louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01613183: Exploratory Study of Effective Core Formula of Chinese Medicine to Treat Primary Insomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Insomnia
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 2
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 objective of this study is to screen the effective core formulation in insomnia treatment with Chinese medicine with a double-blind, randomized, placebo-controlled trial.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 65 years,
* meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) of insomnia,
* Spiegel scale score is ≥ 18,
* The informed consent must be obtained from patient

Exclusion Criteria:

* total sleep time ≤ 2 hours,
* secondary insomnia,
* Self-rating Anxiety Scale (SAS) score ≥ 18,
* Beck Depression Inventory (BDI) score ≥ 6,
* having hypertension, diabetes, stroke, and coronary heart disease,
* have drug abuse history,
* pregnancy or preparing to pregnancy,
* used immunotherapy or hormone therapy in past 1 years,
* participating in another clinical trial.

Primary outcomes:
measure: change from baseline in Total Sleep Time (TST) at 4 weeks
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: change from baseline in sleep onset latency at 4 weeks
timeFrame: baseline and 4 weeks
measure: change from baseline in wake time after sleep onset at 4 weeks
timeFrame: baseline and 4 weeks
measure: change from baseline in sleep efficiency at 4 weeks
timeFrame: baseline and 4 weeks
measure: change from baseline in Pittsburgh sleep quality index (PSQI) at 4 weeks
timeFrame: baseline and 4 weeks
measure: change from baseline in Chinese Medicine symptoms and signs at 4 weeks
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen hospital, China Academy of Chinese Medical Sciences
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Liyun He, Doctor
role: STUDY_CHAIR
References:
citation: Yan S, Zhang R, Zhou X, Li P, He L, Liu B. Exploring effective core drug patterns in primary insomnia treatment with Chinese herbal medicine: study protocol for a randomized controlled trial. Trials. 2013 Feb 28;14:61. doi: 10.1186/1745-6215-14-61.
Clinical trial NCT01173783: Deutsches Device Qualitätsregister
Official title: Deutsches Device Qualitätsregister
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure
Cardiac insufficiency
Implantable Cardioverter/Defibrillator
Cardiac Resynchronization therapy
ICD
CRT
Register
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
First posted: 2010-08-02
Enrollment: 4008
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: all consecutive patients with an intended implantation of an ICD / CRT.

Brief summary: It is the aim of this register to document the development of therapies by implantation of Cardioverter/Defibrillators (ICDs) and/or Cardiac Resynchronization therapy (CRT)-Systems.

Detailed description: The possibility of evaluation of successes as well as of the complications of these therapies is needed to make quality management possible. Every German Center, implanting ICDs or CRT-devices, is encouraged to contribute to this register; data are collected by use of an electronical CRF.

Eligibility criteria: Inclusion Criteria:

* The Device register will include all consecutive patients with an intended implantation of an ICD / CRT.

Exclusion Criteria:

* Missing signed informed consent

Primary outcomes:
measure: Characterize consecutive patients with initial implantation of ICD or CRT in hospital daily routine in Germany
timeFrame: 01/03/2007-12/31/2011
Secondary outcomes:
measure: Specification of the device and the realization of the implantation as well as the success of the operation
timeFrame: 01/03/2007-12/31/2011
measure: Documentation of further interventions needed after the Index Event during hospital stay
timeFrame: 01/03/2007-12/31/2011
measure: Documentation of hospital mortality and non-fatal complications
timeFrame: 01/03/2007-12/31/2011
measure: Documentation of the 1-year mortality and non-fatal complications
timeFrame: 01/03/2007-12/31/2011
measure: Documentation of the dispensary of shocks within one year
timeFrame: 01/03/2007-12/31/2011
measure: Documentation of symptomatology and number of hospitalizations
timeFrame: 01/03/2007-12/31/2011
measure: Documentation of medication therapy after 12 months
timeFrame: 01/03/2007-12/31/2011
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Bielefeld
country: Germany
facility: Städtische Kliniken Bielefeld
city: Bonn
country: Germany
facility: St. Marien Hospital
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
city: Hamburg
country: Germany
facility: Asklepios Klinik St Georg
city: Karlsruhe
country: Germany
facility: St. Vincentius Klinikan AG
city: Villingen-Schwenningen
country: Germany
facility: Klinikum Villingen-Schwenningen
Study officials:
affiliation: Stiftung Institut fuer Herzinfarktforschung
name: Jochen Senges, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05160883: Neuroimaging Changes in Hereditary Ataxia
Official title: Neuroimaging Changes in Hereditary Ataxia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hereditary Ataxia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with hereditary ataxia

Brief summary: This study aim to investigate the neuroimaging changes of hereditary ataxia patients, especially in the SCA3 patients in preclinical or mild stage.


Eligibility criteria: Inclusion Criteria:

* genetically diagnosed as Spinocerebellar ataxia

Exclusion Criteria:

* deny to follow-up

Primary outcomes:
measure: neuroimaging information
timeFrame: from 2021 to 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital,Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT02824783: Quality of Life After Enhanced Recovery Protocol for Colorectal Surgery
Official title: Quality of Life and Satisfaction of Patients Discharged Home After Enhanced Recovery Protocol for Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: colorectal surgery
enhanced recovery
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients included in our GRACE database since the 1st of October 2015

Brief summary: The aim of the study is to investigate the quality of life and satisfaction of patient who underwent colorectal surgery using an enhanced recovery protocol when back home.

In this retrospective study patients will be telephoned and asked to answer a questionnaire.

Detailed description: Since October 1st 2015, our center has been labelled reference center for colorectal surgery using Enhanced Recovery Protocol (ERP) by GRACE (Groupe francophone de Rehabilitation après ChirurgiE; a francophone counterpart of ERAS® society). In case of ERP, the quality of life when the patient is at home is not well known. Some argue that patient might experience discomfort and lack of autonomy, particularly elderly patient if discharged home too quickly.

In this study, the investigators will call our patients introduced in the database of GRACE to assess the quality of life and patient satisfaction concerning our ERP. Eight domains will be investigated: information, stress, feelings when discharged home, pain, fatigue, autonomy, feeding problems, and satisfaction.

When analyzing the results the investigators will pay a particular attention to elderly patients (age \> 70 yo) to determine whether these experience more difficulties as compared to younger patients.

Eligibility criteria: Inclusion Criteria:

* all patients included in our GRACE database

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Quality of life (0 to ten numeric scale + questionnaire)
timeFrame: first month after leaving the hospital
Secondary outcomes:
measure: Satisfaction (0 to ten numeric scale + questionnaire)
timeFrame: first month after leaving the hospital
measure: Pain (0 to ten numeric scale + questionnaire)
timeFrame: first month after leaving the hospital
measure: Fatigue (0 to ten numeric scale + questionnaire)
timeFrame: first month after leaving the hospital
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: University Hospital of Liege
Study officials:
affiliation: Department of Anesthesiology, CHU Liege, Belgium
name: Jean Joris, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05786183: Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies
Official title: Diagnostic Accuracy of a Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies to Enable a Real Time Diagnosis of Celiac Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coeliac Disease
Keywords: intestinal antibodies
Rapid test
Coeliac disease
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 163
Sex: ALL
Minimum age (years): 1
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects included in the study will be children and young adults, between 1 to 22 years of age, referred to the Gastroenterology Unit for elective GIE

Brief summary: Intestinal Celiac Disease (CD)-antibodies have been described as the best marker to reveal progression toward villous atrophy and could become the diagnostic marker to make prompt diagnosis in the wide clinical spectrum of CD reducing the delay in diagnosis and treatment. The introduction of either anti-endomysial antibodies (EMA) assay or rapid anti-Transglutaminase 2 (TG2) test on supernatant of mechanically lysed biopsy samples in the clinical practice would improve the diagnosis of CD, especially in clinically challenging scenarios. The availability of an accurate test for identifying intestinal CD-antibodies that do not need the culture of intestinal biopsy is less expensive, less time consuming and easier to perform would facilitate the implementation of such technology outside research laboratories, and enable the diagnosis of CD at the end of Gastrointestinal Endoscopy (GIE).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing an elective esophagogastroduodenoscopy (EGD) for suspected CD, eosinophilic esophagitis, autoimmune enteropathy, inflammatory bowel disease, gastritis, gastric or duodenal ulcer, gastroesophageal reflux disease.

Exclusion Criteria:

* Bleeding disorders
* Patients fulfilling the new ESPGHAN Guidelines for diagnosing CD (version 2020), for a serology based CD diagnosis
* Subjects in whom intestinal biopsies are not indicated as part of the diagnostic process.

Primary outcomes:
measure: Diagnostic accuracy of EMA assay detected on supernatant of mechanically lysed intestinal biopsy specimens
timeFrame: At the time of endoscopic examination
measure: Diagnostic accuracy of rapid anti-TG2 test detected on supernatant of mechanically lysed intestinal biopsy specimens
timeFrame: At the time of endoscopic examination
Secondary outcomes:
measure: Concordance of EMA assay and rapid anti-TG2 test on supernatant of mechanically lysed intestinal biopsy specimens with Culture-EMA results
timeFrame: At the time of endoscopic examination
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
Study officials:
References:
Clinical trial NCT01809483: Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients
Official title: Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erosion; Cornea, Traumatic
Keywords: mechanical corneal erosion
bandage contact lens
pressure patching
erosion area
pain scale
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2013-03-12
Enrollment: 32
Sex: ALL
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research aims to compare between bandage contact lens and pressure patching in reducing size of erosion area and pain scale in corneal erosion patients as well as its complications.

Detailed description: This is a randomized open-label clinical trial in patients with mechanical corneal erosion. Subjects were selected to use bandage contact lens (Senofilcon A) or pressure patching. All subjects received combination of Polymyxin B, Neomycin, and Gramicidin eye drops and 0,5% Tropicamide eye drops. Evaluation was done 24 hours after treatment

Eligibility criteria: Inclusion Criteria:

* aged 17-55 years
* onset of corneal erosion \< 48 hours
* corneal erosion due to mechanical injury
* extensive corneal erosion \> 3 mm2

Exclusion Criteria:

* bilateral corneal erosion
* corneal erosion due to chemical or thermal injury
* history of systemic analgesic use within 1 week prior to the examination or topical analgesics within 1 hour before the examination
* history of systemic or topical antibiotics within 1 week prior to the examination
* other abnormalities due to trauma
* palpebral or eyelashes position abnormalities
* anterior segment infections
* tear break-up time \< 7 seconds in the contra lateral eye

Primary outcomes:
measure: Size of corneal erosion area
timeFrame: 24 hour
Secondary outcomes:
measure: Pain scale
timeFrame: 24 hour
Other outcomes:
measure: Complication
timeFrame: 24 hour
Locations:
city: Denpasar
country: Indonesia
facility: Depatment of Ophthalmolohy, Medical Faculty, Udayana University / Sanglah Public General Hospital
state: Bali
Study officials:
affiliation: Department of Ophthalmology, Medical Faculty Udayana University / Sanglah Public General Hospital
name: Ni Nyoman Triharpini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02430883: Is There Any Relation Between Pain and Stone Location in Retrograde Intrarenal Surgery?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nephrolithiasis
Keywords: pain, RIRS, kidney
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: We want to serach the relationship between the pain degree and stone localisation in kidney in Retrograde intrarenal surgery


Eligibility criteria: Inclusion Criteria:

* Patients undergoing RIRS Age between 18 and 90 years

Exclusion Criteria:

* Patients who have congenital urogenital abnormalities 2)Patients who have previous surgery history

Primary outcomes:
measure: Pain degree
timeFrame: Pain degree postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dıskapı TRH
Study officials:
References:
citation: Polito C, La Manna A, Signoriello G, Marte A. Recurrent abdominal pain in childhood urolithiasis. Pediatrics. 2009 Dec;124(6):e1088-94. doi: 10.1542/peds.2009-0825. Epub 2009 Nov 9.
Clinical trial NCT01333683: Tinnitus and Arterial Hypertension
Official title: Tinnitus and Arterial Hypertension.is There Any Relationship?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tinnitus
Hearing Loss
Arterial Hypertension
Keywords: tinnitus
hearing loss
arterial hypertension
ototoxicity
Lead sponsor: Faculdade de Medicina de Valenca
Sponsor class: OTHER
Collaborators: name: Federal University of São Paulo
First posted: 2011-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients agedd between 40 and 50

Brief summary: Many authors link tinnitus to arterial hypertension. The aim of this study is to establish a possible relationship between them, analyze the severity of tinnitus related to arterial hypertension and analyze a possible influence of ototoxic drugs used to treat arterial hypertension

Detailed description: Arterial hypertension has been cited as a possible tinnitus etiology. Vascular abnormalities associated with it may account for cochlear and central nervous system. However, a relationship between tinnitus and arterial hypertension has never been established. The aim of this study is to analyze this relationship, comparing groups with and without arterial hypertension and the incidence of tinnitus amongst them. Inclusion and exclusion criteria try to isolate arterial hypertension as the main etiological factor, as much as possible. Presbycusis, noise exposure, metabolical diseases and genetic factors will be ruled out. A comparison will be performed inside the arterial hypertension group between subgroups that use or not ototoxic medications, such as furosemide and beta-blockers

Eligibility criteria: Inclusion Criteria:

* age between 40 and 50
* arterial hypertension for group 1
* at least 5 years standing arterial hypertension

Exclusion Criteria:

* chronic noise exposure
* metabolic diseases
* family antecedents of hearing loss (except for presbycusis)
* pregnant women
* use of ototoxic drugs (except for anti-hypertensives)

Primary outcomes:
measure: Incidence of tinnitus - have tinnitus x don't have tinnitus
timeFrame: Up to 6 months
Secondary outcomes:
measure: Severity of tinnitus - Tinnitus Handicap Inventory
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Valença
country: Brazil
facility: Faculdade de Medicina de Valença
state: RJ
Study officials:
affiliation: Otosul, Valença Medical School
name: Ricardo R Figueiredo, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00465283: Donepezil Double Blind Trial for ECT Memory Disfunction
Official title: Donepezil Double Blind Trial for ECT Memory Disfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Keywords: Donepezil, ECT, Memory Disfunction
Lead sponsor: BeerYaakov Mental Health Center
Sponsor class: OTHER_GOV
First posted: 2007-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double blind randomized investigation of donepezil for patients suffering from schizophrenia, undergoing ECT.

Patients will be randomized to receive either donezepil or plasebo, in order to gauge whether donezepil has a protective effect on memory disfunction, while patients are treated with ECT. Several parameters will be invistigated at baseline: general psychopathological measures, memory function scales, side effects scales. The same measurements will be taken throughout the trial and one month after ending the ECT.


Eligibility criteria: Inclusion Criteria:

* Schizophrenia, Schizoaffective disorder, schizophreniform disorder patients who meet criteria for diagnoses by DSM-IV criteria and evaluated by the Structured Clinical Interview for DSM-IV (SCID)

Exclusion Criteria:

* History of serious neurological disorders including neurodegenerative deseases, mental retardation, substance and/or alcohol dependence.
* Pregnant women
* Patients who recieved ECT within 6 month
* Patients whith contraindication to Donepezil treatment.
* Patients with Lithium treatment

Primary outcomes:
measure: Data will be analyzed using SPSS for Windows.
timeFrame: after 5 ECT treatments
measure: Results of the memory and neurocognitive measures will be examined
timeFrame: after 8 ECT treatments
measure: using repeated MANOVA with before, within and after ECT treatment.
timeFrame: 1 month after the last ECT treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yaacov
country: Israel
facility: Beer Yaakov MHC
Study officials:
affiliation: Beer Yaakov Mental Health Center
name: Tali Nachshoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06616883: Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Study to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Single Administration of DA-5221_01 and Concomitant Administration of DA-5221_01-R1 and DA-5221_01-R2 Under Fasting Conditions in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* BMI between 18 and 30 kg/m2
* Body weight: Male≥50kg, Female≥45kg
* Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion Criteria:

* Subjects with clinically significant medical history
* Subjects with history of drug abuse or addicted

Primary outcomes:
measure: AUCt
timeFrame: pre-dose~72 hours post-dose
measure: Cmax
timeFrame: pre-dose~72 hours post-do
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bumin Hospital
state: South Korea
Study officials:
References: