louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01265420: Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
Official title: The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dupuytren's Contracture
Keywords: Dupuytren
Dupuytren's Disease
Lead sponsor: Indiana Hand to Shoulder Center
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that clostridial collagenase will have safety not significantly different to that demonstrated in Phase III clinical trials, and will be effective in significantly reducing the degree of thumb contracture.


Eligibility criteria: Inclusion Criteria:

* Adult subjects (\> 18 years) of either gender with an MP and/or IP joint contracture and a palpable cord of \> 20 degrees of the thumb
* First web space contracture with a palpable cord due to Dupuytren's contracture

Exclusion Criteria:

* Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture of the same thumb.
* Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).
* Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.
* Any subject with known allergy to Xiaflex (Clostridial collagenase).
* Pregnant or nursing female
* Any subject who cannot conform to the study visit schedule

Primary outcomes:
measure: Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)
timeFrame: 30 days after last injection
Secondary outcomes:
Other outcomes:
Locations:
city: Indianaplis
country: United States
facility: Indiana Hand to Shoulder Center
state: Indiana
Study officials:
References:
citation: Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866.
Clinical trial NCT02698020: Optimized Oxygen Delivery During General Anesthesia in Newborn Infants
Official title: Oxygen Delivery During General Anesthesia in Newborn Infants: An Open Randomized Controlled Trial of Two Levels of Inspired Oxygen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Toxicity
Oxidative Stress
Keywords: Newborn
Anesthesia
Oxygen
Hyperoxia
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 35
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia.

Detailed description: Eligible infants are infants of less than 44 weeks postconceptional age and without pulmonary disease or demand for supplemental oxygen or assisted ventilation. Control subjects receive current standard of care (anesthesia induction/pre-oxygenation with 80%, maintenance of anesthesia with 40%, and recovery with 80% inspired oxygen). Intervention subjects are maintained on room air throughout the procedure and supplemental oxygen added only if necessary according to the pre-specified oxygen saturation target. Subjects are monitored according to clinical protocols AND with cerebral oximetry (NIRS), transcutaneous measurement of partial pressure of oxygen (pO2), and blood-gas analyses. Blood and urine samples are collected for later analysis of markers for oxidative stress.

Eligibility criteria: 1. Newborn less than 44 weeks postconceptional age
2. No pulmonary disease, no oxygen requirement, or assisted ventilation
3. No genetic syndrome

Primary outcomes:
measure: Transcutaneous and blood-gas pO2
timeFrame: 30 min
Secondary outcomes:
measure: Cerebral Oximetry
timeFrame: 30 min
measure: Atelectasis
timeFrame: 30 min
measure: Isoprostane
timeFrame: 4 h
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Pediatric anesthesia Unit
Study officials:
affiliation: Department of Women's and Children's Health, Uppsala University
name: Johan Agren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00685620: Reinforcement-Based Treatment and Abstinence-Contingent Housing for Drug Abusers
Official title: Reinforcement-Based Treatment and Abstinence-Contingent Housing for Drug Abusers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Drug Abuse
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2008-05-28
Enrollment: 463
Sex: ALL
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: Purpose of the project is to examine the effectiveness of Reinforcement-Based Treatment (RBT) on drug abuse and psychosocial outcomes of iner city opiate abusers who have recently completed a brief detoxification.

Detailed description: Participants are randomized into one of 3-groups: 1) those receiving intensive behavioral therapy plus abstinence-contingent housing, 2) those receiving recovery housing alone, and 3) those receiving standard care (referrals to community providers). For the two groups receiving recovery housing, rent payment is provided for a period of 3 months, as long as the participant remains drug-free.

Eligibility criteria: Inclusion Criteria:

* opiate dependent agree to live in recovery housing

Exclusion Criteria:

* acute psychiatric disorder pregnant over 65

Primary outcomes:
measure: Drug abstinence at follow-up
timeFrame: 1, 3 and 6 months
Secondary outcomes:
measure: Rates of employment
timeFrame: 1, 3, and 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Maxine Stitzer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tuten M, DeFulio A, Jones HE, Stitzer M. Abstinence-contingent recovery housing and reinforcement-based treatment following opioid detoxification. Addiction. 2012 May;107(5):973-82. doi: 10.1111/j.1360-0443.2011.03750.x. Epub 2012 Feb 28.
Clinical trial NCT04978220: Mental and Psychological Problems and Insomnia Disorder of Medical Staff in Hospital With Infected COVID-19 Patients
Official title: Follow-up Study on Mental and Psychological Problems and Insomnia Disorder of Medical Staff in Hospital Where Staff Are Infected With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression Unipolar
Insomnia
Lead sponsor: Peking University Sixth Hospital
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 390
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: There were 644 medical staff on duty in the hospital, of which 360 people participated in the baseline survey, accounting for 55.90%. In the follow-up survey after one year, 199 out of 360 people in the baseline participated, accounting for 55.28% of the baseline.

Brief summary: The objective of this study is to clarify the severity of psychological problems and insomnia and the two's relationship with time of hospital medical staff in hospital where its staff are infected with COVID-19.

Detailed description: A cross-sectional questionnaire survey method was adopted to conduct investigations of medical staff in the researched hospital within one week (baseline) and one year (follow-up) after the discovery of COVID-19 infection cases. 360 subjects were included in the baseline. Then, after one year, 199 subjects who participated in the survey at baseline were included as follow-up. The HADS, ASDS and ISI scales were used to assess the anxiety and depression level, acute stress disorder symptoms, and the severity of insomnia of hospital medical staff; self-made questionnaires was to collect demographic information and descriptive content. Comparing the follow-up medical staff with the baseline, the total scores of ASDS, HADS and ISI, each item scores on the ASDS, HADS and ISI. All of above scales are compared between the quarantined and non-quarantined groups, different quarantined groups (home, hotel, hospital) and non-quarantined groups.

Eligibility criteria: Inclusion Criteria:

* all medical staff of a third-level general hospital in Beijing who discovered a sporadic case of COVID-19 infection; Volunteer to participate in surveys and follow-ups

Exclusion Criteria:

* Incomplete information fills in, which affects the result analysis

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 year
Secondary outcomes:
measure: Acute Stress Disorder Scale (ASDS)
timeFrame: 1 year
Other outcomes:
measure: Insomnia Severity Index (Insomnia Severity Index, ISI)
timeFrame: 1 year
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
Study officials:
affiliation: Peking University Sixth Hospital
name: Xueqin Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04793620: Pertussis Acellular Vaccine Adjuvanted With TQL1055
Official title: A Phase 1, Randomized, Double Blind, Active-Controlled Dose-Escalation Study to Assess the Safety and Immunogenicity of Pertussis Acellular Vaccine Adjuvanted With TQL1055 (PAVA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pertussis
Keywords: vaccine
adjuvant
Lead sponsor: Adjuvance Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential-group dose-escalation study.
Primary purpose: PREVENTION

Brief summary: This is a phase 1 study to evaluate the safety and immunogenicity of the semisynthetic saponin adjuvant TQL1055 administered in combination with an acellular pertussis vaccine.

Detailed description: The recent increase in the incidence of pertussis has prompted the need for improvements to current acellular pertussis vaccines. Use of novel adjuvants is one approach to such improvement. TQL1055 is a rationally designed, semisynthetic analog of the licensed Quillaja saponin (QS)-21. It has been designed to maintain adjuvant activity with improved tolerability and greater ease of manufacture.

This is a Phase 1, randomized, double blind, active-controlled sequential-group study, designed to evaluate the safety, tolerability, and immunogenicity of the combination of TQL1055 and acellular pertussis vaccine. The dose of TQL1055 will increase by group.

Eligibility criteria: Key Inclusion Criteria:

* 18 to 50 years of age
* General good health
* BMI between 17 and 35 kg/m2
* Not of childbearing potential OR using adequate contraception

Key Exclusion Criteria:

* Pregnant or lactating
* Prior medical condition that could adversely affect subject safety
* Clinically significant abnormal laboratory parameter
* Current acute febrile illness
* Contraindication to intramuscular injection
* Contraindication to pertussis vaccination
* Received pertussis vaccine within 3 years

Primary outcomes:
measure: Reactogenicity
timeFrame: 7 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 365 days
measure: Incidence of abnormal laboratory test results
timeFrame: 28 days
measure: Immunogenicity
timeFrame: 28 days
measure: Immunogenicity
timeFrame: 365 days
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Q-Pharm
Study officials:
affiliation: Adjuvance Technologies, Inc.
name: Sean R Bennett, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04551820: Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy
Official title: SPARC: Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystectomy
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent a robotic-assisted cholecystectomy procedure and meet all eligibility criteria will be considered for enrollment.

Brief summary: A multi-center retrospective chart review of short-term outcomes associated with robotic-assisted cholecystectomies performed during regular hours and after-hours.

Detailed description: The study is a retrospective multi-center chart review study of short-term patient outcomes through 30 days after robotic-assisted cholecystectomies performed during regular hours and after-hours. The primary outcomes include the rate of conversion to open, rate of intra-operative adverse events, the rate of post-operative adverse events relating to the cholecystectomy within 30 days, and re-admissions and re-operations relating to the cholecystectomy within 30 days. In addition, operative time, the rate of use of intra-operative imaging, and the hospital length of stay will be collected as secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* Subject between 18 and 80 years of age at the time of surgery.
* Subject underwent a robotic-assisted cholecystectomy during the study time period.

Exclusion Criteria:

* Cholecystectomy was performed as a secondary procedure.

Primary outcomes:
measure: Conversion to open
timeFrame: Intra-operative
measure: Number of adverse events
timeFrame: Intra-operative through the 30 day follow-up period
measure: Re-admissions
timeFrame: After discharge from the hospital post-procedure through the 30 day follow-up period
measure: Re-operations
timeFrame: After the procedure but prior to discharge, through the 30 day follow-up period
Secondary outcomes:
measure: Operative time
timeFrame: Intra-operative
measure: Use of intra-operative imaging
timeFrame: Intra-operative
measure: Length of Hospital Stay (LOS)
timeFrame: From admission to discharge, up to approximately one week
Other outcomes:
Locations:
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT01546220: Water Method in Elder Patients With Unsedated Colonoscopy
Official title: Water Method With Water Exchange Versus Air Insufflation in Elder Patients Undergoing Unsedated Colonoscopy: a Prospective Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Adenoma
Pain
Keywords: colonoscopy
elder patient
water
unsedated
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy.

Older age is independently associated with incomplete colonoscopy, the investigators postulate that these patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in elder patients.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in elder patients. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 70

Exclusion Criteria:

* History of colorectal surgery
* Severe colonic stricture or obstructing tumor
* Patients who cannot give informed consent and those who are hemodynamically unstable

Primary outcomes:
measure: Cecal intubation success rate
timeFrame: up to two years
Secondary outcomes:
measure: Adenoma detection rate
timeFrame: up to two years
measure: Pain Scores on the Visual Analog Scale
timeFrame: up to two years
measure: Cecum intubation time
timeFrame: up to two years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Yanglin Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05840120: Studying the Clinical Research Experiences of Patients With PTSD
Official title: PTSD Clinical Trials Review: Examining Patient Experiences in PTSD Clinical Trials to Identify Influencing Factors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: PTSD
Keywords: PTSD
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-03
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: PTSD patients who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.

Brief summary: Clinical research participation percentages haven't always been fully representative of a given demographic.

The goal is to find out which aspects of a clinical study may make it more difficult for patients to take part or see it through.

The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future PTSD patients during clinical trials.


Eligibility criteria: Inclusion Criteria:

* Must have a medical diagnosis of PTSD that has been confirmed by a physician.
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Pregnant or lactating woman
* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results

Primary outcomes:
measure: Rate of patients who decide to enroll in a PTSD medical study.
timeFrame: 3 months
measure: Number of PTSD patients who remain in clinical trial until 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: Ronconi JM, Shiner B, Watts BV. Inclusion and exclusion criteria in randomized controlled trials of psychotherapy for PTSD. J Psychiatr Pract. 2014 Jan;20(1):25-37. doi: 10.1097/01.pra.0000442936.23457.5b.
citation: Sofuoglu M, Rosenheck R, Petrakis I. Pharmacological treatment of comorbid PTSD and substance use disorder: recent progress. Addict Behav. 2014 Feb;39(2):428-33. doi: 10.1016/j.addbeh.2013.08.014. Epub 2013 Aug 22.
citation: Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.
Clinical trial NCT04948320: Temporomandibular Dysfunction Affects Neck Disability, Headache, Anxiety, And Sleep Quality In Women: A Cross-Sectional Study
Official title: Temporomandibular Dysfunction Affects Neck Disability, Headache, Anxiety, And Sleep Quality In Women: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Disorders
Headache
Neck Disorder
Anxiety
Sleep Disorder
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 212
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: temporomandibular disorder and healthy women

Brief summary: The temporomandibular joint (TMJ), is the only movable joint between the joints in the head and neck system. It is a component of the chewing system and is involved in important functions such as speech, swallowing, taste and breathing. Temporomandibular dysfunction (TMD) is the general name given to various musculoskeletal problems seen in the stomatognathic system, mostly affecting the masticatory muscles and/or TMJ. TMD is the second most common musculoskeletal pain after chronic low back pain. Patients with TMD may also complain of other musculoskeletal problems, craniocervical problems, sleep problems, and anxiety disorders. The aim of this study is to investigate, compare and examine the relationship between neck dysfunction, headache and temporomandibular dysfunction severity, anxiety and sleep quality in female individuals.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 65 years
* Temporomandibular disorders more than 6 months
* Volunteering

Exclusion Criteria:

* Cranio-cervical trauma and temporomandibular operation history
* Infection
* 20-40 points from Fonseca Anamnestic Index 20-40 points

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
Secondary outcomes:
measure: Fonseca Anamnestic Index
timeFrame: Baseline
measure: Numerical Rating Scale
timeFrame: Baseline
measure: Neck Disability Index
timeFrame: Baseline
measure: Headache Impact Test
timeFrame: baseline
measure: General Anxiety Disorder-7 Scale
timeFrame: baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University
Study officials:
References: