louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04783948: Validity and Reliability of the Turkish Version of the Pectus Carinatum Evaluation Questionnaire for Patients With Pectus Carinatum
Official title: Validity and Reliability of the Turkish Version of the Pectus Carinatum Evaluation Questionnaire for Patients With Pectus Carinatum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pectus Carinatum
Compliance
Brace
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Pectus Carinatum

Brief summary: Based on the hypothesis that the chest wall was still pliable in adolescence and could be reshaped in a normal position with the external suppressor applied on the chest, a pressure orthosis was started to be used in the pectus carinatum. It is the focus of attention as it is an alternative method to surgery for patients. However, the patient's compliance with the orthosis is difficult. Therefore, in our study, we aimed to investigate the Turkish Validity and Reliability of the Pectus Carinatum Evaluation Questionnaire, which is a questionnaire investigating the compliance with orthosis treatment in patients diagnosed with Pectus Carinatum by the doctor.


Eligibility criteria: Inclusion Criteria:

1. Patients who have been diagnosed with Pectus Carinatum by a doctor, have an orthosis indication (2 cm above the protrusion level) and who are given the orthosis for the first time
2. Having a correction pressure below 10 pounds per square inch (PSI) in the compression test
3. Between the ages of 10-18,
4. Having dissatisfaction with this defect

Exclusion Criteria:

1. Having severe scoliosis (Cobb angle over 20 degrees)
2. Having chronic systemic disease
3. Having a serious psychiatric illness
4. Having complex mixed type pectus deformity

Primary outcomes:
measure: Pectus Carinatum Evaluation Questionnaire
timeFrame: 15-21 days
Secondary outcomes:
measure: The Pectus Excavatum Evaluation Questionnaire
timeFrame: 15-21 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem University
Study officials:
References:
Clinical trial NCT04956848: Comparing KIDScore™ D5 and iDAScore®. The KiDA Study
Official title: A Comparison of Two Models Used for Identifying Embryos With the Best Chance of Inducing Pregnancy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IVF
Infertility
Keywords: Embryos
Embryo scoring
Blastocyst selection
Pregnancy rate
Live birth rate
Lead sponsor: Vitrolife
Sponsor class: INDUSTRY
First posted: 2021-07-09
Enrollment: 165
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot study randomizing embryos into two study groups comparing two decision support tools in the ranking of embryos for transfer.
Primary purpose: TREATMENT

Brief summary: A pilot study to gather information on clinical pregnancy rates for preparation of the planning of a larger randomized controlled trial comparing two decision support tools: the deep learning tool iDAScore® and the current annotation model, KIDScore™ D5.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing IVF/ICSI-treatment with controlled ovarian stimulation with gonadotrophins and the intention to treat by transfer of a single day 5 fresh blastocyst on day 5.
2. At least two good quality blastocysts (GQB) on day 5 (3BB or better on the Gardner scale), originating from normally fertilized oocytes (2PN).

Exclusion Criteria:

1. Previous participation in this RCT
2. Concurrent participation in another investigation
3. Intention to perform any form of preimplantation genetic testing
4. Fertility preservation
5. Planned transfer on day 2-4
6. Female age \>42 years
7. A reduced likelihood of obtaining two good quality blastocysts on day 5 as evidenced by an AFC \<5 (if available, AFC=antral follicle count)

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: After 6 weeks of gestation
Secondary outcomes:
measure: Positive hCG rate per randomized patient
timeFrame: From day 13 following embryo transfer
measure: Rate of non-viable intrauterine pregnancies per randomized patient
timeFrame: After 6 weeks of gestation
measure: Clinical pregnancy rate in patients with maternal age above 35
timeFrame: After 6 weeks of gestation
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Göteborgs IVF klinik
city: Örebro
country: Sweden
facility: Fertilitetsenheten, Universitetssjukhuset Örebro
Study officials:
affiliation: Göteborgs IVF klinik
name: Johanna Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01679548: Study of Laparoendoscopic Single Site Hysterectomy in Benign and Preinvasive Uterine Disease
Official title: Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Assisted Vaginal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign or Preinvasive Uterine Disease
Keywords: LESS
Benign uterine disease
LAVH
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 424
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy between single-port and three-port laparoscopic assisted vaginal hysterectomy in patients with benign or preinvasive uterine disease

Detailed description: This study intended to conduct a randomized trial to determine whether LESS LAVH has a faster recovery rate than three-port LAVH.

Eligibility criteria: Inclusion Criteria:

* Patient who undergo laparoscopic assisted vaginal hysterectomy due to following gynecologic disease

  1. uterine leiomyoma
  2. uterine adenomyosis
  3. Endometrial hyperplasia
  4. cervical intraepithelial neoplasia including carcinoma in situ
  5. Dysfunctional uterine bleeding
  6. Other benign gynecologic disease requiring hysterectomy
* American Society of Anesthesiologists Physical Status classification I-II
* Patient who have signed an written informed consent

Exclusion Criteria:

* Uncontrolled medical disease
* Active infectious disease
* Previous pelvic radiation therapy
* Patient who requiring further procedure excluding hysterectomy, unilateral or bilateral salpingooophorectomy / salpingectomy / oophorectomy
* Patient who undergoes subtotal hysterectomy
* Patient who have other pain source excluding gynecologic disease
* Pregnancy and lactating woman

Primary outcomes:
measure: postoperative hospital stay
timeFrame: within 1 week after surgery
Secondary outcomes:
measure: postoperative pain
timeFrame: within 1 week after surgery
measure: postoperative analgesics requirement
timeFrame: within 1 week after surgery
measure: operating time
timeFrame: 1 day (immediately ater surgery)
measure: Transfusion requirement and amount
timeFrame: within 1 week after surgery
measure: intra and postoperative complication
timeFrame: within 1 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Joo-Hyun Nam, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04240548: Radiation Therapy for ypN0 Breast Cancer
Official title: Role of Regional Nodal Irradiation in Node Positive Breast Cancer Patients With ypN0 After Preoperative Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: breast cancer
regional nodal irradiation
preoperative chemotherapy
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 160
Sex: FEMALE
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 is a phase III randomized study comparing regional nodal irradiation vs. no irradiation for breast cancer patients presenting with node positive disease who turns into node negative after preoperative chemotherapy


Eligibility criteria: Inclusion Criteria:

* WHO performance status 0-1
* Invasive Breast Cancer with cT1-3 cN1-2 at time of diagnosis
* Axillary nodal involvement can be detected using, clinical examination, ultrasound, CT scan or PET scan
* Pathologic confirmation using, FNAC, core biopsy or excisional biopsy
* ER, PR, Her2 neu and Ki67 status should be available for all patients
* All patients should have received standard preoperative chemotherapy prior to surgery
* At the time of surgery, all patients should have axillary clearance with at least 6 nodes harvested from the axilla
* Patients who have undergone mastectomy or lumpectomy with negative margins with ypN0, ypN0(+i) or ypN0(+mol) are eligible for randomization

Exclusion Criteria:

* Poor performance status
* Definitive clinical or radiologic evidence of metastatic disease
* T4 tumors including inflammatory breast cancer
* N3 disease detected clinically or by imaging
* Patients with histologically positive axillary nodes after preoperative chemotherapy
* Positive surgical margin after definitive surgery
* Previous ipsilateral or contralateral breast cancer
* Previous chest wall or breast irradiation
* Second primary cancer
* Active connective tissue disease

Primary outcomes:
measure: Regional Nodal Failure ( axillary, internal mammary or supraclavicular recurrences )
timeFrame: time from randomization till supraclavicular, axillary or internal mammary recurrence, assessed up to 10 years
Secondary outcomes:
measure: Disease Free survival
timeFrame: Time from randomization until local, regional or distant recurrence, assessed up to 10 years
measure: Overall Survival
timeFrame: from randomization till death from any cause, assessed up to 10 years
measure: Local Failure
timeFrame: from time of randomization until chest wall recurrence post mastectomy or In Breast Tumor Recurrence post lumpectomy, assessed up to 10 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
References:
Clinical trial NCT00885248: Integrated Positron Emission Tomography - Computed Tomography (PET-CT) in Patients With Pancreatic Cancer
Official title: Clinical Implication of Integrated PET-CT in the Patients With Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
integrated PET-CT
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2009-04-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The suspects of pancreatic cancer to visit Asan Medical Center in South Korea

Brief summary: In suspecting pancreatic cancer, dynamic phase pancreatic CT is the most effective tool in diagnosis and staging. In addition, magnetic resolution image, endoscopic ultrasonography, endoscopic retrograde pancreatography, angiography can be performed.

After introduction of functional image, PET has been suggested in the role of diagnosis and staging of pancreatic cancer. Furthermore, recently fused images of PET and CT were available.

In this study, the researchers evaluate the role of integrated PET-CT in patients with pancreatic cancer and analysis the cost-effectiveness of the integrated PET-CT.

Detailed description: Compared to dynamic phase pancreatic CT, integrated PET-CT will be evaluated for sensitivity, specificity and accuracy of diagnosing and staging pancreatic cancer while the gold standard for pancratic cancer is operative specimen. If the operation can't be performed, EUS-FNA of the pancreatic mass or lymph node and additional imaging modality will be preferred to laparotomy.

Eligibility criteria: Inclusion Criteria:

* Pancreatic mass suspicious of pancreatic cancer
* No comorbidity, expected life expectancy less than 6 months
* Consent this study in letter

Exclusion Criteria:

* Refuse diagnostic and staging work-up

Primary outcomes:
measure: Staging of pancreatic cancer
timeFrame: 6 months after study start
Secondary outcomes:
measure: Diagnosis of pancreatic cancer
timeFrame: 6 months after study start
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT01738048: Persistent Pain After Reconstruction Following Mastectomy
Official title: Persistent Pain After Reconstruction Following Mastectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Chronic Pain
Keywords: Pain
Neuropathic pain
Chronic pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Breast Cancer Cooperative Group
First posted: 2012-11-30
Enrollment: 1352
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Nationwide cross-sectional cohort

Brief summary: A cross sectional study to determine the prevalence of persistent pain after reconstructive surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated with mastectomy without reconstruction.

Detailed description: The aim of the study is to determine if reconstruction of the breast after mastectomy increases the risk of reporting persistent pain 2-3 years after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with unilateral primary breast cancer aged 18-70 years

Exclusion Criteria:

* recurrent cancer
* other malignancy
* emigration
* non-standardized treatment

Primary outcomes:
measure: The risk of developing persistent if reconstructed
timeFrame: Cross-sectional, 2-3 years after surgery for breast cancer
Secondary outcomes:
measure: Prevalence of persistent pain after reconstruction after mastectomy
timeFrame: Cross-sectional, 2-3 years after surgery for breast cancer
measure: Prevalence of sensory disturbances after reconstruction after mastectomy
timeFrame: Cross-sectional, 2-3 years after surgery for breast cancer
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, University of Copenhagen
name: Kenneth G Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.
Clinical trial NCT03043248: TRK-700 Drug-Drug Interaction Study With Digoxin and Midazolam
Official title: TRK-700 Drug-Drug Interaction Study With Digoxin and Midazolam in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: TRK-700
PK
Digoxin
Midazolam
Drug-Drug interaction
P-glycoprotein
CYP3A4
MDR1
pharmacokinetics
multidrug resistance 1
Lead sponsor: Toray Industries, Inc
Sponsor class: INDUSTRY
First posted: 2017-02-03
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study comprises 2 cohorts, and in each cohort, the study will be conducted as an open-label add-on study.

The purpose of the study is to investigate the pharmacokinetics of each substrate in concomitant administration of a single dose of the P-glycoprotein substrate digoxin (Cohort A) or the CYP3A4 substrate midazolam (Cohort B) during repeated administration of TRK-700 in healthy adult males.


Eligibility criteria: Inclusion Criteria:

* Japanese healthy adult males.
* Subjects with a BMI of at least 18.0 and less than 30.0 at the screening examination and the examination at admission.

Exclusion Criteria:

* Subjects with significant concomitant or historical disease of the metabolism, liver, kidneys, blood, lungs, heart, digestive organs, urinary organs, or nerves, or psychiatric diseases, accompanied by clinical symptoms or with other clinically significant disease, who are unsuitable for participation in this study, in the opinion of the investigators.
* Subjects who are found by the investigators to have significant clinical abnormality at the screening examination, the examination at admission, or the examination at the day of first administration of Digoxin or Midazolam.

Primary outcomes:
measure: Area under the plasma drug concentration - time curve from administration to the last available concentration measurement of Digoxin and Midazolam(AUClast)
timeFrame: Cohort A: up to 72 hours, Cohort B: up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Tokyo
Study officials:
References:
Clinical trial NCT00716248: Bucillamine Study of Holding Remission After Infliximab Dose-off
Official title: The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Saitama Medical University
Sponsor class: OTHER
Collaborators: name: Keio University
First posted: 2008-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with rheumatoid arthritis who have been well controlled with methotrexate plus infliximab may remain in remission or low disease activity without infliximab. And the chance of sustained remission increase by the addition of another DMARD, bucillamine, at the time of discontinuing infliximab. The BuSHIDO trial is the prospective, randomized, controlled study comparing MTX monotherapy and MTX plus bucillamine combination therapy as to the rate of disease flare after discontinuing infliximab.


Eligibility criteria: Inclusion Criteria:

* RA according to American College of Radiology (ACR) classification criteria
* Age of 20 or greater
* DAS28-ESR \< 3.2 or DAS28-CRP \< 2.6 for more than 6 months

Exclusion Criteria:

* Previously teated with bucillamine
* Pregnancy or lactation

Primary outcomes:
measure: The rate of disease flare
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kawagoe
country: Japan
facility: Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University
state: Saitama
Study officials:
References:
Clinical trial NCT02419248: Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation
Official title: Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Irritability
Lead sponsor: Kley Hertz S/A
Sponsor class: INDUSTRY
First posted: 2015-04-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with age from 18 to 70 years old, with skin color varying between clear caucasian to dark.

Brief summary: Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa.


Eligibility criteria: Inclusion Criteria:

* Age between 18 to 70 years old;
* Skin types: I (light caucasian), II (caucasian), III (light dark) and IV (dark)
* intact skin where the product will be applied
* Agreement to comply with the test procedures and attend the clinic in the days and ixed times for medical assessments and application and reading of dressings
* Signature of informed consent form

Exclusion Criteria:

* Pregnancy and lactation
* Use of anti-inflammatory and immunosuppressive drugs from 30 days up to three months prior to selection;
* Diseases that cause immune suppression;
* Personal history of atopy;
* History of sensitisation and irritability to topical products;
* Active cutaneous pathologies (local and / or scattered) that may interfere in the study results;
* Use of new drugs and/or cosmetics during the experiment;
* Skin reactivity;
* Previous participation in a study with the same product under test;
* Volunteers who have congenital or acquired known immunodeficiency;
* Relevant medical history or current evidence of alcohol or other drugs abuse;
* Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator);
* Sponsor's employees involved in the study, or close family member of an employee involved in the study;

Primary outcomes:
measure: Evaluation of adverse effects in maximized conditions
timeFrame: 40 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05573048: A Study of Optical Fusion Trans-Perineal Grid
Official title: Optical Fusion Trans-Perineal Grid
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Prostate Biopsy
Keywords: Prostate Ablation Procedure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Clear Guide Medical Inc.
First posted: 2022-10-10
Enrollment: 20
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this research is to evaluate a new needle guide grid utilizing Clear Guide SCENERGY - MR with a grid embedded with VisiMARKER II to autoregister and target the prostate aiding in needle placement positioning. The proceduralist can utilize this technology to find the best needle path to target within the pelvis.


Eligibility criteria: Inclusion Criteria:

* Scheduled for a MR guided biopsy or ablation.
* One, two, or three tumor suspicious regions identified on multiparametric MRI.
* Tolerance for anesthesia/sedation.
* Ability to give informed consent.

Exclusion Criteria:

* Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
* History of other primary non-skin malignancy within previous three years.

Primary outcomes:
measure: Needle placement accuracy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Woodrum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: