louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06476769: Combined Effects of Blow Bottle Device and Postural Drainage in Moderate to Severe Elderly COPD Patients
Official title: Combined Effects of Blow Bottle Device and Postural Drainage in Moderate to Severe Elderly COPD Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Dyspnea
Postural drainage
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It will be a randomized clinical trial. Age of selected subjects will be between 40 to 70 years. Data will be collected from Wazirabad institute of cardiology. There will be 2 groups i.e. group A will receive combination of blow bottle technique and postural drainage and group B will receive postural drainage. Spirometer will be used to evaluate pulmonary functions and breathless, cough and sputum scale (BCSS) will be used to evaluate the improvement in sputum diary of patients. Interventions will be given to the patients for 20-25 minutes twice a day for 6 days per week. After data collection, data will be analyzed using SPSS version 25.


Eligibility criteria: Inclusion Criteria:

* Diagnosed moderate to severe GOLD (2017) COPD
* 40-60 years old
* Both male and female
* Patients hemodynamically stable
* PFT showing irreversible airflow limitation.

Exclusion Criteria:

* Type II diabetic mellitus
* Systemic illness
* Thoracic deformation or rib fracture.
* Pulmonale decompensation and signs of an unstable heart condition.

Primary outcomes:
measure: Breathlessness cough sputum scale
timeFrame: 4 weeks
measure: Modified borg RPE scale:
timeFrame: 4 weeks
measure: Incentive spirometry
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Multān
country: Pakistan
facility: Wazirabad Institute of Cardiology
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sidra Faisal, MS.CPPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kullowatz A, Kanniess F, Dahme B, Magnussen H, Ritz T. Association of depression and anxiety with health care use and quality of life in asthma patients. Respir Med. 2007 Mar;101(3):638-44. doi: 10.1016/j.rmed.2006.06.002. Epub 2006 Aug 7.
citation: Goodwin RD, Eaton WW. Asthma and the risk of panic attacks among adults in the community. Psychol Med. 2003 Jul;33(5):879-85. doi: 10.1017/s0033291703007633.
citation: Wright RJ, Rodriguez M, Cohen S. Review of psychosocial stress and asthma: an integrated biopsychosocial approach. Thorax. 1998 Dec;53(12):1066-74. doi: 10.1136/thx.53.12.1066.
Clinical trial NCT00845169: The Role of Nitric Oxide Synthase Isoforms in the Cardiovascular Effects of Air Pollution
Official title: The Role of Nitric Oxide Synthase Isoforms in the Cardiovascular Effects of Air Pollution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Keywords: Air Pollution
Nitric Oxide
Nitric Oxide Synthase
Diesel exhaust
endothelial dysfunction
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
name: Umeå University
First posted: 2009-02-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Exposure to air pollution has been linked to increased cardiorespiratory morbidity and mortality. The exact component of air pollution that mediates this effect is unknown, but the link is strongest for fine combustion derived particulate matter derived from traffic sources. Recently, it has been demonstrated that inhalation of diesel exhaust impairs vascular vasomotor tone and endogenous fibrinolysis. The mechanism underlying these detrimental vascular is unclear, but is thought to be via oxidative stress and altered bioavailability of endogenous nitric oxide. In these studies we plan to elucidate the role of endogenous nitric oxide synthase isoforms (NO) in the adverse vascular responses observed following exposure to diesel exhaust.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Regular medication use (except oral contraceptive pill)
* Current smokers
* Significant occupational exposure to air pollution
* Intercurrent illness

Primary outcomes:
measure: Forearm blood flow measured by venous occlusion plethysmography during intraarterial infusion of nitric oxide synthase inhibitors L-NMMA, SMTC and 1400W and positive control norepinephrine.
timeFrame: 2-4 hours after exposure
Secondary outcomes:
measure: Plasma nitrite concentration
timeFrame: During forearm study
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
Study officials:
affiliation: Umeå University
name: Anders Blomberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh
name: David E Newby, PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03395769: Individual Patient Expanded Access for AB-SA01, an Investigational Anti-Staphylococcus Aureus Bacteriophage Therapeutic
Official title: Expanded Access Program for AB-SA01, an Investigational Anti-Staphylococcus Aureus Bacteriophage Therapeutic, for the Treatment of Serious Infections Caused by Staphylococcus Aureus.
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: Armata Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-10
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of the expanded access program is to allow physicians to provide treatment with investigational drug, AB-SA01, for patients with serious or immediately life-threatening Staphylococcus aureus infections, for which no alternative treatment(s) are currently available, and who meet the criteria for treatment under FDA's Expanded Access regulations and criteria set forth by AmpliPhi Biosciences Corporation.

To be considered for expanded access, the request should be submitted to AmpliPhi by a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational medicine. Treating physicians should contact AmpliPhi by emailing expandedaccess@ampliphibio.com with "Expanded Access Request" in the subject line, and include in the email the treating physicians name, organization/hospital/institution, physical address, email address, telephone number, and a brief description of the indication/condition.

Any approval of expanded access to investigational medicine must always comply with the applicable laws and regulations.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05536869: Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean (FAUCS)
Official title: Prospective Multicenter Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section; Dehiscence
Extra Peritoneal Caesarean Section
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2022-09-13
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective of this study is to compare the time taken to obtain "street fitness" status for women after extraperitoneal cesarean section compared to women after a classic cesarean section.


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for a caesarean between 38 and 42 weeks pregnant
* Patient aged between 18 and 42 years old
* Singleton
* Caesarean section with a theoretical operating time \< 1 hour (without major complications)
* Patient affiliated to a social security scheme
* Patient having signed the free and informed consent.

Exclusion Criteria:

* BMI \> 40
* High blood pressure treated intravenously
* Pre-existing diabetes in pregnancy
* Allergy to analgesics
* Prenatal depression
* Pathological insertion of the placenta (placenta previa or accreta).
* History of major pelvic or abdominal surgery (myomectomy, peritonitis) other than caesarean section or minor surgery.
* Addiction (drugs)
* Pre-existing psychiatric pathology leading to a risk of impaired judgment or behavior.
* Patient participating in another clinical study with a drug or medical device
* Protected patient: Adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Patient hospitalized without consent.

Primary outcomes:
measure: The postoperative time in hours from which the patient stably fulfills the criteria for "street fitness".
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Versailles
country: France
facility: Les Franciscaines Clinic
state: IDF
Study officials:
References:
Clinical trial NCT04326569: Copeptin in the Diagnosis of Post-operative Insipidus Diabetes After Pituitary Surgery
Official title: Interest of the Copeptine Dosage in Diagnosis of Post-operative Insipidus Diabetes After Transsphenoidal Pituitary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pituitary Surgery
Keywords: Pituitary surgery
post-operative insipidus diabetes
copeptin
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Endoscopic trans-sphenoidal pituitary endoscopic surgery is one of the main axes of management of tumours of the sellar region.

Central diabetes insipidus is a frequent complication of endoscopic trans-sphenoidal pituitary endoscopic surgery, with a prevalence of up to 30% of cases. It is the consequence of insufficient secretion of the anti-diuretic hormone arginine vasopressin (AVP) by the posterior pituitary (Melmed et al, 2017).

In the absence of specific treatment, diabetes insipidus can lead to severe ionic and osmotic disorders, mainly acute dehydration with the risk of severe consequences particularly neurological.

Monitoring for the appearance of diabetes insipidus is therefore necessary from the immediate post-operative period.

To date, diabetes insipidus is initially suspected before the appearance of major polyuria. Several biological assays (urinary density, natraemia, urinary osmolarity and plasma) can help to confirm the diagnosis, but the sensitivity and specificity of these biomarkers remains quite low for this indication.

The determination of MVA is difficult because this hormone is unstable ex vivo. To date, its use in current practice remains complicated.

MVA and copeptin are derived from the same precursor and are therefore co-secreted by the pituitary gland in equimolar proportions.

Copeptin has a relatively short in vivo half-life of about 25 minutes, as does MVA, but is more stable in vitro when blood has been drawn.

Its use in the early diagnosis of diabetes insipidus after pituitary surgery could therefore be of interest.

Detailed description: Objective is to study the interest of copeptin dosage as an early predictive marker for the diagnosis of post-operatice diabetes insipidus in trans-sphenoidal endoscopic pituitary surgery.

Eligibility criteria: inclusion criteria : adult patient patient undergoing pituitary surgery for tumour of the sellar region patient consenting to participate to the study patient enrolled in the national healthcare insurance program

exclusion criteria : Patient with preoperative diabetes insipidus. Patient undergoing pituitary surgery for suspicion of craniopharyngioma Patient undergoing pituitary surgery for pituitary metastases Patient under 18 years

Primary outcomes:
measure: Copeptin dosage
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT03551769: Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production
Official title: A Phase I, Open-label, Fixed-order, Single-dose, 2-Part, Crossover Study to Evaluate the Pharmacokinetics of a Formulation of Tricaprilin (AC-SD-01) Including the Effect of Food on Ketone Body Production in Caucasians and Asians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Cerecin
Sponsor class: INDUSTRY
First posted: 2018-06-11
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy adult male, ages 18 - 55
* Able to consume a regular diet and one high fat meal; no specific dietary requirements
* Cohort 2 (Asian subject population) restricted to being of Japanese or Chinese heritage

Exclusion Criteria:

* Presence of any illness or condition that, in the opinion of the investigator might confound the study results or poses risk to the subject
* Has been on a ketogenic diet as supported by review of a food diary
* Has positive Urine Drug Screen or alcohol results at Screening

Primary outcomes:
measure: Total ketones
timeFrame: 1 day
measure: Total ketones
timeFrame: 1 day
measure: Total ketones
timeFrame: 1 day
measure: Total ketones
timeFrame: 1 day
measure: Total ketones
timeFrame: 1 day
measure: B-hydrodxybutyrate
timeFrame: 1 day
measure: B-hydroxybutyrate
timeFrame: 1 day
measure: B-hydroxybutyrate
timeFrame: 1 day
measure: B-hydroxybutyrate
timeFrame: 1 day
measure: B-hydroxybutyrate
timeFrame: 1 day
measure: Acetoacetate
timeFrame: 1 day
measure: Acetoacetate
timeFrame: 1 day
measure: Acetoacetate
timeFrame: 1 day
measure: Acetoacetate
timeFrame: 1 day
measure: Acetoacetate
timeFrame: 1 day
Secondary outcomes:
measure: tricaprilin
timeFrame: 1 day
measure: tricaprilin
timeFrame: 1 day
measure: tricaprilin
timeFrame: 1 day
measure: tricaprilin
timeFrame: 1 day
measure: tricaprilin
timeFrame: 1 day
measure: tricaprilin
timeFrame: 1 day
measure: octanoic acid
timeFrame: 1 day
measure: octanoic acid
timeFrame: 1 day
measure: octanoic acid
timeFrame: 1 day
measure: octanoic acid
timeFrame: 1 day
measure: octanoic acid
timeFrame: 1 day
measure: octanoic acid
timeFrame: 1 day
measure: Computerized Cognitive Battery - Attention
timeFrame: 1 day
measure: Computerized Cognitive Battery - Episodic Memory
timeFrame: 1 day
measure: Computerized Cognitive Battery - Working Memory
timeFrame: 1 day
measure: Computerized Cognitive Battery - Psychomotor Function
timeFrame: 1 day
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
References:
Clinical trial NCT04603469: Hypotension in Children With Down Syndrome With Anesthesia Induction
Official title: Incidence of Hypotension in Children With Down Syndrome During Induction of Anesthesia With Sevoflurane
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension on Induction
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is an observational study of children with down syndrome undergoing induction of general anesthesia with sevoflurane. vital signs of blood pressure, heart rate and pulse oximetry will be recorded on the anesthesia record as standard practice

Brief summary: Children generally undergo induction of anesthesia by inhalation of sevoflurane. Children with Down Syndrome experience bradycardia with induction of anesthesia using sevoflurane. It is unknown if this bradycardia is isolate or results in hypotension, thus requiring treatment. Isolate bradycardia without hypotension does not require treatment and should be avoided as many of these patients have underlying cardiac anomalies.

Detailed description: Children generally undergo induction of anesthesia by inhalation of sevoflurane. This is particularly relevant for children with developmental delays as to avoid placement of an IV while awake. However, children with Down Syndrome experience bradycardia with induction of anesthesia using sevoflurane. It is unknown if this bradycardia is isolate or results in hypotension, thus requiring treatment. Isolate bradycardia without hypotension does not require treatment and should be avoided as many of these patients have underlying cardiac anomalies.

Eligibility criteria: Inclusion Criteria:

Children \<18 years old Requiring general anesthesia with inhalation induction Down syndrome ASA physical classification 1-3

Exclusion Criteria:

Patients \>18 years of age Patients without down syndrome Cyanotic congenital heart disease Use of antihypertensive medications Pulmonary hypertension patients undergoing intravenous induction of anesthesia ASA physical classification other than 1-3 emergency procedure

Primary outcomes:
measure: Assessment of non-invasive blood pressure during induction
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Adam Adler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01731769: Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure
Official title: Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure--- a Randomized Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Keywords: Seroma Formation
Axillary Lymph Node Dissection
Breast cancer
Early Vacuum Assisted Closure
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Axillary dissection is the standard treatment for breast cancer patients with positive nodes. However, seroma formation after axillary dissection remains the most common early complication to breast cancer surgery. It can delay the initiation of adjuvant therapy, predispose to wound infection, delay wound healing and has also been linked to arm lymphoedema. Based on some studies and our experience that vacuum assisted closure （VAC）is effective in complex wound failures following axillary dissection and groin dissection, we use VAC to prevent seroma formation after extensive axillary dissection. This study is aimed to evaluate the efficacy, safety and economics benefits of early VAC application on postoperative complications and wound healing after extensive axillary dissection in comparison to conventional suction drain.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* patients diagnosed with breast cancer, receiving modified radical mastectomy and axillary dissection；
* Body Mass Index ≥28；
* drainage volume within the first 48 hours is more than 200 mL.

Exclusion Criteria:

* Subjects with coagulation disorders shown by exceeding the normal range of any of following: prothrombin time (PT), Quick, activated partial thromboplastin time (aPTT), fibrinogen level, or thrombocytes.
* Subjects having previously had axillary surgery,
* Subjects having undergone irradiation therapy to the axillary tissue
* Subjects having ever received chemotherapy before the surgery,
* Subjects with known hypersensitivity to components of the surgical sticky membrane

Primary outcomes:
measure: seroma formation complication incidence
timeFrame: within the first 30 days (plus or minus 3 days) after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT02825069: Study on the Induction of Food Tolerance in Babies
Official title: Randomized Controlled Study on the Induction of Food Tolerance in Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Hypersensitivity
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 1214
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This general population based, randomized controled trial aims at answering two major hypotheses: First, systematic early introduction of solid foods decreases the incidence of food allergy and dietary restrictions by the age of one year. Second, stimulation with the symptom-eliciting food rather than avoidance will induce tolerance in babies with non-severe allergic symptoms.

Detailed description: All new born babies living in the city of Oulu are recruited to the study (n=1380) at their first health nurse visit (at or before 1 month of age) in the local primary care child health clinics. Families in the intervention group will get an instruction booklet including information on early systematic introduction of solid foods starting at the age of 4 months, with foodstuff from all major groups in diet by the age of 6 months (vegetables and fruits, wheat and other grains, meat, fish, egg, dairy products). Furthermore, the booklet includes information and instructions on food related symptoms and atopic eczema. Babies with mild symptoms are encouraged to continue the symptom-eliciting food. All families fill out monthly internet-based questionnaires on food diary, symptoms, diagnoses and health care visits until the age of 1 year.

Eligibility criteria: Inclusion Criteria:

* All newborn babies attending local Child Health Clinics

Exclusion Criteria:

* Parents unable to communicate with Finnish language (questionnaires in Finnish)

Primary outcomes:
measure: The number of patients with dietary restrictions due to food related symptoms
timeFrame: By the age of one year
Secondary outcomes:
measure: The number of children with doctor-diagnosed food allergies
timeFrame: By the age of one year
measure: The number of children with parent-reported food allergies
timeFrame: By the age of one year
measure: The number of children with doctor-diagnosed atopic eczema
timeFrame: By the age of one year
measure: The number of children with parent-reported atopic eczema
timeFrame: By the age of one year
measure: The number of health care contacts due to food related symptoms
timeFrame: By the age of one year
measure: Family experienced distress based on questionnaire
timeFrame: By the age of one year
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: PEDEGO Research Unit, University of Oulu and Oulu University Hospital
Study officials:
affiliation: PEDEGO-Research Unit and Medical Research Center Oulu, University of Oulu and Oulu University Hospital
name: Petri Kulmala, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: