louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01468636: A RTC to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts
Official title: A Randomized Controlled Trial to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Genital Warts
HPV
Keywords: Warts
HPV
Zinc
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: British Columbia Centre for Disease Control
First posted: 2011-11-09
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effect of 400 mg of oral zinc gluconate on genital warts. Our hypothesis is that there will be a 10% difference in complete clearance of genital warts in the group randomized to oral plus standard of care compared to those randomized to placebo plus standard of care.

Detailed description: Clients presenting to the BCCDC STI clinic with genital warts will be randomized to either 400 mg zinc gluconate or placebo (200mg BID) for 8 weeks in addition to the standard of care. Clinical assessment of warts and additional standard treatment will occur every 7-10 days for a maximum of 8 weeks. A telephone call will occur at week 20 to determine if any of the warts have cleared or re-appeared. The appearance of new warts will also be noted. The proportion of subjects who have complete clearance of genital warts at 8 weeks will be compared between groups.

Eligibility criteria: Inclusion Criteria:

1. Adults age 19 and over
2. Clinical diagnosis of genital warts requiring treatment based on clinician evaluation
3. Fluency in English
4. Available within four days of the intended 8 week follow-up visit

Exclusion Criteria:

1. Individuals under the age of 19
2. Pregnant women
3. Known contraindication to zinc Signs of copper/iron deficiency which include anemia and neutropenia which are characterized by tiredness, fatigue and light headedness.
4. Diseases that alter zinc metabolism or absorption eg. type II diabetes mellitus, Crohn's disease, chronic leg ulcers
5. Clients who are currently taking zinc for therapeutic purposes or have taken zinc in the last two months for therapeutic purposes
6. Clients who have received standard of care treatment for their warts in the past month

Primary outcomes:
measure: complete clearance of genital warts
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Centre for Disease Control
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Richard Lester
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04092036: Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness
Official title: Prospective Study: Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fluid Responsiveness
Optic Nerve Sheath Diameter
Shock
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tanta University Hospitals at the surgical intensive care unit

Brief summary: The aim of the study to examine Optic Nerve Sheath Diameter measurement for prediction of fluid responsiveness in hemodynamically unstable patients


Eligibility criteria: Inclusion Criteria:

* Patients on mechanical ventilation
* 18 years or older
* patients developing hypotension (Mean arterial blood pressure) \<65 mmHg

Exclusion Criteria:

* Patients with Spontaneously breathing activity.
* Patients with a history of intracranial disease e.g. (stroke, TBI, causes of increased intracranial pressure).
* local cause in the eye as (Glaucoma, Single eye)
* Need for high PEEP.
* Known history of cardiac disease.
* Organ/s failure at admission

Primary outcomes:
measure: The cut-off value of optic nerve sheath diameter (ONSD) for prediction of fluid responsiveness
timeFrame: first day
Secondary outcomes:
measure: Correlation between Stroke Volume Variation (by electrical cardiometry) and ONSD
timeFrame: first day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02971436: Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2016-11-23
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure delivery will also be evaluated. The FPH device will be compared to a market released product.


Eligibility criteria: Inclusion Criteria:

* Aged 18 and over
* Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) - (Continuous Positive Airway Pressure (CPAP) or AutoCPAP). Participants can be naïve to CPAP or experienced users of CPAP.
* For experienced users of PAP (CPAP or AutoCPAP): Using the PAP of more than 4 hours/night for 70% during the last 30 days (justification allowed by the investigator)

Exclusion Criteria:

* Contraindicated for PAP (CPAP or AutoCPAP) therapy
* Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea)
* Persons with obesity hypoventilation syndrome or congestive heart failure.
* Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device
* Persons with implanted electronic medical device (e.g cardiac pacemakers)
* Persons who are pregnant or think they might be pregnant.

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: 3 nights
measure: Apnea Hypopnea Index (AHI)
timeFrame: 1 night
Secondary outcomes:
measure: Therapy Comfort
timeFrame: 3 nights
measure: Compliance
timeFrame: 3 nights
measure: Device Triggering
timeFrame: 3 nights
measure: Device Triggering
timeFrame: 1 night
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare
city: Wellington
country: New Zealand
facility: WellSleep Centre
Study officials:
References:
Clinical trial NCT00999336: A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
Official title: Pharmacokinetics, Pharmacodynamics, and Tolerability of Betrixaban Administered Orally in Subjects With Normal and Reduced Renal Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: Betrixaban
Renal impairment
Healthy
Kidney dysfunction
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-10-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Able to understand and sign the written informed consent.
* Subjects should have either normal renal function or have stable renal disease

Exclusion Criteria:

* Subjects require dialysis
* Evidence of active bleeding or bleeding disorder
* Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder

Primary outcomes:
measure: Area Under The Plasma Concentration-Time Curve From Time Zero To 24 Hours (AUC0-24) Postdose Of Oral Doses Of Betrixaban On Day 8
timeFrame: Predose up to 168 hours postdose
measure: Maximum Observed Plasma Concentration (Cmax) Following Administration Of Oral Doses Of Betrixaban On Day 8
timeFrame: Predose, up to 168 hours postdose
measure: Plasma Terminal Elimination Half-Life (T½) Following Administration Of Oral Doses Of Betrixaban On Day 8
timeFrame: Predose, up to 168 hours postdose
measure: Total Plasma Clearance (CL/F) Following Administration Of Oral Doses Of Betrixaban On Day 8
timeFrame: Predose, up to 168 hours postdose
measure: Volume Of Distribution During The Terminal Phase (Vz/F) Following Administration Of Oral Doses Of Betrixaban On Day 8
timeFrame: Predose, up to 168 hours postdose
measure: Percentage Of Dose Excreted In Urine From 0-24 (fe0-24) Postdose Of Oral Doses Of Betrixaban On Day 8
timeFrame: Predose, up to 24 hours postdose
measure: Percentage Of Betrixaban Bound To Plasma Proteins On Day 8
timeFrame: 4 hours Postdose at Day 8
measure: Thrombin Generation Following Administration Of Oral Doses Of Betrixaban On Day 8
timeFrame: Day 1: predose; Day 8: 2, 3, 4, 8, 24, and 48 hours postdose
measure: Anti-Factor Xa (fXa) Activity Following Administration Of Oral Doses Of Betrixaban On Day 8
timeFrame: Day 8: 2, 3, 4, 8, 24, and 48 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: APEX GmbH
Study officials:
References:
Clinical trial NCT02127736: Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin
Official title: Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2014-05-01
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to evaluate whether an Amitriptylin induced change in sleep patterns can be conditioned according to learning theory in healthy participants.


Eligibility criteria: Inclusion Criteria:

* age between 18 years to 69 years
* willingness to refrain from alcohol consumption throughout the study
* regular sleeping habits
* fluent in German language
* is not dependent on driving to get to the study center
* provide written informed consent
* ability to understand the explanations and instructions given by the study physician and the investigator

Exclusion Criteria:

* Contraindications to study medication intake according to the information sheet for health professionals (Summary of medicinal Product Characteristics, SmPC) assessed by physical examination (including ECG) and medical history

  * allergies to amitriptyline hydrochloride or any of its ingredients
  * acute intoxication with alcohol, analgetics, hypnotics or any other psychotropic drug
  * urinary retention
  * delirium
  * untreated closed-angle glaucoma
  * prostatic hyperplasia
  * pyloric stenosis
  * paralytic ileus
  * suicidal thoughts
  * liver/ kidney/ pulmonary insufficiency
  * myasthenia gravis
  * hypokalemia
  * bradycardia
  * coronary heart disease, cardiac arrhythmias, long QT syndrome or other clinically relevant cardiac disorders
  * increased risk of seizures/ history of seizures
  * substance dependence syndrome/ history of substance dependence syndrome
* Allergies to ingredients of placebo or novel-tasting drink (CS)
* currently pregnant (verified by urine pregnancy test) or lactating
* patients suffering from a mental disorder as verified by the International Diagnosis Checklists (IDCL)
* patients suffering from a medical condition (assessed by the study physician)
* Concomitant medication interfering with study medication intake due to potential interactions
* participation in any other clinical trial 3 months prior to visit 1
* employee of the Sponsor or the principal investigator

Primary outcomes:
measure: Objective Total Sleep Time
timeFrame: 5 nights during the study
measure: Percentage of rapid eye movement (REM) sleep
timeFrame: 5 nights during the study
Secondary outcomes:
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Department of Psychology, Philipps University Marburg
state: Hessen
Study officials:
References:
citation: Rheker J, Rief W, Doering BK, Winkler A. Assessment of adverse events in clinical drug trials: Identifying amitriptyline's placebo- and baseline-controlled side effects. Exp Clin Psychopharmacol. 2018 Jun;26(3):320-326. doi: 10.1037/pha0000194.
Clinical trial NCT03865836: Expanded Access for ATB200/AT2221 for the Treatment of Pompe Disease
Official title: Named Patient or Compassionate Use for Treatment Use of ATB200/AT2221 for Patients With Pompe Disease
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Pompe Disease
Keywords: expanded access
compassionate use
Lead sponsor: Amicus Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-03-07
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) for eligible participants designed to provide access to ATB200/AT2221.

Detailed description: This program is being offered on a patient by patient basis and will require company, IRB/IEC and single patient IND approval.

Eligibility criteria: Inclusion Criteria:

1. Subject must have a diagnosis of Pompe disease based on documentation of one of the following:

   1. deficiency of GAA enzyme
   2. GAA genotyping
2. Patient does not currently qualify for an Amicus sponsored on-going clinical trial or is declining on currently approved ERT (e.g. Myozyme)
3. The patient must be willing to receive treatment with ATB200/AT2221 via this program, which includes signing an authorization form for sharing clinical data with Amicus Therapeutics, and its agent Early Access Care LLC.

Exclusion Criteria:

1. Patient, whether male or female, is planning to conceive a child during the treatment program.
2. Patient has a hypersensitivity to any of the excipients in ATB200, alglucosidase alfa, or AT2221
3. Patient has a medical or any other extenuating condition or circumstance that may, in the opinion of the investigator, pose an undue safety risk to the subject or compromise his/her ability to comply with or adversely impact protocol requirements.
4. Patient has received any gene therapy at any time.
5. Concomitant use of miglitol (eg, Glyset), non-AT2221 form of miglustat (eg, Zavesca), acarbose (eg, Precose or Glucobay), voglibose (eg, Volix, Vocarb, or Volibo)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00819936: A Controlled Trial of Effectiveness of a Backward Walking Program in Patients Recovering From Abdominal Aorta Surgery
Official title: A Controlled Trial of Effectiveness of a Backward Walking Program in Patients Recovering From an Abdominal Aorta Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Surgery
Keywords: abdominal aorta surgery
Physical Training
backward walking
physiotherapy
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2009-01-09
Enrollment: 47
Sex: MALE
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Summary Question: Does backward walking offer additional therapeutic value in patients after aortic aneurysm surgery? Participants: The study of backward walking as an addictive physiotherapy procedure was conducted in the group of 65 patients who underwent abdominal aorta surgery. The patients were randomly divided into three subgroups and three various models of physiotherapy were applied. Control group has only routine physiotherapy since therapeutic group I and II have also walking exercises forward in group I and backward in group II respectively.


Eligibility criteria: Inclusion Criteria:

* Patients with abdominal aortic aneurysm
* Age 65-75 years
* Male sex
* Stable cardiologic status
* Absence of neurological disorders
* Non-symptomatic aneurysm - non-ruptured
* No pain complaints
* No motion system impairments

Exclusion Criteria:

* Patients with neurological disorders
* Unstable coronary heart disease symptomatic aortic aneurysm - dissecans aneurysm
* Having difficulty in locomotion
* Having contradiction for starting physical training during the first or second day after surgery
* Patients with psychiatric disease
* Lack of patient's compliance with physiotherapist; AND
* Other medical contraindications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06976736: A Long Term Follow-up Study of TScan TCR-T Products
Official title: A Long-term Follow-up Study to Assess Safety in Participants Who Received an Investigational T-Cell Receptor Engineered T-Cell (TCR-T) Product
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: AML
ALL
MDS
Keywords: TSCAN
Cell Therapies
TCR-T Cell Therapy
Long Term Follow-Up (LTFU)
TSC-101
TSC-100
TSCAN-001
Lead sponsor: TScan Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who received TSC-100 or TSC-101 cellular therapies.

Brief summary: The purpose of this Long-Term Follow-Up (LTFU) study is to monitor participants who have previously received TSC-100 or TSC-101 TCR-T therapies in the TSCAN-001 study. Participants will be monitored for 15 years from the date of TCR-T cell therapy administration to assess long-term safety and efficacy.

Detailed description: Participants will enroll in this LTFU study after completing the TSCAN-001 interventional trial. No additional study drug will be administered; however, participants may receive other cancer treatments as needed while being monitored for long-term safety.

Enrollment will occur after completion of the TSCAN-001 study, and participants will be monitored for safety and efficacy over a 15 year period.

Eligibility criteria: Inclusion Criteria:

* Participants who received a TCR-T cellular therapy in a clinical study sponsored by TScan Therapeutics.
* Signed informed consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: 15 years post TCR-T administration
Secondary outcomes:
measure: Overall Survival
timeFrame: 15 years post TCR-T administration
measure: Relapse-free survival
timeFrame: 15 years post TCR-T administration
measure: Progression-free survival
timeFrame: 15 years post TCR-T administration
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: New York
country: United States
facility: Mount Sinai
state: New York
Study officials:
affiliation: Medical Monitor
name: Michelle Matzko, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00309036: Safety and Efficacy of Recombinant Grass Pollen Allergen Cocktail in the Treatment of Allergic Rhinoconjunctivitis
Official title: A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-adsorbed Cocktail of Recombinant Derivatives of Major Allergens of Timothy Grass (Phleum Pratense).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Keywords: Allergy
Grass pollen
Recombinant
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2006-03-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial is performed to assess efficacy and safety of a recombinant grass Pollen allergen cocktail in allergic rhinoconjunctivitis


Eligibility criteria: Inclusion Criteria:

* Positive Skin Prick Test reaction to grass pollen
* Positive RAST result to grass pollen
* Positive Provocation Test result to grass pollen

Exclusion Criteria:

* Serious chronic diseases
* Other relevant perennial allergies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Reinbek
country: Germany
facility: Allergopharma GmbH & Co. KG
Study officials:
name: Annemie Narkus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05581836: The Effect of Central Sensitization and Neuropathic Pain After Total Knee Arthroplasty
Official title: The Effect of Central Sensitization and Neuropathic Pain on Patients Reported Outcomes Following Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 312
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was approved by the Institutional Review Board of our hospital. Between May 2019 and February 2020, a total of 332 primary TKAs were performed at our institution by a single surgeon. Only patients with a follow-up period of more than two years were included in the study. The remaining 316 patients with primary TKAs were enrolled in this study.

Brief summary: It has been well known that central sensitization (CS) is a risk factor for inferior outcomes following total knee arthroplasty (TKA). However, there are still insufficient studies on the relationship between CS and neuropathic pain (NP), and the effects of CS and NP on the patient-reported outcome measures (PROMs) of patients who underwent TKA. The purpose of this study was to investigate the relationship between CS and NP and whether CS and NP were associated with PROM in patients undergoing TKA.

Detailed description: A total of 312 patients who underwent primary TKA for end stage knee OA were enrolled. CS was defined as a patient with a score of 40 or higher using central sensitization inventory (CSI). NP was defined as a patient with a score of 12 or more using pain detect questionnaire (PDQ). PROMs were also evaluated based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score preoperatively and at postoperative 1 year. The patients were divided into 4 groups, group 1 with CS and NP positive, group 2 with only CS positive, group 3 with only NP positive, and group 4 with CS and NP negative, and PROM was compared between the groups.

Eligibility criteria: Inclusion Criteria:

* Primary knee degenerative osteoarthritis
* Patients for total knee arthroplasty over the age of 60
* Patients with 2 year postoperative medical records

Exclusion Criteria:

* Rheumatoid arthritis
* Other inflammatory arthritis
* Neuropsychiatric patients
* Hepatic insufficiency
* Renal insufficiency
* Allergy or intolerance to study medications
* Patients with an acetylsalicylic acid of IV (angina, congestive heart failure, dementia, cerebrovascular accident)
* Chronic opioid use (taking opioids for longer than 3 months)
* Alcohol, drug abuser
* Narcotics addiction

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
timeFrame: 2 years after TKA
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic Univerisity of Korea Seoul St Mary's hospital
Study officials:
References: