louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00784407: Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study
Official title: Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroidectomy
Keywords: thyroid surgery
total thyroidectomy
harmonic scalpel
Lead sponsor: Hippocration General Hospital
Sponsor class: OTHER
First posted: 2008-11-04
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE).

Detailed description: Although the harmonic scalpel has been shown to be safe and effective in thyroid surgery, several surgeons consider the previously available instruments to be large and cumbersome, especially in terms of tissue fine grasping and dissection capabilities. To this context, an innovative technical improvement of the device for thyroid surgery has very recently been implemented and has been made available in 2008. Utilization of this new device, however, has not been evaluated in any study. The objective of this prospective randomized study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE) in respect to hemostasis, operative time and postoperative complications. All patients submitted to total thyroidectomy are randomized into two groups: those submitted to total thyroidectomy using the FOCUS device (group Α) and those with HARMONIC ACE (group Β).

Eligibility criteria: Inclusion Criteria:

* total thyroidectomy

Exclusion Criteria:

* hemithyroidectomy
* additional surgical procedures together with the total thyroidectomy (i.e. parathyroidectomy or cervical lymph node dissection)

Primary outcomes:
measure: Hemostasis
timeFrame: intraoperatively & postoperatively
measure: Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
timeFrame: postoperatively
measure: Operative time
timeFrame: from skin incision to skin closure
Secondary outcomes:
measure: Length of hospital stay
timeFrame: postoperatively
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens
state: Abelokipoi (Q. Sofias 114 av.)
Study officials:
affiliation: Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens, Athens, Greece
name: Andreas Manouras, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05385107: Value of PCT When Diagnosing Candidemia
Official title: Value of PCT When Diagnosing Candidemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Value of Procalcitonin in Patients With Suspected Candidemia
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care patients

Brief summary: This study is a retrospective analysis to identify and compare the shift in inflammatory biomarkers in ICU patients immediately before and after the first identification of candidemia.

Detailed description: As above.

Eligibility criteria: Inclusion Criteria (all has to be fullfilled):

* ICU patients with blood cultures showing growth of Candida species
* clinical records including daily data on WBC, CRP, Procalcitonin and body temperature

Exclusion Criteria:

* Age lower than 18 years
* blood cultures with growth of Candida species before ICU admission
* incomplete records of daily WBC, CRP, Procalcitonin or body temperature

Primary outcomes:
measure: Absolute procalcitonin concentration
timeFrame: 9 days
measure: Shift (trend) procalcitonin concentration
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
Study officials:
References:
Clinical trial NCT00480207: Folic Acid and Omega -3 Fatty Acid Supplementation in Depressed Older Adults
Official title: Randomized Double-blind Controlled Clinical Trial to Assess the Impact of Folic Acid and Omega-3 Fatty Acids Supplementation on the Severity of Depressive Symptoms in Older Adults With Identified Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depression
Lead sponsor: Beersheva Mental Health Center
Sponsor class: OTHER_GOV
Collaborators: name: The S. Daniel Abraham International Center for Health and Nutrition
First posted: 2007-05-30
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our specific aim is to determine the impact of folic acid and omega-3 supplementation on the severity of depressive symptoms among depressed adults aged 65 and above.


Eligibility criteria: Inclusion Criteria:

1. Age 65+ (year of birth -1942 or below)
2. Depression (as defined by the DSM-IV diagnostic criteria for depression: major or minor depression or dysthymia)

Exclusion Criteria:

1. Co-existing psychiatric disorder (except anxiety disorders)
2. Moderate and severe cognitive impairment
3. Current treatment with anticoagulants, antithrombotics and fibrinolytics
4. Current severe angina with exertion
5. Chronic renal insufficiency
6. Liver cirrhosis
7. Alcohol or drug abuse

Primary outcomes:
measure: the severity of depressive symptoms
timeFrame: baseline, 4th , 8th and 12th week
Secondary outcomes:
measure: cognitive status
timeFrame: baseline, 4th, 8th, and 12th week
measure: nutritional status
timeFrame: baseline and end of study
measure: possible side effects
timeFrame: baseline, 4th, 8th, and 12th week
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Mental Health Center
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Danit R Shahar, RD PhD
role: STUDY_DIRECTOR
affiliation: Beersheva Mental Health Center
name: Alex Palatnik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The S. Daniel Abraham International Center for Health and Nutrition
name: Larissa German, MD, MMedSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
Clinical trial NCT05489107: New Local Treatment of Radiation-induced Proctitis
Official title: New Option for the Treatment of Radiation-induced Proctitis Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiation Proctitis
Keywords: radiation
proctitis
hyaluronic acid
chondroitin sulfate
poloxamer 407
local treatment
rectoscopy
Lead sponsor: Barmherzige Brüder Vienna
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between 18 and 99 years of age with radiation proctitis under/after prior radiation therapy beacuse of oncological conditions in the pelvic area.

Brief summary: A prospective single-center observational study to evaluate the effectiveness of a local treatment with a mixture of hyaluronic acid, chondroitin sulfate and poloxamer 407 in patients with radiation-induced proctitis.


Eligibility criteria: Inclusion Criteria:

* proven symptomatic acute or chronic radiation-induced proctitis;
* current or prior radiation therapy in the pelvic area;
* patients with complications connected to the radiation therapy.

Exclusion Criteria:

* lack of informed consent;
* non-adherence to study protocol;
* pregnancy.

Primary outcomes:
measure: Number of Petechiae in the most affected areas of the rectal mucosa.
timeFrame: 1 month
Secondary outcomes:
measure: Assessment of patients' quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Proctitis Module with 20 Questions (EORTC QLQ-PRT20)
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Krankenhaus der Barmherzigen Brüder
Study officials:
affiliation: Krankenhaus der Barmherzige Brüder Wien
name: Bernhard Dauser, Assoc. Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT01840007: Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma
Official title: Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Melanoma (Stage IIIC Non-résécable or no Surgically Curable or Stage IV With Classification AJCC)
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 20
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: In western countries, melanoma represents a major mistake of public health by its frequency, lethality and the increasing of incidence. Surgery can cure melanoma diagnosed very early. In other cases, it exists a risk of recurrence of lymph node and visceral. At the stage of visceral metastases, the prognosis of melanoma is catastrophic, with a median survival of 6 months. Indeed, the reference chemotherapy by dacarbazine induces a very limited response rate of 10-20%, the ipilimumab which has been authorized in the second intention, has a response rate of 10%, and other available treatments don't have a superior efficiency. Metformin is an oral antidiabetic of biguanides family which acts by inducing the activation of AMPK, a molecule which is inactivated in many cancers including the melanoma. In agreement with these data, several preclinical studies suggested that metformin has antineoplastic activity. In the case of melanoma, a study published recently has showed that metformin inhibits proliferation of melanoma cells in vitro and we confirmed for our part these results in our laboratory (INSERM U895).


Eligibility criteria: Inclusion Criteria:

* Major patients with metastatic melanoma (stage IIIC non-résécable or no surgically curable or stage IV with classification AJCC) in progression after a first-line of treatment by vemurafenib or chemotherapy, and non-eligible or non-responders to ipilimumab.

Metastases measurable by RECIST criteria. Hematologic, renal and hepatic appropriate functions. Negative pregnancy test.

Exclusion Criteria:

* Patients with symptomatic brain metastases and Performans Status (PS)\>2. Patients with carcinomatous meningitis. Pregnant or breathfeeding women. Patients with a contraindication to the metformine. HIV infection, active infection with HBV or HCV. Patients already treated with metformin in the context of diabetes.

Primary outcomes:
measure: Response rate
timeFrame: Once time after 6 months of treatment by metformine
Secondary outcomes:
measure: the overall survival, the survival without progress (PFS), the tolerance, and the quality of life.
timeFrame: 6 times
Other outcomes:
Locations:
city: Nice
country: France
facility: Bahadoran
state: Alpes-Maritimes
city: Lille
country: France
facility: MORTIER Laurent
state: Nord
Study officials:
affiliation: Service de Dermatologie - Hôpital de l'Archet - CHU de Nice
name: BAHADORAN Philippe, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04429607: Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial
Official title: Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Sebaceous Hyperplasia
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare treatment of sebaceous hyperplasia with pulsed dye laser (PDL) plus neodymium doped yttrium aluminum garnet laser (Nd:YAG) versus erbium doped yttrium aluminum garnet (erbium:YAG) laser versus electrodesiccation and curettage (ED\&C).

This is a randomized clinical trial. Approximately 18 participants will enrolled. Each participant will have their sebaceous hyperplasia lesions randomized to receive either Erbium:YAG, PDL plus Nd:YAG, or ED\&C treatment. Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Lesions will be treated twice, 2-6 weeks after the first treatment. Lesion size and count will be measured before treatment and at follow-up 4-12 weeks after the first treatment. This study is a pilot study designed to determine the feasibility of these procedures.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.


Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age
2. Receiving cosmetic treatment for sebaceous hyperplasia
3. In good general health as assessed by the investigator
4. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

1. Patient pregnant or nursing
2. Patient with history of poor wound healing that would result in hypertrophic scar or keloid at the discretion of the physician
3. Patient with recent sun exposure that would result in pigment changes at the discretion of the physician
4. Subject unwilling to sign an IRB approved consent form
5. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible

Primary outcomes:
measure: Change in size of sebaceous hyperplasia
timeFrame: 4-12 weeks
measure: Change in sebaceous hyperplasia lesion count
timeFrame: 4-12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00178607: Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia
Official title: Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Keywords: Inhibitors
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 99
Sex: MALE
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with Severe Hemophilia A and a positive inhibitor

Brief summary: To correlate the Human Leukocyte Antigen type and genetic defect with hemophilia A.

Detailed description: One of the most serious complications of treatment in patients with hemophilia A or hemophilia B is the development of an inhibitor, which is an antibody that neutralizes the factor VIII or IX coagulant activity. Up to one fourth of patients with severe hemophilia A develop an inhibitor but at present it is not possible to predict which patients will develop such antibody. The ability to predict an inhibitor development at an individual level would greatly improve therapeutic approach to this serious problem

Eligibility criteria: Inclusion Criteria:

* Severe Hemophilia A with an inhibitor level of 0.6 B.U. or higher

Exclusion Criteria:

* Severe Hemophilia A with a negative inhibitor

Primary outcomes:
measure: Inactivation of antibodies by the FVIII covalent reactive analogs
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Univeristy of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Miguel Escobar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04118907: Different Stimuli Were Given to Patients With Chronic Pure Tone Tinnitus to Verify the Effective Treatment of Tinnitus.
Official title: Effects of Sound Stimulation, Somatosensory Stimulation, Vestibular Stimulation and the Combinations on Tinnitus Loudness and Tinnitus Related Distress in Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Acoustic Stimulation
Somatic Stimulation
Vestibular Stimulation
Keywords: tinnitus
stimulation
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this experiment, patients with chronic pure tone tinnitus were divided into three groups to receive auditory stimulation, somatosensory stimulation, vestibular stimulation and combined stimulation, in order to find an effective way to treat tinnitus

Detailed description: 120 patients with chronic pure tone tinnitus over 6 months were randomly divided into 6 groups, one group was given auditory stimulation, one group was given somatosensory stimulation, one group was given auditory stimulation + somatosensory stimulation, one group was given auditory stimulation + vestibular stimulation, the last group was given auditory stimulation + somatosensory stimulation + vestibular stimulation.

Eligibility criteria: Inclusion Criteria:

* Pure tone tinnitus
* Unilateral and bilateral
* female and male
* Tinnitus has a history of more than 6 months

Exclusion Criteria:

* Pulsatile tinnitus of blood vessel
* Meniere's disease
* Chronic headache
* Neurological diseases (such as brain tumors)
* Patients with mental / mental illness undergoing treatment
* Pregnant women and patients with other untreatable diseases

Primary outcomes:
measure: Electrical audiometry and acoustic impedance
timeFrame: Three months from the time the patient was selected to the end of the stimulus
measure: Tinnitus frequency and loudness
timeFrame: Three months from the time the patient was selected to the end of the stimulus
measure: Tinnitus disability scale
timeFrame: Three months from the time the patient was selected to the end of the stimulus
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: E.N.T. department of the First Affiliated hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: E.N.T. department of the First Affiliated hospital of Anhui Medical University
name: Busheng Tong, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04199507: Physical Fitness in Autism
Official title: Comparison of Postural Disorders and Physical Fitness Parameters, Family Anxiety Level and Quality of Life Between Individuals With Autism and Healthy Individuals Who Continue Physical Activity Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 36
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Autism is a spectrum disorder, each person with autism has a distinct set of strengths and challenges. The ways in which people with autism learn, think and problem-solve can range from highly skilled to severely challenged. Some people with ASD may require significant support in their daily lives, while others may need less support and, in some cases, live entirely independently.

Brief summary: Although there are some studies investigating the physical activity levels of children with autism in the literature, no comprehensive study investigating the relationship between posture and physical fitness parameters, family anxiety level and quality of life of individuals with autism who have continued physical activity program has not been found. The aim of our study is to compare postural disorders and physical fitness parameters, family anxiety level and quality of life between individuals with autism and healthy individuals attending physical activity program.


Eligibility criteria: Inclusion Criteria:

1. Being diagnosed with mild to moderate autism,
2. To have the ability to emulate,
3. To have a cognitive level and cooperation capacity that will not hinder the implementation of assessment scales,

Exclusion Criteria:

1. Having any systemic chronic disease and neurological disorder
2. During the last 6 months, individuals wih autism in the process will affect physical fitness for fracture, surgery and so on.

Primary outcomes:
measure: Physical fitness
timeFrame: 1 month
Secondary outcomes:
measure: Posture analysis
timeFrame: 1 month
measure: Physical activity level
timeFrame: 1 month
measure: Family Anxiety Level
timeFrame: 1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT05014607: Personalized Multi-peptide Vaccination in Combination With the TLR1/2 Ligand XS15 in Cancer Patients
Official title: Personalized Multi-peptide Vaccination in Combination With the TLR1/2 Ligand XS15 in Cancer Patients
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Cancer
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2021-08-20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The aim of this project is to provide personalized multi-peptide vaccination in combination with the TLR1/2 ligand XS15 to individual patients with advanced solid and hematological malignancies without any approved treatment options.

Detailed description: Ethics: Patient treatment will be conducted according to §13 Absatz 2b, AMG.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of advanced malignant disease
* Advanced malignant disease without any available standard of care treatment option
* Low tumor cell burden
* Live expectancy \> 6 month
* Ability to understand and voluntarily sign an informed consent form.
* Ability to adhere to the study visit schedule and other protocol requirements
* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.

Exclusion Criteria:

* Pregnant or lactating females.
* Treatment regimens inducing sever T cell deficiencies
* Treatment-related side effect \> CTC grade 2 (CTCAE V5.0
* Participation in any clinical study or having taken any investigational therapy, which would interfere with the studys primary and secondary end points within 2 weeks prior to vaccination
* Pre-existing auto-immune disease except for Hashimoto thyroiditis and mild (not requiring immunosuppressive treatment) psoriasis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CCU Translational Immunology, University Hospital Tübingen, Germany
name: Helmut R Salih, MD
role: STUDY_CHAIR
References: