cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Survivorship Wellness Group Program for Patients Treated at University of California, San Francisco (UCSF)

Interdisciplinary psychological interventions targeting survivorship are not only understudied but face several implementation challenges. For this project, the study team is proposing to analyze these data to report on preliminary pilot outcomes, as well as acceptability and feasibility of the implementation of the Survivorship Wellness Group Program, an interdisciplinary wellness and health-behavior change program for survivors of cancer, who have completed treatment at University of California, San Francisco and are currently without evidence of active disease.

STUDY OBJECTIVES:

1. To examine the feasibility and acceptability of implementing an interdisciplinary goal-setting clinical group program focused on domains of physical, psychological, and spiritual wellness for survivors of cancer at University of California, San Francisco.
2. To determine preliminary efficacy of the Survivorship Wellness intervention in regards to:

   1. Increasing knowledge of and perceived confidence in execution of health behavior changes in domains of physical, emotional, and spiritual wellness for survivors of cancer
   2. Increasing quality of life
   3. Reducing symptoms of depression and anxiety
   4. Increasing physical activity

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Treated for any kind of cancer at University of California, San Francisco, though finished with active treatments (defined as chemotherapy, radiation, or surgery) at time of enrollment, and without evidence of current active cancer
* Sufficient cognitive ability to participate in group activities as determined by their attending medical oncologist or surgeon

Exclusion Criteria:

* Non-English speaking
* Primary cancer treatment outside of UCSF
* Currently receiving non-maintenance therapies (chemotherapy or radiation) for active cancer
* Psychiatric illness that would affect the ability to participate in a group activity
Effects of NAVA and PSV to AECOPD Patients' Air Distribution and Dead Space

Chronic obstructive pulmonary disease(COPD) is a common disease among people. Acute exacerbation of chronic obstructive pulmonary disease(AECOPD) is the acute and aggravating phase of COPD which may lead to respiratory failure. Mechanical ventilation is a very important therapy for those patients,but traditional ventilation modes have some defects, so investigators need to find new modes to solve these problems. In this study, the investigators compare neurally adjusted ventilatory assist (NAVA) and PSV to observe the effects on AECOPD patients' air distribution and dead space to determine if NAVA is a more appropriate ventilation mode for AECOPD patients.


Eligibility Criteria:
Inclusion Criteria:

* AECOPD patients who need invasive mechanical ventilation
* Patients who can tolerate assist mechanical ventilation
* Patients who have signed ICF

Exclusion Criteria:

* Patients who are younger than 18 years old or older than 75 years old
* Patients whose respiratory center is severely inhibited
* Patients who can not stand NAVA gastric tube
* Patients who have coagulation disorders
* Patients whose vital signs are unstable
* Patients who are in other clinical trails
Prevalence of Musculoskeletal Pain and Its Impact on Quality of Life and Functional Exercise Capacity in Patients With Pulmonary Arterial Hypertension

Prevalence of musculoskeletal pain and its impact of quality of life and functional exercise capacity will be evaluated in patients with pulmonary arterial hypertension.

Although main symptoms of pulmonary arterial hypertension (PAH) include shortness of breath and exercise intolerance, patients may also experience symptoms related to musculoskeletal system such as muscle fatigue or pain. Due to insufficient cardiac output and chronic arterial hypoxemia, oxygen cannot be delivered to skeletal muscles sufficiently, especially during exertion. In addition, inflammation, which is thought to play an important role in pulmonary vascular remodeling and disease pathophysiology in these patients, affects skeletal muscles as well. Increased sympathetic tone in PAH restricts the perfusion of skeletal muscle by increasing peripheral vascular resistance. With the addition of physical inactivity to all these factors, skeletal muscle metabolism is further impaired. Furthermore, drugs used for the treatment of PAH may induce musculoskeletal pain as a side effect. Musculoskeletal pain is one of the most important factors impairing individual's quality of life, regardless of whether there is an underlying disease. Our aim in this study is to evaluate pain prevalence in the musculoskeletal system over 9 body regions, to compare the pain prevalence of patients using different types of PAH drugs and to examine impact of musculoskeletal pain on quality of life and functional capacity in patients with PAH.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pulmonary arterial hypertension

Exclusion Criteria:

* Diagnosis of heart failure or any chronic respiratory disease
* Recent coronary bypass surgery
* Recent acute myocardial infarction
* Having a pacemaker
* Having any orthopedic or neurologic diseases which may impede walking or exercising
Systems Saving Lives - Long-term Survival of Out-of-hospital Cardiac Arrest in the Urban Area of Bologna

Evaluation of clinical, logistical, and technical factors (e.g. implementation of pre-arrival instructions, implementation of the DAE RespondER, mechanical chest compressor, REBOA, and E-CPR) that impact on the outcomes of out-of-hospital cardiac arrest patients.


Eligibility Criteria:
Inclusion Criteria:

* Out of Hospital cardiac arrest patients (historical cohort) from 1st January 2009 and 30th June 2020
* Out of Hospital cardiac arrest patients from 1st July 2020 and 31st December 2025

Exclusion Criteria:

* False cardiac arrest
* In-hospital cardiac arrest
The Role of Tc 99m MDP SPECT/CT in Osteoarthritis

Evaluation of the diagnostic value of SPECT/CT in patients with knee and/or hip OA, whether it is related to clinical findings and it could reflect clinical disease activity, and to determine the usefulness of SPECT/CT in early detection of OA.

Osteoarthritis (OA) is a slowly developing chronic degenerative joint disease that progresses over years. After the classification and reporting of OA were established by American College of Rheumatology in 1986, the diagnosis has depended on the patients' symptoms and supported by plain radiographic findings.

Since X-ray image has a discrepancy with clinical findings, the therapeutic modalities tend to depend on the clinical symptoms, rather than the objective imaging findings.

MRI is a non-invasive and a very sensitive tool in detecting the early bony change such as bone marrow oedema, but it has some limitation in that it may have false positive or false negative results in the detection of the patella-femoral (PF) lesions. Bone scintigraphy is relatively sensitive because it reflects the early physiological changes of joints. But its image is planar that it cannot give enough information for the anatomic localization, and the image is overlapped.

To compensate for the defects of these imaging methods, bone single photon emission computed tomography (SPECT) has emerged as useful imaging tools in the diagnosis of OA.

Based upon the fact that subchondral bony changes precede joint space narrowing in OA, bone SPECT seems to be a very useful tool in early OA, reflecting the early bony changes.

The use of SPECT/CT offers the benefit of combined anatomical, mechanical (CT) and functional imaging (SPECT), which represents a relevant improvement in preoperative diagnosis and follow-up after procedures.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient above 30 years old.
* Clinically diagnosed osteoarthritis before treatment.
* Patient with refractory active osteoarthritis (not responding to treatment).
* Ability to sleep in fixed position for about 25 minutes
* Ability to provide informed consent.

Exclusion Criteria:

* Patient with resolved osteoarthritis.
* patient with other disease in joints:

  * Avascular necrosis
  * Stress fracture
  * Neuropathic pain
Treatment of Distal Radius Buckle Fractures

This study determines if patients with buckle fractures of the distal radius and/or ulna treated with supportive care only demonstrate non-inferior outcomes in regard to pain control during healing, functional outcome at the wrist joint, and parental satisfaction, when compared with patients treated with the standard treatment regimen of 3-4 weeks in a short arm cast.


Eligibility Criteria:
Inclusion Criteria:

Children age 1-17 with buckle fractures of the distal radius and/or ulna. -

Exclusion Criteria:

* Patients are excluded if there is any other injury to the upper limb or serious bodily trauma that might complicate pain scores. Children with suspected or proven metabolic bone disease, or pathologic fractures are excluded due to resultant abnormal bone healing.
Evaluation of an Adaptative, Multidisciplinary, Reach-out Program, Facilitating Pre Exposition HIV Prophylaxis (PrEP) Prescription and Retention in Care, in a Group of Trans Womens (TW) at High Risk of HIV Infection.

Evaluation of an adaptative, multidisciplinary, reach-out program, facilitating pre exposition HIV prophylaxis (PrEP) prescription and retention in care, in a group of trans womens (TW) at high risk of HIV infection.


Eligibility Criteria:
Inclusion Criteria:

* Trans woman ≥ 18 years old; Negative HIV-1 and HIV-2 serology; Participant on PrEP or request to start PrEP or reporting present, past or future exposure to HIV; Participant agreed with the constraints imposed by the study (every 3 months visits); Non opposition.

Exclusion Criteria:

* Subject with positive HIV serology; Subject with clinical signs suggesting a primary HIV infection; Subjects planning to travel/live abroad for more than 3 consecutive months or planning to live outside Ile-de-France region; Creatinine clearance \< 60 mL/min (Cockroft's formula); History of chronic kidney disease, osteoporosis, osteopenia; Subject receiving a potentially nephrotoxic treatment (long-term nonsteroidal anti-inflammatory drugs); Ongoing post-exposure antiretroviral therapy (the participant may be tested 6 weeks after the end of treatment); Treatment under investigation; Chronic gastrointestinal illness (or chronic nausea or vomiting) interfering with intestinal absorption; HBs antigen positive or with an isolated anti-HBc antibody if participant is not ready to take continuous PrEP; Life-threatening illness (cancer) or other serious illness (cardiovascular, renal, pulmonary, unstable diabetes) which would require treatment that could interfere with treatment adherence; Hypersensitivity to one of the components of TDF / FTC.
Immunogenicity and Safety of 2 Schedules of ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients

Prior pilot studies have shown that four monthly injections of ALVAC-HIV (vCP1433) are immunogenic in 60% HIV-infected patients with a boosting effect obtained after 1 or 2 injections followed by a plateau or a decrease of these responses prior to interrupting therapy. The goal of the present study is to look for an improved vaccination schedule in terms of strength and duration of the HIV-specific immunity induced by the HIV-recombinant canary pox vector ALVAC-HIV (vCP1452) by testing a strategy of immunization involving a first series of two versus three monthly injections followed by a boost three months later.

Manon 02 is a phase II, multicentre, randomized, placebo-controlled study with 3 arms comprising 2 steps:

Step I : Immunization phase from W0 to W24, on HAART

The immunization will be administered by intramuscular injection :

Arm A: one injection of vCP1452 at W0, W4, W8 and W20 + HAART, for a total of 4 injections Arm B: one injection of vCP1452 at W4, W8 and W20 + HAART, for a total of 3 injections Arm C: one injection of placebo at W0, W4, W8 and W20 + HAART, for a total of 4 injections or at W4, W8 and W20 + HAART, for a total of 3 injections

Step II: Post immunization phase from W24 to W48, off HAART

Discontinuation of antiretroviral therapy (ARV) from W24 to W48 :

The ARV treatment interruption will be proposed at W24, 4 weeks after the last immunization, to patient who had completed their immunization phase and have CD4 cell counts \> 350 cells/mm3 and HIV plasma RNA \< 400 cp/ml.

In order to be able to evaluate the capacity of the immune response to reduce the viral replication, a period of 16 weeks of interruption is recommended from W24 to W40.

Resumption of antiretroviral therapy :

From W24 to W40 : During this 16 weeks period, in case of a decline of CD4 cell counts below 250 cells/mm3 or of a loss of CD4 greater than 50% of the baseline value, HAART will be restarted.

From W40 to W48 : HAART should be reintroduced if HIV-1 RNA levels \> 50 000 cp/ml on 2 consecutive measurements at two weeks interval even if the CD4 counts are above 250 cells/mm3.

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection
* under potent antiretroviral therapy for more than 6 months
* with entry CD4+ counts \> 350 cells/mm3 for at least 1 year
* plasma HIV RNA \< 400 cp/ml for at least the last 6 months
* Contraception needed for women

Exclusion Criteria:

* Antiretroviral therapy started with CD4 cell count \> 400/mm3
* Patients treated at time of primary HIV infection
* Patient with past AIDS defining event
Acute Effects of R- and S-MDMA in Healthy Subjects

Racemic ±3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. These acute subjective effects of MDMA may be helpful to assist psychotherapy and MDMA is currently investigated in phase 3 trials as a possible treatment in post-traumatic stress disorder.

MDMA is a racemic substance containing equal amounts of the enantiomers S(+)- and R(-)-MDMA. Preclinical research indicates that S-MDMA mainly releases dopamine, norepinephrine, serotonin, and oxytocin while R-MDMA may act more directly on 5-HT2A receptors and release prolactin. Animal studies also indicate that the two enantiomers act synergistically to produce the subjective effects of MDMA and that S-MDMA is mainly responsible for psychostimulation while R-MDMA may have fewer adverse effects and have greater prosocial effects. However, acute effects of S- and R-MDMA have never been validly examined in a human study. Therefore, the present study compares acute responses to R-MDMA, S-MDMA, MDMA, and placebo in a cross-over study in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years.
2. Understanding of the German language.
3. Understanding the procedures and the risks that are associated with the study.
4. Participants must be willing to adhere to the protocol and sign the consent form.
5. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
6. Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
7. Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
8. Willing to use double-barrier birth control throughout study participation.
9. Body mass index between 18-29 kg/m2.

Exclusion Criteria:

1. Chronic or acute medical condition
2. Current or previous major psychiatric disorder
3. Psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain.
4. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
5. Illicit substance use (not including cannabis) more than 20 times or any time within the previous month
6. Pregnant or nursing women.
7. Participation in another clinical trial (currently or within the last 30 days).
8. Use of medications that may interfere with the effects of the study medications.
9. Tobacco smoking (\>10 cigarettes/day).
10. Consumption of alcoholic drinks (\>15 drinks/week).
Capturing Parkinson's Disease Medication Side Effects During Daily Activities

The purpose of the study is to test whether body-worn wireless motion sensors can measure dyskinesias (involuntary movements caused by medications) in individuals with Parkinson disease (PD) independent of voluntary activity being performed and other PD motor symptoms (e.g. tremor).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of probable or definite idiopathic Parkinson Disease with motor fluctuations that include dyskinesias after taking their usual dose of levodopa/carbidopa

Exclusion Criteria:

* Antipsychotic medications (including quetiapine and clozapine)
* Coexisting neurologic disease such as stroke or dementia
* Lacking capacity for informed consent
* Residing in a nursing home
* comorbid non-neurologic illnesses that impacts the ability to perform the study tasks
* Implantable defibrillators
Development and Psychometric Testing of HPV Knowledge Scale

The aim of this study is to develop and conduct psychometric testing of a new scale, the Human Papillomavirus Knowledge Scale (HPV-KS), particularly designed to assess HPV knowledge among parents of school-age children in Indonesia.

research process after obtaining school principal. because the target population was parents who have daughters in elementary schools.

All participants (parents) were recruited from 5 elementary schools. According to a minimum sample size estimation for a psychometric study, it needs 10 times the total number of items (Boateng, 2018). the total participants, 52 items x 10= 520 participants were required.

The researchers got approval from schools to invite parents to attend the school of event invitations. Each participant came to the school where their child attended. Parents attended the regular meeting on the appointed day. at that time, researchers approached potential participants to explain to them the purpose of this study, participant rights, risks, and benefits. The researcher obtained participants' consent to participate in this research with a serial number.

During the process, researchers keep the participant anonymous. The questionnaires were distributed to the participants and took around 15-20 minutes to complete. All data was recapitulated and stored in Excel format. Data were kept by the researcher to maintain confidentiality. All data analyses were performed using SPSS software from IBM Corp.

Statistical analyses are below:

1. Descriptive analysis was used to identify population characteristics
2. Validity testing contains Exploratory and Confirmatory factor analyses were structure and construct.
3. Reliability testing was done using Cronbach alpha to determine the instrument's reliability.

Eligibility Criteria:
Inclusion Criteria:

* Participants have a child in elementary school
* Participants could speak Bahasa Indonesia fluently
* Participants live with their children in one house
* Participants are willing to participate in the study

Exclusion Criteria:

* parents had mental, visual, and hearing impairments or problems diagnosed by doctors
* their children' age are over 14 years old.
Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus

Tinnitus is a phantom auditory perception of meaningless sound, meaning that there is registration of sound in the absence of an external or internal acoustic stimulus. It is a common problem (prevalence 7-19%) which may interfere with the ability to lead a normal life. Unfortunately, it is a very difficult symptom to treat because there are hardly any therapeutic options for the cause of tinnitus. Most therapies focus on alleviating the condition rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Repetitive Transcranial magnetic stimulation (rTMS) is a therapy, based on this concept of reorganization in the auditory cortex. It uses a pulsed magnetic field to disrupt the neural circuit and to thereby (temporarily) excite or inhibit certain brain areas, leading to the suppression of tinnitus.


Eligibility Criteria:
Inclusion Criteria:

* Chronic, non fluctuating, tinnitus, demonstrated by means of the diagnostic Protocol Tinnitus UMCU, of at least two months duration.
* Age ≥18 years
* Dutch speaking

Exclusion Criteria:

* Treatable cause of the tinnitus
* Use of anticonvulsant medication or other psychotherapeutic drugs
* History of epilepsy or family members with epilepsy
* Presence of active migraine
* Presence of psychiatric, severe internal or heart diseases or other neurologic diseases besides epilepsy
* Metal objects in and around body that can not be removed
* Pregnancy (will be tested on the first day of rTMS using a urine pregnancy test)
* Alcohol or drug abuse
* Prior treatment with TMS
Cardiac Output Measurement at the Conclusion of Cardiopulmonary Bypass

Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in pediatric patients undergoing surgery involving cardiopulmonary bypass (CPB). Cardiac output will be measured after cardiopulmonary bypass using a device that employs ultrasound dilution technology. At times, cardiac output will be measured during a procedure called modified ultrafiltration (MUF). The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using other FDA approved techniques and devices.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (age \< 21 years)
* Pediatric patients undergoing surgery involving cardiopulmonary bypass

Exclusion Criteria:

* Patients aged \> 21 years
* Patients undergoing surgery "off pump" (not involving cardiopulmonary bypass)
Assessment of Long-term Impact Post COVID-19 for Patients and Health Care Professionals of the European Hospital

The purpose of the study is to Assess of Long-term impact post COVID for patients and health care professionals.The patients and medical staff will be followed for 2 years in order to provide clinical and paraclinical data not yet published in the literature.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years,
* Symptomatic COVID-19 infection confirmed (by RT-PCR or ELISA serology) or probable (CT criteria),
* Having given free and informed written consent,
* Being affiliated with or benefiting from a social security scheme.
* Patients / caregivers may be included in several ancillary studies at the same time.

Exclusion Criteria:

-Subject to a measure for the protection of justice