louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01807390: Perspectives of Receiving Open Versus Minimally Invasive Surgery
Official title: Perspectives for Receiving Open Versus MIS (PROMIS) - Patients' Perspectives on Surgical Treatment of Lung and Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Esophageal Cancer
Keywords: Minimally invasive surgery
Patient perspectives
Lung cancer
Esophageal cancer
Pain
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 200
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: Patients at the Ottawa Hospital General Campus who are surgical candidates for lung or esophageal cancer over the age of 18.

Brief summary: This study will examine the perspectives of patients' undergoing surgery for lung or esophageal cancer. It will examine both pre-op and post-op patient perspectives and opinions regarding pain and surgical complications. This study will also assess a general health related quality of life pre-op and post-op. Additionally, it will examine the importance of receiving care close to home and their support system.

Hypotheses:

1. The data will allow investigators to better understand the willingness of patients to participate in prospective, randomized studies comparing minimally invasive and open thoracic surgery. Patients will not be willing to undergo randomization to an open versus minimally invasive surgical procedure.
2. The pain associated with Minimally Invasive Surgery (MIS) will be perceived and documented as lesser than open surgery.
3. Patients may be willing to accept a higher risk of complications or more post-operative pain if they were given the option to be cared for closer to their home.


Eligibility criteria: Inclusion Criteria:

* Patients who are surgical candidates for lung or esophageal cancer (entered at pre-op time point)

Exclusion Criteria:

* Below 18 years of age.

Primary outcomes:
measure: Change in pain perceptions
timeFrame: Baseline, 4 weeks and 6 months
Secondary outcomes:
measure: Change in general health related quality of life
timeFrame: Baseline, 4 weeks and 6 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Sebastien Gilbert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05810090: The Outcomes of Subject After Total Knee Arthroplasty
Official title: Functional Outcomes After Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Satisfaction, Patient
Keywords: Total Knee Arthroplasty (TKA)
Western Ontario and McMaster Universities Arthritis Index
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 631
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data were collected from CCH2000 / TKA clinical pathway databank retrospectively.

Brief summary: Total Knee Arthroplasty (TKA) is a standard of intervention for severe knee osteoarthritis, also been proven with benefits in improving pain, mobility, and quality of life. However, the outcomes after TKA is controversial.

Detailed description: Total Knee Arthroplasty (TKA) clinical pathway provides preoperative education, postoperative rehabilitation, and routine outpatient follow-up. The overall functional performance of the patient was assessed. The aim of this study was to analyze (1) clinical pain relief, anxiety reduction and functional recovery after TKA; (2) factors affecting individual functional recovery, such as age, gender, BMI, etc.

The results can be used as a reference for improving the quality in TKA patients.

Eligibility criteria: Inclusion Criteria:

* unilateral knee TKA

Exclusion Criteria:

* bilateral knee TKA

Primary outcomes:
measure: Changes of Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Baseline: date of surgery (day 0); discharge from hospital (D/C), an average of 1 week; 1 month after D/C; 3 months after D/C; 6 months after D/C
measure: Changes of knee Range of motion (ROM)
timeFrame: Baseline: date of surgery (day 0); discharge from hospital (D/C), an average of 1 week; 1 month after D/C; 3 months after D/C; 6 months after D/C
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
affiliation: Changhua Christian Hospital
name: Chung-Che Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02329990: Effect of Phosphorus Supplementation on Body Weight
Official title: Premeal Phosphorus Supplementation for Reducing Energy Intake and Body Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Keywords: phosphorus intake
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Phosphorus is a mineral that is naturally present in our foods and is required by our bodies for normal function. It has been found that phosphorus supplementation taken before meals has the potential to reduce meal size. However its long term effect has not been measured yet. It is well accepted that changes in body weight require about 3 months. Using body weight as the outcome, which is the ultimate outcome of weight loss approaches, would provide robust information on the role of phosphorus.

Detailed description: A double-blind, randomised, placebo-controlled trial of 63 adults aged 18 to 45 years with a body mass index (BMI) of 25 kg/m2 or higher and normal kidney function at the American University of Beirut. Participants were randomly assigned to the placebo or phosphorus group where daily placebo or phosphorus supplements were ingested with three main meals (breakfast, lunch, and dinner) for a period of 12 weeks. Primary outcomes were changes in anthropometric measures, blood metabolites (including lipid profile, glucose, and insulin), and subjective appetite scores.

Eligibility criteria: Inclusion Criteria:

* BMI\>25
* CR\>1mg/dl for women; Cr \>1.2 mg/dl for men
* GFR \>60ml/min/1.73m2

Exclusion Criteria:

* BMI\<25
* presence of any significant medical disease,
* pregnancy or lactation,
* regular administration of drugs that affect body weight, and
* weight loss of 3% or more within 3 months of study entry.

Primary outcomes:
measure: Body Weight
timeFrame: 3 months
Secondary outcomes:
measure: Waist Circumference
timeFrame: 3 months
measure: Appetite Score on the Visual Analog Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AUB
name: Omar Obeid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ayoub JJ, Samra MJ, Hlais SA, Bassil MS, Obeid OA. Effect of phosphorus supplementation on weight gain and waist circumference of overweight/obese adults: a randomized clinical trial. Nutr Diabetes. 2015 Dec 21;5(12):e189. doi: 10.1038/nutd.2015.38.
Clinical trial NCT05498090: Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males with Klinefelter Syndrome
Official title: Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males with Klinefelter Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Klinefelter Syndrome
Keywords: Klinefelters
XXY
47, XXY
Klinefelter's Syndrome
Klinefelter
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-08-11
Enrollment: 44
Sex: MALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arms in study: cross-sectional (cases v. controls); interventional (cases only: pre and post fenofibrate intervention)
Primary purpose: OTHER

Brief summary: This study will learn more about how the body uses energy. Usually, the body uses sugars as energy first and then fats are used when the sugar stores are gone. Some people have trouble using fats as energy. This can lead to feeling tired, difficulty exercising, and storing too much fat where it does not belong (like in the muscle). It is believed that some boys and men with Klinefelter Syndrome may not be able to use fats as energy normally, and that a medication called fenofibrate could help this.


Eligibility criteria: Inclusion Criteria:

* Male
* Ages 15 to 40 years
* Total testosterone concentration within the normal range for age and pubertal stage
* For the KS group only: genetic testing results confirming KS

Exclusion Criteria:

* Liver disease (ALT or AST \> 3x upper limit of normal)
* Renal impairment (estimated creatinine clearance \<80 ml/min)
* Diabetes mellitus (A1c \> 6.4%)
* Untreated hypogonadism
* Treatment with a PPAR agonist (including fish oil) or statin within the past month
* Unstable medications with any medication added or removed within the past 2 weeks or plan for medication changes during the study period
* Inability to tolerate study procedures, including any medical conditions that make exercise unsafe at the discretion of the study physician
* For the KS group only: known allergy to fibrates, inability to swallow tablets

Primary outcomes:
measure: maximal rate of fat oxidation
timeFrame: 1 month
measure: skeletal muscle fat oxidation
timeFrame: 1 month
Secondary outcomes:
measure: differentially-expressed genes in plasma
timeFrame: 1 month
measure: differentially-expressed genes in skeletal muscle tissue
timeFrame: 1 month
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado - Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Shanlee M Davis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04806490: Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome
Official title: Establish and Validate Study of Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Yin Deficiency Syndrome
Keywords: standard scale
syndrome differentiation
Yin Deficiency Syndrome
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: China Academy of Chinese Medical Sciences
name: Affiliated Hospital of Nanjing University of Chinese Medicine
name: Beijing University of Chinese Medicine
First posted: 2021-03-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the subjects were enrolled continuously in the TCM outpatient department. If the informed consent of the researcher is obtained, the scale measurement of the study subjects can be carried out.

Brief summary: An version of the standard scale for syndrome differentiation of Yin Deficiency Syndrome is not available yet for Chinese medicine.

The aim of this study is to develop and validate the standard scale for syndrome differentiation of Yin Deficiency Syndrome. The study is divided into two steps. The first step is to develop the standard scale for syndrome differentiation of Yin Deficiency Syndrome through expert consultation (Delphi method). The second step is to apply the scale in the participants and find out the diagnostic cut-off value of the scale by comparing it with the gold standard.


Eligibility criteria: Inclusion Criteria:

* Subject will be recruited from the current outpatients' clinic activity of the affiliated hospitals of Beijing University of Chinese Medicine and Nanjing University of Chinese Medicine. Subjects must be able to read and write in Chinese. After obtained informed consent we will ask them to participate to this study.
* All the subjects need to fill in the scale of Yin Deficiency syndrome and be diagnosed by a specialist in traditional Chinese medicine (TCM) to determine whether they have Yin deficiency syndrome. The judgment of TCM experts is the gold standard.

Exclusion Criteria:

* Participates who not meet eligibility criteria

Primary outcomes:
measure: the diagnostic cut-off value of scale
timeFrame: 12 months
Secondary outcomes:
measure: Accuracy of the Standard Scale for Syndrome Differentiation of Yin Deficiency Syndrome
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References:
Clinical trial NCT00516490: GnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: GnRH agonist
IVF/ICSI outcome
luteal phase
Lead sponsor: V.K.V. American Hospital, Istanbul
Sponsor class: OTHER
First posted: 2007-08-15
Enrollment: 570
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single dose GnRH agonist administration in the luteal phase of assisted reproduction cycles was reported to increase pregnancy and birth rates. This study was done to evaluate the reproducibility of previous findings.

Detailed description: GnRH agonist administration in the luteal phase was reported to beneficially affect clinical outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles stimulated with the long GnRH agonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist protocol were included. In addition to routine luteal phase support with progesterone women were randomized to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing pregnancy rate was the primary outcome measure.

Eligibility criteria: Inclusion Criteria:

* Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist protocol, oocyte pick-up and ICSI.
* Embryo transfer performed on day 3.

Exclusion Criteria:

* Participation in another trial that was being conducted in our unit at the same time.
* Preimplantation genetic screening cycles.
* Day 5 embryo transfers.

Primary outcomes:
measure: Ongoing pregnancy rate beyond 20 weeks
Secondary outcomes:
measure: Clinical pregnancy
measure: Embryo implantation rate
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Amerikan Hastanesi Tüp Bebek Merkezi
Study officials:
affiliation: The Assisted Reproduction Unit of the American Hospital of Istanbul
name: Baris Ata, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Assisted Reproduction Unit of the American Hospital of Istanbul
name: Bulent Urman, M.D.
role: STUDY_DIRECTOR
References:
citation: Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Hum Reprod. 2006 Oct;21(10):2572-9. doi: 10.1093/humrep/del173. Epub 2006 Aug 22.
citation: Ata B, Yakin K, Balaban B, Urman B. GnRH agonist protocol administration in the luteal phase in ICSI-ET cycles stimulated with the long GnRH agonist protocol: a randomized, controlled double blind study. Hum Reprod. 2008 Mar;23(3):668-73. doi: 10.1093/humrep/dem421. Epub 2008 Jan 12.
Clinical trial NCT01332890: Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects
Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Drug interaction
revaprazan
Itopride HCI
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate drug-drug interaction

Detailed description: The main objective is to evaluate the pharmacokinetic profile of the 50mg Revaprazan plus 50mg Itopride compared to 50mg Revaprazan or 50mg Itopride alone in healthy Korean subjects

Eligibility criteria: Inclusion Criteria:

* Males aged 20 to 50 years old, with a body mass index (BMI) between 19 and 27 kg/m2
* Acceptable medical history, physical exam,laboratory tests and EKG, during screening
* Eligible for blood sampling during study period
* Provision of signed written informed consent

Exclusion Criteria:

* History of any clinically significant disease
* History of drug/chemical/alcohol abuse
* Clinically significant illness or within 30days before the first dose
* Use of medication known to chronically alter drug absorption or elimination processes within 30days before the first dose of investigational product
* Use of prescribed medication during the 14 days before administration of the first dose of investigational product
* Use of any non-prescribed medication during the 7 days before administration of the first dose of investigational product - Use of any oriental medication medication during the 30 days before administration of the first dose of investigational product
* Participated in a clinical study involving administration of an investigational drug (new chemical entity) or a marketed drug within past 90 days
* Consuming more than 21 units of alcohol per week
* Smoking more than 20 cigarettes per day or consuming more than 5 cups of caffeinated beverages.

Primary outcomes:
measure: Pharmacokinetics
timeFrame: Blood sampling will be obtained on day 7 at each period.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center, University of Ulsan
Study officials:
References:
Clinical trial NCT01743690: The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus
Official title: The Use of Probiotics in Patients With Symptomatic Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Lichen Planus
Candida Infection
Keywords: Probiotic
Candida
Oral Lichen Planus
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 25
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 aim is to investigate the effect of probiotic bacteria on symptoms and clinical manifestations in patients with oral lichen planus (OLP).

The hypothesis is that probiotic bacteria can favor an oral environment that reduces the risk of symptomatic candidal and bacterial infection in OLP.

The negative influence of improper oral hygiene on OLP is established and overgrowth of Candida is a common problem. Nystatin is the only topical antifungal that does not interact with other drugs and to which the majority of the candida species are susceptible. Symptomatic treatment with fluocinolone is initiated in patients without candidal infection. Probiotic bacteria can affect the microbial homeostasis by reducing the overgrowth of pathogens e.g. candida. Different probiotic species have been shown to produce antifungal substances and reduce the growth of candida albicans in vitro. The probiotic strain Lactobacillus rhamnosus has been found to reduce the salivary count of yeasts among elderly in a randomized clinical study.

The study is planned as a blinded, randomized controlled study with four parallel arms. 120 OLP patients with symptoms form the mucous membranes are included in the study and will receive nystatin or fluocinolone treatment depending on positive or negative diagnosis of candidosis. In addition, they will be assigned to either the probiotic (A) or the placebo group (B) by randomization. The groups will be encouraged to take three tablets per day (morning, noon and evening)for eight weeks. The lozenges containseither two strains of the probiotic bacterium L. reuteri (A) or placebo (B). Cytosmears, saliva sample, and saline mouth wash will be taken at baseline, after the treatment period and at follow-up visits at 8, 16, 24 weeks and 1 year. Salivary counts of the probiotic strains, the clinical manifestations and symptoms associated to OLP will be recorded.


Eligibility criteria: Inclusion Criteria:

* Symptomatic Oral Lichen Planus

Exclusion Criteria:

* Antibiotic treatment within 3 months

Primary outcomes:
measure: recurrence of candida infections
timeFrame: after 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Mette K Keller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01484990: A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease
Official title: A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
levodopa
carbidopa
Duodopa
intestinal gel
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2011-12-05
Enrollment: 19
Sex: ALL
Minimum age (years): 30
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced Parkinson's Disease.


Eligibility criteria: Inclusion Criteria

1. Male or female subjects at least 30 years old;
2. Subjects with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days;
3. Body mass index range from 18.0 to 30.0 kg/m2

Exclusion Criteria

1. Subjects who are considered to be violent or subjects considered at suicidal risk by the investigator;
2. Clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments;
3. Subjects with serious symptomatic cerebral disease, cerebrovascular disease, focal neurological lesions (previous brain surgery), any acute brain trauma requiring treatment with anticonvulsant therapy, or acute stroke

Primary outcomes:
measure: Profile of Pharmacokinetics
timeFrame: 5mins, then every 30 minutes up to 8 hours (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8 hour), 12, 16 (immediately after flushing the tube), 17, 18, and 19 hours.
measure: Safety and Tolerability Data Assessments (e.g., clinical laboratory tests, orthostatic vitals, adverse events assessment, physical exam)
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Janet Benesh
role: STUDY_DIRECTOR
References:
citation: Nyholm D, Odin P, Johansson A, Chatamra K, Locke C, Dutta S, Othman AA. Pharmacokinetics of levodopa, carbidopa, and 3-O-methyldopa following 16-hour jejunal infusion of levodopa-carbidopa intestinal gel in advanced Parkinson's disease patients. AAPS J. 2013 Apr;15(2):316-23. doi: 10.1208/s12248-012-9439-1. Epub 2012 Dec 11.