louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06761443: To Evaluate the Safety and Efficacy of Pediococcus Acidilactici PA53 in Relieving Constipation in Adults
Official title: Based on a Randomized, Double-blind, Placebo-controlled Trial, we Evaluated the Safety and Efficacy of Pediococcus Acidilactici PA53 in Relieving Constipation in Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Constipation
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To study the improvement of constipation symptoms, quality of life and mental state, intestinal function, intestinal hormones, inflammation and immunity, and intestinal flora of constipation subjects after 8-week intervention with Pediococcus acidilactici PA53.


Eligibility criteria: Inclusion Criteria:

1. Constipated subjects Subjects (less than 3 bowel movements per week and/or Bristol Scale Types 1 and 2); 2. Be able to complete the research according to the requirements of the test plan; 3. Subjects who have signed informed consent; 4. Subjects (including male subjects) have no family planning and voluntarily take effective contraceptive measures from 14 days before screening to 6 months after the end of the trial.

-

Exclusion Criteria:

1. Short-term use of items with similar functions to the subject, which affects the judge of the result;
2. Those who changed their diet type during the study period;
3. People with severe allergies and immune deficiencies;
4. Women who are pregnant, breastfeeding or planning to become pregnant;
5. Patients with serious diseases of cardiovascular, lung, liver, kidney and other vital organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases;
6. People who have used antibiotics in the past two weeks;
7. People with serious mental and mental illness;
8. Failure to eat the test sample as required, or failure to follow up on time, resulting in uncertain efficacy;
9. Other researchers judged it inappropriate to participate. -

Primary outcomes:
measure: Constipation symptom improvement
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: Department of Nutrition, General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
References:
Clinical trial NCT02516943: The Effects of Using Pathological- Based Guidelines for Arterial Blood Gas Analysis in Patients Aftercardiac Surgery
Official title: The Effects of Using Pathological- Based Guidelines for Arterial Blood Gas Analysis in Patients Aftercardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Gas Analysis
Keywords: Arterial blood gas analysis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 140
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: Blood gas analysis were routinely monitor every 4 hours in our surgical cardiac intensive care unit (SICU). These luxury investigations waste the resources. Therefore we develop a pathological- based guideline for arterial blood gas analysis in patients after cardiac surgery. We test the guideline for its safety and efficacy.


Eligibility criteria: Inclusion Criteria:

* Patient undergone elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Emergency surgery

Primary outcomes:
measure: Number of ABG test
timeFrame: 14 days
Secondary outcomes:
measure: Influence of ABG testing on patients' outcome.
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Sirilak Suksompong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00812643: Excretion of Radiolabelled AZD0837
Official title: An Open, Single Centre Pharmacokinetic (Phase 1) Study of the Biliary Excretion of AZD0837 and Metabolites Following a Single Dose of [3H] AZD0837 Given in the Duodenum Via a Loc-I-Gut Catheter to Young Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is an explorative study and the scientific question to be investigated in this study is if AZD0837 and/or its metabolites AR-H069927XX and AR-H067637XX and other unknown metabolites are excreted into the bile.


Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive

Exclusion Criteria:

* Significant illness, trauma or surgical procedures.
* Clinically significant laboratory abnormalities.
* Clinically significant medical history.

Primary outcomes:
measure: The amounts of total radioactivity excreted in bile. Metabolic profile of AZD0837 excreted in bile and identification of previously unknown metabolites and the amounts of AZD0837, AR-H069927XX and AR-H067637XX in bile.
timeFrame: Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose.
Secondary outcomes:
measure: PK variables of AZD0837, AR-H069927XX, and AR-H067637XX.
timeFrame: Frequent sampling during 24 hours.
measure: Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography.
timeFrame: Some of the safety variables will be followed at each visit, some less frequent.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: Inst för Kirurgiska VetenskaperUppsala Universitet
name: Lars Knutson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01131143: Trial of Provider-to-Patient Interactive Voice Response (IVR) Calls to Improve Weight Management in Community Health Centers (CHCs)
Official title: An RCT of Provider-to-Patient IVR Calls to Improve Weight Management in CHCs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Urban community centers
Obesity
Obesity counseling
Low-cost intervention
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2010-05-26
Enrollment: 1228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study will test the effect of provider to patient interactive voice response (IVR) calls in local Community Health Centers within a weight management program.

Detailed description: We will randomize providers to three groups. Patients whose provider has been randomized to usual care will not receive IVR calls but do have available a guideline-level weight management service in TCL. Groups one and two will receive pre-visit and post-referral calls. The pre-visit call will invite patients who want to discuss weight at their upcoming visit with their provider to remember to do so. The post-referral call will remind patients that they have received a referral and encourage them to schedule a visit with the community based weight intervention program. Patients whose provider has been randomized to group 1 will receive IVR calls using their scheduled and referring provider's voice. Group 2 will receive IVR calls using a standard IVR voice.

Eligibility criteria: Inclusion Criteria:

* Adult patients who have screened positive for overweight or obesity

Exclusion Criteria:

* Patients who have not screened positive for overweight or obesity

Primary outcomes:
measure: Weight loss refer by provider
timeFrame: 6 months
Secondary outcomes:
measure: attendance at program, weight loss
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Center on Aging Research-Regenstrief Institute
state: Indiana
Study officials:
affiliation: Indiana School of Medicine
name: Daniel O Clark, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02675738: Reliability of the Preoperative Work-up in Patients Submitted to Surgery for Cystic Neoplasms of the Pancreas
Official title: Reliability of the Preoperative Work-up in a Prospective Series of Patients Submitted to Surgery for Cystic Neoplasms of the Pancreas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cystic Neoplasms
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from pancreatic cystic neoplasms candidate to surgery

Brief summary: Prospective, observational, cohort study to evaluate the reliability of preoperative work-up of patients submitted to surgery for pancreatic cystic neoplasms, in a tertiary referral center. A comparison between the preoperative diagnostic suspicion and the final pathologic report will be done.


Eligibility criteria: Inclusion Criteria:

* diagnosis of pancreatic cystic neoplasms
* indication to surgery

Exclusion Criteria:

* pregnancy, breastfeeding

Primary outcomes:
measure: Number of cases with confirmed preoperative diagnosis
timeFrame: Through study completion, on average 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Verona
country: Italy
facility: University of Verona Hospital Trust
Study officials:
References:
Clinical trial NCT06807138: AVF Volume Blood Flow Reduction in HD Patients
Official title: AVF Volume Blood Flow Reduction in HD Patients with Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease Stage 5
Heart Failure
Lead sponsor: Moscow Regional Research and Clinical Institute (MONIKI)
Sponsor class: OTHER_GOV
First posted: 2025-02-04
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients receiving maintenance hemodialysis treatment

Brief summary: Heart failure with preserved / high cardiac output is a well-known syndrome in patients with high-flow arteriovenous fistula (AVF). However, the threshold for classifying an AVF as high-flow is currently undefined. Cardio-fistular recirculation (CFR) is often used as a criterion, with values greater than 25-30% considered cardiotoxic and associated with adverse outcomes. Additionally, CFR is one of the few easily modifiable risk factors through surgical reduction of AVF volume blood flow (Qa).

The study aimed to evaluate the extent of involution of heart structural and functional changes following Qa reduction in patients with heart failure and CFR \> 25%.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* age \> 18 years
* CKD 5D
* Native arteriovenous fistula or vascular graft
* Heart failure with preserved CO (NYHA I-IV )
* Cardio-fistula recirculation ≥ 25%
* eKt/V \> 1.2
* Absence of arrhythmias (except grade I AV block)
* Absence of valvular disease (except mitral regurgitation I-II)
* Arteriovenous fistula blood flow reduction surgery

Exclusion Criteria:

* Death
* Kidney transplantation
* Conversion of vascular access to central venous catheter
* Withdrawal of informed consent

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: Before and at 6 months after surgery
measure: Estimated pulmonary artery pressure
timeFrame: Before and at 6 months after surgery
measure: E/A ratio
timeFrame: Before and at 6 months after surgery
Secondary outcomes:
measure: NT-proBNP serum concentration
timeFrame: Before and at 6 months after surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Regional Research and Clinical Institute
Study officials:
References:
Clinical trial NCT05253638: Evaluation Of Serum MIF Level in SLE Patients
Official title: Evaluation Of Serum MIF Level in SLE Patients and It's Association With Disease Activity and Severity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Systemic lupus erythematosis (SLE) is a chronic autoimmune disease characterized by production of autoantibodies and the deposition of immune complexes, affecting a wide range of organs. The clinical onset of SLE derives from the interaction between genetic predisposition and environmental, immunological and hormonal factors, with a strong predilection for women of childbearing age.

SLE is usually diagnosed in young women in the third decade of life and represents the leading cause of systemic disease with secondary kidney involvement. Lupus nephritis (LN) occurs in \~50% of patients with SLE and is the most common, but not the only, cause of kidney injury in SLE. LN typically develops early in the disease course, generally within the first 6 to 36 months, and may be present at initial diagnosis.

Macrophage migration inhibitory factor (MIF) is a pleiotropic inflammatory cytokine with regulatory roles in innate and adaptive immunity and is implicated in the pathogenesis of autoimmune diseases including SLE.

MIF actively participates in multiple stages of the inflammatory response, acting on cells directly and/or potentiating the effects exerted by other stimuli. MIF overcomes the inhibitory effects of glucocorticoids on TNF alpha, IL-1 beta, IL-6, and IL-8 production.

MIF is implicated in the pathogenesis of other autoimmune diseases including rheumatoid arthritis (RA), type 1 diabetes, multiple sclerosis and Guillain Barré syndrome.


Eligibility criteria: Inclusion Criteria:

* Adult SLE patients \>18 years
* fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria

Exclusion Criteria:

* Patients with overlap syndrome, pregnancy, active infection, diseases other than SLE that might produce abnormal proteinuria.
* Individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, scleroderma, mixed connective tissue disease).

Primary outcomes:
measure: level of Serum Macrophage Migration Inhibitory Factor Level in Systemic Lupus Erythematosus Patients and Its Association with Disease Activity and Severity
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01226238: Online Self-help for Depressed Patients Awaiting Psychotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2010-10-22
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with major depression who are on a waiting list for psychotherapy usually suffer from considerable symptoms. Online self-help is one potential way to alleviate this suffering. The investigators want to study if patients awaiting psychotherapy benefit from online-self help. The investigators therefore randomly assign patients to either online self-help or no intervention and assess their depressive symptoms on a regular basis. The investigators hypothesize that online self-help will be superior to no intervention in alleviating depressive symptoms in depressed patients awaiting psychotherapy.


Eligibility criteria: Inclusion Criteria:

* Major Depressive Disorder
* stable medication
* 18yrs. or older

Exclusion Criteria:

* current psychotherapy
* acute suicidality
* unavailability of internet connection

Primary outcomes:
measure: Depressive Symptomatology
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Depressive Symptomatology
timeFrame: 6 weeks, up to 10 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: MVZ Falkenried
Study officials:
References:
citation: Klein JP, Roniger A, Schweiger U, Spath C, Brodbeck J. The association of childhood trauma and personality disorders with chronic depression: A cross-sectional study in depressed outpatients. J Clin Psychiatry. 2015 Jun;76(6):e794-801. doi: 10.4088/JCP.14m09158.
Clinical trial NCT00264238: Memantine Augmentation in Obsessive-Compulsive Disorder
Official title: An Open-Label Trial of Memantine to Augment Response in the Treatment of Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-12-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether memantine is safe and effective when used as an augmentation to standard treatment for Obsessive-Compulsive Disorder (OCD).

Detailed description: The purpose of this study is to determine whether memantine (Namenda), in doses up to 20 mg/day, will be effective in treating the OCD of adult patients who have not responded to their OCD medication. Memantine is not FDA approved for OCD, but is approved for the treatment of Alzheimer's Disease. Memantine appears to work by regulating the activity of glutamate, one of the brain's specialized messenger chemicals, which may play a role in OCD. All patients in the study will receive memantine; no one will receive placebo.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* suffering from OCD
* Y-BOCS score of 18 or greater
* taking a therapeutic dose of an anti-OCD medication specified in the protocol

Exclusion Criteria:

* diagnosed with a mental disorder other than OCD
* taking tiagabine or pregabalin
* having had a previous trial of memantine
* receiving therapy for OCD
* substance abuse in the last 6 months
* personality disorders sufficiently severe to interfere with study participation

Primary outcomes:
measure: Mean Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) From Baseline to End of Treatment (12 Weeks)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to End of Treatment (12 Weeks)
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: John J Barry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aboujaoude E, Barry JJ, Gamel N. Memantine augmentation in treatment-resistant obsessive-compulsive disorder: an open-label trial. J Clin Psychopharmacol. 2009 Feb;29(1):51-5. doi: 10.1097/JCP.0b013e318192e9a4.
Clinical trial NCT05552638: Telecare in Rural Senior Centers
Official title: Feasibility to Embed Telecare in Rural Community Senior Centers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Health Care Utilization
Keywords: telehealth
rural
brain
aging
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre/Post-test design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this project is to assess the feasibility of telehealth stations at community centers as a mechanism to increase healthcare access for older adults living in rural communities.


Eligibility criteria: Inclusion Criteria:

* Age of 21 years or older
* Independently capable to complete electronic survey form
* Cognitive capable to verbalize consent for semi-structured interview

Exclusion Criteria

- Unable to complete an electronic survey form

Primary outcomes:
measure: Feasibility of embedded telehealth stations in senior centers as mechanism to increase healthcare access for older adults.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References:
Clinical trial NCT06493838: Clinical Efficacy of Prophylactic Intravenous Neostigmine and Atropine in Preventing Post-Dural Puncture Headache Among Parturient Undergoing Spinal Anesthesia for Cesarean Section: A Double-blind Randomized Placebo-controlled Trial
Official title: Clinical Efficacy of Prophylactic Intravenous Neostigmine and Atropine in Preventing Post-Dural Puncture Headache Among Parturient Undergoing Spinal Anesthesia for Cesarean Section: A Double-blind Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Acute Pain
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Post dural puncture headache is a distressing issue, many measures tried to treat symptoms but few delt with prevention.


Eligibility criteria: Inclusion Criteria:

* Parturient ladies
* Age ranges from 18 to 35 years old.
* ASA II with elective caesarean section under sub-arachnoid block

Exclusion Criteria:

* BMI \>35
* Refusal to participate
* surgical complications necessitating a blood transfusion
* Emergency caesarean section
* the need for endotracheal intubation or vasopressors
* any contraindication to regional anesthesia (such as a history of persistent cephalgia, convulsions, cerebrovascular events

Primary outcomes:
measure: Incidence of patients with post dural puncture headache
timeFrame: first 5 days post-partum
Secondary outcomes:
measure: Severity of post dural puncture headache
timeFrame: first 5 days post-partum
measure: onset and duration of post dural puncture headache
timeFrame: 5 days post partum
measure: Analgesic request
timeFrame: 24 hours after operation
measure: Analgesc requirements
timeFrame: 2 days after operation
measure: frequency of analgesic doses
timeFrame: 5 days
measure: incidence of complications related to the procedure
timeFrame: 6 hours after procedure
Other outcomes:
Locations:
Study officials:
References: