louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00500487: Therapeutic Schools: Affect Management and HIV Prevention
Official title: Therapeutic Schools: Affect Management and HIV Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV prevention
HIV seronegativity
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: University of Chicago
First posted: 2007-07-12
Enrollment: 420
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Adolescents are at risk for HIV because of sexual and drug behavior intiated during this developmental period. Those with psychological distress are less likely than their peers to benefit from frequently used skills-based interventions. It appears that emotional lability during sexual situations disrupts skills learned. This project will implement and evaluate interventions for adolescents with psychiatric disorders who are in therapeutic school settings. Affect management and skills-based interventions will be compared to a didactic standard of care condition to determine which intervention best reduces risk behavior among adolescents with psychiatric disorders in therapeutic school settings.


Eligibility criteria: Inclusion Criteria:

* Adolescent attending therapeutic school

Exclusion Criteria:

* Adolescent is HIV positive
* Adolescent is developmentally delayed
* Adolescent is pregnant
* Adolescent has a history of sexual crime

Primary outcomes:
measure: Adolescent-reported condom use
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Larry K Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown LK, Whiteley L, Houck CD, Craker LK, Lowery A, Beausoleil N, Donenberg G. The Role of Affect Management for HIV Risk Reduction for Youth in Alternative Schools. J Am Acad Child Adolesc Psychiatry. 2017 Jun;56(6):524-531. doi: 10.1016/j.jaac.2017.03.010. Epub 2017 Mar 31.
Clinical trial NCT06020287: The Robot-Assisted Laparoscopic Radical Prostatectomy Combined Anterior and Posterior Approach
Official title: The Early Therapeutic Efficacy of The Robot-Assisted Laparoscopic Radical Prostatectomy Combined Anterior and Posterior Approach: A Single-Center Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatectomy
Prostate Neoplasm
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 233
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The clinical data of 233 patients treated between September 2020 and May 2022 at Nanjing Drum Tower Hospital were retrospectively analyzed.

Brief summary: The goal of this observational study was to compare the perioperative outcomes, postoperative urinary control rates and positive surgical margin (PSM) rates of the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach (AP-RARP) with the Retzius-sparing approach (RS-RARP) and anterior approach (anterior-RARP) in the treatment of prostate cancer. The main question it aims to answer was:

• The early therapeutic efficacy of the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach

Participants has been underwent:

* AP-RARP
* RS-RARP
* anterior-RARP Researchers compared the three groups to see if AP-RARP combines the advantages of anterior and posterior RARP and is a feasible surgical option for the treatment of prostate cancer.


Eligibility criteria: Inclusion Criteria:

* pathologically diagnosed with prostate cancer by prostate biopsy
* underwent robot-assisted laparoscopic surgery
* the surgery performed by Weidong Gan
* the extended pelvic lymphadenectomy (PLA) is performed on patients with high-risk prostate cancer (PSA≥20 ng/ml or Grade Group 4-5 or clinical stage ≥T2c) and those considered to have a possibility of lymph node metastasis based on imaging evaluation.

Exclusion Criteria:

* Patients with a clinical and pathological TNM stage ≥T3b and N1
* patients with distant metastasis
* urinary incontinence before surgery
* received neoadjuvant therapy before surgery

Primary outcomes:
measure: urinary continence
timeFrame: 0-6 month after surgery
measure: positive surgical margin
timeFrame: 2 weeks after surgery
Secondary outcomes:
measure: operating time
timeFrame: the day of the surgery
measure: intraoperative blood loss
timeFrame: the day of the surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References:
Clinical trial NCT01979887: Characterization of Signs and Symptoms of Participants With and Without Meibomian Gland Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meibomian Glands
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-11-08
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants characterized as with or without Meibomian Gland Dysfunction.

Brief summary: This is an exploratory study to evaluate endpoints used to characterize participants with and without meibomian gland dysfunction (MGD) and will evaluate the correlation between signs and symptoms of MGD. No investigational drug will be administered in this study.


Eligibility criteria: Inclusion Criteria:

-Participants characterized as with or without Meibomian Gland Dysfunction.

Exclusion Criteria:

* Lid heating therapy, therapeutic gland expression, or meibomian gland probing within 12 months of enrollment
* Contact lens use in the 30 days prior to enrollment
* Lid hygiene within 48 hours prior to enrollment
* Use of eye makeup within 8 hours of enrollment
* Eyelash growth-stimulating products within 30 days prior to enrollment
* Use of systemic vitamins and/or systemic supplements containing omega 3 fatty acids within 60 days of enrollment
* Use of systemic anti-histamines within 30 days prior to enrollment.

Primary outcomes:
measure: Meibum Quality Score in the Study Eye as Assessed by the Investigator Using a 4-Point Scale
timeFrame: Day 22
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
state: Texas
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06759987: Construction and Application of a Self-Care Behavior Intervention Scheme for Chronic Heart Failure Patients Based on Interaction Model of Client Health Behavior
Official title: Construction and Application of a Self-Care Behavior Intervention Scheme for Chronic Heart Failure Patients Based on Interaction Model of Client Health Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Self-care
Health Education
Lead sponsor: Henan University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study, which will last for 3 months, is to investigate the effect of the intervention based on the interaction model of health behavior on patients' disease perception, heart failure self-care level, quality of life and service satisfaction. If you have any questions or difficulties, you can withdraw from this study at any time, which will not affect your treatment and care; The purpose of this study is to improve your level of self-care, prevent your readmission to the hospital, and do not harm your physical and mental health, nor negatively affect the patient's relationship with care; Your participation in the study and the personal data in the study are confidential, and any public report on the results of this study will not disclose your personal identity.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with CHF according to the New York Heart Association (NYHA) functional classification of II-III.
* Age ≥ 18 years, stable condition, clear consciousness, normal language and written expression abilities, no communication barriers, able to understand and accurately complete questionnaires.
* Informed consent and voluntary participation.

Exclusion Criteria:

* -Patients with complications such as renal or hepatic insufficiency, a history of mental disorders, or currently experiencing mental disorders, or critically ill.

Primary outcomes:
measure: Chinese Version of the Self-Care of Heart Failure Index (SCHFI)
timeFrame: Baseline, one month and three months
Secondary outcomes:
measure: Brief Illness Perception Questionnaire (BIPQ)
timeFrame: Baseline, one month and three months
measure: Minnesota Living with Heart Failure Quality of Life Questionnaire (MLHFQ)
timeFrame: Baseline, one month and three months
Other outcomes:
measure: Unplanned Readmission
timeFrame: one month and three months
Locations:
city: Kaifeng
country: China
facility: Institute of Nursing and Health, School of Nursing and Health,Henan University
state: Henan
Study officials:
References:
Clinical trial NCT06050187: Accuracy of 3-dimensional Printed Implant Cast Versus Conventional Stone Cast for Edentulous Mandibular Arch
Official title: Accuracy of 3-dimensional Printed Implant Cast Versus Conventional Stone Cast for Edentulous Mandibular Arch: A Comparative Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Prosthesis Durability
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will be conducted to compare between accuracy of 3D printed implant cast produced from digital impression and conventional stone cast produced from conventional splinted open tray impression for edentulous mandibular arch with four implants.


Eligibility criteria: Inclusion Criteria:

* • Patients were healthy and free from all systemic diseases that affect osseointegration or bone resorption around the implant as recorded from medical and dental history.

  * Patients were free from all oral pathological conditions and any remaining roots which were verified by pre-operative panoramic radiograph.
  * Patients with U shaped arch, flat mandibular alveolar ridge covered with even compressibility healthy mucosa and gingival thickness of about 2mm verified by dual scan of cone beam computed tomography (CBCT) during treatment planning. Fig.(1)
  * Adequate residual alveolar bone quality D2 bone type in the anterior and premolar regions according to the Misch bone density classification scheme (850 to1250 housefield units) confirmed by CBCT.
  * Angel's class I maxillomandibular relation with moderate inter- arch space (20 mm) confirmed through tentative jaw relationship, and restorative space of at least 15 mm determined by putty index technique
  * Patients complain from poor retentive mandibular denture seeking for alternative fixed options.
  * Patient who is motivated, agreed with the follow-up visits and willing to return for follow-up appointments.

Exclusion Criteria:

* • Patient with absolute contraindications that interfere with surgical placement and osseointegration of implants as uncontrolled diabetes mellitus, generalized osteoporosis, recent myocardial infarction, patient with radiotherapy.

  * Patient with relative contraindication such as UN controlled diabetes mellitus, moderate smoking and alcoholism, patient with TMJ disorder and heavy smokers for more than10 cigarettes per day.
  * Patient with local contra indication as insufficient bone quality, localized lesion in canine area and premolar area, unfavourable position of the lower alveolar or mental nerve, bone defects as verified by cone beam CT.
  * Uncooperative patient.

Primary outcomes:
measure: accuracy of 3D printed casts
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia
Study officials:
References:
Clinical trial NCT06325787: Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma
Official title: Long-term Comparison of Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma: A Multicenter Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Papillary Thyroid Cancer
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 1021
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma


Eligibility criteria: Inclusion Criteria:

1. solitary papillary thyroid carcinoma confirmed by fine-needle aspiration or core-needle biopsy;
2. largest diameter ≤10 mm;
3. no evidence of extrathyroidal extension( no signs of unsmooth thyroid capsule or involvement of the perithyroidal tissue) on ultrasound;
4. no evidence of cervical lymph node metastasis on US or neck CT;
5. no distant metastasis on chest CT;
6. no history of neck irradiation.

Exclusion Criteria:

* (1)aggressive subtype of papillary thyroid microcarcinoma confirmed by biopsy(1); (2)multiple tumors; (3) incomplete data or lost follow-up

Primary outcomes:
measure: disease progression
timeFrame: more than 5 years
measure: disease-free survival
timeFrame: more than 5 years
Secondary outcomes:
measure: complications
timeFrame: 1 week
measure: procedure time
timeFrame: 1 hour after treatment
measure: cost
timeFrame: 1 week
measure: estimated blood loss
timeFrame: 1 hour
measure: hospitalization
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02211287: Promoting Informed Decision Making Through Advance Care Planning
Official title: Promoting Informed Decision Making and Effective Communication Through Advance Care Planning for People With Dementia and Their Family Carers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Neurodegenerative Diseases
Keywords: Dementia
Decision-making
Communication
Advance Care Planning
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Four Seasons Health Care
First posted: 2014-08-07
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the application of a best-practice Advance Care Planning (ACP) model for individuals living with dementia in a sample of nursing homes in Northern Ireland


Eligibility criteria: Inclusion Criteria:

1. Family Caregivers

   * Family caregivers of a resident who does not have decision making capacity to participate in ACP discussion
   * Individuals identified by the nursing home manager as the family member who possess power of attorney for personal care and/or viewed by the nursing home staff as most involved in the care of the resident who does not have decision making capacity.
2. Health Care Professionals

Nursing home managers, registered nursing staff and GPs who:

* are employed, or in the case of GPs, care for residents, in the six nursing homes that were part of the intervention group
* were familiar with the intervention to discuss its strengths and weaknesses in an interview
* are able to speak English as they are required to participate in interviews.

Exclusion Criteria:

* Family caregivers and health care professionals who are unable to communicate through written and spoken English.
* Family caregivers who has a family resident considered to have the ability to participate in ACP discussions.

Primary outcomes:
measure: Level of family carer satisfaction in decision making about the care of the resident
timeFrame: Baseline, up to 2 months
Secondary outcomes:
measure: The level of family carer satisfaction with nursing home care
timeFrame: Baseline up to 2 months
measure: Level of family carer anxiety and depression
timeFrame: Baseline up to 2 months
measure: The comfort of the resident at the end of life
timeFrame: Baseline up to 2 months
measure: Number of unnecessary hospitalisations
timeFrame: Baseline up to 12 months
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Four Seasons Health Care -- Nursing Homes
Study officials:
affiliation: Queen's University, Belfast
name: Kevin Brazil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01675687: Web Based Follow up Intervention in Obesity Treatment for Women
Official title: Effects on Self-efficacy, Sustainability and Drop Out Rate Using Web Based Follow up Intervention in Obesity Treatment for Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: dietary habits and obesity
exercise habits and obesity
cognition and obesity
Lead sponsor: FEM Süd
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to verify that web based follow up intervention after a classic multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise self-efficacy, improve drop out rate and advance sustainability after weight loss of obese women.

Research Questions and Hypotheses

* How does a web based follow up intervention change self-efficacy of women participating in an obesity intervention?
* How does a web based follow up intervention affect the drop out rate of women participating in an obesity intervention?
* How does a web based follow up intervention influence sustainability of women participating in an obesity intervention?


Eligibility criteria: Inclusion Criteria:

* Women
* Age 18-80
* BMI 30-40
* Internet access
* Motivation and psychological stability to stay in a long term obesity intervention
* No medical conditions prohibiting moderate physical exercise

Exclusion Criteria:

* Men
* Age under 18 years
* BMI under 30 and above 40
* No Internet access
* No motivation and psychological stability to stay in a long term obesity intervention
* Medical conditions prohibiting moderate physical exercise

Primary outcomes:
measure: Changes in nutrition- and exercise self-efficacy
timeFrame: Primary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
Secondary outcomes:
measure: Dropout rate
timeFrame: Secondary outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
Other outcomes:
measure: Sustainability of weight loss
timeFrame: Further outcome measure is assessed at the beginning of the follow up support (baseline) and after 6 months (at completion of the follow up intervention by Internet or printed manual)
Locations:
city: Vienna
country: Austria
facility: FEM Süd
Study officials:
affiliation: FEM Süd
name: Sonja Rader, Mag.a
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00097487: A Study of Patients With HER2 Gene Amplified Metastatic Breast Cancer Treated With First Line Herceptin and a Taxane
Official title: Clinical Outcomes in Patients With HER2 Gene-Amplified Metastatic Breast Cancer Treated With First Line Herceptin in Combination With a Taxane: A Phase IV, Prospective, Community Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Metastases
Keywords: Metastatic Breast Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-25
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This study is a Phase IV, prospective, nonrandomized, community-based study of clinical outcomes in patients with metastatic breast cancer treated with Herceptin and a taxane.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Available tissue for central laboratory evaluation of HER2 status
* Histologically confirmed, measurable or nonmeasurable but evaluable, HER2 positive metastatic breast cancer (HER2 positive is defined as 3+ staining by IHC or gene amplification by FISH, determined by the local or central laboratory)
* Life expectancy \>6 months
* Female, age \>=18 years
* ECOG performance status of 0, 1, or 2
* Adequate bone marrow function as indicated by the following: \*ANC \>1500/uL, \*Platelet count \>=100,000/uL
* Adequate renal function, as indicated by creatinine \<=1.5× upper limit of normal (ULN)
* Adequate liver function, as indicated by bilirubin \<=1.5× ULN and AST or ALT \<2× ULN unless related to primary disease
* Use of an adequate means of birth control (women of childbearing potential)

Exclusion Criteria:

* Initiation of Herceptin \>=4 weeks after beginning taxane chemotherapy
* Prior chemotherapy for metastatic disease
* Prior cumulative anthracycline dose of \>360 mg/m2
* History of significant cardiac disease or uncontrolled arrhythmias
* Ejection fraction of \<50% or below the lower limit of normal
* Active infection
* Symptomatic or untreated brain metastases
* Pregnancy or lactation
* Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest
* Hypersensitivity to study medications
* Major organ failure or systemic disease precluding the safe administration of study medications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: