louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05060939: SARS-CoV-2 Infection in COVID-19 Vaccinated Patients
Official title: Characterization of the Viral Genome and Humoral Immune Response in COVID-19 Vaccinated Patients With SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: SARS-CoV-2, COVID-19
vaccine,
variant
host-immune response
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 1072
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Vaccination of the population is crucial in the fight against the COVID-19 pandemic. Although most available vaccines have an estimated efficacy against symptomatic infection of 65-95%, this can be significantly reduced if the patient has co-morbidities such as immunosuppression or if the full vaccination schedule is not followed. Infection with SARS-CoV-2 variants, carrying mutations, notably on the spike protein, may also be associated with escape from immunity acquired by vaccination. Indeed, in vitro studies have shown a decrease in sensitivity to neutralizing antibodies acquired after vaccination or even after infection for certain variants such as variant B.1.351 (beta variant according to the WHO, first detection in South Africa) or variant B.1.617.2. (delta variant according to the WHO, first detection in India). On the other hand, cases of COVID-19 following a full vaccination regimen have recently been reported. With the increasing detection of new variants and in the context of increasing vaccination coverage of the population, one of the priority missions of the National Reference Centre (NRC) for respiratory infection viruses is to clinically and virologically investigate all cases of infection in vaccinated patients. The main objective is to determine whether a particular variant is over-represented in vaccinated patients with an infection. The secondary objective is to study the humoral immune response in COVID-19 vaccinated patients with and without SARS-CoV-2 infection.


Eligibility criteria: Inclusion Criteria:

* Age: ≥ 18 years old
* Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months.
* Persons affiliated to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

- Pregnant or lactating woman

Primary outcomes:
measure: Distribution of the clade and lineage of SARS-CoV-2 in vaccinated patients
timeFrame: At inclusion
Secondary outcomes:
measure: Titers of SARS-CoV-2 antibodies
timeFrame: At inclusion
measure: Titers of SARS-CoV-2 antibodies
timeFrame: At inclusion
measure: Titers of SARS-CoV-2 antibodies
timeFrame: At inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: BAL Antonin
state: National Reference Center For Respiratory Viruses
Study officials:
References:
Clinical trial NCT01732939: Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Hospital Affiliated to Military Medical Science, Beijing
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: diaganosis of invasive breast cancer, tumor size \> 2.0cm by MRI or ultrasound or clinical examination.

Brief summary: The study purpose is to observe which neoadjuvant chemotherapy regimens is the better for invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines plus taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.

Detailed description: The investigators hope to get preliminary results for the breast cancer patients who are given different neoadjuvant chemothetapy regimens. The patients are randomized two chemotherapy regimens. One is anthracyclines plus taxanes for 6-8 cycles,the other is anthracyclines plus taxanes for 3-4 cycles ,then switch tovinorelbine plus cisplatinum for 3-4 cycles.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of invasive ductal or lobular breast cancer.
* Previously untreated (no chemotherapy or hormonal therapy or radiation therapy) invasive breast cancer.
* no anti-Her2 therapy if HER2 positive ( defined as 3+ IHC or FISH positive)
* Performance Status ECOG \<2
* Age \> 18 years
* Tumor \> 2.0 cm by MRI and/or sonographic or clinical exam measurements.or Karnofsky \>50%
* Lab test :

  * Absolute neutrophil count \> 1,500/mm3

    * Total Bilirubin ≤ 2×ULN
    * AST and ALT ≤ 2.5×ULN
  * serum creatinine ≤ 1.5×ULN

Exclusion Criteria:

* Pregnant or breast feeding patients are excluded
* stage Ⅳ breast cancer
* History of non-breast malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon,melanoma in situ, and basal cell and squamous cell carcinomas of the skin
* uncontrolled cardiac disease
* Active infection or chronic infection requiring chronic suppressive antibiotics
* History of hypersensitivity reaction to investigating drugs

Primary outcomes:
measure: pathological complete response rate
timeFrame: one year
Secondary outcomes:
measure: clinical response rate, safety
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hospital affiliated academy military medical science
state: Beijing
Study officials:
affiliation: Hospital Affiliated Military Medical Science
name: Zefei Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03801239: Reliability of Polish-Version Overactive Bladder Syndrom Scores (OABSS)
Official title: Reliability of Polish-Version Overactive Bladder Syndrom Scores (OABSS) Questionnaire and the Correlation of OABSS With the Results of UDI-6 and IIQ-7 Questionnaires
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Urinary Incontinence
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 822
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients were recruited from women attending the Outpatient Clinic of the 2nd Gynecology Department of the Medical University in Lublin. SUI was observed in 290 cases; OAB in 283 patients and 249 had MUI

Brief summary: The aim of this study was to develop and assess the effectiveness of a Polish version of OABSS and to correlate the OABSS with urodynamic study results and UDI-6, IIQ-7 questionnaires

Detailed description: The translation into Polish followed standardized procedures. Women aged between 18-75 years were included into the study. All patients were recruited from women attending the Outpatient Clinic of the 2nd Gynecology Department of the Medical University in Lublin. SUI was observed in 290 cases; OAB in 283 patients and 249 had MUI (confirmed by medical history, and urodynamic investigation). All patients completed the Polish version of the OABSS on two separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.

Eligibility criteria: Inclusion Criteria:

* confirmed Urinary Incontinence in Urodynamic study (SUI, OAB, MUI)
* female aged 18-75 years old

Exclusion Criteria:

* malignant disorders
* uncontrolled diabetes
* inability to understand informed consent

Primary outcomes:
measure: Correlation of OABSS questionnaire and Urodynamic study
timeFrame: 2 weeks
Secondary outcomes:
measure: Correlation of OABSS questionnaire with UDI-6 results
timeFrame: 2 weeks
measure: Correlation of OABSS questionnaire with IIQ-7 results
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: Medical University of Lublin
state: Lubelskie
Study officials:
References:
Clinical trial NCT03273439: A Study of rTMS for Cognitive Deficits in Chronic Patients With Schizophrenia
Official title: A Randomized, Double-blind Study of Repetitive Transcranial Magnetic Stimulation for Cognitive Deficits in Chronic Patients With Schizophrenia in a Chinese Han Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Repetitive transcranial magnetic stimulation
Negative symptoms
randomized controlled trial
Schizophrenia
cognition
Lead sponsor: Suzhou Psychiatric Hospital
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.
Primary purpose: TREATMENT

Brief summary: In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.

Detailed description: This is a randomized, sham-controlled, double-blinded trial. 47 patients diagnosed with schizophrenia on stable antipsychotic treatment were randomly assigned to active rTMS treatment group (n=25) or a sham rTMS treatment group (n=22). 25 patients in the active rTMS group received 10 Hz 110% rTMS, while 22 patients were subjected to sham rTMS, both being given 4-week treatment (5 days per week). Efficacy of negative symptom was assessed with the Scale for the Assessment of Negative Symptoms (SANS), the Positive and Negative symptom scale (PANSS) at baseline, the end of 4 weeks and 8 weeks. The cognitive function was assessed with CANTAB at baseline, the end of 4 weeks and 8 weeks .The side effects were assessed with Treatment Emergent Symptoms Scale at baseline and the end of 4 weeks.

Eligibility criteria: Inclusion Criteria:

1. Right-handed;
2. meeting the diagnosis of schizophrenia for at least 2 years;
3. had been on anti-psychotic medications for more than 12 weeks;
4. with unresolved negative symptoms (SANS\>20).

Exclusion Criteria:

1. with substance use disorders ;
2. with cerebral pathologies (e.g. seizure, aneurysm, stroke), intra-cranial metals, pacemakers, severe cardiovascular diseases;
3. receiving electroconvulsive therapy in the past 3 months.

Primary outcomes:
measure: Scale for the Assessment of Negative Symptoms (SANS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Positive and Negative symptom scale (PANSS)
timeFrame: 4 weeks
measure: CANTAB
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Suzhou Guangji Hospital
name: Guangzhong Yin, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00400439: A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
Official title: A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Heart Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-11-16
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.


Eligibility criteria: Inclusion Criteria:

* patients who have completed treatment on study NC19453.

Exclusion Criteria:

* any significant lymph node abnormalities at the end of study NC19453.

Primary outcomes:
measure: Percent Change From Baseline in HDL-C
timeFrame: Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))
Secondary outcomes:
measure: Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)
timeFrame: Baseline and Week 24 (Week 48 from start of NC19453)
Other outcomes:
Locations:
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Louisville
country: United States
state: Kentucky
city: Bethesda
country: United States
state: Maryland
city: Minneapolis
country: United States
state: Minnesota
city: Statesville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02321839: Evaluation of the Usefulness of a Treat and Extend Regimen Using Ranibizumab for Neovascular AMD.
Official title: Evaluation of the Usefulness of a Treat and Extend Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neovascular Age-related Macular Degeneration
Keywords: neovascular age-related macular degeneration
Ranibizumab
Treat and extend
Lead sponsor: Nagoya City University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2014-12-22
Enrollment: 78
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the visual outcome, number of injections and visits, and the effect of mental status of a treat and extend regimen in managing neovascular age-related macular degeneration with intravitreal ranibizumab.

Detailed description: Treat and Extend Regimen (TER) may contribute to the improvement to a patients' mentality, since the treatment intervals are extended if there were no signs of recurrence. Therefore, we have planned to examine the psychological impact of TER using Hospital Anxiety and Depression Scale (HADS), in addition to the improvement of visual acuity and central retinal thickness.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent form
* Male or female of aged 50 years or older
* Typical AMD and PCV patients
* BCVA of 24 letters or over

Exclusion Criteria:

* Total lesion area of \>12 DA or \>30.5 mm2
* The existence of subretinal hemorrhage area constituting ≥50% of total lesion area
* The existence of scar or fibrosis area constituting ≥50% of total lesion area
* The existence of RPE tear
* Prior treatment for wet AMD
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
* The pregnant or lactating woman

Primary outcomes:
measure: Visual acuity
timeFrame: One Year
Secondary outcomes:
measure: central foveal thickness
timeFrame: One and two years
Other outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: one and two years
Locations:
city: Nagoya
country: Japan
facility: Sugita Eye Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City Univsersity
state: Aichi
Study officials:
affiliation: Nagoya City Univsersity
name: Yuichiro Ogura
role: STUDY_CHAIR
References:
citation: Kato A, Yasukawa T, Sugita I, Yoshida M, Nozaki M, Hirano Y, Kondo J, Abe T, Sugita K, Okita T, Morita H, Takase N, Ogura Y. Mental Status and Feasibility of an Intravitreal Ranibizumab Treat-and-Extend Regimen in Patients with Neovascular Age-Related Macular Degeneration. Adv Ther. 2022 Mar;39(3):1403-1416. doi: 10.1007/s12325-022-02052-1. Epub 2022 Feb 3.
Clinical trial NCT01228539: Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study
Official title: Breaking the Cycle IV: Military PTSD (MPTSD) Treatment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Anger
Aggression
Keywords: PTSD
Anger
Aggression
Military
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2010-10-26
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare the efficacy of Trauma Affect Regulation: Guide for Education and Therapy (TARGET) vs. the best validated psychotherapy for adults with posttraumatic stress disorder (PTSD), Prolonged Exposure (PE). Male military personnel and veterans suffering with PTSD and problems with anger after returning from military service in Afghanistan (Operation Emerging Freedom, OEF) and/or Iraq (Operation Iraqi Freedom, OIF) will be participants. The goal is to determine if a present-centered psychotherapy that teaches skills for emotion regulation and does not require re-telling of traumatic memories is as efficacious as the trauma memory-focused PE psychotherapy.

Detailed description: The study is based on a theoretical and clinical model that involves a series of associated risks that are set in motion by exposure to military-related traumatic stressors in Iraq or Afghanistan. Trauma exposure places personnel at risk for PTSD, which in turn increases their risk of problems with anger and hostility, emotion dysregulation and experiential avoidance, and ultimately with alcohol abuse and aggression. The two types of treatments being compared, TARGET (Trauma Affect Regulation: Guide for Education and Therapy) and PE (Prolonged Exposure), are both designed to directly reduce PTSD severity by reducing emotion dysregulation (TARGET) and experiential avoidance (PE), and therefore are hypothesized to reduce the risk and severity of alcohol abuse and aggression- and thereby to reduce associated legal and societal costs.

Eligibility criteria: Inclusion Criteria:

* be a returning OEF/OIF military personnel or veteran
* have experienced PTSD for the past month
* have experienced anger and at least one act of aggression in the last month
* be mentally able to provide a valid consent

Exclusion Criteria:

* currently be danger of suicide
* currently abusing alcohol or other substances
* been in an inpatient psychiatric or addiction treatment program in the past month

Primary outcomes:
measure: Severity of PTSD symptoms
timeFrame: Post-therapy
Secondary outcomes:
measure: Anger/aggression problems
timeFrame: Post-therapy
measure: Emotion Regulation
timeFrame: Post-therapy
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Julian Ford, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03216239: SIBO & SIFO After Colectomy
Official title: Does Colectomy Predispose to Small Intestinal Bacterial (SIBO) and Fungal Overgrowth (SIFO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Intestinal Bacterial Overgrowth
Small Intestinal Fungal Overgrowth
Colectomy
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients of the Digestive Health Center over a 4 year period who have been seen by the motility specialists for unexplained gastrointestinal symptoms.

Brief summary: After subtotal colectomy, 40% of patients report abdominal pain, gas and diarrhea, and poor quality of life; whose etiology is unknown. The investigators determined whether small intestinal bacterial (SIBO or fungal overgrowth SIFO) could cause these sympotoms (\> 1 year).


Eligibility criteria: Inclusion Criteria:

patients who were referred to a specialist motility center over 4 year period with:

* Unexplained gastrointestinal symptoms such as gas, bloating, belching, diarrhea, and abdominal discomfort
* history of colectomy
* patients with no history of colectomy
* patients included who had normal: upper endoscopy, colonoscopy, computerized abdominal tomography scan, and normal hematology, biochemical profiles, tissue transglutaminase antibody, thyroid stimulating hormone, and normal right upper quadrant ultrasound scan.
* patients with glucose breath test and/or duodenal aspirate

Exclusion Criteria:

* patients with upper gut or small bowel surgery
* Patients who were hospitalized or with serious cardiac or pulmonary or neurologic comorbidities
* Patients with intestinal strictures or known intestinal motility disorders such as scleroderma or pseudo-obstruction syndrome

Primary outcomes:
measure: Prevalence of SIBO/SIFO
timeFrame: 4-5 years
Secondary outcomes:
measure: Response to treatment with antibiotics and antifungals
timeFrame: 4-5 years
Other outcomes:
Locations:
Study officials:
References: