louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02921451: Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
Official title: Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Prolapse
Lead sponsor: Michigan Institution of Women's Health PC
Sponsor class: OTHER
Collaborators: name: Coloplast A/S
First posted: 2016-10-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.

Detailed description: This study is being done to evaluate the performance of the Restorelle system, which uses Smartmesh - an ultra-lightweight mesh for uterine prolapse management. Most patients undergo a hysterectomy i.e. removal of the uterus when they have a prolapse. However, this has often been found to be an unnecessary operation. The investigators are studying the use of the Restorelle mesh system to preserve the uterus when there is a uterine prolapse.

Eligibility criteria: Inclusion Criteria:

1. Subject is female.
2. Subject is at least 18 years of age.
3. Subjects who have already made the decision to proceed with uterine prolapse surgery using Restorelle Mesh.
4. Subject has uterine prolapse defined by Prolapse Quantification System Assessment (POPQ) score of C -2 or greater.
5. Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 2 or higher (i.e. response of "somewhat", "moderately" or "quite a bit").
6. Subject is willing to provide written informed consent.
7. Subject is willing and able to comply with follow-up regimen.

Exclusion Criteria:

1. Subject is pregnant or intends to become pregnant in the future.
2. Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical).
3. Subject has undergone any previous repair for pelvic organ prolapse.
4. Subject has undergone a hysterectomy.
5. Subject lacks competency of the English language.

Primary outcomes:
measure: Number of patients who present with recurrence of uterine prolapse following surgery as assessed by failing to meet success criteria
timeFrame: Within first two years after surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: Advanced Urogynecology of Michigan, P.C.
state: Michigan
Study officials:
affiliation: Advanced Urogynecology of Michigan, P.C.
name: Salil Khandwala
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01947751: Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock
Official title: Comparison Between Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock With Undefined Origin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheter Related Infection
Keywords: Catheter related infection
Central venous catheter
CVC infection
Lead sponsor: Hospital Nossa Senhora da Conceicao
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Central venous catheter(CVC)-related infection is an inherent complication of this device that should be treated promptly. However, there are doubts about the need for the immediate withdrawal of CVC while there is still no confirmation of such infection. The aim of this study is to compare the resolution of CVC-related infection, testing two approaches: catheter´s early exchange, when the possibility of related sepsis is considered, versus the maintenance of the CVC and early antibiotic therapy until the infection is confirmed.

Detailed description: The aim of this study is to compare the strategy of immediate removal of the catheter with a conservative strategy in resolution of infection in patients with sepsis or septic shock without a defined origin. The investigators intend to demonstrate that the conservative strategy can reduce the rate of unnecessary catheter removal, without increasing morbidity.

In the intervention group the investigators will adopt the conservative strategy, changing the CVC after the confirmation of infection related to it or non-improvement of sepsis. The control group is represented by the patients in whom the CVC is removed early.

Eligibility criteria: Inclusion Criteria:

* All patients with 18 years or more, admitted to ICU that had a CVC inserted before or after ICU admission and with infection with undefined origin.

Exclusion Criteria:

* Less than 18 years, severe neutropenia (\<500/mm³), intravascular device (pacemaker, prosthetic valve), unequivocal signs of infection on the site of CVC insertion, patients who were terminally ill defined, bacteremia without a known source, refusal to signing the informed consent.

Primary outcomes:
measure: Infection resolution
timeFrame: 4 weeks
Secondary outcomes:
measure: Clinical variables
timeFrame: 6 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: Rio Grande do Sul
Study officials:
affiliation: Hospital Nossa Senhora da Conceicao
name: Marcio M Boniatti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04976751: Real World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China
Official title: Real World Study on the Application of Appropriate Electrophysiological Technology in the Diagnosis and Treatment of Andrology Diseases in Northwest China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Pelvic Pain
Chronic Prostatitis
Keywords: transcutaneous electric nerve stimulation
andrology
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 274
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To carry out real world research on the application of electrophysiology and other suitable technologies in the prevention and treatment of male diseases in medical institutions at all levels in Northwest China, and establish a database for the prevention and treatment of male diseases in Northwest China, so as to provide a basis for the formulation of guidelines or consensus on the application of electrophysiology for the prevention and treatment of male diseases in China.


Eligibility criteria: Inclusion Criteria:

* Patient meets the diagnostic criteria of National Institutes of Health (NIH)Ⅲ type prostatitis;
* NIH-CPSI score \> 10;
* The symptoms lasted for more than 3 months and failed to respond to drug treatment for more than 1 month;
* Age ≥18 years old and ≤60 years old agrees and signs the informed consent;
* Those who did not receive other similar treatment regimens during treatment.

Exclusion Criteria:

* All kinds of bacterial infection caused by acute or chronic orchitis or epididymitis, acute or chronic prostatitis, lower urinary tract infection;
* Benign prostatic hyperplasia, prostate cancer, neurogenic bladder, urethral malformation or stricture and severe neurosis;
* For patients with local pain as the main manifestation, attention should be paid to the exclusion of other lesions in the lower abdomen, perineum, lsosacral sites, such as ureteral calculi, bladder calculi, inguinal hernia, pubis, varicocele, epididymitis, rectocolic diseases, lsodorsal myofascitis, etc.;
* Complicated with heart, brain, liver and hematopoietic system and other serious primary diseases, local skin infection or skin lesions in the treatment site;
* People who have metal implants in their bodies cannot cooperate, such as patients with mental illness.
* People who are allergic to the treatment of electrical stimulation or allergic to a variety of drugs.

Primary outcomes:
measure: National Institutes of Health-Chronic Prostatitis Symptom Index(NIH-CPSI)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: international prostate symptom score (IPSS)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
References:
Clinical trial NCT00682851: A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
Official title: A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Vaginosis
Urogenital Infection by Trichomonas Vaginalis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 519
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-pregnant women between the ages of 18 and 60, with or without symptoms of vaginitis, were recruited for this study from Magee-Womens Hospital of University of Pittsburgh Medical Center and Allegheny County Health Department.

Brief summary: This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests to diagnose common vaginal infections.

Detailed description: This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests (that take up to 7 days to get results) to diagnose common vaginal infections (Trichomonas and bacterial vaginosis).

Both rapid tests (OSOM and BVBlue) are approved by the Food and Drug Administration (FDA) to be used by healthcare professionals to aid in the diagnosis of these infections. This study is being done to validate (or confirm)the accuracy of these tests. This study may help researchers decide if these tests could be used in remote research settings (in place of the standard office testing) to increase diagnosis and prompt treatment of these vaginal infections.

Eligibility criteria: Inclusion Criteria:

* At least 15 years of age at time of enrollment
* Ability to provide written informed consent

Exclusion Criteria:

* Currently menstruating or bleeding
* Use of an antibiotic to treat bacterial vaginosis or Trichomonas within the past 7 days

Primary outcomes:
measure: Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women
timeFrame: Visit 1
Secondary outcomes:
measure: Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women
timeFrame: Visit 1
measure: Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.
timeFrame: Visit 1
measure: Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.
timeFrame: Visit 1
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sharon L Hillier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04213651: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes mellitus

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to diabetes mellitus

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages
3. Diagnosis of diabetes mellitus based on blood glucose and/or hemoglobin A1C

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02913651: Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia
Official title: Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Narcolepsy
Cataplexy
Keywords: Idiopathic hypersomnia
heart rate variability
parasympathetic activity
autonomic arousal response
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 33
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: Idiopathic hypersomnia patients and no idiopathic hypersomnia patient

Brief summary: Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy affecting the sympathetic function. In this study the investigators analyzed whether altered diurnal and nocturnal cardiovascular control is present in idiopathic hypersomnia. Drug-free patients diagnosed with idiopathic hypersomnia and age-matched controls were included. Clinical data, 24-h polysomnography, heart rate variability and the heart rate response to spontaneous arousal are analyzed.


Eligibility criteria: Inclusion Criteria:

Idiopathic hypersomnia patients

* idiopathic hypersomnia diagnosis
* complaints of excessive daytime sleepiness for \>1 year
* a night-time length \>10 h for 3 weeks before polysomnography as assessed by a sleep diary

Inclusion Criteria:

no idiopathic hypersomnia patients

* no sleep complaints and excessive daytime sleepiness (Epworth sleep questionnaire score \<10

Exclusion Criteria (both):

* Narcolepsy-cataplexy
* sleep irregularities and sleep deprivation symptoms
* lack of neurological or psychiatric diseases
* upper airway resistance syndrome
* periodic limbs movements
* cerebral lesion
* medication or drinks affecting sleep and wake state

Primary outcomes:
measure: High Frequencies (HF)
timeFrame: During the polysomnography (one night)
Secondary outcomes:
measure: Heart rate variability (HRV)
timeFrame: During the polysomnography (one night)
measure: Apnea-Hypopnea Index (AIH)
timeFrame: During the polysomnography (one night)
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Before the polysomnography (one night)
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Emilia SFORZA, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06041451: Early and Late Prognosis in Patients With Guillain-Barre Syndrome
Official title: Early and Late Prognosis in Patients With Guillain-Barre Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Guillain-Barre Syndrome
Keywords: Guillain-barre syndrome
prognosis
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this observational study is to explore significant indicators to predict the early prognosis and late prognosis in patients with Guillain-Barre syndrome.

Detailed description: This is a multicenter study(approximately three) with over 450 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers, clinical characteristics and electromyography. All participants provided their written informed consent to participate in this study.

Eligibility criteria: Inclusion Criteria:

* patients fulfilled clinical, biological, and electrophysiology criteria for Guillain-barre syndrome.

Exclusion Criteria:

* nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome

Primary outcomes:
measure: the severity of Guillain-barre syndrome
timeFrame: baseline, at 1 week, at 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT02781051: Increasing Physical Activity Among Breast Cancer Survivors With Depression
Official title: Increasing Physical Activity Among Breast Cancer Survivors With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Physical Activity
Breast Cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2016-05-24
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pilot study to assess a multi-component intervention to increase physical activity among breast cancer survivors with depression.

Detailed description: The research project is a pilot study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors with depression. Individuals meeting inclusion/exclusion criteria will be enrolled in the 12-week intervention with a 6 month follow up. Intervention components will include print-based education, self-monitoring, Active Living counseling, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points during the intervention (Weeks 7, 13, and 25). Changes in physical activity will be assessed using Fitbits to measure weekly minutes of moderate/vigorous activity.

Eligibility criteria: Inclusion Criteria:

* Positive depression screen (PHQ-9) or current antidepressant treatment
* Report \<150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the GPAQ
* Physically able to engage in physical activity
* Written and verbal fluency in English

Exclusion Criteria:

* Medical condition contraindicating physical activity participation
* Recurrence of breast cancer
* Ductal carcinoma in situ (DCIS) diagnosis
* Cognitively unable to give informed consent
* Non-English speaking

Primary outcomes:
measure: Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer
timeFrame: 6 months
Secondary outcomes:
measure: Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR)
timeFrame: 6 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT01221051: Third Stage of Labor a Swedish Randomized Controlled Trial
Official title: A Comparison of Active and Expectant Management of the Third Stage of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childbirth
Keywords: third stage of labor,oxytocics, postpartum hemorrhage,
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2010-10-14
Enrollment: 1800
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose with this study was to compare blood loss and women's experience of afterpains during the third stage when handled with active or expectant management of the third stage of labour.

Hypothesis 1. To detect a 5% difference (15% vs 10%) in blood loss \>1000 mL between the two groups with 80% power (α=0.05), at least 726 subjects were required in each group.

Hypothesis 2. Afterpains are more pronounced in active compared to expectant management during the third stage of labour

Detailed description: Management of the third stage of labour has been focus for investigation during decades and active management of the third stage of labour (AMTSL)has been recommended in all women giving birth vaginally at hospitals. In Sweden the recommendation has been to give an injection of oxytocin immediately after birth of the neonate but not the entire AMTSL procedure.

Women in labour were asked to participate voluntarily when entering the hospital and after acceptance they were randomised to either active or expectant management of the third stage of labour(EMTSL).

AMTSL included:

* Early cord clamping
* 10 UI oxytocin i.v
* controlled cord traction
* uterine massage after placenta expulsion

EMTSL included:

* early cord clamping
* 2 mL saline solution i.v
* wait for signs of placenta detachment
* encourage the women to push out placenta by her own effort
* uterine massage after placenta expulsion

All blood was measured by weighing bed pads and sanitary towels up to two hours postpartum Assessment of afterpains was performed by a Visual Analogue Scale (VAS) and the Pain-o-meter (POM-WDS) two hours after the delivery of placenta, and the day after childbirth.

Eligibility criteria: Inclusion Criteria:

* healthy women with normal pregnancies
* gestational age of 34+0 - 43+0 weeks
* singleton, cephalic presentation
* expected vaginal birth

Exclusion Criteria:

* non Swedish-speaking
* previous PPH \>1000 mL
* elective Caesarean section
* pre-eclampsia
* grand multiparity (≥5)
* intrauterine fetal death

Primary outcomes:
measure: blood loss
timeFrame: blood loss measured up to two hours post partum
Secondary outcomes:
measure: afterpains
timeFrame: at two hours postpartum and the day after delivery
Other outcomes:
Locations:
Study officials:
affiliation: Sahlgrenska academy, University of Gothenburg
name: elisabeth jangsten
role: PRINCIPAL_INVESTIGATOR
References: