cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT

Allogeneic hematopoietic cell transplantation(Allo-HSCT) is currently an effective treatment for Acute leukemia (AL). Relapse after transplantation, being a main obstacle for patient survival, is so far treated by second transplantation and donor leukocyte infusion (DLI), which seems to have high risk and low survival. Need for a new medication on relapse is urgent. The immunotherapy using Dendritic cells (DCs) combined with cytokine induced killer (CIK) cells holds promise for the adjuvant treatment of AL to eradicate or control residual disease. This randomized study was conducted to evaluate the feasibility and effective of genetically modified DCs combining to CIK immunotherapy in relapse AL after allo-HSCT.


Eligibility Criteria:
Inclusion Criteria:

* AL patients according to the WHO criteria
* expected survival duration of more than 3 months
* age between 8 and 61years

Exclusion Criteria:

* underlying autoimmune disease
* positive serology for HIV infection
* chronic active hepatitis
Consultation-Liaison Intervention for Patients with Depression and Anxiety in Primary Care

The CoLiPri study is a cluster randomized controlled trial funded by the Swiss National Science Foundation to evaluate the clinical and cost effectiveness as well as the implementation of a complex consultation-liaison intervention to help improve symptoms of anxiety and depression of screened patients in primary care. The intervention includes expert consultations, on demand referral for structured mental health diagnostics, psychoeducation and treatment planning, as well as brief psychotherapeutic interventions and triage.

Mental disorders such as depression or anxiety are serious and common health conditions that are highly prevalent in primary care. The primary care sector plays a key role in the treatment of common mental disorders as general practitioners (GPs) set the course for identification, diagnosis, therapy and referral to specialized treatment. The objectives of the CoLiPri study are to implement a complex consultation-liaison service at the intersection between primary and secondary care and to investigate its clinical and cost effectiveness in patients who are identified at primary care practices with elevated symptoms of depression and anxiety. Focus of the complex intervention is on improved collaboration and communication among GPs, mental health experts, and other services involved in the care of patients with common mental disorders. The novel service aims to support the decision-process at primary care practices, to increase access to evidence-based mental health treatment, and to help improve patients' pathways of care. The CoLiPri service for GPs include expert consultations, on-demand patient referral for structured diagnostics, and/or treatment planning, as well as brief psychotherapeutic interventions and triage. The effectiveness and cost effectiveness of the intervention as an add-on to enhanced usual primary care (usual care plus structured depression and anxiety screening) are evaluated in a cluster randomized clinical trial in screened patients with at least mild symptoms of depression and/or anxiety. In case of positive results, the service might serve as a model how to improve multi professional collaboration and clinical resource allocation for better delivery of mental health care.

Eligibility Criteria:
Inclusion Criteria:

* Patients scoring ≥5 on the PHQ-9 and/or scoring ≥5 on the GAD-7
* Presenting and treated at the participating practice
* Sufficient command of the German language
* Individual signed informed consent

Exclusion Criteria:

* Acute suicidality at the time of enrolment according to clinical evaluation
* A history of psychotic symptoms
* Bipolar Disorder Type-I or Type-II
* Acute substance-related and addictive disorder (i.e. as primary diagnosis)
* Severe cognitive impairment or other serious factors causing inability to follow the procedures of the study
Effect of Inpatient Diabetes Management on Outpatient Glycemic Control

The hypothesis of this study is that using hospital admission to identify patients with poorly controlled diabetes (hemoglobin A1c levels \>8%), and intervening during the hospitalization with targeted inpatient diabetes management will improve glycemic control at 3 and 12 months, with inpatient glycemic control, quality of life, and diabetes self-efficacy serving as secondary endpoints.

The study is a randomized, controlled trial of targeted inpatient diabetes management versus usual care in 70 general medical and surgical inpatients over age 18 with type 2 diabetes and hemoglobin A1c levels greater than 8% who are followed in Partners-affiliated primary care practices. In addition, we will enroll a prospective chart review cohort matched for age, sex, and HbA1c level whose course we will follow for one year after discharge to determine the patter of glycemia among patients who are not enrolled in a clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Known diagnosis of type 2 diabetes by history with outpatient prescription of oral hypoglycemic medication or insulin
* Hemoglobin A1c \> 8.0% within the prior 12 months, or if not known, fasting blood glucose greater than 200 mg/dl on sliding scale regular insulin.
* Partners-affiliated primary care physician

Exclusion Criteria:

* Screening HbA1c returns less than 8%.
* Diabetic ketoacidosis (DKA) as a primary reason for admission (admission blood glucose \> 250 mg/dl with arterial pH \< 7.30 or serum bicarbonate level \< 15 mg/dl), or development of DKA during admission.
* Hyperosmolar hyperglycemic syndrome as a primary reason for admission (admission blood glucose \> 400 mg/dl and plasma osmolality \> 315 mOsm/kg.
* Pregnancy, ruled out by urine HCG test at screening after consent is obtained in all women who continue to have menstrual cycles.
* Anemia with hemoglobin \< 9 g/dl, recent blood transfusion, or need for blood transfusion (interferes with interpretation of hemoglobin A1c assay)
* End stage liver disease with prothrombin time \> 15 seconds and albumin \<3 mg/dl
* End stage renal disease: Stage IV (glomerular filtration rate \<30 mg/dl) or V chronic kidney disease
* Treatment with corticosteroids
* ICU transfer
* Inability to self-administer insulin
* Hypoglycemia unawareness: patient lacks sensation of common signs of blood glucose \< 60 mg/dl (tachycardia, diaphoresis, hunger, confusion, fatigue).
* Projected survival \< 1 year
Implementation of Shared Decision Making Model in Psychiatric Rehabilitation Setting

Background:

Shared Decision Making (SDM) refers to a process of health care delivery in which practitioners and clients seeking help with decisions, collaborate to access relevant information and enable client-centered selections of health care resources (1, 2). SDM leads to better treatment adherence and outcomes for people with a medical problem (3). SDM principles have previously been used in psychiatry to improve antipsychotic and antidepressant medication adherence (4, 5); however, these principles have yet to be applied to psychiatric rehabilitation (6).

The current research uniquely aims to test the development and implementation of a SDM intervention for people with psychotic spectrum disorders (e.g., schizophrenia and affective disorder) during the referral process to psychiatric rehabilitation services. The study will be conducted this year using a randomly selected sample from the population of people with psychotic spectrum disorders hospitalized in SHALVATA psychiatric hospital in Israel. It aims to facilitate better treatment and rehabilitation outcomes. It has received the support and approval of the Mental Health Division of the Ministry of Health (MOH) in Israel, the institutional review board (IRB) by the university of Haifa, Israel and a Helsinki committee approval by SHALVATA psychiatric hospital and the MOH in Israel.

References

1. Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: What does it mean?(or it takes at least two to tango). Soc Sci Med. 1997;44(5):681-92.
2. Adams JR, Drake RE. Shared decision-making and evidence-based practice. Community Ment Health J. 2006;42(1):87-105.
3. Joosten EAG, DeFuentes-Merillas L, De Weert GH, Sensky T, Van Der Staak, C. P. F., De Jong, C. A. J. Systematic review of the effects of shared decision-making on patient satisfaction, treatment adherence and health status. Psychother Psychosom. 2008;77(4):219-26.
4. Hamann J, Cohen R, Leucht S, Busch R, Kissling W. Do patients with schizophrenia wish to be involved in decisions about their medical treatment? Am J Psychiatry. 2005;162(12):2382.
5. Hamann J, Langer B, Winkler V, Busch R, Cohen R, Leucht S, et al. Shared decision making for in-patients with schizophrenia. Acta Psychiatr Scand. 2006;114(4):265-73.
6. Drake RE, Deegan PE, Rapp C. The promise of shared decision making in mental health. Psychiatr Rehabil J. 2010;34(1):7-13.


Eligibility Criteria:
Inclusion Criteria:

* adults (over age 18), with severe mental illness signed an informed consent

Exclusion Criteria:

* do not understand Hebrew did not sign an inform consent
COMPETE: A Clinical Evaluation of Chrono Carbostent Carbofilm™ Coated Stent

The COMPETE study is a prospective,randomized,two-arm multi-center clinical trial comparing two commercially available coronary stents: Chrono Carbostent Carbofilm™ Coated vs Driver/Micro-Driver Coronary Stent System. In this study, 204 subjects will be included (2:1 randomization Chrono:Driver/Micro Driver) in 6 Italian sites.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical evidence of ischemic heart disease;
* No clinical and ECG changes suggestive of ongoing acute infarction;
* De novo lesion \> 50% and \<100% diameter stenosis (DS) in native coronary vessels TIMI flow of \>= 1.
* Reference diameter \> 2.5 mm or \< 4.0 mm;
* Patients with a maximum of two coronary lesions to be treated with a maximum of 2 study stents;

Exclusion Criteria:

* Lesion length \> 30 mm;
* Significant (\>50%) stenosis proximal or distal to the target lesions that might impede run off;
* Lesions located in saphenous vein graft;
* Lesions located in unprotected left main;
* Presence of \> 40% stenosis in the left main;
* Ostial lesion;
* Lesion located in a bifurcation;
* Target lesion with visible thrombus;
* Chronic total occlusion;
* Treatment of restenotic lesions;
* Previous implantation of a stent (BMS/DES) in the target vessel.
The Relationship Between Postural Stability, Performance and Trunk Muscle Endurance in Female Athletes

As core stability improves in handball players, ball-throwing speed increases as well. Postural stability is considered as the most important component of athletic performance as it occurs in almost all movement types. No studies have yet evaluated postural stability, performance and trunk muscle endurance in female athletes at the same time and examined the relationship between these parameters.This study aims to identify the relationship between the postural stability, performance and trunk muscle endurance of female athletes in different branches of sports.

A total of 45 female athletes (15 volleyball, 15 handball, and 15 football players) (average age: 22,26 ± 6,43 / BMI: 21,45 ± 2,39) and 15 sedentary females (average age: 24,86 ± 3,02 / BMI: 21,42 ± 1,90) participated in the study. Trunk muscle endurance of the participants was measured with the McGill core endurance tests and the prone bridge test. Postural stability of the participants was evaluated using Biodex Biosway Portable Balance System (950- 460 USA) device. Sportive performance was tested with the vertical jump test and the hexagonal obstacle test.

Eligibility Criteria:
Inclusion Criteria:

* Not being injured in the last 3 months
* Being a professional athlete that does training 5 days a week for the last two years

Exclusion Criteria:

* cardiovascular system diseases
* pregnant women were excluded
Evaluation of Tamsulosin in the Treatment of Ureteral Stones

Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.

Ureteral colic, mainly due to ureterolithiasis, represents 1 to 2% of hospital emergency admissions. When a surgical intervention is not required, usual treatment combines hydration and anti-inflammatory drugs.

Alpha1-blockers, firstly developed as anti-hypertensive drugs, are now also used in the management of benign prostatic hyperplasia, due to their relaxing properties on the urinary tract. The aim of the study is to investigate whether tamsulosin could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis. Patients are randomized to receive either tamsulosin or a placebo in addition to usual treatment until stone elimination. Efficacy is assessed by evaluating the time to spontaneous passage of the stone between day 1 and day 42, the need for surgery and pain recurrences.

Eligibility Criteria:
Inclusion Criteria:

* Adult over 18 years
* Emergency admission for a ureteral colic
* Radio-opaque ureterolithiasis
* Stone of 2 to 7 mm diameter
* Informed written consent

Exclusion Criteria:

* Pregnancy or breast-feeding
* Treatment with alpha or beta-blocker
* Contraindication to tamsulosin (orthostatic hypertension, hepatic failure)
* Complication needing surgery
* Calculi spontaneous passage before randomization
* Patient not available for a 6 week follow-up
Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia

The aim of this study is to assess the sensitivity, specificity, and accuracy of the Resistell Phenotech device in testing antibiotic susceptibility of Gram-negative bacteria (i.e., E. coli or K. pneumoniae) to clinically relevant antibiotics. The study is designed as a prospective, non-interventional, multi-center, single-arm study.

The blood culture samples from bacteremia patients that are positive for E. coli or K. pneumoniae will be tested with the Resistell Phenotech device after strain identification by MALDI-TOF. The results of the Resistell AST will be compared with the results from the disk diffusion tests (all sites use the Kirby-Bauer disk diffusion test), and site dependent tests (VITEK® 2, BD Phoenix™, MicroScan WalkAway system, and/or EUCAST RAST), which are currently the standard AST methods in the microbiology laboratories at the participating sites.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have signed a General Consent form approving use of their residual blood samples for research purposes (applicable at CHUV only)
* Patients who have signed a consent allowing the use of their residual sample (Restprobenerklärung) (applicable at MUI, only)
* Patients over the age of 18 years (\>18)
* Patients with bacteremia considered to be due to E. coli or K. pneumoniae
* Patients whose positive blood cultures were not older than 24 hours at the time of AST start

Exclusion Criteria:

* Patients with documented refusal of the use of biological material for research purposes (applicable at CHUV, only)
* Patients with polymicrobial bacteremia
Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection

Challenges in the treatment of Helicobacter pylori (H. pylori) include increasing antimicrobial resistance and patient's low tolerance to some regimens. Lactobacillus johnsonii (L. johnsonii) and Immunoglobulin Y (IgY) have been shown to decrease the amount and activity of H. pylori in human stomach and can increase patient's tolerance. We conduct a single-center double-masked randomized controlled trial to evaluate the effectiveness of GastimunHp Plus (a product combining L. johnsonii and IgY) in improving the clearance of H. pylori after six to eight weeks of treatment and side effects of H. pylori treatment. H. pylori is tested by C13- or C14-urea breath test.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with gastritis, duodenitis, or peptic ulcer.
* Tested positive with Helicobacter pylori using C13- or C14-urea breath test or urease test.
* Indicated for Helicobacter pylori eradication.

Exclusion Criteria:

* Suspected malignant lesions.
* Children under 10 years of age; pregnant or lactating women.
* Allergic to chicken egg.
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese adults with growth hormone deficiency.


Eligibility Criteria:
Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent - GHD diagnosed for at least 6 months (defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive months (defined as 180 days) at screening - If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator Exclusion Criteria: - Active malignant disease or history of malignancy. Exceptions to this exclusion criterion:1/ Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision 2/ Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's medical records - For subjects with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years:Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of growth must be documented by two post-surgery magnetic resonance imaging (MRI) scans or CT scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to 270 days) prior to randomisation
A Phase 2, Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian (Study 38826)(P06055)(COMPLETED)

The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.


Eligibility Criteria:
Inclusion Criteria:

* Females of couples with an indication for COH and IVF or ICSI;
* \>=18 and \<=39 years of age at the time of signing informed consent;
* BMI \>=18 and \<=29 kg/m\^2;
* Normal menstrual cycle length: 24-35 days;
* Ejaculatory sperm (use of donated and/or frozen sperm is allowed);
* Willing and able to sign informed consent.

Exclusion Criteria:

* History of/or any current (treated) endocrine abnormality;
* History of ovarian hyperstimulation syndrome (OHSS);
* History of/or current polycystic ovary syndrome (PCOS) or current polycystic ovaries according to USS (at least 10 follicles of 2-8 mm in each ovary);
* More than three unsuccessful COH cycles since the last established ongoing pregnancy (if applicable);
* History of non- or low ovarian response to FSH/hMG treatment;
* Any clinically relevant hormone value outside the reference range during the early follicular phase (menstrual cycle day 2-7) as measured by the local laboratory (FSH, LH, E2, P, total T, TSH and prolactin):
* Any clinically relevant abnormal laboratory value;
* Less than 2 ovaries;
* Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
* Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
* Epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease;
* History of presence of alcohol or drug abuse within 12 months prior to signing informed consent;
* Previous use of Org 36286;
* Use of hormonal preparations within 1 month prior to randomization;
* Hypersensitivity to Org 32489 (Puregon®) and/or Org 37462 (Orgalutran®) and/or Pregnyl® or any of their components;
* Administration of investigational drugs within three months prior to signing informed consent.
Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier

The goal of this observational study is to learn how a physician uses the results of the Percepta® Nasal Swab test to manage people with a newly identified pulmonary nodule.

The main questions it aims to answer are:

* Does the use of the Percepta Nasal swab test reduce the number of invasive procedures in people with a low-risk result and whose nodule is benign?
* Does the use of the Percepta Nasal swab test decrease the time to treatment in people with a high-risk result and whose nodule is cancer?

Participants will be randomly assigned to either a group where the test result is provided to the physician (test arm) or to a group where the test result is not provided (control arm). Researchers will compare management of participants in the two groups.

This is a prospective, multicenter, randomized study to evaluate the clinical utility of the Percepta® Nasal Swab classifier in managing patients with pulmonary nodules identified incidentally or by lung cancer screening. Patients will be randomized to either the test group, where the test result will be returned to the physician to incorporate into decision-making on how to manage the patient's nodule, or the control group which will represent the standard of care where the result will not be returned to the physician. The study will observe and evaluate how the addition of the Percepta Nasal Swab classifier result impacts current management of newly identified lung nodules.

The study will enroll approximately 2400 participants meeting eligibility criteria at up to 100 centers in the US. Enrollment is expected to take approximately 24 months and participants will be followed for 24 to 30 months or until a diagnosis of lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Able to tolerate nasal epithelial specimen collection
* Signed written Informed Consent obtained
* Subject clinical history available for review by sponsor and regulatory agencies
* New nodule identified on imaging \< 90 days prior to nasal sample collection
* CT report available for index nodule
* 29 - 85 years of age
* Current or former smoker (\>100 cigarettes in a lifetime)
* Pulmonary nodule ≤30 mm detected by CT

Exclusion Criteria:

* Active cancer (other than non-melanoma skin cancer)
* Prior primary lung cancer (prior non-lung cancer acceptable)
* Prior participation in this study (i.e., subjects may not be enrolled more than once)
* Current active treatment with an investigational device or drug
* Patient enrolled or planned to be enrolled in another clinical trial that may influence management of the patient's nodule
* Concurrent or planned use of tools or tests for assigning lung nodule risk of malignancy other than clinically validated risk calculators