louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01096758: Follow-up of Adult Phenylketonuria (PKU) Patients
Official title: 5-year Follow-up of the Comparison of Life and Physical Health in Adult Patients With PKU and Healthy Age Matched Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Deficiencies
Phenylketonuria
Keywords: PKU
phenylketonuria
adult
patient
development
nutritional deficiencies
neurological outcome
psychological and neurological development
comparison with healthy adults
longitudinal development
quality of life
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2010-03-31
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult PKU patients who are or have been attending the Departements of Metabolic Diseases of the Klinikum der Universität München will be recruited for this study, if they had been participating already in the last study trial comparing adult PKU patients with healthy controls.

It will be attempted to include the same control persons as in the last study trial.

Brief summary: Adult patients with phenylketonuria (PKU) at the age around 40 years belong to the first patients generation with early treatment of the disease. PKU is caused by an inborn error of the amino acid metabolism and the so far best suitable therapy is an early and strict diet, which is low in phenylalanine.

Besides an early and continuously treatment in childhood, the nutritional and medical support during adolescence and adulthood have been suggested to influence the long-term physical health of adult PKU patients. As many adult PKU patients tend to neglect the necessarily strict diet, they do not get a balanced diet. For PKU patients some nutrients, which may be rare in an unbalanced diet, might help to improve health status, physical and neurological performance and quality of life.

Information about the longitudinal development of the patients status and the influence of the type of their medical care is not available. In this 5 year follow-up the investigators aim to study the quality of life and the medical, nutritional and psychological status of adult PKU patients, in whom corresponding information has already been collected previously.


Eligibility criteria: Inclusion Criteria:

* assured clinical diagnose of PKU or proof of mutation in the phenylalanine hydroxylase gene (for PKU patients only)
* both groups need to hand in a signed consent to participate in the study
* controls: have to be omnivores and should not be on drugs, which influence the lipid metabolism, during the last 3 months
* attendance of the last study trial

Exclusion Criteria:

* not fulfill the inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: Dr. von Hauner Childrens Hospital
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Berthold Koletzko, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03825458: Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.
Official title: Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 3500
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: Patients with hepatitis B infection (acute or chronic) or presenting with HBsAg loss (with/without anti-HBs seroconversion).

Brief summary: The " CirB-RNA " cohort aims to create a biological collection associated with clinical and biological data from patients with hepatitis B infection. This project is part of a much larger program that aims to characterize and quantify circulating viral RNAs as a possible new biomarker of hepatitis B functional cure.


Eligibility criteria: Inclusion Criteria:

* Adults patients and minor children over 6 years of age (in Lyon) with acute or chronic hepatitis B or presenting with HBsAg loss (with/without HBs seroconversion). (Co-infected patients with HDV and/or HCV and/or HIV are eligible)
* Patients requiring blood sampling for medical care at the time of the medical appointment.
* Informed patients who do not refuse to participate.
* Persons not affiliated to a social security scheme and persons receiving medical assistance from the state may be asked to participate in the study

Exclusion Criteria:

* Patients participating at the time of the inclusion to an interventional trial evaluating a drug likely to interfere with this study.
* Persons deprived of their liberty by a judicial or administrative decision
* Adults who are subject to a legal protection measure
* Children less than 6 years old (in Lyon)

Primary outcomes:
measure: Number of plot samples collected
timeFrame: maximum 46 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales
city: Lyon
country: France
facility: Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant
city: Milan
country: Italy
facility: Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Palermo
country: Italy
facility: Gastroenterology and Hepatology department - • Università degli Studi di Palermo
city: Parma
country: Italy
facility: Infectious diseases and hepatology unit - Azienda Ospedaliero
Study officials:
References:
Clinical trial NCT00960258: Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.
Official title: Phase I, Uncontrolled, Open-label, Non-randomized Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Advanced, Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: Solid Tumors
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-08-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg once daily administered orally as a single agent in Japanese patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Male or female Japanese patients \>/= 18 years
* Histologically or cytologically confirmed solid tumors
* ECOG-PS 0 - 1
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Uncontrolled hypertension
* Patients with severe renal impairment or on dialysis
* Patients with seizure disorder requiring anticonvulsant medication
* Known or suspected allergy to the investigational agent.

Primary outcomes:
measure: Grade 4 neutropenia for >/= 7 days, febrile neutropenia with Grade 4 neutropenia, Grade 4 thrombocytopenia, Grade 3 or 4 non-hematologic toxicity, hypertension and skin toxicity of Grade 3 or 4 which are not manageable and pharmacokinetics
timeFrame: After 5 weeks (after Cycle 1).
Secondary outcomes:
measure: Biomarker
timeFrame: At screening
measure: Response rate
timeFrame: Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
state: Chiba
city: Hidaka
country: Japan
state: Saitama
city: Chuo-ku
country: Japan
state: Tokyo
city: Mitaka
country: Japan
state: Tokyo
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05038358: Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms
Official title: Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms: a Patient-derived Tumoroids Prospective Collection From Systemic Treatment Naive Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Tumor
Colon Tumor
Keywords: Organoid collection from fresh human primary colonic tumor tissue
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 60
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: colorectal adenocarcinoma, naive from neo-adjuvant chemotherapy, indication of surgical resection

Brief summary: Colorectal cancer is the third most common cancer worldwide and its progression-free survival is still low, around 10 months. Thirthy to 50% of patients do not respond to chemotherapy upon initiation of treatment, suggesting that early development of chemoresistance mechanisms remains a major challenge. In order to better characterize these mechanisms, the aim is to develop a model of tumoroids derived from patients with a colorectal tumors prior to any systemic anti cancer treatment. This project will both allow us to study the role of the immunological microenvironment in chemoresistance and identify new predictive markers of tumor response. It will then serve to develop innovative personalized medicine strategies by targeting the newly identified mechanisms. This study should in fine help to improve the cancer patient's care.


Eligibility criteria: Inclusion Criteria:

* Male and female over 18 years old.
* Managed at the CHUGA for a colorectal adenocarcinoma
* With an indication for immediate surgical resection as part of the care.
* Patient naive from neo-adjuvant chemotherapy
* Patient did not object to the CRC-ORGA-2 study

Exclusion Criteria:

* Patients protected by law (pregnant or breastfeeding women, minors, patients under guardianship or trusteeship, persons deprived of their liberty or hospitalized under duress).
* Patients with positive HIV, HBV, HCV serology.

Primary outcomes:
measure: Percentage of viable organoids for 60 days of culture maintenance.
timeFrame: 60 days of culture maintenance.
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble Alpes
Study officials:
affiliation: university hospital of Grenoble alpes
name: GAEL ROTH, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01822158: Vaginal Delivery Debrief Checklist to Improve Team Communication
Official title: Vaginal Delivery Debrief: A Nursing Research Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Specified Complications of Labor and Delivery
Keywords: Vaginal Delivery
Debrief
Medical Team Communication
Obstetrical Safety
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is to determine if using a standardized debrief checklist after vaginal delivery improves communication between the vaginal delivery health care team members and if using the checklist increases a sense of enhanced communication between team members.

Detailed description: This is a study for providers who are a part of the health care team involved with vaginal delivery of newborns. A checklist has been developed that may improve communication between team members following birth. The goal of this study is to evaluate whether the checklist improves or enhances team member communication.

Eligibility criteria: Inclusion Criteria:

* Registered Nurses (RNs) and Licensed Practical Nurses (LPNs) in the Women's and Children's Services Department who attend vaginal deliveries as well as providers who attend vaginal deliveries at Providence St Peter Hospital Family Birth Center in Olympia Washington (WA).

Exclusion Criteria:

* None

Primary outcomes:
measure: Determine if there is a change in satisfaction with team communication following the use of a structured debrief checklist after vaginal deliveries.
timeFrame: Within 6 months of data collection
Secondary outcomes:
measure: Determine if the use of a vaginal delivery debrief checklist will reduce documentation of conflicting data in the electronic medical record.
timeFrame: Within 6 months of data collection
Other outcomes:
Locations:
city: Olympia
country: United States
facility: Providence St Peter Hospital 413 Lilly RD NE
state: Washington
Study officials:
affiliation: Providence Health & Services
name: Daren B Sachet, RN, BSN, MPA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01060358: Assessment of Spinal Stability
Official title: Neuromuscular Neutral Zones in Humans: A New Method to Assess Spinal Stability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine Stability
Low Back Pain
Keywords: lumbar spine
low back pain
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-02-02
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healty men and women between 21 and 45 years old with no history of low back pain of low back injury.

Brief summary: The purpose of this study is to verify the existence of neuromuscular neutral zones(NNZs) in humans, and develop non-invasive techniques to measure intervertebral kinematics of the lumbar spine. The results will be used to accurately quantify NNZs in humans, and provide a foundation for clinical trials on low back pain patients using this methodology.


Eligibility criteria: Inclusion Criteria:

* 21-45 years of age - typical working age in physically demanding jobs
* no history of low back injury or musculoskeletal disorder in the past one year
* any activity history: sedentary, active, or non-athletic, and 4) any ethnic background or race
* body mass index score less than 30

Exclusion Criteria:

* Younger than 21 or older than 45 years old (range not relevant to majority of physical labor force)
* previous injury, disorder, or illness related to the low back
* professional athletes
* professional workers engaged in physical labor (e.g., roofers, loaders/unloaders in warehouses, tile/concrete layers, etc.)
* pregnancy

Primary outcomes:
measure: neuromuscular neutral zones
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Bradley Davidson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Moshe Solomonow, Ph.D., M.D. (hon)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03618758: Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6
Official title: Safety and Efficacy of Intraperitoneal Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis Receiving Systemic Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer Stage IV
Peritoneal Carcinomatosis
Intraperitoneal Paclitaxel
mFOLFOX6
Keywords: Gastric cancer
Peritoneal carcinomatosis
Intraperitoneal chemotherapy
Paclitaxel
FOLFOX
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Boryung Pharmaceutical Co., Ltd
name: B. Braun Korea Co., Ltd.
First posted: 2018-08-07
Enrollment: 35
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: TREATMENT

Brief summary: Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy. Intraperitoneal chemotherapy in combination with systemic chemotherapy is under many clinical trials mainly in Japan, and are showing promising results.

This is Korea's first clinical trial on Intraperitoneal Paclitaxel with Systemic mFOLFOX6 chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Biopsy proven adenocarcinoma of gastric origin, primary or recurrent
* Identification of Peritoneal seeding by CT or diagnostic laparoscopy
* Patients confirmed to receive mFOLFOX6 on multidisciplinary outpatient clinic
* No previous history of chemotherapy or 4week after the last chemotherapy for gastric cancer
* Labs adequate for chemotherapy (within 2 weeks of enrollment)
* Absolute Neutrophil Count: ≧ 1,500/mm³
* Hemoglobin level: ≧ 8.0g/dL
* Platelet Count: ≧ 10×104/mm³
* AST (GOT), ALT (GPT): ≦ 100U/L
* Total Bilirubin: ≦ 2.0mg/dL
* Creatinine Clearance (CCl): ≧ 50mL/min
* ECOG 0 - 2
* Her-2 negative on endoscopic biopsy
* Age ≧ 20, \< 80
* Signed Informed consent form

Exclusion Criteria:

* Patients with other major medical disease or malignant tumors other than gastric cancer
* Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel
* Pregnant, breast-feeding women or with birth plan
* Patients refusing treatment

Primary outcomes:
measure: Dose determination (Phase 1)
timeFrame: 1 Year
measure: Overall survival (Phase 2)
timeFrame: 1 Year
Secondary outcomes:
measure: Progression-free survival
timeFrame: 1 Year
measure: Toxicity ratio
timeFrame: 3 Years
measure: Tumor response
timeFrame: 3 Years
measure: Conversion surgery ratio
timeFrame: 3 Years
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyung-Ho Kim, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04077658: Heartmath Migraine Study
Official title: A Pilot Single-center Randomized Controlled Study of the Effects of Smartphone Based Heart Rate Variability Biofeedback in People With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: HeartMath app
Inner Balance Sensor
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with intervention arm and waitlist control arm
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a two arm study comparing smartphone based heart rate variability biofeedback using the HeartMath app and InnerBalance sensor to waitlist control on migraine quality of life.

Detailed description: The primary objective of this study is to determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) compared to wait list control in migraine quality of life. Investigators will also look:

* To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in depression in people with migraine.
* To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in anxiety in people with migraine.
* To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in insomnia in people with migraine.

Eligibility criteria: Inclusion Criteria:

* International Classification of Headache Disorders (ICHD) 3 criteria for migraine
* 4-20 headache days/month
* Has not done behavioral therapy for migraine in the past year
* Has a smartphone and willing to try HRV biofeedback using an app and ear monitor
* English speaking
* HS graduate or higher level of education
* Patients must not make preventive medication changes for the course of the study. If patients just changed their preventive medication, they must wait a month before enrolling.

Exclusion Criteria:

* Doing any form of behavioral therapy for pain in the past year

Primary outcomes:
measure: To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) compared to wait list control in migraine quality of life
timeFrame: 8 Weeks
Secondary outcomes:
measure: Change in depression
timeFrame: 8 Weeks
measure: Change in anxiety
timeFrame: 8 Weeks
measure: Change insomnia
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Mia Minen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02703558: Evaluation of Fluorescein Use During Cystoscopy
Official title: Evaluation of Fluorescein Use During Cystoscopy, a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intraoperative Cystoscopy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is a prospective randomized controlled study. Female patients over 18 years of age, who present for treatment of pelvic organ prolapse and/or stress urinary incontinence at the Pelvic Floor Center at the Johns Hopkins Bayview Medical Center, and who consent to undergo a urogynecologic surgical procedure, will be considered for inclusion in the study. Their histories will be reviewed by their attending surgeon and if they meet inclusion and exclusion criteria, they will be recruited for participation. The primary investigator and co-investigators (attending physician, fellows) will determine patient eligibility. Regarding privacy issues, the patients will be consented for both the procedure and for the study with careful attention made to emphasize patient confidentiality. When the patient presents for surgery, they will be randomized to receive either preoperative pyridium or intraoperative fluorescein or no dye. Given the color differences between the dyes, blinding will not occur. The process for recruitment will be consistent and any deviations from the protocol will be reported to the Johns Hopkins Internal Review Board.


Eligibility criteria: Inclusion Criteria:

• English speaking, female patients, ages 18 and older, undergoing urogynecologic surgery for pelvic organ prolapse or urinary incontinence with a planned concomitant cystoscopy at Johns Hopkins Bayview

Exclusion Criteria:

* Non-English speaking,
* Known allergic reactions or sensitivities to sodium fluorescein or phenazopyridine
* Known glucose-6-phosphate dehydrogenase or nicotinamide adenine dinucleotide- methemoglobin reductase deficiency
* Pregnant or breastfeeding
* Known renal disease or renal failure
* Undergoing concomitant non-urogynecologic procedures
* Dementia or cognitive impairment

Primary outcomes:
measure: Time required to complete cystoscopy
timeFrame: 30 min
measure: Time required to visualize ureteral jets
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: