louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04802928: Healing of Ischemic Leg Ulcers in Patients Treated With iSONIAzid
Official title: Healing of Ischemic Leg Ulcers: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Arterial Leg Ulcer
Lead sponsor: Pharma 2100
Sponsor class: INDUSTRY
First posted: 2021-03-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to study the healing effect of an oral drug (isoniazid) in patients with ischemic (arterial) leg ulcers defined by a systolic toe pressure \<40 mm Hg.

Detailed description: Treatment of arterial ulcers is problematic. Previous pharmaceutical interventions with for example prostaglandins have produced only limited beneficial effects but have been associated with frequent adverse effects. Positive effects of isoniazid have been observed in a preclinical model of ischemic wound healing (Weinreich et al. Surgery 2010).

Eligibility criteria: Inclusion Criteria:

* Patients with ischemic leg ulcers unsuitable for vascular surgical intervention
* Systolic toe pressure \< 40 mm Hg
* Ulcer duration \> 3 months
* Ulcer area: 1-20 cm2
* Written informed consent

Exclusion Criteria:

* B-Hb \< 6 mmol/l
* Aspartate transaminase \> 50 U/l
* Diabetes mellitus \> 10%HbA1c
* Usage of more than 10 mg prednisolone daily within the last 30 days
* Usage of cytotoxic agents with the last 3 months
* Usage of rifampicin, phenytoin, carbamazepin, theophylline, benzodiazepines (diazepam, triazolam), stavudine and/or valproat
* Alcohol abuse
* Hereditary galactose intolerance
* Hypersensitive to isoniazid or for one or more of the filling substances (magnesium stearate, povidone, talcum, lactose and starch)
* Cellulitis or deep infection (osteomyelitis and/or tendonitis) related to the ulcer
* Gangrene
* Participation in clinical trials within the last 7 days
* Pregnancy or breastfeeding
* Women of child bearing potential who decline to use contraception

Primary outcomes:
measure: The percentage change of ulcer area 8 weeks after initiation of therapy.
timeFrame: 8 weeks
Secondary outcomes:
measure: Pain is evaluated by visual analogue scale (VAS).
timeFrame: 8 weeks
measure: Occurrence of suspected unexpected serious adverse reactions (SUSAR) and serious adverse events (SAE)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital, Copenhagen, Denmark
name: Tonny Karlsmark, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01062061: Re-examination Study For Varivax (V210-059 AM2)
Official title: Re-examination Study for General Vaccine Use to Assess the Safety Profile of Varivax in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicella
Keywords: Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-04
Enrollment: 754
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean participants being vaccinated with VARIVAX in usual practice

Brief summary: This survey is conducted for preparing application materials for re-examination under the Korean Pharmaceutical Affairs Laws and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of VARIVAX through collecting the safety information according to the Re-examination Regulation for New Drugs.

Detailed description: This post-marketing survey was conducted in the usual routine practice and the investigator enrolled participants vaccinated with VARIVAX continuously after study start. The purpose of the study was to assess the occurrence of adverse events and to identify factors that may affect the safety of the vaccine under real-life, post-marketing conditions. No hypothesis testing was conducted in this survey.

Eligibility criteria: Inclusion Criteria:

* Participants must be vaccinated with VARIVAX as a standard of care

Exclusion Criteria:

* Participants who have been previously vaccinated with VARIVAX
* Contraindication with VARIVAX

Primary outcomes:
measure: Percentage of Participants With One or More Adverse Events (AEs)
timeFrame: Up to 42 days after vaccination
measure: Percentage of Participants With One or More AEs by Gender
timeFrame: Up to 42 days after vaccination
measure: Percentage of Participants With One or More AEs by Age
timeFrame: Up to 42 days after vaccination
measure: Percentage of Participants With One or More Adverse Drug Reactions (ADRs)
timeFrame: Up to 42 days after vaccination
measure: Percentage of Participants With One or More Unexpected AEs
timeFrame: Up to 42 days after vaccination
measure: Percentage of Participants With One or More Unexpected ADRs
timeFrame: Up to 42 days after vaccination
measure: Percentage of Participants With One or More Serious Adverse Events (SAEs)
timeFrame: Up to 42 days after vaccination
measure: Percentage of Participants With One or More Serious ADRs
timeFrame: Up to 42 days after vaccination
measure: Percentage of Participants With One or More Unexpected SAEs
timeFrame: Up to 42 days after vaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06847061: Pulmonary Rehabilitation for Rural Patients With COPD
Official title: Decreasing Disparity in Lung Disease: Pulmonary Rehabilitation for Rural Patients With COPD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2025-02-26
Enrollment: 306
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study design is control/Wait.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test the uptake, effectiveness, and patient-caregiver-provider experience of a crucial treatment not provided in rural areas: pulmonary rehabilitation.


Eligibility criteria: Inclusion Criteria

* 40 years of age or older
* Physician-diagnosed COPD
* Living in a rural area defined by Rural-Urban Commuting Area Codes 4-10
* mMRC score\>=1
* English Speaking

Exclusion Criteria

* Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility)
* Cognitive impairment or inability to understand and follow instructions.
* Patients with no COPD symptom burden, no breathlessness (mMRC score 0), as based on our previous studies they usually perceive no benefit from PR and do not have compliance with PR.
* Traditional center-based PR was completed within 3 months of initial study recruitment.
* Transition to hospice or end-of-life care at the time of screening.
* Acute exacerbation at the time of screening.

Primary outcomes:
measure: Change Chronic Respiratory Questionnaire Physical and Emotional (CRQ-SAS) summary scores
timeFrame: Baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto Benzo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Teng Moua, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05619861: CAR-T Cells in the Treatment of Malignant Hematological Tumors
Official title: Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma, B-Cell
Leukemia, B-cell
Leukemia, T-Cell
Multiple Myeloma
Keywords: T cells
Lead sponsor: Hebei Senlang Biotechnology Inc., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Cangzhou People's Hospital
First posted: 2022-11-17
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

Detailed description: Main research objective: To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors. Secondary research objective: To investigate the efficacy and cytodynamic characteristics of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

Eligibility criteria: 1. With the consent of himself or the legal guardian and the signed informed consent, he is willing and able to comply with the planned visit, research and treatment, laboratory examination and other test procedures; Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor
2. Patients with recurrent and refractory hematopoiesis and lymphoid tissue tumors determined by clinical diagnosis;
3. Age 14-70 (including boundary value), both male and female;
4. Subjects with a physical status of 0\~2 in the American Eastern Oncology Collaboration Group (ECOG);
5. The results of treatment related antigens were positive;
6. The expected life span is more than 3 months from the date of signing the informed consent;

Primary outcomes:
measure: Safety: Incidence and severity of adverse events
timeFrame: 24 months post CAR-T cells infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Cangzhou
country: China
facility: Cangzhou People's Hospital
state: Hebei
Study officials:
References:
Clinical trial NCT02974361: Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen
Official title: An Open-label, Single-dose, Randomised, Crossover Study to Evaluate Changes in the Pharmacokinetics of Ibuprofen From Ibuprofen-LDH Dosed With and Without Release Modifying Excipients in Normal, Healthy, Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Oxford Pharmascience Ltd
Sponsor class: INDUSTRY
First posted: 2016-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH. Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new version of ibuprofen is expected to produce fewer stomach/intestine related side effects when compared to many existing marketed formulations of Ibuprofen.

This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way crossover and Part C is a maximum of a 4 way crossover. The size of Parts B \& Part C and allocated interventions will be confirmed after review of data from Parts A and/or B respectively.

A total of 30 subjects will take part in the study; 10 per study part.

The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and without a selection of different excipients. The pharmacokinetic properties will include how quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug that reaches the bloodstream.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects
* BMI 18 - 30 kg/m2
* Willing and able to provide written informed consent

Exclusion Criteria:

* Evidence or history of significant renal, hepatic, gastrointestinal, central nervous system, respiratory, cardiovascular, autoimmune or metabolic dysfunction
* Recent or concurrent use of prescription or non-prescription medications, other than contraceptives
* Allergy or sensitivity to NSAIDs

Primary outcomes:
measure: Cmax
timeFrame: 12 hours
measure: AUC(0-inf)
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec Orion Ltd
Study officials:
affiliation: Simbec Orion Ltd
name: Annelize Koch
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03230461: Estimation of CPR Chest Compression Depth
Official title: Can Rescuers Accurately Deliver Subtle Changes to Chest Compression Depth if Recommended by Future Guidelines?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: CPR
Basic life support
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Southampton
First posted: 2017-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective, randomised.
Primary purpose: TREATMENT

Brief summary: Optimal chest compression depth during CPR is 4.56cm which is at variance with the current guidelines of 5.0-6.0cm. A change in guidelines is only worthwhile if healthcare professionals can accurately judge a subtle reduction in chest compression depth during CPR by a relatively small amount.

Detailed description: Chest compression depth and rate during cardiopulmonary resuscitation (CPR) are important predictors of return of spontaneous circulation and survival following cardiac arrest. Stiell et al (2014) found optimal survival at a compression depth of 4.56cm, which is at variance with the current guidelines of 5.0-6.0cm. A change in guidelines is only likely to improve survival rates if healthcare professionals can accurately implement these subtle depth modifications into the basic life support (BLS) algorithm. This study aims to determine if healthcare professionals can accurately judge compression depth without real-time feedback.

Eligibility criteria: Inclusion Criteria:

* NHS professionals (staff or students), who have successfully completed a hospital-accredited basic life support (BLS) course, including a practical CPR component.

Exclusion Criteria:

* Pregnancy, significant medical illness or injury that would impair delivery of chest compressions

Primary outcomes:
measure: Compression to target window depth
timeFrame: Two minutes
Secondary outcomes:
measure: Compression to target rate
timeFrame: Two minutes
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
state: Hampshire
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Charles Deakin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02120261: Using Saline for Myofascial Pain Syndromes (USAMPS)
Official title: Using Saline for Myofascial Pain Syndromes (USAMPS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Myofascial Pain Syndrome
Keywords: Myofascial Pain Syndrome
trigger point injection
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study involves adult patients diagnosed with Myofascial Pain Syndromes (MPS). The purpose of this research study is to determine if there is a therapeutic difference between trigger point injection (TPI) of normal saline and conventional drug mix (local anesthesic + steroid) in treating MPS.


Eligibility criteria: Inclusion Criteria:

* Adult patients diagnosed with MPS of the trapezius, gluteus medius/minimus, iliocostalis thoracis-lumborum, quadratus Lumborum, or paraspinal muscles in the emergency department.

Exclusion Criteria:

* Patients allergic to lidocaine and/or steroids.
* Pregnant women.
* Prisoners.
* Patients who are cognitively impaired and/or unable to consent for the study.
* Age \< 18.
* Signs of localized infection or skin breakdown at the injection site.

Primary outcomes:
measure: Pain Intensity
timeFrame: baseline
measure: Pain Intensity
timeFrame: at discharge (a few minutes after receiving intervention)
measure: Pain Intensity
timeFrame: 2 weeks
Secondary outcomes:
measure: Duration of Pain Relief
timeFrame: 16 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon Baines Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital Texas Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Carlos Roldan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01336361: Emerging Physical Therapy Practice in Palliative Care: A Survey of Perceptions of Physical Therapists
Official title: Emerging Practice in Palliative Care: A Survey of the Perceptions of Physical Therapists Regarding the Role, Utilization, Goals, and Cultural Issues of Physical Therapy Intervention in the Palliative Care of Functionally Dependent Elderly.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perception
Keywords: Palliative Care
Physical Therapy
Functionally Dependent Elderly
Lead sponsor: University of Montana
Sponsor class: OTHER
First posted: 2011-04-15
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Physical Therapists who are members of the APTA and live in the United States.

Brief summary: The purpose of this study is to explore emerging physical therapy practice in palliative care, and the perceptions of physical therapists regarding their care of the functionally dependent elderly, including: (1) the role and utilization of palliative care intervention in current practice, (2) current and potential goal-setting practices which may relate to palliative care, and (3) therapists' awareness of cultural and psychosocial issues in patient care.

Detailed description: Palliative Care is a growing medical practice specialty, however the level of physical therapist involvement and the particular roles for physical therapy in this evolving discipline are relatively unknown.

The purpose of this study was to explore emerging physical therapy practice in palliative care, and the perceptions of physical therapists regarding their care of the functionally dependent elderly, including the role and utilization of palliative care intervention in current practice, goal-setting practices which may relate to palliative care, and therapists' awareness of cultural and psychosocial issues in patient care.

Eligibility criteria: Inclusion Criteria:

* Physical Therapists who are members of the APTA and live in the United States
* Reported practice in an inpatient or home health setting

Exclusion Criteria:

None

Primary outcomes:
measure: Perceptions of physical therapists regarding the role, utilization, goals, and cultural issues of physical therapy interventions in the palliative care of functionally dependent elderly.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Missoula
country: United States
facility: The Univeristy of Montana, Transitional Doctor of Physical Therapy Program
state: Montana
Study officials:
affiliation: University of Montana
name: Ellen L Gakis-Day, BS PT, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00991861: Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis
Official title: Double-blind, Randomized, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41007 Once Daily and LAS41007 Twice Daily Versus LAS106521 Gel Twice Daily in the Treatment of Actinic Keratosis Grade I to II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
AK
NMSC
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2009-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the efficacy, safety and tolerability of either a once or twice daily topical application of LAS41007 compared to a twice daily application of LAS106521 in the treatment of actinic keratosis.


Eligibility criteria: Inclusion Criteria:

* At least 4-10 clinically assessed actinic keratosis grade I to II (according to Olsen et al, 1991) in the face/forehead and/or on the bald scalp
* The diameter of each AK target lesion is not less than 0.5 cm and not greater than 1.5 cm
* The target lesions must be located in overall 2 treatment areas with a size of 25 cm2 per treatment area

Exclusion Criteria:

* Have evidence of clinically significant or unstable medical conditions such as:

  * metastatic tumor or tumor with high probability of metastatic spread
  * heart failure (NYHA class III or higher)
  * immunosuppressive disorder (e.g. HIV)
  * hematologic, hepatic, renal, neurologic or endocrine disorder.
  * collagen-vascular disorder (e.g. cerebrovascular disorder or other bleedings).
  * gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage)
* Suffer from paresthesia in the treatment areas
* Show Cornu cutaneum of the skin and/or hypertrophic AK lesions in the treatment areas

Primary outcomes:
measure: Histological clearance of one pre-selected target lesion
timeFrame: Day 120
measure: Complete clinical clearance of all target lesions in the treatment areas
timeFrame: Day 120
Secondary outcomes:
measure: Physician's Global Tolerability Assessment (PGT)
timeFrame: Day 120
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Investigational Site
Study officials:
affiliation: Almirall Hermal GmbH
name: Christoph Willers, MD, MBA
role: STUDY_DIRECTOR
References: