louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00156273: Determine Feasibility of Quantifying Apoptosis and Bcl-2 Expression in CTCs in Women With Metastatic Breast Cancer
Official title: A Pilot Study to Determine the Feasibility of Quantifying Apoptosis and Bcl-2 Expression in Circulating Tumor Cells (CTCs) in Women Undergoing Treatment for Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women with metastatic breast cancer

Brief summary: We are trying to develop better ways to detect when cancer therapies are working.


Eligibility criteria: Inclusion Criteria:

1.Females at least 18 years of age 2 Diagnosis of metastatic breast cancer 3.ECOG Score of 0-2 4.Treating oncologist has decided to initiate any new systemic therapy with emphasis on recruiting patients commencing a taxane-based regimen. Taxine-based therapy may be docetaxel or paclitaxel, and it can be given on any schedule,including weekly or every 3 weeks. Other treatment can include non-taxane chemotherapy or trastuzumab-with or without other therapy.

5.Patient is willing to return for one or more additional \~18 mL blood draw (s) at 24-48-, and /or 72 hours and \~3-4 weeks after the initiation of therapy.At a minimum, patients must donate blood at baseline, one intermediate interval (24, 48, 72 hr) and at \~3-4 weeks 6.Signed Informed Consent Form

-

Exclusion Criteria:

Patient is unable and unwilling to provide a blood specimen at a minimum of one of the intermediate blood draw time points at 24, 48, or 72 hours -

Primary outcomes:
measure: To determine the feasibility of detecting Bcl2 expression and apoptosis in CTCs
timeFrame: Prospective
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Jeffrey Smerage, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04521673: Pathogen Detection in Infectious Uveitis
Official title: Pathogen Detection in Infectious Uveitis in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infectious Panuveitis
Infectious Iridocyclitis
Keywords: infectious uveitis
pathogen
PCR
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient at a referal hospital eye clinic with clinically suspected infectious uveitis, who undergo AC tap or diagnostic vitrectomy

Brief summary: Infectious uveitis is a very important blinding disease. Some people who have been diagnosed with idiopathic uveitis may also have the activity of pathogens in the eye. However, due to the limitation of the amount of ocular samples, it is difficult to make a rapid and effective diagnosis of infection.Current study is to explore the infective cause of uveitis in China by using a broad diagnostic approach of detection.

Detailed description: Infectious uveitis is a very important blinding disease. Some people who have been diagnosed with idiopathic uveitis may also have the activity of pathogens in the eye. However, due to the limitation of the amount of ocular samples, it is difficult to make a rapid and effective diagnosis of infection.

The study is to explore the infective cause of uveitis in China by using a broad diagnostic approach of detection, including multiple molecular bio-techniques. We also plan to explore the distribution of pathogens in infectious uveitis.

Eligibility criteria: Inclusion Criteria:

* Patient at a referal hospital eye clinic with clinically suspected infectious uveitis

Exclusion Criteria:

* Patients not eligible for the Inclusion Criteria
* Confirmed auto-immune uveitis

Primary outcomes:
measure: Prevalence and distribution of intraocular infections in the study group
timeFrame: Oct 2020 to Sep 2022
Secondary outcomes:
measure: The sensitivity and specificity of multiple molecular diagnostic methods for detection of bacteria or virus fungi in the study group
timeFrame: Oct 2020 to Sep 2022
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Ping Fei, MD，PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01699373: A Trial on Ultrasound-assisted Spinal Anaesthesia
Official title: A Randomised Controlled Trial on Ultrasound-assisted Spinal Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anaesthesia
Ultrasound
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 170
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with manual palpation to identify landmarks for performance of spinal anaesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA I to III
* undergoing surgery amenable to spinal anaesthesia

Exclusion Criteria:

* Patient refusal
* contraindications to regional anaesthesia
* known allergy to local anaesthetics
* bleeding diathesis
* inability to provide informed consent

Primary outcomes:
measure: Success Rate of First-attempt of Spinal Anaesthesia
timeFrame: During procedure
Secondary outcomes:
measure: Time Taken to Perform Spinal Anaesthesia
timeFrame: During procedure
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
References:
Clinical trial NCT06735573: Protein, Sarcopenic Obesity, and COPD
Official title: Observational Study to Explore the Relationship Between Dietary Protein Intake and the Prevalence of Sarcopenic Obesity in Adult Female With Chronic Obstructive Pulmonary Disease (COPD): A Pilot Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sarcopenic Obesity
Chronic Obstructive Pulmonary Diseases
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with clinically diagnosed COPD, from GP practices in Aberdeen,United Kingdom, through the Primary Care Research Network.

Brief summary: Both sarcopenic obesity and chronic obstructive pulmonary diseases (COPD) are common conditions that mainly affect middle-aged and older adults. Previous research has shown that increased dietary intake of total and plant-based protein is associated with a lower risk of sarcopenic obesity, using data from the EPIC Norfolk study. Furthermore, a systematic review and meta-analysis showed that having sarcopenic obesity was associated with significantly impaired lung function outcomes. Other research has shown that increased intake of dietary protein leads to a better treatment outcome for respiratory diseases. The aim of this pilot observational study is to investigate, in more detail, the relationship between the quantity and source of dietary protein intake, the prevalence of sarcopenic obesity, and lung function, in a small cohort of older female participants with COPD. The study will also consider the role of inflammation in relation to sarcopenic obesity and lung function outcomes. This study will help to improve the understanding of the relationship between sarcopenic obesity and lung function outcomes, and how dietary protein intake and inflammation can affect this relationship and each of the outcomes.


Eligibility criteria: Inclusion Criteria:

* Women.
* Clinically diagnosed with COPD.
* Aged 55 years or older.

Exclusion Criteria:

* Male.
* Women who are 54 years or younger.
* Those who have dementia.
* Unable to read or write in English.
* Unable to attend the Human Intervention Studies Unit.
* Those within one year life expectancy.
* Those who have cancer.

Primary outcomes:
measure: Association between dietary protein and the prevalence of sarcopenic obesity
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Association between dietary protein and lung functions outcomes
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06736873: Effect of Light Color on Stress, Anxiety, and Psychological Well-being During Nonstress Test in Pregnant Women at Risk
Official title: Effect of Light Color on Stress, Anxiety, and Psychological Well-being During Nonstress Test in Pregnant Women at Risk: A Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnant Women
Stress
Light
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose of the research:

To determine the effect of light color on stress, anxiety, and psychological well-being during the Nonstress Test in at-risk pregnant women. This research was planned as a single-blind randomized controlled experimental type study by comparing separate groups in the form of experiment-placebo control. Data will be collected with the Introductory Information Form, Psychological Well-being Scale, Perceived Stress Scale (PSS/PSS-14), State Trait Anxiety Inventory (STAI). The NST device is used to follow up pregnant women in the last 3 months of pregnancy, first monthly, then every two weeks and once a week. In other words, the procedure is routinely performed on every pregnant woman who comes for control. It is a device that shows the well-being of the baby and whether the mother has contractions. It is attached to the pregnant woman's abdominal area and does not cause any harm. It is not an invasive procedure. Pregnant women in the last 3 months of pregnancy who come to have NST for follow-up will be randomly selected and divided into 2 groups. A lamp with adjustable light level with Unit Unit Ut-383 Mini Luxmeter (Light Meter) will be placed in the intervention and control groups and the light level of the lamp will be adjusted to 100 lux. NST will be taken under cold (bluish white) light for the control group and under medium warm white (daylight white) light for the intervention group. Pre-test before the application and post-test after the application will be applied. The application is an invasive application that will not disturb the pregnant woman.


Eligibility criteria: Inclusion Criteria:

* Being at risk of pregnancy,
* being in the last trimester of pregnancy,
* being a volunteer.

Exclusion Criteria:

* Having any problem that prevents communication (such as not knowing Turkish, having hearing, speaking and understanding disorders),
* being on psychiatric treatment (pharmacotherapy or psychotherapy),
* having a disease in their eyes that prevents them from seeing

Primary outcomes:
measure: stress scale
timeFrame: 2 minutes
measure: anxiety scale
timeFrame: 2 minutes
measure: psychological well-being scale
timeFrame: 1 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03066973: BREATHING EXERCISES FOR LABOR PAIN AND DURATION
Official title: THE EFFECTIVENESS OF BREATHING EXERCISES TO LABOR PAIN and DURATION: A RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Breathing Exercise
Keywords: breath exercises
labor pain
labor duration
VAS
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to assess the efficacy of breathing exercises (BE) during the second stage of labor for maternal pain, duration of labor and first-minute APGAR score. This is a randomized controlled trial that compares nulliparous pregnant in the second stage of labor instructed regarding BE with a control group (CG) that received standard care service. It was conducted at Nenehatun Obstetric and Gynecology Hospital between May-June 2016, in Erzurum. One session of BE training were given to pregnant in intervention group (IG). Visual Analog Scale (VAS) was performed to identify perception of pain to all pregnant during the second stage of birth. Time of the second stage was recorded as second (sec), and first minute APGAR scores were recorded. Significance was set at p\<0.05.

Detailed description: In this trial, it is aimed to assess the effectiveness of breathing exercises (BE) for management of labor pain during the second stage of labor. Nulliparous pregnant were randomized two arms. Intervention group received breathing exercise at the first stage of labor. Control group received routine care services. It was conducted at Nenehatun Obstetric and Gynecology Hospital between May-June 2016, in Erzurum, Turkey. Visual Analog Scale (VAS) was performed to identify perception of pain to all pregnant during the second stage of labor. Time of the second stage was recorded as second (sec), and first minute APGAR scores of newborn were recorded. All analysis was carried out using SPSS 20. Significance was set at p\<0.05.

Eligibility criteria: Inclusion Criteria:

* Nullipar females
* Gestational age 37-42 week

Exclusion Criteria:

* Analgesic and anestezice use
* Clinical instability
* Psychiatric disorders

Primary outcomes:
measure: Labor pain
timeFrame: 1 MONTH
Secondary outcomes:
measure: Duration of labor
timeFrame: 1 MONTH
measure: APGAR score
timeFrame: 1 MONTH
Other outcomes:
Locations:
Study officials:
References:
citation: Yuksel H, Cayir Y, Kosan Z, Tastan K. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: a randomized controlled trial. J Integr Med. 2017 Nov;15(6):456-461. doi: 10.1016/S2095-4964(17)60368-6.
Clinical trial NCT02394873: A Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound
Official title: A Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Deep Second-degree Burn Wound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Burn
Keywords: Deep Second-Degree Burn Wound
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase I study to evaluate the safety of ALLO-ASC-DFU for the treatment of deep second-degree burn wound patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a burn.


Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years of age and older.
2. Subjects who have deep second-degree burn ≥100 cm\^2.
3. Negative for urine beta-HCG for women of childbearing age.
4. Subject is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Subjects who have been enrolled in another clinical study within 30 days of screening.
2. Subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
3. Subjects who are receiving steroids, immunosuppressive, or anticoagulant.
4. Subjects with active infection.
5. Subjects with hemorrhagic and hemocoagulative disease
6. Subjects who are unwilling to use an "effective" method of contraception during the study.
7. Subjects who have a history of malignant tumor within the last five years, or is currently undergoing.
8. Subjects who are pregnant or breast-feeding.
9. Subjects who are considered to have a significant disease which can impact the study by the investigator
10. Burn wound is present on any part of the face.
11. Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma site).
12. Subjects who are considered not suitable for the study by the investigator.
13. Subjects who are not able to understand the objective of this study or to comply with the study requirements.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Time to reach re-epithelialization of wound
timeFrame: 1, 2, 4 weeks
measure: Vancouver Burn Scar Scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hallym university Medical Center
Study officials:
affiliation: Hallym University Medical Center
name: Wook Chun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06171373: Extension for Menopause Sample Collection
Official title: Extension for Menopause Sample Collection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy female volunteers

Brief summary: This study will provide urine samples from women going through the menopause transition in order to maintain the SPD sample bank.

Symptom information and cycle length will also be recorded to observe how these change through the menopause transition.

Detailed description: This is an extension to a previous sample collection (Protocol-1326) where additional samples will be collected from the women who continue to go through the menopausal transition (i.e. are not post-menopausal).

Three sets of 10 consecutive daily urine samples will be collected at three timepoints (month 0, month 6 and month 12).

Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts and stored at -80˚C until required.

Eligibility criteria: Inclusion Criteria:

* Pre- and peri-menopausal volunteers(assigned by STRAW+10 criteria) who completed PROTOCOL-1326

Exclusion Criteria:

* Post-menopausal volunteers (12 months since last menstrual period)
* Use of hormone replacement therapy (HRT)
* Use of hormone contraception
* Hysterectomy and/or oophorectomy
* Pregnant or breast feeding
* Other medical reason for amenorrhea (absence of menstruation)

Primary outcomes:
measure: Number of Urine Samples Collected
timeFrame: Daily samples for 10 days at 0, 6 and 12 months
Secondary outcomes:
measure: Menopause Symptom Questionnaire
timeFrame: Recorded at 0, 6 and 12 months
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd
state: Bedfordshire
Study officials:
affiliation: SPD Development Company
name: Raniero Zazzeroni
role: STUDY_DIRECTOR
affiliation: SPD Development Company
name: Jackie Boxer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04117373: Mohs Micrographic Surgery and Reconstruction in the Optum Insurance Claims Database
Official title: Characterizing Trends in Mohs Micrographic Surgery and Complex Reconstruction in the Optum Healthcare Population
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Skin Cancer
Mohs Micrographic Surgery
Interpolated Flap Repair
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was conveniently sampled from the compilation of de-identified claims in the Optum© Clinformatics® database using ICD9 and ICD10 codes specific for skin cancer and linking them to specific CPT codes for interpolated flap repair, a reconstructive skin surgery. The investigator's population is composed of \>7,000 patients across the United States who received a skin cancer diagnosis and this procedure between 2001 and 2016.

Brief summary: Mohs micrographic surgery (MMS) followed by skin reconstruction has been widely accepted for treatment of many skin cancers. To further characterize the trends in MMS and reconstruction for skin cancer, a retrospective analysis will be performed using the Optum© Clinformatics® DataMart de-identified commercial claims database from 2001-2016. The findings may provide critical data for future prospective studies in skin cancer treatments.


Eligibility criteria: Inclusion criteria:

- All patients in the Optum© Clinformatics® database who have an ICD9 or ICD10 code for skin cancer and a corresponding CPT code specific for interpolated flap reconstruction

Exclusion criteria:

- All patients for whom cost data is missing in the Optum© Clinformatics® DataMart

Primary outcomes:
measure: Primary cost
timeFrame: Claims from 2001-2016 will be analyzed
Secondary outcomes:
measure: Predictors of inpatient vs. outpatient procedure
timeFrame: Claims from 2001-2016 will be analzyed
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jeremy Etzkorn, MD
role: PRINCIPAL_INVESTIGATOR
References: