louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04611698: Immediate Loading of Bone Anchored Hearing Devices
Official title: Immediate Loading of Bone Anchored Hearing Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Northern Care Alliance NHS Foundation Trust
First posted: 2020-11-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Bone anchored hearing aids provide a hearing solution for patients that are unable to wear traditional air conduction hearing aid solutions. The technology of the devices has developed significantly over the last 510 years and patients are gaining access to their sound processor at a much earlier stage than when first brought onto the market. Despite this the investigators feel there is still room to develop this and with the new abutments with specialised hydroxyapatite coating it is hoped that patients can be loaded with their sound processor in the day of surgery. This study will compare abutment stability between two groups of patients. Those loaded immediately with their sound processor and those loaded traditionally at 2 weeks post operatively.

At routine followup appointments patients will have the stability of their abutment checked and the investigators will compare to see if loading earlier had any detrimental effects on osteointegration and the stability of the abutment.

Based on the favourable outcomes and high stability record for the BA400 it is anticipated that the time to processor fitting may be further reduced, provided favourable bone conditions at the implant site and provided satisfactory soft tissue status at the time of loading. It is hypothesised that loading immediately at the time of surgery is possible with comparable short and long term outcomes when compared to standard loading at 2 weeks


Eligibility criteria: Inclusion Criteria:

* Patients eligible for receiving the Baha system.

Exclusion Criteria:

* Adult patients, i.e. ≥18 years
* Eligible for the Baha system
* Bone thickness at the implant site of at least 4 mm
* No known disease or treatment that compromises / will compromise the bone quality at the implant site

Primary outcomes:
measure: Compare device stability and rate of successful implantation
timeFrame: 12 months
Secondary outcomes:
measure: Measure the stability, as determined by Implant Stability Quotient (ISQ) values, of Baha implants placed immediately and at 23 weeks post operatively.
timeFrame: 23 weeks
measure: Record implant survival over time.
timeFrame: 12 months
measure: Monitor the status of the periimplant soft tissue using the classification proposed by Holgers' et al.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02997098: Longitudinal Outcomes in Hepatic Resection
Official title: Longitudinal Outcomes in Hepatic Resection
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Liver Diseases
Surgery
Keywords: Hepatectomy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing liver resection for non-transplant indications.

Brief summary: This observational registry of patients undergoing liver surgery collects patients both retrospectively and prospectively. Patients undergoing liver resection for any non-transplant indication will be evaluated for clinical outcomes (such as surgical complications, survival, and disease progression) based on clinical and patient factors (like indication, age, and other treatments for the disease).


Eligibility criteria: Inclusion Criteria:

* Patients requiring liver resection

Exclusion Criteria:

* Patients under the age of 18 years
* Patients undergoing liver transplant

Primary outcomes:
measure: Overall survival
timeFrame: 10 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 10 years
measure: Surgical-site infection
timeFrame: 3 months
measure: Postoperative bleeding
timeFrame: 3 months
measure: Blood clot
timeFrame: 3 months
measure: Use of other therapy
timeFrame: 5 years
measure: Operative time
timeFrame: 1 day
measure: Intraoperative blood loss
timeFrame: 1 day
measure: Number of segments resected
timeFrame: 1 day
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: DUHS
name: Sabino Zani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06312098: Perioperative Factors and Living Donor Liver Transplantation
Official title: The Study on Perioperative Factors Affecting Postoperative Outcomes in Patients Who Underwent Adult Liver Transplantation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Transplant Disorder
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 533
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data from adult patients undergoing elective living donor liver transplantation at Seoul St. Mary's Hospital were retrospectively collected with the electronic medical record system.

Brief summary: Liver transplant surgery is one of the treatments provided to patients suffering from end-stage liver disease, and has a successful treatment prognosis. However, it is clear that patient management before, during, and after surgery is a difficult task for medical staff due to the complex clinical and pathological problems of end-stage liver disease. Moreover, the complex surgical technique of the liver transplant surgery itself and the severe hemodynamic fluctuations and multi-organ dysfunction that patients experience during the surgery have been shown to have a tremendous impact on the patient's prognosis after surgery.

A study on which clinical, laboratory, and hemodynamic factors experienced by patients during the perioperative period, including before, during, and after surgery, affect the survival rate of patients and transplanted organs. will definitely be helpful in the treatment of patients suffering from end-stage liver disease.


Eligibility criteria: Inclusion Criteria:

* adults
* elective surgery
* American Society of Anesthesiologists (ASA) physical status classification system I, II, III

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status classification system IV, V

Primary outcomes:
measure: Incidence of postreperfusion syndrome
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05161598: Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)
Official title: PRE-APPROVAL ACCESS (PAA) Single Patient Request (SPR) TREATMENT GUIDELINES for Teclistamab (JNJ-64007957) for Treating Physician Use
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-12-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Teclistamab pre-approval access in relapsed or refractory multiple myeloma.


Eligibility criteria: Must have relapsed/refractory multiple myeloma (RRMM) and have evidence of disease progression after last therapy. Must have exhausted all available treatment options accessible as local standard of care (example. proteasome inhibitors \[PIs\], immunomodulatory imide drugs \[IMIDs\], anti CD38 monoclonal antibodies \[mAbs\] and therapies targeting Exportin 1 \[XPO1\] and B cell maturation antigen \[BCMA\]). Must not be eligible for a clinical trial with teclistamab or other medicines in this setting

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT03154398: Thyroid Dysfunction in Patients With Type 2 Diabetes With Early Diabetic Nephropathy.
Official title: Thyroid Dysfunction in Patients With Type 2 Diabetes With Early Diabetic Nephropathy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Evaluation Thyroid Functions in Diabetic Patient
Keywords: evaluation of thyroid function in diabetes patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: type 2 diabetes with early nephropthy

Brief summary: Diabetes Mellitus is the most common disorder seen. The impact of this disease on the quality of life, and on morbidity and mortality through the complications that affect the small and large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease has been emphasized by the findings of the national commission (USA) on diabetes .

So, there was curiosity to understand and learn the association of this disorder with another common endocrine gland function that is thyroid gland . The association between these two disorders has long been recognized although the prevalence of thyroid dysfunction in diabetic population varies widely between studies. With insulin and thyroid hormone being intimately involved in cellular metabolism and thus excess or deficit of these hormones result in functional derangement of the other .

Diabetic patients have higher prevalence of thyroid disorder when compared with the normal population. Diabetic women are more frequently affected than men and hypothyroidism is more common than thyrotoxicosis.

As Hyperthyroidism impairs glycemic control in diabetic subjects, while hypothyroidism may increase susceptibility to hypoglycemia thus complicating diabetes management so Severe diabetic complications where noted in patients with sub- clinical hypothyroidism . Sub-clinical hypothyroidism is an independent risk factor for development of diabetic nephropathy.

Detailed description: Recognition and treatment of thyroid dysfunction in diabetic patients will benefit glycemic control and improve general well-being Diabetic nephropathy, a major microvascular complication of type 2 diabetes mellitus, is an important cause of chronic kidney disease. It results from interactions between hemodynamic and metabolic factors.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus and with diabetic nephropathy.

Exclusion Criteria:

* 1) Insulin dependent diabetes 2) Patients with:

  * Gestational diabetes mellitus.
  * Steroid induced Diabetes.

    3) Thyroid disease

Primary outcomes:
measure: the percentage of patients progress to advanced diabetic nephropathy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University
Study officials:
affiliation: Assiut University
name: maria hamdy
role: STUDY_DIRECTOR
References:
Clinical trial NCT01255098: A Development Plan of in Vitro Diagnostics of Immuno Magnetic Reduction Assay - A Rapid Etection Kit of Enterobacteraceae in Blood or Blood Culture
Official title: A Development Plan of in Vitro Diagnostics of Immuno Magnetic Reduction Assay - A Rapid Etection Kit of Enterobacteraceae in Blood or Blood Culture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immuno Magnetic Reduction
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: emergency cases

Brief summary: This plan is to develop blood culture or to measure diagnostics of Immuno Magnetic Reduction assay in the first stage.


Eligibility criteria: Inclusion Criteria:

* emergency cases
* blood culture of positive and negative cases which storage in 4℃ every day

Exclusion Criteria:

* not emergency cases of blood culture

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Giueng-Chueng Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04438798: High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section
Official title: A Prospective Randomized Study of High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxic Brain Injury
Maternal Death
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) using high flow oxygen therapy for preoxygenation and oxygen supplementation during apnoea has shown promising results

Detailed description: Eeffective preoxygenation followed by apnoeic oxygenation enables anaesthesiologists to safely prolong the apnoea time which is the time (seconds) of apnea following preoxygenation and muscle relaxation before to peripheral oxygen saturations (SpO2) decreases by 2%.

Eligibility criteria: Inclusion Criteria:

* pregnant females
* Of American Society of Anesthesiologists (ASA) physical Status I and II
* For elective cesarean section under general anesthesia

Exclusion Criteria:

* with room air saturation of \<98%
* anticipated difficult airway
* anticipated obstetric risk factor or precious baby
* chronic obstructive pulmonary disease
* thyrotoxicosis
* pheochromocytoma
* hyperkalaemia
* significant cardiac illness

Primary outcomes:
measure: measure the time of safe apnea
timeFrame: 10 minutes after induction
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Rehab Abd Elraof Abd Elaziz
Study officials:
affiliation: Alexandria University
name: Rehab A. Abd Elaziz, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30.
Clinical trial NCT00231998: Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis
Official title: A Clinical Study Continued From the Confirmatory Study to Validate the Efficacy and Safety of Pimecrolimus Cream in Pediatric Atopic Dermatitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis, ASM981, pimecrolimus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 240
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of Pimecrolimus cream will be evaluated in Japanese pediatric patients with atopic dermatitis. This study is a 6-month extension study following core study.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES


Eligibility criteria: Inclusion Criteria:

* - Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator
* Patients whose guardians have given written informed consent to participation in this study

Exclusion Criteria:

* - Patients who failed in treatment compliance in the core study
* Patients who had a major violation of the protocol in the core study

Primary outcomes:
measure: Safety assessed by adverse events (AEs)
Secondary outcomes:
measure: Number of flares during 26 weeks of treatment
Other outcomes:
Locations:
city: Various Cities
country: Japan
facility: This study is not being conducted in the United States
Study officials:
affiliation: Novartis Pharmaceuticals Japan
name: Novartis Pharmaceuticals Japan
role: STUDY_CHAIR
References:
Clinical trial NCT02959398: Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions
Official title: EVALUATION DE LA TOMOSYNTHESE DANS LA CARACTERISATION ET LA PRISE EN CHARGE DES LESIONS MAMMAIRES : "ETOLE"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Tomosynthesis
BRCA1 Protein
BRCA2 Protein
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Tomosynthesis is an innovative technique developed in digital mammography for obtaining a sectional image of the breast. Mammography has the main disadvantage of being an imaging projection that creates overlays, which eliminates tomosynthesis.

The objective of this study is to evaluate if the BI-RADS classification obtained by tomosynthesis with synthetic mammography is superior to that obtained by conventional mammography in terms of specificity while not inferior in terms of sensitivity.


Eligibility criteria: Inclusion Criteria:

* Patient having clinical or breast imaging abnormalities classified as BiRads 3, 4, 5 (Table 1). (5)
* Patient over 18 years old
* Signed informed consent

Exclusion Criteria:

* Patients at high risk of breast cancer, mutations BRCA 1 (BReast CAncer gene 1) or BRCA 2 (BReast CAncer gene 2) carriers, Li Fraumeni, or history of thoracic radiation will be excluded because of their greater sensitivity to ionizing radiation.
* Patient unable to give informed consent for physical, mental, or legal reasons.
* Patient not affiliated with French Social Security Insurance.
* Patient under treatment for breast cancer.
* When mammography is not recommended according to good practice by the French Health Authority (HAS).
* Pregnant patient.

Primary outcomes:
measure: Breast Imaging-Reporting And Data System (BI-RADS) scale
timeFrame: Day 1
Secondary outcomes:
measure: Criteria for a poor prognosis
timeFrame: Day 1
measure: Number of additional examinations
timeFrame: Day 30
measure: The number of ultrasound exams
timeFrame: Day 30
measure: Total radiation dose
timeFrame: Day 30
measure: Cost of the diagnostic strategies
timeFrame: Day 30
measure: Agreement between readers
timeFrame: Day 1
measure: Cumulative incidence of Breast cancer diagnosis
timeFrame: Month 24
Other outcomes:
Locations:
city: Paris
country: France
facility: hopital Saint-Louis
city: Paris
country: France
facility: Hopital Tenon
Study officials:
References:
Clinical trial NCT00482898: A Study of MK0359 in Patients With Chronic Asthma (0359-013)
Official title: A Multicenter, Randomized, Double-Blind, Crossover Study Comparing the Effect of MK0359 and Placebo in Adult Patients With Chronic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-06-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to test the effect of MK0359 in lessening the symptoms of asthma as compared to placebo.


Eligibility criteria: Inclusion Criteria:

* You are between the ages of 18 and 45
* You have had a history for at least a year of COPD symptoms
* Your current asthma treatment is limited to short-acting beta-agonists(such as albuterol)
* You have a history of smoking one pack of cigarettes per day for 7 years
* You will not be away from home for more than 5 days during the study

Exclusion Criteria:

* You are unwilling to limit your alcohol use to less than 5 drinks per week
* You have been in a research study with an investigational drug or vaccine in the last 4 weeks
* You have donated blood in the last 4 weeks
* You have been hospitalized or had major surgery in the last 4 weeks
* You have been treated in the emergency room within the last 4 weeks or hospitalized within the last 3 months for your asthma
* You have a history of heart problems in the last 6 months
* You have a history of stomach problems
* You are unwilling to avoid grapefruit juice throughout the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lu S, Liu N, Dass SB, Reiss TF, Knorr BA. Randomized, placebo-controlled study of a selective PDE4 inhibitor in the treatment of asthma. Respir Med. 2009 Mar;103(3):342-7. doi: 10.1016/j.rmed.2008.10.024. Epub 2009 Jan 8.
Clinical trial NCT03536598: Study to Evaluate the Safety and Efficacy of CJ-30060 in Hypertensive Patients With Hyperlipidemia
Official title: A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of CJ-30060 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Rosuvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension With Hyperlipidemia
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2018-05-24
Enrollment: 203
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of CJ-30060 compared with amlodipine/valsartan combination therapy and valsartan/rosuvastatin combination therapy in hypertensive patients with hyperlipidemia


Eligibility criteria: Inclusion Criteria:

* Aged between 19 and 74 years
* Patient with dyslipidemia and hypertension

Exclusion Criteria:

* At screening, siSBP ≥ 200 mmHg or siDBP ≥ 120mmHg or LDL-C \> 250mg/dL or TG ≥ 400mg/dL
* At screening, siSBP difference is ≥ 20 mmHg or siDBP difference is ≥10 mmHg
* Secodary hypertension
* Type I or uncontrolled diabetes mellitus (HbA1c ≥ 9 %)

Primary outcomes:
measure: Change of LDL-C and siSBP
timeFrame: baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Dong Ju Choi, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: