louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00903253: A Double-Blind, Placebo Controlled, Single, Escalating Dose Study to Evaluate the Preliminary Pharmacokinetics, Safety and Tolerability of LNK-754 in Healthy Elderly Volunteers
Official title: A Double-Blind, Placebo Controlled, Single, Escalating Dose Study to Evaluate the Preliminary Pharmacokinetics, Safety and Tolerability of LNK-754 in Healthy Elderly Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Elderly Volunteers
Lead sponsor: Link Medicine Corporation
Sponsor class: INDUSTRY
First posted: 2009-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

Brief summary: The objective of this study is to evaluate the single-dose plasma pharmacokinetics of LNK-754 as well as safety and tolerability in normal healthy male and female elderly volunteers


Eligibility criteria: Inclusion Criteria:

* Males and Females aged 60 to 75 years
* Good general health as determined by medical history and physical examination
* Body Mass Index of 18-32, inclusive
* Estimate of creatinine clearance by Cockcroft-Gault that is normal for age and sex (greater than or equal to 60mL/min)
* Normal hemoccult test at screening and baseline
* Voluntarily consent to participate in the study
* Willing to adhere to the protocol requirements

Exclusion Criteria:

* Subjects with clinically significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurological, sleep disorders by DSM-IV criteria, endocrine, hematological, or metabolic disease as determined by medical history and physical examination
* Subjects who have been diagnosed with or meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV_TR) criteria for any significant psychiatric or psychoactive substance use disorder within the past year
* Subjects with positive urine drug screen or compounds associated with abuse in the absence of medical justification for their presence
* QTcB greater than 450 msec (males), or greater than 470 (females), based on the average interval of triplicate ECGs obtained after five minutes rest in a supine position using hte ECG algorithm
* Clinically significant abnormal screening results or laboratory tests
* Pregnant or nursing or planning a pregnancy, or planning on fathering a child

Primary outcomes:
measure: Plasma Pharmacokinetics
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research
state: Texas
Study officials:
References:
Clinical trial NCT06753253: Effects of Exercise Intensity on ADHD Symptoms
Official title: Effects of Low, Moderate, and High Intensity Exercise on Executive Function, Functional Impairment, and Symptom Severity in ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder with Hyperactivity
Attention Deficit Hyperactivity Disorder
ADHD
Lead sponsor: Kent State University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project investigates the effects of a bicycling exercise at three levels of exercise intensity (low, moderate, and high) on attention deficit/hyperactivity disorder (ADHD) in college students. Specifically, the outcomes of interest in this study are self-reported executive functioning, self-reported functional impairment, and ADHD symptom severity. The hypothesis is that exercise will improve executive functioning, while reducing functional impairment and ADHD symptom severity, and that this response will be most pronounced in the high-intensity exercise group.


Eligibility criteria: Inclusion Criteria:

Diagnosis of attention deficit/hyperactivity disorder (ADHD) Age 18-16 Student at Kent State University

Exclusion Criteria:

seizures/epilepsy syncope asthma chronic obstructive pulmonary disease (COPD) restrictive lung disease adult respiratory distress syndrome (ARDS) heart problems/defects/heart failure/valve problems liver/kidney disease diabetes mellitus current pregnancy

Primary outcomes:
measure: Self-Reported Executive Function
timeFrame: The BDEFS will be assessed on the first day of participation in an exercise intervention (session 1) and again on the last day of the intervention (session 3). Session 1 occurs on a Monday, session 2 on a Wednesday, and Session 3 on a Friday.
measure: Self-Reported Functional Impairment
timeFrame: The BFIS will be assessed on the first day of participation in an exercise intervention (session 1) and again on the last day of the intervention (session 3). Session 1 occurs on a Monday, session 2 on a Wednesday, and Session 3 on a Friday.
measure: Self-Reported ADHD Symptom Severity
timeFrame: The BAARS-IV will be assessed on the first day of participation in an exercise intervention (session 1) and again on the last day of the intervention (session 3). Session 1 occurs on a Monday, session 2 on a Wednesday, and Session 3 on a Friday.
Secondary outcomes:
Other outcomes:
Locations:
city: Kent
country: United States
facility: Kent State University
state: Ohio
Study officials:
References:
Clinical trial NCT03335553: A Study of Experimental Medication BMS-986235 in Healthy Subjects
Official title: Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986235 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mediators of Inflammation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-11-07
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study of experimental medication BMS-986235 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Patients must be normal healthy volunteers as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
* Patients must have a body mass index (BMI) of 18 - 30 mg/kg2, inclusive

Exclusion Criteria:

* Patients that are pregnant
* Patient with any significant acute or chronic medical illness
* Patient with a current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
* Patient with any surgery within 12 weeks of study treatment administration
* Patient with any gastrointestinal surgery that could impact upon the absorption of study drug
* Patient who donated blood to a blood bank or in a clinical study (except a screening visit) within 12 weeks of study drug administration (within 2 weeks for plasma only)
* Patient who received a blood transfusion within 12 weeks of study drug administration

Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of serious adverse events (SAE)
timeFrame: Approximately 30 days
measure: Number of deaths
timeFrame: Approximately 30 days
measure: Number of adverse events (AE) leading to study discontinuation
timeFrame: Approximately 30 days
measure: Number of patients with clinically significant changes in ECG parameters, as defined by the investigator
timeFrame: Approximately 30 days
measure: Number of patients with potentially clinically significant changes in vital signs
timeFrame: Approximately 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05511753: The Effect of Acupuncture on Patients With Noise-induced Hearing Loss
Official title: The Effect of Acupuncture on Patients With Noise-induced Hearing Loss -- Randomized, Single-blinded, Controlled Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Electroacupuncture
Noise Induced Hearing Loss
Hearing Loss, Noise-Induced
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In an era of advanced industry and commerce, working in a noisy environment is one of the most important risk factors for hearing damage, especially among young and middle-aged people. Although acupuncture has been widely used to treat otology-related diseases, such as tinnitus, dizziness, and sudden deafness, there are few studies on the effect of noise-induced hearing loss.

Detailed description: Therefore, the purpose of this study is to investigate the effect of acupuncture on patients with noise-induced hearing loss. This study is designed as a randomized, single-blind, control prospective clinical trial. Eighty subjects with noise-induced hearing loss were included in the criteria and randomly divided into the acupuncture group and the control group as follows: 1) In the acupuncture group, in addition to the conventional treatment, acupuncture on both sides of Baihui (GV20), Dazhui (GV14), Yifeng (TE17), Wangu (GB12), Zhongzhu (TE3), Quchi (LI11), and connecting Yifeng and Wangu, and Zhongzhu and Quchi are given electroacupuncture stimulation (intensity of 1mA, frequency of 2Hz), 3 times a week, 15 minutes each time, continuous 6 weeks; 2) The control group was given conventional treatment only. The main assessment is the hearing changes of the pure tone hearing test, which measure the hearing thresholds of 2KHz, 4KHz, and 8KHz respectively; the secondary assessment is the change of the tinnitus handicap index score. The evaluation time includes before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after the end of acupuncture treatment.

The results of this study are expected to prove that acupuncture can improve noise-induced hearing loss.

Eligibility criteria: Inclusion Criteria:

* pure tone audiometry diagnosed noise-induced hearing loss
* age: 20 - 65

Exclusion Criteria:

* major medical disease -- cancer, renal disease
* pregnancy or milk women
* anti-coagulation use
* pacemaker use
* allergy to needle
* denied accept inform consent

Primary outcomes:
measure: pure tone audiometry observe changes in hearing
timeFrame: Before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after acupuncture treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01319253: A Comparator Study Evaluating Microbiological Resistance and Effects of Alternating Inhaled Antibiotic Therapies
Official title: Comparator Trial Evaluating Microbiological Resistance and Clinical Efficacy in Patients Using Alternation Therapy of Inhaled Antibiotics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Pseudomonas Aeruginosa
Keywords: Cystic Fibrosis
Pseudomonas aeruginosa
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2011-03-21
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: This is a pilot study of inhaled antibiotic regimens is a pilot study examining clinical and laboratory endpoints of patients on inhaled antibiotic treatments. We hypothesize that alternation therapy utilizing Cayston and Tobi will inhibit antibiotic resistance and that alternation therapy will result in a decreased incidence of antibiotic resistance to Cystic Fibrosis (CF) microbial isolates. The long term strategic goal is to develop a model biometric system for selecting a patient's optimal inhaled antibiotic regimen by utilizing clinical and microbiological parameters.


Eligibility criteria: Inclusion Criteria:

* \> or = to 6 years of age
* Documentation of Cf diagnosis
* History of PA present in sputum, on a least one occasion, during the 12 months prior to Visit 1.
* Currently on inhaled antibiotic regiment
* Must be able to provide written informed consent or assent prior to any study related procedures
* Ability to expectorate sputum
* Ability ro perform reproducible pulmonary function test

Exclusion Criteria:

* Administration of any IV or oral antipseudomonal antibiotic within 28 days prior to Visit 1
* Any serious or active medical or psychiatric illness, which in the opinion of the investigator, woud interfere with participant treatment, assessment, or compliance with the protocol
* Current enrollment in an interventional clinical trial

Primary outcomes:
measure: Antibiotic Resistance Profiles
timeFrame: Every three months within a 12 month period
Secondary outcomes:
measure: Clinical Symptoms
timeFrame: Every 3 months within a 12 month period
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Michelle S Howenstine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Gregory Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03686553: St. Barbara Specialised Regional Hospital No. 5: Surveillance of Healthcare-Associated Infections
Official title: St. Barbara Specialised Regional Hospital No. 5: Surveillance of Healthcare-Associated Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infections
Lead sponsor: Polskie Towarzystwo Zakażeń Szpitalnych
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 5239
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing surgery in the Orthopaedic and Trauma Surgery Unit in Sosnowiec, Poland

Brief summary: Retrospective laboratory-based data collection study of surgical site infections: Surveillance of Healthcare-Associated Infections in Orthopaedic and Trauma Surgery Unit in Sosnowiec, Poland;


Eligibility criteria: Inclusion Criteria:

* patient being treated in the Department and Clinic of Orthopaedic and Trauma Surgery, St. Barbara Specialised Regional Hospital No. 5, Sosnowiec
* patients undergoing surgery in studied unit

Exclusion Criteria:

* under 18 years of age
* surgery of a different type than orthopedics
* non-surgical treatment

Primary outcomes:
measure: surgical site infection incidence rate
timeFrame: The follow-up period was 30 days for the superficial SSI's, and 90 days for deep or organ/space infections following arthroplasties
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02854553: TAP Block Alone Versus TAPblock With Rectus Sheath Block in Liposuction Surgery
Official title: Transversus Abdominis Plane Block Alone Versus Transversus Abdominis Plane Block With Rectus Sheath Block as a Postoperative Analgesia in Anterior Abdominal Wall Liposuction Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 48
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 transversus abdominis plane (TAP) block is an effective regional nerve block for the anterior abdominal wall. An anesthesiologist typically administers the TAP block preoperatively with ultrasound guidance. It is not yet commonly used during anterior abdominal wall liposuction, where postprocedural pain remains a major concern for patients and surgeons.

Detailed description: The author investigated the feasibility of administering the TAP block under direct vision and compared postoperative narcotic use in patients who received analgesia by TAP block vs with TAP block i addition to rectus sheath block, both performed under direct vision during anterior abdominal wall liposuction.

Eligibility criteria: Inclusion Criteria:

* ASA I-II, consent,

Exclusion Criteria:

* allergy, coagulopathy, refusal, mentally unstable

Primary outcomes:
measure: pain
timeFrame: Three days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
References:
Clinical trial NCT00147953: Study to Evaluate the Efficacy of Rituximab in Combination With Low-dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma
Official title: A Phase II Study of Rituximab Plus Low-Dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: NHL
Lymphoma
Radiotherapy
Rituximab
Palliative treatment
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2005-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

Detailed description: Rituximab and low-dose total-nodal irradiation both have shown promising activity in patients with NHL. Moreover, the radiolabelled antibody Zevalin has been approved for the treatment of relapsed NHL. The patients in this study have a poor prognosis. The treatment strategy aims to control the disease and to ameliorate disease related symptoms with minimal toxicity. Both, rituximab and low-dose radiotherapy are associated with minor toxicity if applied alone.

The primary objective of the study is therefore to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

Eligibility criteria: Inclusion Criteria:

* B-cell non-Hodgkin's lymphoma
* At least one prior antitumor therapy
* ECOG performance status 0-2
* No major organ dysfunction
* Written informed consent

Exclusion Criteria:

* The following histologies are excluded: Burkitt's lymphoma, mantle-cell lymphoma, primary CNS-lymphoma, HIV-associated lymphoma

Primary outcomes:
measure: Overall response rate (complete and partial response rate)
Secondary outcomes:
measure: Toxicity
measure: Time to progression
measure: Response duration
measure: Quality-of-Life
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne
state: NRW
Study officials:
affiliation: University of Cologne
name: Andreas Engert
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cologne
name: R.-P. Mueller
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03828253: Ellipsys Fistula for Hemodialysis Access
Official title: Ellipsys Percutaneous Arteriovenous Fistula for Hemodialysis Access
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ESRD
Lead sponsor: Richmond Vascular Center
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment of subjects will be from the current End Stage Renal disease patient population at Richmond Vascular Center and referrals from Nephrologists and Vascular Surgeons.

The study would like to enroll up to 100 patients without age, gender-based, race and ethnicity enrollment restrictions for adults over 18 years of age. Women of child bearing potential are not excluded. If a pregnant patient required, an arteriovenous fistula for hemodialysis an Ellipsys® fistula would be an option. We would like to consent previous Ellipsys® patients with appropriate medical records so that we may capture their data for outcomes reporting.

Brief summary: To report the outcomes of patients having percutaneous proximal radial artery fistula creation.

Detailed description: The study would like to enroll up to 100 patients without age, gender-based, race and ethnicity enrollment restrictions for adults over 18 years of age. Women of child bearing potential are not excluded. If a pregnant patient required, an arteriovenous fistula for hemodialysis an Ellipsys® fistula would be an option. The Investigator would like to consent previous Ellipsys® patients with appropriate medical records so that the Investigator may capture participants data for outcomes reporting.

Eligibility criteria: Inclusion Criteria:

* Patient age \> 18 years or older
* Diagnosed with ESRD or chronic kidney disease requiring dialysis or anticipating start of dialysis
* Adjacent vein diameter of \> 2.0 mm at target anastomosis site and confirmed clinically significant outflow
* Arterial lumen diameter of \> 2.0 mm at target anastomosis site
* Adequate collateral arterial perfusion: Barbeau test grade A through C
* Radial artery -adjacent vein proximity \< 1.5 mm measured lumen edge-to-lumen edge via ultrasound

Exclusion Criteria:

* Target vessel that are \< 2mm is diameter
* Distance between the target artery and vein \> 1.5 mm
* Edema of the upper extremity on the ipsilateral side
* Barbeau test grade D

Primary outcomes:
measure: Blood flow Volume
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: North Chesterfield
country: United States
facility: Richmond Vascular Center
state: Virginia
Study officials:
affiliation: Richmond Vascular Center
name: Jeffrey Hull, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hull J, Deitrick J, Groome K. Maturation for Hemodialysis in the Ellipsys Post-Market Registry. J Vasc Interv Radiol. 2020 Sep;31(9):1373-1381. doi: 10.1016/j.jvir.2020.03.001. Epub 2020 Aug 14.
Clinical trial NCT01190553: Pilot Study of Maintenance Therapy With Intravenous AMANTADINE
Official title: Maintenance Therapy of Intravenous Amantadine in Patients With Idiopathic Parkinson Disease Who Are Not Optimally Treated With Anti Parkinson Medications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: amantadine
parkinson disease
dyskinesia
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2010-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study for Maintenance Intravenous Treatment with AMANTADINE in patient with PARKINSON'S Disease who are not well balanced with medical treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic Parkinson disease
* Age\<80
* Patients with no motor improvement under optimal treatment with anti parkinson medications
* Patients with moderate to severe dyskinesias
* Patients with PD with side effects who can not tolerate anti parkinson medications

Exclusion Criteria:

* Age\>80
* Patients with Parkinson syndromes, vascular parkinsonism or drug-induced parkinsonism
* Patients with PD who developed adverse reactions to oral amantadine
* Contraindication of amantadine treatment

Primary outcomes:
measure: Improvement of UPDRS scores after 6 months of treatment
timeFrame: 6 months
measure: Improvement of dyskinesias score.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: