cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Pulmonary Langerhans Cell Histiocytosis

ECLA is a phase II, multicenter study testing sub cutaneous cladribine 0.1mg/kg/j during 5 days, administrated every month for 4 courses, in symptomatic adult patients with pulmonary Langerhans cell histiocytosis and impairment of lung function patients.

ECLA is a phase II, multicenter study testing sub cutaneous cladribine 0.1mg/kg/j during 5 days, administrated every month for 4 courses, in symptomatic adult patients with pulmonary Langerhans cell histiocytosis and impairment of lung function patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 16 to 55 yr
* Histologically proven pulmonary Langerhans cell histiocytosis ( patients with presumptive diagnosis whose lung function precludes lung biopsy may be included after revision of their medical record at the national reference center for Langerhans cell histiocytosis)
* Symptomatic pulmonary Langerhans cell histiocytosis (NYHA dyspnea class ≥2) with:

  * irreversible airflow obstruction (FEV1/FVC\<70%) with postbronchodilator FEV1 comprised between 30 and 70% of predicted
  * and/or decrease ≥15% in FEV1, FVC or DLCO as compared to baselines values in the year preceding the inclusion
* Signed written informed consent

Exclusion Criteria:

* Women at childbearing age without adequate contraception or wishing breastfeeding
* Male without adequate contraception during the study
* Dyspnea due to severe pulmonary arterial hypertension (PAP≥35mmHg) confirmed by cardiac right catheterism
* Previous malignancy
* Current infectious disease
* Renal failure
* Liver failure
* Severe alteration of lung
* Hematologic disease unrelated to Langerhans cell histiocytosis
* Epilepsy
* Hepatic, spleen or hematology involvement by Langerhans cell histiocytosis
* Pneumothorax within a month previously to inclusion
* Previous treatment with cladribine
* Contra indication to the use of cladribine
* Previous myelosuppressive treatment
* Simultaneous participation to another interventional clinical trial
Alcohol & Men's Sexual Risk Behaviors

This project extends the investigators' previous research regarding the intersecting risks of alcohol, sexual risk behavior (SRB), and sexual aggression (SA) in male drinkers who have sex with women by examining the mediating and moderating roles of both intrapersonal and interpersonal emotional factors. While independent streams of research consistently document alcohol's role in SRB and SA, the investigators' work has demonstrated that these behaviors are related, and that alcohol exacerbates their likelihood both independently and synergistically. The researchers' investigations focus on a particular type of SRB: men's resistance to condom use with female partners who want to have protected sex. Condom use resistance (CUR) is common and normative among young male drinkers, with up to 80% of men reporting engaging in CUR. Of particular concern, research demonstrates that up to 42% of men report using coercive CUR tactics such as emotional manipulation, deception, condom sabotage, and force to obtain unprotected sex. Investigators will evaluate hypotheses that distal and proximal emotional and alcohol factors influence in-the-moment SRB/CUR intentions as well as daily alcohol use and SRB/CUR. The investigators will also examine whether the relationships among assessed variables are similar across experimental and naturalistic settings. That is, investigate the extent to which men's responses in the lab parallel their real-world drinking and SRB/CUR behaviors, particularly regarding self and partner emotions, empathy, and interpersonal stress.


Eligibility Criteria:
Inclusion Criteria:

* Single
* Male
* Ages 21-30
* Engagement in unprotected intercourse with a woman at least once in the past year
* Consumed alcohol at least 2 times per week in the past 30 days
* Had sex with a woman at least 2 times in the past 30 days

Exclusion Criteria:

* A history of alcohol problems
* A medical condition and/or medications which contraindicate alcohol consumption
* In a relationship that is monogamous and has lasted longer than 6 months
Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases

Acquired inflammatory or infectious cardiac diseases, in pediatrics, include Kawasaki disease, myocarditis, and Covid-19-related Pediatric Multisystemic Inflammatory Syndrome (PIMS).

These 3 inflammatory cardiac diseases have clinical, biological, and echographic similarities and differences. Nevertheless their modalities of monitoring, management and evolution are different. The investigators wish to retrospectively analyze biological and echocardiographic data of Kawasaki disease, myocarditis, PIMS patients managed at Nancy Children Hospital from January 1, 2017 to June 31, 2023.

The primary objective of this study is to identify, for these 3 pathologies, the prognostic factors of initiation of inotropic support.

The secondary objective is to identify the prognostic factors of degradation of ventricular function.


Eligibility Criteria:
Inclusion Criteria:

* diagnostic of PIMS, myocarditis or kawasaki disease patients
* age \< 18 years

Exclusion Criteria:

* uncertain diagnosis
* other complex heart disease
* management out of Nancy University children hospital center
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Insulin (IN-105) in Type 1 Diabetes Patients

The purpose of this study is to see whether IN-105 (oral insulin) is able to control increase in blood glucose after eating a meal. This study will also tell whether single tablet of IN-105 is safe for patients with Type 1 diabetes mellitus who are currently taking insulin injections.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients between the ages of 18-45 years inclusive
2. Established diagnosis of T1DM for at least 1-year
3. Body mass index of 18.5-29.9 kg/m2 inclusive
4. Stable weight with no more than 5 kg gain or loss within 3 months of screening
5. HbA1c ≤ 8.0%
6. On stable insulin or an insulin analogue regimen for at least 3 months

Exclusion Criteria:

1. Any hypersensitivity or allergy
2. Positive urine ketones test at screening visit.
3. ECG abnormality
4. total daily insulin \>1 IU/kg and/or \>0.7 IU/Kg of basal insulin and/or \>0.6 IU/Kg of prandial insulin.
5. Patient with a clinically significant abnormality
6. Evidence of severe secondary complications of diabetes
7. History of drug or alcohol dependence or abuse
8. Patients currently on systemic or inhaled glucocorticoids or other drugs, which may affect glycemic control.
9. Patients treated with blood-glucose lowering drugs other than insulin or insulin analogues in the last 4 weeks prior to screening or during the study
10. History of two or more severe episodes of hypoglycemia (defined by ADA criteria) within 6 months prior to screening and/or patients with history of low blood glucose level episodes suggestive of hypoglycemia unawareness (loss of warning symptoms of hypoglycemia). Investigator to assess this criterion based on the subject filled questionnaire.
11. Any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening.
12. Impaired hepatic function (ALT or AST value greater than 2 X Upper limit of reference range and/or serum bilirubin ≥1.5 X Upper limit of reference range at the screening visit).
13. Impaired renal function (serum creatinine ≥1.5 X Upper limit of reference range at screening).
14. Hemoglobinopathies, haemolytic anaemia, anaemia of chronic disease, or any factor affecting the measurement of HbA1c.
15. Any electively planned surgery requiring hospitalization during the study period.
16. Pregnancy, lactation, or planned pregnancy during the study duration.
17. The patient has received another investigational drug within 6 weeks prior to screening
18. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
The Effect of Fatigue on the Clinical Performance

The primary aim of this randomized controlled trial is to examine the effect of fatigue on clinical performance in a simulated obstetric emergency. This scenario was chosen because it is a common clinical situation faced by anesthesia providers on call and therefore likely to occur when a provider is fatigued. Secondary outcomes will include the evaluation of other factors that worsen fatigue related decrement in performance including age, years of training/practice and clinical load prior to study participation.


Eligibility Criteria:
Inclusion Criteria:

* All attending anesthesiologists taking overnight call at Evanston Hospital will be eligible participants.

Exclusion Criteria:

* Resident physician or trainee, physician not taking overnight in house call.
A Research Study, Looking at the Characterization of Treatment Intensified (Add on to Metformin) Real-world Adult Population With Type 2 Diabetes Mellitus in India, Pakistan and Thailand.

This study aims to describe demographics, clinical, treatment and healthcare resource utilization characteristics with a particular focus on those relating to cardiovascular disease in selected treatment intensified patients with type 2 diabetes in the real-world settings in India, Pakistan, and Thailand.

The study will be based on data already recorded in participants medical record and no new tests or procedures are required as part of the study.

The study will last for about 6 months and it does not affect participants current treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal to 18 years at type 2 diabetes mellitus (T2DM) diagnosis
3. Year of birth 1928 or later (age blow 90 years old in 2017)
4. T2DM diagnosis in medical record on or after the date of local GLP-1 RA marketing authorization
5. Medical records documenting prior or ongoing treatment with metformin
6. Medical records documenting treatment with other non-metformin T2DM drugs

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
3. Patients with any diagnosis of type 1 diabetes mellitus (T1DM)
Defining Predictors of RT Response to Vedolizumab in IBD

The overall goal of the study is to develop data that can convincingly guide clinicians on the use and efficacy of vedolizumab in patients with small bowel CD. There is an unmet need to identify response to vedolizumab in small bowel CD using objective endpoints. Current data suggest that MR enterography may meet this unmet need. There is an additional unmet need to develop predictive models incorporating both clinical and baseline radiological and endoscopic variables with higher discriminatory performance in identifying longer term clinical remission with vedolizumab. Finally, this proposal is strengthened by the exploratory studies which may identify new proteomic biomarkers that correlate with longer term radiological response with vedolizumab reflecting its latency of response. If successful, these serum biomarkers may guide a personalized approach to the treatment of small bowel CD with vedolizumab, allowing early identification of PNR, monitoring disease activity and the pharmacodynamics of vedolizumab.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe disease activity small bowel CD (small bowel only or ileocecal only) visible on MRE
* Initiated on Vedolizumab with/without thiopurines or methotrexate
* ≥18 years old

Exclusion Criteria:

* Pregnancy
* Age \<18
* Planned surgery prior to the first follow-up MRE
* Inability to provide informed consent.
* Perianal CD will be excluded since assessment requires performance of additional MRI of the pelvis.
* Individuals with colonic involvement other than involvement of the ascending colon and cecum.
* Inpatient scans will only be included if this is a MRE and adequate small bowel distension with appropriate contrast has been achieved
* If unable to provide informed consent
* Contraindications for MRE including chronic kidney disease that precludes contrast administration, implanted medical devices that are contraindicated for MRE.
Botulinum Toxin for Stomach Cancer Treatment

Preclinical studies at our institution, using a genetic mouse model of gastric cancer, strongly suggest that innervation of the stomach wall is required not only for the development, but also for the progression of gastric cancer, and that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall may represent an effective therapeutic intervention. New treatment options for inoperable cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to be an attractive possibility. In this pilot study Botox injections will be given by gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is to obtain data needed to calculate sample size in a larger controlled trial.


Eligibility Criteria:
Inclusion criteria:

Patients with verified gastric adenocarcinoma but found non-resectable or inoperable after evaluation in the appropriate multidisciplinary team at St.Olav Hospital. Trondheim University Hospital. The inclusion criteria for such patients are:

1. Patients who have received 1.line and 2. line chemotherapy but no longer respond to such therapy.
2. Patients who, due to toxicity of chemotherapy, cannot be offered such treatment.
3. Patients who, after meticulous information about chemotherapy, still do not want such treatment.
4. Patients with performance status (ECOG) 0-2.

Exclusion criteria:

1. Known allergy to any of the components in Botox®
2. Known peripheral motor neuropathy disease ( for example: Amyotrophic Lateral Sclerosis, ALS), or subclinical or clinical deficiency of neuromuscular transmission (for example: Myasthenia Gravis or Eaton-Lambert's Syndrome).
3. Pregnant or lactating women.
4. Another cancer disease that is not under control.
5. Another concomitant treatment for cancer.
6. Serious mental illness.
7. Performance status (ECOG) 3-4.
Family Preventive Visits to Detect Risk Factors in the Family

The purpose of this study is to determine whether a systematic family assessment in adult preventive health visits increases the detection of risk factors in the spouse or adolescent child of the screened person.


Eligibility Criteria:
Inclusion Criteria:

* Parents of adolescents between 14-17 years.

Exclusion Criteria:

* Living with single parents.
* Does not accept participating in the study.
Comparing the Prognosis of Patients With HCC and PVTT Treated With Surgery Versus Locoregional Therapy.

Hepatocellular carcinoma is prone to invade the portal vein and form portal vein thrombosis, and patients in this period are directly included in the advanced stages, i.e. Barcelona clinical liver cancer stage C. For the treatment of PVTT, there are differences between Eastern and Western guidelines, with systemic drugs being the standard of care in Western countries, while surgical treatment is often actively practiced in the Asia-Pacific region. More research is needed to explore the differences between these two approaches.

Hepatocellular carcinoma is prone to invade the portal vein and form portal vein thrombosis, and patients in this period are directly included in the advanced stages, i.e. Barcelona clinical liver cancer stage C. For the treatment of PVTT, there are differences between Eastern and Western guidelines, with systemic drugs being the standard of care in Western countries, while surgical treatment is often actively practiced in the Asia-Pacific region. In recent years, breakthroughs have been made in the treatment of advanced HCC, and systemic drug combinations such as PD-1 inhibitors combined with targeted therapies, and local area therapy combined with systemic therapy have shown excellent anti-tumor effects. Postoperative adjuvant therapy is also advancing, and the combination of adjuvant systemic medications for patients after PVTT has also been effective in reducing postoperative recurrence. Which approach is better for PVTT patients needs to be explored in depth.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years
* Pathological type is HCC, and with PVTT
* No extrahepatic HCC
* Eastern Cooperative Oncology Group (ECOG) performing status of 0-1 and Child-Pugh grade A for the liver resection group
* ECOG performing status of 0-2 and Child-Pugh grade A-B for the locoregional-based group
* Adequate hematologic and organ function

Exclusion Criteria:

* Any history of other malignant tumors or recurrent HCC
* Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
* Any persistent serious liver resection or locoregional therapy-related complications
* Esophageal and/or gastric variceal bleeding within 6 months
* Inability or refusal to comply with the treatment and monitoring
* Participation in other clinical trials
Cost-effectiveness of EGDT Using FloTrac/EV1000

Coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB) is a high-risk surgery with significant morbidity that results in a prolonged stay in the intensive care unit (ICU) at an increased cost. Early goal-directed therapy (EGDT) using the FloTrac/EV1000 platform improved outcomes in these patients with shorter ICU stay but with extra cost for a FloTrac transducer. The objective of this study is to assess the cost-effectiveness of implementing the FloTrac/EV1000 in these patients.

EGDT using FloTrac/EV1000 platform has been reported to improve outcomes in patients undergoing CABG with CPB resulting in a reduction in cardiovascular and thoracic ICU (CVT ICU) and hospital stay. However, the use of the FloTrac sensor has an extra cost that impedes its implementation. There is still no study that assesses the cost-effectiveness of implementing FloTrac in cardiac surgery.

The objective of our study is to evaluate the cost-effectiveness of applying EGDT using the FloTrac/EV1000 platform in patients undergoing CABG with CPB.

There are 2 steps in this study:

1. Assessing the efficacy of the FloTrac/EV1000 platform
2. Assessing the daily CVT ICU cost

Assessing the efficacy of the FloTrac/EV1000 platform

We compare the efficacy of the FloTrac/EV1000 versus standard practice. The sample size of 30 patients per group was calculated based on data from a previous study, an α value of 0.05, a β value of 0.2, and a 30% decrease in ICU stay. Sixty patients undergoing CABG with CPB at Srinagarind Hospital or Queen Sirikit Heart Center of the Northeast between July 2018 and June 2020 will be recruited. They will be divided into 2 groups: EV1000 and Control. The intraoperative hemodynamic optimization in the EV1000 was managed using goal-directed therapy via the FloTrac/EV1000 platform and the Control was managed using a standard protocol as described in the study of Tribuddharat et al. The extracted data for comparison were: demographic and clinical data, CVT ICU stay, ventilator time in CVT ICU, postoperative complications, and hospital stay. The ICU stay of both groups will be compared.

Assessing the daily CVT ICU cost

We will evaluate the ICU cost of the CVT ICU of Srinagarind Hospital by recruiting another group of patients who were admitted to the CVT ICU during October 2021 to identify the average daily cost. The cost of a FloTrac sensor and the ICU cost saved will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who underwent CABG with CPB.

Exclusion Criteria:

* Patients who required an intra-aortic balloon pump or extracorporeal membrane oxygenator.
Turkish Validity and Reliability Study of Virtual Reality Sickness Questionnaire

This study is planned for the cultural adaptation and validity of the "Virtual Reality Sickness Questionnaire".

Virtual reality (SG) creates a virtual environment that reflects a real environment and offers various experiences to users. Motion sickness can be observed in people after using virtual reality applications or simulation devices in education. There are questionnaires in the literature such as "Simulator Sickness Questionnaire" and "Motion Sickness Questionnaire". However, these questionnaires are specific surveys to evaluate symptoms that develop after vehicle handling or use of simulation devices for pilot training, while they are not ideal questionnaires to evaluate symptoms that may develop after virtual reality applications. Because there are important differences between virtual reality systems and simulation systems in terms of the appearance of motion disturbance symptoms. For this reason, "Virtual Reality Sickness Questionnaire" has been developed that can evaluate these symptoms.

There is no Turkish version of the "Virtual Reality Sickness Questionnaire" in the literature. For this reason, this study is planned for the cultural adaptation and validity of the "Virtual Reality Sickness Questionnaire".

Eligibility Criteria:
Inclusion Criteria:

* Not having mental - cognitive problems,
* Being a volunteer

Exclusion Criteria:

* Oculomotor and vestibular disease
* Cardiovascular, neurological and gastrointestinal problems
Naltrexone as Adjunct in Alcoholic Cocaine Dependent Patients - 4

The purpose of this study is to evaluate naltrexone as an adjunct in alcoholic cocaine dependent patients; concurrent relapse prevention theory.


Eligibility Criteria:
Please contact site for information.
Efficacy of SynEx Wound Rinse in Civilian Surrogates of Combat Injury Wounds

The purpose of this interventional study is to compare SynEx Wound Cleanser with the current routine care (Saline) in traumatic wounds. Participants with gunshot, penetrating or burn wounds who participate will be asked to attend up to four study visits, use the assigned wound cleanser and complete brief surveys about their healing and well-being related to the wound healing.


Eligibility Criteria:
Inclusion Criteria:

1. Acute penetrating, puncture and burn wounds of the upper or lower extremity that meet the inclusion and exclusion criteria for the wound type:

   1. Penetrating, puncture or laceration wounds: stage II-III (partial to full thickness loss of dermis) excluding diabetic or venous wounds, and pressure ulcers and perforated wounds (except gunshot wounds) and wounds with exposed bones, facia or muscle.
   2. Gunshot wounds (GSW): Grade I - II on the Red Cross Classification of War Wounds6 (diameter of entry + exit wounds \< 10 cm, wound cavity or not, no fracture or fraction without clinically significant comminution). Non-penetrating, penetrating, or perforated GSW are included. GSW with suspected vascular injuries or nerve damage are excluded.
   3. Burns: partial thickness injury ≤ 9% TBSA. Thermal burn from flame or scald, chemical burns, and electrical burn are included. Radiation and frostbite burns are excluded.
2. Males and females ≥18 years old.
3. Has access to a computer or mobile device for telepresence visits.
4. Able to give informed consent and willing to comply with all required study procedures.

Exclusion Criteria:

1. Any wound likely to require irrigation and debridement in an operating room (OR) setting.
2. Concomitant processes sustained contemporaneously with the dermal injury (e.g., inhalational injury requiring ventilation, electrical injury with cardiac damage or arrhythmia, sepsis, traumatic brain injury, other serious or unstabilized organ damage from trauma, etc.).
3. \> 72 hrs from initial injury.
4. Pregnant or lactating females.
5. Patients with known allergy(ies) to any of the components of the study irrigation system.
6. Patients who are considered by the investigator for any reason to be an unsuitable candidate.