cyrilzakka/clinical-trials huggingface dataset:
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).


Eligibility Criteria:
Inclusion Criteria:

* Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
* Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
* Patient meets protocol criteria for diagnosis of IBS-C
* Patient demonstrates continued IBS-C through Pretreatment Period
* Patient is compliant with IVRS

Exclusion Criteria:

* Patient has history of loose or watery stools
* Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
Volumetric Study of Fat Resorption After Breast Lipofilling

Prospective observational study to evaluate effects on washing to improve viability of fat grafts in breast lipofilling.


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast defect post breast surgery and unsatisfied. The first lipofilling procedure delayed for at least 9 months after the completion of radiotherapy. Patient on chemotherapy deferred until at least 6 month of last chemotherapy.

Exclusion Criteria:

* Patients are excluded if they experienced local recurrence or distant metastasis
A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.


Eligibility Criteria:
Inclusion Criteria:

* KRAS and NRAS wild type metastatic colorectal cancer
* Progression following treatment for colorectal cancer with irinotecan, oxaliplatin and fluoropyrimidine therapy in the metastatic setting.
* Eastern Cooperative Oncology Group \[ECOG\] Performance Status of 0, 1, or 2
* At least one measurable lesion by Response Evaluation Criterion in Solid Tumors \[RECIST\]

Exclusion Criteria:

* More than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer.
* Prior treatment with a PI3K, mTOR, AKT or EGFR inhibitor
* Patients who have discontinued treatment with prior irinotecan therapy due to toxicity.
* Prior radiation to the pelvis or abdomen
* Patients with history of interstitial lung disease.
Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.

Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In retinopathy of prematurity (ROP).

Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.


Eligibility Criteria:
Inclusion Criteria: stage 2+ or stage 3+ Retinopathy of prematurity in Zone I or Zone II.

Informed written consent by parents or guardian.

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Exclusion Criteria:

Refusal to give consent Critically ill neonates.

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The Use of Social Media Platform to Continuously Support Pregnant Women With Gestational Diabetes Mellitus

To assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control in patients with gestational diabetes mellitus (GDM), compared to the control group under usual care. Specifically,

i. To measure the participants' acceptability and satisfaction levels of receiving intervention through the social media platform.

ii. To measure the feasibility of using the social media platform to provide GDM support through participants' engagement levels and feedback questionnaire.

iii. To measure the efficacy of using the social media platform to manage emotional responses in women with GDM.

iv. To measure the efficacy of using the social media platform to optimize glycemic control in women with GDM.

Engaging pregnant women with GDM in dietary management over the gestation has been challenging. This pilot trial aims to assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control among patients with GDM, compared to a control group receiving usual care. The study will employ a randomized controlled trial design, with GDM patients from KK Women's and Children's Hospital (KKH) randomly assigned to either the usual care (control; n=40) or to additional support via a dedicated social media platform for a period of 1 month, where a moderator will be available to address patients' queries and share relevant educational resources (intervention; n=40). Outcome measures include acceptance, satisfaction, and engagement levels, emotional well-being as well as the percentage achievement of time-in-range glucose readings for GDM patients. The independent t-test will be used to compare the outcome measures between groups. The findings from this study will provide valuable insights into the feasibility and efficacy of incorporating digital platforms into routine dietary counselling practices for improved patient outcomes and enhanced management of GDM.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with GDM as confirmed by the Oral Glucose Tolerance Test during pregnancy
* Age ≥ 21 and ≤ 45 years
* Attended first (baseline) session of GDM diet counselling session
* Able to read and comprehend English
* Have a digital device accessible to social media platform
* Have SingPass access
* Able to provide informed consent

Exclusion Criteria:

* With known Type 1 or Type 2 diabetes
* Have multiple pregnancy
Capsaicin in Treatment of Rhinogenic Headache

Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis. We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches, in addition to the previously studied decongestive effects. This study aims to evaluate capsaicin impact on headaches attributed to V1, V2 distribution of the sinonasal cavity. This study is a randomized, double-blinded, parallel trial.

1. Title: The role of capsaicin in treatment of rhinogenic headache
2. Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis, migraines and cluster headaches. We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches as well. This study aims to evaluate capsaicin impact on headaches attributed to the nose and paranasal sinus distribution.
3. Interventions, evaluations, and follow-up: Subjects are recruited from an Otolaryngology clinic, where a formal headache questionnaire is administered in-office, and standard endoscopy is performed in office to rule out confounding causes of headache and sinonasal disease. Written instructions are provided and consent obtained. A symptom journal is provided. Subjects are randomly selected to receive two bottles of either eucalyptol spray (placebo) or sinus buster (capsaicin) spray and are blinded to the content of the spray bottle. They are instructed to use the nasal spray one to two times daily. Subjects are permitted to continue to take headache medication as needed, but it must be recorded in their symptom journal. The journal is completed daily, and includes medication use, a headache pain score, and side effect log. Additionally, subjects fill out SinoNasal Outcome test (SNOT)22 at 2 weeks, 4 weeks, and 8 weeks. Weekly emails are sent to remind subject to fill out their journal. A phone call is made to the subject to survey them on progress at 2 and 6 weeks. Follow up visits are scheduled at 4 weeks and 8 weeks, or sooner if problems arise. A standard nasal endoscopy is performed at the first and last visit.
4. Additional data that would be tracked: Quality of life score as measured by SNOT-22 scores, treatment failure and drop-outs, and objective changes in sinus endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Consenting Adults aged 19-100 presenting to the Otolaryngology DepartmentofUniversityof Nebraska Medical center complaining of headaches/ facial pain and pressure Diagnosis of a primary rhinogenic headache disorder by the senior authors.

Exclusion Criteria:

* Exclusion criteria include: pregnancy, age less than 19, active history of smoking, presence of confirmed sinonasal disease, fibromyalgia, poorly controlled chronic health problems, allergies to chili peppers or any ingredient in the nasal spray, or confirmed Temporal Mandibular Joint (TMJ) arthralgia as the etiology of primary headache.
Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy

The purpose of this study is to investigate the effect synchronous use of nivolumab in addition to chemoradiotherapy in patients withnon-metastatic MIBC who are not candidates for radical cystectomy

The initial hypothesis is that addition of nivolumab will increase 2-year locoregional control rate from 55% (control arm) to 75% (immunotherapy arm)

There is a 24 month accrual period during which 78 patients will be randomized in a control group (standard chemo-radiotherapy) and the treatment group (chemo-radiotherapy + Nivolumab)

The primary objective would be to compare locoregional control rate at 2-years between patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy.

The secondary objectives are

1. To study the safety of the addition of nivolumab to chemoradiotherapy in patients with MIBC
2. To compare 2-year bladder cancer failure-free (BCFF) rates, defined as distant metastasis free survival (MFS) AND/OR locoregional failure (defined as in primary objective)
3. To compare median overall survival (OS) in patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy
4. Assess the effect of combined treatment on the quality of life

Correlative studies of outcomes with PD-L1expression and with lymphocytic populations in the environment of the tumor

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven, muscle-invasive carcinoma of the bladder, cT2-T4aN0M0
* Urothelial, squamous or glandular histology according to WHO 2016 classification (Fig 1)
* Undergone a vigorous TURB
* Not candidates for radical cystectomy.
* PS:0-1
* age \>18 years old
* Adequate bone marrow function
* Adequate renal function

Exclusion Criteria:

Key Exclusion Criteria

* Histology other than transitional-cell, squamous or adenocarcinoma
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer cervix or breast.
* Previous systemic chemotherapy or prior biologic agents within 4 weeks, or intravesical Bacillus Calmette-Guerin (BCG) within 6 weeks of the first dose of study treatment.
* Prior treatment with any PD-1 or PDL-1 inhibitor or anti CTLA4 agent
* Previous pelvic radiation therapy.
* Patients with inherited syndromes associated with hypersensitivity to ionizing radiation
* Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation
* Any history of inflammatory bowel disease and or history of abdominal fistula
* Previous allergy to any of the study drugs
A Study of HGS1036 in Combination With Chemotherapy in Subjects With Advanced Solid Malignancies

The primary purpose of this study is to determine the maximally tolerated dose (MTD) of HGS1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus carboplatin, cisplatin plus etoposide, or docetaxel.

This study will consist of 3 regimens each containing 2 dose levels of HGS1036 and full dose chemotherapy. Patients will be treated in sequence with HGS1036 at planned dose levels of 10 mg/kg and 20 mg/kg. Patients who demonstrate stable disease or better may continue to receive HGS1036 until progressive disease, unacceptable toxicity, patient requests discontinuation of study treatment, or the Investigator feels further treatment is not in the patient's best interest. After discontinuation of HGS1036, subjects will be followed for 30 days after the last dose of HGS1036 for safety. The end of study will be defined as 1 year after the last subject begins treatment of HGS1036. Any subject still receiving HGS1036 at this pre-defined end of study, may continue to receive HGS1036, but the only study assessments required will be for safety.

Eligibility Criteria:
Inclusion Criteria:

* Have a histological or cytological diagnosis of malignant solid neoplasm requiring systemic chemotherapy.
* Age ≥18 years.
* ECOG performance status 0-1.
* Adequate organ function.
* Adequate hematological function.
* Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.
* Consent to collection of previously obtained, archival biopsy or surgical specimens of the currently treated malignancy when available.

Exclusion Criteria:

* Significant cardiac disease.
* Eye trauma or disease.
* Ocular surgery or blunt force trauma to the eye requiring treatment within 3 months prior to first dose of HGS1036.
* Presence or history of ≥ Grade 2 hemoptysis within 2 weeks of the first dose of HGS1036.
* Major surgery within 4 weeks of the first dose of HGS1036.
* Prior organ or allogeneic stem cell transplant.
* Non-healing or chronic wounds.
* Receipt of any anti-cancer therapy within 4 weeks prior to first dose of HGS1036.
* Receipt of any biological therapy (such as monoclonal antibodies) within 6 weeks of the first dose of HGS1036.
* Active CNS involvement by primary or metastatic tumor.
* Documented active infection requiring the use of systemic antibiotics.
* Pregnancy or lactation.
* Known HIV-positive serology, AIDS, or an AIDS-related illness.
* Conditions likely to increase the potential for abdominal perforation or fistula formation.
Study for Promotion of Health in Recycling Lead

Study for Promotion of Health in Recycling Lead (SPHERL) is a prospective 2-year follow-up study of lead workers with exposure levels varying between and within individuals. SPHERL addresses to what extent between-subject differences or within-subject changes in lead exposure may have a measurable impact on blood pressure, the cardiovascular system, renal function, the autonomic nervous system, peripheral nervous conduction velocity, and neurocognitive function.

At the beginning of December 2015, 70 participants were included in the study.

Background

* Whether low-level lead exposure impacts on blood pressure, regulation of the cardiovascular system, glomerular or tubular renal function, sympathetic nervous modulation, peripheral nervous conduction velocity, and neurocognitive function remains uncertain.

Study Population

* SPHERL will enroll 500 lead recycling workers with changing lead exposure, who will be examined at baseline (2014-2015) and followed up at annual intervals for 2 years (2016-2017).

Methods

* Volunteers eligible for the study are (i) new and existing hires without previous occupational lead exposure who will be performing tasks with or without occupational lead exposure and (ii) existing hires with occupational lead exposure who will be transitioning to job tasks without occupational lead exposure within the next 2 years.
* Blood lead concentration will be the main biomarker of exposure.
* The main outcome variables are (i) blood pressure measured conventionally and by ambulatory monitoring, and analyzed as continuous or categorical variable, both cross-sectionally and longitudinally; (ii) indexes of glomerular and tubular renal function, (iii) heart rate variability analyzed in the frequency domain as measure of autonomous sympathetic modulation, (iv) peripheral nerve conductivity, (v) neurocognitive performance, (vi) and quality of life \[the EuroQOL five dimensions (EQ-5D) questionnaire\].

Expected Outcomes

* Assuming a 4-fold or higher surge in the blood lead concentration, the study is powered to demonstrate over 2 years an acceleration in the age-related rise of systolic blood pressure by 1 to 4 mm Hg or an increase of the coefficient of multiple determination (R2) from 0.22 to 0.24 by adding the change in the blood lead concentration to models relating changes in blood pressure to three other covariables. The longitudinal design of our study complies with the temporality principle of the Bradford-Hill criteria for assessing possible causality between outcomes and exposure.

Eligibility Criteria:
Inclusion Criteria:

* Women and men are eligible.
* New hires without previous occupational lead exposure who will be performing tasks with lead exposure or current employees without previous occupational lead exposure moving to tasks with exposure.
* Informed written consent.

Exclusion Criteria:

* Pregnancy.
* Any serious health condition.
The Effect of Fibromyalgia Syndrome Accompanying Obstructive Sleep Apnea Syndrome on Clinical Findings

Fibromyalgia Syndrome (FMS) is a chronic disease that lasts for at least three months and is characterized by various symptoms such as tender points, widespread pain in the musculoskeletal system, sleep disturbance and fatigue. Obstructive sleep apnea (OSAS) is a disease characterized by repeated upper airway obstruction during sleep. Sleep disorders negatively affect the lives of individuals. The prevalence of OSAS is between 1-5% in studies and it is more common in men than in women. Fatigue, anxiety, depression and sleep disturbance are also common in patients with fibromyalgia. Likewise, the presence of symptoms such as musculoskeletal pain in patients with OSAS suggests that these two diseases may be related to each other. We planned this study to show the relationship between OSAS and fibromyalgia (FM).

Our research will be carried out on patients diagnosed with OSAS after being evaluated in the sleep laboratory of the Research Hospital Department of Chest Diseases. Fibromyalgia screening will be performed on participants who are diagnosed with OSAS and accepted to participate in the study. Patients with FM according to the 2010 American College of Rheumatology diagnostic criteria will be divided into two groups as FM patients (case group) and patients who do not meet these criteria (control group). Sleep laboratory results and demographic data of all patients will be recorded. In addition, anxiety, depression and fatigue levels will be evaluated with scales. Fibromyalgia impact questionnaire will be applied to fibromyalgia patients. Our study is a cross-sectional prospective case-control study. It is not a treatment research, an interventional application will not be made to the patients.

Our hypothesis is that OSAS patients with FMS may have more fatigue, anxiety, depression, lower algometer values, and more severe OSAS findings in polysomnographic data.

Eligibility Criteria:
Inclusion Criteria:

1.18-60 years old 2. Diagnosed with OSAS in sleep laboratory examinations 3. Agree to participate in the study

Exclusion Criteria:

1. Pregnancy
2. Neuropsychiatric disease
3. Inflammatory Rheumatic Diseases
4. Morbid obesity
5. Using a device with a previous diagnosis of OSAS
Dose Confirmation Efficacy Study (V260-007)

This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.

The duration of treatment is 10 months.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants

Exclusion Criteria:

* History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
* Known or suspected problems with immune system
* Fever at time of immunization
* Prior administration of a rotavirus vaccine
* History of known prior rotavirus disease
* Chronic diarrhea, or failure to thrive
Risk Management Plan (RMP) Survey for Purchasers of Alli® (60 mg Orlistat) in the European Union.

Following results from the first survey that forms part of the EU RMP for Alli® (RMP survey 1; WEUSRTP3350), several amendments to the information included on the pack carton for Alli® (orlistat 60 mg) were recommended. The main finding from RMP survey 1 was that a large proportion of Alli® users had a body mass index (BMI) less than (\<)28 kg/m2 . (Note: the European indication for Alli® is adults 18 years and older with a BMI\<28 kg/m2.) The proportion of respondents overall who reported possible contraindications to Alli® use was relatively low. The following changes to the pack labeling were agreed and have been implemented: : (1) a statement, highlighting the product is only for those with a BMI of 28 or above was added to the front of the pack; (2) wording of the BMI statement on the back of the pack was strengthened; (3) contraindications were highlighted in bold text; (4) the statement that Alli® is not for use by those under 18 years of age was modified for clarity. In addition, a pharmacy reminder card was made available to retail pharmacists to improve awareness of the prescribing information for Alli®. The survey will assess whether compliance with the authorized indication and contraindications among purchasers of Alli® has been improved after one year of marketing the revised pack labeling.


Eligibility Criteria:
Inclusion Criteria:

* Any individual who purchases Alli from a pharmacy for their own personal use and provides consent.

Exclusion Criteria:

* No exclusion criteria.
Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease

To identify key characteristics of the tissue resident and peripherally circulating immune-phenotype in addition to blood markers, metabolic profile, faecal and oral microbiota in non-alcoholic fatty liver disease

In this study, the investigators will collect tissue, blood, stool, urine and saliva samples at the same time in order to enable a comprehensive disease phenotyping and ability to compare immunological, microbiological and metabolic features in patients with varying stages of NAFLD and healthy controls. To date there are limited published data evaluating simultaneously-obtained samples from adipose, gut and liver tissue and peripheral blood in NAFLD. The majority of participants in this study will be recruited from the bariatric surgery services enabling multiple tissue samples to be collected at time of surgery with minimal additional risk to participants.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Confirmed non-alcoholic Fatty liver disease (diagnosed clinically, radiologically or histologically)
* If diabetic, Diagnosed with Type 2 Diabetes Mellitus

OR

• Healthy Control: no diagnosis of any liver condition including NAFLD

o NAFLD excluded by Fibroscan Controlled Attenuation Parameter (CAP) score of \<222 dB/m

Exclusion Criteria:

* Unwilling or unable to give informed consent
* Type 1 Diabetes Mellitus
* Other form of liver disease (other than NAFLD)

  o Viral hepatitis, Auto-immune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, Sarcoidosis, cystic fibrosis, sickle cell disease
* Taking medication associated with liver dysfunction (except methotrexate)
* Auto-immune disease which in the investigator's opinion may confound immune profiling
* Concomitant immunosuppressive medications (except methotrexate, short course oral steroids or inhaled corticosteroids)
* Currently pregnant
* Any major organ transplant (excluding corneal or hair transplant)
* Regular alcohol intake greater than 14 units a week for female participants and 21 units a week for male participants