cyrilzakka/clinical-trials huggingface dataset:
Biomarker Monitoring of Prostate Cancer Patients With RSI MRI (ProsRSI)

Adult male patients with high-risk, localized prostate cancer and planning to undergo radiation therapy (RT) with androgen deprivation therapy (ADT) will undergo an advanced Magnetic Resonance Imaging (MRI) examination called Restriction Spectrum Imaging (RSI-MRI) to evaluate whether RSI-MRI can predict treatment response.

Participants will undergo RSI at three time points: before therapy (MRI #1), after neoadjuvant ADT (MRI #2), and after radiotherapy (MRI #3). Treatment response will be assessed primarily by absence of biochemical recurrence (PSA ≥2 ng/mL greater than nadir) within 3 years of completing radiotherapy. Change in RSI cellularity index from MRI #1 to MRI #2 will be evaluated for prediction of participants who will experience biochemical recurrence within 3 years, using area under the receiver operating characteristic curve. We hypothesize that RSI cellularity index will be an early biomarker for treatment effectiveness in prostate cancer treated with ADT and radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Male, aged ≥18 years, with histologically confirmed adenocarcinoma of the prostate
* High-risk prostate cancer (any of: PSA ≥20 ng/mL or cT3-T4 stage or Gleason score ≥8)
* Intended treatment and follow-up according to standard of care for prostate cancer
* Planning to undergo definitive radiotherapy with neoadjuvant and concurrent androgen deprivation therapy
* In good general health as evidenced by medical history and ECOG performance status 0-2
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Prior radiotherapy to the pelvis
* Prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy)
* Hip prosthesis
* Contraindication to MRI, per institutional requirements
* Technetium-99 bone scan showing no clear evidence of distant metastasis
* MRI or CT scan of the pelvis showing no clear evidence of bone or distant metastasis
* Another malignancy, unless in remission or unlikely to impact the patient's survival or ability to receive standard care for prostate cancer (e.g., cutaneous basal cell carcinoma)
* Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
The Effectiveness of Rehabilitation Training Based on Brain-computer Interface Technology to Improve the Upper Limb Motor Function of Ischemic Stroke.

To evaluate the effectiveness and safety of rehabilitation training based on brain-computer interface in improving the upper motor function, self-care ability in daily life and quality of life in patients with ischemic stroke. This study adopts centralized uniform random 1:1 grouping, subjects will be randomly assigned to the experimental group and the control group. Randomization schemes are generated by statistical professionals using SAS software.

Brain computer interface(BCI) is a noninvasive nervous system intervention. As a new method, it is applied in rehabilitation by stimulating peripheral nerve, such as motor, vibration, sensory, in combination with other stimulations, such as transcranial magnetic stimulation, transcranial electrical stimulation, etc.

In traditional rehabilitation therapy, hand-holding training is completed by physical therapist. Rehabilitation robot is also used for auxiliary training. BCI therapy will stimulate patients to take part in rehabilitation training more actively and obtain better effects on the rehabilitation of stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects (18 years\<male or female≤80 years )
2. Ischemic stroke diagnosed by MRI within 1 month before randomization
3. Unilateral upper limb dysfunction with NIHSS score 1-3 at the time of randomization
4. Informed consent signed

Exclusion Criteria:

1. Unable to understand or cooperate because of severe aphasia or cognitive impairment (CDR \>0.5) or mental illness
2. A history of epilepsy
3. Sensory disorders or hallucinations
4. Internal carotid artery dissection or thrombolysis
5. Apraxia
6. Agnosia
7. Other diseases that may interfere with motor function
8. Severe cardiopulmonary disease, severe illness, and unstable vital signs
9. Severe balance dysfunction
10. Participating in other clinical trial
11. During pregnancy and lactation
12. The Numerical Rating Scale (NRS) scores of upper extremities\>4.
Acupuncture in Fibromyalgia

Fibromyalgia is the second most common rheumatic disorder, affecting approximately 8-10 million persons in the U.S., and is characterized by widespread musculoskeletal pain and soft tissue tenderness upon examination. This study focuses on the use of acupuncture as a mode of therapy for fibromyalgia. The issues under examination are: 1) the optimal duration of treatment, 2) the independent and synergistic effects of needle placement and needle stimulation, and 3) appropriate control strategies. The proposal utilizes a randomized, blinded, sham-controlled design to achieve these aims. Subjects are randomly assigned to one of four groups: 1)active site with stimulation, 2) active site, without stimulation, 3) sham site with stimulation, and 4) sham site, without stimulation. All subjects will receive acupuncture at escalating frequency, beginning at once per week and ending at 3 times per week. This "forced titration" design allows for the detection of inter-subject differences in responsiveness to acupuncture, as well as the factors which may predict responsiveness (or lack thereof). Secondary goals of the study are to collect data on the mechanism, safety, and cost-effectiveness of acupuncture in fibromyalgia, and to determine the optimal outcome measures, for a full scale research clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Must be a resident of the Washington DC area.
* Having met ACR criteria for fibromyalgia.
* Continued widespread pain for more than 50% of days.
* Willing to limit the introduction of any new medications or treatment modalities for control of fibromyalgia symptoms during the 13 weeks of active treatment.
* Able to travel to acupuncture site up to 3 times per week.
* Capable of giving informed consent.

Exclusion Criteria:

* Knowledge of acupuncture sufficient to prevent "blinding" of the subject.
* Presence of a known coagulation abnormality that would prevent safe use of acupuncture.
* Presence of a concurrent autoimmune or inflammatory disease that causes pain.
* Routine daily use of narcotic analgesics or history of substance abuse.
* Participation in other concurrent therapeutic trials.
* Pregnant or nursing mothers.
* Disability insurance payments.
* Ongoing litigation related to fibromyalgia.
* Contraindication for the use of acetaminophen or ibuprofen.
* Any impairment, activity, or situation that in the judgement of the Study Coordinator would prevent satisfactory completion of the study protocol.
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)

This LTFU is being conducted to assess long-term safety and durability of response in participants dosed with IP in a parent protocol, and to collect longitudinal natural history in enrolled but not dosed participants who also participated in a parent protocol.

This is a 14.5 year LTFU protocol to assess long term safety and clinical response to IP as well as to capture natural disease history of participants not dosed with IP in a parent protocol. No IP is provided as part of this protocol. Participants will remain on standard of care medication as indicated and prescribed by their physicians.

Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in an iECURE parent protocol and have either completed or discontinued that protocol
2. Participant parent(s)/LAR is willing and able to adhere to the protocol requirements.
3. Consent was obtained by the participants parent(s)/LAR (and participant assent, where applicable), prior to any study-related data being collected.

Exclusion Criteria:

1. Participants who enroll into an interventional drug or gene therapy clinical trial utilizing an IP other than the IP provided in the parent protocol will be excluded from this protocol.
Acute Effects of Vinyasa Yoga on Vascular Function

The purpose of this investigation was to determine the acute effects of vinyasa yoga on arterial stiffness, wave reflection, and blood markers in normo- and hyper-tensive adults. To address this aim, fifteen normotensive adults and 15 adults with elevated blood pressure or stage 1 hypertension with a minimum of 3 months of yoga practice experience were enrolled. Carotid-femoral pulse wave velocity (cf-PWV), augmentation index (AIx), lipid profile, and glucose concentrations were assessed at baseline and immediately following a 1-hour vinyasa yoga session.


Eligibility Criteria:
Inclusion Criteria:

* Having normal (systolic blood pressure \<120 mm Hg with a diastolic \<80 mm Hg) or elevated blood pressure (systolic blood pressure 120-129 mm Hg) or stage 1 hypertension (systolic blood pressure 130-139 mm Hg or a diastolic blood pressure 80-89 mm Hg).
* Must have had at least 3 months of prior yoga experience.

Exclusion Criteria:

* A history of cardiovascular disease or cardiac events, pregnancy, infection within the last 4 weeks, chronic obstructive pulmonary disease (COPD), endocrine or renal disease, metabolic disorders, or debilitating muscular, joint and bone injury.
Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)

The purpose of this study is to demonstrate the safety and efficacy of inhaled Iloprost (Ventavis®) among adult Chinese patients with primary pulmonary hypertension, which is in compliance with Chinese SFDA regulation.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female age 18-65 years old
* The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
* Patient with Primary Pulmonary Hypertension (i.e. IPAH or FPAH) and classified as NYHA functional class III
* Written informed/data protection consent
* No prior treatment with Ventavis or other active treatments for PPH within 6 weeks of date of study.

Exclusion Criteria:

* Known or newly identified contraindication for administration of Ventavis as stated in the Ventavis product package insert.
Persons With Obesity (PwO) Exploratory Research

The purpose of this study is to understand the personal flow along the weight loss management journey. A range of variables will be addressed in a survey to explore the weight loss journey, barriers and management. Topics include weight loss strategies and challenges, HCP involvement, and perceptions towards weight loss medications.

Potential participants will be recruited using various online panels. Study participants will be recruited to participate in 2 types of qualitative research.

Phase I: Online bulletin boards (OBB) Phase II: Virtual focus groups (real-time)


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal to 18 years at the time of signing informed consent.
3. Current body mass index (BMI) of 25 or greater
4. Not currently pregnant
5. Does not participate in intense fitness or body building program
6. Weight loss not through illness or injury
7. At least somewhat concerned about current weight
8. If no plans for weight loss in the next six months, has made at least 1 weight loss effort in last 5 years
9. Struggling with weight for at least 3 years

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Does not meet inclusion criteria.
Auto-acupressure: Effectiveness for Diminishing Neck Pain of Benign Origin

The purpose of this study is to evaluate the effectiveness of the auto-acupressure (digital pressure in points of acupuncture) added to the conventional treatment.

OBJECTIVE: To evaluate the effectiveness of the digital pressure in points of acupuncture added to the conventional treatment for diminishing the pain in patients with cervicalgia of benign origin.

MATERIAL AND METHODS: Pragmatic controlled randomized clinical trial. Patients with diagnosis of cervicalgia of benign origin will include. They will be randomly assigned to receive just conventional treatment or this plus auto-acupressure.

The professionals will once receive instruction in the Centres of Health by an experienced acupuncture professional that will supervise, in a workshop, the right application of the technique, that will consist of the application of manoeuvres of auto-acupressure by the own patient during periods of 10 minutes, once in a day during one week. The pain intensity will be evaluated by means of a millimetric scale of 10 cm (0 represents the pain absence, 10 the maximum imaginable pain, Numerical Scale Rating). The pain will be measured in the inclusion and days 1, 3, 7, 30 and 90. The sample size has been calculated to detect a minimum difference of 1.5 points (DS 2) in the scale of the pain in day 7, which implies the recruitment of, at least, 80 patients by group (if losses don't exceed 20%). Also the perception of the quality of life (euroQol-5D) and the functional capacity with the scale of Oswestry will be evaluated, at the beginning, and days 3, 7, 30 and 90. The measures in each point between the group will be compared control and intervention. The evolution of the repeated measures will compare between groups with a generalized estimating equation (GEE) model.

Eligibility Criteria:
Inclusion Criteria:

* Patients who come to consultation of Primary Care for neck pain without structural hurt or irradiation, with muscular contraction and functional and postural limitation.

Exclusion Criteria:

* Injuries of skin (dermatitis, burns, sores, skin cancer) in the zone to massaging
* Structural injuries (bony fractures or injuries of muscles and tendons) in the zone to massaging
* Hemorrhage or tendency to suffer hemorrhage
* Chronic, serious diseases
* Malignant diseases and marked physical deterioration
* Psychiatric disorders
* Sensitive alterations
* Treatment with drugs of second or third level of the scale of the WHO which difficult to estimate changes for auto-acupressure
* No sign the informed consent
* Difficulty of reading comprehension or visual alterations
Healthy Futures Evaluation

This study evaluated the impact of the three-year Healthy Futures program on teen sexual behaviors in three Massachusetts cities.

This study evaluated the impact of the three-year Healthy Futures program on teen sexual behaviors in three Massachusetts cities. This longitudinal school-cluster randomized controlled trial included 15 public middle schools (n=1,344). Participants were enrolled in the 6th grade in the 2011-2012 school year (Cohort 1) or 2012-2013 school year (Cohort 2). Outcome data sources included five student surveys: baseline; 6th, 7th, 8th grade follow-ups; and 9th grade follow-up (Cohort 1 only).

Eligibility Criteria:
Inclusion Criteria:

* Students attended one of the 15 participating public middle schools
* Students were enrolled in the 6th grade in the 2011-2012 school year (Cohort 1) or 2012-2013 school year (Cohort 2)
* Students were not withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study

Exclusion Criteria:

* Students were were not in the 6th grade at the time of consent
* Students were not in the school after the consent/assent process occurred
* Students were withdrawn from Healthy Futures program participation by himself/herself, a parent, or school administrator(s) prior to the consent/assent process for the study.
Drug Delivery and Toxicities of Adjuvant Chemotherapy in Resected NCSLC

There are limited numbers of retrospective studies showing the effectiveness of adjuvant chemotherapy over observation in resected lung cancers.

We propose to retrospectively examine the Washington University School of Medicine experience on all patients receiving adjuvant chemotherapy between 2003 and 2005. We will retrospectively analyze the survival and outcomes in the lung cancer patients receiving adjuvant chemotherapy following surgical resection.

Eligibility Criteria:
Inclusion Criteria:

* Patients that received adjuvant chemotherapy
* 18-88 years

Exclusion Criteria:

* Any patients that have not received adjuvant chemotherapy
* Patients under 18 or over 88
Digital Media Privacy Literacy Training

The purpose of this randomized controlled experimental study is to evaluate the effects of digital privacy literacy education on children's autonomy, decision-making and privacy awareness.The hypotheses of the study are as follows; H1a: Digital privacy literacy education has an effect on children's autonomy. H1b: Digital privacy literacy education has an effect on children's decision-making.

H1c: Digital privacy literacy education has an effect on children's privacy awareness.

The research will be conducted with 4th grade students (9-12 years old) who are receiving education in a primary school affiliated to Ağrı Provincial Directorate of National Education and who meet the inclusion criteria. Students will be divided into 2 groups as experimental and control groups by simple random method. Digital environment privacy literacy training will be provided to the experimental group, while no training will be provided to the control group. Data will be collected using "Child Information Form", "Autonomy Survey" and "Primary School Students' Privacy Consciousness Scale".

Eligibility Criteria:
Inclusion Criteria

* Being in the 4th grade of primary school
* Not being an inclusive student
* Parent's written consent to participate in the research
* Child's verbal consent to participate in the research

Exclusion Criteria

* Child/parent wants to leave the study at any stage
* Child does not attend the training sessions 2 or more times
* Child does not complete at least one of the pre-test and post-test data collection tools
Effect of Open-placebo Intervention on Cycling Performance

This study evaluates the effect of an open-label placebo intervention on cycling time-trial performance.

This study investigated the effect of open-placebo on cycling time-trial (TT) performance. Twenty-eight trained female cyclists completed a 1-km cycling TT following a control session or an open-placebo intervention. The intervention consisted of an individual presentation, provided by a medic, in which the concept of open-placebo was explained to the participant, before she ingested two red and white capsules containing flour; 15 min later, they performed the TT. In the control session, the participant sat quietly for 20 min.

Eligibility Criteria:
Inclusion Criteria:

* Females aged between 18 and 45 years old;
* A minimum of one-year training experience in cycling.

Exclusion Criteria:

* Smokers
* Chronic disease
* Prior or current use of steroids
* Use of creatine in the last 6 months
* Use of beta-alanine in the last 6 months
Trial of Autologous Mesenchymal Stem Cells in Patients With Multiple System Atrophy

This study is based on positive results in open label trial of mesenchymal stem cells therapy in patients with Multiple System Atrophy (MSA).


Eligibility Criteria:
Inclusion Criteria:

* 75 Years Old or Less
* Multiple System Atrophy
* Voluntary Participants

Exclusion Criteria:

* Doubted dementia (MMSE \< 24)
* Severe febrile condition
* Serum SGOT/SGPT three times above
* Malignant mass
Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED)

The purpose of this study is to access the efficacy and safety of Mizoribine 150mg qid and 50mg tid in active rheumatoid arthritis patients unsuccessfully treated with disease-modifying antirheumatic drug.

1. EULAR Response after 24weeks of treatment
2. EULAR Response after 12weeks of treatment
3. DAS28 value change
4. KHAQ-20 value change

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged from 20 to 80 years old
* Signed and dated informed consent document indicating that the patient
* Patients must have a diagnosis of Rheumatoid Arthritis(RA) of at least 3months duration as defined by the 2010 American College of Rheumatology(ACR) Classification criteria.
* Patients should have a Disease Activity Score 28 greater than or equal to 3.2 (DAS28 ≥ 3.2) and have received treatment with more than 1 kind of disease-modifying antirheumatic drug(including MTX).
* ESR≥28mm/h or CRP≥1.0mg/dl at screening.

Exclusion Criteria

* At screening, patients have laboratory result as defined by : white blood cell ≤ 3,000/mm3

  , Hemoglobin \< 8.5 g/dL, Platelet count \< 100,000/mm3, Serum creatinine \> 2.0 mg/dL, Aspartic Acid Transaminase/Alanine Transaminase ≥ 2\*upper limit of normal , Uric acid ≥ 1.5\*upper limit of normal
* Patient must not have bleeding disorder or taking anticoagulant. (But, lt is allowed to take 100mg/day of Asprin)
* Patients with a history of operation on index knee joint which could have influence on the result and need to have surgery as determined by investigator.
* Patients have severe infection, including moderate respiratory disease and have received treatment with systemic antibiotics within 2 weeks.
* Patients have cardiovascular disease or associated disease which is not controlled.
* Patients have a history of malignancy within 5years. (But, basal cell or squamous cell carcinoma or carcinoma in situ of the uterine cervix have been treated is allowed)
* Patients have hypersensitivity reaction on this drug.
* Patients on any other clinical trial or experimental treatment in the past 3months.
* Female patients who are breast feeding, pregnant or plan to become pregnant during the trial or for two months following study termination.
* Not allowable medication recorded below ; Intra-articular injections within weeks at baseline visit, Patients taking oral steroid over 10mg /day or using new treatment or changing dosage within 4weeks at baseline visit, Using new nonsteroidal antiinflammatory drug within 4 weeks or changing nonsteroidal antiinflammatory drug dosage within 2 weeks at baseline visit.
* Having experience of use biologic agent, immunosuppressant, cytostatic preparations within 8weeks at baseline visit. (But, Rituximab is not allowed within 6months)
* Start to treatment new disease-modifying antirheumatic drug or need to change dosage of disease-modifying antirheumatic drug which is taking on the trial. (Leflunomide(ARAVA®) is not allowed within 12weeks, But, Cholestyramine is allowed after 48 hours later stopping. if it use three times a day, 8g, for 11days)