louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06699407: Qishenyiqi for Ventricular Remodeling After Myocardial Infarction
Official title: Efficacy and Safety of Qishenyiqi Dripping Pills in Patients With Ventricular Remodeling and Chronic Heart Failure With Reduced Ejection Fraction After Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Chronic Stable Heart Failure
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effects of Qishenyiqi dripping pill on cardiac remodeling in patients with chronic stable heart failure have not been reported. This project aims to clarify the efficacy and safety of Qishenyiqi in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure after myocardial infarction were selected and randomly divided into two groups: the treatment group was treated with Qishenyiqi dripping pills; The control group was given placebo treatment. After 12 months of follow-up, the effects of Qishenyiqi on cardiac remodeling and function and cardiovascular adverse events were evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure.


Eligibility criteria: Inclusion Criteria:

* 1) The history of acute myocardial infarction exceeds 3 months;
* 2) Symptoms and signs of heart failure have been stable for more than one month;
* 3) 18 years old or more;
* 4) NYHA cardiac function classified as grade II\~IV;
* 5) LVEF≤40%；
* 6) NT-proBNP≥450pg/ml；
* 7) All subjects or their guardians must sign the subject consent before entering the trial.

Exclusion Criteria:

* 1) Patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor;
* 2) Planned to undergo cardiac surgery within 12 months;
* 3) Mechanical complications of myocardial infarction;
* 4) Pregnant or nursing, or having the intention to give birth within one year;
* 5) Patients who participated in clinical research of other drugs within 3 months before being selected;
* 6) Patients with poor sound transmission windows are examined by transthoracic ultrasound.

Primary outcomes:
measure: LVEDVI=LVEDV/BSA
timeFrame: From baseline to 12 months after follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Panpan Hao
state: Shandong
city: Jinan
country: China
facility: Qianfoshan Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital Affiliated to Shandong First Medical University
Study officials:
References:
Clinical trial NCT00319007: Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis
Official title: Adenoma-Carcinoma Sequence in the Ileal Pouch Anal Anastomosis in Patients With Familial Adenomatous Polyposis: Studies on Luminal and Mucosal Risk Factors and Chemoprevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Adenomatous Polyposis Coli
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2006-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether sulindac and VSL#3 - inulin, either combined or alone, are effective in treating or preventing adenoma development in the ileal anal pouch in patients with familial adenomatous polyposis.


Eligibility criteria: Inclusion Criteria:

* Clinically or genetically proven familial adenomatous polyposis
* Restorative proctocolectomy with ileal pouch anal anastomosis

Exclusion Criteria:

* Chronic or acute renal or hepatic disease
* History of oesophageal, gastric or duodenal ulcers
* Known hypersensitivity to sulindac
* Daily use during the last three months of:
* Aspirin
* Non-Steroidal Anti-Inflammatory Agents
* Probiotics

Primary outcomes:
measure: Pouch mucosal proliferation index at 0, 1 and 2 months
measure: Pouch mucosal apoptosis index at 0, 1 and 2 months
Secondary outcomes:
measure: Pouch mucosal Glutathione S transferases activity and isoenzyme levels at 0, 1 and 2 months
measure: Faecal genotoxicity at 0, 1 and 2 months
measure: Faecal cytotoxicity at 0, 1 and 2 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Fokko M Nagengast, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04082507: Maternal Serum Alpha-fetoprotein Level May Predict the Presence of Morbid Adherent Placenta
Official title: Alpha-fetoprotein as a Biochemical Marker in Prediction of Placenta Acreta Increta Percreta
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Accreta
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 150 pregnant women from 28wk to full term who are attending outpatient clinic and emergency room ain shams university maternal hospital

Brief summary: The aim of the study is to compare between alpha-fetoproteine as a biological marker and between ultrasound and Doppler in prediction of morbid adherent placenta.

Detailed description: in pregnant women withe previous cesarean section, placenta previa and ultrasonographic finding of an abnormally adherent placenta dose maternal serum alpha-fetoprotein predict prenataly the presence of morbid adherent placenta accurately?

Eligibility criteria: Inclusion Criteria:

* pregnant women with history of scarred uterus

  * plcenta previa covering the scar of previous caesarean section as diagnosed by 2DU/S
  * Gestational age from 28wks to full term

Exclusion Criteria:

* pregnant women with fetus with congenital anomalies

  * pregnant women with ovarian swelling
  * pregnant women with medical disease

Primary outcomes:
measure: Maternal serum alpha-fetoprotein
timeFrame: From 28weeks to 37 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university maternity hospital
Study officials:
References:
Clinical trial NCT05351307: Retinal Vascular Changes in Primary Open Angle Glaucoma Patients
Official title: Retinal Vascular Changes in Primary Open Angle Glaucoma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Open Angle Glaucoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: \> 18 years primary open angle glaucoma patients

Brief summary: the study aims to detect ischemic changes in macula using OCT angiography in primary open angle glaucoma patients correlating with glaucoma staging system II by visual field.

Detailed description: Our study will be designed as " prospective non-randomized case - control study" The study will include 100 eyes of 100 participants 50 eyes of normal subjects , non-glaucomatous subjects 50 eyes of 50 patients with POAG To detect ischemic changes in macula using OCT angiography correlating with glaucoma staging system II by visual field.

Eligibility criteria: Inclusion Criteria:

* (\> 18 years old)

Exclusion Criteria:

* patients with cataract
* retinal disorders including: AMD , Macular degeneration , retinal detachment , retinitis pigmentosa , etc .
* corneal opacites
* any ocular surgeries
* patients with systemic disease.
* patient refusal

Primary outcomes:
measure: ischemic changes in macula
timeFrame: Through one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
affiliation: Supervisor
name: Mohamed Iqbal Hafez, Assist prof
role: STUDY_DIRECTOR
affiliation: Supervisor
name: Hany Mahmoud Abdel Hamid, Lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT02987907: The Impact on Therapeutic Effect and Tolerance of Treatment for Patients With Hepatocellular Carcinoma in Transcatheter Arterial Chemoembolization (TACE) of Dexamethasone Application: A Random, Double-blind, Controlled, Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HepatoCellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current random, double-blind, controlled, clinical trial was designed to evaluate the impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application.


Eligibility criteria: Inclusion Criteria:

* older than 18 years old;
* ECOG PS\<3;
* proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
* meeting at least 1/4: 1) multiple nodules, 2) single tumor but not suitable for resection, 3) vascular invasion exists, 4) distant metastasis excluding CNS and bone
* not previous treated for tumor;
* Child-Pugh A or B;
* at least one measurable lesion according mRECIST;
* cannot afford sorafenib;
* the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\<3-times upper limit of normal; ALT\<5-times upper limit of normal; AST\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3
* sign up consent;
* unrolled by other clinical trials about hepatocellular carcinoma.

Exclusion Criteria:

* cannot tolerate TACE;
* CNS or bone metastasis exits;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorrage or cardiac/brain vascular events within 30 days;
* pregnancy;

Primary outcomes:
measure: response rate (RR)
timeFrame: 1 month after TACE
measure: proportions of participants with severe adverse events according to CTCAE v4.03
timeFrame: 1 month after TACE
Secondary outcomes:
measure: overall survival (OS)
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
measure: progression-free survival (PFS)
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
measure: time to progression (TTP)
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03299907: COPD MSA 3 Regions: Epidemiology and Risk Factors of COPD in Rural Environment (BM3R)
Official title: COPD MSA 3 Regions: Epidemiology and Risk Factors of COPD in Rural Environment (BPCO MSA 3Régions : épidémiologie et Facteurs de Risque de la BPCO en Milieu Rural)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Mutualité sociale agricole
First posted: 2017-10-03
Enrollment: 5263
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data were collected between October 2012 and May 2013 in two French regions (Brittany and Franche-Comté) among affiliated members (farmers and administrative workers of both sexes) of the MSA.

Brief summary: The agricultural environment presents a unique profile in terms of epidemiology of pulmonary diseases. Certainly due to persistent exposure to organic particles, the prevalence of COPD is higher in farmers than in the general population, despite less smoking. It is likely that the risk of COPD depends on several factors, such as the type of farm, local conditions and the region where the farm is located. It is important to diagnose COPD at an early stage in order to initiate appropriate therapy, and implement secondary prevention with a view to limiting deterioration of respiratory function and reducing complications. In this context, the aims of BM3R project were: (1) to study the epidemiology of COPD in a large representative sample of French farmers, in order to identify the types of farming, working conditions and regions that are associated with the presence of COPD; and (2) to develop a score to identify patients at risk and optimise diagnosis of COPD in the context of a screening programme.


Eligibility criteria: Inclusion Criteria:

* \> 40 years old and \< 75 years old
* Affiliated to the MSA

Exclusion Criteria:

* COPD known

Primary outcomes:
measure: FEV1/FVC
timeFrame: At the inclusion time
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU Besançon
name: Bruno DEGANO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03437109: Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus
Official title: Clinical and Epidemiological Characteristics and Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus Under Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: T2DM (Type 2 Diabetes Mellitus)
Hypogonadism
Lead sponsor: Besins Healthcare
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 554
Sex: MALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men with T2DM aged between 45-60 years old

Brief summary: The purpose of the study is to get data of prevalence of testosterone deficiency in patient with T2DM in Russian Federation

Detailed description: Clinical and Epidemiological Characteristics and Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus Under Routine Clinical Practice (DESTINY)

Eligibility criteria: Inclusion Criteria:

* Male 45-60 years old
* Diagnosis of T2DM according to approved standards
* Signed Informed Consent Form

Exclusion Criteria:

* Prepubertal hypogonadism of any genesis;
* Sexual and developmental disorders;
* Absence of at least one of the testicles;
* Cryptorchidism, including in the anamnesis;
* Injuries and / or surgical interventions on the genitals with loss of at least one of the testicles;
* Established diagnosis of panhypopituitarism in accordance with current recommendations / standards;
* Androgen therapy, administered at the time of the study or in the anamnesis;
* Admission of anabolic steroids;
* Alcoholism or drug addiction;
* Insolvency.

Primary outcomes:
measure: The prevalence of hypogonadism in patients with T2DM
timeFrame: 2017-2018
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: ENC
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital
Study officials:
affiliation: ENC
name: Marina SHESTAKOVA, academitian
role: STUDY_CHAIR
References:
Clinical trial NCT01115309: XprESS Registry Study
Official title: XprESS Registry Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Keywords: Sinusitis
Lead sponsor: Entellus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 175
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: This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).

Detailed description: Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients.

One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use
* Willing and able to provide consent

Exclusion Criteria:

* Known Samter's Triad
* History of primary ciliary dysfunction
* History of cystic fibrosis
* Known to be immunosuppressed
* Hemophilia
* Currently enrolled in another pre-approval investigational study

Primary outcomes:
measure: Safety Assessments
timeFrame: 1 month after procedure
Secondary outcomes:
measure: Sino-Nasal Outcome Test (SNOT-20) at 1 Month
timeFrame: Baseline and 1 month after procedure
measure: SNOT-20 at 6 Months
timeFrame: Baseline and 6 months post procedure
measure: SNOT-20 at 12 Months
timeFrame: Baseline and 12 months post procedure
Other outcomes:
measure: Number of Sinuses Demonstrating Functional Patency
timeFrame: 12 months post procedure
Locations:
city: San Antonio
country: United States
facility: Texas Sinus Center
state: Texas
Study officials:
affiliation: Entellus Medical
name: Jeff Grebner
role: STUDY_CHAIR
References:
citation: Brodner D, Nachlas N, Mock P, Truitt T, Armstrong M, Pasha R, Jung C, Atkins J. Safety and outcomes following hybrid balloon and balloon-only procedures using a multifunction, multisinus balloon dilation tool. Int Forum Allergy Rhinol. 2013 Aug;3(8):652-8. doi: 10.1002/alr.21156. Epub 2013 Feb 19.
Clinical trial NCT02663609: Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome
Official title: Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cushing's Syndrome
Keywords: Cushing's Syndrome
Mifepristone
Adrenal
Retrospective
Chart Review
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-01-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ACTH Independent Cushing's Syndrome patients treated with Korlym® mifepristone) as standard of care in clinical practice.

Brief summary: Chart review study to collect patient data from medical charts of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome.

Detailed description: A retrospective, multi-center, chart review study to collect patient data from medical charts of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome. Treatment with Korlym® will be a minimum 3 months in duration with follow-up of a minimum 3 months. Only sites that have been identified to have patients appropriate for this protocol will be invited to participate.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with ACTH independent endogenous Cushing's Syndrome
* Available adrenal imaging prior to being treated with Korlym®
* Treated with Korlym® and followed for at least 3 months (follow-up data should be available)

Exclusion Criteria:

* Diagnosed with adrenocortical carcinoma
* Participant in any clinical trial(s) during the observational period

Primary outcomes:
measure: Drug Utilization Patterns as assessed by chart review
timeFrame: up to 4 years
Secondary outcomes:
measure: Clinical Outcomes as assessed by chart review
timeFrame: up to 4 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04715009: Smartphone Use and Neck Flexion Angle
Official title: The Effect of Smartphone Use on Neck Flexion Angle and Hand Grip Power Among Adolescence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Disorder
Keywords: smartphone
neck flexion
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 140
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy volunteers using smartphone less or more than 4 hours per day have not any signes of musculoskeletal problems

Brief summary: Excessive smartphone use can disrupt your sleep, which can have a serious impact on your overall mental health. It can impact your memory, affect your ability to think clearly, and reduce your cognitive and learning skills. Encouraging self-absorption.

Detailed description: Persistent failed attempts to use cell phone less often. Preoccupation with smartphone use. Turns to cell phone when experiencing unwanted feelings such as anxiety or depression. Excessive use characterized by loss of sense of time.

Nomophobia-an abbreviation of "no-mobile-phone-phobia"-is also called "cell phone addiction." Symptoms include: Experiencing anxiety or panic over losing your phone. Obsessively checking for missed calls, emails, and texts.

Eligibility criteria: Inclusion Criteria:

* volunteers using smartphone less or more than 4 hours per day

Exclusion Criteria:

* low back pain surgeries affecting upper limps

Primary outcomes:
measure: the neck flexion angle
timeFrame: the neck flexion angle at day 0
measure: the neck flexion angle
timeFrame: the neck flexion angle at day 120
Secondary outcomes:
measure: hand grip power
timeFrame: power of hand at date 0
measure: hand grip power
timeFrame: power of hand at date 120
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Nehad ahmed youness
Study officials:
affiliation: South Valley University, Faculty of Physical Therapy
name: Nehad A Abo-zaid, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonney RA, Corlett EN. Head posture and loading of the cervical spine. Appl Ergon. 2002 Sep;33(5):415-7. doi: 10.1016/s0003-6870(02)00036-4.
citation: Janwantanakul P, Sitthipornvorakul E, Paksaichol A. Risk factors for the onset of nonspecific low back pain in office workers: a systematic review of prospective cohort studies. J Manipulative Physiol Ther. 2012 Sep;35(7):568-77. doi: 10.1016/j.jmpt.2012.07.008. Epub 2012 Aug 24.
citation: Hansraj KK. Assessment of stresses in the cervical spine caused by posture and position of the head. Surg Technol Int. 2014 Nov;25:277-9.
citation: Grimmer-Somers K, Milanese S, Louw Q. Measurement of cervical posture in the sagittal plane. J Manipulative Physiol Ther. 2008 Sep;31(7):509-17. doi: 10.1016/j.jmpt.2008.08.005.