cyrilzakka/clinical-trials huggingface dataset:
Safety Study of AP24534 to Treat Chronic Myelogenous Leukemia (CML) and Other Hematological Malignancies

The purpose of this study is to determine the maximum tolerated dose or a recommended dose of oral AP24534 in a defined schedule in patients with refractory or advanced chronic myelogenous leukemia and other refractory hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female ≥ 18 years old
* Diagnosed hematologic malignancy (other than lymphoma) that has relapsed or is refractory to standard care or for which no standard care is available or acceptable
* Able to give written informed consent
* ECOG performance status ≤ 2
* BSA ≥ 1.5 m² (first cohort only)
* Minimum life expectancy of 3 months or more
* Adequate renal function defined as serum creatinine \<1.5× upper limit of normal (ULN) for institution
* Adequate hepatic function (defined as: Total bilirubin \<1.5 × ULN for institution; ALT and AST \<2.5 × ULN for institution \[\<5 X ULN if liver involvement with leukemia\]; Prothrombin time \<1.5 × ULN)
* Ability to comply with study procedures in the Investigator's opinion
* Adequate cardiac function defined as ejection fraction (EF) \>40% by any method of the investigator's choice
* Normal QTcF interval on screening ECG evaluation, defined as QTcF of \<450 ms.
* For females of childbearing potential, a negative pregnancy test must be documented prior to enrollment
* Female patients who are of childbearing potential must agree to use an effective form of contraception with their sexual partners throughout participation in this study

Exclusion Criteria:

* Have had cytotoxic chemotherapy or radiotherapy within 21 days prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 28 days earlier with the exception of alopecia
* Received any other investigational agents or have received an investigational agent within 14 days of starting ponatinib
* Malabsorption syndrome or other illness which could affect oral absorption
* Significant uncontrolled cardiac disease
* Patients taking medicinal products that are known to be associated with prolongation of the QT interval on the electrocardiogram.
* Uncontrolled hypertension (Diastolic BP \>100 mmHg; Systolic \>150 mmHg)
* Uncontrolled intercurrent illness
* Pregnant
* Known infection with HIV
* Autologous or allogeneic stem cell transplant \< 3 months prior to enrollment; any evidence of ongoing graft versus host disease (GVHD), or GVHD requiring immunosuppressive therapy
* Another primary malignancy within the past 3 years
* Any condition or illness which, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the safety of the drug
* Patients taking medicinal products that are known to be associated with prolongation of the QT interval on the electrocardiogram
* Major surgery (with the exception of intravenous catheter placement or bone marrow biopsy) within 14 days prior to initiating ponatinib therapy
OPTIMISE-CKD Study_current Clinical Landscape in Spain

OPTIMISE-CKD is a retrospective, observational study, using secondary data. The incidence of renal disease, including CKD, using eGFR or UACR laboratory measurements and diagnostic codes will be assessed in the study population. The study will also assess the incidence of selected cardiovascular and renal events and the current use of kidney-protective treatments.


Eligibility Criteria:
Inclusion Criteria:

Age ≥18 years as of study index date

* With renal function measured as either of the following:

  * At least 1 UACR measure of ≥30 mg/g; OR
  * At least 2 eGFR measures taken ≥90 days apart, of which both eGFR is ≤75 ml/min/1.73m2 ; OR
* registered with Chronic Kidney Disease (CKD) diagnosis in the medical history (without biochemical confirmation)

Exclusion Criteria:

* History of stage 5 CKD, dialysis, organ transplant, type 1 diabetes, or gestational diabetes on or before the start date of the observation period
Statistically Analysis of Carpal Tunnel Syndrome Diagnosis

Trap neuropathies; They are compression neuropathies that occur as a result of peripheral nerves being compressed for various reasons along their anatomical paths. Although each nerve has areas suitable for anatomical entrapment, compression can occur at any point along the nerve. Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy caused by compression of the median nerve at the wrist level. Its prevalence in the general population is 2.5-11%.

Although the majority of cases are idiopathic, it may also occur secondary to pathologies such as pregnancy, diabetes mellitus, thyroid dysfunction, arthritis, wrist fractures and acromegaly or occupation. The diagnosis of CTS is made clinically, but the best method for definitive diagnosis is electrophysiological examination.

Some anthropometric measurements that may be associated with CTS were made and their effect on the risk of CTS was investigated. In a study conducted by Sabry et al. in 2009, it was reported that there may be a relationship between BMI, wrist ratio (ratio of wrist depth to width) and wrist-palm ratio (ratio of wrist depth to palm length) and CTS risk. In a study by Lim et al. in 2008, it was reported that the critical value for wrist ratio was 0.70 and above. However, there were no studies reporting how many percent predictors of anthropometric measurements according to the severity of CTS.

The study was planned as a quantitative research. Socio-demographic information form, anthropometric measurements of hand grip strength, palm length, hand width length, wrist circumference length, Visual Analog Scale scale, EMG findings will be evaluated by hand dynamometer.

Trybus et al. Considering the study they conducted in patients with CTS in which they examined hand anthropometric measurements in CTS, it was planned to include 100 patients in the study with a power range of 80% and an effect width of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to outpatient clinics with symptoms of CTS
* Findings of CTS in physical examination
* CTS diagnosis was confirmed by nerve conduction study
* KTS grade mild or moderate
* He has not received physical therapy for this reason in the previous 1 year
* No steroid injection and no treatment for neuropathic pain (pregabalin, gabapentin, etc.)

Exclusion Criteria:

* - Those under the age of 18 Those with a history of previous surgery or fracture of the affected hand and wrist Those with diabetes mellitus, chronic kidney failure, gout, rheumatoid arthritis, thyroid diseases
* Pregnant Those with polyneuropathy, radiculopathy, plexopathy, thoracic outlet syndrome
Differential Clinical and Serologic Response in Psoriasis and Psoriatic Arthritis to Drug Treatment

Psoriasis is a multifactorial cutaneous disorders which affects about 100000 patients in Taiwan. Psoriatic arthritis is also present in about 20\~30 percents. Many drugs have been shown to aggravate psoriasis including drugs used in the treatment of psoriatic arthritis. On the contrary, anti-psoriatic drugs are also known to aggravate or induce psoriatic arthritis. Psoriasis and psoriatic arthritis are believed to share the same pathogenic lymphocytes, but the differential responses to drugs are intriguing. This also causes problems in the treatment of psoriasis and psoriatic arthritis. Recently different serologic markers have been found for the assessment of psoriasis and psoriatic arthritis. Recent genetic study showed a different genetic susceptibility genes. We tested the serologic responses of three new biologic drugs used in the treatment of psoriasis and psoriatic arthritis. Paired blood samples of the same patients before and after 12 weeks of treatment were used. IL6 decreased after alefacept and etanercept but was increased after efalizumab treatment without statistical significance (Paired t test: 0.3336、0.2773、0.5904)。IL-8 decreased after etanercept but increased after efalizumab and alefacept without statistical significance (Paired t test: 0.4031、0.6749、0.2998)。IL10 decreased after efalizumab and etanercept, but increased significantly after alefacept treatment (Paired t test: 0.7254、0.5123、0.0350)。None of the treatment has a significant effect on TNF-alpha. HC10 decreased after alefacept and efalizumab,but increased after etanercept treatmentwithout statistical significance (Paired t test: 0.6589、0.1576、0.1988).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of psoriasis
Effectiveness of an Epilepsy Application for Self-management in Viet Nam

Epilepsy is a common neurological disease which effects all genders, ages and geographic regions. Self-management refers to "the ability of the individual, in conjunction with family, community, and healthcare professionals, to manage symptoms, treatments, lifestyle changes, and psychosocial, cultural, and spiritual consequences of health conditions". Optimal self-management may improve self-efficacy, knowledge about epilepsy of people with epilepsy (PWE) and family, medical compliance and avoidance of seizure triggers. This study aims to determine the effectiveness of the epilepsy app for PWE to improve self-management

Epilepsy which affects over 70 million people worldwide, is one of the most common neurological diseases. Epilepsy is "a disease characterized by an enduring predisposition to generate epileptic seizures and by the neurobiological, cognitive, psychological, and social consequences of this condition." Therefore, self-management plays a crucial role for people with epilepsy (PWE) to adapt their lifestyles and behaviors for those long-lasting changes. Self-management is a dynamic, interactive, and daily process in which individuals engage to manage a chronic illness. Self-management is "the ability of the individual, in conjunction with family, community, and healthcare professionals, to manage symptoms, treatments, lifestyle changes, and psychosocial, cultural, and spiritual consequences of health conditions." Optimal self-management may improve self-efficacy, knowledge about epilepsy of PWE and family, medical compliance, and avoidance of seizure triggers.

Mobile health (mHealth) epilepsy application (apps) refers to any digital software (e.g., via the Internet, mobile device, wearable, or desktop platforms) capable of collecting, tracking, or sharing data while interacting with patients about their epilepsy health information. Recent studies have reported that mHealth applications improved the management of people with chronic illnesses, including epilepsy. In the digital era, smartphones are becoming more and more popular worldwide. In 2016, there were 24.8 million (30% of the population) smartphone users in Viet Nam, and this share is predicted to rise by 40 percent by 2021. Nanacara is an educational app for PWE to improve self-management.

A systematic review showed 20 English apps designed to improve self-management for PWE. Only one randomized clinical trial (RCT) study showed the effectiveness of mobile apps in increasing self-management for PWE. This result implied the lack of validation study related to the clinical use of the epilepsy apps. This study aims to determine the effectiveness of the epilepsy app for PWE to improve self-management.

Eligibility Criteria:
Inclusion Criteria:

* People with epilepsy diagnosed and treated by neurologists
* Smartphone users

Exclusion Criteria:

* Substance dependence
* Suicidality
* Limited language proficiency
Root Resorption Accompanied Clear Aligners and Fixed Orthodontic Appliance

The aim of the study is to compare apical root resorption accompanied orthodontic treatment using clear aligners vs fixed appliances.

by using pretreatment and posttreatment CBCT, root resorption will be measured using a 3D imaging software.

Eligibility Criteria:
Inclusion Criteria:

* Healthy systemic condition/no systemic illness, as reported by patients.
* No use any form of anti - inflammatory drugs the at beginning of study.
* Good oral hygiene.
* Cooperative and motivated.
* In the permanent dentition with all teeth present ( except third molars).
* Minimum to moderate anterior crowding.
* No previous orthodontic treatment.

Exclusion Criteria:

* Previous upper removable orthodontic treatment.
* Patients who required surgery to correct skeletal discrepancies.
* Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).
* Uncooperative patients.
* Patients with poor oral hygiene.
Infusion of Specially Treated Umbilical Cord Stem Cells After Chemoradiation Treatment for Blood Cancers

This study hopes to show that specially treated umbilical cord cells, called stem cells, can be safely given to a person after they receive chemoradiation therapy or chemotherapy for their illness. During chemoradiation therapy or chemotherapy, a person loses all of the cells that are needed to make the different types of cells in their blood, including their immune system cells. These cells must be replaced in order for the blood and immune systems to work properly. Some people receive bone marrow transplants or other types of stem cell transplants to get the cells they need. CB001 is being developed as an option for people who need bone marrow transplants or other types of transplants to replace those cells. It is also being developed for people who do not have the option of other types of transplants.


Eligibility Criteria:
Inclusion Criteria:

* Do not have identical or 5/6 related matched bone marrow, peripheral blood or umbilical cord
* Stable disease and lack of unrelated donor
* Acute myeloid leukemia (AML) in 2nd or subsequent complete remission or first remission with high risk features
* ALL in 2nd or subsequent remission or first remission with high risk features
* Myelodysplastic syndrome (MDS)
* Non-Hodgkin Lymphoma (NHL)
* Chronic Myelogenous Leukemia (CML)
* Adequate function of heart, liver, kidneys and lungs

Exclusion Criteria:

* Females who are pregnant
* Poor ability to perform daily activities
* Weight under 40 kilograms (88 pounds)
* AML caused by chemoradiation
* Prior stem cell transplant
* Uncontrolled infection at time of transplant
* Active fungal infection
* HIV infection
* Primary myelofibrosis
* Receiving other research drugs
* Unable to provide informed consent
Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia

Primary objective: To examine whether the switch to paliperidone ER from risperidone improves cognitive function in stabilized patients with schizophrenia.

Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after switching to paliperidone ER from risperidone

This is a 12-week, randomized, parallel-group, open labeled, flexible-dose study. The patients will be randomized to the risperidone-continuation group in which they continue to receive risperidone, or to the paliperidone-switch group in which they are switched from risperidone to paliperidone. In the paliperidone-switch group, risperidone will be tapered off during the first 4 weeks of the study, while paliperidone is titrated simultaneously. The doses of both drugs will be adjusted according to the clinical judgment of each research psychiatrist, within 6 mg/day of risperidone and 12 mg/day of paliperidone.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as schizophrenia by DSM-IV-TR criteria both in inpatients
* Patients who are symptomatically stable, as judged by the treating psychiatrist, and receive a stable dose of risperidone for a minimum of 2 weeks before enrollment.
* Patients with ability to complete various questionnaires.
* Patients and/or their legal guardians/representatives who sufficiently understand the objective of the study and sign informed consent form

Exclusion Criteria:

* Active psychotic symptoms, including severe behavioral disturbance
* Relevant history of or current presence of any significant or unstable medical disease
* A woman who is pregnant, breast-feeding or planning to become pregnant during the study period
* Patients with the history of serious allergy or multiple adverse drug reactions
* Patients with the history of taking paliperidone ER within 60 days
* Patients with history of taking clozapine within 60 days
* Patients who require the treatment of other medications influencing CNS, except permitted concomitant drugs in advance
Application of Genomic Techniques and Image Processing Using Artificial Intelligence to Obtain a Predictor Model Risk of Melanoma

The aim of this study is to develop a predictive model of risk of developing melanoma. The investigators will used artificial intelligence techniques to analysed images patterns obtained by clinical and dermoscopic pictures. The investigators want to defined a new predictive risk model obtained from genetic information and image analysis of pigmented lesions. This model could help to discriminate more accurately those patients who are most likely to develop melanoma in a high-risk population.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age;
* Followed up patients in the Pigmented Lesions Unit at Reina Sofia University Hospital with high risk of developing melanoma (First-degree family/personal history of familiar melanoma and/or melanocyticnevi above 50 and/or dysplastic or atypical nevi);
* All nevi for which there is at least one dermatoscopy registry will be included.

Exclusion Criteria:

* not enough data in the patient clinical history;
* located lesions on the face, scalp, mucous membrane or on acral área;
* nodular or metastatic melanoma diagnosis
* type V or VI of Fitzpatrick phototyping scale
Dry Needlig Vesus Tecartherapy in Low-back Pain Treatment

Introduction: Diathermy is a new tool that could help subjects with chronic low back pain (CLBP), with no studies having compared it to other interventions already investigated such as dry needling.

Hypothesis: Diathermy is more effective than dry needling in improving pain intensity in the short term in subjects with CLBP.

Design: randomised controlled trial Methods: We will conduct a convenience sampling, with subjects receiving 2 treatment sessions with diathermy or dry needling, according to allocation. Subjects will be assessed at baseline, 1 week, 1 month and 3 months after treatment for pain intensity, disability, kinesiophobia and catastrophizing. Analysis of variance (ANOVA) and moderation analysis will be performed to evaluate the results, with 95% confidence intervals (CI).

A prospective longitudinal experimental randomised controlled trial study will be conducted from August 2022 to March 2023. The study will be conducted in accordance with the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement,15 and in accordance with the Declaration of Helsinki.

Subjects were randomly assigned to one of the two intervention groups:

Diathermy. Diathermy treatment was applied using the TCaRe Power diathermy instrument (PRIM Physio©), using a capacitive system with an intensity of 50%, with slight variation depending on patient tolerance and 500khz. The therapy will be applied for 10 minutes on each side of the patient's lumbar region, who will be positioned in prone decubitus during the intervention.

The application will be active along with massage techniques. Dry needling. Dry needling is performed with a 4cm needle (APS Dry Needles®) on the most symptomatic side of the patient on palpation. To perform the technique, the patient is positioned in prone position on the couch. The physiotherapist palpates the lateral border of the lumbar iliocostalis muscle and performs the tapping technique in a latero-medial direction parallel to the stretcher.

The technique is performed by applying 12 incisions. After the application of the technique, ischaemic compression shall be performed for 1 minute.

Patients will complete a home exercise program

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* Chronic non-specific low back pain.
* Duration of pain of more than 6 weeks.

Exclusion Criteria:

* Neurological signs or symptoms.
* Radicular pain.
* Radiating pain below the knee.
* Belonephobia.
* Traumatic processes and/or surgeries in the lumbar region in the last year.
* Having received physiotherapy treatment in the last 3 months.
* Systemic diseases such as cancer, rheumatic diseases, neurological diseases.
The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and Subclinical PTSD Among Adolescents : a Pilot Study

The study aims to examine the effectiveness of the group-delivered guided written exposure therapy (G-WET) for post-traumatic stress disorder (PTSD) and subclinical PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 40 participants, with 20 randomized to the G-WET group and 20 randomized to the waiting list (WL) group. The G-WET intervention consists of 5-8 group sessions. The primary outcome PCL-5 ( PTSD Checklist-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up assessments.


Eligibility Criteria:
Inclusion Criteria:

1. Adolescents aged 10-18 years.
2. Meeting full or subthreshold PTSD (up to one symptom missing) diagnostic criteria according to the Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I).
3. If taking psychotropic medication, currently stabilized on psychotropic medication for at least four weeks.
4. Capable of writing and understanding written instructions.

Exclusion Criteria:

1. Presence of severe psychopathology necessitating immediate medical attention
2. Moderate to high suicide risk (e.g., intent or plan to attempt suicide in the near future)
3. Evidence of a moderate or severe traumatic brain injury
4. Currently undergoing psychotherapy specifically for PTSD.
Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency

To evaluate long-term safety of growth hormone replacement in adult patients with growth hormone deficiency


Eligibility Criteria:
Inclusion Criteria:

* Having completed the preceding long-term study of growth hormone replacement in adult patients diagnosed with growth hormone deficiency.
* Other pituitary hormone deficiencies being replaced if appropriate

Exclusion Criteria:

* With severe impairments of cardiac, pulmonary, renal or hepatic functions
* With severe psychological disorders
* With malignant cancer
* With hypertension uncontrolled
* With diabetes mellitus
Needle Radiofrequency Treatment for Submental Fat

The investigators aimed to evaluate the efficacy and safety of a fractional radiofrequency device with a micro-insulated needle to reduce submental fat.


Eligibility Criteria:
Inclusion Criteria:

* Patients with excess submental fat on a grade of 1\~4, as assessed by the Physician-Assisted Submental Fat Rating Scale

Exclusion Criteria:

* mental impairment, infectious disease
* history of keloid development
* pregnancy, pacemaker
* use of anticoagulants
* undergoing a facelift procedure within the prior 6 months.
Register of Autoimmune Bullous Dermatoses

Autoimmune bullous dermatoses are a group of diseases with chronic course. They are provoked by the production of autoantibodies against the dermal-epidermal junction or against the inter-keratinocyte junctions, resulting in the formation of intra-epidermal or sub-epidermal blisters.

The diagnosis of autoimmune bullous dermatoses is based on clinical and immunopathological findings, including skin direct immunofluorescence.

Systemic corticosteroid therapy is generally considered as the mainstay of treatment for many years both for bullous pemphigoid and pemphigus which are the most frequent diseases.

The aim of the study is the creation of a register of patients suffering from autoimmune bullous dermatoses to quickly identify patients who can be included in clinical trials or retrospective epidemiological studies

Eligibility Criteria:
Inclusion Criteria:

* patients with autoimmune bullous dermatosis
* patients cared for in dermatology referral center of Reims, Rouen or Limoges
* patient consenting to participate to the study

Exclusion Criteria:

- patient \<18 years