louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01470326: Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
Official title: Viviant®20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: Osteoporosis
Post menopausal women
SERM
Japanese
Viviant
Regulatory Post Marketing Commitment Plan
Long term treatment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-11
Enrollment: 3187
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects whom an investigator involving B1781007 prescribes the Bazedoxifene Tablets.

Brief summary: In this survey, to collect the safety and efficacy information of Bazedoxifene in daily medical practice will be examined. In addition, the necessity of special Investigation and post-marketing clinical studies will be examined, while investigating unexpected adverse drug reactions during the survey period and understanding of the status of frequency of adverse drug reactions in daily medical practice.

Detailed description: All the subjects whom an investigator prescribes the first Bazedoxifene (Viviant) Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria: Inclusion Criteria:

* Post menopausal women subjects with Osteoporosis who has no experience of use of Bazedoxifene.

Exclusion Criteria:

* Subject with present or past venous thromboembolism such as deep venous thrombosis, pulmonary embolism, or retinal venous thrombosis
* Subject in long-term immovability (postoperative recovery, long-term bed rest)
* Subject with antiphospholipid antibody syndrome

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 3 years
measure: Number of Participants With Any Fracture
timeFrame: 3 years
Secondary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
timeFrame: 3 years
measure: Number of Participants With Treatment-Related Adverse Events by Age
timeFrame: 3 years
measure: Number of Participants With Treatment-Related Adverse Events by Smoking Status
timeFrame: 3 years
measure: Number of Participants With Treatment-Related Adverse Events by Use of Steroid
timeFrame: 3 years
measure: Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication
timeFrame: 3 years
measure: Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04899726: Description of the Safety and Functionality of a Rectoscope (P201630551)
Official title: Description of the Safety and Functionality of a Rectoscope (P201630551) That Allows the Identification of the Distal Section Margin in Oncological Rectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oncological Rectal Surgery
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot Study
Primary purpose: OTHER

Brief summary: Most patients with rectal cancer receive neoadjuvant therapy. This usually causes a decrease in tumor size. In approximately 20% of patients who receive neoadjuvant therapy, the tumor disappears completely (complete pathological response), showing as a scar on the rectal mucosa, not noticeable from the rectal serosa, from outside the rectum, difficulting the identification of the tumor location by the surgeon.

Rectoscope (p201630551) allows the surgeon to view the illuminated rectum from the patient's abdomen, determining the appropriate point of section of the rectum.


Eligibility criteria: Inclusion Criteria:

* Men and women over 18 years old.
* Patients with rectal cancer (15 cm or less from the anal margin), whether or not they have received neoadjuvant treatment, in whom cancer surgery is to be performed through the anterior (abdominal) route, whether laparoscopic or not.
* Patients who accept their participation in this study, after explaining the study details.
* Patients who sign the informed consent.

Exclusion Criteria:

* Patients who are going to undergo an abdominoperineal amputation or transanal surgery for rectal cancer.
* Patients who do not accept their participation in this study.

Primary outcomes:
measure: Number of adverse events related to use of the device.
timeFrame: at immediate postoperative period
measure: Evaluation of functionality
timeFrame: at surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References:
Clinical trial NCT01115426: Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis
Official title: Long-term Treatment by Inhibitors of Angiotensin II at Low Doses in Non-nephrotic Proteinuric Patients With Pauciimmune and IgA Mesangioproliferative Glomerulonephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: IGA Glomerulonephritis
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates prospectively the effects of an anti-angiotensin II regimen on renal outcome in patients with mesangioproliferative glomerulonephritis followed-up for 10 years.

Detailed description: After signing informed consent, enrolled patients started treatment with ACEi. We decided to prescribe to all patients the same drug (ramipril) at the same dosage (5 mg/day). All patients were examined every 2 months during the first year of follow-up and every 6 months thereafter. At each visit, they underwent a complete physical examination. If the target blood pressure of \<140/90 mmHg was not achieved with ramipril monotherapy, addition of other antihypertensive drug(s) was allowed. Patients complaining adverse side effects attributed to ramipril were switched to losartan (50 mg/day). The patients were also prescribed a normal protein (1 gram/kg/day) and moderately salt-restricted (6-8 grams/day) diet throughout the study.

Eligibility criteria: Inclusion Criteria:

* proteinuria ≥ 1 g and \< 3 g/24 hours stable during the 3 months of run-in
* microscopic hematuria (with at least 10 red blood cells per high-power field), without other signs or symptoms of systemic diseases stable during the 3 months of run-in
* no-evidence of renal failure or other relevant diseases
* biopsy diagnosis of I-II stage IgA- or pauciimmune-MsPGN

Exclusion Criteria:

* estimated Glomerular Filtration Rate (eGFR) \<80 ml/min/1.73m2
* previous immunosuppressive treatment
* blood pressure (BP) \>150/90 mmHg

Primary outcomes:
measure: renal function and proteinuria
timeFrame: at the end of first year of observation
Secondary outcomes:
measure: serum levels of creatinine
timeFrame: at the end of first years of observation
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: "Mater Domini" Hospital
state: Calabria
Study officials:
affiliation: "Magna Graecia" University of Catanzaro, Nephrology Unit
name: Giorgio Fuiano, Professor
role: STUDY_CHAIR
References:
citation: Presta P, Minutolo R, Iodice C, Comi N, Casoria V, Fuiano L, Caglioti C, Conte G, Fuiano G. Renin-angiotensin system inhibitors reduce the progression of mesangioproliferative glomerulonephritis: 10 year follow-up. Eur J Intern Med. 2011 Dec;22(6):e90-4. doi: 10.1016/j.ejim.2011.08.021. Epub 2011 Sep 28.
Clinical trial NCT04191226: Genetic Mutation in Recurrent Cervical Cancer
Official title: Overall Perspective on the Characteristics of Genetic Mutation in Recurrent Cervical Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Cervical Cancer
Nucleotide Variant
Copy Number Variation
Insertion-deletion Variation
Genomic Structural Variation
Total Mutation Burden
Microsatellite Instability
PD-1
PD-L1
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 300
Sex: FEMALE
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: Patients of pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma, and aged 18 years or older

Brief summary: Little is known about the characteristics of genetic mutation in recurrent cervical cancer. This study is to explore the targeted genetic mutations via a multi-gene panel, which consists of more than 500 hundred genes. The mutation characteristics are to be revealed in single nucleotide variants, copy number variations, insertion-deletion variations, and genomic structural variations. The total mutation burden (TMB) will be calculated. The status of microsatellite instability, expression of PD-1 and PD-L1 antibodies are also tested. These findings will be studies in association with the patients' prognosis and sensitivity to platinum-based chemotherapy and immunotherapy.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma
* With available materials for analysis
* With detailed clinicopathological information
* Given consent to participate the trial

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Frequency of genetic mutations
timeFrame: Two years
Secondary outcomes:
measure: Total mutation burden
timeFrame: Two years
measure: Frequency of microsatellite Instability
timeFrame: Two years
measure: Expression rates of PD-1 and PD-L1 antibodies
timeFrame: Two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03445026: Frequency of Hypodontia After Chemotherapy in Childhood Cancer Survivors Study
Official title: Frequency of Hypodontia After Chemotherapy in Childhood Cancer Survivors: A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypodontia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 144
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be selected from 57357 Children Cancer Hospital records according to inclusion and exclusion criteria and contacted to attend.

Brief summary: This study aims to provide information on the frequency of hypodontia in children cancer survivors receiving chemotherapy before 4 years of age.Patients who met the eligibility criteria will be given a structured questionnaire to fill followed by a radiographic examination (dental panorama) for confirmation and standardization of the results.


Eligibility criteria: Inclusion Criteria:

* Aged 4 years or less when they first started their antineoplastic chemotherapy
* Both genders
* Able to cooperate

Exclusion Criteria:

* Children with known family history of hypodontia
* Children with any associated developmental anomalies (eg, ectodermal dysplasia, cleft lip or palate and Down syndrome)
* Children who received radiotherapy
* Children with previous loss of teeth due to trauma, caries, periodontal disease or extraction 5- Children who received bone marrow transplantation 6-Parents/patients unwilling to give informed consent

Primary outcomes:
measure: Hypodontia
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT01631526: Vitamin D Loading Dose in Advanced Lung Cancer
Official title: Open Clinical Trial to Validate a Short-term Vitamin D Loading and Maintenance Dose Protocol in People With Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
vitamin D
pharmacokinetics
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypovitaminosis D is highly prevalent in people with lung cancer, and may have adverse clinical consequences. The long and variable pharmacokinetic half-life of vitamin D makes prompt vitamin D replacement problematic. This is an open, one-armed therapeutic intervention using a loading dose of vitamin D that will be predicted to increase plasma 25-hydroxyvitamin D concentrations of every patient well into the normal range (\> 100 nmol/L) within 2 or 3 weeks and monitored after 2 and 3 weeks of loading and maintenance dose. Preliminary data will also be obtained to identify potentially clinical important outcome benefits for future investigation. The outcomes are

1. plasma 25OHD concentration
2. Vitamin D binding protein and other plasma concentrations
3. Mood and symptom


Eligibility criteria: Inclusion Criteria:

1. Any patient with advanced lung cancer whether or not receiving specific anti-cancer therapy
2. Mentally competent (but need not be fluent in French or English if capable neutral translator available)
3. Self report of reduced food intake and/or involuntary weight loss of any extent at time of enrollment: does not have to be documented

Exclusion Criteria:

1. Current diagnosis of primary hyperparathyroidism
2. Nephrocalcinosis
3. Current or suspected active tuberculosis, histoplasmosis, sarcoidosis, or other granulomatous disease
4. Current using a vitamin D supplement providing \> 1000 IU/day
5. Current prescribed calcitriol in any dose
6. History of extensive sunlight exposure (\> 30 min summer sunlight exposure per day for more than 5 days per week) in previous 3 months
7. Expected to die within next 2 months
8. Pregnancy

Primary outcomes:
measure: Plasma 25-hydroxyvitamin D concentration
timeFrame: 3 weeks
Secondary outcomes:
measure: Mood
timeFrame: 3 weeks
measure: Symptoms
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Brojde Lung Cancer Centre, Jewish General Hospital
state: Quebec
Study officials:
References:
citation: Hoffer LJ, Robitaille L, Swinton N, Agulnik J, Cohen V, Small D, Pepe C, Eintracht S. Appropriate vitamin D loading regimen for patients with advanced lung cancer. Nutr J. 2016 Oct 6;15(1):84. doi: 10.1186/s12937-016-0203-8.
Clinical trial NCT05499026: Safety and Efficacy of CDCA in CTX Chenodeoxycholic Acid (CDCA) in Patients Affected by Cerebrotendinous Xanthomatosis (CTX)
Official title: Retrospective Cohort Study to Investigate the Safety and Efficacy of Chenodeoxycholic Acid (CDCA) in Patients Affected by Cerebrotendinous Xanthomatosis (CTX)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrotendinous Xanthomatoses
Lead sponsor: Leadiant Biosciences Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-12
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CTX patients

Brief summary: Retrospective study of CTX patients to investigate the safety and clinical efficacy of Chenodeoxycholic Acid


Eligibility criteria: Inclusion Criteria:

Diagnosis of CTX Received treatment with CDCA Age between 2 and 75 years Having at least one cholestanol level and/or urinary bile alcohol level no more than 3 months prior to treatment with CDCA and one cholestanol level and/or urinary bile alcohol level post-treatment within 2 years from the beginning of therapy with CDCA

Exclusion Criteria:

-

Primary outcomes:
measure: Serum Cholestanol Levels
timeFrame: 34 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02925026: Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Enteric Dysfunction
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Malawi
First posted: 2016-10-05
Enrollment: 235
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children


Eligibility criteria: Inclusion Criteria:

* children aged 12-35 months
* youngest eligible child in each household

Exclusion Criteria:

* severe or moderate acute malnutrition
* severe chronic illness
* children unable to drink 20 mL of dual sugar solution
* children in need of acute medical treatment for illness or injury at time of enrollment

Primary outcomes:
measure: Dual Sugar Absorption Test
timeFrame: 8 weeks
measure: Dual Sugar Absorption Test
timeFrame: 16 weeks
Secondary outcomes:
measure: Lactulose Excretion
timeFrame: 8 weeks
measure: Lactulose Excretion
timeFrame: 16 weeks
measure: Mannitol Excretion
timeFrame: 8 weeks
measure: Mannitol Excretion
timeFrame: 16 weeks
Other outcomes:
measure: Linear Growth
timeFrame: 16 weeks
Locations:
city: Blantyre
country: Malawi
facility: Malawi
Study officials:
affiliation: Washington University in St. Louis; University of Malawi
name: Mark J Manary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Director
name: Chrissie Thakwalakwa, PhD
role: STUDY_DIRECTOR
affiliation: Washington University in St. Louis; University of Malawi
name: Indi Trehan, MD MPH DTM&H
role: STUDY_DIRECTOR
References:
citation: Cheng WD, Wold KJ, Benzoni NS, Thakwalakwa C, Maleta KM, Manary MJ, Trehan I. Lactoferrin and lysozyme to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for a randomized controlled trial. Trials. 2017 Nov 6;18(1):523. doi: 10.1186/s13063-017-2278-8.
Clinical trial NCT03318926: Increased Tea Consumption is Associated With a Decreased Risk of Renal Stone Disease in a Taiwanese Population
Official title: Increased Amount and Time of Tea Consumption is Associated With a Decreased Risk of Renal Stone Disease in a Taiwanese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Stone
Keywords: tea, cup-year, renal stone disease
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 13842
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: examinees who were ≥ 18 years old and underwent health check-ups with abdominal sonography at the health examination center of National Cheng Kung University Hospital

Brief summary: The objective of the this study was to examine the amount and duration of tea consumption in relation to the risk of renal stone disease.

Detailed description: Previous studies have investigated the association between tea consumption and renal stone disease, but the results are still unclear. Besides, the impact of the duration of tea consumption has not yet been investigated in the aforementioned studies. The present study was conducted as a retrospective research to investigate the relationship between both tea consumption amount and time and renal stone disease. Information on tea consumption was obtained by four closed-ended questions in questionnaires, and the diagnosis of renal stones was established on the results of abdominal sonography.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old

Exclusion Criteria:

* individuals with a history of hyperuricemia or gout at baseline, findings of abdominal ultrasound showing transplant kidney, only one kidney, or gouty nephropathy, or missing data

Primary outcomes:
measure: Renal stone diseases
timeFrame: health check-ups from June 2001 to August 2009
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03422926: ChildObesity180 - Social Marketing Campaign to Encourage Healthful Eating in Restaurants for Children
Official title: ChildObesity180 - Social Marketing Campaign to Encourage Healthful Eating in Restaurants for Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Overnutrition
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 2646
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a messaging campaign affects the calories ordered for and consumed by children in a quick serve restaurant setting.

Detailed description: ChildObesity180 seeks to develop and implement a messaging campaign informed by evidence-based behavioral theory as well as perspectives from parents, children, and the restaurant industry. The campaign aims to help parents choose healthful options for their children when dining in the quick-serve restaurant setting. Aim 1 is campaign development. Aims 2 and 3 are assessment (i.e., Randomized controlled trial and revenue analysis). Hypotheses are that the messaging campaign will be associated with fewer calories ordered/consumed by children in the quick serve setting; and the campaign will not negatively impact quick serve restaurant revenue.

Eligibility criteria: Inclusion Criteria:

* Parent or legal guardian of a 4 - 12 year old child (who is present)
* Have not participated in the study before
* \<\<Intervention community only\>\> live, work, or frequently travel to community

Exclusion Criteria:

-

Primary outcomes:
measure: kilocalories ordered
timeFrame: change from baseline to follow-up 3-5 months later
measure: kilocalories consumed
timeFrame: change from baseline to follow-up 3-5 months later
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tufts University
name: Christina D Economos, PhD
role: PRINCIPAL_INVESTIGATOR
References: