louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03328559: Kinetics of Circulating Tumoral Cells in Bronchial Primitive Cancer
Official title: Kinetics of Circulating Tumoral Cells in Bronchial Primitive Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchial Cancer
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The pronostic value of Circulating Tumoral Cells(CTC) 's dosage by the method ISET® (tumoral cell isolation by size) in patients with bronchial cancer was previously demonstrated.

However, no kinetic study was ever realized to study the value of the CTC as predictive indicator of answer to the therapy. This project plans to study patients in an early stage and patients at advance stage locally moved forward or metastatic of the disease by evaluation of the presence and the number of CTC before every cure. This collaborative and original study should allow to refine the diagnoses of answer and to plan the possible relapses what would allow a premature institution of the treatment.


Eligibility criteria: Inclusion Criteria:

* patients with non-small cell lung cancer
* accepting participation

Exclusion Criteria:

* refusing participation

Primary outcomes:
measure: numeration of CTC (circulant tumoral cell)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Jean P Tredaniel, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02899559: Messages and Plans to Increase Gym Utilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Rutgers, The State University of New Jersey
First posted: 2016-09-14
Enrollment: 1000
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: This primary object of this study is to test to the hypothesis that the both the nudge and boost messages will increase short term gym utilization relative to the control condition but that only the boost message will increase long-term gym utilization.

Non-technical summary: College students will receive one of three messages about exercise. Their card swipe data as a measure of gym utilization will be tracked as an assessment of the effect of those messages.

Detailed description: Our study uses a survey methodology. Within the survey, participants are randomly assigned to experimental conditions. After completion of the survey, participants' real-world behavior is assessed via gym card swipe data.

Within the survey, an experimental quantitative three group design will be used to answer our research question. Thus, our independent variable has three levels: the control message, the nudge message, and the boost message. Our dependent variable will be collected gym card swipes over the semester.

The three experimental message conditions will be delivered within the questionnaire that participants complete. The control group will read only summary information about the David Pottruck Health and Fitness Center. Participants in the nudge condition will read a similar summary but will also be given a prompt to form an implementation intention. Those in the Boost condition will also have summary information about the Pottruck gym but will also be given information about why an implantation intention is an effective way to attain long term goals. They will also be given a prompt to form an implementation intention.

Eligibility criteria: Inclusion Criteria:

* Must be undergraduates at the University of Pennsylvania

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Gym Utilization Over the Course of a Semester
timeFrame: Up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katherine Milkman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01050959: Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study
Official title: Compassionate Use Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic, Medically Refractory Headache
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-01-18
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who were enrolled and implanted with the Bion® system during a prior feasibility clinical investigation of the device for occipital nerve stimulation (ONS) in the United States.

Brief summary: The purpose of this compassionate use study is to provide clinical and technical support of the Bion® microstimulator system to the subjects who have decided to keep the system for relief of headache symptoms that have not responded to medical treatment. These study subjects were enrolled and implanted with the Bion® system during a previous clinical investigation of the Bion® for occipital nerve stimulation (ONS) in the United States.


Eligibility criteria: Inclusion Criteria:

* Subject participated in a prior clinical feasibility study of the Bion for occipital nerve stimulation in the treatment of chronic headaches (IDE G030225) and remained implanted with the Bion system.
* Subject elects to enroll in this compassionate use study and provides written informed consent.
* Subject understands the type and duration of clinical, technical or product support provided in the study.
* Subject is willing to comply with protocol-required activities.

Exclusion Criteria:

* Subject is currently participating or intends to participate in another investigational drug or device clinical trial for chronic headaches during the study period.

Primary outcomes:
measure: Provision of one year of clinical and technical support
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute
state: Michigan
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Roshini Jain
role: STUDY_CHAIR
References:
Clinical trial NCT00701259: Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn
Official title: A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of Fourteen Day Treatment With Lansoprazole 15 mg or 30 mg Once a Day in Frequent Nighttime Heartburn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Frequent Heartburn
Keywords: Frequent heartburn, proton pump inhibitor, lansoprazole
Treatment of
over 14 days
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 852
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: Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic stomach contents move upward into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing frequent nighttime heartburn.


Eligibility criteria: Inclusion Criteria:

* Experiencing heartburn at least 2 days per week during the nighttime period over the past month.
* Having heartburn that responds to heartburn medication.
* Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.

Exclusion Criteria:

* Having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy).
* Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.

"Other protocol-defined inclusion/exclusion criteria may apply"

Primary outcomes:
measure: Percentage of nighttimes with no heartburn during 14 days of double-blind treatment in subjects with frequent heartburn.
timeFrame: 14 days
Secondary outcomes:
measure: Proportion of 24 hour days with no heartburn during 14 days of treatment. Proportion of subjects with no heartburn during day 1 (the 24 hours following the first dose. The evaluation of lansoprazole safety.
timeFrame: 14 days
Other outcomes:
Locations:
city: Parsippany
country: United States
facility: Not applicable - enrollment complete
state: New Jersey
Study officials:
References:
Clinical trial NCT03773159: Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
Official title: Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Von Willebrand Diseases
Major Constitutional Thrombopathy
Patient on Antiplatelet Drugs
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with von Willebrand disease or major constitutional thrombopathy or patient on antiplatelet drugs

Brief summary: Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand factor, without taking into account blood flow and other blood cells (red and white blood cells). Tests for whole blood and flow conditions exist, but there is currently no test that comes close to actual physiological conditions.

An exploration of whole blood haemostasis in a device that is similar to a blood vessel and at different flow conditions (venous and arterial) could help to better identify the risk of bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy).

The objective of the study is to evaluate the performance of this new hemostasis test in whole blood and under flow conditions.

Participation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for patients) or during blood donation (for controls).


Eligibility criteria: Inclusion Criteria:

* person who has given oral consent
* adult
* blood donor at EFS Bourgogne Franche-Comté
* or patient with von Willebrand disease or major constitutional thrombopathy followed by the Resource and Competence Centre (CRC) - Constitutional Hemorrhagic Diseases of Dijon or Besançon
* or patient on antiplatelet drugs consulting for thrombosis at the Dijon Bourgogne or Besançon Hospital

Exclusion Criteria:

* a person who is not affiliated to or not a beneficiary of national health insurance
* person subject to court-ordered protection (curatorship, guardianship)
* pregnant, parturient or breastfeeding woman
* a person who is unable to consent
* person on anti-inflammatory treatment and serotonin reuptake inhibitor antidepressants (platelet function disorders)

Primary outcomes:
measure: Repeatability and reproducibility of the result in controls
timeFrame: Baseline
measure: Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT03162159: Adult Height Prediction in Congenital Adrenal Hyperplasia
Official title: An Adult Height Prediction Model for Congenital Adrenal Hyperplasia From a National Cohort (OPALE Model Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Adrenal Hyperplasia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adullts with Congenital Adrenal Hyperplasia

Brief summary: Congenital Adrenal Hyperplasia (CAH) is a genetic rare disease, which alters the adrenal production of gluco and mineralo corticoïds. The treatment consists in supplementing children with hydrocortisone. Despite care for these children has improved substantially across decades, short adult height (AH) still remains an important consequence of the disease. About 20% of patients have an AH below 2 standard deviations compared to their expected AH.

In the OPALE-Model study, the investigators want to collect data from a cohort of 496 CAH French patients, born between 1970 and 1991 with a known genotype. Using their age, sex, growth, disease, bone maturation and pubertal data, the investigators will build a model which allows to predict their AH using data available at 8 years of age. The growth charts built from this cohort have shown that currently used formula to calculate the predicted AH (Bayley-Pineau's formula) is not applicable to children with CAH.

In this project, the investigators plan to compute an AH prediction model using data from children born between 1970 and 1993, and to validate the model using data from a different cohort (i.e. children born between 1994 and 1998). this choice was due to availability of data for computing the model first, and in a second stage, data from more recently born patients.


Eligibility criteria: Inclusion Criteria:

* children with CAH, genetically proven, classical form, virilizing form, with deficit of 21 hydroxylase, 11 beta hydroxylase, or 3 beta ol dehydrogenase, born between 1972-1993 (cohort 1) and 1994-1998 (cohort 2).
* medical charts should be available.

Exclusion Criteria:

* Patients with chronic growth altering disease, Turner syndrome, or other genetic anomaly
* Patients having received any treatment with Growth Hormone (GH)

Primary outcomes:
measure: Adult height (AH)
timeFrame: up to 18 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Catherine Cornu, MD
role: STUDY_CHAIR
References:
citation: Bretones P, Riche B, Pichot E, David M, Roy P, Tardy V, Kassai B, Gaillard S, Bernoux D, Morel Y, Chatelain P, Nicolino M, Cornu C; French Collaborative CAH Growth Study Group. Growth curves for congenital adrenal hyperplasia from a national retrospective cohort. J Pediatr Endocrinol Metab. 2016 Dec 1;29(12):1379-1388. doi: 10.1515/jpem-2016-0156.
Clinical trial NCT04531059: Rescue Therapy for Helicobacter Pylori Eradication Treatment
Official title: Rescue Therapy for Helicobacter Pylori Eradication: a Randomized Non-Inferiority Trial of Minocycline or Tetracycline in Bismuth Quadruple Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
rescue therapy
minocycline
tetracycline
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.


Eligibility criteria: Inclusion Criteria:

* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with previous treatment failure

Exclusion Criteria:

* subjects naive to H. pylori treatment,
* under 18 or over 80 years old
* history of gastrectomy
* pregnant or lactating women
* severe systemic diseases or malignancy
* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
* contraindications to the study drugs

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: Within 7 days after completion of therapy
measure: Compliance rate
timeFrame: Within 7 days after completion of therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital, Tongji University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University school of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT01034059: Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever
Official title: Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neutropenic Fever
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hematological malignancy developing neutropenic fever after chemotherapy

Brief summary: The soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) was an established biomarker useful for infection in non-neutropenic patients. In this study, we tested sTREM-1 in the patients with neutropenic fever. Pro-calcitonin (PCT) and C-reactive protein (CRP) were also measured. We planned to investigate and explore the role of sTREM-1 in early diagnosis of infection in patients with neutropenic fever.

Detailed description: Patients with hematological malignancies developed neutropenia after chemotherapy. We checked the serum level of sTREM-1 in patients with neutropenic fever. Those patients were classified to 2 groups: documented infection or low likelihood of infection. Their sTREM-1 level was measured and was compared with other biomarker such as CRP and procalcitonin. The value of sTREM-1 for diagnosis of infection in patients with neutropenic fever was thus evaluated.

Eligibility criteria: Inclusion Criteria:

* chemotherapy-related neutropenia (granulocytes \< 0.5 × 109/l or leukocytes \< 1 × 109/l) and fever (body temperature \> 38.0°C over a 6 hour observation period or body temperature ≥ 38.5°C once.

Exclusion Criteria:

* prolonged fever before presenting for admission,
* antibiotics therapy in the past 72 hours,
* more than two sites of infectious focus,
* concomitant solid organ malignancy and blast in hemogram.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Laboratory Medicine, National Taiwan University Hospital and College of Medicine, Taipei
name: Szu-Chun Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01862159: Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery
Official title: Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Keywords: bariatric surgery
postoperative complications
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Scandinavian Obesity Surgery Registry
First posted: 2013-05-24
Enrollment: 25038
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing bariatric surgery in Sweden

Brief summary: The rate of serious complications are relatively low in bariatric surgery today, but still 3-4 % will suffer from a serious complication. There are factors known before the surgery or during the operation that are likely to increase the risk for a serious complication. If the investigators are aware of these we can optimize the patients risk factors prior to the operation or at least increase the awareness of the increased risk in some patients given the presence of risk factors.

Detailed description: Data is collected prospectively to the Scandinavian Obesity Surgery Registry. Today all 44 clinics performing bariatric surgery in Sweden submits data on baseline characteristics, operational data and data from a 30 days, 1 year, 2 years and 5 years follow up for all patients. The database is compared annually to the Swedish civil registry to cover all mortality.

From the database we will identify patients who underwent a bariatric procedure between May 1st 2007 and September 30th 2012. Patients undergoing other bariatric procedures than laparoscopic gastric bypass or revisional surgery will be excluded.

The data will be analyzed with "Chi-2" test, logarithmic regression, linear regression or t-test when appropriate. Odds ratio will be calculated.

Eligibility criteria: Inclusion Criteria:

Undergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry

Exclusion Criteria:

Undergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded.

Lost to follow up.

Primary outcomes:
measure: Serious Complications
timeFrame: 30 days or the postoperative hospital stay if longer than 30 days
Secondary outcomes:
measure: Operating Time
timeFrame: operation
measure: Length of Stay
timeFrame: 30 days or the postoperative hospital stay if longer than 30 days
measure: Specific Postoperative Complications
timeFrame: 30 days or the postoperative hospital stay if longer than 30 days
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: University Hospital Örebro
Study officials:
affiliation: The Scandinavian Obesity Surgery Registry
name: Ingmar Näslund, MD, PhD
role: STUDY_CHAIR
affiliation: Region Örebro County
name: Erik Stenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: