louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04655144: Dexamethasone for Post Uterine Artery Embolization Pain
Official title: Intra-Arterial Dexamethasone for the Alleviation of Pain and Postembolization Syndrome Following Uterine Artery Embolization
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Leiomyoma
Keywords: Fibroids
Leiomyoma
post-embolization pain
dexamethasone
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 82
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to investigate if administration steroids (anti-inflammatory medication) via the uterine arteries during uterine fibroid embolization (A non surgical procedure for treating uterine fibroids by blocking their blood supply) can help reduce the pain, nausea, vomiting, and general feeling of weakness following the procedure.


Eligibility criteria: Inclusion Criteria:

* Women who meet criteria to undergo uterine fibroid embolization for symptomatic fibroids.

Exclusion Criteria:

* Currently pregnant or actively attempting to conceive
* Those deemed mentally impaired to make their own medical decisions
* Previous documented allergy to dexamethasone
* Those currently taking daily steroids for any reason
* Those with diabetes or deemed to be pre-diabetic
* Those with contraindications for angiography
* Prisoners

Primary outcomes:
measure: Pain scores using the VAS Questionnaire
timeFrame: Day 7
Secondary outcomes:
measure: Severity of post-embolization syndrome symptoms
timeFrame: Day 7
measure: Change in uterine fibroid volume
timeFrame: Baseline, 3 months
measure: Change in symptoms
timeFrame: Baseline, 3 months
measure: Change in quality of life
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
Study officials:
affiliation: University of Miami
name: Prasoon Mohan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03086044: Transplanting Hepatitis C Positive Organs
Official title: Transplanting Organs From Hepatitis C Positive Donors to Hepatitis C Uninfected Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis C
Awaiting Organ Transplant
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, pilot safety and efficacy trial for adults who are active on the heart, lung, or kidney transplantation lists and are eligible to receive an organ from an increased risk donor who has evidence of active or prior hepatitis C infection (HCV).

Detailed description: This is an open label pilot study transplanting organs from Hepatitis C positive donors into HCV uninfected recipients at Brigham and Women's Hospital. Heart, lung and kidney transplant participants will be stratified into two different study arms depending on whether the donor of the organ was HCV nucleic acid amplifications technology (NAT) positive or negative. In the NAT positive arm, the recipients will receive a course of direct acting antivirals (DAA) to begin on the day of transplant. If the donor was HCV antibody (Ab) positive and NAT negative, the recipients will receive close monitoring with serial HCV viral loads (VL) and will only begin treatment with DAA if they develop HCV viremia.

Eligibility criteria: Inclusion Criteria:

* Men and women who are age ≥ 18 years
* Active on either the cardiac, lung, or kidney transplant waiting list
* Willing and able to provide written informed consent to receive organs from an increased risk donor with a known transmissible infection

Exclusion Criteria:

* Hepatitis B NAT or viral load positive
* Evidence of cirrhosis or clinically significant liver disease

Primary outcomes:
measure: Graft survival
timeFrame: 6 months post-transplant
measure: HCV status of the transplant recipient
timeFrame: 6 months post-transplant
Secondary outcomes:
measure: Treatment related adverse events
timeFrame: 6 months post-transplant
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Lindsey Baden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woolley AE, Singh SK, Goldberg HJ, Mallidi HR, Givertz MM, Mehra MR, Coppolino A, Kusztos AE, Johnson ME, Chen K, Haddad EA, Fanikos J, Harrington DP, Camp PC, Baden LR; DONATE HCV Trial Team. Heart and Lung Transplants from HCV-Infected Donors to Uninfected Recipients. N Engl J Med. 2019 Apr 25;380(17):1606-1617. doi: 10.1056/NEJMoa1812406. Epub 2019 Apr 3.
Clinical trial NCT00151944: Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
Official title: A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colitis, Ulcerative
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.


Eligibility criteria: Inclusion Criteria:

* Subjects must have completed all assessments of SPD476-301 or SPD476-302 End of Study/Early Withdrawal Visit
* Subjects who did not achieve remission at the End of Study/Early Withdrawal Visits in Study 301 or 302 will be eligible to enter the Acute Phase; subjects who did achieve remission at the End of Study Visits in Study 301 or 302 will be eligible to enter directly into the Maintenance Phase
* Women of childbearing potential must use an acceptable contraceptive method while on study treatment

Exclusion Criteria:

* Subjects who withdrew from Study 301 or 302 before Study Visit 3, or who withdrew due to a possible or probably related severe adverse event or serious adverse event are not eligible to enter this study

Primary outcomes:
measure: Treatment emergent adverse events
timeFrame: Throughout the study period of approximately 2 year, 4 months
Secondary outcomes:
measure: Time to relapse
timeFrame: Up to 12-14 months
measure: Participant compliance
timeFrame: Up to 12-14 months
measure: Number of participants in remission
timeFrame: 12 months
measure: Ulcerative colitis disease activity index (UC-DAI) score
timeFrame: Baseline, Month 2, and Month 12
measure: Patient questionnaire
timeFrame: Month 6, and Month 12
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, Barrett K, Joseph R. Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. Gut. 2008 Jul;57(7):893-902. doi: 10.1136/gut.2007.138248. Epub 2008 Feb 13.
citation: Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, Barrett K, Joseph R. Effect of extended MMX mesalamine therapy for acute, mild-to-moderate ulcerative colitis. Inflamm Bowel Dis. 2009 Jan;15(1):1-8. doi: 10.1002/ibd.20580.
Clinical trial NCT06220344: Honey Dressing - A Preventive Procedure for Post-Surgical Site Infection.
Official title: Honey Dressing - A Preventive Procedure for Post-Surgical Site Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Wound Infection
Wound Dehiscence
Wound Bleeding
Wound Surgical
Lead sponsor: HITEC-Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare the wound healing in the participants who underwent the clean surgical procedure, by applying honey dressing and common Iodine solution dressing, participants will have no other co-morbidities like Diabetes, Anemia, etc. which can make the results biased. The main questions it aims to answer are:

* Do the iodine solutions are enough to counter the infections caused by resistant strains of bacteria?
* What is the efficacy and efficiency of honey dressing in wound care?

Participants will be tasked to

* Ensure strict follow-up in the hospital dressing room
* Half of the participants will apply common iodine solution dressing and the other half will be applied honey dressing.

Researchers will compare Iodine dressing (Control group) with Honey dressing (Experimental group) to see if Honey dressing is better in the prevention of post-surgery wound infection and if it is cost-efficient and its efficacy.


Eligibility criteria: Inclusion Criteria:

Patients with sterile/clean post-surgical wounds are admitted in general surgery, neurosurgery, orthopedic, and gynecology wards and require follow-up dressings.

Exclusion Criteria:

1. Patients with:

   * Anemia
   * BMI\>30
   * Local Infection in wound area.
   * Venous leg ulcers
   * Diabetes
   * Immunocompromised (Oncological patients)
2. Patient under negative pressure therapy

Primary outcomes:
measure: Signs of Wound Infection
timeFrame: 3rd day, 7th day, 15th day.
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Heavy Industry Taxila Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT03268044: Surgical Admission at the Weekend and 30-day Mortality in Ontario, Canada: a Matched Cohort Study
Official title: The Association Between Weekend Admission and Perioperative Adverse Outcomes for Adults Undergoing Surgery: A Matched Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 340000
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: Any hospital admission in Ontario, Canada, between 2005 and 2015 for noncardiac surgery.

Brief summary: Surgery is performed at the weekend for risk to life or limb, when mandated by clinical guidelines, or depending on resource availability. Weekend healthcare interventions have been associated with increased mortality and adverse clinical outcomes in the majority of the literature examining the weekend effect, but these findings are not consistent. Results from recent observational studies argue against a true weekend effect. Higher rates of adverse outcomes associated with hospital activity at weekends do not appear to be due to altered medical staffing as commonly hypothesized, but are thought to be in part a result of data artefact and confounding by severity or indication. For this study, we hypothesized that patients who are admitted to hospital at the weekend and require surgery have an increased risk of death compared with patients who are admitted and undergo surgery on weekdays. The primary aim was to examine whether patients who underwent surgery and were admitted at the weekend had an increased risk of 30 day all-cause mortality compared with patients who were admitted and underwent surgery on weekdays; secondary aim was to examine whether the timing of surgery (i.e., surgery on the same weekend or surgery on a subsequent weekday) for patients admitted at the weekend is associated with increased risk of 30 day all-cause mortality.


Eligibility criteria: Inclusion Criteria:

* any hospital admission associated with an eligible surgical procedure in the Ontario discharge abstract database
* between 2005 and 2015

Exclusion Criteria:

* cardiothoracic or cardiology therapeutic procedures
* non-surgical therapeutic interventions (e.g. dialysis)
* obstetric procedures.

Primary outcomes:
measure: 30 day all cause mortality
timeFrame: 30 days from surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT02936544: Sun Protection Factor Assay (SPF Assay 204/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-10-18
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT00610844: Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors
Official title: Evaluation of Effectiveness of Preoperative Percutaneous Radiofrequency Ablation of Primary and Secondary Lung Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lung Metastasis
Keywords: lung cancer
lung metastasis
radiofrequency ablation
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors.

Detailed description: Thermal ablation therapy is an increasingly performed technique in the local tumor treatment. Among these techniques, image-guided radiofrequency (RF) ablation attained widespread consideration in the therapy of liver tumors and osteoid osteoma. Promising results of hepatic RF ablation raised expectations to utilize the advantages of image-guided ablation therapy for the treatment of pulmonary malignancies. The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors. Computed tomography-guided RF ablation is performed in local or general anesthesia, followed by surgical resection three days later. An analysis of complete RF ablation and a characterization of tissue response is performed by hematoxylin and eosin staining, immunostaining, and electron microscopy. Adverse effects and complications are recorded.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent for radiofrequency ablation and surgery
* Maximum of 3 lung tumors
* Maximum tumor size 5 cm
* Must be able to receive standard surgery

Exclusion Criteria:

* Pathological coagulation tests
* Pregnant or breast feeding
* Maximum tumor size more than 5 cm
* Bilateral secondary lung cancer with more than 3 tumors
* Inoperable patient

Primary outcomes:
measure: rate of incomplete treated tumors
timeFrame: 3 days
Secondary outcomes:
measure: pathologic tissue changes, rate of major and minor complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department of Diagnostic Radiology
state: BW
Study officials:
affiliation: Department of Diagnostic Radiology, University of Tübingen
name: Philippe L Pereira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of thoracic surgery, University of Tübingen
name: Hermann Aebert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06879444: "Core Stabilization Strenght and Pelvic Floor Functions in Primary Sjogren's"
Official title: "Investigation of 'Core' Stabilization Strength and Pelvic Floor Functions in Individuals with Primary Sjogren: a Controlled Study"
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Sjogren Syndrome
Healthy Volunteers
Keywords: pelvic floor
core stabilization
Sjogren syndrome
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Sjogren syndrome group and control group

Brief summary: This study aims to explain the comparison of core stabilization strength and pelvic floor functions between individuals diagnosed with Sjogren syndrome and a healthy control group.

(Sjogren syndrome group n=27; control group n=27)


Eligibility criteria: Inclusion Criteria:

Sjogren syndrome group:

* Diagnosed by a rheumatologist
* Being 18 years of age or older,
* Agreeing to participate in the study

Control group:

-Being 18 years of age or older,

Exclusion Criteria:

Sjogren syndrome group and control group:

* Presence of neurological disease
* Presence of any orthopedic problem that would affect functionality
* Presence of a history of orthopedic surgery

Primary outcomes:
measure: Pelvic Floor Distress Inventory-20 (PTDE-20)
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Sexual Life Quality Scale- Women (CYKÖ-K)
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Incontinence Impact Questionnaire (IIQ-7) (IES)
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: The McGill trunk muscle endurance test
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Secondary outcomes:
measure: Health assessment questionnaire (HAQ)
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Cognitive Exercise Therapy Approach (BETY)
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale Üniversitesi
Study officials:
References:
Clinical trial NCT04334044: Treatment of SARS Caused by COVID-19 With Ruxolitinib
Official title: Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Severe Acute Respiratory Syndrome Coronavirus 2
Lead sponsor: Grupo Cooperativo de Hemopatías Malignas
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Use of ruxolitinib on patients with respiratory distress and pneumonia changes on chest computed tomography
Primary purpose: TREATMENT

Brief summary: In December 2019, a new virus emerged in Wuhan, China rapidly becoming a pandemic with registered cases above 800,000 around the world. The virus is now known as SARS-CoV2 calling its disease coronavirus-19 or COVID-19. The mortality of the virus has been reported around 2-10% and its causes because of the proinflammatory immune response generated on the host. The cytokines involved in the immune response to COVID-19 are IL-1, IL-2, IL4, IL-6, IL-10, IL-12, IL-13, IL-17, GCSF, MCSF, IP-10, MCP-1, MIP-1α, HGF, IFN-γ y TNF-α.

Ruxolitinib is an inhibitor of JAK 1/2 which is responsable for multiple cellular signals including the proinflammatory IL-6. Ruxolitinib works as and immunomodulator decreasing the cytotoxic T lymphocytes and increasing the Treg cells.

This study is intended to stop the disregulated immune response caused by COVID-19 that generates the pneumonia and subsequent severe acute respiratory syndrome.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed COVID-19 with confirmatory test
* Increase in work of breathing or presence of dyspnea
* Presence of lung changes associated with COVID pneumonia by chest imaging
* Informed consent

Exclusion Criteria:

* Pregnancy or breastfeeding
* Thrombocytopenia below 20,000 cells/mm3
* Neutropenia below 500 cels/mm3
* Known and active infection of HIV, Hepatitis C, Hepatitis B, Herpes Zoster or Mycobacterium Tuberculosis

Primary outcomes:
measure: Recovery of Pneumonia
timeFrame: 14 days
Secondary outcomes:
measure: Response of C-reactive protein
timeFrame: 14 days
measure: Response of Ferritin
timeFrame: 14 days
measure: Response of D-dimer
timeFrame: 14 days
measure: Rate of ICU admission
timeFrame: 14 days
measure: Rate of mechanical ventilation
timeFrame: 14 days
measure: Overall Survival
timeFrame: 1 month
measure: Toxicity Rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Huixquilucan
country: Mexico
facility: Grupo Cooperativo de Hemopatías Malignas
state: Estado De México
Study officials:
References: