louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03350685: Detection and Characteristic of Whipple Diseases in the Great Britany
Official title: Detection and Characteristic of Whipple Diseases in the Great Britany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Whipple Disease
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis whipple's disease

Brief summary: Whipple's disease is a chronic systemic infection caused by ubiquitous bacterium Tropheryma wipplei on a genetic predisposition which should be considered in patients with recurrent episodes of seronegative arthritis, erosive or not, or inflammatory low back pain, chronic diarrhea, persistent fever, unexplained neurological signs, uveitis, endocarditis, and epithelioid granuloma.

Laboratory tests may show malabsorption, erythrocyte sedimentation rate and C-reactive protein elevation, anemia, thrombocytosis, eosinophilia and lymphopenia.

None of theses findings is specific and most patients have arthritis or low back pain mimicking rheumatoid arthritis and spondyloarthritis.

As the disease is rare, chance for positive polymerase chain reaction testing for Tropheryma whipplei is low in this context.


Eligibility criteria: Inclusion Criteria:

* Adult
* patient with at least a screening test for Whipple'disease
* participation agreement,

Exclusion Criteria:

* No test for Whipple'disease

Primary outcomes:
measure: Number of patients diagnosed as whipple's disease
timeFrame: Day 0 ( Date of diagnostic)
Secondary outcomes:
measure: Number of test performed in each centre
timeFrame: Day 0 (Date of diagnostic)
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'ANGERS
city: Brest
country: France
facility: CHRU de Brest
city: Le Mans
country: France
facility: CH le MAns
city: Nantes
country: France
facility: CHU de Nantes
city: Orleans
country: France
facility: CH d'ORLEANS
city: Poitiers
country: France
facility: CHU de POITIERS
city: Rennes
country: France
facility: CHU de Rennes
city: Tours
country: France
facility: CHU de Tours
Study officials:
References:
Clinical trial NCT03920085: Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems
Official title: Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: LifeScan Scotland Ltd
Sponsor class: INDUSTRY
Collaborators: name: MAC Clinical Research
First posted: 2019-04-18
Enrollment: 123
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Study to determine the performance of the LifeScan BGMS when conducted at MAC clinical site.

Detailed description: This study will evaluate the performance of the MAC clinical site to evaluate accuracy performance of LifeScan blood glucose monitoring systems as it is conducted at other LifeScan UK affiliated clinic sites. Multiple LifeScan Blood Glucose Monitoring System (BGMS) will be tested with production lots which have passed release testing.

Eligibility criteria: Inclusion Criteria:

* Participants must be enrolled in LifeScan Patient Registry.
* Participants must have read the Information sheet and signed an informedconsent form \>prior to study participation.
* Participants must be 16 years or older.
* Participants must be diagnosed with Diabetes

Exclusion Criteria:

\> Participants not enrolled in the LifeScan Patient Registry

Primary outcomes:
measure: Clinical Evaluation of Blood Glucose result (mg/dl) from LifeScan Blood Glucose Monitoring Systems by comparison of a blood glucose result (mg/dl) obtained from a reference instrument (YSI2900) to demonstrate accuracy (%).
timeFrame: Less than 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
Study officials:
References:
Clinical trial NCT04573985: Impact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder
Official title: Impact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Caregiver of Patient With Alzheimer Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to assess the effectiveness of serious EUREKOI gambling on the anxiety of family caregivers of patients with newly diagnosed Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Men or women over 18 years old;
* Primary caregiver of a patient with a mild-stage major neurocognitive disorder newly diagnosed according to the DSM 5 criteria;
* Signature of informed consent.

Exclusion Criteria:

* Subject not speaking French, not reading French
* Subject with visual impairment
* Subject under tutorship or curatorship.

Primary outcomes:
measure: Efficacity of the serious game Eurekoi on anxiety of familial caregiver of patient with Alzheimer Disease
timeFrame: 3 months
Secondary outcomes:
measure: Change of knowledge of familial caregiver about cognitive troubles
timeFrame: 3 months
measure: Evaluate satisfaction of the familial caregivers about the session with the game EUREKOI
timeFrame: 3 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT02516085: Improved Muscle Function in Duchenne Muscular Dystrophy Through L-Arginine and Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Duchenne Muscular Dystrophy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2015-08-05
Enrollment: 5
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to show that the intake of L-arginine and metformin improves muscle function and delays disease progression in patients with Duchenne's muscular dystrophy.

Detailed description: This is an investigator-initiated, open-label, single-center, proof-of-concept-study. The study medication consists of L-arginine and metformin. The duration of the study is 16 weeks and comprehends one screening and four study visits.

Eligibility criteria: Inclusion Criteria:

* Molecular diagnosis of DMD
* Patients 7 - 10 years of age at time of screening
* Ambulant

Exclusion Criteria:

* Previous (3 months or less) or concomitant participation in another therapeutic trial
* Use of L-arginine, L-citrulline or metformin within the last 3 months
* Known individual hypersensitivity to L-citrulline or metformin
* Other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of the investigator

Primary outcomes:
measure: Mean change of muscle metabolism
timeFrame: baseline to week 16
Secondary outcomes:
measure: In vivo change of muscle metabolism
timeFrame: baseline to week 16
Other outcomes:
Locations:
Study officials:
affiliation: University of Basel, Children's Hospital
name: Dirk Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hafner P, Bonati U, Erne B, Schmid M, Rubino D, Pohlman U, Peters T, Rutz E, Frank S, Neuhaus C, Deuster S, Gloor M, Bieri O, Fischmann A, Sinnreich M, Gueven N, Fischer D. Improved Muscle Function in Duchenne Muscular Dystrophy through L-Arginine and Metformin: An Investigator-Initiated, Open-Label, Single-Center, Proof-Of-Concept-Study. PLoS One. 2016 Jan 22;11(1):e0147634. doi: 10.1371/journal.pone.0147634. eCollection 2016.
Clinical trial NCT00215085: Cardiac Tumors in Children
Official title: Cardiac Tumors in Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Heart Disease
Keywords: pediatric health
cardiac
cardiac tumor
children
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the congenital surgery database

* Children who have been treated for a primary cardiac tumor

Brief summary: The purpose of this study is to define the natural history of untreated cardiac tumors, study the pathology of primary cardiac tumors, review the surgical treatment and results of primary cardiac tumors and to determine the prognosis for these tumors.

Detailed description: Primary cardiac tumors in children are extremely rare. Benign tumors are typically myxomas, lipomas, and rhabdomyomas, while malignant tumors are typically angiosarcomas and rhabdomyosarcomas. Due to the rarity of these tumors, it is difficult to gather meaningful information regarding their natural history, pathology and treatment.

The primary aims are to define the natural history of untreated cardiac tumors, study the pathology of primary cardiac tumors, review the surgical treatment and results of primary cardiac tumors and to determine the prognosis for these tumors. The secondary aims are to discover patterns and consistencies among primary cardiac tumors and to define the best treatment options for these patients. The study will be conducted through a retrospective chart review of about 70 patients.

Eligibility criteria: Inclusion Criteria:

* Patients in the congenital surgery database
* Children who have been treated for a primary cardiac tumor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Brian Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01504685: Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass
Official title: Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Morbid obesity
Obesity surgery
Gastric bypass
Banded gastric bypass
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is comparatively analyze the advantages and disadvantages of banded versus unbanded laparoscopic Roux-en-Y gastric bypass (RYGB).

The outcome variables of the general study included morbidity, maximal weight loss, and late weight regain.

Detailed description: Obesity is a public health problem that has grown exponentially worldwide. Bariatric surgery has been recognized as the most effective treatment for morbid obesity. However, the debate about the best surgical procedure is still considerable.

Among a wide range of operations that have been used for morbid obesity, Roux-en-Y gastric bypass (RYGB) has shown an appropriate risk/benefit balance and has achieved a high degree of acceptance in America.

The weight loss pattern in RYGB is characteristic and includes significant eight loss during the first 2 years after surgery, followed by some weight regain after the second or third postoperative year. To prevent this some authors suggest the placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy. This procedure has been called banded RYGB.

Eligibility criteria: Inclusion Criteria:

* body mass index of 40-55 kg/m2
* agreed to participate in this study with informed consent signed

Primary outcomes:
measure: Number of participants with postoperative morbidity
timeFrame: up to 5 years
measure: Change from Baseline weight assessed at different time points to determine maximal weight loss,
timeFrame: 3,6,9 months and 1,2,5 years
measure: Changes in weight assessed at different time points to determine weight regain
timeFrame: 3,6,9 months and 1,2,5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutrición "Salavador Zubirán"
name: Miguel F Herrera, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01307085: Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection
Official title: Effect of Remote Ischemic Preconditioning on Lung Injury in Patients Undergoing Pulmonary Resection:a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Keywords: remote ischemic preconditioning
lung injury
pulmonary resection
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether ischemic preconditioning reduces lung injury in patients undergoing pulmonary resection.

Detailed description: Remote ischemic preconditioning is an intervention in which brief ischemia of one tissue or organ protects remote organs from a sustained episode of ischemia. It is known that one-lung ventilation in patients undergoing pulmonary resection, which may cause acute lung injury. The investigators did a single-blinded randomised controlled study to establish whether remote ischemic preconditioning reduces lung injury in these patients.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of pulmonary carcinoma
* Must be received pulmonary lobectomy

Exclusion Criteria:

* Cardiac disease categorized as NYHA classes II-IV
* Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) \<60 mmHg or FEV1\<50% predicted),
* Pre-existing coagulopathy or thrombocytopenia
* Prior receipt of chemotherapy or radiation therapy or immunotherapy
* Systemic or local active infections (either clinically defined or suggested by evidence such as elevated C-reactive protein levels, leukocytosis, or a body temperature\>38℃)
* Peripheral vascular disease affecting the upper limbs
* Administration of vitamins, nonsteroidal anti-inflammatory agent or corticosteroid within 3 months.

Primary outcomes:
measure: Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing pulmonary lobectomy
timeFrame: June,2013
Secondary outcomes:
measure: Cs and Cd
timeFrame: June,2013
measure: IL-6 and TNF-α
timeFrame: June,2013
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
name: Xuan Ke Liu, Ph.d
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05493085: Quadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients for Upper Abdominal Surgeries
Official title: Quadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients Undergoing Upper Abdominal Surgeries.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain, Acute
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 52
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare between the analgesic effect of the Ultrasound-guided quadratus lumborum block and single Caudal epidural injection in pediatric patients undergoing surgeries with supraumbilical incisions.


Eligibility criteria: Inclusion Criteria:

* Any pediatric patient aged from 2 to 8 years undergoing abdominal Surgery with Supraumbilical umbilical incision

Exclusion Criteria:

* parents refusal to participate in the study,
* previous history of allergy to local anesthetics
* hemodynamic instability
* Coagulopathy,

Primary outcomes:
measure: Pain score
timeFrame: 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university hospital
state: Abbasia
Study officials:
affiliation: AinShams University, Anesthesia department
name: Sherif Wadei, MD
role: STUDY_CHAIR
References:
Clinical trial NCT07012785: Efficacy Analysis of Saccharomyces Boulardii Combined With Minocycline in Treatment-naïve Patients With Helicobacter Pylori Infection
Official title: Efficacy Analysis of Saccharomyces Boulardii Combined With Minocycline in Treatment-naïve Patients With Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: H. Pylori Infection
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the efficacy and safety of Saccharomyces boulardii combined with triple therapy containing minocycline in the initial eradication of Helicobacter pylori (H. pylori) infection


Eligibility criteria: Inclusion Criteria:

1. Aged 18-70 years, regardless of gender;
2. Positive 13C/14C urea breath test result;
3. No previous history of H. pylori eradication treatment;
4. Agreement to participate in this study and signing of the informed consent form.

Exclusion Criteria:

1. History of ≥ 1 instance of failed H. pylori eradication;
2. Use of antibiotics (including antibacterial traditional Chinese medicines), nonsteroidal anti-inflammatory drugs (NSAIDS), bismuth agents, H2 receptor antagonists (H2RAs), proton-pump inhibitors (PPIs), and potassium-competitive acid blockers (P-CAB) within 4 weeks before treatment;
3. Plans to conceive, pregnancy, or breastfeeding;
4. Severe liver, kidney, or cardiovascular diseases; malignancies; and alcoholism;
5. Allergies to the drugs used in this study or a history of penicillin allergy;
6. The inability to correctly express one's symptoms and wishes, such as inability due to mental illness or severe neurosis.

Primary outcomes:
measure: H. Pylori eradication rate
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00425685: Use of ECMO in Acute MI
Official title: Use of Extracorporeal Membrane Oxygenation in Treatment of Acute Myocardial Infarction Following Cardiac Surgery Procedures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ECMO and Acute MI
Keywords: cardiopulmonary resuscitation, ECMO, shock, survival, heart failure, transplantation, heart assist device.
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2007-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: ECMO offers an acceptable cardiopulmonary support in adults with similar hospital survival rates as other mechanical support. It is versatile and salvages some patients, who may otherwise die. Improvement in intermediate term outcome will require multidisciplinary approach to protect organ function and limit organ injury during this support.

Detailed description: Extracorporeal membrane oxygenation (ECMO) is an established treatment option in patients with Cardiogenic Schock. We retrospectively reviewed early and mid-term outcome as well as predictors of survival during using ECMO. This report reviews our experience with this support system in last 3 years.

Eligibility criteria: Inclusion Criteria:

* Acute MI

Exclusion Criteria:

* Contraindication against ECMO

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: JW Goethe University
name: Farhad Bakhtiary, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01193985: Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair
Official title: Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Novus Scientific
Sponsor class: INDUSTRY
First posted: 2010-09-02
Enrollment: 40
Sex: MALE
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 an open, uncontrolled multicenter clinical study to assess the safety and performance of the WK-6 surgical mesh in adult patients with unilateral inguinal hernia.

The primary objective is to determine the safety of the WK-6 surgical mesh. Data will be compared retrospectively with published studies on inguinal hernia mesh.

The secondary objectives are to explore the performance of the surgical mesh by measuring the pain pre and post surgery as well as a number of relevant variables for establishing the performance of the mesh. Data will be compared retrospectively with previous studies on inguinal hernia mesh with a follow-up of at least one year.


Eligibility criteria: Inclusion Criteria:

* Patients who have given informed consent
* Male, 18 years and older.
* Patients with primary unilateral inguinal hernia
* Planned surgery procedure according to Lichtenstein technique

Exclusion Criteria:

* Patients who are unwilling and/or unable to give informed consent
* Hernia strangulated or irreducible
* Recurrent Hernia
* Previous mesh surgery on the same side
* Class \>IIa patients
* Unable to walk 500 meters
* BMI \>30 kg/m2
* Warfarin treatment, ongoing or within two weeks of surgery.
* Peripheral artery disease
* Chronic back pain, as judged by the investigator.
* Hip joint arthrosis
* Hypermobility syndrome, as judged by the investigator.
* Constipation
* Drug or alcohol abuse
* COPD (chronic obstructive pulmonary disease)
* Patients at increased risk of death from a pre-existing concurrent illness
* Patients participating in another clinical study
* Patients who have used any other investigational drug or device within 1 month
* Patients who cannot communicate reliably with the investigator
* Patients who are unlikely to cooperate with the requirements of the study
* Patients who are employees at the investigational site; relatives or spouse of the PI.
* Patients not suitable based upon investigator decision

Primary outcomes:
measure: Frequency of Adverse Events or Serious Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Pain
timeFrame: 12 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Kungsbacka
country: Sweden
facility: Kungsbacka Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Stellan Björck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: