louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03990441: Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) Versus Placebo During the First Stage of Labor
Official title: Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) Versus Placebo During the First Stage of Labor. Double-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcutaneous Electric Nerve Stimulation
Labor Pain
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario de Castellón
First posted: 2019-06-19
Enrollment: 46
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: This study seeks to verify the analgesic efficacy of TENS during the first stage of labor applying TENS parameters that, according to with the evidence, can be effective for this application and discarding the placebo effect according to the methodological recommendations.

Detailed description: TENS is a non-pharmacological alternative for pain control during labor. Although it's a method that has been used for decades, there is not enough evidence on its efficacy, so it's considered ineffective in the Spanish and British guidelines of clinical practice. The present study seeks to verify the analgesic efficacy of TENS by applying the electrodes in the spinal nerve roots associated with labor pain and using conventional TENS with parameters that, according to the evidence, may be effective for this application.

Eligibility criteria: Inclusion Criteria:

- Women attending routinary fetal monitoring before labor

Exclusion Criteria:

* Multiparous
* Scheduled cesarean
* Implantable Cardioverter Defibrillator (ICD) or pacemaker
* Epilepsy
* Fetal malformation
* Language barrier

Primary outcomes:
measure: Pain intensity measure
timeFrame: Start of intervention, each 30 minutes during intervention, end of intervention (when neuraxial anesthesia is applied -if the woman demands it- or after delivery, assessed up to 10 hours from intervention's start).
Secondary outcomes:
measure: TENS satisfaction
timeFrame: At leaving the labor room, assessed up to 3 hours after delivery.
Other outcomes:
Locations:
city: Castellón De La Plana
country: Spain
facility: Hospital General Universitario de Castellón
state: Castellón
Study officials:
affiliation: Cardenal Herrera University
name: Manuel José Sos Gallén, PT, PGCert
role: STUDY_DIRECTOR
References:
Clinical trial NCT00888641: A Pilot Study of Renal Hypothermia During Partial Nephrectomy
Official title: A Pilot Study of Renal Hypothermia During Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-04-27
Enrollment: 13
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: Renal hypothermia may preserve renal function in patients who require partial nephrectomy. In preparation for a definitive randomized controlled trial this pilot study will assess feasibility and variance data to be used for sample size estimation


Eligibility criteria: Inclusion Criteria:

1. Patients presenting with a renal mass deemed amenable to an open partial nephrectomy regardless of stage or histology.
2. Bilateral renal function on radiographic imaging.
3. Willing to consent to randomization.
4. Willing to comply with study protocol.

Exclusion Criteria:

1. Anatomically or functionally solitary kidney
2. Multiple renal tumours
3. Bilateral renal tumours
4. Life expectancy \< 3 months as deemed by treating physician
5. Age less than 18 years old
6. Pregnancy

Primary outcomes:
measure: measures of renal function uCrCl be performed for estimation of renal function
timeFrame: 3 months
Secondary outcomes:
measure: Post-operative complication
timeFrame: 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT01529541: Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone
Official title: A Multicenter, Randomized, Double-blind, Double Dummy, Active-controlled, Therapeutic Confirmatory Trial(Phase 3) to Evaluate the Efficacy and Safety of CWP-0403 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 DM Insufficiently Controlled With Metformin Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: CWP-0403
Sitagliptin
Metformin
type 2 DM
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled with metformin alone.


Eligibility criteria: Inclusion Criteria:

* Patients who had diagnosed with type 2 DM before 3 months
* Men and women between the age of ≥ 19 and ≤ 75 years
* FPG ≤ 270 mg/dL at screening visit
* Patients who consent to participate in this trial by written Informed Consent Form

Exclusion Criteria:

* Type 1 DM or secondary diabetes
* Subjects who are administrating oral anti-hyperglycemic drugs or have to take a medicine
* Body mass index \< 20 kg/m2 or \> 40.0kg/m2
* Subjects who are assessed to be inappropriate for this trial by investigator

Primary outcomes:
measure: The Change in HbA1c from baseline to week24.
timeFrame: 0wk, 8wk, 16wk, 24wk
Secondary outcomes:
measure: The proportion of subjects achieving HbA1c<7% at week24
timeFrame: 0wk, 8wk, 16wk, 24wk
measure: The proportion of subjects achieving HbA1c<6.5% at week24
timeFrame: 0wk, 8wk, 16wk, 24wk
measure: The change from baseline to week 24: Fasting plasma glucose
timeFrame: 0wk, 24wk
measure: change from baseline to week 24: Fasting serum insulin
timeFrame: 0wk, 24 wk
measure: change from baseline to week 24 in Fasting serum pro-insulin
timeFrame: 0wk, 24wk
measure: change from baseline to week 24 in Fasting serum c-peptide
timeFrame: 0wk, 24wk
measure: change from baseline to week 24 in HOMA-β
timeFrame: 0wk, 24 wk
measure: change from baseline to week 24 in HOMA-IR
timeFrame: 0wk, 24 wk
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
References:
Clinical trial NCT05515341: A DirEct to PatieNt Study in Chronic Pain
Official title: A DirEct to PatieNt Study in Chronic Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Keywords: Chronic Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2022-08-25
Enrollment: 50000
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Chronic pain

Brief summary: To compile real-world, direct from patient clinical outcomes and objective metrics in patients who have received or plan to receive a commercially approved interventional medical device therapy/procedure for chronic pain in routine clinical practice.


Eligibility criteria: Key Inclusion Criteria:

* Patient is planning to receive or has received a commercially approved interventional medical device therapy/procedure to treat chronic pain, ascertained from self-reporting
* Age ≥ 22 years at time of eligibility screening, ascertained by self-reported age at time of eligibility screening
* Proficient in written and spoken English, defined by self-reporting of comfort reading, writing and speaking English

Key Exclusion Criteria:

* Requires a legal representative to sign the ICF ascertained from self-reporting

Primary outcomes:
measure: Change in pain post procedure
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: United States
facility: Boston Scientific Neuromodulation
state: California
Study officials:
affiliation: Boston Scientific Corporation
name: Natalie B Lyons
role: STUDY_DIRECTOR
References:
Clinical trial NCT04194541: Wound Dressings for Hidradenitis Suppurativa
Official title: Wound Dressings for Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hidradenitis Suppurativa
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 28
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 primary purpose of this research is to determine how the types of wound dressings affect quality of life for people with Hidradenitis Suppurativa (HS).


Eligibility criteria: Inclusion Criteria:

* Men and women ≥18 years of age
* Diagnosed with Hidradenitis Suppurativa (all stages of disease) by Dermatologist
* Presence of at least one lesion with active drainage
* Willing and able to provide informed consent

Exclusion Criteria:

* Subjects younger than 18-years-old.
* Prisoners
* Pregnant or lactating women
* Adults unable to consent

Primary outcomes:
measure: Dermatology Life Quality Index (DLQI) Scores
timeFrame: At Baseline, at 6 Weeks
Secondary outcomes:
measure: Average Pain as Assessed by the Numerical Rating Scale (NRS)
timeFrame: At Baseline, at 6 Weeks
measure: Maximal Pain as Assessed by the Numerical Rating Scale (NRS)
timeFrame: At Baseline, at 6 Weeks
measure: Sleep Rating
timeFrame: At Baseline, at 6 Weeks
measure: Drainage Rating
timeFrame: At Baseline, at 6 Weeks
measure: Odor Rating
timeFrame: At Baseline, at 6 Weeks
measure: Number of Participants at Each Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Grading
timeFrame: At 6 Weeks
measure: Average Frequency of Dressing Changes
timeFrame: 6 Weeks
measure: Number of Participants Reporting Overall Dressing Preference for Specific Body Part
timeFrame: At Baseline
measure: Number of Participants Reporting Dressing Preference for Each Specific Body Part
timeFrame: Visit 1 (Day 14)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hadar Lev-Tov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02431741: A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds
Official title: Title: A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Wounds
Keywords: Presence of at least one exuding malignant (fungating) wound in need for antimicrobial treatment
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2015-05-01
Enrollment: 14
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: This is a prospective, open, non-controlled clinical investigation to evaluate the performance and safety of using Mepilex Transfer Ag on a malignant wound. Approximately ten to fifteen (10-15) subjects from one to three centers in Europe, presenting with a malignant (fungating) wound will be enrolled into the study. Eligible subjects will have one malignant (fungating) wound selected as a "study site". Subjects will be followed for a one-week observation period with their existing product followed by a 4-week investigation period using Mepilex Transfer Ag.


Eligibility criteria: Inclusion Criteria:

* Presence of at least one exuding malignant (fungating) wound in need for antimicrobial treatment
* Both genders with an age ≥ 18 years at randomization
* Subjects with a suspected survival time of \> 3 months
* Signed informed consent

Exclusion Criteria:

* Any known or suspected systemic infection
* Use of metronidazole is not allowed during the investigation period
* Any known sensitivity to silver or other components/products used in this study.
* Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
* Participation in another investigational study while participating in this study.

Primary outcomes:
measure: Infection in the Wound (Signs of Clinical Infection)
timeFrame: weekly, for 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Charles University School of Medicine
city: Prague
country: Czech Republic
facility: The General University Hospital in Prague
Study officials:
References:
Clinical trial NCT00935441: Effect of Case-Management Using Home Monitoring on Diabetes and Blood Pressure Outcomes
Official title: Effect of Nurse-Based, Protocol-Driven, Case-Management Utilizing Home Telemonitoring and Home HbA1c Measurement on Diabetes and Blood Pressure Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
chronic care
case management
telemedicine
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2009-07-09
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized trial designed to determine if adoption of the chronic care model in conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can improve glycemic control compared to patients receiving usual case management. We hypothesize that nurse case management, with home telemonitoring of blood sugars and home HbA1c measurement will result in additional improvements in glycemic control compared to isolated nurse case management. Specifically, the telemonitoring group will have an HbA1c 0.5% lower compared to usual nurse case management. Secondary aims include an additional 5 mmHg improvement in systolic blood pressure (among patients with hypertension at the time of enrollment), improved patient satisfaction with treatment, improved medication adherence, reduced incidence of hypoglycemia, and reduced case manager time in the telemonitoring/home HbA1c group compared with usual caes management. The study will enroll 460 diabetic patients with HbA1c values greater than 8.5%, age 75 years or younger, who have a active land-line for telephone communication. Patients will be enrolled and actively case managed for 9 months.


Eligibility criteria: Inclusion Criteria:

* Enrolled at Minneapolis VAMC,
* Type 1 or 2 Diabetes,
* HbA1c \>8.5%,
* active land-line telephone connection

Exclusion Criteria:

* Age \>75 years,
* primary care provider unwilling to have patient enrolled,
* active dialysis,
* resident of assisted living facility,
* research participant in previous diabetes case management study,
* life expectancy \<1 year,
* severe mental health condition,
* active substance abuse,
* pregnant or planning on becoming pregnant

Primary outcomes:
measure: Glycemic control (HbA1c)
timeFrame: 9 months after enrollment
Secondary outcomes:
measure: Systolic blood pressure control in patients with elevated blood pressure at baseline
timeFrame: 9 months after enrollment
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VAMC
state: Minnesota
Study officials:
References:
Clinical trial NCT00368641: Heart Failure and Peritoneal Ultrafiltration
Official title: Treatment-Resistant Heart Failure (HF) and Peritoneal Ultrafiltration (PUF): A Randomized Prospective Trial of Standard Care Versus Standard Care With Peritoneal Ultrafiltration in Patients With Treatment-Resistant Severe Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Congestive Heart Failure
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation (Former Sponsor)
First posted: 2006-08-25
Enrollment: 12
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 objective of the study is to determine if the addition of peritoneal ultrafiltration to standard therapy in treatment-resistant severe heart failure patients will improve fluid balance and functional capacity such that they will spend less time in the hospital and have an improved ambulatory quality of life in comparison to patients who remain on standard therapy alone.


Eligibility criteria: Inclusion Criteria:

* Adults with congestive heart failure (CHF) who remain fluid overloaded despite standard treatment.

Exclusion Criteria:

* Patients who have reversible CHF or have diseases or conditions that would contraindicate the use of peritoneal dialysis.

Primary outcomes:
measure: All-cause Hospitalization (Unadjusted)
timeFrame: 6 to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Evanston
country: United States
state: Illinois
city: Winston-Salem
country: United States
state: North Carolina
city: Melbourne
country: Australia
state: Victoria
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Roeselare
country: Belgium
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
References:
Clinical trial NCT04830241: Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant
Official title: Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant-Analysis of Two Pharmacovigilance Databases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Hypotonia
Antidepressant Drug Adverse Reaction
Pregnancy Related
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 10000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all neonatal hypotonia newborns cases associated with in utero exposure to antidepressant drugs retrived in the two pharmacovigilance database

Brief summary: To better characterize the neonatal hypotonia associated with in utero exposure to antidepressants, so far limited to clinical cases, we will perform an observational retrospective pharmacovigilance study, using two databases. First, disproportionality analysis in Vigibase®, the World Health Organization global database, will be perform between antidepressant drugs and neonatal hypotonia . Second, narratives from the French National Pharmacovigilance Database will be extracted.


Eligibility criteria: Inclusion Criteria:

* neonatal hypotonia newborns cases associated with in utero exposure to antidepressant drugs

Exclusion Criteria:

* Reports with maternal suicide, congenital malformation and hypotonia occurring only during breastfeeding

Primary outcomes:
measure: neonatal hypotonia
timeFrame: Case reported in the World Health Organization (WHO) pharmacovigilance database to April 1st 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Normandy
Study officials:
References:
Clinical trial NCT01888341: Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting Condition
Official title: An Open Label, Randomized, Single Dose, Oral Bioequivalence Study of Isotretinoin Capsules 20 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of ACCUTANE® Capsules 20 mg of Roche Laboratories Inc., Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 41
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions

Detailed description: An open label, randomized, single dose, oral bioequivalence study of Isotretinoin capsules 20 mg of Dr. Reddy's Laboratories Limited,under fasting conditions

Eligibility criteria: Inclusion Criteria:

1. Healthy males between 18 and 45 years of age inclusive.
2. Informed of the nature of the study and given written informed consent.
3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 125 lbs. (Appendix I).

Exclusion Criteria

1. Hypersensitivity to isotretinoin or related compounds.
2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
3. Recent history of mental illness, drug addiction, drug abuse or alcoholism.
4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
5. Received an investigational drug within the 4 weeks prior to study dosing.
6. Currently taking any prescription medication within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
7. Regular tobacco use in the 3 months prior to study dosing.

Primary outcomes:
measure: Area under curve (AUC)
timeFrame: Pre-dose (0) and 0.5, 1,1.5,2,2.5,3,4,5,6,8,10,16,24,36,48,72 and 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Quadrangle Drive, Chapel Hill,
country: United States
facility: AAI
state: North Carolina
Study officials:
affiliation: AAI
name: Dr. Ralph Scallion, MD
role: PRINCIPAL_INVESTIGATOR
References: