louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01510860: Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
Official title: Double-blind, Double-dummy, Randomised, Crossover, Multicentre Phase IV Clinical Study Comparing the Effect of Ursofalk 500 mg Tablets od Versus Ursofalk 250 mg Capsules od on Liver Enzymes in the Treatment of Primary Biliary Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Biliary Cirrhosis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 65
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 purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).


Eligibility criteria: Inclusion Criteria:

* Negative pregnancy
* Signed informed consent
* Histologically proven non-cirrhotic liver disease

Exclusion Criteria:

* histologically proven cirrhosis
* PBC stage II+IV
* Positive HIV serology

Primary outcomes:
measure: Change of liver enzymes between baseline and the end of the treatment-period with Ursofalk 250 mg capsules and the end of treatment-period with Ursofalk 500 mg tablets.
timeFrame: Between baseline and week 24
Secondary outcomes:
measure: Quality of Life
timeFrame: Between baseline and week 24
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum Grosshadern
Study officials:
affiliation: Klinikum Grosshadern Munich
name: Christian Rust, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hopf C, Grieshaber R, Hartmann H, Hinrichsen H, Eisold M, Cordes HJ, Greinwald R, Rust C. Therapeutic Equivalence of Ursodeoxycholic Acid Tablets and Ursodeoxycholic Acid Capsules for the Treatment of Primary Biliary Cirrhosis. Clin Pharmacol Drug Dev. 2013 Jul;2(3):231-6. doi: 10.1002/cpdd.24. Epub 2013 Apr 15. No abstract available.
Clinical trial NCT02656160: Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults
Official title: The Effect of Dalfampridine (4-aminopyridine) on Genioglossus Muscle Activity During Wakefulness and Sleep in Healthy Control Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this protocol the investigators will test the effect of dalfampridine (a potassium channel blocker) on genioglossus muscle activity (EMG GG) during wakefulness and sleep in healthy control subjects.

Detailed description: Two overnight sleep studies, a placebo night and a drug night, will be performed approximately one week apart in random order. The placebo or drug will be administered 3 hours before lights out. At least 10 minutes of quiet wakefulness will be recorded to quantify the subject's awake EMG GG activity before the administration of placebo/dalfampridine.

EMG GG activity will be measured again 10 mins before lights off and during stable NREM and REM sleep (free of arousals and other artifacts).

During the second part of the night, the subjects will be connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which can provide a wide range of pressures between 20 and -20 cmH2O in order to modify upper airway pressure and measure change in EMG GG as a function of epiglottic pressure (muscle responsiveness).

Eligibility criteria: Inclusion Criteria:

* Healthy control subjects

Exclusion Criteria:

* Cardiovascular disease other than well controlled hypertension
* History of seizures

Primary outcomes:
measure: Genioglossus Activity During Sleep Expressed as %Wakefulness Value (Before Drug/Placebo Administration).
timeFrame: 1 night
Secondary outcomes:
measure: Change in EMG GG for cmH2O Change in Epiglottic Pressure. (GG%Max/cmH2O)
timeFrame: 1 night
Other outcomes:
Locations:
city: Boston
country: United States
facility: Sleep Disorders Research Program Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
citation: Taranto-Montemurro L, Sands SA, Azarbarzin A, Marques M, de Melo CM, Edwards BA, Eckert DJ, Messineo L, White DP, Wellman A. Effect of 4-Aminopyridine on Genioglossus Muscle Activity during Sleep in Healthy Adults. Ann Am Thorac Soc. 2017 Jul;14(7):1177-1183. doi: 10.1513/AnnalsATS.201701-006OC.
Clinical trial NCT02831660: CU Programme of Idarucizumab for Japanese Patients
Official title: A Compassionate Use Program of Idarucizumab for Reversal of the Anticoagulant Effects of Dabigatran in Japanese Patients Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemorrhage
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-07-13
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required.


Eligibility criteria: Inclusion criteria:

* Currently taking dabigatran etexilate.
* Age \>= 20 years at entry.
* Written Informed consent
* Group A:

  -- Uncontrolled or life-threatening judged by the physician to require a reversal agent.
* Group B:

  * A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.

Exclusion criteria:

* Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
* Group A:

  * Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care.
  * Patients with no clinical signs of bleeding.
* Group B:

  * surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.

Primary outcomes:
measure: Percentage of Subjects With Drug-related Adverse Events
timeFrame: from first drug administration until 5 days after last drug administration, up to 6 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka, Kasuga
country: Japan
facility: Fukuoka Tokushukai Medical Center
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT06255860: COVID-19 and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk / World Health Organization (WHO)
Official title: SARS-COV-2 (virus Responsible of COVID-19) Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV-2 Infection
MIS-C
Lead sponsor: Association Clinique Thérapeutique Infantile du val de Marne
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 204
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with SARS-CoV-2 and children with MIS-C between the 01 sep 2021 and 30 apr 2022 period

Brief summary: This study is a multicenter, international, non interventional, retrospective study about SARS-CoV-2 and Multisystem Inflammatory Syndrome (MIS-C) reinfection risk in children.

Detailed description: This study is based to data collection of cases (patients with MIS-C) compare to controls (patients with SARS-CoV-2 infection) occurring between 01 sep 2021 and 30 apr 2022. For this study cases and controls group will be matched for analyses.

The main of this study is to evaluate the difference of risk of occurrence of MIS-C between a first SARS-CoV-2 infection and a reinfection with SARS-CoV-2.

Eligibility criteria: Inclusion Criteria:

group 1: cases

* Patients with MIS-C (following SARS CoV-2 infection)
* Hospitalised between the 01 sep 2021 and 30 apr 2022
* Under 18 years of age
* Not vaccinated for SARS-CoV-2

group 2: controls

* Patients not hospitalised, treated by outpatient care
* With documented SARS-CoV-2 infection between the 01 sep 2021 and 30 apr 2022
* Matched with a case on age (+/- 6 months), gender and country
* Not vaccinated for SARS-CoV-2

Exclusion Criteria:

- Refusal to participate by patient relative or legal representative

Primary outcomes:
measure: proportion of MIS-C cases occurred after first SARS-CoV-2 infection
timeFrame: 8 months
measure: proportion of MIS-C cases occurred after SARS-CoV-2 reinfection
timeFrame: 8 months
measure: Proportion of SARS-CoV-2 reinfection after first SARS-CoV-2 infection
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Créteil
country: France
facility: ACTIV
Study officials:
affiliation: Association Clinique Thérapeutique Infantile du val de Marne
name: Corinne Levy, Physician
role: STUDY_DIRECTOR
affiliation: Hôpital Robert Debré AP-HP, Paris 19
name: Naim Ouldali, Physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04456660: Comprehensive Assessment of Risks for Miscarriage.
Official title: Markers of Ultrasound, Immunologic & Serum Factors in the Comprehensive Analysis of Risks for Early Pregnancy Loss.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spontaneous Abortion
Lead sponsor: Orthogyn Medical Center, Bulgaria
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women between 18 and 50 years of age.

Brief summary: This study aims to determine the role of serum biomarkers and placental bloodflow in the comprehensive evaluation of the risk for spontaneous abortion

Detailed description: To study the added value (if any) of combining serum markers, immunologic factors, and ultrasound parameters in comprehensively evaluating the risk for spontaneous abortion.

Eligibility criteria: Inclusion Criteria:

* visualized fetal structures in utero \& heart pulsations until 8th week of gestation
* normal THS/T4 levels
* no uterine malformations
* BMI \< 27
* signed informed consent

Exclusion Criteria:

* fetal structures in utero \& heart pulsations not visualized until the 8th week of gestation
* elevated THS/T4 levels
* uterine malformations
* BMI \> 27

Primary outcomes:
measure: Occurence of a spontaneous abortion
timeFrame: Up to 24 weeks of gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Orthogyn Medical and Dental Center
Study officials:
affiliation: Orthogyn Medical Center
name: Petar N Ignatov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05817760: Z-plasty and Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web
Official title: Evaluation of Z-plasty Versus Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web in Pediatric Age Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urologic Diseases
Keywords: Penoscrotal web
Z-scrotoplasty
Heineke-Mikulicz
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2023-04-18
Enrollment: 40
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the surgical outcome of Z-scrotoplasty versus Heineke-Mikulicz scrotoplasty in the management of congenital penoscrotal web in pediatric age group.

The main question\[s\] it aims to answer are:

• Question 1: Is there a difference in the surgical outcome between using Z-scrotoplasty and Heinke Miculickz scrotoplasty in the management of congenital penoscrotal web?\] Participants will be divided into two groups; Group A treated by Z-scrotoplasty and Group B treated by Heineke Miculickz scrotoplasty.

Detailed description: Background: The penoscrotal web may be congenital or acquired after excessive removal of ventral skin during circumcision. There are several previously described surgical techniques for the treatment of congenital webbed penis without a clear comparison between their outcomes. Purpose: the objective of our study was to compare the surgical results of Z-scrotoplasty and Heineke-Mikulicz scrotoplasty in the treatment of congenital webbed penis. Patients \& Methods: Our prospective study included 40 uncircumcised patients presented with a webbed penis. They were divided into group A which was treated by Z-scrotoplasty and group B which was treated by Heineke-Mikulicz scrotoplasty.

Eligibility criteria: Inclusion Criteria:

* Patients with congenital penoscrotal web in the pediatric age group

Exclusion Criteria:

* Patients with any penile anomalies

Primary outcomes:
measure: Number of patients who developed post-operative penile edema, hematoma, adequate skin coverage and wound contracture with recurrent webbing will be assessed
timeFrame: One post-operative year
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Pediatric Surgery department
name: Ahmed Elrouby, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02608060: A Study to Assess the Hematopoyetic Response of Anemic Patients With Hematologic Malignancies Treated With Erythropoietin B
Official title: Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels of Patients With Anemia Related to Non- Hodgkin Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma, Treated With Erythropoietin B (Recormon) Using Pre-filled Syringe With 30000 IU, as Well as to Quantify the Risk Factors of Anemia and Its Impact on Quality of Life Related to Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine the efficacy, safety and effect on hemoglobin levels, of once weekly subcutaneous injections of epoetin beta (30,000 IU) in anemic participants with non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma. The anticipated study duration is 4 months, and the target sample size is 30 individuals.


Eligibility criteria: Inclusion Criteria:

* Adult participants with a diagnosis of non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma
* Anemia at Screening Visit

Exclusion Criteria:

* Transfusion of red blood cells within 2 months of study drug
* Treatment-resistant hypertension
* Acute or chronic bleeding (requiring therapy) within 3 months of study drug

Primary outcomes:
measure: Hemoglobin levels at 16 weeks
timeFrame: 16 Weeks
Secondary outcomes:
measure: Serum Iron, Ferritin and Transferrin Levels
timeFrame: 16 Weeks
measure: Time to Global Response
timeFrame: Up to 4 months
measure: Percentage of Participants with a Positive Response
timeFrame: Weeks 4 and 8
measure: Quality of Life in Relation to Grade of Anemia
timeFrame: Up to 4 months
measure: Quality of Life According to the Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument
timeFrame: Up to 4 months
measure: Tolerability - Incidence of Adverse Events
timeFrame: Up to 16 Weeks of treatment period
Other outcomes:
Locations:
city: Caracas
country: Venezuela
city: Caracas
country: Venezuela
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06580860: Psychiatric Multi-omics and Neuroimaging Project
Official title: Psychiatric Multi-omics and Neuroimaging Project Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mental Disorders
Healthy Control
Keywords: schizophrenia
major depressive disorder
autism spectrum disorder
bipolar disorder
magnetic resonance imaging
multi-omics
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 1899
Sex: ALL
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from inpatient and outpatient the second Xiangya Hosptial of Central South University, Healthy controls from community, school and street recruitment

Brief summary: This study focuses on the structure and function of the brain and gene expression in peripheral blood of patients with schizophrenia, to explore the interaction and influence between the three. Patients with mental disorders who have been recruited will take their medication regularly for 1 year and participate in baseline and follow-up assessments.

Detailed description: The study seeks to identify possible biological markers of schizophrenia and the effects of gene-environment interactions on brain structural and functional networks. So we can help doctors and scientific researchers better understand the neuropathological basis of schizophrenia.

Eligibility criteria: Inclusion Criteria:

* Age: 13-35 years old(Patients with healthy siblings can be extended to 14-35 years of age)
* Course of disease: \<24 months
* Priority is given to patients who have never taken medicine or duration of drug use \< 2 weeks
* No nuclear magnetic contraindications.

Exclusion Criteria:

* Family history of psychotic disorders, history of psychoactive substances abuse, alcohol dependence, or nicotine dependence
* Have a major physical disease or infectious disease
* History of coma and serious neurological disease 4.MRI contraindications.

Primary outcomes:
measure: cortical morphology
timeFrame: 40 minutes
measure: target gene charaacteristics
timeFrame: 1 day
measure: scale scores
timeFrame: 90 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya hospital of central south univerity
state: Hunan
Study officials:
References:
Clinical trial NCT04422860: Remineralization Efficacy of Gum Arabic Varnish.
Official title: Remineralization Efficacy of Gum Arabic Varnish Versus Fluoride Varnish and CPP-ACP With Fluoride Based Varnish on Initial Carious Lesions. a Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Caries,Dental
Remineralization
White Spot Lesion
Keywords: Initial carious lesion
Gum Arabic
Remineralization power
fluoride varnish
Mi varnish
Acacia senegal
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 90
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the remineralizing capacity of Gum Arabic varnish and its implementation into clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients with initial carious lesions.
* Proper Oral hygiene.

Exclusion Criteria:

* Patients with a compromised medical history.
* Patients with active severe periodontal disease.
* Patients with hypoplastic or hypomineralized teeth.

Primary outcomes:
measure: Remineralization through determination of lesion progression or regression
timeFrame: Change from baseline at 3,6, 9 months
Secondary outcomes:
measure: Caries lesion activity assessment
timeFrame: Change from baseline at 3,6, 9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Lecturer at faculty of Dentistry- Cairo University
name: Rawda H. A.ElAziz, Post Phd
role: STUDY_DIRECTOR
affiliation: Assistant Professor at faculty of Dentistry- Cairo University
name: Rasha R Hassan
role: STUDY_CHAIR
affiliation: Master's Degree student at faculty of Dentistry- Cairo University
name: Ahmed H. Samaha, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Philip N. State of the Art Enamel Remineralization Systems: The Next Frontier in Caries Management. Caries Res. 2019;53(3):284-295. doi: 10.1159/000493031. Epub 2018 Oct 8.
citation: Onishi T, Umemura S, Yanagawa M, Matsumura M, Sasaki Y, Ogasawara T, Ooshima T. Remineralization effects of gum arabic on caries-like enamel lesions. Arch Oral Biol. 2008 Mar;53(3):257-60. doi: 10.1016/j.archoralbio.2007.10.004. Epub 2007 Nov 26.
Clinical trial NCT02437760: The Prognostic and Predictive Value of the CA-125 Marker in Lung Cancer Monitoring
Official title: Determination of the Prognostic and Predictive Value of the Cancer Antigen-125 (CA-125) Marker in Lung Cancer Monitoring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with histologically proved lung cancer

Brief summary: The tumor associated CA-125antigen for diagnosis and follow-up of ovarian cancer was well defined. Increased serum CA125 level may have many diagnoses other than ovarian cancer, including breast, colorectal and lung cancer. 80% lung cancer patients were diagnosed at advanced stage. Malignant pleural effusion secondary to lung cancer represented the condition of cancer cell involved pleura.

The CA-125 level may reflect the extent of tumor involved in pleura (tumor burden), it could be correlated with the prognosis. This study was performed to examine the properties of CA-125 by measuring pleural and blood CA-125 levels in lung cancer with or without malignant pleural effusion; meanwhile to examine whether the rate of decline in CA 125 during primary therapy as a surrogate indicator for survival.


Eligibility criteria: Inclusion Criteria:

* Histologically proved lung cancer

Exclusion Criteria:

* History of other cancers within the past 5 years
* Pregnancy or breast milk feeding
* TB pleuritis and peritonitis

Primary outcomes:
measure: The diagnostic Value of the cancer antigen-125 in lung cancer
timeFrame: 12months
Secondary outcomes:
measure: The prognostic value of the cancer antigen-125 in lung cancer
timeFrame: 24 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-DA hospital
Study officials:
References: