louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02231112: Whole Breast RT on Prone Position in Korean Women
Official title: Feasibility of Prone Position in Postoperative Whole Breast Radiation Therapy in Korean Breast Cancer Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Korean
Left side
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is well known fact that postoperative whole breast radiation therapy (RT) in left breast cancer patient can cause cardiac problem according to the exposed dose. In the several studies in other countries, it was repeatedly showed that RT on prone position can reduce cardiac exposed RT dose in left breast cancer. However, the effectiveness of prone position in RT is not studied in the Korean women have relatively small breast. The investigators planned this study to evaluate the real efficacy of prone position in Korean breast cancer treated with RT.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed left breast cancer
* 20 or older age
* less than 70 years old
* after curative resection
* Eastern Cooperative Oncology Group performance status 0 to 1
* Informed consent to this study
* Consent to contraception for 6 months after RT completion

Exclusion Criteria:

* Male breast cancer
* Combined distant metastasis
* Status of pregnant or brest feeding
* Previous RT history of chest or neck area
* Indication of supraclavicular RT
* Not indicated postoperative whole breast RT

Primary outcomes:
measure: Irradiated cardiac dose
timeFrame: At simulation, expected average of 1 week
Secondary outcomes:
measure: Irradiated dose of left anterior descending artery
timeFrame: At simulation, expected average of 1 week
measure: Irradiated lung dose
timeFrame: At simulation, expected average of 1 week
measure: Clinical target volume (volume, homogeneity index, conformity index)
timeFrame: At simulation, expected average of 1 week
measure: Irradiated dose of axillary lymphatic area
timeFrame: At simulation, expected average of 1 week
measure: Skin change after RT
timeFrame: At 3 months after RT completion
measure: Breast shape after RT
timeFrame: At 6 months after RT completion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00432146: Effect of Lugol's Solution in the Patients With Graves' Disease
Official title: Positive Effect of Lugol's Solution on the Blood Flow and Microvessel Density of Thyroid Gland in the Patients With Graves' Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graves Disease
Keywords: Graves' disease, Lugol's solution
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2007-02-07
Enrollment: 36
Sex: ALL
Minimum age (years): 14
Maximum age (years): 61
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Context: Although some of endocrine surgeons administer Lugol's solution to decrease thyroid gland vascularity, there is still no agreement on its effectiveness.

Objective: The aims of this clinical trial are to evaluate thyroid blood flow and microvessel density in the patients with Graves' disease according to the Lugol's solution treatment preoperatively.

Design: Retrospective clinical trial. Setting: A tertiary referral center. Method: Thirty-six patients were randomly assigned to preoperative medication with Lugol's solution. Patients in group 1 (n=17) received Lugol's solution for 10 days before surgical intervention, whereas patients in group 2 (n=19) didn't receive it.

Main Outcome Measures: Blood flow through the thyroid arteries of patients with Graves' disease was measured by color flow Doppler ultrasonography. The microvessel density (MVD) was assessed immunohistochemically and Western blot analysis using the level of expression of CD-34 in thyroid tissue. The thyroid gland's weight and blood loss were measured in all patients.

Detailed description: Thirty-six patients were randomly assigned to preoperative medication with Lugol's solution. Patients in group 1 (n=17) received Lugol's solution for 10 days before surgical intervention, whereas patients in group 2 (n=19) didn't receive it. Blood flow through the thyroid arteries of patients with Graves' disease was measured by color flow Doppler ultrasonography. The microvessel density (MVD) was assessed immunohistochemically and Western blot analysis using the level of expression of CD-34 in thyroid tissue. The thyroid gland's weight and blood loss were measured in all patients.

Eligibility criteria: Inclusion Criteria:

* Graves disease

Exclusion Criteria:

* Anticoagulant usage,
* Previous thyroid operation,
* Refused to participate in this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University
name: yesim erbil
role: STUDY_DIRECTOR
References:
Clinical trial NCT04187846: Postspinal Headache and Near Infrared Spectroscopy (NIRS)
Official title: Evaluation of the Relationship Between Postspinal Headache and Near Infrared Spectroscopy in Cesarean Section Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tissue Oxygenation
Keywords: Cesarean section
post spinal headache
Near Infrared spectroscopy
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cesarean section under spinal anesthesia

Brief summary: Evaluation of the relationship between postspinal headache and near infrared spectroscopy in cesarean section patients

Detailed description: Patients with cesarean section under spinal anesthesia were included in the study. Before the study, patients were moniterized with NIRS device in the preoperative waiting room.NIRS moniterization was continued intraoperatively at 1st, 4th, 7th, 10th, 15th, 30th minutes and 24th postoperative period.

Patients were divided into two groups as those with postspinal headache (Group A) and those with postspinal headache (Group B). In this study, NIRS values between two groups were compared.

Eligibility criteria: Inclusion Criteria:

* Elective cesarean section

Exclusion Criteria:

* Not willing to participate in the study
* Use of anti-psychotic or anti-depressant drugs
* Patients with headaches

Primary outcomes:
measure: Near Infrared spectroscopy
timeFrame: Up to 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Gaziosmanpasa University
name: Hakan Tapar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01461746: Efficacy Study of Chemotherapy Followed by Radiation Therapy to Treat Endometrial Cancer
Official title: A Phase II Trial of Docetaxel/Cisplatin Chemotherapy Followed by Pelvic Radiation Therapy in Patients, With High-risk Endometrial Carcinoma After Staging Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endometrial Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Boryung Pharmaceutical Co., Ltd
First posted: 2011-10-28
Enrollment: 67
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Previous some studies suggested the addition of chemotherapy to radiation therapy after surgery may have survival benefit in patients with high risk endometrial cancer. In addition, docetaxel plus cisplatin regimen may have similar efficacy with paclitaxel plus carboplatin which is currently used in most cases. However, docetaxel plus cisplatin may cause less toxicity compared to paclitaxel plus carboplatin. Therefore, the investigators aimed to analyze the efficacy of docetaxel plus cisplatin regimen followed by radiation therapy after surgery in patients with high risk endometrial cancer.


Eligibility criteria: Inclusion Criteria:

* One of following high risk groups Stage III after staging operation Stage II (Type I hysterectomy + BSO + LND) Stage I + two of \[Grade III, LVSI+, Mm\>1/2\] Clear cell or serous carcinoma: stage IB-II
* Age: 20-75
* ECOG PS: 0-2
* Adequate organ function BM: WBC ≥ 3,000/mm3, ANC≥1,500/mm3, Plt≥100X103/mm3, Hb≥10.0 g/dl Kidney: Creatinine \<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT\< 3×UNL, T- bil\<1.5 mg/ mm3
* Informed Consent

Exclusion Criteria:

* Previous chemotherapy or pelvic RT
* Hormone therapy within 4 weeks
* Other malignant disease
* Uncontrolled medical disease
* Infection requiring antibiotics
* Symptomatic CHF, RF, Angina, Arrhythmia, etc.
* Neurosis or psychosis
* Etc.

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years after completion of study treatment
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years after completion of study treatment
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Before each chemotherapy, an expected average of 3 weeks
measure: Quality of life
timeFrame: 3 months after completion of study treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Joo-Hyun Nam, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03413046: The Effect of Chemotherapy on Regulatory T Cells
Official title: The Effect of Chemotherapy on Regulatory T Cells in Children With Acute Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre B ALL
Regulatory T Cell
Keywords: Regulatory T cell
Acute lymphoblastic leukemia
Minimal residual disease
Lead sponsor: Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Turkish Society of Hematology
First posted: 2018-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients diagnosed with PreB ALL in a hematology clinic. Healthy children whom are volunraty bone marrow donors.

Brief summary: The investigators aimed to study the effect of chemotherapy on regulatory T cells (Tregs) in children with precursor B (PreB) acute lymphoblastic leukemia (ALL) at 15 and 33 days of malignity directed therapy. The investigators will analyze peripheral and bone marrow blood samples of the participants, obtained at diagnosis, 15 and 33 days of treatment, about Treg / non Treg cells and interleukin (IL)-2, IL-6, IL-10, and transforming growth factor (TGF) beta levels. By this means, investigators will search response to chemotherapy. Also, investigators will analyze correlation between Treg population-Treg related cytokines with demographic, clinical and laboratory findings of the participants with ALL at these certain time points. Additionally, the investigators will compare Treg population and minimal residual disease at 15-33 days of malignity directed therapy. Also investigators will compare these Treg-Treg related cytokines obtained from the participants with ALL and a healthy children control group whom are voluntary donors for bone marrow transplantation.


Eligibility criteria: Inclusion Criteria:

* Children between 1-18 years
* Recent PreB ALL diagnosis

Exclusion Criteria:

* Children under 1 or over 18 years
* Underlying disease e.g. immune deficiency, germline mutations or diseases
* Tcell ALL or acute myeloid leukemia (AML) patients

Primary outcomes:
measure: Change from baseline in number of regulatory T-cells at 15 and 33th day during chemotherapy
timeFrame: Baseline, 15 and 33th day
Secondary outcomes:
measure: Change from baseline IL-2, IL-6, IL-10, and TGF-beta levels at 15 and 33th day during chemotherapy
timeFrame: Baseline, 15 and 33th day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02921646: Relationship Between Evolution of Resting Energy Expenditure and Tumoral Response to Chemotherapy in Patients Suffering From Pancreas Cancer
Official title: Monocentric, Prospective Study Assessing the Feasibility to Use Resting Energy Expenditure by Indirect Calorimetry as Prognostic Marker of Tumoral Response to 1st Line Chemotherapy in Patients Suffering From Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Pancreatic Cancer
Keywords: energetic expenditure
Lead sponsor: Center Eugene Marquis
Sponsor class: OTHER
First posted: 2016-10-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether evolution of resting energetic expenditure is a predictive marker of tumoral response for patients suffering from metastatic pancreatic cancer and treated with 1st line of chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Pancreatic metastatic cancer
* Patient older than 18 years
* Initiation of a first line of chemotherapy by Folfirinox, or Gemcitabine or in combination with Nab-Paclitaxel.
* At least one measurable target lesion
* Patient signed consent for Energie-Pancreas study participation

Exclusion Criteria:

* Other concomitant cancer
* Major general status alteration ( Performance status = 3 or 4 at inclusion)
* Concomitant diseases explaining an altered general status or having an impact on energetic expenditure (i.e.chronic or severe infection, severe cardiac insufficiency, severe respiratory insufficiency, chronic inflammatory disease, recent surgery (\< 1 month), ongoing Healing, hyperthyroidism.
* Smoker
* Patient deprived of his liberty, under guardianship, curator.
* Pregnant patient or breastfeeding
* Claustrophobic patient

Primary outcomes:
measure: Resting energetic expenditure measurement by indirect calorimetry
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Eugène Marquis
Study officials:
affiliation: Centre Eugène Marquis
name: Julien Edeline, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05859646: Effects of Probiotics on Streptococcus Mutans ve Lactobacillus Spp
Official title: Evaluation of Streptococcus Mutans and Lactobacillus Species Due to Probiotic Use in Oral Flora
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Decay
Probiotics
Streptococcus Mutans
Keywords: tooth caries
probiotics
qPCR
Streptococcus mutans
Lactobacillus
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 58
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 separate groups, experimental and control, 6 month follow-up period, randomized distribution
Primary purpose: PREVENTION

Brief summary: To evaluate the change of S. mutans and Lactobacillus spp. counts after all dental treatments were completed under general anesthesia and compare the groups in case of using probiotics and not using probiotics with the time for 6-months follow-up period.

Detailed description: Fifthy-eight pediatric patients without any systemical diseases whose dental treatments were completed under general anesthesia were included in the study. The study was carried out as two-groups; Group A: Patients who started using probiotics after general anesthesia and Group B: Patients who did not use probiotics after general anesthesia. The counts of S. mutans and Lactobacillus spp. were determined by quantitative polymerase chain reaction (qPCR) by analysis of saliva samples taken from all patients on the day before the general anesthesia (T0), at 1-month (T1), 3-month (T2) and 6-month (T3) follow-up periods. The statistical significance level was accepted as p\<0.05.

Eligibility criteria: Inclusion Criteria:

* Every included child had at least 8 tooth with caries.

Exclusion Criteria:

* Patients who would not be able to give saliva samples due to high anxiety or lack of saliva were not included in this study.

Primary outcomes:
measure: S mutans count
timeFrame: 6 month
measure: Lactobacillus spp count
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Başkent University
state: Cankaya
Study officials:
References:
Clinical trial NCT05446246: Superobese Patients
Official title: Predictive Factoris of Failure in Superobese Patients Undergoing Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with BMI \> 35

Brief summary: Super obesity (SO) is defined as a Body Mass Index (BMI) \> 50 kg/m2, and represents the extreme severity of the disease, resulting in an increase in morbidity, mortality, and in poorer quality of life compared with morbid obesity (BMI \> 35 and \<50 kg/m2).


Eligibility criteria: Inclusion Criteria:

* Morbid and superobese patients

Exclusion Criteria:

* Follow up not completed

Primary outcomes:
measure: Surgical success
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: AOU Cagliari
state: CA
Study officials:
References:
Clinical trial NCT00283946: A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia
Official title: FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Initiation and Maintenance Disorders
Sleep Disorders
Keywords: zolpidem
sleep initiation and maintenance disorders Hypnotics and sedatives
double-blind study
comparative study
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-01-31
Enrollment: 876
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of nonorganic insomnia.
* Must be able to swallow tablets

Exclusion Criteria:

* Allergic reactions to zolpidem (Myslee)
* Serious cardiac disorders; Serious hepatic impairment; Serious renal diseases, etc.

Primary outcomes:
measure: Mean wake time after sleep onset during the double-blind period
timeFrame: 2 Weeks
Secondary outcomes:
measure: Mean total sleep time during the double-blind period
timeFrame: 2 Weeks
measure: Mean number of nightly awakenings during the double-blind period
timeFrame: 2 Weeks
measure: Mean sleep latency during the double-blind period
timeFrame: 2 Weeks
measure: Patient impression during the double-blind period
timeFrame: 2 Weeks
measure: Safety
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Chubu region
country: Japan
city: Chugoku region
country: Japan
city: Hokkaido region
country: Japan
city: Kansai region
country: Japan
city: Kanto region
country: Japan
city: Kyushu region
country: Japan
city: Shikoku region
country: Japan
city: Tohoku region
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT00949546: Treatment of Hidradenitis Suppurativa Using Etanercept
Official title: Treatment of Hidradenitis Suppirativa With Etanercept Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hidradenitis Suppurativa
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2009-07-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic HS

Brief summary: Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality of life and allow healing of HS.


Eligibility criteria: Inclusion Criteria:

* Chronic HS for \> 6months defined as tender and/or painful, red nodules and/or plaques (confluent nodules) with or without scarring, foul odor, or draining sinuses clinically with HS
* Localizes to skin folds including any of axillx, breast, abdomen and groin
* active disease
* Negative pregnancy test within 7 days before the first dose of study drug
* Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study

Exclusion Criteria:

* Concurrent active infection including tuberculosis
* Concurrent therapy or therapy 30 days prior with systemic corticosteroids, systemic immunosuppressants, systemic retinoids or ant-TNF agents
* Severe comorbidities (diabetes mellitus requiring insulin, Q F of any severity, MI, unstable angina eectoris, uncontrolled hypertension, oxygendependent severe pulmonary disease, history of cancer \*thin 5_ years except cutaneous basal cell or squamous cell carcinoma or in situ cervical carcinoma, history of TB or TB exposure, chronic hepatitis B or C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy
* Currently enrolled or enrolled within 90 days prior in any trial for treatment of HS
* Known HIV positive
* Contraindication to etanercept as defined in package insert

Primary outcomes:
measure: Physician global assessment of HS of clear or mild at week 12
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: David R Adams, MD, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adams DR, Yankura JA, Fogelberg AC, Anderson BE. Treatment of hidradenitis suppurativa with etanercept injection. Arch Dermatol. 2010 May;146(5):501-4. doi: 10.1001/archdermatol.2010.72.