louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01793675: Haplo-identical/Mismatched Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome
Official title: Haplo-identical/Mismatched Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced MDS Without Identical Sibling Donor
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 116
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with MDS:1)intermediate-2 or high risk 2)low or intermediate-1 risk, drug resistance or disease progression

Brief summary: Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the only curative treatment for myelodysplastic syndrome (MDS), especially for advanced MDS (blast \>5%). However, many patients cannot find an HLA-matched donor. haploidentical donor is an alternative stem cell source.

the study hypothesis: Haploidentical/mismatched hematopoietic stem cell transplantation can improve the survival of patients with myelodysplastic syndrome


Eligibility criteria: Inclusion Criteria:

* Patients with MDS (1)intermediate-2 or high risk (2)low or intermediate-1 risk with drug resistance or disease progression
* without identical sibling donor

Exclusion Criteria:

* Contraindication to HSCT
* Pregnancy
* Mental illness

Primary outcomes:
measure: survival rate
timeFrame: participants will be followed for an expected average of one year
Secondary outcomes:
measure: incidence of non-relapse mortality
timeFrame: one year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Nanfang Medical University
state: Guangdong
city: Tangshan
country: China
facility: Hebei Tangshan Steel and Iron Company Hospital
state: Hebei
city: Nanjing
country: China
facility: Nanjing Gulou Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou University The 1st Affiliated Hospital
state: Jiangsu
city: Chongqing
country: China
facility: Chongqing Medical University The 1st Affiliated Hospital
state: Sichuan
city: Chongqing
country: China
facility: The 3rd Army Medical University The 2nd Affiliated Hospital
state: Sichuan
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Aerospace center hospital
Study officials:
affiliation: Peking University People's Hospital
name: xiaojun huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02119975: A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals
Official title: A Working Memory Training to Decrease Rumination in Depressed and Anxious Individuals: A Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Anxiety Disorder
Keywords: Rumination
Working memory
Depression
Anxiety
Working memory training
Overgeneral memories
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dysfunctioning executive functioning, including working memory (WM), is related to rumination. Findings show that working memory capacity (WMC) can be increased by training. The current study explored by means of a double-blind randomized controlled trial whether an adaptive WM training could reduce rumination, anxiety and depression in a sample of 98 depressed and anxious individuals.


Eligibility criteria: Inclusion Criteria:

* Major depression diagnosis
* Anxiety diagnosis

Exclusion Criteria:

* Current psychosis
* Substance abuse

Primary outcomes:
measure: Change in Ruminative Response Scale (RRS) score from pre to post training and after two months (follow up 2)
timeFrame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Secondary outcomes:
measure: Change in Beck Depression Inventory Second Edition (BDI-II) score from pre to post training and after two months (follow up 2)
timeFrame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
measure: Change in State-Trait Anxiety Inventory (STAI) score from pre to post training and after two months (follow up 2)
timeFrame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Other outcomes:
measure: The change in Internal Shift Task (IST) score from pre to post training and to follow up (two months after post)
timeFrame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
measure: The change in Digit Span score from pre to post training and to follow up (two months after post)
timeFrame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
measure: The change in Reading Span partial-credit unit score from pre to post training and to follow up (two months after post)
timeFrame: Pre training (baseline), post training (4 weeks after baseline, training starts 1 day after baseline) and follow-up (2 months after post-test)
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Rotterdam
state: Zuid Holland
Study officials:
References:
Clinical trial NCT03117075: The Efficacy of Pain Management With Self-reporting Pain Monitoring System in Cancer Patient
Official title: The Efficacy of Pain Management With Self-reporting Pain Monitoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: cancer pain, wearable device
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the pain scales between clinician evaluated and reported with wearable device by patients.

Detailed description: To compare the pain scales between clinician evaluated and reported with wearable device by patients with cancer of advanced stage.

Eligibility criteria: Inclusion Criteria:

* over 20 year old
* cancer pain with visual analog scale or numeric rating scale score \>/- 4
* opioids candidates
* with informed consent form

Exclusion Criteria:

* life expectancy within 3 months

Primary outcomes:
measure: Actual difference of pain scales
timeFrame: 1 week after using wearable pain scale device - baseline and 1 week.
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Daejeon St. Mary's Hospital, the Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, the Catholic University of Korea
Study officials:
affiliation: Uijeongbu St. Mary's Hospital, The Catholic University of Korea
name: YOONHO KO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03416075: Mechanical Ventilation in Interstitial Lung Disease
Official title: Risk Factors for Mortality in Patients With Interstitial Lung Disease Receiving Mechanical Ventilation: A Retrospective, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Mechanical Ventilation
Risk Factors
Morality
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were diagnosed as interstitial lung disease and received mechanical ventilation.

Brief summary: To identify risk factors for mortality in patients with interstitial lung disease receiving mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

1. They were clearly diagnosed as interstitial lung disease in hospital;
2. They had progressive worsening of dyspnea and their oxygenation indexes were less than 300 in ICU;
3. They received at least 48 hours of mechanical ventilation after being admitted into ICU.

Exclusion Criteria:

* We excluded patients who were admitted into ICU because of postoperative monitoring.

Primary outcomes:
measure: ICU Mortality
timeFrame: 7 years
Secondary outcomes:
measure: Hospital mortality
timeFrame: 7 years
measure: Noninvasive mechanical ventilation failure
timeFrame: 7 years
measure: Invasive mechanical ventilation failure
timeFrame: 7 years
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Zujin Luo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04543175: Taste Disorders and Their Relation to BMI, FFQ, and EORTC QLQ-BR23 in Breast Cancer Patients During Chemotherapy.
Official title: Taste Disorders and Their Relation to Body Mass Index, Food Frequency Questionnaire and Quality of Life in Breast Cancer Patients During Chemotherapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Taste Disorders
Dysgeusia
Ageusia
Quality of Life
Lead sponsor: Hospital General de Mexico
Sponsor class: OTHER_GOV
First posted: 2020-09-10
Enrollment: 106
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of Oncology ward in Hospital General de Mexico between 20 and 60 years old with newly diagnosed breast cancer.

and chemotherapy with Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC) or Docetaxel.

Brief summary: Taste disorders in cancer patients during chemotherapy could be consider as multifactorial disease, it is related with changes of food consumption. Approximately 36-69% of the patients under chemotherapy suffer oral toxicity or dysgeusia

A prospective case- only observational study was conducted in patients of the Hospital General de México for two years. A self-reported taste survey was used, and patients scored their results in a Likert scale.


Eligibility criteria: Inclusion Criteria:

- Chemotherapy with Doxorubicin + Cyclophosphamide (DC) or Paclitaxel + Carboplatin (PC) or Docetaxel.

Exclusión Criteria:

* No smokers Infections in oral cavity Acute respiratory diseases Gastro- oesophageal reflux disease Other types of cancer.

Primary outcomes:
measure: Prevalence of taste disorders and perception of the four basic flavors
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital General de México
Study officials:
References:
Clinical trial NCT06017375: Patient Knowledge, Beliefs and Barriers to Hepatitis D Care
Official title: Patient Knowledge, Beliefs and Barriers to Hepatitis D Care; Single Site Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatitis, Delta
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with past or current hepatitis D virus infection

Brief summary: A project to understand the determinants of health behaviour among those with chronic hepatitis D virus (HDV) infection, under the care of the viral hepatitis service at Kings College Hospital (KCH). This is to improve and implement pathways and patient information distribution to improve access to care in an ethnically diverse population living with HDV in the UK.

Kings college hospital NHS Foundation Trust is uniquely placed and serves a large diverse population from areas such as pan pacific Asia, Eastern Europe and regions in Africa, where English is not their first language. This diversity is also seen in other London Hospitals but less so in other parts of the UK.

Detailed description: To understand the knowledge patients have around their diagnosis of hepatitis D which is considered a rare disease but the most aggressive form of viral hepatitis. In order to improve the management of hepatitis D, this research aims to identify the current knowledge patients have about their diagnosis, the information provided to them in their preferred language, how they feel about their diagnosis and the stigma attached. This research has been conducted in patients with other forms of viral hepatitis but not in patients living with hepatitis D. There is a lack of research in this area. With this research we aim to improve treatment pathways, access to care and to information.

Eligibility criteria: Inclusion Criteria:

* Participants 18 years or older.
* HDV infection as diagnosed by high levels of anti-HDV immunoglobulin G (IgG) and immunoglobulin M (IgM), and confirmed by detection of HDV RNA in serum.
* Treated HDV infection
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Clinically significant medical or psychiatric illness in the past, present, or being evaluated, that may interfere with participant treatment, safety and assessment.

Primary outcomes:
measure: The overall patient understanding of Hepatitis D Virus diagnosis
timeFrame: 6 months
measure: Describe overall patient knowledge around HDV
timeFrame: 6 months
Secondary outcomes:
measure: Describe stigma attached towards HDV
timeFrame: 6 months
measure: Understand satisfaction with communication regarding HDV care at KCH
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01915875: Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis
Official title: Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis-pain-sophrology
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fondation de France
First posted: 2013-08-05
Enrollment: 13
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the impact of the global approach to the pain in cystic fibrosis patients with chronic or intermittent pain. The patients will receive in addition to an usual pharmacological and psychological management, sophrology sessions at home. The results of this study will provide a new strategy of management of the patient's pain.

Detailed description: The majority of cystic fibrosis patients have chronic or intermittent pains. These pains have important consequences on the quality of life. Currently, the treatment is essentially pharmacological (essentially paracetamol) but it is not enough in presence of of visual analogue scale (VAS) \>4. In the study, the patients will receive in addition to an usual pharmacological and psychological management, sophrology sessions at home. The sophrology is a dynamic method of physical and psychical relaxation. This aims are to decrease the pain, to decrease the anxiety and to improve the everyday life. This study will provide a new global strategy of the management of the patients' pain.

Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis patients defined by a test sweat and / or 2 pathogenic mutations
* Patients over 10 years
* Patients with pain symptoms (VAS\> 4) recurrent (\> 4 episodes / month) or permanent since more than 6 months
* Agreement of patients, and parents (for children) for sophrology sessions conducted at home.
* Patient affiliated to social security

Exclusion Criteria:

* Transplant patients or placed on a waiting list transplantation
* Patients had a patient-support by techniques hypnosis or relaxation therapy, during or within 3 months.
* Patients enrolled in another research interventional protocol.
* Women without contraception or pregnant.

Primary outcomes:
measure: Change of maximum VAS
timeFrame: 6 months
Secondary outcomes:
measure: number of paroxystic episodes
timeFrame: 6 months
measure: intensity of maximum VAS of the painful episodes
timeFrame: 6 months
measure: Improvement of the quality of life
timeFrame: 6 months
measure: BMI
timeFrame: 6 months
measure: VEMS
timeFrame: 6 months
measure: CVF
timeFrame: 6 months
measure: SaO2
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: hôpital Necker Enfants malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Isabelle Sermet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02584075: Evaluate the Effect of Exenatide Treatment on Coronary Artery Endothelial Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Endothelial Function
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes mellitus (T2DM) is an important risk factor of cardio-cerebral vascular disease such as coronary heart disease. GLP-1 is a kind of incretin secreted by the L-cell located in Ileum. It acts as an incretin hormone by protentiating glucose-stimulated insulin release. Recent studies reported that GLP-1 RA can protect the vascular endothelial and prevent vascular from atherosclerosis. Investigators design this study to investigate exenatide's effect on the improvement of the coronary endothelial function by evaluating endothelium dependent diastolic function and testing the vascular endothelial active substance and related inflammatory factors.


Eligibility criteria: Inclusion Criteria:

* Females or males, and aged 20 to 65 years
* Newly diagnose type 2 diabetes mellitus with BMI\>25kg/m2.
* HbA1C\>8%.

Exclusion Criteria:

* Type 1 diabetes mellitus, diabetic ketoacidosis, diabetic hyperosmolar coma.
* Hepatic insufficiency (ALT or AST\> 1.5\*ULN).
* Renal insufficiency \[Creatinine clearance rate (Ccr)\]\<60ml/min estimated from MDRD equation).
* Thyroid disease
* Use of any anti-diabetic, anti-hypertension or anti-dyslipidemia drugs.
* Pregnant or lactating woman.
* Severe anemia.
* Acute myocardial infarction or stoke.
* Other conditions at investigator's discretion.

Primary outcomes:
measure: Coronary endothelial function
timeFrame: the change of coronary endothelial function(baseline, 12 weeks)
Secondary outcomes:
measure: the changes of fasting plasma glucose (FPG)
timeFrame: the changes of fasting plasma glucose (FPG)(baseline, 12 weeks)
measure: the changes of HbA1C
timeFrame: the changes of HbA1C(baseline, 12 weeks)
measure: the changes of fasting serum insulin (FINS)
timeFrame: the changes of fasting serum insulin (FINS) (baseline, 12 weeks)
measure: the changes of IL-1B
timeFrame: the changes of IL-1B (baseline, 12 weeks)
measure: the changes of IL-6
timeFrame: the changes of IL-6 (baseline, 12 weeks)
measure: the changes of TNF-α
timeFrame: the changes of TNF-α(baseline, 12 weeks)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00254475: A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential Hypertension and Hypercholesterolemia
Official title: A Study to Evaluate the Efficacy of the Valsartan/Simvastatin Combinations 160/20mg up Titrated to 320/20mg Versus 160/40mg up Titrated to 320/40mg in Patients With Both Essential Hypertension and Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Hypercholesterolemia
Keywords: Valsartan
simvastatin
hypertension
hypercholesterolemia
angiotensin II receptor blocker
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-11-16
Enrollment: 871
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide data on the dose response of simvastatin in lowering LDL-C when it is co-administered with valsartan in patients with both essential hypertension and hypercholesterolemia. The primary objective of the study will be to show that the combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the combination of valsartan 160mg/simvastatin 20mg in percentage change from baseline in LDL-C.


Eligibility criteria: Inclusion Criteria:

* Elevated LDL-Cholesterol
* Essential hypertension

Exclusion Criteria:

* Severe Hypertension
* Prior or known muscular or neuromuscular disease of any type
* A history of cardiovascular disease
* Hypertension or hypercholesterolemia due to secondary causes
* Uncontrolled diabetes or insulin treatment
* Evidence of hepatic or renal disease

Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Low density lipoproteins after 6 weeks
Secondary outcomes:
measure: Lipid profile at 6, 12 wks
measure: BP < 140/90 mmHg in non diabetics, or < 130/80 mmHg in diabetics, and LDL-C < 2.6, 3.4 or 4.1 mmol/l based on risk group at 6, 12 wks
measure: SBP < 140 mmHg in non diabetics, < 130 mmHg in diabetics, or 20 mmHg decrease in SBP from baseline and DBP < 90 mmHg in non diabetics, DBP < 80 mmHg in diabetics, or 10 mmHg decrease in DBP from baseline at 6, 12 wks
measure: Systolic and diastolic bp at 6, 12 wks
measure: Serious/adverse events, labs, physical exams, vitals up to 12 wks
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novatis Pharmaceuticals
name: Novartis Pharmaceutical
role: STUDY_DIRECTOR
References:
citation: Rump LC, Baranova E, Okopien B, Weisskopf M, Kandra A, Ferber P. Coadministration of valsartan 160 and 320 mg and simvastatin 20 and 40 mg in patients with hypertension and hypercholesterolemia: a multicenter, 12-week, double-blind, double-dummy, parallel-group superiority study. Clin Ther. 2008 Oct;30(10):1782-93. doi: 10.1016/j.clinthera.2008.10.004.