louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04099212: 15% TOPICAL RESORCINOL FOR HURLEY I-II HIDRADENITIS SUPPURATIVA.
Official title: OBSERVATIONAL CASE-ONLY PROSPECTIVE STUDY OF EFFECTIVENESS AND SAFETY OF 15% TOPICAL RESORCINOL FOR ADULTS WITH HURLEY I-II HIDRADENITIS SUPPURATIVA.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HYDRADENITIS
Keywords: RESORCINOL
HIDRADENITIS SUPPURATIVA
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that suffer from Hs Hurley I-II from the Andalusian Public Health System that are been follow up by the Dermatology Unity of Clinical Management of the HUVM.

Brief summary: Prospective, observational cross-sectional study to evaluate the response of patients with HS I-II to monotherapy treatment of topical resorcin 15%, taking into account its safety, impact on quality of life and subclinical evolution.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* Diagnosed with HS Hurley I-II degree.
* Patients that have at least 1 or more swollen up nodules and/or abscess.
* Availability of affected region control ultrasound prior to resorcine treatment beginning.

Exclusion Criteria:

* Age \< 18 years.
* Number of draining fistula above 20.
* Patients in active treatment with immunomodulators.
* Patients in active treatment with antibiotics.

Primary outcomes:
measure: Evaluate the change in the disease severity
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Usage profile
timeFrame: Initial
measure: Evaluate the security of the treatment
timeFrame: Up to 16 weeks
measure: Evaluate the changes in the patient´s quailty of life due to the treatment
timeFrame: Up to 16 weeks
measure: Evaluate the changes in the patient´s quailty of life due to the treatment 2
timeFrame: Up to 16 weeks
measure: Total and partial ultrasound responders frequency of distribution.
timeFrame: Up to 16 weeks
measure: Evaluate the frequency of responders
timeFrame: Up to 16 weeks
measure: Evaluate the change in the disease severity.
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: David Moreno Ramírez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04304612: A Cost Effective and Time Saving Blood Test to Detect Six Human Bloodborne Infectious Diseases
Official title: A Cost Effective and Time Saving Blood Test to Detect Six Human Bloodborne Infectious Diseases (SAFE-Blood)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV
Viral Hepatitis
Keywords: Serological assays
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Collection of human biological samples integrated into the laboratory's declared collections. These samples come from major subjects taken as part of a diagnostic or monitoring procedure for infection with viral hepatitis or HIV

Brief summary: The consortium will develop a new in vitro diagnostic (IVD) test to screen donated blood for bloodborne infectious pathogens, saving blood banks time and costs required for analysis of mandatory pathogens. The IVD test is a multiplex immunoassay that simultaneously screens for six bloodborne infectious diseases per blood sample. In this project, a mix of diagnostic protein markers will be developed and validated to lowdown an IVD test ready for commercial scale-up and CE-IVD certification.


Eligibility criteria: Inclusion criteria:

- Samples having been tested positive or negative for the serological markers explored in the study

Exclusion criteria:

- to refuse to participate to the study

Primary outcomes:
measure: Number of Analytical performances
timeFrame: day 1
Secondary outcomes:
measure: Number of Field evaluation
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Edouard TUAILLON
role: STUDY_DIRECTOR
References:
Clinical trial NCT06634212: The Dubousset Functional Test in Total Knee Arthloplasty
Official title: Validity and Reliability of Dubousset Functional Test in Total Knee Arthloplasty
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Knee Arthroplasty
Lead sponsor: Alanya Alaaddin Keykubat University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 50-70 years who had Total Knee Arthroplasty

Brief summary: The aim of this study is to investigate the validity and reliability of Dubousset Functional Test in the patients with Total Knee Prothesis.


Eligibility criteria: Inclusion Criteria:

* Patients who had Total Knee Arthroplasty
* Patients aged 50-70 years.

Exclusion Criteria:

* Patients who didn't have any Total Kne arthroplasty
* hose with fractures, pregnancy, a disease that would prevent physical exertion, those with a body mass index (BMI) of 40 kg/m2 and above, and those with major musculoskeletal or neurological disorders that cause gait disturbance will be excluded from the study.

Primary outcomes:
measure: Dubousset Functional Test
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03034512: Alpers Huttenlocher Natural History Study
Official title: Natural History Study of Alpers Huttenlocher Syndrome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alpers Huttenlocher Syndrome
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2017-01-27
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Alpers Huttenlocher Syndrome (AHS) and their siblings

Brief summary: This is a natural history study of Alpers Huttenlocher Syndrome. Patients will be followed over time to assess clinical symptoms for the purpose of expanding knowledge of this disorder in the medical community.

Detailed description: The study team will conduct outpatient visits to the medical center on a 6 month basis, or as patients are able. The patients or their caregivers will complete medical and symptom questionnaires.

Eligibility criteria: Inclusion Criteria:

* All individuals of any age with confirmed Alpers Huttenlocher Syndrome (AHS) or siblings of confirmed AHS patients are eligible to participate. AHS requires the presence of polymerase gamma 1 (POLG) pathological mutations, either homozygous or compound heterozygote mutations, and the presence of epilepsy and either, developmental regression or hepatopathy. If POLG mutations are not demonstrated, AHS requires the presence of refractory seizures, developmental regression, and hepatopathy as well as two or more other clinical and laboratory findings including elevated cerebrospinal fluid (CSF) protein, neuroimaging showing lactate peaks, reduced N-acetyl aspartate with hyperintensities on T2/FLAIR in the thalamus and posterior head regions, optic atrophy/cortical blindness, quantitative mtDNA reduction (\>30% ) in muscle and/or liver, non-specific electron transport chain (ETC) enzyme deficiencies.
* All patients must agree to participate in the North American Mitochondrial Disease Consortium (NAMDC) Clinical Registry

Exclusion Criteria:

* Patient does not have confirmed AHS and is not the sibling of a patient with confirmed AHS
* Not willing to participate in the NAMDC clinical Registry

Primary outcomes:
measure: onset age
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
city: Seattle
country: United States
facility: Seattle Childrens Hospital
state: Washington
Study officials:
affiliation: Columbia University
name: Michio Hirano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital
name: Russell Saneto, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02599012: The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cancer
Anemia
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple.
* Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment.
* Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.
* In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.


Eligibility criteria: Inclusion Criteria:

* Subjects who diagnosed with solid cancer or lymphoma
* Subjects who are under anti-cancer therapy at enrollment or has finished anti-cancer therapy within 2 months before enrollment

  * anticancer therapy: "chemotherapy", and/or "chemotherapy + radiotherapy", and/or "target agent"
* Subjects whose Hb level is 8.0-10.5g/dL, or who experienced a drop of Hb by 2g/dL or more during anti-cancer treatment

Exclusion Criteria:

* Subjects who received iron (oral or iv), ESA, dialysis within 4 weeks before enrollment
* Subjects with uncontrolled infection
* Subjects with ongoing bleeding
* Deteriorated organ function
* poor performance state (ECOG 3-4)
* Subjects whose disease involves bone marrow
* Ferritin \> 800 ng/ml and Transferrin saturation(TSAT) ≥ 50%

Primary outcomes:
measure: Number of participants with Hemoglobin response
timeFrame: visit 4th after Ferinject injection
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Irwon-ro ,Kangnam-gu
Study officials:
References:
citation: Jang JH, Kim Y, Park S, Kim K, Kim SJ, Kim WS, Jung CW, Lee J, Lee SH. Efficacy of intravenous iron treatment for chemotherapy-induced anemia: A prospective Phase II pilot clinical trial in South Korea. PLoS Med. 2020 Jun 8;17(6):e1003091. doi: 10.1371/journal.pmed.1003091. eCollection 2020 Jun.
Clinical trial NCT05830812: Improving the Intraoperative Diagnosis Accuracy of Invasiveness for Small-sized Lung Adenocarcinoma
Official title: Improving the Intraoperative Diagnosis Accuracy for Pre-invasive and Invasive Small-sized Lung Adenocarcinoma Node by Combining Multi-modal Information
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Adenocarcinoma, Stage I
Keywords: multi-modal information
lung adenocarcinoma
intraoperative diagnosis
invasiveness
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2018 to December 2022, about 3000 patients with lung adenocarcinoma were enrolled in this retrospective study.

Brief summary: The goal of this observational study is to improve the intraoperative diagnosis accuracy of invasiveness for small-sized lung adenocarcinoma by combining multi-modal information. The main question it aims to answer is whether multi-modal information have great value of prediction on the invasiveness for small-sized lung adenocarcinoma. Since a promising limited resection is largely based on intraoperative frozen section diagnosis, there is a growing demand on the high-accuracy of timely pathology diagnosis. The multi-modal information of participants will be collected retrospectively.


Eligibility criteria: Inclusion Criteria:

CT examination within 3 months before surgery Patients with operable clinical stage I lung cancer No previous treatment in the lungs or any other organ

≥ 20 years and ≤ 80 years old Tumor less than 3cm in diameter on thin-slice (0.625-1 mm) CT images Lung adenocarcinoma confirmed by surgical resection and histopathological diagnosis

Exclusion Criteria:

Marked artifacts on CT images History of preoperative treatment Incomplete clinical information or DICOM images History of other malignant tumors Lung cancer associated with cystic airspaces

Primary outcomes:
measure: Final pathology diagnosis of the paraffin section stained with HE
timeFrame: Immediately after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Yang Jin, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05682612: Prognostic Value of PtcO2 in Patients With COVID-19
Official title: Prognostic Value of Transcutaneous Partial Pressure of Oxygen in Patients With Novel Coronavirus Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Keywords: ARDS
respiratory failure
COVID-19
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients

Brief summary: Five percent of patients with COVID-19 progressed to respiratory failure and required ICU admission, such patients often have abnormal oxygen tolerance. However, there is still a lack of clinical indicators to predict the prognosis and treatment responsiveness of COVID-19.

Detailed description: Five percent of patients with COVID-19 progressed to respiratory failure and required ICU admission. Attention should be paid to patients over 65 years of age who have severe underlying diseases (cancer, respiratory diseases, cardiovascular and cerebrovascular diseases, chronic renal failure, autoimmune deficiency diseases, etc.) and have not completed the whole course of vaccine, and such patients often have abnormal oxygen tolerance, that is, a significant decrease in skin finger pulse oxygen saturation (SpO2) can occur after daily activities. Basal SpO2 at admission is often associated with prognosis, but it is difficult to differentiate prognosis from responsiveness to treatment by changes in SpO2 after oxygen therapy is administered clinically. However, there is still a lack of clinical indicators to predict the prognosis and treatment responsiveness of COVID-19.

Eligibility criteria: Inclusion Criteria:

* Age: 18-80 years, male or female; Patients with COVID-9 pneumonia (typical imaging features of COVID-19 pneumonia) (oxygen saturation ≤ 93% during air or arterial partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) ≤ 300 mmHg at rest)；

Exclusion Criteria:

* Pregnant or lactating women; Patients who refuse to undergo transcutaneous tissue oxygen pressure monitoring; Clinicians believe that patients are not appropriate; Patients undergoing ECMO.

Primary outcomes:
measure: Level of Transcutaneous partial pressure of oxygen
timeFrame: up to 30 days
Secondary outcomes:
measure: Level of Transcutaneous partial pressure of oxygen/FiO2
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda hospital
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Jingyuan Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01842412: The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication
Official title: The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intermittent Claudication
Keywords: Mitochondria, Muscle
Exercise
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient clinic, vascular surgery, Trondheim, Norway

Brief summary: The hypothesis of this study is that one bout of leg exercise gives acute qualitative changes in mitochondrial function in claudication. Final purpose is to determine the optimal exercise frequency in treatment of claudication.


Eligibility criteria: Inclusion Criteria:

* A history of any type of uni- or bilateral exertion leg pain.
* A maximal claudication distance that is less than 300 meter
* Diagnosed with intermittent claudication secondary to vascular insufficiency
* An ankle-brachial index between 0.4 and 0.9.
* Lives in Trondheim

Exclusion Criteria:

* Diagnosed with critical limb ischemia
* ankle-brachial index \> 0.90 or \< 0.4
* Limited exercise tolerance
* Warfarin or heparin usage
* Diabetes mellitus
* Underwent a vascular intervention in the last 3 months
* Active cancer, renal- or liver disease.

Primary outcomes:
measure: Mitochondrial function
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department for circulation and medical imaging, NTNU
state: Postboks 8905
Study officials:
affiliation: Norwegisn University of Science and Technology
name: Øyvind Ellingsen, prof
role: STUDY_DIRECTOR
References:
citation: van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson EJ. Mitochondrial Respiration after One Session of Calf Raise Exercise in Patients with Peripheral Vascular Disease and Healthy Older Adults. PLoS One. 2016 Oct 19;11(10):e0165038. doi: 10.1371/journal.pone.0165038. eCollection 2016.
Clinical trial NCT04550312: The Impact of Lifestyle Changes on Non-COVID Deaths
Official title: The Impact of Lifestyle Alteration by Strict Prevention Measures on Non-COVID Deaths in the Region With Low COVID-19 Transmission Rate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lifestyle Alteration
Non-COVID Deaths
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 80000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all cases of non-Covid-19 deaths in Xuzhou region between 2018 and 2020

Brief summary: The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. In such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-COVID-19 deaths. Yet, there has no thorough investigation in this aspect.

Detailed description: Background The increase of all-cause mortality in the areas with high COVID-19 transmission rate due to COVID-19 deaths and the collateral damage to other healthcare problems is well known. However, the COVID-19 mortality is very low in the regions with low transmission rate and sufficient medical resources. In such regions, strict prevention measures were taken and these would alter the people's lifestyle and hygienic habits and further impact on non-COVID-19 deaths. Yet, there has no thorough investigation in this aspect.

Methods The number of registered deaths among 8.8 million permanent residents with specific causes from January 2018 to June 2020 were sourced from the Xuzhou Center for Disease Control and Prevention, Jiangsu Province, China. Death rates were calculated and compared by weeks, months, and years with a focus on the period of COVID-19 pandemic from Jan 24 to March 27, 2020. Numeric values of all-cause death and the death rates of non-COVID diseases were compared in time series at different time scales.

Eligibility criteria: Inclusion Criteria:

* All cases of death reported to the Xuzhou CDC during the study period

Exclusion Criteria:

* no

Primary outcomes:
measure: Numeric values of all-cause death and the death rates of non-COVID diseases
timeFrame: from January 2018 to June 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Xuzhou Medical University affiliated Hospital
state: Jiangsu
Study officials:
affiliation: Xuzhou Medical University affiliated hospital
name: minglong chen, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00467012: Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer
Official title: Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: Inoperable metastatic breast cancer
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2007-04-27
Enrollment: 122
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.


Eligibility criteria: * At least 20 years old and obtained a written informed consent
* Advanced breast cancer (StageⅣ) or Inoperable metastatic breast cancer
* HER2 negative
* At least one measurable lesion based on RECIST criteria
* No previous chemotherapy for metastatic breast cancer

Primary outcomes:
measure: Safety
timeFrame: throughout study
measure: Progression-free survival (PFS)
timeFrame: event driven
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: event driven
measure: Time to Treatment Failure(TTF)
timeFrame: evnt driven
measure: Response Rate(RR)
timeFrame: event driven
Other outcomes:
Locations:
city: Kanto
country: Japan
facility: Kanto Region
city: Kinki
country: Japan
facility: Kinki Region
city: Kyushu
country: Japan
facility: Kyushu region
city: Sikoku
country: Japan
facility: Sikoku region
city: Tohoku
country: Japan
facility: Tohoku region
Study officials:
affiliation: Clinical research department 3
name: Shingo Koganezawa
role: STUDY_CHAIR
References: