louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00324818: Treatment of Bacterial Vaginosis
Official title: Therapy and Prevention for Sexually Associated Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Vaginosis
Keywords: bacterial vaginosis
treatment
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2006-05-11
Enrollment: 600
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: We are trying to determine if longer duration of therapy with metronidazole or combination therapy of metronidazole plus azithromycin results in better cure rates for BV

Detailed description: Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of BV has been advocated for decreasing the prevalence of these complications. The etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Further, half of all women who meet the clinical diagnostic criteria for BV are asymptomatic and treatment of these women remains controversial. More detailed characterization of the origins, natural history and response to therapy would supply data to guide control efforts. We will approach these problems through a multifaceted interdisciplinary evaluation of women with and without BV.

The specific aims {and hypotheses} of this project are:

1. To conduct studies to determine optimal agents and duration of therapy for BV {Hypothesis: Longer duration of therapy and combination therapy will result in higher cure rates and lower recurrence rates of BV; response to therapy differs between women with asymptomatic BV and symptomatic BV}
2. To examine the role of condoms in the prevention of BV {Hypothesis: BV is a sexually transmitted infection, thus recurrence rates of BV will be lower among women with higher condom usage rates}
3. To further explore the role of Mobiluncus spp., organisms strongly associated with the syndrome, by utilizing specimens derived from the above studies.

{Hypothesis: Mobiluncus is involved in the pathogenesis of BV at least in a subset of women, and the persistence of this organism is associated with lack of cure and recurrence of BV}

Eligibility criteria: Inclusion Criteria:

* Symptomatic bacterial vaginosis

Exclusion Criteria:

* Pregnancy
* Other genital infections

Primary outcomes:
measure: cure of bacterial vaginosis (BV)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Jefferson County Department of Health STD Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jane Schwebke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04375618: RhEGF Incorporated in An Absorbable Collagen Membrane for The Management Of Gingival Recession Defects
Official title: Efficacy of Recombinant Human Epidermal Growth Factor (RhEGF) Incorporated in An Absorbable Collagen Membrane for The Management of Gingival Recession Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Periodontitis
Keywords: epidermal growth factor
gingival recession
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.

Detailed description: IN TEST SITE :

Local anesthesia will be administered and Vertical incisions will be given at interdental papillae away from recession defect site and a pouch will be created. A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.

IN CONTROL SITE:

Same procedure will be done as the test site but plain collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy male and female patients of age 20-55 yrs with Millers class I or class II gingival recession are included in the study.

Exclusion Criteria:

* Patients who are medically compromised and Subjects who underwent radiotherapy or chemotherapy and who are Smokers are excluded from the study

Primary outcomes:
measure: Recession depth (RD)
timeFrame: Base line to 6months.
Secondary outcomes:
measure: Width of keratinized gingiva (KGW)
timeFrame: Base line to 6months.
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: R V Chandra
state: Telangana
Study officials:
References:
Clinical trial NCT06581718: Eye Gaze Technology for Endoscopic Inspection of the Gastrointestinal Tract
Official title: Eye Gaze Technology for Endoscopic Inspection of the Gastrointestinal Tract
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Gi
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Robotic controlled endoscopy of GI tract.

Detailed description: A robotised conventional endoscope will be used to examine the GI tract of 10 patients following successful benchtop trials.

Eligibility criteria: Inclusion Criteria:

* Routine UGI endoscopic indications

Exclusion Criteria:

* Varices
* \<18
* GI haemorrhage
* PS \> 2

Primary outcomes:
measure: Time of completion
timeFrame: 6 months
measure: User Experience survey
timeFrame: 6 months
measure: Patient Experience survey
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
state: Lonodon
Study officials:
References:
Clinical trial NCT03871218: Effect of Hyaluronic-acid on the Healing After Free Gingival Graft
Official title: Evaluation of the Effect of Hyaluronic Acid Application on the Healing of the Donor and Recipient Sites After Free Gingival Graft With Laser Doppler Flowmetry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gingival Recession
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After FGG was taken from the donor region in the TG, sterile gauze was applied with moderate pressure for 2 minutes, and HA was applied topically after the bleeding stopped. In the TG, HA was applied to the entire recipient bed before suturing the graft taken from the palatial mucosa to the recipient site. In the control group (CG), HA was not applied to the recipient or the donor site.
Primary purpose: TREATMENT

Brief summary: This study evaluated the effect of topical hyaluronic acid (HA) application on free gingival graft (FGG) donor and recipient sites during the early wound healing period with laser Doppler flowmetry (LDF) and to investigate the effect of HA application on the dimensional change of the graft.Participants were randomly classified into the test group (TG) and control group (CG). HA was applied to both donor and recipient sites in 20 patients who formed the TG, whereas HA was not applied to the 20 patients who formed the CG.

Detailed description: The healing of a transplanted tissue depends on the formation of blood support between the donor and recipient sites.

Hyaluronic acid (HA) is a biomaterial that creates a favorable environment for wound healing due to its unique hydroscopic and viscoelastic properties, and it is important for wound healing activities.HA induces angiogenesis following degradation and improves the wound healing environment.HA supports a mechanism that induces proliferation of capillaries, and components produced after HA degradation increase vascularization.Laser Doppler flowmetry (LDF) technique is frequently used in the field of plastic surgery for monitoring microvascular blood flow to detect insufficient circulation in the skin transplants and flaps in the early period and to thereby prevent and predict possible surgical complications.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed inadequate attached gingiva

Exclusion Criteria:

* Smoking

Primary outcomes:
measure: blood perfusion value in the recipient bed
timeFrame: on day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Dentistry Department of Periodontology
state: Çankaya
Study officials:
affiliation: Gazi University
name: Zeynep Turgut Çankaya
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002118: An Open-Label Safety Program for the Use of Zalcitabine (Dideoxycytidine; ddC) in Pediatric Patients With Symptomatic HIV Infection Who Have Failed or Are Intolerant to AZT Monotherapy, or Who Have Completed Other ddC Protocols, or Are Ineligible for Other Ongoing Clinical Studies
Official title: An Open-Label Safety Program for the Use of Zalcitabine (Dideoxycytidine; ddC) in Pediatric Patients With Symptomatic HIV Infection Who Have Failed or Are Intolerant to AZT Monotherapy, or Who Have Completed Other ddC Protocols, or Are Ineligible for Other Ongoing Clinical Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Zalcitabine
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 600
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To allow, on a compassionate use basis, zalcitabine (ddC) for pediatric patients with symptomatic HIV disease who have failed treatment or who are intolerant to zidovudine (AZT), or who have completed other ddC protocols, or who are ineligible for ongoing clinical trials.

Detailed description: Patients receive ddC and are evaluated at study entry and every 3 months thereafter, until 3 months after ddC becomes approved for pediatric patients or the sponsor deems it necessary to terminate the protocol.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Symptomatic HIV infection.
* Failure on or intolerance to AZT monotherapy OR completed other ddC protocols OR been ineligible for other ongoing clinical trials.
* Consent of parent or guardian required.

Note:

* Patients who do not meet the eligibility requirements may discuss their cases with the medical monitor.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nutley
country: United States
facility: Hoffmann - La Roche Inc
state: New Jersey
Study officials:
References:
citation: Adkins JC, Peters DH, Faulds D. Zalcitabine. An update of its pharmacodynamic and pharmacokinetic properties and clinical efficacy in the management of HIV infection. Drugs. 1997 Jun;53(6):1054-80. doi: 10.2165/00003495-199753060-00009.
Clinical trial NCT02621918: The Effects of Exercise in End-stage Renal Disease Patients Undergoing Hemodialysis
Official title: The Effects of an Intradialytic Progressive Resistance and Aerobic Training in End-stage Renal Disease Patients Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Failure on Dialysis
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We aimed to investigate the effect of a progressive resistance training and aerobic training protocol on functional capacity, body composition and quality of life.

Detailed description: Subjects were randomized into group A and B: group A (n=30) exercised for the first 6 months while group B (n=31) performed a placebo exercise initially (3 months) and cross-over to aerobic exercised for 3 months more.

Eligibility criteria: Inclusion Criteria:

* older than 18 years
* more than three months of hemodialysis vintage
* under the permission of their nephrologist
* agreement to be randomly assigned and undergo study protocols

Exclusion Criteria:

* Patients in wheelchair, presenting disability, or those who had amputation and malformation of the lower limbs, causing impaired walking
* presenting representative blindness

Primary outcomes:
measure: Body composition by Dual-energy x-ray absorptiometry (DEXA)
timeFrame: before and after 12 and 24 weeks of study
Secondary outcomes:
measure: Quality of life assessed by the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)
timeFrame: before and after 12 and 24 weeks of study
measure: Functional capacity
timeFrame: before and after 12 and 24 weeks of study
measure: Pulmonary capacity
timeFrame: before and after 12 and 24 weeks of study. Additionally this variable was assessed over the three time points before and after one hemodialysis session.
Other outcomes:
Locations:
Study officials:
References:
citation: Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
Clinical trial NCT03707418: Bivalirudin vs Heparin in ECMO Patients
Official title: A Randomized Study Comparing Bivalirudin vs Heparin in Patients With Extracorporeal Membrane Oxygenator (ECMO) Support
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Extracorporeal Membrane Oxygenation Complication
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 0
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 an open label, randomized study comparing the clinical outcomes of unfractionated Heparin and Bivalirudin for anticoagulation in adult subjects requiring ECMO support.

Detailed description: This open label randomized study will compare the clinical outcomes of patients on ECMO who are anticoagulated with Heparin and Bivalirudin. Patients will be anticoagulated with a heparin bolus at the commencement of ECMO per standard of care, as there will be insufficient time to randomize these frequently emergent patients. Consent for the study will be obtained from a legally authorized representative Prior to starting a continuous infusion of maintenance anticoagulation, patients will be randomized to bivalirudin or heparin. Outcome measures are bleeding, thrombosis, development of Heparin Induced thrombocytopenia, number of cross-overs between the two research arms, circuit failures, decannulation, deaths and discharges from hospital.

Eligibility criteria: Inclusion Criteria:

* Adult patients on veno-arterial (VA) or veno-venous (VV)ECMO

Exclusion Criteria:

* Patient or surrogate decision makers cannot provide informed consent.
* Patients who have intolerance to either heparin or bivalirudin
* Patients who received any form of thrombolytic therapy within the past 30 days.

Primary outcomes:
measure: Number of heparin-induced thrombocytopenia (HIT) events
timeFrame: 30 days
measure: Number of Cross-overs between arms
timeFrame: 30 days
measure: Number of circuit failures requiring a circuit exchange
timeFrame: 30 days
measure: Thrombotic events
timeFrame: 30 days
measure: Bleeding events
timeFrame: 30 days
measure: Renal failure
timeFrame: 30 days
measure: Number of Transfusions
timeFrame: 30 days
measure: Number of emergent decannulations
timeFrame: 30 days
measure: Number of patients surviving to discharge
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Glenn Whitman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hasegawa D, Sato R, Prasitlumkum N, Nishida K, Keaton B, Acquah SO, Im Lee Y. Comparison of Bivalirudin Versus Heparin for Anticoagulation During Extracorporeal Membrane Oxygenation. ASAIO J. 2023 Apr 1;69(4):396-401. doi: 10.1097/MAT.0000000000001814. Epub 2022 Apr 10.
Clinical trial NCT01207713: A Modified Orbital Implantation Technique in Enucleation
Official title: Evaluation of the Functional and Cosmetic Outcome of Enucleation With Rectus End-to-end Suturing Surgical Technique in Coralline Hydroxyapatite Orbital Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orbital Implants
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2010-09-23
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 73
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who had received hydroxyapatite orbital implants after primary enucleation by a single surgeon from July 2005 to March 2009

Brief summary: To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end suturing surgical technique in hydroxyapatite orbital implants

Detailed description: To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end suturing surgical technique between 2005 and 2009. All the patients underwent primary enucleation and implantation of non-wrapped HA implants using a technique that involves drawing the ends of the rectus muscles anteriorly and suturing them into a cross-shape in front of the implant. Main outcome measures included occurrence of pain or discharge, soft tissue problems, implant motility, upper lid position, and patients' satisfaction.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

bilateral enucleation severely traumatized orbits, and little or no function of the extraocular muscles adjunctive radiotherapy and/or chemotherapy diabetes vessel inflammation follow-up of less than 6 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: second affiliated hospital,zhejiang university
name: Juan Ye, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00315913: Trial of Oxytocin Alone Versus Oxytocin and Propranolol for the Treatment of Abnormal Labor
Official title: Placebo-Controlled Randomized Trial of Oxytocin Alone Versus Oxytocin and Propranolol for the Treatment of Dysfunctional Labor
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Dysfunctional Labor
Keywords: Labor
Dysfunctional Labor
Labor Arrest
Primary Cesarean Section Prevention
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2006-04-19
Enrollment: 0
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: The purpose of this study is to determine whether propranolol is better than oxytocin for the treatment of labor abnormalities. The endpoint is the rate of vaginal delivery experienced by women receiving prolonged oxytocin versus propranolol.

Detailed description: This trial was designed to test if propranolo can reduce the c section rate for dysfuctional labor. Due to stringent inclution and exclusion criteria and low enrollment the study was closed.

Eligibility criteria: Inclusion Criteria:

* Must be term pregnancy (\> 37 weeks)
* Vertex presentation
* Active labor (4-5 centimeters dilated)

Exclusion Criteria:

* Heart disease
* Diabetes
* Currently taking propranolol
* Contraindications to labor or vaginal delivery
* Multiple gestations
* Preterm
* Chorioamnionitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Leah R Battista, MD
role: PRINCIPAL_INVESTIGATOR
References: