louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05984212: Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery
Official title: Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Single Port Laparoscopic Adnexal Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the investigators aimed to demonstrate if the quality of recovery in patients undergoing single-port laparoscopic adnexal surgery, with preoperative rectus sheath block and intraoperative opioid administration based on analgesia nociception index, improves compared to the patients without block.


Eligibility criteria: Inclusion Criteria:

1. Adult female patient aged 19 years or older undergoing elective single-port laparoscopic adnexal surgery under general anesthesia at Yonsei Cancer Center

1. patients with moderate to severe pain before surgery 2. patients with history of taking chronic analgesic use, 3. patients allergic or hypersensite to remifentanil or local anesthetic (ropivacaine), 4. patients with infection at the site of the block, 5. patietns who cannot communicate

Primary outcomes:
measure: Quality of Recovery 40 scale score at postoperative 24 hour
timeFrame: 24 hours after the end of surgery
Secondary outcomes:
measure: Intraoperative remifentanil consumption,postoperative pain score
timeFrame: at 0, 1, 6, 12, and 24 hours postoperative
measure: rescue analgesics administered up to 24 hours postoperatively
timeFrame: intraoprative and postoperative 24hours
measure: satisfaction with pain control
timeFrame: intraoprative and postoperative 24hours
measure: serum cortisol level (μg/dL) before and after surgery
timeFrame: intraoprative and postoperative 24hours
measure: leukocyte level (10^3/μL) before and after surgery
timeFrame: intraoprative and postoperative 24hours
measure: arterial pH before and after surgery
timeFrame: intraoprative and postoperative 24hours
measure: blood glucose level (mg/dL) before and after surgery
timeFrame: intraoprative and postoperative 24hours
measure: measurement of adequate analgesia (NRS <4) before and after surgery
timeFrame: intraoprative and postoperative 24hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
name: Youngwon Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01552512: Nutributter Programming to Prevent Undernutrition: an Evaluation
Official title: Randomized Control Trial of Complementary Food to Prevent Undernutrition Among At-Risk Infants in Fort San Michel, Haiti
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Keywords: Stunting
Hidden Hunger
Diarrhea
Vitamin A Deficiency
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: World Bank
name: United Nations World Food Programme (WFP)
First posted: 2012-03-13
Enrollment: 1228
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized, controlled effectiveness study examines Nutributter programming within an integrated package of maternal and child health services offered by Haiti's Ministry of Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the process evaluation is to better understand the uptake of Nutributter® as a complementary food in the diets of young children and its feasibility and acceptability as part of MSPP's package of services. This project is being carried out at a public hospital in Fort San Michel, an impoverished community outside of Cap Haitien, Haiti.


Eligibility criteria: Inclusion Criteria:

* Infants 6 to 12 months old
* Lives in Fort San Michel

Exclusion Criteria:

* Moderately or severely malnourished
* Peanut allergy

Primary outcomes:
measure: Change in Length for Age
timeFrame: Once per month for 6 months, then once after 12 months.
Secondary outcomes:
measure: Change in Weight for Height
timeFrame: Once per month for 6 months, then once after 12 months
Other outcomes:
Locations:
city: Cap Haitien
country: Haiti
facility: Hopital Fort San Michel
Study officials:
affiliation: Washington University School of Medicine
name: Lora Iannotti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iannotti LL, Dulience SJ, Green J, Joseph S, Francois J, Antenor ML, Lesorogol C, Mounce J, Nickerson NM. Linear growth increased in young children in an urban slum of Haiti: a randomized controlled trial of a lipid-based nutrient supplement. Am J Clin Nutr. 2014 Jan;99(1):198-208. doi: 10.3945/ajcn.113.063883. Epub 2013 Nov 13.
Clinical trial NCT04337112: The Expanded Access Use of Viltolarsen in Duchenne Muscular Dystrophy With Confirmed Exon 53 Amenable Mutation
Official title: The Expanded Access Use of Viltolarsen for the Treatment of Duchenne Muscular Dystrophy (DMD) Amenable to Exon 53 Skipping
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Muscular Dystrophy, Duchenne
DMD
Keywords: Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Lead sponsor: NS Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-07
Sex: MALE
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD

Brief summary: This is an open label expanded access program for boys, 3 to 12 years old, for the treatment of Duchenne muscular dystrophy (DMD) with confirmed mutation(s) in the dystrophin gene that is amenable to skipping of exon 53.

Detailed description: This expanded access program is designed to provide access to viltolarsen in patients with DMD with confirmed mutation(s) in the dystrophin gene amenable to skipping of exon 53, who in the opinion and clinical judgement of the treating physician, would benefit from treatment with viltolarsen.

Eligibility criteria: Inclusion Criteria:

* Male ≥ 3 and ≤ 12 years of age
* Clinical signs compatible with DMD
* Confirmed DMD mutation(s) in the dystrophin gene that is amenable to skipping of exon 53 to restore the dystrophin messenger ribonucleic acid (mRNA) reading frame
* Able to walk independently without assistive device
* Not able to participate in a Phase 3 trial

Exclusion Criteria:

* Chronic systemic fungal or viral infections
* An acute illness within 4 weeks prior to the first dose of viltolarsen
* Symptomatic cardiomyopathy
* Patient has a previous or ongoing medical condition, medical history, physical findings, or laboratory abnormality that could affect participant safety in the opinion of the treating physician
* Surgery within the 3 months prior to the first anticipated administration of viltolarsen and in the opinion of the treating physician would impact weekly treatment schedule
* Positive test results for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) antibody at screening
* Currently taking any other investigational drug or has taken any other investigational drug within 3 months prior to the first dose of viltolarsen
* Previously enrollment in any viltolarsen study.
* Currently taking any other exon skipping agent or has taken any other exon skipping agent within 2 weeks prior to the first dose of viltolarsen (would need to be discontinued in order to be eligible)
* Any gene therapy for DMD
* Inadequate renal function as defined by a serum cystatin C \> 1.5 x upper limit of normal (ULN). If the value is \> 1.5 x ULN then the measurement can be repeated once. If repeat measurement is still \> 1.5 x ULN then the patient should be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03129412: Oligo-metastases NPC Patients Received Radiation for Primary Tumors and Treatments for Metastatic Lesions
Official title: The Clinical Curative Efficacy and Side Effect of Oligo-metastases Nasopharyngeal Carcinoma Patients Received Radical Radiation for Primary Tumors and Treatments for Metastatic Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Cancer
Neoplasm Metastasis
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 64
Sex: ALL
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: Oligo-metastases NPC patients received radiation for primary tumors and treatments for metastatic lesions.

Detailed description: The patients enrolled will received 4-6 cycles chemotherapy at first.Then, radical radiotherapy for nasopharyngeal tumors and local treatments for oligometastatic lesions will assigned to those patients. The efficacy and side-effect will be evaluated and analyzed.

Eligibility criteria: Inclusion Criteria:

1. Histologically conformed initial non-keratinizing squamous carcinoma in nasopharynx.
2. Clinical stages,T1-4N0-3M1，IVc(AJCC 2010).
3. The metastatic lesions ≤5 and metastatic organs ≤2
4. Karnofsky scores \>70
5. Normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/L, neutrophil count\>1.5×109/L, platelet count \>100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
6. Informed consent signed.

Exclusion Criteria:

1. Histologically conformed initial keratinizing carcinoma or others.
2. The metastatic lesions \>5 or metastatic organs \>2.
3. Any severe complications contraindicated chemotherapy or radiotherapy.
4. History of malignant tumors.
5. Pregnant or nursing women.
6. History of radiotherapy or chemotherpy in head and neck regions.
7. Patients refused the informed consent.

Primary outcomes:
measure: Overall survival
timeFrame: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcomes:
measure: Progress free survival
timeFrame: From date of diagnosis until the date of first documented progression, assessed up to 36 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT05993312: Quality of Life in Traumatic Brain Injury Patients
Official title: Quality of Life in Traumatic Brain Injury Patients: Assessment at Discharge From an Intensive Care Unit.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: All Adult Patients Admitted to theHMPIT ICU for Management of Head Trauma
Lead sponsor: General Administration of Military Health, Tunisia
Sponsor class: NETWORK
First posted: 2023-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Collection of patients: medical data from the ICU medical record. Data collection of quality of life : outpatient clinic: the interview will be conducted by telephone.

If number phone patient cannot be reached, the questionnaire will be sent by post to the patient's address

Brief summary: The aim of this study is to describe the quality of life of CT patients in our study, at least 6 months after the occurrence of the trauma. This assessment is related to the patient's degree of sequelae, using the GOSE scale.

Detailed description: The assessment of patients quality of life would appear to be a particularly relevant tool in the ongoing drive to improve the quality of care. Thus, we should no longer simply assess how patients "should feel", based on objective biomedical criteria, but how they actually "perceive" themselves, based on subjective criteria.

This is particularly true in the case of traumatic brain injury , which is a high-incidence pathology with significant morbidity and mortality consequences that can lead to permanent sequelae . While research over the past 30 years has focused on the neuropsychological and functional outcomes of this event, less is known about the views of head injury survivors and their families on their quality of life, subjective well-being and related factors.

The aim of this study is to describe the quality of life of CT patients at least 6 months after the trauma. This assessment is related to the patient's degree of sequelae, using the Glasgow Outcome Scale Extended GOSE.

Eligibility criteria: Inclusion Criteria:

All adult patients (age 18 or over) admitted to the HMPIT intensive care unit for management of head trauma (isolated or as part of a polytrauma).

Exclusion Criteria:

Patients lost to follow-up after discharge. Incomplete ICU medical records. Patients or their families who refused to participate in the study.

Primary outcomes:
measure: quality of life in patients with BI / The short form12 SF12 questionnaire
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military Hospital of Tunis
state: Montfleury
city: Tunis
country: Tunisia
facility: Service de réanimation
state: Montfleury
Study officials:
affiliation: hopital militaire de TUNIS
name: Aicha N REBAI
role: STUDY_CHAIR
References:
Clinical trial NCT04668612: Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
Official title: Lowering Postprandial Hyperglycemia With Dual-wave Insulin Boluses in Children With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
Collaborators: name: Estonian Research Council
First posted: 2020-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized open-label single-center crossover clinical study
Primary purpose: TREATMENT

Brief summary: To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.

Detailed description: Primary objective To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.

Primary endpoint To compare time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.

Trial design This is a 28-day long prospective randomized open-label single-center crossover clinical study with a 14-day long run-in phase.

Trial population A total of 30 subjects with type 1 diabetes.

Eligibility criteria: Inclusion Criteria:

1. Children aged 7-18 years treated at the Children's Clinic of Tartu University Hospital for type1 diabetes.
2. Insulin pump and CGM initiated at least 3 months prior to the recruitment.
3. Estimated HbA1c based on the 14-days CGM report above 8.5%.
4. Daily insulin dose of more than 0.5 international units per kilogram.

Exclusion Criteria:

1. Subjects with known diabetes complications.
2. Elevated tissue transglutaminase IgA antibodies in the last two years.
3. Children who developed an acute viral infections during the week preceding the recruitment.

Exclusion criteria after the Run-in period

1. Basal insulin proportion \> 55% of daily insulin dose.
2. Children with any symptoms of an infectious disease or acutely sick during the last two weeks.
3. Estimated HbA1c \> 8.5% based on the 14-days CGM report.

Primary outcomes:
measure: Time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
timeFrame: 14 days
Secondary outcomes:
measure: Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
timeFrame: 14 days
measure: Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus
timeFrame: 14 days
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
References:
Clinical trial NCT01943812: Substituted Frozen Embryo Transfer Cycles With GnRH-agonist Supplementation
Official title: Substituted Frozen Embryo Transfer Cycles With GnRH-agonist Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy Loss
Frozen Embryo Transfer
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 287
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare two FET protocols by modifying the substituted FET cycle in order to maintain a higher ongoing positive pregnancy rate and thus reduce the early pregnancy loss.

Hypothesis: adding GnRH-agonist to the substituted cycle in FET treatment reduces the early pregnancy loss.


Eligibility criteria: Inclusion Criteria:

* Endometrial thickness ≥ 7 mm after stimulation
* 18-45 years
* IVF/ICSI fertilisation
* BMI \> 18,5 \<30 kg/m2
* cycle length 25-34 days

Exclusion Criteria:

* endometrial thickness \< 7 mm or no triple layer endometrium and/or functional follicles
* Uterine abnormality
* Chronic medical disease
* oocyte donation cycles

Primary outcomes:
measure: Pregnancy loss rate
timeFrame: Primary outcome is avaible after 12th week of gestational.
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 14 days after embryo transfer.
Other outcomes:
measure: Luteal progesterone levels
timeFrame: 7th week of gestation
Locations:
city: Fredericia
country: Denmark
facility: IVF syd
city: Skive
country: Denmark
facility: Fertility Clinic Regional Hospital Skive
Study officials:
affiliation: Fertility Clinic Regional Hospital Skive
name: Birgit Alsbjerg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000312: Alterations in Serotonergic Functions in Cocaine Addicts - 1
Official title: Alterations in Serotonergic Functions in Cocaine Addicts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: US Department of Veterans Affairs
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate alterations in the serotonergic system in cocaine addicts and attempt to dissociate changes secondary to cocaine use from those associated with premorbid characteristics.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Side effects
measure: Neuroendocrine changes
measure: Psychological changes
measure: Craving
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: VA Medical Center
state: New York
Study officials:
affiliation: VA Medical Center
name: Laure Buydens-Branchey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biological Psychiatry (in press) The. AM. Int. on Addictions (in press)
Clinical trial NCT03434912: Identification and Evaluation of Circulating Tumor Cells and Tumor Related Rare Cells in Immunotherapy
Official title: Identification and Evaluation of the Potential Biomarkers on Circulating Tumor Cells and Tumor Related Rare Cells in Cancer Patients Undergoing Immunotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CTC and Tumor Related Rare Cell
Lead sponsor: MiCareo Taiwan Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2018-02-15
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 80 cancer patients undergoing immunotherapy

Brief summary: The primary objective of this study is designed to evaluate the enumeration of circulating tumor cells and identify the potential biomarkers associated with clinical outcome. The secondary objective is to explore whether the changes of tumor related rare cells associates clinical outcome.


Eligibility criteria: Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
2. Over 20 years of age.
3. Cancer patients on immune checkpoint inhibitors.

Exclusion Criteria:

1. Subjects who have other cancer history
2. Pregnant females
3. Subjects with active, known or suspected autoimmune disease.
4. Known history of human immunodeficiency virus (HIV)

Primary outcomes:
measure: Circulating tumor cell
timeFrame: 1 years
Secondary outcomes:
measure: tumor related rare cell
timeFrame: 1 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: