louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03208127: DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant
Official title: Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Liver Transplant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: End Stage Liver Disease
Hepatitis C
Keywords: HCV
Epclusa
ESLD
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

Detailed description: Patients will be selected based on diminished likelihood of receiving a liver from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's Model of End Stage Liver Disease (MELD) score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.

Eligibility criteria: Inclusion Criteria:

* Recipient is Age ≥ 18 years
* Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant
* HCV naïve
* Able to sign informed consent

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Human immunodeficiency virus (HIV) positivity
* Need for dual organ transplant
* Any contra-indication to liver transplantation per center protocol

Primary outcomes:
measure: Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA
timeFrame: 12 weeks post treatment
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Masschusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Raymond Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02706327: Comparison of Two Different Insole Types in Painful Flexible Flatfoot
Official title: Comparison of Two Different Insole Types on Pain, Quality of Life and Physical Performance in Painful Flexible Flatfoot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flatfoot
Keywords: orthotic insoles
pain
quality of life
athletic performance
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2016-03-11
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare computer aided design/computer aided manufacturing (CAD/CAM) and semi-custom insole types on pain, quality of life and physical performance and also to decide whether they are necessary in treatment of painful flexible flatfoot.


Eligibility criteria: Inclusion Criteria:

* minimum subtalar pronation of 5 degrees while standing (tibiocalcaneal angle, measured with goniometer),
* minimum of + 6 points on the foot posture index,

Exclusion Criteria:

* treatment of the foot for at least six months,
* leg length discrepancy of more than 1 cm,
* history of lower extremity surgery, and no disease that could affect lower extremity biomechanics.

Primary outcomes:
measure: Change in Pain Intensity Measured by 100 mm Visual Analog Scale
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Change in Quality of Life Assessed With Short Form-36 Scale
timeFrame: Baseline and week 8
Other outcomes:
measure: Balance Was Assessed With a Dynamic Platform
timeFrame: In the same session after 8 weeks
measure: Six-minute Walk Physiological Cost Index Was Calculated
timeFrame: In the same session after 8 weeks
measure: Vertical Jump Height Was Measured With a Special Mat
timeFrame: In the same session after 8 weeks
Locations:
Study officials:
affiliation: Eastern Mediterranean University
name: Yasin Yurt, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05770427: Evaluating an Online Parenting Intervention in a Community-Based Sample of Parents
Official title: Can We Still Make the Connection? Evaluating an Online Parenting Intervention in a Community-Based Sample of Parents of Infants and Young Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parent-Child Relations
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of the online modality of the Make the Connection (MTC) program in a community-based sample of parents not at-risk for parenting difficulties. The main questions it aims to answer are:

* Does the MTC online program result in improvements in parent-child bond, parent self-efficacy, parental stress, and parental depression among parents who are not at-risk for parent-child relationship difficulties?
* What are some of the barriers, facilitators, perceived benefits and risks to participating in the MTC online program from the perspective of parents?

Participants will be asked to complete a pre-intervention questionnaire, will be invited to complete the 8-week MTC online program consisting of a weekly 15-minute module, and will lastly be asked to complete a post-intervention questionnaire.


Eligibility criteria: Inclusion Criteria:

* parents with children between the ages of 0-3 years old
* parents are primarily responsible for the children

Exclusion Criteria:

* parents are at-risk for parent-child relationship difficulties (i.e., endorse two of the following criteria: being a first-time caregiver, socially isolated, low education, caregiving alone, lack of confidence or self-efficacy, at risk for poor infant sensitivity, or at-risk for depression)

Primary outcomes:
measure: Parent-child bond will be measured using the Maternal Postnatal Attachment Scale (MPAS)
timeFrame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
Secondary outcomes:
measure: Parent self-efficacy will be measured using the Parent Sense of Competence Questionnaire (PSOC)
timeFrame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
measure: Parental stress will be measured using the Parenting Stress Scale (PSS)
timeFrame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
measure: Parental depression will be measured using the Centre for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Change from pre-intervention scores at baseline and post-intervention scores at week 8
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
References:
Clinical trial NCT05483673: Analyzing Orthopedic Patient Experience Patterns in Medical Trials
Official title: A Comprehensive Study for Analyzing Orthopedic Patient Experience Patterns in Medical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Orthopedic Disorder
Keywords: orthopedic
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Orthopedic disorder patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Clinical study enrollment has historically been heavily biased toward specific demographics.

Several people will be invited to participate in this study so that it may collect a variety of data about orthopedic clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with orthopedic disorders who are invited to take part in medical research will benefit from the analysis of the data.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with orthopedic disorder
* Patient has self-identified as planning to enroll in an interventional clinical trial
* Patient is 18 years old

Exclusion Criteria:

* ECOG score of 4
* Patient is pregnant
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form

Primary outcomes:
measure: Number of patients who decide to enroll in an orthopedic clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in orthopedic clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Hollis AC, Davis ET. Understanding the factors that influence patient participation in Orthopaedic Clinical Trials. Int Orthop. 2018 Aug;42(8):1769-1774. doi: 10.1007/s00264-018-3890-2. Epub 2018 Mar 20.
citation: Trippel SB, Bosse MJ, Heck DA, Wright JG. Symposium. How to participate in orthopaedic randomized clinical trials. J Bone Joint Surg Am. 2007 Aug;89(8):1856-64. doi: 10.2106/JBJS.F.01596. No abstract available.
citation: Somerson JS, Bartush KC, Shroff JB, Bhandari M, Zelle BA. Loss to follow-up in orthopaedic clinical trials: a systematic review. Int Orthop. 2016 Nov;40(11):2213-2219. doi: 10.1007/s00264-016-3212-5. Epub 2016 May 3.
Clinical trial NCT00269373: Positron Emission Tomography - Computed Tomography (PET-CT) Scan as a Diagnostic Method in Unknown Primary Tumors
Official title: PET-CT Scan as a Diagnostic Method in Unknown Primary Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unknown Primary Tumor
Keywords: Unknown primary tumor
PET-CT
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-12-23
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unknown tumors

Brief summary: Is PET-CT scan better than PET or CT alone in diagnosing primary tumours in patients with unknown primary tumors? Can information obtained with PET-CT replace other clinical and radiological investigations? Is PET/CT cost-effective?

Detailed description: Patients who fulfill the international definition of unknown primary tumors can be included, except:

* Young men (\<55 years) with growing mid-line tumors where a germ cell tumor could be expected will not be included.
* Patients with lymph-node metastases with squamous cell carcinoma in the head and neck region will not be included.
* Women with adenocarcinoma in lymph nodes in the axilla will not be included.

Eligibility criteria: Inclusion Criteria:

* Unknown primary tumors

Exclusion Criteria:

* Young men (\<55 years) with growing mid-line tumors where a germ cell tumor could be expected will not be included.
* Patients with lymph-node metastases with squamous cell carcinoma in the head and neck region will not be included
* Women with adenocarcinoma in lymph nodes in the axilla will not be included

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Gedske Daugaard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04772573: The Treatment Challenges and Limitation in High-Voltage Pediatric Electrical Burn at Rural Area
Official title: The Treatment Challenges and Limitation in High-Voltage Pediatric Electrical Burn at Rural Area: A Case Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Electrical Burn
Burn Degree Second
Burn Scar
Lead sponsor: S.K. Lerik General Hospital
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with acute electrical burn wound

Brief summary: A case of high-voltage pediatric electrical burn involving a fully conscious 13-year old boy who was admitted to the emergency room after being electrocuted by high-voltage power cable, with superficial partial thickness burn over right arm, trunk, and left leg (26% of total body surface area) with cardiac abnormality e.g. tachycardia and non-specific ST depression. Treatments were based on Australian New Zealand Burns Association algorithm with several modifications, i.e. administering lower concentration of oxygen with nasal cannula instead of non-rebreathing mask and intravenous Ketorolac and Metamizole as analgesic instead of morphine due to limitation in infrastructure and knowledge. The patient underwent surgical debridement and strict observation with no signs of abnormality found during hospital stay. Wound dressing consisted of silver sulfadiazine, Sofra-tulle® and dry sterile gauze were used until epithelialization. After the wound healed, the patient resumed wearing elastic bandage and moisturizer on the wound area. The patient was observed daily through 7 days of hospitalization and followed-up for 1 year, achieving normal physiologic function of the affected area but unsatisfactory esthetic result. This case report showed that there is still a lack of burn prevention programs in the rural area, resulted in inadequate first aid application for electrical burn. There is a need for acknowledging and maximizing the implementation of available standardized guidelines e.g. Australian New Zealand Burns Association by giving homogenized training to personnel as well as providing feasible equipment, and then followed by strict monitoring for the patient. The focus of the burn program should also include burn rehabilitation, psychosocial needs and any complaints needing expert opinion in an outpatient setting in addition to adequate burn management for life saving and good wound healing.


Eligibility criteria: Inclusion Criteria:

* patient with acute electrical burn wound

Exclusion Criteria:

* patient does not want to participate

Primary outcomes:
measure: Wound healing
timeFrame: 1 month
Secondary outcomes:
measure: Burn Scar
timeFrame: 1 year
Other outcomes:
Locations:
city: Kupang
country: Indonesia
facility: S.K.Lerik General Hospital
state: East Nusa Tenggara
Study officials:
affiliation: S.K.Lerik Public Hospital
name: Adi Basuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05952973: The Impact of Online Educator Mircoskill Training and Parent Microskill Training on Student Sexual-Health Related Outcomes
Official title: The Impact of Online Educator Mircoskill Training and Parent Microskill Training on Student Sexual-Health Related Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS Prevention
STI Prevention
Pregnancy Prevention
Lead sponsor: Philliber Research & Evaluation
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to evaluate the impact of SkillTalk among educators, parents, and students. The main question\[s\] it aims to answer are:

* What is the impact of SkillTalk on student sexual-health related outcomes?
* What is the impact of SkillTalk on educator microskills?

Educator participants will use an online microskills training platform for one week. Parent participants will be asked to use a parent-specific online microskills training platform for one week. Youth participants will not be asked to do anything outside of "business as usual." Researchers will compare the treatment groups to the control groups to measure the impact of SkillTalk.


Eligibility criteria: Inclusion Criteria for Educators:

* Have fewer than three years teaching
* Teach youth in a class with at least 8 students
* Be able to obtain supervisor's or administration permission before beginning study
* Agree to be in compliance with district/school regulations about teaching sexual health and participating in a research study
* Agree to administer the assent/consent forms and student surveys.\\

Inclusion Criteria for Students:

* Being in class of teacher who has agreed to participate
* Parental consent
* Assent to participate

Inclusion Criteria for Parents:

* Be the parent/guardian of a youth who has assented to participate
* Consent to their youth's participation
* Consent to view SkillTalk Parent site
* Need to speak English or Spanish
* Access to internet

Primary outcomes:
measure: Condom knowledge
timeFrame: 1 month
measure: Condom use
timeFrame: 1 month
measure: STI knowledge
timeFrame: 1 month
measure: Connectedness
timeFrame: 1 month
Secondary outcomes:
measure: Self-efficacy and comfort with microskills
timeFrame: 1 month
measure: Student impressions of educator skills
timeFrame: 1 month
measure: Frequency of parent-child communication
timeFrame: 1 month
measure: Comfort in parent-child communication
timeFrame: 1 month
measure: Parent-child communication
timeFrame: 1 month
Other outcomes:
Locations:
city: Accord
country: United States
facility: Philliber Research & Evaluation
state: New York
Study officials:
References:
Clinical trial NCT03265873: Contribution of the ENT (Ear, Nose, and Throat) Surgeon's Clinical Evaluation to the Contouring of Target Volumes and Organs Eligible for Radiotherapy in Head and Neck Cancers
Official title: Contribution of the ENT Surgeon's Clinical Evaluation to the Contouring of Target Volumes and Organs Eligible for Radiotherapy in Head and Neck Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiotherapy, Conformal (IMRT)
Head and Neck Cancer
Otolaryngology
Surgeons
Radiation Oncologists
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with head and neck cancer who require radiotherapy.

Brief summary: Radiotherapy (RT), surgery and chemotherapy (CT) are treatments for head and neck cancers, used alone or in combination. Conformal RT with Intensity Modulation (IMRT) is currently the reference technique. IMRT requires a precise definition of the target volumes to be treated and the anatomical structures to be protected from irradiation. Most studies of head and neck cancers published in the literature demonstrate the variability in the contouring of the target volumes between radiotherapists. This may have an impact on dosimetry. To date, no studies have evaluated the impact of the ENT surgeon's evaluation in volumes contouring. The aim of this study is to compare the volumes determined by the radiotherapists alone and those determined jointly by the radiotherapists and the ENT surgeon.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Cancer of the upper aerodigestive tract (oral cavity, oropharynx, larynx, hypopharynx, rhinopharynx, salivary glands, facial sinuses, orbital cavity, ear);
* Cancer confirmed by histopathological analysis;
* Therapeutic protocol including radiotherapy.

Exclusion Criteria:

* Any history of radiotherapy of the head and neck
* Synchronous head and neck cancer.

Primary outcomes:
measure: Proportion of patients with head and neck cancer for whom a change in the CTV (Clinical Target Volume) was made following the advice of the ENT surgeon.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
affiliation: Hôpital d'Instruction des armées Percy
name: Philippe Clément, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02400073: AutoSet for Her Quality of Life Clinical Trial
Official title: Assessment of a New AutoSet Device Designed for Female Obstructive Sleep Apnea Patients on the Quality of Life of Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2015-03-26
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea (OSA) has detrimental effects on the health and quality of life of suffers. Recent literature has shown that females may be particularly susceptible to adverse the quality of life effects, and that female obstructive sleep apnea manifests differently than male obstructive sleep apnea. A new AutoSetting Positive Airway Pressure (PAP) device has been designed specifically to treat female OSA. In this Cohort study, female patients who are newly diagnosed with OSA will be asked to complete various questionnaires relating to their quality of life. Patients will then use the AutoSet for Her for three months. At the completion of the three months the questionnaires will be repeated. Before treatment and after treatment quality of life will be compared to determine if treating female specific OSA in these patients improves quality of life.


Eligibility criteria: Inclusion Criteria:

* Females aged ≥ 18 years
* Diagnostic PG/ PSG showing at least moderate OSA (AHI ≥ 15)
* Indication for PAP
* Participants willing and able to give written informed consent
* Ability to tolerate PAP therapy

Exclusion Criteria:

* Participants currently using CPAP or who have previous experience with CPAP
* Participants currently using supplemental oxygen
* Participants who are pregnant or planning to become pregnant in the next 3 months

Primary outcomes:
measure: Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: 3 months
Secondary outcomes:
measure: Sleep Changes Assessed Through Polysomnography
timeFrame: 3 months
Other outcomes:
Locations:
city: Blaubeuren
country: Germany
facility: Sleep and Ventilation Center
state: Ulm
city: Berlin
country: Germany
facility: Advanced Sleep Research GmbH
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme.
Study officials:
affiliation: Hospital Universitario de Valme
name: Francisco Campos-Rodríguez, Prof
role: PRINCIPAL_INVESTIGATOR
References: