cyrilzakka/clinical-trials huggingface dataset:
Instrument Based Fascial Abrasion Versus Myofascial Release Technique in Cervicogenic Headache Patients

Study will be randomized clinical trial. Data will be collected from non probability consecutive sampling technique. Total 44 participants from Rafiqa Hospital and District Headquarter (DHQ) Sargodha will be selected and randomly allocated to two different groups i.e Group A and Group B. Group A will be treated with Instrument assisted Fascial Abrasion and Conventional Therapy for 5 minutes, 6 sessions (3 sessions per week) (12) while Group B will be treated with Myofascial Release Technique and Conventional Therapy for 2 to 3 minutes, 5-7 repetitions and 3 sessions per week on alternate days were given for 6 weeks. NPRS, MOS-36, NDI will be used as outcome measuring tool before and after treatment. Data will be analyzed by using Statistical package for social sciences 25.

Cervicogenic headache is a symptomatic headache characterized by chronic, hemi cranial pain syndrome in which pain sensations originates in cervical spine and soft tissues of the neck and basically referred to head. Cervicogenic headache originates in the upper cervical region, and the headache mechanism involves nociceptive structures such as the upper cervical spinal nerves, ganglia, disks, facet joints, muscles, and ligaments. Consequently, the anatomical structures innervated by cervical roots C1-C3 are potential sources of Cervicogenic headache.

Myofascial Release (MFR) is a therapeutic technique that uses gentle pressure and stretching (in both forms of direct and indirect approaches) with the intention of restoring decrease pain, optimizing length and facilitating the release of fascial restrictions caused by injury, stress, repetitive use, etc. There are some studies about MFR and its effects which include: increase extensibilities of soft tissues, increase ROM, improves joint biomechanics, increases temperature of fascia, increases blood circulation to the muscles and decreases pain and muscles tone significantly.

Although; a lot of remedies such as physiotherapy, electrotherapy, exercises therapy and spinal mobilization are used for cervicogenic headache, but sub-occipital MFR for Cervicogenic headache has not been studied specifically. Another technique used for cervicogenic headache includes Fascial Abrasion Technique tool that is a revolutionary tool that can quickly and effectively loosen muscle tissue/fascia. It improves range and quality of movement.

Eligibility Criteria:
Inclusion Criteria:

* Patients having headaches with neck stiffness and pain.
* Headache for the past 3 months at least once per week.
* Positive flexion rotation test and restriction greater than 10°
* Patient aged 18-66 years old.

Exclusion Criteria:

* Headache not of cervical origin.
* Physiotherapy or chiropractic treatment in the past 3 months.
* Headache with autonomic involvement, dizziness and visual disturbance.
* Congenital conditions of Cervical spine
Detection of Circulating Tumor Cells in Patients With Sarcomas

The sarcomas represent 1% of all cancers in adults, 8% in adolescents and young people, and 10% in children. Even though it is a rare cancer, it contributes to a significant loss of years of life in comparison with other types of cancer, due the fact that it affects children and young people. The diagnosis and treatment are difficult, considering the diversity and rarity of this disease. In addition, on average, more than 50% of patients with high-grade sarcoma present tumor relapse and distant recurrence is considered the main cause of death. The presence of Circulating Tumor Cells (CTCs) in the blood of patients with sarcoma may be an early marker of tumor invasion, because it is known that the CTCs circulate in the blood for months or years before the development of metastases. The CTCs can be used to monitor the response of the tumor to treatment, in order to match time, dose, and type of therapy.

Objectives: collect blood from patients with different types of sarcoma (leiomyosarcoma, synovial sarcoma, pleomorphic sarcoma and liposarcoma) in order to isolate and quantify CTCs. The investigators also have an intention to identify genes of resistance to treatment in these cells.

Methodology: This is a prospective study, to be made by whole blood collection from 40 patients with different types of sarcomas (leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and liposarcoma). The collections will be made in three different moments: before the beginning of the treatment, during and at the end of this (8 mL). Blood samples will be processed and filtered on ISET system for the isolation and quantification of CTCs. Later, it will be performed immunocytochemistry (ICQ) single and/or double staining for protein assessment. The following proteins will be assessed: CD45, MRP1, MRP2 and MRP7.

Expected Results: The investigators hope that this study can show if the CTCs can be used as "liquid biopsy" in patients with leiomyosarcoma, synovium and pleomorphic sarcoma and liposarcoma.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or more;
* types of sarcomas: leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and liposarcoma.
* extension of the disease determined by physical examination and imaging;
* measurable disease by RECIST criteria (Response Evaluation Criteria in Solid Tumors);

Exclusion Criteria:

* patients who have undergone previous therapy in the last three weeks;
* patients with a history of other cancer in the past two years.
A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy

This is a single center, open-labeled, single arm phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients unsuitable for intravenous chemotherapy.

Fruquintinib is an oral small molecule inhibitor of VEGFR1/2/3, this phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients of elderly or those unsuitable for intravenous chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old at the time of signing the informed consent;
2. Histologically or cytologically confirmed unresectable metastatic colorectal cancer;
3. Haven't received systematic therapy after diagnosis of metastatic colorectal cancer;
4. Intolerable to standard treatment of oxaliplatin- or irinotecan-based intravenous combination therapy;
5. At least one measurable lesion(s);
6. ECOG PS 0-2;
7. Life expectancy≥3 months;
8. Adequate organ and bone marrow functions;
9. Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration;
10. Willingness and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

1. Previous treatment with VEGFR inhibition;
2. Participating in other drug clinical trials within 4 weeks before recruited;
3. Have received other systemic anti-tumor therapies within 4 weeks before recruited;
4. Non-controlled hypertension after monotherapy, that is, systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg;
5. Proteinuria ≥ 2+ (1.0g/24hr);
6. Clinically significant electrolyte abnormality;
7. Clinically significant cardiovascular diseases;
8. Thromboembolism or arteriovenous events occurred 6 months before recruited;
9. ≥grade 3 bleeding events 4 weeks before recruited;
10. Evidence of CNS metastasis;
11. Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI;
12. Active, symptomatic interstitial lung disease causing dyspnea (≥ grade 2 dyspnea), pleural effusion or ascites;
13. History of organ transplantation;
14. APTT \>1.5×ULN or INR\>1.5;
15. History of HIV infection or active hepatitis B / C;
16. Allergic to fruquintinib and / or capecitabine;
17. Pregnant or lactating women;
18. Clinically detectable secondary primary malignancies at the time of enrollment (excluding fully treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
19. Patients who are not suitable for the study judged by the researchers.
Morphine for Dyspnea in Pulmonary Fibrosis

"Determination of the effectiveness of nebulized morphine in the treatment of dyspnea in patients with advanced idiopathic pulmonary fibrosis"


Eligibility Criteria:
Inclusion Criteria:

* IPF diagnosis in accordance with guidelines

  * Period of stable disease
  * Dyspnea rated 3 to 4 in mMRC scale
  * Current non-smoker
  * Other potential causes of breathlessness such as kidney or heart failure optimally treated in the opinion of the principal investigator
  * Able to complete questionnaires and trial assessments
  * Ability to give informed consent
  * If female, must be:

    1. postmenopausal (no menses for 12 months without an alternative medical cause)
    2. sterile
    3. using acceptable contraception and agree to exclude pregnancy with pregnancy test in the beginning of the hospitalization

Exclusion Criteria:

* - other coexisting severe chronic lung diseases
* absolute contraindications to six-minute-walking-test according to

Polish Respiratory Society guidelines:

* \< 7-10 days since coronary interventions due to STEMI
* \< 24 h since planned coronary intervention
* myocarditis/pericarditis
* symptomatic rhythm and conduction abnormalities
* acute deep vein thrombosis, pulmonary embolism, pulmonary infarction
* decompensated heart failure
* acute infection and other diseases which can significantly impact the test result (eg. severe anemia, acute kidney or liver failure, hypo- or hyperthyroidism, etc)

  - contraindications to morphine hydrochloride:
* previous history of respiratory depression after opioid administration
* previous history of allergic reactions to opioids
* severe ventilation impairment due to e.g. asthmatic state, airway foreign body
* severe kidney or liver failure
* increased intracranial pressure
* head injury
* cerebral edema
* coma
* seizure disorders
* acute alcohol poisoning
* acute abdomen
* acute diarrhea caused by infection or food poisoning;
* patients at risk of paralytic ileus;
* biliary colic;
* phaeochromocytoma;
* simultaneous MAO inhibitor treatment and immediate 2-week period following its discontinuation - ongoing opioid treatment for any indication
Physical Therapy Management in Degenerative Lumbar Diseases and Osteoporosis

Low back pain is a common health issue in elderly population. According to the statistics, more than 80% of Taiwanese suffer low back pain in the life. The cause of low back pain includes lumbar spondylosis, osteoporosis, compression fracture, muscle strain, spondylolisthesis...etc. In addition to drugs and surgery, physical therapy is an alternative choice for conservative treatment. Therefore, in this study, the investigators propose to analyze the physical examination, diagnostic methods, X ray, physical therapy records, physical therapy methods and clinical outcomes in patients with the diagnosis including lumbar spondylosis, low back pain, osteoporosis, compression fracture, back pain treated at National Taiwan University Hospital and received rehabilitation at the Physical Therapy Center in recent ten years.


Eligibility Criteria:
Experimental group:

Inclusion Criteria:

* patients with the diagnosis including lumbar spondylosis, low back pain, osteoporosis, compression fracture, back pain treated at National Taiwan University Hospital
* received rehabilitation at the Physical Therapy Center in recent ten years.

Control group:

Inclusion Criteria:

* patients with the diagnosis including lumbar spondylosis, low back pain, osteoporosis, compression fracture, back pain treated at National Taiwan University Hospital
* not received rehabilitation at the Physical Therapy Center in recent ten years.
Agile Development of a Digital Exposure Treatment for Youth With Chronic Musculoskeletal Pain

This project proposes to systematically develop and evaluate the feasibility and preliminary effectiveness of a digitally delivered, graded exposure treatment for youth with chronic musculoskeletal pain, utilizing a sequential replicated and randomized single-case experimental design (SCED). SCED provides the opportunity to rigorously evaluate treatment effectiveness at the individual level.

Development of iGET Living will be based on a series of short iterations, with alpha testing (Aim 1) on a small sample of adolescents with chronic pain (N = 15). For Aim 1, participants will participate in three, two hour focus groups (one per week over the course of three weeks), resulting in 6 total hours of participation per participant for Aim 1.

Aim 2 will involve a sample (N = 20 youth) of naïve end-users. Participants will be enrolled in a baseline period ranging from 7-25 days (done to support SCED methodology) after which they will be enrolled in the online intervention program, lasting 6-weeks. Patients will be contacted 3-months post-discharge from treatment (week 22 of enrollment) and will complete self-report outcome measures at this time.


Eligibility Criteria:
Inclusion Criteria:

* Youth ages 10-18
* Have diagnosis of chronic musculoskeletal pain (\>3months)
* Have moderate to high pain interference (PROMIS Pain Interference ≥ 61)
* English literate
* Have access to computer, smartphone, or tablet with internet connection

Exclusion Criteria:

* Significant cognitive impairment (e.g., brain injury)
* Significant medical or psychiatric problems that would interfere with treatment
Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants

RATIONALE: The Genetic Epidemiology and Risk Assessment program may be more effective than usual care in increasing the number of healthy participants who regularly receive screening for colorectal cancer.

PURPOSE: This randomized clinical trial is studying the Genetic Epidemiology and Risk Assessment program to see how well it works compared with usual care to increase colorectal cancer screening in healthy participants.

OBJECTIVES:

* Compare Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization by healthy participants.
* Determine the impact of GERA feedback and UC on psychological distress in these participants.
* Compare GERA feedback vs UC in terms of intention to have CRC screening, perceived CRC risk, CRC knowledge, salience and coherence of CRC screening, and support for CRC screening in these participants.
* Identify factors that moderate the impact of GERA feedback on CRC screening utilization.

OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 screening arms.

* Arm I: Participants receive standard primary care.
* Arm II: Participants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment (GERA) intervention. Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk.

All participants undergo a fecal occult blood test 3 weeks after the screening office visit.

PROJECTED ACCRUAL: A total of 1,950 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Healthy participants meeting the following criteria:

  * No personal history of colorectal polyps or cancer or inflammatory bowel disease
  * No family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer (CRC), or CRC in more than 1 first-degree relative
* Nonadherent with standard CRC screening recommendations at the time of their index office visit

PATIENT CHARACTERISTICS:

* Able to communicate with ease in English

PRIOR CONCURRENT THERAPY:

* More than 6 weeks since prior antibiotics or antifolate medications (e.g., sulfasalazine, methotrexate)
Relationship of Glycemic Index Values and Subjects' Body Composition Parameters

Glycemic index concept is widely used to determine impact of a food to blood glucose. Although the previous studies showed that glycemic index did not seem to be related with subject-specific factors, currently several studies found conflicting results on the relationship of subjects' characteristics and glycemic index values. This study aims to determine whether body composition parameters, as subject-specific factor, correlate with glycemic index values.

Glycemic index methods are performed according to Food and Agricultural Organization/WHO recommendations.

Eligibility Criteria:
Inclusion Criteria:

* age between 20-40 years
* fasting blood glucose 70-100 mg/dL
* Indonesians

Exclusion Criteria:

* having diabetes
* smoking
* if women, pregnant or lactating
* being allergic to food used in this study
* having gastrointestinal disturbance
* in regular medication
* refusal to sign the consent form
TransplantLines: the Transplantation Biobank

TransplantLines is an observational cohort study in all solid transplant recipients, i.e. kidney, heart, lung, liver, small bowel and pancreas. In this study we will gather questionnaires about topics affecting transplant recipients, e.g. QoL, work and physical capacity. Moreover, we will collect multiple urine and blood samples for analysis. Additionally, we will store hair, nails and faeces from the transplant recipients. Next to this, we will perform physical capacity tests and cognitive tests.

The last decades, the acute period after transplantation has markedly improved due to improved tissue-matching techniques and better immunosuppressive drugs. However, nowadays the major aim after transplantation is the long-term patient and graft survival which are still poor, where half of the RTR looses their graft after 10 years. With TransplantLines we are setting up an extensive biobank to improve the long-term survival after transplantation. Moreover, we are one of the few studies to collect across transplant specialities. Like mentioned in the brief summary, extensive questionnaires will be send to participants prior to the visit containing multiple questionnaires (e.g. SF-36, WHODAS, PQ-SGA etc.). During the visit, we will collect multiple blood samples who will be taken during the regularly visit to the clinician. Moreover, two tubes from 24-hour urine collection will be collected, faeces, hair and nails will be stored. Finally, physical tests and cognitive tests will be performed with the participants (e.g. 2-min walking test, 4m walking test, timed-up-and-go test etc.).

Eligibility Criteria:
Inclusion Criteria:

* Solid organ transplant recipients

Exclusion Criteria:

* Age younger than 18 years old
* Cognitive dysfunction
A Pharmacodynamic Effect Study of AP301 in Healthy Volunteers

This is a randomized, open-label, parallel-group, phase 1 study to evaluate the PD effect of AP301 capsule in healthy volunteers. The study is planned to have 4 treatment arms: Arm 1: 2.10 g/day; arm 2: 4.20 g/day; arm 3: 6.30 g/day; arm 4: 8.40 g/day.

A total of 32 participants will participate in this study and the study consists of 3 periods such as screening period, hospitalization period and follow up period.

Eligibility Criteria:
Important Inclusion Criteria:

* Healthy male volunteers, 18-55 years of age
* Body mass index (BMI) 18-30 kg/m2 (exclusive) at screening.

Important Exclusion Criteria:

* Serum phosphorus is below 1.00 mmol/L at screening.
* History of significant gastrointestinal disease or disorder, major gastrointestinal surgeries, or cholecystectomy
* History or symptoms of any clinically significant kidney, liver, broncho-pulmonary, gastrointestinal, neurological, psychiatric, cardiovascular, endocrine/metabolic, hematological diseases, or cancer.
* History of specific allergies or allergic conditions or known allergies to the study drug as judged by the investigator, or any confirmed significant allergic reactions (urticaria or anaphylaxis) to any drug, or multiple drug allergies (non-active hay fever is acceptable). Allowing for childhood asthma, history of mild eczema that has had no flare ups for ≥5 years or is fully resolved.
* Known history of allergy to common food like milk or gluten, or lactose intolerance, or special diet habit for religious/life-style reasons, which might potentially jeopardize the participant's compliance of study diet.
* Any clinically significant concomitant disease, or condition or treatment that could interfere with the conduct of the study.
* Confirmed (based on the average of 3 separate resting blood pressure measurements, after at least 5 minutes rest) systolic blood pressure (BP) greater than 150 or less than 90 mmHg, and diastolic BP greater than 90 or less than 50 mmHg at screening.
* Clinically relevant ECG abnormalities on screening ECG.
* Estimated glomerular filtration rate (eGFR) ≤ 70 mL/min/1.73 m2.
* Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCV Ab) or human immunodeficiency virus (HIV-1 or HIV-2 Ab).
* Alanine aminotransferase (ALT) or aspartate transaminase (AST) \> 1.5 × upper limit of normal (ULN), or any other clinically significant abnormalities in laboratory test results at screening.
* Dosed with a small-molecule or biologic investigational drug within 30 days or 90 days, respectively, or 5 half-lives (whichever is the longer) prior to first dose of this study.
* Positive urine test for drugs of abuse and/or positive alcohol test at screening.
* Any medical or social conditions that, in the view of investigator, might potentially jeopardize the participant's compliance of study.
A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction

Our study is the prospective randomized study for efficacy of uncovered double bare metallic stent compared to uncovered single bare metallic stent in malignant biliary obstruction


Eligibility Criteria:
Inclusion Criteria:

* The patients who had malignant biliary obstruction

Exclusion Criteria:

* The patients who had resectable biliary malignancy
* The patients who had hilar obstruction
* The patients who had duodenal obstruction
* The patients who had other malignancy which is not related to biliary obstruction
* The patients who had uncontrolled infection
* The patients who had poor performance (ECOG =3 or 4)
* The patients who were not acquired informed consent
* The patients who had technically difficult structure for ERCP