louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01150929: Rehabilitation After Total Knee Arthroplasty (TKA) - PFC Rotating Versus Fixed Bearing
Official title: Rehabilitation After Total Knee Arthroplasty - Rotating Platform Versus Fixed Bearing Polyethylene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Knee arthroplasty
RSA
DXA
Gait analysis
Motion analysis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Silkeborg
name: Gigtforeningen
name: Protesekompagniet
First posted: 2010-06-25
Enrollment: 55
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether patient rehabilitation is equal for patients operated with two different knee implant designs.

The patients are randomized to treatment with either a simple hinge design implant (fixed bearing) or an implant with a mobile bearing polyethylene. This design difference might in principle enable the patients in the latter group to rehabilitate towards a more normal gait pattern.


Eligibility criteria: Inclusion Criteria:

* Patients at Silkeborg Regional Hospital, Orthopedic Dept. referred to total knee arthroplasty.

Exclusion Criteria:

* Neurologic disease with impact on gait.
* Orthopaedic disease ipsilateral hip joint.
* Patients outside the age limits.
* No informed consent signed.
* Patients suffering from dementia.
* Patients primarily included, but who perioperatively has their posterior cruciate ligament injured or sacrificed.
* Patients who later develop deep venous thrombosis or infection in the operated knee.

Primary outcomes:
measure: Radio Stereometric Analysis
timeFrame: 24 months
Secondary outcomes:
measure: Gait analysis
timeFrame: 12 months
measure: DXA
timeFrame: 24 months
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital
Study officials:
affiliation: Aarhus Sygehus THG
name: Kjeld Soballe, DMsc
role: STUDY_CHAIR
References:
Clinical trial NCT04768829: Antifungal Potential of Moringa Olifera Against Otomycosis
Official title: Antifungal Potential of Moringa Olifera-loaded Nanoparticles Against Otomycosis; Preparation, Characterization, and Clinical Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Otomycosis
Lead sponsor: Deraya University
Sponsor class: OTHER
Collaborators: name: Minia University
First posted: 2021-02-24
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: moringa extract ear drops
Primary purpose: TREATMENT

Brief summary: patients with Otomycosis were recognized by an ENT specialist. 20 patients were distributed randomly into two groups. The first group will be treated with Nystatin ear drops twice daily. The second group will be treated with Moringa ear drops. patients will be examined endoscopically by the ENT specialist. patient's swabs will be isolated and analyzed by ELISA.

Detailed description: Inclusion criteria:

(1) Otomycosis .

Exclusion criteria:

1. tympanic membrane perforation;
2. concurrent immune suppression,
3. and concurrent bacterial infection.

Eligibility criteria: Inclusion Criteria:

1. Otomycosis
2. ear inflammation

Exclusion Criteria:

1. tympanic membrane perforation
2. concurrent immune suppression,
3. concurrent bacterial infection.

Primary outcomes:
measure: Number of participants recovered with clear endoscopic examination
timeFrame: one week
measure: Identification of different microorganisms infected ear
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Soad A. Mohamad
state: المنيا
Study officials:
affiliation: Deraya University
name: Soad A Mohamad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02372929: Relationship Between Endoscopic Ultrasound Staging and Degree of Stricture in Esophageal Cancer
Official title: Relationship Between Endoscopic Ultrasound Staging and Degree of Stricture in Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred for EUS for esophageal cancer staging will be eligible for participation in this study.

Brief summary: The primary objective of this study is to document all cases of EUS in patients with esophageal cancer and determine if the inability to advance the gastroscope beyond the tumor correlates with locally advanced disease stage at Endoscopic Ultrasound.

Detailed description: This will be an observational prospective study. The investigators will aim to enroll 100 male and female adult patients (aged 19 years and over) of all ethnicities/races, who have been referred to Florida Hospital for Endoscopic Ultrasound staging of esophageal cancer. All vulnerable populations will be excluded.

The investigators will be using a standardized data collection form to record presenting symptoms, endoscopy findings, Endoscopic Ultrasound features and final esophageal cancer staging. This is an observational study in which standard of care is being practiced and also as the patients are not placed at additional risk from participating in this study. However, as the investigators are collecting data prospectively, all participants will sign consent. An attempt will be made to see if there is a correlation between stricture tightness encountered at endoscopy (EGD) with advanced disease stage diagnosed at Endoscopic Ultrasound.

Eligibility criteria: Inclusion Criteria:

1.All patients aged \> 18 yrs, who can provide informed consent and referred to Florida Hospitals Endoscopy Unit for EUS staging of esophageal cancer.

Exclusion Criteria:

1. Age \< 18 yrs
2. Inability to provide informed consent.
3. Unable to safely undergo endoscopy for any reason
4. Coagulopathy (prolongation of Prothrombin time \> 18 secs, thrombocytopenia \< 80,000 platelets/ml)
5. Limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events and follow-up phone visits cannot be provided
6. Non-English speaking without a translator.

Primary outcomes:
measure: Evaluate the relationship between tightness of esophageal stricture encountered at endoscopy with cancer staging at EUS.
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital Center for Interventional ENdoscopy
state: Florida
Study officials:
affiliation: AdventHealth
name: Shyam S Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02248129: Pharmaco-epidemiological Study Describing a Population of Hypertensive Patients Treated With a Fixed-dose Combination of Telmisartan and Hydrochlorothiazide
Official title: Pharmaco-epidemiological Study Describing a Population of Hypertensive Patients Treated in General Practice With a Fixed-dose Combination of Telmisartan and Hydrochlorothiazide, the Level of Blood Pressure Control and the Modalities of Arterial Hypertension Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 4255
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive patients treated in general practice

Brief summary: Study to compare the level of blood pressure control in hypertensive, hypertensive diabetics and hypertensive with renal insufficiency (observed data) in the study population, with the objectives of the High Authority for Health recommendations (benchmark)


Eligibility criteria: Inclusion Criteria:

* Hypertensive patients already treated for at least 1 month with Telmisartan plus hydrochlorothiazide, consulting the physician consecutively for whatever reason

Exclusion Criteria:

* NA

Primary outcomes:
measure: Percentage of patients with low blood pressure
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01670929: Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abortion, Habitual
Keywords: recurrent miscarriages
progesterone
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2012-08-22
Enrollment: 700
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice daily), started soon as possible at luteal phase and after a positive pregnancy test and continued to 28 weeks of gestation, compared to placebo, ).

Detailed description: Progesterone improves secondary outcomes such as gestation at delivery, on-going pregnancy at 12 weeks, survival at 28 days of neonatal life.

. Progesterone, compared to placebo, does not incur substantial adverse effects to the mother or the neonate.

Explore differential or subgroup effects of progesterone in prognostic subgroups.

. Perform an economic evaluation for cost-effectiveness.

Eligibility criteria: Inclusion Criteria:

1. Women with unexplained recurrent miscarriages (2 or more consecutive first trimester miscarriages).
2. Age 18-39 years at randomisation (likelihood of miscarriages due to chromosomal aberrations is higher in older women; such miscarriages are unlikely to be prevented by progesterone therapy).
3. Spontaneous conception (as confirmed by urinary pregnancy tests).
4. Willing and able to give informed consent.

Exclusion Criteria:

1. Age less than twenty or above forty years old.
2. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[IgG or IgM\]); other recognised thrombophilic conditions (testing according to usual clinic practice)
3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
4. Fibroids distorting uterine cavity.
5. Abnormal parental karyotype.
6. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).

Primary outcomes:
measure: Number of patients continued the pregnancy beyond 20 weeks gestation.
timeFrame: 2 years
Secondary outcomes:
measure: Number of miscarriages
timeFrame: 2 years
Other outcomes:
measure: Number of Live Birth
timeFrame: 2 years
measure: Number of preterm delivery
timeFrame: 2 years
Locations:
city: Assiut
country: Egypt
facility: Women's Health Hospital
Study officials:
affiliation: Faculity of medicine,Assiut university
name: Alaa M Ismail, M D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05307029: Immediate and Flapless Full-arch Rehabilitation of Edentulous Jaws
Official title: Immediate Fixed Full-arch Rehabilitation of Edentulous Jaws on 4 or 6 Implants According to the Nobelguide® Protocol: a Retrospective Study on Clinical and Radiographic Outcomes up to 10 Years of Follow-up.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edentulous Patients
Keywords: full- arch implant prosthesis
flapless implant surgery
immediate Dental Implant Loading
Surgery
Computer-Assisted
Dental Implants
template-guided surgery
all on four
all on six
; tilted implants
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this retrospective cohort study, participants were recruited from edentulous patients rehabilitated with fixed full-arch prosthesis on 4 or 6 implants according to the Nobelguide® protocol between Jun 2009 and December 2019 at the Oral Surgery Unit, Policlinico Umberto I, "Sapienza" University of Rome, Italy. No randomization was applied.

Brief summary: The study involved 28 edentulous patients (20 female/8 males; average age of 67.75± 8.627 years) rehabilitated with 33 prostheses (17 all-on-4/16 all-on-6) supported by 164 implants.

Detailed description: Clinical and radiographic outcomes were implants survival, prostheses success/survival, implant marginal bone loss, incidence of biological and prosthetic complications.

Eligibility criteria: Inclusion Criteria

* Mandibles or maxillae edentulous or with hopeless teeth;
* Patient's request of fixed implant restorations
* Patients in general good health (ASA-1/ASA-2)

Exclusion Criteria

* Compromised systemic conditions;
* Head/neck irradiation or chemotherapy within 2 years;
* Bisphosphonate therapy;
* Metabolic bone diseases;
* Insufficient bone volume;
* Mouth opening less than 50 mm inadequate to place surgical instrumentations.
* History of periodontitis or smoking habit were not considered exclusion criteria.

Primary outcomes:
measure: Implant marginal bone loss (MBL)
timeFrame: from the functional loading time with the provisional prosthesis (baseline) T0 to the end of the follow-up, assessed up to 10 years and measured in millimeters on periapical radiographs taken every year using the parallel long-cone technique.
measure: Prosthetic complications
timeFrame: Every 6 months from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up, assessed up to 10 years.
measure: Biologic complications
timeFrame: Every 6 months from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up, assessed up to 10 years.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sapienza University of Roma
name: Maria Paola Cristalli, DDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04481529: COVID-19 Serological Status of Hospital Staff Working or Not in the COVID-19 Sector
Official title: Study of the COVID-19 Serological Status of Hospital Staff Working or Not in the COVID-19 Sector in 3 French Regions Facing the COVID-19 Epidemic With Varying Degrees of Intensity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection Viral
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 1576
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital staff

Brief summary: Hospital staff, on the front line in the COVID-19 crisis, have many questions about the risk that they have been infected with this potentially fatal virus. These questions of course primarily concern caregivers working in sectors dedicated to COVID-19 patients, whether they are resuscitating or not, but also those in non-COVID-19 sectors, or even staff without direct contact with patients. In addition, depending on the suddenness and intensity of this "COVID-19 wave", these personnel have been more or less trained and sometimes exposed due to the dire lack of protective equipment. In some countries such as Great Britain, this has resulted in significant absenteeism, a source of deepening the shortage of caregivers.

This proportion of contaminated caregivers has not been evaluated on the whole of French territory. Studies from other countries suggest figures ranging from 1.5% in China to 20% in Italy. It is therefore impossible to rely on such variable data to have a reliable estimate.

Since june 2020, all staff in French health establishments could benefit a serological test.

Thus, in this epidemiological study, we propose to rely on this institutional serological screening to describe the link between seroconversion of hospital staff, regional intensity of the epidemic, and sectors of activity (COVID-19 sectors, non-COVID-19 caregivers , non-COVID-19 non-caregivers.


Eligibility criteria: Inclusion Criteria:

* Hospital staff from Argenteuil, Belfort, Dijon and Limoges hospitals.
* Age ≥ 18 years old
* Participation agreement

Exclusion Criteria:

* Protected persons
* Refusal of participation

Primary outcomes:
measure: Number of subjects with a COVID-19 seroconversion
timeFrame: through study completion, an average of 5 month
Secondary outcomes:
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: CH Argenteuil - Service de Réanimation
city: Belfort
country: France
facility: Ch Belfort
city: Dijon
country: France
facility: CHU Dijon - Serve de Réanimation
city: Limoges
country: France
facility: CHU de Limoges
Study officials:
References:
Clinical trial NCT04242329: Surgery of Melanoma Metastases After Systemic Therapy
Official title: Surgery of Melanoma Metastases After Systemic Therapy - the SUMMIST Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Melanoma
Melanoma Stage IV
Metastatic Melanoma
Surgery
Keywords: Immunotherapy
Metastatic surgery
Surgical oncology
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2020-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Phase II Randomized Controlled Open-Label Parallel Group Interventional Multicenter Trial
Primary purpose: TREATMENT

Brief summary: To evaluate if surgical removal of residual disease adds benefit in stage IV melanoma patients with partial response or stable disease after a minimum 9 months of first-line PD-1 inhibition. Primary endpoint: Disease-free survival (DFS) at 12 months.

Detailed description: A Phase II Randomized Controlled Open-Label Parallel Group Interventional Multicenter Trial. Patients with metastatic melanoma, stratified for stage M1a or M1b/M1c, that have received first-line treatment with PD-1 inhibitors for a minimum of 9 months resulting in either partial response or stable disease according to RECIST 1.1 will be eligible. Patients will be screened for operability based on CT-scans examined by a multidisciplinary team, with the criteria that complete (R0) resection of all metastases should be possible. If the multidisciplinary team find that this would be possible, patients will be included and randomized 1:1 to either surgery with continued PD1-inhibition or current standard of care with continued PD1-inhibition only. At progression, treatment will be according to the treating medical oncologist. Active follow-up will be performed for 12 months.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Signed and dated written informed consent before the start of specific protocol procedures
* Biopsy or cytology proven metastatic melanoma stage M1a, M1b or M1c
* Have received a minimum of 9 months of immunotherapy (PD1-inhibitor alone or in combination) resulting in stable disease or partial response according to RECIST 1.1
* Metastases judged to be radically resectable by surgery at a multidisciplinary conference
* ECOG performance status 0-2

Exclusion Criteria:

* Brain metastasis (M1d)
* Previous treatment with BRAF/MEK inhibitors
* Inability to understand given information or undergo study procedures according to protocol

Primary outcomes:
measure: DFS 12 months
timeFrame: 12 months
Secondary outcomes:
measure: SAE 12 months
timeFrame: 12 months
measure: Complications
timeFrame: 3 months post operatively
measure: R0 resection
timeFrame: 3 months post operatively
measure: PFS 12 months
timeFrame: 12 months
measure: MSS 12 months
timeFrame: 12 months
measure: OS 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT00097929: An Investigational Drug Study With Suberoylanilide Hydroxamic Acid in Relapsed Diffuse Large B-cell Lymphoma (0683-013)
Official title: A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: B-cell Lymphoma
Keywords: Relapsed Diffuse Large B-cell Lymphoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-12-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug in the treatment of relapsed diffuse large B-cell lymphoma.


Eligibility criteria: Inclusion Criteria:

* Patient must be 18 years or older with relapsed Diffuse Large B-cell Lymphoma (DLBCL).
* Stable disease or better for at least 3 months on most recent treatment
* Have not received any chemotherapy, radiation therapy, major surgery, or any other investigational therapy for at least 4 weeks prior to entry in this study
* Adequate blood testing, liver, and kidney function as required by the study.
* Eligible subjects will allow tissue samples to be examined and stored.

Exclusion Criteria:

* Patient has been treated with other investigational agents with a similar anti-tumor mechanism.
* Patient should not have failed more than 3 prior treatment regimens.

Primary outcomes:
measure: Objective response rate based on FDG-PET and CT scan findings.
Secondary outcomes:
measure: Response duration, Progression-free survival, Time to progression, Time to response, 3-Month and 6-month progression free survival.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Crump M, Coiffier B, Jacobsen ED, Sun L, Ricker JL, Xie H, Frankel SR, Randolph SS, Cheson BD. Phase II trial of oral vorinostat (suberoylanilide hydroxamic acid) in relapsed diffuse large-B-cell lymphoma. Ann Oncol. 2008 May;19(5):964-9. doi: 10.1093/annonc/mdn031. Epub 2008 Feb 21.