cyrilzakka/clinical-trials huggingface dataset:
A Randomized Controlled HD-tDCS Trial: Effects on Tinnitus Severity and Cognition

This randomized, placebo-controlled study will compare the effects of HD-tDCS (a non-invasive neuromodulation technique) with a sham stimulation. In the sham situation, patients will undergo an identical treatment but no stimulation will be applied, allowing to control for placebo effects. This study will assess the effects of HD-tDCS on chronic, non-pulsatile tinnitus in a reliable way, as confounding factors such as anxiety, depression, hearing impairment, tinnitus gradation, age, and sex will be controlled for. Ultimately, this study will result in final recommendations for a standardised protocol for the use of HD-tDCS in tinnitus patients. When accurate, individualised, and effective therapy is available for the patient, the total cost (both economical and personal) will decrease significantly. The investigation's findings will be relevant for all caretakers dealing with tinnitus patients (psychologists, psychiatrists, manual therapists, general practitioners, ENT specialists, audiologists, etc.).


Eligibility Criteria:
Inclusion Criteria:

* Duration of tinnitus: \> 6 months
* 24 \< TFI score \< 90
* HADS depression subscale \< 12
* HADS anxiety subscale \< 12
* Hyperacusis questionnaire \< 40
* Dutch- or Flemish-speaking

Exclusion Criteria:

* Somatic tinnitus
* Pregnancy
* Active middle ear pathology
* Hearing implants
* Known tumors in the head/neck region
* Patients having already had any other tinnitus treatment within the last 2 months
Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate.

The investigators analyzed a group of infertile women treated with Ulipristal Acetate (UA) for uterine fibroids at the Humanitas Fertility Center. All the patients' data were extracted from the Fertility Center external-audit-anonymized electronic research query system.

In the recent years several large studies have been published on the efficacy of Ulipristal Acetate treatment of moderate to severe symptoms of uterine fibroids in adult women: initially proposed only as pre-surgical treatment, the UA was subsequently also used for the long-term treatment of uterine myomas symptoms.

However, few data are available on the effects of UA in terms of increasing fecundability, implantation and pregnancy outcome and safety in the general population, and in infertile patients in particular.

This retrospective study aims at describing the correlation between the use of Ulipristal Acetate and pregnancy outcome in infertile patients and at comparing the UA plus surgery approach to the UA-only treatment in terms of pregnancy outcome.

Eligibility Criteria:
Inclusion Criteria:

* infertile women received at least 1 month of therapy with UA 5 mg/day for uterine fibroids
* more of 1 year of active pregnancy seeking

Exclusion:

* menopausal women;
Stroke Registration of Young Adults in China

This is a multi-center, prospective,continuous registry study. The investigators will include 3000 young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke in China. The main purpose of this study is to build the study cohort of young ischemic stroke patients in China, and to compare the prognosis and stroke recurrence of young patients with different ischemic stroke subtypes. Secondary objectives are trying to find biomarkers of stroke recurrence.

Approximately 10%-14% of all ischemic strokes occur in young adults ages 18 to 45 years old. Stroke etiology in this population differs by geographic region and has greater heterogeneity than in older individuals. Ascertain the definite etiologic classification in this young patients might be the key point to prevent the stroke recurrence and reduce the stroke burden. Advances in stroke diagnostic tests, particularly neuroimaging, refinement in classification schema. In this multi-center registry study conducted in China, we determine to explore the difference of prognosis and stroke recurrence of young patients with different ischemic stroke subtypes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 through 45 years, both genders
* First-ever acute ischemic stroke
* Onset of symptoms within 72 hours of inclusion
* Willing to participate in follow-up visits

Exclusion Criteria:

* Silent stroke
* Failure to give their informed consent
PUER ("Previously Unrecognized Emerging Risks") Life Clinical Study

This is a minimal risk, prospective, non-randomized, multi-center population based observational study to establish a physical baseline profile for individual study subjects using various modalities (blood draws, non-invasive imaging, stool samples, saliva samples) and identify deviations through longitudinal monitoring that may develop over time and may be relevant to human health and healthy longevity.

The two key elements of the PUER Research protocol include (1) molecular and laboratory profiling and (2) non-invasive imaging and wearables/ "quantified self" measurements. All elements are optional. Molecular assessments will be conducted using peripheral blood samples, and potentially urine, stool or saliva samples. Non-invasive imaging assessment will consist of magnetic resonance imaging (MRI) and computerized tomography (CT) scans, ultrasound, and x-ray. All imaging modalities are optional. Other functional assessments, including respiratory, cardiac and other functions, as well as self-quantifiable assessments via wearables, may also be conducted and are optional.

The study will result in longitudinal data collection to inform if any modalities employed here can inform of baseline deviations for individuals. Researchers at study sites will not be blinded to the data being collected during this study.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female; age 18 to 90
* Absence or presence of any medical history or any signs or symptoms of any disease
* Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at all visits

Exclusion Criteria:

* Unwillingness or inability to participate in the study
* Unwillingness or inability to provide written Informed Consent Form
* WOCBP with positive pregnancy test at enrollment or at any visit
Dose Escalation Trial of Endoluminal High-Dose-Rate Brachytherapy With Concurrent Chemotherapy for Rectal or Anal Cancer in Patients With Recurrent Disease or Undergoing Non-Operative Management

The purpose of this study is to see what amount of radiation is safe to give to rectal or anal cancer patients who are being treated with a procedure called brachytherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally residual or recurrent cancer of the rectum or anus
* Prior pelvic EBRT
* Age \> or = to 18 years
* ECOG performance status 0, 1, or 2
* At least 4 weeks from prior major surgery or radiotherapy
* Have undergone Surgical, Medical and Radiation Oncology evaluations to confirm :

  * Eligible for infusional 5-FU or capecitabine
  * Will not undergo surgery for the study disease
  * Able to receive HDR brachytherapy ANC ≥ 1.5 cells/mm3 and PLT ≥100,000/mm3
* Adequate Renal function: Creatinine \<1.5 x the upper limit of normal (ULN) or calculated creatinine clearance of ≥ 50cc/min
* Adequate Hepatic functions: Bilirubin less than 1.5 mg/dL; (except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
* AST or ALT \<3xULN, or \<5x ULN if known liver metastases
* Normal Cardiac function:

  * No active coronary artery disease;
  * No New York Heart Association class II, III or IV disease;
  * No arrhythmia requiring treatment
  * Maximum tumor length of 7 cm at time of brachytherapy treatment start

Exclusion Criteria:

* Women who are pregnant.
* Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire treatment period and after receipt of brachytherapy. Male subjects must also agree to use effective contraception during the treatment period and until 1 year after the completion of brachytherapy.
* Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
* Patients on concurrent anti-cancer therapy other than that allowed in the study.
* Contraindications to general anesthesia
Perioperative Vaping Complications

Prospective observational study evaluating the incidence, and qualifying the types, of perioperative pulmonary complications in patients that vape.

The primary objective of our study is to determine the rate at which patients that vape or use e-cigarettes experience perioperative pulmonary complications during and following general anesthesia. Complications of interest will include postoperative atelectasis with hypoxemia necessitating oxygen therapy, pneumothorax, pneumonia, bronchospasm, bronchospasm requiring bronchodilator therapy, exacerbation of underlying pulmonary disease, pneumonia, ARDS, and acute respiratory failure. Hospital course, including prolonged PACU stay, prolonged hospital admission for inpatients, and rate of ICU admissions, will also be investigated.

A secondary objective will be to further investigate and include the relationship between vaping cessation timeline in the preoperative period and the occurrence of PPCs, which is similarly underreported in the literature. Furthermore, the study will assess how effectively anesthesia providers are screening for vaping or e-cigarette use as part of the preoperative evaluation, given that "it is unclear whether anesthesiologists and surgeons routinely ask patients explicitly about vaping" in the pre-operative setting. This lack of representative screening for vaping further obscures an understanding of the relationship between vaping, vaping cessation, and PPCs.

Eligibility Criteria:
Inclusion Criteria:

* Surgical Patient
* General Anesthesia
* Hx of vaping
* Age ≥12

Exclusion Criteria:

* Age \<12
* Pregnancy
* Active preoperative pulmonary infection
* Recent pulmonary infection (within 8 weeks)
* Active tobacco smoker
* Poorly controlled reactive airway disease (requires more than PRN albuterol)
* Non-Lung Protective Ventilation
Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology

Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years old
* Individuals with a cervix and uterus
* Seeking intrauterine device (IUD) placement for contraception or management of abnormal uterine bleeding
* Meet medical eligibility for IUD placement
* Ability to consent in English
* Ability to use the visual analogue scale (VAS)

Exclusion Criteria:

* Contraindications to IUD placement
* Use of analgesics within the last 4 hours prior to IUD placement
* Presence of a pacemaker
Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder

This postmarketing observational study will evaluate the safety of ADASUVE® in treating patients with agitation associated with schizophrenia or bipolar I disorder.

This is a multicenter, prospective, observational study conducted to evaluate the safety of ADASUVE treatment when used in real-world clinical setting in patients with agitation associated with schizophrenia or bipolar I disorder.

The primary objective of the study is to assess the safety of ADASUVE treatment in real-world clinical settings.

The secondary objective of the study is to describe the characteristics of patients, including demographic and baseline characteristics, after administration of ADASUVE treatment in real-world clinical settings.

The study population will consist of a non-randomized cohort of approximately 10000 adult men and women who have agitation associated with schizophrenia or bipolar I disorder (naïve and non-naïve to ADASUVE treatment).

Eligibility Criteria:
Inclusion Criteria:

Patients may be included in the study if they meet all of the following criteria:

1. The patient is a man or woman who is 18 years of age or older at time of enrollment.
2. The patient is receiving ADASUVE for agitation in a medical or psychiatric emergency setting or in a psychiatric inpatient setting. (Note: Patients with a prior history of treatment with ADASUVE may also be included in the study.)
3. The patient (or caregiver or legally authorized representative) is willing and able to provide written informed consent (and assent, where applicable) after administration of ADASUVE treatment.

Exclusion Criteria:

There are no exclusion criteria for this study.
Acupuncture for the Treatment of Chronic Daily Headaches

The purpose of this study is to determine whether acupuncture can reduce pain in long-term headache sufferers.

Acupuncture has been shown to reduce the frequency and severity of some types of headaches, but the efficacy of acupuncture for chronic daily headaches has not been studied. The long-term goals of this study are to reduce the symptoms that are associated with recurrent headaches and to collect data that can be used for future acupuncture studies.

Participants in this study will be randomly assigned to receive 8 weeks of either standard care or ten acupuncture treatments in addition to medical care. Self-report questionnaires will be used to assess headaches and daily pain severity.

Eligibility Criteria:
Inclusion Criteria:

* Ability to communicate in English
* Presence of headache 15 or more days in the past month

Exclusion Criteria:

* Known intracranial mass
* Recent surgery to the head and neck region
Safety and Tolerability of HTI-1066 in Subjects With Advanced Solid Tumors

HTI-1066 is a novel ADC being developed for the treatment of cancers in patients with overexpression of c-Met. This 2-part, Phase 1 study evaluates the safety the tolerability of HTI-1066 in subjects with advanced solid tumors.

This is a 2-part dose escalation and dose expansion study. Dose escalation uses a modified "3+3" design and continues until a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified. In part 2, subjects with selected tumor types will be enrolled at the MTD or RP2D.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age
2. Subject must have an advanced solid tumor
3. ECOG Performance Status of 0 or 1
4. Life expectancy ≥12 weeks
5. Adequate laboratory parameters
6. Female subjects agree not to be pregnant or lactating from beginning of the study screening until 4 months after receiving the last treatment; Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception.
7. Willing and able to comply with clinic visits and study-related procedures
8. Provide signed informed consent

Exclusion Criteria:

1. Hypersensitivity to HTI-1066 or sensitivity to humanized monoclonal antibody products
2. Any concurrent therapy for cancer, radiation, or surgery within 4 weeks, except for minor palliative intent (this is to be discussed with sponsor)
3. Any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor)
4. Any other prohibited or restricted medication as described in the study protocol.
5. Investigational therapy administered \<5 half-lives before the first dose of HTI-1066
6. Any anticancer therapy administered \<5 half-lives before first dose of HTI-1066; any prior immune-oncology products administered within 4 weeks or 5 half-lives before the first dose of HTI-1066 as described above; or surgery or radiotherapy administered within 4 weeks before the first dose of HTI-1066.
7. Active CNS metastases.
8. Cardiac disease (NYHA classes II-IV) including myocardial infarction within 6 months before enrollment, or unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment.
9. History or presence of an abnormal ECG, ECHO, or MUGA that is clinically meaningful.
10. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy (e.g., hepatitis B or C)
11. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
12. Active infection or an unexplained fever \>38.5°C during Screening or on the first scheduled day of dosing.
13. Unresolved toxicities from previous anticancer therapy.
Ropivacaine After Sternotomy

Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting (CABG) or heart valve surgery to diminish postoperative pain.

A multiporous catheter will be introduced into sternotomy wound to CABG or heart valve surgery patients and continuous ropivacaine infusion 4 ml/h will be started immediately after surgery. Ropivacaine infusion will be administered during 48 postoperative hours. All patients receive patient controlled analgesia (PCA) oxycodone after extubation in the PACU. All patients receive a standardized anesthesia during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective CABG or heart valve surgery patients

Exclusion Criteria:

* Psychic disorders
* Sleep apnea syndrome
* Diabetes mellitus (insulin dependent)
* Obesity, body mass index (BMI) ≥ 35
* Cardiac insufficiency, ejection fraction (EF) ≤ 30
Ultrasound Guided Ankle Block Versus Medial Forefoot Block for Forefoot Surgery

Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and is very painful. Local anaesthetic nerve blocks have been used for many years to help alleviate pain following this surgery. The present study aims to compare a new ultrasound guided nerve block to a well established nerve stimulator guided technique. Comparisons will include time taken to carry out the block, speed of onset of numbness and duration and quality of pain relief after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Fit adult patients requiring forefoot surgery with bone cutting.

Exclusion Criteria:

* Morbid obesity (BMI \>40), known contraindications to regional anaesthesia
Imaging Studies With GE C-Hawk Gamma Camera Compared to Routine Clinical Exam

Comparison study of myocardial perfusion SPECT imaging with current clinical use camera and new camera.

Comparison study of myocardial perfusion SPECT imaging with current clinical use camera and new camera.

Eligibility Criteria:
Inclusion Criteria:

* Referral for cardiac stress testing with SPECT myocardial perfusion imaging

Exclusion Criteria:

* refusal to provide written informed consent or lack capacity to provide informed consent
Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer

The investigators conduct this study to evaluate the efficacy and adverse effect of salvage concurrent chemo-proton therapy (CCPT) with or without surgical resection in previously irradiated recurrent rectal cancer.

The obtaining of local control in previously irradiated recurrent rectal cancer is crucial for survival prolongation as well as quality of life of patients. But, it is not easy to get with surgery and/or conventional radiotherapy (RT) because of the limitation of RT dose. Proton therapy has unique advantage showing superior dose distribution focusing tumor escaping surrounding normal tissues using "Bragg-peak".

Eligibility Criteria:
Inclusion Criteria:

* previously diagnosed as rectal cancer and received curative intent treatment
* diagnosed as recurrent rectal cancer either pathology or radiologic exam
* discussed at tumor board and recommend proton therapy
* previous history of pelvic area radiotherapy
* Eastern Cooperative Oncology Group performance status of 0 to 2
* informed consent to present study
* consent to contraception for 6 months during and after study participation
* maintained bone marrow function ( absolute neutrophil count ≥ 1,2 \* 109/L, platelet count ≥ 100 \* 109/L)
* maintained renal, hepatic function creatinine clearance ≥ 50 mL/minute total bilirubin ≥ 2.2 mg/dl alkaline phosphatase ≥ 192 U/L

Exclusion Criteria:

* Pregnant and/or breastfeeding woman
* Less than 12 weeks of expected survival
* Uncontrolled active co-morbidity
Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis

OBJECTIVES: I. Determine the toxicity of cyclophosphamide and rabbit anti-thymocyte globulin in patients with diffuse systemic sclerosis.

II. Determine the efficacy of this regimen in terms of controlling disease in these patients.

PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1-2 hours on day 1 and rabbit anti-thymocyte globulin IV over 6-8 hours on days 2-5.

Patients are followed on days 60-85 and then every 3 months for 1 year.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of diffuse systemic sclerosis

Progressive disease Skin score at least 16 Interstitial or pulmonary vasculitis (FVC or DLCO no greater than 70% predicted) with evidence of alveolitis by bronchoalveolar lavage (BAL) Proteinuria (more than 500 mg/24 hours) Rapid deterioration in pulmonary function (at least 15% decrease in FVC or DLCO within the past 6 months) or new evidence of alveolitis by CT scan changes or BAL

No acute renal failure secondary to systemic sclerosis crisis

DLCO greater than 20% predicted

Ineligible for or refused autologous or allogeneic peripheral blood stem cell or bone marrow transplantation

--Prior/Concurrent Therapy--

Endocrine therapy: Concurrent prednisone allowed if prior chronic use

Other: At least 4 days since prior immunosuppressive therapy

--Patient Characteristics--

Performance status: Karnofsky 50-100%

Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3

Hepatic: Bilirubin less than 2.5 times upper limit of normal (ULN) SGOT less than 2.5 times ULN

Renal: See Disease Characteristics Creatinine clearance at least 35 mL/min No requirement for renal dialysis

Cardiovascular: Ejection fraction greater than 45% No myocardial infarction within the past 12 months No unstable angina No uncontrolled cardiac arrhythmias No evidence of congestive heart failure

Pulmonary: See Disease Characteristics

Other:

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No active uncontrolled infection
* No hypersensitivity to rabbit proteins
* No prior hemorrhagic cystitis requiring transfusion
* No concurrent active hemorrhagic cystitis by cystoscopy (if prior history)
* No concurrent malignancy