louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03656211: Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation
Official title: Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arteriovenous Malformations
Keywords: Uterine AVM
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 15
Sex: FEMALE
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: All the patients having a diagnosis of UAVM posed between January 1st, 2000 and March 30th, 2017, and confirmed by an imaging examination carried out at the Rennes University Hospital.

Brief summary: Uterine arteriovenous malformations (UAVM) are short circuits between systemic arterial and venous networks within the uterus. They are congenital or acquired (in the course of an endo-uterine gesture such as curettage or interventions such as caesareans or myomectomies).

They can be manifested by severe metrorrhagia that can go as far as to put the patient's vital prognosis at risk.

There are no recommendations for the management of UAVM since this pathology is rare and therefore series are performed with few cases. If some of these UAVM disappear spontaneously after a therapeutic abstention, when the clinical context allows it, in case of symptomatic UAVM, a selective embolization with arteriography is often carried out to postpone the hysterectomy of hemostasis.

There are also more marginal management options such as Gonadotropin-Releasing Hormone agonists, methotrexate or curettage that are decided on a case by case basis depending on the symptoms and protocols of each medical team.

Regarding subsequent fertility and pregnancy outcomes after conservative treatment, the number of studies is even lower.


Eligibility criteria: Inclusion Criteria:

* Major patient
* Diagnosis of UAVM, symptomatic or not, between January 1st, 2000 and March 30th, 2017 confirmed by imagery performed at the Rennes University Hospital
* Not against her participation in research

Exclusion Criteria:

* Minor patient at the time of diagnosis
* congenital UAVM
* Uterine malformation
* Patient under legal protection (guardianship, curatorship, safeguard of justice).

Primary outcomes:
measure: Evaluation of fertility
timeFrame: At the time of inclusion
Secondary outcomes:
measure: Pregnancy outcomes after UAVM
timeFrame: At the time of inclusion
measure: Term of delivery after UAVM
timeFrame: At the time of inclusion
measure: Side effects of treatments for UAVM
timeFrame: At the time of inclusion
measure: Complications of treatments for UAVM
timeFrame: At the time of inclusion
Other outcomes:
Locations:
city: Rennes cedex
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Krystel NYANGOH-TIMOH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02313311: Select Embryos by Time-lapse System for Single Embryo Transfer
Official title: Study Embryos of IVF by Time-lapse System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Embryo
Keywords: Cleavage pattern, timing parameter, time-lapse
Lead sponsor: Nanjing University
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing assistant reproduction treatment

Brief summary: The objective of this study is to establish a hierarchical embryo selection process by using the time-lapse imaging (TLI), combining the embryo cleavage patterns and timing parameters.

Detailed description: The embryos of patients undergoing in vitro fertilization (IVF) treatment is cultured to blastocyst stage and observed by TLI. The association of embryo cleavage patterns/timing parameters and good-quality blastocyst rates are evaluated by logistic regression and to establish a hierarchical embryo selection. The value of the selection process is assess by single embryo transfer (SET) on Day 3.

Eligibility criteria: Inclusion Criteria:

* Women undergoing assistant reproduction treatment

Exclusion Criteria:

* Oocyte donation cycles

Primary outcomes:
measure: good-quality blastocyst rate
timeFrame: 6 days post insemination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Reproductive Medicine Centre, Drum Affiliated to Hospital Nanjing University Medical School
name: Haixiang Sun, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05811611: Two WeChat Mini Program-based Interventions Reducing Sexual Risk Behaviors Among Heterosexual Male Factory Workers
Official title: Efficacies of Two WeChat Mini Program-based Interventions in Reducing Sexual Risk Behaviors Among Heterosexual Male Factory Workers in China: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behavior, Sex
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 244
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A non-blinded parallel group randomized controlled trial is conducted. Adult male full-time employees of factories in Shenzhen who have access to smartphone and WeChat are recruited by staff of the Longhua Center for Disease Control and Prevention (CDC).

After completing an online baseline questionnaire, participants will be randomized evenly to either the intervention group or the control group. Participants in the control group will have access to a WeChat Mini Program providing HIV and sexually transmitted prevention information during the project period. In addition to those received by the control group, the Mini Program will proactively ask participants in the intervention group some simple questions to assess presence of sexual risk behaviors at Month 0 and Month 1, and invite them to watch online health promotion video(s) tailored to their current sexual risk behaviors.

All participants will complete two online follow-up surveys six and twelve months after completion of the interventions.


Eligibility criteria: Inclusion Criteria:

* Male at birth
* Aged 18 years or above
* Full-time employee of a factory in Shenzhen
* Having a smartphone with internet access
* Having installed or willing to install WeChat on the smartphone
* Willing to complete follow-up surveys at Month 6 and 12

Exclusion Criteria:

* Oral or anal sex with a man
* Blindness ot deafness
* Not able to communicate effectively with project staff
* Self-reported as HIV positive

Primary outcomes:
measure: Sexual intercourse with non-regular female sex partner
timeFrame: 6 months
measure: Sexual intercourse with female sex workers
timeFrame: 6 months
Secondary outcomes:
measure: Condomless sex with non-regular female sex partners
timeFrame: 6 months
measure: Condomless sex with female sex workers
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Centre for Health Behaviours Research, the Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Zixin Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01048411: Trial to Investigate the Influence of the Homeopathic Remedy Naja-comp on Stroke Therapy in Geriatric Rehabilitation
Official title: Multicenter Randomized Controlled Trial to Investigate the Influence of the Homeopathic Remedy 'Naja-comp' on Stroke Therapy in Geriatric Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke rehabilitation
outcome
barthel-index
geriatrics
elderly
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2010-01-13
Enrollment: 344
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The homeopathic remedy 'naja-comp' will improve functional outcome measured by the Barthel-Index.

The homeopathic remedy 'naja-comp' will decrease complications during geriatric rehabilitation measured by rate of unplanned discharge to hospital.

Detailed description: Secondary outcome for functional improvement are Scandinavian Stroke Scale, 4D+S-Scale and Timed-Up\&Go-Test.

Eligibility criteria: Inclusion Criteria:

* stroke within 60 days after onset

Exclusion Criteria:

* stroke by injury or tumor
* stroke older than 60 days
* missing consent for participation
* participation at other clinical trials

Primary outcomes:
measure: barthel-index
timeFrame: baseline, 21st day of rehabilitation
measure: rate of unplanned discharge to hospital care
timeFrame: until day 21 of rehabilitation
Secondary outcomes:
measure: Scandinavian Stroke Scale, 4D+S-Scale, Timed-Up&Go-Test
timeFrame: baseline, 21st day of rehabilitation
Other outcomes:
Locations:
city: Bad Griesbach
country: Germany
facility: KWA Stift Rottal
state: Bavaria
city: Bad Steben
country: Germany
facility: Alexander von Humdoldt-Klijnik
state: Bavaria
city: Haag in Oberbayern
country: Germany
facility: Kreiskrankenhaus Haag - Fachklinik für Geriatrische Rehabilitation
state: Bavaria
Study officials:
affiliation: Univerity of Erlangen-Nuernberg, Director of the Institute for Biomedicine of Aging
name: Cornel Sieber, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01733511: the Patients Journey Through Surgical Admission Ward Versus Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Waiting Time in Emergency Department
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 109
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all acute admissions to hospital due to abdominal pain

Brief summary: Emergency departments are established in 20 hospitals in Denmark in order to improve the quality for the acute patients.

A group of acute patients which require timely assessment and plan from a specialist is patients with abdominal pain.

the aim of the present study is to evaluate whether the admission of the group of patients to emergency departments reduces the time to doctor, specialist and plan compared to the traditional admission to a surgical acute ward.


Eligibility criteria: Inclusion Criteria:

* age more than 15 years

Exclusion Criteria:

Primary outcomes:
measure: time in minutes
timeFrame: up to 24 hours after admission
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Schultz H, Mogensen CB, Pedersen BD, Qvist N. Front-end specialists reduce time to a treatment plan for patients with acute abdomen. Dan Med J. 2013 Sep;60(9):A4703.
Clinical trial NCT05941611: Results From Objective Brushing Data Saved From a Powered Toothbrush Related to Values for Oral Health
Official title: Results of Objective Brushing Data Recorded From a Powered Toothbrush Used by Elderly Individuals With Mild Cognitive Impairment Related to Values for Oral Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Periodontal Diseases
Keywords: Mild Cognitive Impairment
Oral Health
Powered toothbrush
Lead sponsor: Blekinge Institute of Technology
Sponsor class: OTHER
Collaborators: name: Kristianstad University
First posted: 2023-07-12
Enrollment: 213
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: For this study, 213 individuals were recruited. During the Baseline examination, each participant received a powered toothbrush and was carefully instructed on how to use the toothbrush and recommended using it for at least 2 minutes every morning and evening. No restrictions were imposed on the use of other oral health products. The study lasted from June 2018 to October 2020 and included a screening, a baseline examination, and additional reexaminations at 6 and 12 months. The Oral-B application was installed on the participant's mobile phones or computer tablets. Participants were instructed verbally and in writing on transferring data from the powered toothbrush to the application. The present study aimed to investigate how the true use of the powered toothbrush, in terms of frequency and duration, affects plaque index (PI), bleeding on probing (BOP), and periodontal pocket depth (PPD) ≥4 mm in a group of elderly individuals with MCI. A second aim was to compare the registered time and brush frequencies to the individual's self-estimated usage of the powered toothbrushes.


Eligibility criteria: Inclusion Criteria:

* Being 55 years or older
* Having experienced memory problems in the last six months before inclusion
* Having a Mini-Mental State Examination score of 20-28
* Are not receiving any formal care
* Having at least ten teeth of their own

Exclusion Criteria:

* Having a terminal illness with less than three years of expected survival
* Having another known significant cause of disease explaining cognitive impairment

Primary outcomes:
measure: Change in the amount of dental plaque
timeFrame: From Baseline to month 6 and to month12
measure: Change in the amount of gingival bleeding on probing
timeFrame: From Baseline to month 6 and to month12
measure: Change in the number of periodontal pockets 4 mm or deeper
timeFrame: From Baseline to month 6 and to month12
measure: Change of average brush time
timeFrame: From Baseline to month 6 and to month12
measure: Change in the number of brush sessions
timeFrame: From Baseline to month 6 and to month12
Secondary outcomes:
Other outcomes:
Locations:
city: Karlskrona
country: Sweden
facility: Blekinge Institute of Technology
Study officials:
affiliation: Blekinge Institute of Technology
name: Johan Sanmartin-Berglund, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00125411: Study of Satraplatin (JM-216) in Combination With Docetaxel
Official title: Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Tumors
Keywords: satraplatin
docetaxel
cancer
Phase I
advanced solid tumors
Lead sponsor: Agennix
Sponsor class: INDUSTRY
First posted: 2005-08-01
Enrollment: 28
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 single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin (JM-216), in combination with docetaxel in patients with advanced solid tumors for whom curative therapy is not available. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.

PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the combination of satraplatin and docetaxel when given to patients with advanced solid tumors.

WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective
* Life expectancy of at least 3 months
* Measurable or evaluable disease
* ECOG performance status of \<= 2
* Willingness and ability to give informed consent

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Other chemotherapy treatment less than 4 weeks prior to enrollment
* Treatment with docetaxel or a platinum agent less than 3 months prior to enrollment
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational

Primary outcomes:
measure: Maximum Tolerated Dose and Safety
timeFrame: 3 weeks
Secondary outcomes:
measure: Objective response rate
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: George Wilding, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01157611: The Effect of Online Based Mentoring Program on the Blood Glucose and Satisfaction Score in Type 1 Diabetes Patients
Official title: The Effect of Online Based Mentoring Program on the Blood Glucose and Satisfaction Score in Type 1 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: online based mentoring program,
type 1 diabetes,
blood glucose,
satisfaction score
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 57
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: Purpose:

To evaluate the effects of online based mentoring program on the blood glucose and satisfaction score in type 1 diabetes patients. Peer group mentoring will be as effective as guidance by the doctors.

Methods:

80 type 1 patients will be randomly divided into two groups (e.g. mentoring program group and control group). All patients will receive routine check up and blood test for ordinary type 1 patients. In addition, program group patients should register their SMBG, exercise, food intake and insulin dose on the website designed for this study and receive advices of mentors from peer group. Every patient will submit questionnaire on the first day of the study and the last day(after 12 weeks) of the study.

Detailed description: Subjects with T1DM on intensive insulin therapy and with hemoglobin A1c (HbA1c) ≥8.0% were randomized to mentored (glucometer transmission with feedback from mentors) or control (glucometer transmission without feedback) groups and were examined for 12 weeks. Five mentors were interviewed and selected, of which two were T1DM patients themselves and three were parents with at least one child diagnosed with T1DM since more than 5 years ago.

Eligibility criteria: Inclusion Criteria:

* age \> 18, more than 6 month after the diagnosis of type 1 diabetes
* HbA1c \> 8% despite of multiple insulin injection or insulin pump
* who are capable of using the internet

Exclusion Criteria:

* pregnant women
* who cannot use the internet
* those who does not want to participate in the study

Primary outcomes:
measure: change of the blood glucose
timeFrame: week 0 (baseline), 6, 12
Secondary outcomes:
measure: satisfaction score
timeFrame: week 0 (baseline), 6, 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jae Hyeon Kim, M.D., Ph. D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04925011: Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
Official title: An Open-label, One-center Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anemia Associated With Chronic Kidney Disease
Lead sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-labeled, one-center study is designed to evaluate the efficacy and safety of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5 who are receiving dialysis or not. The study will enroll patients between the ages of 2 to \<18 years. Approximately 30 patients will be enrolled.

Detailed description: This study is to evaluate the use of roxadustat for renal anemia in pediatric patients with CKD

Eligibility criteria: Inclusion Criteria:

1. Estimated glomerular filtration rate (Bedside Schwartz formula) of \< 60 ml/min/1.73 m2 (stage 3, 4 and 5 CKD) for dialysis or non-dialysis patients.
2. For ESA-naïve patients, mean of two most recent central laboratory Hb values during the screening period obtained at least 2 days apart must be \< 11.0 g/dL. For patients currently receiving stable ESA dosing who will discontinue ESA and convert to roxadustat during study, mean of two most recent central laboratory Hb values during the screening period obtained at least 2 days apart must be ≥ 9.0 g/dL and ≤ 12.5 g/dL
3. Ferritin \>50 ng/mL and transferrin saturation \>10%

Exclusion Criteria:

1. Uncontrolled hypertension as judged by the principal investigator prior to screening.
2. Known hematologic disease related anemia (including PRCA)
3. Known malignancy within the past 5 years before screening.
4. History of severe anaphylaxis or known allergic to ingredient of roxadusta.
5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN) and total bilirubin (Tbili) ≤2x ULN(obtained from screening visit).
6. Serum folate and vitamin B12 \> LLN and cannot be corrected (obtained from screening visit).
7. Any RBC transfusion during the past 4 weeks before screening.
8. Weight\<10kg
9. Any prior exposure to roxadustat or any other HIF-PH inhibitor.

Primary outcomes:
measure: Proportion of patients with mean Hb ≥ 11.0 g/dL
timeFrame: weeks 16-24
Secondary outcomes:
measure: Mean change in Hb
timeFrame: weeks 16-24
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Children's Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Children's Hospital, Zhejiang University School of Medicine
name: jianhua Map, MD
role: PRINCIPAL_INVESTIGATOR
References: