louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02653339: Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rhinitis, Allergic, Perennial
Keywords: traditional Chinese medicine
Loratadine
questionnaire survey
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a controlled clinical trials about traditional Chinese medicine named Qufeng Shengshi Fang，which consisted of cicada slough，bombyx batryticatus，radix angelicae，radix sileris，honeysuckle flower，forsythia，lithospermum and radix glycyrrhizae，and Loratadine on treatment of Allergic Rhinitis.There are 180 Patients with allergic rhinitis recruited from Department of Allergy and Traditional Chinese.To carry on statistical analysis of the result of the self and between-group cross-reference by two questionnaires filled before and after treatment.


Eligibility criteria: Inclusion Criteria:

* meet allergic rhinitis (include allergic rhinitis with asthma) diagnostic criteria at Peking Union Medical College Hospital Department of Allergy;
* have allergic rhinitis in episodes.
* without antihistamine,local anaesthetic or traditional Chinese medicine in last months.
* signed the informed consent form.

Exclusion Criteria:

* have severe deviation of nasal septum and nasal polyps.
* have nasal surgery or a history of cancer(tumor).
* have other serious illness or evidence of mental disorders.
* female in pregnancy and lactation

Primary outcomes:
measure: Improvement clinical symptoms of Allergen Rhinitis
timeFrame: 0，4 and 8 weeks
Secondary outcomes:
measure: Liver Function Examination
timeFrame: 0，4 and 8 weeks
measure: Renal Function Examination
timeFrame: 0，4 and 8 weeks
measure: Secretory immunoglobulin E Examination
timeFrame: 0 and 8 weeks
measure: Blood Routine Examination
timeFrame: 0，4 and 8 weeks
measure: Urine Routine Examination
timeFrame: 0，4 and 8 weeks
measure: Fractional Exhaled Nitric Oxide Examination
timeFrame: 0 and 8 weeks
measure: Test of Cytokine
timeFrame: 8 weeks
measure: Test of Metabonomics
timeFrame: 8 weeks
measure: Test of Proteomics
timeFrame: 8 weeks
measure: Change of Exosomes
timeFrame: 8 weeks
measure: IncRNA Sequencing
timeFrame: 8 weeks
measure: Pulmonary function Examination
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital traditional Chinese medicine department
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital traditional Chinese medicine department
name: Xiaochun Liang, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04048239: Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation
Official title: Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Hearing Loss
Implant
Keywords: cochlear implant
robotic
mini-invasive
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cochlear Implantation is a system developed to restore hearing in people with profound sensorineural hearing loss, whose classical hearing aids are ineffective. Surgery is necessary to insert the internal part into the cochlea and requires milling the mastoid to access the round window. This approach is technically difficult, and is performed under a microscope by an experienced surgeon. The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics.

Detailed description: The ROSA robot coupled to the O-Arm scanner will guide the milling to the round window, whose path has been previously modeled, with the identification of the facial nerve. Milling will be done in 2 stages with a CT (computerised tomography scan) and electromyographic verification of the facial nerve. The insertion of the implant will be performed manually under endoscopic control. The preoperative and postoperative course of the patient will be identical.

Eligibility criteria: Inclusion Criteria:

* patients eligible for cochlear implantation in CHU Amiens
* patient more than 18 years old.

Exclusion Criteria:

* malformation or significant antecedent of mastoidectomy

Primary outcomes:
measure: cochlear implantation with the ROSA robot surgery time
timeFrame: during surgery, day 1
measure: surgical quality based on material description and surgical technique
timeFrame: during surgery, day 1
Secondary outcomes:
measure: surgical quality based on robot precision
timeFrame: during surgery, day 1
measure: surgical quality based on the cochlear implantation in the cochlea
timeFrame: during surgery, day 1
measure: surgical quality based on intraoperative electrophysiological data
timeFrame: during surgery, day 1
measure: surgical quality based on pathological complications
timeFrame: during surgery and postoperative period (1.5 month after surgery)
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU amiens
name: Nathalie klopp-Dutote, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04058639: Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?
Official title: Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Bandages
Wound Healing
Time
Relief
Lead sponsor: Helse Møre og Romsdal HF
Sponsor class: OTHER_GOV
First posted: 2019-08-15
Enrollment: 74
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: block randomization
Primary purpose: TREATMENT

Brief summary: The Surgical Outpatient Clinic at Molde Hospital has since 2015 offered specialized treatment for patients with diabetic foot ulcers. This treatment is given by an interdisciplinary diabetic foot ulcer team. The standard treatment for diabetic foot ulcers is relief, a method with good results.

Although the treatment as usual gives good results, the team wants to optimize this treatment. By using custom felt relief for each patient, the treatment period might be reduced considerably. The aim of this study is therefore to investigate whether custom felt relief gives shorter processing time compared to standard relief treatment.


Eligibility criteria: Inclusion Criteria:

* diagnosed with Diabetes Mellitus Type 1 or 2
* has neuropathic wounds under the foot
* understands and speaks Norwegian well
* competent to give consent

Exclusion Criteria:

* responds to the filament glue and/or the tape used in treatment
* in need of vascular surgery intervention
* to be admitted to the hospital
* in need of intravenously administered antibiotics due to wound infection.

Primary outcomes:
measure: wound healing time in weeks
timeFrame: 2-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Molde
country: Norway
facility: Klinikk for Kirurgi Molde, Helse Møre og Romsdal HF
Study officials:
affiliation: Helse Møre og Romsdal HF
name: Tone Seim Fuglset, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT02146586: Clinical Evaluator Outcomes Reliability Study
Official title: Cooperative International Neuromuscular Research Group (CINRG) Clinical Evaluator Outcomes Reliability Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dystrophinopathies
Lead sponsor: Cooperative International Neuromuscular Research Group
Sponsor class: NETWORK
First posted: 2014-05-26
Enrollment: 55
Sex: MALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dystrophinopathies (Duchenne Muscular Dystrophy and Becker Muscular Dystrophy)

Brief summary: This study outlines structured Clinical Evaluator (CE) testing techniques that are proposed to be implemented across all sites participating in the Cooperative International Neuromuscular Research Group (CINRG) research studies. The study will determine if the selected techniques are reliable and reproducible across the CINRG network by evaluating the reliability and reproducibility of the measures between CEs


Eligibility criteria: Dystrophinopathy Participant Inclusion Criteria:

* Site confirmed genetic diagnosis of a dystrophinopathy
* Aged 6 years and older
* Able to transfer to testing table
* Able to walk 10 meters without an assistive device

Dystrophinopathy Participant Exclusion Criteria:

* Investigator assessment of inability to comply with protocol assessments
* Participants who have attention deficient disorder or other cognitive conditions that may limit attention span to perform protocol assessments

Primary outcomes:
measure: Clinical Evaluator Assessments
timeFrame: One time visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's National Research Institute
name: Lauren Morgenroth, MS, CGC
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Tina Duong, MPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02754986: Quantification of Autonomic Nervous Activity During Hemodialysis
Official title: Quantification of Autonomic Nervous Activity by Heart Rate Variability and Approximate Entropy in High Ultrafiltration Rate During Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease on Hemodialysis
Keywords: heart rate variability
Lead sponsor: University of Hyogo
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 35
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study assesses autonomic nervous system function by power spectral analysis of RR interval dynamics in ultrafiltration subjects without blood pressure variation.

Detailed description: Variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability in hemodialysis patients without blood pressure variations during HD session.

The subjects will be divided into 3 groups, those with UFR \< 10 ml/hr/kg; ≥10 ml/hr/kg but ≤ 15 ml/hr/kg; and \>15 ml/hr/kg, and Holter ECG are recorded continuously during HD session using frequency analysis of RR intervals.

Eligibility criteria: Inclusion Criteria:

* Patients with stable undergoing hemodialysis without hanging in blood pressure during hemodialysis.

Exclusion Criteria:

* Patients with chronic atrial fibrillation
* Patients with frequent ventricular premature beats
* Patients with a permanent pacemaker
* Patients with taking antihypertensive drugs
* Patients with medical treatment due to changes in blood pressure

Primary outcomes:
measure: The outcome measures was low frequency power (LF, ms2) to high frequency power (HF, ms2) ratio (LF/HF ratio) of heart rate variability. The three subject groups with difference ultrafiltration were compared by LF/HF ratio during hemodialysis session.
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Graduate School of Applied Informatics, University of Hyogo
state: Hyogo
Study officials:
affiliation: Graduate School of Applied Informatics, University of Hyogo
name: Yuko Mizuno-Matsumoto, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01211886: Utility of Brain Natriuretic Peptide (BNP) in Patients With Type IV Cardio-renal Syndrome Admitted to the Intensive Care Unit (ICU)
Official title: Utility of BNP in Patients With Type IV Cardio-renal Syndrome Admitted to the ICU: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Acute Heart Failure
Keywords: Brain natriuretic peptide
Cardio-renal syndrome
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2010-09-30
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease admitted to the ICU for acute heart failure (i.e., type IV cardio-renal syndrome)

Brief summary: Admission BNP was a useful marker for diagnosing and predicting type IV cardio-renal syndrome type IV in patients with chronic kidney disease admitted to the ICU for acute heart failure in a retrospective study. Therefore, we aim to prospectively investigate the utility of serum BNP in evaluating the treatment adequacy and predicting future cardiac events in patients with type IV CRS.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged \> 18 years, Patients with chronic kidney disease (Serum Cr \> 2.0, Documented medical history of chronic kidney disease

Exclusion Criteria:

* Cardiopulmonary resuscitation, Do-not-resuscitate state, Acute kidney injury, ICU stay \< 1 day

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06443086: Long-term Outcomes of Duodenal Adenocarcinoma From a Large Cohort
Official title: Long-term Survival Outcomes of Duodenal Adenocarcinoma: a Cohort Study With 15-year Single-center Experience
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastrointestinal Disease
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients included in this study were drawn from a hospital-based cohort and included cases diagnosed and treated at the facility. Inclusion criteria were histologically confirmed non-ampulla DA, including all stages of disease at diagnosis. Patients were excluded if they had ampulla cancer or other forms of gastrointestinal cancer, had incomplete medical records, or lost follow-up shortly after diagnosis. This rigorous selection process ensured the homogeneity of the study population and the relevance of the findings to non-ampulla DA.

Brief summary: The investigators will conducted a hospital-based cohort study in our 15-year experience with DA aimed at investigating the long-term outcomes of the patients with DA, along with analyzing the impact of the tumor characteristics, operations and adjuvant therapy on survival outcomes.

Detailed description: Numerous meta-analyses and systematic reviews have delved into the treatment of DA, yet the majority of the studies retrospective, single-center, and small sample size series, particularly in China. To bridge this knowledge gap, the investigators will conduct a hospital-based cohort study designed to investigate the long-term survival outcomes of the participants with the non-ampulla duodenal adenocarcinoma, and the effects of tumor characteristics, surgery, and adjuvant therapy on survival outcomes.

Eligibility criteria: Inclusion criteria:

(1) histologically confirmed non-ampulla DA;

Exclusion criteria:

1. had other gastrointestinal cancer;
2. had incomplete medical records, or lost follow-up shortly after diagnosis;
3. refused clinical data collection.

Primary outcomes:
measure: Median overall survival time
timeFrame: 2009.10-2023.06
measure: 3-year overall survival rate
timeFrame: 2009.10-2023.06
measure: 5-year overall survival rate
timeFrame: 2009.10-2023.06
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China
name: Hao Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01942486: Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
Official title: Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Migraine Disorders
Photophobia
Keywords: migraine
photophobia
light sensitivity
melanopsin cells
intrinsically photosensitive retinal ganglion cells
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Primary Children's Hospital
First posted: 2013-09-16
Enrollment: 35
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a special coating, applied to the surface of glasses can reduce the frequency and severity of migraine headaches in children and adolescents. This study is being conducted by researchers at Primary Children's Medical Center, The John Moran Eye Center, and the University of Utah Department of Electrical Engineering. The investigators have determined that a specific frequency of light is particularly bothersome to migraine patients. The coating they've developed is designed to block this frequency of light. Very few treatments are approved for the treatment of childhood migraine. The investigators hope that these glasses will provide a safe way to improve headaches in children.


Eligibility criteria: Inclusion Criteria:

1. Must be diagnosed with migraine with aura or migraine without aura
2. Must have at least 10 headache days per month

Exclusion Criteria:

1. Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity
2. Pregnant
3. Unwilling or unable in the judgment of the investigator to complete the study
4. Unavailable for any of the study visits
5. Light sensitive conditions: meningitis, iritis, blepharospasm, albinism
6. Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy
7. Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs
8. Best corrected visual acuity less than 20/40 in either eye

Primary outcomes:
measure: HIT-6 Score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Moran Eye Center
state: Utah
Study officials:
affiliation: University of Utah
name: Bradley Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00271986: Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection (LAR) for Recto-sigmoid Cancer
Official title: Intraperitoneal Microdialysis Monitoring of Patients During the Early Postoperative Period After LAR With Reference to Early Diagnosis of Anastomotic Leakage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Rectum
Keywords: Peritoneal microdialysis
Low anterior resection
Recto-sigmoid cancer
Anastomotic leakage
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2006-01-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing Loa Anterior Resection (LAR) or rectal cancer

Brief summary: Anastomotic leakage is a serious complication after LAR with high morbidity and mortality rates. Early diagnosis and treatment is mandatory. The primary aim of the present study is to investigate the clinical use of peritoneal microdialysis and whether is able to detect anastomotic leakage prior to clinical symptoms develops.

Detailed description: Patients undergoing LAR for recto-sigmoid cancer is subjected to peritoneal microdialyses during the postoperative period until discharge. Subcutaneous microdialysis serve as control. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient.

Patients undergoing abdomino-perineal rectal resection will serve as a control group.

A total of 50 patients will be included in this pilot study. The results of the peritoneal microdialyses will be compared with the clinical course in each patient. The results form the uncomplicated courses will be used to define the normal variations in peritoneal microdialysis. This will be compared to results from patients with various complications.

The study is approved by the local scientific ethical committee No. ------

Eligibility criteria: Inclusion Criteria:

* Histological verified cancer
* The cancer must be located in rectum or the sigmoid colon
* Diverting stoma is allowed
* Perioperative radio-chemotherapy is allowed

Exclusion Criteria:

* Disseminated cancer
* ASA-group 4 ore higher

Primary outcomes:
measure: anastomotic leakage
timeFrame: within 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Deparment A
Study officials:
affiliation: Odense University Hospital
name: Niels Qvist, Professor
role: STUDY_CHAIR
References: