louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00373620: A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients
Official title: A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy in High-Risk Endometrial Cancer Patients After Operation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: endometrial cancer
high risk
weekly paclitaxel
Cuncurrent chemoradiation
Lead sponsor: Korean Gynecologic Oncology Group
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxel is effective and safe in the treatment of high risk postoperative endometrial cancer patients.

Detailed description: Postoperative radiotherapy (RT) is the most used adjuvant treatment in high risk endometrial cancer (HREC), and it appears to reduce the incidence of pelvic relapses but doesn't seem to improve survival. Paclitaxel (P) has shown in vitro and clinical activity against endometrial cancer, and it is also a potent radiosensitizer by blocking dividing cells in G2/M phase. This study is to evaluate the efficacy and safety of a treatment with concomitant weekly chemotherapy with paclitaxel and RT in high risk advanced endometrial cancer.

Eligibility criteria: Inclusion Criteria:

* Patients undertaken total hysterectomy, bilateral salpingoophorectomy, washing cytology, pelvic and paraaortic lymph node dissection
* Patients must have the diagnosis of endometrioid type adenocarcinoma with stage III, IV.
* Patients must have a GOG performance of 0, 1, or 2.
* Patients must have expected life span over 6 months.

Exclusion Criteria:

* Patients with peripheral neurotoxicity over grade 2 in CTC criteria.
* Patients with history of chemotherapy or radiation treatment.
* patients with history of arrhythmia,congestive heart failure.
* Patients with intractable infection.

Primary outcomes:
measure: Two year progression free survival
Secondary outcomes:
measure: toxicity profile
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Young-Dong Severance Hospital
Study officials:
affiliation: Yong-Dong Severance Hospital
name: Jae-Hoon Kim, Professor
role: STUDY_CHAIR
References:
citation: Cho H, Nam BH, Kim SM, Cho CH, Kim BG, Ryu HS, Kang SB, Kim JH. A phase 2 trial of radiation therapy with concurrent paclitaxel chemotherapy after surgery in patients with high-risk endometrial cancer: a Korean Gynecologic Oncologic Group study. Int J Radiat Oncol Biol Phys. 2014 Sep 1;90(1):140-6. doi: 10.1016/j.ijrobp.2014.05.024. Epub 2014 Jul 8.
Clinical trial NCT00281320: Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)
Official title: A Randomized, Parallel Group, Multiple Dose, 6-Week Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly Subjects With Psychosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psychosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-01-24
Enrollment: 122
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.


Eligibility criteria: Inclusion Criteria:

* Elderly subjects with psychosis

Exclusion Criteria:

* Have an uncontrolled, unstable clinically significant

medical condition.

* Have an established diagnosis of dementia

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event
timeFrame: Up to Day 42 (treatment period)
measure: Number of Participants Who Discontinued Because of an Adverse Event
timeFrame: up to 30 days after study medication stop date
measure: Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax
timeFrame: Day 4 or 8
measure: Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax
timeFrame: Day 4 or 8
measure: Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax
timeFrame: Day 4 or 8
measure: Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin
timeFrame: Day 4 or 8
measure: Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12
timeFrame: Day 4 or 8
measure: Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12
timeFrame: Day 4 or 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Dubovsky SL, Frobose C, Phiri P, de Greef R, Panagides J. Short-term safety and pharmacokinetic profile of asenapine in older patients with psychosis. Int J Geriatr Psychiatry. 2012 May;27(5):472-82. doi: 10.1002/gps.2737. Epub 2011 Jul 13.
Clinical trial NCT05516420: Predicting Abdominal Reoperation
Official title: Predicting Long-term Risk of Reoperations Following Abdominal and Pelvic Surgery: a Nationwide Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Abdominal Adhesion
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: NHS Research Scotland
First posted: 2022-08-25
Enrollment: 72270
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing first abdominal or pelvic surgery between June 1st 2009 and June 30th 2011 in Scotland.

Brief summary: Nationwide retrospective study, to predict the risk of abdominal reoperation.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing first abdominal or pelvic surgery between June 1st 2009 and June 30th 2011 in Scotland.

Exclusion Criteria:

* Positive history for abdominal surgery

Primary outcomes:
measure: Number of patients with an abdominal reoperation in the study cohort
timeFrame: within 5 years postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05693220: Sperm Preparation Prior to Intrauterine Insemination Study
Official title: The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Infertility Secondary
Infertility Unexplained
Anovulation
Fertility Disorders
Reproductive Issues
Keywords: Intrauterine Insemination
Insemination
Fertility
Infertility
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.

Detailed description: Study participants will be randomized to either standard sperm preparation (density gradient centrifugation) versus sperm preparation with the Zymot Multi sperm preparation device for their three month intrauterine insemination treatment course. Patients will follow standard treatment plans designed by their fertility physician and will be followed until referred for prenatal care at 8-10 weeks of pregnancy to determine pregnancy outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing intrauterine insemination
* Patient assigned female at birth with age \<41

Exclusion Criteria:

* Any significant disease or psychiatric disorder that would interfere with the consenting process
* Prior intrauterine insemination
* Use of frozen donor sperm
* Non-English speaker

Primary outcomes:
measure: Cumulative clinical pregnancy rate
timeFrame: 3 treatment cycles, an average of 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Center for Reproductive Health
state: California
Study officials:
affiliation: University of California, San Francisco
name: Mitchell Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gode F, Bodur T, Gunturkun F, Gurbuz AS, Tamer B, Pala I, Isik AZ. Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles. Fertil Steril. 2019 Nov;112(5):842-848.e1. doi: 10.1016/j.fertnstert.2019.06.037. Epub 2019 Sep 19.
citation: Quinn MM, Jalalian L, Ribeiro S, Ona K, Demirci U, Cedars MI, Rosen MP. Microfluidic sorting selects sperm for clinical use with reduced DNA damage compared to density gradient centrifugation with swim-up in split semen samples. Hum Reprod. 2018 Aug 1;33(8):1388-1393. doi: 10.1093/humrep/dey239.
Clinical trial NCT03424720: Comparative Analysis of Phase Lag Entropy (PLE) and Bispectral Index (BIS) as an Anesthetic Depth Indicator
Official title: Comparative Analysis of Phase Lag Entropy (PLE) and Bispectral Index (BIS) as an Anesthetic Depth Indicator in Patients Undergoing Otopharyngeal Surgery With Facial Nerve Integrity Monitoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this comparative analysis is to evaluate the reliability of PLE value as an anesthetic depth indicator

Detailed description: 1. To evaluate the reliability of PLE value as an anesthetic depth indicator, the investigators compare PLE value with BIS score during induction and emergence of general anesthesia using propofol target controlled infusion.
2. In addition, the investigators verify whether or not the facial nerve integrity monitoring affects the efficacy for PLE and BIS values as an anesthetic depth indicator.

Eligibility criteria: Inclusion Criteria:

* Patients who scheduled for otopharyngeal surgery under facial nerve integrity monitoring requiring general anesthesia and American Society of Anesthesiology (ASA) physical status 1 or 2

Exclusion Criteria:

* Patient who has been taken anticonvulsant agents, sedatives, and hypnotics
* Patient who has central nerve system disease, neurological disorder
* Patient with hypersensitivity to anesthetics

Primary outcomes:
measure: PLE value during induction and emergence of general anesthesia
timeFrame: Through study completion, an average of fifteen months
Secondary outcomes:
measure: BIS value during induction and emergence of general anesthesia
timeFrame: Through study completion, an average of fifteen months
measure: PLE value during facial nerve integrity monitoring
timeFrame: Through study completion, an average of fifteen months
measure: BIS value during facial nerve integrity monitoring
timeFrame: Through study completion, an average of fifteen months
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Medical Center
state: Gyeonggi-do
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine
name: Kyung Mi Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01123720: The Impact of Internationalize Medical Services to localPeople Seeking Medical Care
Official title: To Understand the Impacts of Internationalize Medical Services on Local People Seeking Medical Care, and to Establish Responsive Management Mechanism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Administrative Staff in Hospital of Taiwan
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
Collaborators: name: Taiwan College of Healthcare Executives
First posted: 2010-05-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Administrative staff in Hospital of Taiwan

Brief summary: Recently The Department of Health of Taiwan has launched the "Internationalize Medical Services Flagship Program", expecting to promote Taiwan's high-quality of medical services to the international market, and anticipating "customers stroll in, medical services walked out".

In order to avoid expansion of this program might alienate the rights and best interests of local people seeking medical services, therefore, this research project is a join effort of experts to form an advisory counsel; by collecting most current international medical services data; then using both qualitative and quantitative questionnaires to investigate whether by implementation of internationalize medical services will cause great impact on local people.

To study the various of insurance income of health care organization after they promote international medical services; and to understand the impact of assess to medical care and quality of medical services to local people due to internationalize medical services.

The last through advisory counsel, to make specific recommendations on mechanism of management and to set evaluation of indicators to monitor international health care, to avoid edge out local people the right of seeking medical care to ever happened, and to aid future planning of policy and implementation.

Detailed description: The main objectives of this study are:

1. To understand the impact from internationalize medical services to local People seeking medical care, and the impact to management of health care organization, make specific recommendations for assessment, management mechanisms and measurable indicators, and aid future planning of policy and implementation.
2. To avoid expanding the flagship program of internationalization of medical services might jeopardize local people's right to seek medical care, assess the impact to local people after the program implemented.

Eligibility criteria: Inclusion Criteria:

* Administrative staff in Hospital
* Hospital provide the internationalize medical services

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Lan-Chin Lu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05777720: Cluster-Randomized Trial of Air Filtration and Ventilation to Reduce Covid19 Spread in Homes
Official title: A Cluster-randomized Controlled Trial of Air Filtration and Ventilation Improvements to Reduce SARS CoV 2 Transmission Among Household Contacts
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Covid19
Keywords: ventilation
air filtration
Covid19
SARS CoV 2
household transmission
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-03-21
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Investigators are evaluating whether an intervention consisting of box-fans with MERV 16 filters ("filtration fans") and recommendations for improving ventilation in the home can reduce secondary spread of Covid19 from an index case to susceptible contacts within the home.


Eligibility criteria: Inclusion Criteria:

* Household members live in a shared space (apartment, home) with others (as opposed to renting single rooms in a shared space, for example)
* At least 3 other people live in the household aside from index case

Exclusion Criteria:

* If index case test positive day was over 2 days prior
* If half or more household members are thought to be infected already
* If household has fewer than 3 contacts interested in participating in the study
* If fewer than 3 contacts are expected to be present in the house for a majority of the following 7 days

Primary outcomes:
measure: Incidence of Covid19
timeFrame: 7th day since enrollment in the trial
Secondary outcomes:
measure: Incidence of new upper respiratory symptoms
timeFrame: 7th day since enrollment in the trial
measure: Average CO2 levels
timeFrame: 7 days
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: San Mateo Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Yvonne Maldonado, MD
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Abraar Karan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04826120: Continuous Versus Intermittent Administration of Epidural Analgesia During Labor
Official title: Continuous Versus Intermittent Administration of Epidural Analgesia During Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural; Analgesia
Keywords: Epidural, Analgesia, Labor, delivery
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 54
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parturients randomized in 2 groups and receiving 2 different interventions
Primary purpose: TREATMENT

Brief summary: prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups.

Epidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group).

Detailed description: prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups.

Epidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group).

The main outcome of this study was: the incidence of motor Blockage. Our secondary outcomes were: maternal satisfaction, local anaesthetic and sufentanil cumulated doses, duration of the second stage of labor, mode of delivery and pain during labor using the Visual analogic score (VAS score).

Eligibility criteria: Inclusion Criteria:

* Full term parturients scheduled for vaginal delivery

Exclusion Criteria:

* patients in whom cesarean section delivery was indicated during labor

Primary outcomes:
measure: Incidence of motor Blockage
timeFrame: during the epidural analgesia
Secondary outcomes:
Other outcomes:
Locations:
city: La Marsa
country: Tunisia
facility: Mongi Slim University Hospital
state: Tunis
city: Tunis
country: Tunisia
facility: Mongi Slim Hospital
Study officials:
References:
Clinical trial NCT00294320: Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions
Official title: Pilot Study to Evaluate Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions (Clinical and Sub-clinical), When Treated With Aldara 5% (Imiquimod) Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: Aldara
Actinic Keratosis
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2006-02-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the performance of two techniques to monitor the clearance of AK lesions when treated with Aldara 5% cream.

Detailed description: Each technique will be assessed by comparison of lesion counts (clinical and sub-clinical) revealed by the techniques, at start and end of the study and those demonstrated during treatment. In addition a qualitative assessment of each technique will be made for performance and ease of use.

Eligibility criteria: Inclusion Criteria:

* At least 5 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions
* Free of any significant findings (e.g tattoos) in the potential application site area.
* Willing to discontinue sun-tanning and use of sunbed/sun parlour use
* Willing to stop use of moisturisers, body oils, and over the counter retinol products or products containing alpha or beta hydroxyacids in the treatment or surrounding area.
* Willing ot withhold sunscreen and/or moisturiser use for 24 hours prior to each clinical assessment

Exclusion Criteria:

* Evidence of unstable or uncontrolled clinically significant medical condition.
* Any dermatological disease and or condition in the treatment of the surrounding area that may be exacerbated by treatment with imiquimod.
* Currently participating in another clinical study or have completed another study within an investigational drug within the past 30 days.
* Have active chemical dependency or alcoholism
* Have know allergies to any excipient or study cream
* Have received previous treatment with imiquimod for any indication within the treatment area.
* Known to be affected by porphyria

Primary outcomes:
measure: To compare the performance of two techniques to monitor the clearance of AK lesions (clinical and subclinical) when treated with Aldara 5% cream by comparison of lesion counts.
timeFrame: 8 weeks after the end of treatment
Secondary outcomes:
measure: To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.
timeFrame: 8 weeks after the end of treatment
Other outcomes:
Locations:
city: Nice
country: France
facility: Hopital L'Archet 2
state: Cedex 3
Study officials:
affiliation: CPCAD, Hopital L'Archet 2
name: Jean-Paul Ortonne, Professor
role: PRINCIPAL_INVESTIGATOR
References: