louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06082219: Ulcer Bleeding After Band Ligation of Esophageal Varices
Official title: Ulcer Bleeding After Band Ligation of Esophageal Varices:Risk Factors and Prognosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Esophageal Varices
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients having esophageal varices who will undergo endoscopic banding will be included

Brief summary: Primary Outcomes:

assessment of incidence , risk factors and prognosis of post-banding ulcer bleeding following EVL in patients with liver cirrhosis.

Secondary Outcomes:

minimize post-banding ulcer bleeding

Detailed description: Esophageal variceal bleeding represents the most vital complication among patients with liver cirrhosis at rate of 5-15% per year. Endoscopic variceal ligation (EVL), either used as therapeutic in emergency or as prophylactic, is one of the best modalities used in EV treatment. The procedure is effective and generally safe. After banding, a superficial ulcer is formed, which usually heals in 2-3 weeks. The main complications of variceal banding are pain, dysphagia, fever, bleeding during the procedure and post banding ulcer bleeding (PBUB). The prevalence of PBUB is reported to be 3.6-15% . Rebleeding can be fatal, and is mainly resulted from early spontaneous slippage of the rubber bands, before occlusion of the varix with a mature thrombus, leaving an unhealed ulcer . The time frame of variceal rebleeding can be divided into very early rebleeding (within 5 days of acute bleeding), early rebleeding (within 6 weeks of acute bleeding), and delayed rebleeding. Previous reports showed that early rebleeding ranged from 30% to 40% within the first 6 weeks, and was significantly associated with the risk of death within 6 weeks. Therefore, the aim of this research is assessment of incidence , risk factors and prognosis of post-banding ulcer bleeding following EVL in patients with liver cirrhosis, in order to minimize post-banding ulcer bleeding.

Eligibility criteria: Inclusion Criteria:

1. Patients' age is 18 years or above.
2. Patient who are diagnosed with esophageal varices by upper endoscopy.
3. Patient who are fit for surgery to undergo endoscopic banding procedure.

Exclusion Criteria:

1. Pediatric patients.
2. patient refuse to participate at this study

Primary outcomes:
measure: assessment of incidence , risk factors and prognosis of post-banding ulcer bleeding following EVL in patients with liver cirrhosis.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Amna Esmail Mohamed Tammam
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Essam Abdelmonem Sadek
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Muhammad Abbas Said El-Masry
role: STUDY_DIRECTOR
References:
Clinical trial NCT02243319: Investigating the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904
Official title: A Randomized, Open Label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904

Detailed description: Randomized, open-label, multiple dose , 3-treatment, 6-sequence, 3-period, crossover study, The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer, age 19\~45 years
* The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
* History of relevant drug allergies or clinically significant hypersensitivity reaction.

Primary outcomes:
measure: Cmax,ss of HGP1201, HGP0904
timeFrame: 1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h
measure: AUCτ,ss of HGP1201, HGP0904
timeFrame: 1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Hyeong-Seok Lim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05971719: Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks
Official title: Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Air Leak From Lung
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 200
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: Air leaks represent one of the most common complications and postoperative morbidity in thoracic surgery. Air leaks have been associated with the largest preventable morbidity associated with increased costs following lobectomy (typically related to increased length of stay). However, the standard used to detect and localize the air leaks, the submersion test, is not suitable for the standard surgical procedure, Video Assisted Thoracic Surgery. Considering the prevalence of this complication and the absence of a surgical standard of care for such complications, the aim of this study is to develop a system to create and send a glycerine aerosol smoke in the lungs of the patient. The smoke is visible with standard laparoscope and will flow though the pulmonary leak, thereby reducing postoperative surgical complications, morbidity, and length of stay for patients undergoing pulmonary resection.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing lung transplant surgery
* Organ donor ineligible to donate lungs

Exclusion Criteria:

* Healthy individuals

Primary outcomes:
measure: Localization efficacy
timeFrame: 48 months
Secondary outcomes:
measure: Duration of localization
timeFrame: 48 months
measure: Minimal leak localizable
timeFrame: 48 months
measure: Staple lines airtightness
timeFrame: 48 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHUM
Study officials:
References:
Clinical trial NCT04086719: An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.
Official title: An Open-Label, Single Sequence, Crossover Study to Investigate the Effects of OCT1 Inhibition Utilizing Pyrimethamine on Pharmacokinetics of BMS-986165 in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-09-12
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study of what the body does to drug BMS-986165 when it is taken together with pyrimethamine


Eligibility criteria: Inclusion Criteria:

* Patients must be willing and able to complete all study-specific procedures and visits
* Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
* Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
* Normal renal function at screening

Exclusion Criteria:

* Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
* History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
* Additional criteria may apply

Primary outcomes:
measure: Maximum observed serum comcentration (Cmax)
timeFrame: Day 1, Day 5
measure: Area under the concentration-time curve from time zero extrapolated to AUC(INF)
timeFrame: Day 1, Day 5
Secondary outcomes:
measure: Incidences of Adverse Events (AE's)
timeFrame: Approximetly 20 days
measure: Time of maximum observed concentration (Tmax)
timeFrame: Approxmiately 20 days
measure: Half- life time (T-Half)
timeFrame: Day 1, Day 5
measure: Apparent oral clearance (CL/F)
timeFrame: Day 5
measure: Apparent volume of distribution at terminal phase (Vz/F)
timeFrame: Day 5
measure: Ratio of metabolite AUC(0-T) to parent AUC(0-T) corrected for Molecular weight MRAUC(0-T)
timeFrame: Day 5
measure: Ratio of metabolite AUC(INF) to parent AUC(INF) corrected for Moecular weight MRAUC(INF)
timeFrame: Day 5
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences - Salt Lake
state: Utah
Study officials:
References:
Clinical trial NCT06190119: Comparison of Aqueous Humor Adipokines in Glaucoma Patients and Healthy Controls
Official title: Comparative Analysis of Aqueous Humor Adipokines in Patients With Glaucoma and Healthy Controls
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glaucoma
Adipokines
Keywords: Glaucoma；Adipokines；Neuroinflammation
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Beijing Tongren Hospital
First posted: 2024-01-05
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: POAG group and Control group are recruited from people who underwnt anti-glaucoma surgery and cataract surgery.

Brief summary: The purpose of this study is to observe whether there are differences in adipokines in the aqueous humor between patients with primary open-angle glaucoma (POAG) and healthy controls

Detailed description: 1. Inclusion criteria: Patients aged 18 years or older, diagnosed with primary open-angle glaucoma (POAG) and healthy controls (who underwent cataract surgery).

2. Exclusion criteria:

1. Other Ocular Diseases: Patients with concurrent ocular diseases such as macular degeneration, retinal detachment, etc., are excluded.
2. Ocular Surgery History: individuals who have undergone intraocular or laser surgery within the past 6 months, except for uncomplicated cataract surgery.
3. History of Ocular Trauma or Inflammation
4. Systemic Diseases or Mental Disorders: Patients with systemic diseases(e.g., diabetes, rheumatoid arthritis) and those with mental disorders are excluded.
5. Pregnancy or Lactation: Females who are pregnant or lactating are excluded.
6. Presence of any retinal or optic nerve disease other than glaucoma.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older, diagnosed with primary open-angle glaucoma (POAG) and healthy controls (who underwent cataract surgery).

Exclusion Criteria:

* Other Ocular Diseases: Patients with concurrent ocular diseases such as macular degeneration, retinal detachment, etc., are excluded.
* Ocular Surgery History: individuals who have undergone intraocular or laser surgery within the past 6 months, except for uncomplicated cataract surgery.
* History of Ocular Trauma or Inflammation
* Systemic Diseases or Mental Disorders: Patients with systemic diseases(e.g., diabetes, rheumatoid arthritis) and those with mental disorders are excluded.
* Pregnancy or Lactation: Females who are pregnant or lactating are excluded.
* Presence of any retinal or optic nerve disease other than glaucoma.

Primary outcomes:
measure: Concentration of adipokines in aqueous humor
timeFrame: Cross-sectional baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hosipital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Chun Zhang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05390619: Different Doses of vPDT in the Treatment of cCSC
Official title: Comparison of Different Doses of Verteporfin Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Serous Chorioretinopathy
Therapy, Photodynamic
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 100
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: This is a prospective, randomized and controlled clinical trial of photodynamic therapy (PDT) for chronic central serous chorioretinopathy (CSC). The patients who met the inclusion criteria were randomly divided into 50% dose PDT treatment group and 70% dose PDT treatment group. The primary treatment success rate and adverse event rate of the two groups were compared by optical coherence tomography (OCT), and then the best PDT treatment scheme for chronic CSC was summarized.


Eligibility criteria: Inclusion Criteria:

* 18-75 years old, regardless of gender;
* Meet the diagnostic criteria of central serous chorioretinopathy;
* The course of CSC (subject to the symptoms of this disease) is more than 3 months;
* Patients with simultaneous diseases of both eyes were included in those with more subretinal fluid.

Exclusion Criteria:

* macular neuroretinal detachment caused by rhegmatogenous retinal detachment, uveitis, age-related macular degeneration, polypoid choroidal angiopathy and other fundus diseases;
* a previous history of PDT treatment;
* systemic hormone or local hormone nasal spray is being used, or hormone is stopped for less than 3 months.

Primary outcomes:
measure: The complete absorption rate of subretinal fluid
timeFrame: 3 months after the primary PDT
Secondary outcomes:
measure: Central foveal thickness change after the PDT
timeFrame: 12 months after the PDT
measure: Subfoveal choroidal thickness change after the PDT
timeFrame: 12 months after the PDT
measure: Best corrected visual acuity change after the PDT
timeFrame: 12 months after the PDT
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Yuou Yao, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT03375619: Long-term Follow-up Study of Patients Receiving CAR-T Cells
Official title: Long-term Follow-up Study of Patients Receiving CAR-T Cells
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Lymphomas Non-Hodgkin's B-Cell
Lymphoma, Small Lymphocytic
Mantle Cell Lymphoma
Central Nervous System Lymphoma
Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Burkitt Lymphoma
Multiple Myeloma
Keywords: CAR-T Cell Therapy
chimeric antigen receptor
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 500
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: All participants who enrolled in a CAR-T study at Froedtert Hospital \& the Medical College of Wisconsin.

Brief summary: This protocol is designed as a long-term follow-up study of participants who will receive CAR-T cells as part of a clinical trial at the Medical College of Wisconsin/ Froedtert Hospital. The clinical trials include the following:

Phase 1 Study of CAR-20/19-T Cells in Patients with Relapsed Refractory B Cell Malignancies (NCT03019055); Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma (NCT05976555); CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (NCT05094206); LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (NCT05990465); CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (NCT04186520)

Detailed description: The objective is to follow participants receiving CAR-T cells from years 2 to 15 post-treatment for persistence of CAR-T cells, development of secondary malignancies, or other medical complications.

Eligibility criteria: Inclusion Criteria:

* All participants who enrolled in a CAR-T study at Froedtert Hospital \& the Medical College of Wisconsin.

Exclusion Criteria:

* There are no exclusion criteria for this study.

Primary outcomes:
measure: Change from baseline in the incidence of a new malignancy at 5 years.
timeFrame: Baseline to five years.
measure: Change from baseline in the incidence of a new malignancy at 10 years.
timeFrame: Baseline to 10 years.
measure: Change from baseline in the incidence of a new malignancy at 15 years.
timeFrame: Baseline to 15 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital & Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Nirav Shah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02980419: Effects of Prolonged Roll-tilt in Healthy Human Subjects
Official title: Erticality Perception - Effects of Prolonged Roll-tilt in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adaptation Reaction
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The long-term goal of this research is to advance the investigators knowledge of how the brain combines the information of multiple sensory systems coding for spatial oriention and how adaptation to vestibular imbalance influences spatial orientation. In healthy human subjects verticality perception is accurate while upright. After prolonged roll-tilt, humans show a systematic bias in perceived direction towards the previous roll-tilted position (so-called "post-tilt bias"). This effect could either be related to adaptation to the roll-tilted position (shifting the "null" position) or it could be related to changes in torsional eye position due to prolonged static roll-tilt (ocular counter-roll). While in the first case a post-tilt bias is predicted independently of the experimental paradigm used, the second hypothesis predicts a post-tilt bias only if retinal cues are integrated. In order to evaluate these hypotheses, the investigators will assess perceived vertical using both vision-dependent and vision-independent paradigms.


Eligibility criteria: Inclusion Criteria:

* ages 18-65 years
* informed consent
* absence of exclusion criteria

Exclusion Criteria:

* peripheral-vestibular deficit
* disturbed consciousness
* history of sensory deficits
* visual field deficits
* other neurological or systemic disorder which can cause dementia or cognitive dysfunction
* intake of antidepressants, sedatives, or neuroleptics
* pregnancy, unless excluded by a negative pregnancy test
* known neck pain or status post neck trauma

Primary outcomes:
measure: adjustment errors of the subjective visual/haptic/postural vertical in upright position after prolonged whole-body roll-tilt positions.
timeFrame: 10 minutes (i.e. short-term adaptation)
Secondary outcomes:
measure: changes in adjustment errors of the subjective visual vertical when providing an additional optokinetic stimulus
timeFrame: 10 minutes (i.e. short-term adaptation)
measure: changes in adjustment errors of the subjective haptic vertical when providing an additional optokinetic stimulus
timeFrame: 10 minutes (i.e. short-term adaptation)
measure: changes in adjustment errors of the subjective postural vertical when providing an additional optokinetic stimulus
timeFrame: 10 minutes (i.e. short-term adaptation)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Dept. of Neurology
state: ZH
Study officials:
References:
Clinical trial NCT04306796: 3D Printed Made to Measure Splints for Hand Patients
Official title: 3D Printed Made to Measure Splints for Hand Patients - Pilot Feasibility Study and Socioeconomic Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Splints
Keywords: hand trauma
splint
made to measure
3D print
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the feasibility and possible benefits of 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients (intervention group) in comparison to thermoplastic splints individually adjusted by occupational therapists (control group).


Eligibility criteria: Inclusion Criteria:

* Patients presenting to the hand surgical department of the University Hospital Basel
* Patients with hand trauma w/wo the need for hand surgery or patient with planned elective hand surgical intervention
* Indication for immobilization of at least 4 weeks
* Older than 18 years
* Capable of consent
* Informed Consent as documented by signature

Exclusion Criteria:

* Open wounds with tissue loss
* Injury with the need for external fixation
* Younger than 18 years
* Not capable of consent
* Asymmetric deformity or loss of the contra-lateral hand
* Documented hypersensitivity or allergy to Polylactic acid
* Known or suspected non-compliance to agreed treatment measures and/or unexcused nonappearance to hospital appointments
* Drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the current study

Primary outcomes:
measure: Change in patient comfort and satisfaction
timeFrame: at 2-5 days after trauma and/or surgery
measure: Change in patient comfort and satisfaction
timeFrame: at 2 weeks of immobilization during a routine control visit
measure: Change in patient comfort and satisfaction
timeFrame: at 6 weeks of immobilization during what is usually the concluding visit of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie,
Study officials:
References: