louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02146287: Preterm Infants: Light Effects on Health and Development
Official title: Preterm Infants: Light Effects on Health and Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant Health
Preterm Infant Development
Keywords: cycled light
preterm infants
infant neurodevelopment
infant sleep
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2014-05-23
Enrollment: 121
Sex: ALL
Minimum age (years): 23
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preterm babies cared for in the intensive care nursery are exposed to amounts of light that are very different from the exposures to an unborn baby or the newborn term baby. Currently many nurseries try to protect premature babies from too much light. They may also try to create light conditions of day and night like many parent homes. Some studies have shown improvements in health and development of babies cared for in nurseries that try to change light for premature babies.


Eligibility criteria: Inclusion Criteria:

* Infants were \< 7 days of age and were born at 28 weeks or \< 28 weeks

Exclusion Criteria:

* known anomalies associated with neurological or visual problems (e.g., congenital glaucoma, Down Syndrome)

Primary outcomes:
measure: Infant weight gain trajectory
timeFrame: weekly inpatient up to 52 weeks post menstral age (PMA) and at outpatient visits to 18 months
measure: Change in sleep development during hospitalization
timeFrame: Every three weeks up to 52 weeks PMA
measure: Change in sleep development after discharge home
timeFrame: Every 5 months following hospital discharge up to 24 months PMA
measure: Mental Development
timeFrame: 9 months PMA
measure: Psychomotor Development
timeFrame: 9 months PMA
measure: Mental Development
timeFrame: 18 months PMA
measure: Psychomotor Development
timeFrame: 18 months PMA
Secondary outcomes:
measure: Length of Hospitalization in Days
timeFrame: At hospital discharge from 0 to 222 days
measure: Severity of Retinopathy of Prematurity (ROP)
timeFrame: Up to 52 weeks
measure: visual acuity
timeFrame: Measures at 12 months PMA
measure: Neurological development
timeFrame: 9 months PMA
measure: Brainstorm Auditory Evoked Potentials
timeFrame: 6 months
measure: Neurological development
timeFrame: 18 months PMA
measure: Change in Retinopathy of Prematurity (ROP)
timeFrame: Every two weeks during hospitalization after 30 weeks PMA up to 52 weeks PMA and during outpatient visits up to 24 months PMA
Other outcomes:
Locations:
Study officials:
affiliation: Duke University School of Nursing
name: Debra H Brandon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park J, Knafl G, Thoyre S, Brandon D. Factors associated with feeding progression in extremely preterm infants. Nurs Res. 2015 May-Jun;64(3):159-67. doi: 10.1097/NNR.0000000000000093.
Clinical trial NCT02557087: Hyoscine ButylBromide for Intrapartum Analgesia
Official title: Efficacy of Intravenous Hyoscine ButylBromide as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Analgesia, Obstetrical
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 104
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess whether hyoscine butylbromide is as effective as pethidine for analgesia during the first stage of labor.


Eligibility criteria: Inclusion Criteria:

* Primiparity
* Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes)
* Maternal age between 20-30 years
* Singleton term pregnancy (37-42 weeks of gestation)
* Vertex-presenting fetus

Exclusion Criteria:

* Clinical evidence of cephalopelvic disproportion.
* Scarred uterus; previous cesarean section, hysterotomy or myomectomy.
* Any medical disorders associated with pregnancy.
* Fetal distress
* Receiving any regional or parenteral analgesia before recruitment in the study
* Known hypersensitivity to the drug family

Primary outcomes:
measure: The efficacy of intravenous tenoxicam to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale.
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02580487: Perioperative Pain Management of Pediatric Appendectomy Patients
Official title: Perioperative Pain Management of Pediatric Appendectomy Patients in Kuopio University Hospital During the Years 2010-2012
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis
Keywords: acute appendicitis
pain management
analgesics
pediatric patients
laparoscopy
open surgery
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 178
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: 152 pediatric patients that were operated on in KUH during the years 2010-2012 due to acute appendicitis.

In addition we assessed 26 pediatric appendectomy patients and their pain at rest, when coughing and when compressing the wound area propsectively when they were at hospital

Brief summary: Acute appendicitis is the most common illness that brings pediatric patients to the hospital for surgical treatment. Abdominal pain is the symptom because of which the patients go to the hospital. Some patients have severe pain and need analgesics before the final diagnosis and before surgery. After surgery most patient experience pain and at least 80 % of the patients need postoperative pain medication. For two decades there has been a clinical guideline for pain management in Kuopio University Hospital (KUH). The investigators aim was to evaluate how well the pain management for pediatric patient works in clinical practice.


Eligibility criteria: Inclusion Criteria:

* In prospective patients informed consent obtained
* Appendectomy performed

Exclusion Criteria:

* No informed consent

Primary outcomes:
measure: Pain
timeFrame: from preoperative evaluation until the patient left hospital maximum of 7 days
Secondary outcomes:
measure: amount of opioids used during hospital stay
timeFrame: from preoperative evaluation until the patient left hospital maximum of 7 days
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern savo
Study officials:
References:
Clinical trial NCT05302687: Probiotic Modulates Vaginal Microflora
Official title: Use of Probiotic to Modulate Vaginal Microflora and General Women's Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Microbial Colonization
Keywords: probiotics
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: International Islamic University Malaysia
First posted: 2022-03-31
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind randomized placebo-controlled trial design has been chosen. Randomization for the parallel prevention phase will be carried out after checking the inclusion and exclusion criteria.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects of oral administration of probiotic at 9 log colony forming unit (CFU)/day on vaginal microbiota profiles compared to placebo via the use of vaginal self-swab microbiota profiling.

Detailed description: 1. To evaluate differences in general women's health of women on probiotic and placebo via the use of questionnaire.
2. To evaluate differences in immunity of women on probiotic and placebo via blood immunity profiling.
3. To evaluate differences in gut microbiota profiles of women on probiotic and placebo via blood fecal microbiota profiling.

Eligibility criteria: Inclusion Criteria:

* Generally, healthy women aged 18-80. - Currently free from urogenital infections such as urinary tract infection (UTI), bacterial vaginosis (BV), or yeast vaginitis.
* Willing to commit throughout the experiment.

Exclusion Criteria:

* Pregnant.
* On vaginal suppository treatments within 4-weeks prior to entering the study.
* On oral medication for vaginal illnesses or any vaginal therapy such as hormones and estrogen within 4-weeks prior to entering the study.
* On long term medication (\> 6 months) for any illnesses.
* Have used vaginal estrogen cream, ring or tablet within 4-weeks prior to entering the study.
* Have used vaginal moisturizers, lubricants or homeopathic preparations within 4-weeks prior to entering the study.
* Have used spermicide agent within 4-weeks prior to entering the study.
* Pelvic or any gynecologic surgery 6-months prior to entering the study.

Primary outcomes:
measure: differences in general women's health
timeFrame: 12 weeks
measure: differences in immunity of women
timeFrame: 12 weeks
measure: differences in gut microbiota profiles of women
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: International Islamic University Malaysia
state: Selangor
Study officials:
affiliation: IIUM Kuantan Campus
name: Syahril Azizan Azha, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02567487: TAP Block With Two Different Doses of Levobupivacaine
Official title: Comparison of TAP Block With Two Different Doses of Levobupivacaine for Postoperative Pain Management in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the current study is to investigate the effects of two different doses of levobupivacaine in TAP (transversus abdominus plane) block for postoperative management. For this purpose we planned to include 50 children aged between 2 and 12 that will undergo unilateral inguinal surgery.

The doses that will be used in the study were within usual dose limits which is stated in prospectus of the study drug.

Detailed description: Fifty children undergoing TAP block were randomly divided into two groups as levobupivacaine 0.25% 0.5 ml/kg and levobupivacaine 0.25% 0.25 ml/kg. Postoperative pain was evaluated with observational pain scale and modified pediatric objective pain scale.

Eligibility criteria: Inclusion Criteria:

* Volunteers planned to undergo unilateral inguinal surgery under TAP (ilioinguinal and iliohypogastric block) and general anesthesia
* Aged between 2 and 12

Exclusion Criteria:

* Patients with coagulation dysfunction
* Patients with chronic pain
* Patients having infection at the site of intervention
* Patients with a history of allergy
* Patients having chronic diseases (hepatic dysfunction, renal failure)

Primary outcomes:
measure: postoperative VAS score <4 at postoperative 24 hours
timeFrame: Postoperative first 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University Medical Faculty
name: Neslihan Alkis
role: STUDY_DIRECTOR
References:
Clinical trial NCT00154687: Weekly TP-HDFL in the Treatment of Advanced TCC
Official title: A Phase II Study of Weekly Paclitaxel, Cisplatin and 24-Hour Infusion of High-Dose 5-Fluorouracil and Leucovorin(Weekly TP-HDFL) in the Treatment of Advanced Transitional Cell Carcinoma(TCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Transitional Cell Carcinoma
Keywords: Combination, Chemotherapy,transitional cell carcinoma
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of Weekly TP-HDFL in advanced transitional cell carcinoma in terms of response rate and overall survival.

Detailed description: Transitional cell carcinoma(TCC)of urothelium,including bladder, ureter, and renal pelvis TCCs, was the most lethal urology malignancy in Taiwan. In 1995, approximately 1,300 new cases of TCC was diagnosed in Taiwan and more than 600 patients died of this disease. Advanced TCC is a moderately chemosensitive disease. A combination of methotrexate, vinblastine, and cisplatin with or without doxorubicin (M-VAC or CMV) has been widely used since 1980s. Despite the response rate was as high as 40-70%, the survival of these patients was only slightly increased from a median of 7 to 9 months for those who were treated with supportive care or cisplatin alone to a median of 12 months by cisplatin-based combination chemotherapy. One of the reasons for the poor treatment results is the inevitable treatment-related toxicities related to conventional systemic chemotherapy.

Eligibility criteria: Inclusion Criteria:

1. Pathology proven TCC Recurrent or metastatic TCC Muscle-invasive TCC
2. Measurable disease
3. Age\>18
4. KPS\>60﹪
5. Creatinine clearance\>35ml/min,
6. AST/ALT \< or = 3.5times upper limits of normal reference values
7. Bilirubin\< or = 2.0 mg/dl
8. WBC \> or = 4,000/mm3, PLT \> or = 100,000/mm3
9. Written informed consent

Exclusion Criteria:

1. Previous systemic chemo is not allowed
2. TG \<70mg/dl
3. CNS metastasis
4. Life expectancy less than 3 months

Primary outcomes:
measure: response rate
timeFrame: 2000~2005
Secondary outcomes:
measure: Overall Survival ,Safety
timeFrame: 2000~2005
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Oncology, National Taiwan University Hospital
Study officials:
affiliation: Department of Oncology , National Taiwan University Hospital
name: Chih-Hung Hsu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oncology, National Taiwan University Hospital
name: Ann-Lii Cheng, M.D.,Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT02781987: Incidence and Risk Factor of Post-ERCP Pancreatitis in Chronic Pancreatitis
Official title: Changhai Hospital, the Second Military Medical University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-ERCP Acute Pancreatitis
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 2028
Sex: ALL
Minimum age (years): 5
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic pancreatitis patients underwent ERCP from January 2011 to May 2015 in Changhai Hospital.

Brief summary: The purpose of this study is to compare the incidence of post-ERCP pancreatitis (PEP) in chronic pancreatitis (CP) patients to that in biliary disease patients, to determine whether CP patients in early clinical stage have a higher PEP incidence, and to identify the predictive and protective factors for PEP in chronic pancreatitis patients.

Detailed description: Analysis of patients with chronic pancreatitis (CP group) and biliary disease (BD group) in Changhai Hospital from January 2011 to May 2015 were conducted. Difference of PEP incidences between BD group and CP group, as well as between M-ANNHEIM subcategories were calculated by chi-square test or Fisher's exact test. The predictive and protective factors for PEP were investigated by univariate and multivariate analysis.

Eligibility criteria: Inclusion Criteria:

* patients with an endoscope inserted to cannulate the pancreatic/biliary duct were included.

Exclusion Criteria:

* patients in whom the papilla of Vater was not reached;
* patients who underwent stent removal procedures without ductal cannulation;
* patients in whom the intubation was failed.

Primary outcomes:
measure: Numbers of chronic pancreatitis patients with post-ERCP pancreatitis, diabetes mellitus, steatorrhea, previous pancreatitis, previous PEP, pancreatic divisum, jaundice, ESWL, pancreatic duct stone, drainage and minor papilla pancreatogram.
timeFrame: 8 months
Secondary outcomes:
measure: Numbers of biliary disease patients with post-ERCP pancreatitis, previous pancreatitis and previous PEP.
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Changhai Hospital
name: Zhao-shen Li
role: STUDY_CHAIR
References:
citation: Zhao ZH, Hu LH, Ren HB, Zhao AJ, Qian YY, Sun XT, Su S, Zhu SG, Yu J, Zou WB, Guo XR, Wang L, Li ZS, Liao Z. Incidence and risk factors for post-ERCP pancreatitis in chronic pancreatitis. Gastrointest Endosc. 2017 Sep;86(3):519-524.e1. doi: 10.1016/j.gie.2016.12.020. Epub 2017 Jan 4.
Clinical trial NCT04548687: a Randomized Clinical Trial Evaluating the Effectiveness of Carbon Dioxide Use in Cardiac Surgery
Official title: Pilot Prospective Randomized Clinical Trial "Insufflation of Carbon Dioxide During Minimally Invasive and Repeated Cardiac Surgery"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carbon Dioxide
Keywords: carbon dioxide
cardiac surgery
delirium
minimally invasive intervention
redo cardiac surgery
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2020-09-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities.

Group 2: patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities, supplemented with carbon dioxide insufflation during surgery
Primary purpose: TREATMENT

Brief summary: study of the efficacy and safety of carbon dioxide in cardiac surgery: repeated or minimally invasive

Detailed description: prospective randomized clinical single-center study of the efficacy and safety of using carbon dioxide in deaeration of cardiac cavities during cardiac surgery (repeated interventions and minimally invasive interventions)

Eligibility criteria: Inclusion Criteria:

* Planned cardiac surgery on the left heart with limited deaeration: Minimally invasive approach (mininotomy, minimally invasive lateral thoracotomy); Re-intervention
* Signed informed voluntary consent

Exclusion Criteria:

* Patient refusal to participate in any stage of the study
* History of stroke, transient ischemic attack
* Hemodynamically significant stenosis of the brachiocephalic arteries (more than 70%)
* Swelling or thrombosis of the heart
* LV dysfunction (EF less than 30%)
* Atherosclerosis of the aorta (atheromatosis)
* Surgical access conversion

Primary outcomes:
measure: delirium: CAM-ICU, 3-D CAM
timeFrame: 7 days after surgery
Secondary outcomes:
measure: deaeration time
timeFrame: intraoperatively
measure: neurocognitive dysfunction
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: "E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation
Study officials:
affiliation: E.Meshalkin National medical research center
name: Alexander V. Bogachev-Prokophiev, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02861287: Economic Evaluation of the Use of Plerixafor for Autologous HSC Transplantation for Multiple Myeloma
Official title: Economic Evaluation of the Use of Plerixafor for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will retrospectively review 60 electronic health records of patients who underwent peripheral blood stem cell mobilization for Multiple Myeloma, and who failed to achieve efficient and clinically meaningful mobilization in response to a well-conducted "G-CSF alone" regimen.

Brief summary: This study aims to realize an economic evaluation of the introduction of Plerixafor in addition to G-CSF and alternative options, in patients with multiple myeloma (MM) who failed or insufficiently mobilize peripheral blood stem and progenitor cells in response to G-CSF alone.


Eligibility criteria: Inclusion Criteria:

* Adult patients diagnosed with Multiple Myeloma who were eligible for high-dose melphalan supported with autologous hematopoietic stem cell transplantation (HSCT) as part of their treatment plan
* First mobilization attempt
* "rhG-CSF alone" mobilization regimen
* Failed mobilization as documented by an increase in CD34+ cell mobilization deemed insufficient to initiate apheresis (below 15/µL), after the 4 first injections of rhG-CSF that are administered in the evening

Exclusion Criteria:

* Age \< 18 years;
* Primary diagnosis other than MM
* 2nd or subsequent mobilization attempt
* Patients who previously received HDCT + autologous HSCT
* Chemotherapy-based mobilization regimen
* Efficient mobilization, allowing for apheresis and collection of the target cell number (5x106 CD34+ cells/kg for every planned autologous transplantation as per institutional SOPs).

Primary outcomes:
measure: Cost-effectiveness analysis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du Rhône
Study officials:
affiliation: Institut Paoli-Calmettes
name: Christian Chabannon, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: