louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05634629: Anterior Lamellar Recession vs Bilamellar Tarsal Rotation in Upper Lid Cicatricial Trichiasis
Official title: Anterior Lamellar Recession vs Bilamellar Tarsal Rotation in Upper Lid Cicatricial Trichiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cicatricial Trichiasis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 45
Sex: ALL
Minimum age (years): 48
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: in recent years there has been a significant shift from this destructive procedure to a reconstructive procedure such as Anterior Lamellar Recession (ALR) and Bilamellar Tarsal Rotation (BLTR).


Eligibility criteria: Inclusion Criteria:

* patients with upper lid cicatricial trichiasis that requires surgical intervention

Exclusion Criteria:

* Refusal of the patients.
* Associated entropion., 3) Severe ocular surface disease.
* Previous eyelid surgery.
* Associated lid laxity.
* Lack of adequate follow-up

Primary outcomes:
measure: lid correction
timeFrame: at 1 month post operative
measure: lid correction
timeFrame: 3 months postoperative
measure: lid correction
timeFrame: 6 months postoperative
measure: Cosmetic Satisfaction
timeFrame: at 1 months post operative
measure: Cosmetic Satisfaction
timeFrame: at 3 months post operative
measure: Cosmetic Satisfaction
timeFrame: at 6 months post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Damieta
country: Egypt
facility: Ehab tharwat
state: New Damietta
Study officials:
References:
Clinical trial NCT00577629: Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma
Official title: Dose-Intensive Chemotherapy Combined With Monoclonal Antibody Therapy and Targeted Radioimmunotherapy for Untreated Patients With High-Risk B-Cell Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, B-Cell
Keywords: high risk non-hodgkins lymphoma
NHL
Bexxar
high dose chemotherapy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-12-20
Enrollment: 39
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 determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).

Detailed description: This is a phase II efficacy trial for patients with untreated, high-risk, B-cell Non-Hodgkin's Lymphoma. The study will evaluate the efficacy and safety of high-dose chemotherapy combined with monoclonal antibodies and targeted radioimmunotherapy in previously untreated patients with high-risk NHL

Eligibility criteria: Inclusion Criteria:

* Untreated, biopsy proven B-cell non-Hodgkin's lymphoma
* Age \>/= 18 years
* No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for one year. The patient cannot have been exposed to chemotherapy to treat any of these diseases for at least 3 years prior to study entry.
* Meet staging studies and laboratory tests prior to induction, consolidation and radioimmunotherapy.

Exclusion Criteria:

* Significant medical and/or psychiatric illness which may compromise planned treatment;
* Pregnant or lactating;
* HIV-infection.
* Patients with follicular lymphoma grade 1, 2 or 3A are not eligible for this trial.

Primary outcomes:
measure: 1 Year Progression-free Survival Rate
timeFrame: 1 year
Secondary outcomes:
measure: Disease-free Survival
timeFrame: 10 years
measure: Overall Survival
timeFrame: 10 years
measure: Overall Response
timeFrame: up to 1 year
measure: Secondary Malignancies
timeFrame: 10 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Unversity Medical Center
name: David Rizzieri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02695329: Vanguard TKA With KneeAlign 2 and Without KneeAlign 2
Official title: Randomized Controlled Study Comparing Vanguard With KneeAlign2 Navigational System Versus Vanguard Conventional
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: navigation system
palm-sized
total knee arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2016-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments

Detailed description: Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments.

Eligibility criteria: Inclusion Criteria:

* Knee (either unilateral or bilateral) Osteoarthritis (varus deformity only)
* Subjects willing to return for follow-up evaluations

Exclusion Criteria:

* Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis)
* Severe OA deformation (FTA: \>185 degrees or \<175 degrees)
* Active Infection (or within 6 weeks after infection)
* Sepsis
* Osteomyelitis
* Any type of implant is inserted in the affected side of lower extremity
* Hip disease on the affected side
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* diagnosed Osteoporosis or Osteomalacia
* Metabolic disorders which may impair bone formation
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy or neuromuscular disease.

Primary outcomes:
measure: Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia
timeFrame: Postoperative 6 months
Secondary outcomes:
measure: Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold
timeFrame: Postoperative 6 months
measure: Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold
timeFrame: Postoperative 6 months
measure: Number of Participants With Adverse Events and/or Adverse Device Effects
timeFrame: Intra-operative and Post-operative 6 months
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka City University
Study officials:
affiliation: Osaka City University
name: Yukihide Minoda
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01436929: Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs
Official title: Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis
Keywords: silymarin
hepatotoxicity
tuberculosis
HREZ
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 600
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Tuberculosis is a worldwide common infectious disease and effective first line anti-tuberculosis (TB) drugs were available such as isoniazid, rifampicin, ethambutol, and pyrazinamide. However, anti-TB drugs may induce hepatic injury resulting in discontinuation of anti-TB drugs or changing anti-Tb drug regimen.

Silymarin has been widely studied for the effect on hepatitis and it has been used in hepatology.

Therefore, the investigators hypothesized that prophylactic administration of silymarin with anti-TB drugs may decrease the incidence and severity of hepatotoxicity induced by anti-TB drugs.


Eligibility criteria: Inclusion Criteria:

* subjects who are diagnosed with tuberculosis based on microbiological, biomolecular, pathological, or radiographical findings and are expecting to be administered with anti-tuberculosis drugs including INH, RFP, or PZA.
* adults \>=35 years old

Exclusion Criteria:

* basal AST \>40 IU/uL or ALT \>40 IU/uL
* pregnancy
* lactating women
* cases with history of adverse events to silymarin

Primary outcomes:
measure: incidence of hepatotoxicity
timeFrame: 8 weeks
Secondary outcomes:
measure: incidence of hepatotoxicity by genotypic variants
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Deog Kyeom Kim
Study officials:
affiliation: SMG-SNUH Bormae Medical Center
name: Deog Kyeom Kim, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05348629: Efficacy and Safety of Covid-19 Vaccine in Cardiac Patients
Official title: Efficacy and Safety of Covid-19 Vaccine in Cardiac Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Vaccine
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2022-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ages Eligible for Study : 18 Years to 80 Years Genders Eligible for Study : Male or female

Brief summary: Efficacy and safety of covid-19 vaccine in Cardiac patients

Detailed description: investigate the efficacy and safety of covid-19 vaccine in cardiac patients and its possible assocciated morbidity

Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed as STEMI undergo PPCI as (Fourth universal definition of myocardial infarction (2018) Kristian Thygesen) 10
* with age range from 18 to 80 years after 1 month of STEMI .

Exclusion Criteria:

* Patients with previous covid infection confirmed by swap or CT chest or ICU addmision.
* Patients with previous covid infection confirmed by qualitative antibdy test .
* Patients with history of anaphylaxis to any component of the vaccine should not take it .
* patients with febrile illness or acute , ongoing infection .
* immunosuppressive diseases .

Primary outcomes:
measure: all cause mortality
timeFrame: one year
measure: Myocardial infarction
timeFrame: one year
measure: stent thrombosis
timeFrame: one year
Secondary outcomes:
measure: Cardiovascular death. Cardiovascular death. Cardiovascular death.Cardiovascular death. cardiovascular death
timeFrame: one year
measure: heart failure hospitalization
timeFrame: one year
measure: infection by covid-19
timeFrame: one year
measure: anaphylaxis required hospitalization
timeFrame: one year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT04997629: Gene Biobank of Sports Injuries
Official title: Preserve Biological Samples and Gene Extracts of All Sports Medicine-related Diseases. To Study Related Gene Mutation Sites and Regulation. To Study Related Molecular Mechanisms and Signaling Pathways. A Storage Platform for Sports Medicine-related Diseases Research Sample Database Has Been Established.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gene Insertions
Gene Deletion
Keywords: sports medicine
platform
sample database
gene
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients related to sports injuries

Brief summary: Preserve biological samples and gene extracts of all sports medicine-related diseases. To study related gene mutation sites and regulation. To study related molecular mechanisms and signaling pathways. A storage platform for sports medicine-related diseases research sample database has been established.


Eligibility criteria: Inclusion Criteria:

1. Patients with joint sports injuries.
2. Follow-up patients after sports injury.
3. Patients with genetic predisposition to sports injuries.
4. Patients with family genetic predisposition to exercise-related diseases and their relatives.

Exclusion Criteria:

1. Patients with joint damage caused by external force.
2. The patient is accompanied by other injuries at the same time.

Primary outcomes:
measure: Magnetic resonance imaging (MRI)
timeFrame: Before the operation
measure: Magnetic resonance imaging (MRI)
timeFrame: an average of 1 year
measure: Radiographs
timeFrame: Before the operation
measure: Radiographs
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine, Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Lin Lin
role: STUDY_DIRECTOR
References:
Clinical trial NCT05977829: Endometrial Malignancy in Breast Cancer Patients With or Without AUB
Official title: Ultrasonographic, Hysteroscopic, Histopathologic Findings and Risk of Endometrial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Neoplasms
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 283
Sex: FEMALE
Minimum age (years): 43
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing gynecological examinations for endometrial surveillance related to selective estrogen receptor modulators, aromatase inhibitors or other hormone therapy for breast cancer

Brief summary: In order to assess the hysteroscopic, histopathologic, and ultrasonographic aspects of uterine monitoring in postmenopausal breast cancer patients with or without abnormal uterine bleeding (AUB), as well as to calculate the risk of endometrial cancer in women with or without AUB.

Detailed description: 20-25% of postmenopausal women undergoing tamoxifen (TAM) therapy develop polyps, according to recent studies. Many large (\>2 cm) and molecularly changed uterine polyps are usually seen in these women. Furthermore, a number of studies have demonstrated that TAM therapy raises the risk of endometrial cancer in both premenopausal and postmenopausal women. Studies suggest that women who use TAM may also have an increase in the prevalence of uterine sarcomas. In addition, the duration of TAM administration appears to increase the risk of endometrial cancer and uterine sarcoma.

This multicentric cohort study will compare the ultrasonographic, hysteroscopic, and histopathologic findings in postmenopausal women treated for breast cancer with or without AUB in order to increase the robustness of a still ambiguous literature on the subject. It will estimate the risk of endometrial cancer in women with AUB according to various covariates related to the breast neoplasm or the ultrasonographic and hysteroscopic features.

Eligibility criteria: Inclusion Criteria:

* In case of AUB: ultrasonographic endometrial thickness \>5 mm at transvaginal ultrasound
* In case of non-AUB group ultrasonographic suspicion of endometrial or myometrial abnormalities

Exclusion Criteria:

* severe comorbidities (cardiovascular, metabolic, endocrine, and immunological disorders)
* receiving any other form of pharmacologic therapy

Primary outcomes:
measure: Endometrial cancer rate
timeFrame: 1 month after admission
measure: Endometrial hyperplasia rate
timeFrame: 1 month after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: University of Cagliari
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Gaetano Riemma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campania Luigi Vanvitelli
name: Pasquale De Franciscis, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01509729: Topical Lidocaine After Major Arthroscopic Knee Surgery
Official title: Topical Lidocaine Patch Does Not Have an Analgesic Effect After Major Arthroscopic Knee Surgery. A Double-blind Place-controlled Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture of Patella
Pain
Keywords: Knee
Arthroscopy
Lidocaine patch
Pain management after knee arthroscopy
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 21
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: Pain after major arthroscopic surgery is dependent on an optimal multimodal analgesic treatment.

Detailed description: Lidocaine is well-known as analgesic treatment on skin and hypodermic veins. Since 1996 it has been documented that topical lidocaine has an analgesic effect 24 hours after surgical treatment.

The aim is to determine a possible reduction in pain after knee arthroscopy with topical lidocaine.

Eligibility criteria: Inclusion Criteria:

* Patients who were planned for reconstruction of anterior crucial ligament, reconstruction of medial patellofemoral ligament and Elmslie-Trillat procedure for patella instability.
* Patients with synovectomies and menisci resection lasting more than 25 minutes.
* Patients \> 18 years
* Acceptance of informed consent

Exclusion Criteria:

* Patients with rheumatoid arthritis
* Patients with a Body Mass index of \> 35
* Patients who can not read and understand Danish
* Fertile women who does not use secure contraception

Primary outcomes:
measure: Administration of analgesic drugs
timeFrame: 24 hours
Secondary outcomes:
measure: Pain management after surgical treatment
timeFrame: 24 hours
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Orthopaedic Surgery Research Unit, Aarhus University, Aalborg Hospital
Study officials:
affiliation: Orthopaedic Research Unit, Aalborg University Hospital, Denmark
name: Sten Rasmussen, MD
role: STUDY_CHAIR
affiliation: Orthopaedic Research Unit, Aalborg University Hospital, Denmark
name: Marthe Mari O. Bjerke, Stud.med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopaedic Research Unit, Aalborg University Hospital, Denmark
name: Kirstine J. Bennedsgaard, Stud.med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04571229: Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma
Official title: Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Osteosarcoma
Keywords: L-MTP-PE
Expanded Access
20-324
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-09-30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This expanded access protocol will allow access to treatment with L-MTP-PE for people with osteosarcoma. L-MTP-PE is an investigational drug that has not been approved by the FDA to treat any condition, including osteosarcoma. L-MTP-PE works by activating certain types of white blood cells, and these active white blood cells help the immune system kill cancer cells.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of osteosarcoma of any age Note: Patients with either newly diagnosed or relapsed osteosarcoma are eligible.
* Surgical resection or other definitive local control therapy of all clinically detectable sites of osteosarcoma
* L-MTP-PE is deemed to be of potential benefit by the treating investigator
* Willing and able to understand and sign informed consent and assent as appropriate
* Life expectancy \> 6 weeks
* Adequate organ function as follows:
* Adequate bone marrow function defined as:

  * absolute neutrophil count (ANC) ≥ 750/mm\^3
  * platelet count ≥ 30,000/ mm\^3
  * hemoglobin ≥ 8 g/dl
* Adequate renal function defined as:

  * Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min/1.73m\^2 OR
  * Serum creatinine ≤ 2x the upper limit of normal based on age/gender
* Adequate liver function defined as:

  * Bilirubin (sum of conjugated + unconjugated) ≤ 2x upper limit of normal for age or ≤ 4x upper limit of normal if thought to have Gilbert's disease
  * AST or ALT ≤ 3x upper limit of normal or ≤ 5x upper limit of normal for patients with liver metastases
* Willing to use a barrier method of contraception throughout the course of the study and for 1 year after participation if relevant

Exclusion Criteria:

* Use of chronic steroids of other immunosuppressive agents
* Pregnant or breast feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Emily Slotkin, MD
role: PRINCIPAL_INVESTIGATOR
References: