cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients

This study evaluates the safety and efficacy of 6 weeks dosing Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura Patients. All of the subjects in this study receive Hetrombopag.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

  1. Confirmed diagnosis of chronic ITP,a peripheral blood smear or bone marrow examination should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia.
  2. Patients had a platelet count of less than 30,000/µL both in the screening period and baseline.
  3. Subjects who are refractory or have relapsed after at least one prior ITP therapy.
  4. Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization.
  5. Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
  6. A complete blood count (CBC), within the reference range, with the following exceptions.
* Platelets \<30×109/L is required for inclusion .
* Hemoglobin: females and males 10.0 g/dl are eligible for inclusion.
* Absolute neutrophil count (ANC) ≥1500/µL (1.5×109/L) is required for inclusion.

  7.PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s.

  8.Female subjects have a negative result with HCG testing in the screening period and baseline.
* Exclusion Criteria:

  1. Patients with any prior history of arterial or venous thrombosis，or diagnosis as Thrombophilia.
  2. Subjects diagnosed with tumor.
  3. Have pre-existing cardiac disease within the last 3 months.No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) \>450msec or QTc \>480 for patients with a Bundle Branch Block.
  4. Female subjects who are nursing or pregnant at screening or pre-dose on baseline.
  5. Treatment with thrombopoietin or an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
  6. Treatment with Rituximab or Splenectomy within the lat 6 months.
  7. Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days or five half-lives (whichever is longer).
  8. Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for \>3 consecutive days within 2 weeks of the study start and until the end of the study.
  9. Any laboratory or clinical evidence for HIV infection.Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening.
A Registry of Tuberculosis Cases in the CPCRA

PRIMARY: To estimate the proportion of tuberculosis patients in the CPCRA who have drug-resistant tuberculosis (TB) and to describe the patterns of drug resistance.

SECONDARY: To compare drug resistance data on the Mycobacterium tuberculosis isolates of HIV-infected patients to those of HIV-uninfected patients who are being followed in the CPCRA. To assess the relationship of resistance data with geographic, demographic, and HIV and TB risk factor information.

Geographic areas and demographic subgroups affected by the TB epidemic appear to be congruent and associated with the concurrent HIV epidemic. The total number of CPCRA patients who will develop, or who have experienced, confirmed TB is unknown. It is critical to determine the depth and breadth of the current problem of drug-resistant TB.

Geographic areas and demographic subgroups affected by the TB epidemic appear to be congruent and associated with the concurrent HIV epidemic. The total number of CPCRA patients who will develop, or who have experienced, confirmed TB is unknown. It is critical to determine the depth and breadth of the current problem of drug-resistant TB.

For both retrospective and prospective components of the study, demographic, geographic, HIV and TB risk factor information will be collected on CPCRA patients with confirmed pulmonary or extrapulmonary TB. Mycobacterial culture results will be recorded. Retrospective data will be collected on CPCRA patients with confirmed tuberculosis who have been diagnosed since January 1992 until the time of site registration. Prospective data will be collected on CPCRA patients with confirmed tuberculosis diagnosed during the period of 1 to 2 years following site registration.

Eligibility Criteria:
Patients must meet the following criteria:

* CPCRA patients with confirmed pulmonary or extrapulmonary TB. Confirmed clinical TB requires a positive culture for Mycobacterium tuberculosis.

NOTE:

* There is no requirement that patients have HIV infection.
AI Prediction Model and Risk Stratification for Lung Metastasis in Colorectal Cancer

Background:

To assist clinicians with diagnosis and optimal treatment decision-making, we attempted to develop and validate an artificial intelligence prediction model for lung metastasis (LM) in colorectal cancer (CRC) patients.

Method:

The clinicopathological characteristics of 46037 CRC patients from the Surveillance, Epidemiology, and End Results (SEER) database and 2779 CRC patients from a multi-center external validation set were collected retrospectively. After feature selection by univariate and multivariate analyses, six machine learning (ML) models, including logistic regression, K-nearest neighbor, support vector machine, decision tree, random forest, and balanced random forest (BRF), were developed and validated for the LM prediction. The optimization model with best performance was compared to the clinical predictor. In addition, stratified LM patients by risk score were utilized for survival analysis.


Eligibility Criteria:
Inclusion Criteria:

* patients with pathologic confirmation of a primary CRC diagnosis

Exclusion Criteria:

* (1) patients with multiple primary cancers or other malignancies; (2) patients identified via autopsy or death certificate; and (3) patients with uncertain clinical data values
Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis

Goal is to physiologically detect unsuspected small airways obstruction in children and adults with treated heterozygous and homozygous cystic fibrosis. Unsuspected refers to normal routine pre bronchodilator spirometry including normal FEV1(L), FVC (L). and FEV1/FVC%. This is a retrospective study.

The current study is based on current investigators previously published patho-physiologic and lung CT studies in small airways intrinsic obstruction, emphysema, and asthma. Current investigators have demonstrated that despite the presence of normal routine spirometry including normal FEV1(L), FVC (L), and FEV1/FVC% that unsuspected small airways obstruction, and emphysema can be detected. This has been achieved by presence of isolated abnormal expiratory airflow limitation at low lung volumes on the maximal expiratory flow volume curves. This includes abnormal expiratory airflow at 75% and 80% expired lung volume. Current investigators believe investigators will be able to detect unsuspected small airways intrinsic obstruction, and peripheral airway bronchiectasis proven by lung CT, in patients with cystic fibrosis despite presence of pre bronchodilator normal routine spirometry.

Eligibility Criteria:
Inclusion Criteria:

Heterozygote or homozygote patients with cystic fibrosis with normal routine pre bronchodilator spirometry including normal FEV1(L), FVC(L) and FEV1/FVC%.

Exclusion Criteria:Heterozygote or homozygote patients with cystic fibrosis with ABNORMAL routine pre bronchodilator spirometry

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Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.

Sleep apnea is a common situation that affects up to 80% of acromegalic patients. This disease is linked to disturbance on the carbohydrate metabolism increasing the rates of diabetes. The objective of this trial is to assess (with the euglycemic hyperinsulinemic clamp) the impact of the treatment of sleep apnea, with a continuous positive air pressure device (CPAP), on the insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Acromegalic patients
* Moderate to severe sleep apnea
* Using somatostatin analogues at maximum dosage possible for at least 6 month

Exclusion Criteria:

* Unstable angina or high risk for stroke
* Hepatic or renal insufficiency
* Uncontrolled diabetes
* Seizures
* Steroids use
* Uncontrolled hormonal deficiencies
The Effect of Exercise on Wound Healing While Off-loading

This study seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer. Hypothesis: Consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of wounds.

The purpose of this project is to establish the effect of the addition of exercise to an off-loading intervention on the healing time for people with diabetes mellitus and a foot ulcer.

While benefits of physical activity and exercise are clear, the benefit of exercise on wound healing in individuals with diabetes has not been elucidated. It is critical to better understand how prescribed exercise effects the healing speed in patients receiving wound care with appropriate off-loading. If exercise does decrease healing time, the benefit to the patient may include lower cost, decreased risk of infection, decreased burden on a caregiver, and improved quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Have diabetes
* Have an active plantar ulceration
* With or without peripheral neuropathy
* Able to safely exercise
* Receiving care for their plantar ulceration, including off-loading

Exclusion Criteria:

- Presence of an untreated infection, osteomyelitis, or gangrene
Low Energy Therapy to Convert Ventricular Tachycardias

The LEVER study is a prospective, unblinded, non-randomized, first in human feasibility study that will assess and characterize early safety and effectiveness of low energy therapies in converting monomorphic ventricular tachycardias (MVTs).

The LEVER study is a prospective, unblinded, non-randomized, first in human feasibility study that will assess and characterize early safety and effectiveness of low energy therapies in converting monomorphic ventricular tachycardias (MVTs). Subjects must be already indicated for standard of care VT procedure during which VT is likely to be induced (such as VT testing, VT ablation, VT mapping, or VT risk stratification testing.)

The study patches will be applied to the subject's torso, and the patches will be connected to the LEVER Acute Study System. Pacing capture threshold capture may be assessed. If monomorphic VT is induced and reaches at least 170bpm (350ms/cycle), one or more of the low energy therapies will be applied under oversight of the investigator, in an attempt to treat and convert the VT.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of ventricular tachycardia indicated for ventricular testing procedures that may include VT induction, such as VT testing, VT ablation, VT mapping, or VT risk stratification testing.
* Subjects age 18 or above, or of legal age to give written informed consent specific to local laws and requirements
* Subjects who, in the opinion of the investigator, are suitable to be enrolled in a clinical study

Exclusion Criteria:

* Subjects with any comorbidities that, in the opinion of the investigator, would exclude them from standard of care VT testing
* Subjects with VT that is known to be focal in nature
* Subjects whom the investigator believes are not hemodynamically stable enough to tolerate testing
* Subjects of childbearing age who may be pregnant.
* Subjects who are unwilling or unable to provide written informed consent.
* Subjects with any implanted device that emits electrical energy where either therapy cannot be temporarily disabled, or the subject cannot tolerate temporary disabling of therapy.
Donor-Derived EBV-Specific T Cells for Life Threatening EBV-lymphoma (OLIP-EBV-TCL-01-HMR01)

Single-patient trial aiming to provide immunological consolidation following allogeneic stem cell transplantation to a young adult patient suffering from a systemic EBV-positive lymphoma of childhood.

Following a presumed primary EBV infection, a 19 year old female patient rapidly suffered systemic inflammatory response, hemophagocytosis, multi-organ failure and evidence of EBV+ T-cell lymphoma.

The patient was aggressively treated and responded to SMILE-based chemotherapy. Once complete response was ascertained by PET imaging, the patient underwent myeloablative HLA-matched unrelated allogeneic stem cell transplantation (cyclophosphamide 60mg/Kg, total body irradiation - 12Gy with anti-thymocyte globulin). The stem cell donor had a positive serology for EBV (IgG).

The patient's EBV titer was weakly positive at the time of transplantation. A decision was made to offer consolidative treatment consisting of donor-derived ex vivo expanded EBV-reactive T cells following transplantation.

A EBV-specific T-cell line was manufactured from a portion of the cryopreserved G-CSF mobilized peripheral graft after appropriate authorizations were obtained.

The patient suffered a severe episode of intestinal graft-versus-host disease early following transplantation but received a first dose of EBV-reactive T cells (20x10e6 T cells/meter square of body surface area 5 months post-transplantation

Eligibility Criteria:
Inclusion Criteria:

1. Capacity to provide informed consent
2. Age ≥ 18
3. Negative serum pregnancy test and use of effective contraception method.

Exclusion Criteria:

1. Administration within less than 28 days of T-cell depleting antibodies (ATG, OKT3, Campath)
2. Pregnancy
3. Any abnormal condition or laboratory result that is considered by the Principal Investigator capable of altering patient or study outcome.
4. Active uncontrolled GVHD (acute GVHD grade II-IV or progressive extensive chronic GVHD) at time of enrolment or infusion.
Drug-induced Kidney Injury Model

To establish the prediction model of renal dysfunction in patients with drug-induced renal injury and study the prognosis of different drug treatments


Eligibility Criteria:
Inclusion Criteria:

* Drug-induce acute kidney injury

Exclusion Criteria:

* 1.Dialysis patients; 2.No baseline creatinine; 3.Obstructive AKI; 4.Clinical data were incomplete.
24-week Study With Open Label Extension of VX-509, an Oral JAK3 Inhibitor, in Subjects Taking Methotrexate

This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor, for treatment of subjects with active RA who have had an inadequate response to Methotrexate.

VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This cascade ultimately contributes to abnormal immune response that results in chronic inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the treatment of RA, and a broad range of other autoimmune diseases.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, between 18 and 80 years of age (inclusive)
* All subjects must have been diagnosed with RA
* Must have a swollen joint count of ≥6 out of 66 joints and tender joint count of ≥6 out of 68 joints
* Baseline CRP level must be above the upper limit of normal
* All subjects must have been receiving stable MTX coadministered with folic or folinic acid (at least 5 mg/week)
* Subjects may remain on 1 nonsteroidal anti-inflammatory medication during the study (aspirin ≤ 325 mg/day is allowed).
* Subjects must not have received prior treatment with a JAK inhibitor
* Subjects who are on an additional nonbiologic DMARD (e.g., sulfasalazine) must be willing to discontinue that DMARD after signing consent, except for hydroxychloroquine
* Subjects may have received previous therapy with a single TNF inhibitor (e.g., etanercept, adalimumab, infliximab, golimumab, certolizumab pegol)
* Females must have a negative pregnancy test prior to study dosing
* Sexually active subjects and their partners must agree to contraceptive requirements

Exclusion Criteria:

* History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
* Subjects with inflammatory, rheumatological disorders other than RA
* Pregnant or nursing female subjects
* Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant
* Subjects who have planned major surgery (e.g., joint replacement) or procedures during the study
* History of drug abuse or positive drug screen
* History of alcohol abuse or excessive alcohol consumption
* History of tuberculosis (TB) infection of any kind (pulmonary or extrapulmonary, active or latent), regardless of history of anti-TB treatment.
Soft Tissue Responses Around Nanostructured Calcium-phosphate-coated Implant Abutments on Dental Implants: Histological, Genetic and Clinical Evaluation in Smokers and Non-smokers.

* Baseline:

  * Standard preparation of the osteotomy
  * Placement of 2 dental implants
  * On each implant one of both types of healing abutments is placed
  * Suturing
  * Standardized radiography to measure bone-levels at baseline
  * Digital impression of the surrounding gingiva with an intra-oral scanner (a non-invasive method) to measure the baseline level of the gingiva
* 2 weeks after Baseline:

  o Removal of the sutures
* 4 weeks after Baseline:

  * A 2nd digital impression of the soft tissue with an intra-oral scanner
  * Collecting crevicular fluid by placing paperpoints in the provided apertures in the healing abutments for 60 seconds without bleeding.
  * Measuring of the pocket depth in the provided apertures in the healing abutments with an automated probe.
  * Removal of the Healing Abutment with the attached soft tissue en-bloque.
  * Placement of a new, regular, Encode Healing Abutment.
* 10 weeks after Baseline:

  * Start of standard prosthetic procedure. In this study we expect that the soft tissue attachment (i.e. the gingival attachment) will be stronger and earlier achieved at the nano-structured healing abutments than at the normal, uncoated healing abutments. This would lead to a more stable soft tissue complex on the long rung and thus providing a more predictable aesthetic outcome. Secondly, a stronger attachment would mean a stronger barrier against micro-organisms and might influence the occurrence of peri-implantitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible for this study if they are in need of minimum 2 dental implants and have sufficient bone to place these implants

Exclusion Criteria:

* All patients with limited bone
* Periodontally compromised patients
* Patients who took antibiotics 3 months before implantation
* Patients with uncontrolled diabetes
* Pregnant patients
* Patients who received radiotherapy in the head/neck region
* Patients under chemotherapy
* Patients who had intravenous use of bisphosphonates
Cerebellar Deep Brain Stimulation or VNS for Chronic Post-stroke Motor Rehabilitation

Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. Vagus nerve stimulation was also conducted for motor function after ischaemic Stroke.We hypothesized that cerebellar stimulation was superior to vagus stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum.


Eligibility Criteria:
Inclusion Criteria:

* Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 12-36 months before surgery.
* Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42
* Sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension).

Exclusion Criteria:

* Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4)
* Severe cognitive impairment (Mini Mental State Examination \< 24)
Transcutaneous Partial Oxygen and Carbon Dioxide Pressures Compared With Blood Gas Values

Partial blood oxygen and carbon dioxide pressures obtained in critical ill neonates by transcutaneous sensors will be compared to respective values obtained by medically indicated arterial and capillary blood gas analyses. The influence of blood withdrawal method, sensor operational temperature and application time, presence of cyanotic heart malformations and/or intra or extra cardiac right to left shunt, vasoactive drugs, elevated non-conjugated bilirubin, and skin and soft tissue oedema, skin colour and perfusion conditions will be elucidated as well as sensor's safety. Study duration will be 48 hours with sensors applied and additional 4 hours of further surveillance for thermal injury.


Eligibility Criteria:
Inclusion Criteria:

* Late premature or term birth newborn infants (34 0/7 until 43 6/7 weeks gestational age (GA)).
* Age between first day of life and 43 6/7 weeks postmenstrual age.
* Ability of care taker to understand verbal and written instructions and informed consent in German.

Exclusion Criteria:

* Care taker unable or unwilling to give written informed consent in German.
* Care taker not understanding German and without a family member able to translate.
* Written informed consent cannot be obtained for any other reason.
Evaluation of the Effects of Passive Smoking and Parental Stress on Challenging Behaviors in Mentally Retarded Children With Urine Cotinine Levels

This research was planned to determine the effect of environmental cigarette smoke exposure and parenting stress level on the severity of challenging behaviors in mentally disabled children

This research was planned to determine the effect of environmental cigarette smoke exposure and parenting stress level on the severity of challenging behaviors in mentally disabled children

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-10 with mental disabilities
* Parents' ability to speak and understand Turkish
* Parents' willingness to participate in the study

Exclusion Criteria:

Children who do not match the age group and do not meet the inclusion criteria
The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy in patients with steroid resistant Autoimmune Inner Ear Disease.


Eligibility Criteria:
Inclusion Criteria:

* Autoimmune Inner Ear Disease with active deterioration in at least one ear
* Failure to respond to a trial of high-dose corticosteroid therapy
* Contraceptive measures adequate to prevent pregnancy during the study

Exclusion Criteria:

* Evidence of retrocochlear pathology (vestibular schwannoma) or inner ear malformation (Mondini Malformation or Enlarged Vestibular Aqueduct)
* History of active or chronic infections
* Currently receiving, or having received treatment for a malignancy in the past three years
* Hearing loss that coincides with significant, disabling episodes of vertigo
* History of allergic or anaphylactic reactions to monoclonal antibodies
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply