louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04643171: Oxidative Stress in Response to Electroacupuncture Against Physical Activity in Diabetic Patients
Official title: Markers of Oxidative Stress in Response to Electroacupuncture Against Aerobic Physical Activity in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OS is an important pathogenetic mechanism for the development of T2DM and its complications.

Oxidative stress is an imbalance of the generation of free radicals or known as reactive oxygen species (ROS) and reactive nitrogen species \[RNS\]) and their neutralization by the antioxidant mechanisms.

Increased levels of ROS and RNS lead to damage of lipids, proteins, and DNA, ultimately causing the destruction of the islet cells of pancreas through apoptosis . Elliptical trainer device is a relatively new modality of exercise and is advertised to be superior to a treadmill because of the low joint impact and the more reasonable costs of an elliptical trainer compared to a treadmill . Additional quantative research is needed to further evaluate the effectiveness of elliptical trainers and the physiological and perceptual responses to the machine Electroacupuncture (EA) is a treatment form of traditional acupuncture in which small electrical currents are passed through needles inserted into the subject's skin using EA stimulator. It seems to have more acceptable results and effects on many important clinical applications and medical research sets .

Detailed description: 60 diabetic patients will be randomly divided to electroacupucture group (30 patients) and high intensity elliptical training (30 patients). the treatment will be done for 5 sessions per week for 12 weeks

Eligibility criteria: Inclusion Criteria:

* type 2 diabetic elderly
* Body mass index less than 30 kg/m2.
* Fasting blood more than 126 mg/dl

Exclusion Criteria:

* cardiac patients
* renal patients
* respiratory patients
* liver patients
* patients who received any complementary therapies within 3 past months

Primary outcomes:
measure: superoxide dismutase
timeFrame: It will be measured after 12 weeks
Secondary outcomes:
measure: nitric oxide
timeFrame: It will be measured after 12 weeks
measure: lipid hydroperoxidase
timeFrame: It will be measured after 12-week training
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00670371: Factors of Importance for the Subjective and Objective Burden of Informal Caregivers to Patients With Functional Psychoses - a Descriptive and Comparative Study
Official title: Factors of Importance for the Subjective and Objective Burden of Informal Caregivers to Patients With Functional Psychoses - a Descriptive and Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Psychoses
Informal Caregivers
Keywords: Caregiver burden
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Psychiatric patients and informal caregivers. Selected from outpatient wards

Brief summary: The objective is to find determinants for the subjective and objective burden of informal caregivers to patients who are requiring continued antipsychotic treatment for functional psychoses among factors related to the patient, the health care and support provision system and the informal caregiver him/her-self.

Detailed description: The study also comprises a descriptive part with the aim:

* To describe clinical characteristics, symptoms, and functioning in the patient group.
* To describe patient resource use in terms of support from the health care and social care sector.
* To describe the socio-economic situation, the general and psychological health, and the coping ability of the informal caregivers.

Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Patients, male or female, aged 18 years or more, suffering or having suffered from a psychotic episode and being in need of continuous antipsychotic medication.
* The respective patient must have at least one informal caregiver.
* Subjects (patients and informal caregivers) must be able to read and write.

Exclusion Criteria:

* Diagnosis of dementia and such cognitive impairment which makes self assessments even with assistance unreliable (patients and informal caregivers).
* Involvement in the planning and conduct of the study (patients and informal caregivers).
* Other concurrent medical condition interfering with ability to complete study (patients and informal caregivers).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bromma
country: Sweden
facility: Research site
city: Danderyd
country: Sweden
facility: Research Site
city: Falkoping
country: Sweden
facility: Research Site
city: Huddinge
country: Sweden
facility: Research Site
city: Lidingo
country: Sweden
facility: Research Site
city: Ljungby
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Solna
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca, MC, Sweden
name: Eva Dencker Vansvik
role: STUDY_DIRECTOR
affiliation: Danderyds Hospital, Stockholm
name: Lena Flyckt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03539471: Current Trend of Epidemiology of Psychiatric Emergency and the Stress of Duty Psychiatric Resident
Official title: Current Trend of Epidemiology of Psychiatric Emergency and the Stress of Duty Psychiatric Resident
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergent Psychiatric, Consultation, Residentship
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NTUH has 4 psychiatric residents each year, from R1 to R4.

Brief summary: Agitation, paranoia, and suicide risk of the psychiatric patients made them difficult to be managed when they visited medical emergency services. The prolonged waiting time at medical emergency services and the stigmatization of psychiatric medicine also made the psychiatric emergency services full of challenges. However, in recent years, the random killings, celebrity suicide and other major social events attracted much attention to the emergency psychiatry.

Following the establishment of the National Health Insurance, the law of mandatory admission, and the prevalence change of all psychiatric diseases, we are now dealing with totally different types of emergent psychiatric conditions, i.e., depression and suicide. However, the real epidemiological data need to be updated. Psychiatric emergency is one of the entrances of the psychiatric network. A comprehensive review of the psychiatric emergency would be needed for the base of further research.

This study is aimed to investigate the prevalence of psychiatric diagnosis of patients who came to Emergency Department of National Taiwan University Hospital and needed a psychiatric consultation. The epidemiological data will be compared to those collected 30 years ago in the same hospital to examine the 30-year trend. On the other hand, the visiting time and the staying time will be analyzed. The stress of on-duty and the contributing factors will be assessed by a 2-hour in-depth interview with psychiatric residents.


Eligibility criteria: Inclusion Criteria:

* Psychiatric resident in NTUH

Exclusion Criteria:

* Major psychiatric illness

Primary outcomes:
measure: Qualitative Research
timeFrame: until 2018/11/1
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT00589771: Saccharomyces Boulardii in Irritable Bowel Syndrome
Official title: Clinical and Cytokine Response to Saccharomyces Boulardii Therapy in Diarrhea Dominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhea Dominant Irritable Bowel Syndrome
Keywords: IBS
Saccharomyces boulardii
probiotics
cytokine
histology
Efficacy
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Biocodex
First posted: 2008-01-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Various studies have been conducted in past using different strains of probiotics in evaluating IBS symptoms. The results are by no means consistent and the overall impact of probiotics in IBS remains unclear. However, recently O'Mahony L et al have shown that Bifidobacterium infantis 35624 alleviates symptoms in IBS; this symptomatic response was associated with normalization of the ratio of an anti-inflammatory to a proinflammatory cytokine (IL-10/IL-12 ratio), suggesting an immune-modulating role for this organism, in this disorder.Saccharomyces boulardii is a probiotic yeast that has been successfully used for the antibiotic induced diarrhea, prevent relapse of Clostridium difficile and Crohn's disease. It ameliorates intestinal injury and inflammation caused by a wide variety of enteric pathogens.We therefore plan a Double-blind, randomized, placebo-controlled study to assess the effects of Saccharomyces boulardii in improving symptomatology of diarrhea predominant IBS and its effect on quality of life. We also plan to assess the changes in the relative production of anti-inflammatory interleukin (IL)-10 to proinflammatory cytokines (IL-12, IL-8 and TNFα).


Eligibility criteria: Inclusion Criteria:

1. Diarrhea-predominant IBS satisfying ROME III criteria.
2. Adults aged 18-70

Exclusion Criteria:

1. Pregnant and lactating females
2. Inflammatory bowel disease and other systemic disease
3. Patients on anti-diarrheal and antibiotics drugs
4. Patients with any ongoing infection
5. Not willing to participate
6. Allergy to any of Saccharomyces boulardii components
7. Central venous catheter carriers
8. Other probiotics e.g., Lactobacillus and Bifidobacterium

Primary outcomes:
measure: Assess the efficacy of Saccharomyces boulardii in reducing clinical symptoms, improving cytokines levels and histology features
timeFrame: 6 weeks
Secondary outcomes:
measure: Assess the efficacy of Saccharomyces boulardii in improving quality of life and safety of the drug
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Zaigham Abbas, FACG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01408771: "Swallow my Urine Back" : Inhibition of Detrusor Overactivity by Swallowing Maneuver
Official title: "Swallow my Urine Back" : Inhibition of Detrusor Overactivity by Swallowing Maneuver
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Detrusor
Keywords: Urodynamics
Overactive Bladder
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-08-03
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are sedignated for urodynamic study with overactive bladder symptoms

Brief summary: The purpose of this study is to find out whether swallowing has an effect on the degree of urinary urgency and on the amplitude of detrusor contraction during filling cystometry in patients with detrusor overactivity (DO).

Detailed description: Consecutive patients with DO will be included in this study. During urodynamics, the amplitude of the waves of DO will be documented and compared. At the beginning of the 2nd wave, patients will be asked to perform 5 repetitive swallows. Following each wave, patients will be asked to grade the severity of the urgency by a visual analogue scale (VAS).

Eligibility criteria: Inclusion Criteria:

patients with DO in filling cystometry

* antimuscarinic medications were requested to stop for 7 days before the cystometry

Exclusion Criteria: none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assaf Harofeh Medical Center, Zeriffin, Israel
name: Kobi Stav, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05207371: Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC
Official title: Phase I / II Clinical Trial of GAIA-102 for Advanced and Relapse NSCLC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cell Therapy
NSCLC
Lead sponsor: GAIA BioMedicine Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-26
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase I Part :

Confirm the safety of GAIA-102 alone or GAIA-102 with pembrolizumab for advanced / relapse non-small cell lung cancer, and decide recommended dose for Phase II.

Phase II Part :

Explore the efficacy and safety of GAIA-102 alone or GAIA-102 with pembrolizumab for advanced / relapse non-small cell lung cancer at the recommended dose of GAIA-102 decided in the Phase I part.

Detailed description: Phase I Part :

The GAIA-102 cohort (Level A1\~A3) and the GAIA-102 + Pembrolizumab cohort (Level B1\~B3) will be implemented in a 3 + 3 design. First, start from Level A1 and set the DLT evaluation period until Day 28 of Cycle 1, and confirm the safety up to Cycle 1_Day 28 of Level A1. After that, Level A2 and Level B1 will be started in parallel. After that, unless MTD is recognized, the safety at each level will be confirmed in sequence, and the recommended doses of Phase II part will be determined.

Phase II Part :

At the recommended number of doses confirmed in Phase I Part, 20 patients will be administered up to 3 cycles, and the safety and efficacy of GAIA-102 alone or with pembrolizumab will be evaluated by ORR.

Eligibility criteria: Inclusion Criteria:

1. Patients who have been confirmed to have NSCLC by histological or cytological examination
2. Patients with ECOG performance status (PS) 0-1 at the time of obtaining consent
3. Patients aged 20 years or older at the time of obtaining consent

Exclusion Criteria:

1. Patients with symptomatological cranial nerve system metastasis. If treatment for cranial nerve system metastasis has already been performed and the neurologically recovered state has been maintained for 2 weeks or more before registration, registration is possible.
2. Patients diagnosed with cancerous meningitis
3. Patients who received allogeneic hematopoietic stem cell transplantation
4. Patients with active autoimmune disease

Primary outcomes:
measure: Phase I part
timeFrame: Cycle 1 (Cycle period is 28 days)
measure: Phase II part
timeFrame: Week 26
Secondary outcomes:
measure: Phase I part
timeFrame: Week 26
measure: Phase I part
timeFrame: 2 year
measure: Phase II part
timeFrame: 2 year
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Kitakyushu Municipal Medical Center
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
Study officials:
affiliation: Graduate School of Pharmaceutical Sciences, Kyushu University
name: Yoshikazu Yonemitsu, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03097471: BPK-S Integration (Ceramic) Post Market Clinical Follow-Up
Official title: Prospektive, Klinische Studie Zur Marktbeobachtung (Post Market Follow-Up Study) Der Knieendoprothese BPK-S Integration Aus Keramikwerkstoff BIOLOX (R) Delta (Prospective Clinical Post Market Follow-up Study of the Total Knee Endoprosthesis BPK-S (Brehm Precision Knee System)Made of Ceramic Material BIOLOX (R) Delta
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Restoration if Knee Joint Function
Lead sponsor: Klinikum Wels-Grieskirchen
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who routinely receive an BKP-S Integration implant made of ceramic are asked to participate.

Brief summary: Post-market prospective clinical study with a medical device. Data from patients that routinely receive a primary BPK-S-integration knee implant made of ceramic will be documented with a follow-up time of 2 years.


Eligibility criteria: Inclusion Criteria:

* Congenital or acquired knee joint defects/deformation which necessitate the implantation of a knee joint replacement
* Defects or malfunctions of the knee joint
* Degenerative, rheumatic, post-traumatic arthritis/arthrosis
* Symptomatic knee instability
* Reconstruction of flexibility
* Patients with material hypersensitivity

Exclusion Criteria:

* Obesity or overweight of the patient
* Acute or chronic infections near the implantation
* Diseases that impair bone growth such as cancer, renal dialysis, osteopenia, etc.
* Sensitivity to foreign matter in the implant materials
* Bone tumors in the area of the implant anchoring
* Illnesses which can be treated without using a knee implant
* Lack of patient cooperation
* Abuse of medication, drug abuse, alcoholism or mental disease
* Pregnancy
* Serious osteoporosis
* Serious damage to the bone and soft tissue structures which impedes stable anchoring and joint function
* Systemic diseases and metabolic disorders
* Overload of the knee implant to be expected

Primary outcomes:
measure: Improvement of Knee Society Score
timeFrame: 12 months
Secondary outcomes:
measure: Improvement of Knee Society Score over the course of the study
timeFrame: 3 months, 24 months
measure: Improvement of EQ-5D (Euroquol 5 dimension) score
timeFrame: 3 month, 12 months, 24 months
measure: Improvement of Oxford Score
timeFrame: 3 month, 12 months, 24 months
measure: Documentation of Complications
timeFrame: 3 month, 12 months, 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02145871: A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy
Official title: A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: Radical Cystectomy
Perioperative Fluid Management
EV1000
14-069
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-05-23
Enrollment: 282
Sex: ALL
Minimum age (years): 21
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 help us learn what is the best amount of fluid to give to patients during bladder surgery in order to avoid delayed bowel function after surgery, which could prolong hospital stay.


Eligibility criteria: Inclusion Criteria:

* Adults (21 years old or greater) who are able to provide informed consent
* Patients who undergo an open, elective radical cystectomy

Exclusion Criteria:

* Patients with active atrial fibrillation or flutter, since the algorithm is not accurate in case of cardiac arrhythmia
* Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test ≤ 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery)
* Presence of ascites, because increased abdominal pressure interferes with EV1000 reading accuracy
* BMI \> 45 or \<17, because increased abdominal pressure interferes with EV1000 reading accuracy

Primary outcomes:
measure: incidence of postoperative ileus (POI)
timeFrame: 3 years
Secondary outcomes:
measure: complications
timeFrame: 1 year post operatively
measure: compare total volume of fluid
timeFrame: the first 72 hours
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Vittoria Arslan-Carlon, MD
role: PRINCIPAL_INVESTIGATOR
References: