louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06501885: PrEP (Pre-exposure Prophylaxis) Stigma and Women Ethnodrama Pre-Test Phase
Official title: Designing an Ethnodrama Addressing PrEP Stigma Toward Young Cisgender Women in Kenya
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Keywords: Stigma
HIV
PrEP
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Fogarty International Center of the National Institute of Health
First posted: 2024-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigators will develop and pre-test an ethnodrama intervention designed to transform community member beliefs about and foster support of young cisgender women (YCW) using PrEP.

Detailed description: In Aim 1/Year 1, the investigators will develop the ethnodrama intervention; no data collection activities are included. In Aim 2/Year 2, the investigators will pre-test the ethnodrama intervention with invited groups of young women and members of young women's socio ecology (i.e., male partners, female peers, healthcare providers, informal community leaders, and family members).

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Young cisgender women who have taken or are taking PrEP
* Male partners of young women
* Female peers of young women
* Healthcare providers
* Informal community leaders
* Family members of young women

Exclusion Criteria:

None

Primary outcomes:
measure: Number of participants who find the storylines acceptable
timeFrame: Immediately post-intervention
measure: Number of participants who find the interactive components acceptable
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Effect of the intervention's storylines on transforming audience members' PrEP-related perceptions as measured by a brief interviewer-administered survey using the Narrative Transportation Scale (NTS)
timeFrame: Immediately post-intervention
measure: Effect of the intervention's storylines on transforming young women's perceptions of their ability to use PrEP as measured by a brief interviewer-administered survey using the Narrative Transportation Scale (NTS)
timeFrame: Immediately post-intervention
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Impact Research and Development
Study officials:
affiliation: Duke University
name: Amy Corneli, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03524885: Standard Implants With Bone Regeneration vs Short Implants
Official title: Standard Implants With Bone Regeneration vs Short Implants (Implantes Convencionales Con regeneración ósea vs. Implantes Cortos)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implant Complication
Bone Resorption
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 20
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: A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to compare, considering different parameters, the rehabilitation with dental implants of atrophic posterior mandibles or maxillae using short implants or longer implants with vertical bone regeneration with GBR.

The hypothesis of the study is that both treatment options will be successful to rehabilitate atrophic posterior mandibles or maxillae. Moreover, more surgical complications will be encountered in the bone regeneration group.


Eligibility criteria: Inclusion Criteria:

* All the patients with a distal edentulism Kennedy -Applegate Class II in the posterior mandible or maxilla, with residual bone height from the top of the crest to the opposite landmark (the alveolar nerve for the lower and the sinus cavity for the upper) between 5 and 7 millimeters. The bone peak on the last tooth before the edentulous space must be positioned from 2 to 4 mm from the CEJ. (X-ray evaluation by periapical film on a Rinn Holder).
* All patients with at least 3 mm of keratinized tissue on the edentulous crest. In case of absence of this prerequisite, three months before the keratinized tissue is augmented by a ephytelium-connective tissue graft harvested from the palate.
* Patients with edentulous distal sites

Exclusion Criteria:

* Heavy smokers (more than 10 cigarettes /day)
* Patients with active periodontal disease: full mouth plaque index (FMPI \> 20%) and Full mouth bleeding index (FMBI \> 20%).
* Patients with less of 5 mm of bone width.
* Patients with systemic conditions or under prescription of medications that contraindicate oral surgery

Primary outcomes:
measure: Peri-implant bone level changes
timeFrame: 12 months after implant loading
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 12 months after implant loading
measure: Implant survival rate
timeFrame: 12 months after implant loading
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
Study officials:
References:
Clinical trial NCT03905785: Effectiveness of Parenting Intervention for Improving Child Mental Health
Official title: Effectiveness of Parenting Intervention for Improving Child Mental Health: Randomised Single Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior Problem
Conduct Disorders in Children
Mental Health Wellness 1
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Warwick Research Services
name: Balavikasa Educational Academy, India
First posted: 2019-04-05
Enrollment: 86
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, effectiveness of a group parenting intervention was assessed in a community setting, for its impact on child behaviour problems and parental mental health.


Eligibility criteria: Inclusion Criteria:

* Parents who consented to join the trial
* Children aged 2-8 years
* Mean score on the Eyberg Intensity Scale for clinical issues

Exclusion Criteria:

* Any comorbid psychiatric condition in parents or children
* Substance abuse or diagnosed clinical somatic condition influencing ability to consent or follow intervention

Primary outcomes:
measure: Child Problem Behaviour
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: General Health Questionnaire
timeFrame: Changes from baseline to 8 weeks
measure: Parenting stress
timeFrame: Changes from baseline to 8 weeks
measure: Self-esteem
timeFrame: Changes from baseline to 8 weeks
Other outcomes:
Locations:
city: Jaipur
country: India
facility: Gyansanjeevani
state: Rajasthan
Study officials:
affiliation: NMP Medical Research Institute, India
name: Sadhana Sharma, MD
role: STUDY_CHAIR
affiliation: Warwick Research Services
name: Neha Sharma, PhD
role: STUDY_DIRECTOR
affiliation: Balavikasa Educational Academy, India
name: Nagamani Krishnamurthy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04057885: To Determine the Gait and Functional Improvement in Total Knee Arthroplasty
Official title: A PILOT STUDY: To Determine the Gait and Functional Improvement in Total Knee Arthroplasty With Use of Orthosensor™ VERASENSE™ Knee System for Soft Tissue Balancing.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Degenerative Arthritis
Lead sponsor: LifeBridge Health
Sponsor class: OTHER
Collaborators: name: Orthosensor, Inc.
First posted: 2019-08-15
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an observational study to understand the effects of soft-tissue balancing on gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty

Detailed description: The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and to correlate Intra-operative subjective feel with OrthoSensor Outputs

Secondary objectives are to quantify and observe pain medication use, swelling, muscle strength and girth, gait efficiency, patient satisfaction, activity levels, functional return (i.e., back to work, resume normal activities) and patient perception of a balanced knee

Eligibility criteria: Inclusion Criteria:

* Subject must be a candidate for a primary PCL retaining total knee arthroplasty
* Subject must be diagnosed with one or more of the following conditions:

  1. osteoarthritis
  2. avascular necrosis
  3. rheumatoid or other inflammatory arthritis
  4. post-traumatic arthritis Minimum age: 45 Maximum age: 80
* Subject is likely to be available for all study visits
* Subject is able and willing to sign the informed consent and follow study procedures

Exclusion Criteria

1. Prior total knee arthroplasty
2. ligament insufficiencies
3. prior surgeries such as:

   1. ACL or PCL reconstructions
   2. posterolateral reconstructions
   3. osteotomies
   4. tibia plateau fractures
   5. Range of Motion less than 90 degrees f ) flexion contracture of more than 20 degrees

Primary outcomes:
measure: Proportion of patients with improvement in gait.
timeFrame: 18 months
measure: Proportion of patients not requiring long term rehabilitation.
timeFrame: 18 months
measure: Proportion of patients with improved function as measured by standardized knee scores.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
Study officials:
affiliation: Director, Rubin Institute for Advanced Orthopedics and Joint Preservation
name: Michael A. Mont, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01086085: A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive
Official title: A Study on Optimizing the Treatment in HBeAg Positive CHB Patients With Response Guide Treatment (RGT) Method.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Major Science and Technology Special Project of China Eleventh Five-year
First posted: 2010-03-12
Enrollment: 265
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: This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a \[PEGASYS\] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is \>2 years.


Eligibility criteria: Inclusion Criteria:

* Adult patients \>/=18 years of age
* HBeAg positive chronic hepatitis B
* Compensated liver disease

Exclusion Criteria:

* Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
* Antiviral, anti-neoplastic or immunomodulatory treatment
* Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
* Evidence of decompensated liver disease
* Chronic liver disease other than viral hepatitis

Primary outcomes:
measure: Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)
timeFrame: Weeks 72, 96, 120
Secondary outcomes:
measure: Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml
timeFrame: Weeks 24, 48, 72, 96, 120
measure: Safety: Adverse Events
timeFrame: From baseline to Week 120
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Changchun
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Wuhan
country: China
city: Xi'an
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Sun J, Ma H, Xie Q, Xie Y, Sun Y, Wang H, Shi G, Wan M, Niu J, Ning Q, Yu Y, Zhou H, Cheng J, Kang W, Xie Y, Fan R, Wei L, Zhuang H, Jia J, Hou J. Response-guided peginterferon therapy in patients with HBeAg-positive chronic hepatitis B: A randomized controlled study. J Hepatol. 2016 Oct;65(4):674-682. doi: 10.1016/j.jhep.2016.05.024. Epub 2016 May 26.
Clinical trial NCT02818985: Analgesia in Knee Arthroscopic Surgery
Official title: Intra-articular Dexamethasone vs Intra-articular Dexamedetomidine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pain relief in knee Arthroscopic Surgery is essential for rapid recovery of function.

Detailed description: Intra-articular analgesia is useful in reducing patients' postoperative disability. It anticipates and prevents the onset of pain, and helps avoid the need for additional drugs. Usually it is possible to reach good analgesia in the immediate postoperative period by the administration of analgesic drugs. Recently, intra-articular administration of different anaesthetic substances with a local action (e.g. bupivacaine) has been introduced in clinical practice. The aim of the administration of these substances should not be the reduction of postoperative pain, but its prevention.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for knee arthroscopy under spinal anaesthesia

Exclusion Criteria:

* Diabetes Mellitus
* Contraindication to spinal anesthesia
* Patient refusal

Primary outcomes:
measure: pain free time
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Seham Mohamed Moeen Ibrahim
Study officials:
affiliation: Assiut Univerisity
name: Seham M Moeen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moeen SM, Ramadan IK, Elkady HA. Dexamethasone and Dexmedetomidine as an Adjuvant to Intraarticular Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery: A Randomized Trial. Pain Physician. 2017 Nov;20(7):671-680.
Clinical trial NCT00642785: Activation of Alternative Cellular Energy (ACE) Pathway in the Therapy of Herpes Virus Infections
Official title: A Research Study Examining the Effectiveness of Distant Activation of ACE Pigments Associated With Recurrent Human Herpes Simplex Virus-Induced Skin Lesions.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Simplex
Herpes Zoster
Keywords: herpes
HSV
zoster
HZV
shingles
Lead sponsor: Institute of Progressive Medicine
Sponsor class: OTHER
First posted: 2008-03-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HSV and HZV infected patients

Brief summary: The research question to be addressed is whether indirect phototherapy based activation of the body's alternative cellular energy (ACE) pathway will lead to expedited healing of active herpes simplex virus (HSV) and herpes zoster virus (HZV)skin lesions, and also possibly inhibit both latent HSV infections and residual HZV infections.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of active, latent or residual HSV or HZV infection

Exclusion Criteria:

* Unwilling or unable to provide Informed Consent

Primary outcomes:
measure: Expedited healing of active lesions
timeFrame: Within 1 day following therapy
Secondary outcomes:
measure: Recurrence of lesions and/or symptoms
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Progressive Medicine
name: W John Martin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin WJ, Stoneburner J. Symptomatic relief of herpetic skin lesions utilizing an energy-based approach to healing. Exp Mol Pathol. 2005 Apr;78(2):131-4. doi: 10.1016/j.yexmp.2004.10.007. Epub 2005 Jan 5.
Clinical trial NCT00937885: Consequences From Use of Reminiscence: a Randomised Intervention Study in Ten Danish Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Consequences for Nursing Home Residents and Staff of Integrating Reminiscence Into Daily Nursing Care.
Keywords: Reminiscence
Nursing home staff
Nursing home residents
Elderly
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Nørrebro Erindringscenter - the Danish Centre for Reminiscence
name: VIA University College
First posted: 2009-07-13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Reminiscence is the systematic use of memories and recollections to strengthen self-identity and self-worth. The study aim was to investigate the consequences for nursing home residents and staff of integrating reminiscence into daily nursing care. Ten nursing homes were randomised into either an Intervention Group, who implemented reminiscence, or a Control Group, who continued with usual care. Data were collected at baseline and again 6 and 12 months after the intervention start. Results suggested that use of reminiscence can improve residents' quality of life and possibly delay progression in dementia symptoms. Nursing staff can experience greater satisfaction with personal and professional roles and develop a more positive view of the residents.


Eligibility criteria: Inclusion Criteria:

* nursing homes in the Mid-Jutland Region with at least one 35 residents who were willing to particpate in study
* signed informed consent from residents/relatives

Exclusion Criteria:

* nursing homes that already used reminiscence on a systematic basis
* nursing homes with recent organisational changes/extensive staff training
* residents in protected-environment units, were bed-ridden/terminally ill or on short-term placement.

Primary outcomes:
measure: Nurses' attitudes towards professional role and contact with residents
timeFrame: 1 year
Secondary outcomes:
measure: Residents' quality of life (proxy assessment)
timeFrame: 1 year
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: CAST - Centre for Applied Health Services Research & Technology Assessment, University of Southern Denmark
Study officials:
References:
Clinical trial NCT00907985: A Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects
Official title: Double Blind, Double-dummy, Randomised, Placebo Controlled Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Bipolar Disorder
Keywords: Healthy Volunteer
Resting motor threshold (rMT)
Transcranial magnetic stimulation (TMS)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-05-25
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of drug A on its own and when it is given in combination with drug B on markers of brain activity. The study will

1. Assess the effects of drug A and drug B on muscle movement after brain stimulation;
2. Examine how the body handles (absorbs, distributes, breaks down and gets rid of) drug A and drug B when given in combination;
3. Examine the safety of drug A and drug B when given together.


Eligibility criteria: Inclusion Criteria:

* Healthy subject
* Male aged 18-65
* Greater than 50kg weight
* BMI 19-29.9 kg/m2

Exclusion Criteria:

* Positive drug/alcohol screen
* Positive HIV antibody
* History of drug dependence
* History of neurological disease
* Pacemaker
* Smoker

Primary outcomes:
measure: Effect of the study treatments on Resting Motor Thresholds (rMT)
timeFrame: Within 24 hours
Secondary outcomes:
measure: The safety and tolerability of the combination of study treatments.
timeFrame: Within 24 hours
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00239785: Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
Official title: A One-year, Multicenter, Partially Blinded, Double-dummy, Randomized Study to Evaluate the Efficacy and Safety of FTY720 Combined With Reduced-dose or Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids, in de Novo Adult Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Keywords: Transplantation, kidney, and organ transplant.
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 684
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant


Eligibility criteria: Inclusion Criteria

* Male and female patients of any race between 18 to 65 years old (inclusive)
* Patients scheduled to undergo a primary cadaveric or primary non-HLA identical living donor kidney transplantation
* Patients who gave written informed consent to participate in the study Exclusion Criteria
* Recipients of multi-organ transplantation or foreseen to receive a non-renal allograft during the study period
* Graft cold ischemia time greater than 40 hours.
* Patients with pulse rate \< 50 beats per minute (bpm) at screening Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
measure: Permanent resumption of dialysis within 12 months post transplant
measure: Surgical removal of graft within 12 months post transplant
measure: Death within 12 months post transplant
measure: Withdrawal of consent, death, or lost to follow up within 12 months post transplant
Secondary outcomes:
measure: FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
measure: Serum creatinine
measure: Cystatin C at months 3, 6, and 12
measure: Proteinuria at day 28, months 6 and 12
measure: Absolute lymphocyte count at screening, baseline, day 1, 7, 14, and 28, months 2, 3, 6, 9, and 12
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: