louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04338295: Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
Official title: Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alopecia Areata
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The investigators propose to study the efficacy of micro-needling via the SOL Nova Device in generating hair growth in patients with Alopecia Areta (AA) who are either non-responsive or only partially responsive to combination oral JAK inhibitor plus oral minoxidil therapy.

Detailed description: This will be a trial evaluating the efficacy of micro-needling via tattoo device in stimulating scalp hair growth in patients with AA refractory to combination JAK inhibitor and oral minoxidil treatment. Ten healthy subjects who are at least eighteen years of age who have experienced no or partial scalp hair regrowth after ≥three months of JAK inhibitor plus oral minoxidil treatment will be enrolled. Subjects will undergo a treatment session once every thirty days for a total of six sessions over six months and will complete a total of eight visits over eight months. Procedures and visits are not standard of care but conducted for research. Each visit will last about an hour. Approximately 30 minutes will be spent on consenting and time for patient to ask questions during the first visit. The remaining 30 minutes will be allotted for the investigator to determine if the patient meets criteria for trial enrollment. During the remaining visits, 20 minutes will be allotted for photography, 15-20 minutes for the procedure and 10-15 minutes for post-procedure patient assessment. Remaining 10 minutes on visits 2 and 8 will be used for biopsy.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of AA
* SALT score ≥90%
* No or minimal scalp hair regrowth after ≥three months of oral JAK inhibitor plus oral minoxidil treatment

Exclusion Criteria:

* Known concomitant androgenetic or other form of alopecia (in addition to AA)
* Patients with the following who would make poor candidates for microneedling such as skin conditions, diabetes, or history of keloid formation
* Anything additional existing comorbidities that in the opinion of the investigator may cause unnecessary risk for the patient to participate

Primary outcomes:
measure: Target area hair count (TAHC)
timeFrame: 6 months
Secondary outcomes:
measure: Hair phase
timeFrame: 6 months
measure: Vellus hairs
timeFrame: 6 months
measure: Terminal hairs
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Associate Professor of Dermatology, Yale University
name: Brett King, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01733095: Ambrisentan for Treatment of Portopulmonary Hypertension
Official title: Ambrisentan for Treatment of Portopulmonary Hypertension (PoPH): a Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Portopulmonary Hypertension
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 0
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: Portopulmonary hypertension denotes pulmonary hypertension complicating portal hypertension and is present in approximately 5% of cirrhotic patients. Treatment options include prostanoids, sildenafil, and the endothelin-receptor antagonists, bosentan and ambrisentan.

This study investigates the safety and efficacy of ambrisentan in portopulmonary hypertension.

Detailed description: Patients with clinically significant PoPH (resting mean pulmonary arterial pressure \>25 mm Hg, pulmonary vascular resistance \>400 dynes\*s\*cm-5) will be offered treatment with ambrisentan. Patients will be followed clinically and hemodynamically up to 12 months after start of treatment.

Eligibility criteria: Inclusion Criteria:

* Adult patients with portal hypertension, age \>18 years
* Cirrhosis of any etiology; Child-Pugh class A and B
* Noncirrhotic portal hypertension (e.g. chronic portal vein thrombosis)
* Informed consent

Exclusion Criteria:

* Presence of other causes for pulmonary arterial hypertension
* History of pulmonary embolism or myocardial infarction within 6 months before study start
* Child-Pugh class C
* Presence of hepatocellular carcinoma
* Liver transplantation
* HIV infection
* Severe obstructive or restrictive pulmonary disease (predicted FEV1 or VC \<65%, respectively)
* Severe dilated cardiomyopathy (EF \<50%)
* Latent left-heart insufficiency
* Pregnancy and lactation
* Esophageal variceal hemorrhage within the last 6 months
* Refractory ascites
* Hepatorenal syndrome
* Persistent hepatic encephalopathy \> grade 1
* Bilirubin \>3.0 mg/dl
* AST and/or ALT \>3x ULN
* Creatinine \>2.0 mg/dl
* Known hypersensitivity to ambrisentan

Primary outcomes:
measure: pulmonary vascular resistance
timeFrame: week 24
Secondary outcomes:
measure: mean arterial pulmonary pressure
timeFrame: week 24
measure: hepatic venous pressure gradient
timeFrame: week 24
measure: exercise capacity
timeFrame: week 24, 48
measure: quality of life
timeFrame: week 24, 48
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Gastroenterology & Hepatology
name: Rudolf E. Stauber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulmonology
name: Horst Olschewski, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00651495: Activating Seniors to Improve Chronic Disease Care
Official title: Activating Seniors to Improve Chronic Disease Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Decision aids
Seniors
Chronic disease management
Advance directives
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Foundation for Informed Medical Decision Making
First posted: 2008-04-02
Enrollment: 116
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Chronic diseases are the primary cause of morbidity and mortality for older Americans. Active patient participation in treatment decision-making has the potential to significantly improve outcomes in chronic disease care, but interventions to increase participation remain underused. Some studies have found that older individuals are less interested in participating in clinical decision-making, but other studies find that exposing patients to decision aids (PtDAs) increases their desire to take an active role in making decisions with their physicians. The present study targets hard-to-reach seniors by showing decision aids focused on chronic disease management in senior centers. Decision aids will be made available in two senior centers through a lending library and by conducting group screenings of the decision aids followed by moderated discussion of the content with participants. A randomized encouragement design will be used to test the effectiveness of a modest financial incentive on increasing seniors' participation in group screenings. The investigators will evaluate the effects of the intervention on seniors' decision-making role preferences, attitudes, perceived social norms and self efficacy for asking questions of their physician, health-related quality of life, physical activity, and changes in prescribed treatment regimens and self-care.


Eligibility criteria: Inclusion Criteria:

* At least 55 years old.
* Able to ambulate
* Able to complete self-administered surveys
* Able to speak and read English

Exclusion Criteria:

* Not willing to provide consent

Primary outcomes:
measure: Decision-making role preferences
timeFrame: 20 weeks
measure: Attitudes, perceived social norms and self efficacy for asking questions of a physician
timeFrame: 20 weeks
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Culver City Senior Center
state: California
city: Los Angeles
country: United States
facility: Willowbrook Senior Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Dominick L Frosch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frosch DL, Rincon D, Ochoa S, Mangione CM. Activating seniors to improve chronic disease care: results from a pilot intervention study. J Am Geriatr Soc. 2010 Aug;58(8):1496-503. doi: 10.1111/j.1532-5415.2010.02980.x. Epub 2010 Jul 19.
Clinical trial NCT06145295: The Effectiveness of an Online Support Group in Enhancing Recovery Identity and Health-Related Quality of Life
Official title: Understanding the Effectiveness of an Online Support Group in Enhancing Recovery Identity and Health-Related Quality of Life of Middle-aged and Older Ovarian Cancer Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 68
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background Ovarian cancer poses challenges for middle-aged and older patients, impacting physical and self-conceptual aspects. A research gap exists on the impact of online support groups (SPs) on identity synthesis and Health-Related Quality of Life (HRQOL) for these patients.

Objective To assess the feasibility and efficacy of an online SG in influencing recovery identity and HRQOL in middle-aged and older ovarian cancer patients (MDOCP).

Method A four-week randomized controlled trial, followed by a three-month evaluation, was conducted, employing a mobile online SG and an offline SG both grounded in The Social Identity Model of Identity Change. Recovery identity, HRQOL, and participant engagement were utilized to evaluate the feasibility and efficacy of interventions.


Eligibility criteria: Inclusion Criteria:

* Older than 44 years old
* diagnosis of ovarian cancer
* expected survival time of greater than four months
* fluent in using smartphones and the WeChat mini program
* normal cognitive function
* capability to participate in follow-up surveys.

Exclusion Criteria:

* were currently participating in or had previously participated in other mental treatment groups
* had been diagnosed with any other type of cancer.

Primary outcomes:
measure: Illness identity
timeFrame: Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up
measure: Maintenance of identity
timeFrame: Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up
measure: New identity
timeFrame: Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up
Secondary outcomes:
measure: Health related quality of life
timeFrame: Data collection occurred at three time points: before the intervention, immediately after the intervention, and at a three-month follow-up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong Universiy
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Ting Han, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03225495: Comparison Between Ultra-narrow Diameter Implants (2,75 mm) Without Bone Regeneration Versus Standard Diameter Implants (4,3 mm) in Combination With Bone Regeneration
Official title: Éxito a Corto Plazo de Los Implantes Ultra-estrechos (2,75 mm) en comparación Con Implantes de Plataforma Regular (4,3 mm) Que Requieren regeneración ósea Vestibular simultánea. Ensayo clínico Aleatorizado
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant
Narrow Implant
Implant Fracture
Guided Bone Regeneration
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Adin Implants
name: Geistlich Pharma AG
First posted: 2017-07-21
Enrollment: 40
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 main target of the study is to compare ultra-narrow diameter implants (2.75 mm) without bone regeneration versus standard diameter implants (4.3 mm) in combination with bone regeneration. To do so, patients with missing upper central incisors, canines, first or second premolars with alveolar ridges of 6 - 8 mm of thickness will be restored with dental implants. Cone beam computed tomographic examination and clinical values will be registered before and after the surgical procedure at 6 and 12 months.


Eligibility criteria: Inclusion Criteria:

* One missing teeth in position: upper central incisor, canine or premolar
* alveolar ridge thickness of 6 - 8 mm
* alveolar ridge height of ≥ 10 mm

Exclusion Criteria:

* Missing data
* ASA ≥ III

Primary outcomes:
measure: Success
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Odontològic - Universitat de Barcelona
Study officials:
References:
Clinical trial NCT06753695: Prevalence of Hypomineralized Second Primary Molars and Their Association with Dental Hypersensitivity in Egyptian Children
Official title: Prevalence of Hypomineralized Second Primary Molars(HSPM) and Its Association with Dental Hypersensitivity in a Group of Egyptian Children: a Cross-sectional Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypomineralized Second Primary Molars
Dental Hypersensitivity
Keywords: HSPM
DH
hypo-mineralized second primary molars
hypomineralized E
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 825
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: a group of gentian children aged form4 to 9 years old

Brief summary: hypomineralized second primary molars and dental hypersensitivity in a group of Egyptian children

Detailed description: the prevalence of the condition of hypomineralized second primary molars in a group of Egyptian children and the association of this condition to dental hypersensitivity.

Eligibility criteria: Inclusion Criteria:

* Egyptian children
* cooperative patients both genders and included 4-9 years old children at least one HSPM affected molar and one non affected molar absence of syndromes or craniofacial anomalies

Exclusion Criteria:

* other developmental defects(amelogensis imperfecta ...) children ongoing anti-inflammatory drugs children who caregiver will not sign the informed consent

Primary outcomes:
measure: EAPD scoring criteria and wurzberg scroring system
timeFrame: 1 year
Secondary outcomes:
measure: VAS scale and SCASS scale
timeFrame: 1year
Other outcomes:
Locations:
Study officials:
affiliation: University of Cairo, Department of Dentistry.
name: Aya M Ibrahim, B.D.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06055595: Genetic Factors and CP Pregnancy Outcomes
Official title: The Impact of Genetic Factors on Pregnancy Outcomes in Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Pancreatitis
Genetic Mutation
Pregnancy Related
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 160
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: There were 292 female patients diagnosed with CP and underwent genetic testing from January 2010 to December 2014 in this cohort. After application of exclusion criteria, a total of 160 patients who had known genetic backgrounds and pregnancy history were enrolled in this study.

Brief summary: To explore the impact of chronic pancreatitis (CP) susceptibility genes on pregnancy outcomes.

Detailed description: The goal of this observational study is to explore the impact of CP susceptibility genes (SPINK1, PRSS1, CTRC, CFTR) on pregnancy outcomes (including both maternal and fetal outcomes) in a large Chinese cohort. Participants will be asked to provide their pregnancy-related data.

Eligibility criteria: Inclusion Criteria:

* female patients with a diagnosis of chronic pancreatitis
* have known genetic backgrounds and pregnancy history
* agree to join the study and provide informed consent

Exclusion Criteria:

* patients without documented pregnancy
* patients who denied to provide pregnancy-related information, or with incomplete pregnancy characteristics and/or outcomes
* patients with other autoimmune comorbidities that might influence pregnancy outcomes, such as systemic lupus erythematosus, autoimmune thyroid diseases, etc

Primary outcomes:
measure: adverse maternal outcomes of female CP patients
timeFrame: through study completion, an average of 1 year
measure: adverse fetal outcomes of female CP patients
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Zhuan Liao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01265095: Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia
Official title: Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacteremia
Keywords: VRE
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-12-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: VRE bacteremia

Brief summary: The investigators hypothesized that quantitative PCR can be used in VRE bacteremia outcome monitoring. Vancomycin-resistant enterococci (VRE) was first found in 1988 and has become an important healthcare-associated pathogen due to rapid spread, limited options for therapy and the possibility of transferring vancomycin resistance to more virulent pathogens. VRE infections not only contribute to more hospital cost and longer length of hospital stay, but also higher attributable mortality compared to those caused by vancomycin susceptible enterococci. Two different meta-analyses have shown that vancomycin resistance is an independent predictor of death among patients with enterococcal bloodstrem infections (BSIs). Despite this, few effective antibiotics are approved by the US Food and Drug Administration for the treatment of serious VRE infections. Though several studies have conducted to find the possible mortality predictors, but none has used bacterial load as a marker.

Schonheyder et al. have used semiquantitative culture, and demonstrate the relationship between high bacterial load and mortality. However, it may take more than two days before culture result available, and the sensitivity of culture is greatly affected by antimicrobial treatment. Real-time PCR has been demonstrate good performance in early detection of bacteremia, and theoretically is less affected by antimicrobial usage. However, using quantitative real-time PCR to quantify VRE in blood has not been explored, yet.

The objective of this study is to establish a quantitative method to measure the amounts of VRE in blood using the VRE specific van gene. And test the hypothesis that higher VRE load in blood results in higher mortality among patients with VRE BSIs.

Primers and probe of VRE Real-time PCR will be constructed first. The investigators will prospective enroll patient with VRE bacteremia. Clinical data and outcome will be monitored. Bacteria load of VRE bacteremia will be measured via established real-time PCR. The outcome and the association of bacteria load of VRE bacteremia will be analyzed.


Eligibility criteria: Inclusion Criteria:

* \>18 y/o
* VRE bacteremia

Primary outcomes:
measure: all cause inhospital mortality
timeFrame: 30days
Secondary outcomes:
measure: VRE DNA load
timeFrame: 14days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: national Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: JannTay Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: