louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00729404: Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene
Official title: Multicenter, Open-label, Randomized, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations Containing 0.55 mg EE and Either 1.05 or 2.1 mg GSD in Healthy Young Female Vol. Over a Period of 3 Treatment Cycles
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Contraception
Ovulation Inhibition
Keywords: Female Contraception
Ovulation Inhibition
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-08-07
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers

Detailed description: Study was suspended due to inconclusive toxicology findings regarding the used patch formulation to be clarified prior to re-start of the study.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent,
* BMI: 18 - 30 kg/m²,
* Healthy female volunteers,
* Age 18-35 years (smoker not older than 30 years, inclusive),
* Ovulatory pre-treatment cycle, at least 3 month since delivery,
* Abortion or lactation before the first screening examination,
* Willingness to use non-hormonal methods of contraception during entire study

Exclusion Criteria:

* Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/arterial thromboembolic disease
* Regular intake of medication other than OCs
* Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination)
* Anovulatory pre-treatment cycle

Primary outcomes:
measure: The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3.
timeFrame: 4 month
Secondary outcomes:
measure: Assessment of ovarian activity during treatment cycle2 and 3 (Hoogland score)
timeFrame: 4 month
measure: Course of gonadotropins (FSH, LH, P, E2)
timeFrame: 4 month
measure: Endometrial thickness
timeFrame: 4 month
measure: Follicle size
timeFrame: 4 month
measure: Pharmacokinetics of EE, GSD and SHBG in treatment cycles 2 and 3
timeFrame: 4 month
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00572104: Efficacy of Plyometrics to Increase Bone Mass in Men With Osteopenia
Official title: Efficacy of Plyometrics to Increase Bone Mass in Men With Osteopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2007-12-12
Enrollment: 38
Sex: MALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the ability of two types of long term (12 months) weight-bearing exercise treatments (1. high-intensity jumping and 2. weight lifting) to increase bone mass of the total body, spine and hip in physically active men with osteopenia.

Detailed description: The overall goal of this project is to determine the efficacy of chronic (12 months) plyometric jump training exercise on bone mineral density (BMD) and markers of bone turnover in physically active males cyclists diagnosed with osteopenia below normal bone mineral density of the lumbar spine or hip.

Eligibility criteria: Inclusion Criteria:

* Male
* Age 25-60 years
* No symptoms of disease
* Currently participating in cycling activities an average of 4 hr/wk for the previous 24 months
* Osteopenia of the lumbar spine and/or hip (T score \< -1.0 and \> -2.5 )

Exclusion Criteria:

* Medications or supplements that affect bone metabolism or prevent exercise
* Previous or current medical condition affecting bone health
* Osteoporosis of the lumbar spine and/or hip (T score \> -1.0 or \< -2.5)
* Cardiovascular disease
* Metallic implants
* Current smoker
* Current regular participation in high-intensity resistance training and/or plyometrics

Primary outcomes:
measure: Bone Mineral Density
timeFrame: 12 months
Secondary outcomes:
measure: Serum markers of bone turnover
timeFrame: 3 months
measure: Serum hormones regulating bone turnover
timeFrame: 3 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia; McKee Gym
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia, Department of Nutritional Sciences
name: Pamela S Hinton
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02389504: An Investigation of Return to Play Exertion Protocol in Concussed Adolescents
Official title: An Investigation of Return to Play Exertion Protocol in Concussed Adolescents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Concussion
Keywords: Exertion
Efficacy of Treatment
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An Investigation of Return to Play Exertion Protocol in Concussed Adolescents

Detailed description: Written informed parental consent and assent will be obtained for all subjects. The PI or Co-I will administer ImPACT (Immediate Post-Concussion Assessment and Cognitive Testing), the PCSS (Post Concussion Symptom Scale), and the VOMS (Vestibular Ocular Motor Screening) to each subject during their first clinical visit. In addition to demographic variables such as age and gender, groups will be matched based on ImPACT and VOMS performance as well as the number, type, and severity of symptoms reported on the PCSS. Subjects will be assigned to receive either the currently accepted standard of care (Heart Rate Exertion group) or the newly developed exertion protocol (Dynamic Exertion Group). Participants will be matched according to PCSS total, VOMS symptom report, and by demographic variables including age and gender. The first participant will be assigned to the dynamic exertion group and the next to the standard of care group, alternating accordingly as covariates allow. The physical therapists will be responsible for administering the assigned exertion protocol to each subject across four time points (one week between each session). Follow-up data regarding recovery time (i.e., clinical return to normal activity) will also be collected. Neurocognitive testing will take place on 3-4 week intervals as is consistent with clinical practice. The current study will include a pre-exertion neurocognitive evaluation and a post-exertion protocol neurocognitive evaluation.

Eligibility criteria: Inclusion Criteria:

* 14-17 years of age
* Referred to exertion physical therapy within 6 weeks of sport related concussion

Exclusion Criteria:

* Family history of mood or anxiety disorder
* Diagnosis or treatment of migraine
* Diagnosed history of learning disability, ADHD (Attention Deficit Hyperactivity Disorder)
* Concussion history of 3 or more
* Other factors that would prevent subject from completing exertion protocol

Primary outcomes:
measure: Efficacy of the current standard of care exertion protocol versus a newly developed program that emphasizes dynamic movement and sport-specific activities as measured by patient symtom scales and neurocognitive testing performance
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UMPC Sports Medicine Concussion Research Program
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03244904: Next-generation Sequencing of Small Cell Lung Cancer to Identify Susceptibility Gene and to Assess Treatment
Official title: a Prospective Cohort Study for Small Cell Lung Cancer to Identify Susceptibility Gene and Assess DNA Dynamic Change by Next-generation Sequencing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SCLC
Keywords: NGS,SCLC, ctDNA
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2017-08-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SCLC

Brief summary: Participants will be consented into the study after they are found to meet the study inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the participant to give NGS(Next-generation Sequencing).One is according to the germline mutation data to screen susceptible gene in SCLC(Small Cell Lung Cancer); two is to explore the extensive consistency detection of blood and tissues in patients with SCLC gene mutation information; three is to conduct dynamic monitoring of blood ctDNA(circulating tumor DNA) in patients with SCLC during treatment, by changing the types of mutations / abundance (for example: the clonal evolution of typical samples analysis) and change of tumor load, , investigating the patients treatment effect , for the significant change of mutations, to study whether it can be used as molecular marker; four is to analyze of the molecular typing of SCLC, according to the clinical and pathological features of patients.


Eligibility criteria: Inclusion Criteria:

* Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures
* Life expectancy \> 10 months
* Karnofsky Performance Status ≥ 70
* Diagnosis of histological or cytologically confirmed SCLC,
* Age ≥ 18 years
* Good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.

Exclusion Criteria:

* Poor compliance, reluctant to undergo research medication, or follow-up.
* Tumor inaccessible for biopsy
* It is currently included in clinical trials of other drugs, or at the same time, into other medical studies that are considered incompatible with the study.
* It has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years.

Primary outcomes:
measure: susceptibility gene site of small cell lung cancer
timeFrame: 01.11.2017-31.05.2018
Secondary outcomes:
measure: consistency of ctDNA and tDNA sequencing results in patients with SCLC
timeFrame: 01.11.2017-31.05.2018
Other outcomes:
measure: sensitive molecular markers for treating
timeFrame: 01.11.2017-31.05.2018
measure: molecular classification of SCLC
timeFrame: 01.11.2017-31.05.2018
Locations:
Study officials:
affiliation: CSWOG
name: Gen Lin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05699304: Complications After Thyroid Surgeries: 10 Years' Experience
Official title: Complications After Thyroid Surgeries: 10 Years' Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid
Keywords: Thyroidectomy
Hypocalcemia
Stridor
Bleeding
Recurrent Laryngeal Nerve
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 241
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients had thyroid diseases and had thyroidectomy in our hospital in last 10 years.

Brief summary: Thyroidectomy is one of the commonest elective surgeries in surgical practice nowadays. It is associated with wide range of complications, from unnoticed events up to lifelong problems and even life-threatening complications. The most troublesome are bleeding, nerve injury and hypocalcemia. The current study was conducted to report the incidence and predictive factors for perioperative complications, aiming to point out preventive measures.

Detailed description: All files of all patients that had thyroidectomy in the hospital in the last 10 yeas will be reviewed. All demographic and peri-operative data will be collected, tabulated and analyzed.

Incidence and pre-operative predictive factors of every single complication will pointed out and discussed.

Eligibility criteria: Inclusion Criteria:

* All patients had thyroid disease and performed thyroidectomy in the last 10 years in our hospital.

Exclusion Criteria:

* Uncompleted files.

Primary outcomes:
measure: Recurrent Laryngeal nerve injury
timeFrame: 1 week
measure: Bleeding
timeFrame: 2 days
measure: Hypocalcemia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Qena Faculty of Medicine, South Valley University Hospitals
Study officials:
affiliation: South Valley University
name: Abdallah M Taha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ogbera AO, Kuku SF. Epidemiology of thyroid diseases in Africa. Indian J Endocrinol Metab. 2011 Jul;15(Suppl 2):S82-8. doi: 10.4103/2230-8210.83331.
citation: Ernandes-Neto M, Tagliarini JV, Lopez BE, Padovani CR, Marques Mde A, Castilho EC, Mazeto GM. Factors influencing thyroidectomy complications. Braz J Otorhinolaryngol. 2012 Jun;78(3):63-9. doi: 10.1590/S1808-86942012000300012.
citation: Zambudio AR, Rodriguez J, Riquelme J, Soria T, Canteras M, Parrilla P. Prospective study of postoperative complications after total thyroidectomy for multinodular goiters by surgeons with experience in endocrine surgery. Ann Surg. 2004 Jul;240(1):18-25. doi: 10.1097/01.sla.0000129357.58265.3c.
citation: Khanzada TW, Samad A, Memon W, Kumar B. Post thyroidectomy complications: the Hyderabad experience. J Ayub Med Coll Abbottabad. 2010 Jan-Mar;22(1):65-8.
citation: Potenza AS, Araujo Filho VJF, Cernea CR. Injury of the external branch of the superior laryngeal nerve in thyroid surgery. Gland Surg. 2017 Oct;6(5):552-562. doi: 10.21037/gs.2017.06.15.
Clinical trial NCT02298504: Vital Pulp Treatment in Primary Teeth
Official title: Evaluation of MTA Pulpotomy, Biodentine Pulpotomy, and Glass Ionomer Indirect Pulp Treatment in Primary Teeth
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Vital Pulp Therapies
Indirect Pulp Cap
Pulpotomy
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 76
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In primary teeth, decay that is near the pulp (tooth nerve)is treated with either a pulpotomy or indirect pulp treatment if the tooth is not going to be extracted A pulpotomy involves removing the top 1/2 of the pulp, placing a medication/material on the pulp, covering the remaining pulp with a cement, and the restoring the tooth. The purpose of this pilot study is to gain preliminary information regarding the success of Biodentine, MTA, and IPT in the treatment of deep decay in children's primary molars.

Detailed description: Pediatric patients having deep decay in primary molars seen at UMMC, UMSOD, and University of Maryland Rehabilitation and Orthopaedic Institute, will be included in the sample. Teeth with deep caries, \>50% into dentin, will be randomly assigned using a table of random numbers to the three treatment groups:

Group 1 pulpotomy with MTA, Group 2 pulpotomy with Biodentine, Group 3 indirect pulp treatment. Treatment will be performed by board certified pediatric dentists or they will directly supervise pediatric dental residents at each site as part of their regular protocol for treating deep caries.

Radiographs will be taken as prescribed in the Guideline for taking Radiographs in Children by the American Academy of Pediatric Dentistry.

Twice yearly clinical examinations will be performed by the treating dentists or pediatric dental residents to check for any soft tissue pathology such as abscess or mobility of treated tooth/teeth. If treatment success/failure consensus between the blinded dentists is not reached, a third dentist will be consulted.

The success/failure data will be entered onto spreadsheets and examined statistically using statistical software.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients with deep dental decay in primary molars
* Teeth with signs and symptoms of reversible pulpitis

Exclusion Criteria:

* Teeth with clinical symptoms of irriversible pulpitis or pulp necrosis or acute dental infection
* Children with systemic illness that contraindicated vital pulp treatment such a sickle cell disease
* Teeth that are not restorable

Primary outcomes:
measure: Clinical success after pulpotomy
timeFrame: 3 years
measure: Clinical success after indirect pulp cap
timeFrame: 3 years
measure: Radiographic success after pulpotomy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Dentistry
state: Maryland
Study officials:
References:
Clinical trial NCT02869204: The Effect of a Local Injection of a Platelet Concentrate on Infection and Healing of Surgical Wounds
Official title: The Effect of L-PRP on Wound Healing and Wound Infection After Pancreaticoduodenectomy / Whipples Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Infection and Wound Healing
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2016-08-16
Enrollment: 40
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 purpose of this project is to investigate whether a combination of a local injection of platelet rich plasma (PRP) combined with a daily supplement of vitamin C, zinc, L-arginine, as well as high protein diet (1.5 g of protein per kilo body weight per day) can promote tissue healing in patients undergoing open upper-abdominal surgery.

Primary endpoint is cases of wound infection and secondary endpoints are time of tissue regeneration (days), judged by traditional clinical observation and experimentally assessed by ultrasound.

The experiment is performed as a parallel two-armed, randomized, controlled trial.

A total of 40 subjects will be included in the trial i order to ensure the power of the study, despite a drop off of up to 25%.


Eligibility criteria: Inclusion Criteria:

* Patient at Rigshospitalets Surgical gastroenterology clinic
* Planned to have a Pancreaticoduodenectomy preformed
* Being able to understand Danish, the trial and what it means to be enrolled in the trial
* Capable of signing a written consent
* Living i the Regional Capital (excl. Bornholm) or the Regional of Sjælland (north of Næstved)

Exclusion Criteria:

* Dysregulated diabetes mellitus type I or II
* Alcohol consumption above 14 or 7 x 12 g alcohol per week (men vs women)
* Participating in another clinical trial

Primary outcomes:
measure: Number of patients with wound infection assessed by traditional clinical observation of the cicatrice
timeFrame: From date of surgery until the date of first documented event of infection or date of death from any cause, whichever came first, assessed up to 30 days .
Secondary outcomes:
measure: Number of days before the surgical wound are full epithelized assessed by observation of the cicatrice
timeFrame: Up to 30 days
measure: Other postoperative complications
timeFrame: Up to 30 days
measure: Length of stay (LOS)
timeFrame: 30 days
measure: Experience of pain assessed by a VAS (Visual analogue scale)
timeFrame: Up to 30 days
measure: Mobilization assessed by "Timed Up & Go (TUG)"
timeFrame: Up to 30 days
measure: Inflammatory responds assessed by blood sample analysis of the acute phase reactant CRP (c-reactive protein)
timeFrame: Up to 30 days
measure: Inflammatory responds assessed by blood sample analysis of the acute phase reactant leucucytes
timeFrame: Up to 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00915304: Evidence-Based Medicine Electronic Decision Support Study
Official title: Patient Specific Automatic Reminders in Primary Care - the EBMeDS Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Decision Support Systems, Clinical
Keywords: Clinical Decision Support System
Automatic reminder
Primary care
Evidence-Based Medicine
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: The Finnish Medical Society Duodecim
name: Finnish Institute for Health and Welfare
name: Duodecim Medical Publications Ltd.
name: ProWellness Ltd.
name: The Finnish Funding Agency for Technology and Innovation (TEKES)
First posted: 2009-06-08
Enrollment: 12101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to analyze the effect of the Evidence-Based Medicine electronic Decision Support (EBMeDS) automatic reminders in primary health care.

Hypothesis (1)is that in the intervention group the total number of EBMeDS reminders will decrease compared to the control group.

Hypothesis (2) is that in the intervention group the quality measures will increase faster compared to the control group at follow-up time.


Eligibility criteria: Inclusion Criteria:

* All residents of Sipoo who have patient ID number in the Mediatri electronic patient record system in Sipoo Health Centre

Exclusion Criteria:

* Those residents who's occupational health care is produced by Sipoo Health Centre

Primary outcomes:
measure: The number of reminders triggered (in relation to the number of eligible patients, Ri/Ni) during repeated Virtual Health Checks (VHCs)
timeFrame: Follow-up time max one and half year
Secondary outcomes:
measure: Specific clinical measures compared to an intervention and a control group
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: University of Tampere; School of Health Sciences
Study officials:
affiliation: University of Tampere; School of Health Sciences
name: Pekka Rissanen, Professor
role: STUDY_DIRECTOR
affiliation: University of Tampere; School of Health Sciences
name: Tiina Kortteisto, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kortteisto T, Raitanen J, Komulainen J, Kunnamo I, Makela M, Rissanen P, Kaila M; EBMeDS (Evidence-Based Medicine electronic Decision Support) Study Group. Patient-specific computer-based decision support in primary healthcare--a randomized trial. Implement Sci. 2014 Jan 20;9:15. doi: 10.1186/1748-5908-9-15.