louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04945252: The Impact of School Teachers in Care Navigation and Signposting Dental Caries in Primary School Children
Official title: The Impact of School Teachers in Care Navigation and Signposting Dental Caries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Lead sponsor: Khartoum Centre for Research and Medical Training
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 307
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-randomized parallel design
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to investigate the role of school teachers in care navigation and signposting dental caries in primary school children.

Detailed description: Dental caries is a multifactorial disease with high prevalence in children. Dental caries is a global public health problem with detrimental impact in developing countries. Despite advances in caries management and detection poorer countries continue to suffer a high burden of disease. Advances in care navigation and sign-posting concepts are increasingly being utilized in general health care to aid early diagnosis and ease the burden of disease in poorer communities. This study aims to investigate the role of primary school teachers as care navigators with regard to dental caries in children.

Eligibility criteria: Inclusion Criteria:

Healthy school children between the ages of 5-8 years Regular school attender Lives in the local village Co-operative

Exclusion Criteria:

* known medical history or disability
* irregular school attenders

Primary outcomes:
measure: untreated caries increment
timeFrame: 36 months
Secondary outcomes:
measure: caries experience (deft)
timeFrame: 36 months
measure: caries experience for the most affected one third (SIC index)
timeFrame: 36 months
measure: care index
timeFrame: 36 months
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Khartoum Centre for Research and Medical Training
Study officials:
References:
Clinical trial NCT02042352: PNA FISH, PCR and Gram Staining for Detection of Bacterial Vaginosis - a Comparative Clinical Study in a Danish IVF Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Vaginosis
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 195
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: IVF patients

Brief summary: The primary aim of the present study is to investigate the vaginal microbiota of infertile women with two novel molecular based diagnostic tests for Bacterial Vaginosis, a PNA FISH and a PCR method supported with conventional Gram staining.

We hypothesize that the molecular based tests will prove more efficient than conventional Gram staining and that they have a place in future IVF diagnostics.

Detailed description: Our first aim is to investigate the prevalence of altered vaginal microbiotas among women seeking fertility treatment in Denmark. Secondly we want to establish whether there are correlations between altered vaginal microbiotas and self-measurements of both the vaginal pH performed with the Saling pH glove™ and a self-collected swab with Copan Eswab™ because these would be useful for an easy-access longitudinal screening option. Finally, the third aim was to explore how the species composition of vaginal microbiotas measured by a multiplex qPCR assay was reflected in Nugent scores.

A possible 4th aim is to identify patterns in the relative abundances of different species with 16sRNA primers among fertile women compared with infertile women because these differences could be indicative of a vaginal microbiota associated with bad fertility outcome.

Eligibility criteria: Inclusion Criteria:

* Seeking IVF treatment

Exclusion Criteria:

* Bleeding and sexual intercourse within 24h

Primary outcomes:
measure: Cost-benefit analysis of the molecular tests to conventional Gram staining
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: The Fertility Clinic Skive
Study officials:
References:
citation: Jakobsen RR, Haahr T, Humaidan P, Jensen JS, Kot WP, Castro-Mejia JL, Deng L, Leser TD, Nielsen DS. Characterization of the Vaginal DNA Virome in Health and Dysbiosis. Viruses. 2020 Oct 9;12(10):1143. doi: 10.3390/v12101143.
citation: Haahr T, Humaidan P, Elbaek HO, Alsbjerg B, Laursen RJ, Rygaard K, Johannesen TB, Andersen PS, Ng KL, Jensen JS. Vaginal Microbiota and In Vitro Fertilization Outcomes: Development of a Simple Diagnostic Tool to Predict Patients at Risk of a Poor Reproductive Outcome. J Infect Dis. 2019 May 5;219(11):1809-1817. doi: 10.1093/infdis/jiy744.
citation: Haahr T, Jensen JS, Thomsen L, Duus L, Rygaard K, Humaidan P. Abnormal vaginal microbiota may be associated with poor reproductive outcomes: a prospective study in IVF patients. Hum Reprod. 2016 Apr;31(4):795-803. doi: 10.1093/humrep/dew026. Epub 2016 Feb 23.
Clinical trial NCT04856852: Iodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma
Official title: Iodine-125 Brachytherapy Together With Chemotherapy Compared With Surgical Resection Followed by Concomitant Radiochemotherapy in Patients With Newly Diagnosed Glioblastoma，a Randomized, Open-label, Multi-center Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glioblastoma
Keywords: Glioblastoma
Iodine-125
Surgical resection
Radiochemotherapy
Chemotherapy
Radiation
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in patients with newly diagnosed glioblastoma.

Detailed description: This is a prospective, multicentric open-label trial to evaluate the efficacy and safety of Iodine-125 brachytherapy together with chemotherapy compared with surgical resection followed by concomitant radiochemotherapy in patients with newly diagnosed glioblastoma.

The primary efficacy outcome was evaluated with progression-free survival (PFS).

Eligibility criteria: Inclusion Criteria:

* 1. Diagnosis of glioblastoma confirmed by histology
* 2. Age: 18-75 years old
* 3. Single lesion located in one hemisphere with a diameter between 2 and 6 centimeters
* 4. No prior anticancer therapy for glioblastoma besides biopsy.
* 5. ECOG PS：0-2 point

Exclusion Criteria:

* 1. Infra-tentorial tumor or tumor involves the ependymal surface.
* 2. Nonmeasurable disease.
* 3. Evidence of uncontrolled intracranial pressure.
* 4. Severe heart, brain, and lung diseases.
* 5.Severe hepatic or renal dysfunction.
* 6. Uncontrolled, active infection.
* 7. Severe clotting dysfunction.
* 8. Pregnant.
* 9. Uncontrolled hypertension.
* 10. Participated in any other clinical treatment trial within 4 weeks before randomization.
* 11. Severe vascular diseases within 6 months before randomization.
* 12. Participants who received major surgical treatment within 4 weeks or were expected to be treated during the trial.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 2.5 years after randomization
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 2.5 years after randomization
measure: Survival rates at 6 months and 1 year
timeFrame: at 6 months and 1 year after operation respectively
measure: EORTC QLQ-C30
timeFrame: 2.5 year after randomization
measure: ECOG Performance Status
timeFrame: 2.5 year after randomization
measure: Complications
timeFrame: within 1 week after operation
Other outcomes:
Locations:
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Xiaokun Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02479152: The Haemodynamic Effects of Mechanical Standard and Active Chest Compression-decompression During Out-of-hospital CPR
Official title: The Haemodynamic Effects of Mechanical Standard and Active External Chest Compression-decompression During Out-of-hospital Cardiopulmonary Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Mechanical CPR
Hemodynamics
Lead sponsor: Physio-Control
Sponsor class: INDUSTRY
Collaborators: name: GE Healthcare
First posted: 2015-06-24
Enrollment: 126
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: The aim of this randomized out-of-hospital cardiopulmonary resuscitation study is to investigate haemodynamics generated by the standard mechanical external chest compression device (LUCAS™ 2) compared to a new version generating chest compressions and active decompression above the initial starting position of the suction cup (LUCAS™ 2AD).

Detailed description: Based on randomization patients will receive standard or active compression decompression chest compression and the haemodynamic effects will be compared.

Eligibility criteria: Inclusion Criteria:

* Unexpected adult out-of-hospital non-traumatic cardiac arrest where an attempt of resuscitation is considered appropriate in:
* Patients 18 years or older

Exclusion Criteria:

* Traumatic cardiac arrest
* Age believed to be less than 18 years
* Known pregnancy
* Victim not to be resuscitated (DNR orders)
* Internals in prison
* Included once in the study already
* To Small/Large patients
* Sustained ROSC occurring before the LUCAS™ 2 or LUCAS™ 2-AD can be applied to the patient, such that further CPR is not needed

Primary outcomes:
measure: Hemodynamics measured as EtCO2
timeFrame: During 30 minutes of CPR
Secondary outcomes:
measure: Intra arterial blood pressures,
timeFrame: During 30 minutes of CPR
measure: Oximetry,
timeFrame: During 30 minutes of CPR
measure: ROSC (Return of spontaneous circulation)
timeFrame: During CPR
measure: safety
timeFrame: During 30 minutes of CPR
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University hospital
Study officials:
affiliation: Oslo Universitetssykehus. Ullevål, Norway.
name: Lars Wik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berve PO, Hardig BM, Skalhegg T, Kongsgaard H, Kramer-Johansen J, Wik L. Mechanical active compression-decompression versus standard mechanical cardiopulmonary resuscitation: A randomised haemodynamic out-of-hospital cardiac arrest study. Resuscitation. 2022 Jan;170:1-10. doi: 10.1016/j.resuscitation.2021.10.026. Epub 2021 Oct 25.
Clinical trial NCT01279252: CLL Empirical Antibiotic Regimen
Official title: A Phase II Trial of Broad Spectrum Antibiotic Therapy for Early Stage, Non-progressive Chronic Lymphocytic Leukaemia Without Adverse Prognostic Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukaemia (CLL)
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 71
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: The purpose of this study is to evaluate whether patients with previously untreated, early stage CLL respond to empirical broad spectrum antibiotics and therefore test the hypothesis that occult bacterial infections are involved in the induction and maintenance of CLL.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* ECOG performance status of 2 or less.
* CLL with a diagnostic score of 4 or 5.
* Clinical stage A disease.
* No disease progression over a minimum of 1 month prior to commencement of therapy.
* Less than 2 adverse prognostic factors.
* Absence of adverse cytogenetics.
* Expected survival \> 6 months.
* Able to give informed consent.
* No clinical evidence of active infection at the time of study entry.
* No known allergy to any of the study medications.
* Renal and liver function tests within normal limits.

Exclusion Criteria:

* Disease progression during screening period.
* Known positivity for HIV types 1 or 2.
* Active infection at the time of screening.
* Pregnancy or lactation.
* Females of childbearing potential† and males not willing to practice an effective method of contraception whilst receiving the antibiotic regimen and for 4 weeks after the last dose.
* Concomitant medication likely to produce serious interaction with study drugs including warfarin type oral anticoagulants and anti-epileptics.

Primary outcomes:
measure: Overall response rate [Complete Remission (CR) + Partial Remission (PR)]
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of CTCAE grade 2 or above treatment related toxicity
timeFrame: From day 1 to 6 weeks
measure: Bone marrow Minimal Residual Disease (MRD) status in patients who achieve CR
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
affiliation: King's College Hospital NHS Trust
name: Stephen Devereux, PhD, FRCP, FRCPath
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05488652: Cerebromicrovascular Effects of Time-Restricted Eating in Older Adults
Official title: Cerebromicrovascular Effects of Time-Restricted Eating in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Time Restricted Eating
Keywords: Time restricted eating
Intermittent fasting
neurovascular coupling
cognitive function
aging
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The central hypothesis of this study is that closer adherence to time restricted eating (TRE) will improve endothelial function, neurovascular (NVC) responses, resulting in improved cognitive performance, potentially through activation of SIRT1-dependent vasoprotective pathways.

Detailed description: This hypothesis will be tested by assessing the effect of TRE (not more than 10hr eating window each day for 6 months) in healthy adults (≥21 years of age). The group of subjects enrolled into TRE arm will be compared to control group. All participants will be randomized into either arm of the study.

Eligibility criteria: Inclusion Criteria:

-Healthy adults ≥21 years of age

Exclusion Criteria:

-Inability to read or write in English

Primary outcomes:
measure: Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)
timeFrame: baseline, up to 6 months
measure: Change in neurovascular coupling using transcranial Doppler
timeFrame: baseline, up to 6 months
measure: Change in neurovascular coupling using the dynamic retinal vessel analysis
timeFrame: baseline, up to 6 months
Secondary outcomes:
measure: Change in microvascular endothelial function
timeFrame: baseline, up to 6 months
measure: Change in macrovascular endothelial function
timeFrame: baseline, up to 6 months
measure: Change in deep tissue oxygen saturation
timeFrame: baseline, up to 6 months
measure: Change in arterial stiffness
timeFrame: baseline, up to 6 months
measure: Change in ECG
timeFrame: baseline, up to 6 months
measure: Change in Glycocalyx - perfused boundary region
timeFrame: baseline, up to 6 months
measure: Change in capillary density
timeFrame: baseline, up to 6 months
measure: Change in red blood cell velocity
timeFrame: baseline, up to 6 months
measure: Change in Attention
timeFrame: baseline, up to 6 months
measure: Change in Episodic Memory
timeFrame: baseline, up to 6 months
measure: Change in Working Memory
timeFrame: baseline, up to 6 months
measure: Change in Language
timeFrame: baseline, up to 6 months
measure: Change in Executive Function
timeFrame: baseline, up to 6 months
measure: Change in Processing Speed
timeFrame: baseline, up to 6 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Stefano Tarantini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06409052: Endometrial Cancer, Risk Factors and Prevention Strategies: Perspectives of Patients and At-Risk Women
Official title: Endometrial Cancer, Risk Factors and Prevention Strategies: Perspectives of Patients and At-Risk Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with or without a diagnosis of endometrial cancer or endometrial hyperplasia

Brief summary: To learn more about women's attitudes toward and knowledge about endometrial cancer and options that might decrease the risk of developing

Detailed description: To obtain pilot data regarding women's attitudes and perspectives about endometrial cancer and potential endometrial cancer prevention strategies.

Eligibility criteria: Inclusion Criteria:

1. Women who present to MD Anderson Cancer Center including MDA Houston Area Locations with a diagnosis of endometrial cancer
2. Women who present to MD Anderson Cancer Center including MDA Houston Area Locations with a diagnosis of abnormal uterine bleeding or endometrial hyperplasia
3. Women without a diagnosis of endometrial cancer or endometrial hyperplasia
4. Women must be at least 18 years or age
5. Women must be able to read, write, and speak English
6. Women must be willing and able to provide written informed consent

Exclusion Criteria:

Primary outcomes:
measure: Patient education
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Larissa Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00952952: Trial of Mesalamine for the Treatment of Active Microscopic Colitis
Official title: A Randomized, Dose Ranging Trial of Mesalmine for the Treatment of Active Microscopic Colitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Microscopic Colitis
Diarrhea
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Paul E. Evans MD
name: William J. Sandborn MD
name: Edward V. Loftus MD
name: Thomas C. Smryk MD
name: Willaim Tremaine MD
First posted: 2009-08-06
Enrollment: 70
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: Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Pregnant or nursing females are excluded. They can't have other untreated diarrheal conditions. Subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects will be monitored weekly. A pathologist will review pre and post treatment biopsies. Subjects that show improvement will be followed for 4 weeks post medication.

Detailed description: We propose a prospective, randomized trial of mesalamine at 1.2g and 4.8g doses for the treatment of microscopic colitis. Our hypothesis is mesalamine is safe and effective for the treatment of diarrhea in microscopic colitis and that the 4.8g dose is more effective than the 1.2g dose.

We will recruit 70 subjects. The subjects will be randomized into to two groups, 4.8g dose, and 1.2g dose groups. Subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects will be monitored weekly. A pathologist will review pre and post treatment biopsies. Responders will be followed for 4 weeks post medication.

Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Subjects will be excluded if they have unsuccessful treatment or side effects to 5-ASA drugs, oral corticosteroids, or salicylate. and antibiotics, mesalamine, bismuth or steroid use in the last two weeks. Subjects may not be on anticholinergics, cholestyramine, digoxin. Pregnant or nursing females are excluded. They can't have other untreated diarrheal conditions.

A two-sample z-score test for proportions will be used to test whether relief rates are different between groups.

Eligibility criteria: Inclusion Criteria:

* Subjects must be 18 years old and older.
* Have diarrhea and microscopic colitis.
* They need to have a colon biopsy done at the Mayo Clinic in Rochester, MN within a year of enrollment.

Exclusion Criteria:

* None.

Primary outcomes:
measure: To determine the efficacy of mesalamine at 1.2g and 4.8g doses in microscopic colitis for providing relief of diarrhea
Secondary outcomes:
measure: To compare the safety and tolerability of mesalamine at 1.2g and 4.8g doses in patients with microscopic colitis.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: