louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06920472: This Present Study Can be Used by Clinicians Who Treat Psychiatric Patients: Dentists Might Expect Xerogenic Side Effects of Specific Psychiatric Drugs Which Can Affect Dental Treatment, and the Results Can Help Psychiatrist to Choose the Less Xerogenic Psychiatric Medication
Official title: Xerogenic Potential of the Most Frequently Prescribed Psychiatric Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Disorders
Xerostomia Due to Hyposecretion of Salivary Gland
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient Clinic, Department of Psychiatry and Psychotherapy and Dental Teaching Center, Semmelweis University, Budapest, Hungary

Brief summary: The goal of this observational study is to learn about the effects of psychiatric drug therapies on intra- and extra-oral sicca symptoms and salivation. The main question that it aims to answer is:

Does taking psychiatric medication cause oral dryness and/or any changes on whole and minor saliva secretion? Participants taking psychiatric medication answered a 16-question questionnare, and their saliva production was measured by Periotron device and by spitting method.


Eligibility criteria: Inclusion Criteria:

In the psychiatric group, the inclusion criteria was taking specific psychiatric medications.

Exclusion Criteria:

In the control group the exclusion criteria was reporting any diseases and taking medicines.

Primary outcomes:
measure: Unstimulated whole saliva flow rate (UWS)
timeFrame: through study completion, an average of 1 year
measure: Minor salivary gland (MSG) secretions
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02090972: The Impact of Opioids in Fractures - a Case Control Study
Official title: Evaluation of Past Medications in Older Patients With Fractures and Patients Hospitalized for a Non-surgical Reason.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Mundipharma Research GmbH & Co KG
First posted: 2014-03-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitalized patients in University Hospital, surgical and internal department

Brief summary: In this study, the risk of opioid medications on fractures in older adults is investigated. Patients from the surgical department with fractures and control patients from the internal department of the same hospital are inquired with a standardized questionaire about demographic and clinical risk factors for fractures. Osteoporotic fracture risk is assessed using quantitative ultrasound. An impact of recent opioid medications on fractures is hypothesised.


Eligibility criteria: Inclusion Criteria for both groups:

* age \> 60 years
* written informed consent

Exclusion Criteria for both groups:

* malignant Disease within the last 12 month
* troubles with memory, dementia or Parkinsons disease
* other fractures within the last 6 month

Exclusion Criteria for the fracture group:

* alcoholised during the fall
* fracture older than 14 days

Primary outcomes:
measure: Reported Opioid medication before hospital admission
timeFrame: interview: 20 min
Secondary outcomes:
measure: Bone density measures using Quantitative ultrasound (SAHARA)
timeFrame: 10 min
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: BG University Hospital Bergmannsheil, Ruhr University Bochum
Study officials:
References:
Clinical trial NCT03427372: The Effect of Psychological State on Post Spinal Puncture Headache and Backache
Official title: The Effect of Anxiety and Depression Mood on Post Spinal Puncture Headache and Backache
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression, Anxiety
Lead sponsor: Ahi Evran University Education and Research Hospital
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18-80 years old American Society of Anesthesiology (ASA) I-III patients underwent spinal anesthesia

Brief summary: To investigate the effect of patient mood before spinal anesthesia on post spinal puncture headache and backache

Detailed description: Before spinal anesthesia patients' anxiety and depression mood will recorded with Beck anxiety and Beck depression scale fifteen minute before spinal anesthesia.Seven days after surgery post spinal puncture headache and backache will assess by a telephonic interview

Eligibility criteria: Inclusion Criteria:

* patient scehedule surgery under spinal anesthesia
* between 18-80 years old

Exclusion Criteria:

* patients with psychiatric disorders

Primary outcomes:
measure: post spinal puncture headache (PDPH)
timeFrame: one week after surgery
Secondary outcomes:
measure: anxiety
timeFrame: fifteen minutes before spinal anesthesia
measure: depression
timeFrame: fifteen minutes before spinal anesthesia
measure: post spinal puncture backache (PDPB)
timeFrame: one week after surgery
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Ahi evran university education and research hospital
Study officials:
affiliation: Ahi Evran University Education and Research Hospital
name: kevser peker
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peker K, Polat R. The effects of preoperative reactions of emotional distress on headache and acute low back pain after spinal anesthesia: A prospective study. J Psychosom Res. 2021 May;144:110416. doi: 10.1016/j.jpsychores.2021.110416. Epub 2021 Mar 11.
Clinical trial NCT03245372: Goal Directed Therapy Versus Standard Care in Lung Resection Surgery (GDT-thorax Study).
Official title: Goal Directed Therapy Versus Standard Care in Lung Resection Surgery, a Randomized, Controlled Trial (GDT-thorax Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Goal Directed Therapy
Fluid Therapy
Keywords: cardiac output
perioperative care
postoperative complications
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary aim of this study is to quantify and compare the hemodynamic control of cardiac index in patients who receive either goal-directed therapy or standard hemodynamic management in lung resection surgery

Detailed description: The investigators hypothesize that the percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2 is higher in goal directed therapy

Eligibility criteria: Inclusion Criteria:

* Adults patients ( 18 years old)
* Written informed consent
* Elective lung resection surgery (open or thoracoscopic lung lobectomy)

Exclusion Criteria:

* Severe obesity
* Moderate to severe aortic insufficiency
* Renal failure requiring hemodialysis
* Left ventricle ejection fraction less than 35 %
* Urgent surgery

Primary outcomes:
measure: Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%)
timeFrame: During the total duration of the surgery, on average 4 hours. We include the time from the start of maintenance of general anesthesia to the moment of extubation of the patient.
Secondary outcomes:
measure: Tissue Perfusion Marker: Lactate
timeFrame: Within 24 hours after lung surgery
measure: Tissue Perfusion Marker: SvcO2
timeFrame: Within 24 hours after lung surgery
measure: Oxygenation Marker: PaO2/FiO2 Ratio
timeFrame: Within 24 hours after lung surgery
measure: Fluid Balance
timeFrame: After 24 hours of finalization of lung surgery
measure: Observation of Acute Kidney Injury (AKI)
timeFrame: After 72 hours of finalization of lung surgery
measure: Observation of Acute Respiratory Distress Syndrome (ARDS)
timeFrame: Within 30 days after lung surgery
measure: Duration of Hospital Stay
timeFrame: Within 30 days after lung surgery
measure: Mortality
timeFrame: Within 30 days after lung surgery
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: University hospital Virgen del Rocío
Study officials:
affiliation: Andaluz Health Service
name: Manuel Bertomeu, MD-PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06542172: Impact of Low-fat and Full-fat Milk on Lipids and Cardiac Function in Patients With Coronary Artery Disease
Official title: Impact of Low-fat and Full-fat Milk on Lipids and Cardiac Function in Patients With Coronary Artery Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial aimed to investigate the effects of low-fat and full-fat milk on patients with coronary artery disease (CAD).

Detailed description: The effects of low-fat and full-fat milk on lipid profiles and sphingolipid profiles in CAD patients are not well understood. In addition, milk intake is at a low level in the Chinese population compared with developed countries. Therefore, we aimed to conduct a randomized controlled trial to investigate the effects of low-fat and full-fat milk on lipid profiles, sphingolipid profiles, and cardiac performance in Chinese CAD patients.

Eligibility criteria: Inclusion Criteria:

(1) Patients with CAD

Exclusion Criteria:

(1) patients \<18 years of age; (2) patients with systemic active infection; (3) patients with severe hepatic and renal dysfunction \[alanine aminotransferase (ALT) \> 135mmol/L, creatinine \> 200umol/L), or chronic lung disease; (4) patients with a life expectancy ≤ 6 months due to bleeding tendency and hematological diseases, malignant tumors, and end-stage diseases; (5) patients with valvular heart disease or left ventricular aneurysm who needed simultaneous surgeries; (6) patients with cerebrovascular disease (cerebral infarction or cerebral hemorrhage within 6 months before enrollment); (7) patients who enrolled in other drug intervention trials; (8) patients who received emergency percutaneous coronary intervention (PCI); and (9) patients who reported intolerance to lactose.

Primary outcomes:
measure: differences in lipids, sphingolipids, and cardiac function between the three groups after 12 weeks of intervention
timeFrame: after 12 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital Affiliated to Capital Medical University
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: Dongzhimen Hospital
city: Chongqing
country: China
facility: The Third Military Medical University of the Chinese people's Liberation Army
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
city: Nanjing
country: China
facility: Nanjing First Hospital
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: Chinese PLA General Hospital
name: Rong Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04572672: Effect of Pursed-Lip Breathing on Blood Pressure and Heart Rate
Official title: Effect of Pursed-Lip Breathing Combined With Number Counting on Blood Pressure and Heart Rate in Hypertensive Urgency Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertensive Urgency
Keywords: Hypertensive crisis
Uncontrolled hypertension
Mindfulness
Slow breathing
Emergency room
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a single-blinded randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: Hypertensive urgency (HT urgency) is an alarm sign of uncontrolled hypertension. It can be aggravated by nonadherent to medication and psychosocial stress. Mindfulness is beneficial for reducing stress, while deep and slow breathing is effective for blood pressure (BP) lowering. The objective of the study was to assess the effect of pursed-lip breathing with number counting (PLB with NC) that promotes mindfulness and a deep/slow breathing pattern on BP and heart rate (HR) in the HT urgency patients.

Detailed description: This was a single-blinded randomized controlled trial. Patients aged between 18-80 years old, diagnosed with HT urgency, who presented at the emergency room of Srinagarind hospital (a 1000-bed, tertiary-care level university hospital), Khon Kaen University between September 1st, 2019 to June 30th, 2020, were enrolled. Those with cardiac arrhythmias, acute HF, acute coronary syndromes, acute stroke, acute respiratory failure, alteration of consciousness, and pregnant women were excluded. This study was approved by the Khon Kaen University Ethical Review Board in Human Research (HE611586). All patients gave their written informed consent before the enrollment.HT urgency was defined as SBP \>180 mmHg and/or DBP \>110 mmHg without any signs or symptoms of target organ damages.

Eligibility criteria: Inclusion Criteria:

* 18-80 years old patients who diagnosed with HT urgency, who presented at the emergency room

Exclusion Criteria:

* Patients with cardiac arrhythmias,
* Acute heart failure
* Acute coronary syndromes
* Acute stroke
* Acute respiratory failure
* Alteration of consciousness
* Pregnant women

Primary outcomes:
measure: Change of systolic blood pressure
timeFrame: pre-intervention and 3 hours after the intervention
measure: Change of diastolic blood pressure
timeFrame: pre-intervention and 3 hours after the intervention
measure: Change of heart rate
timeFrame: pre-intervention and 3 hours after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen Unversity
Study officials:
References:
Clinical trial NCT04636372: Effect of Meibomian Gland Related Therapy on the Morphology of Meibomian Gland
Official title: Effect of Meibomian Gland Related Therapy on the Morphology of Meibomian Gland
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Xerophthalmia
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 200 participants at Eye Hospital of Wenzhou Medical University during September, 2020 to November, 2020 will be enrolled in this study. The meibomian gland related therapy are pulsed light therapy and meibomian gland hot compress massage.


Eligibility criteria: Inclusion Criteria:

* Previously untreated patients with xerophthalmia

Exclusion Criteria:

* No history of ocular surgery and trauma
* Any eye diseases except xerophthalmia
* No treated for xerophthalmia before
* Successful completion of follow-ups

Primary outcomes:
measure: The length of meibomian glands after the treatment.
timeFrame: up to 2 months
measure: The area of meibomian glands after the treatment.
timeFrame: up to 2 months
measure: The percentage of meibomian glands after the treatment.
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03049072: Ion Therapy Patient Registry
Official title: A Prospective Registry Study to Record Clinical Results and Side Effects of Ion Beam Therapy at MedAustron
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ion Beam Radiation Therapy for Tumor Patients
Lead sponsor: EBG MedAustron GmbH
Sponsor class: INDUSTRY
First posted: 2017-02-09
Enrollment: 2100
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: Patients treated with ion beam therapy at MedAustron

Brief summary: The purpose of the study is the prospective and standardized data collection of patients treated with ion therapy at MedAustron.

Detailed description: During and up to 10 years after radiation therapy data regarding tumor control and treatment response as well as acute and late toxicities will be collected at regular time intervals. Additionally quality of life and sociodemographic status will be assessed in all study patients and neurocognitive assessment will be performed in patients undergoing ion radiation of the brain.

Eligibility criteria: Inclusion Criteria:

* Patients with tumor disease treated with ion beam therapy at MedAustron
* Signed informed consent form

Exclusion Criteria:

* Comorbidities endangering treatment delivery or study compliance

Primary outcomes:
measure: Therapy response
timeFrame: 10 years
measure: Overall survival
timeFrame: 10 years
measure: Progression-free survival
timeFrame: 10 years
measure: Local progression-free survival
timeFrame: 10 years
measure: Cause-specific survival
timeFrame: 10 years
measure: Toxicity according to NCI CTCAE
timeFrame: 10 years
Secondary outcomes:
measure: EORTC-QLQ-C30
timeFrame: Through study completion, at 3, 5, and 10 years
measure: EORTC-QLQ-BN20
timeFrame: Through study completion, at 3, 5, and 10 years
measure: EORTC-QLQ-PR25
timeFrame: Through study completion, at 3, 5, and 10 years
measure: Neurocognitive test battery
timeFrame: Through study completion, at 3, 5, and 10 years
Other outcomes:
Locations:
city: Wiener Neustadt
country: Austria
facility: EBG MedAustron GmbH
state: Niederösterreich
Study officials:
affiliation: EBG MedAustron GmbH
name: Carola Lütgendorf-Caucig, MD MPH MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: EBG MedAustron GmbH
name: Piero Fossati, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00356772: Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers
Official title: Comparison of Azithromycin Level in Tears and in Conjunctiva After Repeated Instillations of T1225 1.5% Eye Drops or After a Single Per Os Administration of Zithromax® (Azithromycin 1g), in 36 Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eye Infections, Bacterial
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2006-07-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate azithromycin ocular conjunctiva concentrations 7 and 14 days after treatment initiation.

To assess ocular and systemic tolerance/safety and azithromycin tear concentrations on Day 7

Detailed description: The aim of the present study was to compare azithromycin tear and conjunctival ocular concentrations after one instillation of T1225 1.5% eye drops, twice a day during one day versus one instillation of T1225 1.5% eye drops, twice a day during 3 days versus an oral single dose of 1g azithromycin.

Eligibility criteria: Inclusion Criteria:

* Written informed consent;
* Healthy volunteers;
* Registered in the national register of healthy volunteers;
* Male or female aged from 18 to 45 years old;
* Able to understand the study instructions;
* Likely to comply with the study schedule and treatment;
* Normal subjective ocular symptoms, Schirmer test \> 10 mm in 5 min and corrected visual acuity \>= 6/10 in both eyes

Exclusion Criteria:

* Ocular trauma, infection or inflammation within the last 3 months;
* Blepharitis;
* Conjunctival hyperaemia (score \>= 2);
* Fluorescein-stained punctuations (score \>= 1b);
* Hypersensitivity to one of the products used in the study;
* Clinically relevant allergy;
* Medical or surgical history incompatible with the study;
* Recent acute illness;
* Ocular surgery, including LASIK, LASEK and PRK within the last 12 months;
* Other ocular lasers or Zithromax® or Azadose® within the last 3 months;
* Systemic antibiotics and ocular medications within the last month;
* Contact lenses within the last week;
* Any medication on Day 0 and during the study (except paracetamol and contraceptives).

Primary outcomes:
measure: Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.
measure: Azithromycin Tear Concentrations on Day 7.
Secondary outcomes:
measure: Tolerance
Other outcomes:
Locations:
Study officials:
affiliation: Centre de Pharmacologie Clinique - Clermont-Ferrand (France)
name: Claude DUBRAY, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05279872: A Study of Zanubrutinib in Patients With ITP
Official title: A Study of Zanubrutinib in Patients With Primary Immune Thrombocytopenia (ITP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Immune Thrombocytopenia
Bruton Tyrosine Kinase
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 20
Sex: ALL
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: This project was undertaken to evaluate the efficacy and safety of BTK inhibitor Zanubrutinib for the secondary treatment of adults with primary immune thrombocytopenia (ITP).

Detailed description: The investigators are undertaking a prospective trial of 10 adults with ITP in China. Zanubrutinib is administered as 80 mg po. qd for 6 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility criteria: Inclusion Criteria:

* Confirmed primary refractory ITP
* Platelet counts \<30×10\^9/L or with bleeding symptoms
* Willing and able to sign written informed consent

Exclusion Criteria:

* Secondary thrombocytopenia
* Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit
* HIV infection or hepatitis B virus or hepatitis C virus infections
* Malignancy
* Severe medical condition (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
* Nursing or pregnant patients
* Patients who are deemed unsuitable for the study by the investigator

Primary outcomes:
measure: Overall response (OR)
timeFrame: 6 weeks
Secondary outcomes:
measure: Complete response (CR)
timeFrame: 6 weeks
measure: Time to response
timeFrame: 6 weeks
measure: Bleeding events
timeFrame: 6 weeks
measure: Side Effects
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Insititute of Hematology, Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology
name: Xiao-Hui Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: