louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02049242: Uterine Tourniquet at Open Myomectomy
Official title: Triple Tourniquet vs. Single Tourniquet at Open Myomectomy to Reduce Blood Loss: A Prospective Randomised Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myomectomy
Uterine Leiomyoma
Keywords: Hemorrhage
Leiomyoma
Myofibroma
Uterine Myomectomy
Tourniquet
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: Erzurum Nenehatun Kadın Doğum Hastanesi
First posted: 2014-01-30
Enrollment: 48
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 48
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.

Detailed description: Single tourniquet is applied to uterine isthmus to occlude uterine arteries. Triple tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.

Eligibility criteria: Inclusion Criteria:

* uterine myoma \>12 weeks

Exclusion Criteria:

* Pedunculated myoma, broad ligament myoma
* Hb\<10.5 g /dl

Primary outcomes:
measure: Estimating blood loss at the end of myomectomy
timeFrame: 15 minutes postoperatifly
Secondary outcomes:
measure: The amount of transfusions
timeFrame: 7 Days
measure: A change in hemoglobin
timeFrame: At baseline and 48 hours after surgery
measure: Volume in drains
timeFrame: 7 days
measure: Anti-Mullerian Hormone levels variation
timeFrame: 6 weeks
Other outcomes:
measure: Peri-operative complications
timeFrame: 6 weeks postoperatively
measure: Total operation time
timeFrame: 5 minutes post operatively
measure: Tourniquet time
timeFrame: 5 minutes after tourniquet removed
Locations:
city: Erzurum
country: Turkey
facility: Atatürk Universitesi Araştırma Hastanesi
state: Yakutiye
Study officials:
References:
Clinical trial NCT04689542: Surgical Face Mask Effects in Patients With COVID-19
Official title: Effects of Surgical Face Mask on Submaximal Exercise Test in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Sit-To-Stand test
Surgical Facemask
Dyspnea
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 28
Sex: ALL
Minimum age (years): 18
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 use of personal protective equipment is mandatory for healthcare workers caring patient with COVID-19. To maximise the reduction of virus spread during clinical procedures involving the presence of healthcare workers, it is also recommended to patients to wear surgical facemask. Routine clinical procedures include cardio-pulmonary and strengthening exercises. During these exercises, the wearing of a face mask may be difficult to tolerate by patients, especially since they experience breathing difficulties due to the illness. Therefore, this study aims to verify the effects of the surgical facemask on breathing difficulties and exercise performance during a 1-minute sit to stand test.


Eligibility criteria: Inclusion Criteria:

* Hospitalized for COVID-19
* No need of supplemental oxygen during the procedure

Exclusion Criteria:

* Altered state of consciousness
* Respiratory co-morbidities
* Neurological or orthopedic co-morbidities susceptible to alter the reliability of the sit-to-stand test
* Having required high flow nasal cannula or non-invasive ventilation during the hospital stay

Primary outcomes:
measure: Changes in dyspnea level
timeFrame: Before, immediately after and 2 minutes after the sit-to-stand test
Secondary outcomes:
measure: Changes in respiratory rate
timeFrame: Before, immediately after and 2 minutes after the sit-to-stand test
measure: Changes in heart rate
timeFrame: Before, immediately after and 2 minutes after the sit-to-stand test
measure: Changes in pulsed oxygen saturation (SpO2)
timeFrame: Before, immediately after and 2 minutes after the sit-to-stand test
measure: Number of sit-to-stand repetition
timeFrame: 1 minute
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT02996942: Key Aspects of Medical Practice in Patients With Haemophilia A
Official title: Key Aspects of Medical Practice in Patients With Haemophilia A
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Joint Disease
Keywords: haemophilia, joint disease, quality of life
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from haemophilia centers.

Brief summary: The KAPPa project has the aim to create an international database in which information about clinical features, therapeutic management, burden of illness and costs of severe and moderate haemophilia A patients from different countries and sites is collected. The aim of this project is to analyse the influence of such different characteristics on medical, psychosocial and economic outcomes in patients over the long-term.

Detailed description: 1000 patients with hemophilia A will be enrolled using a webbased registry. Key quality factors that will be registered are : hemophilia joint Health score (HJHS), annual bleed rate, quality of Life (EQ5D), as well as dosing of replacement therapy.

Eligibility criteria: Inclusion Criteria: or forms.

* severe haemophilia A (factor VIII\<1%)
* moderate (factor VIII\<5%)
* signed informed consent

Exclusion Criteria:

* Not fullfilling inclusion criteria

Primary outcomes:
measure: Outcome of factor replacement treatment
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01295242: Natural History of Human Papillomavirus (HPV) Infections in Mid-Adult Women (WHIM)
Official title: Natural History of HPV Infections in Mid-Adult Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Papillomavirus Infections
Keywords: HPV
Cervical Cancer
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 409
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 to 50 year old women affilitated with Univeristy of Washington (student, staff, faculty)

Brief summary: The purpose of this study is to determine rates of oral and genital human papillomavirus (HPV) infections, and look at risk factors for HPV infection in healthy mid-adult women.

Detailed description: The investigators propose a longitudinal study of 500 women in order to determine rates and risk factors for HPV infections in 30-50 year old women. Participants will be followed for 6 months and will be asked to complete online questionnaires on their health, sexual behavior, HPV vaccinations, and cervical cancer screening. The investigators will ask participants to self-collect monthly vaginal swab samples and self-collect 2 oral swab samples. Women will also be asked to provide 2 blood samples. All swab samples will be tested for type-specific HPV deoxyribonucleic acid (DNA) using a polymerase chain reaction (PCR)-based assay, blood samples will be tested for HPV antibodies.

Eligibility criteria: Inclusion Criteria:

* affiliated with the University of Washington (student, staff, faculty)
* willing to self-collect vaginal samples at home for HPV testing
* able to provide informed consent

Exclusion Criteria:

* pregnant
* have had hysterectomy
* serious medical condition which prevents completion of activities of daily living

Primary outcomes:
measure: Presence of type-specific HPV DNA in self-collected oral and vaginal swab samples
timeFrame: once a month for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Rachel L Winer, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04495842: The Effect of Aromatherapy on COVID-19-induced Anxiety
Official title: The Effect of Aromatherapy on COVID-19-induced Anxiety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Covid19
Anxiety
Keywords: aromatherapy
essential oils
environmental health
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 100
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: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the potential for a non-invasive sensory based intervention to reduce the stress associated with a COVID-19 diagnosis.

Detailed description: After being informed about the study, participants who provide consent will be randomized to one of two groups. Participants will receive one of two aromas to inhale with one being active and the other a control comparison.

Eligibility criteria: Inclusion Criteria:

* Otherwise healthy
* Documented COVID-19 exposure, suspected infection, or diagnosed infection
* Has been tested for or diagnosed with COVID-19
* adults age 18-65 living in the US
* understands and agrees to comply with study procedures
* provides informed consent

Exclusion Criteria:

* Smoker in household
* Pregnant or may become pregnant
* Difficulty breathing
* Pain or pressure in the chest
* Confusion
* Hospitalization
* Asthma, COPD, or other respiratory condition
* demonstrated inability to comply with study procedures
* has participated in an interventional clinical study within 31 days prior to enrollment

Primary outcomes:
measure: Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes
timeFrame: Baseline and at 15 minutes
measure: Change from baseline in mood state on the Abbreviated Profile of Mood States (POMS)
timeFrame: Baseline and at 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Franklin Health Research Center
state: Tennessee
Study officials:
affiliation: Nutraceuticals Research Institute
name: Jessie Hawkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02237742: A Study To Understand How The Body Reacts To A Low Dose Of PF-06427878 When Given In A Vein To Healthy, Adult, Males
Official title: A Phase 1, Non-Randomized, Open-Label, Single-Dose, Single Period Study With Non-Pharmacologically Active Dose Of Pf-06427878 To Characterize Pharmacokinetics Following Intravenous Administration In Healthy, Adult, Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-09-11
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30 minutes to healthy, adult, males.


Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects between 18-55 years of age
2. BMI of 17.5-30.5 kg/m2

Exclusion Criteria:

1. History of drug or alcohol abuse within 2 years of screening
2. Subjects without suitable veins for multiple venipuncture/cannulation

Primary outcomes:
measure: Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
measure: Area under the Plasma Concentration-Time Curve From Time Zero extrapolated to Infinite Time (AUCinf)
timeFrame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
measure: Plasma Terminal Elimination Half Life (t1/2)
timeFrame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
measure: Plasma Systemic Clearance (CL)
timeFrame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
measure: Plasma Volume of Distribution at Steady State (Vss)
timeFrame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Secondary outcomes:
measure: Amount of unchanged drug excreted in urine from time 0 to 12.5 hours (Ae12.5)
timeFrame: Day 1 Hr 0 to 12.5
measure: Percent of dose excreted in urine as unchanged drug from time zero to 12.5 hours (Ae12.5%)
timeFrame: Day 1 Hr 0 to 12.5
measure: Renal clearance (CLr)
timeFrame: Day 1 Hr 0 to 12.5
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Clinical Ltd
state: Nottingham
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002042: A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia
Official title: A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Cytopenias
Keywords: Recombinant Proteins
Erythropoietin
Acquired Immunodeficiency Syndrome
Anemia
AIDS-Related Complex
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or advanced AIDS related complex (ARC) and anemia secondary to their disease.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of any primary hematologic disease.
* HIV disease related dementia.
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.
* Anemia attributable to factors other than HIV disease or zidovudine (AZT) therapy.
* Acute opportunistic infection.
* History of seizures.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease.

Concurrent Medication:

Excluded:

* Zidovudine (AZT) therapy during the double-blind phase of study.

Patients with the following are excluded:

* History of any primary hematologic disease.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease.
* HIV disease related dementia.
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.

Prior Medication:

Excluded within 30 days of study entry:

* Experimental drug or experimental device.
* Cytotoxic chemotherapy.
* Excluded within 2 months of study entry:
* Androgen therapy.
* Zidovudine (AZT) therapy and during the double-blind phase.

Clinical diagnosis with AIDS or AIDS related complex (ARC) and related anemia.

* Clinical diagnosis of AIDS or ARC.
* Clinically stable for 1 month preceding study entry.
* Patients should preferably be transfusion dependent.

Substance abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Raritan
country: United States
facility: Ortho Pharmaceutical Corp
state: New Jersey
Study officials:
References:
Clinical trial NCT03974542: Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing
Official title: Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing in Population Colorectal Cancer Screening Programme- a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer Screening
Lead sponsor: Centre for Health Protection, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2019-06-05
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: To conduct a randomised control trial to test the effectiveness of telephone outreach programme to improve the uptake rate of repeat fecal occult blood test in colorectal cancer screening programme.

Detailed description: The colorectal cancer screening programme(CRCSP) adopts a two-tier approach, offering faecal occult blood test (FOBT) by FIT as first line screening followed by colonoscopy examination for cases with positive FIT result. Under the CRCSP, participants with negative or uninformative FIT result in the first round should be re-screened after 24 months.

The objective is to conduct a randomised control trial to test the effectiveness of telephone outreach programme to improve the uptake rate of repeat fecal occult blood test in CRCSP.

Eligibility criteria: Inclusion Criteria:

* Participants of CRCSP born between 1949 and 1951 with negative or uninformative FIT result in the first screening round who are due for second rescreening round for at least 4 months but did not turn up for rescreening

Exclusion Criteria:

* Nil

Primary outcomes:
measure: rescreening of CRC
timeFrame: 2 months
measure: rescreening of CRC
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06935942: The Associations of Plasminogen Activator Inhibitor-1 Gene Polymorphisms With Crohn's Disease in Chinese Patients
Official title: The Associations of Plasminogen Activator Inhibitor-1 Gene Polymorphisms With Crohn's Disease in Chinese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 906
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: There was no statistically significant difference in the gender ratio, average age, and proportion of smokers between CD group and normal control group. All study subjects are from the Zhejiang Han population who are not related by blood.

Brief summary: From January 2020 to January 2025, Crohn's disease (CD) patients and gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. The aim of this research is to explore the associations of plasminogen activator inhibitor-1 (PAI-1) gene polymorphisms with the risk and clinicopathological characteristics of CD, and to analyze the effects of PAI-1 gene variantions on the clinical response of ustekinumab (UST) treatment in CD patients at week 8.

Detailed description: From January 2020 to January 2025, a total of 311 CD patients and 495 gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University.The genotypes of PAI-1 were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Unconditional logistic regression was employed to analyze the distribution of PAI-1 gene polymorphisms between CD group and normal control group, as well as their influences on the clinicopathological characteristics of CD patients. Multi-model logistic regression was used to explore the effect of PAI-1 gene variation on the clinical response of CD patients in the treatment of UST at week 8.

Eligibility criteria: Inclusion Criteria:

diagnosed CD based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results

Exclusion Criteria:

rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.

Primary outcomes:
measure: the genotypes of PAI-1
timeFrame: Baseline
Secondary outcomes:
measure: clinical response of ustekinumab (UST) treatment
timeFrame: week 8
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: the Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT05581342: Added Value of OCT for Diagnosing Recurrent BCC After Non-invasive Treatment
Official title: Optical Coherence Tomography for Diagnosing Recurrent Basal Cell Carcinoma After Non-invasive Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basal Cell Carcinoma
Keywords: Optical coherence tomography
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients who were non-invasively treated for superficial basal cell carcinoma within five years post-treatment could be included. If CDE or OCT rose suspicion for recurrence a biopsy was obtained. When no suspicion for recurrence was raised; patients were asked to voluntarily undergo a control biopsy to verify absence of recurrence.
Primary purpose: DIAGNOSTIC

Brief summary: Superficial basal cell carcinoma (sBCC) can be treated non-invasively, but follow-up is necessary because lesions can reoccur. This study aims to evaluate the additional value of optical coherence tomography (OCT) for the detection of recurrent BCC lesions, that may remain unrecognized by clinical and dermoscopic examination (CDE). This study compared the diagnostic accuracy of CDE and CDE combined with OCT for detection of recurrent basal cell carcinoma (BCC) after non-invasive treatment of sBCC.


Eligibility criteria: Inclusion Criteria:

* Non-invasively treated sBCC patients
* 18+ years of age

Exclusion Criteria:

* Unable to sign informed consent

Primary outcomes:
measure: The added value of OCT for the detection of recurrent BCC
timeFrame: 1- 56 months post treatment
Secondary outcomes:
measure: The number of false-positive OCT test results
timeFrame: 1- 56 months post treatment
measure: Subtyping recurrent BCC by OCT
timeFrame: 1- 56 months post treatment
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
state: Limbrug
Study officials:
References: