louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01926847: Digital Flow Enhancement in Raynaud's Phenomenon With an sGC (Soluble Guanylate Cyclase) Stimulator
Official title: Single Dose, Double-blind, Placebo-controlled, Single Center, Randomized Cross-over Study to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetic Properties of BAY63-2521 After Oral Dosing in 20 Patients With Raynaud's Phenomenon (RP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Raynaud Disease
Keywords: Digital ischemia
Raynaud's phenomenon
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-08-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Patients with Raynaud's phenomenon suffer from painful attacks triggered by stress or cold causing acute lowering of blood flow through the digits. In this trial the safety and efficacy as well as the effect of one dose of the sGC stimulator Riociguat on digital blood flow will be measured during a cold exposure test in patients suffering from Raynaud's phenomenon. Measurements of two periods will be compared: in one period the patient will be given active drug and in the other period a placebo.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from Raynaud's phenomenon diagnosed at least ≥1 year before beginning of the study of the following origin:

  * idiopathic (primary)
  * limited cutaneous Scleroderma associated
  * diffuse cutaneous Scleroderma associated
  * mixed connective tissue disease associated

Exclusion Criteria:

* Patients taking medication interfering with the digital flow measurement such as calcium channel blockers (CCB), phosphodiesterase 5 (PDE5) inhibitors, endothelin receptor antagonists (ERA), Nitrates
* Smokers
* Systolic blood pressure (SBP) below 105mmHg at rest

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 5 weeks
measure: Blood pressure
timeFrame: 5 weeks
measure: Pulse rate
timeFrame: 5 weeks
measure: Incidence of participants showing changes during clinical laboratory and hematology assessment
timeFrame: From baseline to 5 weeks
measure: Plasma concentration at 2 h after riociguat administration
timeFrame: After 2 hours
measure: Placebo corrected change in digital blood flow at room temperature, measured by Laser Doppler Perfusion Imaging
timeFrame: At baseline and after 2h
measure: Placebo corrected change in digital blood flow during cold exposure, measured by Laser Doppler Perfusion Imaging
timeFrame: At baseline and after 2h
Secondary outcomes:
Other outcomes:
Locations:
city: Köln
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06284447: Barriers to Cervical Cancer Screening
Official title: Barriers to Cervical Cancer Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 2216
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 21-65 that are non-compliant for cervical cancer screening within the Mayo Clinic Health System

Brief summary: This study evaluates barriers to cervical cancer screening among non-compliant women.

Detailed description: PRIMARY OBJECTIVE:

I. To further identify barriers to cervical cancer screening in women, we will identify non-compliant patients and survey them to better understand barriers that have led to inadequate screening.

OUTLINE: This is an observational study.

Participants complete a survey on study.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 21-65
* Non-compliant for cervical cancer screening within Mayo Clinic Primary Care

Exclusion Criteria:

* Women less than 21 or older than 65
* Complaint for cervical cancer screening within Mayo Clinic Primary Care
* Women who decline participation

Primary outcomes:
measure: Identify barriers to cervical cancer screening
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Brittany A. Strelow, DSMc, PA-C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05101447: Pharmacokinetically-driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis
Official title: Pharmacokinetically-driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Lupus Nephritis
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Meta-analyses in adults suggest equivalence of clinical efficacy of intravenous cyclophosphamide and mycophenolate mofetil when dosed based on patient weight or body-surface-area (MMFBSA), as is the current standard for the treatment of proliferative lupus nephritis (LN) treatments in the U.S. Pharmacokinetically-guided precision dosing of MMF (MMFPK) may offer a beneficial modification of the current standard treatment in that MMKPK promises over 30% higher LN response rates than MMFBSA. The objective of the proposed randomized, controlled study is to compare the efficacy and safety of pharmacokinetically-guided precision dosing of MMF (MMFPK) with conventional dosing regimens of MMF (MMFBSA) among children with proliferative LN.


Eligibility criteria: Inclusion Criteria:

New diagnosis with proliferative LN based on kidney biopsy done within 4 weeks of enrollment Diagnosis with childhood-onset SLE (cSLE) as per the ACR criteria95, 96 Age 8 - 17 years at the time of enrollment96 Tolerates oral MMF

Exclusion Criteria:

Perceived or stated inability to adhere to study protocol, Lack of use of highly effective birth control method. Presence of cSLE features that a-priori suggest that the patient benefits from other therapy than that suggested by the study protocol, History of significant kidney disease prior to the diagnosis with cSLE, Need for renal replacement therapy at the time of enrolment, Concurrent therapy with CYC or rituximab.

Primary outcomes:
measure: renal remission
timeFrame: 26 week
Secondary outcomes:
measure: Complete Renal Remission
timeFrame: week 26
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04406077: The Use of Ligasure (r) for Hydrocelectomy Surgery
Official title: The Use of Ligasure (r) for Cutting and Coagulations of Tissues in Hydrocelectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydrocele
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-05-28
Enrollment: 61
Sex: MALE
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain, with interfering with the normal testes function. however, during activity, this can interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for cutting and coagulating tissues during hydrocelectomy.

Detailed description: Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain, with interfering with the normal testes function. however, during activity, this can interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for cutting and coagulating tissues during hydrocelectomy. during the study, males, 18 - 81 who suffer from hydrocele underwent hydrocelectomy using Ligasure (20 cm) without using sutures.

Eligibility criteria: Inclusion Criteria:

* 18 - 81 males
* Diagnosed with unilateral hydrocele

Exclusion Criteria:

* Bilateral hydrocele
* infected hydrocele
* hydrocele secondary to tumor

Primary outcomes:
measure: resolution of hydrocele
timeFrame: Three weeks after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe MC,
Study officials:
References:
Clinical trial NCT06006377: Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies
Official title: Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Disease
Back Pain
Disc Herniation
Keywords: Backup
physiotherapy
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: conventional physiotherapy and backup device therapy
Primary purpose: TREATMENT

Brief summary: Our aim in this study is to examine the effectiveness of the Backup spine health device in spinal problems and compare it with traditional physical therapy methods.

Detailed description: The investigators study was planned as a randomized controlled study. Participants will be divided into 2 groups as conventional physiotherapy and Backup group by simple randomized method. Participants will be taken to a treatment program for 12 weeks, 3 days a week. Parameters such as pain, posture, sleep quality, quality of life, muscle shortening at the beginning and end of the study. The results will be analyzed statistically.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 20-60
* sick individuals with spinal problems
* Persons who have filled out the consent form

Exclusion Criteria:

* People with spinal pathology for whom physiotherapy is contraindicated
* Having a neurological problem

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 14 weeks
measure: World Health Organization Quality of Life Scale Short Form
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Uskudar University
Study officials:
affiliation: Uskudar University
name: Asiye ÖNELGE
role: STUDY_CHAIR
References:
citation: Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234.
citation: Stoll T, Germann D, Hagmann H. [Physiotherapy in lumbar disc herniation ]. Ther Umsch. 2001 Aug;58(8):487-92. doi: 10.1024/0040-5930.58.8.487. German.
citation: Andersen MO, Andresen AK, Lorenzen MD, Isenberg-Jorgensen A, Stottrup C. [Non-surgical treatment of lumbar radiculopathy]. Ugeskr Laeger. 2017 Nov 13;179(23):V05170397. Danish.
Clinical trial NCT01178177: Radiologic Features of Invasive Pulmonary Aspergillosis
Official title: Retrospective Analysis of Radiologic Features of Invasive Pulmonary Aspergillosis in Transplant Recipients and Neutropenic Patients.Transplant Recipients and Neutropenic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Disease
Solid Organ Transplantation
Keywords: Invasive pulmonary aspergillosis
Solid organ transplantation
Hematologic disease
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 130
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients who are diagnosed with invasive pulmonary aspergillosis (IPA)between January 2008 and February 2010.

Brief summary: Invasive pulmonary aspergillosis (IPA) is an opportunistic infection that primarily affects recipients of solid organ transplants (SOTs) and patients with chemotherapy- induced neutropenia.Although both of these populations are at high risk for IPA, they differ with regards to the specific defects in host defense mechanisms that increase their risk for IPA. Chemotherapy- induced neutropenia is the principal defect affecting patients with hematologic malignancies, whereas transplant recipients tend to have dysfunctional T cells and phagocytes, as a result of immunosuppressive drug therapy. Thus, the patterns of IPA-related infection and inflammation may differ according to the type of underlying immune defect. Although the clinical and radiological features of IPA in patients with neutropenia have been extensively studied, little is known about the characteristics of IPA in SOT recipients. The investigators therefore compared the IPA- related clinical and radiological findings in SOT recipients with those of neutropenic patients.


Eligibility criteria: Inclusion Criteria:

* IPA cases with solid organ transplant recipients and hematologic disease patients
* proven and probable invasive pulmonary aspergillosis by modified EORTC/MSG criteria

Exclusion Criteria:

* under 16 years old
* possible cases of invasive pulmonary aspergillosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Infectious Diseases, Asan Medical Center
name: Sung-Han Kim, MD
role: STUDY_CHAIR
References:
citation: Park SY, Lim C, Lee SO, Choi SH, Kim YS, Woo JH, Song JW, Kim MY, Chae EJ, Do KH, Song KS, Seo JB, Kim SH. Computed tomography findings in invasive pulmonary aspergillosis in non-neutropenic transplant recipients and neutropenic patients, and their prognostic value. J Infect. 2011 Dec;63(6):447-56. doi: 10.1016/j.jinf.2011.08.007. Epub 2011 Aug 16.
Clinical trial NCT06267677: Efficacy of Liquid Versus Powder Protein Supplementation to Optimize Protein Intake After Bariatric Surgery
Official title: Efficacy of a Specific Complete Formula on Nutritional Status and Coverage of Protein Requirements After Obesity Surgery Compared to the Traditional Progressive Diet: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Composition
Obesity
Protein Supplementation
Bariatric Surgery Candidate
Weight Loss
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 50
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: The goal of this randomized control trial is to compare the effect of a liquid formula rich in nutrients and low in calories (supplement) with the progressive diet with conventional foods that we usually recommend in patients after surgery. The main question it aims to answer is if the addition of a high-protein, volume-controlled nutritional supplement as a fundamental part of the diet during the first two months after surgery will preserve the patient's nutritional status and prevent the appearance of nutritional deficits and associated complications.

Participants will be evaluated at the beginning, at 1 month and at the end of the study (2m) and the following determinations will be made:

* Analytical determination
* Nitrogen balance by determining urea N2 in 24-hour urine
* Anthropometric determinations
* Body composition determined by impedanciometry
* Resting energy expenditure and nutrient oxidation measured by indirect calorimetry.
* Energy, protein and hydration intake.
* Gastrointestinal tolerance through self-registration of symptoms. Researchers will compare the effect of a complete hypocaloric liquid formula group with the usual progressive diet group to see if they achieve the protein intake goal established for patients after obesity surgery, preservation of nutritional status and lean mass during the rapid phase of weight loss and the gastrointestinal tolerance during the first two months after surgery.


Eligibility criteria: Inclusion Criteria:

Patients of both sexes between 18 and 65 years of age undergoing bariatric surgery in our center With the ability to understand the objectives and proposals of the study That they agree to participate in the study.

Exclusion Criteria:

Patients who have had perioperative complications and who require an extended hospital stay Patients who after the intervention require some type of artificial nutritional support Patients who have undergone a surgical technique other than BPG.

Primary outcomes:
measure: protein intake
timeFrame: 2 months
measure: evaluate nutritional deficiencies
timeFrame: 2 months
measure: Tolerance
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03011177: Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients
Official title: A Randomized, Open Label, Parallel-group, Non-inferiority, Active-controlled, Phase Ⅳ Study to Evaluate the Efficacy and Safety of Teneligliptin Versus Linagliptin in Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type2 Diabetes Mellitus
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-05
Enrollment: 168
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: To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 Diabetes Mellitus patients.

Detailed description: A randomized, open label, parallel-group, non-inferiority, active-controlled, phase IV study

Eligibility criteria: Inclusion Criteria:

* Patients who are 19 years or older on screening
* Patients with type 2 diabetes mellitus
* Patients with 7.0% ≤ HbA1c ≤ 11.0% at the screening visit
* Patients with Fasting Plasma Glucose \<15mmol/L(270mg/dL) on screening

Exclusion Criteria:

-

Primary outcomes:
measure: HbA1c
timeFrame: 12week
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT03713177: Awareness of Systemic Diseases and Its Dental Implications
Official title: Awareness and Knowledge of Systemic Diseases and Its Relevance to Oral Health Care Among Dentists and Dental Interns: Observational Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Awareness of the Relation Between Systemic Disease and Oral Health Conditions
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Dental health care providers in different settings

Brief summary: Implications of systemic diseases on Oral health and their manifestation

Detailed description: Systemic Diseases have oral manifestations and these oral manifestation may affects the treatment plan and may affect the drugs given after dental treatment hence the study aims to assess the awareness and knowledge of systemic diseases and its implications in the dental field

Eligibility criteria: Inclusion Criteria:

* Dentists working for Egyptian ministry of health - Cairo.
* Dental interns of Cairo University.

Exclusion Criteria:

* Those who refused to share information.
* Candidates who refused to sign consent.

Primary outcomes:
measure: degree of awareness among dentists and dental students about systemic diseases and its relevance to oral health.
timeFrame: 1 Year
Secondary outcomes:
measure: Assess their knowledge about dental management of these cases
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Post grad Student at Cairo University
name: Abdelaziz Moussa, Graduate
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tavares M, Lindefjeld Calabi KA, San Martin L. Systemic diseases and oral health. Dent Clin North Am. 2014 Oct;58(4):797-814. doi: 10.1016/j.cden.2014.07.005. Epub 2014 Aug 7.
Clinical trial NCT03863977: Post-operative Analgesic Effects of Dexamethasone Added to Bupivacaine in Transversusabdominis Plane (TAP) Block
Official title: Comparison of Post-operative Analgesic Effects of Two Doses of Dexamethasone Added to Bupivacaine in Ultrasound-guided Transversusabdominis Plane (TAP) Block for Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Analgesia
Keywords: TAP block
inguinal hernia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 patients will be divided into two groups according to the dose of dexamethasone added to bupivacaine in the TAP block, I - group ( Group D4 ) 4mg of dexamethasone will be added II - group ( Group D8 ) 8mg of dexamethasone will be added. III-group(control) bupivacaine alone
Primary purpose: PREVENTION

Brief summary: To compare the postoperative analgesic effect of two doses of dexamethasone added to bupivacaine in ultrasound-guided TAP block for inguinal hernia repair.

Detailed description: The transverses abdominis plane block (TAP block) is a regional anesthesia technique that provides analgesia following abdominal surgery . The TAP block significantly reduces pain after open inguinal hernia repair, regardless of whether it is used as a primary anesthesia technique or as a complement to general anesthesia, spinal or local anesthesia .

The investigators designed this study to compare the postoperative analgesic effect of two doses of dexamethasone( 4 mg and 8 mg ) added to bupivacaine in ultrasound-guided TAP block for inguinal hernia repair.

Eligibility criteria: Inclusion Criteria:

* Patients' age from 18 to 60 years old,
* physical status ASA I-II (by the American Society of Anesthesiologists),
* Elective unilateral open inguinal hernia repair,
* Under spinal anesthesia

Exclusion Criteria:

* age \< 18 or \> 60,
* American society of anesthesiologist (ASA)class III-IV,
* known allergy to amino amide local anesthetics,
* skin infection and diseases at site of injection.
* coagulation disorders,
* patients with body mass index (BMI) \> 35 kg/m2,
* scrotal hernias,

Primary outcomes:
measure: time of the first analgesic request
timeFrame: in the first postoperative 24 hours
Secondary outcomes:
measure: change in visual analog scale (VAS)
timeFrame: 2nd, 4th, 8th, 16th, and 24th postoperative hours.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
state: Assiut Governorate
Study officials:
affiliation: Assiut university, Egypt
name: Amany Hassan, Lectural
role: PRINCIPAL_INVESTIGATOR
References: