cyrilzakka/clinical-trials huggingface dataset:
Problem Solving Training and Low Vision Rehabilitation

Vision loss can result in feelings of frustration, helplessness, anxiety, depression, and anger, which compromise a person's activities of everyday living. While emotional distress may resolve in some persons without intervention, unmanaged and persistent distress places the person at risk for continued decrements in health status and the potential development of more severe conditions (i.e., depression, poor health outcomes). Persons with low vision will be recruited and randomly assigned to either an innovative, problem-solving training (PST) intervention group designed specifically for persons with low vision or a sham intervention/control group. Primary and secondary outcomes will be assessed at baseline prior to intervention and at 3 month follow-up, 7 month follow-up, 12 month follow-up, and 24 month follow-up by a research interviewer masked to participants' randomization. This project will: (1) demonstrate how specified physical and emotional outcomes of persons with low vision change across time, (2) evaluate the effectiveness of a PST intervention that will be delivered to persons with low vision; and (3) identify persons with low vision who are at risk for adverse emotional and health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* +19 yrs of age
* Underwent a low vision rehabilitation initial eye exam
* No more than 2 errors on cognitive on cognitive screening measure (SPBS)
* Must have access to telephone
* No significant hearing problems
* No significant communication problems
* Speaks fluent English
Registration of Intravenous Thrombolysis for Acute Ischemic Stroke in Southwestern China（IVTIS）

This study aims to observe the safety and effectiveness of intravenous thrombolysis for acute ischemic stroke in real-world clinical practice.

IVTIS is a prospective, real-world registry lasting for 22 years. A total of 3000 patients with intravenous thrombolysis will be enrolled。

Eligibility Criteria:
Inclusion Criteria:

* The patient was diagnosed with acute ischemic stroke and received intravenous thrombolysis.

Exclusion Criteria:

* No additional exclusion criteria.
EEG as Predictor of HD-tDCS Effectiveness in Long COVID-19

COVID-19 is an infectious disease which presents a heterogenous clinical presentation. Recent investigations suggest that people who were infected by COVID-19 often develop physical disabilities (i.e. pain, fatigue) and neurological complications after hospital discharge. Many therapeutic approaches such as transcranial direct current stimulation (tDCS) have been proposed to minimize functional and structural impairments. Electroencephalogram (EEG) has been used in this population to assess electrophysiological changes in the brain. However, evidences about EEG utilization as efficacy predictor of tDCS in COVID-19 people rest inconclusive.Our objective is to evaluate EEG as neurobiological predictor marker of tDCS efficacy on fatigue, pain, quality of life, self-efficacy and functional capacity in the chronic phase of COVID-19.

A double-blinded randomized clinical trial will be carried to analyse the EEG as neurobiological predictor marker of HD-tDCS 4x1 in patients in long COVID-19. This study is in accordance with the CONSORT guidelines, which will investigate the effectiveness of treatment with HD-tDCS.

Patients who had a medical diagnosis of COVID-19, clinically stable, able to respond to simple commands, able to walk for six minutes and who sign study consent form will be enrolled. Those who present associated neurological diseases, pregnant, users of psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers, or epileptic patients will be excluded.

Patients will be allocated randomly to the experimental group or sham control. Sessions for experimental group consist of anodal HD-tDCS on Left diaphragmatic primary motor cortex associated to respiratory training (10 sessions, 3mA, 20 minutes/session). In the sham condition, the device provided a 30-second ramp-up period to the full 3 mA, followed immediately by a 30-second ramp down.

Patients will be assessed in three moments: pre-treatment, post-treatment and after 30 days treatment ending (follow-up).

Eligibility Criteria:
Patients who had a medical diagnosis of COVID-19, clinically stable, able to respond to simple commands, able to walk for six minutes and who sign study consent form will be enrolled. Those who present associated neurological diseases, pregnant, users of psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers, or epileptic patients will be excluded.
Role of FDG PET/CT in Patients With Metastasis of Unknown Origin

Evaluatation of the role of F18FDG-PET/CT in patients with metastases of unknown origin.

Cancer of unknown primary origin (CUP) includes a cluster of heterogeneous tumors that have exceptional clinical features: it is defined as early apparent metastatic disease with no recognizable primary site at the time of presentation. The incidence of CUP ranges around 2% of all new cancer diagnoses.

The work up list of CUP include; a biopsy proven malignancy, a detailed physical examination, many laboratory, radiological and endoscopy. However, these investigations may be costly time-consuming and may eventually fail to detect the site of the primary malignant tumor in the majority of patients. In this context, positron-emission tomography (PET) combined with computed tomography (PET/CT), using the radiotracer 18F fluoro- 2-deoxyglucose (FDG) is an alternative, non-invasive imaging modality with accurate diagnostic performance. It considered good tool for diagnosis of patients with CUP . The basis for use of FDG as radiotracer for PET imaging in CUP depends on the fact that most of the malignant cancer phenotypes show an increased glucose metabolism rate.

Failure to identify the primary tumor hampers optimization of management planning, which in turn may adversely influence patient prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age more than 18 years presented with either pathologically proved metastases of unknown primary or
* Patients with clinico-radiological suspicious of having metastases.

Exclusion Criteria:

* • Age below 18 years,

  * patients with pathologically proved primary tumor,
  * Patients suffering from advanced disease and in-cooperative patients.
  * Pregnant and lactating women.
  * Patients who had motion artifacts, or those who can't stay stable or calm during acquisition.
Efficacy Testing of a Culturally Relevant Stigma Intervention With WLWH in Tanzania

This study will test a stigma reduction intervention with women living with HIV in Tanzania.

This study will test a culturally and linguistically relevant stigma reduction intervention, Labda Siku Moja, among women living with HIV in Tanzania.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria for this study are:

* (1) women who are living with HIV;
* (2) age 18 (age of adulthood as defined by the Tanzanian government);
* (3) able and willing to voluntarily consent to participate in the study;
* (4) able to travel to a data collection in their local community (as described above);
* (5) demonstrate mental competence at time of informed consent;
* (6) verbally indicate that they plan to reside in their current community for at least 6 months after enrollment (necessary to prevent attrition);
* (7) score at the median or higher level on the Swahili Version of the Multidimensional Measure of Internalized HIV Stigma Scale.

Exclusion Criteria:

* (1) any acute psychological or physiological distress; if there is evidence of acute psychologic and/or physiologic, they will be excluded from this study and referred to an appropriate site for evaluation and treatment.
* (2) Transgender women living with HIV will not be eligible to participate in this study to reduce the potential for confounding sources of stigma recognizing that a transgender identity is highly stigmatized and culturally sensitive in Tanzania. Further, it would be exceedingly difficult to recruit a sufficient sample of transgender women living with HIV to conduct an appropriate analysis.
* (3) Participants may be enrolled in other HIV-related studies except cognitive-behavioral intervention studies addressing stigma, self-efficacy, self-esteem, and/or disclosure
SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

This non-interventional study includes patients with advanced and/or metastatic renal cell carcinoma who are treated with SUTENT and who did not receive any other systemic therapy before. The aim of the trial is to increase knowledge about quality of life, safety, efficacy and tolerability under conditions of routine use of Sutent. The individual observation period of each patient will be

1 year.

The Statistical Analysis Plan provides detailed specification of the analysis

Eligibility Criteria:
Inclusion Criteria:

* First-line treatment in patients with metastatic renal cell carcinoma

Exclusion Criteria:

* Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment
Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases

The purpose of this study is to find the safest and most effective dose for delivering proton beam to the space containing CSF, brain, and spinal cord, in treating leptomeningeal metastases. The researchers think that using proton beam radiation to treat the space containing CSF, brain, and spinal cord, instead of treating only the areas where the metastasized tumor cells are causing symptoms, would improve the treatment of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: \>/= 60 years old and no menses for 1\> year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment.
* Patient with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology.
* KPS ≥ 60.
* Age ≥ 10 years.
* For adult patient, the patient is able to provide informed consent. For pediatric patient, a parent is able to provide informed consent.
* Patient at reproductive potential must agree to practice an effective contraceptive method.
* Adequate bone marrow function:

  * Hemoglobin ≥ 8g/dL
  * Absolute neutrophil count ≥500/mm\^3
  * Platelet count ≥ 100,000/mm\^3

Exclusion Criteria:

* Patient with multiple, serious major neurologic deficits including encephalopathy.
* Patient with extensive systemic disease and without reasonable systemic treatment options.
* Patient who is unable to undergo MRI brain and spine with gadolinium contrast.
* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
* Pregnant or lactating women.
Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin

Adult participants will apply a broccoli sprout extract-jojoba oil compound to one arm every night under occlusion for 1 week. Jojoba oil alone will be applied to the other arm. At the end of 1 week, a 6mm punch biopsy will be taken from both arms and analyzed via polymerase chain reaction (PCR) and immunohistochemistry for differences in various skin proteins.

10 adult volunteers, including African American, Caucasian, male and female participants, will be recruited from parents of patients seen in the pediatric dermatology clinic. Each participant will receive 7ml of broccoli sprout extract (BSE) in jojoba oil, containing 3500nmol of sulforaphane (Please see the preparation of broccoli sprout extract below). 500nmol of sulforaphane will be applied each night. The participants will apply the BSE-jojoba oil mixture over a circle, 3cm in diameter, on the upper arm every night for 7 consecutive nights. The control arm will have only jojoba oil applied. Both arms will be occluded with saran wrap every night. After the seventh night, the volunteers will have a 6mm biopsy taken from each arm (2 total), performed by a dermatology resident. The biopsies will be cleaned with alcohol, numbed with 0.5-1cc of 1% lidocaine with epinephrine, and closed with one 4-0 nylon nonabsorbable suture. The biopsy site will be covered with Vaseline and a bandaid. The area will be kept covered for 24 hours, after which it may be washed with soap and water and then recovered with Vaseline and a bandaid. The suture will be removed 10-14 days after the procedure. From the initial visit through the final visit for suture removal, we expect the duration of the trial to last approximately 1 month. The participants will be told to avoid applying any topical medications or over the counter lotions or creams for the duration of the study and will also be told to wash with Dove soap in the shower. They will also be advised to avoid a diet high in cruciferous plants such as broccoli, mustard, and horseradish. The biopsy results will each be divided in half. One half to be frozen for cryosectioning and immunofluorescence staining and the other half to be used for protein or RNA extraction for molecular assays (real time polymerase chain reaction and/or quantitative polymerase chain reaction for select messenger RNAs and western blotting for select protein antigens). The levels of keratin 1, keratin 5, keratin 10, keratin 14, keratin 16, keratin 17, and Nrf2 will be studied with both immunofluorescence and RNA PCR.

Eligibility Criteria:
Inclusion Criteria:

* Able to attend 3 visits at the designated times.

Exclusion Criteria:

* Pregnant
* Known allergy to broccoli, lidocaine, or epinephrine
Feature Assessment Study for Indications Based Programming

The purpose of this evaluation is to assess the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications when using the feature 'Indications Based Programming' (IBP) available in the ZOOMVIEW Software Application for the TELIGEN DR / VR and COGNIS family of devices compared to daily life programming chosen by physicians.

"This study will focus on documenting the final parameter changes that are made in comparison to the IBP recommendations for a specific cardiovascular and arrhythmia history. It will therefore compare the device settings that were finally programmed during the last available follow up procedure to the last available parameter recommendations of IBP. IBP was designed to facilitate programming by providing customized parameter settings based on a patient's clinical needs and primary indication.

In order to further enhance the IBP feature for future device generations, additional data may be collected and evaluated on:

* Physician perception and satisfaction with the New User Interface (NUI) of the programming application;
* Motivation for adapting IBP recommendations for the final programming of the device;
* Device data that can be retrieved from patient data disks that may include but is not limited to, arrhythmia episode detail, pacing counter data; total and individual therapy data"

Eligibility Criteria:
Inclusion Criteria:

* indicated for implantation of an ICD or CRT-D device according local hospital implant criteria guidelines

  * Implanted or intended to be implanted with any CE-marked device approved for implant from the TELIGEN (single or dual chamber ICD) or COGNIS (CRT-D) family during first implant (no replacements)
  * Geographically stable patients who are available for follow-up at a study centre
  * Age 18 or above, or of legal age to give informed consent specific to national law

Exclusion Criteria:

Inability or refusal to sign the Patient Informed Consent

* Pregnant or planning to become pregnant
* Replacement device
* Enrolment in another clinical trial, study or evaluation
* Estimated life expectancy of less than six months per discretion of physician
Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer

This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally advanced or metastatic breast cancer will be enrolled into the Phase II portion of the trial to further evaluate the safety and efficacy of CR011-vcMMAE.


Eligibility Criteria:
Main Inclusion Criteria:

* Females with confirmed breast cancer
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
* Locally advanced or metastatic disease who have received at least two prior chemotherapeutic regimens for breast cancer, as follows:

  * At least one regimen must have been for locally advanced or metastatic disease
  * Subject must have received an anthracycline, a taxane, and capecitabine in any combination unless the subject was intolerant to or not a candidate for any of these agents
  * Hormonal therapy, biologic therapy (such as trastuzumab or bevacizumab), or immunotherapy do not count as one of the 2 regimens
  * Subjects with HER2/neu overexpressing tumors must have been treated with trastuzumab except in situations where the subject was intolerant to or not a candidate for trastuzumab
* Documented progressive disease within 6 months of the last regimen
* Adequate bone marrow, renal and liver function
* Signed informed consent

Main Exclusion Criteria:

* Chemotherapy, radiation, hormonal therapy, or bevacizumab within two weeks, or trastuzumab or investigational therapy within three weeks before treatment start
* Neuropathy \> NCI-CTCAE Grade 1
* Active brain metastases.
* New York Heart Association class III or IV heart disease
* Unstable angina
* Uncontrolled arrhythmia
* A marked baseline prolongation of QT/QTc interval
* Pregnant or breast-feeding women, and women of childbearing age and potential who are not willing to use effective contraception
Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study (ANSYSCAP)

A single center observational study. Observing the time between cerebrovascular symptoms and Carotid Endarterectomy (CEA) and patient outcome. An intervention at 17 of the 29 study months aimed at reducing the delay and increasing the patient safety. Main outcome is to measure the reduction in recurrent stroke with decreased delay to CEA.

All patients with a carotid stenosis \>50% according to the NASCET-criteria are included. The study does not affect the health care the patients receive. The time between symptom and surgery is compared to the outcome of the CEA after 45 days, 6 months, 1 year and 5 years. An intervention in the form of new practical local and regional guidelines in January 2009 (#17 of the 29 study months) aimed at reducing the delay and increasing the patient safety.

PRIMARY AIM:

To study the risk of Ipsilateral stroke, any stroke, death, any cerebrovascular event, any cardiovascular event.

Two primary analyses:

1. Ipsilateral ischemic stroke within 90 Days of the presenting event. This analysis is aimed at the short term risk of pre-operative stroke. Survival analysis will be used. CEA will be used a censor, thus excluding all peri-operative and postoperative strokes.
2. All primary endpoints within 5 years of the presenting event. This analysis is aimed att the long term risk of cardio-vascular morbidity and mortality.

Secondary analyses:

1) Same as first primary analysis, but including all stroke as endpoint, not only ipsilateral ischemic stroke.

SECONDARY AIM:

To attempt to validate different risk and score systems already published by other sources. Such as can ABCD2-score be used safely to chose between acute and fast normal screening for carotid stenosis?

Eligibility Criteria:
Inclusion Criteria:

* Carotid stenosis \>50% according to NASCET criteria

Exclusion Criteria:

* Not preliminary judged as having an indication for surgery, before an extensive investigation is launched. Thus, some patients that will not undergo CEA will be included.
Amniotic Membrane Wrapping and Tenolysis Versus Tenolysis Alone for Treatment of Tendon Adhesions of the Hand/Wrist

Tendon adhesions of the hand remain a ubiquitous problem facing hand surgeons and hand therapists alike. Despite their commonality, no consensus exists as to the best means of preventing adhesions, or the most ideal methods to treat them once they have occurred. The purpose of this study is to compare patient outcomes after standard operative tenolysis performed for adhesions of the hand to outcomes after tenolysis with the use of allograft human amniotic membrane.

Patients who are scheduled to undergo operative tenolysis of the flexor and/or extensor tendons of the hand will be recruited. Our target enrollment is 40 patients (20 control plus 20 experimental), based on the power analysis detailed in the next paragraph. Enrolled patients will be randomized to either standard operative tenolysis, or tenolysis with placement of AlloWrap. Randomization will be performed by computerized random number generator. All surgeries will be performed by one senior fellowship-trained hand surgeon. Baseline measurements of total active motion (TAM), passive range of motion (PROM), and survey scores of the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) and Patient Rated Wrist Evaluation (PRWE) will be recorded pre-operatively. In addition, patients' pain level will be assessed using the visual analog scale (VAS) both at rest, and during the examination. These same values will be re-evaluated at post-operative follow-up visits at 2 weeks, 1 month, 3 months and 6 months. PROM will also be evaluated intra-operatively by the surgeon, and documented.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients deemed candidates for operative tenolysis of the hand or wrist
* Age ≥18

Exclusion Criteria:

* Patients younger than 18 years at the time of surgery;
* Any patient who would not be able or willing to comply with the protocol or perform assessments;
* Patients with medical conditions that may preclude placement of human biological membrane;
* Patients who have previously undergone tenolysis on the operative hand;
* Patients that will have multiple surgeries that are deemed as possible confounders, particularly those requiring an additional incision;
* Is physically or mentally compromised (i.e. being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to participate in the clinical study;
* Is a prisoner;
* Is a transient.