louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02883504: Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure
Official title: Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Doppler Echocardiography
Keywords: E/e' ratio
Doppler echocardiography, filling pressure
Left Ventricular end-Diastolic Pressure
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The non-invasive estimation of left ventricular end diastolic pressure (LVeDP) is a main goal for performing an echocardiography in the routine clinical practice. Conflicting evidence exists about mitral E/e' ratio reliability for predicting high LVeDP


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Patient performing an echocardiography in the routine clinical practice
* Informed consent given

Exclusion Criteria:

* Severe valve disease, valvular prostheses, calcification of the mitral valve, the history of myocardial infarction, atrial fibrillation, severe arrhythmias not allowing the Doppler analysis, pacemaker and any image by inadequate Doppler ultrasound
* Major person under legal protection (backup justice, trusteeship, guardianship), person deprived of liberty.

Primary outcomes:
measure: Invasive evaluation of left ventricular end diastolic pressure
timeFrame: D0
Secondary outcomes:
measure: Non-invasive evaluation of left ventricular end diastolic pressure
timeFrame: D0
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Erwan Donal, Md, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03493204: Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial
Official title: Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Encephalopathy
Ascites
Liver Diseases
Cirrhosis
Keywords: Hepatic Encephalopathy
Ascites
Liver Diseases
Cirrhosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 44
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 purpose of this study is to determine the feasibility of a home meal delivery program for patients with cirrhosis and ascites and to determine the effectiveness of a salt-restricted (2 gram sodium) meal delivery program in reducing the need for therapeutic paracenteses and/or all-cause re-admissions for these patients. Many patients with cirrhosis don't have enough nutrients in the body and are frail and these meals may help them maintain a good diet and lead to improved quality of life.


Eligibility criteria: Inclusion Criteria:

* Adult 18 years or older of age
* Clinical diagnosis of cirrhosis with ascites. Diagnosis of cirrhosis will be based upon:

  1. liver biopsy, OR
  2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
  3. 2 of the following 4 criteria: i. Ultrasound (US), computerized axial tomography (CT) or Magnetic Resonance Imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites) ii. Fibroscan liver stiffness score \>13 kPa iii. Laboratory testing: Aspartate Aminotransferase (AST)/platelet ratio index (APRI) \>2.0 iv. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
* 3) At least one of the following: Any cause hospitalization within 90 days OR outpatient therapeutic paracentesis within 30 days

Exclusion Criteria:

* Language barriers that cannot be surmounted with in-person interpreters
* Estimated life expectancy \< 3 months
* Pregnancy (self-reported)
* Unable or unwilling to provide consent
* History of liver transplant
* Planned discharge to nursing facility
* Anuria or serum creatinine \> 2.0 mg/dL
* Uncontrolled hepatic encephalopathy

Primary outcomes:
measure: Number of therapeutic paracenteses
timeFrame: From date of randomization until 12 weeks
Secondary outcomes:
measure: Change in Quality of life
timeFrame: baseline, week 12
Other outcomes:
measure: Number of hospital-bed days in 12 weeks
timeFrame: From date of randomization until 12 weeks
measure: Change in diuretic dose
timeFrame: baseline, week 12
measure: Change in frailty measures
timeFrame: baseline, week 12
measure: Change in frailty measures
timeFrame: baseline, week 12
measure: Quality of life
timeFrame: baseline, week 12
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Elliot Tapper
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02188004: The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases
Official title: The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases In Male and Female Aged Over 18 Years In China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Infection
Genital Warts
Keywords: HPV
genital warts
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: Liuzhou center of disease prevention and control
First posted: 2014-07-11
Enrollment: 4691
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 5000 healthy volunteers will be recruited from the residents of Liuzhou through advertisment.

Brief summary: primary purpose:Evaluate the prevalence and incidence of HPV infection and related diseases in subjects.

Secondary purpose:Analyze risk factors of HPV infection and related diseases.


Eligibility criteria: Inclusion Criteria:

* ages 18 to 55 years;
* residents of the study site;
* at least one sex partner;
* Be able to understand and comply with the request of the protocol.

Exclusion Criteria:

* pregnant;
* has received HPV vaccines.

Primary outcomes:
measure: prevalence and incidence of HPV infection
timeFrame: 1 year
Secondary outcomes:
measure: risk factors of HPV infection and related diseases
timeFrame: 1 year
Other outcomes:
Locations:
city: Liuzhou
country: China
facility: Liuzhou Center of disease prevention and control
state: Guangxi
Study officials:
affiliation: Xiamen University
name: Jun Zhang
role: STUDY_CHAIR
affiliation: Liuzhou center of disease prevention and control
name: Ming-Qiang Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wei F, Guo M, Huang S, Li M, Cui X, Su Y, Wu X, Ma X, Zheng Y, Huang Y, Wang L, Pan L, Wu T, Zhang J, Xia N. Sex Differences in the Incidence and Clearance of Anogenital Human Papillomavirus Infection in Liuzhou, China: An Observational Cohort Study. Clin Infect Dis. 2020 Jan 1;70(1):82-89. doi: 10.1093/cid/ciz168.
Clinical trial NCT01015404: A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)
Official title: A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodontitis
Keywords: Trafermin
Periodontitis
Lead sponsor: Kaken Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-11-18
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery.


Eligibility criteria: Inclusion Criteria:

* Vertical intrabony defect from radiographs at baseline
* Age of 20 years or older

Exclusion Criteria:

* Using an investigational drug within the past 24 months
* Coexisting malignant tumour or history of the same
* Coexisting diabetes (HbA1C 6.5% or more)
* Taking bisphosphonates
* Coexisting gingival overgrowth or history of the same

Primary outcomes:
measure: serum Trafermin level
timeFrame: within 4 weeks
Secondary outcomes:
measure: occurrence and level of adverse reaction
timeFrame: within 4 weeks
measure: serum anti-Trafermin antibody level
timeFrame: within 4 weeks
Other outcomes:
Locations:
city: Chiyoda-ku
country: Japan
facility: Kaken Investigational Site 5
city: Matsudo
country: Japan
facility: Kaken Investigational Site 2
city: Ota-ku
country: Japan
facility: Kaken Investigational Site 3
city: Sapporo
country: Japan
facility: Kaken Investigational Site 1
city: Shinjuku-ku
country: Japan
facility: Kaken Investigational Site 4
city: Suita
country: Japan
facility: Kaken Investigational Site 6
Study officials:
affiliation: Kaken Pharmaceutical Co., Ltd.
name: Chikara Ieda
role: STUDY_DIRECTOR
References:
citation: Kitamura M, Nakashima K, Kowashi Y, Fujii T, Shimauchi H, Sasano T, Furuuchi T, Fukuda M, Noguchi T, Shibutani T, Iwayama Y, Takashiba S, Kurihara H, Ninomiya M, Kido J, Nagata T, Hamachi T, Maeda K, Hara Y, Izumi Y, Hirofuji T, Imai E, Omae M, Watanuki M, Murakami S. Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial. PLoS One. 2008 Jul 2;3(7):e2611. doi: 10.1371/journal.pone.0002611.
Clinical trial NCT03218501: A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
Official title: A Phase II, Double-Blind, Randomized, Placebo-Controlled Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uremic Pruritus in Hemodialysis Patients
Keywords: Uremic Pruritus
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-07-14
Enrollment: 269
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety and dose response of SK-1405 for the treatment of subjects with uremic pruritus receiving hemodialysis, during 2 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Receiving hemodialysis three times a week for at least 12 weeks
* Worst itching VAS in a day is 30 mm or more at least 5 days during the first observation period
* Mean worst itching VAS is 50 mm or more in both the first and second observation periods

Exclusion Criteria:

* Complications that may affect the assessment of uremic pruritus
* Started or changed pruritus treatment within 13 days prior to starting observations
* Received ultraviolet treatment within 27 days prior to starting observations
* Uncontrollable hypertension, serious liver disease, serious heart disease, stroke, or malignant tumor
* Depression, schizophrenia, dementia, epilepsia, convulsive seizure, drug addiction, or alcoholism
* Pregnancy, or breastfeeding

Primary outcomes:
measure: Change from baseline in Worst-itching Visual Analog Scale (VAS)
timeFrame: 2 weeks
Secondary outcomes:
measure: Change from baseline in Worst-itching Visual Analog Scale (VAS)
timeFrame: 1 week, 3 weeks
measure: Change from baseline in Itch Severity Assessment
timeFrame: 1 week, 2 weeks, 3 weeks
measure: Change from baseline in Sleep Quality Assessment
timeFrame: 1 week, 2 weeks, 3 weeks
measure: Change from baseline in 5D Itch Scale
timeFrame: 2 weeks
measure: Number of Participants with Adverse Events
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Investigational site (there may be other sites in this country)
Study officials:
References:
Clinical trial NCT04330001: Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL
Official title: Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Presbyopia
Keywords: IOL
Cataract
Accommodation
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-04-01
Enrollment: 99
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this clinical study is to assess the repeatability of objective refraction using auto refraction on subjects bilaterally implanted (implanted in both eyes) with the Fluid Accommodating IOL (FAIOL).

Detailed description: Subjects will be expected to attend 10 office visits from screening to exit. The total expected duration of participation for each subject in this study is approximately 12 months. The second eye surgery will take place within 7-15 days from the date of the first implanted eye. The primary endpoint will be collected at Month 1, following the 2nd eye implant date.

Eligibility criteria: Inclusion Criteria:

* Willing and able to attend all scheduled study visits as required per protocol
* 22 years of age or older
* Bilateral cataracts
* Corneal astigmatism ≤ 1.25 D
* Clear intraocular media other than cataract
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply:

  1. are currently pregnant,
  2. have a positive urine pregnancy test result at V0,
  3. intend to become pregnant during the study period,
  4. are breast-feeding.
* Subjects taking medications that may affect accommodation, confound the outcome, or as per the Investigator's opinion may increase the risk to the subject
* Glaucoma
* Significant corneal or retinal abnormalities, per the Investigator's opinion, or other disease or pathology other than cataract expected to reduce postoperative vision
* Monocular patient, significant permanent visual function loss, or binocular vision anomalies as evaluated by specific testing
* Previous corneal procedure (such as LASIK, keratotomy, LRI) or plans to have additional corneal procedures during the study
* Systemic disease that could increase the operative risk or confound the outcome
* Other protocol-specified exclusion criteria may apply

Primary outcomes:
measure: Repeatability of objective refraction
timeFrame: Month 1 (post 2nd eye implant)
Secondary outcomes:
Other outcomes:
Locations:
city: San Salvador
country: El Salvador
facility: Alcon Investigator 8071
city: Panamá
country: Panama
facility: Alcon Investigator 8165
Study officials:
affiliation: Alcon Research
name: Clinical Operation Lead CDMA Surgical
role: STUDY_DIRECTOR
References:
Clinical trial NCT04883801: Clinical Outcomes of Newborns Born to Pregnant Women With and Without COVID-19
Official title: Comparison of Early Postnatal Clinical Outcomes of Newborns Born to Pregnant Women With COVID-19: A Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Vertical Transmission of Infectious Disease
Neonatal Infection
Pregnancy Related
Keywords: Childbirth
COVID-19
Neonatal outcomes
Newborn
Pregnant women
Vertical transmission
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 202
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns born to pregnant women with and without COVID-19 at Denizli State Hospital between March 11, 2020 - March 11, 2021.

Brief summary: A case-control trial was conducted to test the early postpartum period clinical outcomes of newborns born to pregnant women with and without COVID-19.


Eligibility criteria: Inclusion Criteria:

Pregnant women on labor or preterm labor. Pregnant women who underwent programmed or emergence cesarean

Exclusion Criteria:

Those who were transferred to another hospital without or within a short period of delivery

Primary outcomes:
measure: Vertical transmission
timeFrame: 48 hours after birth
measure: Neonatal birth outcomes
timeFrame: At birth
measure: Neonatal postnatal outcomes
timeFrame: Within 48 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Denizli State Hospital
Study officials:
References:
Clinical trial NCT05497401: A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS
Official title: A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: ARDS
Lead sponsor: BonusBio Group Ltd
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy of the allogeneic cell-therapy product MesenCure in addition to standard of care will be evaluated in comparison to placebo control in 300 moderate to severe Covid patients


Eligibility criteria: Inclusion Criteria:

1. Patients are able and agree to sign informed consent form before any study-specific procedure.
2. Males or females, age range 18-80.
3. Documented ARDS
4. RA-O2 Saturation of ≤93% and/or Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography
5. Stable hemodynamic condition (blood pressure of systolic \<180mm Hg and diastolic \<110mm Hg)

Exclusion Criteria:

General:

1. Pregnant or breast-feeding females.
2. History of drug abuse.
3. Heavy smokers (above 2 packages a day).
4. Subjects incapable of giving consent.

Background medical conditions:

1. Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.
2. History of advanced congestive heart failure or active acute myocardial infarction (AMI), renal failure (estimated GFR of \<30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C).
3. Known autoimmune diseases.
4. Received any investigational drug within 30 days prior to screening day (Visit 1) (Remdesivir is not considered investigational, and is not an exclusion criteria).
5. Immunocompromised condition from any reason, at screening.
6. Abnormal clinically significant laboratory test findings, as per the investigator's judgment.
7. Poorly controlled diabetic subjects (HbA1c \> 9%).
8. Known active lung malignancy.

Concomitant treatment:

1. Currently treated with Immunosuppressive agents other than corticosteroids used for treating COVID19.
2. Treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12 months.

Hypersensitivity:

1. Known history of hypersensitivity to Dextran-40.
2. Known history of hypersensitivity to Human Serum Albumin.

Primary outcomes:
measure: Mortality
timeFrame: 1 month
measure: CRP reduction
timeFrame: 14 days
measure: Invasive ventilation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03019601: Enhancing Uptake of Family Planning Services by HIV-Infected Women Attending the PMTCT Program
Official title: Enhancing Uptake of Family Planning Services by HIV Infected Women Attending the Postpartum Component of the PMTCT Program in Mulago National Referral Hospital, Kampala, Uganda Utilizing HIV-Infected Peers as Family Planning Champions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: HIV
PMTCT
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: MU-JHU CARE
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2017-01-12
Enrollment: 3300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A specific organized program utilizing peers in the PMTCT clinic who provide family planning information and support to HIV infected mothers was compared to providing standard family planning messages currently used in the clinic.

Detailed description: A planned group education structural intervention utilizing peers in the PMTCT clinic who provide family planning information and support to HIV infected mothers was compared to the standard of care which consisted of providing standard family planning messages to women attending the PMTCT Clinic. The study had two phases.

The Formative Phase consisted of six focus group discussions and six in depth interviews.

In the Implementation Phase, patient attendance and family planning uptake summaries for during implementation were monitored and summarized daily. Weekly average summaries were considered as time points.

Eligibility criteria: Inclusion Criteria:

* This being a program based intervention, all HIV positive mothers who utilize the PMTCT and post natal clinic during the study period will be enrolled.

Exclusion Criteria:

* none

Primary outcomes:
measure: proportion of mothers who took up Family Planning
timeFrame: weekly for one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MU-JHU CARE
name: Peter Mudiope, MBChB, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01632501: Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand
Official title: Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerotic Heart Disease
Coronary Heart Disease
Lead sponsor: Hospital Sao Lucas da PUCRS
Sponsor class: OTHER
First posted: 2012-07-03
Enrollment: 84
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 freedom of choice in medicine is based on the physician's ability to treat their patients with the best available therapy. The armamentarium for percutaneous intervention is frequently determined on the basis of subjective criteria and the experience of the interventional cardiologist. The evaluation of devices used in coronary intervention, especially angiography and its clinical outcomes, has rarely been investigated; the exceptions are studies on stents. Therefore, the freedom of choice for the interventional cardiologist has been challenged, especially because of cost restrictions. This way this study aims to assess the safety and efficacy of a device of a single brand in performing percutaneous transluminal coronary angioplasty (guide catheters, guidewires, balloons, and stents) in selected patients.


Eligibility criteria: Inclusion Criteria:

The study included both male and female patients for stent implantation referred for angioplasty of coronary arteries with more than 18 years.

Exclusion Criteria:

* chronic total occlusion angioplasty,
* saphenous graft angioplasty,
* bifurcation angioplasty (lateral branch greater than 1.5 mm)
* plans to perform angioplasty on more than one vessel during the same procedure
* and primary angioplasty in acute myocardial infarction

Primary outcomes:
measure: Occurrence of: need to change the materials during the procedure (angioplasty).
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: