louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00051896: Assessment of the Potential Interactions Between Cocaine and GBR 12909 - 1
Official title: Double-Blind, Placebo-Controlled, Dose Escalating, Safety and Pharmacology Study With Three Dosages of GBR 12909 in Cocaine Experienced Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2003-01-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the potential interactions between iv cocaine and GBR 12909.

Detailed description: This is a single dose with escalation, double-blind, placebo-controlled inpatient study in which 24 cocaine experienced volunteers that meet protocol eligibility criteria during a 30 day screen period will be randomized into three dose groups.

Eligibility criteria: Inclusion Criteria:

* Must understand study procedures and provide written informed consent
* For additional inclusion criteria information, please contact study site for more information.

Exclusion Criteria:

* Please contact study site for more information.

Primary outcomes:
measure: Pharmacokinetic parameter comparison
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of Health Science
state: Maryland
Study officials:
affiliation: Uniformed Services University of Health Science
name: Louis Cantilena, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01955096: Fast Track Surgery With Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer: a Randomized Controlled Trial
Official title: Fast Track Surgery With Laparoscopic-assisted Gastrectomy for Advanced Gastric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: fast-track surgery, laparoscopic gastrectomy
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 61
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to to investigate the feasibility and safety of fast-track surgery when combined with laparoscopic-assisted gastrectomy for advanced gastric cancer patients.

Detailed description: Methods: We designed a prospective randomized, controlled clinical trial then recruited 61 consecutive advanced gastric cancer patients. (Trial registration number: JLUFHC1722013) Further divide into a fast-track surgery group (n=30) and a conventional surgery group (n=31). Surgical technique in both groups is same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compare outcomes includes length of hospital stay, return to normal diet and postoperative complications.Results: Recovery parameters such as the length of time to return to normal diet; to the first defection; start of ambulation time ;the mean hospital stay will be all less in patients assigned to the fast track surgery protocol compared with those in the conventional care programme. Conclusion: We will consider fast-track rehabilitation to be safe and feasible in advanced gastric cancer patients. Moreover, it will result in decreased hospital stay.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced gastric cancer, elective laparoscopic surgery and age under 75.

Exclusion Criteria:

* Patients with early gastric cancer, received neoadjuvant chemotherapy, had pyloric obstruction or with distant metastasis were excluded from the study.

Primary outcomes:
measure: Ambulation time
timeFrame: within the first 30 days (plus or minus 3 days) after surgery
measure: defection time
timeFrame: within the first 30 days (plus or minus 3 days) after surgery
measure: food intake time
timeFrame: within the first 30 days (plus or minus 3 days) after surgery
Secondary outcomes:
measure: Complications
timeFrame: one year
measure: readmission
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06005896: A Clinical Model for Dialysis Discontinuation in AKI
Official title: A Clinical Model to Predict Successful Renal Replacement Therapy (RRT) Discontinuation in Patients With Acute Kidney Injury (AKI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Renal Failure
Acute Kidney Injury
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients from a large tertiary care hospital receiving kidney replacement therapy due to AKI.

Brief summary: A retrospective study evaluating AKI patients in whom RRT was interrupted for at least 48 hours. Patients who were still RRT-independent 7 days after initial RRT cessation were included in the "Success" group, as opposed to the "Failure" group. Baseline characteristics and variables at the time of RRT interruption were collected. Multivariable analysis was performed and a model was generated to evaluate the prediction of success.


Eligibility criteria: Inclusion Criteria:

* All patients receiving kidney replacement therapy due to AKI from October 2020 to February 2022 were considered for inclusion in the study. Patients who managed to remain at least 48 consecutive hours without receiving kidney replacement therapy prescription were included.

Exclusion Criteria:

* Patients who had kidney replacement therapy interrupted exclusively due to haemodynamic instability, death or decision for palliative care were excluded.

Primary outcomes:
measure: Success in RRT discontinuation
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo School of Medicine
state: SP
Study officials:
References:
Clinical trial NCT02381158: Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing
Official title: Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wheezing
Keywords: Wheezing
Children
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 12
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg nebulized), on airway resistance and reactances (measured with Rint and FOT techniques) in children with recurrent wheezing, aged 2-5 years. In addition, clinic score as frequency of symptoms and exacerbations, will be assessed.


Eligibility criteria: Inclusion Criteria:

* Informed and subscribed consent before any procedure
* Age range : 2 - ≤5 years
* Male and female patients
* Recurrent wheezing affected ( ≥ 4 episodes in the last 12 months)
* PAI positive (at least one primary and two secondary ):

Primary:

1. one parent with asthma
2. Atopic Dermatitis
3. sensibilisation to air allergen

Secondary:

1. Food sensibilization
2. wheezing also not during the infective episodes
3. eosinophilia (\>4%)

Exclusion Criteria:

* story of severe wheeze requiring hospitalization
* treatment with inhaled glucocorticoids during the previous 4 weeks or with oral glucocorticoids in the previous 8 weeks
* structural abnormalities of the lungs (tracheobronchial bronchomalacia, external compressions, etc)
* Persistent infections
* aspiration lung disease (gastroesophageal reflux disease, etc.)
* Cystic fibrosis
* prematurity or bronchopulmonary dysplasia
* Tuberculosis
* primary ciliary dyskinesia
* congenital heart disease
* pulmonary foreign body
* bronchiectasis
* Immunodeficit

Primary outcomes:
measure: Lung fuction with Rint and FOT
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05096858: Continuous Glucose Monitorization in Hospitalized Patients With COVID-19
Official title: Assessment of the Effect of Continuous Glucose Monitorization on Glycemic Variability and Insulin's Prescription in Hospitalized Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Covid19
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults living with diabetes and suffering from COVID19 pneumonia

Brief summary: DM2 is a major comorbidity of COVID-19. It has been observed that subjects with DM2 require more medical interventions, have a significantly higher mortality (7.8% versus 2.7%) and injuries of multiple organs that the individuals not diabetics.

In situations of glycemic variability, phenomena of oxidative stress and activation of protein kinase C can be initiated , through the release of pro-inflammatory cytosines , which could induce microvascular damage .Patients with diabetes and COVID-19 were shown to be more likely to develop serious or critical illness with more complications, and to have higher incidence rates of antibiotic therapy, non-invasive and invasive mechanical ventilation, and death (11.1% vs. 4.1%).


Eligibility criteria: Inclusion Criteria:

* Confirmed COVID-19 pneumonia
* Diabetes mellitus

Exclusion Criteria:

* Less than 3 days of hospital care

Primary outcomes:
measure: Glucose variability
timeFrame: For up to two weeks, during hospitalization
measure: Insulin use
timeFrame: For up two weeks, during hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Medical Sciences and Nutrition Salvador Zubiran
Study officials:
affiliation: INCMNSZ
name: ALFONSO GULIAS HERRERO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02785458: Testing a Medication Risk Communication and Surveillance Strategy: The EMC2 Trial
Official title: Testing a Medication Risk Communication and Surveillance Strategy: The EMC2 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High-risk Medications
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Boston Medical Center
name: University of North Carolina, Chapel Hill
name: University of Illinois at Chicago
First posted: 2016-05-27
Enrollment: 1005
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates the effectiveness of an electronic health record based educational intervention (the EMC2 strategy) to improve patient understanding and use of higher-risk medications. Half of the participants will receive the intervention, while the other half will receive the usual amount of information (usual care).

Detailed description: Research has repeatedly demonstrated that individuals lack essential information on how to safely take prescribed (Rx) medications. A risk communication and surveillance strategy is needed in primary care to ensure that patients are adequately informed about medication risks and are taking prescribed regimens safely.

The investigators devised an Electronic health record-based Medication Complete Communication (EMC2) Strategy that leverages electronic health record (EHR) and interactive voice response (IVR) technologies to:

1. prompt and guide provider counseling,
2. automate the delivery of Medication Guides at prescribing,
3. follow patients post-visit to confirm prescription understanding and use, and
4. deliver a care alert back to providers to inform them of any potential harms.

Eligibility criteria: Inclusion Criteria:

* 21 and older
* English or spanish speaking
* Primarily responsible for administering own medications
* New prescription of one of 66 study medications on day of recruitment
* Has a personal mobile or land line phone

Exclusion Criteria:

* Severe, uncorrectable vision
* Hearing or cognitive impairments

Primary outcomes:
measure: Medication Knowledge (0-100)
timeFrame: Baseline to 3 Months post baseline
Secondary outcomes:
measure: Probability of Prescription Medication Proper Use
timeFrame: 1 Month post baseline to 3 Months post baseline
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Near North Health Services Corporation
state: Illinois
Study officials:
affiliation: Northwestern University
name: Michael S Wolf, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Stacy C Bailey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Michael K Paasche-Orlow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06530758: Does the Format of the Adult ADHD Self-Report Scale Impact the Results
Official title: Does the Format of the Adult ADHD Self-Report Scale Impact the Results: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 587
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: The World Health Organization Adult ADHD Self-Report Scale v1.1 (ASRS) is frequently used in family medicine clinics to screen for ADHD. Numerous studies have found the ASRS has a low positive predictive value. Compounding this concern is the format of the ASRS. Specifically, the answers on the ASRS that lead to screen positive results are shaded in gray and grouped together, which may make it easy for patients to discern which responses should be selected for a positive screen.

Detailed description: The ASRS is used widely to screen for ADHD in adults. It has 18 questions, with response options "never," "rarely," "sometimes," "often," and "very often." The 6 questions considered most predictive of ADHD are grouped together in Part A and questions that are meant to provide additional cues are grouped together in Part B. The options that are considered a positive response vary between questions; for some questions the option is at least "sometimes," while for others it is at least "often." The positive response options are shaded on the ASRS. A person is considered to have a positive screen if 4 of the 6 questions in Part A are positive.

The objective of this trial is to determine if the shading and grouping on the ASRS impacts screening results. This trial has a 2x2 factorial design set in a family medicine clinic(s). When a patients check in for an appointment, clinic staff will offer them a survey that includes 1) demographic questions and 2) 1 of the 4 versions of the ASRS, the version they receive is randomized (with programming). Most patients will take approximately 5 minutes to complete the survey prior to them seeing the family physician.

Eligibility criteria: Inclusion Criteria:

* 19 - 65 years old
* Patients who are registering for their appointment at the family medicine clinic
* Patients who are expected to be in the reception area for ≥5 minutes before going to a clinic room

Exclusion Criteria:

* Any patients who do not have the capacity to complete the form (e.g., cognitive impairment, unable to read English, unable to use a computer)

Primary outcomes:
measure: Screen positive rate
timeFrame: Through study completion, estimated to be 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Shifa Medical Clinic
state: Alberta
Study officials:
affiliation: University of Alberta
name: Roni Kraut
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03384758: Evaluation of Compression Therapy in Patients With Mild to Moderate PAD or Diabetes Mellitus
Official title: Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Diabetes Mellitus
Leg Edema
Keywords: Compression therapy
Microcirculation
Diabetes mellitus
Peripheral Arterial Disease
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.

Detailed description: Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus. The microcirculation should be assessed by a combination of laserdoppler flowmetry and white light tissue spectrometry (O2C Device, Parameters sO2, Flow, rHb). By this, it is possible to detect the influence of the compression therapy on the skin microcirculation.

Therefore, three study arms should be investigated, all patients clinically suffering under leg edema: healthy volunteers, patients with mild to moderate PAD and diabetics. All patients are recieveing compression therapy (Compression stockings class I for three hours, after a short break compression stockings class II for 3 hours) under Perfusion assessment control (O2C device).

Eligibility criteria: Inclusion Criteria:

Study-Arm PAD:

* leg edema
* symptomatic PAD (Fontaine stage II)
* no palpable foot pulses
* ABI \<0.9 and \>0.6, absolute ankle pressure \> 60mmHg

Study-Arm Diabetes:

* leg edema
* Diabetes mellitus Typ 2 (history of longer than 2 years)
* palpable foot pulses
* Pallaesthesie \>6
* Wagner Score 0

Exclusion Criteria:

Study-Arm PAD:

* Critical limb ischemia
* ABI \< 0.6
* simoultaneous Diabetes Mellitus

Study-Arm Diabetes:

* Wagner Score \>0
* Pallasthesie \<6

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by questionnaire
timeFrame: 12 Months
measure: sO2
timeFrame: 12 Months
measure: Flow
timeFrame: 12 Months
measure: rHb
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen, Vascular Surgery
Study officials:
References:
citation: Rother U, Grussler A, Griesbach C, Almasi-Sperling V, Lang W, Meyer A. Safety of medical compression stockings in patients with diabetes mellitus or peripheral arterial disease. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e001316. doi: 10.1136/bmjdrc-2020-001316.
Clinical trial NCT00190658: Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
Official title: Safety and Efficacy of Humatrope in Pediatric Patients With Genetic Short Stature (SHOX Gene Defect)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Failure to Thrive
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial will compare the mean first year height velocity of somatropin-treated prepubertal patients with SHOX deficiency with the height velocity of a control group of untreated prepubertal patients with SHOX deficiency. Both groups will be compared to a somatropin-treated group of girls with Turner syndrome. After the second year patients in the control group have the option to receive treatment as well. All patients will optionally be treated until they achieved adult height.


Eligibility criteria: Inclusion Criteria:

* Turner Syndrome or SHOX disorder
* SHOX: bone age greater than 10 years for boys, greater than 8 years for girls, Turner: bone age greater than 9 years
* Height below 3rd percentile or height below 10th percentile and growth velocity below 25th percentile
* Prepubertal: For girls, Tanner stage 1, for boys Tanner stage 1 and testicular volume no more than 2 mL

Exclusion Criteria:

* GH deficiency or known insensitivity
* Evidence of tumor activity
* Diabetes mellitus or history of impaired glucose tolerance
* Any severe illness known to interfere growth

Primary outcomes:
measure: Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
Secondary outcomes:
measure: Comparison of second year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
measure: Non inferiority to somatropin treated patients with Turner syndrome
measure: Adult height of treated patients
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Pennsylvania
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_CHAIR
References: