louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02044068: Hepatitis B Virus Vertical Transmission From HIV-HBV Co-infected Women
Official title: Prevention of Hepatitis B Virus Mother-to-Child Transmission (MTCT) From HIV-HBV Co-infected Pregnant Women by Use of Nucleosides/Nucleotides Analogues With Dual Activity During Pregnancy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertical Disease Transmission
HBV
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 35
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children born in the Maternity Department, Lariboisiere Hospital, Paris, France, from HIV-HBV co-infected women

Brief summary: Vertical HIV transmission has been dramatically reduced by the use of combined antiretroviral therapy in HIV-infected pregnant women. Among the most often used drugs, several have dual activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir. Studies about vertical HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The study hypothesis is a major reduction of the risk of HBV vertical transmission.

Detailed description: Mother-to-Child HIV transmission has been dramatically reduced by the use of combined antiretroviral therapy in HIV-infected pregnant women, both in developed and in developing countries. Among the most often used drugs, several have dual activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir; they can be used as a combo, as tenofovir+emtricitabine for instance. Studies about vertical HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The study hypothesis is a major reduction of the risk of HBV vertical transmission in this context, justifying this retrospective study.

Eligibility criteria: Inclusion Criteria:

* children born in the Maternity Department from HIV-HBV co-infected women
* whose mother was given a treatment with dual activity (HIV and HBV) during pregnancy

Exclusion Criteria:

* no

Primary outcomes:
measure: Hepatitis B sAg status in children born from HIV-Hepatitis B Virus co-infected women
timeFrame: up to 10 years (expected average: 5 years)
Secondary outcomes:
measure: Antibodies (Ab) against Hepatitis B core antigen in children
timeFrame: up to 10 years (expected average: 5 years)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Lariboisiere
Study officials:
affiliation: Hopital Lariboisiere, Paris, France
name: Pierre O SELLIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sellier PO, Schnepf N, Amarsy R, Maylin S, Lopes A, Mazeron MC, Flateau C, Morgand M, Ciraru-Vigneron N, Berthe A, Simoneau G, Evans J, Souak S, Matheron S, Benifla JL, Simon F, Bergmann JF. Short article: Hepatitis B virus status in children born to HIV/HBV coinfected women in a French hospital: a cross-sectional study. Eur J Gastroenterol Hepatol. 2016 Mar;28(3):328-32. doi: 10.1097/MEG.0000000000000559.
Clinical trial NCT00564668: Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 Diabetes
Official title: A 24-week, Randomised, Multi-centre, Double-blind, Parallel-group Trial to Investigate the Safety and the Efficacy of NN2000-Mix30 Compared to NN-X14Mix30 NovoRapid®30Mix) in Subjects With Type 2 Diabetes Mellitus on a Twice Daily Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-11-28
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: This trial is conducted in Japan. The aim of this trial was to investigate the safety and efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced by current process in Japanese subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes
* Subjects with insulin treatment for at least 24 weeks
* Current treatment with premixed biphasic human insulin preparation for at least 12 weeks
* HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

* Recurrent severe hypoglycaemia
* Proliferative retinopathy or maculopathy requiring acute treatment
* Impaired renal function
* Cardiac diseases
* Uncontrolled hypertension
* Subjects with known malignant tumour
* Total daily insulin dose greater than or equal to 100 IU

Primary outcomes:
measure: Safety
timeFrame: During 24 weeks of treatment
Secondary outcomes:
measure: HbA1c
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03067168: A Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.
Official title: A Multicenter, Double Blinded, Randomized Controlled Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: The Christ Hospital
Sponsor class: OTHER
Collaborators: name: The University of Kansas Medical Center
First posted: 2017-03-01
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if levator muscle block with bupivacaine improves postoperative pain control relative to placebo controls among women undergoing prolapse surgery involving a posterior colporrhaphy. Improvement is defined as no less than a 25% lower total pain score on a ten point numerical pain scale.


Eligibility criteria: Inclusion Criteria:

* Any woman over the age of 18 years with a capacity to give informed consent who are undergoing vaginal prolapse surgery including a posterior colporrhaphy may be included in the study.

Exclusion Criteria:

* Any woman who is a non-English speaker, does not have ability to provide consent, has a cardiac arrhythmia, liver disease, myasthenia gravis, bleeding diathesis or adverse reaction / allergy to anesthetic will be excluded. Women that are also having vaginal mesh excisions at the time of prolapse repair or those that will undergo subsequent surgery in the follow up period will be excluded.

Primary outcomes:
measure: Number of patients with improvement in pain, scored on a 10 point numerical pain scale.
timeFrame: 1 year
Secondary outcomes:
measure: Postoperative care satisfaction scores, graded with a post-operative survey.
timeFrame: 1 year
measure: Measure of morphine equivalents used in patients postoperatively.
timeFrame: 1 year
measure: Length of hospital stay measured in hours.
timeFrame: 1 year
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo
state: Ohio
Study officials:
affiliation: The Christ Hospital
name: Carson T Kaeser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaeser CT, Rothenberger R, Zoorob D, Whiteside JL. Bupivacaine Use After Posterior Colporrhaphy to Reduce Postoperative Pain: A Multicenter, Double-Blinded, Placebo-Controlled, Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2022 Feb 1;28(2):72-76. doi: 10.1097/SPV.0000000000001082.
Clinical trial NCT01971268: Compare the Success Rate of T3 Dental Implant (Biomet 3I) With or Without Platform-switch Concept
Official title: Marginal Bone Behavior of Dental Implants to Different Rehabilitation Protocols
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Implants
Bone Loss
Keywords: T3 dental implants
Marginal bone loss
Survival rate
Lead sponsor: Implantology Institute
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population from a private office who seek care to replace missing teeth, must have economical status to do implant supported rehabilitations

Brief summary: In patients that received a T3 (Biomet 3I) dental implant, does the use of platform-switch concept compared to the use of platform-matched concept, refrain marginal bone loss during osseointegration phase (t=12 weeks =T1) and from then to final rehabilitation (t= placement of the final restoration = at 18 weeks=T2)

Detailed description: Patients from a private practice who received dental implants (T3 dental implant Biomet 3I) from November 2012 to October 2013 were eligible to enter the study.

Two groups were formed: one group received a T3 dental implant with platform switch concept and the other received an implant with platform matched type of connection.

We evaluate osseointegration at T1 (12 weeks) and marginal bone position in relation to the implant platform at baseline (implant installation) T0 and again at T1 and T2.

From data recorder in T0,T1 and T2, we evaluate changes in marginal bone position.

Eligibility criteria: Inclusion Criteria:

* Single unit implant rehabilitation
* Maxilla and mandible
* Biomet 3I T3 dental implant placed
* Final Rehabilitation placed

Exclusion Criteria:

* Immediate implants
* Radiographic impossibility of measure
* Absence of baseline T0 radiograph
* Smoking habits (more 10 cigarets a day)
* Diabetes
* Patients who receive Radio or/and Chemotherapy

Primary outcomes:
measure: Position of Implant Platform to marginal bone
timeFrame: At Baseline (T0)
measure: Marginal Bone Position at 8 Weeks
timeFrame: At 12 weeks (T1) after Baseline
measure: Marginal Bone Position at 12 Weeks
timeFrame: At 18 Weeks (T2) after baseline (T0)
Secondary outcomes:
measure: Osseointegration
timeFrame: At 12 weeks
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Instituto de Implantologia
Study officials:
affiliation: Implantology Institute
name: Andre Chen, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Implantology Institute
name: João Caramês, Phd
role: STUDY_DIRECTOR
affiliation: Implantology Institute
name: Helena Francisco, Msc
role: STUDY_CHAIR
affiliation: Implantology Institute
name: Elena Cervino, Msc
role: STUDY_CHAIR
References:
Clinical trial NCT02226068: Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis
Official title: Ciclosporine and Extracorporal Photopheresis (ECP) Are Equipotent in Treating Severe Atopic Dermatitis (AD): A Randomized Cross-over Study Comparing Two Efficient Treatment Modalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Ciclosporine
Extracorporal photopheresis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-08-26
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but potential side effects are concerning. Several reports point at extracorporeal photopheresis (ECP) as an efficient alternative treatment modality with few and mild side effects. However, no direct comparison between CsA and ECP in the treatment of AD has been performed so far. In this trial we test the hypothesis that ECP is non-inferior to standard treatment with CsA.


Eligibility criteria: Inclusion Criteria:

Criteria of inclusion were refractoriness to standard topical treatment (corticosteroid ointments, UVA, UVB, PUVA, tar).

Exclusion Criteria:

Criteria of exclusion were pregnancy, uncontrolled hypertension, previous malignancy, infectious disease, liver/kidney disease or active treatment with ECP or immunosuppressants within 4 weeks prior to start of trial.

Primary outcomes:
measure: Change of SCORAD (SCORing Atopic Dermatitis)
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark
name: Erik Obitz, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04859868: Non-pharmaceutical Motion Sickness Mitigation
Official title: Non-pharmaceutical Motion Sickness Mitigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects attend four visits of the experiment on four separate days. Each visit will be an hour and a half long. In the first visit, subjects will perform batteries of tests that involve balance, cognition, and determine motion perception at different current levels using a rotating chair. In the next three visits, researchers will test the Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair be either turning stimulation ON from beginning, or middle or by not turning ON (the order will be randomized).
Primary purpose: PREVENTION

Brief summary: The purpose of this study is evaluate the effect of timing and magnitude on the administration of our nonpharmaceutical treatment to motion sickness, and to evaluate the effect of Galvanic Vestibular Stimulation (GVR) amplitude on functional fitness task performance.


Eligibility criteria: Inclusion Criteria:

* Must be able to consent to participate themselves.
* Must be able to attend in-person sessions at the Mayo Aerospace Medicine and Vestibular Research Laboratory in Scottsdale, AZ.
* No racial ethnic groups will be excluded.
* Must be fluent speakers of English.

Exclusion Criteria:

* History of vestibular disease, migraine, or significant balance disorder.
* Traumatic brain injury.
* Recent middle ear infection or recent motion sickness (within 72 hours).
* History of severe motion sensitivity.
* Women who are pregnant.

Primary outcomes:
measure: Motion Perception
timeFrame: During the rotation of the chair, approximately 1 hr
Secondary outcomes:
measure: Motion Sickness Questionnaire
timeFrame: During the rotation of the chair, approximately 1 hr
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Gaurav N Pradhan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01516268: The Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane Block to Reduce the Narcotic Dosage and Pain After Cesarean Delivery
Official title: the Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane (TAP) Block Under the Guide of Ultrasound to Reduce the Narcotic Dosage, Side Effects and Pain in the First 24 Hours After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Cesarean Delivery
TAP block
sufentanyl
Narcotic dosages
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound guide can reduce narcotic dosage, side effects and pain after cesarean delivery.


Eligibility criteria: Inclusion Criteria:

* female 18 to 40 Years
* class ASA 1 and 2
* candidates for elective cesarean section

Exclusion Criteria:

* renal failure
* liver failure
* cardiac disorder
* coagulopathy
* hepatomegaly
* splenomegaly
* drug sensitivity and abuse
* morbid obesity
* smoking
* history of post operative nausea and vomiting
* motion sickness
* local hypoesthesia

Primary outcomes:
measure: Narcotic Dosage
timeFrame: 24 h
measure: Narcotic Dosage
timeFrame: over 24 hours after surgery
Secondary outcomes:
measure: Pain
timeFrame: 24h
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati hospital, TUMS
Study officials:
affiliation: TUMS, Tehran University of Medical Sciences
name: Laleh Eslamian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00672672: Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients
Official title: Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wounds
Infection
Keywords: surgical site healing treated with autologous platlet gel
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2008-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will determine if autologous platelet gel (APG) on sternal incision and conduit sites will improve wound healing and decrease infection in coronary artery bypass grafting surgery patients.

Detailed description: The purpose of this study is to determine if the use of autologous platelet gel (APG) on sternal incision and conduit sites will improve wound healing and decrease the incidence of infection in patients undergoing coronary artery bypass grafting surgery

Eligibility criteria: Inclusion Criteria:

* Any patient who meets criteria and consents to undergo a CABG procedure involving conduit sites and consents to this study.

Exclusion Criteria:

* Any patient, after inclusion, whom is later determined to have had on-going therapy that could influence wound healing such as radiation or chemotherapy, extensive steroid use, or accidental trauma such as burns, etc.

Primary outcomes:
measure: Healing and infection of surgical sites
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Ali Khoynezhad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00269672: Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects
Official title: A Randomized, Open Label, Controlled Phase II Study to Evaluate Safety, Tolerability and Immunogenicity After Two Different 13-Valent Pneumococcal Conjugate Vaccine Formulations in Elderly Subjects Aged 65 Years and Older Who Are Naive to Previous 23vPS Immunization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Keywords: vaccine
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 915
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is evidence that aluminum phosphate (AlPO4) contained as an adjuvant in conjugate vaccines enhances the immune response in infants. There is no data so far evaluating whether this also applies to adults. The objective of this study is to compare the immune response of 2 different 13-valent pneumococcal conjugate (13vPnC) formulations with and without AlPO4 to select a formulation and to compare the immune response to the chosen 13vPnC formulation relative to the immune response to 23-valent pneumococcal polysaccharide vaccine (23vPS).


Eligibility criteria: Inclusion Criteria:

* Male and female adults 65 years of age and older.
* Determined by medical history, physical examination, and clinical judgment to be eligible for the study.
* Expected to be available for the duration of the trial (up to approximately 13 months).

Exclusion Criteria:

* Received previous immunization with 23vPS.
* Serious chronic disorders including metastatic malignancy
* Known or suspected hypersensitivity to any vaccine or vaccine components

Primary outcomes:
measure: Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation.
Secondary outcomes:
measure: Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by IgG).
measure: Safety and tolerability of the selected 13vPnC formulation given 12 months after a previous dose of the selected 13vPnC.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Juergens C, de Villiers PJ, Moodley K, Jayawardene D, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23-valent pneumococcal polysaccharide vaccine in elderly adults: a randomized open-label trial. Hum Vaccin Immunother. 2014;10(5):1343-53. doi: 10.4161/hv.27998. Epub 2014 Feb 27.