louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00170885: Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
Official title: Multicenter, Randomized, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: acute rejection
renal function
everolimus
cyclosporine microemulsion
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.


Eligibility criteria: Inclusion Criteria:

* Recipients of deceased, living unrelated, or non-human leukocyte antigen (HLA) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion)
* The renal cold ischemic time must be \< 36 hours.
* The age of the donor must be between 15 and 65 years.

Exclusion Criteria:

* Patients who are recipients of multiple organ transplants, including more than one kidney
* Patients who have previously received an organ transplant which failed within one year
* Patients with current panel reactive T-cell antibody titers of 50% or more
* Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplant

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment
Secondary outcomes:
measure: Pharmacokinetics (PK)
measure: Count of CD4 and CD8 positive lymphocytes
measure: Metabolic control: lipids, glycaemic control, proteinuria, enzymes
measure: Ultrasound ejection fraction
measure: Major adverse cardiovascular events
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Ponticelli C, Salvadori M, Scolari MP, Citterio F, Rigotti P, Veneziano A, Bartezaghi M; EVEREST Study. Everolimus and minimization of cyclosporine in renal transplantation: 24-month follow-up of the EVEREST study. Transplantation. 2011 May 27;91(10):e72-3. doi: 10.1097/TP.0b013e318216c1db. No abstract available.
Clinical trial NCT01677585: Post-Approval Study of PROMUS Element™ in China
Official title: PROMUS Element™ China Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-09-03
Enrollment: 2016
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 subjects who are candidates for coronary artery stenting, signed the informed consent form and eligible to receive a PROMUS Element stent will be evaluated for enrollment in this study.

Brief summary: The purpose of this study is to compile real-world clinical outcomes data for the PROMUS Element™ and PROMUS Element™ Plus Everolimus-Eluting Coronary Stent System (PROMUS Element and PROMUS Element Plus Stent System) in routine clinical practice in China.

Detailed description: Everolimus-eluting stents have been studied extensively in ongoing clinical studies. The safety and effectiveness of the everolimus drug and polymer combination have been studied extensively in the SPIRIT Clinical Trial Program. The PROMUS Element stent is currently being studied in the PLATINUM Clinical Trial Program. The PROMUS Element stent is also being evaluated in PROMUS Element Plus US post-approval studies and the ongoing Platinum China study. This study is designed to provide post-market surveillance information on the PROMUS Element™ and PROMUS Element™ Everolimus-Eluting Coronary Stent System (PROMUS Element and PROMUS Element Plus Stent System) after it has been approved by SFDA (State of Food and Drug Administration) in China. The study will evaluate clinical outcomes for subjects receiving the PROMUS Element and PROMUS Element plus stents over 5 years in a real world setting according to post approval requirements from SFDA.

Eligibility criteria: Inclusion Criteria:

* Subject must be at least 18 years of age
* Subject understands and provides written informed consent
* Subject who is clinically indicated and will have an attempt of at least one PROMUS Element stent OR Subject who is clinically indicated and was implanted with at least one PROMUS Element stent
* Subject is willing to comply with all protocol-required follow-up evaluation

Exclusion Criteria:

* Exclusion criteria is not required in the PROMUS Element China Post-Approval study which is an "all comers" study.

Primary outcomes:
measure: Target Lesion Failure (TLF) rate
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affliated Hosptial Zhejiang University College of Medicine
Study officials:
affiliation: Second Affliated Hosptial Zhejiang University College of Medicine
name: Jian'an Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03783585: Feasibility of Web-based CBT-I Intervention in Individuals With Multiple Sclerosis
Official title: Assessment of the Feasibility of a Web-based CBT-I Intervention to Improve Sleep Quality and Fatigue in Individuals With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Forty individuals with multiple sclerosis (MS) will be randomly assigned to a 6-week web-based cognitive behavior therapy for insomnia intervention (wCBT-I) or to wCBT-I plus biweekly support meetings with research personnel via phone or video. Questionnaires will be used to assess sleep quality, fatigue, and satisfaction. Recruitment, retention, attrition, adherence, and safety information will also be collected. This study is significant because addressing insomnia symptoms through CBT-I could be a low-cost, low-risk, non-pharmacological options for improving sleep quality and MS symptoms in individuals with MS. This study is innovative because CBT-I has never been delivered via a web-based application to individuals with MS which may increase access to services.


Eligibility criteria: Inclusion Criteria:

* 18-80 years old
* diagnosis of MS by physician
* report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 6 months
* ≥10 on Insomnia Severity Index (ISI)
* English speaking
* reports access to internet service and phone
* has a high school diploma to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study.

Exclusion Criteria:

* known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
* \>3 on STOP BANG indicating risk of sleep apnea
* increased risk of restless leg syndrome
* nervous system disorder other than MS
* relapse and/or corticosteroid use in past 8 weeks
* score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorse any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
* performs shift-work.

Primary outcomes:
measure: change in Insomnia Severity Index (ISI)
timeFrame: baseline and week 8
Secondary outcomes:
measure: change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline and week 8
measure: change in Modified Fatigue Impact Scale (MFIS)
timeFrame: baseline and week 8
measure: change in Fatigue Severity Scale (FSS)
timeFrame: baseline and week 8
measure: change in Multiple Sclerosis Impact Scale (MSIS)
timeFrame: baseline and week 8
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Catherine Siengsukon
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Catherine Siengsukon, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00585156: The Effects of Celecoxib on Bone Ingrowth
Official title: The Effects of Celecoxib on Bone Ingrowth in Porous Coated Titanium Ceramic Implants in Humans
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Bone Ingrowth
Pain
Keywords: Celebrex, Bone Ingrowth, Pain relief
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-01-03
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effect of Celebrex on bone growth into porous coated implants, following postoperative total knee arthroplasty administration of Celebrex for pain relief.


Eligibility criteria: Inclusion Criteria:

* Male VA bilateral TKA patients 18 years or older with primary OA diagnosis

Exclusion Criteria:

* Patients with osteoporosis, hypersensitivity to Celebrex, allergy to tetracycline, Sulfonamides, patient with asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs.
* Patients who have had CABG.
* Patients with a history of peptic ulcer disease, duodenal ulcers.
* Female patients and patients diagnosed with unstable hypertension or hypotensive, with serum creative levels above 1.8-2.0 or diagnosed with severe renal disease.

Primary outcomes:
measure: Bone Ingrowth
timeFrame: 12 weeks
Secondary outcomes:
measure: Pain Score
timeFrame: 10 days postoperative
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Veteran Affairs (VA) Medical Center
state: Utah
Study officials:
affiliation: Research Professor, Orthopedic Surgery
name: Roy Bloebaum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hofmann AA, Bloebaum RD, Rubman MH, Bachus KN, Plaster RL. Microscopic analysis of autograft bone applied at the interface of porous-coated devices in human cancellous bone. Int Orthop. 1992;16(4):349-58. doi: 10.1007/BF00189618.
citation: Hofmann AA, Bloebaum RD, Koller KE, Lahav A. Does celecoxib have an adverse effect on bone remodeling and ingrowth in humans? Clin Orthop Relat Res. 2006 Nov;452:200-4. doi: 10.1097/01.blo.0000238838.18799.61.
Clinical trial NCT03373656: Vaccination for Children of H&O and Their Parents
Official title: Study on Compliance, Safety and Effectivity of Vaccination for Children With Hematologic Malignancies or Solid Tumors and Their Parents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaccination
Hematologic Malignancy
Solid Tumor, Childhood
Keywords: Vaccination
Childhood
Hematologic Malignancy
Solid Tumor
Immune Deficiency
Lead sponsor: Children's Cancer Group, China
Sponsor class: NETWORK
Collaborators: name: Shanghai Pudong District Center for Disease Control and Prevention
First posted: 2017-12-14
Enrollment: 300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to study on compliance, safety and effectivity of vaccination for children with hematologic malignancies or solid tumors and their parents.

Detailed description: Children with hematologic malignancies or solid tumors are all facing with immune deficiency due to the disease, the chemotherapy, the hematopoietic stem cell transplantation or the splenectomy, which greatly increases their chance to get infectious diseases. In this study, we will assess the compliance of children with hematologic malignancies or solid tumors and their parents to accept vaccination after finishing treatments, follow up with untoward effect questionnaires to assess the safety, obtain the serum of children patients to test antibody titers and assess the effectivity, provide clues for the study of vaccination in children with hematologic malignancies or solid tumors and provide a scientific basis for the formulation and reunification of vaccination programs.

Eligibility criteria: Inclusion Criteria:

1. Children patients(≤18 years) who accepted chemotherapy, hematopoietic stem cell transplantation or splenectomy since our study started.
2. No history of hepatitis B and measles, do not suffer from other diseases that affect immune function and allergic diseases.

Exclusion Criteria:

1. Children patients who did not reach clinical remission after treatment, critically ill or eventually died.
2. Patients who used monoclonal antibodies, especially anti-tumor necrosis factors.
3. Intermittent or low-dose chemotherapy or other immunosuppressive drugs users.

Primary outcomes:
measure: Number of parents of children willing to be vaccinated after receiving relevant knowledge propagation
timeFrame: 2 years
measure: Number of participants with vaccination-related adverse events
timeFrame: 2 years
measure: The level of serum antibody increased after vaccination
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Yi-Jin Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01310556: Unknown Glucose Metabolism Disorders In Patients With Coronary Artery Disease
Official title: The Relationship Between Previously Unknown Glucose Metabolism Disorders and Coronary Artery Disease in Patients Suffering From Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: OGTT
coronary artery disease
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2011-03-08
Enrollment: 230
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with coronary artery disease and who had no glucose metabolism disorders.

Brief summary: This study aimed to examine the prevalence of glucose metabolism disorders (GMD)in the patients with coronary artery disease and the relationship between different GMDs and coronary artery disease (CAD).

Detailed description: Context: There are more than 220 million people diagnosed with diabetes mellitus (DM) in the world. DM is a serious risk factor for coronary artery disease (CAD). This study aimed to examine the prevalence of glucose metabolism disorders (GMD) in te patients with coronary artery disease and the relationship between different GMDs and CAD.

Settings: 230 patients with coronary artery disease and without any known GMDs were included the study. Coronary angiography was used to diagnose CAD. Patients were administered the 75 g Oral Glucose Tolerance Test (OGTT).

Eligibility criteria: Inclusion Criteria:

* Patients with coronary artery disease and who had no glucose metabolism disorders were included to study.

Exclusion Criteria:

* Patients who had previous GMDs, malignancies, chronic liver and kidney diseases, rheumatologic disorders, and a BMI higher than 35 kg/m2 were excluded from the study.

Primary outcomes:
measure: Frequency of unknown glucose metabolism disorders in patients with coronary artery disease
timeFrame: 1 year
Secondary outcomes:
measure: Fasting and 120 minute glucose levels have relation with vessels' stenosis.
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine
Study officials:
affiliation: Gulhane School of Medicine Ankara/Turkey
name: Aydogan Aydogdu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06827756: Comparative Study of Secondary Prophylaxis for SBP
Official title: Comparative Study Between Norfloxacin, Nitazoxanide and Colistin As Secondary Prophylactic Agents for Spontaneous Bacterial Peritonitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spontaneous Bacterial Peritonitis
Cirrhoses, Liver
Ascites
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if norfloxacin, nitazoxanide, and colistin work as secondary prophylactic agents for spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. It also aims to evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are:

Are nitazoxanide and colistin as effective as norfloxacin in preventing recurrent SBP?

What medical outcomes do participants experience when taking norfloxacin, nitazoxanide, or colistin?

Researchers will compare norfloxacin, nitazoxanide, and colistin to determine their effectiveness in preventing SBP recurrence in cirrhotic patients.

Participants will:

Be randomly assigned to receive either 400 mg norfloxacin daily, 500 mg nitazoxanide twice daily, or 15 ml colistin syrup three times daily (2.25 MIU total per day).

Undergo regular blood tests and ascitic fluid analysis at discharge, 2 months, and 6 months post-treatment.

Be monitored for any side effects and recurrence of SBP.


Eligibility criteria: Inclusion Criteria:

Success Criteria: A ≥50% reduction in CRP within 3 months is considered a positive response.

* Ascitic patients diagnosed with Spontaneous Bacterial Peritonitis (SBP) by paracentesis.
* Ascitic fluid polymorphonuclear (PMN) cell count \> 250/mm³.
* Age 50 years to 80 years.
* Willing to provide informed consent.

Exclusion Criteria:

* Pregnant or breastfeeding females.
* History of allergic reactions to Norfloxacin, Nitazoxanide, or Colistin.
* Patients with recurrent spontaneous peritonitis.
* Presence of gastrointestinal hemorrhage.
* Renal failure (Creatinine \> 2 mg/dL or on dialysis).
* Presence of severe infection-related sequelae (e.g., persistent fever, abdominal discomfort, sepsis).

Primary outcomes:
measure: Recurrence of Spontaneous Bacterial Peritonitis (SBP)
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
measure: C-Reactive Protein (CRP) Reduction
timeFrame: Baseline, 1 month, 3 months, and 6 months
measure: White Blood Cell (WBC) Count Reduction
timeFrame: Baseline, 1 month, 3 months, and 6 months
measure: Renal Function Stability
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
measure: Adverse Events (Safety Assessment)
timeFrame: Throughout study duration (0-6 months)
Locations:
city: Tanta
country: Egypt
facility: Tanta University, Faculty of Medicine
Study officials:
References:
Clinical trial NCT01346956: Acute Cardiovascular Effects of Cigarette Smoking
Official title: Acute Cardiovascular Effects of Cigarette Smoking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Keywords: Cigarette
Smoking
Cardiovascular Effects
2D Echocardiography
Doppler
Lead sponsor: Andhra Medical College
Sponsor class: OTHER_GOV
First posted: 2011-05-04
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty healthy male smokers

Brief summary: Twenty healthy smokers will be subjected to measurement of Pulse, Blood Pressure, electrocardiogram (ECG) and Echo at baseline and after smoking a cigarette. The measurements will be compare for any cardiovascular effects of a cigarette smoking on these parameters.

Detailed description: Twenty male persons habituated to smoking (at least 5 cigarettes/day) will be recruited after an informed consent. Healthy persons with no systemic illness will be included. After a history and a routine examination, subjects will be asked to abstain from smoking for 3 hours and then their pulse, BP, ECG and echo recorded. The measurements will be repeated after 15 min. and the average of these two taken as baseline readings. Then, they will be asked to smoke a cigarette and the measurements taken again. Special focus will be on Doppler measures of left ventricular (LV) function. The measurements are repeated immediately and at 5,10 and 15 min. The data will be analyzed for any cardiovascular effects of smoking a cigarette. Chi square test for proportions and t-test for means will be done. A p value \< 0.05 will be taken as significant.

Eligibility criteria: Inclusion Criteria:

* Healthy male smokers (at least 5 cigarettes /day) \>18 years old.

Exclusion Criteria:

* Any cardiac or respiratory or systemic illness,including hypertension.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Visakhapatnam
country: India
facility: Andhra Medical College
state: Andhra Pradesh
Study officials:
affiliation: Andhra Medical College
name: Venkatachelam R Chitrapu, MD DM
role: PRINCIPAL_INVESTIGATOR
References: