louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06368167: A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma
Official title: A Phase II, Single-arm, Open-label, Multicenter Study on the Efficacy of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Follicular Lymphoma
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma


Eligibility criteria: Inclusion Criteria:

1. Males or females aged ≥18 years
2. Histologically confirmed follicular lymphoma
3. Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2
4. Life expectancy ≥ 12 weeks
5. Treated with CD20 antibody, refractory to or relapse from prior anti-cancer therapies
6. Have measurable lesions
7. The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures

Exclusion Criteria:

1. Have been treated with a compound of the same machanism;
2. Accompanied by central nervous system infiltration;
3. Received autologous stem cell transplantation within 60 days before signing the agreement, and received allogeneic stem cell transplantation or CAR-T therapy within 90 days;
4. Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug
5. Known active infection
6. History of clinically severe cardiovascular diseases
7. Have other malignancies within 5 years prior to screening Pregnant or lactating women
8. The subject is unable to swallow, or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticulosis, or a history of gastrectomy or gastric banding that affects drug absorption.
9. The subject is taking a known medium or strong CYP inducer.
10. Based on the investigator's judgment, there are objective conditions that may prevent the subject from completing the study as planned or the subject has other factors, concomitant diseases, concomitant treatments, or abnormal laboratory findings that may lead to early study termination

Primary outcomes:
measure: Objective response rate (ORR) assessed by independent review committee (IRC)
timeFrame: around 1 year
Secondary outcomes:
measure: ORR assessed by investigator
timeFrame: around 1 year
measure: Progression free survival
timeFrame: around 1 year
measure: Time to Response
timeFrame: around 4 months
measure: Duration of response
timeFrame: around 1 year
measure: Overall survival
timeFrame: around 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03122067: Oxytocin's Effect on Social Pain Empathy
Official title: Oxytocinergic Modulation of Perceived Social Exclusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: oxytocin
social cognition
fMRI
empathy
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present experiment is to examine oxytocin's behavioral and neural effects on social pain empathy

Detailed description: In the current study, the investigators plan to examine whether oxytocin modulates behavior and neural activity during observing another person being excluded in an online ball-tossing game (a modified cyberball paradigm).

Eligibility criteria: Inclusion Criteria:

* healthy participants without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness
* smoking or drinking 24 hours before experiment

Primary outcomes:
measure: Neural activity changes associated with oxytocin administration
timeFrame: 45-60 minutes after drug administration
Secondary outcomes:
measure: Behavioral changes associated with oxytocin administration: ball-tossing
timeFrame: 45-60 minutes after drug administration
Other outcomes:
Locations:
city: Chendu
country: China
facility: School of Life Science and Technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: School of Life Science and Technology, University of Electronic Science and Technology of China
name: Keith Kendrick, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04241367: Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy
Official title: Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreas Adenocarcinoma
Keywords: Pancreas Adenocarcinoma
Circulating-tumor DNA
KRAS mutations
Cancer Panel
Prognostic markers
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2020-01-27
Enrollment: 420
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatient or outpatient

Brief summary: This study is for verification of predictive biomarkers for pancreatic cancer treatment using multi-center liquid biopsy.

Detailed description: Clinical applicability of KRAS mutations using circulating-tumor DNA in pancreatic cancer patients.

* Quantification and monitoring of KRAS mutations Using droplet digital PCR in ctDNA extracted from collected patient samples.
* Correlation analysis of KRAS mutation results with clinical data.

Discovery of biomarkers for predicting pancreatic cancer prognosis through ctDNA panel.

* Gene panel composition for pancreatic cancer therapeutic target determination and monitoring.
* A panel was performed using gDNA and ctDNA of tumor tissue collected from pancreatic cancer patients.
* Comparative analysis of panel results and quantitative KRAS mutations and evaluation of clinical applicability.

Eligibility criteria: Inclusion Criteria:

* Patients with pathologically confirmed pancreatic adenocarcinoma.

Exclusion Criteria:

* Patients disagree with the study.

Primary outcomes:
measure: Clinical applicability of KRAS mutations
timeFrame: Locally advanced and Resectable patients: Pre Treatment, 1,2,3,6,9,12,15,18,21,24months/ Metastatic patients: Pre Treatment, 1,2,4,6,8,10,12,14,16,18,20,22,24 months
measure: Discovery of biomarkers through ctDNA panel
timeFrame: Locally advanced and Resectable patients: Pre Treatment, 1,2,3,6,9,12,15,18,21,24months/ Metastatic patients: Pre Treatment, 1,2,4,6,8,10,12,14,16,18,20,22,24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center
name: Sangmyung Woo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00907504: Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
Official title: Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-22
Enrollment: 0
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: Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.


Eligibility criteria: Inclusion Criteria:

* Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive
* Male or female \> 18 years
* Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1
* Adequate organ function

Exclusion Criteria:

* Uncontrolled hypertension or diabetes;
* Pregnant female;
* Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.

Primary outcomes:
measure: Overall Survival
timeFrame: Dec 2012
Secondary outcomes:
measure: Progression Free survival
timeFrame: Dec 2011
measure: Objective Response
timeFrame: Dec 2011
measure: Overall Safety Profile
timeFrame: Dec 2012
measure: Patient Reported Outcome
timeFrame: Dec 2012
measure: Pharmacokinetics
timeFrame: Dec 2012
measure: Anti-drug Antibody
timeFrame: Dec 2012
measure: Biomarker Analysis
timeFrame: Dec 2012
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02922504: Impact of Music Intervention on Pain Control In First Trimester Surgical Abortion Under Local Anesthesia
Official title: Impact of Music Intervention on Pain Control In First Trimester Surgical Abortion Under Local Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: First Trimester Abortion
Surgical Abortion
Music Intervention
Local Anesthesia
Pain
Keywords: First trimester abortion
Surgical abortion
Music intervention
Local anesthesia
Pain
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-10-04
Enrollment: 159
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A surgical abortion under local anesthesia is potentially painful. A protocol using analgetic is systematically used. Also the protocol is relevant , the question of taking care of the pain in a safe manner remains.

The use of Music during surgery can have a real effect on pain and anxiety. This study has for goal to evalued the use of music on pain as adjuvant treatement instead of a standard care for an abortion.

Detailed description: A surgical abortion under local anesthesiac is potentially painful. A protocol using analgetic is systematically used. Also the protocol is relevant, the question of taking care of the pain in a safe manner remains.

The use of Music during surgery can have a real effect on pain and anxiety. This study has for goal to evalued the use of music on pain as adjuvant treatment instead of a standard care for an abortion.

The number of patients needed is estimate to be eighty patients per group.

The result of the study could allow :

* Showing the effectiveness of music intervention before operative abortion as adjuvant treatment on the pain, anxiety and nausea during a surgical abortion by suction aspiration under local anesthesia.
* Improving the experience of an abortion and the satisfaction of the patients as well as lowering the use of drugs.

Eligibility criteria: Inclusion Criteria:

* Every patients must have more than 18 years old
* Hospitalised at the Angers Hospital for a surgical abortion under local anesthesia.
* Affiliated or be part of the french Sécurité Sociale ( health service )
* To have signed a consent form

Exclusion Criteria:

* Patients not speaking french
* People who should not use music intervention ( Total or partial hearing difficulties)
* No consent given
* Adults protected by the law
* Not being part of another medical study

Primary outcomes:
measure: the effectiveness on the pain of music therapy by the pain evaluation with visual numeric scale
timeFrame: during one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01023204: Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Breast Cancer
Official title: Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 68
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent breast cancer


Eligibility criteria: Inclusion Criteria:

* Patients with primary advanced inoperable disease who were refractory to chemotherapy
* Patients with recurrent disease following post-operative adjuvant chemotherapy
* Patients who were not amenable to post-recurrence chemotherapy

Exclusion Criteria:

* Patients with serious, uncontrolled medical illness
* Patients with previous therapy with taxanes

Primary outcomes:
measure: Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on predetermined evaluation criteria
timeFrame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
measure: Safety: incidence and severity of adverse events, laboratory test abnormalities
timeFrame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Secondary outcomes:
measure: Duration of response, defined as either Complete or Partial Response, based on Evaluation Criteria on Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer
timeFrame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03893604: Effects of tDCS on High Level and Recreational Athletes
Official title: Comparing the Effects of tDCS on Endurance Parameters Between High Level and Recreational Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Athlete
Keywords: tDCS
Athlete
Isokinetic
Endurance
Fatigue
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, triple-blind, sham-controlled, crossover
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Healthy recreational and high level athletes will undergo 2 randomized, cross-over counterbalanced sessions of anodal tDCS or sham tDCS.

The primary outcome is an isokinetic evaluation of their hamstrings' and quadriceps' endurance after each session

Detailed description: Recruitment :

Healthy recreational and high level athletes will be recruited through social media and advertisements.

Each subject came twice to the Liege University Hospitals' isokinetic lab. Each session began with strapping the subjet into the isokinetic machine, making sure that all the settings were adapted to the subject. Then, each subject received either anodal tDCS, of sham tDCS. Neither the evaluator or the subject knew which they were receiving. Immediately following tDCS, there was a warmup consisting of stationary bike, and an isokinetic warmup. Then, subjects' endurance was using a maximal isokinetic tests, at 30 maximal concentric and eccentric contractions at a speed of 180°/s.

Eligibility criteria: Inclusion Criteria:

* For the "recreational" group at most 3 hours of sport a week
* For the "athletic" group, at least 10 hours of sport a week
* Right handed and footed

Exclusion Criteria:

* One on the TSST (in high and relatively high risk sections)
* Previous neurological or orthopedic pathologies affecting limbs

Primary outcomes:
measure: Peak Strength
timeFrame: Immediately after tDCS and sham
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Liege Univeristy Hospital
Study officials:
affiliation: Liege University Hospital
name: Stephen Bornheim, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06983704: Assessing Combined Bevacizumab-Mitomycin C Use During Ahmed Valve Revision in Recurrent Pediatric Glaucoma
Official title: Evaluation of Combined Bevacizumab-Mitomycin C Use During Ahmed Valve Revision in Recurrent Pediatric Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pediatric Glaucoma
Keywords: Pediatric glaucoma
Ahmed valve
bevacizumab
mitomycin C
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 50
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To asess the efficacy and safety of combining subconjunctival bevacizumab with mitomycin C (MMC) during AGV revision surgery in pediatric patients with recurrent glaucoma.

Detailed description: Recurrent pediatric glaucoma following Ahmed Glaucoma Valve (AGV) implantation presents a therapeutic challenge. This study evaluates the efficacy and safety of combining subconjunctival bevacizumab with mitomycin C (MMC) during AGV revision surgery in pediatric patients with recurrent glaucoma.

Eligibility criteria: Inclusion Criteria:

* children under 12 years with previous AGV implantation for primary congenital glaucoma

Exclusion Criteria:

* age \>12 years, eyes with no light perception, and those with prior cyclodestructive procedures.

Primary outcomes:
measure: surgical success
timeFrame: for 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University
Study officials:
References:
Clinical trial NCT00444704: Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Japanese Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Uterine Leiomyomata (Fibroids)
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-08
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to assess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females. The secondary purpose is to provide the initial pharmacokinetic and pharmacodynamic profiles of PRA-027 in healthy Japanese female subjects.


Eligibility criteria: INCLUSION CRITERIA

1. Women of nonchildbearing potential aged 20 to 64 years. Must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan.
2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight must be at least 45 kg.
3. Healthy as determined by the investigator on the basis of screening evaluation.

EXCLUSION CRITERIA

1. Any significant cardiovascular, hepatic, renal, respiratory, gynecologic gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
2. Any history of drug abuse or admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
3. Use of any investigational drug within 90 days before study day 1, use of any prescription drug within 30 days before study day 1, consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages within 48 hours before study day 1, consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1, use of any over-the-counter drugs, including herbal supplements (except for the occasional use of vitamins ≤100% of the recommended daily allowance), within 14 days before study day 1, or the donation of blood within 90 days before study day 1.

Primary outcomes:
measure: The primary outcome of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females.
Secondary outcomes:
Other outcomes:
Locations:
city: Tsukuba
country: Japan
state: Ibaraki Prefecture
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01118104: Sickness Absence Versus Physical, Mental, and Job-related Factors in Patients With Chronic Pulmonary Disease
Official title: Relationships Between Sickness Absence and Physical, Mental, and Job-related Factors in Patients With Chronic Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Asthma
Lead sponsor: LHL Helse
Sponsor class: OTHER
First posted: 2010-05-06
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: People with chronic respiratory disease have shortened work life, their disease is associated with greater work disability and they are at greater risk of being unemployed. Lower employment rates and higher sickness absence is expensive for the community and leads to financial as well as social consequences for the individual.

There is a lack of data on factors that can predict sickness absence and disability in patients with pulmonary disease. We therefore want to study a group of people with COPD and asthma referred to our clinic. The study will investigate relationships between sickness absence and exercise capacity, job-related factors, disease severity, self-efficacy, health related quality of life and subjective health complaints.


Eligibility criteria: Inclusion Criteria:

* chronic pulmonary disease
* employed
* periods of sickness absence in the year prior to admittance

Exclusion Criteria:

* lack of ability to complete the rehabilitation program

Primary outcomes:
measure: Number of subjects absent from work more than 10 days 4 weeks prior to follow-up
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hakadal
country: Norway
facility: Glittreklinikken
state: Akershus
Study officials:
affiliation: LHL Helse
name: Morten S Ryg, PhD
role: STUDY_DIRECTOR
References: