louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05525650: Comparative Evaluation of Safety and Immune Activity of New Immunotherapeutic Agents for HDM Allergic Rhinitis Patients
Official title: A Randomized, Double Blind, Placebo-controlled, Multiple-dose, Parallel Phase Ⅰ Study to Evaluate Safety and Compare the Immune Stimulating Efficacy of "DF19001" in Dermatophagoides Farinae Sensitized Allergic Rhinitis Volunteers
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Mite Allergy
Rhinitis, Allergic
House Dust Mite Rhinitis
Keywords: Microneedle
Micro Array Patch
House Dust Mite Rhinitis
Lead sponsor: RAPHAS
Sponsor class: INDUSTRY
First posted: 2022-09-01
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When administering clinical trial drugs to patients with house dust mite allergic rhinitis, safety/tolerance is comparatively evaluated as the primary outcome, and symptom improvement and immune activity of the disease are comparatively evaluated as secondary outcome.


Eligibility criteria: Inclusion Criteria:

* Patients aged 19 - 65years with allergic rhinitis caused by the house dust mite antigen.
* ImmunoCAP® titer \> 3.49 kUA/L for the house dust mite antigen.
* Determined to be suitable for clinical trials as a result of laboratory tests.

Exclusion Criteria:

* Patients with uncontrolled, severe, or moderate asthma according to the Global Initiative for Asthma (GINA) guidelines.
* In case of lactation or pregnancy.
* If an infectious disease that may affect this study is identified.
* Patients with a history of rhinology surgery within 6 months prior to the first administration of the clinical investigational drug.
* If the allergy skin prick test is negative for the house dust mite antigen.

Primary outcomes:
measure: Vital signs
timeFrame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
measure: Health examination
timeFrame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
measure: laboratory test
timeFrame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
measure: laboratory test
timeFrame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
measure: laboratory test
timeFrame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
measure: Electrocardiography
timeFrame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
measure: Local Adverse Event
timeFrame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
measure: systemic adverse event
timeFrame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References:
Clinical trial NCT02529150: WISER After Ovarian Cancer - Exercise Pilot Study
Official title: WISER After Ovarian Cancer - Exercise Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: One in four deaths in the United States is due to cancer, and one in three women will develop cancer in her lifetime. Despite improvements in survival among other forms of cancer, ovarian cancer prognosis remains poor. Eighty percent of women with ovarian cancer will present with advanced disease (stage 3 or 4) where 5-year survival ranges from 18-34%.2 Among patients with stage III and IV epithelial ovarian cancer (EOC), recurrence rates are high.4 Therefore, interventions focused on preventing recurrence or slowing progression of EOC is a critical problem in the field. The investigators have submitted an R21 to NCI for a dose response exercise intervention trial to examine the dose response effects of aerobic exercise on biomarkers relevant to ovarian cancer progression and recurrence. The reviewers would like assurance that the investigators can recruit ovarian cancer patients into an exercise study and that these women will do the exercise protocol we plan to prescribe in our high dose of exercise.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage III-IV EOC, completed surgery,
* \> 12 months life expectancy (physician estimate),
* able to walk 15 minutes at a time (use of a cane is acceptable).

Exclusion Criteria:

* medical or psychiatric conditions (beyond ovarian cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e.g. cardiac, pulmonary, or
* orthopedic history that would prohibit a program of walking for exercise;
* psychotic disorders,
* dementia,
* inability to give informed consent

Primary outcomes:
measure: Number of adverse events
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Kathryn Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06381050: The Clinical Study of SHR-7631 for Injection in Patients With Advanced Solid Tumors
Official title: An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7631 for Injection in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-24
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label, phase I clinical trial of SHR-7631 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.


Eligibility criteria: Inclusion Criteria:

1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
2. Have at least one measurable tumor lesion per RECIST v1.1 (subject with only non-target tumor lesion will be permitted if he/she is planned to participant in dose escalation stage or with mCRPC);
3. ECOG performance status of 0-1;
4. Life expectancy ≥ 12 weeks;
5. Adequate bone marrow and organ function
6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
7. Age 18 to 75 years old (including both ends), gender is not limited;

Exclusion Criteria:

1. Patients with active central nervous system metastases or meningeal metastases;
2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;
4. History of serious cardiovascular and cerebrovascular diseases;
5. Severe infection within 4 weeks prior to the first dose;
6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Primary outcomes:
measure: Maximum tolerated dose (MTD) or maximum administered dose (MAD)
timeFrame: 12 months
measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0)
timeFrame: 36 months
Secondary outcomes:
measure: PK parameter: Tmax
timeFrame: 36 months
measure: PK parameter: Cmax
timeFrame: 36 months
measure: PK parameter: AUC0-t
timeFrame: 36 months
measure: PK parameter: AUC0-∞
timeFrame: 36 months
measure: PK parameter: t1/2
timeFrame: 36 months
measure: PK parameter: MRT (mean residence time)
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangzhou
Study officials:
References:
Clinical trial NCT02588755: TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection
Official title: Anti-tumor Recurrence With Transarterial Chemoembolization (TACE) Plus Tegafur Versus TACE on Patients With Intrahepatic Cholangiocarcinoma After Curative Resection：A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: Chemoembolization
Therapeutic
Tegafur
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) plus Tegafur with TACE alone in patients with intrahepatic cholangiocarcinoma after curative resection


Eligibility criteria: Inclusion Criteria:

* Male or female patients \> 18 years and \<=70 years of age.
* Pathological evidence of ICC
* Tumors can be completely resected.
* Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
* Patients who can understand this trial and have signed information consent.

Exclusion Criteria:

* Tumors can not be resected .
* Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma.
* Patients with a medical history of other malignant tumors.
* Subjects participating in other clinical trials.
* Liver function:Child C.

Primary outcomes:
measure: Overall survival rates of each group
timeFrame: 3 years
Secondary outcomes:
measure: Occurrence rate of recurrence of each group
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05673655: Intraoral Injection of Trigger Points by Botox
Official title: Evaluation of Ultrasound Sonography Intraoral Guided Injection of Botulinum Toxin in Masseter Muscle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Myofacial Pain
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with orofacial pain lasting at least 3 months. The patients will be randomly assigned to one of the two groups according to the treatment method: group I (intraoral injection) and group II (transcutaneous injection) where each patient injected Botox at each trigger point according to the treatment group by the same operator. Patients will be examined by a blinded investigator at pre- and post-injections at the following intervals: during diagnosis, 1 week, 4, and 6 weeks post-injection. The patients will be assessed using a pain score measured on a 10-point visual analog scale (VAS). The secondary outcome assessed will be measuring the quality of life in an Oral Health Impact Profile questionnaire (OHIP-14).


Eligibility criteria: Inclusion Criteria:

* Definite diagnosis of myofascial pain with a referral
* the presence of one or more trigger points in the unilateral or bilateral masseter muscle -
* no history of any invasive procedures in the related masseter muscle

Exclusion Criteria:

* Factors that can cause pain in the orofacial region other than trigger points (decayed tooth, temporomandibular joint internal disorder).
* Any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsy
* pregnancy and lactation.

Primary outcomes:
measure: pain score
timeFrame: 6 weeks post injection
Secondary outcomes:
measure: (OHIP-14) scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
References:
Clinical trial NCT04135755: The Spine Kinematics and Center of Pressure Excursion During Functional Task Vertebral Compression Fractures Subjects
Official title: The Spine Kinematics and Center of Pressure Excursion During Functional Task in Scoliosis and Vertebral Compression Fractures Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posture
Vertebral Compression Fracture
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
Collaborators: name: Hungkuang University
First posted: 2019-10-23
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study enrolled 13 adults with VCF, 13 older adult without spinal deformity, and 13 young adults.

Brief summary: This study aimed to assess the sensory and kinematic components of the limits of stability (LOS) test in patients with vertebral compression fracture (VCF) .

Detailed description: This study enrolled adults with VCF (VCF group), older adult without spinal deformity (NE group), and young adults (NY group). The Biodex balance system was employed to calculate the balance score and the LOS of participants. An inertia motion system was used to record kinematic data. The center of pressure (COP) signals of postural stability and LOS were used to calculate the frequency power spectrum for interpreting the sensory component.

Eligibility criteria: Vertebral compression fracture Inclusion Criteria:

older than 65 years osteoporosis diagnosed by a bone mineral density test of the lumbar spine (T-score \< -2.5; T: peak bone mass) thoracic-lumbar VCF on radiography without displacement

Vertebral compression fracture Exclusion Criteria:

other spinal diseases that might also cause back pain (such as scoliosis, lumbar spondylolisthesis, lumbar disk disease, and spinal stenosis) a history of diabetes a history of neurological disease (such as cerebral vascular disease, peripheral neuropathy and vestibular disease).

Control Inclusion Criteria:

None the control participants had evidence of gait, postural, or spine disorders.

Primary outcomes:
measure: Postural Stability
timeFrame: 90 second
measure: limits of stability
timeFrame: 1-2 minutes
measure: Kinematic Data
timeFrame: 5 minutes
measure: timed up-and-go test
timeFrame: 90 second
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taichung Veterans General Hospital
name: Shin-Tsu Chang, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lynn SG, Sinaki M, Westerlind KC. Balance characteristics of persons with osteoporosis. Arch Phys Med Rehabil. 1997 Mar;78(3):273-7. doi: 10.1016/s0003-9993(97)90033-2.
citation: Kuo FC, Chang ST, Liao YY, Lee CH. Center of Pressure Trace and Sensory Components of the Limits of Stability Test in Older Adults With Vertebral Compression Fractures. J Geriatr Phys Ther. 2020 Jan/Mar;43(1):24-31. doi: 10.1519/JPT.0000000000000201.
Clinical trial NCT05521555: Return to Work After Total Knee Arthroplasty in Young Patients
Official title: Return to Work After Total Knee Arthroplasty in Patients Under 55, a Retrospective Study in an University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Arthritis
Keywords: total knee arthroplasty
return to work
arthroplasty
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent a total knee arthroplasty, under 55 at the time of surgery, with or without professional activity at the time of surgery

Brief summary: This study takes its base in the augmenting number of primary total knee arthroplasty in the world whom quality and survey had permit to widen their indications to younger patients who are in the age of professional activity.

This work will focus on young patients under 55 who had had primary total knee arthroplasty, retrospectively, over the past 10 years, to determine the factors influencing early or late return to work, depending of socio economics factors.

This will optimize the information for the patient, and prepare him if necessary for a long work stop, and possibly obtain a better satisfaction for him.

Detailed description: The primary aim of this study is to determine the rate of young patients returning to work after a primary total knee arthroplasty and the mean delay, and to compare it to other studies.

The mean delay of return to work in the literature is between 8 to 12 weeks, with up to 98% of patients returning to work.

The investigators will next determine which category of patients could have a late return to work superior to 6 months, and also if the surgery could give back a professional activity to patients who were in a long work stoppage.

Eligibility criteria: Inclusion Criteria:

* first intention total knee arthroplasty
* Age at the time of surgery under 55

Exclusion Criteria:

* Not in capacity of completing a questionnaire
* revision of total knee arthroplasty

Primary outcomes:
measure: Return to work in weeks
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy, Hopital central
state: Meurthe Et Moselle
Study officials:
affiliation: CHRU Nancy
name: Didier MAINARD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00179855: Extracorporeal Photopheresis for Acute Graft Versus Host Disease
Official title: Extracorporeal Photopheresis for Steroid-refractory Acute GVHD in Children and Young Adults: a Safety and Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Graft Versus Host Disease
Cancer
Stem Cell Transplantation
Keywords: graft versus host disease
ECP
extracorporeal photopheresis
allogeneic transplantation
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 10
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate the safety and feasibility of extracorporeal photopheresis (ECP) in the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in children.


Eligibility criteria: Inclusion Criteria:

* Status-post allogeneic stem cell transplant (includes cord blood transplant, matched-unrelated-donor transplant and matched-related donor transplant) for any indication.
* HLA matching needs to be 4-6/6 by at least intermediate resolution for class I + II for cord blood and 5-6/6 for matched related or matched unrelated donors.
* Diagnosis of grade II-IV acute GVHD with histological confirmation of at least one organ (skin, gut, or liver) within the last 14 days. Grading of acute GVHD is per the standard Keystone criteria. Prior to enrollment, efforts should be made to rule out diagnoses that may mimic GVHD, such as drug rashes or GI infection. Patients that are being treated for acute GVHD and appear to be progressing to chronic GVHD are also eligible
* No improvement, or worsening, of acute GVHD after at least 4 days of IV methylprednisolone dosed at, at least 2.0mg/kg/day..
* Weight \>25.0kg.
* Adequate venous access.

Exclusion Criteria:

* Evidence of veno-occlusive disease.
* Intubated patient.
* Patient receiving dialysis.
* Age \> 30.
* Total bilirubin \>15mg/dL

Primary outcomes:
measure: To evaluate the safety and feasibility of extracorporeal photopheresis (ECP) in the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in children.
timeFrame: To end of study
measure: To estimate the response rate of ECP in steroid-refractory acute GVHD in children.
timeFrame: To end of study
Secondary outcomes:
measure: To evaluate the immunological mechanisms of ECP in acute GVHD.
timeFrame: To end of study
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Morris Kletzel, MD
role: STUDY_DIRECTOR
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Sonali Chaudhury, MD
role: PRINCIPAL_INVESTIGATOR
References: