cyrilzakka/clinical-trials huggingface dataset:
A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)

The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.


Eligibility Criteria:
Inclusion Criteria:

Module A Part 1 (Escalation):

* Any participant with histologically or cytologically confirmed advanced/unresectable or metastatic GIST with documented KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation, who has progressed on or was intolerant to at least 1 approved tyrosine kinase inhibitor (TKI) regimen in the advanced/metastatic setting
* Have at least 1 measurable lesion as defined by mRECIST, v1.1
* Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
* Adequate organ function, bone marrow function, and electrolytes
* All participants agree to comply with the contraception requirements
* Have a life expectancy of more than 3 months

Exclusion Criteria:

* Received systemic anticancer therapy or radiotherapy within 14 days prior to first dose of study drug
* Prior or concurrent malignancy that requires treatment or is expected to require treatment for active cancer
* Has known active central nervous system (CNS) metastases or an active primary CNS cancer
* History or presence of clinically relevant cardiovascular abnormalities
* Major surgery within 28 days of the first dose of study drug
* Had systemic arterial thrombotic or embolic events within 6 months prior to the first dose of study drug
* Had venous thrombotic events (e.g., deep vein thrombosis) or venous thrombotic embolic events (e.g., pulmonary embolism) within 1 month prior to the first dose of study drug
* Known allergy or hypersensitivity to any component of the study drug
* Malabsorption syndrome or other illness that could affect oral absorption
* Any other clinically significant comorbidities
The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome

Pioglitazone and rosiglitazone are used in the treatment of diabetic patients. Thiazolidinediones increase insulin sensitivity and show favorable effect blood glucose levels and lipid profiles. The effect of these two different thiazolidinediones on atherosclerotic and inflammatory markers has not been compared in prospective manner. The purpose of this prospective, randomized, open-label, crossover trial is to compare the effect of pioglitazone and rosiglitazone on atherosclerotic and inflammatory markers in patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with at least 3 metabolic syndrome criteria of Asian-Pacific ATP III guideline: fasting blood glucose ≥ 110 mg/dl, systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, triglyceride ≥ 150 mg/dl, HDL-cholesterol \< 40 mg/dl for men and \< 50 mg/dl for women.
* Age: 18 years and above

Exclusion Criteria:

* Hypertensive patients with the use of ACE inhibitor or ARB
* Hyperlipidemic patients with the use of statin or fenofibrate
* Patients with any contraindications to the treatment of thiazolidinediones
* Pregnant or lactating patients
* Chronic alcohol or drug abuse
* Hepatic dysfunction
* Renal dysfunction
* Heart failure (EF \< 50%)
* Expected life expectancy of \< 1 year
Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time

Inclusion-Body Myositis (IBM) results in weakness and the deterioration of distal arm muscles, the symptoms of which are currently assessed through expert examination at clinical visits. Such in-clinic assessments are time-consuming, subjective, of limited sensitivity, and only provide a snapshot of a patient's disease. In this project, the investigators will conduct clinical validation of monitoring digital biomarkers of upper limb function during activities of daily living using a wearable sensor platform that enables frequent, at-home monitoring of upper limb function health in IBM and could be incorporated into IBM trials.


Eligibility Criteria:
Inclusion Criteria:

1. Meet any of the European Neuromuscular Centre Inclusion Body Myositis research diagnostic criteria 2011 categories for IBM.
2. Able to provide informed consent.

Exclusion Criteria:

1. Unwillingness to follow study procedures.
2. Participation in an investigational drug research study within the past 30 days.
Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer

The primary objective of the study is to establish the phase II recommended dose of Vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and bevacizumab for patients with previously untreated advanced non-small cell lunc cancer.

Since the regimen of bevacizumab, carboplatin and paclitaxel has become a standard regimen for the treatment of advanced non-squamous NSCLC, new studies in this patient population will have to include this as a reference arm. Addition of a fourth anti-cancer agent has now become the new strategy to improve the outcome for advanced non-squamous NSCLC. Since the regimen of Vorinostat, Carboplatin and Paclitaxel is already in advanced stage of development it is important to study the safety and tolerability of Vorinostat in combination with the three-drug regimen of Bevacizumab, Carboplatin and Paclitaxel. Therefore, we will evaluate Vorinostat when administered in combination with the regimen of Carboplatin, Paclitaxel and Bevacizumab for patients with previously untreated advanced non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Advanced non-squamous NSCLC
* No prior chemotherapy for advanced disease
* ECOG performance status 0 or 1
* Measurable disease
* Life expectancy \> 3 months
* Normal bone marrow, renal and hepatic function
* Ability to take oral medications
* Willingness to sign informed consent

Exclusion Criteria:

* History of brain metastasis
* Evidence of thromboembolic phenomenon and treatment with anticoagulants
* Pregnancy
* Uncontrolled inter-current illness
* Prior therapy with Paclitaxel
Breast MRI Screening in Women Treated With Mediastinal Irradiation for Hodgkin's Disease

The purpose of this study is to determine if the use of breast MRI in detecting breast malignancies in survivors of Hodgkin's disease is more successful than the traditional mammogram.

* The screening breast MRI and mammography will be performed 6 months or longer after the last mammogram. For pre-menopausal women, the screening will be performed during the second week of the menstrual cycle to reduce cycle-related breast changes. As much as possible, the breast MRI and mammogram are to be performed on the same day.
* On the day of the breast imaging studies, the patient will also be asked to fill out a baseline breast health questionnaire, which includes questions on time since radiation therapy, prior screening history, history of prior benign breast biopsies, menopausal status, prior hormonal therapy use, etc.
* In patients with suspicious findings or findings highly suggestive of malignancy, the abnormal findings will be reviewed with the patient and recommendations will be made for a biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Female patients treated with radiation therapy to the chest area for Hodgkin's disease
* Age between 12 and 35 at initial treatment
* Eight years or longer after initial treatment
* Pre-approval from the participant's insurance company for the breast imaging studies

Exclusion Criteria:

* Pregnant or lactating women
* Post Bilateral mastectomy
* Currently undergoing breast cancer therapy
* Known metastatic cancer
* Patients with contraindications for undergoing an MRI: cardiac pacemaker, known metallic objects in body e.g. metallic clips, bullets, shrapnel or buckshots.
Probiotics and Its Associated Factors on Aflatoxin Biomarkers

The study will be aimed to investigate the effect of probiotic intervention and its associated factors on aflatoxin biomarkers among healthy subjects in Serdang and Kajang, Selangor

The study will be a randomized, double-blind, placebo-controlled, parallel intervention that conducted for 12 weeks and followed-up for 4 weeks among healthy adults under living condition in Serdang and Kajang, Selangor. 164 subjects will be recruited for the intervention study, where 82 subjects will be randomly allocated to the probiotic or placebo group. Probiotic and placebo drinks (80 ml) will be prepared in the form of bottle. Placebo drink will have similar taste, colour, physical appearance, and nutritional value as probiotic drink but contain no LcS. Morning urine samples (15 ml), weight status, and dietary intake will be collected every two weeks from week 0 to week 12 and follow up until week 16 at community centre. Whereas, fasting blood samples (5 ml) and physical activity will be collected every four weeks for 16 weeks at the community centre.

Eligibility Criteria:
Inclusion Criteria:

* Malaysian healthy male or female adults (BMI \<30kg/m2) aged 20 to 60 years who have regular bowel movement (at least 4 times/week), AFB1 \>4.71 pg/mg albumin, and AFM1 \> 0.88 ng/ml

Exclusion Criteria:

1. History or presence of any clinically important disease or disorder (eg. cardiovascular disease, kidney disease, diabetes mellitus, etc.) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
2. Mental status that is incompatible with the proper conduct of the study
3. Functional constipation \[based on Rome III diagnostic criteria with a five-point symptoms based diagnosing tool (0=never or rarely, 1=sometimes, 2=often, 3=most of the time, 4=always)\]
4. Diarrhoea within 2 months prior to the study start
5. Allergic reaction towards probiotic, milk and with gastric problem
6. Lactose intolerance
7. Use of medications or/and antibiotics
8. Use of probiotic, prebiotic and fibre supplements or/and laxatives during the two weeks prior to study start.
9. Drug/alcohol abuse (for alcohol 4 times/day or 20 times/week)
10. Pregnant
11. Reported special diets such as vegetarian, vegan, or macrobiotic
12. Festive (eg. Ramadan, Chinese New Year etc) 3 months before and during the study
13. Participation in another intervention study one month prior to the present study
High Doses of Total End Range Time Offer Better Results Than Low Doses Treating Proximal Interphalangeal Joint Stiffness

Elastic Tension Digital Neoprene Orthosis is a new device that can increase the dose of treatment of the proximal interphalangeal flexion contractures. This treatment improved the results in extension and also reducing the time to obtain it.

Question: In fingers with proximal interphalangeal joint flexion contractures, do significant differences exist between the passive range of motion improvement achieved in joints that receive higher doses of daily total end range time compared to those that receive lower doses of daily total end range time?

Design: Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat

Participants: Fifty-seven fingers in fifty patients suffering a proximal interphalangeal joint flexion contracture

Intervention: The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate extension. Researchers applied two different daily total end range time doses. Group A patients used the orthosis with a dose of twenty to twenty-two hours of daily total end range time while group B patients used the elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours. The exercise program was the same for both groups.

Outcome measures: The researchers performed the goniometric measurements manually twice at the beginning of every session during the three-week period. The first measurement was at the patient arrival after a preconditioning and the second was after twenty minutes. This measurement at the first session was included as a Modified weeks test while at the second, third and forth session was recorded as a contraction test. Patient report of orthosis wear time and

Eligibility Criteria:
Patient Inclusion Criteria:

* Patients with flexion contractures of the proximal interphalangeal joint after trauma or post-surgical complications.
* Patients with long standing flexion contractures
* Patients with contractures greater than 45º.

Exclusion Criteria:

* Patients with acute tendon injuries or fractures
* Patients with inflammatory conditions,
* Patients with proximal interphalangeal joint replacements,
* Patients with Dupuytren conservative treatments
* Patients lacking active proximal interphalangeal joint extension
Talent Converter Post-Approval Study

The primary endpoint is successful secondary endovascular treatment with the Talent Converter stent graft of subjects having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms using the Talent or AneuRx Bifurcated Stent Grafts, in which there is inadequate proximal fixation, seal, overlapping of modular components or unattainable contralateral limb cannulation.

Treatment success is defined as a composite of successful vessel access, successful insertion of the delivery system, successful deployment of the Converter stent graft at the intended treatment site and absence of Type I endoleak at the 1 month follow-up visit.

Converter PAS is an observational study. Patients will receive treatment regardless of study participation. In some cases, patients will be enrolled retrospectively, post implantation.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects in whom a vessel access procedure was/will be performed with the attempted introduction of the Talent Converter Stent Graft for use according to the indications for use in the Instructions for Use (IFU) 0-365 days prior to enrollment.
2. Subjects who are able to understand the nature of the study and give voluntary informed consent.
3. Subjects who are available for follow-up visits.
4. Subjects 18 years of age or older.

Exclusion Criteria:

1. Subjects in whom an attempted treatment was/will be performed with the Talent Converter Stent Graft other than (i.e., primary AUI) as a secondary endovascular intervention for patients having received prior endovascular repair with either a Talent or AneuRx bifurcated stent graft.
2. Subjects in whom an attempted treatment was/will be performed with the Talent Converter Stent Graft as a secondary endovascular intervention for patients having received prior endovascular repair with a bifurcated stent graft other than (i.e., Cook Zenith or Gore Excluder) a Talent or AneuRx bifurcated stent graft.
A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia

This study will hypothesize that the use of a self fixating lightweight mesh in open inguinal repair is feasible in the Philippine setting. It will result in a comparable recurrence rate as published for the traditional Lichtenstein approach.

The specific aim of this study is to assess the feasibility of using a self fixating lightweight mesh in open inguinal hernia under both under regional and local anesthesia in the Philippines. The primary endpoint of which is to assess the recurrence rate at 2 years (with an interim analysis 1 year after the procedure). Secondary endpoints would be to gather data with regards to postoperative pain, post operative surgical complications, wound healing complications, operating factors (mesh deployment time, total operating time), hernia factors (type and size of inguinal hernia).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Informed consent
* Primary inguinal hernia suitable for open inguinal repair
* Reducible hernia

Exclusion Criteria:

* Incarcerated non reducible hernias
* Bleeding disorders
* Patients below 18 (lower age limit) and above 80 (upper age limit) years old
* Hernia defects of greater than 4 cm
Effects of Surgical Timing on Perioperative Clinical Outcomes in Pancreaticoduodenectomy

With the advancement of surgical techniques and the increase in pancreatic oncologic diseases, the volume of pancreaticoduodenal surgeries has been increasing year by year in our center, and multiple pancreaticoduodenal surgeries are often performed on the day of surgery. This study will compare the effect of pancreaticoduodenal surgery performed at different times on patient prognosis. This study plans to divide the patients into morning group, afternoon group, and night group through the start time of surgery, and this study plans to analyze subgroups such as laparoscopic pancreaticoduodenal surgery. The outcome indicators include perioperative complications such as pancreatic fistula, bleeding, abdominal infection, hospitalization cost, and length of hospital stay. The conclusions drawn from this study will suggest to surgeons whether pancreaticoduodenal surgery performed at different times of the day will have different outcomes for patients and will guide surgeons on the timing of pancreaticoduodenal surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be required to sign an informed consent form;
2. Age 18-80 years, male and female;
3. ECOG Physical Status Score (PS Score) 0 or 1.
4. Pancreaticoduodenectomy at our center without contraindications related to the surgery.

Exclusion Criteria:

1. Pre-existing or concurrent other malignant tumors
2. Severe cardiopulmonary and renal dysfunction.
3. Autoimmune disease or history of immunodeficiency
4. Active infections and infectious diseases requiring systemic therapy.
5. History of psychotropic substance abuse, alcoholism or drug addiction.
6. Failure to meet the inclusion criteria as determined by the investigator.
Epidural Loading Prior to Catheter Insertion

This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists.

This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists. Investigators propose to conduct a single blinded, randomized controlled trial to determine if a difference exists in the speed of onset and spread of labor analgesia between patients receiving an epidural loading dose through the epidural needle or catheter.

Group 1 (Epidural Catheter Administration) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural catheter following catheter placement (current standard practice).

Group 2 (Epidural Needle Administration ) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural needle prior to catheter placement (experimental group).

Various parameters will be measured in the time after drug administration to evaluate blood pressure, heart rate, and fetal heart rate. Following delivery, the total anesthetic dose, total number of doses demanded, total number and dosage of rescue doses, and overall patient satisfaction will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. subjects who have volunteered and consented to participation in the study upon admission to labor and delivery
2. parturients in active labor requesting epidural analgesia
3. uncomplicated pregnancy with a reassuring fetal heart tracing
4. age≥18 years

Exclusion Criteria:

1. contraindication to epidural anesthesia
2. inability to read, comprehend, and sign the informed consent form
3. fetal intrauterine growth retardation (IUGR)
4. non-reassuring fetal heart tracing
5. cervical dilation greater than 7cm
6. intra-uterine fetal demise
7. any spinal pathology or neurologic disease
8. history of chronic pain
9. incarcerated patients
10. any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (\>3 attempts, presence of CSF).
Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis

An increased risk of cardiovascular (CV) diseases has been observed in patients with inflammatory bowel diseases (IBD). The impact of IBD drugs, such as anti-TNF, anti-integrins or anti-JAK, on the risk of CV events in IBD is remains unknown. Aortic pulse wave velocity (aPWV), a measure of aortic stiffness, and carotid intima media thickness (CIMT) are both predictors of cardiovascular events and are increased in patients with IBD. The investigators aimed to prospectively compare the CV risk, CIMT, arterial stiffness and biomarkers of endothelial dysfunction at baseline and after 3 and 12 months of anti-TNF, vedolizumab and tofacitinib.


Eligibility Criteria:
Inclusion Criteria:

* Ulcerative colitis evolving for at least 6 months,
* Patient older than 18 years,
* Initiating a treatment by infliximab, adalimumab, golimumab, vedolizumab or tofacitinib,
* Written informed consent.

Exclusion Criteria:

* Patients with anti-hypertensive, antiplatelet or lipid-lowering drugs without stable dosage within the 3 months before the study and over the study period,
* Patients with a cardiovascular event such as myocardial infarction and stroke,
* Diabetic patient,
* Pregnant women,
* Minor
* people unable to give their consent to participate
Topical and Oral Regimen for Skin Health

The overall objective of this study is to assess how oral supplementation with Inner Calm and the use of topical Super Calm can affect the appearance of skin and inner wellness, such as redness, skin sensitivity, and reactionary skin.

The landscape for skin health has expanded past a focused use of topicals to incorporate the use of supplementation. Notable examples include the ingestion of carotenoids and beta-carotene to augment skin antioxidant status or the role of diet on different skin conditions. The role of this investigation is to define how Inner Calm (oral supplementation) may promote healthier skin and how this may work in synergy with Super Calm (topical supplementation).

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-55
* Fitzpatrick skin type 1-4
* Self-perception as sensitive skin

Exclusion Criteria:

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant or breast-feeding women
* Prisoners
* Those who have used isotretinoin in the last 6 months
* Those who have used products containing salicylic acid, beta hydroxyl acids or vitamins A, C, or E or topical retinoids or topical depigmenting agents (such as hydroquinone, kojic acid, azelaic acid, or others in opinion of the investigator) in the last 14 days
* Those who are currently smoking or have smoked within the past 3 years.
* Those who have had a recent surgical or cosmetic procedure in the last 3 months that can affect facial wrinkles, redness, or hyperpigmentation, such as botulinum toxin injections, chemical peels, laser-based therapies to the face, or face lift surgeries
* Subjects with known allergy to any of the components of Inner Calm or Skin Calm
* Those that are unwilling to discontinue use of any other nutritional supplements including antioxidants, herbs, or protein-based supplements for 2 weeks prior to and during their participation.
* Subjects with a diagnosis of acne