louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05905016: Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
Official title: Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Achalasia
Esophageal Spasm, Diffuse
Gastroparesis
Swallowing Disorder
Zenker Diverticulum
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 600
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: Patient who present to the Center for Interventional Endoscopy for standard of care POEM procedures.

Brief summary: This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

Detailed description: This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

This study will enroll 600 subjects over the next 4 to 5 years.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older.
2. Scheduled to undergo POEM

Exclusion Criteria:

1. Any contraindication to performing endoscopy.
2. Participation in another research protocol that could interfere or influence the outcomes measures of the present study.

Primary outcomes:
measure: Post procedural Reflux Rate
timeFrame: 12 months
measure: Long-Term Clinical Efficacy of G-POEM for the management of medically refractory gastroparesis
timeFrame: 12 months
measure: Long-Term Clinical Efficacy of Z-POEM for the management of Zenker's Diverticulum and Rate of Recurrence
timeFrame: 12 months
measure: Evaluate the efficacy of POEM for the management of gastrointestinal disease for esophageal motility.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
Study officials:
affiliation: AdventHealth Orlando
name: Dennis Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00248924: Outcomes Of Social Service Programs For Homebound Older Adults
Official title: Outcomes Of Social Service Programs For Homebound Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Homebound
Elderly
Keywords: Social service intervention
Social support
Elderly
Homebound
Quality of life
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: The New York Community Trust
First posted: 2005-11-04
Enrollment: 56
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The objective of this prospective study is to document the impact of social service interventions (including meals, telephone reassurance, and friendly visiting)provided by the Burden Center, a model community social service agency, on overall quality of life.

Detailed description: Specific outcomes include mental and physical function as measured by the SF-36, and depressive symptoms as measured by the CES-D depression scale. The hypothesis is that a multicomponent social service intervention program that provides social support and reduces social isolation can prevent depression and decline in quality of life in this vulnerable population.

Eligibility criteria: Inclusion Criteria:

* All new clients of the Burden Center for the Aging who are homebound, out of the home less than one time per week, and cognitively intact will be eligible for enrollment.

Exclusion Criteria:

* Clients unable to give informed consent such as those suffering from a major psychiatric disease or those who are not cognitively able to give informed consent will be excluded.
* Clients who refuse to participate will be excluded

Primary outcomes:
measure: Quality of life Depressive symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Presbyterian Hospital-Weill Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mary E Charlson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Charlson ME, Peterson JC, Syat BL, Briggs WM, Kline R, Dodd M, Murad V, Dionne W. Outcomes of community-based social service interventions in homebound elders. Int J Geriatr Psychiatry. 2008 Apr;23(4):427-32. doi: 10.1002/gps.1898.
Clinical trial NCT04930224: Serum GPER-1 and Oxidant/Antioxidant Levels on Retinopathy in Diabetic Patients
Official title: Comparing the Impact of Serum GPER-1 and Oxidant/Antioxidant Levels on Retinopathy in Diabetic Patients and Healthy Individuals: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Diabetic Retinopathy
Hormones
Keywords: Diabetic retinopathy
GPER-1
oestradiol
progesterone
TSH
oxidative stress
neuronal damage.
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People who applied to the tertiary eye outpatient clinic

Brief summary: Observational, comparative, cross-sectional study

Detailed description: This study was conducted on G protein-mediated estrogen receptor 1 (GPER-1), which is thought to be effective in preventing the development of diabetic retinopathy (DR). There are studies proving that GPER-1 prevents neuroprotective effects and vascular pathology in many tissues. In the study, serum GPER-1 and oxidative stress biomarker levels were compared in diabetic patients and healthy control groups. GPER-1 was found to be significantly increased in diabetic patients. In addition, a positive correlation was found with oxidant markers. This may lead to new treatment models in the future.

Eligibility criteria: Inclusion Criteria:

* 40 individuals were required to have Proliferative Diabetic Retinopathy (PDR);
* 40 were required to have Non-PDR;
* 40 were required to be healthy, without any systemic disease.

Exclusion Criteria:

* Glaucoma,
* Ocular trauma sequelae,
* Pathological myopia,
* Non-diabetic retinopathy,
* A history of previous ocular surgery,
* Endocrine disorders (e.g.,thyroidopathy, adrenal gland disorders, pituitary pathologies),
* Opacities interfering with fundus examination (e.g., corneal opacity, lens opacity, vitreous cloudiness other than diabetic haemorrhage).

Primary outcomes:
measure: G receptor-mediated protein-1 (GPER-1)
timeFrame: Baseline
measure: Oxidative/antioxidative stress markers (malondialdehyde [MDA])
timeFrame: Baseline
measure: Oxidative/antioxidative stress markers (catalase [CAT])
timeFrame: Baseline
measure: Oxidative/antioxidative stress markers (superoxide dismutase [SOD]
timeFrame: Baseline
measure: Thyroid stimulating hormone (TSH)
timeFrame: Baseline
measure: Progesterone
timeFrame: Baseline
measure: oestradiol
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaras
country: Turkey
facility: Abdullah Beyoğlu
state: None Selected
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Abdullah Beyoğlu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02283424: Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With EGFR Gene Mutation
Official title: A Randomized ,Opened, Prospective Controlled Trial of Clinical Effectiveness for Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Gene Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neoplasms, Therapy-Associated
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized ,opened, prospective controlled trial of clinical effectiveness for Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma patients with epidermal growth factor receptor gene mutation

Detailed description: In this trial the investigators will enlist 100 patients who accepted surgery and with epidermal growth factor receptor gene mutation,these patients will be divided into 2 groups (chemotherapy group and Icotinib group),compare the PFS,RFS,OS after 5 years follow up

Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* Lung adenocarcinoma patients with epidermal growth factor receptor gene mutation,stage I-IIIB after surgery
* The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2

Exclusion Criteria:

* Mismatch conditions above
* Have used other anti-cancer therapy drug before the trial and may influence the outcome

Primary outcomes:
measure: Recurrence-free Survival
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: 6 months
Other outcomes:
Locations:
city: BeiJing
country: China
facility: PLA General Hospital
Study officials:
affiliation: PLA General Hospital
name: Yang Liu, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT03632824: Tranexamic Acid in Pregnancies With Vaginal Bleeding
Official title: Tranexamic Acid for Antepartum Bleeding of Unknown Origin in the Second and Third Trimester: Nonrandomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Bleeding During Pregnancy
Keywords: Antepartum bleeding
Perinatal morbidity
Perinatal mortality
Preterm labor
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 139
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Tranexamic acid was prescribed for pregnant women with vaginal bleeding of unknown etiology in second and third trimester (13-34 weeks) gestation
Primary purpose: TREATMENT

Brief summary: Tranexamic acid has been proposed and used for prevention and management of antepartum and postpartum hemorrhage.

Detailed description: Bleeding during pregnancy is associated with a three- to fourfold increase in perinatal mortality. Hemorrhage in pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis, and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is category B. Tranexamic acid has been used to decrease blood loss and treatment of intra partum blood loss in cesarean section also it has been used for prevention and management of postpartum hemorrhage after vaginal bleeding, regardless of whether the bleeding is due to genital tract trauma or other causes.

Eligibility criteria: Inclusion Criteria:

* pregnant woman having vaginal bleeding
* Second and third trimester of unknown etiology
* No placenta previa, abruptio placentae, local cervical or vaginal causes for bleeding
* Primigraivid, multiparous and grand multiparous woman
* Accept to participate in the trial

Exclusion Criteria:

* Hypersensitivity to tranexamic acid
* Women with acquired defective color vision
* History of venous thromboembolism
* Refused to participate

Primary outcomes:
measure: Cessation of vaginal bleeding as self-reported by women
timeFrame: 7 days
measure: Gestational age
timeFrame: up to 7 days postpartum
measure: Rate of perinatal deaths
timeFrame: 7 dya after delivery
measure: Neonatal Apgar(Appearance, Pulse, Grimace, Activity, and Respiration) score Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed <0-3>, moderately depressed<4-6> and excellent condition<7-10>
timeFrame: Up to fifth minutes of life
Secondary outcomes:
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler Medical University
state: Kurdistan Region
Study officials:
affiliation: Hawler Medical University, college of Medicine, department of Obstetrics and Gynecology
name: Ariana K. Jawad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03184324: Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)
Official title: A Multi-Center, Randomized, Double-Blind, Active-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erosive Gastroesophageal Reflux Disease
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2017-06-12
Enrollment: 211
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of DWP14012 compared to esomeprazole in the treatment of erosive gastroesophageal reflux disease classified as Los Angeles(LA) classification grades A to D.


Eligibility criteria: Inclusion Criteria:

* Adults between 20 and 75 years old based on the date of written agreement
* Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
* Those who experienced symptoms of heartburn or acid reflux within the last 7 days

Exclusion Criteria:

* Those who have undergone gastric acid suppression or gastric, esophageal surgery
* Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease

Primary outcomes:
measure: Ratio of subjects who were completely cured of mucosal defects by 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Ratio of subjects who were completely cured of mucosal defects by 4 weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sungdong-gu
country: Korea, Republic of
facility: Hanyang University Medical Center
state: Seoul
Study officials:
References:
Clinical trial NCT05965024: Exploration on the Value of MRD Based on ctDNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer
Official title: Exploration on the Value of Molecular Residual Disease Based on Circulating Tumor DNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathological diagnosis of non-small cell lung cancer and clinical staging of stage IB-IIIB

Brief summary: Based on the unique patented MONOD and Methyl Titan methylation sequencing technology on lung cancer tissue and blood samples, a lung cancer MRD monitoring panel is designed. The panel is used to detect molecular residual disease of stage IB-IIIB non-small cell lung cancer patients underwent radical surgery, explore personalized analysis models, and conduct research on recurrence monitoring for non-small cell lung cancer patients.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old, regardless of gender;
2. Patients with pathological diagnosis of non-small cell lung cancer and clinical staging of stage IB-IIIB;
3. Able to undergo radical surgical treatment;
4. Physical condition score (ECOG) ≤1;
5. The expected survival time exceeds 24 months;
6. Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Individuals with a history of other malignant tumors within 5 years;
2. Those who have undergone neoadjuvant therapy before surgery;
3. Postoperative incision margin R1 or incision margin R2;
4. Those who have undergone a blood transfusion within 2 weeks before the surgery;
5. Individuals with systemic inflammatory response syndrome;
6. Those with serious diseases of important organs such as the heart, lungs, kidneys, and brain;
7. Participants in other clinical trials within the past 30 days and have taken investigational drugs;
8. Due to various reasons, sampling cannot be completed, samples do not meet the requirements, or baseline samples (preoperative and postoperative plasma samples, tumor tissue samples) are incomplete;
9. Researchers believe that it is not appropriate to participate in this experiment.

Primary outcomes:
measure: 2-year recurrence-free survival rate
timeFrame: Up to 24 months
Secondary outcomes:
measure: Median recurrence-free survival
timeFrame: up to 60 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00631124: A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles
Official title: A Double-blind, Randomized, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Oral Estradiol / Drospirenone Regimens in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Keywords: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigation of a new pill containing an estrogen and a progestin in order to monitor the inhibition of the ovulation in young healthy females over 3 treatment cycles


Eligibility criteria: Inclusion Criteria:

* Healthy female volunteers,
* Age 18 - 35 years

Exclusion Criteria:

* Contraindications for use of a combined (estrogen/progestogen) contraceptive (e.g. history of venous/arterial thromboembolic disease)
* Regular intake of medication
* Clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination)
* Anovulatory pre-treatment cycle

Primary outcomes:
measure: The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of ovarian activity in treatment cycles 2 and 3
timeFrame: 12 months
measure: Course of gonadotropins (FSH, LH)
timeFrame: 12 months
measure: Endometrial growth
timeFrame: 12 months
measure: Pharmacokinetics of estrogen and progestin in treatment cycle 3
timeFrame: 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05876624: The Connection Between Personality, Burnout, and Hypertension in Nigerian Bank Employees
Official title: High Stakes, High Pressure: The Connection Between Personality, Burnout, and Hypertension in Nigerian Bank Employees
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Lead sponsor: Renaissance University Ugbawka, Enugu
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all Staff of commercial banks in Nigeria

Brief summary: This is a longitudinal study which we plan to examine the link between personality traits, burnout, and hypertension in bank employees in South-eastern Nigeria

Detailed description: This proposed longitudinal study aims to examine the relationship between personality traits, burnout, and hypertension in bank employees in South-eastern Nigeria, where hypertension is a significant public health issue. The study will involve bankers as participants, who will be asked to complete self-report questionnaires and measure their blood pressure over four weeks. The research seeks to determine if personality differences and burnout levels contribute to hypertension risk in this population. By understanding the role of psychosocial factors in hypertension risk, the study hopes to provide recommendations for workplace adjustments that could improve employee well-being and reduce hypertension risk among Nigerian bank employees.

Eligibility criteria: Inclusion Criteria:

* Any staff of the Bank

Exclusion Criteria:

* Non Staff

Primary outcomes:
measure: Blood Pressure
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Enugu
country: Nigeria
facility: Renaissance University
Study officials:
affiliation: Renaissance University Ugbawka Enugu Nigeria
name: Lawrence E Ugwu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01069224: Analysis of Proinflammatory Factors in the Synovial Fluid In Patients With Rotator Cuff Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rotator Cuff Disease
Keywords: rotator cuff
synovial fluid
proinflammatory cytokines
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-02-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include a consecutive series of patients who met the study inclusion criteria. Study group patients will be diagnosed RC tear on clinical examination and imaging findings (US and MRI) that will be verified at arthroscopy in order to complete the enrollment.

Control group will include patients suffering from shoulder instability that scheduled for elective surgical repair.

Brief summary: Role of proinflammatory factors in Patients with Rotator Cuff Disease

Objective:

To measure the levels of various cytokines and metalloproteases in patients with rotator cuff disease, and control group and to determine the correlations among them.

Detailed description: We hypothesize that cytokines and MMP's level will be significantly higher in patients with RC pathology than in control group and will be related to the time frame since injury (i.e. - higher levels as close to the injury). In addition we will examine possible relation of those levels to the pain curve by using Visual Analogue Scale.

Eligibility criteria: Inclusion Criteria:

1. Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation.
2. Patients between age 18-65 scheduled for a surgery in a Shoulder unit
3. Patients suffering from Rotator Cuff Disease
4. Patients suffering from any noninflammatory shoulder condition which requires surgical intervention

Exclusion Criteria:

1. Revision rotator cuff repair
2. Recurrent shoulder surgery
3. Psychiatric illness
4. Inflammatory condition.
5. Current use of anti-inflammatory drugs.
6. Previous or current shoulder infection.

Primary outcomes:
measure: cytokines and MMP's levels in patients with RC pathology and in control group
timeFrame: 12 month
Secondary outcomes:
measure: Levels of pain curve by using Visual Analogue Scale
timeFrame: 12 month
Other outcomes:
Locations:
Study officials:
References: