louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06533020: Long-term Outcomes of Complex Conversion Total Hip Arthroplasty
Official title: Long-term Outcomes of Complex Conversion Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthroplasty Complications
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UNC Orthopaedics

Brief summary: The purpose of the research study is to examine the long-term outcomes of complex and conversion total hip arthroplasty procedures. By means of both retrospective (chart review) and prospective (in-person clinic visits) radiographs and validated patient-reported outcome scores including the Hip Disability and Osteoarthritis Outcome Score (HOOS) and the Patient-Reported Outcomes Measurement Information System (PROMIS), the research team aims to collect, analyze, and summarize the outcome data. The outcomes of the follow-up appointment will be analyzed in comparison to previous findings over various intervals to assess changes over time, if data is available.


Eligibility criteria: Inclusion Criteria:

* Having undergone a conversion total hip arthroplasty (THA) more than five years ago or a complex THA more than ten years ago done by a UNC Health-affiliated physician
* Willingness to receive follow-up care from a UNC Health-affiliated physician or provide outcome data regarding this surgical intervention
* Able to speak and read English
* Able to consent to participation

Exclusion Criteria:

* Less than 18 years of age
* Incarcerated status

Primary outcomes:
measure: PROMIS SF v1.1-Pain Interference 8a
timeFrame: once during the 36-month total study duration, preferably during initial recruitment, but open to collection at any time during the study timeframe
measure: PROMIS SF v2.0 - Physical Function 20a
timeFrame: once during the 36-month total study duration, preferably during initial recruitment, but open to collection at any time during the study timeframe
measure: HOOS
timeFrame: once during the 36-month total study duration, preferably during initial recruitment, but open to collection at any time during the study timeframe
measure: Radiographic Findings
timeFrame: once during the 36-month total study duration, preferably during screening for initial recruitment, but open to collection at any time during the study timeframe
Secondary outcomes:
measure: Number of participants with comorbidities
timeFrame: Up to 36-months total study duration
measure: Number of participants with complications
timeFrame: Up to 36 months total study duration
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Alecia Rajesh
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Ishani Deliwala
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00519220: Outcome of Symptoms in Patients Undergoing a Heller Myotomy
Official title: Short and Long Term Outcomes of Heller Myotomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Achalasia
Keywords: achalasia, Heller myotomy
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2007-08-22
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with achalasia who have had laparoscopic Heller myotomies at Tampa General Hospital.

Brief summary: The objective of this study is to review studies and patient symptoms before and after laparoscopic Heller myotomy to assess outcomes following laparoscopic surgery for achalasia.

Detailed description: Patients will answer questionnaires before and after surgery to evaluate their symptoms of achalasia and will also have their charts reviewed for relevant medical information.

Eligibility criteria: Inclusion Criteria:

* Patients with achalasia who have had laparoscopic Heller myotomies for the treatment of achalasia

Exclusion Criteria:

* No patients under the age of 18 will be included

Primary outcomes:
measure: The objective of this study is to review pre-operative and post-operative studies and patient evaluation reports to evaluate patient outcomes following laparoscopic surgery for achalasia
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital/University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Alexander S Rosemurgy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06266520: MNK Therapy in Releasing the Superficial Fascia for Patients With AAS: an Assessor-blinded, Randomised Controlled Trial
Official title: Micro-needle-knife Therapy in Releasing the Superficial Fascia for Patients With Acute Ankle Sprain: an Assessor-blinded, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ankle Sprain
Keywords: acute ankle sprain
micro-needle-knife
superficial fascia
randomized controlled trial
Lead sponsor: Affiliated Dongyang Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this type of randomized controlled trial, employing a blinded evaluator methodology, to verify the clinical efficacy and safety of MNK therapy. This aims to provide a reference for clinical practitioners and AAS patients in their decision-making process.

Participants will randomly allocated into two groups using a random number table method, with forty patients in each group. The experimental group (Group 1) underwent MNK therapy to release the superficial fascia, while the control group (Group 2) received conventional acupuncture treatment.


Eligibility criteria: Inclusion Criteria:

* 16 to 55 years old
* Clear history of trauma within 1 to 7 days
* Presence of localized swelling, pain, bruising, and limping symptoms in the ankle joint
* Pain in the ankle joint upon resistance
* No accompanying fractures
* Diagnosis of acute ankle injury according to the "Diagnostic and Therapeutic Criteria of Traditional Chinese Medicine"
* No prior treatment before participating in this therapy
* Willingness to participate in this study and signing of the informed consent form

Exclusion Criteria:

* Individuals with clear indications for surgery
* Those suffering from gout, rheumatoid arthritis, joint tuberculosis, joint tumors, etc.
* Pregnant or breastfeeding women
* Individuals with serious primary diseases of the cardiovascular, liver, kidney, brain, and hematopoietic systems
* Those with local skin lesions or skin diseases
* Individuals with coagulation dysfunction
* Those with severe fear of needles
* Individuals unwilling to comply with the treatment regimen

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: up to one mont
measure: Kofoed Ankle Score
timeFrame: up to one mont
Secondary outcomes:
Other outcomes:
Locations:
city: Dongyang
country: China
facility: The Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, China
state: Zhejiang
Study officials:
affiliation: The Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, China
name: Xiao-xiao Ma, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06790420: RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study
Official title: RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: Lymphoma
Rituximab
Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-01-24
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes individuals who have a diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma and treated with Rituximab Pfizer and Rituxan

Brief summary: To evaluate the incidence of the outcomes for the safety specifications in patients of Medical Data Vision database in Japan diagnosed with CD20 positive B-cell non- Hodgkin's lymphoma who were treated with Rituximab Pfizer to compare it with outcomes in patients who were treated with Rituxan from 01 January 2020 through 31 December 2024


Eligibility criteria: Inclusion Criteria:

1. Have prescription of Rituximab Pfizer or Rituxan within the enrollment period (Index Date: first prescription date within the enrollment period).
2. Have diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma on the index month or within 6 months before index date
3. Have at least 6 months of Look back period and at least one medical record prior to 7 months before the Index date.
4. Have not prescription of Rituximab product before index date(Comparative Analysis Set only).

Exclusion Criteria:

1. Have any diagnosis of other indications of rituximab products other than CD20 positive B-cell non- Hodgkin's lymphoma before index date .

Primary outcomes:
measure: Incidence of infections which requires procedures, medication or hospitalization
timeFrame: From index date up to 180 days after last dose
Secondary outcomes:
measure: Incidence of 'pancytopenia, leukocytopenia, Neutropenia, agranulocytosis, thrombocytopenia'
timeFrame: From index date up to 180 days after last dose
measure: Incidence of Infusion reactions
timeFrame: From index date up to next day after last dose
measure: Incidence of hepatic function disorder, jaundice
timeFrame: From index date up to 180 days after last dose
measure: Incidence of cardiac disorder
timeFrame: From index date up to 180 days after last dose
measure: Incidence of gastrointestinal perforation/obstruction
timeFrame: From index date up to 180 days after last dose
measure: Incidence of hypotension
timeFrame: From index date up to next day after last dose
measure: Incidence of development of malignant tumor
timeFrame: From index date up to maximum of 5 years (the end of the study period)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01388920: Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Doses of Tesamorelin in Stable Ambulatory COPD Subjects With Muscle Wasting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Muscle wasting
Lead sponsor: Theratechnologies
Sponsor class: INDUSTRY
First posted: 2011-07-07
Enrollment: 3
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A significant proportion of COPD subjects experience muscle wasting, which has been associated with increased morbidity, impaired physical functioning, and a poor quality of life.

Muscle wasting is associated with reduced muscle strength in COPD subjects. In particular, weakness of peripheral muscles has been reported to play an important role in the reduced functional capacity and impaired exercise performance.

The primary objective of this study is to investigate the effect of tesamorelin, in conjunction with exercise training, on lean body mass measured by dual energy x-ray absorptiometry (DXA) scan.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 40-75 years (y) inclusive
* Documented diagnosis of moderate to very severe COPD (GOLD stage 2, 3, or 4)
* Stable COPD (i.e., no exacerbation) for at least 6 weeks prior to screening
* Able to participate in a supervised exercise training program
* Evidence of muscle wasting

Exclusion Criteria

* Participation in a pulmonary rehabilitation program or in any supervised exercise program during the 4 months prior to screening
* More than 4 exacerbations in the year prior to screening
* Life-threatening exacerbation in the year prior to screening
* Requirement for long-term oxygen therapy (\> 12 hours of oxygen per day)
* Critical illness or co-morbid conditions that may interfere with study conduct or endpoint measurements
* Use of agents known to increase lean body mass within 3 months prior to screening
* Hypopituitarism, history of pituitary tumor/surgery, head irradiation, or severe head trauma

Primary outcomes:
measure: Change From Baseline in Lean Body Mass at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Change From Baseline in Exercise Capacity at 6 Months
timeFrame: 6 months
measure: Change From Baseline in Peripheral Muscle Strength at 6 Months
timeFrame: 6 months
measure: Change From Baseline in Patient-reported Outcomes at 6 Months
timeFrame: 6 months
measure: Adverse Events
timeFrame: 6 months
measure: COPD Exacerbations
timeFrame: 6 months
measure: Plasma Glucose
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: Richard Casaburi, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02965820: OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
Official title: Clinical Study of OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Contact lens induced dryness
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-11-17
Enrollment: 122
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate OPTI-FREE® PureMoist® (OFPM) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.


Eligibility criteria: Inclusion Criteria:

* Must sign an informed consent document;
* Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;
* Near spectacle add of +0.50 or greater;
* Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;
* Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
* Currently using a non-Alcon multi-purpose solution to care for lenses (at least 2 months);
* Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study;
* Other protocol-specific inclusion criteria may apply.

Exclusion Criteria:

* Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);
* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Known sensitivity to any ingredients in OFPM;
* Prior refractive surgery;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Pathological dry eye that precludes contact lens wear;
* Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
* Participation in any clinical study within 30 days of Visit 1;
* Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days;
* Other protocol-specific exclusion criteria may apply.

Primary outcomes:
measure: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
timeFrame: Day 30, each product
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, A Novartis Division
name: Clinical Project Manager, CPM
role: STUDY_DIRECTOR
References:
Clinical trial NCT06343220: Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research
Official title: Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Huntington Disease
Keywords: HSG, HD, Observational
Lead sponsor: Huntington Study Group
Sponsor class: NETWORK
Collaborators: name: Roche Products Limited
name: Neurotargeting LLC
First posted: 2024-04-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Must either have HD or be at risk for having HD.

Brief summary: The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted.

Detailed description: The Project AWARE 2.0 Survey will be offered to HD families via HSG's online platform called myHDstory®. The survey will obtain input and knowledge about their feelings, attitudes, and beliefs concerning clinical research and the process by which HD studies are communicated and conducted. Project AWARE 2.0 is intended to provide the HD research community with the insight and tools to help (a) improve prospective research participants' awareness, willingness, and ability to participate in clinical research for HD; and (b) design clinical studies and trials in the future.

Eligibility criteria: Inclusion Criteria:

* Participants must either have HD or be at risk for having HD
* Participants must be 18 years of age or older
* Participants must live in the United States
* Inclusion of participants will not be based on race, gender, or ethnicity.

Exclusion Criteria:

-

Primary outcomes:
measure: Examine awareness
timeFrame: December 2024
measure: Provide the HD research community with the insight.
timeFrame: December 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Huntington Study Group
state: New York
Study officials:
affiliation: HSG
name: Amy Brown, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04791020: Topic Cervical Anesthesia Plus Paracervical Blockade for Pain Control During Endouterine Manual Aspiration
Official title: Topic Cervical Anesthesia Plus Paracervical Blockade vs. Topical Cervical Anesthesia Alone for Pain Control During Endouterine Manual Aspiration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Abortion, Spontaneous
Keywords: Endouterine manual aspiration
Paracervical blockade
Lidocaine gel
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness of lidocaine gel plus paracervical blockade vs. lidocaine gel alone in the management of pain during endouterine manual aspiration.


Eligibility criteria: Inclusion Criteria:

* Need for a endouterine manual aspiration (incomplete abortion or gynecological bleeding).

Exclusion Criteria:

* Allergy to lidocain

Primary outcomes:
measure: Global evaluation of pain
timeFrame: 5 minutes post procedure
Secondary outcomes:
measure: Adverse reaction
timeFrame: 5 minutes post procedure
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas H
Study officials:
References:
Clinical trial NCT00733720: Buprenorphine Naltrexone-P1 A-Cocaine
Official title: Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2008-08-13
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral naltrexone. This study will provide data to support the design of a similar study of the depot formulation of naltrexone and ultimately to study this combination for the treatment of cocaine dependence.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent
* Be male/female between the ages of 18-55
* Be in good physical and mental health as determined by interview and physical exam
* Have a body mass index between 18 and 30, inclusive
* Have no oral cavity pathology that would interfere with sublingual absorption of buprenorphine/naloxone or placebo
* Have negative qualitative urine toxicology screen for opioids, cocaine, benzodiazepines, and barbiturates prior to administration of the first dose of naltrexone
* Be able to comply with protocol requirements
* If female, have a negative pregnancy test and agree to use an acceptable method of birth control from date of consent and until two weeks after the last administration of study drug or placebo

Exclusion Criteria:

* please contact site for more information

Primary outcomes:
measure: Opioid Effects of study drug
timeFrame: daily
Secondary outcomes:
measure: Adverse Events
timeFrame: Daily
Other outcomes:
Locations:
city: San Fransisco
country: United States
facility: Drug Dependence Research Center
state: California
Study officials:
References: