louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01423786: Early Oral Nutrition in Mild Acute Pediatric Pancreatitis
Official title: Early Oral Nutrition in Mild Acute Pediatric Pancreatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Pediatric Pancreatitis
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 34
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective trial for children with the diagnosis of mild acute pancreatitis admitted to the hospital for continued management. Patients will be enrolled in the study within 24 hours of admission/diagnosis and will be allowed an oral diet once enrolled. Demographic, laboratory and imaging data done as standard of care will be collected and additional blood work will be sent as part of the study. Patients will be followed prospectively with regards to tolerance to oral nutrition, pain, length of stay and complications. The hypothesis is that patients that are able to tolerate early oral nutrition will have shorter length of stays and will be similar in terms of pain score ratings, readmission rates, complications and the need for invasive supplemental nutrition. Also patients that are able to tolerate early oral nutrition will have less significant elevation of biochemical markers of pancreatitis severity when compared to patients that do not tolerate early oral nutrition and historical controls.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute pancreatitis
* Enroll within 24 hours of diagnosis
* At least 50% of baseline diet must be taken orally

Exclusion Criteria:

* Evidence of severe pancreatitis
* Diagnosis of chronic pancreatitis
* Patients unable to communicate pain or a desire to eat/drink

Primary outcomes:
measure: Tolerance of Oral Nutrition
timeFrame: 1 week
Secondary outcomes:
measure: Length of Stay
timeFrame: 1 week
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
citation: Ellery KM, Kumar S, Crandall W, Gariepy C. The Benefits of Early Oral Nutrition in Mild Acute Pancreatitis. J Pediatr. 2017 Dec;191:164-169. doi: 10.1016/j.jpeds.2017.08.032. Epub 2017 Oct 12.
Clinical trial NCT04162886: Effects of Exercises on Physical Performance
Official title: Effects of Thrower's Ten Exercises on Upper Extremity Strength, Power and Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Performance
Keywords: Exercise
power
muscle strength
balance
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: The aim of the study was to investigate the effects of thrower's ten exercises on the upper extremity performance in healthy sedentary individuals.

Method: 36 healthy sedentary men and women aged 18-35 years will be included in the study. Subjects will be divided into two groups: exercise and control. The exercise group will be given Thrower's Ten training sessions 3 times a week over an 8-week period. Before and after the study, the subjects were tested for dynamic balance on the upper extremity with the Upper Limp Y balance test and for explosive power with the medicine ball throw test. Moreover, the strength of the shoulder rotator muscles was measured with an isokinetic dynamometer at a speed of 60º/sec.


Eligibility criteria: Inclusion Criteria:

* Healthy women and men aged 18-35 years

Exclusion Criteria:

* Individuals with any neurological, orthopedic, cardiovascular, psychological problems,
* individuals who have a musculoskeletal injury in the last 1 year,
* individuals who doing regular physical activity/sport in the last 6 months

Primary outcomes:
measure: Change in the level of upper extremity strength assessed by an isokinetic dynamometer (Cybex Norm).
timeFrame: At the beginning and at the end of 8 weeks.
Secondary outcomes:
measure: Change in the level of upper extremity explosive strength assessed by a seated medicine ball throw (SMBT) test.
timeFrame: At the beginning and at the end of 8 weeks.
Other outcomes:
measure: Change in the level of upper extremity balance assessed using Upper Quarter Y Balance Test (UQYBT)
timeFrame: At the beginning and at the end of 8 weeks.
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
Study officials:
affiliation: Eastern Mediterranean University
name: Berkiye Kırmızıgil, Asst. Prof
role: STUDY_CHAIR
References:
citation: Gokalp O, Kirmizigil B. Effects of Thrower's Ten exercises on upper extremity performance: A randomized controlled study. Medicine (Baltimore). 2020 Oct 16;99(42):e22837. doi: 10.1097/MD.0000000000022837.
Clinical trial NCT01344486: Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions
Official title: Peritoneal Cavity Conditioning During Laparoscopic Surgery Decreases Postoperative Pain, Inflammatory Reaction and Postoperative Adhesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Endometriosis of the Cul-de-sac
Chocolate Cyst of Ovary
Fibroid/Myoma (Uterus/Cervix)
Keywords: women undergoing laparoscopic surgery
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 22
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Full conditioning of the peritoneal cavity during laparoscopic surgery will decrease post-operative pain, inflammation and adhesion formation.

Full conditioning will decrease an inflammatory response of the peritoneum and decrease pain and adhesion formation.

Detailed description: Randomized controlled trial (RCT) comparing carbon dioxide to full conditioning (addition of oxygen, nitrous oxide, humidification and temperature control, dexamethasone and Hyalobarrier gel) Women undergoing laparoscopy for endometriosis, myomectomy or adhesiolysis will be randomized to either group and will be compared for pain (VAS scores); inflammation (White blood cells, CRP) and adhesions scored by second look laparoscopy.

Eligibility criteria: Inclusion Criteria:

* women undergoing laparoscopic excision of deep endometriosis (stratum 1), excision of endometrioma's (stratum 2) or excision of uterine myoma's (stratum 3) since this is severe surgery, associated with severe postoperative adhesions and since for most of these women fertility is important and hence the second look laparoscopy can be beneficial.
* Signed informed consent

Exclusion Criteria:

* women with a pre-existing condition increasing the risk of surgery such as clotting disorders, heart or lung impairment etc.-Any condition that might interfere with inflammatory parameters such as immunodeficiency, chronic inflammatory disease as Crohn's disease.
* Pregnancy
* Conditions associated with chronic pain as peripheral neuropathy, pathology of the vertebral column and osteo-articular disease. Conditions causing acute pain e.g. abdominal trauma
* a known allergic reaction to Hyalobarrier Gel Endo®
* A bowel lesion requiring a single or double layer suture. (given that for none of the anti-adhesion barriers safety has been proven following bowel lesions and suture)

Primary outcomes:
measure: adhesion formation after laparoscopic surgery
timeFrame: 2 weeks after primary surgery
Secondary outcomes:
measure: Post-operative pain
timeFrame: recorded until 3 days after surgery
measure: inflammation
timeFrame: recorded until 3 days after surgery
measure: time to first flatus and stool
timeFrame: recorded until 3 days after surgery
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Philippe Koninckx, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006186: Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defects
Keywords: dilutional coagulopathy
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-08-28
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dilution of blood caused by cardiopulmonary bypass (the heart-lung machine) during open heart surgery is associated with decreased concentrations in the blood of coagulation factors. This can be extreme in infants because of their small blood volumes and can lead to impairment of the normal blood clotting mechanism and excessive bleeding after the operation. Transfusion of fresh whole blood has been shown to be an effective treatment because fresh blood is rich in coagulation factors. However, it is difficult to obtain truly fresh blood from a blood bank. We hypothesized that fresh blood drawn from the patient and given back after cardiopulmonary bypass would improve the clotting mechanism. In our study, the infants in the treatment group have some of their own fresh blood removed after they are anesthetized for the operation and before they are placed on cardiopulmonary bypass. This blood is then given back to them after completion of cardiopulmonary bypass. Infants in the control group will not have their own blood removed but will undergo cardiopulmonary bypass. We will compare the two groups by drawing blood samples that measure coagulation tests.


Eligibility criteria: Inclusion Criteria:

* Undergoing non-complex open heart surgery
* Diagnosis of congenital heart disease
* No previous open heart surgery
* Weight 15 kg or less

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Children's Hospital
state: Colorado
Study officials:
References:
Clinical trial NCT01406886: Combined Effects of Energy Density and Eating Rate on Appetite
Official title: Combined Effects of Energy Density and Eating Rate on Energy Intake and Biomarkers of Satiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite
Keywords: Modifiable environmental
behavioral factors
Lead sponsor: United States Army Research Institute of Environmental Medicine
Sponsor class: FED
First posted: 2011-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study will examine the independent and combined effects of energy density and eating rate on appetite and endocrine mediators of appetite. Increasing eating rate and energy intake are expected to additively increase energy intake.


Eligibility criteria: Inclusion Criteria:

* BMI 18-27 kg/m2
* Weight stable

Exclusion criteria:

* Chronic used of OTC or prescription drugs known to affect metabolism
* Chronic disease
* Gastric bypass surgery
* Disordered eating
* Pregnant or breastfeeding

Primary outcomes:
measure: Energy intake
timeFrame: 1 meal
Secondary outcomes:
measure: Subjective appetite
timeFrame: 0-180 min
measure: Postprandial peptide-YY response
timeFrame: 0-180 min
measure: Postprandial ghrelin response
timeFrame: 0-180 min
measure: Postprandial glucagon-like peptide-1 response
timeFrame: 0-180 min
measure: Postprandial pancreatic polypeptide response
timeFrame: 0-180 min
Other outcomes:
Locations:
city: Natick
country: United States
facility: USARIEM
state: Massachusetts
Study officials:
affiliation: US Army Research Institute of Environmental Medicine
name: Scott J Montain, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karl JP, Young AJ, Rood JC, Montain SJ. Independent and combined effects of eating rate and energy density on energy intake, appetite, and gut hormones. Obesity (Silver Spring). 2013 Mar;21(3):E244-52. doi: 10.1002/oby.20075.
Clinical trial NCT01050686: Need for Subcutaneous Wound Drains in Ileostomy Reversal
Official title: Need for Subcutaneous Wound Drains in Ileostomy Reversal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presence of Ileostomy
Keywords: ileostomy reversal
subcutaneous drain
hospital stay
postoperative wound infection
patients with elective ileostomy reversal
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether the insertion of subcutaneous wound drains has an influence on postoperative hospital stay in ileostomy reversal.


Eligibility criteria: Inclusion Criteria:

* elective open reversal of an protective ileostomy

Exclusion Criteria:

* age \< 18 years
* missing suitability to comprehend patient information

Primary outcomes:
measure: length of hospital stay (days)
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: surgical site infections
timeFrame: 3 months postoperatively
measure: colonization of abdominal wall with bacteria
timeFrame: 3 months postoperativly
measure: hematomas/ seromas
timeFrame: 3 months postoperatively
measure: postoperative complications
timeFrame: 3 months postoperatively
measure: postoperative pain/ dysaesthesia
timeFrame: 3 months postoperatively
measure: cosmetic result
timeFrame: 3 months postoperatively
measure: postoperative costs
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin; Hindenburgdamm 30
Study officials:
affiliation: Charite University, Berlin, Germany
name: Johannes C Lauscher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00164086: Atorvastatin in Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Myeloma
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2005-09-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the effects of a medication already widely used to treat cardiovascular disease and diabetes, in reducing the progression of myeloma.


Eligibility criteria: Inclusion Criteria:

* Myeloma in remission

Exclusion Criteria:

* Adverse events (AEs) to statin, already on a statin, or contraindication to statin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Andrew Spencer, MBChB, FRACP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03368586: Accuracy, Satisfaction and Usability of a FGM System Among Children and Adolescents Attending a Diabetes Summer Camp
Official title: Accuracy, Satisfaction and Usability of a Flash Glucose Monitoring System Among Children and Adolescents Attending a Diabetes Camp
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: Flash Glucose Monitoring
Children
Adolescents
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2017-12-11
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents, aged 6-18 years old, with type 1 diabetes mellitus, participating at the diabetes summer camp.

Brief summary: The aim of this study was to assess accuracy, satisfaction and usability of the FGM among children and adolescents with T1DM. The primary outcome was to assess the accuracy of the FGM system. Secondary outcomes included satisfaction and usability of the device as well as assessment of sensor-related issues.

Detailed description: The aim of this study was to assess the accuracy, satisfaction and usability of a Flash Glucose Monitoring system (FGM) in children and adolescents with type 1 diabetes mellitus (T1DM) and attending a 1-week diabetes summer camp, supervised by a multidisciplinary team of health care providers. The camp comprised a structured daily routine with five fixed meals: breakfast, lunch, afternoon snack, dinner and evening snack. Capillary blood glucose (BG) values were measured in parallel with unmasked Flash Glucose measurements (FGM) using the FGM reader's built-in glucometer at breakfast, lunch and dinner. Additional measurements were taken before snacks, between the meals or overnight and BG was measured only in cases of low (\<4.0 mmol/L) or high (\>15.0 mmol/L) FGM values or when symptoms were discordant with sensor readings. Sensor-related issues were documented and a questionnaire assessing satisfaction and usability of the FGM was completed by patients and caregivers at study completion.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus, children and adolescents participating at the diabetes summer camp.

Exclusion Criteria:

* Acute health condition (infectious disease), known allergy to medical adhesives or with a skin condition (e.g. atopic dermatitis)).

Primary outcomes:
measure: FGM accuracy
timeFrame: through study completion, 1 week
Secondary outcomes:
measure: Participants satisfaction with the FGM system
timeFrame: At last camp day
measure: Caregivers satisfaction with the FGM system
timeFrame: At last camp day
measure: Sensor related-issues
timeFrame: Through study completion, 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Lausanne University Hospitals
name: Michael Hauschild, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00802386: Bacterial Vaginosis Screening at IUD Insertion
Official title: Screening for Bacterial Vaginosis Screening at IUD Insertion: Is There a Role?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BACTERIAL VAGINOSIS
Keywords: BACTERIAL VAGINOSIS
IUD INSERTION
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2008-12-04
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women between the ages of 18 and 48, who request to have an IUD inserted, both for contraceptive and noncontraceptive indications, will be asked to participate in the study.

Brief summary: A number of studies have shown a higher prevalence of BV among IUD users.13,,14 None, however, have screened women prior to inserting the IUD. No data exists detailing the status of the vaginal microflora and possible cervical infection prior to IUD insertion. Thus, no inference can be made about the possible influence of IUD insertion and presence to the development of upper genital tract infection . Consequently, with the current literature, it would be difficult to make an argument for screening and treatment for BV prior to IUD insertion. This study will help us determine whether women with an IUD develop a change in the normal bacteria that are present in the vagina, known as bacterial vaginosis (BV). In addition, in those women with BV, we are looking to see if they develop more significant problems with the IUD, than those who do not have BV. Overall, this will help us determine whether all women should be screened for BV prior to IUD insertion.


Eligibility criteria: Inclusion Criteria:

* Women between the ages of 18 and 48, who request to have an IUD inserted, both for contraceptive and noncontraceptive indications, will be asked to participate in the study.

Exclusion Criteria:

* pregnancy
* a previous history of ectopic pregnancy or pelvic inflammatory disease
* HIV positive or immunocompromised
* unable to understand English
* unable to give informed consent

Primary outcomes:
measure: Rate of abnormal bleeding
timeFrame: 1 month
measure: Pain/cramping
timeFrame: 1 month
measure: Expulsion
timeFrame: 1 month
measure: Pelvic infection
timeFrame: 1 month
Secondary outcomes:
measure: Occurence of new onset BV infection
timeFrame: 1 month post-IUD insertion
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT00158886: Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer
Official title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Carcinoma, Renal Cell
Keywords: oral topotecan rectal cancer pelvic radiation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with rectal cancer who are candidates for pre-operative radiation therapy may be enrolled in the Phase I, single center study. Patients will have a full blood count, biochemistry, urinalysis, and ECG for safety evaluation. Sequential cohorts of three patients will be given increasing doses of oral topotecan and fixed doses of concurrent radiation (45 Gy) over five weeks. The starting dose of oral topotecan is 0.25 mg/m2 to be concomitantly administered with radiation (45 Gy) x 5 days every week unless the radiation is interrupted for Holidays/Weekends or toxicity requiring treatment delays occurs. A total of 25 doses are planned.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed rectal cancer.
* Candidates for preoperative radiotherapy.
* Primary tumor at least 3cm and clinical stage of T2, T3, or T4 and any N according to the Astler-Coller modification of the Dukes staging system.
* Eastern Cooperative Oncology Group (ECOG) performance status less than 2.
* Diagnosis of rectal cancer should be no more than 90 days from start of therapy.
* Evaluation at the H. Lee Moffitt Cancer Center.
* Recovery from prior surgery and life expectancy at least 3 months.

Exclusion Criteria:

* A primary tumor totally excised.
* Recurrent rectal cancer that failed initial treatment.
* Exposure to topotecan, infection, immunodeficiencies, conditions of the gastrointestinal (GI) tract which would affect absorption, medication that maintains motility/gastric emptying.
* Any concomitant malignancy within the last five years.
* Severe medical problems unrelated to the malignancy which would limit compliance with the study.
* Patients of child bearing potential.
* Not practicing adequate contraception.
* Patients who are pregnant or lactating.
* Use of an investigational drug within 30 days or 5 half-lives of the first dose.

Primary outcomes:
measure: To determine the MTD of oral topotecan in combination with pelvic radiation
timeFrame: Up to 24 months
Secondary outcomes:
measure: To evaluate the toxicity and potential efficacy of oral topotecan and concurrent pelvic radiation for the treatment of rectal cancer. To determine pathologic response to treatment and assessment of sphincter preservation.
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: