cyrilzakka/clinical-trials huggingface dataset:
To Evaluate the Effectiveness of the Use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Anterior Talofibular Ligament Repair Surgery

The goal of this clinical trial is to evaluate the effectiveness of the use of a novel crosslinking hyaluronan hydrogel on the prevention of the adhesion occurrence after anterior talofibular ligament repair surgery. With applying crosslinking hyaluronan hydrogel, the range of motion (ROM) of the ankle is expected to be better than sham group.


Eligibility Criteria:
Inclusion Criteria:

1.1 Voluntarily participate and sign an informed consent form; 1.2 Age 18 to 60 years of male or female; 1.3 Patients experiencing lateral ankle pain discomfort, confirmed by MRI to have anterior talofibular ligament (ATFL) injury; 1.4 History of recurrent ankle inversion sprains three times or more, with no improvement after six months of conservative treatment, and scheduled for ATFL repair surgery; 1.5 Willing to comply with all follow-up requirements of the trial protocol.

Exclusion Criteria:

2.1 Severe ankle osteoarthritis; 2.2 Patients with a history of ankle fracture or surgery; 2.3 Undergoing foot- or ankle-related treatments that may affect the trial results; 2.4 Presence of skin infection, skin defects, or need for skin grafting at the surgical site; 2.5 Uncontrolled chronic diseases, such as diabetes mellitus; 2.6 Presence of autoimmune diseases (such as Autoimmune Collagenopathy, rheumatoid arthritis), malignancies, coagulation disorders, heart diseases, psychiatric illnesses, or other conditions that may pose higher risks to patients in the trial; 2.7 Use of corticosteroids within the past 6 months, systemic corticosteroids within the past month, immunosuppressive drugs within the past 3 months, or daily use of non-steroidal anti-inflammatory drugs (NSAIDs) within the past week, or occasional use within 8 hours (patients using nasal/inhaled corticosteroids may be considered for inclusion) ; 2.8 Clinically significant coagulation abnormalities or undergoing anticoagulant therapy within 10 days before surgery or currently taking anticoagulant drugs; 2.9 Known allergy to sodium hyaluronate or any components of medical devices;allergy to Gram-positive bacterial protein or streptococcal protein；or other severe allergic history deemed unsuitable for participation by the investigators; 2.10 Pregnant, lactating women, or women planning to become pregnant during the trial period; 2.11 Other conditions deemed unsuitable for participation by the investigators.
Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy

The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of POAG
* Medicated IOP ≥ 21 and ≤ 35 mmHg
* Use of 1 - 4 topical IOP lowering medications

Exclusion Criteria:

* Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
* Use of oral hypotensive medication treatment for glaucoma
* Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure
* Clinically significant ocular pathology other than POAG
Study on Recurrence Monitoring of Hepatocellular Carcinoma With 5-Hydroxymethylcytosine Test

In this study, investigators aim to find out how plasma 5hmC level changes in hepatocellular carcinoma patients after liver resection, and determine whether 5hmC can be used as a biomarker for HCC recurrence monitoring.

Hepatocellular carcinoma (HCC) is the most common primary liver cancer and the third leading cause of cancer-related death worldwide. Liver resection is a common treatment for HCC. However, even after successful surgical resection, most patients suffered from recurrence or progression of the tumor. Because clinical staging systems cannot precisely predict the outcome of patients with HCC, it's of great interest to search biomarkers for HCC. Among them, alpha-fetoprotein (AFP) is the most well-studied. However, the applicability of AFP for HCC after surgical resection of tumor is still uncertain.

The discovery of cell-free DNA (cfDNA) originating from different tissues in the circulating blood has revolutionary potential for the clinic. Liquid biopsy-based biomarkers and detection tools offer substantial advantages over existing diagnostic and prognostic methods, including being minimally invasive. They thus have a cost-efficient potential to promote higher patient compliance and clinical convenience to enable dynamic monitoring.

5-hydroxymethylcytosine (5hmC) is the intermediate of active demethylation from 5-methylcytosine. 5hmC not only marks active demethylation but also serves as a relatively stable DNA mark that plays distinct epigenetic roles. Recent genome-wide sequencing maps of 5hmC in various mammalian cells and tissues support its role as a marker for gene expression. Previous studies have established 5hmC-Seal technology for 5hmC profiling in cfDNA and showed that the differentially enriched 5hmC regions in cfDNA are excellent markers for solid tumors.

In this study, investigators aim to find out how plasma 5hmC profile changes in hepatocellular carcinoma patients after liver resection, and determine whether 5hmC can be used as a biomarker for HCC recurrence monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who received liver resection within 3 months;
2. Hepatocellular carcinoma confirmed pathologically;
3. Serum alpha-fetoprotein level lower than 20ng/ml before hepatectomy.

Exclusion Criteria:

1. Patients with macroscopic tumor remnants;
2. Patients with other diseases which may affect the observation mentioned here;
3. Patients with medical history of other malignant tumors;
4. Pregnant or nursing women.
Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

The objectives of this research study are to screen 750 pregnant women at risk of trauma-related stress symptoms, and adapt and test an evidence-based intervention for pregnant women with PTSD and sub-threshold PTSD symptoms served by two public payer community health centers.

Studies of Posttraumatic Stress Disorder (PTSD) in pregnant women in public payer settings have shown rates 5 or more times that of other populations, and rates as high as 33% of lifetime PTSD sub-threshold symptoms. PTSD during pregnancy has been linked to poor prenatal care and high risk behaviors such as drug and alcohol use and smoking. Further, PTSD may pose a barrier to care as obstetric procedures and pregnancy may trigger PTSD symptoms and avoidance of care. PTSD is also associated with pregnancy and birth complications and negative postpartum outcomes including excessive weight gain, preterm birth, low birth weight, risk for parenting problems, and increased barriers to breastfeeding. However, screening, identification, and support for PTSD is lacking. This study will screen 750 pregnant women at risk of trauma-related stress symptoms, and adapt and test an evidence-based intervention for pregnant women with PTSD and sub-threshold PTSD symptoms served by two public payer community health centers.

Eligibility Criteria:
Inclusion Criteria:

* Mothers who are receiving prenatal care
* 18 years or older
* In the first 20 weeks of pregnancy
* Screen positive for posttraumatic stress disorder

Exclusion Criteria:

* Not pregnant
* Not currently psychotic
* No current suicidal ideation
* Language other than English, Spanish, Vietnamese, and Portuguese
An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC

This is a multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with non-Gorlin HF-BCC (high-frequency basal cell carcinoma). Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender. The primary endpoint is the number of nSEB (surgically eligible basal cell carcinoma) that develop on the face over the 9 month period. The primary end point will be assessed by imaging and tracking of BCCs consistently throughout the study in order to identify nSEBs.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must have had at least 10 (with at least 3 on the face) clinically typical BCCs present within 24 months prior to Screening and Randomization (Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with longest diameter \<5 mm present on the face prior to Screening and Randomization (Baseline/Day 1).
2. The subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the Investigator.

Exclusion Criteria:

1. The subject has been previously diagnosed with Gorlin syndrome
2. On medical history, family history or clinical examination there is a suspicion that the patient has Gorlin syndrome.
3. Patients with a family history of medulloblastoma
4. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.
5. The subject has uncontrolled systemic disease.
6. The subject has been treated for invasive cancer within the past 5 years excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (CLL) Stage 0.
Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer

This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma

This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma.

Patients with resectable esophageal squamous cell carcinoma receive 2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). Patients who do not progress with distant metastases start preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gy for 4 weeks).

4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy irrespectively of objective response.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-75
2. Histologically or cytologically confirmed resectable squamous-cell Tumor (T)1-2 node (N)+, T3N0-3 esophageal cancer. Inclusion of patients with morphologically confirmed and potentially resectable supraclavicular lymphnodes (unilateral, less than 1,5 cm in short axis) is allowed
3. No prior antineoplastic treatment
4. Eastern Cooperative Oncology Group (ECOG) status 0-2
5. Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy

   * absolute neutrophil count ≥ 1,500 х109/l
   * thrombocytes ≥ 100 х 109/l
   * hemoglobin ≥ 90 mg/l
   * creatinine \< 115 µmol/л or creatinine clearance ≥ 55 ml/min
   * alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN)
   * alkaline phosphatase (ALP) \> 5 x ULN
   * bilirubin \> 1,5 х ULN
6. Women of childbearing potential must have negative pregnancy test, performed 7 days prior to initial treatment
7. Patients must follow appropriate contraception rules during whole treatment period
8. Decrease of body weight must not be more than 20% in last 6 months

Exclusion Criteria:

1. Presence of distant metastases except for metastatic supraclavicular lymphnodes;
2. Bulky (\>3 cm) regional lymphnodes metastases;
3. Cervical esophageal cancer;
4. Presence of tumor fistula;
5. Prior malignant tumor, except for proper treated skin basal cell carcinoma and in situ cervical cancer;
6. Active infectious diseases and concomitant diseases that can affect treatment tolerability, surgery and other study procedures;
Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy

The study will evaluate the dose response of immunotherapy against grass pollen allergy using the recombinant grass pollen vaccine BM32. Efficacy will be analyzed by:

* skin prick testing
* grass pollen inhalation challenge
* antibody responses. In addition, the safety of subcutaneous application of BM32 will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* History of seasonal allergic rhinitis from grass pollen
* Normal electrocardiogram
* Moderate to severe response to approx. 1500 grass pollen grains/m3 after 2 hrs of exposure in challenge chamber
* Positive skin prick test for grass pollen at or within 12 months preceding screening visit
* Positive RAST (class 2 or higher) for timothy grass pollen and to rPhl p 1 + rPhl p 5 at or within 12 months preceding screening visit

Exclusion Criteria:

* Pregnant or lactating females
* Females with childbearing potential not using medically acceptable birth control
* Structural nasal abnormalities, nasal polyposis, history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection
* Any respiratory disease other than mild asthma controlled with occasional short acting beta agonists and normal lung function
* Current or recent participation in another clinical trial
* SIT for grass pollen allergy in the last two years prior to study
* Past or present disease, which may affect outcome of the trial, judged by investigator
* Autoimmune diseases, immune defects including immunosuppression, immune- complex immunopathies
* Suspected hypersensitivity to any ingredients of study medication
* Use of prohibited medication prior to screening and throughout study
* depot corticosteroids (12 weeks)
* oral corticosteroids (8 weeks)
* inhaled corticosteroids (4 weeks)
* Allergic symptoms at the time of screening
Age-Related Macular Degeneration (AMD) - Usability Study

The purpose of this study is to evaluate the usability of the Foresee Home device with intermediate AMD patients.

The AMD usability study is a prospective, longitudinal, multi-center, observational study of patients diagnosed with intermediate (dry) AMD who have been asked by their doctor to use the ForeseeHomeTM device to record the natural progression of their AMD, including conversion from the dry to wet stage.

Eligibility Criteria:
Inclusion criteria

* Subjects diagnosed as intermediate AMD in at least one eye
* Visual Acuity (VA) with habitual correction \<20/60 in the study eye
* Qualified in the clinic to use the device
* Ability to speak, read and understand instructions in English
* Subjects with ability to comprehend and sign the informed consent/authorization

Exclusion criteria

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
Capitalizing on a Teachable Moment to Promote Smoking Cessation

The purpose of this study is to develop and test a self-help smoking cessation treatment for patients receiving a lung cancer screening computed tomography (CT) scan.

Conduct Formative Research (Months 1 - 4): Identification of emergent themes and responses to existing booklets.

Adapt and Refine Booklets (Months 5 - 8): Advanced drafts of booklets.

Final Reactions to Draft Booklets (Months 9 - 12): Series of smoking cessation booklets for spiral computed tomography (CT) patients.

Eligibility Criteria:
Inclusion Criteria:

Study 1

* Participants for Study I will be drawn from a list of patients who have received a CT scan at the Moffitt Cancer Center
* Smoked at least one cigarette per week prior to undergoing the CT scan
* Able to speak and read English

Study 2

* Smoked at least one cigarette over the past week
* Able to read English
Longitudinal Pancreatic Cancer Study

To obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of pancreatic cancer.

The study objectives are described below:

1. Obtain serum and plasma specimens longitudinally collected from approximately 140 subjects diagnosed with pancreatic cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 19-9 assays, currently under development, as an aid for monitoring recurrence or progressive disease.
2. To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 19-9 assays, for monitoring the course of disease and therapy in subjects diagnosed with pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, age≥ 18 years
* Histologic/pathologic confirmation of exocrine pancreatic cancer
* Any stage of disease: Newly diagnosed, stable, disease progression
* Any treatment time point: Treatment naïve, currently receiving or completed therapy for pancreatic cancer including active monitoring.
* Individuals with a history of malignant disease other than pancreatic cancer that was resected greater than 5 years ago and are currently in remission are eligible.
* Life expectancy greater than 6 months
* Able to understand and willing to provide informed consent

Exclusion Criteria:

* Males and females, age \<18 years
* No histologic/pathologic confirmation of exocrine pancreatic cancer
* Life expectancy less than 6 months
* Any concurrent malignancy other than basal or squamous cell skin cancers or in-situ cervical cancer.
* Unable to provide informed consent
Acute Satiety and Metabolic Response of Daily Consumption of a Fruit Juice

The "cLabel+ Innovative natural, nutritious and consumer-oriented clean label food" is a research and technological development project centered on responding to the challenges facing the food industry. It is focused on the concept of "clean label", which emerges as one of the major current trends in the sector, given the growing number of consumers who are increasingly aware and eager for information, who are looking for alternative, more transparent and natural food products.

Thus, one of the aims of the cLabel+ project is to research the macronutrients and phenolic compounds present in food matrices and achieve a clean label positioning for the final products developed. This single group assignment clinical trial aims to evaluate the effect of daily consumption of a fruit juice, developed as part of the collaborative project cLabel+, on gut microbiota composition and diversity in healthy adults. It is also intended to study the acute metabolic effect, namely in terms of appetite control, and lipid and glucose metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Men or women
* Adults (age ≥ 18 years)
* Filling informed consent

Exclusion Criteria:

* Obesity (body mass index ≥ 30.0 kg/m2).
* Daily consumption of fruit juices in the month prior to the start of the study.
* Individuals with diagnosed food allergies or intolerances to the components being tested.
* Use of pro/prebiotics or fibre as a dietary supplement or any food/molecule that modifies intestinal transit time 6 weeks before recruitment.
* Use of laxatives 6 weeks before recruitment.
* Recent weight loss or weight gain of more than 10% in the last 3 months.
* Adherence to restrictive weight loss diets or specific dietary pattern (e.g., palaeolithic diet, Atkins, flexitarian, ketogenic, vegan).
* Diagnosis of gastrointestinal pathology, hormonal or thyroid pathology, autoimmune diseases, chronic use of corticosteroids, psychiatric disease, or diabetes mellitus.
* Having taken antibiotics within the 12 weeks prior to beginning the study.
* Excessive consumption of alcoholic beverages (\>14 and \>8 units/week for men and women, respectively).
* Pregnant or breastfeeding.
* Participation in another clinical trial within the past 3 months that the Principal Investigator believes may compromise the results of the trial (e.g., clinical trial with an effect on the composition and diversity of the gut microbiota).
A Study to Evaluate the Effect of Hepatic Impairment on JNJ-56136379

The purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-56136379 in participants with liver cirrhosis and impaired hepatic function when compared with healthy participants with normal hepatic function and no liver cirrhosis.


Eligibility Criteria:
Inclusion criteria:

* For all participants: Body mass index (BMI) between 18.0 and 38 kilogram per meter square (kg/m2), extremes included; Woman of childbearing potential must not be pregnant; Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential; Non-smoker or light smoker as defined per protocol.
* For Healthy Participants with Normal Hepatic Function and No Liver Cirrhosis: Demographically comparable to the study groups with hepatic impairment with respect to sex, age (+/-10 years), and body weight (+/-10 kilogram \[kg\]); Participants must be in good health clinically and biologically as defined per protocol.
* For Participants with Liver Cirrhosis and Moderate or Mild or Severe Hepatic Impairment: Must have a total Child-Pugh score of 5 or 6, inclusive (mild); or 7 to 9, inclusive (moderate); or 10 to 15, inclusive (severe) as determined by the investigator; Must have liver cirrhosis with fibro scan readout greater than (\>) 12.5 Kilopascal (kPa) as cut-off at screening
* Participants with controlled hypertension, with problems directly associated with the primary diagnosis of hepatic impairment and with concurrent stable medical conditions if the condition(s) will not introduce an additional risk factor and will not interfere with the study objectives.
* Concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed.

Exclusion Criteria:

* History of / or current clinically significant medical illness that could interfere with the interpretation of the study results.
* Known allergies, hypersensitivity, or intolerance to JNJ-6379 or its excipients.
* History of drug or alcohol abuse within 1 year before screening or positive test results at screening and Day -1.
* Blood or blood products donated or substantial loss of blood (more than 500 milliliters \[mL\]) within 3 months before the study starts
* Experimental drug received (including investigational vaccines) or experimental medical device used within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study intervention is scheduled.
* Evidence of infection with human immunodeficiency virus (HIV)-1 and HIV-2, hepatitis A, B or C (except if sustained virologic response to hepatitis C virus \[HCV\] treatment).
* Inability to fast for 10 hours.
* Signs of hepatocellular carcinoma or history of biliary obstruction within the past 2 years.
* Lack of good or reasonable venous access.