louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01261715: Staples Versus Dermabond for Closure of the Skin After Cesarean Section
Official title: Staples Versus Dermabond for Closure of the Skin After Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cesarean Section Wound
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 50
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: Two of the more frequently used options for skin closure following a cesarean delivery include staples or sutures (stitches). Another method of closure is Dermabond- liquid skin adhesive. This method of closure is used less frequently than either staples or sutures.

Few studies have been done regarding whether Dermabond is preferable or affect the outcome of a cesarean section surgery. The aim of our study is to find weather Dermabond haas better result for the closure of cesarean section wounds.


Eligibility criteria: Inclusion Criteria:

Woman over 18 year Woman having elective caesarean section

Exclusion Criteria:

Age under 18 Woman having an emergency caesarean section

Primary outcomes:
measure: Cosmetic objective evaluation of the scar
timeFrame: 6 weeks postoperatively
Secondary outcomes:
measure: The difference in pain between the two type of closure
timeFrame: 1 and 4 days postoperatively
measure: The difference in patient satisfaction with the scar result
timeFrame: 6 weeks postoperatively
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir medical center
Study officials:
affiliation: MD
name: Dana Sadeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05052515: The Effects of Dihydromiricetin on MASLD
Official title: The Effects of Natural Extract With Dihydromiricetin on MASLD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Keywords: dihydromiricetin
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The global wave of obesity has affected dramatically the incidence of non-alcoholic fatty liver disease (NAFLD) making it the leading cause of liver disease in the western world. NAFLD is considered the hepatic manifestation of metabolic syndrome and is strongly associated with type II diabetes, sleep apnea and cardiovascular disease. Although cardiovascular disease is the leading cause of death in patients with NAFLD, a subset of patients who meet the histological criteria for steatohepatitis have the highest risk for liver-related morbidity and mortality.

Reviewing literature, it appears that several pathophysiologic mechanisms related to metabolism, inflammation and fibrosis are deregulated in NAFLD, whereas dihydromiricetin natural extracts have been suggested to exhibit antioxidant activity. In contrast to Vitamin E, which has been studied as an agent for non-diabetic patients with NAFLD, epidemiological and/or clinical data for the use of dihydromiricetin natural extracts or their combination in NAFLD are limited.

Detailed description: The study will be randomized, placebo-controlled and double-blinded in order to avoid systemic errors, such as selection bias and the placebo effect. Patients will be randomly assigned to one of two groups: A) capsules with dihydromiricetin, vitamins C/E and choline (two capsules per day) and B) placebo (identical capsules). The duration of the intervention will be 12 months.

Eligibility criteria: Inclusion Criteria:

* Alanine aminotransferase (ALT) higher than the upper limit of normal with or without elevated γ-glutamyl transpeptidase (γGT)
* Hepatic steatosis-indicating findings on ultrasound and / or liver biopsy
* BMI 20-45 Kg/m2

Exclusion Criteria:

* Alcohol consumption \> 210 or \> 140 grams per week for men or women, respectively
* Use of a potentially hepatotoxic drug
* Detection of hepatitis B virus (HBsAg) surface antigen or Hepatitis C virus antibodies (anti-HCV) or HIV antibodies
* The coexistence of α systemic disease with potentially hepatic involvement

Primary outcomes:
measure: ALT change
timeFrame: 12 months.
Secondary outcomes:
measure: ALT and GGT changes
timeFrame: 6 and 12 months
measure: Liver stiffness change
timeFrame: 12 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko"
state: Attica
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Georgios Papatheodoridis, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04874415: Behavioral Economics for Activity Motivation in Adolescents (BEAM)
Official title: Behavioral Economics for Activity Motivation in Adolescents and Young Adults With Prediabetes and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
PreDiabetes
Insulin Resistance
Polycystic Ovary Syndrome
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-05-05
Enrollment: 75
Sex: ALL
Minimum age (years): 13
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: There is an urgent need to engineer targeted physical activity interventions that are effective and scalable for obese adolescents and young adults (AYA) with type 2 diabetes (T2D), who often have very low levels of physical activity. The BEAM Trial is a proposed mobile health (mHealth) intervention that uses behavioral economic-informed financial incentives and text messaging to promote physical activity in AYA with T2D and prediabetes.


Eligibility criteria: Inclusion Criteria:

* 1) Males or females age 13 to 22 years.
* 2) Overweight or obese (BMI ≥85th percentile for age/sex, or ≥25 kg/m2 for participants ≥18 years)
* 3) Diagnosis with prediabetes or type 2 diabetes
* 4) Consent (subjects 18 and older), Parental/guardian permission (subjects 13-17), assent (subjects 13-17)
* 5) Willingness to wear Fitbit during waking hours daily for duration of run-in and intervention.
* 6) Possession of a smartphone.

Exclusion Criteria:

* 1) Potential subject unable to speak or read in English
* 2) Severe cognitive impairment
* 3) Permanent or temporary physical disability that impairs ambulation or precludes engagement in MVPA
* 4) Current pregnancy
* 5) Previously-diagnosed or current restrictive or purging eating disorder
* 6) Moderate to vigorous physical activity (MVPA) \>30 minutes per day or Fitbit wear \< 4 days during second week of 2-week run-in period

Primary outcomes:
measure: Moderate to Vigorous Physical Activity (MVPA)
timeFrame: 12 weeks
Secondary outcomes:
measure: Daily Step Count
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01892215: Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad,
Official title: Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad. A Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blunt Expansion of the Uterine Incision
Keywords: Uterine incision.
Blunt transversal expansion.
Blunt cephalad-caudad expansion.
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 839
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obstetrical blood loss is an important reason of maternal morbidity and mortality. Because of the increase in the rate of cesarean section, any procedure that could help reduce blood loss during cesarean section should be investigated. The purpose of this study was to compare 2 methods of blunt expansion of the uterine incision at the time of cesarean delivery: transversal vs. cephalad-caudad.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies
* Gestational age: 34 weeks or more
* Delivery by cesarean section
* Presurgical hemoglobin \> 10.5 g/dL

Exclusion Criteria:

* Two or more previous cesarean sections
* History of uterine rupture in a previous pregnancy
* History of myomectomy
* History of abdominal trauma with an uterine lesion
* Blood dyscrasia
* Multiple pregnancy
* Placenta previa
* Abruptio placenta
* Stillbirth
* Sharp uterine expansion

Primary outcomes:
measure: Blood loss (hemoglobin level)
timeFrame: 72 hours
Secondary outcomes:
measure: Surgical complications
timeFrame: 72 hours
measure: Unintented extension of uterine incision
timeFrame: 72 hours
measure: Hematoma formation
timeFrame: 72 hours
measure: Need for transfusion
timeFrame: 72 hours
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
affiliation: Saint Thomas Maternity Hospital
name: Osvaldo Reyes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Thomas Maternity Hospital
name: Alberto Morales, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01408615: A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
Official title: Post Marketing Surveillance for General Drug Use to Assess the Safety and Efficacy Profile of ELONVA in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-08-03
Enrollment: 472
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women participating in an ART program consisting of COS in combination with a GnRH antagonist in a general clinical setting.

Brief summary: This observational study will examine the safety and efficacy profile of Elonva (corifollitropin alfa) when administered in Korean women undergoing controlled ovarian stimulation (COS) in combination with a gonadotropin-releasing hormone (GnRH) antagonist for the development of multiple follicles in an assisted reproductive technology (ART) program.


Eligibility criteria: Inclusion Criteria:

- Women with an indication for COS prior to in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) who meet the criteria as mentioned in the current Korean ELONVA local label

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Tumors of the ovary, breast, uterus, pituitary or hypothalamus
* Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
* Primary ovarian failure
* Ovarian cysts or enlarged ovaries
* A history of OHSS
* A previous COS cycle that resulted in more than 30 follicles ≥ 11 mm measured by ultrasound examination
* Basal antral follicle count \> 20
* Fibroid tumors of the uterus incompatible with pregnancy
* Malformations of the reproductive organs incompatible with pregnancy
* Pregnancy
* Polycystic ovarian syndrome

Primary outcomes:
measure: Number of Oocytes Retrieved
timeFrame: At time of oocyte retrieval (up 3 days from human chorionic gonadotropin [hCG] injection)
measure: Number of Participants who Experience Ovarian Hyperstimulation Syndrome (OHSS)
timeFrame: During treatment and up to 30 days after cessation of treatment
measure: Number of Participants who report an serious adverse event (SAE)
timeFrame: During treatment and up to 30 days after cessation of treatment
measure: Number of Participants who report an adverse event (AE)
timeFrame: During treatment and up to 30 days after cessation of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05070715: Comparison of Microplastic Levels in Placenta and Cord Blood Samples of Pregnant Women With Fetal Growth Retardation and Healthy Pregnant Women
Official title: Comparison of Microplastic Levels in Placenta and Cord Blood Samples of Pregnant Women With Fetal Growth Retardation and Healthy Pregnant Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microplastic Levels in Placenta and Cord Blood
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Multiple pregnancies
* Cardiovascular disease
* Chronic hypertension
* Autoimmune disease
* Intrahepatic cholestasis of pregnancy
* Preeclampsia-eclampsia
* Sepsis
* Placenta accreta spectrum
* Abnormalities of placenta
* The chromosomal or congenital structural anomaly of the fetus
* Smoking
* BMI \>30 kg/m2

Brief summary: In this study, microplastic levels in the placenta and cord blood of pregnant women with fetal growth retardation and healthy pregnant women will be compared in placenta and cord blood samples after delivery.

Detailed description: The study will be conducted with a total of 40 pregnant women, 20 of whom are in the control groups and those with FGR diagnoses. Cases in both groups will be matched in terms of demographic information. Demographic information (including socioeconomic status, educational level, region of residence), ultrasound and Doppler examination results, newborn weight at birth, APGAR score, gender, mode of delivery, whether there is a need for neonatal intensive care or not will be recorded.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-40 years
* Gestational age between 320/7 - 396/7 weeks
* Singleton pregnancy
* For the FGR group: estimated fetal weight \<10th percentile
* For the control group: being healthy pregnant
* Intact amniotic membrane

Exclusion Criteria:

-

Primary outcomes:
measure: Analyzing of microplastic levels in the placenta and cord blood of pregnant women
timeFrame: 1 year
Secondary outcomes:
measure: Investigation of the effect of microplastic level in placenta and cord blood on FGR
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
citation: Ragusa A, Svelato A, Santacroce C, Catalano P, Notarstefano V, Carnevali O, Papa F, Rongioletti MCA, Baiocco F, Draghi S, D'Amore E, Rinaldo D, Matta M, Giorgini E. Plasticenta: First evidence of microplastics in human placenta. Environ Int. 2021 Jan;146:106274. doi: 10.1016/j.envint.2020.106274. Epub 2020 Dec 2.
citation: Braun T, Ehrlich L, Henrich W, Koeppel S, Lomako I, Schwabl P, Liebmann B. Detection of Microplastic in Human Placenta and Meconium in a Clinical Setting. Pharmaceutics. 2021 Jun 22;13(7):921. doi: 10.3390/pharmaceutics13070921.
Clinical trial NCT06723015: Tau PET Outcomes With Anti-amyloid Immunotherapies
Official title: Study of Tau PET Outcomes in Patients Receiving Anti-amyloid Immunotherapies
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Cognitive Impairment, Mild
Dementia, Mild
Alzheimer Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 135
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is an imaging study of patients with mild Alzheimer's disease receiving amyloid-targeting therapy and under the care of neurologists at Mayo Clinic in Rochester, MN.


Eligibility criteria: Inclusion Criteria

* Age 50-90 years
* Male or female
* Mild cognitive impairment due to AD or mild AD
* Amyloid positive via CSF or PET
* Meets other eligibility criteria for anti-amyloid immunotherapy
* Subject or delegate provides informed consent

Exclusion Criteria

* Subjects unable to lie down without moving for 10 minutes.
* Women who are pregnant or cannot stop breast feeding for 24 hours.
* Claustrophobic patients unable to tolerate the scans (no sedation can be offered).

Primary outcomes:
measure: Change in tau PET Standardized Uptake Value (SUVR)
timeFrame: Baseline, 18 months
Secondary outcomes:
measure: Number of subjects to develop amyloid-related imaging abnormalities (ARIA)
timeFrame: 18 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Petrice Cogswell, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02485015: The Study of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer
Official title: The Randomized, Controlled, Multicenter Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Stomach Neoplasms
Keywords: CIK
gastric cancer
Apatinib
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
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 safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib as the third line therapy for patients with advanced gastric cancer.

Detailed description: 400 patients with stage Ⅳ Gastric Cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive Apatinib and CIK treatment ) or group B（just receive Apatinib),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .

Eligibility criteria: Inclusion Criteria:

* Patients who can accept curative operations 18-70 years old
* Histologically confirmed with gastric cancer at stage Ⅳ
* Patients who can accept oral drugs;
* Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.

Exclusion Criteria:

* Hemoglobin\<8.0 g/dL,White blood cell \<3 X 10\^9/L;Platelet count \<75 X 10\^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Pregnant or lactating patients
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
* Patients who are suffering from serious autoimmune disease
* Patients who had used long time or are using immunosuppressant
* Patients who had active infection
* Patients who are suffering from serious organ dysfunction
* Patients who are suffering from other cancer
* Other situations that the researchers considered unsuitable for this study.

Primary outcomes:
measure: Overall Survival(OS)
timeFrame: 3 months
Secondary outcomes:
measure: Disease-free survival
timeFrame: 3 months
Other outcomes:
measure: Adverse events
timeFrame: 1 months
Locations:
Study officials:
References:
Clinical trial NCT03285815: Prostate Cancer - Localized Adenocarcinoma Proton Therapy
Official title: A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With a Localized Prostate Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Adenocarcinoma
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2017-09-18
Enrollment: 156
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized Prostate Adenocarcinoma

Detailed description: For Proton therapy with prostate adenocarcinoma patients.

Arm 1: Proton therapy 3CGE x 20days = Total 60 CGE for 4 weeks.

Arm 2: Proton therapy 4.7CGE x 10days = Total 47 CGE for 2 weeks.

Eligibility criteria: Inclusion Criteria:

* Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0
* ECOG performance status:0-1
* Signed study specific informed consent prior to study entry.

Exclusion Criteria:

* Postoperative residual or recurrent tumor
* Evidence of distant metastasis previous irradiation for the tumor in the same location
* Adjuvant anti-androgenic hormonal therapy High risk group (NCCN guide line)

Primary outcomes:
measure: BCFFS
timeFrame: up to 5 years from a initial follow-up
Secondary outcomes:
measure: Acute/late toxicity (CTCAE v4.0)
timeFrame: up to 5 years from a initial follow-up
measure: Disease specific survival
timeFrame: up to 5 years from a initial follow-up
measure: EPIC (Extended Prostate Cancer Index Composite)
timeFrame: up to 5 years from a initial follow-up
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: Kwanho Cho
state: Gyenggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: Kwanho Cho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02717715: SunRISe Study - Stroke Rehabilitation In Suriname
Official title: The Effect of a Tele-supervised Home Based Rehabilitation Program on Physical Fitness, Quality of Gait, Upper Limb Disability and Quality of Life in People After Chronic Stroke in a Urban Setting in Suriname. Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Anton De Kom University
name: VU University of Amsterdam
First posted: 2016-03-24
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine the effect of a supervised home-based physical fitness program on the aerobic capacity, quality of gait and health related quality of life in people with chronic ischemic stroke. Secondly, feasibility of the program for implementing a long term lifestyle change will be investigated.


Eligibility criteria: Inclusion Criteria:

* ability to give informed consent
* ability to understand measurement procedures defined as MMSE \>24
* last stroke \>6 months ago
* mild to moderate stroke deficit defined by Fugl Meyer test score of 27 to 90 for upper and lower extremities
* FAC ≥3
* medical clearance to participate in a moderate exercise program
* living at home and having a minimum of 5 stairs at home

Exclusion Criteria:

* serious cardiac condition
* other serious end organ damage
* other neurological deficits leading to disability
* uncontrolled blood pressure (systolic pressure \>140, diastolic pressure \>90)

Primary outcomes:
measure: Change in peak oxygen uptake
timeFrame: 4 weeks, 8 weeks and 5 months after start of rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
city: Paramaribo
country: Suriname
facility: Anton De Kom University
Study officials:
References: