louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02759848: The Role of Tuberculosis in Chronic Obstructive Lung Disease
Official title: The Role of Tuberculosis in Chronic Obstructive Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Role of Tuberculosis in COPD
Keywords: COPD, tuberculosis, mortality
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 598
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized with COPD exacerbation (tertiary care clinic)

Brief summary: Influence of tuberculosis (TB) on natural course of chronic obstructive lung disease (COPD) has not been well known. This study was designed to investigate the effects of history of TB on the long-term course of COPD.

Detailed description: Patients hospitalized with COPD exacerbation were consecutively included (n=598). Cases were classified into two categories: those with a history of TB and those without. Clinical, demographic, and radiological features were meticulously recorded and patients were followed up for mortality. 93 patients (15%) had past TB. On average, patients with a history of TB were four-year younger (p=0.002). Our study revealed that patients with TB history were diagnosed with COPD five-year earlier and died five-year earlier as compared to the patients without TB. In addition, in the TB history positive group, the rate of hospital admissions per year was higher compared to the group that lacked TB history (2.46±0.26 vs. 1.56±0.88; p=0.001). The patients with TB history had higher PaCO2 and lower FEV1 (p=0.008 and p=0.069 respectively). Median survival was 24 months for patients with past TB, and was 36 months for those without. Kaplan-Meier analysis revealed that although 3-year survival rate was lower in patients with TB history, it was not statistically significant (p=0.08). Cox regression analysis showed that while factors such as age, PaCO2, hematocrit, BMI and the Charlson index affected mortality rates in COPD patients (p\<0.05), prior history of TB did not seem to have a significant impact on the mortality.

Our results showed that past TB caused more hospitalizations, lower respiratory functions and higher arterial carbon dioxide levels. It was found that, though the mortality rates were similar, COPD patients with past TB was diagnosed and died five-year earlier. We conclude that history of TB has an important role in natural course of COPD.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with COPD exacerbations

Exclusion Criteria:

* Not diagnosed with COPD exacerbations

Primary outcomes:
measure: all cause mortality
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Halil Ibrahim Yakar
name: Halil I Yakar, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06827548: ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve -B
Official title: Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials Phase 2 - VNS Seizure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-Intestinal Disorder
Gastroparesis
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Purdue University
First posted: 2025-02-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if manual stimulation of the vagus nerve is possible. The vagus nerve is a largely-internal nerve that controls many bodily functions, including stomach function. The hope is that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve.

Detailed description: The purpose of this study is to find out if it is possible to gain access to the vagus nerve which is largely an internal nerve that controls stomach function. The hope is to gain access to the internal vagus nerve by electrically stimulating the nerve around the external ear. If this is possible to do this then there is hope that this will help the treatment of patients with nausea and vomiting and disordered stomach function. Healthy subjects and subjects with gastroparesis will be recruited. Subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve and also undergo blood draw before, after stimulation and later a third draw after a period of no stimulation. Healthy subjects will also undergo vagal maneuver using the Multi Array Electrodes (MEA). Subjects will also complete health history questionnaires.

Eligibility criteria: Inclusion Criteria:

* Volunteers with no GI symptoms
* Ages 18-80
* Undergoing VNS Therapy as part of clinical treatment for focal or partial epilepsy or seizure
* Willing to have MEA electrodes placed on the neck and bipolar electrodes placed on chest and stomach

Exclusion Criteria:

* Unable to provide consent
* Having gastric motility issues (not due to COVID 19) as determined by the PI or Sub I
* Taking medications affecting gastric motility
* Pregnant females
* Prisoners

Primary outcomes:
measure: Vagal Nerve Activation
timeFrame: 3 hours
measure: Measure changes in chest diameter resulting from breathing
timeFrame: 3 hours
measure: Amplitude surface electrogastrogram
timeFrame: 3 hours
measure: Heart rate variability
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hosptial
state: Indiana
Study officials:
affiliation: Professor of Clinical Medicine
name: Thomas V. Nowak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06419348: 99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer
Official title: 99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer and Compared With 68Ga-PSMA-11 PET
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Prostate Cancer Stage
PSMA
SPECT
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 99mTc-QULIC-5-P1 is a new radiotracer targeting PSMA, which is promising as an excellent imaging agent applicable to PSMA positive prostate cancer. This study will investigate the safety, biodistribution and potential usefulness of 99mTc-QULIC-5-P1 SPECT imaging for the diagnosis of lesions in PSMA positive prostate cancer.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age.
2. Signed informed consent.
3. Patients with suspected or newly diagnosed or previously prostate cancer, with PSMA positive expression (supporting evidence may include MRI, CT, and pathology report, etc).

Exclusion Criteria:

1. Patients with PSMA negative expression.
2. Patients with pregnancy.
3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
4. Known or expected hypersensitivity to 99mTc-QULIC-5-P1 or any of its components.
5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Primary outcomes:
measure: Diagnostic efficacy
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT03032848: Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients
Official title: Randomized, Blinded Trial Comparing Vaginal Estrogens on Pelvic Organ Prolapse Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaginitis Atropic
Pelvic Organ Prolapse
Endometrial Hyperplasia
Lead sponsor: Universidade Federal do Paraná
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 69
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.


Eligibility criteria: Inclusion Criteria:

* post menopause women
* normal oncotic cytology and mammogram
* any grade of pelvic organ prolapse with surgery indication and ultrasound with endometrium measure less than 5 mm

Exclusion Criteria:

* vaginal bleeding
* hormonal replacement on the past three months
* renal or hepatic desease
* porfiria
* past venous thromboembolism; ulcerated prolapse

Primary outcomes:
measure: Evaluate the histopathological effects on endometrium after each treatment
timeFrame: 48 days
measure: Compare the endometrial thickness measured by ultrassound after each treatment
timeFrame: 48 days
Secondary outcomes:
measure: Evaluate the changes of maturation index (Meisels Index) after each treatement
timeFrame: 48 days
measure: Evaluate the changes on climacteric complaints after each treatment
timeFrame: 48 days
Other outcomes:
Locations:
Study officials:
References:
citation: Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.
Clinical trial NCT06415526: OPERA - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction
Official title: Oncoplastic Entirely Robot-Assisted Approach (OPERA) - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Mastectomy; Lymphedema
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 14
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction

Brief summary: Current breast cancer surgery is achieving minimally invasive approach to reduce incision while providing better surgical vision and freedom in mastectomy. Breast reconstruction with free deep inferior epigastric artery perforator (DIEP) flap was considered the gold standard, however, the donor site morbidity remains an endless concern. Here we applied robotic-assisted surgery in both mastectomy and free DIEP flap harvest, so-called Oncoplastic Entirely Robot-Assisted Approach (OPERA).

A retrospective chart review identified 14 patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction. The patient demographics and mastectomy and flap characteristics were reviewed.


Eligibility criteria: Inclusion Criteria:

* Patients with ASA (American Society of Anesthesiologist) classification 1-2
* Breast skin should be free from cancer involvement, with adequate tumor to skin distance, and the largest preoperative tumor size no more than 5 cm
* The lesion should be located in any of the 4 quadrants away from the nipple, at least 1 cm distance between the lesion and the nipple

Exclusion Criteria:

* Patients with previous pelvis surgeries (except C-section)

Primary outcomes:
measure: ARS incision
timeFrame: Intra-operative
measure: Robotic time
timeFrame: Intra-operative
measure: Flap size
timeFrame: Intra-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT04296526: Two-phase Transteoretic Model Research for Participation in Physical Activity
Official title: Barriers to Participation in Physical Activity Among University Students: Which Intervention? Two-phase Study Using Transteoretic Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedentary Behavior
Keywords: physical activity
transtheoretical model
university students
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the first phase of this study is to determine the physical activity (PA) barriers and motivational factors of university students and their body awareness using the transteoretic model (TTM).

The aim of the second phase of the study is to evaluate the effectiveness of interventions aimed at eliminating barriers determined in students who are in the "precontemplation", "contemplation" and "preparation" stages according to TTM. Also it will be examined the effects of these interventions on PA level.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-25
* Being educated at the Faculty of Health Sciences
* Being volunteer

Exclusion Criteria:

* Being audial and vision impaired
* Having orthopedic, neurological and metabolic problems that will prevent physical activity
* Being unable to communicate in Turkish
* No pedometer program on the smartphone or using it for less than 1 year

Primary outcomes:
measure: Exercise: Stages of Change (Short Form)
timeFrame: Change from baseline at 8 weeks.
Secondary outcomes:
measure: Exercise Barrier Scale
timeFrame: At baseline and 8th weeks
measure: International Physical Activity Questionnaire - Short Form
timeFrame: At baseline and 8th weeks
measure: Motivation Scale For Participation In Physical Activity
timeFrame: At baseline and 8th weeks
measure: Body Awareness Questionnaire
timeFrame: At baseline and 8th weeks
measure: Number of steps in weekly
timeFrame: At baseline and 1-2-3-4-5-6-7-8th weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References:
Clinical trial NCT00547326: The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.
Official title: The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Otitis Media With Effusion
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2007-10-22
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Children with otitis media with effusion will be treated with osteopatic cranial techniques or with a placebo treatment. Before and after the treatment audiometric and tympanometric measures will take place. This procedure will be repeated 3 times, once a week and every session will last for 30-45 minutes. The fourth week, only audiometry and tympanomtry will be done.


Eligibility criteria: Inclusion Criteria:

* children between 3 and 7 years old
* Bilateral otitis media with effusion
* Tympanogram type B

Exclusion Criteria:

* ventilation tubes
* Damage of the tympanic membrane
* Operation of the tympanic membrane
* Other illness e.g. Down, craniofacial abnormalities,...

Primary outcomes:
measure: Audiometric and tympanometric results
timeFrame: directly after every session of treatment (3 times, once a week)
Secondary outcomes:
measure: Audiometric and tympanometric results
timeFrame: one week after the last treatment session.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: I. Dhooge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06377826: Comparison of Aerobic and Resistance Training on Exercise Capacity, Depression and Quality of Life in Hypothyroidism.
Official title: To Compare the Effects of Aerobic and Resistance Training on Exercise Capacity, Depression and Quality of Life in Hypothyroidism.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Comparison of Aerobic Exercise and Resistance Training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study will show the effects of aerobic and resistance training on exercise capacity, depression and quality of life in patients with hypothyroidism. The evaluation of TSH level before and after the exercise sessions will provide valuable data.

Detailed description: The study aims to investigate the effects of aerobic exercise and resistance training by comparing the two types of exercises, the finding of this study gain insights into the most effective approach for patients with hypothyroidism particularly in relation to exercise capacity, depression and quality of life. The study design is Randomized Controlled Trial. Sample size is calculated using G power program. the study duration is 6 months after the approval of research board. Non probability Purposive sampling is used for this study. Data will be analyzed by using SPSS version 20.

Eligibility criteria: Inclusion Criteria:

Both males and females Age between 40 to 60 years Diagnosed cases of hypothyroidism Duration: 2 years being diagnosed Patients who easily perform exercises

Exclusion Criteria:

Patients with serious comorbidities like cancer Uncontrolled hypertension Vitally unstable patients Red flags for physiotherapy

Primary outcomes:
measure: 6 Minute Walk Test
timeFrame: 8 weeks
measure: The Beck Depression Inventory Scale
timeFrame: 8 weeks
measure: SF- 36 SF-36
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottābād
country: Pakistan
facility: Abbottabad medical complex
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Riphah International University
name: saira jahan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01778257: Efficacy and Safety of Mate Extracts on Decrement of Body and Abdominal Fat in Obese Subjects
Official title: Mate Extract Supplementation Reduces Body and Abdominal Fat in Obese Korean Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Mate extracts
Obesity
abdominal fat
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
Collaborators: name: GS Engineering & Construction
First posted: 2013-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year.

Detailed description: The primary aim of the study was to investigate the effect of Mate extracts in Korean subjects on body fat and abdominal fat, double blind, placebo-controlled clinical trial.

Thirty obesity subjects with BMI ≥ 25 kg/㎡ and waist-hip ratio (WHR)≥ 0.90 for men and ≥ 0.85 for women were for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Volunteers aged 19 to 65 years
* 25 kg/m2 ≤ BMI ≥35 kg/m2
* Ability to give informed consent

Exclusion Criteria:

* Significant variation in weight (more 10%) in the past 3 month
* Cardiovascular disease, neurologic or psychiatric disease, renal, pulmonary and hepatic abnormalities
* History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease (Crohn's disease) or gastrointestinal surgery (a caesum or enterocele surgery are included)
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the sutdy
* Allergic or hypersensitive to any of the ingredients in the test products
* Pregnancy or breast feeding
* Used antipsychosis drugs therapy within past 2 months
* History of alcohol or substance abuse (21 units/week over)
* Participation in any other clinical trials within past 3 months

Primary outcomes:
measure: Changes in body and abdominal fat
timeFrame: body fat: baseline, 6 weeks and 12 weeks, abdominal fat of CT: baseline and 12 weeks
Secondary outcomes:
measure: Changes in anthropometric parameters(weight, BMI, waist and hip circumference)
timeFrame: baseline, 6 weeks and 12 weeks
measure: Changes in blood lipid profile(total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, free fatty acid)
timeFrame: baseline, 6 weeks and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Chonbuk National University Hospital
name: Min-Gul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SY, Oh MR, Kim MG, Chae HJ, Chae SW. Anti-obesity effects of Yerba Mate (Ilex Paraguariensis): a randomized, double-blind, placebo-controlled clinical trial. BMC Complement Altern Med. 2015 Sep 25;15:338. doi: 10.1186/s12906-015-0859-1.