cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

The purpose of this study is to determine what the study drug does to the body, what the body does to the study drug, and if the study drug is safe and well tolerated when given to adult healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects.
* Healthy non-child bearing female subjects.
* 18 to 35 years of age.

Exclusion Criteria:

* Heart disease.
* Clotting disorders.
* Use of nicotine products.
* Diabetes.
Effect of a Traditional Chinese Medicine Formulation on COVID-19 Infection

Traditional Chinese medicine (TCM) has been handed down for thousands of years. It has a long history in the treatment of virus infection and has a good effect on the upper respiratory tract infection.

In recent years, the project applicant has been conducting research on the anti infection and anti inflammation treatment of traditional Chinese medicine, and has carried out a lot of clinical practice exploration in non-specific inflammation.

The purpose of this research is to study the therapeutic effect of a traditional Chinese medicine prescription on COVID-19 infection.


Eligibility Criteria:
Inclusion Criteria:

* In the past two to three days, COVID-19 test was positive, accompanied by more than one clinical symptom.
* 18 ≤ age ≤ 65, regardless of gender;
* Patients have good follow-up compliance.

Exclusion Criteria:

* Human immunodeficiency virus - 1 infection and malignant tumors; Active cardiovascular, kidney, lung, liver, blood, digestive, neurological or psychiatric diseases; Recent acute respiratory symptoms (within 4 weeks) .
* Any drug that may interfere with the evaluation (for example, other herbal products such as Lianhua Qingwen, immunosuppressants, anticoagulants), or a history of allergy or other adverse reactions to traditional Chinese medicine products.
* Pregnant or lactating women.
* Allergic constitution and allergy to multiple drugs.
* According to the judgment of the investigator, the subject suffers from any disease that may endanger his safety or affect his compliance with the protocol, or other conditions that are not suitable for the study.
Study of Cisplatin in Cervical Cancer Stage IVB

This is a single arm, open-label study in women from China who have Advanced (stage IVB) Recurrent or Persistent cervical cancer to ⑴assess the response rate (i.e., CR + PR) of Cisplatin combined with Topotecan in treatment of advanced (stage IVB) recurrent or persistent Cervical cancer; ⑵assess the toxicities of CT regimen in treatment of cervical cancer. Prior to treatment, written informed consent should be obtained from all patients. Eligible patients will be assigned to CT regimen. The CT regimen is topotecan 0.75 mg/m2 IV during 30minutes days 1, 2, and 3; followed by cisplatin 50 mg/m2 IV on day1, repeated every 21 days. The study will consist of two phases: the safety run-in phase and study phase.


Eligibility Criteria:
Inclusion Criteria:

* women with advanced recurrent or persistent carcinoma of the uterine cervical who were unsuitable candidates for curative treatment with surgery and/or radiotherapy.
* Histologic types included squamous, adenosquamous, and adenocarcinoma of the cervia.
* Patients must be at least 18 years old.
* Measurable and/or evaluable disease parameters will be documented and recorded using clinical evaluation (and using CT for pathologic nodes when present).
* Life expectation greater than 3 months.
* Patients must have adequate organ function.
* Patients without history of sensitivity to camptothecin or platinum.
* Patients who are non-child-bearing potential, or consistent and correct use of methods of birth control from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of observational medication.
* performance status 0 to 2; to have recovered from the effects of recent surgery, chemoradiotherapy, or radiotherapy; and to be free of clinically significant infection.
* Written informed consent

Exclusion Criteria:

* Patients with uncontrolled infections.
* Patients with concurrent severe medical problems unrelated to the malignancy which would expose the patient to extreme risk.
* Patients who received another investigational drug within 30 days prior to study entry.
* Patients who are receiving concurrent other chemotherapy, hormonal, immunotherapy or radiotherapy. Radiotherapy for palliation of related bone metastases is permitted.
* Patients with a history of allergic reactions to compounds chemically related to topotecan or platinum.
* Patients who are pregnant or lactating
* Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin.
The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study in Type 1 Diabetes

The study is designed to evaluate two different dietitian-led self-management approaches in carbohydrate counting compared to routine dietary care (control) on glycaemic control in adult patients with type 1 diabetes:

1. The basic carbohydrate counting concept aims at improving carbohydrate counting accuracy and day-to-day consistency of carbohydrate intake (the BCC intervention)
2. The advanced carbohydrate counting concept aims at improving prandial insulin dose accuracy using an automated bolus calculator (the ABC-ACC intervention)

The main hypothesis is that structured training and education in either the BCC concept or the ABC-ACC concept will reduce HbA1c or the average glucose variability more than routine dietary education.

The current study is a randomized controlled trial with a parallel-group design. A total of 231 patients will be enrolled in the trial. Participants will be randomized to one of three arms: 1) Basic carbohydrate counting (BCC), 2) Advanced carbohydrate counting with an automated bolus calculator (ABC-ACC), or 3) Standard dietary care.

The primary objective is to evaluate the six months effects of education in the BCC concept and the ABC-ACC concept compared to standard dietary care on glycaemic control as assessed by HbA1c or MAGE (mean amplitude of glycaemic excursions).

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Diabetes duration; \>12 months
* HbA1c of 53-97 mmol/mol
* Multiple daily insulin injection therapy
* Provided voluntary written informed consent

Exclusion Criteria:

* Practicing carbohydrate counting, as judged by the investigator
* Participated in a BCC group program within the last two years
* Use of insulin pump, or plans of having an insulin pump within the study period
* Fixed dose of rapid acting insulin therapy for meals
* Split-mixed insulin therapy
* Use of open CGM
* Use of Freestyle Libre
* Use of an automated bolus calculator
* Gastroparesis
* Pregnancy or breastfeeding, or plans of pregnancy within the study period
* Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day), as judged by the investigator
* Uncontrolled medical issues, as judged by the investigator or a medical expert
* Concomitant participation in other clinical studies
* Unable to understand the informed consent and the study procedures
Disease Perception and Oral Health Impact Profile (OHIP) Before and After Non-surgical Periodontal Treatment

The presence of periodontal diseases in patients has been associated to a worsened quality of life overall. Many different indices have been proposed over time in order to evaluate patient's centred outcomes. In particular, the most thorough questionnaire proposed so far is the Oral Health Impact Profile 49 (OHIP-49), which is composed of 49 questions. Despite its validity being unquestionable, OHIP-49 was found to be too time-consuming for the clinical scenario and, therefore, its shortened 14-question version has been proposed. A more in-depth knowledge of how these parameters change before and after periodontal treatment could enable clinicians to tailor the treatment plan according to the patients' needs.


Eligibility Criteria:
Inclusion Criteria:

* patients being at least 18 years old
* Patients with a diagnosis of Periodontitis

Exclusion Criteria:

* diagnosis Gingivitis
* diagnosis of periodontal health
* inability or unwillingness to give informed consent
DiaPort Closed-Loop Artificial Pancreas

The primary purpose of this pilot study is to test an artificial pancreas system which uses the intra-peritoneal (IP) route for insulin delivery in type 1 diabetic patients.

During this study, the investigators would like to evaluate the intra-peritoneal insulin delivery as a potential breakthrough method for delivering insulin within the artificial pancreas system.

The intent is to exploit the rapid action achieved by IP insulin to compensate for meals and for management of the basal insulin needs. Patients will come for two closed-loop admissions of 24 hours. The first closed-loop will be performed using subcutaneous route, whereas the second one will be performed using the intra-peritoneale route.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be aged between 18 (inclusive) and 65 years old
* Patient must have been clinically diagnosed with Type 1 diabetes mellitus for at least one year
* Patient must have been identified as presenting an indication for the DiaPort® system, i.e. showing poor glucose control under Sc insulin delivery as shown by a sustained HbA1C level \> 8% and/or high blood glucose variability including recurrent hypoglycemic events. Patient will be eligible for the study because he/she will have a DiaPort implanted.
* Patient must demonstrate proper mental status and cognition for the study
* Patient must be affiliated or beneficiary of a social medical insurance
* Patient has signed informed consent form prior to study entry

Exclusion Criteria:

* Unwilling to perform repeated glucose checks, consume standardized meals, and/or take insulin as instructed
* Evidence of cardiovascular event during the previous 6 months, non stabilized retinopathy, or clinically significant screening laboratory abnormalities
* Pregnancy, breast feeding, or intention of becoming pregnant
* Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study admissions.
* Patient is actively enrolled in another clinical trial or was part of study within 30 days or whose annual study income is over 4 500€
* Persons deprived of freedom, adults protected by law or vulnerable persons
Confirming And Notifying Death

Most physicians are confronted with the death of patients during their practice, often as early as residency. It is their legal responsibility to certify a patient's death, as well as often to notify their loved ones.

Yet, these duties currently receive little or no specific training during the various cycles of medical education.

This task is not easy, however, and young professionals experience it with difficulty. Literature data show that residents are confronted with death late in their medical education and that they are insufficiently prepared when they have to perform their first death certificate. Indeed, residents report significantly correlated practical and emotional difficulties. These difficulties are notably linked to a feeling of lack of preparation through theoretical courses, a lack of familiarity with administrative procedures, and insufficient mastery of communicating with families. The highlighting of these difficulties and the desire for appropriate and respectful care for the deceased and their families, for whom the moment of announcement influences the experience of grief, call for an improvement in teaching on these topics. It is in this sense that the project was born to explore whether the creation of training, before their independent exposure to death and its announcement, i.e. at the end of the second cycle, was relevant. A prerequisite for this type of training project is indeed to question the acceptability of such an approach by students.


Eligibility Criteria:
Inclusion Criteria:

* DFASM3 student,
* At the Faculty of Medicine of Strasbourg, France, for the 2023-2024 academic year,
* Having taken the national ECOS (thus becoming an intern at the start of the following academic year in November 2024),
* Aged 18 years or older,
* Not opposed to participating in the study.
* Not having completed an internship in specialized palliative care facilities

Exclusion Criteria:

* Refused to participate in the study.
* Not having taken the national ECOS.
Relationship of de Ankle ROM With Balance and Falls in Older Adults

The ankle is an important joint to maintain a good balance within the population of the older adult. As people get older, problems appear in this joint. Many of these problems affect the correct joint range of the ankle. There is evidence to suggest that a lower range of motion in the ankle can negatively affect balance and, consequently, increase the risk of falls in the elderly. It would be interesting to assess if this relationship is true. The aim of the study will be to study if the state of the joint range of the ankle is related in some way to balance and falls in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* Be 60 years old or older

Exclusion Criteria:

* Do not sign the informed consent
* Lower limb injury in the previous three months
* Presenting severe pathology that affects balance or mobility
Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes

The aim of the study is to investigate the effect of preoperative patient education on the level of properative anxiety and postoperative psychosocial outcomes. Participants will be assigned to one of the 3 study groups: on-line education, contact education and control (no preoperative education). The investigators will evaluate preoperative anxiety level at different time points (baseline at 2 weeks before the surgery, at the evening before the surgery and postoperatively) and investigate dynamics of anxiety in the perioperative period. Additional qualitative interview by psychologists will be performed to evaluate the potential causes of increased/decreased preoperative anxiety.

Impact on postoperative complications, well-being of the participant, quality of recovery and satisfaction with medical care will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* agreement to participate in the study
* elective cholecystectomy or colon surgery

Exclusion Criteria:

* refusal to participate in the study
* do not speak Lithuanian
* do not pass the PHQ-2 depression screening test
Effect of Nonsurgical Periodontal Therapy on Salivary Biomarkers Related to Bone Turnover in Smoker and Nonsmoker Periodontitis Patients

1. To assess the alteration in the level of salivary osteopontin (OPN), osteonectin(ON) and histatin-1 following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals(one month and three months) .
2. To evaluate the response of clinical periodontal parameters ( plaque index ,bleeding on probing ,probing pocket depth ,clinical attachment loss)following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals (one month and three months)

the study include nonsurgical periodontal therapy for smoker and non smoker patients with unstable periodontitis and evaluate the clinical periodontal parameters ( plaque index, bleeding on probing , probing pocket depth ,clinical attachment loss) and assess the alteration in the level of salivary osteopontin (OPN), osteonectin(ON) and histatin-1 following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals(one month and three months)

Eligibility Criteria:
Inclusion Criteria:

* participants will be systemically healthy without history of any systemic diseases.
* hadn't underwent periodontal treatment during the previous 6 months and not taken medication during the previous 3 months.
* present with at least 20 teeth, those who only diagnosed with 4-6 mm probing pocket depth, generalized ,unstable periodontitis who had bone loss \> 30% , probing probing pocket depth at ≥4mm . Periodontitis cases were defined if clinical attachment loss was detected at ≥2 non- adjacent teeth or when buccal (facial) showed clinical attachment loss ≥3mm associated with probing pocket depth \>3mm at ≥ 2 teeth .
* The patients in the smokers group will be current smokers ( cigarette smokers) with smoking habit for over 3 years

Exclusion Criteria:

* Subjects have any intraoral plaque retentive factors such as those wearing partial denture, crown and bridges, and orthodontic appliances ,furcation involved teeth, overhang filling, tooth anomaly.
* receiving antibiotic therapy during the previous 3 months.
* those with systemic diseases such as diabetes mellitus, cardiovascular or renal diseases, etc...., pregnant or lactating women, not willing to participate or continue to conduct the study.
Abdominal Wall Closure With Triclosan-coated Suture

After open colorectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of the investigators randomized, prospective, multicentric, internet-based study is to compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are involved in this study. Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS versus PDS-Plus). Triclosan is an antiseptic material which the investigators hope will provide better local infection control at the site with reducing the risk of bacterial colonisation.

After open colorectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of our randomized, prospective, multicentric, internet-based study is to compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. Two arms are separated by computer randomization at abdominal wall closure: application of triclosan-coated and non-coated PDS suture (PDS versus PDS-Plus). Triclosan is an antiseptic material which we hope provides better local infection control at the site with reducing the risk of bacterial colonisation.

attached website: www.itplan.hu/sebstudy/ Randomizing patients: 1. logging in (completing the ID panel) 2. on-line randomization 3. patient appears on list 4. operation (recording details) 5. recording - post-operation events

* complications
* control examination

Eligibility Criteria:
Inclusion Criteria:

* Elective (subjected to bowel preparation) operations
* Benign or malignant colon or rectal disease
* Age: 18-80
* Bowel opening is made during operation

Exclusion Criteria:

1. Cannot be randomized:

   * Systemic diseases influencing local surgical site healing
   * Insulin-dependent diabetes mellitus
   * Child B-C liver cirrhosis
   * Kidney disease requiring dialysis
   * Immune-suppression treatment
   * IBD
   * Acute surgery or unprepared bowel
   * After being informed patient does not sign the statement of consent
2. To be excluded later:

   * Surgically incurable tumour
   * Septic state or complication occurred in the post-operational stage
   * Patient withdraws the signed consent before the examination is closed
3. Undesirable complication:

   * Sterile surgical site separation
   * Suture break during the post-operational stage
Treatment Protocol of Plozasiran in Adults With FCS

This is a treatment program for the use of plozasiran in adults with Familial Chylomicronemia Syndrome (FCS). The program will enroll eligible patients ≥18 years of age, with fasting triglycerides ≥880 mg/dL (≥10 mmol/L) that is not adequately controlled with standard lipid-lowering therapy, and with a diagnosis of FCS. Patients will receive 25 mg of plozasiran by subcutaneous (sc) injection on Day 1 and every three months for a total of 5 injections. The duration of the program is 15 months.


Eligibility Criteria:
Inclusion Criteria:

* Fasting triglycerides (TG) ≥ 880mg/dL that is not sufficiently controlled on standard lipid-lowering therapy
* Established diagnosis of FCS based on documented history of fasting TG levels in excess of 1000 mg/dL on repeated testing (for at least 3 prior occasions), and at least one of the following: a supportive genetic test, documented history of recurrent episodes of acute pancreatitis not caused by alcohol or cholelithiasis, documented history of recurrent hospitalizations for severe abdominal pain without other explainable cause, documented history of childhood pancreatitis, family history of hypertriglyceridemia-induced pancreatitis
* Willing to follow dietary counseling based on local standard of care, consistent with an intake of ≤ 20 g of fat per day
* If on medications for management of type 2 diabetes the dosing regimen must be stable.
* Participants of childbearing potential must agree to use a highly effective form of contraception in addition to a male condom during the program and for at least 90 days after the last dose of plozasiran

Exclusion Criteria:

* Diabetes mellitus with any of the following at Day 1: newly diagnosed within the past 24 weeks, HbA1c ≥9.0% within the past 4 weeks, meaningful medical events relating to poor glycemic control, changes in basal insulin regimen of more than =/- 10 units within 12 weeks if insulin-dependent
* History of acute coronary syndrome events
* New York Heart Association Class III or IV heart failure or last known ejection fraction of \<30%
* Clinical evidence of primary hypothyroidism, primary subclinical hypothyroidism, or secondary hypothyroidism
* History of stroke, transient ischemic attack, or peripheral artery disease within 24 weeks of first dose
* History of bleeding diathesis or coagulopathy
* Current diagnosis of nephrotic syndrome
* Eligible to receive any commercially available FDA-approved therapeutic for treatment of FCS unless proven to be ineffective or judged inappropriate by the treating physician

Note: Additional inclusion/exclusion criteria may apply per protocol
A Study of HM10760A (Long-acting Erythropoietin) in Healthy Adult Caucasian and Japanese Subjects

Study design:

* Phase I, first-in-human, randomized, double-blind, placebo-controlled, sequential dose escalation study of intravenously administered HM10760A in healthy adult Caucasian and Japanese subjects. Up to 5 dose level cohorts are planned. In each dose level cohort, subjects will be randomized to receive a single dose of HM10760A or placebo.

Primary Objective:

* To evaluate safety profile of single intravenous (IV) dose levels of HM10760A in healthy adult Caucasian and Japanese subjects.

Secondary Objectives:

* To evaluate the dose response relationship of a single IV dose of HM10760A on pharmacodynamic parameters
* To assess the immunogenicity of a single IV dose of HM10760A.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian and Japanese male and/or female volunteers
* Age 18 to 55 years
* Hemoglobin of \>12 g/dL and \<16 g/dL for male subjects, \>10 g/dL and \<14 g/dL for female Caucasian subjects

Exclusion Criteria:

* Prior exposure to EPO, darbepoetin, other EPO support proteins
* hypersensitivity to EPO, darbepoetin, E.coli derived proteins
* Hemoglobinopathy
* SBP \> 140 mmHg or \< 90 mmHg or DBP \> 95 mmHg
* Chronic, uncontrolled, or symptomatic inflammatory disease
* Malignancy(except non-melanoma skin cancer)