Without Graft Materials: Non-Incised Papillae Surgical Approach (NIPSA). A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Periodontal Diseases
Periodontal Pocket
Periodontal Attachment Loss
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 24
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: This study compared the clinical outcomes of the non-incised papila surgical approach (NIPSA) alone and with grafting biomaterial.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with periodontitis.
* plaque index and bleeding index of \< 30%.
* periodontal lesions with pocket probing depth \> 5 mm.
* intrabony defect \> 3 mm.
* intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.

Exclusion Criteria:

* patients with systemic diseases that contraindicated treatment.
* third molars.
* teeth with incorrect endodontic or restorative treatment.

Primary outcomes:
measure: Probing pocket depth (PD)
timeFrame: 12 months
measure: Clinical attachment level (CAL)
timeFrame: 12 months
measure: Recession (REC)
timeFrame: 12 months
measure: Location of the tip of the papillae (TP)
timeFrame: 12 months
measure: Keratinized tissue width (KT)
timeFrame: 12 months
measure: Bleeding on probing
timeFrame: 12 months
Secondary outcomes:
measure: Supra-alveolar attachment gain (SUPRA-AG)
timeFrame: 12 months
measure: Wound closure (WC)
timeFrame: 1 week
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Centro Odontologico Del Sureste Slp
Study officials:
References:
citation: Moreno Rodriguez JA, Caffesse RG. Nonincised Papillae Surgical Approach (NIPSA) in Periodontal Regeneration: Preliminary Results of a Case Series. Int J Periodontics Restorative Dent. 2018;38(Suppl):s105-s111. doi: 10.11607/prd.3195.
citation: Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Periodontal reconstructive surgery of deep intraosseous defects using an apical approach. Non-incised papillae surgical approach (NIPSA): A retrospective cohort study. J Periodontol. 2019 May;90(5):454-464. doi: 10.1002/JPER.18-0405. Epub 2018 Nov 28.
citation: Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22.
citation: Moreno Rodriguez JA, Ortiz Ruiz AJ. Apical approach in periodontal reconstructive surgery with enamel matrix derivate and enamel matrix derivate plus bone substitutes: a randomized, controlled clinical trial. Clin Oral Investig. 2022 Mar;26(3):2793-2805. doi: 10.1007/s00784-021-04256-1. Epub 2021 Nov 17.
Clinical trial NCT04647630: Evaluation of Streptococcus Pneumoniae Serotypes Prevalence Using a Urinary Kit
Official title: Prospective Study to Evaluate Streptococcus Pneumoniae Serotypes Prevalence in Community Acquired Pneumonia in Hong Kong Using a Urinary Kit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Community-acquired Pneumonia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults hospitalized with pneumococcal community acquired pneumonia (CAP)

Brief summary: This is an epidemiology study for the prevalence and serotypes of pneumococcus pneumoniae in hospitalized patients with community acquired pneumonia (CAP). The serotypes of the pneumococcus pneumoniae will be determined by a urinary antigen assay. This is a single center, non-interventional observatory study.

Detailed description: Patients admitted to the medical wards with a provisional diagnosis under "pneumonia","chest infection" or "fever" will be screened by research assistants.

Patients eligible with the inclusion criteria will be recruited into the study. Informed consent will be signed for those patients willing to participate in the study. Patient will be asked to save approximately 40 ml of urine. The urine sample will be processed in local laboratory and shipped out to a commercial lab for detection of any pneumococcal pneumoniae, and if present, serotyping will be performed at the same time using the same urine sample by urinary antigen assay. Meanwhile patients will be managed as usual by their clinical teams. Investigations and treatment will be offered by the clinical team as deemed necessary. The study team will only perform collection of urine and will not interfere the clinical management of the patients.

Positive results would be informed to the clinical teams for the appropriate action.

Eligibility criteria: Inclusion Criteria:

* Admitted with signs and symptoms suggestive of pneumonia

Exclusion Criteria:

* 1. Nosocomial pneumonia which is acquired \>= 48 hours after hospital admission. 2. Pneumonia which are already known to be caused by pathogens other than pneumococcus pneumoniae.

Primary outcomes:
measure: Determine the prevalence of pneumococcal serotypes in adults hospitalized
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
Study officials:
References:
Clinical trial NCT02232230: A Multicenter Trial Enrolling Men With Advanced Prostate Cancer Who Are to Receive Combination Radiation and Sipuleucel-T
Official title: A Multicenter Trial Enrolling Men With Advanced Prostate Cancer Who Are to Receive Combination Radiation and Sipuleucel-T
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Castrate Refractory Metastatic Prostate Cancer (mCRPC)
Lead sponsor: GenesisCare USA
Sponsor class: OTHER
Collaborators: name: Dendreon
First posted: 2014-09-05
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with castrate refractory metastatic prostate cancer (mCRPC).

Brief summary: Radiation in combination with Provenge based immunotherapy may improve outcomes seen on imaging as well as immunologic monitoring. This study will assess the effect of radiation therapy to augment anti-tumor responses from immune therapy with Provenge.

Detailed description: It is common knowledge that the host can make anti-tumor immune responses, although often these are ineffective in causing tumor regression. Boosting these responses with immunotherapy is therefore an attractive, relatively benign adjunctive cancer treatment. Little is known in regards to how standard anti-cancer therapies like radiation therapy might interact with immunotherapy in a clinical setting. We are interested in knowing if the tumor cell death occasioned by radiation therapy might augment anti-tumor responses from the immune therapy, Provenge.

The tentative assumption is that cell death following radiation therapy will stimulate anti-tumor immunity, which could provide a more permanent solution to curing cancer and discouraging tumors from spreading throughout the body. In order to find out if this assumption is correct, for patients undergoing radiation 28 days prior to Provenge, highly developed, laboratory analyses for tumor-specific immunity and imaging will be performed.

Eligibility criteria: Inclusion Criteria: Subjects will be recruited from the population of patients who are castrate refractory metastatic prostate cancer (mCRPC) and have made the decision to be treated with radiation therapy to one or more metastatic sites of concern followed at least 28 days later by Provenge.

Exclusion Criteria: The potential subject is unwilling or hesitant to participate for any reason and/or fails to complete the appropriate Informed Consent Form.

Primary outcomes:
measure: Change in immune stimulation
timeFrame: At 52 Weeks post first injection of sipuleucel-T
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: 21st Century Oncology
state: Arizona
Study officials:
affiliation: GenesisCare USA
name: Steven Finkelstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01808430: Powered Echelon Device in VATS Surgery
Official title: Real World Outcomes of Video-Assisted Thoracoscopic Surgery for Lung Cancer Using ECHELON FLEX™ Powered ENDOPATH® Stapler: a Prospective European Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: NSCLC
Lead sponsor: Ethicon Endo-Surgery (Europe) GmbH
Sponsor class: INDUSTRY
First posted: 2013-03-11
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for VATS lobectomy for histologically confirmed Non-Small Cell Lung Cancer (NSCLC) or scheduled for VATS wedge resection for undiagnosed pulmonary nodule or metastasis from colorectal cancer (CRC) in accordance with their institution's Standard-of-care (SOC).

Brief summary: This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices).

Detailed description: The European prospective observational multi-center cohort study aims to collect real-world outcomes of consecutive patients scheduled for VATS lobectomy for histologically confirmed Non-Small Cell Lung Cancer (NSCLC) or scheduled for VATS wedge resection for undiagnosed pulmonary nodule or metastasis from colorectal cancer (CRC) in accordance with their institution's Standard-of-care (SOC).

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed NSCLC (up to and including Stage II) for patients undergoing VATS lobectomy. For patients undergoing wedge resection for undiagnosed pulmonary nodule or metastasis from CRC, a malignant diagnosis may be confirmed post-operatively.
* Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung
* Willing to give consent and comply with evaluation and treatment schedule
* At least 18 years of age

Exclusion Criteria:

* Active bacterial infection or fungal infection
* Systemic administration (intravenous or oral) of steroids (within 30 days prior to study procedure)
* Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure
* Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g. port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
* Prior history of VATS or open lung surgery

Primary outcomes:
measure: occurrence and duration of post-operative air leak
timeFrame: prolonged air leak defined as longer than 5 days post-op
Secondary outcomes:
measure: volume of estimated intra-operative blood loss
timeFrame: blood loss intra-op and up to 5 days post-op
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Professor Peter Licht
Study officials:
affiliation: Ethicon Endo-Surgery (Europe) GmbH
name: Goran Ribaric, MD, MSc, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05152030: The Clinical Applicability of the 'TIB' Olfactory Test Device
Official title: Validation of the Local Applicability of the 'TIB' Olfactory Test Device in the Era of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anosmia
Hyposmia
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normosmic group were from community. Hyposmic and anosmic patients were from out patient clinic department of Otorhinolaryngology.

Brief summary: The aim of this study was to evaluate the validity and test-retest reliability of the 'TIB' Olfactory Test Device, a new olfactory test tool developed by Top International Biotech, Taipei, and to determine its normative values. The olfactory function of 180 subjects was evaluated using both the traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC) and TIB. The subjects consisted of 60 healthy volunteers (normosmic group), 60 hyposmic patients, and 60 anosmic patients. The healthy volunteers were retested with the UPSIT-TC and TIB at an inter-test interval of at least 7 days. The cut-off scores of TIB among the different groups were determined by receiver operating characteristic curve.


Eligibility criteria: Inclusion Criteria:

* Normosmic group were self-reported absence of deficits in olfaction. Hyposmic patients were loss of olfactory function with a phenyl ethyl alcohol (PEA) odor detection threshold below -1. Anosmic patients were loss of olfactory function with a PEA threshold equal to -1.

Exclusion Criteria:

* History of sinonasal symptoms within a week before the test

Primary outcomes:
measure: validity of TIB olfactory test
timeFrame: 30 minutes to 1 hour
measure: Reliability of TIB olfactory test
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Rong-San Jiang, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06631430: A Study to Test How Well Different Doses of BI 3810477 Are Tolerated by Healthy Men
Official title: Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3810477 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3810477 in healthy male subjects.


Eligibility criteria: Inclusion criteria

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 60 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
4. Signed and dated written informed consent in accordance with international conference on harmonization-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
5. Male subjects who are willing to use condoms to prevent unintended exposure of their partner (both, male and female) from time point of administration of trial medication until completion of the trial

Exclusion criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 100 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Further exclusion criteria apply

Primary outcomes:
measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
timeFrame: Up to Day 85
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: Up to Day 85
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: Up to Day 85
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: SGS Life Science Services - Clinical Research
Study officials:
References: