louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00672607: a Clinical Trial to Evaluate the Efficacy and Safety of Agnucaston Tablets in the Treatment of Premenstrual Syndrome (PMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premenstrual Syndrome
Keywords: premenstual syndrome, PMS, clinical trial
Lead sponsor: Schwabe-Wenex International Ltd
Sponsor class: INDUSTRY
First posted: 2008-05-06
Enrollment: 217
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and safety of Agnucaston tablets with placebo for the treatment of Premenstrual Syndrome (PMS) and assess if Agnucaston tablets are superior to placebo on efficacy or not.

Detailed description: Premenstrual syndrome (PMS) is a common disorder in women and consists of somatic and/or behavioral/mood symptoms, which can impair a woman's social and work-related functioning. Some clinical studies with preparations containing Vitex agnus castus have demonstrated a positive effect on PMS with good tolerability. The aim of this clinical trial is to investigate the efficacy and safety of Agnucaston tablets for the therapy of PMS.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of PMS disease
* Age between 18 and 45 years
* Patients is in general good health

Exclusion Criteria:

* Any of the following endocrinological diseases: diabetes mellitus, hypo-/hyperthyreosis, pituitary tumor.
* Clearly kidney or liver disease, abnormal kidney or liver function.
* Any of the following gynecological diseases: endometriosis, mammary carcinoma, intraductal papilloma, galactorrhea, mammary fibroadenoma.
* Prior to the start of the study any planned surgical intervention of the breasts (including cyst puncture), of the uterus and/ or adnexa.

Primary outcomes:
measure: Change from baseline (cycle 0) of premenstrual complaints, assessed by the sum score of the 18 items of the PMS-Diary, after 3 cycles under treatment, evaluated for the luteal phase, i.e. the last 7 days prior a menstrual bleeding.
timeFrame: the last 7 days prior a menstrual bleeding
Secondary outcomes:
measure: Change from baseline (cycle 0) of the sum score of the 36 questions of the PMTS self-assessment scale after 3 cycles under treatment.
timeFrame: on the 1st-3nd day of menstrual bleeding
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT03777007: A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement
Official title: A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Joint Replacement Surgery
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: SPARTA force plate is used as rehabilitation tool in this study. The device is Force Plate coupled with SPARTA scan software that enables quick assessment of individual movement and balance within minutes. The magnitude as well as efficiency of force production is analyzed to determine an patient recovery graph.

Detailed description: The investigator hope to learn co-relation between the rehab tool and clinical findings and analyse association if any. In this study, force plate is rehab tool, which will optimize care according to the patient's specific needs and provided insights to patients length of stay in the hospital. these data driven insights will be used to observe correlation between machine and clinic data

Eligibility criteria: Inclusion Criteria:

* Patient scheduled for Primary unilateral total joint replacement
* Patient age should be more than or equal to 18 years.
* Patient must speak English

Exclusion Criteria:

* Patients undergoing bilateral primary knee replacement surgery
* Patients undergoing revision knee replacement surgery
* No uncorrectable deformity
* No deformity greater than 15 degree
* No hip arthritis
* No wheelchair dependency

Patients not willing and capable to sign the written informed consent

Primary outcomes:
measure: Length of Stay in Hospital Through Discharge
timeFrame: Up to 8 days
Secondary outcomes:
measure: Gait Aid Use
timeFrame: Preoperative and month 3 post-surgery
measure: Knee Society Score (KSS)
timeFrame: Month 3 post-surgery
measure: Range of Motion
timeFrame: Preoperative and month 3 post-surgery
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Derek Amanatullah, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04867707: Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes
Official title: Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: endothelial dysfunction
vascular function
glycocalyx integrity assessment
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 14
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group design with 20 subjects
Primary purpose: TREATMENT

Brief summary: The objective is to determine if neuraminidase inhibition with zanamivir is efficacious as a therapeutic strategy to restore endothelial function in T2D patients.

Detailed description: Twenty subjects will complete five days of treatment with zanamivir. Baseline measurements will be taken before the initiation of treatment, as well as after the conclusion of the treatment period (i.e., a total of two assessment visits per subject). Assessment visits will include: vitals (such as blood pressure, heart rate), fasting blood work for plasma neuraminidase activity, plasma sialic acid, plasma glucose and plasma insulin, brachial artery FMD, and glycocalyx integrity assessment via Glycocheck.

Eligibility criteria: Inclusion Criteria:

1. Men and women with a BMI of 25-39 kg/m2
2. Ages 45-64 years at randomization.
3. Diagnosis of T2D classified based on physician diagnosis.
4. No vulnerable populations (e.g., prisoners, pregnant, children) will be enrolled.

Exclusion Criteria:

1. Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke
2. History of chronic renal or hepatic disease
3. Active cancer
4. Autoimmune diseases
5. Immunosuppressant therapy
6. Hormone replacement therapy
7. Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women)
8. Current tobacco use
9. Pregnancy (Premenopausal women will be required to complete a urine pregnancy test before participation)
10. History of asthma or chronic obstructive pulmonary disease.
11. History of allergic reaction to lactose or milk proteins
12. Intranasal live attenuated influenza vaccine (LAIV) given within 2 weeks before zanamivir administration or a planned dose within 48 hours after zanamivir administration. Product insert states to avoid zanamivir administration with intranasal live attenuated influenza vaccine (LAIV).

Primary outcomes:
measure: Change in Glycocalyx Integrity-Perfused Boundary Region
timeFrame: Day 0 and Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri, School of Medicine Clinical Research Center
state: Missouri
Study officials:
affiliation: University of Missouri, School of Medicine
name: Luis Martinez-Lemus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06943807: Fecal DNA Methylation Detection for Gastric Cancer
Official title: Research on the Application of Fecal DNA Methylation Detection in the Early Diagnosis and Screening of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastric Adenocarcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 10800
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects for this clinical study were obtained from inpatients and outpatient follow-up patients attending the two sub-centers. Subjects were identified by the investigator based on subject enrollment criteria and informed of the contents of the informed consent form.

Brief summary: The study is a prospective, multicentre, cross-sectional study to evaluate the efficacy of fecal methylation-based testing in comparison with the 'gold standard' imaging tests, such as CT, gastroscopy and/or pathology, for the prediction of gastric cancer in an enrolled population.

Detailed description: Aims of the study Primary study aim: To assess the sensitivity and specificity of fecal methylation site-based tests for the prediction of gastric cancer.

Secondary research objectives: 1. the accuracy, kappa value, area under the ROC curve, positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value of fecal methylation locus test for the prediction of gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumour markers, such as CA19-9, CEA, and CA72-4, etc.; 3. The predictive ability of the combined fecal H. pylori gastric cancer susceptibility test was assessed.

Study design Prospective, multicentre, cross-sectional study. Study period 2 years from the start of the project as approved by the Institutional Ethics Committee.

Target population The target population is over 40 years old in areas with a high incidence of gastric cancer.

Sample size The sample size of this study should not be less than 10,800 cases.

Eligibility criteria: Inclusion Criteria:

* Age ≥40 years, male or female.
* Have or will have gastroscopy and/or pathology results.
* No contraindications to endoscopy and able to cooperate with endoscopy.
* Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.

Exclusion Criteria:

* Have severe cardiac, hepatic, or renal insufficiency, or mental disorders.
* Previous history of upper gastrointestinal malignancy.
* Women during pregnancy.
* Those with unspecified pathology.

Primary outcomes:
measure: Sensitivity and specificity of fecal DNA methylation testing based on its application for early diagnosis and screening of gastric cancer.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02219607: Liver Enzymes and Fluid Balance Following Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fluid Balance
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing colorectal surgery

Brief summary: The use of epidural anesthesia and postoperative analgesia influences fluid balance following colorectal surgery.

Markers such as BNP (brain natriuretic peptide) and liver function enzymes can estimate intravascular fluid load and predict outcome after colorectal surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing colorectal surgery

Exclusion Criteria:

* Severe cardiac failure Severe renal failure Severe liver failure

Primary outcomes:
measure: Change in liver enzymes
timeFrame: 5 days postoperatively
Secondary outcomes:
measure: Change in BNP (brain natriuretic peptide)
timeFrame: 5 days
Other outcomes:
Locations:
city: Chaidari
country: Greece
facility: Attikon Hospital
Study officials:
References:
Clinical trial NCT01286207: Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)
Official title: Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Protocols 022, 025, 029)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorders
Keywords: Migraine headache
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-01-31
Enrollment: 1959
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949); MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and migraine recurrence.


Eligibility criteria: Inclusion Criteria:

* Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029
* History of migraine headache

Primary outcomes:
measure: Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug
timeFrame: 2 hours after initial dose of test drug
measure: Number of Participants With Serious Clinical Adverse Experiences
timeFrame: Up to 12 months
measure: Number of Participants With Drug-related Clinical Adverse Experiences
timeFrame: Up to 12 months
measure: Number of Participants Who Discontinued Due to Clinical Adverse Experiences
timeFrame: Up to 12 months
measure: Number of Participants With Drug-related Lab Adverse Experiences
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01760707: Exercise Capability and Training Effects in Diabetic Patients With Neuropathy
Official title: Exercise Capability and Training Effects in Diabetic Patients With Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Peripheral Neuropathy
Keywords: Diabetes mellitus
Peripheral neuropathy
Exercise
Balance performance
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to investigate the effects of training on the exercise capability, balance performance, and microcirculation. Furthermore, to search the possible underlying mechanisms.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes with neuropathy.

Exclusion Criteria:

* Central nerve system dysfunction, hemiparesis, motion tremor, other musculoskeletal disease that might effect the outcome measurements.

Primary outcomes:
measure: Exercise capacity
timeFrame: 8 weeks
Secondary outcomes:
measure: maximal oxygen pulse
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ying-Tai Wu, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06603207: Study of the Causal Link Between Rheumatoid Arthritis and Periodontitis Using Mendelian Randomization
Official title: Causal Association Between Rheumatoid Arthritis and Periodontitis: A Mendelian Randomization Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rheumatoid Arthritis
Periodontitis
Keywords: Mendelian Randomization
Genome-Wide Association Study (GWAS)
Inflammatory Diseases
Genetic Risk Factors
SNP (Single Nucleotide Polymorphism)
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: Zhongshan People's Hospital, Guangdong, China
First posted: 2024-09-19
Enrollment: 220000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study utilizes genetic data from an East Asian population, sourced from publicly available genome-wide association studies (GWAS) focused on rheumatoid arthritis and periodontitis.

Brief summary: This study aims to investigate the causal relationship between rheumatoid arthritis and periodontitis using Mendelian randomization. Data will be sourced from genome-wide association studies (GWAS) to explore genetic associations and assess potential risk factors in an East Asian population.

Detailed description: The purpose of this study is to explore the causal association between rheumatoid arthritis (RA) and periodontitis using Mendelian randomization (MR). RA and periodontitis share similar inflammatory pathways and immune responses, but their causal relationship remains unclear. This study will utilize genome-wide association studies (GWAS) data from an East Asian population to identify single nucleotide polymorphisms (SNPs) associated with RA and assess their potential impact on the risk of developing periodontitis. Statistical methods such as inverse-variance weighting, MR-Egger regression, and weighted median analysis will be employed to analyze the data. The findings may provide insights into the shared genetic basis and causal relationships between these two conditions, offering potential targets for preventive strategies.

Eligibility criteria: Inclusion Criteria:

* Participants included in the genome-wide association study (GWAS) database.
* Subjects with available genotypic data relevant to rheumatoid arthritis and periodontitis.

Exclusion Criteria:

* Individuals without complete genotypic data or those with missing critical phenotypic information.

Primary outcomes:
measure: Causal Association Between Rheumatoid Arthritis and Periodontitis
timeFrame: Data collected from 2023 to 2024.
Secondary outcomes:
measure: Analysis of Genetic Pleiotropy and Confounders
timeFrame: 2023 to 2024
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00005107: Role of Nitric Oxide in Cirrhosis: Relationship With Systemic Hemodynamics, Renal Function, Vasoactive Systems and Endotoxemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cirrhosis
Liver Cirrhosis
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-04-12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: This study is to determine whether a compound, nitric oxide, made within the body, is the factor responsible for the changes in blood pressure and renal (kidney) functions that may occur during the course of cirrhosis. Patients with cirrhosis (liver scarring which causes poor liver function) will be eligible to participate. A group of healthy subjects will also be studied to compare the effects of the treatment to patients with cirrhosis and to confirm safety. A total number of 30 patients with cirrhosis and 10 healthy subjects will be enrolled in the study.

Detailed description: Upon admission, the patients will be physically examined and started on a special diet that will continue throughout the study. During the first four days of the study, the weight, heart rate and blood pressure of the patients will be measured every morning and 24-hour urine will be collected. On day 5, intravenous lines will be inserted in the patient's arms. One line will be used to draw blood samples and the other line will be used to infuse medications. Blood samples will be taken to measure liver and kidney function, nitric oxide, and other hormones that participate in the regulation of body fluids and blood pressure. Inulin and paraaminohippurate infusions (substances used routinely in the study of kidney function) will be started and blood and urine samples will then be taken at periodic intervals. Ninety minutes after the initiation of inulin and PAH infusions, L-NMMA (an investigational drug expected to increase the blood pressure and improve the kidney functions) will be infused. Blood and urine samples will be collected every 30 minutes. These procedures will take 4 hours. A total amount of about 10 tablespoons of blood will be drawn during the study. The patients will be discharged from the GCRC the next morning and restarted on their regular medications.

Eligibility criteria: Inclusion Criteria:

* Patients with compensated cirrhosis without previous history of ascites or edema
* Cirrhotic patient with ascites without renal failure
* Cirrhotic patients with ascites with functional renal failure
* Age and sex-matched healthy subjects

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: 4200 E. Ninth Ave., Box C281
state: Colorado
Study officials:
References:
Clinical trial NCT00382707: Transcranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology.
Official title: Transcranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Frontal Lobe Epilepsy
Keywords: repetitive transcranial magnetic stimulation
low frequency
frontal lobe epilepsy
brain excitability
electromyography
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-09-29
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Epileptic disease is characterised by enhanced brain excitability. Low frequency repetitive transcranial magnetic stimulation (rTMS) can be an effective treatment for refractory frontal epilepsy. Thought, physiological mechanisms of its effectivity are still unknown. It is yet possible to evaluate cortical excitability and inhibition with TMS-coupled electromyography before and after rTMS sessions ; this could provide clues for basic mechanisms of rTMS effects on the epileptic brain. We assume that rTMS decrease brain excitability by improving brain inhibition. Such an information could help for treating patients with both pharmacological and non-pharmacological methods.


Eligibility criteria: Inclusion Criteria:

* Cryptogenic frontal lobe epilepsy
* Normal cerebral MRI

Primary outcomes:
measure: Electrophysiological parameters for cortical excitability measured just before and after rTMS, 4 hours later and 24 hours later.
Secondary outcomes:
measure: Clinical efficacity on seizure intensity and frequency.
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Département de Neurologie - Hôpital Civil
city: Strasbourg
country: France
facility: Institut de Physique Biologique
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Serge CHASSAGNON, MD
role: STUDY_DIRECTOR
References: