cyrilzakka/clinical-trials huggingface dataset:
A Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Maintenance Treatment With Capecitabine Plus Cetuximab in Metastatic Colorectal Cancer

This is a single arm, open-label, multi-center clinical trial to evaluate the efficacy and safety of maintenance treatment with capecitabine plus cetuximab after first-line 5-fluorouracil-based chemotherapy plus cetuximab for patients with RAS wild-type metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects has been fully understand this research and volunteered to sign the consent form;
2. Histologically and/or cytologically diagnosed with RAS wild-type metastatic metastatic colorectal cancer(Phase IIIc/IV), any other histological type is excluded;
3. Subjects with stable disease or better after induction treatment with eight to twelve 2-weekly cycles of 5FU-based standard chemotherapy;
4. ECOG Performance Status (ECOG PS) ≤1(0-1);
5. Evident measurable lesion(s) that meets the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
6. Expected survival\>16 weeks.

Exclusion Criteria:

1. Subjects with presence of clinically detectable second primary malignant tumors at the enrollment, or other malignant tumors within the last 5 years (excluding adequately treated skin basal cell carcinoma or carcinoma in situ of cervix);
2. Clinical refractory diseases(including uncontrolled epilepsy),and affect survivor;
3. Central Nervous System (CNS) metastatic disease or prior cerebral metastasis;
4. Researchers think that the subjects exist any clinical or laboratory abnormalities or compliance issues and not suitable to participate in this clinical study.
Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics

Inspiratory muscle training (IMT) can reverse or delay the complications from the deterioration of inspiratory muscle function in asthma. Thus, the IMT has been considered a treatment option for people with asthma. The aim of this study is to investigate the training principles of intensity, specificity and reversibility of IMT in asthmatics.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma
* Adults (18 - 60 years)

Exclusion Criteria:

* Inability to perform the protocol established by the study
* Others respiratory diseases
* Request for study withdrawal
The Effects of Almond on Facial Skin Collagen and Wrinkles

Investigate the effects of almond consumption on collagen production, elastin levels, wrinkles, and pigmentation among premenopausal women and postmenopausal women belonging to all Fitzpatrick skin types.

Almonds are energy-dense and rich in beneficial nutrients including B vitamins, vitamin E, mono- and polyunsaturated fatty acids, protein, fiber, minerals and polyphenols. Polyphenols and vitamin E in almonds provide protection to the body in part, through their ability to combat oxidative stress. Clinical studies have demonstrated beneficial effects of almond consumption on diseases such as diabetes and cardiovascular disease.

Almond consumption has been shown to significantly decrease wrinkle severity in two clinical studies conducted with postmenopausal women with Fitzpatrick skin type I and II. Almond intake has also been shown to increase resistance to erythema induced by ultraviolet exposure. The extracellular matrix contains proteins including collagen and elastin, which contributes to the integrity of the skin. Enzymatic and ultraviolet radiation induced degradation and a reduction in synthesis of collagen and elastin contribute to wrinkle formation. Furthermore, the process of menopause decreases the level of estrogen which affects the skin in several ways, including a decrease in skin collagen and hydration, and an increase in wrinkling.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 35 to 70 years of age of all skin types
* 50% of the subjects will be postmenopausal women determined as \>1-year loss of menstrual period
* 50% of the subjects will be premenopausal women
* BMI 18.5 - 35 kg/m2
* Individuals with a habitual diet that has been maintained for at least 6 months and to be maintained for the duration of the study
* Individuals must maintain their usual skincare products, defined as products that has been used for at least 1 month, for the duration of the study

Exclusion Criteria:

* Those with a nut allergy
* Those who are unwilling to discontinue oral collagen supplementation 1 month prior to the start of the study
* Individuals who are unwilling to discontinue vitamin E or nut containing supplements 2 weeks prior to and during the intervention.
* Individuals who are pregnant or breastfeeding
* Change in skincare products during the study
* Had a medical or cosmetic procedure such as laser resurfacing or plastic surgery to the face within the last 6 months (include botulinum toxin, dermal fillers, collagen, or other similar cosmetic procedure)
* Has an autoimmune photosensitive condition or known genetic condition with a deficiency in collagen production (such as Ehler-Danlos)
* Those with a skin disease on their face that would affect the assessment of their skin based on the assessment of the investigator.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years
Kinesio Taping Effectiveness on Idiopathic Toe Walking

Idiopathic Toe Walking (ITW) is a diagnosis normally of exclusion and likely, consequently, is approached in vastly varying ways of intervention, including serial casting, Botox injections and physical therapy. There is some evidence in the literature that children with ITW can somewhat correct their lack of heel-strike gait pattern at least temporarily. Kinesio Taping (KT) method is an intervention that is used in the outpatient physical therapy setting for various conditions such as post-operative edema, muscle facilitation of weakened rotator cuff muscles, and functional corrections in children with torticollis. This pilot study will strive to determine if KT may be effective by providing proprioceptive and neuromuscular re-education through thermal and mechanical fascial impositions, thereby improving passive joint range of motion (ROM) through reduction of passive muscle stiffness and improving ambulation through neuromuscular re-education in children with idiopathic toe walking. We will quantify passive muscle stiffness of the gastrocnemius and opposing anterior tibialis using non-invasive Shear Wave Elastography (SWE). Further we look at the kinematics and kinetics of the child's ankle during the gait cycle to further determine any effect(s) of KT on functional walking outcome measures. The intent is that the results from this study will serve as a platform from which to expound look at the long-term, if any, effects of KT on the muscle property and gait cycle pattern in children with ITW.


Eligibility Criteria:
Inclusion Criteria:

* Females and males
* 3-10 years of age
* who independently ambulate
* have a diagnosis of idiopathic toe walking

Exclusion Criteria:

* Children will be excluded if they have a diagnosis of or suspected neuromuscular disorder
* had prior treatment for ITW including bracing or including splinting in the last six months, chemodenervation, serial casting in the last six months, surgical intervention
* diagnosis of Autism or Pervasive Developmental Disorder
* history of allergic reactions to tape/adhesives.
Effects of Different Early Intensive Therapies on Long-term β-cell Function

The purpose of this study is to investigate and evaluate the effects of different oral antihyperglycaemic agents combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.metformin and pioglitazone combined with CSII; 3. sitagliptin combined with CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed type 2 diabetes
* fasting blood glucose (FBG) level ranging from 7.0～16.7 mmol/L
* body mass index (BMI) ranging from21～35kg/m2
* Antihyperglycaemic and antihyperlipidemic medication-naive patients

Exclusion Criteria:

* having any severe acute or chronic diabetic complications
* renal dysfunction, blood creatinine≥150µmol/L
* blood aminotransferase level rising up(more than 2 times of the upper normal limit of ALT)
* • Any severe cardiac disease including congestive cardiac failure, unstable angina or myocardial infarct in 12 months
* chronic or acute pancreatic disease
* severe systematic diseases or malignant tumor
* female patients incline to be pregnant
* being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
* poor compliance
Vitamin D Supplementation for Bipolar Depression

The purpose of this study is to whether vitamin d supplementation in those with low levels may reduce depression symptoms in people experiencing bipolar depression.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>18years old
* Bipolar disorder (I,II or NOS),
* MADRS Score\>7 (mild),
* 25(OH)D level \<30ng/ml (insufficient).
* able to take the prescribed vitamin D by mouth

Exclusion Criteria:

Systemic diseases such as:

* liver and kidney diseases,
* known parathyroid disorder,
* disorders of vitamin D metabolism,
* taking vitamin D replacement therapy,
* fat digestion disorder,
* diabetes mellitus,
* gi surgery
* If the serum calcium in the range 2.50-2.55 mmol L, inclusion required a serum PTH below 5.0 pmol L-acute psychiatric urgency:
* active suicidality,
* acute psychosis,
* active substance use\<6mo or
* pregnant or nursing females
Pressure Wire Guidance for Infrapopliteal Artery Interventions

"• A prospective, single-center randomized controlled comparison trial.

* A total of 100 patients with symptoms of chronic limb-threatening ischemia (Rutherford category 5) undergoing endovascular treatment for anterior tibial artery or posterior tibial artery lesions will be included if they meet the inclusion criteria and do not meet any exclusion criteria.
* Patients will be randomized in a 1:1 open-label manner either to the pressure wire-guided group or the angiography-guided group.
* Patients will be treated with balloon angioplasty for anetrior tibial artery or posterior tibial artery lesions.
* In the angiography-guided group, balloon angioplasty will be performed to achieve an optimal procedural result, as determined by angiography. Optimal results are defined as antegrade blood flow without residual stenosis \>50% or flow-limiting dissection.
* In the Pressure Wire-guided gorup, balloon angioplasty will be performed to obtain optimal procedural result based on both angiography and a pressure gradient over the target lesion. Optimal pressure gradient is less than 10 mmHg by measurement using a Pressure Wire.
* The primary efficacy endpoint is defined by attaiment of skin perfusion pressure ≥50 mmHg within 1-3 days after the index procedure.
* Patients will be followed at 1, 3, and 6 months after the procdure to assess wound healing status, and clinical events."

1. Prospective, singlecenter, open label, randomized controlled study
2. Eligible patients with chronic limb-threatening ischemia (Rutherford category 5) undergoing endovascular treatment for anterior tibial artery or posterior tibial artery lesions will be randomized to pressure wire-guided or angiography-guided groups.
3. All patients will undergo balloon angioplasty for anterior or posterior tibial artery lesions, with the angiography-guided group aiming for optimal procedural results based on angiography, and the pressure wire-guided group aiming for optimal results based on both angiography and pressure gradient measurements.
4. The primary efficacy endpoint is attainment of skin perfusion pressure ≥50 mmHg within 1-3 days after the procedure.
5. Clinical follow-up will occur at 1, 3, and 6 months to assess wound healing and clinical events.

Eligibility Criteria:
Inclusion Criteria:

* Patient with chronic limb threatening ischemia (Rutherford 5)
* Anterior tibial artery or posterior tibial artery lesions ≥ 10 cm Age ≥19 years

Exclusion Criteria:

* Acute limb ischemia
* Contraindication to antiplatelet or anticoagulation agents:

  1. Thrombocytopenia (platelet \<100,000/uL)
  2. Previous cerebral hemorrhage, GI bleeding, other reasons for increased bleeding risk within 6 months
* Pregnant women or women with potential childbearing
* Life expectancy \< 1 year
Randomized, Placebo-controlled Study to Evaluate Effects of E5555 on Renal Function Parameters and OCT2 Activity

This is a drug-drug interaction study to evaluate the effects of steady-state exposure of E5555 and its main metabolites on the pharmacokinetics (PK) of metformin, an organic cation transporter-2 (OCT2) substrate. In addition, the study will also investigate the effects of E5555 on several renal function parameters.


Eligibility Criteria:
Inclusion Criteria:

- Healthy male or female subjects aged greater than or equal to 18 years to 55 years

Exclusion Criteria:

* History of any medical condition which will result in an increased risk of bleeding including but not limited to active or recurrent gastric ulcers, recent head trauma or surgery, severe hypertension, bacterial endocarditis, etc.
* Creatinine clearance \< 90 mL/min as estimated using Cockcroft-Gault formula at screening or baseline
* History of any renal disorders, proteinuria, hepato-biliary disease.
Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine

The purpose of this study is to observe the occurrence of adverse events, seroconversion rate and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
* Participant is aged ≥ 1 year to ≤ 7 years
* Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster
* Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
* Body temperature ≤ 37.5℃

Exclusion Criteria:

* Known allergy to any constituent of the vaccine
* Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever
* Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
* Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
* Failed to the Expanded Programme on Immunization(EPI)
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination
* Plan to receive any vaccine in the 4 weeks following the trial vaccination
* Known bleeding disorder
* Receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination
* Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination
* An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial
* Participation in any other interventional clinical trial
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
Effect of Periodized Resistance Training and High Intensity Training on BMI and QOL in PCOS

This study may help to improve strength and body composition in females with PCOS. It will enhance ability of an overweight individual to perform functional tasks (i.e. daily living tasks or physical activity) to be physically active. This may facilitate the adoption of a more active lifestyle, thereby increasing the likelihood of success in overall weight-reduction strategies.

Poly cystic ovarian syndrome (PCOS) is a hormonal disorder which is most common in females with fertile age. A number of small fluid filled sacs formed in ovaries which results in failure of egg release. Poly cystic ovary syndrome (PCOS) is an endocrine problem which is characterized by the polycystic ovaries, menstrual problems, infertility, metabolic disorder, psychological problems, elevated androgens, hirsutism, acne and obesity. PCOS also causes psychological disorders which include depression, anxiety, poor body image, low self-esteem and decreased health- related quality of life. Some well-controlled randomized clinical studies have been conducted to evaluate the effects of exercise training program in women with PCOS. There are many beneficial effects of exercises which improve physical fitness, body composition, and cardiovascular, hormonal, reproductive and psychological outcomes. Periodization training program involves period of active rest which allows muscle adaptations through variable intensity, volume and rest. The advantage of periodization is that it prevent from overtraining symptoms such as muscle stiffness, muscle soreness, sprain, strain, possible injury and decreased performance. High intensity interval training is effective in reducing body mass index and improving body composition in females with PCOS.

The study will be a randomized clinical trial and will be conducted in Mohsin memorial hospital Faisalabad. This study will be completed in time duration of ten months after the approval of synopsis and convenient sampling technique will be used. Total twenty four subjects will be assigned randomly by using lottery method into two groups. Group A will receive periodized resistance training and Group B will receive high intensity interval training. Warm up and cool down period of ten minutes of treadmill training will be performed by both groups. Data will be collected from all participants at baseline and after 8 weeks of treatment by using BMI and WHO-QOL BREF questionnaire. After assessing the normality data will be analyzed by using parametric or non-parametric test by using SPSS-25.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-35 years
* Unmarried females
* Diagnosed patients of PCOS
* All women who are less physically active or have sedentary life style.
* BMI\>25kg/m2 (overweight obese)

Exclusion Criteria:

* Use of hormonal contraceptives.
* Diabetes
* Hypertension
* Thyroid disease
* Cushing disease
* Any physical disability
Identifying Challenges to Healthy Aging in Persons With Human Immunodeficiency Virus (HIV) Age 50 and Older

The primary objective of this study is to identify and characterize frailty and pre-frailty in persons age 50 and older living with human immunodeficiency virus (HIV) followed by the Atrium Health Wake Forest Baptist Infectious Diseases Specialty Clinics (IDSC).

The study will implement electronic medical record-based screening for frailty (eFI), further characterize frailty using comprehensive geriatric screening, and offer a customized activity and nutrition plan to a subset of participants. Participation in phlebotomy for research biomarkers of aging is optional. The study also seeks to validate the electronic medical record embedded electronic frailty index (eFI) for the prediction of adverse outcomes in aging persons with HIV, characterize the symptoms of pre-frailty and frailty in persons followed in the IDSC, and assess the acceptability and efficacy of a customized activity and nutrition intervention targeting frailty. The study will also correlate research biomarkers of aging with aging symptoms in a subset of participants.

Eligibility Criteria:
Inclusion Criteria:

* Person living with human immunodeficiency virus (HIV)
* Age ≥50 years
* Followed by the Atrium Health Wake Forest Baptist Infectious Diseases Specialty Clinic (IDSC)
* Eligible for Ryan White Program
* Able to provide informed consent
* Pre-frail or frail by electronic frailty index (eFI)

Exclusion Criteria:

* Age \<50 years (study designed to characterize frailty in aging persons with HIV)
* Unable to complete the required assessments or questionnaires
Pharmacokinetic Study of Docetaxel-PNP and Taxotere to Treat Patient With Advanced Solid Cancer

Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC and Cmax

Comparison of pharmacokinetic parameters (T1/2β, CL, Vdss) Safety as measured by adverse events

Eligibility Criteria:
Inclusion Criteria:

* Patient ages more than 18 years old
* Patient should voluntarily sign a written informed consent before study entry
* Patient historically or cytologically confirmed diagnosis of advanced solid tumor and patient with measurable disease or evaluable disease by RECIST criteria
* Progressive disease with development of new lesions or an increase in preexisting lesions or standard therapy in order to provide clinical benefit does not exist or is no longer effective
* Previous anti-cancer therapies must be completed before 21days of first study dose and Patient must have recovered from any previous therapy
* Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Patient has a life expectancy of at least 3 months
* Baseline studies for determining eligibility must be completed within 14 days of first study dose and patient has a adequate organ function including the following:

  * Hb ≥ 10g/dl
  * ANC ≥ 1.5 X 109/L
  * Platelet count ≥ 100 X 109/L
  * Serum total bilirubin ≤ 1.5 mg/dL
  * Serum AST and ALT ≤ 2.5 X UNL
  * Serum ALP ≤ 2.5ⅹUNL
  * Serum creatinine ≤ 1.5 X UNL

Exclusion Criteria:

* Patient has had a major surgery except tumor ablation within 2 weeks before screening visit
* Patient has a brain metastasis with neurologic symptom
* Patient has a sensory neuropathy or motor neuropathy ≥ grade 2 by NCI-CTCAE
* Patient has any serious concurrent disease such as:

Any medical or psychiatric condition that, in the opinion of the investigator, would prohibit the understanding and giving of informed consent Severe cardiovascular disease (e.g. ischemic heart disease requiring medication or myocardial infraction within the past six months, grade 3-4 congestive heart failure defined by the New York Heart Association criteria) Active un controlled infection.

* Patient has hypersensitivity to the Investigational product or their excipients
* Patient has participated in any other clinical trial within 4 weeks before screening visit
* Woman is pregnant or breast feeding
* Subjects who are of childbearing potential who do not use a medically acceptable method of birth control or do not agree to continue use of this method throughout the trial (screening, treatment period, and 3 weeks from the last done). A negative pregnancy test (urine or serum) should be documented within 14 days prior to initiation of trial medication for women of childbearing potential who have not been amenorrheic for at least 12 months prior to registration into the trial or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). Medically acceptable methods include:

  * Barrier method with spermicide
  * Intrauterine device
  * Complete abstinence, etc.