louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04038710: Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
Official title: An Observational Study of the Effects on Clinical Outcomes of Expanded Access Program of Vertex Triple Combination Therapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at National Jewish Health with Cystic Fibrosis who are eligible to enroll in Vertex's triple combination therapy expanded access program.

Brief summary: This is an observational study of people with severe cystic fibrosis that are eligible for Vertex's triple combination therapy through its expanded access. Pulmonary health, intestinal health, and the overall health of individuals will be tracked for a year to see how effective triple combination therapy is in these people with severe cystic fibrosis disease.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Cystic Fibrosis
* Ability to reproducibly perform spirometry (according to ATS criteria)
* Physician decision to treat with TCT through the EAP program
* Ability to understand and sign a written informed consent or assent and comply with the requirements of the study

Exclusion Criteria:

* History of hypersensitivity to VX 445, VX 659, tezacaftor and/or ivacaftor
* Any acute lower respiratory symptoms treated with oral, inhaled or IV antibiotics or systemic corticosteroids within the 2 weeks prior to Visit 1.
* Major or traumatic surgery within 12 weeks prior to Visit 1.
* Initiation of any new chronic therapy (e.g., ibuprofen, Pulmozyme®, hypertonic saline, azithromycin, TOBI®, Cayston®) within 4 weeks prior to Visit 1.
* Use of an investigational agent within 28 days prior to Visit 1.
* History of lung or liver transplantation or listing for organ transplantation.

Primary outcomes:
measure: pulmonary function
timeFrame: For a year post initiation of therapy.
Secondary outcomes:
measure: CFQ-R score
timeFrame: For a year following the initiation of triple combination therapy.
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Derek Low, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00992810: Medial Versus Lateral Approach in Ultrasound (US)-Guided Supraclavicular Block
Official title: Medial vs. Lateral Approach to Ultrasound-Guided Supraclavicular Block: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand or Arm Surgery
Keywords: upper limb
hand
arm
surgery
supraclavicular nerve block
brachial plexus nerve block
ultrasound-guided regional anesthesia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2009-10-09
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ultrasound guided supraclavicular block is a peripheral nerve block which is considered safe, has a fast onset, is dense and provides complete block of the nerves supplying the hand, forearm and arm. However retrospective studies done at Toronto Western Hospital have highlighted the fact that most commonly the ulnar nerve fibres (responsible for sensations in the ring finger, little finger and the corresponding part of hand), sometimes escape this block and need additional supplementary block at a distal peripheral nerve site. It is a confusing fact since all nerve fibres are compactly arranged in a sheath at the supraclavicular level. The local anaesthetic agent at this level should be equally distributed among all nerve fibres. The purpose of this study is to compare two different approaches (medial and lateral) adopted by our clinicians to perform this block and to test the effectiveness of each approach for successful ulnar nerve fibre blockade.


Eligibility criteria: Inclusion Criteria:

* Adult patients presenting for upper limb surgery, excluding shoulder surgery
* Age 18-80 yrs
* BMI \< 35
* ASA I - III
* Consent for the study

Exclusion Criteria:

* Pre-existing sensory or motor neurodeficit.
* Sensitivity to local anaesthetic agents.
* Patients on anticoagulants or antiplatelet medications (Minidose Aspirin is acceptable) with abnormal coagulation profile.
* Compromised pulmonary reserve due to COPD, Kypho-scoliosis or Restricted lung disease.
* Infection or any obvious pathology at the site of block performance
* History of drug abuse.
* Psychiatric disease or any condition that precludes an informed consent.

Primary outcomes:
measure: Successful block of the Ulnar nerve (C8,T1) fibres. Sensory block with a score of '1' at 30 minutes (loss of sensation to pin prick) is considered successful.
timeFrame: 1 hour prior to surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Richard Brull, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05126810: Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling
Official title: Evaluate Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling Based on LFSPRO-ShinyApp Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Li-Fraumeni Syndrome
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-11-19
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Receive receiving genetic counseling specifically for TP53 genetic testing

Brief summary: This study evaluates patients willingness to participate in a trial comparing standard genetic counseling versus personalized genetic counseling. Collecting information from patients may help researchers learn why patients may or may not take part in the future study that compares standard genetic counseling to personalized genetic counseling.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate patients' willingness to participate in a future randomized trial comparing standard genetic counseling versus personalized genetic counseling based on Li-Fraumeni syndrome patient reported outcome (LFSPRO) ShinyApp data.

OUTLINE:

Patients complete a questionnaire over 15-20 minutes. Patients positive for a TP53 mutation complete an additional questionnaire over 15-20 minutes within 1 month after test results.

Eligibility criteria: Inclusion Criteria:

* Individuals age 15 or older OR parent/guardian of a patient younger than 15 years (if age 15-17, the patient will provide assent and parent/guardian will provide consent), pregnant women will also be allowed to participate
* English fluency
* Receive genetic counseling specifically for TP53 genetic testing and who consent to undergo TP53 genetic testing OR individuals whose genetic testing indicates a TP53 germline mutation

Exclusion Criteria:

* Individuals who are non-English speaking
* Individuals having low suspicion for a TP53 germline mutation during pretest counseling and test negative for a TP53 mutation

Primary outcomes:
measure: Patient willingness to participate in a future randomized trial comparing standard genetic counseling versus personalized genetic counseling based on LFSPRO ShinyApp data
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Banu Arun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06399510: Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis
Official title: Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment Diabetic Ketoacidosis, Electrolyte Balance Effects
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 58
Sex: ALL
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 goal of this prospective single centered randomized control trial is to compare the electrolyte balance effects between Sterofundin and Normal Saline in Diabetic Ketoacidosis patients. The main questions it aims to answer are:

i. Is there any difference in duration of bicarbonate (HCO3-) to reach equal or more than 15mmol/L from the initial blood taking in between Sterofundin and NS fluid use in DKA patients? ii. Is there any difference in the level of post-infusion serum sodium (Na+) between Sterofundin and NS fluid use in DKA patients? iii. Is there any difference in the level of post-infusion serum potassium (K+) between Sterofundin and NS fluid use in DKA patients?

Patients will be randomized in a 1:1 ratio to receive IV Sterofundin (intervention) or IV Normal Saline (standard care). The patient will have the respective fluid regime as the main fluid therapy during the first 24 hours of ICU stay. If patients were randomized to the control arm, the fluid regime for the first 24 hours in ICU will be normal saline. If patients were randomized to the interventional arm, the main fluid therapy during the first 24 hours of ICU stay will be Sterofundin.


Eligibility criteria: Inclusion Criteria:

* DKA.
* Aged ≥ 18 years old.
* Patients admitted to ICU \< 12 hours after initial fluid resuscitation from emergency department/ ward.

Exclusion Criteria:

* End stage renal failure
* Heart failure
* Started treatment of sodium bicarbonate infusion prior to ICU admission
* Known allergy to Sterofundin

Primary outcomes:
measure: The duration taken for serum HCO3 ≥ 15 within 24 hours ICU admission.
timeFrame: 24 Hours
measure: Mean difference of serum sodium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients
timeFrame: 24 Hours
measure: Mean difference of serum potassium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients.
timeFrame: 24 Hours
Secondary outcomes:
measure: The Need of Renal Replacement Therapy
timeFrame: 30 days
measure: Mechanical ventilation day
timeFrame: 30 days
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
Study officials:
References:
Clinical trial NCT04587310: Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study
Official title: Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett Esophagus
Lead sponsor: Jaber Al Ahmad Al Sabah Hospital
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 92
Sex: ALL
Minimum age (years): 24
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data was collected from 1639 patients. 92 patients fit our inclusion criteria. Data was then analyzed and summarized against similar literature

Brief summary: Introduction Laparoscopic Sleeve Gastrectomy (LSG) is one of the most prevalent approaches to tackle obesity and its co-morbidities. The main complication following the LSG is Gastro-esophageal reflux disease (GERD), with most patients developing worsening symptoms of GERD, and a small number progressing to Barrett's esophagus. This retrospective analysis aims to assess the rate of GERD pre- and post- LSG as well as the rate of progression to Barrett's.

Methods Data was collected from 1639 patients. 92 patients fit our inclusion criteria. Data was then analyzed and summarized against similar literature


Eligibility criteria: Inclusion Criteria:

* patients eligible to sleeve gastrectomy that had an EGD pre and 5 years post-op

Exclusion Criteria:

* missing or implausible data, had multiple surgeries, and suffered from the common post-sleeve complications, such as leaks, strictures and hiatal hernias

Primary outcomes:
measure: endoscopy performed on patients
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01329510: Sleep and Nocturnal Melatonin in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: The Effects of Methylphenidate on Sleep Patterns in Adults With ADHD: An Open Label Polysomnographic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Adult
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-04-06
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will investigate the effects of methylphenidate on sleep in adults with Attention Deficit/ Hyperactivity Disorder (ADHD) using polysomnographic parameters.

Detailed description: Previous studies in children with Attention Deficit/ Hyperactivity Disorder (ADHD) have described the effect of stimulants on sleep patterns. However the data on adults with ADHD is sparse.

The aim of this study is to investigate the effects of methylphenidate on sleep in adults with ADHD using polysomnographic parameters.

Eligibility criteria: Inclusion Criteria:

* ADHD according to DSM-IV Criteria
* Positive ASRS questionnaire

Exclusion Criteria:

* Brain damage
* Brain encephalopathy
* Borderline IQ
* Affective disorder

Primary outcomes:
measure: polysomnographic parameters
timeFrame: one- night (day 1)
Secondary outcomes:
measure: sleep questionnaire
timeFrame: one week
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical Center
name: Michael Khaigrekht, MD
role: STUDY_DIRECTOR
affiliation: Memory, Attention And Learning Disabilities Unit, Assaf Harofeh Medical Center
name: Ran Shorer, M.A.
role: STUDY_DIRECTOR
affiliation: Neurology Department , Assaf Harofeh Medical Center
name: Martin Rabey, MD
role: STUDY_DIRECTOR
affiliation: Sleep And Snoring Clinic, Assaf Harofeh Medical Center
name: Itzhak Shpirer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memory, Attention And Learning Disabilities Clinic, Assaf Harofeh Medical Center
name: Shoky Shavit, M.A
role: STUDY_DIRECTOR
References:
Clinical trial NCT02173210: Precision Medicine for Preterm Birth
Official title: Precision Medicine In Segregating Endotypes in Preterm Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Keywords: Premature birth
Premature delivery
Metabolomics
Microbiota
Genetics
17 hydroxyprogesterone caproate
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 380
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with a singleton gestation who have had a prior spontaneous preterm birth.

Brief summary: This project is examining genetic and metabolic markers for the use of 17 hydroxyprogesterone caproate (17OHPC) in pregnant women with a history of preterm birth (PTB). 17OHPC has been associated with a 30-35% reduction in repeat PTB in women carrying a singleton gestation. However, it is not well known why it works for some women but not for others. There are limited available interventions for the prevention of recurrent PTB. This study will enroll 150 women at risk for PTB and eligible to receive 17OHPC, and expect that 80% will use 17OHPC and 20% will decline use. We will obtain blood samples and samples of cervical cells and cervical vaginal fluid. The objective of the study is to identify genetic, microbial and molecular markers that help to identify which women at risk for recurrent preterm birth will respond to 17OHPC and which women will not. The ultimate goal is to develop a personalized screening test based on these markers.

Detailed description: Women with a prior preterm birth will be recruited between 16 and 22 weeks gestation. At this initial time point, samples of cervical epithelial cells and cervicovaginal fluid will be collected. Approximately 8 weeks later, those samples will be collected a second time, along with a blood sample. Outcome data will be collected after delivery.

Eligibility criteria: Inclusion Criteria:

* Women with a prior spontaneous preterm birth of a singleton pregnancy (delivered at 16-36 6/7 weeks gestation)
* Singleton in the current pregnancy
* Eligible to use 17 hydroxyprogesterone caproate (17OHPC) in this pregnancy for clinical indications
* 16-22 weeks gestation at the time of visit 1 assessments

Exclusion Criteria:

* Major fetal anomaly
* Allergy to 17OHPC

Primary outcomes:
measure: Preterm Birth
timeFrame: At time of delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michal Elovitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03850210: The Manchester Short Splint in the Rehabilitation of Zone II Flexor Tendon Repairs
Official title: The Manchester Short Splint in the Rehabilitation of Zone II Flexor Tendon Repairs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendon Injuries
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2019-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The project sets out to compare two different splints in the outcome of zone II flexor tendon injury hand therapy rehabilitation programme. Traditional hand therapy is based on using a long forearm-based splint for 6 weeks in zone II flexor tendon injuries. Manchester University NHS Foundation Trust have devised a new shorter splint to use as an alternative to the traditional longer splint as there are cogent reasons for believing that permitting more wrist movement during rehabilitation will improve the range of finger movement ultimately (tendonesis effects).

Patients will be randomised to receive either the traditional long splint, or the short splint. Patients will be followed up and data will be collected at routine hand therapy appointments.


Eligibility criteria: Inclusion Criteria:

* Adult male and female patients 16 years and over, undergoing surgical repair of zone II flexor tendon injury in a single digit

Exclusion Criteria:

* Adult patients lacking capacity or motivation to participate in the planned physiotherapy
* Adult patients with special needs and vulnerable groups
* Adult patients who undergo surgical repair of their flexor tendon more than 4 days after the initial injury
* Patients unable to understand English adequately
* Adult patients unable to attend the hospital facility for the requisite number of planned physiotherapy sessions (social reasons)
* Adult patients with multiple level injuries
* Injuries with soft tissue loss requiring coverage
* Adult patients with two nerve injuries on the same finger
* Adult patients with multiple digit flexor tendon injury
* Adult patients with concomitant bony injury to the hand
* Children under 16 years age

Primary outcomes:
measure: Change in range of motion of the proximal interphalangeal joint of the injured digit at baseline and 6 months
timeFrame: Active and passive motion ranges to be recorded at 3 and 6 months
Secondary outcomes:
measure: Rupture of repaired flexor tendon
timeFrame: Monitored at 3 and 6 months
measure: Tendon adhesions needing tenolysis
timeFrame: Monitored at 3 and 6 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
References:
Clinical trial NCT03881410: The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor
Official title: The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Tumor
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 413
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To use the shear-wave elastography to assist the transthoracic ultrasound-guided aspiration biopsy of peripheral lung tumor

1. To identify the intra-tumor heterogeneity of elasticity
2. To increase the diagnostic yield in ultrasound-guided transthoracic biopsy of subpleural pulmonary tumor


Eligibility criteria: Inclusion criteria:

(1) Patients with radiographic evidence of pulmonary lesions

Exclusion criteria:

1. Age \< 20 y/o
2. Patients who cannot hold their breath for 5 seconds
3. Inadequate shear-wave propagation of lung tumor

Primary outcomes:
measure: The diagnostic yield between two groups
timeFrame: 6 months
Secondary outcomes:
measure: Total times of the biopsy
timeFrame: 1 day
measure: Procedure duration
timeFrame: 1 day
measure: Complication rate
timeFrame: 1 day
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yao-Wen Kuo
role: PRINCIPAL_INVESTIGATOR
References: