louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01718574: Bibliotherapy for Patients With Cancer
Official title: Feasibility, Acceptability and Efficacy of Bibliotherapy for Patients With Cancer: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: self-help book
support service
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Cedars CanSupport, Hope & Cope
First posted: 2012-10-31
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the efficacy of a self-help workbook in enhancing a sense of empowerment, coping, quality of life and reducing distress for patients with cancer.


Eligibility criteria: Inclusion Criteria:

* 18+ years of age
* been diagnosed with cancer
* can read English

Exclusion Criteria:

-participating in the "Think Smart, Live Well" group

Primary outcomes:
measure: change in Health Education Impact Questionnaire scores
timeFrame: pre-intervention (week 0), post intervention (week 6), follow-up (week 10)
Secondary outcomes:
measure: change in Ways of Coping Questionnaire - Cancer Version & Hospital Anxiety and Depression Scale scores
timeFrame: pre-intervention (week 0), post intervention (week 6), follow-up (week 10)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: MUHC Cedars CanSupport
state: Quebec
city: Montreal
country: Canada
facility: Hope & Cope, JGH
state: Quebec
Study officials:
References:
Clinical trial NCT02372474: "It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure
Official title: "It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Premature Ovarian Failure
Keywords: POF
ESS
stem cell therapy
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 112
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) therapy in women suffering from POF.

Detailed description: Stem cells (sc) are the foundation cells for every organ, tissue and cell in the body. They are self sustaining and can replicate themselves for long periods of time. They have the remarkable potential to develop in many different cell types in the body. Premature ovarian failure (POF) is the loss of ovarian function in women less than 40 years. It is associated with sex steroid deficiency, amenorrhea, infertility, and elevated serum gonadotropins. This work aimed to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) transplantation in women suffering from POF. Out of 112 high risk patients for POF, 10 cases were diagnosed as POF. The ten POF patients were scheduled for MSC transplantation at Al- Azhar University Hospitals. MSC preparation from the bone marrow of the iliac crest was laparoscopically injected in the ovaries. Endometrial fractional biopsy is histopathologically (HP) and Immunohistochemically (IH) stained and evaluated according to Edessy stem cells score (ESS) (1).

Eligibility criteria: Inclusion Criteria:

* Post-menarche female less than 40 years old.
* Normal karyotyping female.
* Primary ovarian failure females
* Follicle-stimulating hormone (FSH) more than or equal to 20 IU/L.
* Agree to sign the designed consent for the study.

Exclusion Criteria:

* Autoimmune diseases.
* Breast cancer, ovarian cancer.
* Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs.
* Those with major medical problems such as malignancy, hepatitis, etc.

Primary outcomes:
measure: Number of cases go through menstruation, pregnancy and labour after stem cell transplantation in POF.
timeFrame: 128 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University
Study officials:
affiliation: Al-Azhar University
name: Mahmoud Edessy, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Hala N Hosni, Professor
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Yousef Shdy, MD
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Syed Bkry, MD
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Medhat Kamel, Msc
role: STUDY_CHAIR
References:
Clinical trial NCT00924274: Effect of Rapeseed Oil and Sunflower Oil
Official title: Effect of a Diet With Rapeseed Oil /Sunflower Oil on Lipoprotein in Children and Adolescents With Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Familial Hypercholesterolemia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-06-18
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Familial hypercholesterolemia (FH), an inherited disorder of lipoprotein metabolism, is a risk for early cardiovascular disease (CVD). This autosomal dominant disease is characterized by markedly elevated plasma concentrations of low density lipoprotein (LDL) and total cholesterol (TC). The purpose of this study is to compare the effect of a diet low in saturated fats but enriched either with rapeseed oil (RO) or sunflower oil (SO) in children and adolescents with FH on serum lipoproteins.


Eligibility criteria: Inclusion Criteria:

* chilren and adolescents between 6 and 18 years of age
* LDLc \> 130 mg/dl and
* TC \> 200 mg/dl
* 7 day nutrition record
* written informed consent

Exclusion Criteria:

* overweight
* underweight
* mental disability
* drug therapy

Primary outcomes:
measure: Blood analysis including fasting serum lipoproteins (TC, LDLc; HDLc; TG, Lp(a), Apolipoprotein A-1, Apolipoprotein B, BB, hs-CRP, GOT, GPT, GGT, acid composition of plasma lipids.
timeFrame: done in Week 1, Week 7, Week 13
Secondary outcomes:
measure: Motivation, compliance, increase of quality of life.
timeFrame: done in Week 1 and Week 13
measure: Acceptance and approach to the disease.
timeFrame: done in Week 1 and Week 13
measure: Improvement of knowledge and understanding about the disease by the patients.
timeFrame: done in Week 1 and Week 13
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Division of Nutrition and Metabolism, Department of Pediatrics, Medical University of Vienna
Study officials:
References:
Clinical trial NCT06505174: Effect of Treatment With Systane Ultra in Symptomatology and Visual Task Efficiency in Digital Device Users
Official title: Effect of Treatment With Systane Ultra in Symptomatology and Visual Task Efficiency in Digital Device Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Digital Eye Strain
Computer Vision Syndrome
OSDI
Lead sponsor: University of Valladolid
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: This study assessed the effect of one month of use of preservative-free artificial tears (Systane Ultra UD, Alcon) on symptomatology related to digital eye strain (DES), visual task performance, and tear film stability in visual display terminal users.

Detailed description: Visual display terminal users (\>4h/day) with DES (CVSS17 score: ranged 29 to 42) and dryness (OSDI score: ranged 13 to 24) symptomatology were prescribed with preservative-free artificial tears (Systane Ultra UD, Alcon) four times a day for one month collecting OSDI and CVSS17 questionnaires in four visits \[screening (Day -7), initial (Day 0), one week (Day 7) and one month (Day 30)\].

Blink rate and number of eye fixations (collected with eye-tracker) in six simple computer tasks and out-loud reading speed were determined before and after performing all tasks on the computer. Tear film stability and ocular parameters were also measured.

Eligibility criteria: Inclusion Criteria:

* Volunteer subjects of legal age will be included who agree to participate in the study after being informed by the researcher, receiving the information sheet and signing the informed consent.
* Eye discomfort related to dryness (OSDI score ranged from 13 to 24)
* Symptomatic digital device users (CVSS17 score ranged from 29 to 42 points - stages 3 and 4)
* Use of computer continuously for at least 4 hours per day (work week)
* Good best-corrected visual acuity (Visual acuity LogMar ≤ 0.00 for distance, intermediate (60cm) and near (40cm))

Exclusion Criteria:

* Systemic administration of drugs with a possible effect on the ocular surface.
* Topical administration of any drugs that can alter the ocular surface.
* Use of contact lenses
* Use of artificial tears or lubricants at least 7 days before inclusion in the study (recruitment visit).
* Any other ocular pathology or binocular conditions which may cause discomfort (e.g. heterophoric, accommodative, and eye movement disorders)

Primary outcomes:
measure: OSDI Score
timeFrame: One month
measure: CVSS17 Score
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: IOBA Eye Institute
Study officials:
References:
Clinical trial NCT05661474: Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers
Official title: The Effects of Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Patients With Diabetic Foot Ulcers: a Monocentric, Two-arm, Open-label, Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Foot
Keywords: diabetic foot
dressing
medication
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes Mellitus (DM) is one of the most widespread metabolic diseases and the alarming rise in its prevalence worldwide poses enormous challenges. The microvascular and macrovascular complications of DM heavy impact on longevity and quality of life, and in particular diabetic foot ulcers (DFUs) are among the ten top causes of worldwide disease burden and disability Essential components of the standard care, management, and treatment of DFUs are represented by health education, strict control of blood glucose and cardiovascular risk factors, offloading, local debridement, and adequate dressing. A wide variety of dressing is available, and these include basic contact dressings (low adherence dressings such as saline gauze, paraffin gauze or simple absorbent dressings) and advanced dressings (alginate, hydrogel, films, hydrocolloid, foam).

It is important underline that due to lack of evidence from head-to-head randomized controlled trials (RCTs), the relative effects of any of these dressings in DFUs remain unclear. Consequently, so far clinical evidence supporting the choice for either hydrogel or saline gauze dressing, has been related mostly on clinician perception rather than high quality evidence. Here we evaluated the efficacy and safety of Fitostimoline® hydrogel dressing versus saline gauze dressing in patients with DFUs in a monocentric, two-arm, open-label, randomized, controlled trial.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes and type 2 diabetes,
* adult patients with DFUs at Grades IC or IIC for a period of at least 12 weeks,
* an akle brachial index \>0.8,
* be able to understand simple instructions,
* provided voluntary, signed informed consent

Exclusion Criteria:

* active infection
* evidence of ischaemia in the limb,
* osteomyelitis,
* gangrene,
* systemic inflammatory or autoimmune disease,
* use of corticosteroids, immunosuppressive agents, radiation therapy and chemotherapyan,
* known hypersensitivity to any of the dressing components.

Primary outcomes:
measure: the proportion of patients complete responders
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Clinical Medicine and Surgery Federico II University
Study officials:
References:
Clinical trial NCT00188474: A Quality of Life Study re Management of Malignant Pleural Effusions
Official title: A Prospective Study of Patient Centered Outcomes in the Management of Malignant Pleural Effusions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Pleural Effusions
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with malignant pleural effusions

Brief summary: There is much data in the literature regarding optimal treatment approaches for malignant pleural effusions as assessed by patient outcomes. However, data on quality of life and satisfaction with treatment from the patient's perspective is not available.

Detailed description: This study will compare various treatment strategies in the management of malignant pleural effusions with respect to:

1. Primary endpoint: the successful palliation of symptomatic pleural effusions as assessed by the London Chest Activity of Daily Living Scale (LCADLS)
2. Secondary endpoints:

   i) impact of treatment on patient quality of life as assessed by the Functional Assessment of Chronic Illness Therapy - Palliative patient (FACIT-PAL) questionnaire ii) Assessment of patient satisfaction with treatment received via Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction (FACIT-TS) questionnaire iii)Pleurodesis success rates assessed by 2 and 6-week effusion control rates on CXR iv) Requirement of further hospitalizations or procedures for the treatment of recurrent effusions v) Comparison of morbidity and mortality rates for differing treatment approaches vi) comparison of cost in a Canadian health care setting for differing treatment approaches

Eligibility criteria: Inclusion Criteria:

* symptomatic pleural effusion
* history of malignant disease
* age greater that 18 years
* consent to participate in study

Exclusion Criteria:

* significant ipsilateral endobronchial disease
* prior ipsilateral, intra-pleural therapy, as defined by: prior chest tube placement for effusion, prior attempt at chemical/surgical pleurodesis, prior surgical pleurectomy
* active pulmonary or pleural infection
* granulocytes \< 1500/mm3, platelets \< 50,000/mm3
* systemic chemotherapy within 2 weeks
* allergy to talc

Primary outcomes:
measure: the successful palliation of symptomatic pleural effusions as assessed by the London Chest Activity of Daily Living Scale (LCADLS)
timeFrame: discharge, 2 wks and 6 wks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Toronto
country: Canada
facility: St. Joseph's Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Gail Darling, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01010074: Retinal Function in Parkinson's Disease
Official title: Intrinsically Photosensitive Retinal Ganglion Cells in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Keywords: retina, Parkinson's disease, ganglion cell, pupillary
Lead sponsor: Edward Hines Jr. VA Hospital
Sponsor class: FED
First posted: 2009-11-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: movement disorders/neurology clinic

Brief summary: Parkinson's disease (PD) is a neurodegenerative disorder characterized by muscle rigidity, tremor, a slowing of physical movement (bradykinesia) and, in extreme cases, a loss of physical movement. The primary symptoms are the results of decreased stimulation of the motor cortex arising from the basal ganglia normally caused by the insufficient formation and action of dopamine, which is produced in the dopaminergic neurons of the brain. Secondary symptoms may include high level cognitive dysfunction and subtle language problems. Included in the symptomatology experienced by patients with PD, visual abnormalities are not uncommon. Visual changes among patients with PD appear not only dynamic in nature, but differentially affected based on the course of the disease and, perhaps more importantly, its treatment. Parkinson's disease has significant ramifications not only in observation of irregularities in vision, but how vision interacts with entrainment of the circadian clock. The purpose of this study is to examine the relationship between PD and operation of a unique set of retinal cells known to regulate the circadian clock and sleep-wake cycles in human subjects.


Eligibility criteria: Inclusion Criteria: age 18-64 best corrected visual acuity of 20/25 or better in each eye -

Exclusion Criteria: evidence of any form of eye disease, inability to understand and sign informed consent.

-

Primary outcomes:
measure: pupillary threshold
timeFrame: one
Secondary outcomes:
Other outcomes:
Locations:
city: Hines
country: United States
facility: Hines VA Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT01510574: A Study of Self-administered Misoprostol to Prevent Bleeding After Childbirth in the Community (MamaMiso)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: postpartum hemorrhage, PPH, misoprostol
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: University of Liverpool
name: Liverpool School of Tropical Medicine
name: Makerere University
name: Mbale Regional Referral Hospital
First posted: 2012-01-16
Enrollment: 749
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postpartum hemorrhage (PPH) is a major cause of maternal death in the developing world. An important strategy in the prevention of deaths is the use of uterotonic drugs for PPH prophylaxis. Misoprostol has been recognized as an option for preventing PPH as it is economical, heat stable, has a long shelf-life, and can be taken orally.

The investigators envisage that the use of self administered misoprostol after home births among mothers would be associated with a peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot).

The objective of the main study will be to assess the effectiveness and safety of antenatal administration of misoprostol tablets (600mcg) for self administration immediately following home delivery for the prevention of postpartum haemorrhage. The objectives of the pilot study are to test the integrity of the study protocol, to test the randomization procedure, to assess the acceptability of the intervention, to test the logistics of follow-up, to test the data collection forms, to validate the quality of life questionnaire in this population and to determine the recruitment rate to help study planning.


Eligibility criteria: Inclusion Criteria:

* pregnant women living in the recruitment villages of Mbale district at \>34 weeks gestation

Exclusion Criteria:

* Any woman with a known allergy to misoprostol or other prostaglandins will be excluded as will any woman under 18 years old (unless she is an emancipated minor)

Primary outcomes:
measure: Change in hemoglobin
timeFrame: Measured during third trimester and 3-5 days postpartum
Secondary outcomes:
measure: Safety
timeFrame: Assessed 3-5 days postpartum
Other outcomes:
Locations:
city: Mbale
country: Uganda
facility: Busiu Health Centre
city: Mbale
country: Uganda
facility: Lwangoli Health Centre
city: Mbale
country: Uganda
facility: Mbale Regional Referral Hospital
city: Mbale
country: Uganda
facility: Siira Health Centre
Study officials:
affiliation: University of Liverpool
name: Andrew Weeks
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00698074: Diastolic Ventricular Interaction and the Effects of Biventricular Pacing in Hypertrophic Cardiomyopathy
Official title: Diastolic Ventricular Interaction and the Effects of Biventricular Pacing in Hypertrophic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
First posted: 2008-06-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary aim of this study will be to assess whether Biventricular pacing improves exercise capacity, and Quality of Life in patients with symptomatic drug resistant Non-Obstructive Hypertrophic Cardiomyopathy, using a Biventricular pacemaker.


Eligibility criteria: Inclusion Criteria:

* Symptomatic Hypertrophic Cardiomyopathy,

Exclusion Criteria:

* Rhythm other than normal sinus Left ventricular outflow tract gradient greater than 30mmHg Inability to exercise v02 max greater than 70% of predicted.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Department Cardiovascular Medicine, University of Birmingham
state: West Midlands
Study officials:
References: