louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02647580: Appetite Regulation in Children With Failure to Thrive
Official title: Appetite-regulating Hormones, the Gut Microbiome and the Metabolome in Children With Failure to Thrive
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Failure to Thrive
Keywords: Growth
Children
Appetite-regulating hormones
Gut Microbiota
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
name: Technical University of Denmark
First posted: 2016-01-06
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with failure to thrive

Brief summary: Failure to thrive (FTT) is an expression for inadequate growth in the early childhood and thus, a sign of undernutrition. This study will include children with FTT, and compare with existing data from children with normal and excessive growth.

The overall aim of this study is to explore whether 1) children who develop FTT with no organic explanation differ from healthy normal weight and overweight children in their basal level of appetite-regulating hormones and 2) if inadequate, normal and excessive growth in children can be partly predicted by variation in their gut microbiome and metabolome.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with failure to thrive
* Weight for height \> 1.9 SD below the median by use of the WHO Child Growth Standards
* Age between 12-36 months

Exclusion Criteria:

* Cancer
* Inflammatory bowel disease
* Celiac disease
* Immunodeficiency
* Other somatic disease that can explain the growth failure

Primary outcomes:
measure: Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples
timeFrame: At subject enrollment
Secondary outcomes:
measure: Microbiota composition measured by fecal samples
timeFrame: At subject enrollment
measure: Metabolome measured by urine samples
timeFrame: At subject enrollment
measure: Metabolic markers (insulin, glucose) measured by fasting blood samples
timeFrame: At subject enrollment
measure: Body weight measured in kilograms
timeFrame: At subject enrollment
measure: Height measured in centimeters
timeFrame: At subject enrollment
measure: Head circumference measured in centimeters
timeFrame: At subject enrollment
measure: Waist circumference measured in centimeters
timeFrame: At subject enrollment
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References:
Clinical trial NCT01680380: Tracking Breathing During Sleep With Non-contact Sensors
Official title: Tracking Breathing During Sleep With Non-contact Sensors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleep Apnea Syndromes
Snoring
Keywords: sleep apnea
snoring
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the PI's department (OHSU faculty, Ph.D. students) by email and the investigators' personal acquaintances. Participants must be age 21-100 and have no self-reported sleep breathing problems.

Brief summary: The purpose of this study is to evaluate the feasibility of tracking breathing during sleep with non-contact sensors (for example, microphones or wireless movement sensors). The investigators will use the data collected with these sensors to develop algorithms for tracking breathing during sleep. The investigators will assess the performance of the algorithms by comparing automatic output against manually-generated labels.

Detailed description: Subjects will be asked to place non-contact sensors (for example, ambient microphones, wireless movement sensors) in their home sleep environment. No sensors will be attached to or otherwise in contact with the subject's body. The subjects will start the data collection before they fall asleep, and stop the data collection the next morning when they wake. The subjects will then return the sensors to the investigator for analysis.

The investigators will study the data and associated manual labeling. The investigators will develop algorithms that use statistical and machine-learning methods to train computer models designed to track breathing automatically. The investigators will compare the automatic output against manually generated labels to determine breath-tracking accuracy.

Eligibility criteria: Inclusion Criteria:

* Age 21-89
* No self-reported sleep breathing problems

Exclusion Criteria:

* Positive diagnosis for sleep breathing problem (e.g., obstructive sleep apnea)

Primary outcomes:
measure: Breathing sounds are evident in overnight audio recordings
timeFrame: Night of recording
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Center for Spoken Language Understanding
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alexander Kain, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02345980: A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms
Official title: A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Quality of Life
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 94
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite its beneficial effect, ureteral stents may produce symptoms (such as hematuria, dysuria, frequency, urgency, urge incontinence and suprapubic or flank pain) that affect the quality of life in 70-80%.

This study will be conducted to evaluate the role of Phosphodiestrase 5 inhibitor (Sildenafil Citrate) in relieving these symptoms.

Detailed description: Adult patient (\>18 years) who will undergo ureteral stent fixation after endoscopic procedures will be randomized between the study arms.

Exclusion criteria:

1. Patients who had lower urinary tract symptoms before stent fixation.
2. Ureteral stent fixation after open surgery.
3. Known contraindications to Sildenafil Citrate

Eligibility criteria: Inclusion Criteria:

1. Patient aged \>18 years

Exclusion Criteria:

1. Patients who had LUTS before DJ stent fixation
2. DJ stent fixation after open surgery
3. Contraindication to Sildenafil citrate

Primary outcomes:
measure: Ureteral Stent Symptoms Questionnaire (USSQ) Score
timeFrame: 2-4 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 2-4 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center, Mansoura University
Study officials:
affiliation: Urology and Nephrology Center, Mansoura University, Egypt
name: Ahmed R EL-Nahas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tharwat M, Elsaadany MM, Lashin AM, El-Nahas AR. A randomized controlled trial evaluating sildenafil citrate in relieving ureteral stent-related symptoms. World J Urol. 2018 Nov;36(11):1877-1881. doi: 10.1007/s00345-018-2339-y. Epub 2018 May 15.
Clinical trial NCT01915680: Intraocular Pressure Fluctuation in Patients With Glaucoma and in Healthy Patients During Standard Yoga Positions
Official title: Intraocular Pressure Fluctuation in Patients With Glaucoma and in Healthy Patients During Standard Yoga Positions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Intraocular Pressure
Lead sponsor: Robert Ritch, MD, LLC.
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma Practice and Yoga Studios

Brief summary: The purpose of the study is to investigate the IOP difference between normal and glaucomatous eyes using standard ophthalmic tonometry devices while subjects are performing different standard yoga asanas. The IOP of participants will be measured prior, immediately at start of the asana, 2 minutes into the asana, and immediately after assuming a sitting position. The patient will wait 10 minutes and a final IOP will be taken. Four standard yoga asanas will be tested.


Eligibility criteria: Inclusion Criteria:

* Glaucoma or healthy control
* Practice yoga
* 18-80 years old
* Practice Yoga for a minimum of 12 months

Exclusion Criteria:

* Healthy subjects do not have normal ophthalmic exam
* Cannot maintain yoga positions

Primary outcomes:
measure: Change in Intraocular Pressure
timeFrame: Change from Baseline, Immediate, 2 Minutes, Post, 10 min Post
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Glaucoma Associates of New York
state: New York
Study officials:
References:
citation: Jasien JV, Jonas JB, de Moraes CG, Ritch R. Intraocular Pressure Rise in Subjects with and without Glaucoma during Four Common Yoga Positions. PLoS One. 2015 Dec 23;10(12):e0144505. doi: 10.1371/journal.pone.0144505. eCollection 2015.
Clinical trial NCT00210080: A Study to Diagnose Lung Cancer by Sputum Cytology (01-312)
Official title: A Double-Blind, Placebo-Controlled, Parallel Group Study of Uridine 5'-Triphosphate (UTP) Solution for Inhalation as an Adjunct in the Diagnosis of Lung Cancer by Sputum Cytology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 700
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine if more diagnoses of lung cancer are obtained from the cytological evaluation of sputum expectorated following a single inhaled dose of UTP compared to sputum expectorated following a single inhaled dose of placebo in patients suspected of having lung cancer.


Eligibility criteria: Inclusion Criteria:

* be suspected of having primary lung cancer based upon chest radiograph(s), CT scan(s), or PET scan(s) and with symptom, risk profile, or history suggestive of malignancy
* have FEV1 greater than or equal to 40% predicted normal for age and height

Exclusion Criteria:

* have obtained a confirmed diagnosis for the current suspicious lung tumor
* have been treated for the current, suspicious tumor except in cases in which the current lesion is the recurrence of the same tumor (same location) for which treatment was administered no less than 180 days prior to screening
* have undergone a bronchoscopic examination or pulmonary fine needle aspiration biopsy within 4 days prior to dosing, or have undergone sputum induction within 3 days prior to dosing

Primary outcomes:
measure: Proportion of lung cancers (malignancies) diagnosed by sputum cytology
Secondary outcomes:
measure: Proportion of centrally and peripherally located lung cancers diagnosed by sputum cytology;
measure: Proportion of small and large lung cancers diagnosed by sputum cytology;
measure: Proportion of lung cancers of various cell types, stages and resectability diagnosed by sputum cytology;
measure: Wet weight of sputum expectorated;
measure: Macrophage content of sputum
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06457880: PENG Block vs FNB + ONB in Patients Undergoing Hip Fracture Surgery With Contraindications to Neuraxial Anesthesia
Official title: Pericapsular Nerve Group (PENG) Block vs Femoral Nerve Block (FNB) + Obturator Nerve Block (ONB) in Patients Undergoing Hip Fracture Surgery With Contraindications to Neuraxial Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Pain, Postoperative
Coagulopathy
Comorbidities and Coexisting Conditions
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 40
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: The aim of the study is to demonstrate the efficacy of PENG block as the main anesthetic technique to manage perioperative analgesia for hip fracture surgery compared to femoral and obturator nerve block in patients with contraindications to spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* patients undergo hip surgery
* patients with contraindications at spinal anesthesia

Exclusion Criteria:

* allergy at local anesthetic
* age under 18 or weight under 30

Primary outcomes:
measure: preoperative pain
timeFrame: 30 minutes
measure: Pain following regional anesthesia
timeFrame: 30 minutes
measure: Postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: Morphine milligrams (mg) consumption
timeFrame: 24 hours
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Campus Bio Medico
Study officials:
References:
Clinical trial NCT03088280: Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen
Official title: Prospective Randomized Study to Evaluate the Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg vs. 6mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thymoglobulin Dose
Lead sponsor: Hospital Geral de Fortaleza
Sponsor class: OTHER_GOV
First posted: 2017-03-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Single-center, prospective, randomized, open-label clinical trial to evaluate the 1-year efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk patients receiving low exposure tacrolimus plus everolimus (EVL) in a steroid-free protocol.


Eligibility criteria: Inclusion Criteria:

* Primary kidney transplant recipients, adults

Exclusion Criteria:

* PRA \> 50%
* DSA \> 1500 MFI
* Retransplantation
* Patients who are planning to receive mycophenolate instead of everolimus
* Patients who have planning for follow-up in another center

Primary outcomes:
measure: Acute rejection
timeFrame: 1 year
Secondary outcomes:
measure: Infection
timeFrame: 1 year
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Transplant ward of the Hospital do Fortaleza
state: Ceará
Study officials:
References:
Clinical trial NCT00355680: Green Laser Photocoagulation Study in Proliferative Diabetic Retinopathy
Official title: Comparative Study of Indigenous Green Laser With Already Available Green Laser in Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Retinopathy
Keywords: Retina
Retinal Diseases
Retinal Vessels
Laser Coagulation
Lead sponsor: Aurolab
Sponsor class: OTHER
Collaborators: name: Raja Ramanna Centre for Advanced Technology (RRCAT)
First posted: 2006-07-24
Enrollment: 24
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 Demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser.

Detailed description: Proliferative Diabetic Retinopathy is ocular pathology in poor glycaemic controlled Diabetic patient Characterized by micro-vascular pathology with capillary closure in the retina leading to hypoxia of tissue there by formation of immature vessels to provide better oxygenation of retinal tissue.

In this randomized double blinded study a convenient sample size of 24 eyes assigned to compare indigenously developed green laser with already available green laser.

Eligibility criteria: Inclusion Criteria:

* Patients more than 18 years of age
* Eyes with proliferative diabetic retinopathy requiring laser photocoagulation

Exclusion Criteria:

* Eyes with media opacities not allowing proper fundus photography or adequate laser photocoagulation
* Patients requiring more than two sessions of laser photocoagulation
* Patients who had undergone previous laser photocoagulation
* Patients who had undergone any previous vitreo-retinal surgery

Primary outcomes:
measure: Pigmentation of burn
timeFrame: 2 months, 4 months, 6 months post laser
measure: Lateral spread of burn
timeFrame: 2 months, 4 months, 6 months post laser
measure: Regression of new vessels
timeFrame: 2 months, 4 months, 6 months post laser
Secondary outcomes:
measure: Choroidal detachment
timeFrame: 2 months, 4 months, 6 months post laser
measure: Retinal detachment
timeFrame: 2 months, 4 months, 6 months post laser
measure: Tractional retinal detachment
timeFrame: 2 months, 4 months, 6 months post laser
measure: Bruch's membrane rupture
timeFrame: 2 months, 4 months, 6 months post laser
Other outcomes:
Locations:
city: Madurai
country: India
facility: Arvind Eye Hospital
state: Tamil Nadu
Study officials:
affiliation: Arvind Eye Hospital, Madurai
name: Chandra Mohan, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Aravind Eye Hospital
name: Dhananjay Shukla, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Aravind Eye Hospital
name: Naresh Babu, MS, FNB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04626180: EFFECT OF PRE EXTUBATION MANUAL HYPERINFLATION TECHNIQUE VS REGULAR EXTUBATION AFTER STERNOTOMY
Official title: Effects of Pre-extubation Manual Hyper Inflation in Comparison to Regular Extubation Following Sternotomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sternotomy
Keywords: Sternotomy
Extubation
Manual Hyperinflation
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post operative pulmonary complication (PPC) is one of the cause of mortality and morbidity after sternotomy. There is no accessible confirmation which shows the impact of Pre Extubation Manual Hyperinflation method with Regular Extubation procedure. After sternotomy manual hyperinflation technique is not taken during extubation. The objective of the study was to determine the effect of Pre Extubation Manual Hyperinflation technique VS regular Extubation technique on vitals and respiratory parameters in patients after Sternotomy.


Eligibility criteria: Inclusion Criteria:

1. Age 40 to 60
2. Patient undergone surgery (sternotomy)
3. Elective intubated (ETT orally)
4. Ventilated more than 3 hours -

Exclusion Criteria:

1. Patient with any neurological issue (mentally disturbed) who cannot understand the command
2. Complicated extubation
3. Pulmonary pathology where lung hyperinflation was contra-indicated (e.g. acute respiratory distress syndrome, undrained pneumothorax or exacerbation of chronic obstructive pulmonary disease and acute pulmonary edema.
4. Raised intracranial pressure
5. Redo or reopen. -

Primary outcomes:
measure: Peak expiratory flow rate
timeFrame: 1 day
measure: Blood pH
timeFrame: 1 day
measure: Blood pO2
timeFrame: 1 day
measure: Blood pCO2
timeFrame: 1 day
measure: Blood pHCO3
timeFrame: 1 day
measure: Pulse rate
timeFrame: 1 day
measure: Oxygen saturation
timeFrame: 1 day
measure: Forced expiratory volume
timeFrame: 1 day
measure: Forced vital capacity
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Bahria International Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00953680: Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)
Official title: An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Bioequivalence After Administration of a Losartan 100-mg/Hydrochlorothiazide 12.5-mg Combination Tablet and the Coadministration of a Currently Marketed COZAAR™ 100-mg Tablet and MICROZIDE™ 12.5 mg Capsule in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.


Eligibility criteria: Inclusion Criteria:

* Subject is a healthy male or female between the ages of 18 and 45 years of age
* Subject does not smoke

Exclusion Criteria:

* Subject has a history of any illness that might pose additional risk to participation or confound the results of the study
* Subject has a history of hepatitis B or C or significant drug allergies

Primary outcomes:
measure: Area Under the Curve (AUC(0 to Infinity)) of Losartan
timeFrame: 0 to 36 Hours Post Dose
measure: Peak Plasma Concentration (Cmax) for Losartan
timeFrame: 36 Hours Post Dose
measure: Area Under the Curve (AUC(0 to Infinity)) of HCTZ
timeFrame: 0 to 30 Hours Post Dose
measure: Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ
timeFrame: 30 Hours Post Dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: