louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04329455: Evaluation of Endoscopic Thyroidectomy Via Axillo-breast Approach in Thyroid Nodules
Official title: Evaluation of Endoscopic Thyroidectomy Via Axillo-breast Approach in Thyroid Nodules
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Safety and Cosmetic Issues in Endoscopic Thyroidectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 patients age group 18_55 years with unilateral or bilateral thyroid nodules benign according to preoperative FNAC and normal thyroid function

Brief summary: Evaluation of Endoscopic Thyroidectomy via Axillo-breast Approach in Thyroid Nodules regarding safety and cosmetic outcomes


Eligibility criteria: Inclusion Criteria:

* benign thyroid nodules unilateral or bilateral Normal thyroid function

Exclusion Criteria:

* malignant Thyroid Nodules Recurrent goitre Toxic goitre

Primary outcomes:
measure: Safety of Endoscopic Thyroidectomy
timeFrame: 2020_2023
Secondary outcomes:
measure: Cosmetic outcome of Endoscopic Thyroidectomy
timeFrame: 2020_2023
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Gamal
Study officials:
References:
Clinical trial NCT02869555: Institut Paoli Calmettes Multiple Myeloma Database
Official title: Institut Paoli Calmettes Multiple Myeloma Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of multiple myeloma

Brief summary: Database of Institut Paoli-Calmettes patients diagnosed with multiple myeloma


Eligibility criteria: Inclusion Criteria:

* Multiple myeloma diagnosis

Exclusion Criteria:

* Diagnosis before 1st january 2008

Primary outcomes:
measure: Survival of patients
timeFrame: 10 years
Secondary outcomes:
measure: Collection of patients characteristics
timeFrame: 10 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du Rhône
Study officials:
References:
Clinical trial NCT04919655: Primary Lymphedema and Mutation CELSR1 (Cadherin EGF LAG Seven-pass G-type Receptor 1)
Official title: Clinical and Functional Expression Associated With CELSR1 Mutations in Primary Lymphedema of Lower Limbs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Lymphedema
Keywords: CELSR1
primary lymphedema of lower limbs
lymphedema
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: GEHU - Duve Institute - Bruxelles
First posted: 2021-06-09
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary lymphedema of lower limbs, which carriewho carry d the codon stop or the amino acids substitution CELSR1 mutation, followed up at Montpellier University Hospital regardless of the age.

Brief summary: The investigators will describe the expression of mutation CELSR1 with codon stop and amino acids substitution mechanism in primary lymphedema, in both clinical examination and imaging exploration

Detailed description: According to the literature, it seems that the mutation of the CELSR1 gene is associated with primary lymphedema.

Thus, the investigators have identified families with CELSR1 mutation with codon stop or animo acid substitution mechanisms among patients followed up in vascular medicine department, at Montpellier University hospital for primary lymphedema of lower limbs.

Among the mutation carriers, the investigators have collected the clinical examinations and imaging exploration results, realized systematically during the follow up of all the patient with primary lymphedema (venous Doppler, MRI of the lymphatic system, lymphoscintigraphy of the lower limbs, abdominal ultrasound), in order to search for a morphological and functional pattern associated with the mutation.

Eligibility criteria: Inclusion criteria:

* Patient followed up in vascular medicine departement at Montpellier University Hospital for primary lymphedema of lower limbs, who carries the CELSR1 mutation with codon stop or amino acids substitution mechanism.
* Relatives to the index case who carry the mutation for the segregation study.

Exclusion criteria:

* Patients who carry another mutation than CELSR1 responsible for primary lymphedema
* Syndromic form of primary lymphedema
* Patient not followed up at Montpellier University Hospital.

Primary outcomes:
measure: Presence of unilateral lymphedema of lower limbs
timeFrame: day 1
measure: type of the morphological and functional pattern with imaging exploration.
timeFrame: day 1
Secondary outcomes:
measure: determine if deactivator mutation of CELSR1
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: MESTRE GODIN Sandrine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00818155: Study Evaluating the Safety, Tolerability and Pharmacokinetics of Desvenlafaxine Succinate SR in Healthy Chinese Male and Females
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Desvenlafaxine Succinate Sustained Release Administered Orally to Healthy Chinese Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of desvenlafaxine succinate SR in healthy male and female Chinese subjects. The amount of drug in the body and the effects of the drug will also be evaluated.


Eligibility criteria: Inclusion:

1. Men or non-pregnant, non-lactating women, 18 to 45 years of age inclusive on study day 1.
2. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)
3. Nonsmoker or smoker of fewer than 10 cigarettes (half a pack) a day.

Exclusion:

1. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
2. History of epilepsy or seizure disorder (except history of a single childhood febrile seizure).

Primary outcomes:
measure: Safety and tolerability as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, cardiac rhythm monitoring, 12 lead ECG and clinical laboratory results.
timeFrame: 2 months
Secondary outcomes:
measure: Pharmacokinetics as evaluated from blood and urine concentrations of desvenlafaxine
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02253355: PINS Stimulator System for Patients With Treatment Resistant Depression
Official title: PINS Stimulator System for Patients With Treatment Resistant Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Treatment-Resistant Depression
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tiantan Hospital
First posted: 2014-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effects and safety of Deep Brain Stimulation (DBS) to treat on patients with Treatment-Resistant Depression (TRD) and using functional magnetic resonance imaging (fMRI)to evaluate the influence of acupuncture on patients, which will be afford objective evidence for the mechanism of Acupuncture on depression.


Eligibility criteria: Inclusion Criteria:

1. Subject is aged ages 20-70 years
2. Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria
3. First episode onset before age 45
4. Current episode \> 12 months duration
5. In the current episode: Documented resistance (i.e. persistence of the major depressive episode) to a minimum of 4 adequate depression treatments from at least 3 different treatment categories (e.g. SSRI's)
6. SNRI's, TCA's, MAO-inhibitors, Mirtazipine, Nefazodone, Trazodone, Bupropion, lithium augmentation, thyroid augmentation, ECT); Adequacy of treatments as defined by a score of at least 3 according to the amended Antidepressant Treatment History Form (ATHF) criteria
7. Hamilton Depression Rating Scale (HDRS) of \> 20 at 3 separate baseline visits, rated by 2 separate psychiatrists, Baseline 2 and Baseline 3 HDRS scores cannot improve ≥ 25%

Exclusion Criteria:

1. Patients with hearing impairment
2. Failures of important organs and in severe conditions
3. Be reluctant or disabled to receive neuropsychological assessments;
4. Participate in other clinical trial
5. Has a life expectancy of \< 1 year
6. The investigator and/or enrollment review committee, would preclude participation in the study

Primary outcomes:
measure: Changes in the Hamilton Depression Rating Scale-17
timeFrame: 1, 3, 6 and 12 months of stimulation
Secondary outcomes:
measure: The incidence of all adverse events
timeFrame: 1, 3, 6 and 12 months of stimulation
Other outcomes:
Locations:
Study officials:
affiliation: Tsinghua University
name: Li Luming, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03999255: SEARCH FOR OPTIMAL ANAESTHESIA IN RETROGRADE INTRARENAL SURGERY
Official title: REDUCING KIDNEY MOTION: OPTIMIZING ANESTHESIA AND COMBINING RESPIRATORY SUPPORT FOR RETROGRADE INTRARENAL SURGERY: A PILOT STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stone
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Patients undergoing retrograde intrarenal surgery for kidney stones from November 2017 to May 2018 were prospectively recruited to participate in the study. In each case after the beginning of general anesthesia with mechanical ventilation surgeons were asked to assess the mobility of the operative field and conditions for laser lithotripsy according to the developed questionnaire scale. The questionnaire consisted of 5 degrees of assessment of kidney mobility and each question was scored from 1 to 5, 1 being very mobile (extremely poor conditions for dusting) and 5 completely immobile (Ideal conditions for dusting). After this assessment modified technique of general anesthesia was applied called combined respiratory support which consisted of reduction of tidal volume to 250-300 ml and respiratory rate to 4-5 per minute with transcatheter high frequency jet ventilation through endotracheal tube with a respiratory cycle frequency of 300 per minute and maintained during retrograde intrarenal surgery. At the beginning of combined respiratory approach, surgeons were once again asked to assess the mobility of the operative field and the conditions for laser lithotripsy. Main ventilation parameters were recorded and compared in both regimens.


Eligibility criteria: Inclusion Criteria:

* Kidneys stones with indications for retrograde intrarenal surgery

Exclusion Criteria:

* Patients with ASA class of greater than 3
* Patients with active urinary tract infection were excluded from the study

Primary outcomes:
measure: Kidney motion assessed by the endourologist during retrograde intrarenal surgery
timeFrame: duration of RIRS Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: First Pavlov Saint Petersburg Universuty
Study officials:
References:
citation: Gadzhiev N, Oibolatov U, Kolotilov L, Parvanyan S, Akopyan G, Petrov S, Cottone CM, Sung J, Okhunov Z. Reducing kidney motion: optimizing anesthesia and combining respiratory support for retrograde intrarenal surgery: a pilot study. BMC Urol. 2019 Jul 5;19(1):61. doi: 10.1186/s12894-019-0491-3.
Clinical trial NCT01278355: Assessing the Feasibility of Integrating Ear Acupuncture Into the Aeromedical Evacuation System From RAB to AAFB
Official title: The Feasibility of Integrating Ear Acupuncture for Pain in Patients Being Transported Via the Aeromedical Evacuation System From Ramstein Air Base to Andrews AFB, Maryland USA: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Pain
Keywords: pain
acupuncture
Lead sponsor: Samueli Institute for Information Biology
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Military beneficiaries undergoing aeromedical evacuation from Ramstein Air Base to Andrews Air Force Base who are experiencing pain.

Brief summary: The purpose of this study is twofold: 1) to test the feasibility of integrating a simple bilateral ear acupuncture procedure (Auricular Stimulation Procedure - ASP) into the standard care delivered in the Aeromedical Evacuation system and 2) to observe and document any changes in pain scores and in-flight related symptoms and factors (e.g. sinus block/pain, ear block pain, nausea/air sickness) typically monitored during transportation of wounded warriors from Ramstein Air Base (RAB) to Andrews Air Force Base (AAFB).


Eligibility criteria: Inclusion Criteria:

* Age 18 or over
* NRS Pain rating \> 0
* Military beneficiaries undergoing aeromedical evacuation from RAB to AAFB

Exclusion Criteria:

* Medically unstable or otherwise unable to participate including those with the inability to consent
* Allergy to metals
* Ear trauma
* Sepsis
* Unhealed wounds on the ears
* Piercing or scar tissue in any of the ear acupuncture point areas
* Pregnancy

Primary outcomes:
measure: Pain
timeFrame: March 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Ramstein
country: Germany
facility: Ramstein Air Base
Study officials:
affiliation: United States Air Force
name: Richard Niemtzow, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04815655: Cartilage Tympanoplasty for Recurrent Perforation Full Thickness Versus Partial Thickness Graft
Official title: Cartilage Tympanoplasty for Recurrent Perforation Full Thickness Versus Partial Thickness Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cartilage Tympanoplasty
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cartilage tympanoplasty for recurrent perforation full thickness versus partial thickness graft.

Detailed description: To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer

Eligibility criteria: Inclusion Criteria:

1 -patients with safe chronic suppurative otitis media 2- patients with recurrent perforations 3- patients with conductive hearing loss- 4- patients above 18 years

Exclusion Criteria:

1. active infection
2. sensorineural hearing loss
3. compromised immune system 4 - patients age below 18 years

Primary outcomes:
measure: To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hamza Elshafie, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01814514: Safety Study of Aqueous Suppression After Ahmed Glaucoma Valve (AGV) Implantation
Official title: Early Intra Ocular- Pressure Control Using Aqueous Suppressive Agents After Ahmed Glaucoma Valve Implantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hypertensive Phase
Keywords: hypertensive
phase
success rate
AGV
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2013-03-20
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The AGV implant is designed to open when the IOP is between 8 mmHg and 10 mmHg, and thus maintains an IOP of 8 mmHg or higher. In the early period after glaucoma drainage device (GDD) surgery the intraocular pressure (IOP) classically goes through 2 phases. The hypotensive phase occurs immediately after surgery, lasts around 1 week. This is followed by the hypertensive period where the IOP tends to rise steadily above 21mmhg.

The hypertensive response seems to occur more commonly after Ahmed GDD surgery than nonvalved implants, It was reported to occur in 40% to 80% of cases. Although the hypertensive phase can last as long as 6 months it is usually during the first 1 to 4 weeks, when there is intense congestion of the bleb wall, that IOP is highest.

Previous study showed that when aqueous comes into contact with conjunctiva and Tenon's capsule,an inflammatory reaction occurs.Factors such as prostaglandins, eicosanoids, tissue growth factor beta (TGF β)has been shown to occur in glaucomatous aqueous. These mediators induce an inflammatory reaction, and if excessive, will result in fibrosis and poor functioning of the bleb. High pressure within the bleb also results in the secretion of TGF β by the bleb lining. It may result in inflammation of the bleb wall and subsequent fibrosis and poor bleb function. The investigators supposed that with early use of aqueous suppressant medication after AGV implantation, the concentration of inflammatory mediators decreased in subconjunctival space and may lead to better IOP control after shunt surgery.


Eligibility criteria: Inclusion Criteria:

* patients with uncontrolled glaucoma requiring AGV device implantation.

Exclusion Criteria:

1. History of AGV implantation
2. Allergy to Anti glaucoma medication
3. unable to come for follow up
4. Known contraindication to beta blacker such as asthma- chronic obstructive pulmonary disease (COPD). Heart failure heart block
5. Learning difficulty- mental illness or severely ill

Primary outcomes:
measure: intraocular pressure-hypertensive phase success rate
timeFrame: during first 3 months
Secondary outcomes:
measure: intraocular pressure success rate
timeFrame: after 12 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Labbafinejad medical center
Study officials:
References:
Clinical trial NCT02818114: Peer Enhanced Prolonged Exposure
Official title: Peer Enhanced Exposure Therapy (PEET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: PTSD
Prolonged Exposure
Peer Support
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-06-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Peer specialist led individual education and support for veterans receiving Prolonged Exposure Therapy
Primary purpose: TREATMENT

Brief summary: The investigators plan to develop and test an intervention using peer specialists (Veterans who have managed PTSD and completed PE) to provide support services for Veterans using prolonged exposure therapy.

Detailed description: The investigators will use qualitative data from Veterans and PE providers to revise the investigators' manualized intervention for peer support services, then complete a feasibility trial to assess the feasibility and acceptability of Peer Enhanced Prolonged Exposure

Eligibility criteria: Inclusion Criteria:

* Veteran participants will be individuals appropriate for PE, i.e., :

  * Veterans who are currently seeking PE
  * meet DSM-5 criteria for PTSD or subthreshold PTSD
  * are competent to consent to research

Exclusion Criteria:

* Veteran participants do not have levels of other types of psychopathology that would prevent successful participation in the intervention

Primary outcomes:
measure: PE Sessions Attended
timeFrame: 10 weeks
measure: Posttraumatic Stress Disorder (PTSD) Checklist-5
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Jeanette I. Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References: