cyrilzakka/clinical-trials huggingface dataset:
Descriptive Study in Patients Treated With Vimovo™, Including Registration of the Physicians' Prescribing Patterns

The most common pain-relievers used by patients with rheumatic disorders are called non-steroidal anti-inflammatory drugs (NSAIDs). These drugs are effective and well documented, but they can cause ulcers and gastrointestinal side effects. Vimovo™ is a tablet containing naproxen (NSAID) and a gastroprotective agent called esomeprazole. Patients with rheumatic disorders, who are at risk for developing gastrointestinal side effects, and where lower doses of naproxen or other NSAID treatment is not considered sufficient, could use this tablet. The regulatory authorities in many European countries have approved the use of Vimovo™, but they would like to understand how various factors influence the doctors' decision to prescribe the tablet and what is characterizing the patients receiving it. The aim of the study is to answer these questions.

European study in patients with osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis at gastrointestinal risk: A retrospective, non-interventional study of Vimovo™ prescribing patterns

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis) Risk for developing gastrointestinal ulcer Already prescribed Vimovo

Exclusion Criteria:

* Participation in any interventional drug study at the time Vimovo™ was prescribed
* Patients started on Vimovo during the first 3 months after country-specific launch date
* Patients started on Vimovo after the study site is initiated (in order to avoid influence on prescribing decision and recruitment)
Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising oral doses and multiple oral doses of TR-701

This is an evaluation of TR-701 in a double-blind, placebo-controlled, randomized, single (Part A) and multiple (Part B) ascending dose safety, tolerance, and PK when administered as a capsule in normal, healthy adult volunteers. The study will be sequential between Part A and Part B (i.e., not staggered or leap frogged), with slight overlap between last cohort in Part A and first cohort in Part B.

Eligibility Criteria:
Inclusion Criteria:

* in good health
* body mass index of 20 to 29.9 kg/m2
* female subjects must be either postmenopausal for at least 1 year, surgically sterile, abstinent, or agree to use an effective method of birth control

Exclusion Criteria:

* history or clinical manifestations of any clinically significant disorder
* history of hypersensitivity or allergies to any drug compound
* history of stomach or intestinal surgery or resection
* history of alcoholism or drug addiction within 1 year
* use of any tobacco-containing or nicotine-containing products within 6 months
* use of any other medications
* use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages; or foods or beverages with high levels of tyramine
* pregnancy, lactation, or breastfeeding
Psychological Intervention for Parent-child Relationship and Couple Relationship Under COVID-19 in China

Under the COVID-19, individuals who were home Quarantine experienced new challenges on their parent-child relationship and couple relationship. The current project aimed to provide psychological interventions for both parents and couples in order to improving their relationship. The online intervention of group intervention and individual intervention are going to be conducted. The relationship between parent-child, couples and emotion regulation will be tested.


Eligibility Criteria:
Inclusion Criteria:

1. Parents of students in primary and secondary school.
2. Parents must had primary school education or above.

Exclusion Criteria:

1. Parents cannot speak or read Chinese.
2. Parents have severe mental or physical illness.
Biocompatible Versus Non-coated Extracorporeal Circuits in Cardiac Surgery

The aim of the present strudy is to investigate whether the use of biocompatible extracorporeal circulation circuits with a special hydrophilic polymer coating without heparin causes a reduction in the activation of the coagulation mechanism and the formation of microthrombi in the circuit tubing. A total of 50 patients undergoing cardiac surgery with extracorporeal circulation will be randomized in two groups using a computer-generated algorithm. The first group (study group) will undergo cardiac surgery with a specialized biocompatible circuit with a hydrophilic coating, while the control group will be operated with the conventional non-coated extracorporeal circulation circuit. During the period of extracorporeal circulation, blood samples will be taken at predetermined times which will be analyzed with the ELISA technique to determine the levels of prothrombin fragments 1+2 (F1+2), thrombin/antithrombin complex (TAT) as well as platelet factor P-selectin. Moreover, sections of the circuit tubes will be examined under electron microscopy for quantitative evaluation of microthrombi detected on the walls. The expected outcome of the study is to establish, with the use of specific biochemical markers and electron microscopy the protective effect of biocompatible coated extracorporeal circulation circuits on the coagulation mechanism and platelet activation.


Eligibility Criteria:
Inclusion Criteria:

* Planned surgery

Exclusion Criteria:

* Need for emergency surgery
* Serious hematological condition causing anemia, thrombocytopenia, etc.
* Receiving immunosuppressive treatment
* Inability to obtain consent
Onnit Labs New Mood Supplementation in Healthy College Students

The primary purpose of this study is to assess the effectiveness of ONNIT Lab's New Mood™ dietary supplement in supporting optimal mood balance and reducing daily stress among collegiate-aged men and women. To be considered for this study, the participant must meet the following criteria: (1) current undergraduate student at the University of Idaho between 18-24 years of age, (2) have no known allergies to the ingredients of New Mood™ (Niacin, Vitamin B6, Magnesium, Valerian Extract, Lemon Balm Extract, L-Tryptophan. 5-Hydroxytryptophan, and Inositol) or the placebo (rice bran and maltodextrin), (3) not currently taking any mood/sleep supplementation or medications, (4) not currently seeking therapy or diagnosed with a psychological disorder, (5) not regularly using cigarettes, marijuana, or other illicit drugs, and (6) not pregnant or breastfeeding.


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled collegiate men and women at the University of Idaho

Exclusion Criteria:

* Currently taking mood or sleep enhancing supplementation/medication
* Currently participating in counseling and/or therapy sessions
* Previously diagnosed with a psychological disorder
A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.

This 3 arm study will determine the dose of R1507 which will achieve a mean drug exposure in children and adolescents with advanced solid tumors equivalent to the exposure achieved in adults at the recommended dose of 9mg/kg/week. It will also determine the maximum tolerated dose (if appropriate) and the pharmacokinetic profile of R1507. Groups of patients will be sequentially enrolled in one of up to 3 dose levels (3,9mg/kg or a PK-derived dose, not to exceed 16 mg/kg) of R1507 administered weekly by intravenous infusion.An expanded cohort of patients will be enrolled at the optimal dose/MTD. The anticipated time on study treatment is until disease progression or dose limiting toxicity, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients aged 2-17 years of age;
* histologically confirmed solid tumors;
* cancer which has relapsed after, or failed to respond to, curative therapy, or no other potentially curative treatment options available.

Exclusion Criteria:

* treatment with corticosteroids within past 2 weeks;
* current or past use of anti-IGF-1R antibodies;
* current treatment with immunosuppressive agents;
* patients with diabetes mellitus;
* known HIV or hepatitis B or C;
* hypersensitivity to any of the components of R1507 or to monoclonal antibodies.
A Study to Assess the Long-term Safety and Tolerability of TMC114/Rtv in HIV-1 Infected Participants After Rolling-over From Other TMC114 Trials

The purpose of this study was primarily to assess the long-term safety and tolerability of TMC114/rtv in addition to an individually optimized background antiretroviral therapy in HIV-1 infected participants. In addition, antiviral activity and immunological effect were also evaluated.

This was a phase II, open label, multicenter trial of an investigational protease inhibitor TMC114 in the presence of ritonavir (rtv) in HIV-1 infected participants who were randomized in trials TMC114-C201, TMC114-C207 or in sponsor selected phase I trials and who might derive benefit from TMC114 therapy, as judged by the investigator.

The trial consisted of a screening period of a maximum of 4 weeks, a 96-week treatment period and a 4-week follow-up period. The maximal trial duration for each participant was104 weeks. During the treatment period, all participants were receiving TMC114 in combination with RTV, orally, as 600/100 mg dose twice daily, in addition to an individually optimized background regimen of antiretroviral (ARV) therapy, selected by the investigator at a baseline of the study.

Sponsor provided a follow-up treatment with TMC114 for all participants who continued to benefit from treatment with TMC114/RTV until it became commercially available for the participant. Participants, who completed the 96 weeks of treatment period with TMC114, had the opportunity to roll over to the extension of this trial, if TMC114 was not locally commercially available.

Eligibility Criteria:
Inclusion Criteria

* Must be diagnosed with HIV
* Previously randomized in trials TMC114-C201, TMC114-C207 or in sponsor selected Phase I trials
* Agreed to take at least 2 antiretroviral agents from baseline onwards
* Could comply with the protocol requirements
* General medical condition, in the investigator's opinion, was not interfering with the assessments and the conduct of the trial

Exclusion Criteria:

* A disallowed concomitant therapy
* Current or past history of active alcohol and/or drug use
* Pregnant or breast-feeding females
* Any active or unstable medical condition (e.g., tuberculosis; cardiac dysfunction; pancreatitis; acute viral infections)
* Clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis
* Clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication
* Laboratory abnormalities at screening (criteria variable according to the test)
ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02)

A Global Phase 2 Study to Evaluate the Efficacy and Safety of ARX788 for Selected HER2-mutated or HER2-amplified/overexpressed Solid Tumors (ACE-Pan tumor-02)

The study will enroll subjects with HER2-mutated or HER2-amplified/overexpressed locally advanced or metastatic solid tumor cancers whose prior standard of care therapies have failed. This basket trial will evaluate ARX788 across multiple cancer populations, as defined by HER2 genetic biomarkers

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and older
* Life expectancy \> 3 months
* Eastern Cooperative Oncology Performance Status ≤ 1
* HER2 status must be determined from a local Clinical Laboratory Improvement Amendments (CLIA) or equivalent-certified laboratory.
* Cohort 1, Cohort 2, and Explanatory Cohort A: HER2 mutated subjects with pre-specified HER2 activating mutation. Subjects with HER2 mutations in NSCLC (Cohort 1), breast cancer (Cohort 2), and other solid tumors (Cohort A) who have not received prior HER2 antibody drug conjugate (ADC) treatment are eligible.
* Cohort 3: Subjects with HER2 amplifications in biliary tract cancers (BTC) who have not received prior HER2 ADC treatment are eligible.
* Cohort 4: Subjects with HER2 amplifications in colorectal cancer (CRC), ovarian, endometrial, NSCLC and other solid tumors who have not received prior HER2 ADC treatment are eligible.
* Cohort 5 HER2 mutation or HER2 amplification: subjects with HER2 mutated or amplified tumors and have been previously treated with HER2 ADC are eligible.
* Subjects who are resistant or refractory to previous standard care of treatment.
* Subjects with stable brain metastases.
* Adequate organ functions.

Exclusion Criteria:

Any subject who meets any of the following criteria is excluded from the study:

* For Cohort 4: breast and gastric/GEJ cancer are excluded.
* Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease within 12 months.
* History of ocular events, any current ongoing active ocular infections, or any chronic corneal disease unless approved by Medical Monitor.
* Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of ARX788.
* Clinically significant surgical intervention (excluding diagnostic biopsy) within 21 days of the first dose of ARX788.
* Radiotherapy administered less than 21 days prior to the first dose of ARX788, or localized palliative radiotherapy administered less than 7 days prior to the first dose of ARX788, or radiotherapy-induced toxicity of Grade 2 or greater based on NCI-CTCAE v 5.0.

There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
Phase II Study of Intraventricular Methotrexate in Children With Recurrent or Progressive Malignant Brain Tumors

The purpose of this research study is to test an experimental treatment method for recurrent or progressive brain tumors in children aged from 0-22 years. The use of methotrexate and chemotherapy (topotecan and cyclophosphamide) is experimental in this study. This means that their use by themselves or together has not been approved by the U.S. Food and Drug Administration for this usage.

The purpose of this research study is to test an experimental treatment method for recurrent or progressive brain tumors in children aged from 0-22 years. The use of methotrexate and chemotherapy (topotecan and cyclophosphamide) is experimental in this study. This means that their use by themselves or together has not been approved by the U.S. Food and Drug Administration for this usage. This study will attempt to determine via serial MRI scans if methotrexate administration into the lateral or fourth ventricle in combination with systemic intravenous topotecan and cyclophosphamide is effective in reducing tumor burden in the brain and spine for patients with recurrent or progressive brain tumors, including medulloblastoma, ependymoma, PNET (Primitive Neuroectodermal Tumor), atypical teratoid/rhabdoid tumor (AT/RT), and other malignant embryonal tumors. In addition, the study will evaluate the toxicity of the above mentioned experimental treatment during a two-year progression-free survival and survival of children with recurrent malignant brain tumors.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent or progressive supratentorial or posterior fossa tumors with measurable disease on imaging studies of the brain and spine or CSF cytology.
* Tumor histology, including: Medulloblastoma , PNET, or other embryonal tumor, Atypical teratoid/rhaboid tumor (AT/RT), and Ependymoma.
* Leptomeningeal dissemination of a previously diagnosed CNS tumor.
* Diagnosis of tumor pathology will be based upon pathology diagnosis from previous surgeries for patients with recurrent tumors.
* Patients must have received prior radiation before current recurrence, unless the patient is less than 36 months old at diagnosis and has progressed after at least one upfront chemotherapy regimen in which case no prior radiation is required.
* Patients must have a life expectancy of at least 12 weeks as indicated by the patient's oncologist and/or neurosurgeon.
* Lansky or Karnofsky Performance status of at least 50.
* Negative pregnancy test.
* Specific organ function requirements for: Central Nervous System, Bone Marrow, renal and liver.

Exclusion Criteria:

* Patients that do not meet the inclusion criteria above.
* Pregnant or lactating female patients.
* Patients currently enrolled in another experimental treatment protocol.
* Patients with documented allergies to any of the chemotherapy agents used in this study.
* Patient/Parent refuses study participation.
* Patient is severely somnolent or comatose.
* Unable or unwilling to commit to return or to follow-up visits.
Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease

The study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in late-stage Parkinson's disease. The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.

The LeLeDys study is designed to determine the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in advanced Parkinson's disease.

The design is a multicenter, randomized, stratified, double-blinded, placebo-controlled phase IV study design.

The hypothesis is that levetiracetam is able to reduce duration and severity of levodopa-induced dyskinesias in Parkinson's disease.

The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.

Main inclusion criteria are:

* Advanced Parkinson's disease (Hoehn \& Yahr II-IV)
* Age of 30 to 80 years
* Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability
* Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion
* Written informed consent

Main exclusion criteria are:

* Atypical parkinsonian syndromes
* Treatment with antipsychotics
* Epilepsia or seizure in the history
* Deep brain stimulation other than DBS in STN
* Pregnant or lactating women
* Severe dementia

Methods:

* Primary outcome measure is the modified AIMS
* Secondary outcome measures include UPDRS, safety, patient day record

Study medication:

* Levetiracetam (upt to 2000 mg / day)
* Matched Placebo

Eligibility Criteria:
Inclusion Criteria:

* Advanced Parkinson's disease (Hoehn \& Yahr II-IV)
* Age of 30 to 80 years
* Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability
* Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion
* Written informed consent

Exclusion Criteria:

* Atypical parkinsonian syndromes
* Treatment with antipsychotics
* Epilepsia or seizure in the history
* Deep brain stimulation other than DBS in STN
* Pregnant or lactating women
* Severe dementia
KT vs IASTM on Upper Trapezius Myofascial Trigger Points To Compare Effect of KT VS IASTM on Pain Intensity, Pain Pressure Threshold, Cervical Range of Motion and Functional Disability Level.

This study would answer the following question: Is there a difference in the effects between IASTM and KT on pain intensity level, pain pressure threshold, cervical range of motion (ROM), functional disability level and satisfaction level in subjects with upper trapezius myofascial trigger points?

The aims of this study are:

1. To investigate the effect of KT and IASTM on pain intensity level in subjects with upper trapezius myofascial trigger points.
2. To investigate the effects of KT and IASTM on pain pressure threshold in subjects with upper trapezius myofascial trigger points.
3. To investigate the effects of KT and IASTM on cervical range of motion (ROM) in subjects with myofascial trigger points.
4. To investigate the effect of KT and IASTM on functional disability level in subjects with upper trapezius myofascial trigger points.
5. To investigate the effects of KT and IASTM on satisfaction level in subjects with myofascial trigger points.


Eligibility Criteria:
Inclusion Criteria:

- 1) Fifty subjects with age ranged from 18 to 23 years old (Formen et al., 2014).

2) From both genders with normal BMI ranges between 18.5:24.9 kg/m2. Had MTrPs of unilateral UT muscle (Shamseldeen et al., 2023).

Exclusion Criteria:

* 1. History of whiplash injury (Emshi et al., 2021). 2. History of head, neck, cervical spine or shoulder surgery (Emshi., et al 2021) 3. History of cervical radiculopathy (Emshi et al., 2021) 4. Patients with malignancy (Shamseldeen et al., 2023). 5. Cervical spine fractures (Shamseldeen et al., 2023). 6. Myelopathy (Shamseldeen et al., 2023). 7. Having undergone physical therapy within the past three months before the study.

  8. Non - rheumatologic diseases as multiple sclerosis, thyroid dysfunction and chronic infection.

  9. Rheumatologic condition as poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases.

  10. Presence of skin diseases (Luz Júnior et al., 2015). 11. Pregnancy (Luz Júnior et al., 2015).
Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.

The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.


Eligibility Criteria:
Inclusion Criteria:

* Advanced liver cancer
* Prior systemic treatment with sorafenib for advanced HCC and for whom their disease progressed during or after sorafenib treatment, or were intolerant to sorafenib treatment. Specifically, this can be defined as:

  * Documented radiological confirmation (radiology scans or report) of disease progression during or after sorafenib treatment
  * Intolerance to sorafenib (at any dose and/or duration) is defined as documented sorafenib-related grade 3 or 4 adverse events that led to sorafenib discontinuation.

NOTE:

* Sorafenib must be the last antineoplastic treatment before randomization
* Prior local and/or hormonal therapy (e.g., tamoxifen) before sorafenib is allowed
* One systemic chemotherapy regimen for advanced HCC is allowed before sorafenib treatment

  * ECOG performance status of ≤ 2
  * Child-Pugh A

Exclusion Criteria:

* Active bleeding during the last 28 days
* Prior therapy with mTOR inhibitors
* Prior liver or other organ transplantation which mandates systemic immunosuppression

Other protocol-defined inclusion/exclusion criteria may apply