louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00906347: A Trial of Oral Misoprostol for Labor Augmentation
Official title: A Randomized, Controlled Trial of Oral Misoprostol for Labor Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor Augmentation
Keywords: Labor augmentation
Oral misoprostol
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 350
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.


Eligibility criteria: Inclusion Criteria:

* Clinical decision to augment labor
* Gestational age \> than or equal to 36 weeks
* Singleton gestation
* Cephalic presentation
* Reassuring fetal heart rate tracing
* Cervical dilation between 4 and 8 cm
* Ruptured membranes with clear amniotic fluid
* Intrauterine pressure catheter in place
* Less than 200 MVUs in a 10 minute period
* 5 or fewer contractions in a 10 minute period
* English or Spanish speaking patient

Exclusion Criteria:

* Non-reassuring fetal heart rate tracing at time of enrollment
* Meconium stained amniotic fluid
* Previous uterine incision
* Maternal fever (defined as greater than 37.9 C)
* Known fetal anomalies
* Placenta previa or unexplained vaginal bleeding
* Estimated fetal weight of 4,500 grams or more
* Abnormal maternal bony pelvis
* Grandmultiparity

Primary outcomes:
measure: Uterine Tachysystole
timeFrame: Up to four hours after administration of study drug
Secondary outcomes:
measure: Infant Apgar Score <4
timeFrame: 5 minutes after delivery
measure: Umbilical Cord Artery pH <7.1
timeFrame: Obtained at delivery
measure: Admission of Neonatal Intensive Care Unit
timeFrame: Until hospital discharge
measure: Maternal Chorioamnionitis
timeFrame: During labor
measure: Maternal Hypovolemia Requiring Blood Transfusion
timeFrame: Until hospital discharge
measure: Method of Delivery
timeFrame: At delivery
measure: Time Elapsed From Start of Labor Augmentation to Delivery
timeFrame: Initiation of augmentation until delivery
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: April Bleich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Kenneth Leveno, MD
role: STUDY_DIRECTOR
References:
citation: Bleich AT, Villano KS, Lo JY, Alexander JM, McIntire DD, Leveno KJ. Oral misoprostol for labor augmentation: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1255-1260. doi: 10.1097/AOG.0b013e318236df5b.
Clinical trial NCT03410147: A Dose-finding and Feasibility Study for a Prolonged 13C-octanoate Breath Test for Gastric Emptying
Official title: A Dose-finding and Feasibility Study for a Prolonged 13C-octanoate Breath Test for Gastric Emptying During Continuous Nutrient Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Gastric Emptying
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A single blind, randomized, crossover monocentric study in a cohort of adult healthy volunteers
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this dose-finding and feasibility study is to establish the optimal 13C-octanoate concentration to be used with slowly infused enteral nutrition to perform a prolonged gastric emptying test using the breath test. More specifically, the aim is to discover the 13C-octanoate concentration that induces a steady state hourly 13C-recovery. This would allow to implement the prolonged breath test protocol in a future clinical investigation in critically ill patients.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* At least 18 years old
* BMI between and including 18 and 29
* Understand and able to read Dutch
* In good health on the basis of medical history
* Refrains from herbal, vitamin and other dietary supplements on the day of the visits

Exclusion Criteria:

* Dyspeptic symptoms (assessed with PAGI-SYM questionnaire, Annex II)
* Using any medication that might affect gastric function or visceral sensitivity
* Known / suspected current use of illicit drugs
* Known psychiatric or neurological illness
* Any gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
* History of heart or vascular diseases like irregular heartbeats, angina or heart attack
* Nasopharyngeal surgery in the last 30 days
* Suspected basal skull fracture or severe maxillofacial trauma
* History of thermal or chemical injury to upper respiratory tract or esophagus
* Current esophageal or nasopharyngeal obstruction
* Known coagulopathy
* Known esophageal varices
* Have a known allergy or intolerance to cow milk, soy or any other ingredient of Isosource Standard.
* Known galactosaemia

Primary outcomes:
measure: Hourly 13C-recovery
timeFrame: 8 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT00379847: An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
Official title: A 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyponatremia
Keywords: hyponatremia
hypervolemic
euvolemic
treatment outcomes
YM087
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 251
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 study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.


Eligibility criteria: Inclusion Criteria:

* Serum sodium levels less than or equal 130mEq/L
* Euvolemic or Hypervolemic hyponatremia

Exclusion Criteria:

* Clinical evidence of volume depletion or dehydration
* Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
* Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment

Primary outcomes:
measure: Baseline-adjusted change in AUC for serum sodium
timeFrame: 96 Hours
Secondary outcomes:
measure: Comparison of safety between patients in each study arm
timeFrame: 96 Hours
Other outcomes:
Locations:
city: Tuscon
country: United States
state: Arizona
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Augusta
country: United States
state: Georgia
city: Petoskey
country: United States
state: Michigan
city: Cincinnati
country: United States
state: Ohio
city: Columbia
country: United States
state: South Carolina
city: Afula
country: Israel
city: Ashkelon
country: Israel
city: Hadera
country: Israel
city: Haifa
country: Israel
facility: 2 Sites
city: Holon
country: Israel
city: Jerusalem
country: Israel
facility: 2 Sites
city: Nahariya
country: Israel
city: Rechovot
country: Israel
city: Safed
country: Israel
facility: 2 Sites
city: Tel-Aviv
country: Israel
city: Zerifin
country: Israel
city: Amanzimototi
country: South Africa
city: Bellville
country: South Africa
city: Bloemfontein
country: South Africa
city: Durban
country: South Africa
facility: 2 Sites
city: Johannesburg
country: South Africa
facility: 4 Sites
city: Krugersdorp
country: South Africa
city: Lyttelton
country: South Africa
city: Pretoria
country: South Africa
city: Somerset West
country: South Africa
city: Soweto
country: South Africa
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Art Wheeler, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02831647: Acceptability and Tolerance Study of New Oral Nutritional Supplement PRAGUE
Official title: Tolerance and Acceptability of AYMES PRAGUE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Aymes International Limited
Sponsor class: INDUSTRY
Collaborators: name: Eat Well Now
First posted: 2016-07-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Tolerance and Acceptability of new oral nutritional supplement - AYMES PRAGUE

Detailed description: To evaluate tolerance and acceptability of AYMES PRAGUE in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference,convenience etc.

To obtain data to support an ACBS submissions for AYMES PRAGUE (to allow for prescription in the community at NHS expense).

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
* Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/day
* Patients expected to require oral nutritional supplementation for at least 2 further weeks.
* Informed consent obtained.

Exclusion Criteria:

* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Patients requiring a milk-free diet
* Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
* Patients with significant renal or hepatic impairment
* Patients with swallowing impairment requiring thickened fluids
* Patients with inflammatory bowel disease or previous bowel resection.

Primary outcomes:
measure: GI side effects when using AYMES PRAGUE
timeFrame: 9 DAYS
Secondary outcomes:
measure: Change to bodyweight of subjects when using AYMES PRAGUE
timeFrame: 9 days
measure: Compliance with prescription of AYMES PRAGUE
timeFrame: 9 days
measure: Bowel habits of subjects when using AYMES PRAGUE - frequency
timeFrame: 9 days
measure: Bowel habits of subjects when using AYMES PRAGUE - stool consistency
timeFrame: 9 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03723577: An Evaluation of a Fibrillar Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Official title: A Case Series Evaluating a Fibrillar Collagen Powder Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wound
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2018-10-29
Enrollment: 0
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: Patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. The powder dressing will be used in accordance with its label. After cleansing the wound by the clinical site staff, the powder is placed directly on the wound, and then the wound will be covered with an appropriate moisture retentive secondary dressing. Patients will visit the clinic twice a week to have the powder re-applied. Wound evaluations will take place once a week at the outpatient clinic, with the intervention lasting up to twelve weeks. Concurrent standard of care, such as compression for venous ulcers, will be provided.


Eligibility criteria: Inclusion Criteria:

* Has one of the following types of wounds below the knee: diabetic ulcers, pressure ulcers, venous ulcers, ulcers of mixed-vascular origin, traumatic wounds, or post-surgical wounds
* Wound has been present for at least four weeks
* Wound is free of necrotic tissue or debridement practices will take place prior to initial visit in order to remove necrotic tissue
* Wound has failed at least one wound care treatment
* Wound size is between 1 and 100 square centimeters
* Patient has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, measured within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index greater than 0.8 and no worse than mild disease on segmental pressures.
* Wound is confirmed as being free of infection and absence of osteomyelitis

Exclusion Criteria:

* Pregnant, planning to become pregnant during the study timeframe, or breast feeding
* Unable or unwilling to receive porcine collagen
* Wound is infected or presence of osteomyelitis
* Allergy or sensitivity to collagen
* Inability, in the opinion of the Investigator to follow protocol requirements, attend follow up visits in a timely manner, or otherwise comply with the requirements of the protocol

Primary outcomes:
measure: Change in wound size over twelve week period
timeFrame: Baseline to 84 days
Secondary outcomes:
measure: Change in Bates-Jensen Wound Assessment Tool
timeFrame: Baseline to 84 days
measure: Change in reported pain level
timeFrame: Baseline to 84 days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Valley Foot and Ankle Specialty Providers
state: California
Study officials:
affiliation: Valley Foot and Ankle Specialty Providers
name: Emmy Oji, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002377: A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cytomegalovirus Retinitis
HIV Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of RS-79070 when used as induction therapy in patients with newly diagnosed peripheral retinitis. To assess the effects of induction and maintenance level dosing of RS-79070 on CMV viral load, estimated by plasma CMV PCR. To assess the pharmacokinetics of ganciclovir following administration of RS-79070 in the target population.


Eligibility criteria: Inclusion Criteria:

* Documented AIDS diagnosis
* Newly diagnosed peripheral CMV retinitis
* More than 3 weeks of previous therapy for CMV retinitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Univ of California / Irvine
state: California
city: La Jolla
country: United States
facility: Univ of California / San Diego / Dept of Pediatrics
state: California
city: San Diego
country: United States
facility: Univ of California / San Diego Treatment Ctr
state: California
city: San Francisco
country: United States
facility: Davies Med Ctr / Institute for HIV Research
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Med Ctr
state: California
city: San Francisco
country: United States
facility: QUEST Clinical Research
state: California
city: Washington, D.C.
country: United States
facility: Dr Alan Palestine
state: District of Columbia
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Emory Eye Clinic
state: Georgia
city: Boston
country: United States
facility: New England Med Ctr
state: Massachusetts
city: New York
country: United States
facility: New York Univ Med Ctr
state: New York
city: New York
country: United States
facility: St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
state: New York
city: New York
country: United States
facility: New York Hosp - Cornell Med Ctr
state: New York
city: Durham
country: United States
facility: Duke Univ Eye Ctr
state: North Carolina
city: Austin
country: United States
facility: Austin Infectious Disease Consultants
state: Texas
city: Vancouver
country: Canada
facility: St Pauls Hosp
state: British Columbia
city: Toronto
country: Canada
facility: The Toronto Hosp / Dept of Infectious Disease
state: Ontario
city: Montreal
country: Canada
facility: Montreal Chest Institute
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hosp
state: Quebec
Study officials:
References:
Clinical trial NCT02722577: EGM Analysis in Idiopathic Outflow Tract Ventricular Arrhythmia
Official title: Usefulness of Unipolar and Bipolar Electrograms in Predicting Successful Ablation Site During Idiopathic Outflow Tract Ventricular Arrhythmia Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Outflow Tract Tachycardia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-03-30
Enrollment: 20
Sex: ALL
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: 20 patients meeting the inclusion and exclusion criteria

Brief summary: Investigate the value of unipolar and bipolar electrograms (EGM) for predicting the successful ablation site for idiopathic outflow tract ventricular arrhythmia (OTVA).

Detailed description: The proposed study aims to evaluate the predictive value of using reversed polarity in adjacent bipolar EGMs (bi-RP method) and unipolar EGM with QS morphology (uni-QS method) for identifying successful ablation site, and evaluate the feasibility of enhancing uni-QS method's performance by using its morphology characteristics such as descending slope and symmetry.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo ablation for idiopathic OTVA
* Have the ability to provide informed consent for study participation.

Exclusion Criteria:

* Be currently participating in any other investigational study
* Be less than 18 years of age
* Be pregnant
* Has any other conditions that are not suitable for catheter ablation (including but are not limited to active whole-body infection or sepsis, coagulation or hemorrhage disorder history)

Primary outcomes:
measure: Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery
timeFrame: Intraoperative, an average of 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Guodong Niu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03511677: Insole on Morton's Neuroma
Official title: Effectiveness of Insole on Morton's Neuroma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morton Neuroma
Keywords: Insole
Morton Neuroma
Pain
Function
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2018-04-30
Enrollment: 72
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: Objective: The aim of the present study was to assess the effectiveness of insole with metatarsal support on pain in patients with Morton's neuroma and the impact of this insole on function, load distribution in the plantar region, gait variables, quality of life and satisfaction with insole use.

Methods: A randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. Seventy-two patients with Morton's neuroma were randomly allocated into a study group and control group. One week following the baseline evaluation, the study group received insole with metatarsal support made of ethyl vinyl acetate and the control group received a flat insole of the same material, color and density. The groups were evaluated after 6, 12 and 24 weeks of insole use. The following assessment parameters employed: pain when walking and at rest (END); quality of life (SF-36); foot function (FFI and FHSQ); six-minute walk test (6MWT) and foot pressure analysis using the AM Cube FootWalk Pro program.


Eligibility criteria: Inclusion Criteria:

* Patient with clinical and radiological diagnosis (magnetic resonance or ultrasound) of Morton's neuroma.
* Pain in the foot with VAS between 3-8 cm to walk.
* Over 18 years.
* No distinction of sex
* Agree to participate of the study and sign the informed consent form.

Exclusion Criteria:

* Other symptomatic musculoskeletal diseases in MMII.
* Symptomatic diseases of the central and peripheral nervous system.
* Diabetes Mellitus.
* Rigid deformities on foot.
* Use of insoles in the last three months.
* Physiotherapy in the last three months.
* Infiltrations on foot and ankles in the last three months.
* Previous or expected surgery in the next twelve months.
* Allergy to the material of the insole.
* Mental deficiency.
* Geographic inaccessibility .- Use of corticosteroids or NSAIDs in the last month

Primary outcomes:
measure: Change in pain
timeFrame: Baseline, after 6, 12 and 24 weeks
Secondary outcomes:
measure: Change in function and foot health
timeFrame: Baseline, after 6, 12 and 24 weeks
measure: Change in function, foot healt and quality of life
timeFrame: Baseline, after 6, 12 and 24 weeks
measure: Change in function
timeFrame: Baseline, after 6, 12 and 24 weeks
measure: Quality of life
timeFrame: Baseline, after 6, 12 and 24 weeks
Other outcomes:
Locations:
Study officials:
References: