louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04382248: The Integration of a Mobile App Platform With Biomarkers in Kidney Transplantation
Official title: Next Generation Self Management: The Integration of a Mobile App Platform With Biomarkers in Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Compliance
Keywords: kidney transplant
teens
mobile app
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: CareDx
First posted: 2020-05-11
Enrollment: 22
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the feasibility and acceptability of a mobile app to improve self-management skills and medication adherence in kidney transplantation, to assess the clinical benefit of mobile app in combination with tailored coaching using text messaging to enhance patient activation, self-management and medication adherence and to determine whether immunological biomarkers such as cell-free DNA and donor specific antibodies are associated with self-management and medication adherence.


Eligibility criteria: Inclusion Criteria:

* 1) age 12-40 kidney transplant recipients with stable kidney function at least one month from the time of transplantation
* 2) have and use a smartphone
* 3) patients without pre-formed antibodies

Exclusion Criteria:

* 1) Patients \<12 or \>40
* 2) patient with pre-existing antibodies
* 3) patients with rejection at the time of enrollment
* 4) patients without a smartphone
* 5) patients with developmental delay or psychological impairment and unable to use an app

Primary outcomes:
measure: Change in patient activation scores as measured by Patient Activation Measure
timeFrame: baseline, 3 months, 6 months
measure: Change in self-management as measured by Partners In Health survey
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Medication adherence as measured by self-tracking
timeFrame: up to 6 months
measure: Medication adherence as measured by blood levels
timeFrame: up to 6 months
measure: Presence of cell-free DNA
timeFrame: up to 6 months
measure: Presence of donor-specific antibodies
timeFrame: up to 6 months
measure: Allograft function as measured by urine protein/creatinine ratio
timeFrame: up to 6 months
measure: Allograft function as measured by serum creatinine
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Eileen Chambers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01886248: Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation
Official title: Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatic Veno-Occlusive Disease
Keywords: hepatic veno-occlusive disease after hematopoietic stem cell transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 32
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

1. Patients with hepatic veno-occlusive disease after hematopoietic stem cell transplantation. The following criteria will be used.

   1. Two of the following

      * Serum total bilirubin \> 2.0 mg/dL
      * Hepatomegaly or right upper quadrant pain of liver origin
      * Unexplained weight gain of\>2% over baseline because of fluid accumulation
   2. Patients with pathologic diagnosis.
2. Patients with informed consent

Exclusion Criteria:

1. Pregnant or nursing women.
2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.
4. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
5. History of anaphylactic reaction to the study drug

Primary outcomes:
measure: AT-III level before 5th dose of AT-III
timeFrame: up to 14 days
Secondary outcomes:
measure: AT-III level before 9th dose
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Chongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Hyoung Jin Kang, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04120948: Laser Tongue Debridement for Oral Malodor
Official title: Laser Tongue Debridement for Oral Malodor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Halitosis
Lead sponsor: New York Head & Neck Institute
Sponsor class: OTHER
Collaborators: name: Biolase Inc
name: Ohio State University
First posted: 2019-10-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Malodor is a multifactorial condition with oral pathology representing the main culprit and the tongue being the first to second contributor to the malodor. Bacterial load can represent a quantifiable measure regardless of the original pathology. It is hypothesized that reduction in malodor can be represented by tongue changes both in appearance, bacterial and biofilm load reduction (measured by CFU and volatile gases measurement), organoleptic measurement and subjective improvement.

Methods: A randomized controlled prospective study under IRB approval. Diagnostic criteria for enrollment and follow up were organoleptic test by 2 judges, halimeter reading, tongue colores changes HALT questionnaire and direct aerobic and anaerobic tongue cultures measured by CFU. Patients were treated with laser tongue debridement (LTD) with an Er,Cr:YSGG solid state laser has been shown to be effective in biofilm reduction.


Eligibility criteria: Inclusion Criteria:

* an individual (male or female) who can understand and voluntarily sign an informed consent form
* a baseline organoleptic oral malodor score of at least 2

Exclusion Criteria:

* severe caries,
* signs of gingival inflammation on intraoral exam
* possible extra-oral halitosis (tonsillitis, sinusitis, and pulmonary pathologic conditions, or a condition that may contribute to systemic halitosis, such as hepatic cirrhosis or uncontrolled diabetes)
* antibiotic treatment within 1 month prior to study
* pregnant

Primary outcomes:
measure: Halimeter measurement
timeFrame: change from baseline to 1 month
Secondary outcomes:
measure: HALT questionnaire
timeFrame: change from baseline to 1 month
Other outcomes:
measure: bacterial load
timeFrame: change from baseline to 1 month
Locations:
city: New York
country: United States
facility: New York Head & Neck Institute offices
state: New York
Study officials:
References:
citation: Krespi YP, Kizhner V, Wilson KA, Sivriver A, Low S, Khosravi Y, Stoodley P. Laser tongue debridement for oral malodor-A novel approach to halitosis. Am J Otolaryngol. 2021 Jan-Feb;42(1):102458. doi: 10.1016/j.amjoto.2020.102458. Epub 2020 Mar 13.
Clinical trial NCT01084148: Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis
Official title: Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uremic Xerosis
Lead sponsor: Orfagen
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 237
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: Primary objective:

To demonstrate the long-term efficacy (response to treatment during initial therapy, time to relapse without treatment, durability and lesional recurrence during maintenance therapy) of V0034 CR 01B cream on uraemic xerosis in the real-life setting.

Secondary objectives:

1. To assess the local tolerance of V0034 CR 01B after long-term use
2. To assess the patient benefit and acceptability of V0034 CR 01B


Eligibility criteria: Inclusion Criteria:

1. Patients of both sexes, of at least 18 years of age
2. Women of childbearing potential having a reliable contraceptive method
3. Patients undergoing maintenance renal dialysis (MRD), i.e. either haemodialysis or peritoneal dialysis, due to chronic renal failure
4. Patients whose xerosis is related to their renal insufficiency status (uraemic xerosis)
5. Patients suffering from xerosis with a severity score of at least two, on at least one of the five tests areas (right lower leg, left lower leg, forearm with no arterio-venous shunt, chest, dorsum of the neck)

Exclusion Criteria:

1. Patients under 18 years of age
2. Women with childbearing potential having a positive pregnancy test at baseline
3. Patients undergoing renal dialysis for another reason than chronic renal insufficiency
4. Patients whose xerosis is due to another reason than their MRD status
5. Patients suffering from mild xerosis (i.e. score less than two on all the xerotic test areas)
6. Patients with a known history of allergy to one of the ingredients contained in the test product
7. Patients with an intercurrent condition which may interfere with a good conduct or the study parameters of the study
8. Patients treated with any other emollient/moisturising topical preparation within the seven days prior to study entry
9. Patients who participated in a study within the three months prior to study entry
10. Patients who are not affiliated to health insurance
11. Patients who are not able or willing to follow the study instructions -

Primary outcomes:
measure: Treatment Response of Xerosis
timeFrame: 28 days
Secondary outcomes:
measure: Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B
timeFrame: 133 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03979248: A Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole and BMS-986165 on How Fast and Complete The Drug is Absorbed Into the Body of Healthy Participants
Official title: An Open-Label, Single-Sequence Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole on the Pharmacokinetics of BMS-986165 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-06-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of stomach acid suppression by rabeprazole and BMS-986165 on how fast and complete the drug is absorbed into the body of healthy participants.


Eligibility criteria: Inclusion Criteria

* Healthy participant, as determined by medical history, physical examination, ECGs, and clinical laboratory determinations
* Body mass index of 18.0 kilogram per meter square (kg/m\^2) to 32.0 kg/m\^2
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) greater than (\>) 80 milliliter per minute per 1.732 meter square (mL/min/1.732 m\^2)

Exclusion Criteria:

* Any major surgery within 4 weeks of study drug administration
* Use of any prescription drugs or over-the-counter acid controllers
* Positive urine screen for drugs of abuse, alcohol, or cotinine
* History of allergy to BMS-986165, rabeprazole, or related compounds

Other protocol inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of BMS-986165
timeFrame: Day 1 and Day 9
measure: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T]) of BMS-986165
timeFrame: Day 1 and Day 9
measure: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) of BMS-986165
timeFrame: Day 1 and Day 9
Secondary outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to Day 12
measure: Percentage of Participants with Clinical Laboratory Values, Vital Signs, and Electrocardiograms (ECGs)
timeFrame: Up to Day 12
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences - Netherlands
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03554252: Comparison of Different Frames of Numerical Information in Cochrane Plain Language Summaries
Official title: Comparison of Different Frames of Numerical Information in Cochrane Plain Language: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Participants will be randomly given one of two formats containing descriptions of health interventions. In one format, participants will have to read short summaries where results of the intervention are presented as frequencies and the side effects of health intervention are presented as percentages, while in another format the frames will be reversed (results will be presented as percentages and side effects as frequencies). After reading, participants will be asked several questions about the content of the summary and its conclusions.


Eligibility criteria: Inclusion Criteria:

* Patients who are visiting their family doctor, and are at least 18 old. Students of biomedical studies at University of Split School of Medicine, who are at least 18 years old.

Exclusion Criteria:

* Participants younger than 18 years.

Primary outcomes:
measure: Understanding
timeFrame: 3 months
Secondary outcomes:
measure: Attitudes towards the appropriateness of this type of presentation of health information
timeFrame: 3 months
measure: Health numeracy
timeFrame: 3 months
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University of Split School of Medicine
Study officials:
affiliation: PhD student
name: Ivan Buljan, MPsy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schapira MM, Walker CM, Cappaert KJ, Ganschow PS, Fletcher KE, McGinley EL, Del Pozo S, Schauer C, Tarima S, Jacobs EA. The numeracy understanding in medicine instrument: a measure of health numeracy developed using item response theory. Med Decis Making. 2012 Nov-Dec;32(6):851-65. doi: 10.1177/0272989X12447239. Epub 2012 May 25.
citation: Buljan I, Tokalic R, Roguljic M, Zakarija-Grkovic I, Vrdoljak D, Milic P, Puljak L, Marusic A. Framing the numerical findings of Cochrane plain language summaries: two randomized controlled trials. BMC Med Res Methodol. 2020 May 6;20(1):101. doi: 10.1186/s12874-020-00990-4.
Clinical trial NCT05519852: Pilates Physical Activity in Sickle Cell Disease
Official title: Quality of Life Response to Pilates Physical Activity in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sickle cell anemia (SCA) is a life-threatening hereditary hemoglobinopathy characterized by hemoglobin (Hb) polymerization that affects many people worldwide.Reduced physical capacity is common in people with SCA. Pilates is a form of physical activity that recently used in clinicial practice

Detailed description: SCA patients (40 patients) with ages more than 18 years will join randomly the pilates group (20 patients) or control non exercised group (20 patients). Pilates will be trained 30 minutes (before it there will be warm up period and after it there will be cooldown period , each will be 5 minutes). the pilates will be repeated five sessions per the week for 3 months

Eligibility criteria: Inclusion Criteria:

* sedentary sickle disease patients from both both sexes in medical stable condition

Exclusion Criteria:

* cardiac complaints, pregnant women, patients who smoke or drink alchols

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: It will be measured after 12 weeks
Secondary outcomes:
measure: six minutes walking distance
timeFrame: It will be measured after 12 weeks
measure: quadriceps strength
timeFrame: It will be measured after 12 weeks
measure: hand grip strength
timeFrame: It will be measured after 12 weeks
measure: physical component summary of short-form-36 questionnaire
timeFrame: It will be measured after 12 weeks
measure: mental component summary of short-form-36 questionnaire
timeFrame: It will be measured after 12 weeks
measure: beck depression inventory
timeFrame: It will be measured after 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
affiliation: Lecturer, Cairo University
name: Ali Ismail
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01874652: Assessment of Safety & Efficacy of Light Weight Breast Implant
Official title: Assessment of Safety & Efficacy of Light Weight Breast Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Implants
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-06-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast Implant (LWBI) in breast augmentation.

Detailed description: This is a Single-center. The purpose of the study is to evaluate safety and effectiveness of LWBI in breast augmentation.

Eligibility criteria: Inclusion Criteria:

* Genetic women at ages 18 to 65 seeking breast enlargement
* Signed informed consent
* Agreement to complete all required follow up visits
* A medically acceptable candidate
* Sufficient breast tissue for proper implant coverage (≥20 mm by pinch test)

Exclusion Criteria:

* Patients with active infection anywhere in their body
* Women who are currently pregnant or nursing
* Insufficient tissue covering in the prospective area of implantation (e.g. after preceding breast reduction), radiation damage or reduced vascularization
* Abscesses, malignant tumors(cancer or recurrent metastases), advanced fibrocystic diseases
* Patients with a history of psychiatric treatment
* Patients that been implanted with any silicone implant (e.g. silicone artificial joints, facial implants)
* Expected allergies or extraordinary immune response to implants
* Wound healing impairments or heavy burn scars
* Existing costal injuries
* The Patient Participated in an investigational trial within 30 days of enrollment

Primary outcomes:
measure: No reoperation
timeFrame: during 6 months follow up period
Secondary outcomes:
measure: Duration for all adverse events (AEs) on per patient and per implant basis will be recorded and analyzed.
timeFrame: 6 month
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion
Study officials:
affiliation: Bnai-Zion
name: Noam Calderon, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03733652: Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
Official title: Study on the Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis b
Efficacy, Self
Keywords: Chronic Hepatitis B
entecavir
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 100
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: There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Tenofovir or interferon alfa is the optimal choice right now. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.

Detailed description: There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Poor efficacy is defined as hepatitis b virus DNA is still positive and decreases \> 2 lg from baseline. Sequential therapy by using tenofovir or interferon alfa is the optimal choice right now. 100 patients with poor antiviral efficacy of entecavir will be recruited in this study. They are randomly divided into tenofovir group or interferon alfa group. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.

Eligibility criteria: Inclusion Criteria:

1. Hepatitis b virus DNA or HBsAg positive for over half a year;
2. Age from 18 to 65;
3. With poor efficacy of entecavir: Hepatitis b virus DNA is still positive at 24 weeks, and decrease \> 2 lg from baseline .
4. Not be treated with interferon alfa ever before.

Exclusion Criteria:

1. Other active liver diseases;
2. Cirrhosis, hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions;
7. Patients can not follow-up.

Primary outcomes:
measure: HBsAg decrease after 48 weeks treatment
timeFrame: 48 weeks
Secondary outcomes:
measure: HBsAg clearance after 48 weeks treatment
timeFrame: 48 weeks
measure: Undetectable hepatitis b virus DNA after 48 weeks treatment
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Liang Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: