louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04848103: Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair
Official title: Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Pain, Postoperative
Tissue Adhesion
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Although radial extracorporeal shock wave therapy (rESWT) has proven to be an effective treatment, the effectiveness of the treatment has so far been controversial. There are no studies using rESWT in rehabilitation after arthroscopic rotator cuff repair (ARCR). Therefore, in this study, there is evidence that rESWT promotes pain control and healing recovery, and through previous studies, we would like to investigate whether treatment with rESWT during the intensive rehabilitation period of patients after ARCR is more effective in controlling pain.


Eligibility criteria: Inclusion Criteria:

* Adults over 18 years old
* In case of 6 weeks after receiving arthroscopic rotator cuff repair
* When the participants wishes to enroll in the study

Exclusion Criteria:

* 65 years old or older
* If the tear area is large and augmentation is performed
* If there is a previous surgical history at the surgical site
* Osteoarthritis in the shoulder joint

Primary outcomes:
measure: . Pain intensity
timeFrame: Change from baseline pain intensity at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: The Better Hospital
Study officials:
affiliation: Principal Investigator
name: Hyun-Joong Kim, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HJ, Choi W, Jung J, Park S, Joo Y, Lee S, Lee S. Efficacy of radial extracorporeal shockwave therapy in rehabilitation following arthroscopic rotator cuff repair: A STROBE compliant study. Medicine (Baltimore). 2022 Sep 2;101(35):e30053. doi: 10.1097/MD.0000000000030053.
Clinical trial NCT00507403: Infliximab and Methotrexate in Ankylosing Spondylitis
Official title: Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2007-07-26
Enrollment: 30
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: DIAGNOSTIC

Brief summary: There is a great individual variability of pharmacokinetic of infliximab in patients treated for ankylosing spondylitis (AS). Moreover, some patients have a treatment with methotrexate (MTX), others have not.

Thus, the aim of this study is to assess the effect of MTX on the pharmacokinetic properties of infliximab in 30 patients treated for AS, 15 with MTX, 15 without.


Eligibility criteria: Inclusion Criteria:

* Ankylosing spondylitis
* Needing anti-TNF drugs

Exclusion Criteria:

* Contra-indications to anti-TNF drugs

Primary outcomes:
measure: Pharmacokinetic properties of infliximab in AS patients with or without methotrexate
timeFrame: 16 weeks
Secondary outcomes:
measure: Individual pharmacokinetic modelisation of infliximab
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Besancon
country: France
facility: University Hospital Jean MINJOZ -Besançon
city: Tours
country: France
facility: University hospital of Tours
Study officials:
affiliation: University hospital of Tours, France
name: PHILIPPE GOUPILLE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mulleman D, Lauferon F, Wendling D, Ternant D, Ducourau E, Paintaud G, Goupille P. Infliximab in ankylosing spondylitis: alone or in combination with methotrexate? A pharmacokinetic comparative study. Arthritis Res Ther. 2011 Jun 3;13(3):R82. doi: 10.1186/ar3350.
Clinical trial NCT00890903: Non-Interventional Study With Vinorelbine ORAL in Advanced Non-Small Cell Lung Carcinoma(NSCLC) and Metastatic Breast Cancer (MBC)
Official title: Usage of Vinorelbin ORAL (Navelbine® ORAL) in the Treatment of Advanced Non-small Cell Lung Cancer(NSCLC)and Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Carcinoma
Metastatic Breast Cancer
Keywords: NSCLC
non small cell lung carcinoma
metastatic breast cancer
MBC
advanced breast cancer
Navelbine
Navelbine-ORAL
Vinorelbine
Vinorelbine-ORAL
daily routine
concomitant antiemetic therapy
patient compliance
germany
non-interventional study
oral anti cancer therapy
quality of life
Lead sponsor: Pierre Fabre Pharma GmbH
Sponsor class: INDUSTRY
Collaborators: name: iOMEDICO AG
First posted: 2009-04-30
Enrollment: 62
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: Patients with advanced non-small cell lung cancer (NSCLC) or metastatic, Antracycline-resistant breast cancer, treated with Navelbine capsules

Brief summary: The purpose of this non-interventional study is to collect data on efficacy and toxicity of the use of Navelbine ORAL in daily routine in Germany (especially after availability of an 80mg capsule). The study focusses on concomitant antiemetic therapy and patient compliance.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Male and female patients
* Advanced NSCLC (Stage III or IV) or Antracycline-resistant MBC
* Therapy with Navelbine capsules in any palliative treatment line
* Signed patient informed consent

Exclusion Criteria:

* Pregnancy and nursing
* All other exclusion criteria listed in SPC (summary of product characteristics)
* lack of signed Patient informed consent

Primary outcomes:
measure: Progression-free-survival
timeFrame: 1 year after LPI
Secondary outcomes:
measure: Time to progression
timeFrame: 1 year after LPI
measure: Adverse reactions
timeFrame: 1 year after LPI
measure: Concomitant antiemetic therapy
timeFrame: 1 year after LPI
measure: Patient compliance
timeFrame: 1 year after LPI
measure: Recording of combinations of applied capsules (requested by a patients' questionnaire)
timeFrame: 1 year after LPI
measure: General condition of patients (requested by a patients' questionnaire)
timeFrame: 1 year after LPI
measure: Therapy performance in the daily routine
timeFrame: 1 year after LPI
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Pierre Fabre Pharma GmbH
Study officials:
References:
Clinical trial NCT03918603: Decrease of Lesions Induced by Mechanical Ventilation During ARDS
Official title: Reduction of Mechanical Ventilation-induced Lesions During ARDS With Multimodal Ultra-protective Ventilation in Combination With ECMO
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ARDS, Human
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Modification of mechanically ventilated lesions by an ultra-protective multimodal strategy compared to a protective strategy in patients with veno-venous ECMO for severe ARDS.

Detailed description: the hypothesis is that ECMO, in addition to improving gas exchange, should limit the deleterious effects of mechanical ventilation (mechanical ventilation-induced lesions, VILI) by drastically reducing minute ventilation (volume reduction). current, Vt, reduction of respiratory rate, reduction of mechanical power, reduction of motor pressure or driving pressure), adapting the level of PEEP from the data collected by monitoring oesophageal pressure and systematically performing positioning sessions in the prone position. This ultra-protective strategy could thus promote the restoration of the integrity of the alveolo-capillary membrane and thus facilitate the healing of patients. In order to verify this concept and, if necessary, to propose a study whose objectives would be more clinical (mortality, ventilator-free days), we propose to carry out a study aimed at showing that this ultra-protective multimodal strategy reduces the lesions induced by mechanical ventilation compared to usual protective ventilatory management during the ECMO as proposed in the EOLIA study.

Eligibility criteria: Inclusion Criteria:

* severe ARDS with a PaO2 / FiO2 ratio ≤ 70 mmHg (for at least 2h) measured at PEEP\> 10 cmH2O and FiO2 = 1
* OR a severe ARDS with a PaO2 / FiO2\> 70 ratio but \<100 mmHg with a plateau pressure\> 35 cmH2O and a pH \<7.20

Exclusion Criteria:

* Patients with associated hemodynamic failure requiring veno-arterial ECMO
* Impossibility of setting up or contraindication to the placement of an esophageal tube
* Impossibility of realization of ventral decubitus
* Patient to receive corticosteroids during the first 48 hours following venous venous ECMO.
* Patients assisted by veno-venous ECMO for more than 24 hours.

Primary outcomes:
measure: inflammation of biotrauma
timeFrame: 36months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Emilie GARRIDO
role: STUDY_DIRECTOR
References:
Clinical trial NCT06065943: Ultrasound-guided In-plane Puncture of the Femoral Artery
Official title: Department of Cardiology Wuerzburg University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vessel Puncture Site Bleeding
Keywords: ultrasound guided puncture
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 286
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In Germany almost 1 million cardiac catheterizations are performed each year. These procedures can be done either by a transradial or a transfemoral approach. Today, the transradial approach is the recommended default strategy. Nevertheless, transfemoral access ist still frequently used. The main draw-back of a transfemoral approach are potential access site complications, which can sometimes be life-threatening. To reduce vascular complications ultrasound guided vessel puncture may be helpful.

In the "Ultrasound guided puncture of the femoral artery"-Study (US-Parfem) an optimized method of ultrasound guided femoral puncture will be evaluated. In this randomized study the new puncture technique combining ultrasound and fluoroscopy will be compared with the conventional method guided by vessel palpation and fluoroscopy. Primary endpoint of the study is the rate of primary successful puncture of the femoral common artery above the bifurcation and below the inguinal ligament ("first success rate").


Eligibility criteria: Inclusion Criteria:

* transfemoral catheterization

Exclusion Criteria:

* acute myocardial infarction

Primary outcomes:
measure: Initial successful puncture of the common femoral artery
timeFrame: 1 week
Secondary outcomes:
measure: Unsuccessful puncture attempts
timeFrame: access-phase of the procedure
measure: Perception of pain
timeFrame: Evaluated at the end of the access-phase of the procedure
measure: accidental venipuncture
timeFrame: at the end of the access-phase of the procedure
measure: Duration until successful puncture
timeFrame: Evaluated at the end of the access-phase of the procedure
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: University Hospital
Study officials:
References:
Clinical trial NCT04505943: Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion
Official title: Comparison of Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion in Nulliparous Women : a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IUCD Complication
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: PREVENTION

Brief summary: To compare the effect of vaginal dinoprostone versus vaginal misoprostol and Isonicotinic Acid Hydrazide administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous women.

Detailed description: Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility criteria: Inclusion Criteria:

* nulliparous women requesting copper IUD insertion

Exclusion Criteria:

* pregnancy,
* Parous women,
* contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion,
* untreated active cervicitis or vaginitis,
* undiagnosed abnormal uterine bleeding

Primary outcomes:
measure: The difference in visual analog scale pain scores during intrauterine device insertion
timeFrame: 10 minuts
Secondary outcomes:
measure: the difference in visual analog scale pain scores during tenaculum application
timeFrame: 10 minuts
measure: the ease of IUD insertion
timeFrame: 10 minutes
measure: women's satisfaction level: score
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT01101243: Maintenance of Vitamin D Level by UVB Radiation
Official title: How Much UVB Radiation is Necessary to Maintain Summer Vitamin D Level During Winter?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Status
Keywords: Vitamin D
UVB
Frequency
Body surface area
Dose-Response
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
First posted: 2010-04-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine the frequency of UVB radiations necessary to maintain the Vitamin D level during winter time.

Detailed description: The work is addressing vitamin D production after UVB exposure and explore how much UVB radiation which is necessary to maintain a sufficient vitamin D level during the winter period in Denmark. 4 different UVB exposure times and 2 different UVB doses to 2 different body surface areas.

Eligibility criteria: Inclusion Criteria:

* 18-65 years
* Healthy

Exclusion Criteria:

* Sun bed use
* Holiday or business travel south of 45 degrees latitude during trial
* Illness
* Drug addiction
* Pregnancy
* Lactating

Primary outcomes:
measure: Vitamin D (nmol/l)
timeFrame: Monthly during 4 months
Secondary outcomes:
measure: Parathyroideahormone (pmol/l)
timeFrame: 4 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: NV
Study officials:
affiliation: Bispebjerg Hospital, Department of Dermatology
name: Hans Christian Wulf, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00546143: Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma
Official title: Multi-center, Open-label, Multiple Dose Study in Mild to Moderate Asthmatics (With IgE/Body Weight Combinations Above That in the SmPC Dosing Table) to Determine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Omalizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma, anti-immunoglobulin E, omalizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-10-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma


Eligibility criteria: Inclusion Criteria:

* Diagnosis of allergic asthma \>= 1 year duration and a history consistent with Step 2 or 3 clinical features from the Global Initiative for Asthma guidelines.
* Eligible baseline serum immunoglobulin E (IgE) levels value and body-weight combinations

Exclusion Criteria:

* Documented medical history of anaphylaxis
* Lung disease other than mild to moderate allergic asthma such as chronic obstructive pulmonary disease (COPD)

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Safety and tolerability of omalizumab assessed by AEs and SAEs
Secondary outcomes:
measure: - Pharmacokinetic/pharmacodynamic profile of multiple administrations of omalizumab to patients with mild to moderate allergic asthma - Pre-dose specific IgE levels
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative site
city: Hannover
country: Germany
facility: Novartis investigative site
city: Mainz
country: Germany
facility: Novartis investigative site
city: Bloemfontein
country: South Africa
facility: Novartis Investigative site
Study officials:
affiliation: Novartis investigative site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kornmann O, Watz H, Fuhr R, Krug N, Erpenbeck VJ, Kaiser G. Omalizumab in patients with allergic (IgE-mediated) asthma and IgE/bodyweight combinations above those in the initially approved dosing table. Pulm Pharmacol Ther. 2014 Aug;28(2):149-53. doi: 10.1016/j.pupt.2014.03.003. Epub 2014 Mar 18.
Clinical trial NCT04598243: Treatment of Fibromyalgia and CFS With Ribose, Ashwagandha, Rhodiola, Licorice, Schisandra and Green Tea Extract
Official title: Treatment of Fibromyalgia and CFS With Ribose, Ashwagandha, Rhodiola, Licorice, Schisandra and Green Tea Extract
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Fibromyalgia
CFS
Lead sponsor: Practitioners Alliance Network
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Is a combination of Ribose, Ashwagandha, Rhodiola, Schisandra, licorice, and green tea extract helpful in CFS and FIbromyalgia?

Detailed description: Ribose has been shown to be very helpful in CFS and fibromyalgia. Many studies have also shown benefit for the symptoms of these conditions from Ashwagandha, Rhodiola, Schisandra, licorice, and green tea extract. The study is undertaken as an early open label study to check for the efficacy of a proprietary combination of these

Eligibility criteria: Inclusion Criteria:

1. be diagnosed with CFS and/or fibromyalgia
2. live in the United States 3 - be over 18 years of age

Exclusion Criteria:

1. pregnancy
2. Diabetes
3. Hypertension

Primary outcomes:
measure: VAS
timeFrame: 4-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kailua
country: United States
facility: Kona Research Center
state: Hawaii
Study officials:
References:
Clinical trial NCT00851643: Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
Official title: A Randomized, Double-Blind, Multicenter, Biphasic, Controlled With GARDASIL™ Dose-Escalation Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and ISCOMATRIX™ (IMX)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Papilloma Virus
Cervical Cancer
Vulvar Cancer
Vaginal Cancer
Genital Warts
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-02-26
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.

Detailed description: The study was performed in 2 staggered phases, Phase A and Phase B. In Phase A, participants were randomized to qHPV, Octavalent HPV with 15 mcg IMX/AAHS, or Octavalent HPV with 30 mcg IMX/AAHS. After the safety for Phase A was reviewed, Phase B was initiated. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.

Eligibility criteria: Inclusion Criteria:

* Participant is in good physical health
* Participant has had a lifetime history of 0 to 4 sexual partners
* Females between 18-to-24 years

Exclusion Criteria:

* Participant has a history of abnormal Pap test
* Participant has a history of positive test for HPV
* Participant has a history of recent or ongoing alcohol or drug abuse
* Participant is immunocompromised or has an autoimmune condition
* Participant has received immunosuppressive therapy within a year of screening
* Participant has previously received an HPV vaccine
* Participant is pregnant
* Participant has a history of external genital/vaginal warts
* Participant is currently enrolled in a clinical trial
* Participant has a history of a severe allergic reaction that required medical attention

Primary outcomes:
measure: Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
timeFrame: 4 weeks postdose 3 (Phase A)
measure: Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
timeFrame: 4 weeks postdose 3 (Phase B)
measure: Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
timeFrame: 4 weeks postdose 3 (Phase A)
measure: Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
timeFrame: 4 weeks postdose 3 (Phase B)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: