louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00164970: Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia?
Official title: Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dementia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 166
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Vitamin B12 and folate are essential to brain health. Sub optimal status of vitamin B12 and folate leads to elevation of plasma homocysteine concentration, which is associated with Dementia. Vitamin B12 and folate supplementation improved the cognitive function of demented subjects with hyperhomocysteinaemia in a pilot study.

Objective: To determine the effectiveness of vitamin B12 and folate supplementation in preserving cognitive function of subjects with early dementia

Detailed description: After stratified randomization by mini mental state examination scores, supplement group subjects take 1 mg of methylcobalamin and 5 mg of folic acid daily, while placebo group subjects take placebo capsules. The primary outcome is Mattis dementia rating scale. The secondary outcomes are mini mental state examination, neuropsychiatric inventory, and Cornell scale for depression in dementia. These measurements will be performed at baseline and every six months for 24 months. Fasting plasma homocysteine concentrations are measured at baseline and 18-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Dementia of Alzheimer's or vascular type
* Early dementia defined by Clinical Dementia Rating of 1.

Exclusion Criteria:

* lives alone
* significant communication problems
* significant co-existing diseases
* blood tests:vitamin B12\< 150 pmol/l, serum creatinine\> 250 mol/l, hypothyroidism and syphilis

Primary outcomes:
measure: dementia rating scale
timeFrame: at 6 months, 12 months and 18 months
measure: depression rating scale
timeFrame: at 6 months, 12 months and 18 months
Secondary outcomes:
measure: vitamin b12
timeFrame: at 18 months
measure: folate
timeFrame: at 18 months
measure: homocysteine
timeFrame: at 18 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Chinese University of Hong Kong
state: Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Timothy CY Kwok, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01554670: Radio-frequency (RF)-Based Plasma Micro-tenotomy for the Treatment of Shoulder Impingement Syndrome
Official title: A Prospective Randomized Controlled Study of Radio-frequency Treatment for Shoulder Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rotator Cuff Shoulder Syndrome and Allied Disorders
Keywords: Arthroscopic subacromial decompression
Bipolar radiofrequency
Tendon debridement
Shoulder surgery
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2012-03-15
Enrollment: 65
Sex: ALL
Minimum age (years): 26
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether radio-frequency (RF)-based plasma micro-tenotomy has a positive effective for the treatment of shoulder impingement syndrome with cuff tendinosis. Eighty patients with impingement syndrome and cuff tendinosis that treated arthroscopic were enrolled in the study. Patients were randomly assigned to receive either arthroscopic subacromial decompression alone (ASD group, n=40) or arthroscopic subacromial decompression combined with RF-based plasma micro-tenotomy (RF group, n=40). Clinical outcome data including VAS(Visual Analogue Scale) pain score, Shoulder range of motion (ROM), ASES(American Shoulder And Elbow Surgeons) score, UCLA(University of California, Los Angeles) score, Constant-Murley score and SST(Simple Shoulder Test) score were recorded preoperatively and at postoperative 3-week, 6-week, 3-month, 6-month and 1-year.


Eligibility criteria: Inclusion Criteria:

1. a skeletally mature patient who agreed to participate in the study
2. shoulder impingement syndrome was diagnosed by one senior surgeon (CYJ) and without any sign of rotator cuff tear both on pre-operative MRI or intra-operative arthroscopic view
3. supraspinatous tendinosis was confirmed on preoperative MRI
4. the symptoms were not relieved by a standardized conservative treatment regime
5. patient underwent standard arthroscopic subacromial decompression surgery.

Exclusion Criteria:

1. any concomitant partial or full-thickness rotator cuff tear verified both on pre-operative MRI or intra-operative finding
2. concomitant biceps lesions or internal impingement
3. any history of surgical treatment on the same shoulder.

Primary outcomes:
measure: VAS pain score
timeFrame: postoperative 3-week
Secondary outcomes:
measure: Shoulder range of motion (ROM)
timeFrame: 3-month, 6-month, 1-year
measure: ASES score
timeFrame: 3-month, 6-month, 1-year
measure: UCLA score
timeFrame: UCLA score
measure: Constant-Murley score
timeFrame: 3-month, 6-month, 1-year
measure: SST score
timeFrame: 3-month, 6-month, 1-year
Other outcomes:
Locations:
Study officials:
affiliation: Beijing JST Hospital
name: Chunyan Jiang, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00105170: Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors
Official title: A Phase I, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of hCBE-11, a Humanized Monoclonal Antibody, in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Tumors
Keywords: Monoclonal antibody
Advanced solid tumors
Tumors
hCBE-11
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2005-03-09
Enrollment: 13
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: This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors. This is the first study of hCBE-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. The study duration is two years with treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and long-term follow-up contact every 3 months thereafter.


Eligibility criteria: Inclusion Criteria:

* Relapsed or refractory solid tumors not curable with standard therapy.
* At least one measurable lesion
* ECOG Performance Status less than or equal to 2
* Acceptable hematologic status
* Albumin greater than or equal to 2.5 g/dL
* Normal calculated glomerular filtration rate (GFR)
* Acceptable liver function

Exclusion Criteria:

* Uncontrolled cardiac disease, angina, congestive heart failure, or myocardial infarction within 6 months prior to Study Day
* Known history of hepatitis B or C, or HIV infection
* Clinically significant effusions, including pericardial, pleural, and ascites
* Serious non-malignant disease
* Central nervous system (CNS) metastatic involvement except where the disease has been successfully treated
* Investigational therapies within 4 weeks of Study Day 1
* Radiation therapy of tumors to be followed for this study
* Chemotherapy, biologic therapy, or major surgery other than diagnostic within 4 weeks prior to Study Day 1
* Current Grade 3 or 4 neurological toxicity
* Concurrent anti-neoplastic therapy and/or steroids

Primary outcomes:
measure: To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors
timeFrame: up to 2 years
Secondary outcomes:
measure: To define the recommended Phase II dose of hCBE-11
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06518070: Results Comparison of Cervical Cancer Early Detection Using Cerviray With VIA Test
Official title: Results Comparison of Cervical Cancer Early Detection Using Cerviray With VIA Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: cervical cancer
cerviray
via test
early detection
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 44
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women of childbearing age who would be screened for cervical cancer in West Java Province

Brief summary: Cervical cancer, primarily caused by Human Papilloma Virus (HPV), is a significant global health concern, ranking as the fourth most common cancer in women worldwide. In Indonesia, it stands as the second most frequent cancer among women. This study investigates the performance of Cerviray® AI and Cerviray® AI Evaluation, an artificial intelligence (AI) technology for diagnosing cervical cancer, aiming to compare its sensitivity, specificity, positive predictive value (PPV), and area under the receiver operating characteristic curve (AUC ROC) with the Visual Inspection with Acetic Acid (VIA) test.

Detailed description: The study involved 44 patients from various health centers in West Java Province. Cerviray® AI, Cerviray® AI Evaluation, and VIA tests were administered to high-risk women of childbearing age.

Eligibility criteria: Inclusion Criteria:

* high-risk women of childbearing age who would be screened for cervical cancer (by Cerviray AI examination, Cerviray AI evaluation, and VIA test) at 1 clinic and other 4 health centers

Exclusion Criteria:

* incomplete data
* patient refusing to be examined
* patient refusing to participate in the study

Primary outcomes:
measure: Cerviray AI
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Padjajaran University
Study officials:
References:
Clinical trial NCT03855670: The Role of Physical Activity for Acute Exacerbations of COPD
Official title: The Role of Physical Activity, Malnutrition and Sarcopenia for the Prediction of Acute Exacerbations and the Evolution of COPD Assessment Test (CAT) in Patients With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 42
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: The study cohort will be selected by the Cantonal Hospital St. Gallen (primary care clinic)

Brief summary: The investigators plan to study the association between physical activity, malnutrition and sarcopenia and the occurrence of acute exacerbations of COPD / the evolution of the COPD assessment test (CAT) over 1 year in a telehealthcare cohort of patients with COPD. The investigators hypothesize that malnutrition and/or sarcopenia at baseline and a decline in the fat-free mass index over time is associated with an increased rate of acute exacerbations of COPD and an increased CAT score meaning a higher risk for mortality, morbidity and impairment of quality of life.


Eligibility criteria: Inclusion Criteria:

* COPD GOLD stage B or higher
* Written informed consent

Exclusion Criteria:

* Inability to provide written informed consent
* Insufficient knowledge of the trial language

Primary outcomes:
measure: Rate of acute exacerbations of COPD
timeFrame: 12 months
Secondary outcomes:
measure: Physical activity
timeFrame: 12 months
measure: Fat-free mass index
timeFrame: 12 months
measure: Hand grip strenght
timeFrame: 12 months
measure: C-reactive protein
timeFrame: 12 months
measure: Total protein
timeFrame: 12 months
measure: Albumin
timeFrame: 12 months
measure: 25-OH vitamin D3
timeFrame: 12 months
measure: COPD assessment test
timeFrame: 12 months
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Lung Center, Cantonal Hospital St. Gallen
state: Saint Gallen
Study officials:
References:
Clinical trial NCT01017770: Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso
Official title: Artemether-lumefantrine Vs Co-formulated Amodiaquine + Artesunate for the Treatment of Uncomplicated Falciparum Malaria: a Randomized Open-label Trial to Evaluate the Effectiveness of the Burkina Faso New Drug Policy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uncomplicated P. Falciparum Malaria in Children
Keywords: Uncomplicated malaria
Lead sponsor: Centre Muraz
Sponsor class: OTHER
Collaborators: name: Institute of Tropical Medicine, Belgium
First posted: 2009-11-23
Enrollment: 340
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several countries in Africa have changed their first-line treatment for uncomplicated malaria to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local effectiveness of these drugs when they are given to patients in real life conditions, without direct observation of the drug administration. Thus, this study aims at investigating the effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina Faso.


Eligibility criteria: Inclusion Criteria:

* Weight \> 5 kg;
* Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 parasites /µl;
* Fever (axillary temperature ≥37.5 °C) or history of fever in the preceding 24 hours;
* Haemoglobin value above 5.0 g/dl;
* Absence of febrile conditions caused by diseases other than malaria.

Exclusion Criteria:

* Danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand;
* Signs of severe malaria (WHO 2000);
* Mixed malaria infection;
* Severe malnutrition;
* Other underlying diseases (cardiac, renal, hepatic diseases);
* History of allergy to study drugs;

Primary outcomes:
measure: Polymerase chain reaction (PCR) adjusted treatment failure
timeFrame: Day 28
Secondary outcomes:
measure: Treatment failure up to day 42 (PCR adjusted and unadjusted)
timeFrame: Day 42
measure: Gametocytes (prevalence and density)
timeFrame: At day 7, 14, 21, 28, 35 and 42 days after treatment
measure: Hb changes
timeFrame: Day 35
Other outcomes:
Locations:
city: Nanoro
country: Burkina Faso
facility: Nanoro
state: Boulkiemdé
city: Nanoro
country: Burkina Faso
facility: Nanoro
state: Boulkiemdé
city: Bobo-Dioulasso
country: Burkina Faso
facility: IRSS-DRO/Centre Muraz
state: Bp 545
city: Bobo-Dioulasso
country: Burkina Faso
facility: Tinto Halidou
state: Houet
Study officials:
References:
Clinical trial NCT03705806: Palliative Thoracic ImmunoRT
Official title: Evaluation of Toxicities With Thoracic Radiotherapy and Immune Checkpoint Inhibition in Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer, Nonsmall Cell
Lung Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 30
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: This study will include a population of patients with metastatic NSCLC on first or second line immunotherapy who have an indication for palliative thoracic radiation

Brief summary: The trial is designed as a prospective observational single arm study investigating stage IV non-small cell lung cancer patients who are routinely treated with a PD-1 inhibitor for indications approved by Health Canada. All patients who are selected will be referred for palliative thoracic radiotherapy and treated with a standard dose prescription of 30 Gy in 10 fractions.


Eligibility criteria: Inclusion Criteria:

1. Pathologically confirmed AJCC 7th/8th edition Stage IV adenocarcinoma or squamous cell carcinoma not eligible for curative treatment.
2. Indication and suitability to receive palliative radiotherapy to the thorax (30Gy/10).
3. Receiving or planned to receive nivolumab or pembrolizumab
4. Prior history of systemic chemotherapy is permitted given a washout period of 4 weeks
5. Age 18 or older
6. ECOG Performance Status 0-2
7. Life expectancy greater than 3 months
8. Able and willing to provide informed consent
9. Able to complete patient reported outcome questionnaires

Exclusion Criteria:

1. Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia
2. Previous history of thoracic radiotherapy with an overlapping field
3. Previous history of checkpoint inhibitor related pneumonitis or esophagitis
4. Pregnancy

Primary outcomes:
measure: Rate of Radiation related toxicities
timeFrame: up to 24 months
measure: Patient Report Outcome
timeFrame: up to 12 months
measure: Patient experience and anxiety related to Quality of Life
timeFrame: up to 12 months
Secondary outcomes:
measure: Rate of Survival
timeFrame: 1 year
measure: Rate of Survival
timeFrame: 2 year
measure: Rate of Disease Recurrence
timeFrame: 3, 6, 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Cancer Centre
state: Ontario
Study officials:
References:
Clinical trial NCT01274806: Take-Care Program: Effectiveness of a Physical Therapy Program on Cancer Related Symptoms
Official title: TAKE-CARE: EFFECTIVENESS OF A PHYSICAL THERAPY COMBINING CORE STABILITY EXERCISE AND MASSAGE IN CANCER RELATED SYMPTOMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
physical therapy
massage
core stability
Lead sponsor: Instituto de Salud Carlos III
Sponsor class: OTHER_GOV
Collaborators: name: Universidad de Granada
First posted: 2011-01-12
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Effectiveness of a physical therapy program focussed on core stability exercise and massage as a recovery method in breast cancer survivors after oncology treatment.

Detailed description: Eligibility Criteria

1, had a diagnosis of breast cancer (stage I-IIIA); 2, between 25-65 years; 3, finished co-adjuvant treatment except hormone-therapy; 4, not having active cancer; 5, interest to improve their lifestyle increasing physical activity; and, 6, present 3 to 5 of the following physical findings, judged by the oncologist who referred the patient: neck or shoulder pain symptoms, reduced range of motion in neck- shoulder area, reduced physical capacity, any psychological problem, increased fatigue, sleep disturbances, or any problem in coping with reduced physical and psychosocial functioning.

Principal Outcomes Fatigue Score: Piper Fatigue Scale Mood State:Profile of Mood State Quality of Life: QLQ-BR23

Eligibility criteria: Inclusion Criteria:

* Finished oncology treatment (chemotherapy, radiation, surgery)

Exclusion Criteria:

* Other musculoskeletal conditions.

Primary outcomes:
measure: Change from Baseline in Fatigue Related Cancer at 6 months
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change from Baseline in strength at 6 months
timeFrame: Baseline, six months
measure: Change from Baseline in Quality of Life at 6 months
timeFrame: Baseline, six months
measure: Change from Baseline in profile of mood state at 6 months
timeFrame: Baseline, six months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences
Study officials:
affiliation: Universidad de Granada
name: Manuel Arroyo-Morales, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05576506: Application of Hyperspectral Imaging Analysis Technology in the Diagnosis of Colorectal Cancer Based on Colonoscopic Biopsy
Official title: Application of Hyperspectral Imaging Analysis Technology in the Diagnosis of Colorectal Cancer Based on Colonoscopic Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Colorectal Polyp
Colorectal Adenoma
Colorectal SSA
Keywords: Hyperspectral imaging
Artifitial intelligence
colorectal cancer
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged 18-75 years who undergo the colonoscopy examination and biopsy;

Brief summary: The purpose of this study is to develop and validate a deep learning algorithm for the diagnosis of colorectal cancer other colorectal disease by marking and analyzing the characteristics of hyperspectral images based on the pathological results of colonoscopic biopsy, so as to improve the objectiveness and intelligence of early colorectal cancer diagnosis.

Detailed description: Prospectively collect the hyperspectral image information of ordinary colonoscopic biopsy tissue. The colonoscopic biopsy tissue is from the Endoscopy Center of Qilu Hospital of Shandong University. The hyperspectral images are marked based on the biopsy pathological results, and the deep convolutional neural network (DCNN) model is used. With training and verification, develop the Hyperspectral Imaging Artificial Intelligence Diagnostic System (HSIAIDS) .A portion of colonoscopic biopsy tissue will be collected as a prospective test set to prospectively test the diagnostic performance of the HSIAIDS algorithm.

Eligibility criteria: Inclusion Criteria:

* patients aged 18-75 years who undergo the colonoscopy examination and biopsy

Exclusion Criteria:

* patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in colonoscopy
* patients with previous surgical procedures on the gastrointestinal tract.
* patients with contraindications to biopsy
* patients who refuse to sign the informed consent form

Primary outcomes:
measure: Accuracy of HSI artificial intelligence model to identify colorectal adenoma and cancer
timeFrame: 1 year
measure: Sensitivity
timeFrame: 1 year
measure: Specificity
timeFrame: 1 year
measure: Negative predictive values(NPV)
timeFrame: 1 year
measure: AUC (95% CI)
timeFrame: 1 year
Secondary outcomes:
measure: To record and evaluate any unknown risks and adverse events of hyperspectral imaging in specimen image acquisition
timeFrame: 1 year
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
affiliation: Study Principal investigator
name: Xiuli Zuo, MD,PhD
role: STUDY_CHAIR
References: