louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00767052: Investigate the Safety Tolerability and Pharmacokinetics of Multiple Doses of AZD1236
Official title: A Randomised Single Centre Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral Multiple Ascending Daily Doses of AZD1236 Tablet by a Single-Blind, Placebo-Controlled, and Single Dose Relative Bioavailability of the Oral Suspension and Oral Tablet Formulations by an Open Cross-Over in Healthy Japanese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
Safety
Tolerability
Pharmacokinetics
AZD1236
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-06
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of multiple ascending oral doses of AZD1236 given to healthy young subjects for 13 days and to evaluate the single-dose relative bioavailability of the oral suspension and oral tablet formulations.


Eligibility criteria: Inclusion Criteria:

* Provision of signed informed consent prior to any study specific procedures
* Body Mass Index (BMI) between 19-27 kg/m2

Exclusion Criteria:

* Receipt of another investigational drug in the 4 months before dosing in this study
* Acute illness which requires medical intervention within 2 weeks of Visit 2.
* Abnormal resting BP and pulse rate (after resting for 10 minutes). Supine blood pressure \> 140 mmHg systolic or \>90 mmHg diastolic, pulse\<= 50 or =\> 90 beats per minute

Primary outcomes:
measure: Safety and tolerability of AZD1236 by assessment of blood pressure, pulse rate, body temperature, laboratory variables, ECG and adverse events
timeFrame: Assessments taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow up visit. Volunteers will be monitored throughout the study for adverse events.
Secondary outcomes:
measure: Pharmacokinetic profile: concentration of AZD1236 in blood
timeFrame: Samples taken during Visit 2 in multiple dosing part at 41 points and Visit 2/3 in relative bioavailability part at 32 points.
Other outcomes:
Locations:
city: Osaka-city
country: Japan
facility: Research Site
state: Osaka
Study officials:
affiliation: Kyushu Clinical Pharmacology Research Clinic
name: Shunji Matsuki, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05687552: Role of 18F-FDG PET/CT in Gastric Cancer
Official title: Role of 18F-FDG PET/CT in Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient diagnosed by pathology as gastric cancer

Brief summary: The objective of the study is to assess the value of PET/CT in diagnosis, staging, response evaluation, and relapse monitoring of gastric cancer.

Detailed description: gastric cancer (GC) is the fifth most common malignancy and the third leading cause of cancer mortality worldwide (1) It carries a poor prognosis, with a 5-year survival of only 20%-30% (2) Clinical staging, based mainly on imaging, is critical in determining the best treatment.There is a widely accepted consensus of the usefulness of FDG PET/CT in staging and restaging of gastric cancer. According to evidence-based data, this modality can evaluate gastric cancer more accurately and is helpful for evaluation of tumor biologic characteristics, detection of lymph node and distant metastases, assessment of tumor response to therapy(9).

retrospective and prospective study will conducted at Sohag oncology hospital, nuclear medicine unit\& Assuit university hospital, nuclear medicine unit including 50 patients in 12 months .

Eligibility criteria: Inclusion Criteria:

1. patients diagnosed as GC on surgically resected specimens;
2. Patients with gastric and extragastric metastasis.
3. patients with gastric cancer either operated or not.

Exclusion Criteria:

1. Patients with second malignancy.
2. Patient without proven pathology of cancer stomach.
3. Severely ill patient (patient with disturbed conscious level, or couldn't lay supine during the imaging).
4. uncontrolled diabetic patient with blood glucose level more than 200mg\\dl.
5. pregnant women

Primary outcomes:
measure: comparison of pet -ct finding with ct finding
timeFrame: base line
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: wafaa elmaghraby, ass prof
role: STUDY_DIRECTOR
affiliation: Sohag University
name: mohamed soliman, prof
role: STUDY_DIRECTOR
References:
citation: Tang L, Wang XJ, Baba H, Giganti F. Gastric cancer and image-derived quantitative parameters: Part 2-a critical review of DCE-MRI and 18F-FDG PET/CT findings. Eur Radiol. 2020 Jan;30(1):247-260. doi: 10.1007/s00330-019-06370-x. Epub 2019 Aug 7.
citation: Saka M, Katai H, Fukagawa T, Nijjar R, Sano T. Recurrence in early gastric cancer with lymph node metastasis. Gastric Cancer. 2008;11(4):214-8. doi: 10.1007/s10120-008-0485-4. Epub 2009 Jan 8.
citation: Liu Q, Li J, Xin B, Sun Y, Feng D, Fulham MJ, Wang X, Song S. 18F-FDG PET/CT Radiomics for Preoperative Prediction of Lymph Node Metastases and Nodal Staging in Gastric Cancer. Front Oncol. 2021 Sep 13;11:723345. doi: 10.3389/fonc.2021.723345. eCollection 2021.
Clinical trial NCT04748952: Ridge Expansion by Osseodensification
Official title: The Use of Osseodensification for Ridge Expansion and Dental Implant Placement in Narrow Alveolar Ridges: A Prospective Observational Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Horizontal Ridge Deficiency
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults with missing one or more tooth with horizontal alveolar bone defect seeking for dental implant treatment

Brief summary: A prospective observational clinical study guided by the guidelines of Strengthening the Reporting of Observational Studies in Epidemiology (STORBE) in 2014, that conducted to assess amount of ridge expansion obtained by using Dansah burs with simultaneous implant placement.

Detailed description: In this study, 40 implants will be installed in osteotomy sites prepared by Densah burs (osseodensification preparation technique) for patients with horizontal bone deficiency based on radiographic findings (CBCT).

Alveolar ridge width will be measured intraoperatively before and after osteotomy site preparation to assess the amount of ridge expansion. Implant stability will be measured immediately after implant installation and 16 weeks later.

Eligibility criteria: Inclusion criteria

1. Healthy adult patients (≥ 18 years) with American Society of Anesthesiologist physical status classification level I (ASA I), of either gender, having single or multiple missing teeth in the maxilla and/or mandible with alveolar ridge width of 3-6 mm measured at the crest using CBCT.
2. Patients should have ≥ 2 mm of trabecular bone core and ≥ 1/1 trabecular to cortical bone ratio to achieve a predictable expansion according to manufacture instruction in ridge expansion protocol provided by Versah©.
3. Adequate vertical bone height of the alveolar ridge for placement of a minimum length of 8 mm dental implant length based on preoperative OPG or CBCT.
4. Patients who were willing to comply with the study and were available for follow-up visits.

Exclusion Criteria:

- 1. Patients with high bone density (more than 850 HU which corresponds to D1 and D2 according to Misch classification(16)) are not suitable for osseodensification.

2. Patient with severe buccal plate undercut or concavity. 3. Active infection or inflammation in the implant zone. 4. Presence of any uncontrolled systemic diseases. 5. Patients with a history of radiotherapy to the head and neck.

Primary outcomes:
measure: Alveolar ridge width
timeFrame: 0 day
Secondary outcomes:
measure: Implant stability
timeFrame: T0= Primary implant stability measured immediately after implant installation , T1 = secondary implant stability measured after 16 weeks
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of dentistry
Study officials:
References:
Clinical trial NCT02376452: Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients
Official title: Phase II Study of 2-weekly Raltitrexed Plus Irinotecan Regimen (RAILIRI) Versus Fluorouracil, Leucovorin, and Irinotecan Regimen (FOLFIRI) as Second-line Treatment in Advanced Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the efficacy and safety of two-weekly RAILIRI regimen with FOLFIRI regimen in the treatment of advanced colorectal cancer patients in the second-line setting.


Eligibility criteria: Inclusion Criteria:

* aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
* Eastern Cooperative Oncology Group performance status of 0 to 1
* life expectancy of ≥ 3 months
* patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)
* at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
* have adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

* patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
* patients with symptomatic brain metastases
* active clinical severe infection
* previously received irinotecan or raltitrexed
* dihydropyrimidine dehydrogenase (DPD) enzyme adequate

Primary outcomes:
measure: progression free survival
timeFrame: 2 months
Secondary outcomes:
measure: overall survival
timeFrame: 6 months
measure: overall response rate
timeFrame: 2 months
measure: disease control rate
timeFrame: 2 months
measure: Number of Participants with Adverse Events
timeFrame: 2 months
measure: quality of life questionnaire
timeFrame: 2 months
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Medical Oncology, Fudan University Shanghai Cancer Center
name: Wen Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05649852: Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy
Official title: Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy (PASITHEA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy Effect
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2022-12-14
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to assess the average of the "State Anxiety" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion)

Detailed description: As part of this study, patients will be seen 6 times for the purposes of the study: on inclusion, during the first four courses of chemotherapy and at the end of chemotherapy.

The study is offered to the patient during the consultation with the oncologist before the start of chemotherapy. It may possibly be proposed at the latest when he enters hospitalization for chemotherapy.

Two cohorts of patients will be included:

* Patients treated with chemotherapy every 21 days for lung, breast, digestive, colorectal or gynecological cancer;
* Patients treated with chemotherapy every 14 days for digestive or other cancer.

Eligibility criteria: Inclusion Criteria:

* Patient with cancer treated with adjuvant chemotherapy with an interval of 14 or 21 days for the first 3 cycles;
* Chemotherapy naïve patient;
* Patient speaking and understanding French and able to complete the questionnaires;
* Patient having been informed and having signed an informed consent form to participate in the study.

Exclusion Criteria:

* Patient who has already benefited from socio-aesthetic care;
* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
* Patient unable to understand the information related to the study (linguistic, psychological, cognitive reasons, etc.);
* Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.

Primary outcomes:
measure: Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety
timeFrame: Between the inclusion and the end of the third cycle of chemotherapy (maximum cycle of 21 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Valence
country: France
facility: Hôpital Privé Drôme Ardèche
Study officials:
References:
Clinical trial NCT05842252: Single-stage Correction of Acute Angle Coxa Vara
Official title: Single-stage Correction of Acute Angle Coxa Vara
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coxa Vara
Keywords: coxa vara
proximal femur osteotomy
subtrochanteric valgus osteotomy
Wagner technique
tension band wiring.
greater trochanter transfer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 5
Sex: ALL
Minimum age (years): 3
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: greater trochanter transfer and subtrochanteric valgus osteotomy
Primary purpose: TREATMENT

Brief summary: Correction of sever degree of coxa vara in single-stage correction.

Detailed description: The technique described in this article illustrates how to fully correct acute angle developmental coxa vara (neck shaft angle 30 degrees) to obtain better radiological and functional outcomes.

GT transfer Subtroch. valgus osteotomy

Eligibility criteria: Inclusion Criteria:

* acute coxa vara

Exclusion Criteria:

* osteopenic oI

Primary outcomes:
measure: modified McKay's criteria
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: faculty of medicine Assiut university
Study officials:
affiliation: Assiut University
name: Hesaham M Elbaseet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Srisaarn T, Salang K, Klawson B, Vipulakorn K, Chalayon O, Eamsobhana P. Surgical correction of coxa vara: Evaluation of neck shaft angle, Hilgenreiner-epiphyseal angle for indication of recurrence. J Clin Orthop Trauma. 2019 May-Jun;10(3):593-598. doi: 10.1016/j.jcot.2018.06.009. Epub 2018 Jun 28.
citation: Galal S. Percutaneous multiplanar subtrochanteric osteotomy with external fixation for developmental coxa vara (preliminary results). J Pediatr Orthop B. 2017 Jul;26(4):320-328. doi: 10.1097/BPB.0000000000000392.
Clinical trial NCT04036552: The Associations Between Dietary Choline, Genetics and Anxiety/Depression
Official title: The Association Between Dietary Choline, Genetics and Anxiety/Depression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Choline Deficiency
Anxiety
Depression
Lead sponsor: St Mary's University College
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: To be able to detect an association between choline and depression/anxiety required number of participants is 40. However, to reach the adequate balance between groups of people that have the PEMT genetic variant and the ones that do not have it, 80 will be recruited. This is because the PEMT variant of interest is present in 50% of the population

Brief summary: The associations between dietary choline, genetics and anxiety/depression

Detailed description: Choline, previously considered to be a vitamin, is an essential nutrient involved in a plethora of biological pathways. Choline status is thought to be associated with depression and anxiety, however, the lack of evidence regarding the exact mechanism of its action warrants further investigation. This study aims to explore the associations between dietary choline and depression and anxiety in healthy individuals and how these may differ according to genetics, specifically Phosphatidylethanolamine N-Methyltransferase gene involved in endogenous and exogenous choline metabolism. Establishing these associations could reinforce the need for future intervention trials that could in turn establish causality and determine the mechanistic effects of dietary choline and the PEMT gene activity on depression/anxiety

Eligibility criteria: Inclusion Criteria:

* Overall healthy males
* pre-menopausal females of 18-50 years of age.

Exclusion Criteria:

* Individuals with a current clinical diagnosis of anxiety and depression
* pregnant or lactating
* post-menopausal women
* individuals suffering with chronic disease (cardiovascular disease, type-2 diabetes mellitus and cancer)
* individuals using choline, lecithin or soy supplements,
* obese individuals with a Body Mass Index (BMI) \>30 kg/m2.

Primary outcomes:
measure: Depression
timeFrame: 1 day observation
measure: Anxiety
timeFrame: 1 day observation
Secondary outcomes:
measure: Choline intake
timeFrame: 3 day observation
measure: Plasma choline levels
timeFrame: 1 measurement
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's University
Study officials:
References:
Clinical trial NCT00941252: ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial
Official title: Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cervical Intraepithelial Neoplasia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-07-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present primary therapy of cervical intraepithelial neoplasia (CIN) grade 3 and persistent CIN 2 represents conisation. Surgical treatment can cause perioperative (infection, bleeding in in 5-10%) and postoperative (increased risk of preterm labor) complications, as well as incomplete resections (20%) and risk of recurrence in 5-17%. Imiquimod is an immunomodulating drug, that has been reported to be effective in human papilloma virus-related disease, such as vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), and anal intraepithelial neoplasia (AIN). The present randomised, placebo controlled, double blind study evaluates the efficacy of a topical treatment with imiquimod for 16 weeks in 60 patients with histologically confirmed CIN 2/3.


Eligibility criteria: Inclusion Criteria:

* Caucasian women aged 18 years and older with proven HPV-associated CIN 2/3
* Colposcopy with fully visible transformation zone and lesion
* Safe Contraception
* Signed Informed Consent
* Negative urine pregnancy test
* Able to communicate well with the investigator, to understand and comply with the requirements of the study
* Signed the written informed consent

Exclusion Criteria:

* Women who are pregnant or lactating or become pregnant during the conduct of the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* Participating in another clinical trial within 30 days
* Malignancy
* Immunosuppression (medication, illness)
* HIV- or Hepatitis infection

Primary outcomes:
measure: To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3
timeFrame: 20 weeks after treatment start
Secondary outcomes:
measure: HPV-Clearance, feasibility and adverse event profile and drop-out rate
timeFrame: 20 weeks after treatment start
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology
Study officials:
affiliation: Medical University of Vienna
name: Paul Speiser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grimm C, Polterauer S, Natter C, Rahhal J, Hefler L, Tempfer CB, Heinze G, Stary G, Reinthaller A, Speiser P. Treatment of cervical intraepithelial neoplasia with topical imiquimod: a randomized controlled trial. Obstet Gynecol. 2012 Jul;120(1):152-9. doi: 10.1097/AOG.0b013e31825bc6e8.