louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00208702: Thyroid Medication and Antidepressants for Treating Major Depression
Official title: Thyroid Axis in Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Keywords: Major Depressive Disorder
Mental Health
Depression
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-21
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of treatment with supplemental triiodothyronine (T3, Cytomel) and sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), in improving symptoms of major depressive disorder (MDD).

Detailed description: The primary hypothesis is that triiodothyronine (Cytomel) supplementation of the antidepressant sertraline (Zoloft) will result in a greater improvement in HAM-D scores compared to placebo in the treatment of Major Depressive Disorder (MDD).

The goals of this proposal are to examine the relationship between Major Depressive Disorder (MDD) and abnormalities of the hypothalamic pituitary thyroid (HPT) axis. This protocol will systematically examine the value of supplemental triiodothyronine (T3, Cytomel) with sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI) in the treatment of MDD. The focus will be on two overlapping populations: 1) those with evidence of HPT abnormalities, and 2) those who did not respond to a previous adequate SSRI trial

Eligibility criteria: Inclusion Criteria:

* Male or female between the ages of 18 and 60. (The upper age is limited to 60 because thyroid changes, including blunting of the TSH response to TRH occurs with age and can potentially confound the relationship between the HPT axis and MDD.)
* Primary diagnosis of unipolar Major Depressive Disorder
* HAM-D (21 item) score \>18

Exclusion Criteria:

* Alcohol abuse or alcohol dependence within the past year.
* Psychoactive substance abuse or dependence within the past year.
* Clinical evidence of severe Personality Disorder that would make study participation and completion unlikely.
* ECT within the past 6 months.
* Grade I hypothyroidism defined as low thyroid hormone levels with an associated elevated TSH; hyperthyroidism defined as elevated thyroid hormone concentrations with a low TSH.
* Serious and unstable medical illnesses.

Primary outcomes:
measure: MADRS score
Secondary outcomes:
measure: CGI
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Boadie W Dunlop, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garlow SJ, Dunlop BW, Ninan PT, Nemeroff CB. The combination of triiodothyronine (T3) and sertraline is not superior to sertraline monotherapy in the treatment of major depressive disorder. J Psychiatr Res. 2012 Nov;46(11):1406-13. doi: 10.1016/j.jpsychires.2012.08.009. Epub 2012 Sep 7.
Clinical trial NCT03333902: The Comparison Of Nerve Blocks In Cesarean Delivery
Official title: The Comparison Of Different Nerve Blocks For Postoperative Analgesia In Cesarean Delivery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Obstetrical
Keywords: quadratus lumborum block
anesthesia
pain, postoperative
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 102
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of different kinds of popular peripheral nerve blocks for postoperative analgesia after cesarean delivery is completed, compared with traditional epidual analgesia.

Detailed description: Visual Analogue Scale (VAS) and morphine consumption was adopted to evaluate the pain relief.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II
* weight from 50 to 70 kilogrammes
* a normal singleton pregnancy
* ≥37 weeks gestation

Exclusion Criteria:

* congenital coagulopathy
* anatomic abnormalities
* localized skin infection
* allergy to any of the drugs used

Primary outcomes:
measure: the change trend of Visual Analogue Scale (VAS) at rest and movement
timeFrame: 0-48 hours postoperatively
Secondary outcomes:
measure: total morphine consumption
timeFrame: 0-48 hours postoperatively
measure: complications
timeFrame: 0-48 hours postoperatively
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
citation: Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
Clinical trial NCT00202202: User Satisfaction Survey - Personality Disorder Service
Official title: Survey of the Consultation Service of the Providence Continuing Care Centre Personality Disorder Service Users Satisfaction With the Change in Service Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: personality disorder
user satisfaction
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Can we improve our community partners satisfaction with a change in how psychiatric consultations are delivered to their clients by our psychiatrist? This survey of users of the service will compare the level of satisfaction before(retrospectively) to after the way the service is provided is changed.

Detailed description: As part of the personality disorder services continuing quality improvement enterprise we sought to review the impact of restructuring on the satisfaction of service community partners with our changed consultation service.

The consultation service was changed as the result of administrative review,part of a larger institution wide process. To review how this change was perceived by agency and individual care providers those who had received consult reports from the last fifty consultations were surveyed about their satisfaction and compared prospectively to the satisfaction of the agencies and individual care providers of clients receiving the next fifty consultations delivered in the new format.

The administrative review had indicated that the consultation reports were unnecessarily comprehensive and in the process time consuming and thereby interfered with timely access to appointments and involved excessive turn around time in the generation of reports. A new streamlined approach using a fill in the blanks type form and brief cover letter and the use of a follow up phone call to the main care giver the same day was devised to address these concerns.

Satisfaction in regards to advice received, length of the report, waiting times for the appointment and for the delivery of the report,legibility and overall satisfaction were surveyed. The satisfaction with telephone feed back was also surveyed.

Eligibility criteria: Inclusion Criteria:

* clients referred to the Personality disorder service

Exclusion Criteria:

* self referred clients

Primary outcomes:
measure: eight item user satisfaction survey on receipt of the consult report
timeFrame: in the year before and after the change in interview format
Secondary outcomes:
measure: demographic factors of the respondents as relate to their satisfaction at time of survey
timeFrame: at the time of suvey completion
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Providence Care Mental Health Services
state: Ontario
Study officials:
affiliation: Queens University
name: Stephen H McNevin, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04834102: COVID-19 Induced Telogen Effluvium
Official title: COVID-19 Induced Telogen Effluvium
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Telogen Effluvium
SARS-CoV Infection
Alopecia
Keywords: Telogen Effluvium
Covid-19
Alopecia
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults that are diagnosed with COVID-19 in the past year.

Brief summary: This study inquires about the development of Telogen effluvium following the SARS-CoV-2 infection

Detailed description: Telogen effluvium (TE) is one of the most common causes of non-scarring alopecia. During the COVİD-19 pandemic, there is an increased number of Telogen effluvium patients.This study inquires about the development of Telogen effluvium following the SARS-CoV-2 infection and correlation between the severity of covid-19 and TE.

Eligibility criteria: Inclusion Criteria:

* Sars-CoV-2 infection in the past year

Exclusion Criteria:

* Other common causes of Telogen effluvium ( such as anemia, iron deficiency, thyroid dysfunction)

Primary outcomes:
measure: Hair shedding
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
state: Kadıköy
Study officials:
affiliation: Istanbul Medeniyet University
name: Hasan AKSOY, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Asghar F, Shamim N, Farooque U, Sheikh H, Aqeel R. Telogen Effluvium: A Review of the Literature. Cureus. 2020 May 27;12(5):e8320. doi: 10.7759/cureus.8320.
citation: Mieczkowska K, Deutsch A, Borok J, Guzman AK, Fruchter R, Patel P, Wind O, McLellan BN, Mann RE, Halverstam CP. Telogen effluvium: a sequela of COVID-19. Int J Dermatol. 2021 Jan;60(1):122-124. doi: 10.1111/ijd.15313. Epub 2020 Nov 23. No abstract available.
citation: Rizzetto G, Diotallevi F, Campanati A, Radi G, Bianchelli T, Molinelli E, Mazzanti S, Offidani A. Telogen effluvium related to post severe Sars-Cov-2 infection: Clinical aspects and our management experience. Dermatol Ther. 2021 Jan;34(1):e14547. doi: 10.1111/dth.14547. Epub 2020 Nov 23.
citation: Cline A, Kazemi A, Moy J, Safai B, Marmon S. A surge in the incidence of telogen effluvium in minority predominant communities heavily impacted by COVID-19. J Am Acad Dermatol. 2021 Mar;84(3):773-775. doi: 10.1016/j.jaad.2020.11.032. Epub 2020 Dec 10. No abstract available.
Clinical trial NCT05541302: Retrospective TMS Therapy for Adults With MDD
Official title: A Retrospective Registry Study to Evaluate Extended NeuroStar® TMS Therapy for Adults With Major Depressive Disorder (MDD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder (MDD)
Lead sponsor: Neuronetics
Sponsor class: OTHER
Collaborators: name: Southern California TMS Center
name: Brown University
name: TMS of South Tampa
name: Sheppard Pratt Health System
name: Nashville NeuroCare Therapy
name: NAMSA
name: Columbia University
First posted: 2022-09-15
Enrollment: 6456
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises patients who were treated with Extended NeuroStar TMS Therapy for MDD on or after November 8, 2008, and whose treatment information was entered in the Neuronetics TrakStar registry at one of the qualifying participating study sites, and for whom the pre-specified required data elements are available in the TrakStar registry and who satisfy each of the study inclusion criteria and none of the exclusion criteria.

Brief summary: Examine change in the magnitude of antidepressant effects as a function of number of TMS sessions and to determine whether extended treatment courses, beyond 30 and beyond 36 TMS sessions, result in improved efficacy.

Detailed description: The efficacy of TMS in major depressive disorder (MDD) has markedly improved since the pivotal sham-controlled trials. While this enhanced efficacy has been attributed to use of longer treatment courses, the impact of number of treatment sessions on efficacy has not been adequately evaluated. The study device is the Neuronetics, Inc. NeuroStar® TMS Therapy System (K160703, K201158).The study is a retrospective analysis of real-world data from commercial centers. The data will be gathered from the Neuronetics database called TrakStar which collects records of each patient's treatment. The data will be used only as applicable to the objectives of this study.

Eligibility criteria: Inclusion Criteria:

1. Male or female.
2. At least 18 years of age.
3. Treatment with NeuroStar TMS Therapy.
4. Treatment date of November 01, 2008 or later.
5. Patient received at least one treatment with NeuroStar TMS Therapy according to standardized NeuroStar TMS Therapy treatment protocols.
6. Primary diagnosis of Major Depressive Disorder (MDD) with no comorbid diagnosis.
7. PHQ-9 scores available at baseline (pre-treatment).
8. Moderate or greater depression prior to the initial treatment course with NeuroStar TMS Therapy, defined as baseline score on the Physician Health Questionnaire-9 (PHQ- 9) ≥ 10.

Primary outcomes:
measure: Primary Objective
timeFrame: 1 to > 36 sessions for acute treatment sessions or > 6 weeks.
measure: Primary Objective
timeFrame: 1 to > 36 sessions for acute treatment sessions or > 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06243302: Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration
Official title: Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anal Fistula
Keywords: VAAFT
OTSC
diathermy Ablation of Fistula Tract
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females with trans-sphincteric perianal fistulas

Brief summary: This study is expected to recruit 20-25 cases treated with video assisted anal fistula treatment. Additionally the internal opening of the fistulae will be closed by an OTSC clip.

Detailed description: Sphincter damage after anal fistulae surgery is the most important cause of incontinence in adults. Surgeons are gradually gradually getting more reluctant for creating any damage to sphincter for this reason. Anteriorly located, high and trans-sphincteric fistulae are at more risk.

Ablating the fistula tract by laser or diathermy has been in use for a long time. Recently a rigid thin camera to visualize all side tracts and branches for ablating them under direct vision has also been in use especially in Europe. Recently, closing the internal opening after ablating the fistula tract was reported to offer higher success rates for healing with less recurrence. The success rate was higher when the opening was closed by a stapler device.

Our aim in this study is to use o novel technique by using OTSC clip for water tight closure of the internal fistula opening after diathermy ablation of the tract under direct vision and compare the healing and recurrence rates with other methods.

Eligibility criteria: Inclusion Criteria: Patients with trans-sphincteric and inter-sphincteric perianal fistulae

-

Exclusion Criteria:

* Presence of acute abscess, Inflammatory Bowel Disease, Myeloproliferative disease, established incontinence, Recto-vaginal fistula

Primary outcomes:
measure: Fistula healing
timeFrame: January 2024
Secondary outcomes:
measure: Recurrence
timeFrame: January 2024
measure: perianal abscess/fistula
timeFrame: January 2024
Other outcomes:
Locations:
city: Cebeci
country: Turkey
facility: Ankara University Hospital,Dept of Surgery
state: Ankara
Study officials:
References:
citation: Meinero P, Mori L, Gasloli G. Video-assisted anal fistula treatment: a new concept of treating anal fistulas. Dis Colon Rectum. 2014 Mar;57(3):354-9. doi: 10.1097/DCR.0000000000000082.
Clinical trial NCT04749602: Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.
Official title: A Phase II Trial of Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Cancer Metastatic
Non-small Cell Lung Cancer Metastatic
Pleural Effusion, Malignant
Keywords: Nivolumab
Intrapleural irrigation
Pleural carcinomatosis
Lead sponsor: Kidney Cancer Research Bureau
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort 1 (renal cell carcinoma / lung cancer) Cohort 2 (lung cancer)
Primary purpose: TREATMENT

Brief summary: Patients with advanced cancers who have pleural effusion, especially those requiring pleural evacuation, experienced poorer survival when treated with immunotherapy. The pleura also acts as a natural barrier that can limit the penetration of immune checkpoint inhibitors. In this multicenter phase 2 study, the preliminary efficacy and toxicity of intrapleural instillation of the nivolumab in patients with immune-sensitive metastatic cancers will be accessed.

Detailed description: Patients ≥18 years old who have large volume of pleural effusion, required evacuation, and received systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor) for metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC) will be eligible. Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years old
* Large volume of pleural effusion (1 liter and more), required evacuation
* Systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor)
* Metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC)

Exclusion Criteria:

* Autoimmune disorders
* Previous treatment for

Primary outcomes:
measure: 3-month recurrence-free survival
timeFrame: 3 months
Secondary outcomes:
measure: Rate of any grade adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University
city: Moscow
country: Russian Federation
facility: Kidney Cancer Research Bureau
city: Moscow
country: Russian Federation
facility: Medicine 24/7 clinic
city: Moscow
country: Russian Federation
facility: Medscan
city: Moscow
country: Russian Federation
facility: Yauza clinical hospital
Study officials:
affiliation: Kidney Cancer Research Bureau
name: Ilya Tsimafeyeu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02945202: Influence of Trabeculectomy and Phaco-trabeculectomy on Corneal Astigmatism
Official title: Einfluss Der Trabekulektomie Und Der Kombinierten Phako-Trabekulektomie Auf Den Kornealen Astigmatismus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Astigmatism
Glaucoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 150
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: This study investigates the effects of trabeculectomy and combined phacoemulsification plus trabeculectomy on corneal astigmatism.

Detailed description: Prospectively, consecutive patients at the University Hospital of Zurich undergoing either trabeculectomy (trab) or phaco-trabeculectomy (phaco-trab) are included in this study between January and December 2017. The study interventions takes place 6 months after surgery and include examination of refraction, biometry and corneal topography in order to assess the patient's astigmatism. The values are compared to the preoperative baseline values, which are available from patient records.

Eligibility criteria: Inclusion Criteria:

* Trabeculectomy or Phaco-Trabeculectomy between 01/2017 and 12/2017
* Age ≥18 years

Exclusion Criteria:

* Acute or chronic corneal diseases

Primary outcomes:
measure: Difference in Astigmatism [Diopters (dpt)]
timeFrame: preoperative astigmatism compared to 6 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04206202: 3D Printing Guides in Total Knee Arthroplasty
Official title: Application of 3D Printing Patient-specific Instrumentation in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis of the Knee
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study aims to design a patient-specific instrumentation to be used in total knee arthroplasty and evaluate its accuracy of femoral component rotation and intramedullary guide so as to explore its clinical effects.

Detailed description: Total knee arthroplasty (TKA) is the most universal and effective means for treating terminal stage osteoarthritis (OA) of knee. With the development of three-dimensional printing (3DP) technology in the medical domain, the application of patient-specific instrumentation (PSI) in arthroplasty has become more common. The aim of this study was to design a PSI to achieve appropriate femoral resection and accurate component rotation for a successful TKA, and to explore its clinical effects.

Eligibility criteria: Inclusion Criteria:

* Patients with advanced OA of the knee, varus deformity of no more than 15 degrees, flexion-contracture deformity of no more than 10 degrees, without extra-articular deformity of the knee;
* Weight-bearing radiograph of the X-ray image showed the OA Kellgren-Lawrence classification grade Ⅳ;
* The treatment for the patient was TKA, whether or not to use PSI depends on the actual grouping.

Exclusion Criteria:

* Patients with varus deformity of more than 15 degrees, flexion-contracture deformity of more than 10 degrees of the knee;
* Patients with traumatic arthritis and inflammatory arthritis;
* Patients with huge bone defects around the knee
* Patients who had active infection around the knee;
* Patients with knee valgus deformity;
* Patients with severe extra-articular deformity;
* Patients who had previous knee surgery;
* Patients who had periarticular soft tissue dysfunction and neuropathy;
* Patients who had poor physical condition and could not withstand the operation;
* Patients who refused to be followed.

Primary outcomes:
measure: Change of the radiological outcomes
timeFrame: Postoperative 12 months
Secondary outcomes:
measure: Hospital for Special Surgery knee score (HSS)
timeFrame: Postoperative 1,6,12 months
measure: American Knee Society knee score (AKS)
timeFrame: Postoperative 1,6,12 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
Study officials:
affiliation: Southwest Hospital, China
name: Rui He, M.D.
role: PRINCIPAL_INVESTIGATOR
References: