louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02732249: Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment
Official title: A Randomized Clinical Trial of Clarithromycin/Bismuth Containing Quadruple Therapy for Helicobacter Pylori First-line Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Clarithromycin
Amoxicillin
Metronidazole
Eradication
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 66
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: Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical ﬁrst-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.


Eligibility criteria: Inclusion Criteria:

* Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* confirmed H. pylori infection

Exclusion Criteria:

* Previous H. pylori eradication therapy
* Less than 18 years old
* With history of H. pylori infection treatment
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

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: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Hong lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03731949: Placental Volume Analysis During Pregnanay
Official title: Placental Volume Analysis and Monitoring and Vascularity Assessment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Diseases
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
name: National Research Centre, Egypt
First posted: 2018-11-06
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * pregnant ladies between 20 - 40 years old
* ladies pregnant from 14 weeks till term

Brief summary: Placenta grows with advancing gestational age amonitoring of placental growth is important in pregnancy evaluation

Detailed description: assessment of placental size is very important in evaluating the pregnancy Placenta is one of the most important organs that control pregnancy outcome

Eligibility criteria: Inclusion Criteria:

* pregnant ladies between 20 - 40 years old
* ladies pregnant from 14 weeks till term

Exclusion Criteria:

* pregnant ladies in first trimester

Primary outcomes:
measure: the volume of every placenta at the given time of scan
timeFrame: within 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01324349: Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery
Official title: A Prospective, Multi-Center, Randomized, Single-Blind Study to Compare the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Disease
Keywords: Hepatic
Topical Hemostat
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery. The performance of the Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic techniques.


Eligibility criteria: Major Inclusion Criteria:

* Scheduled for non-emergent, hepatic surgery
* Presence of an appropriate target bleeding site (TBS) as defined by the protocol

Major Exclusion Criteria:

* Subject will be undergoing a laparoscopic hepatic procedure where the Hemostatic Patch will be delivered and applied through a trocar
* In subjects with documented history of cirrhosis, subject has uncorrected platelet count \<60,000 per mm³ as determined by laboratory tests performed immediately prior to surgery
* Subject has severe coagulopathy defined as INR \> 2.0
* Subject has Total Bilirubin \>2.5mg/dL
* Subject has an active local infection at the Target Bleeding Site
* Study procedure involves a liver transplant recipient

Primary outcomes:
measure: Median Time to Achieve Hemostasis Following Application of Study Treatment.
timeFrame: Intra-operative (day 1)
Secondary outcomes:
measure: Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application
timeFrame: Intra-operative (day 1)
measure: Number of Subjects With Treatment-emergent Adverse Events
timeFrame: Up to 30 days post surgery.
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: München
country: Germany
Study officials:
affiliation: Medtronic - MITG
name: Amy Pollack, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06143449: Taiwan Diabetes Registry
Official title: Taiwan Diabetes Registry (TDR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Lead sponsor: The Diabetes Association of the Republic of China (Taiwan)
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 24000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes mellitus

Brief summary: To Investigate the Risk Factors, Life Style and Treatments of the Microvascular Disease，Macrovascular Disease and Neuropathy in Patients With Diabetes.

Detailed description: At the first year (2015), the patients ever enrolled into the quality control study by Taiwan Association of Diabetes Educators in 2006 and 2011 will be recruited, and their relevant clinical data will be regularly registered yearly until 2030. In addition, it is planned that type 1 diabetic patients will be enrolled, and their clinical data will be regularly recorded yearly until 2030. Also, newly diagnosed type 2 diabetic patients will be recruited, and their clinical data will be regularly entered to the diabetes web-based system yearly until 2030. We will also include pregnant patients with diabetes since 2023, and their data will be monitored and followed until 2030. Finally, we will also include pregnant patients with diabetes since 2023, and their data will be monitored and followed until 2030.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes mellitus

Exclusion Criteria:

* Patients who do not have diabetes mellitus
* Participating in an interventional trial requiring informed consent

Primary outcomes:
measure: Provide data on patient characteristics
timeFrame: Ten years
measure: Provide data on disease management.
timeFrame: Ten years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: The Diabetes Association of the Republic of China (Taiwan)
Study officials:
name: The Diabetes Association of the Republic of China (Taiwan)
References:
Clinical trial NCT05128149: Metabolic Control and Patient Well-being in Phenylketonuria: do Guidelines Make a Difference?
Official title: Metabolic Control and Patient Well-being in Phenylketonuria: do Guidelines Make a Difference?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Phenylketonurias
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: UChildrenVienna
name: University Children's Hospital Basel
name: Insel Gruppe AG, University Hospital Bern
First posted: 2021-11-19
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PKU patients \> 10 years and their parents

Brief summary: Treatment of PKU implies for most patients that with strict adherence to dietary treatment they can achieve excellent neurocognitive outcome. Dietary treatment, though, is hard to comply to every day and with every single meal. Unsurprisingly, health-related quality of life (HrQol) is negatively affected if patients have to follow a dietary regime of this kind. Adherence to treatment in PKU is very variable. Factors of significant impact on adherence to treatment and well-being in chronic disease such as self-efficacy or parenting stress have not yet been widely investigated in PKU patients.

The ideal treatment prescription (and guideline) recommends as much as necessary and as little as possible, based on the best evidence available. Patients should neither be deprived of treatment options nor be exposed to overtreatment.

This study investigates adherence, metabolic control, HrQol in PKU patients treated by centres which follow different guidelines


Eligibility criteria: Inclusion Criteria:- Patients with PKU from age 10 years requiring dietary and / or pharmacological treatment according to locally applied guidelines

* Parents of patients with PKU aged 10 to 18 years requiring dietary and / or pharmacological treatment according to locally applied guidelines
* Ability and willingness to answer the questionnaires and follow the study procedures
* Informed consent as documented by signature

Exclusion criteria for patients and parents :

* Inability to follow the procedures of the study, e.g. due to language problems or severely reduced health status
* Pregnant patients or patients who have disclosed to their physician that they are planning a pregnancy in the near future
* Hyperphenylalaninaemia or mild forms of PKU or other inborn errors associated with elevated Phe but not requiring dietary and / or pharmacological treatment according to locally applied guidelines
* No inform

Primary outcomes:
measure: Phe values
timeFrame: report on measurements from past 24 months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: one hour
measure: Self-efficacy
timeFrame: one hour
measure: Burden on family (patients from 10-18 years)
timeFrame: one hour
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Childrens Hospital Zürich
Study officials:
References:
Clinical trial NCT02639949: Measuring and Improving Medication Adherence in Kidney Transplant Patients
Official title: The Use of Random Telephone Calls to Measure Immunosuppressive Therapy Adherence in Patients With Renal Transplants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant Recipients
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2015-12-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nonadherence to medication is a major obstacle to successful treatment of renal transplant patients. This study has two primary aims. The first is to test whether a culturally sensitive cognitive-behavioral adherence promotion program could significantly improve medication adherence to tacrolimus prescription. Participants will be randomly assigned to either group CBT or to standard care. The second aim is to pilot a novel strategy of adherence measurement - unannounced telephone pill counts, which has been shown to be a valid and reliable means to measure medication adherence in other patient populations. Participants will be recruited from waiting area of the kidney transplant clinic at SUNY Downstate Medical Center in Brooklyn, NY. Three unannounced telephone pill counts will be conducted prior to start of the intervention in order to establish baseline adherence and three pill counts will be conducted post-intervention. Tacrolimus trough concentration levels will also be collected as an additional biological measure of adherence.


Eligibility criteria: Inclusion Criteria:

- current prescription of tacrolimus less than 98% adherence to medication prescription as determined by three baseline pill counts

Exclusion Criteria:

- lack of telephone to complete pill counts lack of English proficiency to participate in adherence promotion sessions

Primary outcomes:
measure: Adherence as measured by unannounced telephone pill count
timeFrame: 3 months
Secondary outcomes:
measure: degree of agreement between pill count data and laboratory tacrolimus levels
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
Clinical trial NCT06556849: Effectiveness of DIMS Spectacle as a Function of the Age
Official title: Effectiveness of Defocus Incorporated Multiple Segments in Slowing Myopia Progression as a Function of the Age in Pediatric Patients. Three Years Follow up.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients with documented progressive myopiua

Brief summary: Purpose: To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients.

Methods: This was a non-randomized experimenter-masked retrospective controlled observational study of European individuals aged 6 -16 years with progressive myopia but no ocular pathology. The charts of the participants allocated to receive DIMS spectacles (Hoya® MiyoSmart®) or single vision spectacle lenses (control group) were retrospectively reviewed. The key outcome variables, cycloplegic spherical equivalent (SE) and axial length (AL), were measured at baseline and at 36 month follow up. The results were stratified by age into four groups: patients that wore DIMS spectacles oldest or youngest than 10 years (respectively, group A, 20 patients mean age 13.6±2.2 and group C, 20 patients mean age 9.0±1.2) and age matched control groups (group B, 18 patients mean age 13.2±2.5 and group D, mean age 8.5±0.9).

Detailed description: Participants were allocated to the study groups, receiving DIMS spectacles, or to the control groups, wearing single vision spectacle lenses.

Eligibility criteria: Inclusion Criteria:

* patient age between 6-16 years
* progressive myopia with cycloplegic spherical equivalent (SE) from -0.50 to -4.00 diopters (D)
* astigmatism less than 2.50D, anisometropia under 1.25D

Exclusion Criteria:

* genetic syndromes suspected (e.g., Stickler, Marfan, etc.)
* systemic diseases
* eye diseases (such as glaucoma, juvenile cataracts, retinal abnormalities, any form of strabismus)

Primary outcomes:
measure: SE
timeFrame: 36 months
Secondary outcomes:
measure: AL
timeFrame: 36 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Luca Buzzonetti
Study officials:
affiliation: Bambino Gesù IRCCS Children's Hospital
name: Luca Buzzonetti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00805649: Combined Therapy in Age-Related Macular Degeneration (ARMD)
Official title: Combined Therapy in ARMD - Retrospective Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age-Related Macular Degeneration
Keywords: ARMD
combined therapy
efficacy
safety
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of combined intravitreal therapy with or without prior photodynamic therapy in patients with wet age-related macular degeneration (AMD).

In patients with wet AMD, a significant improvement in vision was observed after combined intravitreal therapy with or without prior photodynamic therapy. Both the pharmacological effects of the drugs and the physiological effects of the pars plana vitrectomy (posterior vitreous detachment, liquefaction, and oxygen redistribution) may have contributed to the long-term sustainability of the therapeutic benefits.

Detailed description: This prospective study of a case series included eyes with predominantly classic lesions (Group 1; n = 52) and eyes with occult lesions (Group 2; n = 106). Patients with predominantly classic lesions received low fluorescence photodynamic therapy (42 J/cm2 for 72 sec), followed by, 24 hours later, a 1.5 mL core pars plana vitrectomy with intravitreal injection of dexamethasone (0.8 mg) and bevacizumab (1.25 mg). Patients with occult lesions received a 0.4 mL core pars plana vitrectomy with intravitreal injection of triamcinolone (8 mg) and bevacizumab (1.25 mg). At baseline and follow-up examinations, the best-corrected visual acuity (BCVA; logMar), central macular thickness (optical coherence tomography), intraocular pressure (IOP; Goldmann tonometry) were determined. In addition, the need for retreatment was assessed, and adverse events were monitored.

Eligibility criteria: Inclusion Criteria:

* Wet age related macular degeneration

Exclusion Criteria:

* Opacities in lens or cornea
* Ongoing intraocular inflammation
* Trauma

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: at the day of exam
measure: Central macular thickness
timeFrame: at the day of exam
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Abteilung für Netzhaut und Glaskörperchirurgie
state: Hessen
Study officials:
References:
Clinical trial NCT00773149: Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia
Official title: Phase I/II Study of Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia (ALL) or ALL in Relapse.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Lymphocytic Leukemia
Keywords: Adult Acute Lymphocytic Leukemia
Alemtuzumab
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-10-16
Enrollment: 12
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells. Adult patients with ALL in relapse have less than 10% probability of long term survival. The present study will test the response rate (partial and complete remission) of refractory ALL or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be given for a hematopoietic stem cell transplant.

The use of G-CSF is justified by a possible increase in ADCC.

Detailed description: All patients receive Alemtuzumab in 3 successive phases:

Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance.

Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented.

Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months.

Eligibility criteria: Inclusion Criteria:

* Patients older than 15 years
* Refractory ALL
* ALL in relapse post chemotherapy or post transplant
* ALL blast cells expressing CD 52 antigen at any time during the evolution of the disease.
* Signed informed consent
* Patients under social security coverage
* Anti conceptional tablets in pre menopausal women.

Exclusion Criteria:

* Children below 15 years of age or aged 15
* Blast cells not expressing CD52 antigen (at all evaluations)
* HIV positivity
* ECOG Score 3 and 4
* Hypersensitivity to Alemtuzumab.
* Pregnancy or breast feeding.
* Other malignant disease in addition to ALL.

Primary outcomes:
measure: Partial and complete remission, overall response rates
timeFrame: At 2 years
Secondary outcomes:
measure: Valuation of tolerance, more particularly targeted at the immunodeficiency shortage, contagious complications and neurotoxicity assessed according to the NCI (National Cancer Institute) classification.
timeFrame: At 2 years
measure: Valuation of the response waiting time, from the first day of the induction treatment to the REEVOLUTING.
timeFrame: at 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint Antoine Hospital, Hematology Unit
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Norbert Claude GORIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: