louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00337766: Desmopressin in Cardiac Surgery
Official title: Efficacy of Desmopressin (1-deamin0-8-D-arginine-vasopressin) in Reducing Active Microvascular Bleeding After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage
Keywords: Blood Loss
Postoperative Blood loss
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2006-06-16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing cardiac surgery could develop excessive perioperative bleeding requiring transfusions of blood products.

Desmopressin (DDAVP), already used for patients with von Willebrand syndrome, could reduce bleeding and transfusion requirements in these patients when administered ev (0.3 mg/kg) in 20-30 minutes postoperatively.


Eligibility criteria: Inclusion Criteria:

* undergoing cardiac surgery
* excessive bleeding

Exclusion Criteria:

* age\<18 y
* not signing written consent

Primary outcomes:
measure: Reduce transfusions
Secondary outcomes:
measure: Reduced bleeding
measure: Reduce time on mechanical ventilation
measure: Reduced ICU and Hospital stay
measure: Reduced mortality
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Istituto Ospedaliero Fondazione Poliambulanza
city: Milano
country: Italy
facility: Istituto Policlinico S.Donato
city: Milan
country: Italy
facility: Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
Study officials:
affiliation: Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia.
name: Giovanni Landoni, MD
role: STUDY_DIRECTOR
affiliation: Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia.
name: Giuseppe Crescenzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crescenzi G, Landoni G, Biondi-Zoccai G, Pappalardo F, Nuzzi M, Bignami E, Fochi O, Maj G, Calabro MG, Ranucci M, Zangrillo A. Desmopressin reduces transfusion needs after surgery: a meta-analysis of randomized clinical trials. Anesthesiology. 2008 Dec;109(6):1063-76. doi: 10.1097/ALN.0b013e31818db18b.
Clinical trial NCT01506466: Weight Variation During Chemotherapy in Breast Cancer Patients
Official title: Weight Variation and Mechanisms Involved, During Chemotherapy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: chemotherapy
metabolism
weight
body composition
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2012-01-10
Enrollment: 52
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied.

Thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.


Eligibility criteria: Inclusion Criteria:

* menopausal women
* breast cancer
* patients requiring chemotherapy treatment
* WHO performance status 0-2

Exclusion Criteria:

* diabetics
* patients with metastases
* other cancer

Primary outcomes:
measure: Change from baseline in body composition
timeFrame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
Secondary outcomes:
measure: Change from baseline in energy balance
timeFrame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
measure: Change from baseline in muscle strength
timeFrame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
measure: Change from baseline in biological factors (hormonal, inflammatory, lipid, growth factors)
timeFrame: within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
Study officials:
affiliation: Centre Jean Perrin
name: Xavier DURANDO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05739266: Pulmonary Function and Qi Deficiency Predicted by Acoustic Analysis
Official title: Prediction of Pulmonary Function and Qi Deficiency Based on the Acoustic Analysis Before and After Step Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Qi-Xu; Qi Deficiency
Pulmonary Function; COPD
Keywords: Qi-Xu; Qi deficiency
Pulmonary Function; COPD
Step test; heart recovery rate
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students and staffs of China Medical University, Taiwan

Brief summary: Acoustic analysis is a method of clinically non-invasive, low-cost, remote-operation, and can avoid direct face-to-face contact.

It has been proved by many researches in recent years that it has a high diagnostic rate in predicting diseases. Lung function is closely related to human vocalization and has the potential and need for sound analysis. From literature review, it can be inferred that the Qi deficiency constitution in TCM is related to the strength of heart and lung function.The purpose of this study is to investigate the correlation between cardiopulmonary function and Qi deficiency, and to predict the correlation between the data by computer algorithm and artificial intelligence. Furthermore, the artificial intelligence (AI) self-correction ability can be combined with sound analysis to simulate a sound analysis system that can predict cardiopulmonary function and degree of qi deficiency only through sound information.

Research motivation and questions:

1. Is the sound characteristic of an individual related to individual's qi deficiency and cardiopulmonary function?
2. Can lung function and qi deficiency be measured by sound analysis?
3. To understand the correlation between Qi deficiency and cardiopulmonary endurance index.
4. Is there any difference in sound characteristics before and after step test and does it help predicting cardiopulmonary function?


Eligibility criteria: Inclusion Criteria:

* Age: over 20 years old.
* Agreed and signed Informed Consent Form.

Exclusion Criteria:

* Known heart diseases, acute severe respiratory infection, severe arthritis or other orthopedic disabilities, severe hypertension, or pregnant.

Primary outcomes:
measure: FVC<80%
timeFrame: 10 mins
measure: FVC>80%
timeFrame: 10 mins
measure: Qi deficient
timeFrame: 10 mins
measure: step test: heart rate recovery
timeFrame: 15 mins
measure: Voice record
timeFrame: 15 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: No. 2, Yude Road, North District
state: Taichung City
Study officials:
References:
Clinical trial NCT00617565: Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes
Official title: A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficacy and Safety Profile of Biphasic Insulin Aspart 30 (BIAsp 30) and Biphasic Human Insulin 30/70 (BHI 30/70) in Chinese Type 1 and 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control.


Eligibility criteria: Inclusion Criteria:

* Type 1 or 2 diabetes for at least 3 months
* Stabilised on current treatment with premixed human insulin for at least 4 weeks
* Body mass index (BMI) between 18-40 kg/m2
* HbA1c below 13.0%
* Able and willing to perform self-blood glucose monitoring

Exclusion Criteria:

* The receipt of any investigational drug within the last three months prior to this trial
* Has a history of drug abuse or alcohol dependence within the last 5 years
* Active proliferative retinopathy requiring laser or surgical intervention within the last year
* Recurrent major hypoglycaemia as judged by the Investigator
* Known or suspected allergy to trial product or related product

Primary outcomes:
measure: 2-hr postprandial plasma glucose (PPPG) excursion
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: HbA1c
measure: Fasting plasma glucose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01595165: Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy
Official title: Effect of Subcostal Transversus Abdominis Plane Block on Early Postoperative Pain in Laparoscopic Cholecystectomy: Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Postoperative Pain
Abdominal Muscles
Nerve Block
Keywords: laparoscopic cholecystectomy
ultrasound
transversus abdominis plane block
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transversus abdominis plane (TAP) block has gained popularity for the control of postoperative pain in various surgeries. Three studies showed inconsistent result on pain control after TAP block in laparoscopic cholecystectomy. The TAP technique used in these studies was classic ultrasound guided TAP block. Besides periumbilical incision, sub-xiphoid incision is usually made during laparoscopic cholecystectomy. As typical posterior TAP rarely extend above T8, the investigators undergo subcostal TAP block for this type of surgery. The investigators are going to investigate the effect of subcostal TAP on early postoperative pain after laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Age 20-65 patients scheduled elective laparoscopic cholecystectomy

Exclusion Criteria:

* Patient refusal
* Allergy to ropivacaine
* Coagulopathy
* Morbid obesity (BMI\>35 kg/m2)
* Previous abdominal surgery.

Primary outcomes:
measure: Numerical Rating Scale (NRS) 15 min after entering recovery room
timeFrame: 15 min after entering recovery room
Secondary outcomes:
measure: Fentanyl consumption at recovery room
timeFrame: Up to 3 hours until discharge from recovery room
measure: Recovery room stay
timeFrame: Up to 3 hours from entering recovery room to discharge
measure: Incidence of postoperative nausea and vomiting (PONV)
timeFrame: Up to 3 hours during recovery room stay
measure: NRS at 4h, 24h, and 48 h after surgery
timeFrame: 4h, 24h, and 48 h after surgery
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Sang-Hyun Kim
state: Gyeonggi
Study officials:
affiliation: Soonchunhyang University Hospital
name: Sang-Hyun Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06388265: Emotional and Oral Characteristics of Patients That Attend a Dental Consultation for the Extraction of Third Molars
Official title: Emotional and Oral Characteristics of Patients That Attend a Dental Consultation for the Extraction of Third Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety and Fear
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Analyze the level of anxiety, hemodynamic parameters, oral status, and satisfaction among patients undergoing third molar extraction, we will assess those who attend the Master of Oral Medicine, Surgery, and Implantology program at the University of Barcelona.


Eligibility criteria: Inclusion Criteria:

* Individuals 18 years old or older, from both genders that wished to voluntarily participate in the study and that required the extraction of third molars.

Exclusion Criteria:

* Systemic diseases (ASA III or IV) that contraindicate the performance of the surgical procedure
* Pregnant women
* Individuals that did not understand and/or could not respond the given questionnaire.
* Patients that required the extraction of a different tooth than a third molar or that required the extraction of more than two third molars in the same surgical time.
* Patients who had undergone extraction of a third molar in the twelve months prior to the current visit.
* Patients taking antidepressant medication or anxiolytic medication

Primary outcomes:
measure: Changes in STAI-S
timeFrame: Through study completion, an average of 5 weeks
measure: Changes in MDAS
timeFrame: up to 3 weeks
Secondary outcomes:
measure: Changes in blood pressure
timeFrame: Through study completion, an average of 5 weeks
measure: Changes in Heart rate
timeFrame: Through study completion, an average of 5 weeks
measure: Changes in Oxygen saturation
timeFrame: Through study completion, an average of 5 weeks
measure: Patient Satisfaction of procedure
timeFrame: 1 week after the procedure
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Odontològic Universitat de Barcelona
state: Barcelona
Study officials:
affiliation: University of Barcelona
name: José López-López, PhD
role: STUDY_DIRECTOR
affiliation: University of Barcelona
name: Mayra Schemel Suarez, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01691066: Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
Official title: Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study aims to investigate the utility of Pivotal Response Treatment (PRT), a behaviorally derived intervention, to improve the quality and frequency of communication and social engagement of toddlers with siblings who have an autism spectrum disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social interaction between 12 and 15 months of age.


Eligibility criteria: Inclusion Criteria:

* toddlers, age 12 - 15 months, who have an older sibling with ASD
* delays of at least 1.5 standard deviations in communication (receptive/expressive language) based on developmental testing
* scores that exceed the ASD cutoff on standardized measures of social-communicative behavior

Exclusion Criteria:

* physical or neurological disorder (e.g., seizures, cerebral palsy)

Primary outcomes:
measure: Feasibility of a novel behavioral treatment
timeFrame: 24 months
measure: Acceptability of a novel behavioral treatment
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Katarzyna Chawarska, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00249366: Treatment of Alcohol Withdrawal in Hospital Patients
Official title: Acute Drug Withdrawal in a General Medical Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcohol Withdrawal Syndrome
Keywords: Alcohol withdrawal
Symptom-triggered therapy
Fixed-schedule therapy
CIWA-Ar
Lorazepam (drug)
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-11-07
Enrollment: 183
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test how tolerable and effective lorazepam is when used to treat alcohol withdrawal in hospital patients at risk for alcohol withdrawal.

Detailed description: Studies show that symptom-triggered dosing is best for treatment of alcohol withdrawal in patients on chemical dependence units without other illness. On general medical hospital wards, withdrawal may be affected by comorbid medical illness. A clinical trial was undertaken to determine whether there is a difference between symptom-triggered (ST) and fixed-schedule (FS) dosing of lorazepam in patients hospitalized on general medical wards at a University medical center. Subjects were assessed by their nurses with the Revised Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scale. Subjects in the ST arm received lorazepam doses based on CIWA-Ar score. Subjects in the FS arm received scheduled lorazepam with tapering over 4 days.

Eligibility criteria: Inclusion Criteria:

* Alcohol dependence (based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)
* Daily alcohol use for at least seven consecutive days with the last use no more than 72 hours prior to enrollment
* Patients on the General Internal Medicine service

Exclusion Criteria:

* Unable to give informed consent
* Chronically maintained on prescription sedative-hypnotics

Primary outcomes:
measure: Withdrawal Assessment Scores
timeFrame: participants were followed for the duration of hospital stay, the median length of stay was 3 days
measure: Total Dose of Lorazepam
timeFrame: participants were followed for the duration of hospital stay, the median length of stay was 3 days
measure: Protocol Errors
timeFrame: participants were followed for the duration of hospital stay, the median length of stay was 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University Medical Center
name: Michael F. Weaver, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weaver MF, Hoffman HJ, Johnson RE, Mauck K. Alcohol withdrawal pharmacotherapy for inpatients with medical comorbidity. J Addict Dis. 2006;25(2):17-24. doi: 10.1300/j069v25n02_03.
Clinical trial NCT06585566: Alveolar Cleft Reconstruction With Cortical-Shells
Official title: Evaluation of Secondary Alveolar Cleft Reconstruction With Labial and Palatal Retromolar Cortical-Shells (A Case Series Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alveolar Cleft
Keywords: Bone graft
Cortical- shells
Radiographic Density
Horizontal bone gain
Vertical bone loss
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 7
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main goal of the secondary alveolar bone grafting (SABG) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements.

The study evaluates the outcomes of a ( SABG) technique that utilizes the retromolar cortical shell technique to reconstruct the alveolar clefts.


Eligibility criteria: Inclusion Criteria:

1. Patients of both sexes with an age range of (eight to fifteen years), with unilateral maxillary alveolar cleft.
2. good oral hygiene and general good health

Exclusion Criteria:

1. The evidence of clinical or radiographic signs of local maxillary pathosis or palatal fistulae.
2. Those patients with bilateral alveolar clefts, cleft-associated syndromes, and those with a systemic disease that would affect either bone harvest or graft healing.
3. A history of previous failed alveolar cleft reconstruction.

Primary outcomes:
measure: Horizontal bone width
timeFrame: 6 months consolidation period
Secondary outcomes:
measure: Vertical bone level
timeFrame: 6 months consolidation period
measure: Bone density
timeFrame: 6 months consolidation period
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Amr Gibaly
city: Cairo
country: Egypt
facility: Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Modern University for Technology & Information.
Study officials:
References: