louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03625700: Supplementary Oxygen in Surgical and Medical Wards Evaluated by 30-day Mortality
Official title: Supplementary Oxygen in Surgical and Medical Wards in the Capital Region of Denmark Evaluated by 30-day Mortality, a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygen Toxicity
Oxygen Deficiency
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 11196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study is made up of four main population groups, each group having their specific vulnerabilities, thus making the main outcome (30-day mortality) more likely to occur than in the background population.

The four groups are:

1. Patients undergoing laparotomy (open abdominal surgery)
2. Patients undergoing orthopedic surgery due to hip fracture
3. Patients admitted to hospital due to chronic obstructive pulmonary disease in exacerbation
4. Patients admitted to hospital with acute mycardial infarction

Brief summary: This study evaluates the use and effects of supplementary oxygen in surgical and medical wards on patients admitted to a hospital in the capital region of Denmark. The population will be divided in to three groups according to their oxygenation status. The main outcome will be 30-day mortality, with secondary outcomes being Length of stay, 30-day admission to ICU, 30-day reoperations, 30-day readmission, and peak values within 30-days of C-reactive protein, S-Creatinine, Troponin.


Eligibility criteria: Inclusion Criteria:

* Admission date between 1st of January 2014 to 29th of December 2014 on a hospital in the capital region of Denmark
* Age ≥18
* Unique (first) admission in database for either:
* Hip fracture requiring surgery
* Chronic obstructive pulmonary disease in exacerbation
* Acute mycardial infarction
* Open abdominal surgery

Exclusion Criteria:

* No data on saturation within 48 hours after
* Admission (Medical patients)
* Discharge from the post anaesthesia care unit (Surgical patients)
* No data on primary outcome (30-day mortality)

Primary outcomes:
measure: 30- day mortality
timeFrame: 30 days
Secondary outcomes:
measure: Length of stay
timeFrame: 30 days
measure: Organ markers in blood samples
timeFrame: 30 days
measure: 30- day admission to ICU
timeFrame: 30 days
measure: 30- day readmission
timeFrame: 30 days
Other outcomes:
Locations:
city: København
country: Denmark
facility: Bispebjerg og Frederiksberg Hospital
state: NV
Study officials:
References:
Clinical trial NCT05285800: To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP
Official title: To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemodynamic Instability
Lead sponsor: Hamdard University
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 60
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In Both the groups after injecting 0.5% hyperbaric Bupivacaine intrathecally the outcomes are monitored and compared.
Primary purpose: TREATMENT

Brief summary: To determine the effectiveness of saddle block vs spinal anesthesia in TURP.

Detailed description: This study is being conducted to determine the effectiveness of saddle block vs spinal anesthesia in terms of haemodynamic stability and Vasopressor usage.

Eligibility criteria: Inclusion Criteria:

* Patient with absolute contraindication of general anaesthsia
* Patients who gave consent and willing to be included in study
* Patient's having age range between 45 years to 65years
* Well controlled diabetes and hypertension
* ASA grade I \& II

Exclusion Criteria:

* Patients with absolute contraindications of regional anesthesia,
* Deformity of vertebral column,
* Thyroid disorder,
* Psychiatric illness,
* Neurological diseases,
* Alcohol addiction,
* Smoking,
* Ischemic heart diseases and
* Not willing to participate

Primary outcomes:
measure: Haemodynamic status
timeFrame: Haemodynamic status checked from 0minutes ( as the patient takes supine position) for every 5minutes interval till the end of surgery.
measure: Vasopressor usage
timeFrame: Blood pressure is taken from 0minute (as the patient takes supine position) at every ⁵minutes interval till the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr. Muhammad Wajid Iqbal
state: Sindh
Study officials:
affiliation: Hamdard University
name: Dr. Wajid Iqbal, MBBS, MCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04326400: Active Monitoring And Determinants of Incidence Infection of COVDI-19
Official title: Active Monitoring And Determinants of Incidence Infection of COVDI-19 in a Hospital Population (AMADIICH) Study Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Infection
Lead sponsor: Fundación Teófilo Hernando, Spain
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in the maximum number of subjects willing to participate and able to understand and sign the informed consent form.

Brief summary: 7. Objectives To apply e-health methods to perform active monitoring and assess determinants of incident Infection of COVID-19 in a hospital population.

8. Study design Prospective, Single-centre, observational clinical study. 9. Disease or disorder under study Healthy people in risk of COVID-19 infection. 10. Main variable. Symptoms related to infection caused by SARS-Cov2. 11. Study population and total number of patients Men and women in general god health status aged between 18 and 80 years that currently are employees of Hospital de La Princesa .

12. Duration of treatment Each subject will be monitored, since its recruitment, for a period of 12 weeks.

13. Timetable and expected date of completion The overall duration of the study is estimated at about 6 months, from patient recruitment to the last data recorded by last subject. The aim is to carry out this study from March 2020 onwards.


Eligibility criteria: Inclusion Criteria:

1. Male or female subject age ≥ 18 years.
2. The subject has no symptoms in last week of COVID-19 infection such as:

   * Body temperature ≤ 37, 1 ºC.
   * Normal lung and breath functions.
3. The subject belongs to the Hospital de La Princesa workforce.

Exclusion Criteria:

1. People with any symptom suspicious of COVID-19 infection.

Primary outcomes:
measure: COVID-19 App-based platform
timeFrame: 6 months
Secondary outcomes:
measure: COVID-19 infection
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
Study officials:
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Joan Soriano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soriano JB, Fernandez E, de Astorza A, Perez de Llano LA, Fernandez-Villar A, Carnicer-Pont D, Alcazar-Navarrete B, Garcia A, Morales A, Lobo M, Maroto M, Ferreras E, Soriano C, Del Rio-Bermudez C, Vega-Piris L, Basagana X, Muncunill J, Cosio BG, Lumbreras S, Catalina C, Alzaga JM, Gomez Quilon D, Valdivia CA, de Lara C, Ancochea J. Hospital Epidemics Tracker (HEpiTracker): Description and pilot study of a mobile app to track COVID-19 in hospital workers. JMIR Public Health Surveill. 2020 Sep 21;6(3):e21653. doi: 10.2196/21653.
Clinical trial NCT04110600: Efficacy of Coffee Versus Peppermint Oil Intake in Promoting GIT Motility After Cesarean Section
Official title: Efficacy of Coffee Versus Peppermint Oil Intake in Promoting GIT Motility After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Motility and Defecation Conditions
Keywords: Bowel movements
Cesarean section
Oral hydration
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 2
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is a comparison between coffee effect versus peppermint oil in promoting GIT motility after cesarean section

Detailed description: This study includes 600 patients who underwent cesarean delivery under spinal anaethesia subdivided into two groups each contain 300 patients Group 1 will have 100 ml of coffee after 2,4 and 6 hours Group 2 will have 100 me of pepper mint oil After 2,4 and 6 hours

Then outcomes will be assessed as per time frame

Eligibility criteria: Inclusion Criteria:

* willingness to participate.
* uncomplicated pregnancy.
* uncomplicated cesarean section.
* under regional anesthesia
* BMI\<30kg/m.
* level of hemoglobin is 10g/dl or more

Exclusion Criteria:

* medical disorders in the form of HTN,DM and hepatic disorders and bleeding disorders
* intra operative bowel or bladder injury during the cesarean section
* intra operative severe bleeding
* chronic gastrointestinal problems like chronic constipation ,peptic ulcer ,esophagitis ,hiatus hernia and IBS
* sever intestinal adhesions
* Respiratory problems and infection that require medication intervention
* operation more than 90 minutes

Primary outcomes:
measure: Regain of GIT motility after cesarean section by auscultation of intestinal sound
timeFrame: First 12 hours after cs
Secondary outcomes:
measure: Sense of nausea
timeFrame: First 24 hours after cs
measure: Sense of vomiting
timeFrame: First 24 hours after cs
measure: First passage of flatus
timeFrame: First 24 hours after cs
measure: First defection
timeFrame: First 24 hours after cs
measure: Effect on abdominal distention
timeFrame: First 24 hours after cs
measure: Need of medication to enhance motility of GIT
timeFrame: First 24 hours after cs
measure: Length of hospital stay after surgery
timeFrame: First 24 hours after cs
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams maternity hospital
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Nermine Elghareb, Lecturer
role: STUDY_DIRECTOR
affiliation: Ain Shams Maternity Hospital
name: Ahmed Tharwat, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05565300: Effects of Cycling Dual-task in Parkinson's Disease.
Official title: Effects of a Forced Cycling Program With Cognitive Stimulation on Symptomatology, Physical Condition, and Cognition in People Diagnosed With Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Vigo
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Taking into account the process of functional and cognitive evolution that patients with Parkinson's disease experience throughout the evolution of the pathology, the objective of this study is to evaluate the effect of a dual-task program combining cognitive tasks and forced cycling on the functional and cognitive capacity of these patients.


Eligibility criteria: Inclusion Criteria:

* Parkinson disease
* Hoehn and Yahr 1 and 2

Exclusion Criteria:

* Hoehn and Yahr \>2

Primary outcomes:
measure: Timed Up and Go
timeFrame: Change from Baseline Timed Up and Go at 12 weeks
measure: Sit to Stand test
timeFrame: Change from Baseline Sit to Stand Test at 12 weeks
measure: Movement Disorder Society - Unified Parkinson's Disease Rating Scale
timeFrame: Change from Baseline Unified Parkinson's Disease Rating Scale at 12 weeks (0-159, better lower values)
measure: Parkinson's Disease Questionnaire - 39
timeFrame: Change from Baseline Parkinson's Disease Questionnaire - 39 at 12 weeks (0-100, better lower values)
Secondary outcomes:
measure: Trail Making Test A & B
timeFrame: Change from Baseline Trail Making Test A & B at 12 weeks
measure: Stroop test
timeFrame: Change from Baseline Stroop Test at 12 weeks
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: University of Vigo
Study officials:
References:
Clinical trial NCT03108300: Use of Propranolol Hydrochloride in the Treatment of Metastatic STS
Official title: The Use of Propranolol Hydrochloride Combined With Anthracyclin Based Chemotherapy in the Treatment of Metastatic Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malignant Soft Tissue Sarcoma
Keywords: efficacy
propranolol hydrochloride
sts
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fifty patients with pathological proof of malignant soft tissue sarcoma will receive Anthracyclin based chemotherapy combined with propranolol 40 mg twice daily.

* The primary end point : To assess Progression Free Survival (PFS)
* The secondary end points : To assess Overall Survival (OS) and Toxicity Profile


Eligibility criteria: Inclusion Criteria:

1. Histologic or cytologic diagnosis of malignant soft tissue sarcoma.
2. ECOG less than or equal to 2 .
3. Measurable disease according to the requirements of modified RECIST criteria.
4. Age ≥ 19 years .
5. Estimated life expectancy of at least 12 weeks .
6. Adequate bone marrow reserve (white blood cells \[WBC\] ≥ 3.5 × 109 /L, neutrophils ≥ 1.5 × 109 /L, platelets ≥ 100 × 109 /L, and hemoglobin ≥ 9.0 gm/dL).

Exclusion Criteria:

1. Inadequate liver function (bilirubin \> 1.5 times upper normal limit \[UNL\] and alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \> 3.0 UNL or up to 5.0 UNL in the presence of hepatic metastases).
2. Inadequate renal function (creatinine \> 1.25 times UNL, creatinine clearance \< 50mL/min).
3. Serious concomitant systemic disorder incompatible with the study.
4. Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence).
5. Pregnancy

Primary outcomes:
measure: Progression Free Survival
timeFrame: an average of 1 year
Secondary outcomes:
measure: Overall Survival
timeFrame: an average of 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05197400: Comparison of the Effect of Supine and Prone Position on the Ultrasonographic Airway Measurements
Official title: A Prospective Randomized Comparison of the Effect of Supine and Prone Position on the Ultrasonographic Upper Airway Measurements and Postoperative Critical Respiratory Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Edema
Obstructive Sleep Apnea
Respiratory Complication
Keywords: airway edema
obstructive sleep apnea
respiratory complications
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this study is to compare the preoperative and postoperative ultrasonographic measurements of patients undergoing in the prone position and the change in upper airway edema.

The secondary aim of the study is to investigate the relationship between OSAS risk levels determined by the STOP-BANG score in the preoperative period of the patients participating in the study, and airway ultrasound measurements and postoperative critical respiratory events in the preoperative and postoperative period.


Eligibility criteria: Inclusion Criteria:1-American Society of Anesthesiologists Physical Status Classification (ASA) I-II-III-IV risk group who will undergo Percutaneous Nephrolithotomy surgery

Exclusion Criteria:

1. prone position contraindications
2. history of maxillofacial deformity, tumor or trauma,
3. difficult airway history
4. decompensated cardiac, respiratory, hepatic, renal diseases
5. cervical spine fracture
6. Patients refusal -

Primary outcomes:
measure: Preoperative Tongue thickness
timeFrame: Baseline, preoperative
measure: postoperative Tongue thickness1
timeFrame: postextubation
measure: postoperative Tongue thickness2
timeFrame: postoperative 2. hour]
measure: preoperative Tongue volume
timeFrame: Baseline, preoperative
measure: postoperative Tongue volume1
timeFrame: postextubation
measure: postoperative Tongue volume2
timeFrame: postoperative 2. hour
measure: Preoperative Lateral parapharyngeal wall thickness
timeFrame: Baseline, preoperative
measure: postoperative Lateral parapharyngeal wall thickness1
timeFrame: postextubation
measure: postoperative Lateral parapharyngeal wall thickness2
timeFrame: postoperative 2. hour
measure: Critical respiratory events
timeFrame: Within postoperative 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital Bilkent
Study officials:
affiliation: ankara ch bilkent
name: ışıl karabeyoğlu, md
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara CH bilkent
name: betül güven aytaç
role: STUDY_CHAIR
References:
Clinical trial NCT06597175: Evaluating Investigational Medical Device for Breast Tumor Diagnosis Using Diffusion Optical Spectroscopy
Official title: A Multi-center, Open-label, Single Arm, Prospective Pivotal Medical Device Clinical Trial to Evaluate Efficacy and Safety of Study Device (ORIGO) That Provides Numerical Data by Measuring the Composition Within Breast Tissue Using Diffusion Optical Spectroscopy Imaging Technology to Assist in the Differential Diagnosis of Breast Tumors in Patients With Breast Lesions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Breast Tumor
Mammary Carcinoma, Human
Lead sponsor: Olive Healthcare
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Device: ORIGO
Primary purpose: DIAGNOSTIC

Brief summary: This is a multicenter, pivotal clinical trial to evaluate the safety and efficacy of a diagnostic device used to assist in the differentiation of breast tumors in patients with breast lesions detected by ultrasound alone or by both ultrasound and mammography.


Eligibility criteria: Inclusion Criteria:

* Female aged 19 years or older
* ACR BI-RADS Category 3-5 (5th edition, 2023 update)

Exclusion Criteria:

* Pregnant, potentially pregnant, or currently breastfeeding
* Calcifications detected on mammography but do not have corresponding lesions identified on ultrasound
* Biopsy performed on the same breast within 7 days prior to the date of informed consent
* Significant trauma or scarring at the measurement site, or those suffering from mastitis.
* Breast implants, electronic medical devices such as pacemakers, or with a space left in the breast cavity due to implant removal
* History of phototoxic reactions or light sensitivity

Primary outcomes:
measure: Concordance
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Yongin-si
country: Korea, Republic of
facility: Yongin Severance Hospital
Study officials:
References:
Clinical trial NCT04513275: Research on Accurate Prediction of Long-term Medication Use for Schizophrenia Based on Cognitive Function
Official title: Research on Accurate Prediction of Long-term Medication Use for Schizophrenia Based on Cognitive Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-medicine Intervention
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Schizophrenia patients with first episode and disease duration of 5, 10, 20, and 30 years

Brief summary: Chinese version of the cognitive function test of schizophrenia (MCCB) . To explore a predictive model for long-term medication use in patients based on cognitive function


Eligibility criteria: Inclusion Criteria:

* Schizophrenia patients with first episode and disease duration of 5, 10, 20, and 30 years _Meet the diagnostic criteria for schizophrenia in ICD-10

Exclusion Criteria:

* Other people with mental illness

Primary outcomes:
measure: Score of MATRICS Consensus Cognitive Battery
timeFrame: 1 day (only one time)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03491475: Echocardiography During Ajmaline Test
Official title: Dynamicity of Echocardiography During Ajmaline Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brugada Syndrome
Keywords: Ajmaline test
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for Ajmaline test, either because of symptoms or in the context of familial screening.

Brief summary: In this study the investigators analyse echocardiographic images before and during Ajmaline test. The purpose is to know if any echocardiographic modifications are present during either negative or positive Ajmaline testing.

Detailed description: The diagnosis of Brugada Syndrome is made when a type 1 pattern is present on the electrocardiogram (ECG), either spontaneously or after administration of a sodium channel blocker. For pathofysiological understanding, the investigators will analyse echocardiography images before and during the administration of Ajmaline. Comparing echocardiographies before and during negative Ajmaline test, will allow the investigators to indentify the effect of Ajmaline administration on cardiac function. The comparison between images of negative and positive Ajmaline tests will expose differences related to the occurence of a type 1 ECG.

Eligibility criteria: Inclusion Criteria:

* \>17 years old
* clinical indication for Ajmaline test

Exclusion Criteria:

* History of right ventricular outflow tract ablation

Primary outcomes:
measure: Speckle tracking strain measurement
timeFrame: 1 day at the time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Esther Scheirlynck, MD
role: PRINCIPAL_INVESTIGATOR
References: