cyrilzakka/clinical-trials huggingface dataset:
A Clinical Pharmacology Study of MT-3921 in Healthy Adult Males

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics when MT-3921 or a placebo is intravenously given to Japanese healthy adult male subjects


Eligibility Criteria:
Inclusion Criteria: Additional screening criteria check may apply for qualification:

* Japanese healthy adult males
* Subjects aged between 18 and 55 years inclusive at the time of informed consent
* Subjects with a full understanding of the nature of this study who have consented in writing to participate in the study

Exclusion Criteria: Additional screening criteria check may apply for qualification:

* Subjects with or having a history or treatment history of disorders, including cardiac, hepatic, renal, gastrointestinal, respiratory, neuropsychiatric, hematopoietic, or endocrine system disorder, who are judged by the investigator (or subinvestigator) to be unfit for study participation
* Subjects with a history of drug or food allergies, including anaphylaxis or significant allergic reactions
* Subjects with a body mass index (BMI) of less than 18.5 kg/m\^2 or greater than 25 kg/m\^2 at the time of screening or Day -1 or those with a body weight of less than 50 kg or greater than 80 kg
* Subjects who have donated blood or from whom blood samples have been collected in a total amount of 400 mL or more within 12 weeks prior to informed consent, 200 mL or more within 4 weeks prior to informed consent, or 800 mL or more within 1 year prior to informed consent
* Subjects who have donated blood component or platelet apheresis within 2 weeks prior to informed consent
* Subjects with or having a history of drug dependence or alcohol dependence
* Subjects with clinically significant abnormalities on a 12-lead ECG, with a Fridericia-corrected QT (QTcF) interval of ≥450 msec, or with clinically significant abnormalities on an auscultation
* Subjects with a positive result for hepatitis B virus surface (HBs) antigen, serological test for syphilis, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody at screening
* Subjects with a positive polymerase chain reaction (PCR) test for Coronavirus disease 2019 (COVID-19)
* Subjects with a family history of sudden death
* Subjects who answered "yes" to any of the items of suicide ideation or suicide attempts in the Columbia Suicide Rating Scale (C-SSRS) assessment in the screening period
* Subjects who do not agree to practice contraception during the study period
* Subjects who have previously received anti-RGMa antibodies, including this investigational product
* Subjects who have participated in other clinical studies and received other investigational products within 12 weeks before informed consent
* Subjects who have used any drug other than the investigational product in the period within 7 days before the start of investigational product administration or 5 times the half-life of the drug, whichever is longer
Monitoring Efficacy of Radiotherapy in Lung Cancer and Esophageal Cancer

Lung cancer, one of the malignant tumors which poses a threat to human's health, has increased morbidity and mortality recently. Radiotherapy, as one of the common treatments, has important value in clinical application. Esophageal cancer, one of the most common digestive system cancers, has poor prognosis and high mortality. Esophageal cancer has high aggressive and many patients can't get surgical treatment because of the tumor metastasis at the time of diagnosis.Currently, chemoradiotherapy has become one of the standard treatment regimens for patients with unresectable esophageal cancer in National Comprehensive Cancer Network(NCCN). So radiotherapy is one of the most important treatments in esophageal cancer.

Currently, the efficacy evaluation method of radiotherapy is by imaging examination after several courses of treatment. However, new reports suggest that circulating tumor DNA(ctDNA) has the potential to be an indicator of therapeutic effectiveness and recurrence risk.

Circulating free DNA (cfDNA) can be found dissolved in plasma and serum, at variable amounts. In the case of cancer patients, ctDNA is a fraction of the cfDNA derived from tumor. Currently, the ctDNA is widely used in "liquid biopsy" for not only does it carry the same somatic alterations as the tumor itself but also its percentage is correlated with tumor burden.

This study will investigate the clinical value of efficacy evaluation and prognosis of ctDNA detecting technique in patients with radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histopathological proved lung cancer or esophageal cancer.
* Candidate for radiotherapy.
* No history of prior anti-tumor treatment.
* Eastern Cooperative Oncology Group (ECOG) score 0,1.
* Being able to receive computed tomography (CT) and magnetic resonance imaging (MRI).
* Blood sample is available for dynamic monitoring.
* Written informed consent provided.
* Good compliance in the follow-up.

Exclusion Criteria:

* Had received radiotherapy, chemotherapy, biotherapy or other treatment that is related to lung cancer or esophageal cancer.
* The patients have the sign of any serious or uncontrolled systematic diseases that may have significant impact on the balance between risk and benefit, such as hypertension, infection of hepatitis B, hepatitis C or human immunodeficiency virus(HIV).
* With history of alcohol or drug abuse.
Pupillary Dilation Reflex Assessment for Intraoperative Analgesic Titration.

In this double blinded randomized controlled study, the pupillary dilation reflex is used for as a nociceptive indicator for opioid administration during elective surgery under general anesthesia.

An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response of a nociceptive stimulus. This autonomic reflex, parasympathetic mediated in sedated patients, can be generated by various pain stimuli (built in standardized protocol, surgical incision, ...) The PDR is a robust reflex, even in patients under general anesthesia, and provides a potential evaluation of the autonomous circuit within the nociceptive evaluation based on pupil dilation upon A-delta and C fibers in both electrical or mechanic stimulation. This double blind randomized controlled trial involving American Society of Anesthesiologists (ASA) classification I-III patients undergoing elective surgery under general anesthesia are recruited. Enrolled patients are randomized in four groups: (1) remifentanil administration depending on PDR results, (2) remifentanil administration depending on decision attending anesthesiologist, (3) sufentanil administration depending on PDR results, (4) sufentanil administration depending on decision attending anesthesiologist.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 jaar
* Elective abdominal or gynaecological operation
* ASA (American Society of Anesthesiologists classification): I - II - III

Exclusion Criteria:

* History of invasive ophthalmological surgery
* Known bilateral eye disease
* Known optical of oculomotor nerve deficit
* Active psychiatrical disease
* Proven active pheochromocytoma
* Opioid usage \> 7 days preoperative
* Ongoing oncological treatment with chemotherapeutic agents
* Usage of A-1 adrenergic of beta-blocking agents
* Preoperative usage of benzodiazepines
* Topical atropine or phenylephrine (eye droplets)
* Planned perioperative usage of dopamine antagonists
Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer

The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b clinical study.


Eligibility Criteria:
For complete inclusion and exclusion, please refer to the investigator.

Inclusion Criteria:

* Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
* Subjects with advanced cancer in whom the gemcitabine and cisplatin chemotherapy regimen is clinically indicated
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematological function
* Adequate renal function
* Adequate hepatic function
* Life expectancy of greater than or equal to 3 months as documented by the investigator

Exclusion Criteria:

* More than 1 prior chemotherapy regimen
* History of venous thrombosis
* Myocardial infarction, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, or unstable angina within 1 year before study enrollment
* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on screening chest computed tomograph (CT) scan
* Average systolic blood pressure of greater than 145 mm Hg or average diastolic blood pressure of greater than 85 mm Hg
* Radiotherapy within 28 days of study enrollment or within 14 days of study enrollment for peripheral lesions
* Prior AMG 706, panitumumab, or another anti-EGFr monoclonal antibody (mAb) (e.g., cetuximab \[Erbitux®\] or EMD 72000)
* Systemic chemotherapy within 28 days before study enrollment
* Major surgery within 28 days or minor surgery within 14 days of study enrollment
* Central nervous system metastases (Exception: subjects with treated asymptomatic central nervous system metastases, those who have been clinically stable in the judgment of the investigator and off steroids for at least 30 days before the study enrollment are eligible)
Cross-sectional Survey on Patients With Urinary Tract Infections in Puy-de-Dôme : Epidemiology of Recurrent Urinary Tract Infections and Risk Factors

Urinary tract infections (UTI) are an important part of infectious diseases. For some patients, those infections are recurrent and have many consequences such as altered quality of life, recurrent symptoms, antibiotics overuse... The primary purpose of this study is to estimate the proportion of patients in Puy-de-Dôme with recurrent urinary tract infections among patients with at least one UTI during 2019. The secondary purposes are : characteristics of patients with recurrent UTI, by sex ; determine predictive factors of recurrent UTI, by sex ; describe bacterial ecology of recurrent UTI and the proportion of multi-resistant bacteria.


Eligibility Criteria:
Inclusion Criteria:

* patient from 18 years old
* affiliated to the french healthcare system
* with at least one urinary tract infection during year 2019
* has accepted email contact with CPAM 63 (Caisse Primaire d'Assurance Maladie du Puy-de-Dôme)

Exclusion Criteria:

* pregnancy during year 2019
* none urinary tract infection reported in 2019
Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus

This randomized phase III trial is studying laparoscopic surgery to see how well it works compared to standard surgery in treating patients with endometrial cancer or cancer of the uterus. Laparoscopic surgery is a less invasive type of surgery for cancer of the uterus and may have fewer side effects and improve recovery. It is not known whether laparoscopic surgery is more effective than standard surgery in treating endometrial cancer.

OBJECTIVES:

I. Compare the incidence of surgical complications, peri-operative morbidity, and mortality in patients with stage I or IIa, grade I-III endometrial cancer or uterine cancer undergoing surgical staging through laparoscopic assisted vaginal hysterectomy vs total abdominal hysterectomy.

II. Compare the length of hospital stay after surgery in patients receiving these treatments.

III. Compare the quality of life of patients receiving these treatments. IV. Compare the incidence and location of disease recurrence in patients receiving these treatments.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo vaginal hysterectomy and bilateral salpingo-oophorectomy (BSO) via laparoscopy.

ARM II: Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.

Patients in both arms also undergo pelvic and para-aortic lymph node sampling. Quality of life is assessed at baseline, at 1, 3, and 6 weeks, and then at 6 months.

Patients are followed at 6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage I or IIA, grade I-III endometrial adenocarcinoma or uterine sarcoma
* Must be considered a candidate for surgery
* No contraindication to laparoscopy
* No clinical or chest x-ray evidence of metastasis beyond the uterine corpus or macroscopic involvement of the endocervix
* Performance status - GOG 0-3
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
* Creatinine no greater than 2.0 mg/dL
* Prior malignancy allowed if no current evidence of disease
* Not pregnant
* No prior pelvic or abdominal radiotherapy
* See Disease Characteristics
* No prior retroperitoneal surgery
An Analysis of Burnout Among Surgery Residents at a Tertiary Care Hospital in Pakistan: A Prospective Cohort Study

To determine the scores of exhaustion, depersonalization and personal achievement according to Maslach Burnout Inventory (MBI) in surgical residents.

A prospective cohort study was conducted at Pakistan Institute of Medical Sciences Islamabad with a 6-month duration from June 1, 2023 to November 30, 2023 after approval from the Institutional review board, 95 surgical residents working in Departments of Surgery \& Allied of age less than 35 years (any gender) with duty of at least 60 hours per week were enrolled in study by using non-probability convenience sampling technique. Residents were informed about the study procedure and consent for inclusion was taken from them. Data analysis was done through SPSS v.26.

Eligibility Criteria:
Inclusion Criteria:

* Residents working in departments of surgery and allied
* Both genders
* Less than 35 years old
* Performing duty of at least 60 hours per week

Exclusion Criteria:

* Those who did not wish to participate
Effectiveness of Pulpotomy in Carious First Permanent Molar

Pediatric dentists frequently encounter deeply carious young permanent first molars (PFM) with Molar Incisor Hypomineralisation (MIH). Pulpal status of affected PFM was found to be different from that of unaffected PFMs which consequently might influence the pulpal response after vital pulp therapy.

The aim of this study is to evaluate the clinical and radiographic effectiveness of partial removal of pulp in deeply carious symptomatic PFM affected with MIH over 24 months.

Pediatric dentists frequently encounter deeply carious young permanent first molars (PFM) with Molar Incisor Hypomineralisation (MIH). Pulpal status of affected PFM was found to be different from that of unaffected PFMs which consequently might influence the pulpal response after vital pulp therapy. The aim of this study is to evaluate the clinical and radiographic effectiveness of partial removal of pulp in deeply carious symptomatic PFM affected with MIH over 24 months. In this prospective randomized controlled clinical trial, a randomized assigned sample of 96 children each with a deeply carious young PFM, Group I (n=48) diagnosed with MIH and irreversible pulpitis and Group II (n=48) diagnosed with irreversible pulpitis but not affected with MIH. Group I will be randomly equally allocated into Group II A (n=24): partial pulpotomy (PP) and Group I B (n=24): full pulpotomy (FP). Group II will also be randomly equally allocated into Group II A (n=24): PP and Group II B (n=24): FP. If pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. The pulpotomy agent to be used will be mineral trioxide aggregate (MTA) and teeth will be restored using a resin modified glass ionomer restoration (RMGIC). Teeth will be followed up clinically and radiographically using periapical x-rays for 24 months. Cone beam computed tomographic scans will be taken initially and at 24 months. Pain levels will be scored preoperatively before local anesthetic administration and postoperatively every 24 hours for 7 days using visual analogue scale. All data will be statistically analyzed and discussed considering the results obtained.

Eligibility Criteria:
Inclusion Criteria:

* 7-13-year-old children.
* At least one deeply decayed first permanent molar, checked through periapical x-ray)
* Noncontributory medical history.
* The tooth should be showing irreversible pulpitis signs and symptoms.
* The tooth is restorable and probing pocket depth and mobility within normal limits.
* No signs of pulpal necrosis including sinus tract or swelling.

Exclusion Criteria:

* Non-restorable teeth.
* Negative response to cold testing.
* Presence of sinus tract or swelling.
* No pulp exposure after caries excavation.
* Bleeding could not be controlled after partial pulpotomy in 6 minutes.
* Insufficient bleeding after pulp exposure; the pulp is judged necrotic or partially necrotic.
* History of analgesic intake 3 days prior to the day of commencement of procedure.
Effect of Moxibustion Intervention on Insomnia Patients

Type of study:clinical trial Purpose of research:To explore the efficacy and safety of moxibustion combined with Traditional Chinese and Western medicine in treating insomnia.

Describe participant population/health conditions:120 insomnia patients

Type of study:clinical trial Purpose of research:To explore the efficacy and safety of moxibustion combined with Traditional Chinese and Western medicine in treating insomnia.

Describe participant population/health conditions:120 insomnia patients The participants were enrolled according to the principle of randomization and single blindness, and the analysis was adjusted every quarter according to the research schedule. The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with only western medicine.

Clinical evaluation of the main efficacy indicators: The score of PSQI scale was assessed. The reduction rate of PSQI scale was ≥ 25% as effective, and the difference between the two groups was compared as the basis for evaluating the main efficacy indicators. The efficacy of insomnia symptoms was evaluated by the difference of PSQI score reduction rate between groups before and after intervention.

Secondary clinical outcome measures: Quality of Life Scale (SQLS), SF-36 scale, Clinical Gross Impression Scale (CGI), adverse reaction（TESS） .

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of ICD-10 insomnia;
2. In line with the relevant diagnostic criteria of TCM syndrome differentiation of heart-spleen and deficiency type insomnia (TCM syndrome diagnosis criteria according to the 1993 Ministry of Health "Guidelines for Clinical Research on the treatment of Insomnia with new Chinese Medicine" standards: heart-spleen and deficiency: palpitation, amnesia, dizziness, poor and tired, pale face, easy to sweat, tongue, thin coat, thin pulse);
3. Pittsburgh Sleep Quality Index (PSQI) score \> 7 at baseline;
4. The treatment plan used in this study is tolerable, cooperative and compliant;
5. Regardless of gender, age 18-65 years old;
6. Understand the procedure and content of the test, and voluntarily sign the informed consent;

Exclusion Criteria:

1. Participating in other clinical studies;
2. Exclude patients with serious physical diseases or diseases that may affect the evaluation of the test;
3. there is a clear risk of suicide or danger to oneself or others;
4. Exclude pregnant or lactating women, or those planning pregnancy;
5. Persons with alcohol and drug dependence within 1 year prior to screening.
Sexaffectivity in Autistic Spectrum Disorder

The WHO defines sexual health as a state of physical, emotional, mental and social well-being, related to sexuality, not only the absence of illness, dysfunction or disability. To acquire and maintain adequate sexual health, the sexual rights of all people must be respected, protected and fully exercised.

People with Autism Spectrum Disorder (ASD) present difficulties in the development of social interaction skills, among other problems that directly affect their sexual health. The consolidated prejudices and social myths related to the sexual affectivity of people with ASD, and in general to people with intellectual diversity, have meant that they do not pay any attention to the sexual health of this group in the assessment of their needs.

Main objectives: to understand the experience lived by young people with ASD and their caregivers in relation to the affective needs during adolescence and to know the cognitive and behavioral expression of the affective dimension of adolescents with ASD.

Mixed simultaneous design: qualitative based on the phenomenological paradigm, in order to establish the perceived needs of young adults with ASD, their families and the professionals who attend them, with the realization of focus groups and in-depth interviews. The second quantitative part will be developed in adolescents (12-18 years) and their families, evaluating the habitual behaviors and difficulties of Interaction in the affective expression, by means of questionnaires and self-administered scales. It will be necessary to sign the Informed Consent by all the participants, with the specific acceptance of the project by the CEIC of the investigator's center.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents with ASD. 12-18 years old

Exclusion Criteria:

* Non defined
Human Leucocyte Antigen G and Chronic Heart Failure

The Human leukocyte antigen G (HLA-G) is a non-classical, major histocompatibility complex class I (MHC-I) protein that modulates the immune response, inhibiting it in most cases. Physiologically expressed in the cells of some tissues, it increases in inflammatory reactions. Inflammation appears to play an important role in the development of chronic heart failure. This study aims to evaluate the levels of soluble HLA-G in patients with heart failure and to investigate the relationships between HLA-G and other clinical-functional parameters of the disease. Investigators hypothesize that the plasma levels of HLA-G could correlate with the clinical status of heart failure and could provide indications on patient's prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with recent diagnosis of chronic heart failure as defined by the guidelines of the European Society of Cardiology (ESC) and with cardiac ejection fraction \<40.
* Clinical stability in the previous month prior to recruitment.
* Absence of coexisting autoimmune diseases.

Exclusion Criteria:

* Subjects with over one year chronic heart failure diagnosis and in clinical stability for less than 1 month.
* Presence of autoimmune diseases.