louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00599144: Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy
Official title: Effectiveness for Postoperative Pain After Laparoscopic Cholecystectomy of 0,5% Bupivacaine-Soaked Tabotamp Placed in the Gallbladder Bed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Cholecystectomy
Lead sponsor: Santa Maria alla Gruccia Hospital
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy on postoperative pain of the positioning of a 0,5% bupivacaine soaked-tabotamp in gallbladder bed after videolaparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years old, ASA 1 and 2
* Gallbladder adenomatous polyposis and cholelithiasis with no byochemical, clinical and instrumental evidence of acute cholecystitis at the moment of surgery.

Exclusion Criteria:

* Age\<18 years old
* Pregnancy
* Previous major surgery of the supramesocholic compartment
* Acute cholecystitis
* Choledocolitiasis
* Acute pancreatitis at the moment of surgery
* Laparotomic conversion during surgery

Primary outcomes:
measure: Pain at 6 and 24 hours after surgery measured using the Visual Analogue Scale [VAS] [score 0 to 10, 0 = no pain, 10 = unbearable pain],
timeFrame: 6 and 24 hours after surgery
Secondary outcomes:
measure: Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting.
timeFrame: 6 and 24 hours
Other outcomes:
Locations:
city: Montevarchi
country: Italy
facility: Ospedale santa maria alla gruccia
state: Ar
Study officials:
affiliation: Ospedale Santa maria alla gruccia
name: Marco Scatizzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verma GR, Lyngdoh TS, Kaman L, Bala I. Placement of 0.5% bupivacaine-soaked Surgicel in the gallbladder bed is effective for pain after laparoscopic cholecystectomy. Surg Endosc. 2006 Oct;20(10):1560-4. doi: 10.1007/s00464-005-0284-5. Epub 2006 Aug 1.
citation: Feroci F, Kroning KC, Moraldi L, Borrelli A, Ottaviano A, De Prizio M, Scatizzi M. [A new effective method to reduce pain after laparoscopic cholecystectomy]. G Chir. 2010 Oct;31(10):423-8. Italian.
citation: Feroci F, Kroning KC, Scatizzi M. Effectiveness for pain after laparoscopic cholecystectomy of 0.5% bupivacaine-soaked Tabotamp placed in the gallbladder bed: a prospective, randomized, clinical trial. Surg Endosc. 2009 Oct;23(10):2214-20. doi: 10.1007/s00464-008-0301-6. Epub 2009 Jan 28.
Clinical trial NCT05752344: Interstitial Cystitis: Monitoring of the Psychic State and Counseling Intervention in the COVID-19 Era
Official title: Interstitial Cystitis: Monitoring of the Psychic State and Counseling Intervention in the COVID-19 Era
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystitis, Interstitial
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this observational study is made up of all patients belonging to the Interstitial Cystitis pathway of the Gemelli University Hospital Foundation - IRCCS, who will accept to be subjected to remote monitoring and diagnostic investigation as per the proposed scheme.

Brief summary: The target population of this observational study is made up of all patients belonging to the Interstitial Cystitis pathway of the Gemelli University Hospital Foundation - IRCCS, who have accepted to be subjected to remote monitoring and diagnostic investigation. The aim of the study is the evaluation of some outcome parameters at the time of enrollment (T0), and at the end (T1) of subjects affected by Intersitial Cystitis who have carried out a monitoring of the dimensions of the psychic sphere concerning: depression, trait anxiety, state anxiety , well-being, self-efficacy, resilience.The objective is also to evaluate the presence of evolutionary and maturational trends in the mental set-up of the people who participated in the individual counseling intervention.


Eligibility criteria: Inclusion Criteria:

* Recruited subjects have a diagnosis of Interstitial Cystitis and are 18 years of age or older.

Exclusion Criteria:

* Previous or current intellectual disability in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5.
* Patients who are unable to express consent and who do not have a caregiver who can give it for them.

Primary outcomes:
measure: Gastrointestinal Symptom Rating Scale (GSCG)
timeFrame: 12 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 months
Secondary outcomes:
measure: Psychological General Well-Being Index (PGWBI)
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
state: Roma
Study officials:
References:
Clinical trial NCT06034444: Better tArgetting, Better Outcomes for Frail ELderly Patients
Official title: Better tArgetting, Better Outcomes for Frail ELderly Patients: A Quality Improvement Initiative in Long-term Care Facilities Using interRAI Long-term Care Assessment in Quebec
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Residents in Longterm Care Facilities
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Canadian Frailty Network
First posted: 2023-09-13
Enrollment: 5692
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: Residents in a long-term care facility (nursing home)

Brief summary: The acronym for this proposal, BABEL, refers to the fact that a common "language" - the interRAI risk-stratification and decision-making tool - will be used in this project, allowing several measures of care quality in long-term care facilities to be compared with those in other provinces for the first time. The impact of the use of this assessment system and associated care planning protocols will also be investigated using usual practice as the point of reference.


Eligibility criteria: Inclusion Criteria:

* All nursing home residents in a particular unit where standardized evaluations are being introduced (for example, all residents in a particular floor or wing of the longterm care facility)

Exclusion Criteria:

* Residents who are admitted to a nursing home unit for less than 1 week.

Primary outcomes:
measure: Change in depression prevalence
timeFrame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
measure: Change in prevalence of potentially inappropriate antipsychotic use
timeFrame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
measure: Change in falls prevalence
timeFrame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
measure: Change in prevalence of pain
timeFrame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
measure: Change in the prevalence of physical restraints use
timeFrame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
Secondary outcomes:
measure: Change in prevalence of pressure ulcers
timeFrame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
Other outcomes:
measure: Change in other interRAI LTCF quality indicators
timeFrame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
Locations:
city: Montréal
country: Canada
facility: Donald Berman Maimonides
state: Quebec
Study officials:
References:
Clinical trial NCT01133444: Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting Condition
Official title: Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg and Merck & Co., Propecia Under Fasting Condition.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence,Finasteride,Crossover
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2010-05-28
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Merck \& Co. (Propecia®)

1 mg finasteride tablets under fasting conditions following administration of a 3 mg dose.

Detailed description: Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 2 alternates. A total of 24 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. Single oral 3 mg doses were separated by a washout period of 7 days.

Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

History or presence of significant:

• cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

In addition, history or presence of:

* alcoholism or drug abuse within the past year;
* hypersensitivity or idiosyncratic reaction to finasteride or any other 5-a reductase inhibitor.

Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study.

Subjects who, through completion of the study, would have donated in excess of:

* 500 mL of blood in 14 days, or
* 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
* 1000 mL of blood in 90 days,
* 1250 mL of blood in 120 days,
* 1500 mL of blood in 180 days,
* 2000 mL of blood in 270 days,
* 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.

Primary outcomes:
measure: Bioequivalence based on Cmax and AUC parameters
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cohen street, saint-laurent, montreal (quebec)
country: Canada
facility: MDS Pharma Services
Study officials:
affiliation: MDS Pharma Services
name: Gaetano Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01232244: Oxyntomodulin, Mechanisms of Action in Relation to Appetite, Food Intake, Gastric Emptying and Energy Expenditure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incretin Action
Obesity
Keywords: Incretin hormones
Glucagon
Satiety
Hunger
Energy expenditure
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young males

Brief summary: Tiny molecules (hormones) are released from the bowels and other organs to the bloodstream in response to meals in order to orchestrate the metabolism. Oxyntomodulin, GLP-1 and glucagon are all known to regulate parameters such as appetite, food intake and induce weight loss.

Therefore we want to investigate mechanistic relations between the three hormones.


Eligibility criteria: Inclusion Criteria:

* Normal fasting plasma glucose
* Normal glucose tolerance
* Normal haemoglobin levels
* Informed content

Exclusion Criteria:

* Diabetes
* Pre diabetes (impaired glucose tolerance or impaired fasting glucose)
* 1st degree relatives with diabetes
* Obesity (BMI \> 30)
* Inflammatory bowels disease
* Bowels surgery
* Nephropathy
* Liver disease
* Medication which cannot be on hold for 24h

Primary outcomes:
measure: Gastric emptying
timeFrame: 4 h
measure: Satiety
timeFrame: 4 h
measure: Hunger
timeFrame: 4 h
measure: basal energy expenditure
timeFrame: 2 x 30min
Secondary outcomes:
measure: GLP-1
timeFrame: 4 h
measure: Oxyntomodulin
timeFrame: 4 h
measure: Glucagon
timeFrame: 4 h
measure: GIP
timeFrame: 4 h
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte University Hospital
Study officials:
affiliation: Gentofte University Hospital, University of Copenhagen
name: Jonatan I Bagger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bagger JI, Holst JJ, Hartmann B, Andersen B, Knop FK, Vilsboll T. Effect of Oxyntomodulin, Glucagon, GLP-1, and Combined Glucagon +GLP-1 Infusion on Food Intake, Appetite, and Resting Energy Expenditure. J Clin Endocrinol Metab. 2015 Dec;100(12):4541-52. doi: 10.1210/jc.2015-2335. Epub 2015 Oct 7.
Clinical trial NCT06967844: Effects of Simultaneous Versus Sequential Motor-cognitive Task Training on Balance and Coordination Among Elderly Individuals
Official title: Effects of Simultaneous Versus Sequential Motor-cognitive Task Training on Balance and Coordination Among Elderly Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance
Cognitive Functions
Keywords: balance
coordination
dual-task performance
Simultaneous Motor-cognitive task training
Sequential Motor-cognitive task training
cognition
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized control trial will be done on elderly individuals in Community Homes of Rawalpindi/Islamabad. Motor-cognitive impairments impact the life of elderly individuals. The purpose of the study is to determine the effects of simultaneous versus sequential motor-cognitive task training on balance, coordination, dual task performance and cognitive functions using the Berg Balance Scale, Mini Mental State Examination, Fall Efficacy Scale and time up and go test, The Simultaneous Motor-cognitive task traning includes activities like walking while counting, balancing on one foot while naming or solving puzzles, and ball toss with recall for forty minutes. The sequential motor-cognitive task training includes standing on one foot, heel-to-toe walk, and leg swings for 20 minutes; and after 20 min rest time followed by memory games and problem-solving tasks for 20 minutes. 12 sessions for 6 weeks will be given.


Eligibility criteria: Inclusion Criteria:

* age 65 years or older
* MMSE scoring 24 or higher
* BBS scoring 41-56

Exclusion Criteria:

* cardio, neurological, musculoskeletal, and psychiatric problems.

Primary outcomes:
measure: Balance
timeFrame: 6 weeks
measure: Dual task performance
timeFrame: 6 weeks
measure: Cognition
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Thrapy
Study officials:
References:
Clinical trial NCT03216044: Chronic Pain After Childbirth - Caesarean Section Compared to Vaginal Delivery and the Impact of Pre-existing Pain
Official title: Incidence and Predictors of Chronic Pain After Vaginal Childbirth and C-section - a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: childbirth
caesarean delivery
vaginal delivery
chronic pain
painful sexual intercourse
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 355
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women living in the city of Tuebingen and Stuttgart or the area surrounding

Brief summary: There is no doubt, that surgery is very often the beginning of a chronic pain disorder. C-section is a worldwide performed operation with increasing trend in the developed countries .This prospective cohort study evaluated the incidence of persistent pain after childbirth in respect of the pain status before childbirth and the modus of delivery.

Detailed description: There are different variables that may influence the occurrence of chronic pain after childbirth. One of these could be c- section , pain status before childbirth or other psychological factors like fear of birth, irrational cognitive beliefs about delivery and perinatal complications. The pain status (intensity and location), demographic data, anesthesiological details and data about the circumstances of birth are evaluated by structured interview during pregnancy and 3 month and 12 moth after childbirth. The pregnant women received an individual code for access to the survey on the website of the study. The recruitment takes placed in doctors or midwifes office and by advertising. The commuting area was the city of Tuebingen (Germany). Women who feel uncomfortable with the media based survey supplied a written form. Study population is planned with 500 participants. The Institute for Clinical Epidemiology and Applied Biometry support the statistical analysis.

Eligibility criteria: Inclusion Criteria:

* age of consent
* must be german-speaking

Exclusion Criteria:

- no written consent

Primary outcomes:
measure: Incidence of new chronic pain disorder after vaginal delivery and after c-section
timeFrame: 3 months after delivery
measure: Incidence of new chronic pain disorder after vaginal delivery and after c-section
timeFrame: 12 month after delivery
Secondary outcomes:
measure: Quality of Life (SF 12) after 12 months of delivery
timeFrame: 12 months after delivery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02625844: Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents in Hemodialysis Centers in Croatia
Official title: Croatian Time and Motion Survey for Anaemia Management With Erythropoietin Stimulating Agents in Haemodialysis Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Anemia of Chronic Kidney Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-12-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care personnel providing care for patients with renal anemia on monopegylated epoetin beta or other erythropoiesis stimulating agents (ESAs)

Brief summary: This study is to document the time spent by health care personnel on anemia-related tasks, including preparation, distribution and administration of monopegylated epoetin beta (Mircera) or other erythropoiesis-stimulating agents (ESAs) in patients with end stage renal disease in hemodialysis centers in Croatia. The total average time will be determined for the same number of patients on monopegylated epoetin beta and patients on other ESAs. In addition, qualitative information will be obtained on changes in practice patterns that may have occurred with the introduction of monopegylated epoetin beta.


Eligibility criteria: Inclusion Criteria:

- Treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adult patients

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Uncontrolled hypertension

Primary outcomes:
measure: Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs)
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bjelovar
country: Croatia
city: Split
country: Croatia
city: Zadar
country: Croatia
city: Zagreb
country: Croatia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01422044: Risk Prediction in Aortic Stenosis
Official title: Risk Prediction in Aortic Stenosis by Cardiac Autonomic Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: aortic stenosis
autonomic function
Lead sponsor: Thebiosignals.com
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 423
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 with at least moderate aortic stenosis

Brief summary: The purpose of this study is to test the prognostic value of autonomic markers in patients with aortic stenosis.

Detailed description: Autonomic function will be assessed by presence of severe autonomic failure (defined by combination of abnormal heart rate turbulence and deceleration capacity).

Autonomic function will also be assessed by respiration and repolarization abnormalities.

Eligibility criteria: Inclusion Criteria:

* Aortic valve area ≤1.5 qcm or mean aortic gradient ≥25mmHg

Exclusion Criteria:

* life expectancy \<1 year due to non-cardiac causes

Primary outcomes:
measure: Total mortality
timeFrame: 2 years
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 2 years
measure: Combination of cardiovascular mortality and cardiac adverse events
timeFrame: 2 years
measure: Correlation of presence of autonomic dysfunction with severity of aortic stenosis
timeFrame: at time of cardiac catheterization, which will be performed at an expected average of 3 days after hospital admission
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Medizinische Klinik III
Study officials:
References:
citation: Zuern CS, Eick C, Rizas KD, Stoleriu C, Barthel P, Scherer C, Muller KA, Gawaz M, Bauer A. Severe autonomic failure in moderate to severe aortic stenosis: prevalence and association with hemodynamics and biomarkers. Clin Res Cardiol. 2012 Jul;101(7):565-72. doi: 10.1007/s00392-012-0427-3. Epub 2012 Feb 24.