louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04389489: Postpartum Sexual Function in Pregnant Women With COVID-19
Official title: Evaluation of Pregnant Women Diagnosed With COVID-19 Using Carol Postpartum Sexual Function and Dyspareunia Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Dyspareunia
Postpartum Period
Keywords: Postpartum Period
Dyspareunia
COVID-19
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the reproductive age between 18-45 years old, two groups of 70 people will be selected, consisting of puerperant diagnosed with COVID-19 and healthy puerperant. Patients who have cesarean or vaginal delivery at the end of the study group, who do not have sexual intercourse dysfunction for another reason (such as Stage 3-4 perineal injury, vaginismus) will be selected.

Brief summary: The aim of this study is to identify women with postpartum sexual dysfunction and dyspareunia risk in the early period and to use the treatment and care services they need effectively. Our secondary aim is to reveal the difference in sexual life in the postpartum period between healthy pregnant women and pregnant women diagnosed with COVID-19.


Eligibility criteria: Inclusion Criteria:

* Pregnant Patient with COVID-19

Exclusion Criteria:

* Those with known sexual dysfunction disorder

Primary outcomes:
measure: Evaluation of pregnant women diagnosed with COVID-19 using Carol Postpartum Sexual Function and Dyspareunia Scale
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of pregnant women diagnosed with COVID-19 using Carol Postpartum Sexual Function and Dyspareunia Scale
timeFrame: 3 Months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Halkali
Study officials:
References:
citation: Lopez-Lapeyrere C, Serna-Gomez N, Hernandez-Lopez AB, Perez-Garcia MF, Tejeda-Esteban A, Solis-Munoz M. The development and validation of a new postpartum sexual function and dyspareunia assessment tool: The Carol Scale. Midwifery. 2018 Mar;58:27-36. doi: 10.1016/j.midw.2017.11.008. Epub 2017 Dec 6.
Clinical trial NCT03560089: Serious Games Rehabilitation Programme to Treat Gait and Balance Disorders in PD Patients
Official title: Serious Games Rehabilitation Programme to Treat Gant and Balance Disorders in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Gait
Rehabilitation
Serious game
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2018-06-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the effects of a serious game rehabilitation programme in 50 patients with Parkinson's disease with gait and balance disorders in a randomised controlled study


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease
* Gait and balance disorders resistant to dopaminergic medication

Exclusion Criteria:

* dementia
* contra-indication to magnetic resonance imaging

Primary outcomes:
measure: Duration of the time-up-go test
timeFrame: change between baseline and at 6 weeks
Secondary outcomes:
measure: Duration of the time-up-go test
timeFrame: change between baseline and at 18 weeks
measure: Step length
timeFrame: change between baseline and at 6 weeks
measure: step velocity
timeFrame: change between baseline and at 6 weeks
measure: Movement disorders Unified Parkinson's disease rating scale
timeFrame: change between baseline and at 6 weeks
measure: freezing of gait questionnaire
timeFrame: change between baseline and at 6 weeks
measure: Parkinson's disease quality of life scale
timeFrame: change between baseline and at 6 weeks
measure: gait and balance scale
timeFrame: change between baseline and at 6 weeks
measure: Montreal Cognitive Assessment
timeFrame: change between baseline and at 6 weeks
measure: Magnetic resonance imaging
timeFrame: change between baseline and at 6 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Investigation Clinique- ICM
Study officials:
affiliation: ICM, 47 bd de l'Hôpital, 75013 Paris
name: Marie Laure Welter, PH MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00254189: Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
Official title: A Single Center, Open-Label Study to Evaluate the Effects on Ovulation of Levonorgestrel 90mg and Ethinyl Estradiol 20mg in a Daily, Continuous, Oral Regimen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovulation
Keywords: Ovulation
Oral Contraceptive
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 0
Maximum age (years): 36
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the ability of a monophasic oral contraceptives ("OC") regimen of Levonorgestrel ("LNG") 90 mg and Ethinyl Estradiol ("EE") 20 mg to inhibit ovulation during 84 days of continuous therapy.


Eligibility criteria: Inclusion Criteria:

* Healthy women of legal age of consent who are willing to use a combination OC.
* Subjects must be under the age of 36 at the time of enrollment (visit 3).
* Subjects must have had regular (24 to 32 day) menstrual cycles for the 3-month period preceding entry into the pretreatment observation cycle, excluding postabortal and nonnursing postpartum subjects. Postabortal and nonnursing postpartum subjects must have completed at least 1 regular (24 to 32 day) spontaneous menstrual cycle before entry into the pretreatment observation cycle. The pretreatment observation cycle for all subjects will begin on day 1 of the subsequent spontaneous menses.

Other inclusions apply.

Exclusion Criteria:

A history or the presence of any of the following will prevent enrollment:

* Thrombophlebitis, thrombosis, or thromboembolic disorders.
* Deep vein thrombosis.
* Pulmonary embolism.

Other exclusions apply.

Primary outcomes:
measure: To determine the ability of a monophasic oral contraceptive (OC) regimen of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg to inhibit ovulation during 84 days of continuous therapy.
Secondary outcomes:
measure: To assess the safety profile. To assess the ovarian activity, as measured by the Hoogland and Skouby 6-point grading system, during 84 days of continuous therapy. To evaluate the time to return of ovulation after cessation of treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Archer DF, Kovalevsky G, Ballagh SA, Grubb GS. Ovarian activity and safety of a novel levonorgestrel/ethinyl estradiol continuous oral contraceptive regimen. Contraception. 2009 Sep;80(3):245-53. doi: 10.1016/j.contraception.2009.03.006. Epub 2009 May 2.
Clinical trial NCT02215889: Partial Liver Segment 2/3 Transplantation Study
Official title: A Phase I/II Clinical Trial to Evaluate the Benefit and Efficacy of Liver Resection And Partial Liver Segment 2/3 Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Liver Metastases From ColoRectal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Keywords: Liver metastases
Transplantation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 20
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: The patients will receive hepatectomy as a 2 stage procedure. In the first surgical procedure liver segments 2-3 are removed and liver donor segments 2-3 inserted. After growth of donor segments 2-3, the remaining liver segments of the recipient are removed. The patient will at this time have only donor liver tissue in place.


Eligibility criteria: Inclusion Criteria:

* Histologically verified adenocarcinoma in colon/rectum.
* Liver metastases, not amenable to liver resection
* No signs of extra hepatic metastatic disease or local recurrence according to PET/CT scan within 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all\<15mm.
* No signs of extra hepatic metastatic disease on CT thorax/abdomen/pelvis within 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all\<15mm.
* No local recurrence according to MR-pelvis scan in patients with rectal cancer within 4 weeks prior to the faculty meeting at the transplant unit
* No signs of local recurrence judged by colonoscopy / CT colography within 12 months prior to the faculty meeting at the transplant unit
* Good performance status, ECOG 0 or 1.
* Satisfactory blood tests: Hb \>10g/dl, neutrophiles \>1.0 (after any G-CSF), TRC \>75, Bilirubin\<2 x upper normal level, ASAT,ALAT\<5 x upper normal level, Creatinine \<1.25 x upper normal level. Albumin above lower normal level.
* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national/local regulations.
* All patients should have received at least 8 weeks of chemotherapy.

Exclusion Criteria:

* Weight loss \>10% the last 6 months
* Patient BMI \> 30
* Previous diagnosed bone or CNS metastatic disease.
* Previous diagnosed cancer mammae or malignant melanoma.
* Palliative resection of primary CRC tumor.

Primary outcomes:
measure: Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation.
timeFrame: 4 weeks
Secondary outcomes:
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT02644889: EGFR Mutation Detection From Advanced NSCLC Patient Tissue and Plasma in EGFR-TKI Treatment
Official title: Epidermal Growth Factor Receptor (EGFR) Mutation Detection From Advanced Non-small Cell Lung Cancer Tissue and Plasma in Tyrosine Kinase Inhibitor (TKI) Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Keywords: Epidermal growth factor receptor(EGFR)
NSCLC
Lead sponsor: GenoSaber
Sponsor class: INDUSTRY
First posted: 2016-01-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage Ⅲ-Ⅳ NSCLC with EGFR mutations and who began a treatment by TKI .

Brief summary: This study has been designed in order to detect EGFR mutation abundance of tissue and concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and prognosis.


Eligibility criteria: Inclusion Criteria:

* Age older than 18 years and under 75 years
* Histologically and cytologically proven non-small Cell Lung Cancer
* Clinical stages Ⅲ \~ Ⅳ
* Not receive any anti-tumor treatment
* Eastern cooperative oncology group performance status (ECOG PS) =1\~2
* Estimated survival time more than 3 months
* EGFR-TKI treatment for first-line or second-line
* Voluntary to participate in this clinical trial and sign the consent form

Exclusion Criteria:

* Patients have received EGFR-TKI therapy before the study
* With other malignancy history in the recent 5 years before the study
* Pregnancy or breast feeding phase
* Inadequate samples for testing
* Follow-up compliance is poor

Primary outcomes:
measure: EGFR Mutation Detection of FFPE and plasma samples
timeFrame: baseline
measure: EGFR Mutation Detection of plasma samples for the following-up patients who take TKI.
timeFrame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01285089: Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia
Official title: Prospective French Study on ACQUIred Haemophilia Treatment With Recombinant Factor VIIa (NovoSeven®) A Prospective Observational Study on the Use of NovoSeven® (Activated Recombinant Human Factor VIIa) for the Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Bleeding Disorder
Acquired Haemophilia
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-01-27
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient diagnosed with acquired haemophilia and treated with at least one injection of activated recombinant human factor VII can be included in the study. The treatment will be performed according the local practice.

Brief summary: This study is conducted in Europe. The aim of this prospective, observational study are to describe the different clinical practice and detailed haemostatic management of activated recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France. The secondary aim is to assess the primary haemostasis disorder associated with the coagulation disorders, if available.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with acquired haemophilia
* Treated with activated recombinant human factor VII as first line treatment
* Treated with activated recombinant human factor VII after January 2011

Exclusion Criteria:

* Patients with first diagnosis before january 2010 and having a relapse after january 2011
* Known hypersensitivity to NovoSeven®, or to mouse, hamster or bovine protein

Primary outcomes:
measure: Identification of decision criteria to treat patient with activated recombinant human factor VII
timeFrame: Year 3
Secondary outcomes:
measure: Number of patients with a control of bleeding
timeFrame: Year 3
Other outcomes:
Locations:
city: Paris La défense cedex
country: France
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01274689: External Lid Loading for the Temporary Treatment of the Paresis of the M. Orbicularis Oculi: a Clinical Note
Official title: External Lid Loading for the Temporary Treatment of the Paresis of the M. Orbicularis Oculi: a Clinical Note
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incomplete Closure of Lid
Parotis Tumor
m. Orbicularis Oculi Paresis
Keywords: lagophthalmos
parotis tumor
m. orbicularis oculi paresis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Medical Park AG
First posted: 2011-01-11
Enrollment: 152
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with lagophthalmos due to surgery, central or peripheral paresis

Brief summary: The note re-introduces the external lid loading with the help of a lead weight for the temporary treatment of lagophthalmos. Although simple and effective, the technique is rarely used.Instead of wearing a monoculus, the patient uses an individually tailored lead weight (0.8 mm thickness, 1.0 -2.0 g) sticked on the lid, it enables its closure. A spontaneous ptosis indicates a too heavy weight. With the M. levator palpebrae intact, lid lifting is possible. The effect is gravity dependent, so that the patient has to wear the monoculus at night. To minimize the risk of lead intoxication, the surface of the weight is varnished. In case of a persistent paresis of the M. orbicularis oculi an internal lid loading can follow. A total of 152 lagophthalmos cases have been treated since 1997.All patients could close the lid immediately. Almost half of the patients had to re-adjust the weight several times per day due to hooded eyelids. The compliance was high, and a partial or complete restoration of the function of the M. orbicularis oculi occurred in 60% of the cases. In some subjects, the restoration of the M. orbicularis oculi was faster than of the M. orbicularis orbis. The external lid loading for the temporary treatment of lagophthalmos is simple and effective. Compared to a monoculus, the vision is unimpaired and the aesthetic is more appropriate for most patients. The faster restoration of the M. orbicularis oculi hints at a potentially facilitatory effect of the weight.


Eligibility criteria: Inclusion Criteria:

* lagophthalmos due to surgery, central or peripheral paresis able to understand the purpose of the study

Exclusion Criteria:

* skin irritations and/or open wounds in the area of the applied lead weight

Primary outcomes:
measure: responder lid closure
Secondary outcomes:
measure: skin irritation
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medicine Berlin, Medical Park Berlin
Study officials:
affiliation: Charite - University Medicine Berlin, Medical Park Berlin
name: Stefan Hesse, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller-Jensen K, Muller-Jensen G. [Surgical and conservative treatment of lagophthalmus (facial paralysis). II]. Ophthalmologe. 1993 Feb;90(1):27-30. German.
Clinical trial NCT02145689: Long-Term Study of OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Muscle Spasticity
Stroke
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.


Eligibility criteria: Inclusion Criteria:

* For patients entering from the 191622-127 study, successful completion of study 191622-127
* For patients entering directly into study 191622-129, upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago

Exclusion Criteria:

* Spasticity in the non-study upper limb that requires treatment
* Presence of fixed contractures in of the study muscles in elbow or shoulder
* Profound atrophy of muscles to be injected
* Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months
* Injection of corticosteroids or anesthetics, use of casting or dynamic splinting or constraint-induced movement therapy (CIMT) for the study limb within 3 months
* Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month
* Condition other than stroke contributing to upper limb spasticity
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis

Primary outcomes:
measure: Change from Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Treated Muscle Groups Using a 6-Point Scale
timeFrame: Baseline, Up to 60 Weeks
Secondary outcomes:
measure: Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale
timeFrame: Baseline, Up to 60 Weeks
measure: Change from Baseline in Pain on an 11-Point Scale
timeFrame: Baseline, Up to 60 Weeks
measure: Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score
timeFrame: Baseline, Up to 60 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03032289: Association Between Active Transport and Acute Myocardial Infarction
Official title: Association Between Active Transport and Acute Myocardial Infarction: Cross Sectional Ecological Study Using National Registry and Census Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: active transport
cycling
walking
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 100482
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases of acute myocardial infarction recorded in the Myocardial Ischaemia National Audit Project (MINAP).

Brief summary: This study aims to investigate the association between active transport and the incidence of acute myocardial infarction in England.

Detailed description: This is a cross sectional ecological study using aggregated data from the existing Myocardial Ischaemia National Audit Project between 2010 and 2013. Data on active transport according to local authority was obtained from the UK 2001 and 2011 census, whilst important confounders including deprivation levels, prevalence of obesity and population smoking estimates were obtained from Public Health England.

In addition to investigating the association between active transport and AMI, we also studied the extent to which the components of active transport, cycling and walking, were associated with AMI, and investigated whether any associations were contingent on a time lag effect between the dates of exposure to active transport and indecent AMI.

Eligibility criteria: Inclusion Criteria:

* All cases of acute myocardial infarction recorded in MINAP between 2003 and 2010

Exclusion Criteria:

* Cases aged \<16 and \>64 years

Primary outcomes:
measure: Acute myocardial infarction
timeFrame: 2010 to 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Institute for Data Analytics
Study officials:
References: