louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01357460: Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
Official title: Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hereditary Emphysema (Alpha 1-antitrypsin Deficiency)
Keywords: Emphysema
alpha1 antitrypsin deficiency
endoscopic lung volume reduction
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-05-20
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency might benefit from endoscopic implantation of intrabronchial valves.

Detailed description: Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 25 patients with advanced heterogeneous emphysema due to alpha1 antitrypsin deficiency. All patients will undergo treatment at one study centre in Heidelberg. Therapy of all patients consists of implantation of intrabronchial valves (IBV, Spiration, Olympus) in the most emphysematous destroyed lobe.

Eligibility criteria: Inclusion Criteria:

* pulmonary function: FEV1 \< 45 %, RV \> 150 %, TLC \> 100 %
* alpha1 antitrypsin deficiency (\< 80 mg/dl), genotype: PiZS, PiZZ, Pi0/0
* heterogenous emphysema

Exclusion Criteria:

* homogenous emphysema
* significant bronchiectasis
* severe concomitant diseases
* pregnancy

Primary outcomes:
measure: Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity)
timeFrame: 3 months
Secondary outcomes:
measure: Number of major complications
timeFrame: 3 months
measure: Evaluation of IBV migration rate
timeFrame: 3 months
measure: Average changes in pulmonary function (FEV1, VC (vital capacity), RV, TLC, RV/TLC)
timeFrame: 3 months
measure: Average changes in 6-minute-walk-distance
timeFrame: 3 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik
Study officials:
affiliation: Heidelberg University
name: Daniela Gompelmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02320760: Physical Activity on Prescription in Overweight Older Adults
Official title: Physical Activity in Prevention and Treatment of Overweight, Central Obesity and the Metabolic Syndrome - a Randomised Controlled Study in Overweight 65 Year Old Women and Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Physical Activity Level
Central Obesity
Metabolic Syndrome
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 102
Sex: ALL
Minimum age (years): 65
Maximum age (years): 69
Standard ages: OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized controlled study evaluates the effect of individualized physical activity on prescription (PAP) in older overweight adults. The primary hypothesis is that an individualized prescription of physical activity increases physical activity level in overweight older adults after 6 months. Secondary hypothesis are that the increased physical activity level will improve cardio metabolic risk factors and quality of life.

200 women and men, aged 65 with low physical activity level, overweight, and abdominal obesity, will be randomized to an intervention group or a control group. The control group receives general information about physical activity and registration of physical activity level for one week. The intervention group receives in addition an individualized physical activity on prescription with patient-centered counseling.

After six months both groups go through the same health check-up as at baseline and follow-ups take place after 12 and 24 months.


Eligibility criteria: Inclusion Criteria:

* BMI between 25 and 40
* waist circumference over 88 cm for women and 102 cm for men
* basically healthy
* mostly sedentary in their leisure time

Exclusion Criteria:

* current heart disease
* tablet or insulin treated diabetes type 2
* cancer
* other chronic serious illness

Primary outcomes:
measure: physical activity level
timeFrame: 6 months
Secondary outcomes:
measure: cardiometabolic risk factors
timeFrame: 6 months
Other outcomes:
measure: Quality of life
timeFrame: 6 months
Locations:
Study officials:
References:
citation: Olsson SJ, Borjesson M, Ekblom-Bak E, Hemmingsson E, Hellenius ML, Kallings LV. Effects of the Swedish physical activity on prescription model on health-related quality of life in overweight older adults: a randomised controlled trial. BMC Public Health. 2015 Jul 21;15:687. doi: 10.1186/s12889-015-2036-3.
Clinical trial NCT01854060: Predictive Factors for a Clinical Diagnosis of Irritable Bowel Syndrome in a Large Cohort of Young Adults.
Official title: Predictive Factors for a Clinical Diagnosis of Irritable Bowel Syndrome in a Large Cohort of 440,822 Young Adults.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
Epidimiology
Deterioration in the severity of irritable bowel syndrome
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 440822
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of Israeli men and women aged 18-39 years who served in active military service (mandatory and career service) between the years 2005-2011

Brief summary: The prevalence of IBS in the community has been reported in numerous cross-sectional surveys. However, less is known about the incidence of IBS ,mainly due to its slow development and to patients under-reporting. Furthermore, only one study has analyzed data concerning potential risk factors for the diagnosis of IBS. The investigators will examine the incidence of IBS in a large cohort of young adults and will look at the association of socioeconomic, anthropometric and occupational factors with IBS incidence.


Eligibility criteria: Inclusion Criteria:

* All Israeli men and women
* aged 18-39 years
* served in active military service (mandatory and career service) between the years 2005-2011

Exclusion Criteria:

* Diagnosis of celiac disease
* Inflammatory bowel disease
* Cancer in the digestive system

Primary outcomes:
measure: Incidence of clinical diagnosis of irritable bowel syndrome
timeFrame: 6 years
Secondary outcomes:
measure: predictive factors for the clinical diagnosis of irritable bowel syndrome
timeFrame: 6 years
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Israel Defence Forces, Medical Corps
Study officials:
References:
Clinical trial NCT04563260: Effect of Palonosetron on Remifentanil for Preventing Emergence Cough in Female
Official title: Effect of Palonosetron on Effect-site Concentration of Remifentanil for Preventing Emergence Cough During General Anesthesia in Female Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder Diseases
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 45
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in female patients who receive the palonosetron or not.

Detailed description: Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

Eligibility criteria: Inclusion Criteria:

* Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* BMI \> 30 kg/m2, respiratory infection, uncontrolled hypertension

Primary outcomes:
measure: optimal Ce of remifentanil
timeFrame: From the end of surgery until the time of endotracheal extubation, about 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Study officials:
References:
Clinical trial NCT03069560: Short Message System (SMS) for Caregivers of Suicidal Patients to Prevent Recidivism of Suicide Attempts
Official title: Short Message System (SMS) for Caregivers of Suicidal Patients to Prevent Recidivism of Suicide Attempts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of the Suicide
Keywords: suicide attempt
SMS monitoring
Phone
Prevention control
tertiary healthcare
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Assessment of the feasibility of a monitoring device by SMS in which messages are sent by the caregiver after a suicidal act.


Eligibility criteria: Inclusion Criteria:

* Male or female, over 18 years of age and hospitalized;
* Survivor of a suicide attempt;
* Giving informed, dated and signed consent;
* Can be reached by mobile phone. The study is proposed to all adult suicides and to the patient's designated caregiver, meeting the inclusion criteria.

Exclusion Criteria:

* Patient whose clinical condition is incompatible with the formulation of his non-opposition.
* The patient and his / her caregiver shall not be afforded a protective justice measure.

Primary outcomes:
measure: Measurement of the feasibility of the device by the patient according to a validated questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: The questionnaire measuring the feasibility for the caregiver of such a device
timeFrame: 6 months
measure: Questionnaires on the acceptability of patients and caregivers in relation to the use of this type of monitoring device
timeFrame: 6 months
measure: Qualitative analysis of messages sent to patients during the study.
timeFrame: 6 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References:
Clinical trial NCT00284960: The Incidence and Treatment of Insulin Resistance Among Men With Erectile Dysfunction
Official title: The Incidence and Treatment of Insulin Resistance Among Men With Erectile Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Metabolic Syndrome
Insulin Resistance
Keywords: erectile dysfunction
metabolic syndrome
insulin resistance
etiology
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2006-02-01
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Determine if men with erectile dysfunction (ED) are more likely to have insulin resistance compared to healthy controls.

Detailed description: Insulin is a hormone produced by the body that lets sugar into the cells, where it is used for energy. Insulin resistance occurs when the body's cells have a decreased ability to react to insulin. This leads to an increase in insulin secretion. Over time, insulin resistance can lead to higher levels of sugar in the blood (diabetes), and can also contribute to obesity, high blood pressure, high cholesterol levels and heart disease. There are no simple tests to actually diagnose insulin resistance. Currently, the glucose tolerance test is used to diagnose IR, but it involves several blood draws over a 2-hour period. Another purpose of this study is to compare a blood test involving only one blood draw to the 2-hour glucose tolerance test, which involves several blood draws over a 2-hour period.

It is well known that diabetes often leads to erectile dysfunction. Because insulin resistance occurs before diabetes, it is possible that erectile dysfunction may occur in some individuals while they have insulin resistance, but before they develop diabetes. If this is true, it might be possible to use erectile dysfunction as a sign of insulin resistance, which may lead to more timely treatment of insulin resistance and may delay or prevent the development of diabetes, and the other problems mentioned above.

Eligibility criteria: Inclusion Criteria:

* 18-65 years of age, male,

Exclusion Criteria:

* diabetes, peyronies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Hershey Med Center
state: Pennsylvania
Study officials:
name: J C Trussell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05634460: Comparison of 5% Potassium Hydroxide With 10% Potassium Hydroxide Solution in Treatment of Molluscum Contagiosum
Official title: Comparison of 5% Potassium Hydroxide With 10% Potassium Hydroxide Solution in Treatment of Molluscum Contagiosum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Molluscum Contagiosum
Keywords: potassium hydroxide 5% and 10% lotion
Lead sponsor: Combined Military Hospital Abbottabad
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Molluscum is a virus-related skin infestation which is commonly seen among children. Molluscipox virus, the largest human virus, causes it. MC typically manifests as a single or multiple dome-shaped, shiny, pearly white papules with a central dimple. In immunocompetent individuals, spontaneous resolution usually occurs within 18 months; however, the lesion may persist for several years. Asymptomatic lesions are common. It is also linked to a high risk of transmission and an increasing prevalence in global populations1-2.

Patients may receive therapy for social and cosmetic reasons, and also to avoid spreading disease to others. Numerous modalities are currently available, including Potassium hydroxide, curettage, cryotherapy, disinfected needle pricking, photodynamic therapy, laser, salicylic acid, glycolic acid etc3-4.

Potassium hydroxide (KOH) is a topical treatment for Molluscum contagiosum. Dermatologists routinely use potassium hydroxide (KOH) in varying concentrations to identify fungal elements. Because it is a strong alkali with keratolytic characteristics, variable concentrations given for management of MC. Because it is inexpensive and widely accessible, it has the potential to be a useful method for treating for MC in resource-constrained countries5-6.

The purpose of this study is to examine two varied concentrations of Potassium hydroxide (5%-KOH vs 10%-KOH) among MC patients in order to determine the most effective KOH concentration to manage Molluscum Contagiosum among children.


Eligibility criteria: Inclusion Criteria \<100 lesions no therapy within the earlier one month

Exclusion Criteria:

known hypersensitivity and immunodeficiency

Primary outcomes:
measure: . Efficacy was classified as follows: • complete remission (≥ 90% clearance of lesions) • partial remission (60-90% clearance of lesions) • insignificant improvement (<60% clearance of lesions)
timeFrame: 06 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: CMH
state: KPK
Study officials:
affiliation: Combined Military Hospital Abbottabad
name: Bushra Muzaffar, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04685460: 3D Printed Bolus in Post-mastectomy Radiotherapy
Official title: Clinical Study of 3D Printed Bolus for Volumetric Modulated Arc Therapy of Post-mastectomy Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Radiotherapy Side Effect
Lead sponsor: Jiangxi Provincial Cancer Hospital
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, there is growing interest in the application of three-dimensional (3D) printed bolus to radiotherapy.At present, the researches on the application of 3D-printed bolus in breast cancer are mainly focused on air gap between skin and bolus or electron beam conformal therapy \[7,15\], there are no clinical experience with customized 3D-printed bolus for volumetric modulated arc therapy (VMAT) in daily practice has been published up to now. We aim to evaluate dosimetry and application of 3D-printed bolus for the post-mastectomy radiotherapy (PMRT) with Volumetric modulated arc therapy (VMAT). Seventy five patients with breast cancer receiving radiotherapy following post-mastectomy in our department were randomly selected in this study. The accuracy of fit of the 3D-Printed bolus to the chest wall was improved significantly relative to conventional bolus.This study demonstrates customized 3D-printed bolus in post-mastectomy radiation therapy improves fit of the bolus compared to conventional bolus. Furthermore, VMAT based on 3D-printed bolus significantly improves the chest wall target coverage and the conformity of plan, and reduces the dose of ipsilateral lung and heart, compared to conventional bolus.


Eligibility criteria: Inclusion Criteria:

* breast cancer patients with post-mastectomy treatment

Exclusion Criteria:

* NA

Primary outcomes:
measure: dose comparison
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital of Nanchang University
state: Jiangxi
Study officials:
References:
Clinical trial NCT00175760: Can a Very High Result From a Screening Test for Celiac Disease be Used to Diagnose Celiac Disease?
Official title: Prospective Assessment of High Titre TTG to Diagnose Celiac Disease in Select Paediatric Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Keywords: TTG
pediatric
comparison study
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Aged 2 months to 18 years with a planned upper GI endoscopy.

Brief summary: This study is to see if a high response to the TTG screening test for celiac disease is as accurate as the current method of diagnosing celiac disease which entails a general anesthetic and upper endoscopy to obtain biopsies of the small intestine. If the screening blood test is highly accurate, then some patients that are being evaluated for celiac disease may not require an upper GI endoscopy and can be treated more quickly. If they respond to the therapy then they will be deemed to have celiac disease.

Detailed description: All patients scheduled for upper GI endoscopy will be approached for recruitment into the study. A minimum of 4 small intestinal biopsies will be taken from all subjects and controls. All TTG specimens will be run through the hospital laboratory. Intermediate level TTG values 20-100 will be assessed separately and as part of the larger group. An optional part B of the study will assess the frequency of lactose intolerance in subjects prior to the start of a gluten free diet.

Eligibility criteria: Inclusion Criteria:

Inclusion-All patients planned to undergo upper GI endoscopy with biopsies.

Exclusion Criteria:

Exclusion-refusal to participate, not planning to have biopsies performed with the endoscopy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Dr. Collin Barker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02914860: Comparison of the Ganglionated Plexi Activity in Patients With Different Forms of Atrial Fibrillation Guided by SUMO Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
Collaborators: name: Spectrum Dynamics
First posted: 2016-09-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare DUA (discrete uptake accumulations) of mIBG activity in patients with different forms of atrial fibrillation and within a sub-group of healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients, age ≥ 18 and ≤ 80 years.
2. Male or female, age ≥ 50 years in the healthy volunteers group
3. No heart pathology (for volunteers)
4. PAF, Pers AF and L-s Pers AF (ECG documented).
5. LVEF ≥ 50%
6. Able to provide written informed consent
7. Able to comply with the requirements of the study

Exclusion Criteria:

1. Previous AF ablation therapy
2. Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
3. Recent (3 months) myocardial infarction (MI), stroke or transient ischemic attack (except if the patient had a DES implanted stent post-MI it would be one year)
4. Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol
5. Use of medication for non-cardiac medical conditions that is known to interfere with 123I-mIBG uptake and cannot be safely withheld for at least 24 hours prior to the D-SPECT study procedures

Primary outcomes:
measure: location of discrete uptake accumulations
timeFrame: 1 week
Secondary outcomes:
measure: adverse events
timeFrame: 1 week
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Study officials:
References: