louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06147102: The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study
Official title: The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Aneurysm
Keywords: intracranial aneurysm
surgery
neurosurgery
endovascular
interventional neuroradiology
neurointervention
unruptured
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 173
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing endovascular or surgical treatment for an unruptured intracranial aneurysm at Helsinki university hospital

Brief summary: A research-initiated prospective cohort study with the aim to assess the effectivity, safety and long-term outcomes after surgical and endovascular treatment of unruptured intracranial aneurysms. All consecutive patients with a non-ruptured intracranial aneurysms treated at Helsinki University Hospital will be included. Safety is measured by postoperative magnetic resonance imaging (MRI) taken 1-3 days after the treatment, treatment-related complications and functional outcome at three months. Effectiveness is measured by angiographic results and assessment of long-term bleeding from the treated aneurysm. Other outcomes include risk of developing epilepsy, getting a new stroke, and dementia on long-term follow-up.


Eligibility criteria: Inclusion Criteria:

* All patients with an unruptured intracranial aneurysm undergoing treatment

Exclusion Criteria:

* Arteriovenous malformation related intracranial aneurysm
* Moyamoya-disease related intracranial aneurysm
* Ruptured intracranial aneurysm

Primary outcomes:
measure: New ischemic lesion on postoperative MRI
timeFrame: 1-3 days
Secondary outcomes:
measure: Neurological symptom
timeFrame: 3 months
measure: Return to work
timeFrame: 3 months
measure: Functional outcome
timeFrame: 3 months
measure: Aneurysm occlusion on angiography
timeFrame: 6mo - 5yrs
measure: Patients with late rebleeding from the target aneurysm
timeFrame: up to 10 yrs
measure: Epilepsy
timeFrame: up to 10 yrs
measure: Dementia
timeFrame: up to 10 yrs
measure: Other stroke than aneurysm bleed
timeFrame: up to 10 yrs
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Rahul Raj, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02435602: The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers
Official title: The Role of Narrow Band Imaging (NBI) Endoscopy Compared With Lugol Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Squamous Cell Carcinoma
Squamous Cell Carcinoma of the Head and Neck
Keywords: endoscopy, gastrointestinal
cancer screening
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Centre of Postgraduate Medical Education
First posted: 2015-05-06
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study evaluates the role of narrow band imaging (NBI) endoscopy compared with Lugol chromoendoscopy in the early detection of esophageal cancer in patients with prior head and neck cancers.

Detailed description: Patients with head and neck cancers have an increased risk for developing an esophageal squamous cell carcinoma (ESCC). Small, superficial, curable lesions are difficult to diagnose using only white light endoscopy. To improve detection chromoendoscopy is recommended. In this project patients are divided into two groups based on received chromoendoscopy (NBI versus Lugol). The results of two methods will be compare regarding positive predictive value to establish usage of chromoendoscopy in early detection of ESCC.

Eligibility criteria: Inclusion Criteria:

* Patients with past history ( \>= 1 year ) of head and neck cancer treated curatively and receiving regular follow - up at the outpatient clinic of the Head and Neck Department of Maria Skłodowska - Curie Memorial Cancer Center, Institiut of Oncology
* 18 years and older
* Diagnosis of squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
* Zubrod scale 0-2
* Provided written informed consent

Exclusion Criteria:

* Lack of written informed consent
* Known allergy to iodine
* Clinical conditions precluding upper GI endoscopy

Primary outcomes:
measure: Positive predictive value
timeFrame: 2 years
Secondary outcomes:
measure: Duration of the esophagoscopy ( NBI versus Lugol staining)
timeFrame: 2 years
measure: Evaluation of endoscopy ( NBI versus Lugol staining) tolerance using Visual Analogue Scale (VAS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Maria Sklodowska-curie Memorial Cancer Center, Institiute of Oncology
Study officials:
affiliation: Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland
name: Jaroslaw Regula, PhD
role: STUDY_DIRECTOR
affiliation: Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland
name: Anna Chaber-Ciopinska, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04359602: COVID-19 Recovered Volunteer Research Participant Pool Registry
Official title: COVID-19 Recovered Volunteer Research Participant Pool Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Recovered From COVID-19
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 5090
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People volunteering to share their information to become part of this research pool of COVID-19 recovered individuals will complete an online survey.

Brief summary: This is a prospective observational registry of COVID-19 recovered patients who are no longer symptomatic. This Registry is intended to serve as a pool of individuals that can participate in studies associated with serological testing, characterization of immunity and immune response, vaccine development, and convalescent plasma donors.


Eligibility criteria: Inclusion Criteria:

* All patients seen the in emergency room, admitted patients, or seen in outpatient clinics that are:

  * Tested Positive for COVID-19 and recovered
  * Suspected to have COVID 19 and validated with serological testing
  * Suspected to have COVID 19 by symptoms, clinical course, and laboratory testing ruling out other respiratory viral disease

Primary outcomes:
measure: Serological testing of COVID patients
timeFrame: Up to 20 years
measure: Immune response
timeFrame: Up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Arash Naeim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01667302: Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma
Official title: A Phase II Study of Radiotherapy Followed by Chemotherapy With DICEP Regimen in Patients With NK/T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
Keywords: NK/T-cell lymphoma
Radiotherapy
Adjuvant chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.

Detailed description: For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and chemotherapy is controversial. Some studies demonstrated the advantage of upfront radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.

Eligibility criteria: Inclusion Criteria:

* Age range 14-70 years old
* Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Without prior history of pancreatitis
* Adequate bone marrow and organ functions

Exclusion Criteria:

* Low risk population (Definition: stage I without local invasion, B symptoms and high LDH level)
* Pregnant or lactating women
* With contraindication of steroid including uncontrolled diabetes
* Serious uncontrolled diseases and intercurrent infection
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Primary outcomes:
measure: 3-year Progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall response rate
timeFrame: 3 years
measure: 3-year overall survival
timeFrame: 3 years
measure: Safety
timeFrame: 3 years
Other outcomes:
Locations:
city: SHanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ye Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu Y, Xue K, Xia Z, Jin J, Wang J, Sun H, Lv F, Liu X, Cao J, Hong X, Guo Y, Ma X, Zhang Q. Radiotherapy followed by DICEP regimen in treatment of newly diagnosed, stage IE/IIE, extranodal NK/T-cell lymphoma patients. Cancer Med. 2020 Aug;9(15):5400-5405. doi: 10.1002/cam4.3207. Epub 2020 Jun 9.
Clinical trial NCT00210002: Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced
Official title: Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neoplasms
Anemia
Keywords: Neoplasms
Solid
Anemia
darbepoetin alfa
ferric saccharose
Venofer®
Aranesp®
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 55
Sex: ALL
Minimum age (years): 18
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 evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic treatment or by association of Darbepoetin alfa -ferric saccharose systematic supplementation, administered concomitantly with chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Well-informed written consent, signed by the patient
* Patient picked up for solid tumor treatment, whichever the localization, with or without metastasis
* Patient revealing, before or during chemotherapy, a moderate anemia, that means: Men: 9\<Hb\<12 g/dl; Women: 9\<Hb\<11 g/dl.
* Patient for who at least four chemotherapy cycles are planed (eight in case of weekly chemotherapy) after inclusion in the study
* Patients with life expectancy higher than three months
* Patient with general conditions compatible with the study's follow-up

Exclusion Criteria:

* Contra-indication for Venofer
* Anemia which can have curative treatment
* Bloody transfusion during the previous four weeks
* Documented or suspected medullary invasion
* Uncontrolled arterial hypertension
* Acute bacterial infection
* Transferrin saturation's coefficient
* Pregnancy
* Ferric salts oral treatment interrupted since less than one week
* Patient with bad french language's comprehension
* Patient with a major psychiatric pathology
* Patient under guardianship, trusteeship or justice safeguard

Primary outcomes:
measure: Biological response rate for each group.
Secondary outcomes:
measure: To determine tolerance for ferric saccharose (Venofer®)
measure: To determine percentage of patients who necessitate an increase of Darbepoetin alfa's dose(Aranesp®)
measure: To determine percentage of hemoglobin rate's correction
measure: To determine biological parameters's evolution
Other outcomes:
Locations:
city: Castres
country: France
facility: Centre Hospitalier de Castres
city: Montauban
country: France
facility: Centre Hospitalier de Montauban
city: Toulouse
country: France
facility: Centre Hospitalier Joseph Ducuing
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Institut Claudius Regaud
name: Roland Dugat, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01213602: Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery
Official title: Bilateral Bispectral Index Changes During Knee Replacement Surgery With and Without Femoral Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Replacement Surgery
Keywords: Trauma patients
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2010-10-04
Enrollment: 85
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA physical status I-III patients scheduled for total knee arthoplasty

Brief summary: The principal objective is to notice the relevance of timing performance of femoral block for knee replacement surgery during general anesthesia and analyze the relationship with bilateral bispectral index (BIS) monitoring during induction and maintenance of anesthesia. Otherwise the investigators try to investigate if the timing of performance of this block influence in postoperative variables as pain or blood loss.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

ASA IV, patients with difficult airway management, patients with antecedent of cerebral ischemia, presence of atrioventricular fistula, patients with absent distal pulses or history of vascular surgery in the involved limbs, patients with high risk of deep vein thrombosis.-

Primary outcomes:
measure: Sevoflurane requirements
timeFrame: 6 months
Secondary outcomes:
measure: Intraoperative and postoperative opiates requirements and relations with CVI
timeFrame: Time surgery and 24,48 and 72 h postoperative
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Antoni Sabate Pes
state: Barcelona
Study officials:
affiliation: Hospital Universitari Bellvitge
name: Antoni Sabate Pes, MD PhD DEEA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05173402: Treating Gnathic Form of Mesial Occlusion in Early Adolescence Patients
Official title: Treating Gnathic Form of Mesial Occlusion in Early Adolescence Patients: A Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gnathic (Skeletal) Mesial Occlusion
Keywords: early adolescence
orthodontic practice
orthodontic treatment
Lead sponsor: The 108 Military Central Hospital
Sponsor class: OTHER_GOV
First posted: 2021-12-29
Enrollment: 46
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: To evaluate the early and late results of the non-surgical orthopedic treatment efficiency in 12-14 years old children with the gnathic forms of mesial occlusion by the dentoalveolar compensation utilizing a permanent device with a palatal expanding screw.

Brief summary: The primary purpose of this study was to evaluate the immediate and previous results of the effectiveness of non-surgical orthopedic treatment in children aged 12-14 years with gnathic forms of mesial occlusion by the method of dentoalveolar compensation using a permanent apparatus with a palatal expanding screw.


Eligibility criteria: Inclusion Criteria:

patients with a gnathic (skeletal) mesial occlusion patients age 12-14 years patients who underwent orthopedic treatment

Exclusion Criteria:

change of residence severe form of gnathic mesial occlusion congenital anomalies of the dento-maxillo-facial area

Primary outcomes:
measure: dentoalveolar compensation method
timeFrame: 2014-2020
measure: face mask
timeFrame: 2014-2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01421602: A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia
Official title: A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Inguinal
Keywords: Inguinal Hernia
Self-fixating mesh
Progrip
Hernia Recurrence
Mesh, Surgical
Recurrence
Lead sponsor: De La Salle University Medical Center
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Potential study subjects will be patients who are:

18 - 80 years old; Has confirmed with the informed consent; Has a primary inguinal hernia (either unilateral or bilateral) which is reducible and amenable to local or regional hernia repair

Brief summary: This study will hypothesize that the use of a self fixating lightweight mesh in open inguinal repair is feasible in the Philippine setting. It will result in a comparable recurrence rate as published for the traditional Lichtenstein approach.

Detailed description: The specific aim of this study is to assess the feasibility of using a self fixating lightweight mesh in open inguinal hernia under both under regional and local anesthesia in the Philippines. The primary endpoint of which is to assess the recurrence rate at 2 years (with an interim analysis 1 year after the procedure). Secondary endpoints would be to gather data with regards to postoperative pain, post operative surgical complications, wound healing complications, operating factors (mesh deployment time, total operating time), hernia factors (type and size of inguinal hernia).

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Informed consent
* Primary inguinal hernia suitable for open inguinal repair
* Reducible hernia

Exclusion Criteria:

* Incarcerated non reducible hernias
* Bleeding disorders
* Patients below 18 (lower age limit) and above 80 (upper age limit) years old
* Hernia defects of greater than 4 cm

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dasmarinas
country: Philippines
facility: De La Salle University Medical Center
state: Cavite
Study officials:
affiliation: De La Salle University Medical Center - Department of Surgery
name: Michael M Lawenko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chastan P. Tension-free open hernia repair using an innovative self-gripping semi-resorbable mesh. Hernia. 2009 Apr;13(2):137-42. doi: 10.1007/s10029-008-0451-4. Epub 2008 Nov 13.
Clinical trial NCT03761602: The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease
Official title: The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease: a Prospective Registry Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iodine Excess in Pregnancy
Selenium Excess in Pregnancy
Iodine Deficiency in Pregnancy
Selenium Deficiency in Pregnancy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 290
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two hundred and ninety pregnant women with gestational age less than 20 weeks should be recruited in this study and will be followed up throughout the whole pregnancy.

Brief summary: Two hundred and ninety pregnant women with gestational age less than 20 weeks will be recruited in this study. Selenium and iodine conditions, and risk of thyroid disease will be monitored until termination of pregnancy, with pregnancy outcomes recorded.

Detailed description: The study will recruit 290 pregnant women with gestational age less than 20 weeks. Iodine and selenium condition will be evaluated through dietary recall (on base of Chinese food ingredient information) and biochemical examinations (serum iodine concentrations, urinary iodine concentrations, serum selenium concentrations, etc). The nutritional status of iodine and selenium will be monitored and followed up for all the included subjects throughout the pregnancy. The information of thyroid function and level of anti-TPO and anti-TG will be collected. And all the complications (especially thyroid disease) in pregnancy will also be recorded. All pregnant women will be followed up until the termination of pregnancy, with pregnancy outcomes recorded.

Eligibility criteria: Inclusion Criteria:

* Clinical confirmation of being pregnant.
* Being within less than 20 weeks of gestationa.

Exclusion Criteria:

* Being pregnant but over 20 weeks of gestationa.
* Mentally or psychologically unstable.

Primary outcomes:
measure: risk of thyroid disease
timeFrame: From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
measure: pregnancy outcomes
timeFrame: From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
Secondary outcomes:
measure: prevalence of other pregnant complications
timeFrame: From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months
measure: prevalence of thyroid disease in neonates
timeFrame: From date of birth to 4 weeks after birth
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01775202: Cognitive Changes After Fast-track Colon Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cogntive Changes After Surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly patients \> 60 years, undergoing fast-track colon surgery at Hvidovre Hospital during 2010-2012.

Brief summary: This descriptive study aims to evalaute in a retrospective way the incidence of cogntive changes postoperatively after fast-track colon surgery at Hvidovre Hospital. This survey is based on chart reviews.


Eligibility criteria: Inclusion Criteria:

* \> 59 years
* undergoing colon surgery at Hvidovre Hospital
* surgery and perioperative care in a fast-track setting

Exclusion Criteria:

Primary outcomes:
measure: cognitive change postoperatively based on chart review
timeFrame: during hospital stay (postoperative day 0-3)
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Dept. of abdominal surgery (colon section) Hvidovre Hospital
Study officials:
References: