louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00626067: Study of Patient Use and Perception of the Travatan Dosing Aid
Official title: Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Travatan Dosing Aid
compliance monitoring dispenser
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2008-02-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective of this study is to determine the opinions of patients who are given the Travatan Compliance Monitoring Dispenser to use to dispense their Travatan glaucoma drops.

Detailed description: Patients enrolled in this study will use the new Travatan compliance monitoring dispenser for 6 weeks. Patients will be informed that some, but not all, patients' compliance will be monitored by the device. Patients are randomly assigned to one of three groups (proportionally in a 2/2/1 ratio):

1. Fully functional Travatan compliance monitor
2. Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact
3. Travatan compliance monitor with LCD display, alarms and compliance monitor disabled.

At end of study, patients fill out questionnaire assessing

1. Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc
2. patient's belief as to whether their compliance was monitored or not

Rates of adherence are compared across groups and with regard to patients' reported beliefs as to whether they were monitored.

The design of this study should allow the clinicians to ethically monitor compliance in patients who do and do not believe that they are being monitored. The use of monitoring devices without a functioning display and alarm should lead to some patients believing that they are not being monitored. As patients are told at the outset that they may or may not be monitored, this should be an ethically acceptable design. However, the collected data will allow a preliminary assessment of the impact of the patients' beliefs as to whether they are being monitored on their actual compliance, and hence an additional potential value of the device.

Eligibility criteria: Inclusion Criteria:

* Open angle glaucoma or ocular hypertension
* Presently using Travatan eye drops

Exclusion Criteria:

* Allergy to prostaglandin

Primary outcomes:
measure: Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser
timeFrame: 6 weeks
Secondary outcomes:
measure: Pilot study of the impact of physician monitoring of compliance on patient compliance
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Wills Eye Institute
name: Jonathan S. Myers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02468167: Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO
Official title: Comparison of Endoscopic Cyanoacrylate Injection Versus Balloon-occluded Retrograde Transvenous Obliteration in the Management of Acute Gastric Variceal Bleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Varices
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 70
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: TREATMENT

Brief summary: The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the management of acute gastric bleeding.


Eligibility criteria: Inclusion Criteria:

1. Cirrhosis
2. Active bleeding from gastric varices (GOV2 or IGV1)
3. Presence of gastrorenal shunt

Exclusion Criteria:

1. Previous pharmacologic therapy combined with endoscopic treatment to prevent rebleeding
2. Previous use of TIPS or surgical shunt
3. Non-cirrhotic portal hypertension
4. Contraindications to cyanoacrylate injection or BRTO
5. Portal cavernoma
6. Hepatorenal syndrome
7. Proven malignancy including hepatocellular carcinoma
8. End-stage renal disease under renal replacement therapy;
9. Cardiorespiratory failure
10. Pregnancy or patients not giving informed consent for endoscopic procedures

Primary outcomes:
measure: The number of participants with failure to control acute bleeding or failure to prevent clinically significant variceal rebleeding within 1 year after enrollment
timeFrame: 1 year
Secondary outcomes:
measure: Mortality rate
timeFrame: 3 years
measure: Eradication rate of gastric varices
timeFrame: 3 years
measure: Number of participants with increase or decrease in the size of gastric varices
timeFrame: 3 years
measure: Number of participants with appearance or worsening of new oesophageal varices
timeFrame: 3 years
measure: Number of participants with appearance or worsening of portal hypertensive gastropathy
timeFrame: 3 years
measure: Number of participants with appearance or worsening of ascites
timeFrame: 3 years
measure: Number of participants with complication
timeFrame: 3 years
measure: Average in-hospital stay
timeFrame: 3 years
measure: Cost of treatment
timeFrame: 3 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT05701540: A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
Official title: A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 338
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the nighttime heartburn improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.

Detailed description: This is a multi-center, double-blind, randomized, active-controlled phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg or 20mg).

Eligibility criteria: Inclusion Criteria:

1. Subjects aged between 19 and 75 years
2. Subjects who have erosive reflux disease or non-erosive reflux disease

Exclusion Criteria:

1. Unable to undergo upper GI endoscopy
2. Symptoms of primary or secondary esophageal movement disorders
3. Subjects who have undergone or are scheduled to undergo surgery that can affect gastric acid secretion(e.g. upper gastrectomy, vagotomy, etc)

Primary outcomes:
measure: Percentage of days without nighttime heartburn during the 2-week dosing period
timeFrame: 2 weeks
Secondary outcomes:
measure: Time to first nighttime hearturn-free interval(days)
timeFrame: 2 weeks
measure: Percentage of days without daytime heartburn during the 2-week dosing period
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Sang Kil Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05909540: A Prospective Study of Natural History and Clinical Outcomes for Basilar Invagination
Official title: A Prospective Study of Natural History and Clinical Outcomes for Basilar Invagination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Basilar Invagination
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with primary basilar depression

Brief summary: A Prospective Study of Natural History and Clinical Outcomes for Basilar Invagination

Detailed description: Since basilar invagination was reported, its pathogenesis has been considered both primary and secondary. Surgical treatment methods emerged in an endless stream, and a hundred schools of thought contend. However, the link between the symptoms and imaging has not been studied in detail. We prospectively enrolled patients with basilar depression, and then explored the natural history of the disease and the clinical outcomes of early intervention.

Eligibility criteria: Inclusion Criteria:

1. BI discovered by the patient not incidentally;
2. Patients with depression of the skull base caused by congenital skeletal developmental malformations and symptoms;
3. The patient was initially treated in our center, and the interval between onset and treatment was at least 1 month or no treatment;
4. The imaging diagnosis of BI meets the standard (3-5mm higher than the Chamberlain's line)

Exclusion Criteria:

1. secondary BI caused by trauma, pathological factors such as rheumatoid arthritis, hyperparathyroidism, osteogenesis imperfecta, rickets, osteomalacia, spinal cord tumors, tuberculosis, inflammation of adjacent structures, and simple AAD, odontoid body deformity, etc.
2. spinal vascular disease, intervertebral disc herniation, tethered spinal cord disease and other diseases that may cause symptoms.
3. Patients with incomplete imaging data or symptomatic data.

Primary outcomes:
measure: improved symptoms
timeFrame: 1 months postoperatively
measure: improved symptoms
timeFrame: 3 months postoperatively
measure: improved symptoms
timeFrame: 6 months postoperatively
measure: improved radiology
timeFrame: 1 months postoperatively
measure: improved radiology
timeFrame: 3 months postoperatively
measure: improved radiology
timeFrame: 6 months postoperatively
measure: operation complication
timeFrame: 1 months postoperatively
measure: operation complication
timeFrame: 3 months postoperatively
measure: operation complication
timeFrame: 6 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital， Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Zan Chen, MD. PHD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06632340: Effect of Tumor Base Size in Bladder Cancer
Official title: Effect of Tumor Base Size on Recurrence and Progression in Non-muscle Invasise Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators aim to investigate the effect of the size of the base of the tumor in contact with the bladder mucosa on recurrence and progression in non-muscle invasive bladder tumors.

Detailed description: Between March 2021 and September 2023, 130 patients who applied to our clinic with complaints of hematuria, dysuria, and suprapubic pain, and who were diagnosed with bladder tumor by imaging methods and underwent TUR-MT were included in the study. The groups were compared in terms of age, gender, smoking, ASA, comorbidities, BMI and the number of tumors, size, stage as intraoperative and postoperative data. Patients with tumor base size \<2 cm were classified as Group

1, while with tumor base size ≥2 cm were classified as Group 2. Kaplan Meier survival analysis without recurrence and without progression were performed after comparing the groups in terms of recurrence and progression.

Eligibility criteria: Inclusion Criteria:

* Bladder Tumor

Exclusion Criteria:

* Invasive Bladder Tumor

Primary outcomes:
measure: Recurrence
timeFrame: 2 year
Secondary outcomes:
measure: progression
timeFrame: 2 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
Study officials:
References:
Clinical trial NCT05540340: A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
Official title: Pharmacokinetic Directed Melphalan for Lymphoma Patients Undergoing Autologous Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lymphoma
Lymphoma, B-Cell
Lymphoma, T-Cell
Lymphoma, Hodgkin
Lymphoma, Non-Hodgkin
Keywords: Pharmacokinetics
Carmustine
Etoposide
Melphalan
Cytarabine
22-086
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether it is practical to use a newer way to calculate melphalan dose given (called population PK model) in BEAM chemotherapy before AHCT. Standard dose is fixed for everybody and is calculated using height and weight. The population PK model, tested in this study, uses information based on people who have previously received melphalan and aims to calculate an optimal dose separately for each person. Study researchers think that the dose calculated using the population PK model may still be effective but have less side effects than the standard melphalan dose.


Eligibility criteria: Inclusion Criteria:

* Age18 - 79 years old
* Diagnosed with any type of lymphoma \[Hodgkin, non-Hodgkin (B- or T-cell)\] and planned for BEAM-AHCT
* KPS \> 70
* Cardiac ejection fraction of \> 45%
* Hemoglobin-adjusted diffusing capacity of carbon monoxide (DLCO) of ≥45%
* Creatinine clearance of ≥ 40 mL/min
* Completion of most recent systemic therapy within 12 weeks of enrollment
* Complete or partial response to systemic chemotherapy by IWG Working Group Criteria.
* Total bilirubin \< 2.0 mg/dL in the absence of suspected Gilbert's disease (if Gilbert's disease is suspected, the total bilirubin must be ≤3.0 mg/dL), and AST \& ALT \< 2.5 ULN.
* Minimum stem cell dose of 2 x 10\*6 CD34+ cells/kg

Exclusion Criteria:

* Disease progression by IWG Working Group since last therapy
* Pregnant or lactating females
* Contraindication to CE melphalan or any of the required supportive treatments, including hypersensitivity to G-CSF or pegfilgrastim
* Any known allergy or allergic reactions to Captisol
* Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial

Primary outcomes:
measure: determine if this target AUC can be achieved
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Parastoo Dahi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02173340: Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol
Official title: Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol in Patients Undergoing Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery Related to Lower Extremity Under Spinal Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who have lower extremity surgery under spinal anesthesia at Gangnam Severance Hospital

Brief summary: Sedation during spinal anesthesia is very useful for patients' comfort. However, intermittent bolus of sedative frequently results in inappropriate sedation which comes with various side effects such as patients' discomfort and apnea. Therefore, it would be reasonable to use target-controlled infusion(TCI) to provide proper sedation without serious side effects.

In this study, the investigators try to find the appropriate propofol target concentration with TCI device and build a pharmacodynamic non-linear mixed effect model between propofol target concentration and side effects.


Eligibility criteria: Inclusion Criteria:

* patients who have lower extremity surgery under spinal anesthesia and who want to be sedated

Exclusion Criteria:

* patients who have deafness, neurologic deficit, Glasgow coma scale less than 15, history of drug allergy and who are on central nervous system-related drugs,

Primary outcomes:
measure: sedation score
timeFrame: every 5 minutes when the dose is adjusted up to 1 hour
Secondary outcomes:
measure: airway obstruction score
timeFrame: every 5 minutes when the dose is adjusted up to 1 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Yonsei University Gangnam Severance Hospital
name: Dong Woo Han, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01741740: Chronic Complaints After Small Umbilical Hernia Repair
Official title: High Incidence of Chronic Complaints and Recurrence 5 Years After Simple Sutured Umbilical Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Ventral Hernia
Keywords: pain, hernia, chronic, discomfort, retrospective
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 295
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: Consecutive patients undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repair during a five years period

Brief summary: There are only little data on the risk of chronic complaints (pain and discomfort) following open non-mesh sutured repairs of small umbilical or epigastric hernias. Our primary and secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly recurrence. The setup was a retrospective two-centre study including patients ≥18 years undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repairs. The survey included questions on suspicion of recurrence, reoperation for recurrence (if yes patients were examined by a consultant in patients home), pain, discomfort, work, and leisure activities. We analysed 295 consecutive patients through a non-validated structured questionnaire.


Eligibility criteria: Inclusion Criteria:

* primary elective open non-mesh sutured umbilical or epigastric hernia repair

Exclusion Criteria:

* mesh repair, acute repair, repair secondary to other operation, recurrent hernia repair, combined hernia repair, laparoscopic hernie repair, trocar hernia repair, incompensated liver cirrhosis, age \< 18 years, pregnancy

Primary outcomes:
measure: pain at rest at the hernia repair site
timeFrame: chronic complaints 5 years after hernia repair
Secondary outcomes:
measure: discomfort at rest at the hernia site
timeFrame: 5 years
Other outcomes:
measure: recurrence
timeFrame: five years
Locations:
Study officials:
affiliation: Hvidovre and Glostrup University Hospitals
name: Thue Bisgaard, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180440: INSURE: INcidence Free SUrvival Before and After Implantable Cardioverter Defibrillator (ICD) Replacement
Official title: INcidence Free SUrvival Before and After ICD Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Fibrillation
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients who are considered for ICD replacement due to normal battery depletion

Brief summary: The INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before and after their first elective ICD replacement.

Detailed description: The INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before \& after their first elective ICD replacement. For this purpose all consecutive ICD patients will be included in the study, whose first implanted device is replaced due to ICD battery depletion (i.e. arrival at battery indicator ERI). ICD replacements due to other reasons can be included if duration of first ICD implantation was \> 3 years. All patients included in the trial are regularly followed up until delivery of their first adequate ICD therapy. The collected data shall provide statistically valid information about the risk to patients who never have experienced adequate ICD therapy before the ICD replacement investigated in this study. In the future, these statistical risk data can give additional information to implanting physicians, such as whether an ICD replacement can eventually be omitted in those patients who are at very low risk for the occurrence of ICD therapies. All actually available GUIDANT ICDs with CE certificate can be implanted in this trial.

Eligibility criteria: Inclusion Criteria:

* All elective ICD replacements due to battery depletion of the first ICD being implanted in the patient

Exclusion Criteria:

* Non-availability to regular follow-up
* Age \< 18 years
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: IKKF, Insitut für Klinisch-kardiovaskuläre Forschung
Study officials:
affiliation: Kerckhoff Klinik
name: Johannes Sperzel, MD
role: PRINCIPAL_INVESTIGATOR
References: