cyrilzakka/clinical-trials huggingface dataset:
A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM

The goal of this study is to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1(programmed death receptor 1) inhibitor for colorectal cancer liver metastasis and furthermore to clarify its application value by comparing preoperative and postoperative immune indicators.

This is a single-center, single-arm, prospective study to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis. The study includes 20 patients with colorectal cancer liver metastasis that has failed first-line therapy and is unresectable. All patients will receive multi-mode ablation to achieve complete remission of liver lesions followed by systemic therapy including PD-1 inhibitor.

This study will provide preliminary data on the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis, which could lead to larger randomized trials.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years, gender not specified;
2. Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection;
3. In the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction;
4. Failure of first-line treatment, with disease progression or new liver metastases;
5. No more than 5 liver lesions, with single lesion diameter ≤ 3cm;
6. For those who have received previous chemotherapy, radiotherapy or local liver treatment, the interval from the last systemic treatment or local liver treatment should be at least 1 month;
7. Child-Pugh A or B; bilirubin ≤ 3.0 mg/dL, creatinine ≤ 2.5 mg/dL, white blood cell count ≥ 2.0 ×10\^9/L, platelets ≥ 100 ×10\^9/L;
8. ECOG PS ≤ 2;
9. Willing to accept subsequent treatment regimens that include anti-PD-1 monoclonal antibody therapy.

Exclusion Criteria:

1. Liver function Child-Pugh class C;
2. Expected survival \< 3 months;
3. Major organ insufficiency or failure;
4. Active infection;
5. Irreversible coagulation disorders;
6. Refractory massive ascites, pleural effusion or cachexia;
7. Unable to cooperate with treatment;
8. Any other factors deemed inappropriate for inclusion or that may affect the subject's participation in the study, as determined by the investigator.
Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple Disabilities

The main purpose of this study is the evaluation of the efficacy of zoledronic acid on bone density in children with osteoporosis caused by multiple disabilities.

Secondary purposes are:

1. Description of child population with osteoporosis in the context of motor impairment in Lorraine region
2. Description of osteoporosis stage (level of bone mineralization and clinical consequences) in children with multiple disabilities
3. Description of current osteoporosis preventive care
4. Description of risk factors associated to bone status (drugs)
5. Evaluation of zoledronic acid treatment on fracture numbers
6. Evaluation of zoledronic acid on phosphocalcic profile
7. Description of side effects of zoledronic acid in this indication
8. Description of treatment effects in the sub-population of children with Rett syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Non refusal of parents of participation of their child to the study
* Patients followed for multiple disabilities
* Osteoporosis: lumbar osteodensitometry z-score \<-2.5 SD associated or not to pathologic fracture

Exclusion Criteria:

* Bone pathology due to other genetic reasons (rickets, osteogenesis imperfecta)
* Absence of multiple disabilities
Potential Predictive Biological Markers of Major Depression Response to Citalopram Therapy in Anorexia Nervosa.

In patients suffering from anorexia nervosa associated with severe major depression, serotonin reuptake inhibitor drugs have shown little efficacy in significantly reducing depressive symptoms. A possible explanation for this poor efficacy could be that people with anorexia nervosa have a deficiency in amino acids such as tryptophan, which is necessary for the production of the neurotransmitter serotonin. Therefore, tryptophan supplementation has been suggested as a means of increasing the pharmacological response to serotonin reuptake inhibitor drugs in patients with anorexia nervosa. Furthermore, malnutrition present in patients suffering from anorexia nervosa is in some cases associated with problems of intestinal absorption of nutrients, with possible implications on the pharmacokinetics of the drugs administered, including selective serotonin reuptake inhibitors (SSRIs).

The present observational study aims to evaluate the correlations between the clinical response to Citalopram therapy (in different o.s. and i.v. formulations) and some nutritional, neurotransmitter and inflammatory biomarkers, in order to identify potential predictive markers of response to therapy for severe major depression in patients with anorexia nervosa.

The following parameters will be evaluated in patients enrolled in all 3 observation times described above:

* Plasma concentration of Citalopram
* Serum concentration of Serotonin
* Plasma concentration of dopamine
* Serum concentration of Tryptophan
* Serum concentration of BDNF
* Hamilton scale 17 items and other clinical scales (EDI-3, SCL-90, BUT).


Eligibility Criteria:
Inclusion Criteria:

* Anorexia nervosa
* Severe depression (Hamilton score 25 or higher)
* Written informed consent

Exclusion Criteria:

* Other psychiatric disorders
* Acute infectious diseases
* Chronic inflammatory diseases
* Disorders of central nervous system
* Pregnancy ore breastfeeding
The Effect of Oral Health Education on Knowledge, Attitude, Practice and Dental Caries Among Egyptian School Children

Aim of the study Assessing the effect of an oral health education program on knowledge, attitude, practice, and dental caries among a group of school children in a governmental school in Fayoum, Egypt.

Study type Others: Observational Before and after study

Eligibility Criteria:
Inclusion Criteria:

* School children aged (6 to15) years old.
* Children with or without previous dental experience.

Exclusion Criteria:

* Refusal of participation.
* Children with a mental or physical disability
Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone in Relapse and Refractory DLBCL

Previous study showed that Lenalidomide or R-GDP could achieve response in Relapse and Refractory DLBCL.The investigators therefore design this phase I study to investigate the safety and efficacy of R2-GOD in relapsed diffuse large-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old;
* ECOG PS 0- 2;
* Histologically confirmed diffuse large B cell lymphoma（With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma),relapse or refractory,defined as:

  * relapse after standard first-line immunochemotherapy( R-CHOP or R-CHOP like)
  * SD as best response after 4 cycles or PD after 2 cycles of first-line immunochemotherapy;
* a measurable or evaluable disease at the time of enrollment(diameter ≥ 1.5cm）；
* Eligible for subsequent autologous stem cell transplantation；
* Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures
* Expected survival ≥ 12 weeks；
* Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

* Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures；
* Uncontrollable active infection within four week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons；
* Used of systemic anti-tumor treatment within four weeks；
* CNS or meningeal involvement;
* Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr\< 50 mL/min unless these abnormalities were related to the lymphoma;
* Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 75×10⁹/L, unless caused by bone marrow infiltration;
* New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia；
* Known sensitivity or allergy to investigational Product;
* Major surgery within three weeks;
* Presence of Grade III nervous toxicity within past two weeks;
* Active and severe infectious diseases;
* History of DVT or PE within past 12 months；
* Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment;
* In any conditions which investigator considered ineligible for this study.
The Influence of BMI on Core Stability in Healthy Adults

This study will be conducted to investigate the influence of body mass index (BMI) on core stability (CS) in healthy subjects. The participants in this study will be 90 healthy subjects with right dominant lower limb (49 females and 49 males) they will be recruited from College of Applied Medical Sciences, Jazan University.

Subjects will be categorized according to BMI into three groups:

Group I (normal subjects): 30 individuals (15 male, and 15 female students) with (BMI\<25 kg//m\^2)) Group II (overweight subjects): 30 individuals (15 male, and 15 female students) with (BMI, 25-30 kg//m\^2)).

Group III (obese subjects): 30 individuals (15 male, and 15 female students) (BMI\>30 kg//m\^2)).

Motor control element of CS will be investigated by assessing bilateral static balance with open and close eye, right foot balance test, and dynamic balance test using Prokin System for balance. Data of this study will be statistically analyzed by performing descriptive (Mean and standard deviation) and inferential statistics (One way ANOVA, Unpaired T test) at level of significance p=\<0.05.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects would not have any diseases of the central nervous system.
2. Subjects would not have any orthopedic disorders either of the trunk or the lower limbs in the previous year.
3. None of the subjects has history of balance training ( Erkmen et al., 2010, Li Li, 2012) .

Exclusion Criteria:

1. Sign of foot pain, reduced tactile and thermal foot sensibility.
2. Peripheral neuropathy.
3. A history of previous back or abdominal surgery/injury
4. A history of patellofemoral pain syndrome, plantar fasciitis, and back pain .
5. Limb-length discrepancy, and anterior or posterior tibialis dysfunction.
6. Evidence of a systemic or musculoskeletal disease within the past six months (AlAbdulwahab \& Kachanathu, 2016).
Drug Use Investigation of Somatropin for GHD-ADULTS.

Post marketing drug use investigation of Genotropin for GHD-ADULTS.

All the patients whom an investigator prescribes the first Somatropin should be registered consecutively until the number of subjects reaches target number.

Eligibility Criteria:
Inclusion Criteria:

The patients who were administered Somatropin to treat "Adult growth hormone deficiency (limited to severe type)".

Exclusion Criteria:

Patients not administered Somatropin.
Telephone Intervention in Patients With Acute Coronary Syndrome (ACS) and Diabetes

Hypothesis To investigate whether telephone counselling by nurse educator between clinic visits with particular emphasis on adherence to medications and lifestyle modification in patients with coronary heart disease and diabetes will reduce mortality and hospitalisation rates due to cardiovascular events compared to usual clinic-based care.

Study-design A 2-year multicentre, randomised controlled open study involving 5 HA hospitals in Hong Kong.

Subjects and method One thousand two hundred and sixteen patients admitted to hospital with principle diagnosis of coronary heart disease and known or newly confirmed diabetes on oral glucose tolerance test will be enrolled. Patients in the intervention arm (n=608) will receive telephone intervention between clinic visits by diabetes nurse educator using structured counselling tools with particular emphasis on adherence to lifestyle modification and medications as well as self-monitoring of blood glucose, blood pressure and body weight. Patients in control group (n=608) will not receive telephone intervention. Both groups will be followed up by their usual medical teams in their hospitals upon discharge.

Clinical endpoints Primary endpoint is the composite of death and/or cardiovascular related hospitalisations. Secondary endpoints include hospitalisations due to cardiovascular events, number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the 5 HA hospitals with principle diagnosis of CHD, age 45 years for male and 55 for female
* Presence of diabetes according to the 1998 WHO criteria and no history of unprovoked ketosis and not requiring continuous insulin treatment within 1 year of diagnosis

Exclusion Criteria:

* Patients with terminal malignancy or other life-threatening diseases with less than 3-month expected survival
* Telephone contact not available
* Patients with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Patients who speak non-Cantonese dialect or different language or have conditions that prevent effective communications e.g. patients who are deaf and mute
* Patients who live in nursing home with supervised treatment
* Patients who have participated in another intervention study during the last 1 month and who are enrolled in any intervention studies.
Real World Study on the Efficacy and Safety of Apremilast in Chinese Patients with Moderate to Severe Plaque Psoriasis, a Multi Center, Prospective, Observational Trial（REACT）

This is a multicenter, one-arm, prospective, observational study，intended to assess evaluation of efficacy and safety of Apremilast in Chinese patients with moderate-to-severe plaque psoriasis。During this study, it is expected to collect data at at baseline and weeks 2, 6, 10, 16, and 20 after treatment。


Eligibility Criteria:
Inclusion Criteria:

* Males or females, ≥ 18 years of age at the time of signing the informed consent document；
* Patients with moderate-to-severe plaque psoriasis：Simultaneously meet (1)and (2): (1)PASI≥ 3；(2) DLQI ≥ 6；
* Subject is a candidate for phototherapy and/or systemic therapy
* Patients who wish to be treated with Apremilast and sign the informed consent

Exclusion Criteria:

* Allergy to Apremilast or any component of the study drug；
* Use of phototherapy within 4 weeks prior to randomization；Use of systemic drugs or biologic agents within 4 half-life periods prior to randomization；Patients with inadequate response or intolerance to previous systemic therapy do not need to consider drug washout；
* Currently using potent cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin, etc.)；
* History of substance abuse, suicide attempts, or mental illness；
* Patients who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period；
* Pustular type, erythroderma type and other psoriasis patients；
* Other circumstances that investigators don't consider appropriate to include.
Evaluating an Online Wellness Intervention for Indian College Students

We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with Indian college students. Students will be randomized to the COMET condition or to a wait-list control condition.

Primary outcome measures (depressive symptoms, anxiety symptoms, and subjective well-being) will be measures at two weeks post-intervention, four weeks post-intervention, and twelve weeks post-intervention.

We will evaluate COMET as a universal intervention (using the full sample) and as a targeted intervention (analyzing those who reported elevated depressive symptoms or anxiety symptoms at baseline).


Eligibility Criteria:
Inclusion Criteria: At least 18 years old and a student at a participating university in India.
Nexium Capsules S-CEI for Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes

The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use.

Primary objective To investigate treatment response to NEXIUM in patients with reflux esophagitis (RE).

Secondary objectives

To investigate following items in patients with RE:

1. Patient satisfactory level of the treatment for RE
2. Health-related quality of life (HRQOL)
3. Severity and frequency of RE symptoms reported by physicians
4. Endoscopic healing rate
5. Development of ADRs

Eligibility Criteria:
Inclusion Criteria:

* Patients to be enrolled in this S-CEI must fulfill all the criteria below at the start of the treatment with NEXIUM.

  1. Aged at least 20 years.
  2. Patients who has a current or past history of clinically diagnosed RE
  3. Patients whose answers in the baseline GerdQ include "2-3 days" or "4-7 days" in at least one of the questions Nos 1, 2, 5 and 6.
  4. Patients to whom NEXIUM 20 mg once daily is to be administered for RE
  5. Patients from whom written consent has been obtained.

Exclusion Criteria:

* Patients must not enter the investigation if any of the following exclusion criteria are fulfilled at the start of the treatment with NEXIUM:

  1. Patients whose ability to follow instructions are suspected to be low by physicians
  2. Patients with a past history of hypersensitivity to the ingredients of NEXIUM.
  3. Patients receiving atazanavir sulfate or rilpivirine hydrochloride
  4. Patients who have received NEXIUM within the past eight weeks for treatment of RE
Role of the Endothelium in Stroke-like Episode Among CDG Patients

The aim of the study is to evaluate the role of the endothelial barrier in the occurrence of stroke-like episode. And to study the protein C system on the surface of the endothelium.

The study consists in isolating endothelial progenitor cells in peripheral blood. After blood puncture, PBMC (peripheral blood mononuclear cell) are isolated by Ficoll gradient and then culturing in appropriated medium.

When cells are confluent, investigators can study the endothelial barrier by using permeability assay and transendothelial resistance test (iCELLigence technology).

Then, protein C system will be studied. Indeed, EPCR (Endothelial protein C receptor) and TM (thrombomodulin), are the two receptors responsible for the activation of protein C. The expression of these receptors will be assessed in flow cytometry. The activated protein C is able to interact with the third receptor PAR1 (Protease activated receptor 1) which is responsible for the protective effects of the on the endothelial barrier. The PAR1 expression will be studied in flow cytometry also.

In order to measure the capacity of the protein C system to generate activated protein C investigators will assay an activated protein C generation on the cell surface.

All these assays will be realized in basal condition and in heat stress (42°C), to mimic the stroke-like episode environment. Indeed, stroke-like episodes occur always during febrile illness.

Eligibility Criteria:
Inclusion Criteria:

* patients with CDG molecularly diagnosed
* with stroke-like history or not

Exclusion Criteria:

* rejection to participate in research
Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor

Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, however, that reports an increase in cesarean deliveries with early amniotomy. Due to the small number of studies evaluating this topic, as well as the conflicting results, more research is needed. Additionally, the method of cervical ripening prior to amniotomy should be accounted for, as it may have an impact on the overall labor course. The purpose of this study is to evaluate the impact of early versus delayed amniotomy on time of delivery time from induction to the active phase of labor, as well on total time to delivery and maternal and neonatal outcomes in women undergoing cervical ripening with the Foley balloon.

This will be an unblinded randomized clinical trial. The investigators will recruit 174 pregnant women undergoing induction of labor. Recruitment will occur on the Labor and Delivery unit at the time of induction, after the decision has been made to place a Foley balloon for cervical ripening. Enrolled subjects will be randomized to early or delayed amniotomy.

Subjects randomized to early amniotomy will undergo amniotomy within 2 hours of Foley balloon removal. Subjects randomized to delayed amniotomy will undergo amniotomy at least 4 hours after Foley balloon removal.

Eligibility Criteria:
Inclusion Criteria:

* Age 18
* Singleton pregnancy
* Term gestation (37 weeks gestation)
* Cephalic presentation
* Undergoing labor induction with transcervical Foley balloon

Exclusion Criteria:

* Previous uterine surgery
* Prelabor rupture of membranes
* Severe pre-eclampsia, HELLP, or eclampsia
* HIV, HCV, or HBV
* Heart disease
* Fever (≥38 0C) at admission
* Category II or III fetal heart rate tracing prior to randomization
* Polyhydramnios
* Fetal growth restriction \<3%
* EFW \> 4200 g
* Fetal demise or major congenital anomaly
* Prisoners
Contrast Enhanced Ultrasound With Lumason in Detecting Liver Cancer in Participants With Cirrhosis

This early phase I trial studies how well contrast enhanced ultrasound with sulfur hexafluoride lipid microspheres (Lumason) works in detecting liver cancer in participants with cirrhosis. Contrast enhanced-ultrasounds use contrast agents, such as Lumason, that are injected into a vein in order to help certain organs and tissues show up more clearly on scans. Contrast enhanced ultrasound with Lumason may help doctors more easily find liver cancer compared to ultrasounds without contrast agent.

PRIMARY OBJECTIVES:

I. Determine the accuracy of contrast enhanced ultrasound (CEUS) utilizing contrast agent sulfur hexafluoride lipid-type A microspheres compared to B-mode non-contrast enhanced ultrasound for liver lesion detection, including hepatocellular carcinoma (HCC), in cirrhotic ultrasound (US) patients.

SECONDARY OBJECTIVES:

I. Determine the concordance of CEUS vs. contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads).

OUTLINE:

Within 30 days of routine MRI, participants undergo non-contrast ultrasound of the abdomen. Participants then receive Lumason intravenously (IV) and undergo contrast-enhanced ultrasound of the abdomen over 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide written informed consent
* Diagnosis of cirrhosis based on one or more of the following: histology, US, computed tomography (CT) or MRI showing cirrhosis, +/- lesions seen on CE-MRI

Exclusion Criteria:

* History of hypersensitivity to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason
* Pregnant patients-excluded by history
* Pediatric patients, as pediatric cirrhosis is uncommon