louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04881708: Post-Surgical Based Efforts to Reduce Preventable Readmissions and Optimize Length of Stay
Official title: Post-Surgical Based Efforts to Reduce Preventable Readmissions and Optimize Length of Stay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators believe that hospital readmissions for intermediate- to high-complexity surgeries can be reduced by remote patient monitoring follow-up post-discharge, which involves daily touchpoints with a clinical nurse, vital sign evaluation and a symptom directed communication escalation process.


Eligibility criteria: Inclusion Criteria:

* Adults (over 18 years of age)
* Undergoing one of the following inpatient elective surgery procedures: abdominal wall reconstruction, bariatrics, hepatectomy, pancreatectomy, aortic surgery, lower extremity bypass, esophagectomy and colectomy at Mayo Clinic Rochester.
* Must be willing to actively work with RPM nurses with vital sign capturing.

Exclusion Criteria:

* Have uncontrolled mental illness and/or drug or alcohol abuse
* Reside in a long-term care facility
* Are being actively followed by dialysis or transplant services
* Pregnant
* Are being actively treated for cancer, receiving chemo or radiation therapy during the remote monitoring
* Are identified as end-of-life by provider
* Have dementia, cognitive impairment, or physical condition that limits ability to use home remote monitoring equipment independently or interact with remote patient monitoring staff (unless a caregiver commits to assisting daily).

Primary outcomes:
measure: Length of Stay
timeFrame: Until hospital discharge, typically 3 to 7 days
Secondary outcomes:
measure: 30-day readmission rates
timeFrame: 30 day
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Janani Reisenauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00526708: Crestor RUSH (The Efficacy of RosUvaStatin for Korean Dyslipidemia Patients With Hypertension )
Official title: RUSH (Evaluating the Efficacy of RosUvaStatin for Korean Dyslipidemia Patients With Hypertension in Real World Practice)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Hypertension
Keywords: dyslipidemia
hypertension
rosuvastatin
efficacy
Naturalistic
Observational
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hypertensive hypercholesteromia patients in Korean tertiary care centers

Brief summary: To evaluate the efficacy of rosuvastatin in Korean dyslipidemia patients with hypertension.


Eligibility criteria: Inclusion Criteria:

* Hyperlipidemia patients who are prescribed with rosuvastatin 10mg, based on clinical grounds and fulfil the following criteria

  1. Over 18 years of age
  2. Currently or previously diagnosed with hypertension and receiving medical care

Exclusion Criteria:

1. Patients already taking other hyperlipidemic agents
2. Patients who do not fulfil the indication criteria for statin therapy
3. Patients who do not have baseline and/or follow-up lipid data to verify the efficacy data

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Jongro-gu
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Kangnam-gu
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Songpa-gu
Study officials:
affiliation: AstraZeneca Korea
name: Hyunah Caroline Choi
role: STUDY_DIRECTOR
References:
Clinical trial NCT00005508: Determinants of Coronary Disease in High Risk Families
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To define factors contributing to coronary heart disease (CHD) in high risk families.

Detailed description: DESIGN NARRATIVE:

The study followed healthy siblings of patients diagnosed with CHD before age 60. All siblings underwent comprehensive risk factor screening and exercise thallium tomography to identify occult CHD. Follow-up was performed from 6-15 years after entry (mean 8.7 years) to determine the incidence of (1) acute coronary events (sudden death, myocardial infarction, and unstable angina) and (2) progression of occult CHD (repeat exercise thallium tomography). Blood was obtained for genomic DNA, which was tested for polymorphisms of candidate genes which may be associated with premature thrombotic CHD events (platelet proteins GPIIB/IIIa\[PlA1/A2 and Baka/b\] and GPIbB, endothelial nitric oxide synthase, angiotensin converting enzyme, angiotensinogen, D-fibrinogen, plasminogen activator-1, and methylenetetrahydrofolate reductase). Plasma levels of proteins implicated in the pathogenesis of atherosclerosis and thrombotic CHD events were measured (fibrinogen, plasminogen activator inhibitor-1, tissue plasminogen activator, homocysteine, lipoprotein (a), and apo(a) isoform size). DNA was also obtained from living probands and affected siblings to use for genetic linkage studies using affected and unaffectedsibling pairs. Statistical analyses examined (1) whether selected genetic polymorphisms were linked to the occurrence of acute CHD events, and (2) to what extent traditional sociodemographic and biological coronary risk factors or new genetic polymorphisms explained the progression of occult CHD, or the transition from occult to symptomatic CHD events in families with premature CHD.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Lewis Becker
References:
Clinical trial NCT02088008: A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination Tablet With Coadministration of Cilnidipine and Valsartan
Official title: A Randomized, Open-label, Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combination of Cilnidipine 10mg and Valsartan 160mg in Comparison to Each Component Coadministered in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 54
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single dosing, two-way crossover clinical trial to compare the safety/tolerability and pharmacokinetics of the combination of Cilnidipine 10mg and Valsartan 160mg in comparison to each component coadministered in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 40
* Signed informed consent

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypertension or hyportension

Primary outcomes:
measure: AUClast
timeFrame: 0~24hrs
measure: Cmax
timeFrame: 0~24hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03044808: Investigation of the Effect of Intravenous Lidocaine Infusion on Postoperative Pain Treatment and Bowel Function in Robotic Bowel Surgery
Official title: Randomized Double Blind Prospective Investigation of the Effect of Intravenous Lidocaine Infusion on Postoperative Pain Treatment and Bowel Function in Robotic Bowel Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Use
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 randomized groups, one getting lidocaine and the other getting saline
Primary purpose: TREATMENT

Brief summary: Single center double blind randomised controlled trial. 60 subjects. Giving lidocaine IV or saline to patients due to robot assisted colorectal surgery. Primary outcome is cumulative morphine consumption at 24 hours.

Detailed description: Prospective double blind randomised controlled trial. The investigators are giving lidocaine IV or saline to 60 patients undergoing robot assisted colorectal surgery. Blinding and randomization is done by the hospital pharmacy. Both groups get otherwise the same treatment and a IV PCA (patient controlled administration) morphine pump for objectivisation of opioid consumption. Other outcome measures are NRS (numerical rating score) pain score, PONV (postoperative nausea and vomiting), use of antiemetics and opioid consumption up to 72 hours.

Eligibility criteria: Inclusion Criteria:

* all patients due to robotic laparoscopic colorectal surgery, \> 18years of age, danish speaking

Exclusion Criteria:

* allergy to lidocain or amid local analgetics, atrioventricular blok, liver- and/or kidney failure, chronic use of opioids or NSAIDS, pregnancy, breastfeeding women, treatment with betablockers, porphyria

Primary outcomes:
measure: Reduction in morphine consumption
timeFrame: over the first 24 hours
Secondary outcomes:
measure: PONV
timeFrame: up to 72 hours
measure: Reduction in morphine consumption
timeFrame: over the first 72hours
measure: Use of antiemetics postoperative
timeFrame: first 72 hours
measure: Time to bowel function
timeFrame: first 72 hours
measure: time to discharge
timeFrame: up to 72 hours
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense Universitetshospital
Study officials:
References:
citation: Herzog J, Schou M, Jensen KM, Lauridsen JT, Jensen AG. A randomised controlled trial of lidocaine infusion on post-operative opioid consumption in patients undergoing robotic colorectal surgery. Dan Med J. 2020 Jan;67(1):A06190342.
Clinical trial NCT01855308: Single Site Robotic Cholecystectomy in Non Selected Patients
Official title: Single Site Robotic Cholecystectomy in Non Selected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholelithiasis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are referred to the surgery program with non-emergency gallbladder disease, for which cholecystectomy is indicated, will be given the opportunity to participate. Referred patients typically come from the primary care setting. The demographic composition of the study population will depend in the patient referred to the program.

Brief summary: This is a study of new technology to allow gallbladder removal through a single small surgical incision. A surgical robot is utilized to help navigate the small space. In this study, patient characteristics are broad to assess how applicable the procedure is to everyone.


Eligibility criteria: Inclusion Criteria:

* presence of symptomatic gallstones

Exclusion Criteria:

* significant previous open abdominal surgery

Primary outcomes:
measure: Completion of procedure by SSRC
timeFrame: At time of surgery
Secondary outcomes:
measure: Adverse events to study participants (e.g. bile duct injury, hemorrhage)
timeFrame: At time of procedure and in clinic up to 30 days after surgery
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: UC Davis
name: Mohamed R Ali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05825508: PedBot Ankle Rehablitation
Official title: PedBot Ankle Rehabilitation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cerebral Palsy
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by Physical Medicine and Rehab with cerebral palsy

Brief summary: The primary objective of the study is to determine engagement with use and adherence to a home exercise program with our PedBotHome ankle rehabilitation device. We will place the device in the home for 90 days and consider the study a success if used for at least 30 minutes a day for at least 3 days a week during this period.

Detailed description: The major secondary objective is to determine if the range of motion of the ankle has improved through use of PedBotHome. Other secondary objectives will measure ankle strength and control.

Secondary outcomes will include a measurable increase in range of motion across the ankle joint (in any direction) and a measurable increase in strength in plantarflexion, dorsiflexion, inversion, and eversion. Improvement in gait and speed of ambulation will also be considered secondary outcome measures as an indication of better ankle control.

Eligibility criteria: Inclusion Criteria:

* Cerebral palsy

Exclusion Criteria:

* Healthy volunteers

Primary outcomes:
measure: number of days used
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
References:
Clinical trial NCT02323308: Isolated Anti-HBc Serological Profile in HIV Infected Patients: Immunological, Virological Characteristics and Response to Hepatitis B Vaccination
Official title: Study of Immunological, Virological, Serological Characteristics of HIV+ Patients Harboring Isolated Anti-HBc Profile and Response to Hepatitis B Vaccination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Hepatitis B
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2014-12-23
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HIV infection and presenting with "isolated anti-HBc" profile. HBV vaccination is recommended fot these patients.

Brief summary: The aim of study is to describe the clinical, immunological, serological, virological and therapeutic characteristics of HIV+ patients harboring isolated anti-HBc profile and to assess the response to vaccination in these patients.


Eligibility criteria: Inclusion Criteria:

* HIV+ adults patients
* negative HBsAg
* negative a-HBs Ab
* positive HBc Ab
* without HBV - vaccination
* CD4 cell above 200 /mm3
* HIV viral load below 50 copies/mL

Exclusion Criteria:

* positive HBs antigenemia in the past
* transaminitis above fivefold upper normal limit
* PT\<50% or Platelet \<50 000/mm3
* ongoing opportunistic infection
* ongoing or recent systemic corticoid or immunomodulatory therapy, splenectomy, pregnancy, contra-indication to intramuscular injection, familial history of neurological disease.

Primary outcomes:
measure: Evaluation of immunological, virological and serological characteristics associated to "anti-HBc isolated" profile
timeFrame: at Day 0, inclusion visite
measure: Average titers of anti-HBs Ab
timeFrame: at 4 weeks, 28 weeks and 18 months after the first vaccination HBV
measure: Analysis of B-cell phenotype and maturation
timeFrame: at baseline and at week 28
Secondary outcomes:
measure: Number of patients with HBsAb titers as protective titer>10 IU/L
timeFrame: at 4 weeks,28 weeks and 18 month after the first dose HBV vaccin
measure: Detection of IgG+ memory B cells specific for HBcAg or HBs Ag
timeFrame: at baseline and 28 weeks after the first dose HBV vaccin
measure: - Detection of HBV preS2 and S-specific T cells
timeFrame: at day 0 and week 28
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon
Study officials:
affiliation: CHU DIJON
name: Lionel Piroth
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03572608: Pregnancy Success Rates of Acupuncture for in Vitro Fertilization
Official title: Clinical Effectiveness of Acupuncture to Increase Pregnancy Success Rates for Women Undergoing in Vitro Fertilization: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Female
Keywords: acupuncture
infertility
pregnancy
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of acupuncture on pregnancy success before embryo transfer in IVF treatment in female infertile patients. Half of participants will receive acupuncture sessions before embryo transfer, while the other half will not receive.

Detailed description: Acupuncture is used for many health problem all around the World. WHO reported that acupuncture can have benefit in female infertility treatment. However, there is no enough evidence about effectiveness of acupuncture treatment in the infertility.

Eligibility criteria: Inclusion Criteria:

* To have unexplained infertility
* To go in vitro fertilization treatment
* To give permission by informed consent form

Exclusion Criteria:

* Below age of 18 and above age of 45
* To have secondary infertility
* To reject completing informed consent form

Primary outcomes:
measure: pregnancy
timeFrame: 2 weeks after the treatment
Secondary outcomes:
measure: Anxiety level
timeFrame: Through study completion, 2 weeks after the protocol
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Hospital
Study officials:
affiliation: Ataturk University
name: Bunyamin Borekci
role: STUDY_CHAIR
References:
Clinical trial NCT03436108: Bisphenol Role in the Pathogenesis of PCOS
Official title: Role of Bisphenol A (BPA) in the Pathogenesis of the Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PCOS
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
name: Cairo University
First posted: 2018-02-19
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: females who were diagnosed to have PCOS

Brief summary: Polycystic ovary syndrome (PCOS) is the most common and the most heterogeneous endocrine disorder in premenopausal women. Its prevalence is estimated from 5 to 10% depending on the diagnosis' criteria .

Apart from signs of hyperandrogenism such as acne, hirsutism and hair loss; women with PCOS usually present with menstrual irregularities and fertility problems ..

Detailed description: Bisphenol A is formed from acetone and phenol, it is used in production of epoxy resin, polyster resins and polyvarbonate resins. Epoxy resins are used in plastics, adhesives, and structural composites .

Humans are at the end of the food chain, thus they are exposed to the highest doses of these compounds. EDs have been detected in human adipose tissue and biological fluids such as: serum, urine, milk and amniotic fluid .

Additionally, it has been proven that BPA can also directly stimulate androgen synthesis in the ovarian theca-interstitial cells. A correlation between increased serum testosterone levels observed in women with PCOS with serum BPA concentrations has also been found .

Eligibility criteria: Inclusion Criteria:

* Age group: 18-40
* Females
* Diagnosed a case of polycystic ovary syndrome

Exclusion Criteria:

* • Female patients with other acute or chronic illness

  * Cardiovascular disease
  * Neoplasms
  * Current smoking, diabetes mellitus,
  * Renal impairment (serum creatinine 120 mol/liter), and hypertension (blood pressure 140/85 mm Hg).

Primary outcomes:
measure: the number of participants who will have high level of bisphenol in btheir blood
timeFrame: within 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt )
name: Mahmoud Alalfy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05158608: Comparison of PT-Cy at a Dose of 25 mg/kg/Day and PT-Cy at a Dose of 50 mg/kg/Day in GVHD Prophylaxis
Official title: A Randomized, Open-label, Single-center Study Comparing Cyclophosphamide at a Dose of 25 mg/kg/Day and Cyclophosphamide at a Dose of 50 mg/kg/Day in Graft Versus Host Disease Prophylaxis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Graft Versus Host Disease
Hematologic Malignancy
Cyclophosphamide Adverse Reaction
Keywords: Allogeneic transplantation
Graft-versus-host-disease prophylaxis
Post-transplant cyclophosphamide
Lead sponsor: National Research Center for Hematology, Russia
Sponsor class: NETWORK
First posted: 2021-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a two arm open label phase III clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from any donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity conditioning regimen of fludarabine, busulfan (treosulfan). Patients will receive PTCy at different dose (25 mg/kg/day vs 50 mg/kg/day on day +3,+4 in combination with calcineurin inhibitors and mofetil mycophenolate) as GvHD prophylaxis.


Eligibility criteria: Inclusion Criteria:

* Patients who have an indication for allogeneic hematopoietic stem cell transplantation

Exclusion Criteria:

* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent

Primary outcomes:
measure: Incidence of acute graft-versus-host disease, grades II-IV
timeFrame: 180 days
measure: Incidence of chronic GVHD, moderate and severe (NIH criteria)
timeFrame: 365 days
Secondary outcomes:
measure: Overall survival analysis
timeFrame: 365 days
measure: Event-free survival analysis
timeFrame: 365 days
measure: Non-relapse mortality analysis
timeFrame: 365 days
measure: Incidence of graft failure and poor graft function
timeFrame: 365 days
measure: Incidence of 30-Day Readmission
timeFrame: 365 days
Other outcomes:
Locations:
Study officials:
affiliation: National Research Center for Hematology
name: Elena Parovichnikova, MD, D.Sc
role: PRINCIPAL_INVESTIGATOR
References: