cyrilzakka/clinical-trials huggingface dataset:
PSMA-based 18F-DCFPyL PET/CT: Evaluating Its Application in Real Life

The purpose of the study is to provide pilot data on the clinical situations in which ordering a 18F-DCFPyL positron emission tomography/computed tomography (PET/CT) was thought to be clinically useful, and to document how the results of the 18F-DCFPyL PET/CT affected patient management. The results of this study could then serve as a guide to help OHIP to consider these scenarios when deciding the precise indications for funded 18F-DCFPyL PET/CT scans in the future. In this study the investigators will image subjects with prostate cancer using 18F-DCFPyL PET/CT and record how the result of the study affected patient management.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Age ≥ 18 years and male
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* One of the following:
* CT scan showing indeterminate lymph node(s) in the pelvis that could potentially be treated radically with radiotherapy if found to be positive on PSMA PET.
* Suspected oligometastatic disease (\< 4 sites of disease) that could potentially be treated with stereotactic/radical doses of radiotherapy.

Exclusion Criteria:

* Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
* Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg)
* Condition or situation which, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study
* Not willing to comply with the procedural requirements of this protocol
* Subjects who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.
Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study

Multiple dose safety and pharmacokinetics in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
A Novel Method of Clipped Axillary Lymph Node Localization Post Neoadjuvant Chemotherapy in Breast Cancer Patients .

to determine the feasibility of a novel technique of localization of clipped LN post neoadjuvant chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* breast cancer patients with involved axillary LN \<3,
* going for neoadjuvant chemotherapy

Exclusion Criteria:

-stage 4 breast cancer patients
Cluster-randomized Controlled Trial of Mindfulness-Based Cognitive Therapy Effects on Anxiety and Stress

To understand the potential effectiveness of a 4 week Mindfulness-Based Cognitive Therapy intervention delivered using a smartphone application for reducing anxiety and stress within college students.

The objective of this project is to understand the potential effectiveness of a 4 week Mindfulness-Based Cognitive Therapy intervention delivered using a smartphone application for reducing anxiety and stress within college students. Although in-person mindfulness-based cognitive therapy approaches have been found effective for reducing anxiety and stress; given the pervasiveness of anxiety and stress in this population, there is a need to provide alternative and accessible interventions to improve students' mental health. One such approach may be by leveraging existing tools such Sanvello - a free mindfulness-based cognitive therapy smartphone application - which could more easily be deployed across a broader population. Accordingly, using a cluster-randomized controlled design, this intervention will assess the extent to which 4-weeks of using the Sanvello application was effective for reducing anxiety and stress within college students.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in course

Exclusion Criteria:

* Complete inattendance in course during the pretest and study period.
* Opted out of data being available for research use
Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

This study is designed to compare laparoscopic and vaginal hysterectomy in women with benign gynaecological disease in Ain Shams University Maternity Hospital.

The current trial evaluates the performance and short-term postoperative outcomes of these two approaches for hysterectomy in Ain Shams University Maternity Hospital, a major tertiary hospital in Greater Cairo, and one of Egypt's leading centers in terms of provision of public medical service.

Eighty patients with benign indications, with no contraindications to neither laparoscopic nor vaginal approaches, were randomized into two equal groups, to undergo either of the two procedures: LH or VH.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing hysterectomy for benign gynaecological disease (e.g., dysfunctional uterine bleeding, adenomyosis, fibroids).

Exclusion Criteria: Women with:

* known tubo-ovarian pathology requiring primary laparotomy, e.g. large adnexal masses
* known neoplasia requiring pelvic lymphadenectomy
* pelvic organ prolapse requiring additional procedures, e.g., uterine procidentia (complete prolapse), enterocoele
* conditions interfering with laparoscopic surgery, e.g. cardio-pulmonary disease, obesity (BMI 30 kg/m2 or more)
* large uteri interfering with vaginal hysterectomy (size \>16 gestational weeks)
Safety, Tolerability, and Pharmacokinetic (PK) Study of DHES0815A in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Breast Cancer

This first-in-human, Phase 1, open-label, multicenter, dose-escalation study will evaluate the safety, tolerability, and PK of DHES0815A as a single agent in participants with advanced and/or metastatic HER2-positive breast cancer for whom established treatment has proven ineffective or intolerable or is unavailable. The study may include a dose-expansion cohort (based on an ongoing assessment of the totality of data obtained in this study) to further assess safety, tolerability, PK, and preliminary anti-tumor activity.


Eligibility Criteria:
Key Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Measurable disease by RECIST v1.1 with at least one measurable target lesion
* Locally advanced or metastatic HER2-positive breast cancer that has relapsed or is refractory to established therapies
* Adequate hematologic and end-organ function
* For dose-expansion cohort only: no more than two prior systemic chemotherapy-containing regimens in the advanced/metastatic setting (excluding trastuzumab emtansine, which is considered a targeted cytotoxic agent)

Key Exclusion Criteria:

* Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4 weeks prior to initiation of DHES0815A
* History of exposure to the protocol specified doses of anthracyclines
* Pregnancy, lactation, or breastfeeding
* Major surgical procedure within 4 weeks prior to Day 1
* Evidence of a significant uncontrolled concomitant disease of the nervous system, pulmonary, autoimmune, renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture
* Known active bacterial, viral, fungal, mycobacterial, or other infection
* Clinically significant history of liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
* Untreated or active central nervous system (CNS) metastases
* Cardiopulmonary dysfunction, including inadequate left ventricular ejection function at baseline, less than 50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
* QT interval corrected through use of Fridericia's formula (QTcF) \> 470 milliseconds (ms)
Joint Attention Intervention and Young Children With Autism

The purpose of this study is to investigate the effectiveness of an intervention aimed to increase joint attention in 2-4 year old children with autism. The study will be conducted in mainstream preschools in Norway. The intervention will be implemented by preschool teachers and paraprofessionals supervised by trained counselors.

Young children with autism experience severe deficit in joint attention skills (e.g. pointing to objects, showing, following another person's gaze, responding to invitations to social interaction). Ability to initiate and respond to joint attention is linked to children's later language abilities. As a mean to improve language outcome in children with autism, it is important to target joint attention in early intervention programs.

This study investigates the effectiveness of a joint attention intervention. Sixty 2-4 year old children with autism will be randomized to an intervention group or a control group. Children in both groups will continue their ordinary preschool program. However, the children in the intervention group will also participate in 80 joint attention intervention sessions. The sessions (20 minutes each) will be conducted twice a day for 8 weeks by preschool teachers or paraprofessionals working in the preschools. Before starting the intervention preschool teachers and paraprofessionals will be taught how to teach joint attention skills and how to initiate and maintain episodes of joint engagement. During the course of intervention they will be supervised by trained counselors.

Outcome measures will include joint attention skills, language skills and joint engagement. Children will be assessed at baseline, after 10 weeks and at follow up 6 months and 1 year after the end of the intervention. The measures are based on direct testing of the children, video observations and questionnaires to parent and professionals.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of autism
* age 2-4 year old

Exclusion Criteria:

* severe mental retardation
* severe clinical CNS disorders
Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy

The purpose of this study is to compare the safety and efficacy of Preservon(TM) treated allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or myelopathy.

Patient follow-up will be conducted at 6 weeks, 3 months, and 6 months. At 3 months after surgery, the implanted bone dowels will be assessed for subsidence; at 6 months after surgery, the implanted bone dowels will be assessed for fusion. Patients will complete questionnaires and x-rays taken at each visit.

The degree of subsidence and rate of fusion will be assessed based on the evaluation of the x-rays taken. The x-ray evaluation will be conducted by a neurosurgeon who is blinded to the type of treatment that each patient has received.


Eligibility Criteria:
Inclusion Criteria:

* Patient is skeletally mature
* Patient has confirmed radiculopathy or myelopathy
* Pain unresponsive to non-operative treatment
* Radicular pain in either or both upper extremities
* Neurological deficit in distribution of nerve root from C3/4 to C6/7
* Patient's lateral cervical spine x-rays show inferior aspect of lowest vertebral body to be fused
* Patient agrees to comply with protocol
* Patient can provide voluntary informed consent and follow-up information

Exclusion Criteria:

* Patient has previous cervical spine surgery
* Patient requires concurrent posterior surgery at level to be treated, or anterior and posterior surgery at any other cervical level
* Patient has clinically compromised vertebral body structure
* Patient has multi-level fixed/ankylosed cervical spine
* Patient has signs of significant instability at level to be treated or adjacent level
* Patient has history of metabolic bone disease
* Patient is taking chronic oral/IV corticosteroid therapy OR medications that potentially interfere with bone/soft tissue healing
* Patient has progressive neuromuscular disease, rheumatoid arthritis, active malignancy, OR any other condition that interferes with self-assessment of pain, function, or quality of life
* Patient has OPLL at any level
* Patient has active infection, local or systemic
* Patient is pregnant or considering pregnancy (x-ray requirements)
* Patient is participating in another investigational study
* Patient belongs to vulnerable population
UPHS Weight Loss Study

The goal of this study is to compare a novel approach using financial incentives to changes in health benefit design and their impact on employee weight loss.

Employers are increasingly looking for opportunities to encourage weight loss among employees. While studies have shown that financial incentives can effectively encourage weight loss, little is known about their use in health benefits design. The goal of this study is to determine whether a financial incentive program delivered to obese University of Pennsylvania Health System employees can effectively encourage weight loss when compared to changes in health benefit design.

This is a randomized controlled trial involving financial incentives with four study arms: control, delayed gratification, immediate gratification, and financial incentive with frequent feedback. Participation in this study will last about 12 months.

The primary goal of the study is to test the effects of a novel financial incentive program using a lottery with frequent feedback to normal benefit design structures.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18-70
* BMI of 30 or above

Exclusion Criteria:

* Inability to consent
* Illiteracy and/or inability to speak, read, and write English
* Participation in another research study

Conditions that would make participation unsafe:

* Current treatment for drug or alcohol use
* Consumption of at least 5 alcoholic drinks per day
* Myocardial infarction or stroke within the past 6 months
* Current addiction to prescription medicines or street drugs
* Serious psychiatric diagnoses (e.g., severe major depressive disorder, bipolar disorder, schizophrenia)
* Pregnant or currently breastfeeding
* Diabetic and using any medicine besides metformin to control blood glucose
* Metastatic cancer
* Unstable medical conditions that would likely prevent the subject from completing the study
* Previous diagnosis of an eating disorder
* History of unsafe weight loss behaviors such as binging or the use of laxatives
Effect of Systemic Inflammation on Emotion and Cognition in Patients With Mood Disorder - A Vaccine Study

The purpose of this pilot study is to investigate and compare the effect of a mild inflammatory stimulus (typhoid vaccine) on immune response, mood and cognition in healthy volunteers compared to patients with history Major Depressive Disorder (MDD) (not currently depressed and no symptoms of depression in the past 6 months).

Study design: In this double blind randomized crossover design, each participant will receive saline injection or typhoid vaccine injection at the first study visit, and will then receive the other injection at the second study visit. All participants will undergo study procedures (clinical and imaging) in two separate sessions after each injection given at least 7 days apart (within 10-14 days).

Baseline blood samples will be taken and vital signs will be measured. Participants will be asked to complete the mood questionnaires and computerized reward tasks. Then, injections of normal saline will be administered intramuscularly in the deltoid muscle. At 1.5h, 3h, 4h and 6h after the injection, the subjects will complete the mood questionnaires and vital signs will be assessed. The computer based task will be repeated at 3h.

Between3h and 6h after the injection blood samples will be collected for cytokines measurement. At 4h, a structural magnetic resonance imaging (MRI), and Functional magnetic resonance imaging (fMRI) will be done.

Follow up visits/calls with the patients will be set to check their physical and mood status.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, male or female; aged 18-65
* Subjects with history of Major depression (currently asymptomatic - symptom free for more than 6 months)
* Medication free, if not feasible being on antidepressants will be allowed

Exclusion Criteria:

* Volunteers who received this vaccine within 3 years or any other vaccine within 3 months
* Patients with existing inflammatory conditions (connective tissue disorder, autoimmune conditions, neoplastic disease, chronic infections, etc.)
* Patients with acute viral or bacterial infection
* Hospitalized patients
* Patients in acute phase of illness
* Current active medical condition that affect brain anatomy, neurochemistry, or function, e.g. liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any brain disorder (seizure disorder, stroke, dementia, degenerative neurologic diseases)
* History of any brain diseases, including seizures, stroke, meningitis, encephalitis, dementia, degenerative brain diseases, and serious head injury with loss of consciousness
* Family history of hereditary neurologic disorder
* Floating metallic objects in the body
* Pregnancy
* Exposure to regular use of anti-inflammatory drugs in the last one month
* Excessive exercise, consumption of caffeinated beverages or alcohol, high-fat meals 12 hours before testing
* History of tobacco, alcohol, or drug abuse or dependence.
* History of allergic reaction to vaccination or serious allergic reaction to shellfish or egg allergy
Culturally-focused Consultation for Asian Americans and Latino Americans

The purpose of this study is to determine if a culturally focused psychiatric (CFP) consultation service can improve depressive symptoms and increase diagnosis and treatment of depression in Asian American and Latino American primary care patients at the Massachusetts General Hospital.

This study's aim is to determine if a culturally focused mental health consultation will help Latino and Asian Americans who are experiencing sadness, stress, or other symptoms of depression. Eligible adults must already have a primary care physician at Massachusetts General Hospital.

In this study, patients will be randomly assigned, like the flip of a coin, to receive the culturally focused intervention or treatment as usual. Those who receive the intervention will have three sessions with study personnel, during which they will generally discuss and learn techniques for dealing with their mental health. Those who receive treatment as usual, meaning the regular care they receive through their primary care practice, will have two sessions with study personnel during which they will generally discuss their mental health. All study visits and patient materials are provided in patients' language of choice - English, Spanish, Mandarin, Cantonese, or Vietnamese. All patients will be compensated for completing study visits.

About half of the study patients in both arms will also be invited to participate in optional qualitative interviews, in which they will be asked questions about their expectations for the research study and their ideas for improving culturally sensitive mental health services. In addition, a small sample of Asian American patients who did not participate in the study but who have PCPs at the sites where the study was conducted will be contacted for a qualitative interview. This interview will address reasons why Asian American recruitment for the study was so challenging.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent
* Adults 18 years of age or older
* Members of either Asian American or Latino American minority groups
* Currently experiencing depressive symptoms

Exclusion Criteria:

* Active unstable, untreated psychiatric illness precluding participation in study
Window of Trainability in Relation to Surgical Correction of Foot Deformity

Background: Stroke is the leading cause of disability in the western world. In chronic stroke patients, foot deformity such as pes equinovarus is among the most important underlying motor deficits, due to imbalance of muscle strength and activity around the ankle and tarsal joints. Both nationally and internationally, there is relative underuse of surgical treatment options, although in our clinical experience this often has the best outcome. In addition to positive clinical experiences with surgical interventions, we have experienced that before surgery, there is limited effect of gait training on gait capacity. However, we have experienced that after surgery, the restored normal ankle-foot position creates a new window for training opportunities to further improve gait capacity. Therefore, in this exploratory proof of principle study we aim to investigate the effect of surgical correction of post-stroke foot deformity on the (potential) improvement of gait capacity after gait training. Based on clinical experiences, we expect that after surgery, gait training results in a larger improvement in gait capacity compared to before the surgical intervention due to the increased possibilities to improve balance control.

Objective: The primary objective of this study is to compare the effect of gait training on gait capacity (stepping performance, gait adaptability and dynamic balance) before and after surgical correction of post-stroke foot deformity.

Study design: Exploratory proof of principle study with repeated-measures. Study population: Fifteen stroke patients with disabling foot deformity will be recruited from the Gait Expertise Center (LEC) of the Sint Maartenskliniek and Radboudumc.

Intervention: All patients will receive two gait training interventions, each consisting of twelve one hour training sessions. The training sessions will be focussed on improving gait capacity.

Main study parameters/endpoints: Primary outcomes will be gait adaptability as measured with the Emory Function Ambulation Profile (E-FAP), stepping performance as measured with the Timed-Up-And-Go test (TUG) and dynamic balance as measured with the Margin of Stability (MoS).


Eligibility Criteria:
Inclusion Criteria:

* \> 6 months post onset
* 18 years or older
* Functional Ambulation Classification (FAC) =\> 3: the patient is able to walk without physical support
* Will undergo a surgical correction of foot deformity

Exclusion Criteria:

* suffers from any other disorder that seriously affects gait capacity