louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00653367: Evaluation of Chronic Pain After Nerve Section During Thoracotomy
Official title: Post Thoracotomy Pain After Nerve Section
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lung Cancer
Keywords: Thoracotomy
Nerve section
QST
Quantitative Sensory Test
Muscle sparing Posterolateral thoracotomy
Chest
Wall
Surgical
Incision
Tumors or cancer of the lung
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2008-04-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate if controlled nerve section reduces chronic pain after thoracotomy.


Eligibility criteria: Inclusion Criteria:

* Patients included for anterior or lateral thoracotomy

Exclusion Criteria:

* Unable to give consent due to age, cognitive reduction or otherwise
* Neurological disease or symptoms affection thoracic area
* Chronic pain prior to surgery
* Inability to supply the patient with an epidural catheter
* Pneumonectomy
* Prolonged infection at surgical site
* Invasive tumor growth
* Need for repeated surgery at site

Primary outcomes:
measure: Pain (NRS)
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: QST parameters (sensory thresholds to cool/Warmth)
timeFrame: 3 months postoperatively
measure: Social well-being (HADS / PCS)
timeFrame: 3 months postoperatively
measure: Function (pain impairment of Activities of Daily Life)
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Section for Surgical Pathophysiology 4074
Study officials:
affiliation: Section for Surgical Pathophysiology 4074
name: Kim Wildgaard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Section for Surgical Pathophysiology 4074
name: Henrik Kehlet, MD, Phd, Pro
role: STUDY_CHAIR
References:
Clinical trial NCT00005467: Indices of Severity and Prognosis for Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia, Sickle Cell
Blood Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To develop a clinical severity index that could prospectively identify sickle cell disease patients who were at high risk for a turbulent clinical course and a poor prognosis.

Detailed description: DESIGN NARRATIVE:

Using the database, univariate analysis showed that factors associated with the occurrence of cerebrovascular accident (51 patients) included hematocrit, rate of change of pocked red cell count, and polymer fraction at 40 percent oxygen saturation (PF40). Only low hematocrit was predictive of death in the pediatric cohort. There were 45 disease-related deaths.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bray GL, Muenz L, Makris N, Lessin LS. Assessing clinical severity in children with sickle cell disease. Preliminary results from a cooperative study. Am J Pediatr Hematol Oncol. 1994 Feb;16(1):50-4.
Clinical trial NCT03597867: PGE2 Levels in Patient Treated With NSAIDs
Official title: Vitreous pge2 Level Changes After Topical Administration of Diclofenac 0.1%, Nepafenac 0.3%, Indomethacin 0.5% and Bromfenac 0.09% in Vitrectomy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Inflammation
Keywords: vitreoretinal surgery
epiretinal membrane
macular hole
non steroidal antinflammatory drugs
prostaglandin E2
Lead sponsor: University of Trieste
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 104
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine vitreous levels of nonsteroidal antinflammatory drugs (NSAIDs) and prostaglandinE2 (PGE2) in eyes scheduled for vitrectomy.

All patients received the study drugs for 3 days before surgery. 0.5 to 1.0 mL of undiluted vitreous was removed using the vitreous cutter positioned in the midvitreous cavity. Samples were immediately frozen and stored at -80°C until analysis.

Sample analyses were performed using an high-performance liquid chromatography system. The lower limit of quantitation was 0.8 ng/mL.

PGE2 levels were analyzed using the Prostaglandin E2 Monoclonal EIA Kit (Cayman Chemical Company) according to the manufacturer's instructions.


Eligibility criteria: Inclusion Criteria:

* epiretinal membrane or full thickness macular hole scheduled for vitrectomy

Exclusion Criteria:

* vitreous hemorrhage
* diabetes
* glaucoma
* concurrent retinovascular disease
* previous ocular inflammation
* previous ocular surgery
* history of ocular trauma
* previuos intravitreal injections
* concomitant intake of topical or systemic NSAIDs or corticosteroid therapy

Primary outcomes:
measure: Vitreous NSAIDs and PGE2 levels
timeFrame: 3 days after topical NSAID administration
Secondary outcomes:
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste
state: TS
Study officials:
affiliation: Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste Trieste, TS, 34129, Italy
name: Marco R Pastore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02178267: Probiotics On Resistant Bacteria Colonization In Preterm Receiving Antibiotics
Official title: Effect Of Probiotics On Resistant Bacteria Colonization Preterm Newborn Infants Receiving Antibiotics In Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Keywords: Newborn, preterm, probiotic, resistant microorganisms
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2014-06-30
Enrollment: 51
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In this study, the investigators investigated the effect of probiotic use on colonization of resistant microorganisms in newborn preterm infants receiving antibiotics. This study of the use of probiotics in preterm neonates in neonatal intensive care units expect to prevent colonization by resistant microorganisms.

Detailed description: The gut which is sterile in newborn preterm infants begins to colonize with birth. Factors such as developmental immaturity of the immune system, encountering with the flora of neonatal intensive care unit, exposure to diagnostic and therapeutic interventional procedures, use of antibiotics, delay of enteral feeding may poorly affect the development of natural and mucosal immunity of intestine in newborns preterm during postnatal period. Exposure to these factors, newborn preterm infants' life threatens especially to change the development of the normal intestinal flora and intestinal immunity. Many randomized controlled studies reported that probiotics reduce intestinal inflammatory process and prevent colonization with pathogenic microorganisms of the intestines . In this study, the investigators investigated the effect of probiotic use on colonization of resistant microorganisms in newborn preterm infants receiving antibiotics.

Eligibility criteria: Inclusion Criteria:

* The study were included ≤36 weeks gestational age newborn preterm infants requiring antibiotic treatment and/or prophylaxis.

Exclusion Criteria:

* Newborn preterm infants who are congenital anomalies and not require antibiotic therapy and undergoing intestinal operation were excluded from the study.

Primary outcomes:
measure: The use of probiotics in newborn preterm infants receiving antibiotics will be investigated type of resistant microorganisms in the flora of intestinal and nasal.
timeFrame: Up to 12 month
Secondary outcomes:
measure: Types Of Resistant Microorganisms In The Culture
timeFrame: Up to 12 month
Other outcomes:
Locations:
Study officials:
affiliation: Baskent University
name: Abdullah Kurt, Neonatology
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05923567: New Predictive Marker for Pancreatic Cancer Using CA19-9 and Fecal Elastase
Official title: Novel Predictive Strategy Using CA19-9 and Fecal Elastase Levels to Make Treatment Decisions for Resectable Pancreatic Cancer; Retrospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Paancreatic Cancer
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The clinical data of patients with resectable pancreatic cancer from two hospitals were analyzed. The cut-off points of preoperative CA19-9 and FE-1 levels were extracted from the Youden index and previous studies (385 U/ml and 100 µg/g stool, respectively). Cox proportional hazard models were used to investigate the association between preoperative tumor marker levels and survival (3-overall survival and 1-year recurrence free survival) after surgery.

Brief summary: Background Carbohydrate antigen 19-9 (CA19-9) is used as a marker to predict recurrence and survival of patients with Pancreatic cancer(PDAC). Recently, fecal elastase-1(FE-1), a marker of pancreatic exocrine function, has been shown to correlate with prognosis in patients with PDAC. However, there have been no studies that have predicted prognosis by combining these two factors. In this study, investigators developed a predictive strategy for prognosis of PDAC using data on preoperative CA19-9 and FE-1 levels.6

Methods The clinical data of patients with resectable pancreatic cancer from two hospitals were analyzed. The cut-off points of preoperative CA19-9 and FE-1 levels were extracted from the Youden index and previous studies (385 U/ml and 100 µg/g stool, respectively). Cox proportional hazard models were used to investigate the association between preoperative tumor marker levels and survival (3-overall survival and 1-year recurrence free survival) after surgery.


Eligibility criteria: Inclusion Criteria:

* Investigators conducted a retrospective study using data from 857 patients with pancreatic cancer enrolled in two hospitals in the Republic of Korea (179 from Gangnam Severance Hospital and 678 from Seoul National University Hospital) from January 5, 2010 to December 31, 2019.

Exclusion Criteria:

* Investigators excluded patients without information about preoperative tumor marker levels (n = 45), those who received neoadjuvant (n = 169), those with preoperative CA19-9 levels \< 9.0 \[Lewis antibody-negative patients\] (n = 98), those with missing covariates (n = 3) and R2 resection (n = 6).

Primary outcomes:
measure: 3yr overall survival
timeFrame: Survival period from surgery date, 3 years
Secondary outcomes:
measure: 1yr disease free survival
timeFrame: Period without recurrence from the date of surgery, one year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT06290167: A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab
Official title: A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Decline
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The main objective of this project is two-fold

1. to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity
2. to investigate its efficacy in improving the cognitive functioning in a randomized clinical trial for 2 different populations: subjects with subjective memory complaints and mild cognitive impairment.

Specifically, participants will follow an integrated training including 2 phases: 1)in-hospital rehabilitation, where subjects will be provided sessions of the training in immersive modality; 2)at-home rehabilitation, where older adults will be asked to perform at home the non-immersive version of the training using a tablet.

Expected outcome is an improvement in cognitive functioning (assessed with a complete neuropsychological battery) after the training, thus advancing literature about non-pharmacological interventions in the preclinical stages of dementia along with innovative technical instruments.


Eligibility criteria: Inclusion Criteria (group of SMC):

* \> 65 years old
* self-reported memory complaints
* score on Mini-Mental State Examination greater than or equal to 27/30 (normal range)

Exclusion Criteria:

* no evidence of objective impairments on the neuropsychological testing, scores on the Clinical Dementia Rating \< 0.5

Inclusion Criteria (group of MCI):

* \> 65 years old
* a self-reported (or reported by a caregiver) cognitive decline
* an objective impairment on the neuropsychological testing
* scores on the Clinical Dementia Rating \< 0.5.

Exclusion Criteria:

* no dementia

Primary outcomes:
measure: Cognitive functions
timeFrame: Immediately after the training experience
measure: Motor functions
timeFrame: Immediately after the training experience
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
state: MI
Study officials:
References:
Clinical trial NCT07016867: Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment
Official title: Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment in Management of Male Subfertility With Isolated Teratozoospermia: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Teratozoospermia
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 126
Sex: MALE
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: A varicocele is defined as an abnormal venous dilatation and/or tortuosity of the pampiniform plexus in the scrotum. Although varicoceles are almost always and more common on the left side, up to 50% of the men with varicocele, have bilateral varicoceles.

Varicocele has a negative impact on spermatogenesis, testicular volume, Standard semen parameters, and fertilization, implantation, and embryo outcomes.

Detailed description: Varicocelectomy remains the first-line treatment option in infertile men with palpable varicocele and abnormal semen parameters, with the microsurgical subinguinal approach conveying the greatest success rate and fewest complications. The empirical use of antioxidant supplement may confer some benefits in men to reduce oxidative damage.

Medical management, including antioxidants, could offer a potential solution with lower risks given the increasing evidence suggesting the role of oxidative stress in varicocele-induced infertility.

Physical examination of the scrotum remains the most commonly used technique to diagnose varicoceles. Palpation of the scrotum is best performed in a relaxed patient in standing position, in a warm room and carried out by a well-trained physician.

Surgical treatment of varicocele has a significant effect on semen parameters, so it is considered the 'gold standard' treatment for subfertile males with palpable varicoceles associated with abnormal semen analysis.

Eligibility criteria: Inclusion Criteria:

* Sub-fertile men with clinically palpable varicoceles ( unilateral or bilateral ).
* Men with teratozoospermia.

Exclusion Criteria:

* Recurrent varicoceles.
* Significant medical diseases as: Hepatic insufficiency.
* Hypersensitivity to the drugs.
* Female factor of infertility.

Primary outcomes:
measure: Number of participants with Treatment of Teratozoospermia
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University Hospital
state: South Valley
Study officials:
affiliation: Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt
name: Mohammad Sayed Abdel-Kader, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04957667: Scintigraphic Defecography for Evaluation of Functional Outcome in an Adult Hirschsprung Population
Official title: Scintigraphic Defecography for Evaluation of Functional Outcome in an Adult Hirschsprung Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hirschsprung Disease
Keywords: Hirschsprung disease
Scintigraphic defecography
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 32
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients operated for Hirschsprung's disease from 1985-2014 are gathered in a cohort, intended for several studies on Hirschsprung's disease. All patients \> 15 years from this cohort will be invited to participate in this study.

Brief summary: This study aims to investigate long term outcomes of surgical intervention for Hirschsprung's disease and to explore the relation between scintigraphic defecography, type of surgery performed and symptoms as evaluated by a disease specific questionnaire.

Detailed description: Hirschsprung's disease (HD) is a congenital deficiency with incomplete development of nerves in the gastrointestinal tract leading to absence of peristalsis in the affected segment of bowel. Most patients require surgical intervention with removal of the affected segment of bowel. Physical symptoms affecting quality of life are not uncommon in patients born with HD in spite of surgical intervention. This renders a need for a tool for evaluating the functional outcome in these patients.

Scintigraphic defecography examines the defecation in terms of the ability to empty the bowel and examines the relocation of faeces within the bowel in relation to defecation.

This study aims to explore the relation between scintigraphic defecography, type of surgery performed and symptoms as evaluated by a disease specific questionnaire (Hirschsprung and Anorectal Malformations Quality of Life Questionnaire).

Eligibility criteria: Inclusion Criteria:

* Patients operated with any type of surgery for Hirschsprung's disease between 1985-2014
* Age \> 15 years

Exclusion Criteria:

* Unable to understand given instructions in relation to the defecography (ex. retarded)
* Pregnancy
* Missing consent

Primary outcomes:
measure: Evacuation fraction (%) of radioactive material between first, second and third round of scintigraphic imaging
timeFrame: Day 1
measure: Presence of retrograde movement of radioactive material (yes/no)
timeFrame: Day 1
measure: Hirschsprung and Anorectal Malformations Quality of life Questionnaire sub scales and total score
timeFrame: Day 1
measure: Type of surgical intervention performed in each individual (for example pull-through surgery)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region Syddanmark
Study officials:
References:
Clinical trial NCT02218567: Behavioural Problems in Huntington Disease : Analysis and Enhancement of Caregiver and Patient Experience
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Huntington Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2014-08-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study hypothesis is that caregivers experience allows them to develop a lot of knowledge and know-how about behavioural problems in Huntington Disease and its consequences. The purpose of this study is to collect, describe and analyse caregivers experience in order to find and enhance their knowledge related to the adaptation to behavioural problems of Huntington Disease patients.


Eligibility criteria: Inclusion Criteria:

* For patients:

  * Patients with Huntington Disease declared
  * Huntington Disease diagnosed with abnormal number of CAG repeats: 38 \< nucleotide expansion (CAG)
  * Total Functional Capacity ≥ 7
  * Patients living with a caregiver
  * Aged 18 years and above
  * Subject gave its written consent
* For caregivers :

  * No risk of caregiver having Huntington disease
  * Aged 18 years and above
  * Subject gave its written consent

Exclusion Criteria:

* For patients:

  * Patient who do not live with a caregiver
  * No national health insurance affiliation
  * Being under guardianship
* For caregivers :

  * Caregiver at risk for Huntington Disease
  * No national health insurance affiliation
  * Being under guardianship

Primary outcomes:
measure: The Huntington's Disease health-related Quality of Life questionnaire
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital of Angers
state: Maine Et Loire
Study officials:
References: