louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04295863: Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
Official title: A Randomized Study Investigating the Pharmacokinetics of Standard Interval Dosing Compared to Extended Interval Dosing of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Metastatic Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 264
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: A randomized research study of drugs nivolumab and pembrolizumab in patients with locally advanced or metastatic cancers. Based on data from earlier studies it appears that the drugs can be given less often then the currently approved schedule. This trial will compare drug levels from the blood from standard interval dosing levels versus taking the drugs less often.


Eligibility criteria: Inclusion Criteria:

* Patients with locally advandced or metastatic cancer whose physician has determined they are candidates for treatment with nivolumab or pembrolizumab
* 18 years old or older
* Measurable disease per RECIST criteria

Exclusion Criteria:

* Patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy.
* Patients whose treatment plan is to receive ipilimumab or other anti-CTLA4 monoclonal antibody in combination with either nivolumab or pembrolizumab.

  * Ipilimumab and nivolumab combination are not eligible for this trial.
  * (Note: Patients whose planned treatment is the combination of anti-PD-1 and tyrosine kinase inhibitor such as pembrolizumab-axitinib or the combination of traditional cytotoxic chemotherapy and anti-PD-1 are eligible)

Primary outcomes:
measure: Noninferiority margin of extended interval dosing compared to standard dosing
timeFrame: 2 years
Secondary outcomes:
measure: Compare the efficacy of extended interval and standard interval dosing
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University Of Chicago Medicine Comprehensive Cancer Center
state: Illinois
city: Madison
country: United States
facility: SSM Health Cancer Care
state: Wisconsin
Study officials:
affiliation: University of Chicago
name: Mark Ratain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02417363: Study on the Relationship Between Periodontitis and Renal Disease
Official title: Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Keywords: biomarkers
renal disease
periodontitis
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 individuals are recruited for each group, the factors of age and gender are matched while selecting the incruited indiduals,all participants were in general good health(except renal disease) and non-smoking.

Brief summary: Analysis of inflammatory markers in periodontitis and patients with early and middle stage renal disease.

Detailed description: A total of 200 population is recruited, individuals are divided into four groups according to a periodontal examination and a general physical examination: healthy individuals ,periodontitis, renal disease patients with healthy periodontium, and renal disease patients wth peridontitis. Fasting blood samples and gingival crevicular fluid are collected from all individuals, and inflammatory markers are analysed for the four groups.

Eligibility criteria: Inclusion Criteria:

* all participants were in general good health(except renal disease) and non-smoking

Exclusion Criteria:

* less than 20 teeth in the dentin
* hypertension
* the presence of systemic disease (e.g., diabetes mellitus ,coronary heart disease, liver, or lung disease)
* a history or the symptom of any other acute or chronic infections
* systemic antibiotic treatment within previous 4 weeks
* periodontal treatment within1 month

Primary outcomes:
measure: Inflammatory markers analysis of the four groups
timeFrame: 3 months after sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
name: Hui Chen
role: STUDY_DIRECTOR
References:
Clinical trial NCT00547235: Emergency Use of Adoptive Immunotherapy With CMV-Specific T Cells After Donor Bone Marrow Transplant of an Infant With Immunodeficiency Syndrome and CMV Infection
Official title: Protocol For The Emergency Use Of Adoptive Immunotherapy With CMV-Specific T Cells Following HLA-Matched Unrelated Donor Bone Marrow Transplant Of An Infant With ADA-SCIDs And Pre Transplant CMV Infection
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Infection
Precancerous/Nonmalignant Condition
Keywords: infection
precancerous/nonmalignant condition
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-10-22
Sex: FEMALE
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: RATIONALE: Collecting the T cells from a donor and transplanting them into a patient may be effective treatment for immunodeficiency syndrome and CMV infection.

PURPOSE: This clinical trial is studying the emergency use of adoptive immunotherapy with CMV-specific T cells after donor bone marrow transplant of an infant with immunodeficiency syndrome and CMV infection.

Detailed description: OBJECTIVES:

* To determine if adoptive immunotherapy with donor-derived CD4+ and CD8+ CMV- specific cytotoxic lymphocyte cell lines can augment T-cell immunity and treat CMV infection post transplant in a patient with severe combined immunodeficiency syndrome.

OUTLINE: The patient will undergo HLA-matched unrelated donor bone marrow transplantation from a CMV-seropositive donor after undergoing conditioning with 200cGy total-body irradiation per protocol FHCRC Protocol 1227.

CD8-positive and CD4-positive CMV-specific T cells are collected from the donor and used to generate T-cell lines.

If the patient has progressive or persistent CMV infection, then she will receive donor T cells IV over 30 minutes. Infusions may be repeated after at least 14 days if the previous infusion was well tolerated and if the CMV infection is persistent or increasing.

The patient undergoes blood sample collection at baseline and 7 days after T-cell infusion to assess CMV-specific T-cell response.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Adenosine deaminase-deficient severe combined immunodeficiency syndrome (ADA-SCIDs)
* CMV interstitial pneumonia based on the constellation of clinical and radiological findings

PATIENT CHARACTERISTICS:

* Female
* Oxygen desaturation (pulse oximetry 85% on room air)
* Abnormal chest radiograph
* No CMV retinitis

PRIOR CONCURRENT THERAPY:

* Prior ganciclovir and foscarnet sodium

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
name: Thomas Manley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06943235: Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)
Official title: A Prospective, Multicenter, Randomized Controlled, Phase II Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Limited Stage Small Cell Lung Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ADRIATIC study explored the benefits of immune maintenance therapy after LS-SCLC radiotherapy and chemotherapy. In the presence of immunotherapy, is it necessary to increase the dosage of radiotherapy and can it further improve the efficacy? This study aims to explore the efficacy and safety of simultaneous integrated boost hyperfractionation radiotherapy combined with probiotics and Adalberg monoclonal antibody consolidation therapy for small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

1. Sign written informed consent before implementing any experimental procedures;
2. Age range: 18-80 years old;
3. Pathological diagnosis of small cell lung cancer;
4. Limited stage;
5. ECOG PS 0-1；
6. Receive ≤ 2 rounds of chemotherapy or chemotherapy plus immunotherapy;
7. Expected survival time\>3 months;

Exclusion Criteria:

1. Progress after 2 induction treatments;
2. Severe emphysema, interstitial changes in the lungs, COPD patients;
3. Resting blood oxygen\<93;
4. Have a history of other malignant tumors and have received chemotherapy in the past 3 years;
5. History of chest radiotherapy;

Primary outcomes:
measure: one year progression free survival rate
timeFrame: one year
measure: Complete response rate at the end of radiotherapy for one month
timeFrame: at the end of radiotherapy for one month
Secondary outcomes:
measure: One year overall survival rate
timeFrame: one year
measure: one year Survival rate without distant metastasis
timeFrame: one year
measure: Adverse reactions
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT02758535: Renal Parenchymal Core Needle Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Image-guided Biopsy
Complications
Kidney Glomerulus
Lead sponsor: Modarres Hospital
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 166
Sex: MALE
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Percutaneous image-guided parenchymal renal biopsy has been used to detect the different pathologies of renal parenchyma, to define the degree of reversible changes, and to define when the medical treatment fails. Percutaneous core needle renal biopsy has been reported to have a higher diagnostic yield compared to fine needle aspiration. Percutaneous core needle renal biopsy is usually based on tissue sampling under guidance of either sonography or computed tomography. Renal parenchymal biopsy can be done either with a coaxial or noncoaxial technique. In coaxial technique, the introducing needle is placed in the renal parenchyma; then, multiple tissue sampling can be performed throughout the same tract. Alternatively, in noncoaxial technique, biopsy needle is inserted repeatedly for each tissue sampling. Although there are some reports regarding the comparison of coaxial and noncoaxial methods of renal mass biopsy, comparison of the two methods in renal parenchymal biopsy has not yet been described in the literature. In this prospective study, the investigators sought to compare the procedural time and the complication rate of coaxial technique with those of noncoaxial technique in percutaneous renal parenchymal biopsy.


Eligibility criteria: Inclusion Criteria:

* impaired renal function
* proteinuria
* hematuria

Exclusion Criteria:

* renal hydronephrosis
* chronic renal failure
* a history of renal cell carcinoma
* suspicious renal mass
* uncorrectable coagulopathy

Primary outcomes:
measure: complication ratio
timeFrame: within 48 hours after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Rasht
country: Iran, Islamic Republic of
facility: Department of Radiology, Poursina Hospital, Guilan University of Medical Sciences
state: Guilan
Study officials:
References:
Clinical trial NCT00985335: Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis
Official title: Effectiveness of TheraNeem Lip Therapy of Common Symptoms of Herpes Simplex Labialis A Prospective Experimental Case Series (n=5)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Herpes Simplex
Lead sponsor: Southern California University of Health Sciences
Sponsor class: OTHER
First posted: 2009-09-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study intends to test the efficacy of the TheraNeem Lip Therapy balm for Herpes Simplex. The study will include a total of 5 people.

Detailed description: Qualified candidates will be officially enrolled into the study within 24 hours of their subsequent outbreak of Herpes Simplex Labialis. They will be given all of the Neem Therapy products to use, and photographs and questionnaires will be taken to assess their progress.

Eligibility criteria: Inclusion Criteria:

1. Participant has signs and symptoms of HSV-1 infection of less than 24 hours duration to the Southern California University of Health Sciences investigators
2. Participants ages 18-70 years
3. Confirmation of oral-circumoral herpes lesion will be made by a clinician in the presence of oral-circumoral lesion assumed to be HSV-1 for purposes of study
4. Subjects expressed willingness to comply with protocol
5. Subject will be willing to have the presenting lesion photographed twice
6. Subject sign a written informed consent, HIPPA disclosure, Experimental bill of rights

Exclusion Criteria:

1. History of past or present immunosuppressive condition, or currently taking immunosuppressive medication
2. History of adverse effects or allergies to any Neem based product or containing any of the other ingredients TheraNeem Lip Therapy: Organic Coconut Oil, Organic Beeswax, Organic Jojoba Oil, Shea Butter, Sesame Oil, Organic Neem Oil, , Essential Oil of Peppermint, Vitamin E (Tocopherol)
3. Signs of disseminated HSV illness
4. History of use of oral or topical antiviral agents within 10 days of screening and/or at start of study visit
5. Pregnancy or lactation
6. Psychiatric disorder
7. Inability to understand or follow the instructions

Primary outcomes:
measure: Cold Sore Symptom Scale
timeFrame: Baseline and End of Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Southern California University of Health Science
state: California
Study officials:
affiliation: Southern California University of Health Sciences
name: Melany Meier, DC
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern California University of Health Sciences
name: Sivarama Vinjamury, L.Ac
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01247935: Electroacupuncture and Trancutaneous Electrical Nervous Stimulation (TENS) for Colonoscopy Analgesia
Official title: Electroacupuncture and Trancutaneous Electrical Nervous Stimulation Analgesia for Colonoscopy: a Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain
Acupuncture
Transcutaneous electrical nerve stimulation
Colonoscopy
Lead sponsor: Azienda Per I Servizi Sanitari N. 2 Isontina
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the effectiveness of acupuncture and transcutaneous electrical nervous stimulation (TENS) in reducing patient's discomfort during colonoscopy

Detailed description: Evaluation patient's pain and discomfort during colonoscopy, using two non invasive analgesic methods.

Eligibility criteria: Inclusion Criteria:

* all patients scheduled for colonoscopy and in whom deep sedation was not planned will be included in the study

Exclusion Criteria:

* age \> 80 and less than 18 years old, severe cardiac or pulmonary disease, anticoagulant, benzodiazepines, antidepressants, opiates therapies, severe cognitive impairment, uncontrolled hypertension.

Primary outcomes:
measure: Evaluation of patients' discomfort and pain during and at the end of colonoscopy both in acupuncture group and in TENS group compare with controls.
timeFrame: During colonoscopy, we'll evaluate pain at colorectal, left, trasversal and right colon position of colonscope. At the end of colonoscopy, before discharge, we' ll evaluate patient's general discomfort.
Secondary outcomes:
Other outcomes:
Locations:
city: Gorizia
country: Italy
facility: Presidio Ospedaliero di Gorizia
Study officials:
affiliation: ICU Gorizia Hospital
name: Corrado Thomann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sung JJ. Acupuncture for gastrointestinal disorders: myth or magic. Gut. 2002 Nov;51(5):617-9. doi: 10.1136/gut.51.5.617.
citation: Camilleri M. Editorial: is adequate relief fatally flawed or adequate as an end point in irritable bowel syndrome? Am J Gastroenterol. 2009 Apr;104(4):920-2. doi: 10.1038/ajg.2009.20. Epub 2009 Mar 17.
citation: Han JS. Acupuncture and endorphins. Neurosci Lett. 2004 May 6;361(1-3):258-61. doi: 10.1016/j.neulet.2003.12.019.
citation: Fanti L, Gemma M, Passaretti S, Guslandi M, Testoni PA, Casati A, Torri G. Electroacupuncture analgesia for colonoscopy. a prospective, randomized, placebo-controlled study. Am J Gastroenterol. 2003 Feb;98(2):312-6. doi: 10.1111/j.1572-0241.2003.07231.x.
citation: Robinson R, Darlow S, Wright SJ, Watters C, Carr I, Gadsby G, Mayberry J. Is transcutaneous electrical nerve stimulation an effective analgesia during colonoscopy? Postgrad Med J. 2001 Jul;77(909):445-6. doi: 10.1136/pmj.77.909.445.
Clinical trial NCT00150735: Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy
Official title: A Multicenter, Double-blind, Randomized, Parallel Group, Positive-controlled Trial Comparing the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) to Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy for up to a Maximum of 121 Weeks in Subjects (≥ 16 Years) Newly or Recently Diagnosed as Suffering From Epilepsy, and Experiencing Partial or Generalized Tonic-clonic Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Epilepsy
Keywords: Monotherapy, epilepsy, Levetiracetam, Keppra.
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 580
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experiencing partial or generalized tonic-clonic seizures.


Eligibility criteria: Inclusion Criteria:

* Subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures. The discrimination between IC and IIE is not requested for inclusion.
* Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 3 months preceding randomization.
* Subjects with a confirmed diagnosis of epilepsy.
* Male/female subjects (≥16 years).

Exclusion Criteria:

* History or presence of seizures of other types than partial (IA, IB, IC, with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures.
* History or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time, i.e. \< 20 minutes, with or without function regained between 2 ictal events.
* History, clinical or EEG finding suggestive of idiopathic generalized epilepsy (IGE) at randomization.

Primary outcomes:
measure: To demonstrate that levetiracetam monotherapy is not inferior to carbamazepine by measuring the proportion of subjects with 6-month seizure freedom in subjects newly diagnosed as suffering from epilepsy.
Secondary outcomes:
measure: Proportion of subjects with one year seizure freedom; time to first seizure; safety.
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Brodie MJ, Perucca E, Ryvlin P, Ben-Menachem E, Meencke HJ; Levetiracetam Monotherapy Study Group. Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy. Neurology. 2007 Feb 6;68(6):402-8. doi: 10.1212/01.wnl.0000252941.50833.4a.