louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00695318: Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
Official title: A Randomized, Double-Masked, Fellow-Eye Comparison Of The Safety And Efficacy Of 0.2 And 0.5 µg/Day Fluocinolone Acetonide Intravitreal Insert To Sham Injection In Subjects With Bilateral Geographic Atrophy Due To AMD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Keywords: AMD
Age-Related Macular Degeneration
Geographic Atrophy
GA
Lead sponsor: Alimera Sciences
Sponsor class: INDUSTRY
First posted: 2008-06-11
Enrollment: 17
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.

Detailed description: Each patient received a sham injection in one eye and active treatment in the other eye. The eye receiving active treatment was selected based on a randomization schedule.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis bilateral GA secondary to AMD of ≥ 0.5 and ≤ 7 MPS disc areas
* Males and non-pregnant females 55 years old or older

Exclusion Criteria:

* GA secondary to any condition other than AMD in either eye
* History of or current CNV in either eye or the need for anti-angiogenic therapy
* Glaucoma or ocular hypertension (IOP \> 21 mmHg OR concurrent therapy at screening with IOP-lowering agents) in either eye
* Treatment with intravitreal, subtenon, or periocular steroid within 6 months prior to enrollment in either eye
* Any change in systemic steroid therapy within 3 months of screening
* History of vitrectomy in either eye
* Any ocular surgery within 12 weeks of screening in either eye

Primary outcomes:
measure: Change From Baseline in Size of Geographic Atrophy
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Kresge Eye Institute
state: Michigan
Study officials:
References:
Clinical trial NCT04324918: Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis
Official title: Efficacy and Safety of HCP1102 in Patients With Perennial Allergic Rhinitis : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2020-03-27
Enrollment: 174
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis :

A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial


Eligibility criteria: Inclusion Criteria:

* Patients with at least 2 years history of PAR prior to the study
* Positive results of skin prick test
* Patients who provided a signed written informed consent form
* Patients who are able and willing to complete subject diaries
* Patients who agree to maintain consistency in their surroundings throughout the study period

Exclusion Criteria:

* Patients also with non-allergic rhinitis with different causes.
* Patients with severe asthma.
* History of acute • chronic sinusitis within 1 month of Visit 1
* History of intranasal surgeries within 3 months of Visit 1
* Initiation of immunotherapy or dose modification within 1 month prior to Visit 1
* Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1.
* Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug.

Primary outcomes:
measure: Change of Mean Daytime Nasal Symptom Score
timeFrame: base line, 3-4week(2weeks)
Secondary outcomes:
measure: Change of Mean Nighttime Nasal Symptom Score
timeFrame: baseline, 3-4week(2weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital.
Study officials:
affiliation: Gangnam Severance Hospital
name: Kyung-Su Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03876418: Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Official title: Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome: A Single Center Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intra-Abdominal Hypertension
Abdominal Compartment Syndrome
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of intensive surveillance, prevention and treatment of intra-abdominal hypertension in ICU patients. In the first two months patients will be screened and undergo usual care. In the following 10-months patients will have more intensive screening and active measures towards prevention and treatment according to best practices.

Detailed description: Elevated intra-abdominal pressures or intra-abdominal hypertension (IAH) has been shown to be common in all intensive care unit (ICU) patients (upwards of 50%) and has been suggested as the missing link in multi-organ dysfunction, and subsequently ICU mortality. Despite guidelines advocating prevention and surveillance of IAH, adherence remains low in most ICUs across North America and Europe.

The creation of the World Society of the Abdominal Compartment Syndrome (WSACS) in 2004 improved the recognition of IAH/ACS by intensivists. The first consensus guidelines from the WSACS were released in 2006, followed by a 2013 update. Additionally, clinical practice guidelines and recommendations for research were released in 2007 and 2009 respectively, which attempted to standardize research methods and reporting. Unfortunately, even in the 2013 guidelines only WEAK recommendations (by GRADE methodology) could be made regarding the efficacy of surveillance and treatment of IAH/ACS, citing a lack of high quality interventional trials.

The investigator's study aims to assess the feasibility of a larger multi-center interventional trial to investigate the efficacy of aggressive screening, prevention and treatment of IAH in ICU patients.

Eligibility criteria: Inclusion Criteria:

* Adults (\> 18 years of age)
* Admitted to intensive care unit
* Bladder catheter in-situ

Exclusion Criteria:

* Death prior to first IAP pressure measurement
* Pregnancy
* Expected ICU discharge within 24 hours
* Organ donor
* Clinical care team or patient/substitute decision maker declines to enroll patient

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: % of bladder pressure measurements (feasibility)
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: London Health Sciences Center
name: Ian Ball, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05374018: Urinary Antigen Test for Stretococcus Pneumoniae Serotype Prevalence in Community Acquired Pneumonia
Official title: Prospective Study to Evaluate Stretococcus Pneumoniae Serotype Prevalence in Community Acquired Pneumonia in Hong Kong Using a Urinary Kit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumonia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted for CAP

Brief summary: This is an epidemiology study for the prevalence and serotypes of pneumococcus pneumoniae in hospitalized patients with community acquired pneumonia (CAP). The serotypes of the pneumococcus pneumoniae will be determined by a urinary antigen assay


Eligibility criteria: Inclusion Criteria:

Admitted with signs and symptoms suggestive of pneumonia which include one or more of the followings:

1. fever
2. CXR changes with consolidation, increased alveolar shadowing or hazziness
3. respiratory symptoms like increase shortness of breath, cough with sputum Raised inflammatory markers suggesting of bacterial infection with either increased white cell count or C-reactive protein, or both

Exclusion Criteria:

* Nosocomial pneumonia which is acquired \>= 48 hours after hospital admission. Pneumonia which are already known to be caused by pathogens other than pneumococcus pneumoniae.

Primary outcomes:
measure: prevalence of strep pneumonia
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
Study officials:
References:
Clinical trial NCT00929318: Influence of Thyroid Hormones on the Woundhealing Process
Official title: Clinical Investigations on Cytokin-Gradients in Hypo/Euthyroid Patients. Evaluation of Expression of Different Pro-and Anti-Inflammatory Cyto-/Chemokines in Skin Wounds After Surgery of Benign Goitres (Struma Multinodosa) or Malignant Diseases of Thyroid Gland (Papillary Thyroid Carcinoma) in Correlation to the Status of Wound Healing of the Neck Wound
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Neoplasms
Thyroid Carcinoma
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2009-06-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: BASIC_SCIENCE

Brief summary: Main goal of this clinical investigation is to investigate different cytokines in wound fluids of euthyroid vs. hypothyroid patients. As a primary endpoint we want to evaluate if different cytokine levels in euthyroid vs. hypothyroid patients exist and to what extent these cytokines differ. Our targeted cytokines are: IL6, IL10, TNFa and MCP-1. From the literature these 4 factors seem to be the most reasonable to measure and to focus on. Additionally we focus on these 4 factors for financial reasons, technically there wouldn't be a problem to measure more, which is correlated with higher costs. Besides, more than 6 factors would mean larger amounts of sample fluids needed, which would cause technical problems. These factors don't have to change in the same direction. Secondarily, we believe that differences in cytokine profiles of hypothyroidism vs. euthyroidism will correlate to differences in duration and clinical characteristics of the wound healing process.


Eligibility criteria: Inclusion Criteria:

* Near total or total thyroidectomy because of struma multinodsa (nodular goiter) with or without substitution of thyroid hormone after operation
* Total thyroidectomy because of papillary carcinoma of thyroid gland (T1/T2 carcinoma, N1, M0) with planned radio-ablative therapy (RAT) without or with rhTSH

Exclusion Criteria:

* Pat\< 18 years
* Immune disease of thyroid gland (Graves disease)
* Severe immunodeficiency
* Immunosuppressive medication because of solid Organ transplantation
* Hepatitis A/B/C or HIV
* All exclusion criteria for any surgical procedure

Primary outcomes:
measure: Evidence for different cytokine levels in euthyroid vs hypothyroid condition confirmed by bood serum samples
timeFrame: 21 days after surgery
Secondary outcomes:
measure: Differences in duration and clinical characteristics of the wound healing process verified by a modified ASEPSIS score.
timeFrame: 21 days after surgery
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hoochschule Hannover, Allgemein-, Viszeral-und Transplantationscirurgie OE 6220
Study officials:
References:
Clinical trial NCT03920618: Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF
Official title: Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatitis B
Acute-On-Chronic Liver Failure
Keywords: hepatitis b virus
acute-on-chronic liver failure
nucleotide
nucleoside
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.

Detailed description: Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of HBV related ACLF. This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV related ACLF.

Eligibility criteria: Inclusion Criteria:

1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
2. Age from 12 to 65 years old;
3. Serum total bilirubin level \> 10 times upper limit of normal;
4. Prothrombin time activity \< 40% or prothrombin time international ratio \> 1.5；
5. Do not receive nucleotide/nucleoside analogues treatment in the past half year.

Exclusion Criteria:

1. Other active liver diseases;
2. Hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions;
7. Using glucocorticoid;
8. Patients can not follow-up;
9. Investigator considering inappropriate.

Primary outcomes:
measure: Survival rate in the follow-up
timeFrame: 144 week
Secondary outcomes:
measure: Model for end-stage liver disease (MELD) score is recorded after treatment
timeFrame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
measure: Ratio of patients with undetectable hepatitis b virus DNA after treatment
timeFrame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Liang Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03888118: Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke
Official title: Clinical Efficacy of Luna EMG Robot Therapy for Patients After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Luna EMG
drop foot
chronic stroke
Lead sponsor: Rehamed Center
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A lot of studies prove that rehabilitation with the use of modern devices accelerates the recovery of function in patients after stroke. Repeated correct movement patterns affect the central nervous system and stimulating its plasticity. Despite the fact that so many studies confirm the validity of therapy using robots, it is still difficult to assess to what extent its use improves the effectiveness of traditional therapy. In these studies, we want to objectively assess the effectiveness of the Luna device using EMG biofeedback.


Eligibility criteria: Inclusion Criteria:

* patients over 6 months after stroke,
* tibialis anterior strength (Lovett scale) not less than 1 and not greater than 3,
* Ashworth scale in tibialis anterior 0,1, 2

Exclusion Criteria:

* patients less than 6 months after stroke,
* tibialis anterior strength (Lovett scale) 0, 4, 5,
* Ashworth scale in tibialis anterior higher than 2,
* damage to the central nervous system which is another incident,
* serious cognitive deficit,
* stiffness of the ankle.

Primary outcomes:
measure: EMG using the Luna EMG
timeFrame: 3 minutes
measure: EMG using the Luna EMG
timeFrame: 1 minute
measure: Lovett scale
timeFrame: 1 minute
measure: Ashworth scale
timeFrame: 1 minute
measure: Tinetti test - gait and balance
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05068713: High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation A Randomized, Controled, Open and Unicentric Trial.
Official title: High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Transplant; Complications
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 174
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: LIVER PAM

A randomized, controled, open and unicentric trial comparing high (MAP 85-90 mmHg) and low (65-70 mmHg) target of mean arterial pressure in the first 24 hours after liver transplantation.


Eligibility criteria: Inclusion Criteria:

* Older than 18 y
* Admitted in the ICU for a post operative care after liver transplant

Exclusion Criteria:

* Consent refusal
* Liver transplant due to acute liver failure
* Renal transplant ( Previous or concomitant)
* Refusal from the healthcare provider responsible for the patient
* Renal substitution therapy in the prior 15 days
* Pregnancy
* Re-Transplant (Liver transplant in the previous 6 month)
* Hepatorenal syndrome current treatment (Use of terlipressin + Albumin)
* Refractory and persistent shock during or after transplant

Primary outcomes:
measure: incidence of Acute Kidney Disfunction
timeFrame: 7 days
Secondary outcomes:
measure: Mortality
timeFrame: 28 days
measure: re-transplant
timeFrame: 28 days
measure: Lenght of Hospitay Stay
timeFrame: 28 days
measure: Lenght of ICU Stay
timeFrame: 28 days
measure: Days alive and out of hospital in 28 days
timeFrame: 28 days
measure: Substitutive Renal Therapy
timeFrame: 7 days
measure: Days Alive and free of renal disfunction
timeFrame: 28 days
measure: Acute kidney insufficiency according to Urinary NGAL on d0 and D2
timeFrame: 0d and 2d
measure: MAKE28
timeFrame: 28 days
measure: Liver graft primary disfunction ( Initial Poor Function)
timeFrame: 7 days
measure: Liver graft primary disfunction (primary nonfunction)
timeFrame: 10 days
measure: Surgical site infection
timeFrame: 28 days
measure: Need of Transfusion
timeFrame: 7 days
measure: Postoperative Major bleeding in 7 days
timeFrame: 7 days
measure: Incidence of Arrythmia requiring clinical treatment
timeFrame: 7 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São Paulo
state: SAO Paulo
Study officials:
References:
Clinical trial NCT06991413: Impact of an App on the Quality of Life and Symptoms in Individuals With Premenstrual Syndrome
Official title: Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Premenstrual Syndrome-PMS
Keywords: Digital Therapeutics
Premenstrual syndrome (PMS)
Lead sponsor: Endo Health GmbH
Sponsor class: INDUSTRY
First posted: 2025-05-28
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot study explored the effectiveness and acceptance of a digital app for the self-management of PMS. A total of 175 participants were randomized into an intervention and a control group. Findings indicate that the app offers beneficial effects on PMS-specific symptoms and broader health aspects such as fatigue and emotional well-being. The study also provided valuable insights for the design of future larger trials and highlights the promising potential of the app to enhance individualized care.


Eligibility criteria: Inclusion Criteria:

* Legal capacity
* Residency in Germany
* Female gender
* Age ≥18 years
* Diagnosed and medically confirmed current PMS (N94.3)
* Ownership of a smartphone and ability to use it
* Internet access for app usage and questionnaire completion
* Email address for registration
* Willingness to complete questionnaires online
* Motivation for regular app usage
* Sufficient proficiency in the German language

Exclusion Criteria:

* Pregnancy, breastfeeding, or the onset of menopause during the study period
* Changes in hormonal therapy and/or use of antidepressants within eight weeks prior to the study start and/or planned in the upcoming 12 weeks
* Previous or current access to the Endo-App or other comparable digital health applications, or current active prescription
* Current participation in other clinical studies
* Failure to meet the inclusion criteria

Primary outcomes:
measure: PMS-Impact Questionnaire (PMS-I)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chemnitz
country: Germany
facility: Endo Health GmbH
state: Saxony
Study officials:
References: