louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00180635: NO Donors and Inhibitors to Study Imbalance of Nitrogen Stress and Antioxidant Defense in COPD
Official title: A Double Blind, Crossover Placebo-controlled Study to Evaluate the Effect of L-arginine and Aminoguanidine on Bronchial and Alveolar Nitric Oxide and Nitric Oxide Metabolites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Aminoguanidine
Nitric oxide
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to investigate the effects of oral and inhaled administration of L-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled NO and NO metabolites in exhaled breath condensate, induced sputum, nasal lavage and mouth wash fluid in healthy non-smokers, current smokers and patients with COPD.

Detailed description: Nitric oxide (NO) is produced by resident and inflammatory cells in the respiratory tract by the enzyme NO synthase (NOS), which exists in three isoforms: neuronal NOS (nNOS), inducible NOS (iNOS), and endothelial NOS. NO production is increased in patients with COPD, and the production of NO under oxidative stress conditions generates reactive nitrogen species that may amplify the inflammatory response in COPD.

Eligibility criteria: Inclusion Criteria:

* Healthy non-smokers
* Normal spirometry (FEV1 \>90 % predicted; exhaled NO bigger than or equal to 10 ppb; flow 50 ml/s)
* At risk (current smokers)

  * Normal spirometry, with or without chronic symptoms (cough, sputum production)
  * FEV1 reversibility of \<15% after inhaled beta2-agonists\*
* Moderate COPD

  * FEV1 greater than or equal to 30% and \< 80%
  * FEV1/FVC \< 70% predicted
  * FEV1 reversibility of \<15% after inhaled beta2-agonists
  * With or without chronic symptoms (cough, sputum production, dyspnea)
* Able to comprehend and grant a written informed consent

Exclusion Criteria:

* Concomitant use or pre-treatment within the last 4 weeks with oral steroids
* Respiratory infection within 4 weeks prior to entry into the trial
* Females who are pregnant or lactating
* History of current or past drug or alcohol abuse

Primary outcomes:
measure: Bronchial exhale nitric oxide (JNO)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
Study officials:
affiliation: Imperial College London
name: Sergei A Kharitonov, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brindicci C, Ito K, Torre O, Barnes PJ, Kharitonov SA. Effects of aminoguanidine, an inhibitor of inducible nitric oxide synthase, on nitric oxide production and its metabolites in healthy control subjects, healthy smokers, and COPD patients. Chest. 2009 Feb;135(2):353-367. doi: 10.1378/chest.08-0964. Epub 2008 Aug 21.
Clinical trial NCT02746835: Physical Condition and Self-efficacy in People With Fall Risk
Official title: Physical Condition and Self-efficacy in People With Fall Risk - a Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Risk
Keywords: physical condition
self-efficacy
fall risk
exercise program
Lead sponsor: Aveiro University
Sponsor class: OTHER
Collaborators: name: Centro de Saúde de Anadia
First posted: 2016-04-21
Enrollment: 7
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Middle-aged or older people with fall risk were assessed and invited to a multidisciplinary falls prevention program. This program consisted on an adapted exercise program.

Two sessions per week were performed, during 6 weeks supervised by a physiotherapist.

At the end of this program, measures of physical condition and of self-efficacy were repeated to determine its related-effect.


Eligibility criteria: Inclusion Criteria:

* Fall Risk (Morse scale)

Exclusion Criteria:

* Had no capacity to walk independently

Primary outcomes:
measure: Self-efficacy moving indoors
timeFrame: 6-weeks
measure: Self-efficacy moving outside
timeFrame: 6-weeks
measure: Self-efficacy walking uneven surfaces
timeFrame: 6-weeks
measure: Self-efficacy in physical activities
timeFrame: 6-weeks
Secondary outcomes:
Other outcomes:
measure: Physical Condition related with mobility
timeFrame: 6-weeks
measure: Physical Condition related with balance
timeFrame: 6-weeks
measure: Physical Condition related with endurance
timeFrame: 6-weeks
Locations:
city: Anadia
country: Portugal
facility: Marlene Cristina Neves Rosa
state: Aveiro
Study officials:
References:
Clinical trial NCT06960135: Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy
Official title: Predictors of Trifecta Achievement in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trifecta Achievement
Pentafecta Achievement
Keywords: Laparoscopic, Partial Nephrectomy
Trifecta, Pentafecta Achievement
Renal Tumors
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Partial nephrectomy (PN) is a reference standard for the management of the cT1 renal mass, primarily due to better preservation of renal function. The aim of this work was to determine trifecta outcomes of open PN (OPN) and laparoscopic PN (LPN) and identify predictive factors for trifecta achievement to evaluate surgical performance, including negative surgical margins, absence of severe surgical complications, and ischemia time less than 25 minutes.

Objectives: this study pointing to determine trifecta outcomes of OPN and LPN and to identify predictive factors for trifecta achievement to evaluate surgical performance, including negative surgical margins, absence of severe surgical complications, and Ischemia time less than 25 Minutes.

Detailed description: Methods: This prospective, randomized study was carried out on 35 patients with clinical T1 N0M0 renal tumors. Patients were divided into two groups: Group A (n=38): underwent OPN and group B (n=32): underwent LPN.

Eligibility criteria: Inclusion Criteria:

* • Patients who are fit for surgery.

  * Patients with renal tumor who are indicated for partial nephrectomy

Absolute:

1. Solitary kidney.
2. Bilateral renal tumor.
3. CDK.

Relative:

1. Abnormal contralateral kidney (nephropathy, nephrolithiasis, trauma).
2. Metabolic disease associated with renal failure (DM, hypertension).
3. Genetic syndrome with tumor multifocality (VHL syndrome). Elective

1. Clinical T1N0M0 Tumor. 2. Peripheral tumor.

Exclusion Criteria:

* • Patients who are unfit for surgery and who's unfit for laparoscopy.

  * Patients who are contraindicated for partial nephrectomy. As severe and irreversible coagulopathy. Patients who are indicated for radical nephrectomy (extensive tumor, metastatic tumor).

Primary outcomes:
measure: Predictors of Trifecta Achievement in Open ald Laparoscopic Partial Nephrectomy for Localised Renal Tumors
timeFrame: 2 years
Secondary outcomes:
measure: Pentafecta Achivement
timeFrame: 2 yrs
Other outcomes:
Locations:
city: Qena, Egypt
country: Egypt
facility: SVU hospital
state: Qena
Study officials:
References:
Clinical trial NCT02986035: Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis
Official title: Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcifying Shoulder Tendinitis
Lead sponsor: Consorci Sanitari del Maresme
Sponsor class: OTHER
Collaborators: name: PRODUCTOS SANITARIOS ECA-RVB SLI
First posted: 2016-12-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot trail aims to assess the effectiveness of ECA cream in the treatment of calcifying shoulder tendinitis in terms of:

1. Reduction or removal of shoulder calcifications
2. Functional improvements
3. Pain improvements 10 subjects will be assessed prior and 1 and 2 months post intervention onset. The intervention will consist in the application of the ECA cream in the affected shoulder twice a day during 1 month.


Eligibility criteria: Inclusion Criteria:

* patients \>=18 years
* diagnosed of calcifying shoulder tendinitis diagnosed by a medical specialist (rehabilitation, orthopedic surgeon or rheumatologist) by x-ray
* with disease evolution of more than 3 months and less than 12 months
* that give their informed consent by writing

Exclusion Criteria:

* Previous shoulder surgery patients
* Patients with shoulder affections treated with shockwaves or corticosteroid injections.

Primary outcomes:
measure: Presence of shoulder calcifications
timeFrame: 2 months
measure: Size of shoulder calcifications
timeFrame: 2 months
Secondary outcomes:
measure: Shoulder functionality
timeFrame: 1 and 2 months
measure: Shoulder pain
timeFrame: 1 and 2 months
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Consorci Sanitari del Maresme
state: Barcelona
Study officials:
References:
Clinical trial NCT05549635: Database and Biobank of Patients With Hypersensitivity Pneumonitis
Official title: Pulmonary Fibrosis Biobank - Hypersensitivity Pneumonitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypersensitivity Pneumonitis
Keywords: biomarker
prognosis
diagnosis
phenotyping
genotyping
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with an MDT-diagnosis of HP are eligible.

Brief summary: Sub-study of the main Pulmonary Fibrosis Biomarker (PFBIO) cohort (NCT02755441), recruiting patients with an MDT-diagnosis of hypersensitivity pneumonitis (HP). Patients are included for the collection of blood samples and regular clinical data.

The database and biobank will be available for studies of HP, and can be directly compared to the main PFBIO cohort, which has recruited patients with Idiopathic pulmonary Fibrosis (IPF) since 2016.

Biomarkers will be assessed as diagnostic and prognostic. Further subtyping of HP, based on blood markers (including precipitins) will also be possible with the PFBIO-HP project.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of HP at an MDT conference according to the current international guidelines
* Age of 18 years or older
* The patients must be capable of giving informed consent

Exclusion Criteria:

- Unable to sign informed consent

Primary outcomes:
measure: Diagnosis of HP
timeFrame: 0 days
measure: Exposure to inciting antigen (patient reported)
timeFrame: 0 days
measure: Exposure to inciting antigen (measurable)
timeFrame: 0 days
measure: Progression free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Quality of life questionnaires
timeFrame: 3 years
measure: Pulmonary function test
timeFrame: 3 years
measure: Pulmonary function test
timeFrame: 3 years
measure: Imaging
timeFrame: 3 years
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Department of respiratory medicine
state: Copenhagen
Study officials:
References:
Clinical trial NCT00959335: Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions
Official title: Randomized, Open-Label, 1-Way Parallel, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex (Reference) Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Hirsutism
Keywords: treatment
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Anapharm
name: Richard Larouche, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03624335: Influence of Umbilical Cord Clamping Time in the Newborn
Official title: Influence of Umbilical Cord Clamping Time in the Newborn, Secondary Neonatal Morbidity and Iron Deposits in the Neonate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia Neonatal
Polycythemia Secondary
Hyperbilirubinemia, Neonatal
Keywords: Umbilical cord clamping
Anemia Neonatal
Iron metabolism disorders
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
Collaborators: name: Hospital Universitario de la Plana
name: FUNDACIÓN DAVALOS FLETCHER
First posted: 2018-08-10
Enrollment: 195
Sex: ALL
Minimum age (years): 35
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trials comparing early and late cord clamping
Primary purpose: OTHER

Brief summary: This study compares two umbilical cord clamping times; the early one, up to a minute (ECC) and the late or delayed one, when the cord stop beating (DCC). The additional blood volume delivered to the newborn from the placenta - placental transference - by delaying umbilical cord ligation, increases the contribution of neonatal iron with increased iron stores in the infant, without increasing neonatal morbidity.

Detailed description: It is an intervention study without drugs administration with a longitudinal, prospective comparison and correlational design.

Patients are recruited by simple random sampling to one of the two intervention groups:

Group 1-ECC: Early clamping of the umbilical cord (before the first minute of life).

Group 2-DCC: Delayed clamping of the umbilical cord (when it stops beating).

Eligibility criteria: Inclusion Criteria:

- neonates with a gestational age of 35 to 42 weeks and born through normal vaginal delivery.

Exclusion Criteria:

* monochorionic multiples
* incarcerated mothers
* placenta previa
* concern for abruptions
* Rh sensitization
* hydrops
* congenital anomalies
* the obstetrician declining to perform the intervention

Primary outcomes:
measure: haemoglobin
timeFrame: 6hours
measure: haemoglobin
timeFrame: 28 days
measure: haematocrit
timeFrame: 6 hours
measure: haematocrit
timeFrame: 28 days
Secondary outcomes:
measure: serum ferritin
timeFrame: 6hours
measure: serum ferritin
timeFrame: 28days
measure: bilirubin
timeFrame: 6hours
measure: bilirubin
timeFrame: 28days
Other outcomes:
Locations:
city: Villarreal
country: Spain
facility: Hospital Universitario de La Plana
state: Castellón
Study officials:
affiliation: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
name: Vanesa Rodenas, PhD
role: STUDY_CHAIR
References:
citation: Orenga-Orenga BJ, Gregori-Roig P, Real-Fernandez A, Donat-Colomer F, Sanchez-Thevenet P. Umbilical cord clamping time and maternal satisfaction. Midwifery. 2022 Dec;115:103487. doi: 10.1016/j.midw.2022.103487. Epub 2022 Sep 13.
Clinical trial NCT05193435: Comparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
Official title: Comparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to compare the effects of stabilization exercises and pelvic floor muscle training in women with stress urinary incontinence.

Detailed description: Stress urinary incontinence is involuntary urinary incontinence with increased intraabdominal pressure. Different exercise approaches such as pelvic floor exercises and stabilization exercises are used in these patients. There is a need for studies comparing the effects of these exercises.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 18-65 who have symptoms of stress or stress-dominant mixed urinary incontinence, who volunteered to participate in the study

Exclusion Criteria:

* Those who are pregnant, have communication and cooperation problems, have a concomitant neurological or rheumatological disease, have a history of surgery involving the abdominal and pelvic regions in the last year, have undergone spine surgery, those diagnosed with pure urge urinary incontinence or mixed type incontinence, those with advanced pelvic organ prolapse, those with a spinal deformity (such as scoliosis), the presence of orthopedic problems in the lower extremities (such as lower extremity shortness, presence of deformity etc.) and vestibular system disorder

Primary outcomes:
measure: Urinary incontinence severity
timeFrame: change from baseline at 8 weeks
Secondary outcomes:
measure: Urinary symptoms
timeFrame: change from baseline at 8 weeks
measure: Life quality
timeFrame: change from baseline at 8 weeks
measure: Pelvic floor muscle activation response
timeFrame: change from baseline at 8 weeks
measure: Pelvic floor muscle strength
timeFrame: change from baseline at 8 weeks
measure: Core stability
timeFrame: change from baseline at 8 weeks
measure: Balance
timeFrame: change from baseline at 8 weeks
measure: Spinal function
timeFrame: change from baseline at 8 weeks
measure: Subjective perception of improvement
timeFrame: After treatment (at 8 week)
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05940935: The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations
Official title: The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations; Does Topiramat or Zonisamide Cause Metabolic Acidosis?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Acidosis
Antiepileptic Drugs
Craniotomy
Anesthesia Management
Keywords: Antiepileptic Drugs
Metabolic Acidosis
Anesthesia Management
Craniotomy
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent craniotomy and intracranial surgery at Trakya University Medical Faculty Hospital and used antiepileptic drugs were included in the study as a retrospective file review. The files of 35 patients who met the study criteria were reviewed retrospectively.

Brief summary: The relationship of developing metabolic acidosis with antiepleptic drugs in craniotomy operations

Detailed description: Metabolic acidosis is a life-threatening complication in the perioperative, intraoperative and postoperative period. It can cause decreased cardiac output, electrolyte imbalance, surgical bleeding and neurological complications, even coma and death in surgical patients.

Topiramate and zonisamide are sulfonamide derivative compounds used in the treatment of epilepsy. It has been shown in studies that both drugs have a strong inhibition of carbonic anhydrase enzyme. Recent case reports suggest that both drugs may cause metabolic acidosis by lowering serum bicarbonate levels in some patients.

Aim in this study is to determine the relationship between preoperative, intraoperative and postoperative metabolic acidosis and to emphasize the importance of anesthesia management in patients who have undergone craniotomy and use antiepileptic drugs.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing intracranial surgery with craniotomy and using antiepileptic drugs
* ASA I-III
* Patients undergoing elective surgery

Exclusion Criteria:

* Patients with a surgical procedure time of more than 5 hours
* Patients who received more than 2 units of blood transfusion during the operation
* Patients taking other drugs that can cause metabolic acidosis
* Patients with diabetes mellitus, diabetes insipidus, hepatic or renal disease

Primary outcomes:
measure: Preoperative Metabolic Acidosis
timeFrame: Baseline
measure: Intraoperative Metabolic Acidosis
timeFrame: during the operation
measure: Postoperative Metabolic Acidosis
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
state: Centrum
Study officials:
affiliation: Trakya University
name: SEVTAP HEKİMOĞLU ŞAHİN, Professor
role: PRINCIPAL_INVESTIGATOR
References: