louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02321371: Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute-On-Chronic Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 73
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: In this study, all patients with ACLF (Acute on Chronic Liver Failure) with grade III/IV HE (Hepatic Encephalopathy) getting admitted in our institute will be enrolled after the fulfilment of inclusion/exclusion criteria and consent of the patient's attendants. Investigation of the patient (as mentioned in the proforma) will be done.

Intervention step 1:

liq Lactulose 100 mL stat followed by 30 mL/ hourly through NG/NJ route + Lactulose enema 3rd hourly - till 4 time soft stool is passed, then 30 mL through enteral route 6th hourly (If patient has no bowel sounds, only enema will be given)

Intervention step 2:

(after 24 hours of introduction of step 1, if no rapid reduction in ammonia to \<70mcg/dL) Randomization to L or R arm R Arm (Addition of Rifaximin) Continuation of Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route L Arm (Lactulose only) Continuation of Lactulose therapy for further 48 hours.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years and above
2. Patients with ACLF with grade III/IV HE

Exclusion Criteria:

1. Patients with prior decompensation
2. Grade I,II HE
3. Chronic HE
4. CV stroke
5. Patients with ammonia level \<70 mcg/dL
6. Patients with Septic shock
7. Pregnant lady

Primary outcomes:
measure: Reduction of ammonia level to <70 mcg/dL within 72 hours of the ammonia reduction treatment.
timeFrame: 3 days
Secondary outcomes:
measure: Reduction of ammonia level to at least 50% of the baseline value within 72 hours.
timeFrame: 3 days
measure: Duration of hepatic encephalopathy post-inclusion.
timeFrame: 10 days
measure: Improvement in hepatic encephalopathy from grade III-IV to II-I at any time within 72 hours of treatment.
timeFrame: 3 days
measure: Liver disease related and overall mortality.
timeFrame: 10 days
measure: Duration of ICU stay.
timeFrame: 10 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Tanmay Vyas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00818571: Pharmacokinetics of Vildagliptin in Mild, Moderate and Severe Renal Impaired Patients
Official title: An Open-label, Parallel Group Study to Determine the PK of 25 and 50 mg OD Single and Multiple Dose Over 14 Days, of Vildagliptin and Its Metabolites in Renal Impaired Patients Compared to Matching Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Renal Impairment
Diabetes
Keywords: Renal impairment
Diabetes
vildagliptin
Galvus
Eucreas
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-01-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients


Eligibility criteria: Inclusion Criteria:

* Patients with mild (CrCl from 50 to ≤80 ml/min), moderate (CrCl from 30 to \<50 ml/min) and severe (CrCl of \<30 ml/min) renal function, preferably type 2 diabetic and matching healthy volunteers CrCl of \>80 ml/min

Exclusion Criteria:

* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications, treatment of a DPP-4 inhibitor 30 days prior to baseline, renal transplant history

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Measure: pharmacokinetics of vildagliptin and its metabolites
timeFrame: 14 days
Secondary outcomes:
measure: Measure: safety assessments will include vital signs, electrocardiograms and adverse events
timeFrame: 14 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00987571: Carpal Tunnel Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Median Nerve Compression
Official title: Carpal Tunnel Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Median Nerve Compression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
median nerve
ultrasound
electrodiagnosis
Normal subjects
Lead sponsor: EMG Labs of Arizona Arthritis & Rheumatology Associates
Sponsor class: OTHER
First posted: 2009-10-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with upper extremity symptoms of pain, numbness, and tingling; Adult subjects with no upper extremity pain, numbness, or tingling

Brief summary: Carpal tunnel syndrome is caused by compression of the median nerve at the wrist. The hypothesis is that ultrasound imaging can be used to visualize nerve compression in carpal tunnel patients during hand activity, and normal subjects will not demonstrate any nerve compression.

Detailed description: Two patients with carpal tunnel syndrome underwent nerve testing to document that they had median nerve abnormality at the wrist. They subsequently had ultrasound imaging of the wrist at rest and during a stress test using hand activity. Two control subjects had nerve testing to prove that they had no nerve abnormality at the carpal tunnel. The carpal tunnel syndrome patients demonstrated nerve compression on the ultrasound images during the stress tests and the normal subjects showed no nerve compression.

Eligibility criteria: Inclusion Criteria:

* Patients must have symptoms consistent with carpal tunnel syndrome and electrodiagnostic testing that demonstrates abnormal median nerve function at the wrist, consistent with carpal tunnel syndrome.
* Normal subjects must have no upper limb symptoms to support carpal tunnel syndrome and normal nerve testing.

Exclusion Criteria:

* Patients excluded if nerve testing was not consistent with carpal tunnel syndrome.
* Normals excluded if nerve testing demonstrated any median nerve abnormality.

Primary outcomes:
measure: Median nerve compressive narrowing on ultrasound imaging in carpal tunnel syndrome patients
timeFrame: 5 months
Secondary outcomes:
measure: No median nerve compressive narrowing in normal subjects
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
affiliation: EMG Labs of AARA
name: Benjamin M Sucher, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04792671: Prevalence and Risk Factors of Women Mental Health Disorders
Official title: Prevalence and Risk Factors of Women Mental Health Disorders in Assiut Governorate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychiatric Problem
Wolman Disease
Keywords: women
mental health
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This is study will take part in the Assiut government primary health centres in community

Brief summary: Perinatal major depressive disorder affects 20% of women, while perinatal anxiety affects 10% of women. Although pharmacological treatment has shown effectiveness, many pregnant women are concerned about potential adverse effects on the fetus, maternal-infant bonding, and child development.. On the other hand, Depressive disorder in women mainly occurs during the first year after childbirth. It takes many forms according to the onset, severity, and duration of the symptoms including; Postpartum blues (PPB), Postpartum depression (PPD), and Postpartum psychosis (PPP). Lack of access to mental health services during the perinatal period is a significant public health concern that may worse outcome.

So, we aimed to study prevalence of women mental health in Assiut governorate and evaluate possible risk factor for it


Eligibility criteria: Inclusion Criteria:

* age 18 years -50 years.
* No previous history of psychiatric, neurological or medical disease

Exclusion Criteria:

* intelligence equation less than 80
* have history of psychiatric, neurological or medical disease

Primary outcomes:
measure: measure the prevalence of DSM 5 psychiatric disorders in perinatal and postnatal
timeFrame: through study completion, an average of 1 year
measure: measure of risk factor of DSM 5 psychiatric disorders in perinatal and postnatal
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sambrook Smith M, Lawrence V, Sadler E, Easter A. Barriers to accessing mental health services for women with perinatal mental illness: systematic review and meta-synthesis of qualitative studies in the UK. BMJ Open. 2019 Jan 24;9(1):e024803. doi: 10.1136/bmjopen-2018-024803.
citation: Sheffield KM, Woods-Giscombe CL. Efficacy, Feasibility, and Acceptability of Perinatal Yoga on Women's Mental Health and Well-Being: A Systematic Literature Review. J Holist Nurs. 2016 Mar;34(1):64-79. doi: 10.1177/0898010115577976. Epub 2015 Apr 20.
citation: Sharma V, Burt VK. DSM-V: modifying the postpartum-onset specifier to include hypomania. Arch Womens Ment Health. 2011 Feb;14(1):67-9. doi: 10.1007/s00737-010-0182-2. Epub 2010 Sep 25.
Clinical trial NCT05580471: A Randomized Control Study of Anti-Adhesion Agent After Colorectal Surgery
Official title: A Randomized Control Study of 4DryField PH Anti-Adhesion Agent After Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesion
Keywords: Adhesion
post-operation
Colorectal surgery
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Use 4DryField

One group use 4DryField before wound closure. One group do not use 4DryField before wound closure.
Primary purpose: PREVENTION

Brief summary: This project is to evaluate the difference of post-operation adhesion severity and adhesion area of patient received 4DryField after colorectal surgery.

Detailed description: This proposal will investigate the effect of the newly anti-adhesive agent 4DryField. Stoma creation is common in complicated colorectal disease. Hartman procedure (End colostomy) is used in patients advanced rectal cancer or severe diverticulitis. Loop colostomy or ileostomy is used in patients need stool diversion for prevent leakage related infection.

4DryField is a powder consisting of sterile hydrophilic microparticles, which is anufactured from highly purified potato starch in a complex process. A unique starch-based medical device is 4DryField® PH (4DryField; PlantTec Medical GmbH, Germany) as it is the only product proven to provide hemostasis and prevent the formation of adhesions. In rat model, the 4DryField acheieve the significant adhesion prevention effectiveness. In gynecologic surgery, 4DryField showed effective adhesion prevention as confirmed at second look laparoscopy. The gel is easilier to applied in the uneven surface of pelvic cavity and peristomy area than other manufacture. The indication of adhesion prevention is approved by TFDA.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing colorectal resection and temporary stoma

Exclusion Criteria:

* - Pregnancy, child, psychiatric disorder, behavior disorder, and prisoner. And those patients can't follow the protocol

Primary outcomes:
measure: Adhesion severity
timeFrame: 0 days
measure: Adhesion extent
timeFrame: 0 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 7-14 days
measure: Complication
timeFrame: 30 days
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang-Ho Hospital
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Tungcheng Chang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06222671: A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients With Non-radiographic Axial Spondyloarthritis (Nr-axSpA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Axial Spondyloarthritis
Keywords: non-radiographic axial spondyloarthritis
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-25
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect and safety of 608 in patients with nr-axSpA.

Detailed description: The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo in patients with nr-axSpA.

Eligibility criteria: Inclusion Criteria:

1. Female and male patients at least 18 years of age at the time of screening.
2. Diagnosis of axial spondyloarthritis according to Ankylosing Spondylo Arthritis International Society (ASAS) axial spondyloarthritis criteria
3. Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
4. Total back pain as measured by NRS ≥ 4 at baseline

Exclusion Criteria:

1. Patients with other uncontrolled active inflammatory diseases.
2. Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
3. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
4. History of cancer.
5. Known or suspected history of immunosuppression.
6. Known with allergic or intolerant to mometasone furoate spray or 608/placebo.

Primary outcomes:
measure: The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response
timeFrame: From Baseline to Week 16
Secondary outcomes:
measure: The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response
timeFrame: From Baseline to the Week 16
measure: 608 Concentration in Serum
timeFrame: From Baseline to Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Site 01
state: Beijing
city: Beijing
country: China
facility: Site 03
state: Beijing
city: Chongqing
country: China
facility: Site 05
state: Chongqing
city: Zhengzhou
country: China
facility: Site 02
state: Henan
city: Nanjing
country: China
facility: Site 04
state: Jiangsu
city: Shenzhen
country: China
facility: Site 06
state: Shenzhen
Study officials:
affiliation: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
name: Qinghong Zhou, BS
role: STUDY_DIRECTOR
affiliation: Peking Union Medical College Hospital
name: Xiaofeng Zeng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00247871: Microbiological Characterization and Nasal Carriage Rates of Methicillin Resistant Staphylococcus Aureus (MRSA) in Vancouver Downtown Eastside
Official title: The Prevalence of Panton Valentine Leukocidin, Exfoliative Toxin and Agr Genotypes in Staphylococcus Aureus Nasal Colonization in Vancouver's Eastside Community
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Colonization With MRSA Bacteria
Keywords: MRSA, USA300, CMRSA-10, CMRSA-6, soft tissue abscesses
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-11-02
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Vancouver's Downtown Eastside

Brief summary: We plan to compare data from 300 nasal swab in Vancouver's Downtown Eastside taken in 2001 to data obtained in 2005. The nasal carriage rate of MRSA and the specific characteristic of each MRSA found will be analyzed. A limited amount of associated information will be obtained

Detailed description: MRSA samples will be characterized by pulse field gel electropheresis. An 9 item questionnaire will be administered.

Eligibility criteria: Inclusion Criteria:

Patient had a microbiological sample submitted from the emergency department of the study hospital from 2001- 2005 which grew MRSA.

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Steve Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01222871: Treatment of Early Nasal Polyposis With Topical Triamcinolone
Official title: Treatment of Early Nasal Polyposis With Topical Triamcinolone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Nasal Polyps
Keywords: Treatment
Lead sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor class: OTHER
First posted: 2010-10-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients will be randomized into 2 study groups, experimental and control.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of intranasal Triamcinolone delivered through a bio-absorbable nasal dressing verses oral steroids and a saline soaked dressing, in the treatment and prevention of early nasal polyposis.

Detailed description: nasopore, a bio-absorbable nasal dressing, may offer an alternative route of sustained steroid drug delivery. The use of topical targeted intranasal steroids may prevent the routine adverse effects of oral steroids while maintaining the same therapeutic / clinical efficacy.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Patients with early nasal polyposis

Exclusion Criteria:

* Age \< 18 years
* Patients with active sinus infections
* Patients on long term steroids
* Allergy or sensitivity to steroids
* Patients with Antrochoanal polyps
* Patients who received topical steroids by bio-resorbable sponge or oral steroids

Primary outcomes:
measure: Nasal Endoscopic Exam Findings .
timeFrame: 2 weeks, 6 weeks, 12 weeks were not collected from any participant.
Secondary outcomes:
Other outcomes:
Locations:
city: Brighton
country: United States
facility: St. Elizabeth's Medical Center, 736 Cambridge St
state: Massachusetts
Study officials:
affiliation: Steward St. Elizabeth's Medical Center of Boston, Inc.
name: Peter Catalano, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05416671: The Effect of Guided Narrative Technique on Child Post-traumatic Stress Symptoms Related to Teachers' Improper Criticism
Official title: The Effect of Guided Narrative Technique on Child Post-traumatic Stress Symptoms Related to Teachers' Improper Criticism: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Symptoms
Keywords: Children
Teachers' Improper Criticism
Posttraumatic Stress Symptoms
Expressive Writing
Psychological Intervention
Guided Narrative Technique
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 160
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Teachers' improper criticism may lead to posttraumatic stress symptoms (PTSS) in children. This cluster randomized controlled trial examined the effect of guided narrative technique (GNT) on child PTSS caused by teachers' improper criticism in school settings.


Eligibility criteria: Inclusion Criteria:

* 5th grade students
* 7-13 years old
* with the ability to read and write

Exclusion Criteria:

* younger than 7 years old or older than 13 years old
* having psychotic disorders

Primary outcomes:
measure: change from baseline child posttraumatic stress symptoms at posttreatment
timeFrame: 1 week
measure: change from baseline child posttraumatic stress symptoms at follow-up
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
References:
Clinical trial NCT01274871: Sensory Changes From Chest Drains
Official title: Late Sensory Changes From Chest Drain Insertion During Thoracotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracotomy
Chronic Pain
Keywords: Thoracotomy
Chronic Pain
persistent post-surgical pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-01-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post thoracotomy patients after lung cancer in Denmark

Brief summary: Does chest drains contribute to the post thoracotomy pain syndrome


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Able to cooperate
* able to speak and read Danish

Exclusion Criteria:

* repeat surgery
* cognitive dysfunction
* other nerve injury on the thorax
* abuse (medicine/ alcohol etc)

Primary outcomes:
measure: Pain (NRS)
timeFrame: 3 years postoperatively
measure: Sensory thresholds
timeFrame: 3 years postoperatively
Secondary outcomes:
measure: Psychometrics (HADS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Section for Surgical Pathophysiology 4074
Study officials:
References: