louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02901405: Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery
Official title: Negative Pressure Dressings Versus Non-negative Pressure Dressing for Wound Care Following Soft Tissue Sarcoma Excision
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sarcoma
Wound Infection
Keywords: sarcoma
infection
negative pressure
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 17
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomised controlled trial aims to evaluate the difference in surgical site infection following excision of soft tissue sarcomas. The intervention is a negative wound pressure therapy dressing for 120 hours, the control is standard absorbent dressings

Detailed description: Hypothesis: The application of a negative pressure wound therapy (NPWT) dressing will reduce rates of wound breakdown in patients with resection of soft tissue sarcomas which are primarily closed.

Patients will be randomised into either NPWT or standard absorbent dressings with primary outcome measure of surgical site infection according to the Health Protection Agency guidance. Secondary outcomes are; time to wound dryness, delayed discharge from hospital, adverse events, cost estimation

Eligibility criteria: Inclusion Criteria:

* Adults undergoing primary soft tissue sarcoma excision which is primarily closed.

Exclusion Criteria:

* Unable to consent
* Children
* Post radiation sarcomas or sarcoma in presence of active infection
* Multiple metastatic disease
* Presence of Endoprosthesis

Primary outcomes:
measure: Surgical Site Infection (proportion)
timeFrame: 30 days
Secondary outcomes:
measure: Time to wound dryness (nominal scale)
timeFrame: 30 days
measure: Delay to discharge form hospital (nominal scale)
timeFrame: 30 days
measure: Adverse events (count)
timeFrame: 30 days
measure: Cost analysis (comparative nominal scale in £)
timeFrame: 30 days
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
state: Scotland
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Sanjay Gupta, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04753905: Surgical Guide for Thoracic Pedicle Screw Instrumentation in Scoliosis Correction Surgery
Official title: Surgical Guide for Thoracic Pedicle Screw Instrumentation in Scoliosis Correction Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scoliosis
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2021-02-15
Enrollment: 1
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with scoliosis and the cobb angle exceeds over 50 degree.

Brief summary: Surgical Guide for Thoracic Pedicle Screw Instrumentation in Scoliosis Correction Surgery


Eligibility criteria: Inclusion Criteria:

* Scoliosis patients

Exclusion Criteria:

* None

Primary outcomes:
measure: The accuracy of surgical guile
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Teipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT01555905: Respiratory Muscle Strength in Patients With NMD
Official title: Respiratory Muscle Strength and Function in Patients With Neuromuscular Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neuromuscular Disease
Keywords: Respiratory Muscle Strength
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 17
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if inspiratory muscle strength training (IMST) will impact maximal inspiratory pressure and pulmonary function in patients with neuromuscular disease.

Detailed description: Subjects undergo a 12-week period of inspiratory muscle strength training. Respiratory strength is assessed before and after the training period.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of neuromuscular disease
* Clinical evidence of impaired pulmonary function

Exclusion Criteria:

* Above or below age range
* No clinical evidence of impaired pulmonary function
* No diagnosis of a neuromusuclar disease
* Presence of an acute illness at time of study
* Participating in other research studies involving investigational drugs
* Diagnosis of a primary pulmonary disease
* Use of tobacco products

Primary outcomes:
measure: Maximal Inspiratory Pressure
timeFrame: Baseline (pre-IMST) and 3 months (post-IMST)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Barbara K Smith, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04080505: Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy?
Official title: Does the Use of Pre-operative SSKI Actually Reduce Vascularity and Improve Surgical Outcomes for Total Thyroidectomy in Graves' Disease?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Graves Disease
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants complete a baseline neck ultrasound no less than 7 days prior to surgery, to obtain vascular flow imaging. Participants are then randomized to receive 7 days of pre-operative SSKI or not receive any drug. In the practice at Columbia, all patients with Graves' disease receive SSKI preoperatively, though this is not standard practice across the country, thus the 'no drug' group is experimental for research.

All participants complete a second ultrasound on the operating table before surgery, to assess for change in vascularity (experimental, as not all patients receive intra-operative ultrasounds before surgery). Both ultrasounds are performed by the surgeon.
Primary purpose: OTHER

Brief summary: The purpose of this research is to find out if SSKI (Potassium Iodide) reduces vascularity (the number and concentration of blood vessels) and improves how well patients do after surgery for removal of their whole thyroid gland in Graves' disease (an autoimmune disease that is a common cause of hyperthyroidism).

Detailed description: Patients with Graves' disease and goiters tend to have very vascular thyroid glands, which increases operative bleeding risks/rates. Many surgeons treat these patients with preoperative SSKI which is believed to decrease the vascularity, which in turn may decrease bleeding risks. However, there has been no quantitative data published on whether this is a real effect with true clinical benefit, in either animal or human models with SSKI. There have been some studies in Europe studying Lugol's solution, a different formulation of iodine, which show some decreased vascularity using color Doppler or measurements of CD34 cells.

Eligibility criteria: Inclusion Criteria:

* individuals diagnosed with Graves' disease undergoing total thyroidectomy for cure of disease.

Exclusion Criteria:

* no Graves' disease
* \< 18 years old

Primary outcomes:
measure: Change in Vascular Flow From Baseline
timeFrame: From Baseline to Immediately Before Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Jennifer Kuo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00284505: Use of Thalidomide in Patients With Arachnoiditis
Official title: Prospective Study of the Use of Thalidomide in Patients With Arachnoiditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arachnoiditis
Keywords: cytokine
arachnoiditis
neuropathic pain
tumor necrosis factor
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2006-01-31
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study will evaluate whether thalidomide decreases pain in patients with arachnoiditis.

Detailed description: Arachnoiditis, a neuropathic disease caused by inflamation of the arachnoid membrane that surrounds and protects the spinal nerves,can result in a debilitating state that is characterized by numbing and tingling, stinging and burning in the lower back or legs, and possible muscle cramps, twitching and spasms. Current treatments are not always effective in treating the pain associated with arachnoiditis. Recent research has indicated that a group of chemicals called cytokines that are produced by various cells in the body may be responsible for generating the pain response. Medications that effect the release of cytokines or block the action of cytokines may reduce the pain response. Various anti-cytokine medications are now being used to treat painful disease states such as rheumotoid arthritis and Crohn's Disease. In this study the anti-cytokine medication, Thalidomide, is being evaluated for it's effect in treating pain associated with arachnoiditis.

Eligibility criteria: Inclusion Criteria:

* Radiographically confirmed Arachnoiditis
* Involvement of the lower limb(s)

Exclusion Criteria:

* Subjects with baseline peripheral neuropathy to include diabetic neuropathy and other metabolic or toxic neuropathies.

Primary outcomes:
measure: 1. To evaluate the change in pain as measured by the McGill Pain Questionnaire, short form, (SF-MPQ) and consumption of adjuvant opioid medications in three patients with arachnoiditis who receive thalidomide.
measure: 2. To evaluate the change in physical functionality as measured by the Roland-Morris Low Back Pain and Disability Questionnaire in three patients with arachnoiditis who receive thalidomide.
Secondary outcomes:
measure: 1. To measure change in the patient's health status as measured by the SF36 in three patients with arachnoiditis who receive thalidomide.
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University Pain Management Center
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Anthony H Guarino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04315805: Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress
Official title: Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Psychological Distress
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 72
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: SUPPORTIVE_CARE

Brief summary: This study will be a randomized wait list controlled trial studying the efficacy of an Integrative Yoga Therapy for patients with chronic pain and psychological distress. Individualised yoga program will consist of a 8-week guided self-help program.

This study will primarily investigate whether an individually tailored yoga can be beneficial for patients suffering from chronic pain reducing pain, anxiety depression, while improving overall quality of life.


Eligibility criteria: Inclusion Criteria:

* Experienced pain for \> 3 months
* Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress
* Willing to provide informed consent

Exclusion Criteria:

* Severe medical or psychiatric conditions
* Alcohol or substance abuse
* Active suicidality
* Terminal illness

Primary outcomes:
measure: Pain Severity: Visual Analogue Scale
timeFrame: From baseline to 8-week post intervention
measure: Pain Disability
timeFrame: From baseline to 8-week post intervention
measure: Symptoms of depression and anxiety
timeFrame: From baseline to 8-week post intervention
Secondary outcomes:
measure: Insomnia symptoms
timeFrame: From baseline to 8-week post intervention
measure: Mental well-being
timeFrame: From baseline to 8-week post intervention
measure: Self Efficacy: Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale
timeFrame: From baseline to 8-week post intervention
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Karyalaya
state: Leicestershire
Study officials:
affiliation: Aarogyam UK
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Jaydeep Joshi, BAMS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00141505: PK Effects of Bifeprunox & Valproate in Bipolar I
Official title: Placebo-controlled Study on the Pharmacokinetics,Pharmacodynamics, Safety and Tolerability of Concurrent Valproate and Bifeprunox Administration in Subjects With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bipolar I Disorder
Keywords: drug interaction
pharmacokinetics
valproate
bipolar
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-09-01
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: The study is to evaluate the effect of bifeprunox on the pharmacokinetics of valproate in subjects with Bipolar I Disorder after multiple dose administration.


Eligibility criteria: Inclusion Criteria:

* Males or females
* 18-65 years old
* meeting DSM-IV criteria for Bipolar I Disorder, either manic or mixed episodes, with or without psychotic features

Exclusion Criteria:

* subjects who are acutely manic, acutely depressed, psychotic or subjects with a current Axis I primary psychiatric diagnosis other than Bipolar I Disorder based on DSM-IV TR criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Site 1
state: Georgia
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT02220205: Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions
Official title: Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Devices, Intrauterine
Education, Medical
Keywords: IUD
training
simulation
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In order to make them accessible to women, health care providers must be trained to insert them. Physicians, physician assistant, and nurse practitioners often learn how to do so by first learning about IUDs, then practicing on a model that the IUD manufacturer provides.

Educators have recently been using more sophisticated models to teach clinical skills such as surgical procedures. We are investigating whether these models may be more useful in teaching IUD insertion.


Eligibility criteria: Inclusion Criteria:

* First-year residents in obstetrics and gynecology or family medicine, or student in physician assistant or nurse practitioner training programs
* Trainees who have performed \<5 intrauterine device insertions
* Trainees who plan to provide intrauterine devices in their clinical practice

Exclusion Criteria:

* None

Primary outcomes:
measure: Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice
timeFrame: Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice
Secondary outcomes:
measure: Percent Change in Comfort Placing IUDs From Pre- to Post-insertion
timeFrame: Baseline to three months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Siripanth Nippita, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00401505: Rubella Susceptibility in Multiparous Women
Official title: Rubella Susceptibility in Multiparous Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rubella
Vaccine
Keywords: rubella
rubella vaccine
postpartum
immunity
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2006-11-20
Enrollment: 310
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All rubella susceptible women who delivered during the study period.

Brief summary: The purpose of this study is to determine the reasons why multiparous women (women who are pregnant and have been pregnant before) might still be susceptible to rubella.

Detailed description: This study is designed to investigate why multiparous women might still be susceptible to rubella. All pregnant women are checked for rubella immunity, and if they are non-immune, there are standard orders in our hospital to administer the rubella vaccine on the post-partum floor prior to discharge home from the hospital. Despite this, some multiparous women are found to be susceptible (non-immune), and this study will explore the reasons for this.

Eligibility criteria: Inclusion Criteria:

* All rubella susceptible women who delivered during the study period.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Mark H Yudin, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238405: A Controlled Smoking Cessation Trial and Prospective Cohort Study of Tuberculosis (TB) Treatment Outcomes
Official title: A Randomized Controlled Smoking Cessation Trial and Prospective Cohort Study of TB Treatment Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Tuberculosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Global Fund
name: National Tuberculosis Control Program, Pakistan
First posted: 2014-09-12
Enrollment: 350
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary focus of this intervention trial is to understand the effect of quitting smoking on TB treatment outcomes. The investigators will compare a cessation strategy based on guidelines recommended by the World Health Organization (WHO) and the International Union against Tuberculosis and Lung Disease (IUTLD). This is currently not utilized in TB directly observed therapy (DOT) clinics in Pakistan. The investigators study will provide comprehensive data towards understanding the effectiveness of these strategies for TB patients who smoke in Pakistan, and most importantly, on the effect of quitting smoking on TB treatment outcomes. These findings will guide development of effective smoking cessation strategies in a region with high prevalence of TB and increasing tobacco use.


Eligibility criteria: Inclusion Criteria:

* Males, ≥18 years of age
* diagnosed with pulmonary TB
* self-reported current smokers, or smoker within 6 months
* anticipated to be attending the TB treatment clinic for at least 6 months
* be willing to set a quit date within 2 weeks after baseline assessment
* agree to participate

Exclusion Criteria:

* less than 18 years of age
* quit for more than 6 months
* extra-pulmonary TB
* unable/unwilling to provide written consent

Primary outcomes:
measure: Smoking cessation rate
timeFrame: 1-6 months
measure: Smoking cessation rate
timeFrame: 6 months post-TB treatment
Secondary outcomes:
measure: negative TB treatment outcome (death, treatment failure, relapse, required prolongation of TB therapy
timeFrame: 6 months post-TB treatment
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Indus Hospital
Study officials:
affiliation: Johns Hopkins University
name: Jonathan E Golub, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02718105: Maternal and Fetal Compatibility in Assisted Reproductive Technology (ART)-Oocyte Donor Influences Live Birth Rate
Official title: Maternal Killer Cell Immunoglobulin-like Receptors (KIR) and Fetal (Human Leukocyte Antigen) HLA-C Compatibility in ART-oocyte Donor Influences Live Birth Rate a Prospective Controlled Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: KIR HLA-C
ART
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing an assisted reproductive treatment

Brief summary: Has the maternal KIR haplotype an impact in pregnancy, miscarriage and live birth rates per embryo transfer in donor oocytes -ART by paternal and oocyte donor HLA-C?

Detailed description: The combination of maternal KIR haplotype and parental, donors HLA-C, could predict which couple can benefit for the selection of single embryo transfer (SET)/double embryo transfer (DET), or donor selection by HLA-C in ART, in order to increase the live birth rate (LBR)/cycle since HLA-C1/C1 donors are predicted to be safer and C2/C2 males or oocyte donors may be mor "dangerous" as identified by epidemiological studies

Eligibility criteria: Inclusion Criteria:

* BMI between 19 - 27 kg/m2
* Blastocyst embryo transfer previous.
* Normal karyotype, thrombophylic and immunological results.
* Normal clinical history, viral serology, hormonal analysis (TSH, T4, prolactin, estrogen, progesterone), spermiogram, sperm FISH and pelvic ultrasound results.

Exclusion Criteria:

* Pregnancy women.
* Psychiatric disorders.
* Uterus alterations.
* Polycystic ovary syndrome
* Genetic and autoimmune diseases.
* Infectious diseases.
* Corticoid and immunosuppressant treatments previous.

Primary outcomes:
measure: Compatibility maternal fetal KIR HLA-C
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Valenciano de Infertilidad
Study officials:
affiliation: IVI Madrid
name: Juan Antonio Garcia Velasco, PhD
role: PRINCIPAL_INVESTIGATOR
References: