louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05512572: Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion
Official title: Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chalazion
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study method: This test screened the subjects first, and proposed to include 50 subjects with primary or recurrent eyelid plate gland cysts without obvious surgical indications. All subjects underwent three strong pulsed light therapy combined with eyelid plate gland massage, treatment of local anesthesia eye drops, and metal pads were placed in conjunctival sac protection. Eye protection, using the M22 strong pulsed light small optical treatment head of the medical company, energy selection 14-16J/cm2, laser position is selected on the upper and lower eyelids, 3mm away from the root of the eyelashes. Each interval is 3 weeks. Eye-related examinations were performed before treatment and 3 times after treatment. The evaluation content included: ocular surface, slit lamp observation, anterior segment photography, intraocular pressure, vision, corneal fluorescein staining, tear film rupture time, eyelid plate gland evaluation, eyelid plate gland cyst relief, eyelid plate gland cyst recurrence rate.


Eligibility criteria: Inclusion Criteria:

* Patients had primary or recurrent eyelid plate gland cyst without obvious surgical indications

Exclusion Criteria:

* (1) any intraocular inflammation, ocular infection, allergy, ocular surgery, or ocular trauma in the past 6 months; (2) any eyelid diseases or structural abnormality; (3) any systematic diseases may lead to dry eye or MGD; (4) skin cancer or pigmented lesion in the treatment zone.

Primary outcomes:
measure: Recurrence rate of chalazia
timeFrame: An average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT00002172: An Expanded Access Open-Label, Compassionate Use Protocol of Remune in HIV-1-Infected Adults With CD4 Count Less Than 300 Cells/Ml
Official title: An Expanded Access Open-Label, Compassionate Use Protocol of Remune in HIV-1-Infected Adults With CD4 Count Less Than 300 Cells/Ml
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS Vaccines
CD4 Lymphocyte Count
Salk HIV Immunogen
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To provide product through an expanded access program to HIV-infected patients with CD4 counts less than 300 cells/ml.


Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV-1 seropositivity.
* CD4 counts \< 300 cells/ml.

NOTE:

* If a patient's CD4 count is 275 to 300 cells/ml, the patient must either rescreen for Study 806 or wait 6 months before entering the expanded access program.
* Patient must have failed or been intolerant to other comparable or alternative marketed therapies or must not be a candidate for such therapies.
* Patient must not meet inclusion criteria for other Remune trials.
* Patient must have laboratory tests within specified limits.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Clinically significant cardiac, hepatic, renal, or gastrointestinal dysfunction.
* Current participation in a Remune study.

Concurrent Medication:

Excluded:

* Use of any immune-modulating drugs.
* Induction therapy or initiation of new treatment regimen for an AIDS-defining condition.

Patients with any of the following prior conditions are excluded:

Previous participation in a Remune study.

Prior Medication:

Excluded:

* Use of any immune-modulating drugs within 3 months of Day 1 visit.
* Induction therapy or initiation of new treatment regimen for an AIDS-defining condition within 30 days of Day 1 visit.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Immune Response Corp
state: California
Study officials:
References:
Clinical trial NCT01190072: Lipid-lowering Therapy for Secondary Prevention in Patients Undergoing Elective Percutaneous Coronary Intervention (PCI)
Official title: LIPID-LOWERING THERAPY FOR SECONDARY PREVENTION IN PATIENTS UNDERGOING ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI) A 10-week, Open-label, Non-interventional Study of Total Cholesterol/LDL-cholesterol Management in Real Life in Coronary Patients Hospitalised for Elective PCI
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Keywords: Blood lipids
percutaneous coronary intervention
lipid lowering treatment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 120
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: Secondary care clinic

Brief summary: The purpose of the study is to follow the management of blood lipids in patients with planned percutaneous coronary intervention (widening of coronary vessels) in a period from 6 to 10 weeks after the intervention.


Eligibility criteria: Inclusion Criteria:

* Male or nonpregnant female
* Coronary patient hospitalised for elective PCI
* Hypercholesterolaemia defined as LDL-C ≥ 2 mmol/L

Exclusion Criteria:

* Any chronic inflammatory condition
* Chronic anti-inflammatory pharmacotherapy (except low-dose ASA)

Primary outcomes:
measure: Serum total cholesterol concentration
timeFrame: Week 0
measure: Serum total cholesterol concentration
timeFrame: Once during the time period between Week 6 and Week 10
measure: Serum LDL cholesterol concentration
timeFrame: Week 0
measure: Serum LDL cholesterol concentration
timeFrame: Once during the time period between Week 6 and Week 10
Secondary outcomes:
measure: Proportion of patients achieving LDL-C < 2 mmol/L
timeFrame: Once during the time period between Week 6 and Week 10
measure: Proportion of patients achieving total cholesterol < 4 mmol/L
timeFrame: Once during the time period between Week 6 and Week 10
measure: Change of hsCRP levels from baseline
timeFrame: Once during the time period between Week 6 and Week 10
Other outcomes:
Locations:
city: Maribor
country: Slovenia
facility: Research Site
Study officials:
affiliation: University Medical Centre Maribor
name: Vojko Kanic
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06343272: Lymphocyte Enhancement in Gastroenteric Oncology
Official title: Effects of a Supplementation With a Mixture of Essential Amino Acids on Enhancing the Number of Circulating Lymphocytes and Improveing the Tolerance to Chemotherapy Treatment in Patients With Advanced Gastroinmtestinal Malignances the LEGO Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Gastrointestinal Cancers
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: University of Pavia
First posted: 2024-04-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: LEGO is single center double-blind randomized trial aimed at testing the efficacy of an essential ammino acid (EAA) supplementation in improving the absolute count of peripheral lymphocytes and the tolerance to chemotherapy in patients with advanced gastrointestinal malignancies not candidates to immune check-point inhibitors containing regimens.

Detailed description: The aim of the study is to verify that, in lymphopenic patients, AAE supplementation leads to an increase in lymphocytes circulating in the blood. In particular, at the end of treatment, in patients with lymphocytes \< 29.7% of the total number of white blood cells, we want to observe the disappearance of lymphopenia.

Eligibility criteria: Inclusion Criteria:

* diagnosis of epithelial neoplasia of the gastrointestinal tract in advanced stage with indication for first-line chemotherapy for palliative purposes and with circulating lymphocytes \< 29.7% of the number total white blood cells in the blood.
* ECOG PS ≤ 2
* start of first-line palliative chemotherapy agreement with AIOM guidelines.
* adequate nutritional counseling carried out before starting of the treatment
* willing to participate by providing written informed consent

Exclusion Criteria:

* age \< 18 years
* current or indicated artificial nutrition
* gluten intolerance
* prediction of use of granulocyte growth factors
* confirmed diagnosis of COPD, chronic heart failure, insufficiency chronic kidney disease, chronic liver failure, collagen disease, diseases endocrine, insulin-dependent diabetes, malignancy in other locations. All these conditions are associated with documented alterations in the plasma profile of amino acids and potentially of subsets of circulating T lymphocytes.

Primary outcomes:
measure: Exit from lymphopenia
timeFrame: 60 days
Secondary outcomes:
measure: The change in the % of lymphocytes over time
timeFrame: 0, 30, 60, 90 days
measure: The proportion of patients with G3-G5 toxicity
timeFrame: 60 days
measure: The percentage of chemotherapy dose administered compared to that expected for the patients.
timeFrame: 60 days
measure: plasma aminoacids composition chang during treatment
timeFrame: 60 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
Study officials:
References:
Clinical trial NCT06887972: A Single-Arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Aesthetic or Reconstructive Surgeries
Official title: A Phase 4, Open-label, Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine As Part of Multimodal Therapy for Acute Pain After Aesthetic or Reconstructive Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2025-03-21
Enrollment: 100
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 to evaluate the effectiveness, safety, and tolerability of SUZ as part of multimodal therapy (MMT) in treating acute postoperative pain.


Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of greater than or equal to (≥)18.0 to less than or equal to (≤) 40.0 kilogram per meter square (kg/m\^2)
* Participants scheduled to undergo an aesthetic or reconstructive surgical procedure that would typically be treated with opioid therapy for at least 72 hours postoperatively

Key Exclusion Criteria:

• Participated in a previous study with SUZ or received Journavx

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global assessment (PGA) for Pain Control at the end of Treatment
timeFrame: From Day 3 up to Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Bellaire
country: United States
facility: HD Research LLC | First Surgical Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Village
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
References:
Clinical trial NCT01513772: The Effect of Dexmedetomidine on the Emergence Agitation in Nasal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Extubation
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators examined the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in nasal surgery

Detailed description: Emergence agitation during the immediate postanesthetic period is common. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters. Emergence agitation is common in ENT surgery. The aim of this study is to evaluate the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in adult patients undergoing nasal surgery.

Eligibility criteria: Inclusion Criteria:

* age ≥ 20,
* ASA class I and II,
* nasal surgery

Exclusion Criteria:

* bradycardia (\< 45 bpm),
* heart block,
* liver failure,
* renal failure,
* uncontrolled hypertension,
* body mass index ≥ 30 kg/m2

Primary outcomes:
measure: Emergence agitation
timeFrame: 20min
Secondary outcomes:
measure: Postoperative quality of recovery
timeFrame: 1 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04680572: Functional Outcome After Arthroplasty
Official title: Functional Outcome After Dual Mobility Cups Total Hip Replacement Versus Bipolar Hemiarthroplasty in Fracture Neck of Femur in Active Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture Neck of Femur
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 33
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bipolar hemiarthroplasty (BA) has long been the preferred treatment and is performed in most fracture neck of femur (FNF) cases. It is justified by the reasonable operative time, low blood loss and acceptable functional outcomes. The dual mobility cup total hip replacement (DMTHA) has emerged as a relevant alternative to BA. Since then, there is an on-going debate on the best implant to use. Age, co-morbidities, patient independence and potential surgical complications must be considered when deciding between implants. The risk of dislocation is a crucial factor because of its important consequences. The investigators evaluated the functional and mechanical outcomes of BA versus DMTHA in FNF in active elderly patients.


Eligibility criteria: Inclusion Criteria:

* active patients
* displaced fracture neck of femur
* age from 60 to 80

Exclusion Criteria:

* ipsilateral previous hip surgery
* grade 3 hip osteoarthritis according to tonnis classifiction
* dysplastic acetabulum

Primary outcomes:
measure: functional outcome using the Harris hip score
timeFrame: 2 years
measure: rate of dislocation
timeFrame: 2 years
Secondary outcomes:
measure: operative time in minutes
timeFrame: 45 minutes to 2 hours
measure: blood loss in cc
timeFrame: during the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university hospitals
Study officials:
affiliation: Faculty of Medicine Ain Shams university
name: Ibrahim M Ganzoury, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00586872: Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
Official title: Endoscopic Mucosal Resection in Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus
Early Esophageal Adenocarcinoma
Keywords: Endoscopic Mucosal Resection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 1000
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: patients who have had endoscopic mucosal resection

Brief summary: Existing records will be reviewed to evaluate the predictors of complications including stricture formation, bleeding or perforation associated with endoscopic mucosal resection

Detailed description: Barrett's esophagus (BE) is a complication of gastroesophageal reflux disease in which the normal squamous lining of the esophagus is replaced by specialized columnar epithelium.1 Approximately 5%-10% of patients diagnosed with BE are thought to be at risk of developing esophageal adenocarcinoma.2 Patients with high-grade dysplasia (HGD) on biopsy are at the greatest cancer risk³. EMR is being performed clinically in our Barrett's Esophagus Unit on a regular basis during endoscopy for patients with Barrett's Esophagus and/or early esophageal adenocarcinoma. There are two predominant endoscopic mucosal resection (EMR) techniques exist using FDA approved devices - the EMR cap method using a transparent cap/snare combination and the endoscopic variceal ligation method using a band ligator/snare combination to resect tissue.

Eligibility criteria: Inclusion Criteria:

* Barrett's Esophagus Early Esophageal Adenocarcinoma History of Endoscopic Mucosal Resection

Exclusion Criteria:

* NA

Primary outcomes:
measure: Number and types of adverse events in participants who have undergone endoscopic mucosal resection with documented adverse events will be evaluated for predictors of complications
timeFrame: 3 months after EMR procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Cadman Leggett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01385072: Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies
Official title: Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Relapsed and Refractory Acute Leukemia
Keywords: acute leukemia
relapse
induction failure
allogeneic transplantation
graft versus leukemia effect
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-06-29
Enrollment: 10
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: Patients with active acute leukemia have dismal prognoses even with allogeneic transplantation.Thus,new measures to enhance graft versus leukemia effect and reduce relapse rates are needed.

Relapse risk after double umbilical cord transplantations have been shown to be significantly lower compared to matched sibling and matched unrelated donor transplantations due to better graft versus leukemia effect.

The investigators hypothesize, that concomitant transplantation from 2 matched siblings may improve GVL effect and reduce relapse rate in patients with high risk acute leukemias and other high risk hematological malignancies.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Patients with refractory or relapsed acute leukemia unable to receive myeloablative conditioning.
3. Patients with refractory or relapsed acute leukemia able to receive myeloablative conditioning but with the following factors:

   AML- 2 or more of the following: duration of CR1 \< 6 months, poor cytogenetics, circulating blasts, karnofsky \< 90.

   ALL- age \> 40 or second and additional relapse, or 2 or more of the following: BM blasts \> 25%, age 18-39,first refractory relapse, donor CMV positive.
4. Patients with 2 matched siblings and donor age \> 18 years old.
5. Patients with advanced multiple myeloma with life expectancy of less than 6 months with standard therapy or transplantation.
6. Patients with advanced lymphoma with life expectancy of less than 6 months with standard therapy or transplantation.

Exclusion Criteria:

1. Patient age \< 18 years.
2. Donor age \< 18 years.
3. Patients in remission or not fulfilling above disease criteria -

Primary outcomes:
measure: Acute graft versus host disease rate,severity and response to treatment
timeFrame: 100 days
Secondary outcomes:
measure: relapse rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Davidoff Cancer Center, Beilin hospital, Rabin medical center
Study officials:
affiliation: Davidoff cancer center, Beilinson hospital, Rabin Medical Center
name: Moshe Yeshurun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01728272: Influence of CPB and Mini CPB to the Absorption of the Metoprolol
Official title: Influence of CPB and Mini CPB to the Absorption of the Metoprolol After CABG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug Absorption
Keywords: metoprolol, atrial fibrillation
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2012-11-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion.

Detailed description: Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion.

Blood samples for concentration of metoprolol are taken preoperaively, 1. and 3. day after operation, before and 10 times after intake of 50 mg metoprolol.

Sudy is randomized into 3 groups: 1. Miniperfusion n.15 2. Perfusion n.15 3. offpump n.15

Eligibility criteria: Inclusion Criteria: elective CABG patient -

Exclusion Criteria: contraindication to metoprolol

-

Primary outcomes:
measure: absorbtion of the metoprolol
timeFrame: one year
Secondary outcomes:
measure: atrial fibrillation
timeFrame: one year
Other outcomes:
measure: recovery from rocedure
timeFrame: one year
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
References: