louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02057536: The Effect of an Exercise Program in Breast Cancer Patients With Joint Pain While Taking Aromatase Inhibitors.
Official title: Pilot Study for the Effect of Exercise Intervention in Breast Cancer Patients With Arthralgias Receiving Aromatase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women With ER Positive Breast Cancer Taking (AI) w Joint Discomfort and Stiffness
Keywords: estrogen receptor positive, aromatase inhibitors, exercise,
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine if patients taking aromatase inhibitors (AI), who are experiencing joint discomfort and stiffness, would have reduction in this discomfort and stiffness by participating in a directed exercise program. The overarching objective is to improve patient compliance with the medication and ultimately clinical outcome.

In this pilot study, we will utilize a scientific approach for proof of concept employing both objective (inflammatory cytokine profiles and Physical Therapy (PT) measurements) and subjective (patient perception) methods to support an evidence based clinical plan. Patients will be divided into two cohorts. Group A will receive AI therapy with a directed exercise program. Group B will receive AI therapy without a directed exercise program. Data will be collected when both cohorts of patients enroll in the study, at the end of PT for Group A and, at the end of 8 weeks for Group B. At these time points, both groups will undergo a PT evaluation; have blood drawn for cytokine profiles; answer questions on an iPad that includes: the Pain Disability Index, the PHQ-4 (Psycological Health Questionaire depression scale, and pain level scale.


Eligibility criteria: Inclusion Criteria:

* 1. Women over age 40 with histological evidence of hormone receptor positive breast cancer.

  2. Post- menopausal 3. Adjuvant AI therapy. 4. Significant joint discomfort/stiffness when attempting activities of daily living which began or significantly increased after initiation of AI therapy.

  5. Currently not in an active directed exercise program (\>60 minutes 2x/wk)

Exclusion Criteria:

1. Preexisting RA or fibromyalgia. 2. Systemic metastasis 3. ECOG performance status of greater than 2.

-

Primary outcomes:
measure: Pain Disability Index
timeFrame: 8 weeks
Secondary outcomes:
measure: Plasma levels of inflammatory markers.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care/Helen F. Graham Cancer Center
state: Delaware
Study officials:
References:
Clinical trial NCT01579136: Do Home Monitors Improve Blood Pressure Control?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Diabetes Mellitus
Lead sponsor: Exempla Saint Joseph Hospital
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if home blood pressure monitors can help decrease blood pressure in patients with diabetes at a low income clinic.


Eligibility criteria: Inclusion Criteria:

* over 18 years old,
* diabetes as defined by HgA1C over 6.5%,
* uncontrolled blood pressure (SBP \> 130 and or DBP \> 80)

Exclusion Criteria:

* pregnancy,
* transplanted organ,
* MI/CHF/CVA within 3 months,
* dialysis,
* arrhythmia,
* metastatic cancer,
* dementia,
* visual or hearing difficulties

Primary outcomes:
measure: change in blood pressure over time
timeFrame: baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Caritas Clinic, Exempla Saint Joseph Hospital
state: Colorado
Study officials:
References:
Clinical trial NCT04691336: Individualized Plan for Improving Adherence to Portable Oxygen Therapy in Patients With Respiratory Pathology
Official title: Piloto Study of an Individualized Plan for Improving Adherence to Portable Oxygen Therapy in Patients With Respiratory Pathology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
ILD
Dyspnea
Lead sponsor: Air Liquide Healthcare Spain
Sponsor class: INDUSTRY
Collaborators: name: Hospital Sant Joan de Deu
First posted: 2020-12-31
Enrollment: 22
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: Pilot study with patients with prescription of portable oxygen therapy, to test the impact on adherence of a patient-centered empowerment program, with contents on the nature of the respiratory pathology, the symptom of dyspnea, the benefits of the therapy, adjustment expectations and beliefs, as well as health habits.

Detailed description: All patients were summoned to the care center, being evaluated individually by a nurse, and based on the results, a care plan adapted to the specific needs and objectives was initiated. This care plan involved monitoring using different channels (face-to-face, telephone), with the main objective of monitoring the evolution of compliance, adherence and improving the quality of life of patients. The interventions that were carried out were educational and formative (using counseling communication skills), and technological (using monitoring tools in specific cases). The empowerment program was an educational session in which the nurse discussed content about dyspnea, the benefits of therapy, etc.

Eligibility criteria: Inclusion Criteria:

* Adult patients (over 18 years old) with prescription of portable oxygen therapy by the Pneumology Service of the Sant Joan de Dèu Hospital in Manresa.

Exclusion Criteria:

* Psychophysical inability to carry out questionnaires or refusal to answer them.
* Severe displacement problems.

Primary outcomes:
measure: Adherence - Changes
timeFrame: Day 1 and Day 90
measure: Dyspnea - Changes
timeFrame: Day 1 and Day 90
measure: Quality of Life - Changes
timeFrame: Day 1 and Day 90
measure: Emotional State - Changes
timeFrame: Day 1 and Day 90
measure: Activities
timeFrame: Day 1 and Day 90
measure: Social Relations
timeFrame: Day 1 and Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: David Rudilla
Study officials:
affiliation: Air Liquide Healthcare
name: David Rudilla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rudilla D, Valenzuela C, Beceiro MJ, Alonso T, Ancochea J. Fibrosis pulmonar idiopática y emociones. Una revisión sobre los aspectos psicológicos de la enfermedad. Rev Patol Respir. 2018; 21(2): 54-60
citation: Rudilla D, Oliver A, Galiana L, Barreto P. A new measure of home care patients' dignity at the end of life: The Palliative Patients' Dignity Scale (PPDS). Palliat Support Care. 2016 Apr;14(2):99-108. doi: 10.1017/S1478951515000747. Epub 2015 Jun 11.
Clinical trial NCT02286336: The Minimum Effective Concentration of Ropivacaine in Ultrasound-guided Supraclavicular Block
Official title: The Minimum Effective Concentration of Ropivacaine in Ultrasound-guided Supraclavicular Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Minimum Effective Concentration of Local Anesthetic
Keywords: minimum effective concentration
ropivacaine
ultrasound-guided supraclavicular block
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the minimum effective concentration of local anesthetic (ropivacaine 40mL) required to produce an effective double-injection USG-SCB for surgical anesthesia in 90% of patients (MEC90) in young group (18-40 years) and in middle aged group (40-65 years) of patients scheduled for elective surgery of one upper limb distal to the shoulder.

Detailed description: The study is based on biased coin design, and the concentration of LA for the next patient is determined by the result of the last one. In the case of block failure, the concentration will be increased by 0.025%. Conversely, block success will result in either a reduction in concentration by 0.025% (probability 11%) or no change in concentration (probability 89%). A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous nerves) at 10-min intervals up to 30 min after completion of the block. Finally, MEC90 is calculated by isotonic regression.

Eligibility criteria: Inclusion Criteria:

1. age between 18 and 65 years
2. ASA 1-3
3. body mass index between 18 and 35kg/m2

Exclusion Criteria:

1. inability to consent to the study
2. pregnancy
3. allergy to local anesthetics
4. preexisting neuropathy or coagulopathy
5. prior surgery in the supraclavicular region

Primary outcomes:
measure: The Minimum Effective Concentration of Ropivacaine in Ultrasound-guided Supraclavicular Block
timeFrame: up to 6 months
Secondary outcomes:
measure: Block success
timeFrame: up to 30 minutes after nerve block is performed
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
name: Ailin Luo, MD.,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03317236: Bioequivalence Study of Two Extended Release Formulations Containing 50 mg of Quetiapine.
Official title: Bioequivalence Study of Quetiapine in Healthy Volunteers, After Administering a Single Dose of the Test Extended Release Formulation, Kemoter XR With Respect to the Reference Product, Etiasel XR ® From AstraZeneca S.A.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Bioequivalence
Quetiapine
Lead sponsor: Laboratorio Elea Phoenix S.A.
Sponsor class: INDUSTRY
Collaborators: name: DominguezLab S.R.L.
First posted: 2017-10-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-dose, two-way crossover.
Primary purpose: OTHER

Brief summary: Bioequivalence study of quetiapine in healthy volunteers, comparing the test extended release formulation, Kemoter XR with respect to the reference product, Etiasel XR ® from AstraZeneca S.A., under a single-dose, two-way crossover design.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent.
* Healthy volunteers according to medical history, physical exam, clinical laboratory, chest X-rays and ECG.
* Gender: males and non pregnant females
* Age: 18 to 55 years.
* Body mass index: 19 to 27 kg/m\^2.

Exclusion Criteria:

* History of liver or renal disease, or psychiatric disorders.
* History of drug or alcohol abuse during the previous two years.
* Smokers of more than 10 cigarrettes a day.
* Any kind of medicines taken during the previous two weeks.
* Any history of disease or disorders clinically significant according to the Principal Investigator.
* Abnormal ECG.
* Abnormal chest X-ray.
* Hypersensitivity to quetiapine or excipients within the formulations.
* Positive diagnostic test for HIV or hepatitis A, B or C virus.
* Breast feeding females.
* Positive beta-HCG test.
* Positive drug test in urine.
* Participation in clinical trials in the previous three months.
* Blood donation in the previous three months.
* Clinically significant laboratory results.
* Subjects seeking to initiate any medical or pharmacological treatment.
* Subjects unwilling to keep fasting or diet indications.
* Uncooperative subjects.

Primary outcomes:
measure: Cmax
timeFrame: 36 hours
measure: AUC
timeFrame: 36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Paraná
country: Argentina
facility: DominguezLab
state: Entre Ríos
Study officials:
affiliation: DominguezLab S.R.L.
name: María C Fritz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02347436: Does Benign Prostatic Obstruction Cause Hypertension?
Official title: Effect of Transurethral Prostate Resection on 24 Hour Blood Pressure Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Hypertension
Keywords: Transurethral Resection of Prostate
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2015-01-27
Enrollment: 20
Sex: MALE
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on the waiting list for inguinal hernia repair, hydrocele operation, or transurethral resection of the prostate, at St Olavs University Hospital, Department of Surgery, Trondheim, Norway

Brief summary: The known correlation between benign prostatic hypertrophy (BPH) and hypertension could be explained by 3 theoretical pathway models. Whether hypertension causes BPH, BPH causes hypertension or the two are caused by a common factor is currently unknown.

In this study it will be investigated whether hypertension is due to the direct effects of infravesical obstruction to urinary outflow in patients with benign prostatic hyperplasia. The approach will be blood pressure measurement in patients who will have a resection of the prostate.


Eligibility criteria: Inclusion Criteria:

* Listed for inguinal hernia repair or hydrocele repair or transurethral resection of the prostate
* signed informed consent

Exclusion Criteria:

* Treatment with antihypertensive medication that has been started within 3 months of inclusion.
* Treatment with antihypertensive medication that has been started after inclusion and before final blood pressure measurements have been obtained 6 months after operation.
* Any reason that the investigator deems that the participant will not comply with follow-up.

Primary outcomes:
measure: change in blood pressure
timeFrame: 7,5 months
Secondary outcomes:
measure: prostate symptom severity assessed by 'International prostate severity score' (questionnaire)
timeFrame: 7,5 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital, Department of Urology
Study officials:
affiliation: St Olavs University Hospital
name: Carl-Jørgen Arum, md phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00132236: Nurse Smoking Cessation of Patients With Chronic Obstructive Pulmonary Disease (COPD) With Nicotine Replacement Therapy (NRT) and Behavioral Support
Official title: Smoking Cessation of Patients With COPD: A Multi-Center, Randomized, Placebo Controlled Nurse Conducted Smoking Cessation Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Smoking
COPD
Keywords: smoking cessation
nicotine sublingual tablets
behaviour support
smoking reduction
quality of life
COPD
weight
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2005-08-19
Enrollment: 300
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 is a smoking cessation study with COPD patients where the researchers wanted to evaluate if nicotine sublingual tablets or placebo combined with low or high individual support could increase ½ and 1 year quit rates.

Detailed description: Placebo, controlled, randomized, double-blind trial with 400-1000 smoking COPD patients with FEV-1 \< 90 % predicted normal with the use of nicotine sublingual nicotine tablets or placebo for 12 weeks combined with individual clinic visits with low or high intensity conducted by trained nurses in several centres in pulmonary clinics in Denmark. Outcome was smoking cessation and smoking reduction after ½ and 1 year as self declared smoking status confirmed by carbon monoxide in expired air\< 10 ppm. Secondary outcomes were change in body-weight, quality of life (SF-36 and SGRQ), symptoms, lung function, adverse events.

Eligibility criteria: Inclusion Criteria:

* COPD patients (FEV1/FVC\<70% and FEV1\<90 % predicted)
* Smoking 1 cigarette daily or more
* Willing to follow the protocol

Exclusion Criteria:

* Used NRT or bupropion the last week
* Not able or willing to adhere to the protocol
* Estimated survival \< 1 year

Primary outcomes:
measure: smoking cessation after 6 and 12 months
Secondary outcomes:
measure: smoking reduction after 12 months
measure: change in quality of life (St. George Respiratory Questionnaire)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept. pulm. medicine, Århus kommunehospital
city: Copenhagen
country: Denmark
facility: Dept. pulm. medicine, Bispebjerg Hospital
city: Frederiksberg, Copenhagen
country: Denmark
facility: Pulm. Dept., Frederiksberg Hospital
city: Hellerup
country: Denmark
facility: Pulm. Dept, Gentofte University Hospital
city: Helsingør
country: Denmark
facility: Dept of Pulm. medicine, Helsingør Sygehus
city: nykøbing Falster
country: Denmark
facility: Dept. pulm. medicine, Nykøbing Falster Sygehus
city: Odense
country: Denmark
facility: Pulm. dept, Odense University Hospital
Study officials:
affiliation: Pulm. dept. Gentofte University Hospital
name: Philip Tønnesen, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00962936: Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
Official title: Phase I/II Study to Evaluate the Safety and Tolerability of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
HCV Genotype I infection
Liver disease
Lead sponsor: CureTech Ltd
Sponsor class: INDUSTRY
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2009-08-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate whether an investigational monoclonal antibody, CT-011, is safe to give and if it helps patients with hepatitis C virus (HCV). Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Results of this trial will help doctors obtain additional information with regard to the safety and efficacy of CT-011 as a potential treatment for HCV.


Eligibility criteria: Inclusion Criteria:

1. Patient is between 18 and 60 years of age, both genders.
2. Biopsy proven infection with Hepatitis C genotype 1.
3. Positive for anti-HCV.
4. Chronically infected for at least 3 months from diagnosis.
5. ECOG performance status ≤ 1.
6. Previous therapy with interferon +/- Ribavirin or Peginterferon +/- Ribavirin or ineligibility for this type of therapy or for liver transplantation.

Exclusion Criteria:

1. Patients who received any type of anti viral treatment during the 3 months prior to enrollment.
2. Any history or active malignancy.
3. History of major organ transplantation with an existing functional graft.
4. Patients who received any systemic concurrent therapy within the last 4 weeks.
5. Patients progressing to acute liver failure (ALF).

Primary outcomes:
measure: To assess the safety and tolerability of CT-011 in patients with Chronic Hepatitis C due to HCV Genotype I infection
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Yaron Ilan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01995136: Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma
Official title: Investigation of the Effect of Travoprost Ophthalmic Solution of Lowering Intraocular Pressure in Patients With Normal Tension Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Normal Tension Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Ocular hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-11-26
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004% ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of normal tension glaucoma.
* Must sign an Informed Consent form.
* IOP within protocol-specified range.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Pregnant and lactating women, or women who intend to become pregnant during the study period.
* Advanced and serious glaucoma, as specified in protocol.
* Complicated chronic or recurrent uveitis, scleritis or corneal herpes.
* History of ocular trauma, intraocular surgery or laser surgery for the included eye.
* Ocular-infection and severe ocular complication.
* Best-corrected visual acuity (BCVA) worse than 0.2 decimal.
* Difficulty in conducting applanation tonometry for the included eye as determined by the doctor.
* Severe or serious hypersensitivity to prostaglandin analogues or any ingredients used in the study.
* Use of IOP lowering ophthalmic solutions other than TRAVATAN Z® or oral carbonic anhydrase inhibitor (Diamox, etc.) during the study period.
* Use of any adrenocorticosteroids during the study period.
* Use of IOP lowering ophthalmic solution within the past 30 days.
* Regarded by doctor as not suitable for study participation.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12
timeFrame: Baseline (Day 0), Week 4, Week 8, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Alcon Japan, Ltd.
Study officials:
affiliation: Alcon Japan, Ltd.
name: Danyel Carr, MS
role: STUDY_DIRECTOR
References: