louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00855556: Parkinson's Disease Genetics Database
Official title: Parkinson's Disease Genetics Database
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parkinson's Disease
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2009-03-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a diagnosis of Parkinson's Disease as determined by standard neurological criteria.

Brief summary: The goal of the study is to develop and organize an effort to identify genes that determine an individual's risk for developing Parkinson's disease (PD).

1. To ascertain, study and establish a repository of DNA samples that will allow for the identification of known and yet-to-be-identified genetic markers associated with the development of PD.
2. To create a database with clinical, genetic (HLA, genome screen) and medical history information that will facilitate the search for PD susceptibility genes.
3. To provide a centralized DNA repository to allow for targeted studies of genetic factors contributing to the onset, heterogeneity and progression of PD.
4. To evaluate opportunities to extend the results of research to develop methods of risk prediction, prevention and therapy for PD.


Eligibility criteria: Inclusion Criteria:

* Subjects must have a diagnosis of Parkinson's Disease as determined by standard neurological criteria.
* Patients ≥18 years of age who are able to provide informed consent
* Patients ≥ 18 who are decisionally impaired for whom informed consent can be obtained by a legally authorized representative.

Exclusion Criteria:

* Patients without a diagnosis of Parkinson's Disease.

Primary outcomes:
measure: the current protocol is for establishment of the registry only and not for particular analyses of its contents
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
Study officials:
affiliation: Northwell Health
name: Michael Pourfar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01450956: The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery
Official title: The Protective Effects of Sevoflurane Application During CPB on Pediatric Patients Underwent Cardiac Surgery: a Randomized, Controlled, Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Diseases
Keywords: congenital heart diseases
cardiopulmonary bypass
Pediatric
sevoflurane
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-10-13
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During repair of a congenital heart defect the child is exposed to myocardial hypoxia. Recent studies have suggested that the paediatric myocardium is more sensitive to hypoxia and cardioplegic arrest than the adult. The protective effect of halogenated agents on ischaemia and reperfusion injury has been investigated widely in adults. The investigators hypothesis that sevoflurane applied during cardiopulmonary bypass might afford better myocardial protection during paediatric cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* pediatric patients (body weight \< 10 kg)
* diagnosed with congenital heart diseases
* scheduled for repair operation with CPB
* in the Department of Cardiovascular Surgery, Xijing Hospital

Exclusion Criteria:

* systemic infections
* other systemic diseases

Primary outcomes:
measure: all cause mortality
timeFrame: within the first 30 days (plus or minus 3 days) after surgery
Secondary outcomes:
measure: serum cTnI concentrations
timeFrame: 48 h after the surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Cardiovascular Surgery, Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Department of Cardiovascular Surgery, Xijing Hospital
name: Zhenxiao Jin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xiong HY, Liu Y, Shu DC, Zhang SL, Qian X, Duan WX, Cheng L, Yu SQ, Jin ZX. Effects of Sevoflurane Inhalation During Cardiopulmonary Bypass on Pediatric Patients: A Randomized Controlled Clinical Trial. ASAIO J. 2016 Jan-Feb;62(1):63-8. doi: 10.1097/MAT.0000000000000285.
Clinical trial NCT04754256: Causes of Appetite Loss in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Causes of Appetite Loss in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 87
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients found in Danish Facebook support group

Brief summary: The project looks at causes of appetite loss in patients with COPD. It is know that active systemic inflammation can lead to appetite loss and COPD is classified as a disease lead by inflammation. But it has never been investigated if the patient with COPD has other causes of appetite loss such as physical, psychological or social barriers for not reaching a sufficient dietary intake.

The study uses a homemade questionnaire, the CAT-scale and the CNAQ-score to evaluate the extent of appetite loss and certain demographic characteristics of the participants. There will be made correlation analysis for CNAQ-score and continuous variables and there will be tested for significant differences between the group who scores as low appetite and the group that scores with a normal appetite via CNAQ.

The second part of the study invites patients to participate in a semi-structured interview, that focuses on the patient's experience with appetite loss, meals and food. The interviews will be transcribed and analysed.


Eligibility criteria: Inclusion Criteria:

* COPD diagnosis

Exclusion Criteria:

* None

Primary outcomes:
measure: CNAQ-score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
References:
Clinical trial NCT05020756: Study in Children Who Have Switched to Isosource Junior Mix Formula
Official title: A Retrospective Study in Children Who Have Switched to Isosource Junior Mix Formula (RICIMIX Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Great Ormond Street Hospital for Children NHS Foundation Trust
First posted: 2021-08-25
Enrollment: 43
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paediatric children \> 12 months of age who require Isosource Junior Mix as an enteral tube feeding formula and have consumed the formula for at least 1 month

Brief summary: A Retrospective study In Children who have switched to Isosource Junior Mix formula (RICIMIX study) will review paediatric children \> 12 months of age who require Isosource Junior Mix as an enteral tube feeding formula and have consumed the formula for at least 1 month. The purpose of this study is to understand If there has been an improvement in outcomes/ experiences

* The current usage of ISJMIX formula in children who require blended diets
* Improved feeding intolerances
* Improved patient outcomes/ experiences

Detailed description: Retrospective data will be collected using questionnaire by the dietitians at the nutrition and dietetic department. All completed questionnaires will be sent back to Nestle Health Science/ CRO company.

The primary objectives:

The following measures will be collected retrospectively after 1 month use of ISJMIX

* Feeding tolerance \[no change, tolerance improved, tolerance worsened\]: gastric residuals, gagging/retching, vomiting, abdominal distention/ gas, stool consistency issues (too hard, too loose)
* Volume of formula consumed in a day

The secondary objective is to collect restropective data on:

* Any improved patient outcomes noted
* Calculate the potential cost savings made when using ISJMIX to help manage the feeding intolerances
* Calculate the potential costs benefit of using ISJMIX over other standard formulas

Eligibility criteria: Inclusion Criteria:

* All children who are using Isosource Junior Mix as tube feed formula

Exclusion Criteria:

* All children who did not switch to Isosource Junior Mix feed formula

Primary outcomes:
measure: Feeding tolerance
timeFrame: 30 days
Secondary outcomes:
measure: Volume consumed
timeFrame: 30 days
measure: Weight in Kg
timeFrame: 1 month
Other outcomes:
Locations:
city: Gatwick
country: United Kingdom
facility: Nestle Health Science
Study officials:
References:
Clinical trial NCT02838056: Early Detection of Epidural Onset by Temperature Change
Official title: Early Detection of the Effect of Epidural Local Anesthetic by Temperature Change on the Big Toe
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Confirmation of Epidural Catheterization
Keywords: anesthesia, epidural
skin temperature
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Traditionally, placement of the epidural catheter is based on hand feel of passing through the ligamentum flavum as well as "loss of resistance" while injecting the air through the needle. However, both are subjective and not necessarily encountered consistently. Moreover, the onset of sensory block is usually slow, thus making confirmation of catheter position a tough task and may delay the turnover of the operating room. The only way to confirm the catheter position objectively without delaying surgery is to find a reliable indicator within minutes of local anesthetic injection. In this study, we try to use the change of temperature in the big toe as a surrogate indicator of correct epidural catheterization.

Detailed description: Epidural anesthesia loading dose: 17ml 2% xylocaine + 2.3ml sodium bicarbonate + 2ml Rapifen (1088 mcg) + 0.1 mg epinephrine

Eligibility criteria: Inclusion Criteria:

* Body weight:50-90kg,
* American Society of Anesthesiologists physical status classification I-II,
* Under epidural anesthesia for surgery

Exclusion Criteria:

* History of receiving lumbar surgery
* Allergy to alfentanil ,xylocaine, bicarbonate
* Trauma

Primary outcomes:
measure: measurement of skin temperature change over big toe after epidural local anesthetic injection
timeFrame: within 10 mins after injection
Secondary outcomes:
measure: measurement of skin sensation change between inguinal area to umbilicus
timeFrame: within 15 mins after injection
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University/Wan Fang Hospital
Study officials:
affiliation: Taipei Medical University/Wan Fang Hospital
name: Jui-An Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cherng CH, Wong CS, Ho ST. Epidural fentanyl speeds the onset of sensory block during epidural lidocaine anesthesia. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):523-6. doi: 10.1053/rapm.2001.27852.
citation: Werdehausen R, Braun S, Hermanns H, Freynhagen R, Lipfert P, Stevens MF. Uniform distribution of skin-temperature increase after different regional-anesthesia techniques of the lower extremity. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):73-8. doi: 10.1016/j.rapm.2006.07.009.
citation: Coda BA, Brown MC, Schaffer R, Donaldson G, Jacobson R, Hautman B, Shen DD. Pharmacology of epidural fentanyl, alfentanil, and sufentanil in volunteers. Anesthesiology. 1994 Nov;81(5):1149-61. doi: 10.1097/00000542-199411000-00008.
Clinical trial NCT03047356: Sleep Intervention
Official title: Effects of "If-then" Plans ("Implementation Intentions") on Adolescent Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 151
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A trial that tests whether implementation intentions improve sleep among adoelescents.


Eligibility criteria: Inclusion Criteria:

* Aged 12-16 years

Exclusion Criteria:

* Unable or unwilling to complete the question

Primary outcomes:
measure: Achieving recommended sleep levels
timeFrame: 1 month
Secondary outcomes:
measure: Self-regulation
timeFrame: 1 month
measure: Habit
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00639756: The Effect of Allopurinol on Insulin Resistance and Blood Pressure
Official title: Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolic Syndrome
Keywords: Uric acid
Fructose
Hypertension
Insulin
Glucose
HOMA
Lead sponsor: Hospital Mateo Orfila
Sponsor class: OTHER
First posted: 2008-03-20
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Studies in animals have found that allopurinol can markedly improve fructose induced metabolic syndrome. In this study we test the hypothesis that allopurinol may lower BP, reduce triglycerides, and improve metabolic parameters in subjects placed on a high fructose diet.

Detailed description: 60 male subjects, age 40 to 65 years of age, will be placed on a 3500kcal (55% carbohydrates containing 200 g fructose) for 2 weeks. Half will receive allopurinol mg/day (randomized). At the end of 2 weeks we measure a variety of parameters including fasting glucose and insulin levels (with calculation of HOMA index), serum lipids (including triglycerides and LDL/HDL cholesterol), sitting blood pressure, serum uric acid, weight, and various other measurements (C reactive protein, adiponectin and leptin levels, and urate redox products). Primary endpoint is insulin resistance. Secondary endpoints are blood pressure, lipids, uric acid, weight.

Eligibility criteria: Inclusion Criteria:

* Males, age 40 -65 yrs

Exclusion Criteria:

* None

Primary outcomes:
measure: Insulin resistance (HOMA index)
timeFrame: 2 weeks
measure: Blood pressure
timeFrame: 2 weeks
measure: Triglycerides, HDL cholesterol
timeFrame: 2 weeks
Secondary outcomes:
measure: Adiponectin
timeFrame: 2 weeks
measure: Leptin
timeFrame: 2 weeks
measure: CRP level
timeFrame: 2 weeks
measure: Weight gain
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Menorca
country: Spain
facility: Renal Unit, Mateo Orfila Hospital
state: Balearic Islands
Study officials:
References:
citation: Johnson RJ, Perez-Pozo SE, Lillo JL, Grases F, Schold JD, Kuwabara M, Sato Y, Hernando AA, Garcia G, Jensen T, Rivard C, Sanchez-Lozada LG, Roncal C, Lanaspa MA. Fructose increases risk for kidney stones: potential role in metabolic syndrome and heat stress. BMC Nephrol. 2018 Nov 8;19(1):315. doi: 10.1186/s12882-018-1105-0.
citation: Perez-Pozo SE, Schold J, Nakagawa T, Sanchez-Lozada LG, Johnson RJ, Lillo JL. Excessive fructose intake induces the features of metabolic syndrome in healthy adult men: role of uric acid in the hypertensive response. Int J Obes (Lond). 2010 Mar;34(3):454-61. doi: 10.1038/ijo.2009.259. Epub 2009 Dec 22.
Clinical trial NCT03681756: WALK Study: Women's Active Living for Koreans Study
Official title: Development of a Lifestyle Intervention for Korean American Women at Risk for Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Metabolic Syndrome
Lifestyle, Sedentary
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The prevalence of metabolic syndrome (MetS) is a health concern among Asians. Growing evidence indicates that Korean Americans had higher MetS prevalence compared to non-Hispanic Whites, but a culturally and linguistically appropriate lifestyle intervention has not been developed for Korean American middle-aged and older women. Thus, the investigators propose to develop a 4-week lifestyle intervention (Women's Active Living for Koreans (WALK) Study) to increase physical activity (PA) and reduce sedentary behavior for Korean American women.

Detailed description: The purpose of this pilot study is to develop a 4-week lifestyle intervention (Women's Active Living for Koreans (WALK) Study) to increase physical activity (PA) and reduce sedentary behavior for Korean American women. The investigators will assess feasibility and acceptability of the WALK Study and potential efficacy of the WALK Study on outcomes including sedentary behavior and PA.

Eligibility criteria: Inclusion Criteria:

* Self-identified Korean-speaking Korean American women
* Sedentary lifestyle at work and/or during leisure time
* Aged between 40 and 69; 4) intention to be physically active
* KakaoTalk user

Exclusion Criteria

* Medical conditions or physical problems requiring a special care exercise program
* Known bone or join problems that impair the ability to do moderate physical activity
* Participating in a lifestyle modification program or research study
* Planning a trip out of the U.S. during the next 2 months
* Pregnancy.

Primary outcomes:
measure: Physical activity
timeFrame: Last 7 days
Secondary outcomes:
measure: Sedentary behavior
timeFrame: Last 7 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ji Won Choi, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05505656: Accuracy of Endomyometrial Biopsy in Diagnosis of Adenomyosis
Official title: Accuracy of Endomyometrial Biopsy in Diagnosis of Adenomyosis. A Prospective Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenomyosis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with abnormal uterine bleeding as diagnosed by ultrasound and mri

Brief summary: This study will compare the accuracy of diagnosing adenomyosis by obtaining hysteroscopic guided endomyometrial biopsy and comparing it to accuracy of diagnosis by transvaginal ultrasound and magnetic resonance imaging.

Detailed description: Preoperative diagnosis of adenomyosis is usually difficult. The use of ultrasound and MRI for preoperative diagnosis is still of low positive predictive values. The majority of cases of adenomyosis are diagnosed postoperatively after justo pathological examination of the hysterectomy specimens.

The introduction of the concept of preoperative diagnosis of adenomyosis through a hysteroscopic endomyometrial biopsies may be a very good method for preoperative diagnosis of this condition. Participants patients who are diagnosed as adenomyosis by Ultrasound and MRI and scheduled for hysterectomy will undergo an endomyometrial biopsy. The accuracy of this method, its sensitivity, specificity, positive and negative predictive values of this method will be compared with the conventional methods for preoperative diagnosis of adenomyosis after final diagnosis by final gusto pathological diagnosis of hysterectomy specimens.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with abnormal uterine bleeding due to adenomyosis diagnosed by transvaginal ultrasound and mri and scheduled for hysterectomy

Exclusion Criteria:

* hysterectomy not performed
* incomplete ultrasound and mri information

Primary outcomes:
measure: To compare endomyometrial biopsy with postoperative pathology to calculate Accuracy and likelihood ratio of endomyometrial biopsy to diagnose adenomyosis .
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Sensitivity, specificity, positive and negative predictive values of endomyometrial biopsy for diagnosis of adenomyosis compared to US and MRI
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Professor of Obstetrics and Gynecology
name: Mohamed Laban
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05842356: Parental Feelings About Their Child Needing a Central Line
Official title: Parental Feelings About Their Child Needing a Central Line
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Children, Only
Stress
Keywords: Central Venous Line (CVL)
Peripherally Inserted Central Catheter (PICC)
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this research project is to determine if different communication techniques during the consent process impact parental anxiety and comfort providing consent.

Detailed description: The parents of children in the pediatric intensive care units (PICUs) at Columbia University may be asked if they are interested in participating in this study if their child needs a central venous line (CVL) or peripherally inserted central catheter (PICC) placed.

If the parents are interested in participating, they will be randomly assigned to a communication technique group while they are discussing the procedure and giving consent with a medical team member. After they provide consent, they will be asked to complete surveys about their thoughts and feelings. The study should take about 15 minutes.

After data is collected, the researchers will compare survey answers between the two communication styles used with parents.

Eligibility criteria: Inclusion Criteria:

* Parent or guardian of a child admitted to the pediatric intensive care units (PICUs) at Columbia University
* The child needs a central venous line (CVL) or peripherally inserted central catheter (PICC) placed in the PICU
* The parent or guardian speaks English or Spanish

Exclusion Criteria:

* Parents or guardians who speak languages other than English or Spanish
* Parents or guardians of children who need a CVL or PICC placed during an emergency without consent
* Parents or guardians who are unable to be physically present and provide consent over the phone

Primary outcomes:
measure: Parental Anxiety
timeFrame: 15 minutes
measure: Parental Comfort Providing Consent
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University New York-Presbyterian Morgan Stanley Children's Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Jeffrey Edwards, MD, MA, MS
role: PRINCIPAL_INVESTIGATOR
References: