cyrilzakka/clinical-trials huggingface dataset:
Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis

Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies, for the treatment of active psoriatic arthritis and to assess the changes in disease symptoms.

The therapies being assessed in this sub-study are risankizumab and lutikizumab. Participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: lutikizumab monotherapy, risankizumab monotherapy or a combination therapy of lutikizumab and risankizumab. Around 120 participants will be enrolled in the study at approximately 40 sites worldwide.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to comply with procedures required in the Master Protocol and substudies.
* Participant has a documented clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) at Screening Visit.
* Participant has active disease defined as greater than or equal to 3 tender joints (based on 68 joint count) and greater than or equal to 3 swollen joints (based on 66 joint count) at both the Screening Visit and Baseline.
* Participant has active plaque PsO and/or a documented history of plaque PsO.
* Participant must demonstrate intolerance or inadequate response to 1 to 2 targeted therapies (biologic or targeted synthetic disease-modifying antirheumatic drugs) approved for the treatment of PsA

Exclusion Criteria:

* Participants who have had major surgery performed within 12 weeks prior to randomization or plan to have a major surgery during conduct of the study (e.g., aneurysm removal, stomach ligation).
* Participants with the following chronic or active infections: Are infected with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus(HCV) infection, active tuberculosis(TB)
* Active skin disease other than psoriasis (PsO) which could interfere with the assessment of PsO.
* History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than psoriatic arthritis (PsA) (including but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).
Nonneoplastic Epithelial Disorders of Vulva and High Intensity Focused Ultrasound

Nonneoplastic epithelial disorders of skin and mucosa of vulva refer to a group of chronic diseases shown as female genital skin and mucosal tissue degeneration and pigmentation change. The main symptoms are vulval itching, squamous cell hyperplasia, vulval and perianal skin atrophy or thinning, hypopigmentation. The current treatments are primarily local drug or surgical treatments. However, the effect is not good enough, but the diseases often recur and severely affect patients' quality of life. In this study, the investigators combined the technology of high intensity focused ultrasound (HIFU) (ultrasound device made by Mianyang Sonic electronic LLC, Mianyang China, registration number: 2005-2230099} with special drug to treat. The data from colposcopy and biopsy pathology were collected before and after treatment to create the objective identifying degree of the disease by with "grading methods" and evaluate the treatment effect. At the meantime, the standardized treatment procedure, methods and efficacy criterion were all stipulated to achieve satisfactory results, which could be used to clinical treatments. So far, the investigators have not seen similar study reported internationally.


Eligibility Criteria:
Inclusion criteria:

* patients with clinically and biopsy confirmed non-neoplastic lesions of genital skin and mucous membrane (non-neoplasia epithelial disorders of skin and mucosa of vulva).

Symptoms include repeated itching, discoloration, rhagades, loss of skin elasticity and dyspareunia that affect the patients' quality of life.

Exclusion criteria:

* atypical hyperplasia or vulvar cancer confirmed by biopsy of genital lesions;
* vulvovaginal or other gynecological trauma, acute inflammatory diseases and other acute illness in need of urgent care;
* combined with other serious gynecological diseases (symptomatic hysteromyoma, ovarian tumor, etc.), and/or severe organ diseases (such as heart, lung, brain and renal disease/failure) that need immediate treatment;
* other type of cancers that require urgent care.
A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.

This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI).


Eligibility Criteria:
Inclusion Criteria:

* Men or women, at least 18 years of age, with evidence of myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI), in the last week.

Exclusion Criteria:

* Ongoing hemodynamic instability
* Evidence of hepatobiliary disease
* Evidence of chronic kidney disease (CKD) (Stage III, IV, or V), defined as moderate or severe renal impairment or if subject is receiving dialysis
* Evidence of unstable renal function
* History of acute kidney injury after previous exposure to an intravenous contrast agent.
* Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its components
* Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women

This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old

Exclusion Criteria:

* Use of estrogen or hormone replacement therapy
* Use of parathormone or parathormone fragments, calcitonin, aluminum supplements, within 12 months prior to first dose.
* Use of bisphosphonates and strontium ranelate
* Cancer or history of malignancy of any organ system
* Any radiation therapy to the skeleton.
* Any known clinically significant disease affecting calcium metabolism. Any history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia.
* History or clinical evidence of any impairment of thyroid function
* Other protocol-defined inclusion/exclusion criteria apply.
PsoVac: Educational Needs re Vaccines for Biologic Patients With Psoriasis

To determine if there is a need for further education on vaccines with psoriasis patients who are on a biologic. In regards to the COVID-19, it is important that psoriasis patients - whether on a biologic or not - understand whether they can have certain vaccines. That will depend on the type of vaccine that becomes available.


Eligibility Criteria:
Inclusion Criteria:

* psoriasis patient

Exclusion Criteria:

* no exclusions
Evaluation of Sleep Apnea and Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia

Higher risk of cardiac and respiratory post-operative events is observed in patients with unrecognised Obstructive Sleep Apnea (OSA). The efficiency of a simple method of OSA screening by analysing ventilation with measurement of nose pressure and nocturnal hypoxemia (oxygen desaturation index) will be assessed. These sleep respiratory analyses will be compared with the research of arrhythmia, in order to show if they are linked to the hypoxemia events.

Aggravation of nocturnal respiratory disorder and higher incidence of cardiac and respiratory postoperative complications will be assessed in OSA patients.


Eligibility Criteria:
Inclusion Criteria:

* orthopaedic, urologic, vascular, digestive surgery
* under general anaesthesia or sedation
* age \> 45 years old
* STOP-BANG score\>3

Exclusion Criteria:

* Head and neck surgery, planned prolonged mechanical ventilation after surgery (\>24h)
* Severe COPD
* Post-operative ICU planned
* Diagnosed OSA or other sleep disorder breathing
Influence of the Biological Maturation on the Antrhopometric Variables and Sport Performance in Volleyball Players

The project consists of a cross-sectional study in which anthropometric variables, general and specific performance variables of volleyball will be measured, and the biological maturity stage will be calculated. The main objective is to establish a relationship between the biological maturation state, the anthropometric characteristics and the performance in physical fitness tests in volleyball players between 12 and 15 years of age. To do this, there will be all the clubs in the Region of Murcia that have federated teams in these categories.


Eligibility Criteria:
Inclusion Criteria:

* To play volleyball in a regular basis
* To have between 12 and 15 years
* To participate in volleiball competitions with the team

Exclusion Criteria:

* To be injured in the moment of the measurement session
* To have skipped most of the training sessions the last month
* To have less than a year of experience playing volleyball
MRI-guided Lateral Lymph Node Dissection in Rectal Cancer

To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI

Our study design is a multicenter, prospective, registry study.

We would enroll 268 patients with lower rectal cancer whose preoperative MRI showed laterally lymph node diameter ≥ 5mm.

The postoperative adjuvant chemoradiotherapy is determined by the pathological results. For patients of stage II and patients of stage III with unfavorable histologic features, six months of adjuvant chemotherapy of fluorouracil-based regimen with radiotherapy of 45.0 \~ 50.5 Gy are recommended.

The postoperative examination should be performed every three months in the first two years and every six months in the following three years.

Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-75 years old
2. Pathologically confirmed as rectal adenocarcinoma
3. The tumor is located in the middle or lower rectum
4. Preoperative MRI assessment is T2-4 N+M0
5. Lateral lymph node short diameter ≥ 5 mm (MRI)
6. Signed informed consent

Exclusion Criteria:

1. Previous history of malignant colorectal tumors
2. Multiple abdominal or pelvic surgeries were performed
3. Complicated with bowel obstruction, perforation or bleeding
4. Patients undergoing palliative surgery
5. Patients with severe liver and kidney dysfunction, cardiopulmonary dysfunction, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery
6. Have a history of severe mental illness
7. Pregnant or breastfeeding women （8) Patients previously treated with iliac artery surgery (or its branches)

(9) R0 resection cannot complete (10) ASA grade ≥ IV
Passport to Freedom (P2F): Adaptation and Implementation of a Wellness Program

Women currently residing at an emergency shelter for women and children will participate in group sessions that cover topics that promote physical and emotional well-being through a combination of mindfulness exercises and health promotion activities..

In a group setting, the intervention will cover topics such as Mindfulness, Health (examine impact of trauma and stress on physical and mental well-being), Healthy relationships, Family matters (coping with conflicts) and Reflection session.

Each group session (5) will last approximately 90 minutes, once weekly, and begin and end with mindfulness exercises. The women are also encouraged to download free mindfulness apps to practice the exercises between sessions.

Women enrolled will receive health information that will cover a range of chronic health topics (pain, asthma, hypertension, diabetes, obesity), to complement already existing tools on mental health and post traumatic syndrome.

Women enrolled will complete surveys:

baseline questionnaires, a pre and post survey during each session, and follow-up questionnaires 4 weeks after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to read and write English
* Currently residing at the House of Ruth Maryland emergency shelter or onsite transitional housing.

Exclusion Criteria:

* Under 18 years of age
* Inability to speak or write English
* Physical or mental health conditions that would prevent meaningful group participation.
Smoking Cessation in Primary Health Care Patients With Obstructive Pulmonary Disease

The purpose of this study is to determine if an assessment protocol that measures the need for support with smoking cessation and that will be administered by primary health care nurses helps patients with obstructive pulmonary disease (COPD) quit smoking.

Some patients with COPD continue to smoke despite the importance of quitting. A specially developed assessment protocol for such patients may support nurses in their discussions with the patients about smoking cessation. In a previous qualitative study involving in-depth interviews with patients with COPD, the assessment protocol "Trying to quit smoking" (TTQ) was developed. The protocol consists of approximately 21 statements that the patient responds to on a scale ranging from 1 (agree entirely) to 4 (disagree). The purpose of the protocol is to identify areas in which the patient may need extra support in order to quit smoking.

The aim of this study is to validate the TTQ by testing it in a clinical setting. The study will be conducted at approximately 40 primary health care centers in Stockholm County. The nurses will identify 5 consecutive patients who have COPD and smoke. All nurses will complete a questionnaire for each patient at baseline (after visit 1) and after 3 months describing treatment provided. The nurses will ask each patient to fill in the TTQ and will provide individual counseling on the basis of the answers. After 3 months, the nurses will ask all patients if they still smoke and to fill in the TTQ again. Appropriate statistical methods will be used to analyze the questionnaire data.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of COPD
* Current smoker
* Speak Swedish well enough to answer the TTQ assessment protocol

Exclusion Criteria:

* Cognitive difficulties that, in the judgment of the participating nurses, would make it difficult for the patient to answer the TTQ assessment protocol or benefit from counseling
The Calgary Movement Disorders Advanced Care Pilot Program

The goal of this clinical trial is to analyse the effect of palliative care interventions on quality of life, patient satisfaction, carepartner burden and health care utilization patterns in patients living with parkisonism and their carepartners.

Participants will:

* Receive multidisciplinary palliative care.
* Answer questions related to the quality of life, patient satisfaction, carepartner burden and health care utilization patterns.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have a PD diagnosis or another PDRD diagnosis (multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, or Lewy body dementia)
* Participants who have moderate to high PC needs based on the Palliative Care Needs Assessment Tool (PC-NAT)
* Participants who are between 20 and 100 years old

Exclusion Criteria:

* Immediate and urgent palliative care needs. These patients will be offered appropriate services immediately
* Participants who have other illnesses that could require PC e.g. metastatic cancer
* Participants already receiving PC and/or hospice
* Patients with a diagnosis of severe cognitive impairment (Montreal Cognitive Assessment \<10). These patients will be offered appropriate services. Care partners can participate.
Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients

This was a retrospective real-world evidence cohort study.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of melanoma (The International Classification of Diseases, 9th Revision \[ICD-9\] 172.x \& 10th revision \[ICD-10\] C43 or D03x).
* Pathologic stage IV at initial diagnosis on or after 01 January 2011.
* First-line treatment with IO monotherapy or combination therapy (nivolumab, pembrolizumab, ipilimumab + nivolumab) or TT combination therapy (dabrafenib + trametinib, vemurafenib+cobimetinib, encorafenib+binimetinib) on or after 01 January 2014.
* Evidence of a BRAF test.
* Evidence of a BRAF-positive result prior to or up to 30 days after first-line (1L) therapy initiation.
* At least 18 years of age at the time of initiation of 1L treatment.

Exclusion criteria:

* Documented receipt of a clinical trial treatment for cancer at any time on or after 01 January 2014.
* Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment.
Using Probiotics to Improve Oral Hygiene During Orthodontic Treatment

Fifty patients needing non-extraction-based metallic orthodontic treatment will be divided randomly into the probiotic group and the control group. In each group, they will brush their teeth regularly while receiving orthodontic treatment. Only the probiotic group will take probiotic tablets for six months.

Clinical parameters will be assessed before and during orthodontic treatment and after 3 and 6 months during treatment.

Each subject will be examined completely to ensure eligibility before enrolling in the study. The operator will then inform them about the study's aim and ask them to provide written informed consent. Patients will receive professional scaling, polishing, and oral hygiene instruction before the research starts.

Regarding the probiotic, (PRODENTIS) is commercially available in Sweden and the USA. Probiotics prepared by Bio-Gaia AB (Stockholm, Sweden). Each probiotic tablet contains two strains of probiotic lactic acid bacteria of human origin: L. reuteri DSM 17938 and L. reuteri ATCC (PTA 5289), each at a minimum of 1 × 108 CFU per lozenge. The tablets should be stored at a temperature below 25 ◦C. Dosage instructions will be prescribed per the manufacturer's recommendations at a preventive dosage of 1 lozenge/day (after dinner and teeth brushing).

Regarding the clinical parameters, the Plaque index (Pl), the gingival index (GI), the Papillary Bleeding Index (PBI), 1977, and probing depth (PD) will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Adult healthy male and female patients aged 18-25 years.
2. Patients eligible for full arch upper and lower fixed labial orthodontic appliance treatment and molar band.
3. Patients with malocclusion class I, II, or III without crowding on the anterior teeth.
4. Permanent occlusion and existence of all the upper and lower teeth (except third molars).
5. Good oral and periodontal health:

   * Probing depth \< 4 mm
   * No radiographic evidence of bone loss.
   * Gingival index ≤ 1
   * Plaque index ≤ 1

Exclusion Criteria:

1. Previous orthodontic treatment history.
2. Patients with any systemic disorder that could influence periodontal conditions or response to treatment (such as hypertension, diabetes, or immunological disorders).
3. Patients were on systemic drugs, i.e., antibiotics, hypertensives, analgesics, hormonal drugs, sedatives, and anti-seizure medication, within three months before the baseline examination.
4. Patients who were allergic to ingredients of the probiotics lozenges.
5. Those undergoing periodontal treatment within three months before the baseline examination.
6. Smokers, pregnant or lactating women.
7. Regular use of antibacterial mouthwash.
DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit

To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen's Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of the Phase 3 Amgen Study 20210081 will serve as the basis for establishing the clinical performance of the therascreen® KRAS RGQ PCR Kit as a companion diagnostic (CDx) for the identification of patients with metastatic colorectal cancer, who may benefit from treatment with sotorasib.

The proposed device clinical performance study and the medicinal clinical trial will be conducted simultaneously as a combined trial according to MDCG 2022-10. The clinical trial 20210081 is a Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects with Metastatic Colorectal Cancer with KRAS p.G12C Mutation (CodeBreaK 301). It is estimated that approximately 450 patients from 31 countries will be enroled based on the presence of tumor KRAS G12C mutation, detected using therascreen KRAS RGQ PCR Kit, along with other clinical trial inclusion criteria, into the Phase III clinical trial. Results from the Phase 3 Amgen Study 20210081 will be used to evaluate the clinical performance of therascreen® KRAS RGQ PCR Kit as a CDx device for identification of patients with mCRC who may benefit from treatment with sotorasib in treatment-naïve patients with metastatic colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who consent to participate in the eligibility screen for Protocol 20210081 will have their tumor tissue tested for the presence of KRAS G12C mutation under the proposed performance study.

Exclusion Criteria:

* There is no separate inclusion and exclusion criteria for the performance study.
Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets

European physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol. The study evaluates if selecting the starting dose based on baseline and target LDL-C cholesterol would provide better results (ie proportion of subjects resching target)


Eligibility Criteria:
Inclusion Criteria:

* High cholesterol blood levels (LDL-cholesterol above 100 mg/dL up to 220 mg/dL.
* Triglycerides up to 600 mg/dL.
* History of coronary artery disease (ex.: heart attack, angina), stroke, diabetes or at high risk of such events.

Exclusion Criteria:

* Pregnancy or lactation, use of high statin doses (\>40mg) at baseline, liver or renal problems
* Use of other drugs that would interfere with evaluation of efficacy or cause safety problems
* Uncontrolled hypertension, diabetes or hypothyroidism
* Recent cardiac event of procedure
* High baseline CPK levels