louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05795309: Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis
Official title: Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroparesis
Type 1 Diabetes
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Staggered randomised control trial
Primary purpose: TREATMENT

Brief summary: This is a staggered randomised controlled trial that aims to assess the impact of an automated insulin delivery (AID) system on glucose, gastrointestinal and patient-reported outcomes.

Detailed description: Following a run-in period of 2 weeks, participants will be randomised to control or hybrid automated insulin delivery (AID) using the 780G system and will remain in the intervention phase of the study for 12 weeks (4-week control, then 4-week AID or Control and finally 4-week AID). The total duration for each participant will be 14 weeks. There are 5 study visits (combination of face to face or/and remote) and two telephone visits in total.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years of age or older
* Type 1 diabetes confirmed on the basis of clinical features
* Type 1 diabetes for greater than 1 year
* On an intensified insulin regimen with multiple dose injection or insulin pump for \> 3 months
* HbA1c \>7.5% (58mmol/mol) (or %TIR 3.9-10mmol/L \<52% for participants already using a continuous glucose sensor)
* Gastroparesis Cardinal Symptom Index (GCSI) ≥ 18 or evidence of delayed gastric emptying on nuclear medicine gastric emptying study

Exclusion Criteria:

* Enrolled in other clinical trials
* Estimated glomerular filtration rate of ≤30ml/min
* Pregnant or planning pregnancy
* Have active malignancy or under investigation for malignancy
* Severe visual impairment
* Reduced manual dexterity
* Use of any automated insulin delivery system
* Unable to participate due to other factors, as assessed by the Chief Investigator

Primary outcomes:
measure: Percentage time spent in glucose target (3.9-10mmol/L)
timeFrame: 4 - 8 weeks
Secondary outcomes:
measure: Percentage time spent in hypoglycaemia (<3.0mmol/L)
timeFrame: 4 - 8 weeks
measure: Percentage time spent in hypoglycaemia (<3.9mmol/L)
timeFrame: 4 - 8 weeks
measure: Percentage time spent in hyperglycaemia (>10mmol/L)
timeFrame: 4 - 8 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London and Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Nick Oliver
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01708109: Optimal Handling of Common Bile Duct Calculus, a Prospective Study
Official title: Optimal Handling of Common Bile Duct Calculus, a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cholelithiasis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Danderyd Hospital
name: Sodertalje Hospital
name: Mora Hospital
name: Regional Hopspital Ryhov, Jönköping
name: University Hospital, Linkoeping
name: Vrinnevi Hospital, Norrköping
name: Sundsvalls Hospital
First posted: 2012-10-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose is to study natural process of gallstones in common bile duct, stones less than or equal to 6 mm. And if the gallstones give any complications under 1 year follow up. The second outcome is to study side-effects of gallstones removed with surgery.


Eligibility criteria: Inclusion Criteria:

* cholecystectomy

Exclusion Criteria:

* Ongoing icterus or pancreatitis
* History of anamneses pancreatitis/icterus
* Allergy against x-ray contrast
* Stones more than 6 mm in ductus
* No passage of contrast to duodenum
* malignant

Primary outcomes:
measure: Natural process of biliary calculus left after cholecystectomy
timeFrame: 12 month post op
Secondary outcomes:
measure: Complications biliary calculus
timeFrame: 12 month post op
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Regional Hospital Ryhov
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Mora
country: Sweden
facility: Mora Hospital
city: Norrköping
country: Sweden
facility: Vrinnevi Hospital Norrköping
city: Stockholm
country: Sweden
facility: Ersta sjukhus
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Danderyds Hospital
city: Sundsvall
country: Sweden
facility: Sundsvalls Hospital
city: Södertälje
country: Sweden
facility: Södertälje Hospital
Study officials:
affiliation: Karolinska Institutet
name: Anders Thorell, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01679509: Study of Laparoendoscopic Single Site Adnexal Surgery for Benign Ovarian and Tubal Disease
Official title: Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Adnexal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Ovarian or Tubal Disease
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 330
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety and efficacy between single-port and three-port adnexal surgery in patients with benign ovarian and tubal disease


Eligibility criteria: Inclusion Criteria:

* Patient who undergo laparoscopic adnexal surgery due to following benign adenxal disease

  1. Benign teratoma
  2. Endometrioma
  3. Mucinous cystadenoma
  4. Serous cystadenoma
  5. Benign Brenner tumor
  6. Ectopic pregnancy(cornual, tubal, ovarian pregnancy, etc.)
  7. paratubal cyst, parovarian cyst
  8. Risk reducing bilateral salpingooophorecotmy due to familial breast/ovarian cancer syndrome
  9. Other benign adnexal disease requiring surgery
* American Society of Anesthesiologist Physical Status classification I-II.
* Patient who have signed written informed consent

Exclusion Criteria:

* Uncontrolled medical disease
* Active infectious disease
* Previous pelvic radiation therapy
* Patient who requires further procedure excluding adnexal surgery
* Patient who has other pain source excluding adnexal disease
* Pregnant and lactating woman

Primary outcomes:
measure: postoperative hospital stay
timeFrame: within 1 week after surgery
Secondary outcomes:
measure: postoperative pain
timeFrame: within 1 week after surgery
measure: postoperative analgesics requirement
timeFrame: within 1 week after surgery
measure: quality of life
timeFrame: within 6 months aftr surgery
measure: surgical stress response
timeFrame: within 2 days after surgery
measure: operating time
timeFrame: immediately ater surgery
measure: transfusion requirement and amount
timeFrame: within 1 week after surgery
measure: postoperative complication
timeFrame: within 1 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology, Universit of Ulsan College of Medicine, Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Joo-Hyun Nam, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04210609: Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers
Official title: Treating Non-healing Foot Wounds With Vaporous Hyperoxia Therapy as an Adjunct to Standard Wound Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Vaporox
Sponsor class: INDUSTRY
First posted: 2019-12-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.

Detailed description: The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers. VHT treatments will be provided as an adjunct to standard wound care. Subjects will receive VHT treatments until wound closure, or for the treatment period of 20 weeks.

Eligibility criteria: Inclusion Criteria:

* Diabetic foot wound, graded by the Wagner Scale as a 1,2 or 3
* Wound has resisted healing with standard wound care for at least 6 weeks
* No symptoms of sepsis
* Able to maintain reasonable nutrition and hydration
* Able to maintain adequate home care between treatment visits
* Able to understand and follow basic wound care instructions, or has caregiver who can assist

Exclusion Criteria:

* Skin wounds cancer/neoplastic etiology
* Wounds that involve osteomyelitis or tendon involvement
* Diagnosis of methicillin resistant staph aureus by wound swab
* Acute skin conditions
* Surgery within 30 days of study onset
* Wounds where the end cannot be probed
* Participation in another clinical trial within 120 days prior to study onset
* Non-compliant patients
* Pregnancy
* Presence of co-morbid conditions that in the physician's opinion exclude the individual from the study

Primary outcomes:
measure: Wound closure rate at 20 weeks
timeFrame: 20 weeks
Secondary outcomes:
measure: Wound closure rate at 12 weeks
timeFrame: 12 weeks
measure: Time to 50%, 75%, 100% wound closure
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Castle Rock
country: United States
facility: Rock Canyon Foot and Ankle Clinic
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Foot and Ankle Center
state: Colorado
city: Denver
country: United States
facility: Colorado Foot and Ankle
state: Colorado
Study officials:
affiliation: Rocky Mountain Foot and Ankle Center
name: Dustin Kruse, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03438409: Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training
Official title: Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate changes in response to robotic gait training in individuals with a traumatic brain injury.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* traumatic brain injury at least 6 months prior to study

Exclusion Criteria:

* currently receiving outpatient therapy
* medically unstable
* body weight \> 150 kgs

Primary outcomes:
measure: Change in Functional Gait Outcomes
timeFrame: Change from baseline gait speed to post-test up to 6 weeks following the intervention.
measure: Change in Endurance
timeFrame: Change from baseline distance covered to post-test up to 6 weeks following the intervention.
Secondary outcomes:
measure: Change in balance
timeFrame: Change from baseline balance to post-test up to 6 weeks following the intervention.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
References:
Clinical trial NCT07013409: Probiotics' Effects on Hormones, Body and Mood in Obese Women
Official title: Modulatory Effects of L. Rhamnosus LRa05 and L. Reuteri LR08 Probiotics on Hormone Metabolism, Body Composition, and Mood in Obese Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Women
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the regulatory effect of probiotics formula on visceral fat metabolism and sex hormone balance in obese women.


Eligibility criteria: Inclusion Criteria:

Age: 18 to 40 years old, female, BMI ≥ 25 kg/m2. Be willing to receive follow-up during the intervention period. Be willing to provide two blood, urine and fecal samples during the intervention period.

Be willing to take the compound probiotics by oneself every day during the intervention period.

Have good hearing and be able to hear and understand all instructions during the intervention period.

-

Exclusion Criteria:

Suffering from digestive system diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease).

Suffering from severe neurological disorders (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, long-term coma - excluding general anesthesia).

Have received/are currently receiving treatment for the following mental illnesses: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder.

Take medication for depression or low mood. Suffering from internal organ failure (such as heart, liver or kidney failure, etc.).

Have received radiotherapy or chemotherapy in the past. Have received general anesthesia surgery/procedures within the past three years, or plan to receive general anesthesia procedures/surgeries within the next three months during this trial.

Have suffered from hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past.

-

Primary outcomes:
measure: The changes of estradiol before and after the intervention
timeFrame: 0, 1, 2, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
Clinical trial NCT02326909: Diagnostic Accuracy of Optical Coherence Tomography in Upper Urinary Tract Urothelial Carcinoma
Official title: a Prospective In-vivo Human Study to Assess the Diagnostic Accuracy of Optical Coherence Tomography for Diagnosis and Staging of Upper Urinary Tract Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transitional Cell Carcinoma of Urinary Tract
Keywords: Upper Urinary Tract
Optical Coherence Tomography
Transitional Cell Carcinoma
Urothelial Cell Carcinoma
Diagnostic accuracy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to establish in vivo sensitivity and specificity of OCT in the diagnosis of Upper Urinary Tract Urothelial Carcinoma.

Detailed description: Minimal invasive endoscopic treatment for Upper Urinary Tract Urothelial Carcinoma (UUT-UC) has been accepted as a treatment option instead of radical nephroureterectomy for patients with low grade, low stage disease. For this reason, information on tumour stage and grade is important for a clinical decision. Until now,diagnostic ureterorenoscopy combined with histology/cytology is the gold standard. Unfortunately, histology/cytology is often inconclusive.

Optical Coherence Tomography is a new high resolution imaging technique that has potential to provide the urologist real time per-operative information of grade and stage of the disease.

In this study the investigators aim to establish in vivo sensitivity and specificity of OCT in the diagnosis of Upper Urinary Tract Urothelial Carcinoma. Secondary objectives are inter-observer variability of 1300 nm OCT in the diagnosis of UUT-UC and optical properties of cancerous and healthy ureter and collecting system tissue in vivo in humans.

Eligibility criteria: Inclusion Criteria:

* Candidate for diagnostic or therapeutic ureterorenoscopy
* Signed informed consent

Exclusion Criteria:

* No signed informed consent

Primary outcomes:
measure: Sensitivity of 1300nm OCT in grading and staging UUT-UC
timeFrame: up to 10 minutes
measure: Specificity of 1300nm OCT in grading and staging UUT-UC
timeFrame: up to 10 minutes
Secondary outcomes:
Other outcomes:
measure: Optical properties of cancerous and healthy ureter and collecting system tissue
timeFrame: up to 10 minutes
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jean J. de la Rosette, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bus MT, Muller BG, de Bruin DM, Faber DJ, Kamphuis GM, van Leeuwen TG, de Reijke TM, de la Rosette JJ. Volumetric in vivo visualization of upper urinary tract tumors using optical coherence tomography: a pilot study. J Urol. 2013 Dec;190(6):2236-42. doi: 10.1016/j.juro.2013.08.006. Epub 2013 Aug 13.
Clinical trial NCT04799509: Assessment of the 90-day Mortality Risk Score After VATS Lobectomy
Official title: Assessment of the 90-day Mortality Risk Score After Video-assisted Thoracoscopic Lobectomy in the Italian VATS Group Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Surgery--Complications
Morality
Keywords: non-small cell lung cancer
VATS lobectomy
90-day postoperative mortality
risk score
validation
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 2209
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients were selected from the Italian VATS Group registry (a database containing prospectively collected data on VATS anatomical lung resection performed in 58 certified thoracic surgery centers from January 1st 2014). The VATS Group database was awarded by the European Society of Thoracic Surgeons in the 2017

Brief summary: A five classes (A-E) aggregate risk score predicting 90-day mortality after video-assisted thoracoscopic lobectomy for lung cancer, including as independent factors male sex (3 points), carbon monoxide lung diffusion capacity \<60% (1 point) and operative time \>150 minutes (1 point), has been recently published. This study aims to assess the effectiveness and reliability of this risk model in a large, independent cohort of patients, in order to confirm its generalizability.

Detailed description: From the Italian VATS Group Database, we selected patients who underwent video-assisted thoracoscopic lobectomy for non-small cell lung cancer. We calculated the aggregate risk score and the corresponding class of 90-day mortality risk for each patient. The correlation between risk classes and mortality rates was tested by Spearman's rho-test. Model calibration was evaluated by Hosmer-Lemeshow goodness-of-fit test.

Eligibility criteria: Inclusion Criteria:

- Patients undergoing VATS lobectomy for non-small cell lung cancer

Exclusion Criteria:

* Incomplete data for risk score calculation
* Tumor size \>5 cm
* Follow-up \<3 months
* Patients undergoing neoadjuvant treatment
* Patients undergoing extended resection

Primary outcomes:
measure: 90-day postoperative mortality
timeFrame: 90 day post surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Andrea Imperatori, MD
role: STUDY_DIRECTOR
References:
citation: Brunelli A, Dinesh P, Woodcock-Shaw J, Littlechild D, Pompili C. Ninety-Day Mortality After Video-Assisted Thoracoscopic Lobectomy: Incidence and Risk Factors. Ann Thorac Surg. 2017 Sep;104(3):1020-1026. doi: 10.1016/j.athoracsur.2017.02.083. Epub 2017 Jun 1.
Clinical trial NCT01208909: Combined Approach to Resection of Glioblastoma (GBM) by 5-Aminolevulinic Acid (5-ALA) and Intraoperative Magnetic Resonance Imaging (MRI)
Official title: Combined Approach to GBM-resection by 5-ALA and Intraoperative MRI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioblastoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-09-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Glioblastoma multiforme (GBM)

Brief summary: In the treatment of glioblastoma (GBM) neurosurgical resection of the tumor is usually considered a a first step of effective therapy. Radical resection of the tumor is highly beneficial to the patient as measured in progression-free survival and overall survival. At the same time eloquent areas of the brain have to remain intact to preserve quality of life.

Both 5-ALA fluorescence and intraoperative MRI are used for intraoperative marking of tumor tissue and thereby to improve precision of GBM-Resection.

We now study whether the combination of 5-ALA fluorescence and intraoperative MRI increases the number of sites where tumor tissue can be detected.

- Trial with surgical intervention

Detailed description: Precision of GBM-Resection Intraoperative marking of tumor tissue Combination of 5-ALA fluorescence and intraoperative MRI

Eligibility criteria: Inclusion criteria:

* patients with Glioblastoma multiforme (GBM)
* no other tumor types or metastases

Exclusion criteria:

* Allergy against 5-ALA or Porphyrin
* Porphyria
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: UniversitätsSpital Zürich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: René L Bernays, MD
role: STUDY_DIRECTOR
References: