louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01632488: Assessment of Small Intestinal Bowel Epithelial Gaps in Irritable Bowel Syndrome
Official title: Assessment of Small Intestinal Bowel Epithelial Gaps in Patients With Irritable Bowel Syndrome by Confocal Laser Endomicroscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Irritable Bowel Syndrome
Inflammatory Bowel Disease
Keywords: Irritable Bowel Syndrome
Inflammatory Bowel Disease
Confocal Laser Endomicroscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2012-07-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department.

Brief summary: The study aims to:

1. Determine whether the density of epithelial gaps in terminal ileum of patients with irritable bowel syndrome (IBS) is different from that in inflammatory bowel disease (IBD) patients and normal controls by confocal laser endomicroscopy (CLE).
2. Evaluate the relationship between the density of epithelial gaps and IBS subtypes, and visceral hypersensitivity.

Detailed description: Epithelial cells lining the gastrointestinal tract serve as a barrier between the gut lumen and the body. Previous study has shown that epithelium is punctuated by discontinuities named "gaps". Confocal laser endomicroscopy could be used as a useful tool for detecting epithelial gaps in vivo, and epithelial gap density in terminal ileum of IBD patients was elevated compared with normal control using CLE. So this study aims to determine whether the density of epithelial gaps in terminal ileum of patients with IBS is different from that in IBD patients and normal controls by CLE, and to evaluate the relationship between the density of epithelial gaps and IBS subtypes, and visceral hypersensitivity.

Eligibility criteria: Inclusion Criteria:

* Bowel habits alterations meeting IBS Rome III criteria and indications for colonoscopy investigation
* Patients with history of inflammatory bowel disease
* Asymptomatic individuals for health surveillance or patients for follow up after polypectomy
* Patients complained of hemafecia but colonoscopy revealed only haemorrhoid

Exclusion Criteria:

* Patients with known cancers or abdominal surgery
* Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass
* Patients who are unwilling to sign or give the informed consent form
* Patients who are allergic to fluorescein sodium
* Patients with impaired cardiac, liver or renal function
* Patients with coagulopathy
* Patients with pregnancy or breastfeeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital
name: Yanqing Li, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05675488: Ultrasound Features of Trigger Finger
Official title: Ultrasound Features of Trigger Finger: A Comparative Study With Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigger Finger
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 30 patients with trigger finger and 30 age and BMI-matched healthy controls

Brief summary: Our aim in this study; to compare the ultrasound findings seen in trigger finger patients with healthy volunteers. Thus, ultrasound findings associated with trigger finger development will be documented

Detailed description: A1 pulley thickness, flexor tendon thickness, and presence of nodules at the MCP joint level of the trigger finger patients will be recorded. The same measurements will be made in age- and sex-matched healthy volunteers, followed by comparison and analysis.

Eligibility criteria: Inclusion Criteria:

* Aged over 18 years
* To have trigger finger (for patient group)
* Not to have trigger finger (for healthy group)

Exclusion Criteria:

* Aged under 18
* Wound or infection in the imaging area

Primary outcomes:
measure: Thickness of flexor tendon
timeFrame: through study completion, an average of one and a half months
measure: Thickness of A1 pulley
timeFrame: through study completion, an average of one and a half months
Secondary outcomes:
measure: Presence of nodules
timeFrame: through study completion, an average of one and a half months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler FTR EAH
Study officials:
affiliation: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Yasin Demir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03149588: Comparison of Propofol and Sevoflurane as Maintaining Anesthetics During General Anesthesia of Cesarean Section
Official title: Comparison of Effects of Propofol and Sevoflurane as Maintaining Anesthetics During General Anesthesia on Maternal and Fetal Outcomes After Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sevoflurane
Propofol
Cesarean Section
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sevoflurane and propofol are the most popular drug choices for maintenance of general anaesthesia for caesarean section. However, effects of these two anesthetics on maternal and fetal outcomes after caesarean section haven't been compared directly. The aim of this study is to compare the effects of sevoflurane and propofol as maintenance of general anesthesia, and to try to determine which anesthetic is better for maternal and fetal outcomes after caesarean section.

Detailed description: General anaesthesia is mostly performed for emergency grade 1 caesarean section and due to a lack of time to apply a neuraxial anaesthesia technique. Rapid sequence induction using propofol and rocuronium should become the standard for general anaesthesia in the obstetric patient. Both sevoflurane and propofol are considered to be appropriate for the maintenance of general anaesthesia during caesarean section. However, effects of these two anesthetics on maternal and fetal outcomes after caesarean section haven't been compared directly in the past. And for most anaesthesiologists, the clinical experience with general anaesthesia for caesarean section is very low. This study is to compare the effects of sevoflurane and propofol as maintenance of general anesthesia.

Eligibility criteria: Inclusion Criteria:

* ASAⅠor Ⅱ parturients (aged 18-35 years) undergoing elective caesarean section

Exclusion Criteria:

* Parturients with severe pregnancy complications

Primary outcomes:
measure: Maternal hospital stay
timeFrame: Before dismissed from hospital
measure: Maternal mortality
timeFrame: Before dismissed from hospital
measure: Newborn hospital stay
timeFrame: Before dismissed from hospital
measure: Newborn mortality
timeFrame: Before dismissed from hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-sen University
Study officials:
References:
citation: Devroe S, Van de Velde M, Rex S. General anesthesia for caesarean section. Curr Opin Anaesthesiol. 2015 Jun;28(3):240-6. doi: 10.1097/ACO.0000000000000185.
Clinical trial NCT01845688: Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy
Official title: Efficacy and Safety Evaluation of QingReMoShen Granule in the Treatment of Idiopathic Membranous Nephropathy : A Randomized Double-Blind Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Membranous Nephropathy
Keywords: Idiopathic Membranous Nephropathy
Traditional Chinese Medicine
Randomized Control Trial
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 72
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: The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen Granule to treat idiopathic membranous nephropathy.


Eligibility criteria: Inclusion Criteria:

* Women and men who had a clinic and biopsy-proven idiopathic membranous nephropathy;
* 6.0g≥24 hour urinary protein≥1.0g;
* serum albumin concentration≥26g/L;
* Chronic Kidney Disease (CKD)≤3 stage (eGFR\>30ml/min/1.73m2 MDRD);
* Willing to participate in the trial and signed an informed consent.

Exclusion Criteria:

* Secondary membranous nephropathy;
* Patients with one of the following circumstances- malignant tumors or malignancy, HIV infection, a history of mental illness, any serious systemic infection, serious gastrointestinal diseases, circulating hepatitis B surface antigens positive or persistent abnormal serum transaminase, abnormal glucose metabolism or diabetes mellitus;
* Pregnant and lactating women;
* Undergoing other clinical trials.

Primary outcomes:
measure: 24-hour urine protein
timeFrame: At the 24thweek
Secondary outcomes:
measure: serum albumin concentration
timeFrame: At the 24thweek
measure: eGFR
timeFrame: At the 24thweek
measure: Alanine transaminase
timeFrame: At the 24thweek
Other outcomes:
measure: T-cell classification
timeFrame: At the 24thweek
Locations:
city: Shanghai
country: China
facility: Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Lin Wang, PHD,MD
role: STUDY_DIRECTOR
References:
citation: von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
Clinical trial NCT01564888: Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial
Official title: Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Occlusion of Artery
Lead sponsor: Total Cardiovascular Solutions
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluating the effect of ulnar artery compression while pressing on radial artery to stop bleeding, in maintaining radial artery potency, after cardiac catheterization through the radial artery. We prospectively plan to compare 3000 patients referred for cardiac catheterization, randomized into two groups, one group receiving radial artery compression for stopping bleeding, in a standard fashion following best practices, and the other group receiving radial artery compression using standard best practices and ulnar artery compression. Radial artery status will be evaluated in 24 hours and 30 days of the procedure to evaluate its potency, using plethysmography.


Eligibility criteria: Inclusion Criteria:

* patients referred for diagnostic cardiac catheterization.

Exclusion Criteria:

* previous ipsilateral radial artery puncture, warfarin therapy, absence of intact palmar collateral circulation, scleroderma, ipsilateral radial artery surgery, lone upper extremity (contralateral upper extremity amputation), ipsilateral upper extremity chronic pain.

Primary outcomes:
measure: 30 day radial artery occlusion
timeFrame: 30 days
Secondary outcomes:
measure: hand ischemia
timeFrame: 2 hours
Other outcomes:
Locations:
city: Pilsen
country: Czechia
facility: University Hospital and Faculty of Medicine
city: Ahmedabad
country: India
facility: V.S. General hospital
state: Gujarat
Study officials:
name: Samir B Pancholy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01135888: Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia
Official title: Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia (Christ-Siemens-Touraine Syndrome)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: X-Linked Hypohidrotic Ectodermal Dysplasia
Exercise-induced Rise of Body Temperature
Keywords: hypohidrotic ectodermal dysplasia
exertional hyperthermia
cooling device
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
Collaborators: name: Pervormance GmbH
First posted: 2010-06-03
Enrollment: 28
Sex: MALE
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with X-chromosomally inherited hypohidrotic ectodermal dysplasia (HED) and age-matched controls

Brief summary: Because of their lack of sweat glands individuals with hypohidrotic ectodermal dysplasia (HED) are at particular risk of life-threatening hyperthermia during exercise in a warm environment. In this study, the effects of physical exercise are investigated in boys and male adolescents with X-chromosomally inherited HED as well as age-matched controls, who undergo standardized exertion on a bicycle ergometer at ambient temperatures of 25°C and 30°C. Body core temperature during and after ergometry, heart rate, performance, and serum lactate as a marker of metabolic stress are measured. Subjects with HED are expected to show an endangering rise of body temperature in connection with physical exercise. To clarify, whether novel cooling devices may reduce the likelihood of overheating, the effects of such devices are evaluated at 30°C.


Eligibility criteria: Inclusion Criteria:

* for patients: hypohidrotic ectodermal dysplasia caused by EDA gene mutations
* regular fluid intake prior to the investigation
* written informed consent

Exclusion Criteria:

* acute febrile illness
* acute or chronic heart disease
* arterial hypertension
* gastrointestinal disorders
* implantable electronic devices
* MRI investigation scheduled for the 5 days subsequent to the study
* clinical signs or diagnostic findings of dehydration

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
state: Bavaria
Study officials:
affiliation: University Hospital Erlangen
name: Holm Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hammersen JE, Neukam V, Nusken KD, Schneider H. Systematic evaluation of exertional hyperthermia in children and adolescents with hypohidrotic ectodermal dysplasia: an observational study. Pediatr Res. 2011 Sep;70(3):297-301. doi: 10.1203/PDR.0b013e318227503b.
Clinical trial NCT00639288: Modification of Cognitive Processing Therapy (CPT-C) for PTSD and Alcohol Dependence
Official title: Modification of Cognitive Processing Therapy (CPT-C) for Posttraumatic Stress Disorder (PTSD) and Alcohol Dependence (AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alcohol Dependence
PTSD
Keywords: Alcohol Dependence
PTSD
CPT-C
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-03-20
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective: To develop a detailed treatment manual that modifies the existing CPT-C treatment protocol to allow for concurrent treatment of PTSD and AD, and to obtain some pilot data regarding its efficacy.

Hypothesis: We predict that CPT-C will significantly reduce the number of drinking days (measured by the Timeline Follow Back Method \[TLFB\]) and reduce the symptoms of PTSD (measured by the \[CAPS and PCL\] scores).

Design: This is a non-randomized, prospective study in which all participants will receive the modified CPT-C for 12 weeks by trained CPT-C clinicians, with each session lasting approximately 1-1.5 hours). Modifications to CPT-C include psychoeducation about alcohol use as an avoidance of PTSD symptoms integrated throughout treatment, integration of coping skills training for AD, weekly breathalyzer tests to measure blood alcohol level, and use and collection of daily dairies of alcohol use.


Eligibility criteria: Inclusion Criteria:

1. Males and females between the ages of 21-65 years old.
2. Current alcohol dependence as determined by the Structured Clinical Interview for DSM-IV Axis I Disorder (SCID; First et al. 1996). Abstinence no more than past 29 days. Primary substance dependence diagnosis of alcohol dependence.
3. Current PTSD as determined by the Clinician Administered PTSD Scale for DSM-IV(CAPS; Blake et al. 1995).
4. Participants on psychiatric medication must be on a stable regimen for at least 2 weeks before treatment begins.
5. Ability to participate psychologically and physically, able to give informed consent and complete assessments, and participate in study procedures.

Exclusion Criteria:

1. Current psychotic disorders
2. Current suicidal or homicidal ideations
3. Current substance dependence other than alcohol or nicotine dependence
4. Legal charges pending with potential of incarceration
5. Unstable serious medical conditions or one requiring acute medical treatments or anticipation of hospitalization for extended care

Primary outcomes:
measure: Alcohol use, PTSD symptoms
timeFrame: 16 weeks
Secondary outcomes:
measure: quality of life
timeFrame: 16 weeks
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System - West Haven Campus
state: Connecticut
Study officials:
affiliation: Yale University
name: Ismene L Petrakis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05259488: Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy
Official title: Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy: a Single-centre Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Surgery
Laparoscopic
Gastric Neoplasm
Digestive Cancer
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All normonourished patients undergoing elective ERAS laparoscopic total gastrectomy for cancer at Minimally Invasive Surgery Unit of Tor Vergata University Hospital

Brief summary: Immunonutrition (IN) appears to reduce infective complications and in-hospital length of stay (LOS) after gastrointestinal surgery. More specifically, it seems to be beneficial also in gastric cancer surgery. Potential benefits of combining preoperative IN (PIN) with protocols of enhanced recovery after surgery (ERAS) in reducing LOS in laparoscopic total gastrectomy are yet to be determined.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Primary gastric cancer
* Preoperative staging I-III
* Eligible for laparoscopic D2 total gastrectomy

Exclusion Criteria:

* Acquired or congenital immunodeficiency
* Malnutrition (MNA-SF score \< 12)
* Preoperative infection
* Previous gastric surgery
* ASA IV
* Emergency setting
* Para-aortic node involvement
* Intraoperative evidence of distant metastasis or peritoneal carcinosis
* Conversion to open surgery

Primary outcomes:
measure: 30-days postoperative complications
timeFrame: up to 30 days after discharge
measure: LOS
timeFrame: up to 30 days after discharge
Secondary outcomes:
measure: Anastomotic leak
timeFrame: up to 30 days after discharge
measure: Pneumonia
timeFrame: up to 30 days after discharge
measure: Ileus
timeFrame: up to 30 days after discharge
measure: Prolonged length of stay
timeFrame: up to 30 days after discharge
measure: Readmission
timeFrame: up to 30 days after discharge
measure: Mortality
timeFrame: up to 30 days after discharge
measure: Time of first defacation
timeFrame: up to 30 days after discharge
measure: Time of tolerated fluid intake
timeFrame: up to 30 days after discharge
measure: Time of tolerated food intake
timeFrame: up to 30 days after discharge
Other outcomes:
Locations:
Study officials:
References:
citation: Franceschilli M, Siragusa L, Usai V, Dhimolea S, Pirozzi B, Sibio S, Di Carlo S. Immunonutrition reduces complications rate and length of stay after laparoscopic total gastrectomy: a single unit retrospective study. Discov Oncol. 2022 Jul 11;13(1):62. doi: 10.1007/s12672-022-00490-5.