louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02363231: Maximal Inspiratory Pressure at Extubation: Relationship With Mortality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 124
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: Critically ill patient under invasive mechanical ventilation

Brief summary: The process of weaning from mechanical ventilation was decided after clinical judgment and weaning predictive index. Nevertheless, indexes predicting weaning outcome like Maximal Inspiratory Pressure (MIP) are frequently inaccurate. However the long-term involvement of respiratory muscles in critically ill patients has not been established. The objective of this study was to assess the relationship on MIP at extubation on one-year mortality in critically ill patients.


Eligibility criteria: Inclusion Criteria:

* Mechanical ventilation at least at 24 hours

Exclusion Criteria:

* Delirium
* Cognitive dysfunction
* refusal to participate

Primary outcomes:
measure: Mortality
timeFrame: One year after extubation
Secondary outcomes:
measure: Time to mechanical ventilation weaning
timeFrame: During Intensive care unit hospitalization
Other outcomes:
Locations:
city: Montivilliers
country: France
facility: Le Havre, Jacques Monod Hospital
Study officials:
affiliation: Groupe Hospitalier du Havre
name: Clement Medrinal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Combret Y, Prieur G, Hilfiker R, Gravier FE, Smondack P, Contal O, Lamia B, Bonnevie T, Medrinal C. The relationship between maximal expiratory pressure values and critical outcomes in mechanically ventilated patients: a post hoc analysis of an observational study. Ann Intensive Care. 2021 Jan 13;11(1):8. doi: 10.1186/s13613-020-00791-4.
citation: Medrinal C, Prieur G, Combret Y, Quesada AR, Bonnevie T, Gravier FE, Frenoy E, Contal O, Lamia B. Reliability of respiratory pressure measurements in ventilated and non-ventilated patients in ICU: an observational study. Ann Intensive Care. 2018 Jan 30;8(1):14. doi: 10.1186/s13613-018-0362-1.
citation: Medrinal C, Prieur G, Frenoy E, Robledo Quesada A, Poncet A, Bonnevie T, Gravier FE, Lamia B, Contal O. Respiratory weakness after mechanical ventilation is associated with one-year mortality - a prospective study. Crit Care. 2016 Jul 31;20(1):231. doi: 10.1186/s13054-016-1418-y.
Clinical trial NCT00076531: Clinical Trial for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
PSA
Leuprolide
Lead sponsor: Oakwood Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2004-01-27
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Phase III trial using an injectable for treatment of prostate cancer.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Oakwood Laboratories, LLC
name: James A. Page, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02975531: Simulator of Pompage Technique for Physiotherapists
Official title: Simulator of Pompage Technique for Education and Training of Physiotherapists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Contracture
Keywords: Pompage
Lead sponsor: University of Mogi das Cruzes
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Parameterize the Pompage technique with an anatomical model cervical region to simulate specific procedures. Quantify the times, displacements, and facilitate the training of students and professional of physical therapy.

Detailed description: Manual techniques are taught and trained with practical demonstration without technology support to measure them, so they are difficult to reproduce. This difficulty increases in Pompage technique because the student is not able to estimate the displacement on the skin. In this research, to parameterize and train the technique was developed and validated an anatomical model of the cervical region, with silicone and latex rubber. The anatomical model simulates the soft tissues and a plastic resin structure represents the cervical spine bone. An optical sensor was used to measure the displacements performed on simulated skin versus time. The Likert scale was used for assessing the similarity of the anatomical model relative to the size, shape, texture, elasticity and displacement of the skin as well as the curvature of the cervical spine. Five experienced professionals (GP) in the technical performed five series of Pompage technique. With the mean of data collected were determined benchmarks for technical and implemented in a standard guide to train the volunteers. Twenty-six volunteers (GE) with no experience performed the Pompage technique, with the anatomical model following the standard guide. A physical therapist (VE) was selected to evaluate the volunteers (GE) before and after training in the simulator.

Eligibility criteria: Inclusion Criteria:

* no history of cervical trauma (GT and VF)
* Do not have dermatitis in the cervical region (GT and VF)
* recurrent migraines (GT and VF)
* no prior knowledge of Pompage technique (GE).
* minimum 5 years experience of applying the Pompage technique (GP and VE).

Exclusion Criteria:

* report pain in the cervical region (GT and VF)
* irritations in the cervical region (GT and VF)

Primary outcomes:
measure: Displacement of the skin
timeFrame: 5 days
measure: Pressure
timeFrame: 5 days
Secondary outcomes:
measure: Cytometry neck
timeFrame: 1 minute
Other outcomes:
Locations:
Study officials:
affiliation: University of Mogi das Cruzes
name: Annie F. Frère, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06230731: Oxygenation in Vascular Lesions of the Colon
Official title: Oxygenation in Vascular Lesions of the Colon
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vascular Lesion
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this clinical trial is to evaluate oxygenation in the colon in people with acquired vascular abnormalities in the proximal colon.

Detailed description: The etiology of acquired vascular abnormalities of the large bowel (i.e. angiodysplasia, AVM, hemangiomas of the cecum. etc.) are unknown. These lesions typical appear as ectatic, dilated, and tortuous blood vessels within the submucosa and mucosa of the GI tract. In some patients they are the cause of acute large volume bleeding or a slower chronic bleed that manifests as chronic iron deficiency anemia. These lesions are more common in older individuals and those with underlying cardiac, pulmonary, and renal disease. As such, it is hypothesized that these lesions may result from chronic hypoxia. This study aims to evaluate oxygenation of the colon in people with acquired vascular abnormalities in the proximal colon compared to healthy controls.

Eligibility criteria: Inclusion Criteria:

* Undergo standard of care colonoscopy
* People with a history of vascular lesions of the colon
* People with healthy colon
* 18 - 89 years of age

Exclusion Criteria:

* Age \< 18 years
* Age \> 90 years
* People with ulcerations in at ascending colon opposite the ileocecal valve
* Previous colon surgery

Primary outcomes:
measure: Quantitative analysis of colonic oxygen saturation levels
timeFrame: baseline-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Joel Pekow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05065931: Real-world Effectiveness Evaluation of Clinical Decision Support System Based on Artificial Intelligence (AI-CDSS)
Official title: Real-world Effectiveness Evaluation of Clinical Decision Support System Based on Artificial Intelligence (AI-CDSS) on Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Informatics Applications
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 34113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population was the hospitalized patient from December 2016 to February 2019 in 6 clinical departments. The six clinical departments were Otolaryngology, Orthopaedic, Respiratory Medicine, General Surgery, Cardiology and Hematology.

Brief summary: This study intends to explore the accuracy of clinical diagnosis of AI based CDSS system and promotion of clinical work by comparing CDSS before and after the online.

Detailed description: This study intends to explore the accuracy of clinical diagnosis of AI based CDSS system and promotion of clinical work by comparing CDSS before and after the online. The difference of diagnostic accuracy before and after AI-CDSS application will be compared by the before and after design, and the role of AI-CDSS will be explored.

Eligibility criteria: Inclusion Criteria:

* all hospitalized patients in 6 clinical departments, Otolaryngology, Orthopaedic, Respiratory Medicine, General Surgery, Cardiology and Hematology from December 2016 to February 2019.

Exclusion Criteria:

* Missing data for key variables

Primary outcomes:
measure: Accuracy Rate of Recommended Diagnosis by CDSS, up to 12 weeks
timeFrame: When the subject was discharged from the hospital
measure: Patients' hospitalization time (days), up to 24 weeks
timeFrame: When the subject was discharged from the hospital
measure: consistency between admission diagnosis and discharge diagnosis up to 12 weeks
timeFrame: When the subject was discharged from the hospital
Secondary outcomes:
measure: length of confirmed time, up to 6 weeks
timeFrame: When the subject was discharged from the hospital
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Hong Qi, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05246631: Haloperidol and Dexamethasone Towards Postoperative Nausea and Pain in Adult After Laparoscopy
Official title: Haloperidol Compared to Dexamethasone in Lowering Postoperative Nausea and Vomiting and Pain in Adult After Laparoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparoscopy
Postoperative Nausea and Vomiting
Keywords: dexamethasone
haloperidol
nausea
pain
vomiting
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aim to find out the effectiveness of 1 mg intravenous haloperidol compared to 5 mg intravenous dexamethasone to prevent the occurrence of nausea and vomiting also as pain control in adult patients after laparoscopic surgery.

Detailed description: Eighty subjects (n=40 for each group) scheduled for laparoscopic-assisted surgery were enrolled in a randomized double-blind clinical trial. One milligram intravenous haloperidol was given one hour before the end of surgery, while 5 mg intravenous dexamethasone was given right after induction. The occurrence of Postoperative Nausea and Vomiting (PONV) and visual analog scale (VAS) pain score were recorded.

Eligibility criteria: Inclusion Criteria:

* underwent laparoscopic surgery (gynecology, digestive, or urology surgery)
* American Society of Anesthesiologist (ASA) physical status 1-3

Exclusion Criteria:

* psychological or neurological disorders (routine haloperidol consumption)
* history of allergic reaction to dexamethasone or haloperidol
* diabetes mellitus
* did not give the consent

Primary outcomes:
measure: Nausea and Vomiting
timeFrame: Within 24 hours postoperative
Secondary outcomes:
measure: Pain and VAS
timeFrame: 0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours postoperative
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Aldy Heriwardito, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01420731: Back Pain and Male Sexual Disfunction
Official title: Phase 4 Study Back Pain and Male Sexual Disfunction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Marriage, Life Event
Keywords: sexual life, back pain
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 54
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20-45 years old,male patients with active sexual life

Brief summary: Back pain is a common hormonal disorder in men that may affect the phases of male sexual function. The investigators investigated sexual function in male patients with back pain.

A total of 54 men with back pain and 27 age matched voluntary healthy men who served as the as control group were evaluated with a detailed medical and sexual history, including a international erectile function index (IEFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.

Detailed description: A total of 54 men with back pain and 27 age matched voluntary healthy men who served as the as control group were evaluated with a detailed medical and sexual history, including a international erectile function index (IEFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.

Eligibility criteria: Inclusion Criteria:

* Male patient with back pain
* 20 - 45 years old
* Active sexual life

Exclusion Criteria:

* Younger than 20, older than 45 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Beazialem Vakıf University
name: Gökçen Başaranoğlu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05023031: Evaluation of Pharmacokinetic and Safety of NVP-2102 and NVP-2102-R in Healthy Subjects
Official title: A Phase 1 Clinical Trial, Open-label, Randomized Study in Healthy Subjects to Evaluate Pharmacokinetic Characteristics and Safety After Oral Administration of NVP-2102 and NVP-2102-R in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2021-08-26
Enrollment: 53
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics and safety of NVP-2102 and NVP-2102-R.

Detailed description: Evaluate the pharmacokinetics and safety of NVP-2102 compared to NVP-2102-R

Eligibility criteria: Inclusion Criteria:

* Healthy subject, 19 years of age or older
* Subjects who signed informed consent
* Body mass index(BMI) of 18 to 30.0 kg/㎡

Exclusion Criteria:

* Subject who has clinically significant medical history
* Inadequate subject for the clinical trial by the investigator's decision
* Subjects participated in another clinical trial within 6 months prior to the first administration of investigational product

Primary outcomes:
measure: Evaluation of Area under the plasma drug concentration-time curve(AUCt)
timeFrame: 0 ~ 72 hours
measure: Evaluation of Maximum observed plasma concentration(Cmax)
timeFrame: 0 ~ 72 hours
Secondary outcomes:
measure: Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)
timeFrame: 0 ~ 72 hours
measure: Evaluation of AUCt/AUC∞
timeFrame: 0 ~ 72 hours
measure: Evaluation of Time of peak concentration(Tmax)
timeFrame: 0 ~ 72 hours
measure: Evaluation of Terminal phase of Half-life(t1/2)
timeFrame: 0 ~ 72 hours
measure: Evaluation of total clearance of the drug from plasma after oral administration(CL/F)
timeFrame: 0 ~ 72 hours
measure: Evaluation of volume of distribution after non-intravenous administration(Vz/F)
timeFrame: 0 ~ 72 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
state: Nambusunhwan-ro
Study officials:
affiliation: H+ Yangji hospital
name: Jae Woo Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00894231: Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis
Official title: Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perennial Allergic Rhinitis
Lead sponsor: AAADRS Clinical Research Center
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2009-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to noninvasively measure the anti-inflammatory effect of levocetirizine after two weeks of treatment in allergic rhinitis subjects.


Eligibility criteria: Inclusion Criteria:

* ICF signed
* Diagnosis of PAR for 6-12 months greater
* 12 years and older
* Decreased nasal NO values at baseline
* Compliance and ability to perform maneuvers and responsibilities

Exclusion Criteria:

* Oral or systemic steroids for 60 days prior
* Inhaled, nasal, nebulized steroids w/i 4 weeks
* Hospitalization or life threatening asthma
* Use of nasal or oral antihistamines w/i 4 weeks
* Upper or lower airways infection
* Direct cigarette smoke exposure

Primary outcomes:
measure: The change in objective measure of inflammation nasal NO after LC treatment.
timeFrame: two weeks
Secondary outcomes:
measure: The change in nasal eosinophils, QOL and diary scores after LC treatment.
timeFrame: two weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: AAADRS
state: Florida
Study officials:
affiliation: AAADRS Clinical Research Center
name: Miguel J Lanz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02287831: Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease
Official title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection for Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peripheral Arterial Disease
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of umbilical cord blood mesenchymal stem cells with peripheral arterial disease.

Detailed description: The present study is designed to implant UCB-MSC in patients with CLI, which are resulted from peripheral arterial disease,such as thromboangiitis obliterans, atherosclerosis obliterans and diabetic foot, and to evaluate the safety and efficacy of the implantation procedure.

Eligibility criteria: Inclusion Criteria:

1. Age of 18-75 years
2. Patients confirmed diagnosed peripheral vascular disease , ankle-brachial index \< 0.9
3. Poor distal arterial outflow tract
4. Patient had at least 3 months conservative treatment ,which resulted in little or no improvement
5. Poor physical condition can not tolerate surgery
6. Patients are willing to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Renal function damage (over 2 X upper normal range) Liver function damage (over 3 X upper normal range )
2. Severe or acute organ damage
3. Presence of malignancy
4. Pregnancy or lactating patients
5. HIV positive
6. ABI≧0.9
7. A history of severe allergies related cell therapy
8. Conservative treatment \< 3 months
9. Acute limb ischemia
10. Local obvious infection uncontrolled
11. Alcoholics or drug abusers within a year
12. Severe psychiatric disorder.
13. Patients need surgical treatment
14. Above the ankle gangrene
15. Patients with other factors which were considered not to be suitable to participate in the study by the investigators.

Primary outcomes:
measure: To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.
timeFrame: 6 months
Secondary outcomes:
measure: To evaluate effectiveness related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Pingping Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: