louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01030055: Bioavailability and Food Effect Study of TKI258 (CSF Capsules vs. FMI Capsules)in Adult Patients With Advanced Solid Tumors
Official title: A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258, and the Effect of Food on the Bioavailability of TKI258, in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Cancer
Tumors
Keywords: Neoplasms
Cancer
Tumors
Administration, oral
Capsules
CHIR258
CHIR-258
CHIR 258
TKI258
TKI-258
TKI 258
Bioavailability
Food
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor


Eligibility criteria: Inclusion Criteria:

* Patients with an advanced solid tumor, except breast cancer,which has progressed despite standard therapy, or for which no standard therapy exists
* World Health Organization (WHO) performance status ≤ 2
* Patient must meet protocol-specified laboratory values

Exclusion Criteria:

* Patients with brain cancer
* Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
* Patients who have not recovered from previous anti-cancer therapies
* Female patients who are pregnant, breast feeding, or not willing to use an effective method of birth control

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Determine the relative bioavailability of the final market image form of TKI258 (monohydrate capsules) as compared to the clinical service form of TKI258 (anhydrate capsules)
timeFrame: 9 days
measure: Determine the effect of food on the bioavailability of TKI258
timeFrame: 22 days
Secondary outcomes:
measure: Characterize the safety and tolerability of TKI258, including acute and chronic toxicities
timeFrame: Up to 28 days after the last dose of study drug
measure: Evaluate preliminary evidence of anti-tumor activity of TKI258 in patients with advanced solid tumors.
timeFrame: Every 8 weeks until progression of disease
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: Durham
country: United States
facility: Duke University Medical Center Cancer Dept
state: North Carolina
city: Salt Lake City
country: United States
facility: University of Utah / Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02248155: Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)
Official title: Sifrol® Onset of Action and Impact on RLS: A 12-week Observational Study in Patients With Primary RLS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restless Legs Syndrome
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 2644
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from moderate to severe RLS recruited at office-based general practitioners and interists

Brief summary: The objectives of this Post Marketing Surveillance (PMS) are:

* Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical Global Impression Improvement scale (CGI- I)
* Evaluation of the time to reaching maintenance dose of pramipexole
* Evaluation of work productivity impairment associated with RLS based on the Work Productivity and Activity Impairment Questionnaire (WPAI) questionnaire


Eligibility criteria: Inclusion Criteria:

* Patients suffering from primary RLS who are eligible for Pramipexol (PPX) treatment could be included into the study
* Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pre-treated with dopaminergic medication
* Male of female patients of any age

Exclusion Criteria:

* The treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole

Primary outcomes:
measure: Assessment of RLS symptoms (IRLS) on a 4-point rating scale
timeFrame: up to 12 weeks
measure: Change from Baseline in WPAI by means of a patient questionnaire
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Number of patients with adverse drug reactions
timeFrame: up to 12 weeks
measure: Global assessment of efficacy by investigator on a 5-point scale
timeFrame: after 12 weeks
measure: Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale
timeFrame: up to 12 weeks
measure: Time to reach pramipexol maintenance dose
timeFrame: up to 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04324255: Von Willebrand Factor and Protein C Ratio in Graft Function After Liver Transplant
Official title: Von Willebrand Factor and Protein c Ratio-related Thrombogenicity With Systemic Inflammation is Predictive of Graft Dysfunction After Liver Transplantation: Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplant; Complications
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 1199
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: End-stage liver disease patients undergoing liver transplant

Brief summary: In liver cirrhosis (LC),the activity of von Willebrand factor (vWF)-cleaving enzyme ADAMTS13 is reduced in LC patients and consequent progression of liver injury. Remarkably, it has been reported that a severe vWF/ADAMTS13 imbalance develops during liver transplantation (LT) and persists even after LT. Such changes are thought to contribute to postoperative thrombotic complications, which may lead to early adverse events of thrombotic microangiopathy after living-donor LT (LDLT). We investigated whether vWFPCR could predict EAD or graft failure following LT and compared it with FVIIIPCR, procoagulant, such as vWF and FVIII and anticoagulant, such as PC.


Eligibility criteria: Inclusion Criteria:

patients who underwent LT

Exclusion Criteria:

deceased-donor liver transplant, and insufficient data, ABO-incompatible LT

Primary outcomes:
measure: Early allograft dysfunction
timeFrame: within 7 days after surgery
Secondary outcomes:
measure: Graft failure
timeFrame: 90 days
measure: intensive care unit stay
timeFrame: until the day of patients moving to general wards, through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical center
Study officials:
References:
Clinical trial NCT05339555: IUD Self-Removal Study
Official title: IUD Self-Removal: A Study to Pilot the Feasibility of a Novel Technique
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IUD
Keywords: IUD Removal
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study designed to test the effectiveness of several techniques for intrauterine device (IUD) self-removal and to understand patient preferences regarding IUD self-removal and indicators of success as well as understanding the impacts of IUD self-removal on other clinical care.

Detailed description: The Investigators propose to test a novel method for self-removal of IUDs in an effort to increase the proportion of patients who are able to successfully and safely remove their IUD when desired. Participants will attempt self-removal in office, where a provider will be able to remove the IUD if unsuccessful. Participants will be instructed on current and novel techniques and the investigators will examine indicators of success as well as patient and provider preferences.

Eligibility criteria: Inclusion Criteria:

* Presenting at clinic for IUD removal or exchange
* Willing and able to give consent with literacy in English or Spanish

Exclusion Criteria:

* Participants who are referred for a complicated IUD removal such as a stingless IUD, prior failed IUD removal attempt, or an IUD failure.

Primary outcomes:
measure: Effectiveness of IUD Self-Removal Techniques
timeFrame: Immediately after IUD Removal
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science Univeristy
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jessica Reid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04077255: EGFR-targeted Therapy for Gastric Cancer
Official title: Anti-EGFR Antibody (GC-1118) in Combination With Weekly Paclitaxel as a Second-line Therapy for Gastric and Gastroesophageal Junction Adenocarcinomas With Amplifications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Adenocarcinoma of the Stomach
Keywords: EGFR
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Korean Cancer Study Group
First posted: 2019-09-04
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Based on targeted NGS panel results, metastatic gastric cancer patients with gene amplifications will receive either anti-EGFR antibody (GC-1118) in combination with weekly paclitaxel as a second-line therapy.

Detailed description: Participants will receive each treatment if the gastric cancer tissue sample reveals either EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining

Eligibility criteria: Key inclusion criteria

1. Histologically-proven gastric and gastroesophageal junction adenocarcinoma
2. Refractory to first-line chemotherapy for metastatic disease
3. Presence of at least 1 measurable lesion according to RECIST version 1.1
4. EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining

Key exclusion criteria

1.Prior exposure to taxane or EGFR-targeted therapy

Primary outcomes:
measure: Response rate
timeFrame: Response rate will be assessed at 8 weeks.
Secondary outcomes:
measure: Progression-free survival
timeFrame: From date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, will be assessed up to 1 year.
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
Study officials:
affiliation: National Cancer Center, Korea
name: Hark K Kim, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04295655: Physiotherapy in Hypoxic AECOPD Patients
Official title: Feasibility and Efficacy of Physiotherapy in Hypoxic AECOPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD Exacerbation
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypoxia is considered a key player in many of the comorbidities that characterize COPD, such as pulmonary hypertension, skeletal muscle dysfunction, and systemic inflammation. These comorbidities are worsened during an exacerbation due to prolonged bed rest and treatment with steroids, showing a reduction in the quality of life, exercise tolerance, and a greater risk of death in these patients. Therefore, a better understanding of the safety and effectiveness of exercise training for AECOPD patients with resting hypoxemia is needed.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes
* A diagnosis of COPD made according to the criteria of the American Thoracic Society (ATS)
* With hypoxemia at rest defined as mean arterial oxygen saturation below 90%
* Agreed to participate

Exclusion Criteria:

* Unstable cardiovascular disease
* Orthopedic diseases in the upper and lower limbs
* Being in ICU or use of mechanical ventilation
* Motor sequelae from a neurological or cognitive impairment that interfere with the evaluation and the treatment
* Contraindications of electrotherapy

Primary outcomes:
measure: Lower limb strength
timeFrame: Baseline
measure: Lower limb strength
timeFrame: Up to 9 days
measure: Balance
timeFrame: Baseline
measure: Balance
timeFrame: Up to 9 days
measure: Dyspnea
timeFrame: Baseline
measure: Dyspnea
timeFrame: Up to 9 days
measure: Fatigue
timeFrame: Baseline
measure: Fatigue
timeFrame: Up to 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Granada.
country: Spain
facility: Faculty of Health Sciences. University of Granada.
state: Granada
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05962255: Sodium Chloride vs. Glucose Solute as a Volume Replacement Therapy During Decongestion in Acute Heart Failure
Official title: The Impact of Slow, Continuous Infusion of Sodium Chloride or Glucose Solution on Diuresis and Urine Composition During Decongestion of Acute Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Heart Failure
Congestion
Heart Failure
Keywords: acute heart failure
decongestion
volume replacement
sodium chloride
congestion
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomisation to infusion of 0.9% NaCl vs 5% glucose
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the differences in diuretic, natriuretic and clinical response to decongestion in patients receiving different replacement fluid regimens (0.9% sodium chloride vs 5% glucose) in acute heart failure.


Eligibility criteria: Inclusion Criteria:

* patients \>18 years old who sign the informed consent
* the primary cause of hospitalization is Acute Heart Failure with a need for intravenous Furosemide
* the start of the study within 24h of hospital admission

Exclusion Criteria:

* need for inotropic support
* end stage renal disease on dialysis
* serum sodium \> 148mmol/l or \< 130 mmol/l.

Primary outcomes:
measure: Urine volume change at individual timepoints during first day of the procedure.
timeFrame: 24 hours
measure: Urine volume change at individual timepoints during second day of the procedure.
timeFrame: 48 hours
measure: Urine composition at individual time points.
timeFrame: 72 hours
measure: Cumulative urine output at 24 hours.
timeFrame: 24 hours
measure: Cumulative urine output at hours.
timeFrame: 48 hours
measure: Total dose of furosemide.
timeFrame: 48 hours
Secondary outcomes:
measure: Total time on intravenous furosemide.
timeFrame: 3 months
measure: Renin-Angiotensin-Aldosterone system activity.
timeFrame: 24 hours
measure: Renin-Angiotensin-Aldosterone system activity.
timeFrame: 48 hours
measure: Heart Failure rehospitalization
timeFrame: 30 days
Other outcomes:
measure: Body weight
timeFrame: 24 hours
measure: Body weight
timeFrame: 48 hours
Locations:
city: Wroclaw
country: Poland
facility: Institute of Heart Diseases, Wroclaw Medical University
state: Lower Silesia
Study officials:
References:
Clinical trial NCT04432155: Xenon Inhalation for Treatment of Panic Disorder
Official title: A Double-Blind, Randomized, Placebo-Controlled Trial of Xenon Inhalation for Treatment of Patients With Panic Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Panic Disorder
Lead sponsor: Nobilis Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 200
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 is a double-blind, randomized, placebo-controlled, clinical trial in parallel groups in patients with panic disorder.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of panic disorder according to DSM-5.
* Male and female patients ≥18 years of age.

Exclusion Criteria:

* History of schizophrenia, bipolar and other psychotic disorders.
* Patients with underlying pulmonary disease, chronic obstructive pulmonary disease (COPD), asthma, severe lung disease and/or baseline oxygen saturations \<92% or any other respiratory conditions / diseases that may affect the respiratory function.
* Currently undergoing targeted empirically-driven psychotherapy for panic disorder or panic disorder-related symptoms.
* Currently undergoing exposure-based psychotherapy for any condition.

Primary outcomes:
measure: PDSS
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: PHQ-9
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06430255: Effects of Global Postural Re-education Versus Laser-guided Exercise in Non-specific Chronic Low Back Pain
Official title: Effects of Global Postural Re-education Versus Laser-guided Supervised Exercise in Individuals With Non-specific Chronic Low Back Pain: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Back
Lead sponsor: Taif University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effects of Global Postural Re-education Versus Laser-guided Supervised Exercise in Individuals With Non-specific Chronic Low Back Pain

Detailed description: The objective of this study will be to investigate the effectiveness of GPR or LGE, in addition to PNE and home exercise program. The primary outcomes will be pain intensity, disability, and fingertip to floor test. The secondary outcomes will be pain catastrophizing, kinesiophobia and depression.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 45 years.
* Diagnosed with NSLBP.
* Experiencing NSCLBP for ≥ 3 months and score at least 3/10 on the Numerical Pain Rating Scale (NPRS).

Exclusion Criteria:

* Diagnosed with a condition that hinders their ability to engage in physical exercise (e.g., uncontrolled diabetes, cardiovascular disease, orthopedic impairments; balancing problems).
* Diagnosed with severe spine conditions (such as fractures, tumors, ankylosing spondylitis, or inflammatory disorders).
* Diagnosed with neurological problems (such as spine nerve problems or cauda equina syndrome)
* Diagnosed with mental illness or severe cognitive impairment that made it impossible to follow the PNE program.
* With a physical condition that made it impossible to complete the PNE program (the timed "up and go" test had to be completed in 10 seconds at a minimum).
* Receiving alternate therapy for related pathologies (myopathies and neurological diseases) that prevented them from completing the PNE program.

Primary outcomes:
measure: Pain intensity
timeFrame: One month
measure: Disability
timeFrame: 7 weeks
measure: Fingertip-to-floor test
timeFrame: 7 weeks
Secondary outcomes:
measure: Pain catastrophizing
timeFrame: One month
measure: Kinesiophobia
timeFrame: One month
measure: Depression
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Taif University
name: Hosam Alzahrani, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00896155: Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy in Breast Cancer Patients
Official title: A Randomized Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy to Assess the Extent of Pulmonary Fibrosis and Disease Related Control and Survival in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pulmonary Fibrosis
Breast Cancer
Keywords: Breast cancer
Pulmonary fibrosis
tamoxifen
radiotherapy
Lead sponsor: Tata Memorial Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Indian Council of Medical Research
First posted: 2009-05-11
Enrollment: 260
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two hundred and sixty patients with breast cancer will be accrued into the study. After inclusion in the study, all the patients will be randomized into two arms. Arm 1 will receive Tamoxifen given concurrently with radiotherapy while in Arm 2 radiotherapy will be given followed by tamoxifen sequentially. The patients will be stratified for the following factors: a) BCS (Breast conservative surgery) versus MRM (modified radical mastectomy) and b) central lung distance (CLD) \> 2 cm.

Patients in both arms will continue tamoxifen for a period of 5 years. The patients will be evaluated by high-resolution computed tomography (HRCT) (baseline and at 2 years), serum transforming growth factor (TGF) beta levels (baseline and at 6 months) and diethylenetriaminepentaacetic acid (DTPA) aerosol clearance half life (baseline and at 6 months).


Eligibility criteria: Inclusion Criteria:

* Patients with large operable lesions (pT/cT \> 5 cm) or locally advanced breast cancers undergoing modified radical mastectomy or breast conservative surgery-(BCS) who need adjuvant post operative radiotherapy
* Patients post mastectomy requiring radiotherapy because of nodal positivity
* Completed planned chemotherapy schedule
* ER and/or PR positive patients
* Patients decided to be put on tamoxifen
* Patients reliable for follow up

Exclusion Criteria:

* Patients with BCT who have pT1 or pT2 breast lesions (N0,N1)
* Patients for palliative radiotherapy to the chest wall/breast/supraclavicular fossa
* Any patient requiring radiation to the axillary or internal mammary area
* Recurrent disease or metastatic disease
* Patients on concurrent chemotherapy and radiation

Primary outcomes:
measure: Development of Lung fibrosis
timeFrame: Three years
Secondary outcomes:
measure: Locoregional failure and distant failure
timeFrame: Three years
Other outcomes:
Locations:
city: Parel
country: India
facility: Tata Memorial Center
state: Mumbai
Study officials:
affiliation: Tata Memorial Hospital
name: Anusheel Munshi, MD
role: PRINCIPAL_INVESTIGATOR
References: