louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05103982: Testing a New Self-help Intervention for Infertility Related Distress: a Pilot Study
Official title: Testing a New Self-help Intervention for Infertility Related Distress: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Infertility, Female
Keywords: infertility-related distress
depression
anxiety
Lead sponsor: University of Regina
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study will test the effect of a 6-week self-help program in improving fertility-related quality of life as well as anxious and depressive symptoms, in women with infertility.

Detailed description: Twenty women with infertility living in Saskatchewan will be recruited and will be emailed six weekly 10-minute videos, each providing instructions on a new psychological technique that is aimed at addressing the emotional and interpersonal challenges of infertility. Fertility-related quality of life, depressive symptoms, and anxious symptoms will be measured before and after the program. Outcomes will also be measured weekly for three weeks post-intervention. Feedback about how to improve the program will also be collected.

Eligibility criteria: Inclusion Criteria:

* Has been trying to get pregnant for 12+ months and has failed OR is currently undergoing fertility treatments due to a diagnosis of infertility
* Lives in Saskatchewan, Canada
* Reports a high level of distress related to infertility, as indicated by a FertiQoL score below 52 or at least mild anxious or depressive symptoms (GAD-7 score of 5 or above or PHQ-9 score of 5 or above)

Exclusion Criteria:

* Has a history of suicide attempts
* Is currently experiencing suicidal ideation
* Reports severe depressive symptoms, as indicated by a PHQ-9 score above 19
* Reports severe anxious symptoms, as indicated by a GAD-7 score above 14

Primary outcomes:
measure: Fertility Quality of Life tool (Fertiqol)
timeFrame: Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)
Secondary outcomes:
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)
Other outcomes:
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
Study officials:
References:
Clinical trial NCT02760082: Motivation of Patients Diagnosed With Multiple Sclerosis to Become Citizen Researchers
Official title: Identifying Motivational Factors for Registering Nutrition and Lifestyle Factors Among Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Qualitative study
Motivation
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Danish Multiple Sclerosis Society
First posted: 2016-05-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Multiple Sclerosis

Brief summary: The study will based on qualitative methods investigate motivational factors among patients diagnosed with multiple sclerosis for registering nutrition, environmental factors, stress provoking factors and physical activity (NESPA). The aim is to gain knowledge on motivational factors for using a digital tool for collecting data on NESPA and incorporate this knowledge into a form which can be used in requirement specifications for such a digital tool.


Eligibility criteria: Inclusion Criteria:

* Age 18 or above
* Read, write and understand Danish

Exclusion Criteria:

* Aphasia
* Severe cognitive impairment

Primary outcomes:
measure: Analysis of qualitative interviews and measurement of eHealth literacy (eHealth literacy questionnaire)
timeFrame: Up to 6 months
measure: Evaluation of motivational factors based on questionnaire survey
timeFrame: Up to 10 months
measure: Analysis of focus group interviews on motivational factors for registering nutrition and lifestyle factors among patients with multiple sclerosis
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
References:
Clinical trial NCT04418882: Septic Management and Outcome of Open Fracture
Official title: Septic Management and Outcome of Open Fracture : a 7 Years Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Fracture
Pseudarthrosis
Bone and Joint Infection
Keywords: bone and joint infection
Pseudarthrosis
Open Fracture
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having had an open fractures managed at the HCL

Brief summary: The aim is the study of the management and outcome of the open fractures.

Some open fractures will become pseudarthrosis. Thoses pseudarthrosis may be septic or not.

The management and evolution of all the open fractures will be described in order to identify the presence or not of a sepsis and then a development of a pseudarthrosis (septic or non septic).


Eligibility criteria: Inclusion Criteria:

* all patients with open fractures

Exclusion Criteria:

-

Primary outcomes:
measure: description of non septic open fracture
timeFrame: 24 months
measure: description of patients with non septic open fracture
timeFrame: 1 month
measure: description of septic open fracture : bacteriology
timeFrame: 24 months
measure: description of septic open fracture : evolution
timeFrame: 24 months
measure: description of septic open fracture : management
timeFrame: 24 months
measure: description of septic open fracture : patients
timeFrame: 24 months
measure: description of pseudarthrosis: symptoms
timeFrame: 24 months
measure: description of pseudarthrosis : management
timeFrame: 24 months
measure: description of septic pseudarthrosis : patients
timeFrame: 24 months
measure: description of septic pseudarthrosis : bacteriology
timeFrame: 24 months
measure: treatment failure
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT03322982: Low Fat Diet for Fatigue in MS
Official title: A Randomized, Controlled Trial of Low-fat Diet for Fatigue in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: diet, low-fat
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2017-10-26
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A randomized, controlled pilot trial of a dietary intervention vs. wait-list control in patients with MS and fatigue for management of their fatigue. The hypothesis of this study is that participants following the low-fat study diet will demonstrate a significant reduction in fatigue after four months compared to wait list controls.


Eligibility criteria: For participants with MS:

Inclusion Criteria:

* Age 18-70
* Diagnosis of MS by 2010 McDonald Criteria
* EDSS ≤ 7.5
* Experiencing moderate to severe fatigue (MFIS ≥ 38)

Exclusion Criteria:

* Current cardiopulmonary disease requiring treatment
* Diabetes
* Pregnancy or breast-feeding
* MS exacerbation within 30 days of screening visit
* IV steroids within 30 days of screening visit
* Dietary fat content of \<30% as assessed by food frequency questionnaire (FFQ) at screening visit
* Fish oil or flax seed oil supplementation within 30 days of screening visit

Primary outcomes:
measure: Fatigue
timeFrame: Baseline to month 4
Secondary outcomes:
measure: Fatigue
timeFrame: Baseline to month 4
measure: Disability
timeFrame: Baseline to month 4
Other outcomes:
measure: Microbiome- Relative abundance of targeted species of gut microflora
timeFrame: Baseline to month 4
Locations:
city: Portland
country: United States
facility: Oregon Health Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Vijayshree Yadav
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03130582: High-dose Etoposide Could Discriminate Patients With Refractory/Relapsed Lymphoma Benefit From APBSCT
Official title: 2008 WHO Myeloid and Lymphocytic Tumor Diagnostic Criteria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: high-dose etoposide,autologous peripheral blood stem cell transplantation
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 88
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with refractory/relapsed lymphoma

Brief summary: patients with refractory /relapsed lymphoma received high-dose etoposide for hematopoietic stem cell (HSC) mobilization.All patients received high-dose etoposide 20-25 mg/kg/d intravenously for two consecutive days followed by rhG-CSF10ug/kg/day subcutaneously at 48 hours after chemotherapy; rhG-CSF was continued until the end of harvesting for HSCs/HPCs. Peripheral blood counts were performed daily for all patients following the initiating of rhG-CSF. Leukapheresis was performed when peripheral blood white blood count exceeded 4×109/L with blood cell The harvested cells reached at least 2\*108/kg for mononuclear cells and/or 2\*106/kg for CD34+ cells with once to twice leukapheresis. The final product was kept frozen in liquid nitrogen.Auto-PBSCT


Eligibility criteria: Inclusion Criteria:

* relapsed/refractory lymphoma ,siut APBSCT

Exclusion Criteria:

* bone marrow without involvement by lymphoma cells

Primary outcomes:
measure: death
timeFrame: 10 years
measure: CR
timeFrame: 10 years
measure: relapse
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01240382: Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
Official title: Double-masked Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Multi-center Study, in Comparison to 0.1% Sodium Hyaluronate Ophthalmic Solution) - Phase III Confirmatory Study -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-11-15
Enrollment: 332
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT

Brief summary: To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.


Eligibility criteria: Inclusion Criteria:

* Those who show:

  * Keratoconjunctival disorder confirmed with vital dye staining
  * Abnormal Schirmer score results

Exclusion Criteria:

* Eye disease that needs therapy other than that for dry eye
* Those who need to wear contact lenses during the clinical study

Primary outcomes:
measure: Mean Change in Fluorescein Staining Score From Baseline
timeFrame: Baseline and 4-week (discontinued (LOCF))
measure: Mean Change in Rose Bengal Staining Score From Baseline
timeFrame: Baseline and 4-week (discontinued (LOCF))
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Santen study sites
Study officials:
References:
citation: Takamura E, Tsubota K, Watanabe H, Ohashi Y; Diquafosol Ophthalmic Solution Phase 3 Study Group. A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients. Br J Ophthalmol. 2012 Oct;96(10):1310-5. doi: 10.1136/bjophthalmol-2011-301448. Epub 2012 Aug 21.
Clinical trial NCT03818282: Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) for First-line Chemotherapy of Ovarian Cancer
Official title: Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) in Combination With Carboplatin for First-line Chemotherapy of Ovarian Cancer: A Multicenter, Open-label, Single-arm Phase 2 Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Preliminary evaluation of the efficacy and safety of paclitaxel for injection (albumin-bound) in combination with carboplatin for first-line chemotherapy of ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* Age: 18 to 75 years;
* Histologically confirmed epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer;
* Patients with stage IC-IV according to the International Federation of Obstetrics and Gynecology (FIGO) and who underwent an ideal tumor reduction procedure within 6 weeks prior to enrollment;
* Lesion is measurable according to RECIST 1.1 criteria or patient's CA125 is evaluable according to GCIG criteria;
* ECOG performance status of 0-2;
* Expected survival ≥ 3 months;
* Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L;
* Hepatic and renal function: Serum creatinine ≤ 1.5×ULN; AST and ALT ≤ 1.5×ULN or ≤ 5×ULN in the presence of hepatic metastasis; Total bilirubin ≤ 1.5×ULN, or ≤ 2.5×ULN in patients with Gilbert's syndrome;
* Must agree to use effective contraception during the trial; Women of childbearing potential must have a negative serum or urine pregnancy test; Non-lactating patients.

Exclusion Criteria:

* Ovarian low-grade malignant tumor patients;
* Patients who have received abdominal or pelvic radiotherapy;
* Patients with central nervous system disease or brain metastases;
* Other malignancies have occurred within the last 5 years, except for cervical carcinoma in situ, non-melanoma skin cancers that have been cured;
* Prior Grade ≥ 2 sensory or motor neuropathy;
* Uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
* Known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients;
* Receive other study drug chemotherapy within 30 days of the first dose of chemotherapy;
* Patients not suitable for participation in this study judged by investigator.

Primary outcomes:
measure: Progression free Survival
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04108182: A Registry Study of Biomarkers in Progression of Acute Heart Failure(BIOMS-POAHF)
Official title: A Registry Study of Biomarkers in Progression of Acute Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Keywords: heart failure
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure accorrding to Inclusion and exclusion criteria

Brief summary: The registry study aims to discover the prognostic value of bio-markers in acute heart failure


Eligibility criteria: Inclusion Criteria:

* 1. Patients aged greater than or equal to 18 years with acute exacerbation of chronic heart failure or new heart failure
* 2. With typical symptoms of acute heart failure as follows: Dyspnea, ankle swelling and fatigue (Limited activity endurance), increased jugular pressure, rales and peripheral edema ;
* 3. Plasma concentrations of BNP: BNP\>100pg/ML
* 4. Echocardiography: Related structural heart disease (left ventricular hypertrophy and/or left atrial enlargement) and/or diastolic dysfunction

Exclusion Criteria:

* 1. Previous history of cancer or renal replacement therapy
* 2.Surgery was performed within a month
* 3.Accompanied by cardiogenic shock, sepsis, pneumonia
* 4.Eligible patients without informed consent form

Primary outcomes:
measure: Number of death ( all cause) or readmission for heart failure
timeFrame: a median follow-up of 8.8 months
Secondary outcomes:
measure: Number of death ( all cause) or readmission for heart failure and cardiovascular mortality
timeFrame: a median follow-up of 8.8 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
Study officials:
affiliation: Beijing Anzhen Hospital
name: Jie Du, PHD
role: STUDY_DIRECTOR
References:
citation: Ma K, Yang J, Shao Y, Li P, Guo H, Wu J, Zhu Y, Zhang H, Zhang X, Du J, Li Y. Therapeutic and Prognostic Significance of Arachidonic Acid in Heart Failure. Circ Res. 2022 Apr;130(7):1056-1071. doi: 10.1161/CIRCRESAHA.121.320548. Epub 2022 Mar 8.
Clinical trial NCT04214782: Detection of Ovarian Cancer Using an Artificial Intelligence Enabled Transvaginal Ultrasound Imaging Algorithm
Official title: Detection of Ovarian Cancer Using an Artificial Intelligence Enabled Transvaginal Ultrasound Imaging Algorithm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Hubei Cancer Hospital
name: Qilu Hospital of Shandong University
name: Henan Cancer Hospital
name: Xiangyang Central Hospital
name: The First People's Hospital of Jingzhou
name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2020-01-02
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Ovarian cancer is relatively rare but fatal with an annual incidence rate of 11.8 per 100 000 and a high mortality-to-incidence ratio of \>0.6. The modest diagnostic accuracy of TVU has risen some concerns about the over-treatment.Now, with the development of artificial intelligence (AI), we may have a better chance to interpret TVU imagines with high efficiency, reproducibility and accuracy.


Eligibility criteria: Inclusion Criteria:

* Women scheduled for Transvaginal Ultrasound examination for adnexal lesions;
* Women aged over 18 years old;
* Women willing to participant in this study evidenced by signing the informed consent.

Exclusion Criteria:

* Women without adnexa for any reasons at the time of Transvaginal Ultrasound examination, including but not limited to receiving surgical removal for adnexa;
* Women with a pathologic diagnosis of ovarian cancer before the Transvaginal Ultrasound examination;
* Women with mental abnormal;
* Women did not cooperate or participate in other clinical trials;
* Pregnant or lactating women.

Primary outcomes:
measure: diagnostic accuracy
timeFrame: 2 years
Secondary outcomes:
measure: time cost for Transvaginal Ultrasound image interpretation
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Hospital
name: Qinglei Gao, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02433782: Myofascial Therapy in Patients With Hemophilic Arthropathy
Official title: Physiotherapy Protocol by Myofascial Therapy and Randomized Clinical Study in Patients With Hemophilic Arthropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemophilia
Keywords: Haemophilia
Arthropathy
Pain
Range of motion
Miofascial techniques
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Designing a treatment protocol using myofascial therapy for the treatment of pain and restrictions on mobility in patients with hemophilic arthropathy of the knee and ankle.

Pilot with a small number of patients for assessment the effectiveness and safety of the treatment protocol created.

Randomized clinical trial to assess the effectiveness of treatment with myofascial therapy in patients with hemophilia.

Describe the differences in terms of the dependent variables (range of motion, pain and flexibility) in patients with hemophilia who have carried out the treatment.

Report the relationship between the clinical characteristics of patients and the results obtained after the treatment period.

Detailed description: Phase I pilot study with 5 patients with hemophilia for assessment by myofascial therapy protocol designed for this purpose.

Phase II. Randomized, prospective longitudinal clinical study in patients with hemophilia, to assess the efficacy of an intervention with myofascial therapy.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of hemophilia A and B.
* Patients older than 18 years.
* Patients with a diagnosis of hemophilic arthropathy of the knee and ankle.
* Patients on prophylactic regimen with FVIII / FIX.

Exclusion Criteria:

* Patients without walking ability.
* Patients with a diagnosis of other congenital coagulopathy (eg von Willebrand disease).
* Patients who have developed antibodies to FVIII / FIX (inhibitors).
* Patients with neurological or cognitive impairments that impede understanding of questionnaires and physical test.
* Patients who have not signed the informed consent document.

Primary outcomes:
measure: Bleeding frequency
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes:
measure: Pain
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
measure: Joint function
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
measure: Range of motion
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio, Murcia
Study officials:
affiliation: Universidad Católica San Antonio
name: JAVIER MEROÑO-GALLUT, PhD
role: STUDY_CHAIR
References: