louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01441726: Palliative and End-of-life Care in Advanced Dementia: Evaluation of a Program of Organization of Care in Long-term Care
Official title: Palliative and End-of-life Care in Advanced Dementia: Evaluation of a Program of Organization of Care in Long-term Care Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Keywords: Advanced dementia
Quality
Terminal care
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents in long term care settings

Brief summary: Rationale: In Canada, as in most industrialized countries, Alzheimer's disease and other related dementia are increasingly prevalent in older people. At an advanced stage, institutionalization in a long-term care (LTC) setting will be the fate of a majority of patients. A structured palliative care approach is increasingly used for cancer patients, but is still rarely accessible in LTC institutions for older people with advanced or terminal dementia. This approach should include a more systematic detection and treatment of pain and other physical and psychological symptoms during the last weeks of life, as well as better communications between patients, families and care staff, particularly relating to advanced care directives. Objectives: The general objective of this study is to implement and evaluate a multidisciplinary and multidimensional program of palliative and end-of-life care for older persons with terminal dementia in LTC facilities. Methodology: The intervention program will include five components:

1. daily involvement of a nurse from the regular staff in the LTC facility as a change agent;
2. awareness sessions with administrators and staff on the importance of high quality palliative care in dementia;
3. a training program for physicians and all the staff involved in direct care of patients;
4. systematic discussions with families and distribution to families of a document on different aspects of palliative care in dementia;
5. systematic clinical care by regular staff for the control of pain, respiratory symptoms and mouth care. The program will be implemented in two LTC settings (one in Quebec City and one in Sherbrooke, Quebec, Canada), and results will be compared with the LTC control settings where usual care will be applied without implementation of the program.


Eligibility criteria: Inclusion Criteria:

Residents with advanced dementia with a score of 7 on the Reisberg scale

Primary outcomes:
measure: Family satisfaction with terminal care
timeFrame: 1 year
measure: Comfort scale in last two weeks of life
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Centre de santé et de services sociaux de la Vieille Capitale
state: Quebec
Study officials:
References:
Clinical trial NCT04667026: Observational Study on Patients With HIV/AIDS(OSPWH)
Official title: Observational Study of Antiretroviral Therapy Cohort in Patients With HIV/AIDS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Keywords: HIV/AIDS
ART
Lead sponsor: Guangzhou 8th People's Hospital
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 15000
Sex: ALL
Minimum age (years): 14
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 HIV/AIDS who are willing to receive antiretroviral therapy.

Brief summary: To establish a follow-up cohort of antiretroviral therapy(ART) for patients with HIV/AIDS, to observe the ART efficacy and adverse reactions, complications in the process of ART, as well as mortality and causes of death, so as to provide basis for further improving ART efficacy and quality of life of the patients.

Detailed description: 1. To establish a follow-up cohort of ART for HIV/AIDS patients: follow-up points: before treatment and 1, 2, 3 months after treatment, and every 3 months after treatment.
2. To observe the ART efficacy and adverse reactions: The clinical manifestations, laboratory and auxiliary examination indexes of each follow-up time point was observed in the follow-up cohort, including blood routine, liver function, renal function, blood lipid, blood glucose, urine routine, plasma HIV RNA,CD4 cell count, hepatitis index and syphilis index, etc. If HIV RNA is more than 1000 copies/ml, after treatment for more than 6 months, peripheral blood 10ml should be retained and drug resistance should be detected.
3. To investigate the complications of HIV/AIDS patients before and after ART.
4. To investigate the mortality and causes of death in patients with HIV/AIDS.

Eligibility criteria: Inclusion Criteria:

* Patients has a history of diagnosis of HIV.
* Receiving antiretroviral therapy.
* Good treatment compliance.

Exclusion Criteria:

* Aged less than 14 years of old.

Primary outcomes:
measure: The rate of virological suppression after antiretroviral therapy.
timeFrame: Year 10
Secondary outcomes:
measure: The CD4+T cell counts after ART.
timeFrame: Year 10
measure: All-cause mortality among HIV/AIDS after ART.
timeFrame: Year 10
measure: The incidence of adverse reactions after ART.
timeFrame: Year 10
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou Eighth People's Hospital
name: Ling-Hua Li, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04253626: Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia
Official title: Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy Related
Anemia, Iron Deficiency
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-02-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the extent to which treatment of iron deficiency anemia beyond 24-34 weeks' gestation of pregnancy with intravenous iron increases hemoglobin compared to oral iron. The investigators will test the hypothesis that pregnant women who are anemic in the second and third trimester are more likely to significantly increase their hemoglobin with intravenous iron as opposed to the usual standard of care, oral iron.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women 18 years old and above
2. Hemoglobin \< 11 g/dL, serum ferritin \< 30 ug/dL and or transferrin saturation (TSAT) \< 20%
3. Between 24-34 weeks' pregnancy
4. Singleton pregnancy
5. Receiving prenatal care at Stanford/LPCH OB clinic and planning to deliver at LPCH
6. Hemodynamically stable

Exclusion Criteria:

1. Patients unable to give informed consent
2. Known allergy/hypersensitivity to IV iron
3. Inflammatory Bowel Disease or history of gastric bypass surgery
4. Dialysis-dependent Chronic Kidney Disease/ ESRD
5. Known Hemoglobinopathies such as sickle cell disease, beta-thalassemia, alpha thalassemia
6. Folate/Vitamin B12 deficiency
7. Known malignancy
8. Medication allergy to Tylenol (acetaminophen)
9. Hemoglobin above 12 or less than 7 g/dL
10. Patients with complex past medical histories which may include history of multiple medication allergies (greater than 2 allergies), connective tissue disorder, etc.
11. Diagnosis of placenta previa

Primary outcomes:
measure: Mean Change in Hemoglobin value before and after intervention
timeFrame: From the date of randomization to four weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine/Lucile Packard Childrens Hospital
state: California
Study officials:
affiliation: Stanford University
name: Deirdre Lyell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00819026: Observational Trial of Hepatitis C Virus Infected Patients on Calcineurin Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2009-01-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: solid organ transplant patients

Brief summary: Hepatitis C Virus is constantly evolving genetically, particularly in response to the immune system. This is an observational study to examine if immunosuppressants particularly calcineurin inhibitors taken by transplant patients in order to avoid organ rejection causes predictable changes in the genetics of this virus that might be important in order to treat it effectively.


Eligibility criteria: Inclusion Criteria:

* HCV infected on immunosuppression

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Robert Striker
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ansari IU, Allen T, Berical A, Stock PG, Barin B, Striker R. Phenotypic analysis of NS5A variant from liver transplant patient with increased cyclosporine susceptibility. Virology. 2013 Feb 20;436(2):268-73. doi: 10.1016/j.virol.2012.11.018. Epub 2013 Jan 2.
Clinical trial NCT01125826: Cell Culture of Glioma Specimens for in Vitro Preclinical Studies
Official title: Primary Cell Culture of Surgical Glioma Specimens for Invitro Preclinical Studies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Tumor
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18 years of age or older undergoing surgical resection for gliomas.

Brief summary: The purpose of this study is to culture primary human brain tumor cells with the specific aims of:

1. Develop primary cultures from human brain tumor surgical specimens
2. Determine the genetic and molecular fingerprints of brain tumors that may have prognostic significance
3. Delineate the mechanisms underlying oncogenesis of brain tumors.
4. Perform in vitro assays with brain tumor derived primary cultures to assess the efficacy of novel therapeutic agents.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older undergoing surgical resection for glioma

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
References:
Clinical trial NCT02366026: REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study
Official title: REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV
Keywords: HIV
Lead sponsor: Immune Response BioPharma, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to compare \& evaluate between the treatment groups the changes in decline/reduction of HIV viral load changes in the Remune + Amplivax group vs the Amplivax placebo groups. Additional objectives include changes in WBC White Blood Cell counts \& CD4+ \& CD8+ T cell counts along with increased HIV immunity.

Detailed description: This is a 500 subject Multi Center double-blind randomized, Safety \& Efficacy, HIV/AIDS Phase III study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen \& Amplivax compared to placebo group Amplivax in viral load, and secondarily to examine changes in CD4+ \& CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen + Amplivax on viral replication in adults with HIV-1 infection \& to examine immunogenicity of Remune + Amplivax in a Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune + Amplivax.

Eligibility criteria: Inclusion Criteria:

* Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV.
* Are at least 16 years old (consent of parent or guardian required if under 18 years).

Exclusion Criteria:

* Healthy Subjects
* Currently abuse alcohol or drugs.

Primary outcomes:
measure: The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52
timeFrame: 52 Weeks
Secondary outcomes:
measure: The secondary objective is to evaluate & compare changes in WBC White Blood Cell counts between the treatment groups
timeFrame: 52 Weeks
measure: The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Clinical Site TBA
state: California
Study officials:
affiliation: Immune Response BioPharma, Inc.
name: Richard Bartholomew, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04426526: HIFEM for Arms, Lower Limbs, and Oblique Muscles
Official title: Efficacy of HIFEM Treatments for Strengthening and Toning of Arms, Lower Limbs and Oblique Muscles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Tone Increased
Keywords: muscle strengthening
muscle tone
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.

Detailed description: This study will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of arm, lower limb and oblique muscles. The study is a prospective multi-center open-label four-arm study.

Eligibility criteria: Inclusion Criteria:

* Voluntarily signed informed consent form
* BMI ≤ 30 kg/m2
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
* Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

* Cardiac pacemakers
* Implanted defibrillators, implanted neurostimulators
* Electronic implants
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Application in the head area
* Application in the heart area
* Malignant tumor
* Injured or otherwise impaired muscles
* Fever
* Pregnancy
* Sensitivity or allergy to latex
* Breastfeeding
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over areas of the skin which lack normal sensation
* Scars, open lesions and wounds at the treatment area
* Unrepaired abdominal hernia
* Patients after Cesarean section delivery

Primary outcomes:
measure: Changes in adipose and muscle tissue measured via ultrasound imaging
timeFrame: 7 months
Secondary outcomes:
measure: Patient's satisfaction measured via questionnaires
timeFrame: 7 months
measure: Incidence Of Treatment-Related Adverse Events
timeFrame: 7 months
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Plastic Surgical Associates
state: Colorado
city: New York
country: United States
facility: Juva Skin & Laser Center
state: New York
Study officials:
References:
Clinical trial NCT06883357: The Effects of Home-based Graded Repetitive Arm Supplementary Program Group on Stroke.
Official title: The Effects of Home-based Graded Repetitive Arm Supplementary Program Group on Stroke: the Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Graded repetitive arm supplementary program (GRASP) is a self administrated, home-based rehabilitation program and has been incorporated in Canadian Stroke Best Practice Recommendations. Past studies indicated that the home-based GRASP program could facilitate the motor function and motor recovery and prevent learned nonuse of affected upper limb of stroke patients. There is lacking of research and application of the home-based GRASP program in Taiwan. Therefore, this study aims to explore the effects of the home-based GRASP program, which is mainly executed in the form of group intervention, on the affected upper limb of stroke patients.


Eligibility criteria: Inclusion Criteria:

1. Age is above 20 years old.
2. Onset of first stroke complicated with hemiplegia or hemiparesis.
3. The affected upper limb remains partially voluntary movements including lifting to chest level and holding for five seconds; slight flexion and extension of wrist and hand.
4. Understanding and complying with two-steps commands.
5. Understanding the content of trial and willing to sign informed consent.

Exclusion Criteria:

1. Complicating with other neurological disease.
2. Having Orthopedic diseases affecting the movements of upper limbs.
3. Having symptoms of pain to affect the movements of upper limbs.
4. Unstable vital sign or medical condition.
5. Participating another rehabilitative or drug research meanwhile.
6. Receiving botulinum toxin injection within three months.

Primary outcomes:
measure: Fugl-Meyer Assessment for upper extremity (FMA-UE)
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Jamar Hydraulic Hand Dynamometer (Jamar Dynamometer)
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Action Research Arm Test (ARAT)
timeFrame: From enrollment to the end of treatment at 6 weeks
Secondary outcomes:
measure: Chedoke Arm and Hand Activity Inventory (CAHAI)
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Rating of Everyday Arm-use in the Community and Home Scale (REACH-Scale)
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: From enrollment to the end of treatment at 6 weeks
Other outcomes:
Locations:
city: Hsin-Chu City
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Hsin-Chu Branch
name: Chia-Yi Lin
role: STUDY_DIRECTOR
References:
Clinical trial NCT00509457: GV 1001 Immunotherapy in Patients With Non-small Cell Lung Cancer (NSCLC)
Official title: Immunotherapy in Patients With Non-small Cell Lung Cancer (NSCLC). A Phase II Study of GV 1001 Telomerase Peptide Vaccination in Patients With Locally Advanced NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSCLC, vaccination
Inoperable NSCLC stage IIIA/B in good performance status
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Sorlandet Hospital HF
First posted: 2007-07-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To examine the safety and efficacy of telomerase peptide vaccination ( stimulation of the immune system) in patients with NSCLC after having been treated with conventional therapy with radiotherapy and docetaxel as a radiosensitizer.

Detailed description: Survival in patients with locally advanced, inoperable NSCLC may be improved if local control can be achieved with concurrent chemo radiotherapy .After completed standard chemo-and radiation therapy; the safety and efficacy of vaccination therapy will be measured as time to progression after treatment with GV1001. Analysis of changes in T-cell subpopulations and cytokines in peripheral blood will be performed.

Eligibility criteria: Inclusion Criteria:

* Patients with inoperable NSCLC, disease stage IIIA and stage IIIB, who has received concurrent chemoradiotherapy( typically docetaxel 20 mg/m2 and 3D radiotherapy, 2Gy x 30 within the last 4 weeks.
* No sign of brain metastasis( excluded by MRI of the brain)
* Male or female above the age of 18 years.
* Normal lab. values

Primary outcomes:
measure: To examine if combined chemoradiotherapy in patients with NSCLC followed by vaccination( immunotherapy) will increase the immunological response compared to previous experience
Secondary outcomes:
measure: Number of T cell responders and DTH responders, time to progression of disease
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet - Radiumhospitalet HF
Study officials:
affiliation: Oslo University Hospital
name: Steinar Aamdal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01861626: Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pierre Fabre Dermatology
Sponsor class: INDUSTRY
First posted: 2013-05-23
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the bioequivalence (comparison of the rate and extent of the active substance into the body following single administration of the drugs) between the test product V0057 and a reference product after two single oral administration separate by 7 days.


Eligibility criteria: Inclusion Criteria:

* Healthy male subject aged 18 to 50 years (inclusive)

Exclusion Criteria:

* Presence of any significant medical finding or significant history that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
* Presence of any clinically significant abnormal finding at examination in the Investigator's opinion

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 18 time points up to 72h after administration
measure: Time of Maximum Concentration (Tmax)
timeFrame: 18 time points up to 72h after administration
measure: Area under curve (AUC0-72)
timeFrame: 18 time points up to 72h after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Erfurt
country: Germany
Study officials:
References: