louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04843670: Isolated Pancreatic Loop With Modified Pancreaticojejunostomy
Official title: Modified Pancreaticojejunostomy Technique With Isolated Pancreatic Loop After Pancreaticoduodenectomy Reduces Postoperative Pancreatic Fistula: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreaticoduodenectomy
Keywords: Pancreaticoduodenectomy
pancreaticojejunostomy
Postoperative pancreatic fistula.
Lead sponsor: Université de Sousse
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 201
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients undergoing duodenopancreatectomy procedure, in the surgery department .

Brief summary: The aim of the present study was to observe whether the modified pancreatico- jejunostomy (PJ ) technique with an isolated pancreatic loop would effectively reduce the POPF rate and overall morbidity after PD

Detailed description: Postoperative pancreatic fistula (POPF) is widely regarded as the most threatening complication following pancreaticoduodenectomy (PD). Its clinical impact and sequelae have been previously described and shown to contribute to the development of other morbid complications and high rates of mortality.

The aim of the present study was to observe whether the modified pancreatico- jejunostomy (PJ ) technique with an isolated pancreatic loop would effectively reduce the POPF rate and overall morbidity after PD.

Methods: We report our early experience using a modified PJ technique with an isolated pancreatic loop after after PD in 201 patients between January 2010 and December 2020.

Eligibility criteria: Inclusion Criteria:

* age up to 30
* head of the pancreas tumor

Exclusion Criteria:

* body and tail pancreatic tumors

Primary outcomes:
measure: incidence of pancreatic fistula
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: university of sousse
name: ali ben ali, PROFESSOR
role: STUDY_DIRECTOR
References:
Clinical trial NCT00491270: Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
Official title: Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vaginosis, Bacterial
Abortion, Spontaneous
Premature Birth
Keywords: Vaginosis, Bacterial
Abortion, Spontaneous
Premature Birth
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
Collaborators: name: Common Sense
First posted: 2007-06-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To determine whether screening of pregnant women with history of previous preterm delivery or with premature contractions for bacterial vaginosis using VS-SENSE, and treatment of positive women will reduce the risk of spontaneous preterm birth.

Detailed description: This is an open-label, comparative, and prospective study. Pregnant women, pregnancy week 26 to 36+6, between the ages 18-45, who were hospitalized in the high risk department, with history of previous preterm delivery and/or with premature contractions. Patient with premature ruptured membrane will be excluded.

In the hospital pregnant women with history of previous preterm delivery or with premature contractions, (participants) will be examined by speculum with no lubricant, The clinician will use the VS-SENSE to sample vaginal secretions and will immediately observe and record the color obtained.Should the VS-SENSE produce positive results the physician will consider giving clindamycin treatment.

Eligibility criteria: Inclusion Criteria:

* Pregnant subjects, aged 18-45 years, pregnancy week 26 to 36+6, with history of previous preterm delivery or with premature contractions.

Exclusion Criteria:

* Subject with ruptured membranes.
* Subject with signs and symptoms of pelvic inflammatory disease.
* Subject who has used vaginal douching within 12 hours prior to arrival at the hospital.
* Subject who has applied local antiseptic, antibiotic or vaginal treatment within the previous 3 days.
* Subjects who have had sexual intercourse within the last 12 hours.
* Subject with blood in her vaginal secretions.
* Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study.
* Subject is unable or unwilling to cooperate with study procedures.

Primary outcomes:
measure: Does screening for BV using VS-SENSE in pregnant women with h/o preterm delivery or with premature contractions, and treatment will reduce or prevent Late miscarriage, preterm birth, preterm PROM, chorioamnionitis, and postpartum endometritis.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Department of Obstetrics and Gynecology
Study officials:
affiliation: Western Galilee Hospital-Nahariya
name: Jacob Bornstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03332875: OurRelationship.Com Effectiveness Study
Official title: OurRelationship.Com Effectiveness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Marital Conflict
Relationship, Marital
Keywords: OurRelationship
Couple therapy
Internet
Marriage Counseling
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 712
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Couples are randomized to receive either one call with a coach or four calls with a coach.
Primary purpose: TREATMENT

Brief summary: The purpose this study is to determine the continued reach and effectiveness of the OurRelationship.com program once paid advertising and payment for participation ceases. The answer to this question is essential to determining the sustainability of web-based interventions for couples. Specifically, this study has four aims:

1. Examine continued level of initial interest in the study, as measured by number of initial visits to the website, time spent on the page, and number of couples signing up for the study.
2. Measure any changes in the characteristics of the individuals expressing interest in the study, including demographics (e.g., race, ethnicity, education), relationship functioning (e.g., relationship satisfaction, previous help-seeking), and individual functioning (e.g., depression, anxiety)
3. Determine completion rates and effectiveness of the program once payments for participation have been removed.
4. Determine whether having a single Skype/phone call with a coach (rather than the four calls that were used in the NIH trial) significantly degrades completion rates.


Eligibility criteria: Inclusion Criteria:

* Currently in a heterosexual relationship
* Married, Engaged, or living with partner for 6 months or more
* Living in the United States
* Both partners score at least 0.5 standards below the community mean on relationship satisfaction

Exclusion Criteria:

* Clinically significant intimate partner violence
* Younger than 18 or older than 64 years of age
* Reporting infidelity in last three months
* Reporting severe suicidal ideation in last three months

Primary outcomes:
measure: Relationship satisfaction
timeFrame: Change between baseline and the end of the intervention (approx. 2 months later)
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Change between baseline and the end of the intervention (approx. 2 months later)
measure: Anxiety symptoms
timeFrame: Change between baseline and the end of the intervention (approx. 2 months later)
Other outcomes:
Locations:
Study officials:
References:
citation: Roddy MK, Rothman K, Doss BD. A randomized controlled trial of different levels of coach support in an online intervention for relationship distress. Behav Res Ther. 2018 Nov;110:47-54. doi: 10.1016/j.brat.2018.09.002. Epub 2018 Sep 13.
Clinical trial NCT05571475: The Effects of Simulated Competition on Repeated-sprint Cycling Performance
Official title: The Effect of Simulated Competition on Repeated-sprint Cycling Performance and on Measures of Physiological and Psychological Stress.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Lead sponsor: St Mary's University College
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Sprint cycling performance has been found to be reduced when two sprints were undertaken 12 minutes apart. In a follow-up study, the investigators found evidence to suggest that some of the loss in performance that was experienced in the second sprint was due to a psychological, rather than a physiological, limitation. It is conceivable that this loss in performance would not exist during a competition. The aim of this study is, therefore, to investigate the influence that a competitive environment has on repeated-sprint performance.


Eligibility criteria: Inclusion Criteria:

* regular strength/sprint training (at least 2 sessions per week)

Exclusion Criteria:

* Injured or a contraindicative medical condition

Primary outcomes:
measure: Sprint Power Output
timeFrame: From baseline to completion, ~42 days
Secondary outcomes:
measure: Heart-rate Variability
timeFrame: From baseline to completion, ~42 days
measure: Salivary Concentration of Alpha Amylase
timeFrame: From baseline to completion, ~42 days
measure: 20 cm Visual Analogue Scale to Assess Anxiety
timeFrame: From baseline to completion, ~42 days
measure: 20 cm Visual Analogue Scale to Assess Self-efficacy
timeFrame: From baseline to completion, ~42 days
measure: Sport Anxiety Scale-2 - a questionnaire to assess cognitive and somatic anxiety.
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05795075: Randomized Control Trial Comparing CMPAT and MAT for Lumbar Puncture
Official title: Computerized Modified Paramedian Approach Technique（CMPAT） Versus Conventional Midline Approach Technique（MAT） of Lumbar Puncture: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: a Randomized Controlled Trial
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The lumbar puncture (LP) technique is a widely utilized method for diagnosis and treatment purposes. Recently, the paramedian approach technique (PAT) has garnered increasing interest due to its advantages over the midline approach technique (MAT), which has traditionally been used for LP in clinical practice . Utilizing digital virtual human and computer simulation techniques, a new path has been proposed for the computerized modified paramedian approach technique (CMPAT). As such, the objective of the present study is to present a randomized controlled trial (RCT) protocol to investigate and compare the effects of CMPAT versus MAT in patients requiring LP.


Eligibility criteria: Inclusion Criteria:

* Aged 18-70 years. Indication for LP.（Diagnostic lumbar puncture：Cerebrospinal fluid composition analysis，Cerebrospinal fluid pressure measurement；Cerebrospinal fluid release or lumbar Contiuous drainage of fluid，Intrathecal injection of lumbar cistern, etc.） Informed consent. Sufficient knowledge of the Chinese language to complete forms and follow instructions independently.

Exclusion Criteria:

* Cerebral hernia or high Cerebrospinal fluid pressure that might lead to Cerebral hernia.

Treatment with oral anticoagulant or anti-small plate(3 days or less)or coagulation disorders, various factors leading to a higher risk of bleeding.

Local infection or skin breakdown. Previous surgery on Lumbar spine segments. Pregnancy or lactation Severe somatic or psychiatric illness.（Severe anxiety or depression, etc.） Failure to be followed up as needed or worries about the potential risks of the study.

Failure to provide written informed consent or follow the protocol requirements.

Expected survival time being less than 1 month. Plan to emigrate within 1 month. Other conditions that are unsuitable for clinical research.

Primary outcomes:
measure: Number of puncture attempts in case of successful LP
timeFrame: 1 day
measure: LP success rate
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT05070975: Severity of RSV Infections in Twins
Official title: Phenotype Severity of RSV-infections in Twins During the First Year of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: RSV Infection
Bronchiolitis
Keywords: RSV infections in twins
Bronchiolitis
very-severe-LRTI
severe-LRTI
LRTI
upper respiratory tract infection
RSV infection
Human
infant
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 94
Sex: ALL
Maximum age (years): 354
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twins identified from the birth cohort (Hospices Civils de Lyon) with at least one twin hospitalized for an acute RSV-infection

Brief summary: Respiratory syncytial virus (RSV) infection is the most common cause of severe lower respiratory tract infection (LRTI) in the pediatric population worldwide. Age at the time of infection, prematurity, multiparity, exposure to smoke and the level of passive immunity transmitted at birth are the main risk factors for lower respiratory infection associated with RSV. Other factors, including the innate immune response, respiratory microbiota, and intra-host viral heterogeneity, may also affect outcomes but are not fully considered in RSV infection. Exploring the impact of these factors is difficult due to the heterogeneity of the population which makes statistical adjustment difficult. Thus, twin models are useful in understanding the impact of the host on the environment, as twins often share similar exposure to infection and many risk factors, but not all are ie different prenatal and postnatal conditions, differential transfer of maternal antibodies and the genetic makeup of heterozygotes.


Eligibility criteria: Inclusion Criteria:

* Twins born at Hospices Civils de Lyon in the years 2012 to 2020
* At least one twin hospitalized with positive RSV-PCR during the first year of life

Exclusion Criteria:

* Major differential underlying disease between twins
* Death of a twin before the RSV epidemic period of the first year of life
* Nosocomial infection
* Lack of understanding of the study or questionnaire by parents
* Lack of parental consent

Primary outcomes:
measure: Percentage of discordant twin pairs in severity of Respiratory Syncytial Virus infections.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT04319575: Comparison of Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide as a Root Canal Disinfectant
Official title: Clinical and Radiographic Comparative Evaluation of Healing of Periapical Lesion Using Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide When Used as a Root Canal Disinfectant- An In Vivo Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Periapical Abscess
Lead sponsor: Dr. D. Y. Patil Dental College & Hospital
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators observed the clinical and radiographic healing of periapical lesion using Chitosan mixed with calcium hydroxide and compared it with triple antibiotic paste when used as intracanal medicament in 3months, 6 months and 12 months.

Detailed description: Aim: To evaluate and compare the healing of periapical lesions using chitosan mixed with calcium hydroxide or Triple Antibiotic Paste at 3,6 and 12 months.

Methodology:

20 adult patients having periapical lesions in single rooted teeth were selected in this study after being assessed using the PAI index. Patients were randomly assigned to: Group - I (n=10) Chitosan with Ca (OH)2 and Group -II (n=10) Triple Antibiotic paste (TAP)

After access opening and cleaning and shaping were done in the first visit, the pertinent intracanal medicaments were placed depending on the patient group. After 4 weeks, on the second visit, the medicament was removed andobturation was done in the asymptomatic teeth. Both clinical and radiographic endodontic evaluation was done at 0, 3, 6 and 12months using the same parameters.

Radiographic evaluation was done using the PAI Index and was compared at 0, 3, 6, and 12 months after treatment, Z Test.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 40 years Periapical lesion (not more than 5mm) radiographically.on single rooted teeth
* Roots with closed apex.
* Systemically healthy patients.

Exclusion Criteria:All patients who respond positive to allergic patch test \[triple antibiotic paste\] and drugs.

* Teeth with previous endodontic therapy performed.
* Patients with a history of any systemic diseases.
* Pregnant and lactating women.
* Tooth associated with vertical root fracture and coronal perforation.
* Tooth affected with calcific degeneration.
* Presence of external or internal root resorption.
* Blunderbuss apex.

Primary outcomes:
measure: healing of periapical lesion
timeFrame: change in PAI index from baseline to 3 months, baseline to 6 months and baseline to 12 months
Secondary outcomes:
measure: patient pain perception
timeFrame: 3months, 6months and 12 months
Other outcomes:
Locations:
city: Pune
country: India
facility: Dr DY Patil Dental College And Hospital (DPU)
state: Maharashtra
Study officials:
affiliation: Dr. D Y Patil Dental College, Pimpri, Pune
name: Piyush D Oswal, MDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00557375: Brain Tumor Treatment Satisfaction Survey
Official title: Treatment Satisfaction Survey for Brain Tumor Patients and Their Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumors
Keywords: Brain Tumors
Survey
Lead sponsor: Methodist Healthcare
Sponsor class: OTHER
First posted: 2007-11-14
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Brain tumor patients and their caregivers

Brief summary: Patients with recent diagnosis and treatment of a brain tumor will complete a short questionnaire concerning the patient's quality of life and emotional state since receiving treatment. Caregivers will complete a one-page questionnaire concerning the patient's quality of life and emotional state since receiving treatment.

Detailed description: Patients with a recent diagnosis and treatment of a brain tumor (primary or metastatic; N=105, 61% female, 39% male) were identified in the clinics of Semmes-Murphey Neurologic and Spine Institute or the Methodist University Hospital in Memphis, TN. Caregivers were recruited from among relatives and friends who provide the most day-to-day care to the patient. All participants were between 3 months and 1 year from their most recent brain tumor treatment. Participants were given a simple, 5-point based survey to asses treatment-specific satisfaction, patient education, posttreatment quality of life, and pre- and post-treatment emotional impact. Therapeutic modalities surveyed include: surgery, external beam radiotherapy, whole-brain radiotherapy, stereotactic radiosurgery, and chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Patients who are between 3 months and one year out from treatment for their brain tumor
* Karnofsky Performance Status (KPS) \>= 60
* Age 18 years or over, any gender, any race
* "patient caregivers will be individuals who provide the most day-to-day care for their respective brain tumor patients

Exclusion Criteria:

* No exclusions

Primary outcomes:
measure: Overall satisfaction and emotional impact of treatments in patients who have undergone therapy(s)for brain tumors.
timeFrame: (greater than or equal to 3 months) from first treatment for brain tumor
Secondary outcomes:
measure: Observational data about the treatment course and emotional well-being of the brain tumor patient as provided by the caregiver.
timeFrame: (Greater than or equal to 3 months) from first treatment for brain tumor
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
Study officials:
affiliation: Methodist Healthcare
name: Jeffrey M. Sorenson, MD
role: PRINCIPAL_INVESTIGATOR
References: