louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06671392: A Phase III Study to Efficacy and Safety of DWC202405/DWC202313 and DWC202314 in Patients with Hypertension
Official title: A Multi-center, Randomized, Double-blind, Parallel Design, Phase III Study to Evaluate and Compare the Efficacy and Safety of DWC202405/DWC202313 and DWC202314 Combination Therapy to DWC202405/DWC202313 in Patients with Essential Hypertension Inadequately Controlled with DWC202405
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 192
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-center, Randomized, Double-blind, Parallel design, Phase III study to Evaluate and Compare the Efficacy and Safety of DWC202405/DWC202313 and DWC202314 Combination Therapy to DWC202405/DWC202313 in Patients with Essential Hypertension Inadequately Controlled with DWC202405


Eligibility criteria: Inclusion Criteria:

* Average systolic blood pressure (MSSBP) and average diastolic blood pressure (MSDBP) measured at the time of screening meet the following criteria (a) If antihypertensive drugs are being administered: 140 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg However, the criteria of 130 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg are applied to patients with the following diseases.

Exclusion Criteria:

* If the blood pressure measured at the time of screening and randomization is MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg
* Those whose blood pressure differences measured on both arms at the time of screening are MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg

Primary outcomes:
measure: change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University ANAM Hospital
Study officials:
References:
Clinical trial NCT04162392: Physical Activity Barriers in AECOPD
Official title: Physical Activity Barriers in Acute Exacerbated COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD Exacerbation
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 40
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: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Patients require good communication with the physician to improve control illness. Shared decision making is a good option to improve physical activity barriers in acute exacerbated COPD patients during the hospitalization period.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were COPD patients hospitalized due to acute exacerbation

Exclusion Criteria:

* Exclusion criteria were the inability to provide informed consent, the presence of psychiatric or cognitive disorders, progressive neurological disorders, organ failure, cancer, or inability to cooperate. Patients who had experienced another exacerbation of COPD in the previous month were also excluded.

Primary outcomes:
measure: Health related quality of life: EQ-5D
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
measure: Functional capacity
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
measure: Barriers to Being Active Quiz
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02647892: Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia
Official title: Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Local Anesthesia
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
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 the optimal amount of lidocaine buffering needed to decrease injection pain when administering local anesthesia.

Detailed description: Once the site is chosen, the skin will be anesthetized as usual. This study will utilize a commercially prepared 1% lidocaine solution mixed with standard sodium bicarbonate. A total of 10 mL will be used.

Eligibility criteria: Inclusion Criteria:

* adults presenting for routine thyroid biopsy, paracentesis or thoracentesis in interventional radiology

Exclusion Criteria:

* Patients requiring sedation
* Patients with altered mental status
* Children
* Patients allergic to lidocaine or sodium bicarbonate

Primary outcomes:
measure: Injection pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Joseph McBride, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skarsvag TI, Wago KJ, Tangen LF, Lundbom JS, Hjelseng T, Ballo S, Finsen V. Does adjusting the pH of lidocaine reduce pain during injection? J Plast Surg Hand Surg. 2015 Oct;49(5):265-267. doi: 10.3109/2000656X.2015.1047780. Epub 2015 May 19.
citation: Bartfield JM, Gennis P, Barbera J, Breuer B, Gallagher EJ. Buffered versus plain lidocaine as a local anesthetic for simple laceration repair. Ann Emerg Med. 1990 Dec;19(12):1387-9. doi: 10.1016/s0196-0644(05)82603-4.
citation: Colaric KB, Overton DT, Moore K. Pain reduction in lidocaine administration through buffering and warming. Am J Emerg Med. 1998 Jul;16(4):353-6. doi: 10.1016/s0735-6757(98)90126-7.
citation: Orlinsky M, Hudson C, Chan L, Deslauriers R. Pain comparison of unbuffered versus buffered lidocaine in local wound infiltration. J Emerg Med. 1992 Jul-Aug;10(4):411-5. doi: 10.1016/0736-4679(92)90269-y.
citation: Matsumoto AH, Reifsnyder AC, Hartwell GD, Angle JF, Selby JB Jr, Tegtmeyer CJ. Reducing the discomfort of lidocaine administration through pH buffering. J Vasc Interv Radiol. 1994 Jan-Feb;5(1):171-5. doi: 10.1016/s1051-0443(94)71478-0.
citation: Machin D, Campbell M, Fayers P, Pinol A. 1997. Sample Size Tables for Clinical Studies, 2nd Edition. Blackwell Science. Malden MA.
Clinical trial NCT02957292: A Study to Compare the Menstrual Bleeding Profile Among Jaydess® and Copper Intrauterine Device (IUD) Users. COLIBRI STUDY (Copper and Levonorgestrel IUD Barcelona Research Initiative).
Official title: A Randomized Controlled Trial to Compare the Menstrual Bleeding Profile Among Copper and 13,5mg Levonorgestrel-releasing IUD Users.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2016-11-06
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The intrauterine device (IUD) is a long-term birth control method that has demonstrated high contraceptive efficacy and effectiveness due to its high compliance, adherence and persistence of use. The IUD has a global prevalence rate around 14% in women of reproductive age.

Side effects are the main reason for IUD use discontinuation. The most common reasons for copper IUD discontinuation are increased menstrual bleeding, irregular bleeding and dysmenorrhea, whereas in the case of 52mg Levonorgestrel IUD are irregular bleeding and amenorrhea.

In 2014, a new hormonal IUD containing13,5mg of Levonorgestrel was marketed in Spain. There are many studies comparing the two Levonorgestrel IUDs. However, there is any study comparing the IUD 13,5mg Levonorgestrel with classic copper IUDs.

The hypothesis of this trial is that Levonorgestrel (13,5mg) IUD users have a menstrual bleeding pattern with fewer days than Copper 380 mm2 IUD users.

This is a Phase IV, national single-center, randomized 1: 1, single-blind, comparative, parallel controled trial.


Eligibility criteria: Inclusion Criteria:

* Healthy female subject.
* Parous or nulliparous women aged between 18 and 45 years who ask for an IUD as a contraceptive method.
* History of regular cyclic menstrual periods ranged from 21 to 35 days with non-excessive menstrual blood loss.

Exclusion Criteria:

* Absolute contraindications to IUD use, according to the World Health Organization Medical Eligibility Criteria.
* Contraindications to use 13,5 LNG-IUD.
* Anemia.
* Use of short or long-acting preparations containing sex hormones within the 12 weeks before the IUD insertion.
* Known bleeding irregularities.
* Pregnancy or breast-feeding.

Primary outcomes:
measure: Number of menstrual bleeding days
timeFrame: 90 days
measure: Amount of Menstrual bleeding
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT01028092: mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation
Official title: mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplant
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Novartis
name: Roche Pharma AG
name: Genzyme, a Sanofi Company
name: Ministry of Health, France
First posted: 2009-12-09
Enrollment: 327
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (\>60 years old) recipients receiving graft from elderly donor(\>60 years old).


Eligibility criteria: Inclusion Criteria:

* Patient who has given written informed consent to participate in the study
* First or second single transplantation of a recipient (male or female) older than 60 years old
* Donor older than 60 years old
* PRA \< 30%

Exclusion Criteria:

* Living donor
* Third transplantation
* PRA \> 30%

Other protocol-defined inclusion/exclusion criteria may apply.

* Recipient of multi-organ transplant
* Active major infections (HBV, HCV, HIV)
* Loss of a first graft for immunologic issues
* Anemia (\<9g/l) or leucopenia (\<2500/mm3)

Primary outcomes:
measure: calculated renal function with MDRD equation
timeFrame: 12 months
Secondary outcomes:
measure: Acute rejection rate
timeFrame: 12 months
measure: Patient and graft survival rate
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
measure: GFR calculated with Cockcroft Gault formula
timeFrame: 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Bordeaux
country: France
facility: CHU Pellegrin - Bordeaux
city: Brest
country: France
facility: CHRU de BREST
city: Caen
country: France
facility: CHU Cote de Nacre
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Dijon
country: France
facility: CHU Dijon
city: Lille
country: France
facility: CHU Lille
city: Limoges
country: France
facility: CHU Limoges
city: Montpellier
country: France
facility: CHU Montpellier
city: Nice
country: France
facility: CHU Nice
city: Paris
country: France
facility: AP-HP Hopital Necker
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: CHU Rouen
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: CHU Rangueil - Toulouse
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CHU de Brest
name: Yannick LE MEUR, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02523092: Use of CXCL9 as a Biomarker of Acthar Efficacy
Official title: Use of CXCL9 as a Biomarker of Acthar Efficacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sarcoidosis
Keywords: sarcoidosis
Acthar
CXCL9
chemokine ligand 9
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2015-08-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective is this study is to test whether use of Acthar gel in the context of sarcoidosis will lead to improved symptoms and lung function and correlate with decreased levels of predictive blood biomarkers, like chemokine ligand 9 (CXCL9).

Detailed description: The investigators will test whether Acthar gel's anti-inflammatory properties will modulate immune cells and lead to decreases in blood biomarkers and improvements in clinical parameters. Specific Aim 1 will examine the levels of the predictive biomarker, chemokine ligand 9 (CXCL9), and related transcripts, and determine whether they decrease in participants over time while taking Acthar. Specific Aim 2 will test whether the biologic changes measured in blood correlate to clinical markers, including lung function and symptom scores. Since the investigators have found that CXCL9 predicts clinical course, they hypothesize that CXCL9 transcript levels in the blood will decrease over time in pulmonary sarcoidosis participants whose clinical outcome measures improve with Acthar.

Eligibility criteria: Inclusion Criteria:

* Biopsy-proven diagnosis of sarcoidosis with demonstrated pulmonary involvement
* Refractoriness to or intolerance of immunosuppressive agents like prednisone or methotrexate

Exclusion Criteria:

* Smoking
* Cancer
* Chronic infections (e.g. tuberculosis, viral, fungal, bacterial)
* Inflammatory conditions
* Coexisting lung disease
* Congestive heart failure
* Uncontrolled hypertension
* Recent surgery
* Active peptic ulcers
* Osteoporosis

Primary outcomes:
measure: Decrease in blood CXCL9 levels by 50%
timeFrame: within 6 months
Secondary outcomes:
measure: Improvement in FVC by 5% of predicted
timeFrame: within 6 months
measure: Improvement in dyspnea score
timeFrame: within 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Laura Koth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Su R, Li MM, Bhakta NR, Solberg OD, Darnell EP, Ramstein J, Garudadri S, Ho M, Woodruff PG, Koth LL. Longitudinal analysis of sarcoidosis blood transcriptomic signatures and disease outcomes. Eur Respir J. 2014 Oct;44(4):985-93. doi: 10.1183/09031936.00039714. Epub 2014 Aug 19.
Clinical trial NCT05912192: The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis
Official title: The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: HOE pharmaceuticals Sdn. Bhd.
First posted: 2023-06-22
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical study is to compare the efficacy of Elonide Nasal Spray to Nasonex Nasal Spray and Placebo (non-active ingredient) in the management of allergic rhinitis.

There are two hypotheses of this study:

1. Elonide nasal spray is same efficacy to Nasonex nasal spray.
2. Elonide nasal spray is more efficient to placebo.

Detailed description: There are several objectives of the study:

1. To compare the efficacy of Elonide to Nasonex and Placebo in treating allergic rhinitis via Quality of life assessments and nasal airflow improvements.
2. To compare the efficacy of Elonide to Nasonex and Placebo in treating allergic rhinitis via symptomatics improvement.
3. To assess the side effect of Nasal spray given.

Patients who meet the criteria to join the study will be randomized in a double-blind manner (patients and investigators). Patients will be given information about the study and consent form, patients will be randomized to 3 treatment group(Elonide, Nasonex, Placebo). Patients will be evaluated before and after treatment in one month time. Patients will be advised to use the nasal spray twice daily.

Eligibility criteria: Inclusion Criteria:

* All adults patients 18 years and above
* Newly diagnosed mild, moderate to severe, intermittent and persistent allergic rhinitis
* Positive skin prick test or serum Immunoglobulin E

Exclusion Criteria:

* Patients who have been on allergic rhinitis treatment
* Below 18 years old
* Patients diagnosed with asthma or immunodeficiency diseases
* Pregnancy
* Other concomitant rhinology disease
* Smokers
* Severe deviated nasal septum

Primary outcomes:
measure: Change from Baseline in Symptoms Score on Allergic Rhinitis at Week 4
timeFrame: Baseline and week 4
measure: Mean difference from Baseline in Quality of Life Questionnaire on several domains at Week 4
timeFrame: Baseline and week 4
measure: Change from Baseline in Total Nasal Resistance while normal breathing at Week 4
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Adverse effect of Nasal Spray
timeFrame: Baseline to week 4
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia
state: Kuala Lumpur
Study officials:
affiliation: Department of Otorhinolaryngology, Faculty of Medicine, Universiti Kebangsaan Malaysia
name: Hardip Singh Gendeh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06079892: Hemorrhoid Radiofrequency
Official title: Evaluation of Radiofrequency Efficiency in the Treatment of Hemorrhoid Pathology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemorrhoid Prolapse
Keywords: radiofrequency
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient suffering for Haemorroidal pathology and requiring a removal procedure to whom a Radiofrequency procedure was performed

Brief summary: Triapedicular haemorroidectomy is currently the gold standard in haemorrhoidal pathology. Minimally invasive surgical techniques now play an important role in the haemorrhoidal management algorithm, particularly for less advanced stages of the disease. Among these techniques, radiofrequency is one of the most recent and is gradually gaining ground. It involves applying a radiofrequency current to the internal haemorrhoidal tissue in order to induce its involution.

The literature has shown that this technique leads to symptomatic improvement in over 60% of cases and a high satisfaction rate, even though some patients still seem to have haemorrhoidal symptoms postoperatively.

The aim of this study is to evaluate the efficacy of this technique in patients with haemorrhoidal pathology operated on at our centre, using "hard" criteria which are thought to be more rigorous ("cure" rather than "improvement").


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Presence of haemorrhoidal pathology
* Patient operated on between March 2017 and March 2023, using the radiofrequency technique
* French-speaking patient

Exclusion Criteria:

* ano-perineal involvement in Crohn's disease
* perianal fistula
* non-quiescent IBD
* radiation-induced rectitis
* psychiatric pathology.
* under guardianship or curatorship
* deprived of liberty
* under court protection
* Patient objecting to the use of his/her data for this research

Primary outcomes:
measure: Evaluation of radiofrequency treatment efficiency
timeFrame: 3 months post procedure
Secondary outcomes:
measure: Measurement of patient satisfaction after surgery
timeFrame: 3 months post procedure
measure: Incidence rate of procedure complication
timeFrame: 3 months post procedure
measure: description of procedure complication
timeFrame: 3 months post procedure
measure: Identification of predictive factor for success
timeFrame: 3 months post procedure
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Hôpital Saint Joseph
Study officials:
References:
Clinical trial NCT02160392: Female Upper Genital Tract in HIV-infected Women
Official title: Virologic, Pharmacologic, and Immunologic Characterization of the Female Upper Genital Tract in HIV-infected Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV
female
genital tract
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 26
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We enrolled HIV-1 positive menstruating women between ages 25-48 years.

Brief summary: The female upper genital tract is a unique compartment involved in HIV pathogenesis.

Detailed description: The persistent detection of HIV in the female genital tract in spite of ART is unexplained, and it is possible the uterine endometrium serve as a reservoir. There are limited data regarding the interaction between HIV expression, antiretroviral therapy (ART) and host immune system in the uterine endometrium.

Eligibility criteria: Inclusion Criteria:

* Regularly menstruating women (between 21-42 days)
* between ages 25-50 years
* Fully suppressed by antiretroviral therapy with plasma HIV RNA \< 40 copies/mL within the last 6 months.

Exclusion Criteria:

* Pregnant or planning pregnancy
* Unwilling to use 2 forms of contraception (condoms + hormonal) if they did not have previous bilateral tubal ligation procedure
* Intrauterine device in place
* Untreated cervical infection (N. gonnorhea, C. trachomatis)
* Taking immunosuppressive medications

Primary outcomes:
measure: Immune characteristics
timeFrame: Single visit approximately 14-42 days after the first day of the last menstrual period.
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Lisa Rahangdale, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: