louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01289093: Quality of Life After Laparoscopic Inguinal- Incisional and Umbilical Herniotomy.
Official title: Quality of Life After Laparoscopic Inguinal- Incisional- and Umbilical Herniotomy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Incisional Hernia
Umbilical Hernias
Keywords: inguinal hernia
incisional hernia
quality of life
disease-specific
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: University Hospital, Gentofte, Copenhagen
First posted: 2011-02-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care

Brief summary: LIFE-IN. Quality of life after operation for hernias are not well investigated and lack a good and easy-to-understand-tool to measure it. Carolina Comfort Scale (CCS) is a disease-specific quality of life questionnaire, designed by an American group, to monitor quality of life in patients undergoing operation for hernias.

The investigators wish to test this questionnaire against Visual Analogue Scale (VAS) scores for core-hernia symptoms, to see if the CCS is a good way to monitor the changes in quality of life and other well-known core-symptoms before and after herniotomies.

Detailed description: The investigators include consecutively all in all 140 patients. 100 with inguinal hernias; 50 who is getting a Lichtenstein operation and 50 who is getting a laparoscopic operation. Furthermore minimum 20 patients who is getting a laparoscopic operation for incisional hernia and minimum 20 who went through umbilical herniotomy. The investigators monitor their pain, sensation of mesh, movement limitations, over-all well-being, fatigue and life-quality, with both CCS and VAS questionnaires 5 times. One time preoperative and 4 times after operation, on the 1sth, 7th, 30th and 90th day after operation.

Eligibility criteria: Inclusion Criteria:

* elective laparoscopic and open operations for inguinal hernia
* elective laparoscopic operation for incisional- and umbilical hernia
* primary hernia
* uni-bilateral hernias and one or more incisional hernias

Exclusion Criteria:

* expected bad compliance to the study
* acute operations
* re-operations
* secondary operations
* primary operation with reoperation within 30 days

Primary outcomes:
measure: quality of life
timeFrame: before operation until 90 days postoperative
Secondary outcomes:
measure: acceptability
timeFrame: preoperative untill 90 days postoperative
Other outcomes:
Locations:
city: Koege
country: Denmark
facility: Koege University Hospital
Study officials:
affiliation: Zealand University Hospital
name: Thue Bisgaard, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02137993: Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia
Official title: A Multi-center, Randomized, Double Blind, Parallel, PhaseⅣ Trial to Evaluate the Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizophreniform Disorder
Schizoaffective Disorder
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
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 evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.


Eligibility criteria: Inclusion Criteria:

* 20 years to 65 years
* Schizophrenia patient with an acute exacerbation
* Understand the requirement of the study and voluntarily consent to participate in the study

Exclusion Criteria:

* Patients who have another psychiatric disorders
* Patients who have unstable medical conditions
* Patients who have clinically important abnormalities of liver function test (\>2.5 fold of upper normal limit), ECG and vital sign at screening visit
* Uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition)
* Patients who have a history of an allergic reaction to olanzapine
* Patient who have no clinical response to take two or more different atypical anti-psychotics for more than 4 weeks.
* Patient who take clozapine within 12 weeks before screening visit

Primary outcomes:
measure: Change from baseline at 6 week in total PANSS score
timeFrame: 6 week
Secondary outcomes:
measure: Change from baseline at 1, 2, 4 and 6 week in total PANSS score.
timeFrame: 6 week
measure: Responder to be decreased of 30% or more in PANSS total score from baseline at 6 week
timeFrame: 6 week
measure: Change from baseline at 6 week in total CGI-S score
timeFrame: 6 week
measure: Responder rate in CGI-I score of 'very much improved', 'much improved' and 'minimally improved'
timeFrame: 6 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05543993: COVID Booster in Pregnancy and Lactation
Official title: Serological and Functional Impact of COVID-19 Vaccination on the Maternal Fetal Unit and Infant Immunity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: vaccine
COVID-19 vaccine
booster
pregnancy
breastfeeding
immunity
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Walter Reed Army Institute of Research (WRAIR)
name: Nemours Childrens Health
First posted: 2022-09-16
Enrollment: 200
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Pregnant singleton gestation who have received bivalent COVID-19 mRNA booster in pregnancy
2. Breastfeeding individuals who have recieved bivalent COVID-19 mRNA booster

Brief summary: This is a prospective longitudinal cohort study to evaluate the impact of COVID-19 vaccination and booster on maternal and infant immunity against COVID-19 variants over time.

Detailed description: We will enroll 100 pregnant patients who have received COVID-19 mRNA booster as well as 100 breastfeeding patients who have received COVID-19 mRNA booster. Participants will be following longitudinally through 3 months post partum, or 3 months post enrollment for those in the breastfeeding cohort. Maternal blood will be collected, as will cordblood at delivery, breastmilk, and infant samples.

Eligibility criteria: Inclusion Criteria:

* Singleton gestation
* Received mRNA bivalent COVID-19 booster during 1) pregnancy or 2) breastfeeding

Exclusion Criteria:

* Multifetal gestation
* Unable to provide consent

Primary outcomes:
measure: Maternal Serological Profile
timeFrame: 3 months
measure: Maternal Functional Immunity
timeFrame: 3 months
Secondary outcomes:
measure: Infant serological profile
timeFrame: 3 months old
measure: Infant functional immunity
timeFrame: 3 months old
measure: Breastmilk serological profile
timeFrame: 3 months
measure: Infant oral immunity
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Rupsa C Boelig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02167893: Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"
Official title: Leuprorelin Acetate SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-06-19
Enrollment: 11288
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer

Brief summary: The purpose of this survey is designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate SR 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) in prostate cancer participants in daily medical practice.

Detailed description: This survey was designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate 3 months depot injection kit (Leuplin SR 11.25 mg Injection Kit) in prostate cancer participants in daily medical practice.

For adults, 11.25 mg of leuprorelin acetate is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

Eligibility criteria: Inclusion Criteria: Prostate cancer participants who meet all the following criteria:

1. Participants for whom prostate cancer was initially diagnosed on or after January 1, 2005
2. Participants with no prior history of treatment with Leuplin SR 11.25 mg Injection Kit (as an exception, participants with prior history of treatment with Leuplin 3.75 mg Injection Kit may be enrolled in the survey )
3. Participants with prostate-specific antigen (PSA) level determined at baseline or within 3 months prior to the start of treatment with Leuplin SR 11.25 mg Injection Kit

Exclusion Criteria:

-

Primary outcomes:
measure: Number of Participants Reporting One or More Adverse Drug Reactions
timeFrame: Baseline up to Week 96
measure: Number of Participants Reporting One or More Serious Adverse Drug Reactions
timeFrame: Baseline up to Week 96
Secondary outcomes:
measure: Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification
timeFrame: Baseline up to 96 weeks
measure: Percentage of Participants With Overall Survival (OS) Based on TNM Classification
timeFrame: Baseline up to 96 weeks or death (which ever occurs first)
measure: Percentage of Participants With Metastasis-free Survival
timeFrame: Baseline up to 96 weeks
measure: Percentage of Participants With Disease-specific Survival
timeFrame: Baseline up to 96 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References:
Clinical trial NCT00507793: Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus
Official title: An Open-Label Study to Evaluate the Efficacy and Safety of Cyclosporine Reduction in de Novo Renal Allograft Recipients Receiving Sirolimus: a Dose Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-27
Enrollment: 385
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: To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.

Detailed description: To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients. Cyclosporine blood levels, graft rejection rates and renal function will be assessed.

Eligibility criteria: Inclusion criteria

* At least 18 years of age
* End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor
* Patients with secondary kidney transplant must have maintained primary graft for at least 6 months

Exclusion criteria

* Antibody induction within one week of current transplantation
* Multiorgan transplants
* Patients at high-risk of rejection

Primary outcomes:
measure: A dose response model using the average cyclosporine blood levels correlated to graft rejection rates and renal function will be used to compare efficacy and safety of different doses of cyclosporine.
Secondary outcomes:
measure: Safety evaluations will include physical exams, vital signs, CBC with differential, platelet count, blood chemistries, fasting lipid profiles, BUN or urea, serum creatinine, adverse event monitoring and calculated creatinine clearance.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Muhlbacher F, Neumayer HH, del Castillo D, Stefoni S, Zygmunt AJ, Budde K; European Rapamune Cyclosporine Minimization Study Group. The efficacy and safety of cyclosporine reduction in de novo renal allograft patients receiving sirolimus and corticosteroids: results from an open-label comparative study. Transpl Int. 2014 Feb;27(2):176-86. doi: 10.1111/tri.12228. Epub 2013 Nov 25.
Clinical trial NCT02291393: The Role of High Density Surface ECG in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Official title: The Role of High Density Surface Cardiac Electrographic Mapping in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy :A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmogenic Right Ventricular Cardiomyopathy
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The diagnosis of Arrhythmogenic right ventricular cardiomyopathy can be difficult. The 80 lead ECG may increase the specificity and sensitivity in diagnosing this potentially life threatening inherited cardiac condition. This pilot would form the basis of a much larger clinical trial to test the utility of this novel diagnostic tool.


Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of arrhythmogenic right ventricular cardiomyopathy who are being followed up in the cardiology clinic

Exclusion Criteria:

* Inability to consent
* Pacing dependent patients
* Other concomitant cardiag disease e.g. coronary artery disease
* Atrial fibrillation

Primary outcomes:
measure: QRS wave dispersion in an ECG
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06463093: Differential Diagnosis of Cognitive Disorders of Psychiatric or Neurodegenerative Origin
Official title: Contribution of Brain Positon Emission Tomography With 18 Flurodeoxyglucose Labelled With Fluorine 18 for the Differential Diagnosis of Cognitive Disorders of Psychiatric or Neurodegenerative Origin
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurocognitive Disorders
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for psychiatric reasons with neurocognitive disorders in the clinic, having consulted or being hospitalized at the psychotherapeutic center of Nancy between 01/01/2021 to 01/01/2024 and having undergone a flurodeoxyglucose positron emission tomography marked with fluorine 18 carried out in the course of care

Brief summary: The aim of the research is to analyze whether 18F-FDG PET helps in the diagnosis and therefore in the management of the patient.

Detailed description: Neurocognitive disorder or Mild Cognitive Impairment corresponds to a decline in one or more cognitive functions; compared to the previous level of performance.

Indeed, the prevalence of neurodegenerative pathologies is estimated at more than one million according to Santé Publique France, due to the aging of the population. To be compared with the prevalence of the population suffering from a psychiatric disorder estimated at one in five people, or 13 million French people, in 2021.

With the increase in the prevalence of these two entities and their clinical entanglement, the question arises of the origin of neurocognitive disorders, is it a manifestation of a psychiatric pathology or a neurodegenerative pathology not yet diagnosed.

If this is the case, the patient's prognosis is modified with a pejorative evolution and a loss of autonomy which is to be anticipated. This delay deprives the patient and his family of interventions likely to alleviate behavioral disorders; maintain a level of autonomy compatible with life at home; alleviates the burden and improves the quality of life of caregivers.

Eligibility criteria: Inclusion Criteria:

* Adult patients with cognitive impairment
* Positron emission tomography with flurodeoxyglucose labeled with fluorine 18 carried out in the course of care

Exclusion Criteria:

* Patients objecting to the collection of their data

Primary outcomes:
measure: Neuro cognitive disorders and disorders of neurodegenerative origin in psychiatric population
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Nancy's hospital
Study officials:
References:
Clinical trial NCT05260593: Effect of Phonophoresis With Vitamin B12 on CTS
Official title: Effectiveness of Phonophoresis With Vitamin B12 on Patients With Mild to Moderate Carpal Tunnel Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate efficacy of phonophoresis with vitamin B12 on median nerve distal latency, pain level and hand grip strength in patients with carpal tunnel syndrome. At least Fifty four Patients from both sexes will be recruited for this study from various hospitals in 6th October city

* Group A (n = 27): will receive Phonophoresis with Vitamin B12 gel.
* Group B (n = 27): will receive placebo phonophoresis with Vitamin B12 gel.

Median nerve distal latency, hand grip strength and numerical pain rating scale will be measured at baseline and after 3 weeks.


Eligibility criteria: Inclusion Criteria:

1. at least Fifty Four patients with Mild to moderate CTS.
2. Age will range between 18 to 60 years old.
3. All patients will have Body mass index between 18.5 and 29.9 kg/m2.
4. Diagnosed by a physician according to American Association of Electrodiagnostic recent guidelines. (Jablecki et al., 2002).
5. A positive clinical provocative tests for CTS (Tinel test and Phalen test),
6. Patients with history of pain, paresthesia or numbness in the median nerve distribution, nocturnal pain, and night waking.

Exclusion Criteria:

1. Diabetic patients.
2. Hypertension patients.
3. Pregnant women
4. Cardiovascular patients
5. Patients with cervical spondylosis
6. Patients with cervical disc prolapse
7. Patients with Thoracic outlet syndrome
8. Patients with Carpal tunnel release surgery

Primary outcomes:
measure: Changes in Distal latency of median nerve sensory distal latency
timeFrame: Baseline and after 3 Weeks
measure: Changes in Distal latency of median nerve motor distal latency
timeFrame: Baseline and after 3 Weeks
Secondary outcomes:
measure: Changes in hand grip strength
timeFrame: Baseline and after 3 Weeks
measure: Changes in numeric pain rating scale (NPRS)
timeFrame: Baseline and after 3 Weeks
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: October 6 University Hospital
state: Giza
Study officials:
References:
Clinical trial NCT01851993: Inhaled Ondansetron & Dyspnea
Official title: Effects of Inhaled Ondansetron on Perceived Respiratory Discomfort (Dyspnea) During Exercise in the Presence of External Thoracic Restriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dyspnea
Keywords: Ondansetron
Exercise
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: "Dyspnea" refers to the awareness of breathing discomfort that is typically experienced during exercise in health and disease. In various participant populations, dyspnea is a predictor of disability and death; and contributes to exercise intolerance and an adverse health-related quality-of-life. It follows that alleviating dyspnea and improving exercise tolerance are among the principal goals of disease management. Nevertheless, the effective management of dyspnea and activity-limitation remains an elusive goal for many healthcare providers and current strategies aimed at reversing the underlying chronic disease are only partially successful in this regard. Thus, research aimed at identifying dyspnea-specific medications to complement existing therapies for the management of exertional symptoms is timely and clinically relevant. The purpose of this study is to test the hypothesis that single-dose inhalation of nebulized ondansetron (a serotonin 5-HT3 receptor antagonist) will improve the perception of dyspnea during strenuous exercise in health, young men. To this end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled ondansetron (8 mg) on detailed assessments of neural respiratory drive (diaphragm EMG), ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing in healthy, men aged 20-40 years.


Eligibility criteria: Inclusion Criteria:

* Male
* Aged 20-40 years
* FEV1 ≥80% predicted
* FEV1/FVC \>70%

Exclusion Criteria:

* Current or ex-smoker
* Body Mass Index \<18.5 or \>30 kg/m2
* History of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction.
* Taking doctor prescribed medications
* Allergy to latex
* Allergy to lidocaine or its "caine" derivatives

Primary outcomes:
measure: Sensory Intensity (Borg 0-10 scale) ratings of dyspnea at isotime
timeFrame: Participants will be followed until all study visits are complete, an expected average of 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University
state: Quebec
Study officials:
affiliation: McGill University
name: Dennis Jensen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: