louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03528525: Registry Study on Respiratory Monogenic Diseases in Chinese Children
Official title: Beijing Children's Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Monogenic Diseases
Keywords: Diseases
Children
Respiratory
Monogenic diseases
China
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
Collaborators: name: Capital Institute of Pediatrics, China
name: Shengjing Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: The Children's Hospital of Zhejiang University School of Medicine
name: Children's Hospital of Chongqing Medical University
name: The first clinical college of Guangzhou medical university
name: Guangzhou Women and Children's Medical Center
name: Yuying Children's Hospital of Wenzhou Medical University
First posted: 2018-05-18
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who was confirmed diagnosis as respiratory monogenic diseases at the certain hospitals (sponsor and collaborators)

Brief summary: This study is a multicenter, prospective cohort study of patients diagnosed with respiratory monogenic diseases, the clinical information of recruited patients, including clinical manifestations, lung function, chest imaging, quality of life and other indicators, will be followed for 5 years.

Detailed description: All new cases of respiratory monogenic diseases was confirmed or diagnosed at each center from the beginning of the study are made the investigation of the clinical manifestations and specific tests by the standard diagnostic process.Then all the patients' following clinical data will be followed for 5 years: clinical manifestations, lung function, chest imaging (once per year), gene test, quality of life and other indicators.

Eligibility criteria: Inclusion Criteria:

1. Age: 0-18 years, male and female.
2. Any organ system symptoms consistent with the diagnostic points of respiratory monogenic diseases.
3. Agree to retain specimens related to disease research and agree to store the specimens in the sample bank.
4. willing and able to cooperate with long-term follow-up.
5. The guardian of the child has a full understanding of the purpose of the study, a basic understanding of the clinical research program, and voluntarily allows the child to participate in the study and sign an informed consent form.

Exclusion Criteria:

1. It is unable to provide complete medical records or the current condition can not accept the diagnosis process
2. She or he cannot agree to participate in the study.

Primary outcomes:
measure: Change from baseline in lung function on the spirometry
timeFrame: 1 year later
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04082325: Study Investigating the Safety and Tolerability of Lu AF88434 in Healthy Young Men
Official title: Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-oral-dose Study Investigating the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Properties of Lu AF88434 and Open-label Crossover Study to Investigate the Intra-individual Variability, Metabolic Profile, and Effect of Food on Lu AF88434 in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2019-09-09
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of Lu AF88434 on the body and what the body does to Lu AF88434 and the effect of food after swallowing single oral doses


Eligibility criteria: Inclusion Criteria:

-Healthy young non-smoking men with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit and Baseline Visit.

Exclusion Criteria:

* The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
* For Part B: The subject has received radiolabelled material \<12 months prior to the Screening Visit.

Other inclusion and exclusion criteria may apply

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events
timeFrame: From screening to Day 11
measure: Cmax Lu AF88434
timeFrame: From 0 to 96 hours
measure: AUC(0-inf) Lu AF88434
timeFrame: From 0 to 96 hours
measure: CL/F Lu AF88434
timeFrame: From day 1 to day 5
measure: Cumulative recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)
timeFrame: From 0 to Day 14
measure: Total recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)
timeFrame: From 0 to Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: QPS
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT05303025: Qualitative Research Among Physicians and Junior Doctors Into the Preconditions for Implementing a CDSS Based on AI in the ICU
Official title: Qualitative Research Among Physicians and Junior Doctors Into the Preconditions for Implementing a Clinical Decision Support System (CDSS) Based on Artificial Intelligence (AI) in the ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Artificial Intelligence
Qualitative Research
Decision Support Systems, Clinical
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2022-03-31
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical specialists or specialists in training working in intensive care at the time of the study.

Brief summary: The goal of this study is to explore the different attitudes and preconditions of potential end-users (doctors \& physicians in training) required to achieve successful clinical implementation of models based on artificial intelligence (i.e. both machine learning and knowledge-driven techniques) as clinical decision support software.


Eligibility criteria: Inclusion Criteria:

* Medical specialist or specialist in training working in intensive care at the time of the study.

Exclusion Criteria:

* Age \< 18 yo

Primary outcomes:
measure: Baseline attitudes towards artificial intelligence and big data in medicine
timeFrame: baseline
measure: Identify subdomains of the antimicrobial stewardship cycle with potential for AI/Big data application
timeFrame: through study completion, an average of 1 year
measure: Identify perceived potential benefits and harms when applying AI in the antimicrobial stewardship cycle.
timeFrame: through study completion, an average of 1 year
measure: Identify prerequisites that need to be fulfilled when AI/Big data based clinical decision support systems are used bedside from the viewpoint of the participants.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Subgroup analysis: age
timeFrame: through study completion, an average of 1 year
measure: Subgroup analysis: gender
timeFrame: through study completion, an average of 1 year
measure: Subgroup analysis: working environment (type of hospital, type of ICU)
timeFrame: through study completion, an average of 1 year
measure: Subgroup analysis: working experience (basic training and clinical experience).
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Aalst
city: Antwerpen
country: Belgium
facility: ZNA Ziekenhuizen
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Ghent
name: Jan De Waele, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05338125: Electrophysiology of the Human Pituitary Gland
Official title: Identification of the Posterior Lobe of the Human Pituitary Gland During Surgery Using Its Electrophysiological, Neural Signature
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pituitary Adenoma
Pituitary Tumor
Diabetes Insipidus Cranial Type
Endocrine; Deficiency
Keywords: Electrophysiology
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot proof-of-concept study
Primary purpose: PREVENTION

Brief summary: Measurment of electrophysiological properties of the human pituitary gland during removal of a pituitary adenoma. Assessment if these properties are sufficient for intra-operative identification of different tissues.

Detailed description: In this study, patients undergoing a surgical resection of a pituitary adenoma as part of standard care will undergo an extra measurement of the electrophysiological properties of the pituitary gland. A single-unit microlectrode will be introduced and placed in the adenoma tissue, anterior piuitary lobe and posterior pituitary lobe. Apart from this measurement, no other interventions are performed and standard care will continue. Six months after measurements the patients chart will be assessed for the occurrence of remission and endocrine deficiencies.

An assessment will be made if these properties are distinctive enough to allow intra-operative identification of the different tissues and thereby increase chances of maximal tumour removal and decrease chance of endocrine deficiencies.

Eligibility criteria: Inclusion Criteria:

* Male and female patients undergoing transsphenoidal surgery for pituitary adenoma.
* Identification of the posterior lobe on preoperative MRI. This is most common in patients with micro-adenomas or small macroadenomas.
* Age \>18 years

Exclusion Criteria:

* Emergency surgery
* Cognitive impairments
* Pregnancy
* Pre-existing diabetes insipidus

Primary outcomes:
measure: Electrophysiological properties
timeFrame: Day 0
Secondary outcomes:
measure: Endocrine remission
timeFrame: 6 months postoperative
measure: Endocrine deficiencies
timeFrame: 6 months postoperative
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
References:
Clinical trial NCT04528225: A Prospective Study of Hypothyroidism After Radiotherapy for Breast Cancer
Official title: Hypothyroidism After Postoperative Radiation Therapy in Patients With Breast Cancer：a Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Hypothyroidism
Radiation Toxicity
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2020-08-27
Enrollment: 729
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients treated with radiotherapy after surgery are enrolled.

Brief summary: This study is to prospectively investigate the incidence of hypothyroidism after postoperative radiotherapy and identify risk factors for development of hypothyroidism. Patients with breast cancer treated with surgery followed by radiotherapy is enrolled. Thyroid function was assessed at baseline and different times after radiotherapy. The radiation technique, thyroid dose parameters and hypothyroidism are prospective evaluated, and the dose-effect relationship is analyzed.

Detailed description: Breast cancer patients treated with radiotherapy after surgery are prospectively enrolled. Thyroid function is evaluated mainly by the measurement of thyroid-stimulating hormone (TSH), free triiodo-thyronine (FT3) and free thyroxine (FT4). Thyroid function is regularly assessed before and after radiotherapy. The radiation technique and thyroid dose parameters are assessed. Development of subclinical or biochemical hypothyroidism is noted. The incidence and risk factors of hypothyroidism is analyzed. The dose-volume constraints that correlate with functional impairment of the thyroid in breast cancer patients treated with radiotherapy is discussed.

Eligibility criteria: Inclusion Criteria:

Breast cancer patients at first diagnosis, patients who are treated with radiotherapy after breast conserving surgery or modified radical mastectomy, no medical history of hyperthyroidism, hypothyroidism or thyroiditis, have never taken thyroxine, no thyroid surgery.

Exclusion Criteria:

Absence or ectopic thyroid gland, previous radiotherapy of the neck, diseases of thalamus or pituitary, previous radiotherapy of thalamus or pituitary

Primary outcomes:
measure: Number of participants with treatment-related hypothyroidism as assessed by CTCAE v4.0
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Shu-lian Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05479825: Tubeless Intersegmentectomy Plane Identification With Fluorography
Official title: Tubeless Intersegmentectomy Plane Identification With Inflation- Deflation Line Combined With Fluorography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Operation Time
Postoperative Complications
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Background: We aimed to evaluate the combination of inflation- deflation method and fluorography with the ICG injection in the tubeless minimally invasive segmentectomy (no intubation, VATS or Robotic).

Methods: A one- armed, prospective randomized controlled study was designed. The intersegmental plane was not so clear during the tubeless minimally invasive segmentectomy, and the presentation of the plane sometimes cost more time. This study will evaluate consecutive patients with the combination of inflation- deflation method and fluorography with the ICG injection.


Eligibility criteria: Inclusion Criteria:

1. cardio- pulmonary function can tolerate the minimally invasive surgery (including VATS and robotic surgery);
2. benign pulmonary lesion considering for segmentectomy;
3. ≤2cm pulmonary adenocarcinoma with ground- glass components, considering for segmentectomy.

Exclusion Criteria:

1. cardio- pulmonary function can not tolerate the minimally invasive surgery (including VATS and robotic surgery);
2. segmentectomy is not considered as the surgery plan.

Primary outcomes:
measure: time of description and management of the intersegmental plane
timeFrame: during surgery
measure: perioperative complication rate
timeFrame: within 7 days after surgery
measure: incisal margin of the tumor
timeFrame: during surgery
Secondary outcomes:
measure: disease- free survival
timeFrame: within 5 years after surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Yunpeng Zhao
state: Other (Non U.s.)
Study officials:
affiliation: The Second Hospital of Shandong University
name: Xiaogang Zhao, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00568425: QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT
Official title: Quality of Life and Functional Outcomes After Combined Modality Therapy for Anal Cancer: A Comparison of Conventional Versus Intensity-Modulated Radiation Therapy (ANAL0002)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anal Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically confirmed diagnosis of squamous cell carcinoma of the anus

Brief summary: The purpose of this study is show that intensity-modulated radiotherapy (IMRT), as compared with conventional radiotherapy, improves the precision of tumor targeting and reduces the acute and late effects of radiation toxicity when used to treat anal cancer. Results from this work will provide a basis for incorporating the use of IMRT to treat anal cancer in future treatment protocols.

Detailed description: The objectives of this study are three-fold. First, we would like to learn and compare the doses of radiation received by the tumor and the normal tissues in anal cancer patients treated with IMRT, and in those treated with conventional radiotherapy. Second, we wish to compare the acute effects of radiation treatment in both groups of patients. Our third objective is to evaluate the late effects of radiation treatment in both groups of patients. The first two objectives will be studied using a retrospective analysis of patients with anal cancer treated at Stanford University Medical Center. The third objective will require these patients to complete and return three quality of life questionnaires.

Eligibility criteria: Inclusion Criteria:Histologically confirmed diagnosis of squamous cell carcinoma of the anus. Must be able to provide informed consent. Exclusion Criteria:History of new malignancy since the time of treatment for anal cancer. Non-English speaking.

Primary outcomes:
measure: Evaluate the late effects of radiation treatment
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Mark Lane Welton
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01403025: Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes
Official title: A Multi-centre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Victoza® in Subjects With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-07-27
Enrollment: 4121
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who are considered to need treatment with liraglutide (Victoza®)

Brief summary: This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions).


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who require treatment with liraglutide

Exclusion Criteria:

* Subjects who are or have previously been on liraglutide
* Subjects who have previously been enrolled in the study
* Subjects with a hypersensitivity to liraglutide or to any of the excipients
* Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods
* Subjects with cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the trial
* Known or suspected abuse of alcohol or narcotics

Primary outcomes:
measure: The incidence of SADRs (Serious Adverse Drug Reactions)
timeFrame: After 36 months
Secondary outcomes:
measure: The incidence rate and type of SAEs (Serious Adverse Events)
timeFrame: At month 1, 3, 6, 12, 24 and 36
measure: The incidence rate and type of ADRs (Adverse Drug Reactions)
timeFrame: At month 1, 3, 6, 12, 24 and 36
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02943122: Ambulatory Blood Pressure Monitoring in Post-Partum Pre-Eclamptic Patients
Official title: Prognostic Value of Ambulatory Blood Pressure Monitoring Pattern in Post-Partum Pre-Eclamptic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decrease Maternal Morbidity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all women suffered from preeclampsia in last pregnancy will be examined 3 months after delivery /or termination

Brief summary: Preeclamptic pregnancy is associated with alterations in the left ventricular structure and function and elevation of cardiovascular biomarkers. The alterations are still persistent several months after delivery and are more clearly observed in early-onset and severe Pre-eclampsia


Eligibility criteria: Inclusion Criteria:

* All previously healthy women who were diagnosed as preeclampsia.( defined as gestational hypertension ( systolic BP of at least 140 mm Hg and/or a diastolic BP of at least 90 mm Hg on at least two occasions at least 6 hours apart after the 20th week of gestation in women known to be normotensive before pregnancy and before 20 weeks' gestation ) plus proteinuria (300 mg or more per 24-hour period)

Exclusion Criteria:

* Current pregnancy
* Chronic hypertension or any condition requiring the use of antihypertensive medication
* Chronic kidney disease
* Any disease requiring the use of anti-inflammatory medication, diabetes or any other endocrine disease such as hyperthyroidism

Primary outcomes:
measure: number of women with persistent hypertension
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References: