louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04361643: Low-dose Lenalidomide for Non-severe COVID-19 Treatment Trial
Official title: Double-blind Randomized Controlled Clinical Trial of Low-dose Lenalidomide in the Treatment of COVID-19 Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double-blind randomized controlled clinical trial (RCT) of low-dose lenalidomide in the treatment of elderly patients (\> 60 years of age) with mild to moderate clinical signs of COVID-19 disease from the Hospital Universitario of Getafe.

The study will include patients of both sexes (\> 60 years of age) with mild to moderate clinical presentation of COVID-19 (ROX index \> 10). Subjects will be randomly assigned to the experimental arm with lenalidomide (5 mg/24h, day 1, 3 and 5) or to the controlled arm. Other concomitant medication for the treatment of COVID-19 will be also considered.


Eligibility criteria: Inclusion Criteria:

* Subjects \> 60 years of age
* Diagnosed case (PCR test for COVID-19 if available) or COVID-19 clinical symptoms (defined as fever, dry cough, dyspnea, chest radiography with compatible findings with COVID-19)
* Lymphocyte count ≥ 0.2 x 103/µL and ≤1.0 x 103/µL.
* Neutrophil count ≥ 1.8 x 103/µL, platelets ≥ 150 x 103/µL.
* ROX ≥ 10 index
* Signed informed consent document
* Willing to comply with the lenalidomide Risk Minimization Program (Pregnancy Prevention Program approved)

Exclusion Criteria:

* Absolute contraindication of lenalidomide use or hypersensitivity to the active ingredient or any of the excipients.
* Active neoplasia
* Previous autoimmune disease
* Concurrent infection of HBV, HCV or tuberculosis.
* Aspartate transaminase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal (ULN).
* Bilirubin levels \> 1.5 times the ULN
* Renal impairment with an estimated GF \< 30ml/min
* Venous thromboembolism events within the previous 3 years
* Significant active heart disease within the previous 6 months, including congestive heart failure (class II-IV NYHA), unstable angina or myocardial infarctions
* Sexually active subjects who refuse the lenalidomide Risk Minimization Program
* Inability to comply with the working protocol under the responsible health professional opinion.

Primary outcomes:
measure: Clinical improvement
timeFrame: 30 days
measure: Immune-inflammatory improvement
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
Study officials:
affiliation: Hospital Universitario Getafe
name: Joaquin De Haro, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03832543: Modified Uterosacral Ligament Suspension in Vaginal Hysterectomy
Official title: Modified Extraperitoneal Uterosacral Ligament Suspension in Preventing Cuff Prolapse Risk After Vaginal Hysterectomy; 4 Clamp Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Modified Extraperitoneal Uterosacral Ligament Suspension
Vault Prolapse, Vaginal
Keywords: Vaginal Hysterectomy
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stage 2 or 3 uterin prolapse who need surgery

Brief summary: Introduction : The extraperitoneal uterosacral ligament suspension (ULS) can be performed during the removal of the uterus in vaginal hysterectomy to prevent cuff prolapse. In this study, the modified extraperitoneal ULS technique was evaluated in terms of preventing cuff prolapse.

Methods / Technique : Forty patients with second and third-stage uterine prolapse who were operated were included in the study. During routine vaginal hysterectomy procedure performed on patients, after sacrouterine ligaments which are the first-bites and uteroovarian and round ligaments which are the last-bites have been sutured and knotted, these ligaments were marked with 4-distinct clemps to make the right and left, upper and lower separation. After vaginal cuff was closed the sutures hanged by the clamps were ligated together, and the cuff tissue was stretched to the apical line.


Eligibility criteria: Inclusion Criteria:

* Stage 2 or 3 uterin prolapse

Exclusion Criteria:

* contrandication for surgery

Primary outcomes:
measure: postoperative vaginal cuff prolapse
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03692143: Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP
Official title: Effect and Cost Comparation of Different Treatment Strategies for Osteoporotic Vertebral Fractures (OVF): Teriparatide Injection and Percutaneous Vertebroplasty (PVP)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoporosis, Postmenopausal
Vertebral Fracture
Quality of Life
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 90
Sex: FEMALE
Minimum age (years): 49
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: postmenopaual women with osteoporotic vertebral fractures, reveived treatments with teriparatide, PVP, teriparatide after PVP, or fosamax only.

Brief summary: This study aimed to compare teriparatide treatments and PVPs, focusing on its effects on life qualities and effect/coast ratio and evaluate which method is better for patients.

Detailed description: Osteoporosis and osteoporotic vertebral fracture (OVF)s are the common diseases that affect the qualities of senior people. The general treatments for OVFs including percutaneous vertebroplasty (PVP) operation and conservative treatments with pain killers. But with the widely used methods, the life quality of patients were still not satisfied. Teriparatide has been proven to increase bone qualities in patients with severe osteoporosis and reduced the fracture possibilities. The investigators' previous clinical observation found teriparatide could be applied to treat fresh OVFs.

90 participants who diagnosed fresh OVFS were included in the trial. After they received each of three kinds of interventions mentioned in this study, The investigators followed up all these cases. Once 30 cases goal reaches in a certain group, the data collection in that special will stop automatically. The quality of life, pain score and BMDs will be evaluated in certain time during the trial.

Eligibility criteria: Inclusion Criteria:

* 1.postmenopausal women with osteoporotic fractures 2.treated with teriparatide 3.or treated with vertebroplasty 4.or treated with teriparatide after vertebroplasty 5.or treated with Fosamax 6. willing to anticipate the trial

Exclusion Criteria:

* Serious other illness or disease which effecting quality of life occurs later in treatment
* unwilling to anticipate the trial

Primary outcomes:
measure: Quality of life of the patients
timeFrame: Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment
Secondary outcomes:
measure: Pain cause by the fracture
timeFrame: Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment
measure: Bone healing
timeFrame: 3 month after treatment
measure: Bone mineral density
timeFrame: Change from pre treatment at 6 months, 1 year and 2 years post treatment
Other outcomes:
Locations:
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Dehong Yang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00888238: A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179)
Official title: A Randomized Clinical Trial to Evaluate Glucose-Dependent Insulinotropic Effects of a Single Dose of a DPP-4 Inhibitor in Lean Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-04-27
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure.


Eligibility criteria: Inclusion Criteria:

* Subject is an Asian Indian male between 18 to 45 years of age
* Subject is in good health
* Subject is a nonsmoker or has not used nicotine-containing products for six months
* Subject is willing to avoid strenuous activity

Exclusion Criteria:

* Subject has a history of stroke, seizures, or major neurological disorders
* Subject has irritable bowel disease or recurrent nausea, vomiting, diarrhea, or abdominal pain
* Subject has a history of high blood pressure requiring treatment
* Subject has history of cancer
* Subject has a history of diabetes

Primary outcomes:
measure: Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose
timeFrame: 190 minutes to 340 minutes
Secondary outcomes:
measure: Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose
timeFrame: 190 minutes to 340 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Shankar SS, Shankar RR, Mixson LA, Miller DL, Steinberg HO, Beals CR, Kelley DE. Insulin secretory effect of sitagliptin: assessment with a hyperglycemic clamp combined with a meal challenge. Am J Physiol Endocrinol Metab. 2018 Apr 1;314(4):E406-E412. doi: 10.1152/ajpendo.00238.2017. Epub 2017 Nov 14.
Clinical trial NCT01148238: Autoimmune Diabetes: Markers of the Disease and Treatment of Latent Autoimmune Diabetes in Adults (LADA)
Official title: Autoimmune Diabetes: Disease Markers and Treatment of Latent Autoimmune Diabetes in Adults (LADA)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Autoimmune Diabetes
Keywords: Autoimmune diabetes
LADA
T-reg
cytokine
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 10 patients with newly diagnosed diabetes type 1. 10 healthy age- and sex matched blood donors.

10 patients with LADA. 10 healthy age- and sex matched blood donors. 10 patients with diabetes type 1 older than 10 years. 10 healthy age- and sex matched blood donors.

Brief summary: Autoimmunity is the main cause of diabetes type 1 and an important factor as cause of Latent Autoimmune Diabetes in Adults (LADA). Recently, research has found that being deficient of T-reg cells is an important cause of autoimmunity. The study hypothesis are:

1. Patients with newly found diabetes type 1 have less T-reg than healthy.
2. Patients with newly found diabetes type 1 have less T-reg than patients with long duration of the illness.
3. The number of T-reg is negative associated with HLA-risk-haplotype.
4. The number of T-reg is negative associated with LADA.
5. Differences relating to inflammatory cytokines will be seen among patients with newly found diabetes type 1, but not among others.

Detailed description: Research has worked out that b-cells are being destroyed by cytokines released from inflammatory cells. One hypothesis in that T-reg is a cause of autoimmunity, and that T-reg concentrations are low in patients with newly diagnosed diabetes type 1.

Blood samples will be taken from 10 patients with newly diagnosed type 1 diabetes, Latent Autoimmune Diabetes in Adults (LADA) and type 1 diabetes older than 10 years and the same amount of samples from healthy, age- and sex-matched blood donors. Markers of autoimmune diabetes will be analyzed.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed diabetes type 1
* LADA
* diabetes type 1 older than 10 years

Exclusion Criteria:

* none

Primary outcomes:
measure: T-reg
Secondary outcomes:
measure: HLA, anti-GAD, anti-IA2, white blood count, CRP, fasting C-peptide, HbA1c
Other outcomes:
Locations:
Study officials:
affiliation: Department of Cancer Research and Molecular Medicine
name: Valdemar Grill, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05858138: To Explore the Effectiveness of Jing-Si Herbal Tea Against Non-alcoholic Fatty Liver Disease
Official title: To Explore the Effectiveness of Jing-Si Herbal Tea Against Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: Jing-Si Herbal Tea
Lead sponsor: Taichung Tzu Chi Hospital
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to explore the effectiveness of Jing-Si Herbal Tea on improving the Non-alcoholic fatty liver disease patients

Detailed description: This study adopted a randomized double-blind design, 2-arm trial study. All eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC110-74). Patients were recruited from the Gastroenterology department of Taichung Tzu Chi hospital. After random assignment to 2 groups, patients will receive Jing-Si Herbal Tea or placebo twice a day for 24 weeks. We will evaluate the blood test results, abdominal ultrasound and physical examination every 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Sign the Informed consent
* Age between 20-70
* Diagnosis for moderated NAFLD
* Liver disease without hepatic decompensation
* HbA1c \< = 8.0 %

Exclusion Criteria:

* Do not sign the Informed consent
* Other related liver diseases will affect the study which evaluated by physicians
* Women of potential pregnancy or pregnant women

Primary outcomes:
measure: Assessing the changes from baseline blood glucose at 24 week
timeFrame: 24 week
measure: Assessing the changes from baseline GOT (Glutamic Oxaloacetic Transaminase) at 24 week
timeFrame: 24 week
measure: Assessing the changes from baseline GPT (Glutamic Pyruvic Transaminase) at 24 week
timeFrame: 24 week
measure: Assessing the changes from baseline total cholesterol at 24 week
timeFrame: 24 week
measure: Assessing the changes from baseline triglycerides at 24 week
timeFrame: 24 week
measure: Assessing the changes from baseline HDL-C at 24 week
timeFrame: 24 week
measure: Assessing the changes from baseline LDL-C at 24 week
timeFrame: 24 weekk
measure: Assessing the changes from baseline NAFLD activity at 24 week
timeFrame: 24 week
measure: Assessing the changes from baseline BMI at 24 week
timeFrame: 24 week
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Tzu Chi Hospital
Study officials:
References:
Clinical trial NCT04926038: Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Emergency Surgery
Official title: Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Emergency Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Death
Keywords: Postoperative death
Emergency surgery
Prediction model
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
name: Henan Provincial People's Hospital
name: Xiangya Hospital
name: Shanxi Bethune Hospital
First posted: 2021-06-14
Enrollment: 200000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Undergoing Emergency Surgery

Brief summary: The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after emergency surgery.

The investigators identify all patients treated with emergency surgery, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data.

60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.


Eligibility criteria: Inclusion Criteria:

* Patients Undergoing Emergency Surgery

Exclusion Criteria:

* Patients with incomplete electronic medical record information

Primary outcomes:
measure: Postoperative Death
timeFrame: The mortality within 5 years after the emergency surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention
state: Beijing
city: Zhengzhou
country: China
facility: Henan People's Hospital, Henan, China
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Hunan, China
state: Hunan
city: Taiyuan
country: China
facility: Shanxi Bethune hospital, Shanxi, China
state: Shanxi
Study officials:
References:
Clinical trial NCT02754843: Quality Control of CE-Labelled Phonak Hearing Systems (Study Part: Sonova2015-00)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study, which contains a series of successive study parts, is to methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality control prior to each product launch.


Eligibility criteria: Inclusion Criteria:

* Hearing impaired persons with and without (experience with) hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Central hearing disorders

Primary outcomes:
measure: Speech intelligibility in quiet. Discrimination [%]
timeFrame: One week.
measure: Speech intelligibility in noise. Speech Reception Threshold [dB SNR]
timeFrame: One week.
Secondary outcomes:
measure: Phoneme Perception Test, test no. 1.
timeFrame: Four weeks
measure: Phoneme Perception Test, test no. 2.
timeFrame: Four weeks
measure: Phoneme Perception Test, test no. 3.
timeFrame: Four weeks
measure: Diary to describe hearing impressions in everyday life
timeFrame: Six weeks
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Canton Zürich
Study officials:
affiliation: Sonova AG
name: Simone Ebbing, B.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03594643: Electronic Cigarette and Surgery (ECigarSurg)
Official title: Electronic Cigarette and Perianesthesia : a Prospective Multicentric Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoke Inhalation
Keywords: electronic
surgery
outcome
anesthesia
cigarette
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Institut du Cancer de Montpellier - Val d'Aurelle
First posted: 2018-07-20
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - This study include patients scheduled for elective surgery

Brief summary: Since decades, literature has shown that smoking has negative effect on postoperative outcome. Recent systematic review and meta-analysis on clinical impact of smoking and smoking cessation showed that postoperative healing complications occur more often in smokers compared with nonsmokers.

The use of electronic cigarette (e-cigarette) is spreading through the world. Despite this fact, the health risk assessment studies on e-cigarette are limited and scientific evidences are inconsistent.

This prospective multicenter study aimed at assessing the use of e-cigarette whether patient undergoing elective surgery. The main objective of this study was to evaluate the prevalence of e-cigarette consumer in perioperative period. Secondary objectives were to analyze when patients consume e-cigarette in regard of surgery, how many dose they consume and if they also consume nicotine cigarette.

Detailed description: this study used a standardized questionnaire that was filled in preoperative period

Eligibility criteria: Inclusion Criteria:

* protocol approval
* patients scheduled for elective surgery

Exclusion Criteria:

* \< 18 ans
* refusal
* not speaking
* emergency surgery

Primary outcomes:
measure: electronic cigarette
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Cuvillon
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: jean.yves. Lefrant, MD,PhD
role: STUDY_CHAIR
References: