louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02596880: Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics
Official title: Sustained Viral Response Rate in 100 Subjects With Cirrhosis Due to Hepatitis C Treated With 12 Weeks of Sofosbuvir, Daclatasvir and Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Cirrhosis
Keywords: Hepatitis C
Cirrhosis
Sofosbuvir
Daclatasvir
Ribavirin
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir 400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if \<75 kg, 1200 mg/d if \>75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.

Detailed description: Cirrhosis due to Hepatitis C presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of treatment. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and daclatasvir (DCV) 60 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks. The current recommendation for cirrhotics is SOF/DCV/RBV for 24 weeks but that recommendation is based on the lack of data for shorter periods. In order to evaluate the response rate to the combination of SOF/DCV/RBV the investigators decided to treat 100 HCV cirrhotics with this combination for 12 weeks. Subjects include genotype 1 and 3 patients, the prevalent genotypes in Iran. Patients with Model for End stage Liver Disease (MELD) \> 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).

Eligibility criteria: Inclusion Criteria:

* Positive qualitative HCV RNA test on two occasions at least 6 months apart
* Cirrhosis proven by either of: 1. Liver biopsy, 2. Liver elasticity \> 12 kilopascal (KPa), 3. Clinical certainty (ascites, splenomegaly, small liver, low albumin, low platelet)

Exclusion Criteria:

* Renal failure (eGFR \< 30 cc/min),
* MELD score \> 20,
* Child's C (CTP score \> 12),
* Heart rate \< 50/min,
* Taking amiodarone

Primary outcomes:
measure: The sustained viral response rate
timeFrame: week 24 (12 weeks after end of treatment)
Secondary outcomes:
measure: Adverse drug events
timeFrame: week 2, 4, 8, 12, 24
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Reza Malekzadeh, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00533780: Effect of Healing Touch on the Experience of Women Undergoing Treatment for Breast Cancer
Official title: Effect of Healing Touch on the Experience of Women Undergoing Treatment for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Avon Foundation
First posted: 2007-09-21
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To learn what effect, if any, Healing Touch (a gentle, non-invasive form of energy work that promotes relaxation and can help manage the side effects of chemotherapy and radiation), has on physical symptoms, mood, and qualify of life for women undergoing treatment for breast cancer.


Eligibility criteria: Inclusion Criteria:- Patients undergoing treatment for breast cancer.

* Age 18 or over.
* Participants in Healing Partners Program. Exclusion Criteria:- Patients not under the care of a physician.
* Patients not able to come to regular healing touch sessions.

Primary outcomes:
measure: FACT-B Quality of Life Score
timeFrame: month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Lynn M Westphal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02456480: Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis
Official title: A Randomized, Double-blind, Placebo Controlled Study to Assess the Pharmacodynamics, Safety/Tolerability and Efficacy of Omiganan in Patients With Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients with mild to moderate atopic dermatitis (AD).


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects with mild to moderate AD 18 to 65 years of age, inclusive.
2. AD diagnosed by physician / medical specialist and that has been (intermittently) present for at least 1 year
3. Able to participate and willing to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

1. Have any current and / or recurrent clinically significant skin condition in the treatment area other than AD.
2. Any confirmed, active significant allergic reactions (urticaria or anaphylaxis) including allergic reactions against any drug, multiple drug allergies or (ingredients of) emollients.
3. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.

Primary outcomes:
measure: Pharmacodynamic (Local punch biopsy of a target lesion pre-dose and post treatment for the change in biomarkers including IL, filaggrin, TLR, IgE, IFN, and microbiome of the skin lesion)
timeFrame: 42 Days
measure: Clinical assessment (Change in patient symptoms over time using pruritis VAS)
timeFrame: 42 Days
measure: Clinical Assessment (Change in lesion size over time)
timeFrame: 42 Days
measure: Clinical assessment (Change in patient SCORAD scale score over time)
timeFrame: 42 Days
Secondary outcomes:
measure: Safety Assessment (Adverse events)
timeFrame: 42 days
Other outcomes:
Locations:
city: Zernikedreef 8
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
affiliation: Centre for Human Drug Research
name: J. (Koos) Burggraaf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Niemeyer-van der Kolk T, van der Wall H, Hogendoorn GK, Rijneveld R, Luijten S, van Alewijk DCJG, van den Munckhof EHA, de Kam ML, Feiss GL, Prens EP, Burggraaf J, Rissmann R, van Doorn MBA. Pharmacodynamic Effects of Topical Omiganan in Patients With Mild to Moderate Atopic Dermatitis in a Randomized, Placebo-Controlled, Phase II Trial. Clin Transl Sci. 2020 Sep;13(5):994-1003. doi: 10.1111/cts.12792. Epub 2020 May 1.
Clinical trial NCT03389880: Comparative Study Between Patellar Denervation and Non-patellar Denervation in Total Knee Arthroplasty With Patellar Resurfacing
Official title: Patellar Denervation in Total Knee Arthroplasty With Patellar Resurfacing to Relieve Postoperative Anterior Knee Pain: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellar Denervation
Non-patellar Denervation
Patellar Resurfacing
Lead sponsor: Navamindradhiraj University
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 241
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the post-operative anterior knee pain (AKP) between patellar denervation and non-patellar denervation in total knee arthroplasty with patellar resurfacing


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty

Exclusion Criteria:

* Valgus deformity
* History of inflammatory arthroplathy
* Previous fracture or open surgery on the same knee
* History of patellar instability

Primary outcomes:
measure: Change of post-operative anterior knee pain
timeFrame: Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery
Secondary outcomes:
measure: range of motion of knee
timeFrame: Change from baseline range of motion of knee at 3 months, 6 months, and 12 months after surgery
measure: Knee Society and Knee Society function score
timeFrame: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
measure: New patellar score (Bartlett score)
timeFrame: Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery
measure: Oxford knee score
timeFrame: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery
measure: patellar shift index
timeFrame: Change from baseline 3 months, 6 months, and 12 months after surgery
measure: prevalence of anterior knee pain
timeFrame: Change from baseline prevalence of anterior knee pain at 3 months, 6 months, and 12 months after surgery
measure: activity of daily living
timeFrame: Change from baseline activity of daily living at 3 months, 6 months, and 12 months after surgery
measure: post-operative complication
timeFrame: Number and type of post-operative complication at 3 months, 6 months, and 12 months after surgery
Other outcomes:
Locations:
city: Dusit
country: Thailand
facility: Navamindradhiraj University
state: Bangkok,
Study officials:
affiliation: Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
name: Satit Thiengwittayaporn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04021680: Clinical Effectiveness of First Trimester Pre-eclampsia Screening Program.
Official title: Far Eastern Memorial Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pre-eclampsia
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Gynecologic Oncology Group
First posted: 2019-07-16
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with with singleton pregnancy

Brief summary: To evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.

Detailed description: The incidence of pre-eclampsia is about 2-8%, it is a leading cause of maternal and perinatal mortality and morbidity. Both ACOG (American Congress of Obstetricians and Gynecologists) and NICE (National Institute for Health and Clinical Excellence) guideline advocate the use of traditional screening method, which uses demographic characters and medical history to identify high risk women. This method detects only 35-40% of pre-eclampsia women. Study has shown that combination of maternal factors and biomarkers (uterine artery pulsatility index, placenta growth factor, PlGF; pregnancy associated plasma protein-A, PAPP-A) improves the detection rate.

In Taiwan, the prevalence of pre-eclampsia is about 1.21%. The incidence of pre-eclampsia is correlated with maternal age, with a relative risk of 5.13-fold in women aged 40 and above. Marrying late predisposes these women at high risk of developing pre-eclampsia. Our institution will be implementing first-trimester screening program starting from April 2019, this study aims to evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.

Eligibility criteria: Inclusion Criteria:

- Women who are 20 years of age or older with singleton pregnancy between 11 to 13 + 6 weeks and received first trimester pre-eclampsia screening test in this institution.

Exclusion Criteria:

* Women who are not regularly inspected or not receiving prenatal care in this institution.
* Women who received first trimester pre-eclampsia screening test at other institution

Primary outcomes:
measure: The sensitivity and specificity of this screening program to detect preeclampsia
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT01614392: Lower Extremity Muscle and Function in the Elderly: Study 2
Official title: Lower Extremity Muscle and Function in the Elderly: Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Keywords: Resistance Exercise
Physical Activity
Mobility disability
Physical function
Muscle Strength
Older Adults
Mobility-Limited
Peak power and strength
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 52
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is looking to compare the effects of two uniquely different power training interventions (high force, lower velocity versus low force, high velocity) on changes in mobility status among older individuals at risk for mobility disability.


Eligibility criteria: Inclusion Criteria:

* Male and Female 70-85 yrs
* Community dwelling
* Short Performance Battery Score \>9
* BMI range 19-32 kg/m2
* Willingness to be randomized and come the laboratory for 20 weeks.

Exclusion Criteria:

* Acute or Terminal Illness
* MI in previous 6 months, symptomatic coronary artery disease or congestive heart failure.
* Upper or Lower extremity fracture in previous 6 months
* Uncontrolled hypertension (150/90mmHg)
* Neuromuscular diseases and drugs that affect neuromuscular function
* Hormone replacement therapy
* Participation in any regular endurance or resistance training exercise during previous 3 months

Primary outcomes:
measure: Leg Extensor Muscle Power
timeFrame: Change from baseline to Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging
state: Massachusetts
Study officials:
affiliation: Jean Mayer USDA Human Nutrition Research Center on Aging
name: Roger A Fieilding, Ph D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04625192: Trephine Osteotomy in Lateral Sinus Lift
Official title: Lateral Sinus Lift Technique Using Trephine Osteotomy With Simultaneous Implant Placement (Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sinus Lift
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Trephine osteotomy was used for lateral sinus lifting technique associated with sinus floor augmentation using the autogenous bone resulting from implant drilling using specialized trephine drills.

Detailed description: The study includes 14 patients in whom the lateral sinus lift technique was performed using the trephine osteotomy with simultaneous implant placement.

Sinus floor augmentation with autogenous bone graft resulting from implant site preparation with trephine drills.

Implant stability and rate of complications such as Schneiderian membrane perforation and bleeding will be assessed.

Patients will also provide their subjective assessment of postoperative pain and swelling. Vertical bone height, that will be gained, will be assessed radiographically

Eligibility criteria: Inclusion Criteria:

* Patients of both genders requiring implant placement in the posterior maxilla.
* Age between 20-50 years.
* Tooth extractions at the implant sites were performed at least 4 months before surgery.
* Residual bone height between the alveolar bone crest and the sinus floor ranges from 4 to 6 mm.
* Patients who are willing and fully capable to comply with the study protocol

Exclusion Criteria:

* Maxillary sinus pathologies (sinusitis, long standing nasal obstruction)
* Any disease contraindicating surgery (e.g. uncontrolled diabetes)
* Heavy smokers
* Acute oral infections
* Poor oral hygiene
* A history of radiotherapy or chemotherapy of the head and neck region

Primary outcomes:
measure: Change in Implant stability
timeFrame: at baseline and 6 months
measure: change in bone density
timeFrame: at baseline, 3rd and 6th months
measure: change in bone volume
timeFrame: at baseline, 3rd and 6th months
measure: change in bone vertical bone height
timeFrame: at baseline, 3rd and 6th months
Secondary outcomes:
measure: post operative pain
timeFrame: after 1 week
measure: Postoperative edema
timeFrame: after 1 week
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT03473392: One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections
Official title: One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exchange of Prosthetic Joint
Prosthetic Joint Infection
One-step Exchange
Keywords: pre-treatment
antibiotherapy
prosthetic joint infection
treatment failure
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 13
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: patients having had puncture which allowed to identify bacteria responsible for the IPA and having had a pre-treatment for a few days against those bacteria before a one-step exchange of prosthetic joint

Brief summary: The results found in the literature do not allow to define objectively the indications respective for a one-step or a two-step exchange of prosthetic joint. Some criteria could help to decide for one-step exchange or two-step exchange: bacteria is/are identified, profile of the bacteria, anesthetic difficulties,..

A puncture could allow to identify the bacteria involved in the prosthetic joint infection (PJI) and an antibiotherapy for a few days can be given to the patient in order to decrease the inoculum. Then, a one-step exchange can be performed.

The purpose of this study is to describe the management of patients who had a pre-treatment before a one-step exchange of their prosthetic joint.


Eligibility criteria: Inclusion Criteria:

* patient with prosthetic joint infection and having had a pre-treatment, managed at the Croix-Rousse Hospital
* \> 18 years old

Exclusion Criteria:

-

Primary outcomes:
measure: bacterial epidemiology
timeFrame: at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary outcomes:
measure: Treatment failure
timeFrame: at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Tristan FERRY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00826592: Comparison of Video-Based Versus Written Patient Education on Atopic Dermatitis
Official title: Comparison of Video-based Versus Written Patient Education on Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Atopic Eczema
Infantile Eczema
Hand Eczema
Keywords: patient education
dermatology patient education
atopic dermatitis
atopic dermatitis education
atopic eczema
infantile eczema
hand eczema
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' knowledge of atopic dermatitis and their disease severity, measured by the Patient-oriented Eczema Measure (POEM), after viewing the educational materials.

Detailed description: We plan to conduct a randomized, controlled trial comparing the effect of video-based patient education with written instruction on subjects' understanding of atopic dermatitis and their disease severity.

Subjects randomized to the video-based education arm will be instructed to watch a video on the classifications, aggravating factors, and treatment of atopic dermatitis. Subjects randomized to the written education arm will receive written information on the classifications, aggravating factors, and treatment of atopic dermatitis. The contents of the video and the written educational materials will be comparable.

At the end of the study period, 3 months later, subjects will be interviewed regarding their comprehension and attitude towards video-based and written education materials. Additionally, we will use the Patient-oriented Eczema Measure (POEM) questionnaire to assess the difference in subjects' disease severity between the 2 arms.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older at time of consent, may be men or women.
* Able to adhere to the study visit schedule and other protocol requirements.
* Capable of giving informed consent.

Exclusion Criteria:

* Non-English speaking individuals.

Primary outcomes:
measure: Subjects' disease severity measured by the patient-oriented eczema measure (POEM).
timeFrame: 3 months
Secondary outcomes:
measure: Subjects'comprehension and attitude towards video-based and written education materials.
timeFrame: 3 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: April Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
References: