louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04362553: Advanced Wireless, Wearable Sensors for Continuous Hemodynamic Monitoring
Official title: Advanced Wireless, Wearable Sensors for Continuous Hemodynamic Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiology patients

Brief summary: Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring


Eligibility criteria: Inclusion Criteria

1. Patient's aged 18-65
2. Patient's scheduled to undergo a Trans-thoracic Echocardiogram (TTE) in an outpatient cardiology clinic or admitted to the Cardiac Care Unit with a swan ganz catheter in place for continuous invasive hemodynamic monitoring

Exclusion Criteria

1. Patient's with fragile skin or skin conditions that would prevent them from having a sensor placed
2. Patients undergoing exercise or drug induced cardiac stress test
3. Patients with a visible wound at site of sensor placement 3.4. Patients with structural or functional limitations to peripheral blood flow (known upper extremity peripheral arterial disease, use of vasopressors etc.).

Primary outcomes:
measure: Percent agreement with pilot sensor and current standard of vital signs monitoring
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT06568653: Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula
Official title: The Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula in Colorectal Surgery Department of Imam Khomeini Hospital Complex: A Non-randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Fistula Perianal
Keywords: fistula, perianal fistula, non-Crohn's disease, exosome, mesenchymal stem cell, human placenta stem cell
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if human placenta mesenchymal stem cells (MSC)-derived exosomes work to treat complex perianal fistula in adults without Crohn's disease. The safety of this treatment will also be learned. The main questions it aims to answer are:

* Does treatment with MSC-derived exosomes lower the number of fistula recurrences in participants?
* Is treatment with MSC-derived exosomes safe? We will compare treatment with MSC-derived exosomes to the routine treatment which is fistulotomy (surgery to close the fistula) alone to see if MSC-derived exosomes work better to treat complex fistula.

Participants will:

* Undergo fistulotomy plus MSC-derived exosome injections or fistulotomy alone.
* Visit the clinic the week after surgery and then every 4 weeks for checkups and tests


Eligibility criteria: Inclusion Criteria:

* participants with complex perianal fistula
* provided written informed consent

Exclusion Criteria:

* participants with any inflammatory bowel diseases
* pregnant or lactating participants
* participants with contraindications for surgery
* participants with hepatitis
* participants with uncontrolled diabetes
* participants with alcohol or substance abuse

Primary outcomes:
measure: The number of fistula openings (orifices) will be assessed before and after our intervention.
timeFrame: 3 months
Secondary outcomes:
measure: QoL questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00056953: Peer Mentors for Adolescents in HIV Affected Families
Official title: Peer Mentors for Early Adolescents in HIV-Affected Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adolescent Behavior
Health Behavior
HIV Seronegativity
Keywords: health behavior
adolescent behavior
peer mentoring
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-03-27
Enrollment: 160
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effectiveness of a peer mentoring program designed for youths ages 9 to 15 whose parents or guardians are HIV infected. The program will focus on the youths' mental health, school performance, alcohol and drug use, personal and social behaviors, and behaviors that might expose them to HIV. The study is expected to enroll predominantly minority youth.

Detailed description: This study will conduct an efficacy trial of peer mentoring for a high-risk, predominantly minority population of 9- to 15-year-old youths whose parents are HIV infected. The study will also determine mechanisms (mediating variables) through which peer mentoring improves outcomes for the mentees, for example, consistency and continuity of relationship, teaching/role modeling, emotional support/empathy, advocacy, and behavioral reinforcement. After the conclusion of the efficacy trial, the study will continue through naturalistic longitudinal research for an additional 2 years in order to examine the long-term outcomes of peer mentoring.

Participants are randomized to either the peer mentoring program or a control condition (a recreation program). Surveys are conducted at entry into the study, at 6 months, 1 year, and then annually for 2 years. Youths will also participate in focus groups. The surveys and focus groups will assess the youths' psychological functioning, academic adjustment, alcohol and drug use, HIV risk behaviors, delinquent/violent behaviors, peer relationships, prosocial activities, and coping/problem-solving skills. The study will also evaluate family outcomes, including parent/guardian functioning and improved permanency planning.

Eligibility criteria: Inclusion Criteria

* HIV infected parent or guardian
* No previous involvement in the mentoring program
* Adolescent assent
* Parental consent

Primary outcomes:
measure: substance use; association with substance using peers
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Health People
state: New York
Study officials:
affiliation: National Development and Research Institutes, Inc.
name: Stephen Magura, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenblum A, Magura S, Fong C, Cleland C, Norwood C, Casella D, Truell J, Curry P. Substance use among young adolescents in HIV-affected families: resiliency, peer deviance, and family functioning. Subst Use Misuse. 2005;40(5):581-603. doi: 10.1081/ja-200030816.
Clinical trial NCT01094353: A Comparative Study Minisling Versus Transobturator (TOT)Sling
Official title: Randomised Trial of Ophira™ Minisling System and Unitape™ for the Treatment of Stress Urinary Incontinence in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Female Stress Urinary Incontinence
Keywords: Urodynamic Stress urinary incontinence
Minisling
Ophira™
Unitape™
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2010-03-26
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical, prospective, single-center, randomized controlled trial comparing the efficacy and safety of a single-incision mini-sling and a transobturator midurethral sling for female stress urinary incontinence (SUI) treatment.
Primary purpose: TREATMENT

Brief summary: A study to compare efficacy in surgical treatment for SUI (Stress Urinary Incontinence), tot with minisling.

Detailed description: eligibility criteria was : female stress urinary incontinence

Eligibility criteria: Inclusion Criteria:

* clinical and urodynamic diagnosis of SUI in patients between 18 and 90 years

Exclusion Criteria:

* postvoid residual urine volume more than 100 ml, coagulation disorders, current urinary tract infection, sequelae of previous radiation therapy of the pelvis, anticoagulant therapy, vulvovaginitis, and anesthesia contraindication

Primary outcomes:
measure: to assess efficacy between tot with minisling in cure in women with stress urinary incontinence
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Ana LG Pascom, Pg
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Ridder D, Berkers J, Deprest J, Verguts J, Ost D, Hamid D, Van der Aa F. Single incision mini-sling versus a transobutaror sling: a comparative study on MiniArc and Monarc slings. Int Urogynecol J. 2010 Jul;21(7):773-8. doi: 10.1007/s00192-010-1127-z. Epub 2010 Mar 4.
citation: Djehdian LM, Araujo MP, Takano CC, Del-Roy CA, Sartori MGF, Girao MJBC, Castro RA. Transobturator sling compared with single-incision mini-sling for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2014 Mar;123(3):553-561. doi: 10.1097/AOG.0000000000000148.
Clinical trial NCT03082053: A Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours
Official title: A Phase Ib Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced or Metastatic Biliary Tract Cancer
Advanced or Metastatic Solid Tumors
Lead sponsor: ASLAN Pharmaceuticals
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 2 studies of single group in 1 protocol
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore safety and efficacy of varlitinib administered as monotherapy in Japanese subjects with advanced or metastatic solid tumors, and administered as combination with capecitabine in Japanese subjects with advanced or metastatic biliary tract cancer. Also to evaluate pharmacokinetics (PK) of varlitinib, capecitabine and its metabolite.


Eligibility criteria: Inclusion Criteria:

* Study I: Subjects with a solid tumour (excluding haematologic tumors) in advanced or metastatic stage
* Study II: Subjects with advanced (unresectable) or metastatic biliary tract cancer (IHCC, EHCC, gallbladder cancer or ampullary carcinoma)

Exclusion Criteria:

* Subjects with concurrent multiple primary cancers.
* Subjects with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or with a history of interstitial lung disease or current interstitial lung disease
* Subjects receiving proton pump inhibitors for established, symptomatic gastro-duodenal ulceration or gastroesophageal reflux disease (including the preventive use)

Primary outcomes:
measure: The number of patients with a dose limiting toxicity (DLT) in the first treatment cycle
timeFrame: 3 weeks
measure: Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) or Recommended Phase II Dose (RP2D) in Phase I setting.
timeFrame: 52 weeks
Secondary outcomes:
measure: Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Peak Plasma Concentration (Cmax)
timeFrame: Through, Day 1, Day 3, Day 22
measure: Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Area under the plasma concentration-time curve (AUC) from 0 to 12 hours (AUC0-12)
timeFrame: Through, Day 1, Day 3, Day 22
measure: Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Minimum (trough) plasma concentration (Cmin)
timeFrame: Through, Day 1, Day 3, Day 22
measure: Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Elimination half-life of Phase β (t1/2β)
timeFrame: Through, Day 1, Day 3, Day 22
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: ASLAN Selected sites
Study officials:
References:
Clinical trial NCT05147753: Moxonidine Effects on Neuropeptide Y
Official title: Effects of Moxonidine Administration on Serum Neuropeptide Y Levels in Hypertensive Individuals: A Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Hypertension
Keywords: hypertension
obesity
Neuropeptide Y
moxonidine
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment with monotherapy of moxonidine 0.6 mg daily in treatment-naïve subjects with mild or moderate hypertension

Detailed description: Treatment with 0.6 mg moxonidine daily in treatment-naïve subjects with mild or moderate hypertension according to guidelines (Stage 1: Systolic Blood Pressure =140-159 mmHg, Diastolic Blood Pressure =90-99 mmHg, and Stage 2: systolic blood pressure=160-179 mmHg, diastolic blood pressure=100-109 mmHg) that require monotherapy and reevaluation after 12 weeks

Eligibility criteria: Inclusion Criteria:

* treatment-naïve subjects with mild or moderate hypertension according to Joint National Committee 7 and European Society Hypertension / European Society Cardiology 2008 (Stage 1: Systolic Blood Pressure =140-159 mmHg, Diastolic Blood Pressure =90-99 mmHg, and Stage 2: Systolic=160-179 mmHg, Diastolic=100-109 mmHg) that require monotherapy

Exclusion Criteria:

* age beyond 25-75 years,
* not taking currently anti-hypertensive medication
* not taking anti-diabetic or lipid lowering medication and other diseases or conditions that may influence blood pressure, heart rate and catecholamines' and Neuropeptide Y levels, including anemia, fever, stage III hypertension, coronary artery disease, recent (less than 6 months) myocardial infraction or stroke, heart failure, secondary hypertension, diabetes mellitus, abnormal thyroid status or other obesity-related endocrinopathies, pregnancy, kidney failure, alcohol abuse, malignancies, depression or other psychiatric illnesses, such as schizophrenia,

Primary outcomes:
measure: serum Neuropeptide Y levels
timeFrame: 12 weeks
measure: systolic blood pressure
timeFrame: 12 weeks
measure: diastolic blood pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: Weight
timeFrame: 12 weeks
measure: Body Mass Index
timeFrame: 12 weeks
measure: Total Cholesterol
timeFrame: 12 weeks
measure: HDL Cholesterol
timeFrame: 12 weeks
measure: LDL Cholesterol
timeFrame: 12 weeks
measure: Serum triglycerides
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AHEPA University Hospital
name: Eleni Karlafti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00704353: Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
Official title: A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of a Single Dose of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia in Subjects Who Are Not Dialysis Dependent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-24
Enrollment: 735
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: The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent


Eligibility criteria: Inclusion Criteria:

* Subjects ≥18 years of age and able to give informed consent
* Iron deficiency is the primary etiology of anemia
* Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL
* Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 when TSAT was ≤30%

Exclusion Criteria:

* Previous participation in a FCM trial
* Known hypersensitivity reaction to FCM
* Requires dialysis for treatment of chronic kidney disease
* Current anemia not attributed to iron deficiency
* Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
* Anticipated need for surgery requiring general anesthesia 30 days prior to screening or during the study period
* AST of ALT greater than 1.5 times the upper limit of normal
* Received an investigational drug within 30 days of screening
* Pregnant or sexually-active females who are not able to use an effective form of birth control

Primary outcomes:
measure: Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)
timeFrame: through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02633553: Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
Official title: An Open-label, Multi-center, Randomized Phase III Study of Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thymoma
Keywords: thymoma
adjuvant radiotherapy
complete resection
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate whether adjuvant radiotherapy after complete resection has a better survival for stage II or III thymoma.

Detailed description: It is confirmed by many studies that patients of thymoma with complete resection have better prognosis than those with either incomplete resection or without surgery. However,whether patients with stage II or III thymoma could benefit from adjuvant radiotherapy after complete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiotherapy after complete resection can improve survival for stage II or III thymoma.

Eligibility criteria: Inclusion Criteria:

18\~75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed masaoka stage II or III thymoma; Have adequate bone marrow, hepatic, and renal function; Patients receive complete resection within 3 months; Written informed consent.

Exclusion Criteria:

Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.

Primary outcomes:
measure: DFS (Disease free survival)
timeFrame: 5 years
Secondary outcomes:
measure: OS(overall survival)
timeFrame: 5 years
measure: Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Kailiang Wu
state: Shanghai
Study officials:
References:
Clinical trial NCT04218253: Clinical Application of Nutrition Support Package Before Hepatectomy
Official title: Clinical Application of Preoperative Nutritional Support Package for Liver Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Neoplasms
Nutrition Therapy
Hepatectomy
Keywords: Nutrition Therapy
Hepatectomy
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Objective:To confirm the effect of preoperative oral nutrition therapy on patients with malnourished before liver cancer resection.

Study design:Prospective, randomized, controlled clinical study. Primary end point: incidence of all complications 30 days after surgery.


Eligibility criteria: Inclusion Criteria:

* 1. Clinical diagnosis of primary liver cancer (including hepatocellular carcinoma, bile duct carcinoma, and mixed cell carcinoma)
* 2. No contraindications for surgery
* 3. Eastern Cooperative Oncology Group (ECOG) score of preoperative physical state \<2 points
* 4. Preoperative liver function score Child-Pugh ≤ 6 points: total bilirubin ≤ 3.0 mg / dl, albumin ≥ 28 g / L, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 5 times the upper limit of normal
* 5. Voluntarily enter the study and sign the informed consent form, and communicate well with the researcher

Exclusion Criteria:

* 1. Patients who took fish oil supplements within 3 weeks before the study began
* 2. Patients with severe nutritional risk: serious nutritional risk should be considered when combining any of the following conditions: weight loss \> 10% within 6 months; digital pain score (NRS) score \> 5 points; BMI \<18.5 kg/m2 (all patients with severe nutritional risk undergo individualized supportive care);
* 3. Patients with malignant tumors in other parts
* 4. Patients who are pregnant or lactating
* 5. Patients with mental and neurological disorders who cannot cooperate with medical staff
* 6. Patients with severe diabetes or poor glycemic control
* 7. Patients cannot tolerate nutritional preparations
* 8. Other circumstances that the researcher considers inappropriate to participate in the study

Primary outcomes:
measure: Incidence of complications at 30 days after surgery
timeFrame: up to 30 days after surgery
Secondary outcomes:
measure: Postoperative hospital stay
timeFrame: up to 90 days after surgery
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University cancer Instituteand Hospital
Study officials:
affiliation: Tianjin Medical University cancer Instituteand Hospital
name: Kun Wang, Doctor
role: STUDY_CHAIR
References: