louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00894335: Anesthesia Management of Retroperitoneal Adrenalectomies
Official title: Anesthesiological Management of Hemodynamics and Gas Exchange for Retroperitoneal Adrenalectomies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adrenal Tumors
Keywords: retroperitoneoscopic adrenalectomy
intraoperative arterial-alveolar Carbon dioxide Difference
Lead sponsor: Kliniken Essen-Mitte
Sponsor class: OTHER
First posted: 2009-05-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with adrenal tumors scheduled for retroperitoneal adrenalectomies

Brief summary: This study is a prospective, perioperative evaluation of hemodynamic and respiratory parameters in patients undergoing retroperitoneoscopic adrenalectomies.

Detailed description: Due to their underlying disease, patients with adrenal tumors are prone to episodes of hyper- and hypotension. Furthermore, excessive hypercarbia and an increased arterial-alveolar CO2 difference can be seen during these operations.

Eligibility criteria: Inclusion Criteria:

* Patients with an adrenal tumor

Exclusion Criteria:

* Age below 18 years

Primary outcomes:
measure: Arterial-alveolar Carbon dioxide Difference
timeFrame: 3 years
Secondary outcomes:
measure: Perioperative maximal mean arterial pressure
timeFrame: 3 Years
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Clinics Essen-Mitte
Study officials:
affiliation: Clinics Essen-Mitte
name: Harald Groeben, Prof, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walz MK, Alesina PF, Wenger FA, Deligiannis A, Szuczik E, Petersenn S, Ommer A, Groeben H, Peitgen K, Janssen OE, Philipp T, Neumann HP, Schmid KW, Mann K. Posterior retroperitoneoscopic adrenalectomy--results of 560 procedures in 520 patients. Surgery. 2006 Dec;140(6):943-8; discussion 948-50. doi: 10.1016/j.surg.2006.07.039.
Clinical trial NCT01853735: Enteral Feeding in the Post-Injury Open Abdomen
Official title: Enteral Nutrition in the Open Abdomen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma to the Abdomen
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Maximum age (years): 98
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients requiring an open abdomen following trauma will be prospectively followed.

Brief summary: The purpose of this study is to determine if Enteral Feeding (EN) in patients with a traumatic bowel injury requiring an open abdomen impacts outcomes. Patients who receive EN will be compared to those who remain nil-per-os (NPO). Additionally, an internal study control will be performed by analyzing concurrent injured patients requiring an open abdomen who did not have a bowel injury.

Specific aims:

Hypothesis 1: EN in patients with a traumatic bowel injury requiring an open abdomen improves fascial closure rate compared to patients who remain NPO.

Hypothesis 2: EN in patients with a traumatic bowel injury requiring an open abdomen reduces infectious complications compared to patients who remain NPO.

Hypothesis 3: EN in patients with a traumatic bowel injury requiring an open abdomen have a lower mortality rate compared to patients who remain NPO.

Detailed description: Fascial closure is determine by the primary physician and should be recorded in the operative record. This record will be accessed to determine if this variable is accomplished. Additionally, any dehiscence complication will be recorded (which would impact the long-term fascial closure rate). Infectious complications (abscess, pneumonia, etc) will be adjudicated by the primary clinician and any record of this in the patient chart will be recorded.

Eligibility criteria: Inclusion Criteria:

* All patients with a post-injury open abdomen

Exclusion Criteria:

* Patients to be excluded from analysis include deaths within 24 hours, identification of injury \> 24 hours, and those transferred from an outside hospital \> 24 hours following initial injury.

Primary outcomes:
measure: fascial closure rate
timeFrame: participants will be followed for their hospital stay, which is on average expected to be 1 month
Secondary outcomes:
measure: mortality
timeFrame: participants will be followed for their hospital stay, which is on average expected to be 1 month
Other outcomes:
measure: infectious complications
timeFrame: participants will be followed for their hospital stay, which is on average expected to be 1 month
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health and Hospital Authority
name: Clay Cothren Burlew, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00995735: IMTN Study- International Prospective Multicenter Trial on Clinical NOTES
Official title: IMTN Study- International Prospective Multicenter Trial on Clinical NOTES
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Surgery
Natural Orifice Surgery
Keywords: NOTES
Natural Orifice Translumenal Endoscopic surgery
Cholecystectomy
Appendectomy
Endoscopy
Laparoscopy
Minimally invasive surgery
clinical trials
Lead sponsor: IMTN NOTES Research Group
Sponsor class: OTHER
First posted: 2009-10-15
Enrollment: 1000
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: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to Natural Orifice Surgery with local IRB aproval for human trials.

Brief summary: Objectives: Since 2007, natural orifice surgery evolved from theory and animal research to clinical applications, but is still limited in the literature to small casuistic reports. A preliminary prospective evaluation of postoperative results of the early casuistic of Natural orifice Surgery for many indications may show advantages and disadvantages of the methods. The IMTN Multicenter Trial for Clinical NOTES was and early results are described.


Eligibility criteria: Inclusion Criteria:

* Patients submitted to elective surgery

Exclusion Criteria:

* emergency surgery High ASA risk patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Municipal Lourenco Jorge
state: RJ
Study officials:
affiliation: Brazilian College of Surgeons CBC
name: Ricardo Zorron
role: PRINCIPAL_INVESTIGATOR
affiliation: Indian Society of Laparoscopic Surgery
name: Chisunnami Palanivelu
role: STUDY_DIRECTOR
affiliation: Society of Brazilian Digestive Endoscopy SOBED
name: Manuel Galvao
role: STUDY_DIRECTOR
affiliation: Brazilian College of Surgeons CBC
name: Almino Ramos
role: STUDY_DIRECTOR
References:
citation: Zorron R, Maggioni LC, Pombo L, Oliveira AL, Carvalho GL, Filgueiras M. NOTES transvaginal cholecystectomy: preliminary clinical application. Surg Endosc. 2008 Feb;22(2):542-7. doi: 10.1007/s00464-007-9646-5. Epub 2007 Nov 20.
Clinical trial NCT03430635: Role of Choline PET/CT in Predicting Survival in Patients With Hepatocellular Carcinoma
Official title: What is the Prognostic Value of ¹¹C-choline PET/CT in Patients Undergoing Hepatectomy for Hepatocellular Carcinoma?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Humanitas Clinical and Research Center
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by HCC candidate to surgical resection that were preoperatively staged with ¹¹C-choline PET/CT.

Brief summary: ¹¹C-choline positron emission tomography/computed tomography (PET/CT) has been used in patients with some types of solid cancers, but few data are available in patients undergoing hepatectomy for hepatocellular carcinoma (HCC). The aim of this study was to analyze the prognostic value of metabolic imaging data by using ¹¹C-choline PET/CT in patients with HCC before hepatectomy.

Detailed description: Our prospectively maintained liver unit database was queried for patients with HCC preoperatively staged with ¹¹C-choline PET/CT. This metabolic imaging modality was performed in addition to standard abdominal CT or magnetic resonance imaging. Several PET/CT parameters were recorded and analyzed. Univariate and multivariate analyses were performed to identify whether those PET/CT parameters could be predictors of overall survival (OS) and disease-free survival (DFS) of HCC patients.

Eligibility criteria: Inclusion Criteria:

* Any patient with HCC candidate to surgical resection preoperatively staged with ¹¹C-choline PET/CT

Exclusion Criteria:

* R2 resection;
* Intraoperative use of RFA/MWI
* Postoperative death (90-days)

Primary outcomes:
measure: Identification of PET/CT parameters that can be predictors of survival
timeFrame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first assessed up to 72 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lanza E, Donadon M, Felisaz P, Mimmo A, Chiti A, Torzilli G, Balzarini L, Lopci E. Refining the management of patients with hepatocellular carcinoma integrating 11C-choline PET/CT scan into the multidisciplinary team discussion. Nucl Med Commun. 2017 Oct;38(10):826-836. doi: 10.1097/MNM.0000000000000719.
citation: Lopci E, Torzilli G, Poretti D, de Neto LJ, Donadon M, Rimassa L, Lanza E, Sabongi JG, Ceriani R, Personeni N, Palmisano A, Pedicini V, Comito T, Scorsetti M, Chiti A. Diagnostic accuracy of (1)(1)C-choline PET/CT in comparison with CT and/or MRI in patients with hepatocellular carcinoma. Eur J Nucl Med Mol Imaging. 2015 Aug;42(9):1399-407. doi: 10.1007/s00259-015-3079-5. Epub 2015 May 12.
Clinical trial NCT05821335: Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis
Official title: The Development and Investigation of Effectiveness of Leap Motion Based Gamefication Exercises in Hand Rehabilitation of the Individuals With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatology
Scleroderma, Systemic
Video Games
Physiotherapy
Rehabilitation
Hand Rheumatism
Keywords: Scleroderma, Systemic
Hand therapy
Therapy, Computer-Assisted
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis

Detailed description: The aim of this project is to develop Leap Motion Sensor-assisted rehabilitation games that can be easily applied in hand rehabilitation in individuals with SSc, motivating, directing to the right exercise, providing therapeutic evaluation and feedback during the game, and comparing the effectiveness of these rehabilitation games with traditional rehabilitation applications.

Eligibility criteria: Inclusion Criteria:

* Having the ability to adapt to exercises
* Not having any diagnosed cardiac or orthopedic disease that may prevent the application of assessment methods

Exclusion Criteria:

* Having a diagnosis of juvenile-onset SSc
* Having a history of neurological disease or trauma that will affect hand functions
* Receiving another treatment, such as intra-articular injection, surgery, that may affect hand rehabilitation in the last 6 months
* Having systemic involvement that may affect the treatment process or activities of daily living

Primary outcomes:
measure: modified Hand Mobility in Scleroderma (mHAMIS)
timeFrame: change from baseline at 5 weeks
Secondary outcomes:
measure: Finger Joint Range of Motion
timeFrame: change from baseline at 5 weeks
measure: Grip Strength
timeFrame: change from baseline at 5 weeks
measure: Skin Hardness
timeFrame: change from baseline at 5 weeks
measure: Purdue Pegboard Test
timeFrame: change from baseline at 5 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: TUGBA CIVI KARAASLAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tarakci E, Arman N, Tarakci D, Kasapcopur O. Leap Motion Controller-based training for upper extremity rehabilitation in children and adolescents with physical disabilities: A randomized controlled trial. J Hand Ther. 2020 Apr-Jun;33(2):220-228.e1. doi: 10.1016/j.jht.2019.03.012. Epub 2019 Apr 19.
citation: Murphy SL, Poole JL, Chen YT, Lescoat A, Khanna D. Rehabilitation Interventions in Systemic Sclerosis: A Systematic Review and Future Directions. Arthritis Care Res (Hoboken). 2022 Jan;74(1):59-69. doi: 10.1002/acr.24737. Epub 2021 Dec 22.
Clinical trial NCT02388035: Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis
Official title: Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spontaneous Bacterial Peritonitis
Keywords: profiles changes
microorganisms
cefotaxime
SBP
Egyptian
effective antibiotics
Lead sponsor: Nasser Institute For Research and Treatment
Sponsor class: OTHER_GOV
First posted: 2015-03-13
Enrollment: 254
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spontaneous bacterial peritonitis (SBP) is a serious complication in cirrhotic patients, and the changes in the microbiological characteristics reported in the last years are impacting the choice of antibiotic used in the treatment. Cefotaxime has been the most extensively studied antibiotic for this infection. It is considered to be one of the first choice antibiotics because of low toxicity and excellent efficacy. Treatment of SBP by intravenous cefotaxime should be administered for a minimum 5 days. Antibiotic-resistant microorganisms have been increasingly reported especially to cefotaxime and its effect on the clinical outcome in treating SBP.


Eligibility criteria: Inclusion Criteria:

* patients with liver cirrhosis and ascites and clinical findings suspicious of ascitic fluid infection

Exclusion Criteria:

* Patients were excluded if they received antibiotics ten days prior to the hospital admission or there is evidence of secondary bacterial peritonitis, tuberculous peritonitis, malignant ascites or ascites due to other causes e.g. cardiac or renal diseases

Primary outcomes:
measure: Organisms detected with their antibiotics sensitivity
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nasser institute
state: Shubra
Study officials:
References:
Clinical trial NCT03369535: Metabonomics to Investigate Effects of Healthy Diets on Blood Pressure: the OmniHeart Study
Official title: Urinary Metabolic Phenotyping of Diet-cardiovascular Disease Risk Associations: the OmniHeart Feeding Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
Lead sponsor: University of Kent
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 158
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the urinary metabolomes on individuals undergone three different healthy diets--a carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.

Detailed description: BACKGROUND:

This study based on the OmniHeart dietary intervention study, a randomized, three period cross-over feeding study that compared the effects on blood pressure and plasma lipids of three DASH-like diets: a carbohydrate-rich (CARB) diet pattern, a rich in protein (PROT) and a rich in unsaturated (MUFA) fat, predominantly monounsaturated fat diet (see full details of OmniHeart dietary intervention https://clinicaltrials.gov/ct2/show/record/NCT00051350).

This metabonomic study aims to evaluate the feasibility of identifying individuals showing variation in clinical response to three different healthy diets, with the purpose of reducing cardiovascular disease (CVD) risk, using proton nuclear magnetic resonance (NMR) based metabolic phenotyping approach.

Eligibility criteria: Inclusion Criteria:

* with pre-hypertension (systolic BP of 120 to 139 mmHg and/or diastolic BP of 80 to 89 mmHg) or stage 1 hypertension (systolic BP of 140 to 159 mm Hg and/or diastolic BP of 90 to 99 mm Hg) and without diabetes or prior CVD

Exclusion Criteria:

* CVD or diabetes

Primary outcomes:
measure: Systolic blood pressure (SBP)
timeFrame: post 6 weeks intervention
Secondary outcomes:
measure: Diastolic blood pressure (DBP)
timeFrame: post 6 weeks intervention
measure: low density lipoprotein cholesterol (LDL)
timeFrame: post 6 weeks intervention
measure: high density lipoprotein cholesterol (HDL)
timeFrame: post 6 weeks intervention
measure: triglycerides (TG)
timeFrame: post 6 weeks intervention
measure: total cholesterol
timeFrame: post 6 weeks intervention
Other outcomes:
Locations:
Study officials:
References:
citation: Loo RL, Zou X, Appel LJ, Nicholson JK, Holmes E. Characterization of metabolic responses to healthy diets and association with blood pressure: application to the Optimal Macronutrient Intake Trial for Heart Health (OmniHeart), a randomized controlled study. Am J Clin Nutr. 2018 Mar 1;107(3):323-334. doi: 10.1093/ajcn/nqx072.
Clinical trial NCT00935935: Study of Bone Disease in Older HIV-infected Adults
Official title: A Pilot Study on the Immunopathogenesis of Bone Disease in Older HIV-infected Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteopenia
Osteoporosis
HIV Infection
Aging
HIV Infections
Keywords: Treatment experienced
Lead sponsor: Ruth M. Rothstein CORE Center
Sponsor class: OTHER
Collaborators: name: Rush University Medical Center
name: Merck Sharp & Dohme LLC
First posted: 2009-07-09
Enrollment: 101
Sex: ALL
Minimum age (years): 50
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: 100 HIV-infected adults, age 50 years or older, on HAART with undetectable viral loads, who are randomly sampled from 6 strata defined by ethnicity (Black:White:Hispanic; 2:1:1) and sex (male:female; 1:1).

100 HIV+ adults, age ≥ 50 yr (50 ♂, 50 ♀; 50 AA, 25 W, 25 H).

Brief summary: This study will look to see if there are changes in the blood cells that are associated with bone disease and sort out effects that are due to the HIV virus itself, the medications and see if faster aging occurs in the cells of HIV infected persons. Bone disease will be measured by a special X-ray called a DEXA scan. A DEXA scan is used by doctors to see if someone has normal bone mass for their age or if there is thinning of the bones.

The purposes of this study are:

* to learn how common bone disease is in HIV infected patients over the age of 50 years that receive their care at the CORE Center
* to see what are the common causes of bone disease in older HIV infected persons
* to see if there are differences in blood cells and levels of cytokines in patients who do or do not have bone disease, as this may help researchers determine the cause of bone disease.


Eligibility criteria: Inclusion Criteria:

* HIV-1 infection documented by ELISA and confirmed by western blot
* Treatment with antiretroviral drugs for at least 12 months
* Age 50-70 years
* CD4 count \> 350 cells/mm3 for at least 6 months
* HIV-RNA undetectable (\< 75 copies/ml for at least 6 months)

Exclusion Criteria:

* Known bone disease (primary or metastatic malignancy, osteomalacia)
* Treatment for bone disease (bisphosphonates, calcitonin, strontium, sodium fluoride, synthetic PTH, or high-dose vitamin D \[\> 800 IU daily\]).

Primary outcomes:
measure: Assess the associations between outcome (bone density) and predictors (markers of inflammation and immune activation) using continuous variables
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ruth M Rothstein CORE Center
state: Illinois
Study officials:
affiliation: Ruth M. Rothstein CORE Center
name: Oluwatoyin Adeyemi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00857558: A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
Official title: A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes, Type 2
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 350
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes patients with HbA1c above 7.0% and below 10%
* Patients who are capable of giving informed consent
* Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner

Exclusion Criteria:

* Patients with type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (IGT) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus
* Patients with a medical history of diabetes coma
* Patients with poorly-controlled hypertension
* Patients with heart failure
* Patients with a complication of active hepatitis or hepatic cirrhosis
* Patients undergoing treatment of glomeruler diseases other than diabetic nephropathy
* Patients with a history or complication of malignant tumor

Primary outcomes:
measure: changes in HbA1C from baseline
timeFrame: 2w, 4w, 8w, 12w, 16w
Secondary outcomes:
measure: values and changes in HbA1c form baseline
timeFrame: 2w, 4w, 8w, 12w, 16w
measure: values and changes in fasting blood glucose (FSB) from baseline
timeFrame: 2w, 4w, 8w, 12w, 16w
measure: adverse event
timeFrame: at any time
Other outcomes:
Locations:
city: Chubu regin
country: Japan
city: Chugoku region
country: Japan
city: Hokkaido region
country: Japan
city: Kanto region
country: Japan
city: Kinki region
country: Japan
city: Kyushu region
country: Japan
city: Shikoku region
country: Japan
city: Tohoku region
country: Japan
Study officials:
affiliation: OPC-J
name: Katsuhisa Saito
role: STUDY_DIRECTOR
References: