louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02308865: Early Palliative Care in Metastatic Lung Cancer in Northern France
Official title: Impact of Early Palliative Care on Quality of Life and Survival of Patients With Non-small-cell Metastatic Lung Cancer in Northern France
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer Metastatic
Keywords: Early palliative care
Lung cancer
Quality of life
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Santelys Association
name: Novartis
First posted: 2014-12-04
Enrollment: 71
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: Single-center, prospective, controlled, open-label, randomized, two parallel arms comparing early Palliative care versus Standard care in patients with non-small-cell metastatic lung cancer

Detailed description: 144 patients will be included; 72 per arm.

* "Standard" Control arm: patient supported by the onco-respiratory service.
* Intervention arm: patients benefit from early palliative care in addition to standard onco-pneumologic care.

The main criterion of judgment is the TOI score measured at 12 weeks.

FACTL questionnaires, HADS and PHQ-9 will be filled out before randomization , at 12 weeks and 21 weeks

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with non-small cell lung cancer

  * Proven histologically
  * Metastatic proven imaging (MRI, CT Scanner, PET scan)
  * Stage IV (any T, any N, M1)
* prior to secondary chemotherapy treatment.
* Age\> 18 years
* PS ≤2
* Patient able to understand the nature, purpose and methodology of the study
* signed Informed consent

Exclusion Criteria:

* Age \<18 years
* Patient already supported by palliative care
* Patient with an activating EGFR mutation or EML4-ALK rearrangement or ROS1 gene translocation
* Patient under trusteeship / guardianship

Primary outcomes:
measure: quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: SURVIVAL
timeFrame: from baseline
measure: EVENTS
timeFrame: 14 days before deaths
measure: QUALITY OF LIFE
timeFrame: 12 and 21 weeks
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Licia Touzet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
Clinical trial NCT01627665: Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban
Official title: New Oral Anticoagulant Drugs Dabigatran Etexilate and Rivaroxaban: Influence of Genetic Factors in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Healthy Volunteers
Keywords: dabigatran
rivaroxaban
PKC
PKD
p-glycoprotein
polymorphism
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.

Detailed description: The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.

Eligibility criteria: Inclusion Criteria:

* Healthy participants
* Aged between 18-35 years inclusive
* Male
* Caucasian
* Body mass index (BMI) between 18 and 27 kg per m² inclusive.

Primary outcomes:
measure: AUC of plasma concentrations of the drugs
timeFrame: over 24h after single oral dose
Secondary outcomes:
measure: PKD of the drugs
timeFrame: over 24h after single oral dose
Other outcomes:
Locations:
city: Paris
country: France
facility: CIC Hopital europeen george pompidou
Study officials:
affiliation: CIC HEGP
name: Anne Blanchard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foulon-Pinto G, Jourdi G, Perrin J, Abdoul J, Paris G, Gouin-Thibault I, Curis E, Lecompte T, Siguret V. Study of thrombin generation with St Genesia to evaluate xaban pharmacodynamics: Analytical performances over 18 months. Int J Lab Hematol. 2021 Aug;43(4):821-830. doi: 10.1111/ijlh.13443. Epub 2020 Dec 28.
citation: Marques P, Courand PY, Gouin-Thibault I, Zhygalina V, Bergerot D, Salem JE, Funck-Brentano C, Loriot MA, Azizi M, Blanchard A. P-glycoprotein influences urinary excretion of aldosterone in healthy individuals. J Hypertens. 2019 Nov;37(11):2225-2231. doi: 10.1097/HJH.0000000000002150.
Clinical trial NCT05561465: Pterygomaxillary Disjunction With Interpositional Y-shape Plate in Patients With Temporomandibular Joint Derangement
Official title: Evaluation of Pterygomaxillary Disjunction With Interpositional Y-shape Plate as an Innovative Minimally Invasive Technique in Patients With Temporomandibular Joint Internal Derangement (Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Temporomandibular joint internal derangement (TMJ ID) is the most frequent type of temporomandibular disorder (TMDs)which is managed by different therapeutic modalities. it begins with conservative methods like medical treatment, physiotherapy, thermotherapy, and bites appliance therapy. Surgical intervention is a controversial issue in cases not responding to conservative methods. A novel minimally invasive surgical technique which is extracapsular trans oral (Pterygomaxillary disjunction) has been advocated as a minimally invasive extracapsular technique that preserves TMJ integrity.


Eligibility criteria: Inclusion Criteria:

* Patients without relevant disease
* Patients refractory to conservative treatment \> 6 months.
* Patients are diagnosed, with unilateral/bilateral anterior disc displacement without reduction, clinically and by MRI recently.
* No previous TMJ surgery.
* No previous maxillofacial trauma.

Exclusion Criteria:

* Patients with systemic joint disease (rheumatoid, osteoarthritis, gouts).
* Medically compromised patients contraindicating operation.
* Patients to whom general anesthesia is contraindicated.
* Patient with neuromuscular disorders.
* Patients with any gross pathology of the ear.
* Patient with psychoneurotic disorders.

Primary outcomes:
measure: Change in wound healing
timeFrame: 1st week and 2nd week
measure: Change in TMJ clinical dysfunction
timeFrame: 1st week, 2nd week, 1 month, and 3 months
measure: disc position
timeFrame: at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT03875365: Institutional Outcome Data From Per-oral Plication of the Esophagus
Official title: Institutional Outcome Data From Per-oral Plication of the Esophagus (POPE)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Achalasia
Keywords: POPE
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 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: Patients who have already undergone Per-oral Plication of the Esophagus (POPE) procedure for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus.

Brief summary: Researchers are reviewing and analyzing surgical and clinical outcomes of subjects who underwent POPE for end-stage achalasia, a sigmoid esophagus, or a redundant conduit that has been used to replace the esophagus. This data will help researchers determine the safety and efficacy of a novel minimally invasive treatment compared to invasive surgery.

Detailed description: Researchers will be collecting electronic medical data for subjects who have already undergone Per-oral Plication of the Esophagus (POPE) procedure. Subject characteristics, radiographic documentation, videos, procedural details, and subject reported outcomes would be collected. This data will be used for review and analysis to answer questions aimed in this study. Data collected from this study will be entered into a database that will be maintained for future research.

Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years of age
* Patients who have already undergone Per-oral Plication of the Esophagus (POPE) procedure

Exclusion Criteria:

* Patients \<18 years of age

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 01/01/2017-9/17/2018
measure: Patient Reported Outcomes using the CONDUIT patient questionnaire.
timeFrame: 01/01/2017-9/17/2018
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Shanda Blackmon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06116565: A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis
Official title: An Multi-center, Open-label, Single-arm Phase 2 Study to Evaluate the Long-term Safety and Efficacy of CM310 in Subjects With Moderate-to-severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis.

Detailed description: The study consists of an screening period, treatment period, and safety follow-up period.

Eligibility criteria: Inclusion Criteria:

* Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
* Age ≥ 18 and ≤ 75 years old.
* With Atopic Dermatitis.

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Concurrent disease/status which may potentially affect the efficacy/safety judgement.
* Major surgeries are planned during the study period.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: up to Week 60
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01341665: Subclassification of the Syndrome of Inappropriate ADH Secretion
Official title: Subclassification of the Syndrome of Inappropriate Antidiuresis Via Copeptin - What is the Genesis of ADH-independent SIADH?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyponatremia
Keywords: hyponatremia
SIADH
copeptin
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
First posted: 2011-04-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic hyponatremia (\> 3 days) due to SIADH in university hospital in wuerzburg

healthy control subjects with normonatremia

Brief summary: The aim of this study is to evaluate the different types of osmotic dysregulation in patients with Syndrome of Inappropriate ADH (SIADH) and, hence, to analyze the pathophysiology of SIADH.

These types will be characterized by measurement of AVP and copeptin while performing an osmotic stimulation with infusion of hypertonic saline.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years,
* hyponatremia \< 132 mmol/L
* SIADH

Exclusion Criteria:

* age \< 18 years
* cerebral metastases
* serum sodium \> 132mmol/L

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University of Wuerzburg
state: Bavaria
Study officials:
affiliation: Ethical commitee
name: Bruno Allolio, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04145765: Risk-taking, Self Control and Humor Styles
Official title: The Relationship of Risk Perceptions and Risk-taking With Humor Styles: Mediating Role of Self-control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risk-Taking
Humor as Topic
Self-Control
Lead sponsor: University of Bojnord
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 380
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The numbers of 380 completed questionnaires were collected. The participants were in range 18 to 29 years old and the mean and standard deviation were 20.27 and 1.96, respectively. Given at the University of Bojnord the proportion of females to males is 70 percent to 30 percent that the proportion of females and males in the sample was observed. In this manner, the 78 percent, 17.7 percent and 4.4 percent of participants were female, male and uncertain, respectively.

Brief summary: Therefore, this study tries to examine relationships among risk perception, risk-taking and humor styles through the mediating role of self-control. The present study used the correlation method. The statistical population consisted of all undergraduate students from University of Bojnord. The number of 400 students from the Faculty of Humanities and Basic Sciences was selected by using cluster sampling. The questionnaires were distributed in the classes among who inclined to participate in this study and they completed the questionnaires as anonymous.


Eligibility criteria: Inclusion Criteria:

* be a student of the college

Exclusion Criteria:

* Unwillingness to study And not being a student at university

Primary outcomes:
measure: Self-Control
timeFrame: 2 days
measure: Humor styles
timeFrame: 2 days
measure: risk taking
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bojnourd
country: Iran, Islamic Republic of
facility: university of Bojnord
state: North Khorasan
Study officials:
affiliation: University of Bojnord
name: Malahat Amani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04594265: Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure
Official title: Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Heart Failure
Ketosis
Keywords: Hemodynamics
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients are studied in a randomized single-blind cross-over design.
Primary purpose: TREATMENT

Brief summary: We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.


Eligibility criteria: Inclusion criteria: Chronic HF: NYHA class II-III, left ventricular ejection fraction (LVEF) \<40%

Exclusion Criteria: Diabetes or HbA1c \>48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent

Primary outcomes:
measure: Cardiac Output (L/min)
timeFrame: 3 hours - Area under the curve
Secondary outcomes:
measure: Left Ventricular Ejection Fraction
timeFrame: 3 hours - Area under the curve
measure: Blood Ketones
timeFrame: 3 hours
measure: Blood pH
timeFrame: 3 hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT05057065: A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB
Official title: Disease Progression and Intervention of Chronic HepatitisB Based on Diabetes and Hyperlipidemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B, Chronic
Keywords: HBV
metabolic diseases
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 10000
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: Chronic hepatitis B patients

Brief summary: HBV(hepatitis B virus) with metabolic comorbidities may accelerate liver disease progression and increase the risk of HCC(Hepatocellular Carcinoma)development. It is reported combination of metabolic diseases and CHB is associated with substantially increased rates of liver cirrhosis and secondary liver-related events compared to CHB alone. Consequently, hepatitis B patients with metabolic comorbidities warrant particular attention in disease surveillance and evaluation of treatment indications.

Detailed description: Primary objective:

To evaluate the impact of metabolic disease on the progression of chronic hepatitis B

* To observe HBsAg/HBeAg/HBV DNA changes /HBsAg seroconversion
* To determine high rates of Liver Cirrhosis and Hepatocellular Carcinoma

Group 1 : CHB with diabetes Group 2 : CHB with hyperlipemia Group 3 : CHB without metabolic diseases

Study Duration (in months) 24 months

Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis B (positive HBsAg for at least 6 months prior to NA therapy start)
* Patients on-treatment with NAs

Exclusion Criteria:

* Treatment with immunosuppressors (including systemic corticosteroids) or anti-neoplastic treatment (including radiation therapy) \<=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
* History of depression or uncontrolled psychiatric disorders
* Subjects protected by law or not in a position to give consent

Primary outcomes:
measure: Efficacy of NAs therapy
timeFrame: 2 year
Secondary outcomes:
measure: Incidence of liver fibrosis and cirrhosis
timeFrame: 2 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The 2nd affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: HONG REN, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00172965: Diagnosis of Oral Precancers and Cancers Using Optic Coherence Tomography
Official title: Diagnosis of Oral Precancers and Cancers Using Optic Coherence Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Cancers
Keywords: Optic coherence tomography
oral cancer
oral precancers
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Diagnosis of oral precancers and cancers using optic coherence tomography

Detailed description: Diagnosis of oral precancers and cancers using optic coherence tomography

Eligibility criteria: Inclusion Criteria:

* oral cancer, oral precancers

Exclusion Criteria:

* other diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chun-Pin Chiang, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00696865: AZD2624 Multiple Ascending Dose Study in Japan
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2624 When Given in Multiple Ascending Oral Doses in Young Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Safety
Keywords: Safety
Tolerability
Phase I
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This multiple ascending dose study will evaluate safety and tolerability after repeated ascending doses of AZD2624


Eligibility criteria: Inclusion Criteria:

* Healthy young male Japanese volunteers

Exclusion Criteria:

* Significant illness, as judged by the investigator, within 2 weeks of screening visit or Day 1
* Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit or Day 1
* Blood loss in excess of 200 mL within 30 days of screening visit or Day 1, in excess of 400 mL within 90 days of screening visit or Day 1, or in excess of 1200 mL within 1 year of screening visit or Day 1
* Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator at screening or pre first dose

Primary outcomes:
measure: To assess the safety and tolerability of multiple ascending oral doses of AZD2624 in young healthy male Japanese subjects compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEGs
timeFrame: All assessments are made at each visit, at least daily, during the study.
Secondary outcomes:
measure: To evaluate and characterize the pharmacokinetics of AZD2624 and its metabolites when given orally in multiple ascending doses of AZD2624 to young healthy male Japanese subjects by assessment of drug concentration in plasma
timeFrame: Blood samples will be taken before and after study drug administration.
measure: Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD2624
timeFrame: A single blood sample will be obtained
Other outcomes:
Locations:
city: Kanagawa
country: Japan
facility: Research Site
Study officials:
affiliation: Kitasato University East Hospital, Kanagawa, Japan
name: Yuji Kumagai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: