cyrilzakka/clinical-trials huggingface dataset:
Study of Effectiveness and Safety of Extracorporeal Shock Wave Therapy (ESWT) for Treatment of Painful Heel Syndrome

The purpose of this study is to determine if the Storz Duolith SD1 is more effective than placebo for treatment of heel pain syndrome for patients who have failed conservative treatment with other therapies.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* ability of subject or legal respondent to give written informed consent
* signed informed consent
* diagnosis of painful heel syndrome
* 6 months of unsuccessful conservative treatment
* washout from conservative treatment
* scores of 5 or greater on three VAS scales
* score of 3 or 4 on Roles and Maudsley Scale
* willingness to refrain from specified concomitant therapies
* willingness to keep subject diaries
* negative urine pregnancy test (if applicable) required use of contraception (if applicable)

Exclusion Criteria:

* tendon rupture, neurological or vascular insufficiencies
* inflammation of lower and upper ankle
* history of rheumatic disease, collagen, or metabolic disorders
* history of hyperthyroidism
* active malignant disease with or without metastasis
* Paget disease or calcaneal fat pad atrophy
* osteomyelitis
* fracture of calcaneus
* immunosuppressive therapy
* long term (6 months or greater) treatment with corticosteroid
* insulin dependent diabetes, severe cardiac or respiratory disease
* coagulation disorder or therapy with anticoagulants or antiplatelet drugs
* bilateral painful heel
* planned treatment within 8 weeks of enrollment that may confound pain results
* less than required washout of other treatments
* previous surgery for painful heel
* previous unsuccessful treatment for painful heel with shock wave device
* history of allergy or hypersensitivity to local anesthetics
* significant abnormalities of hepatic function
* poor physical condition
* pregnant female
* active infection or history of chronic infection in treatment area
* history of peripheral neuropathy
* history of systemic inflammatory disease
* history of worker's compensation or litigation
* participation in study of investigational device within 30 days of selection or current active study participation
* in the opinion of the investigator, inappropriate for study inclusion
* unwilling to comply with study requirements
* implanted pacemaker, insulin pump, defibrillator, or neurostimulator
* implanted prosthetic device in area of treatment
* open wounds or skin rashes
Effectiveness of Transcranial Magnetic Stimulation Treatment in Patients Diagnosed With Postpolio Syndrome: A Randomized Controlled Double-Blind Study

The study is planned to include a minimum of 26 patients with paralytic poliomyelitis who meet the PPS diagnostic criteria (1). Patients will be randomized into two groups, and one group will receive only the exercise therapy used in standard treatment, while the other group will receive Transcranial Magnetic Stimulation (TMS) therapy in addition to exercise. TMS will be applied to the study group 5 times a week for 2 weeks, for a total of 10 sessions. The protocol to be applied during the study will be set to 1 Hz, and each session will last 15 minutes. All participants will be evaluated with muscle strength (manual muscle testing), 6-minute walking test, polio-related problems inventory, VAS pain, VAS fatigue, fatigue severity scale, Beck Depression Inventory, Nottingham health profile scales before, at the end of treatment, and at the end of the 3rd month. As a result of the evaluation, the potential positive effects of TMS on patients with PPS will be measured and evidence-based data for the use of this treatment modality in patients with PPS will be obtained. This study will be the first to evaluate the effectiveness of TMS in a controlled manner in a patient group with PPS. As a result of the evaluation, the potential positive effects of TMS on patients with PPS will be measured and evidence-based data will be obtained for the use of this treatment modality in patients with PPS.


Eligibility Criteria:
Inclusion Criteria:-Having been diagnosed with PPS (postpolio syndrome) -Having not received TMS treatment before

-

Exclusion Criteria:-History of epilepsy

* Presence of another disease that may be associated with the symptoms
* Inability to ambulate independently
* Presence of a neurological, psychiatric or vision-related problem that may prevent the patient from answering the questionnaires
* Presence of ferromagnetic material implanted in the body
* Organic brain pathology (vascular, traumatic, tumoral, etc.)
* History of use of drugs that lower the seizure threshold (if not receiving antiepileptic treatment)
* Severe or recent heart disease
* Alcoholism
* Pregnancy
Outcome of Three Controlled Ovarian Hyperstimulation Protocols in Poor Responding Infertility Patients

There are different controlled ovarian hyperstimulation protocols utilized in infertility patients. In this study, our aim is to specifically compare three protocols in poor responding infertility patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011).
* Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:

  * advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;
  * a poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or
  * an abnormal ovarian reserve test (antral follicle count, \<7 follicles or anti-Mullerian hormone, \<1.1 ng/ml).
Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation

Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses induce a shift to the right visual field for improving symptoms in short term.

Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency resulting from stroke with encouraging results. The hypothesis of the study is to evaluate the usefulness of brain stimulation as an adjunctive intervention to optimize and increase the rehabilitation of unilateral neglect to long-term.

Thus, the main objective is to evaluate the effectiveness of standard treatment with prismatic adaptation with anodal tDCS or sham tDCS.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* All subjects must be between the ages of 18-80
* Patient with unilateral negligence consecutive to a right hemispheric stroke
* Hospitalized in the Department of Physical Medicine and Rehabilitation (day or week) or external monitoring
* Ischemic or hemorrhagic stroke with right hemispheric topography - evidenced by a radiological report
* Diagnosis of negligence evidenced by Behavioural Inattention Test (BIT) : score ≤ 129
* Stroke \>1 month prior to study enrollment

Exclusion Criteria:

* Degenerative neurological complaint
* Uncontrolled epilepsy
* Temporo-spatial disorientation
* Language disorders or psychiatric disorders preventing understanding instructions
* History of prior stroke, multiple stroke
* Medical condition not stabilized
* Pregnancy
* Implanted material (pacemaker, defibrillator, cochlear implant, surgical clips, metal object)
* Intra-cranial material
* Unweaned alcoholism
Human Upper Extremity Allotransplantation: F/U Protocol

Upper extremity allotransplantation is a new procedure which is becoming more common in the United States. Ongoing data collection for research purposes is vital to the long-term assessment as to the safety of the procedure and accompanying immunosuppression protocol, as well as quantifying patient outcomes and changes in quality of life. For these reasons, The Johns Hopkins Hand/Arm Transplantation Team is interested in enrolling transplanted patients in a follow-up protocol to continue collecting informative data to further the field of vascularized composite allotransplantation.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 5 or more years post-unilateral or bilateral upper limb transplantation.
* Completes the protocol informed consent form.
* Consents to sample collection and storage (biopsies).
* USA citizen or equivalent.
* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.

Exclusion Criteria:

* Candidate has not received an upper extremity allotransplant.
* Any reason the study team thinks would cause the participant to be noncompliant or would put the patient at unacceptable risk if enrolled.
Repetitive Transcranial Magnetic Stimulation for First-episode Schizophrenia Patients

The aim of the study is to evaluate the effects of repetitive transcranial magnetic stimulation(rTMS)in the first-episode Schizophrenic patients: the clinical and MRI findings


Eligibility Criteria:
Inclusion Criteria:

* Age between 16-45 years
* Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist)
* PANSS\>=60
* First episode, and the patients haven't use any antipsychotic drugs

Exclusion Criteria:

* Suicide risk
* Diagnose of substance abuse/dependance
* Severe uncontrolled organic disease that may interfere in the patient´s participation in the study
* Contraindication to TMS:

  1. Implanted pacemaker
  2. Medication pump
  3. Vagal stimulator
  4. Deep brain stimulator
  5. Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding
  6. Signs of increased intracranial pressure
* Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
* Estimated IQ less than 80
* Have a sibling or parent with epilepsy
A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects

The study was designed to assess the steady-state pharmacokinetic profile of paroxetine after 14 day repeated daily dosing of the controlled release tablet formulation (25 mg) in healthy Chinese subjects.


Eligibility Criteria:
Inclusion criteria:

* 19-45 years healthy Chinese subjects
* Body weight \> 50 kg
* BMI between 19-25
* serological negative for HIV, syphilis and hepatitis B and C
* no abnormalities in ECG
* Female with negative pregnancy and male has no plan to have a child during and 3 months after the study.

Exclusion criteria:

* History of chronic physical/mental disease, current disease and concomitant medication
Effects of Low Versus High Frequency Percutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients.

Comparison between high and low frequency percutaneous electrical nerve stimulation as treatment of myofascial chronic neck pain. The main hypothesis is that low frequency treatment will have more hypoalgesic effects than high frequency, and low frequency effects will last longer.


Eligibility Criteria:
Inclusion Criteria:

* Neck pain of more than 6 months of evolution.
* Pain level of more than 30 millimeter on the VAS scale.
* Active myofascial frigger points on upper trapezius muscle.

Exclusion Criteria:

* Upper limb radiculopathy.
* Recent whiplash.
* Cervicogenic dizziness.
* Migraine.
* Previous cervical surgery.
Assessment of Hypoxia Before Radioembolization Treatment With 18F-FMISO PET

Hypoxia is a known factor for resistance to radiotherapy in tumors. Response to transarterial radioembolization is known to be variable between different patients even if the same dose of radiation was delivered. In this study the investigators aim to quantify the hypoxia in the primary and secondary tumors of liver with 18F-FMISO PET before radioembolization and to prove any effect of the hypoxia, if present, on the dose that should be delivered to tumor to ensure treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with colorectal carcinoma with liver metastasis or hepatocellular carcinoma.
* Is not eligible for surgery
* Above 18 years old
* The patients who are referred for transarterial radioembolization treatment to Ankara University School of Medicine Department of Nuclear Medicine.

Exclusion Criteria:

* Patients with ECOG performance score \>1
* Claustrophobia
* Life expectancy shorter than 3 months
* Pregnant or breast-feeding patients
The Effect of Vitamin A on Atherosclerosis

The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for 4 months on gene expression of T CD4+ lymphocyte in atherosclerotic patients(documented with angiography).

Atherosclerosis, the leading cause of death and disability in the world, is considered an inflammatory disease with a complex etiology. The immune system has a prominent role in the formation, development and destabilization of atherosclerotic plaques. A whole range of identified cytokines have been shown to play a part in atherogenesis, some with proatherogenic properties while others having antiatherogenic properties. With increasing evidence for the significant role of inflammation and the cytokines involved together with the Th1/Th2 imbalance in atherosclerosis and its progression to Coronary artery diseases (CADs), the control of cytokine production may become potential therapeutic targets and modulation of the Th1/Th2 balance may provide a new pharmacological tool to treat this disease. Vitamin A (VA) or VA-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. high level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid inhibits IL 12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or retinoic acid (RA) decreases IFNγ and increases IL5, IL10, and IL4 production. Thus, vitamin A deficiency biases the immune response in a Th1 direction, whereas high level dietary vitamin A may bias the response in a Th2 direction.

Eligibility Criteria:
Inclusion Criteria:

• The criteria for enrollment of the patients and control subjects is consecutive patients of both sexes referred to the Division of Cardiology of the one of the Hospitals of Tehran University of Medical Sciences for coronary angiography for investigation of chest pain and/or suspected CAD.

Exclusion Criteria:

* Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
* Patients who have allergy to vitamin A compounds, OR
* Patients who have used vitamin supplements in last 3 months.
Brief Bactericidal Activity of Anti-Tuberculosis Drugs

The investigators will determine the bactericidal activity of high-dose isoniazid against M. tuberculosis isolates that are (1) susceptible to isoniazid at 2.0 mcg/ml but resistant at 0.1 and 0.4 mcg/ml or (2) susceptible at 0.4 mcg/ml but resistant at 0.1 mcg/ml when tested in the BD MGIT 960 system. Further, the investigators will investigate the molecular genetic determinants of these differences in susceptibility.

To achieve these objectives the investigators will carry out an innovative variation on early bactericidal activity (EBA) study methodology. Patients at risk for drug-resistant TB will be screened for INH resistance using approved molecular assays. In those with INH-resistant TB, the investigators will quickly perform phenotypic DSTs using the direct method in the Bactec Mycobacterium Growth Indicator Tube (MGIT) 960 system, so results will be available within 7 days. If the DST results show the susceptibility patterns noted above, patients will receive 900 mg/d INH (600 mg if \<45kg), and assess its effect with serial quantitative sputum cultures for 6 days. If the concentration of viable bacteria decreases significantly, the investigators will interpret this to mean the drug is having an effect. If not, the drug is ineffective. After 6 days, the patients will resume treatment according to national guidelines.

In case the investigators identify drugs that are effective under these conditions, the investigators will sequence known and putative genes associated with the action of these drugs for the mycobacterial isolates from these patients.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* INH resistance by approved molecular genetic test
* Phenotypic drug susceptibility test results match one of the required patterns
* Sputum microscopy positive for acid fast bacilli

Exclusion Criteria:

* Ineligible for MDR TB treatment according to national guidelines
* HIV infection with CD4 count less than 50
* Pregnancy
* Incarceration
* Too sick to participate (Karnofsky score \<60, arterial pO2\<90, respiratory rate repeatedly \>25/min, clinician's judgment)
* Hepatic enzymes \>3x normal
* Estimated glomerular filtration rate \<60 mL/min/1.73 m2
* Unable to provide adequate sputum specimen
Pneumococcal Conjugate Vaccine (PCV) in HIV- Infected Children

The purpose of this study is to evaluate the immunogenicity and safety of 7 - valent pneumococcal conjugated vaccine in HIV - infected children, and assess the predictive factors for protective antibody responses after receiving the vaccine.

S. pneumoniae is an important cause of severe invasive bacterial disease in human immunodeficiency disease (HIV) infected children. The incidence of pneumococcal bacteremia cases requiring hospitalization among Thai children aged \< 5 years had a range of 10.6-28.9 cases per 100,000 persons.\[1\]

Children infected with HIV have a markedly increased risk for pneumococcal infection compared with those who are not HIV-infected. HIV-infected children had rates of invasive pneumococcal disease (IPD) that were 2.8 and 12.6 times the rate among HIV-negative children aged \<5 and \<3 years, respectively. Incidence of IPD is 6.1 cases/100 patient-years among HIV-infected children through age 7 years \[2\]

Recent important strategy in prevention of invasive pneumococcal disease (IPD) is an implementation of pneumococcal conjugate vaccine (PCV), which can induce immunity starting from 2 months of age. In a small study of 5-valent PCV among children \< 2 years of age, serotype-specific IgG antibodies (ELISA) response after 3 doses was found to be immunogenic among both groups.\[3\] The Pediatric AIDS Clinical Trials Group Study 292 show that the immunologic responses to 7- valent PCV were similar for all serotypes among asymptomatic and symptomatic HIV - infected children.\[4\] The study of quantitative and qualitative antibody responses to 9 - valent PCV in HIV-infected children in South Africa shows similar quantitative antibody responses but poorer qualitative antibody responses to the pneumococcal conjugate vaccine when compared to HIV-negative children.\[5\].

In Thailand, 7 - valent PCV (Prevnar® ) was available in 2003. It is recommended for young children and highly recommended for high risk children such as HIV-infected children, congenital heart disease or premature infants. However, one of the major obstacles for large scale implementation is cost issue. There is no previous study about immunogenicity, safety or efficacy of 7 - valent PCV in HIV -infected Thai children, the objective of this study is to assess the safety and immunogenicity of a 7 - valent PCV vaccine among HIV - infected compared with HIV - exposed children.

Eligibility Criteria:
Inclusion Criteria:

1. HIV - infected children

   * HIV infected individuals
   * Age between 2 months to 9 years
   * Signed written informed consent
2. HIV - exposed negative children

   * Maternal HIV infection, documented prior to delivery.
   * Age between 2 months to 9 years
   * Signed written informed consent

Exclusion Criteria:

* Active opportunistic infection
* History of hypersensitivity to pneumococcal conjugate vaccine or diphtheria toxoid
* Using oral steroid or immunosuppressive drugs
* Received pneumococcal conjugate vaccine, or pnuemococal polysaccharide vaccine
Lung EpiCheck Biomarkers Development Study

This study is part of the development of a non-invasive lung cancer screening test which aim to identify early-stage lung cancer in patients at high risk for lung cancer.

This is a prospective, multi-center, observational nonsignificant risk study aimed to collect blood and clinical data from primary lung cancer and control subjects to characterize various biomarkers that will discriminate between lung cancer and control subjects.

Eligibility Criteria:
Inclusion Criteria - Cases:

* Age 50-80 years
* Subjects who are currently smoking or former smokers, with at least 20 pack-years
* Subjects with either A high suspicion for lung cancer, with planned biopsy or surgery to establish a definitive diagnosis within 60 days after enrollment or treatment naive lung cancer patients confirmed by pathology.

Exclusion Criteria - Cases

* Known diagnosis or treatment of cancer from any kind in the past 5 years, except of fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix and except from the current lung cancer

Inclusion Criteria - USPSTF risk

* Age 50-80 years
* Subjects who are currently smoking or former smokers, with at least 20 pack-years

Exclusion Criteria - USPSTF risk

- Known diagnosis or treatment of cancer of any kind in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix

Inclusion Criteria - Healthy controls

* Age 20-80 years
* Never smoker or current / previous smoker \< 20 pack year history

Exclusion Criteria - Healthy Controls

* Known diagnosis or treatment of cancer of any kind in the past (lifetime), except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix.
* Not previously diagnosed with a lung lesion highly suspicious for cancer
* Under follow up or work up for any lesion suspicious for any type of cancer
* Presenting with fever with body temperature 100.4°F (38°C) or higher
* Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw
* Pregnancy
* Any history of blood product transfusion within 30 days prior to blood draw
UMP Lifestyle Medicine Program

To systematically follow patients seen at the University of Minnesota's Lifestyle Medicine Program for Weight Management.


Eligibility Criteria:
Inclusion Criteria:

* All patients seen who sign medical release form

Exclusion Criteria:

None