louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05649475: Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy
Official title: Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stage I-III Breast Cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: GeneCast Biotechnology Co., Ltd.
First posted: 2022-12-14
Enrollment: 100
Sex: ALL
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: Patients with stage I-III breast cancer

Brief summary: In the prospective, open, observational study, we aim to evaluate whether circulating tumor DNA (ctDNA) can be the marker of the response to neoadjuvant therapy in stage I-III breast cancer.


Eligibility criteria: Inclusion Criteria:

* Patient is ≥ 18 years-old at the time of consent to participate this trial
* Patients with stage I-III invasive breast cancer
* No prior anti-cancer treatment
* Felt to be a possible candidate for neoadjuvant therapy by their physician

Exclusion Criteria:

* Known to have other aggressive malignant tumor in the past 5 years.
* Breast cancer during lactation; Inflammatory breast cancer; Acute inflammatory disease, pregnancy and other conditions may affect the levels of ctDNA and/or peripheral inflammatory indicators.
* There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
* The investigator determines that subjects are not appropriate to participate in the study due to other factors.

Primary outcomes:
measure: Miller-Payne grading system
timeFrame: 3 years
measure: Residual cancer burden (RCB)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Study officials:
References:
Clinical trial NCT01399775: Evaluation of Ridge Dimensional Changes After Immediate Implantation and Efficacy of This Procedure
Official title: Evaluation of Implant Stability and Dimensional Changes in Alveolar Ridge Following Immediate Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Atrophy of Edentulous Alveolar Ridge
Alveolar Ridge Augmentation
Keywords: Atrophy of Edentulous Alveolar Ridge
Dental Prosthesis, Implant-Supported
Dental Implants, Single-Tooth
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Evaluation of dimensional changes in alveolar ridge following immediate implantation compared to delayed implantation
2. evaluation of the effect of gap dimensions between socket walls and dental implant in implant stability

Detailed description: 24 hopeless single root teeth will be selected. The horizontal and vertical measurements will be assessed in 12socket after immediate implantation and filling the gape with DFDBA.

Horizontal dimensions (bucco-lingual) of alveolar ridge will be measured at 1,3 and 7 mm using caliper and CBCT , and vertical ridge dimensions at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ) will be determined using a periodontal probe from the line connecting the two adjacent CEJs ,and dimensional changes will be measured after 3 months following implant insertion with the same device during the second stage surgery.

The vertical and horizontal dimensions between the implant and alveolar crest and between the crest and base of the gap will be measured at 8 points:(mid-buccal,mid-lingual,mesial,distal,disto-buccal-mesio-buccal,disto-lingual,mesio-lingual ).

The primary and secondary stability will be measured using Osstell at baseline and 3-month later.

Twelve sockets will heal without grafting materials, soft and hard tissue measurements including horizontal and vertical ridge dimensions will be determined. All the measurement will be assessed using caliper and CBCT at the time of extraction and 3-month later at the time of implant insertion.

Eligibility criteria: Inclusion Criteria:

* Patients with hopeless single root tooth and willing for dental implants
* Having no systemic disease

Exclusion Criteria:

* Fail to osseointegrate

Primary outcomes:
measure: dimensional changes
timeFrame: baseline to 3 months
Secondary outcomes:
measure: implant stability
timeFrame: baseline to 3 months
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University of Medical Sciences, Dental school
state: Khorasan Razavi
Study officials:
affiliation: Mashhad University of Medical Sciences
name: Mehrdad Radvar, DDS., Phd
role: STUDY_CHAIR
References:
Clinical trial NCT02790775: Pain and Visual Outcome in Intravitreal Bevacizumab Injection
Official title: Evaluation of the Pain and Visual Outcome Associated With Location of Intravitreal Bevacizumab Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-06-06
Enrollment: 1004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this double blind clinical trial, 1000 patients suffering from diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions are included. Those with the history of Ocular pain prior to the procedure, any contraindication for Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (VAS) are excluded from the study. Before starting the treatment all patients undergo complete ophthalmic exam , best-corrected visual acuity (BCVA) checking and macular thickness measurements using optical coherence tomography (OCT). Patients are randomly assigned to each group .Each participant receive one injection in one eye in this study. Pain is measured by subjective grading on a Visual Analog Scale (VAS) immediately after IVI. BCVA and OCT would be checked again at month one.


Eligibility criteria: Inclusion Criteria:

* diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions

Exclusion Criteria:

* history of Ocular pain prior to the procedure, any contraindication for Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (VAS)

Primary outcomes:
measure: Pain
timeFrame: immediately after Intravitreal Bevacizumab Injection
Secondary outcomes:
measure: Best-corrected visual acuity (BCVA)
timeFrame: preoperative and 1 month postoperatively.
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Islamic Republic of Iran
Study officials:
References:
Clinical trial NCT04907175: Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)
Official title: Individual Patient Expanded Access IND to Evaluate the Safety and Efficacy of HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: System; Lupus Erythematosus
Lead sponsor: Hope Biosciences
Sponsor class: INDUSTRY
Collaborators: name: Hope Biosciences
First posted: 2021-05-28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT

Brief summary: This protocol is part of an FDA Individual Patient Expanded Access IND. This study is to be conducted according to US and International Standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Hope Biosciences Stem Cell Research Foundation policies and procedures.

Detailed description: This Individual Patient Expanded Access IND has been created per the request of a 65-year-old woman diagnosed with Systemic Lupus Erythematosus (SLE).

Eligibility criteria: Inclusion Criteria:

* Adult individual 18 years of age or older.
* Cognitively intact and capable of giving informed consent.
* Clinical diagnosis of Systemic Lupus Erythematosus.
* Subject has mesenchymal stem cells banked at Hope Biosciences.
* The patient accepts to receive treatment and to comply with follow-up visits.

Exclusion Criteria:

* Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or endocrine diseases that in the opinion of the investigator may increase the risks associated with study participation.
* Active Alcohol or Drug addiction.
* Participation in concurrent interventional research studies during this study.
* Severe organ failure (heart, kidney or liver) confirmed by additional tests or medical history.
* Unwillingness to return for follow-up visits.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sugar Land
country: United States
facility: Hope Biosciences Stem Cell Research Foundation
state: Texas
Study officials:
affiliation: Hope Biosciences Stem Cell Research Foundation
name: Thanh Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02062775: Comparison of Self-Fixating vs Non-Fixating Hernia Mesh
Official title: A Randomized Controlled Study of Self Fixating Mesh Versus Non Fixating Polyester Mesh for Laparoscopic Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2014-02-14
Enrollment: 285
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 purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair.

Detailed description: This is a randomized, blinded comparison of self-gripping mesh and standard polyester mesh for laparoscopic, primary inguinal hernia repair performed in a Totally ExtraPeritoneal (TEP) fashion.

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* ASA Classification I, II, III
* scheduled for elective TEP inguinal hernia repair

Exclusion Criteria:

* ASA Classification IV or greater
* needing emergency surgery
* known history of narcotic dependence
* undergoing bilateral inguinal or combined umbilical hernia repair
* undergoing other procedures during same anesthetic
* undergoing recurrent inguinal hernia repair

Primary outcomes:
measure: Chronic postoperative pain
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of hernia recurrence
timeFrame: 1 year
Other outcomes:
measure: Post-Op adverse events related to mesh
timeFrame: 1 year
measure: Post-Op quality of life and pain scores
timeFrame: 1 year
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: John Linn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05659875: CompARing Long terM Outcomes in Chronic Stroke Survivors Across Investigational Assessments Following a Prescribed Upper Extremity Exercise Program
Official title: CompARing Long terM Outcomes in Chronic Stroke Survivors Across Investigational Assessments Following a Prescribed Upper Extremity Exercise Program (ARM-PROGRAM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Keywords: chronic stroke
stroke
arm impairment
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare assessments of arm function following a standard exercise program in chronic stroke patients.


Eligibility criteria: Inclusion Criteria:

* Single qualifying stroke event as confirmed by CT or MRI
* At least 1 month post stroke
* Score of at least 2-/5 on Manual Muscle Test for wrist flexors or extensors, indicating adequate movement to complete robotic device use
* Able to follow written instructions

Exclusion Criteria:

* Prior arm injury impacting available passive or active range of motion or significant arm pain with movement
* Underlying brain pathologies such as metastatic or primary brain malignancies, comorbid multiple sclerosis, etc.
* Prior significant drug or alcohol abuse
* Diagnosed with dementia
* Pre-stroke baseline modified Rankin Scale (mRS) \>3
* History of seizure/epilepsy
* History of clinically significant ischemic or hemorrhagic stroke prior to index stroke resulting in prior arm injury or weakness.
* Pregnancy
* Contraindication to MRI or Transcranial Magnetic Stimulation (TMS).
* Medical instability assessed by the treating stroke physician to participate to the study.

Primary outcomes:
measure: change in arm impairment as assessed by Fugl Meyer - Upper Extremity assessment
timeFrame: Baseline, month 4, month 8, month 12, month 16, month 20, month 24
Secondary outcomes:
measure: Change in integrity of corticospinal tract fibers as assessed by MRI with Diffusion Tensor Imaging (DTI).
timeFrame: Baseline, month 24
measure: Change in motor evoked potential as assessed by Transcranial Magnetic Stimulation
timeFrame: Baseline, month 4, month 8, month 12, month 16, month 20, month 24
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: UTHealth Houston
name: Sean Savitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01459575: Unboosted Atazanavir as Initial ART Therapy in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antiretroviral Therapy
Keywords: Acquired Immunodeficiency Syndrome
antiretroviral therapy
China
Lead sponsor: National Center for AIDS/STD Control and Prevention, China CDC
Sponsor class: OTHER_GOV
Collaborators: name: BMS company
First posted: 2011-10-25
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ART-naïve patients, established HIV infection \> 6 months with CD4 count of 100\~350 cell/mm3

Brief summary: This is an open-label, Pilot study.The study hypothesis is that the feasibility and efficacy of a non-boosted ATV based HAART will be well as the first line treatment in a Chinese resource-limited setting.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* The subject should have established HIV infection more than 6 month.
* Qualifying plasma HIV RNA ≥ 2,000 c/mL and a CD4 cell count within 100 - 350 cells/mm3
* ≥16 years of age
* Both females of child-bearing potential and males must utilize effective barrier contraception - other contraception in addition to barrier methods are permitted
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

* Patients who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
* Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
* History of hemophilia
* Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver function enzymes are \< 3 times the upper limit of normal.
* Presence of cardiomyopathy.
* A history of arrhythmia or clinical symptoms potentially related to heart block or second / third degree heart block.
* Inability to tolerate oral medication
* Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yan Zhao
Study officials:
affiliation: National Center for AIDS/STD control and prevention
name: Fujie Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01594775: Oxytocin, Couple Interaction and Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2012-05-09
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: effects of intranasal oxytocin and couple interaction on wound healing.

* Trial with medicinal product


Eligibility criteria: Inclusion criteria:

* healthy heterosexual couples
* in a stable relationship since \> 1 year

Exclusion criteria: pregnancy

* breast feeding
* heavy smoking (\> 5 cigarettes/d)
* extensive skin disease
* artificial UV irradiation during \< 3 months before study inclusion

Primary outcomes:
measure: wound size
timeFrame: seven days
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Dept. of Dermatology
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Division of Dermatology
name: Severin Laeuchli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doerr JM, Klaus K, Troxel W, Nater UM, Bodenmann G, Heinrichs M, Ehlert U, Ditzen B. The Effect of Intranasal Oxytocin on the Association Between Couple Interaction and Sleep: A Placebo-Controlled Study. Psychosom Med. 2022 Jul-Aug 01;84(6):727-737. doi: 10.1097/PSY.0000000000001091. Epub 2022 Apr 27.
Clinical trial NCT01531075: Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease
Official title: Assessment of Hepatitis B Vaccination Efficacy in Patients With Inflammatory Bowel Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease
Keywords: HBV, Inflammatory bowel disease, immunosuppressor
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of IBD patients treated with immunosuppressive medications.


Eligibility criteria: Inclusion Criteria:

* Male/female ≥ 18 years of age
* Evidence of IBD as diagnosed by clinical, laboratory imaging and endoscopic criteria.
* Treated with at least one immunosuppressive medication at the time of study initiation
* Provided written informed consent.

Exclusion Criteria:

* Pregnant women
* Diagnosis of chronic viral hepatitis B
* Any major acute medical event in the 30 days prior to recruitment that necessitated hospitalization ( acute myocardial infarction, CVA, pulmonary emboli, sepsis, major trauma)
* Any other chronic inflammatory condition not related to IBD ( connective tissue disease, Chronic liver disease, COPD, poorly controlled diabetes mellitus)
* Active hematologic or oncologic diseases

Primary outcomes:
measure: protective level of anti HBs antibodies
timeFrame: 1 month after the last does of vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Beer- Sheva
country: Israel
facility: Soroka UMC
Study officials:
affiliation: Soroka UMC
name: Ohad Etzion, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01057875: Effects of Caffeine on Methacholine Challenge and Exhaled Nitric Oxide Levels.
Official title: The Effects of Caffeine on Exhaled Nitric Oxide Levels and Methacholine PC20
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2010-01-27
Enrollment: 15
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: To investigate whether or not the ingestion of caffeine with alter airway responsiveness to methacholine and/or change the level of exhaled nitric oxide.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of asthma
* FEV1 greater than 65%

Exclusion Criteria:

* asthma is poorly controlled
* presence of other airway disease (e.g. COPD)

Primary outcomes:
measure: methacholine pc20
timeFrame: 1 hour post ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Donald W Cockcroft, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yurach MT, Davis BE, Cockcroft DW. The effect of caffeinated coffee on airway response to methacholine and exhaled nitric oxide. Respir Med. 2011 Nov;105(11):1606-10. doi: 10.1016/j.rmed.2011.06.006. Epub 2011 Jul 2.