louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00344058: Abbreviated MgSO4 Therapy in Post-partum Preeclampsia
Official title: Abbreviated Post-partum Magnesium Sulfate Seizure Prophylaxis in Preeclampsia: A Comparison of 12 and 24 Hour Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Preeclampsia
Keywords: pregnancy
preeclampsia
treatment
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2006-06-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Magnesium sulfate is used for seizure prophylaxis in pregnancies complicated by preeclampsia. There is debate as to how long to continue this therapy after delivery of the pregnancy. Different schemes have been offered to shorten the exposure to magnesium sulfate after delivery, with little data. We seek to investigate the effect of shortened magnesium sulfate therapy on the post-partum recovery phase of mild preeclampsia. Our hypothesis was that shortened therapy (12 hours versus the traditional 24 hours post-partum) has no effect on disease course, and will result in significantly shorter exposure to magnesium sulfate.

Detailed description: The study has been completed at this time.

Consenting women with suspected mild preeclampsia (new onset/exacerbated hypertension with proteinuria) were randomly assigned 12 (12-hour) or 24-hours (24-hour) of postpartum MgSO4. Treatment was continued beyond the initially assigned time period for new findings of severe preeclampsia. Clinical and laboratory data were collected. Analysis was by intent to treat, utilizing Fisher's exact, chi-square, and Student's t-tests where appropriate

Eligibility criteria: Inclusion Criteria:

* Women with suspected mild preeclampsia diagnosed antepartum, intrapartum, or post-partum were eligible for inclusion after delivery at term (≥ 34 weeks' gestational age).

Exclusion Criteria:

* Inability to give informed consent, preterm delivery, severe preeclampsia

Primary outcomes:
measure: Time of magnesium sulfate therapy (minutes)
measure: Blood pressure
measure: Maternal symptoms (headaches, blurred vision, chest pain, shortness of breath)
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center, Labor and Delivery
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center at Case Western Reserve School of Medicine
name: Hugh M Ehrenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ehrenberg HM, Mercer BM. Abbreviated postpartum magnesium sulfate therapy for women with mild preeclampsia: a randomized controlled trial. Obstet Gynecol. 2006 Oct;108(4):833-8. doi: 10.1097/01.AOG.0000236493.35347.d8.
Clinical trial NCT04555863: haMSter: a Novel Smartphone Communication Tool for People With MS
Official title: haMSter: a Novel Smartphone Communication Tool for People With MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: M-health
Multiple Sclerosis
Keywords: m-health
multiple sclerosis
patient reported outcomes
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: haMSter is a smartphone app that tracks validated patient reported outcome measures (PROMs) in people multiple sclerosis (MS). In this study, 50 patients with MS will receive this app for 6 months and be asked to fill out the PRO questionnaires on their Smartphone.

Endpoints include the adherence to this app and satisfaction with this Intervention.


Eligibility criteria: Inclusion Criteria:

* Any MS according to MacDonald criteria
* informed consent

Exclusion Criteria:

- language barriers

Primary outcomes:
measure: adherence to device
timeFrame: over the course of this study (over 6 months)
Secondary outcomes:
measure: Overall satisfaction with this application in telemedicine
timeFrame: after study completion (after 6 months)
measure: General satisfaction with specific Features of the haMSter app
timeFrame: after study completion (after 6 months)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
citation: Altmann P, Ponleitner M, Monschein T, Krajnc N, Zulehner G, Zrzavy T, Leutmezer F, Rommer PS, Kornek B, Berger T, Bsteh G. Feasibility of a smartphone app to monitor patient reported outcomes in multiple sclerosis: The haMSter interventional trial. Digit Health. 2022 Nov 4;8:20552076221135387. doi: 10.1177/20552076221135387. eCollection 2022 Jan-Dec.
citation: Altmann P, Hinterberger W, Leutmezer F, Ponleitner M, Monschein T, Zrzavy T, Zulehner G, Kornek B, Lanzenberger R, Berek K, Rommer PS, Berger T, Bsteh G. The Smartphone App haMSter for Tracking Patient-Reported Outcomes in People With Multiple Sclerosis: Protocol for a Pilot Study. JMIR Res Protoc. 2021 May 7;10(5):e25011. doi: 10.2196/25011.
Clinical trial NCT04632563: Prevalence of Musculoskeletal Symptoms in the Cambridge NIHR BioResource
Official title: Prevalence of Musculoskeletal Symptoms in the Cambridge NIHR BioResource
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Musculoskeletal Diseases
Musculoskeletal Injury
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2020-11-17
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All members of the Cambridge NIHR BioResource

Brief summary: Musculoskeletal diseases, such as osteoarthritis, represent a large proportion of the global burden of disease with hip and knee osteoarthritis alone being the 11th greatest cause of disease burden.

The purpose of this study is to determine the level of musculoskeletal symptoms in members of the Cambridge National Institute for Health Research (NIHR) BioResource and see if this is associated with their possession of genetic markers that have been identified as being associated with osteoarthritis.

This will allow us to determine the real level of musculoskeletal symptoms in this large cohort of volunteers and provide basic information that could be used to facilitate further musculoskeletal research in the NIHR BioResource population.

Detailed description: All active members of the Cambridge NIHR BioResource will be approached.

They will be sent an email outlining the purpose of the study and asking that if they would like to take part to please complete the online questionnaire which will be linked to in the email.

For those individuals who agree to participate and complete the questionnaire, the Cambridge NIHR BioResource will provide the genetic marker information it already holds for specific markers that are known to be associated with osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* Member of the NIHR BioResource
* Willing to consent to participate

Exclusion Criteria:

* Previous self-report of osteoarthritis on joining BioResource

Primary outcomes:
measure: MSK Symptom Levels
timeFrame: 3 months
measure: Osteoarthritis genetic marker
timeFrame: 6 months
Secondary outcomes:
measure: MSK Cohort
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Cambridge
name: Andrew McCaskie
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00941863: Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)
Official title: Phase I Study to Determine the Safety, Maximum Tolerated Dose, PK of BAY43-9006 in Repeated Cycles of 18 Days On/3 Days Off in Combination With Paclitaxel and Carboplatin Chemotherapy in Patients With Advanced, Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma
Keywords: Sorafenib
Advanced Solid Tumors
Maximum tolerated dose
Carboplatin and paclitaxel chemotherapy combination
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2009-07-20
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors.

The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these patients being treated with sorafenib in combination with paclitaxel and carboplatin.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed solid tumors
* Evaluable disease
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Life expectancy minimum 12 weeks

Exclusion Criteria:

* Congestive heart failure
* Serious arrhythmias
* Coronary artery disease (CAD) or ischemia
* HIV (human immunodeficiency virus)
* Hepatitis B or C
* Serious active infection
* Metastatic brain or meningeal tumors

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin
timeFrame: 21 days
measure: Participants With Hematological and Biochemical Toxicities
timeFrame: Start of treatment until death or within 14 days last study drug intake
Secondary outcomes:
measure: Tumor Response
timeFrame: From start of treatment until progression or death occurs assessed every 6 weeks.
measure: Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) Start From Day 2 of Cycle 1
timeFrame: At day 2 in study
measure: Maximum Concentration (CMAX) Start From Day 2 of Cycle 1
timeFrame: At day 2 in study
measure: Time of Maximum Concentration (TMAX) Start From Day 2 of Cycle 1
timeFrame: At day 2 in study
Other outcomes:
measure: Serious Adverse Events
timeFrame: From start of treatment until 18 Sep 2008, up to 6 years
measure: Other Adverse Events
timeFrame: From start of treatment until 18 Sep 2008, up to 6 years
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00541463: A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients (0639-112)(COMPLETED)
Official title: A Multicenter, Open-Label, Randomized, Study to Compare the Efficacy and Safety of Indinavir 800 mg b.i.d. Plus Ritonavir 100 mg b.i.d. Plus Two NRTIs vs. Nelfinavir 1250 mg b.i.d. Plus Two NRTIs in HIV-1 Seropositive Patients Who Have Failed or Are Intolerant to an NNRTI Containing Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV
Treatment Experienced
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 330
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: A study comparing Indinavir plus Ritonavir plus 2 NRTIs vs. Nelfinavir 1250 plus two nucleoside reverse transcriptase inhibitors (NRTIs) in the treatment of HIV positive patients who have not responded to or are intolerant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) containing treatment.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* HIV positive
* No active heart disease

Exclusion Criteria:

* Pregnant or breast feeding
* Unwilling to use birth control or abstinence to prevent pregnancy
* Received an investigational drug or vaccine within the past 30 days or is planning to receive other investigational study drug/vaccine or interferon while in the study
* Plan to receive NNRTIs while in the study
* Received therapy which lowers body's ability to fight infection within the past 30 days or while in the study
* Alcohol or substance abuse
* Hepatitis

Primary outcomes:
measure: Plasma viral RNA levels will be measured at predetermined time points to determine mean change
Secondary outcomes:
measure: CD4 cell counts will be measured at predetermined time points to determine change from baseline
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00181363: Prone Breast Irradiation for Pendulous Breasts
Official title: Mamma Board Project: Prone Breast Irradiation for Pendulous Breasts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Breast conserving surgery
Radiotherapy
Pendulous breasts
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2005-09-16
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We hypothesize that for large pendulous breasts, breast irradiation in supine and prone position are equivalent with regard to coverage of the PTV, but with a better dose homogeneity in prone position and a smaller radiation exposure of lung and heart.The purpose of this study is to compare the 3-D dose distribution in PTV(Planning Target Volume) and normal tissues in prone position versus supine position.

Detailed description: Local excision followed by adjuvant radiotherapy has become standard treatment for women with early-stage breast cancer. Adjuvant radiotherapy may encounter technical difficulties in patients with pendulous breasts when treated in supine position.

Based upon literature and our own preliminary experiences, we hypothesize that for large pendulous breasts, breast irradiation in supine and prone position are equivalent with regard to coverage of the PTV, but with a better dose homogeneity in prone position and a smaller radiation exposure of lung and heart. However, no quantitative data are yet available to test this hypothesis. Therefore, the aim of our study is to compare the 3-D dose distribution in PTV and normal tissues in prone position versus supine position. For treatment in prone-position an in-house developed device, the "mammaboard" was used.

Eligibility criteria: Inclusion Criteria:

* Patients should have had breast-conserving surgery for breast cancer or DCIS (Ductal Carcinoma in Situ)
* No indication for radiotherapy of regional nodes
* Large, pendulous breasts (bra size D and over)

Exclusion Criteria:

* Regional radiotherapy is indicated
* Unable to lie in prone position

Primary outcomes:
measure: Dose Homogeneity 1: PTV
timeFrame: 1 day after treatment planning
measure: Dose Homogeneity 2: V105% and V107%
timeFrame: 1 day after treatment planning
measure: Dose Homogeneity 3: V95 %
timeFrame: 1 day after treatment planning
Secondary outcomes:
measure: PTV Coverage in Organs at Risk: MLD (Gy)
timeFrame: during treatment planning
measure: PTV Coverage in Organs at Risk: Heart V30
timeFrame: during treatment planning
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Maastricht Radiation Oncology
state: Limburg
Study officials:
affiliation: Maastricht Radiation Oncology
name: Jeroen Buijsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01533363: Study About Patient Comfort and Long-term Outcome After Stapled Hemorrhoidopexy
Official title: Patient Comfort After Stapled Hemorrhoidopexy Long Term Results of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Internal Hemorrhoids
Keywords: Hemorrhoids
Surgery
Hemorrhoidopexy
Milligan Morgan
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the influence on Patient comfort after Stapled Hemorrhoidopexy versus Milligan Morgan (two surgical procedures)in third degree circular hemorrhoids.

Detailed description: There are well known advantages in the short-outcome, however, there are still some uncertainties about the long-term results and recurrence rates, and only a few data of randomized trials are available.

In most studies the patient population was heterogeneous with a varied degree of treated hemorrhoids, and different surgical procedures were performed. Therefore we initiated this prospective randomized controlled study of a homogeneous patient population with only circular third-degree hemorrhoids and clearly defined operative procedures. All patients with symptomatic, reducible circular third-degree hemorrhoidal disease were randomly assigned to undergo either the Milligan-Morgan technique or the stapling procedure. Patients were excluded from the study if they had single third-degree hemorrhoids, acute incarcerated hemorrhoids, intercurrent acute anal fissure and/or acute anal fistula, or prior hemorrhoidectomy. The main end point parameter of this study was to compare both groups with respect to patient comfort and postoperative pain. Secondary end points included the long-term recurrence rate of hemorrhoidal disease after a minimum of 4 years.

Eligibility criteria: Inclusion Criteria:

* third degree circular hemorrhoids
* symptomatic
* reducible

Exclusion Criteria:

* single third-degree hemorrhoids
* acute incarcerated hemorrhoids
* intercurrent acute anal fissure
* acute anal fistula
* prior hemorrhoidectomy.

Primary outcomes:
measure: Postoperative Pain
timeFrame: within the first 30 days after surgery
Secondary outcomes:
measure: long-term recurrence rate
timeFrame: up to 5 years after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Surgery, Martinistreet 52, University Hospital Hamburg Eppendorf, 20246 Hamburg
name: Jakob R Izbicki, MD
role: STUDY_CHAIR
References:
citation: Gravie JF, Lehur PA, Huten N, Papillon M, Fantoli M, Descottes B, Pessaux P, Arnaud JP. Stapled hemorrhoidopexy versus milligan-morgan hemorrhoidectomy: a prospective, randomized, multicenter trial with 2-year postoperative follow up. Ann Surg. 2005 Jul;242(1):29-35. doi: 10.1097/01.sla.0000169570.64579.31.
Clinical trial NCT04867863: SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Dental Caries
Keywords: celiac disease
children
caries
HLA DQ2
HLA DQ8
screening
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
Collaborators: name: FONDAZIONE CARIVERONA
name: Azienda ULSS di Verona e Provincia
First posted: 2021-04-30
Enrollment: 4570
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 5-10 years

Brief summary: The main aim of the study is to currently define the prevalence of celiac disease (CD) in children aged 5-10 years in 2 Italian cities (Ancona and Verona). The screening protocol is based on a 1st line genetic test (searche of HLA DQ2/DQ8 genotypes) followed by a serological diagnosis (IgA TTG and IgG DGP).

Detailed description: All scholar children aged 5-10 years living in the cities of Ancona and Verona will be invited to partecipate. Children enrolled will be investigated as follows:

1. HLA DQ2/DQ8 genotyping (by a rapid test)
2. In children genetically predisposed to CD serological investigations will be performed (both IgA TTG and IgG DGP antibodies)
3. The overall population will be evaluated for the prevalence and severity of dental caries (by using the DMFT/dmft index)

Eligibility criteria: Inclusion Criteria: age 5-10 -

Exclusion Criteria: celiac disease, on a gluten free diet

-

Primary outcomes:
measure: prevalence of celiac serology in children aged 5-10
timeFrame: 2 years
Secondary outcomes:
measure: prevalence of dental caries in children genetically predisposed to CD in comparison with children not predisposed
timeFrame: 2 years
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Department of Pediatrics Universita' Politecnica Delle Marche
Study officials:
References:
Clinical trial NCT00534963: Optimal Catheter Placement During Sonohysterography: Comparison of Cervical to Uterine Placement
Official title: Optimal Catheter Placement During Sonohysterography: A Randomized Clinical Trial Comparing Cervical to Uterine Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Placement and Perceived Pain
Keywords: sonohysterography, catheter placement
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 69
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this investigation was to evaluate if the location of placement of the SIS balloon into either the uterine cavity or the cervical canal affected discomfort perceived during the examination.

Detailed description: The use of sonography combined with intrauterine saline instillation, termed sonohysterography

Eligibility criteria: Inclusion Criteria:

* Female patients undergoing SIS for diagnostic uterine cavity evaluation at our university's Reproductive Endocrine Infertility Program.

Exclusion Criteria:

* previous hysterectomy, current pregnancy, active PID, patulous or stenotic cervical os noted on previous history or physical exam.

Primary outcomes:
measure: Measure: perceived discomfort
timeFrame: during sonohysterography procedure
Secondary outcomes:
measure: Measure: Time required to perform procedure; Measure: Volume of media required to perform procedure
timeFrame: during sonohysterography procedure
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin Department of Reproductive Endocrinology and Infertility
name: Steven Lindheim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spieldoch RL, Winter TC, Schouweiler C, Ansay S, Evans MD, Lindheim SR. Optimal catheter placement during sonohysterography: a randomized controlled trial comparing cervical to uterine placement. Obstet Gynecol. 2008 Jan;111(1):15-21. doi: 10.1097/01.AOG.0000295865.93719.3f.