cyrilzakka/clinical-trials huggingface dataset:
Dose Reduced Dasatinib (70 mg Daily) as First-line Treatment for Newly Diagnosed CML-CP

The purpose of this study is to explore the efficacy and safety of dasatinib 70 mg once daily as first line therapy in patients with early chronic phase (CP) chronic myeloid leukemia (CML).

A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of 70mg dasatinib by measuring rates of major molecular response (MMR) at 12 months in patients with CML-CP in China. Approximately 65 Patients will be recruited consecutively from the study sites during the enrollment period and will be given dasatinib 70 mg QD. The duration of patient participation will be 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Diagnosis of Ph+ or BCR-ABL positive CML-CP within 6 months.
* ECOG performance of 0-2.
* Adequate end organ function defined as the following: total bilirubin \<1.5x ULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN.
* Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital

Exclusion Criteria:

* History of any TKI treatments.
* History of Pulmonary arterial hypertension and Pleural effusion
* NYHA cardiac class 3-4 heart disease.
* Cardiac symptoms - Patients meeting the following criteria are not eligible unless cleared by a cardiologist:
* Uncontrolled angina within 12 months.
* Diagnosed or suspected congenital long QT syndrome.
* Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes).
* Prolonged QTc interval on pre-entry electrocardiogram (\>450 msec).
* Patients with active uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders.
* Women of pregnancy potential must practice an effective method of birth control, unless otherwise instructed, during the course of the study in a manner such that risk of failure is minimized.
* Pregnant or breast-feeding women are excluded.
* Patients in late chronic phase (i.e. time from diagnosis to treatment \>12 months), accelerated phase (except as noted in inclusion criteria 2) or blast phase are excluded.
Evaluation of the Physicians and Patients Experience of Fetal Scalp Sampling

During labor, fetal scalp sampling is performed if the CTG registration is abnormal. The test is performed with the woman in the supine position and is generally described as a difficult and cumbersome procedure.

Women who were subjected to fetal scalp sampling are asked to fill in a questionnaire within 24 hours after delivery. The questionnaire deals with how the woman experienced the testing procedure.

Physicans who performed the test are asked to fill in a questionnaire within 24 hours after delivery. The questionnaire deals with how the physician experienced the testing procedure.

Eligibility Criteria:
Inclusion Criteria:

* fetal scalp sampling during labor

Exclusion Criteria:

* non-proficiency in the Swedish language
Laser Therapy in Women With Lichenoid Disorders

Primary aim of the trial is to compare improvement of lichen symptoms according to a composite VAS scale (burning, itching and pain) between women with vulvovaginal laser therapy vs. sham laser therapy at three months.

Background: Lichenoid Disorders (LD) include VLS (Vulvar lichen sclerosus) and LP (Lichen planus). VLS and LP are chronic skin diseases that usually affect the anogenital region. Both can cause vulvar itching, burning and pain and can lead to urinary and sexual dysfunction. Current treatment options are unsatisfactory. Vulvovaginal laser therapy might be an effective treatment option.

Study aim: To study the effectiveness of non-ablative vulvovaginal laser therapy for women with lichenoid disorders.

Design: Randomized double-blinded placebo- controlled clinical study

Study Population: Women diagnosed with LD will be recruited from a specialized University outpatient clinic.

Study groups: Participants will be randomized (1:1). Intervention group: Laser therapy (2 treatments), plus ongoing therapy Control group: Sham laser therapy (2 treatments) plus ongoing therapy

Sample size Total 40 patients Primary study outcome: Visual analogue scale (VAS) composite score in regard to LD Secondary study outcomes: quality of life (QoL) (Skindex questionnaire); Treatment discomfort/ pain (VAS); Patient treatment satisfaction (Questionnaire to ask for treatment satifsaction: ZUF-8); Subjective improvement (Patient global impression of improvement- PGI-I), clinical LS score, histological appearance

Eligibility Criteria:
Inclusion criteria

* women age \>18 years
* diagnosed with LD (VLS or LP histologically proven)
* Clinical LS score ≥ 4 based on the score of Günthert et al. \[1\]
* Normal Pap-smear within 24 months
* negative clinical and microscopic evaluation of vaginal fluid
* Negative test for STD (sexually transmitted diseases) pathogens (chlamydia, gonorrhea, genital mycoplasma and trichomonas) if symptomic including abdominal pain or abnormal vaginal fluid
* Good German language skills
* written informed consent
* preceding local corticoid therapy of at least 12 weeks according to the current guideline for LD

Exclusion criteria:

* women with contraindications for the use of laser on the skin
* pregnancy
* presence of vulvar pathology (other than lichen)
* any vulvar/ vaginal infection
* immunocompromised women
* swollen lymph nodes
* genital malignant disease
* allergy to topical anaesthesia
* connective tissue disease
* keloid formation
* Patients with a legal guardian
* Body Mass Index \> 35 kg/m²
* History of transvaginal mesh implant (excluding sling or sacrocolpopexy mesh)
* Coagulopathy
* patients using anticoagulants
* patients with renal, hepatic or pulmonary-cardiovascular failure
* patients who have undergone any kind of organ transplantation in the last three years.
Atelectasis by Lung Ultrasonography in Cesarean Sections

In this study aimed to demonstrate that atelectasis developing in the perioperative period of patients undergoing elective cesarean surgery with spinal or general anesthesia methods using lung ultrasound. After Preoperative lung ultrasounds of patients is done, the cesarean operation will be completed with spinal or general anesthesia. In the postoperative period, control lung ultrasounds will be performed and the ultrasound results will be compared in terms of atelectasis in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Between 18-40 years
* 37-40 weeks pregnant
* ASA II because of pregnancy

Exclusion Criteria:

* Emergency cesarean sections
* who refuse to participate in the study
* with chronic disease
* Smoker
* with chest deformity
Macroscopic on Cite Evaluation of EUS-FNA Specimen With 22 G Needle

In order for the diagnosis of digestive system tumors and their appropriate treatment afterward, the type of these tumors should be determined by the pathologist. Pathology doctors need sufficient tissue (a small part of the organ thought to be diseased) to make a diagnosis. Tissue samples were taken from the patients by biopsy procedure. It is examined with microscopes by performing various staining and occasionally it is reported that sufficient tissue cannot be provided to make a diagnosis. In this case, patients may be subjected to repeated biopsy procedures. The aim of this study is to investigate whether the biopsy material obtained by endoscopic ultrasonography (EUS) is sufficient for the diagnosis of the pathology physician with the naked eye. Researchers will try to determine to what extent the physician performing the biopsy procedure can predict whether the tissue he has obtained is sufficient for the pathologist. In this way, researchers think that fewer biopsy repetitions will be needed in the future.

This study was designed to improve the acquisition of sufficient tissue (EUS-FNA) with endosonography-assisted fine needle aspiration biopsy, which has been approved and used worldwide for the diagnosis of digestive system diseases. The procedure to be applied in the study is to determine the visible tissue fragments in the sample to be taken after the standard EUS-FNA procedure and to compare it with the diagnosis made by the pathologist. Patients with a tumor detected in the digestive system and referred to the investigation unit for tissue diagnosis will be included in this study. The data obtained in the study will be collected prospectively and will be analyzed retrospectively.

Eligibility Criteria:
Inclusion Criteria:

1. İn the age range of 18-80 years old
2. Tumour detected withcross-sectional imagined technics in the digestive system

Exclusion Criteria:

1. Refuse to give written informed consent
2. Established bleeding disorder
3. INR\>1.5IU plaelet count \<100000/dL
Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria

The purpose of this research is to study new ways of classifying mental disorders in children based on observable behavior and genetics to ultimately diagnose these disorders better.

The NIMH Research Domain Criteria (RDoC) initiative seeks to further a long-range goal of contributing to diagnostic systems as informed by research on genetics, neuroscience, and behavior. The RDoC approach is based on identifying the most elemental units of analysis relevant to psychiatric disorders (such as genes and molecules) and using this matrix as a framework for investigation. In this case-control family study, the investigators will be using self-report questionnaires and computer-based tests to develop diagnostic methods for neuropsychiatric disorders in children, their siblings, and their parents. They will do this by recruiting "normal" and "affected" children, their siblings, and their parents. They will look at the subject, sibling, and parents to determine if psychiatric disorders are inherited. "Affected" children, ages 6-12, are those who have been diagnosed with a psychiatric disorder. Participants will undergo a battery of questionnaires/evaluations and a blood draw. The investigators will determine if the questionnaires and tests that reflect the constructs (such as reward prediction and willingness to work) predict psychopathology and impairment. The blood draw will be genotyped to determine if the measured constructs are associated with neuropsychiatric candidate genes, cross-disorder candidate gens and a cross-disorder polygenic score.

Eligibility Criteria:
Inclusion Criteria:

* male or female, ages 6-12.
* biological child of parent(s) participating in testing.

Exclusion Criteria:

* taking psychotropic medications.
* free of uncontrolled medical problems.
* major sensorimotor disability (e.g., deafness, blindness).
* diagnosed neurological condition.
* inadequate command of the English language.
* history of head injury with loss of consciousness lasting longer than 10 minutes.
* IQ estimated at below 80.
A Study for the Treatment of Hormone Refractory Prostate Cancer (HRPC) in Patients Previously Treated With Chemotherapy

A study for the treatment of hormone refractory prostate cancer (HRPC) in patients previously treated with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed prostate cancer.
* Prior chemotherapy regimen for prostate cancer

Exclusion Criteria:

* History of other malignancy in the last 5 years
* Major surgery within the past 21 days
A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee

To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of the knee.

This is a randomized withdrawal design study, containing a 4 week open-label period followed by a 6 week double-blind period. The total treatment period will be 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* History of osteoarthritis (OA) of the knee joint and meeting American College of Rheumatology (ACR) Clinical and Radiographic criteria,
* Currently taking nonsteroidal anti-inflammatory drugs (NSAIDs) and still experiencing pain as per the protocol requirements.
* Willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures.

Exclusion Criteria:

* Diagnosis of rheumatoid arthritis, autoimmune disorder, arthritis other than osteoarthritis involving the study joint, or other painful syndrome that could interfere with the assessment of pain at the study joint
* Any cardiac, respiratory, neurological, psychiatric disorder or any other medical condition or illness that is not well controlled with treatment
Emotion Regulation Group Treatment for Gambling Disorder - a Pilot Trial

Group cognitive behavioral therapy for Gambling Disorder (GD) with a focus on emotion regulation - A pilot study This pilot study will evaluate the feasibility and possible effectiveness of a novel treatment protocol developed within the research group including emotion regulation techniques for the treatment of GD.

The manual is based on principles from so called third wave cognitive behavioral therapy, which differs from current treatment within standard care in that focus is more on emotion regulation techniques. The treatment consists of an 8- session program delivered by weekly sessions. The study is an open trial in order to evaluate the possible benefit of components of emotion regulation in treating gambling disorder (GD). Participants with psychiatric comorbidities will be included and symptoms of comorbidities will be measured as secondary outcomes.

Once included in the study the participant will be measured weekly on symptoms of gambling disorder.

By increasing competencies in emotion regulation (such as active problem solving, acceptance and reappraisal of events in order to change their emotional impact) the hypothesis is that the participants will improve on measures of symptoms of GD as well as gambling expenditure in terms of time and money.

Eligibility Criteria:
Inclusion Criteria:

* Gambling Disorder according to DSM 5

Exclusion Criteria:

* Unable to speak and read Swedish
* Symptoms of manic episode
* Severe psychiatric condition in need of urgent care
Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants

This study is researching experimental drugs called REGN9933 and REGN7508 (called "study drugs") and comparing their effects to approved treatments of rivaroxaban and aspirin (called "standard treatments"). Aspirin will be given alone or in combination with the study drugs or the other standard treatments to look at their effects on blood loss in the intestines.

The aim of the study is to see if aspirin alone or the study drugs REGN9933 and REGN7508, when taken with aspirin, cause less minor intestinal bleeding than standard treatments rivaroxaban with aspirin.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)


Eligibility Criteria:
Key Inclusion Criteria:

1. Body mass index between 18.0 and 32.5 kg/m2 (inclusive) at the screening visit
2. Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study treatment
3. Normal aPTT, normal PT, and normal platelet counts at screening period and at the day 1 visit as defined by the local laboratory
4. Hemoglobin values within the normal range, per local laboratory, at the screening and day 1 visits
5. Negative FOBT at Baseline (visit 2) and visit 3 as defined in the protocol

Key Exclusion Criteria:

1. History of any major surgical procedure or clinically significant physical trauma in the last 6 months, in the opinion of the investigator, that may pose a risk to the participant by study participation
2. Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to the screening visit
3. Hospitalized for any reason within 30 days of the screening visit
4. Estimated glomerular filtrate rate (eGFR) of \<60 mL/min/1.73m2 at screening as described in the protocol.
5. Current smoker or former smoker, including e-cigarettes, who stopped smoking within 12 months prior to the screening visit
6. History of illicit drug or alcohol abuse within the last 2 years prior to the day 1 visit
7. Use of any prescription and nonprescription medications or nutritional supplements from approximately 2 weeks or 5 half-lives, as described in protocol
8. Has elective surgery planned to occur prior to end of study (EOS)

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Efficacy of the Quell Wearable Device for Chronic Low Back Pain

This is a 1-year trial designed to gather information about the use of the Quell for persons with chronic musculoskeletal low back pain.

Research Objectives: This is a 1-year trial designed to gather information about the use of the Quell for persons with chronic musculoskeletal low back pain. The investigators hypothesize that those assigned to using the device will report reduced back pain compared with those in the control condition; with those using the device also showing improvement in sleep, mood, and level of activity. The investigators hypothesize that frequency of using the Quell (increased tolerability and adherence) will be correlated with greater reduction in pain. The investigators hypothesize that the device will be safe to use and will demonstrate a reduction in healthcare utilization (reduced clinic and Emergency Department visits). Finally, based on preliminary analyses limited by few subject numbers, the investigators will investigate whether certain individuals report greater benefit from using the Quell than others and, in particular, would predict that those with more intense and longer duration of pain will demonstrate most benefit.

Eligibility Criteria:
Inclusion Criteria:

* All participants will be adults age 21 or older and diagnosed with axial musculoskeletal back pain without radiculopathy.
* Patients will be invited to participate if they own a smart phone (iPhone or Android device) and are able to download the pain app and the Quell Relief program app onto their device.
* Patients will also be included if they:

  1. have chronic pain for \> 3 months' duration
  2. average 4 or greater on a pain intensity scale of 0 to 10
  3. are able to speak and understand English.

Exclusion Criteria:

* Patients will be excluded from participation if they meet any of the following criteria:

  1. diagnosis of cancer or any other malignant disease
  2. acute osteomyelitis or acute bone disease
  3. present or past Diagnostic and Statistical Manual-V diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation
  4. pregnancy
  5. any clinically unstable systemic illness judged to interfere with treatment
  6. a pain condition requiring urgent surgery
  7. an active substance use disorder, such as cocaine or IV heroin use, (positive on the Mini International Neuropsychiatric Interview; M.I.N.I. v.5.0) that would interfere with study participation
  8. any prescription opioid use for pain
  9. have an implanted cardiac pacemaker, defibrillator, or other implanted device. All subjects will be asked to not change their treatment during the study period.
Cardiac Surgery and Postoperative Organ Dysfunction

The aim of the study is to identify the correlation between ischaemia reperfusion injury and postoperative multiorgan damage during cardiopulmonary cardiac surgery; and to investigate biomarkers that can predict postoperative organ damage in cardiac surgery.

This study proposes to observe multi-organ functional impairment of the heart, kidney and brain after extracorporeal circulation in a prospective study of clinical patients; to obtain markers with diagnostic and predictive efficacy by collecting pre and postoperative serum and heart and ear tissue samples from patients with postoperative organ functional impairment, performing combined proteomic and metabolomic analyses, and by analysing them with detailed postoperative clinical prognostic data using machine learning algorithms.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥50 years; patients requiring mitral valve replacement surgery or mitral valve plus aortic valve replacement under cardiopulmonary bypass
2. Agreed to participate in this study, and signed the informed consent form.

Exclusion Criteria:

1. History of neurological disease (stroke, reversible ischemic hypoxia, transient ischemic attack, or Neurodegeneration) ;
2. Patients with severe preoperative renal insufficiency (serum creatinine \> 442 μmol/L or need renal replacement therapy) ,
3. liver dysfunction (Child-Pugh grade C)
4. myocardial infarction within 4 weeks
5. ASA grade ≥ V
Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients

Bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), is an antiangiogenic treatment currently proposed to recurrent high grade glioma patients. Unfortunately some patients fail to respond to this treatment and finding biological factors allowing the discrimination between potential responders and non responders would be very helpful. As the immune system plays a key role in angiogenesis induction and maintenance in cancer, it could serve as a surrogate marker of angiogenesis in cancer patients.

The purpose of this study is to determine the influence of bevacizumab treatment on circulating immune cells in high grade glioma patients and to search for a link between the variation of these cells and the response to treatment.

The following leucocyte subsets will be analyzed in whole blood before treatment and before cycles 3, 5 and 7:

* Classical, intermediate, nonclassical and Tie2 expressing monocytes.
* Regulatory T cells (Treg).
* Myeloid Derived Suppressor cells (MDSCs) The variation of the absolute numbers (or relative percentages) of the cells in the blood of patients will be correlated to the response to treatment assessed according to the RANO criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proved recurrent glioblastoma or anaplasic glioma,
* Tumor recurrence documented by MRI at least 3 months after the end of radiotherapy or chemotherapy.
* Patients for whom a treatment by bevacizumab is proposed by a multidisciplinary team staff.
* Age ≥ 18.
* Signed informed consent.
* Affiliation to a social security coverage

Exclusion Criteria:

* Known Hepatitis B or C or HIV.
* Inclusion in another clinical trial.
* Patient having received an anti-angiogenic therapy.
* Pregnant or breast-feeding woman.
* Person deprived of liberty or under guardianship or trusteeship or judicial protection
* Inability to give informed consent
* Person unable or unwilling to comply with the requirements of the protocol for geographical, social or psychological reasons.