louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00035360: Phase III PEG-Intron in HIV-infected Patients (Study P00738)
Official title: Phase 3 Study of PEG-Intron in Heavily Treatment-experienced, HIV-infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
AIDS
Keywords: PEG-Intron
treatment experienced
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-05-06
Enrollment: 49
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 randomized, double-blind, multicenter trial testing 2 doses of PEG-Intron, 1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced HIV-infected patients compared to placebo. The study will evaluate the efficacy and safety of PEG-Intron when added to stable optimized background antiretroviral therapy in this patient population.

Detailed description: This study will randomize 675 patients (225 in each of the 3 arms) to either: PEG-Intron 1mcg; 3mcg or Placebo, at 90 centers worldwide. Each center will enroll approximately 10 patients.

Study drug will be added to optimized background anti-retroviral therapy of patients whose HIV RNA is incompletely suppressed by their therapy (HIV RNA 400-50,000 copies/ML) after 2-6 months.

A single dose reduction of 50% will be allowed for toxicity. An Interim Analysis will be conducted when 50% of patients have completed 24 weeks of therapy. The study treatment phase will be 48 weeks with monthly visits for virologic virologic and safety monitoring. The primary endpoint is change in HIV RNA from baseline to week to assess efficacy. Durability of response will be assessed at 48 weeks.

Eligibility criteria: Inclusion Criteria:

* HIV positive
* History of virologic failure on at least 2 antiretroviral regimens including exposure to at least one NRTI, one NNRTI and one PI
* HIV RNA \>400-\<50,000 copies/mL
* Laboratory parameters: platelet count (75,000u/L, hemoglobin \>9gm/dl, absolute neutrophil count \>1,000/uL, SGOT/SGPT\<5xULN.

Exclusion Criteria:

* Current ribavirin therapy
* Subjects with a recent diagnosis or history of moderate or severe depression requiring ongoing psychiatric intervention
* Females of childbearing potential who are breastfeeding, who are pregnant, or not using adequate birth control measures
* Concomitant use of immunosuppressants or cytotoxic agents
* History of seizure disorder requiring use of anticonvulsants

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01250860: Short-term Effects of the Simultaneous Use of Two Physiotherapeutic Methods in the Treatment of Adolescent Idiopathic Scoliosis - Pilot Study
Official title: Short-term Effects of the Simultaneous Use of Two Physiotherapeutic Methods in the Treatment of Adolescent Idiopathic Scoliosis - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Spirometry;
The Strength of Respiratory Muscles - MIP, MEP;
Kyphosis (Plurimeter-V)
The Angle of Trunk Rotation in Thoracic Part
Keywords: Manual therapy
DoboMed exercise
Spirometric test
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2010-12-01
Enrollment: 42
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The assessment of influence joint physiotherapy (DoboMed and OMT Kaltenborn - Evjenth) on the function of the respiratory system and the morphology of the ribcage in short-term intensive physiotherapy.


Eligibility criteria: Inclusion Criteria:

* girls aged 10 to 16
* one arc right side curve
* Cobb range 12 - 40 degrees

Exclusion Criteria:

* bigger Cobb range
* double arc curve
* no parent approval
* lack of cooperation

Primary outcomes:
measure: Simultaneous use of two physiotherapeutic methods in the treatment of Adolescent Idiopathic Scoliosis
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Medical University of Silesia
state: Silesia
Study officials:
References:
Clinical trial NCT06638060: Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Older Adults Department PHC
Official title: Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Older Adults Department PHC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aging
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
Collaborators: name: Excelar
name: Cloud DX Inc.
name: Bridge Health Solutions
name: Providence Healthcare
First posted: 2024-10-15
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Acute Care for Elderly Unit at SPH for 40 inpatients over the age of 65.

Brief summary: To confirm feasibility and accessibility of the CCPC Platform (Oxymotion, Bridge Health Solutions medication adherence software, CloudDX home kit) in two different environments - 1) hospital (Acute Care for Elderly Unit) and 2) at-home .


Eligibility criteria: Inclusion Criteria:

* Inpatients on the Acute care of the Elderly ward.

Exclusion Criteria:

* Lack of capacity to consent to the study including moderate-severe dementia or delirium
* Unable to use (or does not have a caregiver who can help put on) study monitoring device at home
* Unable to complete (or does not have a caregiver who can help complete) study questionnaires by electronic (mobile, tablet, or computer), paper, nor phone
* Patient with known allergic reactions to any part material of the device
* People under 40kg

Primary outcomes:
measure: Collect patient and clinicians' feedback about the CCPC Platform
timeFrame: From enrollment to the end of follow up at 10 days
measure: Collect patient and clinicians' feedback about the CCPC Platform
timeFrame: From enrollment to the end of follow up at 10 days
measure: Collect patient and clinicians' feedback about the CCPC Platform
timeFrame: From enrollment to the end of follow up at 10 days
measure: Confirm the technical goals of the CCPC platform are met.
timeFrame: From enrollment to the end of follow up at 10 days
measure: Confirm the technical goals of the CCPC platform are met.
timeFrame: From enrollment to the end of follow up at 10 days
measure: Confirm the technical goals of the CCPC platform are met.
timeFrame: From enrollment to the end of follow up at 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul&#39;sHospital
state: British Columbia
Study officials:
References:
Clinical trial NCT05397860: Radiofrequency Ablation With Gradual Radiofrequency Energy Increment for Hepatocellular Carcinoma Treatment
Official title: Radiofrequency Ablation for Hepatocellular Carcinoma Using Gradual Radiofrequency (RF) Energy Delivery Mode With Octopus Electrodes: A Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Liver Cirrhosis
Chronic Liver Disease
Keywords: Radiofrequency ablation
Gradual radiofrequency energy increment
Cone-unit ablation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Starmed
First posted: 2022-05-31
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate local tumor progression rate at 12 months after percutaneous radiofrequency ablation with gradual radiofrequency energy delivery mode with Octopus electrodes in patients with hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Child-Pugh Class A or B
* chronic hepatitis B or liver cirrhosis
* contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) within 60 days of scheduled radiofrequency ablation (RFA) date
* clinically diagnosed hepatocellular carcinoma (HCC), equal or less than 4 cm

Exclusion Criteria:

* number of HCC, equal or more than 3
* largest tumor size over 4 cm
* Child-Pugh class C
* presence of vascular invasion by HCC
* platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
* presence of extrahepatic metastasis

Primary outcomes:
measure: Local tumor progression rate
timeFrame: 12 months after radiofrequency ablation (RFA)
Secondary outcomes:
measure: Success rate of cone-unit ablation
timeFrame: Immediately after radiofrequency ablation (RFA)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02406560: A Study Comparing The Amounts of Tafamidis In The Blood With Or Without Food
Official title: A Phase 1, Open-label, Randomized, Crossover, Oral, Single Dose Study To Estimate The Relative Bioavailability Of Pf-06291826 (Tafamidis) Following Administration Of A Tafamidis Free Acid Tablet Formulation In Healthy Subjects Under Fasted And Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 12
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: Each subject will be given tafamidis after either a high fat meal or while fasted. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one week. After about 14 days, subjects will take either a different dose of tafamidis or the same dose under the opposite meal condition. Tafamidis concentrations from the three different conditions will be compared to determine if they are approximately the same.


Eligibility criteria: Inclusion Criteria: - Healthy males or females of non-child bearing potential. - Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria: - Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic). - Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.

Primary outcomes:
measure: Area under the Concentration-Time Curve (AUC)
timeFrame: 168 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 168 hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 168 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 168 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 168 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02433860: Evaluation of the Effectiveness of Pharmacists in Implementing the SCRIPT Protocol
Official title: Evaluation of the Effectiveness of Pharmacists in Implementing the Smoking Cessation and Reduction in Pregnancy and Treatment (SCRIPT) Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Providence Medical Research Center
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is a significant need for nicotine cessation programs for pregnant women in Spokane County. SCRIPT has been proven to be an effective method for smoking cessation in pregnant women. This study will evaluate the success of SCRIPT delivered by pharmacists. At the end of the study, the investigators hope to have three questions answered: 1) what is the quit rate of pregnant women in the Spokane area who receive the SCRIPT intervention delivered by pharmacists? 2) How does the quit rate compare to the quit rates of SCRIPT programs delivered by other health care providers as documented in the literature? And 3) Does the SCRIPT intervention have a significant effect on quit rates for pregnant women compared to current Spokane county quit rates? Urine cotinine tests will be used to document smoking status before delivery of the SCRIPT program, approximately one week after quit date and at \>36 wks gestation or at delivery for study participants.

Detailed description: 1. The goal of this project is to evaluate the success of pharmacists in delivering the SCRIPT smoking cessation program. The research questions that need to be addressed are: i. What is the quit rate of pregnant women in the Spokane area who receive the SCRIPT intervention delivered by a pharmacist? ii. How does this quit rate compare to the quit rates of other SCRIPT programs given by other health care providers (social workers, nurses, etc.)? iii. Does the SCRIPT intervention have a significant effect on quit rates for smoking pregnant women compared to current Spokane county quit rates?

Eligibility criteria: Inclusion Criteria:

* Pregnant
* nicotine use
* English speaking
* 18 years of age or older

Exclusion Criteria:

* Males due to pregnancy status not applicable

Primary outcomes:
measure: quit rates for nicotine for pregnant women
timeFrame: 2 yrs
Secondary outcomes:
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Providence Holy Family Hospital Anticoagulation and Pharmacotherapy Clinic
state: Washington
Study officials:
affiliation: Providence Holy Family, SHMC and PMP ACC/PHAC
name: Jennifer Taylor, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02626260: A Pilot Evaluation of Adhesives and How They Are Impacted by Output
Official title: A Pilot Evaluation of Adhesives and How They Are Impacted by Output
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2015-12-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates the impact real output has on the adhesion of adhesives.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation

Primary outcomes:
measure: Remaining adhesive area of adhesive
timeFrame: 30 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
References:
Clinical trial NCT05799560: The Effect of Therapeutic Touch and Reiki Application on Anxiety and Stress Levels in Female Academicians
Official title: Determination of the Effect of Therapeutic Touch and Reiki Application on Anxiety and Stress Levels in Female Academicians
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Anxiety
Keywords: academics
therapeutic touch
reiki
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 17
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Stress and anxiety form an integral part of organizational life in universities. Studies reveal that the stress experienced by academicians has increased dramatically in recent years. Stress affects employee performance. In order to reduce the stress level of female academicians, methods such as non-pharmacological treatment, massage that can be applied to support scientific medicine, acupressure, hot and cold application, therapeutic touch should be used. The non-pharmacological methods that investigators will look at in our research are therapeutic touch and reiki. The improvement of the balance in the body and the reduction of negative effects such as pain, stress and anxiety with non-pharmacological touch methods are explained by Gate Control and Endorphin theories. The universe of the research will be female academicians working at Osmaniye Korkut Ata University. participants will be determined by the block randomization method. Data; It will be collected using the Introductory Information Form, Depression, Anxiety and Stress Level Assessment Form. TT and Reiki application will have positive contributions as it is a non-pharmacological method, easy to apply and low cost. When the studies were examined, no other study was found in the same application as our study.

Therefore, in this study, it was aimed to evaluate the effect of therapeutic touch and reiki practice on anxiety and stress levels in female academicians.


Eligibility criteria: Inclusion Criteria:

* Academicians who do not have any communication problems
* Do not have psychological problems

Exclusion Criteria:

* Those who do not want to participate in the research

Primary outcomes:
measure: Depression Anxiety Stress Scale
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00144560: Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA)
Official title: An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, clinical pharmacology study to investigate drug-drug interaction in patients with RA.


Eligibility criteria: Inclusion criteria

* Patients who are diagnosed with RA according to the 1987 American College of Rheumatology (ACR) classification criteria
* Patients who contracted RA at least 6 months prior

Exclusion criteria

* Patients with Class IV Steinbrocker functional impairment at enrollment.
* Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept and have been receiving treatment with leflunomide, within 12 weeks before initiation of treatment with the probe drug

Primary outcomes:
measure: 20% improvement based on the ACR criteria compared with the baseline value.
timeFrame: throughout study
Secondary outcomes:
measure: Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.
timeFrame: Week 0,Week 1, Week 2
Other outcomes:
Locations:
Study officials:
affiliation: Chugai Pharmaceutical
name: Takahiro Kakehi
role: STUDY_DIRECTOR
References:
Clinical trial NCT02362360: Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
Official title: Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy
Colostomy
Keywords: Ostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2015-02-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.


Eligibility criteria: Inclusion Criteria:

* Have given written informed consent and in DK: signed a letter of authority
* Be at least 18 years of age and have full legal capacity
* Have had their ileostomy or colostomy for at least 3 months
* Able to use a baseplate size 15 to 40 mm
* Be able to handle the product themselves
* Normally experience faeces under the baseplate at least 3 times during 2 weeks
* Currently using a 2-piece flat product with mechanical coupling
* Willing to test both the Coloplast test product and the comparator product
* Willing to use an open bag size maxi during the investigation
* Willing to use Coloplast test product and comparator products without initial use of accessories (except tube paste / belt)
* Willing to use at least 1 baseplate every 3rd day during the investigation
* Is able to use a custom cut product
* Be suitable for participating in the investigation

Exclusion Criteria:

* Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer)
* Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment are allowed
* Are pregnant or breastfeeding
* Are participating in other interventional clinical investigations or have previously participated in this investigation
* Use irrigation during the investigation (flush the intestines with water)
* Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
* Have a loop ostomy
* Have known hypersensitivity towards any of the products used in the investigation

Primary outcomes:
measure: Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".
timeFrame: 21 +/- 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Soeborg
country: Denmark
facility: Trial Form Support ApS (TFS)
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Klinik für Allgemein-, Gefäß- und Thoraxchirurgie
city: Hamburg
country: Germany
facility: SIEWA Coloplast Homecare
city: Groningen
country: Netherlands
facility: QPS Netherlands
city: Larvik
country: Norway
facility: Sykepleierklinikken A/S, Larvik
Study officials:
References: