louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06687421: Implementation of Precision Medicine in High-risk Prostate Cancer
Official title: Swedish Prostate Cancer Initiative for Novel Treatment Regimens - Real, Implementation of Precision Medicine in High-risk Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Region Västerbotten
Sponsor class: OTHER_GOV
Collaborators: name: Umeå University
First posted: 2024-11-13
Enrollment: 5500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All men who come for biopsy as a part of the investigation for suspected prostate cancer will be invited to participate.

Brief summary: This project's objective is to initiate a prospective non-interventional clinical study to perform full molecular characterization and subtyping of the primary tumor prostate cancer patients.

It will identify, compare, and select biomarkers for treatment response in high-risk/metastatic prostate cancer.

Detailed description: This prospective study includes molecular characterization of the primary tumor, biobanking of urine and blood, questionnaires, collection of health economic parameters, cross-checking of registries to link both other diagnoses and drug use to the different biomarkers and socio-economic parameters.

Clinical variables including imaging and routine pathology and the outcome of the molecular diagnostic analysis should, in addition to the basic scientific purpose, also be able to identify men who may be eligible for other studies, both pharmaceutical company-funded and investigator-initiated studies.

One aim is also to develop the national medical information system already in place for prostate cancer (individual patient record) with molecular profiling and other variables for health estimation, health economics and also enable retrieval from more registries.

This study will form the basis for the start of a nationwide study with the aim to prioritize biomarkers for the development of treatment predictive algorithms

Eligibility criteria: Inclusion Criteria:

* Men investigated for suspected prostate cancer
* Signed consent form

Exclusion Criteria:

* Difficulties understanding information about the study due to linguistic, cognitive or other reason

Primary outcomes:
measure: Failure-free survival
timeFrame: From enrollment to 20 years failure-free survival
Secondary outcomes:
measure: Biomarker profiling
timeFrame: From enrollment to 20 years.
measure: EORTC QLQ-C15-PAL
timeFrame: From enrollment to 20 years.
measure: IPSS
timeFrame: From enrollment to 20 years
measure: Costs for implementing precision medicine
timeFrame: Before and after implementation of precision medicine workflows
measure: Cost effectiveness analysis
timeFrame: From enrollment to 20 years
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Urology, Umeå University Hospital, Region Västerbotten
Study officials:
References:
Clinical trial NCT03880721: By Developing a Radiomics Model to Predict the Prognosis of Patients With Hepatocellular Carcinoma After Microwave Ablation
Official title: By Developing a Radiomics Model to Predict the Prognosis of Patients With Hepatocellular Carcinoma After Microwave Ablation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: radiomics
prognosis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with primary hepatocellular carcinoma

Brief summary: Developing a radiomics model to predict the prognosis of patients with hepatocellular carcinoma after microwave ablation to provide advice for their treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with primary hepatocellular carcinoma in the department of interventional ultrasound, PLA general hospital, who accept MWA therapy for HCC

Inclusion criteria:

1. Primary hepatocellular
2. No other treatments ware performed before microwave ablation
3. Patient has been clinically diagnosed with HCC definitely, and have a definite operational indication
4. No extrahepatic manifestations and no evidence of vessel invasion and bile duct thrombi

Exclusion Criteria:

* Exclusion criteria:

  1. Non-primary hepatocellular carcinoma or hepatic metastases
  2. Accept other treatment before microwave ablation
  3. Extrahepatic metastasis, vessel invasion or bile duct thrombi

Primary outcomes:
measure: AUC value
timeFrame: through study completion, an average of 2 year
measure: Sensitivity
timeFrame: through study completion, an average of 2 year
measure: Specificity
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00552721: Physical Therapy After Anti-spastic Treatment in Children With Cerebral Palsy
Official title: Physical Therapy With Versus Without Strength Training After Botulinum-toxin Treatment in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Motor control
Spasticity
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2007-11-02
Enrollment: 14
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is the primary purpose of this pilot study to investigate if physical therapy with strength training is better at improving muscle and gait function after anti-spastic treatment with Botulinum toxin compared to physical therapy without strength training in children with cerebral palsy. The investigators hypothesize that it is.


Eligibility criteria: Inclusion Criteria:

* cerebral palsy (diplegia and hemiplegia)
* indication for anti-spastic treatment with Botulinum toxin

Exclusion Criteria:

* fixed contractures

Primary outcomes:
measure: Three-dimensional gait analysis
timeFrame: 12 weeks
measure: Selective motor control
timeFrame: 12 weeks
Secondary outcomes:
measure: Spasticity (modified Ashworth)
timeFrame: 12 weeks
measure: Range of motion
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital
Study officials:
affiliation: Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital
name: Thomas Bandholm, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital
name: Stig Sonne-Holm, MD, DSc
role: STUDY_CHAIR
affiliation: Institute of Exercise and Sport Sciences, University of Copenhagen
name: Bente R Jensen, PhD
role: STUDY_CHAIR
affiliation: Hvidovre University Hospital
name: Søren A Pedersen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01869621: Study of Metformin Pharmacogenetics in Twins
Official title: The Relation Between Heritability and the Trough Concentration of Metformin in Plasma Under Steady-state in Twins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The trough concentration of metformin will be examined in monozygotic and dizygotic twins. Current twin study will determine the total weight of genetics on the trough concentration of metformin.


Eligibility criteria: Inclusion Criteria:

* Age 18-40 years
* Both twins has to be included
* Dizygotic twin pairs has to be same sex
* Informed consent given
* Healthy condition

Exclusion Criteria:

* Chronical/daily alcohol abuse
* Hypersensitivity to metformin
* Ingestion of drugs containing topiramate or x-ray contrast fluids
* For women: Positive pregnancy test/breastfeeding at the beginning of the trial. No use of safe anticonceptives

Primary outcomes:
measure: Heritability
timeFrame: After 6 days of metformin treatment
Secondary outcomes:
measure: Single nucleotide polymorphisms (SNPs)
timeFrame: After 6 days treatment with metformin
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Clinical Pharmacology
Study officials:
References:
Clinical trial NCT01035021: Neuromuscular Block in Laryngeal Mask Airway(LMA) Insertion
Official title: Effect of Neuromuscular Blockade on the Insertion of ProSeal™ Laryngeal Mask Airway and Postoperative Pharyngolaryngeal Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Breast Disease
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2009-12-18
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the success rate, insertion time and complication depending on the use of neuromuscular blocking agent when inserting the laryngeal mask airway (LMA).


Eligibility criteria: Inclusion Criteria:

* 18-70 year
* american society of anesthesiologist status 1-2
* elective general anesthesia

Exclusion Criteria:

* known or predicted difficult airway
* recent sore throat
* mouth opening less than 2.5 cm
* at risk of aspiration

Primary outcomes:
measure: success rate and insertion time
timeFrame: when laryngeal mask airway is inserted
Secondary outcomes:
measure: complication after the remove of LMA - bleeding, sore throat
timeFrame: 1 hour after the LMA is removed
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyoseok Na, Pf
role: PRINCIPAL_INVESTIGATOR
References:
citation: Na HS, Jeon YT, Shin HJ, Oh AY, Park HP, Hwang JW. Effect of Paralysis at the Time of ProSeal Laryngeal Mask Airway Insertion on Pharyngolaryngeal Morbidities. A Randomized Trial. PLoS One. 2015 Aug 7;10(8):e0134130. doi: 10.1371/journal.pone.0134130. eCollection 2015.
Clinical trial NCT00534521: Posterior Tibial Nerve Stimulation vs. Sham
Official title: Posterior Tibial Nerve Stimulation vs. Sham
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: overactive bladder
posterior tibial nerve stimulation
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The overall goal of this research is to determine the efficacy of a sham for posterior tibial nerve stimulation (PTNS). This novel design is needed in order to have a sham treatment that is similar to the actual treatment. The PTNS is used to treat urgency and frequency in people with overactive bladder (OAB). Until research is done using a sham component, we are unable to ascertain if the current use of PTNS is due to a placebo effect.

Detailed description: Subjects will be healthy volunteers who are recruited by word of mouth. At their office visit with the Nurse Practitioner (NP), the subject's history and medication list will be reviewed.

The NP will randomize subjects into groups: one group with the PTNS on the right and sham on the left; the other group with the PTNS on the left and sham on the right. There will be a maximum of 30 subjects tested, and up to 50 people screened. The subjects will have 1 session for the testing of the PTNS vs sham that will include 15 minutes of stimulation as noted below. All participants will be blinded to the therapy they receive as described below.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects \>18 years of age
* Female subjects will be menopausal, or have had a tubal ligation or hysterectomy.
* Capable of giving informed consent
* Capable and willing to follow study related procedures

Exclusion Criteria:

* Pregnancy
* InterStim
* Bion
* TENS
* The subject is deemed unsuitable for enrollment in this study by the investigators based on their history or physical examination (including bleeding disorders)

Primary outcomes:
measure: The objective of this study is to determine the efficacy of a sham for posterior tibial nerve stimulation (PTNS).
timeFrame: Prospective
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03831321: The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
Official title: The Effect of Preemptive Analgesia On The Comfort Of Patient and Doctor, in Cystoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bladder Cancer
Benign Prostate Hyperplasia
Hematuria
Pain
Lower Urinary Tract Symptoms
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 144
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was designed as a prospective, randomized double-blind placebo controlled trial. According to power analysis in regards of previous studies in the literature with diclofenac sodium, using a total of 144 patients are needed for Power: 80% and Efficacy: 0.05. diclofenac (20 mg) and placebo drugs to be used in the study will be numbered 1 and 2 individually. Patient randomization was performed using random.org in 144 patients. On the day of cystoscopy, the patient randomized according to inclusion criteria will be given a medication package corresponding to the number given in randomization. It will not be known by the staff and cystoscopy will be performed by the physician who does not know which package is an effective drug.

Parameters:

1. Visual Pain Score during cystoscopy
2. Cystoscopy comfort - a questionnaire to be filled by the doctor

   1. Excellent
   2. Very good
   3. Good
   4. Bad
   5. Too bad
3. Cystoscopy: Is it efficient? Not efficient? - Will be answered by the doctor.

Post-Op:

1. 1st hour Visual Analog Pain Scale inquiry, dysuria, frequency
2. 24th Hour dysuria, Frequency,

A total of 144 patients, we plan to arrive at the end of 1 month.


Eligibility criteria: Inclusion Criteria:

* Accepted to participate
* 18-70 years old
* Men

Exclusion Criteria:

1. Previous peptic ulcer
2. Gastro intestinal bleeding in advance
3. Renal failure
4. Liver failure
5. Patients who underwent cystoscopy for taking or inserting Double J stents 6 - Drug allergies

7- Patients under 18 8- Patients receiving antiaggregant and antiplatelet therapy 9- Patients who do not agree to participate in the study

Primary outcomes:
measure: Assesment for operational pain
timeFrame: 1 minute
Secondary outcomes:
measure: Assesment of doctors comfort for the procedure(cystoscopy)
timeFrame: 1 minute
measure: Assesment of qualification of cystoscopy
timeFrame: 1 minute
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medeniyet University
state: Outside U.S./Canada
Study officials:
affiliation: Medeniyet University
name: Asıf Yıldırım
role: STUDY_DIRECTOR
References:
Clinical trial NCT00005721: Retaining Donors and Increasing Donation Frequency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Donors
Lead sponsor: Bloodworks
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To retain individuals as blood donors once they have entered the voluntary blood donation system and to increase the frequency of their donations.

Detailed description: BACKGROUND:

The study continued research previously funded as part of a National Research and Demonstration Center (NRDC) in Transfusion Medicine.

DESIGN NARRATIVE:

There were six components to the study. The first identified significant factors influencing regular blood donations by individuals with different donation histories - first-time, second-time, committed (frequent), and lapsed donors. The second component developed and assessed the validity of behavioral models to increase donor retention and to predict whether first and second time donors would contribute again. The third developed donor-retention interventions, especially for the first and second time donors. The fourth component identified homogeneous subgroups among first, second and committed donors who might be receptive to different types of intervention strategies to increase the frequency of their donations. The fifth component evaluated the success of cost-effectiveness of the new interventions compared to existing blood center maintenance strategies. The sixth identified whether or not donors had a limit or ceiling on how often they donated per year.

The investigators drew on two related social psychological theories to combine cognitive and behavioral approaches to blood donor retention and to use the findings to construct a multiattribute model of donor decision-making. A behavioral decision model was used to predict donor behavior prospectively and to target and direct the design of interventions to increase donor retention and the frequency of donations.

Approximately 33 percent of the total project supported the subproject on retaining donors.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bloodworks
name: Tracy Bier
References:
citation: Meyer D, Bolgiano DC, Sayers M, Price T, Benson D, Slichter SJ. Red cell collection by apheresis technology. Transfusion. 1993 Oct;33(10):819-24. doi: 10.1046/j.1537-2995.1993.331094054618.x.
citation: Bolgiano DC, Smith S, Slichter SJ. Strategies to recruit plateletpheresis donors from a registry of HLA-typed, unrelated, bone marrow donors. Transfusion. 1993 Aug;33(8):675-8. doi: 10.1046/j.1537-2995.1993.33893342751.x.
Clinical trial NCT00143221: Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)
Official title: A Multicenter, Randomized, Parallel Group, Double-blind, Placebo-controlled Flexible Dose Study With and Open-label Extension to Assess the Efficacy and Safety of Viagra (Sildenafil Citrate) in the Treatment of Men With Erectile Dysfunction (ED) and Concomitant Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) in the United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impotence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 350
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Viagra is effective in treating erectile dysfunction and lower urinary tract symptoms in men affected by both conditions.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of erectile dysfunction (ED)
* lower urinary tract symptoms (LUTS)

Exclusion Criteria:

* previous prostate surgery or invasive intervention for BPH
* active urinary tract disease

Primary outcomes:
measure: Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo
Secondary outcomes:
measure: Effect on: IPSS Effect on IPSS QoL Orgasmic Function
measure: Sexual Desire Intercourse Satisfaction and Overall Satisfaction domains of IIEF Qmax by uroflometry
measure: Event Log Variables
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: McVary KT, Siegel RL, Carlsson M. Sildenafil citrate improves erectile function and lower urinary tract symptoms independent of baseline body mass index or LUTS severity. Urology. 2008 Sep;72(3):575-9. doi: 10.1016/j.urology.2008.04.020. Epub 2008 Jul 2.
citation: McVary KT, Kaufman J, Young JM, Tseng LJ. Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension. Int J Clin Pract. 2007 Nov;61(11):1843-9. doi: 10.1111/j.1742-1241.2007.01585.x. Epub 2007 Sep 20.
citation: McVary KT, Monnig W, Camps JL Jr, Young JM, Tseng LJ, van den Ende G. Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double-blind trial. J Urol. 2007 Mar;177(3):1071-7. doi: 10.1016/j.juro.2006.10.055.
Clinical trial NCT01904721: A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia
Alopecia, Androgenetic
Baldness
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-07-22
Enrollment: 244
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).


Eligibility criteria: Inclusion Criteria:

* Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
* Willingness to maintain same hair style, length and hair color during study
* Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only)

Exclusion Criteria:

* Drug or alcohol abuse within 12 months
* HIV positive
* Received hair transplants or had scalp reductions
* Use of hair weaves, hair extensions or wigs within 3 months
* Use of minoxidil (oral or topical) and/or low level light treatment "combs" for hair growth within the last 6 months, or expected use during the study
* Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

Primary outcomes:
measure: Change From Baseline in Target Area Hair Count (TAHC)
timeFrame: Baseline, Month 6
measure: Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
timeFrame: Month 6
measure: Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
timeFrame: Month 6
measure: Change From Baseline in Target Area Hair Width (TAHW)
timeFrame: Baseline, Month 6
measure: Change From Baseline in Target Area Hair Darkness (TAHD)
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Fridley
country: United States
state: Minnesota
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: