louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01097174: CyPass Clinical Experience Study
Official title: A Multicenter Registry Study to Capture Data With Respect to CyPass Clinical Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Angle Glaucoma (OAG)
Keywords: Glaucoma
Glaucoma device
Glaucoma surgery
Intraocular pressure
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-04-01
Enrollment: 555
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma

Brief summary: This study is to evaluate the long-term safety, effectiveness and clinical experience of the CyPass Micro-Stent in patients with glaucoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of OAG
* IOP ≥ 21 mmHg and ≤ 31 mmHg (with or without ocular hypotensive medication)

Exclusion Criteria:

* Acute angle closure, narrow angle, uveitic or neovascular glaucoma
* Normal tension glaucoma

Primary outcomes:
measure: Incidence of intraoperative and postoperative adverse events
timeFrame: Day 0 - Year 3
Secondary outcomes:
measure: Intraocular pressure (IOP) reduction
timeFrame: 1 - 36 months postoperatively
measure: Ocular hypotensive medication use
timeFrame: 1 - 36 months postoperatively
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: University Eye Clinic
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Ophthalmologic Diseases
city: Berlin
country: Germany
facility: Schlosspark-Klinik, Department of Ophthalmology
city: Bochum
country: Germany
facility: Knappschaftskrankenhaus Bochum-Langendreer
city: Cham
country: Germany
facility: AugenKlinik Cham
city: Lubeck
country: Germany
facility: Klinik fur Augenheilkunde, Campus Lubeck
city: Neubrandenburg
country: Germany
facility: Klinik für Augenheilkunde, Dietrich-Bonhoeffer-Klinikum
city: Catania
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazio
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny (Military Medical Institute)
city: Barcelona
country: Spain
facility: Institut Catala de Retina
city: Barcelona
country: Spain
facility: Instituto de Microcirugia Ocular
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Ramón y Cajal University Hospital
city: Zaragoza
country: Spain
facility: Hospital Universiatrio Miguel Servet
Study officials:
affiliation: Transcend Medical, Inc.
name: Tsontcho (Sean) Ianchulev, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01422382: Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin
Official title: Drug-Drug Interaction Study to Assess the Effects of Steady-State Cardizem LA (Diltiazem Hydrochloride) and Steady-State Pitavastatin on Their Respective Pharmacokinetics in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug interaction study.

Detailed description: Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. During the treatment period, each subject will receive a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15. Subjects will fast overnight for at least 8 hours before dosing and will remain fasted until 4 hours after dosing on the morning of Days 5, 10, and 15.

Eligibility criteria: Inclusion Criteria:

* Healthy adult male or female volunteer aged 18 to 45 years, inclusive.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive.
* Subject has normal hematology, serum chemistry, and urinalysis test results.
* Subject is able and willing to abstain from alcohol, grapefruit-containing foods or beverages, caffeine, or caffeine-containing products, St John's wort, and herbal supplements for 4 days before Day 1 and until after completion of this study.
* Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug and until after study completion.

Exclusion Criteria:

* Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption, distribution, metabolism, or excretion.
* Subject has had a previous allergy or intolerance to treatment with pitavastatin, diltiazem, or any drugs in these classes.
* Subject has a history of drug or alcohol abuse.
* Subject has had a clinically significant illness within 4 weeks before the first dose of study drug.

Primary outcomes:
measure: NK-104 AUC
timeFrame: 15 Days
Secondary outcomes:
measure: Number of Participants With at Least One Adverse Event.
timeFrame: 24 Days
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Kowa Research Institute, Inc.
name: Roger Morgan, MD, FACS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04135482: CD Patients Immune Status Evaluation
Official title: Evaluating the Immune Status of Patients With Severe Crohn's Disease Using Single Cell Sequencing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Crohn's Diease
Keywords: singcel cell sequencing
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients were diagnosed as severe CD based on clinical, laboratory, endoscopic changes and imging.

Brief summary: Using single cell sequencing method to evaluate and compare the immune status of patients with severe CD.


Eligibility criteria: Inclusion Criteria: 1, Patients with severe CD（CDAI\>16,SES-CD\>19） 2, Patients have no previous any drug therapy targeting CD or just received treatment of 5-ASA - Exclusion Criteria: 1, patients have previous treatment of prednisone, immunosuppressive agents such as azathioprine and biologic agents such as infliximab 2, patients were diagnozed as mild-moderate CD 3, patients have other immune disordered diseases such as SLE, PBC, AIH, PSC, sjogren syndrome, ulcerative colitis, and so on.

-

Primary outcomes:
measure: single cell analysis of the colonic tissue of patients with severe crohn's disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: The First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhe Jiang
Study officials:
References:
Clinical trial NCT04217382: Pre Transplantation Melanoma
Official title: Pre Transplantation Melanoma : Retrospective and Prospective Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Melanoma
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with an antecedent of melanoma before transplantation

Brief summary: Melanoma incidence is increase in global population and number of transplantation also. However immunosuppressor increase recurrence risk of melanoma.

There are more and more cases of eligible patients to transplant with an antecedent of melanoma. There is no guideline yet.

Main objective is survival time without melanoma recurrence in this population to do guideline of time limit or not between melanoma and transplantation by stage.


Eligibility criteria: Inclusion Criteria:

* patient with an antecedent of melanoma before transplantation
* Not opposite to participate

Exclusion Criteria:

* Under the age of 18
* patient under Guardianship
* patient not affiliated with a health system

Primary outcomes:
measure: survival time without melanoma recurrence
timeFrame: at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: service de dermatologie - hopital Edouard Herriot
state: Rhone
Study officials:
affiliation: Service de Dermatologie, Hôpital Edouard Herriot, Lyon
name: Emilie DUCROUX, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04274582: The Influences of Chokeberry Extract Supplementation on Handball Players
Official title: The Influences of Chokeberry Extract Supplementation on Redox Status and Body Composition in Handball Players During Competition Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Handball Players
Keywords: oxidative stress
handball players
lipid profile
aronia
body composition
Lead sponsor: University of Kragujevac
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 16
Sex: MALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study included 16 handball players, aged 16-24 years , of handball club "Novi Beograd". All study participants were apparently healthy, had no active sports injuries, did not use any medications, and were non-smokers. Standardized questionnaires conducted under the supervision of a trained nutritionist were used to collect general data, nutritional habits and use of dietary supplements. The athletes who used any dietary supplements at least a month before the study, were excluded. All participants (or their parents if they were under the age of 18) signed an informed consent document. The study was approved by the Ethical committee of The Military Medical Academy, Belgrade.

The study was conducted during regular competition season, and lasted for twelve weeks. All participants had the same training and nutritional regime, which excluded intake of berries. The players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks. For the preparation of chokeberry extract (liquid form) was used fruit (berries) of Aronia melanocarpa Elliot, Rosaceae. The extract was donated by Pharmanova Belgrade, Serbia. Process of extraction is performed under specific conditions which are subject of technical patent (producer EUHEM), for the purpose of production of extract with high concentration of polyphenols. The design of the product included few demands: sufficient daily dose of polyphenols to be dietary supplement, small volume which can be consumed as shot and acceptable taste for most consumers. Compliance was monitored by the trainers.


Eligibility criteria: Inclusion Criteria:

* healthy handball players of handball club "Novi Beograd" during competition phase.

Exclusion Criteria:

* active sports injuries,
* usage of any medications,
* smokers

Primary outcomes:
measure: Superoxide anion radical
timeFrame: three months
measure: hydrogen peroxide
timeFrame: three months
measure: nitrites
timeFrame: three months
measure: index of lipid peroxidation
timeFrame: three months
Secondary outcomes:
measure: Superoxide dismutase
timeFrame: three months
measure: Reduced glutathione
timeFrame: three months
measure: Catalase
timeFrame: three months
Other outcomes:
Locations:
city: Kragujevac
country: Serbia
facility: Faculty of Medical Science
Study officials:
References:
Clinical trial NCT06420882: Comparison of Different Treatment Methods in Patella Chondromalacia
Official title: Comparison of Different Treatment Methods in Patella Chondromalacia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chondromalacia patella (CMP) is a common condition in patients presenting to healthcare units with anterior knee pain (1).

Detailed description: Patellofemoral pain syndrome (PFPS) is the most common type of pain in runners with a prevalence of 17%; it is limited to the anterior knee or the area behind the patella between the edges of the patella. Although PFPS and CMP are often considered to be the same disease, there is still controversy about the subject. It is caused by decreased quadriceps muscle strength, change in mechanical loading, lower limb kinematics and differentiation in muscle activation patterns during running .

Eligibility criteria: Inclusion criteria:

* 18-65 years of age.
* Being diagnosed with chondromalacia
* Participate in the work on a voluntary basis
* Obtaining informed consent from them

Exclusion criteria:

* Fracture, ligament or muscle tear in the lower extremity within the last 3 months.
* Having a systemic disease
* Having a serious injury in the last 3 months

Primary outcomes:
measure: WOMAC
timeFrame: 3 weeks
measure: Stair climbing test
timeFrame: 3 weeks
measure: Range of motion of the joint
timeFrame: 3 weeks
measure: Star balance test
timeFrame: 3 weeks
measure: Horizontal jump test
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gamze Demircioğlu
state: None Selected
Study officials:
References:
Clinical trial NCT01148082: School Response to Families Who Have Children With Cancer
Official title: School Response to Families Who Have Children With Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Carcinomas
Squamous Cell Carcinoma
Adenocarcinoma
Keywords: Carcinomas (including Squamous Cell and Adenocarcinoma)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective participants will be parents/caregivers who have had school-age children treated for cancer within the last 5 years

Brief summary: The purpose of this research is to investigate school response to families who have children with cancer. It is anticipated that the results of this study will enhance the support that schools can give to the population of families who have a child with cancer. The study will involve the parents in these families, the principal and an educator in the school of the child with cancer. Measurement tools will include surveys, interviews, and other relevant educational and medical documents.


Eligibility criteria: Inclusion Criteria:

* Patients will not be recruited. Only parents, the school principals and the teachers will be recruited.
* Subjects will be 15 sets of parents who have had school-age children treated for cancer within the last 5 years.

Primary outcomes:
measure: Evidence of support
timeFrame: one time
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Michael Link
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05120882: Epidemiology of Lupus Nephritis in Nephrology Unit in Assiut University Hospital
Official title: Epidemiology of Lupus Nephritis in Nephrology Unit in Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lupus Nephritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to nephrology unit or visiting the outpatient nephrology clinic, previously or newly diagnosed with lupus nephritis in Internal Medicine Department in assiut University hospital will be recruited from December 2021 till May 2022.

Brief summary: study epidemiology of lupus nephritis patients admitted to nephrology unit inward or in outpatient clinic in Assiut Nephrology Unit

Detailed description: this study are:

To describe socio-demographic characteristics of lupus nephritis patients in Nephrology Unit of Assiut University hospital ( Old and New cases).

To determine the associated risk factors in the study population

To describe the clinical, laboratory characteristics, treatment modalities of lupus nephritis patients in Nephrology Unit of Assiut University hospital ( Old and New cases)

To Identify outcomes of treatment of these cases within 2 years according to different classes

To evaluate the effectiveness of (type of interventions mentioned) among those patients.

Eligibility criteria: Inclusion Criteria:

* all patients admitted to nephrology unit or visiting the outpatient nephrology clinic,previously or newly diagnosed with lupus nephritis.

Exclusion Criteria:

* incomplete Criteria for diagnosis of systemic lupus or presence of associated renal disease.

Primary outcomes:
measure: Study of epidemiology of lupus nephritis patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04195282: RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of HBV Related ACLF
Official title: Therapeutic Effects and Safety of RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of Hepatitis b Virus Related Acute-on-chronic Liver Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis B
Acute-On-Chronic Liver Failure
Keywords: hepatitis b virus
acute-on-chronic liver failure
artificial liver
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 20
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: This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with Hepatitis b virus 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. But there still lacks of effective therapies in treatment of HBV related ACLF, except liver transplantation. RL-1 Novel Human-derived Bio-artificial Liver treatment may be an effective and safe therapy due to the previous clinical data. This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with HBV related ACLF.

Eligibility criteria: Inclusion Criteria:

1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
2. Age from 18 to 65 years old;
3. Serum total bilirubin level \> 10 times upper limit of normal;
4. Prothrombin time activity \< 40% and ≥30%；
5. Platelets \> 50\*10 E9/L.

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. Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
8. Patients can not follow-up;
9. Investigator considering inappropriate.

Primary outcomes:
measure: Adverse events
timeFrame: 4 week
Secondary outcomes:
measure: Survival rate
timeFrame: 4 week
measure: Symptoms
timeFrame: 4 week
measure: Blood cells
timeFrame: 4 week
measure: Alanine transaminase
timeFrame: 4 week
measure: Total bilirubin
timeFrame: 4 week
measure: Serum creatinine
timeFrame: 4 week
measure: Prothrombin time
timeFrame: 4 week
measure: Blood ammonia
timeFrame: 4 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 NCT02084082: Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects
Official title: Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release (5 mg/1000 mg) Compared With the Free Combination of Linagliptin and Metformin Extended Release Tablets in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2014-03-11
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release, both under fed and fasted conditions.


Eligibility criteria: Inclusion criteria:

- Healthy male or female subjects

Exclusion criteria:

- Any relevant deviation from healthy condition

Primary outcomes:
measure: Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
measure: Maximum Measured Concentration of Linagliptin in Plasma (Cmax)
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
measure: Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
measure: Cmax of Metformin in Plasma
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
Secondary outcomes:
measure: Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
measure: AUC0-inf of Metformin in Plasma
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1288.9.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: