louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05509764: The Effect of Oxygen Therapy on Atelectasis
Official title: Evaluation of Oxygen Threapy by Lung Ultrasound and Oxygen Reserve Index in Patients Undergoing Cesarean Section Under Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atelectasis
Cesarean Section
Hypotension
Keywords: Atelectasis
lung ultrasound
oxygen reserve index
cesarean section
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: parturients who underwent cesarean section under spinal anesthesia

Brief summary: In pregnancy, cephalal shift of the diaphragm caused by the enlarged uterus reduces the functional residual capacity and may increase the closure volume and predispose the pregnant woman to airway closure, leading to atelectasis. The development of atelectasis due to dermatomes retained in spinal anesthesia and intraoperative supine position may increase further. Oxygen therapy to be applied may also lead to absorption atelectasis by causing hyperoxia. The aim of our study is to evaluate the effect of oxygen support on the lungs in cesarean section operations under spinal anesthesia by lung ultrasound score and oxygen reserve index.


Eligibility criteria: Inclusion Criteria:

* 18-50 years old
* ASA I-II
* Patients scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

* alcohol or drug addiction, chronic obstructive pulmonary disease, cardiovascular disease, smokers anemia, liver or kidney disease, coagulation disorders allergic to anesthetic agents, sepsis or bacterial infection, body temperature is below 35°C and above 38°C Multiple pregnancy Preoperative hypoxemia SpO2\<94% Diabetes mellitus Hypertension Placenta previa Premature rupture of membranes Intrauterine growth retardation Preeclampsia-eclampsia-fetal distress Polyhydramnios Morbid obesity BMI\>45

Primary outcomes:
measure: atelectasis
timeFrame: during the surgery
Secondary outcomes:
measure: APGAR score
timeFrame: 1st and 5th min after delivery
measure: hypotension
timeFrame: during surgery
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Manolya Alkan
state: Kozlu
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Medicine Faculty
state: Kozlu
Study officials:
References:
Clinical trial NCT04056364: Diagnostic Value of Sputum Cytology in Asthma-COPD Overlap
Official title: Diagnostic Value of Sputum Cytology in Asthma-COPD Overlap
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD, Asthma,ACO
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients known have Asthma, COPD, ACO . age from 18 years until 75

Brief summary: The aim of this study is to evaluate the diagnostic value of sputum cell counts in differentiation between asthma, COPD and ACO.

to examine the relationship between sputum cell counts in bronchial revers¬ibility and bronchial hyperresponsiveness

Detailed description: Asthma and COPD are considered as chronic airway inflammatory diseases, which are typically associated with Th2-mediated immune response in asthma and related to the characteristics of Th1-mediated immunity in COPD . Asthma-COPD overlap (ACO) is the term to describe patients who have features of both asthma and COPD, recom¬mended by the 2019 Global Initiative for Asthma (GINA) and the Global Initiative for Chronic Obstruction Lung Disease (GOLD) guidelines. Patients with asthma and COPD are commonly seen in clinical practice. In addition, compared with patients with asthma or COPD alone, patients with ACO experience frequent exacerbations and hospitalizations, have poor quality of life, a more rapid decline in lung function and high mortality, and consume a disproportionate amount of health care resources than asthma or COPD alone .

Cell count in induced sputum is a noninvasive biomarker to assess airway inflammation phenotypes. Accordingly, sputum cell counts are extensively used in the treatment of asthma and COPD. Nevertheless, the clinical application of sputum cell counts in patients with asthma-COPD overlap (ACO) remains elusive .

Eligibility criteria: Inclusion Criteria:

* all patients known to be Asthma, COPD, ACO

Exclusion Criteria:

* Patients will be excluded if they have confounding pulmonary comorbidities, such as pulmonary tuberculosis, interstitial lung disease, lung cancer or pulmonary infection, and had a cognitive impairment that may affect the collaboration or comprehension of the study.

Primary outcomes:
measure: comparison of sputum cytology in Asthma , COPD, ACO
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ojanguren I, Moullec G, Hobeika J, Miravitlles M, Lemiere C. Clinical and inflammatory characteristics of Asthma-COPD overlap in workers with occupational asthma. PLoS One. 2018 Mar 2;13(3):e0193144. doi: 10.1371/journal.pone.0193144. eCollection 2018.
Clinical trial NCT02352064: Evaluation of the Diagnostic Value of PET (18F-FDG) in Chronic Graft Versus Host Disease (cGVH)
Official title: EVALUATION OF THE DIAGNOSTIC VALUE OF PET (18F-FDG) IN CHRONIC GRAFT VERSUS HOST DISEASE (cGVH)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Graft Versus Host Disease
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Allogeneic stem cell transplantation was developed to cure many patients with hematological malignancies. It results in the development of graft versus host disease (GVHD) in 30-70% of cases. Chronic GVHD diagnosis currently uses biopsies of affected organs (skin, liver, gastrointestinal tract) and / or the observation of typical clinical signs sufficient for diagnosis. However, the anatomical sites for biopsy including the digestive tract are not clearly identified (high or low biopsy) and may present risks in their realization in particular in patients weakened by blood disease or immunosuppression.

PET-CT with 18F-FDG has already been evaluated in chronic inflammatory diseases such as Crohns disease with good sensitivity and specificity. It interest in the graft against the host was studied in acute forms of digestive and allows lesion mapping and monitoring the effectiveness of treatment.

Among patients with chronic GVHD scleroderma form, PET with 18F-FDG enabled to view musculoskeletal uptakes localized to the affected areas identified with MRI.

The investigators propose a study evaluating the sensitivity and specificity of the examination by PET-CT with 18F-FDG in the diagnosis of chronic GVHD compared to conventional diagnostic tools.

Detailed description: Patients will have PET/CT at day 150+/-15d post-hematopoietic stem cell transplantation (HSCT)

Eligibility criteria: Inclusion Criteria:

* adult \>18 years
* Signed informed consent
* subject covered by a social security system
* Absence of contraindication to PET (18F-FDG)
* Allogeneic stem cell transplantation

Exclusion Criteria:

* Adult patient under tutelage.
* Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception
* Age\<18 years
* Evolutive infectious disease
* glycemia \>10mmol/L

Primary outcomes:
measure: Measure of sensibility and specificity of PET (18F-FDG) for cGVH diagnosis in comparison to standard care
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT05124964: Prospective Study on Quality of Life in Patients With Intracranial Germ Cell Tumors
Official title: Prospective Study on Quality of Life in Patients With Intracranial Germ Cell Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Keywords: intracranial germ cell tumors
quality of life
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed primary intracranial germ cell tumors are eligible for the study, including those diagnosed based on serum/cerebral spinal fluid tumor marker(s) elevation (β-HCG and/or AFP) and/or pathology.

Brief summary: The primary purpose of this study is to characterize the quality of life in patients with intracranial germ cell tumors. Those findings can contribute towards a better understanding of the impact of the current treatment strategy on survivors.

Detailed description: The characteristics of the quality of life in patients with intracranial germ cell tumors are far from understood. The main reason is the rare occurrence of the disease. As a result, most findings came from retrospective studies in which only dozens of patients participated. Generally, patients with intracranial germ cell tumors have a good prognosis, especially those with germinoma.

Over 90% of patients with germinoma will survival after ten years of follow-up. Thus, the quality of life in long-term survivors is of concern. The investigators designed this prospective study to address this issue to understand better the characteristics of the quality of life in patients with intracranial germ cell tumors and provide information for optimizing the current treatment strategy.

Eligibility criteria: Inclusion Criteria:

* 3 years ≤ age ≤ 21 years
* Newly diagnosed primary intracranial germ cell tumors
* Written informed consent

Exclusion Criteria:

* Relapsed disease
* Poor compliance

Primary outcomes:
measure: Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition)
timeFrame: Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment.
Secondary outcomes:
measure: Change of score of the QoL questionnaire (Short form-36)
timeFrame: Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment.
Other outcomes:
measure: Change of score of Chinese Wechsler Intelligence Scale for Children
timeFrame: Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment.
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Tao Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03280264: Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism
Official title: An Intra-Subject Dose-Adjustment Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism Who Are Unable to Undergo Parathyroidectomy or Relapse After Parathyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parathyroid Carcinoma
Primary Hyperparathyroidism
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-09-12
Enrollment: 18
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: To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.


Eligibility criteria: Inclusion Criteria:

* Personally submitted written voluntary informed consent to participate in the study
* Patients with a diagnosis of parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
* Corrected serum calcium level is \> 11.3 mg/dL at screening.

Exclusion Criteria:

* Patients receiving cinacalcet hydrochloride within 2 weeks before screening
* Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.
* Severe heart disease
* Severe hepatic dysfunction
* Uncontrolled hypertension and/or diabetes
* Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening

Primary outcomes:
measure: The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase.
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase.
timeFrame: up to 24 weeks
measure: Serum Corrected Ca Level
timeFrame: up to 52 weeks
measure: Serum Intact Parathyroid Hormone Level
timeFrame: up to 52 weeks
measure: Serum Whole Parathyroid Hormone Level
timeFrame: up to 52 weeks
Other outcomes:
Locations:
city: Ōsaka
country: Japan
facility: Osaka City University Hospital
Study officials:
References:
Clinical trial NCT01148264: Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis
Official title: Efficacy of Olanzapine in Break-through Emesis After Prophylaxis With Dexamethasone, 5-HT3 Receptor Antagonists and Aprepitant Compared to Metoclopramide
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Emesis
Keywords: break-through
emesis
break through emesis after prophylaxis with dexamethasone, 5-HT 3RA and aprepitant
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy. Efficacy will be assessed using a modified MASCC questionaire with a visual analog scale.


Eligibility criteria: Inclusion Criteria:

* break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy defined as vomitus or nausea\>25mm on VAS
* signed IC

Exclusion Criteria:

* psychiatric disorders
* drug abuse
* pregnancy
* high dose chemotherapy
* treatment with other antiemetic drugs

Primary outcomes:
measure: Clinical benefit rate
timeFrame: three days
Secondary outcomes:
measure: safety
timeFrame: five days
measure: Quality of life
timeFrame: 5 days
measure: change in urinary excretion of 5 hydroxy indole acetic acid
timeFrame: 5 days
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: Martin-Luther-University Halle-Wittenberg, Department for Oncology and Hematology, Ernst-Grube-Strasse 40
state: Sachsen-Anhalt
Study officials:
affiliation: Martin-Luther-University Halle-Wittenberg
name: Karin Jordan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00577564: EUS-CPN: A Retrospective Review
Official title: Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN): A Retrospective Review of Safety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-12-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that underwent a EUS-CPN over a ten year period at Indiana University Medical Center will be considered.

Brief summary: The purpose of this retrospective study is to measure the safety of EUS-CPN in patients that have undergone this procedure in the last decade.


Eligibility criteria: Inclusion Criteria:

* Any subject that has undergone EUS-CPN will be considered for this study.

Exclusion Criteria:

* Subjects will be excluded if they have undergone a celiac plexus neurolysis (endoscopic, percutaneous, or surgical) at an another institution.

Primary outcomes:
measure: Number of EUS-CPN procedures for each patient
timeFrame: over a ten year period
Secondary outcomes:
measure: Procedure-related complications
timeFrame: over a ten year period
Other outcomes:
Locations:
city: Indianpolis
country: United States
facility: Clarian: University Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Julia LeBlanc, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05274464: A Recurrence Nomogram for Hepatoid Adenocarcinoma of the Stomach
Official title: A Recurrence Nomogram to Guide Surveillance Strategies After the Resection of Hepatoid Adenocarcinoma of the Stomach: a China Hepatoid Adenocarcinoma of the Stomach Study Group Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Reurrence-free survival
Nomogram
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 261
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 with primary HAS who had undergone curative-intent resection at 14 institutions in China from 2004 to 2019 were included.

Brief summary: This study aims to develop a nomogram to predict postoperative recurrence of HAS and guide individually tailored surveillance strategies.

Detailed description: Patients were included from the China Hepatoid Adenocarcinoma of the Stomach Study Group (China-HASSG) database, which comprises 14 tertiary referral centers. All the patients who had undergone complete resection of a primary HAS between April 2004 and December 2019 were included. First, univariate analysis was performed in Cox regression to identify the risk factors associated with RFS. Next, variables with P\< 0.05 in univariable analysis were included in the multivariable model, and the forward likelihood ratio method was used for analysis to confirm the independent prognostic factors associated with RFS. Finally, based on the results of multivariable analysis, variables that achieved significance at P\< 0.05 were selected to formulate a nomogram.

Eligibility criteria: Inclusion Criteria:

* Patients who had undergone complete resection of a primary HAS between April 2004 and December 2019

Exclusion Criteria:

* Patients with metastatic disease, patients who had undergone palliative surgery, patients who had died within 30 days, and patients who were lost to follow-up

Primary outcomes:
measure: Reurrence-free survival
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT01140464: Reaching Out to Adolescents With Depression
Official title: Adolescent Collaborative Care Treatment for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Adolescents
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Kaiser Permanente
name: University of Washington
First posted: 2010-06-09
Enrollment: 101
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Major Depression is one of the most common mental health disorders in adolescence and is associated with significant impairments in development and functioning. This project will rigorously test the Adolescent Collaborative Care Treatment intervention, a health services intervention designed to improve management for depressive disorders among adolescents, via a randomized controlled trial comparing the intervention to usual care. Key components of the trial include enhanced education for youth and parents, youth involvement in choice of evidence-based treatments, care management by an allied health professional with regular supervision by a mental health specialist and pediatrician, and stepped care to advance treatment when youth are not improving. Additional features have been added to engage adolescents and parents including a moderated message board for youth to share with and learn from one another, formalized involvement of the parent, and availability of the care manager during after school hours. Our findings will provide key information on the effectiveness of a developmentally-sensitive adapted collaborative care intervention for the treatment of adolescent depression.


Eligibility criteria: Inclusion Criteria:

* depression
* age 13-17 years
* enrollment in study Primary Care Clinics

Exclusion Criteria:

* suicidality
* already enrolled Specialty mental health care
* mental health hospitalization in the prior year
* substance abuse
* bipolar disorder
* non-English speaker

Primary outcomes:
measure: Child Depression Rating Scale
timeFrame: 12 months
Secondary outcomes:
measure: Columbia Impairment Scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Cooperative
state: Washington
Study officials:
References:
citation: Wright DR, Haaland WL, Ludman E, McCauley E, Lindenbaum J, Richardson LP. The Costs and Cost-effectiveness of Collaborative Care for Adolescents With Depression in Primary Care Settings: A Randomized Clinical Trial. JAMA Pediatr. 2016 Nov 1;170(11):1048-1054. doi: 10.1001/jamapediatrics.2016.1721.
citation: Richardson LP, Ludman E, McCauley E, Lindenbaum J, Larison C, Zhou C, Clarke G, Brent D, Katon W. Collaborative care for adolescents with depression in primary care: a randomized clinical trial. JAMA. 2014 Aug 27;312(8):809-16. doi: 10.1001/jama.2014.9259.