louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03777202: Efficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea
Official title: Efficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the utility of high-flow nasal oxygen during sleep endoscopy in obstructive sleep apnea patients.


Eligibility criteria: Inclusion Criteria:

* adult patients aged over 19 years who are scheduled for sleep endoscopy

Exclusion Criteria:

* 1) basal skull fracture, 2) facial anomaly, 3) consciousness disorder, 4) Risk of aspiration, 5) necessity of awake fiberoptic intubation due to the large vocal cord mass, endotracheal tumor or bleeding.

Primary outcomes:
measure: oxygen saturation value
timeFrame: For 15 minutes during sleep endoscopy. At Day 0.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute
name: Hyun Joo Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04379102: The Role Of Local Anesthetics in the Management of Adverse Effects Associated With Intrauterine Device Application
Official title: The Role Of Local Anesthetics Effects During Intrauterine Device Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IUD
Contraception
Pain
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with underlying chronic diseases which could cause chronic pelvic pain such as endometriosis and which makes them prone to infections such as diabetes mellitus were excluded from the study. Furthermore, women by whom a complication had arised during the IUD insertion, such as uterine perforation, were also excluded from the study.

Brief summary: Patients who visited our family planning clinic and opted for IUD application for contraception purposes were also offered NT/TLA treatments simultaneously. 40 patients who matched the inclusion criteria and received IUDs and NT/TLA treatments were included in the study group and 41 patients who only received IUDs were included in the control group. All patients received copper IUDs and none of them were on additional hormonal treatment. Before the insertion of IUD, women in the therapy group received NT treatment with 6ml of 1% procaine injected transvaginal into the cervix at 5 and 7 o'clock localizations. Following IUD insertion, another 6ml of 1% procaine was injected into the Frankenhauser ganglia bilaterally. A final dose of 8ml of 1% procaine was injected into the abdominal trigger points and intracutaneously into the L4-S4 dermatomes as quaddles.


Eligibility criteria: Inclusion Criteria:

* not pregnant women
* healty women age between 18- 45 years old

Exclusion Criteria:

* chronic diseases which could cause chronic pelvic pain such as endometriosis
* which makes them prone to infections such as diabetes mellitus
* complication had arised during the IUD insertion, such as uterine perforation

Primary outcomes:
measure: The VAS scores of patients after the application of IUDs
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT03782402: Cannabinoids for Taxane Induced Peripheral Neuropathy
Official title: The Effect of Dispensed Cannabis on Taxane Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 12
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Taxane-induced peripheral neuropathy (TIPN) affects a significant number of women undergoing breast cancer treatment. Some patients may need to shorten their course of treatment, and do not receive the full benefit of chemotherapy as a result. Rodent studies have shown that the cannabinoids may significantly improve hyperalgesia and allodynia induced by paclitaxel. The goal of this study is to investigate the cannabinoids THC and CBD for TIPN.

Detailed description: The investigators' goal is to study the efficacy of cannabinoids as a potential treatment for TIPN. Volunteers with a diagnosis of breast cancer and chemotherapy-induced peripheral neuropathy, secondary to treatment with paclitaxel or docetaxel, will be enrolled. This study involves the administration of cannabinoids in different strength capsules. The primary outcome measures include measures of pain and functional impairment (non-painful symptoms). The scales will include: 1) Brief Pain Inventory-Short Form (BPI) for pain severity ; and 2) BPI pain interference subscale for functional impairment. The study outcomes will also include secondary measures of perception, which will be performed in the laboratory.

Eligibility criteria: Inclusion Criteria:

* 1) Participants with breast cancer, experiencing TIPN due to paclitaxel or docetaxel.
* 2) Participants must have an ECOG score of 2 or better. Participants must have a score of 2 or 3 score for sensory neuropathy, as assessed by the Common Toxicity Criteria Adverse Events (CTCAE).
* 3) Able to give informed consent and comply with all study procedures.

Exclusion Criteria:

* 1) Diagnosis of a major medical, neurological, or psychiatric disorder that would preclude study participation.
* 2) Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant.
* 3) Subjects taking warfarin.
* 4) Subjects with orthostatic hypotension, hypertension, cardiovascular disease, or neurodegenerative disorders.

Primary outcomes:
measure: Brief Pain Inventory-Short Form (BPI)
timeFrame: value at the later time (8 weeks) point minus the value at the earlier time point (baseline)
Secondary outcomes:
Other outcomes:
measure: Functional Assessment of Cancer Therapy Taxane
timeFrame: Baseline and weekly until end of study.
Locations:
city: New York
country: United States
facility: 1051 Riverside Drive
state: New York
Study officials:
References:
Clinical trial NCT02089321: Multiplanar Lumbopelvic Control in Patients With Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: low back pain
lumbopelvic assessment
active straight leg raise
active hip abduction
Lead sponsor: Regis University
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with low back pain were recruited from the physical therapy clinic located at Regis University as well as clinical practices from the surrounding area. Control subjects were a community sample.

Brief summary: The purpose of this study was to investigate whether combined assessment of lumbopelvic control during sagittal and frontal plane motion (using two common clinical observational assessments) discriminates between people with and without LBP than single plane assessment alone. It was hypothesized that the two tests used in combination (multiplanar) would perform better than each test used independently (single planar) in accurately discriminating patient cases from healthy controls.


Eligibility criteria: Inclusion Criteria:

* Patients with LBP

Inclusion Criteria:

* Age 18-70 years old
* Ability to understand and follow written and verbal instruction in English
* Seeking treatment from a physical therapist for LBP (pain below T12-L1 vertebral segment), prior to initial evaluation (no treatment provided)

Matched Controls: Control subjects will be matched for age, gender, and BMI category to patients with LBP.

Inclusion Criteria:

* Ability to understand and follow written and verbal instruction in English
* No history of LBP during the past 5 years requiring:

  * \> 3 day absence from work/school/recreation
  * Clinical Care (MD, DC, DPT, MT) for LBP

Exclusion Criteria:

Patients with LBP

* Pregnancy within past 12 months
* Previous spine or hip surgery
* Serious spinal or systemic pathology
* Inability to transfer from standing to supine to sidelying to prone
* Inability to stand \> 20 minutes

Matched Controls

Exclusion Criteria:

* Pregnancy within the past 12 months
* Previous spine or hip surgery
* Inability to transfer from standing to supine to side-lying to prone
* Inability to stand \> 20 minutes

Primary outcomes:
measure: Performance on Active Hip Abduction Test
timeFrame: Assessed on data collection day
measure: Performance on Active Straight Leg Raise Test
timeFrame: Assessed on data collection day
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Regis University
state: Colorado
Study officials:
References:
Clinical trial NCT02535221: Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer
Official title: Randomized Trial of Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With Estrogen Receptor-Positive HER2 Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Premenopausal Patients
Estrogen Receptor-Positive HER2 negative
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 234
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.


Eligibility criteria: Inclusion Criteria:

* 35 years old \<age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed primary invasive breast cancer
* Stage: T2N0M0(cT\>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast)
* Histologically confirmed HR+ (ER or PR positive, and \>50% cell in IHC) HER2 negative breast cancer by pathological evaluation
* No other previous treatment for primary breast cancer
* Without other tumor or unstable complication or uncontrolled infection
* No contradiction for the third generation AIs, LHRHa, chemotherapy
* Attend the study voluntarily, sign the informed consent.

Exclusion Criteria:

* Metastasis disease by pathological or radiological diagnosis
* the history of other tumor
* contradiction for the third generation AIs, LHRHa, chemotherapy
* Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other situation or complication that are not suitable or cannot adaptable for chemotherapy
* Contradiction for proceeding surgery: contradiction for anesthesia, large lesion,T4, lymph node positive
* other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem
* have been attendance in other anti-tumor treatment or other clinical trials 8) reject to attend the study

Primary outcomes:
measure: ultrasound response rate
timeFrame: within 2 weeks before surgery
Secondary outcomes:
measure: pathological response rate(Miller & Payne standard)
timeFrame: with 2 weeks after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital Breast Center
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Tao Ouyang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05135221: Combination Therapy With Two Biologicals
Official title: Combining Biological Therapies in Patients With Inflammatory Bowel Disease: a Finnish Multi-centre Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IBD
Keywords: biological
combination therapy
adalimumab
ustekinumab
vedolizumab
golimumab
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 16
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: IBD patients treated in Finnish tertiary centers.

Brief summary: The efficacy and safety of dual biological therapy.

Detailed description: Data of all patients treated with the combination of two biologicals in four Finnish tertiary centres were collected and analysed. Inclusion criteria were simultaneous use of two biological treatments (infliximab, adalimumab, golimumab, vedolizumab or ustekinumab), age 16 years or over and follow-up for at least induction period after introduction of second biological therapy. The primary outcome was effectiveness, defined as remission assessed by physician after at least four months of DBT. The secondary outcome was safety defined by any adverse events or infection complications during DBT.

Eligibility criteria: Inclusion Criteria:

* Simultaneous use of two different biological treatments for IBD.
* Treatment duration with combination therapy for at least for induction period.

Exclusion Criteria:

-Age under 16 years.

Primary outcomes:
measure: Clinical response
timeFrame: 18 months
Secondary outcomes:
measure: Endoscopic response
timeFrame: 18 months
measure: Haemoglobin level improvement
timeFrame: 18 months
measure: Calprotectin level improvement
timeFrame: 18 months
measure: C-reactive protein level improvement.
timeFrame: 18 months
measure: Treatment related infections
timeFrame: 18 months
Other outcomes:
Locations:
city: Lempäälä
country: Finland
facility: Heli Eronen
Study officials:
affiliation: Kanta-Häme Central Hospital
name: Heli Eronen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04491721: Follow-up the OS and PFS of Rituximab Biosimilar HLX01 and MabThera, in Untreated Subjects With CD20+ DLBCL
Official title: Long-term Follow-up the OS and PFS of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Diffuse Large B Cell Lymphoma
Keywords: rituximab
overall survival
progression-free survival
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2020-07-29
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have participated in Phase III study. Phase III study（NCT02787239）was rituximab biosimilar HLX01 and MabThera in patients with diffuse large B-cell lymphoma.

Brief summary: The main objective of this study is to observe the overall survival of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+ DLBCL. The secondary objective of this study is to observe the progression-free survival of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+ DLBCL.

Detailed description: 1. Enrollment:407 subjects.
2. The inclusion criteria of this study: subjects who have participated in Phase III clinical trials.Phase III clinical trial（NCT02787239） has ended.
3. The exclusion criteria: ①Subjects died; ②Subjects are unwilling to participate in follow-up study; ③ the investigator judges that the subject is not suitable for participating the study.
4. Duration and method of follow-up: 2-10 years (2020-2027)after the end of the Phase III trial and follow up the subjects by the phone.
5. Statistical analysis method: For progression-free survival and overall survival (OS), the median time and its 95% confidence intervals will be calculated by the Kaplan-Meier method.The Log-Rank test will be used for finding the difference between groups. The efficacy will be analyzed by SAS9.4 , and all hypothesis tests are two-sided. The confidence level of all confidence intervals is 95%. P value less than 0.05 was regarded as statistically significant.

Eligibility criteria: Inclusion Criteria:

* Subjects who have participated in Phase III study（NCT02787239）.

Exclusion Criteria:

* ①Subjects died; ②Subjects are unwilling to participate in follow-up study; ③ the investigator judges that the subject is not suitable for participating the study.

Primary outcomes:
measure: overall survival
timeFrame: up to 8 years
Secondary outcomes:
measure: progression-free survival
timeFrame: up to 8 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Yuankai Shi, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03200821: An Open Label Study to Evaluate G17DT Compared to Gemcitabine
Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of 250 µg G17DT or 1000 µg/m^2 Gemcitabine in Subjects With Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Lead sponsor: Cancer Advances Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-27
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, open, parallel group, active comparator
Primary purpose: TREATMENT

Brief summary: In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in advanced pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of pancreatic adenocarcinoma, confirmed by histology or cytology, in patients not suitable for pancreatic tumor resection with curative intent.
* A diagnosis of recurrent pancreatic adenocarcinoma (previously confirmed by histology or cytology) in patients who have had a primary tumor resection.
* Male or female patients over 18 years of age.
* Laboratory values within the following ranges at screening:

Serum creatinine \< 1.25 times upper limit of normal (ULN) Haemoglobin \> 9.5 g/dL White blood cell (WBC) count \> 3.5 x 109/L Platelets \> 100 x 109/L Total bilirubin \< 2.0 times ULN Aspartate transaminase (AST, SGOT) \< 3 times ULN

* A life expectancy of at least 2 months.
* A negative pregnancy test at the screening visit (females of childbearing potential only).
* Signed written informed consent.

Exclusion Criteria:

* History of other malignant disease (except basal cell carcinoma or in situ carcinoma of the uterine cervix).
* Previous cytotoxic chemotherapy (including gemcitabine).
* Previous radiotherapy within 30 days of baseline.
* Use of systemic (oral or injected) immunosuppressants, including corticosteroids, within 30 days prior to the baseline visit. Inhaled corticosteroids for chronic obstructive pulmonary disease or asthma were permitted.
* Females of child bearing potential who are pregnant, lactating, or who are planning to become pregnant during the period of the study.
* Participation in another study involving an investigational drug within 90 days of baseline.

Primary outcomes:
measure: Survival
timeFrame: Baseline (Week 0) up to Week 52 or death.
Secondary outcomes:
measure: Tumor Response
timeFrame: Weeks 0, 12, 24, 36 and 52
measure: Quality of Life
timeFrame: Weeks 0, 6, 12, 24, 36 and 52
measure: Quality of Life
timeFrame: Weeks 0, 6, 12, 24, 36 and 52
measure: Karnofsky Performance Status
timeFrame: Week 0 to Week 52
measure: Gastrin-17 Antibodies
timeFrame: Weeks 0, 6, 12, 24, 36 and 52
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00771121: Effect of Moisturizing Creams on Skin Barrier Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atopic Eczema
Lead sponsor: ACO Hud Nordic AB
Sponsor class: INDUSTRY
First posted: 2008-10-13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study is a randomized, double-blind, placebo-controlled bilateral study on the effect of moisturizing creams on skin barrier function. The hypothesis is that a new active emulsion has a better influence on skin barrier function comapred to its placebo.


Eligibility criteria: Inclusion Criteria:

* Dry skin barrier disorders such as atopic dermatitis or Malassezia eradicated head and neck dermatitis.
* Rough or clinically normal skin on the volar aspect of the forearm.
* Either gender
* Age between 18 and 65 years
* Written Informed Consent

Exclusion Criteria:

* Possible allergy to ingredients in the study medications.
* Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy.
* Any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse).
* Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results.
* Pregnancy or breast feeding, or patients who plan to become pregnant during the course of the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Sophiahemmet
city: Stockholm
country: Sweden
facility: Sophiahemmet
Study officials:
References:
Clinical trial NCT04535921: Fear of Cancer Recurrence in Genitourinary Cancer
Official title: Fear of Cancer Recurrence in Malignant Diseases of the Genitourinary Tract
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fear of Cancer Recurrence
Prostate Cancer
Renal Cell Cancer
Urothelial Carcinoma
Testicle Cancer
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed genitourinary malignant disease undergoing curative surgical treatment

Brief summary: To perform an analysis of independent predictors of fear of cancer recurrence in patients with malignant genitourinary diseases and their impact on quality of life and survival


Eligibility criteria: Inclusion Criteria:

* histologically confirmed diagnosis of either prostate, urothelial cell, testicular or renal cell cancer

Primary outcomes:
measure: Changes in fear of cancer recurrence pre- and postoperatively
timeFrame: 7 to 10 days after initial surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig-Maximilian-Universität
state: Bavaria
Study officials:
References: