louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00152919: Mobicox: Study of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy
Official title: A Comparison of 2 Schedules of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy - A Randomized Phase III Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-09-09
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Swelling of the prostate can occur during and after a brachytherapy. This swelling can cause urinary problems ranging from difficulty voiding to urinary retention. The purpose of this study is to investigate whether Mobicox started one week before brachytherapy and then continued afterwards is more effective in reducing the risk of needing a catheter than Mobicox given only afterwards.


Eligibility criteria: Inclusion Criteria:

* Eligible to receive prostate brachytherapy as per the Ontario Provincial Guidelines will be eligible for this study (i.e. prostate specific antigen \[PSA\] \< 10, Gleason score \<7, Stage \<= T2a)

Exclusion Criteria:

* Patients already taking anti-inflammatory drugs
* Patients with allergic-type reactions, including asthma and urticaria, to aspirin or nonsteroidal anti-inflammatory agents (see product information)

Primary outcomes:
measure: To compare 2 schedules of MeloxicamTM given in the peri-operative period to reduce prostate swelling after permanent seed implantation for prostate cancer
Secondary outcomes:
measure: To determine the influence of different timing of MeloxicamTM administration on urinary toxicity and biochemical response after permanent seed implantation for prostate cancer
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Juanita Crook, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crook J, Patil N, Wallace K, Borg J, Zhou D, Ma C, Pond G. A phase III randomized trial of the timing of meloxicam with iodine-125 prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):496-501. doi: 10.1016/j.ijrobp.2009.04.078. Epub 2010 Mar 28.
Clinical trial NCT04810819: Clinical Study of the Effect of Methylprednisolone Combined
Official title: Clinical Study of the Effect of Methylprednisolone Combined With Two Hydroxypropyl Theophylline on Respiratory Dynamics During Thoracoscopic Lobectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Methylprednisolone;Dihydroxypropyltheophylline;One Lung Ventilation;Respiratory Dynamics
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Through the design of RCT study, the preoperative use of drugs (methylprednisolone + dihydroxypropyltheophylline) as intervention measures, the patients undergoing thoracoscopic lobectomy as the main research object, through the comparison of two groups of patients with intraoperative respiratory dynamics index and postoperative complications, to explore a more effective perioperative management method.


Eligibility criteria: Inclusion Criteria:

* 1. After fully understanding the purpose and significance of the trial, the patients voluntarily participated in the trial and signed the informed consent;

  2. The type of operation was general anesthesia and thoracoscopic lobectomy;

  3. Age 18-75 years old, including boundary value, gender is not limited;

  4. BMI 18-26kg / m2;

  5. ASA grade I-II; no mental disorder, normal consciousness, normal communication;

  6. No contraindications of methylprednisolone and dihydroxypropyltheophylline.

Exclusion Criteria:

* 1. There were diseases of immune, endocrine, nervous and mental system before operation, and serious dysfunction of heart, liver and kidney;

  2. Take immunosuppressive drugs and non steroidal anti-inflammatory drugs before operation;

  3. Respiratory tract infection (cough, expectoration, suffocation, etc.) in recent 1 month; pneumonia, bronchitis, etc. on CT;

  4. History of chronic pulmonary disease, including but not limited to asthma, pulmonary abscess, tuberculosis, chronic bronchitis, etc;

  5. FEV1 \< 50%;

  6. Oxygen saturation was lower than 90% and airway pressure was higher than 40 cm H20;

  7. Continuous hypotension or hypertension during the operation; intraoperative blood loss \> 1000ml;

  8. Allergic to methylprednisolone or dihydroxypropyltheophylline;

  9. There are any other situations that the researchers think are not suitable for inclusion.

Primary outcomes:
measure: Pplat
timeFrame: 5 different time points during the operation
measure: Ppeak
timeFrame: 5 different time points during the operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04792619: The Effect of Scapular Exercises in Patients With Stroke
Official title: The Effect of Scapular Exercises on Trunk Control in Patients With Stroke: A Double-blind Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a paucity of research on the correlation between postural control and upper extremity function. Analyzing the mechanisms of postural deficits and related problems is believed to give idea for any conceivable advance in future rehabilitation strategies in patients with stroke.

The purpose of this study was to examine the effect of scapular exercises on the scapular stability and trunk control. We hypothesized that scapular exercises correct the scapular position and improve postural control. Hence the reaching out movement can be applied in a controlled and fluent manner at the end of the treatment.


Eligibility criteria: Inclusion Criteria:

Diagnosed as acute stroke, being able to sit without support, presence of hemiparesis, clinical stability

Exclusion Criteria:

Shoulder joint dysfunction due to previous musculoskeletal disease, severe dementia, severe visual disturbances that could not be corrected with glasses, severe aphasia, scored ≥ 3 on the Modified Ashworth Scale and refused to participate

Primary outcomes:
measure: Scapular mobility
timeFrame: 12 months
measure: Trunk Impairment Scale
timeFrame: 12 months
measure: Trunk Control Test
timeFrame: 12 months
measure: Modified Barthel Index
timeFrame: 12 months
measure: Reaching Performance Test
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Mehmet Duray
Study officials:
References:
Clinical trial NCT01953419: Phase II Study of Pemetrexed in Advanced or Recurrent Gastric Cancer After Chemotherapy
Official title: Pemetrexed for Previously Treated Patients With Metastatic Gastric Cancer: a Prospective Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial aimed to assess the efficacy and safety of pemetrexed in patients with pretreated metastatic gastric cancer.

Detailed description: Patients enrolled in this study received pemetrexed 500mg/m2, once every 21 days, until the presence of progressive disease or unacceptable toxicity. All patients took dexamethasone 3.75 mg twice daily, starting from the day before and continuing to the day after the drug administration. Patients were instructed to take oral folic acid 400 mg daily beginning 5 days before the first therapy and until the final therapy.Patients received Vitamin B12 very 3 cycle of chemoherapy. Granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) or Erythropoietin (EPO) was not allowed, but they could be used when the patients suffered from bone marrow depression.

Eligibility criteria: Inclusion Criteria:

1. histological confirmed inoperable or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
2. age between 18 and 80 years
3. ECOG performance status of 0 to 2
4. life expectancy ≥ 12 weeks
5. has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
6. at least one prior chemotherapy regimen
7. adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3
8. platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL
9. adequate renal function defined by creatinine less than or equal to 1.25 × upper limit of normal(ULN) and creatinine clearance more than or equal to 60mL/min,
10. adequate liver function defined by bilirubin less than or equal to 1.0×ULN aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 2.5 ×ULN.

Exclusion Criteria:

1. other primary malignancy
2. symptomatic central nervous system metastasis
3. pregnancy or lactation
4. cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure
5. ongoing infection
6. inability or unwillingness to interrupt nonsteroidal anti-inflammatory drugs for 2 days before and after pemetrexed administration unwillingness to take folic acid or vitamin B12 supplementation.

Primary outcomes:
measure: ORR
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen UniversityCancer center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: RH Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05378919: Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer
Official title: Evaluation and Comparison of the Efficacy of a New Standard Pre-operative Chemotherapy for Stage II and III Colorectal Cancer According to the FOLFOX4 Regimen With Routine Chemoradiation Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 250
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: Phase II, Multicenter, Open-label, Randomized Study evaluating neoadjuvant chemotherapy (FOLFOX4) in patients with stage II and III colorectal cancer with standard chemoradiation Defined by Magnetic Resonance Imaging

Detailed description: This is a biomedical research, phase II, multicenter, open-label, randomized study, comparing neoadjuvant CT with FOLFOX4, versus immediate preoperative chemoradiotherapy (CRT), in patients with locally advanced rectal cancer. Randomization in a 1: 1 ratio, neoadjuvant chemotherapy or chemoradiation. The purpose of the study is to evaluate the efficacy, tolerability, and comparability of new standard preoperative chemotherapy with FOLFOX4 in patients with stage II and III colorectal cancer compared to routine chemoradiation.

Eligibility criteria: Inclusion Criteria:

* diagnosed with rectal adenocarcinoma;
* radiologically measurable tumor size;
* general condition (ECOG 0-2 points);
* stage II or III rectal tumor clinically (pelvic MRI and endorectal ultrasound),
* in the absence of long-term spread of the disease (confirmed by radiological examinations (computed tomography of the thorax and abdomen));
* during preoperative proctoscopy, the tumor is detected 0 -15 cm from the anus;
* Blood tests 28 days before the start of treatment:

and general blood count: neutrophils greater than 1.5x10 9 / l, platelets greater than 100 x 10 9 / l, Hemoglobin greater than 80 g / l, liver enzymes (Aspartate aminotransferase (AST/GOT), alanine aminotransferase (ALT/GPT) not more than 3 times upper limit), and renal function (creatinine up to 1.5 times the upper limit of normal) is normal; women of childbearing potential - negative pregnancy test;

• A signed informed consent form.

Exclusion Criteria:

* patients with signs of intestinal obstruction at the start of treatment;
* previous lower abdominal radiation therapy;
* other tumors over a five-year period;
* pregnant or breastfeeding women;
* men and women of childbearing potential who do not agree to use adequate contraception;
* Patient co-morbidities that would make the patient unsuitable for this study or significantly interfere with the assessment of safety and toxicity.

Primary outcomes:
measure: disease-free survival
timeFrame: 3 year
Secondary outcomes:
measure: Overall survival
timeFrame: 7 year
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Rita Ambraziene
Study officials:
References:
Clinical trial NCT06188819: Rolled Pericardium Versus Cryopreserved Allograft to Treat Native or Prosthetic Aortic Infection
Official title: Rolled Pericardium Versus Cryopreserved Allograft to Treat Native or Prosthetic Aortic Infection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Infections and Inflammations
Lead sponsor: University Paul Sabatier of Toulouse
Sponsor class: OTHER
Collaborators: name: LUCAS BATISTELLA, MD
name: Kheira hireche, MD
name: Ludovic CANAUD, MD PhD
First posted: 2024-01-03
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients operated on for a native infection or an aortic prosthesis who had pericardium or allograft reconstruction

Brief summary: While surgery with anatomic reconstruction of prosthetic aortic infections and native infectious aortitis has become established over time, the ideal substitute is not clearly defined. The cryopreserved arterial allograft (AAC) recognized as resistant to infections not only presents availability problems making its use complicated, particularly in emergencies, with a certain number of long-term aneurysmal developments. The tubulized pericardium patch (PP), available in all cases, seems to give promising results in recent literature. The investigators propose a comparative study of these two substitutes in this indication.

We carried out a two-center observational study including retrospectively from January 2010 to July 2023 all patients operated on for aortic prosthesis infection and native infectious aortitis with AAC reconstruction and prospectively PP patch reconstructions from July 2018 to July 2023. The diagnosis of infection was established according to the MAGIC criteria. The patients' preoperative comorbidities were collected to compare the groups. Postoperative morbidity and mortality was then compared. The medium-term evaluation consisted of comparing according to the Kaplan Meier method: postoperative mortality, permeability, reinfection rate, reoperation rate.


Eligibility criteria: Inclusion Criteria:

* All aortic intervention performed for native aortic infection reconstruction with patch or allograft
* All aortic intervention performed for infected graft reconstruction with patch or allograft

Exclusion Criteria:

* no

Primary outcomes:
measure: Mortality
timeFrame: day 30 post operative
measure: Reintervention
timeFrame: 30 days, 6 months, 12 months, 24 months
measure: Post operative Major cardiovascular adverse events (MACE)
timeFrame: day 30 post operative
Secondary outcomes:
measure: Permeability
timeFrame: 30 days, 6 months, 12 months, 24 months
measure: Reinfection
timeFrame: 30 days, 6 months, 12 months, 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06897319: High-Flow Tracheal Therapy on Tracheobronchial Secretions in Tracheostomized Patients
Official title: Impact of High-Flow Tracheal Therapy on the Rheological Properties of Tracheobronchial Secretions in Tracheostomized Patients: A Randomized Crossover Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tracheostomized Patients
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This monocentric, randomized crossover study aims to assess the impact of high-flow tracheal therapy (HFT) on the rheological properties of tracheobronchopulmonary secretions in tracheostomized patients. The primary objective is to compare the viscoelastic characteristics of secretions collected with and without HFT. Secondary objectives include evaluating the effects of HFT on dyspnea, patient comfort, and secretion appearance. The study will take place at Cliniques Universitaires Saint-Luc, with adult tracheostomized patients undergoing standard care.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years old)
* Tracheostomized patients
* Patients requiring routine tracheal suctioning and already using HFT overnight

Exclusion Criteria:

* Insufficient secretions for analysis
* Cognitive impairment or confusion

Primary outcomes:
measure: Critical stress (σc)
timeFrame: Measured three times: at baseline, after one hour, after 4 hours
Secondary outcomes:
measure: Dyspnea (modified Borg scale)
timeFrame: Measured two times: at baseline and after 4 hours
measure: Patient Comfort (Visual Analog Scale - VAS)
timeFrame: Measured two times: at baseline and after 4 hours
measure: Secretion Appearance (Murray Scale)
timeFrame: Measured two times: at baseline and after 4 hours
measure: Viscoelastic modulus (G*)
timeFrame: Measured three times: at baseline, after one hour, after 4 hours
measure: Damping ratio (tan δ)
timeFrame: Measured three times: at baseline, after one hour, after 4 hours
measure: Critical strain (γc)
timeFrame: Measured three times: at baseline, after one hour, after 4 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT07006519: The Prevalence of Incisal Angle of Maxillary Central Incisors in Adults
Official title: The Prevalence of Incisal Angle of Maxillary Central Incisors in Adults: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anterior Teeth
Keywords: anterior teeth
central incisor
Lead sponsor: Misr International University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult individuals with sound central incisor

Brief summary: This study is to assess the prevalence of different incisal angle of maxillary central incisors in a sample of adults.Materials and methods: The current study will include 300 sound natural maxillary central incisor. intraoral scan will be taken for all cases to measure the incisal angle.

Detailed description: This study is aimed to assess the prevalence of different incisal angle of maxillary central incisors in a sample of adults population with sound anterior central incisors. The current study will include 300 sound natural maxillary central incisor. For each, an intraoral scan will be taken to measure the incisal angle. , wither having a mesial or distal incisal angle and its degree and how frequent each one. the scans will be aligned in same xyz axis for proper standardization for the measurements.

Eligibility criteria: Inclusion Criteria:

* sound natural teeth

Exclusion Criteria:

* rotated teeth
* pathological migration of teeth
* patients subjected to trauma for anterior teeth

Primary outcomes:
measure: Incisal angle
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: International Dental Clinic Educational centre
city: Cairo
country: Egypt
facility: International Dental Clinic Educational centre
Study officials:
References:
Clinical trial NCT01599819: BAX 855 Dose-Escalation Safety Study
Official title: BAX 855 (PEGylated Recombinant Factor VIII): A Phase 1, Prospective, Open Label, Cross-Over, Dose-Escalation Study in Previously Treated Patients (PTPs) With Severe (FVIII < 1%) Hemophilia A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemophilia A
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Baxter Innovations GmbH
First posted: 2012-05-16
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE, and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.


Eligibility criteria: Inclusion Criteria:

* The subject is male and is 18 to 65 years of age at the time of screening
* The subject has severe hemophilia A (factor VIII level \< 1%)
* The subject was previously treated with plasma-derived factor VIII (FVIII) concentrates or recombinant FVIII for at least 150 exposure days (EDs)

Exclusion Criteria:

* The subject has a detectable FVIII inhibitor at screening, with a titer \>= 0.6 BU
* The subject has a documented history of FVIII inhibitors with a titer \>= 0.4 BU at any time prior to screening
* The subject has a known hypersensitivity towards mouse or hamster proteins or to polyethylene glycol (PEG)

Primary outcomes:
measure: Serious and non-serious AEs
timeFrame: 4 weeks after infusion with BAX 855 and ADVATE
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment "Joan Pavel"
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain, Hemophilia Care Center for Children and Adults
city: Giessen
country: Germany
facility: UKGM Uniklinikum Giessen & Marburg
city: Munich
country: Germany
facility: Harrison Clinical Research Deutschland
city: Nara
country: Japan
facility: Nara Medical University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: London
country: United Kingdom
facility: Quintiles Drug Research Unit at Guy´s Hospital
city: Manchester
country: United Kingdom
facility: Manchester Haemophilia Comprehensive Care Centre, Manchester Royal Infirmary
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Konkle BA, Stasyshyn O, Chowdary P, Bevan DH, Mant T, Shima M, Engl W, Dyck-Jones J, Fuerlinger M, Patrone L, Ewenstein B, Abbuehl B. Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A. Blood. 2015 Aug 27;126(9):1078-85. doi: 10.1182/blood-2015-03-630897. Epub 2015 Jul 8.