louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07025798: The Impact of Compound Probiotic Freeze-dried Powder on Enhancing Gastrointestinal Health
Official title: The Impact of Compound Probiotic Freeze-dried Powder on Enhancing Gastrointestinal Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tract
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the effects of the compound probiotic freeze-dried powder on gastrointestinal function and its impact on gut microbiota, immune factors, inflammatory markers, and intestinal barrier function.


Eligibility criteria: Inclusion Criteria:

（1）Age: 18-65; （2）It conforms to the diagnostic criteria for gastrointestinal dysfunction formulated in the "Expert Consensus on Precision Health Communication in China - Guidelines for Citizens' Intestinal Health"; （3）Symptoms: Irregular defecation, loose or hard stools; Intestinal rumbling in the abdomen Abdominal distension Hiccups, belching; Severe intestinal flatulence; Abdominal pain Acid reflux and heartburn; Pain in the stomach or abdomen when hungry; Disgusting; (4) Signs: Abdominal pain and abdominal distension; Diarrhea and constipation Indigestion Gastric acid reflux Bad breath and farting smell; Skin problems The color and shape of the stool have changed.

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Exclusion Criteria:

(1)Drugs that affect the intestinal flora (including antibacterial drugs, microecological preparations, intestinal mucosal protectants, traditional Chinese patent medicines, etc.) should be used continuously for more than one week within one month before screening; （2）Recent use of products with similar functions to the test product, which may interfere with the judgment of the study results; (3) use of antibiotics during illness; (3)Use of antibiotics during illness; (4)Resence of severe systemic diseases or malignant tumors; (5)allergy to any components of the probiotics used in the study; (6)women who are pregnant, breastfeeding, or planning to conceive in the near future.

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Primary outcomes:
measure: Improvement of gastrointestinal symptoms
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Luoyang
country: China
facility: School of Food and Bioengineering, Henan University of Science and Technology
state: Henan
Study officials:
References:
Clinical trial NCT06457698: Temporomandibular Bioviscosuplementation (Platelet-Rich Plasma Combined With Hyaluronic Acid) After Double-Puncture Arthrocentesis: a Randomized Controlled Trial
Official title: Temporomandibular Bioviscosuplementation (Platelet-Rich Plasma Combined With Hyaluronic Acid) After Double-Puncture Arthrocentesis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: Hyaluronic acid
platelet-rich plasma
arthrocentesis
viscosuplementation
Lead sponsor: Instituto Portugues da Face
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 50
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: Intra-articular injections of hyaluronic acid (HA) or platelet-rich plasma (PRP) have been used with temporomandibular joint (TMJ) arthrocentesis to improve lubricative properties and influence regenerative processes. A randomized, controlled clinical trial investigated the benefits of complementary bioviscosuplementation (HA+PRP) in patients submitted to double-portal TMJ arthrocentesis.


Eligibility criteria: Inclusion Criteria:

* (1) age \>18 years; (2) history of conservative treatment for TMD without significant improvement for at least three months; (3) clinical diagnosis of unilateral or bilateral intra-articular disorder; (3) clinical criteria for unilateral or bilateral TMJ arthrocentesis; (4) magnetic resonance imaging (MRI) and computed tomography (CT) documenting arthrogenous derangement.

Exclusion Criteria:

* The exclusion criteria included: 1) any history of previous TMJ surgical intervention or any facial trauma within the last 4 weeks before the study; 2) concomitant other contralateral TMJ surgery; 3) severe medical problems or mental illness and pregnancy.

Primary outcomes:
measure: TMJ arthralgia (VAS, 0-10)
timeFrame: TMJ arthralgia will be assessed preoperatively (T0) and postoperatively (T1 - 1 month, T2 - 3 months, T3 - 6 months, T4 - 12 months follow-up).
Secondary outcomes:
measure: maximum mouth opening (MMO)
timeFrame: MMO will be assessed preoperatively (T0) and postoperatively (T1 - 1 month, T2 - 3 months, T3 - 6 months, T4 - 12 months follow-up).
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Instituto Português da Face
Study officials:
References:
Clinical trial NCT04300998: Study of CAR-T Therapy in Older Patients
Official title: Observational Study of Commercial Chimeric Antigen Receptor T-cell (CAR T) Therapy in Older Patients With Hematologic Malignancies and With an Embedded Pilot Study of Longitudinal Geriatric and Neurocognitive Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Refractory B-Cell Lymphoma
Lymphoma, B-Cell
DLBCL NOS
High-grade B-cell Lymphoma
Multiple Myeloma
Keywords: Lymphoma
CART therapy
relapsed refractory large B-cell lymphoma
High-grade B-cell Lymphoma
DLBCL NOS
Refractory B-Cell Lymphoma
19-452
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 154
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be recruited from all oncologists and all transplant physicians at the Memorial Sloan Kettering Cancer Center. Patients are recruited without consideration of gender, country of origin, educational level, or income. There will be no reimbursement or payment toward the participation of this study.

Brief summary: This study is being done to find out how older patients respond to CAR-T cell therapy and how the treatment affects their quality of life. This is a quality of life study and participating in the study does not involve receiving any treatment, other than the standard treatment for participants' disease.


Eligibility criteria: Inclusion Criteria:

* are ≥60 years old (all cohorts)
* have pathologically confirmed, relapsed refractory lymphoid malignancy or plasma cell disorder receiving a commercial CAR T-cell product (all cohorts)
* able to speak and understand English (cohort 1 and 4 only)
* have a MoCA score of less than 26 out of 30 during the GA visit by a geriatrician prior to CAR T-cell treatment (cohort 4 only)

Exclusion Criteria:

* Any prior commercial or investigational CAR T therapy (all cohorts)
* Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report (cohort 1 only)
* History of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (\>60 minutes), as per medical records or patient report (cohort 1 only)
* Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report (cohort 1 only)
* History of CNS disease (cohort 4 only)

Primary outcomes:
measure: Number of participants who complete all required assessment visits prior to disease progression or death
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Richard Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06595498: Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients with Lung Cancer
Official title: Evaluation of an Ultrasensitive Next Generation Sequencing Method for the Detection of EGFR Gene Mutations in the Plasma of Patients with Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carcinoma, Non-small Cell Lung Cancer (NSCLC)
Keywords: lung cancer
non-small cell lung cancer
EGFR mutation
Next Generation Sequencing
plasma
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to evaluate the Plasma-SeqSensei™ Solid Cancer IVD Kit NGS diagnostic test (Sysmex) before its introduction into routine diagnostics. This is a test for research of EGFR mutations in cfDNA that needs to be evaluated in a patient population with lung adenocarcinoma already characterized for EGFR mutations by a molecular test of reference. The proposed study does not present any risk to participants.


Eligibility criteria: Inclusion Criteria:

* Males or Females aged at least 18 years;
* Patients with advanced or metastatic non-small cell lung cancer at diagnosis or progression who have previously had the cobas® EGFR Mutation Test v2 (Roche) performed on a liquid biopsy with a valid result (positive or negative);
* Availability of 6 mL of plasma.

Exclusion Criteria:

* Plasma not available in sufficient quantities to perform both tests;
* Cobas test with invalid result.

Primary outcomes:
measure: Primary Outcome
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Secondary Outcome
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
Study officials:
References:
Clinical trial NCT06568198: Modulation Effect of tACS on Chronic Low Back Pain
Official title: Modulation Effect of Transcranial Alternating Current Stimulation (tACS) on Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2024-08-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Investigating the modulation effect of tACS

Detailed description: Investigating the modulation effect of one-month Transcranial alternating current stimulation (tACS) for low back pain

Eligibility criteria: Inclusion Criteria:

1. Volunteers 18-60 years of age
2. Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months)
3. At least 4/10 clinical pain on the 0-10 LBP NRS
4. At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures
5. Meeting the MRI / MEG / EEG screening criteria

Exclusion Criteria:

1. Specific causes of back pain (eg, cancer, fractures, spinal stenosis, infections)
2. Complicated back problems (eg, prior back surgery, medicolegal issues)
3. The intent to undergo surgery during the time of involvement in the study
4. History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome (for example: asthma or claustrophobia)
5. Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)
6. Concomitant autoimmune, chronic, inflammatory, neoplastic, and psychiatric diseases
7. Pregnant or lactating
8. Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)
9. Active substance abuse disorders (based on subject self-report and drug test)
10. Regular use of pain medication such as opioids, nonopioid analgesics, coanalgesics, corticosteroids, or immunomodulatory agents
11. Any medical conditions, such as peripheral neuropathy, that could affect the results of QST
12. Current use of psychotropic medication

Primary outcomes:
measure: thalamo-sensory-cortex connectivity
timeFrame: about one month, data will be collected at baseline and after one month treatment
Secondary outcomes:
measure: Low back pain intensity
timeFrame: about one month, data will be collected at baseline and after one month treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02714998: The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy
Official title: The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ectopic Pregnancy
Infertility
Keywords: ectopic pregnancy
ovarian reserve
salpingectomy
methotrexate
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to investigate the effects of salpingectomy and Methotrexate administration on ovarian reserve in ectopic pregnancy.

Detailed description: In this study, the effects of unilateral laparoscopic salpingectomy and single dose of systemic Methotrexate administration on ovarian reserve in patients diagnosed with ectopic pregnancy were investigated.

Eligibility criteria: Inclusion Criteria:

* ectopic pregnancy diagnosis

Exclusion Criteria:

* history of endometriosis, ovarian surgery, systemic chemotherapy, ART treatment.
* patients treated with multiple doses of methotrexate or different surgical procedure (salpingostomy, milking)

Primary outcomes:
measure: Ovarian reserve assessment by measuring AMH level.
timeFrame: 1-3 months
Secondary outcomes:
measure: Number of participants with treatment related adverse effect on fertility.
timeFrame: 2 years of follow up after treatment
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University School of Medicine Department of Obstetrics and Gynecology
Study officials:
affiliation: Ege University School of Medicine Department of Obstetrics and Gynecology
name: Ahmet M. Ergenoglu, Ass. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00660998: Evaluation of Efficacy and Safety of Vardenafil in Patients With Erectile Dysfunction and Type 1 Diabetes
Official title: A Rand, db, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Plac in Men With Diabetes Mellitus Type 1 and Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Diabetes mellitus type 1
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 318
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: Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction


Eligibility criteria: Inclusion Criteria:

* Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
* Diabetes type 1
* Stable sexual relationship for \> 6 month.

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy

Primary outcomes:
measure: Sexual Encounter Profile Question 2
timeFrame: 12 weeks
measure: Sexual Encounter Profile Question 3
timeFrame: 12 weeks
Secondary outcomes:
measure: International Index of Erectile Function - Erectile Function Domain
timeFrame: 12 weeks
measure: Safety and Tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06801145: Video-Assisted Training in the Intensive Care Process Focuses on the Intensive Care Experiences of Patients Who Will Undergo Open Heart Surgery and Effect on Anxiety Levels
Official title: Video-Assisted Training in the Intensive Care Process Focuses on the Intensive Care Experiences of Patients Who Will Undergo Open Heart Surgery and Effect on Anxiety Levels
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Open Heart Surgery
Keywords: BYPASS
OPEN HEART SUNGERY
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 110
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: SUPPORTIVE_CARE

Brief summary: The study will consist of experimental and control groups. Patients in the experimental group will be administered the Patient Introduction Form, Intensive Care Experience Scale and State Anxiety Scales before surgery. Then, video-supported training will be given about the intensive care process, and the State Anxiety Scale and Intensive Care Experience Scales will be re-administered to the patients 24 hours after the surgery. These scales will be administered to the patients in the control group without video-supported training. No intervention other than standard nursing care will be given to patients.

Detailed description: The study will consist of experimental and control groups. Patients in the experimental group will be administered the Patient Introduction Form, Intensive Care Experience Scale and State Anxiety Scales before surgery. Then, video-supported training will be given about the intensive care process, and the State Anxiety Scale and Intensive Care Experience Scales will be re-administered to the patients 24 hours after the surgery. These scales will be administered to the patients in the control group without video-supported training. No intervention other than standard nursing care will be given to patients. The study will have a sample size of 62: 31 experimental and 31 control groups.

Eligibility criteria: Inclusion Criteria:

* Those between the ages of 18-75,
* Those who agree to participate in the research and volunteer,
* No communication problems,
* Cognitive level scales are suitable for application,
* Patients without vision and hearing problems were included in the study.

Exclusion Criteria:

* Leaving work voluntarily,
* Patients whose cognitive level scales were not suitable for application were excluded from the study.

Primary outcomes:
measure: Intensive care experience scale
timeFrame: 1 day after arriving from intensive care care
measure: Situation Continuous Anxiety Scale
timeFrame: A week before surgery
measure: Situation Continuous Anxiety Scale
timeFrame: the 1 day before surgery
measure: Situation Continuous Anxiety Scale
timeFrame: 1 day after arriving from intensive care care
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05746598: Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Cisplatin Among Egyptian Non-small Cell Lung Cancer Patients
Official title: Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Cisplatin Among Egyptian Non-small Cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Nephropathy
Cardiotoxicity
Keywords: Non-small cell lung Cancer
Nephropathy
Cardiotoxicity
Gene polymorphism
Cisplatin
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Misr International University
First posted: 2023-02-28
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: • NSCLC cancer patients treated with Cisplatin-containing chemotherapy.

Brief summary: Lung cancer is the leading cause of death worldwide, with non-small-cell lung cancer (NSCLC) being the most common histotype according to the global cancer observatory 2022. A variety of therapeutic options for advanced/metastatic non-oncogene-addicted NSCLC have recently been approved based on their impact on patient outcomes in terms of survival and safety profile. Current guidelines advocate for personalized treatment options based on molecular and immunologic characteristics, which drives the physician's decision toward tailored oncology.

In the last two to three decades, hundreds of cancer biological prognostic markers for non-small cell lung cancer have been proposed. Although they have shown a potential in this ﬁeld, validation studies are still required and, to date, there is in suﬃcient evidence to recommend the routine clinical use of any of these putative biomarkers. Therefore, the discovery of robust prognostic and/or predictive biomarkers in patients with non-small cell lung cancer is imperative for advancing treatment strategies for the disease and improving patient care.


Eligibility criteria: Inclusion Criteria:

* NSCLC cancer patients treated with Cisplatin-containing chemotherapy.
* Measurable disease.
* Age of 18 years to 80 years.

Exclusion Criteria:

* Non-small cell lung cancer patients who had undergone radiotherapy or chemotherapy.
* Pregnant and lactating females.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin.
* Any other medical or psychiatric condition or severe or chronic laboratory abnormality making the inclusion of the patient in the study inappropriate in the opinion of the investigator.

Primary outcomes:
measure: Nephrotoxicity
timeFrame: 6 months
Secondary outcomes:
measure: Blood urea nitrogen
timeFrame: 6 months
measure: Serum creatinine
timeFrame: 6 month
measure: Cardiotoxicity
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: