louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04676269: Amnion Bilayer and Stem Cell Combination Therapy on Thin Endometrium Infertile Patients
Official title: Amnion Bilayer and Stem Cell Combination Therapy on Thin Endometrium Infertile Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cell- and Tissue-Based Therapy
Keywords: Endometrial stem cells
Amnion epithelial stem cells
Amnion bilayer
Thin endometrium
Secondary amenorrhoe
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 40
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Severe infections or trauma to the endometrial lining causes permanent scars that disrupt the menstrual cycle and lead to conceive failure. Transplantation of biological graft seeded with stem cells is purposed to regenerate and recover the capability of the endometrial lining back into its cycles. Initially, the techniques to isolate and culture the endometrial cells and amnion epithelial stem cells were developed, then the endometrial cells form patients with thin endometrium. Tissue were obtained from hysteroscopic biopsy, weight between 100 µl, while up to 20 µl from the thin endometrium. Tissue were digested using collagenase-1 and cultured using DMEM-F12 added wit epidermal growth factor. Endometrial cells will be characterized to SSUD2, ICAM and BRCP1. Amnion epithelial stem cells (hAESC) will be isolated using collagenase-1 and hyaluronidase. Characterization towards TRA-1-60, SSEA-4, Oct 3/4, and Nanog. In the future, the cells will be co-culture on amnion bilayer, and stained using IHC against α-cadherin, estrogen receptor α, progesterone receptor. Endometrial receptivity (HOXA10, LIF (early secretory) adhesion, VEGF, osteopontin (SPP1) to indicate the pinopodes will be identified using qPCR.The SPP1, target of MIR424 expressed during the receptive phase.


Eligibility criteria: Inclusion Criteria:

* Patients with thin endometrium without scar
* Patients with acute thin endometrium post-therapy (medicamentosa)
* Patients who are willing to participate in the study

Exclusion Criteria:

* Patients with thin endometrium due to TB
* Patients with cancer in the reproductive system

Primary outcomes:
measure: Change in endometrium thickness
timeFrame: 7 and 14 days after amnion bilayer seeded with endometrial cells co-cultured with hAESC is transplanted into patient' womb
measure: Change in amenorrhea severity
timeFrame: 7 and 14 days after amnion bilayer seeded with endometrial cells co-cultured with hAESC is transplanted into patient' womb
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUPN Cipto Mangunkusumo
state: DKI Jakarta
Study officials:
affiliation: Faculty of Medicine, Indonesia University
name: Achmad Kemal Harzif, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05861869: Clinical Trial of PLA2R-IgG4 Detection Kit (Time-resolved Fluorescence Immunoassay)
Official title: Clinical Trial of PLA2R-IgG4 Detection Kit (Time-resolved Fluorescence Immunoassay)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Membranous Nephropathy - PLA2R Induced
Kidney Diseases-except Membranous Nephropathy
Lead sponsor: Zhejiang Biostar Biotechnology Co.
Sponsor class: INDUSTRY
Collaborators: name: First Affiliated Hospital of Zhejiang University
name: Wuxi People's Hospital
name: Guangdong Provincial People's Hospital
First posted: 2023-05-17
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nephrology department visit /inpatient case

Brief summary: The goal of this observational clinical trial is to compare assessment reagents with clinical diagnostic criteria in patients with membranous nephropathy. The main questions it aims to answer are:

* Evaluating the sensitivity and specificity of the test reagent in the diagnosis of membranous nephropathy.
* Evaluating whether the clinical diagnostic performance of the test reagent meets the requirements for auxiliary diagnosis of membranous nephropathy.

Participants will provide approximately 4ml of blood. Researchers will compare the levels of anti-PLA2RIgG4 in patients with membranous nephropathy and patients with other renal diseases,to see if there is a significant difference.


Eligibility criteria: Inclusion Criteria:

* PLA2R-induced membranous nephropathy group

  1. Pathological examination showed that patients with membranous nephropathy were positive for PLA2R by immunohistochemistry, and the symptoms were not completely relieved; (24 h urine protein quantification\<0.3g or urine protein /creatinine (uPCR)\<300mg /g is regarded as complete remission)
  2. In patients with nephrotic syndrome (serum albumin ≤ 30.0g /L, clinical manifestations show moderate to large amount of proteinuria (urine protein\>3.5g /L or urine protein /creatinine ratio ≥ 3500mg /g), and their serum anti PLA2R antibody detection shows positive.
* Secondary membranous nephropathy group Patients in nephrology department who have ruled out primary membranous nephropathy.

the patient has the remaining serum samples of normal test, and the serum volume of the sample is not less than 1ml.

Exclusion Criteria:

1. The amount of centrifuged serum sample after blood collection is less than 1ml or the amount of residual serum in normal test is less than 1ml;
2. Non-serum samples, plasma samples;
3. Patients with mental or cognitive disorders;
4. No samples with definite clinical diagnosis;
5. Samples with incomplete information.

Primary outcomes:
measure: Content of anti-PLA2r IgG4
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: ZhejiangBiostar
Study officials:
References:
Clinical trial NCT02949869: Variability of Infant LP Insertion Site Based On Procedural Experience
Official title: Variability of Infant LP Insertion Site Based On Procedural Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Lumbar Puncture
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 110
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The reported rate of unsuccessful traditional LP in children (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) is as high as 50%. Many factors affect LP success including provider experience. CSF is obtained by puncturing the subarachnoid space (traditionally at the L3-L4 or L4-L5 interspinous process space), and many have hypothesized that the width of this space may predict success. Anecdotally, trainees and those with less experience, tend to perform the LP too low (caudally), where the subarachnoid space tapers, or too laterally (off the midline) resulting in higher failure rates. The investigators seek to determine if planned LP insertion sites vary between training and attendings, and if so, could the decreased success be explained by smaller subarachnoid spaces.


Eligibility criteria: Inclusion Criteria:

1. Less than or equal to 12 months of age
2. Availability of a study sonographer to perform bedside ultrasound

Exclusion Criteria:

1. Prior history of LP in preceding 72 hours
2. Known spinal cord abnormality (i.e., tethered cord, spina bifida)
3. Clinically unstable patients (acuity level 1)

Primary outcomes:
measure: Proportion of Trainee & Attending LP Insertion Sites that are the same
timeFrame: 18 months
Secondary outcomes:
measure: Subarachnoid Space Width
timeFrame: 18 months
measure: Subarachnoid Space Area
timeFrame: 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Rebecca Vieira, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schreiner RL, Kleiman MB. Incidence and effect of traumatic lumbar puncture in the neonate. Dev Med Child Neurol. 1979 Aug;21(4):483-7. doi: 10.1111/j.1469-8749.1979.tb01652.x.
citation: Pinheiro JM, Furdon S, Ochoa LF. Role of local anesthesia during lumbar puncture in neonates. Pediatrics. 1993 Feb;91(2):379-82.
Clinical trial NCT05649969: STRONG Program for Cancer Patients
Official title: STRONG-PD: Support Through Remote Observation And Nutrition Guidance (STRONG) Program For Cancer Patients With Peritoneal Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gastrointestinal Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastrointestinal cancer who are receiving chemotherapy and surgical treatment.


Eligibility criteria: Inclusion Criteria:

* Gastrointestinal Cancer diagnosis (e.g., colon cancer, appendiceal cancer)
* Peritoneal disease diagnosis
* Received Cytoreductive Surgery and Heated Intra-Peritoneal Chemotherapy (CRS-HIPEC) for curative intent at Moffitt
* Transitioned to an oral diet post-surgery
* Able to speak and read English
* Able to provide informed consent

Exclusion Criteria:

* Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)
* Undergoing concurrent treatment for a secondary primary cancer
* Receipt of parenteral or enteral nutrition after surgery

Primary outcomes:
measure: Feasibility of the STRONG Program
timeFrame: at 12 weeks
measure: Acceptability of the STRONG Program
timeFrame: at 16 weeks
measure: Adherence to the STRONG Program
timeFrame: at 16 weeks
measure: Efficacy of STRONG Program on Treatment Outcomes
timeFrame: at 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Amir Alishahi Tabriz, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Ben Powers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04650269: Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program
Official title: Implementation of Onsite, Rapid Antiretroviral Therapy (ART) Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Harm Reduction
HIV Infections
Drug Use
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2020-12-02
Enrollment: 27
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 purpose of this study is to see if providing HIV medicine right away at the IDEA Syringe Services Program will help the participant start and remain in HIV care, including having no detectable HIV in the participant's blood.


Eligibility criteria: Inclusion Criteria:

1. Adult (age\>18 years);
2. positive rapid HIV test;
3. ability to provide informed consent;
4. HIV RNA \> 200 copies/ml;
5. creatinine clearance \> 30 mg/dl as measured by serum creatinine;
6. no allergy to bictegravir/emtricitabine/tenofovir alafenamide (BFTAF) as indicated by patient history and self-reported allergies.

Exclusion Criteria:

1) Any other comorbidities at the discretion of the investigator

Primary outcomes:
measure: Percentage of Participants With HIV Viral Load Suppression
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Participants With HIV Viral Load Suppression
timeFrame: 1 month
measure: Percentage of Participants With HIV Viral Load Suppression
timeFrame: 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hansel Tookes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06056869: Effect of Hyoscine- Bromide on Duration of the First Stage of Labor
Official title: Effect of Hyoscine- Bromide on Duration of the First Stage of Labor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spasmolytic drugs are frequently used in delivery rooms to overcome cervical spasms and thus reduce the duration of labor. The aim of this randomized double blind placebo controlled trial is to study the efficacy of hyoscine butylbromide (HBB) for shortening of the first stage of labor in primigravid women.


Eligibility criteria: Inclusion Criteria:

1. Primigravid women.
2. Singleton pregnancy.
3. Presenting by the vertex.
4. Gestational age between 37 and 42 weeks
5. In active phase of labor with a cervical dilatation between 4-5 cm, with either intact membranes or spontaneous rupture of membranes for less than 12 h

Exclusion Criteria:

1. Previous uterine scarring.
2. Malpresentation.
3. Antepartum hemorrhage.
4. Labor induction
5. Contraindication to vaginal delivery.
6. Contraindication to hyoscine.

Primary outcomes:
measure: duration of first stage of labor
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University maternity hospital
state: Cairo/القاهرة
Study officials:
affiliation: Associate professor
name: Maii Nawara
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03936569: A Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice
Official title: A 3-Month Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingivitis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2019-05-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 16 gradable teeth;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion Criteria:

* Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
* Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Removable oral appliances;
* Fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Any diseases or condition that might interfere with the safe participation in the study; and
* Inability to undergo study procedures.

Primary outcomes:
measure: Löe-Silness Gingivitis Evaluation
timeFrame: Baseline
measure: Löe-Silness Gingivitis Evaluation
timeFrame: 1 Month
measure: Löe-Silness Gingivitis Evaluation
timeFrame: 3 Months
Secondary outcomes:
measure: Turesky Modified Quigley-Hein Index
timeFrame: Baseline
measure: Turesky Modified Quigley-Hein Index
timeFrame: 1 Month
measure: Turesky Modified Quigley-Hein Index
timeFrame: 3 Months
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Silverstone Research Group
state: Nevada
Study officials:
References:
Clinical trial NCT00949169: Carotid Intima-media Thickness (IMT) and Large-vessel Atherosclerosis by Multidetector Computed Tomography (MDCT)
Official title: Association of Carotid IMT and Large-vessel Atherosclerosis by MDCT in Korean Type 2 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Atherosclerosis
Carotid IMT
Multidetector CT
Type 2 diabetes
Lead sponsor: Eulji University Hospital
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 71
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 2 diabetic patients who had multiple cardiovascular risk factors

Brief summary: The aim of this study was to investigate whether carotid IMT can predict the presence of more advanced atherosclerosis such as carotid stenosis, coronary or intracranial artery disease by MDCT and whether MDCT could be useful next step for more aggressive treatment modality in Korean type 2 diabetic patients.

Detailed description: We evaluated mean/maximal carotid IMT in seventy-one type 2 diabetic subjects, and defined increased carotid IMT as maximal IMT ≥ 1.0 mm. Multidetector CT (MDCT) and pulse wave velocity (PWV) were taken to evaluate carotid artery stenosis (CS), coronary artery disease (CAD), intracranial arterial lesion (ICA), and peripheral artery disease (PAD). We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT. We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients who had multiple cardiovascular risk factors were recruited.
* Patients who had atypical chest pain, EKG abnormality (ischemic ST-T changes or abnormal Q-wave), or history of previous cardiovascular disease were also included.

Exclusion Criteria:

* Acute coronary SD, serum Cr\>1.4 mg/dL, history of allergy to iodinated contrast dye were excluded.

Primary outcomes:
measure: We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT.
timeFrame: 17 months
Secondary outcomes:
measure: We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods.
timeFrame: 17 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eulji University Hospital
Study officials:
affiliation: Department of Internal Medicine, Eulji University Hospital
name: Kyung Wan Min, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00833469: Escitalopram (Lexapro) for the Treatment of Postpartum Depression
Official title: Escitalopram for the Treatment of Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postpartum Depression
Keywords: women
postpartum depression
anxiety
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2009-02-02
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether women with postpartum major depressive disorder (MDD) will experience a significant decrease in depressive symptoms from baseline over an eight-week treatment intervention with escitalopram (Lexapro). Also, to determine whether women with postpartum MDD will experience a significant decrease in anxiety symptoms.


Eligibility criteria: Inclusion Criteria:

* Women ages 18 to 45 years old
* Subjects must meet criteria for a major depressive episode with symptoms developing within three month of live childbirth
* Subjects must present within six months of childbirth
* MADRS score \>15
* BAI score \>10
* Subjects will be able to be treated on an outpatient basis
* Subjects will be able to provide written informed consent

Exclusion Criteria:

* Subjects who have taken any psychotropic medication, including antidepressants and anti-anxiety medication, within the past two weeks (with the exception of non-benzodiazepine medications used for sleep, including trazodone, zolpidem, eszopiclone, etc)
* Suicidal ideation with active plan or intent, as determined by the investigator
* Presence of psychotic symptoms or homicidal ideation
* History of mania or hypomania
* Pregnant or breastfeeding
* Presence of chronic depression or dysthymia, or chronic or treatment resistant anxiety disorders, as determined by investigator
* Active alcohol/substance abuse currently or within the past year
* Abnormal TSH, severe anemia, or uncontrolled hypertension

Primary outcomes:
measure: Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 8 weeks
measure: Change in Beck Anxiety Inventory (BAI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Marlene P Freeman, MD
role: PRINCIPAL_INVESTIGATOR
References: