louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04900233: Effect of Covid-19 Pandemic in Non Covid-19 Patients at the Emergency Surgical Department
Official title: Effect of Covid-19 Pandemic in Non Covid-19 Patients at the Emergency Surgical Department, During the Severe Restriction Phase of Lockdown in Buenos Aires. A Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Emergencies
Appendicitis
Surgical Procedure, Unspecified
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 651
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -patients over 18 years

Brief summary: Introduction Most countries imposed mandatory lockdowns that were rapidly lifted, however Argentina holds the record for one of the longest quarantines in the world. General surgery emergency conditions and trauma cases still require immediate evaluation and timely resolution. The primary objective of this study was to analyze the variations in the consults, surgical outcomes and severity of disease in admissions at our department of general surgery and to study the consequences of the lockdown effect in our community.

Materials and methods An observational, ambispective study was carried out on a prospective cohort of patients who consulted with on-call surgical pathology and required hospitalization in the period from March 13th, 2020 until July 31, 2020 (PG) were included, analyzed and compared with the same period of 2019 (CG).

Detailed description: Participation in the study does not represent any additional risk for the included participants since participation in the protocol does not include any experimental intervention and the medical care and treatment of all participants that require it will be carried out according to the current guidelines. The protocol does not contemplate any procedure or study additional to the usual care of the patient.

Eligibility criteria: Inclusion Criteria:

* all non-Covid-19 patients over 18 years who consulted at the emergency surgical department of Hospital Italiano de Buenos Aires and required hospitalization in the period from March 13th, 2020 until July 31, 2020 (Pandemic Group-PG) and compared with the same period of 2019 (Control Group-CG).

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of patients admitted to the emergency department
timeFrame: 2019-2020
measure: Clinical presentation of the patients at the time of admission
timeFrame: 2019-2020
measure: Has the COVID-19 pandemic made a significant change in the hospital admissions?
timeFrame: 2019-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
Study officials:
References:
Clinical trial NCT04776733: Prepackaged Nutritional Formulations Versus Restricted Diet for Bowel Preparation
Official title: Comparing the Efficacy and Tolerability of a Prepackaged Semisolid Nutritional Formulations With a Restricted Diet for Colonoscopy Preparation: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bowel Preparation
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: In order to analyze the effectiveness and patient tolerance of the two bowel preparation regimens, the investigators will compare prepackaged semisolid nutritional formulations and restricted diet. The aim was to demonstrate that prepackaged semisolid nutritional formulations is not inferior in overall quality of intestinal preparation to restricted diet in subjects undergoing colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients age between 18-75 years old requiring colonoscopy and willing to participate in this study.

Exclusion Criteria:

1. Patients with constipation;
2. Patients with congestive heart failure;
3. Patients with a history of kidney disease;
4. Patients with a history of poor intestinal preparation;
5. Pregnant / lactating women;
6. Patients without informed consent;
7. Allergic or intolerant to any research drug;
8. Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon;
9. Patients with a history of inflammatory bowel disease;
10. History of colorectal resection；
11. Patients with diabetes.

Primary outcomes:
measure: Quality of Bowel Preparation
timeFrame: 1 Day of colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT00372333: IDEA-033 Open Label Study
Official title: A Multiple-Dose, Open-Label Safety, Compliance, and Usage Evaluation Study of Epicutaneously Applied IDEA-033 in Joint / Musculoskeletal Pain or Soft Tissue Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Joint Pain
Musculoskeletal Pain
Stiffness
Soft Tissue Inflammation in Designated Target Area(s)
Keywords: musculoskeletal pain; soft tissue inflammation; IDEA-033
Lead sponsor: IDEA AG
Sponsor class: INDUSTRY
First posted: 2006-09-06
Enrollment: 491
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main aim of the study is to evaluate safety, efficacy, compliance, and usage of epicutaneously applied IDEA-033 in joint / musculoskeletal pain or soft tissue inflammation.

Detailed description: Multi-centre, one arm, multiple dose, open-label, at home usage study. Adult volunteers experiencing joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation will be screened for study participation.

Eligibility criteria: Inclusion Criteria:

* at least 18 years or older
* agree to refrain from chronic usage of NSAIDs or any other analgesics or anti-inflammatory drugs other than those provided during the course of the study or documented sporadic concomitant analgesics
* joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation in designated target area(s) that are appropriate for self-treatment with a topical analgesic or where availability of a second person can be guaranteed in case self-treatment is not possible
* healthy skin in the target area(s)

Exclusion Criteria:

* known hypersensitivity to IDEA-033 or other NSAIDs
* history of coagulation disorders
* history of peptic ulcers or gastric intolerance with NSAIDs
* urinary tract infection
* clinically significant renal, hepatic, or gastric disease
* acute or chronic coexisting illness qualifying for exclusion according to clinical judgement of the investigator
* clinical laboratory values outside normal range deemed clinically significant by the investigator
* Narcotics-containing products within 7 days of administering IMP
* Malignancy within the past 2 years

Primary outcomes:
measure: description of AE profile
measure: changes in laboratory values
measure: IDEA-033 plasma levels
measure: visual assessment of skin at target area(s)
measure: physical exam
measure: vital signs
Secondary outcomes:
measure: evaluation of efficacy by real time feedback
Other outcomes:
Locations:
city: Gräfelfing
country: Germany
facility: X-pert med GmbH / Ilka Rother
state: Bavaria
Study officials:
affiliation: X-pert-med GmbH Munich
name: Ilka Rother
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01464333: Special Investigation (Long-term Investigation) in Patients With Crohn's Disease
Official title: Humira® for Subcutaneous Injection Protocol for Special Investigation (Long-term Treatment for Crohn's Disease Patients)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-11-03
Enrollment: 511
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: Those who are receiving Humira in accordance with its indications for treatment and dosage regimens.

Brief summary: This study of Humira will be conducted to obtain information on the safety (especially profile of malignant tumors and serious infections) and effectiveness in patients with Crohn's disease who are receiving Humira for a long period of time.


Eligibility criteria: Inclusion Criteria:

* Patients with Crohn's disease indicated for Humira treatment with the recommended dosage regimen
* Patients with no past- or present malignant tumors
* Patients who are not currently receiving Humira

Exclusion Criteria:

* None.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From first dose of Humira up to 3 years
Secondary outcomes:
measure: Change in Crohn's Disease Activity Index (CDAI) Score Over Time
timeFrame: From first dose of Humira up to 3 years
measure: Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time
timeFrame: From first dose of Humira up to 3 years
measure: Change in WPAI: CD Presenteeism Over Time
timeFrame: From first dose of Humira up to 3 years
measure: Change in WPAI: CD Overall Work Impairment Over Time
timeFrame: From first dose of Humira up to 3 years
measure: Change in WPAI: CD Activity Impairment Over Time
timeFrame: From first dose of Humira up to 3 years
measure: Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)
timeFrame: From first dose of Humira up to 3 years
measure: Change in C-Reactive Protein (CRP) Levels Over Time
timeFrame: From first dose of Humira up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00454233: A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects
Official title: A Randomized, Double Blind, Placebo and Active Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability and Potential Efficacy of a 12-Week Treatment With YM543 in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Mellitus Type 2
YM543
Treatment
Safety
efficacy
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-03-30
Enrollment: 97
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: The purpose of this study is to investigate the safety of YM543 in type 2 Diabetes Mellitus patients and to investigate whether this study drug is effective in these patients


Eligibility criteria: Inclusion Criteria:

* Treatment-naive subjects diagnosed with T2DM
* Stable diet and exercise program for at least 6 weeks
* Inadequate glycemic control indicated by HbA1c and FPG level at Visit 1

Exclusion Criteria:

* Any known complication of T2DM indicating a late disease state, clinical manifestations of macro- and/or micro vascular disorders
* Use of insulin or oral blood glucose lowering drugs in the last 3 months

Primary outcomes:
measure: Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination)
timeFrame: 3 Months
Secondary outcomes:
measure: Efficacy and pharmacodynamics (change in HbA1c and fasting plasma glucose; change in urinary glucose excretion; plasma levels of YM543; C-peptide, insulin, fructosamine, non-esterified fatty acids, triglyceride, cholesterol-panel)
timeFrame: 3 Months
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
city: Moscow
country: Russian Federation
facility: 4 Sites
city: N. Novgorod
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Samara
country: Russian Federation
city: St. Petersburg
country: Russian Federation
facility: 10 Sites
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT06960733: Comparison Between Winged Versus Traditional Plastic Stents for Biliary Drainage
Official title: Comparative Efficacy of Winged Versus Traditional Plastic Stents for Biliary Drainage in Benign and Malignant Obstructions: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Obstruction
Bile Duct Stones
Biliary Tract Cancer
Keywords: ERCP
Biliary obstruction
biliary stenting
plastic stent
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was randomized, controlled, blinded trial with a two-arm parallel-group design to directly compare the therapeutic outcomes of winged versus conventional stents in patients with benign or malignant biliopancreatic conditions requiring ERCP and subsequent insertion or replacement of plastic stents.

Detailed description: Procedure The study was structured as a randomized, controlled trial using a two-arm parallel group design to compare different therapies (winged stent vs. conventional stent). Randomization was carried out in a 1:1 ratio using block randomization. Upon stent exchange, participants were switched to the alternate treatment group. Each subject was intended to receive both forms of therapy over the course of the treatment periods in a crossover design, with only the sequence of therapies being determined randomly (Figure 1).

The procedures were conducted using standard techniques. No additional steps, biopsies, or similar procedures were required. For the ERCPs carried out in the Endoscopy Department of the University Hospital Leipzig, Fujifilm video duodenoscopes were utilized

Data On the procedure date, we gathered essential baseline and procedural information including demographic data (age and gender), previous stent interventions, diagnostic imaging and laboratory results, specifics of the stent used (type, diameter, and length), the effectiveness of the stent insertion, and any associated complications.

Beyond standard care, follow-up was conducted at intervals of one week, one month, and two months post-intervention, utilizing a methodical questionnaire to monitor clinical progress and evaluate for any stent-related dysfunction."

Eligibility criteria: Inclusion Criteria:

* Biliopancreatic disorder requiring plaxtic biliary stent therapy
* written informed consent

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Live Expectancy of less than one month
* Biliary drainage by metal stent or external drainage.

Primary outcomes:
measure: Dysfunction
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig Medical Center, Department of Gastroenterology
state: Saxonia
Study officials:
affiliation: University of Leipzig Medical Center
name: Albrecht Hoffmeister, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT02083133: Insulin Dosing in Diabetic Patients With End Stage Renal Disease (ESRD) or Hemodialysis
Official title: Dosing Strategies in Diabetic Patients With End Stage Renal Disease (ESRD) or Hemodialysis (DOSE-HD Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Hypoglycemia
Renal Dysfunction
Insulin Dosing
Keywords: Diabetes
Renal Failure
Dialysis
End Stage Renal Disease
Hypoglycemia
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
First posted: 2014-03-11
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In patient hospitalized greater than or equal to three days, diabetic with CKD 3-5 or on dialysis on insulin therapy

Brief summary: The purpose of this study is to assess whether the current recommendation for a 50% dose reduction in insulin for diabetic patients with a creatinine clearance (CrCl) ≤15 mL/min or on hemodialysis results in an increased number of hypoglycemic episodes.


Eligibility criteria: Inclusion Criteria:

* Inpatient men and women 18 years of age and older with a diagnosis of type 2 diabetes mellitus (T2DM) with CrCl ≥60, 16-59 or ≤15 milliliters/minute.

Exclusion Criteria:

* Patients less than 18 years of age, pregnant patients

Primary outcomes:
measure: Hypoglycemia
timeFrame: Last 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H Stroger Hospital of Cook County
state: Illinois
Study officials:
affiliation: Cook County Hospital
name: Pete Antonopoulos, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00194233: Serum and Peritoneal Fluid Bank for Endometriosis Markers
Official title: Serum and Peritoneal Fluid Bank for Assessment of Markers of Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: Endometriosis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing Laparoscopy at HUP

Brief summary: The purpose of this study is to investigate differences in protein expression profiles of blood and peritoneal fluid samples obtained from patients who do, and those who do not, have endometriosis seen during laparoscopic surgery. These profiles may include both known and novel markers for diagnosing endometriosis.


Eligibility criteria: Inclusion Criteria:

* Undergoing laparoscopic surgery for one of the following indications:

  1. infertility
  2. pain
  3. tubal sterilization
* For cases, visualization of endometriosis
* For controls, absence of endometriosis

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Reproductive Research Unit
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kurt T Barnhart, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05307133: Oxytocin and Sleeve Gastrectomy
Official title: Oxytocin Serum Variation Following Laparoscopic Sleeve Gastrectomy in Morbidly Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Morbid obesity has become a common condition and there is no effective drug that is able to induce a sustained weight loss. Currently bariatric surgery remains the only effective means that is able to lead to long term sustained weight loss. Oxytocin is a hormone secreted by the hypophysis that regulates negatively the adipogenesis and positively the osteogenesis. Oxytocin also regulates appetite and its role in weight loss in humans has not been investigated so far. The aim of the present study is to elucidate whether plasma levels of oxytocin and sleeve gastrectomy induced weight loss are correlated in pre-menopausal morbidly obese women.


Eligibility criteria: Inclusion Criteria:

* Women aged 18-65, pre-menopausal,
* able to read and understand the written informed consent,
* with a BMI \> 40 or 35
* with at least one obesity linked comorbidity among blood hypertension,
* type 2 diabetes,
* sleep apnea syndrome,
* invalidating arthritis,
* indication for sleeve gastrectomy
* accepted by the multidisciplinary committee and the CPAM (local health care system agency),
* affiliation to the Fre,nch health care system,
* signature of the informed consent.

Exclusion Criteria:

* Post-menopausal women,
* any other bariatric procedure that sleeve gastrectomy, history of any other bariatric procedure,
* pregnancy,
* age less than 18 years under, under guardianship
* Patients undergoing any other procedure that the planned sleeve gastrectomy or undergoing a second bariatric procedure for a complications during the 6 months follow-up.

Primary outcomes:
measure: plasma leves of oxytocin
timeFrame: 6 months
Secondary outcomes:
measure: sleeve gastrectomy
timeFrame: 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes-maritimes
Study officials:
affiliation: CHU de Nice, Service de Chirurgie
name: Iannelli Antonio, PhD
role: PRINCIPAL_INVESTIGATOR
References: