louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04600076: MOMSonLINE2 ; A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers
Official title: MOMSonLINE2:A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stillbirth
Grief
Infant Death
Keywords: internet support site
BabyCenter.com.
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-10-23
Enrollment: 22
Sex: FEMALE
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: This is a 6-week pilot study to see how research participants feel about an internet support site after a stillbirth or infant death. Losing a baby through stillbirth or early infant death is typically devastating for families. However, investigators do not know if internet on-line support for parents helps manage grief more easily.

In addition to using the BabyCenter.com website, participants will be asked to complete online surveys at the beginning and the end of the study, as well partake in an interview.

Data from this pilot study will help develop a much larger randomized control study of on-line support outcomes after perinatal loss.


Eligibility criteria: Inclusion Criteria:

* Michigan residence and infant delivery
* Non-Caucasian race and/or Hispanic ethnicity
* Read/speak English
* Gave birth to a stillborn baby or had an infant death in the first 28 days of life
* Did not give the baby up for adoption pre-loss
* Internet access

Exclusion Criteria:

* Don't Read/speak English

Primary outcomes:
measure: Percentage of Participants Approached for Enrollment Who Signed up for the Study
timeFrame: 6 months
measure: Feasibility: Retention
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Depression as Measured by The Personal Health Questionnaire Depression (PHQ-8)
timeFrame: Pre intervention (day 0), Post intervention (6 weeks)
measure: Change in Post-traumatic Stress Disorder (PTSD)
timeFrame: Pre intervention (day 0), Post intervention (6 weeks)
measure: Change in Anxiety Based on the Generalized Anxiety Disorder Screen (GAD-7)
timeFrame: Pre intervention (day 0), Post intervention (6 weeks)
measure: Change in Grief Based on the Perinatal Grief Scale
timeFrame: Pre intervention (day 0), Post intervention (6 weeks)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Katherine Gold, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gold KJ, Boggs ME, Plegue MA, Andalibi N. Online Support Groups for Perinatal Loss: A Pilot Feasibility Study for Women of Color. Cyberpsychol Behav Soc Netw. 2022 Aug;25(8):534-539. doi: 10.1089/cyber.2021.0304. Epub 2022 Jul 20.
Clinical trial NCT04341376: Prevention of Childhood Maltreatment in Families With Young Children
Official title: Embedding Mental Health Consultation Within Prenatal Home Visiting to Prevent Child Maltreatment and Violence Exposure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Maltreatment
Child Exposure to Intimate Partner Violence
Lead sponsor: Bradley Hospital
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will examine the efficacy of Enhanced First Connections, which is a short-term perinatal home visiting program that includes infant and early childhood mental health consultation. Mothers with a history of adversity or trauma will be the focus of this research. Hypothesized outcomes of Enhanced First Connections include the prevention of child maltreatment (child abuse and neglect), prevention of child exposure to adult intimate partner violence, increases in family engagement in longer-term evidence based home visiting programs, increases in family engagement in specialized support services to address maternal adversity and trauma, reductions in maternal risk factors, and the promotion of positive parenting and the parent-child relationship.


Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Recruited in the second or third trimester of pregnancy
* At least one self-reported experience of adversity or trauma
* English or Spanish speaking

Exclusion Criteria:

- Does not meet all inclusion criteria above

Primary outcomes:
measure: Child Maltreatment Status
timeFrame: 6-months postpartum
measure: Child Exposure to Intimate Partner Violence
timeFrame: 6-months postpartum
measure: Maternal Report of Intimate Partner Violence
timeFrame: 6-months postpartum
Secondary outcomes:
measure: Family engagement in evidence based home visiting programs
timeFrame: 6-months postpartum
measure: Contextual stress exposure
timeFrame: 6-months postpartum
measure: Maternal depressive symptoms
timeFrame: 6-months postpartum
measure: Maternal anxiety symptoms
timeFrame: 6-months postpartum
measure: Maternal PTSD symptoms
timeFrame: 6-months postpartum
measure: Maternal alcohol use
timeFrame: 6-months postpartum
measure: Maternal substance use
timeFrame: 6-months postpartum
measure: Maternal parenting stress
timeFrame: 6-months postpartum
measure: Maternal sensitivity
timeFrame: 6-months postpartum
measure: Maternal hostility
timeFrame: 6-months postpartum
measure: Maternal non-responsiveness
timeFrame: 6-months postpartum
measure: Home environment
timeFrame: 6-months postpartum
measure: Mother-infant relationship
timeFrame: 6-months postpartum
Other outcomes:
Locations:
city: East Providence
country: United States
facility: E.P. Bradley Hospital
state: Rhode Island
Study officials:
affiliation: E.P. Bradley Hospital
name: Stephanie H Parade, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01885676: Plasma Rich in Growth Factors (PRGF-Endoret)in the Treatment of Androgenetic Alopecia
Official title: A Pilot Randomized, Double-blind, Placebo-controlled Clinical Trial to Obtain Preliminary Data on Efficacy and Safety in the Application of PRGF-Endoret by Mesotherapy, in the Treatment of Male and Female Androgenetic Alopecia of Over 6 Months Duration.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Androgenetic Alopecia
Lead sponsor: Biotechnology Institute IMASD
Sponsor class: INDUSTRY
First posted: 2013-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Androgenetic alopecia (AGA) or common baldness is the most common cause of hair loss in both men and women and is caused by the action of androgens in genetically predisposed individuals.
* This clinical trial was designed to evaluate the efficacy and safety of using a preparation of autologous plasma rich in growth factors (PRGF-Endoret) in the treatment of androgenetic alopecia.


Eligibility criteria: Inclusion Criteria:

* Androgenetic alopecia according to the following scales:
* Men: Hamilton/Norwood Scale: grades II-VI
* Women: Ludwig Scale grades I-II.
* Possibility of follow-up during the study

Exclusion Criteria:

* No androgenetic alopecia
* Telogen and anagen effluvium
* Active inflammation or infection in the intervention area
* Presence of active systemic infections.
* Background of cancerous or precancerous lesions.
* Background of connective or rheumatic diseases.
* Suffering from any serious blood disorders.
* To have undergone treatments for alopecia in the previous 6 months.
* Previous hair implants
* Intake of drugs that affect hair loss.
* Be undergoing immunosuppressive therapy and/or anticoagulants.
* Known intolerance to mesotherapy.
* Taking contraceptives containing cyproterone acetate.
* Pregnancy
* In general, any limitations that would prevent the proper application of both treatments and the right monitoring of the efficacy variables.

Primary outcomes:
measure: Change from baseline in Hair density at three months (number of hairs per cm2)
timeFrame: 3 months post-treatment
Secondary outcomes:
measure: Hair Width (micrometers)
timeFrame: Basal, 1, 2, and 3 months post-treatment
measure: Anagen/telogen ratio
timeFrame: Basal, 1, 2, and 3 months post-treatment
measure: Terminal Hair Density
timeFrame: Before each one of the treatments and 1, 2 and 3 months post-treatment.
measure: Vellous hair density
timeFrame: Basal,1, 2 and 3 months post-treatment
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Clínica Eduardo Anitua.
state: Alava
city: Alicante
country: Spain
facility: Centro dermatológico estético
Study officials:
References:
Clinical trial NCT02742376: Comparison of Gait Parameters Between Floor and Sponge Surfaces and Special Shoes
Official title: Comparison of Gait Parameters Between Floor and Sponge Surfaces and Special Shoes in Individuals With Difficulties in Weight-bearing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroscopic Knee Surgery
Lower Limb Fractures
Back Pain and Asymmetric Gait
Complex Regional Pain Syndrome
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study compares the gait pattern of individuals with weight bearing difficulties walking on the floor, a soft surface, or with special shoes (Kyboot).


Eligibility criteria: Inclusion Criteria:

* 3 days to 1 month following arthroscopic knee surgery(n=10)
* Following fractures in lower limb with pain during weight-bearing (n=10)
* Back pain and asymmetrical gait (n=10)
* Complex Regional Pain Syndrome with pain during weight-bearing (n=10)

Exclusion Criteria:

* Neurological condition that does not permit walking on soft surface (drop foot)
* Wounds on feet

Primary outcomes:
measure: Gait velocity
timeFrame: Two hours
Secondary outcomes:
measure: Step length
timeFrame: Two hours
measure: Base width
timeFrame: Two hours
measure: Cadence
timeFrame: Two hours
measure: Single limb support duration
timeFrame: Two hours
measure: Double limb support duration
timeFrame: Two hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00375076: Comparison of Two Different Dosages of Low-molecular Weight Heparin in Cancer Patients
Official title: Prevention of Venous Thrombosis in Cancer Patients: A Prospective, Randomized, Double-blind Study Comparing Two Different Dosages of Low-molecular Weight Heparin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2006-09-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: In a prospective, randomized, double-blind trial, the effects of two different dosages of LMWH (5000 anti-Xa U od sc and 10 000 anti-Xa U od sc daily) on markers of hemostatic system and thrombin generation will be investigated in non-surgical cancer patients will be investigated.


Eligibility criteria: Inclusion Criteria:

Patients (\> 18 years) with active cancer and at least one of the following indications for thromboprophylaxis with LMWH:

* Immobilization
* History of VTE
* Acute inflammation
* Heart failure (NYHA class III or IV)
* Respiratory failure

Exclusion Criteria:

* Indication for LMWH or UFH at therapeutic dosages
* Treatment with antithrombotics (vitamin K antagonists, acetylsalicylic acid, clopidogrel) for reasons other than prevention of VTE (e.g. atrial fibrillation, myocardial infarction)
* Contraindication for the treatment with LMWH
* Major surgery within the last 4 weeks; minor surgery within the last week
* Thrombocytopenia (\< 100.000/μl)
* Prolonged prothrombin time
* Prolonged activated partial thromboplastin time (aPTT)
* History of heparin-induced thrombocytopenia
* Bodyweight \< 50 kg or \> 100 kg
* Renal insufficiency (creatinine \> 2 mg/dl)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Sabine Eichinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06793176: Vibraimage Technology for Detecting Depression in Psychiatric Outpatients
Official title: Diagnostic Accuracy of Vibraimage Technology for Detecting Depression in a Psychiatric Outpatient Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Beijing HuiLongGuan Hospital
First posted: 2025-01-27
Enrollment: 601
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Psychiatric outpatients attending the Beijing Huilongguan Hospital during the study period.

Brief summary: Vibraimage technology captures high-frame-rate images of head-neck movements, converting them into vibraimages that display muscle vibration amplitude and frequency. Using algorithms and calculations, it derives an emotional index from these images. This non-contact, objective method analyzes psychological indicators through micro-movement detection. An algorithm has been developed to detect depression by calculating 12 emotional and 2 psychophysiological parameters. This diagnostic accuracy study aims to validate the technology's ability to diagnose depression in psychiatric outpatients.


Eligibility criteria: Inclusion Criteria:

* Aged 18 to 70 years.
* No difficulties in reading or writing Chinese; fluent in Mandarin.
* Currently not taking psychotropic medications or on a stable dose for at least 6 weeks.
* Provided informed consent to participate in the study.

Exclusion Criteria:

* Schizophrenia.
* Bipolar disorder.
* History of organic brain disease or significant head trauma.
* Presence of severe systemic medical conditions.
* Suicidal ideation or a score ≥3 on Item 3 ("Suicide") of the 17-item Hamilton Depression Rating Scale (HAMD-17).
* Substance dependence or abuse.
* Intellectual disability or dementia.
* Inability to complete video capture or cooperate due to uncontrollable factors (e.g., hyperactivity, Parkinson's disease, or other conditions that prevent remaining still)

Primary outcomes:
measure: discrimination
timeFrame: Participants undergo video capture and same-day clinical diagnosis by a physician. Video analysis and suggestive diagnosis are completed on the following day.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing HuiLongGuan Hospital
Study officials:
References:
Clinical trial NCT06353776: MicroPulse Transscleral Laser Therapy and Its Short-term Impact on Ocular Surface
Official title: MicroPulse Transscleral Laser Therapy and Its Short-term Impact on Ocular Surface
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conjunctiva
Cornea
Keywords: MicroPulse
transscleral laser therapy
ocular surface
inflammation
fibrosis
glaucoma
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 15
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: MicroPulse transscleral laser therapy (TLT) is proven to be effective in reducing intraocular pressure with minimal complications in either primary or secondary glaucoma. However, its impact on the human ocular surface remains unexplored. This study aims to bridge this gap by examining the clinical and histopathological effects of MicroPulse TLT on the ocular surface.

Detailed description: This prospective study, conducted at Mohamed Taher Maamouri University Hospital in Nabeul, Tunisia, investigates the clinical and histopathological short-term effects of MicroPulse transscleral laser therapy (TLT) on the ocular surface. The study involves 16 eyes from 15 adult patients. Participants underwent MicroPulse TLT, followed by conjunctival biopsies for the analysis of inflammation and fibrosis. Participants also benefited from ophthalmological examination and responded to the Ocular Surface Disease Index (OSDI) questionnaire before and after MicroPulse TLT.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Non-controlled open-angle glaucoma despite undergoing maximal medical therapy
* Poor therapeutic adherence
* Local or general intolerance to topical treatments.

Exclusion Criteria:

* Ophthalmic or general diseases that could potentially impact the conjunctiva such as symblepharon, ocular injury, or prior eye surgery
* Pevious transscleral laser therapy applied to the same eye
* angle-closure glaucoma
* active ocular inflammation
* a non-functional eye (absence of light perception)
* scleral thinning

Primary outcomes:
measure: conjunctival inflammation or fibrosis
timeFrame: 1 month
measure: intraocular pression
timeFrame: 6 months
measure: ocular surface disease index score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nabeul
country: Tunisia
facility: Mohamed Taher Maamouri Hospital
Study officials:
References:
Clinical trial NCT00397176: Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women
Official title: Ascending, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of DVS SR Administered Orally to Healthy Japanese Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vasomotor Symptoms
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-08
Enrollment: 32
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release (DVS SR) in healthy Japanese female subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy, first-generation (born in Japan, living in the US for less than 5 years)
* Japanese female subjects

Primary outcomes:
measure: Safety, Tolerability, PK
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01884376: Clinical Study for the Treatment of Peripheral Nerve Defects With Neuromaix
Official title: Klinische Interventionsstrategie Zur überbrückenden Behandlung Peripherer Nervendefekte Mit Neuromaix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With a Scheduled (Diagnostic) Nervus Suralis Biopsy
Keywords: nerve biopsy
nerve regeneration
neuroma pain
loss of sensation
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is the development and initial clinical application of the nerve guide Neuromaix in humans to provide evidence for the safety and performance of the device.

Neuromaix is intended to be used as a guiding structure to bridge a peripheral nerve discontinuity, and to create a conduit for axonal growth across the nerve gap.

Detailed description: The Neuromaix nerve guide is an absorbable implant composed of porcine collagen, used to bridge a peripheral nerve discontinuity, and to create a conduit for axonal growth across the nerve gap. Neuromaix provides a protective environment for peripheral nerve regeneration after injury. Neuromaix connects the proximal and distal ends of a transected nerve, allowing regenerating axons to grow through the scaffold, into the distal nerve tissue towards the target muscle or skin.

Neuromaix is composed of two parts. The Epimaix part provides the structural characteristics needed to suture the nerve guide in place and to prevent ingrowth of scar tissue. The Perimaix part provides a structure that mimics endoneurial tubes, providing guidance for the regenerating axons while bridging the nerve gap.

Eligibility criteria: Inclusion Criteria:

* both genders in the age between 18 und 70 years
* patients who are scheduled for a nerve biopsy

Exclusion Criteria:

* alcohol-related polyneuropathy
* paraneoplastic polyneuropathy
* present: immunosuppressive therapy
* present: malignant tumor
* peripheral vascular diseases
* collagen diseases (e.g. existing keloid scars)
* patients with an increased wound healing disorder (e.g. diabetics)
* patients with chronic venous insufficiency (vein thrombosis, skin diseases)
* patients with coagulation and bleeding disorders (ASA- or Marcumar-patients)
* present: pregnancy
* HIV, Hepatitis B or Hepatitis C infection

Primary outcomes:
measure: proof of safety of the medical device Neuromaix
timeFrame: 12 months
Secondary outcomes:
measure: effectiveness evaluation of the implant device Neuromaix
timeFrame: 12 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Plastic Surgery, Hand Surgery and Burn Center, University Hospital RWTH Aachen
Study officials:
affiliation: Department of Plastic Surgery, Hand Surgery and Burn Center,University Hospital RWTH Aachen
name: Ahmet Bozkurt, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: