cyrilzakka/clinical-trials huggingface dataset:
Phase II Randomized Study of Stereotactic Radiosurgery Plus Fractionated Whole-Brain Radiotherapy Vs Fractionated Whole-Brain Radiotherapy Alone for Multiple Primary or Metastatic Brain Tumors

OBJECTIVES: I. Evaluate whether stereotactic radiosurgery provides local control at multiple sites in patients with primary or metastatic brain tumors, controlled systemic disease, and preserved neurologic function.

II. Examine survival, clinical outcome, and local tumor imaging response in these patients.

PROTOCOL OUTLINE: This is a randomized study. Tumor size and number are confirmed prior to randomization. Patients are stratified by participating institution.

Patients are randomly assigned to 1 of 2 treatment groups. One group is treated with fractionated whole-brain irradiation using megavoltage equipment.

The second group receives stereotactic radiosurgery plus fractionated whole-brain radiotherapy. Stereotactic radiosurgery involves irradiation of all tumors to the margins on stereotactic computerized tomography or magnetic resonance imaging. Either treatment may be administered first; the second treatment begins within 1 month of the first.

Concurrent anticonvulsants and steroids are allowed. Patients are followed for change in size and number of tumors at 1, 3, and 6 months; follow-up clinical exams are performed at least every 2 months.

Eligibility Criteria:
* Multiple newly diagnosed brain tumors
* Histologic confirmation of carcinoma at primary or metastatic site
* Tumors less than 25 mm mean diameter and more than 5 mm from optic chiasm
* No more than 4 tumors on magnetic resonance imaging
* Systemic disease controlled
* Neurologic function preserved
* Radiographic staging within 2 months of randomization required
* Performance status: Karnofsky 70%-100%
Multicenter Registration Study on Allergic Bronchopulmonary Aspergillosis

To understand the current diagnosis and treatment status of ABPA patients, observe their clinical characteristics, prognosis, and treatment outcomes, and identify the relevant factors for poor prognosis in patients.


Eligibility Criteria:
Inclusion Criteria:

Meeting the diagnosis of ABPA according to the ABPA diagnostic criteria specified by the ISHAM-ABPA working group in 2024

Exclusion Criteria:

ABPA patients who are not first diagnosed in the center
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

STACI is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.

STACI is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system. The goal of the study is to demonstrate the effectiveness of the device for its intended use.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 21 at time of screening
2. Patient has lower back / buttock pain for at least 6 months inadequately responsive to non-surgical care
3. Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or sacroiliac disruption)
4. Baseline Oswestry Disability Index (ODI) score of at least 30%
5. Baseline SIJ pain score of at least 5 on 0-10 numerical rating scale
6. BMI \< 35
7. Patient has signed study-specific informed consent form

Exclusion Criteria:

1. ASA score 4 or 5
2. Severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture
3. Other known sacroiliac pathology such as: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture
4. Cluneal neuralgia
5. Previous SIJ implant placement, including allograft
6. Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable device placement
7. History of recent (\<1 year) major trauma to pelvis
8. Previously diagnosed or suspected severe osteoporosis (defined as prior T-score \< -2.5 or history of osteoporotic fracture).
9. Chronic rheumatologic condition (e.g., rheumatoid arthritis)
10. Current diagnosis of fibromyalgia
11. Known allergy to titanium or titanium alloys
12. Current local or systemic infection that raises the risk of surgery
13. Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation
14. Currently pregnant or planning pregnancy in the next 2 years (self-reported)
15. Patient is a prisoner or a ward of the state.
16. Known or suspected active drug or alcohol abuse, including opioids
17. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
18. Currently participating in another interventional clinical trial
A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases

This is a phase III randomized-controlled, single-blind study comparing the standard schedule for antalgic radiotherapy of a single fraction of 8.0 Gy delivered through three-dimensional conformal radiotherapy (3D-CRT) to a single fraction of 20.0 Gy delivered through stereotactic body radiotherapy (SBRT). The primary aim of this trial is to double the complete response rate. Secondary aims are to compare general response rates, duration of pain response, acute and late toxicity, HRQoL through patient-reported outcome measures (PROMs), pain flare, and re-irradiation need.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignancy.
* Pain score ≥ 2 on a scale from 0 to 10.
* Radiological or (bone) scintigraphic evidence of bone metastasis at the site of pain.
* Lesions ≤ 5cm in largest diameter.
* Per lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below.
* No more than 3 painful lesions needing treatment.
* Life expectancy estimated at \> 3 months.
* Patients who have received the information sheet and signed the informed consent form.
* Patients must be willing to comply with scheduled visits, treatment plan, and other study procedures.
* Patients with a public and/or private health insurance coverage.

Exclusion Criteria:

* Myeloma.
* Bone metastasis in previously irradiated sites.
* Previous radioisotope treatment for bone metastases.
* Complicated bone metastasis, i.e. impending and/or existing pathological fracture, spinal cord compression or cauda equina compression \[16\].
* Patients with significantly altered mental status or with psychological, familial, sociological or geographical condition potential hampering compliance with the study.
* Individual deprived of liberty or placed under guardianship.
miRNA Machinery in Melanoma, Melanoma Metastases and Benign Melanocytic Naevi

MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. In the present study, the investigators examines the expression profiles of miRNA machinery components such as miRNA maturation and transport factors, microprocessor complex and RISC subunits in cutaneous melanoma, cutaneous melanoma metastases and benign melanocytic nevi.

Patients with cutaneous melanoma, cutaneous melanoma metastases and benign melanocytic nevi were included in the study. Punch biopsies were harvested from the center of the tumors. The miRNA machinery components were detected by quantitative real-time reverse transcriptase polymerase chain reaction.

Eligibility Criteria:
Inclusion Criteria:

* cutaneous melanoma
* cutaneous melanoma metastases
* benign melanocytic nevi

Exclusion Criteria:

* other forms of malignancy
A Clinical Study Trial of Phenlarmide in China

1. To evaluate the tolerance and safety of FLA tablets in healthy volunteers.
2. To evaluate the pharmacokinetics of FLA tablets in healthy volunteers.
3. Provide basis for dosage setting for follow-up clinical research.


Eligibility Criteria:
Inclusion Criteria:

* 1)18-65 years old (including upper and lower limits);
* 2)Men and women are not limited;
* 3)Men weigh more than 50 kg, women weigh more than 45 kg, BMI 19-28 kg/m2 (including upper and lower limits);
* 4)Understand and sign the informed consent, understand the research process and requirements, and volunteer to participate in this study.

Exclusion Criteria:

* 1)There is a history of heart, liver, kidney, respiratory, digestive tract, nervous system, endocrine, immune or hematological diseases judged by researchers as having clinical significance;
* 2)There are abnormalities in vital signs, general physical examination, laboratory examination and ECG examination, which are judged to be of clinical significance by researchers;
* 3)Any drug was taken within two weeks before the study was administered, and the researchers believe that this condition may affect the evaluation results of the study;
* 4)There is a significant history of drug allergy or hypersensitivity in food that researchers have identified as clinically significant;
* 5)The positive results of serological tests (HBsAg, anti-HCV, anti-HIV or TP-Ab) were found at the time of screening;
* 6)One year before the study was administered, some researchers believed that alcohol or drug abuse history might affect the results of this study, or that alcohol breath test or urine drug screening test were positive during screening;
* 7)Those who had smoking history within three months before the first administration or who had positive urinary cotinine test in screening stage;
* 8)Those who participated in any clinical trial within 3 months before administration;
* 9)Those who donated blood more than 400 mL or 2 units within 3 months before administration;
* 10)Do not agree to avoid the use of tobacco, alcohol or caffeine-containing beverages within 24 hours before and during the trial, or to avoid vigorous exercise, or to avoid other factors affecting drug absorption, distribution, metabolism and excretion;
* 11)Pregnant or lactating women, or those with positive serum HCG test before administration, or those who are unable or unwilling to adopt contraceptive measures approved by the researchers during the study period and within three months after the end of the study, as directed by the researchers;
* 12)Researchers do not consider it suitable for participants in this clinical study.
Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns

The aim of this study is to compare the clinical outcome of using direct esthetic composite restorations and the use of preformed metal crowns in managing MIH cases among a group of Egyptian children.


Eligibility Criteria:
Inclusion Criteria:

* Children with MIH in one fully erupted molar or more.
* Age ranging from 7-12 years.
* Cooperative children
* Good general health.

Exclusion Criteria:

* patients participating in other experiments.
* Patients with parents planning to move away within the following year.
* Patients with only mildly affected MIH molars that do not require extensive restorative treatment.
* MIH-affected molars that have a very poor prognosis and require extraction.
* First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta
The Effectiveness of the LCP in Improving End of Life Care for Dying Cancer Patients in Hospital.

The purpose of this study is to evaluate the effectiveness of the LCP-I Program in improving the quality of end-of-life care provided to cancer patients who die on hospital medical wards as compared to standard healthcare practices.

The availability of an effective quality improvement program for the care of dying patients in hospitals is particularly relevant to the healthcare scenario. The LCP-I Program has provided enough evidence to justify a randomized trial to evaluate its effectiveness.

Although the core objective of the LCP-I is improving the quality of end of life care for dying patients, the Program targets the healthcare professionals working on the hospital ward. The only feasible method of assessing the effectiveness of this Program is by performing a cluster trial, where hospital wards are randomized to receive (or not to receive) the implementation of the LCP-I Program.

Pairs of eligible medical wards from different hospitals will be randomized to receive the experimental intervention (the LCP-I Program) or no intervention at all for the duration of the study.

The LCP-I Program will be implemented in the experimental ward by the PCU. The LCP-I Program has a duration of 6 months from the beginning of the intensive training. No intervention will be implemented in the control ward until the end of the evaluation.

Quality of end-of-life care will be evaluated for each pair of randomized wards for all eligible cancer deaths occurring in the six months after the conclusion of the LCP-I Program in the experimental ward.

Eligibility Criteria:
Ward level

Inclusion Criteria:

* "Medical", "General Medical" or "Internal Medical" ward;
* at least 25 cancer deaths on the ward per year;
* consent from the Hospital and Ward Management to participate to the trial;
* consent from an expert and skills-trained PCU to implement the LCP-I Program

Exclusion Criteria:

- in the hospital another Medical Ward has already been randomised.

Individual level

Inclusion Criteria:

- all cancer patients deceased in the ward during the evaluation period;

Exclusion Criteria:

- the deceased was a relative of a professional working in the hospital.
Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes having failed on basal insulin with or without OAD
* HbA1c greater than 7.0%

Exclusion Criteria:

* Subjects being unlikely to comply with protocol requirements
* Subjects who previously enrolled in this study
* Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
* Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method
Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients

A prospective longitudinal and observational clinical study will be conducted with hospitalized heart failure patients.The main purpose is to know the level of physical activity of these patients after their discharge in relation to the orientation received during their hospitalization and identify the barriers perceived by these patients to participate in a cardiac rehabilitation program. The outcomes are available by telephone calls in 30 and 90 days after discharge.

Heart failure is a progression epidemic problem, parallel to population aging. The costs of this disease are estimates in 38 billion of dollars per year, many of those have a relationship to high number of hospitalizations and decompensated heart failure. Non-adherence to drug treatment and non-pharmacological measures as cardiac rehabilitation are the major causes of high number of mortality and hospitalizations by heart failure. Our objectives will be to identify in decompensated heart failure inpatients the level of physical activity that they done before hospitalization, the barriers for the non-use of cardiac rehabilitation and their disposition to changes of lifestyle. Correlation between level of physical activity and readmission in 30 and 90 days after hospital discharge will be done. To understand the profile of these patients and difficulties for to do physical exercise could help to make future actions with focus in to obtain high adherence to changes in lifestyle.

Eligibility Criteria:
Inclusion criteria Patients in the heart failure protocol of the cardiology program with medical release in the next 72 hours

Exclusion criteria

* Inpatients for more than 30 days
* Younger than 18 years old
* Patients not recommended to do exercises (patients with osteoarticular alterations that doesn't allow the performance of physical exercise)
* Patients with cognitive impairment (Mini Mental \<24), visual or psychiatric impairment which restrain the comprehension of the questionnaires
Dose Response Study of a Natural Extract for Reducing Post Prandial Blood Glucose

Randomized, balanced incomplete block design dose response study of efficacy, with 4 different dosages of mulberry fruit powdered extract added to cooked rice compared to a reference treatment (cooked rice only).

Dose response study with 4 dosages of mulberry fruit powdered extract (0.37, 0.75, 1.12 and 1.5 g) added to cooked rice, compared to cooked rice only(reference) on post prandial blood glucose response in healthy Indian adults.

In addition, 1.5 g of mulberry fruit powdered extract was added to instant rice porridge and compared to instant rice porridge only as positive control (replication of previous research.

In total there were 7 test products in the study: 5 active treatments and 2 reference treatments.

The study was a cross-over study (4 interventions per subject, 4 out of the 7 test products). The recovery period between treatments was at least seven days.

Eligibility Criteria:
Inclusion Criteria:

* Willing to give consent to participate in the study in writing;
* Healthy male and female subjects between ≥ 20 and ≤ 50.0 years of age;
* BMI of ≥18.0 and ≤ 25.0 kg/m2;
* Apparently healthy: no medical conditions which might effect study measurements as judged by the study physician or measured by questionnaire, and/or assessed by hematology, blood chemistry and urinalysis;
* Willing to comply to study protocol during the study;
* Agreeing to be informed about medically relevant personal test-results by study physician;
* Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
* Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
* Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for females 11 to 15 gm / dL; both inclusive) as judged by the research physician.

Exclusion Criteria:

* Being an employee of Unilever of Lambda;
* Chronic smokers, tobacco chewers and drinkers;
* Participation in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the screening period;
* High intake of alcohol (\>120 mL/week);
* Reported use of medically prescribed/slimming diet;
* Reported participation in night shifts (between 23.00 and 6.00 hrs);
* Use of medication which interferes with study measurements including vitamins, tonics;
* Reported intense exercise ≥10 h/week;
* Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening
* Blood donation for 2 months prior to screening;
* Urine analysis that showed any drug abuse;
* Allergy to any food or cosmetics;
* If female, not being pregnant or planning pregnancy during the study period;
* If female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.
Effects of Panax Ginseng and Salvia Miltiorrhiza Supplementation on Vascular Function

The purpose of is to determine the preventive effects of Chinese herb supplement with panax ginseng and salvia miltiorrhiza prior to eccentric resistance exercise on arterial stiffness and vascular reactivity by using a double-blind randomized control design and to examine the effects of a 12-week progressive eccentric resistance exercise training on arterial elasticity and vascular reactivity, and whether a long-term supplementation would ameliorate arterial stiffening effects elicited by exercise-induced inflammation and improve endothelial function.


Eligibility Criteria:
Inclusion Criteria:

-Healthy sedentary adults

Exclusion Criteria:

* obesity (BMI \>30 kg/m2)
* smoking within past six months
* hypertension (high blood pressure \>140/90 mmHg)
* personal history of diabetes (fasting blood glucose \>126 mg/dL), heart disease, or other cardiovascular problems
* orthopedic injury that may prevent him or her from completing the exercise
* the use of over-the-counter supplements or vitamins
Evaluate the Clinical Efficacy of Whole Body Cryotherapy in the Cryosense Cabin for the Treatment of Fibromyalgia

The aim of this study is to evaluate the effectiveness of an intervention with sessions of 3 minutes of whole body cryotherapy (WBC) in the Cryosense cabin. Measurement period time: 8 weeks.

The aim of this study is to evaluate the effectiveness of an intervention with sessions of 3 minutes of whole body cryotherapy (WBC) in the Cryosense cabin, on the main clinical manifestations of patients with Fibromyalgia (FM).

A randomized, open and crossed 8-week clinical trial comparing a WBC intervention with the waiting list control group. Patients diagnosed with FM according to ACR 2010 criteria, in treatment and regular follow-up recruited consecutively. Two groups were made, one of intervention and one of waiting list which served as control during the first phase. At the end of the first phase, and after a week of washout, the groups crossed and went on to carry out the second phase following the opposite intervention. The pharmacological treatment was not modified during the entire study.

Trial endpoints were changed in pain after 2 and 4 weeks, measured by a visual analogue scale (VAS) and burden of disease, evaluated by the Fibromyalgia Impact Questionnaire(FIQ).

Eligibility Criteria:
Inclusion Criteria:

* Age between 25 and 80 years old
* Diagnosis of Fibromyalgia according to ACR criteria
* More than 1 year from diagnosis
* Lack of response or partial response to previous treatment
* In case of women,commitment not to get pregnant during the study.

Exclusion Criteria:

* Patiens with cardiovascular or psychiatric comorbidity
* Cold intolerance
* Changes in pharmacological treatment during the study
* Body temperature over 37,5ºC
Comparative Effect of Graston Technique and Petrissage Technique on Tight Trapezius Muscles in Young Adults

This research aims to contribute valuable insights into the potential benefits of incorporating the portable wedge device into preventive or therapeutic interventions for calf-related musculoskeletal issues. By combining economical, ergonomic principles and user-friendly features, the proposed device offers individuals a convenient and efficient means to enhance their calf flexibility, ultimately mitigating strain and reducing spasms.

Developing and successfully integrating a portable wedge device could mark a significant breakthrough in preventive and rehabilitative care for musculoskeletal problems associated with the calf region. This innovative device can enhance the overall well-being and musculoskeletal health of individuals suffering from such issues, providing a more effective and convenient treatment solution.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients diagnosed with Trapezius tightness
* Age above 18-30
* Presence of active trigger points in the upper trapezius muscle
* Participants who are volunteer for the study
* Patients who suffer from shoulder pain and stiffness due to bad posture

Exclusion Criteria:

* History of whiplash injury
* History of head, neck, cervical spine or shoulder surgery
* History of cervical radiculopathy
* Diagnosed fibromyalgia and myopathy
* History of cancer
* Pregnancy Myofascial therapy within the past month
* Contraindication of dry needling and instrument-assisted soft tissue mobilization technique