cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes Patients

This study is to evaluate safety and efficacy of ASP1941 after 24 week administration to diabetic patients.

Subjects will undergo the 6-week screening period before entering the 24-week treatment period and will receive ASP1941 before breakfast during the treatment period. All subjects will be followed for 4 weeks after study treatment is discontinued.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus patients
* Subject is only on a diet and exercise program or has received a single antihyperglycemic agent or two antihyperglycemic agents (excluding insulin) with low dose (≤50% of the maximum dose of each recommended dosage)
* Subject has a HbA1c value (JDS value) between 6.5% and 9.5% and the difference of HbA1c values (JDS value) within ± 1.0%
* BMI 20.0 - 45.0 kg/m2

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Subject has received insulin within 12 weeks (84 days) before the study
* Subject has proliferative diabetic retinopathy
* Subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant
* Subject with obvious dysuria caused by a neurogenic bladder or a benign prostatic hypertrophy
* Subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and heart disease (NYHA Class III-IV) within 12 weeks (84 days). Subject has heart disease, cerebral vascular disease which, in the opinion of the principal investigator or the sub-investigator, may interfere with treatment or evaluation of safety of this study.
* Female subject who is currently pregnant or lactating, or who is possibly pregnant
* Male and pre-menopausal Female subject who cannot use an appropriate contraception during the study
* Subject has a history of treatment with ASP1941
* Subject has participated in another clinical study, post marketing study, or medical equipment study within 12 weeks (84 days) before providing written informed consent, or who is currently participating in any of those studies
* Subject has a serum creatinine value higher than upper limit of normal range
* Subject has a urinary microalbumin/ urinary creatinine ratio \> 300 mg/g in urinalysis
* Subject has uncontrolled severe hypertension (subject whose systolic blood pressure is \> 170 mmHg or diastolic blood pressure of \> 95 mmHg measured in a sitting position after 5 minutes of rest
* Subject who is judged inappropriate for enrollment into the study by the principal investigator or the sub-investigator
The Glaucoma and Retinopathy Screening Study

The goal of this clinical trial is to learn if a new screening approach including an artificial intelligence algorithm that analyzes fundus photographs, measurement of eye pressure and visual field testing works to screen for glaucoma.

Participants will:

Have an image of their fundus (back of the eye) taken as part of their diabetic eye screening Have a measurement of their eye pressure If needed, have a test of their side vision using a headset

Study Overview: This study is a prospective, interventional clinical trial designed to evaluate the effectiveness of an artificial intelligence (AI)-based screening program within community health settings. This study targets especially diabetic patients because they have higher risks of developing glaucoma. By integrating glaucoma screening into existing diabetic eye disease (DED) screenings, the study aims to identify cases of glaucoma earlier, thereby preventing or delaying progression to blindness.

Background: Glaucoma is a chronic eye disease that causes progressive optic nerve damage, often leading to irreversible vision loss. Early detection is critical, as glaucoma is typically asymptomatic in its early stages. Individuals with diabetes are at an elevated risk for glaucoma, making it crucial to develop accessible screening methods. Current DED screening programs already utilize fundus photography for diabetic retinopathy. Adding glaucoma screening to these existing DED screenings may provide an efficient and cost-effective solution to reach high-risk populations without requiring additional clinic visits.

Study Hypothesis: The hypothesis of this study is that incorporating AI-driven glaucoma screening into standard DED screenings will increase the detection rate of glaucoma in high-risk populations compared to DED screening alone. This combined approach is expected to yield better clinical outcomes by enabling early diagnosis and treatment while being cost-effective.

Expected Outcomes and Impact: This study is expected to provide valuable insights into the effectiveness of integrating AI-based glaucoma screening into existing screening programs for diabetic eye disease. If successful, this combined screening approach could be a cost-effective model for other community health settings, leading to earlier detection of glaucoma and improved patient outcomes. By making glaucoma screening more accessible the study aims to reduce health disparities and support preventive eye care.

Eligibility Criteria:
* Individuals with diabetes undergoing AI-based screening for diabetic retinopathy using the LumineticsCore (Digital Diagnostics) system for clinical care at primary care centers.
* Individuals who are able and willing to provide informed consent for participation in the study.
Magnetic Resonance Imaging (MRI) Hysterosalpingography Versus Radiographic Hysterosalpingography in Female Infertility

The main objective of this study is to compare the data of Hystérosalpingo-MRI with intra cavitary injection of diluted gadolinium salts with the classic hysterography, which allows to realize at once with no irradiating examination, a complete assessment of the female infertility.

Infertility is a disease which affects around 15% of couples (one union of seven) and has been increasing for 10 years. Therefore, and due to the development of methods of medically assisted procreation, demand for infertility evaluation is steadily increasing.

The infertility evaluation always begins with an accurate history, coupled with a physical examination of both partners. Indeed, infertility of a couple is due to the female partner in about two thirds of cases, the male partner in the remaining third of cases. In women, the main observed causes are ovulatory function disorders (10 to 20%), tubal causes by proximal or distal occlusion (10%), uterine causes involving intra-uterine synechiae, leiomyomas, adenomyosis, mucosal polyps (5 %), inadequate cervical mucus or cervical stenosis , and peritoneal causes such as endometriosis and post-infectious or post-surgical peritubo-ovarian adhesions (20 %).

Medical imaging is one of the key methods to identify the different etiologies in men as in women. It will serve to clarify the etiology in question and assess the likelihood of subsequent pregnancy. The initial imaging assessment for infertility in any woman includes an endovaginal ultrasound examination and a hysterosalpingography (HSG) . The use of MRI is considered as a second line in the absence of definitive diagnosis or to establish a definitive diagnosis before considering a targeted therapy. Indeed the performance of MRI for the diagnosis of pelvic endometriosis or fibroids mapping are well established.

HSG is the imaging technique of choice to evaluate the morphology of the uterine cavity and tubal patency. But it has several important limitations. Firstly it is an imaging method that uses x-rays and therefore delivers irradiation to the gynecological organs. Moreover, it does not allow a precise exploration of the entire abdomen and pelvis: therefore, the physician cannot have a complete assessment of the etiologies of infertility with HSG. Finally, it has a very good specificity but a relatively low sensitivity.

Eligibility Criteria:
Inclusion Criteria:

Patient who a pelvic MRI and an Hysterography, part of an infertility assessment, have been prescribed by a gynecologist physician in Nice University Hospital.

Informed consent signed Patient with social insurance Age \> 18

Exclusion Criteria:

Contraindication to magnetic resonance imaging hysterosalpingography Contraindication to radiographic hysterosalpingography
Acceptance and Commitment Therapy (ACT) Adapted for Women With Infertility-related Distress

This RCT will test the effect of a 7-week self-help ACT-based program in improving fertility-related quality of life and psychological flexibility, in women with infertility.

Ninety women with infertility living in Canada and the United States will be recruited. They will be emailed seven weekly 15-minute videos, each providing instructions on a new Acceptance and Commitment Therapy-based technique that addresses the impact of infertility on psychological inflexibility and distress. Fertility-related quality of life and psychological flexibility will be measured before and after the program. Outcomes will also be measured at one-month follow-up. Feedback about how to improve the program will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Has been trying to get pregnant for 12+ months and has failed OR is currently undergoing fertility treatments
* Lives in Canada or the United States
* Reports a high level of distress related to infertility, as indicated by a FertiQoL score below 71

Exclusion Criteria:

* Is currently experiencing active suicidal ideation, as indicated by a score of 7 or above on the Suicide Behaviours Questionnaire - Revised (SBQ-R)
Relation Between Mean Pulmonary Artery Pressure and Pulmonary Acceleration Time and Comparison With Previous Formulae

Since the pulmonary artery hypertension is defined based on MPAP and the two previous formulae relating MPAP and PAT were derived in western population, the investigator planned to conduct a prospective study to derive a new formula for measuring MPAP from PAT in Indian population and compare the accuracy of all the three formulae

After obtaining ethics committee approval and informed patient consent, minimum 25 patients \> 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure will be enrolled in this study.The demographics and the preoperative echocardiographic measurement will be noted. In the operating room, once the intravenous access is obtained, central venous catheterisation and pulmonary artery catheterisation will be done as per the institutional protocol. Once the Transthoracic echocardiogram (TTE) is performed patient will be induced with opioids, intravenous or inhalational agents, and muscle relaxant according to the patient clinical and hemodynamic condition. Once the patient airway is secured with tracheal tube, transesophageal echocardiogram (TEE) will be performed before and after bypass, which is routine in all patients undergoing cardiac surgery in the institution. Echocardiographic images will be analysed by two separate echocardiographers to detect inter-individual variability. Patient blood pressure and heart rate will be maintained within 20% of their baseline value throughout surgery. Based on the patient condition at the end of surgery, extubation will be done in the operating room or in intensive care unit (ICU) after a period of elective ventilation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure

Exclusion Criteria:

* Patients with known right ventricular outflow tract obstruction, intra-cardiac shunt lesions will be excluded
Idiopathic Pulmonary Fibrosis Registry for Future Studies

To establish a registry of patients for future studies of Inflammation in Interstitial Lung Disease/Idiopathic Pulmonary Fibrosis.

To establish a framework in which biologic samples and physiologic measures from patients with IPF can be longitudinally collected and evaluated. Having a bank of samples that are correlated with physiologic measures that follow patients through their course will allow the following proposed studies as well as future investigations to be efficiently carried out.

Eligibility Criteria:
Inclusion Criteria:

* any patient referred to the Interstitial Lund Disease clinic who is undergoing evaluation and or treatment for a new diagnosis of ILD. This can include patients referred for presumed pulmonary fibrosis/interstitial pneumonitis (IPF, UIP, NSIP), sarcoidosis, hypersensitivity pneumonitis, cryptogenic organising pneumonia, drug-induced, or other idiopathic ILDs.

Exclusion Criteria:

* pregnancy
* inability to follow study requirements
Catechin Containing Mask for the Prevention of Influenza Infection

The purpose of this study is to evaluate the effects of catechin extracts containing mask on prevention of influenza infection.

Catechins are the major components of tea flavonoids and are reported to possess physiological activities such as antiviral effects. Recent in-vitro experimental studies have revealed that tea catechin extracts possess the effects on the prevention of influenza infection. However, a limited number of studies have been conducted on the clinical effects. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of tea catechin extracts containing mask on the prevention of influenza infection.

Eligibility Criteria:
Inclusion Criteria:

* Possible to wearing mask for three months
* Possible to fill out a questionnaire personally
* Obtained written informed consent before participation

Exclusion Criteria:

* Possessing some infectious diseases in need of therapy
* Possessing tea or catechin allergy
* diagnosed as inadequate for other reasons to participate the study by principal investigator
Penclomedine in Treating Patients With Solid Tumors or Lymphoma

Phase I trial to study the effectiveness of penclomedine in treating patients with malignant solid tumors or lymphomas. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) and Phase II dose of oral penclomedine in patients with malignancies.

II. Determine the toxic effects of oral penclomedine in these patients. III. Determine the pharmacokinetics of oral penclomedine in these patients. IV. Determine the bioavailability of oral penclomedine in these patients.

OUTLINE:

Patients enrolled on the bioavailability portion of this study receive one dose of IV penclomedine over 1 hour followed by 2 weeks of rest. At the end of two weeks, they receive oral penclomedine for 5 days every 28 days. The starting dose is determined by a single primary patient who has been administered oral penclomedine and observed for dose limiting toxicity (DLT). \[Bioavailability portion completed as of 3/98.\] Those not on the bioavailability portion of study start on a standard design dose escalating schedule in which patients enroll in cohorts of 3. Patients are administered oral penclomedine daily for 5 days. This treatment repeats every 4 weeks. The MTD is defined as the dose immediately below that at which 2 patients experience DLT. Treatment repeats for 6 courses or until severe toxicity or tumor progression is observed.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed malignancy (solid tumor or lymphoma)
* No history of brain metastases

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Life expectancy: At least 12 weeks
* Performance status: ECOG 0-2
* WBC at least 4,000/mm3
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Bilirubin less than 1.5 mg/dL
* Creatinine normal
* No history of seizure disorder Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas and mitomycin) and recovered
* At least 4 weeks since prior radiotherapy and recovered
A Study of CPTX2309 in Healthy Participants

The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants.

A first-in-human Phase 1, open label study to evaluate safety and tolerability of a single ascending dose (SAD) and multiple ascending dose (MAD) of CPTX2309 intravenously administered to healthy adult participants.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period.
* Participant is willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted.
* Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the first administration of CPTX2309.
* Note: Other protocol-defined inclusion/exclusion criteria apply
Fibrin Sealant in Esophageal Surgery

Anastomotic leakage remains a major complication after esophageal surgery. Amongst other preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic techniques. The investigators aimed to investigate feasibility of additional sealing by means of autologous fibrin sealant of the esophageal anastomosis.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 - 90 years
* Scheduled to undergo elective minimal invasive esophageal surgery with thoracic or cervical anastomosis (i.e. Ivor Lewis, Orringer or McKeown esophagectomy).
* physical status (American Society of Anesthesiologists) of 3 or lower

Exclusion Criteria:

* Other malignancies
* Previous esophageal surgery were excluded
A Study of Disease Progression in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

This study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration (AMD). The study also will generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 200 participants with GA secondary to AMD. The study visits are scheduled to occur every 6 months. The anticipated duration of the study is up to 60 months.


Eligibility Criteria:
Inclusion Criteria:

* Well-demarcated area of GA secondary to AMD
* Women of childbearing potential and men must agree to use adequate contraception for at least 30 days after fluorescein dye administration
* The study is recruiting participants in two different cohorts:

Cohort 1: Participants with unilateral GA OR Cohort 2: Participants with GA in one eye and CNV (active or treated) with or without GA, in the contralateral eye

Exclusion Criteria:

* Previous participation in any studies of investigational drugs for GA / dry AMD (exception for studies of vitamins and minerals)
* GA in either eye due to causes other than AMD
* History of vitrectomy surgery, submacular surgery, or any surgical intervention for AMD
* Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and/or proliferative diabetic retinopathy
* Any ocular/systemic medical conditions that, in the opinion of the investigator, could contribute to participant's inability to participate in the study or interfere with study assessments.
* Requirement for continuous use of therapy indicated in Prohibited Therapy
An Extension of CTN 31GB0607 to Evaluate Long Term Safety of NASHA Treatment in the Breast

The study evaluates degradation of NASHA in breast 4 and 6 years post treatment, long term safety and evaluation if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast. An independent evaluation of the aesthetic changes is also performed.


Eligibility Criteria:
Inclusion Criteria:

* subject treated with NASHA-gel in the breasts in study 31GB0607
* signed informed consent

Exclusion Criteria:

* no exclusion criteria in this study
Clinical Study, Multicenter, Randomized With 2 Arms of Pantoprazole + Domperidone and Pantoprazole Isolated at the Gastroesophageal Reflux Disease

This superiority phase III study to compare the combination of Pantoprazole and Domperidone with Pantoprazole isolated to the treatment of gastroesophageal reflux disease. The hypothesis is that combination of the two medication at the unique capsule is better to the patients because decrease the quantity of times the patients need to take medicines during the day.


Eligibility Criteria:
Inclusion Criteria:

1. Subscription of IC;
2. Age ≥ 18 years and \<70 years
3. Diagnosis initial clinical or previous symptomatic GERD;
4. Symptom score ≥ 4;
5. Ability to conduct examinations of endoscopy;
6. Ability to perform washout of drug classes PPIs, H2 antagonists, and prokinetics for at least 14 days.

Exclusion Criteria:

1. Presence of esophagitis requiring intervention, esophageal varices, Barrett's esophagus, scleroderma, ulcers (gastric or duodenal), atrophic gastritis, or vagotomy pangastritis detected at the time of study enrollment;
2. Eradication treatment of H. pylori completed less than 15 days of V0;
3. Presence of alarm symptoms (weight loss greater than 5% in the last 60 days, no evidence of gastrointestinal bleeding);
4. Gastric or esophageal surgery prior (except for simple ulcer closure);
5. Females in pregnancy, lactation, or who wish to become pregnant if they refuse to use adequate contraception during the study period.
6. Concomitant serious diseases such as kidney failure, heart and liver;
7. Suspected or confirmed any cancer except carcinoma in situ or nonmelanoma skin cancer diagnosed in the last 5 years;
8. History of gastric cancer in relatives of 1st degree;
9. Use of illicit drugs or alcohol abuse according to the investigator;
10. Values changed (outside the normal range for the local laboratory) in leukocytes, platelets or hemoglobin;
11. Significant changes in serum sodium, potassium, calcium or creatinine;
12. Intolerance or allergy to any component of the drugs evaluated in the study;
13. Use of anti-inflammatory drugs (NSAIDs), antiemetics, macrolides and systemic steroids for a period of not less than 2 weeks prior to the study or who have expected necessity of prolonged use during the study treatment;
14. Current use of bisphosphonates, as well as those who need calcium channel blockers or other drugs that affect esophageal motility or lower esophageal sphincter tone.
15. Use of other scheduled medications metabolized by cytochrome CYP3A4 during the study;
16. Participation recent (past 12 months) or participation in a clinical trial expected during this study in other clinical trials involving drugs of any kind.