louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00926809: H. Pylori Eradication on Healing of Iatrogenic Gastric Ulcer by Endoscopic Mucosal Resection
Official title: Helicobacter Pylori Eradication Therapy on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection of Gastric Neoplastic Lesions: a Multicenter, Randomized, Double Blind, and Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ulcer
Keywords: endoscopic mucosal resection
iatrogenic
Lead sponsor: Korean College of Helicobacter and Upper Gastrointestinal Research
Sponsor class: OTHER
First posted: 2009-06-24
Enrollment: 232
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of Helicobacter pylori eradication therapy on the healing of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic lesions and is a multicenter, randomized, double blind, and placebo controlled trial.


Eligibility criteria: Inclusion Criteria:

* 30 - 75 years old
* Early gastric cancer (\< 3 cm in size, mucosa confined, differentiated type) or gastric adenoma (\< 3 cm in size)
* Helicobacter pylori positive

Exclusion Criteria:

* Medication of anti-secretory drugs (proton pump inhibitors, H2-receptor antagonists, antacid, bismuth compound)
* History of Helicobacter pylori eradication
* History of gastric surgery or other cancers
* Major comorbidities
* Medication of ASA, NSAIDS, steroids, anti-coagulants

Primary outcomes:
measure: ulcer healing rate by endoscopic assessment
timeFrame: 8 weeks
Secondary outcomes:
measure: ulcer reduction rate by endoscopic assessment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center Korea
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
affiliation: Korean College of Helicobacter and Upper Gastrointestinal Research
name: Hyun Chae Jung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05075109: TENS and Spasticity in Stroke Patients
Official title: Effects of Transcutaneous Electrical Nerve Stimulation on Upper Limb Spasticity, Strength and Functional Status in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Spasticity
Upper limb
TENS
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: study aims to evaluate the efficacy of high and low frequency TENS on spasticity, strength and functional status in stroke patients. It may provide further knowledge concerning the use of TENS for motor impairments in stroke patients and may clarify ambiguities to some extent.

Detailed description: Despite the positive effects of electrical stimulation proved on motor impairments of affected limb, the evidence is still not conclusive. There still remains a question mark regarding the effectiveness and optimal stimulation parameters of TENS. there has been conflict regarding the TENS parameters (frequency, duration, intensity) among different studies. To date TENS parameters used in different studies to reduce spasticity range from frequency of 1.7-100 Hz, duration from 15-60 minutes and sessions from 1-30. The use of different parameters may account for the contradictory results related to effectiveness of TENS.

Eligibility criteria: Inclusion Criteria:

* Both male and female aged 40-70 years
* Middle cerebral artery (MCA) stroke
* 6 months after stroke
* Mini-mental state examination (MMSE)more than 24
* Modified Ashworth scale score between1 and 2

Exclusion Criteria:

* Patients with multiple sclerosis, spinal cord injury or with other pre-existing neurological disorders.
* Patients with orthopedic condition affecting upper extremity
* Patients with contraindication to TENS, like skin damaged etc.

Primary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Manual Muscle Testing (MMT)
timeFrame: 8 weeks
measure: Action Research Arm Test (ARAT)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Larkana
country: Pakistan
facility: Chandka Medical College Hospital
state: Sindh
Study officials:
affiliation: Riphah International University
name: Mirza Obaid Baig, MSPT(NMR)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01878409: Study of Sexuality in Parkinson Disease
Official title: Study of Sexuality in Parkinson Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Sexuality
Parkinson Disease
BISF
IIEF
FSFI
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 244
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed as having idiopathic PD were recruited from four Italian Movement Disorders Clinics

Brief summary: The aim of this study is to evaluate the different aspects of sexual function among adults with Parkinson Disease to develop a treatment and address sexual problems as a routine part of diagnostic workup and therapeutic planning.

Detailed description: Because there is limited literature on sexual function in Parkinson disease, in this study, we examined sexual functioning in a large groups of patients with idiopathic Parkinson Disease compared with healthy subjects in the Italian community. To assess sexual function in PD we used the Brief Index of Sexual Functioning \[(BISF-M for man; BISF-W for woman), the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI). Participants were also assessed by the Beck Depression Inventory (BDI).

This study aimed to provide a thorough epidemiological description of sexual dysfunction in Parkinson's disease. The knowledge of sexual function in PD might help to plan effective interventionist measures and ultimately to optimize patient's and the partner's quality of life.

Parkinson patients (aged 40-80) and 123 healthy controls (aged 40-80) will be recruited from four Italian Movement Disorders Clinics.

Eligibility criteria: Inclusion Criteria:

* idiopathic PD
* marital status
* age 40-80

Exclusion Criteria:

* patients taking PDE

Primary outcomes:
measure: BISF
timeFrame: Baseline
Secondary outcomes:
measure: BDI
timeFrame: Baseline
measure: PDQ8
timeFrame: Baseline
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Università di Milano
name: Alberto Priori, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02182609: 99mTc-rhAnnexin V-128: a First In Man Study in Healthy Volunteers
Official title: A Phase I Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 Administered Intravenously in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Volunteers
Lead sponsor: Advanced Accelerator Applications
Sponsor class: INDUSTRY
Collaborators: name: Atreus Pharmaceuticals Corporation
First posted: 2014-07-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objectives of this study are:

* To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128 administered as an intravenous bolus over 10-20 seconds.
* To determine the biodistribution, pharmacokinetics and radiation dosimetry of 99mTc-rhAnnexin V-128 in normal healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 65 years
2. No significant medical history
3. Normal physical examination
4. No clinically significant abnormalities in baseline laboratory values
5. No clinically significant abnormalities on 12 lead electrocardiogram
6. Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening and pre-injection on dosing day
7. Written informed consent signed

Exclusion Criteria:

1. Pregnancy or lactation
2. Know hypersensitivity to the investigational drug or any of its components
3. Current enrolment in another investigational study
4. Unwillingness to provide or continue informed consent

Primary outcomes:
measure: Adverse events
timeFrame: Whole study period
measure: Laboratory assessments
timeFrame: baseline and 24 hrs, 72 hrs and 30 days after injection
measure: Electrocardiography
timeFrame: screening and immediatly, 24hrs, 72 hrs, 7 days and 30 days after injection
measure: Vital signs
timeFrame: At each study visit
Secondary outcomes:
measure: rhAnnexin V-128 serum concentration
timeFrame: 0, 5, 10, 15, 30, 60, 90, minutes and 3 h, 6h and 24 h post-injection
measure: Whole-body SPECT imaging
timeFrame: 30min, 90min, 3hrs, 6hrs and 24 hours post-injection
measure: Blood sample counting
timeFrame: baseline and 0, 5,10, 15, 30, 60, 90 min, 3 h, 6 h and 24 hours post-injection
measure: Amount of 99mTc excreted in urine
timeFrame: One sample at baseline and urine collection within 24 hours post-injection
measure: Amount of 99mTc excreted in faeces
timeFrame: Baseline and within 24h post injection
measure: Anti-rhAnnexin V-128 IgG and IgM antibodies
timeFrame: Baseline and 14 and 30 days post-injection
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: The University of Ottawa Heart Institute, The Ottawa Hospital
name: Terrence D. Rudy, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01059409: Study of Meniscal Allografts
Official title: The Clinical and Medico-economical Evaluation of Meniscal Allografts in the Sequelae of Total or Sub-total Meniscectomy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Meniscectomy Sequelae
Keywords: Meniscal Allografts
Osteoarthritis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2010-01-29
Enrollment: 23
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: Total or subtotal meniscectomies in young patients are currently responsible of pain and limitation of activities. There isn't any other treatment than meniscal replacement. But there is no randomized clinical trial on meniscal allograft to validate the efficiency of this treatment.

Detailed description: Meniscal allograft is done through United States and Europe since the last fifteen years. Operative technique has regularly improved, especially because of new arthroscopic devices. The meniscal allografts to be used are taken from dead donors and then frozen according to all the reglementary aspects of tissue bank.

The graft has to be ordered as soon as the patient is randomized ; the sizing of the graft ordered is important depending on the gender size and height of the patient and on the measures of the tibial plateau on X Rays.

The arthroscopic procedure is done under general or loco-regional anesthesia. The graft has to be prepared with bone blocks attached to the anterior and posterior horn of the meniscal graft. These bone blocks will be fixed through bone tunnels and the meniscus itself will be sutured on the peripheral meniscus synovial rim.

Eligibility criteria: Inclusion Criteria:

* Age from 18 on
* Previous total or subtotal meniscectomy
* Medical insurance
* Female patients have to be under contraceptive treatment
* Sign consent form

Exclusion Criteria:

* Age \< 18 years
* Pregnant or breast-feeding woman
* Need of a simultaneous frontal osteotomy
* Inflammatory disease
* Septic background
* Psychiatric background
* Understanding difficulties or problems for follow-up
* No consent
* No medical insurance

Primary outcomes:
measure: "Function" Subscale in the Koos Scale (area under the curve)
timeFrame: 2 years follow up
Secondary outcomes:
measure: Clinical criteria: pain, quality of life, professional activity
timeFrame: At 2 years follow-up
measure: Post operative and late complications
timeFrame: At 2 years follow-up
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne - Service de Chirurgie orthopédique
state: Ile De France
city: Toulouse
country: France
facility: POTEL Jean-François, Clinique Medipole Garonne
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Patricia THOREUX, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02898909: Comparison of Two Fragmentation Modalities in Femtosecond Laser-assisted Cataract Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cataract
Keywords: femtosecond laser-assisted cataract surgery
nuclear lens fragmentation
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed by ultrasound phacoemulsification of nuclear lens, which is then removed.

It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of ultrasonic energy.

The decrease of ultrasonic energy delivered during cataract surgery is beneficial to the patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal transparency.


Eligibility criteria: Inclusion Criteria:

* patient aged ≥ 18 years old
* first Femtosecond Laser-assisted Cataract Surgery scheduled
* cataract density ≥ 3 according to the lens opacities classification system (LOCS)

Exclusion Criteria:

* corneal guttata, uncontrolled glaucoma
* shallow depth of anterior chamber
* patient's refusal to participate in the study
* pregnant or breast feeding patient
* patient under legal protection
* no health coverage

Primary outcomes:
measure: energy delivered for lens nucleus aspiration during phacoemulsification
timeFrame: approximatively 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Opthalmologique A de Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Jean-Luc FEBBRARO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05617209: In Vitro Correction of Thrombin Generation by Concizumab (Anti-TFPI) for Severe Hemophilia Patients
Official title: Tissue Factor Pathway Inhibitor (TFPI) and Haemorrhagic Manifestations in Haemophilia A and B Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia
Keywords: anti-TFPI antibody
thrombin generation
tissue factor concentration
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 20
Sex: MALE
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Haemophilia A and B patients

Brief summary: Studies have shown, in haemophilia patients, the effectiveness of Anti TFPI antibody (aTFPIAb) to prevent joint and muscular bleeding (tissues poor in Tissue Factor (TF)). However, cases of cerebral thrombosis (tissues rich in TF) have been observed in some patients treated with this antibody. Because an inter-individual variation in thrombin generation correction by aTFPIAb, an aTFPIAb concentration effective at low TF concentration could be at the same time thrombogenic at high TF concentration.

Detailed description: The aim of this study is to determine, for each patient, the minimum concentration of aTFPIAb necessary to restore thrombin generation in the presence of low (1pM) TF concentration and to evaluate at this concentration of aTFPIAb a potential thrombogenic effect in the presence of a high (10pM) TF concentration.

Eligibility criteria: Inclusion Criteria:

* Severe or moderate haemophilia A or B patient with FVIII or FIX \<5% with or without prophylaxis
* Affiliated or beneficiary of a social security regimen
* Signature of consent

Exclusion Criteria:

* Haemophilia patients aged 12 years or less with a weight less than 30 kg (taking into account the volume of blood collection).
* Patients who received factor VIII concentrates less than 48 hours or factor IX concentrates less than 96 hours prior to the routine blood draw at the Hemophilia Clinic. 96 hours prior to the routine blood draw at the Hemophilia Centre

Primary outcomes:
measure: minimum concentration of anti-TFPI antibody
timeFrame: day 1
Secondary outcomes:
measure: Measurement of the clot structure
timeFrame: day 1
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Brigitte Tardy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05553509: Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection with Borderline Vascularity
Official title: Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection with Borderline Vascularity: an Important Consideration of Timing of Revascularization
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Limb Threatening Ischemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: On the other hand we can consider patients as Borderline ischemia/ Boarderline Vascularity with (Rutherford Grade "I" Categories "2\&3) when they have a borderline ankle systolic pressure

Brief summary: Observe Timing to complete healing of wounds \& Limb salvage in both cohorts those who are undergoing Debridement only and those who are undergoing Debridement plus PTA

Detailed description: Secondary Aims of the study include Length of hospital stay , Necessity of further intervention(Whether a Revascularization Procedure or More Debridement sessions) , Incidence of MACE (Major Adverse Cardiovascular Events) in both groups

Eligibility criteria: Inclusion Criteria:

* Patients will be included in this study are those suffering from DFUs; and Borderline Ischemia (BLI) / Borderline Vacularity with (Rutherford Grade "I" Categories "2\&3") when they have a borderline ankle systolic pressure

Exclusion Criteria:

* All patients with (CLI) and DFUs as they are indicated for urgent re-vascularization.

Severely infected/ gangrenous wounds requiring amputation hindering possible limb salvage.

Lesions lying within or adjacent to an aneurysm; Non diabetic cases with foot ulcers; Arteritic lesions;(Vasculitic Patients). Patients had prior major amputation, bypass surgery, and endarterectomy on any vessel of the ipsilateral (target) extremity

Primary outcomes:
measure: Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity
timeFrame: 1 YEAR
Secondary outcomes:
measure: Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity
timeFrame: 1 YEAR
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Department of vascular surgery - Assiut University Hospital
Study officials:
References:
Clinical trial NCT05911607: PBMT Influence on Alveolar Socket Preservation
Official title: Influence of Photobiomodulation Therapy (PBMT) as an Adjunctive Therapy in Alveolar Socket Preservation Preceding Dental Implant Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extraction Socket Healing
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 20
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing between 2 laser' effect on extraction socket healing
Primary purpose: SUPPORTIVE_CARE

Brief summary: Goal of this study is to compare between the effect of two different low power lasers on extraction socket healing.

Detailed description: After molar tooth extraction, 6 Low power (PBMT) laser sessions.

Evaluation:

Visual Radiographic Histological

Eligibility criteria: Inclusion Criteria:

* Fit for implant rehabilitation.
* Acceptable oral hygiene.
* Willingness to attend 6 visits within 15 days of extraction.

Exclusion Criteria:

* Uncontrolled diabetes.
* Sub optimal oral hygiene.
* Heavy smoker.

Primary outcomes:
measure: Radiographic socket dimensions
timeFrame: 3 months
Secondary outcomes:
measure: Soft tissue healing
timeFrame: 15 days
measure: Histological examination
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Institut of laser enhanced sciences
Study officials:
affiliation: National Institute of Laser Enhanced Sciences, Cairo University
name: Ahmed Ab Zaky
role: STUDY_DIRECTOR
References:
citation: Rosero KAV, Sampaio RMF, Deboni MCZ, Correa L, Marques MM, Ferraz EP, da Graca Naclerio-Homem M. Photobiomodulation as an adjunctive therapy for alveolar socket preservation: a preliminary study in humans. Lasers Med Sci. 2020 Oct;35(8):1711-1720. doi: 10.1007/s10103-020-02962-y. Epub 2020 Jan 22.