louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04361448: Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR
Official title: Comparison of the Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Covid-19
SARS-CoV-2
Diagnosis
Polymerase Chain Reaction
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Beside the regular sampling method of 1 nasopharyngeal swab, 2 extra swabs will be taken in each volunteer. Performance of the 3 methods for laboratory diagnosis by PCR of Covid-19 will be compared.
Primary purpose: DIAGNOSTIC

Brief summary: The performance of 3 different sampling methods (2 nasopharyngeal swabs, 1 oropharyngeal swab) for the detection of SARS-CoV-2 with real-time reverse transcriptase polymerase chain reaction will be compared.

Detailed description: Thirty volunteers will be recruited from health care workers suspicious for Covid-19, who consult the ocupational physician for Covid-19 testing.

For each volunteer, 3 swabs will be taken:

* Flocked eSwab (Copan, Italy) of the oropharynx
* Flocked nasopharyngeal eSwab (Copan, Italy) of the nasopharynx
* Dry flocked nasopharyngeal Swab, placed in lysis buffer Each swab will be tested for the presence of SARS-CoV-2 with an in-house reverse-transcriptase real-time PCR (Egene).

Performance of each method will be calculated.

Eligibility criteria: Inclusion Criteria:

* health care workers with symptoms suspicious for Covid-19

Exclusion Criteria:

* none

Primary outcomes:
measure: sensitivity
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
Study officials:
affiliation: Jessa Hospital, Hasselt, Belgium
name: Reinoud Cartuyvels
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00592748: Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
Official title: Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chordoma
Chondrosarcoma
Keywords: charged particle radiation therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine if the administration of a higher dose would decrease the chance of tumor recurrence, compared to the risk of tumor recurrence with a lower dose. Most of the treatment will be given protons, but participants may receive a small portion of treatment with x-rays, because less radiation is given to the skin with x-rays. This study uses two slightly different doses of radiation It is not clear at this time which of the dose levels is better.

Detailed description: * Participants will be assigned to a dose level by random chance, like flipping a coin.
* A treatment plan will be determined by a treatment planning CT scan and will either involve 40-44 treatments or 37-40 treatments.

Eligibility criteria: Inclusion Criteria:

* Biopsy proven chordoma. Slides must be reviewed prior to randomization by the central review pathologist
* Sites: Intercranial (sphenoid, clivus, petrous, basio-occiput) or cervical spine
* Boost target volume less than or equal to 150
* 18 years of age or older
* Karnofsky Performance Status \> 50
* Neurologic Function of I or II
* No evidence of metastases

Exclusion Criteria:

* Previous radiation to the head or neck that would compromise the ability to deliver the prescribed treatment
* Concurrent or prior malignancy unless disease free for 5 or more years
* Evidence of metastatic disease
* Diabetes mellitus
* Major medical illness or psychiatric impairments that in the opinion of the investigator, will prevent administration or completion of the protocol therapy

Primary outcomes:
measure: Acute Toxicity
timeFrame: 90 days
Secondary outcomes:
measure: Establish local control rates for both dose schedules.
timeFrame: 5 years
measure: To provide date to be used as the basis for choosing the dose of charged particle radiation for chordomas of the base of skull and the cervical spine.
timeFrame: 5 years
measure: Late Toxicity
timeFrame: 5 Years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Norbert J. Liebsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454648: Prehospital Traumatic Brain Injury
Official title: Severe Traumatic Brain Injury - Comparison of Outcome in Paramedic Versus Physician Staffed Emergency Medical Services
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
EMS
Out-of-Hospital
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 458
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The aim of the study is to measure the effect of Finnish physician-staffed EMS unit treatment methods on traumatic brain injury (TBI) patient prognosis.

Detailed description: A secondary aim is to identify out-of-hospital treatment factors that can be influenced by education and protocols.

Eligibility criteria: Inclusion Criteria:

* TBI with GCS ≤ 8 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital.

Exclusion Criteria:

* Multiple trauma

Primary outcomes:
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Glasgow outcome score
timeFrame: 1 year
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Arvi Yli-Hankala, professor
role: STUDY_DIRECTOR
affiliation: Tampere University
name: Toni Pakkanen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Ilkka Virkkunen, M.D., PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Tom Silfvast, M.D., PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Tarja Randell, M.D., PhD
role: STUDY_CHAIR
References:
citation: Pakkanen T, Virkkunen I, Kamarainen A, Huhtala H, Silfvast T, Virta J, Randell T, Yli-Hankala A. Pre-hospital severe traumatic brain injury - comparison of outcome in paramedic versus physician staffed emergency medical services. Scand J Trauma Resusc Emerg Med. 2016 Apr 29;24:62. doi: 10.1186/s13049-016-0256-x.
Clinical trial NCT00261248: Vaccine for Recurrent Urinary Tract Infections in Women
Official title: Phase 2 Clinical Trial of Vaginal Mucosal Immunization for Recurrent Urinary Tract Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Urinary Tract Infections in Women
Keywords: Phase 2
Vaccine
Urinary Tract Infection
Vaginal Mucosal
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-12-02
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is determine whether a vaginal mucosal vaccine given to women with a history of recurrent urinary tract infections can reduce the number of infections occurring in a six-month study period, as compared to placebo treatment.

Detailed description: Recurrent urinary tract infections (UTIs) affect approximately 10% of women in the United States. Since antibiotic prophylaxis is not always effective, alternate treatments need to be developed. One such treatment would be immunization with a vaccine containing bacteria known to cause these infections. The objective of the study is to immunize susceptible women with inactivated bacteria contained in a vaginal suppository and to monitor the rates of reinfection compared to a group of women treated with placebo suppositories. Each group of patients will receive a total of six suppositories in the first four-months of the six-month study during which all UTIs and side effects will be recorded. The infection rates between vaccine- and placebo-treated women will be statistically analyzed to determine vaccine efficacy.

Eligibility criteria: Inclusion Criteria:

* Three or more urinary tract infections in the previous year

Exclusion Criteria:

* Neurogenic bladder
* Interstitial cystitis
* Urinary diversion
* Kidney stones
* Indwelling catheter

Primary outcomes:
measure: Rate of re-infection over the study
Secondary outcomes:
measure: Infection-free status at completion of study
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David T Uehling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uehling DT, Hopkins WJ, Beierle LM, Kryger JV, Heisey DM. Vaginal mucosal immunization for recurrent urinary tract infection: extended phase II clinical trial. J Infect Dis. 2001 Mar 1;183 Suppl 1:S81-3. doi: 10.1086/318839. No abstract available.
Clinical trial NCT04039048: Effect of ctDCS During Balance Training on Cerebellar Ataxia
Official title: Effects of Cerebellar Transcranial Direct Current Stimulation During Balance Training on Cerebellar Ataxia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebellar Ataxia
Cerebellum; Injury
Balance
Keywords: Biodex balance system
Posture control
Ataxia' severity
ctDCS
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Cerebellar ataxia is a neurologic symptom caused by damage or dysfunction in the cerebellum and its pathways that results in loss of coordination, balance and postural control. There is a high rate (93%) of fallings for this population that could limit daily life activities. Pharmacological interventions are not able to modify the balance, therefore, new approaches to rehabilitate must be studied. ctDCS is a non-invasive brain stimulation that seems to be a new and innovator technique to restore ataxia symptoms. The purpose of this study is to evaluate the effects of ctDCS associated with balance training on cerebellar ataxia patients. A counterbalanced crossover, sham-controlled, triple blind trial will be performed. All subjects will receive the real and sham ctDCS associated to balance training. The anodal ctDCS (2 mA, 20 minutes) or sham (2mA, 30 seconds) will be applied during balance training at Biodex Balance System (BBS). The balance will be the primary outcome and will be evaluated through Posture Control at Biodex Balance System. Ataxia' severity and functional mobility will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA) and 10 meters walking test, respectively.


Eligibility criteria: Inclusion Criteria:

* Cerebellar ataxia
* Score \> 1 ≤ 4 on posture of Scale for assessment and rating of ataxia

Exclusion Criteria:

* Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests;
* Pacemaker;
* History of seizures;
* Metallic implants in the head or neck;
* Medication change (3 months) during the period of study

Primary outcomes:
measure: Change in balance
timeFrame: 5 minutes before the intervention and 10 minutes after the intervention
Secondary outcomes:
measure: Change in Ataxia' severity
timeFrame: 10 minutes before the intervention and 15 minutes after the intervention
measure: Change in functional mobility
timeFrame: 15 minutes before the intervention and 20 minutes after the intervention
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Kátia Monte-Silva
state: Pernambuco
Study officials:
References:
Clinical trial NCT06620848: A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in the Treatment of Advanced Biliary Tract Tumors.
Official title: A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in Patients With Advanced Biliary Tract Tumors.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Biliary Tract Cancer
Keywords: KRAS G12D
Biliary Tract Cancer
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was designed to evaluate the efficacy and safety of HRS-4642 monotherapy or in combination with adebrelimab in the treatment of advanced biliary tract tumor patients.


Eligibility criteria: Inclusion Criteria:

1. 18-75 years old, male or female.
2. Histologically or cytologically confirmed diagnosis of advanced biliary tract cancer.
3. Unresectable or metastatic advanced patients with progression or intolerance for ≥ one line of systemic therapy, including patients who metastasize during or within 6 months after neoadjuvant or adjuvant therapy (adjuvant therapy or neoadjuvant therapy must include gemcitabine-based chemotherapy).
4. Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
5. ECOG performance status of 0-1.
6. With a life expectancy of ≥3 months.
7. Have adequate laboratory parameters and organ functions during the screening period.

Exclusion Criteria:

1. Known history of hypersensitivity to any components of HRS-4642 or adebrelimab.
2. Prior anti-tumor chemotherapy within 4 weeks before the study drug administration. Small molecular targeted drugs (including oral targeted drugs for other clinical trials) with a half-life of less than 5 or 7 days from the first medication.
3. Patients with untreated or active central nervous system tumor metastasis.
4. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.

Primary outcomes:
measure: Objective response rate (ORR) by RECIST V1.1
timeFrame: up 2 years
measure: Adverse events(AEs), serious adverse events（SAEs）
timeFrame: up 2 years
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: up 2 years
measure: Progression-free survival (PFS)
timeFrame: up 2 years
measure: Overall survival (OS)
timeFrame: up 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jia Fan, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Zhongshan Hospital
name: Guoming Shi, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00324948: Topical Alprostadil for Female Sexual Arousal Disorder
Official title: A Double-Blind, Randomized, 6-Month Evaluation of the Safety and Efficacy of Topical Alprostadil in Hysterectomized Women With Female Sexual Arousal Disorder (FSAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sexual Dysfunction, Physiological
Keywords: Female sexual arousal disorder
Female sexual dysfunction
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2006-05-11
Enrollment: 300
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 300 patients with female sexual arousal disorder who meet eligibility criteria will be enrolled and randomized to receive either active drug or matching placebo. After a two-month, non-treatment period, patients will receive study drug for 6 months and will record information about sexual encounters in a daily diary. Study drug will be applied directly to the genital area 30-60 minutes before initiation of sexual activity. The endpoint of the study is based on the use of a standard measure of sexual function (FSEP).

Detailed description: This is a multicenter, double-blind, randomized, placebo-controlled, parallel-design study involving about 300 women who are 21-60 years of age inclusive, who have undergone a hysterectomy (with or without oophorectomy), and who have a primary diagnosis of FSAD. The diagnosis of FSAD will be made based on a medical and sexual history and confirmed using a structured interview by trained personnel. Study subjects will undergo a 2-month non-treatment run-in period followed by a 6-month period of blinded study therapy. Study drug is applied topically to the genitalia 30-60 minutes prior to initiation of sexual activity. Study subjects will complete several questionnaires at various times during the study and will complete a daily diary. The study endpoint is based on the FSEP and other standard questionnaires, as well as safety and tolerability of study drug.

Eligibility criteria: Inclusion Criteria:

* Women aged 21-60 who have undergone a hysterectomy
* Have a primary diagnosis of female sexual arousal disorder
* Be willing to comply with all study requirements and visit schedules

Exclusion Criteria:

* Known allergy to alprostadil or product excipients
* Have a genital inflammatory or infectious condition or STD
* Have a significant medical condition that would interfere with the study
* Have received an investigational drug within the prior 30 days

Primary outcomes:
measure: FSEP
Secondary outcomes:
measure: FSFI
measure: Global assessment
measure: Adverse events
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine-Dept of OB/GYN
state: California
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
Study officials:
affiliation: Vivus Clinical Research Department
name: Sam Teichman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05508048: The Effects of Logotherapy Based Psychosocial Support Program on Nursing Students on the Meaning of Life and Life Satisfaction
Official title: The Effects of Existential Approach and Logotherapy Based Psychosocial Support Program on Nursing Students in Period of Pandemic on the Meaning of Life and Life Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meaning of Life and Life Satisfaction
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a psychosocial intervention program designed to intervene in the meaning of life and existential problems and life satisfaction in nursing students, especially during the epidemic. In the short term, it expects that students will gain awareness, especially in areas such as life satisfaction, anxiety, aimlessness, the meaning of life, deterioration in functionality, and in the long term, the individual's ultimate issues (death, loneliness, meaning and responsibility) and provide a perspective that can cope with the problems that may arise in these areas. Based on all these, it is aimed to raise awareness of the meaning of life and life satisfaction in nursing students, who constitute a young population, with the existential approach and logotherapy-based psychosocial support program.

H1. The existential approach and logotherapy-based psychosocial support program will affect the experimental group's meaning and purpose of life scale scores.

H2. The existential approach and logotherapy-based psychosocial support program will affect the experimental group's life satisfaction scale scores.

H3. After the existential approach and logotherapy-based psychosocial support program, there will be a significant difference between the experimental and control groups' meaning and purpose of life scores.

H4. After the existential approach and logotherapy-based psychosocial support program, there will be a significant difference between the experimental and control groups' life satisfaction scores.


Eligibility criteria: Inclusion Criteria:

* Completed mental health and psychiatric nursing course
* Agreeing to participate as a result of the research announcement
* No acute psychiatric problem
* Those who have not lost their first-degree relative due to Covid-19

Exclusion Criteria:

* Having an acute psychiatric problem
* Those who lost their first-degree relative due to Covid-19

Primary outcomes:
measure: Group Difference-Meaning and Purpose
timeFrame: 10 weeks
measure: Between Groups Difference-Life Satisfaction
timeFrame: 10 weeks
measure: In Group Difference-Life Satisfaction
timeFrame: 10 weeks
measure: In Group Difference-Meaning and Purpose
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Üniversitesi-Cerrahpaşa
Study officials:
References:
Clinical trial NCT00798148: 131I-MIBG With Myeloablative Chemotherapy and Autologous Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma
Official title: Evaluation of Benefit and Side Effects of 131I-MIBG in Combination With Myeloablative Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Neuroblastoma
Keywords: Neuroblastoma
MIBG
Autologous Peripheral Stem Cell Transplantation
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is studying how well iodine I 131 metaiodobenzylguanidine together with combination chemotherapy works in treating patients who are undergoing an autologous peripheral stem cell for high risk or relapsed neuroblastoma.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed Neuroblastoma and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites
* High risk according COG (Children Oncology Group)OR Relapse OR Refractory
* As at least one I131-MIBG avid target lesion determined by diagnostic MIBG scan
* Glomerular filtration rate or creatinine clearance \> 60 ml/min
* No tumor cell in Bone Marrow by routine morphology aspiration and biopsy before peripheral stem cell collection
* No active infection

Exclusion Criteria:

* Impaired renal function
* No avid I131-MIBG lesion
* Active infection

Primary outcomes:
measure: Response (complete response, very good partial response, and partial response) at one-years post stem cell transplantation
timeFrame: one-years post stem cell transplantation
Secondary outcomes:
measure: Overall survival
timeFrame: one-year after stem cell tranplantation
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hematology-Oncology & SCT Research Center
city: Tehran
country: Iran, Islamic Republic of
facility: Research Institute for Nuclear Medicine
Study officials:
References: